Kornimate/medical-research-clean huggingface dataset:
hyperuricemia and diabetic nephropathy

Conditions: Hyperuricemia; Diabetic Nephropathies

Summary: the purpose of the study is to detect the effect of treatment of hyperuricemia on egfr (estimated glomerular filtration rate) as an objective criterion for assessment of progression of diabetic nephropathy in patients with type 2 diabetes mellitus.

after being informed about the study and potential risks, all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry. at week 0, patients who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to febuxostat (80 mg, once daily) or placebo (once daily) in patients with type 2 diabetes mellitus and stage 3 chronic kidney disease (estimated glomerular filtration rate 31:59).

Eligibility criteria:
inclusion criteria: * patient population will include both males and females above the age of 18 years with t2dm and diabetic nephropathy stage 3 ckd (egfr: 31-59). exclusion criteria: * patients with history of hypothyroidism, alcoholism, urinary tract infections, glomerulonephritis, myeloproliferative disorders and gout "as gout is a common inflammatory arthropathy characterized by painful and swollen joints resulting from precipitating uric acid crystals but hyperuricemia is commonly asymptomatic" or on drugs capable of inducing hyperuricemia will be excluded from the study. * any patient will develop acute kidney injury episode at any time of the study will be excluded from the study. * patients with uncontrolled hypertension will be excluded from the study.
assessment of the pharmacokinetics of a sustained release formulation of a tramadol/acetaminophen combination

Conditions: Pain

Summary: 1. objective: to evaluate the pharmacokinetic profiles of an sr 75 mg tramadol/650 mg acetaminophen formulation compared with an immediate release (ir) 37.5 mg tramadol/325 mg acetaminophen formulation after a single dose and at steady state 2. subjects: healthy subject 3. methods: a phase i study to evaluate the pharmacokinetic sustained release and immediate release treatment profiles at steady state.

this study was open, randomized, 2-period, 2-treatment multiple-dose crossover study of immediate release treatment and sustained release treatment was designed to assess the pharmacokinetics after a 2-day repeated administration in which the steady state was achieved.

Eligibility criteria:
inclusion criteria: * subjects between the ages of 20 and 45 years * subjects weighed ≥ 45 kg and were within 20% of their ideal body weight * no clinically relevant abnormalities identified by vital sign measurement, 12-lead electrocardiography and routine laboratory test exclusion criteria: * hypersensitivity or histories of sensitivity to either tramadol or acetaminophen * evidence or histories of clinically significant renal, digestive, respiratory, musculoskeletal, endocrine, psychiatric, neurological, hematological or cardiovascular diseases * taking any prescription or herbal medicines within 2 weeks before the study or any over-the-counter medication within 1 week before the study * systolic blood pressure (sbp) ≥ 160 mmhg or ≤ 100 mmhg or diastolic blood pressure (dbp) ≥ 95 mmhg or ≤ 60 mmhg * any surgical or medical conditions that could affect drug absorption

Keywords: tramadol acetaminophen pharmacokinetics sustained release immediate release
efficacy and safety of rectally administered bbt-401-1s in subjects with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is an open label, single-arm, proof of mechanism study to explore the efficacy and safety of rectally administered bbt-401-1s in subjects with ulcerative colitis.


