Kornimate/medical-research-clean huggingface dataset:
effects of insulin sensitizers in subjects with impaired glucose tolerance

Conditions: Glucose Metabolism Disorders; Diabetes

Summary: subjects with impaired glucose tolerance will be randomized to receive pioglitazone or metformin for 10 weeks. measurements of insulin sensitivity, body composition, glucose tolerance, and muscle lipid accumulation will be performed. adipose tissue and muscle biopsies are performed. the goal of the study is to determine whether the lipotoxiciy of impaired glucose tolerance is ameliorated by pioglitazone.

the progression to type 2 diabetes represents an evolution, which results from a vicious cycle where both glucotoxicity and lipotoxicity act to reduce insulin secretion and insulin action. lipotoxicity is a new concept, which refers to overaccumulation of lipids in non-adipose tissue reflecting increased free fatty acid delivery. increased fat content of skeletal muscle and islet cell is associated with insulin resistance and impaired pancreatic -cell function respectively in animal models. whether lipotoxicity is the link between obesity and diabetes, in humans, and whether reducing intracellular fat content will improve insulin secretion and sensitivity in humans is not known. in this study, we will focus on obese subjects with impaired glucose tolerance (igt) who have not yet developed glucose toxicity. we will examine insulin secretion, insulin action, hepatic glucose production, and muscle lipid metabolism in response to two insulin sensitizers with two different modes of action. we propose that thiazolidinediones will improve cell function by reversing lipotoxicity as reflective in reduced muscle lipid accumulation. hypothesis 1. in subjects with impaired glucose tolerance, who are insulin resistant and also have an insulin secretory defect, thiazolidinediones, but not biguanides, improve cell function. hypothesis 2. in subjects with impaired glucose tolerance, thiazolidinediones, but not biguanides, decrease the accumulation of fat in non-adipose tissues including muscle, pancreas, liver and myocardium. specific aim 1. fifty subjects with impaired glucose tolerance will be recruited and randomized to pioglitazone or metformin treatment specific aim 2. cell function will be evaluated by measuring changes in acute insulin response to glucose and non-glucose secretagogues in subjects with igt and it will be compared in response to treatment with pioglitazone versus metformin. specific aim 3. the muscle fat content will be evaluated as the surrogate measure for lipotoxicity and overaccumulation of fat in non-adipose tissue. from the muscle biopsy specimens, we will measure the amount of intramyocellular triglyceride before and after treatment with pioglitazone versus metformin. specific aim 4. adipose tissue cytokine expression is associated with changes in muscle lipid accumulation.

Eligibility criteria:
inclusion criteria: * impaired glucose tolerance * body mass index (bmi) of 28-38 exclusion criteria: * heart disease * renal disease * liver disease
correlation of measured and calculated serum osmolality during hyperosmolar drugs infusion in patients after craniotomy

Conditions: Brain Edema

Summary: osmotherapy has been used as the medical treatment for brain edema and intracranial hypertension in critically brain injured patients. measurement of serum osmolality during osmotherapy is of clinical importance to determine clinical efficacy, adjust dosage and avoid side effect. serum osmolality is often measured in laboratory by cryoscopic technique as the reference method. however, in clinical setting, routine measurement of serum osmolality is not feasible at bedside, either in intensive care unit (icu) or neurosurgical ward. therefore, clinicians usually estimate serum osmolality by using equations derived from serum osmoles that can be measured by bedside blood gas analysis or routine laboratory chemical analysis, such as sodium, potassium, urea, and glucose. in present study, mannitol or hypertonic saline will be used in patients after craniotomy, and serum osmolality will be measured before and during drug infusion. investigators hypothesize that the correlation of measured and calculated serum osmolality is better during infusion of hypertonic saline than mannitol.


Eligibility criteria:
inclusion criteria: * adult patients after elective craniotomy, requiring hyperosmolar agents for prevention or treatment of brain edema exclusion criteria: * age younger than 18 yr or older than 65 yr * history of diabetes * unstable hemodynamic condition * presence of renal failure

Keywords: hyperosmolar drugs mannitol hypertonic saline serum osmolality correlation
treatment patterns, clinical outcomes, and healthcare resource utilization associated with chinese patients with advanced lung cancer

Conditions: Lung Cancer; Non-small Cell Lung Cancer NSCLC; Small Cell Lung Cancer SCLC

Summary: the purpose of the study is to document real-world pattern of care, outcomes and health resource use for participants diagnosed with and receiving treatment for advanced non-small cell lung cancer (nsclc) and extensive disease small cell lung cancer (sclc) in china.


Eligibility criteria:
inclusion criteria: * histologically confirmed advanced nsclc (iiib/iv) and extensive disease sclc with pathology/cytology record between 1-dec-2013 and 30-nov-2014 * received inpatient treatment more than twice (inclusive) at a selected site. for hospitals with outpatient records, patients receiving oral tki therapy and routinely (more than twice a year) followed up outpatient will be included although no inpatient records. for hospitals with outpatient chemotherapy center, patients will be include if they were prescribed with chemotherapy and routinely (more than twice a year, inclusive) followed up outpatient in the hospital * 18 years of age or older at initial diagnosis of iiib/iv nsclc and extensive disease sclc exclusion criteria: * patients who have participated in or are attending clinical trials receiving active lc therapy * unknown initial diagnosis time and initial treatment time. * for hospitals without outpatient chemo therapy center, patients who were prescribed with chemo therapy but with no inpatient records will be excluded * patients who received inpatient therapy for one time and were not routinely (more than twice a year, inclusive) followed up outpatient will be excluded other protocol defined inclusion/exclusion criteria could apply
metabolic effects of alcohol

Conditions: Type 2 Diabetes Mellitus

Summary: the hypotheses to be tested are 1) the use of alcohol in the form of wine with the evening meal will lower plasma glucose during the night and result in lower fasting plasma glucose the next morning; 2) the chronic use of alcohol in moderation in the form of wine will have beneficial effects on plasma lipids in type 2 diabetic subjects.

the use of alcohol in moderation has been associated with reduced mortality rates, reduced risk of cardiovascular disease and reduced risk for type 2 diabetes. however, the effects of alcohol in persons with type 2 diabetes have not yet been defined. moreover, the possibility of alcohol induced hypoglycemia remains a safety concern. finally, little is known about the effects of alcohol on plasma lipids in people with diabetes. to address these issues, two substudies are proposed. the first substudy will examine the acute effects of alcohol in the form of wine at supper on postprandial and nocturnal glucose levels. the second substudy will examine the effects of alcohol in the form of wine consumed regularly for one month on plasma lipids. to test these hypotheses, 20 type 2 diabetics will be studied. in substudy 1, subjects will be admitted to the clinical research center for a two day inpatient stay. blood samples for plasma glucose and serum insulin will be obtained every two hours from 5:00 pm to 7:00 am. on one day, subjects will recieve 8 ounces of wine with dinner. on the other day, subjects will recieve 8 ounces of fruit juice with dinner. the primary endpoint of substudy 1 will be fasting plasma glucose. in substudy 2, subjects will be asked to consume 4-8 ounces of wine in the evening for one month and to abstain from wine and alcohol containing beverages for one month. fasting blood samples will be obtained after the month of wine consumption and after the month of abstention from alcohol for measurement of fasting lipids. the primary endpoint of substudy 2 will be fasting hdl cholesterol.

Eligibility criteria:
inclusion criteria: type 2 diabetes hba1c 6.0-8.0% age \> 40 years exclusion criteria: history of alcoholism or alcohol abuse liver disease blood pressure \> 150/90

Keywords: alcohol type 2 diabetes mellitus plama glucose hdl cholesterol
diffuse optical tomography (dot) for monitoring response to neoadjuvant (preoperative) chemotherapy in breast cancer

Conditions: Breast Neoplasms

Summary: the aim of the study is to determine if dot can detect response early in breast cancer patients undergoing neoadjuvant chemotherapy.

the pilot study will enrol up to ten patients over one year. patients receiving neoadjuvant chemotherapy for breast cancer will undergo baseline clinical examination, mammography, ultrasound, mri and dot before commencement of treatment. dot will be repeated at 1,3,6 weeks after chemotherapy, and at the end of each chemotherapy regimen. ultrasound will be repeated every 6 weeks and at the end of treatment. mammography and mri will be repeated once at the end of treatment before surgery. a breast pathologist will evaluate the subtype of breast cancer and the pathologic response of the operative specimen at the end of treatment. patient satisfaction questionnaires will be administered to evaluate their preferences for dot, ultrasound, mammography and mri scanning at the beginning and the end of the study.

Eligibility criteria:
inclusion criteria: * patients receiving neoadjuvant chemotherapy for breast cancer. * patients with locally advanced breast tumours or large operable tumours who require neoadjuvant treatment for downstaging. * histological confirmation of invasive breast carcinoma. * patients with metastatic disease may be eligible if they have oligometastatic disease and breast surgery after neoadjuvant chemotherapy is planned. * signed informed consent * age equal to or more than 21 years * life expectancy greater than 12 weeks. * ecog performance status 0-2 exclusion criteria: * fungating or ulcerated tumours * inability to provide informed consent * anticipated inability to follow-up patient for response to chemotherapy * any contraindication to undergoing ultrasound, mri, mmg or dot

Keywords: diffuse optical tomography response neoadjuvant chemotherapy breast cancer
comparison of two flow rates of hhhfnc to prevent extubation failure in preterm infants

Conditions: Prematurity, Mechanical Ventilation

Summary: this is a randomized controlled trial (rct) to evaluate the influence of two flow rates (6 liter/min versus 3 liter/min) of heated-humidified high-flow-nasal-cannula (hhhfnc) on rates of extubation failure in mechanically ventilated preterm infants.

hhhfnc has been proposed as an alternative to nasal continuous positive airway pressure (ncpap) in neonatal intensive care units (nicus) for preventing extubation failure. in a recent international survey on periextubation practices in extremely preterm infants, ncpap was the most common type of respiratory support used (84%) followed by nasal intermittent positive pressure ventilation (55%) and hhhfnc (33%). moreover, hhhfnc appears to have efficacy and safety similar to those of ncpap when applied immediately post-extubation to prevent extubation failure in preterm infants. and resulted in significantly less nasal trauma in the first 7 days post-extubation than ncpap. however, the best flow rates of hhhfnc to prevent extubation failure remains to be known. this rct aims to compare the efficacy and safety of postextubation respiratory support via hhhfnc at two different flow rates (6 l/min. versus 3 l/min) regarding successful extubation after a period of endotracheal positive pressure ventilation. we hypothesized that postextubation respiratory support via hhhfnc at a flow rate of 6 l/min. will result in a greater proportion of preterm infants being successfully extubated after a period of endotracheal positive pressure ventilation compared with hhhfnc at a flow rate of 3 l/min.

Eligibility criteria:
inclusion criteria: * infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. infants will be enrolled after written informed parental consent is obtained. exclusion criteria: * suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations
a comparison between the exoskeleton hybrid assistive limb and conventional gait training early after stroke

Conditions: Stroke; Gait, Hemiplegic; Ambulation Difficulty; Hemiparesis

Summary: overall aim is to evaluate hal for gait training early after stroke and the effect of hal on short- and long-term functioning, disability and health compared to conventional gait training as part of an inpatient rehabilitation program early after stroke.

to compare outcome after 4 weeks of gait training with hal vs. 4 weeks of conventional gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely limited mobility early after stroke. study design: randomized, controlled study with blinded outcome assessment. conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. conventional gait training is offered to both study groups. training with hal is performed in 1 session per day, 4 days per week during 4 weeks. time for each session is individualised but does not exceed 60 minutes/session (effective time). training with hal is performed in combination with body-weight support system and on a treadmill. the training program is performed by 2 physiotherapists, who have been trained in the hal method.

Eligibility criteria:
inclusion criteria: * less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. fac score 0-1), able to sit on a bench with or-without supervision at least five minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; body size compatible with the hal suit. exclusion criteria: * contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.

Keywords: rehabilitation robotics
a phase 1 study of pf-00868554 in hepatitis c virus (hcv) positive patients

Conditions: Hepatitis C

Summary: assess the safety, tolerability and pharmacokinetics of multiple oral doses of pf-00868554 in hcv positive patient volunteers


Eligibility criteria:
inclusion criteria: * hcv rna ≥ 100,000 iu/ml at screening * genotype 1a or 1b exclusion criteria: * current or prior treatment with ifn and/or rbv * evidence of decompensated liver disease
effect of non-alcoholic beer in cirrhosis

Conditions: Endothelial Dysfunction; Nutritional Status; Quality of Life

Summary: the implementation of nutritional strategies targeting several variables at once could benefit patients with cirrhosis. non-alcoholic beer has different compounds derived from hops that exert antioxidant, anti-inflammatory and nutritional properties. the aim of this study is to evaluate the effect of diet + exercise and non-alcoholic beer on nutritional status, endothelial function and quality of life in patients with cirrhosis.


Eligibility criteria:
inclusion criteria: * liver cirrhosis of any aetiology (liver biopsy or a combination of clinical and biochemical variables plus evidence of portal hypertension); without decompensation during the past month; serum creatinine \<1.5 mg%; able to attend the appointed visits and willing to participate in the study. exclusion criteria: * severe concomitant cardiopulmonary diseases; decompensated type 2 diabetes mellitus, insulin use or proliferative diabetic retinopathy; orthopedic or osteomuscular limitations; any type of cancer; primary sclerosing cholangitis and inflammatory bowel disease.

Keywords: cirrhosis nutrition sarcopenia non-alcoholic beer
autologous bone marrow-derived stem cells transplantation for retinitis pigmentosa

Conditions: Retinitis Pigmentosa

Summary: the purpose of this study is to evaluate the short-term safety and efficacy of a single intravitreal injection of autologous bone marrow stem cells in patients with retinitis pigmentosa.

a prospective phase ii, nonrandomized open-label study of retinitis pigmentosa patients with best-corrected etdrs visual acuity (bcva) worse than 20/200. standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . three measures will be used to evaluate the short-term safety of intravitreal of abmdsc: 1) severe visual loss, defined as a drop in 15 letters on etdrs visual acuity scale; 2) decrease in erg response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in cmt more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of abmdsc: 1) improvement in erg response; 2) increase in visual field: 3) increase in csmt \> 50um and not related to macular edema; 4) increase \> 5 letters on bcva

Eligibility criteria:
inclusion criteria: * diagnosis of retinitis pigmentosa logarithm of minimum angle of resolution (logmar) bcva of 1.0 (snellen equivalent, 20/200) or worse * visual field less than 20 degreees exclusion criteria: * previous ocular surgery other than cataract * presence of cataract or other media opacity that would influence ocular fundus documentation and adequate erg and visual field evaluation * other ophthalmic disease like glaucoma and uveitis * previous history of blood disorders like leukemia * known allergy to fluorescein or indocyanine green * known coagulation abnormalities or current use of anticoagulative medication other than aspirin.

Keywords: retinitis pigmentosa stem cell bone marrow retinal dysprophy
the impact of vitamins and minerals supplementation on neuropathy and nephropathy complications

Conditions: Type 2 Diabetes

Summary: the combination of vitamin and mineral supplementation may improve: * glycemic control * lipid profile * oxidative stress * blood pressure * nephropathy indices * neuropathy indices

a total of 75 diabetic patients (39 men and 36 women), aged 36 to 69 years, having diabetes for at least 3 years, was recruited for this study. type 2 diabetes was defined as fasting plasma glucose 126 mg/dl (two times repeated) or taking oral glucose-lowering agents.diabetic patients were stratified by sex and randomly assigned to one of the three treatment groups using block randomization procedure. depending upon the treatment groups, each subject received two capsules per day, 1 with breakfast and 1 with dinner, for a period of 4 months. each capsule contained one of the following preparations and hence determined the corresponding groups: group mv: zinc sulfate and magnesium oxide (providing 10 mg zn and 125 mg mg) and vitamin c (100 mg) and vitamin e (100 mg); group mvb: both of the above mineral and vitamin supplements plus vitamin b1 (5 mg), vitamin b2 (5 mg), vitamin b6 (5 mg), biotin (50 µg), vitamin b12 (5 µg) and folic acid (0.5 mg); group p: starch (placebo). all of the study medications, including the placebo, were supplied by pharmaceutical sciences research center (tehran university of medical sciences, iran) and were indistinguishable from each other. they were stored at 20-25 0c.

Eligibility criteria:
inclusion criteria: * type 2 diabetes for 3 years exclusion criteria: * resting blood pressure \>160/100 mmhg * taking vitamin and/or mineral supplement, thyroid hormones, estrogens, progesterone, diuretics or antihypertensive agents * having history of myocardial infarction and hepatic disease * pregnant

Keywords: type 2 diabetes micronutrients nephropathy neuropathy
apatinib plus shr1210 in advanced mucosal melanoma

Conditions: Mucosal Melanoma; Advanced Cancer; Apatinib; SHR-1210

Summary: there is still no effective treatment for advanced mucosal melanoma at present. the efficacy of single-agent pd-1 inhibitors is less than 20%. it is urgent to explore regimens to improve the efficacy of pd-1 inhibitors in patients with advanced mucosal melanoma. this study is performed to explore the safety and efficacy of apatinib plus shr-1210 in patients with advanced mucosa melanoma whose diseases progress after chemotherapy.

apatinib is an oral small molecule anti-angiogenesis inhibitors. it inhibits vegfr-2 tyrosine kinase activity, thereby blocking vegf-induced signaling and exerting a strong inhibitory effect on tumor angiogenesis.apatinib has shown anti-melanoma activity in retrospective study. however, the efficacy is still very low. shr-1210 is an anti-pd-1 antibody produced by hengrui pharmaceutical co., ltd. apatinib plus shr-1210 has shown synergy in several malignancies. this study is conducted to explore the efficacy and safety in advanced mucosa melanoma

Eligibility criteria:
inclusion criteria: * mucosal melanoma by pathology * expected lifespan ≥ 3 months * ecog 0-2 * failure after one kind of chemotherapeutic regimen * at least one measurable lesion by recist 1.1 * enough organ function * blood pressure is normal; for patients with hypertension the blood pressure should be controlled in normal by antihypertensive drugs * no other serious diseases conflicting with this regimen * no history of other malignancies * pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study * informed consent from the patient exclusion criteria: * suffering from serious infectious diseases within 4 weeks before enrollment * requiring intermittent use of bronchodilators or medical interventions * usage of immunosuppressants before enrollment and the dose of immunosuppressant used ≥ 10mg / day oral prednisone for more than 2 weeks * serious allergy * serious mental diseases * abnormal coagulation funtion,bleeding tendency or receiving thrombolytic or anticoagulant therapy * abdominal fistula, gastrointestinal perforation, or abdominal abscess within 4 weeks prior to enrollment * previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe lung damage, etc. * other situations evaluated by investigator unsuitable for this study