cyrilzakka/clinical-trials huggingface dataset:
Bendamustine Hydrochloride Injection for Previously Untreated Chronic Lymphocytic Leukemia

The purpose of this study is to determine whether bendamustine is effective in the treatment of initial treatment of Chronic Lymphocytic Leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a diagnosis of CLL;
* No prior or no standard treatment for CLL;
* Binet stage B, C or symptomatic stage A;
* Needs treatment to control diseases;
* (Eastern Cooperative Oncology Group)ECOG performance status ≤ 2
* Life expectancy ≥3 months
* Written informed consent

Exclusion Criteria:

* Patients were diagnosed with or treated for malignant tumors other than CLL (including active central nervous system lymphoma) within one year prior to entering the study
* Transformation to Richter's syndrome, or prolymphocytic leukemia(PLL)
* Autoimmune hemolytic anemia requiring glucocorticoid therapy
* Autoimmune thrombocytopenia requiring glucocorticoid therapy
* Alanine aminotransferase(ALT)\>3 times upper limits of normal value, Aspartate aminotransferase(AST)\>3 times upper limits of normal value, Total bilirubin(TBIL)\>2 times upper limits of normal value, serum creatinine\>1.5 times upper limits of normal value;
* Other serious Concomitant diseases which affect participation of this study(uncontrolled diabetes, gastric ulcer, cardiac and pulmonary diseases, at active phases of autoimmune diseases;
* Serious or uncontrolled infections;
* Central nervous system dysfunction with clinical symptoms;
* Patients received major surgery within 30 days prior to study entry;
* Pregnant or lactating women
* Allergic to study drug or mannitol
* Participation in any other clinical trials within 3 months prior to study entry
The Sukhshanti Study: Effect of a Sanitation Intervention on Women's Health

The study will measure the impact of sanitation access on women and girl's social and emotional health, behaviors, and quality of life in rural India before and after a sanitation intervention compared to a comparison group that will receive the same intervention at a later date.

This mixed-methods, quasi-experimental study will evaluate the extent to which the Global Sanitation Fund (GSF) sanitation program in Bihar, India improves health and well-being among women and girls. Our study consists of a controlled before-and-after (CBA) study with an embedded ethnography.

Specific objectives are:

* Measure the effect of the GSF intervention on sanitation-related psychosocial stress (SRPS), generalized psychosocial stress (PSS), perceived quality of life, hair cortisol, and urogenital health among women between the ages of 14 and 65.
* Measure changes in sanitation adoption (e.g.: sanitation access and exclusive use) among individuals / households receiving the GSF intervention.
* Document individual and community experiences with sanitation, intervention participation, and latrine coverage through ethnographic methods.

Eligibility Criteria:
Inclusion Criteria:

* between 14 years to 65 years old
* live in geographic area receiving GSF sanitation intervention in 2016
* live in geographic areas matched to intervention communities

Exclusion Criteria:

* less than 25 years old and not reached menarche
* greater than 25 years old and never married
* refusal to participate
Effect of Exercise and Biofeedback on Symptoms of Incontinence in Women With Stress Urinary Incontinence

The overall purpose of this research is to determine the effect of ultrasound imaging biofeedback on urine leakage, pelvic floor muscle contractions, and quality of life in women with stress urinary incontinence. This study will include women 20 years or older with stress urinary incontinence.

The study will involve 2 groups: pelvic floor muscle (PFM) exercises with biofeedback using transabdominal Rehabilitative ultrasound imaging (RUSI) (Group A) and PFM exercises alone (Group B). The participants will perform 16 exercise sessions over a period of 8 weeks. Group A will perform 3 pelvic floor exercises using the transabdominal RUSI to provide biofeedback. Group B will perform the same 3 pelvic floor exercises without biofeedback.

All participants involved in the study will complete a general medical information questionnaire. In addition, all participants will have their PFM contraction assessed using an ultrasound machine placed over the lower abdomen, quality of life assessed with a written questionnaire, and given a 7-day bladder diary to complete prior to, at 4-weeks, and at completion of the study.

