Kornimate/medical-research-clean huggingface dataset:
barbed-suture efficiency study for sacrocolpopexy

Conditions: Prolapse; Female

Summary: minimally invasive sacrocolpopexy (scp) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. one of the time consuming parts of the procedure is vaginal mesh attachment.

the purpose of this research study is to compare two different suture types that are used to attach vaginal mesh that is typically used in women undergoing robotic or laparoscopic sacrocolpopexy (attachment of the vagina to the sacral promontory). the barbed suture is one continuous suture, while the delayed absorbable suture involves placing individual sutures and tying a knot for each. all women will have permanent sutures that attach the mesh to the sacral promontory, which is standard of care. the goal is to determine if the barbed delayed absorbable suture decreases the time of vaginal mesh attachment.

Eligibility criteria:
inclusion criteria: * age ≥21 * subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen * subject reports a bothersome bulge they can see or feel per pelvic floor disability index (pfdi-20), question 3, response of 2 or higher * eligible for laparoscopic or robotic sacrocolpopexy * desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse * english speaking exclusion criteria: * patients who are not surgical candidates due to medical comorbidities * current foreign body complications (including but not limited to erosion, fistula, abscess). this covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft). * inability to give informed consent or to complete the testing or data collection. * anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.). * active systemic infection including any gynecologic infection, untreated urinary tract infection (uti) or tissue necrosis. * history of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical). * prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area. * subject has taken systemic steroids (within the last month, steroid inhalers ok), or immunosuppressive or immunomodulatory treatment (within the last 3 months) * systemic connective tissue disease (e.g. scleroderma, marfan's syndrome, ehlers danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus) * chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis * poorly controlled diabetes mellitus (dm), as indicated by hemoglobin a1c \> 9 * those requiring concomitant rectopexy * subject is not able to conform to steep trendelenburg position * known sensitivity to polypropylene * history of prior prolapse repair utilizing vaginal or abdominal mesh * planned vaginal mesh attachment placed transvaginally * history of diverticulitis

Keywords: sacrocolpopexy pelvic organ prolapse vaginal mesh attachment
safety study of cdp7657 in patients with systemic lupus erythematosus

Conditions: Immune System Diseases; Autoimmune Diseases; Lupus Erythematosus, Systemic; Skin and Connective Tissue Diseases; Connective Tissue Disease

Summary: to evaluate safety, tolerability pharmacokinetics and immunogenicity of cdp7657.


Eligibility criteria:
inclusion criteria: * patients with systemic lupus erythematosus (sle) exclusion criteria: * severe neuropsychiatric or severe renal systemic lupus erythematosus (sle) * history of chronic, recurrent, or recent severe infection * significant hematologic abnormalities * history of cancer, heart failure, renal disease, liver disease or other serious illness

Keywords: lupus sle
syncope: pacing or recording in the later years

Conditions: Syncope; Heart Block; Conduction Disorder of the Heart

Summary: syncope affects about 50% of canadians, is the cause of 1 - 2% of all emergency room visits, and probably is responsible for cdn $250 million in health care spending each year. it is associated with decreased quality of life, trauma, loss of employment, and limitations in daily activities. it is a particular problem for older people, partly because of increased frailty, and partly because of a difficult differential diagnosis. one of the causes in older adults is intermittent complete heart block in the setting of bifascicular heart block, but they may also faint due to a variety of tachyarrhythmias, sick sinus syndrome, and several neurally mediated syncopes. often treatment decisions should be made before the true cause is apparent.

there are two general approaches to the patient with syncope and bifascicular block, a common substrate for intermittent heart block. the first is to assume that intermittent heart block is the cause, and simply implant a pacemaker. the second is to implant a digital ecg loop recorder with a lifespan of 2 - 3 years, determine the rhythm abnormalities during the next faint, and treat accordingly. both approaches expose patients to a risk of fainting and its sequelae, and both carry device-related complications.which approach is superior is unknown.

