Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the efficacy and safety of karxt for the treatment of manic episodes in bipolar-i disorder (balsam-2)

Conditions: Bipolar Disorder Type I With Mania or Mania With Mixed Features

Summary: this is a phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. the primary objective of the study is to evaluate the efficacy of karxt compared to placebo in treating symptoms of mania during a 3-week inpatient period. the duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.


Eligibility criteria:
inclusion criteria: * participants must have a primary diagnosis of bipolar-i disorder established by a comprehensive psychiatric evaluation. * participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks). * participants must require hospitalization for the acute exacerbation or relapse of mania. * participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug. * participants must have a young mania rating scale (ymrs) score of ≥ 20 at screening and at baseline. * participants must have a clinical global impressions-bipolar (cgi-bp) ≥ 4 at screening and at baseline. exclusion criteria: * participants must not have any primary diagnostic and statistical manual of mental disorders (5th edition, text revision) (dsm-5-tr) disorder, other than bp-i with mania or mania with mixed features within 12 months before screening, including bp-i with depression (for previous 3 months only), bp-ii disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. * participants must not have a primary diagnosis of bp-i with rapid cycling (≥ 4 distinct mood episodes in one year). * participants must not have a dsm-5-tr diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test. * participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the investigator's clinical assessment and the columbia-suicide severity rating scale (c-ssrs). * participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results. * other protocol-defined inclusion/exclusion criteria apply.

Keywords: bipolar-i disorder mania bipolar-i disorder with mania
drug-coated balloon therapy for in-stent restenosis and de novo coronary lesions

Conditions: Coronary Heart Disease

Summary: this was a single-center, prospective, open-label, observational study. patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the cardiology department of our hospital in january 2022. the primary endpoint was late lumen loss within 12±3 months after surgery.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 years with coronary heart disease; 2. if the target lesion stenosis ≥70% is complicated with angina pectoris or evidence of myocardial ischemia, dcb should be administered; 3. residual lumen diameter stenosis ≤30% after lesion pretreatment and dcb, no vessel dissection, or type a or b dissection, and timi blood flow level 3; 4. target lesions were treated with dcb for the first time. exclusion criteria: 1. intraoperative implantation of salvage stent in dcb; 2. acute myocardial infarction occurred within 1 week after dcb operation; 3. less than 3 months of dual antiplatelet therapy after dcb operation, or more than 1 month of discontinuation of antiplatelet therapy; 4. the position of the stent could not be determined by coronary angiography. 5. desmovascular disease or left main artery disease; 6. atrial fibrillation; 7. patients with severe heart failure, valvular heart disease, renal insufficiency, severe infection and autoimmune disease.

Keywords: drug-coated balloon percutaneous coronary intervention
remote monitoring in diabetes disease management

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: the primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.

to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.

Eligibility criteria:
inclusion criteria * between 18 and 64 years of age as of january 1, 2008 * diagnosis of diabetes mellitus (listed icd-9-cm diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period) * continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days * able to provide written informed consent for study participation exclusion criteria * advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl * selected cancers (one or more claims in the most recent 12-month period) * hiv/aids (one or more claims in the most recent 12-month period) * heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period) * cirrhosis of the liver (one or more claims in the most recent 12-month period) * current participation in another lifescan study or other diabetes-related clinical trials * medicare is primary source of insurance coverage * unable to understand written and spoken english

Keywords: remote monitoring type 1 diabetes type 2 diabetes
efficacy and safety of fenofibrate combined with udca in pbc patients with an incomplete biochemical response to udca

Conditions: Primary Biliary Cirrhosis

Summary: the purpose of this protocol is to conduct a trial in a selected population of patients with pbc based on an incomplete biochemical response after 12 months of udca therapy.

primary biliary cholangitis is a chronic cholestatic liver disease, ursodeoxycholic acid (udca) is the only drug approved for the treatment of pbc. although udca can improve the clinical outcomes in patients with pbc, about 40% of pbc patients show an incomplete biochemical response to this treatment, accordingly have a significantly increased risk of developing liver transplantation or death. therefor there is a urgently needed for better therapies for these patients. the development of new treatments is therefore needed. the fenofibrate is the candidate, there is now a substantial body of circumstantial evidence supporting that fenofibrate is well tolerated and can improve biochemical response in pbc patients with incompleted response to udca. the purpose of this protocol is to conduct a trial in a selected population of patients with pbc based on an incomplete biochemical response after 12 months of udca therapy.

Eligibility criteria:
inclusion criteria: 1. pbc patient , previous treatment with udca 13-15 mg/kg/day for at least 1 year, showed incomplete biochemical response; 2. patients who showing an incomplete biochemical response to udca as defined by: alp \> 3uln,ast\> 2n ,total bilirubin \>17 µmol/l after ≥ 12 months of udca at the dose of 13 - 15 mg/kg/day. 3,signed informed consent after careful review of information and study details. exclusion criteria: 1. hypersensitivity to fenofibrate 2. administration of the following drugs at any time during the 3 months prior to screening for the study: methotrexate, colchicines, azathioprine, systemic steroids. 3. decompensation pbc, such as recurrent variceal hemorrhage, uncontrolled encephalopathy or refractory ascites 4. anticipated need for liver transplantation within one year 5. co-existing liver diseases such as acute or chronic viral hepatitis, alcoholic liver disease, choledocholithiasis, autoimmune hepatitis, biopsy-proven non-alcoholic fatty liver disease, wilson's disease and hemochromatosis 6. acute or chronic renal failure 7. known history of cholecystitis with intact gallbladder 8. pregnant or nursing women

Keywords: udca, fenofibrate
evaluation of the awakening capability by a vibrating bracelet (brassard)

Conditions: Congenital Central Hypoventilation Syndrome; Patients With Nocturnal Ventilatory Assistance; Healthy Volunteers

Summary: as part of developing a relay alarm project, the aim of the study is to test a sleeper's capability to wake up via a vibrating alarm around the wrist (vibrating bracelet).


Eligibility criteria:
inclusion criteria: * speak french * with social security for healthy volunteers : no sleep disorder, known neurological or respiratory pathology for patients : congenital central hypoventilation syndrome or ventilatory assistance whatever the indication, able to act on their ventilator, and in stable state on the respiratory level for at least 3 months. exclusion criteria: * subjects taking treatment that may interfere with sleep patterns * intake of alcohol or any substance (alcohol, drugs) that may interfere with sleep patterns the day before the polysomnography
effect of a lateral wedge insole and simple knee sleeve in individuals with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the focus of this project is to determine the immediate efficacy of a combined treatment (lateral wedge insole + simple knee sleeve) in individuals with knee osteoarthritis (oa) and the short term effect over 6 weeks. secondly, to compare the effect of this combined treatment with each treatment on its own (lateral wedge insole, simple knee sleeve)


Eligibility criteria:
inclusion criteria: * 1- mild knee pain during walking on flat surface diagnosis via koos questionnaire (3 out of 10) because our aim of the study to reduce pain with combined treatment and pain lower than 3 out of 10 score might not allow to compared the pain reduction between the group. 2- definitive medial joint narrowing higher or equal to the lateral side and osteophytes on x-ray a-p or pa view in weight bearing position if possible. 3- medial joint tenderness either by patient's indication or the clinician under the clinical examination indicating tenderness in the tibiofemoral joint. 4- k-l grade 2 or 3 of plain radiographs. if the patient has had arthroscopy or mri as their usual clinical care. indication of grade 1 osteoarthritis pulse the radiological plain x-ray will be used. 5- being able to walk without assisted devices for 100 meters non-stop because he or she will not be able to complete this study protocol. exclusion criteria: * 1- more pain localized to patellpfemoral or lateral joint than the medial knee side on examination. 2- tricompartmental knee osteoarthritis. 3- k-l grade 4 or higher. 4- neurological or orthopaedic situations known to affect the ability to walk. 5- tibial osteotomy or any other realignment operation. 6- total knee replacement. 7- any condition contraindicates orthosiss (sleeve or insole) use. 8- steroid injection to affected intra-articular knee joint space in the previous month. 9- previous or current use of any oththosis. 10- participants with 30 bmi and higher will be excluded because previous study showed that individuals with 33 bmi. 11- lower than 35 years and higher than 85 as this period was identified to highest incidence period (losina et al., 2013). although individuals with 86 and higher has high prevalence to the knee oa, exclusion this population was important due to high amount of walking and balance test.
a study to assess the absorption of a single dose of bms-986205 in healthy volunteers when administered as a crushed tablet orally or crushed tablet suspension via nasogastric tube, as compared to a tablet

Conditions: Healthy Volunteers

Summary: the purpose of this study is to evaluate the absorption of bms-986205 into the bloodstream of healthy volunteers, when administered as an intact tablet taken orally, or as a crushed tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric (ng) tube. eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive a single dose of bms-986205 twice during the course of the study.


Eligibility criteria:
inclusion criteria: * signed written consent form. * healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ecgs (electrocardiograms) and clinical laboratory determinations. * women participants must have documented proof they are not of childbearing potential. * males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with bms-986205, and for a total of 110 days after the last dose of bms-986205; and must be willing to refrain from sperm donation during this time. azoospermic males are exempt from contraceptive requirements. * normal renal function at screening (glomerula filtration rate ≥ 80 ml/min/1.73 m2). * body mass index (bmi) of 18.0 kg/m2 to 32.0 kg/m2 inclusive. exclusion criteria: * women who are of childbearing potential or breastfeeding. * any significant acute or chronic illness. * active tuberculosis (tb) requiring treatment, documented latent tb within the previous 3 years, or evidence of a past tb infection without documented adequate therapy. all participants will be required to have a quantiferon -tb gold test performed at screening. * history of glucose-6-phosphate dehydrogenase deficiency (g6pd) or any other congenital hemolytic anemias. * history of cardiac arrhythmias and/or autonomic instability. * history of pulmonary, renal or liver disease. * history of gilbert's syndrome. * recent (within 6 months of study drug administration) history of smoking or current smokers, including use of electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum. * participants with active, known or suspected autoimmune disease. participants with vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may enroll. * major surgery within 4 weeks of study drug administration. other protocol defined inclusion/exclusion criteria could apply.

Keywords: healthy participants healthy subjects
phase ii pilot study of vincristine, adriamycin, actinomycin d, ifosfamide combination chemotherapy in ewing's sarcoma

Conditions: Ewing's Sarcoma

Summary: phase ii pilot study of vincristine, adriamycin, actinomycin d, ifosfamide combination chemotherapy in ewing's sarcoma


Eligibility criteria:
inclusion criteria: * patients with ewing's sarcoma
impact of dialysis modality on hepcidin and iron metabolism

Conditions: End-stage Renal Disease

Summary: * dialysis modality may influence the oxidative stress and proinflammatory cytokines in esrd patients. * dialysis modality may affect hepcidin * dialysis modality may influence iron and esa requirements.

it has been considered that pd patients tended to be less anemic and require lower esa dose than hd patients. in addition, it was also known that the level of oxidative stress and inflammatory cytokines tended to be lower in pd patients than hd patients. and hepcidin synthesis is markedly increased during inflammation. altogether, lower esa requirement in pd patients may be associated with lower hepcidin level due to lower inflammatory state compared with hd patients.

Eligibility criteria:
inclusion criteria: * written informed consent * age 18 years or older * dialysis treatment was expected over 3 months * in hd patients, regular hemodialysis 4 h a session more than two times a week * in pd patients, over 2 exchange with more than 1.5 l solution exclusion criteria: * poorly controlled hypertension, i.e. sitting blood pressure exceeding 180/110 despite medication requiring hospitalization or interruption of esa treatment * significant acute or chronic bleeding such as overt gastrointestinal bleeding within the previous 3 months * active malignant disease (except non-melanoma skin cancer and patients with malignant disease who have been disease-free for at least the 5 previous years are eligible) * acute infection * hemolysis * hemoglobinopathies (e.g. homozygous sickle-cell disease, thalassemia of all types) * megaloblastic anemia * platelet count \>500 x 109/l or \<100 x 109/l * pure red call aplasia * epileptic seizure during previous 3 months * women of childbearing potential without effective contraception * known hypersensitivity to recombinant human erythropoietin, polyethylene glycol * planned elective surgery during the study period except for cataract surgery or laser photocoagulation * life expectancy less than 12 month

Keywords: hepcidin esa hemodialysis peritoneal dialysis iron metabolism dialysis modality
pilot study- treat to target vitamin d in end stage renal disease

Conditions: Chronic Kidney Diseases

Summary: feasibility of dose adjustment to reach a 6 month 25-hydroxy vitamin d level of 35-50 ng/ml in end stage renal disease patients

pilot study to test the feasibility of adjusting doses based on a prespecified algorithm to reach a 6 month 25(oh)d level of 35-50 ng/ml in end stage renal disease patients.

Eligibility criteria:
inclusion criteria: * likely be able to complete the study, \>3 months on hemodialysis, receiving standard of care through their nephrologist. exclusion criteria: * on peritoneal dialysis, allergy to vitamin d, liver disease, intestinal disorders that interfere with vitamin d absorption, taking vitamin d \>800 iu per day, 25(oh)d level \>30 ng/ml, glucocorticoids, anticonvulsants or drug therapies for osteoporosis, pregnancy.
research on the risk warning model and prevention strategies for acute kidney injury associated with cyclosporine based on explainable deep neural networks and therapeutic drug monitoring

Conditions: AKI; Therapeutic Drug Monitoring (TDM)

Summary: in this study, the investigators will focus on hospitalized patients using cyclosporine and develop an acute kidney injury risk prediction model through in-depth analysis of electronic medical record data, employing interpretable deep learning methods. this model aims to provide timely decision-making support for clinicians regarding prevention and treatment. compared to traditional machine learning models, deep neural network models can extract deeper features from complex medical data and perform more precise pattern recognition, thereby improving the accuracy and reliability of predictions. by developing a prediction tool based on interpretable deep learning models, the investigators will be able to better assess the association between the use of cni-class immunosuppressants and acute kidney injury, explore targeted prevention strategies, and offer more accurate prediction and intervention guidance for clinicians. additionally, this study has significant socioeconomic benefits and promising prospects for application and promotion.


Eligibility criteria:
inclusion criteria: 1. during hospitalization, tacrolimus or cyclosporine was used, and therapeutic drug monitoring was conducted according to standard procedures. 2. aged 18 years or older at the time of admission. 3. length of hospital stay \&gt; 48 hours. 4. at least 2 serum creatinine tests were conducted during hospitalization. exclusion criteria: 1. chronic kidney disease stage 5 was achieved before admission. 2. incomplete clinical data. 3. serum creatinine levels were consistently below 40 mmol/l during hospitalization.

Keywords: deep learning aki adm
investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted globally. the aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.


Eligibility criteria:
inclusion criteria: - informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial - male or female, age 18 years or older at the time of signing inform consent - body mass index (bmi) equal or above 30.0 kg/m\^2 at the screening visit - at least one unsuccessful weight loss attempt per investigator judgement exclusion criteria: - a hba1c (glycosylated haemoglobin) equal to or above 6.5% at screening or diagnosed with type 1 or type 2 diabetes mellitus - treatment with glucose lowering agent(s) within 90 days before screening - screening calcitonin equal to or above 50 ng/l (pg/ml) - personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 - history of pancreatitis (acute or chronic) - obesity induced by endocrine disorders (e.g. cushing syndrome) - treatment with any medication within 90 days before screening that based on investigator's judgement may cause significant weight change - previous surgical treatment for obesity (liposuction and/or abdominoplasty performed 1 year before screening is allowed) - history of major depressive disorder within 2 years before randomisation - any lifetime history of a suicidal attempt - female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
digital therapeutic vs educational app for depression among adolescents

Conditions: Depression

Summary: the primary aim of this study is to investigate the difference in depression symptoms at 4-weeks across two types of programs for addressing depressive symptoms, including woebot (wb002) and digital education (ed002). the secondary aim of this study is to investigate the difference in anxiety symptoms at 4-weeks across the two programs. the tertiary aim of this study is to evaluate the feasibility, acceptability, and satisfaction of each program.


Eligibility criteria:
inclusion criteria: 1. be 13-17.5 years of age 2. be a u.s. resident 3. able to read and write in english 4. if currently on medication: regular, stable dose of antidepressant medications (e.g., escitalopram/lexapro, fluoxetine/prozac) for at least 60 days at screening 5. if currently receiving psychotherapy: must be in therapy for at least 4 weeks at screening 6. own or have regular access to a smartphone (operating systems: android 6 or later and ios 13 or later) that can receive sms messages, and has reliable wi-fi access or sufficient data to engage with study app 7. available and committed to engage with the program for a 8-week duration and complete assessments 8. participants must be able to understand and willing to provide informed assent and to comply with all study procedures and restrictions 9. willingness to provide parent/guardian contact information to provide econsent and participate in clinical interviews exclusion criteria: 1. phq-a score less than 10 2. lifetime diagnosis of a psychotic disorder (including schizophrenia or schizoaffective disorder) 3. lifetime diagnosis of bipolar disorder 4. lifetime diagnosis of autism spectrum disorder or pervasive developmental disorder (e.g., asperger syndrome, rett's syndrome, or pervasive developmental disorder not otherwise specified) 5. current (past year) diagnosis of a substance use disorder 6. suicide attempt or suicidal ideation with plan and intent within the past 12 months 7. previous woebot application use 8. enrollment of more than one member of the same household

Keywords: mental health adolescent digital therapeutic chatbot mental health app