Kornimate/medical-research-clean huggingface dataset:
cyclosporine in takotsubo syndrome

Conditions: Takotsubo Cardiomyopathy

Summary: the goal of this clinical trial is to investigate the impact of repetitive acute cyclosporine a (csa) bolus therapy in patients suffering from tts with an elevated risk of impaired outcome. the main question it aims to answer is whether csa reduces myocardial injury (primary outcome). participants will receive csa or placebo at baseline and every 12h in the first 24h after study inclusion. researchers will compare csa and the placebo group to see if a) myocardial injury is reduced, and b) ejection fraction is improved compared to baseline, as well as several other secondary endpoints over a one year follow-up.

takotsubo syndrome (tts) has been suggested to be caused by catecholamine excess with myocardial inflammation-enhanced cardiac injury. substantial morbidity and mortality have repeatedly been reported, even though reduced ejection fraction frequently recovers spontaneously. so far there is no evidence-based treatment available. in a clinically relevant mouse model of catecholamine-driven tts, cyclosporine a (csa) bolus therapy markedly improves outcome, likely mediated via suppression of calcineurin-driven inflammation. the investigators have thus designed a pilot multicentre randomized controlled trial (rct) to investigate the impact of repetitive csa bolus therapy vs. placebo in acute tts patients with an increased risk of intrahospital complications and a 32% estimated 5-year mortality. as primary outcome myocardial damage will be compared between groups via high-sensitive troponin t plasma area under the curve (auc). recovery of cardiac function, the extent of myocardial oedema at 72h, length of hospital-stay, 30-day-, and 1-year composite clinical outcome as well as psychosocial and quality of life self-assessment will be secondary endpoints. the results of this trial may reveal csa as a first pathophysiology-driven treatment option of tts and enable a phase iii follow-up trial with outcome parameters as primary endpoint.

Eligibility criteria:
inclusion criteria: 1. adult patients (age ≥ 18 years) 2. symptom onset \< 24h 3. with a high probability of tts: 1. intertak diagnostic score \> 39 and 2. regional wall motion abnormality (wma) consistent with tts; no coronary intervention (pci), or reperfused myocardial ischemia according to mri 4. with a high probability of impaired outcome: 1. intertak prognostic score \>15 or 2. geist score \> 19 exclusion criteria: 1. suspected infection 2. cardiac arrest, ventricular fibrillation, invasive ventilatory support 3. known hypersensitivity to csa, egg, peanut, or soya-bean proteins 4. renal insufficiency (creatinin clearance \< 30 ml/min/1.73m²) 5. liver insufficiency 6. uncontrolled hypertension (\>180/110 mmhg) 7. hypericum perforatum, stiripentol, aliskiren, bosentan, or rosuvastatin treatment 8. pregnancy or women of childbearing age without contraception 9. any disorder associated with immunological dysfunction \< 6 months prior to presentation 10. immunosuppressive therapy 11. participation in another clinical trial

Keywords: takotsubo syndrome troponin cyclosporine inflammation acute heart failure
virtual prism adaptation therapy on hemispatial neglect

Conditions: Stroke; Recovery of Function; Rehabilitation; Perceptual Disorders; Virtual Reality Exposure Therapy

Summary: the purpose of this study is to investigate the effect of virtual prism adaptation therapy on hemispatial neglect in chronic stroke patients. this study is the randomized, double-blind, sham-controlled, cross-over design. total 10 patients will be allocated randomly to either real virtual prism adaptation therapy or sham therapy with the wash-out period of more than 2 weeks. two sessions (20min/session) per day, for 5days (total 10 sessions) will be provided. behavioral outcomes will be measured before and after completing a total of 10 sessions therapy.


Eligibility criteria:
inclusion criteria: * 3 months after stroke onset * 2 or more tests indicative of hemispatial neglect in following 3 tests: 1)line bisection test, 2)albert's test, 3)drawing test. * ability to recognize the target object, hand trajectory in the immersive virtual reality * 16 points or more in the korean version of mini-mental state examination exclusion criteria: * previous stroke or traumatic brain injury history * can not cooperate during the therapy, due to delirium or aphasia * unstable medical conditions * severe psychiatric symptoms that interfere with the therapy participation (e.g. severe depression, agitation, psychotic symptoms) * pregnancy * can not maintain sitting posture
neuman systems model and infertility stress

Conditions: Infertility; Intrauterine Insemination

Summary: in this study, it is aimed to determine the effect of neuman systems model based nursing approach on stress an coping with stress for women received intrauterine insemination (iui) treatment. the study has been planned as a single blind experimental study in pretest-posttest design with randomized control. sample group is going to be chosen from women who have taken iui treatment in ankara university fertility diagnosis, treatment, research and application center. sample size of the study has been determined as 72 such that intervention=36 and control=36. while gathering data, personal information form, the compi fertility problem stress scales and the compi coping strategy scales are going to be used. in the scope of the study, four interviews with women in intervention group are going to be done during iui treatment.


