cyrilzakka/clinical-trials huggingface dataset:
Spinal Cord Injury - Exercise

Long lasting inflammation in the body is related to cardiovascular and respiratory disease, which are the two most common causes of death in people living with spinal cord injury (SCI). Individuals with SCI have been reported to have higher levels of inflammation when compared to healthy individuals. Exercise is a well-known method to reduce inflammation; however, people with SCI are often inactive. The main goal of this study is to determine whether a 12-week adaptive exercise program can reduce inflammation in people with SCI. Participants will be randomized to start exercise immediately or after a 12-week delay.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide and provision of signed and dated informed consent form
* Age 18-70
* Diagnosis of SCI and post injury ≥ 6 months
* Able to achieve adequate active range of motion at the elbow and wrist (flexion/extension) and able to achieve at least 90° active shoulder flexion, in order to complete study activities

Exclusion Criteria:

* Non-English speaking
* Exercise program participation ≤1 month from study enrollment or any other exercise participation during the duration of the study
* Patients with significant cognitive impairment of any etiology that prevents them from being able to participate
* Patients that were given sternal or spinal precautions that would prevent excessive twisting, bending, overhead reaching and lifting over 10 pounds
* Patients with a history heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion
* Has been diagnosed with autonomic dysreflexia that is severe, unstable, and uncontrolled
* Requires ventilator support
* Spasms that limit the ability of the subjects to participate in the study training as determined by the Investigator
* Pregnant, planning to become pregnant
* Any other medical conditions that could affect their ability to participate in the exercise program (as determined by study investigators)
* Active participation or past participation ≤3 months in any other interventional study.
* Unwilling to participate in all study related activities
Mortality Risk Assessment by Skilled Staff Compared to Existing Validated Tools in Skilled Nursing Departments

Mortality Risk Assessment by Skilled Caregivers Compared to Existing Validated Tools in Skilled Nursing Departments at Shmuel Harofeh Geriatric Hospital

Background The elderly population in Israel and globally is growing, increasing demand for medical services, particularly palliative care. Recommendations from 2016 emphasized the need for geriatric and skilled nursing departments to focus on end-of-life care, but implementation has been limited. High mortality and frequent readmissions are reported in long-term care, yet accurate mortality prediction tools for elderly patients remain limited. Improved mortality prediction can help identify patients who would benefit from palliative care and reduce unnecessary interventions.

Research Objectives

1. Assess life expectancy of patients in skilled nursing departments.
2. Compare the effectiveness of various tools in predicting six-month mortality.

Hypothesis Caregiver assessments will more accurately predict mortality than current validated tools.

Study Design Type: Prospective cohort study. Location: Shmuel Harofeh Hospital

Study Population Approximately 250 patients admitted to skilled nursing departments at Shmuel Harofeh Hospital.

Recruitment Period: Two years. Follow-up Period: Up to one year.

Methods

Epidemiological and clinical data (age, comorbidities, functional and cognitive status, lab results) will be collected. Mortality risk will be assessed using:

1. Validated Tools: Including the MITCHELL scale (for patients with advanced dementia) and the POROCK scale (for institutionalized patients).
2. Caregiver Assessment: Subjective life expectancy estimates by attending geriatricians and nursing staff within three days of admission and again 7-10 days later. An external geriatrician will also provide an assessment based on brief, non-invasive observation.

Data Processing Data will be coded, entered into an electronic dataset, and undergo statistical analysis after collection. No interventions beyond routine care are included.

Ethical Considerations As an observational study without intervention, a waiver for informed consent was granted.

Importance of Research Skilled nursing facilities increasingly need to provide palliative care for elderly patients. This study aims to improve mortality prediction methods, helping to identify patients for end-of-life care, ultimately enhancing care quality, and reducing costs by avoiding unnecessary hospitalizations and treatments.


Eligibility Criteria:
Inclusion Criteria: Patients admitted to skilled nursing departments at Shmuel Harofeh Hospital.

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Exclusion Criteria: Patients admitted for end-of-life care

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Evaluation of the Effectiveness of the Local Application of Lemon in the Prevention of Blisters in Ultra-trail Runners

For more than a decade, worldwide participation in ultra-marathons and ultra-trails (running races longer than the 42.195 km marathon) has been increasing. Although considered benign, blisters are a common problem, with serious consequences and limiting performance.

Although blisters are a major factor limiting endurance performance, they are a reason for only 5.8% of ultra-trail runners to quit.

While equipment is improving and participants are increasing and intensifying their training, there is no consensus on the prevention of blisters in ultra-trail running, even though it is the number one factor limiting sports performance. There are few prospective interventional studies on the prevention of blisters during outdoor activities.