This study has been terminated.

Eligibility Criteria:
Inclusion Criteria:

1. women will need to be 20 years or older
2. diagnosed with stress urinary incontinence (SUI).

Exclusion Criteria:

women with:

1. urge or mixed incontinence
2. pelvic organ prolapse
3. previous surgical treatment for incontinence
4. current treatment for SUI (including medications)
5. current pregnancy
6. six months or less postpartum
7. body mass index of ≥ 30
8. recurrent vulvovaginitis
9. current/recurrent urinary tract infections (UTI)
10. non-English speaking.
Exercise Training and Insulin Sensitivity

Regular exercise participation is known to reduce cardiometabolic disease risk but the impact that exercise training has on adipose tissue (AT) metabolism is poorly understood, particularly in humans. It is well established that exercise training improves whole-body glucose levels and increases insulin sensitivity, and this can occur within one or two weeks. These effects are usually due to adaptations in skeletal muscle, the tissue responsible for the majority of glucose disposal. However, many studies have now determined that exercise training also results in adaptations in AT that improve whole-body metabolic health by improving glucose uptake into the AT.

Skeletal muscle is thought to account for approximately 75-85% of glucose uptake , and this process is impaired in .individuals who are insulin-resistant state. It is postulated that the increased level of adiposity that accompanies severe obesity would result in higher dependency on AT for glucose uptake as the AT would be a bigger "sink". Thus the role of AT in inducing whole body insulin resistance is still unclear, particularly in individuals with obesity.

This study will examine the changes in AT glucose uptake before and after 4 weeks of exercise training in obese individuals and establish if there are sex differences.


Eligibility Criteria:
Inclusion Criteria:

* non-smokers, weight stable (\<4 kg) within the last 6 months will be recruited for this study.
* sedentary (not engaged in planned physical activities and performing less than a total of 2 h of physical activity per week during the last 6 months) men and women whose BMI is classified as obese (\>30 kg/m2).

Exclusion Criteria:

* cardiovascular disease, uncontrolled hypertension (no beta blockers), smokers, pregnant, have any recent changes in hormonal birth control, or on any medications known to impact metabolism.
* All participants will be regular sleepers with a duration of 7-9 hours/night.
* Subjects with orthopedic limitations will not be included.
Drug-drug Interaction Study of CTP-543 and Rifampin in Healthy Adult Subjects

This is a Phase 1 open-label study of the effect of rifampin on the pharmacokinetics of CTP-543 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dosing and throughout the study
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at Screening
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs
* If of reproductive age, willing and able to use a medically highly effective form of birth control 30 days prior to first dose, during the study and for 30 days following last dose of study medication
* Understands the study procedures in the informed consent form, and be willing and able to comply with the protocol

Exclusion Criteria:

* History or presence of clinically significant medical or psychiatric condition or disease
* History of any illness that might confound the results of the study or poses an additional risk to the subject by their participation in the study
* History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
* Females who are nursing, pregnant, or planning to become pregnant while in the study, and for 30 days after last dose of study drug
* Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
* A positive test or history of incompletely treated or untreated tuberculosis
* Donation of \> 499 mL of blood or plasma within 56 days of Screening (during a clinical trial or at a blood bank donation) and for 30 days after last dose of study drug
Continuous Versus Discontinuous Design of Encircling Lesions During Ablation for Atrial Fibrillation

Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.

The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Durable PVI is cornerstone for long-term freedom of AF. In one previous study continuous ablation was suggested to be more efficient in durable PVI. However, this hypothesis has not been proven in randomized fashion.

The current study is to confirm whether continuous versus discontinuous design of encircling lesions are comparable under the same conditions of power delivery.

The study design is a two-centre prospective randomized trial to compare the acute efficacy by using the above described approaches.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment.

Exclusion Criteria:

-
Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity

This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.

