cyrilzakka/clinical-trials huggingface dataset:
Multi-disciplinary Rehabilitation Program for Advanced Parkinson's Patients in the Community

The present study examines the effectiveness of the rehabilitation program in the framework of the "Ezra LeMarpeh" project for Parkinson's patients. The Ezra LeMarpeh Association, founded by Rabbi A. E. Firer, provides assistance to the sick and needy. The site features a wide range of advanced, high quality rehabilitation devices, a unique hydrotherapy pool and associated accessories that enable the staff to provide the finest quality and most professional treatment. Before entering a rehabilitative program, each participant will arrive independently at the Ezra LeMarpeh Center for evaluation tests and will undergo comprehensive evaluation tests by the center's physiotherapist, including walking tests, balance tests, filling out questionnaires to assess Quality of life and disease severity. At the end of the program, the participants will be asked to repeat evaluation tests.

Before entering a rehabilitation program, each participant will arrive independently at the "Ezra LeMarpeh" Center, at 24 Chida St., Bnei Brak. After a detailed explanation of the nature of the study, the participants will sign an informed consent form. The center's physiotherapists will test walking abilities, motor functioning and abilities in activities of daily living (ADL).

Walking tests can include walking at a comfortable pace, walking while counting (dual tasking), walking at different speeds and more. The balance tests include standing on a small base, standing on one leg, standing with eyes closed, and more. During the tests participants will wear small, non-invasive sensors at the wrists, ankles, and lower back. These sensors include an accelerometers and a gyroscopes that can be used to quantify gait measures, such as gait velocity, step length and variability. Lower back sensors will be worn continuously for up to a week for everyday activity.

At the end of the program, the participants will be asked to repeat evaluation tests.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease, as defined in the UK Brain Bank criteria
2. Hoehn and Yahr stage I-III
3. Patients who are taking anti-Parkinson's drugs.
4. Participants who are in a stable medication regimen during the month preceding the study and are expected to remain in a permanent regime for the next 3 months.
5. Mini Mental State Exam (MMSE) score\> 24
6. Able to walk independently for at least 5 minutes with or without support.

Exclusion Criteria:

1. Any neurological condition other than PD or orthopedic disease (eg after a stroke with neurological signs, MSA, Parkinsonism, PSP, etc.) that may impair normal walking and balance.
2. Significant cognitive impairment MMSE score\<24
3. Any medical, surgical, and / or psychiatric condition which, in the opinion of the investigator, prevents the patient from completing all aspects of the research.
Investigating the Clinical and Cost Effectiveness of Lycra Splinting

People with learning disabilities (LDs) experience high levels of health problems, including cerebral palsy, other problems associated with posture, movement and function, and injury (falls are the commonest cause of injury in this population, and poor balance/coordination are a contributory factor). The aim of this project is to investigate the clinical and cost effectiveness of lycra splinting garments (LSGs), worn to improve posture, movement and function, for adults (16 years and over) with LDs who fall. This project aims to investigate the clinical and cost effectiveness of LSGs to prevent future falls of adults with LDs, to inform practice and guidelines within local and national (National Health Service - NHS) adult services.

Falls and fall injury are a serious problem for people with LDs (people with LDs experience similar rates of falls as the elderly in the general population but at a younger age), whereby interventions are warranted. Lab based 3D movement analysis will be conducted with adults with LDs who fall during two visits to perform simple tasks (e.g. walking) (once prior to being provided with LSG, and once 6 weeks after wearing the LSGs at home).

Adults with Learning Disability who have capacity will be recruited to participate in the Lycra splinting trial via their local physiotherapist. The eligibility criteria is an adult with Learning Disability who has had a fall and who has problems with their balance and/or gait as identified by their local physiotherapist.

The participants will be recruited via participant information sheets. The participants will attend the Glasgow Caledonian University (GCU) gait laboratory to undertake three-dimensional movement analysis; Gaitrite test (the Gaitrite is a commercially available instrumented walkway); and Centre of Pressure testing.

This will take place before prescription of a Lycra splinting garment and a minimum of 6 weeks wear after receiving a Lycra splinting garment.

Analysis of data captured before and after wearing the Lycra splinting garment will take place.

The use-ability of the Lycra splinting garment will also be determined by completion of a user and carer questionnaire and by completion of a questionnaire by their local physiotherapist.

The cost effectiveness of Lycra splinting garments will be analysed by a health statistician within GCU.

Eligibility Criteria:
Inclusion Criteria:

* Participant has a learning disability, and has had a fall within the last 12 months due to a balance or gait issue.

Exclusion Criteria:

* Any participant who does not have capacity to consent.
Real Word Evidence With 1L Polyethylene Glycol (PEG)+ Ascorbic Acid in Iberia

A retrospective study to evaluate the effectiveness and safety of 1L polyethylene glycol (PEG)+ Ascorbic acid given for bowel preparation before colonoscopy.

Observational, retrospective, and multicenter study based on the review of the existing medical records of patients followed on an outpatient basis (computerized databases and dissociated data).

The design implies the incorporation of existing anonymized data by the hospital centers without leaving any record of the code assigned to each patient. The design, therefore, avoids the possible risk of the dissemination of the personal data of patients.

Eligibility Criteria:
Inclusion Criteria:

* Male and female outpatients aged: ≥18 years undergoing a screening, surveillance, or diagnostic colonoscopy between June 1, 2019, to September 1, 2021
* Who have used NER1006 in the preparation of the colonoscopy either in split doses or same day.

Exclusion Criteria:

* History of colorectal cancer o colectomy before the first colonoscopy
* Impossibility to obtain the required mandatory data
Effectiveness Web-based Training on Perinatal Loss

The study was conducted in a randomized controlled parallel group experimental design to determine the effect of web-based supportive care provided to women who experienced perinatal loss on perinatal grief, depression, hopelessness and coping with stress.

Loss, which includes many complex emotions, is the loss of a person or object that is valuable to the individual after having it. Perinatal loss is the most painful situation that pregnancy can potentially result in. With perinatal loss, parents may show behavioral (shock, anger and loneliness) and physical (crying, loss of appetite or overeating, insomnia, irritability, inability to concentrate, forgetfulness, pain, etc.) reactions. However, emotional problems such as grief and depression after loss are more common than physical and behavioral problems. While the prevalence of major depression in society is 3-10%, this rate varies between 10-51% in those who experience perinatal loss. Loss can become a life crisis with biopsychosocial and spiritual dimensions for parents and especially for women.

Eligibility Criteria:
Inclusion Criteria:

* spoke Turkish, had at least primary school level education
* did not have a psychiatric disease diagnosis
* could use and access the internet and information technologies
* did not have vision and hearing problems
* experienced pregnancy loss of 12 weeks or more
* were hospitalized in the perinatology clinic

Exclusion Criteria:

* Women who did not accept to participate in the study
* did not use the internet and information technologies and could not access them
* applied to psychological support units during the training process
* started using psychiatric medication during the training process were not included in the study
Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched with Essential Oils from Laboratoires Gilbert in Patient with Acute Rhinitis Associated with Nasal Obstruction

The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patient ≥ 12 years,
* 2. Patient with acute rhinitis associated with nasal obstruction during infectious episodes such as rhynopharyngitis (cold), rhinosinusitis, or during non-infectious episodes as allergic rhinitis,
* 3. a. Informed adult patient who has given written consent prior to any study specific procedure,
* b. Informed minor patients who has given assent and whose legal guardians have given written consent prior to any study specific procedure,
* 4. Patient able to meet the study requirements (questionnaire completion),
* 5. Patient affiliated to a social security scheme.

Exclusion Criteria:

* 1. Patient who does not want to participate to the clinical investigation,
* 2. Hypersensitivity to seawater and/or known allergies to any of the ingredients of the spray,
* 3. A child with a history of febrile convulsions,
* 4. Diseases leading to respiratory insufficiency,
* 5. Patient suffering from nasal deformity or nasal polyps leading to chronic nasal obstruction,
* 6. Patient on local ans systemic vasoconstrictors, local and systemic corticosteroids and antihistamines, non-steroidal anti-inflammatory (NSAIDs), antibiotics and local antiseptics,
* 7. Concomitant use of other nasal sprays, essential oils for local nasal use and nsal cream or gel,
* 8. Patient under guardianship, curatorship of safeguard of justice.
A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray

The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose


Eligibility Criteria:
Inclusion Criteria:

1. Males and females 18 years of age or older.
2. History of perennial allergic rhinitis for at least 1 year prior to screening.
3. Positive skin test to perennial allergen.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Upper respiratory infection within 14 days of study start.
4. Active asthma requiring treatment with inhaled or systemic steroids.
5. Use of any form of nasal spray during the previous month.
Studying the Effect of Capsinoids on Brown Fat Using Infrared Thermal Imaging.

The primary hypothesis of this study is that consumption of capsinoids increases brown adipose tissue activity, detectable by infrared thermal imaging.

