Kornimate/medical-research-clean huggingface dataset:
safety and electrical performances of xfine leads

Conditions: Bradycardia

Summary: the purpose of the study is to confirm the safety and the electrical performances of the xfine passive pacing leads, for both right ventricular (rv) straight models and right atrial (ra) j-shape models, up to 12 months follow-up post implant.

all subjects will be followed until 12 months follow-up post implant. at each follow-up visits (3, 6 and 12 months), electrical performances will be measured and safety will be monitored during the whole study duration.

Eligibility criteria:
inclusion criteria: 1. any subject newly implanted according to the most recent guidelines from the european society of cardiology (esc) for less than10 days with: * a single chamber (sr) or a dual chamber (dr) pacemaker from microport crm s.r.l. * any right atrial and/or right ventricular xfine lead 2. have reviewed, signed and dated the informed consent exclusion criteria: 1. included in another clinical study that could confound the results of this study such as studies involving intra-cardiac device 2. contraindication to a maximum single dose of 310 µg dexamethasone sodium phosphate (dsp) 3. tricuspid valvular disease or tricuspid replacement heart valve (mechanical or tissue) only for subject with dr pacemaker 4. active myocarditis, pocket and/or lead infection 5. age less than 18 years old or under guardianship or kept in detention 6. life expectancy less than 1 year 7. known pregnancy, women breastfeeding or in childbearing age without an adequate contraceptive method 8. be unavailable for the scheduled follow-up associated with this clinical study or refusal to cooperate
safety and efficacy of pasireotide long acting release (lar) vs. octreotide lar in patients with active acromegaly

Conditions: Acromegaly

Summary: the patients received either pasireotide lar or octreotide lar for one year of treatment. the objective of this study was to compare the proportion of patients with a reduction of mean gh level to \<2.5 µg/l and the normalization of igf-1 to within normal limits (age and sex related) between the two treatment groups (pasireotide lar and octreotide lar) at 12 months. following one year of treatment patients could proceed into the study extension. patients who did not respond to the treatment they were randomized to (based on month 12 assessment results) were switched to the other treatment arm at month 13.


Eligibility criteria:
inclusion criteria: * patients with active acromegaly (based on elevated gh and igf-1 levels) * patients who have undergone one or more pituitary surgeries, but have not been treated medically, or de-novo patients presenting a visible pituitary adenoma on mri and who refuse pituitary surgery or for whom pituitary surgery is contraindicated * patients for whom written informed consent to participate in the study has been obtained prior to any study related activity exclusion criteria: * patients who are being or were treated with octreotide, lanreotide, dopamine agonists or gh antagonists with the exception of a single dose of short-acting octrotide or short-acting dopamine agonists. in case of a single dose of short-acting octrotide, the dose should not be used to predict the response to the octretide treatment. the single dose of short-acting octreotide or short-acting dopamine agonists should not be administered in the 3 days prior to randomization * patients with compression of the optic chiasm causing any visual field defect * patients who have received pituitary irradiation within the last ten years prior to visit 1 * poorly controlled diabetic patients other protocol-defined inclusion/exclusion criteria may apply

Keywords: acromegaly, adult, growth hormone, insulin-like growth factor i, somatostatin analogue
effect of metformin on decrement in levothyroxin dose required for thyroid stimulating hormone (tsh) suppression in patients with differentiated thyroid cancer

Conditions: Malignant Neoplasm of Thyroid Stage I; Malignant Neoplasm of Thyroid Stage II

Summary: differentiated thyroid cancer is the most common neoplasm of endocrine system. after surgery and radioiodine treatment, thyroid stimulating hormone (tsh) suppression is the main goal which is achieved with levothyroxine treatment. levothyroxine causes increased thyroid hormones which can have negative impact on bone and cardiovascular system. anecdotal reports have shown that metformin can induce tsh suppression without change in t3 and t4 concentration. the purpose of this study was to prescribe metformin as additional drug to levothyroxin in order to decrease levothyroxine dosage.


