cyrilzakka/clinical-trials huggingface dataset:
Primary Ovarian Insufficiency, Polycystic Ovary Syndrome & the CardiOvascular Risk Profile

The polycystic ovary syndrome (PCOS) is the most common endocrinopathy amongst women of reproductive age. PCOS is associated with various cardiovascular risk factors such as obesity, glucose intolerance, dyslipidemia hypertension and the metabolic syndrome. Whether these increased cardiovascular risk factors result in the development of actual cardiovascular disease in later life remains to be established.

Women with premature ovarian insufficiency (POI), experience menopause prior to the age of 40 years. Women with POI may exhibit dyslipidemia. A young age at menopause has been previously associated with increased cardiovascular morbidity and mortality.

Cardiovascular risk profile will be assessed in women with PCOS and POI \> 45 years of age, consisting of:

fasting serum and urine analyses blood pressure, length, weight, waist circumference, hip circumference ECG carotid intima media thickness cardiac ultrasound

spare serum, plasma and urine will be stored in -80 degrees celsius biobank.

Eligibility Criteria:
Inclusion Criteria:

* age above 45 years

Exclusion Criteria:

* none
Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection.

This is a randomized, double-blind, placebo-controlled study of RP7214 in patients with symptomatic mild SARS-CoV-2 infection, having at least one high-risk feature (e.g., age \> 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity, cancer) for developing severe Covid-19 illness.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide informed consent.
2. Males and females of ≥ 18 years of age
3. Patient with mild COVID-19 infection having ≥ 1 symptoms.
4. Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
5. Patient should have at least one pre-existing high-risk feature for developing severe Covid-19 illness.
6. Ability to swallow and retain oral medication.
7. Male patient who is surgically sterile, or who is willing to agree to use a contraceptive measure.
8. Women of childbearing potential should be willing to use a medically acceptable method of contraception.
9. Willing to receive telephone calls or have videoconferences with study team personnel.
10. Willing and able to understand the nature of this study, comply with the study procedures and follow-up procedures as per the study protocol.

Exclusion Criteria:

1. Patient with asymptomatic Covid-19 infection.
2. Patient who has experienced the onset of any of Covid-19 symptoms \> 5 days at the time of randomization.
3. Moderate to Severe COVID-19 infection
4. Patient with Covid-19 re-infection
5. Subjects who are severely immunocompromised
6. Subjects with autoimmune diseases
7. Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
8. Current use of other DHODH inhibitors including teriflunomide or leflunomide.
9. Patients who are on or immediately require Covid-19 directed treatment such as antivirals, immunomodulatory treatment, convalescent plasma, oral/ intravenous steroids, or monoclonal antibodies at the time of screening.
10. Patients who have had received one or two doses of vaccine for Covid-19.
11. Patients participating in another clinical study or use of any investigational product within 4 weeks or 5 half-lives of the drug, whichever is longer, before the date of dosing
Periodontitis Provokes Retinal Neurodegenerative Effects of Metabolic Syndrome: A Cross-Sectional Study

This cross-sectional study aimed to investigate the retino-choroidal degenerative effects of periodontitis, metabolic syndrome (Mets), and the combination of these diseases using optical coherence tomography (OCT) measurements. Methods: Ninety-two patients selected according to inclusion criteria were divided into 4 groups: systemically and periodontally healthy (Control), systemically healthy periodontitis (PD), periodontally healthy metabolic syndrome (MetS), and periodontitis and metabolic syndrome combined (PD-MetS). The systemic inflammatory-oxidative effects of periodontitis and MetS were biochemically evaluated using serum TNF (Tumor necrosis factor)-α level, IL(Interleukin)-1β/IL-10 ratio, and oxidative stress index (OSI: TOS/TAS). Retinal (AMT, peripapillary retinal nerve fiber layer thickness (pRNFLT), and Ganglion cell and Inner plexiform layers (GCL+T) and choroidal (SFCT) morphometric measurements and vascular evaluations (foveal capillary density) were performed via OCT Angio with swept-source technology.

