cyrilzakka/clinical-trials huggingface dataset:
Effect of Branched-chain Amino Acids (BCAA) to Muscle Cramps in Patients With Cirrhosis

The goal of this randomized controlled trial is to compare the efficacy and safety of branched-chain amino acids (BCAA) versus placebo for treating muscle cramps in cirrhotic patients. The main questions it aims to answer are:

* Compared the effect of BCAA versus placebo on muscle cramp frequency in cirrhotic patients
* Compared the effect of BCAA versus placebo on muscle cramp duration and severity in cirrhotic patients
* Compared the effect of BCAA versus placebo on quality of life in cirrhotic patients with muscle cramps Participants with cirrhosis who have experienced muscle cramps at least once per week will be randomized to receive either a placebo or 12.45 grams of BCAA orally per day for 12 weeks.

Cirrhosis is a late-stage of fibrosis of the liver caused by many forms of liver disease. Muscle cramps are visible or palpable involuntary contraction part of the muscle. The prevalence of cramps in cirrhosis varied range from 31-78%. The pathophysiology of cramps in cirrhosis was explained by multiple mechanisms such as energy metabolism, nerve function, and plasma volume. Cramps significantly diminished the quality of life in cirrhotic patients.

Many drugs, vitamins, and minerals were studied for treating cramps in cirrhosis in previous studies but no clinical improvement, good randomized control studies, or side effects.

Branched-chain amino acids (BCAA) had been developed to correct this amino acid imbalance and helped to decrease the frequency of cramps and improve the quality of life in cirrhotic patients from previous studies but there were no control groups and a small number of patients were included. The aim of this study was to evaluate the efficacy and safety of BCAA for controlling muscle cramps in cirrhotic patients.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Muscle cramp ≥ 1 time per week
* Confirmed cirrhotic status (radiologic finding compatible with cirrhosis or liver stiffness measurement ≥ 12.5 kPa by transient elastography method or pathological confirm of cirrhosis)

Exclusion Criteria:

* Allergy to BCAA
* Overt hepatic encephalopathy
* Hepatorenal syndrome
* Severe renal insufficiency; eGFR \< 30
* Heart failure
* Peripheral arterial disease
* Active malignancies beyond hepatocellular carcinoma
* Heavy alcohol drinking (\> 21g/day for men and \>14g/day for women)
* Pregnancy or lactation
* Current use of BCAA within 3 months
* Recent adding or titrating diuretics within 4 weeks
* On current medications for muscle cramp relief such as vitamin E, taurine, carnitine, narcotic pain medications, baclofen, methocarbamol, other muscle relaxers, NSAIDs, or other antispastic agents.
Running Retraining to Minimize Braking Forces

The proposed research study aims to investigate whether a gait modification training program to decrease peak braking forces during the stance phase of running will result in a reduction in impact loading and the incidence of running-related injuries among recreational distance runners.


Eligibility Criteria:
Inclusion Criteria:

* Ability to commit to a 15-week half-marathon training program
* Have been running for at least 3 months prior to study commencement
* Have participated in 2 or less half-marathons previously
* Ability to run on a treadmill unaided
* Ability to travel to testing facility for running analysis pre- and post-training program as well as for gait retraining sessions
* Ability to understand written and spoken English
* Meet the screening requirements (display less than -0.27BW mean peak braking force at baseline/screening assessment)

Exclusion Criteria:

* Any lower extremity pathology in the previous 3 months or currently have pain in their lower back or lower extremities while running
* Have undergone hip, knee, or ankle joint surgery
Impact of an Immune Modulator Dimethyl Fumarate on Acute Ischemic Stroke

The investigators conduct this study to investigate whether oral administration of Dimethyl Fumarate, a Food and Drug Administration-approved drug for multiple sclerosis, is safe and effective in in alleviating neurologic deficits in patients with Acute Ischemic Stroke.


Eligibility Criteria:
Inclusion Criteria:

1. \>18 y of age;
2. acute onset of focal neurological deficit consistent with acute ischemic stroke;
3. measurable neurological deficit (NIHSS ≥ 5);
4. anterior-circulation ischemic stroke defined by magnetic resonance angiography (MRA) and Diffusion-Weighted Imaging(DWI);
5. onset of symptom to admission more than 4.5 h and less than 72 h. Patients who arrived within 0-4.5 h poststroke were treated with other medications according to the best accepted medical treatment guidelines.

Exclusion Criteria:

1. Other diseases of the central nervous system
2. There has been neurological disability in the past (mRS score\>2)
3. Difficulty swallowing
4. Arrhythmia, atrioventricular block
5. Use of anti-tumor drugs, other immunosuppressive and immunomodulatory drugs
6. Macular edema
7. MRA shows vertebral basilar artery obstruction
8. Hemorrhagic stroke
9. Patients who are known to have hypersensitivity to dimethyl fumarate or any excipients of this product
10. Pregnant and lactating women
A Clinical Study of a Natural Remedy for Rheumatoid Arthritis vs. Commonly Used Conventional Medications

The purpose of this study is to evaluate the efficacy and safety of a combined therapy for rheumatoid arthritis (RA). The combined therapy contained paeoniflorin (Brand name: Pafulin), which has anti-inflammation properties, and Cervus and Cucumis polypeptide injection (Brand name: Songmeile), which has bone healing, pain relieving, and anti-inflammation properties. The hypothesis is that this remedy, which has long been used by the world's largest RA community, is effective and safe when tested by modern clinical standards and criteria.

This is a double-blinded randomized study on the treatment of rheumatoid arthritis. In particular, patients were randomly assigned to one of the following treatment groups: Paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), Methotrexate (MTX) + Leflunomide (LEF), and MTX + LEF + CCPI. The therapeutic effectiveness was evaluated by the 7 core set measures of American College of Rheumatology (ACR). Adverse effects, their severity, and the evaluators' professional judgments of relationships between the adverse effects and the drugs were documented.

Eligibility Criteria:
Inclusion Criteria:

* age of 18 years or older
* active RA, defined by at least 8 swollen joints and at least 10 tender joints (excluding distal interphalangeal joints)
* an erythrocyte sedimentation rate (ESR) of at least 28 mm per hour
* the 1987 revised American College of Rheumatology (ACR) criteria for diagnosis of RA for at least 6 months
* not use of NSAIDs within two weeks
* agreement to participate in this study.

Exclusion Criteria:

* poor compliance
* severe medical conditions
* abnormalities in liver, or kidney function, or in haematological parameters,
* pregnancy or breast feeding
Resiliency in Total Joint Arthroplasty

The investigators primary objective is to determine how does participation in StreaMD affect patient reported outcomes after Total Hip Arthroplasty (THA) or Total Knee Arthroplasty (TKA)?

Osteoarthritis is a leading cause of disability in the US. By conservative estimates, about 54 million adults in the US have doctor-diagnosed arthritis. The number of people expected to have arthritis by the year 2040 is more than 78 million. Total joint arthroplasty is considered the treatment of choice for end-stage osteoarthritis. Currently, more than 1 million hip and knee replacements are performed each year in the US. By 2030, primary THR is projected to grow 171% and primary TKR is projected to grow by up to 189%, for a projected 635,000 and 1.28 million procedures, respectively. The incidence of pre-operative psychological distress in this group of patients is reported between 30% and 60% and preoperative psychological distress is associated with poorer pain and functional outcomes after surgery. Resilience, characterized by an ability to bounce back or recover from stress, is increasingly recognized as a psychometric property affecting many outcomes' domains including outcomes after TJA. Better resilience could improve patients overall satisfaction with the procedure.

Eligibility Criteria:
Inclusion Criteria:

* All patients aged 18 and older who are receiving a total hip or knee replacement.

Exclusion Criteria:

* Patients enrolled in the MyMobility study
* Patients who do not have cell phones with text messaging capability
* Non-English speaking patients
Motivational Training Program for Pre-service Physical Education Teachers

This study presents the protocol for a non-randomized controlled trial evaluating a motivational-based training program for pre-service Physical Education teachers. The experimental group will participate in a 14-hour training program based on Self-Determination Theory and the circumplex model. The program consists of theoretical and practical training to foster motivating teaching styles and minimize demotivating ones. The control group will follow the standard curriculum of the Master's in Physical Education Teacher Education program without exposure to the specific intervention.

