Kornimate/medical-research-clean huggingface dataset:
efficacy of trial-based cognitive therapy and behavioral activation in treatment of depression

Conditions: Major Depressive Disorder

Summary: major depressive disorder (mdd) is a mood disorder, highly prevalent in brazil and in world. the treatments of choice are the psychotropic drugs of the class of antidepressants and behavioral or cognitive behavior therapy (cbt). the aim of this study is to compare the efficacy of trial based cognitive therapy with the behavioral activation and pharmacotherapy in the treatment of mdd in a randomized clinical trial witch 96 patients with mdd,

major depressive disorder (mdd) is a mood disorder, highly prevalent in brazil and in world. mdd is associated with an impaired quality of life and socio occupational functions. the treatments of choice are the psychotropic drugs of the class of antidepressants and cognitive behavior therapy (cbt). some of the patients with pharmacotherapy alone still symptomatic. this explains the association between psychotherapy and pharmacotherapy. the cbt seek to modify thoughts, emotions and behaviors and have shown efficacy in several mental disorders, including mdd. among the cbt models, there is an emphasis on interventions that emphasize: 1) the modification or restructuring of thoughts and beliefs. in this point, the trial based cognitive therapy (tbcp) is an approach with a particular emphasis on the modification of core beliefs ; 2) the direct modification of behavior, such as the behavioral activation (ba) that analyzes contingencies and encourages the implementation of activities to improve mood. this project aims to compare the efficacy of tbcp with the ba in the treatment of mdd. for this, a randomized clinical trial will be conducted to treat 96 patients with mdd who are in drug treatment, which will be drawn to the interventions of tbcp most psychiatric drugs, ba more psychiatric drugs or pharmacotherapy alone, each group with 32 patients. patients will be evaluated with scales and inventories to assess depression, quality of life and social functioning, and the data will be statistically compared between groups.

Eligibility criteria:
inclusion criteria: * major depressive disorder * both genres * minimum of 20 in bdi score * refractory depressive disorder exclusion criteria: * bipolar disorder * high risk of suicide * borderline personality

Keywords: major depressive disorder cognitive behavioral therapy trial based cognitive therapy behavioral activation
a study to evaluate eras-801 in patients with recurrent glioblastoma (thunderbbolt-1)

Conditions: Glioblastoma Multiforme

Summary: * to evaluate the safety and tolerability of escalating doses of eras-801 in study participants with recurrent glioblastoma multiforme (gbm). * to determine the maximum tolerated dose (mtd) and/or recommended dose (rd) of eras-801. * to evaluate the antitumor activity of eras-801. * to evaluate the pk profile of eras-801.

this is a phase 1, open-label, multicenter clinical study evaluating eras-801 as a monotherapy. the study will initially commence with dose escalation of eras-801 in study participants with recurrent gbm. once the mtd and/or rd has been determined from dose escalation, then dose expansion of eras-801 may commence in study participants with recurrent gbm harboring alterations in epidermal growth factor receptor (egfr).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * willing and able to give written informed consent * diagnosis of glioblastoma, idh wt as defined by the who 2021 criteria * adequate organ function * willing to comply with all protocol-required visits, assessments, and procedures * able to swallow oral medication exclusion criteria: * prior treatment with an egfr inhibitor for glioblastoma * currently enrolled in another therapeutic study * history of clinically significant cardiovascular disease * gastrointestinal conditions that may affect administration/absorption of oral medications * have an active infection (bacterial, fungal, or viral) requiring systemic therapy * pregnant or breastfeeding women * any serious underlying medical or psychiatric condition or evidence of any other significant clinical disorder or laboratory finding that renders the patient inappropriate to participate in the study * known allergies, hypersensitivity, or intolerance to eras-801 or its excipients

Keywords: gbm egfr epidermal growth factor receptor alteration erbb1
vitamin d and vascular health in children

Conditions: Obesity; Vitamin D Deficiency

Summary: in this study, we will test the central hypothesis that enhancement of vitamin d status in obese and overweight children will improve their vascular health and their cardiovascular disease (cvd) and metabolic syndrome risk profile.

