cyrilzakka/clinical-trials huggingface dataset:
Strength Training for Men Living With Obesity

Emerging evidence suggests that alternative obesity management strategies need to address barriers to engaging with regular physical activity to adopt healthier lifestyles. It is hypothesized that more men living with obesity who are exposed to an online home-based circuit strength training for 12 weeks will be more physically active, 34 weeks after the intervention compared with people who are not exposed to the program.

Sixty men (age ≥ 18 years; body fat % ≥ 25) were randomly assigned to the intervention group (N=30) or the control condition (N=30) for 12 weeks. The intervention group did the online delivered circuit training, three sessions in a week. Adherence to the weekly physical activity guidelines was evaluated 46 weeks after being enrolled in the program using a heart rate tracker and an exercise log. Most variables (anthropometrics, body composition, resting heart rate, blood pressure, lipids profile, glucose) were measured at baseline and after 12, 24, and 46 weeks. Aerobic fitness and comfort with technology were measured at baseline. Perceived benefits/barriers of participation in exercise were captured at baseline and 12 weeks.

More participants in the intervention group adhered to the physical activity guidelines compared to the control group at 46 weeks (intervention 36.8% vs control 5.3%; p=0.021). However, the intervention group did not improve their health outcomes after 12, 24, and 46 weeks. Fewer barriers were reported after 12-week for the intervention group (p=0.02).

Eligibility Criteria:
Inclusion Criteria:

* men
* Body fat% of 25% or more
* Not reaching physical activity guidelines (150 min of moderate to vigorous intensity of aerobic exercises + two sessions of resistance training)
* being able to do weight training

Exclusion Criteria:

- Taking medications that can cause to change in heart rate
Vitamin C for the Prevention of UTI in Women Who Undergo Elective Gynecological Surgeries

This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC).

Exclusion Criteria:

* Any women with the following:

  1. Nephrolithiasis
  2. Congenital anomaly or neurogenic bladder
  3. Allergy to ascorbic acid
  4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery
  5. Surgery did involve a fistula repair or a vaginal mesh removal
  6. Positive Urinalysis in the PAU
  7. Recurrent UTI's
  8. Diabetes
  9. G6PD
  10. Hemochromatosis
  11. Renal disorders

Patients already taking Vitamin C supplementation will also be excluded from the study.
Culturally Tailored Diabetes Education on Self-Management of Adult Hispanic Males With Type 2 Diabetes Mellitus

Diabetes mellitus (DM) is a global public health concern. In the United States, adult Hispanic males are particularly vulnerable to type 2 diabetes mellitus and are more likely to develop complications and subsequently die from it, compared to non-Hispanic White males. Evidence suggests good self-management behaviors can potentially prevent disease-related complications and improve clinical outcomes. The American Diabetes Association and Association of Diabetes Care and Education Specialists have endorsed diabetes self-management education as a necessary component of care for all individuals living with the disease. However, adult Hispanic males with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S., especially those who are underserved, typically lack access to formal diabetes self-management education (DSME). Further, the majority have never participated in such educational activities (Au et al., 2021; New Jersey Department of Health, 2013; 2017; 2023). A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe (Abraham et al., 2020; Dietz et al., 2022; ElGerges, 2020; Gehlawat et al., 2019; Hailu et al., 2019; Jiang et al., 2022; Leong et al., 2022; Oluchina, 2022; Riangkam et al., 2022; Tamiru et al., 2023; Yu et al., 2022; Zheng et al., 2019). The purpose of the proposed study is to examine the effect of culturally tailored diabetes education on self-management behaviors of adult Hispanic males, aged 18-64 years, with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S. This study can shed more light on the effectiveness of community-based, culturally tailored diabetes educational activities in this vulnerable population and guide future efforts towards enhancing self-management.


Eligibility Criteria:
Inclusion Criteria:

* Age: Adult Hispanic males 18-64 at time of study intervention.
* Diagnosis Codes: Patients with self-reported diagnosis of T2DM without complex, co-morbid conditions such as severe kidney disease and terminal illnesses such as cancer.
* English or Spanish speaking

Exclusion Criteria:

* Outside the age range listed above
* Without a diagnosis of type 2 diabetes
Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.

The main objective of this study is to determine the benefit of the Chalaxie pedagogical evaluation tool in the management of overweight or obese children with intellectual disability.

Chalaxie is a software developped as a pedagogical evaluation tool. It is used in the therapeutic education of overweight and obese children and allow the clinican to explore several skills of the child, such as self-esteem.

