cyrilzakka/clinical-trials huggingface dataset:
Effects of an Individualized Training Program on Severity Markers of Obstructives Sleep Apnea/Hypopnea Syndrome (OSAS)

There are two types of treatments depending on the severity of Obstructive Sleep Apnea/Hypopnea Syndrome (OSAS): - for the treatment of severe (AHI\> 30/h), the standard treatment is Continuous Positive Airway Pressure (CPAP). If it proved effective in reducing excessive daytime sleepiness and associated cardiovascular risk, compliance of patients 4 years of treatment falls below 70%. - Treatment of moderate (AHI between 15 and 30/h), lifestyle measures, the bracing of mandibular advancement and / or possibly the head and neck surgery can be proposed. These treatments include side effects and their effectiveness is very controversial.Il therefore seemed interesting to test the impact of physical activity through a standardized training program to re personal effort on the development and improvement of OSAS patients with a sedentary moderate to severe OSAS (AHI between 15 and 40 / h) The main assumption is that the ESR could eventually delay the initiation of treatment with CPAP in severe OSAS or an alternative therapeutic relevance in the moderate OSAS and severe in patients who can not tolerate conventional treatment(CSF). The main objective of this biomedical research is to evaluate the effects of a program of REE in ambulatory index of hourly apneas / hypopneas (AHI = marker of severity of OSAS) .- objectives specify 2AIR effects of REE on the quality of sleep (TxSLP) and daytime symptoms (EDS objective fatigue) on the one hand and the other on the metabolism (OV, SM, IR) and markers of LCR (inflammation, oxidative stress , endothelial function).


Eligibility Criteria:
Inclusion Criteria:

* Presence of an OSAS
* Apnea Hypopnea Index between 15 and 45/h
* Sedentary subjects (Voorips Activity questionnaire)
* IMC\<40
Family Participation in CICU Rounds: RCT

This is a single-center, unblinded, pragmatic randomized controlled trial comparing family participation in cardiac ICU team rounds with usual care. We will recruit 112 family members. The primary outcome will be family member care satisfaction. Secondary outcomes will include family mental health and care engagement. The beliefs, attitudes, and knowledge of healthcare providers, including medical trainees, about family participation in rounds will be evaluated prior to and following the intervention.

This is a single-center (Jewish General Hospital), unblinded, pragmatic randomized controlled trial comparing family participation in the Cardiac Intensive Care Unit (CICU) team rounds with usual care.

Research team will recruit family members and health care providers in the Cardiac Intensive Care Unit (CICU) at the Jewish General Hospital. Family members will be randomized in a 1:1 ratio to either the intervention or usual care using the REDCap randomization module. The intervention consists of family invitation and participation in team rounds during the patient's stay in the CICU. Family may participate in-person or virtually. Usual care consists of interdisciplinary team rounds that occur outside the patient's room each morning without family presence.

A research team member will approach the participating family member to distribute the follow-up survey after transfer of the patient to the cardiovascular ward or prior to hospital discharge if the patient will be discharged from the hospital directly from the CICU. The follow-up survey will be composed of the FS-ICU, HADS, and FAME surveys. The perspectives of healthcare providers, including medical trainees, prior to and after the intervention will be assessed through the QFIFE survey.

An increase in the mean family care satisfaction score, as measured by the Family Satisfaction in the ICU survey (FS-ICU) is hypothesized for family members participating in team rounds. A positive change in attitudes and knowledge of healthcare providers and medical trainees following family participation in rounding is also expected.

The proposed study will generate much needed evidence for the effectiveness of a family rounding strategy to improve family-centered outcomes in the cardiac ICU. The evidence derived from this study could support the practice of family participation in team rounding and inform clinicians about the potential benefits of this approach.

Eligibility Criteria:
Inclusion Criteria:

* expected patient length of stay \>48 hours
* family member, as designated by the patient or surrogate decision maker
* able to participate in English or French
* willingness to participate in morning rounds

Exclusion Criteria:

* another family member has already participated in the study
* inability to provide informed consent in English or French
Pioglitazone on Cardiac Function and Large Arteries (PICCOLA Study)

This study aims to use a novel, sensitive, non-invasive scanning technique to investigate the effects of insulin-sensitizing agent pioglitazone, on heart and artery function.

The prevalence of diabetes mellitus and impaired glucose tolerance are nearing epidemic proportions in developed societies. For example in the USA \>16 million individuals have diabetes and this number is predicted to double over the next two decades. Diabetes is a major risk factor for death and disability, primarily from cardiovascular disease (CVD).