our primary objective is to determine, in obese and overweight children aged 10 to 18 years with vitamin d deficiency (defined as serum 25-hydroxyvitamin d \<20 ng/ml), the efficacy of enhanced vitamin d3 supplementation in improving vascular endothelial function, arterial stiffness, insulin sensitivity, and metabolic syndrome risk status; and to assess whether these effects are dose-dependent. as a secondary objective, we will examine the vitamin d supplementation-induced effect on adipokines and inflammatory markers relevant to cvd risk. in a double-masked, controlled trial, we will randomize 252 eligible children to receive either 600 iu (conventional supplementation), or 1000 iu or 2000 iu (enhanced supplementation) of vitamin d3 daily for 6 months. in terms of reporting of results, the following pre-specified outcomes are included in the primary manuscript (pubmed pmid:31950134 -- see reference section for citation details) 1. waist circumference 2. serum high density lipoprotein (hdl) cholesterol 3. serum triglycerides 4. inflammatory markers (plasma tnf-alpha, high-sensitivity c-reactive protein, and il-6) 5. adiopkines (plasma leptin and adiponectin) plasma nitric oxide metabolites were not measured.

Eligibility criteria:
inclusion criteria: * eligible subjects will be 10 to 18 years of age; * obese or overweight (bmi ≥85th %tile); * otherwise healthy, and * have a serum 25(oh)d concentration \<20 ng/ml children taking multivitamins should be able to hold off their multivitamins during the course of the study. exclusion criteria: children will be excluded if they * (a) have hepatic or renal disease, metabolic rickets, malabsorptive disorders, primary hyperparathyroidism, hyperthyroidism, or other chronic disorders that could affect vitamin d metabolism; * (b) are receiving treatment with anticonvulsants, systemic glucocorticoids, pharmacologic doses of vitamin d (≥1000 iu of vitamin d2 or d3 daily), antihypertensives, vasoactive drugs, antilipidemics, metformin, antipsychotics, or other oral insulin regulators; * (c) have cholelithiasis or urolithiasis; * (d) have type 1 or type 2 diabetes; or * (e) have a condition or underlying abnormality that could compromise the safety of the subject. post-menarchial girls with a positive pregnancy test at randomization, or subjects found during the screening phase to have hypercalcemia (serum calcium \>10.8 mg/dl) or significant fasting hyperglycemia (fasting blood glucose ≥ 125 mg/dl) will also be excluded.

Keywords: obesity vitamin d deficiency vascular function insulin resistance metabolic syndrome
extracellular rna biomarkers of myotonic dystrophy

Conditions: Myotonic Dystrophy

Summary: current methods of measuring the response to new treatments for muscular dystrophies involve the examination of small pieces of muscle tissue called biopsies. the investigators are interested in finding less invasive methods that reduce the need for muscle biopsies. the purpose of this research is to learn about the possibility of detecting and measuring the activity and severity of muscular dystrophies by examining a urine sample and a blood sample.


Eligibility criteria:
inclusion criteria: * subjects with dm1 or dm2 based on genetic testing and/or clinical criteria (some subjects who have positive genetic testing may be asymptomatic, while other subjects who show characteristic clinical features may have declined to have genetic testing done). control non-dm subjects are unknown to have dm or any other muscular dystrophy by history and may have had no genetic testing. * able to provide informed consent or assent for participation in the study. * demographic characteristics for single biofluid collection: males and females age 5 years and older (dm1, dm2, and non-dm). * demographic characteristics for repeated measurements: males and females age 14 years and older with dm1. * demographic characteristics for biofluid and muscle biopsy: males and females, ages 18-65 years. exclusion criteria: * medical history of any of the following. state of immunosuppression; coagulopathy; pre-existing liver or kidney disease; documented hiv positive; documented hepatitis b and/or c positive. * medications and other drugs. use of anti-platelet drugs within 7 days prior to blood draw or biopsy; use of anticoagulants within 60 days prior to blood draw or biopsy; active drug or alcohol use or dependence that, in the opinion of the biopsy surgeon, would interfere with post-procedure wound care. * other. women that are pregnant, or intend to become pregnant, prior to the biopsy; urine pregnancy test that is positive; inability or unwillingness of the subject to give written informed consent. * other. inability or unwillingness of the subject to give written informed consent or assent.
first-in-human trial of anti-adamts-5 nanobody in healthy volunteers

Conditions: Healthy

Summary: this first-in-human trial will be conducted in healthy male subjects to explore the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of single doses of m6495.


Eligibility criteria:
inclusion criteria: * subjects with body mass index (bmi) of greater than or equal to (\>=) 18.5 and less than or equal to (=\<) 29.9 kilogram per square meter (kg/m\^2), and a body weight between 50 and 100 kg at screening. * subjects must agree to use effective method(s) of contraception during the trial. * other protocol defined inclusion criteria could apply. exclusion criteria: * subjects who have recently participated in other clinical trials. * donated blood, have a significant medical condition, history of drug hypersensitivity, consumption of large amounts of xanthine-containing foods or beverages, recent or ongoing concomitant medication, hypertension, tachycardia and significant findings on electrocardiogram * positive drug screening test, positive test for hepatitis b or c or human immune deficiency virus (hiv), or have been kept in detention * other protocol defined exclusion criteria could apply.

Keywords: m6495 anti-a disintegrin and metalloproteinase with thrombospondin motifs-5 nanobody osteoarthritis
dietary supplement of lehel for the patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: due to metabolic disorders and dietary restrictions, patients with diabetes may have different degrees of malnutrition. the primary objective of this study is to investigate whether supplementation of lehel, a multi-nutrients supplement, is capable to improve metabolic parameters in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * subject is diagnosed with type 2 diabetes mellitus according to the chinese type 2 diabetes prevention guide 2010, diagnostic criteria are as follows: (1) diabetes symptoms（polydipsia、polyphagia, polyuria, weight loss、skin itching、blurred vision and other acute metabolic network disorder that caused by high blood sugar）combined with random blood sugar ≥11.1 or, (2) fasting plasma glucose (fpg) ≥7.0 or, (3) 2 h blood sugar after oral glucose tolerance test (ogtt) ≥11.1; * subject is between 18 and 75 years of age, inclusive. * subject's bmi is \>18.5 kg/m2 and \<35 kg/m2. * if on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit. exclusion criteria: * subject that is diagnosed as type 1 diabetes, gestational diabetes and other kinds of diabetes expect type 2. * subject that use exogenous insulin for glucose control. * subject that has a history of diabetic ketoacidosis. * subject that has mental disorder, cancer, cirrhosis, renal disease and hepatic disease. * subject that has had a significant cardiovascular event less than six months prior to screening visit or has history of congestive heart failure. * subject that has had operation less than six months prior to screening visit. * subject that has taken/is currently taking any dietary supplements or medications that could profoundly affect blood glucose during the past one month prior to screening visit. * subject is known to be allergic or intolerant to any ingredient found in the study product.

Keywords: malnutrition; metabolic disorders
rituximab plus combination chemotherapy in treating patients with hiv-related non-hodgkin's lymphoma

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. combining rituximab with chemotherapy may kill more cancer cells. purpose: phase i trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have hiv-related non-hodgkin's lymphoma.

