Kornimate/medical-research-clean huggingface dataset:
combination of alverine-simeticone and i3.1 probiotic in ibs-d and ibs-m in mexico

Conditions: Irritable Bowel Syndrome

Summary: this randomized study evaluates the usefulness of the i31 probiotic formula, alone or in combination with alverine/simethicone, against placebo, in the treatment of diarrhea-predominant or mixed irritable bowel syndrome

irritable bowel syndrome (ibs) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. disordered bowel habits are typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention. i31 is a probiotic formula composed of strains pediococcus acidilactici cect7483 and lactobacillus plantarum cect7484 and cect7485, previously shown to improve quality of life in patients with ibs of caucasian descent. alverine/simethicone is a combination of two drugs: alverine citrate relaxes muscle cramps that occur in the intestine in conditions such as irritable bowel syndrome and diverticulosis. simethicone is an antifoam administered orally. reduces gas formation and facilitates its elimination from the digestive tract

Eligibility criteria:
inclusion criteria: * subjects attending hospital juarez de mexico with a diagnosis of diarrhea-predominant or mixed irritable bowel syndrome (ibs-d and ibs-m), according to rome-iv criteria (lacy et al. gastroenterology 2016), providing informed consent. exclusion criteria: * unexplained weight loss, blood in feces, anemia. * use of systemic antibiotics, nsaids, antipsychotic or prokinetic medication in the 3 weeks before study initiation. * pregnant or lactating women. * history of gastrointestinal cancer. * suspicion of coeliac disease, inflammatory bowel disease (ibd), endometriosis or pelvic inflammatory disease. * history of abdominal surgery within 2 years (3 months if appendectomy or herniorraphy) * bmi below 18 * known allergy to any of the components in the treatments

Keywords: probiotic antispasmodic rome-iv
infrared low-level laser therapy before intense progressive running test of high-level soccer players

Conditions: Muscle; Fatigue, Heart; Skeletal Muscle Recovery

Summary: photobiomodulation therapy (pbmt) has recently been used to alleviate postexercise muscle fatigue and enhance muscle recovery, demonstrating positive results. a previous study by the investigator's research group demonstrated the optimal dose and the optimal output power (100 mw) for an infrared wavelength (810 nm). however, the effects of optimized pbmt on performance and post-exercise recovery in high-level soccer players, to date have not been evaluated. the present research project aims to evaluate the effects of pbmt (using low-level laser therapy) applied before a progressive running test on functional, muscle damage, inflammatory and oxidative stress markers in high-level soccer players.

to achieve the proposed objective it will perform a randomized, crossover triple-blinded, placebo-controlled trial, with high-level soccer players as volunteers. twenty-two volunteers will be randomly allocated to two intervention groups: active or placebo pbmt before a progressive running test (ergospirometry test). the blood samples for biochemical analysis will be obtained before and after a progressive running test, and another outcomes (functional) will be obtained during the test. the data will be collected by a blind assessor. the statistical analysis will follow the intention-to-treat principles and data on functional analysis will be analyzed using the paired and two-tailed t-student test. data on biochemical analysis will be analyzed using two-way anova, followed by bonferroni post hoc test. the investigators will analyze: functional aspects (rates of oxygen uptake -vo2max (absolute and relative), aerobic and anaerobic threshold and time until exhaustion), muscle damage (creatine-kinase -ck and lactate dehydrogenase -ldh), inflammatory markers (il-1β, il-6 and tnf-α) and oxidative stress markers (thiobarbituric acid -tbars, catalase - cat, superoxidedismutase - sod and carbonylated proteins).

Eligibility criteria:
inclusion criteria: * high-level soccer players; * age between 18 and 35 years; * male gender; * minimum of 80% participation in team practice sessions; * agreement to participate through signed statement of informed consent. exclusion criteria: * history of musculoskeletal injury to hips or knees in previous 2 months; * use of pharmacological agents or nutritional supplements; * smokers and alcoholics; * occurrence of musculoskeletal injury during the trial; * any change in practice routine in relation to rest of the team during the trial.

Keywords: photobiomodulation therapy low-level laser therapy performance skeletal muscle recovery high-level soccer players intense progressive running test
effects of mediyoga in patients with paroxysmal atrial fibrillation-mypaf

Conditions: Paroxysmal Atrial Fibrillation

Summary: the main purpose of this study is to investigate effect of medi yoga on quality of life, biomedical factors and health care consumption, and to study gender differences between individuals diagnosed with paroxysmal atrial fibrillation (paf). furthermore, an additional purpose is to describe people's experiences of medi yoga and identify how medi yoga affects their condition. hypothesis individuals with paf exercising medi yoga improve their quality of life and blood pressure, heart rate and heart rate variability. biological markers such as nt-probnp and crp are positively affected, and that individuals seek less medical care.

methods / materials the chosen study design is a randomized three arms controlled trial. the study will be conducted at the cardiology clinic at danderyd hospital in stockholm. one hundred and thirty two individuals will be included and randomized to the intervention group (yoga), music relaxation group or control group (usual follow-up). inclusion criteria are the diagnosis of paf and experience of symptomatic atrial fibrillation verified by ecg in the last six months. exclusion criteria are language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be able to perform yoga. individuals with persistent or permanent atrial fibrillation are also excluded. the subjects in the intervention group will practice yoga in groups for one hour once a week for 12 weeks in the hospital, with the guidance of a trained yoga instructor. they will receive written instructions on yoga exercises and a cd record to perform the yoga program at home. added to that, the standard treatment i.e. drugs, cardioversion or ablation. the music relaxation group will listen to music in half an hour in a group at the hospital.the control group receives usual care. participants are followed for three months and the evaluation is done at baseline and after three months. during these visits quality of life will be measured with two surveys, as well as variables such as blood pressure, heart rate, biological markers (crp , bnp) , and ecg and 24-hour ecg . primary endpoint: quality of life. in order to obtain a five -point difference in the quality of life, 132 subjects are required to achieve a power of 80 percent (p-value 0.05), including a loss rate of 20 percent. the calculation is based on the results of substudy i. analytical methods that will be used are: multivariate analyzes eg logistic regression, manova, etc. and univariate analyzes.

Eligibility criteria:
inclusion criteria: * diagnosis of paf and experience of symptomatic atrial fibrillation verified by ecg in the last six months exclusion criteria: * language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be able to perform yoga. individuals with persistent or permanent atrial fibrillation are also excluded.
a double-blind, controlled study of aripiprazole in co-morbid schizophrenia and cocaine dependence

Conditions: Schizophrenia; Cocaine Dependence

Summary: the purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. since aripiprazole has established effects against schizophrenia, the study focuses on whether aripiprazole concurrently reduces co-morbid cocaine dependence in schizophrenia plus cocaine dependence sufferers compared to a standard typical antipsychotic treatment (perphenazine). the working hypothesis states that subjects in the aripiprazole treatment arm of the study will give fewer cocaine positive urine specimens as compared to the perphenazine control arm.


Eligibility criteria:
inclusion criteria: 1. have a primary dsm-iv diagnosis of schizophrenia or schizoaffective disorder 2. have a dsm-iv diagnosis of current cocaine dependence. 3. are capable of reading, comprehending, and signing informed consent. 4. agree to take aripiprazole or perphenazine as treatment for schz and cd. 5. agree to stop taking any other antipsychotic medication 6. if female and of child bearing potential (wocbp) agree to use an acceptable form of birth control and have a negative pregnancy test within 2 days prior to starting study medication exclusion criteria: 1. under 18 years old or over 65 years old. 2. refusal or inability to give informed consent, 3. have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension (dehydration, hypovolemia), 4. a history of seizures or conditions that lower the seizure threshold 5. have current suicidal ideation (history of suicide attempt in past 60 days) 6. are actively psychotic which in the opinion of the investigator would preclude proper informed consenting or protocol adherence 7. are receiving or plan to receive an agent metabolized by the cytochrome p450-3a4 or -2d6 systems, including carbamazepine, ketoconazole, quinidine, fluoxetine, and paroxetine 8. wocbp not on, or do not agree to use an acceptable form of contraception 9. known sensitivity to aripiprazole or perphenazine 10. a diagnosis of current or past tardive dyskinesia 11. pending legal charges or a court mandate for drug treatment 12. currently taking concomitant medications that have been shown to reduce cocaine use, such as disulfiram 13. clinically significant liver function abnormalities 14. currently receiving depot neuroleptics
developing a model to predict inpatient hypoglycemic episodes

Conditions: Hypoglycemic Events; Hyperglycemic Therapy

Summary: this study will create a new model to predict hypoglycemic events in diabetic inpatients on anti-hyperglycemic therapy using retrospective data with the goal of developing a model that will accurately predict hypoglycemic episodes in the patient population - piloting the risk score that was developed in the context of endotool being rolled out at the institution, to determine the feasibility and acceptability of viewing the risk score in the electronic health record

design a model to predict hypoglycemic episodes in real time, rather than retrospectively identifying high risk patients who experienced a hypoglycemic event at some point during their hospitalization, as has been done prior. potential predictors of hypoglycemia identified in prior work and additional predictors identified by the clinical team to develop a discrete-time multinomial logistic regression model to predict hypoglycemic events in real time. the risk score then will be piloted in the context of our institution's endotool subcutaneous implementation determine the feasibility and acceptability of viewing the risk score in the electronic health record

Eligibility criteria:
inclusion criteria: * providers taking care of adult patients (18 years and older) on the selected medical floors who are receiving anti-hyperglycemic medications on the chosen services (endotool and risk score implementation) and comparison groups (one group with endotool implementation and the other group without endotool implementation) exclusion criteria: * providers not on the chosen services

Keywords: diabetes hypoglycemia
immunoadsorption, dexamethasone pulse therapy and rituximab for pemphigus

Conditions: Pemphigus

Summary: pemphigus is a severe autoimmune blistering disease mediated by circulating antibodies against certain proteins important for maintaining skin integrity. protein a immunoadsorption is a dialysis-like technique selectively removing the antibodies from patient's blood. rituximab is a synthetic antibody capable of destroying b cells. b cells are responsible for production of antibodies in the patients blood that, in turn, lead to clinical signs of pemphigus. dexamethasone pulse therapy is a high-dose short-term corticosteroid therapy that may be used to suppress autoantibody production in pemphigus. while each of these three therapies had been used to treat pemphigus, none was shown effective in all cases. the hypothesis of this study is that a combination of protein a immunoadsorption, rituximab and dexamethasone is more effective that either of these treatments alone in achieving a rapid and durable improvement or cure in patients with pemphigus.


Eligibility criteria:
inclusion criteria: * diagnosis of pemphigus confirmed by immunofluorescence and desmoglein elisa. * severe disease or past treatment(s) not effective or past treatment(s) not tolerated. exclusion criteria: * general condition too poor to tolerate immunoadsorption treatment. * severe dementia or psychiatric disease.

Keywords: pemphigus rituximab immunoadsorption dexamethasone treatment management
a study of bgm0504 in healthy participants and participants with impaired renal function

Conditions: Type 2 Diabetes Mellitus (T2DM); Overweight or Obese

Summary: the purpose of this study is to assess how fast bgm0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.


Eligibility criteria:
inclusion criteria: * √ age 18-65 years on the date of signing informed consent (inclusive); * body mass index (bmi) within the range of 19.0-30.0 kg/m2 (inclusive);. * stable renal function, assessed by two egfr during screening (apart at least 3 days); * diagnosed as stable, chronic renal disease for at least 3 months. * renal function, assessed by estimated glomerular filtration rate at screening (egfr): 1. normal renal function: 90-129 ml/min (inclusive); 2. mild impairment: 60-89 ml/min (inclusive); 3. moderate impairment: 30-59 ml/min (inclusive); 4. severe impairment: 15-29 ml/min (inclusive); exclusion criteria: * ● allergic constitution includes severe drug allergy or history of drug allergy; * have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2; have a history or presence of pancreatitis; * participants in clinical trials of any drug or medical device in the 3 months prior to screening;. * suspected or confirmed history of alcohol or drug abuse; * hepatitis b surface antigen (hbsag), hiv antibody detection, hepatitis c virus antibody (hcvab), treponema pallidum specific antibody detection, positive; * donation or loss of 200 ml or more of blood within 3 months prior to screening, or blood donation during screening or within 1 months after the end of the trial; * pregnant or breast-feeding women; * the investigator considers that the participant has any other factors that would make it inappropriate to participate in this study.
use of stable carbon and nitrogen isotopes to improve dietary assessment for cardiovascular disease

Conditions: Healthy Adults

Summary: in this research study, the investigators will use a novel approach to measure what people eat. the goal is to find out whether stable isotopes that can be measured in blood, hair, and fingernails are better at measuring what people eat than the surveys that are currently used. to meet the goal, the investigators will do three things. first, the investigators will feed study participants known amounts of foods and nutrients. second, after study participants have eaten the food, the investigators will measure stable isotopes in samples of study participants' blood, hair, and fingernails. third, the investigators will determine how well these samples reflect what was eaten. the investigators will also give surveys to study participants to determine how well the surveys reflect what was eaten. this will allow the investigators to do a relative comparison of the measurements from isotopes and surveys.

this is a controlled feeding study in which the relative validity of stable carbon and nitrogen isotope ratio analysis as a biomarker of dietary intake is compared to controlled feedings and multiple 24-hour recalls. participants will be randomly assigned to a sequence of diets to be fed on four occasions. participants will undergo 24 hours of controlled feeding on four non-consecutive days over a month-long period. on the day after feeding, participants will complete 24-hour dietary recalls, and provide blood, hair, and fingernail samples for isotope ratio analyses. the investigators will use a crossover design and the diets will be either high or low in c4 plants (i.e., corn and cane products). a 24-hour urine collection will be done at home during each 24-hour feeding period. participants will have height and weight measured at the screening visit. weight will also be measured at each study visit. additionally, data will be collected via questionnaires administered at each study visit.

Eligibility criteria:
inclusion criteria: * men and women; * aged 21 and 74 years; * no history of chronic disease and in general good health; * able to provide primary study outcome; and * willing to tolerate study diets designed for controlled feeding. exclusion criteria: * recent dietary changes, restrictions, allergies or preferences; * health conditions that require management beyond the scope of the study (e.g. heart failure, kidney disease, liver disease, gastrointestinal disorder); * history of drug or alcohol abuse; * plans to leave the san diego area before study completion; and * lack of suitability per investigators' discretion.

Keywords: isotopes sugar diet health
effects of gut peptides on bone remodeling. ks-4-diabetes-19

Conditions: Type 2 Diabetes Mellitus

Summary: both glp-2 and gip reduce the bone resorption (measured as ctx) in healthy persons. in this study, we will investigate wether glp-2 and gip is reducing ctx in persons with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * male * age 25 to 70 years old. * type 2 diabetes. * in metformin or sulfonylureas exclusion criteria: * treatment with other antidiabetics * osteopososis or gastrointestinal disease * smoking * long term steroid treatment * weight change more than 3 kg within the last 3 months. * overweight or intestinal surgery

Keywords: type 2 diabetes mellitus bone resorption bone formation ctx p1np glp-2 gip bone turnover bone remodeling
dermacyd ph_detinlyn tangerine mix (lactic acid) - photo evaluation

Conditions: Hygiene

Summary: the purpose of this study is to demonstrate the absence of photoirritation and photosensitization potential of the product dermacyd phdetinlyn tangerine mix (lactic acid).


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years old; * phototype skin ii and iii; * integral skin test in the region; * willingness in following the study procedures and to be present in the clinic at the days and scheduled time for medical evaluations and for application of occlusion; exclusion criteria: * lactation or gestation * use of antiinflammatory and/or immunossupression drugs 15 days before the selection; * diseases which can cause immunity decrease, such as hiv, diabetes; * use of drug photosensitizer; * history of sensitivity or irritation for topic products; * active cutaneous disease which can change the study results; * history of photodermatosis active; * family or personal antecedent of cutaneous photo induced neoplasias; * presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and queratoses actinium; * intense solar exposure in the study area; * use of new drugs or cosmetics during the study;
clinical assessment of two daily wear monthly replacement soft silicone hydrogel contact lenses

Conditions: Myopia

Summary: the purpose of this study is to compare the clinical performance of total30 contact lenses with biofinity contact lenses over 30 days of daily wear.

subjects will wear two products and be expected to attend 4 office visits. the individual duration of participation will be approximately 65 days, which includes approximately 30 days of exposure to the test product and approximately 30 days of exposure to the comparator product.

Eligibility criteria:
inclusion criteria: * able to understand and sign an approved informed consent form; * willing and able to attend all scheduled study visits as required by the protocol; * currently wearing any commercial spherical weekly/monthly soft contact lenses in both eyes for at least 3 months, minimum 5 days per week, 10 hours per day; * manifest cylinder less than or equal to 0.75 diopter (d) in each eye; * willing to stop wearing habitual contact lenses for the duration of study participation. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any eye condition that contraindicates contact lens wear, as determined by the investigator; * any use of systemic or ocular medicine that contraindicates contact lens wear, as determined by the investigator; * ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study; * any use of topical ocular medications and artificial tear or rewetting drops that would require instillation during contact lens wear; * current or prior biofinity contact lens wear in the past 3 months prior to consent. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
a study testing the use of a perivascular sirolimus formulation (sirogen) in esrd patients undergoing av fistula surgery

Conditions: Complication of Renal Dialysis; End Stage Renal Disease; End Stage Kidney Disease; ESRD; Chronic Kidney Failure; Complication of Hemodialysis; Vascular Access Complication; Arteriovenous Fistula

Summary: the primary study objective is to evaluate the benefit of the sirolimus eluting collagen implant (seci; sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.

this is a phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the sirolimus-eluting collagen implant (seci) in subjects who are on hemodialysis and are undergoing surgical creation of an av fistula in comparison to subjects who do not receive the implant. subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. subjects who meet eligibility criteria and undergo successful av fistula creation will be eligible for enrollment. the study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.

Eligibility criteria:
inclusion criteria: * age 65 years or older * currently on hemodialysis for ≤12 months * successful creation of a single stage radiocephalic end to side fistula exclusion criteria: * prior av access created on the limb where the fistula surgery is planned * planned start of peritoneal dialysis within 6 months of randomization * known hypersensitivity to the following: sirolimus, beef or bovine collagen * known to be hiv positive * prisoner, mentally incompetent, and/or current alcohol or drug abuser

Keywords: arteriovenous fistula hemodialysis vascular access dialysis fistula dialysis access