On many running forums, there is the hypothesis that lemon applied to the feet prevents the appearance of blisters. This hypothesis has never been scientifically studied.

The investigators hypothesize that the local application of Lemon allows a reduction in the number of blisters on ultra-trail.

The objective of this Blisters-stop 2 study is to evaluate the efficacy of local application of Lemon in preventing the appearance of blisters.

The patients included will be runners registered in a trail of a distance greater than 40km for whom Lemon will be applied on the friction zones of one foot as a preventive measure (28 days).

The study is coordinated by IFREMMONT and the Pays du Mont Blanc Hospitals and 82 patients must be included in order to obtain statistical significance.

Eligibility Criteria:
Inclusion Criteria:

* Ultra-trail participants with validated registration
* Major (≥ 18 years old)

Exclusion Criteria:

* Presence of blisters or other skin lesions on the feet 28 days before the race
* Amputation of one or two feet
* Allergy to lemon
* Psychiatric disorders making comprehension impossible
* Lack of social security coverage
Sallie Life U Feasibility Study

This feasibility trial explored the usability of the patient-driven chiropractic patient portal, Sallie™ Life U. The study aimed to recruit 30 participants to track their daily symptoms, triggers, and habits over 30 days while completing three questionnaires about their experience with the portal. The first questionnaire was administered after participants created their accounts, the second at the midpoint of tracking (day 15), and the third upon completing the tracking period (day 30). All participation in the study was conducted remotely using the participants' personal devices.


Eligibility Criteria:
Inclusion Criteria:

* Have daily access to technology (smartphone, tablet, or computer)
* Currently receiving chiropractic care (for the purposes of this feasibility study, this requires at least one chiropractic adjustment each month)

Exclusion Criteria:

- Given software restrictions, participants must also be able to read and write in English and not be visually impaired.
Effect of the Consumption of a Fermented Milk Enriched With Plant Sterols

The purpose of this study is to investigate the cholesterol lowering effect of a drinkable low fat fermented milk enriched with plant sterol after 3 and 6 weeks of daily consumption in midly hypercholesterolemic people not treated by statins.


Eligibility Criteria:
Inclusion Criteria:

* male/female subject,
* aged from 21 to 75 years,
* BMI between 19 and 30 kg/m2,
* LDL-cholesterol plasma level between 130 and 190 mg/dL without statin monotherapy,
* stabilized hypercholesterolemia,
* accepting to follow the dietary recommendations advisable for hypercholesterolemic patient (NCEP-ATP III guidelines),
* used to consume dairy products,
* effective contraceptive methods used for female subjects,
* having given written consent to take part in the study

Exclusion Criteria:

* subject with plasma triglycerides (TG) levels ≥ 350 mg/dL,
* having experienced any cardiovascular event in the last 6 months,
* taking any hypocholesterolemic treatment,
* diabetic subject (type I and type II),
* smoking strictly more than 10 cigarettes / day,
* heavy alcohol intake (\> 40 g / day for men ; \> 30 g / day for women),
* presenting known allergy or hypersensitivity to milk proteins,
* known soy allergy,
* refusing to stop the consumption of plant sterols-enriched products (other than the studied product),
* receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters,
* receiving a transplant and under immunosuppressor treatment,
* currently involved in a clinical trial or in an exclusion period following participation in another clinical trial,
* in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject,
* with any kind of disease likely to interfere with the evaluation of efficiency or safety of the product,
* for female subject: pregnancy, breast feeding or intention to be pregnant during the study or subject likely to change her contraceptive method during the study
Compatibility and Immunogenicity of a Short Specific Immunotherapy (SIT) in Contrast to Classic Specific Immunotherapy

We wanted to examine the immunogenicity and safety of a shortened specific immunotherapy in contrast to the standard specific immunotherapy.

Therefore, we challenged 12 patients for 14 weeks with the standard specific scheme and 22 patients for 6 weeks with the shortened scheme.

see above

Eligibility Criteria:
Inclusion Criteria:

* informed consent of patient and/or parents
* age \>6 and \<18 years
* bronchial asthma I° or II°
* allergy on house dust-mite

Exclusion Criteria:

* age \<6 and \>18 years
* vital capacity \<80% or FEV1 \<70%
* pregnancy
* inhalative or systemic steroid use
* bronchial asthma III° or IV°
* heavy exacerbation during the last 3 months
Japanese CTO PCI Expert Registry

The purpose of this study is to establish a consensus of treatment strategy of percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) through patient registry of PCI for CTO performed by Japanese certified operators.


Eligibility Criteria:
Inclusion Criteria:

Patients eligible for PCI

Patients who underwent PCI for CTO lesions that contain the following:

1. Thrombolysis in myocardial infarction trial (TIMI) 0
2. The occlusive period more than 3 months or unknown
3. The main coronary arteries (segment 1-3, 5-8, 11, 13), branches that have large perfusion area (segment 4PL, 9/10, 12) and graft

Exclusion Criteria:

Patients ineligible for PCI judged in clinical practice
Safety and Efficacy Study of TNX-102 SL in Subjects With Military-Related PTSD and Related Conditions

This is a 12-week, multicenter, randomized, double-blind, placebo-controlled, fixed-dose, parallel-group study that will investigate the efficacy and safety of two doses of TNX-102 SL -a sublingual formulation of cyclobenzaprine. Following successful screening and randomization, eligible subjects will return regularly to the study clinic for weekly or biweekly visits for assessments of efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 65 years of age
* Diagnosed with current PTSD as defined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5),
* For patients with a qualifying Index trauma(s) resulting in PTSD that occurred during military service, military contractor, Department of Homeland Security or law enforcement
* Willing and able to withdraw and refrain from specific therapies (ask PI)
* Use medically acceptable form of contraception (female only)
* Signed informed consent

Exclusion Criteria:

* Significant traumatic brain injury
* Severe depression
* Bipolar and psychotic disorders
* Increase risk of suicide
* Significant clinical (cardiac, systemic infection, drug/alcohol abuse) or laboratory abnormalities (including positivity for Hep B, Hep C, HIV)
* Unable to wash-out specific medications (ask PI)
* History of violent behavior within past 2 years, unrelated to work duties
* History of drug or alcohol abuse within past 6 months
* Positive illegal substance test
* Known hypersensitivity to cyclobenzaprine
* Others: seizure disorders, uncontrolled sleep apnea, BMI\>40
* Participation in an investigational study in past 30 days
* In the process of litigating for compensation for a psychiatric disorder
* Females that are pregnant or breastfeeding
Healthy Volunteer Study

The study will recruit healthy volunteers to undergo the iontophoresis procedure using the Acclarent Iontophoresis System with Headset.


Eligibility Criteria:
Inclusion Criteria:

* At least 2 years old

Exclusion Criteria:

* Pregnant or lactating females
* Subject with a history of sensitivity or reaction to lidocaine, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the drug solution
* Significant atrophic or perforated tympanic membrane
* Otitis externa
* Damaged or denuded skin in the auditory canal
* Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
* Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
* Evidence of Otitis Media at day of procedure, or within the past three (3) months prior to procedure
Ischemic Stroke in Chinese Young Adults

Stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of \<5% of all ischemic strokes.

Currently, stroke is the fifth leading cause of death in the United States and the leading cause of disability. However, in China, stroke is one of the most frequent causes of death and chronic disability. Ischemic strokes in adults younger than 45 years of age were regarded as a relatively uncommon event in the proportion of \<5% of all ischemic strokes. Our study aimed to evaluate some Biomarkers Underlying in Ischemic Stroke in Chinese Young Adults.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 45 years of age with a first ever ischaemic stroke are eligible for this study from the Department of Beijing Chaoyang Hospital between January 1, 2016 and December 31, 2016.
* All patients were defined as a sudden loss of global or focal cerebral function that persisted with a probable vascular cause for 24h and confirmed by brain CT or MRI.

Exclusion Criteria:

* The exclusion criteria will include patients with intracranial lesions or cerebrovascular disease (including cerebral venous sinus thrombosis)
* History that have caused sequelae, such as movement disorders, mood disorders, cognitive dysfunction or speech problems; or individuals who are pregnant or breast feeding.
* Patients with serious diseases that are related to the heart, liver, kidney or haematopoietic system will not be allowed to participate.
Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) of Cervical Intraepithelial Neoplasia (CIN) Grade 1

The study will examine the effect of HAL vs placebo photodynamic therapy of low-grade cervical precancerous lesions (dysplasia) in women.

Low-grade cervical intraepithelial neoplasia (CIN1) is caused by persistent HPV infection and may worse case develop into cancer. In most cases both the virus infection and lesions (CIN1) regress spontaneously, but must be followed up with gynecological examinations to ensure normalization. If further persistent disease and worsening to precancerous lesions (CIN2-3), the usual treatment is surgery, where one removes the tissue in the cervix where the CIN lesions are.

In this research study we will evaluate a new non-surgical treatment for CIN1 using hexaminolevulinate (HAL) photodynamic therapy (PDT). HAL PDT is the combination of a medication and a specific type of light to activate the drug. HAL PDT selectively removes CIN lesions while preserving normal tissue, thus this may be an alternative to frequent gynecological consultations and local surgery that may have undesirable side effects.

Eligibility Criteria:
Inclusion Criteria:

* Satisfactory colposcopy examination
* Negative endocervical canal by colposcopy
* Ectocervical CIN1 as verified by local pathologist (biopsy).
* Colposcopical visible lesion at visit 2, before photoactivation
* Written Informed Consent signed
* Age 18 or above

Exclusion Criteria:

* Previous treatment of CIN or invasive disease or suspicion of either micro-invasive or invasive disease
* Malignant cells on cytology or histology
* Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology
* Suspicion of endocervical disease on colposcopy
* Current pelvic inflammatory disease, cervicitis, or other gynecological infection as per colposcopy and clinical examination
* Known or suspected porphyria
* Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
* Use of heart pacemaker
* Pregnancy
* Nursing
* Childbirth or miscarriage within six weeks of enrolment - Known
* Participation in other "competitive" clinical studies either concurrently or within the last 30 days
* Risk of poor protocol compliance
* Not willing to use adequate birth control from screening until last PDT
* Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
Feasibility of Intermittent Fasting During Chemotherapy

The goal of this randomized controlled parallel group trial is to examine if fasting before and after chemotherapy is safe, feasible and acceptable. The study population will include patients with either Hodgkin lymphoma or Diffuse Large B Cell Lymphoma.

The main questions aimed to answer are:

Whether fasting during chemotherapy is safe for patients, whether it is feasible to implement in a clinical setting, and whether patients find it acceptable.

We also want to examine a number of patient-reported outcome measures regarding health status and quality of life, such as dietary intake and adverse events from chemotherapy.

Researchers will compare fasting to standard treatment.

Participants will:

* Fast 24 hours before and 24 hours after chemotherapy in addition to standard treatment or receive only standard treatment
* Keep a diary of their dietary intake 24 hours before and 24 hours after chemotherapy
* Keep a diary of their dietary intake for three consecutive days between chemotherapy cycles
* Answer questionnaires/questions in relation to side effects from fasting, side effects/adverse events of chemotherapy, quality of life
* Take bioimpedance analysis (including body mass index and body composition)
* Take blood- and feces samples


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with diffuse large B-cell lymphoma planned to receive R-CHOP (rituximab, vincristine, doxorubicin, cyclophosphamide, and prednisolone) and Hodgkin lymphoma receiving ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine)
* Age ≥ 18 years
* ECOG status 0-2
* Normal weight and overweight (BMI ≥ 18,5 kg/m\^2)

Exclusion Criteria:

* Receiving concurrent radiation therapy and/or treatment
* Other concomitant disease that may make intermittent fasting complicated such as diabetes mellitus
* ECOG status: \> 3
* BMI \< 18,5 kg/m2
* Age \> 80 years
Cellulite and Magnetic Resonance Imaging

The purpose of this study is to compare the anatomy of subcutaneous structures in areas with and without cellulite on the buttocks of same subjects with a non invasive technique, Magnetic Resonance Imaging.

A cross-sectional study was performed at a single center, in accordance with good clinical practice. Thirty women aged 18 to 50 were included in this study. An experienced dermatologist evaluated all of the subjects in a standing position, with relaxed gluteus muscles, using the CSS classification. An area with cellulite and another without cellulite on the contralateral buttock were selected. The area with cellulite had an evident depressed lesion, whereas the area without cellulite had no depressed or raised lesions, The selected cellulite depression was marked with a positive symbol using a skin marking pen.

Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent;
* Subjects agreeing to take part of all procedures of the study, after being fully informed on the objectives and nature of the investigations;
* Healthy female subjects over 18 years;
* Subjects presenting cellulite on the buttocks;
* Medical history and physical examination which, based on the investigator's opinion, do not prevent the patient from taking part in the study and use the product under investigation;
* Female subjects of childbearing age should present a negative urine pregnancy test and should be using an effective contraceptive method (3 months before the enrollment until the end of the study);
* Availability of the subject throughout the duration of the study (180 days);
* Subjects with sufficient schooling and awareness to enable them to cooperate to the degree required by this protocol.

Exclusion Criteria:

* Pregnant women or women intending to become pregnant during the study (next 3 months);
* Subjects participating in other clinical trials;
* Any condition that, in the opinion of the investigator, can compromise the evaluation of the study.