cyrilzakka/clinical-trials huggingface dataset:
Patient and Physician Survey Determinants of Appropriate ICD Utilization

To better understand the reasons for underutilization of defibrillator therapy in selected populations, the investigators propose a study to assess heart failure patient knowledge and attitudes toward device therapy. By carefully studying populations of patients with systolic heart failure, the investigators aim to identify the underlying reasons for implantable cardioverter defibrillators (ICD) non-utilization in patients with symptomatic systolic heart failure.

Several multi-center randomized trials have demonstrated the benefit of implantable cardioverter defibrillators (ICDs) for the primary prevention of sudden cardiac death among patients with ischemic and nonischemic cardiomyopathy. Guideline documents for the treatment of heart failure have recommended defibrillator placement for patients with symptomatic heart failure and left ventricular ejection fraction (LVEF) ≤ 35%. Despite these recommendations, observational studies have documented low ICD utilization among patients with heart failure. Recent studies have demonstrated patient specific characteristics that are associated with low ICD utilization (advanced age, female gender, black race, heart failure etiology, uninsured patients and patients cared for by general practitioners). Whether patient knowledge or attitudes regarding defibrillator therapy influence the rate of defibrillator placement is unknown. By carefully surveying populations of patients with systolic heart failure, we aim to further the understanding of the patient factors that determine why an ICD may or may not be used in the appropriate clinical setting. Additionally, 150 physicians will be enrolled into the study for the purpose of measuring attitudes and beliefs regarding defibrillator treatment for the physicians providing care to the patients in the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Left ventricular ejection fraction ≤ 35%
* Previous diagnosis of heart failure with current NYHA Class II-III symptoms
* Established UMHS patient with at least two outpatient visits in the past two years to either Primary Care or Cardiology, OR, at least one inpatient admission in the past two years along with at least one outpatient visit within the past 13 months to Primary Care or Cardiology

Exclusion Criteria:

* Patients having undergone heart transplantation
* Patients having undergone placement of a left ventricular assist device
* Patients with congenital heart disease
Validation of a Nutrition Screening Tool

The purpose of this study is to compare the accuracy of a new consumer nutrition screening tool to an established and validated nutrition screening tool currently completed by healthcare practitioners.

The main objective of the study is to determine the accuracy of the self-administered consumer Mini Nutritional Assessment by comparing the level of agreement in the categorization of nutritional status between the self-administered Mini Nutritional Assessment and a validated nutrition screening tool in a population aged 65 and older.

Eligibility Criteria:
Inclusion Criteria:

- Consumer

* Age ≥ 65 years
* Employed part-time, unemployed, retired, full-time homemaker
* English speaking

  - Caregiver of Consumer
* Family, relative, friend, professional caregiver of an individual age ≥ 65 years
* Lives with individual aged ≥ 65 years OR Visits individual aged ≥ 65 years five or more days a week

  * Makes decisions or has strong influence on the individual aged ≥ 65 years' diet and medical needs.
* English speaking

Exclusion Criteria:

- Consumer

-- Full time employment
PACMAN - PAcing for CardioMyopathies, a EuropeAN Study

The purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an ICD indication

Heart Failure is a syndrome that affects millions of patients in Europe with over half a million new cases reported annually. Drug therapy had been the conventional treatment of choice until the emergence of cardiac resynchronization therapy (CRT) where biventricular pacing can be delivered to the heart through a pacemaker or implantable cardioverter defibrillator. This study was designed to assess the effect of CRT on patients optimized on conventional heart failure medication including diuretics, beta blockers and ACE inhibitors. The effect of CRT was evaluated by comparison of 6 minute walk performance, Quality of Life and NHYA class after 6 months with CRT therapy either programmed ON or OFF. In addition, evaluation of the incidence of adverse events (predefined as ventricular arrhythmias, hospitalizations, drop-outs, complications and patient deaths) was done between groups at 6 months. Patients were all programmed ON after 6 months and data was collected for an additional 6 months.

