Kornimate/medical-research-clean huggingface dataset:
abilify in bipolar disorder for 6 weeks treatment effectiveness

Conditions: Bipolar Disorder

Summary: to demonstrate the efficacy and safety of co-administration of abilify(aripiprazole) with depakote(divalproate) in the acute phase of 6-week treatment of acute mania in patients with bipolar disorder.

further study details as provided by korea oiaa

Eligibility criteria:
inclusion criteria: inclusion criteria: 1. mania or mixed episode of bipolar disorder bipolar disorder, mania or mixed episode according to dsm-iv 2. the periods of mania or mixed episode should be within 3 months, and ymrs score at enrollment be more than 20. 3. male and female between the age of 18 and 65 (in case of child-bearing women, negative pregnancy test results should be confirmed before the administration of the investigational drug and appropriate contraception be used. pregnant and breast-feeding women cannot be included) 4. patients who can consent to participate in this clinical trial 5. patients who understand this trial and comply with all protocol requirements exclusion criteria: 1. patients with the following clinical symptoms diagnosed using dsm-iv: * delirium, dementia, amnestic or other cognitive disorders * schizophrenia or schizoaffective disorder 2. patients who do not respond to clozapine 3. patients who are expected to require the administration of prohibited concomitant drugs during the clinical trial period 4. patients diagnosed with substance-related disorder according to dsm-iv within the past 3 months (abuse, intoxication, dependency and/or withdrawal symptoms). the abuse of benzodiazepines is included with the exception of caffeine or nicotine. 5. patients known to have allergy or hypersensitivity reaction to ablify(aripiprazole) or other quinolinones 6. patients at high risk of suicide attempt or with the history of murder or mental status test 7. patients with the history of neuroleptic malignant syndrome 8. patients with the past history which may cause serious adverse events that can affect the safety or efficacy evaluation during the clinical trial period 9. patients with vital sign or ecg results in the clinically significant abnormal laboratory test patients with clinically significantly abnormal laboratory results, vital sign or ecg results 10. pregnant women or child-bearing women who do not or cannot use appropriate contraception 11. patients given psychotropic medications (except benzodiazepines) one day before baseline visit 12. patients treated with fluoxetine for the last 4 weeks 13. patients who participated in clinical trials with other investigational drugs for the last one month 14. patients with the history of convulsive disorder 15. patients with the history of more than 4 mood episodes each year (rapid cycling) during the last 2 years prior to screening.
early vs. late tracheostomy in patients with guillain -barre syndrome

Conditions: Guillain Barre Syndrome; Mechanical Ventilation

Summary: tracheostomy is one of the most common procedures in the intensive care unit in patients who need prolonged invasive mechanical ventilation. there is controversy in the literature regarding the ideal timing for performing tracheostomy in critically ill patients. early tracheostomy may be associated with a decrease in ventilation days and hospitalization. we would like to investigate whether in ventilated patients with guillain barre syndrome, early tracheostomy will be associated with decreased ventilation days, decreased mortality and shorter hospital and icu length of stay.


Eligibility criteria:
inclusion criteria: all patients aged 18--99 who were admitted to the general intensive care unit from january 2012 to september 2024 with a diagnosis of guillain-barre syndrome who required mechanical ventilation and underwent tracheostomy during icu stay. - exclusion criteria: missing recoreded data -
prediction of rituximab hypersensitivity and desensitization treatment

Conditions: Drug Hypersensitivity Reaction

Summary: this is a single-center prospective single arm study. the purpose of this study is to assess the usefulness of skin test as a diagnostic tool to predict the hypersensitivity to rituximab in chinese population, evaluate the rate of hypersensitivity reactions (hsrs) after the application of active desensitization therapy in the case of a positive skin test result, and investigate the mechanism of hsrs to rituximab.

patients with b-cell lymphomas who need the administration of rituximab are recruited. they undergo skin tests with rituximab before the first infusion of this medicine. in the case of a positive skin test result, the patient will receive the desensitization procedure; if the result of skin test is negative, the challenge test will be administered. drug challenge test consists in administering the desired full dose of rituximab according to manufacturer instructions. challenge is considered positive when it shows an objective hsr. the patient with a positive challenge test will receive the desensitization procedure; while the patient with a negative challenge test will be given standard rituximab infusion in the subsequent chemotherapies. peripheral blood will be drawn from all the subjects during their initial infusion of rituximab. if the patient shows hypersensitive symptoms, the blood will be drawn one hour after the onset of reaction; while if the patient has no hsr in the whole infusion process, the blood will be drawn at the end of infusion and used as negative control. levels of tryptase, specific immunoglobulin e to rituximab, il-6, il-8, and tnf-α in the serum will be tested.

