Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of rel-1017 as monotherapy for major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: this is an outpatient, 2-arm, phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of rel-1017 once daily (qd) as a monotherapy for major depressive disorder.


Eligibility criteria:
inclusion criteria: * adults 18 to 65 years, inclusive. * diagnosed with major depressive disorder (mdd) based on structured clinical interview for diagnostic and statistical manual of mental disorders, dsm-5 (scid-5) for mdd. * current major depressive episode. exclusion criteria: * any current and primary psychiatric disorder other than major depressive disorder. * severe alcohol or substance use disorder. * history of bipolar i and ii disorder, psychosis, and/or mania. * acute or chronic condition that, in the investigator's opinion, would limit the subject's ability to complete or participate in this clinical study. * prior participation in a ketamine, esketamine, dextromethorphan or any other nmdar- antagonist study, or received esketamine at any time.

Keywords: rel-1017
a comprehensive approach to relief of digestive symptoms in cystic fibrosis: cards-cf

Conditions: Cystic Fibrosis; Digestive System Disease; Genetic Disease; Respiratory Tract Diseases; Lung Diseases; Pancreatic Disease

Summary: development of a new patient reported outcome measure (prom) that will measure the daily burden of gastrointestinal symptoms over the previous 24 hour period for people with cystic fibrosis.

development of a patient reported outcome measure (prom) in line with fda guidance. the prom is intended for daily use to measure the symptom burden of gastrointestinal symptoms for people with cf over the last 24 hours. * development of the initial conceptual framework underpinning the prom and confirmed through a patient focus group. * primary item (question) generation for the prom which will then be refined through a series of interviews with people with cf. * testing of the items through an online patient questionnaire for testing of frequency, burden and impact of the items. * piloting testing of the draft prom daily for 2 weeks via smartphone app. the recall period of the prom will be gastrointestinal symptom burden over the previous 24 hours. potential participant's will be identified through 6 uk cf care centres at nottingham university hospitals nhs trust (paediatric and adult cf centres), leeds teaching hospital nhs trust, manchester university nhs foundation trust, royal brompton and harefield nhs foundation trust and kings college hospital nhs foundation trust. in addition, recruitment for the survey and trialing the prom on a smartphone app will also take place via social media and is therefore also open to people with cf from outside these cf centres.

Eligibility criteria:
inclusion criteria: * people with cystic fibrosis age 12 years and over * confirmed diagnosis of cystic fibrosis based on genotype or sweat chloride testing * capacity to consent, or to understand the requirements of the study where parental consent is required exclusion criteria: * \< 12 years age * unable to give informed consent

Keywords: patient reported outcome measure (prom) gastrointestinal symptom burden symptom score gut abdomen
testing a shortened version of the alan's game

Conditions: Psychopathic Personality Trait

Summary: it has been demonstrated that behavior on the alan's (altruism-antisocial) game is related to moral elevation response. moral elevation is a positive response to another's act of generosity "of charity, gratitude, fidelity, generosity or any other strong display of virtue". the constellation of emotional, physical and psychological aspects of a moral elevation response have been well described. moral elevation can be elicited with stimulus stories or videos and measured with self-report questionnaires. the experience of moral elevation is associated with subsequent prosocial and affiliative behaviors. additionally, the research has linked moral elevation response with behavior on the alan's game. this study will test whether behavior on the alan's short game v.2 is related to moral elevation response and extend prior work by testing whether viewing the moral elevation stimulus prior to playing the alan's short game v.2 is associated with differences in game behavior. the study will also test whether psychopathic traits will correlate with game behavior.

hypotheses and specific aims: aim 1: examine the similarities and differences in behaviors on the alan's short game v.2 seen with the two active trial (at) types (where red cross donation will be reduced and subject will gain money (at1) vs. where the red cross donation will increase and study participants will lose money (at2). hypothesis 1: number of accepted trials of at1 and at2 from session 1 will significantly correlate. aim 2: test the effects of elevation vs. nature video on change in alan's short game v.2 behavior between sessions 1 and 2. hypothesis 2: subjects who view the elevation stimulus video (study arm 1) will show increases in prosocial behavior while those watching the nature video will not. aim 3: test the association between psychopathic traits and costly helping and determine whether the influence of elevation on costly helping dissipates with increasing levels of psychopathic traits. hypothesis 3: psychopathic traits, as measured by the levenson self report psychopathy scale, will significantly and negatively correlate with the amount of prosocial behavior in session 1. hypothesis 4: using subjects from study arm 1, change in alan's short game v.2 behavior (session 2 minus session 1) will be negatively correlated with psychopathic trait scores.

