cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Frailty and Functional Capacity in End-Stage Liver Disease

Development of fibrosis plays a main role in the pathophysiology of liver diseases. The rate of progression in fibrogenesis varies according to the type of underlying liver disease and varies with the environment and host-related factors. End-stage liver diseases are characterized by systemic vascular resistance and decreased arterial blood pressure, increased heart rate and cardiac output . Disruption of regulation of neurogenic, humoral and vascular functions is effective in these cardiovascular changes. In end-stage liver diseases, glycogen storage and corruption of glyconeogenesis cause muscle protein and fat to be used for energy, resulting in weight loss and muscle weakness. According to the latest data of the Republic of Turkey Ministry of Health in Turkey in 2223 patients are waiting for liver transplantation. Acute and chronic liver disease and infectious complications lead to an increase in the number of hospitalizations and prolonged hospital stay and severely affect the functional status and mortality. In recent years, more attention has been paid to complications from chronic diseases, including malnutrition, sarcopenia, poor functional capacity, and frailty. There are few studies in the literature examining functional capacity and physical frailty in end-stage liver disease. The aim of this study was to investigate the relationship between functional capacity and frailty in end-stage liver disease.

The decrease in functional capacity is a finding that affects quality of life in chronic liver diseases. In a study, 6 Minute Walk Test was associated with mortality in patients with cirrhosis and survival was lower in patients walking less than 250 meters. Malnutrition is a common complication of end-stage liver disease. It is a complex condition that causes loss of muscle and fat mass, loss of body weight, increased pro-inflammatory cytokines, anorexia and fatigue, resulting in sarcopenia. Sarcopenia is generally defined as a loss of muscle mass and muscle strength and is directly related to adverse outcomes in these patients. In the evaluation of malnutrition in end-stage liver disease, evaluation of skeletal muscle (mass, strength, functionality) provides an objective way to determine malnutrition, since most intrinsic markers originate from existing liver disease (eg albumin, prealbumin, lymphopenia levels).

Eligibility Criteria:
Inclusion Criteria:

* Follow-up with end-stage liver disease in Hacettepe University Faculty of Medicine, Department of Gastroenterology
* Volunteering for research

Exclusion Criteria:

* Presence of hepatopulmonary syndrome
* Presence of portopulmonary hypertension
* Uncontrolled severe hepatic encephalopathy
* Previous history of liver transplantation
* Presence of orthopedic problems that will affect the research
* Presence of neurological deficits
* Severe chronic obstructive pulmonary disease or heart failure
Psychometric Properties Upper Limb Function Measures Multiple Sclerosis

Current study will investigate de quality (psychometric properties) and clinical utility of several measures of upper limb function, according to disability level. Therefore, several aspects will be inquired:

* Was there an effect of rehabilitation
* Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness)
* Does the measure assess what it claims to measure (validity)
* Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects)
* Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels.

Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of MS according to McDonald criteria
* a treatment goal to maintain or improve upper limb function
* no relapse within the last month
* no changes in disease modifying medication and no corticoid-therapy within the last month
* receive at least 10 sessions of physical or occupational therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months

Exclusion Criteria:

* other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, ...)
* other neurological impairments with permanent damage (stroke, Parkinson, ...)
* MS-like syndromes such as neuromyelitis optica
* not able to understand and execute simple instructions
A Study of Capecitabine (Xeloda) and Peginterferon Alfa-2a (Pegasys) in Treatment-Naive Participants With Advanced Liver Cancer

This study will evaluate the efficacy and safety of capecitabine (Xeloda) in combination with peginterferon alfa-2a (Pegasys) in participants with advanced liver cancer who have had no prior treatment. The anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 75 years of age
* Locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy

Exclusion Criteria:

* Previous treatment for liver cancer
* Main portal vein involvement
* Bone, brain, or leptomeningeal metastasis
* Clinically significant cardiac disease
* Malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract
* History of other cancer, except basal cell skin cancer or in situ cancer of the cervix
Pilot Study of ELK-003 Eye Drops for Treating Ocular Manifestations of Epidermolysis Bullosa

This study consists of two phases: an Observational Phase to evaluate the natural history of ocular manifestations in subjects with Dystrophic and Junctional Epidermolysis Bullosa, followed by a Treatment Phase to assess the effects of ELK-003 eye drops. Each subject will serve as their own control by comparing ocular manifestations documented during the Observational Phase to those recorded during the Treatment Phase.