Eligibility criteria:
inclusion criteria: * patients with b cell lymphoma confirmed through pathological biopsy * patients who need the treatment of rituximab and have not received rituximab before exclusion criteria: * pregnant or lactating women * patients taking antihistamines in three days before the skin tests * long-term use of systemic corticosteroid * patients with skin lesions including infection, dermatitis, trauma or scar in both arms * patients with acute attack of asthma * patients with psoriasis * other conditions that the researchers consider inappropriate to participate in the trial

Keywords: rituximab drug hypersensitivity reaction skin test desensitization
thyroid cancer in surgical treated multinodular goiter

Conditions: Goiter, Nodular; Total Thyroidectomy; Thyroid Cancer

Summary: this study aims to investigate, based on existing knowledge, the incidence of occult thyroid carcinoma in a cohort of patients with mng, providing new insights into the prevalence and characteristics of thyroid malignancies in mng. it seeks to contribute to optimizing diagnostic evaluations for patients with multinodular goiter.

this retrospective study included patients with a preoperative diagnosis of multinodular goiter who underwent total or partial thyroidectomy from january 2018 to may 2024 at the department of medical and surgical sciences at the university hospital "ospedali riuniti" in foggia. the study's objective was to investigate the incidence of thyroid carcinoma in patients undergoing thyroidectomy for mng, also analyzing associated demographic and clinical variables.

Eligibility criteria:
inclusion criteria: * patients diagnosed with multinodular goiter via thyroid ultrasound, with or without fna cytology. * patients who underwent surgery. * availability of complete clinical data exclusion criteria: * history of thyroid carcinoma or other thyroid neoplasms. * not completed postoperative follow up. * patients with preoperative fna results indicating malignancy (tir 4-5), suspicion of malignancy (tir 3), or indeterminate significance (tir 1)
a preventive behavioral intervention for young adults with psychotic experiences

Conditions: Psychotic Disorders; Mood Disorders; Anxiety Disorders

Summary: this is a randomized controlled trial testing the efficacy of resilience training in college students with elevated transdiagnostic risk for developing a serious mental illness.


Eligibility criteria:
inclusion criteria: 1. 18-30 years old 2. enrolled as a first or second year student (i.e., freshman or sophomore) in an undergraduate program at the college or university where the intervention takes place 3. students who endorse some psychotic experiences (peter's et al. delusion inventory (pdi) score \> 3) exclusion criteria: 1. inability to provide informed consent 2. not proficient in english 3. current self-reported diagnostic statistical manual 5 (dsm-5) diagnosis with active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by clinical interview with participant, or self-report of a psychiatric diagnosis that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization 4. current enrollment in psychological or behavioral health treatment. 5. current use of psychotropic medications (other than stimulants) prescribed by a physician. 6. a diagnosis of a serious, chronic mental illness as determined by the mini-international neuropsychiatric interview (mini)
a pilot evaluation of adhesives and how they are impacted by output

Conditions: Ileostomy-stoma

Summary: this study investigates the impact of real output on the adhesion of two adhesives.


Eligibility criteria:
inclusion criteria: 1. have given written informed consent 2. be at least 18 years of age and have full legal capacity 3. have had an ileostomy for more than one year 4. have intact skin on the area used in the evaluation 5. has an ileostomy with a diameter up to (≤) 35 mm 6. have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) - exclusion criteria: 1. currently receiving or have within the past 2 month received radio- and/or chemotherapy 2. currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. 3. are pregnant or breastfeeding 4. having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) 5. participating in other interventional clinical investigations or have previously participated in this evaluation
the correlation and intervention of intestinal flora and frailty in the elderly

Conditions: Frailty Syndrome

Summary: the study aim to evaluate the improvement and correlation of soluble dietary fiber (prebiotics) in the frailty of elderly people by a randomized, double-blind, placebo-controlled clinical trial.

100 healthy controls, 100 pre-frailty and 100 frailty elderly will be included. the healthy controls will be received no intervention. the pre-frailty will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin) . the degree of improvements and correlation in frailty will be evaluated three months later.similarly,the frailty also will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin). the degree of improvements and correlation in frailty will be evaluated three months later.

Eligibility criteria:
inclusion criteria: * age ≥65 years; * can get up from a chair and walk 6 meters * clearly consciousness, able to read or use words to express and communicate without difficulty * agree and accept the study plan exclusion criteria: * acute and chronic inflammatory disease of the intestine within 3 months * use of antibiotics, probiotics, prebiotics or synthetics, laxatives or diarrhea medications, proton pump inhibitors or gastric motility drugs within 1 month * dementia * mental illness or blindness * acute infection * cancer

Keywords: frailty, flora
does intramyometrial oxytocin improve outcome in elective cesarean delivery?

Conditions: Postpartum Hemorrhage; Uterine Atony

Summary: oxytocin use has become routine practice in elective cesarean delivery to promote uterine contraction and reduce blood loss. however, there is a lack of consensus regarding the best dose of oxytocin and the most effective route of administration. most dosage and delivery systems have been empirically derived. it is currently our practice at the royal university hospital to start an oxytocin infusion (20u/l) once the baby has been delivered. some anesthesiologists use bolus intravenous oxytocin and it is occasionally requested by the obstetrician. a few obstetricians also choose to inject bolus oxytocin directly into the uterus (intramyometrial). the primary objectives of the study include: 1. determine if our standard 'low dose' oxytocin infusion is adequate prophylaxis to prevent need for additional uterotonics, including additional oxytocin; 2. determine if the addition of prophylactic intramyometrial oxytocin improves both the primary outcome (uterine tone) and secondary outcomes (estimated blood loss, preoperative to postoperative change in hematocrit, need for additional uterotonics, and need for blood pressure support); and 3. act as a dose finding study to determine if the intramyometrial dose is sufficient to augment uterine contraction. the working hypothesis is that the use of intramyometrial oxytocin will not improve primary or secondary outcomes compared to the current practice of an oxytocin infusion alone.


Eligibility criteria:
inclusion criteria: * healthy parturients * elective cesarean delivery * term (\> 37 wks gestational age) as defined by ultrasound or last menstrual period * singleton fetus * vertex presentation * age \> 18 * bmi \< 40 * height \> 5'2" and \< 5"8" * written informed consent exclusion criteria: * placenta previa * multiple gestation * preeclampsia * gestational diabetes or pre-existing diabetes * macrosomia (estimated fetal weight prior to delivery) * polyhydramnios * oligohydramnios * uterine fibroids * more than 2 previous cesarean deliveries * suspected adherent placenta (acreta/increta/percreta) * planned general anesthesia

Keywords: oxytocin intramyometrial
optimizing induction chemotherapy regimens for nd elderly aml patients who are eligible for intense chemotherapy

Conditions: Acute Myeloid Leukemia

Summary: the optimal induction chemotherapy regimen for newly diagnosed elderly aml patients who are eligible for intense chemotherapy is currently not well defined. thus, we intend to conduct a multicenter, randomized, controlled clinical trial to compare the safety and efficacy of three different induction regimens (ven+aza vs da/ia 3+7 vs da/ia 2+5+ven). a total of 90 patients will be enrolled in this study and segregated into thress groups with 30 in each group. patients who achieve cr/cri/crh after using different induction regimens will receive the same consolidation and maintenance therapy. allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist mrd positivity. after completion of the treatment phase, patients entered the follow-up period.


Eligibility criteria:
inclusion criteria: 1. able to understand the study and voluntarily sign informed consent. 2. age: 60\~75 years old, gender unlimited. 3. patients diagnosed with acute myeloid leukemia according to "the 2016 revision to the world health organization classification of myeloid neoplasms and acute leukemia" who haven't been treated. 4. eastern cooperative oncology group (ecog) physical state score: 0-2. 5. fit for intensive chemotherapy. 6. the function of main organs should meet the following standards before treatment: kidney: serum creatinine ≤ 2× upper limit of normal range (uln); liver: total bilirubin ≤ 1.5 × uln, ast and alt ≤ 2.5× uln; heart: myocardial enzymes ≤ 2× uln and normal ejection fraction by cardiac color doppler ultrasound exclusion criteria: 1. patients with acute promyelocytic leukemia 2. patients with runx1::runx1t1 or cbfb::myh11 fusion gene 3. patients with bcr::abl fusion gene 4. patients who have received a prior treatment for aml with chemotherapy, hypomethylating agents or venetoclax before. 5. patients with concurrent malignant tumors requiring treatment 6. patients with active heart disease defined as one or more of the following: (1) uncontrolled or symptomatic angina pectoris;(2) a myocardial infarction 6 months before enrolled; (3)arrhythmia needed medication or with severe clinical symptoms;(4)uncontrolled or symptomatic congestive heart failure (nyha\> grade 2);(5)left ventricular ejection fraction below the lower limit of the normal range. 7. uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment

Keywords: elderly newly diagnosed fit induction regimen
sex differences in risk for alcohol abuse

Conditions: Alcohol Abuse

Summary: this study will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers.