The mechanisms of how diabetes increases the risk of developing CVD are not fully understood. It is evident from previous studies that diabetes has an adverse effect on both artery and heart function. What is emerging from recent studies is that it is likely that these proven dysfunctions in the arteries and heart interact to increase the risk of CVD.

Insulin-sensitizing agents, such as Pioglitazone, may have a beneficial effect on heart and artery function. This study aims to further our understanding of the effect of these agents on heart and artery using a novel, sensitive, non-invasive scanning technique to investigate the effects of this group of drugs on heart and artery function.

This is a prospective double-blind randomised crossover study comparing the insulin-sensitizing drug, Pioglitazone with a placebo in 24 volunteers. Following a \>1 week run-in period subjects will be randomised double-blind to 1 of 2 treatment sequences. Subjects will either receive the active drug (Pioglitazone 45mg/day) for a 12 week period, followed by a 2 week washout and then the placebo drug for 12 weeks OR they will receive the placebo drug for 12 weeks, followed by the 2 week washout and 12 weeks of the active drug (Pioglitazone 45mg/day).

This design was chosen to test the null hypothesis that the active drug will have no effect on diastolic heart function. The use of a placebo is essential to ensure that any benefits found can be attributed to the active drug. The design also allows us to minimise the number of subjects needed and is the gold standard approach to avoid observer bias.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any age with Type 2 Diabetes

Exclusion Criteria:

* Subjects will be excluded if they have any of the following:

  * Known coronary heart disease,
  * Patients receiving Insulin,
  * Uncontrolled hypertension (i.e. \>160mmHg systolic or \>95mmHg diastolic),
  * Systolic dysfunction (ejection fraction \<50%),
  * Heart Valve Disease,
  * Proliferative or pre-proliferative retinopathy,
  * Severe hepatic or renal impairment.
  * Possible pregnancy
  * Malignancy
Study Comparing Negative Pressure Dressing vs Conventional in Patients With Resected STS After Radiotherapy

This is a randomized (1:1 ratio), prospective, comparative, controlled, open-label study. The aim is to compare the efficacy of negative pressure therapy (PREVENA™) versus standard postoperative wound management on the wound healing after surgery for previously irradiated Soft Tissue Sarcoma (STS)

The gold standard treatment for primary non-metastatic STS is complete surgical resection. Peri-operative Radiation Therapy (RT) has been proved to improve local control . Nevertheless, the timing of RT, whether preoperative or postoperative, remains a debate.

Both have similar local control efficacy, but preoperative RT results in lower rates of long-term fibrosis and lymphedema and improved joint mobility than postoperative RT. On the other hand, the adverse effect of pre-operative RT is a higher rate of wound post-operative complications and re-operations.

Any effort to reduce the high rate of postoperative complications could offer the advantage of preoperative RT in terms of reduced long-term sequelae compared with postoperative RT without a higher wound complication rate postoperatively. Short retrospective series of Negative Pressure Wound Therapy (NPWT) after surgical resection of Soft Tissue Sarcoma (STS) have reported very encouraging results in preventing wound complications: patients treated with NPWT were less likely to develop wound complications than those who did not receive it. Both groups did not report an increased rate of local recurrence. The use of NPWT would also reduce the cost of care by avoiding complications.

That's why the investigators propose this study comparing the use of a negative pressure dressing to a conventional dressing in patients with STS of the limbs or trunk resected after neo-adjuvant external radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years at the day of consenting to the study
* Patients with primary STS of the limb or trunk treated with preoperative external radiation therapy (decided in multidisciplinary board)
* Intent to cure resection required for STS planned between 3 to 8 weeks after the end of RT
* Planned primary wound closure, including local or distant jambeau
* Ability to understand and willingness for follow-up visits
* Covered by a medical insurance
* Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.

Exclusion Criteria:

* Known hypersensibility to silver
* Patients with a diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor
* Planned no wound-closure and skin graft after resection
* Patient requiring authorship or curators or patient deprived of liberty.
A Multidisciplinary Telerehabilitation for Stroke Patients

Objective: Evaluate the feasibility of a multidisciplinary telerehabilitation for chronic stroke patients.

Design: Chronic stroke patients eligible for multidisciplinary rehabilitation funded by the Social Insurance Institution were enrolled between September 2017 and March 2018 in a consecutive basis to receive a mixed program of inpatient rehabilitation and telerehabilitation in their homes or a traditional inpatient rehabilitation only.

Intervention: A rehabilitation course with a 3-day inpatient stay followed by an 8-week telerehabilitation period completed by 2-day evaluation stay in a rehab center. The control group received conventional multidisciplinary rehabilitation for two weeks in an inpatient setting.

Outcome and measures: Change in the Finnish version of Functional Status Questionnaire (FSQFin), the World Health Organization Quality of Life - Short version (WHOQOL-Bref), the Barthel Index, the Beck Depression Inventory (BDI21), and the Goal Attainment Scale (GAS) and a patient satisfaction questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* chronic stroke (6 months or more) patient living in home
* eligible to receive rehabilitation funded by the Social Insurance Institution (meets the criteria of chronic disability and need for rehabilitation)
* for intervention group: capable to use a personal computer and telecommunication

Exclusion Criteria:

* no access or capability to use a personal computer
* significant problems in hearing, seeing or understanding information related to the intervention
Evaluation of the Risk Associated With Impulsivity and Other Neuropsychological Factors on Suicidal Relapse Within Hospital Emergencies

Suicidal behavior (SB) is a major public health problem in France, with over 10,000 suicides (6th in the EU28) and 220,000 suicide attempts (SA) per year. These data seem underestimated by 20%. A large percentage of men (6%) and women (9%) in France made at least one lifetime SA. In addition, SBs are common among young people and are the second leading cause of death among 15-44 year-olds. The interaction of multiple factors in SB complicates the creation of predictive models. These are currently imprecise and prevent the development of consensual recommendations for the management of suicidal patients.

Most suicide attempters are evaluated in the emergency room where it is imperative to identify people with a high risk of relapse. Risk assessment is generally based on the experience of the practitioner who uses psychometric scales as support for clinical decisions. This assessment could be improved and supplemented by other sources of information. Thus, we aim to develop a short and specific tool that combines:

1. Neurocognitive measures carried out using computer software on domains strongly associated with SB: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention and verbal fluency.
2. Clinical and psychological assessment including the most predictive items of future SA: life events (environment) and personality traits (vulnerability). Suicide attempters will be assessed for SB and suicidal ideation in the emergency department. These measures will be repeated during a 12-month follow-up. We will use the data obtained to provide a more accurate measure of risk.

Over 65 months, 5 emergency departments (Montpellier, Nimes, Uzès, Nice, Marseille) will recruit a total of 650 patients who attempted suicide.

* First visit: clinical and neuropsychological assessment
* Second and third visits at 6 and 12 months: assessment of SBs and suicidal relapse, clinical and neuropsychological assessment.

Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old
* Have committed a suicide attempt within 7 days prior to inclusion
* Receive minimal treatment (assessed by the clinician)
* Sign the informed consent
* Be able to understand the nature, the aims and the methodology of the study

Exclusion Criteria:

* Patient with an actual or past history of psychotic disorder
* Patient not affiliated to a French social security system.
* Patient deprived of liberty (judicial or administrative decision)
* Patient aged 65 years or older with an MMSE score \<24 at baseline.
* Patient in exclusion period after participation in another project
* Patient who has already achieved 4500€ of annual research allowances
Safety Evaluation Study for Patients With Polycythemia Vera

This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PV according to either the 2008 or 2016 WHO classification criteria
* PV patients being only treated with phlebotomy and the interval is 4-9 weeks

Exclusion Criteria:

* Patients administrated drugs for PV treatment such as hydroxyurea or ruxolitinib (aspirin is excluded)
Effects Of Bobath Exercises Combined With Gasotransmitter On Spastic Diplegic CP

This study examines the effects of combining Bo bath neurodevelopmental exercises with gasotransmitter in children with spastic diplegic cerebral palsy, a condition marked by muscle stiffness and coordination challenges in the legs.

The primary objective is to enhance motor learning by reinforcing weak movement patterns while reducing excessive muscle activity. Additionally, this combination aims to improve postural control, movement coordination, and overall functional abilities.The randomized controlled trial includes 47 children aged 6-18, divided into three groups: one receiving only Bo bath exercises, another receiving gasotransmitter alone, and a third receiving both interventions. Baseline assessments were conducted, and ethical approval along with informed consent was obtained. The interventions target spasticity reduction and gross motor improvement, with outcomes measured using the Gross Motor Function Classification System (GMFCS) for motor skills and the Modified Ashworth Scale for spasticity. Findings suggest that combining Bo bath therapy with gasotransmitters effectively reduces spasticity, enhances motor control, and supports activities of daily living, highlighting its potential as an effective therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:

* A Confirmed diagnosis of spastic diplegic cerebral palsy
* Participants aged 6 to 18 years.
* Moderate to severe spasticity in the lower limbs, as measured by the Modified Ashworth Scale.
* Ability to follow simple instructions and participate in the stretching exercises.
* Written informed consent obtained from the participant's legal guardian or the participant if of legal consenting age.
* No significant changes in medication or therapy for cerebral palsy in the three months prior to the study.