During this study, subjects will undergo evaluations at three scheduled clinic visits: at enrollment (baseline, time 0), at 4 months, and at the conclusion of the Treatment Phase (6 months post-treatment initiation). Assessments will include OCT imaging, slit lamp examination with photographs, keratograph analysis, visual acuity testing, osmolarity testing, InflammaDry, SPK scoring, Schirmer Test, and opacity scoring. Weekly questionnaires will be completed by subjects to assess symptoms, track corneal abrasions, and evaluate quality of life throughout the study.

If subjects experience symptoms indicative of corneal abrasions, a healthcare provider will conduct a home visit to document the event, using fluorescein staining to confirm and record the corneal abrasion. Corneal abrasion symptoms, frequency, duration, and healing outcomes will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Recessive Dystrophic and Junctional Epidermolysis bullosa
* Frequent history of corneal abrasions (one or more abrasions every 3 months)
* Age: older than 2 years at the time of joining the clinical trial
* Patients and/or parent/legal guardian has given written informed consent in writing

Exclusion Criteria:

* Acute eye infection at time of enrollment
* Patients with severe vision loss (\<20/200) or severe corneal opacification.
* Contact lens wear or nocturnal eye ointment
* Hypersensitivity to fluorescein (ocular stain used in slit lamp study)
* History of alcohol abuse or drug addiction
* Patient who reports difficulty to attend the 4 in-person controls
* Patients who are suffering from cancer
* Patients with any medical condition or situation which in the opinion of the investigators could put the patient at risk, or could interfere with the patient's participation in the study
* Pregnant or breastfeeding women (a pregnancy test will be performed using a urine sample for female patients who have had menarche).
rTMS Brain Stimulation and Cognition

This study will use repetitive transcranial magnetic stimulation (rTMS) (a way to use a powerful magnet to cause temporary impairment to the function of a brain region) to test whether certain parts of the brain are necessary to various aspects of memory and emotion. Participation will require up to three visits. One visit will take up to an hour, and the other visits will each take up to three hours each. During the first visit, participants will be consented, and their brains will be scanned using magnetic resonance imaging.

Memory and emotion are complex cognitive processes. To understand memory and emotion better, it is helpful to break them down into component processes and examine how each of these component processes is supported by brain. One way to do this is to safely and reversibly impair the function of a brain region that are believed to support some of these component processes and observe changes in behavior.

A high-resolution three-dimensional image of a participant's brain will be created using magnetic resonance imaging (MRI) scanning (about 10 minutes in the scanner). Either the same day or on a following day, participants will return and will be exposed to emotional and/or neutral stimuli. Either before or after being exposed to the stimuli, the participants will have their brain mildly stimulated using rTMS. This stimulation will be at or below the levels which the FDA has deemed safe for treatment of depression, and will temporarily reduce brain activity in the targeted area. The behavior of the participant's memory, emotional processing, or related cognitive functions will be tested by asking them questions about emotional and/or neutral stimuli. Depending on which condition the participant is part of, the researchers may then bring the participant back, and repeat this procedure on a different day stimulating another brain region.

Up to 80 participants will be identified via word of mouth, the psychology department research pool, and via flyers posted on Emory campus. Participants will give informed consent to participate and will be compensated for their time.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* healthy

Exclusion Criteria:

* personal or first-degree family history of epileptic seizure
* a known brain injury
* claustrophobia
* taking certain medications that may increase the risk of seizures (e.g., bupropion, varenicline, chlorpromazine, theophylline) or reduce the effects of rTMS, such as benzodiazepines
* current use of medication for neurological or psychiatric conditions
* internal metallic implant, device, or foreign body
* left handedness
Multilevel Intervention Based on Colorectal Cancer (CRC) and Cervical Cancer Self-screening in Rural, Segregated Areas

In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania.

The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted educational materials, to women in rural, segregated areas could help increase cancer screening, reduce geographic cancer disparities, and improve public health.

In this study, the investigators will deliver self-sampling human papillomavirus (HPV) tests and fecal immunochemical test (FIT) kits, as well as adapted cancer screening educational materials, by mail to 110 women who are out-of-date for both cervical and colorectal cancer screenings, recruited through federally qualified health centers (FQHCs) in rural, segregated counties of Pennsylvania. A control group of 110 women, also recruited through FQHCs in rural, segregated counties of Pennsylvania, will be used for comparison; these women will receive standard-of-care reminders for cancer screening and complete the baseline and follow-up surveys.

