Kornimate/medical-research-clean huggingface dataset:
oat-gut-brain: effects of oats and rice on comprehensive health of metabolically challenged individuals

Conditions: High Cholesterol/Hyperlipidemia; High Blood Pressure; Overweight and Obesity

Summary: the overall objective of this research entity is to reveal the holistic health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. this is achieved by investigation of the plasma lipids, plasma antioxidant status, fecal microbiota and fecal bile acids. additionally the effect of the 6-week diet on posptprandial glycemia and postprandial satiety and vitality are investigated.

aims in this 6-week randomised, single-blinded clinical trial, including a postprandial study at the 6 week time point, with metabolically challenged volunteers on oat-rich low-gluten diet, are to: 1. compare effect of oat and rice rich diets to blood lipid and glucose status, perceived gut well-being and diet quality. 2. investigate changes in microbiota, scfas, plasma antioxidant status and inflammation markers resulting from consumption of oat or rice rich low gluten diets. 3. examine the impact of the oat and rice rich gluten free diet on the change in metabolite profiles in blood. 4. find out the long-term effects of oat and rice consumption on recovery and vitality by modulating the gut-brain axis and measured with neuropsychological testing and using tryptophan metabolites as markers. 5. discover how the long-term consumption of oats and rice and their possible alterations in gut microbiota affect subsequent postprandial glycaemia and response of microbiota to the meal (as seen in plasma scfas).

Eligibility criteria:
inclusion criteria: * commits to follow low-gluten diet for 6 weeks * 30 - 68 years of age * bmi \> 25 kg/m\^2 * high cholesterol and/or hypertension exclusion criteria: * regular medication that can affect the gut * pregnancy or lactation * recent course of antibiotics (less than 3 months prior to the study)
effect of inhaled insulin (aerx® idms) on blood glucose control in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). this trial will compare the changes in hba1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone treatment alone.

the decision to discontinue the development of aerx® is not due to any safety concerns. an analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * current treatment with oral antidiabetes drugs (oads) for at least 2 months * hba1c between 7.0-11.0% if on oad monotherapy * hba1c between 7.0-10.0% if on oad combination therapy * bmi less than or equal to 40 kg/m2 exclusion criteria: * current regular smoking or regular smoking within the last 6 months * current acute or chronic pulmonary disease (except for asthma) * proliferative retinopathy requiring treatment * clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity * pregnancy
a study to investigate the effects of zelicapavir (edp-938) on qtc interval in healthy adults

Conditions: RSV Infection; QTc Interval

Summary: the purpose of the study is to assess the effect of a therapeutic and supratherapeutic dose of zelicapavir on the corrected cardiac qt interval relative to a placebo and positive control in healthy participants.


Eligibility criteria:
inclusion criteria: * an informed consent document signed and dated by the subject. * male or female individuals who are 18 to 65 years of age, inclusive * screening body mass index (bmi) of 18 to 30 kg/m2 with a minimum body weight of 50 kg * heterosexually active male participants and their female partners of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 90 days after the last dose of study intervention. * females of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 30 days after the last dose of study intervention. exclusion criteria: * clinically relevant evidence or history of illness or disease * clinically relevant risk factors for cardiovascular abnormalities * pregnant or nursing females * history of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection * infection with hiv, hbv, hcv, or sars cov 2 * any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy) * before the first dose of study intervention, participant has received any vaccine, an investigational agent or biological product within 28 days or 5 times the terminal half-life (t½), whichever is longer * a positive urine drug screen at screening or day -1 * current tobacco smokers or use of tobacco within 3 months prior to screening * history of regular alcohol consumption
bli, nbi or white light colonoscopy for proximal colonic adenoma

Conditions: Colon Adenoma

Summary: this is a prospective randomised trial comparing the proximal adenoma detection rate and miss rate by blue laser imaging (bli), narrow band imaging or white light colonoscopy.

study population: consecutive adult patients, age 40 or above, undergoing outpatient colonoscopy in the queen mary hospital are invited to participate in this prospective randomized study. patients are excluded if they are unable to provide informed consent or have undergone previous colorectal resection, or have personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, peutz-jeghers syndrome, or other polyposis syndromes. patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses will be excluded. in addition, patients are excluded post-randomization if either the cecum could not be intubated for various reasons or boston bowel preparation scale (bbps) score is \<2. study design and randomization: this is a prospective randomized crossover trial comparing the proximal adenoma detection rate and miss rate of bli (eluxeo endoscopic system) vs nbi (290 video system) vs wli which is conducted in the endoscopy center of the queen mary hospital of hong kong. eligible patients are randomly allocated to four groups in a 1:1:1 ratio to undergo tandem colonoscopy of the proximal colon, defined as cecum to splenic flexure. the three groups are: (1) nbi follow by wli; (2) bli follow up wli; (3) wli follow by wli. randomization will be carried out by computer generated random sequences and stratified according to endoscopist's experiences (experienced versus fellows) and indications of colonoscopy (symptomatic vs screening/surveillance). all procedures are performed with high-definition endoscopes. the patients are blinded to the group assignment.

