cyrilzakka/clinical-trials huggingface dataset:
Audiovisuell Distraction Via 2d Videoglasses During Catheter Ablation Procedures in Cardiac Rhythm Disorders.

In this randomized controlled trial, amount of sedation exposure and patient satisfaction is evaluated in patients undergoing catheter ablation for rhythm disorders via an audiovisual distraction. Patients are randomized into intervention group (adiovisual distraction) or controll (no intervention).

Study conduct:

After the patient has been informed and given written consent to participate in the study, the patients are randomized. They are either assigned to the control group (in which catheter ablation will take place without video glasses as before) or to the intervention group in which they receive the video glasses during ablation. The randomization into the two groups is done by random allocation.

The patients in the intervention group receive instruction on how to use the video glasses and can familiarize themselves with them. Before the patient (as well in the intervention as in the control group) is taken to the EPU laboratory, he receives the first questionnaire in which the personal data and his mood / feeling of fear are collected. In addition, two questions on instrumental-qualification media studies should give an indication of possible relationships between the evaluation of video glasses. The patient is then led into the laboratory and connected to the monitoring by the team. Before it is covered under sterile conditions, the patients in the intervention group receive the glasses and remote control with which they can select the footage from the media library.

The anesthetist will inject a basic dose of sedative and analgesic (determined on the basis of body weight) into each patient and increase it if pain or agitation is noticeable. All patients receive their individual dosage to ensure painless ablation. During the examination, the vital parameters (blood pressure and heart rate) are documented at specified times.

After completing catheter ablation, the video glasses (for patients from the intervention group) are removed. The patients receive a second questionnaire in which they evaluate the use of the video glasses.

Both the subjects in the intervention and control groups are asked to estimate the duration of the examination. The subjective sense of time is intended to provide information as to whether the patients in the intervention group experienced adequate distraction compared to the patients in the control group.

Follow-up:

On the day after catheter ablation all patients receive the CSQ 8 questionnaire, which assesses patient satisfaction using categorical questions. A longer-term follow-up is not necessary.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing catheter ablation for rhythm disorders

Exclusion Criteria:

* epilepsy
* age \<18 years
* visus \<-5 dpt or \>+2 dpt
Evaluation of Nail Technicians With Quick Exposure Check

This cross-sectional study evaluated the ergonomic risks and occupational symptoms among 35 female nail technicians using the Quick Exposure Check (QEC) and the Extended Nordic Musculoskeletal Questionnaire (NMQ-E).

This clinical cross-sectional study assessed 35 female nail technicians from 14 salons in four districts on the European side of Istanbul (Bahçelievler, Küçükçekmece, Beylikdüzü, and Esenyurt). Data collection included interviews, questionnaires, and ergonomic evaluations. The European Community Respiratory Health Survey and the Extended Nordic Musculoskeletal Questionnaire (NMQ-E) were used to assess symptoms, while ergonomic risks were evaluated using the Quick Exposure Check (QEC) by trained physiatrists. Following the assessments, technicians received ergonomic training on posture correction and risk prevention.

Eligibility Criteria:
Inclusion Criteria:

* Female nail technicians aged 18-40 years.
* Actively working as a nail technician for at least six months.
* Willingness to voluntarily participate in the study.

Exclusion Criteria:

* Pre-existing musculoskeletal disease diagnosis.
* Rheumatic or neurological diseases.
* Central sensitization syndromes (e.g., fibromyalgia, chronic fatigue syndrome).
* Psychiatric illnesses or mental disorders impeding communication.
A Study to Evaluate the Drug-Drug Interaction Between Enlicitide Decanoate (MK-0616) and Alendronate in Healthy Adult Participants (MK-0616-027)

The goal of this study is to learn what happens to a single dose of alendronate over time in a healthy participant's body when the participant is given a single dose of enlicitide decanoate. Researchers want to learn how safe and tolerable is the co-administration of enlicitide decanoate and alendronate.


Eligibility Criteria:
Inclusion Criteria:

* Has no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
* Has a body mass index (BMI) ≥18.0 kg/m\^2 and ≤32.0 kg/m\^2 (inclusive)

Exclusion Criteria:

* Has a history or presence of abnormalities of the esophagus which delay emptying such as stricture or achalasia
* Has a history of cancer (malignancy)
* Has a history of gastrointestinal disease which may affect food and drug absorption
Clinical and Biochemical Effects of Multipass Hemodialysis

The purpose of this study is to investigate whether recycled dialysis fluid can supply enough clearance for hemodiaysis patients.

Conventional hemodialysis uses large amounts of water, which hinders travel possibilies for home hemodialysis (HD) patients. We have developed a recycling system using 25-30 l dialysate per dialysis. In vitro investigations show that this results in adequate dialysis.