To the best of our knowledge, although there are many clinical studies on the possible effects of Mets on retino-choroidal layers, there is a limited amount of evidence on the effects of periodontitis which is from an animal study. Moreover, there are no studies on the retinal degenerative effects of the combined presence of periodontitis and Mets. In this context, the present study is unique and based on the hypothesis that the alone or combined presence of periodontitis and Mets may provoke retino-choroidal degenerative changes through systemic inflammatory stress.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with stage III/IV, grade C periodontitis,
* Patients with at least 20 teeth,
* Patients diagnosed with MetS,
* Obese \[waist circumference (WC) 80 cm ≥ for women and 94 cm ≥ for men\], Type 2 (Diabetes Mellitus) DM and hypertensive patients.

Exclusion Criteria:

* Cancer,
* Any autoimmune disease,
* Osteoporosis,
* Active infectious disease (acute hepatitis, tuberculosis, AIDS),
* Vitreoretinal, optic nerve or choroidal vascular disease,
* Acute and chronic ocular diseases (such as cataract, glaucoma, macular degeneration, uveitis, Behçet's, scleritis),
* History of refractive or intraocular surgery,
* Immunosuppressive, oral contraceptive, bisphosphonate and antioxidant drug use,
* Pregnancylactation,
* Smokers.
Minoxidil 1% for Eyebrow Enhancement

The purpose of the study is to compare efficacy and safety of minoxidil 1% versus placebo in enhancement of eyebrows.


Eligibility Criteria:
Inclusion Criteria:

* male or female aged 18-60 years
* hypotrichosis of eyebrows
* healthy
* informed consent obtained

Exclusion Criteria:

* underlying diseases
* alopecia areata or trichotillomania
* thyroid diseases
* pregnancy or breast feeding
* previous eyebrow tattoo, trauma or accident.
* history of eyebrow or hair medications in 6 months
* history of minoxidil or its ingredient allergy
* history of eyebrow surgery.
FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.

The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.

Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.

Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.

As above

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or above.
2. Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
3. Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
4. Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.
5. Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.
6. Signed written informed consent.

Exclusion Criteria:

1. Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
2. Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
3. Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
4. Unable to ingest capsules.
5. Unable to understand written or oral patient information.
Nanoparticles in Blood: Understanding and Controlling Protein Corona for Optimized Nanomedicine

The main objective is to study the effect of engineered nanoparticles SPIONs (superparamagnetic iron oxide) on hemostasis. Nanoparticles will be incubated in blood and platelet aggregation will be measured. In parallel, nanoparticles will also be incubated in blood and then plasma proteins adsorbed on them will be separated and analyzed. The proteins found on the nanoparticles will be linked to the platelet aggregation observed to help developing innovative protein functionalized nanoprobes for optimized nanomedicine.


Eligibility Criteria:
Inclusion Criteria:

* all people

Exclusion Criteria:

* patient under 18 years old, legal protection measure, pregnancy
Safety and Efficacy Study of Bimatoprost to Treat Hypotrichosis of the Eyelashes After Application to the Eyelid Margin

This one-year study evaluates the long-term safety and effectiveness of bimatoprost solution application to the eyelid margin (where the eyelashes meet the skin) to treat hypotrichosis of the eyelashes (inadequate or not enough eyelashes). There will be two different types of subjects participating in the study 1)those with inadequate eyelashes due to natural causes or 2) those with inadequate eyelashes following a complete course of chemotherapy treatment. There will be two treatment periods of six months each. Subjects will receive either the study medication or vehicle in either of the two treatment periods.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who have inadequate eyelashes due to natural causes and are not satisfied with their eyelash appearance.
* For the post-chemotherapy population: subjects who have inadequate eyelashes following a complete course of chemotherapy treatment and are not satisfied with their eyelash appearance, are considered free of cancer and are well enough to complete the study.

Exclusion Criteria:

* Subjects with unequal right and left eyelashes, any eye disease or abnormality, eye surgery, permanent eyeliner, eyelash implants, eyelash extension application.
* Any use of over the counter or prescription use eyelash growth products.
* Subjects requiring eye drop medications for glaucoma.
* Females who are pregnant, nursing or planning a pregnancy during the study or who are of childbearing potential and not using a reliable method of contraception.
An Iliopsoas Plane Block After Total Hip Arthroplasty