Eligibility criteria:
inclusion criteria: • age 18-25 years exclusion criteria: • refusal to provide informed consent

Keywords: psychopathic traits moral elevation prosocial behavior
event-related potentials in management of children with attention-deficit/hyperactivity disorder

Conditions: Attention Deficit Disorders With Hyperactivity; Attention Deficit Disorder; Hyperkinetic Syndrome

Summary: the investigators try to objectively and scientifically explore various brain function impairments in adhd children by electrophysiologic tests, with and without medication.

the aims of this study are to explore the various cognitive impairments of adhd children, to differentiate various subtypes of adhd children, and to investigate the efficacy of anti-adhd drugs on various cognitive performance of adhd children by event-related potentials(erp). children, aged six to 18 years old, are enrolled and assigned to three groups (normal control, pure adhd, and adhd with comorbidities). adhd children fulfill the dsm-iv-tr criteria for the diagnosis of adhd. adhd children are evaluated by chinese version of snap-iv rating scale for rating adhd-related symptoms before and after medication. eeg and audiometric testing are required for every participant to exclude dialeptic seizures and hearing impairment respectively. methylphenidate (either immediate-release or extended-release formulations) or atomoxetine hydrochloride is given to adhd participants.continuous performance task (cpt) and erp tasks are applied.

Eligibility criteria:
inclusion criteria: * health children * or clinical diagnosis of attention-deficit hyperactivity disorder exclusion criteria: * hearing impairment * uncorrectable visual impairment * epilepsy

Keywords: attention deficit disorders with hyperactivity attention deficit disorder event related potential
monitoring of patients with inflammatory bowel diseases: the experience of the reference center of the emilia-romagna

Conditions: IBD - Inflammatory Bowel Disease

Summary: the study is observational with descriptive purposes, aimed at enhancing and deepening current knowledge and providing a foundation for future studies. specifically, it seeks to identify predictive factors for aggressive disease progression, the development of frailty, the need for surgery and post-surgical outcomes, the development of neoplasia, the assessment of drug safety, and the quality of life in relation to medications or post-surgery.

the total duration of the study is expected to be 10 years. partial analyses will be conducted during the study for data publication. the clinical data required by the protocol will be collected in a pseudonymized form by personnel designated by the principal investigator in an electronic case report form (crf). analysis methodology: descriptive statistical analyses will be used to describe the characteristics of the enrolled patient sample. continuous variables will be summarized using means, standard deviations, minimum and maximum values, and percentiles. discrete or nominal variables will be reported as absolute frequencies and relative percentage frequencies. to study the predictive factors for disease progression, development of frailty, need for surgery, etc. (primary objectives), multivariate models (logistic regression analysis) will be used, and odds ratios with 95% confidence intervals (or - ci 95%) will be calculated. the calculation of frequencies and the estimation of event incidences, such as drug resistance, development of comorbidities, extraintestinal manifestations, and other observed episodes/events (secondary objectives) will be accompanied by their respective 95% confidence intervals (ci 95%). analyses may focus on subcohorts of patients with different demographic and clinical-diagnostic characteristics to evaluate their varying risk probabilities. data will be processed using ibm spss statistical software (version 25.0).

Eligibility criteria:
inclusion criteria: * signed informed consent * age \> 14 years * diagnosis of inflammatory bowel disease (crohn's disease, ulcerative colitis, indeterminate colitis, microscopic colitis) according to ecco guidelines * having undergone at least one outpatient visit and/or hospitalization at the regional reference center for ibd "massimo campieri" * acquisition of written informed consent from the patient and/or both parents/legal guardian exclusion criteria: - none
internet-based cognitive-behavior therapy for children with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this study is to evaluate the feasibility and effectiveness of internet-delivered cognitive behavior therapy (icbt) for children (7-11 years) with obsessive-compulsive disorder (ocd).

the primary objective of this study is to investigate if internet-delivered cognitive behavior therapy (icbt) is a feasible and effective treatment for children (7-11 years) with obsessive-compulsive disorder (ocd). the design of the study is a pilot study with 16 participants. the treatment duration is 12 weeks. the primary outcome measure is the children's yale-brown obsessive compulsive scale (cy-bocs). study participants will be followed up 3 months after treatment.

