Kornimate/medical-research-clean huggingface dataset:
comparing gabapentin and lorazepam for treating alcohol withdrawal

Conditions: Alcoholism

Summary: this study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. gabapentin (neurontin) will be compared to a standard benzodiazepine, lorazepam (ativan), for its effectiveness in treating alcohol withdrawal.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome. * subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days). * have a clinical withdrawal assessment prior to study. * must be medically acceptable for study treatment. considerations include no past or present physical disorder that is likely to deteriorate during participation. no ecg abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment. * able to read, write, and speak english. * have a negative urine drug screen for benzodiazepines or other sedative hypnotics, opiates, and stimulates prior to entering the study. exclusion criteria: * current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence). * use of pharmacological agents within the last 14 days that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome. * history of alcohol withdrawal seizures, epilepsy or delirium tremens. * diagnosis of schizophrenia, bipolar disorder or dementia. * liver function tests higher than normal. * history of hepatic encephalopathy, jaundice, ascites, diabetes, or renal disease. * females who are pregnant or nursing. * subjects with known sensitivity of previous adverse reaction to gabapentin, lorazepam, or other benzodiazepines. * history of severe gi disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of gi bleeding. * unable to provide an informed consent.
influenza vaccination digital interventions for people living with diabetes

Conditions: Diabetes

Summary: the overall objective of this prospective randomized controlled study is to assess and quantify the impact of digital interventions to increase vaccination rates and vaccination-related outcomes in a connected population with self-reported diabetes. the digital intervention will be delivered via a campaign sent to participants, with interventions varying with each study arm. participants will be blinded to study participation status.


Eligibility criteria:
inclusion criteria: * at least 18 years old * lives in the u.s. exclusion criteria: * \< 18 years old * does not live in the u.s.
today genetics study

Conditions: Type 2 Diabetes

Summary: the today study group has prepared a protocol with the primary objective of collecting blood and phenotypic information to be used to explore relationships between candidate genes and type 2 diabetes (t2d), as well as obesity, insulin resistance, and cardiovascular complications of insulin resistance. participation in the genetics study includes a blood draw for analysis of diabetes type and dna extraction, as well as collection of basic family and medical history. appropriate informed consent and assent are obtained from all participants to extract dna and send blood, genetic material, and medical history to the central repository of the national institute of diabetes and digestive and kidney diseases (niddk) of the national institutes of health (nih). the data are kept indefinitely by the central repository. the niddk will issue requests for proposals (rfp) throughout the scientific community for research that may help in the development of new diagnostic tests, new treatments, and new ways to prevent diabetes and other related comorbidities.


Eligibility criteria:
inclusion criteria: * diabetes by ada criteria (laboratory determinations of fasting glucose ≥ 126 mg/dl, random glucose ≥ 200 mg/dl, or two-hour oral glucose tolerance test (ogtt) glucose ≥ 200 mg/dl) documented and confirmed in medical record or a laboratory determination of hba1c ≥ 7%. for asymptomatic patients diagnosed with diabetes with a normal fasting glucose but an elevated two-hour glucose during an ogtt, the hba1c must be ≥ 6%. * bmi ≥ 85th percentile documented at time of diagnosis or at screening. * age \< 18 at time of diagnosis. * signed informed consent and assent forms as appropriate. exclusion criteria: * genetic syndrome or disorder known to affect glucose tolerance other than diabetes. * patient on medication known to affect glucose tolerance, insulin sensitivity or secretion within 60 days of the time of diagnosis. if diagnosis is confirmed after the patient has been off the medication for 60 days, the patient may be included. exclusionary medications include but are not limited to 1. inhaled steroids at dose above 1000 mcg daily fluticasone equivalent, 2. oral glucocorticoids, 3. antirejection or chemotherapy agents (e.g., tacrolimus, l-asparaginase), 4. atypical antipsychotics.

Keywords: genetics, pediatrics
tdap vaccine safety for plasma donors

Conditions: Tetanus

Summary: this is a prospective, open label, single-arm, multi-center, phase 1 study measuring the safety and tetanus antibody responses to tdap vaccine administered to plasma donors every 3 months ±1 week for 12 months (5 vaccinations) with a 6 month follow-up after the last vaccination. after obtaining informed consent and screening for eligibility including plasmapheresis donor eligibility, subjects will have other baseline assessments performed and if eligible, will receive the scheduled vaccinations, will be assessed for adverse events (aes) and have plasma samples collected for antibody titers each month thereafter for 11 months, and then at 1 and 6 months after the last vaccination. as these subjects are participating in a standard donor plasmapheresis donor program, assessments for donor eligibility and routine plasmapheresis will be performed; however, only the data specifically required to meet the objectives of this study will be collected.


Eligibility criteria:
inclusion criteria: * male or female ages 18 to 63 years * females of childbearing potential who agree to employ adequate birth control measures during the study * signed the informed consent form (icf) * met all of the criteria required by gcam to be a normal source plasma donor * subject is not participating in any other immunization program exclusion criteria: * subject is pregnant * subject has a condition or abnormality that in the opinion of the investigator would compromise the safety of the subject or the quality of the data * subject has repeated reactions or hypersensitivity to components in the vaccine (e.g., thimerosal, latex, etc.) * subject has history of a severe reaction to any immunization * subject has a history of guillain-barré syndrome * the investigator concludes that the anticipated vaccination site (deltoid area) is not suitable for ae assessment
nitric oxide-mediated cardioprotection during cardiac surgery with cardiopulmonary bypass

Conditions: Coronary Artery Disease; Coronary Artery Bypass; Cardiopulmonary Bypass; Nitric Oxide; Reperfusion Injury, Myocardial

Summary: this prospective randomized study elucidates the effects of exogenous nitric oxide delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery with cardiopulmonary bypass.

the aim of this study is to investigate the effects of exogenous nitric oxide (no) delivered to the extracorporeal circulation circuit for cardioprotection against ischemia-reperfusion injury during coronary artery bypass graft surgery (cabg) with cardiopulmonary bypass (cpb). a total of 60 patients with ischemic heart disease referred for cabg with cpb are included in prospective randomized study. patients are randomized to receive standard treatment or surgery based on modified cpb protocol. according to modified protocol, 40-ppm no is supplied to the cpb circuit during cabg. the primary endpoints are changes in cardiac troponin i (ctni) levels at 6, 24, and 48 hours after surgery compared with baseline. the secondary end points are the changes in the levels of creatine kinase-muscle/brain (ck-mb) compared with baseline and vasoactive inotropic score (vis) at 6, 24, and 48 hours. no supplied to the cpb circuit exertes cardioprotective effect. changes in ctni, ck-mb, and vis are considered indictors of the presence or absence of cardioprotective action of no supplied to the cpb circuit.

Eligibility criteria:
inclusion criteria: * coronary artery disease requiring coronary artery bypass grafting with the cardiopulmonary bypass. exclusion criteria: * non-elective surgery, age over 70 years, left ventricular ejection fraction less than 35%, history of myocardial infarction within three months prior to surgery, chronic atrial fibrillation, diabetes mellitus, and the elevated levels of cardiac specific markers within 12 h prior to the intervention.

Keywords: cardioprotection ischemia-reperfusion injury nitric oxide cardiopulmonary bypass coronary artery bypass grafting
confirming the sitaxsentan dose in patients undergoing heart surgery

Conditions: Cardiac Surgery Subjects; Subjects Undergoing CABG and/or Cardiac Valve Replacement

Summary: this is a multi-center, randomized study of sitaxsentan administered intravenously to subjects who are undergoing elective cabg, cardiac valve replacement, or combined cabg and cardiac valve replacement procedures that require cpb.


Eligibility criteria:
inclusion criteria: * has been identified for coronary artery bypass grafting (cabg), aortic and/or mitral valve replacement, or combined cabg and cardiac valve replacement procedures that require cardiopulmonary bypass (cpb). exclusion criteria: * requires an emergent or "emergency" cabg and/or cardiac valve replacement.

Keywords: multi-center placebo-controlled randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-cpb
examining feasibility, acceptability, and sustainability of a novel personalized smartphone intervention for suicide - open trial

Conditions: Suicide and Self-harm; Suicide; Suicide, Attempted; Suicidal Ideation

Summary: the primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the mobile application to prevent suicide (maps), and to establish feasibility, acceptability, safety, and estimate key parameters for secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).


Eligibility criteria:
inclusion criteria: * presence of suicidal ideation and/or suicidal behavior in the past month * between the ages of 18 and 70 * able to read, write, and understand english well enough to complete study procedures * owns a smartphone exclusion criteria: * current psychotic or manic symptoms severe enough to interfere with completion of study procedures
benzydamine hcl for postoperative sore throat

Conditions: For Intervention

Summary: to evaluate the analgesic effect of benzydamine hydrochloride dripping on the endotracheal tube cuff for postoperative sore throat.

the investigators will assign patients into either the benzydamine hydrochloride or the control group. the whole ett cuff will be either dripped with 3 ml (4.5 mg) of benzydamine hydrochloride or nothing 5 minutes prior to anesthesia induction. the incidence and severity of post at 0, 2, 4, 6, 12 and 24 hours postoperatively will be assessed. the potential adverse effects of benzydamine hydrochloride (throat numbness, throat burning sensation, dry mouth and thirst) will also be evaluated.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 years * asa status i-ii * mallampati grade i-ii * duration of surgery less than 4 hours * patients placed in the supine position exclusion criteria: * undergoing oral, cervical spine or thyroid surgery * more than one attempt of ett intubation or intubated with a technique of rapid sequence induction with cricoid pressure * insertion of nasogastric/orogastric tube or esophageal stethoscope * complaint of sore throat or hoarseness * presence of upper respiratory tract infection within 7 days prior to the operation * gastroesophageal reflux * known allergy to benzydamine hydrochloride or other nonsteroidal anti-inflammatory drugs (nsaids)

Keywords: benzydamine hcl endotracheal tube postoperative sore throat
cardiac output autonomic stimulation therapy for heart failure (coast-hf) - human neurocatheter study

Conditions: Cardiac Output, Low

Summary: a single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

a single-center feasibility study performed in patients undergoing a planned cardiac catheterization. this study investigated the feasibility of the neurotronik cans therapy™ system to improve acute hemodynamics. purpose-built stimulation catheters were percutaneously inserted into an upper venous structure near the heart via right femoral vein and or left subclavian vein access using standard introducers and techniques. subjects were instrumented with left ventricular and femoral artery catheters for pressure measurement and stimulated for approximately 60 minutes. baseline hemodynamic measures were collected before stimulation and compared to measured values during stimulation. following completion of the protocol, all in-dwelling equipment and catheters were removed.

Eligibility criteria:
inclusion criteria: * stable symptomatic heart failure - new york heart association class ii or iii * normal sinus rhythm exclusion criteria: * unable to gain arterial or venous access using standard percutaneous techniques * new york heart association class iv * patient taking amiodarone or other anti-arrhythmic therapy * patients with implanted pacemaker, icd, or crt device * patients who had cabg, pci or enzyme-positive mi within prior month * patients with pre-existing carotid artery or cerebral disease * patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis) * patients who have been hospitalized for heart failure and who required the use of heart failure iv therapy within 30 days before enrollment (measured from release) * patients with current or prior vagal nerve simulator * patients with renal failure * patients with hepatic failure * patients with narrow angle glaucoma * patients who are pregnant * patients with a life expectancy \< 12 months per physician judgment * patients with allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products

Keywords: electrical stimulation therapy parasympathetic nervous system sympathetic fibers post ganglionic congestive heart failure heart failure
prognostic factors in prostate cancer for patients treated by watchful waiting

Conditions: Prostate Cancer

Summary: the trans-atlantic prostate group (tapg) was established to examine the hypothesis that through a detailed retrospective analysis of outcome in a group of men with clinically localised prostate cancer at diagnosis, variables such as biological, pathological and clinical markers, could be identified that might accurately predict the prognosis of clinically localised prostate cancer.

in 1999, the tapg group initiated the "prognostic factors in prostate cancer for patients treated by watchful waiting" study, referred to as the tapg study. it is a retrospective population-based tissue sample study in men diagnosed with localised prostate cancer 1990-2006, inclusively. initially the cohort comprised men diagnosed with prostate cancer with transurethral resection of the prostate (turp) and needle biopsies 1990-1996, but was expanded from 2005 to include men diagnosed with prostate cancer 1990 - 2006. data was collected from six regional cancer registries and eligibility was confirmed via hospital sites, which sent the relevant tissue samples to the tapg central coordinating office (cco). selection of eligible patients for the study completed in 2010. since this year the tapg cco has been collecting cancer registration and mortality updates on the cohort members from regional cancer registries.

Eligibility criteria:
inclusion criteria: * patients must be aged less than 76 years at the time of diagnosis * patients must have had a baseline serum psa level measured before starting any treatment and within six months of diagnosis * patients must have been diagnosed between 1990 and 2006 with a clinically localized (clinical stage t1-t3, n0 or nx, mo or mx) prostate cancer, in the judgment of the treating physician * the initial diagnostic biopsy sample must be available for review. patients should have (but are not required to have) tissue blocks available for review. * there must be no evidence of metastatic disease * while data collection will include review of the reports of any imaging studies of the prostate, bones, or soft tissues, these studies are not essential * each patient should have had an adequate medical evaluation to document the status of disease for the first five years after diagnosis. follow-up should include an annual psa and digital rectal examination. records will be reviewed to seek all information about medical evaluation after the time of diagnosis. exclusion criteria: * patients older than 76 years at the time of diagnosis * patients who have not had a baseline serum psa level measured before starting any treatment * patients who do not have the initial diagnosis biopsy sample for review * patients with evidence of metastatic disease

Keywords: biomarkers pathology tissue watchful waiting active surveillance
efficacy and safety of tadalafil in subjects with erectile dysfunction caused by spinal cord injury

Conditions: Erectile Dysfunction; Spinal Cord Injuries

Summary: this is a study of the efficacy and safety of on-demand dosing of tadalafil or placebo administered for 12 weeks to men with erectile dysfunction caused by spinal cord injury.


