cyrilzakka/clinical-trials huggingface dataset:
Flavopiridol in Treating Patients With Chronic Lymphocytic Leukemia

Phase II trial to study the effectiveness of flavopiridol in treating patients who have chronic lymphocytic leukemia that has not responded to treatment with fludarabine. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die

OBJECTIVES: Determine the complete and partial response rate to flavopiridol in patients with fludarabine-refractory chronic lymphocytic leukemia.

Assess the toxicity profile of this treatment in these patients. Examine progression-free survival and overall survival following this treatment in these patients.

Determine the effects of flavopiridol on normal T-cell subsets and immunoglobulin levels in these patients.

OUTLINE: This is an open label, multicenter study.

Patients registered before 9/15/2000 receive flavopiridol IV continuously on days 1-3. Treatment repeats every 14 days for a total of 12 courses in the absence of disease progression or unacceptable toxicity.

Patients registered after 9/15/2000 receive flavopiridol IV over 1 hour daily on days 1-3. Treatment repeats every 3 weeks for a total of 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for the first year and then every 6 months for 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed intermediate risk (stage I or II) or high risk (stage III or IV) refractory B-cell chronic lymphocytic leukemia
* Intermediate risk group must have evidence of active disease as shown by at least one of the following:

  * Massive or progressive splenomegaly and/or lymphadenopathy
  * Weight loss of greater than 10% in the last 6 months
  * CALGB grade 2-4 fatigue
  * Fevers greater than 100.5 degree Fahrenheit OR night sweats for greater than2 weeks without evidence of infection
  * Progressive lymphocytosis with an increase greater than 50% over a 2 month period or an anticipated doubling time of less than 6 months
* Refractory to fludarabine treatment OR relapsed within 6 months of fludarabine
* Lymphocytosis greater than 5000/mm3 at some time during disease
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 times ULN
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No more than 1 prior nonradiolabeled antibody treatment (e.g., Campath-1H or rituximab)
* At least 1, but no more than 3, prior chemotherapy regimens
* At least 1 prior chemotherapy regimen comprising fludarabine
* No other concurrent chemotherapy
* No concurrent chronic use of oral corticosteroids
* No concurrent hormone therapy except for non-disease related conditions
* No concurrent dexamethasone or other corticosteroid-based antiemetics
* No concurrent palliative radiotherapy
Volume-challenge in Morbid Obesity

Preoperative venous return stability and euvolemia is essential in management of morbidly obese patients. Fluid therapy regimes for patients with high BMI, especially with focus on preoperative management, are rare and not in consensus.The aim of this study was to evaluate preoperative effects of a standardized, ideal body weight (IBW) based volume-challenge on hemodynamics, stroke volume and level of venous return to the heart.

34 morbidly obese patients scheduled for bariatric surgery underwent a preoperative three-week preparation by rapid-weight-loss-diet (RWL) to be accepted for bariatric surgery. Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume-challenge (VC) based on 6ml colloids /kg IBW. Feasibility of standardized VC was evaluated by TTE. Dynamic and non-dynamic echocardiographic indices for VC were studied.

Main outcome measures: Volume-responsiveness and level of venous return before and after volume-challenge were assessed by TTE. An increase of stroke volume ≥ 13% was considered as a volume-responder.

Eligibility Criteria:
Inclusion Criteria:

* enrolled for bariatric surgery
* BMI ≥ 40 or ≥ 35kg/m2 with co-morbidities
* preoperative three-weeks preparation by rapid-weight-loss-diet and weight loss

Exclusion Criteria:

* untreated significant hypertension
* unstable angina pectoris
* significant valve regurgitation or stenosis
* known severe pulmonary disease
Cognitive Impairement In Frontotemporal Dementia

This is an observational study that aims to better understand the genetic causes of frontotemporal degeneration (FTD), Multiple Systems Atrophy (MSA), and Progressive Supranuclear Palsy (PSP). It is hoped the information gathered in this study will help lead to better diagnostics and future treatments.

Comparative and longitudinal studies reveal clinical differences between subgroups of patients with frontotemporal dementia (FTD), including Progressive Non-fluent Aphasia (PNFA), Semantic Dementia (SD), patients with a disorder of social comportment and personality (SOC), and non-aphasic patients with executive dysfunction (EXEC). MRI studies of cortical atrophy and fMRI studies show correlated neural defects in FTD subgroups. The investigators will obtain converging evidence from multiple sources to test hypotheses about the neural basis for cognitive functions such as semantic memory, grammatical processing, and social functioning in these FTD subgroups, while improving clinical care for these patients. Recent studies have linked progressive supra nuclear palsy (PSP) and multiple systems atrophy (MSA) to FTD. The investigators will obtain comparable neuropsychological and biomarker data in order to compare these patient groups.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who have been diagnosed with FTD, PSP, and MSA

Exclusion Criteria:

* Individuals under 18 years of age
* People with pacemakers or certain metallic implants
* pregnant women
Sympathetic Nerve Activity and an Implantable Cardioverter Defibrillator in Heart Failure Patients

The aim of this study is to analyze whether the sympathetic tone, measured indirectly and directly by muscle sympathetic nerve activity recording, is elevated in patients with heart failure receiving an appropriate shock from their implantable cardiac defibrillator (ICD) compared to heart failure patients not receiving a shock from their ICD. All parameters measured in this study will be used to build a risk algorithm able to identify heart failure patients at high risk for sudden cardiac death who could receive an ICD.

We plan to perform an extensive study of the sympathetic nervous system activity in heart failure patients with an ICD. The SNS activity will be measured directly by a recording of the muscle sympathetic nerve activity and indirectly by post processing of 24-hour Holter recording, catecholamine levels assessment, and spontaneous baroreflex sensitivity. A global assessment of the patients status will also be realised. Patients will be followed for one year. During follow up, this cohort will be divided into two groups according to the occurrence or not of an appropriate shock. We assume that an appropriate shock is a surrogate marker for sudden cardiac death. We plan to compare the autonomic nervous system activity in both groups of patients in order to identify a score able to detect heart failure patients at high risk for sudden cardiac death.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patient with an ICD

Exclusion Criteria:

* Pregnant patient
* Acute coronary syndrome within the last 3 months
* Peripheral neuropathy.
Association Between Low Cortisol Levels and Whiplash Syndrome

The investigators hypothesis is that low (or low relatively to the situation) cortisol levels might be a causative factor of whiplash injury or post traumatic stress disorder following road accidents. In this study the investigators enroll patients who sustained a road accident. From all patients a blood sample will be withdrawn to measure cortisol concentrations. Than, the patients will be divided into 2 groups: the study group will receive a single injection of intravenous Hydrocortisone 100 milligram (a synthetic steroid used routinely for many years). The control group will receive a same volume of normal saline which would be used as a placebo treatment. The investigators assume that patients with low cortisol levels would tend to have a higher incidence of whiplash injuries and / or post traumatic stress disorders, and that a single bolus of hydrocortisone may prevent these untoward sequelas of trauma.

Study protocol Patients arriving during day time (08:00 - 16:00) to the Soroka Hospital emergency department following a motor vehicle accident and will be found eligible will be asked to participate in the study. Following an informed consent the recruited patients will be randomly divided into a study group or a control group. From all the participants a volume of 5 milliliter of peripheral blood will be withdrawn for cortisol concentration determination prior to the study intervention. After withdrawing the blood sample patients will receive a single bolus of intravenous Hydrocortisone 100 milligram (study group) or normal saline (0.9%) at a similar volume to that of the study drug, 5 ml (control group). Patients will be otherwise receiving the regular management of a trauma patient. The enrolled patients will fill simple, short questionnaires including demographic data, neck disability index, (NDI), numeric pain rating scale (NPRS), Tampa scale for kinesiophobia (TSK-11), PTSD questionnaire (PDA), and will be assessed by the treating physician for the degree of whiplash (WAD 0-4).

The patients will be followed-up by one of the investigators for a period of 6 months. In each visit the patient will be assessed again by the above mention tools.

Sample size: 45 patients in each arm. Blinding and randomization: triple blinding and using a randomization software. Statistical assessment will be performed to identify differences of developing WAD (whiplash associated disorder) between patients who had an admission low level of cortisol compared with those who had a high or normal level, and also between patients who received hydrocortisone compared to those who received placebo.

