Kornimate/medical-research-clean huggingface dataset:
effectiveness of neurapas balance in children with nervous restlessness

Conditions: Nervousness; Restlessness; Depression (Agitated); Affective Disorders

Summary: purpose: to document data on effectiveness of neurapas® balance (npb) in the treatment of nervous restlessness in children aged 6 to 12. each patient is treated with npb. no placebo group is established. course and severity of symptoms is documented by a questionnaire on 13 common symptoms of nervous restlessness and a visual analogue scale (vas). a standardized questionnaire (parent child behaviour checklist (cbcl/4-18)) is completed. choice and doses of therapy are at the respective physician's discretion. the planned treatment and observation period is 2 - 4 weeks.

purpose: to document data on effectiveness of neurapas® balance (npb) in the treatment of nervous restlessness in children aged 6 to 12. patients and methods: a prospective, non-interventional, non-randomized, observational study conducted in german pediatric practices. each patient is treated with npb. no placebo group is established. as subjective criteria to document course and severity of symptoms, a questionnaire on 13 common symptoms of nervous restlessness and a visual analogue scale (vas) is used. as an objective criterion, a standardized questionnaire (parent child behaviour checklist (cbcl/4-18)) is completed. choice and doses of therapy are at the respective physician's discretion. the planned treatment and observation period is 2 - 4 weeks.

Eligibility criteria:
due to the design as an observational study no inclusion or exclusion criteria are named. the included patient group is described under "cohort / group". observational criteria: * age 6 - 11 (extremes included) * nervous restlessness and/or * agitated depression and/or * affective disorders exclusion criteria: * patients \ 12 years of age

Keywords: nervousness restlessness depression affective disorder
effects of dapagliflozin on insulin resistance and insulin secretion in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effects of dapagliflozin on insulin sensitivity


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes and inadequate glycemic control, defined as a1c ≥ 7.0 and ≤ 10.0% at the enrollment visit * subjects should have been receiving either metformin therapy or metformin therapy and one insulin secretagogue for at least 12 weeks prior to enrollment * c-peptide ≥ 1.0 ng/ml (0.34 nmol/l) * bmi ≤ 45.0 kg/m2 exclusion criteria: * urine albumin to creatinine ratio (uacr) \> 1,800 mg/g (203.4 mg/mmol/cr) * aspartate aminotransferase (ast) \> 3x upper limit of normal (uln) * alanine aminotransferase (alt) \> 3x uln * serum total bilirubin \> 2 mg/dl (34.2 μmol/l) * serum creatinine (scr) ≥ 1.50 mg/dl (133 μmol/l) for men; scr ≥ 1.40 mg/dl (124 μmol/l) for women * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
enhanced medical rehabilitation in older adults

Conditions: Disabling Medical Events; Disabled; Depression

Summary: the purpose of this study is to provide evidence that enhanced medical rehabilitation is an effective treatment for older adults after disabling medical events.

the intervention involves physical and occupational therapy for patients who have been admitted to a skilled nursing facility for therapy following a disabling medical event. participants in this study will be randomly assigned to receive either enhanced or standard of care therapy, meaning they will either receive their pt (physical therapy)\& ot(occupational therapy) from therapists who have been specially trained in the study intervention or from therapists with normal training. participants will be assessed at baseline, 30, 60, and 90 days after baseline, and at the date of their discharge from the skilled nursing facility.

Eligibility criteria:
inclusion criteria: * 65 and older * admitted to a skilled nursing facility for post-acute care from pt and ot for 2 weeks or more. exclusion criteria: * language, visual or hearing barriers to participation * medical illness preventing study participation or accurate data collection * moderate-severe dementia (demonstrated by chart diagnosis and/or short blessed score greater than 13) * progressive neurological condition such that recovery of function is not feasible * patient did not have the ability to walk prior to hospitalization (e.g. paraplegic) * schizophrenia or other chronic or current psychotic disorder.

Keywords: physical therapy occupational therapy rehabilitation older adults depression physical functioning
safety of cultured allogeneic adult umbilical cord stem cells for peyronie's disease, ed, and interstitial cystitis

Conditions: Erectile Dysfunction; Peyronie's Disease; Interstitial Cystitis

Summary: this trial will study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of peyronie's disease, erectile dysfunction , and interstitial cystitis

this patient funded trial aims to study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (uc-mscs) for the treatment of peyronie's disease, erectile dysfunction , and interstitial cystitis. the total dose will be 100 million cells. patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria:
inclusion criteria: * diagnosis of peyronie's disease, erectile dysfunction, or interstitial cystitis * understanding and willingness to sign a written informed consent document exclusion criteria: * active infection * active cancer * chronic multisystem organ failure * pregnancy * clinically significant abnormalities on pre-treatment laboratory evaluation * medical condition that would (based on the opinion of the investigator) compromise patient's safety. * continued drug abuse * pre-menopausal women not using contraception * previous organ transplant * hypersensitivity to sulfur

Keywords: erectile dysfunction peyronie's disease stem cell treatment interstitial cystitis
dose-ranging study to evaluate efficacy of slv339 in pancreatic exocrine insufficiency due to chronic pancreatitis

Conditions: Pancreatic Exocrine Insufficiency Due to Chronic Pancreatitis

Summary: this study is to estimate the efficacy of a number of doses in patients with pancreatic insufficiency


Eligibility criteria:
inclusion criteria: * subject \> 18 years; * pancreatic exocrine insufficiency confirmed and documented in medical history by either a pathophysiological direct or indirect pancreatic function test or clinical symptoms of steatorrhea stool fat that resolved or improved substantially upon pancreatic enzyme supplementation; * patients on a stable daily dose of pancreatic enzymes for 3 months; * subjects with cp with or without partial pancreatectomy due to cp, confirmed in medical history by either ct , ercp, plain film with pancreatic calcifications, ultra-sonography (calcifications, duct dilatation), magnetic resonance pancreatography, endoscope ultrasound, other radiological diagnosis captured by tools such as cambridge classification and /or histology; * cfa \< 80% at time of randomization exclusion criteria: * evidence of major surgery (except gall bladder removal or appendectomy) or other relevant diseases as revealed by history, physical examination, and laboratory assessments which may interfere with the absorption, distribution, metabolism or elimination of the study drug or constitute a risk factor when taking the study medication; * investigational drug intake within 90 days prior to the pre-assessment visit; * ileus or acute abdomen; * allergic disease such as hypersensitivity pneumonitis, aspergillus mediated asthma or allergic broncho-pulmonary aspergillosis; * stenosis or regurgitation of the esophagus or stomach; * known hiv infection, acute phase of cp

Keywords: pancreatic exocrine insufficiency chronic pancreatitis
68ga dotatate pet/ct in neuroendocrine tumors (expanded access)

Conditions: Carcinoid Cancer; Neuroendocrine Tumors; Medullary Thyroid Cancer; Cancers Expressing Somatostatin Receptors

Summary: to evaluate 68ga-dotatate pet/ct for staging of patients with carcinoid, neuroendocrine tumors, medullary thyroid cancer and other cancers expressing somatostatin receptors.

this is an expanded access study with a total of 300 participants with net and suspected sstr positive tumors. eligible participants will undergo baseline assessments at enrollment. study participants will receive 68ga-dotatate and will undergo a pet/ct imaging study. all patients referred by oncologists will be screened by a ucla nuclear medicine physician and then accepted for scanning if clinically appropriate.

Eligibility criteria:
inclusion criteria: * older than 18 years the time of radiotracer administration * provides written informed consent * known diagnosis of net or suspected sstr positive tumors women of childbearing age must have a negative pregnancy test at screening/baseline * able to remain still for duration of each imaging procedure (about 30 minutes) exclusion criteria: * less than 18 years-old at the time of radiotracer administration * pregnant or nursing * inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.) * any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the investigator, may significantly interfere with study compliance.
low calorie diet in morbidly obese patients

Conditions: Obesity

Summary: this is a prospective study of morbidly obese patients that are planned to conduct bariatric surgery. the patients included in the study will conduct a low-calorie diet for 6 days prior to the operation and be admitted to hospital for this period. on admission and after finishing the diet a number of tests will be performed: weigh, height, oral glucose tolerance test, bioimpedance measurement, and samples of blood, urine and a biopsy of subcutaneous adipose tissue.

the study will include 14 patients planned for bariatric surgery with bmi 40-46. the patients will be admitted to hospital 8 days prior to planned surgery and conduct a diet based mostly on fluids (yogurt, soups). estimated daily calorie intake will be 400-600 kcal. at the day of admission and at day 7 a number of tests will be performed including blood tests, urine test and biometric measurement and a biopsy of subcutaneous adipose tissue. weight will be measured every morning for the study period. during the operation fatty tissue samples will be taken subcutaneous and from the omentum major. this study is planned as a control group to another study where blood tests and subcutanous adipose tissue was sampled before and 6 days after bariatric surgery. the main aim of this study is to compare changes in adipose tissue and blood samples for patients before and 6 days after surgery to before and 6 days after a low-calorie diet.

Eligibility criteria:
inclusion criteria: * bmi 40-46 kg/m2 * the patients must not conduct a diet before admission. * fasting blood glucose \<-7 nmol/l exclusion criteria: * diabetes mellitus * treatment with antidiabetics * allergy for substances in the planned study-diet
effect of vitamin d3 supplementation on muscle mass in icu patient

Conditions: Vitamin D Deficiency; Sarcopenia; Critical Illness

Summary: a randomized double blind placebo control trial study will be conducted in critically ill patients with vitamin d deficiency. investigator aimed to study the effect of oral vitamin d3 supplementation, compare to placebo, on skeletal muscle mass and body composition.

there is a high prevalence of vitamin d deficiency in critically ill patient which is associated with muscle wasting and physical disability. recent study showed that treatment of vitamin d deficiency with high dose vitamin d improved muscle wasting and may prevent further muscle breakdown. investigator want to explore whether a high dose vitamin d3 supplementation, compare to placebo will be able to improve muscle wasting in critically ill patients. the eligible participant will be asked to sign and date the informed consent document then they will be randomized to receive vitamin d3 supplement or placebo, using the computer generated code in conceal envelope. vitamin d3 or placebo will be given orally or feeding tube via feeding tube at a dose of 100,000 iu on day 1 and 3 then 50,000 iu on day 5,7,9,12 followed by 150,000 unit per week for 4 week. serum 25-hydroxyvitamin d, 1,25-dihydroxyvitamin d will be measured at baseline (day 0) then day 10 and day 43 after vitamin d supplementation. moreover, investigator will assess the diameter of rectus femoris by using ultrasonography on day 0,10 and 43.

Eligibility criteria:
inclusion criteria: * age 18 - 70 years old * expected icu stay ≥ 48 hrs exclusion criteria: * participate in other clinical trial * contraindication to receive oral or enteral feeding * do not resuscitate /imminent death * vegetative state, generalize weakness, denervation of leg, both leg amputation * hypercalcemia or hypercalcemia at risk * hyperphosphatemia, * history of nephrolithiasis * end stage renal disease on renal replacement therapy * pregnancy/lactation * consent refusal
clinical evaluation of a bioactive material

Conditions: Tooth Disease

Summary: the clinical performance of a bioactive composite and a posterior resin composite in class ii restorations will be evaluated and compared. after recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. all caries lesions will be removed before restoring. cavities will be divided into two groups: a bioactive composite \[cention n, ivoclar vivadent, schaan, liechtenstein (cn)\] and a posterior resin composite \[g-ænial posterior (gc, tokyo, japan) (gp)\] all restorative procedures will be conducted according to manufacturers' instructions. restorations will be scored using fdi criteria after a week (baseline) 6, 12, 24, 36 and 48 months. descriptive statistics will be performed using chi-square tests.


Eligibility criteria:
inclusion criteria: * age range will be 18 to 65 * patients should have at least 2 approximal caries lesions require restoration * healthy periodontal status * a good likelihood of recall availability exclusion criteria: * poor gingival health * adverse medical history * potential behavioral problems
low-literacy physician-patient intervention promoting colorectal cancer screening

Conditions: Colorectal Cancer

Summary: the purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (crc) screening among the medically underserved.

this study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (cqi) framework, and 2) a brief, multimedia patient education program (pep) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. our provider intervention has demonstrated efficacy to significantly improve crc screening recommendation rates. our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening. we will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote crc screening in these settings. results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings.

Eligibility criteria:
inclusion criteria: * patients aged 50-75 years of age (in month 1 of the study) * patients have had two or more visits to the clinic during the past two years * access community health network patients * university of illinois hospital \& health sciences system patients * patients ages 50 - 75 as of the start of the intervention study * english or spanish-speaking exclusion criteria: * patients \ 75 years of age * patients who have had fewer than two or more visits to the clinic during the past two years * personal history of crc or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with crc or colorectal polyps. * unable to speak english or spanish * compliant with crc screening (fobt or fit within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)

Keywords: early detection of cancer colorectal cancer screening
randomized double blind control trial on effects of ranolazine on new onset atrial fibrillation

Conditions: Atrial Fibrillation New Onset; Hemorrhage; Prolonged QTc Interval; Ventricular Tachycardia; Medical Care; Complications, Late Effect of Complications

Summary: the aim of this study is to evaluate the prophylactic effects of ranolazine on new onset atrial fibrillation in post-operative coronary artery bypass graft and valve surgery patient population at staten island university hospital.

atrial fibrillation (af) is a common complication of cardiac surgery. it has been shown that the onset of af increases in post-operative cardiac surgery population. the rate of af after coronary artery bypass graft (cabg) procedure range from 10-65% and from 37-50% after valve surgery. rates of new onset af are lower for cabg compared to valve procedures. the pathophysiology of post-operative af is not well elucidated. it has been postulated that pre-operative factors such as age, past medical history, operative and post-operative remodeling of the coronary system and hemodynamic pressure changes may contribute to post-operative af. ranolazine is currently approved as an antianginal drug. the antianginal properties of the drug are due to inhibition of the late inward sodium current. through the same mechanism it has been demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias. therefore it is important to prevent or minimize the incidence of new onset post-operative af in post-surgical population.