Eligibility criteria:
inclusion criteria: -patients are eligible if they have: * \>1 syncopal spell within 1 year preceding enrollment, and * bifascicular block on a 12-lead ecg, and * age \> 50 years and * written informed consent. syncope will be defined based on history using a standardized form. exclusion criteria: -patients will be excluded if they have criteria related to study strategies, including: 1. previous pacemaker, icd, or implantable loop recorder in situ, 2. acc/aha/hrs class i indication for permanent pacing or icd implantation, 3. left ventricular ejection fraction \< 35% mandating icd therapy, 4. contra-indication to a transvenous pacemaker such as artificial tricuspid valve or active sepsis. -patients will also be excluded if a potential competing cause of syncope poses a threat to life, such as: 5. hypertrophic cardiomyopathy, 6. documented sustained ventricular tachycardia or 7. inducible, sustained monomorphic ventricular tachycardia on ep study. -they will be excluded if they have: 8. a history of myocardial infarction within 3 months prior to enrollment, and 9. a major chronic co-morbid medical condition that would preclude 24 months of follow-up.

Keywords: syncope fainting implantable loop recorder pacemaker heart block bifascicular heart block
the study to evaluate efficacy and safety of celecoxib capsule in hand osteoarthritis patients

Conditions: Osteoarthritis Hand

Summary: the purpose of this study is to evaluate efficacy and safety of celecoxib capsule in hand osteoarthritis patients.

this is a six-weeks, open-label, multi-center, randomized study. patients take celecoxib 200mg capsule once a day or celecoxib 100mg capsules twice per day. if patients do not tolerate the pain, they are able to take acetaminophen as a rescue medication during 6 weeks.

Eligibility criteria:
inclusion criteria: * agreement with written informed consent and 19 years of age and older * patients history of oa of hand according to acr criteria * the 100mm pain vas is over 40mm exclusion criteria: * history of oa of hand surgery * intra-articular injections within 3 months * history of oa of hand infections within 3 months * who had taken a drug that has a control of result in clinical trial by investigator's decision * pregnant women, nursing mothers or fertile women who not practice contraception with appropriate methods * clinically significant hepatic, renal, cardiovascular diseases * any history of adverse reaction to the study drugs * patients with gastrointestinal ulcers or bleeding disorders * finger joint injury within 6 months * who had following results after examination 1. k ≥ 5.5meq/l 2. egfr ≤ 30ml/min/1.73m\^2 * patients on any other clinical trial or experimental treatment in the past 3 months * taking narcotic analgesics or patches * history of drug abuse or alcoholism * who has galactose intolerance, lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders * an impossible one who participates in clinical trial by investigator's decision

Keywords: osteoarthritis hand
is laparoscopic excision for peritoneal endometriosis helpful or harmful?

Conditions: Endometriosis; Peritoneum

Summary: the trial seeks to test effect of laparoscopic excision of peritoneal endometriosis on pelvic pain. data will also be gathered on quality of life and neuropathic pain. patients will be randomized to one of three groups: 1) laparoscopy with excision of endometrial tissue, 2) laparoscopy without excision of endometrial tissue and 3) waiting list control.


Eligibility criteria:
inclusion criteria: * adult (≥ 18 years) with suspected peritoneal endometriosis undergoing elective surgery for pain relief * pain intensity ≥ 5 on numeric rating scale (nrs) in the four weeks prior to giving consent exclusion criteria: * other known conditions/diseases that may cause pelvic pain * diagnosed personality disorder, schizophrenia or treatment with anti-psychotics * planned pregnancy during study period * women who cannot read or speak danish

Keywords: pelvic pain quality of life post-surgical neuropathic pain endometriosis surgery
the impact of preoperative olanzapine on quality of recovery after discharge from ambulatory surgery

Conditions: Postoperative Nausea and Vomiting

Summary: the primary objective of this phase 2 randomized controlled trial is to determine whether the pre-operative administration of olanzapine (5 mg po) improves quality of recovery (assessed by the quality of recovery-40 (qor-40) survey) on postoperative day 1 in patients having ambulatory surgery with general anesthesia. the secondary objectives of this study are to determine whether there are differences in quality of recovery on postoperative day 2, presence of post-discharge nausea, presence of severe post-discharge nausea, recovery room length of stay and opioid consumption in patients who receive the study drug versus placebo.

up to 37% of patients undergoing ambulatory surgery experience postdischarge nausea and vomiting (pdnv), and pdnv represents a major barrier to improving a patient's quality of recovery. because olanzapine has been shown to be an effective drug for pdnv prevention, but carries the risk of sedation, this study seeks to identify if the administration of olanzapine is an intervention that improves a patient's overall quality of recovery. the study population includes women between 18 and 50 years-old who are undergoing ambulatory (outpatient) surgery at yale new haven hospital. this represents the population that is most susceptible to post-discharge nausea and vomiting (pdnv) and is therefore most likely to benefit from an intervention that reduces pdnv to impact overall quality of recovery.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * female aged 18-50 * scheduled to undergo ambulatory surgery under general anesthesia * access to smartphone device or computer with internet connection and has an email address exclusion criteria: * non-english speaking * unable to swallow pills * current use of anti-psychotic medications * history of allergy to olanzapine * pregnancy/lactation * current use of antihypertensive medication * diabetes mellitus * clinically significant cardiovascular disease defined as follows: 1. myocardial infarction or unstable angina within 6 months prior to the day of planned surgery. 2. history of serious ventricular arrhythmia (i.e.: ventricular tachycardia or ventricular fibrillation) or cardiac arrhythmias requiring anti-arrhythmic medications, except for atrial fibrillation that is well controlled on anti-arrhythmic medication. 3. new york heart association class ii or higher congestive heart failure. 4. postural hypotension or vasovagal syncope within 6 months of planned surgery. * hypotension on day of surgery, defined as a systolic blood pressure \< 90mmhg * seizure disorder * clinically active prolactinoma * hepatic disease * narrow angle glaucoma * parkinson's disease * lewy body dementia

Keywords: olanzapine placebo-controlled nausea vomiting ambulatory surgery procedures antiemetic general anesthesia
role of b2 adrenergic receptors in labor pain

Conditions: Pain; Pain Threshold; Labour Pain

Summary: the study aims to understand why labor is more painful for some women compared to others. the study will study whether a woman's baseline pain sensitivity, beta2 adrenergic receptor genotype is related to her pain in labor for the birth of a first child.

other than parity, and infant size, the etiology of the great variability in labor pain us unknown. previous studies have demonstrated that baseline pain sensitivity is related to postoperative pain and narcotic requirement. we hypothesize that baseline pain sensitivity is related to pain in labor. the study will determine baseline sensitivity to heat, cold and pressure as measurement of pain sensitivity. furthermore, b2 adrenergic genotype has recently been identified as a potential determinant of pain sensitivity. the investigators will determine whether b2 receptor haplotype is an independent predictor of pain experienced in labor.

Eligibility criteria:
inclusion criteria: * nulliparous women * third trimester of pregnancy on enrollment exclusion criteria: * chronic pain * pain medication utilization * large for gestational age baby * small for gestational age baby * systemic illness

Keywords: genetic pain obstetrical
zoledronic acid administration to metastatic breast cancer patients with non-symptomatic bone lesions

Conditions: Breast Cancer; Neoplasm Metastasis

Summary: this is an open-label, randomized, multicenter phase iii trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.

patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. one hundred twelve patients per treatment arm will be enrolled in the study. once bone-related symptoms appear, study participation is over. during the study, the following will be assessed: * quality of life, * performance status, * pain rating, * analgesic administration and * adverse events the principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.

Eligibility criteria:
inclusion criteria: * written informed consent. * age \>= 18 years old. * metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions. * non-symptomatic bone lesions, defined as pain absence, lack of bone complications (fracture, hypercalcemia, central nervous system (cns) compression), no need of analgesic chronic administration for bone disease. * a maximum of two chemotherapy lines for metastatic disease. * a maximum of two hormone therapy lines for metastatic disease. * normal, minimally altered renal function (serum creatinine \< 1.5 x upper normal limit (unl)). * normal serum calcium levels. * performance status 0,1 (world health organization (who)). * negative pregnancy test before study recruitment. exclusion criteria: * previous treatment with bisphosphonates or raloxifene in the 30 days prior to randomization. * metastasis in cns. * history of hypersensitivity to bisphosphonates. * pregnant or lactating women. * third chemotherapy line for metastatic disease. * third hormone therapy line for metastatic disease. * males.

Keywords: non-symptomatic bone metastases.
revive toric rwe study

Conditions: Astigmatism

Summary: this is a post-market observational clinical investigation. the objective of this observational study is to evaluate the visual performance and hcp satisfaction of revive samfilcon b custom toric contact lenses.


Eligibility criteria:
inclusion criteria: 1. be 18 years or older on the date the icf is signed 2. have the capacity to read, understand, and provide written voluntary informed consent 3. have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings 4. have no active ocular disease or allergic conjunctivitis 5. not be using any topical ocular medications 6. be willing and able to follow instructions 7. have signed a statement of informed consent 8. be an experienced soft contact lens wearer (have previously used soft contact lenses) 9. meet the indications per the instructions for use (ifu) and have a suitable prescription for treatment with the device exclusion criteria: 1. is participating in another research study 2. is considered by the investigator to not be a suitable candidate for participation 3. is not eligible for treatment with the study lens per the ifu (contraindicated) 4. has had previous ocular surgery 5. is taking/using ocular, systemic, or topical medications that, in the investigator's opinion, could potentially affect ocular physiology or lens/solution performance
a study to observe safety and blood concentrations of pf-06412562 during and following the oral administration of multiple doses of pf-06412562 in healthy adult volunteers

Conditions: Healthy

Summary: this study is designed to evaluate the safety and plasma concentrations of pf-06412562 in healthy volunteers following three times daily oral dosing of pf-06412562 for 14 days


Eligibility criteria:
inclusion criteria: * healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs); exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Keywords: multiple doses pharmacokinetics safety tolerability healthy volunteers steady state cognitive impairment associated with schizophrenia
neutrophil/lymphocyte (n/l) ratio and long term follow-up in st-elevation myocardial infarction

Conditions: ST Elevated Myocardial Infarction

Summary: although the pre-procedural neutrophil to lymphocyte ratio (n/l) has been associated with adverse outcomes among patients with coronary artery disease, its role during the acute phase of st-segment elevation myocardial infarction (stemi) has not been fully investigated. this study sought to investigate the association of the pre-procedural n/l ratio within-hospital and long-term outcomes among stemi patients undergoing primary percutaneous coronary intervention (pci).

inflammation plays a role in the initiation and progression of the atherosclerotic process. due to a growing recognition of its role, recent studies have focused on inflammatory markers and their association with outcomes in patients with st-segment elevation myocardial infarction (stemi). recently, our single center study demonstrated that preprocedural neutrophil/lymphocyte (n/l) ratio is an independent predictor of impaired coronary flow after primary percutaneous coronary intervention (pci) and of in-hospital major advanced cardiac events (mace) in patients with stemi.several previous studies also evaluated the role of n/l ratio in long-term outcomes among patients with stemi; however, they evaluated the association between long-term mortality and in-hospital n/l ratio, they were single-center studies and they evaluated a relatively small study population. in the present multicenter experience, the investigators aimed to investigate the association of the preprocedural n/l ratio with the in-hospital and long-term outcomes in patients with stemi undergoing primary pci.

Eligibility criteria:
inclusion criteria: st elevated myocardial infarction exclusion criteria: treatment with fibrinolytic drugs in the previous 24 hours active infection previously documented history of a systemic inflammatory process known malignancy end-stage liver disease renal failure

Keywords: n/l ratio, stemi, primary pci, long-term mortality
safety, tolerability, and pharmacokinetic of single dose of pitavastatin 4 mg in severe renal patients versus healthy adult volunteers

Conditions: Severe Renal Impairment

Summary: this is a phase 4, multicenter, open label, 1 period study. a total of 16 subjects are planned (8 subjects in group a and 8 subjects in group b): the 2 groups will be comparable in terms of age, gender, and body mass index (bmi); the ranges for comparison will be obtained from the pooled demographic data of the renally impaired subjects. the mean age of group b will be within 5 years of the mean age of group a, the mean bmi of group b will be within 18% of the mean bmi of group a, and the ratio of men to women in group b will be the same as in group a.


Eligibility criteria:
inclusion criteria: * subject is an adult male or female subject aged 18 years or older. females of childbearing potential must have a negative pregnancy test before beginning the study. * subject has no clinically significant medical conditions (other than renal impairment and associated diseases, such as hypertension, diabetes, and dyslipidemia, for subjects in group a) as determined by medical history, physical examination, 12-lead ecg, clinical laboratory results (hematology, serum chemistry, and urinalysis \[if able to pass urine\]), and serology results (hepatitis b surface antigen, hepatitis c virus antibody, and human immunodeficiency virus types 1 and 2 antibody). subjects with positive results for hepatitis c virus but who have normal liver enzymes will not be excluded. any subjects who have impaired hepatic function that will potentially affect drug metabolism should be excluded. * subject provides written informed consent before any study-specific evaluation is performed. * subject is able and willing to comply with the protocol and study procedures. exclusion criteria: * subject is on maintenance hemodialysis. * subject has a bmi of \>37 kg/m2.