Eligibility criteria:
inclusion criteria: * age 40 or above * scheduled for colonoscopy exclusion criteria: * unable to provide informed consent * have undergone previous colorectal resection, * personal history of colorectal cancer, inflammatory bowel disease, familial adenomatous polyposis, peutz-jeghers syndrome, or other polyposis syndromes. * patients who are considered to be unsafe for polypectomy including patients with bleeding tendency and those with severe comorbid illnesses * poor bowel preparation

Keywords: colonoscopy
comparison of saphenous vein graft harvested from upper versus lower leg in coronary artery bypass grafting

Conditions: Triple Vessel Disease; Unstable Angina; Stable Angina; Myocardial Infarction

Summary: in coronary artery bypass grafting, saphenous veins are widely used as a composite grafts that are y-anastomosed to in-situ left internal thoracic artery. based on our observation that remodeling of saphenous vein graft differs between those harvested from upper leg vein and lower leg, this study aims to compare histologic and immunohistochemical findings between saphenous vein grafts harvested from upper leg and lower leg.

inclusion criteria: * patients aged from 40 to 75 years with triple vessel disease * patients who are eligible for the use of left internal thoracic artery as an in situ primary conduit * operation plan: saphenous vein graft will be y-anastomosed to left internal thoracic artery. * patients whose saphenous vein grafts can be harvested from both upper legs and lower legs * patients who are eligible for off-pump coronary artery bypass grafting * patients who agreed with the participation in the research based on thorough explanation. patients will be randomly assigned to upper leg vein (ulv) group and lower leg vein (llv) group immediately after anesthetic induction. pieces of residual saphenous vein graft will be sent for histologic and immunohistochemical examination for the evaluation of endothelial cell preservation and the expression of matrix proteins.

Eligibility criteria:
inclusion criteria: * patients with multivessel disease who were planned to undergo off-pump coronary artery bypass grafting * patients whose left internal thoracic arteries can be used, and whose saphenous vein grafts will be y-anastomosed to left internal thoracic arteries. * patients whose saphenous vein grafts can be harvested from both upper and lower legs. exclusion criteria: * patients with overt heart failure symptoms * patients with intractable ventricular arrhythmia * patients with history of cancer or malignancy * patients with coagulation or other hematologic disorder * patients who needs concomitant cardiac procedures

Keywords: saphenous vein graft composite graft coronary artery bypass grafting graft remodeling
a study on traditional chinese medicine (tcm) comprehensive protocol of prevention and control in diabetic retinopathy

Conditions: Diabetic Retinopathy

Summary: 1. title: a study on tcm comprehensive protocol of prevention and control in diabetic retinopathy. 2. objectives of study: to evaluate the intervention effect of integrate control protocol on reducing the incidence rate of proliferative diabetic retinopathy, prp and mvl. then produce a high performance, optimize, convenient, applicable and demonstrated protocol of integrate control with intervention of tcm and west medicine. 3. study type: interventional 4. study design: multi-center, randomized, blind (subject, investigator, outcomes assessor), parallel assignment, positive controlled clinical study. 5. sample size: 480 subjects , divided into test and control groups equally. 6. primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation

1. primary outcome: * proliferative diabetic retinopathy * panretinal photocoagulation 2. secondary outcome: * vision, funduscopy, fundus photograph * fundus fluorescein angiography * visual electrophysiology:ferg、ops、pvep. * optical coherence tomography. * symptoms scores of tcm. * the m0s short-form-36 heaith survey(sf-36). * visual function questionnaire-25(vfq-25).

