Kornimate/medical-research-clean huggingface dataset:
ivabradine for prevention of myocardial injury after noncardiac surgery trial (prevent-mins)

Conditions: Myocardial Injury After Noncardiac Surgery (MINS); Myocardial Ischemia

Summary: this study is a multicentre, randomized controlled trial of ivabradine versus placebo.

the prevent-mins study is a 2,500 patient multicentre, superiority randomized controlled trial of ivabradine versus placebo. the primary objective of the trial is to determine the impact of ivabradine versus placebo on the risk of mins in patients with or at risk of atherosclerotic disease who are followed for 30 days after noncardiac surgery.

Eligibility criteria:
inclusion criteria: 1. undergoing noncardiac surgery 2. ≥45 years of age 3. expected to require at least an overnight hospital admission after surgery 4. provide written informed consent to participate in the prevent-mins trial, and 5. fulfill ≥1 of the following 5 criteria (a-e): a. history of coronary artery disease b. history of peripheral arterial disease c. history of stroke d. undergoing major vascular surgery, or e. any 3 of 9 risk criteria: i. undergoing major surgery ii. history of congestive heart failure iii. history of a transient ischaemic attack iv. diabetes and currently taking an oral hypoglycemic agent or insulin v. age ≥70 years vi. history of hypertension vii. serum creatinine \>175 µmol/l (\>2.0 mg/dl) viii. history of smoking within 2 years of surgery ix. undergoing emergent/urgent surgery exclusion criteria: 1. conduction abnormalities: a. non-sinus rhythm on ecg b. sinoatrial or av (2nd and 3d degree) blocks c. sick sinus syndrome d. long qt syndrome e. pacemaker dependent 2. transplanted heart (or on waiting list) 3. use of a selected class i or iii antiarrhythmic drug (quinidine, disopyramide, sotalol, ibutilide, amiodarone) or diltiazem/verapamil 4. resting heart rate \<65 beats per minute on the day of surgery 5. systolic blood pressure \<90 mmhg on the day of surgery 6. acute decompensated heart failure, cardiogenic shock, acute myocarditis 7. acute coronary syndrome within 2 months before surgery; 8. stroke or transient cerebral ischaemia within 1 month before surgery 9. known severe liver or kidney disease (mdrd creatinine clearance \<15 ml/min) 10. inability to tolerate oral intake 11. recent use of ivabradine (\<1 month) 12. known allergy or hypersensitivity to ivabradine 13. low-risk surgical procedure based on individual physician's judgment 14. investigator considers the patient unreliable regarding requirement for study compliance 15. women of childbearing potential who are not taking effective contraception, pregnant or breast-feeding 16. previously enrolled in the prevent-mins study

Keywords: myocardial ischemia randomized controlled trial blinded noncardiac surgery cardiovascular events myocardial injury after non-cardiac surgery perioperative myocardial injury perioperative myocardial infarction perioperative medicine heart rate ivabradine cardiovascular diseases troponin perioperative care physiological effects of drugs cardiovascular agents cardiac chronotropy heart rate control
sleep apnea-hypopnea syndrome and the pathogenesis of obesity

Conditions: Sleep Apnea; Obesity

Summary: the hypothesis of the study is the following: patients with sleep apnea-hypopnea syndrome have different pattern in the secretion of hormones. the chronic sleep disorganization that suffer patients with sleep apnea-hypopnea syndrome (sahs) may affect the central mechanisms that regulate nutritive behavior and energetic balance, causing an alteration in the secretion of hormones that favour the appearance and/or development of obesity.

objectives: to compare the plasmatic profiles of different hormones and neuropeptides, related with weight control, metabolism and intake in patients with sahs as well as in selected control subjects according to weight. design: multicenter, prospective and controlled study. 40 patients with sahs will be included as well as 40 control subjects. methods: to all subjects included in the study, the following procedures will be performed: 1. medical history; 2. anthropometric variables (height, weight, body mass index; 3. somnolence evaluation using the epworth scale; 4. conventional polysomnography (psg); 5. determination every four hours during a 24 hours period of the levels of leptin adiponectin, resistin, insulin, pcr, etc. 6. conventional biologic evaluation; 7. patients will be re-evaluated after three months of treatment with cpap.

