cyrilzakka/clinical-trials huggingface dataset:
Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD) Device

The main purpose is to study, in comparison to classic Home Nursing Care Services (SSIAD), the effect of reinforced Home Nursing Care Services (SSIAD) on the occurrence of hospitalizations

It's a non-interventional, multi-centred, controlled study.

Inclusions will start with patients benefit from a so-called "reinforced" bed in the experimental Home Nursing Care Services (SSIAD), that is, with a score between 11 and 21 on the regional public health authorities (ARS) score. Patients from the classic Home Nursing Care Services SSIAD (control arm) will be inclused on a matching mode to the individual clinical profiles of patients recruited into the reinforced Home Nursing Care Services (SSIAD). Matching will be based on age, sex, and comorbidity score (Charlson scale). Screening for matching will be done by a geriatric physician appointed by the sponsor. Once screened in, patients will be proposed the study by the Home Nursing Care Services SSIAD lead investigator who provides home care. Patients in the control arm will also express no opposition. For each patient accepting the study, their family caregiver - if there is one - will also be proposed the study. Various data: Prescription medicinal, reason and duration of hospitalization, number and reason for emergency department presentations, independence and dependency scores and other scales will be collected retrospectively, at inlcusion (J0) , then monthly (M1 to M12).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 60 years old
* Having obtained a place in SSIAD by medical prescription
* Able to understand and respond to study questionnaires and evaluations with or without the Assistance of a third party
* Resident in territories of activities of the SSIAD participating in assessment
* With social coverage
* Having expressed non-oppostion to his participation in study and documented in his medical file
* Only for patients in " einforced SSIAD ": patient with a so-called "reinforced" bed financed by " Regional Public Health authorities " (ARS) of Ile-de-France, and with a score between 11 and 21 on the ARS score

Exclusion Criteria:

* Age \< 60 years old
* Expressing his opposition to participate in the study
* Not resident in the territory of activity of SSIAD
* Requires only technical care and management in the act
* Unable to understand and respond to study questionnaires and evaluations, even with third party assistance
Coblation Versus Suction Diathermy in Pediatric Adenoidectomy

The goal of this clinical trial is to compare two surgical procedures in endoscopic adenoidectomy including Coblation and Suction diathermy

. The main questions it aims to answer are: Does the Coblation device have less time, less pain, less postoperative crustation and bad odor, less intraoperative bleeding, and less recurrence?

Participants will:

will undergo both procedures every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms


Eligibility Criteria:
Inclusion Criteria:

* all patients aged 2 to 18 years
* patients who had isolated adenoid hypertrophy
* patients' hemoglobin levels above 10 mg/dl

Exclusion Criteria:

* those with recent upper respiratory tract infections, evidence of bleeding disorders, serous otitis media, chronic tonsillitis
* those advised against undergoing adenoidectomy after consulting a phoniatrist
* patients with atrophic rhinitis those with nasal obstruction caused by other nasal or paranasal conditions such as inferior turbinate hypertrophy, Choanal atresia, deviated nasal septum, antrochoanal polyps, and other causes of nasal obstruction in children.
Serum Sample Collection to Determine Analytical Performance Characteristics of the ADVIA Centaur PAPPA and BhCG Assays

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Blood samples are to be collected from pregnant women attending their scheduled 1st Trimester scan; the samples are to be collected immediately after the subject's routine blood sample at the clinic visit. No extra venepuncture will be required.

Blood samples collected will be shipped to the sponsor's laboratory to establish analytical performance characteristics of the ADVIA Centaur® Pregnancy Associated Plasma Protein A (PAPP-A) and ADVIA Centaur® Free Beta Human Chorionic Gonadotropin (Free βhCG) assays.

Eligibility Criteria:
Inclusion Criteria:

* A subject is considered eligible for participation in the trial if all of the following inclusion criteria are satisfied prior to enrolment:

  1. Subject is ≥ 18 years of age
  2. Subject is informed and has been given ample time and opportunity to think about her participation and has given her written informed consent.
  3. Women with a structurally normal viable pregnancy with a fetal crown rump length of 45-84 mm

Exclusion Criteria:

* A subject is not eligible for participation in the trial if any of the following exclusion criteria are met prior to enrolment:

  1. Subject is unable to give consent
  2. Subject has already participated in the study
Sleep Apnea and Fetal Growth Restriction

This study aims to evaluate the association between obstructive sleep apnea (OSA) and fetal growth restriction (FGR) and to assess the role of auto-titrated positive airway pressure (aPAP) as antenatal therapy in these patients. Pregnant patients with diagnosed FGR will be screened for OSA first by screening questionnaire and then by home sleep monitor. Of those patients diagnosed with OSA, half will be assigned to use aPAP each night when sleeping and half will not (standard care).

