Kornimate/medical-research-clean huggingface dataset:
konjac-glucomannan fibre blend and american ginseng in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study was to determine whether the co-administration of a konjac-glucomannan fibre blend and american ginseng in a randomized, placebo-controlled, cross-over trial can improve diabetes management.

the study used a partially blinded, randomized, placebo controlled, crossover design. due to the nature of the fibres it was not possible to blind the participant with respect to type of fibre. the study was divided into two phases with each phase having a four 4-week run-in period, and a 12-week treatment period, separated by a minimum 4-week wash-out period. the treatments consisted of an ad libitum canadian diabetes association recommended diet supplemented with capsules which contained either cornstarch (control) or ag (test) and a fiber supplement consisting of either wheat bran (control) or a viscous fiber blend of konjac mannan and xanthan (test). participants were asked to attend the clinic at weeks -4, 0, 3, 6, and 12 during each phase. outcome measures there were three levels of outcome measures including efficacy, safety, and compliance. statistical analysis the results are presented as mean ± sem and considered statistically significant at p\<0.05. statistical analysis was performed using the sas version 8.2 (sas institute, cary, nc). parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (shapiro-wilk and kolmogorov-smirnov tests). glm was used to perform two-way anova to detect differences of outcome variables in treatments and visits, controlling for treatment sequence and sex. if the effect of treatment was significant then percent differences were calculated between weeks 12 of test and control and analyzed using the glm repeated measures one-way anova controlling for sex. parametric analyses were conducted following a comparison of the sampling distribution to a normal distribution (shapiro-wilk and kolmogorov-smirnov tests). the tests did not reject the null hypothesis at α=0.05. all comparisons were paired, thus each participant served as his/her own control. as this was a cross-over study, only participants who completed the study were included in the analysis.

Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes of at least 1 year * age between 40 and 75 years old * treated with diet and anti hyperglycemic medications * hba1c between 6.5% and 8.4% * systolic blood pressure \<140mmhg * diastolic blood pressure \<90mmhg * clinically euthyroid * normal renal and liver function exclusion criteria: * treated with insulin * age less than 40 or older than 75 years old at the start of the trial

Keywords: american ginseng konjac glucomannan fiber
effect of maternal supplementation from preconception to lactation on child growth and development

Conditions: Malnutrition; Growth &Amp; Development

Summary: the goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. the main questions it aims to answer are: * does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child neurodevelopment? * does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child growth? this is a cross-sectional follow up study to a substudy of breastmilk composition and infant growth within the matiari empowerment and preconception supplementation (mapps) trial, wherein mothers were randomized to receive a multiple micronutrient supplement from preconception through to lactation or the standard of care (clinicaltrials.gov identifier: nct04451395).


Eligibility criteria:
inclusion criteria: * child participated in the mapps trial breastmilk sub-study at 3-months of age * child has reached their fourth birthday * child is available in the study catchment area (matiari district)

Keywords: malnutrition multiple micronutrient supplement neurodevelopment growth
effect of low-calorie diet and orange juice on body weight and metabolic parameters of obese subjects

Conditions: Obesity

Summary: this study aimed to verify if combination of a low calorie diet and orange juice consumption results in weight loss and ameliorates metabolic obesity-related biomarkers.

seventy-eight obese subjects aged 36 ± 1 years and bmi of 33 ± 3 kg were randomly divided into two parallel groups: (1) orange juice (n = 39), composed of individuals subjected to a diet low caloric diet and plus intake of 500 ml orange juice; (2) control (n = 39) composed of individuals subjected to a diet low in calories. the recruitment process began in september 2015, the intervention was carried out from october 2015 to january 2016, and the data analysis started in february 2016. the sample number took into account variances on body weight with a type i error α = 0.05 and a type ii error β = 0.2 (80% power). the minimum sample size should have 36 individuals per group (n = 72), considering an approximately 15% dropout rate. thus, the final sample size of study was constituted by 39 individuals per group (n = 78). primary and secondary endpoints were the reduction of weight and modification of the levels of obesity-related metabolic biomarkers, respectively. normality and homogeneity of data were tested. t-test was conducted to identify possible differences between oj and control groups at baseline. a linear mixed-effects model was apply to determine the time effect within and between groups (post hoc), and p significance was set up ≤ 0.05. the assessment of body composition, metabolic biomarkers and food intake were analyzed over a 12-week intervention.

Eligibility criteria:
inclusion criteria: * 30 \> bmi \< 40 kg/m2 exclusion criteria: * dieting last year, * use of drugs, vitamins and dietary supplements * alcohol consumption (\> 20 g alcohol/d) * intense physical activity (\> 5 hours/week).

Keywords: orange juice low-calorie diet body composition weight-loss metabolic biomarkers obese
abnormal placenta plant disease early diagnosis and individualized treatment research

Conditions: Scarred Uterus

Summary: as the "two-child" policy implementation, caesarean women's clinical pregnancy is a huge problem again, especially the placenta planting abnormal disease is a serious threat to the maternal health and life. through this research, the investigators can obtain relevant epidemiological data and provide objective data for the department of public health policy; predicting an placenta abnormal planting early diagnosis model was constructed, it will fill the blank in this field, and high-risk groups in the early stages of pregnancy will be taken proper disposal, the related complications will be reduced to ensure the safety of maternal.

this study focus on four hands: (1) to investigate different types of gestational sac implantation for pregnancy in caesarean women of childbearing age;(2) to explore the relationship between abnormal placenta planting disease in middle-late pregnancy and the different types of scar pregnancy (3) to explore the the value of ultrasound and serological markers for early diagnosis of placenta planting disease from scar pregnancy; (4) to compare the end and the influence of health economy of different termination method on scar pregnancy.

Eligibility criteria:
inclusion criteria: * single pregnancies with once cesarean section history * see a doctor before gestational 8 weeks in our study center * will continue to pregnancy, high patient compliance exclusion criteria: * twins or multiple pregnancies * hysteromyoma or adenomyoma stripping history * history of intrauterine adhesions

Keywords: scar pregnancy placenta planting abnormal disease early diagnosis individualized treatment
use of misoprostol in case of insertion failure of intrauterine contraceptives

Conditions: Cervical Stenosis

Summary: to assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled randomized clinical trial)to facilitate the insertion of copper-iud and the levonorgestrel-releasing intrauterine system (lng-ius) in cases of failure due to cervical stenosis in either nulligravidas and parous women. additionally to evaluate the side-effects of the misoprostol. the hypothesis is that misoprostol may be better than placebo.

women attended at the family planning clinic of the university of campinas who requested the insertion of a copper-iud or an lng-ius and who failed in the attempt due to cervical stenosis will be randomized in two groups (1:1). the study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion and the control group will receive placebo in the same schedule. the sample will be 50 women in each group. after 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. at this time we will evaluate if the insertion was able to do or not. the data will be analyzing with χ2 test for independent samples. after that a multiple logistic analysis will be perform to evaluate the associated variables with the result (failure or successful) insertion. the level of significance will be established at p\<.005.

Eligibility criteria:
inclusion criteria: women aged \> 18 and \<50 years old; requesting insertion of and iud or an lng-ius failure of iud insertion exclusion criteria: refuse to participate lost to follow-up at the return visit

Keywords: intrauterine device insertion failure
predictors of respiratory failure in sars-cov-2 infection

Conditions: SARS-CoV-2 Pneumonia

Summary: the emergence of sars-cov-2 is currently engaging and consuming most of resources of efficient healthcare systems in europe, and several hospitals are currently experiencing a shortage of icu beds for critically-ill patients with sars-cov-2 pneumonia. a risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need icu admission and/or those who may benefit from a prompt antiviral therapy

the study will compared patients with and without respiratory failure in order to find risk factors for need for icu admission. a simple score based on risk factors will be created from a multicenter italian cohort and validated in a multicenter international cohort.

Eligibility criteria:
inclusion criteria: * hospitalized patients with microbiologically confirmed diagnosis of sars-cov-2 infection * age \> 17 years exclusion criteria: * invasive mechanical ventilation within 12 hours from hospital admission
a study of pegasys (peginterferon alfa-2a (40kd)) in combination with copegus (ribavirin) in interferon-naive patients with chronic hepatitis c infection (chc).

Conditions: Hepatitis C, Chronic

Summary: the effects of treatment with different doses of pegasys in combination with different doses of ribavirin will be evaluated in patients with chc genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. the anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients \>=18 years of age; * body weight \>85kg (187lbs); * chc (genotype 1); * liver biopsy (in \<24 calendar months of first dose), with results consistent with chc infection; * use of 2 forms of contraception during study and 6 months after the study in both men and women. exclusion criteria: * women who are pregnant or breastfeeding; * male partners of women who are pregnant; * conditions associated with decompensated liver disease; * other forms of liver disease, including liver cancer; * human immunodeficiency virus infection; * previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.
myocardial salvage and contrast dye induced nephropathy reduction by n-acetylcystein

Conditions: Myocardial Infarction

Summary: acetylcystein is a potent antioxidans which is able to prevent contrast dye induced nephropathy in stable patients undergoing additional hydration. in primary percutaneous intervention for infarction hydration is not possible. therefore acetylcystein might prevent contrast dye induced nephropathy. furthermore, it might reduce infarct size as a result of its antioxidant properties. clinical trials are missing so far examining the effects of acetylcystein on nephropathy and infarct size.


Eligibility criteria:
inclusion criteria: * st-elevation infarction (\<12 hours) * angina exclusion criteria: * prior fibrinolysis * dialysis * pregnancy * lactase-reduction * glucose-galactose malabsorption * known allergy to acetylcystein

Keywords: primary pci nephropathy infarct size infarction st-elevation myocardial infarction
ti-001 (intranasal oxytocin) for treatment of high frequency episodic migraine and chronic migraine

Conditions: High Frequency Episodic Migraine and Chronic Migraine

Summary: this study evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.


Eligibility criteria:
inclusion criteria: 1. men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine. exclusion criteria: 1. known allergy to oxytocin 2. history of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder 3. history of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results 4. have basilar or hemiplegic migraines 5. have substantial cognitive or memory impairment due to any cause (eg, alzheimer's or dementia) 6. have a nasal obstruction due to any cause 7. are pregnant or breast feeding 8. require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs 9. are unable or unwilling to provide informed consent or to follow study procedures

Keywords: refractory chronic migraine medically intractable chronic migraine oxytocin intranasal oxytocin
a clinical trial to evaluate the safety and efficacy of rreproxalap in adults with dry eye disease

Conditions: Dry Eye Syndromes

Summary: a randomized, double-masked, vehicle-controlled crossover clinical trial to assess efficacy and safety of 0.25% reproxalap ophthalmic solution compared to vehicle in subjects with dry eye disease


Eligibility criteria:
inclusion criteria: 1. eighteen (18) to 70 years of age at the time of screening (either gender and any race) 2. ability to provide written informed consent 3. reported history of dry eye for at least 6 months prior to screening 4. reported history of the use of eye drops for dry eye disease between 2 weeks to 6 months prior to screening exclusion criteria: 1. diagnosis of an ongoing ocular infection (bacterial, viral, or fungal), active ocular inflammation, or history of inflammatory disease (that, in the opinion of the investigator, could interfere with study conduct or assessments) at screening 2. contact lens use within 7 days of screening or anticipate using contact lenses during the trial 3. systemic corticosteroid or other immunomodulatory therapy (not including inhaled corticosteroids) within 60 days of screening, or any planned immunomodulatory therapy throughout the study period 4. women of childbearing potential (wocbp) who are pregnant and nursing 5. if participant is of childbearing potential (female or male), unwillingness to use an acceptable means of birth control. 6. known allergy and/or sensitivity to reproxalap or the drug product vehicle 7. a condition that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial 8. inability or unwillingness to follow instructions, including participation in all study assessments/procedures and visits

Keywords: dry eye disease reproxalap aldeyra adx-102
autologous bm-msc transplantation in combination with platelet lysate (pl) for nonunion treatment

Conditions: Bone Fracture

Summary: nonunion of long bones would occur in almost 10% of fractures and because of its long term and complicated treatment, is known as a therapeutic challenge for both of the surgeons and patients. cell therapy is useful in treatment of nonunion and mesenchymal stromal/stem cells are the best candidates for this kind of treatment. percutaneous implantation of autologous bone marrow derived mesenchymal stromal/stem cell in combination with pl will be done in 30 patients with tibia nonunion. the other 30 patients as the control group will receive placebo. the patients will be followed at 2weeks, 3months, 6m and 12 months after implantation. the spss(v16) software will be used for data analysis.

long bone nonunion is known as a therapeutic challenge for both the orthopedic surgeons and the society. current treatment of this disorder is autologous bone graft. this treatment has potential minor and major complications and is considered as a risky treatment. so researches are focused on new treatment approaches for this disease. cell therapy is one of these new approaches especially based on mesenchymal stromal cells. the investigators will evaluate safety and efficacy of percutaneous implantation of autologous bm-msc (bone marrow -derived mesenchymal stromal cell) in combination with pl (platelet lysate product) in 30 tibia nonunion patients. the other 30 patients will receive placebo. these patients will be followed up and data will be analyzed with spss(v16).

Eligibility criteria:
inclusion criteria: * non-united fracture of tibial midshaft at x-ray. * non-united gap less than 1cm. * fracture has fixed by closed intramedullary rod. * hypotrophic type. * at least 6 months after initial surgery. * patient informed consent. exclusion criteria: * infected nonunion * multiple major fracture * non treated major fracture * malignancy * pregnancy or lactating * uncontrolled chronic diseases, such as: diabetes mellitus, hypertension, renal diseases, liver diseases, thyroid diseases, heart diseases, blood diseases, etc. * steroid usage. * positive test for hiv and/or hbs and/or hbc and/or htlv (1,2) * fracture site more than 1 cm.

Keywords: autologous nonunion fracture bone marrow mesenchymal stromal cell platelet lysate product
acute effects after stretching respiratory muscles on ventilatory pattern and volume distribution of chest wall

Conditions: Stroke

Summary: the purpose of study is to evaluate the acute effects of respiratory muscles stretching on ventilator pattern and volume distribution of chest wall in patients with right hemiparesis post-stroke and our hypothesis is that the use of rms will be able to improve changes in the respiratory function.

all study protocol will be performing in three different days. in the first day, the participants will undergo to the initial assessment, which consisted of anamnesis and anthropometric measurements: weight, height and body mass index (bmi). then, they will be submitting to spirometry and respiratory muscle pressure using a manovacuometer. all patients will submit underwent two types of intervention: respiratory muscles stretching (rms) and remain at rest (control group). the stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will use for each stretching pattern with an interval of 30 seconds between series. for the intervention in the control group, all volunteers will be position at rest in a comfortable in a chair during 20 minutes.

Eligibility criteria:
inclusion criteria: * patients post-stroke with right hemiparesis no more than 3 months, from both sexes, aged above 20 years, score between 1 and 3 according to ashworth scale for upper limbs, score above 85 according to barthel index and a minimum punctuation of 18 for mini mental state examination. exclusion criteria: * volunteers presenting facial paralysis; rheumatic or orthopedic diseases; spinal abnormalities or deformities that compromise the respiratory mechanics; spirometry with forced expired volume in the first second (fev1) bellow 80% from predicted values and fev1∕forced vital capacity (fvc) ≤ .7; presenting respiratory comorbidities; recent history of thoracic or abdominal surgery; hemodynamic instability or pregnancy.

Keywords: stroke stretching respiratory muscle ventilatory pattern optoelectronic plethysmography
effect of structured exercise in patients with knee osteoarthritis

Conditions: Osteoarthritis, Knee; Physical Inactivity

Summary: the aim of this randomized controlled trial is to evaluate the effect of nordic walking and inspiratory muscle training (imt) on cardiopulmonary function in patients with knee osteoarthritis (oa). mild-to-moderate knee oa patients are randomly allocated into experimental group (nordic walking plus routine management) or control group (routine management). while end-stage knee oa patients are randomly allocated into experimental group (imt plus pre-operative rehabilitation exercise) or control group (pre-operative rehabilitation exercise). participants are invited to undergo two assessments, including baseline assessment, post-intervention assessment. researchers will compare two groups to see if the cardiopulmonary function can be improved after intervention.

this study recruits patients with different stages and assigns them into different interventions and comparing the effect with those not receiving intervention. it will provide the evidence in terms of the exercise that can promote cardiopulmonary function and at the same time reduce pain and disability for patients with different stages of knee osteoarthritis.

Eligibility criteria:
inclusion criteria: * pain on the most days in one or both knees in the past month; * difficulty with at least one of daily living activities measured by the western ontario and mcmaster universities osteoarthritis index (womac) scale; * radiographic evidence of knee oa in the tibial-femoral compartment (kellgren and lawrence grade, k/l ≥1, k/l 1-3 regarded as mild-to-moderate knee oa, others waiting for knee arthroplasty regarded as end-stage knee oa); * with normal or corrected visual and auditory function and walking unaided; * primary knee oa for more than 6 months, be stable on medication for at least 3 weeks. exclusion criteria: * knee surgery priorly; * have steroid injection in previous three weeks; * have inflammatory arthritis (e.g., rheumatoid); or unstable angina, or myocardial infarction, or cardiac surgery; or stroke; or treatment with steroids, hormones, or cancer chemotherapy; or pulmonary diseases (force vital capacity\<80% of predicted and/or forced expiratory volume at first second\<70% of predicted); or a history of exercise-induced asthma; * unable to understand the procedure and potential risks of the study; * medically unstable that indicate unsafe to participate in exercise test

Keywords: exercise pain function