Eligibility criteria:
inclusion criteria: * male or female, of any race, ≥18 and ≤60 years of age on day 1. * have been diagnosed with active distal uc for ≥3 months prior to day 1, as determined by clinical and endoscopic evidence and documented in a histopathology evaluation. * have uc that is restricted to between the descending colon and the rectum (ie, left sided distal colitis), with demarcation of the lesion confirmed by endoscopy. * have a total mayo score ≥6, an endoscopic subscore ≥2, rectal bleeding subscore ≥1, and a stool frequency subscore ≥1. exclusion criteria: * have used any biologics or janus kinase (jak) inhibitors including, but not limited to, anti tnf α biologics or tofacitinib for the treatment of uc. * have used any purine analogues (azathioprine, mercaptopurine, or thiopurines) or immunosuppressants (methotrexate or cyclosporine) for the treatment of uc within 12 weeks or have any history of nonresponse to these medications. * have used any rectal therapy for the treatment of uc with exception of rectal suppository of 5-aminosalicylic acid, or any intravenous corticosteroids within 2 weeks prior to day 1. * have received oral and/or rectal suppository 5-aminosalicylic acid, oral sulphasalazine, or low-dose oral corticosteroids that have been stable for \<4 weeks. doses of the drugs must remain stable until the last dose of study drug. * have received any other concomitant medications for uc that have been stable (ie, have not started dosing with a new drug or had a change to their dosing regimen) for \<7 days or 5 half lives, whichever is longer, prior to day 1. * have crohn's disease, indeterminate colitis, ischaemic colitis, fulminant colitis, toxic megacolon, chronic pancolitis, or symptomatic intestinal stenosis. * have a history of extensive colonic resection (subtotal or total colectomy) or are anticipated to require surgical intervention for uc. * have an ileostomy or colostomy. * have evidence of treatment for clostridium difficile infection or other pathogenic bowel infection within 60 days or for another intestinal pathogen within 30 days prior to day 1.
omecamtiv mecarbil post-trial access study

Conditions: Chronic Heart Failure With Reduced Ejection Fraction

Summary: the primary objective of this study is to provide access to omecamtiv mecarbil for participants who have completed galactic-hf 20110203.

this study was conducted by amgen as the ind holder, with cytokinetics as a collaborator. due to the termination of the collaboration agreement between amgen and cytokinetics in may 2021 and subsequent transfer of the omecamtiv mecarbil ind from amgen to cytokinetics, cytokinetics is now listed as the sponsor.

Eligibility criteria:
inclusion criteria: * participant has provided galactic-hf pta informed consent prior to initiation of any study specific activities/procedures. * participant has completed galactic-hf. exclusion criteria: * investigational product was permanently discontinued during galactic-hf due to protocol-specified reason. * female participant is pregnant or breastfeeding or planning to become pregnant or breastfeed during treatment and for an additional 5 days after the last dose of treatment. * female participants of childbearing potential unwilling to use 2 acceptable methods of effective contraception during treatment with om and for an additional 5 days after the last dose of treatment. * female participants of childbearing potential with a positive pregnancy test assessed on day 1 by a urine pregnancy test. * participant has known sensitivity to any of the products or components to be administered during dosing. * history or evidence of any clinically significant disorder, condition or disease that, in the opinion of the investigator or amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.
the improvement in uroflow and postvoid residual urine after urethral meatotomy in children with meatal stenosis

Conditions: Urethral Meatal Stenosis

Summary: the improvement in uroflow and postvoid residual urine in children after urethral meatotomy for meatal stenosis. the hypothesis is that there is an improvement in both parameters, thus justifying the procedure.

urethral meatal stenosis is a known complication of circumcision occuring in up to 3% of newborns undergoing circumcision. it is customary to perform a meatotomy in order to prevent bladder outlet obstruction, although bladder outlet obstruction has never been proven and improvement has only been proved in a single, small, retrospective study. our intention is to evaluate the improvement in objective parameters (uroflow and postvoid residual urine) after urethral meatotomy by measuring these parameter before the procedure, one month after the procedure and one year after the procedure. symptoms assessment will also be performed.

Eligibility criteria:
inclusion criteria: * toilet trained children * before puberty * no other urologic disease that might affect the measurements * primary (first) repair exclusion criteria: * children unable to urinate on command * children that have started their sexual puberty * children with other urologic disease that might affect the study measurements * recurrent stenosis after previous repair

Keywords: meatal stenosis meatotomy uroflow postvoid residual
nitrous oxide for major depressive disorder

Conditions: Depressive Disorder; Major Depressive Disorder; Treatment Resistant Depression; Depressive Disorder, Major; Depression

Summary: this study aims at investigating the persistence of antidepressant effect of nitrous oxide (n2o) for treatment-resistant depression(trd). the investigators also aim to assess the effect of n2o on the electroencephalograph, multimodal magnetic resonance imaging(mri), blood cytokines, feces bacteria flora and neuropsychological performance in patients with trd. the investigators further aim to identify the predictors of n2o's antidepressant effeect using the above techniques.