Fetal growth restriction (FGR) affects 5-10% of pregnancies and is one of the leading causes of perinatal morbidity and mortality.

Obstructive sleep apnea (OSA) is a common disorder in which a person's breathing pauses or becomes shallow during sleep. These periods of low oxygen lead stress and inflammation which that may be harmful to both the mother and her fetus. OSA in pregnancy has been associated with poor maternal-fetal outcomes, including low birth weight, preterm delivery, FGR, gestational hypertension/preeclampsia, gestational diabetes and higher rates of neonatal ICU admission.

Auto-titrated positive airway pressure (aPAP) is a machine that gently delivers pressurized air via a mask to keep a patient's airways free of obstruction during sleep. It is currently unclear whether treatment of OSA during pregnancy in women with known FGR can improve fetal and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 50
* Fetal growth restriction (defined as fetal weight \<10th percentile based on at least one routine 2nd trimester ultrasound without a subsequent increase to \>15th percentile on any ultrasounds prior to enrollment)
* Lower limit of gestational age at enrollment 22+0 weeks.
* Upper limit of gestational age at enrollment: adequate time to complete Stages 1 and 2 and if appropriate to be randomized and receive intervention by no later than 32+0 weeks.
* The absence of 2 minor or 1 major markers of aneuploidy.

Exclusion Criteria:

* Other known cause of fetal growth restriction (including congenital anomalies, intrauterine infection, or multiple gestation)
* Reversed end-diastolic flow in the umbilical artery
* Preexisting diagnosis of OSA being treated with aPAP
* Chronic pulmonary disease (cystic fibrosis, moderate persistent asthma)
* Hemoglobinopathies (sickle cell anemia, thalassemia)
* Maternal craniofacial anomalies
* Premature rupture of membranes
Symptom Burden and Health Related Quality of Life of Cancer Patients With Concurrent Heart Failure

To describe and compare the symptom burden in cancer patients with concurrent diagnosis of heart failure (HFrEF compared to HFpEF).

The investigators will conduct a symptom assessment at study enrollment on cancer participants with a concurrent diagnosis of HF (HFrEF and HFpEF) using the MD Anderson Symptom Inventory- Heart Failure (MDASI-HF) and PROMIS Instruments (Fatigue, Dyspnea, and Sleep Disturbance).

The investigators will also describe and compare the health-related quality of life using the European Organization for Research and Training Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and the measure of Quality of Life Short Form-12 (SF-12).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Individuals with a concurrent solid tumor cancer diagnosis
* Not receiving active cancer treatment except for those on maintenance (i.e., Selective ER modulators (SERMs)\[Tamoxifen\], Aromatase inhibitors (Anastrozole, Letrozole, Exemestane), Ovarian suppression therapy (GnRH Agonists \[Leuprolide\], Androgen deprivation therapy for prostate cancer
* Completed cancer treatment at least 3 months and up to 3 years before study enrollment.

Therapy

* Able to read, speak and consent in English
* Ability to understand and the willingness to sign a written informed consent document
* Diagnosis of heart failure, confirmed by echocardiogram, MUGA, or cardiac catheterization
* Internet access via smart phone, tablet, a computer, or another device with the capacity to 1) download the Fitbit App and 2) complete electronic study assessments via REDCap.

Exclusion Criteria:

* Participants undergoing active cancer treatment.
* Inability to provide consent in the medical record, such as cognitively impaired individuals.
Saccharomyces Cerevisiae for Irritable Bowel Syndrome

This study is designed to see the response of saccharomyces cerevisiae for symptomatic improvement of patients with IBS


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients between 18 and 75 years of age,
* Patients having confirmed IBS according to Rome IV criteria (newly and previously non-responder to treatment),
* Pain/ discomfort score strictly above 1 and strictly below 6 as determined on a pain/ discomfort scale using arbitrary grading from 0 to 7 in 7 days preceding the inclusion visit,
* Not hypersensitive to any of the ingredients of the drug.

Exclusion Criteria:

* Patients with an organic intestinal disease (Crohn's disease, ulcerative colitis, etc.),
* Pregnant females
* Treatments likely to influence IBS (anti-depressants, opioids, and narcotic analgesics)
* Patients with chronic alcoholism, vegetarian or vegan regimens
* Eating disorders such as anorexia or bulimia
* Documented food allergies.
Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions

The aim of this study is to develop and validate an adequate protocol of volatolome (volatile metabolites) measurement in breath of human volunteers (18-65 years) to study gut microbiome - nutrition - host interactions in a general healthy population. For this purpose, breath volatile metabolites (BVM) will be analyzed throughout test days in fasting state and after standardized meals using selected ion flow tube mass spectrometry (SIFT-MS). In addition, gut microbial functions linked notably to hydrogen/methane production, carbohydrates utilization (CAZymes), and in the production of other volatile metabolites of interest (i.e. indole, fatty acid derivatives, ...) will be unraveled through microbiome sequencing data analysis (in silico), metabolomic analyses and measurement of enzymatic activities from saliva, urine and/or fecal samples.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man, aged of 18 to 65 years;
* Body mass index (BMI) between 18 and 30 kg/m2;
* Non-smoker;
* Provision of signed and dated informed consent form;
* Stated willingness to comply with all study procedures and availability for the duration of the study;
* Speaking French.

Exclusion Criteria:

* Subject with severe systemic disease (renal or hepatic failure, cancer, pancreatic cancer, chronic pancreatitis, asthma ...)
* Subject with a history or current chronic/severe gastrointestinal disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease of the digestive tract disease (Crohn's disease, ulcerative colitis), celiac disease or irritable bowel syndrome;
* Subjects with a history of digestive tract surgery (except appendectomy);
* Subject who had surgery within the two months prior to the study
* Subjects with psychiatric problems and/or using antipsychotics
* Current or recent (\< 4 weeks) intake of antibiotics, fiber supplement, and/or any products modulating gut transit (laxative, anti-diarrheal, ...) or gut microbiota composition; these products will also be avoided for the duration of the study;
* Chronic intake of drugs, except contraceptive drug;
* Subject following a low-calorie diet and followed by a doctor or dietician in progress or recently (\< 6 weeks);
* Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, intrauterine device (IUD), abstinence, ...);
* Subjects who drink more than 3 glasses of alcohol per day (\> 30 g of alcohol per day);
* Subjects having participated to another clinical trial two weeks before the screening test visit;
* Subjects who practice an intense sport activity (more than 10 hours per week of intense activity);
* Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate to the study.
Evaluation of the Safety of Compressive Socks to Treat Venous Insufficiency in Patients With Peripheral Arterial Disease

Elastic compression stockings are recommended in the treatment venous insufficiency. Degressive compressive stockings have been used for many decades and are characterized by a high pressure applied at the ankle and a decreasing pressure from the ankle to the knee. Progressive compressive stockings were developed to have a maximal pressure at the calf. This concept is based on the calf pump role in the venous return. Patients with PAD (Peripheral Arterial Disease) often suffer from venous insufficiency. But elastic compression stockings are strictly contraindicated for patients with PAD because highest pressures on ankle could slow down the superficial microcirculation.

On patients with PAD and venous insufficiency, the progressive compressive stockings could be well indicated. Strongest pressure at the calf should increase the pump effect and the muscle mechanical efficiency during the walk without deleterious effect.


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from a PAD (systolic pressure index ≥ 0,60 and ≤ 0,75) and having moderate venous insufficiency or classified as C1s to C4 using the CEAP classification
* Age over 18 years
* French health insurance
* Signed informed consent

Exclusion Criteria:

* Hypertension not controlled or hypertensive crisis (risk of non reproducibility of SPI and TBI)
* Diabetes
* Mediacalcosis (SPI not computable)
* Inflammatory arterial diseases of the lower limb
* Permanent edema, lipedema and lymphedema
* Wound and fragile skin
* Phlegmatia coerulea dolens
* Septic thrombophlebitis
* Severe coronary artery disease
* Oozing and infectious skin diseases, skin ulcers
* Known hypersensitivity to components of the study compressive stockings
Mulligan Straight Leg Raising Versus Post Facilitation Stretch on Hamstring Flexibility in Physiotherapy Students

There are several research on Mulligan's techniques that have demonstrated their effectiveness in lowering hamstring tightness, and Mulligan is a pain-free therapy that may be used on any patients complaining of low back pain and hamstring tightness. the purpose of this preliminary study was to determine the effect of Mulligan technique versus post facilitation stretch technique on hamstring flexibility in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* age 18-25 years
* had 20-50 degrees active knee extension loss with hip and knee in 90 degrees (popliteal angle)

Exclusion Criteria:

* lower limb and spinal deformity,
* hamstring injuries and tightness associated with muscle soreness,
* history of fracture or surgery of back pelvis,
An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia

An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia

This is a Phase 3, multi-center, open-label extension study to evaluate the long-term efficacy and safety of odevixibat in patients with Biliary Atresia (BA). Patients who completed treatment in the A4250-011 BOLD study and meet eligibility criteria for Study A4250-016 (BOLD-EXT) can participate. The duration of the treatment period is 104 weeks, followed by a 4-week Safety Follow-up Period. Patients who wish to continue receiving odevixibat after 104 weeks can remain on treatment in the optional extension period (OEP).

Up to 180 patients will be enrolled at approximately 70 sites in the North America, Europe, the Middle East and Asia-Pacific.