Secondary objectives

1. To assess the feasibility of the Chalaxie tool use during a medical visit;
2. To assess the relevance of the Chalaxie tool for the pediatrician;
3. To describe the characteristics of the patients followed at the "Réseau ODE";
4. To evaluate patient self-esteem.

Conduct of research After receiving written consent from the study participant and parental authority, the patients will have two visits with the pediatrician during which they will use the Chalaxie pedagogical evaluation tool. At the first visit, they will use the self-esteem assessment module. At the second visit (i.e. final visit), which should take place between 3 weeks and 2 months after the first visit, they will use a module of their choice.

Eligibility Criteria:
Inclusion Criteria:

* Minor patient of 11 years of age or older
* Overweight or obese patient respectively defined as a BMI ≥ IOTF 25 and ≥ IOTF 30
* Mild intellectual disability defined as intelligence quotient (IQ) ≥ 55 and \<70 or (if IQ unknown) patient in a special education institution (ULIS, IM-PRO)
* Affiliated or beneficiary of a social security scheme
* Written consent of the patient and one of the parental authority holder

Exclusion Criteria:

* Patient with a severe autistic disorder
* Patient who already used the Chalaxie tool during his/her follow-up
* Difficulties in understanding the instructions for using the software and/or difficulties in using a computer
ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Study to evaluate efficacy of fingolimod in patients with neutralizing antibodies over 12 months


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18-65 years
* Subjects with relapsing remitting MS defined by 2010 revised McDonald criteria
* Patients with Expanded Disability Status Scale (EDSS) score of 0-6.5
* Interferon-beta (IFN-β) treatment for at least 18 months.
* Positive IFN-NAb titer at screening or within 6 months prior to screening
* Patients with disease activity despite treatment with IFN-ß measured by gadolinium-enhancing lesions on T1-weighted images on MRI using a triple-dose gadolinium protocol and/or new or newly enlarging T2 lesions (T2 lesions: compared to a reference MRI performed within the last 18 months)

Exclusion Criteria:

* patients with previous or current disease of immune system
* active infections
* cardiovascular risk patients
* Patients unable to undergo MRI scans, including claustrophobia or history of hypersensitivity to gadolinium-DTPA

Other protocol-defined inclusion/exclusion criteria may apply
A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee

Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee.

Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.

This is a multi-center, randomized, double-blind, double-dummy, parallel, placebo- and positive-control (naproxen), dose-ranging study to assess the efficacy and safety of 3 oral doses of PLA-695 administered QD and 1 dose of PLA-695 administered BID for 6 weeks. Subjects will be randomized to 1 of 6 treatment groups: PLA-695 50 mg, 200 mg, or 400 mg QD, PLA-695 200 mg BID, placebo, or naproxen 500 mg BID. Subjects will undergo a washout period of 2 to 14 days. The number of days for washout will be determined by the pre-study NSAID of each subject. Subjects who washout from previous therapy with an increase in signs and symptoms of OA will be randomly assigned to receive PLA-695.

Eligibility Criteria:
Inclusion Criteria: The main inclusion criteria is listed below, additional inclusion criteria is in the protocol.

* Men or women 50 to 75 years of age. Women must be of non-childbearing potential. Sexually active men who are not surgically sterile must agree and commit to use of barrier contraception during the study and for at least 12 weeks after the last dose of PLA.
* Diagnosed with idiopathic OA of the knee for at least 3 months duration in accordance with \[1986\] American College of Rheumatology (ACR) clinical and radiographic criteria: knee pain, the presence of osteophytes, and any one of the following: age \>50 years, crepitus, or morning stiffness \<30 minutes.
* Radiographic confirmation of OA at the target joint (weight-bearing anteroposterior and lateral views) within 1 year of screening.
* Must be currently treated for OA with a stable daily dose of 1 NSAID, including COX-2 inhibitors, not exceeding the maximum recommended dose in the product label, and taken as prescribed by the physician, starting at least 4 weeks before the screening visit.

Exclusion Criteria: These are some of the main exclusion criteria for the the study. Additional exclusion are included in the protocol.

* History of or suspected current esophageal or gastrointestinal bleeding, ulcers, obstruction, or perforation, or pancreatitis.
* Grade 4 severity on the Kellgren-Lawrence Scale on the screening target knee radiograph.
* Any significant cardiovascular, hematologic, blood dyscrasia, endocrine, respiratory, neurologic, psychiatric, metabolic, immunologic, infectious, hepatic, or renal condition that the investigator considers detrimental to the subject's participating in the study or that may prevent the successful completion of the study.
* Any clinically significant laboratory abnormality.
Chronic Hepatitis B Virus Clinical Epidemiology in a Representative Sample of Zambian Adults

The purpose of this study is to recruit a random and representative sample of individuals within several Zambian communities for markers of Hepatitis B Virus (HBV) and to characterize chronic HBV infection and indications for treatment.