Eligibility criteria:
inclusion criteria: * males who developed erectile dysfunction as a result of spinal cord injury. injury must have occurred 6 months before the start of the study. * at least 4 sexual intercourse attempts during the first 4 weeks of the study without medication assistance * no use of other erectile dysfunction treatment for at least 4 weeks before receiving the first dose of study drug. also cannot use any other erectile dysfunction treatment during the study. exclusion criteria: * impotence caused by other primary sexual disorders including premature ejaculation or untreated endocrine diseases such as diabetes, hypopituitarism, hypothyroidism, or hypogonadism * history of radical prostatectomy or other pelvic surgery with subsequent failure to achieve any erection and history of penile implant. * history of cardiac conditions including angina requiring certain treatment with nitrates; heart disease or coronary conditions including myocardial infarction, bypass surgery, angioplasty or stent placement for a specified time before starting the study. * significant renal problems within 6 months before starting the study. also, active liver disease including jaundice at beginning of study. * history of other central nervous system injuries, other than spinal cord injury, 6 months before starting the study.

Keywords: erectile dysfunction as a result of traumatic spinal cord injury
intraoperative radiotherapy after the resection of brain metastases

Conditions: Brain Metastases

Summary: intramet examines prospectively the effectiveness of an intraoperative radiotherapy immediate after the surgical resection of brain metastases. patients won't receive further radiation therapy of the intraoperatively treated lesion.

brain metastases occur in up to 40% of all patients diagnosed with systemic cancer. without adjuvant radiotherapy after resection of space occupying lesions local recurrence rates are high. that is why guidelines recommend a cavity boosting with x-rays. external beam radiotherapy can lower the risk of local recurrence but means longer hospitalization, prolongs the time to systemic salvage therapies and bears risks of radionecrosis and leucoencephalopathy with neurological and cognitive decline. a solution for this problem could be onetime intraoperative radiotherapy (iort) with soft x-rays to sterilize the resection cavity, which may provide both: freedom from local recurrence fast track salvage therapy initiation. intramet is a single institution, open-label, prospective, phase 2 feasibility study for intraoperative radiotherapy immediately following resection of brain metastases. 50 adult patients with resectable not dural brain metastases should be treated in surgery after tumor resection with iort with 20-30gy prescribed to the margin of the resection cavity. the highest dose tolerable to surrounding risk structures (n. opticus, brainstem) should be used. with this method, the investigators hope to show similar local control rates to postoperative external beam radiotherapy in line with guideline recommendations with less patient hospitalization and faster start of rescue therapies which could lead to a favorable overall outcome and less cognitive side effects.

Eligibility criteria:
inclusion criteria: * karnofsky performance index ≥ 50% * mri t1 gadolinium enhancing non-dural resectable lesion * informed consent * adequate birth control * frozen section confirms metastasis * adequate distance to optic nerve and brainstem exclusion criteria: * dural lesions or meningeal carcinomatosis * frozen section reveals glioma, lymphoma,small cell lung cancer or germinoma * psychiatric or social condition interfering compliance * contraindication against anesthesia, surgery, mri and/or gadolinium * pregnant or breast-feeding women

Keywords: brain metastases intraoperative radiotherapy neurosurgery
transcranial magnetic stimulation in misophonia

Conditions: Misophonia

Summary: the purpose of the project is to assess the efficacy of parietal transcranial magnetic stimulation in misophonia. n=60 participants will undergo two transcranial magnetic stimulation sessions: one inhibitory and another excitatory. during both sessions, the parietal region will be stimulated. participants will perform computerized tasks immediately before and after the stimulation, while eeg, heart rate, and skin temperature will be recorded. these recordings will be used to assess if tms can be used to improve tolerance to misophonia triggers.


Eligibility criteria:
inclusion criteria: * hypersensitive to presence of a specific sound, which may be accompanied by irritation, anger/outbursts, or fear. * must be between the ages of 18 - 55. * must be fluent in english since the study's instructions, surveys, and tasks will be in english. exclusion criteria: * axis i psychiatric condition, past or present, as defined in dsm-v. * disability or medical condition that prohibits completion of study. participants must be able to complete all study procedures to ensure optimal conditions for data analysis. * central nervous system (cns) disease, such as history of brain abnormalities (e.g., neoplasms, subarachnoid cysts), cerebrovascular disease, infectious disease (e.g., abscess), or other neurological diseases, history of head trauma (defined as loss of consciousness\>3 min), or history of seizures without a resolved etiology. cns disease and drugs that act in the peripheral or central nervous system are likely to have effects on patterns of neural activity. * recent or regular use of psychotropic medication (e.g., amitriptyline for migraines). * recent use of drugs of abuse. * presence of any mental implants in the head. * pregnant or lactating.

Keywords: misophonia transcranial magnetic stimulation crossover trial single session eeg