cyrilzakka/clinical-trials huggingface dataset:
HIV Prevention and Care of Psychological Trauma in Vulnerable Rwandan Youth

The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda.

The investigators propose a prospective single arm pilot cohort study of 100 youth (ages 15-25) to evaluate the feasibility of this project. A convenience sample of subjects will be enrolled on a voluntary basis from those who come to the day care center located in Nyanza, a district of the Southern province, in Rwanda. UYISENGA N'MANZI identified 400 youths in Nyanza region, organized in 4 groups, each of them between 160 to 100 youths. Many of those orphans go to school in any school in the country. This situation will be taken into account for the calendar of activities and for organization of the regular interviews and evaluations.

Random selection of the participant will be ensured by choosing study subjects from a list and attributing them an arbitrary number. The random selection will be weighted by the size of the household group across the 4 groups in the Nyanza region. Selection will also be in proportion of sex and age groups. In this manner 100 youth will be picked with 20 "backup" to account for refusals and drop-outs. Those selected youth will be asked to participate to the pilot study and will fill the consent form under the guidance of an external observer (not one of the service providers of the project to avoid consent obtained by social pressure).

Once enrolled, the subjects will be followed during 1 year with serial evaluations at baseline, 3, 6, 9 and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* 100 orphans/vulnerable youth aged 15 to 25 will be recruited through their participation at the day care center, on a voluntary basis.

Exclusion Criteria:

* Age less than 15 or greater than 25 and not participating in the day care center
Whole-Body 3D T1-weighted MR Imaging Anatomical Sequences: GE mDixon vs FSE (View) Approaches in Prostate Cancer.

This study will assess and compare the diagnostic performances and image quality of two WB 3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence, reducing the exam's acquisition time, patient discomfort and increasing machine availability.

Whole-body (WB) magnetic resonance (MR) imaging has increasingly been used for the screening of bone and soft-tissue metastases in patients with prostate cancer (1). A limitation for its implementation is the 45-60 minutes duration of current WB MRI examinations. Conventional WB MR imaging studies consisted of anatomical two-dimensional (2D) T1-weighted and fat-suppressed fluid-sensitive (proton-density fat-saturated (PDFS) or short-tau inversion-recovery (STIR)) and of a functional diffusion-weighted imaging sequence. Recent research has confirmed the feasibility of replacing the 2D anatomical sequences by a single three-dimensional (3D) T1-weighted fast spin echo (FSE) sequence (2).

This study will assess and compare the diagnostic performances and image quality of two WB 3D T1-weighted MR imaging sequences for bone and node staging in patients with prostate cancer : the FSE sequence and a gradient echo (GE) sequence. The latter sequence's main feature is its acquisition time of approximately 1.5 minutes, compared to 18 min for the FSE sequence, reducing the exam's acquisition time, patient discomfort and increasing machine availability.

The aim of this study is to evaluate the feasibility of the replacement of the WB 3D T1-weighted FSE MR imaging sequence by the WB 3D T1-weighted GE MR imaging sequence.

Eligibility Criteria:
Inclusion Criteria:

* prostate cancer with high risk for metastases

Exclusion Criteria:

* contraindications to MRI
Feasibility of Visual Field Screening Apps

A visual field (VF) is a measurement of how wide an area our eyes can see when fixed onto a point. Visual field testing is one of the ways of assessing how much vision there is in each eye and how much vision might have been lost over time. Defects in the visual field are seen in diseases such as glaucoma, which is one of the leading causes of blindness. VF tests should be performed regularly during outpatient appointments to help monitor these conditions before they progress. Monitoring individuals with VF defects presents a large strain on eye services at University Hospitals Southampton (UHS).

Recently an Apple iPad-based application called 'VisualFields easy' has been developed that could be used at home to test visual fields, opening up the possibility of remote monitoring. This is especially significant since the onset of the COVID-19 pandemic which has left outpatient clinics across the UK with large patient backlogs. However, it's not understood yet to what level of accuracy this iPad test can be performed by untrained people and whether the results of this test are medically reliable.

This study will measure if there's a correlation between iPad-based VF measurements and the standard clinic-based measurements taken by professionals. The potential of this app to be used at home will also be assessed with a usability questionnaire. These measurements will be taken during routine eye and neurology outpatient clinics at UHS. Home-based VF testing could allow those who weren't able to access eye services during the pandemic greater follow-up and monitoring. Through providing regular, up-to-date information on a patient's condition and progress, VF tests at home may improve outcomes. The investigators also foresee the benefits of this app on NHS clinical services, with the potential of reduced outpatient appointments and waiting times thus easing pressure on the NHS.


