cyrilzakka/clinical-trials huggingface dataset:
Multiple-dose Pharmacokinetics Study of Tolvaptan Tablets in Chinese Patients With Hepatocirrhosis

For hepatic cirrhosis subjects with ascites or lower extremities, to study Pharmacokinetics, pharmacology, and safety of the drug under fasting condition.

This study is to evaluate the multiple-dose pharmacokinetics, pharmacological actions and safety of Tolvaptan tablets administered orally (15 mg daily) for consecutively 7 days in Chinese adult patients with confirmed Child-Pugh Class B（score 7-9） hepatocirrhosis (accompanied by ascites).

Trial Design:

1. Open, single-center, multi-dose pharmacokinetics study
2. Study population:

   Chinese adult patients with confirmed Child-Pugh Class B (score 7-9) hepatocirrhosis (accompanied by ascites)
3. Dosage and mode of administration of investigational product:

   Oral administration of 1 tablet (15mg) once daily, for consecutive 7 days starting from day 1 of treatment.
4. Study duration:

Screening: 14 days in maximum; Treatment(s): 7 days; Observation: 1 day

Eligibility Criteria:
Inclusion Criteria:

1. Hepatic Cirrhosis with ascites or lower extremities edema
2. Hospitalized patients
3. 18 years old\~75 years old
4. Inform Consent Form Signed

Exclusion Criteria:

1. Patients with any of the following diseases, complications or symptoms:

   * Hepatic encephalopathy (coma degree classification note 1 Grade 2 or above);
   * Malignant ascites;
   * Spontaneous bacterial peritonitis;
   * Likely to have gastrointestinal bleeding during the study period;
   * Heart failure (NYHA Note 2 Class Ⅲ andⅣ);
   * Anuria (daily urine output below 100mL);
   * Dysuria induced by urinary tract stenosis, calculus, or tumor.
2. Patients with any of the following history:

   * With gastrointestinal bleeding within 10 days prior to screening;
   * With cerebrovascular accident within 1 month prior to screening;
   * With gout attack within 1 month prior to screening;
   * With allergy or atopy to benzodiazepine drugs (benazepril hydrochloride, etc.).
3. Patients whose systolic blood pressure is below 90mmHg during screening;
4. Patients with abnormal values in the following lab examination indicators:

   Serum creatinine higher than 2.5 times the upper limit of normal range, serum Na+\>145mmol/L(or higher than the upper limit of normal range), serum K+\> 5.5 mmol/L, uric acid\>476µmol/L, child-Pugh score\>10
5. Patients ineligible for oral medication
6. Patients in pregnancy or lactation; female of childbearing potential not taking contraceptive measures;
7. Patients having taken blood products including albumin products within 4 days prior to application of investigational product;
8. Patients having participated in clinical trials of other drugs within 1 month prior to screening;
9. Patients used to participate in clinical trials of Tolvaptan and take the said drug;
10. Patients determined by the investigator as illegible for the study.
PF-06669571 In Subjects With Idiopathic Parkinson's Disease

This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinical diagnosis of idiopathic Parkinson's disease and presence of at least 2 out of 3 cardinal characteristics (tremor, rigidity and/or bradykinesia).
* Must be Hoehn \& Yahr Stage II-III inclusive and experiencing motor fluctuations in the form of end-of-dose wearing off during the morning hours or early morning akinesia.
* Subjects should be able to recognize their "wearing off" symptoms and verify that they usually improve after their next dose of Parkinson's disease medication. Subjects should be able to recognize drug-induced dyskinesias and verify whether or not they are troublesome.

Exclusion Criteria:

- History or clinical features consistent with an atypical parkinsonian syndrome, (for example: ataxia, dystonia, clinically significant orthostatic hypotension.
Postural Correctors & Activity Trackers in Total Knee Replacement Rehab

* To assess the impact of postural corrector on post-operative knee function and activity
* To evaluate the role of activity tracker in monitoring and enhancing post-operative rehabilitation
* To assess the effects of postural corrector and activity tracker on pain management during rehabilitation

Knee osteoarthritis is a major public health threat. Chronic pain and incapacity related to knee degenerative arthritis (OA) is current among the older population in several developed countries and also the condition is marked by many pathological characteristics, like joint house narrowing and also the formation of osteophytes, Despite the pressing want for effective hindrance and treatment methods, there's a scarcity of comprehensive demographic knowledge on the general prevalence of the un wellness and also the specific subgroups affected

Eligibility Criteria:
Inclusion Criteria:

* Participants who fall in this category will be included in the study.

