Kornimate/medical-research-clean huggingface dataset:
clinical and metabolic characterization of long-term courses of obesity patients

Conditions: Obesity

Summary: the long-term courses after bariatric surgery are not sufficiently known. furthermore there is a heterogeneity in postoperative responses. the aim of this study is to investigate the glycemic course (prediabetes, development of diabetes) of patients with obesity (bmi\>=35 kg/m2) who had undergone bariatric surgery compared to patients with obesity who have not. a further aim is to investigate predictors of weight development, development of body composition and insulin sensitivity of patients who had undergone bariatric surgery compared to obesity patients who have not undergone bariatric surgery. the long-term courses after different surgical procedures (roux-y vs sleeve) will be compared. in this study 300 patients with obesity who had been metabolically characterized in a previous study will be recruited. these patients are examined (medical history, physical examination including ecg, bia, weight, height) and metabolically characterized. participants without diabetes undergo a glucose tolerance test and fasting blood sampling will be performed in participants with diabetes. all patients complete questionnaires to activity, nutrition, life quality, impulsiveness, depression and eating behavior. randomly selected participants will be offered an abdominal fat tissue biopsy. when consent is given, this will be performed at least two days after the glucose tolerance test.


Eligibility criteria:
inclusion criteria: * participation in the study " das adip-programm: charakterisierung adipöser probanden mittels genauer phänotypischer und genotypischer klassifizierung" exclusion criteria: * bmi \< 35 kg/m2 at start of the previous study * women during pregnancy and lactation * patients who are unable to give their consent * patients who have undergone surgery within the last 3 months * acute disease or infection within the last 4 months * hiv- or hepatitis b/c-positive * for biopsy of fat tissue: known coagulation disorder or ptt or inr out of reference range
primary prevention youth suicide trial in colorado high schools prevention among colorado high school students

Conditions: Suicide; Sexual Violence

Summary: sources of strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the national registry of evidence based programs and practices (nrepp). this project will expand the existing evidence base by evaluating sources of strength for sexual violence outcomes in a randomized controlled trial (rct) in twenty-four high schools.

at present few programs systematically address broader social-ecological factors such as school-wide norms and youth-adult connectedness that research identifies as major drivers of sexual violence. to address this gap, this application proposes a large-scale rct evaluation of sources of strength to evaluate for sexual violence perpetration outcomes. sources of strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the national registry of evidence based programs and practices (nrepp). this project will expand the existing evidence base by evaluating sources of strength for sexual violence outcomes, which has never been done before. twenty-four high schools will be recruited and stratified (rural or urban) and randomly assigned to one of two conditions: (a) immediate sources of strength intervention, (b) wait-list for sources of strength implementation after 16 months.

Eligibility criteria:
inclusion criteria: * high school student in participating school, parents did not withdraw from study exclusion criteria: * none
gingival crevicular fluid vaspin and omentin levels in obese patients with chronic periodontitis

Conditions: Obesity; Periodontitis

Summary: our objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the gcf levels of vaspin and omentin in patients with chronic periodontitis in order to determine the usefulness of vaspin and omentin as a diagnostic and prognostic biomarker of periodontal disease.

all individuals underwent a full-mouth periodontal examination, which included probing pocket depth (ppd), clinical attachment level (cal), plaque index (pi), gingival index (gi), bleeding on probing (bop). bmi and whr were used for assessing obesity. in addition, hba1c and fasting plasma glucose levels were used for elimination of diabetes mellitus. based on the periodontal and anthropometric measurements, individuals (n=76) were divided into four groups: the periodontal-healthy group (n=19), chronic periodontitis group (n=19), periodontal-healthy with obesity group (n=19) and chronic periodontitis with obesity group (n=19). periodontitis patients received nonsurgical periodontal therapy. gcf sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. vaspin, omentin, and tnf-α levels were measured by enzyme-linked immunosorbent assay.

Eligibility criteria:
inclusion criteria: 1-) 30-49 years of age 2-) had a minimum of 20 natural teeth, excluding third molars 3) glycosylated hemoglobi levels \<6% 4) fasting plasma glucose levels \<100 mg/dl. 5-) criteria for the periodontal healthy group were gi = 0, ppd≤ 3 mm, and no signs of attachment and bone loss by clinical and radiographic examination. 6-) criteria for the chronic periodontitis group were clinical signs of inflammation (red color and swelling of the gingival margin), gi ≥ 2, ppd and cal ≥ 5 mm, and bone loss affecting \>30% of the existing teeth on clinical and radiographic examination. 7-) criteria for obese groups were 30≤ bmi \<40 kg/m2, and concomitant whr ≥0.85 for females and whr ≥0.90 for males. 8-) criteria for normal-weight groups were 20≤ bmi \<25 kg/m2, and whr below that determined for obesity. exclusion criteria: 1. aggressive periodontitis, 2. periapical pathologies 3. excessive forces including mechanical forces from orthodontics and occlusion 4. systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions) 5. chronic high-dose steroid therapy, radiation or immunosuppressive therapy 6. pregnancy, lactation, 7. smoking within the past five years, or allergy or sensitivity to any drug. 8. had no history of periodontal therapy or drug therapy (e.g., anti-inflammatories, antibiotics, or any other pharmacological treatment) for at least six months.

Keywords: visceral adipose-specific serpin intelectin 1 (omentin) tumor necrosis factor-alpha
two-stage hybrid ablation or thoracoscopic epicardial ablation for long-standing persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: hybrid ablation, as an emerging strategy for atrial fibrillation (af) in recent years, shows encouraging outcomes in many medical centers. a lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent af, especially long-standing persistent af (lspaf). but it is still lack of high level evidence to prove it. this study focus on patients with long-standing persistent atrial fibrillation (lspaf). in order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of lspaf patients.

in this study, all selected lspaf patients will receive thoracoscopic surgical ablation. after 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into hybrid group and surgical group randomly and equally. patients of hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. in followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients. during the 2-year follow-up, 7d-holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (tte). physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.

Eligibility criteria:
inclusion criteria: * older than 18 years old. * nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively. * written informed consent exclusion criteria: * secondary atrial fibrillation caused by other reversible diseases. * left atrial diameter \>55mm confrimed by transthoracic echocardiography. * intracardial mass or thrombus. * previous cardiac surgery. * uncontrolled heart failure or lvef less than 30%. * severe chest wall deformity. * possibly pleural adhesion or pericardial adhesion caused by previous thoracic surgery, tuberculosis or constrictive pericarditis. * severe comorbidities (e.g. severe cad, severe renal failure, severe liver failure). * life expectancy less than 2 years (e.g. patients with mods or cancer) * unsuitable for radiation exposure (e.g. pregnancy)

Keywords: atrial fibrillation hybrid ablation surgical ablation
tarka® vs. lotrel® in hypertensive, diabetic subjects with renal disease (tandem)

Conditions: Hypertension; Diabetes; Proteinuria

Summary: the primary objective of this study is to determine if trandolapril/verapamil (tarka®) is superior to amlodipine/benazepril (lotrel®) in reduction of albuminuria in hypertensive subjects with type 2 diabetes mellitus (dm) and diabetic nephropathy


Eligibility criteria:
inclusion criteria: * diabetes * hypertension * albuminuria exclusion criteria: * type 1 dm. * subject has severe hepatic dysfunction at screening as determined by liver function tests: * bilirubin \> 2.0 mg/dl. * alt and/or ast \> 3 times the upper limit of normal. * subject has poorly controlled diabetes, based on hba1c \> 10% at screening. * subject has non-diabetic renal disease. * subject has a hypersensitivity to ace inhibitor, ccb, torsemide or sulfonylureas.

Keywords: hypertension diabetes proteinuria tarka lotrel
hemostatic procedure after biopsy of the cervix

Conditions: Uterine Cervical Dysplasia

Summary: cytological abnormalities of the cervix uteri need to be clarified by colposcopy biopsy. to avoid bleeding after biopsy, monsel´s paste is a common used agent. in a randomized clinical trial the use of monsel´s paste after biopsy will be compared to no intervention. the primary outcome of the study is blood loss, secondary outcomes are pain, satisfaction of the patient and influence of independent factors such as age and body mass index.


Eligibility criteria:
inclusion criteria: * abnormal pap smear * first colposcopy ever exclusion criteria: * pregnancy * bleeding disorder * the use of blood thinner * language barrier * unwillingness to participate

Keywords: cervical dysplasia colposcopy haemostatic procedure biopsy of the cervix uteri
effects of a community-based group rehabilitation program for dynamic balance and mobility post stroke

Conditions: Sequelae of Stroke

Summary: stroke patients clearly benefit from intensive and coordinated inpatient care. while inpatient rehabilitation care is the preferred form for many patients post-stroke, due to access and financial barriers, many patients do not have this option. community, outpatient rehabilitation programs will allow the patients with moderately disabling strokes the opportunity to maintain or augment gains achieved during inpatient stroke rehabilitation , while allowing some patients with mild disability to avoid inpatient rehabilitation completely. objective: phase 1 randomized control trial to test the efficiency and effectiveness of treating adults who have suffered a single stroke using the following essential treatment components; a) community setting, b) group activity program, c) flexible, task-specific, computer-based exercise regime this program is designed to allow an extension of the in-patient rehabilitation experience to a community-based setting, in a cost-effective manner using paraprofessional staff and rehabilitation specialists, to provide a challenging, functional program to promote recovery and independence from physical impairments affecting balance and walking. the specific objectives are to: 1. assess the benefits and feasibility of the multi-functional group exercise intervention for balance and mobility in a community setting. secondary objectives 2. identify effective combinations of exercises \& activities that translate to increased abilities and participation levels. hypothesis: intense training targeting standing balance, and walking will significantly improve stroke clients' functional mobility. training in a group setting and incorporating interactive and engaging computer gaming further provides the benefits of motivation and peer support while providing treatment in a cost effective manner.


Eligibility criteria:
inclusion criteria: 1. community dwelling individuals, who have suffered a single stroke of thrombic -embolic or hemorrhagic origin in the last 3-12 months and are waiting for outpatient rehabilitation , 2. aged 50-70 years, 3. montreal cognitive assessment score greater than 26, 4. english-speaking and possess the ability to understand the nature of the study and provide informed consent, 5. independent in sit to stand transfer and ambulatory functions, with or without an assistive device (cane or walker), f ) gait speed (average over 25 meters) between 0.3 and 0.8 m/s and berg balance scale score of less than 45. exclusion criteria: any medical condition or disability that prevents participation in an exercise program. for example, a reported medical history of current treatment for cancer, kidney disease, recent fracture, uncontrolled diabetes or seizure disorder, uncontrolled cardiovascular-related problems . -

Keywords: community-stroke-rehabilitation, group-exercise, balance-mobility-exercise, instrumented treadmill
resistance training in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to determine whether: 1. progressive resistance training improves pain and disability 2. progressive resistance training improves muscular strength, ability to walk and quality of life

patients in experimental group participated in a 12-week progressive resistance training using a repetition maximum (rm) exercise in which patients performed 1rm with the maximum bearable weight. once the 1rm was determined, training was divided into the following regimen: 2 series of 8 repetitions, the first with 50% and the second with 70% of 1rm. the exercises were knee extension and flexion and hip abduction and adduction, all performed in machines. the 1rm load was reevaluated every 2 weeks. the control group remained on a three-month waiting list for physiotherapy. patients were assessed for pain, function, quality of life, muscle strength and six-minute walk test.

Eligibility criteria:
inclusion criteria: * woman * age between 40-70 years old * pain between 3 and 8 on a 10-point numeric pain scale * radiographically confirmed knee oa exclusion criteria: * inflammatory diseases or any comorbidity that prohibit exercises, regular physical activity * trip plans for the next 12 months

Keywords: knee osteoarthritis exercise
randomized controlled trial in liver transplant recipients treated in steroid sparing regimen

Conditions: Chronic Hepatitis C; Organ Transplantation; Immunosuppression

Summary: liver transplant subjects will be given mycophenolate (mmf) and tacrolimus in order to help prevent post-transplant rejection.

recurrent hcv in the liver allograft is becoming the leading indicator for retransplantation. studies suggest that glucocorticord-based immunosuppression regimens hasten the onset and progression of recurrent chronic hcv liver disease. treatment of acute allograft rejection with steroid boluses is also associated with rapid hcv recurrence. the relative contribution of various calcineurin inhibitors to recurrent hcv liver disease has not been established. previous retrospective studies, as well as prospective studies have not demonstrated a difference in recurrent hcv liver disease rates between patients receiving csa or tacrolimus immunosuppression regimens respectively.

Eligibility criteria:
inclusion criteria: * adult patients who have received liver transplant exclusion criteria: * pregnant women * nursing women
timing of surgery and outcome in burn patients ( earlyburn )

Conditions: Burns

Summary: the prognostic of burn patients has improved over the last decades. early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. best timing for burn excision remain uncertain, however. in this multicenter observational study, we aim at exploring the impact of timing of surgery on outcome in severely ill burn patients using a propensity analysis.

the first aim of the study is to explore the impact of timing of the first surgery on outcome of severely ill burn patients. because a randomization would not be feasible in this setting, we will use a propensity analysis in matching patients receiving early surgery and those receiving late surgery. secondary aims are to evaluate the impact of the timing of surgery on morbidity (organs failure, infections, sepsis) but also to assess the diagnostic and prognostic value of plasma and urine biomarkers in severely ill burn patients

Eligibility criteria:
inclusion criteria: * age \>18 years * admission to a burn unit within 72 hours from a burn injury * total burned surface area (tbsa)\>20%(2nd degree or 3rd degree) for any type of burn * patient covered by the social security * non-opposition to participate to the study and to the constitution of the biological collection exclusion criteria: * decline to participate * decision not to resuscitate order before surgery * pregnant or breastfeeding patiente * decision to limit therapies in the first 24 hours * patient not resident in france * patient deprived of liberty

Keywords: burns critically ill surgery outcome mortality
reference range study for the quantra qstat system

Conditions: Coagulation Disorder

Summary: the objective is to determine the reference range intervals for the parameters reported by the quantra system with the qstat cartridge.

this is a multicenter, prospective, observational study of a healthy adult population with normal coagulation function to determine the reference range intervals for the parameters reported by the quantra system with the qstat cartridge. the threshold for the clot stability to lysis (csl) parameter will be determined from the csl reference range.

Eligibility criteria:
inclusion criteria: * subject is 18 years or older * subject is willing to participate and has signed a consent form * subject's laboratory coagulation test results at screening are within each test's normal reference range. exclusion criteria: * subject is younger than 18 years * subject has a history of a coagulation disorder * subject is pregnant or lactating * subject is currently taking medications known to alter coagulation * subject has one or more laboratory coagulation test results outside of the normal reference range at screening * subject had a blood transfusion or surgery within the last month * drug abuse * excessive alcohol consumption * subject is unable to provide written informed consent * subject is incarcerated at the time of the study * subject previously participated in this study
phase 3 study of pelubiprofen & loxoprofen in patients with upper respiratory tract infection

Conditions: Acute Upper Respiratory Infection; Fever

Summary: multi-center, randomized, double blind, controlled parallel-group comparative phase 3 clinical trial to assess the efficacy and safety of pelubiprofen compared to loxoprofen in patients with acute upper respiratory infection.


Eligibility criteria:
inclusion criteria: 1. over 15 years old 2. male and female 3. patients with fever over 38.0°c due to cold (acute upper respiratory tract infection) 4. patients with upper respiratory tract infection outbreak within 2 days and who did not received drug administration 5. subjects who voluntarily or legal guardian agreed with written consent exclusion criteria: 1. fever reducer administration within 4 hours from the screening point 2. any incidence of febrile crisis from the past six months 3. patients with ulcers, gastrointestinal disorders which are confirmed by endoscopy 4. patients with continuously administrating gastrointestinal disorder related drug 5. patients with severe blood damage 6. severe hepatic impairment (alt, ast value more than 2 times the upper limit of the normal range) 7. with severe renal impairment (serum creatinine value is more than 2 times the upper limit of the normal range) 8. patients with severe left ventricular dysfunction

Keywords: pelubi pelubiprofen loxoprofen anti-pyretic fever
postoperative pain management of caesarean section

Conditions: Postoperative Pain; Caesarean Section; Analgesia

Summary: caesarean section is one of the most frequent surgeries causing severe postoperative pain. poor management of acute pain can contribute to postoperative complications, late recovery and the development of chronic pain. moreover, it had been demonstrated that the intensity of postpartum pain is associated with depression. it is imperative to find out appropriate methods of postpartum pain alleviation. currently, a lot of analgesic drugs and methods have been developed and used in clinical practice, such as patient-controlled analgesia, extended-release analgesics and multimodal analgesia. this prospective cohort study is aimed to investigate the outcome of each postoperative analgesic method used in caesarean section.

this is a prospective, observational, cohort study. patients undergoing elective caesarean section will be invited to the study. the written informed consent will be obtained prior to participation. after getting the written informed consent, data will be collected from medical records, questionnaires, patient diaries, visit records and telephone visit records. through telephone visits, postpartum depression scale and postpartum chronic pain will be evaluated six weeks and three months after delivery. demographic data, consumption of analgesics, analgesic methods, intensity of postoperative pain, complications, recovery time, score of depression scale will all be summarized. numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.

Eligibility criteria:
inclusion criteria: 1. aged 20 to 40. 2. planing to undergo caesarean section with spinal anesthesia. 3. scheduled to undergo cesarean section between 37 and 40 weeks of gestation. 4. american society of anesthesiology physical class 1-2. 5. planing to alleviate postoperative pain with intravenous patient-controlled analgesia or administration of naldebain. exclusion criteria: 1. not willing to provide informed consent. 2. unable to receive opioids or nsaids due to contraindication. 3. long-term use of opioids or drug abuse. 4. suffering from chronic pain disease. 5. having medical history of mental illnesses. 6. diagnosed with pre-eclampsia or eclampsia. 7. diagnosed with gestational diabetes. 8. unsuitable for participation judged by investigator.

Keywords: postoperative pain caesarean section postpartum rehabilitation dinalbuphine sebacate pca naldebain