analysis plan assignment connecticut, united states •study

ClinicalTrials.gov Search Results 12/06/2021

NCT Number Title Status StudyResults

Conditions Interventions Characteristics Population Sponsor/Collaborators Locations

1 NCT05145309 Value of Potassium MagnesiumCitrate in Preventing and TreatingHypertension in African Americans

Study Documents:

•Study Protocol and StatisticalAnalysis Plan

Not yetrecruiting

No ResultsAvailable

•Hypertension •Drug: KMgCit

•Drug: Placebo

Phase:

Phase 2

Study Design:

•Allocation: Randomized

•Intervention Model: CrossoverAssignment

•Masking: Double (Participant,Investigator)

•Primary Purpose: Treatment

Outcome Measures:

•24-hour systolic blood pressure(24h SBP)

•central systolic blood pressure(cSBP)

•pulse wave velocity

•augmentation index

•FGF23

•klotho

Enrollment:

45

•University of TexasSouthwestern MedicalCenter

•University of Texas SouthwesternMedical Center, Dallas, Texas,United States

- of 67 -

https://ClinicalTrials.gov/show/NCT05145309



https://ClinicalTrials.gov/ProvidedDocs/09/NCT05145309/Prot_SAP_000.pdf




2 NCT05143892 Study on Avatrombopag for thePromotion of Platelet EngraftmentAfter Allo-HSCT

Study Documents:

•Study Protocol, Statistical AnalysisPlan, and Informed Consent Form

Not yetrecruiting

No ResultsAvailable

•PLT After AllogenicHematopoietic Stem CellTransplantation

•Drug: Avatrombopag

•Drug: rhTPO

Phase:

•Phase 2

•Phase 3

Study Design:


•Intervention Model: ParallelAssignment

•Masking: None (Open Label)


Outcome Measures:

•Percentage of participantswhose PLT reaches # 20*109/L without the need for PLTtransfusion.

•Percentage of participantswithout PLT response

•Percentage of participants withPLT# 50*109/L without the needof PLT transfusion

•The time to achieve PLT #20*109/L without the need ofPLT transfusion

•Proportion of participantsachieving platelet reconstitution

•Volume of PLT transfusion

•Hematopoietic reconstructioncondition

Enrollment:

78

•The First AffiliatedHospital of SoochowUniversity

- of 67 -




https://ClinicalTrials.gov/ProvidedDocs/92/NCT05143892/Prot_SAP_ICF_000.pdf




3 NCT05143489 The Effect of Pretreatment WithIntravenous Lidocaine for IntravenousContrast:

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Pain •Drug: Preservative FreeLidocaine

•Drug: Saline

Phase:

Phase 4

Study Design:



•Masking: Quadruple (Participant,Care Provider, Investigator,Outcomes Assessor)


Outcome Measures:

•Pain score at 15 minutes postmedication administration





Enrollment:

80

•Antonios Likourezos

•Maimonides MedicalCenter

•Maimonides Medical Center,Brooklyn, New York, United States

4 NCT05139407 Experimental Intervention on theInfluence of Six Weeks' ContentKnowledge on Students' Written TestAchievement

Study Documents:

•Study Protocol

Completed No ResultsAvailable

•Educational Problems

•Student Burnout

•Diagnostic Test:Teaching intervention

Phase:

Not Applicable

Study Design:



•Masking: Triple (Participant,Investigator, OutcomesAssessor)

•Primary Purpose: Other

Outcome Measures:

Students' written testachievements

Enrollment:

26

•Universiti PutraMalaysia

•China, Ningxia ,Ningxia University,Yingchuan, Ning Xia, China

- of 67 -










https://ClinicalTrials.gov/ProvidedDocs/07/NCT05139407/Prot_000.pdf



5 NCT05131360 Reducing Daily Stress Among Sexualand Gender Minorities

Study Documents:


Recruiting No ResultsAvailable

•Social Discrimination

•Sexual and GenderMinorities

•Mindfulness

•Behavioral: IntroductionOnly

•Behavioral: Purpose Only

•Behavioral: ConnectionOnly

•Behavioral: Connectionand Purpose

•Behavioral: AwarenessOnly

•Behavioral: Awarenessand Purpose

•Behavioral: Awareness,Purpose, and Connection

•Behavioral: Awarenessand Connection

Phase:

Not Applicable

Study Design:


•Intervention Model: FactorialAssignment

•Masking: Single (Participant)

•Primary Purpose: SupportiveCare

Outcome Measures:

•Change from Baseline inPerceived Stress on thePerceived Stress Scale at Day 5

•Change from Baseline inSatisfaction with Life on theSatisfaction with Life Scale atDay 5

•Optimized Intervention Package

Enrollment:

80

•New York University •New York University School of GlobalPublic Health, New York, New York,United States

6 NCT05130814 EmoLED Medical Device Treatmentof Second and Third Stage PressureUlcers

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Pressure Sore

•Pressure Ulcer

•Pressure Ulcers Stage III

•Pressure Ulcers Stage II

•Device: blue lightphotobiomodulation

•Procedure: cleansing

•Combination Product:hyaluronic acid gauzeplus polyurethane foam

•Drug: zinc cream orhyaluronic acid sodiumsalt + metallic silver

•Procedure: topicaltreatment

•Procedure: bandage

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Ulcers' clinical state

•Reduction of the lesion surfacein both arms, measured as % ofthe initial size.

•Number of Treatment-EmergentAdverse Events

Enrollment:

40

•Emoled

7 NCT05129501 The Impact of an Adapted Version ofthe Strengthening Families Programon IPV Among Caregivers and ACEsAmong Children

Study Documents:

•Statistical Analysis Plan


•Adverse ChildhoodExperiences

•Domestic Violence

•Behavioral: Experimental Phase:

Not Applicable

Study Design:




•Primary Purpose: Prevention

Outcome Measures:

•Adverse Childhood Experiences

•Conflict Tactic Scale

Enrollment:

300

•University of NebraskaLincoln

•Bennington College

•Centers for DiseaseControl andPrevention

•Rapid City Family Project Office,Rapid City, South Dakota, UnitedStates

- of 67 -














https://ClinicalTrials.gov/ProvidedDocs/01/NCT05129501/SAP_000.pdf



8 NCT05128396 Successful Aging and Enrichment(SAGE)

Study Documents:

•Study Protocol

Active, notrecruiting

No ResultsAvailable

•Cognitive Health

•Healthy Aging

•Behavioral: CognitiveStimulation

•Behavioral: Mindfulnesstraining

•Behavioral: PhysicalActivity

•Behavioral: ControlGroup

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Cambridge NeuropsychologicalTest Automated Battery(CANTAB), a computerizedassessment of cognitivefunctions

•Trail Making Test A

•Trail Making Test B

•Digit Symbol Coding, WeschlerAdult Intelligence Scale (WAIS-IV)

•Controlled Oral WordAssociation Test (COWAT)

•Categorical Fluency

Enrollment:

72

•Brigham and Women'sHospital

•Linnaeus University

•Brigham and Women's Hospital,Boston, Massachusetts, UnitedStates

- of 67 -






9 NCT05125133 Evaluation of Insecticide-treated EaveNets and Window Screens for MalariaControl in Tanzania.

Study Documents:

•Study Protocol and InformedConsent Form


•Malaria,Falciparum •Other: ITENs + ITWS Phase:

Not Applicable

Study Design:





Outcome Measures:

•Prevalence of Plasmodiumfalciparum parasite.

•Clinical malaria.

•The density of malaria vectorsand nuisance mosquitoesdensity.

• ITENs & ITWS fabric cost

•ITENS & ITWS time duration

•Adverse effects

•Attrition

•Fabric integrity

•The induced mosquito mortalityof ITENs and ITWs on thepopulation of laboratory-rearedmosquitoes.

•Insecticide retainment

•Use of ITENs and ITWS

Enrollment:

1800

•Ifakara Health Institute

•London School ofHygiene and TropicalMedicine

•Swiss Tropical &Public Health Institute

•Vector Control Product Testing UnitFacility, Bagamoyo, Tanzania

- of 67 -




https://ClinicalTrials.gov/ProvidedDocs/33/NCT05125133/Prot_ICF_000.pdf




10 NCT05123300 PRISMA-PET - Primary Staging ofProstate Cancer With PSMA

Study Documents:



•Prostate Cancer •Diagnostic Test: 18F-PSMA-1007

Phase:

Not Applicable

Study Design:




•Primary Purpose: Diagnostic

Outcome Measures:

•Treatment Strategy (Group A vs.B)

•Progression Free Survival(Group A vs. B)

•Quality of life according toquestionnaires (Group A vs. B)

•Accuracy NaF-PET/CTcompared to PSMA-PET/CT fordetection of metastases

•Value of PSMA/MR for tumorstaging and detection of lymphnode and bone metastases inthe pelvis.

Enrollment:

448

•Odense UniversityHospital

•Sygehus Lillebaelt

•Hospital of South WestJutland

•Department of Radiology and NuclearMedicine, Esbjerg, Denmark

•Department of Nuclear Medicine,Odense, Denmark

•Department of Nuclear Medicine,Vejle, Denmark

11 NCT05122780 Prognostic Value of PrecisionMedicine in Patients With MINOCA(PROMISE Trial).

Study Documents:



•Myocardial InfarctionWith Non-ObstructiveCoronary Arteries

•Procedure: Coronaryangiography

•Diagnostic Test: OCTimaging

•Procedure: Percutaneouscoronary intervention(PCI):

•Diagnostic Test:Acetylcholine provocativetest

•Diagnostic Test: TT-Echocardiography

•Diagnostic Test:TE/contrastechocardiography

•Diagnostic Test: Cardiacmagnetic resonance

•Diagnostic Test:Circulating biomarkers

•Drug: Antiplatelet Drug

•Drug: Statin

•and 5 more

Phase:

Phase 4

Study Design:





Outcome Measures:

•Angina status

•Quality of life

•Rates of major adversecardiovascular events

•Healthcare primary related-costs

•Healthcare secondary related-costs

•Ability of different circulatingbiomarkers as diagnosticbiomarker and stratification toolfor specific causes of MINOCA.

•Ability of CMR in evaluatingdifferent mechanisms ofMINOCA and their prognosticvalue through morphologicaland functional cardiaccharacterization.

