Kornimate/medical-research-clean huggingface dataset:
the impact of vitamin d supplementation on pregnant women with the risk of gdm

Conditions: Gestational Diabetes Mellitus

Summary: a clinical trial will be conducted in chemical pathology department in collaboration with gyne \&obs department of prh, iimc over a period of 02 years w.e.f. december 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for gdm with low vitamin d3 levels and normal response to 75g ogtt will be randomly assigned to receive either vitamin d3 supplementation (2 00,000 iu/week) for 04 -06 weeks or placebo. these women will be checked for the diagnosis of gdm with 75 g ogtt at 24- 28 weeks of gestation. the outcome of the study will be the incidence of gdm based on the international association of diabetes and pregnancy study groups criteria.

gestational diabetes mellitus is a common condition among pregnant women with metabolic implications for both the mother and offspring. studies have suggested a potential role of vitamin d status in gdm risk, but evidence from randomized controlled trials is inadequate and inconclusive. a research has been planned to investigate the effect of vitamin d supplementation on gdm development among high risk pregnant women through a well-designed rct pregnant women at a risk to develop gdm with low vitamin d levels (\<30 ng/ml) at 07-11 weeks of gestation will be recruited and randomly assigned to receive either vitamin d3 supplementation (2 00,000 iu/week) for 04 -06 weeks or placebo. randomization will be achieved using a computer-generated random sequence or a randomization table. the allocation will be done in a 1:1 ratio, with equal numbers of participants assigned to the vitamin d and placebo groups. the primary outcome will be the incidence of gdm based on the international association of diabetes and pregnancy study groups criteria after 75 g ogtt. this study will contribute to the understanding of the relationship between vitamin d and gdm risk through a well-designed rct with integrated approaches. the findings may inform clinical practice and public health recommendations for vitamin d supplementation during pregnancy.

Eligibility criteria:
inclusion criteria: * pregnant women with 07-11 weeks of gestation * 21 - 40 years age range * pregnant women with high risk for gdm * history of gdm in their previous pregnancy, * one or more first-degree relative diagnosed with diabetes mellitus, * overweight-bmi \>25 kg/m2 or obese-bmi \>30 kg/m2 at their first antenatal visit * with a history of polycystic ovarian syndrome. * pregnant women with 07-11 weeks of gestation having normal response to 75g ogtt * low levels of vitamin d3 (\<30ng/ml) exclusion criteria: * women already diagnosed with diabetes mellitus * any other systemic disease. * high risk pregnant women diagnosed with diabetes on the basis of 75g ogtt * high risk pregnant women with normal vitamin d3 levels (\>30ng/ml).

Keywords: gestational diabetes mellitus pregnancy high risk women vitamin d supplementation
salvage hypofractionated accelerated versus standard radiotherapy for biochemical failure after prostatectomy

Conditions: Prostate Cancer; Biochemical Recurrence; Radiation; Hypofractionation; Dose Escalation; Survival; Radiation Toxicity; Quality of Life

Summary: patients with a biochemical recurrence after radical prostatectomy for moderate- or high- risk prostate cancer are randomly assigned to hypofractionated, accelerated high dose radiation therapy group (65 gy, 26 fractions) and a control group of standard treatment group (66 gy, 33 fractions). the criteria for stratification at randomization include 1) risk groups, 2) androgen deprivation therapy, and 3) psa before salvage radiation therapy, which affect biochemical recurrence. it is expected that hypofractionated, accelerated high dose radiation therapy will have a superiority in terms of biochemical control to conventional radiation therapy, and the present study would like to confirm this. in addition, we aimed to evaluate and compare the toxicity and quality of life index of two radiation therapy regimens.


Eligibility criteria:
inclusion criteria: * pathologically confirmed intermediate- or high-risk prostate cancer * biochemical recurrence after radical prostatectomy (definition: serial elevation of psa over 0.2 ng/ml and \<=1.0 ng/ml) * ecog performance status 0-1 * appropriate values of blood tests within 6 months after enrollment absolute neutrophil count (anc) ≥ 1500 cells/mm3 platelets ≥ 50,000 cells/mm3 hemoglobin ≥ 8.0 g/dl * appropriate values of kidney function within 6 months after enrollment creatinine \< 2.0 ng/dl * appropriate values of liver function within 6 months after enrollment total bilirubin \< 1.5 x maximum normal value alanine aminotransferase or aspartate aminotransferase \< 2.5 x maximum normal value exclusion criteria: * clinically gross recurrent tumor * presence of distant metastasis * presence of pelvic ln metastasis * history of pelvic irradiation * history of cryotherapy or brachytherapy for prostate cancer * double primary cancer other than skin/thyroid cancer * combined serious morbidity
biomarker study for heart failure in children with single ventricle physiology

Conditions: Tricuspid Atresia; Hypoplastic Left Heart Syndrome; Unbalanced AV Canal

Summary: the purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.

we will investigate whether levels of blood proteins in children with well-functioning hearts with one ("single") ventricle are similar to levels of these blood proteins in children with two ventricles. for children with hearts with a single ventricle, we will examine blood proteins at various levels of heart function. to assess blood protein levels, we will collect small (6 ml) samples of blood. heart function will be determined by existing clinical scoring systems. enrolled patients will receive an echocardiogram, which is a dynamic ultrasound picture of the beating heart.

Eligibility criteria:
inclusion criteria: * children with a structurally normal heart and a patent ductus arteriosus. * children with single ventricle physiology. exclusion criteria: * children must not have chromosomal abnormalities. small deletions, such as that which produces digeorge syndrome, are permissible. * children with acute intercurrent non-cardiac inflammatory illness (such as post-operative wound infection) are ineligible, as such conditions may cause elevated blood levels of the proteins under study.

Keywords: single ventricle congenital heart disease children fontan tricuspid atresia hypoplastic left heart syndrome heart failure biomarkers single ventricle physiology such as: unbalanced av canal interested in patients both before and after fontan surgery
health evaluation in african americans using ras therapy

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to determine if telmisartan, an fda approved blood pressure medication, may also have beneficial effects on alzheimer's disease prevention in african americans, who are at high risk for alzheimer's disease.

this study will assess if telmisartan, an fda approved blood pressure medication, may also have beneficial effects on alzheimer's disease (ad) prevention in african americans, who are at high risk for alzheimer's disease. blood pressure medications known as angiotensin-receptor blockers have been associated with reduced risk of alzheimer's in caucasians because they act on the renin-angiotensin system (ras), a key regulator of blood pressure in the body and the brain. the drugs appear to slow the progression of the disease by affecting flow of blood and the amount of plaque in the brain, but these benefits have not been tested in african americans. the investigator will evaluate if telmisartan is able to influence the renin-angiotensin system in the brain and produce favorable effects on brain blood flow and enzymes that cause the brain plaques in alzheimer's disease.the investigator will assess the mechanism by which telmisartan modifies the brain renin angiotensin system, cerebrospinal fluid amyloid-β, cerebral blood flow (cbf) and inflammatory markers in hypertensive african americans.

Eligibility criteria:
inclusion criteria: * mean resting systolic blood pressure ≥ 110 mmhg and ≤ 170 mmhg * family history of alzheimer's disease * african american exclusion criteria: * currently in another investigational drug study * potassium \>5.0 meq/dl at baseline * creatinine \>1.99 mg/dl at baseline * history of stroke or transient ischemic attack (tia) * dementia * current use of a ras acting medication * contraindication for lumbar puncture or magnetic resonance imaging * heart failure * diabetes types i and ii * pregnant or nursing women

Keywords: hypertension prevention family history inflammation blood brain barrier amyloid
effect of losartan on retinal endothelial function in patients with essential hypertension

Conditions: Hypertension

Summary: essential hypertension is commonly associated with impaired endothelial function. the retinal vasculature is morphologically and functionally related to the cerebral vessels because of the common origin from the internal carotid artery. a recent study in hypertensive patients demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive patients and that it can be restored by treatment with an at1-receptor antagonist. it is not clear whether this effect is due to blood pressure lowering or whether this is a blood pressure independent effect. the present randomized, double blind study with a cross over design addresses this issue by comparing the effects of losartan and metoprolol on retinal endothelial function in patients with essential hypertension.


Eligibility criteria:
inclusion criteria: * male and female patients aged 18-65 years with essential hypertension exclusion criteria: * secondary forms of hypertension * advanced damage of vital organs (grade iii and iv retinopathy) * history of serious hypersensitivity reaction to at1-receptor blockers * actual or anamnestic alcohol- or drug abuse. * smokers or ex-smokers \< 1 year. * patients with diabetes mellitus (oral medication or insulin). * patients with arterial fibrillation or av-block (ii° or more). * patients with anamnestic myocardial infarction. * patients with instable angina pectoris including ecg-aberrations or cardiac insufficiency nyha iii or iv. * history of malignancy (unless a documented disease-free period exceeding 10 years is present) with teh exception of basal cell carcinoma of the skin * history of allograft transplantation * therapy with not approved concomitant medication, or participation in a clinical study within 4 weeks preceding treatment start. * disease which interfere with the pharmacodynamics and pharmacokinetics of the study drug. * liver-or kidney disease with sgot, gpt, g-gt, ap, bilirubin and creatinin or above 200% of standard. * patients, who are not sufficiently compliant, or patients, who are not capable or willing to appear for controlling vistas. * presumed risk of transmission of hiv or hepatitis via blood from the participant