Eligibility criteria:
inclusion criteria: * apnea-hypopnea index \> 15 * body mass index \ 30 kg/m2 exclusion criteria: * presence of any chronic disease * drug addiction and/or alcoholism * refusal to sign informed consent

Keywords: sleep apnea obesity neuropeptides hormones
cannabidiol treatment in patients with early psychosis

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: cannabidiol (cbd) is a component of herbal cannabis that is present in varying concentrations in cannabis extracts. cbd has been shown to produce central effects including hypnotic, anticonvulsive, anxiolytic and neuroprotective effects.the investigators hypothesize that treatment with cbd will result in: 1) improvement evidenced by a reduction in scores on the positive and negative syndrome scale for schizophrenia (panss), 2) improvement evidenced by a reduction in the clinical global impression of severity scale (cgi); secondary hypothesis: 1) greater improvement in functioning as measured on the "patient assessment of own functioning inventory: (paofi) and the quality of life scale (qls) in this 2 period cross over design, subjects will be randomized in a 1:1 ratio to receive either: order 1: cbd (period 1) followed by placebo (period 2) or order 2: placebo (period 1) followed by cbd (period 2) under double-blind conditions. the 2 study periods will be separated by a washout of at least 2 weeks. during each period subjects will receive study medications (cbd \[total 800mg/day\] or placebo) for a period of 4 weeks.


Eligibility criteria:
inclusion criteria: * male or female * primary psychotic disorder * ages 18-65 (inclusive) exclusion criteria: * current significant medical condition or other comorbidities * current substance depdendence * women who are pregnant or breastfeeding
study of palliative radiation therapy vs. no palliative radiation therapy for patients with high risk bone metastases that are not causing significant pain

Conditions: Metastatic Solid Tumors of Metastatic Disease

Summary: the purpose of the study is to compare the outcome of patients who receive standard treatment versus those who receive preventative radiation and then standard treatment.


Eligibility criteria:
inclusion criteria: * histologically confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on imaging. * has high risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). high risks metastases are defined as: 1. bulkiest sites of osseous disease ≥ 2cm, 2. disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints 3. disease in long bones with1/3-2/3 cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) 4. disease in junctional spine (c7-t1, t12-l1, l5-s1) and/or disease with posterior element involvement. * ecog performance status 0 - 2. * age ≥ 18 years. * able to provide informed consent. * patients at reproductive potential must agree to practice an effective contraceptive method. women of childbearing potential must not be pregnant or lactating. exclusion criteria: * previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. * serious medical co-morbidities precluding radiotherapy. * pregnant or lactating women. * target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture. * leptomeningeal disease. * malignant pleural effusion. * absolute neutrophil count (anc) \<1.0 k/mcl and platelet count \<50 k/mcl at time of enrollment. * patients whose entry to the trial will cause unacceptable clinical delays in their planned management.

Keywords: palliative radiation 18-196
magnevist (sh l 451a) intra-individual dose comparison study in patients with brain metastasis

Conditions: Brain Neoplasms

Summary: to verify the number of metastatic brain tumors detected in contrast-enhanced mri, which is the primary variable, increases after an additional dose of magnevist (sh l 451a) comparing images after an initial dose (0.1 mmol/kg) with those after an additional dose (0.1 mmol/kg, a total dose of 0.2 mmol/kg) intra-individually in patients with metastatic brain tumors. safety was also to be assessed.