Eligibility criteria:
inclusion criteria: * male and female candidates (18 years of age and older) undergoing coronary bypass grafting surgery or valve repair or replacement - aortic or tricuspid or pulmonary valves * patients who are not previously on ranolazine * do not have a history of arrhythmia and are not on any antiarrhythmic therapy * patients with qtc on a 12 lead ekg of less than or equal to 460 ms * patients with estimated glomerular filtration rate (gfr) greater than 30 ml/min/1.73 m2 on the initial lab work * available at least 48 hours before surgery exclusion criteria: * patients who are not undergoing above surgeries * patients undergoing surgery for mitral valve replacement/repair * patient with cirrhosis * pregnant patients * patients with chronic atrial fibrillation * patients who had prior adverse drug reactions or allergies to ranolazine * patients who are already taking ranolazine prior to the study * patient who are reported hiv positive (as there are antiretroviral drug interactions) * patients who are on drugs listed in appendix a prior to the study

Keywords: atrial fibrillation new onset ranolazine cabg valve repair/replacement cardiac surgery
the effect of ketogenic-caloric restricted diet on metabolic endotoxemia in prediabetic obese adults

Conditions: Insulin Resistance; Metabolic Endotoxemia; Inflammation Biomarkers; Ketogenic Diet; Caloric Restriction; Obesity; Prediabetes

Summary: insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (lps), disrupts insulin signaling via inflammatory pathways. while dietary interventions may lower lps levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited. this randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum lps levels, in prediabetic obese jordanian adults aged 18-40 years in amman over 12 weeks. ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, lps, inflammatory cytokines. dietary adherence will be monitored through food records. this study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.


Eligibility criteria:
inclusion criteria: * • males and females individuals aged 18-40 years * individuals with a body mass index (bmi) greater than 30 kg/m² and less than 40 kg/m². * individuals medically diagnosed with prediabetes by a physician prior to enrollment in the study as indicated by hemoglobin a1c (hba1c) levels between 5.7% and 6.4% (american diabetes association, 2024), or homa-ir score of greater than 1.8. * individuals demonstrating a willingness to follow the dietary protocol * individuals engaging in sedentary physical activity levels exclusion criteria: * individuals diagnosed with any other chronic disease or type 1 and type 2 diabetes mellitus. * individuals have experienced weight loss of more than 5% in the last three months. * pregnant or lactating women. * individuals undergoing any form of drug treatment. * individuals with a history of major surgery. * individuals have consumed pro-/pre/symbiotic or antibiotics in the past three months. * individuals who engage in any form of regular sports activity.

Keywords: ketogenic diet ketogenic-caloric restricted diet metabolic endotoxemia insulin resistance obesity prediabetes inflammation
evaluation of heart rate variability and endothelial function three months after bariatric surgery

Conditions: Obesity

Summary: was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. the analysis of hrv and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. were also analyzed glp-1, insulin and glucose at fast, and 30 and 60 minutes. the results were compared in parallel with a control group with clinical treatment for obesity.

to assess the pathophysiological mechanisms that leads the benefits in cardiovascular risk after bariatric surgery, through the autonomic nervous system and endothelial function, was performed a longitudinal, study with twenty patients recruited for the bariatric surgery group and 20 for clinical treatment. the analysis of hrv and endothelial function were performed through peripheral arterial tonometry, in patients with obesity before and after three months of bariatric surgery. were also analyzed glp-1, insulin and glucose at fast, and 30 and 60 minutes. the results were compared in parallel with a control group with clinical treatment for obesity.

Eligibility criteria:
inclusion criteria: patients with obesity grade 3 \[body mass index (bmi) ≥ 40kg/m2\] or grade 2 (bmi 35-39.9kg/m2) with comorbidities exclusion criteria: current use of incretin mimetics or inhibitors of dipeptidyl peptidase-4 (dpp4); and history of a previous cardiovascular event (acute myocardial infarction, stroke or peripheral obstructive arterial disease)