Kornimate/medical-research-clean huggingface dataset:
micro-nutritional status and gut microbiota in morbidly obese patients before and after gastric bypass

Conditions: Obesity; Bariatric Surgery Candidate

Summary: an intervention study design in 90 obese patients will be used. nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post surgery. during this period of 6 months, all patients will receive a specific diet according to recommendation with regard to bariatric surgery. subjects will be than randomized in 2 sub-groups: a. patients receiving a standard healthy diet without micro-nutriments' supplementation; b. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation

the primary aim of the study is to analyse the micro-nutritional status in morbidly obese patients before and 6 months after bariatric surgery (roux-en-y gastric bypass, rygb). the secondary outcome will be the impact of 6 months probiotics, minerals, aminoacids, omega-3 acids and vitamin supplementation on microbiota, metabolic and psychological parameters 12 months post-rygb. an intervention study in 90 obese patients (bmi\>40 kg/m2) will be used. nutritional, metabolic and psychological status as well as gut microbiota will be evaluated before gastric bypass and 6 months post rygb. during this period of 6 months, all patients will receive a specific diet according to recommendation with regard to rygb. subjects will be than randomized in 2 sub-groups: a. patients receiving a standard healthy diet without micro-nutriments' supplementation; b. patients receiving a healthy diet and probiotics, minerals, aminoacids, omega-3 acids vitamin and mineral supplementation healthy diet will be defined as follow: 9-15% of proteins, 50-55% of carbohydrates and 30-35% lipids (25% saturated fat, 50% mono-unsaturated fat and 25% poly-unsaturated fat). the following parameters will be analysed before rygb and 6 months and 12 months post rygb, respectively: * nutritional status with oxidative stress parameters (vitamins a and e, selenium, zinc, copper, glutathione peroxidise, superoxide dismutase and iron) * metabolic parameters (total cholesterol, ldl-cholesterol, hdl-cholesterol, triglycerides, fasting glucose and insulin, crp) * fatty acids (linoleic acid, alpha-linoleic acid (ala), eicosapentaenoic acid (epa), and docosahexaenoic acid (dha) * gut microbiota * psychological status (anxiety, depression and quality of life as evaluated by validated questionnaires).

Eligibility criteria:
inclusion criteria: * obesity bmi\>40 kg/m2 exclusion criteria: * antidepressant treatment
visual acuity after the combined binocular implantation of +2.75 diopters and +3.25 diopters tecnis multifocal intraocular lenses.

Conditions: Cataract

Summary: the objective of this study is to assess the visual outcome after the combined binocular implantation of +2.75 d and +3.25 d full-diffractive multifocal intraocular lenses.

bifocal multifocal intraocular lenses (miol) are effective in achieving good uncorrected visual acuities in the distance and the near. however, the intermediate vision is of increasing relevance for everyday's life. several multifocal intraocular lenses have been developed to improvement intermediate vision. nonetheless, those systems still possess adverse photic effects and do not garantuee spectacle independence. therefore, the combination of a lower-addition bifocal intraocular lense in the distance-dominant eye with a higher-addition bifocal intraocular lense in the fellow-eye might be a promising approach to address these drawbacks of current binocular and trifocal intraocular lenses.

Eligibility criteria:
inclusion criteria: * clinically significant cataract * endothelial cell count: patients aged 18-75 years: \> 1000 cells/mm2; patients \> 75 years: \> 750 cells/mm2 * absence of vision-limiting corneal or retinal comorbidities * capability to understand the informed consent exclusion criteria: * expected postoperative astigmatism \> 0.75 diopters * irregular astigmatism * dilated pupil diameter \< 3 mm * corneal and fundus abnormalities that might cause visual impairments * inability to attend follow-up visits

Keywords: multifocal intraocular lens binocular trifocality cataract surgery spectacle independence intermediate vision photopic vision mesopic vision scotopic vision binocular vision
addressing sexual concerns in breast cancer: patient intervention study

Conditions: Breast Cancer Female

Summary: the goal of this study is to evaluate an educational video intervention (called starting the conversation) aimed to enhance breast cancer patients' beliefs about and communication with respect to sexual concerns. in the current study, 128 breast cancer outpatients will be randomized to either participate in the video intervention and to receive a resource guide addressing sexual and menopausal health or to receive the resource guide alone. patients will be asked to participate in the video and/or read through the resource guide prior to their clinic visit with their breast cancer provider. the investigators will examine effects of the interventions on patients' beliefs about communication about sexual health and on patients' communication about sexual health during clinic visits with their providers. secondarily, the investigators will examine effects of the interventions on sexual outcomes and other health outcomes, including psychological well-being and health-related qol.


Eligibility criteria:
inclusion criteria: 1. receiving any treatment for breast cancer or have completed acute treatment for breast cancer \< 10 years ago 2. attending clinic visits in the course of follow-up care (i.e., not an initial consult visit) 3. willing to have clinic visit audio recorded exclusion criteria: 1. unable to speak english 2. eastern cooperative oncology group (ecog) performance score \> 2 or too ill to participate as judged by physician, self-report, or observation of the research team member 3. overt cognitive dysfunction or psychiatric disturbance or severe mental illness (e.g., dementia, suicidal behavior, or psychosis), as observed or judged by the researcher or referring source.

Keywords: communication sexual health menopausal health
ultra-early statin in patients with aneurysmal subarachnoid hemorrhage (ue-star)

Conditions: Subarachnoid Hemorrhage; Subarachnoid Hemorrhage, Aneurysmal; Aneurysmal Subarachnoid Hemorrhage; Hemorrhage, Aneurysmal Subarachnoid

Summary: a researcher-initiated and conducted multicenter, randomized controlled trial aimed at evaluating the efficacy and safety of ultra-early statin therapy in the treatment of acute aneurysmal subarachnoid hemorrhage (asah).

to further explore the efficacy and safety of ultra-early statin administration in asah, the investigators propose a phase iii randomized controlled trial-the ultra-early statin in patients with aneurysmal subarachnoid hemorrhage (ue-star) trial. this study aims to determine whether ultra-early (within 6 hours), short-term treatment (2 weeks) with a high intensive long-acting statin (atorvastatin 40 mg/day) improves clinical outcomes at 6 months in asah patients. through this research, the investigators hope to provide more robust evidence for the clinical management of asah, ultimately improving treatment outcomes for patients.

Eligibility criteria:
inclusion criteria: 1. male or female; aged ≥18 years 2. signs and symptoms presumed aneurysmal subarachnoid hemorrhage, confirmed by radiological evidence 3. treatment within 6 h after symptom onset exclusion criteria: 1. treatment with statin prior sah 2. non-asah (e.g. traumatic subarachnoid hemorrhage, arteriovenous malformation) 3. treatment \&gt; 6 h after symptom onset 4. allergy to statin medications or presence of severe adverse reactions such as abnormal liver function or rhabdomyolysis 5. evidence of irreversible brain damage or expected death within 7 days 6. known severe liver or kidney disease 7. non-compliance with follow-up 8. pregnant or breastfeeding 9. history of severe cranial or psychiatric illness 10. concomitant serious systemic disease 11. patients with malignant tumors 12. currently participating in another clinical trial 13. considered unsuitable for the clinical trial by clinical physicians or researchers

Keywords: aneurysmal subarachnoid hemorrhage atorvastatin atorvastatin calcium
study evaluating the safety and efficacy of bazedoxifene in postmenopausal asian women

Conditions: Postmenopause; Osteoporosis

Summary: the purpose of this study is to evaluate the effect of 20 mg of bazedoxifene in comparison to placebo on bone mineral density after 6 months of therapy in a population of postmenopausal asian women.


Eligibility criteria:
inclusion criteria: 1. generally healthy asian women 45 years of age or older who are at least 1 year postmenopausal 2. subjects must qualify for one of the following categories (a or b): 1. greater than 1 year but less than 5 years postmenopausal with at least one of the ospeoporosis risk factors 2. equal or greater than 5 years postmenopausal with bmd t-score at lumbar spine or femoral neck between -1 and -2.5 (values of -1 and -2.5 are acceptable) with at least one osteoporosis risk factor exclusion criteria: 1. one (1) or more osteoporotic vertebral fractures (t4 - l4) 2. bmd t-score at the lumbar spine or femoral neck less than -2.5 3. past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis

Keywords: postmenopausal women serm osteoporosis
gallant 2 tesaglitazar vs. placebo

Conditions: Type 2 Diabetes

Summary: this is a 24-week randomized, double-blind, parallel-group, multi-center, placebo-controlled study of tesaglitazar (0.5 and 1 mg) in patients with type 2 diabetes, not adequately controlled on diet and lifestyle advice alone during the run-in period. the study comprises a 6-week single-blind placebo run-in period followed by 24-week treatment period and a 3-week follow-up period. the study design of gallant 2 is identical to gallant 22; the blinded study data from gallant 2 will be transferred to the gallant 22 database and will be analyzed together with the data from gallant 22 clinical study.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are \>=18 years of age * female patients: postmenopausal, hysterectomized, or if of childbearing potential, using a reliable method of birth control * diagnosed with type 2 diabetes * treated with diet alone or treatment with a single oral antidiabetic agent or low doses of two oral antidiabetic agents * drug-naïve (ie, no use of antidiabetic drug\[s\] for at least 24 weeks prior to visit 1). exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, neutropenia (low white blood cells) * creatinine levels above twice the normal range * creatine kinase above 3 times the upper limit of normal * received any investigational product in other clinical studies within 12 weeks * any clinically significant abnormality identified on physical examination, laboratory tests or electrocardiogram, which in the judgment of the investigator would compromise the patient's safety or successful participation in the clinical study
study of autologous car-t cells targeting b7-h3 in tnbc ic9-car.b7-h3 t cells

Conditions: Breast Cancer; Relapse; Resistant Cancer; Triple Negative Breast Cancer

Summary: this phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor t cells (car-t) cells in subjects with relapsed/refractory triple-negative breast cancer (tnbc).

t lymphocyte chimeric antigen receptor cells against the b7-h3 antigen (ic9-car.b7-h3 t cells) treatment is experimental and has not been approved by the food and drug administration. the safety of ic9-car.b7-h3 t cells will be investigated using a modified 3+3 design. the data from the dose escalation will be used to determine a recommended phase 2 dose (rp2d), which will be decided based on the maximum tolerated dose (mtd) and additional factors such as the ability to manufacture sufficient cells for infusion. subjects with tnbc who meet procurement eligibility criteria will have cells collected to manufacture ic9-car.b7-h3 t cells. eligible subjects will receive lymphodepletion with cyclophosphamide and fludarabine.

Eligibility criteria:
inclusion criteria: unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study: 1. written informed consent and health insurance portability and accountability act (hipaa) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative. 2. age ≥ 18 years at the time of consent. 3. karnofsky score of \> 60% (see appendix vi- karnofsky scale)) 4. histologically confirmed tnbc (er-, pr-, her2-negative) 1. er- and pr-negative: defined as \< 1% staining by immunohistochemistry (ihc) 2. her2-negative: defined as ihc 0-1+ or fluorescence in situ hybridization (fish) ratio \< 2.0 exclusion criteria: 1. patients with a history of symptomatic cns involvement or multiple metastases requiring whole-brain radiation. 2. subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 3. subject does not have a measurable and or evaluable disease as defined by recist 1.1

Keywords: cellular therapy biologic therapy
a study of tcd601 (siplizumab) in newly diagnosed adult amyotrophic lateral sclerosis (als) patients

Conditions: ALS

Summary: the purpose of this study is to investigate the safety, pharmacokinetics (pk), and pharmacodynamics (pd) of tcd601 (siplizumab) in newly diagnosed adult als patients.


Eligibility criteria:
key inclusion criteria: * male or female patients ≥ 18 to 80 years of age. * diagnosis of als by revised el escorial criteria, at study entry within 24 months of first symptoms. * patients on existing als treatment must have been on a stable dose for 28 days. key exclusion criteria: * patient with severe systemic infections, current or within the two weeks prior to randomization. * subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol. * use of other investigational products or treatment in another investigational drug study within 30 days of screening * pregnant or nursing (lactating) women.

Keywords: amyotrophic lateral sclerosis neuroinflammatory
prognostic value of neutrophil-to-lymphocyte ratio (nlr) on rectal cancer patients

Conditions: Rectal Cancer; Prognosis

Summary: we explored the relationship between nlr and grade 3 or higher treatment related small bowel toxicity and treatment outcome of patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy (imrt).

gender, age, stage of disease, and pathologic factors were retrospectively obtained from electronic patient records. staging was determined according to the classification established by the american joint committee on cancer (ajcc, 7th edition).pelvic magnetic resonance imaging (mri) were used for pretreatment staging. all patients enrolled in this study were treated with intensity modulated radiotherapy (imrt) concurrent with capecitabine (1600 mg/m2/d, administered twice daily for two weeks) before or after curative resection. the mean radiation dose was 50 gy with daily fraction of 2.0 gy. acute treatment toxicity was scored according to the national cancer institute common terminology criteria for adverse events (ctcae; version 3.0) and late toxicity was classified according to the late effects in normal tissue-subjective, objective, management and analytic (lent-soma) system. after the whole treatment procedure, all patients were subjected to a follow-up every three months for the first two years, every six months for the next three years, and every year thereafter. physical examinations, routine blood test, serum carcinoembryonic antigen (cea) and cancer antigen 19-9 (ca-199) level were checked at each follow up. chest, abdominal ct scan and total colonoscopy were performed annually except the suspicion of tumor recurrence. overall survival (os) time was defined from the date of completion of treatment to death from any cause and progression-free survival (pfs) time was defined as the time from the date of completion of therapy to the date of local recurrence or distant metastasis or death. patient follow-up was lasted until death or the cutoff date of january 2017.blood sampling reports from each enrolled patient were obtained within seven days before treatment. white blood cell count, neutrophil, lymphocyte and platelet counts were examined. the nlr was calculated as the absolute neutrophil count divided by the absolute lymphocyte count using baseline blood test results.

Eligibility criteria:
inclusion criteria: * patients with locally advanced rectal cancer who received neoadjuvant or adjuvant chemoradiotherapy at our hospital were enrolled in this study. exclusion criteria: * patients with coexistent autoimmune diseases, infectious diseases, and lacking baseline blood test records were excluded from this study
the effect of mindfulness/meditation on post-operative pain and opioid consumption

Conditions: Rotator Cuff Tears

Summary: the objective of this study is to examine the effectiveness of mindfulness/meditation using the headspace app on post-operative pain and opioid consumption in patients after arthroscopic rotator cuff repairs, biceps tenodesis, and mumford procedures.

the purpose of this study is to examine the effectiveness of mindfulness/meditation on post-operative pain and opioid consumption. patients will be randomized into one of two standardized groups after shoulder arthroscopy: control group (con) and mindfulness/meditation group (mm). all participants will be consented and enrolled into the study before surgery. both groups will receive the same standardized method of post-operative pain medication for post-operative pain relief. participants in the mm group will utilize a headspace application on their smart phone meditate twice a day while the control group will not perform any meditation or mindfulness. patient reported outcomes will be collected at regular intervals. patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis and/or mumford procedure. the study includes 3 visits which are standard of care pre-operative and post-operative visits. the duration of the study will be 6 months which will include 3 standard of care post-operative visits and electronic surveys to track patient reported outcome.

Eligibility criteria:
inclusion criteria: * 18 years and older * status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or mumford procedure exclusion criteria: * less than 18 years old * patients undergoing a simultaneous arthroscopic procedure that is not in the inclusion criteria. * history of shoulder osteoarthritis

Keywords: shoulder arthroscopy head space mindfulness subacromial bursitis biceps tenodesis
chronic urinary retention in elderly living in homes for the aged : benefits of bladder scan screening

Conditions: Urinary Retention

Summary: the goal of this cross-sectional, multicentric and descriptive epidemiological study is to assess the prevalence of chronic urinary retention (cur) in elderly living in residential care for dependent elderly people in order to determine if there is an interest in offering them a bladder scan screening.

the main goal of this study is to assess the prevalence of cur in elderly living in homes for the aged, the secondary ones are to evaluate the risk factors and complications of cur. we will carry out this prevalence study in 5 centres whit a draw of 40 residents per centre. following an information and a non-opposition of the patients, we will collect datas in their medical file (age, medical history and comorbidities, current treatments, anticholinergic score according to the ads (anticholinergic drug scale), gir score according to the aggir scale (autonomie gérontologique groupes iso ressources), fac modified score (functional ambulation classification modified), mmse score (mini mental state examination), communicative capacity, notion of fall and date of last fall, knowledge of urinary incontinence, knowledge of constipation, knowledge of previous urinary screening by bladder scan and previous urological consulting, last urinalysis and its results, last analysis of creatinemia and creatinine clearance according to ckd-epi) and we will perform up to 3 measurements of vesical volume by bladder scan. the expected results are a prevalence of cur between 10 and 20 % among people living in homes for the aged with more urinary tract infections, renal insufficiency and falls in the cur group showing the interest of screening for cur by bladder scan in elderly people living in nursing homes according to risk groups based on the risk factors found.

Eligibility criteria:
inclusion criteria: * adult people * residents in a participating nursing home exclusion criteria: * resident with indwelling urinary catheter or regular urinary catheterisation * resident or legal representative opposing participation

Keywords: urinary retention chronic disease aged homes for the aged
facilitating physical activity behavior and health outcomes in breast cancer patients receiving chemotherapy

Conditions: Breast Cancer

Summary: breast cancer and its treatments can take a toll on the physical and psychosocial well-being of cancer survivors. few interventions can help breast cancer patients improve their physical strength, stamina, and overall well-being. developing ways to facilitate pa behavior during chemotherapy for breast cancer are necessary. this trial explores ways that breast cancer patients receiving chemotherapy can learn about and engage in pa during chemotherapy. this trial will also give southern alberta breast cancer survivors an opportunity to participate in evidence-based programs designed to facilitate their health, breast cancer recovery, and disease-free survival. the investigators primary hypothesis is that women receiving the pa intervention resource kit will report a more positive change in self-reported pa at the end of chemotherapy treatments when compared to the group receiving standard materials.

primary objective: to compare the effects of an evidence-based intervention consisting of targeted breast-cancer specific pa print materials (i.e., exercise for health), a step pedometer, a step-walking guidebook (i.e., step into survivorship), and a physical activity and step journal (int) to a comparison group receiving a generic, two-page public health pa resource (standard material: sm).

Eligibility criteria:
inclusion criteria: * are diagnosed with stage i -iiia breast cancer * are scheduled to receive neoadjuvant or adjuvant chemotherapy * did not receive transabdominal rectus abdominus muscle (tram) reconstructive surgery * are \>18 years of age * receive approval from their treating oncologist to participate * do not have uncontrolled hypertension, cardiac illness, or psychiatric conditions (i.e., indicated in patient medical charts).

Keywords: breast cancer physical activity quality of life theory of planned behavior behavior change health promotion