Eligibility criteria:
inclusion criteria: * primary dsm-5 diagnosis of ocd * total score of ≥16 on the children's yale-brown obsessive-compulsive scale (cy-bocs) * age between 7-11 years * ability to understand swedish * daily access to the internet * a parent that can co-participate in the treatment * participants on psychotropic medication must had been on a stable dose for the last 6 weeks prior to baseline assessment exclusion criteria: * diagnosed autism spectrum disorder, psychosis, bipolar disorder, severe eating disorder, organic brain disorder, learning disability * suicidal ideation * not able to understand the basics of the icbt self-help material * have completed a course of cbt for ocd within last 12 months (defined as at least 5 sessions cbt including exposure and response prevention) * on-going psychological treatment for ocd or another anxiety disorder
leo19123 cream in the treatment of atopic dermatitis

Conditions: Atopic Dermatitis

Summary: to compare the efficacy and safety of two different dose combinations of leo19123 (calcipotriol and leo80122) with leo19123 cream vehicle for 3 weeks in the treatment of patients with atopic dermatitis


Eligibility criteria:
inclusion criteria: * clinical diagnosis of atopic dermatitis according to hanifin and rajka * the score of erythema, induration/papulation, excoriation and lichenification, four of the five clinical signs in the total severity score, should at least correspond to moderate involvement, i.e. severity greater than or equal to 2, at visit 1 * treatment area amenable to topical treatment * attending a hospital outpatient clinic or the private practice of a dermatologist * following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period * males between 18-50 years exclusion criteria: * systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine) or corticosteroids within 4 weeks prior to randomisation. (inhaled or intranasal steroids for asthma or rhinitis may be used) * puva or uvb therapy within 4 weeks prior to randomisation * topical treatment with immunomodulators (pimecrolimus, tacrolimus) or corticosteroids from who groups iii or iv within 2 weeks prior to randomisation * other topical therapy on the treatment area (except for the use of emollient on the entire body and use of hydrocortisone cream 1% on ad lesions on head and neck) within 1 week prior to randomisation * use of any other kind of treatment (drug, non-drug) for ad during the study except for the use of: - investigational product on trunk and limbs lesions only during the treatment phase - hydrocortisone cream 1% on head and neck lesions - emollient on the entire body * use of anti-histamines during the study * current diagnosis of exfoliative erythrodermia * clinical infection (impetiginised atopic dermatitis) on the treatment area * planned exposure to amount of sun or ultraviolet light during the study that may affect atopic dermatitis * known or suspected hypersensitivity to component(s) of the investigational product * known or suspected severe renal insufficiency or severe hepatic disorders * patients with history/signs/symptoms suggestive of an abnormality of calcium homeostasis associated with clinically significant hypercalcaemia * patients with history of cancer including skin cancer * patients with history of an immunocompromised disease (e.g. lymphoma, hiv, wiskott-aldrich syndrome) * current participation in any other interventional clinical trial * patients who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks prior to randomisation * previously randomised in this study * patients known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)
craving, binge eating and obesity

Conditions: Binge Eating Disorder; Obesity

Summary: this research study is designed to look at the effectiveness of bupropion for reducing binge eating in overweight persons with binge eating problems. participants in the study will receive either bupropion or placebo ("sugar" pill, inactive medication) as an outpatient for eight weeks. in addition, participants will be given the option to receive 8 weeks of free behavioral weight loss treatment. this treatment, known to be effective for reducing binge eating and helping people lose weight, will be administered following the medication phase and at no cost. it is expected that compared to placebo, bupropion will produce greater reductions in binge eating.

the proposed study is an 8-week randomized placebo-controlled trial to test the efficacy of bupropion in treating overweight women with binge eating disorder (bed). bupropion is an antidepressant that has demonstrated efficacy in smoking cessation and some efficacy in obesity treatment. since cravings and depressed mood are hypothesized to contribute to binge eating episodes, bupropion is a promising psychopharmacological agent in treating binge eating and reducing weight. it is hypothesized that compared to placebo, bupropion will produce significantly greater reductions in the frequency of binge eating. secondary goals are to explore interrelationships between treatment and changes in cravings, frequency of binge episodes, emotional eating, and weight loss. following the medication phase of the trial, all patients will be offered 8 weeks of behavioral weight loss treatment administered by doctoral-level psychologists specializing in eating disorders and weight management.

Eligibility criteria:
inclusion criteria: * bmi 25-50 * able to travel to clinical site (new haven, ct) for bi-weekly visits. exclusion criteria: * predisposition to seizures * history of anorexia or bulimia nervosa * current type i or type ii diabetes mellitus

Keywords: binge eating obesity medication craving emotional eating
study of seraprevir in combination with sofosbuvir in chronic genotype 2,3,6 hepatitis c virus infection patients

Conditions: Hepatitis C Virus Infection

Summary: this study was to assess the safety and efficacy of seraprevir in combination with sofosbuvir in patients with hepatitis c (hcv) genotype2,3,6. efficacy was assessed by the rate of sustained viral response (svr) 12 weeks after the discontinuation of therapy (svr12).


