Kornimate/medical-research-clean huggingface dataset:
a study of alegitazar in patients with type 2 diabetes and chronic kidney disease (alerenal study)

Conditions: Diabetes Mellitus Type 2, Kidney Disease, Chronic

Summary: this randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. the anticipated time on study treatment is approximately 3 years.


Eligibility criteria:
inclusion criteria: * adult patients \>= 18 years of age at screening * diagnosis of diabetes mellitus type 2 * glycosylated hemoglobin a1c (hba1c) \< 10% at screening * estimated glomerular filtration rate (egfr) \>=30 and \< 60 ml/min/1.73 m2 * urinary albumin-to-creatinine ratio (uacr) \>=500 and \< 5000 mg/g * treatment with either angiotensin converting enzyme inhibitor or angiotensin ii receptor blocker for at least three months prior to screening * women of child-bearing potential using a highly effective birth control method must be willing to use the same method of contraception during the entire course of the study exclusion criteria: * treatment with a ppargamma agonist and/or pparalpha agonist in the last 12 weeks screening * prior intolerance to a tdz or fibrate * previous participation in a trial with aleglitazar * diagnosis or history of other types of diabetes * diagnosis or history of acute metabolic diabetic complications within the past 6 months * known primary glomerulonephritis, secondary glomerulonephritis other than diabetic nephropathy or polycystic kidney disease * diagnosed acute kidney injury or dialysis within 12 weeks prior to screening * poorly controlled hypertension (systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 100 mmhg at baseline) * known secondary hypertension due to renal artery stenosis, primary aldosteronism, or pheochromocytoma * history of myocardial infarction or stroke in the past 12 weeks prior to screening * symptomatic congestive heart failure nyha class ii-iv at baseline or heart failure leading to hospitalization within the 12 months prior to screening * diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years * inadequate liver and hematological function * chronic treatment with immunosuppressive therapy * women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective birth control methods
west hertfordshire inflammatory bowel disease technology study

Conditions: Inflammatory Bowel Diseases

Summary: a retrospective and prospective, observational, non-interventional, cohort study to develop quantitative metrics from tools used as standard of care when diagnosing, assessing and monitoring patients with inflammatory bowel disease.

inflammatory bowel disease is a chronic inflammatory disease of the gastrointestinal tract that is without cure. it comprises two main disorders: crohn's disease and ulcerative colitis. these conditions can lead to debilitating symptoms of abdominal pain, weight loss, diarrhoea and rectal bleeding. the incidence of inflammatory bowel disease is increasing worldwide and is increasingly considered an emerging global disease. the prevalence of inflammatory bowel disease is currently the highest in north america and western europe and up to 600,000 people in the united kingdom are thought to be affected. the diagnosis and monitoring of inflammatory bowel disease is based on clinical, endoscopic, radiological and histological features. endoscopy, is considered the current gold standard in inflammatory bowel disease with newer techniques being developed. there are however limitations to these methods, especially regarding the inter and intra observer variability in assessing the validated scoring systems used from the gold standard modalities.

Eligibility criteria:
inclusion criteria: * male or female aged 16 or over * patients with known or suspected inflammatory bowel disease scheduled to undergo clinical, endoscopic or radiological assessment * patients with known inflammatory bowel disease under ongoing clinical monitoring, who have previously undergone clinical, endoscopic or radiological assessments. * participant willing and able to give informed consent for participation in the study exclusion criteria: * participant who is, or suspects that they are, pregnant at the time of assessment * any other cause, including significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the participant's ability to participate in the study

Keywords: inflammatory bowel disease ulcerative colitis crohns disease artificial intelligence endoscopy pathology radiology
a retrospective clinical registry of peripheral nerve block

Conditions: Nerve Block; Regional Anesthesia; Postoperative Complications

Summary: locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. they provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay. the primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division. this is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. they provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay. however, peripheral nerve blocks may be associated with postoperative complications, especially neurological ones. classically, interscalene brachial plexus block produced a 100% incidence of phrenic nerve paralysis with resultant pulmonary compromise. little literature has published a following of complications. the primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division. the secondary objectives are assessed the patients characteristics of our sample, local anaesthetic dose used, the peripheral nerve block operator, the nerve location technique, the surgery and the complication rate after peripheral nerve block. this is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

Eligibility criteria:
inclusion criteria: * every patient who needs a peripheral nerve block performed by anestesia department. exclusion criteria: * patient refusal of peripheral nerve block. * known allergy to amide local anaesthetic drugs * absolute contraindications to perform a peripheral nerve block as coagulopathy, active infection at the block site or severe respiratory background.

Keywords: regional anesthesia postoperative neurological complications ultrasound nerve stimulator brachial plexus block
study on all-trans retinoic acid, induction and consolidation therapy, and pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this trial is a study on all-trans retinoic acid in combination with induction and consolidation therapy as well as pegfilgrastim after consolidation therapy in younger patients with newly diagnosed acute myeloid leukemia (aml).

first induction therapy: * cytarabine 100 mg/m² cont. i.v. days 1-7 * idarubicin 12 mg/m² i.v. days 1,3,5 * etoposide 100 mg/m² i.v. days 1-3 * ± atra 45 mg/m² p.o. days 6-8 * atra 15 mg/m² p.o. days 9-21 second induction therapy: * cytarabine 100 mg/m² cont. i.v. days 1-7 * idarubicin 12 mg/m² i.v. days 1 and 3 * etoposide 100 mg/m² i.v. days 1-3 * ± atra 45 mg/m² p.o. days 6-8 * atra 15 mg/m² p.o. days 9-21 consolidation therapy: cohort 1 (\<= id 336) * cytarabine 3 g/m² 2x/die i.v. tag 1,3,5 * ± atra 15 mg/m² p.o. tag 6-21 * pegfilgrastim 6 mg s.c day 10 cohort 2 (\> id 336) * cytarabine 3 g/m² 2x/die i.v. tag 1,2,3 * ± atra 15 mg/m² p.o. tag 4-21 * pegfilgrastim 6 mg s.c day 8

Eligibility criteria:
inclusion criteria: * newly diagnosed aml defined according to the world health organization (who)-classification (excluding acute promyelocytic leukemia \[apl\]) * ages 18-60 years * written informed consent of each patient at study entry. * molecular and cytogenetical diagnostics on initial bone marrow and peripheral blood specimen at the central reference laboratories exclusion criteria: * bleeding independent of the aml * acute promyelocytic leukemia * uncontrollable infection * participation in a concurrent clinical study * insufficiency of the kidneys (creatinine \> 1.5x upper normal serum level), of the liver (bilirubin, ast or ap \> 2x upper normal serum level), severe obstructive or restrictive ventilation disorder, heart failure new york heart association (nyha) iii/iv * severe neurological or psychiatric disorder interfering with ability to give an informed consent. * no consent for registration, storage and processing of the individual disease-characteristics and course. * performance status who \> 2 * pregnancy
a phase ib/ii study of ak104 and ak117 in combination with or without chemotherapy in advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: phase ib/ii open label, multicenter study to evaluate the efficacy and safety of ak104 (anti-pd-1 and ctla-4 bispecific antibody) and ak117#anticd47 antibody# combined with or without chemotherapy in advanced malignant tumors


Eligibility criteria:
inclusion criteria: 1. 18 to 75 years old. 2. have an eastern cooperative oncology group (ecog) performance status of 0 or 1. 3. have a life expectancy of at least 3 months. 4. phase ib: histologically or cytologically confirmed advanced solid tumor. 5. phase ii: has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or gej adenocarcinoma or esophageal squamous cell carcinoma. 6. have at least one measurable lesion based on response evaluation criteria in solid tumors (recist) 1.1 assessed by investigator. 7. has adequate organ function. exclusion criteria: 1. undergone major surgery within 30 days prior to the first dose of study treatment. 2. active central nervous system (cns) metastases. 3. history of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs). 4. active hepatitis b or hepatitis c. 5. received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity. 6. history of severe bleeding tendency or coagulation disorder.
role of cryotherapy in reduction of post operative endodontic pain following single visit root canal therapy

Conditions: Effects of; Cold

Summary: aim : to determine the efficacy of cold saline irrigation in reduction of post operative pain following root canal therapy. methodology : forty patients requiring root canal treatment on permanent single rooted teeth were included. the patients were assigned randomly into two groups of 20 patients each. the teeth in group1 (n = 20) were irrigated using normal saline solution, whilst those in group 2 (n = 20) were irrigated with cold saline solution stored at 4 degrees centigrade. a heft parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 12, 24,48 and 72 hours after obturation. chi square tests and mann whitney u tests were used for statistical analysis.


Eligibility criteria:
inclusion criteria: * above 18 years of age * healthy patients without any medical conditions exclusion criteria: * root canal retreatment * pregnancy * teeth with open apices * a history of intolerance to nonsteroidal anti-inflammatory drugs * immunosuppressed patients * those under 18 years old * patients requiring antibiotic prophylaxis * patients with pacemakers.
the university of michigan wellness for liver health study

Conditions: Nonalcoholic Fatty Liver Disease

Summary: the goal of this proposal is to pilot test our existing very-low carbohydrate diet intervention, adapted for adults with non-alcoholic fatty liver disease (nafld).

as there are no medications that effectively treat nonalcoholic fatty liver disease (nafld), effective diet and lifestyle treatments are imperative to curb this disease's impact. our data suggests that insulin resistance is the strongest modifiable risk factor for having nafld. additionally, genetic factors can interact with insulin resistance to multiplicatively increase risk of nafld. the investigators hypothesize that a very low-carbohydrate diet and behavioral support program may be able to achieve nafld reversal in adults with steatosis and/or mild fibrosis, especially in a subpopulation of rs738409-gg individuals. to prepare to test this, the investigators will conduct a pilot feasibility and acceptability trial of a 4-month online very low-carbohydrate, ketogenic (or keto) program in adults with nafld.

Eligibility criteria:
inclusion criteria: * have regular access to the internet * mri with liver steatosis but nor cirrhosis * able to consent and follow directions * no physical limitations * physician approval to participate * able to attend in-person appointments in ann arbor * be identified based on information from the michigan genomics initiative (mgi) database * have elevated liver function tests exclusion criteria: * non-english speaking * inability to complete baseline measurements * a substance abuse, mental health, or medical condition that would interfere with participation (such as current chemotherapy, heart failure, kidney failure, cushing's syndrome, etc.) * pregnant or planning to get pregnant in the next 6 months * type 1 diabetes * non-nafld causes of elevated liver function tests * planned or history of weight loss surgery * vegan or vegetarian * currently enrolled in a weight loss program or other investigative study that might conflict with this research * taking medications known to cause weight gain or loss * recent decompensation/hospitalization * metal implants/inability to receive mri

Keywords: nutrition
efficacy, safety, pharmacokinetics and immunogenicity study of abatacept administered intravenously to treat active polyarticular-course juvenile idiopathic arthritis in japan

Conditions: Juvenile Idiopathic Arthritis

Summary: the purpose of this study is to assess the efficacy of abatacept after intravenous administration in japanese children and adolescents with active juvenile idiopathic arthritis who have a history of an inadequate response or intolerance to methotrexate or biologics


Eligibility criteria:
inclusion criteria: * subjects who have a history of an inadequate therapeutic response or intolerance in the opinion of the examining physician to at least one biologics or methotrexate (mtx). * diagnosis of juvenile idiopathic arthritis (jia) by international league of associations for rheumatology (ilar) criteria as oligoarticular, polyarticular rheumatoid factor (rf+), polyarticular (rf-), or systemic with a polyarticular-course. * men and women, ages 4 to 17 years, inclusive at enrollment. * subjects must have a history of at least 5 joints with active disease and must have currently active articular disease as defined by: 1. ≥2 active joints (e.g. presence of swelling, or if no swelling is present, limitation of motion (lom) accompanied by pain, tenderness, or both) at screening and at week 0 (day 1). 2. ≥2 joints with lom at screening and at week 0 (day 1). exclusion criteria: * systemic onset jia with any of the following manifestations within the last 6 months prior to enrollment: intermittent fever due to jia, rheumatoid rash, hepatosplenomegaly, pleuritis, pericarditis, or macrophage activation syndrome. * presence of any other rheumatic disease or major chronic infectious/inflammatory/immunologic disease (e.g. inflammatory bowel disease, psoriatic arthritis, spondyloarthropathy, hypogammaglobulinemia, or systemic lupus erythematosus, etc.)
a study to investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine.

Conditions: Clostridium Difficile Associated Disease

Summary: this study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. the study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.


Eligibility criteria:
inclusion criteria: healthy male and female subjects aged 50 to 85 years exclusion criteria: proven or suspected prior episode of clostridium difficile associated diarrhea. unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine. any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.

Keywords: clostridium difficile vaccine
the effect of inspiratory muscle training on blood pressure and functional capacity in elderly with hypertension

Conditions: Elderly; Hypertension

Summary: the goal of this clinical trial is to investigate in elderly with hypertension . the main question it aim to answer is: • investigate the effect of inspiratory muscle training on inspiratory muscle strength, blood pressure and physical capacity participants will be random in to 2 group and measure baseline. control group will advise to maintain normal daily life activity. and intervention group will receive inspiratory muscle training (imt) with 60% of maximal inspiratory pressure. intervention group will perform imt 30 breaths/day, 5 days a week for 6 weeks. after 6 weeks both group will remeasure variable again as post test


Eligibility criteria:
inclusion criteria: * elderly with hypertension * bmi 18.5 - 29.9 kg/m2 exclusion criteria: * unstable angina * resting heart rate more than 120 bpm * resting blood pressure more than 180/100 mmhg * other abnormality with contribute to imt and variable measurement

Keywords: elderly hypertension inspiratory muscle training
cric combined with mft for cardiovascular adverse events in patients with incomplete revascularization of cad

Conditions: Coronary Artery Disease

Summary: the main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can reduce cardiovascular adverse events in patients with incomplete revascularization of coronary artery disease.