Eligibility criteria:
inclusion criteria: * patients who are confirmed to have 1-5 metastatic brain tumor by the latest contrast-enhanced cerebral ct or contrast-enhanced cerebral mri, and the lesion(s) have not been treated by surgery or by stereotactic radiosurgery. exclusion criteria: * patients who are scheduled to receive another contrast medium for mri (except for oral agents) or iodine contrast medium (except for oral agents), or to undergo surgical procedures during the period from the day before administration of magnevist (sh l 451a) to examination of safety on the following day. * patients who underwent or are scheduled to undergo radiotherapy during the period from 14 days before administration of magnevist (sh l 451a) to examination of safety on the following day. * patients who were treated or are scheduled to be treated with anti-cancer agents (except for treatment only by the oral agents of the fixed dose continuously from 28 days or more before administration of magnevist (sh l 451a)) during the period from 28 days before administration of magnevist (sh l 451a) to examination of safety on the following day.

Keywords: detection of brain metastasis by mri magnevist brain metastasis meglumine gadopentetate
pharmacokinetics (pk) study of epinephrine inhalation aerosol in healthy volunteers

Conditions: Asthma

Summary: this study examines the pharmacokinetic profile of armstrong's proposed epinephrine inhalation aerosol usp, an hfa-mdi (e004), in healthy male and female adult volunteers. safety of e004 will also be evaluated, under augmented dose conditions.

this study is a randomized, evaluator-blind, single dose, three-arm, crossover, pk study, to be conducted in \~18 healthy, male and female, adult volunteers. pk will be studied at two dose strengths (arm t1 and arm t2). a currently marketed, non-labeled, epinephrine cfc-mdi will be used as a reference control (arm c). * at the screening visit and the beginning of each study visit, each subject will be trained on the correct self-administration of mdi. the following three randomized treatments will be self-administered, at three study visits: * treatment t1: ten (10) inhalations of the low dose e004(125 mcg/inhalation), totaling 1.25 mg of epinephrine; * treatment t2: ten (10) inhalations of the high dose e004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine; * treatment c: ten (10) inhalations of epinephrine cfc-mdi (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent). * pk blood samples will be taken from a vein at scheduled time points. * safety parameters and adverse drug events, if any, will be monitored and documented at each study visit. an end-of-study (eos) safety evaluation will be conducted.

Eligibility criteria:
inclusion criteria: * generally healthy, male and female adults, 18-30 yrs of age at screening; * having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion; * women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; * having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol. * other criteria apply. exclusion criteria: * a recent or significant smoking history; * use of prohibited drugs or failure to observe the drug washout restrictions; * having been on other investigational drug/device studies in the last 30 days prior to screening. * other criteria apply

Keywords: asthma pharmacokinetics epinephrine bronchodilator metered dose inhaler
a study of mm-111 and paclitaxel with trastuzumab in patients her2 positive carcinomas of the distal esophagus, gastroesophageal (ge) junction and stomach

Conditions: HER-2 Gene Amplification; Esophagus Cancer; Gastroesophageal Junction Cancer; Stomach Cancer

Summary: to determine whether the combination of mm-111 plus paclitaxel and trastuzumab is more effective than paclitaxel and trastuzumab alone

this is a randomized, open label, phase 2 study of mm-111 and paclitaxel withtrastuzumab in patients with her2 positive carcinomas of the distal esophagus, gastroesophageal (ge) junction and stomach who have failed front line metastatic or locally advanced therapy. approximately 120 patients will be randomized in a 1:1 ratio between the experimental and comparator arms.

Eligibility criteria:
inclusion criteria: * patients must have documentation of histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the distal esophagus, ge junction or stomach * patients must have documentation of histologically or cytologically confirmed her2 expression * patients must be ≥18 years of age * patients must have ecog ps of 0, 1, or 2 * patients must have adequate hematologic status, renal and hepatic function exclusion criteria: * patients with known hypersensitivity to any of the components of mm-111 * patients with a known history of hypersensitivity to paclitaxel or other drugs formulated in cremophor® el * patients with a known history of hypersensitivity to trastuzumab or any of its components (group 1 patients only) * patients with an active infection or with an unexplained fever \>38.5°c