Eligibility Criteria:
Inclusion Criteria:

- NYHA Class III and IV with EF \< 35%; Optimal individual drug therapy in 2 weeks prior to enrollment including ACE inhibitors; beta blockers and diuretics unless not tolerated

Exclusion Criteria:

* Reduced life expectancy of \< 6 months or candidate for heart transplant within 6 months; chronic/recurrent atrial fibrillation/flutter
MRI in Ductal Carcinoma in Situ (DCIS)

Compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 ans
* Woman with DCIS

Exclusion Criteria:

* Age ≥18 ans)
A Study to Evaluate the Durability of Response of CTP-543 in Adult Patients With Moderate to Severe Alopecia Areata

This study is designed to evaluate the regrowth of hair with CTP-543 and subsequent durability of that regrowth following dose reduction in adult patients with moderate to severe alopecia areata.


Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of alopecia areata with a current episode of scalp hair loss lasting at least 6 months and not exceeding 10 years at the time of Screening. Total disease duration greater than 10 years is permitted.
* At least 50% scalp hair loss, as defined by a severity of alopecia tool (SALT) score ≥50, at Screening and Baseline.
* Willing to comply with the study visits and requirements of the study protocol.

Exclusion Criteria:

* Treatment with other medications or agents within 1 month of Baseline or during the study that may affect hair regrowth or immune response.
* Active scalp inflammation, psoriasis, or seborrheic dermatitis requiring topical treatment to the scalp, significant trauma to the scalp, or other scalp condition that may interfere with the SALT assessment, or untreated actinic keratosis anywhere on the body at Screening and/or Baseline.
* Treatment with systemic immunosuppressive medications within 3 months of Screening or during the study, or biologics within 6 months of Screening or during the study.
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug.
* Clinically significant medical condition, psychiatric disease, or social condition, as determined by the Investigator, that may unfavorably alter the risk-benefit of study participation, adversely affect study compliance, or confound interpretation of study results.
Study on Mhealth and Reproductive Health in Teens

The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate the effectiveness of using text messages to improve the knowledge, communication, and attitudes about reproductive health among female adolescents in Greater Accra senior high schools. Previous research as well as qualitative work conducted by the Investigators shows that there are significant gaps in knowledge about reproductive health including on topics of pregnancy, sexually transmitted diseases, and contraception among secondary school students in Greater Accra. These gaps contribute to unwanted pregnancy and spread of sexually transmitted diseases. At the same time, phone ownership and use among young people has spread rapidly, especially in urban areas such as Accra. The Study on Mhealth and Reproductive Health (SMART) will seek to use mobile phone messages to increase awareness of these reproductive health issues among female adolescents in Accra. The objectives of SMART are to evaluate whether the messages can increase knowledge, increase communication, and improve attitudes towards reproductive health among adolescents in Greater Accra. By conducting a randomized controlled trial, we will be able to statistically evaluate if the messages have had any effect on improving outcomes for adolescents in the areas of knowledge, communication, and attitudes. This work can help guide future programs that can scale up this intervention and ultimately improve the health and wellbeing of adolescents across Ghana.


Eligibility Criteria:
Inclusion Criteria (for treated and control subjects):

* female
* aged 14-24
* secondary school student at day school

Exclusion Criteria (for treated and control subjects):

* male
* secondary school student at boarding school

Inclusion criteria (for spillover subjects):

* aged 14-24
* secondary school student at day school

Exclusion Criteria (for spillover subjects):

- secondary school student at boarding school
A Study of LY2523355 in Participants With Breast Cancer

The purpose of the study is to evaluate the anti-tumor activity of LY2523355 relative to ixabepilone for the treatment of metastatic or locally recurrent breast cancer using change in tumor size as a continuous measure of response.


Eligibility Criteria:
Inclusion Criteria:

* Have histologic or cytologic diagnosis of metastatic or locally recurrent breast cancer that is not amenable to therapy given with curative intent.
* Have measurable disease defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 guidelines.
* Have received 2 or more prior standard cytotoxic chemotherapy regimens for metastatic breast cancer and be, in the opinion of the investigator, an appropriate candidate for experimental therapy. Regimens received in the neoadjuvant or adjuvant setting are not counted as prior regimens.
* Have received a prior taxane in the neoadjuvant, adjuvant, or metastatic setting.
* Have recovered from the acute effects of prior chemotherapy, hormonal therapy, and radiation prior to study enrollment.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale.
* Have adequate organ function.

Exclusion Criteria:

* Have Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater (moderate or worse) peripheral neuropathy
* Have a second primary malignancy.
* Have symptomatic, untreated, or uncontrolled central nervous system metastases.
* Have received autologous stem cell transplant following high-dose chemotherapy.
* Have serious preexisting medical conditions that in the opinion of the investigator would preclude participation in this study.
* Have active symptomatic fungal, bacterial, and/or known viral infection including active human immunodeficiency virus (HIV) or viral hepatitis.
* Have previously received LY2523355 in another study investigating this agent or therapy with ixabepilone or an ixabepilone-containing regimen.
* Have a history of radiation therapy involving more than 25 percent of the bone marrow.
* Have a Fridericia corrected QT (QTcF) interval of \>470 milliseconds (msec) on screening electrocardiogram (ECG).
* Have QRS widening of \>120 msec on screening ECG.
* Cannot change or stop taking a strong Cytochrome P450 3A4 (CYP3A4) inhibitor or CYP3A4 inducer per the ixabepilone label.
* Have hypersensitivity to drugs formulated with Cremophor® EL per the ixabepilone label.
Measuring the Glycemic Index and Tracking Metabolites of New and Emerging Lentil Varieties

It is not known whether different lentil varieties have the same efficacy in lowering blood glucose. Similarly, the carbohydrate component of lentils responsible for lowering blood glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol bioactive.

The overall aim of this work is to produce credible evidence for substantiating a food health claim for post prandial blood glucose lowering by lentil. Although several studies have shown that lentil consumption results in a lowering of post prandial blood glucose, it is not known whether different lentil varieties have the same efficacy. Similarly, the carbohydrate component of lentils responsible for lowering blood glucose is not known, nor is the bioavailability of lentil metabolites and polyphenol bioactive. The investigators hypothesize that the slowly digestible starch content of lentil is inversely related to in vivo glycemic response. The specific aims of this study are: (i) to identify the putative component(s) in lentil that might account for its blood glucose lowering effect, and (ii) to identify differences in blood glucose reduction among lentil varieties. These aims will be achieved in a three-step process. Firstly, in vitro studies will be pursued to determine the carbohydrate fractions of 20 new and emerging Canadian lentil varieties. Secondly, these results will be used to choose 8 lentil varieties with different slowly digestible starch content for a human Glycemic Index study. Thirdly, identification of lentil metabolites will be achieved by collecting extra capillary blood (200uL)and urine samples at fasting and 120min for measurement of polyphenols and metabolites using established HPLC and metabolomics techniques.

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant females, 18-75 years of age, inclusive
* Body mass index (BMI) \< 40 kg/m²
* Willing to maintain habitual diet, physical activity pattern, and body weight throughout the trial and to refrain from smoking for 12hr prior to each visit.
* Normal fasting serum glucose (\<7.0mmol/L capillary corresponding to whole blood glucose \<6.3mmol/L).
* Understanding the study procedures and willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study investigator.

Exclusion Criteria:

* Failure to meet any one of the inclusion criteria
* Known history of AIDS, hepatitis, diabetes or a heart condition
* Subjects using medications or with any condition which might, in the opinion of Dr. Wolever, the Medical Director of GI Labs, either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
* Major trauma or surgical event within 3 months of screening.
* Unwillingness or inability to comply with the experimental procedures and to follow GI Labs safety guidelines.
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
HIV Prevention Preparedness Study

The purpose of this study is to provide researchers with information that will help them prepare for a future study to test the efficacy of two anti-HIV vaginal gels. This study will also estimate how likely people living in certain areas are to become infected with HIV and other infections passed during sex.

This study is designed to prepare for the implementation of a second study, HPTN 035: A Phase II/III Safety and Effectiveness Study of the Vaginal Microbicides BufferGel and PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women. HPTN 035 requires an average HIV seroincidence rate of 5-6 percent among enrolled participants. The primary objective of the present study is to estimate the rates of HIV seroincidence among women targeted for inclusion in HPTN 035.

Women will be enrolled in this study for 6 to 12 months. Study visits will take place monthly. At each visit, participants will complete a medical/menstrual history and undergo pregnancy testing. Each quarter, participants will undergo a structured interview about sexual practices and will receive HIV and STD tests, education, and counseling. Participants will also undergo a pelvic exam with wet mount testing for bacterial vaginosis, candidiasis, and trichomoniasis. Colposcopic evaluations will be performed at selected sites. Pap smears will be performed at sites with the capacity and expertise to prepare and interpret the smears and provide appropriate follow-up care to participants with abnormal results.