Eligibility criteria:
inclusion criteria: * diagnosed with diabetes mellitus. * diagnosed with non-proliferative diabetic retinopathy, including moderate and severe diabetic retinopathy * and corrected va≥45 letters(etdrs), equivalent the decimal value of 0.16(20/125). * diagnosed with the syndrome and signs of tcm. * hba1c≤8.0%. * ages ranged from 35 to 75 years. * joined in the test voluntarily and signed the informed consent by gcp regulation. exclusion criteria: * complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment. * the patients who have been received the therapy of retina laser photocoagulation. * the patients whose dioptric media is so turbid that hard to evaluate the fundus picture. * dmka or other acute metabolic disturbance, or complicating severe acute infection within a month. * combined with other severe diabetic complication. * having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness * pregnant or breast feeding. * combined with primarily severe diseases such as cardiovascular, hepatic，renal illness ,hemopoietic system disease, and psychosis. * combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc. * participated in other clinical trial within 3 month.

Keywords: diabetic retinopathy traditional chinese medicine
early results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness

Conditions: Intermittent Exotropia

Summary: this study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness

this prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. measurements of preoperative and postoperative deviation angle, stereopsis was performed.

Eligibility criteria:
inclusion criteria: * patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more * patients with follow up duration greater than 6 months exclusion criteria: * patients with previous ocular or strabismus surgery * patients with ocular or neurologic pathologic conditions * follow up duration less than 6 months
microtransplantation in older patients with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to see whether hla-mismatched donor cells infusion with chemotherapy (microtransplantation，mst) could increase complete remission (cr) and improve survival in older patients with acute myeloid leukemia (aml)，the investigators conducted a prospective, multicenter clinical trial of hla-mismatched mst to estimate outcomes and toxicities.


Eligibility criteria:
inclusion criteria: * de novo acute myeloid leukemia * age 60-90 * have hla mismatched donor exclusion criteria: * have no suitable donor or donor refused * patient refused to accept donor cells
sibling oocyte study of medium for in vitro fertilization/intracytoplasmic sperm injection (ivf/icsi) with no human serum albumine

Conditions: In Vitro Fertilization; Infertility

Summary: the purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for ivf/icsi.

cells attained in ivf/icsi procedures are kept in a medium that nurture the cells. until now all such media have contained human serum albumine. the purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for ivf/icsi.

Eligibility criteria:
inclusion criteria: * couples seeking ivf/icsi. * female under 38 years of age. * no more than two previous ivf/icsi treatments without pregnancy. * regular menstruation periods. * no endocrine disease that requires treatment in the female. * bmi below 30 in the female. * at least 8 mature follicles upon monitoring or 6 mii oocytes upon icsi. * written informed consent. exclusion criteria: * low responders to fsh. * females in danger of developing ohss. * sperm sample below icsi-quality.

Keywords: cell culture techniques
study of montelukast and its effect on lower leg growth in children with asthma (mk-0476-254)

Conditions: Asthma, Bronchial

Summary: the purpose of this study is to determine the effect of montelukast, an approved medication, on the lower leg growth rate in children with mild asthma. the primary hypothesis is that the lower leg length (lll) growth rate for children treated with montelukast compared to placebo will be established.

this is a crossover study that consists of a 2-week placebo run-in period, then a first 3-week treatment period, then a 2-week washout period, and then a second 3-week treatment period. participants will be randomized to treatment with either montelukast and placebo or budesonide and placebo. the duration of treatment is 6 weeks.

Eligibility criteria:
inclusion criteria: * a 6-month history of asthma with periodic episodes requiring treatment. exclusion criteria: * medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.
switching from insulin glargine to insulin degludec in subjects with type 2 diabetes mellitus (begin™)

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this clinical trial is to assess the implications of switching from insulin glargine (iglar) to insulin degludec (ideg) in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (diagnosed clinically) for at least 6 months * hba1c maximum 10 % by central laboratory analysis * current treatment with basal-oral therapy (bot) (no prandial insulin ever) consisting of: at least three months with insulin glargine once daily (average prescribed dose must have been unchanged (within plus/minus 10%) for four weeks prior to visit 1 as confirmed by patient records or verbal confirmation by the subject) in combination with stable (unchanged doses for at least 3 months prior to visit 1) oad (metformin, insulin secretagogues, pioglitazone, sitagliptin or alpha-glucosidase-inhibitor) treatment in any approved (according to label) dose or combination exclusion criteria: * use within the last three months prior to visit 1 of: exenatide, liraglutide or thiazoledinediones (tzds) other than pioglitazone * cardiovascular disease (cvd) defined as: stroke; decompensated heart failure new york heart association (nyha) class iii or iv; myocardial infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty within the last six months prior to visit 1 * recurrent severe hypoglycaemia (more than one severe hypoglycaemic episode during the last 12 months), or hypoglycaemic unawareness as judged by the investigator, or hospitalisation for diabetic ketoacidosis during the previous six months * pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures according to local requirements * previous participation in this trial. participation is defined as started on trial medication. rescreening of screening failures is allowed only once within the limits of the recruitment period * known or suspected hypersensitivity to trial products or related products
a phase 1 study to estimate the relative bioavailability and food effect of pf-04620110 in healthy adult subjects