In patients receiving bariatric surgery, a preoperative liver biopsy will confirm the presence of NASH. Those patients with NASH (histologically defined according the Brunt's criteria) will be randomized to receive metformin (2 times 850 mg orally daily) or placebo for a time period of 1 year. A control liver biopsy will be performed after one year.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving bariatric surgery for obesity

Exclusion Criteria:

* Other causes of liver disease (hepatitis B virus \[HBV\], hepatitis C virus \[HCV\], primary biliary cirrhosis \[PBC\], etc.)
* Patients with diabetes type I
* Patients with endocrinological reasons for obesity (eg. Cushing, etc.)
Asthma and Obesity: Observational

Obesity is associated with poor asthma control and greater healthcare utilization and costs. In this study the researchers will examine the biologic and behavioral interrelationships between these conditions and their impact on outcomes. Towards this end, the researchers will conduct an observational prospective cohort study of 400 obese asthmatic patients treated at institutions in New York City and Denver, and develop and pilot test educational and counseling modules that take an integrated approach to asthma and obesity self-management support.

The objective of this study is to examine novel biological and behavioral pathways that may explain the association of obesity with asthma morbidity, and develop and pilot test educational and counseling modules, based on self-regulation theory, that take an integrated approach to asthma and obesity self-management support.

The Specific Aims are to:

1. Compare the longitudinal relationship between L-arginine/ADMA balance and morbidity (lung function, asthma control, acute resource utilization, and quality of life) between obese adults with late onset asthma vs. (a) obese adults with early onset asthma and non-obese asthmatics with early (b) or late (c) onset disease. Age of asthma onset is as categorized as early when developed ≤12 years of age or late when developed \>12 years of age.
2. Evaluate the interrelationship between obesity- and asthma-related illness beliefs, and the impact of cognitive function, on patients' management of these conditions over time

Eligibility Criteria:
Inclusion Criteria:

* \>21 years with a diagnosis of asthma made by a health care provider and evidence of airway reactivity (increase in FEV1 \>12% and \>200 ml after bronchodilators or positive methacholine test) in prior lung function testing or baseline spirometry;
* prescribed an asthma controller medication;
* English or Spanish speaking.

Exclusion Criteria:

* chronic obstructive lung disease (COPD) or other chronic respiratory illness; - \>15 pack-year smoking history because of the possibility of undiagnosed COPD;
* diagnosis of dementia identified in the clinical record.
Whole-body Hyperthermia for Mild to Moderate Depressive Disorder

The primary aim of this study is to investigate the effectiveness of whole-body hyperthermia in comparison to wait list on depressive symptom severity in patients with mild to moderate depressive disorder currently not under psychotherapeutic or antidepressant drug treatment.

Secondary aims included further quality of life outcomes, immunological parameters, and tolerability/safety of the hyperthermia.


Eligibility Criteria:
Inclusion Criteria:

* Unipolar depression (diagnosed according to the DSM-IV)
* Mild depression: 8-16 points on the HAMD-17 or moderate depression: 17-23 points on the HAMD-17

Exclusion Criteria:

* Current psychotherapy
* Antidepressant drug treatment in the last 4 weeks before study inclusion
* Participants who did not respond to prior antidepressant drug treatment, electroconvulsive therapy, or sleep deprivation (therapy-resistant depression)
* Acute suicidality
* Prior treatment with whole-body hyperthermia
* Contraindications to hyperthermia treatment: acute or feverish infections, severe cardiovascular diseases (e.g. angina pectoris, heart failure, thrombosis, bleeding diathesis), severe gastrointestinal diseases (e.g. renal insufficiency, hepatitis, liver cirrhosis, peptic ulcer), severe neurological diseases (e.g. epilepsy, multiple sclerosis, cerebrovascular malformations or brain tumors), severe endocrine diseases (e.g. hyperthyroidism), or oncological diseases without remission
* Participants taking anti-inflammatory or immunosuppressive drugs
* Participants with severe psychiatric comorbidities (e.g. schizophrenia, schizoaffective disorder, bipolar disorder, dementia, ADHD, obsessive-compulsive disorder, PTSD, alcohol or drug addiction)
* Women during pregnancy and breastfeeding
* Lack of ability to consent
ZX008 Expanded Access Protocol

The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 clinical trials.

