Kornimate/medical-research-clean huggingface dataset:
evaluate efficacy, safety and tolerability of jtt-861 in subjects with heart failure with reduced ejection fraction

Conditions: Chronic Heart Failure

Summary: this study will evaluate the efficacy, safety, tolerability and pharmacokinetics of jtt-861 administered once daily for 12 weeks in subjects with heart failure with reduced ejection fraction (hfref) who are on a stable, guideline-directed medical therapy for heart failure.


Eligibility criteria:
inclusion criteria: * has a clinical diagnosis of symptomatic heart failure (hf) ≥90 days prior to the screening visit; * is in new york heart association (nyha) functional class ii or iii at the screening visit; * is on stable, guideline-directed therapy for hf, consistent with american heart association (aha), american college of cardiology (acc), heart failure society of america (hfsa) or european society of cardiology (esc) guidelines for ≥4 weeks prior to the screening visit (with at least half of maximal labeled dose of renin-angiotensin-aldosterone system (raas) inhibitors and β-blockers, if tolerated); * has left ventricular ejection fraction (lvef) ≤35% at the screening visit; * has a serum n-terminal pro b-type natriuretic peptide (nt-pro-bnp) level ≥600 pg/ml (or ≥900 pg/ml if the subject has atrial fibrillation or atrial flutter) at the screening visit. exclusion criteria: * has a confirmed acute myocardial infarction (mi) (i.e., type 1) or unstable angina within 90 days prior to the screening visit; * has a history of coronary revascularization (percutaneous coronary intervention \[pci\] and/or coronary artery bypass graft \[cabg\]) or other cardiovascular surgery within 90 days prior to the screening visit or planned cardiovascular surgery during the study through the follow-up visit); * has started cardiac resynchronization therapy (crt) within 90 days prior to the screening visit or has planned crt during the study through the follow-up visit; * has clinically significant congenital heart disease, active myocarditis or constrictive pericarditis; * has current acute decompensated hf requiring additional treatment with diuretics, vasodilators and/or inotropic medications at the screening visit; * has clinically significant chronic renal insufficiency (i.e., estimated glomerular filtration rate \[egfr\] \<30 ml/min/1.73 m2 calculated by the chronic kidney disease epidemiology collaboration \[ckd-epi\] creatinine equation) at the screening visit.

Keywords: jtt-861 efficacy safety tolerability chronic heart failure hfref heart failure
impact of continuous defocused co2 laser vaporisation on the histological malignant transformation of erosive oral lichen planus in patients

Conditions: Oral Lichen Planus

Summary: oral lichen planus (olp) is a common condition with its erosive variant occasionally presenting a management challenge to the clinician. in addition it can have debilitating consequences on the patients' quality of life. the malignant transformation of olp has been well documented. the aims of this work were to measure the number of patients developing malignant transformationof olp to squamous cell carcinoma (scc) comparing patients undergoing traditional symptomatic treatments with those patients that were treated by co2 laser from 2004 - 2011. outcome measures were rated by incisional biopsy (histology report).


Eligibility criteria:
inclusion criteria: * oral lichen planus * histological confirmation of diagnosis * patient willing for treatment exclusion criteria: * patient just does not want to participate as control/study group

Keywords: oral lichen planus recurrence treatment cancer primary disease management
effectiveness of bupropion for smokers recovering from alcohol dependence

Conditions: Smoking Cessation; Alcohol-Related Disorders

Summary: smoking is often a problem for alcohol dependent individuals. many people who seek treatment for alcohol dependence are unable to quit smoking. the purpose of this study is to evaluate the effectiveness of bupropion, an antidepressant medication, in treating smokers receiving treatment for alcohol dependence.

past research suggests that over 75% of alcohol dependent individuals in early alcohol recovery smoke cigarettes; smoking-related mortality exceeds alcohol-related mortality in this population. many alcohol dependent individuals in early recovery are interested in smoking cessation treatment; however, studies indicate that these smokers find it very difficult to quit smoking. more effective treatment methods are needed for smokers in early alcohol recovery. bupropion is a dopaminergic antidepressant that may be effective in treating nicotine dependent individuals. the purpose of this study is to evaluate the effectiveness of bupropion in nicotine dependent individuals receiving treatment for alcohol dependence. in addition, this study will investigate the psychological mechanisms that may mediate the efficacy of bupropion in smoking cessation. we will also collect dna from subjects in order to explore whether response to bupropion is mediated by particular genetic variants in the dopaminergic, metabolic and nicotinic receptor systems of smokers. participants will be randomly assigned to receive either 300 mg of bupropion or placebo, daily for 8 weeks. in addition, all participants will receive a nicotine patch for 7 weeks. this will consist of a 21-mg nicotine patch for 4 weeks, a 14-mg nicotine patch for 2 weeks, and a 7-mg nicotine patch for 1 week. all participants will undergo seven counseling sessions. follow-up visits will occur at weeks 7, 12, and 24. pre-quit variables (e.g., smoking satisfaction) and three post-quit variables (craving, nicotine withdrawal, and negative effects) will be evaluated at all study visits.

