cyrilzakka/clinical-trials huggingface dataset:
GS-6615 in Adults With Chronic Stable Angina and Coronary Artery Disease

This study will evaluate the effect of GS-6615 in adults with chronic stable angina and coronary artery disease (CAD) receiving a stable daily dose of up to 2 antianginal medications. The study will consist of two periods: a 1 to 3 week Qualifying Period and a Treatment Period lasting 13 days (± 3 days). During the Qualifying Period and at the end of the Treatment Period, participants will undergo exercise tolerance testing.


Eligibility Criteria:
Inclusion Criteria:

* Able to perform a standardized treadmill exercise protocol
* At least a 3 month history of chronic stable angina triggered by physical effort and relieved by rest and/or short-acting nitroglycerin
* Coronary artery disease (CAD) documented by one or more of the following:

  * Angiographic evidence (either invasive or noninvasive) of ≥ 50% stenosis of one or more major coronary arteries
  * History of myocardial infarction (MI) documented by positive creatine kinase-myocardial band (CK-MB) enzymes, troponins, or electrocardiogram (ECG) changes
  * Noninvasive imaging stress test diagnostic of CAD (eg, nuclear perfusion scan, stress echocardiogram, stress cardiac magnetic resonance scan)
* Stable antianginal treatment with up to 2 antianginal agents

Exclusion Criteria:

* Inability to exercise or having exercise limitation due to other co-morbidities that may interfere with ability to perform required exercise tolerance testing (ETT)
* Presence of electrocardiographic or other abnormalities that interfere with ECG interpretation or may cause a false positive stress test
* History of heart failure as defined by New York Heart Association Class III-IV and/or known left ventricular ejection fraction ≤ 45%
* History of severe disabling angina as defined by Canadian Cardiovascular Society Class IV
* Myocardial infarction, acute coronary syndrome or coronary revascularization within 3 months prior to screening, or planned coronary revascularization during the study period
* Stroke or transient ischemic attack within 6 months prior to screening
* Chronic persistent atrial fibrillation
* Uncontrolled hypertension (seated systolic blood pressure (SBP) \> 160 mm Hg or diastolic blood pressure (DBP) \> 110 mm Hg)
* Body mass index (BMI) ≥ 36 kg/m\^2
Glycemic Response to Different Food Combinations

The purpose of this study is to assess the impact of combining starch rich foods with low pH foods on the glycemic response to meals

Low pH foods can attenuate the glycemic response to starch-rich foods. It has been demonstrated that lemon juice, due to its low pH (pH≈2.3) inhibited key digestive enzymes thereby interrupting gastric digestion of starch in vitro. This effect can significantly reduce the glycemic response in humans. In particular, adding lemon juice to a starch rich meal reduced the mean blood glucose concentration peak by 30%.

Considering the panoply of food options available, it is likely that other combinations have similar effects but no work has been conducted to develop a consolidated knowledge base to exploit this strategy. GlucoMatchMaker will go beyond the state-of-the art by addressing this knowledge gap. The main goal is to develop and test the real-life impact of pH-based food combination strategies on glycemic responses.

Eligibility Criteria:
Inclusion Criteria:

* Subject has given written informed consent
* Subject is available to participate in the study sessions on the proposed dates.

Exclusion Criteria:

* Subject has an allergy or intolerance to any food and/or ingredient in the study meals
* Body mass index ≤ 18.5 kg/m2 or ≥ 30.0 kg/m2.
* Diagnosed mouth, throat or active gastrointestinal pathology that may affect normal ingestion and digestion of food.
* History of pancreatic disease
* Subject is immunocompromised (HIV positive, transplant patient, on antirejection medications, on a steroid for \>30 days, or chemotherapy or radiotherapy within the last year).
* Subject has Type 1 or Type 2 diabetes mellitus or pre-diabetes.
* Subject has a history of drug and/or alcohol abuse at the time of enrolment.
* Subject is currently taking medication that can effect glucose metabolism and/or normal gastrointestinal function.
* Subject is currently participating in another study, or plans to participate in another study during the study period.
* Women of child-bearing potential who do not use an acceptable method of contraception.
* Pregnant or nursing (lactating) women.
Study Comparing Venlafaxine vs. Paroxetine in Panic Disorder

The purpose of this pilot study is to evaluate the improvement in social function following therapy with venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine. An additional purpose of this pilot study is to obtain the tolerability of using venlafaxine extended release (XR) in the treatment of panic disorder (PD) in comparison to paroxetine.


