cyrilzakka/clinical-trials huggingface dataset:
Compare Pharmacokinetic(PK) Profiles of XZK vs Lovastatin in Healthy Male Volunteers

The objective of this study is to compare laboratory tests profiles of a botanic drug XueZhiKang (XZK) 300 mg capsules versus a marketed drug Lovastatin 20 mg tablets in healthy male volunteers between 18 and 50 years of age.

Twenty (20) healthy male subjects will be enrolled and assigned to either XZK group or Lovastatin group at a 1:1 ratio at one site in the USA.

Eligibility Criteria:
Inclusion Criteria:

* Capable of giving informed consent and complying with study procedures;
* Male subjects between the ages of 18 and 50 years, inclusive;
* Considered healthy by the PI, based on a detailed medical history, physical examination, clinical laboratory tests, 12-lead ECG and vital signs;
* Nonsmoker, defined as not having smoked or used any form of tobacco in more than 6 months before screening;
* Body Mass Index (BMI) of 19 to 32 kg/m2 inclusive and body weight not less than 50 mg;
* Willing and able to adhere to study restrictions and to be confined at the clinical research center.

Exclusion Criteria:

* Clinically significant past history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity;
* History or presence of malignancy other than adequately treated basal cell skin cancer;
* Clinically relevant illness within one month prior to the screening visit or at screening visit that may interfere with the conduct of this study;
* Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG) or hepatitis C antibody;
* A history of seizure. However, a history of febrile seizure is allowed;
* A hospital admission or major surgery within 30 days prior to screening;
* Participation in any other investigational drug trial within 30 days from the last dosing of other trials to screening;
* A history of prescription drug abuse, or illicit drug use within 6 months prior to screening;
* A history of alcohol abuse according to medical history within 6 months prior to screening;
* A positive screen for alcohol, drugs of abuse;
* Tobacco use within 6 months prior to screening based on subject report;
* Subjects with hypersensitivity to lipid-lowering agents;
* Subjects who have participated in a previous clinical study of XZK;
* An unwillingness or inability to comply with food and beverage restrictions during study participation;
* Donation or blood collection of more than 1 unit (approximately 450 ml) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
* Use of prescription or over-the-counter (OTC) medications, and herbal (including St. John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at \< 3g/day is permitted until 24 hours prior to dosing).
Evaluation of Behaviour in Parkinson's Disease. Normal Values in Healthy Subjects

Non-motor symptoms like mood fluctuations and behavioral disorders are frequent in Parkinson's disease. They may be induced by both the pathology and the dopaminergic treatment and must be considered in treatment policies.

Due to their specificity and the absence of an appropriate evaluation tool, behavioral disorders are rarely searched for.

Therefore, investigators developed a scale permitting qualitative and quantitative evaluation of behavior according to the severity of the disorders.

This study aims to define reference values for healthy individuals

The application of the scale includes a semi-structured interview

The ECMP scale consists of 21 items, each of which may be assessed by use of a 5 point scale (not at all - light trouble - moderate trouble - important trouble - severe trouble)

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants without any neurologic disease
* Men and women from 25 to 75 years old
* French mother tong
* without cognitive troubles (MMS ≥ 24)

Exclusion Criteria:

* Subject under legal guardianship
* Pregnant woman or with childbearing potential without contraceptive device
Feasibility of Obtaining ADRCs From Discarded Thermal Burn Eschar Tissue Using Investigational Celution® System

The objective of the study is to assess the logistical and biological feasibility of preparing ADRCs from adipose tissue excised during standard-of-care burn wound excision using the Celution® System for autologous, same-day application to the burn wound.

This study is a non-interventional clinical study. Adipose tissue excised as part of usual care of burn wound that would otherwise be discarded will be collected for processing and analysis. Target population includes patients with a burn injury that requires surgery in which fat excision of approximately 100 g (or more) is anticipated. The scope of the study includes:

* Fat tissue collected from tangential or fascial excision will be manually prepared for processing within the investigational Celution® System
* Adipose tissue will be processed using the investigational Celution® System. ADRC yield and viability will be evaluated using a NucleoCounter® device
* Age, gender, weight, height, location/severity/%TBSA of burn, time/date of burn injury, current stage of health will be collected
* Operational details such as start and stop time of tissue excision, adipose tissue preparation and Celution® processing, cell counting and dose preparation will be collected. In addition, weight of excised tissue prior to and after preparation, weight of adipose tissue processed by Celution Device and ADRC yield and viability will be recorded.
* Several samples will be collected and sent to a central microbiology laboratory for microbiological testing.

