Kornimate/medical-research-clean huggingface dataset:
tachy prediction download study

Conditions: Ventricular Tachycardia

Summary: the purpose of the medtronic tachy prediction download (tpd) study is to collect data from an implantable cardiac defibrillator (icd) device that will be used to identify markers for imminent onset of ventricular arrhythmias.

the tpd study is a prospective, non-randomized, non-interventional, multi-site data collection clinical study to collect icd longitudinal data that may be used to develop a vt/vf prediction algorithm. the study subjects will include patients currently implanted, or who will be implanted with a market-approved medtronic evera mri® icd.

Eligibility criteria:
inclusion criteria: * subject is implanted or will be implanted, with an evera mri device with properly functioning medtronic tachycardia lead placed in the right ventricle (with or without atrial lead) with remaining device longevity of 4 years or more for: * secondary prevention or, * primary prevention and has had a device treated vt/vf or a device recorded episode of sustained vt/vf * subject is ≥ 18 years old * subject has previously documented history of vt/vf * subject must be willing and able to use medtronic carelink network monitoring system * subject provides signed and dated authorization and/or consent per institution and local requirements * subject is willing and able to comply with the protocol exclusion criteria: * subject who received device for primary prevention indication and who has not had either a device treated vt/vf episode or a device recorded episode of sustained vt/vf * subject is enrolled in a concurrent study that may confound the results of this study, without documented pre-approval from a medtronic study manager * subject has chronic af * subject has inherited disorders of ion transport mechanisms that predispose the subject to sudden death ("channelopathies"): long qt and brugada syndromes * subject with multiple implanted active devices that may cause an interruption of a transmission of device data to carelink * subject has active electronic medical device other than an icd * subject requires more than 25% atrial or ventricular pacing * subject has medical conditions that would limit study participation (per investigator judgment) * subject has projected life expectancy of less than 1 year * subject is pregnant or plans to be pregnant over the next year (females of child-bearing potential must have a negative pregnancy test within one week of enrollment and must practice a reliable form of birth control while enrolled in the study) * subject meets exclusion criteria required by local law (e.g. age, breastfeeding, etc.)
thrombectomy in mild ischemic stroke with a visible intracranial vessel occlusion

Conditions: Stroke

Summary: the purpose of trimis is to study how a medical procedure by the name of endovascular therapy compares to medical treatment alone in patients with mild stroke and a blood vessel occlusion in the brain


Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke in an adult patient (18 years of age or older). 2. onset (last seen normal) time to treatment time \<24 hours or unknown last seen normal in whom endovascular therapy could be considered per local radiographic guidelines. 3. mild stroke defined as an nih stroke scale ≤ 5 at the time of treatment decision. a. patients with nih stroke scale=0 can be included in the study if they have relevant abnormalities on neurological exam. 4. an acute intracranial vessel occlusion (intracranial internal carotid artery terminus (t or l clot), middle cerebral artery (m1, m2, m3/beyond), anterior cerebral artery (a1, a2, a3), v4, basilar, posterior cerebral artery) defined by non-invasive acute imaging (computed tomography, angiography (computed tomography angiography) or magnetic resonance angiography (mra)) that is neurologically relevant to the presenting symptoms and signs. exclusion criteria: 1. stroke symptoms due to another non-ischemic acute neurological condition such as seizure with post-ictal todd's paralysis or focal neurological signs due to severe hypo- or hyperglycemia. 2. hyperdensity on non-contrast computed tomography consistent with intracranial hemorrhage. any clinical suspicion of any intracranial hemorrhage even in the absence of visible blood on baseline brain imaging. 3. large acute stroke \>1/3 middle cerebral artery territory or alberta stroke programme early ct score (aspects\<6 or established frank hypodensity relevant to the presenting acute stroke already visible on baseline ct scan. 4. findings on acute ct or mri to suggest that the 5. patient has a severe or fatal or disabling illness that will impact decision regarding acute reperfusion therapies. 6. pregnancy. 7. clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic. 8. stroke occurred as an inpatient. 9. inclusion into any randomized control trials.
a research study looking at how the compound nnc0194-0499 works with birth control pills in women not able to bear children.

