Kornimate/medical-research-clean huggingface dataset:
study to evaluate the effect of two steady state doses of pf 06882961 on rosuvastatin and midazolam pharmacokinetics in otherwise healthy adult participants with obesity

Conditions: Obesity

Summary: a phase 1 study to evaluate the effect of two steady state doses of pf 06882961 on rosuvastatin and midazolam pharmacokinetics in otherwise healthy adult participants with obesity

this study is designed to look at the effect of two doses of pf 06882961 (120 milligram (mg) twice a day (bid) and 200 mg bid) on the levels of one dose of rosuvastatin 10 mg and one dose of midazolam 2 mg, in otherwise healthy, adult participants with obesity. total duration of study from screening to the telephone visit will be approximately 17 weeks, of which up to 63 days will be inpatient. all subjects take (i) rosuvastatin alone, midazolam alone, pf 06882961 alone (120 mg bid), pf 06882961 (120 mg bid) + rosuvastatin, pf 06882961 (120 mg bid) + midazolam, pf 06882961 (200 mg bid) alone, pf 06882961 (200 mg bid) + rosuvastatin, pf 06882961 (200 mg bid)+ midazolam in the study.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at screening. * stable body weight, defined as \<5 kg change (per participant report) for 90 days before screening exclusion criteria: * known prior participation in a trial involving pf-06882961. * known intolerance or hypersensitivity to glp-1r agonists. * known hypersensitivity to rosuvastatin or midazolam. * diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at screening. note: prior diagnoses of gestational diabetes during pregnancy only are eligible if they meet the other eligibility criteria * any lifetime history of a suicide attempt. * blood donation (excluding plasma donations) of approximately 1 pint (500 ml) or more within 60 days prior to dosing. * participation in a formal weight reduction program (eg, weight watchers) within 90 days prior to screening.

Keywords: obesity
remote simultaneous medical interpreting and medical outcomes

Conditions: DIabetes

Summary: all new patients to the general medicine clinic who were not primarily english speaking were randomized, after consenting, to receieve either remote simultaneous medical interpreting or usual and customary interpreting services. patient charts were followed for one year after enrollment to assess medical outcomes, including patient satisfaction, diabetes management, lipid management, depression screening and management, vaccine administration. all spanish-speaking er patients were similarly enrolled. they were followed for one er visit and their knowledge of exit instructions was assessed, as well as their satisfaction with care.


Eligibility criteria:
inclusion criteria: * limited english-speaking * english-speaking * new patient in medicine clinic

Keywords: immigrant interpreting
ceramic versus composite in the treatment of posterior teeth by inlays or onlays

Conditions: Dental Caries; Inlays

Summary: the main purpose of this trial is to determine which material, between ceramic and composite, is best to manufacture dental inlays and onlays in the treatment of moderate dental substance losses, generally due to dental caries. restorations will be done using direct computer assisted design and manufacturing (cad-cam). another aim of this study is to determine which factors influence the success of these restorations.

who estimates dental caries prevalence to be over 90% adults worldwide. when tooth substance loss due to the decayed tissue is small, a filling is done by the dentist directly. when the substance loss is important, dentists often treat it with a crown, which presents the disadvantage of further mutilating the tooth. an intermediate technique consists in manufacturing an inlay or an onlay: these restorations become more and more common since they are a minimally invasive solution in such cases. inlays and onlays can be made of metal, ceramic or composite. patients tend to refuse metallic restorations, so that dentists generally have to choose between composite and ceramic. composite wears whereas ceramics fracture. published in vitro studies provide possible answers to which material is most effective but very few clinical studies have been conducted to confirm them. material\\'s choice for inlay manufacturing is thus more country-based than evidence-based (most french dentists choose composite while us dentists prefer ceramics for example). the main objective of this trial is to compare the clinical performance of ceramic and composite inlays/onlays. other objectives include looking for the prognostic factors of these restorations and validating the criteria proposed by the world dental federation (fdi) to evaluate dental restorations.

Eligibility criteria:
inclusion criteria : * patient aged 18-70,who tolerates restorative procedures and presents a moderate-sized dental caries or restoration (that needs to be replaced) necessitating an inlay/onlay restoration. exclusion criteria : * allergy to one of the materials employed, bruxism, severe or acute periodontal or carious disease, poor oral hygiene * tooth presents a mobility \> ii, a periodontal socket \> 3mm or supports a removable partial denture randomization criterium : * tooth necessitates an inlay-onlay restoration after caries or former restoration removal exclusion from randomization criteria : * subgingival margin after cavity preparation, rubber dam cannot be placed, all tooth cuspids need to be covered by the restoration.

Keywords: dental caries inlays composite resins ips-empress ceramic bicuspid fdi dental restorations evaluation criteria
optimizing clinical outcomes in patients undergoing mitral transcatheter edge-to-edge repair (m-teer) for severe functional mitral regurgitation towards improved guideline-directed medical therapy

Conditions: Mitral Regurgitation Functional; Heart Failure; M-TEER

Summary: a multi-centre, prospective, observational pilot registry in patients undergoing mitral valve repair for severe functional mitral regurgitation to report the heart failure drug therapy and dosing before the mitral valve procedure and afterwards to assess whether the recommended maximal dose of medication is administered. this maximal dose, although recommended, might not be tolerated well by patients and can cause side-effects. researchers will determine whether the mitral valve repair procedure might have a possible effect on increasing the drug therapy towards the recommended optimal doses.

mitral transcatheter edge-to-edge repair (m-teer) has become an important therapy in the management of severe functional mitral regurgitation (fmr). these patients often have left ventricular dilatation with associated left ventricular failure and undergo intervention after guideline-directed medical therapy (gdmt) is optimised. however, many patients cannot tolerate maximal doses of these drugs, some of which are potent vasodilators, due to the potential for hypotension and other side effects. after m-teer, with significant reduction of valve regurgitation, and a consequent improvement in systemic blood pressure and left ventricular function, it may be possible to further optimize gdmt and thus improve patients' clinical outcomes. this pilot registry will be conducted in up to 4 german centres with a minimum annual volume of \~ 50 m-teer procedures aiming for an environment of 100 patients. this registry aims to: * document the extent of suboptimal gdmt in patients undergoing m-teer for severe fmr and to assess the potential to improve care towards maximal recommended medical therapy. * compare 6- and 12-months heart failure (hf) hospitalization post-procedure compared to 12- and 6-months historical hf hospitalisation prior the index procedure. functional status (nyha class, 6-minute walk test) to be assessed at baseline and at 6 months follow-up.

Eligibility criteria:
inclusion criteria: * mitral transcatheter edge-to-edge repair (m-teer) patients treated with the pascal system (≥ 18 years) as per the current approved indication and local heart team decision * severe functional and mixed-type mitral regurgitation with lv-ef \< 50% * patient with optimized guideline-directed medical therapy (gdmt): a minimum of 3 points in the pre-defined gmdt scoring system * provision of written informed consent exclusion criteria: * degenerative mitral regurgitation * emergency procedure * re-do or concomitant (mitral/tricuspid) procedures * patients on maximum dose gdmt * atrial functional mitral regurgitation (fmr) * coronary revascularisation within the last 3 months * pregnant woman

Keywords: mitral regurgitation heart failure m-teer optimizing gdmt functional mitral regurgitation
the effect of shr20004（noiiglutide ） on body weight in obese subjects without diabetes

Conditions: Obesity

Summary: the study is being conducted to assess the efficacy and safety of shr20004 on body weight in obese subjects without diabetes.


Eligibility criteria:
inclusion criteria: 1. informed consent obtained prior to any trial-related activities 2. body mass index (bmi) between 28 and 40 kg/m2(both inclusive) 3. diet and exercise management for at least 3 months before screening and less than 5% change in body weight during the previous 3 months（self-reported）. exclusion criteria: 1. history of endocrine disease or treatment that may significantly affect body weight prior to screening visit 2. history of diabetes 3. personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (men2) 4. history of pancreatitis 5. previous surgical treatment of obesity 6. screening calcitonin of 20 ng/l or above
the effect of deep neuromuscular blockade on postoperative shoulder tip pain after laparoscopic cholecystectomy

Conditions: Pain, Postoperative

Summary: the purpose of this study was to investigate whether there is any difference in incidence of shoulder tip pain after laparoscopic cholecystectomy between the groups with moderate neuromuscular block and deep neuromuscular block.

laparoscopic cholecystectomy has become the gold standard treatment for gall bladder disease. however, 30-50% of patients suffer from shoulder tip pain, which might arise from diaphragm stretch due to pneumoperitoneum. in the previous pilot study, working intra-abdominal space was increased in the condition of deep neuromuscular blockade. and thus investigators hypothesized that the depth of neuromuscular blockade can affect insufflation pressure and intra-abdominal volume, which result in the severity of diaphragm stretch and postoperative shoulder pain. in addition, the depth of neuromuscular blockade can alter pulmonary compliance.

Eligibility criteria:
inclusion criteria: * physical status by american society of anesthesiology; 1 or 2 patients * patients with benign gallbladder disease scheduled for laparoscopic cholecystectomy exclusion criteria: * patient with myasthenia gravis * allergy to rocuronium or sugammadex * patient with shoulder pain disease (ex. rotator cuff tear) * psychological disease * patients who cannot understand korean

Keywords: pain, postoperative neuromuscular blocking agents laparoscopy
hereditary tubulointerstitial nephritis

Conditions: Nephritis, Interstitial; Chronic Renal Failure; Gout; Renal Cysts

Summary: the aim of this study is to identify families with hereditary chronic tubulointerstitial renal diseases , characterize the phenotype and screen for mutations in known genesis (umod, ren, tcf2, nphp1). genome wide analysis will be performed in families without mutations identified.

* inclusion of affected subjects with familial history of chronic renal failure, early gout ,renal cysts in several hospital in france * characterization of the phenotype; dosage of the urinary uromodulin in all subjects * collect dna samples * screen for umo mutations first * then for ren or tcf2 depending on the phenotype * validate the use of the dosage of urinary uromodulin for the diagnosis of umod associated disease. * identify new genes responsible for hereditary htin (hereditary tubulointerstitial nephritis).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years. * htin of unknown cause * chronic renal failure defined by a egfr (estimated glomerular filtration rate) estimated according to mdrd (modification of the diet in renal disease) \< 60ml / min / 1,73m2. * at least two siblings affected by gout before 40 years or by chronic renal failure. * affiliated or benefiting from a national insurance * signature of the enlightened consent. exclusion criteria: * endstage renal failure before the age of 18 years in all affected subjects of the family. * microscopic or macroscopic persistent hematuria, or proteinuria \> 1gramme / 24hours. * other potential cause of tin (tubulointerstitial nephritis): pyelonephritis, drug toxicity. * high blood pressure known for more than 10 years before the discovery of the renal disease. * major cardiovascular before the discovery of the renal disease. * chronic auto-immune or infectious disease. * polycystic kidney disease with increased of the size of the kidneys

Keywords: tubulointerstitial renal diseases hereditary renal diseases uromodulin renin gene
increasing detection of sub-clinical atrial fibrillation in defibrillator patients with the use of a vdd-icd lead

Conditions: Cardiac Arrhythmias; Atrial Fibrillation and Flutter; Cardiovascular Diseases; Implantable Cardioverter-Defibrillators

Summary: this study aims to compare the dx-icd system (experimental) to standard vvi-icd (control) on the ability to diagnose silent af in patients without prior af receiving an icd for standard indications.

recipients of implantable defibrillators (icd) are at high risk of developing both af and stroke, given the presence of multiple cardiovascular risk factors. oral anticoagulation can prevent most strokes in patients with af; provided that af is recognized before a stroke occurs. up to about 40% of incident af may be sub-clinical, producing minimal or no symptoms, or being too short to allow detection. dx af is a prospective, randomized-controlled, open-label trial. patients who are identified on clinical grounds for a single-chamber icd will be randomized to a vdd icd (experimental group) or single chamber icd (control group). the study will compare the dx-icd system (experimental) to standard vvi-icd (control) on the ability to diagnose silent af in patients without prior af receiving an icd for standard indications.

Eligibility criteria:
inclusion criteria: * patients with ischemic or non-ischemic cardiomyopathy, * lvef\<50%, scheduled for primary or secondary prevention icd * treating physicians feel that the use of single chamber icd is appropriate * no ecg-documented history of af or flutter * age \> 50 years exclusion criteria: * known af or flutter * current use of class i or iii anti-arrhythmic medications * participants unwilling to attend study follow-up visits, considered unreliable for compliance or with an anticipated life expectancy less than 3 years

Keywords: single-chamber icd (implantable cardioverter-defibrillator) cardiac arrhythmias atrial fibrillation atrial flutter stroke
topography-guided customized prk versus q-value adjusted prk in correction of myopia with or without astigmatism

Conditions: Myopia

Summary: this study will include patients who will undergo prk in both eyes, for each patient each eye will be randomly allocated to one of 2 procedures: topography-guided ablation in one eye (group i) and q-factor customized ablation in the other eye (group ii). alcon/wavelight light laser technolo¬gie (gmbh, erlangen, germany) will be used for photoablation. the wavelight topolyzer (wavelight ag, erlan¬gen, germany)and cso sirius scheimpflug camera combined with placido corneal topography (cso, florence,italy) will be used before and 1, 3 and 6 months after prk. refrac¬tive visual outcomes and corneal aberration changes will be compared between the two treatment modalities.