Eligibility Criteria:
Inclusion Criteria

1. Males or females ≤ 80 years of age
2. Admission to hospital for acute burn injury
3. Planned escharectomy anticipated to yield at least 100 g adipose tissue according to the treating surgeon's clinical judgment.

Exclusion Criteria

1. Known history of HIV infection, or has active Hepatitis B or active Hepatitis C infection
2. Pre-existing condition requiring current use of immunosuppressive medication or systemic steroids
3. Cancer requiring chemotherapy or radiation within previous 12 months
Pharmacokinetics/Safety of Miltefosine Allometric Dose for the Treatment of Visceral Leishmaniasis in Children in Eastern Africa

This is a multicenter, non-comparative, open-label clinical trial to assess the Pharmacokinetics (PK) and safety of miltefosine using an allometric dose algorithm in the treatment of children with primary Visceral Leishmaniasis (VL) in eastern Africa. Efficacy and Pharmacodynamics (PD) will be assessed as secondary outcomes.

The proposed study aims to assess whether drug exposure in children can be increased to equivalent adult drug exposure by using the miltefosine allometric dose given BID for 28 days in paediatric VL patients aged 4-12y and whether this dose is tolerable. The present study is also expected to provide the basis for minimum time to reach sufficient drug exposure for miltefosine activity to guide optimal treatment duration to be used in combination therapy for visceral leishmaniasis. The PK data will be assessed in this trial using a compartmental population PK approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical signs and symptoms of VL and confirmatory parasitological microscopic diagnosis
* Patients aged \> 4 to \< 12 years who are able to comply with the study protocol.
* Patients for whom written informed consent has been signed by parents(s) or legal guardian
* Weight \< 30 kg

Exclusion Criteria:

* Patients who are relapse cases
* Patients who have received any anti-leishmanial drugs in the last 6 months
* Patients with severe malnutrition (for children aged \<5 years, weight-for-height WHO reference curves by gender, z score \<-3; for children 5-12 years, BMI-for-age WHO reference curves for gender, z score \< -3)
* Patients with positive HIV diagnosis
* Patients with previous history of hypersensitivity reaction to miltefosine
* Patients suffering from a concomitant severe infection such as Tuberculosis (TB) or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication
* Patients suffering from other conditions associated with splenomegaly such as schistosomiasis
* Pregnant or lactating women or female patient in childbearing age (reached menarche)
* Patients with haemoglobin \< 5g/dl
* Patients with White Blood Cells (WBC) \< 1 x 10³/mm³
* Patients with platelets \< 40,000/mm³
* Patients with abnormal liver function (ALT and AST) tests of more than three times the normal range.
* Patients with bilirubin more than 1.5 times the upper normal range
* Patients with serum creatinine above the upper limit of normal (ULN) for age and gender.
* Patients with clinical signs of severe VL disease such as jaundice and bleeding
* Patients who cannot comply with the planned scheduled visits and procedures of the study protocol
Famciclovir in Multiple Sclerosis

This is a proof-of-concept study in 30 patients with established Relapsing Remitting Multiple Sclerosis (RRMS). IMP is Famciclovir. It is a phase II type A open label study. Each individuals participation in the study will last 36 weeks and will be divided into three phases: pre-treatment (12 weeks), treatment with famciclovir (12 weeks), and post-treatment (12 weeks). During the first 12 week phase patients will remain on their usual treatment alone; this will be followed by three months of co-treatment with famciclovir and then followed by a final three months post-famciclovir treatment where participants will continue to take their usual treatment for RRMS. The primary aim is to explore the effect of famciclovir (500mg BD) on Epstein-Barr virus (EBV) shedding in the saliva of patients with MS


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MS
* Males and females aged over 18
* Taking Natalizumab (Tysabri) for the treatment of MS,
* Be able to provide informed consent to take part in this study.
* Female patients of childbearing potential (defined in section 13.4) must be willing to follow protocol contraceptive requirements.

Exclusion Criteria:

* Taking MS disease modifying treatment other than natalizumab (Tysabri)
* On no treatment for MS
* Taking additional immunomodulatory agents (either for MS treatment or other reasons)
* Has received a course of high dose oral or intravenous steroids within 3 months of study entry. The use of low dose (total daily dose \<10mg) and/or the use of topical steroids will not act as an exclusion criteria.
* Taking antiviral or antiretroviral medication for any reason
* Known allergy to penciclovir, acyclovir, valaciclovir or famciclovir
* Taking probenecid
* Significant renal (CKD 3 or 4) and/or liver (ALT\>3x ULN) impairment
* Pregnant, or unwilling to take measures to prevent pregnancy
* Breastfeeding
Lyophilized Black Raspberries in Adults With Familial Adenomatous Polyposis (FAP)