Keywords: endothelium, hypertension, retina, at1
a study of the effect of real-time pressure controllers on subjective and objective symptoms of peripheral neuropathy induced by albumin paclitaxel

Conditions: Real Time Pressure Controller; Breast Cancer; Albumin Paclitaxel; Peripheral Neuropathy

Summary: the purpose of the real-time pressure controller proposed in this experiment is to overcome the deficiencies of the existing technology and provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, with the pressure decreasing in a sequential manner from the distal end (toes/fingers) to the proximal end (wrists, limbs). the application of this device is of great clinical significance to reduce the peripheral neurotoxicity of paclitaxel and to improve patients' drug compliance. the application of cold compresses or gloves or socks with certain wrapping force is not suitable for the chinese population, and the acceptance degree of chinese patients is poor, and the pressure gloves lack individual specificity, and the precise control of pressure for real-time regulation cannot be realized, and the clinical effect is relatively poor. the purpose of this utility model device is to overcome the deficiencies of the existing technology, to provide a pressure filling device for the prevention of chemotherapy-induced peripheral neuropathy that can accurately control the pressure, and the pressure decreases in a sequential manner from the distal end (toes/fingers) to the proximal end (wrist, limb). after applying for the patent, it will be transformed into the market, which has a vast space of medical benefits and market benefits. paclitaxel is the cornerstone drug in breast cancer chemotherapy, and the neuropathy it causes is often a key factor leading to drug reduction or discontinuation, so opening up the prevention of peripheral neuropathy caused by paclitaxel is of great clinical use.


Eligibility criteria:
inclusion criteria: 1. voluntarily signed written informed consent; 2. age ≥18 years and ≤75 years at enrollment, male or female patients; 3. eastern cooperative oncology group (ecog) physical status score of 0 or 1; 4. suitable for albumin-paclitaxel antitumor therapy; 5. cardiopulmonary, hepatic, renal, and coagulation functions are basically normal. exclusion criteria: 1. patients with prior chemotherapy; 2. patients with a prior diagnosis of peripheral neuropathy; 3. patients with a prior diagnosis of associated comorbidities (e.g., diabetes mellitus).
can hospital acquired pneumonia be prevented in patients who gurgle?

Conditions: Hospital Acquired Pneumonia in Gurgling Patients

Summary: hospital inpatients who have gurgling sounds heard during speech or breathing have been observed to have a higher risk of hospital acquired pneumonia. patients who gurgle and who consent to participation will be randomized to receive routine clinical management or management to include measures employed to reduce risks of aspiration, namely, 1. head of bed up (30 degrees or higher), 2. swallowing evaluation by speech therapist (and feeding predicated on formal evaluation), 3. prompting managing physicians to reduce sedating medications to minimal effective dose.


Eligibility criteria:
inclusion criteria: * gurglers who consent to participate exclusion criteria: * non-gurglers * patients presenting with pneumonia prior to identification with gurgling * patients receiving comfort-care-only
reducing pain and disability after breast cancer surgery

Conditions: Breast Cancer; Chronic Pain

Summary: the purpose of this study is to determine if the combination of thoracic paravertebral block and multimodal analgesia will decrease chronic pain and arm morbidity in patients undergoing breast cancer surgery with lymph node dissection as compared to patients receiving local anesthesia with multimodal analgesia.

sixty percent of breast cancer patients undergo some form of breast surgery in the treatment of the early stages of the disease. the recovery from surgery can be associated with severe disabling pain persisting beyond 12 months after surgery. research in pain has shown that early intervention of acute pain can prevent long term chronic pain. at the ottawa hospital, patients receive either paravertebral blocks or wound infiltration with local anesthetic for postoperative pain management. we would like to compare these two methods of pain control to determine an analgesic technique that will reduce acute and chronic pain, and maximally improve long-term functional recovery and patient's quality of life.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of breast cancer * scheduled for elective modified radical mastectomy, simple mastectomy with slnb, breast conserving surgery (ie lumpectomy, segmental mastectomy) with alnd or alnd alone (after positive slnb) exclusion criteria: * american society of anesthesiologist (asa) class 4 or 5 * patients with contraindications to tpvb * allergy to study medications * chronic opioid use defined as daily consumption of greater than 20 mg of oral morphine or equivalent for \>7days * renal insufficiency defined as a creatinine clearance \<40ml/min as calculated using the cockroft-gault formula * preoperative radiation therapy * inability to achieve normal shoulder range of motion as defined as \<100o of shoulder abduction or flexion

Keywords: anesthesia local anesthetics analgesia quality of life paravertebral blocks arm morbidity
pilonidal sinus-turkey