Eligibility criteria:
inclusion criteria: * papillary or follicular thyroid cancer * stage 1 or 2 according to tnm system version 6 * surgery and radioiodine treatment * levothyroxine suppression treatment exclusion criteria: * cardiopulmonary failure * liver failure * renal failure * pregnancy * drugs (colestyramin, sucralfate, phenobarbital, phenytoin, carbamazepin, rifampin, amiodarone, chloroquin, androgens, sertraline, frusemide, heparin)

Keywords: differentiated thyroid cancer ths suppression metformin
a study of radiotherapy combined with raltitrexed and irinotecan in metastatic or locally recurrent colorectal cancer

Conditions: Recurrent Colorectal Cancer

Summary: the study evaluates the effectiveness of radiotherapy combined with raltitrexed and irinotecan in treating patients who have metastatic or locally recurrent colorectal cancer that has not responded to fluorouracil. the patients will receive radiotherapy combined with raltitrexed and irinotecan, and then the surgeons will evaluate whether they should receive a surgery.


Eligibility criteria:
inclusion criteria: * histologically proven metastatic, advanced, or locally recurrent fluorouracil (5-fu) and oxaliplatin refractory adenocarcinoma of the colon or rectum; progression of disease within 6 months of receiving adjuvant 5-fu and oxaliplatin chemotherapy or progression of disease during or following completion of 5-fu and oxaliplatin chemotherapy for metastatic disease * evaluable lesions with indications of radiotherapy * no other metastatic lesions in the radiation field * karnofsky performance status\>=70 * ugt1a1\*28 6/6 or 6/7 * subject blood routine and biochemical indicators meet the following criteria: hemoglobin ≥ 90g / l; absolute neutrophil count (anc) ≥ 1.5 × 109 / l; alanine transaminase (alt), aspartate aminotransferase (ast) ≤ 2.5 times the upper limit of normal; alkaline phosphatase (alp) ≤2.5 times the normal upper limit; serum total bilirubin \<1.5 times the normal upper limit; serum creatinine \<1 times the normal upper limit; serum albumin ≥ 30g / l * able to follow the protocol during the study period * sign the inform consent exclusion criteria: * pregnant or breastfeeding women * if there is an uncontrolled history of epilepsy, central nervous system disease or mental disorder, the investigator may determine that the clinical severity may hinder the signing of informed consent or affect the patient's oral medication compliance. * clinically severe (ie, active) heart disease, such as symptomatic coronary heart disease, new york heart association (nyha) class ii or more severe congestive heart failure or severe arrhythmia requiring medication intervention (see appendix 12), or a history of myocardial infarction in the last 12 months * organ transplantation requires immunosuppressive therapy * severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases * anyone who is allergic to any research medication

Keywords: recurrent colorectal cancer irinotecan raltitrexed chemoradiotherapy
safety and efficacy of propranolol in the treatment of tardive dyskinesia

Conditions: Tardive Dyskinesia

Summary: tardive dyskinesia (td) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. there is no way to prevent td except preventing exposure to the inciting agents and there are no approved symptomatic therapies. propranolol is an fda-approved β-blocker with limited data supporting its use as a treatment for td. the goal of this study is to determine the efficacy of propranolol in the treatment of td in a double-blind, cross-over prospective manner. if propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of td with a medication that is known to be safe and inexpensive.

tardive dyskinesia (td) is a disabling, embarrassing and often irreversible iatrogenic movement disorder that can occur in anyone exposed to drugs that block dopamine receptors, including first and second generation antipsychotics and antiemetic agents. there is no way to prevent td except preventing exposure to the inciting agents and there are no approved symptomatic therapies. propranolol is an fda-approved β-blocker with limited data supporting its use as a treatment for td. the goal of this study is to determine the efficacy of propranolol in the treatment of td in a double-blind, cross-over prospective manner. patients with a diagnosis of td will be randomized to propranolol or identical placebo. the patients will be treated for eight weeks, complete a one week washout and then crossed over for another eight weeks. hence, the subjects will be their own controls. participation in this pilot trial will provide placebo controlled blinded data that will assist in planning a larger phase ii trial. if propranolol is found to be an effective therapy, it will fulfill a great need in the treatment of td with a medication that is known to be safe and inexpensive.