12 HD patients will be studied during two dialysis sessions. The first HD will be a conventional 4 hour dialysis, using single pass dialysate. The second will be an 8-hour HD using multipass (recycled) dialysate 25-30 l. Clearance of urea, creatinine, phosphate and cobalamin will be measured both in the patient and the dialysate. Patient symptoms will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Stable chronic HD patients
* Informed consent

Exclusion Criteria:

* Age \<18 years
* Psychiatric disease
A Trial to Study Neladenoson Bialanate Over 20 Weeks in Patients With Chronic Heart Failure With Preserved Ejection Fraction

The objective of the study is to find the optimal dose of once daily oral neladenoson bialanate (BAY1067197) when given in addition to appropriate therapy for specific comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Men or women aged 45 years and older
* Diagnosis of chronic heart failure, NYHA (New York Heart Association) class II-IV, LVEF (left ventricular ejection fraction) ≥ 45% and elevated NT-proBNP

Exclusion Criteria:

* Acute decompensated heart failure within the past 4 weeks
* Inability to exercise
* Previous diagnosis of HFrEF (heart failure with reduced ejection fraction) (LVEF \< 40%)
Blended Unified Protocol in Chinese Adolescents with Non-Suicidal Self-Injury

This study utilizes the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) to address non-suicidal self-injury among Chinese adolescents. This program is an annualized cognitive-behavioral therapy designed for adolescents aged 12-17 years who engage in non-suicidal self-injury behavior. Its primary goal is to reduce the intensity and frequency of distressing emotional experiences by teaching adolescents how to confront and respond to these emotions in more adaptive ways. In turn, this helps reduce self-injury impulses and behaviors. The UP-A is adapted to the Chinese cultural context and delivered as a blended treatment, combining face-to-face and online sessions. The study will assess the feasibility, acceptability, and preliminary efficacy of this intervention through a single-arm design, which includes pretest, posttest, and follow-up assessments.

The blended UP-A includes 8 weekly modules, 6 of which (Module 2 - 7)are online self-guided sessions. The online self-guided sessions will last approximately 45 minutes each. Over the course of these 6 weeks, participants will also have 6 therapist-guided online sessions via videoconference, each lasting 30 minutes. Two face-to-face individual sessions are scheduled, one at the beginning of each (Module 1) and one at the end (module 8), each with an expected duration of 90 minutes.

Eligibility Criteria:
Inclusion Criteria:

1. Aged between 12 and 17 years;
2. Engaged in non-suicidal self-injury (NSSI) at least 5 times in the past 12 months, with at least 1 episode in the past month;
3. Minimum education level of primary school or above;
4. Participant and guardian fully understand the research content and agree to participate, with signed informed consent provided.

Exclusion Criteria:

1. Suicide attempts in the past month or a score of ≥17 on the MINI National Neuropsychiatric Interview for Children (MINI KID 5.0), indicating a high risk of suicide;
2. Diagnosis of a psychotic disorder, manic or hypomanic episode, autism spectrum disorder, or other serious neurodevelopmental disorders according to the DSM-5;
3. Presence of severe physical illness or other medical conditions that may affect the completion of treatment and evaluation;
4. Currently receiving other professional psychotherapy or participating in another NSSI intervention study;
5. Received 5 or more sessions of cognitive behavioral therapy (CBT) in the past 5 years;
6. Having received electroconvulsive therapy (ECT) within the past 6 months.
Prevalence of Sensitization to Legumes in a Region From Southern France (Légumineuses)

The Mediterranean diet is a model for health. Indeed, according to some epidemiological studies, it would participate in the prevention of various diseases such as cardiovascular diseases, diabetes type 2, cancer and obesity. Among the foods composing the Mediterranean diet, wheat and legumes are strongly represented. The introduction of legumes into an easily prepared and economical food for a large part of the population will lead to an increase in consumption. The combination of durum wheat semolina and legume flour would benefit from the nutritional qualities of the two raw materials (high protein, slow digestible carbohydrates, fiber, vitamins and minerals), but also of their double wheat-legume allergenicity.