Eligibility criteria:
inclusion criteria: * smokes a minimum of 10 cigarettes daily for at least 1 year prior to study entry * abstinence from alcohol and other non-nicotine drugs for between 1 and 12 months at time of study entry * meets criteria for alcohol dependence or abuse in the 12 months prior to study entry exclusion criteria: * history of seizures, head trauma and/or severe hepatic cirrhosis * current use of medications known to affect smoking behavior and/or cessation * use of tricyclic antidepressant medication and monoamine oxidase inhibitors * major depressive disorder within the month prior to study entry * eating disorder within the year prior to study entry * history of bipolar or psychotic disorder * pregnant or breastfeeding * unstable serious medical disorder * history of migraines * currently using smokeless tobacco, pipes, or cigars
rewards for cannabis abstinence-study

Conditions: Cannabis Use Disorder

Summary: the goal of this clinical trial is to investigate the (cost-)effectiveness of contingency management (cm) compared with cognitive behavioural therapy (cbt) for the treatment of cannabis use disorder (cud) in youth (16-22 years). the main questions it aims to answer are: * what is the efficacy of 12 weeks outpatient cm versus cbt in youths with a cud, in terms of cannabis abstinence during the intervention period? * what is the long-term efficacy of cm versus cbt at 6- and 12-months follow-up (fu)? * what is the cost-effectiveness of cm versus cbt at 12-months fu from a societal perspective? study hypotheses are: 1. cm will result in more cannabis-abstinent days than cbt during the intervention; 2. cm is more effective and cost-effective than cbt at 12 months follow-up. eligible patients (n=154) will be randomly assigned to either 12 weeks of outpatient cm or cbt. assessments are conducted by trained research-assistants at baseline, after 6, 12, 26 and 52 weeks, and twice-weekly during treatment and consist of questionnaires, a computer task and collection of urine samples. primary endpoint is the number of biochemically verified cannabis abstinent days in the 12-week treatment period. key secondary endpoint: treatment response: 50% or more reduction in cannabis use days in the past 4 weeks, compared with baseline. the primary outcome will be modelled in the intention-to-treat population in a (negative binomial) regression analysis with treatment group as independent variable and stratification variables as covariates. cost-effectiveness and cost-utility analysis (cea; cua) will be performed from a societal perspective. cea: treatment response is the central clinical endpoint for calculations of incremental costs per responder. cua: incremental costs per qaly (based on euroqol).


Eligibility criteria:
inclusion criteria: * youths (16-22 years) seeking treatment for a primary cud * regular cannabis use (≥14 days) in past 4 weeks * intention to cease cannabis use during intervention * able and willing to attend the treatment center and submit urine samples under supervision twice-weekly * informed consent. exclusion criteria: * health contra-indications (e.g., acute psychosis/suicidality) * insufficient dutch language.

Keywords: contingency management cognitive behavioural therapy cm cbt cost-effectiveness youth randomized controlled trial (rct)
efficacy and safety of lercanidipine and enalapril in patients with essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.


Eligibility criteria:
inclusion criteria: * office blood pressure (bp): sitting diastolic blood pressure (sdbp)100-109 mmhg (inclusive) and sitting systolic blood pressure (ssbp) \< 180 mmhg after a 2 week placebo run-in period * home blood pressure: diastolic blood pressure (dbp)at home ≥ 85 mmhg in the last week of the placebo run-in period * normal electrocardiogram (ecg), first degree atrioventricular block or other changes not considered clinically significant exclusion criteria: * secondary or severe hypertension * history of cerebro- or cardiovascular complications * type 1 or type 2 diabetes on drug treatment * severe renal or hepatic insufficiency

Keywords: hypertension lercanidipine calcium antagonist enalapril
a dose escalation study of adavosertib(mk1775) in combination with 5-fu or 5-fu/cddp in patients with advanced solid tumor (1775-005