Conditions: Healthy Volunteers

Summary: pf 04620110 is an acylcoa:diacylglycerol acyltransferase 1 (dgat1) inhibitor that is being developed for the treatment of type 2 diabetes mellitus (t2dm). it is anticipated that pf 04620110 will have anti diabetic effects through inhibition of intestinal triglyceride absorption and potentially weight loss. the primary purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of multiple oral formulations of pf 04620110 administered to healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests). * women must be of non childbearing potential. * body mass index (bmi) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at screening. * any condition possibly affecting drug absorption (eg, gastrectomy). * a positive urine drug screen.
continuous versus conventional volume management during crrt (continuous renal replacement therapy)

Conditions: Continuous Renal Replacement Therapy

Summary: use of on-line blood volume monitoring during continuous renal replacement therapy can improve volume management in acute kidney injury patients requiring renal replacement


Eligibility criteria:
inclusion criteria: * patients with kidney injury requiring continuous renal replacement therapy and volume removal exclusion criteria: * unable to provide or obtain patient consent * not expected to survive 48 hours

Keywords: volume acute kidney injury continuous renal replacement
evaluation of the effect of azd5069 in patients with bronchiectasis

Conditions: Bronchiectasis; Lung Disease; Respiratory Diseases

Summary: the purpose of this study is to investigate the effect of azd5069 in patients with bronchiectasis.


Eligibility criteria:
inclusion criteria: * male, or female of non-child bearing potential; ie, women who are permanently or surgically sterilised or post-menopausal. * aged 18 to 80 years inclusive at screening (visit 1) * have a clinical diagnosis of idiopathic or post infective bronchiectasis as diagnosed with a historical high resolution computerised tomography (hrct) or bronchogram * be sputum producers with a history of chronic expectoration on most days of most weeks of the year. patients should have a history of spontaneously producing sputum on a daily basis and should be able to provide at least 2 of the 3 required baseline sputum samples with an average of 3 ml or more. * be on a stable treatment regimen, as judged by the investigator. exclusion criteria: * any clinically significant disease or disorder * patients with other latent or chronic infections or at risk of infection within 90 days before visit 2 * an acute exacerbation or acute respiratory infection (upper or lower) requiring oral steroids or antibiotics within 30 days prior to visit 2 * an fev1 of \<30% of predicted normal at visit 1 * patients who have received live or live-attenuated vaccine in the 2 weeks prior to dosing (visit 2) * concomitant diagnosis of significant pulmonary disease other than bronchiectasis or copd, including symptomatic asthma and allergic bronchopulmonary aspergillosis * bronchiectasis associated with a generalised immunodeficiency disorder, where manifestations other than bronchiectasis predominate

Keywords: bronchiectasis neutrophil respiratory disease sputum
molecular-functional imaging of hypoxia in childhood sarcomas

Conditions: Rhabdomyosarcoma; Non-Rhabdo. Soft Tissue Sarcoma

Summary: this study will test the feasibility of using novel/existing imaging technologies focused on hypoxia measurements to determine "response to therapy" in pediatric soft tissue sarcomas as a pilot study. specifically, the investigators will compare the sensitivity of blood oxygen level dependent \[bold\], diffusion-weighted \[dw\] mri and magnetic resonance spectroscopy (mrs) with that of conventional mri to detect measurement changes between the start and completion of neoadjuvant therapy ("response to therapy") in children and adolescents (6-18 years) with suspicion of sarcoma tumors. clinicians and scientists may use results of the proposed hypoxia-imaging surrogate markers to adjust/modify therapeutic schemes to patients on a personalized basis.


Eligibility criteria:
inclusion criteria: * referred with a confirmed or suspected sarcoma tumor (rhabdomyosarcoma \[rms\] or non-rhabdomyomatous sarcoma) presenting with an extra-osseous component; * candidate for neoadjuvant therapy that will consist of standard systemic chemotherapy with or without radiation therapy exclusion criteria: * patients with general contraindications for an mri scan (metal foreign body, pacemaker, inability to tolerate an examination without sedation); * patients with a known immunodeficiency/sickle cell disease/collagen vascular disease/another malignancy; * patients with no clinical indication for neoadjuvant therapy prior to surgery; * patients with chronic pulmonary disease; * patients with other diagnosis confirmed after initial suspicion of rms or non-rms.