Eligibility criteria:
inclusion criteria: * age 18-75 years * diagnosis of classical td by a movement disorder expert for at least 6 months with a baseline score of at least 2 on two of the seven items on the aims severity scale * stable on medication (either on or off dopamine blocking agents) for at least six months. exclusion criteria: * breastfeeding * pregnant * unstable psychiatric disease * history of asthma or copd * baseline heart rate less than 60 * history of orthostatic hypertension or its presence at screening * history of congestive heart failure or unstable angina pectoris * resting sbp \<100 and dbp \< 60 * av-block ii or iii without pacemaker * history of diabetes mellitus * previous adverse effects from use of beta-blockers * current use of a β-blocker and the other following drugs: quinidine, amiodarone, propafenone, digoxin, verapamil, diltiazem, clonidine, and warfarin * tremor, dystonia, akathisia or other non-tardive movement disorder * any medical illness that precludes treatment with propranolol.

Keywords: propranolol safety efficacy tardive dyskinesia treatment
fst-100 ophthalmic suspension in acute adenoviral conjunctivitis

Conditions: Acute Adenoviral Conjunctivitis

Summary: the objective of this study is to evaluate the efficacy of fst-100 (pvp-i 0.4% and dexamethasone 0.1%) ophthalmic suspension in the treatment of suspected acute adenoviral conjunctivitis.


Eligibility criteria:
inclusion criteria: * conjunctivitis within seven (7) days of initial ocular symptoms of redness and/or discharge. * clinical suspicion of adenoviral etiology. * at least three (3) years of age. * subjects or their guardians capable of understanding the purpose and risks of the study, and able to give informed consent. * conjunctivitis diagnosis defined as presence of the two cardinal signs of acute conjunctivitis: 1. conjunctival injection/inflammation, and 2. conjunctival discharge/exudates. exclusion criteria: * conjunctivitis longer than 7 days after initial ocular symptoms. * corneal ulcer, endophthalmitis, or any other confounding infection of the eye. * patients taking ocular anti-inflammatory medications on a chronic basis. * active herpes ocular infection. * known or suspected pregnancy. * known allergy to pvp-i. * known allergy to dexamethasone. * patients with a history of elevation in intraocular pressure as a result of steroid use ("steroid responders").
robotic rehabilitation of upper limb in pd

Conditions: Parkinson Disease

Summary: it has been shown that robot-assisted therapy may be considered an effective and reliable method for the delivery of highly repetitive training useful to boost neuroplasticity. thus, an early, intensive, repetitive and task oriented training could be an ideal strategy to facilitate relearning of motor function and to improve motor function. the armeo-s® is a specific upper limb electromedical device mainly used to reduce spasticity and improve muscle force. to date robotic upper limb training has been applied only in patiebts with brain injury and spinal cord lesions. aim of the study is to evaluate the efficacy of armeo-s in improving upper limb agility in a sample of pd patients, as compared to traditional physiotherapy.


Eligibility criteria:
inclusion criteria: * idiopathic pd diagnosed according to the uk brain bank criteria * hoehn-yahr stage 2- 3 * mmse score ≥ 23 exclusion criteria: * severe dyskinesia * on-off motor fluctuations * history of stereotaxic brain surgery for pd; * changes in dopamine therapy dose in any time within 3 months prior to baseline; * any other medical that may compromise the patient's participation in this study such as history of ostheoarthritis or neuropathies.
lvef prediction during acs using ai algorithm applied on coronary angiogram videos

Conditions: Acute Coronary Syndrome; Left Ventricular Dysfunction

Summary: left ventricular ejection fraction (lvef) is one of the strongest predictors of mortality and morbidity in patients with acute coronary syndrome (acs). transthoracic echocardiography (tte) remains the gold standard for lvef measurement. currently, lvef can be estimated at the time of the coronary angiogram but requires a ventriculography. this latter is performed at the price of an increased amount of contrast media injected and puts the patients at risk for mechanical complications, ventricular arrhythmia or atrio-ventricular blocks. artificial intelligence (ai) has previously been shown to be an accurate method for determining lvef using different data sources. fur the purpose of this study, we aim at validating prospectively an ai algorithm, called cathef, for the prediction of real-time lvef (ai-lvef) compared to tte-lvef and ventriculography in patients undergoing coronary angiogram for acs.


Eligibility criteria:
inclusion criteria: * informed consent signed by the participant * acute coronary syndrome * creatinine clearance ≥30 ml/min/m2 according to mdrd exclusion criteria: * creatinine clearance \<30 ml/min/m2 according to mdrd * no indication to perform tte in the 7 days following coronary angiogram * right bundle branch block * suspected or confirmed left ventricular thrombus * suspected or confirmed aortic dissection * ventriculography not feasible * no left coronary system angiogram

Keywords: acute coronary syndrome; coronary angiogram; left ventricular ejection fraction; ventriculography; artificial intelligence
lantustitr: insulin glargine in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the rationale of the study is to determine: * the first dose and the titration of basal insulin * the exact daily time administration of basal insulin in poorly controlled type ii diabetic patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea) * bmi \>25 kg/m2 , \<30 kg/m2 * hba1c value \>7.0%, \<9.0% within one month exclusion criteria: * type 1 diabetes mellitus * known malignancy * drug or alcohol abuse * severe liver disease * renal failure (se creatinine \> 150 micro mol/l) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
application of ectoin containing lozenges (eht02) in patients with acute, viral pharyngitis.

Conditions: Acute Viral Pharyngitis

Summary: the goal of this non-interventional study is to investigate the safety, efficacy and tolerability of ectoin lozenges honey lemon (eht02) compared to lozenges containing hyaluronic acid and islandic moss in the treatment of acute viral pharyngitis.

the current non-interventional study aims to investigate the efficacy and tolerability of ectoin lozenges honey lemon in patients suffering from acute viral pharyngitis. participants receive treatments as part of routine medical care, and participants can choose one of two treatment options: a) ectoin lozenges honey lemon or b) lozenges containing hyaluronic acid and icelandic moss. efficacy will be studied by documentation of the following symptoms: * pain on swallowing * hoarseness * urge to cough * dry mouth and throat * redness of oropharynx and larynx * sore throat * impairment of free breathing * general feeling of illness in parallel, participating patients will document their symptoms over the entire study duration in patient diaries. the observation takes place over a period of seven days.

Eligibility criteria:
inclusion criteria: * patients with acute viral pharyngitis exclusion criteria: * patients with known intolerance to one of the substances used * pregnancy * surgical procedures in the mouth and throat region prior to the study * bacterial pharyngitis * symptoms in the throat since more than 5 days * contraindications according to the instructions for use

Keywords: non-interventional study ectoin lozenges pharyngitis
the effect of fat on vitamin d absorption

Conditions: Vitamin D Deficiency

Summary: the purpose of this study is to evaluate the absorption of dietary supplement of vitamin d3 (cholecalciferol), through the variation of 25 (oh) d levels, as the fat content of the meal associated with the administration of the supplement.


Eligibility criteria:
inclusion criteria: residents of the hospital clinics of porto alegre exclusion criteria: * don't drink milk * obesity * malnutrition * liver disease * kidney disease or diabetes * use of dietary supplements containing calcium and vitamin d * medications * anticonvulsants * barbiturates, or steroids. * having performed a journey the last four months to locations near the earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.

