cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
* Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
* Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
* Regular or steady menstrual cycle lasting from 24 to 36 days
* Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
* Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug

Exclusion Criteria:

* Documented endometriosis or active pelvic inflammatory disease
* History of alcohol and/or drug abuse
* Any history or diagnosis of gynecological cancer or cervical dysplasia
* Use of an IUD
* Use of prohibited concomitant medications:

  * Use of Depo-Provera must cease 10 months prior to first dose of study drug
  * Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
* Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
Vascular Regenerative Cell Exhaustion in Adults with Peripheral Artery Disease (PAD-VRCE)

PAD-VRCE is an observational, cross-sectional, two arm study aimed at determining if the presence of peripheral artery disease (PAD) can influence the number of circulating regenerative cells in blood. From peripheral blood samples, circulating progenitor cell content will be assessed via flow cytometry and compared between individuals with PAD and individuals without PAD. Ultimately, this study plans to evaluate the relationship between PAD, vascular regenerative cell exhaustion and overall cardiovascular health.

Individuals with peripheral artery disease (PAD) have been shown to have poorer cardiovascular health outcomes than the general population. It is believed that the number of people living with PAD is greatly underestimated and furthermore, mortality due to the most severe form of PAD - critical limb ischemia - is increasing. There is a growing body of evidence that the presence of cardiovascular risk factors leads to the imbalance of circulating regenerative cells. The aggregate impact of this regenerative cell exhaustion phenotype is an increased risk of adverse events and progression of disease states.

PAD-VRCE is an observational, cross-sectional, two-arm cohort study aimed at determining the differences in the progenitor cell profiles in the blood of individuals with PAD in comparison to individuals without PAD. We hypothesize that people with PAD will exhibit depleted levels of these progenitor cells defined as vascular regenerative cell exhaustion. VRCE impacts the function of anti-inflammatory cells and associated repair mechanisms within blood vessels, and may contribute to the differential long term outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Adults ≥18 and ≤80 years of age who meet either of the following criteria:

   1. Clinically significant/symptomatic PAD (defined as symptomatic claudication with and an ankle brachial index of less than 0.85).
   2. No history of PAD.
2. Willing and able to provide written informed consent and comply with study procedures.

Exclusion Criteria:

1. Unable or unwilling to provide written informed consent or to provide a peripheral blood sample.
2. Any life-threatening disease expected to result in death within two years.
3. Any malignancy not considered cured (except basal cell carcinoma of the skin). An individual is considered cured if there has been no evidence of cancer recurrence for the five years prior to screening.
4. Uncontrolled hypertension.
5. New York Heart Association Class IV heart failure.
6. Active liver disease or liver dysfunction.
7. Active kidney disease or kidney dysfunction.
8. History of hemorrhagic stroke or other major bleeding disorder.
9. White blood cell count of ≥15x10\^9/L.
10. Active infectious disease requiring systemic antibiotic or anti-viral agents.
11. Known acquired immunodeficiency syndrome, such as Human Immunodeficiency Virus.
12. On oral steroid therapy (e.g. prednisone or other corticosteroids) or other immunosuppressive agents (e.g. methotrexate).
13. Treated autoimmune disorders
VALIDATE: Virtual Agent Linked Intelligent Disease Assessment Tool Engine

The collection and analysis of family, medical, lifestyle, and environmental exposure history (a Comprehensive Health History or "CHH") can identify critical risk factors for many chronic and life-threatening conditions, including cancer. Despite its importance, CHH is infrequently documented and analyzed in primary-care medical practice due to numerous hurdles, and currently available tools have proven inadequate to address this critical problem. This study will evaluate the Virtual Agent Linked Intelligent Disease Assessment Tool Engine ("VALIDATE") system as an easy to administer, accurate, cost-effective, and clinically useful tool for collecting and analyzing structured CHH data.

Our study's objective is to evaluate the Virtual Agent Linked Intelligent Disease Assessment Tool Engine ("VALIDATE") system as a means to improve the affordability and ease, while maintaining the validity and feasibility, of collecting, assessing, and acting on Comprehensive Health History data.

Virtual Agents (VAs) are fully autonomous and embodied software agents that use both verbal (e.g. speech) and non-verbal modalities (e.g., gaze, gesturing) to simulate a clinician-patient encounter. These agents have already successfully shown advantages to patients for: entering family history data on their own, facilitating medication adherence, providing behavioral health information, serving as clinical interviewers, promoting breastfeeding, and educating about and motivating exercise and weight loss. The VALIDATE system has been developed to be a fully automated alternative to the currently extremely labor-intensive process of collecting and transcribing CHH data. VALIDATE will be evaluated for its capability to significantly diminish clinician time and cost to collect, review, analyze, and document accurate and complete certain CHH data directly from patients at home using their own personal desktop computers. VALIDATE will also be evaluated for its capability to identify valid clinical action, e.g. referral indications for familial cancer assessment based on American College of Medical Genetics and Genomics (ACMG)/National Society of Genetic Counselors (NSGC) and National Comprehensive Care Network (NCCN) Guidelines.

Eligibility Criteria:
Inclusion Criteria:

All adults above the age of 18

Exclusion Criteria:

Children under the age of 18
Efficacy of autoPPC for the Treatment of Obstructive Sleep Apnea Syndrome (OSAS)

Obstructive Sleep Apnea Syndrome (OSAS) is a common condition that leads to daytime sleepiness and loss of vigilance and, in addition, increased risk of cardiovascular events. The most effective treatment consists in ventilation by mask with continuous positive airway pressure (CPAP), that prevents collapse of the upper airway. However the degree of collapsibility of the pharynx may vary in relation to position, sleep stage, or alcohol or sedative consumption. Thus, CPAP treatment (invented in 1981) has evolved with the development of more sophisticated equipment that permits adapted variations in pressure levels (autoCPAP) with the objective adjusted pressure to avoid airways obstruction with minimal pressure.

Different models of autoCPAP function with different signals and event detection algorithms with different modes of reaction to events. These machines are marketed with CE certification, that guarantees electrical security, but there is to date, no requirement for pre-marketing clinical validation. Nonetheless inadequate treatment may leave patients at risk of accidents and cardiovascular events. These machines can be bench tested using test equipment that can measure with accuracy the response to simulated events, but the testing equipment cannot simulate the diversity of clinical situations, nor the residual level of microarousals that may persist. Thus these bench tests need to be supplemented by clinical studies. The investigators objective is to test the efficacy of these machines on residual sleep-related events during a one night autotitration polysomnography. We develop a prospective, multicentre, non randomised study with autotitration polysomnography only for one night. These clinical results will be compared with the results of bench tests in order to evaluate the pertinence of the bench tests and their eventual utility to simplify clinical evaluation. The perspective of developing a reliable testing protocol may eventually play a role in the certification of these machines.


Eligibility Criteria:
Inclusion Criteria:

* Patients with obstructive sleep apnea syndrome and indication for autoPPC

Exclusion Criteria:

* Patients with COPD, or evolutive heart disease Patients with evolutive cancer Patients already with PPC machine Patients simultaneously included in another clinical study.
Effect of Metabolaid® on AMPK Activation for Weight Loss

The objective of this study was to establish a formulation, containing both Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) extracts (Metabolaid®) that had significant capacity to activate the AMPK-enzyme and to reduce triglyceride accumulation in the hypertrophied adipocyte model. Then, we assessed the efficacy of this combination in light-to-moderate-overweight subjects under risk of developing metabolic syndrome.

AMP-activated protein kinase (AMPK) has been postulated as a molecular target in the amelioration of obesity-related diseases, where most therapeutic approaches have failed. Plant-polyphenols have shown the capacity to ameliorate obesity-induced metabolic disturbances. A combination of polyphenols (LC-HS) derived from Hibiscus sabdariffa L. (HS) and Lippia citriodora L. (LC) (lemon verbena) (Metabolaid®) was assessed for triglyceride accumulation and AMPK activation in the hypertrophied adipocyte model 3T3-L1. A dietary supplement containing 500 mg of LC-HS was evaluated in a double blind, placebo-controlled and randomized trial in 56 overweight subjects for two months. Anthropometric and circulating biochemical parameters were determined.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a body mass index (BMI) from 24 to 34 kg/m2

Exclusion Criteria:

* total cholesterol lower than 200 mg/dL.
* use of prescription medication for cholesterol or hypertension.
* presence of any obesity-related pathology.
* hormone replacement therapy.
* consumption of antioxidant supplements/drugs.
* alcohol addiction.
* women who were pregnant or lactating.
Cardiovascular Risk Stratification in Covid-19

This retrospective double-cohort study seeks to:

1. Describe the cardiovascular manifestations and electrophysiological (EP) substrate in COVID-19 infection and their association with clinical outcomes; and
2. Develop a method of cardiovascular risk stratification in COVID-19


Eligibility Criteria:
Inclusion Criteria:

* age \>=18y
* available data on Covid19 test in the electronic medical record (either positive or negative)

Exclusion Criteria:

* no data of Covid19 test
Expanded Access Program Using Uromune for Patients With Recurrent Urinary Tract Infections (rUTI)

An Expanded Access Program for UROMUNE® for patients suffering from recurrent/chronic urinary tract infections of diverse etiology. This is for individuals for whom antibiotic therapy has failed, but of consideration in all cases, taking into account antibiotic-induced adverse reactions and increasing antibiotic resistance.

UROMUNE® is a mucosal immunotherapy indicated for the prevention of urinary tract infections caused by different pathogens. It works by stimulating the immune system, thus increasing the resistance against recurrent infections. The active substances are 4 inactivated and selected bacterial strains:

* Klebsiella pneumoniae 25%
* Escherichia coli 25%
* Enterococcus faecalis 25%
* Proteus vulgaris 25%

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering recurrent urinary tract infections of diverse etiology.

Exclusion Criteria:

* Individuals being allergic to any of the ingredients of UROMUNE®.
* Pregnancy and breast feeding. There are neither specific studies nor a formal contraindication, the physician should value benefits/risk.
Endoscopic Submucosal Dissection Combine With Laparoscopic Regional Lymph Node Dissection for Early Gastric Cancer

The purpose of this study is to determine whether Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection for early gastric cancer can improve Disease-free survival ？

Patients with early stage of gastric cancer(T1a/T1bN0M0,NCCN2014.V1) will depart into two group randomized double-blind, then experimental group accept Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection ,and control group accept Endoscopic Submucosal Dissection only.The follow-up time is from operation to recrudescence.

Eligibility Criteria:
Inclusion Criteria:

* cT1a：ulcer（+）and lesion diameter\>3cm and differentiated type. Any ulcer and lesion diameter d\>2cm and poorly differentiated type.
* cT1b: Submucosal injection (+)

Exclusion Criteria:

* metastasis
* recrudescence
Nutritional Supplementation of Flavonoids Quercetin and Curcumin for Early Mild Symptoms of COVID-19

The purpose of this study is to investigate the therapeutic benefits of flavonoids nutritional supplements quercetin and curcumin for early mild symptoms of COVID-19.

Flavonoids nutritional supplements quercetin and curcumin have demonstrated strong antioxidant, broad-spectrum anti-viral and anti-inflammatory properties including against the respiratory tract infections. They are widely used to boost the immunity against infections and keeping healthy life-style. Results from recent published studies have shown positive results for quercetin and curcumin in patients with COVID-19.

In the present study the investigators aim to study the combined beneficial effects of quercetin and curcumin in addition to standard of care for managing early mild symptoms of COVID-19 in community-based patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be 18 years of age or older, of either gender
* Patients must be tested positive for SARS-CoV-2 by RT-PCR
* Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever, fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain etc.
* Patients must be in the early stage of COVID-19 disease who do not require hospitalization at the time of screening
* Patients must be under the care of a Physician for diagnosis of COVID-19
* Patients who have signed informed consent

Exclusion Criteria:

* Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
* Patients with known chronic kidney disease with estimated creatinine clearance \< 50 mL/minute or need for dialysis
* Patients who are severely hypotensive defined as needing hemodynamic pressors to maintain blood pressure
* Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin, Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
* Patients with gallstone obstruction
* Hypothyroid suppering patients
* Patients with moderate or severe thrombocytopenia (platelet count \<100 ×10⁹/L);
* Pregnant patients
Chlorhexidine and Essential Oil Mouthwashes on Human Beta-Defensin 2 (hbD2) and Kathelicidin (LL-37) Saliva Levels

Recent studies have shown that while mouthwashes exhibit antimicrobial properties against bacteria and their products, at the same time showing the cytotoxic effect on living cells in the mouth.29 To the best of our knowledge, there is no information about the toxicity effect of these two mouthwashes, which are highly preferred, on antimicrobial peptides secreted from the oral epithelium. Therefore, our aim in this study is to evaluate the effect of chlorhexidine and essential oil mouthwash on hBD2 and LL-37 in saliva.

Periodontal health continues with a balanced interaction of the oral microflora with the host defense line.

Eligibility Criteria:
Inclusion Criteria:

1. systemically healthy,
2. presence of ≥20 natural teeth,
3. agreement to participate in the study .

Exclusion Criteria:

1. known systemic illness,
2. smoking habit,
3. pregnancy/ lactation,
4. long-term use of anti-inflammatory drugs.
A Phase 1 Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Ipilimumab in Chinese Subjects With Select Advanced Solid Tumors

The purpose of this study is to determine whether ipilimumab is effective in the treatment of select advanced (unresectable, metastatic, or recurrent) solid tumors in Chinese subjects.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Subjects with the following advanced solid tumors; metastatic or recurrent
* Must have measurable/non-measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria.
* Subjects have ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up
* Chinese women and men, ages 18 years or older

Exclusion Criteria:

* Subjects with brain metastases are excluded unless clinically stable for more than 4 weeks at the time of randomization as determined by the investigator
* Subjects with ocular melanoma are excluded
* Any other malignancy from which the subject has been free of disease for less than two years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
* History of, or currently active, autoimmune diseases, including but not limited to inflammatory bowel disease, rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies (eg, Guillain-Barre syndrome). Vitiligo is not excluded
* Any current or history of immunodeficiency, splenectomy, or splenic radiation

Other protocol defined inclusion/exclusion criteria could apply
Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

This study evaluates the effects of roflumilast on restoring response β2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo.

T2 low asthma is common in obese asthmatics. New evidence suggests that hyperinsulinemia and insulin resistance, both common in obesity, are associated with an increased risk of concurrent asthma.

Targeting Phosphodiesterase 4 inhibitors (PDE4) allows for examination of a mechanism potentially linking obesity and asthma as well as identification of readily available and safe options to treat hyperinsulinemic, overweight asthmatics.

It is hypothesized that obesity and hyperinsulinemia contribute to asthma by impairing β2 adrenoreceptor function and that this can be rescued the PDE4 inhibitor, roflumilast.

Eligibility Criteria:
Inclusion Criteria:

* Have a physician diagnosis of asthma.
* Require treatment with moderate to high-dose \>2500mcg/day of fluticasone or equivalent, or use of oral steroids

Also two of the following:

* Requirement for additional daily treatment with other controller medication
* Daily Asthma symptoms
* Forced Expiratory Volume / Forced Vital Capacity (FEV1/FVC) \< 70% and FEV1\< 80% predicted
* ≥1 urgent care visits/year
* ≥3 oral steroid bursts/year
* Near-fatal asthma event.
* Exhaled Nitric oxide (FeNO)\<30 ppb
* Peripheral blood eosinophil count \< 300 (x10-6/ul)
* Obesity, BMI≥30

Exclusion Criteria:

* Less than 18 years of age
* baseline FEV1 \<30% predicted
* pregnant or nursing women
* current smokers or subject with \>20 pack year history
* any history of intolerance of, or reaction to, Roflumilast.
* Prisoners
* Patients with liver disease
* Subjects with Hepatic impairment (contraindicated in moderate-to-severe liver impairment: Child-Pugh Score Class B/C) for example.
* Patients with clinically significant psychiatric history (i.e., suicidality, etc.) and psychiatric illness
* Patients using strong CYP 450 enzyme inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin).
The Effect of Neoadjuvant Chemotherapy on Locally Advanced Gastric Cancer

The aim of this study is to evaluate survival benefit of a neoadjuvant chemotherapy regimen in patient with resectable locally advanced gastric cancer in comparison with surgery alone.

Adenocarcinoma of the stomach ranks as the fourth most commonly diagnosed cancer and as the second leading cause of cancer-related death in the world. Radical resection with free-margin gastrectomy and extended lymphadenectomy is the preferred surgical strategy in Japan and Asian centers.

Unfortunately, only one-half of surgically treated patients with gastric cancer will achieve a complete resection without residual disease (R0) resection. Moreover, due to, the absence of routine screening programs for gastric cancer, the majority of the patients will be symptomatic at the time of diagnosis in our country.

Additionally, recent treatment strategies were focused for downsizing or decreasing to loco-regional recurrence.

In this reason, we hypothesize that preoperative chemotherapy may improve the R0 resection rate or disease free and/or overall survival rate.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven adenocarcinoma of stomach
* T3 or T4
* N1 or N2
* M0
* No evidence of para-aortic or retropancreatic lymph node metastasis, peritoneal dissemination or Krukenberg tumor.
* No involvement of the esophagus with \> 2cm
* An age of 18-90 years
* A Karnofsky Performance status with 60-100% or Eastern Cooperative Oncology Group (ECOG) performance status (0-2)
* No previous chemotherapy, radiotherapy for any malignancy.
* No previous surgery for gastric cancer
* No evidence obstructive or bleeding symptoms.
* Adequate renal and hepatic function
* Written informed consent

Exclusion Criteria:

* Synchronous or metachronous malignancy diagnosing within 5 year
* Pregnancy or lactation in female patients
* Any immunosuppressive condition (acquired or iatrogenic)
* Any infectious toxic or mental condition preventing neoadjuvant therapy