Eligibility criteria:
inclusion criteria: 1. getting a diagnosis of primary infertility 2. volunteering to participate in the study 3. being over the age of 18 4. taking iui treatment 5. not being diagnosed with a chronic disease 6. not being diagnosed with a psychiatric illness 7. do not have a problem that can interfere with written and verbal communication. exclusion criteria: 1. to want to leave the study, 2. cancellation of treatment.
scaling up ncd interventions in south east asia

Conditions: Diabetes Mellitus, Type 2; Hypertension; Cardiovascular Diseases

Summary: the suni-sea study is an intervention study that measures effectiveness and cost-effectiveness of prevention and early diagnosis of diabetes and cardiovascular diseases in communities and primary healthcare (phc) facilities in indonesia, myanmar and vietnam.

the study takes place in vietnam and indonesia in intergenerational self-help clubs (ishgs), where community members assemble for activities concerning social, economical improvement and health and well-being. volunteers in these ishgs are trained in performing screening for diabetes and cardiovascular diseases and counselling participants concerning healthy living, or referral to primary healthcare facilities, if needed. at phc level further diagnosis and if needed treatment is provided and referral back to ishgs is done for lifestyle interventions. in indonesia screening takes place in the posbindu programme, where trained volunteers (cadres) screen and counsel participants. if needed referral to puskesmas (primary healthcare facilities is done, where further diagnosis and treatment takes place. activities for health promotion and lifestyle interventions take place under supervision of the posbindu programme. in myanmar and indonesia individual monitoring and health education of participants is done through mobile applications. measuring of uptake, follow-up and adherence to interventions is done through routine data collection, through surveys, and through semi-structured interviews and focus group discussions.

Eligibility criteria:
inclusion criteria: * all adults living in geographical area where research takes place exclusion criteria: * persons who are not able to come to location of screening, due to illness or other chronic condition causing immobility.

Keywords: prevention early diagnosis lifestyle intervention
multi-omics approach of risk stratification for patients with de novo acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the investigators will use machine learning to identify features on bone marrow smears and select features that are related to gene mutations, gene expression, or prognosis. the investigators will then use genome-wide transcriptomic profiling to investigate gene expression that is associated with patients' outcomes. the investigators will design a next-generation sequencing panel with unique molecular index and assess its feasibility and robustness in detecting measurable residual disease and optimize the panel/platform/bioinformatic pipeline. finally, the investigators will use machine learning to integrate bone marrow smear features, gene mutations, gene expression, and measurable residual disease to construct a comprehensive risk assessment system that is based on multi-omics data. the investigators believe that such a platform will help physicians to design the most appropriate treatment strategies for individual patients, not only advancing the concept of precision medicine but also improving patients' prognoses.


Eligibility criteria:
inclusion criteria: 1. diagnosed with acute myeloid leukemia at the national taiwan university hospital 2. ever enrolled in 201802021rinc、202109078rinb、201709072rinc exclusion criteria: nil

Keywords: acute myeloid leukemia machine learning artificial intelligence risk stratification
efficacy and safety of dbs in patients with treatment-resistant depression

Conditions: Treatment Resistant Depressive Disorder

Summary: the habenula (hb) is an ancient structure, located at the center of the dorsal diencephalic conduction system, a pathway involved in linking forebrain to midbrain regions. an increasing number of studies indicated that the lateral habeluna (lhb) is overactivity during depressive behaviors in rats, where it could drive the changes in midbrain monoamine neurotransmitter linked to depression. however, the efficiency and mechanism of deep brain stimulation (dbs) of the lhb and/or its major afferent bundle (i.e., stria medullaris thalami) could treat treatment-resistant major depression (trd) is still unclear. this research will investigate the effectiveness and mechanism of bilateral mri compatible and long-term lfp recordable dbs to habenula and/or its major afferent bundle for treatment trd patients.


Eligibility criteria:
inclusion criteria: * age 18-70 years old; * dsm-iv diagnosis of major depression disorder of psychiatrists; * more than 3 year's history of depression and failure to respond to a minimum of three different antidepressant treatments; * failure or intolerance or unwilling of an adequate course of electroconvulsive therapy (ect) during any episode; * hamd-17≥20; * gaf≤50； * capacity to provide informed consent (understanding of the study purpose and methods); exclusion criteria: * obvious medical and psychiatric comorbidities; * alcohol or substance abuse/dependence within 12 months; * antisocial personality disorder, dementia, current tic disorder; * subject has a history of 2 or more suicide attempts \< 12 months prior to the screening testing; * pregnancy and/or lactation; * there are contraindications for dbs surgery and chronic stimulation.