Eligibility Criteria:
Inclusion Criteria:

* Patients seen in allergy consultation
* The patient (or parents for the under 18 years) must have given their free consent and signed the consent chart
* Men and women are included
* The patient is at least 2 years old

Exclusion Criteria:

* The patient is pregnant
* The patient is breast-feeding
* The patient is unable to stop in antihistamine medication for at least 7 days
* The patient refused or is unable to sign the consent chart
* The patient has a dermographism
Primary HPV-based Cervical Cancer Screening Algorithms in Botswana

Primary high-risk human papillomavirus (HPV) testing has become first line screening for cervical cancer in high-income countries. The feasibility of this approach in low- and middle-income countries (LMICs) is less clear, as is the role of HPV testing among women living with human immunodeficiency virus (HIV). The proposed study seeks to evaluate the accuracy of cervical cancer screening algorithms using primary HPV testing followed by various forms of visual evaluation, including visual inspection with acetic acid (VIA), colposcopy and automated visual evaluation (AVE) for the detection of high-grade cervical dysplasia, using histology as the gold standard. We will validate the AmpFire Assay for HPV self-sampling in our setting. We will determine safe screening intervals in women living with HIV (WLHIV) in an HPV-based cervical cancer screening program and compare triage strategies for positive HPV results at WHO recommended screening intervals for WLHIV. We also seek to understand in-depth the attitudes, acceptability and preferences regarding cervical cancer screening, HPV testing, and self-sampling, for women in Botswana through interviews of a sub-set of women recruited for the cervical cancer screening study. Finally, we will analyze the cost of two-stage cervical cancer screening algorithms using high-risk HPV testing in Botswana.


Eligibility Criteria:
Inclusion Criteria:

1. Cis-gender female or transgender male (must have a cervix)
2. ≥25 years of age
3. Competent to understand study procedures and give informed consent.

Exclusion Criteria:

1. Currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy)
2. Previous hysterectomy
3. Previous diagnosis of cervical cancer
Tissue Changes in Lumbar Multifidus After Dry Needling in Subjects With Nonspecific Low Back Pain.

Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.

Lower back pain in regarded as the main cause of disability in the world, which has a significant socio-economic impact. Deep dry needling is effective in handling such pain and is one of the techniques of choice by physiotherapists. In this area, the use of ultrasound provides information of interest such as length, thickness, diameter, cross-sectional area or muscle volume, among others.

Objective: Finding out if tissue changes (thickness, histogram and shrinkage rate) that occur in the lumbar multifidus after deep dry needling are related to changes in patient's pain and disability.

It's a double-blind randomized clinical trial in parallel groups. Patients will be randomly divided into 2 groups. One of them will receive dry needling and the other dry needling placebo. The initial, post-needling and a week after evaluations will be performed by a blinded to the intervention therapist.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years.
* Nonspecific pain in the lumbar region.

Exclusion Criteria:

* Previous surgery in the lumbosacral spine.
* Osteoporosis.
* Needle phobia.
* Neurogenic pain with positive tests or negative symptoms.
* Red flags: cauda equina syndrome, sudden weight loss, fracture, cancer, infection or systemic diseases.
* Pregnancy.
* Physiotherapy intervention in the 4 weeks prior to the intervention.
Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens),
* Prevalent cases of pulmonary artery hypertension (≥ 6 months) confirmed by right heart catheterism,
* Stable for at least 3 months,
* Written consent.

Exclusion Criteria:

* Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc).
* Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.
Safety Study of BMS-770767 in Subjects With Hypercholesterolemia

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)


Eligibility Criteria:
Inclusion Criteria:

* Hypercholesterolemia
* Currently taking a stable daily dose of statin therapy
* Serum triglyceride level \< 500mg/dl

Exclusion Criteria

* History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
* Congestive heart failure
* Diabetes mellitus
* Active liver disease
* Impaired renal function
* Hepatitis C, B and HIV

This list is not inclusive additional information is provided in the protocol
Lesion Load and Location in Relation to Cognition, Fatigue and Physical Disability in RRMS

In relapsing remitting multiple sclerosis (RRMS) the relationship between cognitive impairment (CI), fatigue and physical disability with white matter lesion load (WM-LL), location among other volumetric measures using automated platforms is still unclear.

Cognitive impairment (CI) and fatigue have been recognized as an important feature of MS, affecting up to 70% patients (1), evident since onset and increase in both prevalence and severity as the disease progresses (2). In fact, their effects on patients and even their caregivers are more pronounced than clinical disability, causing unemployment, treatment non-adherence, personality changes as well as several psychosocial dysfunctions (3-5). Therefore, beside evaluating the physical disability, it is essential for health professionals to objectively evaluate either the cognitive function or fatigue at both baseline and during routine follow up visits for early detection and management (6). Through the advances in MRI techniques and availability of a number of automated software, quantitative radiological assessments became more readily available and feasible in daily practice (7) allowing objective longitudinal monitoring of patients (8,9). Although burden and location of lesions in RRMS is thought to be associated with cognitive impairment (CI), fatigue and physical disability, some controversy results were obtained from previous studies. So, by conducting this study, we aimed at exploring the relationship between different parameters of lesion load and location with fatigue, cognitive and physical disability in RRMS patients.