objectives: * determine the response rate of patients with poor-prognosis, hiv-related non-hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin. * determine the toxicity of this regimen in these patients. * determine the time to progression and survival of patients treated with this regimen. outline: this is a multicenter study. patients receive chemotherapy comprising vincristine iv and bleomycin iv on day 1 and oral prednisolone every other day beginning on day 1. treatment repeats every 3 weeks for 6 courses. patients also receive rituximab on days 14, 21, 28, and 35. patients who achieve complete response (cr) receive 2 additional courses of chemotherapy after cr. patients are followed every 1-2 months. projected accrual: a total of 10-20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of poor-prognosis, hiv-related non-hodgkin's lymphoma (hiv-nhl) * previously untreated * more than 1 of the following criteria: * prior diagnosis of aids * ecog performance status 3-4 * cd4 count less than 100/mm3 * no primary cerebral lymphoma patient characteristics: age: * 18 and over performance status: * see disease characteristics life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy for hiv-nhl * at least 1 year since prior chemotherapy for kaposi's sarcoma (ks) endocrine therapy: * not specified radiotherapy: * prior radiotherapy for hiv-nhl allowed * at least 1 year since prior radiotherapy for ks surgery: * not specified

Keywords: aids-related peripheral/systemic lymphoma aids-related diffuse large cell lymphoma aids-related immunoblastic large cell lymphoma aids-related small noncleaved cell lymphoma aids-related diffuse mixed cell lymphoma aids-related diffuse small cleaved cell lymphoma aids-related lymphoblastic lymphoma
constraint induced movement therapy (cimt) in babies home program

Conditions: Hemiplegia; Cerebral Palsy

Summary: the research objectives are to test the efficacy of a modified cimt treatment in babies diagnosed with hemiplegia, treated in a home program, as compared to a control group of babies receiving a parallel home program but with no cimt.


Eligibility criteria:
inclusion criteria: * babies age 7-18 months diagnosed with hemiplegic cerebral palsy exclusion criteria: * epilepsy not treated
pilot study examining effect for dextroamphetamine to treat cocaine dependence plus attention-deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Disorder With Hyperactivity; Cocaine-Related Disorders; Substance-Related Disorders

Summary: dextroamphetamine is commonly used to treat adhd, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and adhd.

this double-blind, placebo-controlled pilot study will determine the ability of dextroamphetamine to treat comorbid cocaine dependence and adhd. participants will be randomly assigned on receive placebo or dextroamphetamine sr (60 mg/day) during a 12-week study period. all participants will receive weekly cognitive behavioral therapy.

Eligibility criteria:
inclusion criteria: * provide informed consent * generally good health except for problems related to drug use * meet dsm criteria for cocaine dependence and adhd * have stable living situation exclusion criteria: * dsm diagnosis for current psychotic, anxiety disorders as well as current substance dependence (with the exception of marijuana and nicotine) * current use of prescription medications * females who are currently pregnant or nursing * history of significant acute or chronic physical illness * history of or current liver disease * existing cardiovascular disease * plans to leave metropolitan area within 3 months * probation or parole with constraints that preclude full study participation

Keywords: cocaine adhd attention hyperactivity drug dependence
a comparative study of prophylactic anticoagulation in meningioma surgery

Conditions: Meningioma

Summary: the aim of the study is to compare different strategies for prevention of venous thromboembolism related to intracranial meningioma surgery. the investigators identified three hospitals where two have a very restrictive approach with respect to anticoagulant therapy while at the third hospital the use of anticoagulation the day before surgery was initiated as routine prophylaxis. based on this "natural experiment" it will be explored whether the use of anticoagulant prophylaxis is associated with reduced risk of venous thromboembolism and/or associated with increased risk of postoperative hemorrhage as compared to the 2 cohorts where this intervention were absent.


Eligibility criteria:
inclusion criteria: * first included patient 1.january 2007 and latest included patient 1.july 2013 (allows for 30 day follow up with respect to morbidity) * histological verification of a meningioma (of any grade) from the current surgery exclusion criteria: * intracranial surgery or venous thromboembolism the last 3 months

Keywords: surgery enoxaparin venous thromboembolism perioperative care
racial differences in the natriuretic peptide response to glucose challenge

Conditions: Healthy; Natriuretic Peptides; Metabolic Syndrome

Summary: the purpose of the study is to discover any racial dissimilarity in the response of natriuretic peptide (np) system to acute metabolic influences such as a high carbohydrate challenge

previous studies have shown an association between reduced levels of circulating natriuretic peptides (nps) and obesity in humans. this association is especially pronounced in those with metabolic syndrome traits and elevated plasma insulin. as previously conducted study has shown that an increase in nps with weight loss in obese individuals is "primary" and not secondary to alteration in cardiac structure or function. previous experimental data suggests that atrial np (anp) has a wide range of favorable metabolic effects including that activation of brown fat and improvement in skeletal muscle oxidative capacity and glucose utilization. new evidence suggests that anp activation directly modulates insulin sensitivity and energy homeostasis, suggesting that anp suppression could promote more obesity/insulin resistance. moreover, anp exerts potent lipolytic effects in vitro and in vivo. the previous study has shown that a high-carbohydrate challenge in healthy volunteers is associated with a reduction in n-terminal-proanp (ntproanp) but not n-terminal-prob-type np (ntprobnp) levels. nonetheless our outcomes were predominantly in caucasians and warrants replication in other racial groups. there is no data on the anp response to high-carbohydrate challenge in african americans, a racial group with disproportionately greater rates of obesity, insulin resistance, and diabetes as compared to caucasians. so the investigators have proposed to conduct a pilot study in otherwise healthy, normotensive subjects to examine np system, especially the effects on mrproanp in response of high-carbohydrate challenge.

Eligibility criteria:
inclusion criteria: * age 18-40 years * blood pressure less than 140/90 * estimated creatinine clearance \>60cc/min * willingness to comply with the study diet exclusion criteria: * history of hypertension * history of cardiovascular, renal, or liver disease * diabetes or use of glucose-lowering medications * use of vasoactive or diuretic medications * atrial fibrillation * anemia (hematocrit \< 41% in men and \<35% in women * abnormal serum sodium or potassium * urine β-hcg consistent with pregnancy * abnormal liver function tests (\>3x upper limit of normal) * women taking hormonal birth control * current smokers * regular users of non-steroid anti-inflammatory medications

Keywords: racial differences
evidence based management of acute biliary pancreatitis

Conditions: Acute Pancreatitis

Summary: this study aims to assess the outcome of standardized evidence-based care to all patients with acute biliary pancreatitis treated at surgery department, zagazig university hospitals during the period from may, 2017 to may 2019.

acute pancreatitis (ap) is one of the most important gastrointestinal disorders causing emotional and physical human burden . the annual incidence worldwide for ap is 4.9-73.4 cases per 100,000 people and the overall mortality rate is 4 to 8%, which increases to 33% in patients with infected necrosis. ap is diagnosed when two of three criteria are fulfilled: typical abdominal pain of ap, more than three times elevated serum amylase/lipase level and signs of ap on imaging. it is necessary to clarify the etiology of ap promptly. the diagnosis of gallstones, as the leading cause for ap, should have the top priority as that will direct the treatment policy. long standing alcohol consumption and gallstones disease incriminated in the majority of cases with ap. small common bile duct stones, in particular, are the cause of ap in approximately 32 to 40% of cases. in 10-30% of cases, the cause is unknown, so studies have suggested that up to 70% of cases of idiopathic pancreatitis are secondary to biliary microlithiasis. the pathogenesis of biliary ap has been intensively investigated. many theories explain how gallstones can trigger ap. the predominant theories include common pathway theory and gallstone migration theory. in general, ap occurs when intracellular protective mechanisms fail to prevent trypsinogen activation or reduce trypsin activity. it is important that management of such potentially life threatening condition to be guided by an evidence-based approach. after comparing the japanese (jpn) guidelines 2015 and its former edition 2010 with the other two guidelines, international association of pancreatology/american pancreas association guidelines (iap/apa), 2013 and american college of gastroenterology (acg), 2013, the jpn guidelines, 2015 proved to be the highest quality regarding its systematic literature review prepared by the meta-analysis team, including the grading of recommendations and providing pancreatitis bundles.

Eligibility criteria:
inclusion criteria: * all cases with acute biliary pancreatitis exclusion criteria: * all cases with non biliary pancreatitis

Keywords: acute pancreatitis guidelines acute biliary pancreatitis