Kornimate/medical-research-clean huggingface dataset:
binaural beat music combined with rhythmic photic stimulation on depression

Conditions: Depression

Summary: background: previous studies have suggested that non-pharmacological treatments, such as binaural beat music (bbm) and rhythmic photic stimulation (rps), may help improve depressive symptoms and enhance quality of life. however, their effectiveness in elderly patients with depression remains unclear. objectives: this study aims to investigate the effects of combining bbm and rps on improving depression, quality of life, and heart rate variability (hrv) in elderly patients with depression. methods: this study was conducted as a single-blind randomized controlled trial. forty-eight elderly patients with depression were recruited from a long-term care institution in taiwan and randomly assigned to either the bbm and rps group or the sham group. participants received 20 minutes of intervention daily, monday to friday, for 12 consecutive weeks. during the intervention, participants in the bbm and rps group listened to 10hz bbm (embedded with classic old songs) and wore rps glasses that provided 10hz light stimulation. in contrast, participants in the sham group listened to classic old songs and wore rps glasses without the 10hz light stimulation.


Eligibility criteria:
inclusion criteria: * inclusion criteria for this study were: a) diagnosed with major depressive disorder by a psychiatrist and stable for more than six months; b) aged 65 and above; c) no cognitive impairment, with a mini-mental state examination (mmse) score above 24 and able to understand the questionnaire content; d) no severe physical illnesses and no significant hearing impairments; e) not using antidepressants within three months before and during the intervention. exclusion criteria: * exclusion criteria included: a) history of mixed psychiatric disorders, including schizophrenia, bipolar disorder, and dementia; b) experiencing acute illness (or pain) and unstable physiological conditions; c) history of epilepsy or potential for seizures; d) substance abuse; e) participation in electroconvulsive therapy or transcranial electrical stimulation within one month before and during the intervention.
alcohol brief counseling in primary care

Conditions: Alcohol Drinking

Summary: this study evaluates the effectiveness of a brief intervention for the reduction of alcohol use among risky alcohol users in primary care delivered by paramedics. half of the participants will receive a brief intervention and half will receive written guidelines on safe alcohol use.

randomized controlled trial with a pragmatic emphasis undertaken in real world primary care. the brief intervention has been designed and piloted by the mental health team at the chilean ministry of health, as also the written support material. this intervention is the same that is being implemented national wide. the implementation will include training of the paramedics, and then an accreditation session with a simulated participant in a double sided mirror. randomization will take place on site using a opaque envelope. the sequence will be keep on site in a secured box. data will be registered by the same person delivering the intervention and kept safe at the clinical sites. once a month the data will be physically transferred to the operational center at the san joaquin site of the catholic university of chile. bimonthly visits will be performed to the centers by a member of the team to assure that the protocol is being followed and data audit. the participants will receive an economical incentive for the follow up visit. participants will be reached throw telephone at least twice to schedule that visit. if not possible, a telephonic outcome assessment or a domiciliary visit will be performed to minimize the lost in follow up.

Eligibility criteria:
inclusion criteria: * audit score between 8 and 15 * able to read * haven't received a similar intervention in the last 3 months exclusion criteria: * clients in treatment for alcohol use disorder * alcohol use treatment seekers * pregnant woman * severe physical or psychiatric pathology not stable

Keywords: alcohol drinking hazardous alcohol use risky alcohol consumption heavy alcohol consumption
a study of nivolumab plus ipilimumab, ipilimumab alone, or cabazitaxel in men with metastatic castration-resistant prostate cancer (checkmate 650)

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate the effectiveness, safety and tolerability of nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate cancer (mcrpc).


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status 0-1 * current evidence of metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic resonance imaging (ct/mri). * ongoing androgen deprivation therapy (adt) with a gonadotropin-releasing hormone (gnrh) analogue or a surgical/medical castration with testosterone level of ≤1.73nmol/l (50ng/dl) for crossover phase for participants originally randomized to arm d3 or arm d4 only: * previously randomized to arm d3 or d4; had histologic confirmation of adenocarcinoma of the prostate and evidence of stage iv disease (as defined by american joint committee of cancer criteria (ajcc criteria) prior to randomization exclusion criteria: * presence of visceral metastases in the liver * active brain metastases or leptomeningeal metastases * active, known, or suspected autoimmune disease or infection * prior treatment with an anti-pd-1, anti-pd-l1, anti-pd-l2, or anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways for crossover phase for participants originally randomized to arm d3 or arm d4 only: * prior radiation therapy within 14 days prior to first dose of nivolumab combined with ipilimumab * have received systemic anti-cancer therapy after the last dose of study treatment (ipilimumab or cabazitaxel) other protocol-defined inclusion/exclusion criteria apply
dose response of fractional exhaled nitric oxide (feno) to inhaled steroids in mild-to-moderate asthma

