Kornimate/medical-research-clean huggingface dataset:
efficacy of autologous bone marrow derived stem cell transplantation in patients with type 2 diabetes mellitus-2

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to improve blood glucose control in type 2 diabetes mellitus patients.

we hypothesize that autologous bone marrow derived stem cell transplantation(abmsct)into the pancreas of patients with t2dm, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(\>0.4 u/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. it is assumed that abmsct in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and vascular endothelial growth factor(vegf) and creates a microenvironment which supports beta cell/resident stem cell activation and survival.

Eligibility criteria:
inclusion criteria: 1. patients with type 2 diabetes mellitus between 30 and 70 years of age. 2. failure to triple oha and on stable doses of insulin for atleast 3 months. 3. on vildagliptin,pioglitazone and metformin for atleast 3 months along with insulin to maintain euglycemia. 4. hba1c \< 8.5%. 5. insulin requirement ≥0.4 iu/kg/d. 6. gad antibody negative status. exclusion criteria: 1. patients with t1dm or secondary diabetes. 2. patients with serum creatinine \> 1.5 mg/dl. 3. abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory). 4. history of cholecystitis/ cholelitiasis/ cholecystectomy 5. seropositivity for hiv, hbsag and hcv. 6. history of myocardial infarction or unstable angina in the previous 3 months. 7. history of malignancy 8. patients with active infections.
compensatory cognitive training for schizophrenia

Conditions: Schizophrenia

Summary: this study aimed to investigate the effects of compensatory cognitive training plus treatment as usual (cct+tau) versus treatment as usual (tau) on on self-esteem, self-efficacy, quality of life, and self-stigma for schizophrenia.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia, based on the icd-10 diagnostic criteria for research (world health organization, 1992) * age from 20 to 65 * attending day care center regularly for at least 3 months * taking stable dose of medication for at least 3 months exclusion criteria: * comorbid autism spectrum disorder * comorbid mental retardation * lacking the reading and writing skills

Keywords: schizophrenia compensatory cognitive training generalized estimating equation psychosocial correlates self-stigma
study of the treatment and outcomes in critically ill patients with covid-19

Conditions: Coronavirus Infection

Summary: multicenter observational/registry study of the clinical features and outcomes of critically ill patients with covid-19.

the goals of this project are to determine the independent risk factors for hospital mortality and acute organ injury, and to identify treatment strategies associated with improved survival. additionally, we will assess outcomes according to differences in geographic and institutional parameters.

Eligibility criteria:
inclusion criteria (each of the following): 1. adults (aged ≥18 years) 2. laboratory-confirmed diagnosis of covid-19 3. hospitalized in the icu for illness related to covid-19 exclusion criteria: -none
hip: hiv intervention for providers

Conditions: HIV Infections

Summary: the purpose is to encourage provider participants to evaluate high risk hiv transmission behaviors and offer prevention messages to their hiv+ patients which will, in turn, reduce rates of unprotected anal and/or vaginal sex with partners of known hiv sero-negativity or unknown hiv serostatus. it is hypothesized that patients of providers participating in the hip intervention will report higher reduction in sexual risk practices, when compared to the patients of the providers who were randomized into the control condition.


Eligibility criteria:
inclusion criteria: * provider participants: (1) licensed md, np or pa on staff at the participating institution; (2) has a minimum panel of 5 hiv+ patients; (3) sees patients at least one-half day per week in the clinical setting; (4) is willing to participate in all intervention training sessions; and (5) is willing and able to provide full informed consent. hiv+ patient participants:(1) report at least 1 encounter of unprotected anal or vaginal sex with known hiv- or unknown serostatus partner in the preceding six months; (2) patient's primary provider is enrolled as a participant in the study; (3) age 18 years or older; and (4) willing and able to provide informed consent. exclusion criteria: -

Keywords: hiv
effect of olive leaves as hypoglycemic agents in diabetic subjects

Conditions: Diabetes

Summary: background: animal studies indicate that olive leaf extract normalizes blood glucose. we hypothesized that olive leaf extract might be of benefit in human subjects. methods: a total of 79 adults with diabetes were randomly assigned to treatment with olive leaf extract capsules or matched placebo. measures of glucose homeostasis including glucose, insulin and hba1c were measured and compared by treatment group.

the present study is a randomized, double blind, placebo controlled, clinical trial with a 14 week duration. patients were randomized to treatment with a tablet of olive leaves or matching placebo in 1:1 ratio. patients were instructed to consume a diet consistent with ada recommendations and an exercise training program was prescribed. weight, height, systolic blood pressure (sbp) and diastolic blood pressure (dbp) were measured in all subjects at the beginning and at the end of the study. venous blood samples were drawn after an overnight fast of not less than 12 hours. laboratory tests included fasting blood glucose (fbg), hba1c, insulin, lipid panel and liver and renal function. a total of 79 subjects (51 men, 28 women) aged 18-79 years with type 2 diabetes mellitus, were recruited from and followed up at an outpatient clinic. the subjects were selected from a series of 93 consecutive diabetic patients. eligible patients had been diagnosed with t2dm for at least 1 year. subjects were randomized to treatment with olive leaf extract pills (1 500 mg pill daily taken orally) or matching placebo. the intervention was prepared as follows: olive leaves were picked from the barnea cultivar in the jezreel valley region of israel and immediately freeze-dried on dry ice. after the leaves were thoroughly rinsed with sterile distilled water to remove dust, insecticides, and contaminating material, the leaves were ground and successively soxhlet extracted with hexane for 3 h and 80% aqueous ethanol for 6 h. the alcoholic extract was concentrated under reduced pressure at 25 °c, and reconstituted with 30% ethanol in water. olive leaves or placebo tablet was taken once daily orally throughout the study. all subjects continue their stable treatment to diabetes. data were analyzed using spss v10.0 (spss inc., chicago, usa). continuous data were described a mean ± standard deviation and compared by treatment assignment using the t-test for independent samples. associations between continuous variables were described by calculating the pearson's correlation coefficients. nominal variables such as sex and treatment assignment are described using frequency counts and compared by treatment assignment using the chi square test (exact as appropriate). all tests are two-sided and considered significant at p\<0.05.

Eligibility criteria:
inclusion criteria: * adults * type 2 diabetes exclusion criteria: * type 1 diabetes

Keywords: diabetes blood glucose olive leaf extract
comparative study between autologous adipose tissue graft versus microfracture for treatment of articular cartilage defects

Conditions: Knee Osteoarthritis

Summary: knee arthroscopy using standard portals will be performed in three groups. complete evaluation of all intra -articular structures will be performed followed by accurate localization of the cartilage defect and measurement of its dimensions. the cartilage lesion grading according to the international cartilage repair society system (icrs). the patients assigned for the first group will have liposuction through a minor 1 cm incision on the abdomen to obtain adequate amount of emulsified adipose tissues (50 - 60 cc). autologous adipose tissue will be mixed with autologous hyaline cartilage obtained from non-weight bearing areas of the knee in prepared mold. the graft will be mixed with fibrin glue and left to solidify a little. after obtaining the fashioned graft from the mold it will be fixed in to the defect site by fibrin glue through mini open approach and stability of the implant fitted in the site will evaluated by gentle cycling of the joint. during the graft preparation, a high tibial osteotomy will be performed. patients assigned for the second group will have microfracture in association with open wedge high tibial osteotomy. patients assigned for the third group will have open wedge high tibial osteotomy. standard titanium t locked plate will be used to fix the open wedge osteotomy in the three groups.


Eligibility criteria:
inclusion criteria: * age group 18 to 60 years old. * cartilage defect size range 2-5 cm2. * outer bridge classification ii \& iii. * single full thickness symptomatic femoral condyles ulcer. * varus deformity of the affected knee 50 - 100. exclusion criteria: * advanced knee osteoarthritis. * knee range of motion less than 1000. * ligamentous injury of the affected knee. * recent intra articular injection of any type with in last 6 months. * fracture around the knee. * inflammatory joints disorders. * tumors. * immunocompromised patients. * body mass index \< 35 * valgus deformed knee any degree * sever varus deformed knee \< 10 0
a study to evaluate the safety and efficacy of humia inj. in patients with symptomatic osteoarthritis of the knee

Conditions: Osteoarthritis of Knee

Summary: a multi-centre, parallel, double-blind, active comparator, randomised phase iii clinical trial


Eligibility criteria:
inclusion criteria: * primary knee osteoarthritis confirmed clinically and radiologically according to american college of rheumatology criteria have joint pain * kellgren-lawrence grade ⅰ to ⅲ confirmed radiologically within 6 months * knee pain under weight-bearing pain(100mm-vas) greater than 40mm * able to walk without assistive devices * patients willing and able to provide signed informed consent after the nature of the study has been explained exclusion criteria: * body mass index (bmi) \> 32 * history of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity * systemic intravenous steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months * has clinically severe tense effusion of the target knee diagnosed positive according to patella tap test * undergo knee replacement surgery of the target knee
a trial to evaluate the effect of rosuvastatin on inflammation in patients undergoing isolated cardiac valve surgery

Conditions: Valvular Cardiac Surgery

Summary: high-dose statin therapy around the time of surgery, decreases inflammation in patients undergoing cardiac valve surgery, and thereby improves clinical outcomes.


Eligibility criteria:
inclusion criteria: * single or multiple valve repairs or replacements without coronary artery bypass grafting * bentall procedure, but no other aortic procedures * with or without accompanying maze procedure (surgical treatment for atrial fibrillation) exclusion criteria: * age under 18 years old * urgent or emergency surgery * unable to provide consent * presently on statin therapy or exposure to statins within a month of surgery * chronic anti-inflammatory use, including steroids and nsaid's (nonsteroidal anti-inflammatory drugs) (not to be used during the treatment period) * known hypersensitivity to rosuvastatin * active liver disease indicated by ast/alt higher than 3 times the upper limit of normal * pregnant or nursing women * on drugs with interactions (cyclosporine, gemfibrozil, lopinavir/ritonavir or atazanavir/ritonavir, niacin) severe renal impairment not on dialysis * creatinine clearance \< 30 ml/min/1.73 m2 * known myopathy and inflammatory diasthesis (such as systemic lupus erythromatosus, rheumatoid arthritis, and inflammatory bowel disease) * human immunodeficiency virus
meta trial - a mixed methods process evaluation

Conditions: HIV; Pre-diabetes

Summary: the aim of this study is to conduct a mixed methods process evaluation of the meta trial. semi-structured interviews, focus groups, and brief questionnaires will be conducted with a purposive sample of participants (patients and healthcare providers) who were involved in the trial to explore the feasibility, acceptability and perceived effectiveness of the trial intervention.

the meta trial was a phase ii randomised double-blind placebo-controlled trial that is being conducted in dar es salaam, tanzania to evaluate the use of metformin in hiv-positive persons on antiretroviral therapy (art) with pre-diabetes. this study aims to explore the feasibility, acceptability and perceived effectiveness of the meta trial intervention by conducting qualitative interviews, focus groups, and brief questionnaires with a purposive sample of participants (patients and healthcare providers) in tanzania who are involved in the meta trial. data collection will commence during june-july 2025 with a purposive sample of patients and health care professionals who were involved in the trial (n=50-60).

Eligibility criteria:
inclusion criteria: * participants who participated in the meta trial * participants who have the capacity to provide written informed consent

Keywords: qualitative research process evaluation metformin africa hiv pre-diabetes
investigating the influence of semaglutide on the pharmacokinetics of single doses of atorvastatin and digoxin in healthy subjects

Conditions: Diabetes; Healthy

Summary: the trial is conducted in europe. the aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.


Eligibility criteria:
inclusion criteria: * male and female, age between 18 and 55 years (both inclusive) at the time of signing informed consent * body mass index between 20.0 and 29.9 kg/m\^2 (both inclusive) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. women of child-bearing potential must use an effective method of birth control throughout the trial including the 5 weeks follow-up period. only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner * any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases * use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal supplements, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to visit 2 (first dose administration) * history of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test * history of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 ml of beer or lager, one glass (120 ml) of wine, or 20 ml spirits) * smoking in the last 3 months prior to screening or a positive nicotine test
efficacy study of femoral nerve block in children with a femur fracture

Conditions: Femoral Fractures; Pain, Postoperative

Summary: the purpose of this study is to examine the efficacy of the use of marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.

children with femur fractures can have severe pain after elastic nail fixation. the current national standard for post operative pain control would be intravenous narcotics. in addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. these methods are hematoma block or a femoral nerve block. both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.

Eligibility criteria:
inclusion criteria: * a child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails * weight of 30-100 kg * child must be older than 6 years old exclusion criteria: * any child that had an open fracture * a child that has a pain abnormality * any child with an allergy to local anesthetic * any child with a neurological injury * any child with the inability to report pain * any child that is unable to use a pca post-operatively

Keywords: femoral fractures pediatrics pain, postoperative
laparoscopic nissen fundoplication comparing division versus non-division of short gastric vessels

Conditions: Gastroesophageal Reflux

Summary: recently, total fundoplication followed by laparoscopic esophageal hiatoplasty has been the most common surgical treatment for gastro-esophageal reflux. although this procedure is effective, some patients still develop complications. indeed, dividing the short gastric vessels is claimed by many authors to confer benefit to patients even it could not be proved in other studies. in an attempt to evaluate the role of dividing the short gastric vessels and its long-term impact on the surgical treatment of the gastro-esophageal reflux, the investigators initiated a randomized clinical trial to clarify this important fact. patients were recruited for this trial and short-term results had been already published in a national journal. the investigators are now registering this study which particularly focuses on the endoscopic outcome evaluated on long-term basis after gastro-esophageal reflux surgical treatment.


Eligibility criteria:
inclusion criteria: * objective gastroesophageal reflux in adults exclusion criteria: * esophageal motility disorder * hard stenosis * previous antireflux surgery

Keywords: fundoplication gastroesophageal reflux gastric vessels surgery
managing acute schizophrenia, a comparison between two atypical antipsychotics

Conditions: Schizophrenia

Summary: the purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.


Eligibility criteria:
inclusion criteria: * male or female subjects, aged 18 - 60 * subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to dsm-iv * subjects' illness must not, in the opinion of the investigator, be caused by substance abuse * bprs total score (1 to 7 scale) of greater than or equal to 36 at visit 1 * subjects must have a minimum total score of greater than or equal to 14 on the five items of the panss-ec and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications exclusion criteria: * treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration * treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration * electroconvulsive therapy (ect) within 1 month (90 days) prior to study entry (visit 1) * treatment with remoxipride within 6 months (180 days) prior to visit 1 * documented history of allergic reaction to study medications
a phase i/iii study of d961h 10 mg and 20 mg in japanese paediatric patients with gastrointestinal acid related diseases

Conditions: Gastric Ulcer (GU); Duodenal Ulcer (DU); Anastomotic Ulcer (AU); Non-erosive Reflux Esophagitis Disease (NERD); Reflux Esophagitis (RE); Zollinger-Ellison Syndrome

Summary: the objective of this study is to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once daily oral administration of d961h 10 mg and d961h 20 mg in japanese paediatric patients aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (gu), duodenal ulcer (du), anastomotic ulcer (au), non-erosive reflux esophagitis disease (nerd), reflux esophagitis (re) or zollinger-ellison syndrome.


Eligibility criteria:
inclusion criteria: * provision of signed written informed consent from the patient's guardian * patients aged ≥ 1 year to 14 years old * patients who have a diagnosis of or suspected to have gu, du, au, nerd, re or zollinger-ellison syndrome. exclusion criteria: * patients less than 10 kg in weight. * use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the randomisation/registration. * significant clinical illness within 4 weeks prior to the registration * presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators. * positive for pregnancy test by urinary or lactation for post-menarchal females. * previous total gastrectomy

Keywords: gastric ulcer (gu) duodenal ulcer (du) anastomotic ulcer (au) non-erosive reflux esophagitis disease (nerd) reflux esophagitis (re) zollinger-ellison syndrome
the prevalence and risk factors for thyroid dysfunction in pregnant women in taiwan

Conditions: Thyroid Disease Pregnancy

Summary: the investigators' aim is to enroll around 2000 patients from taipei, keelung, linkou, chiayi and kaohsiung cgmh. all participants will receive universal thyroid function screening at 1st trimester, and those who was found to have hyperthyroidism or hypothyroidism will be referred to endocrine department for further treatment. all participants will be followed at outpatient clinic, and their obstetric visit finding will be recorded. the maternal and neonatal outcomes will be analyzed.


Eligibility criteria:
inclusion criteria: * pregnant women at first trimester (\< 14 weeks of gestational age) exclusion criteria: * none