cyrilzakka/clinical-trials huggingface dataset:
A Study of Aleglitazar in Type 2 Diabetes Patients With Moderate Renal Impairment

This multi-center, randomized, double-blind, active controlled, parallel-group study in type 2 diabetes patients with moderate renal impairment will evaluate the effect on renal function and the safety and tolerability of aleglitazar compared with pioglitazone. Patients will be randomized to receive either 150 mcg aleglitazar or 45 mg pioglitazone as daily oral doses. In addition, a diet and exercise plan will also be implemented during the anticipated time on study treatment of 52 weeks. The target sample size is 200-400 patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \>/= 18 years of age
* Diabetes mellitus, Type 2
* Moderately impaired kidney function
* Drug naive or up to 2 antihyperglycemic medications at stable dose for over 1 month at screening
* BMI 25-35

Exclusion Criteria:

* Current or previous treatment with a thiazolidinedione
* Current or previous treatment with insulin
* Treatment with fibrates \<3 months prior to screening
* History of renal disease other than diabetic nephropathy
Structure and Function of Salivary Proteins

This study seeks to provide point-of-care clinical diagnostic systems for the diagnosis of current disease status using saliva as a sample specimen.

The overall hypothesis of this study is that whole saliva and its components, due to its direct anatomic relation to the airways, provides a window on the composition and nature of the disease-specific response in the bronchial, sinus, and nasal airways. By examining proteins created in saliva, we hope to validate that saliva is an important diagnostic tool for for rapid analysis of respiratory status. We further propose that rapid salivary diagnostics will improve patient care in prevalent respiratory diseases with frequent health care utilization and high morbidity, such as asthma, chronic obstructive pulmonary disease (COPD), and cystic fibrosis (CF).

Eligibility Criteria:
Inclusion Criteria:

* 6 or more years of age
* confirmed Cystic Fibrosis

Exclusion Criteria:

* Pregnant
Osteoarthritis in Terms of ICF Components

Osteoarthritis (OA) is a common degenerative disease associated with functional impairments, activity limitations, participation restrictions, as well as poor quality life. Therefore, the comprehensive assessment is important to determine how complex problems affect patients with OA. The first aim of this study was to link and allocate items of The Western Ontario and McMaster Universities (WOMAC) OA index with ICF Comprehensive Core Set for osteoarthritis. The second aim was to examine the relationship between the quality of life and each ICF component's scores determined based on clinical data of WOMAC in OA.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with OA according to American College of Rheumatology clinical criteria for OA of the knee or hip;\[14,15\]
* being in the age range 18-65; and
* absence of other diseases affecting functions and daily life (orthopedic, neurological, cardiovascular, metabolic disease and lung pathology).

Exclusion Criteria:

* comorbidity affecting lower extremity and functions (patellofemoral pain syndrome, rheumatoid arthritis, ligament tear, meniscus);
* previous lower extremity surgery;
* Intra-articular steroid or hyaluronic acid injection in the last three months
* cognitive impairments;
* pregnancy; and
* illiteracy.
Safety and Efficacy Study of LUM001 in the Treatment of Cholestatic Liver Disease in Patients With Alagille Syndrome

The study is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of LUM001. Efficacy will be assessed by evaluating the effect of LUM001 versus placebo on the biochemical markers and pruritus associated with Alagille Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Alagille Syndrome
2. Evidence of cholestasis
3. Moderate to severe pruritus
4. Ability to understand and willingness to sign informed consent/assent prior to initiation of any study procedures

Exclusion Criteria:

1. Surgical disruption of the enterohepatic circulation
2. Liver transplant
3. History or presence of other concomitant liver disease
4. Females who are pregnant or lactating
5. Known HIV infection
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.

The study is intended to assess the safety and efficacy of Carbon dioxide AcuPulse laser treatment in patients with sexual dysfunction. Eligible subjects will be randomized to either receive 3 laser or 3 sham treatment sessions, 4 weeks apart and 3 follow up visits 3, 6 and 12 months following the last treatment.

Following a screening visit, eligible subjects will be enrolled into the study. Subjects will be randomized into either laser treatment or sham treatment. Each subject will receive 3 treatments 4 weeks apart and 3 follow up visits, at 3, 6 and 12 months following the last treatment.

Further demographic information and patient history will be obtained from the subjects' electronic files.

