Kornimate/medical-research-clean huggingface dataset:
blood cell response to exercise

Conditions: Metabolic Syndrome

Summary: moderate exercise is recommended to improve cardiovascular health in obese and overweight people particularly with metabolic syndrome (mets) that have hypertension, elevated fasting blood sugar, and elevated blood lipids. this study is being done to determine how platelets respond when a person performs an initial period of moderate exercise.


Eligibility criteria:
inclusion criteria: * 30-60 years old * bmi \>/=26 and \<40 kg/m2 * not planning to or currently attempting to gain or lose weight * low reported omega-3 fatty acid intake per omega-3 checklist * metabolic syndrome as define 3/5 of the following:waist circumference: men \> 102 cm women \> 88 cm, triglycerides \> 150 mg/dl, hdl cholesterol: men \ 130/\>85 mmhg,fasting glucose \> 100 mg/dl (hypertensive subjects are eligible if taking thiazide diuretics not ace inhibitors beta blockers) exclusion criteria: * smoke or use tobacco or nicotine in any form (including pills and patches) * take any medication that makes you unable to exercise * have established cardiovascular, pulmonary, and/or metabolic disease such as diabetes * have uncontrolled hypertension * have alcohol, anabolic steroid, or other substance abuse issues * consume more than 3 alcoholic drinks/week * have joint or muscle injuries that affects your ability to exercise * have cancer (other than skin cancer or carcinoma in situ of the cervix * pregnant or lactating * currently exercise regularly * taking non-steroidal anti-inflammatory medications (aspirin, aleve, advil, ibuprofen, naproxen * take lipid modifying medications such as statins (lipitor, zocor) * take medications for blood glucose such as insulin or metformin * take medications that affect platelet functions (plavix) * taking omega-3 supplements (fish or flax oil)

Keywords: metabolic syndrome obese overweight hypertension hyperlipidemia glucose intolerant high blood sugar exercise in obesity platelets
cardiorespiratory performance and pulmonary microbiome in patients after repair of esophageal atresia

Conditions: Esophageal Atresia

Summary: the majority of the clinical research on esophageal atresia focuses on the upper gastrointestinal tract. however, the trachea and the lung are also affected in many of these children, so that a lifelong pulmonary impairment may result. the importance of respiratory function in the context of follow-up of these patients has therefore been increasingly recognized in recent years. scientific work has shown significantly, that patients following esophageal atresia repair develop respiratory symptoms more frequently than the normal population. mild impairment of the pulmonary function in adolescence and adulthood was demonstrated in some studies, but to date, there is no exact idea about the relationship between early childhood disease progression and later pulmonary impairment. only a few scientific papers have dealt with the effect of impaired pulmonary function on the physical capacity of these adolescents and adults. most of these studies show small case numbers, inconclusive stress tests, and divergent results. the aim of this prospective study is to investigate the cardiopulmonary performance capacity and the pulmonary microbiome of adolescent and adult patients with corrected esophageal atresia and to compare the results with a control group. another focus of the investigators is on the composition of the pulmonary microbiome of the participants. changes of the pulmonary microbiome and the influence on the cardio-pulmonary performance capacity have not yet been investigated. furthermore, it should be investigated whether the treatment measures and a complicated disease course in the neonatal period have long-term effects on lung function, exercise capacity and composition of the microbiome in the lungs.


Eligibility criteria:
inclusion criteria: * age from 12 years * status post surgical correction of esophageal atresia with and without fistula * granted consent exclusion criteria: * acute infections within the last 14 days * other associated serious malformations * acute, temporary respiratory complaints (cough, allergies etc.) * physical and mental illnesses or disabilities that do not allow the examination to be carried out * non-granted consent
observational study to observe the efficacy of levemir® (insulin detemir) in patients with type 2 diabetes.

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this observational study is to observe the efficacy of levemir® treatment in patients with type 2 diabetes in everyday clinical practice in switzerland. furthermore the time period between diagnosis of type 2 diabetes and insulin initiation is evaluated.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus * insulin-naive or currently treated with another basal insulin * inclusion of patients at the discretion of the treating physician after the decision to prescribe levemir® exclusion criteria: * type 1 diabetes mellitus * patients treated with short acting or with premix insulin * women who are pregnant, breast feeding or have the intention to become pregnant * known or suspected allergy to the study product or related product * any exclusion criteria according to the swiss levemir® spc (summary of product characteristics)
intravenous autologous bone marrow-derived stem cells therapy for patients with acute ischemic stroke

Conditions: Acute Stroke

Summary: a multi-centric initiative to study safety,feasibility and efficacy of using intravenous autologous bone marrow mononuclear cells(bmmc) in patients with acute ischemic stroke.this phase of study is visualised as phase 2 study and will aim to determine dose response gradient of stem cell therapy and to explore if there is favorable risk to benefit ratio for autologous stem cell therapy in patient with acute ischamic stroke.

this phase of the study will have two arms developed through random allocation: one arm for intravenous autologous bone marrow derived stem cell/mononuclear cells(bmmc arm); and second control arm. patients with acute ischaemic stroke between 7-30 days after onset with moderae severity in sable condition will be entered into the study after informed consent. both arms will receive standard treatment but bmmc arm will,in addition,have bone marrow aspiration and receive autologous 30-500 million bone marrow mononuclear cells intravenously on the day of randomisation and all patients will be followed at day 7 ± days, day 90(-7 days to +14 days), day 180(-7 days to +28 days)and day 365 (-7 days to + 28 days). a number of safety and efficacy variables will be measured. this phase 2 study will aim to determine dose response gradient of stem cell therapy and to explore if results have a favourable risk to benefit ratio to justify a phase 3 study. this will be the first human trial to determine and compare favourable and unfavourable effects of bone marrow mononuclear cells(mainly cd34) in acute ischamic stroke and also the first multi-centric study with potential to achieve a reasonable sample size in a relatively short time.

Eligibility criteria:
inclusion criteria: 1. sudden onset of focal neurologic deficit or impairment of consciousness. 2. ct or mri scan of head showing no haematoma and relevant lesions within the mca and aca territory. 3. age between 30 -70 years (after amendment 18 -70 years). 4. \>7 to \</=30 days passed since the onset of the qualifying event. 5. glasgow coma scale score of \>8 at the time of randomization, in aphasic eye and motor score of \>6. 6. modified barthel index score of 50 or less at the time of randomization. 7. nhiss score of 7 or more points and inability to walk unaided or raise upper limb by 90 degree. 8. patient is stable. ( normal respiration, afebrile, bp less than mean arterial pressure of 125 mm of hg, fasting blood sugar \< 200 mg% and normal urea/electrolytes for at least 48 hours.) exclusion criteria: - 1. lacunar syndrome 2. intubation 3. posterior circulation stroke 4. co morbidity likely to limit survival to less than 3 years eg. hepatic or renal failure. 5. inaccessibility for follow up. 6. allergy to local anaesthetic. 7. unwillingness to provide written informed consent. 8. symptom of acute myocardial infarction or acute involvement of any other organ. 9. pregnancy 10. hiv positive 11. patient is a part of any other trial in last 6 months.

Keywords: acute ischemic stroke
nitrocamptothecin in treating patients with locally recurrent or metastatic breast cancer

Conditions: Breast Cancer

Summary: 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 nitrocamptothecin in treating patients who have locally recurrent or metastatic breast cancer.

objectives: i. assess the toxicity and efficacy of nitrocamptothecin in patients with locally recurrent or metastatic breast cancer. ii. determine the duration of response and time to treatment failure in these patients with this treatment regimen. iii. correlate serum levels of nitrocamptothecin and its lactone metabolite with response and toxicity in these patients. iv. correlate topoisomerase i and ii levels with toxicity and response in these patients. outline: patients receive oral nitrocamptothecin daily on days 1-5. treatment continues weekly for 8 weeks. patients achieving complete or partial response or stable disease continue therapy in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 18-43 patients will be accrued for this study within 8-18 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed locally recurrent or metastatic breast cancer not amenable to surgery or radiotherapy measurable or evaluable disease no prior radiotherapy to only target lesion disease progression after no more than 2 prior chemotherapy treatments for metastatic disease no active cns metastasis prior cns metastasis allowed with no evidence of active disease hormone receptor status: not specified patient characteristics: age: not specified menopausal status: not specified performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: absolute granulocyte count greater than 1,500/mm3 hemoglobin greater than 9.0 g/dl platelet count greater than 100,000/mm3 hepatic: bilirubin no greater than 2.0 mg/dl ast/alt no greater than 3 times upper limit of normal (uln) (no greater than 5 times uln in case of liver metastases) renal: creatinine no greater than 2.0 mg/dl other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception must be able to have daily fluid intake of at least 3 liters no concurrent active infection no other prior malignancy in past 5 years except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics no prior irinotecan, topotecan, or other camptothecin analogues at least 3 weeks since prior chemotherapy endocrine therapy: no concurrent corticosteroids to control cns disease radiotherapy: see disease characteristics at least 2 weeks since prior radiotherapy surgery: at least 4 weeks since prior major surgery

Keywords: stage iv breast cancer recurrent breast cancer
a multi-center randomized controlled trial of mentoring to prevent youth violence

Conditions: Violence

Summary: the purpose of this study is to test whether a violence prevention curriculum delivered by big brothers and big sisters staff and mentors can reduce violence involvement for assault-injured youth.

violent injury is a major cause of morbidity and mortality among adolescents. the presence of a positive adult role model is a well-established protective factor against violence and other maladaptive outcomes among youth. big brothers big sisters (bbbs) is the largest u.s. mentoring organization with proven effectiveness in improving youth outcomes. however, these programs may be less effective with youth who already are exhibiting involvement in problem behavior at the time of program referral. take charge!, a mentor- and professional-implemented intervention with 10-15 year old assault-injured youth, showed promise for improving perceived self efficacy for avoiding violence and for decreasing aggression and problem behavior. the overall goal of the proposed project is to develop, implement, and evaluate a research-informed youth development program that adapts the bbbs model to work for assault-injured youth. the aims are: * to expand and refine take charge! and integrate it with bbbs practices; * to conduct a randomized, controlled trial in which assault-injured 10-15 year old youth recruited from emergency departments in baltimore and d.c. receive either standard emergency department follow-up care or the take charge! 2 intervention with assessment of violence-related, mental health, and educational outcomes; * to conduct a comprehensive process evaluation of take charge! 2; * and to accurately measure the costs of the intervention and assess cost-effectiveness. youth violence is a major cause of morbidity and mortality with marked disparities by race/ethnicity and socioeconomic status. this study is a critical next step in translating evidence-based research to real-world settings and practice.

Eligibility criteria:
inclusion criteria: * treatment for an assault injury in the emergency room * english speaking (parent and youth) exclusion criteria: * treatment for child abuse, sexual abuse, sibling fights, or police fights * severe psychopathology

Keywords: youth violence assault-injured mentoring emergency room urban
outcomes of early referral to radiofrequency ablation in symptomatic atrial fibrillation patients.

Conditions: Atrial Fibrillation; Radiofrequency Ablation

Summary: atrial fibrillation (af) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality. the east-afnet 4 trial showed that rhythm control treatment (antiarrhythmic drugs aad or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation. in phase ii/iii gloria af registry, early af ablation within 3 months from initial diagnosis in a contemporary cohort of patients who were predominantly treated with non-vitamin k antagonist oral anticoagulants was associated with a survival advantage compared to medical therapy alone. moreover, early af ablation appeared to provide the greatest benefit compared to other treatments. the attest trial was a multicenter, randomized, prospective study in patients with paroxysmal atrial fibrillation (af) designed to assess whether radiofrequency (rf) ablation is more effective in delaying the progression to persistent af than aads. patients \>_65 years were significantly more likely to progress to persistent af/at than patients were \<65 years, suggesting that early rf ablation may be an effective treatment strategy for delaying af progression. so, we hypothesize that early af ablation within one year after first af diagnosis may associate with improved procedures outcomes in symptomatic af patients.


Eligibility criteria:
inclusion criteria: * paroxysmal and persistent atrial fibrillation (af) documented on a 12 lead ecg, trans-telephonic monitoring (ttm) or holter monitor (episodes of af must be \>30 seconds in duration to qualify as an inclusion criterion) * age of 18 years or older on the date of consent. * candidate for ablation based on af that is symptomatic * informed consent exclusion criteria: permenant af * previous left atrial (la) ablation or la surgery * af due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery) * active intracardiac thrombus * pre-existing pulmonary vein stenosis or pulmonary vein stent * contraindication to anticoagulation or radiocontrast materials * left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography * cardiac valve prosthesis * severe mitral valve regurgitation or stenosis * myocardial infarction, percutaneous intervention, or coronary artery stenting during the 3-month period preceding the consent date * cardiac surgery during the three-month interval preceding the consent date * significant unrepaird congenital heart defect (including patent foramen ovale) * nyha class iv congestive heart failure * significant chronic kidney disease (egfr \<30 ml/min/1.73m2) * cerebral ischemic event (stroke or transient ischemic attack) during the six-month interval preceding the consent date * pregnancy and life expectancy less than one year

Keywords: early referral, catheter ablation, atrial fibrillation
gulf evaluation of valproate (depakine chrono) in mania study

Conditions: Bipolar Disorder

Summary: to assess the efficacy of di-valproate in bipolar i patients suffering from a manic episode according to dsm iv (apa 1994) over a 12 weeks period of treatment. to evaluate the clinical safety of di-valproate.