Conditions: Healthy Volunteers (Non-alcoholic Steatohepatitis)

Summary: the study will investigate the influence of nnc0194-0499 on the blood levels of the two components of a birth control pill, microgynon®. participants will get the birth control pill in form of tablets in two periods of 8 days each. participants will get nnc0194-0499 as injection under the skin of their thigh. the injections will be given once weekly for 5 weeks. the study will last for about 11 to 15 weeks, depending on the length of the screening period. participants will have to stay overnight at the study centre (2 nights and 4 nights, respectively) only healthy women who are not able to bear children can take part in this study.


Eligibility criteria:
inclusion criteria: * female of non-childbearing potential. * age 18-65 years (both inclusive) at the time of signing the informed consent. * body mass index (bmi) between 18.5 and 29.9 kg/m\^2 (both inclusive) at screening. * considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. exclusion criteria: * any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * any contraindications for the use of the oral contraception used in the study according to the prescription drug information. * sitting blood pressure at screening outside the range of 90-139 mmhg for systolic or 50-89 mmhg for diastolic. * pulse outside the range of 50-89 beats/minute at screening * use of prescription medicinal products or non-prescription drugs including any herbal medicine known to interfere with the metabolic cyp pathways, such as hypericum (st. john's wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days before screening. exceptions are: use of routine vitamins (vitamins used within a normal dose reference interval), occasional use of paracetamol, non-steroidal anti-inflammatory drugs (nsaids), or topical medication not reaching systemic circulation. * presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, or endocrinological conditions.
concurrent azeliragon with craniospinal irradiation

Conditions: Solid Tumor; High-grade Glioma; Leptomeningeal Metastasis

Summary: single institution study to assess the safety of concurrent azeliragon with craniospinal irradiation (csi) in patients with leptomeningeal metastasis from solid tumor malignancies and high-grade gliomas.


Eligibility criteria:
inclusion criteria: * patient with solid tumor malignancy or high grade glioma with leptomeningeal metastasis established radiographically and/or through cerebrospinal fluid (csf) cytology * patients who are candidates for radiation therapy for the treatment of leptomeningeal metastasis * patients with karnofsky performance status of 60 or greater. * male or non-pregnant and non-lactating female and ≥ 18 years of age. * patients with absolute neutrophil count (anc) ≥ 1.0 × 109/l, platelet count ≥ 75,000/mm3 (75 × 109/l), and hemoglobin (hgb) ≥ 8 g/dl. transfusion or growth factor support is allowed. * patients with aspartate aminotransferase (ast) \[serum glutamic-oxaloacetic transaminase(sgot)\], alanine aminotransferase (alt) \[serum glutamic-pyruvic transaminase (sgpt)\] ≤ 2.5 × upper limit of normal range (uln), unless liver metastases are present, then ≤ 5 x uln is acceptable, total bilirubin ≤ 1.5 × uln, and estimated creatinine clearance of \> 30 ml/min (per cockroft-gault formula). * patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the informed consent form (icf) prior to participation in any study-related activities. exclusion criteria: * patient has a life expectancy, per investigator assessment, of less than 2 months. * patients unable to complete the english quality of life questionnaires * patient with extensive systemic disease and who declined standard systemic treatment options * patient who is unable to undergo magnetic resonance imaging (mri) brain and spine with gadolinium contrast * previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerance * active, uncontrolled bacterial, or fungal infection(s) requiring systemic therapy. * patient has a concomitant serious medical or psychiatric illness that, in the opinion of the investigator, could compromise the patient's safety or the study data integrity. * patient is unwilling or unable to comply with study procedures, including, but not limited to self-administration of oral medication. * patients with a gastrointestinal condition that could interfere with swallowing or absorption. * females of childbearing potential who are sexually active or males with female partners of childbearing potential, where either the female or the male is unwilling to use a highly effective method of contraception during the trial and for 6 months after the last administration of study drug. * pregnant or lactating women
intensive discharge intervention in diabetes