The Zambian Ministry of Health (MoH) considers viral hepatitis a significant public health threat; however, there are limited representative data on HBV burden, risk factors, clinical significance, and interaction with co-infections and co-morbidities that are common in Zambia. In collaboration with the Central Statistical Office, MoH, and Centers for Disease Control and Prevention, the Zambia Population-Based HIV Impact Assessment (ZAMPHIA) will be testing a representative sample of Zambians across all 10 provinces for HBV infection. This is an important first step toward understanding the burden of disease and its distribution across the country. The goal of this study is to generate further information for consumption by local and regional health policymakers. The Investigators will research the epidemiologic risk factors for lifetime and current HBV infection, characterize clinical features of chronic HIV in Zambia, and describe key virological, serological, and comorbid factors that are critical to developing the best policies for HBV control in Zambia.

Eligibility Criteria:
Inclusion Criteria:

* Part 1: 18 years or older, current residence in selected household
* Part 2: Participant in part 1 of the study, HBsAg-positive by rapid point-of-care test

Exclusion Criteria:

* Part 1: Unable to provide informed consent
* Part 2: Unwilling to travel to a hospital in their province
Multi-electrocoagulation Retinectomy for Retinal Re-detachment in Silicone Oil Filled Eye

Retinal re-detachment in silicone oil filled eye, especially in the traumatic eye, is a complex retinal detachment with poor prognosis.

In this study, the investigators try to apply a modified surgery as Multi-electrocoagulation retinectomy to reattach the retina. Here the investigators aimed to explore the safety and efficacy of this new surgical approach

The relaxing retinectomy is a useful surgery for retinal re-detachment in eyes with silicone oil filled. However, it has some obvious disadvantages such as the cut of the normal retina surrounding, leaving a large area of retinal deficiency and significant exposure of retinal pigment epithelium and choroid membranes.

In this study, we try to apply a modified surgery named Multi-electrocoagulation retinectomy to re-attach the retina.

Instead of cutting through the proliferated retina directly, this new surgical approach adopts to cut the retina apart in a honeycomb shape with the help of electrocoagulation.

In this way, we not only relax the traction of the proliferative membranes, but also reserve the rest retina to cover the RPE layers.

Based on the hypothesis above, we are aiming to explore the safety and efficacy of this new surgical approach

Eligibility Criteria:
Inclusion Criteria:

1. Age 5-60 years, male or female
2. The primary retinal detachment was caused by ocular trauma, and the vitreous body is filled with silicone oil now.
3. The presence of inferior retinal re-detachment located among 3-9 o'clock.

Exclusion Criteria:

1. The primary retinal detachment was not caused by ocular trauma.
2. Location of the re-detached retina is not mainly in the inferior of the eye.
3. The fundus is unobservable because of severe corneal opacity.
4. The contralateral eye is non-functional
5. Serious heart, lung, liver and kidney dysfunction
Ciprofloxacin Intralesional Injection for the Treatment of Cutaneous Leishmaniasis Compared to Sodium Stibogluconate

The Aim of the trial to evaluate the effectiveness of intralesional ciprofloxacin 0.2% solution as a local injection in treating cutaneous leishmaniasis and compare its effect with intralesional sodium stibogluconate (SSG) 10% intravenous solution in cutaneous leishmaniasis as a local injection.

In a randomized parallel groups clinical trial, patients were divided into two groups based on therapeutic regimen: 1) intralesional sodium stibogluconate weekly injection and 2) intralesional ciprofloxacin injection. Each lesion was considered a case in the final analysis. Each lesion will be followed up for 90 days (censor endpoint) or until the lesions are cured.


Eligibility Criteria:
Inclusion Criteria:

* Patients with single or multiple (less than seven lesions) lesions of cutaneous leishmaniasis

Exclusion Criteria:

* Patients who received anti-leishmaniasis treatment locally or systemically for the last month before this study
* patients on prolonged corticosteroid therapy.
The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.


