Kornimate/medical-research-clean huggingface dataset:
etanercept and rituximab in patients with chronic lymphocytic leukemia and small lymphocytic lymphoma

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this is a phase i/ii study of the combination of etanercept and rituximab in patients with chronic lymphocytic leukemia (cll) and small lymphocytic lymphoma (sll). this combination is proposed to improve the efficacy and diminish the toxicity of this the

rationale: previous research has demonstrated that rituximab has efficacy against chronic lymphocytic leukemia (cll) and small lymphocytic lymphoma (sll). rituximab is a monoclonal antibody used to treat different types of lymphomas. monoclonal antibodies are a type of immunotherapy used against some types of cancer. they are produced in a laboratory and designed to target as well as bind with cells that carry specific proteins. rituximab attaches to a protein called cd20 that is found almost exclusively on the surface of b-cells. once rituximab attaches to the protein, the immune system activates to kill the malignant b-cells. researchers are investigating what other therapies to combine with rituximab to reduce side effects and improve patient outcomes. the current study combines etanercept with rituximab. etanercept is an anti-inflammatory agent being tested as a therapy for cancer. researchers want to assess the theory that etanercept may reduce the toxicity associated with rituximab in patients and increase efficacy while providing its own treatment benefit to patients. purpose: this study is evaluating the safety and efficacy of combination etanercept and rituximab in patients with cll and sll. the biological response of tumor cells and the immune system to this drug combination will also be measured in patients before, during, and after therapy administration. treatment: patients in this study will receive etanercept and rituximab. etanercept is given through injections into the skin and rituximab through intravenous infusions. during the first week of the study, etanercept alone will be given to patients two times. during the second week, patients will continue receiving etanercept twice weekly and begin receiving rituximab three times weekly. this schedule of etanercept twice weekly and rituximab three times weekly will be repeated four times. several tests and exams will be given throughout the study to closely monitor patients. treatments will be discontinued due to disease growth or unacceptable side effects.

Eligibility criteria:
inclusion criteria: * must have been previously treated cll/sll * must have cd20 expression * ecog ps =\<3 * no prior campath-1h * no active infection requiring antibiotics * no concurrent immunosuppressive therapy * no prior history demyelinating neurologic disease * no active viral hepatitis exclusion criteria: * no pregnant or breastfeeding women * ecog ps =4 * life expectancy of \>12 weeks * patients with bilirubin or creatinine\>3.0 mg/dl

Keywords: leukemia lymphoma
study to evaluate patients with cerebrotendinous xanthomatosis (restore)

Conditions: CTX

Summary: the study is made up of two cohorts: a randomized double-blind crossover (placebo withdrawal with rescue) study among patients ≥ 16 years of age (adult cohort) and an open-label dose titration study among pediatric patients ≥1 month and \<16 years of age (pediatric cohort)


Eligibility criteria:
inclusion criteria: 1. male or female at least 1 month or older at screening. 2. clinical diagnosis of ctx with biochemical confirmation. 3. women of childbearing potential must agree to the use of one highly reliable method of contraception during the study, plus one additional barrier method during sexual activity. 4. males must be surgically sterile, or males and their sexual partners must together agree to use medically accepted methods of contraception that are considered highly reliable during the course of the study. exclusion criteria: 1. genetic testing does not confirm ctx. 2. malabsorption disorder or confounding inflammatory gastrointestinal condition (for example, irritable bowel syndrome). 3. documented history of heart failure. 4. treated with medications which impact bile acid absorption such as bile acid sequestering agents (eg, cholestyramine, colestipol, aluminum-based antacids. 5. treated with cholic acid medication. 6. female patient who is pregnant, plans to become pregnant during the course of the study, or is breastfeeding. 7. positive at screening for the human immunodeficiency virus (hiv) or markers indicating acute or chronic hepatitis b infection or hepatitis c infection.

Keywords: cerebrotendinous xanthomatosis ctx cholestanol leukodystrophy cyp27a1
estradiol effects on alcohol across the menstrual cycle

Conditions: Alcohol Use, Unspecified

Summary: this study will provide the first rigorous integrative test of the hypothesis that rapid rises in estradiol (a female hormone) increase the rewarding and disinhibiting effects of alcohol and that such increased sensitivity correlates with increased alcohol use. identification of the behavioral mechanisms by which estradiol surges can increase alcohol use would provide a critical advancement of neurobiological theory of alcohol abuse in women, an understudied area, as well as provide new directions for personalization of alcohol abuse treatment in women. in this study, naturally-cycling women will be examined daily over their menstrual cycle using an integrative combination of daily ecological assessments of hormone fluctuations and alcohol use along with strategically-timed laboratory tests of their acute sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol.


Eligibility criteria:
inclusion criteria: * female * regular menstrual cycle * consume alcohol at least once per week * no history of drug or alcohol dependence exclusion criteria: * use of hormone-based medications * irregular menstrual cycle * current pregnancy * primary sensorimotor handicap * frank neurological disorder * pervasive developmental disorder * frank psychosis * diagnosed intellectual disability * medical condition contraindicating alcohol use * substance abuse history (except nicotine) * body mass index (bmi) 30 or above * alcohol abstainer

Keywords: estradiol reward menstrual hormone
prognostic value serum concentration of indoxyl sulfate during acute kidney injury in septic shock patients.

Conditions: Acute Kidney Injury; Septic Shock; Uremic; Toxemia; Mortality

Summary: the development of acute kidney injury (aki) during septic shock is frequent and is associated with a high mortality rate. the reason of this increased mortality despite the use of renal replacement therapy is still unknown. the deleterious effects of uremic toxins (solutes accumulating with the loss of kidney function) has risen for the last decade in chronic kidney disease patients. among those solutes, indoxyl sulfate (is) is associated with the development of cardiovascular complications and impairment of immune response. the role of uremic toxins and particularly is in the prognostic of septic kidney injury is unknown. the investigators propose to analyze the relation between the serum concentration of is and the mortality of patients hospitalized for a septic shock who developed an aki.

during chronic kidney disease the uremic toxins have been widely described as potential harmful solutes targeting the cardiovascular system, immunologic system, endothelium and bone metabolism. however, nothing is known about the potential accumulation and pejorative effects of those uremic toxins during aki (acute kidney injury). the objective of this study is to explore the role of the uremic toxins and specially is (indoxyl sulfate) in the mortality of patients hospitalized for a septic shock and aki. this study will also describe for the first time the kinetic of the blood concentration of different uremic toxins and their relation with the mortality and the kidney function.

Eligibility criteria:
inclusion criteria: * patients over 18 years hospitalized in the medical intensive care unit in amiens university hospital * presence of a septic shock (sepsis associated with a persistent hypotension after fluid resuscitation and requiring vasopressors to maintain map \> 65 mmhg and/or serum lactate level \> 2 mmol/ l). * evidence of aki (kdigo \> or equal1) in the 72 hours following the admission in the icu: diuresis \ or equal 1.5 to1.9 fold increase or \> 26.5 micromol / l in serum creatinine from baseline * signed written informed consent form * covered by national health insurance exclusion criteria: * known pre hospitalization (in the last 3 month preceding the hospitalization) advanced chronic kidney disease defined by an estimated glomerular filtration rate \< 60 ml / min / 1.73m square * pregnancy * presence or strong clinical suspicion of renal obstruction * moribund patients (expected life \< 48h) * cardio respiratory arrest * hemoglobin level below 10 g / dl

Keywords: acute kidney injury septic shock uremic toxins indoxyl sulfate mortality
lung screening study

Conditions: Lung Cancer

Summary: rationale: new imaging procedures such as spiral ct may improve the ability to detect lung cancer in patients who are at high risk for the disease. purpose: randomized clinical trial to compare the effectiveness of a spiral ct scan with that of a chest x-ray in detecting lung cancer in patients who are at high risk for the disease.

objectives: i. compare the efficacy of screening spiral ct scan and screening chest x-ray in detecting lung cancer in current or former smokers at high risk for lung cancer. outline: this is a randomized, multicenter study of lung cancer screening. patients are randomized to one of two screening arms. arm i: patients undergo one spiral ct scan. arm ii: patients undergo one chest x-ray. patients and their primary care physicians are notified of test results within 3 weeks of the exam. projected accrual: a total of 3,000 participants (1,500 per screening arm) will be accrued for this study at six screening centers (500 per center) by october 31, 2000.

Eligibility criteria:
disease characteristics: see general eligibility criteria patient characteristics: age: 55 to 74 patients with a cigarette smoking history of at least 30 pack-years current smoker or smoker who has quit smoking within the past 10 years no known prior history of lung cancer prior concurrent therapy: no concurrent therapy for any cancer except nonmelanomatous skin cancer no prior removal of any portion of the lungs no concurrent participation in other cancer screening trial, including plco no concurrent participation in a primary cancer prevention trial other than a smoking cessation trial

Keywords: non-small cell lung cancer small cell lung cancer
positive airway pressure therapy study in sleep apnea and diastolic heart failure

Conditions: Diastolic Heart Failure

Summary: this is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants with diastolic heart failure will be assigned to ventilation therapy (autoset cs ™ asv device; therapy group). the trial will run for 6 months, after which change in echocardiographic parameters of diastolic left ventricular function, sleep and quality of life parameters will be evaluated.


Eligibility criteria:
inclusion criteria: * clinical signs and symptoms of heart failure according to the esc guidelines * echocardiographic evidence of a preserved systolic left ventricular function (echocardiographic left ventricular ejection fraction \> 50%) * polysomnographic evidence of at least moderate sleep-disordered breathing: apnea-hypopnea index (ahi) \> 15 / h with ≥ 50% central events and with with a central ahi of ≥ 10/h (ahi based on total sleeping time, tst) * bnp or nt-pro bnp ≥ 300 pg / ml * nyha class ii or iii * patient tolerates the ventilation treatment (1h sample ventilation) * stable drug therapy in the last 4 weeks prior to randomization (no iv diuretic therapy or increasing the dose of diuretics to ≥ 100%) * minimum age of patients of 18 years * patient willing to undergo study procedures * signed informed consent exclusion criteria: * oxygen saturation (so2) \<92% of the days in peace without o2 therapy, measured baseline (start time) in the pulse oximetry or polysomnography in a cape. bga (the measurement must be max. lie back 1 week) * patients, who have a risk professional with symptomatic sleep apnea * known copd with fev1 \<70% * patients with nyha stadium iv * advanced congenital heart defects * pericardial diseases * existing pap or bi-level therapy (including adaptive servo-ventilation) in the last 3 months * acute cardiac event in the last 3 months * bmi ≥ 35kg / m² * pregnant or lactating women

Keywords: diastolic heart failure
efficacy and safety of tolperisone in subjects with pain due to acute back muscle spasm

Conditions: Back Muscle Spasm; Back Pain; Back Strain; Back Spasm Upper; Muscle Spasm; Acute Pain

Summary: this is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.


Eligibility criteria:
inclusion criteria: * ambulatory * current acute back pain due to acute muscle spasm starting within 7 days prior to study entry (day 1) and at least 8 weeks following resolution of the last episode of acute back pain. * willingness to discontinue all previous or ongoing treatment of pain or muscle spasm on study entry at day 1 through the end of treatment including medication, acupuncture, chiropractic adjustment, massage, transcutaneous electrical nerve stimulation \[tens\], or physiotherapy. * pain must be localized from the neck (c-3 or lower) to the inferior gluteal folds and spasm assessed during the screening physical examination. * body mass index range between 18 and 35 kg/m², inclusive. exclusion criteria: * presence of acute or chronic back pain for the previous 8 days or longer, where back pain is present on more days than not. * presence of neurogenic pain in the back, neck, upper or lower extremities, including pain from (or suspected from) nerve root compression or injury (radicular pain or "pinched nerve") or neuropathic pain. evidence of these types of exclusionary pain includes radiation of pain that radiates beyond the back, chronic pain, and pain associated with abnormal sensation or loss of sensation in the back or extremities. * presence of pain anywhere other than the target back pain that is bothersome, interferes with activity, or for which pain relief is taken. * history of any neck, back, or pelvic surgery. * history within the previous 3 years of: spinal fracture or spinal infection; inflammatory arthritis; degenerative spine disease; or any other back or spine condition that may reasonably contribute to current back pain. * subjects who test positive for alcohol by breathalyzer test or have a positive urine drug screen for drugs of abuse (e.g. amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, cannabinoids, oxycodone, opiates), including cannabis even where legal, at screening.
long term cardiovascular complications in men with obstructive sleep apnea

Conditions: Obstructive Sleep Apnea; Cardiovascular Diseases; Metabolic Diseases

Summary: subjects with obstructive sleep apnea (osa) are at increased risk of developing cardiometabolic complications, and effective long-term ncpap treatment significantly reduces the risk of cardiovascular morbidity and mortality.

1. primary outcome: incidence of cardiometabolic diseases in subjects with osa over 9 years. 2. secondary outcomes: effects of cpap treatment on cardiometabolic conditions

Eligibility criteria:
inclusion criteria: * from previous cohort for reassessment. exclusion criteria: * unstable medical conditions

Keywords: obstructive sleep apnea cardiometabolic complications effects of cpap treatment
the united kingdom facioscapulohumeral muscular dystrophy patient registry

Conditions: Facioscapulohumeral Muscular Dystrophy

Summary: facioscapulohumeral dystrophy (fshd) is the third most common form of neuromuscular dystrophy worldwide with an estimated prevalence of one in 20,000. fshd is an autosomal dominant genetic disease and is estimated to affect up to 3,000 people in the uk. the patient registry facilitates a questionnaire based research study to better characterise and understand the disease in the uk, and helps to identify potential participants eligible for clinical trials.

