cyrilzakka/clinical-trials huggingface dataset:
The Effect of Music on Sleep Quality in Behçet's Patients

The aim of this study was to evaluate effect of music on sleep quality in patients with Behçet's disease. The population of the study consists of behçet patients who applied to the Rheumatology outpatient clinic of Medical Faculty Hospital, who met the research criteria and agreed to participate in the study.

The study will conduct in a randomized controlled experimental design with two groups. The sample of the study will be 50 behçet patients the music practice group (25) and the control group (25). The research will be carried out between December 2022 and December 2023. In this study, data will with collect Descriptive Information Form, Behçet's Syndrome Activity Scale (BSAS) and Richard-Campbell Sleep Scale (RCUI).

This study will be conducted as a parallel group randomized controlled experimental study to determine the effect of listening to music in the uşşak makam on sleep quality in Behçet's Diseases.The population of the research will be Behçet's patients receiving outpatient treatment in the Rheumatology outpatient clinic of a university hospital.G.Power program was used to calculate the sample size of the study. In descriptive studies, the t tests - Means: Difference between two independent means (two groups) model was used to determine the sample size when the number of individuals in the universe was not known. While determining the sample volume in the research, the test for the main hypothesis was determined at the first stage and the required averages were obtained from Bakır's research in 2019, which is compatible with our study in the literature (Bakır, 2019). According to the g-power analysis, with 95% confidence level and α=0.05 margin of error, it has an effect size of 0.941 and a tolerance ratio of 5%; In this study, the power of the test was determined as p: 0.05, (1-β): 90%, t = 2.015, and in line with this information, it was concluded that the number of samples required for the study was 46 people in both groups. Considering the possible losses from the experimental study, the number of samples was increased by 10% and it was decided that the total sample size would be 50 people, 25 people in the intervention group and 25 people in the control group.Application In this study, intervention and control groups will be studied in a pre-test and post-test design. No intervention will be applied to the control group. Passive music listening practice for the intervention group.

Eligibility Criteria:
Inclusion Criteria:

18 years or older Having been diagnosed with Behçet's Disease for at least 6 months A score of 0-25 on the Richard-Campbell Sleep Questionnaire No visual or hearing impairment Being literate Ability to understand and speak Turkish Having mental and cognitive competence Not having a psychiatric diagnosis It is voluntary to participate in the study. Not using sleeping pills Become an Android processor phone

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Exclusion Criteria:

Unreachable during phone calls with sleep apnea Chronic diseases that can affect sleep such as COPD, Asthma, Heart failure not continuing research Patients using sleeping pills

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School-based Program for the Prevention of Rheumatic Heart Disease in Endemic Regions

The overall objective of the PREVENT trial is to evaluate the effectiveness of an integrated, school-based program for the prevention of rheumatic heart disease (RHD) in regions with an endemic pattern of RHD.

We conduct a stepped wedge cluster randomized trial in randomly selected schools in Nepal and Zambia.

The intervention will be delivered at the level of the school and consists in the introduction of a dedicated school-nurse program providing health care through education about RHD, assessment, intervention, and follow-up of GABHS pharyngitis, and facilitation of secondary antibiotic prophylaxis for children with RHD.


Eligibility Criteria:
Inclusion Criteria:

- Children aged 5-16 years

Exclusion Criteria:

* Children / primary caregivers not providing informed consent to participate
* Children not attending one of the selected schools
Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age or older with active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Central retinal thickness ≥ 300 µm
* Visual acuity between 20/400 and 20/32
* Eligible for Anti-VEGF therapy

Exclusion Criteria:

* Previous treatment for CNV due to AMD
* High eye pressure
* Glaucoma
* Uncontrolled systemic disease
* Known allergy to the study medications
* Recent eye surgery or injections in the eye
* Female subjects that are of childbearing potential
Performance Assessement for Paralympic Athletes

The primary objective of the study: improvement of sportive performances by quantification and performances monitoring of paralympic athletes.

The secondary objectives of the study:

* quantification and performances monitoring of mechanical performances during the filed tests, the laboratory analysis and the sportive competitions;
* quantification and performances monitoring of physiological performances during the filed tests, the laboratory analysis and the sportive competitions;
* quantification and risk monitoring of discipline-relative musculo-squeletic troubles, caused by training or using of sportive equipment;
* quantification and mechanical monitoring by the made-to-measure or usual sportive material.

