Kornimate/medical-research-clean huggingface dataset:
a case controlled etiologic study of sarcoidosis (access)

Conditions: Lung Diseases; Sarcoidosis

Summary: to test specific hypotheses concerning environmental, occupational, lifestyle, and other risk factors for sarcoidosis. also, to examine the familial aggregation of sarcoidosis and to test genetic hypotheses concerning its etiology. finally, to describe the natural history of sarcoidosis, particularly in african-americans who appear to be disproportionately affected, and to implement a system for storing biological specimens including blood cells, plasma, and serum.

background: sarcoidosis is a systemic granulomatous disorder of unknown etiology. while recognized as a distinct clinical entity for over a century, information on incidence, prevalence, risk factors, and natural history in the united states remains quite limited. data available on the occurrence in the united states indicate that the incidence ranges from about 1 to 10 per 100,000 and prevalence from about 5 to 50 per 100,000. incidence appears highest for young adults, ages 25 to 40, higher in females than males, and much greater in african americans than other ethnic groups. morbidity from this chronic disease is not well estimated by mortality data. in 1981, there were over 10,000 discharges from united states hospitals for sarcoidosis. like mortality data, the hospital discharge information probably substantially underestimates the morbidity associated with sarcoidosis which is typically managed on an outpatient basis. the requests for proposals were issued in september, 1994. awards were made in june, 1995. design narrative: each of ten clinical centers enrolled patients with sarcoidosis. because population-based case-finding mechanisms have not been widely implemented for sarcoidosis, an institution-based rather than a population-based design was used. participating institutions were located in geographic regions where the disease was known and ethnic and gender factors could be addressed. several investigator-initiated studies were carried out. in addition to etiology, access examined the socioeconomic status and clinical course of patients with sarcoidosis. newly diagnosed cases of sarcoidosis were compared to age, sex, and race matched controls. leads to the etiology of sarcoidosis have come from diverse sources: in clinical laboratory investigations, alveolitis has been found to precede granulomatous inflammation; in case control studies, familial aggregation has been identified; and in case reports, recurrence of granulomatous inflammation has been observed after lung transplantation.

Eligibility criteria:
no eligibility criteria
phenotypes, biomarkers and pathophysiology in hereditary spastic paraplegias and related disorders

Conditions: Hereditary Spastic Paraplegia

Summary: the aim of this study is to determine the clinical spectrum and natural progression of hereditary spastic paraplegias (hsp) and related disorders in a prospective multicenter natural history study, identify digital, imaging and molecular biomarkers that can assist in diagnosis and therapy development and study the genetic etiology and molecular mechanisms of these diseases.

the investigators will perform a registry-based standardized prospective natural history study (nhs) in hsps and related disorders. participants will be seen annually. at study visits a standardized clinical examination will be performed including application of clinical rating scales (selection of rating scales may vary depending on the individual phenotype and specific genotype); data will be entered into a clinical database (hsp registry; https://www.hsp-registry.net). at all study visits, patients will be asked to donate biosamples; biomaterial collection is optional and participants can elect to participate in sampling of blood, urine, csf, and/or a skin biopsy. optionally, additional examinations may be performed including imaging, quantitative movement analysis, neuropsychological examinations, analysis of patient or observer reported outcomes and omics analysis to characterize molecular biomarkers. in participants without a genetic diagnosis, next generation sequencing may be performed.

Eligibility criteria:
inclusion criteria: * one of the following: 1. primary participant: clinical or genetic diagnosis of hsp or a related disorder 2. secondary participant: unaffected family member (1st or 2nd degree relative) of primary participant (with the above-mentioned restrictions for special populations) able to give informed consent 3. unrelated healthy control able to give informed consent and * written informed consent and - participants are willing and able to comply with study procedures exclusion criteria: * missing informed consent of primary or secondary participant/ healthy control/ legal representatives * for controls: evidence of a neurodegenerative disease or movement disorders; inability to give informed consent

Keywords: hereditary spastic paraplegia biomarker genetic etiology molecular mechanisms
sspc evaluation on carotid artery stenosis after endarterectomy

Conditions: Carotid Stenosis; Carotid Artery Diseases; Carotid Artery Plaque

Summary: sspc includes degree of stenosis, symptoms, plaque stability and compensation of the cerebral blood flow. sspc, a comprehensive evaluation system on carotid artery stenosis, is established and advocated in this trial in order to make assessment on risk of carotid revascularization preoperatively and prediction of cerebral events postoperatively.

although, cerebral perfusion and collaterals recruitment are crucial and integral to current treatment and stroke prevention paradigms, most consensus recommendations do not include assessments of cerebral hemodynamics in their management algorithms and arbitrarily focus on symptoms and degree of stenosis. based on four aspects of sspc multidimensional assessment and grading, through clinical data, specimen collection, image technology of the multi-disciplinary cross research, we initially to propose a more scientific evaluation system for the perioperative period of carotid revascularization, to reveal the scientific mechanism of brain function changes after carotid revascularization, and to establish a method for the evaluation of brain function after carotid revascularization in accordance with the characteristics of chinese lesions.

Eligibility criteria:
inclusion criteria: 1. patient or patient's legal representative have been informed of the nature of the study, agrees to participate and has signed an ethical committee approved consent form 2. unilateral or bilateral carotid artery stenosis diagnosed by ultrasound or ct angiography. 3. complete revascularization followed by carotid endarterectomy or carotid artery stenting. exclusion criteria: 1. patients with carotid stenosis received best medicine therapy. 2. patients for whom antiplatelet therapy, anticoagulants, medium contrast, or thrombolytic drugs are contraindicated. 3. patient has bleeding diathesis, coagulopathy, known hypercoagulable condition or refuses blood transfusion 4. female patient with childbearing potential not taking adequate contraceptives or currently breastfeeding. 5. life expectancy of less than twelve months. 6. patient is currently participating in another investigational drug or device study that has not completed the entire follow up period. 7. patient presenting one of the following comorbid conditions: hemodialysis, elevated creatine levels (\> 2.5mg/dl), recent mi or ischemic stroke occurrence (both within 30 days). 8. patient unwilling or unlikely to comply with follow-up schedule

Keywords: carotid stenosis carotid revascularization symptoms degree of stenosis plaque cerebral compensation
interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease

Conditions: Heart Failure, Systolic; Renal Disease, End Stage; Chronic Kidney Diseases

Summary: interleukin-1 blockade for the treatment of heart failure in patients with advanced chronic kidney disease (end-stage renal disease and heart failure - anakinra remodeling trial) is a phase 2, single-arm trial designed to estimate the effect of anakinra, a recombinant human interleukin-1 (il-1) receptor antagonist, on cardiorespiratory fitness in patients with advanced chronic kidney disease and heart failure.


Eligibility criteria:
inclusion criteria: * written informed consent * 18 years or older * chronic heart failure * left ventricular ejection fraction less than 50% * c-reactive protein greater than or equal to 2 mg/l * maintenance hemodialysis with a biocompatible membrane, acceptable dialysis adequacy (kt/v \> 1.2), and receipt of a stable hemodialysis prescription for at least 4 weeks or chronic kidney disease stage iv/v (estimated glomerular filtration rate \<30 ml/min/1.73m2) exclusion criteria: * inability to complete maximal cardiopulmonary exercise testing * need for urgent or emergent care * recent use of immunosuppressant, anti-inflammatory therapies or active rheumatologic disease * allergy to rubber, latex, escherichia coli or anakinra

Keywords: heart failure end-stage renal disease interleukin-1 interleukin-1 receptor antagonist metabolomics lipidomics chronic kidney disease
miltefosine for mucosal leishmaniasis

Conditions: Leishmaniasis

Summary: this trial will study miltefosine as a treatment for mucosal leishmaniasis.

treat bolivian mucosal leishmaniasis with miltefosine.

Eligibility criteria:
inclusion criteria: * mucosal leishmaniasis exclusion criteria: * abnormal liver function tests (lft) * abnormal kidney function test * concomitant diseases

Keywords: mucosal leishmaniasis miltefosine
safety, tolerability and pharmacokinetics of aut00206 in patients with schizophrenia, and also explores the effects of aut00206 on relevant central biomarkers.

Conditions: Schizophrenia

Summary: this study will investigate the safety, tolerability, pk and pd profile of aut00206 after repeated doses in patients with stable but symptomatic schizophrenia, taking one or two established anti-psychotic drugs. the subjects will undergo brain imaging, tests of cognition and tests of auditory function and electrophysiological measures in addition to routine safety monitoring. because of the pioneering and novel mechanism of action of this drug, a key objective is to characterize this range of biomarkers which will inform the future development of the drug.


Eligibility criteria:
key inclusion criteria: * male patients with a diagnosis of schizophrenia no more than 5 calendar years (before screening); * positive and negative symptoms assessed by panss; * medically and psychiatrically stable; * on a stable dose of antipsychotic drugs; * able to give fully informed written consent and likely to comply with the requirements of the trial. key exclusion criteria: * clinically relevant, as assessed by a physician, abnormal findings at the screening assessment; * sensitivity to excipients of the trial medication; * current use of contraindicated drugs; * participation in another clinical trial of unlicensed medicines within the previous 30 days; * loss of more than 400 ml blood, within the previous 3 months; history of drug or alcohol dependence in the last year; * significant acute or chronic illness; * significant medical history or concurrent medical condition that warrants exclusion; * objection by subject's physician
effect of zopiclone on compliance with continuous positive airway pressure in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the clinical population targeted will be newly diagnosed patients with polysomnographically diagnosed osa who are not currently taking hypnotics for concomitantly diagnosed insomnia. outpatients who are also judged to be capable to follow the study procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent disease that in the view of the investigator will interfere with participation in the trial to completion will be included. approximately 160 subjects were recruited (80 per treatment arm) in the recent trial of eszopiclone. this size is expected to be able to discern an important difference of 80 minutes per night. in the current clinical population newly prescribed cpap at mount sinai hospital, the average compliance after 4 weeks of initiation of ncpap was 4:01 (sd 2:59) hours per night. to be able to discern a difference of at least 1 hour (60 minutes) in usage per night, including entirely non-adherent patients who do not use treatment at all as 'zero hour' users, would require randomization of 264 patients (132 per group). our hypothesis for this study is that initial titration of cpap treatment of osa may be improved by initial prescription of a common hypnotic, zopiclone. to answer this question we intend to recruit 264 consecutive consenting subjects with osa confirmed by a physician (absm or by a respirologist with extensive sleep medicine experience) with supportive polysomnography results who are willing to initiate long-term cpap treatment.

background: obstructive sleep apnea (osa) is a common sleep breathing disorder that is associated with serious complications. continuous positive airway pressure (cpap) is the treatment of choice for most patients but its use in the real world is limited by low patient adherence which may result in sub-optimal outcomes for some patients. a single hypnotic with low risk of adverse effects is a cost-effective intervention to augment the currently low adherence to cpap, especially if only prescribed for a limited time. the hypnotic is generic zopiclone 3.75-7.5 mg at bedtime for up to 14 doses. the clinical population targeted will be newly expert physician-diagnosed patients polysomnographically supported osa who are not currently taking hypnotics for concomitantly diagnosed insomnia. outpatients who are also judged to be capable to follow the study procedures (consent, timelines, visits, questionnaires) and who do not have any concurrent disease that in the view of the investigator will interfere with participation in the trial to completion will be included.

Eligibility criteria:
inclusion criteria: * md diagnosis of obstructive sleep apnea * no previous use of cpap * no concurrent use of hypnotic medication exclusion criteria: * fatal comorbidities (i.e., life expectancy less than 6 months) * contraindications for cpap use * pregnancy * liver failure
effects of cariprazine on cardiac repolarization in patients with schizophrenia

Conditions: Schizophrenia

Summary: this study will evaluate the effects of sequential multiple dose regimens of cariprazine on cardiac repolarization in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * men or women, age 18 to 50, inclusive * symptoms of schizophrenia or schizoaffective disorder first appearing a minimum of 1 year before screening * negative pregnancy test * normal physical examination results, vital signs, and clinical lab test results exclusion criteria: * axis ii disorder severe enough to interfere with the study * smoking more than 20 cigarettes a day * history or presence of cardiovascular disorder * pregnant/breast-feeding and/or planning to become pregnant/breast-feed * imminent risk of injuring self or others or causing significant property damage

Keywords: schizophrenia qtc cardiac repolarization
feasible insulin algorithm for glycemic control in patients with acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the study aims to demonstrate that a simple intravenous insulin algorithm can be implemented in latin america and will result in safe and better glucose control in patients with acute coronary syndrome (acs) compared with sc insulin.

