louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05634265: Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study
Official title: Social Media for ART Adherence and Retention in Adolescents and Young Adults: the Vijana-SMART Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-1-infection
Adherence, Medication
Depression
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 55
Sex: ALL
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-group pilot
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to investigate whether a virtual peer support group improves ART knowledge, adherence, and mental health in youth living with HIV in Kenya.

Detailed description: Adolescents and young adults (AYA) living with HIV show lower ART adherence, higher loss to follow-up and higher AIDS-related mortality than other age groups. Innovative approaches are needed that address AYA's unique needs and improve their adherence and retention in HIV care. There is evidence that peer support and mobile messaging with healthcare workers (HCW) are two strategies that may be effective in this group, but their evaluation has been limited and no interventions have combined them. Since 2014, youth-run virtual support groups have spontaneously started at HIV clinics, using the mobile social media application WhatsApp. These groups present valuable case studies from which the proposed project will develop a structured social media intervention that combines peer and HCW support to improve ART adherence and retention, guided by the preferences of AYA. The SPECIFIC AIMS are to (1) Characterize the existing WhatsApp groups through in-depth interviews with members and detailed content analysis of the group's communications during a 6-week observation period. This will define the elements and features desired by AYA in a social media intervention. (2) Guided by findings from Aim 1, behavioral theory, and the study team's ongoing research on mobile messaging to improve ART adherence, to develop and refine structured content for a reproducible WhatsApp intervention that incorporates peer and HCW interaction. (3) Pilot the structured intervention for 6 months in another clinic and evaluate its impact on intermediate outcomes ART knowledge, depression and stigma.

Eligibility criteria: Inclusion Criteria:

* Living with HIV
* On ART
* Aware of HIV status
* Has access to WhatsApp
* Literate

Primary outcomes:
measure: ART information, motivation, behavioral skills
timeFrame: 6 months
measure: Social support
timeFrame: 6 months
measure: Stigma
timeFrame: 6 months
measure: ART adherence
timeFrame: 6 months
measure: Depression symptoms
timeFrame: 6 months
measure: Resilience
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nairobi
country: Kenya
facility: Kayole
Study officials:
affiliation: University of Washington
name: Keshet Ronen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110965: Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
Official title: Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scoliosis
Scoliosis Idiopathic
Lead sponsor: Manhattan Physical Medicine and Rehabilitation, LLP
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Patient's change in previous X-ray compared with baseline, and baseline compared with X-ray done 4-10 months later
Primary purpose: TREATMENT

Brief summary: The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart.

Detailed description: The investigators obtained baseline Cobb angles on simple and complex curves, and collected previous, earlier studies of each adolescent idiopathic and degenerative scoliosis patient. The investigators then taught them to do the side-plank pose with the convex side of lumbar and thoracolumbar scoliotic curves downward, and a slightly altered version of the the half moon pose of yoga with the convex side of thoracic and cervicothoracic curves downward. The half moon pose was altered in that a belt was looped around the horizontal leg's foot, and held in a vertically extended upper arm's hand, and pulled tightly in that vertical position.

Each pose was held as long as the patient could at least once daily.

Cobb angles were again measured in films taken 4-10 months later.

Eligibility criteria: Inclusion Criteria:

* Scoliosis
* Willingness to do pose at least once daily for 4 -10 months
* Willingness to have a second X-ray 4-10 months after starting to do pose

Exclusion Criteria:

* Neuromuscular disease
* Previous Spinal surgery
* Pregnancy

Primary outcomes:
measure: Change in Cobb angle
timeFrame: 4 - 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Manhattan Physical Medicine and Rehabilitation
state: New York
Study officials:
affiliation: Columbia Medical School
name: Loren M Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01366365: Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide
Official title: A Phase 1 Randomized, Double-Blind, Placebo Controlled Parallel Group Study of the Pharmacokinetics, Safety and Tolerability of Methylnaltrexone Bromide Administered as Single and Multiple Intravenous Doses to Healthy Adults and Elderly Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This double-blind, randomized, two-cohort, placebo-controlled, parallel group study characterized the pharmacokinetics, safety, and tolerability of MNTX following single doses and at steady-state during multiple dosing and assessed the effects of aging on the pharmacokinetics, safety and tolerability of MNTX.


Eligibility criteria: Inclusion Criteria:

1. Healthy Males and females who were between the ages of 18 and 45 years and healthy males and females who were 65 years of age and older.
2. Subjects who were non-smokers
3. Subjects with body weights within range of 70-100 kg (154-220 lbs).

Exclusion Criteria:

1. Subjects who had previously been exposed to MNTX
2. Subjects with a history of vasovagal episodes or fainting within the past five years
3. Subjects with a history of psychiatric or neurologic disorder
4. Subjects with a history of narrow-angle glaucoma or intraocular hypertension
5. Subjects who had tested positive for hepatitis B surface antigen, IgM hepatitis B core antibody, hepatitis C antibody, or HIV
6. Subjects who have had a diagnosis of alcohol or substance dependence.