Keywords: deep brain stimulation habenula functional magnetic resonance imaging
relationship between spine coronal alignment and lower limb biomechanical in scoliosis

Conditions: Scoliosis

Summary: to examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents

background: adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. numerous studies deal with the aetiology of the disease, x-ray morphology and classification of curvatures and how the disorder disrupts the spinal biomechanical balance, however the disorder is a complex three-dimensional deformity that affects the body as a whole, and these effects must not be overlooked. no cross-section studies were found assessing the connection between sagittal or coronal balance and the biomechanical parameters of the lower extremity. hypotheses: null hypothesis there are no statistically significant relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents. research question: what are the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents? purpose: to examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents

Eligibility criteria:
inclusion criteria: * adolescents with age 10-18 years * complaining of dorsolumbar scoliosis * curves (apex lies between d10 and l4) * curve magnitudes greater than 15 degrees and less than 90 * using or not using brace * all maturity levels (risser = 0-5) exclusion criteria: * other types of scoliosis ; congenital or neuromuscular * current physical therapy or medical treatment for scoliosis, * contracture or surgery affecting the lumbar spine or lower limbs * pathologies such as inflammatory diseases * congenital anomalies * neurological disorders like cerebral palsy or ataxia * dislocations * visual or auditory problems

Keywords: scoliosis spine alignment lower limb biomechanics
clinical trial of the dual vector base editor for the treatment of the chd3-r1025w mutation

Conditions: Developmental Delay Disorder; Intellectual Disability; Rare Diseases

Summary: to evaluate the safety, tolerability and preliminary efficacy study of a single intrathecal injection of the dual vector aav-chd3-r1025w base editor for the treatment of developmental disorders caused by the r1025w mutation in the chd3 gene


Eligibility criteria:
inclusion criteria: * clinical diagnosis of snijders blok-campeau syndrome * heterozygous mutation of c.3073c\>t, p.(arg1025trp) in the chd3 gene * normal liver, heart and immune function * normal coagulation and platelet counts exclusion criteria: * brain tumor or intracranial space-occupying lesion * contraindications to administration of lumbar puncture or sheath injection administration * persistent status epilepticus or recurrent epileptic control instability * presence of unstable systemic disease including active bacterial, fungal or hiv, hepatitis a, hepatitis b infection * serum anti-aav neutralizing antibody titer \>1:50 (elisa immunoassay) * treatment with immunological agents other than protocol-specified prophylaxis within 3 months * prior gene therapy * participation in another clinical trial, or treatment with another investigational product within 30 days or 5 half-lives * known allergy to any investigational product
mobile advanced multi-parameter reporting in patients wearing a novel device: utilization during cardiac rehabilitation

Conditions: Heart Attack; Cardiac Event; Cardiac Disease; Cardiac Infarct; NSTEMI; STEMI

Summary: advanced remote multi-parameter reporting during cardiac rehabilitation (maps-iii). the primary purpose of this observational study is to collect baseline information of cardiac rehabilitation usage in the us for post-myocardial infarction (mi) patients with ef \> 35% while wearing the zoll ams device for 30 to 60 days. secondary data on biometrics, arrhythmias, symptoms, and healthcare utilization will provide additional background information on this population during the early post-mi cardiac rehabilitation period.

to collect baseline data on cardiac rehabilitation usage (referrals and completion) in recent post-mi patients with ef \> 35%.to collect data on ams-derived biometric data (e.g. hr, activity) and arrhythmias, and subject-reported symptoms, beta blocker/ivabradine usage (dose/changes) and cardiovascular events. the participating centers will enroll consenting subjects in a sequential manner to avoid preferential selection of patients to participate in the study. subjects will be consented by the center study staff, and if eligible will wear the fda-cleared ams device for 30-60 days. subject demographic information and clinical history will be obtained at the time of enrollment. during the study period, the prescribing physician-investigator will be blinded to ams data. final subject follow-up will be at 3 months. a sample size of 150 subjects is estimated in order to have 100 subjects with at least 30 days of ams use for analysis.