Enrollment:

180

•Fondazione PoliclinicoUniversitario AgostinoGemelli IRCCS

•Centro CardiologicoMonzino

•IRCCS Policlinico S.Donato

•Centro Cardiologico Monzino, Milan,Italy

•Fondazione Policlinico UniversitarioA. Gemelli IRCCS, Rome, Italy

•IRCCS Policlinico San Donato, SanDonato Milanese, Italy

- of 67 -












12 NCT05122676 More Individualized Care: Assessmentand Recovery Through Engagement

Study Documents:

•Study Protocol

Not yetrecruiting

No ResultsAvailable

•Depression

•Anxiety

•Opioid-Related Disorders

•Pain, Chronic

•Behavioral: MoreIndividualized Care:Assessment andRecovery throughEngagement (MI-CARE)

Phase:

Not Applicable

Study Design:



•Masking: Double (Investigator,Outcomes Assessor)


Outcome Measures:

•Days of buprenorphinemedication treatment for opioiduse disorder (OUD)

•Change in depressive symptoms

Enrollment:

800

•Kaiser Permanente

•Indiana UniversityHealth

•National Institute ofMental Health (NIMH)

•Boston Medical Center

•University of NewMexico

•University ofWashington

•Purdue University

•Indiana University Health,Indianapolis, Indiana, United States

•Kaiser Permanente WashingtonHealth Research Institute, Seattle,Washington, United States

13 NCT05115799 Effects of a Manual Therapy Programto Reduce the Evolution Time ofAxillary Web Syndrome.

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Breast Cancer

•Mastectomy;Lymphedema

•Thrombi

•Thrombosis

•Shoulder Syndrome

•Movement Disorders

•Other: Manual Therapy,Physiotherapy,Kinesiology, ScarMassage

•Other: Kinesiotherapy,Physiotherapy, HealthEducation

Phase:

Not Applicable

Study Design:



•Masking: Single (Investigator)


Outcome Measures:

•Shoulder Range of Movement(ROM) in the limb with AxillaryWeb Syndrome

•Quality of life. Barthel Scale

•Shoulder Functionality

•Shoulder Pain. Visual AnalogicScale (VAS)

Enrollment:

46

•University of Malaga

- of 67 -











14 NCT05114382 An Evaluation of the Safety andPerformance of the CathVision Cube®System

Study Documents:

•Study Protocol


•Cardiac Arrhythmia •Procedure: EP Procedure Phase:

Not Applicable

Study Design:

•Allocation: N/A

•Intervention Model: Single GroupAssignment



Outcome Measures:

•Freedom from major adverseevents, evaluated at hospitaldischarge.

•Recording low-voltageelectrograms

•The Primary Performanceendpoint of study will beevaluated as technical successof CathVision Cube® system tocollect and record intracardiacsignals during EP procedures

•Compatibility of Cube Systemwith commercially available 3Dmapping system

Enrollment:

24

•CathVision ApS

•TRIQ GROUP Wherry& Klaffke GbR

•IKEM, Institue of Clinical andExperimental Medicine, Prague,Czechia

•Rigshospitalet, Copenhagen,Denmark

15 NCT05112471 Efficacy of GBT vs SRP+US, in theTreatment of Severe GeneralizedPeriodontitis.

Study Documents:



•Periodontitis, Aggressive

•Periodontal Diseases

•Periodontitis

•Device: Airflow, Perioflowand Erythritol powder andultrasonic debridement

•Device: Ultrasonicdebridement and curettes

Phase:

Not Applicable

Study Design:





Outcome Measures:

•The number of experimentalsites (PPD > 4mm and <10mm)becoming closed pockets (PPD #4mm).

•Change in PPD (periodontaldepth)

•Change in REC (Clinical GingivalRecession)

•Change in CAL (ClinicalAttachment Level)

•Change in BOP (Bleeding onProbing)

•Change in PI (Plaque Index)

Enrollment:

32

•Azienda SocioSanitaria Territorialedegli Spedali Civili diBrescia

•Magda Mensi, Brescia, Lombardia,Italy

- of 67 -












16 NCT05111899 Leading Advancements in the Uptakeof Newborn Community Health

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Breastfeeding, Exclusive

•Immunization; Infection

•Growth; Stunting,Nutritional

•Behavioral: NewbornHealth Education

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Mid-upper arm circumference

•Proportion of mothers exclusivebreastfeeding

•Immunization status

•Frequency of acute illness

•Frequency of hospitalizationstatus

Enrollment:

240


•Frankel FamilyFoundation

•StewardshipFoundation

- of 67 -







17 NCT05110456 To Evaluate the Effectiveness of aVirtual and Telephone Interventionfor the Prevention of PostpartumDepression in Women at Risk

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Depression, Postpartum •Behavioral: Telephonesupport

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change from baseline at 3month postpartum depressivesymptoms: The EdinburghPerinatal/Postnatal DepressionScale (EPDS)

•Depressive symptoms: TheEdinburgh Postnatal DepressionScale (EPDS)

•Change from baseline inGeneralized Anxiety Disorderquestionnaire (GAD-7) score

•Anxiety related to pregnancy:Pregnancy-specific anxiety scale(PRAQ-R2)

•Stress: Perceived Stress Scale(PSS)

•Well-being: WHO-5 (WorldHealth Organization) index

•Self-efficacy: General Self-Efficacy scale (GSE)

•Self-compassion: Self-Compassion Scale (SCS)

•Sleep: Pittsburgh Sleep QualityIndex (PSQI)

•Social Adjustment: SocialAdjustment Scale - Self-report(SAS-SR)

•and 8 more

Enrollment:

500

•St. Justine's Hospital

•St. Justine Foundation

•Canadian MedicalAssociation

•Hewitt Foundation

•St. Justine hospital, Montréal,Quebec, Canada

- of 67 -









18 NCT05108896 Aspiration in Acute Respiratory FailureSurvivors 2

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Dysphagia

•Aspiration

•Diagnostic Test: 3-Screenings Protocol

•Diagnostic Test: FEES

•Diagnostic Test: TrachealUltrasound

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Percentage of participantsexperiencing aspiration on theFEES with any of the feedingconsistencies

•Percentage of participantsexperiencing non-silentaspiration

•Percentage of participantsexperiencing silent aspiration

•Percentage of participantsexperiencing post-extubationclinical laryngeal edema

•Duration of mechanicalventilation

•Duration required for liberationfrom mechanical ventilation

Enrollment:

855

•University of Colorado,Denver

•National Institute ofNursing Research(NINR)

•Stanford Univerity, Stanford,California, United States

•University of Colorado, Aurora,Colorado, United States

•Yale University, New Haven,Connecticut, United States

•Boston University, Boston,Massachusetts, United States

- of 67 -







19 NCT05108558 Efficacy of a Novel CCH Protocol forPD Among Prior Non-responders

Study Documents:



•Peyronie's Disease •Drug: CCH administration

•Drug: Control - Crossoverto CCH

•Device: RestoreX

Phase:

Phase 4

Study Design:



•Masking: Double (Care Provider,Outcomes Assessor)


Outcome Measures:

•Penile Curvature

•Peyronie's DiseaseQuestionnaire Outcomes

•International Index of ErectileFunction Outcomes

•Penile Curvature Compared toBaseline

•Penile Length Compared toBaseline

•Compare Peyronie's DiseaseQuestionnaire to Baseline

•Compare International Index ofErectile Function to baseline

•Penile Length Between Groups

•Adverse events - 6 months -pain, sensation, swelling

•Adverse events - 12 months -pain, sensation, swelling

•Change in penile curvaturedurability

Enrollment:

40

•Charitable Unionfor the Researchand Education ofPeyronie's Disease

•The Male Fertility and Peyronie'sClinic, Orem, Utah, United States

- of 67 -







20 NCT05106959 Piloting a Motivational InterviewingShame-Resilience Training

Study Documents:



•Shame •Behavioral: MotivationalInterviewing InformedShame ResilienceTraining

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Willingness to Communicate

•Adult Trauma SymptomChecklist

•Shame Compass

•WHO Big 5 Subjective Well-Being

•Shame Resilience AmongstMental Health Trainees

Enrollment:

19

•University of NewMexico

•South-East Heights Clinic,Albuquerque, New Mexico, UnitedStates

21 NCT05106816 The Effects of Vibrotactile Stimulationin Patients With Movement Disorders

Study Documents:



•Parkinson Disease

•Essential Tremor

•Dystonia

•Other: skin surfacevibration

•Other: light skin surfacevibration- SHAM

Phase:

Not Applicable

Study Design:

•Allocation: Non-Randomized


•Masking: Double (Participant,Outcomes Assessor)


Outcome Measures:

•Quantitative Tremor Assessment

•Functional Dexterity Task (FDT)

•Reaction time task

•Timed-up-and-go (TUG) gait task

Enrollment:

40

•University of Florida

•Parkinson'sFoundation

•Norman Fixel Institute forNeurological Diseases, Gainesville,Florida, United States

- of 67 -











22 NCT05106231 Effectiveness of PICC ImprovingHBA1C and Knowledge in DiabetesMellitus Education

Study Documents:



•Diabetes Mellitus

•Type2 Diabetes

•Behavioral: PICCProgram

•Behavioral: Control

Phase:

Not Applicable

Study Design:



•Masking: Single (OutcomesAssessor)


Outcome Measures:

•HbA1C improvement (HbA1clevel below 42mmol/mol or 6.5%)using finger prick test

•Diabetes knowledgeimprovement (scores inpercentage)

Enrollment:

94

•Clinical ResearchCentre, Malaysia

•Ministry of Health,Malaysia

•Klinik Kesihatan Daro, Daro,Sarawak, Malaysia

•Klinik Kesihatan Kapit, Kapit,Sarawak, Malaysia

•Klinik Kesihatan Jalan MasjidKuching, Kuching, Sarawak, Malaysia

•Klinik Kesihatan Bandar Miri, Miri,Sarawak, Malaysia

•Klinik Kesihatan Pusa, Pusa,Sarawak, Malaysia

•Klinik Kesihatan Sarikei, Sarikei,Sarawak, Malaysia

•Klinik Kesihatan Siburan, Serian,Sarawak, Malaysia

•Klinik Kesihatan Jalan Oya, Sibu,Sarawak, Malaysia

•Klinik Kesihatan Sri Aman,Simanggang, Sarawak, Malaysia

- of 67 -








23 NCT05105373 Implementation Science and ImpactEvaluation of PfR Programme: AHybrid cRCT Design

Study Documents:

•Study Protocol


•Parenting

•Gender-based Violence

•Child Maltreatment

•IPV

•Behavioral: Parenting forRespectability

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Assessing a Change in Childmaltreatment - physical andemotional abuse; Parent Report

•Assessing a Change in Childmaltreatment - physical andemotional abuse; Child Reporton Male Parent Figure

•Assessing a Change in Childmaltreatment - physical andemotional abuse; Child Reporton Female Parent Figure

•Assessing a Change in Intimatepartner violence - perpetration;Parent-report

•Assessing a Change in Intimatepartner violence -victimisation;Parent-report

•Assessing a Change in Partnerconflict; Child Report

•Assessing a Change in Childphysical abuse-Parent report

•Assessing a Change in Childphysical abuse; Child Report onMale Parent Figure

•Assessing a Change in Childphysical abuse; Child Report onFemale Parent Figure

•Assessing a Change in Childemotional abuse; Parent Report

•and 46 more

Enrollment:

3240

•Makerere University

•University of Glasgow

•Oak Foundation

•Network of EuropeanFoundations

•Wakiso Busukuma and AmuruLamogi subcounties, Kampala,Uganda

- of 67 -







24 NCT05104944 Defining Outcome Measures for AcuteCharcot Neuroarthropathy in Diabetesand Their Use in Assessing ClinicalManagement

Study Documents:

•Study Protocol


•Diabetes •Radiation: Serial MRIs Phase:

Not Applicable

Study Design:





Outcome Measures:

•The proportion of patients whomeet eligibility criteria.