Eligibility Criteria:
Inclusion Criteria:

* victims of motor vehicle accidents
* signed informed consent

Exclusion Criteria:

* pregnancy
* traumatic brain injury
* psychiatry disorders
* active cancerous conditions
* adrenal diseases
* medical treatment by estrogens, anti-depressants, melatonin, pain control.
* substance abuse
* hospitalization due to the trauma
* contra indication to hydrocortisone treatment
* over 6 hours from time of injury
Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease

The PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study. It is a pilot registry study towards a subsequent large pivotal phase registry. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON™ Atherectomy System, within the initial launch phase of the product in the market.

US multicenter, prospective, single-arm, observational post market Registry. A pilot registry towards a subsequent large pivotal registry (PATHFINDER II), aimed to evaluate the safety and efficacy of Auryon™ Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years old.
2. Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease.
3. Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ).
4. Subject is capable and willing to comply with the scheduled follow up
5. Subject is able and willing to sign a written Informed Consent Form (ICF).

Exclusion Criteria:

1. Target lesion is in an arterial bypass.
2. Planned use of another atherectomy device in the same procedure
3. Co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study.
4. Participating in another study on an interventional non-cleared device, that could impact the study results
Nutritional Prevention of Exertional Muscle Dysfunction

The investigators want to find out whether a choline supplement can protect muscle health in young men with very common genetic vulnerabilities. Men, who respond to a brief, but intense set of arm exercise and have a common genetic profile, will be asked to use a choline supplement for three weeks and a placebo for three weeks. Before the begin of the supplementation study and after 3 and 6 weeks the investigators will test response to the exercise challenge and ask that all consumed foods are recorded.

An initial screening questionnaire will determine general eligibility. The investigators will screen white young males with low to moderate choline intake (\<450 mg/d) for CK response to exercise (high/low) by having them do intense eccentric exercise (12 elbow flexor contractions of non-dominant arm with dumbbell at 100% maximal lift capacity) and then 72 hours (3 days) later draw 250 μl capillary blood by finger stick for CK, metabolomic and genetic measurements.

The investigators plan to recruit 30 CK responders with an 1958 A allele of the methylenetetrahydrofolate dehydrogenase 1 (MTHFD1), which is present in about 60% of Caucasian males.

All participants will be asked to complete on three days 24-hour diet interviews with an online automated program provided by the National Cancer Institute. Participants of the intervention study will also have to be complete interviews on the final three days of the two intervention periods The recruited candidates will do an initial exercise challenge with no intervention, then a second challenge after three weeks with the first supplement (randomized choline or placebo), then a third challenge after another three weeks with the complementary second supplement (choline if they had placebo first, placebo if they had choline first).

Samples identified only by code will be stored indefinitely at the UNC Nutrition Research Institute to permit the analysis of additional genetic markers related to muscle health and choline metabolism when the capacity for the analysis of such markers becomes available. Such analyses may be carried out at the University of North Carolina Nutrition Research Institute (UNC NRI) or at external laboratories providing the service for the PI. Samples will be destroyed once no such additional analyses are intended or feasible anymore or if the investigators do not continue this research. Storage of the samples is not optional.

Eligibility Criteria:
Inclusion Criteria:

* Caucasian
* choline intake less than 450 mg
* exertional muscle dysfunction
* susceptible genetic profile

Exclusion Criteria:

* severe chronic illness
* limited range of arm motion
* required use of prescription medication
* required use of dietary supplements
Effects of Imatinib in Subjects With Seasonal Allergic Rhinitis and Who Are Sensitive to Timothy Grass Pollen

This study will assess the effects of Imatinib on allergic inflammation following repeated nasal allergen challenge in subjects with seasonal allergic rhinitis sensitive to Timothy grass pollen.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male non-smoking subjects aged 18-55 years, with a history of seasonal allergic rhinitis consistent with Timothy grass pollen allergy. They must show: a positive skin prick test to Timothy grass pollen (wheal difference Timothy grass pollen - negative control ≥ 3 mm) at or within the 12 months preceding the screening visit and demonstrate symptomatic worsening (TNSS ≥4) within one hour after nasal allergen challenge
* Be otherwise healthy with no health problems that may jeopardize the subjects participating in the study, absence of history of other significant allergies.
* Subjects and their partners must agree to use effective contraceptive measures from screening until the end of study visit.

