Kornimate/medical-research-clean huggingface dataset:
effect of synbiotic supplement on the body mass index of participants with severe obesity

Conditions: Obesity Class III

Summary: obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function. potential mediators of intestinal microbiota are prebiotics, supplements considered safe because they are naturally contained in food and human microbiota. probiotics are living bacteria which are found in the normal gut microbiota. synbiotics are combinations of both prebiotics and probiotics. their use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including severe obesity. this is a double-blind, placebo-controlled, randomized clinical trial to assess the effect of synbiotic supplementation (fructo-oligosaccharide and probiotic - 12 g / day) on body mass index in participants with obesity class iii, with follow up of 90 days.

obesity has been discussed as one of the major diseases that require scientific and technological innovations for its control is obesity and studies indicate that microbiota of obese patients have a high level of intestinal microflora imbalance, with serious consequences such as loss of digestive function and the combination of toxins to protein. potential mediators of intestinal microbiota are prebiotics, probiotics and synbiotics, supplements considered safe because they are naturally contained in food and human microbiota. its use has been studied as a new therapeutic approach for the regulation of intestinal microbiota in various situations of disease, including in severe obesity. this study aims to analyze the effect of synbiotics supplementation on body mass index in participants diagnosed with morbid obesity. the methodology used is the randomized clinical trial, placebo-controlled with blinding of patients, healthcare staff and outcome assessors, with follow-up of 90 days. patients will be randomized into two groups: control group to receive placebo (polydextrose - 12 g / day) and synbiotic group - group supplemented with synbiotic (fructo-oligosaccharide and probiotics - 12 g / day). probiotics are: lactobacillus acidophilus; lactobacillus rhamnosus; lactobacillus paracasei; bifïdobacterium lactis. at the moments proposed in this study, will be conducted assessments of food intake, nutritional status and metabolic / inflammatory parameters (body mass index, high-sensitivity c-reactive protein, albumin, triglycerides, total cholesterol, hdl-cholesterol and ldl-cholesterol, fasting blood glucose, glycated hemoglobin, fasting insulin, weight, height).

Eligibility criteria:
inclusion criteria: * obesity class iii (body mass index ≥40kg/m2) exclusion criteria: * current use of prebiotics and probiotics or use in the last three months * intolerance to prebiotics and probiotics

Keywords: synbiotic obesity body mass index microbiota
prospective pakistan registry of echocardiographic screening in asymptomatic pregnant women

Conditions: Cardiovascular Diseases in Pregnancy

Summary: consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. a standardized 2d transthoracic echocardiogram (tte) protocol was employed. ejection fraction (ef) was quantified using biplane simpson's method.

consecutive obstetric patients attending routine antenatal visits were enrolled in this ongoing registry. a standardized 2d transthoracic echocardiogram (tte) protocol was employed, including parasternal long and short, apical 4- and 2-chamber views. continuous wave and pulse wave doppler were used to assess left ventricular outflow tract (lvot) gradients. left ventricular (lv) function was quantified using biplane simpson's method and visually assessed by two independent readers. patients with significant valve disease or congenital heart disease underwent complete tte. those diagnosed with lv dysfunction or other cardiovascular diseases (cvd) were referred to the cardio-obstetrics clinic for further management and long-term follow-up.

Eligibility criteria:
inclusion criteria: * obstetric patients attending routine antenatal visits exclusion criteria: * patients refused to give consent for echocardiography or participation in the study
safety and efficacy active drug vs. placebo in subjects with asthma

Conditions: Asthma

Summary: this study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.


Eligibility criteria:
inclusion criteria: * subjects with asthma exclusion criteria: -

Keywords: allergy asthma
more - monitoring revlimid - collecting of patient information from myelodysplastic syndrome (mds) italian national registry

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk myelodysplastic syndrome (mds) associated by deletion 5q who were prescribed revlimid from 31october 2008 to present. revlimid is available in italy for these patients since october 2008 based on a local disposition of the italian drug agency (aifa) issued according to a national law named 648/96.

there will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.

Eligibility criteria:
inclusion criteria: * intermediate 1 and low risk mds patients associated with: 1. transfusion dependency anemia (at least 2 units per 8 weeks before starting of revlimid treatment ) 2. 5q31-33 deletion isolated or associated to other chromosomal abnormalities. exclusion criteria: * patients with serum creatinine \> 2.5mg/dl * child bearing potential females who do not use adequate contraceptive methods

Keywords: more monitoring revlimid myelodysplastic syndrome transfusion-dependent anemia 5q deletion lenalidomide
long-term nutritional intervention study to determine how protein affects calcium metabolism

Conditions: Osteoporosis

Summary: osteoporosis is a major health problem in men and women in this country and the incidence of this disease is rising. we think that environmental factors such as nutrition may play a role in the increasing prevalence of osteoporosis. in particular, we think that a diet that is too low in protein may be contributing to bone loss. the primary purpose of this study is to compare the long-term impact of a low protein diet on measures of bone and calcium metabolism.

the protocol is composed of a 9.5-week study, consisting of a 3-week adjustment period followed by a 6.5-week experimental period. during the adjustment period, subjects consume a well-balanced lead-in diet designed to stabilize baseline ca homeostasis. in the subsequent experimental period, subjects will consume the experimental diet containing 0.7 g protein/kg, 800-1200 mg phosphorus, 800 mg calcium and 2300 mg sodium. during days -6 to -1 of the adjustment diet, 5-10 and days 40-45 of the experimental period, we will measure ca absorption and kinetics. weekly assessments of ca homeostasis will be done using our standard measures of calcitropic hormones, markers of bone turnover, and urine and serum minerals.

Eligibility criteria:
inclusion criteria: * healthy asian or caucasian women between the ages of 20-40 years. exclusion criteria: * diseases or medical conditions: gastrointestinal diseases, osteoporosis, diabetes, hypertension, liver disease, thyroid disorders, kidney disease, kidney stones, cancer, heart disease, eating disorders, obesity, hypogonadism , amenorrhea, oligomenorrhea, abnormal serum fsh or estradiol levels, birth control medication, or other hormone-altering medications, pregnancy. * lifestyle: smoking, excessive exercise (although moderate exercise is allowed), prescription medications known to influence vitamin d or calcium metabolism or gastric acid, excessive body weight change during the past 6 months, food allergies, unusual eating habits, or medically prescribed diets. * also excluded are prisoners and individuals who are cognitively impaired.

Keywords: protein calcium parathyroid hormone bone markers calcium kinetics absorption
lipid lowering effect of plant stanol ester in a spoonable non-dairy product

Conditions: Hypercholesterolemia

Summary: the aim is to determine the effect of investigational products on serum ldl cholesterol.


Eligibility criteria:
inclusion criteria: * signed written informed consent * mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l) * plasma triglyceride levels ≤ 4.0 mmol/l * age 18-65 years exclusion criteria: * intolerance to oats or other ingredients of the test products * severe obesity (bmi ≥ 32 kg/m2) * consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, pcsk9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. statin treatment is allowed at stable dose. * consumption of plant stanol or plant sterol containing food products or supplements such as benecol, becel pro.active, keiju alentaja or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample) * history of malignant diseases like cancer within five years prior to recruitment * history of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (cabg), percutaneous transluminal coronary angioplasty (ptca) within the previous 6 months * diagnosed type 1 or type 2 diabetes requiring medical treatment * celiac disease * medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. orlistat, victoza) * alcohol abuse (\> 4 portion/per day) or recreational drug abuse * pregnancy or planned pregnancy or lactating * clinically significant abnormalities in screening labs * participation in another clinical trial in the preceding 3 months
effect of periorbital massage on dry eye disease

Conditions: Dry Eye

Summary: this randomized controlled trial aims to investigate the efficacy of periorbital massage therapy in alleviating symptoms and improving clinical outcomes in patients diagnosed with dry eye disease.

participants will be randomized into either a periorbital massage intervention group or a control group receiving standard care. the intervention group will receive gentle periorbital massage techniques, while the control group will receive conventional dry eye treatments. the primary outcome measure will be assessed using the schirmer strips and ocular surface disease index (osdi) questionnaire. this study holds promise for providing insights into the potential benefits of periorbital massage therapy as a complementary approach for managing dry eye disease symptoms and enhancing patients' overall quality of life.

Eligibility criteria:
inclusion criteria: * symptoms of dry eye (such as burning, dryness or foreign body sensation) * ocular signs of dry eye (such as tear film instability, reduced tear production or meibomian gland dysfunction) * patients having moderate and severe dry eye disease according to schirmer test willing and able to comply with the study protocol exclusion criteria: * active ocular infection * ocular surgery within past 3 months * use of contact lenses * use of systemic medications that can affect tear production or tear quality * pregnancy or lactation
effect of short term atorvastatin treatment,80mg/day on early regression of carotid artery atherosclerotic lesions

Conditions: Atherosclerosis

Summary: atherosclerosis is a disease in which the blood vessels become blocked by plaques (consisting of fat, calcification, and fibrous tissue), reducing blood flow to vital organs and tissues.blockage of the carotid arteries in the neck is a major cause of stroke. one way of treating carotid atherosclerosis is with cholesterol-lowering drugs called statins. statins have been shown to reduce the risk of coronary heart disease by 24-40% and risk pf stroke by 11-30%.the purpose of this study is to determine if short term treatment with atorvastatin causes early favorable changes in the plaques that block blood flow through the carotid arteries. these changes can be assessed 1) by taking pictures of the carotid arteries with mri and ultrasound before and after statin treatment, and 2) by special studies of the plaques removed from the carotid arteries by surgery.

candidates for bilateral carotid endarterectomy (cea) who meet study criteria will provide informed consent before their randomization. before the first cea, the patient will have mri, us, and ebct exams of both carotids. the most occlusive plaque will be resected at the first cea. the patient will then receive atorvastatin 80 mg/day for 3 months. then the second cea will be performed. six weeks after the second cea, the patient will have another mri, us, and ebct exam and at 6, 12, and 18 months thereafter. this protocol will allow comparison of the characteristics of the plaque that has been exposed to drug vs the plaque that has not been exposed. it will also allow monitoring the effect of drug on restenosis after surgery.

Eligibility criteria:
inclusion criteria: * men or women * \>18 yrs old * expected to have an endarterectomy on each carotid artery * no contraindications for atorvastatin * stable cardiovascular health * lipid lowering treatment less than 6 mo duration * diabetic included if diabetes is controlled * patient is not claustrophobic * patient has evaluable carotid plaques. exclusion criteria: * patient has had previous carotid endarterectomy,stenting, or other procedure * unstable cardiovascular status * hypersensitivity to statin therapy * neck anatomy preventing acquiring bilateral evaluable plaques * weight over 285 lbs.

Keywords: atherogenesis atheroma arteriosclerosis
outcomes of bilateral implantation of an enhanced monofocal intraocular lens

Conditions: Cataract

Summary: to evaluate and compare the visual outcomes of an enhanced monofocal intraocular lens (iol) with two different monofocal iols in patients scheduled for bilateral cataract surgery.

the main objective of the study is the evaluation and comparison of the clinical outcomes of three parallel groups of patients after bilateral implantation of icb00 iol or zcb00 iol or cna0t0 iol respectively. the icb00 iol is a modified monofocal iol. compared to other monofocal iols, its modified optical design was created to provide improved intermediate vision, comparable distance vision and a profile of dysphotopsia similar to other monofocal lenses. considering the modified optical profile of the icb00 iol, the primary objective will be the evaluation of visual performance at intermediate distance.

Eligibility criteria:
inclusion criteria: * clinically significant bilateral cataract (bcva \<20/40, cataract must be the primary cause of visual impairment) * axial length between 21 and 27 mm * the patient must be able to read, understand and provide written informed consent, * the patient must be willing and able to comply with all study and follow-up procedures * preoperative refractive cylinder ≤ 0.75 d exclusion criteria: * anterior segment pathology that could significantly affect results (e.g., chronic uveitis, iritis, corneal dystrophy, keratoconus) * diabetic retinopathy * uncontrolled glaucoma and/or intraocular pressure iop\> 24 mmhg * all types of infections (acute eye disease, external/internal infection, systemic infection) * traumatic cataract * pupillary abnormalities including aniridia and/or pupil diameter in mesopic conditions in distance vision ≤ 2.5 mm and ≥ 6 mm * microphthalmia * amblyopia * degenerative visual disorders (for example macular degeneration, optic nerve atrophy or retinal disorders) * previous intraocular and corneal surgery * systemic or ocular pharmacotherapy, which may impact visual acuity and/or cause floppy iris syndrome and/or insufficient dilation in the opinion of the investigator * patients who are unable to fixate for a prolonged time (e.g. strabismus, nystagmus) * period of pregnancy or breastfeeding for female patients

Keywords: iol intermediate distance cataract surgery enhanced monofocal
efficacy and safety of amlodipine and losartan in patients with essential hypertension

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the safety and efficacy of fixed combination of amlodipine(5mg or 10mg) and losartan (50 mg or 100 mg), amlodipine and losartan alone in reducing blood pressure. the study will investigate the dose response relationship for the combinations and monotherapies.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75 * patients with essential hypertension {95 mmhg ≤ sitdbp\< 115 mmhg at the end of placebo run-in treatment period} exclusion criteria: * patients with mean sitsbp ≥ 200 mmhg * patients with known hypersensitivity to dihydropyridine or angiotensin ii receptor blockers * patients with secondary hypertension or suspected secondary hypertension * patients with malignant hypertension * patients who have received any medications with possible interactions with study drugs * patients with uncontrolled diabetes * patients with severe heart disease or severe cerebrovascular disease * patients with clinically significant hematological test results, renal disease (serum creatinine) or liver disease (alt or ast) * patients with a history of malignant disease * patients with a history of autoimmune disease * women with a positive pregnancy test result, breast feeding or intention of pregnancy during the trial * patients inappropriate to be included in study population due to other reasons at the discretion of the investigator

Keywords: amlodipine losartan hypertension
laparoscopic versus open appendectomy plus peritoneal lavage for acute complicated appendicitis patients with diffuse peritonitis

Conditions: Acute Complicated Appendicitis With Diffuse Peritonitis

Summary: this study aim to evaluate the efficacy and safety of laparoscopic versus open appendectomy in the treatment of acute complicated appendicitis with diffuse peritonitis.

appendicitis is defined as inflammation of the vermiform appendix and worldwide is the most common reason for emergency abdominal surgery. globally, the annual incidence is 96.5 to 100 cases per 100 000 adult population. for acute uncomplicated appendicitis, antibiotic therapy has emerged as the primary treatment, often allowing patients to avoid surgery. however, the management of acute complicated appendicitis requires careful consideration of various treatment options. complicated appendicitis, characterized by peri-appendiceal phlegmon or abscess formation, presents additional challenges and often requires a more comprehensive treatment approach. management strategies have evolved to incorporate both conservative and surgical treatments, tailored to the patient's condition. however, for acute complicated appendicitis with diffuse peritonitis, surgery is the only option. acute complicated appendicitis with diffuse peritonitis is a severe abdominal emergency that often requires prompt surgical intervention. traditionally, open appendectomy has been the standard approach. in recent years, laparoscopic appendectomy has gained popularity due to its minimally invasive nature and potential for faster recovery. despite this, the optimal surgical approach for complicated appendicitis with diffuse peritonitis remains debated, particularly regarding the risk of postoperative complications and recovery outcomes. the primary aim of this study is to compare the efficacy and safety of laparoscopic versus open appendectomy in such cases, focusing on postoperative complications, hospital stay, and other factors influencing surgical outcomes.

Eligibility criteria:
inclusion criteria: patients aged 18 or older; patients with diffuse peritonitis caused by a perforated appendix confirmed intraoperatively; patients who underwent emergency appendectomy with peritoneal lavage; patients who had postoperative pathological confirmation of acute appendicitis. - exclusion criteria: patients younger than 18 years; patients have a history of prior malignancies; patients with incomplete clinical or pathological records.

Keywords: acute appendicitis, laparoscopic appendectomy, open appendectomy peritoneal lavage, diffuse peritonitis
cannabis edibles packaging imagery experiment

Conditions: Cannabis Use

Summary: the purpose of this study is to assess differences in perceptions of product appeal, harm, and subsequent willingness to try cannabis edibles products with/without packaging imagery.

cannabis edibles are rapidly leading the legal recreational cannabis market. cannabis edibles present health harms that are not typical of smoked marijuana, including accidental overconsumption of high levels of tetrahydrocannabinol (thc) . product packaging plays an important role in influencing perceptions of a product's appeal and potential harm. this experiment will assign participants to view real cannabis edibles packaging edited with one of four images commonly found on real cannabis edibles products, and ask a series of questions to assess perceptions of product appeal and harm. one group of participants will serve as the control and will see the same cannabis edibles packaging without any imagery.

Eligibility criteria:
inclusion criteria: * us resident * aged 18-65, inclusive * up to 13% of participants will be those who identify as black/african american * up to 16% of participants will be those who identify as hispanic * approximately 50% of participants will be past year cannabis users * was not a participant on the anteceding experiment, cannabis edibles packaging descriptors experiment exclusion criteria: * does not currently reside in the united states * younger than 18 or older than 65 * does not provide information regarding history of cannabis use * otherwise eligible but demographic and/or user group quotas have been met * was a participant on the anteceding experiment, cannabis edibles packaging descriptors experiment

Keywords: tetrahydrocannabinol (thc) cannabis edibles product packaging
clinical effort against smoke exposure in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with cf and delivered in clinical settings as part of routine cf care. the ultimate goal of this effort is to reduce the exposure of children and adolescents with cf to tobacco smoke.

this is a single-center, randomized, open-label study to test the feasibility and acceptability (primary outcomes) and preliminary efficacy (secondary outcome) of a multi-component smoking-cessation intervention delivered by a tobacco treatment specialist (tts) integrated in the multidisciplinary cf care team. the intervention will be tested in a two-group design with a 2:1 allocation. participants (dyads of caregiver/cf child) will be randomized to either intervention or control group. the intervention group (n=24) will receive the multi-component intervention (intake assessment, follow-up, help with obtaining nicotine replacement therapy, and cf-specific smoke exposure education). the control group (n=12) will receive usual care plus cf-specific smoke exposure education.

Eligibility criteria:
inclusion criteria: * adult familial caregiver of a child with cf aged \<18 years * speak english * report smoking at least 1 cigarette in the previous week * not enrolled in a smoking cessation program exclusion criteria: * do not report smoking at least 1 cigarette in the previous week * currently enrolled in a smoking cessation program.

Keywords: caregivers tobacco smoke exposure