  * Commercially available devices
  * Post-operative total knee replacement
  * Males and females
  * Age 40 to 60 years

Exclusion Criteria:

* Participants who fall in this category will be excluded from the study.

  * Non wearable devices
  * Patient had been through surgery more than 1 month
  * Patients with any other disorder or disease
Expanded Access Program for R007 (Probucol) Tablets in Adults With Mitochondrial Disease and Chronic Kidney Disease

The purpose of this expanded access program is to enable access to R007 (probucol) tablets for the compassionate treatment of adults with mitochondrial disease who also have chronic kidney disease.

The protocol for this expanded access program provides for the compassionate treatment with R007 (probucol) tablets of adults who (i) have serious or life-threatening mitochondrial disease and also have chronic kidney disease stages 3 or 4, (ii) do not have access to a satisfactory alternative therapy to treat their condition, and (iii) are not able to enroll in a clinical trial.

Eligibility Criteria:
Inclusion Criteria

A patient must meet all of the following criteria to be eligible:

1. Age 18 to 75 years inclusive;
2. Diagnosis of genetically-confirmed mitochondrial disease with a pathogenic mutation or defect in their mitochondrial or nuclear DNA;
3. Diagnosis of chronic kidney disease stage 3 or stage 4;
4. Moderate or severe symptomatology of mitochondrial disease;
5. A sexually-active patient agrees to practice acceptable methods of contraception throughout the protocol period;
6. The patient is not eligible for, or does not have access to, a clinical trial;
7. The patient (or guardian/legal representative) provides signed and dated informed consent to be treated with probucol in accordance with the expanded access protocol.

Exclusion Criteria

A patient who meets any of the following criteria will not be eligible:

1. A known hypersensitivity or adverse reaction to probucol;
2. A medical condition or laboratory result that, in the opinion of the treating physician, will interfere with the safe completion of the protocol;
3. An active fungal infection, acute blood, lung, or bladder infection, clinically significant hepatic or renal dysfunction, and/or viral infection (past or present) that, in the opinion of the treating physician, may have a clinically significant effect on their treatment;
4. Taking an investigational drug other than probucol within one month prior to the first dosing with probucol under the protocol;
5. A medical history or condition that increases the potential for QTc prolongation;
6. A female with a positive pregnancy test result or who is breastfeeding;
7. Has received or is receiving kidney dialysis;
8. Has received or is scheduled to receive an organ transplant;
9. Known or suspected active alcohol and/or substance abuse;
10. A history of or current suicidal ideation, behavior, and/or attempts; or
11. Is unable to swallow tablets or requires gastric feeding.
Using an API to Commercialize an Evidence-Based Weight Loss Intervention

This study will test the effectiveness of a mobile application that uses an Application Program Interface (API) to distribute evidence-based weight loss interventions. Half of the participants will receive this API-based application, and the other half of the participants will use a non API-based application.

The purpose of this study is to test a weight loss app that uses an API to disseminate an evidence-based weight loss intervention. The investigators hypothesize that, over the course of 12 months, participants using the Leaner app will have lost more weight than those in the attention control group.

Participants (n=206) will be randomly assigned to use either the intervention app (intervention arm; n=103) or a weight loss app of their choosing (attention control arm; n=103) for 12 months. Assessments will take place at baseline, and 3, 6, and 12 months.

Statistical analysis: A linear mixed modeling approach will be used to test the hypothesis. Observed weight vs. time plots will be analyzed for all participants to discern general trends in weight change. The model will include an intervention effect, a time effect, an intervention by time interaction, and a random intercept.

In exploratory analysis, investigators will examine weight change across subgroups of interest; investigators will add the subgroup variable and its interaction with the intervention indicator to the primary model. All analyses will be evaluated at the 0.05 significance level.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* between 21-65 years old
* BMI between 25-40 kg/m2
* ownership and use of an Android smartphone during past 6 months with no plans to change phone/service during study
* consent for research team to monitor app utilization

Exclusion Criteria:

* use of weight loss medication
* prior or planned bariatric surgery
* psychiatric hospitalization in past 12 months
* pregnancy, nursing, or planned pregnancy during the study
* history of cardiovascular disease (CVD) event
* self-reported history of an eating disorder
* use of medication for diabetes mellitus
* mobility restrictions for which exercise is contraindicated
* history of a condition (e.g., lithium, steroids, anti-psychotics) that would affect weight measurement, for which weight loss is contraindicated
* current participation in another weight treatment study and/or recent weight loss \>10%
* investigator discretion for safety reasons
Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.

