cyrilzakka/clinical-trials huggingface dataset:
Use of Coconut Nourish and Queen Garnet Plum to Improve Health in an Elderly Population

The purpose of this study is to identify whether the combination of coconut Nourish and Queen Garnet plum are able to attenuate ageing-related complications, including muscle mass loss and inflammation. The study endpoints will measure muscle mass as the primary endpoint with blood lipids, glucose, blood pressure, and inflammatory markers serving as some of the secondary endpoints. As the two products are rich in dietary fibre and anthocyanins, respectively, the study outcome will help to understand role of these dietary components in improving complications that are seen quite frequently in elderly population.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years and above
* Able to give written informed consent
* Able to read, write and speak English
* Body mass index less than or equal to 30 kg/m\^2
* Either do not suffer from a chronic disease or, if suffering from a chronic disease, then key parameters (blood pressure, blood lipids concentration and blood glucose concentrations) are within the normal physiological range
* Either take no chronic medication or have been treated with a stable dosage of medication for at least 3 months as confirmed by family physician.
* Either take no supplements, or have been utilizing supplements in a stable and consistent dose for at least 3 months, and plan to continue taking a stable and consistent dose throughout the entire study.

Exclusion Criteria:

* Smokers
* Consumption of more than 2 alcoholic drinks/day, or \> 14 alcoholic beverages a week, or history of alcoholism or drug dependence
* Uncontrolled hypertension, recent stroke or myocardial infarction, hypothyroidism, diabetes mellitus or kidney disease
* Major disability or disorder requiring continuous medical attention and treatment such as chronic heart failure, liver disease, renal failure or cancer, chronic infections or major surgery within 6 months prior to randomization
* Despite taking medication, do not have values for key parameters (blood pressure, blood lipids concentration and blood glucose concentrations) within normal physiological ranges
* Fasting glucose ≥ 5.6 mmol/L
* Triglycerides ≥ 1.7 mmol/L
* Systolic and diastolic blood pressures ≥130/85 mmHg
* High-density lipoprotein cholesterol ≤1.0 mmol/L
* Have gained or lost \>10 lbs in the previous 3 months, or plan to lose weight at any time during the study
* History of allergy to coconut, plum, plain flour, butter or milk
* Any planned surgeries during the study
Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Suzetrigine (SUZ) in participants with pain associated with diabetic peripheral neuropathy (DPN).


Eligibility Criteria:
Key Inclusion Criteria:

* Body weight greater than or equal to (≥) 45 kilogram (kg)
* Body mass index (BMI) ≥18.0 to less than (\<) 40.0 kilogram per meter square (kg/m\^2)
* Diagnosis of diabetes mellitus type 1 or type 2 by glycosylated hemoglobin A1c (HbA1c) ≤9% and the presence of bilateral pain in lower extremities due to DPN
* Weekly average of daily NPRS score ≥4 and less than or equal to (≤) 9 with limited variation in the 7-day Baseline Period

Key Exclusion Criteria:

* More than 3 missing daily NPRS scores during the 7-day Baseline Period
* Participation in a previous study in which the participant received SUZ
* Any sensory abnormality (excluding DPN) as pre-specified in the protocol

Other protocol defined Inclusion/Exclusion criteria may apply.
Pyrotinib After Trastuzumab-based Adjuvant Therapy in Patients With HER2-positive Breast Cancer

This trial is a multicenter, open-label, phase II trial conducted at 23 centers in China. High-risk HER2 positive patients receive pyrotinib 400mg/day for one year or half year for extented adjuvant therapy.

Patients must meet one of the following criteria: N stage ≥1; T stage ≥2; did not achieve pathological complete response (pCR) after neoadjuvant therapy; had pCR after neoadjuvant therapy but with tumor size ≥ 5cm or N stage ≥2; or tumor size less than 2cm but with high Ki67; histologic grade 3 or with lymph node micrometastasis.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 18-75 years old
2. HER2 positive breast cancer
3. ECOG PS 0-1
4. Known hormone receptor status
5. Completed 1 year of trastuzumab-based adjuvant therapy within 6 months
6. Patients at high risk

Exclusion Criteria:

1. Serious heart disease or discomfort
2. Inability to swallow, intestinal obstruction, or the presence of other factors that interfere with drug administration and absorption
3. Known allergic history of drug components of this regimen
4. A history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation
5. Pregnant and lactating female patients
CoV-Hep Study: Regional Anticoagulation Modalities in Continuous Venous Venous Hemodialysis in Patients With COVID-19