the uk fshd patient registry (https://www.fshd-registry.org/uk/) recruits any individual, from anywhere within the united kingdom, with a diagnosis of fshd. the registry is sponsored by muscular dystrophy uk. participants may be referred to the registry by health care professionals, genetic testing/laboratory centres who are aware of the registry etc. alternatively, a participant may have discovered the registry via promotional activities or by their own online searches. after completing the consent process, participants are able to enter information on to the registry platform (note all forms are available to view on the registry website before joining the registry). this is an ongoing database and all participants are invited to update their information on an annual basis. the database is designed to be self reporting, however where specialised clinical or genetic information is required, the neuromuscular specialist in charge of the participants care can be invited to provide some additional information. the participant is able to select a health care provider from a pre-populated list at registration stage, if they wish to (optional feature). this information is included in the patient information and consent. relevant r\&d approval has been recieved.

Eligibility criteria:
inclusion criteria: - all patients with a confirmed fshd diagnosis (or pending diagnosis) who reside in the uk are eligible for inclusion. exclusion criteria: * any confirmed nmd other than fshd * living outside of the uk

Keywords: fshd facioscapulohumeral muscular dystrophy facioscapulohumeral muscular dystrophy type 1 facioscapulohumeral muscular dystrophy type 2 muscular dystrophy
phase ii randomized study of muromonab-cd3, cyclosporine, methylprednisolone, and prednisone in patients with giant cell myocarditis

Conditions: Myocarditis; Giant Cell Myocarditis

Summary: objectives: i. assess the effect of immunosuppression with muromonab-cd3, cyclosporine, methylprednisolone, and prednisone versus standard care in terms of death, heart transplantation, or left ventricular assistive device placement in patients with giant cell myocarditis. ii. compare left ventricular ejection fraction prior to and after 4 weeks of treatment in these arms. iii. compare the degree of myocardial inflammatory infiltrate prior to and after 4 weeks of treatment in these arms.

protocol outline: this is a randomized, open label, multicenter study. patients are randomized to receive standard care with immunosuppression (arm i) or standard care with or without immunosuppression (no muromonab-cd3 or cyclosporine)(arm ii). arm i: patients receive methylprednisolone iv once daily for 3 days and muromonab-cd3 iv once daily for 10 days. oral cyclosporine is administered twice daily and oral prednisone is administered once daily for 1 year. arm ii: patients receive standard care with or without immunosuppression (no muromonab-cd3 or cyclosporine). patients are followed for one year.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- idiopathic giant cell myocarditis confirmed by endomyocardial biopsy heart failure and/or arrhythmia of less than 3 months duration --patient characteristics-- hepatic: ast/alt no greater than 3 times upper limit of normal renal: creatinine no greater than 2.5 mg/dl other: not pregnant or nursing; negative pregnancy test; fertile patients must use effective contraception; no clinical evidence of sepsis or active infection (e.g. meningitis, osteomyelitis, etc.); no contraindication to immunosuppression; no allergy to cyclosporine or muromonab-cd3; no other severe concurrent diseases

Keywords: cardiovascular and respiratory diseases giant cell myocarditis rare disease
ascending multi-dose study of regn727(sar236553) with and without concomitant atorvastatin

Conditions: Hypercholesterolemia

Summary: this study will test the safety, tolerability, and bioeffects (how the body reacts to the drug) of regn727 compared with placebo (an inactive substance that contains no medicine) in hyperlipidemic patients with or without atorvastatin therapy. the study drug and placebo will be administered by subcutaneous injection at the clinic. there will be a total of 2 or 3 study drug injections over 16 clinic visits, which will include 3 overnight stays(study duration 148 days, not including the screening period). patients on atorvastatin will take their daily dose in the morning for the duration of the study. patients will be monitored by the study staff for side effects and the body's response to the study drug. vital signs(blood pressure, temperature, breathing and heart rate) will be checked, and blood and urine samples will be collected at some or all visits.


Eligibility criteria:
inclusion criteria * men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen * body mass index between 18.0 and 35.0 kg/m2, inclusive * for women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on day -2 or day -1 * for men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant)during the full duration of the study * willing, committed and able to return for all the clinic visits and complete all study-related procedures * able to read, and able to sign the informed consent form exclusion criteria: * history of mi, acs, angina, stroke, peripheral vascular disease, or cardiac revascularization * pregnant or breast-feeding women * blood donation of any volume within 1 month prior to administration of study drug * congestive heart failure * consumption of greater than 1 quart of grapefruit juice per day * previous exposure to any therapeutic or investigational biological agent within 30 days of screening * history of alcohol or drug abuse within one year to the screening visit the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.