Kornimate/medical-research-clean huggingface dataset:
safety and performance of the suturefix ultra and suturefix curved suture anchors in shoulder and hip arthroscopic repair

Conditions: Instability, Joint

Summary: the scientific justification is to fulfill post-market clinical requirements in order to support re-certification of the ce-mark for this marketed product and to look into safety and efficacy.

shoulder: the superior labrum (fibrous cartilage) and biceps anchor improve joint stability by acting like a secondary stabilizer to the shoulder. labral injuries are usually associated with anterior shoulder dislocation. when conservative treatment fails, such as physical therapy, strengthening programs, anti-inflammatories and activity modification to improve symptoms, surgical intervention may be required. surgical treatments can include simple debridement, stabilization of the biceps-labrum complex through repair, or biceps tenodesis where the end of a tendon is joined surgically to the bone. outcomes of slap (superior labral tear from anterior to posterior) repairs have been reported good throughout the literature, with reported success rates ranging from 71-97%. hip: the labrum of the hip is a fibrocartilaginous tissue that connects to the bone edge of the acetabulum (the socket of the hip bone), and deepens the acetabular socket while extending coverage of the femoral head; it also aids in hip stabilization. the goal of surgical intervention is to restore normal hip mechanics and treat existing damage.

Eligibility criteria:
inclusion criteria: * subject has consented to participate in the study by signing the ec-approved informed consent form * subject condition meets proposed indication to suturefix ultra and suturefix curved suture anchor * subject requiring shoulder or hip arthroscopic labral repair surgery from physical findings, subject symptoms and radiographic finding * hip subjects only: * fai (femoroacetabular impingement) * shoulder subjects only: * subject with a history of recurrent dislocation/subluxation of the shoulder exclusion criteria: * participation in the treatment period of another clinical trial within thirty (30) days of visit 1 (pre-operative) * women who are pregnant, nursing, or of child-bearing potential who are not utilizing highly effective birth control measures * contraindications or hypersensitivity to the use of the suturefix ultra and/or suturefix curved suture anchor, or their components (e.g. silicone, polyester). where material sensitivity is suspected, appropriate tests should be performed and sensitivity ruled out prior to implantation * pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation * pathological conditions in the soft tissues to be attached that would impair secure fixation by suture * comminuted bone surface, which would compromise secure anchor fixation * hip subjects only: * dysplasia latera/central less than 20° * shoulder subjects only: * glenoid and/or humeral bone loss considered excessive by the treating orthopaedic surgeon

Keywords: suturefix hip instability shoulder instability
safety study of nebulized rns60 to treat asthma.

Conditions: Asthma

Summary: the purpose of this study is two-fold. first, to determine whether nebulized rns60 is safe in healthy human subjects and in subjects with mild asthma, in a single-dose administration. second, to determine whether nebulized rns60 is safe in human subjects with mild-to-moderate asthma over a 4-week period.


Eligibility criteria:
inclusion criteria: for single-dose safety (groups 1a and 1b): 1. male or female, aged 18 to 65 years. 2.1. for healthy subjects; clinically considered "healthy" and no diagnosis of asthma. 2.2. for subjects with mild asthma, clinical diagnosis of mild chronic asthma as determined by national heart, lung, and blood institute's (nhlbi) 2007 guidelines, and who are not regularly using a chronic asthma medication (\< 3 doses/week). 3. subjects must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent. 4. women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry. for multi-dose safety study (group 2e): 1. male or female, aged 18 to 65 years. 2. patients with clinical diagnosis of mild to moderate asthma, as determined by nhlbi 2007 guidelines, who are not already using a chronic asthma medication. 3. historical documentation of asthma in the patient's medical record. 4. men and women of reproductive potential who document use of adequate contraception during the study and for 1 month following the last day of treatment (day 28). 5. women of childbearing potential who have a negative pregnancy test (serum) at the time of study entry. 6. subjects, or their legal guardians, must be capable of understanding the purpose and risks of the study and provide written, voluntary informed consent. exclusion criteria (for all groups of the study): 1. with a chronic or acute disease that might interfere with the evaluation of rns60 therapy. 2. pregnancy or lactation. 3. current or prior malignancies (excluding non-melanoma skin carcinoma or carcinoma in situ of the cervix that has been adequately treated). 4. history of infection with human immunodeficiency virus (hiv-1), hepatitis b virus (hbv), or hepatitis c virus (hcv); or hepatitis a virus (hav). 5. infections that require intravenous antibiotic therapy. 6. significant organ dysfunction, including cardiac, renal, liver, cns, pulmonary, vascular, gastrointestinal, endocrine, or metabolic (e.g., creatinine ≥ 1.6 mg/dl; alt or ast ≥ 1.5x the upper limit of normal; history of myocardial infarction, congestive heart failure, or arrhythmias within 6 months prior to study entry). 7. treatment with a humanized or chimeric antibody therapy within 4 weeks prior to study entry. 8. treatment with any investigational drugs or therapies within 4 weeks prior to study entry. 9. any use of antidepressants or other psychiatric medicine in the previous 4 weeks days. 10. group 1b: any use of oral, systemic corticosteroids within 2 weeks prior to enrollment. group 2e: any use of oral, systemic corticosteroids within 4 weeks prior to enrollment.
influence of insulin on bp change during adolescence

Conditions: Cardiovascular Diseases; Hypertension; Obesity; Insulin Resistance; Diabetes Mellitus

Summary: to define the relation of insulin resistance during childhood and adolescence to the development of the insulin resistance syndrome in young adulthood.

background: the insulin resistance syndrome (irs) is associated with a considerable increase in the risk of cardiovascular disease in adults. the disorder most likely is inherited to some degree with onset in childhood and early adolescence. the irs is best defined by quantitative data from euglycemic insulin clamp studies. the investigators have developed a unique data base in children, and by continuing repeated studies and follow-up in early adulthood together with studies in parents and siblings this study should provide important insight into the occurrence and progression of cardiovascular disease in later life. design narrative: the study is designed to: 1) define the relation of insulin resistance during childhood and adolescence to the development of insulin resistance syndrome (hypertension, dyslipidemia, obesity, and insulin resistance) in young adulthood; and 2) define the relation of insulin resistance within families. the original cohort consists of 357 children who have had two euglycemic insulin clamp studies (at mean ages 13 and 15 years). the specific aims are: to (1) repeat anthropometric and blood pressure measurements at mean ages 18, 19, and 20 and obtain insulin clamps, lipid levels, echocardiograms, and dexa at mean age 21 in the children; and (2) obtain the measurements, blood and dna samples, echocardiogram, and insulin clamp in the parents and siblings of the children. statistical genetics methods are used to estimate heritability and genetic correlations among the insulin resistance syndrome traits. these data address the hypotheses that 1) insulin resistance in childhood predicts insulin resistance and cardiovascular risk factors in young adulthood; 2) insulin resistance in parents is associated with insulin resistance and cardiovascular risk factors in their children; 3) in fat children, bmi and insulin resistance at mean age 13 predicts cardiovascular risk, but in thin children only insulin resistance is a similar predictor; 4) insulin resistance has significant heritability; and 5) there are significant genetic correlations between insulin resistance and the insulin resistance traits. at least 300 of the original cohort of 357 who have had two euglycemic insulin clamps continue on in the study. the study continues through july, 2008.

Eligibility criteria:
no eligibility criteria
impact of exenatide on sleep in type 2 diabetes

Conditions: Type 2 Diabetes; Sleep Disordered Breathing

Summary: the investigators propose a pilot study to test the novel hypothesis that exenatide treatment in patients with type 2 diabetes results in improved sleep duration and quality and to explore the relationship between improvements in sleep and measures of metabolic and circadian function. this project would be the first to probe the relationship between incretin hormone regulation, duration and intensity of sleep, glucose tolerance and circadian dysfunction in diabetic patients.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of t2dm based on physician documentation according to established guidelines will be eligible. exclusion criteria: * patients with unstable cardiac, neurological or psychiatric disease * women who are pregnant or report trying to get pregnant will be excluded. * patients treated for obstructive sleep apnea (osa) will be excluded. * patients with established osa will be included only if they have declined treatment of osa. * patients with morbid obesity (bmi ≥ 40 gk/m2) * patients on insulin * patients already taking an incretin-based drug will not be included * patients with renal disease (creatinine clearance \<30 ml/min), gastroparesis and history of pancreatitis will also be excluded based on known possible adverse medication side effects. * patients taking an insulin secretagogue will be excluded. * patients with hemoglobin a1c values greater than or equal to 10 will be excluded.

Keywords: slow wave sleep exenatide and sleep
peritoneal dialysis registration system (persist)

Conditions: ESRD; Disorders Associated With Peritoneal Dialysis

Summary: brief summary: the investigators are registering all pd patients at recruited hospitals and developing a pd database in china. patients will be followed up every 3 months, and both baseline and follow-up information will be collected and input into the registration system. the patient survival, technical survival, peritonitis rate, longitudinal changes of residual renal function and peritoneum function, and quality of life for pd patients, etc, will be compared using the pd database.

detailed description: the investigators are registering all end stage renal disease (esrd) patients receiving peritoneal dialysis (pd) treatment, and developing a pd database in china. patients' demographic characteristics (including age, gender, height, weight, bmi, smoking, drinking, and education, etc), clinical characteristics (primary cause of esrd, dialysis prescription, patient's condition and lab measurements of serum, urine, and dialysate), drug information, complications and scores of quality of life at the baseline will be collected. patients will be followed up every 3 months. demographic and clinical characteristics, complications, drug information of patients will be collected at each visit. the patients' clinical outcomes, such as mortality (including all-cause mortality and cardiovascular disease mortality), technical survival, kidney transplantation, transfer to hemodialysis, hospitalization, occurrence of peritonitis, etc. were also followed up till the end of the study. the data of patient survival, technical survival, peritonitis rate, hospitalization rate, clinical lab parameters, longitudinal changes of residual renal function and peritoneum function, peritonitis rate, hospitalization rate, clinical lab parameters and quality of life for pd patients will be analyzed using the pd database.

Eligibility criteria:
inclusion criteria:pd patients - exclusion criteria:no -

Keywords: peritoneal dialysis (pd) residual renal function peritoneum function peritonitis rate technical survival patient survival
biomarkers in predicting response in patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer treated on gog-0172 or gog-0182

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Peritoneal Cavity Cancer

Summary: rationale: studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how well patients will respond to treatment. purpose: this research study is looking at biomarkers in predicting response in patients with advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.

objectives: primary * to evaluate ercc1 tumor expression, as measured by ihc, as a predictor of progression-free and overall survival of patients with advanced ovarian epithelial cancer. secondary * to correlate ercc1 single-nucleotide polymorphisms (c8092a and codon 118) with ercc1 tumor expression. outline: this is a multicenter study. blood and paraffin-embedded tumor tissue samples are analyzed for ercc1 tumor expression by ihc and single-nucleotide polymorphisms.

Eligibility criteria:
disease characteristics: * histologically confirmed advanced invasive ovarian epithelial carcinoma, fallopian tube adenocarcinoma, or primary peritoneal carcinoma * has undergone optimal surgical staging * has received chemotherapy on either gog-0172 or gog-0182 * adequate blood or dna available for ercc1 analysis * adequate tumor on paraffin-embedded tissue for ihc staining patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent ovarian epithelial cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer
randomised prospective trial comparing contact force and non-contact force guided catheter ablation for cavotricuspid isthmus dependent atrial flutter

Conditions: Atrial Flutter; Radiofrequency Catheter Ablation

Summary: radiofrequency ablation (rfa) is a standard treatment option for cavotricuspid isthmus (cti) dependent atrial flutter. we plan to perform a randomized prospective trial comparing the efficacy of contact force (cf) guided cti ablation against catheter ablation with the operator blinded to contact force parameters.

subjects will be followed for one year post procedure in order to check for atrial flutter recurrences. this will involve an in-person visit at 3 months post procedure, and records checks at 12 months post procedure.

Eligibility criteria:
inclusion criteria: * adult patients (over the age of 18) with 12 lead ecg documented paroxysmal or persistent cti dependent atrial flutter planned to undergo cti ablation. * able and willing to give informed consent. exclusion criteria: * previous cti ablation * previous non-cti dependent atrial flutter (ie.patients with previous history of pulmonary vein isolation or left atrial ablation, congenital heart disease, surgical ablation)
adipokines and the risk of reflux esophagitis

Conditions: Visceral Obesity; Reflux Esophagitis

Summary: we aimed to risk faoctors for gerd and association between visceral obesity, plasma adipoline(leptin, adiponectin, il-6, tnf-α)and development of reflux esophagitis in healthy koreans.


Eligibility criteria:
inclusion criteria: * endoscopically proven reflux esophagitis exclusion criteria: * those with esophageal hiatal hernia, current ppi medication, upper gi operation history

Keywords: gerd reflux esophagitis adipokine especially endoscopically proven
study evaluating effects of sam-531 on sleep electroencephalogram (eeg) and quantitative wake eeg in healthy subjects

Conditions: Healthy; Adult

Summary: primary: to evaluate the pharmacologic effect of single doses of sam-531 on sleep eeg in healthy subjects.


Eligibility criteria:
inclusion criteria: * men or women of non-childbearing potential aged 18 to 50 years inclusive on study day 1. * body mass index in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg. * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital sign measurements, and 12-lead electrocardiogram. exclusion criteria: * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, hematologic, neurologic, or psychiatric disease. * clinically significant abnormal standard eeg at screening. * consumption of any caffeine-containing products or alcoholic beverages within 48 hours before study day 1.

Keywords: alzheimer disease
study of lx1031 in subjects with non-constipating irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of the study is to evaluate the safety, tolerability, and effectiveness of lx1031 versus a placebo control in subjects with non-constipating irritable bowel syndrome.


Eligibility criteria:
inclusion criteria: * males and females aged 18-70 years old * documented diagnosis of ibs (ibs-diarrhea or ibs-mixed) based upon rome iii criteria * abdominal pain/discomfort at least 2 days per week during the screening and run-in periods * normal structural evaluation of the colon within 5 years prior to screening * ability to provide written informed consent exclusion criteria: * inability to discontinue current drug therapy for ibs, except for bulking agents, through the duration of the study * use of anticholinergic antidepressants, opioid pain medications, or any drugs that affect bowel motility * lactose intolerance * major psychological disorder * significant nicotine or caffeine use (\>10 cigarettes and/or six 8 ounce cups of coffee per day, respectively)
trial and cost effectiveness evaluation of intra-arterial thrombectomy in acute ischemic stroke

Conditions: Cerebral Stroke; Cerebrovascular Accident

Summary: thrace is a controled, multicenter and randomized trial. the primary objective of this study is to determine whether a combined approach intravenous thrombolysis (iv) + mechanical thrombectomy is superior to the reference treatment with iv thrombolysis alone, in the 3 hours of onset of symptoms in patients with occlusion of proximal cerebral arteries and with a neurological impairment accident (national institutes of health stroke scale \[nihss\] ≥ 10). the second objective is to determine the cost-effectiveness of this procedure compared to the standard (iv thrombolysis). the assumption is that the combined approach, by improving the clinical outcome and speed recovery, allows for lower overall costs to the iv thrombolysis in 3 months and less than or at worst neutral to 1 year.


Eligibility criteria:
inclusion criteria: * 10\<=nihss score=\<25 * symptoms onset less than 4 hours * occlusion of the intracranial carotid, the middle cerebral artery (m1) or the upper third of the basilar exclusion criteria: * contraindications for intravenous thrombolysis * occlusion or stenosis of the pre-occlusive cervical internal carotid artery ipsilateral to the lesion * any cause local prohibiting femoral catheterization

Keywords: mechanical thrombectomy cva (cerebrovascular accident) cerebrovascular accident, acute
a 12-week, randomized, double-masked, parallel group comparison of evening dosing with xalacom in subjects with glaucoma

Conditions: Open Angle Glaucoma; Ocular Hypertension

Summary: to demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 am, 10 am, 4 pm at weeks 2, 6 and 12.


Eligibility criteria:
inclusion criteria: * uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening exclusion criteria: * closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. * history of alt (argon laser trabeculoplasty) or slt(selective laser) within 3 months prior to screening
manual implantation of full-thickness skin microcolumns

Conditions: Wound of Skin; Burns

Summary: the objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (ftsms) as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

previously three patients have been successfully treated with the use of manual ftsm for wound coverage. to provide additional proof of concept data, this study will validate manual ftsm implantation on a larger scale with a 10-patient population. this will be measured by the following hypothesized parameters: time to re-epithelization, pigmentation, wound contraction, scar thickness, pain at the donor site and injury site healing outcome. the approach to testing this hypothesis will be to perform manual ftsm harvest, placement on the injured site, covered by an inert dressing for 10 patients with open wounds necessitating tissue coverage. the rationale is that although preliminary proof of concept data has already been obtained from three patients treated with ftsm implantation, additional proof of concept data would strengthen the conclusions made based on these cases.

Eligibility criteria:
inclusion criteria: * 8-85 years of age * 10-125 cm2 open wound on the scalp, neck, torso or extremities necessitating tissue coverage * sufficiently healthy skin to serve as a donor site exclusion criteria: * wound area involving the face\* * wound area involving joints\* * pregnancy * prisoner * active wound infection at potential treatment sites * exposed muscle, joint, tendon, or bone within the wound bed
a study comparing the efficacy & safety of torcetrapib/atorvastatin and atorvastatin in subjects with high triglycerides

Conditions: Hypertriglyceridemia; Hyperlipoproteinemia Type IV

Summary: the torcetrapib project was terminated on december 2, 2006 due to safety findings. to assess the safety and efficacy of the fixed combination torcetrapib/atorvastatin in subjects with fredrickson type iv hypertriglyceridemia.

for additional information please call: 1-800-718-1021

Eligibility criteria:
inclusion criteria: * diagnosis of fredrickson type iv hypertriglyceridemia exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant. * subjects with a clinically indicated need for statin (hmg-coa reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on ldl-c and hdl-c including fibrates and nicotinic acid * subjects taking any drugs known to be associated with an increased risk of myositis in combination with hmg-coa reductase inhibitors * subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study