alcohol abuse inflicts enormous physical, emotional, and financial burdens on the individual and society at large. knowing who is at risk for alcohol abuse, and why, is crucial for the development of effective prevention and treatment strategies. alcohol abuse has been traditionally considered a male-oriented problem and as a consequence research on risk factors specific to women has been minimal. however, the sex gap in substance abuse is closing rapidly, and findings from both animal and human studies suggest that females are actually more vulnerable to drug use than males. as such, there is an urgent need to identify sex differences in risk factors for alcohol abuse in order to develop sex-specific prevention and treatment efforts. one clear candidate risk factor is poor inhibitory control, both in terms of baseline levels of inhibition and sensitivity to the disinhibiting effects of alcohol. recent studies suggest that sex hormones affect inhibitory control in drug-free individuals, potentially contributing to sex differences in baseline levels of inhibition. however, the degree to which fluctuations in sex hormones influence sex differences in inhibition-related brain function in sober and intoxicated individuals is not known. the proposed project will determine the neural and hormonal mechanisms underlying sex differences in sensitivity to the disinhibiting effects of alcohol in heavy drinkers. the overall objective of the research is to identify hormonal determinants of alcohol effects on brain activation during response inhibition (bari) in young adult female and male drinkers. bari will be assessed using functional magnetic resonance imaging (fmri) during performance of the stop signal task. this task reliably activates right-lateralized prefrontal regions implicated in inhibitory control. this study will assess bari during iv alcohol (60mg%) and saline infusion in women during the early follicular and mid-luteal phases and in men at matched intervals.

Eligibility criteria:
inclusion criteria: * heavy drinking * alcohol use disorder identification test score above 7 * right-handed * bmi between 19 and 26 * high school education * fluent in english * women must have regular menstrual cycles * not using hormonal contraceptives exclusion criteria: * drug use disorder (scid, dsm-5), other than nicotine or caffeine * meets withdrawal criteria * history of physical or psychiatric disease * contraindication for fmri * pregnant or breastfeeding * smoking more than 5 cigarettes per day

Keywords: brain activation during response inhibition bari fmri stop signal task sex difference menstrual inhibitory control
microdystrophin gene transfer study in adolescents and children with dmd

Conditions: Duchenne Muscular Dystrophy

Summary: this is a controlled, open-label, single-ascending dose study to evaluate the safety and tolerability of sgt-001 in adolescents and children with duchenne muscular dystrophy (dmd). participants will receive a single intravenous (iv) infusion of sgt-001 and will be followed for approximately 5 years. the protocol was amended to drop the control arm after 4 participants were dosed.


Eligibility criteria:
inclusion criteria: * established clinical diagnosis of dmd and documented dystrophin gene mutation predictive of dmd phenotype * confirmed absence of dystrophin as determined by muscle biopsy (ambulatory participants) * anti-aav9 antibodies below protocol-specified thresholds * stable cardiac and pulmonary function * adolescents: non-ambulatory by protocol-specified criteria * children: ambulatory by protocol-specified criteria * stable daily dose (or equivalent) of oral corticosteroids ≥ 12 weeks exclusion criteria: * prior or ongoing medical condition or physical examination, ecg or laboratory findings that could adversely affect participant safety, compromise completion of treatment and follow-up, or impair assessment of study results * abnormal liver function * abnormal renal function * clinically significant coagulation abnormalities * impaired cardiovascular function based on cardiac mri or echo * impaired respiratory function based on fvc % predicted or need for daytime ventilatory support * significant spinal deformity or presence of spinal rods * body mass index ≥ 95th percentile for age * exposure to another investigational drug within 3 months or 5 half-lives prior to screening * exposure to drugs affecting dystrophin or utrophin expression within 6 months prior to screening additional inclusion/exclusion criteria may apply.
prevention of posttraumatic stress symptoms and behavioral problems in children after road traffic accidents: a randomized controlled trial

Conditions: Injury

Summary: the purpose of this study is to study the effectiveness of an early psychological intervention 7-10 days after a road traffic accident on posttraumatic stress and behavior of children and adolescents

within a randomized controlled design the effects of a brief psychological intervention (child, parents) after a road traffic accident shall be examined in a sample of 100 children and adolescents. after a baseline assessment 7-10 days after the accident participants are randomly assigned to an intervention or a control group. both are re-assessed at 2 and 6 months after the accident by means of standardized questionnaires assessing posttraumatic stress symptoms, depression, and behavior.

Eligibility criteria:
inclusion criteria: age 7-16 y command of german language road traffic accident inpatient or outpatient treatment at the university children's hospital zurich no pretraumatic developmental delay exclusion criteria: severe head injury no command of the german language age below 7 y or above 16 y other major systemic illness

Keywords: posttraumatic stress disorder children injury road traffic accident