Conditions: Pilonidal Sinus Treatment

Summary: in this research, main purpose is to determine the recurrence prevalence. destination of the cohort study in which retroprospective data are prospectively reviewed, which aims to identify pilonidal disease subtypes for which various treatment options are indicated, identify various interventions, associate patients with the clinical stage, determine which results are meaningful to patients and which interventions they prefer and provide further research investigation recommendations. . primary outcome; to determine the postoperative recurrence rates according to the type of surgical intervention. the secondary outcome is; to compare the overall patient satisfaction between different operative techniques and to obtain the ratio of different techniques applied for pilonidal sinus treatment in turkey.

in this study, the patient must be over 18 years of age for potential patient data for elective surgical treatment of pilonidal disease. the treatment techniques which considered eligible for the study should be determined by the surgical team and the patient information forms should be filled in at the hospital where the treatment was applied. before collecting any patient data, the lead investigator or authorized research team member must be verified as suitable for the study. information should be processed on the case report form (crf) specifically designed for surgical intervention, and the surgeon's current practice should be in the information forms. collected participant data will be recorded in the relevant crfs and patient questionnaires. you should call to ask about the postoperative 1st day, 7th day, 6th month and 12th month status of the patients who provide the inclusion criteria and were operated during period -the defined by research protocol- . as a result; since all patients who were operated between january 2019 and january 2020 and were included in the study completed their 12th month, the status of these patients in the specified dates will be questioned retrospectively and a prospective follow-up will not be performed. later, the data will be transferred and entered into redcap, a remote web-based data collection system. in crf, the operations that the patient has had for pilonidal sinus treatment, the presence of postoperative recurrence, the time to return to normal activities, pain level and general treatment satisfaction are questioned.

Eligibility criteria:
inclusion criteria: - symptomatic patient with the pilonidal sinus who is decided the treatment methods by the clinician. exclusion criteria: * patients under 18 years of age asymptomatic (stage i), acute abscess (stage ii), pregnant patients, presence of systemic disease such as dm, uc, hidradenitis suppurativa, patients with session hypersensitivity and the patients who are not authorized to give consent.
an open-label study of vedolizumab (mln0002) in participants with ulcerative colitis and crohn's disease

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: the purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (mln0002) administration.

the drug being tested in this study is called vedolizumab. vedolizumab is being tested to treat people who have ulcerative colitis or crohn's disease. this study will determine the safety profile of long-term vedolizumab treatment. the study enrolled 2243 patients. participants who received either placebo or vedolizumab 300 mg iv infusion every 4 or 8 weeks in previous vedolizumab studies received: • vedolizumab 300 mg all participants received vedolizumab intravenous infusion every 4 weeks for approximately up to 510 weeks. this multicenter trial is being conducted worldwide. the overall time to participate in this study was up to october 2017 until vedolizumab was available in the country in which the participant resided, or until participant withdrawal, whichever came first. participants made multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab and were being followed up for 2-years during which a safety questionnaire was administered by telephone for follow-up assessments.

Eligibility criteria:
inclusion criteria: 1. previous treatment in study c13004 (nct00619489), study c13006 (nct00783718), study c13007 (nct00783692), or study c13011 (nct01224171) that, in the opinion of the investigator, was well tolerated or b. moderate to severe crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (mln0002) 2. may be receiving a therapeutic dose of conventional therapies for crohn's disease or ulcerative colitis as defined by the protocol exclusion criteria: 1. development of any new, unstable, or uncontrolled disease

Keywords: drug therapy
celebrex low dose asa study examining the incidence of gastroduodenal ulcers in a healthy population

Conditions: Peptic Ulcers

Summary: the aim of the current study is to replicate the coxa-0508-258 study in a multicenter, us setting, using a lower dose of asa. it is expected that this study will not only confirm the results of the 258 study but show that the incidence of ugi ulcers on celecoxib is significantly less than on traditional nsaids and the incidence of ugi ulcers on celecoxib increases with the addition of asa, but still is lower than traditional nsaids plus/minus asa. this 7-day study is designed to compare the incidence of gastroduodenal ulcers associated with celecoxib 200 mg qd and low dose aspirin 81 mg qd and with naproxen 500 mg bid plus low dose aspirin 81 mg qd in healthy adults(50-75 years of age).


Eligibility criteria:
inclusion criteria: * a healthy adult between 50 and 75 years of age inclusive: of normal clinical laboratory test results during the screening visit or, if abnormal, are not clinically significant in the investigator's opinion. exclusion criteria: * a gastric, pyloric channel or duodenal ulcer (defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than 5 erosions in the stomach or duodenum ( the ugi endoscopic score greater or less) on the baseline ugi endoscopy