Kornimate/medical-research-clean huggingface dataset:
cardiac implantable electronic device (cied) research study

Conditions: Arrhythmias, Cardiac; Bradycardia; Tachycardia

Summary: the study is designed to collect data on cardiovascular implantable electronic device (cied) information, implant procedure details, and/or patient characteristics to support development of future cied products and procedures.

this is a data collection, non-randomized, multi-center study. the study will consist of different cohorts with each cohort being independent from another cohort. each cohort may have a distinct objective, cohort-specific subject population, procedures, and assessments. the study will follow subjects receiving routine care, who meet all of the inclusion criteria and none of the exclusion criteria.

Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years of age. 2. subject is willing and able to provide written informed consent. 3. subject is willing and able to complete the study procedures and visits for the duration of data collection requirements exclusion criteria: 1. subject is unwilling or unable to comply with study procedures as defined in the protocol. 2. subject with a medical condition that precludes the patient from participation in the opinion of the investigator. 3. subject is enrolled in another study that could confound the results of this study, without documented pre-approval from a medtronic study manager.
exenatide versus glimepiride in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: this study assesses the effects of twice-daily subcutaneous injection exenatide versus treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell function.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes mellitus. * treated with diet and exercise and a stable, maximally tolerated dose of metformin for at least 3 months prior to screening. * hba1c \>=6.5% and \<=9.0%. * body mass index (bmi) \>=25 kg/m\^2 and \<40 kg/m\^2. exclusion criteria: * participated in an interventional medical, surgical, or pharmaceutical study within 30 days prior to screening. * characteristics contraindicating metformin or glimepiride use. * receiving drugs that directly affect gastrointestinal motility. * receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy. * have used any prescription drug to promote weight loss within 3 months prior to screening. * treated for longer than 2 weeks with any of the following medications within 3 months prior to screening: \*insulin; \*thiazolidinediones; \*alpha-glucosidase inhibitors; \*sulfonylurea; \*meglitinides

Keywords: exenatide diabetes amylin lilly glimepiride
related factors of hp infection in physical examination and community population in hunan province

Conditions: Helicobacter Pylori Infection

Summary: this study intends to investigate the prevalence and risk factors of helicobacter pylori (h. pylori) infection in the population of physical examination centers and communities. the physical examination population from the health management center of the third xiangya hospital and the family-based community residents in changsha were randomly selected. the h. pylori infection was detected by carbon-13 urea breath test (13c-ubt), and the related factors of h. pylori infection were investigated by questionnaire survey. the study provides supporting evidences to implement family-base h. pylori management to curb its intrafamilial spread. the results have important clinical implications in refinement of eradication strategies and impact on public health policy formulation for related disease prevention.


Eligibility criteria:
inclusion criteria: 1. population aged 4-90 years, no requirement for gender; 2. the physical examination population from the health management center of the third xiangya hospital; 3. the family-based community residents in changsha city \[families containing two or more family members (living together for more than 10 consecutive months per year) and the family members aged 3 years and above\]; exclusion criteria: 1. people with use of antibiotics, bismuth or chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13c-ubt, or h2 receptor antagonists, ppis, p-cab or other drugs affecting h. pylori activity within the previous 2 weeks of 13c-ubt; 2. people with h. pylori treatment within the past 3 months; 3. people who fasted less than 3 hours before 13c-ubt; 4. people with other contraindications to performing 13c-ubt; 5. people living alone in a family; 6. people with incomplete questionnaire information; 7. people with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on; 8. people with mental illness and communication disorders; 9. people deemed unsuitable by the researchers to participate in this project;
doxorubicin pharmacokinetics and response in non hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: in previous studies, the investigators found that in patients with hodgkin's lymphoma (hl) treated with abvd (adriamycin, bleomycin, vinblastine and decarbazine) the absence of alopecia may predict for a poor response to treatment \[complete remission (cr) rate 79% versus 31%, p \< 0.0005, respectively\]. also, patients without alopecia had fewer episodes of either leucopenia, neutropenia, deferral of treatment courses or number of courses with dose reduction \[88% vs. 62.5%, p=0.05, for the presence of at least one of them\]. one of the explanations for this phenomenon is related to a lower systemic exposure of chemotherapeutic drugs in patients who retain their hair. there is a wide interpatient variability in the pharmacokinetic and pharmacodynamic parameters of doxorubicin systemic exposure and the degree of myelosuppression. in a pilot study on 18 patients the investigators could not find the previous association between alopecia, response to chemotherapy and bone marrow depression. however, when analyzing doxorubicin pharmacokinetics, patients who had no remission had 2 fold lower auc (area under the curve) and 3 fold lower peaks (p=0.06). the investigators' lack to approve the previous findings might be explained by the small study group.

aim of the study: to evaluate the association between response to chemotherapy, the degree of myelosuppression and the pharmacokinetics of doxorubicin in non-hodgkin's lymphoma (nhl) patients. methods: study protocol: 1. at diagnosis demographic and clinical parameters be collected (appendix 1) 2. at course 2: 1. doxorubicin will be given by 5-7 minutes infusion before the other medications (doxorubicin doses will be collected (appendix 1)) 2. blood will be sampled in course 2, at: 0 minutes 30 minutes 120 minutes 24 hours two 2ml edt tubes will be drawn at each time the tubes will be centrifuged at 3000 rpm for 15 min. plasma samples will be stored in - 700c 3. at the end of chemotherapy courses the following data will be collected (appendix 2): 1. episodes of bone marrow depression (leucopenia, neutropenia) treatment delays dose reductions neutropenic fever 2. remission status \[complete remission (cr) - disappearance of clinical signs and symptoms of nhl along with normal laboratory and radiological findings\]. 4. at the end of one year of cr remission status number of patients: 30

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * biopsy proven intermediate grade nhl * no previous chemotherapy * at least 4 courses of r-chop at maximal doses are planned * an informed consent exclusion criteria: * do not meet all inclusion criteria

Keywords: doxorubicin pharmacokinetics non-hodgkin's lymphoma response association between response to chemotherapy myelosuppression degree doxorubicin pharmacokinetics
study for identifying optimal simvastatin formulation for uniform time to maximum plasma concentration

Conditions: Celiac Disease

Summary: the inter- and intra-variability in the pharmacokinetic parameters of different formulations and doses of simvastatin in healthy subjects and in subjects with celiac disease in remission will be evaluated. additionally, baseline values of pharmacokinetic parameters of simvastatin for both study groups will be determined.


Eligibility criteria:
inclusion criteria: * if the subject is female, she is eligible to enter and participate in this study if she is physiologically incapable of becoming pregnant or has a negative urine pregnancy test at screening and at baseline visit * negative serology for hepatitis b/c, hiv * non-oatp1b1\*5 carriers * negative serology for anti-transglutaminase iga antibody, and normal levels of total iga * for subjects with celiac disease, also * diagnosis of celiac disease confirmed by medical history, histological evaluation of small intestinal mucosa on small bowel biopsy, and abnormal anti-transglutaminase antibody titers * followed a gluten-free diet for at least one year, as verified by normal anti-transglutaminase antibody levels, marsh 0-1 score on a follow-up biopsy within the past 12 months, and absence of any clinical signs or symptoms of celiac disease observed at diagnosis exclusion criteria: * current smoker or quit smoking less than 2 years ago * female breastfeeding or disagrees to use an effective mechanical contraceptive method (e.g. diaphragm or nonhormonal intrauterine device in combination with preservative) * presence of any known on-going disease which is judged to be relevant according to the investigator, besides celiac disease for the cohort of celiac patients in remission * state after operations of the stomach or bowel (exception: appendectomy) * participation in any other clinical trial with investigational or approved drugs within the last month before the study * regular alcohol consumption of more than 25 g / day * use of any prescription or non-prescription drugs (including herbal supplements) must be discontinued 30 days prior to study (exceptions: paracetamol and nsaids, not taken longer than 2 days in a row and not taken within the last 3 days before the study) * consumption of grapefruit, star fruit, grapefruit juice, or star fruit juice must be discontinued 7 days prior to the study
irritable bowel syndrome regional cohort

Conditions: Irritable Bowel Syndrome

Summary: setting up a regional (multicentre), longitudinal cohort of people suffering from irritable bowel syndrome followed up in consultation to study the natural history of the disease and its prognosis.

the strategy of this project is to develop a regional cohort of patients suffering from irritable bowel syndrome, in order to offer harmonised phenotyping, longitudinal follow-up and the study of clinical and biological factors associated with the development of the disease and its treatment. to achieve this, the study plans to prospectively collect a complete phenotyping of patients suffering from ibs and followed up in consultation in the participating centres (questioning, questionnaires, physiological explorations and results of complementary examinations), with follow-up of the course of the disease and which will be supplemented by stool samples for analyses of the microbiota and metabolites. the study aims to include all patients seen prospectively in the centres over a period of 2.5 years and to include as many stool samples as possible during follow-up visits. this should make it possible to include a total of 600 patients. this number will be sufficient to identify subgroups of patients with similar clinical or biological characteristics of reasonable size (at least 50 to 100 subjects each) and then compare their prognosis.

Eligibility criteria:
inclusion criteria: * patient * normal laboratory work-up as part of routine care (cbc, crp) * over 18 years of age * patient affiliated to a social security scheme * person who has read and understood the information letter and does not object to taking part in the study exclusion criteria: * patient suffering from an organic digestive pathology (chronic inflammatory bowel disease, microscopic colitis when endoscopy has been performed because deemed necessary, digestive cancer, coeliac disease) or major digestive surgery (excluding appendectomy and cholecystectomy). * patient refusal * patient does not speak or understand french * a pregnant woman or a woman in labour or breastfeeding * person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship
ice application for postoperative pain

Conditions: Postoperative Pain

Summary: the purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial.

the purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial. the following aims will be pursued: primary aim: to determine if cryotherapy patients will have lower pain scores on vas compared to standard pain management patients. primary hypothesis: patients receiving cryotherapy will have lower vas scores compared to patients receiving pain management. secondary aim 1: to determine if cryotherapy will reduce the number of morphine milligram equivalent (mme) compared to patients with standard pain management. secondary hypothesis 1: patients receiving cryotherapy will have lower mme values compared to patients with standard pain management. secondary aim 2: to determine if cryotherapy will result in earlier return to baseline activity as measured by quality of recovery questionnaire (qor). secondary hypothesis 2: patients receiving cryotherapy will return to baseline activity level sooner than those receiving standard pain management. secondary aim 3: to determine if cryotherapy will result in a faster time to discharge as determined by duration between admission to postanesthesia care unit (pacu) and discharge home. secondary hypothesis 3: patient receiving cryotherapy will be have a shorter stay in pacu.

Eligibility criteria:
inclusion criteria: * women undergoing laparoscopic hysterectomy for benign indications within 8 weeks of enrollment * women \>18 years of age * non-emergent surgery * non-pregnant * women undergoing laparoscopic hysterectomy with the minimally invasive surgery team exclusion criteria: * requires surgery for urinary incontinence * has acute angle glaucoma * has severe cardiac/respiratory disease * current chronic pain condition (ie chronic pelvic pain, fibromyalgia, chronic low back pain) * chronic use/abuse of opioid medications for greater than 1 week preceding procedure * chronic nsaid use * current treatment of opioid dependence with methadone or buprenorphine * non-english or non-spanish speaking * procedure converted to laparotomy
a study of mealtime insulin ly900014 in participants with type 2 diabetes using continuous glucose monitoring (pronto-time in range)

Conditions: Type 2 Diabetes

Summary: this study is being done to evaluate glycemic control in participants with type 2 diabetes who are taking mealtime insulin ly900014 in combination with long-acting insulin glargine. participants will use continuous glucose monitoring (cgm) (freestyle libre 14-day system) during the study.


Eligibility criteria:
inclusion criteria: * participants diagnosed (clinically) with type 2 diabetes mellitus (t2d) for at least 1 year prior to screening. * have been treated with basal-bolus multiple daily injection (mdi) therapy for at least 90 days prior to screening including: * basal insulin glargine u-100, in combination with bolus insulin analog (insulin lispro, insulin aspart, or insulin glulisine) with meals. * participant must have been treated with the same type of allowed bolus insulin analog for at least 30 days prior to screening. * participants may be treated with up to 3 of the following oral antihyperglycemic medications (oams) for t2d in accordance with local regulations: 1. metformin 2. dipeptidyl peptidase-4 (dpp-4) inhibitor 3. sodium glucose cotransporter 2 (sglt2) inhibitor 4. oral glucagon-like peptide 1 (glp-1) agonist * doses of oams are required to have been stable for at least 90 days prior to screening. * participants may be treated with injectable glp-1 receptor agonist for t2d in accordance with local regulations. the glp-1 receptor agonist dose is required to have been stable for at least 90 days prior to screening. * have an hba1c value ≥7.5% and ≤10% according to the central laboratory at screening. exclusion criteria: * have been diagnosed at any time with type 1 diabetes mellitus or latent autoimmune diabetes in adults. * have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to screening. * have had any episode of hyperglycemic hyperosmolar state or diabetic ketoacidosis within 6 months prior to screening. * have hypoglycemia unawareness as judged by the investigator.
effects of fasting on success rates of assisted reproductive techologies

Conditions: Sub Fertility, Female; Fertility Disorders; Fertility Issues; Sub-fertility; IVF

Summary: this exploratory study investigates fasting as a potential supportive therapy for infertility treatment in women undergoing in-vitro-fertilization (ivf) / intracystoplamsatic sperm injection (icsi)

this 2-arm, randomized, controlled exploratory clinical trial aims to explore fasting as a novel supportive treatment in female infertility during ivf / icsi. the participants will be randomized in two groups: a fasting group and a waiting list. the intervention group follows a fasting intervention, whereas the patients on the waiting list continue their normal diet. all groups will be trained and accompanied by medical experts. in addition, qualitative interviews will be conducted including individual and focus group interviews with a subgroup of participants.

Eligibility criteria:
inclusion criteria: * women aged 25 to 38 years with planned ivf / icsi * 1 ng/ml ≤ anti-mullerian hormone (amh) ≤ 4 ng/ml * unfulfilled desire to have children \>1 year * 25 kg/m² ≤ bmi ≤ 35 kg/m² declaration of consent exclusion criteria: * language barriers * previously known serious mental illness or cognitive impairment * patients with anatomical/organic damage and proven uterine abnormalities * eating disorders in the medical history * serious previous internal diseases * lack of internet access * no consent to randomisation * participation in other studies

Keywords: fasting natural therapies caloric restriction lifestyle modification dietary restriction dietary intervention complementary medicine integrative medicine intracytoplasmatic sperm injection icsi
ghrelin regulation and structure: effect of thiazolidinedione therapy on ghrelin

Conditions: Obesity; Insulin Resistance

Summary: the purpose of this study is to learn more about how insulin resistance (inability to process glucose correctly resulting in mildly elevated glucose levels) affects the hormone ghrelin.

insulin resistance suppresses fasting ghrelin levels and impairs postprandial ghrelin suppression. improved insulin sensitivity with a thiazolidinedione will raise ghrelin levels, enhance meal-related suppression, but not change the ratio of total to active ghrelin or result in an alteration of ghrelin structure.

Eligibility criteria:
inclusion criteria: * age 18 to 80, weight stable for at least 3 months * at lifetime maximal body weight and impaired glucose tolerance (ict) by the world health organization criteria: * fasting plasma glucose level of 100- 125mg/dl or * plasma glucose level between 140 to 149mg/dl following a 75gram oral glucose load exclusion criteria: * actively losing weight * smokers * alcohol consumption \> 2 drinks/day * prescription drug use * recreational drug use * type 2 diabetes * conditions that contraindicate treatment with pioglitazone such as chf, impaired liver or kidney function or known sensitivity to pioglitazone

Keywords: obesity
prospective randomized trial comparing triple site ventricular stimulation versus conventional pacing in crt candidates

Conditions: Cardiac Resynchronization Therapy

Summary: cardiac resynchronization therapy (crt) is a recommended treatment for selected patients with symptomatic heart failure (hf). although most treated patients show a benefit from crt, a lack of response is observed for about 25-30% of them whatever the response criteria used either based on the clinical status (nyha class, packer clinical composite score) or on ventricular remodeling parameters assessed by echography (left ventricle end of systole volume). this rate has remained remarkably stable since the therapy started and has motivated many studies to better understand the underlying physiopathology and the crt action mechanisms. among the various research axes to improve crt response and responders rate, increasing the number of pacing sites in an attempt to better homogenize the cardiac mechanical activity has been evaluated. a configuration with two rv leads and one lv lead was tested acutely in three studies. in all cases, it demonstrated a significant improvement of cardiac performance whether assessed by echographic parameters or lv dp/dt measurements. additionally feasibility of this approach for long term crt delivery was demonstrated during a previous study. first results with triple-site ventricular stimulation are encouraging and its clinical efficacy should now be tested on a larger population in order to conclude on its interest for crt candidates.


Eligibility criteria:
inclusion criteria: * patient who signed the mec approved informed consent * patient older than 18 * patient with a crt (crt-p or d) indication as per esc guidelines 2013 * left ventricular ejection fraction (lvef) ≤ 35% * nyha class ii/iii/iv despite optimal medical treatment * left bundle branch block (lbbb) and qrs ≥ 120 ms (class ia and ib indications) or in the absence of lbbb qrs \> 150 ms (class iia indication) * de novo implantation * sinus rhythm exclusion criteria: * permanent supra ventricular tachycardia * pacing indication for 3rd degree av block * impossibility to perform fu at the investigative center * pregnancy * adults under legal protection * heart transplant candidates * concomitant pathology that may interfere with the study results

Keywords: symptomatic heart failure
effect of 8 weeks of functional and traditional off-season resistance training on mobility, dynamic balance, technical skills, change of directions, linear sprint, and jump performance in u19 norwegian soccer players

Conditions: Injury;Sports

Summary: to investigate how norwegian youth soccer players' physical and elementary soccer skills are affected after an 8-week training period using the functional football performance system vs. traditional training methods.


Eligibility criteria:
inclusion criteria: * footballers aged 16 to 20 years old playing in the norwegian g19 0. division and norwegian tipping leauge. * experience of at least three years playing football. * minimum seven out of ten on tegner´s activity scale. * the participants must be highly motivated for the project, which will be measured using the - likard scale. eight out of ten is expected (the participant will be anonymous in their registration). exclusion criteria: * illness or injury within the last three months has kept the participant outside of football.

Keywords: groin knee ankle hamstrings