Kornimate/medical-research-clean huggingface dataset:
a research study to evaluate the renal (kidney) protective effects of losartan in patients with non-insulin dependent diabetes (0954-147)(completed)

Conditions: Type 2 Diabetes; Nephropathy

Summary: evaluate the effect of losartan in reducing kidney disease in patients with non-insulin dependent diabetes and nephropathy (kidney damage that usually accompanies late stage diabetes mellitus).


Eligibility criteria:
inclusion criteria: * diabetes diagnosed after the age of 30 * insulin not required within 6 months of first being diagnosed with non-insulin dependent diabetes mellitus * no history of diabetic ketoacidosis * patients may be currently treated with diet, oral hypoglycemics or insulin * patients must have proteinuria defined as: urine protein \>1+ on dipstick at the initial screening visit * patients with hypertension (high blood pressure) must have a sitting blood pressure \>200/110 mm hg at visit 1 exclusion criteria: * patients with insulin-dependent diabetes mellitus (juvenile onset) * patients treated with an ace inhibitor or angiotensin ii antagonist (aiia) for \>5 years * patients treated with ace inhibitor or aiia therapy for 5 years or less may enter the study provided therapy is discontinued during the 6 week screening period prior to randomization * history of myocardial infarction (mi) (heart attack) or coronary artery bypass graft (cabg) surgery within the past 1 month * history of cerebral vascular accident (cva) (stroke) or percutaneous transluminal coronary angioplasty (ptca) within the past 6 months * history of transient ischemic attacks (tia) within the past year. patients with unstable angina are excluded until stabilized * heart failure requiring ace inhibitor therapy * steroids (oral or parenteral) or immunosuppressives are not permitted. debilitating psychological illness * evidence of significant hepatic (liver) dysfunction: history of allergy to losartan * known positive test for hiv or patients known to be hepatitis b or c antigen carriers * pregnant or nursing women * females of childbearing age must either be surgically sterilized or, if sexually active, using an effective form of contraception and may enter only if an exclusionary pregnancy test is done within approximately 72 hours prior to randomization * pregnancy tests will be done every 3 months during the study and at the time of discontinuation
effect of two different methods on pain and anxiety

Conditions: Pain

Summary: the aim of this study is to determine the effect of virtual reality glasses and ball squeezing method used during peripheral intravenous catheter placement on pain and anxiety.the hypotheses of this research are that virtual reality glasses and a stress ball reduces pain and anxiety.

this study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. the research will be carried out in the general surgery clinic of necmettin erbakan university meram medical faculty hospital. patients will be randomly assigned to three groups: ball squeezing (37), virtual reality glasses (37) and control group (37). for virtual reality glasses group: the video containing the nature walk will be watched by virtual reality. 3 minutes after the individual starts watching the video, the iv catheter insertion attempt will be performed while continuing to watch the video. for ball squeezing group: patients will be given a ball and instructed to tighten and loosen with their free hand during intravenöz catheter placement. the intravenöz catheter insertion attempt will be made while the patient continues to squeeze the ball. for control group: no application will be made during intravenous catheter placement in the control group.the primary outcome of this study was to determine the patients' pain scores during the peripheral venous cannula insertion process.the secondary outcomes of the study were to determine the patients' anxiety levels.

Eligibility criteria:
inclusion criteria: * admission to the general surgery clinic. * no verbal, perceptual and visual communication problems, * being between 18 - 65 years old, * being literate, * volunteer to participate in the research, * not using drugs that will create a chronic analgesic effect, * absence of chronic or acute pain, * no intervention in the last month in the vein where an iv catheter was placed. * the absence of scar tissue and infection in the areas to be used for iv catheter placement, * it was determined as not having a disease (such as neuropathy) that would cause problems in feeling pain. exclusion criteria: * the individual's desire to leave the study, * inability to perform the ball squeezing motion, * feeling unwell during iv catheter placement (such as dizziness, palpitations), * during use of vr, the patient experiences symptoms such as nausea and dizziness, * using sedatives or alcohol, termination criteria • failure of piv catheter placement,

Keywords: peripheral intravenous catheter insertion pain anxiety
prophylactic sodium supplementation for children hospitalized with pneumonia

Conditions: Childhood Pneumonia

Summary: the goal of this clinical trial is to study the impact of sodium supplementation on hospital outcomes of children with pneumonia. it aims to answer: * does sodium supplementation lower the length of hospital stay in children with pneumonia? * does potassium supplementation lower the length of hospital stay in children with pneumonia? researchers will compare the intervention arm to a placebo arm to see if the intervention lowers the length of hospital stay. participants will: • take one sachet of oral rehydration solution (ors) every day for 3 days.

the study is a randomized clinical trial that will be conducted on hospitalized children with pneumonia after considering exclusion criteria. the enrolled children will be randomly divided into two groups. the intervention group will receive oral rehydration solution (ors), and the placebo group will receive a placebo. children will receive either the ors or the placebo daily for 3 days. all children will be followed until discharge from the hospital, and their clinical outcomes will be assessed.

Eligibility criteria:
inclusion criteria: * infants and children aged between 1 month and 5 years. * patients diagnosed with pneumonia according to world health organization (who) criteria. exclusion criteria: * children with other comorbidities. * those whose parents will show disapproval for the participation of the study. * children on medications that affect sodium and potassium levels.
lccc1931:post-treatment intervention in women with breast cancer (70y/o+)

Conditions: Breast Cancer

Summary: this study recruits woman over the age of 70 who have completed primary treatment for early breast cancer in the last 2 months. a survey called the geriatric assessment will be used to identify symptoms and issues participants experience.this information will be given to the patient's medical oncology team, and used to make referrals to specialists. this study is designed to determine if these assessments and timely interventions can be completed during clinic visits, and determine if these participants comply with recommendations.

1. primary objective estimate the percent of patients with at least one deficit who agree to at least one referral. "interest" in the intervention will be determined by this metric. this agreement will be determined within the 1-2 weeks of consenting to the study through interactions between patients and the study team. this study will recruit 100 participants in 2 years. these participants will complete the geriatric assessment and be given recommendations based on results. the study team will follow the medical record to determine if the participants complied with the recommendations

Eligibility criteria:
inclusion criteria: * women aged 70 or older * within 6 months of complete primary treatment (surgery, chemotherapy, targeted therapy, or radiation) for reach breast cancer (stage i-iii) * able to read english * willing and capable of providing informed consent exclusion criteria: -has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rendering of informed consent.
xeloda or uft (tegafur-uracil) with folinic acid in advanced or metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the scope of the trial is to determine the preference of patients, after randomization and cross-over, for one of the two treatments. another objective of the trial is to assess and compare the safety of each treatment.

further study details as provided by centre oscar lambret.

Eligibility criteria:
inclusion criteria: * locally advanced or metastatic colo-rectal cancer * age \> or = 18 years old * ps-who \< or = 2 * polynuclear neutrophil leukocytes \> or = 1500/mm3, platelets \> or = 100000/mm3 * total bilirubin \< or = 3 uln, asat-alat \< or = 2.5 uln * effective contraception * written informed consent signed exclusion criteria: * concomitant radiotherapy * contraindication to fluoropyrimidines * treatment with sorivudine and its chemical analogs such as brivudine * severe hepatic insufficiency * severe renal insufficiency * pregnant or lactating woman * hypersensitivity to capecitabine, 5fu, tegafur or one of its excipients

Keywords: colo-rectal cancer advanced metastatic locally advanced or metastatic colo-rectal cancer
recipe for heart health

Conditions: Atherosclerotic Cardiovascular Disease

Summary: the overall objectives of this project are to compare clinical parameters in moderate risk atherosclerotic cardiovascular disease (ascvd) patients following a whole food plant based (wfpb) diet containing a high (4 tb) compared to a low (\<1 tsp) amount of raw extra virgin olive oil.

up to sixty-eight primary prevention outpatient adults with intermediate to high ascvd risk factors will be randomized in a crossover fashion to follow a wfpb diet without animal products that is either high (4 tablespoons) or low (\< \~1 teaspoon) in raw extra virgin olive oil. after confirming eligibility and patients provide consent, the research team will randomize the participant at the baseline visit. the baseline visit and run-in visit 1 will follow as described below. with the intent of recruiting cohorts of ten, a group of participants will subsequently begin the first whole food plant based culinary diet intervention for four weeks, followed by a one-week (+ 3 days) washout period before switching to the opposite oil diet for an additional four weeks. during each of the 4-week interventions, participants will attend weekly cooking sessions that align with the dietary intervention with a registered dietitian. patients will be asked to maintain levels of physical activity through the duration of the study. data will be collected at the patient's cardiology visits before and after each diet intervention for a total of four in-person visits excluding the screening visit.

Eligibility criteria:
inclusion criteria: -adult patients with borderline to high risk for ascvd exclusion criteria: -adult patients with known cardiovascular disease
measurement of the folate receptor in blood

Conditions: Healthy

Summary: the folate receptor (fr) is a cell marker that is over expressed on the cell surface of certain cancers, this occurs most frequently in ovarian cancers. some normal tissues also express the fr, however in these normal tissues the fr is usually located on the tissue surface that is inaccessible to circulating drugs. as such, drugs which target the fr may potentially be used to achieve anti-tumour efficacy whilst reducing toxicity to normal tissues. therefore the ability to measure fr levels from different cancer types may help to select patients who are most likely to benefit from treatment with fr targeted therapies. one such drug bgc 945 is currently being tested in preclinical study at the institute of cancer research

a method has been developed in the laboratory which has been able to measure fr obtained from cancer cells in culture that has been added into blood. we would like to study if this method can measure fr in plasma and serum obtained from patients with ovarian cancer. we would also like to analyse plasma and serum samples obtained from healthy volunteers to determine if they have any appreciable levels of fr, which can then be compared to the measurements obtained from cancer patients.

Eligibility criteria:
inclusion criteria: * patients with stage iii/iv ovarian cancer * healthy volunteers who are staff at the icr and rmh exclusion criteria: * patients or healthy volunteers who are unable to give informed consent * pregnancy

Keywords: folate receptor blood samples ovarian cancer development of measure of folate receptor in blood samples possible selection of patients for treatment with fr targeted agents
effect of mouthwash containing camellia sinensis extracts on oral malodor

Conditions: Gingivitis; Halitosis

Summary: the purpose of this study is to determine effect of mouthwash containing camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.

at baseline, level of volatile sulfur compounds (vsc) in mouth air, plaque index and papillary bleeding index will be recorded. gingivitis subjects will be asked to rinse with camellia sinensis mouthwash or placebo mouthwash. vsc level will be measured at 30 minutes and 3 hours post-rinsing. for the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. all parameter will be recorded again at day 28.

Eligibility criteria:
inclusion criteria: * at least 20 teeth * clinical diagnosis as plaque induced gingivitis * having over 80 ppb of volatile sulfur compounds in mouth air exclusion criteria: * smoker * denture wearer * having systemic diseases or oral pathology * taking antibiotics 1 month prior to study

Keywords: camellia sinensis volatile sulfur compounds
virtual reality in the treatment of pelvic floor dysfunction in women with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of the current randomized clinical trial was to compare the effectiveness of virtual reality versus posterior tibial nerve stimulation on the improvement of pelvic floor dysfunctions in women with multiple sclerosis.

* design: randomized clinical trial. objective: to determine the effects of virtual reality versus posterior tibial nerve stimulation and muscle activation exercises on the improvement of pelvic floor dysfunctions in women with multiple sclerosis. * methods and measures: forty five women will be randomly assigned to one of three groups. * intervention: for 8-week, the group 1 will undergo treatment with virtual reality (2/week), the group 2 will receive posterior tibial nerve stimulation (2/week) and the group 3 will receive muscle activation exercises of the pelvic floor. * main outcome measures: assessment of pelvic floor muscles function (strength and muscle tone), urodynamic studies, and validated questionnaires data will be collected at baseline, and 1 week after the last therapy application. mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * presence of pelvic floor dysfunction * acceptance participation * not undergoing another physical therapy treatment exclusion criteria: * non-acceptance of participation * mental illness * interruption of adherence to protocolized treatment sessions * indication of surgical treatment in the pelvic floor

Keywords: virtual reality multiple sclerosis pelvic floor randomized controlled trial
comparison of short-term application of dialysis catheter with tunnel-cuffed catheter versus non-ccuffed catheter: a multicenter prospective cohort study

Conditions: Clarify the Difference of Short-term Infection Rate Between Diffrent Catheter

Summary: through a multi-center, prospective cohort study, hemodialysis patients with right internal jugular vein catheterization were collected and divided into tunnel-cuffed catheter group and non-cuffed catheter group according to the types of catheterization. the incidence of catheter infection, thrombosis and other complications between the two groups were compared.to clarify the difference of short-term infection rate between tunnel-cuffed catheter and non-cuffed catheter.


Eligibility criteria:
inclusion criteria: * ① age ≥18 years; ② uremia, clinical evaluation needs to start hemodialysis immediately, and the right internal jugular vein catheterization is the vascular access for the subjects. ③ subjects who underwent right internal jugular vein catheterization on regular hemodialysis due to poor internal fistula function and the recovery time of internal fistula was ≥4 weeks; ④ patients with aki who need renal replacement therapy and underwent catheterization in the right internal jugular vein, and the renal replacement time is ≥4 weeks. exclusion criteria: * ① subjects with previous history of central venous thrombosis, stenosis, infection, etc. ② the subjects were not dialyzed three times a week; ③ other subjects with central venous catheterization, including left internal jugular vein, femoral vein and subclavian vein; ④ those who take immunosuppression for a long time.
the study of atherosclerosis with ramipril and rosiglitazone

Conditions: Atherosclerosis; Impaired Glucose Tolerance; Isolated Impaired Fasting Glucose; Cardiovascular Disease

Summary: the purpose of this study is to determine if ramipril and/or rosiglitazone retard the progression of atherosclerosis as evaluated by serial carotid intermedial thickness measurements.

starr is a multi-centre, international, randomized controlled clinical trial with a 2x2 factorial design, that will evaluate the effects of ramipril and of rosiglitazone on atherosclerosis progression, as determined by b-mode carotid ultrasound (us). it is designed as a substudy of dream (diabetes reduction assessment with ramipril and rosiglitazone medications) trial. the study is designed to enroll 1,200 study participants and follow is proposed for an average of 3.75 years. significance of the proposed research: with regards to ramipril this study will provide important mechanistic data regarding potential benefits of ace inhibitor therapy on atherosclerosis and by inference in reducing cv risk in a lower risk younger population than studied in previous trials. in this population a clinical outcome trial focusing primarily on cv events would be difficult to conduct due to the expected fairly low event rate. if the study on atherosclerosis is positive, this may provide a rational for therapy in this subset of patients without overt cvd or diabetes, but with impaired glucose tolerance or impaired fasting glucose.

Eligibility criteria:
inclusion criteria: * impaired glucose tolerance (fpg \< 7 mmol/l or 126 mg/dl \& 2hr pg between 7.8-11.0 mmol/l \[140-199 mg/dl\] after a 75 g ogtt * impaired glucose tolerance (fpg≥ 6.1 mmol/l \[110 mg/dl\]) and no diabetes (i.e. a fpg \< 7.0 mmol/l \[126 mg/dl\]) * a technically adequate baseline carotid ultrasound examination exclusion criteria: * current use of an ace-inhibitor (ace-i) or thiazolidinedione (tzd) * known hypersensitivity to ace-i * prior use of anti-diabetic medications 9with the exception of during pregnancy) * use of systemic glucocorticoids or niacin * congestive heart failure or ef \< 40% * existing cardiovascular disease (previous mi, stroke, angina, uncontrolled hypertension) * diabetes * renal or hepatic disease * major illness * use of another experimental drug * pregnant or unwilling to use reliable contraception * major psychiatric disorder * diseases that affect glucose tolerance * unwillingness to be randomized or sign informed consent * known uncontrolled substance abuse * inability to communicate with research staff

Keywords: atherosclerosis carotid artery ramipril rosiglitazone impaired glucose tolerance impaired fasting glucose diabetes prevention
safety and efficacy study of rebamipide 2% ophthalmic suspension in subjects with dry eye - effects on central cornea

Conditions: Keratoconjunctivitis Sicca; Dry Eye

Summary: the purpose of this study is to evaluate the safety and efficacy of 2% rebamipide compared to placebo in clearing of fluorescein staining of the central cornea in subjects with dry eye disease.


Eligibility criteria:
inclusion criteria: * age 18 years and older * diagnosis of dry eye as defined by the protocol * central corneal staining exclusion criteria: * ongoing ocular disease that may interfere with study parameters * inability to stop using topical ophthalmic medications throughout the duration of the study * inability to stop the use of contact lenses for the duration of the study
evaluate the utility of serum hepcidin levels to predict response to oral or iv iron

Conditions: Iron Deficiency Anemia (IDA)

Summary: the main objective of this study is to compare the safety, effect on quality of life, and resource utilization of injectafer vs. intravenous (iv) iron standard of care (soc) for the treatment of iron deficiency anemia (ida) in an infusion center setting. the study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to iv iron therapy.

the main objective of this study is to compare the safety, effect on quality of life, and resource utilization of injectafer vs. intravenous (iv) iron standard of care (soc) for the treatment of iron deficiency anemia (ida) in an infusion center setting. the study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to iv iron therapy.

Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 18 years of age and able to give informed consent. * iron deficiency is the primary etiology of anemia. * if using erythropoiesis stimulating agent (esa), the subject must be using a dose consistent with package insert that has been stable for at least 30 days. * doses of potential myelosuppressive medications have been stable for at least 30 days. * females at risk of pregnancy must agree to use an acceptable form of birth control and have a negative serum or urine pregnancy test on the first day of dosing. exclusion criteria: * hypersensitivity reaction to any component of injectafer. * requires dialysis for treatment of chronic kidney disease (ckd). * no evidence of iron deficiency. * during the 10 day period prior to screening has been treated with intravenous iron. * during the 30 day period prior to screening has been treated with a red red blood cell transfusion. * any non-viral infection. * known positive hepatitis with evidence of active disease. * received an investigational drug within 30 days of screening. * alcohol or drug abuse within the past 6 months. * hemochromatosis or other iron storage disorders. * estimated life expectancy of less than 6 months, or for cancer patients, an eastern cooperative oncology group (ecog) performance status greater than 1. * pregnant or actively trying to become pregnant (a definitive negative result on a serum or urine pregnancy test performed on the first day of dosing will be required for study enrollment by any women of childbearing potential). * any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.