This is a 36 week dietary intervention pilot study to evaluate the effects of lyophilized black raspberries on rectal polyp burden and biomarkers in subjects with FAP. Subjects will undergo a colonoscopy or sigmoidoscopy before study treatment to determine eligibility for the study. Eligible participants will undergo a sigmoidoscopy at 36 weeks after the initiation of study treatment. The size and number of rectal polyps will be documented on a code sheet and by photograph. The efficacy outcome will include the percentage reduction in the number of rectal polyps between baseline and 36 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of familial adenomatous polyposis with at least 5 rectal polyps which are greater than or equal to 2 mm on baseline colonoscopy
* Have an endoscopically assessable rectal segment
* Have not taken NSAIDs or selective COX-2 inhibitors for two months prior to the study and willing to remain off NSAIDs for the study duration.

Exclusion Criteria:

* Known allergies or hypersensitivity to berries
* Diabetes mellitus
* Subjects taking NSAIDs or COX-2 inhibitors who cannot be taken off the medication due to their clinical condition.
Pain Levels and Opioid Usage in Three Nerve Block Cohorts in Primary TKA

The primary objective of this study is to compare effect of combined block of ACB (adductor canal block) with IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block and/or Intra-articular block in immediate postoperative and early postop rehabilitation and pain management in patients undergoing primary TKA. The secondary objective is to review both in-hospital and post-discharge pain levels and narcotic usage of primary TKAs, with a minimum 6-week postoperative follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. Patient is indicated for a primary, unilateral TKA secondary to osteoarthritis.
2. Patient age is 22-89 at time of TKA surgery.
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document.
4. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 22 or over the age of 89.
2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis).
3. Patient is scheduled to undergo a bilateral TKA surgery.
4. Patient is unable to read and speak English.
A Multi-level and Mixed-method Impact Evaluation for the Jockey Club Elders Get Active Fitness Campaign

The goal of this clinical trial is provide a scientific evaluation on the impact of the Jockey Club Get Fitness Campaign to improve the physical capacity and health condition of the community-dwelling older adults after the COVID-19 pandemic. Participants will take part in any of the four care models:

* a box of exercise equipment
* a box of exercise equipment with verbal briefing
* a box of exercise equipment and engage in the 8-week group-based exercise training
* receive the wonderful box of exercise equipment and engage in the 8-week group-based exercise training together with the 6-week behavioral modification

Participants with greater physical dependency, greater chronic disease burden or lower motivation for social engagement will take part in any of the three care models:

* a box of exercise equipment only
* a box of exercise equipment with verbal briefing
* a box of exercise equipment and engage in the 4-session home-based exercise training, together with the 6-week behavioral modification

This clinical trial is a mixed-method study which uses multi-level design to compare the effects of different program care models on behavioral and health-related outcomes among two different cohort of community-dwelling older adults. Exercise level and self-efficacy, physical capacity, social connectivity, geriatric symptoms, and health status are measured. A total of 1300 participants will be recruited. Outcome evaluation 8 weeks after intervention and 3 months after intervention will be included to allow the detection of immediate and long-term program benefits. In-depth individual and focus-group interviews will be conducted to solicit the participants' experience and perceived benefits of the program.

Eligibility Criteria:
Inclusion Criteria:

* Age above 60 years
* Resident of public rental house

Exclusion Criteria:

* Any contraindication to exercise training
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.


Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 yrs with atrial fibrillation (AF) and one or more of the following risk factors for stroke:
* Age ≥ 75, previous stroke
* transient ischemic attack (TIA) or Systemic Embolism (SE)
* Symptomatic congestive heart failure or left ventricular dysfunction with left ventricular ejection fraction (LVEF) ≤ 40%
* Diabetes mellitus or hypertension requiring pharmacological treatment
Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging

Recent research has reported that the maple leaf extract exhibits anti-aging effects by inhibiting elastase activity, thereby preventing the breakdown of elastin and interfering with the formation of wrinkles. Red maple leaf extract contains phenolic compounds known as glucitol-core-containing gallotannins (GCGs) which help reduce the appearance of wrinkles and may decrease skin inflammation, dark spots and pigmentation. The objective of this study is to examine the effects of topical Maplifa on the cosmetic appearance of facial lines, redness and skin tone.