Eligibility criteria:
inclusion criteria 1. both male and female subjects who are between 21 - 75 years of age, inclusively 2. subjects who are consented and enrolled into the study prior to discharge from the qualifying acute myocardial infarction 3. subjects with a consistent ef \>35% post the qualifying acute myocardial infarction exclusion criteria 1. subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, an implanted cardioverter defibrillator (icd), a cardiac resynchronization therapy device, subcutaneous icds, pressure monitors, and loop monitors. 2. subjects with wearable cardioverter defibrillator, holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time. 3. subjects with a skin condition preventing them from wearing the ams device. 4. subjects who are non-ambulatory for any reason. 5. subjects who are self-reporting to be pregnant. 6. subjects with comorbidities that would preclude adherence to a cardiac rehabilitation program - at the discretion of the physician. 7. subjects participating or planning to participate in another interventional study during the protocol-defined study period

Keywords: heart attack myocardial infarction stemi nstemi
study to intervene with nutrition for gastroparesis

Conditions: Gastroparesis

Summary: the study is a self-controlled study in which we will assess the nutritional effects of the kate farm peptide 1.5 nutritional formula in patients with gastroparesis, relative to their pre-enrollment nutritional diet regimen.

the study is a prospective self-controlled study in which we will assess the nutritional effects of kate farm peptide 1.5 nutritional formula in patients with gastroparesis, relative to their pre-enrollment diet regimen. the duration of the study will be 12 weeks. we plan to recruit a total of 30 patients. patients will undergo a baseline measurement of their height, weight, symptom burden, resting energy expenditure, inflammation, and microbiome. after study initiation, patient will undergo repeat testing at 1- and 3-months post-enrollment. including the screening and baseline visits, there will be a total of 4 visits required to complete the study.

Eligibility criteria:
identify inclusion criteria. * male or female gender * ages 18 to 65 * established diagnosis of gastroparesis confirmed by gastric emptying study within the last 5 years. * no changes to gastroparesis medications in the 3 months prior to recruitment. * patients with hysterectomy, appendectomy, cholecystectomy and fundoplication are ok to participate. * able to give informed consent. * patient willing to supplement diet with kate farms * ability to adhere to the study visit schedule and other protocol requirements. identify exclusion criteria. * are nursing or pregnant. * diagnosis of mechanical small bowel obstruction within 3 months prior to recruitment * patients with a history of gastric surgery, including gastrectomy, small bowel resection or bariatric surgery * the use of narcotic medications in the month prior to study enrollment or during the study period * diagnosis of short gut syndrome * allergic to any ingredients in the kate farms formula * untreated small intestinal bacterial overgrowth
equivalence study to compare two strengths of creon in china

Conditions: Pancreatic Insufficiency

Summary: this will be an open-label, randomized, multicenter, cross-over study in 60 subjects with pei delivering data of 60 subjects for pancreatin enteric-coated capsules 25000 and of 60 subjects for pancreatin enteric-coated capsules 10000. the study will be conducted in up to 10 sites in china.


Eligibility criteria:
inclusion criteria: * signed informed consent * subjects ≥ 18 years * a) chronic pancreatitis must be documented in the medical file by at least one of the following methods: * imaging techniques (ultrasound, ct, mri, or endoscopic ultrasound) * ercp (endoscopic retrograde cholangiopancreatography) * plain film of the abdomen with pancreatic calcification or * b) partial or total pancreatectomy ≥ 30 days prior to enrollment and without current postsurgery complications * pei proven by human fecal elastase ≤ 100 µg/g stool (during the screening period) * subjects without creon (pancreatin enteric coated minimicrospheres) intake in the past three months * females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g. depo-provera™), an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide exclusion criteria: * subjects with a history of fibrosing colonopathy * solid organ transplant * surgery affecting the stomach or bowel, except pancreatectomy or appendectomy * surgery affecting the stomach or bowel, except pancreatectomy or appendectomy * subjects with recurrent malignant tumors of any kind * use of an immunosuppressive drug or chemotherapy * acute phase of pancreatitis * acute phase of pancreatitis * subjects who are not able or willing to ingest 90g fat/day (± 10 g fat/day) during the cross-over periods or are not willing to collect complete stools during the demarcation period. * subjects in an instable condition after pancreatic surgery (karnofsky index \< 70) * known infection with hiv * pregnancy or lactation * current excessive alcohol intake or drug abuse * investigational drug intake within prior 30 days * known allergy against pancreatin of porcine origin or to any of the excipients of pancreatin enteric-coated capsules * suspected non-compliance or non-cooperation * celiac disease, crohn´s disease * ileus or acute abdomen in the medical history * mental disability or any other lack of fitness, in the investigator's opinion, to preclude subject's participation in or to complete the study * any acute or chronic disease (i.e infectious diseases) which may limit the hospitalization, dietary adherence or stool collection or completion of the study procedures