Keywords: her-2 gene amplification esophagus cancer gastroesophageal junction cancer stomach cancer her2 positive her2+ esophageal cancer metastatic
determination of optimum age for dxa screening for osteoporosis in hiv - the probono 1 study

Conditions: Osteoporosis; Fractures; HIV Infection

Summary: the purpose of this study is to determine the bone mineral density in male and female patients with hiv infection according to age groups. this will enable a practical approach to screening for osteoporosis and the management and prevention of fragility fractures in people with hiv. in addition, all risk factors commonly associated with fragility fractures and osteoporosis are collected, as is hiv drug history. hence, as secondary outcomes, the associations with reduced bone mineral density can be ascertained.


Eligibility criteria:
inclusion criteria: * 18 years or above not pregnant able to comply with study observations and procedures able to give fully informed consent exclusion criteria: * pregnant less than 18 years of age unable to comply with study procedures

Keywords: hiv bone mineral density osteoporosis vitamin d fractures
prevention of intrauterine adhesions after hysteroscopic metroplasty with autocross-linked hyaluronic acid gel

Conditions: Intrauterine Adhesions; Septate Uterus

Summary: the septate uterus is the most common structural uterine anomaly. it results from failure of the partition between the two fused müllerian ducts to resorb;it is associated with the highest incidence of reproductive failure and with first- and second-trimester pregnancy loss and infertility. hysteroscopic division of the uterine septum is performed using microscissors, electrosurgery, or laser. several studies shown significant improvement in pregnancy outcome after hysteroscopic metroplasty. purpose of this study is to verify the effectiveness of 5 ml, instead of 10 ml, of autocross-linked hyaluronic acid gel in the prevention of the formation of intrauterine adhesions, through second look office hysteroscopy after three months.


Eligibility criteria:
inclusion criteria: * uterine septum * history of ≥1 miscarriage or infertility; * desire to have children in the future exclusion criteria: * pregnancy; * menopause; * precancerous state or malignancy of the reproductive organs; * benign lesions in the myometrium of the uterine fundus (myomas or adenomyosis) * lesions distorting the uterine cavity (submucosal myomas or intrauterine adhesions) on ultrasonography; * withdrawal of patient consent; * rare complex uterine congenital anomalies without an asrm classification such as uterine septum with double cervix ; * presence of external intercornual cleft; * incomplete (internal fundal indentation 10 mm) or non-standardized septum resection (internal fundal indentation ,10 mm and uterine myometrial thickness .10 mm at the fundus), confirmed intraoperatively * excessive fundal incision (uterine myometrial thickness ,6 mm at the fundus confirmed intraoperatively)
the efficacy of nifedipine in the management of preterm labor

Conditions: Preterm Labor; Preterm Birth; Preterm Labor Without Delivery; Preterm Labor With Preterm Delivery in Third Trimester; Calcium-Channel Blockers Toxicity; Side Effect of Drug

Summary: preterm labor is one of the problems of obstetrics, and is one of the leading cause of neonatal morbidity and mortality. the incidence of preterm birth is around 7 to 9 %. the preterm baby is prone to respiratory, renal, neurologic and gastrointestinal problems. the correct diagnosis should be followed by the early administration of the most effective tocolytic agent with least side effects for both mother and fetus. nifedipine, a calcium channel blocker, has gained a world-wide popularity recently since it has the least side-effects on both mother and fetus. in the present study, we aimed to evaluate the success rate of tocolytic agent 'nifedipine' on the spontaneous preterm labor of singeton pregnant women with intact amnionic membrane.

preterm birth is the main reason of perinatal morbidity and mortality. the main management method of this important problem is to prolong the pregnancy period and to use corticosteroids to prevent fetal pulmonary distress. the most widely studied tocolytic agents, ritodrin, salbutamol and terbutaline are all betamimetics, and they are shown to prolong birth labor till 7 days and do not have any effct on the fetal mortality. however, their maternal side-effects are inevitable and can be mortal. they cause tachycardia, hypotension and some biochemical disturbances. furthermore, maternal death is possible due to pulmonary edema. these adrenergic agonists are the first line tocolytics, but calcium canal blockers are becoming more popular since they have less side effects and comparable efficacy. calcium canal blockers are nonspecific smooth muscle relaxants used in adult hypertension treatment. their tocolytic effect depends on their inhibition of calcium ions into the myometrial cells. in vitro studies have shown that they have strong relaxant effects on human myometrium. in the present study, our aim is to investigate the effects of nifedipine in our clinic in a period between 2002 and 2005, when it was first used in our clinic as the sıngle tocolytic agent. its success in preventing preterm labor and its complications in our earlier practice will be noted and this retrospective study will guide us in its current usage, dosages and side-effects.

Eligibility criteria:
inclusion criteria: * ingleton pregnant women with spontaneous preterm labor at their 23-37 weeks. exclusion criteria: * normal pregnant women * pregnent women before 23 weeks of gestation * pregant women between 23 and 37 weeks of gestation, but with preterm early membrane rupture, chorioamnionitis, preterm labor without cervical change, multiple pregnancy, hypertension, intrauterine growth retardation, fetal anomaly, oligoanhidramniosis, placenta previa, decolman placentaand intrauterine fetal death

Keywords: nifedipine tocolytics
pravastatin and protease inhibitors in hiv-infected patients

Conditions: HIV Infection; Hypercholesterolemia

Summary: to assess the use of pravastatin in hypercholesterolemic hiv-infected patients treated with protease inhibitors in a randomised double blind study.

background. highly active antiretroviral therapy including protease inhibitors is associated with elevated plasma lipid levels. design. randomized double-blind, multicentric. intervention. pravastatin versus placebo for 12 weeks. eligibility criteria. positive for anti-vih antibodies, stable antiretroviral therapy including at least one pi for \>= 3 months, plasma hiv-rna level of \ = 3 months before randomization, total cholesterol \>= 5.5 mmol/l with ldl-cholesterol \>= 3.4 mmol/l on fasting status after three months of standardized dietary advice, written informed consent outcomes. hiv rna at 12 weeks

Eligibility criteria:
inclusion criteria: * confirmed hiv-1 infection (elisa confirmed by western-blot test) ; * age above 18 years * stable antiretroviral therapy including at least one pi for \>= 3 months, * plasma hiv-rna level of \ = 3 months before randomization, * total cholesterol \> = 5.5 mmol/l with ldl-cholesterol \> = 3.4 mmol/l on fasting status after three months of standardized dietary advice, * signed informed consent exclusion criteria: * current aids event or infectious disease * tumoral, inflammatory, muscle diseases; kidney or hepatic failure * psychiatric conditions * biological elevated muscular enzymes * chronic alcohol consumption * pregnancy

Keywords: hiv, protease inhibitors pravastatin treatment experienced
effect of background noise on sleep quality

Conditions: Sleep Onset Insomnia

Summary: insufficient and low-quality sleep is a major public health problem that has been linked to motor vehicle crashes, industrial disasters, and medical and other occupational errors. persons experiencing sleep insufficiency are also more likely to suffer from chronic diseases such as hypertension, diabetes, depression, and obesity, as well as from cancer, increased mortality, and reduced quality of life and productivity. the number of people using sleep-inducing drugs to increase or improve sleep is steadily increasing in the last few decades; however, the side effects of these therapies often outweigh the benefits. a few small trials and anecdotal findings suggest that continuous background (pink or white) noise overnight can improve sleep quality, increase acoustic arousal threshold, and reduce sleep onset latency. in an attempt to find new, alternative solutions to increase sleep quality in people suffering from insomnia, the investigators would like to test the effect of surrounding filtered white noise on sleep onset latency and subjective sleep quality in healthy subjects.


Eligibility criteria:
inclusion criteria: * age between 21 and 60 exclusion criteria: * any sleep disorder * use of hypnotics

Keywords: sleep onset latency sleep quality insomnia