Physical Education Teacher Education is crucial, as it directly influences how pre-service Physical Education teachers will teach, motivate, and engage their future students. However, training programs that foster motivating teaching styles while minimizing demotivating ones remain scarce, particularly during initial teacher education. This study presents the protocol for a non-randomized controlled trial evaluating a motivational-based training program for pre-service Physical Education teachers, grounded in Self-Determination Theory and the circumplex model. The program, embedded in a Master's in Physical Education Teacher Education, consists of theoretical and practical training to foster motivating teaching styles and minimize demotivating ones. The study will involve at least 38 pre-service teachers, divided into an experimental group (n = 19) and a control group (n = 19). The experimental group will participate in a 14-hour training program combining theoretical and practical components. The control group will follow the standard Physical Education Teacher Education curriculum. A quasi-experimental pre-post design with a mixed-methods approach will be used. Quantitative assessments will measure changes in perceived competence, motivation for teaching, and (de)motivating teaching styles, while qualitative focus groups will provide in-depth insights into participants' experiences and program applicability. To ensure objectivity, independent researchers will conduct assessments, and external experts will moderate the focus groups. Findings will contribute empirical evidence on the effectiveness of Self-Determination Theory-based interventions in initial teacher education, informing curriculum development and supporting the advancement of evidence-based pedagogical training in Physical Education.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the Master's in Physical Education Teacher Education at the University of Zaragoza.
* 100% attendance in training sessions (experimental group).
* Completion of questionnaires at three time points (pre-test, intermediate, and post-test).
* Participation in the final focus group discussion.

Exclusion Criteria:

* Failure to complete required assessments.
* Lack of attendance in mandatory sessions.
Description of the Organizational Measures Framing Surgery for Idiopathic Scoliosis in Children and Adolescents - Practice Survey

The pediatric orthopaedic surgeon treats idiopathic scoliosis in children and adolescents using the posterior vertebral arthrodesis technique. This surgery is considered "heavy" by the child and families while it is intended for a healthy population. Through this study to take stock of the measures governing idiopathic scoliosis surgery (pre-operative, intra-operative and post-operative) within the various pediatric orthopedic surgery departments on the French national territory.

The goal is to measure the interest of harmonizing the preparation of orthopedic surgery for idiopathic scoliosis in children and adolescents by implementing a ERAS (Enhanced Rehabilitation After Surgery) protocol nationwide.

Eligibility Criteria:
Inclusion Criteria:

* Paediatric orthopaedic surgeons in the national territory who routinely treat idiopathic scoliosis in children and adolescents and who are members of the Société Française d'Orthopédie Pédiatrique (SoFOP)

Exclusion Criteria:

* Refusal
Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer

This trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. The aim of this exploratory study is to compare the sensitivity of three different techniques (CellSearch®, Parsortix® and SmartCatch®) in detecting circulating tumor cells (CTCs). After the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different CTC detection techniques.

Each patient will participate in the study for one day.

A total of 36 evaluable patients (18 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, RH+/HER2-negative or HER2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment.
2. Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.
3. Age ≥ 18 years and WHO ≤ 2
4. Patient affiliated to Social Security scheme in France.
5. Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.

Exclusion Criteria:

1. Associated pathology(ies) likely to prevent the study procedure from running smoothly
2. Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
3. Patient deprived of liberty or under legal protection (guardianship, legal protection)
4. Patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.
An Epidemiological Survey of Cancer-related Fatigue Among Taiwanese Cancer Patients

The aim of this study is to examine the prevalence, severity, impacts and managements of CRF among Taiwanese cancer patients.

The cross-sectional survey is conducted at oncology inpatients unit and outpatients clinics of hospitals in Taiwan. Furthermore, the results will elucidate not only the epidemiology of CRF in Taiwan, but will supply physicians with more understanding about CRF, and help them to enhance the quality on cancer care to being perfected in the future.

Eligibility Criteria:
Inclusion Criteria:

* (1) Patients who signed the informed consent form
* (2) The age of eligible patients should be \> 20 years old.
* (3) Inpatients or outpatients who have been given a diagnosis of cancer
* (4) Able to communicate verbally and completely fill out the questionnaires

Exclusion Criteria:

* Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires
Evaluation of a Portable Oxygen Concentrator During Ambulation for Patients Who Require Supplemental Oxygen (POC-LEAN)

Prospective randomized study with a cross-over design. Mobi™ is a relatively new POC in the market and thus it is valuable to collect data from COPD patients using supplemental oxygen, and their use on Mobi™. The purpose of the present study is to compare Mobi™ with a continuous flow oxygen cylinder, with SpO2 as the primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female, age ≥ 18 years at the time of signing informed consent.
3. Diagnosed with COPD and currently in a stable state (at least 4 weeks since last exacerbation episode22).
4. Current prescription for long-term oxygen therapy.
5. Participants meet the criteria for pulse-dose portable oxygen delivery, defined as being mobile within the home and the qualifying blood gas study was performed at rest/ awake or during exercise.
6. Participants who can read and comprehend English.

