Kornimate/medical-research-clean huggingface dataset:
behavioral counseling for alcohol dependent smokers (nicotine patch)

Conditions: Alcoholism; Smoking

Summary: this study is to evaluate the effectiveness of a mood management intervention on abstinent alcoholic smokers with a history of major depression. the second aim is to determine the effect of smoking treatments on alcohol abstinence and to identify factors associated with smoking and alcohol outcomes (e.g., more days of abstinence). a randomized, two-group design will be used to evaluate the added benefit of mood management compared to a state-of-the-art smoking cessation treatment. treatment will consist of 8 weekly group sessions and 1, 3, 6, and 12-month follow-up.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence. * currently abstinent from alcohol and other drugs for at least 3 months. * meets criteria for history of major depression independent of alcohol use. * smoked an average of 10 or more cigarettes per day during the past month. * able to fully participate in all aspects of the study. * willing to participate in eight 2-hour treatment sessions and 12 months of followup. * willing to stop smoking and wear a nicotine patch for six consecutive weeks and refrain from participating in additional smoking interventions for the duration of treatment. exclusion criteria: * current episode of major depression (within the last 3 months) or current or lifetime history of bipolar disorder, schizophrenia or other major psychiatric disorders. * current use of antidepressant, other psychotropic medications, smokeless tobacco, nicotine replacement or other smoking cessation therapy. * any medical condition that would preclude use of the nicotine patch including current unstable angina, recent history (within 1 month) of myocardial infarction or stroke, history of severe skin allergies or evidence of severe chronic dermatoses. * currently pregnant, breast feeding or likely to become pregnant during the nicotine patch phase of the study.
photodynamic therapy for oral precursor lesions

Conditions: Leukoplakia; Lichen

Summary: pre-malignant lesions are difficult to treat. even after surgical removal they tend to re-appear. often the lesions are to large and are apparent on many sites, therefore surgical removal is not always possible. the photodynamic therapy uses a special substance, which is absorbed in cells, and thereafter activated by a defined light. the aim of this study is to compare the photodynamic therapy in potentially malignant lesions to a placebo. the investigators assume a significant better result in photodynamic therapy then treatment with a placebo.


Eligibility criteria:
inclusion criteria: * existing leukoplakia simplex sin iii (diagnostics by biopsie) * leukoplakia verrucosa without indications of malignant changes (diagnostics by biopsie) * oral lichen planus sin iii (diagnostics by biopsie) * good mouth hygiene status (tartar, surface) * correct seat of the prosthesis and/or the denture * located erosions in the oral cavity * minimum age:18 years * women at the age capable of child-bearing with an appropriate contraception exclusion criteria: * malignant changes of the mucous membrane, heavy dysplasie sin iii, carcinoma in situ - heavy vitamin deficiency * pregnancy * less than 18 * satisfying women * no tobacco abuse * satisfying therapy with local immunmodulators in lichen ruber * surgical therapy of leukoplakia indicated
prediction of adverse perinatal outcome for preeclampsia in sichuan province of china

Conditions: Preeclampsia

Summary: the purpose of this study is to build a model for the prediction of adverse perinatal outcome for preeclampsia in china


Eligibility criteria:
inclusion criteria: * admitted with preeclampsia or had developed preeclampsia after admission exclusion criteria: * admitted in spontaneous labour or had achieved any component of the maternal outcome before either fulfilling eligibility criteria or collection of predictor data
effect of osa resulting from chronic tonsillitis on pregnancy outcomes

Conditions: Obstructive Sleep Apnea; Chronic Tonsillitis; Pregnancy

Summary: this cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (osa) resulting from chronic tonsillitis on pregnancy outcomes. the hypothesis posits that chronic tonsillitis-induced osa may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.