Conditions: Type II Diabetes; Cardiovascular Disease

Summary: the goal of this study is to design and implement an intensive discharge intervention for inpatients with type 2 diabetes and cardiovascular disease, and determine the effects of the intervention on post-discharge insulin adherence, glycemic control, cardiac medication adherence, hypoglycemic events, and emergency department visits and hospital readmissions.


Eligibility criteria:
inclusion criteria: * adult inpatients at bwh on the medicine or cardiology services with a primary care physician who belongs to a participating practice or has not explicitly opted out of the study * type 2 diabetes * active cardiovascular disease * likely to be discharged home, and one of the following: 1. prescribed insulin prior to admission 2. prescribed two oral agents and with an a1c \> 8.0 within 30 days of admission. - practices that have already agreed to participate in this study for all their eligible patients. exclusion criteria: 1. discharge to a location other than home or rehabilitation (or to a caregiver's home) 2. patient does not administer own medications and absence of a caregiver who lives with patient and administers all medications 3. police custody, no telephone or homeless 4. previous enrolment in the study within 90 days of discharge 5. patient unable to communicate in either english or spanish 6. participation in the integrated care management program (icmp)

Keywords: transitions in care discharge intervention rct readmission rates medication adherence glycemic control ed visits medication reconciliation coleman transitions coach telemonitoring; hypoglycemic events
aerobic exercise training in patients with chronic hepatitis b and hepatic steatosis

Conditions: Hepatitis B, Chronic; Hepatic Steatosis

Summary: this study is a randomised, controlled, unblinded, clinical intervention trial consisting of 12 weeks of aerobic exercise training. thirty persons with chronic hepatitis b (chb) and hepatic steatosis are randomised to either aerobic exercise training (intervention group, n=15) or no intervention (control group, n=15). the study will investigate the effects of the exercise intervention on the liver and the hypothesis is that the exercise group will reduce the fat-fraction of the liver after the intervention.

primary aim: to investigate whether regular aerobic exercise training will decrease the fat-fraction of the liver in persons with chb and hepatic steatosis shown by magnetic resonance imaging (mri) by use of iterative decomposition of water and fat with echo asymmetry and least squares estimation (ideal-iq). secondary aim: to investigate the effects of aerobic exercise training on hepatokine secretion in persons with chb and hepatic steatosis. also, to investigate if regular physical exercise will improve lipid- and glucose metabolism, liver status, markers of inflammation, body composition, and blood pressure. study participants will undergo pre and post the interventioon: clinical examination with ecg, blood pressure measurements, blood sampling, oral glucose tolerance test, a hormone infusion of somatostatin and glucagon, -increasing the glucagon/insulin ratio mimicking an acute exercise bout, measuring the effect on circulating hepatokines and cytokines, fibroscan, vo2-max test, dxa scan, ax3 activity monitoring, nail fold capillaryscopy, iqola sf-36 and ipaq-sf questionnaire, 24h food intake registration, mri scan of the liver and optional liver biopsy. 6 and 12 months follow-up is planned. the exercise intervention will be randomised 1:1 with no stratification: the training program includes three weekly supervised training sessions of 40 minutes/session over 12 weeks. participants are instructed not to change their lifestyles during the intervention.