This is a study of the possible effect of two antiepileptic drug on enzymes in the liver that metabolizes a number of drugs. It is a well know fact that carbamazepine induces some of these enzymes and this may reduce the effect of concomitantly administered drugs. Clinical observations suggest that oxcarbazepine does not induce these enzymes to the same degree.

This study directly compares the ability of these two drugs to induce the cytochrome P450 3A4 enzyme, in healthy volunteers using a well defined biomarker reaction of a specific enzyme activity.

It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.


Eligibility Criteria:
Inclusion Criteria:

* BMI \< 30
* Non smoker
* No signs or symptoms of disease by routine laboratory analysis, ECG and physical examination (general appearance assessment; pulmonal and cardiac stetoscopy; abdominal palpation)
* Informed consent

Exclusion Criteria:

* signs or symptoms of disease by routine laboratory analysis, ECG and physical examination
* mental disease
* participation in another clinical trial involving drugs with 3 months of randomization
* donation of more than 500 mL blood within 3 months of randomization
* intake of more than 21 alcohol equivanlents (one normal strength beer contain one alcohol equivalent)per week
Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee.

Patients were enrolled sequentially with 8 patients per cohort, as follows:

Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12

Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.

Eligibility Criteria:
Key Inclusion Criteria:

* Written consent to participate in the study
* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
* Has documented diagnosis of OA of the index knee made at least 6 months prior to Screening
* Currently meets American Collage of Rheumatology Criteria (clinical and radiological) for OA
* Index knee pain for \>15 days over the last month
* Body mass index (BMI) ≤ 40 kg/m2
* Ambulatory and in good general health

Key Exclusion Criteria:

* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
* History of arthritides due to crystals (e.g., gout, pseudogout)
* History of infection in the index joint
* Clinical signs and symptoms of active knee infection or crystal disease of the index knee
* Presence of surgical hardware or other foreign body in the index knee
* Unstable joint (such as a torn anterior cruciate ligament) within 12 months of Screening
* IA corticosteroid (investigational or marketed) in any joint within 6 months of Screening
* IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
* Oral corticosteroids (investigational or marketed) within 1 month of Screening
* Inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of Screening
* Any other IA investigational drug/biologic within 6 months of Screening
* Prior use of FX006
* Prior arthroscopic or open surgery of the index knee within 12 months of Screening
* Planned/anticipated surgery of the index knee during the study period
* Active or history of malignancy within the last 5 years, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ
Effect of SNAGs on Stiffness of Lumbar Stabilizer Muscles

Low back pain is a common health problem worldwide. Epidemiological studies have shown that 70-80% of all people are affected at least once in their lifetime. Although it is common, often the cause of the pain has not been determined and is called 'nonspecific low back pain.

Low back pain has been shown to alter the structure of deep and superficial muscles such as multifidus and erector spinae. However, it has not been fully explained how changes in muscle fiber structure affect the biomechanical properties and functions of the muscle.

There are various manual therapy techniques in the treatment of low back pain. Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name "Sustained Natural Apophyseal Glides" (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment.

Ultrasound shear wave elastography (SWE) provides an advantage since it can quantitatively assess tissue elasticity of in vivo skeletal muscles through non-invasive high-frequency ultrasound waves.

The aim of this study was to investigate the acute effect of Mulligan SNAGs on the stiffness of muscle tissue by using Ultrasound shear wave elastography which is an objective assessment technique.


Eligibility Criteria:
Inclusion Criteria:

* patients who diagnosed with non-specific low back pain
* between the ages of 18-24
* patients who able to perform at least 40° of trunk flexion

Exclusion Criteria:

* patients who obese, pregnant, had specific low back pain
* indication for surgery in the past 1 year
* the trauma of lumbar region, and systemic inflammatory disease affecting this area
* exercise and conventional physiotherapy in the last 6 months
The Effects of Beta-glucan Enriched Oatcake Consumption on Metabolic Disease Risk Factors

The purpose of this study is to determine whether daily consumption of soluble fibre, oat beta glucan (4g), for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease.

The purpose of this study is to determine whether daily consumption oat beta glucan (4g) for six weeks will have any impact on overweight/obese individuals in terms of risk factors used to define metabolic disease.

Oat beta-glucan has been incorporated into a novel oatcake product manufactured by Nairn's Oatcakes Ltd. Consumption of the oatcake products will deliver enough oat-beta glucan to the diet to meet European Food Safety Authority health claims for lowering blood cholesterol and reducing post-prandial glycaemic responses.

Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 years and older
* Waist circumference measurements of ≥94cm for males and 80cm for females, or a body mass index of ≥30kg/m2
* Individuals who are able to provide informed consent

Exclusion Criteria:

* Postmenopausal females
* Smokers
* Individuals who suffer from, or taking medication for, cardiovascular or gastro-intestinal disease
* Impaired glucose tolerance/Diabetes mellitus
* Pregnancy or breastfeeding
* Those who have high dietary fibre intakes (\>20g/day)
* Known food allergies to oats, wheat, lactose, or sesame seeds
Tranexamic Acid in Pediatric Cardiac Surgery

Tranexamic acid(TXA) is an antifibrinolytic agent to reduce blood loss in cardiac surgery. Previous seven RCTs comparing effects of TXA in pediatric cardiac surgery showed conflict results. The reason why they showed mixed results would be the imbalance of patients population with regard to presence of cyanosis. TXA would reduce blood loss in pediatric cardiac surgery with well balanced patients population.


Eligibility Criteria:
Inclusion Criteria:

* children undergoing elective cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* neonate born within 1 month
* preoperative inotropes
* preoperative mechanical ventilation
* preexisting coagulation disorder
* reoperation within 48 hours
* significant liver or kidney disease
* known allergy to TXA
Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Hospitalized Patients

The coronavirus disease (COVID-19) epidemic represents a major therapeutic challenge. The highly contagious severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) and the long duration of the disease have led to a massive influx of patients admitted in health services and intensive care units. To current knowledge, there is no treatment yet that that can prevent infection from SARS-COV-2 virus, nor the disease progression to a severe form.

Daily active smokers are rare among outpatients or hospitalized COVID-19 patients.

Several arguments suggest that nicotine could be responsible for this protective effect thank to the nicotinic acetylcholine receptor (nAChR).

Based on epidemiological data and experimental data from scientific literature, we hypothesize that nicotine could inhibit the penetration and spread of the virus and improve the management of COVID19 , particularly in hospitalized patients to prevent adverse outcomes (death, transfer to intensive care unit, care limitation, mechanical ventilation an high flow oxygen).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients hospitalized for less than 72 hours
* Non-smoking and non-vaping patients (for former smokers or former vapers: abstinent for at least 12 months)
* Documented diagnosis of COVID19
* Lung disease suggestive of COVID-19 on chest scanner or need for oxygen therapy
* Obtaining, informed and signed consent
* Affiliated to a social security scheme or beneficiary of such a scheme (except AME)

Exclusion Criteria:

* WHO 10-point Clinical Progression Scale score \> 5 (patient on non-invasive or mechanical ventilation, patient in need of high-flow oxygen therapy)
* Indication of transfer to intensive care unit (oxygen therapy\> 8 L / min ; out or not carried out due to LATA)
* Current treatment with nicotine replacement therapy, bupropion or varenicline in the last 30 days
* Known addiction problem to alcohol or other substances
* Contraindication for nicotine patches:

  * pregnant or breastfeeding woman
  * lack of effective contraception for women of childbearing age
  * Generalized skin pathologies that may interfere with the use of a transdermal patch
  * stroke or myocardial infarction or acute coronary syndrome for less than 3 months
  * allergy to nicotine or to one of the excipients of the transdermal patch
  * Uncontrolled high blood pressure
  * Unstable or worsening angina
  * Severe cardiac arrhythmia (defined by wearing an automatic implantable defibrillator)
  * Known obliterating peripheral arterial disease
  * Known severe heart failure with an ejection fraction \<30%)
  * Known severe renal (ClCr \<30 ml / min) or hepatic (Child C) impairment
  * Known pheochromocytoma
  * Known uncontrolled hyperthyroidism
  * Esophagitis due to gastroesophageal reflux disease or an active peptic ulcer
* Patient included in another interventional trial evaluating a health product
* Patient under guardianship or curatorship
* Patient deprived of liberty by judicial or administrative decision
Investigation of Popular Recovery Techniques for Ultramarathon Recovery

The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon.

The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon. Participants of the 2015 161-km Western States Endurance Run were randomized to a 20-minute post-race intervention of massage, intermittent pneumatic compression or supine rest. Each subject completed two 400 m runs at maximum speed before the race, and on days 3 and 5 after the race, and also provided muscle pain and soreness ratings and overall muscular fatigue scores before and for 7 days after the race.

Eligibility Criteria:
Inclusion Criteria:

* Entry in the Western States Endurance Run

Exclusion Criteria:

* Failure to finish race