The secondary hypothesis is that consumption of capsinoids can affect an individual's glycaemic response.

It has been recently established that brown adipose tissue (BAT) exists in adult humans. BAT is a thermogenic tissue which dissipates energy as heat. The primary objective of this study is to use thermal imaging to assess the effect of capsinoids on BAT activity in adult humans, and whether there is a relationship between the increase in energy expenditure and BAT activity after capsinoids intake. The secondary objective is to investigate whether capsinoids will have an effect on an individual's glycaemic response. Lean, healthy male volunteers will be recruited. There will be two test sessions which are randomized, where subjects will consume either capsinoids or placebo capsules, and a standardized amount of white rice (equivalent to 50g carbohydrates). Indirect calorimetry will be used to assess energy expenditure before and after consumption of the test meal. Thermal imaging of supraclavicular BAT, the primary BAT depot in humans, will be undertaken using an infrared thermal camera to assess changes in BAT temperature. Blood glucose levels will be monitored by finger prick blood sampling method. This study aims to investigate whether capsinoids consumption leads to changes in BAT temperatures detectable by the infrared thermal camera, to confirm the feasibility of using thermal imaging as a rapid, noninvasive, and reproducible way of studying BAT activity thus providing a platform to advance research in this emerging field of human BAT.

Eligibility Criteria:
Inclusion Criteria:

* Chinese ethnicity
* Male
* Healthy
* Age 21 - 30 years
* BMI 18.0 - 22.9 kg/m2
* Not on any prescribed medication
* Infrequent spicy food or chilli user (less than 3 times per week)

Exclusion Criteria:

* Smoker
* Fasting blood glucose \> 5.5 mmol/L
* Resting blood pressure \> 140/90 mmHg
* Any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders
* Allergic or intolerant to foods presented in the study
The Effects Diflunisal on the Levels of BMS-986165 in Healthy Participants

BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Women and men must agree to follow instructions for methods of contraception.
* Participants must be willing and able to complete all study-specific procedures and visits.
* A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
* WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of active liver disease
* History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug.
* Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day 1.
* Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment.
* History of any significant drug allergy

Other inclusion/exclusion criteria apply
Screening for Glucose Metabolism Disorders in Cardiac Rehabilitation

Because prevalence of glucose metabolism disorders is high in patients with coronary disease, the Oral Glucose Tolerance Test (OGTT) is recommended in all patients without diabetes after an acute coronary syndrome (ACS). However, there are some concerns about its performance in clinical practice. The aim of our study was to evaluate, after an acute coronary syndrome (ACS), the feasibility and efficacy of the OGTT in a cardiac rehabilitation (CR) center in comparison with its real application in the whole French population.

We will select all the patients referred to our Cardiac Rehabilitation center after an ACS. HbA1c will be measured in each patient included in the study. the OGTT will be prescribed in all the patients without known diabetes and with HbA1c \< 6.5%. In order to perform a "real life" study, the OGTT will not performed in the CR center but will prescribed in each patient who will be asked to perform it in an external biological laboratory.

The OGTT will be performed in the morning after a 12 hour fast, with 75g oral glucose load. Plasma glucose will be measured at baseline and 120 min after the oral glucose load. The results will be classified according to the WHO criteria: diabetes is defined as fasting plasma glucose (FPG) greater or equal to 7.0 mmol/L (126 mg/dL) or glucose level 2h (2hPG) after the OGTT greater or equal to 11.1mmol/L (200mg/dL); impaired fasting glucose (IFG) is defined as FPG greater or equal to 6.1 mmol/L (110mg/dL) and less than 7.0 mmol/L and impaired glucose tolerance (IGT) is defined as a 2hPG greater or equal to 7.8 mmol/L (140 mg/dL) and less than 11.1mmol/L.

In parallel, screening for glucose metabolism disorders with the OGTT after an ACS will be evaluated in the whole French population from a representative sample of 1/97ème French population of the "National Health Insurance Inter-Regime Information System" (SNIIRAM) which collects individual hospital and non-hospital data for health care consumption.

Eligibility Criteria:
Inclusion Criteria:

* patients referred to cardiac rehabilitation after an acute coronary syndrome during the 6 precious weeks

Exclusion Criteria:

* none
Risk of Life-threatening Heart Rhythm Disturbances in Siblings

The purpose of this study is to determine if heredity influences the risk of life-threatening heart rhythms (ventricular tachycardia and ventricular fibrillation) after heart attack (myocardial infarction).