Eligibility Criteria:
Inclusion Criteria:

* Females aged 30-70
* Individuals with Fitzpatrick skin type I-IV

Exclusion Criteria:

* Individuals who have been on any medication that has caused a change in skin pigmentation based on the opinion of the investigator
* Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator
* Individuals who have participated in any other clinical studies using the same test sites (face) and hand in the past 14 days
* Individuals who are pregnant, breast feeding or planning a pregnancy within one month. (There is no concern for risk to fetus but pregnancy can alter skin pigmentation).
* Female volunteers who have started a new hormonal birth control agent or had a change in their hormonal birth control agent within the past 60 days
* Individuals who have had any medical or cosmetic procedure, such as laser resurfacing, or plastic surgery to the test site (face) within the last 6 months. This includes botulinum toxin, dermal fillers, collagen or other similar cosmetic procedure
* Individuals who are currently using or during the past 30 days have used a retinoid such as Retin A, or other Rx/OTC Retinyl A or currently using or during the past 14 days have used hydroquinone (skin lightening)
* Individuals with a known history of hypersensitivity to any ingredients to the cosmetic agent that is being assessed
* Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator.
Compartiendo Salud: Community-Based Intervention for Loneliness

Unwanted loneliness is the gap between the social relations a person has and those they want. The main objective of this research is to assess the impact of a multidimensional community-based intervention on the feeling of unwanted loneliness in the population over the age of 65 years old, who living alone, under social risk or socially isolated living in the La Palma island.

Loneliness is strongly associated with a significant impact on physical health, depression and may in fact be an independent risk factor for depression. Fur-thermore, it is negatively associated with healt problems, like higher blood pressure, poorer sleep, immune responses to stress, and poorer cognition over time in the elderly. The absence of personal connections is related to the adoption of worse life habits and to increased morbidity, with the consequent higher risk of suf-fering cardiovascular and endocrine diseases, mental health pathologies and risk of falls.

The secondary objectives proposed are as follows: Increasing the number of opportunities for social interaction during the intervention; Contributing tools to improve the participants' social skills in the intervention; Fostering self-care and healthy habits in the participants; Reducing maladaptive thoughts; Educating on sleep hygiene measures and non-pharmacological treatments.

The null hypothesis (H0) of this research is that in the population under study, the proposed multidimensional community intervention will not significantly impact the feeling of unwanted loneliness and the health management of these subjects.

Eligibility Criteria:
Inclusion Criteria:

* People over the age of 65 and living alone
* Nursing diagnosis of social risk
* Nursing diagnosis of social isolation

Exclusion Criteria:

* presenting moderate/severe cognitive decline or Pfeiffer scores above 6
* individuals with uncorrected hearing deficits that hinder group interaction
* participants not subjected to the pre- and post-interventions measurements
* participants that do not take part in at least four of the five sessions scheduled
Tegoprazan- Versus PPI-based H. Pylori Eradication

In 2015, vonoprazan, a potassium-competitive blocker (P-CAB), was launched in Japan and used as an alternative for proton pump inhibitors (PPIs) for eradicating Helicobacter pylori. In recent studies, vonoprazan-based triple therapy significantly increased the eradication rate from 72.8% to 87.9%, compared to PPI treatment group. Accordingly, the Japanese Helicobacter treatment guidelines recommend prescribing P-CAB for eradication treatment. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for gastric ulcer treatment. Subsequently, it was proven effective in the treatment of reflux esophagitis compared to PPIs in a non-inferiority clinical trial. P-CAB can increase the gastric pH to 6 or higher within 7 hours after taking tegoprazan. Because tegoprazan can be taken after meals, it can improve patient compliance for H. pylori eradication. Unlike vonoprazan in Japan, however, tegoprazan-based eradication in Korean population was similar to conventional PPI-based treatment. To date, the eradication success rates of PPI and tegoprazan-based triple therapy were 76.4-84.2% and 77.3-84.3%, respectively, and there was no significant difference between the two treatment groups.

Bismuth has long been used as a semi-metal in the dyspepsia and traveler's diarrhea. In H. pylori eradication therapy, several guidelines recommended the addition of bismuth to treatment regimens. Recently, bismuth was added to the 2-week triple regimen to increase the first-line H. pylori eradication rate in countries with high antibiotic resistance. The H. pylori eradication significantly increased from 87.5-88.1% to 95.8-97.3% in a recent study. The odds ratio was 1.63-2.18 in bismuth-added treatment group, compared to no use of bismuth group. In subgroup analysis, odd ratio was 1.66-2.22 in high clarithromycin-resistant areas. However, there was no comparative analysis of PPIs and tegoprazan in a bismuth-added triple therapy.

The investigators aim to evaluate the eradication success rate and treatment compliance between PPI and tegoprazan in first-line H. pylori treatment with adding bismuth.

Eligibility Criteria:
Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding