louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05638516: Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product
Official title: Improving Mental Health in Youth and Lowering Risk for Obesity Through a Digital Preventative Product
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Disorder
Obesity
Overweight
Lead sponsor: Ksana Health
Sponsor class: INDUSTRY
Collaborators: name: Novo Nordisk A/S
First posted: 2022-12-06
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this study is to test the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in youth (aged 18-25 years) with elevated depressive symptoms who are overweight/obese and/or self-report parental history of overweight/obesity.

Eligible participants will be randomly assigned to one of two groups: one group will use the Vira mobile app intervention with support from a health coach, and the other group will use the Vira mobile app intervention without coaching. Both groups will use the app for 12 weeks.

Detailed description: The primary aim of this project is to examine the feasibility and utilization of a redesigned mobile app and health coaching platform (Vira) in a 2 x 2 (gender x condition) designed pilot study in a sample of 100 youth (18-25 years old) with (1) elevated depressive symptoms (PHQ-8 score ≥10) and (2) overweight/obesity (BMI ≥ 25 and/or reporting a parental history of overweight/obesity). The study will examine the feasibility and utilization of the mobile app intervention with coaching compared to that of the mobile app intervention without coaching.

This is an exploratory pilot study; therefore, no formal sample size calculation was conducted. It is anticipated that 1,000 individuals will be screened, of which 20% will be eligible, and that 50% of those eligible will agree to participate (final N = 100, 50 per arm).

Eligibility criteria: Inclusion Criteria:

* Age 18-25
* Live in the United States
* English fluency and literacy
* Have access to an Android or iOS device
* Elevated depressive symptoms (PHQ-8 score of 10 or above)
* Overweight (BMI of 25 or above) OR reporting a parental history of overweight or obesity

Exclusion Criteria:

* Previous participation in this study
* Major mental or physical illness that will interfere with completing intervention and/or assessment activities.

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: 12 weeks
measure: Number of active days in the Vira mobile app intervention and health coaching platform
timeFrame: 12 weeks
measure: Number of features used
timeFrame: 12 weeks
measure: Acceptability of the mobile app intervention
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Ksana Health
state: Oregon
Study officials:
affiliation: Ksana Health
name: Nick Allen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01765816: Generation 100: Blood Volume and Cardiac Function in Healthy Aging
Official title: Generation 100: How Exercise Affects Mortality and Morbidity in the Elderly: A Randomized Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ageing
Keywords: Exercise
Elderly
Blood volume
Hemoglobin
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 25
Sex: ALL
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hypothesis: Exercise will reduce morbidity and mortality rates in an elderly population. The extent of reduction will be intensity dependent.

As part of the "Generation 100" study, this sub-study project will investigate the effect of exercise on blood volume, cardiopulmonary health and heart function in healthy aging. Objective is to determine the acute effect of one endurance training session on blood volume in healthy elderly. The working hypothesis is that one interval training session increases total blood volume by 10% in healthy elderly, and that there will be no change after moderate continuous training.


Eligibility criteria: Inclusion Criteria:

* ability to walk at least 1km,
* born in 1938,1939,1940,1941 or 1942
* Sufficiently good health to be able to take part in the study, as determined by the researchers

Exclusion Criteria:

* Illness or disability that precludes exercise or hinders completion of the study
* Uncontrolled hypertension
* Symptomatic valve disease, hyper tropic cardio-myopathy or unstable angina
* Active cancer
* Test results indicating that study participation is unsafe
* Inclusion in other studies conflicting with participation in this one

Primary outcomes:
measure: total blood volume
timeFrame: 24 hours
Secondary outcomes:
measure: hemoglobin volume
timeFrame: 24 hours
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: Norwegian University of Science and Technology
name: Ulrik Wisløff, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00814216: Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients
Official title: Randomized, Double-blind, Two Way Cross-over, Proof of Concept Study to Compare Efficacy, Safety, Pharmacokinetics & Pharmacodynamics of QAV680 Versus Placebo, With an Extended Open-label Corticosteroid Period, in Steroid-free, Mild to Moderate Persistent Asthma Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Efficacy
safety
QAV680
pharmacokinetics
corticosteroid
asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-12-24
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to study the efficacy (as measured by change in FEV1) and safety of two-week administration of oral QAV680 in the treatment of patients with asthma.'


Eligibility criteria: Inclusion criteria:

* Mild to moderate persistent asthma for at least 6 months.

