cyrilzakka/clinical-trials huggingface dataset:
Study of Survival Duration for Donor Skin Cells in Skin Biopsy Wounds

The goal for this study is to examine the persistence of growth arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured using Y-STR for detection of Y-chromosome.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* Female, 18 years of age or older.
* Any race or skin type, provided that there are no tattoos within 5 cm of the wound target, and the gentian violet surgical marker produces a clearly visible mark on the skin.
* Willing to make all required study visits and, in the opinion of the Investigator, able to follow instructions.
* Willing to undergo the repeated biopsy procedures.
* Willing to undergo verification of sex chromosome status.

Exclusion Criteria:

* Males, or phenotypic females bearing Y-chromosome genetic material \[e.g., 46,X,(r)Y; 46,X,der(X)t(X;Y); sex reassignment surgery\].
* Contraindications or hypersensitivity to the use of the study medications or their components (e.g., history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B).
* History of keloid formation or hypertrophic scarring.
* Participation in any interventional clinical trial within 30 days prior to screening.
* History of prolonged bleeding, bleeding into joints, easy bruising following minor trauma, clotting factor deficiency, or current use of anticoagulants or platelet inhibitors.
* Any medical condition which, in the opinion of the Co-Investigator, may interfere with normal wound repair.
* Current therapy with drugs or biologics intended to function as immuno-suppressants, chronic (\> 10 days) oral corticosteroids, or any concomitant medication which, in the opinion of the Co-Investigator, may interfere with normal wound repair.
Novel Visual Education Tool to Improve Recognition and Reporting of Postpartum Urgent Maternal Warning Signs

This study aims to create a novel visual education tool that builds on the urgent maternal warning signs identified by The Council on Patient Safety in Women's Health Care. Including effective images will improve the understanding of these grave warning signs/symptoms, improving anatomical accuracy while remaining simplistic for patients of varying levels of health care literacy. The investigative team will be focusing on urgent warning signs pertinent to the postpartum period.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women
* Nulliparity
* Age \>18 years of age
* English speaking patients

Exclusion Criteria:

* Inability to provide informed written consent
* Refusal to participate in all study-related procedures
* Patients not fluent in English
* Patients with current or history of serious peripartum complications and/or events - such as DVT, PE, peripartum cardiomyopathy, etc. (in which the patient may have received more than standard clinical counseling)
* Patient with comorbidities that potentially require anticoagulation i.e. coagulopathies and may be more prone to DVTs
* Patients with uncorrected visual or hearing impairment
* Healthcare providers (in which patients will have significant background knowledge)
Comparison the Effects of Deep Water Running and Treadmill Running

The aim of this study is to compare the effectiveness of different exercise programs as 'Deep Water Running' and 'Treadmill Running' in sedentary young adults.

Rapid and explosive movements such as jumping or stair climbing need anaerobic performance. Anaerobic performance is negatively affected by sedentary behaviour due to loss of muscle strength and endurance. Exercise is an effective method to increase muscle strength and physical performance.

Exercising in water has unique physiological characteristics such as buoyancy, hydrostatic pressure, and metacentric effect. In addition, exercising in high speeds in water leads strengthening. Deep water running is employed to imitate the running on land. It is advocated that deep water running might result additional benefits than running on land. Therefore, the effect of the present study is to compare the effectiveness of deep water running and treadmill running in sedentary young adults.

Eligibility Criteria:
Inclusion Criteria:

* Being sedentary according to International Physical Activity Questionnaire
* Consent of the participant

Exclusion Criteria:

* Problems related to musculoskeletal, neurologic, and cardiopulmonary systems in last six months
* Any contraindication to exercise in water (water fear, allergy to chlorine)
* No willingness to continue in the study
Natural Helpers and PCIT

The purpose of the study is to evaluate the effect of a time-limited (i.e., 18 weeks) community health worker (CHW) intervention, referred to as the Parent Child Interaction Therapy (PCIT) plus natural helper (NH) model, on treatment engagement, retention, and child and caregiver outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Families of children 2 years of age to 12 years of age.
2. Children 2 to 7 years of age with a history of child abuse or neglect and/or child behavior problems or children ages 8 years to 12 years of age with history of or risk for abuse and the child does not exhibit clinically significant behavior problems.
3. At the time of enrollment, participants must agree that, within the upcoming six months, they will not move away to a location where they would no longer be able to regularly attend weekly sessions (i.e., moving out of Miami Dade County).

Exclusion Criteria:

1. Families with child younger than 2 years of age or older than 7 years of age with clinically significant behavior problems
2. Adults who are unable to consent and prisoners
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )

An autograft is a piece of skin taken from a healthy area of the body to be used to treat severe burns on another part of the same body.

StrataGraft skin tissue was an investigational tissue that could be used as an alternative to an autograft.

* StrataGraft skin tissue was in late-stage clinical development for the treatment of adults with deep partial-thickness (DPT) burns.
* There were no safety concerns reported to date. The sponsor submitted a treatment protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase 3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it was commercially available.

The main purpose of the study was to allow patients to receive StrataGraft during Biologics License Application review and prior to approval by the FDA for the treatment of DPT burns. The primary outcome measure was the number of participants with adverse events and safety concerns.

The primary purpose of this trial was to provide expanded access to StrataGraft for thermally induced DPT burns that contained intact dermal elements and for which surgical excision and autograft would normally be part of the clinical management.

Eligibility Criteria:
Inclusion Criteria:

To be considered for inclusion, a participant must:

* Provide written informed consent
* Have enough healthy skin to reserve as donor site(s), in case autografting becomes necessary
* Have protocol-defined thermal burn(s) on the torso, upper extremities and lower extremities:

  1. that are the right size for treatment areas,
  2. with intact dermal elements for which excision and autografting are clinically indicated, and
  3. have not been previously excised and grafted.

Exclusion Criteria:

A participant must be excluded from participation if he/she:

* Is pregnant, a prisoner, or expected to live less than 3 months
* Has any other condition that, per protocol or in the opinion of the investigator, may compromise the participant's safety or the study objectives
* Has participated in an investigational study within 90 days before enrollment
MRI in PROstate Cancer Diagnosis With Prior Risk Assessment

To evaluate the diagnostic performance and cost-effectiveness of the MRI-driven diagnostic pathway of prostate cancer, with upfront individual multivariate risk stratification.

Screening for prostate cancer (PCa) remains one of the most controversial issues in urological practice. Although robust data from the European Randomised study of Screening for Prostate Cancer (ERSPC) suggest a disease specific survival benefit in favor of prostate-specific antigen (PSA)-based PCa screening, the coinciding unfavorable harm-benefit precludes that PCa screening can be adopted as a public health policy. The diagnostic pathway needs to be optimized to reduce unnecessary testing and to avoid diagnosing those cancers that will never harm a patient if not detected through screening. Some men may thus benefit from PCa screening, but with the currently used diagnostics (i.e. the PSA test and systematic TRUS (transrectal ultrasound )-guided prostate biopsy) many more men are harmed by unnecessary testing and the cascade of diagnostic and treatment related events that follow.

Further refinements to screening strategies, focusing on detecting only those PCa that are potentially life threatening (clinically significant) are needed to become acceptable to the general population and health care providers. The investigators propose such a refinement within this protocol, with upfront individual risk prediction and in addition a MRI-driven diagnostic pathway in only those men that are considered to be at intermediate/high-risk of having a potentially life threatening PCa (in general defined as Gleason sum Score (GS) =7).

Eligibility Criteria:
Inclusion criteria:

* men ≥ 50 years,
* no prior prostate biopsies,
* suspected of having prostate cancer based on PSA blood test (≥ 3 ng/ml) and/or DRE( digital rectal examination) and/or family history of prostate cancer,
* fit to undergo all protocol procedures,
* signed informed consent.

Exclusion criteria:

* contra-indications to MRI or TRUS biopsy procedures,
* any medical condition precluding procedures described in the protocol
AMPLATZER Cardiac Plug Clinical Trial

The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Subject must have a documented history of paroxysmal, persistent or permanent nonvalvular atrial fibrillation
* Subject must be ≥18 years of age
* Subject must be on warfarin or dabigatran therapy
* Subject must be eligible for long term warfarin or dabigatran therapy
* Subject must have a CHADS(2) score of 2 or greater

Summary of Exclusion Criteria:

* Subject who requires warfarin or dabigatran for a condition other than AF
* Subject who is on clopidogrel or another P2Y12 platelet inhibitor such as prasugrel or ticagrelor
* Subject who has an absolute or relative contraindication to aspirin, or warfarin and dabigatran
* Subject with a New York Heart Association (NYHA) classification equal to IV
* Subject with an implanted or surgical repair atrial septal defect (ASD) device or patent foramen ovale (PFO) device
* Subject with aortic or mitral valve regurgitation of grade 2+ or greater
* Subject with left ventricular ejection fraction (LVEF) ≤30
* Subject with mitral or aortic prosthetic valve
* Subject with a history of hemorrhagic or aneurysmal stroke
* Subject with a history of previous radio frequency (RF) ablation for atrial fibrillation
* Subject with a body mass index (BMI) ≥40
* Subject with a history of acute or recent MI, or unstable angina, or coronary artery bypass graft surgery (within 6 months)
* Subject who is on aspirin dose therapy greater than 81mg/day at time of enrollment
Expanded Access Program (EAP): Allow Patients in the US With Idiopathic Pulmonary Fibrosis Access to Pirfenidone

This is an open label multi-center program to allow patients in the US with IPF access to treatment with pirfenidone.


Eligibility Criteria:
Inclusion Criteria:

* 1. Clinical and radiographic diagnosis of IPF including the presence of usual interstitial pneumonia (UIP) pattern or possible UIP pattern on historical HRCT (ATS 2011).

  2. %FVC ≥ 50% and %DLCO ≥ 30% based either on historical pulmonary function tests obtained in the 30 days prior to screening or on tests obtained during screening.

  3. Able to understand the importance of adherence to program treatment (pirfenidone) and protocol, and willing to follow all program requirements, including the concomitant medication restrictions, throughout the program.

  4. Able to understand and sign a written informed consent form.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the program:

1. Is receiving an investigational agent (defined as any drug that has not been approved for marketing for any indication in the US); prior use of pirfenidone is permitted.
2. Has received fluvoxamine therapy ≤ 28 days prior to the first dose of program treatment (pirfenidone) in PIPF-031, or is unable or unwilling to avoid fluvoxamine for the duration of the program.
3. Has any known contraindication for the use of pirfenidone, specifically:

   * Hypersensitivity to the active substance or to any of the drug product excipients
   * Severe hepatic impairment including end stage liver disease
   * Severe renal impairment (CrCl \< 30 mL/min) including end stage renal disease requiring dialysis
4. History of cigarette smoking within 3 months prior to the completion of screening or is unwilling to avoid tobacco products throughout program.
5. Known explanation for interstitial lung disease other than IPF, including but not limited to radiation, drug toxicity, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliterans organizing pneumonia, human immunodeficiency virus (HIV) infection, viral hepatitis, and cancer.
6. History of clinically significant environmental exposure known to cause pulmonary fibrosis (PF), including but not limited to drugs (such as amiodarone), asbestos, beryllium, radiation, and domestic birds.
7. Pregnancy or lactation. Women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of participation in the program. If abstinence is not practiced, one of the two methods of birth control should be a hormonal contraceptive (e.g., oral contraceptive and a spermicide).
Impact of Chronic Disease Control and Aging Psychology on Outcomes of Frailty-Sarcopenia Syndrome in Ambulatory Geriatric Patients

Pursuant to our previous longitudinal study (ClinicalTrials.gov ID: NCT02073370) in geriatric outpatients cooperated with the Department of Family Medicine, Department of Geriatrics and Gerontology, National Taiwan University Hospital, this study will be conducted to examine the impacts of the specific co-morbidities and ageing psychology on the outcomes of frailty/sarcopenia syndrome. The thresholds of specific chronic disease will be reviewed after frailty being considered in the elderly with co-morbidity condition. In addition, the conceptual framework and corresponding measuring instrument of "mental frailty" will be expected developed.


Eligibility Criteria:
Inclusion criteria : compatible one of following conditions

* functional decline in recent one year
* cognitive function decline
* depressive symptom
* mobility impairment
* fall in recent one year
* eating or feeding problems/weight loss
* co-morbid conditions≧5
* tracking by different physician ≧3 in recent half year
* polypharmacy≧8 in recent 3 months
* hospitalization ≧1 in recent one year
* emergency visits≧2 in recent one year
* aged ≧ 80

Exclusion criteria:

* non-ambulatory (bed-ridden) patients
* long-term residents at nursing homes
* patients with a life expectancy shorter than six months
* impairment in vision, hearing, or communicative ability
* making convenience of clinical evaluation during the study period impossible.
Research for Specific Proteins of Interest for the Serological Diagnosis of Bird Fancier's Lung

This study aims at identifying bird proteins useful for diagnostic tests to determine the cause of Bird Fancier's Lung (BFL).

Allergic diseases are an important part of health concerns in Europe and in countries "industrialized". Among them are distinguished from hypersensitivity pneumonitis (HP), consecutive to repeated inhalation of organic substances (bacteria, fungi, avian proteins ...).

As with other HP, the BFL is a invalidating disease, but usually not lethal if the patient reduced sufficiently early exposure to antigens.

Associated symptoms include breathing difficulties a dry cough, a general fatigued state accompanied by a fever and a rapid and pronounced weight loss.

These clinical signs may be similar to a flu-like condition, difficult to discern from other respiratory disease. Diagnosis is based on a set of clinical, radiological and biological arguments that are often discussed.

Using these criteria as predictors would increase opportunities to diagnose HP without using invasive clinical examinations such as biopsy and bronchoalveolar lavage.

Although serology is a useful argument for the diagnosis, its value is often criticized.

Thus, significant variations in performance of serological tests are observed from one provider to another and, for the same supplier, from one batch to another.

This issue could be raised by the use of recombinant antigens. The principle is to use only to the reaction the purified protein of interest produced by genetic engineering.

The Parasitology-Mycology department has acquired expertise in the research of proteins of interest for serology allergic diseases and in the manufacture of recombinant antigens. Thus the work of the team have identified proteins of interest for the diagnosis of two HP of occupational origin and translates this expertise to identify pigeon's proteins and study the feasibility of this research.

For this project, the pigeon droppings (Columba livia), collected from different breeders in the region were identified as antigenic source.

The objective of the HYPERSENS project is to extend the problematic to other species of birds and understand the specific species of antigenic proteins. The aim is also to identify and produce recombinant proteins that will identify the cause of avian hypersensitivity pneumonitis.

Eligibility Criteria:
Inclusion criteria:

* Exposure known about birds
* Non-smoker
* Absence of compatible respiratory symptoms with a HP

Exclusion Criteria:

* Farmer,
* smoker,
* pregnancy and feeding,
* minor subject,
* known immunizing deficit
Characteristics of Glargine in Type 2 Diabetics

The study is to determine the dose response relationship of insulin glargine in type 2 diabetes over a 24-hour period and measuring the differences in glucose production among the differing doses of glargine.

Hypothesis: Differing doses of insulin glargine over a 24-hour period in type 2 diabetes will show differing effects on endogenous glucose production, glucose disposal and carbohydrate and lipid flux.

The incidence of type 2 DM is increasing worldwide at an alarming rate. Unfortunately, the number of individuals with glycemic control at or below the American Diabetes Association goal of 7% has dropped. In fact, the number of patients with their important cardiometabolic risk factors of glucose, lipids and blood pressure at goal is only 7%. One of the reasons for this lack of metabolic control in type 2 DM is the continued relative underutilization of insulin. Diabetes is an insulin deficient state and requires appropriate physiologic replacement of insulin. Physiologic replacement of insulin requires a basal component to restrain overnight endogenous glucose production, lipolysis and proteolysis. The other component involves prandial insulin to regulate post prandial glucose levels. Recently, insulin glargine was introduced as a once-a-day peakless basal insulin. This form of basal insulin reproduces the normal constitutive physiologic release of insulin from the pancreas. Insulin glargine represents a breakthrough in treatment as the previous available "basal insulins" either produced peaks of activity (which are disadvantageous as this results in hypoglycemia) or do not last 24 hrs which results in post absorbative hyperglycemia. Despite the undoubted advantages of insulin glargine, there remains a lack of information regarding some aspects of glargine action. The study objectives are: 1) to determine the pharmacokinetic and pharmacodynamic dose response relationship of insulin glargine in Type 2 DM; 2) partition the dose response relationship of insulin glargine on endogenous glucose production and glucose uptake in Type 2 DM; and 3) to determine if the pharmacokinetic and pharmacodynamics of insulin glargine are consistent over a wide range of doses.

Eligibility Criteria:
Inclusion Criteria:

* 12 adults (males or females) with type 2 diabetes for at least six (6) months. May be using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin.
* HgbA1c 7 -12%
* Age 18-70 years
* BMI 27-40 kg/m²

Exclusion Criteria:

* Any past or present clinically relevant abnormality, medical condition, or circumstance making the subject unsuitable for participation in the study
* Evidence of hepatic, renal or cardiac failure
* Abnormal results following screening tests
* Pregnant or lactating females or females of childbearing potential who are unwilling to abstain from sexual intercourse or use reliable, medically accepted methods of contraception
* Currently using TZDs
* History of alcoholism or drug abuse within 12 months of the study