Eligibility Criteria:
Inclusion criteria:

* Sexually active (defined as having had vaginal intercourse at least once in the 3 months prior to screening).
* HIV-uninfected at screening.
* Able and willing to provide adequate locator information for study retention purposes.

Exclusion criteria:

* History of adverse reaction to latex.
* Non-therapeutic injection drug use in the 12 months prior to screening.
* Vaginal intercourse more than an average of 2 times per day in the 2 weeks prior to screening.
* Plans to travel away from the study site for more than 3 consecutive months in the next 12 months.
* Plans to relocate away from the study site in the next 12 months.
* Pregnancy or plans to become pregnant in the next 12 months.
* Pregnancy within 42 days prior to enrollment.
* Enrollment in any other study of a vaginally-applied product.
* Clinically apparent pelvic exam finding involving deep epithelial disruption.
* Diagnosis with a current STD and/or other reproductive tract infection requiring treatment.
* Conditions that would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
A Pharmacokinetic Study to Evaluate BBI-5000 Capsules and Food Effect in Healthy Adult Subjects

To assess the pharmacokinetics of 3 doses and the food effect of a single high dose of BBI-5000 capsules in healthy adult subjects.

This is an open-label, randomized, 4-period, 4-way crossover, 4-sequence study to evaluate the pharmacokinetics (PK) and food effect of BBI-5000 capsules in healthy adult subjects.

Participating subjects will receive a single oral dose of BBI-5000 followed by a washout period of 7-14 days between doses. The treatment period will be followed by 5-10 day follow-up period.

PK and PD will be assessed by blood sampling through 72 hours postdose.

Safety will be assessed through collection of vital signs, adverse events, physical examination, ECGs and clinical laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* Medically healthy
* 32.0 \>= BMI \>= 18.5 kg/m\^2
* Weight \>= 50 kg for males
* Weight \>= 45 kg for females
* For a female of childbearing potential: either be sexually inactive for 14 days prior to the first dose and throughout the study or be using an acceptable birth control method as dictated by the study
* Willing to comply with protocol and understands study procedures outlined in the ICF

Exclusion Criteria:

* Subject is mentally or legally incapacitated or has significant emotional problems
* History or presence of medical or psychiatric disease
* History of any illness that might confound the results of the study
* History or presence of alcoholism or drug abuse
* History or presence of hypersensitivity or idiosyncratic reaction the the study drug excipient
* History or presence of lactose intolerance
* Pregnant or lactating females
* Seated blood pressure less than 90/40 mmHg or greater than 140/90 mmHg
* Seated heart rate lower than 40 bpm or higher than 99 bpm
* Unable to refrain from or anticipates the use of any drug
* Diet incompatible with the on-study diet
* Donation of blood or significant blood loss within 56 days prior to the first study dose
* Participation in another clinical trial within 28 days prior to the first study dose
Autograft of Human Ovarian Tissue : Efficiency and Safety

Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue.

The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.

Ovarian tissue cryopreservation is a new technique for female fertility preservation before gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments and in vitro follicular growth. At the present time, none mature oocytes were obtained after culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported 8 pregnancy and 6 life birth of healthy babies.

Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.

The general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.

The principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.

Before grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.

After graft, each month hormonal assessment, ovarian echography and, after 3 months, an MRI, will be performed.

Assisted Reproductive Technologies (ART) will be performed in case of heterotopic graft and if necessary in case of orthotopic graft.

The efficiency of ovarian tissue autograft will be appreciated by the delay before the recovery of the ovarian function, the oocyte and embryos qualities in case of ART.

Finally, the number of pregnancies and live births will be also appreciated as well as a possible recurrence of the pathology.

Eligibility Criteria:
Inclusion criteria :

* adult women (age ≥ 18 years old) who stored ovarian fragments before gonadotoxic treatments
* Women who desire to conceive
* Married women or in stable couple
* Cured women or in remission
* Women suffering of Premature ovarian failure
* Consenting women
* women with health insurance

Exclusion criteria :

* age \< 18 years
* women with normal ovarian function
* women with a disease at high risk for ovarian metastasis
* women with contraindication for surgery
* women with contraindication for pregnancy
* not cured women or not in remission
* women without health insurance