Eligibility Criteria:
Inclusion Criteria:

* Meet DSM IV criteria for Panic Disorder (with or without agoraphobia) for at least 3 months before study day 1.
* Have a minimum of 8 full-symptom panic attacks during the 4 weeks before the screening visit.
* Provide a written informed consent

Exclusion Criteria:

* Treatment with Venlafaxine within 6 months of study day 1, as well Paroxetine
* Known hypersensitivity to Venlafaxine or related compounds as well to Paroxetine.
* Psychopharmacologic drugs within 14 days of study day 1
MOre REsponse on Cardiac Resynchronization Therapy With MultiPoint Pacing

The purpose of this Clinical investigation is to assess the impact of the Multi Point Pacing (MPP) feature at 12 months in the treatment of patients not responding to standard Cardiac Resynchronization Therapy (CRT) after 6 months.

This study is designed as a prospective, randomized, multi-center trial. Data will be collected at enrollment, baseline, implant procedure, patient classification, 6 months and 12 months of follow-up. During the 6-month visit, the patient's response to CRT will be evaluated according to LVESV reduction. Patients with an LVESV reduction of at least 15% will be classified as responders. These patients will terminate their participation in the study and return to the center's standard practice. Patients with an LVESV reduction less than 15% will be classified as non-responders and the MPP feature will be activated according to randomization result and they will be followed until the 12-month visit.

Eligibility Criteria:
Inclusion Criteria:

* Meets the current ESC Guidelines or ACCF/AHA/HRS Class I or Class IIa indications for CRT implant (including upgrades from single or dual chamber ICDs)
* Must be willing and able to comply with study requirements
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria:

* Already had a CRT device implanted
* Myocardial Infarction, unstable angina within 40 days prior the enrollment
* Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
* Primary valvular disease
* Atrial Fibrillation:

  * Persistent AF at the time of enrollment
  * Permanent AF not treated with AV node ablation within 2 weeks from the CRT implant
  * History or incidence of Paroxysmal or Persistent AF within 30 days prior the enrollment
* Unable to comply with the follow up schedule
* Less than 18 years of age
* Pregnant or are planning to become pregnant during the duration of the investigation
* Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
* Undergone a cardiac transplantation
* Life expectancy \< 12 months
* Currently participating in any other clinical investigation
NORDIC: Nitric Oxide-Derived Oxidants and Regional Endothelial and Diastolic Dysfunction in Dilated Cardiomyopathy

The principal aim is to investigate the safety and efficacy of rosiglitazone in patients with chronic systolic heart (Dilated cardiomyopathy). We hypothesize that in patients with heart failure, rosiglitazone is safe, and can reduce nitric oxide (NO) derived oxidative stress (in particular, nitrotyrosine) thereby improving endothelial dysfunction, left ventricular performance, and metabolic parameters.

The study will be a single center, double-blind, prospective placebo controlled trial of 60 non-diabetic heart failure patients. Prior to administration of study medication, a medical history, physician exam, blood draw, laser Doppler imaging (Periscan system), venous occlusion strain gauge plethysmography, metabolic exercise stress test and 2D and 3D echocardiograms will be performed. Patients will then be randomized to receive rosiglitazone 2mg/day oral versus placebo with up-titration to 4mg/day oral versus placebo at 3 months. Each study arm will have 30 patients who will participate for 6 months. Follow up assessments will be completed at 6 weeks, 3 months and 6 months post randomization.

Eligibility Criteria:
Inclusion Criteria:

Patients enrolled into the trial must meet all of the following criteria:

1. Chronic, stable, euvolemic, heart failure optimally treated for at least 3 months with stable doses of ACE inhibitors or angiotensin-receptor blockers and beta-blockers
2. Mild-to-moderate signs and/or symptoms of heart failure (NYHA functional Class I-II)
3. Left ventricular ejection fraction of \<40% by echocardiogram within 6 months of randomization or enrollment

Exclusion Criteria:

Patients meeting one or more of the following criteria are not eligible for randomization into the trial:

1. Known or confirmed newly-diagnosed diabetes mellitus (2004 ADA criteria)
2. Major cardiovascular event (myocardial infarction, unstable angina, stroke, transient ischemic attack, pulmonary embolism), or major surgery \<1 month of enrollment
3. Hospitalization or emergency room visits for heart failure exacerbation, or use of inotropic agents \< 1 month
4. NYHA class III or IV
5. Current treatment with thiazolidinediones
6. Allergy to rosiglitazone, or liver insufficiency (ALT \> 2.5x upper limits of normal)
7. Heart failure due to congenital heart disease, primary valvular disease, hypertrophic cardiomyopathy, or heart failure caused by known cardiotoxic agents (e.g. adriamycin)
8. End-stage renal failure on renal replacement therapy (dialysis)
9. Life expectancy, or expected cardiac transplantation within 12 months of enrollment
10. Women who are pregnant, or who are planning on becoming pregnant or are lactating. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the time of randomization and must use contraceptive agents
11. Unable or unwilling to consent to all components of the protocol. Patients unwilling to undergo 6-month follow-up should not be enrolled.
The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)

To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.

First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2) antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for HIV assay in patients with tumor and hematological diseases was calculated.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of tumor Disease or blood disease
* Blood samples must meet the test requirements

Exclusion Criteria:

* N/A
PTA vs. Primary Stenting of SFA Using Self-Expandable Nitinol Stents

The investigators evaluated whether primary implantation of a self-expanding nitinol stent yielded anatomical and clinical benefits superior to those afforded by percutaneous transluminal angioplasty with optional secondary stenting.


Eligibility Criteria:
Inclusion Criteria:

* symptomatic peripheral artery disease with severe intermittent claudication (Fontaine stage IIb)
* critical limb ischemia in patients with stenosis or occlusions originating in the SFA
* up to 25 cm length of stenosis/occlusion

Exclusion Criteria:

* previous bypass surgery at the site of treatment
* history of intolerance of anti-platelet therapy
* adverse reaction to heparin
* bleeding diathesis
* creatinine \>2.5 mg/dL
* active bacterial infection
* allergy to contrast media
* previous stent placement at or immediately adjacent to the target lesion
Pegfilgrastim on Day +3 Compared to Day +1 After Salvage Chemotherapy for Patients With Refractory or Relapsed Aggressive Lymphoma

Granulocyte colony stimulating factors (GCSFs) stimulate the level of white blood cells, specifically neutrophils. GCSF support for patients receiving chemotherapy was shown to decrease the rate of fever during low neutrophil count (neutropenia), and in some cancer types may decrease mortality. Pegfilgrastim is a pegylated form of the GCSF named filgrastim. Pegfilgrastim is used to stimulate bone marrow to produce more neutrophils to fight infection in patients undergoing chemotherapy. It has a much longer half-life than the parent filgrastim. It is removed from the body within the neutrophils. According to the American Society of Clinical Oncology 2006 guidelines pegfilgrastim should be given 24 hours after the completion of chemotherapy i.e.before neutrophil count starts to drop. Therefore it is cleared before and after neutropenia. Comparative low quality studies suggest that deferring pegfilgrastim delivery until neutrophil counts start dropping may result in improved its efficacy. This was further tested in a few small randomized controlled trials (high quality studies, considered the "gold standard" of studies) in different settings (including first chemotherapy for lymphoma, and solid cancer) with inconsistent results. Pegfilgrastim (given 24 hours after completion of chemotherapy) is a standard part of any salvage chemotherapy for patient with refractory or relapsed aggressive lymphoma. The investigators plan a randomized controlled trial comparing the efficacy of pegfilgrastim given 72 hours (day +3) vs. 24 hours (day +1) after completion of salvage chemotherapy in patients with refractory or relapsed aggressive lymphoma. The investigators will evaluate whether that change of pegfilgrastim schedule affects the risk of fever during neutropenia, neutrophil count, length of hospitalization, mortality, and safety.


Eligibility Criteria:
Inclusion Criteria:

Adult patients (age 18 years or above)

* Refractory or relapsed aggressive lymphoma, including Hodgkin's and non-Hodgkin's lymphoma
* Candidate for salvage chemotherapy. Salvage chemotherapy includes one of the following regimens: Ifosfamide, etoposide, vincristine (ICE), Cisplatin, cytarabine, and dexamethasone (DHAP), Etoposide, methylprednisolone, cytarabine, cisplatin (ESHAP). Chemotherapy dose reduction will be allowed.
* Chemotherapy with or without immunotherapy
* Therapy in hospital or at the outpatient clinic

Exclusion Criteria:

* Indolent lymphoma; we will exclude patients with transformed lymphoma.
* Treatment with GCSFs for the primary disease (e.g. aplastic anemia, MDS).
* Uncontrolled infection
* Pregnant women
Three Dietary Regimens in Pre-colonoscopic Bowel Preparation in Children

To describe the feasibility and effectiveness of three dietary regimens in precolonoscopy bowel preparation in children

The accuracy of endoscopic diagnosis and treatment of safety depends largely on the intestinal cleaning quality. Qualified bowel preparation is a prerequisite for clear vision during colonoscopy. Presently, the common diet for children before colonoscopy in China is a liquid or low residual diet. The liquid and low residual diet often have poor taste and satiety, often resulting in poor compliance of children, especially young children, who are often unwilling to eat a liquid diet, resulting in insufficient caloric supply and unstable blood glucose during bowel preparation. Enteral formula as a kind of high-energy and low-fiber diet has been applied in clinical practice. Currently, there is no comparison between liquid diet, low-residue diet, and enteral formulas in children's bowel preparation in China. Dietary restriction is an indispensable part to ensure the success of the bowel preparation program. There is an urgent need to conduct research on the application of various dietary programs in children's bowel preparation before colonoscopy in China. In order to provide high-quality evidence for the bowel preparation diet program for children.

Eligibility Criteria:
Inclusion Criteria:

1. Age 2 years～18 years old
2. Children under anesthesia for elective colonoscopy with bowel preparation

Exclusion Criteria:

1. Children who are unable to perform bowel preparation with polyethylene glycol-4000
2. Children whose guardians refuse to participate in this study
3. Children who are unable to eat orally
4. Children with stomy
Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Age at entry 18-65 years;
* Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
* Liver biopsy demonstrating cirrhosis

Exclusion Criteria:

* Any other cause for liver disease other than chronic hepatitis C;
* History or presence of complications of cirrhosis;
* Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
* Diseases or conditions that could interfere with participation in the study
Non-invasive Spinal Cord Stimulation After Spinal Cord Injury

Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.

This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.

This project will evaluate the effects of non-invasive lumbar ts-ES on locomotor function in people with incomplete motor SCI (iSCI) who retain some ability to stand or walk.

This study has 3 phases:

Baseline assessment - 2 sessions - week 1 -Lab visits #1-2

Locomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - Lab visits #3-14 (1hr, x3/week)

End of training assessment - 2 sessions - week 6- Lab visits #15-16.

Specific locomotor deficits of each participant will be evaluated, and their step-cycle-based peripheral muscle or nerve stimulation strategy will be determined accordingly to improve stance or step capacity. After augmenting their locomotor function with muscle or peripheral nerve stimulation-induced activation strategies that address particular and unique motor deficits, they will receive intermittent bouts of stance or locomotor training supplemented with ts-ES. The locomotor training will consist of standing/walking on a treadmill with appropriate bodyweight support and added muscle or peripheral nerve stimulation.

Specifically, the project aims to assess the following:

1. Does combined muscle (NMES) or peripheral nerve (PN) stimulation with ts-ES during treadmill stepping facilitate locomotor performance?
2. Does four weeks of combined training as described above (1hrx3/week) facilitate exercise capacity (measured by submaximal VO2) in persons with chronic iSCI?

Eligibility Criteria:
Inclusion Criteria:

* Has spinal cord injury, 6 mo or longer since injury
* Is between 20 and 65 years of age
* Has difficulty with trunk and/or lower limb function
* Stable medical condition
* Non-progressive etiology of spinal injury
* No ventilatory support

Exclusion Criteria:

* Genetic or degenerative etiology of spinal injury
* Need for ventilatory or other life-sustaining medical support
* History of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.)
Evaluate the Effects of Patupilone on the Pharmacokinetics of Midazolam and Omeprazole in Patients With Advanced Malignancies (Extension)

The purpose of this extension study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.


Eligibility Criteria:
Inclusion criteria:

* Male or female patients 18 years or older
* Histologically documented advanced solid tumor, who have failed standard systemic therapy, or for whom standard systemic therapy does not exist
* Completed the Core study
* Completed all sampling in the core and not dose reduced Patients with adequate hematologic parameters

Exclusion criteria:

* Female patients who are pregnant or breast-feeding.
* Patients with a severe and/or uncontrolled medical disease
* Patients with a known diagnosis of human immunodeficiency virus (HIV) infection
* Patients having received an investigational agent within 30 days prior to study entry

Other protocol-defined inclusion/exclusion criteria may apply