Kornimate/medical-research-clean huggingface dataset:
effect of holistic management on the patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: two hundreds patients with t2dm from the outpatient clinic of the first affiliated hospital of chongqing medical university will be enrolled in this study. participating subjects will be randomly assigned into one of the 2 groups: group a (n=100) will be placed on the short-term intensive education program alone while group b (n=100) will be placed on the short-term intensive education as well as a holistic management for 6 months. diabetes education: the patients of each group will undergo designated education programs in 4 subgroups. group a and b will be given the same education classes once a week in the first month (total 4 times), 5 hours per class. the education classes will be taught by a dedicated team of diabetes specialist doctors and nurses, with the contents including a basic understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose monitoring. at the conclusion of the education classes, the patients in group b then will undergo a weekly telephone interview with specialist nurses for 6 months to help patients resolve self-management problems while patients in group a will not. the specialist nurses will talk individually with the patients in group b for 10-15 min per week. the nurses will ask the patients about their results of self-blood glucose monitoring, help them find the reasons of poor blood glucose control as well as answer the patient's questions. clinical examination: all subjects will complete audit of diabetes dependent quality of life (addqol) before education classes commence (baseline), at 3 months and 6 months (endpoint) after education classes to evaluate their quality of life. all patients will be examined for height, weight, blood pressure, fpg, ppg and hba1c at baseline, 3 months after education classes and endpoint. a diabetes specialist nurse will measure the height, weight and blood pressure, and assist the subjects to fill the questionnaire. fpg and ppg will be determined by the hexokinase method, while hba1c by high performance liquid chromatography.


Eligibility criteria:
inclusion criteria: * patients with t2dm for more than 1 year, * age from 18 to 75 years old, * have fasting plasma glucose (fpg) ≥ 7.2mmol/l or 2 hours postprandial plasma glucose (2hppg) ≥ 10.0mmol/l, * glycosylated hemoglobin (hba1c) ≥ 7.0%, * have the ability to self-care. exclusion criteria: * patients with severe liver or kidney dysfunction, severe heart failure, cognitive dysfunction or pregnancy will be excluded.

Keywords: type 2 diabetes holistic management
pharmacokinetics, pharmacodynamics and cervicovaginal lavage of combined oral contraceptives and raltegravir

Conditions: HIV

Summary: the purpose of this trial is to learn about potential interactions between raltegravir and a birth control pill in hiv+ women. the investigators plan to enroll hiv+ women who are on steady state raltegravir containing highly active antiretroviral therapy (haart), ages 20-40, inclusive, who report regular monthly menses. the investigators will investigate drug interactions of raltegravir, ethinyl estradiol (ee) and levonorgestrel (lng). all women will be receiving raltegravir as part of their regular medical care. women will be enrolled in the study for approximately 8 months.


Eligibility criteria:
inclusion criteria: * women between 20-40 years of age with regular monthly menses * if over age 35 then must not use tobacco * negative pregnancy test * no known allergy to raltegravir * no known history of phenylketonuria * undetectable hiv viral load * no active liver disease as determined by medical history and normal ast and alt * no history of hepatic adenomas, carcinomas or benign liver tumors * ho history of thrombophlebitis of thromboembolic disease * no history of deep vein thrombosis * no history of cerebral vascular or coronary artery disease * no known or suspected carcinoma of the breast * no undiagnosed abnormal genital bleeding * not taking concomitant cyp 450 inducing medications such as anti-seizure medications * no use of oral contraceptives, depot-medroxyprogesterone acetate, contraceptive ring or patch within two months of screening * no cholestatic jaundice of pregnancy or jaundice with prior contraceptive pill use * has used raltegravir prior to screening * has no history of malignancy of the genital tract (e.g. cervical cancer, ovarian cancer, endometrial cancer) * must not have had an abnormal pap test defined without resolution in the last 18 months.

Keywords: contraception hiv pharmacokinetics pharmacodynamics
a prospective controlled study on treatment of giant cavernous hemangiomas of the liver

Conditions: Laparoscopic Hepatectomy; Radio-frequency Ablation; Giant Cavernous Hemangiomas; Liver

Summary: in the past, the investigators often treated giant cavernous hemangiomas of the liver by hepatectomy.recently rfa and laparoscopic hepatectomy are also available and could be applied to cure this disease.but we can't get a clear answer about their effectiveness and safety. hence the investigators conduct this study to explore the effectiveness and efficiency of the these two methods and compare their short to mid-term outcomes.


Eligibility criteria:
inclusion criteria: * giant cavernous hemangiomas with a diameter larger than or equal to 5 cm diagnosed by more than one imaging modalities * age between 18 years to 65 years * without gender restriction * plt account more than 50 e9 * without abnormal of liver function test * with substantial evidence of growing size than before * symptom associated cavernous hemangiomas * with a strong desire of the patients for the treatment exclusion criteria: * pregnant women * abnormal of liver function or coagulation dysfunction and/or concurrent with sever cardiac or pulmonary disorders * patient with a poor condition that can't bear the approach of either rfa or laparoscopic hepatectomy * tumor size more than 20cm

Keywords: laparoscopic hepatectomy radio-frequency ablation giant cavernous hemangiomas liver
arthroscopic treatment for femoral acetabular impingement syndrome with gluteus medius lesions.

Conditions: Femoral Acetabular Impingement

Summary: to evaluate the prognosis of femoral acetabular impingement syndrome (fais) patients with gluteus medius lesions after hip arthroscopy.

the data of fais patients with gluteus medius lesions were retrospectively extracted pre- and postoperatively after hip arthroscopy. the prognosis of the surgery was evaluated through mri images.

Eligibility criteria:
inclusion criteria * diagnosed fais * ineffective conservative treatment * available pre- and postoperative images exclusion criteria * revision arthroscopy * osteoarthritis * history of hip joint disease or surgery * sacroiliac joint disease * loss of follow-up
extension study to evaluate the long-term outcomes of subjects in study 20090

Conditions: Retinopathy of Prematurity (ROP)

Summary: this is a follow-up study to evaluate the long term outcome of babies treated in the firefleye study.


Eligibility criteria:
inclusion criteria: * subject was treated in study 20090 * age less than 13 months of chronological age * signed informed consent from parent(s)/legally authorized representative(s), which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol exclusion criteria: - subject has a condition preventing participation in the study, or performance of study procedures.
rifaximin predicts the complications of decompensated cirrhosis

Conditions: Cirrhosis

Summary: cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. it has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis. the aim of this study was to explore the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.

cirrhotic patients are predisposed to intestinal dysmotility, bacterial overgrowth, and increased intestinal permeability all leading to an increase in bacterial translocation and increased endotoxemia. cirrhotics with bacterial translocation and endotoxemia manifest hemodynamic derangement with lower systemic vascular resistance, higher cardiac output, and lower mean arterial pressure. moreover, endotoxins may increase portal pressure by increasing vascular resistance which may be promoted through the cytokine-stimulated intrahepatic release of endothelin and cyclo-oxygenase products. indeed, bacterial infections are common in cirrhotic patients and have approximately 30% mortality at one month and a further 30% mortality at 12 months as documented in a systematic review comprising almost 12 000 patients. it follows that altering gut flora to decrease endotoxin levels may lead to improved prognosis in cirrhosis. rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract. it has been suggested that oral prophylactic antibiotics or bowel decontamination might improve long-term outcomes in patients with cirrhosis, not only by reducing the risk of infections but also by reducing hepatic vein pressure gradient (hvpg). the aim of this study was to explore the suitable dose of rifaximin to alleviate endotoxemia and prevent the complications of advanced cirrhosis.

Eligibility criteria:
inclusion criteria: * decompensated cirrhosis * child-pugh b or c stage exclusion criteria: * severe complications of cirrhosis in the past one month. * renal dysfunction. * administration of antibiotics in the past two weeks. * malignant tumors. * hiv infection. * severe heart and lung disease * sensitivity to rifaximin * pregnancy and lactation woman * patients who have took part in other clinical trials in the past three months.

Keywords: rifaximin endotoxemia cirrhosis advanced cirrhosis
effects of an amino acid and chromium-picolinate containing drink on glucose metabolism on healthy subjects

Conditions: Diabetes

Summary: it has previously been shown in healthy overweight subjects, that table water including a defined amount of amino acids and chromium can decrease the postprandial glucose. in this study, the effect of this table water on glucose excursions after a test meal containing a defined amount of available carbohydrates, protein and fat will be studied in healthy subjects. the study will be conducted in a cross -over design, double blinded and placebo controlled including 20 participants. the primary endpoint of the study is the incremental area under the curve for plasma glucose (iaucgluc) within 180 minutes after ingestion of the meal.


Eligibility criteria:
inclusion criteria: * stable body weight (no changes above 3 kg during the last 2 months) * good general health * body mass index 19 - 30 kg/m2 (normal to overweight) * fasting blood glucose below 6.1 mmol/l exclusion criteria: * any medication that could influence the study. such as medication against diabetes, hypoglycemia, hypertension or hypercholesterolemia * psychiatric disease * alcohol or drug abuse * smokers or people consuming snus * acute infections * vegetarians/vegans * suffering from lactose or gluten intolerance * pregnancy or lactation * participation in another study at the same time * any other parameter that the pi will judge as inadequate
bleeding events after triple antithrombotic therapy initiation.

Conditions: Bleeding

Summary: the optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the gold standard. our study aims at studying bleeding events occurring until 6 months after the initiation of triple antithrombotic therapy.


Eligibility criteria:
inclusion criteria: * patients requiring triple antithrombotic therapy, including double antiplatelets agents and oral anticoagulation exclusion criteria: * history of bleeding * patients already under triple antithrombotic therapy * patients under vitamin k antagonists
end-organ pathology in childhood essential hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to determine the distribution of left ventricular hypertrophy and retinal vascular abnormalities in children and adolescents with essential hypertension; to evaluate potential risk factors and the time sequence for the development of these end-organ complications in this population.

background: elevated blood pressure has been established as an important risk factor for the development of cardiovascular disease morbidity and mortality. the major manifestations of end-organ pathology associated with hypertension include congestive heart failure, ischemic heart disease, stroke, and peripheral artery disease, including renal failure and retinopathy. as blood pressure has been studied in children, it has become evident that adult essential hypertension and its complications may have origins in adolescence and childhood. clinical observations have shown that some individuals with elevated blood pressure will develop one form of morbidity, while others develop a different form, and still others do not develop any complications. the reasons for this are unknown. few studies have been done which attempt to delineate risk factors for the development of the different end-organ pathologies in hypertensive individuals. two end-organ problems are particularly amenable to study in children. ultrasound examination of the heart allows the non-invasive study of left ventricular hypertrophy which is an important precursor to the development of congestive heart failure. retinal examination by fundal photograph and fluorescein angiography allows the examination of the effects of elevated blood pressure on the vessels of the eye. design narrative: the first phase of the study had a cross-sectional design. in this phase, echocardiography was used to measure left ventricular dimensions, mass, volume and function and fundoscopic examination and fluorescein angiography were used to determine retinal vascular abnormalities. data were collected on the independent variables of age, sex, race, obesity, level and duration of increased blood pressure, ambulatory variability of blood pressure, family history of hypertension, treatment with antihypertensive medication, sodium intake, smoking, alcohol use, fasting blood glucose, hemoglobin, basal plasma renin activity, plasma catecholamines, cardiovascular reactions to mental stress and to exercise. multiple regression analysis was used to determine which of the independent variables were independently associated with left ventricular mass, creatinine clearance, and retinal vascular abnormality. the second phase of the study was a longitudinal investigation of the development of left ventricular hypertrophy, changes in left ventricular function and retinal vascular disease, and the temporal relationship of these complications to the risk factors found in the first phase, using a cohort design. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
influence of pantoprazole on the bioavailability of mmf and ec-mps

Conditions: Transplantation; Immunosuppression; Drug Interaction

Summary: the objective of this pharmacokinetic study is to examine a possible drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid.

it is a randomized open-label 4-sequence 4-period pharmacokinetic cross-over study. the objective of the pharmacokinetic study is to examine a drug-drug interaction of pantoprazole on the bioavailability mycophenolic acid administered as either mycophenolate mofetil (cellcept(r) or mycophenolate sodium; ec-mps (myfortic (r) in stable renal allograft recipients under maintenance immunosuppressive therapy (cyclosporine +/- low dose glucocorticoids).

Eligibility criteria:
inclusion criteria: * patients \>18 years old * patients who are on stable immunosuppressive therapy for at least one month with ciclosporin, ec-mps or mmf +/- corticosteroids * renal transplantation, at least 6 months prior study inclusion * suitable and willing to switch treatment according to the study plan * women of childbearing potential must have a negative serum pregnancy test before study start and effective contraception must be used (method with pearl index \<1%) exclusion criteria: * patients with renal function \<30ml/min (estimated by cockcroft gault formula) * patients who are not on stable treatment with enzyme inductors or enzyme inhibitors for \<1 month before study entry * patients who take medication which is known for interfering with mpa absorption for \<1 month before study entry * known anamnestic hypersensitivity to one of the investigational products or drugs with similar chemical structure and to other components of the investigational products, respectively * patients on treatment with clopidogrel * acute rejection \< 1 month before study inclusion * patients who are hiv positive, hepatitis c virus (hcv) positive, hbsag positive * patients with gastrointestinal disorders which could affect resorption * pregnancy and/or lactation * drug or alcohol abuse in patient's history * patients with history of psychological illness or condition, which might interfere with the ability to understand the requirements, consequences, possible outcome of the study and patients who are not willing to give valid informed consent * patients with insufficient co-operation with the clinical investigator (e.g. suspicion of non-compliance)

Keywords: immunosuppressive medication mycophenolic acid interaction proton pump inhibitor pantoprazole renal transplant patients pharmacokinetics pharmacodynamics bioavailability
treating contact lens discomfort with orthokeratology

Conditions: Dry Eye; Contact Lens Complication

Summary: the primary aim of this study is to understand if orthokeratology can be used to improve contact lens comfort and the secondary aim is understand patient adaptation to orthokeratology.

orthokeratology has yet to be fully explored for the treatment of contact lens discomfort (cld), though some support for this practice exists in the literature. carracedo et al., lipson et al., and garcia-porta et al. found that orthokeratology resulted in better ocular comfort than soft contact lenses. nevertheless, all three studies excluded subjects who had been diagnosed with dry eye and all three studies used symptoms surveys that were not specific to assessing cld. garcia-porta et al.'s study was also limited by including both neophytes and established contact lens wearers. yet, these studies overall suggest that orthokeratology could be used as a treatment for cld, and one case report has even found that orthokeratology is a viable option for treating contact lens intolerance. to date, there has yet to be a study fully investigating orthokeratology as an alternative to soft contact lens use in patients with cld. therefore, the purpose of this study is to formally investigate if orthokeratology is a good alternative to soft contact lenses for patients who are experiencing cld or for patients who have dropped out of contact lenses because of cld. this study will also simultaneously evaluate the neophyte orthokeratology wearing experience with hopes of finding additional means for improving contact lens comfort. knowing the success of orthokeratology in wearers with cld will allow practitioners to better help and prescribe for those who may have experienced or at risk for experiencing cld. it may also be a way to allow patients additional years of contact lens wear.

Eligibility criteria:
inclusion criteria: * a completed comprehensive eye exam within the past two years * contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months * able to wear the emerald™ contact lens (oprifocon a, euclid systems corporation) * refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder * keratometry values between 40.00 d and 46.00 d exclusion criteria: * past orthokeratology use * ocular surgery within the past 12 months * history of severe ocular trauma * active ocular infection or inflammation * ocular disease other than dry eye * accutane or ocular medication use * pregnant or breast feeding * a condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation
home-based respiratory muscle strength training program for individuals with post-covid-19 persistent dyspnea

Conditions: Post-COVID-19 Syndrome; Dyspnea

Summary: to evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory breathing exercises compared to expiratory breathing exercises alone will help to improve shortness of breath, respiratory symptoms, breathing function, distance walked, and quality of life in those who are experiencing persistent shortness of breath after having had covid-19. measurements will take place at the beginning, 6 weeks, and at 12 weeks in the study.

to evaluate the extent to which a 12-week respiratory rehabilitation program consisting of inspiratory and expiratory muscle strength training exercises as compared to a prior study of expiratory muscle strength training alone is effective in improving dyspnea, respiratory symptoms, quantitative measures of pulmonary function, physical performance, and quality of life in individuals reporting persistent dyspnea post-covid-19 at baseline, six and twelve weeks.

Eligibility criteria:
inclusion criteria: * self-reported history of a positive covid-19 diagnosis in the past. * able to walk independently * cognitively intact * english-speaking * dyspnea at rest or with activity rated at 3 or greater on the dyspnea on exertion scale. * may use oxygen. * may be taking medications. exclusion criteria: * individuals who are wheelchair bound or who cannot walk independently. * individuals hospitalized for covid-19 who self-report that they received mechanical ventilation during hospitalization.

Keywords: respiratory muscle strength training respiratory symptoms