Eligibility criteria:
inclusion criteria: * chronic hepatitis b defined by hbsag positive \>6 months * positive hbv-dna * age \>30 * hepatic steatosis diagnosed by controlled attenuated parameter (cap) \>250 assessed by transient elastography or by ultrasound defined hepatic steatosis exclusion criteria: * hiv, hcv, hdv-co infection * primary biliary cholangitis * wilsons disease * autoimmune hepatitis * hepatocellular carcinoma * antiviral medication * steatogenic medication (systemic corticosteroids, amiodarone, tamoxifen, valproic acid, and methotrexate) * average alcohol intake \>30 g for men and \>20 g for women pr. day * contraindications for mri scan * coronary artery disease contraindicating hiit * unable to understand and read written information for participants written consent * pregnancy
validity and reliability of the turkish version of breathlessness beliefs questionnaire

Conditions: Dyspnea; COPD

Summary: in our study, we aimed to evaluate the validity and reliability of the turkish version of the breathlessness beliefs questionnaire-bbq in our study.

pulmonary diseases are a common cause of mortality and morbidity throughout the world. in pulmonary diseases such as asthma and copd, the main symptom is dyspnea and it causes activity limitation. dyspnea is defined as the difficulty that a person experiences during breathing. as a result of painful situations or injuries, avoidance of physical activity or movement due to the fear of repetition of the problem are defined as kinesophobia. pulmonary patients are compensated by reducing the rate of activity, while avoiding dyspnea.this reduces the severity of the symptom that precedes the symptom that may occur. as a result, dyspnea causes kinesyphobia. decrease in the level of activity; social isolation, fear of dyspnea, depression and anxiety result in a stubborn cycle, quality of life is reduced. the breathlessness beliefs questionnaire (bbq) was developed based on the tampa kinesiophobia scale to assess dyspnea and dyspnoea-related kinesophobia and anxiety in respiratory diseases.

Eligibility criteria:
inclusion criteria: * fev1/fvc\<%70 * to be able to read and understand turkish exclusion criteria: * having undergone a copd exacerbation in the last 6 weeks * having comorbidities affecting ambulance * having cognitive disorders

Keywords: copd dyspnea kinesiophobia
evaluation of the difference in the acromion humerus gap at sitting,lying

Conditions: Shoulder Impingement Syndrome.

Summary: the objective is to evaluation the difference between the upper end of the humerus head and the bottom end of the acromion in sitting and lying, and to examine this difference to shoulder pain.


Eligibility criteria:
inclusion criteria: * men and women with or without shoulder pain. exclusion criteria: * unwillingness to sign informed consent
lepirudin in treating patients with recurrent or advanced small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: anticoagulants, such as lepirudin, may help prevent blood clots from forming in patients who have received chemotherapy for small cell lung cancer. purpose: this phase i/ii trial is studying the side effects and best dose of lepirudin in treating patients with recurrent or advanced small cell lung cancer.

objectives: i. determine the dose, safety, and antitumor response rate of lepirudin in patients with recurrent or extensive stage small cell lung cancer previously treated with chemotherapy. outline: this is a dose escalation (in individual patients) study. patients receive dose escalated lepirudin subcutaneously once or twice a day for 3-4 days. dose escalation continues in each patient until aptt prolongation occurs or the maximum dose level is reached. the patient then continues treatment on the maximum tolerated dose. treatment continues in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 20-35 patients will be accrued for this study within 18-24 months.

Eligibility criteria:
disease characteristics: 1. pathologically confirmed recurrent or extensive stage small cell lung cancer. 2. received at least one prior chemotherapy regimen 3. measurable or evaluable disease that has not been irradiated 4. no pleural effusions, bone metastases, brain metastases, elevated serum enzymes, or radionuclide scans as the sole indicator lesion 5. brain metastases allowed if patients received cranial irradiation and have no clinical evidence of brain metastases patient characteristics: 1. age: not specified 2. performance status: karnofsky 60-100% 3. life expectancy: not specified 4. hematopoietic: wbc at least 3,000/mm3 platelet count at least 100,000/mm3 5. hepatic: bilirubin no greater than 2.0 mg/dl pt and aptt normal 6. renal: creatinine no greater than 1.5 mg/dl or creatinine clearance greater than 60 ml/min 7. cardiovascular: no unstable heart rhythm no unstable angina no clinical evidence of congestive heart failure no prior cerebrovascular accident or stroke no uncontrolled or severe hypertension 8. other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception 9. at least 6 weeks since any signs or symptoms of bleeding no history of bleeding disorder 10. no bacterial endocarditis or other active infection prior concurrent therapy: 1. biologic therapy: not specified 2. chemotherapy: at least 3 weeks since prior chemotherapy 3. endocrine therapy: not specified radiotherapy: at least 3 weeks since prior radiotherapy 4. surgery: at least 6 weeks since major surgery, trauma, or needle biopsy of any organ 5. other: no concurrent anticoagulant or platelet inhibitor therapy

Keywords: extensive stage small cell lung cancer recurrent small cell lung cancer
genetic and phenotypic characteristics of mitral valve prolapse

Conditions: Mitral Valve Prolapse; Genetic Disease

Summary: phenotypic characterisation of mvp by echocardiography in families. identification of genes involved in mvp.

after clinical identification of patients with mvp, doctors organize 1st degree relative familial screening. a comprehensive echocardiography was carried out along with clinical examination. all echo data were stored for off-line analysis by a sonographer in our core-lab. blood was sample at the time of echocardiography in adult patients for dna analyses. follow-up for mitral valve changes will be performed after 5 years.

Eligibility criteria:
inclusion criteria: * patients of any age * with typical mitral valve prolapse * relatives examined during familial screening exclusion criteria: * refusal of the patient

Keywords: mitral valve prolapse genetic echocardiography
cholangioscopic assessment of occluded biliary stent and role of biliary radiofrequency ablation

Conditions: Obstructive Jaundice; Cholangitis

Summary: primary objective: to document state-of- the-art multi-modality management of occluded biliary sems aiming to minimize number of reinterventions while providing symptom relief without procedure-related serious adverse events. note: this study will be hypothesis-generating for an anticipated randomized controlled study (rct) to compare outcomes of placement of a plastic stent inside the occluded sems to outcomes of the proposed multi-modality approach.

study design: prospective, multi-center, single arm, post market, observational study two groups: * sludge group: sems occluded due to sludge/stones in sems * ingrowth/overgrowth group: sems occluded due to malignant tumor ingrowth or benign hyperplastic tissue overgrowth primary endpoint: successful restoration of bile duct drainage with biliary obstructive symptom and cholangitis relief as applicable, without procedure related sae's, from procedure through 30 days of follow-up. secondary endpoints: 1. occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure 2. resolution of cholangitis where applicable 3. technical success of procedure performed for restoration of bile duct drainage, overall and stratified by treatment group sludge group: ability to restore stent patency by cleaning the stent content followed by cholangiographically or cholangioscopically confirmed restored stent patency ingrowth / overgrowth group: ability to perform biliary radio frequency ablation (rfa) followed by cholangiographically or cholangioscopically confirmed restored stent patency 4. improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to baseline 5. improvement of laboratory liver function tests (lft) at 1 week and 1 month post procedure compared to baseline 6. biliary reintervention rate from procedure through 30 days after procedure, including reinterventions caused by plastic stent occlusion 7. impact of cholangioscopy on current standard of care, which is to place a stent inside the occluded sems by * avoiding placement of a second stent (plastic or metal) * avoiding a repeat ercp * reducing associated cost

Eligibility criteria:
inclusion criteria: * 1. age 18 or older 2. willing and able to comply with the study procedures and provide written informed consent to participate in the study 3. recurrent biliary obstructive symptoms after biliary sems placement 4. biliary sems occlusion. exclusion criteria: * 1. contraindications for endoscopic techniques 2. ongoing cholangitis. note: in case a patient presents who meets the inclusion and exclusion criteria, but has cholangitis, then a naso-biliary drain (nbd) will be placed before the ercp until the cholangitis resolves.

Keywords: obstructive jaundice self expandable metal stents (sems) cholangitis