Eligibility Criteria:
Inclusion Criteria:

* Negative urine analysis.
* Normal Pap smear test from the recent 3 years.
* No previous gynecological laser treatments.
* Able and willing to comply with the treatment/follow-up schedule and requirements.

Exclusion Criteria:

* Active genital infection.
* Subject presenting abnormal Pap result from the last three years.
* Recurring urinary tract infection or recurring infection of genital herpes or candida (\> 2 episodes in the recent year).
* Transvaginal mesh implant.
* Serious systemic disease or any chronic condition that could interfere with study compliance.
* Any vaginal bleeding of unknown reason.
Chloroquinoxaline Sulfonamide in Treating Patients With Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of chloroquinoxaline sulfonamide in treating patients who have small cell lung cancer that has not responded to platinum-based chemotherapy.

OBJECTIVES: I. Determine the efficacy of chloroquinoxaline sulfonamide in patients with platinum-refractory small cell lung cancer. II. Determine the toxic effects of this drug in these patients.

OUTLINE: Patients receive chloroquinoxaline sulfonamide IV over 1 hour once a week for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed until death.

PROJECTED ACCRUAL: A total of 12-38 patients will be accrued for this study within 12-18 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed platinum-refractory small cell lung cancer No response or progression during or within 6 months of completing platinum based therapy Measurable disease No symptomatic brain or leptomeningeal metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 No hemolytic anemia Hepatic: Bilirubin normal AST no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of cardiac arrhythmias Other: No other active malignancy requiring concurrent treatment No allergy to sulfonamides Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more than 2 prior chemotherapy regimens At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: No concurrent corticosteroids to control symptoms of brain and/or leptomeningeal metastases Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy to measurable lesions Surgery: Not specified Other: No concurrent hypoglycemic agents (including insulin)
Zolpidem Tartrate 10 mg Tablets Under Non-Fasting Conditions

The objective of this study is to compare the relative bioavailability of Zolpidem tartrate 10 mg tablets (manufactured by TEVA Pharmaceutical Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of AMBIEN® tablets(G.D. Searle \& Co.) in healthy, adult, non-smoking subjects under non-fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (body mass index) of 30 or less.

Exclusion Criteria:

* Subjects with a significant recent history of chronic alcohol consumption, drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular disease, tuberculosis, epilepsy, asthma, diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result to not be significant.
* Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
* All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
* Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
* All Female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
Impact of Empagliflozin on Functional Capacity in Heart Failure with Preserved Ejection Fraction

Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors generally and empagliflozin specifically have shown cardiovascular benefits in patients with heart failure (HF), but the underlying mechanisms remain unclear. Empagliflozin use resulted in lower pulmonary artery diastolic pressures in patients with HF, suggesting a beneficial diuretic effect. Other potential mechanisms include increased blood volume, decreased blood pressure, and changes in sympathetic and neuro-hormonal activation.

This study is a single-arm, open label, prospective interventional study of 8 subjects with heart failure with preserved ejection fraction (HFpEF). Before and after 12 weeks of daily empagliflozin, participants with undergo comprehensive invasive exercise testing with a right heart catheter. Our goal is to evaluate the effects of empagliflozin on fitness, assessed by peak VO2, and peak left ventricular filling pressure, assessed by pulmonary capillary pressure at peak exercise.

This is a single-arm, open label, pilot study of 8 subjects with HFpEF. The subjects will undergo screening tests (exercise stress echo and blood work) to evaluate for potential exclusion criteria and provide familiarization to the exercise protocol. Those included will undergo an echocardiogram and invasive cardiopulmonary exercise test. This involves placement of a right heart catheter in the pulmonary artery and undergoing seated, upright exercise. During the exercise test, the subject's oxygen uptake (VO2), intra-cardiac pressures (right atrial pressure, pulmonary capillary wedge pressure) and cardiac output (Qc) will be measured. The subject will take a dose of empagliflozin in the lab and wait for at least 60 minutes. They will repeat a shortened version of the exercise test in the afternoon. After baseline testing, each subject will take 10mg empagliflozin daily for 12 weeks. They will have repeat blood work (specific electrolytes and renal function) 30 days after starting medication to screen for renal injury. After 12 weeks, they will return for another invasive cardiopulmonary exercise test and echocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* adults ages 50-85
* clinical heart failure
* ejection fraction \> 50%

Exclusion Criteria:

* previous hypersensitivity or adverse reaction to SGLT-2 inhibitors
* currently treated with SGLT-2 inhibitor
* current or prior ejection fraction \<50%
* chronic kidney disease with glomerular filtration rate \< 45 ml/kg/min
* unstable coronary artery disease
* significant arrhythmia
* BMI \>55 kg/m2
* inability to exercise.
Pain Control Using Neuromodulation in Patients Undergoing Definitive Chemoradiotherapy for Head and Neck Cancer

The purpose of this study is to determine if Transcranial Direct Current Stimulation (tDCS) can reduce pain perception associated with the effects of receiving definitive radiation therapy or chemoradiotherapy in head and neck cancer (HNCa) patients.

The goal of this study is to investigate the effectiveness of tDCS as a novel pain relief modality for odynophagia due to mucositis in patients with locally advanced head and neck cancer undergoing definitive radiation therapy or chemoradiotherapy. Participants will be randomized into one of two arms: (1) Treatment: radiation/chemoradiotherapy standard of care + tDCS neuromodulation or (2) Control: radiation/chemoradiotherapy standard of care only.

Patients in the treatment arm will undergo tDCS stimulation on the day of their radiation/chemoradiotherapy appointments, prior to receiving treatment when doing tDCS session in clinic or after to receiving treatment when doing tDCS session at home. This will occur daily (5 days per week) during the second and third weeks of therapy, three times per week during the fourth and fifth weeks, and twice per week during the sixth and seventh weeks.

Patients will also have EEG and fNIRS recordings during the study. This will occur at the pre-study visit, the first stimulation appointment, the third week, the 7th week, and during the follow-up appointments (one-week and one-month).

Eligibility Criteria:
Inclusion Criteria:

* Patients with AJCC stage III-IV head and neck malignancy scheduled for definitive radiation therapy or chemoradiotherapy, and who are capable of understanding and adhering to the protocol requirements.

Exclusion Criteria:

* Substantial dementia
* Patients are actively being treated for another cancer at the time of enrollment.
* Any condition that would prevent use of tDCS including skull abnormality, implanted metal, implanted electronic device, seizure disorder, neurologic condition.
* Use of an investigational drug or device within 30 days of study screening
The Use of Leukapheresis to Support HIV Pathogenesis Studies

Despite the dramatic improvements that have resulted from combination antiretroviral treatment, long-term efficacy, toxicity, cost, and the requirements for life-long adherence remain as formidable challenges. Also, there is emerging consensus that persistent HIV-associated disease occurs during long-term highly active antiretroviral therapy (HAART). This disease may be due to either direct drug-toxicity and/or persistent viral replication/production and/or persistent HIV-associated inflammation. Hence, strategies aimed at achieving complete viral eradication may be needed in order to fully restore health among HIV infected individuals. Even if complete eradication proves impossible-as most believe to be the case-a less rigorous but still desirable outcome might be achieving durable control of virus in the absence of therapy. That a "functional" cure is possible is well illustrated by those rare individuals who are able to durably control replication competent virus in the absence of therapy ("elite" controllers).

A more complete understanding of the relationship between inflammation and viral persistence is necessary before more rationale studies of HIV eradication can be designed. Also, a well validated high through-put virologic assay needs to be developed that can estimate the size of the latent reservoir. Since the level of replication competent virus in long-term treated patients (and in elite controllers) is very small (\< 1% of CD4 cells harbor HIV), large numbers of CD4+ T cells most be obtained from study participants in order to routinely isolate and quantify virus persistence.


Eligibility Criteria:
Inclusion Criteria:

* HIV seropositive
* Able to give informed consent
* Willing to undergo blood sampling and/or leukapheresis
* Meeting one of the following criteria: (1) on stable highly active antiretroviral therapy (HAART) with a recent undetectable viral load (\< 50 copies/mL) ("HAART suppressed"), (2) antiretroviral untreated with an undetectable viral load (\< 50 copies/mL) ("elite" controllers) and (3) antiretroviral untreated with a detectable viral load (\> 1000 copies/mL) ("non-controllers")

Exclusion Criteria:

* Known anemia (HIV+ males Hct\<34; females Hct\<32) or contraindication to donating blood
* Blood coagulation disorder (including bleeding tendency or problems in past with blood clots)
* Platelets \< 50,000/mm3
* PTT \> 2x ULN
* INR \> 1.5
* Albumin \< 2.0 g/dL
* ALT \> 5x ULN
* AST \> 5x ULN
* Biopsy-proven or clinical diagnosis of cirrhosis
* Weight \<120 lb
* High blood pressure \> 160/100
* Low blood pressure \< 100/70
* Pregnant
Parenteral Nutrition Support for Patients With Pancreatic Cancer

The purpose of this study is to determine whether the additional nutrition support is improving the nutritional status of patients suffering cancer caxechia or not.

To examine the impact of additional parenteral nutrition (APN) we prospective evaluated 32 pts suffering APC and progressive cachexia. This assay is based on a bioelectrical impedance analysis (BIA) as a proven tool for nutritional investigation in patients with chronic disease. Phase angle, determined by BIA, has been found to be a prognostic indicator in several chronic and malignant conditions, such as HIV, liver cirrhosis, chronic obstructive pulmonary disease lung cancer and pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* histological proved pancreatic cancer
* progressive cancer cachexia
* refractive to enteral supplementation
* informed consent

Exclusion Criteria:

* prefinal status
* septic disease
GTx-024 as a Treatment for Stress Urinary Incontinence in Women

The purpose of this study is to determine whether GTx-024 is safe and effective in the treatment of stress urinary incontinence in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary, written and signed, informed consent
* Female
* Age18 to 80 years old be clinically confirmed as postmenopausal. Subjects must have undergone the onset of spontaneous, medically induced or surgical menopause prior to the start of this study. Spontaneous menopause is defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/ml or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
* SUI symptoms for at least 6 months duration
* Predominant SUI (MESA questionnaire)
* 24 hour pad weight \>3 gms at baseline
* A minimum of 1 SUI episode per day, in the 3 day diary
* 3-15 SUI episodes per day, averaged over 3 days, in the 3 day diary
* Serum AST and ALT within normal limits
* Total bilirubin within normal limits
* Positive Bladder Stress Test during screening
* Subject agrees to not start any new treatment (medication or otherwise) that is known to affect lower urinary tract function throughout the treatment and follow up periods
* Subject agrees to maintain on a stable dose of any medication known to affect lower urinary tract function, including but not limited to anticholinergics, tricyclic antidepressants, or alpha-adrenergic blockers, throughout the treatment and follow-up period

Exclusion Criteria:

* Pelvic floor physical therapy in a clinical setting within 30 days prior to screening
* History of pelvic radiation treatment
* History of urethral diverticula
* History of urethral sling, anterior prolapse repair, ureteral bulking agents and/or other SUI procedure or surgery
* Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant urological findings, including pelvic floor abnormalities which, in the judgement of the investigator, could impact treatment
* Urinary incontinence of neurogenic etilogy
* Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or body mass index 40 or greater)
* Chronic hepatitis
* Hepatic cirrhosis
* HIV and/or hepatitis A, B, or C
* Subjects taking systemic hormone products
* Subjects with a history of breast or endometrial cancer
* Myocardial infarction or arterial thromboembolic events within 6 months prior to Baseline, severe or unstable angina, New York Heart Association (NYHA) Class III or IV disease, serious uncontrolled cardiac arrhythmia grade II or higher according to NYHA, uncontrolled hypertension (systolic \> 150 and/or diastolic \> 100 mm Hg)
* Subjects with an entry measurement of \> 5 mm endometrial stripe thickness
* Clinically confirmed urinary tract infection
* Any other condition which per investigators' judgment may increase subject risk
Electromyographic and Acceleromyographic Monitoring in Restricted Arm Movement Surgical Setting

Researchers are comparing the ease of use and repeatability of the force vs electrical activity produced by a muscle after it has undergone nerve stimulation during a surgical procedure in which the patients' arm movement is restricted (placed under surgical drapes) in laparoscopic or robotic procedures.


Eligibility Criteria:
Inclusion Criteria:

* Age \> or = 18 years old
* Patients willing to participate and provide an informed consent
* Patients undergoing an elective laparoscopic or robotic surgical procedure that requires use of NMBA agents administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents, i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm or leg into the sterile field