Eligibility criteria:
inclusion criteria: * adult (≥18 years, both sexes), with icd-10 criteria for mdd without psychosis, as determined by a structured clinical interview mini international neuropsychiatric interview * moderate to severe depression, as defined by a pretreatment score \>17 on the hdrs-17 scale * trd was defined as having had at least two adequate dose-duration, antidepressant medication failures in the current episode and a lifetime failure of at least three antidepressant medication trials. * informed consent to participate in this study exclusion criteria: * a history of bipolar disorder, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, panic disorder, or documented axis ii diagnoses; active suicidal intention, as determined by clinical interview * active or recent (\<12 months) substance abuse or dependence; excluding nicotine * presence of acute medical illness that could interfere with study participation, including significant pulmonary disease * acute severe suicidal ideation * acute psychosis * received ect treatment within 6 months * history of nmda-antagonists (e.g., ketamine) intake * pregnancy or breastfeeding * any contraindications to the use of nitrous oxide (e.g., pneumothorax, middle ear occlusion, elevated intracranial pressure, chronic cobalamin or folate deficiency unless treated with folic acid or vitamin b12).

Keywords: nitrous oxide laughing gas
effect of a high protein diet on the 24-hour profile of ghrelin, gh (growth hormone) and igf-1 (insulin-like growth factor-1)

Conditions: Diabetes Mellitus, Type 2

Summary: in this study we tested the hypothesis that an increase in protein content of the diet will result in an increase in the 24-hour integrated circulating growth hormone (gh) and insulin-like growth factor-1 (igf-1) concentrations and an increase in lean body mass in people with untreated type 2 diabetes.

subjects with untreated type 2 diabetes were studied using a randomized crossover design. the study began with an initial two-week observation period. subjects then were randomly assigned to one arm of the study for 5 weeks. the carbohydrate:protein:fat ratio for the control diet is 55:15:30 whereas for the test diet it is 40:30:30. following a five-week washout period, subjects were assigned to the other arm of the study. all meals were provided by the sdtu. a six-day rotating meal plan has been devised. at the beginning and end of the 5-week diet period, the subject was admitted to the sdtu (special diagnostic and treatment unit), was provided with the meals appropriate for the test or control arm of the study, and had blood drawn at various times during a 24-hour period. in addition to measurement of gh and igf-1, igf-binding proteins 1 and 3, ghrelin, and body composition were determined.

Eligibility criteria:
inclusion criteria: * people ages 55 - 75 years old with type 2 diabetes, not receiving oral hypoglycemic agents or insulin. * fasting plasma glucose \< 250 mg/dl (\<14 mm) (tghb \< 14%). exclusion criteria: * subjects will be screened for hematological abnormalities, liver disease, kidney disease, macroalbuminuria (\>300 mg/24 hours), untreated thyroid disease, congestive heart failure, angina, life-threatening malignancies, proliferative retinopathy, diabetic neuropathy, peripheral vascular disease, serious psychological disorders, a body mass index \> 35, and a fasting triglyceride of \> 400 mg/dl. * presence of any of the above will be considered exclusion criteria.

Keywords: cholesterol creatinine clearance diabetes glycohemoglobin high protein diet
imaging measures of respiratory health registry

Conditions: Respiratory Disease; Healthy

Summary: this is a prospective, observational cohort registry that aims to collect data on pulmonary structure and function in healthy people and those with respiratory disease, using structural and functional pulmonary 1h-mri and hyperpolarized 129xe-mri. outcome measures generated from mri may include but are not limited to measures of regional ventilation, pulmonary microarchitecture, and regional gas exchange. additionally, one of the goals of the registry is to facilitate the development of novel image analysis techniques that have not yet been invented. these data will be stored along with demographic data, clinical data, and pulmonary function testing (pft) data. this is an open registry. eligible local and international investigators/institutions can apply for access.


Eligibility criteria:
respiratory disease inclusion criteria: 1. physician-diagnosed lung disease - based on a diagnosis made by a treating staff physician and confirmed by the principal investigator. 2. age 0-99 years. 3. informed consent by participant, parent, or legal guardian 4. in the opinion of the investigator, the participant will likely be able to perform maneuvers to obtain technically acceptable pulmonary xemri images. exclusion criteria: 1. physical findings at screening that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the research data. 2. requirement of supplementary oxygen to maintain an oxygen saturation above 95%. 3. failed mri screening form. 4. history of claustrophobia. 5. known current pregnancy or lactation. healthy inclusion criteria: 1. age 0-99 years 2. informed consent by participant, parent, or legal guardian 3. in the opinion of the investigator, the participant will likely be able to perform maneuvers to obtain technically acceptable pulmonary mri images. exclusion criteria 1. physician-diagnosed lung disease. 2. failed mri screening form. 3. history of claustrophobia. 4. physical findings at screening that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the research data. 5. known current pregnancy or lactation.
self-expandable metal stents versus multiple plastic stents for palliation of biliary obstruction

Conditions: Bile Duct Obstruction, Extrahepatic; Cancer of the Pancreas; Cancer of the Bile Duct; Biliary Stricture

Summary: a randomised clinical trial to compare the clinical efficacy of multiple plastic stents to fully covered self expanding metal stents in the palliation of distal malignant biliary obstruction in patients with irresectable tumours.


Eligibility criteria:
inclusion criteria: * 18years of age or older * informed consent obtained after oral and written information * clinical data in accordance with a malignant bile duct obstruction * imaging evidence: (ultrasonography (us), computed tomography (ct) or magnetic resonance imaging (mri) shows signs of extrahepatic malignant common bile duct obstruction * typical ercp findings of a malignant common bile duct stenosis * proximal margin of the bile duct stenosis ≥2 cm from the hepatic confluence * bilirubin \> 50 micromol/l * radical surgery not deemed possible exclusion criteria: * patients with active hepatitis or other jaundice-causing hepatic diseases * informed consent not obtained or patient unable to give informed consent * patients with no understanding of english, afrikaans or xhosa where it is not possible to obtain informed consent * metastasis with multiple significant intrahepatic stenosis causing blockage of one or more segments of the liver (liver metastasis otherwise not an exclusion criteria) * the patient is a possible candidate for surgical resection * suspicion of a non-malignant bile duct obstruction, e.g. stones or benign stenosis (should initiate further investigations) * the proximal end of the stenosis is \< 2 cm from the hepatic confluence * previous bii or roux-en-y gastric reconstruction * significant duodenal obstruction making ercp difficult * previous bile duct stent
hand function in patients with poly- or dermatomyositis

Conditions: Polymyositis; Dermatomyositis

Summary: the aim of this study is to investigate the hand function in patients with poly-and dermatomyositis and compare this to healthy individuals and norm values and secondly if hand function correlates to activity performance and health related quality of life. the study is a cross-sectional study. to assess hand function the investigators will measure grip force with grippit and arm/hand mobility using epm-rom scale. the activity performance will be measured with myositis activities profile and health related quality of life will be assessed with sf-36. the investigators' hypothesis is that hand function is reduced in comparison to the healthy population and that hand function affects both activity performance and health related quality of life.


Eligibility criteria:
inclusion criteria: * patients with definite or probable polymyositis or dermatomyositis (according to criteria by bohan and peter) were included in the study exclusion criteria: * other diseases or injuries that could affect arm/hand mobility and grip force for example other rheumatological or neurological disease.

Keywords: polymyositis dermatomyositis grip force quality of life activity performance
medical nutrition therapy and diabetes self-management education for people with disabilities

Conditions: Type 2 Diabetes; Physical Disability

Summary: the purpose of this project is to develop, and pilot test an accessible and inclusive medical nutrition therapy and diabetes self-management education program for people with type 2 diabetes and physical disabilities.

this study will use a three-arm randomized control trial design. eligible and consented participants will be assigned to one of three groups: (1) intervention with high-tech support, (2) intervention with low-tech support, and (3) attention-control group. the active intervention period will include six months of weekly health coaching calls and technology access. the low-tech support group will receive six months of weekly coaching calls and weekly email containing related materials in pdf format but no video and technology content.