•The number of eligible patientsrecruited.

•The number of participants inwhich an alternative diagnosis ofthe foot disease is made duringthe intervention phase of thetrial.

•The proportion of patients thatwithdraw or are lost to follow up.

•Quality of life and resource datacollection - Sf12.

•Quality of life and resource datacollection - EQ5D.

•Quality of life and resource datacollection - HADS.

•Quality of life and resource datacollection - VAS.

•Quality of life and resource datacollection - patient diary.

•Days with immobilisation

•Progression of foot deformityas documented by measuringradiological foot alignmentangles.

Enrollment:

16

•Norfolk and NorwichUniversity HospitalsNHS Foundation Trust

•University of EastAnglia

•Norfolk & Norwich UniversityHospital, Norwich, Norfolk, UnitedKingdom

- of 67 -








25 NCT05104320 The Quality of Life and Patency RateAfter Minimally Invasive CardiacSurgery

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Minimally InvasiveCardiac Surgery

•Procedure: MICS-CABG

•Procedure: sternotomyCABG

Phase:

Not Applicable

Study Design:





Outcome Measures:

•SF-36 PCS score

•Overall patency rate of the grafts

•SF-36 PCS scores

•SF-36 MCS scores

•Patency rate of the differentmaterial grafts

•Length of incubation

•Hospitalization cost

•Length of postoperativehospitalization time

•Bypass surgical variation index

•Intrahospital RBC transfusionvolume

•and 3 more

Enrollment:

248

•Peking UniversityThird Hospital

26 NCT05103124 GUM Hydral Mouthwash vs Placebo inthe Management of Hyposalivation.

Study Documents:



•Xerostomia

•Xerostomia FollowingRadiotherapy

•Device: Hydral

•Other: Placebo

Phase:

Phase 3

Study Design:





Outcome Measures:

•Improvement of the XerostomiaQuestionnaire (XQ)

•Improvement of the EORTCQLQ-30 questionnaire

•Improvement of the EORTCQLQ_H&N-35 Questionnaire

Enrollment:

40

•Catholic University ofthe Sacred Heart

•Sunstar Italiana SRL.

•Catholic University of the SacredHearth, Roma, Italy

- of 67 -












27 NCT05102760 PENG vs. FIC Block for Hip FractureED Patients

Study Documents:



•Pain

•Hip Fracture

•Procedure: Nerve Blockusing FIC Proceedure

•Procedure: Nerve Blockusing PENG Proceedure

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Pain Score at 30 Minutes

•Pain Score at 60 minutes

Enrollment:

80

•Antonios Likourezos

•Maimonides MedicalCenter

•Maimonides Medical Center,Brooklyn, New York, United States

- of 67 -







28 NCT05102201 Effect of the Group-based ParoIntervention on Physiological andPsychological Outcomes

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Dementia, Mild

•Dementia Moderate

•Cognitive Impairment

•Device: Paro (socialrobot) intervention

Phase:

Not Applicable

Study Design:




•Primary Purpose: HealthServices Research

Outcome Measures:

•Oxytocin

•Finger tapping test (FTT)

•HRV measurements

•The Chinese version of Mini-Mental State Examination(MMSE)

•Core components of executivefunctions- WM and responseinhibition

•Core components of executivefunctions- WM(1) -Verbal WMtask

•Core components of executivefunctions- WM(2)-Visuo-spatialWM task

•Core components of executivefunctions- response inhibition(1)-Color word Stroop task

•Core components of executivefunctions- response inhibition(2)-Stop signal task

•Core components of executivefunctions- response inhibition(3)-Go/no-go task

•and 5 more

Enrollment:

120

•National Tainan JuniorCollege of Nursing

- of 67 -








29 NCT05100849 Kinect-based Versus Tablet-basedCognitive Training: a Pilot Study WithPsychiatric Patients

Study Documents:

•Study Protocol


No ResultsAvailable

•Psychiatric Disorder •Procedure: Kinect-basedcognitive training

•Procedure: Tablet-basedcognitive training

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Montreal Cognitive Assessment(MoCA) (Cognitive screening)

•Frontal Assessment Battery(FAB) (Executive functionsscreening)

•Toulouse-Piéron CancellationTest (TP) (Sustained andselective attention)

•Rey Complex Figure Test(RCFT) (Visuospatial skills andvisual memory)

•Symbol Search and Coding(WAIS-III) (Processing speed)

•Verbal Fluency Tests (semanticand phonemic) (ExecutiveFunctions)

•Free and Cued SelectiveReminding Test (FCSRT)(Verbal Memory)

•Beck Depression InventoryII (BDI-II) (Depressivesymptomatology)

•World Health OrganizationQuality of Life - Bref (WHOQOL-Bref) (Quality of life)

•Adults and Older AdultsFunctional Assessment Inventory(IAFAI)

Enrollment:

18

•Universidade daMadeira

•Casa de SaúdeCâmara Pestana

•Casa de Saúde Câmara Pestana,Funchal, São Gonçalo, Portugal

- of 67 -







30 NCT05099497 Supporting Audit and Feedback toEncourage Vaccine Uptake

Study Documents:



No ResultsAvailable

•Covid19 Vaccination

•Vaccine Uptake

•Other: Using PracticeFacilitators to SupportPhysicians

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Proportion of patients age 12+not yet vaccinated

•Proportion of patients of any agenot yet vaccinated

•Proportion of patients of childrennot yet vaccinated

•Proportion of patients ofadolescents not yet vaccinated

•Number of physicians andpractices engaged by facilitators

•Number of physicians thatlogged into their vaccine report

•Number of practices in whichthe facilitator engaged with amedical assistant to arrangepatient outreach

•Number of physicians thathosted virtual townhalls

•Number of patients that attendedtownhalls

•Number of practices thatengaged medical studentvolunteers unvaccinated patients

•Number of medical studentvolunteers calls made to contactunvaccinated patients

Enrollment:

600

•Women's CollegeHospital

•Ontario Health

•Institute for ClinicalEvaluative Sciences

•Women's College Hospital, Toronto,Ontario, Canada

- of 67 -







31 NCT05099406 Home-based Transcranial Stimulationin the Treatment of Patients WithRefractory Chronic Pain

Study Documents:



•Chronic Pain •Device: Transcranialelectrical stimulation

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Self-reported pain intensity

•Global severity of chronic painsyndrome

•Pressure pain threshold

•Heat pain threshold

•Interference in daily livingcaused by pain

•Life quality

•Physical condition andfunctioning

•Sleep quality and disturbances

•Pain unpleasantness

•Mood disorders

•and 4 more

Enrollment:

120

•University of Santiagode Compostela

•Spanish Ministryof Science andInnovation (Fundingsupport)

•Health ResearchInstitute of Santiagode Compostela - IDIS(Recruitment support)

•Fundación BiomédicaGalicia Sur(Recruitment support)

•University of Santiago deCompostela, Santiago DeCompostela, A Coruña, Spain

32 NCT05098223 Price Promotions on Purchases ofSnacks

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Healthy Diet •Behavioral: Interventionto remove pricepromotions on unhealthyfoods when onlineshopping

Phase:

Not Applicable

Study Design:





Outcome Measures:

•To investigate the effect ofpromotions on the total numberof calories selected

•To investigate the effect ofpromotions on the nutritionalcontent of the items selectedoverall, and across the individualtarget food categories

•To explore the impactof intervention acrosssocioeconomic status

Enrollment:

500

•University of Oxford •Nuffield Dept of Primary Care HealthSciences, Oxford, Oxfordshire,United Kingdom

- of 67 -












33 NCT05097846 Differences in the Eradication ofHelicobacter Pylori by DifferentTherapies

Study Documents:



•Helicobacter PyloriInfection

•Drug: Group1Vonoprazan Fumarate +amoxicillin + doxycycline

•Drug: Group2Vonoprazan Fumarate+ furazolidone +doxycycline

•Drug: Group3esomeprazole + colloidalbismuth tartrate +amoxicillin + doxycycline

•Drug: Group4esomeprazole +colloidal bismuthtartrate + furazolidone +doxycycline

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Eradication rate of Hp at onetime

•Cost-benefit analysis

•Adverse events

Enrollment:

100

•wang xiaoyan

•The Third XiangyaHospital of CentralSouth University

•The third Xiangya Hospital of centralsouth University, Changsha, Hunan,China

34 NCT05096689 Non-operative Treatment of PediatricLateral Humeral Condyle Fractures

Study Documents:

•Study Protocol


•Fracture Humerus

•Physeal Fracture

•Other: MRI Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Mayo Elbow Performance Score(MEPS)

•MRI results

•Radiographic results

•Secondary fracture displacement

•Pain scale (age <5 years)

•Pain scale (age >4 years)

•Pain scale (age >8 years)

Enrollment:

50

•Children's FracturesInterest Group,Denmark

•Copenhagen University Hospital -Herlev and Gentofte, Herlev, CapitalRegion, Denmark

- of 67 -











35 NCT05096676 Understanding Oxytocin's Neural andBehavioral Effects in AdolescentsDiagnosed With Autism

Study Documents:



•Autism SpectrumDisorder

•Oxytocin

•Drug: Oxytocin: Includingplacebo

Phase:

Not Applicable

Study Design:



•Masking: Triple (Participant,Care Provider, Investigator)

•Primary Purpose: Basic Science

Outcome Measures:

•The change in social-relatedneural components (time-lockedneural activity) with and withoutoxytocin

•The change in oscillatory activity- power magnitude of Delta,Theta, Alpha, Beta and Gammaneural bands with and withoutoxytocin

•The change in behavioralmeasurments - reaction timesand accurecy rates, with andwithout oxytocin

Enrollment:

58

•Prof. Ilanit gordon

•Bar-Ilan University,Israel

36 NCT05092997 Kingasa Pilot Study

Study Documents:

•Study Protocol

Enrolling byinvitation

No ResultsAvailable

•HIV

•Linkage to Care

•PMTCT

•PrEP

•ART Adherence

•Diagnostic Test: POCviral load testing

•Other: Wellness visitservices for male partners

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Male partner HIV testing

•Viral suppression

•Male partner linkage

•Acceptability evaluation

Enrollment:

200


•National Institute ofMental Health (NIMH)

