Kornimate/medical-research-clean huggingface dataset:
to compare the safety, tolerability, and pharmacokinetics of qbx258 in patients with asthma

Conditions: Asthma

Summary: this study is designed to compare the safety, tolerability, and pharmacokinetics of qbx258 (sequential administration of a fixed dose of vak694 and single ascending doses of qax576) in patients with well-controlled mild to moderate asthma.


Eligibility criteria:
inclusion criteria: * male and female subjects age 18-60 years (inclusive) * well controlled mild to moderate atopic asthma * female subjects must be post-menopausal or surgically sterile * male subjects must be using two methods of contraception * subjects must have a positive skin prick test to one or more common airborne allergen exclusion criteria: * participation in any clinical investigation or use of other investigational drugs at time of enrollment * a history of clinically significant ecg abnormalities * history of malignancy of any organ system * smokers (use of tobacco products in the previous 3 months) * use of prescription drugs other than those required for control and relief of asthma * use of oral steroids within 12 weeks prior to dosing * fevi \< 80% predicted at screening or baseline * use of albuterol more than twice a week for relief of asthma * patients suffering from active hay fever at baseline or likely to require treatment during the study * history of chronic respiratory disease other than asthma or chronic allergic rhinitis * emergency room visit within 6 weeks of screening due to asthma * hospitalization for asthma in the last year * history of intubation/assisted ventilation for asthma in the last 5 years * administration of live vaccines within the preceding month other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma vak694 qax576 qbx258 pharmacokinetics
pharmacokinetics/pharmacodynamics biomarker study in active ulcerative colitis patients

Conditions: Colitis, Ulcerative

Summary: this study represents the first investigation of anrukinzumab in patients with active ulcerative colitis (uc) and will evaluate proof of mechanism by changes in the mechanism based biomarker (ykl 40) and pharmacodynamic biomarkers (fecal calprotectin, lactoferrin and hs-crp). it will provide further assessment of the safety, tolerability, and pharmacokinetics (pk) by administration of multiple intravenous (iv) doses of anrukinzumab.


Eligibility criteria:
inclusion criteria: * male or female, age \>=18 and \<=65 years * active ulcerative colitis (uc) beyond the rectum based upon mayo score * women of childbearing potential with highly effective method of contraception exclusion criteria: * indeterminate disease status, crohn's disease, ischemic colitis, positive hiv, positive or history of tuberculosis infection, active enteric infections, transplant organ recipient, concomitant steroids, immunosuppressives or anti-tnfs.

Keywords: active ulcerative colitis phase 2a double-blind randomized pk/pd biomarker study
characteristics of type 2 diabetes patients, treated with insulin and their follow up care in guadeloupe

Conditions: Type 2 Diabetes Treated With Insulin

Summary: type 2 diabetes is a major problem of public health in the french west indies, with an estimated prevalence of 8%, twice more than in france. in guadeloupe, according to the statistical data of hospital morbidity in 2004, 2643 hospital stays were diagnosed with diabetes. these cases mainly concerned woman (62%) and the elderly, from 45 to 74 years old (67%). the main objective of this research is to describe the insulin protocol used in guadeloupe for treated type 2 diabetes patients and their characteristics: * the duration of the type 2 diabetes * time elapsing between the diagnosis and the treatment by insulin * where the follow up care took place * existence of complications secondary objectives were to describe the link between the hba1c rate and the insulin therapy protocol. and also to present the main inconveniences expressed by patients and their degree of autonomy.

nowadays the set up for insulin treatment is available in general practitioners' offices. however, it is restrained by the reticence of patients and physicians. for type 2 diabetes, insulin therapy is well managed and there is ongoing progress. but there are still some questions about the effect of the treatment in the everyday life of patients: culture, fear, material resources, necessity of education. ignorance and prejudices on insulin injection are still prevalent and often it delays for more than a year the time when patients have to switch an insulin treatment for unbalanced chronic disorder. type 2 diabetes patients think that the treatment is heavy, can lead to serious hypoglycemia, is uncomfortable for family and can cause fear. education of the patients can reduce ignorance and prejudices about insulin treatment. nowadays studies show that diabetes patients want to be more involved in the decisions linked to their treatment which impact their perception of the disease and the treatment. auto measurement of glycaemia can help the patient better manage his disease and make him understand the importance of controlling his glycaemia levels. this study could allow to: * offer a new care organization for a better use of resources (network, patient therapeutic education...) * set up adequate training for professionals and for patients being cared for in medical offices. * improve the glycemic balance of patients and slower the growth of degenerative complications.

Eligibility criteria:
inclusion criteria: * men or woman * age ≥ 18 years old * patient with type 2 diabetes, treated with insulin for at least one year * patient accepting to participate to the study exclusion criteria: • pregnant or breastfeeding woman

Keywords: type 2 diabetes insulin hb1ac glycemia guadeloupe
comparative effects of jacobson's relaxation techniques and stretching exercises in preeclampsia

Conditions: Pre-Eclampsia; Complicating Pregnancy

Summary: to compare the effect of jacobson's relaxation techniques and stretching exercises on preeclampsia in pregnant women.

the effectiveness of jacobson's progressive muscle relaxation technique on maternal, fetal, and neonatal outcomes in women with non-severe preeclampsiain have been studied in an rct study. pregnant women who use this technique experience reduced muscle tension and a sense of calm. in one of the study the effect of relaxation techniques on blood pressure and stress among pregnant women with mild pregnancy induced hypertension were investigated in which women with mild pregnancy-induced hypertension who used relaxation techniques saw significant improvements in their knowledge, physiological parameters, and blood pressure as well as a reduction in stress. to the best of the researcher's knowledge, no comparative study has been done to yet to evaluate the efficacy of relaxation and stretching exercise. there is not enough data to determine whether jacobson's relaxation techniques and stretching exercise reduce preeclampsia in pregnant women. as a result, this study will contribute to the expanding body of knowledge about which approach should be used as an alternative if results from other procedures are comparable

Eligibility criteria:
inclusion criteria: * gestational age was exceeding 24 weeks * bp more than or up to 140/90 * diagnosed with gestational hypertension * primiparous exclusion criteria: * women with history of preterm labor or repeated abortion * bleeding * intra uterine fetal growth anomalies * underlying mental (depression with severe anxiety) * cardio respiratory diseases

Keywords: pregnancy toxemia, muscle stretching exercise high blood pressure
advancing telestroke care: a prospective observational study

Conditions: Stroke

Summary: this study will promote the development and economic sustainability of telemedicine for acute stroke treatment.

the goal of this study is to promote the development and economic sustainability of telemedicine for acute stroke treatment. the study's objectives are 1) to determine if the use of telemedicine consultations for stroke patients will improve their care per guidelines compared to stroke patients treated by control hospitals; and 2) to determine if the care per guidelines provided via telemedicine consultations for stroke patients will be similar or equivalent to care per guidelines provided to stroke patients treated at hub hospitals. the advancing telestroke care study will establish treatment and outcomes in three distinct study cohorts: hub telemedicine hospital, spoke telemedicine hospital and non-telemedicine control hospital.

Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years old * acute ischemic stroke within 12 hours of stroke onset exclusion criteria: * life expectancy less than 90 days * patient unwilling to participate in study

Keywords: stroke telemedicine telestroke
efficacy of local direct median nerve block

Conditions: Carpal Tunnel Syndrome; Anesthesia, Local

Summary: carpal tunnel syndrome is the most common compressive neuropathy. carpal tunnel release is indicated when failed conservative treatment. although it can be done either with local anesthesia or brachial plexus block, there is no gold standard of anesthetic choice. the study is conducted to compare the efficacy of two methods and we hypothesized that the local direct median nerve block has effectiveness in intraoperative pain control not inferior to brachial plexus block in endoscopic carpal tunnel release.

the study is randomized-control trial conducted in single center (orthopaedic department, faculty of medicine, thammasat university) the patients with failed conservative treatment of carpal tunnel syndrome confirmed by emg are enrolled and ramdomized with computerized block-of-4 method.the local direct median nerve block is done by the surgeon and brachial plexus block in done by single anesthesiologist after that the patient will be operated with 1-portal endoscopic carpal tunnel release (agee technque) by single surgeon. immediate postoperative the blinded observer will ask the patient about interaoperative pain in visual analog scale then the pateint is asked to record the 2-hr, 4-hr ,6-hr and 12-hr postoperative pain in case record form.the patient will return the case record form at 2-week and also stitched off the wound then next follow up will be 4, 12, 24 weeks to assess functional outcome (thai version bonton questionaire)

Eligibility criteria:
inclusion criteria: 1. patient with carpal tunnel syndrome, confirmed by emg 2. failed conservative treatment 3 months 3. age ≥18 years old exclusion criteria: 1. allergic history of xylocaine 2. any other condition that can cause carpal tunnel syndrome or peripheral neuropathy e.g. dm, hypothyroidism, pregnancy, tumor 3. any patient that has been coverted to open carpal tunnel release

Keywords: endoscopic carpal tunnel release
effects of intravenous (iv) omadacycline on gut microbiome

Conditions: Microbial Colonization

Summary: given the clinical need to improve upon current antibiotic regimens for the treatment of c. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of intravenous (iv) omadacycline on gut microbiome of healthy volunteers.

the plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of iv omadacycline on gut microbiome.

Eligibility criteria:
inclusion criteria: * 18-40 years of age * willing and able to comply with all study procedures * considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease * males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline exclusion criteria: * consumed probiotics within 30 days before enrollment * consumed antibiotics within 90 days prior to enrollment * known hypersensitivity to omadacycline or tetracycline-class antibiotics * pregnant or breastfeeding * in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study * previously participated in the study

Keywords: gut microbiome clostridioides difficile
choline metabolites in people with prostate cancer and those with benign hyperplasia

Conditions: Primary Prostate Urothelial Cancer; Benign Prostatic Hyperplasia

Summary: the aim of this study was to investigate plasma concentrations of one-carbon metabolites and phospholipid classes in participants with primary prostate cancer and those with benign hyperplasia. moreover, the metabolites were studied in relation to tumor grade and age.

this observational study recruited participants with primary prostate cancer (cases) and those with benign hyperplasia (controls) before the surgery. data on the outcomes of the surgery including the results of the biopsy investigation were collected. blood samples were collected before the surgery in context of routine blood investigations. blood plasma samples collected on ethylenediaminetetraacetic acid (edta) were used to measure concentrations of free choline, betaine, dimethylglycine, folate forms, s-adenosylhomocysteine, s-adenosylmethionine, homocysteine, cystathionine, and methylmalonic acid (mma). data on serum concentrations of prostate specific antigen (psa) and the tumor grade and classification (gleason score system) were collected. the associations between the plasma concentrations of the metabolites and psa or the gleason score were studied. the concentrations of the metabolic markers were compared between the cases and the controls according to the age of the participants.

Eligibility criteria:
inclusion criteria: * men participants * age \> 50 years * recently diagnosed with primary prostate cancer or benign hyperplasia exclusion criteria: * vitamin b supplementation (folic acid\> 400 µg / day; b12\> 10 µg / day; b6\> 10 mg / day) * renal failure * advanced liver disease * chronic alcohol consumption * metastases * methotrexate therapy.
interest of follicular helper lymphocytes / regulatory follicular helper lymphocytes ratio in iga nephropathy

Conditions: Glomerulonephritis, IGA

Summary: this study aims to investigate the relevance of the tfh/tfr (follicular helper t cells/ follicular regulatory t cells) ratio in patients with iga nephropathy: * to identify a differential expression of the tfh/tfr ratio in patients considered stable or progressive * to predict, at diagnosis, the clinical evolution of the disease (progressive or stable form) in the first year.


Eligibility criteria:
inclusion criteria: * iga nephropathy histologically proven on renal biopsy according to kdigo criteria, with 8 permeable glomeruli (patients diagnosed from 2009 with a minimum follow-up for their nephropathy of 5 years (arm 1) or patients diagnosed during the study (arm 2)) control patients: lupus or anca-associated vasculitis or polycystic kidney disease (arm 3) exclusion criteria: * legal incapacity or limited legal capacity * subjects with no social security coverage. * pregnancy / no effective contraceptive method

Keywords: follicular helper t cells follicular regulatory t cells
an examination of a weight loss formula on health

Conditions: Weight Loss

Summary: the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

obesity remains a problem for overall health and risk for cardiovascular disease worldwide. while dietary modification and increased levels of physical activity remain steadfast recommendations, alternative strategies related to supplementation remain an interest for the general populace and medical communities. a potential objection to the use of dietary supplements is that they often contain stimulants designed to increase metabolism. however, consumers and health practitioners alike are wary of such formulae; hence, the continued investigation of non-stimulant supplements is warranted. therefore the aim of this study is to examine a novel weight loss formula with and without common stimulants on anthropometry and indices of cardiovascular disease risk.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 25 and 34.9 exclusion criteria: * recent history of weight change (+/- 10 lbs. within the past 3 months) * uncontrolled metabolic disorders * uncontrolled cardiovascular disorders * currently taking prescription medications (birth control is allowed) * currently taking dietary supplements for weight loss * pregnant or plan to become pregnant * have an intolerance to caffeine or other natural stimulants
a phase 3 multicenter, randomized, double-blind, placebo-controlled 14-week study of ds-5565 in chinese patients with diabetic peripheral neuropathic pain

Conditions: Diabetic Peripheral Neuropathic Pain

Summary: investigate the efficacy and safety of mirogabalin in chinese participants with diabetic peripheral neuropathic pain in comparison to placebo.

the primary objective is to compare change from baseline in weekly average daily pain score (adps) at week 14 in chinese patients with diabetic peripheral neuropathic pain (dpnp) receiving mirogabalin versus placebo.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus at screening * painful distal symmetric polyneuropathy, diagnosed at least 6 months prior to screening (see procedures manual for the diagnosis of diabetic peripheral neuropathy and neurological examination for details) exclusion criteria: * hba1c (national glycohemoglobin standardization program) \> 10.0% at screening * uncontrolled blood glucose within 1 month prior to screening, at screening or randomization * other severe pain at screening or randomization, unrelated to dpn, that may confound the assessment of dpnp * neurologic disorders at screening or randomization, unrelated to dpn, that may confound the assessment of dpnp * major psychiatric disorders at screening or randomization * creatinine clearance (using the cockcroft-gault equation) \< 60 ml/min at screening
the utility of focused frailty interventions on patients with advanced heart failure

Conditions: Heart Failure

Summary: the researchers are doing this study to find out if the cardiac rehabilitation program can improve measurements of frailty and improve independence, functional abilities, and feelings about health. frailty can be measured by weakness (as measured by hand grip strength), slowness (as measured by walking speed), low level of physical activity, low energy or self-reported exhaustion, and unintentional weight loss.

participants with advanced heart failure with a new york heart association class of iii or iv symptoms within the last 3 months will be identified by either their outpatient heart failure clinic notes or inpatient cardiology notes. patients will be approached for participation if cardiac rehab is mentioned in the notes and inclusion/exclusion criteria it met. once the consent is signed, the baseline visit will be scheduled, this will be done before cardiac rehab has started. the baseline visit include frailty assessment measured by a walk time/gait speed test and handgrip strength test, and quality of life assessment measured using the kansas city cardiomyopathy questionnaire (kccq) and minnesota living with heart failure (mlhf) questionnaire. patients will then attend cardiac rehabilitation for six week program. the cardiac rehab program will be designed by the individual facility due to the variation in exercise tolerance of each patient, no universal protocol will be used. after the six weeks of cardiac rehab, up to 16 weeks post-completion, the patient will return to mayo clinic rochester to complete the frailty and quality of life assessment.

Eligibility criteria:
inclusion criteria: * advanced heart failure patients. * these include patients with current nyha class iii-iv symptoms at the current time or within the preceding three months. * outpatient heart failure clinic with mention of cardiac rehab in patient medical record in the past year or patients admitted to the hospital to any inpatient cardiology service (including the coronary care unit (ccu)) and mention of cardiac rehab from service. exclusion criteria: * unable to perform physical activities due to anatomic or musculoskeletal comorbidities * physical activity is contraindicated

Keywords: frailty advanced
evaluation of a low fluoride dentifrice for caries control

Conditions: Dental Caries

Summary: the aim of this randomized clinical trial is to evaluate the effect of ph and fluoride concentration in liquid dentifrices in the control of dental caries in early childhood, in non-fluoridated area. this study also aims to assess the effect of the consistency of liquid dentifrices in the fluoride uptake in the plaque and the fluoride concentration in the toenails, to estimate the fluoride intake from these formulations.

the study was carried out with schoolchildren living in a non-fluoridated area, with (a) or without (i) active caries lesions, were randomly allocated into 3 groups according to the ld used over 12 months: group 1 (n=39-a/38-i): 550µgf/g-ph4.5, group 2 (n=33-a/35-i) 1100µgf/g-ph7.0, group 3 (n=33-a/34-i): 550µgf/g-ph7.0.

Eligibility criteria:
inclusion criteria: * age 2 to 4 years; * not having participated in any other clinical study within 3 months prior to selection; * not having very large carious lesions or dentin sensitivity during the study; * signature of informed consent by the parents. exclusion criteria: * using orthodontic appliances

Keywords: dentifrices dental caries fluorides nails ph