The hypothesis is that delivering self-sampling HPV tests and FIT, as well as adapted educational materials, to women in rural, segregated areas could help increase cancer screening, reduce geographic cancer disparities, and improve public health.

Eligibility Criteria:
Inclusion Criteria:

* lives in rural, segregated county of Pennsylvania
* able to speak, read, and communicate well in English
* out of date for both cervical and colorectal cancer screening

Exclusion Criteria:

* has had a partial or complete hysterectomy
* has a family history of colorectal cancer
* has a personal history of cervical or colorectal cancer
* persons who are cognitively impaired
* persons who are incarcerated
Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy Participants

The purpose of this study is to evaluate the pharmacokinetic (PK), pharmacodynamic (PD), and safety and tolerability of evobrutinib after oral administration of immediate release (IR) and modified release (MR) formulations in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants are overtly healthy as determined by medical evaluation, including comprehensive clinical assessment (detailed medical history and a complete physical examination), ECG, and laboratory investigations (hematology and biochemistry)
* Participants have a body weight within 50.0 to 100.0 kilogram (kg) and body mass index (BMI) within the range 19 to 32 kilogram per meter square (kg/m\^2) (inclusive)
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* Participants with history or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, metabolic, hematological, lymphatic, neurological (including epilepsy), cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, connective tissue diseases or disorders, as determined by medical evaluation
* Participants with history of any malignancy
* Administration of live vaccines or live-attenuated virus vaccines within 3 months prior to Screening. Administration of other types of vaccines (e.g. SARS-CoV-2 vaccines) is allowed until 2 weeks before the admission to the CRU
* Medical history and physical examination results that include any ongoing clinically relevant findings as judged by the Investigator
* Moderate or strong inhibitors or inducers of CYP3A4/5 or Pgp within 4 weeks prior to the first administration of study intervention
* Other protocol-defined exclusion criteria could apply
Project Prepared: Risks, Roles and Relationships

Project Prepared is a theoretically based, comprehensive, intensive group intervention that is designed to prepare early adolescents for middle adolescence and its challenges. It emphasizes skills in avoiding risky sexual situations, and provides medically accurate information about sexual development, sexually transmitted infections and pregnancy. Effectiveness is measured by using a randomized control trial design and tracking differences in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs, relationship self-efficacy), gender norms (macho man, powerless female), and resilience.


Eligibility Criteria:
Inclusion Criteria:

* 12-14 yrs old
* lives in the Bronx, NY at Baseline
* Has been seen at some point in one of the Montefiore Medical Center community health clinics.

Exclusion Criteria:

* Inability to independently complete the questionnaire/training due to sensory, cognitive or motor disabilities.
* Reading ability NOT at 5th grade on the reading subtest of the Wide-range Achievement Test.
Diet and Disease Activity in Patients With Inflammatory Bowel Disease

In addition to a genetic susceptibility, the immune system and the intestinal microbiota, diet is hypothesized to be an important factor in the onset and progression of Inflammatory Bowel Diseases (IBD). Further insight in factors affecting disease activity may contribute to targeted interventions improving disease burden and healthcare costs for these patients. However, well-designed studies exploring the role of diet in the development of exacerbations are hardly available.

The investigators hypothesize that differences in dietary patterns affects the intestinal microbiota composition and thereby contributes to the development of exacerbations in IBD.

Furthermore, a subgroup of patients suffers from malnutrition, although the exact prevalence is unknown since simple noninvasive screening tools have not been validated for IBD. The investigators hypothesize that malnutrition is frequently present in IBD patients and associated with dietary intake and disease characteristics.


Eligibility Criteria:
Inclusion Criteria:

* IBD patients, diagnosis based on clinical, endoscopic, histological and/or radiological criteria
* participating IBD-SL cohort

Exclusion Criteria:

* Unable to provide informed consent
EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.

The specific objectives and methods of this project are: (1) To test the feasibility and accuracy of integrating EEG, MECG and EMG for detecting the severity of diseases such as aortic stenosis, heart failure and ischemic stroke. (2) Improve the accuracy of this multi-channel brain-heart-muscle device by using an artificial intelligence auxiliary system. (3) Provide tailor-made interdisciplinary treatment strategies for patients with different disease states.