Nielsen et al. reported that when iliopsoas plane block was performed on healthy volunteers, the injection solution in Hip MRI was confined to the myofascial compartment, which was known to include all sensory branches of the femoral nerve that control the hip joint. The maximal muscle strength of knee extension did not decrease before and after Iliopsoas plane block in Volunteer. Since there is no clinical study conducted on patients after the volunteer study, the investigators intend to evaluate the analgesic and motor preserving effects of the iliopsoas plane block in a group of patients undergoing total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

1. Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
2. ASA PS 1-3

Exclusion Criteria:

1. Revision total hip arthroplasty
2. Allergy to drugs used in the study
3. Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
4. Estimated glomerular filtration rate \< 30 mL/min/1.73m2
5. Opioid dependence
6. Prolongation of PT and aPTT more than twice the upper limit of normal
7. Pre-existing neurological or anatomical disorders of the lower extremities
8. Serious psychiatric disorders
Treatment and Prevention of Traditional Chinese Medicines (TCMs) on COVID-19 Infection

The aim of this study is to test whether Traditional Chinese Medicines (TCMs) are effective and safe for treating COVID-19 infection. After the enrolment of approximately 30 subjects, the recruitment will be paused, and planned interim analysis will be performed to preliminarily investigate the efficacy and safety of TCMs in patients infected with COVID-19.

In December 2019, a cluster of patients with pneumonia in Wuhan, China, was caused by a novel betacoronavirus, which named the 2019 novel coronavirus (COVID-19). It was frequently reported that COVID-19 could be a public health crisis with high infectiousness, and it naturally spread across the country. Most of patients with COVID-19 infection were found to have non-specific symptoms including fever, cough, myalgia and fatigue. In addition, some patients were more likely to develop severe respiratory illness similar to severe acute respiratory syndrome (SARS), or even die. However, there was no timely and effective treatment of patients with COVID-19 infection. Traditional Chinese medicines (TCMs), are derived from plants and usually incorporate one or more herbs as the basic drug(s) to treat the disease. An RCT was performed to investigate TCM was effective and safe for treating COVID-19 infection. Eligible subjects will be randomized in a 1:1 ratio, and 1 subject on conventional medicines and TCMs granules for every 1 subject on conventional medicines. According to recommendations for prevention and control of pneumonia cause by COVID-19 infection from China National Health Commission, conventional medicines involve oxygen therapy and antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, p.o). Additionally, planned interim analysis will be performed, because the prevention and control of COVID-19 infection might affect estimated enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed COVID-19 infection case in term of laboratory evidence;
* 80 years ≥ age ≥ 14years;
* Within 72 hours after the onset of abnormalities shown by Chest radiology or several symptoms (fever and cough).

Exclusion Criteria:

* Age \< 14 years or \> 80 years;
* Pregnant or lactating female;
* One of the following items occurred at the enrollment: (i) respiratory failure necessitating mechanical ventilation; (ii) liver failure: total bilirubin ≥ 10mg/dL and/or severe coagulation disorders; (iii) renal function failure: although adequate circulating blood and cardiac output, urine ≤ 0.5ml/kg·h, Cr or BUN ≥ 1.5 times normal elevation;
* Intake of Chinese medicinal herbs during the past 2 weeks;
* Refused to sign an informed consent form prior to study participation;
* Unwilling and unable to comply with protocol request.
Pre-dinner vs. Post-dinner Exercise on Glycemic Control

With many medications we prescribe them relative to time of day or a meal. This study established if pre dinner vs post dinner exercise was more effective at altering post dinner glucose and triglyceride levels vs no exercise at all.

All participants completed three trials in a random order in which they consumed a standardized dinner meal with 1) no RE (NoRE), 2) pre-dinner RE (RE→M), and 3) post-dinner RE beginning 45 min after dinner (M→RE). Diet was standardized during the day of testing. Participants reported to the lab for testing sometime between 3 - 5:30 p.m. and upon arrival a venous catheter was inserted into a forearm vein. Frequent blood sampling, indirect calorimetry measurements, and subjective well-being measurements ensued for \~5.75 h while the participants were in the lab.

Eligibility Criteria:
Inclusion Criteria:

* Obese ( body mass index 30-45 kg/m2)
* Physician diagnosed with type 2 diabetes receiving standard medical care
* Non-smokers
* Pregnancy
* Lactating mothers

Exclusion Criteria:

* Insulin
* Surgical weight loss
* Orthopedic limitations to exercise
* Weight loss in the previous 3 months
Study Evaluating the Safety, Tolerability and Pharmacokinetics of NSA-789 in Healthy Japanese Male Subjects

This study will provide an initial assessment of the safety, tolerability and pharmacokinetics (PK) of NSA-789 after administration of ascending single oral doses to healthy Japanese male subjects. This is a randomized, double-blind, placebo-controlled, inpatient, sequential-group study conducted under fasting conditions at a single investigational site. Each subject will participate in only 1 dose group and will receive only 1 dose of test article.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 20 to 45 years inclusive at screening.
* Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion Criteria:

* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
* Use of any investigational drug within 90 days before study day 1 or prescription drug within 30 days before study day 1
* Any clinically important deviation from normal limits in physical examination, vital signs, 12-lead electrocardiograms (ECGs), or clinical laboratory test results.
Pain in Traumatic Brain Injury - Basile, MD

The observation through a chart review of persistent pain on neuro psychological functioning and how it applies to the community integration with patients that had suffered traumatic brain injury.

This pilot study is designed and conducted over a one year period by the PI, who then solely carried out this study from recruitment, to patient testing, to data entry. Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.

Eligibility Criteria:
Inclusion Criteria:

* documented history of traumatic brain injury
* 18 years or older

Exclusion Criteria:

* younger than 18 years old
* cannot read and write English
Effect of Bitter Melon Seed Oil on Body Weight

To investigate the metabolic benefits of bitter melon seed oil (BMSO), overweight or obese healthy Taiwanese adults (n=60) were randomly assigned to receive capsules containing either olive oil (OO; placebo) or BMSO at 4.5 g/d dose for 12 week. Across intervention period, body weight, BMI, waist-to-hip ratio, and body fat mass were measured. Blood were collected before and after intervention for measurements of blood lipid and inflammatory cytokines. The anti-obesity effect of BMSO was further assessed by stratification of participants according to UCP1 rs1800592 polymorphism.

Bitter melon is a common Asian vegetable. Its seed is not edible and discarded as a waste product. However, the seed oil is enriched in cis9, trans11, trans13-conjugated linolenic acid or alpha-eleostearic acid (alpha-ESA). Investigators previously demonstrated the anti-obesity functions of bitter melon seed oil (BMSO) in animal trials. Herein, a RCT was conducted to test the potential of BMSO in developing as a functional culinary oil for weight control.

Considering UCP-1 played a pivotal role in anti-adiposity function of BMSO as demonstrated in animal studies, the anti-obesity effect of BMSO was further assessed according to UCP1 rs1800592 polymorphism.

Healthy Taiwanese adults with overweight or obesity were recruited by advertisement and were assessed by a family medicine physician for eligibility. All participants signed the consent form. Blocked randomization was used to randomly assign participants into one of two groups to receive indicated supplement (BMSO or OO capsules with identical appearance; 4.5 g oil/d) for 12 week. Subjects were requested to maintain their usual diet and physical activity during the study period (0-12 week).

Anthropometric measurements were done on week 0, 4, 8 and 12. Three-day food records, collection of blood samples and physical health check were conducted on week 0, 4 and 12. Indirect calorimetry was done on week 0 and 12. Questionnaires about self-reported side effects, such as trouble sleeping, constipation, diarrhea, increased heartbeat, palpitations, headache, anxiety, or dizziness, were collected in each visit. Group allocation was concealed.

Eligibility Criteria:
Inclusion Criteria:

* adults with overweight or obesity (BMI ≥ 24 kg/m2 or waist circumference \> 90 cm in males and \> 80 cm in females)
* 20-64 y of age
* not currently using any weight-reducing agent

Exclusion Criteria:

* diabetes
* endocrine disease
* uncontrolled high blood pressure (systolic ≥ 180 mm Hg or diastolic ≥ 110 mm Hg)
* liver, kidney, or cardiovascular disease
* gastrointestinal disease
* psychological diseases
* pregnancy or lactation
* asthma and allergies
* smoking
* use of any drugs or dietary supplements that potentially affected body weight, blood lipids, blood pressure, or inflammatory responses.
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Chronic HCV infected males and non-pregnant/non-lactating females
* Treatment-naive or treatment-experienced individuals
* Non-cirrhosis or compensated cirrhosis at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.