Primary outcomes:
measure: Clearance of MNTX
timeFrame: 7 days
Secondary outcomes:
measure: Half-life of MNTX
timeFrame: 7 days
measure: Volume of distribution of MNTX
timeFrame: 7 days
measure: Area under the plasma concentration (AUC) of MNTX
timeFrame: 7 days
measure: Number of Subjects with Adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals, Inc.
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05362565: Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity
Official title: Genetic Research of Monogenic Obesity in a Pediatric Cohort With Severe and Early Onset Obesity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Monogenic Obesity
Keywords: monogenic obesity
pediatric
early onset obesity
genetic disease
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-05-05
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with a Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5.

Brief summary: Obesity is a frequent disease mainly caused by environmental/polygenic factors and more rarely caused by the alteration of a single gene ("monogenic obesity"). The diagnosis of these rare forms can lead to personalized management (new treatments, prognosis, adapted hygienic and dietary rules) and family screening. The use of a panel covering the known causes of monogenic obesity on a pediatric cohort of severe and early obesity will allow to evaluate the relevance of these analyses to adapt the management of this type of patients.


Eligibility criteria: Inclusion Criteria:

* Recruitment age: 2-17 years
* Body mass index, greater than the International Obesity Task Force (IOTF) 30 curve before the age of 5
* Care at the specialized pediatric obesity center (CSO) of the Bordeaux University Hospital
* Informed consent signed

Exclusion Criteria:

* no informed consent

Primary outcomes:
measure: Positivity rate of patients for whom a diagnosis of monogenic obesity will be obtained when all analyses have been performed.
timeFrame: Inclusion visit
Secondary outcomes:
measure: Number of Patients eligible for a drug targeting single-gene obesity
timeFrame: Inclusion visit
measure: Number of patients for whom a genetic finding will have changed management and description of changes.
timeFrame: Inclusion visit
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
References:
Clinical trial NCT03788265: Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis
Official title: Efficacy of Autologous Micro-fragmented Adipose Tissue Intra-articular Injection for Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability, reduced range of motion, and functional limitations. Current treatment has various limitations so that alternative options to restore function and alleviate joint pain, with the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue through mild mechanical force. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems.


Eligibility criteria: Inclusion Criteria:

* Age of eighteen or older
* Diagnosis of symptomatic knee osteoarthritis
* Radiographic evidence of knee osteoarthritis
* Failure of conservative treatment

Exclusion Criteria:

* Treatment with any intra-articular knee injection within 8 weeks before surgery
* Any disease or condition potential to interfere study outcome
* Under 18 years of age

Primary outcomes:
measure: Change in Visual Analog Pain Scale (VAS) Over Time
timeFrame: Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
Secondary outcomes:
measure: Change in the knee injury and osteoarthritis score (KOOS) Over Time
timeFrame: Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated hospital, school of medicine, Zhejiang Uni.
state: Zhejiang
Study officials:
References:
Clinical trial NCT04335565: Stevia Extract and Glucose Homeostasis
Official title: Effect of Stevia Extract on Postprandial Glucose Response and Satiety in Overweight and Obese Adults: A Three-arm Crossover Trial.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Overweight
Obesity
Keywords: Non-nutritive sweeteners
postprandial glucose
diabetes
obesity
satiety
Lead sponsor: Liverpool Hope University
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 0
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: PREVENTION

Brief summary: This study aims to assess the effect of stevia extract on postprandial glucose and insulin levels in overweight and obese adults when compared to sugar and water.

Detailed description: The study is a three-arm crossover trial involving participants attending the Lab on 3 different occasions (separated by 3-5 day washout period), where they will be administered water, sugar solution (65g), water and stevia extract (5g) solution. The solution will be followed by a consumption of a fixed meal (after 30 minutes). Breakfast will be standardised. Capillary blood glucose will be collected every 30 min until 2 hours post meal. Venous blood samples will be collected before the intake of the solution and at 2 hours after meal intake.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* BMI 27-40 Kg/m2
* Males and females

Exclusion Criteria:

* Athletes
* Pregnant or breastfeeding women
* Patients with chronic disease (diabetes, CVD etc...).

Primary outcomes:
measure: Postprandial glucose levels
timeFrame: Capillary blood glucose will be measured two hours after the administration of a fixed meal.
Secondary outcomes:
measure: Postprandial insulin levels
timeFrame: Postprandial insulin levels will be measured two hours of the administration of a fixed meal
measure: Area under the curve (AUC) for glucose
timeFrame: Capillary blood glucose levels will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch
measure: Subjective feelings of satiety
timeFrame: VAS will be collected 6 times on each visit before the intake of the solution until 2 hours post lunch.
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: School of Health sciences, Liverpool Hope University
Study officials:
affiliation: Liverpool Hope University
name: Farzad Amirabdollahian, PhD
role: STUDY_CHAIR
References:
citation: Farhat G, Berset V, Moore L. Effects of Stevia Extract on Postprandial Glucose Response, Satiety and Energy Intake: A Three-Arm Crossover Trial. Nutrients. 2019 Dec 12;11(12):3036. doi: 10.3390/nu11123036.
Clinical trial NCT02132065: Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation
Official title: Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopic Nephrectomy
TAP Block
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy, assessment of benefit and opioid reduction.

Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which infiltrates local anesthetic between the internal oblique and transverse abdominis muscles and provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12) abdominal wall bilaterally using a four-point single-shot technique.

Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain may have harmful physiologic, psychological consequences which potentially increase the morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8).

Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the need of morphine postoperatively after radical nephrectomy.

Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to routine analgesic. To assess the difference in morphine usage in the first 48 hours after radical nephrectomy with or without applying of unilaterally dual TAP block.


Eligibility criteria: Inclusion Criteria:

-Any patient undergoing laparoscopic nephrectomy- -Age ranges 18-80- -Can read and understand Danish- -Able to give informed consent

Exclusion Criteria:

-History of relevant drug allergy- -Inability to understand written consent forms or give consent- -Age less than 18 or over 80- -Any conversion to open surgery-

-Patients included in ambulant nephrectomy project.

Primary outcomes:
measure: Pain score
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Roskilde Hospital
Study officials:
affiliation: Roskilde Hospital, Department of Urology
name: Nessn H. Azawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00018265: Fitness and Daily Function in Adults
Official title: Oxygen Kinetics, Mobility Task Performance, and Task Training in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Disease
Keywords: Rehabilitation
exercise test
aging
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the impact of aerobic fitness on the ability of able and disabled older adults to perform daily functional activities. Subjects are tested in their oxygen use patterns as they perform a series of functional tasks (such as walking on stairs) and following a 24-week training program focused on improving the ability to perform daily tasks likely requiring aerobic fitness (such as walking on stairs).


Eligibility criteria: Both healthy and self-reported mobility-impaired older adults

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Ann Arbor Healthcare System
state: Michigan
Study officials:
name: Donald Dengel
References:
Clinical trial NCT01306565: High Dose and Low Dose of Atorvastatin in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)
Official title: Comparison Between Effect of High Dose and Low Dose of Atorvastatin in Reduction Level of CRP in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Unstable angina
NSTMI
Statin
Atorvastatin
Lead sponsor: Hormozgan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-02
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the effect of high dose and low dose of Atorvastatin in reduction level of C-reactive protein (CRP) in patients with unstable angina and NSTEMI (Non ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas.

Detailed description: This study compare the effect of 80mg atorvastatin followed by two 20mg daily atorvastatin with three 80mg daily atorvastatin in reduction of CRP in patients with unstable angina and NSTEMI (Non ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas in 2009.

Eligibility criteria: Inclusion Criteria:

* Patients with unstable angina with chest discomfort at rest with normal EKG or St depression (at least 0.1mv) in two consecutive leads or new and deep T inversion (at least 0.2mv)

Exclusion Criteria:

* Myocardial Infarction with ST elevation
* Diabetes Mellitus
* Previous statin use
* Current infectious disease

Primary outcomes:
measure: CRP reduction
timeFrame: 72 hours
Secondary outcomes:
measure: Drug side effects
timeFrame: 72 hours
Other outcomes:
Locations:
city: Bandar Abbas
country: Iran, Islamic Republic of
facility: Hormozgan University of Medical Sciences
state: Hormozgan
Study officials:
affiliation: Hormozgan University of Medical Sciences
name: Vahid Vahdatkhah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03694665: Monitoring Lung Recruitment Maneuver in Anesthetized Morbidly Obese
Official title: Non-invasive Assessment of Lung Recruitment in Morbid Obese Patients Undergoing Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atelectasis
Keywords: airways pressure
mechanical ventilation
Atelectasis
Lead sponsor: Hospital Privado de Comunidad de Mar del Plata
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Morbid obese patients present changes in respiratory physiology caused by weight overload. Intraoperative atelectasis is a pulmonary complication that affects not only gas exchange but also respiratory mechanics. The present study was aimed to test the role of different parameters for monitoring the treatment of atelectasis by a lung recruitment maneuver.

Detailed description: This is a prospective study perform in 30 anesthetized morbidly obese undergoing bariatric surgery. Lung mechanics and volumetric capnography will be non-invasively assessed during laparoscopy. Esophageal pressure will be measured by an esophageal balloon to measure transpulmonary pressure. A lung recruitment maneuver will be done. The optimum level of positive end-expiratory pressure (PEEP) is defined as the PEEP level when transpulmonary pressure remains positive during the PEEP titration trial of the recruitment maneuver. Lung collapse is detected when transpulmonary pressure becomes negative. The behavior of the studied volumetric capnography and lung mechanics parameters will be compared with the reference transpulmonary pressure signal.

Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) \> 40 kg/m2
* Written inform consent
* Scheduled for bariatric surgery
* American Society of Anesthesia physical status II-III

Exclusion Criteria:

* Acute pulmonary disease
* Emergency surgery

Primary outcomes:
measure: Measurement of the optimum positive end-expiratory pressure in anesthetized morbidly obese patients
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Mar del Plata
country: Argentina
facility: Hospital Privado de Comunidad
state: Buenos Aires
Study officials:
affiliation: Hospital Privado de Comunidad
name: Gerardo Tusman, MD
role: PRINCIPAL_INVESTIGATOR
References: