Kornimate/medical-research-clean huggingface dataset:
effect of gastric bypass surgery on energy metabolism

Conditions: Obesity

Summary: the purpose of this study is to investigate the short term and long term effects of roux-en-y gastric bypass (rygb) surgery on energy expenditure, gastrointestinal and appetite regulating hormone levels, and appetite sensation. we hypothesize that following rygb surgery, metabolism will be elevated in comparison to patients who have not yet had rygb but who are losing weight simultaneously using a low calorie diet. we further hypothesize that this higher metabolism will be associated with alterations in fasting and postmeal levels of gastrointestinal and appetite regulating hormones. long term (1.5 years after rygb), we hypothesize that differences in metabolism, body composition, and hormone levels will distinguish between patients who have maintained their weight loss after rygb vs those who have regained weight.


Eligibility criteria:
inclusion criteria: * age 18-65 * bmi ≥40, or ≥35 with concomitant obstructive sleep apnea, or hypertension * scheduled for rygb surgery at hvidovre hospital, copenhagen, denmark * must have lost between 1-4% body weight after 3 months of dietary counselling exclusion criteria: * deemed ineligible for rygb surgery by patient's own physician(s) * diabetes mellitus * non caucasian * weight \>160kg (due to dexa scanner limitations), or morphologically unable to accommodate in dexa scanner (\>40cm in maximum supine anterior-posterior dimension, or \>60cm in maximum supine body width) * hemoglobin \<7.0 mmol/l * psychiatric illness under the care of a psychiatrist * eating disorder such as bulimia * patients on special diets (eg vegetarian, atkins) * any history of thyroid dysfunction, or use of thyroid medication (with the exception of transient thyroiditis) * hypothalamic or genetic etiology of obesity * a current diagnosis of cancer * any surgery other than rygb planned in the ensuing 3 months * substance abuse or smoking * use of prescription medications or over-the-counter drugs affecting metabolism * excessive intake of alcohol (\>7 drinks/week) * excessive intake of caffeine (\>300 mg/day) * presence of any contraindication to use of a low calorie powder diet, including: * past history of ventricular arrhythmias (even if treated) * renal dysfunction (creatinine clearance \<60 ml/min) * liver enzymes (alt or ast) \>3x upper limit of normal * milk protein allergy, or lactose intolerance * porphyria or phenylketonuria * history of gout * breastfeeding * concomitant use of monoamine oxidase inhibitors or non potassium sparing diuretics * inability or unwillingness to comply with a low calorie diet protocol * patients who find the powder diet products to be unpalatable * do not enjoy yogurt, carrots, or milk (as these are essential elements of the low calorie diet)

Keywords: obesity bariatric surgery energy expenditure incretins appetite regulation body composition glp-1
kuleuven intensive insulin therapy study in medical intensive care patients

Conditions: Critical Illness

Summary: in a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. whether this intervention also improves prognosis of medical intensive care patients remains unknown. the current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. on admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

in a previous study, we showed that tight blood glucose control with insulin during intensive care reduced morbidity and mortality of surgical intensive care patients. whether this intervention also improves prognosis of medical intensive care patients remains unknown. the current prospective, randomized, controlled study will assess the impact of intensive insulin therapy on the outcome of patients in a medical intensive care unit. on admission, patients will be randomly assigned to either strict normalization of blood glucose (80-110 mg/dl) with intensive insulin therapy or the conventional approach, in which insulin infusion is initiated only when blood glucose exceeds 215 mg/dl, to maintain blood glucose levels between 180 and 200 mg/dl.

Eligibility criteria:
inclusion criteria: * adults admitted to icu and anticipated to require intensive care for at least a few days exclusion criteria: * expected short icu stay * therapy restricted upon admission * surgical icu patients * other studies * below 18 years * pregnancy

Keywords: critical illness intensive care outcome insulin blood glucose
contour 3d®/triad® tricuspid annuloplasty ring post-market clinical trial

Conditions: Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency

Summary: the purpose of this study is to gather clinical information on the hemodynamic performance of the contour 3d® and tri-ad® tricuspid annuloplasty rings in a post-market environment.

the primary goal of the tv repair procedure is to relieve patients from tv insufficiency or reduce tv stenosis. this study will evaluate the hemodynamic efficacy of the contour 3d® and tri-ad® ring and characterize the effect of the tv repair through assessment of right atrial size and right ventricular function. additionally, this study will characterize the patient population for whom a contour 3d® or tri-ad® ring is chosen to repair tv insufficiency. health status and adverse events (ae) will be assessed.

Eligibility criteria:
inclusion criteria: * subject or legal guardian willing and able to sign and date the informed consent form (and authorization to use and disclose health information form, if applicable) * subject indicated for a concomitant surgical repair of the tv * subject is willing to return for required follow-up visits to the hospital where the implantation originally occurred exclusion criteria: * subject with a degenerative tv condition * subject with primary tv regurgitation * subject with a previous tv repair or replacement * subject indicated for a stand-alone tv repair * subject currently participating in an investigational drug or another device study * subject with life expectancy of less than one year * subject is pregnant or desires to be pregnant within 12 months following implantation * subject is under 18 or over 85 years of age * subject with active endocarditis * subject with valvular retraction with severely reduced mobility * subject with a heavily calcified tv
study of the qol evaluation of trelagliptin in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only.

the purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only. eligible participants will be randomized to either the study drug (trelagliptin) group or the comparative drug (daily dpp-4 inhibitor) group. treatment burden will be assessed using diabetes therapy related -qol (dtr-qol) questionnaire and diabetes treatment satisfaction questionnaire (dtsq).

Eligibility criteria:
inclusion criteria: 1. participants diagnosed as type 2 diabetes. 2. participants with a stable diet and exercise therapy only for at least 12 weeks prior to the start of the screening period. 3. participants who require a dpp-4 inhibitor treatment. 4. participants with hemoglobin a1c (hba1c) \>=6.5 % and \<10.0 % at the start of the screening period. 5. participants who completed dtr-qol questionnaire at the start of the screening period. 6. participants who have received less than 2 types of medication for treatment of comorbidities (such as hypertension or dyslipidemia) at the start of the screening period (any number of daily doses). 7. participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements. 8. participants who can provide the written informed consent prior to the initiation of any study procedures. 9. participants aged \>=20 years at the time of informed consent. 10. outpatient. exclusion criteria: 1. participants who are receiving any oral anti-diabetic medication for the treatment of type 2 diabetes at the start of the screening period. 2. participants diagnosed with type 1 diabetes. 3. participants with severe renal impairment or renal failure (e.g., estimated glomerular filtration rate (egfr) \<30 ml/min/1.73 m\^2 or on dialysis). 4. participants with serious heart disease or cerebrovascular disorder, or serious pancreatic, blood, or other disease. 5. participants with a history of gastrointestinal resection. 6. participant with a proliferative diabetic retinopathy. 7. participant with malignancy. 8. participants with a history of hypersensitivity or allergy to dpp-4 inhibitors. 9. pregnant, lactating or planning pregnancy during the study period. 10. participants who may need to add or discontinue concomitant medication or change the dose during the study period. 11. participants who will require treatment with a prohibited concomitant medication during the study period. 12. participants participating in other clinical studies. 13. participants assessed ineligible in the study by the principal investigator or the investigator.
kiwifruit effect on periodontal inflammation kiwifruit effect on periodontal inflammation

Conditions: Periodontitis

Summary: the importance of micronutrients has been extensively reviewed and it was concluded that for prevention and treatment of periodontitis daily nutrition should include sufficient antioxidants, vitamin d and calcium. up to now there is limited research available investigating the effect of vitamin c supplementation on the periodontal condition. supplementation of vitamins and micronutrients has however raised numerous questions on clinical efficacy. recently, a significant increase of medical literature on the effect of nutraceutical dietary aliments on general health has been noted. the aim of the present study is twofold. the first objective is to investigate the effect of twice-daily kiwifruit consumption as sole treatment modality in untreated periodontitis, followed after two months by initial periodontal therapy supported by continued kiwifruit consumption. the second objective is to investigate the effect of twice daily kiwifruit consumption on periodontal and systemic parameters of these periodontitis patients 3 months after treatment.


Eligibility criteria:
inclusion criteria: * proximal attachment loss of ≥3 mm in ≥2 non-adjacent teeth, * ppd≥4 mm and bleeding on probing on at least 25 % of their total sites * documented radiographic bone loss exclusion criteria: * younger than 18 years or older than 70 years, * pregnant or lactating females, * females using contraceptive pharmacological medications, * reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases, * in need of antibiotic treatment during initial periodontal treatment (ipt), * ipt in the previous 6 months, * allergic to latex, kiwifruit and fruits in general, * suffering of eating or digestive disease or food intolerances, * smoking more than 20 cigarettes per day.
cognitive-behavioral therapy for disruptive behavior in children and adolescents

Conditions: Disruptive Behavior; Aggression; Anger; Irritability; Noncompliance

Summary: this is a randomized controlled study of cognitive-behavioral therapy (cbt) for disruptive behavior such as irritability, anger and aggression in children and adolescents. cbt will be compared to supportive psychotherapy (spt) and participants of this study will be randomly assigned (like the flip of a coin) to receive cbt or spt. participants will be also asked to complete functional magnetic resonance imaging (fmri) and electrophysiological (eeg) tasks (recordings/images of brain activity) before and after treatment.

cognitive-behavioral therapy (cbt) is a behavioral intervention that consists of 12 weekly sessions. during cbt children are taught various skills for coping with frustration and parents are taught various strategies for managing situations that can be anger provoking for their child. this study is conducted to examine whether reduction of behavioral problems including anger outbursts, irritability, aggression and noncompliance after cbt may be paralleled by changes in areas of the brain responsible for emotion regulation and social perception.

Eligibility criteria:
inclusion criteria: 1. boys and girls, 8 to 16 years of age. 2. t-score \> 65 on the parent-rated aggressive behavior scale of the child behavior checklist (cbcl). 3. unmedicated or on stable medication for aggression, adhd, anxiety, or depression for at least 6 weeks, with no planned changes for duration of study. 4. children can speak english sufficiently enough to participate in cbt and study assessments. 5. children should have 1) no metal medical implants, 2) a body weight of less than 250 lbs. and 3) no claustrophobia. \[these are necessitated by the safety requirements of the fmri.\] 6. children should be able to meet fmri data quality requirements at baseline \[to enable pre- to post-treatment comparison.\] 7. families can commute to the yale child study center in new haven, ct for weekly visits. exclusion criteria: 1. iq below 85. 2. children across various dsm diagnoses will be eligible for participation. however, significant levels of psychopathology that require immediate clinical attention such as severe depression or psychosis will be exclusionary because it will require alternative treatments. 3. significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder, brain injury based on medical history which can interfere with participation in the study. 4. concurrent psychotherapy can continue, but cbt for aggression is exclusionary. subjects will be asked not to initiate any new child psychotherapy during the study.

Keywords: child cognitive behavioral therapy cbt aggression disruptive behavior treatment frustrative non-reward irritability
evaluation of the effect of a probiotic supplement upon gastrointestinal function

Conditions: Signs and Symptoms, Digestive; Dyspepsia

Summary: the purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (gi) function.

sixty volunteers with functional gi disorders (functional dyspepsia according to rome-iii criteria) will be recruited for a randomised, double-blind, placebo-controlled, two-arm parallel study in which the effect upon the gastrointestinal function of a probiotic mix containing bifidobacteria and lactobacilli (manufactured by biopolis sl) will be compared with placebo (maltodextrin). the study design includes a 4 week run-in period, in which the volunteers will not consume any probiotics/prebiotics, followed by a 4 weeks intervention period (a daily capsule of placebo or probiotic) and an 8 weeks washout period. at the beginning/end of each period questionnaires in gastrointestinal function, dyspepsia related symptoms and diet will be carried out. a serum sample will be taken for cytokine levels determination. a faecal sample will be taken for 16s microbial population profiling and for determining the faecal levels of bifidobacterium, bacteriodes, faecalibacterium, akkermansia, lactobacillus and blautia by qpcr and the concentration of the main bacterial metabolites; acetate, propionate and butyrate by gas-chromatography.

Eligibility criteria:
inclusion criteria: * functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to rome iii criteria exclusion criteria: * celiac disease or other organic gi disease * orthorexia nervosa or other eating disorders * special dietary patterns (vegans, vegetarians, macrobiotic, exclusion diets, etc.) * extreme bmi (\ 39,9) * metabolic disorders * positive helicobacter pylori test * congenital iga deficiency * lactose malabsorption/intolerance * sibo * diabetes * scleroderma, crest, lupus or other connective tissue diseases * previous gi surgery or neoplastic disease * treatment with non steroidal anti-inflammatory drugs and/or acetyl salicylic acid. * pregnancy * menopause

Keywords: functional dyspepsia abdominal pain flatulence probiotics bifidobacterium lactobacillus
c2p - phase iii: mpowerment and community promise

Conditions: HIV Infections

Summary: one of the objectives of the c2p coalition is the successful delivery of a cdc-endorsed community-level hiv prevention program aimed at changing the risk profiles of youth. this protocol (atn 041) describes the program, community promise (peers reaching out and modeling intervention strategies) or mpowerment, and plans for adapting and implementing it. there are a total of 4 interventions that a community can implement.

community promise: role model stories comprise the "heart" of printed materials distributed throughout the target community. the role model stories are brief publications that depict personal accounts from individuals in the population of focus who have made or are planning to make a risk-reducing behavioral change. the messages in the role model stories are reinforced by interpersonal communication with trained peer advocates. mpowerment: is a community level hiv/std prevention program that relies on peer advocates from the community to lead outreach activities including discussion groups (m-groups), venue-based outreach, social events and a publicity campaign. sites will adapt mpowerment for local use remaining faithful to the core elements.

Eligibility criteria:
community promise: inclusion criteria 1. adolescents and young adults who provide verbal confirmation that their age is within 2. the range of 12 through 24 years, inclusive. 3. gender will reflect that of the population of focus. 4. must report having engaged in voluntary sexual activity within the past 12 months (vaginal, anal and/or oral sex). 5. ability to understand and willingness to provide informed consent/assent. exclusion criteria 1. visibly distraught and/or visibly emotionally unstable (e.g., depressive mood, or exhibiting manic, suicidal, or violent behavior). 2. visibly intoxicated or under the influence of psychoactive agents 3. clinically presents as acutely ill. mpowerment: inclusion criteria 1. male adolescents and young adults who provide verbal confirmation that their age is within the range of 12 through 24 years, inclusive. 2. must report having engaged in voluntary sexual activity within the past 12 months (anal and/or oral sex) with a man. 3. ability to understand and willingness to provide informed consent/assent. exclusion criteria 1. visibly distraught and/or visibly emotionally unstable (i.e., depressive mood, 2. or exhibiting manic, suicidal, or violent behavior, etc.). 3. visibly intoxicated or under the influence of psychoactive agents. 4. clinically presents as acutely ill.

Keywords: ymsm hiv/aids condom use drug users minority women
tissue glue vs metallic tackers in mesh fixation during tapp repair.

Conditions: Hernia

Summary: this is a randomized control trial intending to study the clinical difference between different mesh fixation techniques in laparoscopic tapp hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

laparoscopic transabdominal preperitoneal ( tapp ) hernioplasty has emerged as an essential procedure for adults complaining of both unilateral and bilateral inguinal hernia , various descriptions of the procedure have been published recently, complications and recurrence rates are being calculated for each method, different mesh fixation techniques are being used by different surgeons, some use surgical tackers, some use fibrin glue and some demonstrated an equal outcome if the mesh was not fixed at all. this is a randomized control trial intending to study the clinical difference between those different mesh fixation techniques in laparoscopic tapp hernioplasty of inguinal hernia for adults with unilateral and bilateral inguinal hernia , two techniques are tissue glue and surgical tackers , the target population will be divided according to an electronic generated randomization into two groups , they will be compared according to multiple variables which includes but not limited to : procedure time, early post op complication , post-operative pain , late complications , short term and long term recurrence rates .

Eligibility criteria:
inclusion criteria: * all adult patients ages between 18 and 80 years old, males and females, inguinal hernias, unilateral or bilateral and femoral hernias. exclusion criteria: * operations which were converted from tapp to other procedures (such as open repair or tep). * patients who were unfit for general anesthesia * patients who refused to participate in the study * patients with chronic pain disorders requiring long term pain management before the procedure. * cases with complicated hernias that required emergency repair.

Keywords: laparoscopic tapp tissue glue tackers hernia
study on mafld-related cirrhosis prevention and treatment strategies

Conditions: Metabolic Dysfunction-associated Fatty Liver Disease; Cirrhosis

Summary: to establish a prospective, multicenter, biopsie-confirmed clinical cohort of mafld-related cirrhosis (f3-f4) in china, and analyze the clinical, histopathological features and natural outcomes of mafld-associated liver fibrosis/cirrhosis in china. and than to conducted a real-world study of different strategies of chinese characteristics for the prevention and treatment of mafld-related cirrhosis to evaluate the efficacy and safety of the strategies.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years old, gender and ethnicity are not limited; 2. meet the diagnostic criteria for mafld; 3. f0-f4 stage of liver fibrosis confirmed by liver biopsy within 24 weeks; 4. be willing to sign informed consent. exclusion criteria: 1. cirrhosis due to any chronic liver disease other than mafld (including but not limited to alcohol or drug abuse, medications, chronic hepatitis b or c, autoimmune, hemochromatosis, wilson's disease, alpha1-antitrypsin deficiency); 2. any clinical evidence or history of peritonitis, varicose bleeding, or spontaneous encephalopathy; 3. according to the investigators' assessment, a history of heavy drinking for more than 3 months continuously within the previous year was selected. (note: heavy drinking was defined as more than 20 g per day on average for female subjects and more than 30 g per day for male subjects). 4. use of nafld-related medication history (amiodarone, methotrexate, systemic glucocorticoids, tetracycline, tamoxifen, larger than hormone replacement doses of estrogen, anabolic steroids, valproic acid, and other known hepatotoxins) for more than 2 weeks within the year prior to screening.

Keywords: treatment strategies multicenter real-world study