Eligibility criteria:
inclusion criteria: * in or out patients * patients with a current diagnosis of bipolar i disorder according to dsm iv (296) * patients suffering from a current manic episode or mixed episode exclusion criteria: * patients who participated in a clinical trial within the three preceding months * patients with a history of valproate intolerance defined as valproate discontinuation due to medically significant adverse effects. * patients with a cns neoplasm, demyelinating disease, degenerative neurological disorder, active cns infection or any progressive disorder * patients with a history of seizure disorder, cerebral vascular disease, structural brain damage from trauma, clinically significant focal neurological abnormalities, known eeg with frank paroxysmal activity or a known ct scan of the brain demonstrating gross structural abnormalities * patients with uncontrolled gastro-intestinal, renal, hepatic, endocrine, cardiovascular, pulmonary, immunological or hematological disease * patients with acute or chronic hepatitis * patients with current or past pancreatitis * patients with recent history (3 months or less) of substance or alcohol dependence according to dsm iv * pregnancy or lactation. women of child bearing age should be using a reliable contraceptive method * patients that require more than 325 mg of aspirin per day * patients with a medical condition which requires the continuous use of medication which could interfere with the evaluation of safety or efficacy of valproate : anticonvulsant or anticoagulant therapy, mao inhibitors, zidovudine * patients having received any depot neuroleptic within six weeks prior to baseline * patients who received antidepressant drugs within 5 days before baseline and patients who received fluoxetine within 20 days * patients judged by the investigator to have serious risk of suicide * patients necessitating an electro convulsive therapy the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
surveillance of kaletra in korean patients

Conditions: HIV-1 Infection

Summary: this single-arm, multi-center, post-marketing surveillance study of kaletra (lopinavir/ritonavir) was conducted in accordance with the approved korean product labeling in participants 2 years of age and older with human immunodeficiency virus type 1 (hiv-1) infection.

participants were observed for up to 48 weeks following the first dose of kaletra. a follow-up visit took place 1-2 weeks after treatment initiation, and subsequent visits occurred at the discretion of the investigators, typically occurring every 3 months. clinical/immunological/virological/laboratory status, kaletra-containing regimen/concomitant medication information, and adverse event information were obtained at follow-up visits.

Eligibility criteria:
inclusion criteria: * patients 2 years of age and above with hiv-1 infection * patients who were prescribed kaletra treatment as per investigator's medical judgment * patients who gave verbal or written authorization to use their personal and health data * patients who started kaletra treatment after study agreement was in place exclusion criteria: * patients with known hypersensitivity to lopinavir, ritonavir or any excipients of the kaletra tablet * patients who were being treated or will be treated with drugs that are contraindicated with kaletra * patients who have been treated with kaletra * patients participating in other clinical trials

Keywords: postmarketing drug surveillance hiv-1 infection kaletra
acp-204 in adults with alzheimer's disease psychosis

Conditions: Alzheimer's Disease Psychosis

Summary: this is a master protocol for 3 independent, seamlessly enrolling, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies in patients with adp * substudy 1 (phase 2) will evaluate efficacy and dose response of acp-204 30 and 60 mg vs placebo. this substudy will be initiated first. * substudies 2a and 2b (both: phase 3) will be confirmatory studies of either both doses (acp-204 30 and 60 mg, respectively) or a single dose from part 1 vs placebo. substudies 2a and 2b will be performed independently of each other and will commence after enrollment of part 1. all 3 substudies will be analyzed independently of each other. each substudy individually will consist of a screening period (up to 49 days); a double-blind treatment period (6 weeks); a safety follow-up period (30 days) for patients not rolling over into an open-label extension study; and vital status follow-up (for patients who terminated their substudy early).


Eligibility criteria:
inclusion criteria: * is male or female and ≥55 and ≤95 years of age living in the community or in an institutionalized setting * meets clinical criteria for possible or probable ad based on the 2011 national institute on aging-alzheimer association (nia-aa) criteria * meets the revised criteria for psychosis in major or mild neurocognitive disorder established by the international psychogeriatrics association (ipa) * has either blood-based biomarker or documented evidence (e.g. positron emission tomography, cerebrospinal fluid biomarker) indicating amyloid plaque deposition and neuropathologic change consistent with ad * has a prior magnetic resonance imaging or computed tomography scan of the brain that is consistent with the diagnosis of ad * meets revised criteria for psychosis in major or mild neurocognitive disorder as per international psychogeriatrics association * mmse score ≥6 and ≤24 * psychotic symptoms for at least 2 months * lives in a stable place of residence and there are no plans to change living arrangements * has a designated study partner/caregiver * able to complete all study visits with a study partner/caregiver * must be on a stable dose of cholinesterase inhibitor or memantine, if applicable exclusion criteria: * requires treatment with a medication prohibited by the protocol * is in hospice and receiving end-of-life palliative care, or has become bedridden * requires skilled nursing care * psychotic symptoms that are primarily attributable to delirium, substance abuse, or a medical or psychiatric condition other than dementia * known history of cerebral amyloid angiopathy, epilepsy, central nervous system neoplasm, or unexplained syncope * atrial fibrillation * symptomatic orthostatic hypotension * protocol-defined exclusionary clinical laboratory findings * treatment with anti-tau therapy or donanemab within 2 months prior to screening additional inclusion/exclusion criteria apply. subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Keywords: alzheimer's disease psychosis hallucinations delusions