Eligibility Criteria:
Inclusion Criteria:

* Completion of the 104-week Treatment Period of Study A4250-011
* Signed informed consent by caregiver

Exclusion Criteria:

* Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator's discretion
* Any conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study
* Known hypersensitivity to any components of odevixibat
* Patients who are scheduled for a liver transplant or are likely to require a liver transplant in the immediate future based on the investigator's judgment
Evaluating the Efficacy and Safety of Dehypotin® in the Patients With Type 2 Diabetes Mellitus or Cardiovascular Disease

The purpose of this study is to evaluate the Efficacy and Safety of Dehypotin® in the Patients with Type 2 Diabetes Mellitus or Cardiovascular Disease. Eligible patients will be randomly assigned to 1 of 2 arms, either Dehypotin® or placebo, and will receive the diet advisement throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Age 20-75 years
* Diagnosis of type II Diabetes Mellitus for at least 3 months and/or clinical evident cardiovascular disease (CVD)
* A hemoglobin A1c concentration has to be \< 8% before screening

Exclusion Criteria:

* Women of child bearing potential who are pregnant, breastfeeding or not using effective contraceptives
* Known hypersensitivity to Pravastatin or any of its components
* Have a history of homozygous familial hypercholesterolemia or known type III hyperlipoproteinemia
* Significant medical illness
* Known serious conditions, e.g. serum creatine kinase(CK)levels 2.5 times upper limit of normal
* Subjects being treated with drugs influence serum lipid concentrations
* Subjects who have cancer or been receiving the cancer chemotherapy
Eltrombopag in Chronic ITP

This study aims to evaluate the efficacy of eltrombopag on the platelet count in pediatric patients with chronic immune thrombocytopenia.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients with chronic ITP aged 1 to 17 years.
2. Platelet count is less than 30×109 per liter.
3. Patients neither have had spontaneous resolution of the thrombocytopenia nor responded to corticosteroids and/or IV immunoglobulin.

Exclusion Criteria:

1. Patients with clinical and/or laboratory evidence of hepatotoxicity/liver decompensation (Hepatotoxicity due to eltrombopag is defined as increased serum alanine aminotransferase ≥3 times the upper limit of normal (ULN), aspartate aminotransferase ≥3 ULN, alkaline phosphatase \>1.5 ULN, total bilirubin \>1.5 ULN)
2. Patients with history of thrombotic/thromboembolic events.
Module-Based Psychological (MBP) for Community Youths

This waitlist, randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based Psychological (MBP) intervention in reducing mental distress for youths aged 12-30 years in Hong Kong. The participants randomised to the MBP group will receive 4-7 sessions of MBP (in 6 to 10 weeks) in an individual format delivered by frontline social or youth workers trained by professional clinicians. The waitlist control group will receive the same intervention after 6 weeks of waiting plus a 1-month follow-up period. The MBP is designed to improve the youths' abilities/skills in handling moods for better emotional management. Written informed consent will be signed by participants or their parents/guardians if they are under the age of 18.

This randomised controlled trial (RCT) aims to examine the effectiveness of the Module-Based Psychological (MBP) intervention in reducing mental distress for youths in Hong Kong. This intervention study will be delivered in an individual format for 4 sessions of core module in 6 weeks plus/minus 2-3 sessions of tailored-made module in 3-4 weeks by frontline social or youth workers trained by professional clinicians. It is designed to improve the youths' abilities and skills in handling moods for better emotional management. The MBP intervention has two modules: core and tailor-made modules. The core module focuses on emotional management, while the five tailor-made modules include anxiety management, mood and depression management, anger management, sleeping well, and managing self-expectation and compassion. The tailor-made modules will be assigned to youths according to their needs. While the clinical outcome of the MBP is evaluated, its cost-effectiveness is also of particular concern. Planned interim analyses are built into the project for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed and which has the potential to modify the conduct of the study. It is hypothesised that the youths who have received MBP intervention will demonstrate a greater reduction in mental distress, depressive symptoms, and anxiety symptoms compared to the youths in the waitlist control group. Besides, the MBP intervention will be more cost-effective than waiting.

Eligibility Criteria:
Inclusion Criteria:

1. LevelMind@JC users aged from 12-30
2. Reported at-least mild mental distress
3. Have sufficient proficiency in Chinese to understand verbal instructions
4. Able to give informed consent

Exclusion Criteria:

1. Known diagnosis of intellectual disability
2. Known diagnosis of organic brain disorder
3. Known psychiatric diagnosis within two years
4. Current substance abuse
5. Receiving any psychiatric treatments or structural psychological therapies such as cognitive behavioural therapy, mentalisation-based therapy and low-intensity online intervention, narrative therapy, mindfulness, and art-informed therapy
6. Current or active suicidal ideation or attempts