Conditions: Asthma

Summary: asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. in asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. this 'inflammation' is the root of the problem in asthma. doctors have different ways to measure the inflammation in the airways. one way is to measure a gas called nitric oxide (no) on the breath. this is made by the lungs when asthmatic inflammation is present. the investigators have been using no as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. in most asthmatics, even small doses of inhaled steroids (preventers) can reduce the no levels to normal, but in some people this does not seem to happen. the investigators now have portable no machines that are designed for patients to use in the home. the investigators want to follow no readings in patients with high levels to measure how they respond to different doses of steroid inhalers. the investigators hope this will help the investigators better understand asthma inflammation and treatments.


Eligibility criteria:
inclusion criteria: * diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day * feno greater than 30ppb on treatment exclusion criteria: * recent rti or prednisolone * smoking within 1 year or 10 pack years * abpa, copd, bronchiectasis
antioxidant and nmda receptor blocker wins anoxic brain damage of korea ohca patients

Conditions: Cardiac Arrest

Summary: this study aims to investigate the efficacy and safety of neu2000kwl, a neuroprotectant, in patients resuscitated from out-of-hospital cardiac arrest and receiving therapeutic hypothermia.

lack of good neurological recovery is the biggest hurdle in the treatment of out-of-hospital cardia arrest. neu2000kwl, a n-methyl-d-aspartate (nmda) receptor antagonist and an antioxidant, attenuated cerebral neuronal death and reduced hypoxic injury of brain in preclinical studies. phase i clinical study has revealed that neu2000kwl is very safe for treating human. in current study, the investigators will assess the efficacy of neu2000kwl to compare the neurological biomarker, brain imaging, and clinical outcomes of patients successfully resuscitated from out-of-cardiac arrest treated by 3-day infusion of neu2000kwl with patients assigned to placebo arm.

Eligibility criteria:
inclusion criteria: 1. 19 years to 80 years (adult) 2. out-of-hospital cardiac arrest caused by non-perfusing cardiac rhythm 3. successful resuscitation accompanied by rosc time of more than 20 min 4. therapeutic hypothermia is planned or initiated 5. the first infusion is planned within 4 hours after rosc 6. informed consent is obtained from patient or family member(s) 7. no concern with previous cardiovascular surgery exclusion criteria: 1. hypersensitivity to aspirin or sulfasalazine 2. unwitnessed cardiac arrest 3. cpr time \> 60 min 4. therapeutic hypothermia is not planned 5. use of extracorporeal membrane oxygenation (ecmo) at initiation of in-hospital resuscitation (e-cpr) 6. very poor prognosis is expected: patients with (a) non-cardiac or respiratory arrest, (b) poor basal neurological status (c) secondary cardiac arrest caused by trauma, major bleeding, acute neurologic disease including stroke or tumor, (d) multiorgan failure or advanced malignancy 7. pregnant or lactating women 8. participated in other clinical studies within 90 days before randomization; or participating in other clinical trials at present 9. intracranial bleeding verified by first brain ct imaging 10. the investigators consider the patients are not suitable for this trial

Keywords: neu2000kwl cerebral performance category out-of-hospital cardiac arrest neuroprotection glutamate n-methyl-d-aspartate (nmda) receptor antagonist anti-oxidant free radical
outcomes of open versus robotic-assisted laparoscopic posterior component separation in complex abdominal wall repair

Conditions: Abdominal Wall Hernia

Summary: this is a retrospective european multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rtar) or open transversus abdominis release (otar).

consecutive patients who undergo bilateral tar in the treatment of their ventral incisional hernia in two european hernia centers are included in the study. a retrospective analysis of a prospectively maintained database and electronic patient files will be performed. primary endpoint of the study was length of postoperative hospital stay. secondary endpoints are intraoperative complications, in-hospital complications, overall and surgical site related complications during the first 30 postoperative days, overall and surgical site related complications during the reported follow-up period, and hernia recurrence during the reported follow-up period. data on the following variables wlll be collected. * patient characteristics: age, sex, body-mass index (bmi), comorbidities, smoking habits, previous hernia repair and hernia dimensions * intraoperatively: skin-to-skin operative time, wound contamination class (according to the center for disease control and prevention (cdc) classification)15, administration of antibiotics, mesh type used, mesh size, closure of the hernia defect, combined surgical procedures and intraoperative complications. * postoperatively at discharge: length of postoperative hospital stay and in-hospital complications. * postoperatively at 30 days after surgery: overall (according to the clavien-dindo classification)16 and surgical site related complications17, readmission rates during the first 30 days after surgery. * during follow-up: duration of reported follow-up, reoperation rates and hernia recurrences during the reported follow-up period.

Eligibility criteria:
inclusion criteria: * all consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia. exclusion criteria: * unilateral transversus abdominis release * patients with a stoma or parastomal hernia

Keywords: abdominal wall surgery open surgery robotic surgery transversus abdominis release posterior component separation technique
a short, animated storytelling video to increase knowledge about sodium intake as a cardiovascular risk factor

Conditions: Sodium Excess; Cardiovascular Risk Factor; Education Entertainment Intervention; Short, Animated Storytelling

Summary: this study will evaluate the effect of a short, animated storytelling intervention video on sodium intake as a major risk factor for cardiovascular disease on immediate and medium-term retention of knowledge about the risks of cardiovascular diesaes due to increased sodium intake. we will also measure voluntary engagement with the content of the short, animated storytelling intervention video on positive psychological capital. in this 4-armed, parallel, randomized controlled trial, 10,000 adult, us participants will be randomly assigned to (1) a short, animated storytelling intervention video on sodium as a cardiovascular disease risk factor followed by surveys assessing the facts om sodium and cardiovascular disease conveyed in the video (2) the surveys only, (3) an attention placebo control video followed by the before mentioned surveys, and (4) an arm that is exposed to neither the video nor the surveys. two weeks later, participants in all four arms will complete all of the surveys. the primary outcome is knowledge about the cardiovascular disease risk associated with increased sodium intake (immediate and medium-term). the major scondary outcome is the extent of voluntary engagement with the short, animated storytelling video content.


Eligibility criteria:
inclusion criteria: * registration with the prolific academic platform exclusion criteria: * none
electroacupuncture for the treatment of agitated symptoms of alzheimer's disease

Conditions: Agitation Associated With Alzheimer's Dementia; Alzheimer's Dementia

Summary: the purpose of this study is to evaluate the efficacy of electroacupuncture in the treatment of agitation symptoms in patients with alzheimer's disease (ad). meanwhile the study aims to explore the brain central mechanism of electroacupuncture in the treatment of agitation symptoms in patients with ad by using resting state functional magnetic resonance technology.

this is a multicenter, parallel-group, patient-blinded and outcome-assessor-blinded randomized controlled trial consisting of two stages: a 8-week treatment period followed by a 8-week follow-up period. the study aims to assess therapeutic efficacy and safety of electroacupuncture for agitated symptoms of ad. approximately 224 ad patients with symptoms of agitation will be randomly assigned to the electroacupuncture group or micro-electroacupuncture group. 50 patients in each of the two groups will be selected to complete rs-fmri scans before the initial treatment and after the last treatment in order to investigate the central mechanism underlying the effects of electroacupuncture treatment on functional activity in patients with ad patients with symptoms of agitation.

Eligibility criteria:
inclusion criteria: 1. meet the revised draft diagnostic criteria for alzheimer's disease published by the alzheimer's association in 2023 2. meet the 2023 ipa definition of agitated symptoms of cognitive impairment 3. cohen mansfield agitation inventory (cmai)≥45 points 4. have been on stable anti-ad medication (cholinesterase inhibitors, etc.) for more than 1 month 5. if taking antipsychotics, the medication regimen for agitation (antipsychotics) is stable for 1 month prior to randomization 6. subject and legal guardian and caregiver sign informed consent. exclusion criteria: 1. there are contraindications for acupuncture treatment, such as the tendency of acupoint bleeding or allergy to metal 2. received electroacupuncture treatment in the past 2 weeks 3. at the time of the screening, participants are participating in other clinical trials or planned to participate in other clinical trials in the next 17 weeks.
trial of an herb and mineral combination product on fasting glucose in adults at risk for developing diabetes

Conditions: Prediabetes

Summary: this is a multi-center, randomized, double-blind, placebo-controlled study in approximately 104 subjects (52 per group) to evaluate the effectiveness of an herb and mineral combination product on fasting serum glucose levels in subjects with impaired fasting glucose. the study consists of 5 visits: a screening visit, followed by a baseline visit (at which eligible subjects will be randomized to product to consume throughout the 12-week supplementation period), followed by supplementation period visits at 3, 6 and 12 weeks after baseline.

the target population of this clinical trial is otherwise healthy, pre-diabetic adults who present with impaired fasting glucose.