The sportive performance results from a range of determinations such as: physiological, biomechanical, morphological, psychological, social and environmental factors. The interactions between athletes, equipment, training and environment influences the development of athletes' performance. In the context of the coming Paris 2024 Paralympic Games, the performance construction for the exploration, the quantification and the management of all factors is an commun objective between sportive team, medical team and researchers.

Eligibility Criteria:
Inclusion Criteria:

* High-lever paralympic athletes registered on the ministerial list or selected by Parasport Federation of France or Shooting Federation of France;
* Aged \>= 14 years;
* Informed consent signed by adult athlete or by holder of parental authority or guardian for minor athlete;
* Covered by social security system.

Exclusion Criteria:

* Temporary or definitive contraindication to the practice of the affected sport activity;
* Undergoing anti-coagulated treatments;
* Cognitive disabilities conducting impossibility to participating to clinical trial, such as serious cognitive troubles, behaviors troubles, psychic troubles or upgraded curatorship needing;
* Under guardianship or judicial decision;
* Ongoing pregnancy.
Superiority of Intelligent Video Surveillance + Telealarm Over Telealarm Alone in Elderly People at Risk of Falling

Maintaining the elderly at home and preventing them from falling are major public health issues. The vast majority of elderly people wish to remain at home. The fear of a fall with prolonged standing is a frequent reason for institutionalization. There are few procedures that have been shown to be effective in preventing falls and their complications. Prolonged standing on the floor is a major complication that can lead to multiple events, including death.

Tele-alarms are widely used in France and in Europe, but their effectiveness in the event of a fall is poor and their use is restrictive (they require physical and mental capacities to activate). However, elderly people at risk of falling are often frail or dependent, suffering from cognitive disorders and sometimes polymorbid, which explains the large number of failures of tele-alarms. There are other alert systems, notably intelligent video surveillance systems such as the VA2CS. This is a video system placed in the home that analyzes the position of subjects in real time using algorithms based on artificial intelligence. The system works continuously without video capture and sends an alert with a photo if a person is lying down after a fall. The alert is confirmed after an operator has checked the photo capture on a dedicated platform. To date, it has a sensitivity and specificity of over 90% (manufacturer's data not published). Its performance is equivalent to other intelligent video surveillance systems published in the literature. This system is autonomous and does not rely on the abilities of the person at risk of falling. Intelligent video surveillance is an innovative technology which has not yet been evaluated in a geriatric care program, nor compared to a reference or analyzed from a quality of life or medico-economic perspective.

The hypothesis of this study is that intelligent video surveillance allows an exhaustive and early detection of the fall with a faster alert enabling to avoid prolonged standing on the ground and its consequences compared to the tele-alarm alone.


Eligibility Criteria:
Inclusion Criteria:

* Person aged 75 years or more
* hospitalized in an acute geriatric service or in a geriatric or multipurpose rehabilitation care service
* If living alone: receiving at least one visit per day from a relative or professional
* Recent history of fall and monopodal support \< 5 seconds
* Able to give informed consent.
* Return home considered complex by the patient or their relatives due to the risk of falling at home.

Exclusion Criteria:

* Under legal protection
* Not affiliated to a social security system
* Confined to bed or chair
The Cholelithiasis in Adults With Short Bowel Syndrome

Short-term studies have shown that patients with short bowel syndrome (SBS) often develop cholestasis or cholelithiasis. In this retrospective cohort study, we aimed to define the incidence, risk factors, and clinical consequences of cholelithiasis in adults with SBS over an extended time period.

However, only limited data are available regarding cholelithiasis in patients with SBS. The prevalence of cholelithiasis in patients with SBS has been reported only in two studies. Furthermore, few studies have focused on identifying the risk factors for cholelithiasis in patients with SBS. Considering the marked improvements in medical care and nutrition support during the last 2 decades, the current incidence and risk factors for cholelithiasis in patients with SBS are unknown.

The aim of the current study was to provide comprehensive, longitudinal, and long-term data on the incidence of symptomatic and asymptomatic cholelithiasis in a cohort of patients with SBS, in order to identify the prevalence, risk factors, and clinical consequences of cholelithiasis in patients with SBS to aid in the development of protective interventions.

Eligibility Criteria:
Inclusion Criteria:

All eligible adults diagnosed with SBS

Exclusion Criteria:

age \<18 years; history of cholelithiasis before SBS diagnosis; cholecystectomy; biliary tract obstruction or no abdominal imaging (CT, MRI, or ultrasound) after SBS diagnosis.
An Observational Study of Tarceva (Erlotinib) in Elderly Patients With Advanced Non-Small Cell Lung Cancer

This prospective observational study will evaluate the efficacy and safety of Tarceva (erlotinib) in elderly patients with advanced non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Data of patients treated with Tarceva in routine clinical practice will be collected for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \> 65 years of age
* Locally advanced or metastatic non-small cell lung cancer (Stage IIIb or IV)
* Failure of at least one prior standard platinum-based chemotherapy

Exclusion Criteria:

* Age \< 65 years
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus

Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Confirmed pregnancy
* Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
* Willing to wear up to the required number of Systems for the total duration of study wear
* Able to follow study procedures;
* Able to speak, read, and write in English or Spanish.

Exclusion Criteria:

* Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites
* Known allergy to medical-grade adhesives
* Hematocrit outside specification
* Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy
* Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period
* Currently using Hydroxyurea for treatment
* Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period
The BRIDGE Project

The BRIDGE project: A feasibility randomised controlled trial of brief, intensive assessment and integrated formulation for young people (age 14-24) early in the course of borderline personality disorder.

This project is the first step in testing a new intervention programme, called BRIDGE (Brief, Intensive Assessment and Integrated Formulation), for young people early in the course of Borderline Personality Disorder (BPD). The BRIDGE Project will help us find out whether we can do a much bigger study in the future that will tell us whether BRIDGE works well. BPD is characterised by long standing difficulty in managing emotional responses, personal relationships, impulse control and self-image. Research shows that individuals with BPD may experience discrimination and resulting stigmatisation by both the public and health care professionals. Many adolescents and young people with complex needs and high suicide risk are left under-diagnosed and untreated. As a result, young people with BPD are frequently not in education or training and experience challenging relationships with friends and families. The overall aim of the study is to assess the possibility of providing a treatment programme for young people with BPD symptoms in the general population, who may or may not be accessing any mental health services. First, we need to see whether young people are comfortable with random allocation to BRIDGE (AND service as usual) or Service-as-usual (ALONE) (a bit like tossing a coin). Second, we need to find out whether enough young people want to be involved. Third, whether we can find out the information we need about them and can follow up enough young people later. The proposed study will try to find these things out, so that we can design a future, bigger, study to find out whether BRIDGE is good value for young people with BPD.

Eligibility Criteria:
Inclusion Criteria:

* Cut off score of 11 out of 15 on the self-reported SCID-II BPD questionnaire AND subthreshold (3 or 4 out of 9 domains) or threshold (5 and above out of 9 domains) criteria on the SCID-II DSM-V (BPD Module)
* Age 14-25

Exclusion Criteria:

* Currently receiving psychological/counselling /psychotherapeutic treatment for BPD
* Has received psychological/counselling/psychotherapeutic intervention for over 8 sessions in the last 3 months
* Severe or profound intellectual disability, that would preclude full engagement in talking therapy
* Receiving Intensive psychiatric treatment at the time of study entry, for conditions such as acute psychosis or severe eating disorder
* Non-English speaking
Pressure Ulcers in Patients Receiving Enteral Nutrition Therapy and Their Relationship With Gut Microbiota

Participants will be randomly assigned to the experimental group where they will be given enteral nutrition formula rich in zinc and arginine plus a symbiotic (Probinul- Ca.Di.GROUP S.r.l.) once a day for 90 days or the control group where they will receive only the enteral nutrition formula rich in zinc and arginine.

Participants belonging to both experimental and control group will be evaluated at admission (T0), 45 days after admission (T45) and at the end of the study (T90, 90 days after admission). At each time point patients' nutritional status will be determined and the following biochemical parameters will be investigated: lymphocyte count, total proteins, protidogram, prealbumin, transferrin, vascular endothelial growth factor (VEGF), Platelet-derived growth factor (PDGF), beta transforming growth factor (TGF-beta). Analysis of fecal DNA will be also performed to characterize the gut microbiota. In addition, at the baseline and at T45 participants will be administered the Braden scale for predicting pressure sore risk.

Eligibility Criteria:
Inclusion Criteria:

* Patients with enteral nutrition therapy
* Presence of pressure ulcers
* Previous antibiotic therapy

Exclusion Criteria:

* nutrition per os
* absence of pressure ulcers
* absence of previous antibiotic therapy
Digital 3D Reconstruction Predicts Small Bowel Length

The prevalence of type 2 diabetes mellitus (T2DM) has been increasing annually worldwide, and the prevalence of diabetes has reached 11.6% in China. Laparoscopic Roux-en-Y gastric bypass (RYGB) is still widely accepted as a valid surgery in the treatment of obesity and T2DM. But still, there is no consensus on the ideal of the gastric bypass limb lengths. Reported lengths of biliopancreatic limb (BPL) and alimentary limb (AL) varied widely from 10-250 to 35-250 cm, and anatomical data show that the length of small intestine varies greatly among adults. Choosing the same small bowel bypass length for different individuals obviously cannot achieve the expected weight loss effect, and individuals with too short small intestine can cause severe malnutrition complications and even life-threatening conditions. Therefore, measurement of small bowel length is one of the prerequisites for performing precise RYGB. Intraoperative measurement of small bowel length can increase the operative time and the risk of surgical complications such as intestinal perforation. So, predicting the total length of the small intestine is very important for accurately performing bariatric surgery and avoiding the risk of surgical complications. In this study, we propose to perform 3D segmentation and reconstruction of the small intestine by acquiring abdominal CT data through digital technology, and predict the small intestine length by 3D digital measurement of the small intestine, and verify the digital measurement data by performing digital measurement data. Establish a small bowel length prediction model for bariatric surgery to develop a more accurate and personalized gastric bypass surgery plan for patients to obtain weight loss and glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for surgical treatment of T2DM were selected based on the Chinese Guidelines for the Surgical Treatment of Obesity and Type 2 Diabetes (2019 )

Exclusion Criteria:

* Adhesions, peritonitis, and patients who have had bowel resection (small intestine, colon or rectum) that hinder the measurement of the entire intestinal length
* Non-weight loss surgery patients whose incision is less than 6 cm are not suitable for measuring the length of the small intestine.
Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer

The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-center phase II-trial was conducted.


Eligibility Criteria:
Inclusion Criteria:

* histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV
* life expectancy of more than three months
* ECOG performance status less than 3
* laboratory parameters within the normal range, including a glomerular filtration rate (GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver transaminases less than two times the normal levels, bilirubin concentrations below 1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater than 1,500/µl, and a platelet count greater than 100,000/µl.
* written informed consent

Exclusion Criteria:

* suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease
* radiotherapy within 4 weeks for study entry
Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil

As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.


Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as planned.

Exclusion Criteria:

* Treated with an investigational drug, other than sitaxsentan sodium in B1321001 (NCT00795639), or device that has not received regulatory approval within the 30 days prior to Baseline/Day 1 or during the study.
Effects of Prophylactic Massage Therapy on Pain Tolerance and Threshold

Therapeutic massage has been thought to reduce anxiety and increase relaxation in human patients.This study is meant to determine the immediate effects of therapeutic massage on pain tolerance and threshold.

Patients participated in two trials of a pain stimulus test that measured pain threshold and pain tolerance. One trial was titled "Massage Protocol" and the other, "No-Massage Protocol." During the "Massage Protocol," they received a therapeutic massage to the forearm before participating in the pain stimulus test. During the "No-Massage Protocol" they did not receive a massage before participating in the pain stimulus test. Their pain threshold and tolerance for both trials were compared against each other. Each patient was randomized as to which protocol they participated in first.

Eligibility Criteria:
Inclusion Criteria:

-generally healthy

Exclusion Criteria:

* pregnant
* smoker
* cold allergy
* Raynaud's disease
* cryophobia