Since the emergence of the new strain of betacoronavirus (SARS-CoV-2) and its important clinical repercussions, it has been described that patients with its associated pneumonia (COVID-19) have high rates of thrombotic events, including reduction in the dialyzers patency when undergoing renal replacement therapy. Several strategies for preventing the early loss of dialysers are described, and regional anticoagulation based on citrate is the preferred modality for preventing this complication. On the other hand, in patients with SARS-CoV-2 there are already descriptions of endothelial inflammation and activation of the coagulation cascade, including studies demonstrating the benefit of heparinization of these patients. Thus, this study aims to compare two different anticoagulation strategies in patients infected with COVID-19 with continued venovenous hemodialysis (CVVHD). From the indication of CVVHD, patients will be screened according to eligibility criteria and, if they fit these parameters, they will be randomized into two groups: Group A - Standard regional anticoagulation based on Citrate associated with infusion of low doses of unfractionated heparin 10ui/kg/hour and Group B - Standard regional anticoagulation based on Citrate only. Patients will be randomized in blocks and followed for 72 hours. The primary endpoint is dialyzer patency at the end of 72 hours of clinical follow-up. Secondary objectives will be mortality, bleeding rate, drop in hematimetric indices, urea sieving, filter time in hours, down time of therapy, system and dialyser pressures (PBE and PTM). All patients will undergo a standard procedure with a prescribed dose of 30mL/Kg/H, blood flow of 150mL/minute and polysulfone dialyzer.

After randomization, patients will be allocated to one of two groups:

Control group (n = 45): patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l. The dialysis system pressures, dialyzer patency and duration and bleeding rate will be assessed for 72 hours;

Intervention group (n = 45): patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l associated with unfractionated heparin at 10U / Kg / h. The dialysis system pressures, dialyzer patency and duration and bleeding rate will be assessed for 72 hours.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed or probable SARS-CoV-2 infection;
* Presence of acute kidney injury with indication and agreement between ICU and nephrology teams for the introduction of renal continuous venous venous hemodialysis.

Exclusion Criteria:

* Hypersensitivity to any of the substances used in the study (Citric acid dextrosol 2.2% and unfractionated heparin);
* Previous diagnosis of coagulopathy or thrombophilia;
* Contraindication to the use of unfractionated heparin by the assistant team;
* Risk of citrate poisoning - (Lactate\> 30mg / dL, RNI\> 2.5, Total bilirubin\> 15mg / dL);
* Pregnancy
Efficacy of Prophylactic Epinephrine Solution Injection in Prevention of Delayed Post-sphincterotomy

Bleeding is the most frequently reported serious complication of endoscopic sphincterotomy, and severe bleeding has occurred in about 1% to 2% of patients. Endoscopic injection of epinephrine is the most commonly used, effective, and least expensive method for the management of post- sphincterotomy bleeding. However, the efficacy of prophylactic saline-epinephrine solution injection to prevent delayed EST bleeding when transient bleeding During ERCP has not been established.

Backgroud:

Bleeding is the most frequently reported serious complication of endoscopic sphincterotomy, and severe bleeding has occurred in about 1% to 2% of patients. Endoscopic injection of epinephrine is the most commonly used, effective, and least expensive method for the management of post- sphincterotomy bleeding. However, the efficacy of prophylactic saline-epinephrine solution injection to prevent delayed EST bleeding when transient bleeding During ERCP has not been established.

Study Rationale:

The hypotheses of the study is the prophylactic saline-epinephrine solution injection affects incidence of delayed post-EST bleeding.

Study Design:

A single blinded parallel group, multiple center, randomized controlled trial. The sample size is estimated 400 (200 in injection group and 200 in non-injection group), The primary outcome is the rate of delayed EST bleeding within 30 days of ERCP.