•Harvard University

•Infectious Disease Institute, Kampala,Uganda

- of 67 -









37 NCT05091359 Femur Transtrochanteric FracturesTreated With Dynamic Hip Screw andCalcium Sulfate Scaffold.

Study Documents:



•Proximal Femur Fracture •Device: Study groupwith absorbablegraft of tricalcium ßphosphate / calciumsulfate hemihydrate paste

Phase:

Not Applicable

Study Design:





Outcome Measures:

Incidence of cut - out failure ofthe dynamic hip screw implantin unstable transtrochantericfractures

Enrollment:

36

•Hospital RegionalTlalnepantla

38 NCT05091216 The Effects of Traditional ChineseMedicine Mouthwash Solutions on theOral Health of Leprosy Patients

Study Documents:



•Leprosy

•Hansen's Disease

•Xerostomia

•Plaque

•Other: TraditionalChinese Medicinemouthwash

•Other: Dilute 50 timesof Traditional ChineseMedicine mouthwash

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Plaque Index, PLI

•Xerostomia questionnaire

Enrollment:

58

•Lo-Sheng Sanatorium •Lo-Sheng Sanatorium, Taoyuan City,Taiwan

- of 67 -













39 NCT05090683 Evaluation of a Mind-body BasedApplication for the Treatment ofChronic/Persistent Pain.

Study Documents:



•Chronic Pain

•Migraine

•Chronic Pain Syndrome

•Behavioral: Mind-bodymobile application

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change in Brief Pain Inventory-short form (BPI-SF)

•Change in PROMIS PainIntensity short form

•Change in PROMIS PainInterference short form 8a

•Change in Pain CatastrophizingQuestionnaire (PCS)

•Change in DASS-21(Depression, Anxiety, and StressScale)

•Change in Quality of Life ShortForm 12 (SF-12)

•Medication use (daily)

•Medication use (occasional)

Enrollment:

100

•University of theFraser Valley

•University of the Fraser Valley,Chilliwack, British Columbia, Canada

- of 67 -








40 NCT05087043 Effects of Oral Stimulation andSupplemental Nursing System

Study Documents:



•Breastfeeding •Device: Oral motorstimulation (OMS) andThe supplemental nursingsystem (SNS)

Phase:

Not Applicable

Study Design:





Outcome Measures:

•transition times to oral feeding

•transition times to full breast

•the weight of the babies whenthey started oral nutrition

•the weight of the babies whenthey started full breastfeeding

•the duration of the baby'sdischarge

•The oral nutrition body weight

•The full breastfeeding bodyweight

•The discharge body weight

•The sucking success

•Heart rate of the babies

•respiratory rate of the babies

•oxygen saturation of the babies

Enrollment:

70

•Mu#la S#tk# KoçmanUniversity

•Gonca Muslu, Fethiye, Mu#la, Turkey

41 NCT05081297 Qigong and Social Isolation: MentalHealth Benefits

Study Documents:



•Mental Health Wellness 1 •Other: Qigong Phase:

Not Applicable

Study Design:





Outcome Measures:

•Mental health Inventory (MHI)

•Psychological Well-being(Mental health Inventory (MHI)dimension)

•Psychological Distress(Mental health Inventory (MHI)dimension)

Enrollment:

40

•Universidade do Porto •Instituto Português de Taichi eChikung, Maia, Porto, Portugal

- of 67 -











42 NCT05080751 Eating Behaviour and Quality of Lifeof Night Workers in Food and NutritionUnits

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Eating Behavior •Behavioral: EatingBehaviors

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Eating practices

•Eating behavior

•Quality of life and quality of life atwork

Enrollment:

58

•Pontificia UniversidadeCatólica do RioGrande do Sul

43 NCT05080036 Muscle Activation of the LowerLimb in Response to a Medio-lateralImbalance in Monopodal Stance

Study Documents:



•Healthy •Other: Medio-lateralimbalance

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Maximum electrical intensityduring early response of muscleactivation

•Correlation of muscle activity

Enrollment:

5

•Manusapiens •AUSL-IRCCS di Reggio Emilia,Reggio Emilia, Italy

- of 67 -













44 NCT05079958 Effects of Cognitive-behavioralEducation and Exercise Interventionson Smoking Cessation

Study Documents:



•Coronary Artery Disease

•Smoking Cessation

•Behavioral: cognitive-behavioral education

•Behavioral: 12-week briskwalking

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Stage3-The change of smokingcessation success rate

•Stage2-The change of smokingcessation behavior

•Stage3-The change ofFagerstrom Test for NicotineDependence (FTND)

•Stage3-The change of lungcarbon monoxide concentration

•Stage3-The change of heart ratevariability

•Stage3-The change of smokingwithdrawal syndrome

•Stage3-The change of theCenter for EpidemiologicalStudies -Depression Scales(CESD-10)

•Stage3-The change ofTaiwanese Version of the BriefResilience Scale

•Stage2- smoking decision-making

•Stage2- self-efficacy in smokingcessation

Enrollment:

172

•Cathay GeneralHospital

•Cathay General Hospital, Taipei,Taiwan

45 NCT05078463 Efficacy of Transdermal MicroneedlePatch for Topical AnesthesiaEnhancement in PaediatricThalassemia Patients

Study Documents:



•Thalassemia in Children •Device: Microneedle

•Drug: 2 Finger Tip Units(FTUs) EMLA Cream (30-minute application time)

•Drug: 2 Finger Tip Units(FTUs) EMLA (15-minuteapplication time)

•Drug: 1 Finger Tip Unit(FTU) EMLA (30-minuteapplication time)

•Device: Sham Patch

Phase:

Phase 2

Study Design:



•Masking: Double (Participant,Care Provider)


Outcome Measures:

•Visual Analogue Score (VAS)

•Skin Conductance AlgesimeterIndex

Enrollment:

26

•Universiti KebangsaanMalaysia MedicalCentre

•Institue ofMicroengineeringand Nanoelectronics(IMEN), UniversitiKebangsaan Malaysia

•Universiti KebangsaanMalaysia MedicalMolecular BiologyInstitute (UMBI)

•Hospital Canselor Tuanku Muhriz,Universiti Kebangsaan Malaysia(Ukm Medical Centre), KualaLumpur, Wilayah Persekutuan KualaLumpur, Malaysia

- of 67 -














46 NCT05074446 Stereotype Threat Effect On thePerformance of the Non-IntensivistPhysicians Assigned in Covid-19Intensive Care Unit

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Stereotype-threat

•COVID-19

•Other: stereotype threatmanipulation

Phase:

Not Applicable

Study Design:



•Masking: Triple (Participant,Care Provider, Investigator)


Outcome Measures:

Cardiopulmonary Resuscitation(CPR) Performance

Enrollment:

40

•Hacettepe University

47 NCT05073965 Vitamin D Supplementation Effect InChildren With Pulmonary TuberculosisTreatment

Study Documents:



•Tuberculosis, Pulmonary •Dietary Supplement:Vitamin D

•Other: Placebo

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change in Cough Symptom

•Change in Fever Symptom

•Change in Body weight

•Change in Height

•Change in Body Mass Index

•Vitamin D level

•Alanine Transaminase

•Alkaline Phosphatase

Enrollment:

84

•UniversitasPadjadjaran

•RS Bethesda, Bengkayang, WestBorneo, Indonesia

- of 67 -














48 NCT05071248 Evaluation of the Effect of Robot-assisted Early Mobilization - ProjectMobiStaR

Study Documents:

•Study Protocol


•Patient Activation

•Mobilization

•Robotics

•Device: VEMO (ReactiveRobotics GmbH)

Phase:

Not Applicable

Study Design:


•Intervention Model: SequentialAssignment



Outcome Measures:

•Evaluation of the effect of robot-assisted early mobilization oncritically ill patients - Ventilationduration

•Evaluation of the effect of robot-assisted early mobilization oncritically ill patients - sonographicexamination Area of theM.rec.femoris

•Evaluation of the effect of robot-assisted early mobilization oncritically ill patients - sonographicexamination thickness M. quad.femoris

•Evaluation of the effect of robot-assisted early mobilization oncritically ill patients - sonographicexamination- motility diaphragmbreathing

•Evaluation of the effect of robot-assisted early mobilizationon critically ill patients -sonographic examinationthickness diaphragm inspiration

•Evaluation of the effect of robot-assisted early mobilizationon critically ill patients -sonographic examinationthickness diaphragm exhalation

•Evaluation of the effect of robot-assisted early mobilization oncritically ill patients - physicalactivity - FSS-ICU

•Evaluation of the effect of robot-assisted early mobilization oncritically ill patients - physicalactivity

•Behavior and experience ofthe mobilizing professionals -qualitative interviews

•Behavior and experience ofthe mobilizing professionals -qualitative observations

•and 17 more

Enrollment:

60

•Ludwig-Maximilians -University of Munich

•German FederalMinistry of Educationand Research

•Catholic University ofEichstätt-Ingolstadt

•LudwigMaximilians, Munich, BY,Germany

- of 67 -







49 NCT05069142 Peri-Operative Rehab Program forInguinal Hernia Repair Surgery

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Inguinal Hernia •Other: Rehabilitation Phase:

Not Applicable

Study Design:





Outcome Measures:

•Visual Analogue Pain Scale

•Carolinas Comfort Scale (CCS)

•Change in scores on the Short-Form Functional CapacityEvaluation

Enrollment:

30

•University of Alberta •Fort Saskatchewan CommunityHospital, Fort Saskatchewan, Alberta,Canada

- of 67 -







50 NCT05067452 Pilot Trial of the Nutrition-SupportedDiabetes Education Program

Study Documents:



•Diabetes Mellitus, Type 2 •Other: Food support

•Other: Case-management

Phase:

Not Applicable

Study Design:



•Masking: Double (Investigator,Outcomes Assessor)


Outcome Measures:

•Change in Hemoglobin A1c(HbA1c) from baseline to twelveweeks by study arm

•Change in food security severityfrom baseline to twelve weeks bystudy arm

•Change in the proportion ofparticipants with glucose controlfrom baseline to twelve weeks bystudy arm

•Change in the proportion ofparticipants with low and verylow food security from baselineto twelve weeks by study arm

•Change in health-related qualityof life (healthy days) frombaseline to twelve weeks bystudy arm

•Change in consumption of fruitsand vegetables from baseline totwelve weeks by study arm

•Change in consumption of addedsugars from baseline to twelveweeks by study arm

•Change in depressive symptomsfrom baseline to twelve weeks bystudy arm

•Change in diabetes self-efficacyfrom baseline to twelve weeks bystudy arm

Enrollment:

72

•University ofCalifornia, SanFrancisco

•Project Open Hand

•Contra Costa HealthServices

•National Instituteof Diabetes andDigestive and KidneyDiseases (NIDDK)

•Contra Costa Health Services,Martinez, California, United States

- of 67 -







51 NCT05067413 A Study on the Efficacy of a NovelApproach to Achieving LaparoscopicDistal Rectal Transection for RectalCancers

Study Documents:



No ResultsAvailable

•Rectal NeoplasmsMalignant

•Procedure: Transanteriorobturator nerve gatewayapproach

•Procedure: Totalmesorectal excisionapproach

Phase:

Not Applicable

Study Design:



•Masking: Single (Care Provider)


Outcome Measures:

•The degree of Angle

•The degree of #Angle

•Length of distal resection margin

•Rate of conversion to transanaltransection and anastomosis ofthe rectum.