Eligibility criteria:
inclusion criteria: 1. diagnosis of t2dm 2. 18 to 65 years of age 3. living with a permanent physical disability such as sci, spina bifida, multiple sclerosis, stroke 4. ability to converse in and read english 5. availability of a smartphone or computer that can run apps 6. have internet connection capabilities exclusion criteria: 1. current enrollment in any diabetes related intervention 2. present or soon-planned pregnancy 3. major heart attack or heart surgery in the past 12 months 4. have undergone a dialysis, kidney transplant or a kidney surgery in the past 12 months 5. severe cognitive impairment 6. severe untreated depression in the past 6 months
a phase ii trial of intermediate radiation dose for lymphoma

Conditions: Follicular Lymphoma

Summary: the purpose of this study is to determine the optimal radiation dose fractionation regimen for low grade follicular lymphoma. it is hypothesized that the complete response rate with the use of 12 gy in 6 daily fractions is 80% (10% total width of the confidence interval) at 3 months. this phase ii study will evaluate whether an intermediate dose for follicular lymphoma is associated with excellent response rates while minimizing acute and late toxicity.


Eligibility criteria:
inclusion criteria: * ≥ 18 years or older * pathology review at sunnybrook health sciences centre showing low grade (grade 1- 2) follicular lymphoma * previously un-irradiated stages i-iv low grade follicular lymphoma * radiation indicated for local disease control (radical or palliative) * able to give informed consent * non-bulky targets (less than 7cm) exclusion criteria: * systemic therapy (including steroids) for lymphoma within 3 months before or after radiotherapy * prognosis less than 3 months * pregnancy

Keywords: radiation
effects the glycemic index on metabolic risk markers

Conditions: Metabolic Syndrome X

Summary: recent population studies have shown that the glycemic index (gi) of food products is positively associated with the risk of developing type 2 diabetes and cardiovascular disease (cvd). in the pathogenesis of type 2 diabetes and cvd, inflammatory processes play a pivotal role. in a previous intervention study (11 weeks), however, we found no effects of lower-gi vs. higher-gi diets on fasting inflammatory markers in subjects with increased risk of developing the metabolic syndrome. people, however, spent most of their time in the postprandial period. therefore, there is a need to study the postprandial effects of low-gi vs. high-gi diets. in addition, it needs to be emphasized the gi is derived from studies in lean subjects, while especially overweight and obese people suffer from metabolic aberrations related to the development of type 2 diabetes and cvd. aim: to investigate in obese subjects the postprandial effects of a low-gi vs. high-gi food product on metabolic risk markers. a second research objective is to compare these effects with those in lean subjects.


Eligibility criteria:
inclusion criteria: * healthy and obese men exclusion criteria: * smoking
the effect of biscuit containing kothala himbutu on blood glucose in patients with diabetes. a randomized control study

Conditions: Type 2 Diabetes Mellitus

Summary: the investigators intend to conduct a triple blind randomized clinical trial to investigate the effect of a biscuit containing herbal extract, available in the market on the fasting blood sugar control in patients with diabetes mellitus and also to find out whether there are any side effects on other vital organs such as kidneys and liver.

the effect of a biscuit containing the extract of salacia reticulata (kothala himbutu) on the reduction of blood glucose levels in patients with type 2 diabetes mellitus. a single center randomized triple blind placebo controlled two period two sequence crossover clinical trial.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes for minimum period of 6 months 2. aged between 30 and 65 years 3. stable glycaemic control over the preceding 2-3 months. they will be initially selected from a range of hba1c varying from 6.5 - 14 and the individual subject should not have a variation of \>20% between the previous hba1c and the hba1c done at the commencement of the study exclusion criteria: 1. chronic kidney disease with estimated glomerular filtration rate less than 30ml/hour 2. severe valvular heart disease or heart failure. 3. those on insulin therapy 4. severe liver disease (ast \> 10 x times the upper limit)

Keywords: biscuit containing salacia reticulate randomised controlled trial