Study Objectives:

Primary objective: the rate of post-EST bleeding within 30 days of ERCP Secondary objectives: the rate of post-ERCP advese effect, the increasing procedure time because of hemostasis, the need for angiographic/endoscopic hemostasis times.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 years or older.
* Ability to give informed consent.
* An naive major papilla.
* Transient bleeding after endoscopic sphincterotomy
* Bleeding less than 30 secs when end of procedure

Exclusion Criteria:

* Prior endoscopic sphincterotomy.
* Thrombocytopenia (platelets \<50,000/mm3).
* Liver cirrhosis (Child A-C)
* CKD stage 4-5 and dialysis.
* Allergy to epinephrine
* Prolonged PT/APTT (INR\>1.5)
* Had exposure any antithrombotic or antiplatelet agent in recent 7 days and/or will take those agents in one month after EST
* Ampulla Vater tumor
* Active GI bleeding
* Pregnancy
* Limited visibility when immediate bleeding after sphincterotomy
* Still bleeding after 30 secs when end of procedure
* Recurrent bleeding during ERCP
HIV Adherence Bottle Intervention Trial

This is a randomized study for participants treated with tenofovir-based antiretroviral drug regimens with a history of suboptimal adherence (detectable HIV RNA twice over the last year). Eligible participants are enrolled, receive routine adherence counseling and are randomized to receive an AdhereTech "smart pill bottle" or not (open label). The "smart pill bottle" quantitates the number of tenofovir-containing pills taken and sends this to a centralized server; if a dose is missed, the participant is contacted by either phone or text. Participants are assessed at baseline and weeks 4, 8, and 12 for tenofovir diphosphate (TFV-DP) levels (by plasma and dried red blood cell spots), HIV RNA level, and adherence using a standardized questionnaire. Primary outcome is change in TFV-DP levels from baseline in the 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected
* Taking a tenofovir-containing antiretroviral regimen for HIV treatment
* Documented suboptimal adherence (2 HIV RNA levels documented above the level of detection, i.e. not suppressed, on 2 occasions over the prior 52 weeks

Exclusion Criteria:

* Plans to change the current HIV drug regimen
The Effects of Exercise on Gait Characteristics, Balance, and Performance in Patients With Normal Pressure Hydrocephalus

The goal of this study is to investigate effect of exercise program on balance, gait and performance in patients with normal pressure hydrocephalus applied with lumbar puncture. The main question it aims to answer are:

* Home based exercise program effective on balance, gait and performance
* Telerehabilitation exercise program effective on balance, gait and performance Researchers will compare home based exercise group, telerehabilitation group and control group to see if difference in terms of balance, gait and performance


Eligibility Criteria:
Inclusion Criteria:

* Age 60-90 years old
* Fulfilling the following clinical criteria for iNPH, as proposed by the Relkin and colleagues
* Able to walk independently (without physical assistance from a person and/or a device)

Exclusion Criteria:

* Patients who had severe physical disability or immobility, major primary psychiatric disorders (eg, schizophrenia, bipolar disorder), unstable major medical illnesses (eg, acute coronary syndrome, respiratory failure), acute cerebrovascular disease, severe visual or hearing impairments were excluded.
* Patients with diagnosis of seconder normal pressure hydrocephalus were also excluded.
Mental Health and Well-being of People Who Seek Help From Their Member of Parliament

This is an observational study to assess the prevalence of common mental disorders and alcohol use disorders in a population of individuals seeking help from their Member of Parliament (MP) in the UK.

Members of Parliament (MP) in the United Kingdom (UK) represent the interests of their constituents. Constituents may contact their MP for assistance if they feel that they have been treated unfairly by a government department or agency, have concerns relating to their local area, or are wanting support from their MP for a campaign they are involved in. In order to fulfil their duty to constituents, MPs hold regular surgeries which allow anyone with a concern to meet with them to discuss the issue in question further. Given the role of the MP in representing people who may be in the midst of stressful events, such as a dispute, it is possible that mental health problems may be more prevalent in this population. However, at present MPs are not given any additional training in recognising mental distress, and may not know how to appropriately sign-post people to appropriate supportive services, nor do MPs receive advice in supporting such individuals. To the best of the investigator's knowledge, there have been no prior studies in this area. The findings of this study will inform initiatives to improve MP working practices, to and raise awareness of the mental health challenges faced by their constituents, with the aim of better meeting the mental health needs of constituents who attend MP surgeries in the future.