The treatment plan consists of an up to 24-month Treatment Period. Access is via application by your health care provider and available at one of the Expanded Access treatment centers. The dose of ZX008 for the duration of the Treatment Period will range from 0.2 mg/kg/day to a maximum of 0.8 mg/kg/day, not to exceed a total daily dose of 30 mg/day; for patients concurrently being prescribed stiripentol, the maximum will be 0.5mg/kg/day, not to exceed a total daily dose of 20 mg/day.

The fenfluramine US Expanded Access Program (US EAP) is available to full-time US Residents only.

Participation in the US EAP is limited to patients currently residing in the US. Residency in the US must be for the duration of participation in the US EAP. Drug may not be shipped outside the US.

Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female, age 2 years and older, inclusive as of Study Day 1.
* Patient is diagnosed with Dravet syndrome.
* Patient is experiencing convulsive seizures which are not controlled by current AEDs.
* Patient is receiving at least one AED and will remain on at least one AED for the duration of treatment.
* Patient has been approved for inclusion by Zogenix.

Exclusion Criteria:

* Patient requires or starts using an unacceptable or contraindicated concomitant medication.
* Patient has valvulopathy.
* Patient is at risk for pulmonary hypertension.
* Patient exclusion will be at the sole discretion of the Sponsor.
Phase Ⅱ Clinical Study of R435 (Bevacizumab) in Combination With Paclitaxel in Patients With Inoperable Metastatic Breast Cancer

To investigate the efficacy, safety, and pharmacokinetics when R435 and paclitaxel are administered concomitantly to patients with metastatic breast cancer.


Eligibility Criteria:
* At least 20 years old and obtained a written informed consent
* Advanced breast cancer (StageⅣ) or Inoperable metastatic breast cancer
* HER2 negative
* At least one measurable lesion based on RECIST criteria
* No previous chemotherapy for metastatic breast cancer
Sublingual Microcirculation Change During Pregnancy and Postpartum Period

Sublingual microcirculation change in pregnant women with or without high risk pregnancy factors during pregnancy and postpartum period.

Microcirculation system is composed of a group of blood vessels less than 100 um in diameter composed of arterioles, capillaries, veins and other structures. The health of microcirculation system correlates well with the stability of systemic circulation. Perfusio of microcirculation is often affected by major diseases such as sepsis, shock and heart disease. Through various microcirculation monitoring instruments, the investigators can assess the disease severity and prognosis.

Physiological changes during pregnancy will increase the blood volume, stroke volume, and microcirculation. Preeclampsia refers to the development of hypertension (systolic blood pressure\> 140 mmHg, diastolic blood pressure\> 90 mmHg) after 20 weeks of gestation with proteinuria. Severe preeclampsia is associated with impaired endothelial cell circulation throughout the body, and reduced sublingual microcirculation perfusion.

Through the sublingual microcirculation monitor, studies have shown that pregnant women have more microcirculation perfusion than non-pregnant women, while women with severe preeclampsia and those with HELLP syndrome have impaired microcirculation.

This study aims to investigate whether there is any change in the sublingual microcirculation before and after labor in healthy pregnant women and high-risk pregnant women (such as epilepsy, gestational diabetes, etc.) through the third generation of microcirculation imaging microscope (cytocam).

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women older than 20 years old who will delivery baby in our hospital (both normal spontaneous delivery and cesarean section).
* Women over 20 years of age who will delivery baby in our hospital (both normal spontaneous delivery and cesarean section) and meet the definition of high-risk pregnancy such as gestational diabetes mellitus, placenta previa, placenta accreta, gestational hypertension, preeclampsia or severe preeclampsia.

Exclusion Criteria:

* Chronic hypertension or diabetes
Caisson Transcatheter Mitral Valve Replacement (TMVR)

The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).

The treatment guidelines for valvular heart disease indicate that surgical correction of primary mitral valve regurgitation (MR) is a Class I recommendation. Recent evidence indicates that valve replacement is at least as effective as repair in both primary and secondary MR patients. However, many patients are not referred for surgery as they are considered to be too high of a risk to undergo on-pump, open-heart procedures. Percutaneous aortic valve replacement has made treatment of stenosed aortic valves available to high-risk surgical patients who would have otherwise been medically managed. Percutaneous mitral valve (MV) replacement offers similar advantages. The feasibility of percutaneous MV replacement has been demonstrated in early feasibility studies. To meet this medical need, Caisson Interventional has developed a percutaneous delivery system for a bioprosthetic mitral valve. As with patients with aortic valve (AV) deficiencies, this device can be used to provide needed therapy to patients who might not otherwise receive treatment beyond medical therapy. This study will provide information on the safety and performance of this system.

Eligibility Criteria:
Inclusion Criteria:

* Has severe mitral regurgitation
* New York Heart Association (NYHA) Class II, III, IVa or heart failure
* High risk for cardiovascular surgery

Exclusion Criteria:

* Excessive calcification or thickening of mitral valve annulus
* Severe mitral stenosis, fused commissures, valvular vegetation or mass
* Left ventricular end diastolic dimension \> 7cm
* Left ventricular outflow tract obstruction
* Severe right ventricular dysfunction
* Stroke within 90 days; transient ischemic attack or myocardial infarction within 30 days of the index procedure
Toward Understanding Drivers of Patient Engagement With Digital Mental Health Interventions - Part II

This study is a clinical trial that evaluates what drives patient engagement and tests the impact of two strategies-automated motivational push messaging and coach support-to improve engagement with an evidence-based mobile app intervention for depression and/or anxiety.

This 8-week, clinical trial involves primary care patients with clinically significant depression and/or anxiety recruited via provider referral. Participants will received access to a digital mental health intervention with known efficacy and be randomized to an engagement strategy condition--a previously-validated Coach Support protocol (CS), a newly-developed automated motivational messaging protocol (AMM), both or neither. To further understand how messages in the AMM arms function, message delivery will be micro-randomized: each day participants will be randomized to receive a message or not, such that they receive an average of 4.2 messages/week. Micro-randomization allows causal inference about the near-term impact of message delivery (i.e., are AMMs a cue to action) and the relationship between message impact and context (e.g., day in study). Measured outcome data will include level of engagement (operationalized as minutes of intervention use) and weekly self-reports of clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Mass General Brigham primary care patient
* Age 18-75
* Clinically significant symptoms of depression (Patient Health Questionnaire-9 (PHQ-9) greater than or equal to 10) and/or anxiety (Generalized Anxiety Disorder-7 (GAD-7) greater than or equal to 8)
* Owns a smartphone capable of running the study applications
* Fluent in English.

Exclusion Criteria:

* Diagnosis of bipolar I or bipolar II disorder per patient report or the patient's medical record
* Diagnosis of any psychotic disorder per patient report or the patient's medical record
* Current substance use disorder per patient report or the patient's medical record
* Acute and/or unstable medical problem that may interfere with participation (e.g., scheduled for surgery in the next two months).
Comparison of Peak Airway Pressure and Gastric Insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation With I-Gel in Pediatric Patient

The purpose of this study is to compare peak airway pressure and gastric insufflation in Pressure-Controlled Ventilation or Volume-Controlled Ventilation with I-Gel in pediatric patient


Eligibility Criteria:
Inclusion Criteria:

① ASA I-II patients aged between 1 and 7 year undergoing elective urologic surgery.

Exclusion Criteria:

* parent refusal

  * clinically significant respiratory disease ③ congenital airway abnormalities, oropharyngeal or facial pathology ④ risk of aspiration