Exclusion Criteria:

* Respiratory disease other than a history of mild stable asthma not requiring treatment and associated with normal lung function.
* Structural nasal abnormalities or nasal polyps on examination, a history of frequent nose bleeding, recent nasal surgery or recent (within 8 weeks prior to baseline visit) or recent (four weeks) or ongoing upper or lower respiratory tract infection.
* Use of any medication that would affect the response to the allergen challenge (e.g. corticosteroids, decongestants, anti-histamines, medications with anti-inflammatory effects) or any other nasally applied medication within 14 days prior to allergen challenge (30 days for systemic anti-inflammatory therapy including oral corticosteroids), or known to influence Imatinib bioavailability or clearance
* History or laboratory evidence of acute or chronic renal insufficiency or abnormal liver function.
* Subjects may voluntarily withdraw from or be withdrawn from the study at the discretion of the investigator or the sponsor at any time. Subjects may be withdrawn from the study prematurely for one of the following reasons:
* Subject withdrew consent
* Upper respiratory tract infection
* Presence of allergic rhinitis symptoms in the screening period or prior to pre-wash on Day 1
* A past medical history of inherited heart disease, valve defect, cardiomyopathy, rheumatic fever, arrhythmias, cardiac interventions or clinically significant ECG abnormalities.
* Adverse events and non-tolerable symptoms resulting from allergen challenge
* Administration of a concomitant medication (other than those randomized to receive Fluticasone propionate) that would impact on the study results (e.g. corticosteroids), including any subjects requiring asthma therapy (inhaled or systemic).

Other protocol-defined inclusion/exclusion criteria may apply
Early Versus Late Laparoscopic Exploration of Common Bile Duct After Failure of Extraction of Common Bile Duct Stones by ERCP

The goal of this work is to assess the best time to perform LC combined with LCBD exploration and the feasibility and safety of such procedure in patients with combined GBS and CBDS after failure of ERCP extraction of CBD stones .


Eligibility Criteria:
Inclusion Criteria:

1. All patients that presented with calcular obstructive jaundice 2ry to CBD stones.
2. Failed of extraction of common bile duct stone by ERCP.

Exclusion Criteria:

1. patients presented by cholangitis.
2. patients presented by acute pancreatitis.
3. Patients that developed post ERCP pancreatitis ,bleeding , perforation.
4. history of previous biliary surgery rather than cholecystectomy.
5. history of major upper abdominal surgery.
6. pregnant females.
7. patients with liverchirosis, abdominal malignancy , and those unfit for surgery.
Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency

The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. The second aim was to compare the long-term renal protection between benazepril and losartan at similar clinical setting.


Eligibility Criteria:
Inclusion Criteria:

1. Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
2. Creatinine clearance of 20 to 70 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
3. nondiabetic renal disease
4. Persistent heavier proteinuria (defined by urinary protein excretion of more than 1.0 g per day for three or more months without evidence of urinary tract infection or overt heart failure \[a New York Heart Association class of Ⅲ or Ⅳ\])

Exclusion Criteria:

1. Immediate need for dialysis
2. Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs
3. Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
4. Renovascular disease
5. Myocardial infarction or cerebrovascular accident in the year preceding the trial
6. Connective-tissue disease; and obstructive uropathy
Effectiveness of a Robot Assisted Tenodeis-grip Neurorehabilitation

In the proposed study, the investigators assumed that using robot assisted tenodesis-grip training providing high does assisted grip movement may do the effects on motor shaping and greater brain priming for hand paresis of the stroke patients. The specific aim of this study is to examine the difference in the treatment effects between the combination of robot assisted tenodesis-grip training with task-oriented training and combination of traditional occupational therapy with task-oriented training on the motor, sensation, hand performance of the stroke patients. The expected outcomes of this research are to help the clinicians understand the training mechanism and effects of robot assisted tenodesis-grip training on functional performance of upper extremity for unilateral stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of stroke with unilateral side involved;
2. Stroke at least 7 days before the start of the first assessment session;
3. A score of Mini-mental state examination greater than 24 for proving higher mental function;
4. Premorbid right-handedness.

Exclusion Criteria:

1. Uncontrolled hypertension;
2. Major cognitive-perceptual deficit;
3. Other brain disease.