Eligibility criteria:
inclusion criteria: * age more than 18 years * myopia with up to -6.5 d with or without astigmatism up to -4.75 d exclusion criteria: * anterior segment abnormalities (ie, cataracts, corneal scarring) * basement membrane disease * history of recurrent corneal erosions * schirmer's test less than 5 mm * established or forme fruste keratoconus * macular or retinal disease * current use of immunosuppressive therapy * autoimmune disease * pregnancy, and lactation
maintenance of antiplatelet therapy in patients with coronary stenting undergoing surgery

Conditions: Coronary Disease

Summary: the monet registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure. the effects of the application of the consensus document "stent and surgery-2" on perioperative antiplatelet therapy will be assessed. the study will also assess ischemic and hemorrhagic events in relation to the application of the consensus document and length of any antiplatelet discontinuation and delay in performing surgical procedures.

the monet registry will include any patient with previous coronary stenting undergoing any type of surgery or operative endoscopic/endovascular procedure at the participating centers. centers will be divided into two groups: centers that routinely follow the recommendations of the sas 2 document and centers that do not. the relevant clinical, procedural and outcome data (within index admission and at 30 days) will be entered in a specifically designed electronic case record form (ecrf). the primary endpoint will be the rate of discontinuation of p2y12 inhibitors and/or aspirin (without bridging) in the first 3 months after pci with low risk characteristics and 6 months after pci with high risk characteristics or any antiplatelet therapy discontinuation without bridging therapy. the secondary end-point will be the composite of death, myocardial infarction, probable/definite stent thrombosis and bleeding events at 30 days; the type and the length of discontinuation of any antiplatelet therapy in patients undergoing surgery according to time from pci to surgery; delay in performing surgical procedure; rate of surgical procedures within 12 months from pci divided into quartiles (0-3, 3-6, 6-9, 9-12 months).

Eligibility criteria:
inclusion criteria: * eligible will be male and female patients \> 18 years of age. * eligible will be patients with previous coronary stenting undergoing any kind of surgical or operative endoscopic procedure at the participating centers, irrespective of the distance in time between stenting and surgery. * both candidates to elective and urgent/emergent surgical procedures will be included in the monet registry. exclusion criteria: * unwillingness/inability to sign the informed consent form (icf). patients with an active bleeding requiring discontinuation of one or both antiplatelet agents will be also excluded. there are no other exclusion criteria.
gm-csf, sargramostim in women with recurrent ovarian cancer

Conditions: Ovarian Cancer; Fallopian Tube Cancer

Summary: granulocyte macrophage colony-stimulating factor (gm-csf) is an immunostimulant and preliminary data suggests it may change the natural history of prostate cancer and melanoma. this study looks at ability of gm-csf to alter disease progression in women who have recurrent but asymptomatic recurrence of their ovarian cancer.

this is an open labeled, single arm phase ii study of gm-csf, sargramostim delivered daily without a break in a population of healthy and fit women with evidence of recurrent but asymptomatic mullerian malignancy (such as ovarian cancer, fallopian tube cancer, or primary peritoneal cancer). the main goal is to determine the time to treatment termination due to disease progression or toxicity.

Eligibility criteria:
inclusion criteria: * patients must have a history of histologic or cytologic diagnosis of primary ovarian, primary peritoneal or tubal carcinoma. * patients must be asymptomatic from their cancer. * patients must have evidence of recurrent carcinoma, as determined by: * a rising cancer antigen 125 (ca-125) serum level greater than 35 u/ml or two successive rising values with the most recent value at least 3 times the nadir value. * or evidence of evaluable or measurable disease by x-ray or computed tomography (ct) scan. * patients may not receive concurrent antineoplastic therapy. all hormonal therapy used as a treatment modality (i.e. tamoxifen, arimidex, etc) must be stopped prior to treatment on protocol. * age \> 18 years. * eastern cooperative oncology group (ecog) performance status \< 2. exclusion criteria: * known severe hypersensitivity to gm-csf. * other coexisting malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or concurrent superficial or stage ib endometrial carcinoma. * concomitant use of anti-neoplastic therapy. * treatment with a non-fda approved or investigational drug within 30 days before day 1 of trial treatment. * any unresolved chronic toxicity greater then common toxicity criteria (ctc) grade 2 from previous anticancer therapy (except alopecia). * serum creatinine level greater than ctc grade 2 \[1.5 x upper limit normal (uln)\]. * pregnancy or breast feeding (women of childbearing potential). * severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) as judged by the investigator. * significant clinical disorder or laboratory finding that makes it potentially unsafe for the subject to participate in the trial as judged by the investigator. * patients currently receiving other investigational antineoplastic agents, on systemic chemotherapy or under radiation therapy treatment. * patients with clinical and/or radiographic evidence of current or impending bowel obstruction. * performance status \< 1. * ability to understand and the willingness to sign a written informed consent document.

Keywords: asymptomatic clinical trial phase ii gm-csf immunotherapy