Kornimate/medical-research-clean huggingface dataset:
dss: diabetes surgery study - intensive medical management of type 2 diabetes, with and without gastric bypass surgery

Conditions: Type 2 Diabetes; Cardiovascular Disease

Summary: the present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with bmi from 30.0 to 39.9 kg/m2. this program will determine the relative effectiveness of rygb combined with intensive medical management (imm), versus imm alone, in reducing cvd event rates and mortality in patients with poorly controlled diabetes. imm will include rigorous lifestyle modification for weight loss and stepped pharmacologic treatment for diabetes and other cvd risk factors. the proposed study is a randomized trial which will provide an assessment of the efficacy of treatment, in reducing cvd risk factors and also assessing the feasibility, cost, and safety of a larger trial.


Eligibility criteria:
inclusion criteria: 1. age 30 to 67 years at eligibility visit. 2. diagnosed with t2dm at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, and hba1c ≥ 8.0 %. 3. body mass index (bmi) ≥ 30.0 kg/m2 and ≤ 39.9 kg/m2 at eligibility visit. 4. willingness to accept random assignment to either treatment group. 5. expect to live or work within approximately one hour's traveling time from the study clinic for the duration of the two-year trial. 6. willingness to comply with the follow-up protocol and successful completion of the run-in (described below). 7. written informed consent. exclusion criteria: 1. cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months. 2. current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. 3. cardiac stress test indicating that surgery or imm would not be safe. 4. pulmonary embolus or thrombophlebitis in the past six months. 5. cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years. 6. significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. 7. serum creatinine ≥ 1.5 mg/dl. 8. hba1c \> 14.0%.

Keywords: t2 diabetes type 2 diabetes cvd event rates and mortality
the effect of epidural analgesia on intracranial pressure by measuring the optic nerve sheath diameter using ultrasound in pediatric patients with cerebral palsy

Conditions: Cerebral Palsy

Summary: ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. the aim of this study is to evaluate the effect of epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing osteotomy of lower extremity. forty patients, aged 4 years to 13 years, receiving epidural block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20). randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. in contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. the primary endpoint is the difference in the optic nerve sheath diameter after epidural block measured by optic nerve ultrasonography between groups.


Eligibility criteria:
inclusion criteria: * pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy * body weight ≤ 40 kg exclusion criteria: * patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.) * patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure * patients with ophthalmic disease or surgery * the estimated operation time is less than 70 minutes. * all parents of the subject are foreigners or illiterate
a post-market retrospective study on revision total knee arthroplasty using medacta gmk® revision prosthesis

Conditions: Osteoarthritis

Summary: this is a retrospective, single-site observational study, designed to assess the clinical outcomes and collect safety data of gmk revision knee system used for primary or revision total knee arthroplasty at minimum two years post-treatment.


Eligibility criteria:
inclusion criteria: * patients who are willing and able to provide written informed consent for participation in the study. written informed consent must be obtained prior to any study procedure. * patients with ability to understand and provide written authorization for use and disclosure of personal health information * patients must be willing to comply with the post-operative evaluation schedule. * patients underwent either a primary or revision total knee replacement for any type of etiology (osteoarthritis, avascular necrosis, rheumatoid arthritis, post-traumatic arthritis, polyarthritis, primary implantation failure). * patients must have received a gmk revision component * patients must be at minimum 2 year (24 months) post-treatment * the operation was performed or supervised by the investigator. * no age limit criteria exclusion criteria: * history of alcoholism * currently on chemotherapy or radiation therapy * habitual use of narcotic pain medications prior to surgery or after surgery for reasons other than knee pain * history of a metabolic disorder affecting the skeletal system other than osteoarthritis or osteoporosis * history of chronic pain issues for reasons other than knee pain * women that are pregnant

Keywords: total knee arthroplasty total knee replacement revision knee arthroplasty
co-infection of ntm in patients with smear positive pulmonary tb

Conditions: Tuberculosis, Pulmonary

Summary: the aim of this study is to elucidate the prevalence of nontuberculous mycobacterial (ntm) co-infection in patients with smear positive pulmonary tb. to detect the ntm co-infection, we will perform duplex pcr targeted for mycobacterial hsp 65 gene using sputa. in addition, the clinical significance of this co-infection will be evaluated.