Eligibility Criteria:
Inclusion Criteria:

* Participant aged 17 or older
* Familiar with and able to use tablet technology

Exclusion Criteria:

* Patient not willing to participate in the study and give written informed consent
* Patients with learning difficulties that preclude reliable assessment of visual fields
Diet and Body Composition

The investigators hypothesize that differential dynamics in fat depots in response to two opposing dietary strategies mediate the beneficial metabolic effects during weight loss and regain phases.


Eligibility Criteria:
Inclusion Criteria:

* Elevated waist circumference:

  * Men: \> 40 inches (102 cm)
  * Women\> 35 inches (88 cm)
* Poor dieters with TG\>150mg/dL and high-density-lipoprotein cholesterol \[HDL-c\] \<40 mg/dL for men and \<50 mg/dL for women

Exclusion Criteria:

* Pregnant or lactating women
* Serum creatinine LT 2 mg/dl
* Disturbed liver function (LT 3 fold level of ALT and AST enzymes)
* Active cancer
* Individuals who cannot start physical activity in the gym
* Individuals that are highly physically active (more than 4 hours/week)
* Active in other nutritional trial
Interest of Tissue Oxygen Pressure (PtiO2) Monitoring to Detect a Vasospasm Post Aneurysmal Subarachnoid Hemorrhage

Vasospasm is a current complication after aneurysmal subarachnoid hemorrhage and often and often associated with brain ischemia. This complication is difficult to detect, because clinical examination is hardly helpful in sedated patients and the performances of transcranial doppler can only detect the spasm of middle cerebral arteries.

Tissue Oxygen Pressure (PtiO2) Monitoring allows early detection of brain oxygenation local modifications and of brain ischemia, via continuous monitoring.

This study aims to assess the performance of the tissue oxygen pressure monitoring in detecting a vasospasm post aneurysmal subarachnoid hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* severe aneurysmal subarachnoid hemorrhage
* patient sedated
* patient hospitalized in intensive care unit between January 2013 and August 2015
* multimodal neurologic monitoring including Tissue Oxygen Pressure and transcranial doppler

Exclusion Criteria:

* insonation impossible
Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy

1. To assess the clinical and neurophysiological efficacy of Xeomin® vs. Botox® in children with spastic equine and equinovarus foot deformation in pediatric cerebral palsy
2. To assess the safety of Xeomin® use as compared to Botox® in this patient population


Eligibility Criteria:
Inclusion Criteria:

* Children from 2 through 12 years of age, of both sexes, suffering from spastic paraplegia or hemiparesis in pediatric cerebral palsy.
* Equine and equinovarus foot posture.
* Gastrocnemius spasticity of 2 points and greater, by modified Ashworth scale.
* Patient can walk unassisted or with a support.
* Mental development of patients is normal or mildly retarded.
* Previous course of spasticity treatment with BTA products was completed earlier than at 6 months before this trial or never administered before.
* Patient's parents have signed an informed consent, are able and wishing to adhere to procedures described in the trial protocol and to the schedule of visits throughout the entire period of treatment.

Exclusion Criteria:

* Fixed ankle joint contracture.
* Previous denervation of spastic muscles by surgery, phenol or alcohol;
* Athetosis and dystonia in the area of injected muscles.
* Inflammation at the planned injection site.
* Elevated body temperature and acute (infectious and non-infectious) diseases at the time of injection.
* Neuromuscular transmission disorders (myasthenia gravis, Lambert-Eaton syndrome, etc.).
* Decompensated physical diseases potentially affecting the trial findings.
* Acute fever, infection or surgery within 1 month before the trial.
* Use of aminoglycosides or spectinomycin within 1 month before starting the trial.
* Hypersensitivity to any of product ingredients.
* Positive history for allergies (especially with regard to protein-containing products).
* Patient's parents are unable or unwilling to adhere to the trial protocol requirements including signing the informed consent and conforming to the schedule of visits.
* Participation in other clinical trials in the last 4 weeks before inclusion.
Efficacy of Maraviroc in Modulating Atherosclerosis in HIV Patients.

The investigator tested the efficacy of maraviroc intensification on down-regulating atherosclerotic progression in HIV infected patients with optimal viro-immunologic control and at high cardiovascular risk.

Experimental CCR5 antagonism with maraviroc in atherosclerosis-prone mice and preliminary data in humans suggest an anti-atherosclerotic effect of the drug. The investigators assessed the impact of maraviroc treatment in HIV-infected patients on several subclinical indicators of atherosclerosis and putative mechanisms for such an effect.

HIV-treated patients under effective antiretroviral (ART) therapy, with a Framingham risk score \>20% and a brachial flow-mediated dilation (bFMD) \<4%, as indices of high cardiovascular risk, were recruited. Maraviroc (300 mg per os for 24 weeks) was administered on top of ART to all participants using a cross-over design. Brachial FMD, carotid-femoral pulse wave velocity (cfPWV) and carotid intima-media thickness (cIMT) were measured as non-invasive markers of atherosclerosis. Vascular competence, as expressed by the ratio of circulating endothelial micro-particles (EMPs) to endothelial progenitor cells (EPCs), as well as markers of systemic inflammation, monocyte activation and platelet activation were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients were consecutive ≥50-year-old individuals, treated for over 1 year with an effective protease inhibitor ART regimen (HIV RNA \<50 copies/mL), with CD4 T cell counts \> 300/ mm3 for at least 6 months and a Framingham risk score \>20% and bFMD \<4%.

Exclusion Criteria:

* Patients over 70 years of age, with life expectancy \< 12 months, with known platelets functional defects or alcohol chronic abuse were excluded.
NeuroCognitive Communicator: Safety Study

Individuals suffering from tetraplegia as a result of cervical spinal cord injury, brainstem stroke, or amyotrophic lateral sclerosis (ALS) cannot independently perform tasks of daily living. In many cases, these conditions do not have effective therapies and the only intervention is the provision of assistive devices to increase independence and quality of life. However, currently available devices suffer from usability issues and are limiting for both the patient and caregiver. One of the most progressive alternative strategies for assistive devices is the use of brain-computer interface (BCI) technology to translate intention signals directly from sensors in the brain into computer or device action. Preclinical primate research and recent human clinical pilot studies have demonstrated success in restoring function to disabled individuals using sensors implanted directly in motor regions of the brain. Other preclinical primate research has demonstrated effective intention translation from sensors implemented in cognitive regions of the brain and that this information complements information from the motor regions. The current proposal seeks to build on these studies and to test the safety aspects related to implanting two sensors, each a microelectrode array, into both the motor and cognitive regions of the brain in motor impaired humans. Secondary objectives include feasibility evaluation of the complementary sensors in their ability to support effective assistive communication.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of a complete or incomplete cervical spinal cord injury, with stable neurological deficits greater than 1 year, or ALS with equivalent degree of deficit.
* Maintain some level of communication, enough to independently provide informed consent for the study.
* Deemed healthy for surgery.
* Good psychological and social stability.
* Prospective participants with ALS must already have an advanced directive with regard to ventilation.
* Live within a one-hour travel duration of the site.

Exclusion Criteria:

* Presence of previous certain implanted devices.
* In the opinion of the investigator, the presence of other serious disease or disorder that could affect ability to participate in this study.
* Ongoing participation in another clinical trial.
* Individuals who are immunosuppressed or who have conditions that typically result in immunocompromise (eg. chronic corticosteroid use, immunomodulators, chemotherapy).
* Presence of clinical depression that is not medically optimized, as screened by a neuropsychologist on our team.
* Presence of cognitive deficits, as assessed by a neuropsychologist on our team, that would preclude completion of some cognitively challenging tasks.
* The participant has plans to move outside the study radius within the study period.
Weight Loss on the Web: A Pilot Study Comparing a Commercial Website to a Structured Behavioral Intervention

The primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. The investigators hypothesized that there would be no difference in weight loss between groups.

Obesity has reached epidemic proportions in the United States. Novel approaches are needed to address this issue on a broad scale. The internet holds promise as a way to disseminate effective weight loss strategies. The primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. A second aim was to evaluate the utilization of web components and their relationship to weight loss between groups and within groups in order to determine what aspects of web usage correlate to weight loss.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 39.9 kg/m2
* 18 or older

Exclusion Criteria:

* Planned to move within 1 year
* Planned a pregnancy within 1 year
* Take medications with weight implications
* Unable to exercise moderately
* Participating in another weight loss program
* Lacked minimum computer requirements
UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.

Patients eligible to be treated on this status are status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).

Eligibility Criteria:
Inclusion Criteria:

1. AML in morphologic remission with intermediate/high-risk features or relapsed disease 1 or 2
2. ALL in morphologic remission with high-risk features or relapsed disease 1 or 2
3. Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
4. Myelodysplastic syndromes with \<=10% blasts
5. CML in morphologic remission after blast phase or accelerated phase
6. Primary myelofibrosis with \<=10% blasts \^morphologic remission is defined as \<5% blasts on the bone marrow biopsy. Negative test for donor-specific antibody within 28 days of starting conditioning regimen, or adequate for standard desensitization protocol.

Exclusion Criteria:

1. Non-compliant patients.
2. No appropriate caregivers identified.
3. Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
4. Patients with known allergy to DMSO.
5. Pregnant or breastfeeding women
Open-Label Duloxetine Extension Phase in Patients Who Have Completed Previous Duloxetine Trials

A study in patients with depression


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at least 18 years of age who have previously completed satisfactorily the Lilly sponsored previous clinical trial, and who are clinically controlled with Duloxetine, as judge by the investigator
* All females must test negative for a urine pregnancy test at Visit 1. Females of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopausal) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study. Women who are pregnant or breast-feeding may not participate in the study.
* Must sign the informed consent document (ICD).

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug ( not including study drug) that has not received regulatory approval for any indication at the time of study entry.
* Patients who have entered the optional tapering period of the previous study.
* In the opinion of the investigator, patients judged to be at serious suicidal risk.
* Treatment with a MAOI within 14 days prior to Visit 1 or potential need to use MAOI during the study or within 5 days of discontinuation of the study drug.
* Any patient who previously experienced a serious adverse event while taking duloxetine unless approved by the Lilly Physician
Effects of Ba Duan Jin Training for Older People

Baduanjin is one of the widely circulated fitness methods. The Ministry of Health, the Ministry of Education and the General Administration of Sports of China have vigorously promoted it as one of the contents of health and physical education classes, and promoted it as a health Qigong method throughout mainland China. It can be seen that Baduanjin's gentle and non-aggressive movements are suitable for physical training for people of all ages.


Eligibility Criteria:
Inclusion Criteria:

* (1) old person able to communicate and follow instructions, (2) stable and with sufficient physical strength: able to maintain at least one sitting position in a wheelchair or on the edge of a bed.

Exclusion Criteria:

* (1) Difficulty standing or walking and obvious musculoskeletal disease, (2) Diagnosed and recommended by a physician Those who are not suitable for sports activities, (3) serious diseases/unstable conditions, such as severe cardiopulmonary, liver and kidney diseases, severe malignant tumors, severe malnutrition, severe dementia, (4) more than 180 minutes of exercise per week in the past month time, (5) severe arrhythmia, (6) no intention to participate.
Screening for Pulmonary Vascular Changes in Patients With Chronic Myeloproliferative Diseases

Goal of the study is to assess the frequency of pulmonary hypertension in patients with chronic myeloproliferative diseases. In each patient an echocardiography at rest will be performed. In patients without musculoskeletal disease an exercise test (spiroergometry) will be performed. Patients with elevated SPAP at rest or with reduced exercise capacity (peak VO2 \< 65%) a right heart catheterization (RHC) will be recommended. Also patients with advanced NYHA functional class (III or IV) or with typical PH findings in electrocardiogram will be advised to undergo a RHC. Additionally for the evaluation of exercise capacity a 6 MWD will be performed.

This work- up of patients allows clinical and hemodynamic evaluation.

Previous small studies and clinical cases have suggested a possible association between pulmonary hypertension (PH) and chronic myeloproliferative disorders (CMPD). MPD may cause PH through different mechanisms as: high cardiac output, asplenia, direct obstruction of pulmonary arteries by megakaryocytes, chronic thromboembolic endothelial pulmonary hypertension (CTEPH), porto-pulmonary hypertension (POPH). However, the exact prevalence of PH in this group of disorders is not known.

This study is designed to identify the pulmonary vascular changes and describe the prevalence of pulmonary hypertension (defined in this study as mean pulmonary arterial hypertension (mPAP) ≥25mmHg as assessed by right-heart catheterization (RHC) or systolic pulmonary arterial pressure (sPAP) ≥37mmHg (2.9 m/s) assessed by echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Patients with myeloproliferative disorders
* Written informed consent

Exclusion Criteria:

* Manifest pulmonary hypertension
* Significant pulmonary disease
* Left-sided heart failure or diastolic compliance dysfunction
* Hemodynamic relevant valvular disease
* Systemic arterial hypertension (at rest systolic \>150 mmHg, diastolic \> 90 mmHg, during exercise \> 220 mmHg)
* Severe anemia
* Uncontrolled supraventricular and ventricular arrhythmias
* Myocardial infarction (within the last 12 months)
* Pulmonary embolism (within the last 12 months)
* Recent therapy changes (within the last 12 months)
* Recent major surgeries (within the last 12 months)
* For exercise tests: musculoskeletal diseases which may unable the exercise tests