Exclusion Criteria:

* Presence of other neurological conditions apart from spastic diplegic cerebral palsy.
* History of major orthopaedic surgery in the past year or planned surgery during the study period.
* Receipt of botulinum toxin injections in the lower limbs within the last six months.
* Severe joint contractures that limit the range of motion necessary for the stretching exercises.
* Any medical condition that contraindicates participation in the study, such as uncontrolled epilepsy, severe cardiovascular disorders, or acute infections.
* Inability or unwillingness to comply with the study protocol and scheduled visits.
A Study to Evaluate Flexible Dose of Paliperidone Extended Release (ER) and Clinical Response in Participants With Schizophrenia

The purpose of this study is to evaluate the effectiveness of paliperidone ER for the treatment of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.

This is a multi-center (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), prospective (study following participants forward in time), non-comparative study. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 2, 4, 8, and 12 (end of treatment or early withdrawal). The effectiveness of paliperidone ER will be evaluated at Week 12 by the proportion of responders who are evaluated as "very much improved" or "much improved" on the Clinical Global Impression improvement (CGI-I) Scale. Participants' safety will also be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are diagnosed with schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders \[Edition 4\] criteria)
* Participants with Clinical Global Impression-Severity (CGI-S) score greater than or equal to 4 points (moderately ill) at Screening
* Childbearing potential women who consented to the consistent use of the acceptable contraception (oral contraceptive, contraceptive injection, intrauterine device, double barrier method and contraceptive patch)
* Participants who are capable of and willing to fill out the questionnaire for themselves
* Participants who are compliant with self-medication or can receive consistent help or support

Exclusion Criteria:

* Participants with the past history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
* Participants with allergy or hypersensitivity to risperidone or paliperidone
* Participants who have taken clozapine, or have been exposed to the study drug within one month before screening
* Participants who have been treated with the long acting antipsychotic injection within 28 days
* Participants with significant risk including suicide or aggressive behavior
A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma

The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.


Eligibility Criteria:
Inclusion Criteria:

* Must have been diagnosed with either Stage IIIA (\> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
* Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and \< 18 years of age must have a Lansky/Karnofsky performance score ≥ 80%
* Complete resection must be performed within 90 days prior to randomization
* All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
* Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

* History of ocular melanoma
* Untreated/unresected CNS metastases or leptomeningeal metastases
* Active, known, or suspected autoimmune disease
* Participants with serious or uncontrolled medical disorder
* Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
* Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
* History of myocarditis, regardless of etiology.

Other protocol-defined inclusion/exclusion criteria apply
Urine and Stool Analysis in Kidney Stone Disease

The purpose of this study is to add to the investigators' quest to understanding stone disease, by evaluating the metabolites excretion in urine and its relation to microflora present in the stool.

Kidney stones affect up to 10% of the Canadian population and can lead to pain, hospitalization, lost of time at work, and surgery. Approximately 80% of stones consist of calcium and oxalate, of which both components come from diet and normal bodily processes. Individuals who have high levels of oxalate in their urine have a greater tendency to generate stones. One recommendation is to reduce their intake of oxalate-containing foods, but many healthy foods contain oxalate, and an oxalate-free diet is unpalatable and difficult to achieve. Some patients, despite reducing their oxalate intake, still have high amounts in the urine.

Intestinal metabolism is largely affected by the state and composition of the intestinal bacterial flora, with several metabolic diseases being linked to a disrupted "normal" intestinal flora. The investigators believe that calcium oxalate stone disease as well as high urinary levels of oxalate (hyperoxaluria) are triggered by inefficient oxalate metabolism in the intestine, which is linked to a "disrupted" intestinal bacterial flora that lacks certain key components such as O. formigenes. The long-term purpose of this study is therefore, to determine the effect of replenishing the intestinal flora of patients with that of "normal" controls, thereby re-introducing a balanced environment that will lead to the re-establishment of normal metabolic functions and a decrease in urinary oxalate levels and hopefully lower incidence of stone disease.

Eligibility Criteria:
Inclusion Criteria:

Controls

* Age \> 19.
* No history of kidney stone disease

Study Patient (Stone Patient)

* Age \> 19
* Radiological evidence indicating presence of a current renal or ureteric stone

Exclusion Criteria:

* Pregnancy
* Positive Urine Culture
* Active cancer
* Recurrent urinary infections
* Gross hematuria
* Inability to provide informed consent
* In the Investigator's opinion, the patient would not be good for the study.

Controls Only:

* Family history of kidney stones
* History of kidney stones