Eligibility Criteria:
Inclusion Criteria:

* Attending selected MP surgeries (e.g. in Central Suffolk \& North Ipswich)
* Over the age of 18
* Must be able to complete paper or online questionnaires.
* Have consented to take part in the study

Exclusion Criteria:

- Unable to complete questionnaires on their own/ unaided.
Evaluation of the Ovarian Reserve in Patients Who Hypogastric Arteries and or Uterine Arteries Had Been Ligated

Patients who hypogastric arteries and/or uterine arteries had been ligated will be evaluated in terms of ovarian reserve markers such as anti-mullerian hormone levels, ovarian volumes, antral follicule count, follicule stimuli hormone and estrogen levels. Investigators will search their archives for finding suitable patients for study. Investigators will especially notice being at least 6 month time of interval between surgery and evaluation time. Ultrasound examination and taking blood sample will be performed on 2nd or 3th day of menstrual cycle. These results will be compared with normal postpartum women's results. It will be evaluated that there is or not any effect of the hypogastric arteries and/or uterine arteries on ovarian reserve


Eligibility Criteria:
Inclusion Criteria:

* Patients had been ligated hypogastric and/or uterine arteries
* Patients are in 6 month period after surgery
* Without performed hysterectomy
* No older than 40 years old
* No history about endocrinopathy which have an effect upon ovarian reserve

Exclusion Criteria:

* Patients had been made other gynecologic surgery such as fallopian tube ligation and hysterectomy etc.
* Patients are older than 40 years old
* Patients use drugs which have an effect upon ovarian reserve
* Patients have diseases which have an effect upon ovarian reserve such as some endocrinopathy, malign diseases which require radiotherapy and chemotherapy etc.
A Multi-Centre Clinical Study in Spinal Cord Injury Patients in Mainland China and Hong Kong

To establish a solid foundation, e.g. a network and a coordinating centre for testing new SCI therapies in forthcoming randomised controlled multi-centre clinical trials following international standards and guidelines.

This is a multicentre, observational, registry study of outcome data on SCI patients in Mainland China and Hong Kong. The target population consists of patients who have a SCI, where acute SCI is defined as \<7 days post-injury and chronic SCI is defined as \>12 months post-initial SCI surgery.

A total of 600 patients (300 acute and 300 chronic) will be enrolled from 6 cities in Mainland China (namely: Beijing, Shanghai, Guangzhou, NingBo, Xi'an and Kunming) and Hong Kong. The duration of the study will be one year, with a total of 4 visits.

Eligibility Criteria:
Inclusion Criteria:

General

1. Male or female adult subjects, 18 to 65 years of age
2. Have a clinical diagnosis of SCI, defined by MRI
3. Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures

   Acute SCI Study Group:
4. Has an acute SCI (defined as \< 7 days post-injury)

Chronic SCI Study Group:

4. Has a chronic SCI (defined as \> 12 months post-initial SCI surgery)

Exclusion Criteria:

General

1. Severe head injury
2. Is medically or mentally unstable according to the judgement of the Investigator
3. History of Multiple Sclerosis or peripheral demyelinating disease
4. Likely to have experimental therapy
5. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-56136379 in Healthy Japanese Adult Participants

The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of JNJ-56136379 in healthy Japanese adult participants following oral administration of single doses from 25 milligram (mg) up to 600 mg, in fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be a Japanese participant who has resided outside Japan for no more than 10 years and whose parents and grandparents are Japanese as determined by participant's verbal report
* Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical and surgical history, vital signs, and the results of blood biochemistry, blood coagulation, and hematology tests and a urinalysis performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed/signed by the investigator
* Participant must have a body mass index (BMI; weight in kilogram \[kg\] divided by the square of height in meters) of 18.0 to 30.0 kilogram per meter square \[kg/m\^2\], extremes inclusive, and body weight not less than 45.0 kg
* Participant must have a normal 12-lead electrocardiogram (ECG) (based on the mean value of the triplicate parameters) at screening including: normal sinus rhythm (heart rate between 45 and 100 beats per minute \[bpm\], extremes included); QT interval corrected for heart rate according to Fridericia (QTcF) less than or equal to (\<=)450 millisecond (ms); QRS interval less than (\<)120 ms; PR interval \<=220 ms
* A female participant (except if permanently sterile), should have a negative serum pregnancy test at screening and all female participants should have a negative urine pregnancy test on Day -1

Exclusion Criteria:

* Participant with a past history of cardiac arrhythmias (example \[eg\], extrasystoli, tachycardia at rest), history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT Syndrome)
* Female participant who is breastfeeding at screening or pregnant at screening or predose
* Male participant planning to father a child while enrolled in this study or within 90 days after study drug administration
* Participant with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection (confirmed by antibodies) at Screening
* Participant with current hepatitis A infection (confirmed by hepatitis A antibody immunoglobulin M \[IgM\]), or hepatitis B virus (HBV) infection (confirmed by HBsAg), or hepatitis C virus (HCV) infection (confirmed by HCV antibody), or hepatitis E infection (confirmed by hepatitis E antibody IgM) at Screening