Conditions: Solid Tumors

Summary: the study evaluates safety of adavosertib in monotherapy, and in combination with 5-fluorouracil (5-fu) alone or with 5-fu/cis-diamminedichloroplatinum (cddp) in japanese participants with solid tumor. the primary hypothesis is that adavosertib is safe and tolerable in participants with locally advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * parts 1 and 2-a: patient must have a histologically or cytologically confirmed locally advanced or metastatic solid tumor failed to respond to standard therapy, progressed despite standard therapy, or for which standard therapy does not exist * parts 2-b and 3: patient must have a histologically or cytologically confirmed locally advanced or metastatic esophageal, head and neck, or gastric cancer, and be a candidate of 5-fluorouracil and cisplatin regimen defined in this study * patient must have performance status of 0 or 1 on the ecog performance scale exclusion criteria: * patient who has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to the first dose of study drug or who has not recovered from adverse events due to agents administered more than 4 weeks earlier * patient with a known primary central nervous system tumor * patient has known hypersensitivity to any of the components of the combination study therapy or its analogs * patient is receiving "alternative" cancer medications such as plant-derived products and their analogs with anti-tumor activity within 1 week prior to entering the study. * patient must not have prior radiation therapy to more than 30% of the bone marrow and must have recovered for at least 3 weeks from the hematologic toxicity of prior radiotherapy

Keywords: head and neck cancer esophageal cancer gastric cancer
renal function post cardioversion for atrial fibrillation

Conditions: Atrial Fibrillation; Renal Insufficiency; Cardioversion

Summary: atrial fibrillation is a common arrhythmia which requires electrical cardioversion in many patients in order to regain sinus rhythm. in a previous retrospective study a complication of acute renal failure was found in 17% of the patients after cardioversion.(the incidence and prognosis of renal dysfunction following cardioversion of atrial fibrillation. helman y,...gilon d et al:cardiology 2013;124(3);184-9.) another complication previously described after cardioversion is pulmonary edema. in this prospective study the investigators aim to evaluate the risk of acute renal failure post cardioversion. in addition the investigators would like to evaluate hemodynamic changes, fluid balance and sodium levels in patients post cardioversion as a potential mechanism for both acute renal failure and pulmonary edema post cardioversion. in order to assess hemodynamic changes the investigators will use a non-invasive fda approved device called nicas (non-invasive cardiac system). this system calculates cardiac output, cardiac index and peripheral vascular resistance in a non-invasive, fast and accurate way.


Eligibility criteria:
inclusion criteria: * all patients with new onset atrial fibrillation exclusion criteria: * pregnant
beta-2 microglobulin and serum cytokines x haart

Conditions: HIV Patients

Summary: cross-sectional study to assess the behavior of beta-2 microglobulin and serum cytokines tnf-α, ifn-γ, il-2, il-4 and il-10 as indicators of highly active antiretroviral therapy (haart) failure.

objective: to assess the behavior of beta-2 microglobulin and serum cytokines tnf-α, ifn-γ, il-2, il-4 and il-10 as indicators of highly active antiretroviral therapy (haart) failure design: cross-sectional study. methods: eighty-nine hiv-1+ patients and 20 normal individuals were divided into 4 groups: g1- 15 hiv-1+ individuals, previously untreated or without haart for at least six months and cd4+ \< 350 cells/mm3; g2- 31 hiv-1+ individuals undergoing haart without virological therapeutic failure (tf), g3- 43 hiv-1+ individuals undergoing haart with tf, and gc- 20 normal individuals who served as controls for serum cytokines. demographic, clinical and haart data were reviewed, and beta-2 microglobulin, serum cytokines (tnf-α, ifn-γ, il-2, il-4 and il-10), hiv-1 genotyping, plasma viral load and cd4+ and cd8+ lymphocytes tests were performed. key words: beta-2 microglobulin, serum cytokines, hiv-1, resistance, haart, therapeutic failure, genotyping.

Eligibility criteria:
inclusion criteria: * hiv-1-infected individuals * over 18 years old * sign the "written consent form" (wcf) exclusion criteria: * do not presenting other immunosuppression causes, such as neoplasias, transplantations * do not presenting treatment by immunosuppressive substances * do not presenting auto-immune diseases * not be using any type of immunostimulating substances * not at any time of gestation

Keywords: b-2 microglobulin serum cytokines hiv-1 resistance haart therapeutic failure genotyping.
safety and efficacy of oral encochleated amphotericin b (camb/mat2203) in the treatment of vulvovaginal candidiasis (vvc)

Conditions: Vulvovaginitis; Yeast Infection; Yeast Infection Vaginal; Candidiasis, Vulvovaginal

Summary: this is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg camb and 400 mg camb compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe vvc.

this is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg camb and 400 mg camb compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe vvc. approximately 75 women with moderate to severe vvc will be randomized to 1 of 3 treatment groups (200 mg camb, 400 mg camb, or fluconazole) to achieve approximately 25 subjects in each group. the primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral camb for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe vvc. the secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. tertiary objectives include pharmacokinetics.

Eligibility criteria:
key inclusion criteria: informed consent clinical diagnosis of moderate to severe vvc negative pregnancy test vaginal ph less than 4.5 key exclusion criteria: has an intolerance or hypersensitivity to any amphotericin b (amb) product, or to azole antifungal drugs receiving antifungal therapy unrelated to vvc or has evidence of systemic fungal infections requiring antifungal therapy has received treatment for vvc within the past 30 days or has experienced 4 or more episodes of vvc in the past 12 months has another cause of vulvovaginitis has other urogenital infection(s) that would potentially alter their response to disease has another vaginal or vulvar condition that would confound the interpretation of clinical response has significant laboratory abnormality at screening has any known azole-resistant candida infection; has any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk
implication of cd35, cd21 and cd55 in exudative age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: the purpose of this study is to determine a possible implication of cd21, cd35 and cd55 in the pathogenesis of age-related macular degeneration. the aim is to asses a difference in expression rates of these factors on amd-patients and a healthy control group.


Eligibility criteria:
inclusion criteria: * man and women over 18 years old * filled out informed consent * diagnosis of non-exudative/ exudative age related macular degeneneration exclusion criteria: * inherited retinal diseases * other acquired retinal/ macular * missing informed consent
environmental enteropathy among infants and children with growth faltering

Conditions: Growth Failure; Enteropathy

Summary: the study was conducted on 200 patients with growth faltering on 2 phases. in the first phase the patient received nutritional rehabilitation with polymeric formula for 12 weeks then they were reassessed by anthropometric measurements and those whose weight remained below -2 sd for age and sex on the who scores were defined as non responders and entered the second phase. in the second phase upper gastrointestinal endoscopy was done and then patients received nutritional rehabilitation with peptide based formula and probiotics then were reassessed after 8 weeks.


Eligibility criteria:
inclusion criteria: * patients whose weight below -2 sd for age and sex on the who scores. exclusion criteria: * secondary cases of malnutrition or undernutrition. * patients with symptoms of git problems as chronic vomiting, chronic or bloody diarrhea, chronic abdominal distension, hematemesis or bleeding per rectum. * patients who can't commit to a follow up visit every two weeks.
effects of levothyroxine on endothelial function of patients with subclinical hypothyroidism

Conditions: Subclinical Hypothyroidism

Summary: hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. we aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg levothyroxine or placebo. the flow-mediated dilation and intima media thickness are evaluated before and after the study.


Eligibility criteria:
inclusion criteria: * age 18 to 65 * confirmed subclinical hypothyroidism exclusion criteria: * receiving of other treatments for hypothyroidism * patients with other major medical disorders * smoking * hyperlipidemia * obesity

Keywords: subclinical hypothyroidism atherosclerosis cardiovascular disease endothelial function prevention
biologic basis for multiple sclerosis disease progression in rrms patients treated with gilenya

Conditions: Multiple Sclerosis-Relapsing-Remitting

Summary: this study will determine whether in rrms patients receiving gilenya there is a link between disease progression and biologic markers.

the biologic basis that determines disease progression in multiple sclerosis (ms) patients remains to be defined. we propose that a long term study of patients where inflammatory activity of the disease is expected to be controlled on treatment, will identify patients into cohorts of those whose disease is deemed to be stable with those patients whose disease has been deemed to progress. once the two groups have been identified, it will then be possible to assess whether there are differences in biologic markers between the two groups. these markers would then have the potential to be used to monitor disease progression or be predictors for patient response to drug treatment.

Eligibility criteria:
inclusion criteria: * deemed by the subject's treating physician to be a suitable candidate for gilenya therapy in accordance with the canadian product monograph for gilenya * has an overall edss not above 7.0 * is not currently receiving gilenya * is able to perform adequately for edss assessment and cognitive tests * is able to undergo a mri * is able to provide blood samples exclusion criteria: * is over 65 years of age and under 18 years of age * has less than 4 weeks of discontinuation with steroid treatment for a relapse.

Keywords: multiple sclerosis, relapsing-remitting gilenya fingolimod
mronj and polynucleotides-hyaluronic acid hydrogel (regenfast®)

Conditions: Medication Related Osteonecrosis of the Jaw

Summary: several circumstances or conditions, such as wound extension or disease, can affect the hard and soft tissue healing after surgical treatment of mronj. supportive therapies are therefore needed to help tissues wound healing. the primary objective of this pilot clinical case series is to evaluate the post-operative wound healing in a group of patients undergoing surgical therapy for mronj with intraoperative application of a gel based on polynucleotides and hyaluronic acid (pn+ha) (regenfast®)


Eligibility criteria:
inclusion criteria: * patients older than 18 years * provided informed consent * mronj stage 1 and stage 2 diagnosis, in accordance to sicmf-sipmo classification * need to undergo surgical treatment of mronj exclusion criteria: * patients with history of head and neck radiotherapy * neurological and psychiatric conditions * pregnancy * mronj stage 3 diagnosis * patients who will receive a re-treatment for mronj * patients with general contraindication for oral surgery * patients unable to attend the out-patients visits scheduled by the protocol