the proposed study is a one center open-label randomized controlled clinical trial.coronary intensive care of one hospital in the city of curitiba, pr, brazil will be assessed. consenting eligible subjects will be randomized to either the intensive insulin infusion therapy group (itg) or the conventional therapy group (ctg). this particular insulin infusion was adapted of a protocol has been used before in patients who underwent to cardiothoracic surgery and its efficacy has been reported in the literature. the control group will be selected following the same set of inclusion and exclusion criteria. patients will be randomized to receive sc regular insulin 4 times daily (before meals and bedtime) or every 6 hours if they are npo . data will be collected for history of diabetes, heart disease ; hypertension; hyperlipidemia; current smoker; cardiac treatment (aspirin, beta blockers, ace inhibitor/a2rb, nitrates, statin, fibrate) diabetes treatment(insulin, metformin, sulphonylureas) data will be collect for baseline bgl , a1c level, troponin, cpk, ckp-mb, k, creatinine. classify infarct type : anterior/anteroseptal, inferior, non-st-segment elevation myocardial infarction, not classified cardiac intervention : ptca , thrombolysis,no reperfusion, heparin or low-molecular weight heparin. subjects allocated to itg will be placed on grady health system protocol, and those in ctg will follow the sliding scale nomograms. insulin replacement will start during first 24h of admission. patients will be followed during all hospital stay, but only at icu the ciii and sc insulin replacement will be compared. after icu discharge they will follow they will be followed by their physician with recommendations to keep blod glucose\<180mg/dl. patients will be followed up to 90 days after hospital discharge with phone call.subjects will be contacted to obtain information regarding the occurrence of cardiovascular events following discharge. if the subject is not contactable, the next of kin and/or the subject's general practitioner would be contacted. where no information could be obtained, a request will be made to the department of births and deaths.

Eligibility criteria:
inclusion criteria: * male or female * age 18 or older * evidence of ami within the last 24 h (troponin-t \>0.1mcg/l) or electrographic criteria of st-segment elevation in two limb leads) * evidence of unstable angina * blood glucose \>180mg/dl at admission with or without preexisting diabetes * willing to give informed consent * access to telephone communications after hospital discharge exclusion criteria: * under 18 years of age * pregnant or lactating female * diabetes ketoacidosis * heart failure * cardiogenic shock

Keywords: intensive insulin therapy glucose control acute coronary syndrome intensive care
dexcom g6 for total pancreatectomy with islet autotransplantation (tpiat) patients

Conditions: Diabetes

Summary: a single-center prospective trial on the effects of standard of care radiation exposure on the dexcom g6 continuous glucose monitoring (cgm) device.

to determine if standard of care radiation exposure longitudinally effects the accuracy and precision of the g6 transmitter in the post tpiat in-patient population. reduce burden for patients to remove and waste a functional and expensive dexcom g6 cgm for radiologic procedures.

Eligibility criteria:
inclusion criteria: * planned tpiat at cchmc * staying in-patient at cchmc post tpiat * planned to receive a dexcom g6 cgm exclusion criteria: • hemo- or peritoneal dialysis

Keywords: dexcom g6
study of estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial ibcsg 24-02

Conditions: Breast Cancer

Summary: rationale: studying samples of blood from patients with breast cancer in the laboratory may help doctors learn how well triptorelin given together with tamoxifen citrate or exemestane works in lowering estrogen levels. purpose: this clinical trial is studying estrogen levels in premenopausal women who have undergone surgery for breast cancer and are receiving triptorelin and tamoxifen citrate or exemestane on clinical trial ibcsg-2402.

objectives: primary * describe estrogen levels (estradiol \[e2\], estrone \[e1\], and estrone sulphate \[e1s\]) at different time points during the first 4 years of treatment with triptorelin in combination with either tamoxifen citrate or exemestane on clinical trial ibcsg-2402 in premenopausal women with resected breast cancer. * assess whether there is a suboptimally estrogen-suppressed subgroup of patients who receive exemestane. secondary * compare estrogen levels (e2, e1, e1s) at different time points during treatment with triptorelin in combination with either tamoxifen citrate or exemestane. * examine potential predictive factors of ineffective estrogen suppression (e.g., age, chemotherapy \[yes/no\], type of chemotherapy received, smoking history, bmi, and evidence of menses at study entry). * investigate the predictive value of optimal estrogen suppression during the first 6 and 12 months of treatment with regard to long-term estrogen suppression (4-year period). * compare disease-free survival of suboptimally estrogen-suppressed patients treated with exemestane with that of patients with optimal suppression (exploratory analysis). * examine related endocrine function (fsh and lh) to further elucidate causes of suboptimal estrogen suppression. outline: this is a multicenter study. blood samples are collected at baseline and at 3, 6, 12, 18, 24, 36, and 48 months for measurement of estrogen levels (estradiol \[e2\], estrone \[e1\], and estrone sulphate \[e1s\]) by gas chromatography-mass spectrometry and measurement of endocrine function (fsh and lh).

Eligibility criteria:
disease characteristics: * histologically confirmed resected breast cancer * concurrent enrollment on clinical trial ibcsg-2402 (soft trial) required * randomized to receive triptorelin in combination with either tamoxifen citrate or exemestane * hormone receptor status: * estrogen receptor- and/or progesterone receptor-positive tumor patient characteristics: * premenopausal prior concurrent therapy: * see disease characteristics

Keywords: estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer