Kornimate/medical-research-clean huggingface dataset:
efficacy/safety of vildagliptin and metformin combination therapy in patients with type 2 diabetes not well controlled with metformin alone

Conditions: Diabetes Mellitus, Type 2

Summary: this study is designed to evaluate the efficacy and safety of vildagliptin in combination with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * 18-78 years inclusive * type 2 diabetes diagnosis at least 2 months prior to study entry * body mass index in the range of 22-45 kg/m2 * hba1c in the range of 6.5 to 9% inclusive * fasting plasma glucose \<270 mg/dl (15 mmol/l) exclusion criteria: * a history of type 1 diabetes * evidence of significant diabetic complications * treatment with insulin or any other oral antidiabetic agents * congestive heart failure requiring pharmacologic treatment * clinically significant renal dysfunction defined by metformin labeling criteria (serum creatinine levels \>/= 1.5 mg/dl (males) and \>/= 1.4 mg/dl (females) other protocol-defined inclusion/exclusion criteria may apply

Keywords: type 2 diabetes vildagliptin hemoglobin a1c metformin
the effect of monoclonal vascular endothelial growth factor (vegf) antibody (bevacizumab) on pituitary function

Conditions: Colorectal Cancer; Lung Cancer; Breast Cancer; Glioblastoma

Summary: the purpose of this research is to determine whether the drug, bevacizumab (a monoclonal anti vegf-a antibody), which is approved to treat patients with metastatic colon cancer induces hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function. past studies have shown bevacizumab to shrink tumor size and also increase prolactin levels. the mechanism of the hyperprolactinemia might be inhibition of pituitary portal vein transport, suggesting that bevacizumab induces prolactin secretion from normal lactotrophs in the pituitary gland. patients who have been treated with bevacizumab for at least one month will be recruited to participate. the subjects who are being treated with bevacizumab by dr. stephen wolin (a sub-investigator) will be screened by him for study eligibility. dr. wolin will approach eligible patients with all the information and background of the study and see if they have an interest in being consented. if consented, there will be 2 blood draws for the research that is not part of their standard care in which 10 ml of blood is collected and prolactin, growth hormone, igf-i, tsh, thyroxine, acth, and cortisol will be measured. one 5ml blood draw will occur before the administration of bevacizumab and the second 5 ml blood draw will occur after the administration of the bevacizumab. the investigators will then review the laboratory results. the blood tests are of the hormones of the pituitary gland to test pituitary function and see if there are any abnormalities with the secretions of the gland. pituitary function abnormalities and hyperprolactinemia are diagnosed by looking at hormone levels in the blood and comparing them to the normal reference ranges. this study will only involve 10 subjects and will be conducted entirely at cedars-sinai medical center.


Eligibility criteria:
inclusion criteria: * patients with colorectal cancer, lung cancer, breast cancer, and glioblastoma patients that have been treated with bevacizumab for at least 1 month * adults (18 years of age or older) exclusion criteria: * patients who are taking medications known to affect serum prolactin levels * patients who are pregnant * patients who have pituitary disease * minors (under the age of 18)

Keywords: bevacizumab
a study to investigate the safety and tolerability of single and multiple ascending doses of kit2014 in healthy subjects

Conditions: Cystic Fibrosis

Summary: this is the first-in-human study with kit2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.

this is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled kit2014 administered via nebulizer to healthy adult participants. the study will be conducted in 2 parts, part a (single ascending dose, sad) and part b (multiple ascending doses, mad).

Eligibility criteria:
major inclusion criteria: 1. must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. adult males and females, 18 to 55 years of age (inclusive) at screening. 3. bmi ≥ 18.0 and ≤ 32.0 kg/m2, with a body weight of at least 60 kg for males and 50 kg for females. 4. medically healthy, as determined by pre-study medical history, and without clinically significant abnormalities. 5. normal spirometry results at screening based on fev1 ≥ 80% of predicted, fvc ≥ 80% of predicted and fev1/fvc ratio ≥0.70. major exclusion criteria: 1. history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, determined by the pi to be clinically relevant. 2. any respiratory infection or relevant respiratory problem within 14 days of day 1. other inclusion/exclusion eligibility criteria apply.
point-of-care ultrasound screening and assessment of chronic liver diseases and nash

Conditions: Liver Diseases; Liver Cirrhosis; NASH - Nonalcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Fibrosis, Liver; Steatosis of Liver

Summary: the main objective of the study is to determine the diagnostic performances of an ultraportable diagnostic ultrasound system for the assessment of liver fibrosis severity in patients with nash, and to compare them to other non-invasive tests.

this is a prospective cross-sectional study that will recruit approximately 1000 patients across 30 clinical sites in europe and the usa. the target recruited population will include adult patients at risk of, or with known chronic liver diseases, whether or not screened for inclusion in nash pharmaceutical trials. after being informed about the study objectives and potential risks, patients who consent to participate will undergo an non-invasive external ultrasound exam of their liver using an ultraportable diagnostic ultrasound system. the system will derive quantitative information related to physical and acoustic properties of the liver tissue, which are known to correlate with the severity of chronic diffuse liver diseases such as fibrosis and steatosis. the study will also assess the repeatability, reproducibility and robustness of quantitative parameters. collected data will also enable exploring ultrasound-based liver tissue characterization correlated to nash-specific histological lesions such as intra-hepatic inflammation and hepatic cell ballooning.

Eligibility criteria:
inclusion criteria: * any of the following criteria: * patients with known chronic liver diseases referred to liver-specific exams by their referring physician as part of the routine practice, including a vcte exam, with or without a blood test, a mri/mre exam, a liver biopsy, * patients screened for fibrotic nash in the context of nash pharmaceutical trials, for which a data sharing agreement has been signed between e-scopics and the pharmaceutical trial promoter, * patients who consent in written to participate in the clinical investigation after being orally informed on the objectives and methods of the clinical investigation, * european patients covered by a social security program exclusion criteria: * patients under 18 years of age or over 80 years of age, * patients with active implants such as pacemakers, defibrillators, pumps, etc. * patients presenting wounds at the location where the es1 probe shall be placed on patients' skin, * adult patients under social tutorship, or unable to provide informed consent when not subject to tutorship measures, * pregnant and breastfeeding women, * people deprived of their freedom rights * people who have been hospitalized without giving informed consent or under emergency situation, * people admitted in a social or sanitary institution for other reasons than the clinical investigation, * patients included in another research study that could interfere with the present clinical investigation.

Keywords: elastography ultrasound attenuation sound speed ultrasound
evaluation of an early screening test of chronic rejection and of operational tolerance by microarray in renal graft (protocol dprc array)

Conditions: First Cadaveric Renal Graft

Summary: the aim of the study is to explore the possibility to identify, at an early stage after a renal graft and from blood samples collected within first months after graft, a predictive transcriptional profile of long term occurence of graft operational tolerance or chronic rejection. the aim of the study is to determine an early transcriptional profile of chronic rejection in the transcriptome of mononuclear blood cells. validation and predictivity of transcriptional analysis will be based on graft function and graft histology one year after transplantation.the other aim is to determine an early transcriptional profile of operational tolerance in the same patients using a dna chip dedicated including two lists of genes discriminating tolerant patients who are stopped immunosuppressant treatment for over a year. to allow statistical analysis of 100 patients followed one year after graft, patients not assessable at one year due to early termination of study will be replaced.


Eligibility criteria:
inclusion criteria: * patients aged 18 to 65 years old, * donor's age ≤ 60 years old, * patients receiving a first cadaveric renal graft, * patients taking immunosuppressant treatment including an induction with simulect at day 0 and day 4, fk 506 (prograf®) associated with cellcept and steroids (for three months), * patients don't taking indispensable anticoagulant treatment. exclusion criteria: * patient's age \ 65 years old, * donor's age ≥ 60 years old, * pregnant women or breast feeding women, * patients receiving a retransplantation, a kidney and pancreas graft or a graft from a living donor, * patients taking immunosuppressant treatment without fk 506 (prograf®), cellcept and steroids. * patients with coagulation troubles or taking indispensable anticoagulant treatment, * no biopsy before graft.

Keywords: renal graft chronic rejection tolerance dna chip biopsy
impact of ranolazine on coronary microcirculatory resistance

Conditions: Coronary Microcirculation; Coronary Artery Disease; Myocardial Disease; Ischemia

Summary: this study is being done to determine if ranolazine treatment improves coronary microcirculation function among patients with coronary microcirculation dysfunction. we are also looking to learn if symptomatic improvement of chest pain during treatment with ranalozine is related to improved coronary microcirculation function.


Eligibility criteria:
inclusion criteria: * - patients with subjective symptoms of ischemia without flow limiting angiographic cad (\ 20 u). * definition of ischemia (any one): * chest pain with dynamic ischemic ecg changes (t wave inversions or \> 1 mm st depressions * exercise treadmill testing induced chest pain with ≥1 mm of downsloping or flat st segment depression during exercise or recovery; ≥2 mm of ischemic st depression at a low workload (stage 2 or less or ≤130 beats/min); early onset (stage 1) or prolonged duration (\>5 min) of st depression; multiple leads (\>5) with st depression * nuclear stress perfusion defect \> 10% * stress echocardiogram with stress induced wall motion abnormality exclusion criteria: * - age \< 18 yrs * flow limiting epicardial cad \>50% * life expectancy \< 6 months * recent (\<1 week) myocardial infarction or positive biomarkers * severe aortic stenosis * contraindications to imr testing including inability to utilize antithrombotic therapy and/or intravenous adenosine * contraindications to ranolazine therapy: * patients with known hepatic insufficiency, prolonged qt or renal failure (gfr \< 60) * use of drugs that inhibit cyp3a such as diltiazem, verapamil, ketoconazole, macrolides and hiv protease inhibitors * pregnancy, breastfeeding * patients taking drugs which prolong qt interval

Keywords: coronary microcirculation coronary artery disease myocardial disease ischemia
the effect of diet on microbial profile and disease outcomes in patients with inflammatory bowel diseases

Conditions: Inflammatory Bowel Diseases; Crohn's Disease; Dietary Modification

Summary: this clinical study is designed to evaluate the effect of two dietary patterns, mediterranean diet and the specific carbohydrate diet on clinical, inflammatory and microbial parameters in patients after pouch surgery and to assess the effect of a personal tailored diet, based on microbial profile, on disease outcomes and generate a predictive model for future interventions.

increasing evidence exist regarding the role of diet in the pathogenesis of inflammatory bowel diseases. one possible mechanism for the effect of diet on intestinal inflammation is modification of the gut microbial composition. however, the relationship between diet, the microbiome and intestinal inflammation is still vague. the investigators plan to perform a crossover clinical trial. seventy ulcerative colitis patients post restorative proctocolectomy (pouch) will be randomly allocated into two short-term (one week) dietary interventions, the mediterranean diet and the specific carbohydrate diet, to assess which diet has the required influence (i.e. increased diversity, decrease in specific pathobionts and increase in "anti-inflammatory" taxa) on the gut microbiome of each participant. based on this assessment, each participant will be treated by a personally-tailored diet for up to one year, during which microbial composition, clinical parameters, and quality of life will be assessed.

Eligibility criteria:
inclusion criteria: * patients aged 18-75; * able and willing to sign an informed consent; * underwent pouch surgery because of refractory uc or familial adenomatous polyposis (fap) and have a functioning pouch. exclusion criteria: * patients with ileostomy, stricturing disease, use of antibiotics in the month prior to inclusion, significant comorbidity that precludes the patient from participating according to the physicians' judgment, non-hebrew readers, pregnant and lactating women.
cares-hcv: promoting screening uptake among diverse baby boomers

Conditions: Hepatitis C Virus Infection; Colorectal Cancer

Summary: the purpose of the study is to examine the efficacy of educational materials to promote hepatitis c virus (hcv) screening and colorectal cancer (crc) screening uptake among adults born between 1945-1965.


Eligibility criteria:
inclusion criteria: * born between 1945 and 1965 and up to age 75 * no personal history of colorectal cancer (crc) or current presumptive colorectal cancer symptoms (e.g., unresolved rectal bleeding or abdominal pain/bloating) * no personal history of hepatitis c virus (hcv) or liver cancer * able to read, write, speak, and understand english or spanish * not currently enrolled in another crc screening or a hcv screening study * at average risk for crc (that is, no hereditary crc syndromes such as lower gastrointestinal (gi) bleeding, persistent diarrhea, bloating, or lower gi pain, no strong family history of crc) * not currently up-to date with crc screenings * not having previously completed hcv screening * able and willing to complete a phone interview * able to provide informed consent

Keywords: hcv screening crc screening
effect of remimazolam on postoperative nausea and vomiting

Conditions: Postoperative Nausea and Vomiting

Summary: the present trial is to study the effect of low dose remimazolam on postoperative nausea and vomiting (ponv) in patients at risks of ponv (women, postoperative use of opioid, nonsmokers) undergoing laparoscopic cholecystectomy.

postoperative nausea and vomiting (ponv) is a common complication in patients undergoing general anesthesia. it is reported that ponv is observed in 50% of patients 24 hours after general anesthesia and upto 80% in high risk patients. the patients experiencing ponv may experience severe discomfort that it is important to prevent ponv. there are several prophylactic agents for ponv. 5 serotonin receptor antagonist(5-ht3 antagonist) is the most commonly used agent and other agents such as corticosteroid, neurokinin-1 receptor antagonist can also be used. previous studies have reported the efficacy of benzodiazepine(midazolam) in a low targeting dose as a prophylactic agent of ponv. the efficacy of low dose remimazolam (short acting benzodiazepine) on ponv has not been evaluated. according to fourth consensus guideline for the management of postoperative nausea and vomiting (2020), three prophylactic anti-emetics are recommended for patients with three or more of the risk factors of ponv. as the patients included in our study have three or more of risk factors of ponv (women, postoperative use of opioid, nonsmokers), three prophylactic anti-emetics are recommended. our center has routinely been using 5-ht3 receptor antagonist (ramosetron) and corticosteroid (dexamethasone) for women undergoing laparoscopic cholecystectomy. however, we still find many patients complaining nausea and vomiting after operation. therefore, we are willing to investigate the low supplemental dose of remimazolam on the prophylaxis of ponv.

Eligibility criteria:
inclusion criteria: * women undergoing laparoscopic cholecystectomy under general anesthesia. exclusion criteria: * moderate to severe liver dysfunction (total bilirubin ≧ 3.0 mg/dl / aspartate aminotransferase(ast) or alanine aminotransferase(alt) ≧ 2.5 times more than normal range) * moderate to severe renal dysfunction (serum creatinine ≧ 2.0 mg/dl / end-stage renal disease undergoing hemodialysis) * tolerance to benzodiazepines * hypersensitivity to anesthetic drugs (benzodiazepines, propofol, remifentanil, fentanyl citrate, rocuronium bromide, flumazenil) * acute angle glaucoma * alcohol dependence * galactose intolerance, lactase deficiency, glucose-galactose malabsorption * pregnant, breast feeding women * bmi \>35 kg/m2 * uncontrolled diabetes mellitus
impact of sacral neuromodulation on urine markers for interstitial cystitis (ic)

Conditions: Interstitial Cystitis

Summary: urine will be collected and sent to the university of maryland. urines will be analyzed for urine markers.

urine will be collected and flash frozen in liquid nitrogen then placed in a -70 c freezer. all urine will be collected and stored until the final follow-up is complete. the urine samples will then be sent as a single batch to the department of infectious disease, university of maryland. urines will be assayed in a blinded fashion and a written report of the levels of each of the 3 urine markers will be sent to beaumont hospital. change in urine marker levels will be analyzed and correlated with change in symptom scores.

Eligibility criteria:
inclusion criteria: * patients will be drawn from dr. peters patient base that covers southeast michigan. exclusion criteria: * male

Keywords: interstitial cystitis ic sacral nerve stimulation
an intervention effect study of a mobile medical supportive care program for family caregivers with dementia combined with diabetes: a randomized controlled trial

Conditions: Diabetes; Senile Dementia, Alzheimer Type

Summary: the purpose of this project is to evaluate the effectiveness of the clinical application of a mhealth supportive care program for family caregivers with dementia combined with diabetes based on the supportive care framework. the results of the study will provide family caregivers with more economical and efficient care guidance, thereby improving the quality of care and quality of life for people with dementia and diabetes in general.


Eligibility criteria:
inclusion criteria: caregivers: ① caregivers and patients have legal kinship (such as spouses, children or siblings) and other non-costly caregivers such as babysitters, bellhops, etc.; ② caregiving work ≥ 8 hours / day, care for the patient ≥ 5 days a week, the care time ≥ 1 month; ③ conscious adults with a certain degree of reading and comprehension; ④ at least have a smart phone (with internet access) and will be able to use it proficiently; ⑤ informed consent and voluntary participation in the study. informed consent and voluntary participation in the study. targets: ① meet the diagnostic criteria of alzheimer's disease; ② meet the diagnostic criteria of type 2 diabetes mellitus; ③ age ≥ 60 years old, permanent residents of the district. exclusion criteria: caregivers: ① severe physical or mental illness; ② people with drug or alcohol dependence; ③ caregivers who are participating in a similar intervention study. caregivers: ① patients with severe physical illnesses, major illnesses, or terminal illnesses; ② patients with drug or alcohol dependence.

Keywords: dementia diabetes family caregivers mobile healthcare supportive care programs a randomized controlled trial
distal targeter vs free-hand

Conditions: Femur Fracture; Tibial Fractures; Nonunion of Fracture; Nonunion of Fracture of Tibia; Nonunion of Fracture of Femur (Diagnosis); Tibia Fracture

Summary: this study is a randomized controlled trial comparing the use of two different surgical techniques--free-hand versus distal targeting jig-based for distal interlock screw--placement and their effects on total operative time and intraoperative radiation exposure.

interlocking screw placement in intramedullary nailing of femoral and tibial shaft fractures improves rotational and length stability. however, free-hand perfect circle techniques can be technically challenging and may take up to an hour with increased radiation exposure to the surgeon and patient. newer technologies aimed at reducing fluoroscope use such as electromagnetically-based aiming devices may increase the operative time. proximally-based jigs have been shown to reduce fluoroscopy time in cadavers, however, have not been studied clinically. this study is a prospective, randomized controlled trial comparing a modern proximally-based distal targeting device and free-hand techniques for placement of interlocking screws in lower extremity nailing.

Eligibility criteria:
inclusion criteria: * 18 years old and above * undergoing intramedullary fixation of femur or tibia shaft for acute fracture or nonunion exclusion criteria: * prior ipsilateral tibial or femoral nail * patients who cannot have interlocking screws placed * pregnant women

Keywords: femur fracture tibia fracture operative time screw placement jig