Eligibility criteria:
inclusion criteria: * 1) age ≥18 years old * 2) consistent with the diagnosis of coronary heart disease, complete revascularization was not performed (coronary angiography showed that at least one vessel with a reference diameter of 3.0mm had stenosis greater than 90%, and quantitative flow ratio (qfr) \< 0.80) * 3) symptoms of myocardial ischemia (resting or exertional angina; angina allele: chest tightness, shortness of breath, etc.); exclusion criteria: * age \< 18 years old * heart failure patients with nyha class iv, or left ventricular ejection fraction (lvef) \< 40% * creatinine clearance \< 30 ml/min (or egfr \< 30 ml/min/1.73m²), or requires dialysis * myocardial diseases such as hypertrophic cardiomyopathy, dilated cardiomyopathy, etc. * uncontrolled or recurrent arrhythmic events (e.g., ventricular fibrillation, recurrent or symptomatic sustained ventricular tachycardia, complete heart block, atrial fibrillation with rapid ventricular rates, supraventricular tachycardia refractory to drugs) * poorly controlled hypertension (sbp \> 180 mm hg or dbp \> 110 mm hg) * active liver disease or persistent alt or ast elevation ≥ 3 times the upper limit of normal * unexplained ck \> 5 times the upper limit of normal, or elevated ck due to known muscle disease * planned or anticipated cardiac surgery or revascularization before randomization * history of active malignancy (surgery, radiation therapy, and/or systemic therapy within the past 3 years) * diagnosed or suspected upper extremity vascular malformations, aneurysms, arteriovenous fistulas, or thrombosis * hearing impairment, unable to undergo mindfulness therapy * currently participating in another drug or device study, or within 30 days of completing another drug or device study or receiving another investigational drug * any life-threatening comorbid conditions expected to result in death within the next year (excluding cardiovascular diseases) * alcoholism, substance abuse history; and unwilling or unable to stop alcohol or substance abuse during the study * history of major organ transplant (e.g., lung, liver, heart, bone marrow, kidney) * investigator's judgment of known major active and uncontrolled disease, or any medical, physical, or surgical conditions (e.g., infection, significant blood, kidney, metabolic, gastrointestinal, or endocrine dysfunction) that may interfere with participation in the clinical study * as known to the investigator, the subject is unlikely to complete follow-up for more than 1 year or is expected to be unable to comply with the study requirements or understand the study's objectives and potential risks.
validation of a french quality of life questionnaire adapted to persons who have suffered a stroke

Conditions: Stroke

Summary: the aim of this work is to develop and validate a scale adapted to french cultural characteristics. it will be based on the ss-qol scale and be simple and quick to use in everyday practice. it is not simply a translation. this transcultural adaptation requires linguistic and psychometric validation, by studying its validity, its reliability and its sensitivity to change, as though it were a new instrument. the investigators will then develop a short version by reducing the items and conduct a psychometric validation. the translation and validation of a short french version of the ss-qol scale will generate a reliable and sensitive, easy-to-use tool suitable for use in everyday practice. the final objective is to use this tool as a principal judgement criterion in future therapeutic trials and in patients of the dijon stroke registry to bring to light prognostic factors that affect quality of life so as to provide better management of this disease.


Eligibility criteria:
inclusion criteria: * patients aged 18 years and older. * patients following a first stroke (ischemic or non-traumatic cerebral parenchyma haemorrhage) followed at a consultation at dijon chu and included in the dijon stroke registry cohort. * patients who have provided oral informed consent. * patients with national health insurance cover exclusion criteria: * history of symptomatic stroke. * meningeal haemorrhage. * severe visual or hearing handicap making it difficult to complete the questionnaire. * global severe aphasia and mutism making communication with the patient impossible-. * unable to read or speak french. * dementia prior to the stroke. * psychiatric disorders and dependence on alcohol/drugs. * bedridden before the stroke. * other comorbidities considered severe by the clinician and not related to the stroke that could have significantly impaired quality of life before the stroke.