Exclusion Criteria:

1. Clinically unstable, in the investigator's opinion, which might jeopardize the participant's safety or compliance with the protocol.
2. Current oxygen therapy prescription for \>5 L/min continuous flow.
3. Known or suspected contraindication for pulse-dose oxygen.
4. Unable to complete 6MWTs, e.g., unstable angina and myocardial infarction during the previous month
5. Female who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).
Pedal Rate Influence on Oxygen Consumption in Eccentric

Nowadays, ECC exercise can be realized using various modalities that target small or large muscle masses in a segmentary or dynamic way. The training program proposed in this study is realised on an handmade ergocycle which allows eccentric contractions.

With this type of ergometer, O2 consumption (VO2) is three to five fold lower than during an exercise realised at the same power output with a concentric ergocycle. Due to this later propertie, which origins are not yet fully identified, there is an increasing interest to embed ECC in rehabilitation programs.

The investigators hypothesis that a higher pedal rate will induce a lower oxygen consumption, with the same benefits.

This study aims to compare oxygen consumption at two pedal rates : 50 and 80 rotation per minute (rpm).

The ultimate goal is to assess efficacy and tolerance of eccentric training on ergocycle and to enhance comprehension of the physiological mecanisms involved in the lower O2 consumption observed.

The training program proposed in this study is realised on an handmade ergocycle which allows almost pur eccentric contractions.

Fifteen healthy volunteers realize a incremental test until exertion on a concentric ergometer. If the minimal power output of 200W is reached, the volunteers are familiarized with eccentric exercise during several bouts of exercise. This habituation session allows avoiding the secondary muscular effects of high intensity eccentric exercise.

Then, volunteers could take part in a two-stepped eccentric protocol: 1) an incremental test consisting in 3 stages. Each stage lasts 4 minutes.

2) A constant-load test realized at 320W during 6 minutes. Each test is realized twice: at 50 and 80 rpm and sequence is randomly assigned.

\[One step (incremental or constant load) = two tests (50 and 80 rpm)\]

During each step, oxygen consumption is continuously measured, as well as cardiac output and muscular activity and intramuscular oxygen kinetic.

Eligibility Criteria:
Inclusion Criteria:

* - Males
* IMC \<30
* physically active
* Pmax concentric \> 200W
* Pmax \> Pmax théo sédentaire

Exclusion Criteria:

* cardio pulmonary, osteo articulary or muscular diseases
* Eccentric based physical activities or sports (weight liftering, alpine skiing)
Living Well With a Disability Curriculum Adaptation Evaluation Plan

The purpose of this proposal is to implement a joint project with Georgia Southern University and the Effingham County Navigator Team to improve the quality of life of families with a child with a disability in southeast Georgia. The final outcome of this project will be a new curriculum, Living Well Together, which builds on a previous implementation of the Living Well with a Disability curriculum in Bulloch County.

First, parent facilitators will be recruited and matched with their peers. Parent facilitators will be members of the Effingham County Navigator Team with a child with a disability. The peer matching resembles the community lay health worker model. The community lay health worker model will reduce the amount of time needed to meet face to face with families. To begin adapting the facilitator training and curriculum, the program directors will work with representatives from the University of Montana Rural Institute on Disabilities to review and update training materials. A representative from the Rural Institute on Disabilities will deliver an online intensive facilitator training. The facilitator training is approximately 15 hours long. The training includes three major components: peer training, facilitator training, and Master "Train the Trainer" training. The project directors will work with the Effingham County Navigator Team to recruit parents. The Navigator Team will recruit five parents as parent facilitators. The parents will work together with the project directors to deliver the adapted curriculum to participating families. With bi-weekly meetings for 10 weeks between parent facilitators and family participants in the home or another desired location. The project directors have already participated in the facilitator training and will serve as mentors to newly trained facilitators. At the end of the online training session, the parent facilitators will be equipped to successfully implement the Living Well curriculum. The project directors will schedule a working meeting before and after the facilitator training to discuss curriculum changes with the Rural Institute on Disabilities representative. Changes in readability are anticipated since the target audience includes adolescents. Curriculum delivery methods will need tailoring to match a family-based approach including activities to be completed at the home at the family and individual levels for parents, siblings, and children. Both GSU faculty and the Navigator team will lead monthly summary meetings to review the adapted content. These meetings will take place at a convenient location in the community as determined by the Navigator team. Pre and post focus groups will take place before and after these monthly meetings at a convenient locale in the community.

Eligibility Criteria:
Inclusion Criteria

Families of with a child (3-50) with any developmental disability

Exclusion Criteria

Family and child are unable to follow directions and participate in curriculum activities.