•Rate of anastomotic leakage

•Operative time

•Volume of blood loss

•Anastomotic height from analverge

•Length of stapling line

•Postoperative hospital stay

•and 6 more

Enrollment:

200

•Peking University FirstHospital

•Shengli OilfieldHospital

•The Second AffiliatedHospital of BaotouMedical College

•The Second Affiliated Hospital ofBaotou Medical University, Baotou,Inner Mongolia, China

•Dalian University Affiliated XinhuaHospital, Dalian, Liaoning, China

•Shengli Oilfield Hospital, Dongying,Shandong, China

•The Third People's Hospital ofDatong, Datong, Shanxi, China

- of 67 -









52 NCT05065281 Responding to Elder Abuse inGERiAtric Care: EducationalIntervention

Study Documents:



No ResultsAvailable

•Healthy •Other: Education Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change between baseline andfollow up concerning askingquestions about abuse, asreported in the questionnaireREAGERA-P

•Change between baseline andfollow up concerning adequatefollow up, as reported in thequestionnaire REAGERA-P

•Change between baselineand follow up concerning self-reported hesitancy for askingquestions about elder abuse,as reported in the questionnaireREAGERA-P

•Degree of changed practice asreported in the questionnaireREAGERA-P

•Change between baselineand follow up concerning self-efficacy, as reported in thequestionnaire REAGERA-P

•Change between baseline andfollow up concerning perceivedindividual level barriers (1), asreported in the questionnaireREAGERA-P

•Change between baseline andfollow up concerning perceivedindividual level barriers (2), asreported in the questionnaireREAGERA-P

•Change between baseline andfollow up concerning perceivedorganizational level barriers, asreported in the questionnaireREAGERA-P

•Change between baseline andfollow up concerning sense ofresponsibility, as reported in thequestionnaire REAGERA-P

•Change between baseline andfollow up concerning level ofawareness of abuse in contactwith patients, as reported in thequestionnaire REAGERA-P

Enrollment:

750

•Region Östergötland

•Linkoeping University

•Region JönköpingCounty

•Linnaeus University

•Region Jönköpings län, Eksjö,Sweden

•Region Jönköpings Län, Jönköping,Sweden

•Region Östergötland, Linköping,Sweden

•Region Östergötland, Norrköping,Sweden

- of 67 -








53 NCT05065268 Visual Rehabilitation in Children WithHomonymous Hemianopia: a PilotStudy on Virtual-reality Stimulation

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Hemianopia

•Brain Tumor

•Children, Only

•Device: ImmersiveVirtual-Reality Stimulation

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Feasibility

•Change in Visual acuity

•Change in Reading speed

•Change in Field of vision

•Change in Quality of life

Enrollment:

10

•The Hospital for SickChildren

•University HealthNetwork, Toronto

•The Hospital for Sick Children,Toronto, Ontario, Canada

•University Health Network, Toronto,Ontario, Canada

- of 67 -








54 NCT05058911 Exposure-based Cognitive BehaviorTherapy vs Traditional CognitiveBehavior Therapy for Fibromyalgia

Study Documents:



•Fibromyalgia •Behavioral: Internet-delivered exposure-based cognitive behaviortherapy

•Behavioral: Internet-delivered traditionalcognitive behaviortherapy

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change in FM severity over themain phase, as modelled usingdata from all 11 assessmentsfrom the pre-treatmentassessment, weekly to theprimary endpoint (10 weeks).

•Change in pain over the mainphase, as modelled using datafrom all 11 assessments fromthe pre-treatment assessment,weekly to the primary endpoint(10 weeks).

•Change in fatigue over themain phase, as modelled usingdata from the pre-treatmentassessment and primaryendpoint (10 weeks)

•Change in anxiety over themain phase, as modelled usingdata from the pre-treatmentassessment and primaryendpoint (10 weeks)

•Change in depression over themain phase, as modelled usingdata from the pre-treatmentassessment and primaryendpoint (10 weeks)

•Change in functional impairmentover the main phase, asmodelled using data from thepre-treatment assessment andprimary endpoint (10 weeks).

•Change in quality of life over themain phase, as modelled usingdata from the pre-treatmentassessment and primaryendpoint (10 weeks).

•Global impression of perceivedchange at post-treatment

Enrollment:

260

•Karolinska Institutet

•Uppsala University

•Karolinska Institutet, Solna, Sweden

•Uppsala University, Uppsala, Sweden

- of 67 -








55 NCT05057598 DianaWeb: Before and After StudyOnline Based Participatory Researchon Breast Cancer Women

Study Documents:



•Breast Cancer •Other: Community-basedparticipatory research ondiet and lifestyle

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Increase rate of survival

•Decrease incidence of relapses

•Decrease incidence ofmetastasis

•Decrease incidence of MetabolicSyndrome parameters

•Decrease blood level on C-reactive protein (chronicinflammation marker)

•Decrease the insulin resistanceindex (HOMA index)

•Increase in the score ofadherence to the Mediterraneandiet score (MDS)

•Increase in the score ofadherence to the ItalianMediterranean index (IMI)

•Increase in the score ofadherence to the MediterraneanAdequancy index (MAI)

•Increase in the score ofadherence to the AICR/WCRFrecommendations to the 2018WCRF/AICR News Score

•Increase in the score to the"European Organisation forResearch and Treatmentof Cancer, Quality of Lifequestionnaire-core 30 (Version3.0)" after breast cancerdiagnosis

•Increase in the score to the"European Organisation forResearch and Treatmentof Cancer, Quality of Lifequestionnaire-breast cancer 45(QLQ-BR45)" during therapy

Enrollment:

50000

•Fondazione IRCCSIstituto Nazionale deiTumori, Milano

•University Of Perugia

•Azienda OspedalieraUniversitariaPoliclinico PaoloGiaccone Palermo

•Azienda SocioSanitaria Territoriale diMantova

•Presidio OspedalieroUnico "Santa Mariadella Misericordia",Urbino

•Ospedale Città diCastello- Perugia

•University of Urbino"Carlo Bo"

•Fondazione Vita eSalute

•Fondazione Irccs Istituto NazionaleDei Tumori, Milano, MI, Italy

- of 67 -








56 NCT05057156 Digital Solution to Improve CognitiveFunction in Epilepsy: PRODDIGEProject

Study Documents:

•Study Protocol

Not yetrecruiting

No ResultsAvailable

•Cognitive Change •Behavioral: cognitiverehabilitation

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Number of weekly connections ofepileptic patients in each group.

•Feeling the frequency of lexicalaccess problems

•Self-esteem assessment

•Mood assessment

•Anxiety assessment

•Information processing speed

•Lexicon access assessment

• lexicon access assessment intime

•Selective and sustained attentionassessment

•Working memory assessment

•and 5 more

Enrollment:

90

•Central Hospital,Nancy, France

•UCB Pharma

- of 67 -







57 NCT05054179 Pecto-Intercostal Fascial Plane BlockCatheter Trial for Reduction of SternalPain

Study Documents:

•Study Protocol

Not yetrecruiting

No ResultsAvailable

•Cardiac Surgery

•Sternotomy

•Acute Pain

•Drug: Ropivacaine 0.2%Injectable Solution

•Other: Saline

Phase:

•Phase 2

•Phase 3

Study Design:



•Masking: Triple (Participant,Care Provider, OutcomesAssessor)


Outcome Measures:

•Numeric rating scale (NRS)sternal pain score on coughing at24 hours.

•Numeric rating scale (NRS)sternal pain score on coughing

•Cumulative opioid consumption(in IV morphine equivalents)

•Nausea or vomiting

•Quality of Recovery-15 score(QoR-15)

•Chronic sternal pain

•Quality of Life as measuredby European Quality of Life-5Dimension-5 Level (EQ-5D-5L)

Enrollment:

80

•University of BritishColumbia

•St. Paul's Hospital, Vancouver, BritishColumbia, Canada

- of 67 -







58 NCT05052151 Temperature and Bicarbonate:Hemodynamic Effects During Dialysis

Study Documents:

•Study Protocol


•End Stage Renal Diseaseon Dialysis

•Other: Low dialysatetemperature

•Other: High dialysatetemperature

•Other: Low dialysatebicarbonate concentration

•Other: High dialysatebicarbonate concentration

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Blood pressure (BP)

•Intradialytic cardiac output

•Intradialytic total peripheralresistance

•Intradialytic stroke volume

•Intradialytic heart rate

•Intradialytic central blood volume

•Intradialytic mean arterial bloodpressure

•Plasma calcium

•Plasma potassium

•Plasma magnesium

•Intradialytic hypotension (IDH)

•Ortostatic hypotension (OH)

Enrollment:

16

•University of Aarhus •Dialysis Clinic at Department ofRenal Medicine, Aarhus UniversityHospital and affiliated dialysis clinicsin Randers and Horsens, Aarhus,Region Midt, Denmark

59 NCT05051982 Sedline EEG Guided Depth ofAnesthesia

Study Documents:



•Anesthesia

•Surgery

•Other: Sedline EEG inView

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Total Average Anesthetic

•Total Hypnotic agents

•episodes of hypotension

•total dosage of vasopressors

•occurrence of EEG isoelctricity

Enrollment:

110

•Indiana University •IU Health University Hospital,Indianapolis, Indiana, United States

- of 67 -










60 NCT05051826 Effect of Resistance Training in WaterCombined With Land on Startingand Turning ,12-weeks ResistanceTraining

Study Documents:

•Study Protocol


•Resistance, APC •Other: Resistancetraining that combineswater and land

Phase:

Not Applicable

Study Design:





Outcome Measures:

starting and turning performanceof Chinese adolescent swimmer

Enrollment:

80


•Guo wei, Guyuan, Ningxia, China

61 NCT05050539 Adaptive Implementation to OptimizeDelivery of Obesity PreventionPractices in Early Care and EducationSettings

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Obesity, Childhood

•Nutrition Aspect ofCancer

•Behavioral: Low Intensity

•Behavioral: High Intensity

Phase:

Not Applicable

Study Design:





Outcome Measures:

Fidelity to WISE Evidence-BasedPractices using the WISE fidelityobservational measure

Enrollment:

1850

•University of Arkansas

•Louisiana TechUniversity

•University of Arkansas for MedicalSciences, Little Rock, Arkansas,United States

- of 67 -














62 NCT05050201 Implementation of Digital CBT forInsomnia in First Episode Psychosis

Study Documents:

•Study Protocol


•Insomnia

•Psychosis

•First Episode Psychosis

•Device: Sleepio Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Implementation data - rates ofconsenting

•Implementation data - eligibility

•Implementation data -completion of measures

•Implementation data -completion of interventionsessions

•Qualitative data

•Insomnia severity

•Mental Wellbeing

•Paranoia symptomatology

•Hallucination symptomatology

•Anxiety regarding Covid19

Enrollment:

22

•NHS Greater Glasgowand Clyde

•University of Glasgow

•Big Health

•Esteem North, NHS Greater Glasgowand Clyde, Glasgow, United Kingdom

•Esteem South and Clyde, NHSGreater Glasgow and Clyde,Glasgow, United Kingdom

63 NCT05049915 Evaluation of the Clinical Effectivenessof Bioactive Glass (S53P4) in theTreatment of Tibia and Femur Non-unions

Study Documents:

•Study Protocol


•Pseudoarthrosis of Bone •Device: bioglass (S53P4)

•Device: RIA and TCP

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Rate of participants with osseusconsolidation evaluation via x-ray

•12-item Short Form Survey(SF-12)

•Perfusion

•Rate of participants with osseusconsolidation evaluation via CT

Enrollment:

50

•Sebastian Findeisen

•Bonalive BiomaterialsLtd

•University HospitalHeidelberg

•University Hospital Heidelberg,Heidelberg, Baden-Württemberg,Germany

- of 67 -











64 NCT05048043 Development of a Game-supportedIntervention

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Attention DeficitHyperactivity Disorder

•Behavioral: Computer-assisted BehaviorIntervention

•Behavioral: ChallengingHorizons Program

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change from baseline on theClassroom Performance Survey(CPS)

•Change from baseline on theSchool Functioning Scale (SFS)

•Change from baseline on theChildren's Organizational SkillsScale--Parent Report (COSS-P)

•Change from baseline on theWorking Alliance Inventory -Short Revised (WAI-SR)

•Group comparison of SchoolGrades

•Group comparison ofSatisfaction Questionnaire data

•Descriptive single-group analysisof Technology AcceptanceModel Instrument - Fast Form

Enrollment:

36

•East CarolinaUniversity

•Ohio University

65 NCT05047900 The Impact of SARS-CoV-2 RapidAntigen Testing Kit Screening inBangkok Community

Study Documents:


Not yetrecruiting

No ResultsAvailable

•Covid19

•SARS-CoV-2

•CommunityTransmissions

•Coronavirus Infections

•Diagnostic Test: Rapidantigen testing kit

Phase:

Not Applicable

Study Design:




•Primary Purpose: Screening

Outcome Measures:

•Incidence rate of COVID19infection

•Incidence rate of severeCOVID19 infection

•Incidence of COVID19 infectionin COVID19 vaccinated and nonvaccinated people

•sensitivity and specificity of rapidantigen testing kit

Enrollment:

70000

•Mahidol University

•Yuvabadhanafoundation

•Zero COVID Thailand

•ChulalongkornUniversity

•Ministry of Health,Thailand

- of 67 -












66 NCT05046210 The Effectiveness of Lay HealthAdvisors Strategy Interventionon Aborigines Elderly Oral CareEducation

Study Documents:



•Oral Health •Behavioral: LHAintervention

•Behavioral: Oral exerciseintervention

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Oral health-related quality of life

•Swallowing

•syllable /pa/, /ta/ and /ka/

•Masticatory performance

•Saliva flow rate

•Perceived dysphagia

•Plaque control record (PCR)

•Plaque index (PI)

•Winkel tongue coating index(WTCI)

•Regular dental visit

•and 3 more

Enrollment:

240

•Kaohsiung MedicalUniversity Chung-HoMemorial Hospital

•Kaohsiung Medical University,Kaohsiung city, Taiwan

- of 67 -









67 NCT05045131 PeAF-BOX: Feasibility, Safety andEfficacy of PVI + Box Ablation inPersistent Atrial Fibrillation

Study Documents:



•Atrial Fibrillation •Procedure: Left atrialcombined pulmonary veinisolation and posteriorwall isolation

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•The safety of single procedurePVI + PWI

•Feasibility of a first-procedurePVI + PWI strategy

•Temperature in the esophagusduring radiofrequency ablation

•Durability of the PVI + PWI lesionset

•AF recurrence short term

•AF burden short term

•AF recurrence long term

•AF burden long term

•Long term efficacy PVI + PWI

•Effect on quality of life by PVI +PWI

Enrollment:

24

•René Husted Worck

•Biosense Webster,Inc.

•University Hospital,Gentofte, Copenhagen

68 NCT05043909 The Effects of Virtual Reality andAugmented Reality Training Systemon Elderly Oral Care Skill for OralHygiene and Nursing Students

Study Documents:



•Medical Education •Behavioral: VR-basedtraining

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Elderly oral care-relatedknowledge

•Attitude toward elderly oral care

•Self-efficacy of elderly oral care

•Intention to elderly oral carebehaviors

Enrollment:

23

•Kaohsiung MedicalUniversity Chung-HoMemorial Hospital

•Kaohsiung Medical University,Kaohsiung, San Min District, Taiwan

- of 67 -














69 NCT05040620 Effectiveness of Olive Oil LocalApplication in Orthodontic Patients.

Study Documents:



•Orthodontic ToothMovement

•Drug: Olive Oil Topical Oil Phase:

Phase 1

Study Design:





Outcome Measures:

•The duration of orthodontic teethaligning using Little irregualrityindex

•orthodontic wire surfaceroughness changes

Enrollment:

110

•Minia University •Ahmed Nasef, Minya, Egypt

70 NCT05040074 SQ-Kyrin TMVr FIM Study

Study Documents:

•Study Protocol


•Mitral Regurgitation •Device: SQ-KyrinTranscatheter Edge-to-Edge Valve RepairSystem

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Incidence of acute proceduralsuccess

•All-cause mortality

•Incidence of serious adverseevent(SAE)

•Device success rate

•Procedural success rate

Enrollment:

20

•Shanghai ShenqiMedical TechnologyCo., Ltd

•General Hospital of Northern TheaterCommand, PLA, Shenyang, Liaoning,China

- of 67 -









71 NCT05039190 A Study to Evaluate Thefficacyand Safety of HBM9161 (HL161)Subcutaneous Injection in PatientsWith Generalized MG Patients

Study Documents:

•Study Protocol

Not yetrecruiting

No ResultsAvailable

•Myasthenia Gravis •Drug: HBM9161 Injection(680mg)

•Drug: Placebos

Phase:

Phase 3

Study Design:





Outcome Measures:

•Percentage of patients withsustained improvement (AChR-Ab-positive or MuSK-Ab-positivepatient population) duringthe first treatment period andobservation period

•Percentage of patients withsustained improvement (i.e.Entire Population) during the firsttreatment period and observationperiod

•Percentage of patients withsustained improvement (AChR-Ab-positive or MuSK-Ab-positivepatient populations) during thesecond treatment period andobservation period

Enrollment:

144

•Harbour BioMed(Guangzhou) Co. Ltd.

•Huashan Hospital, Fudan University,Shanghai, Shanghai, China

- of 67 -








72 NCT05038579 Clinical Validation of a CognitiveStimulation Platform for IndividualsWith Dementia - Musiquence

Study Documents:

•Study Protocol


•Dementia •Procedure: Musiquence Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Mini-Mental State Examination(Cognitive Screening) (MMSE)

•Alzheimer's Disease AssessmentScale - Cognitive Scale (ADAS -Cog)

•Quality of Life - Alzheimer'sDisease (QoL - AD)

•Kettler Laurent Thierreau (KLT)

•Symbol Search - Weschler AdultInteligence Scale 3rd edition(SR)

•Digital Symbol Coding -Weschler Adult Inteligence Scale3rd edition (DSC)

•Semantic and Phonemic VerbalFluency (SPVF)

•Adults and Older AdultsFunctional Assessment Inventory(IAFAI)

•Cornell Scale for Depression inDementia

•Rating Anxiety in Dementia(RAID) scale.

Enrollment:

13

•Universidade daMadeira

•Instituto São João deDeus

•Casa de SaúdeCâmara Pestana

•Centro Social eParoquial da RibeiraBrava

•Associação deDesenvolvimentoComunitário doFunchal, Centrode Dia Lugar deMemórias

•Universidade da Madeira, Funchal,Autonomous Region Of Madeira,Portugal

- of 67 -







73 NCT05037617 The REDUCED-I Pilot Trial: REDucingthe Utilization of CEsarean SectionsWith Induction

Study Documents:



•Induced; Birth •Drug: Continuationor discontinuation ofoxytocin during the activefirst stage of labor (#6 cmdilation).

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Rate of Cesarean section inlabor

•Occurrence of UterineHyperstimulation

•Proportion of screened subjectswho agree to enroll in the trial

•Rate of perinatal death

•Rate of neonatal asphyxia

•Rate of moderate or severeasphyxia (Sarnat) or meetscriteria for therapeutic cooling

•Rate of neonatal sepsis orsuspected sepsis

•Rate of postpartum hemorrhage

•Rate of blood transfusion

•Rate of postpartum uterineartery/pelvic artery embolization

•Rate of postpartum hysterectomy

•Rate of postpartum maternalintensive care unit (ICU)admission

Enrollment:

200

•University of Calgary •University of Calgary, Calgary,Alberta, Canada

- of 67 -








74 NCT05037591 Effect of Sea Grapes-antioxidantsExtract in Obese Men : 4 WeeksRandomized-Double Blind ControlledTrial

Study Documents:



•Obesity

•Aging

•Diabetes

•Drug: Sea grapes extract1.68 g/70kg BW

•Drug: Placebo

Phase:

Early Phase 1

Study Design:



•Masking: Double (Participant,Care Provider)


Outcome Measures:

•Peroxisome proliferator-activatedreceptor (PPAR)-# coactivator 1alpha (PGC-1#) Levels "change"is being assessed

•Total Cholesterol "change" isbeing assessed

•Blood Glucose "change" is beingassessed

•Body Mass Index (BMI)

•Triglycerides

•high-density lipoprotein (HDL)

• low-density lipoprotein (LDL)

•Body Weight

•Body Height

•waist-to-hip ratio (WHR)

Enrollment:

70

•State IslamicUniversity of SunanKalijaga Yogyakarta

•Fahrul Nurkolis, Manado, SulawesiUtara, Indonesia

- of 67 -









75 NCT05035277 AntiCoagulation Versus AcetylSalicylicAcid After Transcatheter Aortic ValveImplantation

Study Documents:

•Study Protocol

Not yetrecruiting

No ResultsAvailable

•Aortic Stenosis •Drug: Acetylsalicylic acid

•Drug: Apixaban

•Drug: Rivaroxaban

•Drug: Edoxaban

Phase:

Phase 3

Study Design:





Outcome Measures:

•Hypo-attenuated leafletthickening

•Safety composite - Incidence ofTreatment Emergent AdverseClinical Outcome

•Major adverse cardiovascularevents (MACE)

•Clinical efficacy

•Safety composite, superiority

•Thromboembolic events

•Bleeding events

•All-cause mortality

•The number of adverse events

•The number of serious adverseevents

•and 3 more

Enrollment:

360

•Oslo UniversityHospital

•University of Oslo

76 NCT05033977 Center-based Physical Therapy andHome-based Physical Therapy AfterPlatelet Rich Plasm Injection

Study Documents:



•Knee Osteoarthritis •Other: Exercise (center-based)

•Other: Exercise (home-based)

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Visuel analogue scale

•Muscle Strenght

•Physical Function

•Knee Function

•Weight

•Height

•Body mass index (BMI)

Enrollment:

30

•Hacettepe University •Hacettepe University, Ankara,Samanpazari, Turkey

- of 67 -












77 NCT05033600 Pulsed ElectroMagnetic Field (PEMF)Therapy in Treating Post-TraumaticStress Disorder (PTSD) & Trauma

Study Documents:



•Unspecified Trauma-and Stressor-RelatedDisorder

•Device: S.C.I.O. Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Anxiety

•Hyper-Sensitivity

•Insomnia

•Self-Sabotage

•Reliance upon copingmechanisms such as drugs oralcohol

•Re-imagining or 3D flash backs

•Sudden outbursts of anger,mood swings, irritability

Enrollment:

5

•Kasey Phifer

•The National Centrefor ElectroMagneticTherapies CIC

•The National Centre forElectroMagnetic Therapies CIC -Private Clinic at Hillside Studios,Berwick Lane, Easter Compton,Bristol, United Kingdom

78 NCT05032456 Immersive Virtual Reality Satisfies theWomen in Labor by Distracting ThemFrom Their Labor Pain in Labor onLatent and Active Phase

Study Documents:

•Study Protocol


•Labor Pain •Device: Oculus QuestAll-in-one VR GamingHeadset (128 GB) VRsystem

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Virtual Reality SatisfactionSurvey

•Wong-Baker Faces Pain

•Visual Analog Scale (VAS)

•Beck Anxiety Inventory (BAI)

•Beck Depression Inventory (BDI)

Enrollment:

42

•Bahçe#ehir University

•Acibadem MaslakHospital

•Acibadem Maslak Hospital, Istanbul,Sariyer, Turkey

- of 67 -













79 NCT05029739 An E-health Intervention for PatientsWith Peripheral Artery Disease

Study Documents:



•Intermittent Claudication •Device: A PAD-specificsmartphone application(e-intervention)developed for patientswith Peripheral ArteryDisease

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Six-minute walk test.

•Smoking status

•Increased readiness to quitsmoking.

•Medication adherenceimprovement

•Disease-specific health-relatedquality of life.

•Comparing outcomes to healthliteracy

•Quality Adjusted Life Years(QALYs)

•Change in self-assessed stresslevels

•Change in self-assessed sleepquality levels

•Change in self-assessed energylevels

•Change in free living physicalactivity

Enrollment:

155

•SahlgrenskaUniversity Hospital,Sweden

•Karolinska UniversityHospital

•Skane UniversityHospital

•Karlstad CentralHospital

•Jonkoping CountyHospital

•Sidekick Health

•Sahlgrenska University Hospital,Gothenburg, Sweden

•Jönköping Central Hospital,Jönköping, Sweden

•Karlstad Central Hospital, Karlstad,Sweden

•Skane University Hospital, Malmö,Sweden

•Karolinska University Hospital,Stockholm, Sweden

- of 67 -







80 NCT05028361 Simultaneous mRNA COVID-19 andIIV4 Vaccination Study

Study Documents:

•Study Protocol


•Pain

•Quality of Life

•Injection Site Reaction

•Adverse Drug Event

•Biological: mRNACOVID-19

•Biological: IIV4

•Other: Placebo

Phase:

Phase 4

Study Design:



•Masking: Triple (Participant,Care Provider, OutcomesAssessor)


Outcome Measures:

•Number of participants withmoderate or more severe fever,chills, myalgia, or arthralgia inthe Simultaneous Group and theSequential Group following bothVaccination Visit 1 and 2

•Number of participants withmoderate or more severe fever,chills, myalgia, or arthralgia inthe Simultaneous versus theSequential Group following thefirst vaccination visit

•Number of participants withmoderate or more severe fever,chills, myalgia, or arthralgiain the Simultaneous versusSequential Group following thesecond vaccination visit

•Number of participants in theSimultaneous and Sequentialvaccination groups with solicitedlocal and systemic reactogenicityevents according to severitygrade after the first, second andthird vaccination visit

•Observed serious adverseevents in both treatment groups

Enrollment:

450

•Duke University

•Centers for DiseaseControl andPrevention

•Johns HopkinsUniversity

•Children's HospitalMedical Center,Cincinnati

•John Hopkins University, Baltimore,Maryland, United States

•Duke University, Durham, NorthCarolina, United States

•Cincinnati Children's Hospital MedicalCenter, Cincinnati, Ohio, UnitedStates

- of 67 -






81 NCT05026216 To Assess the Effectiveness ofMultiple Dose, Multiple Concentrationsof Qwo, for the Treatment of Mild toModerate Cellulite.

Study Documents:

•Study Protocol


•Cellulite •Drug: Qwo Phase:

Phase 4

Study Design:

•Allocation: N/A




Outcome Measures:

•Improved score iGAIS

•BODY-Q- APPRAISAL OFCELLULITE Copyright©2019Memorial Sloan-KetteringCancer Center, New York, USA.All rights reserved.

•Dilution Matrix

Enrollment:

5

•DMR Research, PLLC

•Endo Pharmaceuticals

•DMR Research, PLLC, Westport,Connecticut, United States

82 NCT05024071 Effect of Core Strength Trainingon Wushu C-level DifficultyMovements ,12 Weeks of CoreStrength Training

Study Documents:

•Study Protocol


•Experimental Myasthenia •Device: Wushu athletesin the experimental groupused a Swiss ball for 12weeks of core strengthtraining

•Device: Wushu athletesin the experimental groupused a balance board for12 weeks of core strengthtraining

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Basic stage of core strengthtraining (s)

•Core strength trainingconsolidation stage (s)

•Core strength trainingimprovement stage (s)

Enrollment:

40


•Ningxia sports vocational andTechnical College, Yinchuan,Ningxia, China

- of 67 -













83 NCT05023902 Comparison of NeuromuscularIntegrative Activity and Pilates onSedentary Females

Study Documents:



•Womens's Health

•Healthy

•Sedentary Behavior

•Other: Pilates

•Other: NeuromuscularIntegrative Action

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Rosenberg Self Esteem Scale

•Short Form Health Survey

•Beck Anxiety Inventory

•Visual Analog Scale and FatiqueEvaluation

•The Sit and Reach Test

•6 Minute Walk Test

•Sit - Up Test

•Functional Reach Tests

Enrollment:

43

•Alanya AlaaddinKeykubat University

•Alanyaaku, Antalya, Alanya, Turkey

84 NCT05019989 Trial of Diet, Physical Activity andBreast Cancer Recurrences: theDIANA-5 Study

Study Documents:



•Breast Cancer Invasive •Behavioral: Interventiongroup on diet andphysical activity

•Behavioral: Controlgroup: only publicrecommendation anlifestyle

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Reduction of recurrences

•Modification lifestyle andMetabolic Syndrome (MetS)

•Modification lifestyle and BodyMass Index (BMI)

•Modification lifestyle andTestosterone

•Modification lifestyle and Insulin

•Development other cancer

•Development diabetes

•Total mortality

Enrollment:

1542

•Fondazione IRCCSIstituto Nazionale deiTumori, Milano

•Associazione Italianaper la Ricerca sulCancro

•European Institute ofOncology

•Centro di Riferimentoper l'Epidemiologia ela Prev. OncologicaPiemonte

•Federico II University

•IRCCS CancerReferral Center ofBasilicata

•ARNAS Civico DiCristina BenfratelliHospital

•Lega Italiana per laLotta contro i Tumori

•Azienda SocioSanitaria Territoriale diMantova

•Ministero della Salute,Italy

- of 67 -












85 NCT05019404 Minimally Invasive Surgical EpilepsyTrial for Temporal Lobe Epilepsy

Study Documents:



•Temporal Lobe Epilepsy

•Open Surgery

•Minimally InvasiveSurgery

•Procedure: Functionalanterior temporallobectomy (FATL)

•Procedure: Anteriortemporal lobectomy (ATL)

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Surgery duration

•Blood loss

•Skin incision

•Bone flap

•Postoperative hospital stay

•Complications

•Seizure outcomes classified bythe International League AgainstEpilepsy (ILAE)

•Seizure outcomes classified bythe Engel

•Quality of life assessed bythe Quality of Life in EpilepsyInventory- 89

Enrollment:

120

•First Affiliated HospitalXi'an JiaotongUniversity

•First Affiliated Hospital of Xi'anJiaotong University, Xi'an, Shaanxi,China

86 NCT05016154 Online Psychological GroupInterventions

Study Documents:



•Depression

•Anxiety

•Behavioral: Online GroupCBT intervention

•Behavioral: SilverCloudguided

•Behavioral: SilverCloudUnguided

•Behavioral: Mood Flow

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Change from baseline scoresin the mean symptoms ofdepression as measured by thePHQ-9 at 3-months.

•Change from baseline scores inthe mean symptoms of anxietyas measured by the GAD-7 at 3-months.

Enrollment:

400

•University ofStellenbosch

•Harvard University

•West VirginiaUniversity

•Stellenbosch University, Cape Town,Western Cape, South Africa

- of 67 -











87 NCT05016076 Multi-Strategy Intervention forAnesthesia Care of Obese Patients AFactorial Randomized Controlled Trial

Study Documents:



•Obesity

•Bariatric SurgeryCandidate

•Tracheal IntubationMorbidity

•Nausea and Vomiting,Postoperative

•Hyperglycemia DrugInduced

•Gastric Reflux

•Drug: Dexamethasone 8mg

•Diagnostic Test: Appliedinspiratory pressure (10,15, 20, or 25 cmH2O)

•Device: Trachealintubation using videointubating stylet, videolaryngoscopy, or directlaryngoscopy

•Device: Goal-directedhemodynamic therapytargeting cardiac index

•Drug: Placebo (0.9%sodium chloride)

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Substudy 1: Number ofparticipants developingpostoperative nausea andvomiting

•Substudy 2: The thresholdinspiratory pressure for gastricinsufflation

•Substudy 3: The best glottisvisualization, graded accordingto Cormack and Lehane'sclassification

•Substudy 4: Number ofparticipants developingpostoperative majorcomplications

Enrollment:

180

•YingHsuanTai

•Taipei MedicalUniversity Shuang HoHospital

•Shuang Ho Hospital, Taipei MedicalUniversity, New Taipei City, Taiwan

88 NCT05013294 Using mHealth (Mobile Health) toOptimize Glycemic Control in AdultsWith Type 2 Diabetes: Proof ofConcept Study

Study Documents:

•Study Protocol

Not yetrecruiting

No ResultsAvailable

•Diabetes •Other: Intervention Phase:

Not Applicable

Study Design:





Outcome Measures:

•Glycated hemoglobin

•Fasting Plasma Glucose (FPG)

•Total cholesterol (TC)

•Triglycerides (TG),

•High-density lipoprotein-cholesterol (HDL-C)

•mHealth (mobile health)Satisfaction

•Weight

•Height

•Waist-hip ratio

Enrollment:

60

•KU Leuven

•Jomo KenyattaUniversity ofAgriculture andTechnology

- of 67 -













89 NCT05012072 Reducing Pregnancy Risks: TheMastery Lifestyle Intervention

Study Documents:



•Mental Health Wellness 1

•Preterm Birth

•Behavioral: The MasteryLifestyle Intervention

Phase:

Not Applicable

Study Design:



•Masking: Triple (Care Provider,Investigator, OutcomesAssessor)


Outcome Measures:

•Anxiety

•Depression

•Stress

•Coping levels

•To explore the effect of the MLI,versus a usual care group, onthe neuroendocrine risk factorof preterm birth (CorticotropinReleasing Hormone (CRH).frombaseline to end-of treatment.

•To explore the effect of the MLI,versus a usual care group, onneuroendocrine risk factors(progesterone) on pretermbirth from baseline to end-oftreatment.

•To explore the effect of the MLI,versus a usual care group, onthe neuroendocrine risk factor ofEstriol.

Enrollment:

234

•Microgen LLC •Anthony Chavez, MD, Houston,Texas, United States

90 NCT05011500 Masks Against Surface-Scanning forRadiation Therapy Immobilisation inHead and Neck Cancer (MASSC)

Study Documents:



•Head and NeckNeoplasm

•Radiation: Radiotherapywith Closed Mask

•Radiation: Radiotherapywith Open Mask andSurface Scanning

•Radiation: Radiotherapywith No Mask

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Positional Deviation

•Patient Distress

•Duration of Treatment

•Radiotherapy TechnicianSatisfaction

•Radiation Dose

Enrollment:

24

•Cancer ResearchAntwerp

•GZA Ziekenhuizen campus Sint-Augustinus, Antwerp, Belgium

- of 67 -












91 NCT05010824 A Brief Parent-based SleepIntervention for Children With AutismSpectrum Disorder

Study Documents:

•Study Protocol


No ResultsAvailable

•ASD

•Insomnia

•Behavioral: Sleephygiene practices andbehavioural intervention

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Child: Change of child's sleep

•Child: change of insomniasymptoms (bedtime resistance)

•Child: change of insomniasymptoms (sleep onset delay)

•Child: change of insomniasymptoms (night waking)

•Parent: Change of parental self-reported sleep quality

•Parent: Change of parentalinsomnia symptoms

•Child: Change of child'sbehaviour & other clinicalsymptoms

•Child: Change of child'sexecutive functions reported byparents

•Parent: Change of parentalmood symptoms

•Parent: Change of parentalstress

•and 3 more

Enrollment:

60

•The University of HongKong

•Department of Clinical Psychology,The Duchess of Kent Children'sHospital at Sandy Bay, HKWC,Hospital Authority, Hong Kong, HongKong

•Sleep Research Clinic & Laboratory,Department of Psychology, TheUniversity of Hong Kong, Hong Kong,Hong Kong

- of 67 -







92 NCT05009251 Using Explainable AI Risk Predictionsto Nudge Influenza Vaccine Uptake

Study Documents:



No ResultsAvailable

•Influenza

•Vaccination

•Health Promotion

•Health Behavior

•Risk Reduction

•Behavioral: Reminder

•Behavioral: Riskreduction

•Behavioral: Medicalrecords-basedrecommendation

•Behavioral: Algorithm-based recommendation

Phase:

Not Applicable

Study Design:



•Masking: Single (Care Provider)


Outcome Measures:

•Flu vaccination at 2 weeks afterfinal outreach date

•Flu vaccination at 9 weeks afterfinal outreach date

•Flu diagnosis

•Flu complications

•Healthcare utilization

Enrollment:

45164

•National Bureau ofEconomic Research,Inc.

•Geisinger Clinic

•MassachusettsInstitute of Technology

•National Institute onAging (NIA)

•Geisinger Clinic, Danville,Pennsylvania, United States

93 NCT05008809 Post-resection/Ablation Chemotherapyin Patients With Metastatic ColorectalCancer (FIRE-9 - PORT / AIO-KRK-0418)

Study Documents:



•Colorectal Cancer •Drug: mFOLFOX6

•Drug: mFOLFOXIRI

Phase:

Phase 3

Study Design:





Outcome Measures:

•Progression-free survival (PFS)time

•Overall survival (OS)

•Control ol lesions

•(Serious) Adverse Events

•Quality of life (QoL)

Enrollment:

507

•Dominik Paul Modest

•German ResearchFoundation

•Institut für KlinischeKrebsforschung IKFGmbH at KrankenhausNordwest

•Charite University,Berlin, Germany

•Charité Universitätsmedizin Berlin,Berlin, Germany

94 NCT05008367 Effect of Dexamethasone asAnalgesic Treatment After Total KneeArthroplasty

Study Documents:



•Postoperative Pain •Drug: Dexamethasone

•Drug: Isotonic saline

Phase:

Phase 4

Study Design:





Outcome Measures:

Cumulative usage of morphine0-48 hours postoperatively

Enrollment:

485

•Naestved Hospital

•Copenhagen TrialUnit, Center forClinical InterventionResearch

•Gildhøj Privathospital,Brøndbyvester, Denmark

•Bispebjerg Hospital, Copenhagen,Denmark

•Sjællands Universitetshospital, Køge,Køge, Denmark

•Næstsved Sygehus, Næstved,Denmark

•Odense Universitetshospital,Odense, Denmark

- of 67 -

















95 NCT05008029 Immobilization Without Reduction vs.Reduction Under General Anesthesiain Metaphyseal Fractures of the DistalRadius

Study Documents:



•Radius Fracture Distal •Procedure: In situimmobilization

•Procedure: Reductionunder general anesthesia

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Upper limb function

•Wrist range of motion

•Ulnar variance

•Deformity

Enrollment:

152

•Instituto de OrtopediaInfantil Roosevelt

•Pontificia UniversidadJaveriana

•Instituto Roosevelt, Bogota,Cundinamarca, Colombia

96 NCT05007613 Second-line Cabozantinib andAtezolizumab in Patients WithRecurrent or Metastatic EsophagealSquamous Cell Carcinoma

Study Documents:



•Esophageal Cancer

•Metastatic Cancer

•Squamous CellCarcinoma

•Drug: Cabozantinib 40MG

•Drug: AtezolizumabInjection

Phase:

Phase 2

Study Design:

•Allocation: N/A




Outcome Measures:

•Overall response rate

•Progression-free survival

•Overall survival

•Safety

Enrollment:

37

•National TaiwanUniversity Hospital

• Ipsen

•Roche Pharma AG

•National Taiwan University Hospital,Taipei City, Taiwan

- of 67 -















97 NCT05002985 Tanglewood Trail Walking Program inRural Kentucky 2020

Study Documents:


Completed Has Results •Dietary Habits •Behavioral: walking groupled by a communityorganizer

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Self-reported Fruit Intake

•Self-reported Vegetable Intake

•Hours of Vigorous Exercise PerWeek

•Hours of Moderate Exercise PerWeek

•Hours of Sitting Per Week

•Hours of Walking Per Week

•Understanding of Plant-basedPhytonutrients

•Belief in the Benefit of Plant-based Nutrients

•Belief in the Preventative Effectsof Plant-Based Nutrients

•Belief in the Role of HealthyDiet in Protecting Health FromPollutants

•Knowledge of Which FoodsContain Phytonutrients

•Knowledge of EnvironmentalPollutants

Enrollment:

49

•Dawn Brewer

•National Institute ofEnvironmental HealthSciences (NIEHS)

•University of Kentucky

•University of Kentucky, Lexington,Kentucky, United States

- of 67 -







98 NCT05002972 Tanglewood Trail Walking Program inRural Kentucky 2019

Study Documents:


Completed Has Results •Dietary Habits •Behavioral: walking groupled by a communityorganizer

Phase:

Not Applicable

Study Design:

•Allocation: N/A




Outcome Measures:

•Carotenoid Levels

•Self-reported Fruit Intake

•Self-reported Vegetable Intake

•A1c Levels

•LDL Cholesterol Levels

•HDL Cholesterol Levels

•Total Cholesterol Levels

•Weight

•Waist Circumference

•Hours of Vigorous Exercise

•and 9 more

Enrollment:

63

•Dawn Brewer

•National Institute ofEnvironmental HealthSciences (NIEHS)

•University of Kentucky

•University of Kentucky, Lexington,Kentucky, United States

99 NCT05001165 Dashboard Activated Services andTele-Health for Heart Failure

Study Documents:



No ResultsAvailable

•Heart Failure WithReduced EjectionFraction

•Other: Proactive PanelManagement Clinics forHFrEF

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Optimization Potential Score

•Change in proportion receivingACE/ARB/ARNI

•Change in proportion receivingbeta-blockers

•Change in proportion receivingMRA

•Change in proportion receivingARNI

•Change in proportion receivingSGLT2i

•Change in Total Hospitalizations

•Change in Total Deaths

Enrollment:

300

•VA Greater LosAngeles HealthcareSystem

•VA West Los Angeles, Los Angeles,California, United States

- of 67 -










100 NCT05000697 Chemoradiation and ConsolidationChemotherapy With or WithoutOxaliplatin for Distal Rectal Cancerand Watch and Wait

Study Documents:



•Rectal Cancer

•Consolidation

•Drug: Oxaliplatin

•Drug: 5FU

Phase:

Not Applicable

Study Design:





Outcome Measures:

•Decision to Watch and Wait dueto clinical complete response

•Surgery-free survival at 3 years

•Total Mesorectal Excision-freesurvival at 3 years

•Distant metastases free survivalat 3 years

•Local regrowth-free survival at 3years

•Colostomy-free survival at 3years

Enrollment:

216

•Hospital AlemãoOswaldo Cruz

•Hospital Alemão Oswaldo Cruz, SãoPaulo, SP, Brazil

16,874 additional studies not shown

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services

- of 67 -