Eligibility Criteria:
Inclusion criteria

1. Age≥20 year-old
2. Healthy subjects or patients with A. Metabolic syndrome (MetS) ；B. HF with reduced ejection fractions (HFrEF, defined by left ventricular ejection fraction≤40%) and current or previous symptoms of HF；C. Severe aortic stenosis (defined aortic valve area \< 1.0 cm2 or mean pressure gradient ≥ 40 mmHg), preparing to receive transcatheter aortic valve replacement ；D. Acute ischemic stroke and admitted to stroke intensive care unit (ICU), within 24 hours after onset

The criteria of MetS includes:

1. Abdominal obesity: waist circumference (for Asians) ≥ 90 cm in men and ≥ 80 cm in women;
2. Hyperglycemia: serum fasting glucose level ≥ 100 mg/dl, or receiving drug treatment for elevated blood sugar;
3. Reduced high-density lipoprotein cholesterol (HDL-C): serum HDL-C \< 40 mg/dl in men and \< 50 mg/dl in women or on cholesterol drug treatment;
4. Elevated triglycerides: serum triglyceride ≥ 150 mg/dl or on drug treatment of hypertriglyceridemia;
5. Hypertension: systolic blood pressure ≥ 130 mmHg, diastolic blood pressure ≥ 85 mmHg, or on antihypertensive drug treatment.

Exclusion criteria:

1. Under treatment for malignancy
2. Currently receiving immunosuppressants
3. Modified Rankin Scale (mRS) ≥2 prior to the stroke
4. Symptomatic HF in patients with acute ischemic stroke
5. Unable to perform neurocognitive function test
6. Unable to evaluate the physical activity using questionnaire or 6-minute walk test
7. Unable to cooperate with examinations using 3E combo machine.
Treatment of Postviral Olfactory Dysfunction

A decreased sense of smell (hyposmia) is often caused by viral infections, such as COVID-19. Today, the only recommended treatment for hyposmia is olfactory training, a time consuming method with limitations in terms of both compliance and effect. The aim of this study is therefore to evaluate, as well as optimize, a new treatment method for olfactory loss.

Hyposmic participants will be recruited and randomized into two different treatment conditions. One group will do regular olfactory training and the other will do passive olfactory training with scented nose plugs. The training will be conducted in the home of the individual monday through friday for two consecutive months. Subjective and objectvie measures of olfactory problems will be assessed before and after treatment, as well as subjective measures related to quality of live and genereal wellbeing.


Eligibility Criteria:
Inclusion Criteria:

* 18 - 65 years old
* Physically and cognitively capable of participating in the study
* Having appropriate olfactory screening test scores (hyposmic)

Exclusion Criteria:

* Anosmics
* Individuals with other diagnoses that could affect the study results
Condylar Segment Repositioning Using CAD/CAM Generated Wafer After BSSO in Skeletal Mandibular Deformity

Maintaining the condylar position after bilateral sagittal split ramus osteotomy (BSSO) is one of the most important aspects in terms of condylar function ,.An altered condylar position can cause internal derangement of the joint, loss of the mandibular angle, increased risk of relapse, condyle sagging, and impaired masticatory function.

In previous years, a great deal of attention has been paid to maintaining the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported and could be divided into manual/empirical methods, conventional methods , navigation, and sonographic monitoring, Computer guided methods which is more accurate than other methods

unpredictable condylar position after orthognathic surgery, will lead to malocclusion, derangement of the condylar surface, condylar resorption, condylar sag, distraction of the condyles from the fosse. In previous years, several authors had been adopted several techniques to maintain the preoperative condylar position during orthognathic surgery. Numerous condylar positioning methods have been reported which could be divided into conventional techniques (manual maneuvers or aiding tools), Extra and intra oral navigational techniques , surgeons had been utilized these techniques in condylar repositiong after BSSO but it was time and effort consuming and sometimes it was inaccurate. the aim for conducting the research is accurate positioning of condyle three dimensionally to minimize effort and operating time of surgery .

Eligibility Criteria:
Inclusion Criteria:

* Age of the patient above 18 years
* Patients needs bilateral sagittal split osteotomy
* All patients are free from any systemic disease that may affect normal bone healing
* Sufficient dentition to reproduce the occlusal relationships
* Patient's consent to participate

Exclusion Criteria:

* Patient with TMJ Disorders
* Patients with any systemic disease that may affect normal healing
* Intra-bony lesions or infections that may interfere with surgery.the presence of
* Previous orthognathic surgeries