Eligibility Criteria:
Inclusion Criteria:

* Females between the ages of 18- 38 years (both included) at the time of randomisation
* Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre
* Infertility for at least 1 year before randomisation (except for tubal infertility)
* A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy
* 25- 34 days of menstruation cycle
* Body mass index (BMI) \< 29 kg/m2

Exclusion Criteria:

* Any clinically significant systemic disease (e.g., insulin dependent diabetes)
* Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study
* Any concomitant medications that would interfere with evaluation of study medications. Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine's, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration.
* Presence of clinically significant uterine fibroids
* Undiagnosed vaginal bleeding
* Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
* Pregnancy, lactation or contraindication to pregnancy - must be confirmed by negative urinary pregnancy test at randomisation
Massage and Cold Water Immersion on Movement Variability After Fatigue in Swimmers

The goal of this clinical trial is to investigate the effectiveness of post-exercise massage and cold-water immersion compared to control in young elite swimmers. The main questions it aims to answer are:

* Is post-exercise techniques effective for recovery of the movement variability, , myotonometric, ergometric and perceptive parameters after fatigue?
* Can neuromuscular fatigue protocols impair movement variability, myotonometric, ergometric and perceptive parameters?
* What tests are reliable to assess different aspects of swimmers' recovery?

Researchers will compare massage and cold-water immersion to control and to each other to see if recovery is antecipated. They will also compare an in-water and an out-of-water fatigue protocol to see if they are effective and can be used in different settings.

Participants will:

* Perform test and retest sessions to assess movement variability, myotonometric, ergometric and perceptive parameters.
* Perform an in-water fatigue protocol consisting of 8x100m front-crawl sprints
* Receive three recovery strategies in a randomized order (massage, cold-water immersion and control (i.e. rest)
* Answer a questionnaire regarding ther beliefs and preferences for recovery.


Eligibility Criteria:
Inclusion Criteria:

* male and female athletes
* between 15 and 30 years old
* no injury over the last month (any complaint that prevented the athlete from training or compete at least once)

Exclusion Criteria:

* use of pain killers at least 24h before study participation
Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union

This is prospective, non-randomized, single-arm study to assess the safety and effectiveness of lowering intraocular pressure with the Beacon Aqueous Microshunt. A total of 65 subjects will be enrolled at five centers. The primary endpoint will be assessed at 12 month follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Age 22 years and older.
2. Diagnosed with mild, moderate or severe open-angle glaucoma (OAG).
3. Best corrected vision acuity 20/25 or worse in the study eye.
4. Inadequate medical control of IOP, or target IOP not reached with intraocular pressure in the study eye greater than or equal to 20 mmHg.
5. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 09:00 and 03:00 in the study eye.
6. Adequate space in the anterior chamber of the study eye sufficient to support implant with the BAM, defined as two contiguous clock hours of scleral spur visualization via gonioscopy, without compression, in the superior 180 degrees of the anterior angle.
7. Any IOP-lowering medications should be stabilized at least 30 days prior to baseline measurements.
8. Able and willing to comply with protocol requirements.
9. Able to understand and sign the Informed Consent form.

Exclusion Criteria:

1. Active Neovascular Glaucoma in the study eye.
2. Pigmentary Glaucoma in the study eye.
3. Pseudoexfoliative Glaucoma in the study eye.
4. Any eye disease associated with the formation of free-floating material or tissue in the anterior chamber of the eye.
5. Corneal conditions in the study eye that may inhibit normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of the implant inside the anterior chamber.
6. Anticipated need for ocular surgery within one year in the study eye.
7. Contact lens use in the study eye.
8. Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.
9. Other clinical conditions:

   1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c \>8.
   2. Cancer requiring treatment during the duration of the study.
   3. Any drugs (e.g.: immunosuppressive drugs) or co- morbidity that might inhibit wound healing.
10. Participation in any other clinical trial during participation in this trial.
11. Life expectancy \<1 year.
12. Clinically significant macular degeneration in the study eye.
13. Patients who have undergone surgery in the trial eye within the last 6 months.
14. Planned combined cataract surgery.

If both eyes of a prospective trial participant are eligible, the eye with the highest intraocular pressure will be selected for implant.
A Second Dose of Measles Vaccine (MV) in the Second Year of Life

This study evaluates the non-specific effects on child mortality and morbidity of a second dose of measles in the second year of life. Half of the study participants will receive a second dose of measles vaccine at 18 months of age while the other half will receive a second dose of measles by 4 years of age or at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Children need to have received the third dose of inactivated vaccines (Penta, PCV13 and IPV) before measles vaccination.

Exclusion Criteria:

* Having severe malformations that impairs their health
* Having received a second dose of measles vaccine
* Severely ill (requiring hospitalization) upon clinical examination