Greater than 400,000 persons die suddenly each year in the US. The implantable cardioverter-defibrillator (ICD) has revolutionized the primary prevention of sudden cardiac death (SCD) following myocardial infarction (MI), however, risk stratification remains limited and rests solely on the identification of left ventricular dysfunction. The goal of this study is to determine if genetic factors influence the risk of ventricular arrhythmia remotely after myocardial infarction.

In order to determine if ventricular tachycardia or ventricular fibrillation remotely after MI is a heritable trait, we will conduct a family based case-control sibling study of patients who have received an ICD for ischemic cardiomyopathy. As a first step, we will utilize the GENECARD registry, an existing family linkage study of premature cardiovascular disease, to determine the prevalence of sibling concordance for ICD implantation following MI. Probands and siblings in the GENECARD study will be surveyed regarding their ICD history. The sibling recurrence risk ratio for ICD implantation following MI and subsequent ICD therapies will be used to estimate the sample size required to validate heritability, in a larger patient population. In the validation phase of this protocol, we will use a (1) single healthcare system database (Duke Cardiovascular Databank) and a (2) regional population-based registry, in order to determine concordance for ICD therapies. Patients who agree to participate and provide informed consent will be surveyed regarding their personal ICD history and that of their siblings. The prevalence of ICD therapies will be ascertained in the probands, siblings, and the overall cohort. Sibling concordance for ICD implantation and sibling concordance for subsequent appropriate ICD therapies will be used to determine the sibling recurrence risk ratio for appropriate ICD therapies remotely after MI.

Eligibility Criteria:
Inclusion Criteria:

* patients must be alive
* have a history of coronary artery disease / myocardial infarction
* left ventricular ejection fraction ≤ 35%
* received an implantable cardioverter- defibrillator

Exclusion Criteria:

* nonischemic cardiomyopathy
* Pre-identified hereditary arrhythmia syndrome (e.g. long QT syndrome, Brugada syndrome, etc)
* left ventricular ejection fraction \>35%
* no implantable cardioverter-defibrillator
Cardiac Pathologies in Standard Thoracic CT Imaging

Modern high-end CT scanners with faster scan acquisition times now allow for routine assessment of cardiac pathologies, which could result in numerous incidental cardiac findings on standard thoracic CT angiography (CTA) scans. The CaPaCT-study aims to assesses the presence, management and possible clinical impact of incidental cardiac pathologies which are becoming visible on standard thoracic CT scans performed on new high-end scanners.

A known disadvantage of constantly improving diagnostic imaging is the detection of incidental findings. Computed Tomography (CT) scanner technology is ever improving in both temporal and spatial resolution. Recently developed advanced reconstruction algorithms and dedicated post-processing software reduce image noise thereby improving image quality. Equipped with these advancements, modern CT scanners accomplish well defined imaging of cardiovascular structures. These technical improvements have enabled cardiac assessment on routine standard (non-ECG triggered) thoracic CT scans.

If thoracic radiologists are able to assess the heart and coronary arteries on a standard thoracic CT, this could result in an extensive amount of incidental cardiac findings. Herein lies the potential for large scale reporting of incidental cardiac findings and, consequently, a huge influx of new 'patients' for downstream testing and potential (over-)treatment.

Coronary Artery Disease (CAD) is a known comorbidity for multiple diseases, for example presence of CAD could require a different treatment strategy in lung cancer and worsen prognosis \[Khakoo et al\]. In patients with diabetes mellitus (DM), the incidence of CAD is four times higher compared with the general population, and the risk of a cardiovascular event is two- to four-fold higher \[Kannel et al. + Aktas et al.\]. Therefore, the discussion on management and treatment of these patients with incidental cardiac findings on chest CT evidently is important. Unfortunately, to date no consensus has been reached on the management and reporting of these findings. The CaPaCT study (cardiac pathologies on standard thoracic CT) has been developed to evaluate the visibility and management of incidental cardiac pathologies on a ultra-high pitch thoracic CT-scan with help of the CAD-RADS classification.

Eligibility Criteria:
Inclusion Criteria:

- Standard non-ECG triggered thoracic CT scanning.

Exclusion Criteria:

* Iodine allergy
* Renal insufficiency (GFR \< 30mL/min)
* Pregnancy
* Age \< 18 years
Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the single dose pharmacokinetics of crizotinib in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female of non-child bearing potential subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Subjects with evidence of disease, conditions affecting drug absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, and use of prescription , nonprescription drugs and dietary supplement within 7 days, and blood donation of 500 mL within 56 days.