Eligibility criteria:
inclusion criteria: * pregnant women confirmed with chronic tonsillitis by clinical diagnosis and presenting symptoms. * pregnant women with a confirmed diagnosis of osa based on polysomnography or other validated sleep monitoring techniques. * pregnant women who are willing to participate in the study and provide informed consent. exclusion criteria: * pregnant women with other respiratory or sleep disorders that may confound the diagnosis of osa. * pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes. * pregnant women who have undergone surgical treatment for chronic tonsillitis or osa during the study period. * pregnant women who refuse to participate in the study or are unable to provide informed consent.
pvac gold versus irrigated rf single tip catheter with contact force ablation of the pulmonary veins for treatment of drug refractory symptomatic paroxysmal and persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the gold force trial investigates the differences between treatment with a contact force single-tip catheter against the pvac gold multielectrode catheter in cardiac ablation procedures in patients with paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: 1. history of symptomatic paroxysmal atrial fibrillation defined as: * self-terminating af with episodes lasting no more than seven consecutive days before spontaneous conversion back to sinus rhythm * documentation of one or more events with paf tracings by ecg, event recordings, pacemaker strips or monitor rhythm strips within the past year * af symptoms defined as the manifestation of any of the following: * palpitations * fatigue * exertional dyspnea * effort intolerance 2. age between 18 and 70 willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study exclusion criteria: 1. structural heart disease of clinical significance including: * previous cardiac surgery (excluding cabg) * symptoms of congestive heart failure including, but not limited to, nyha class iii or iv chf and/or documented ejection fraction \< 40% measured by acceptable cardiac testing * left atrial diameter of \> 45mm as measured in the parasternal long axis on transthoracic echocardiogram * la volume\>40 ml/m2 * stable/unstable angina or ongoing myocardial ischemia * myocardial infarction (mi) within three months of enrollment * aortic or mitral valve disease \> grade ii * congenital heart disease (not including asd or pfo without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure * prior asd or pfo closure with a device using a percutaneous approach * hypertrophic cardiomyopathy (lv wall thickness \> 1.5 cm) * pulmonary hypertension (mean or systolic pa pressure \>50mm hg on doppler echo 2. prior ablation for arrhythmias other than af within the past three months 3. prior left sided af ablation 4. enrollment in any other ongoing arrhythmia study protocol any ventricular tachy-arrhythmias currently being treated where the arrhythmia or the management may interfere with this study

Keywords: ablation multi-electrode catheter pvac single-tip catheter contact force holter
perioperative bridging - perioperative anticoagulation in the setting of recent intracoronary drug eluting stents

Conditions: Stent Thrombosis

Summary: the purpose of this study is to determine if an intravenous (iv) antiplatelet medication is as safe and effective at preventing clot formation in your stented artery as compared in people who have stopped clopidogrel prior to surgery.

stent thrombosis continues to be associated with a high rate of death or myocardial infarction. while this risk has been ameliorated through the use of the oral antiplatelet agent clopidogrel, there is a small but important subset of patients who will require discontinuation of clopidogrel due to unplanned or emergency surgery. these patients are exposed to a high risk of stent thrombosis during this time period. it is not known whether a strategy of intravenous antiplatelet therapy to "bridge" these patients is effective at preventing the morbidity related to stent thrombosis in the perioperative period. we intend to assess, in a prospective observational manner, the clinical course of patients who have undergone stent implantation less than 6 months prior to a surgical procedure requiring discontinuation of clopidogrel therapy and the efficacy of intravenous antiplatelet therapy to prevent morbidity related to stent thrombosis.

Eligibility criteria:
inclusion criteria: * aged 18 years or greater, able to give consent * des implantation \< or = 6 months prior to admission * undergoing an invasive surgical procedure that will require cessation of clopidogrel therapy for \>48 hours exclusion criteria: * age \< 18 years * refusal to give consent * surgical procedure performed without discontinuation of clopidogrel therapy (or \< 48h of clopidogrel cessation) * ongoing anticoagulant therapy other than aspirin (i.e. warfarin, ticlopidine)

Keywords: drug eluding stents perioperative bridging stents
the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with irritable bowel syndrome (ibs)

Conditions: Colonic Diseases, Functional

Summary: to test the efficacy of herbal medicine in relieving symptoms and change of quality of life of patients with ibs.

irritable bowel syndrome (ibs) is a diagnosis in western medicine characterized by recurrent abdominal pain associated with disturbance in bowel habit such as diarrhea or constipation. epidemiological studies showed that 14% of males and 27% of females in the us (white) have symptoms of ibs. in hong kong, our survey reported a similar prevalence of this condition among chinese (13% in males and 21% in females). ibs is one of the most common conditions leading to seeking of medical care. treatment for ibs has so far been unsatisfactory. numerous medications have been proposed for ibs; however, none is convincingly effective. a review and critique of published drug trials for ibs from 1966 to 1988 concluded that there was no proof that any western medicine is effective for all ibs patients. with the unsatisfactory treatment response of western medicine, many turned to alternative treatment modalities for ibs. traditional chinese medicine is particularly attractive as their effectiveness in treating functional disorders and retaining balance of body functions has been known for centuries. however, there is a lack of convincing clinical data demonstrating the effectiveness of chinese medicine in this condition. in this study, we sought to determine the efficacy of herbal medicine in relieving symptoms and quality of life of patients with ibs. this is a prospective randomized, double-blinded double placebo-controlled study in patients with non-constipation type ibs. patients will be randomized to receive either one of three treatment arms: 1. herbal medicine (hm) + placebo western medicine (wm), 2. wm + placebo hm and 3. placebo hm + placebo wh. each patient will go through an 8-week period of randomized double-blind treatment with either hw, wm or placebo and followed by an 8-week of observation period. the ibs symptom and quality of life will be compared.

Eligibility criteria:
inclusion criteria: * all patients (aged 18-65) attending the gastroenterology clinic of the prince of wales hospital or hong kong baptist university chinese medicine clinics for symptoms of ibs will be enrolled in the study. * ibs is diagnosed by rome ii criteria \[thompson et al. gut 2000\]: at least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features: relieved with defecation; and/or onset associated with a change in frequency of stool; and/or onset associated with a change in form (appearance) of stool * normal colonic evaluation (colonoscopy or barium enema) in recent 5 years * mean score of abdominal discomfort/pain,based on a 5-point scale,at baseline and during the 2-week run-in period * informed written consent for participation into study. * ethical approval will be obtained from the clinical research ethics committee of the university

Keywords: traditional chinese medicine
efficacy and safety study of fosamax plus d in postmenopausal women with osteoporosis (0217a-263)

Conditions: Osteoporosis Postmenopausal

Summary: to demonstrate the efficacy/safety of fosamax plus d


Eligibility criteria:
inclusion criteria: * patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study * patient has been diagnosed with osteoporosis * patient has been postmenopausal for more than 6 months * patient has no contraindication to taking oral bisphosphonates * patient is eligible for dual energy x-ray absorptiometry in spine or hip exclusion criteria: * patients with esophageal dysfunction * patients who can not sit or stand at least 30 minutes * patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial * patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism * patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
gastrectomy with or without drainage (adige)?

Conditions: Gastric Cancer

Summary: prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. in 2015 a cochrane meta analysis on four randomized controlled trials (rct) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. nevertheless the authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from eastern countries. despite the above mentioned limits, enhanced recovery after surgery (eras) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. after 2015 some other retrospective studies have been published, all with inconsistent results. our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.


Eligibility criteria:
inclusion criteria: * all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer siewert type ii or iii, in surgical investigator centres from the beginning of the study until reaching the accrual number * esophageal involvement \<= 2 cm * patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy * open, hybrid, laparoscopic or robotic approach * all types of anastomosis (circular stapled, linear stapled, hand sewn) exclusion criteria: * refuse to sign informed consent * age \<18 * heart failure new york heart association (nyha) class iv * severe liver disease (child \>= 7) * pregnancy * metastatic disease * emergency surgery * palliative surgery * operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy) * lymphnodal dissection \<d1 * reconstruction different from roux-en-y or billroth ii * multiple organ resections (except for cholecystectomy) * gastric cancer with duodenal involvement * intraoperative hyperthermic intraperitoneal chemotherapy (hipec)

Keywords: gastrectomy drain drainage
ultra rapid culture independent detection of high-priority carbapenem resistant enterobacteriaceae directly from blood

Conditions: Bacteremia; Enterobacteriaceae Infections

Summary: the purpose of this study is to develop a new and very rapid diagnostic test for identifying a certain type of bacteria called enterobacteriaceae in blood. rapid identification of bacteria will assist in decreasing the use of antibiotics and help more patients survive bacterial infections of the blood.

it is our overall goal to develop a new diagnostic technology that will facilitate antibacterial stewardship to reduce selective pressure and improve patient outcomes. the institute of medicine has identified antibiotic resistance as one of the key microbial threats to health in the united states and has prioritized decreasing inappropriate use of antimicrobials as the primary solution to address this threat. the emergence of carbapenem resistance among enterobacteriaceae (cre) in the united states represents a recent and severe byproduct of excessive antimicrobial use with a high mortality rate in bacteremia. a major barrier toward decreasing use of antimicrobials is lack of sensitive and accurate rapid diagnostic tests for identifying bacterial etiologies of infection.

Eligibility criteria:
inclusion criteria: * laboratory confirmed gram negative bacilli blood culture exclusion criteria: * pregnancy * prisoner

Keywords: carbapenem-resistant enterobacteriaceae accelerate id/ast
analysis of the electrical muscle activity and resistance to movement in spastic hemiparetic patients.

Conditions: Cerebrovascular Accident

Summary: to evaluate and compare the effects of neuromuscular electrical stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients. the specific objectives are: * evaluate the resistance movement, strength and muscle electrical activity before and after application of neuromuscular electrical stimulation in spastic muscle (gastrocnemius). * evaluate the resistance movement, strength and muscle electrical activity before and after application of neuromuscular electrical stimulation in the spastic antagonist muscle (tibialis anterior). * compare the risk of falls after application of neuromuscular electrical stimulation in both muscles studied.

most hemiparetic patients can develop spasticity, characterized by neuronal hyperexcitability, increased resistance to passive stretch, babinski sign, clonus, reflexes and involuntary spasms skin. as a consequence, there may be contractures and muscle shortening, generating functional limitations. neuromuscular electrical stimulation feature that can control the spasticity through reciprocal inhibition, muscle relaxation and sensory stimulation. the goal will be to evaluate and compare the effects of neuromuscular electrical stimulation when applied in the agonist and antagonist muscles of spastic hemiparetic patients.

Eligibility criteria:
inclusion criteria: * involve patients who have spasticity grade 1, 1 + and 2 of the gastrocnemius muscle, which ambulate with or without assistance devices, patients who tolerate the stimulus and have preserved cognition. exclusion criteria: * involve patients who have severe shortening, joint stiffness, cognitive deficits and patients with hypersensitivity.

Keywords: spastic hemiparesis
effect of ferrous iron and curcumin status on inflammatory and neurotrophic markers

Conditions: Iron Deficiency (Without Anemia)

Summary: introduction: iron is a vital nutrient for many physiological processes including dna production, oxygen transport and neuronal processes. however, several factors limit iron absorption including: limited bioavailability of iron (dietary or supplementation sources), can be subject to dietary iron inhibitors (e.g. calcium). excess iron can cause cellular oxidative stress in the body. curcumin is an active component found in turmeric, known for its anti-oxidant and anti-inflammatory properties. co-administration of iron and curcumin may influence iron, inflammatory status and/or neurotrophic markers in the body.

intervention study with five parallel treatment groups in a randomised, double-blind, placebo-controlled design. study population: healthy participants (male or female) will receive daily supplements (active or equivalent placebos) for 6 weeks (42 days) biological samples (blood and urine samples) are collected at baseline visit (day 1), mid-point (day 21) and end-point (day 42). in addition, pertinent questionnaires (visual analogue scale-fatigue \[vas-f\] and oral iron supplement questionnaire will be collected at the aforementioned time points.

Eligibility criteria:
inclusion criteria: * males \& females (18-40 years of age) * healthy subjects exclusion criteria: * \ 40 years * dieters * consumption of \>21 serving of alcohol/week * any allergies/health issues related to items being ingested * any serious illnesses or those on medication * any pregnant or lactating women * any women who are trying to conceive * any women taking contraceptive medication * any gastrointestinal disorders * any chronic menstrual disorders * any subjects who have undergone the menopause or undergoing the perimenopause transition * any eating disorders * any depression/mental disorders * any abnormal blood pressure levels * those with deficient/excess/abnormal iron levels according to united kingdom (uk) guidelines \&/or haemochromatosis

Keywords: nutraceutical anti-oxidant oxidative status ferrous sulphate curcumin inflammatory status turmeric gastrointestinal fatigue iron hydrocurc supplement
a study to investigate the effects of ketoconazole on lbh589 in patients with advanced solid tumors

Conditions: Non-Hodgkin Lymphoma; Neoplasms

Summary: the primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral lbh589 in adult patients with advanced solid tumors. the extension phase of the study will evaluate the safety and efficacy of lbh589 in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed solid tumors or non-hodgkin's lymphoma with progression on prior standard therapies. * eastern cooperative oncology group (ecog) performance status of ≤ 2 * adequate kidney function and laboratory values exclusion criteria: * patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago * patients who had a heart attack or have unstable angina within past 6 months * heart disease including congestive heart failure and uncontrolled high blood pressure * liver disease, abnormal gastrointestinal (gi) function or ongoing diarrhea * use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study * female patients who are pregnant or breast feeding. other protocol inclusion/exclusion criteria may apply.

Keywords: advanced cancer solid tumors lymphoma hdac lbh589 adults non-hodgkin's lymphoma