Eligibility criteria:
inclusion criteria: * new patients with pulmonary tb * sputum afb smear-positivity exclusion criteria: * non-applicable
a phase 3, long-term, extension study of tvp-1012 (1 mg) in early parkinson's disease participants

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the long-term safety of tvp-1012 (1 mg/day) in japanese participants with early parkinson's disease.

this is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety and efficacy of long-term administration of tvp-1012 at 1 mg for another 26 weeks in participants with early parkinson's disease who have completed the preceding tvp-1012/cct-001 (nct02337725) study. among participants of the tvp-1012/cct-001 study, those consenting to participate in this study prior to complete the preceding study and fulfilling the eligibility criteria will be enrolled in this study. from the day after the visit 8 of the preceding study, participants will receive 1 mg of tvp-1012 once daily for 26 weeks in an unblinded manner.

Eligibility criteria:
inclusion criteria: * the participant has completed the preceding study. * the participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator. exclusion criteria: * the participant has undergone blood collection of \>= 400 ml within 90 days prior to the start of treatment in this study. * the participant is required to take any of the excluded medications or treatments. * the participant is required surgery or hospitalization for surgery during the study period.
comparison of insulin detemir or insulin glargine as add on to oral antidiabetic drugs in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe and the united states of america (usa). the aim of the trial is to test if insulin detemir as add-on to current oral antidiabetic drug treatment is at least as effective as insulin glargine as add-on to current oral antidiabetic drug treatment in reducing hba1c in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for more than 12 months, and no previous insulin treatment * oral antidiabetic drug treatment for at least 4 months * body mass index (bmi) less than 40 kg/m2 * hba1c 7.5-10.0% exclusion criteria: * current or previous treatment with thiazolidinediones within the last 6 months * oral antidiabetic drug treatment with combination of three or more oral antidiabetic drugs within the last 6 months * proliferative retinopathy or maculopathy * known hypoglycaemia unawareness
vitamin d status in lower extremity joint replacement surgery patients

Conditions: Hypovitaminosis D

Summary: in the united states, \~1 million elective hip or knee replacement surgeries are performed annually. with estimated surgical site infection (ssi) rates as high as 2.5%, this represents \~25,000 patients at risk of potentially avoidable morbidity following lower extremity joint replacement surgery. although ssis only account for 20% of all hais, they are a major risk factor for prosthetic joint infections (pjis). furthermore, utis have also been identified as an independent risk factor for infections of implanted hardware. in general, the majority of pjis become apparent within 3 months of hardware implantation, but deep infections may not be evident for up to one year after surgery. hardware infections result in delayed healing, repeated surgical interventions, and long-term antibiotic therapy. pjis are associated with an average increase in hospital los by 14 days, additional expenditures of up to $50,000 per infected joint, and a doubling of the mortality rate compared to uninfected lower extremity joint replacements. recent work from our group suggests that vitamin d insufficiency may be a risk factor for perioperative hais. the prevalence of vitamin d insufficiency is approximately 40% in elective joint replacement surgery patients, and perioperative 25(oh)d levels drop 30-40% in the setting of surgical stress, remaining 20% below baseline up to 3 months after surgery. to date, perioperative vitamin d optimization strategies have not been reported. therefore, our goal is to study the effect of a single (pre-operative) versus a divided (pre-operative and on post-operative day 1) dose of cholecalciferol on perioperative vitamin d status in patients scheduled for elective hip or knee joint replacement surgery.


Eligibility criteria:
inclusion criteria: * male or female * age ≥18 years * english or spanish speaking * scheduled for preoperative clinic assessment * scheduled to have elective hip or knee joint replacement surgery * not taking more than 1000 iu of either cholecalciferol or ergocalciferol daily exclusion criteria: * unable to provide consent * inability to comply with study protocol * history of anemia (hematocrit \<25%) * history of renal stones or hypercalcemia * conditions that can cause hypercalcemia (e.g. metastatic cancer, sarcoidosis, myeloma) * medications that affect vitamin d metabolism (e.g. anti-epileptics, tuberculosis medication) * already enrolled or planning to enroll in a research study that would conflict with full participation in the current study or confound the observation or interpretation of the study findings

Keywords: vitamin d perioperative immune regulation ll-37 hospital-acquired infection surgical site infections
immunogenicity and safety of menactra® vaccine in adolescents in saudi arabia

Conditions: Neisseria Meningitidis; Meningococcal Infections

Summary: this study will be conducted among adolescents in saudi arabia who previously received one dose of a, c, y, w 135 and at least one dose of a, c meningococcal polysaccharide vaccine. this study will evaluate the booster administration of menactra® (meningococcal a, c, y, and w 135 polysaccharide diphtheria toxoid conjugate vaccine) compared with mencevax® (meningococcal a, c, y, and w 135 polysaccharide vaccine)in terms of their serum bactericidal antibody responses.


Eligibility criteria:
inclusion criteria: * healthy, as determined by medical history and physical examination. * aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive). * for the menactra® and mencevax® groups, one dose of quadrivalent (a, c, y, w 135) and at least one dose of bivalent (a, c) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment. * for the control group, no previous history of any meningococcal vaccination. * informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old * able to provide a vaccination log or has available vaccination record in the health center * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria: * serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.) * known or suspected impairment of immunologic function. * acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 37.5°c at the time of inclusion. * administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the study vaccine. individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment. * oral or injected antibiotic therapy within the 72 hours prior to vaccination * received any vaccine in the 14-day period prior to study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination. * previous history of documented invasive meningococcal disease. * systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances * participation in another clinical trial in the 4 weeks preceding the trial vaccination * planned participation in another clinical trial during the present trial period * any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine. * personal or family history of guillain barré syndrome. * for female, known or suspected to be pregnant at the time of inclusion

Keywords: n meningitidis
does thinning the blood during surgery prevent blood clots following total knee replacement surgery

Conditions: DVT; Osteoarthritis

Summary: the goal of this study is to prevent blood clots from forming during surgery and a few days after total knee replacement surgery. this study will help us identify whether using a blood thinner in the operating room will stop blood clots from forming during the operation.

venous thromboembolism is a major cause of morbidity and mortality after lower limb orthopaedic surgery in the adult patient. if, as suggested, dvt formation begins intra-operatively then targeting this period to prevent clot formation could substantially reduce dvt rates in the tka population. the present study aims to determine whether this intra-operative regional heparinization technique is effective in preventing the intra-operative formation of dvt following tka, as evidenced by venography in the early post-operative period.

Eligibility criteria:
inclusion criteria: 1. undergoing unilateral primary total knee arthroplasty 2. males and non-pregnant females ages 18-90 (pre-menopausal females will undergo a serum pregnancy test at screening) 3. full weight bearing status (of non-operated leg) following surgery 4. patient able to understand and willing to sign informed consent exclusion criteria: * 1) known hypersensitivity to contrast media 2) patients taking metformin 3) serum creatinine above 180fmol/l 4) platelets \&lt; 100 x 10 9/l, inr/ptt \&gt; 1.5 x normal 5) history of heparin induced thrombocytopenia 6) allergy to heparin or fish 7) prior use of protamine sulfate (i.e., protamine-containing insulin) 8) vasectomized or infertile males 9) history of bleeding disorder 10) bilateral total knee arthroplasty 11) history of stroke or myocardial infarction in previous 6 months 12) traumatic spinal anaesthesia (two or more attempts and/or bloody) 13) history of previous dvt/pe 14) active peptic ulcer disease (e.g., gi bleed, rectal bleed) 15) currently on chronic anticoagulant therapy 16) contra-indication to heparin 17) patient is taking part in any other investigational study 18) previous contralateral tkr or hip replacement

Keywords: dvt osteoarthritis total knee arthroplasty
xelox with capecitabine maintenance or xelox in elderly metastatic adenocarcinoma of stomach

Conditions: Gastric Cancer

Summary: to confirm the efficacy and safety of xelox with capecitabine maintenance in treatment of elderly advanced gastric cancer (agc) by comparing it with that of xelox regimen.

to investigate whether xelox with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as xelox regimen.

Eligibility criteria:
inclusion criteria: * ages eligible for study: 65 years or older * genders eligible for study: both * the eastern cooperative oncology group (ecog) status ≤ 2 * histologically confirmed gastric adenocarcinoma(including lauren type). * measurable disease(according to the response evaluation criteria in solid tumors (recist) criteria 1.1). * chemotherapy naive after recurrence or metastasis. previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months. * hb \> 90g/l, neutrophil count \> or = 1.5\*10\^9/l, platelet \> or = 100\*10\^9/l, alanine transaminase (alt) and aspartate aminotransferase (ast) \ or = 30g/l, serum creatinine \< 1 times uln. * no serious concomitant diseases which could lead to death within 5 years. at least 5 years from the last biological/immunotherapy/hormone treatment for malignancy excluding gastric cancer. * able to accept oral medication * compliance with protocol exclusion criteria: * had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding corticosteroids. * other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix. * uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders. * clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, new york heart association (nyha) ii or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months. * upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine. * organ transplantation requires immunosuppressive treatment. * severe uncontrolled recurrent infections, or other serious uncontrolled concomitant diseases. * moderate or severe renal impairment(creatinine clearance (ccr) = or \ uln. * known enzyme deficiency of dihydropyrimidine dehydrogenase(dpd). * allergy to oxaliplatin or any study medication ingredients.

Keywords: elderly gastric cancer capecitabine maintenance
influence of implant surface decontamination on the reconstructive outcomes of peri-implantitis

Conditions: Peri-Implantitis

Summary: two groups are aimed at being investigated in three centers (cicom, clinica branemark and clinica joan pi) * test group: group electrolytic approach (ea): mechanical detoxification using curettes + niti brushes + ea (galvosurge) during 2 minutes * control group: group hydrogen peroxide (hp): mechanical detoxification using curettes + niti brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze patients´ group selection will be randomly allocated. for patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group. the infra-osseous component will be regenerated using xenograft (creos, nb) + autogenous bone in a ratio 1:1 harvested from the adjacent area. a resorbable membrane (creos, nb) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.


Eligibility criteria:
inclusion: * screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months. * all patients in age of 18 to 80 * non-smokers * no presence of systemic disease or medication known to alter bone metabolism * partial or complete edentulous patients that have no active periodontal disease. exclusion criteria: * pregnancy or lactation * history of or current smokers * uncontrolled medical conditions, * lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites, * advanced(a) peri-implantitis (\>50% of the implant length).
detection of airway obstruction by manometry in different sleep stages and comparing it to dise

Conditions: Sleep Apnea Syndromes

Summary: patients with osa receive manometry measurements with apneagraph (ag) during one night of sleep. all patients are simultaneously evaluated with polysomnography. patients who are not eligible for cpap therapy are additionally studied with drug-induced sleep endoscopy (dise). the frequency and obstructions patterns in different sleep stages are assessed. in addition obstruction patterns detected with ag are compared with dise examination in the selected cases.


Eligibility criteria:
inclusion criteria: * apnea-hypopnea-index (ahi) ≥ 5. exclusion criteria: * age \<18 years; * body mass index (bmi) of \>35 kg/m2; active infection; * previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (\> 60g ethanol per day or \> 150g ethanol per week) or sedatives; illicit drug use; * chronic obstructive pulmonary disease.
comparison of adenoma detection rate with endocuff vision® vs. g-eye®

Conditions: Adenoma; Colorectal Cancer

Summary: the study is intended to compare the detection rate obtained by performing g-eye® high definition colonoscopy vs. the detection rate obtained by performing ecv high definition colonoscopy.

this is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing g-eye® high definition colonoscopy vs. the detection rate obtained by performing ecv high definition colonoscopy.

Eligibility criteria:
inclusion criteria: 1. screening and surveillance population for adenoma and crc. 2. the patient must understand and sign a written informed consent for the procedure. exclusion criteria: 1. subjects with inflammatory bowel disease; 2. subjects with a personal history of hereditary polyposis syndrome; 3. subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. subjects with diverticulitis or toxic megacolon; 5. subjects with prior colonic surgery (exclusion appendectomy) 6. subjects with a history of radiation therapy to abdomen or pelvis; 7. pregnant or lactating female subjects; 8. subjects who are currently enrolled in another clinical investigation. 9. subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. subjects with recent (within the last 3 mounts) coronary ischemia or cva (stroke) 11. any patient condition deemed too risky for the study by the investigator

Keywords: adenoma colorectal cancer