Eligibility Criteria:
Inclusion Criteria:

* : adult patients of both sexes diagnosed with RRMS according to 2017 McDonald diagnostic criteria

Exclusion Criteria:

* Patients with relapse or steroid administration in the past 30 days were excluded. Patients who have any medical conditions that may affect cognition, and those on psychoactive pharmacotherapy were also excluded.
Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as Cystone regarding their ability to dissolve existing kidney stones and prevent formation of new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first phase of the study will be two 6 weeks periods during which each subject will receive Cystone or placebo in random order (with a one-week wash out between 6 week treatment periods). The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by Computerized Tomography (CT) scanning.

Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Subjects must have a measurable stone by CT. The first phase is a double blind, randomized, placebo controlled cross-over of Cystone and placebo for 6 weeks each separated by a 1 week washout. Entry, 6 and 12 week 24 hour urine supersaturations or cystine, pH and sodium determinations will be collected. Then all patients enter an open label phase of 46 weeks, ensuring a 52-week total exposure to Cystone during the 59 week study. Baseline and 1 year stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone burden. Stone burden was measured by CT, quantitatively for stone density and volume. All CT images were also reviewed in a blinded fashion by a radiologist to score each kidney as increased, no change or decreased stone burden.

Statistics and Randomization: Randomization was accomplished using a table provided by the department of statistics to the study coordinator who was blinded as to whether the patients received placebo or Cystone®. Biochemical and supersaturation results were analyzed via a matched pair analysis using the JMP software package (SAS Instituted, Inc.); P values \< 0.05 were deemed significant.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent In the cystine arm, all patients will have the diagnosis of cystinuria, made on the basis of a 24-hour urine cystine containing more than 1500 umol of cystine, or a stone compositional analysis of cystine
* Presence of an existing cystine stone in one or both kidneys In the calcium arm, all patients will have a history of a calcium stone as determined by laboratory analysis.
* Medically effective birth control if fertile female
* Able to comply with protocol

Exclusion Criteria:

* Pregnant
* Subjects under age 18 years
* Obstructing stones
* Urinary Tract Infection that cannot be cleared with single course of antibiotic
* Subjects who decline to provide informed consent
Evaluation of the Transitional and Lifelong Care Program

The population cared for in the Transitional and Lifelong Care (TLC) clinic is youth and adults with childhood-onset disability, of which the large majority are adults with brain-based, neurodevelopmental conditions such as cerebral palsy, spina bifida and developmental disability. The TLC program was created to address the health inequities that have long existed for this population because of the gaps in care they experience once they transition from pediatric healthcare services to the adult healthcare sector. The TLC program offers coordinated and comprehensive management of co-occurring mental, social and physical health conditions for this group of adults with neurodiverse conditions. The proposed study will provide much needed evaluation of the TLC model as an intervention to provide transitional and lifelong care that reduces the barriers experienced because of the undefined clinic path - potentially more appropriately referred to as a "cliff" by a Freeman et al., (2015) - for these individuals. With appropriate evidence of effectiveness, scaling of the TLC program to other Ontario Health regions and more widely across Canada would improve access healthcare providers who are knowledgeable and competent in the management of physical and mental health conditions for adults with neurodiverse conditions as well as service integration and coordination between social and health sectors. The TLC clinic was co-designed with adults with neurodiverse conditions and health care providers in 2014 and represents a significant and sustainable change in the way healthcare has been delivered for this population in the Ontario Health West region over the last 7 years. More than 750 people have accessed coordinated and comprehensive care from Physiatrists, a Nurse Practitioner, Social Worker, Physiotherapist, Occupational Therapist, Speech Language Pathologist, Registered Dietitian and Rehabilitation Therapist in the TLC program since it began, documenting the effectiveness of this care has the power to re-shape care received for adults with neurodiverse conditions that onset in childhood in Canada.


Eligibility Criteria:
Inclusion Criteria:

Each participant dyad will consist of one person, of either sex and gender, who is over the age of 21 years with a childhood-onset disability, and the primary caregiver (based on contact hours) or support person, of either sex and gender, involved in their care. In cases where the patient participant is independent with care, a spouse or family member may still participate in the caregiver portion of the study.

2. Patient participants will have continuously resided in Ontario during the years of 2015 to 2020 to facilitate full data retrieval from the administrative dataset.

3. Healthcare providers, of any discipline, who provide care to adults with childhood-onset conditions in the TLC program.

Exclusion Criteria:

Patient participants will be ineligible if they are in a phase of deterioration associated with a progressive health condition identified either personally or by the caregiver participant.