Eligibility criteria:
inclusion criteria: hepatitis c virus (hcv) genotype 2,3,6 infection (confirmed at screening). hcv rna greater than 10,000 iu/ml at screening. participant must be willing and able to comply with the protocol requirements. weight was more than 40 kg. age is between 18-75,either sex. exclusion criteria: co-infection with hepatitis b virus or human immunodeficiency virus (hiv). infection with hcv non-genotype 2,3,6,or infection with mixed genotype,or genotype cannot be confirmed. medical history of major functional organ transplantation. suffering from serious blood system disease(such us thalassemia/sickle cell anemia). participation in a clinical study within 3 months prior to first dose
radiofrequency ablation versus balloon cryoablation in elderly patients with atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study compares the procedural characteristics and effectivity of radiofrequency ablation and cryoablation in patients with atrial fibrillation that are 75 years or older.

radiofrequency and cryoballon ablation have been shown to be comparable to each other in terms of safety and effectivity in patients with atrial fibrillation. however, elderly patients have been underrepresented in the previous studies. the number of older patients with atrial fibrillation is high and the number of who undergo an ablation procedure for atrial fibrillation increases steadily. this prospective randomized trial compares the effectivity (recurrency of atrial arrhythmias) and periprocedural characteristics of the two established ablation methods in patients who are 75 years or older.

Eligibility criteria:
inclusion criteria: * patients with recurrent symptomatic paroxysmal or persistent atrial fibrillation * at the day of their inclusion in the study the patients have to have completed the 75th year of life exclusion criteria: * dementia * presence of left atrial thrombus * left atrial volume\> 50 ml/m² * renal failure (gfr≤ 30 ml/min) * comorbidity with an expected survival of 12 months or less.

Keywords: ablative treatment of atrial fibrillation ballon cryoablation radiofrequency ablation elderly patients
comparison of stapler line bleeding control techniquessurgery

Conditions: Obesity, Morbid

Summary: introduction rygb surgeon; have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.the purpose of this study; emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.

the question of the availability of cautery in rygb surgeons

Eligibility criteria:
inclusion criteria: * morbid obese patients exclusion criteria: * cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during lrygbp and those who had previously undergone obesity surgery (revision surgery)
vaccine+hbig versus vaccine+placebo for newborns of hbsag+ mothers

Conditions: Chronic Hepatitis B

Summary: prevention of perinatal transmission is essential to decrease the global burden of chronic hbv. recombinant hbv vaccine and hepatitis b immunoglobulin (hbig) given after delivery to the newborns of hbsag positive mothers is the standard of care for prevention of hbv in babies. some studies have however, shown that vaccine alone may be equally effective. hence, immunoprophylaxis with hepatitis b vaccine with or without hbig is effective in prevention of transmission of overt hbv infection to the babies. the primary outcome measure of most of the trials on immunoprophylaxis was the occurrence of hepatitis b, defined as a blood specimen positive for hepatitis b surface antigen (hbsag). however, whether this immunoprophylaxis also prevents hbsag negative hbv infection (occult hbv infection) in babies is not known. in the present study the investigators evaluated the efficacy of the two regimens; vaccination alone and compared it with vaccination plus hbig administration at birth in preventing transmission of both overt and occult hbv infection to the newborn babies.


Eligibility criteria:
inclusion criteria: * newborn babies of mothers who were found to be hbsag positive exclusion criteria: * babies of mothers who had any symptoms of liver disease during the pregnancy such as jaundice, pruritus, ascites, or gastrointestinal bleed; * babies of mothers taking anti-viral treatment during pregnancy; * babies of mother with pregnancy related complications; and * babies of mothers who refused to participate in the study.

Keywords: hepatitis b hbsag antenatal pregnancy vertical transmission placenta hbv dna
early bandage removal post-cesarean delivery

Conditions: Wound Disruption; Wound Infection

Summary: women undergoing their first second or third cesarean section will be randomized into two groups. one group will have the abdominal bandage removed at 6 hours post-surgery and the other group will have the bandage removed at 24 hours. staple removal will be at 5 - 7 days for both groups. the incision will be inspected at the time of staple removal. the 2 groups will be compared for incision disruption and infection. also, the women will be asked about their satisfaction for time of bandage removal.


Eligibility criteria:
inclusion criteria: * age of 18 to 44 * elective cesarean section, primary or repeat * low risk pregnancy exclusion criteria: * under the age of 18 and above the age of 44 * diabetes, preeclampsia or other pregnancy complications * unable or unwilling to give informed consent * chorioamnionitis * bmi over 35 * more than 3 cesareans

Keywords: cesarean bandage removal infection disruption satisfaction patient satisfaction