Keywords: vitamin d cholecalciferol supplementation dietary supplements dietary fats 25-hydroxyvitamin d
a study to assess the efficacy of xen-d0501 in reducing the cough frequency in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine the effectiveness of xen-d0501 over placebo in reducing the daytime cough frequency in patients with chronic obstructive pulmonary disease (copd). the effectiveness of xen-d0501 placebo in reducing capsaicin cough responses, objective 24-hour cough frequency, hourly change in cough frequency, cough severity (via visual analogue scale \[vas\]), urge to cough (via vas), global rating of change scale, clinical copd questionnaire (ccq), leicester cough questionnaire (lcq), and st george's respiratory questionnaire (sgrq-c) will be evaluated.


Eligibility criteria:
inclusion criteria: * male/female subjects aged 40 or over with copd exclusion criteria: * clinically significant medical history * abnormal laboratory results, ecgs or vital signs
drug drug interactions of aspirin and p2y12-inhibitors

Conditions: Drug Interaction Potentiation; Myocardial Infarction

Summary: study objective: to investigate potential drug-drug interactions (pharmacokinetics and pharmacodynamics) of morphine and antiplatelet drugs (aspirin, clopidogrel, prasugrel, ticagrelor)

rationale: opiates reduce the intestinal resorption of orally administered drugs such as paracetamol. because morphine is often injected to relieve pain in patients with myocardial infarction, it is of particular interest if morphine may decrease the rate of absorption of antiplatelet drugs. results of this study will provide essential information for the use of morphine and antiplatelet drugs in clinical practice, in particular in myocardial infarction.

Eligibility criteria:
inclusion criteria: * healthy volunteers ≥ 18 years of age * no intake of nsars and p2y12-inhibitors within 14 days before study entry * written informed consent exclusion criteria: * known coagulation disorders * relevant impairment of hepatic function (elevated transaminases, ≥ 2 fold) * relevant impairment of renal function * infectious diseases (hiv, hepatitis b and c) * gestation and lactation * clinically relevant abnormal laboratory values * use of medication during 2 weeks before the start of the study, which may affect the validity of the study * general contraindications for aspirin (resp. clopidogrel, prasugrel, ticagrelor) and morphine
dutch cholecystitis snapshot study

Conditions: Cholecystitis; Cholecystitis; Gallstone; Cholecystitis; Choledocholithiasis

Summary: background: cholecystitis is treated by in various types of hospitals by different specialists, and treatment strategy is influenced by logistical and medical reasons and personal preference. this may significantly impact hospital stay and other outcomes. purpose: to determine the variation in treatment of cholecystitis in the netherlands and its impact on outcome. methods: nation-wide cohort study of all patients diagnosed and treated for cholecystitis during a 6 month period. the primary outcome will be the proportion of patients with an acute cholecystitis in which the guideline is followed. this group will be compared to those in which the guideline is not followed, focussing on total hospital stay and complications. secondary aims are to determine: factors related to guideline compliance; the best method of cystic duct closure; the best treatment strategy for a \>7-day existing cholecystitis; factors predictive for concomitant common bile duct stones; strategies following gallbladder drainage. multivariable analysis and propensity score matching will be used when appropriate for the etiological study aims. the tripod guideline for prediction modelling will be used for the predictive study aims. hospitals will receive their own results, set out against the national average and best practices, thereafter subsequent changes in hospital practice will be recorded. conclusion: this study will determine the variation in treatment of cholecystitis in the netherlands and its impact on clinical outcome. its results will serve as an important incentive to create optimal, uniform cholecystitis treatment in the netherlands.


Eligibility criteria:
all patients \>18 years with a calculous cholecystitis as primary reason for their hospital admittance. location of diagnosis may the emergency department, the ward during admittance for diagnostics, or during diagnostic laparoscopy. cholecystitis is defined according to the tg18 diagnostic criteria for a definitive diagnosis of cholecystitis: a. local signs of inflammation (murphy's sign and or ruq mass/pain/tenderness) + b. systemic signs of inflammation (fever, elevated crp and/or elevated wbc count) + c. imaging findings characteristic of acute cholecystitis. patients with a suspected diagnosis (one item in a + one item in b + c), of which the diagnosis is confirmed by peroperative findings, are also included. patients will be identified by a local study investigator, e.g. a surgeon or surgeon in training.