Eligibility criteria:
inclusion criteria: * be male or female, at least 18 years of age * if age ≥45 years, must have a body mass index ≥ 25 kg/m2 * if age \<45 years, must have a body mass index ≥ 25 kg/m2 and present with at least one additional risk factors for developing diabetes. * agree to use contraception throughout study period, unless postmenopausal or surgically sterile (women only) * be able to understand the nature and purpose of the study including potential risks and side effects * be willing to consent to study participation and to comply with study requirements * have a finger stick fasting blood glucose between 105 and 140 mg/dl and a serum fasting glucose between 100 and 125 mg/dl, measured at screening exclusion criteria: * have diabetes (type i or ii) or an hba1c measurement \>6.5% at any time in the past or at the screening visit * have been taking within 2 weeks of screening any dietary supplement including vitamin and mineral complexes; herbal supplements; fish oil; fiber supplements; or any herbal ingredient/product that significantly affects glucose metabolism * have been taking within 4 weeks of screening any prescription or over-the-counter (otc) medication that significantly affects glucose metabolism, including but not limited to, sulfonylureas, meglitinides, biguanides, thiazolidinediones, alpha-glucosidase inhibitors, inhibitors of dipeptidyl peptidase 4 (dpp-4 inhibitors), systemic corticosteroids * daily use of non-steroidal anti-inflammatory drugs (nsaids) (daily baby aspirin use and continuous use of nsaids for 3 days or less for acute aches and pains are acceptable) * any co-morbidity or treatment that could, in the opinion of the investigator, preclude the subject's ability to successfully and safely complete the study or that may confound study outcomes * anticipated changes in dietary patterns or physical activity levels during the study, including attempts at body weight reduction * eating disorder * polycystic ovary syndrome * known allergies or intolerance to any substance in the study product * are pregnant or breastfeeding women * history of alcohol, drug, or medication abuse * have participated in another study with any investigational product within 1 month of screening * had a recent (\<3 months) gastrointestinal surgery or any planned surgery during the clinical study
efficacy and safety of asf-1096 cream 0.5% in the treatment of discoid lupus erythematosus (dle) lesions (2)

Conditions: Discoid Lupus Erythematosus

Summary: lupus erythematosus (le) is an autoimmune disorder that includes a broad spectrum of clinical forms. one of these forms, discoid lupus erythematosus (dle) is a chronic disfiguring disease confined to the skin. the aim of this pivotal trial is to investigate the efficacy and safety of asf-1096 cream 0.5% in the treatment of patients with dle or sle presenting newly developed discoid lesions.


Eligibility criteria:
inclusion criteria: * a clinical diagnosis of either dle or sle * histological results from biopsy confirming the diagnosis (biopsy can be taken at screening) * is prepared to grant authorised persons access to the medical records * has signed informed consent exclusion criteria: * has an active skin disease other than dle or another progressive or serious disease that interferes with the study outcome * has scarring at the target lesion * systemic treatment of sle
ventricular arrhythmias in patients undergoing mitral valve surgery

Conditions: Mitral Regurgitation; Mitral Valve Prolapse; Ventricular Tachycardia

Summary: study objectives: * to assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (mvp) from baseline to 6 months after surgery * to characterize the molecular landscape of arrhytmogenic mvp study design: -prospective explorative observational study study population: -90 patients with arrhytmogenic mvp and without arrhytmogenic mvp (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. all patients will be evaluated with cardiac magnetic resonance (cmr) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery

prospective explorative observational study in which the impact of mitral valve surgery for mitral regurgitation on ventricular arrhytmias and cmr imaging biomarkers will be examined in patients with arrhythmogenic mvp compared to those without arrhythmogenic mvp (controls). molecular phenotyping of endocardial biopsies in patients with and without arrhythmogenic mvp will be performed as well as molecular phenotyping of the myxomatous disease in explanted valves by means of deep rna single cell sequencing. using cmr in 90 patients with mvp before and 6 months after mitral valve surgery, the presence and type (reversible vs irreversible) of papillary muscle and cardiac fibrosis will be characterized. to assess change in ventricular arrhytmic burden after surgery, patients will undergo continuous seven day monitoring with e-patch at baseline and at 6 months after mitral valve surgery. during surgery, explanted mitral valves (in patients undergoing replacement) as well as endocardial biopsies will be collected.

Eligibility criteria:
inclusion criteria * age 18 and over * patients with and without (controls) arrhythmogenic mvp in need of mitral valve surgery for primary mitral regurgitation according to current standard of care exclusion criteria * secondary mitral regurgitation * primary mitral regurgitation not due to degenerative disease (including rheumatic disease) * co-existing moderate or severe aortic valve disease * congenital heart disease * inherited or acquired cardiomyopathy * non-incidental or symptomatic coronary artery disease * uncontrolled atrial fibrillation (resting heart rate \> 100/min) * pregnancy * unable to undergo cmr