Exclusion criteria:

* Past or recent history of significant medical illness and/or lab abnormalities including but not limited to ECG abnormalities, abnormal LFT, HIV, Hep B/C,
* Allergic disorders, pancreatic disease, serious underlying respiratory diseases, life threatening asthma, renal disease etc
* Surgical and/or medical conditions which significantly effect ADME of the drug.
* Prior use of asthma medications (except SABA's) prior to 2 weeks of dosing

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Measure: Change in Forced Expiratory Volume in one second (FEV1) as measured by Spirometry.
timeFrame: 2 weeks
Secondary outcomes:
measure: Measure: Change in Asthma Control Questionnaire (ACQ) score
timeFrame: 2 weeks
measure: Measure: Frequency of salbutamol usage
timeFrame: 2 weeks
measure: Measure: Change in exhaled Nitric Oxide (NO)
timeFrame: 2 weeks
measure: Home Monitoring Of FEV1 By PIKO Monitors
timeFrame: Day 2 to Day 13
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Munich
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Ahmedabad
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: Mysore
country: India
facility: Novartis Investigative Site
city: Nagpur
country: India
facility: Novartis Investigative SIte
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00645216: Study Examing The Effect of Grapefruit Juice On The Blood And Urine Samples of Study Drug And Its By Product And Safety
Official title: A Phase 1, Open Label, Randomized, Fixed Sequence Study To Evaluate The Effect Of Multiple Dose Administration Of Grapefruit Juice On The Multiple Dose Pharmacokinetics Of CP-945,598 In Healthy Overweight And Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CP-945,598 is eliminated primarily by enzyme CYP3A. Grapefruit juice may affect the activity of CYP3A and alter the amount of CP-945,598 in the blood. This study will therefore compare the time course of drug concentrations in the body, safety and tolerability of CP-945,598 given with or without grapefruit juice in healthy obese/overweight subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects between the ages of 18 and 55 years.
2. Body Mass Index (BMI) of 27 to 40 kg/m2.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.

Exclusion Criteria:

* Non-prescribed use of drugs of abuse/ recreational drugs;
* Recent treatment with experimental drugs or herbal experiments;
* EKG and blood pressure parameters falling outside of protocol-specified limits;
* History of regular alcohol or tobacco use exceeding protocol-specified limits; grapefruit juice intolerance.

Primary outcomes:
measure: Measurement of durg and metabolite concentrations in serum from blood sampling collected at various times over 24 hours dosing interval on Day 7 and 21, before dosing on days 5,6, 12, 13, 14, 19 and 20.
timeFrame: 21 days
measure: Safetey laboratory tests (chemistry, hematology, urinalysis) on Days -1 and 22
timeFrame: 21 days
measure: Adverse event monitoring throughout duration of the study
timeFrame: 21 days
Secondary outcomes:
measure: Urinary 6-β-hydroxycortisol:cortisol ratios (CMR) on Days 0 and 21.
timeFrame: 2 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03529916: Endothelial Cell Gene Networks of CVD
Official title: Endothelial Cell Gene Networks of CVD
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Heart Disease
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2018-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Both CVD and healthy subjects

Brief summary: The objective of this study is to identify relevant signature gene networks of cardiovascular disease in endothelial cells derived from circulating endothelial progenitor cells of individuals with established cardiovascular disease (CVD).

Detailed description: The investigators propose to enroll CVD and healthy subjects between 30 and 60 years of age, matched for age, gender, body mass index, and medication (statin and anti-hypertensive) use. Circulating endothelial progenitor cells will be isolated from blood and cultured in vitro to differentiate into endothelial cells.

Eligibility criteria: Inclusion Criteria for CVD subjects::

• \>50% stenosis of one or more coronary arteries

Inclusion Criteria for Healthy subjects:

• absence of coronary artery stenosis

Exclusion Criteria for all subjects:

* type 2 diabetes mellitus
* chronic kidney disease,
* other chronic diseases
* dyslipidemia (fasting plasma LDL-C \>160 mg/dL and triglyceride levels \>150 mg/dL)

Primary outcomes:
measure: Gene expression
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center - Cardiovascular Clinic
state: Massachusetts
Study officials:
affiliation: Tufts University
name: Stefania Lamon-Fava, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417716: Use of Intravitreal Bevacizumab in Patients With Diffuse Diabetic Macular Edema
Official title: The Efficacy of a Single Intravitreal Injection of Bevacizumab in Patients With Diffuse Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2
Diabetic Macular Edema
Keywords: Diffuse Diabetic Macular Edema
Intravitreal Bevacizumab
Anti-VEGF drugs
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2007-01-04
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Intravitreal Bevacizumab is an effective treatment for the diffuse diabetic macular edema

Detailed description: A non-randomized prospective clinical interventional study which includes 45 non previously treated patients with DME. The patients received a single intravitreal injection of 2.5 mg bevacizumab. Follow-up included clinical examination (best corrected visual acuity (BCVA, intraocular pressure (IOP), cataract grading, DME characteristics and systemic check-up) pre-injection, at first visit, at weeks 1 and 2 and months 1 and 3. OCT and fluorescein angiography was evaluated at months 1 and 3.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Macular edema involving the center of the macula demonstrated on OCT
* Clear ocular media
* Untreated patients
* Older than 45 years
* BCVA of the fellow eye at least 20/100

Exclusion Criteria:

* Renal diabetic disease, uncontrolled hypertension or stroke history
* Other ocular disease
* Ocular surgery excepting uncomplicated phacoemulsification
* History of photocoagulation (panretinal or focal)
* History of another intravitreal treatment (like triamcinolone)

Primary outcomes:
measure: BCVA
measure: Fluorescein Angiography
measure: Optical Coherence Tomography
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico city
country: Mexico
facility: Asociación para Evitar la Ceguera en México
state: Distrito Federal
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Adriana Solís-Vivanco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación para Evitar la Ceguera en México
name: Jans Fromow-Guerra, MD PhD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Elizabeth Reyna-Castelán
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Juan M Jiménez-Sierra, MD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Myriam Hernández-Rojas, MD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Griselda Alvarez-Rivera, MD
role: STUDY_CHAIR
affiliation: Asociación para Evitar la Ceguera en México
name: Hugo Quiroz-Mercado, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01586416: Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
Official title: Intervention to Increase Chemotherapy Tolerance in Elderly Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Neoplasms
Keywords: Colonic neoplasms
Older adults
Psychosocial Intervention
Chemotherapy adherence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-26
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to develop and pilot test a behavioral intervention for elderly adults in treatment for colon cancer, to enhance their skills for managing the challenges of completing chemotherapy regimens. The investigators will assess feasibility and acceptability of the intervention, and explore preliminary efficacy of the intervention for reducing psychological distress and improving rates of optimal chemotherapy adherence.


Eligibility criteria: Inclusion Criteria:

* Age 60 or older
* Verbal fluency in English
* Diagnosis of colon cancer
* Scheduled to initiate chemotherapy treatment for colon cancer

Exclusion Criteria:

* Active, unstable, untreated serious mental illness interfering with ability to participate
* Cognitive impairment interfering with ability to participate
* Receiving radiotherapy concomitant with chemotherapy

Primary outcomes:
measure: Participant satisfaction with intervention structure, timing and content
timeFrame: At approximately 12 weeks post-baseline
measure: Number of participants who withdraw from study after enrollment
timeFrame: At approximately 12 weeks post-baseline
Secondary outcomes:
measure: Change from baseline in the Hospital Anxiety and Depression Scale
timeFrame: At approximately 12 weeks post-baseline
measure: Change from baseline in the Symptom Distress Scale
timeFrame: At approximately 12 weeks post-baseline
measure: Proportion of each chemotherapy component administered during the treatment regimen relative to the total planned amount
timeFrame: At approximately 24 weeks post-baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Lara Traeger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02357316: Heritability and Genetics of Fat Taste
Official title: Heritability and Genetics of Fat Taste
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Taste responses of healthy individuals
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Denver Museum of Nature & Science
First posted: 2015-02-06
Enrollment: 2500
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals ages 8 and older

Brief summary: The investigators seek to determine how genetics and the environment influence the ability to taste and smell fat. The investigators believe that people who consume higher fat diets and people who have higher body fat levels are less able to taste and smell fat. The investigators expect to see that people who are less able to taste and smell fat will share certain genetic differences.


Eligibility criteria: Inclusion Criteria:

* Willingness to participate
* Ages 8 and older

Exclusion Criteria:

* Younger than 8 years old

Primary outcomes:
measure: Taste sensitivity
timeFrame: At visit
measure: Genotype
timeFrame: At visit
measure: Anthropometric measures
timeFrame: At visit
measure: Dietary data
timeFrame: At visit
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Museum of Nature & Science
state: Colorado
Study officials:
References:
Clinical trial NCT00807716: Effect of Physiotherapy After Total Knee Replacement
Official title: The Immediate and Long Term Effects of a Walking-skill Program Compared to Usual Physiotherapy Care in Patients Who Have Undergone Total Knee Arthroplasty (TKA): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: physiotherapy
functional outcome
activity level
self efficacy
task oriented exercises
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2008-12-12
Enrollment: 57
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Physiotherapy plays an important part in rehabilitation after total knee arthroplasty. Even if this is a common practice, few studies have been performed on this issue.

The prime aim of this study is to examine the effects of an ambulatory individualized task-oriented exercise program compared with current ambulatory physiotherapy(usual care)on activity performance and self efficacy beliefs in the time span 6 weeks to 3 months after total knee arthroplasty with a follow-up at twelve months.

HO:Task oriented physiotherapy has better effect than usual care on activity performance and self-efficacy beliefs in the time span 6 weeks to 3 months after total knee replacement.

Detailed description: A randomized controlled trial was performed with an experiment group having task oriented exercises in only weight-bearing 12 times from 6 weeks to 12 weeks after the operation, while the control group had usual physiotherapy care during the same time span. The primary outcome was walking measured by the six minutes walk test. Other performed and self reported measures of physical functioning were performed, at baseline, six weeks after the operation, immediately after the intervention at 12-14 weeks and with a follow-up nine months after the intervention.

Eligibility criteria: Inclusion Criteria:

* Primary gonarthrosis
* Good written and oral understanding of Norwegian
* Good cognitive function

Exclusion Criteria:

* Severe gonarthrosis in the other knee or coxarthrosis
* Neurological disorders or rheumatoid arthritis

Primary outcomes:
measure: 6 minutes walk test
timeFrame: preoperatively, baseline at 6 weeks, after the intervention at 3 months, 12onths
Secondary outcomes:
measure: Self reported pain and activity level(KOOS)
timeFrame: preoperatively, 6 weeks, 3 months and 12 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Section of Nursing and Health Science, University of Oslo
Study officials:
affiliation: professor
name: Anne Marit Mengshoel, PhD
role: STUDY_DIRECTOR
References: