Kornimate/medical-research-clean huggingface dataset:
fascia iliaca compartment block for analgesia after total hip arthroplasty

Conditions: Pain Disorder; Sensory Deficit

Summary: introduction fascia iliaca compartment block (ficb) is commonly used to treat pain in patients after total hip arthroplasty (tha) despite the lack of rcts to evaluate the efficacy of ficb for this indication. therefore the objective of this study was to assess the analgesic benefit of ficb for post-operative pain management in tha. methods after irb approval and informed consent, patients having tha at our center in the period 2010-2011 were recruited. eligible patients were adults, asa physical status i-iii, and bmi \ 3 on the nrs-11 despite ivpca were randomized by the method of sealed envelopes to receive us guided injections of 30ml 0.5% ropivacaine (ficb) or 30ml 0.9% nacl (sham block, sb) beneath the fascia iliaca. the primary outcome variable was opioid analgesic consumption during the first 24 h postoperatively. secondary outcome measures were pain intensity (nrs-11) and extent of sensory blockade.

introduction fascia iliaca compartment block (ficb) is commonly used to treat pain in patients after total hip arthroplasty (tha) despite the lack of rcts to evaluate the efficacy of ficb for this indication. therefore the objective of this randomized, prospective trial was to assess the analgesic benefit of ficb for post-operative pain management in tha. our hypothesis was that ficb would confer an analgesic benefit for patients after tha. methods after irb approval and informed consent, patients having tha at our center in the period 2010-2011 were recruited in the morning of their surgery. eligible patients were adults, asa physical status i-iii, and bmi \ 3 on the nrs-11 despite ivpca were randomized by the method of sealed envelopes to receive us guided injections of 30ml 0.5% ropivacaine (ficb) or 30ml 0.9% nacl (sham block, sb) beneath the fascia iliaca. the primary outcome variable was opioid analgesic consumption during the first 24 h postoperatively. secondary outcome measures were pain intensity (nrs-11) and extent of sensory blockade.

Eligibility criteria:
inclusion criteria: * adults * asa physical status i-iii * bmi\<30 * no contraindications to study procedures exclusion criteria: * pediatric patients * asa physical status iv * bmi\>30 * contraindications to study procedures * hypersensitivity to local anesthetics

Keywords: fascia iliaca compartment block, pain, sensorial blockade
placebo controlled evaluation of sedation and physiological response to intranasal dexmedetomidine in severe copd

Conditions: COPD

Summary: a variety of medications have been used to treat the anxiety, discomfort, and fear associated with continuous and sudden episodic breathlessness in patients with advanced respiratory disease. opioids and benzodiazepines, used alone or in combination, are commonly prescribed for this distressing symptom. clinicians are concerned about the adverse effects of opioids, especially respiratory depression, so they frequently prescribe benzodiazepines. recent studies have shown that benzodiazepine use is associated with adverse respiratory outcomes in older adults with chronic obstructive pulmonary disease (copd). dexmedetomidine may be an alternative to current drug therapies for breathlessness. dexmedetomidine produces a dose dependent sedation, anxiolysis, and analgesia without respiratory depression or cognitive dysfunction. the drug can be administered intranasally (in-dex) to induce light to moderate sedation of several hours duration. the objective of the research is to assess the dose dependent safety and efficacy of intranasal dexmedetomidine compared to intranasal saline (placebo) in clinically stable patients with severe copd. this will be accomplished in a staffed acute care setting with routine vital signs monitoring and continuous pulse oximetry. patients will be assessed objectively and subjectively for their level of sedation by validated sedation scales. the study is an extension of a similarly designed pilot study which did not include a placebo comparison. results of the study will be helpful to design additional trials with intranasal dexmedetomidine in acutely symptomatic copd patients, exertional dyspnea and exercise performance, and dyspnea treatment comparisons.


Eligibility criteria:
inclusion criteria: * severe copd (fev1 \< 50% predicted) * age 45-70 * american society of anesthesiologists (asa) class 3 * body mass index \< 35 kg/meter squared * no prior history of adverse reactions to alpha 2 agonists (dexmedetomidine, clonidine) exclusion criteria: * known adverse reaction, allergy or hypersensitivity, to alpha 2 agonists * not nothing by mouth (npo) * asa class \>3 * home oxygen therapy \>2lpm by nasal cannula continuous use * any evidence of nasal mucosal inflammation, irritation, bleeding or ulceration * pregnancy, or possibility of pregnancy * coronary heart disease with stable or unstable angina * baseline heart rate \<55 beats per minute * bradyarrhythmia, heart block, presence of pacemaker * congestive heart failure or known cardiomyopathy (ejection fraction \<40% by echo, muga, or myocardial perfusion imaging) * cor pulmonale * liver disease (hepatic transaminases \> 2x upper limit of normal, cirrhosis, end stage liver disease) * diagnosis of moderate to severe obstructive sleep apnea * currently enrolled in any other research study involving drugs or devices

Keywords: sedation dexmedetomidine
mechanical versus alcohol epithelial debridement during hotorefractive keratectomy (prk)

Conditions: Refractive Error; Myopia

Summary: in this prospective randomized clinical trial, confocal microscopy was used to evaluate the effect of mechanical versus alcohol-assisted epithelial debridement during photorefractive keratectomy (prk)on corneal cellular elements. sixty-six eyes of 33 subjects with a spherical equivalent less than -4.00 d who completed all follow-up visits were evaluated.


Eligibility criteria:
inclusion criteria: * spherical equivalent ≤ -4.0 d * cylinder ≤ 1.50 d exclusion criteria: * history of ocular trauma or surgery * any corneal and ocular pathologies * central corneal thickness \< 500 µm * scotopic pupil diameter \> 6.0 mm * any abnormalities in corneal plain or elevation topographies favoring keratoconus or other ectatic disorders * the presence of systemic disorders such as collagen vascular diseases

Keywords: photorefractive keratectomy prk alcohol-assisted debridement mechanical debridement confocal scan confocal microscopy
gefitinib in treating patients with stage i, stage ii, or stage iii esophageal cancer that can be removed by surgery

Conditions: Esophageal Cancer

Summary: rationale: gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. giving gefitinib before surgery may shrink the tumor so that it can be removed. purpose: this phase ii trial is studying how well gefitinib works in treating patients with stage i, stage ii, or stage iii esophageal cancer that can be removed by surgery.

objectives: primary * determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage i-iii esophageal cancer. secondary * determine the epidermal growth factor-receptor expression in tissue samples obtained at diagnosis and surgery from patients treated with this drug. outline: this is an open-label study. patients receive oral gefitinib once daily beginning between days -21 and -14 and continuing until day -1. patients undergo tumor resection on day 0. after completion of study treatment, patients are followed periodically for 6 months. projected accrual: a total of 30 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus * resectable, localized disease with or without metastases in local lymph nodes (t1, t2, or t3; any n; m0) * stage i-iii disease * no known distant metastases * no cervical-esophageal tumors (upper border \< 18 cm from the incisor teeth) * no supraclavicular metastases patient characteristics: performance status * ecog 0-2 life expectancy * not specified hematopoietic * adequate bone marrow function hepatic * adequate hepatic function * no unstable or uncompensated hepatic disease renal * creatinine ≤ grade 2 by common toxicity criteria * adequate renal function * no unstable or uncompensated renal disease cardiovascular * no unstable or uncompensated cardiac disease pulmonary * no clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes * no unstable or uncompensated respiratory disease other * not pregnant or nursing * fertile patients must use effective contraception * no known hypersensitivity to gefitinib or any of the excipients * no other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix * no evidence of severe or uncontrolled systemic disease * no other significant clinical disorder or laboratory finding that would preclude study participation prior concurrent therapy: endocrine therapy * concurrent stable-dose steroids allowed surgery * recovered from any prior oncologic or other major surgery other * more than 30 days since prior nonapproved or investigational drug * no prior therapy for this or any other malignancy * no concurrent phenytoin, carbamazepine, barbiturates, rifampin, or hypericum perforatum (st. john's wort)

Keywords: stage i esophageal cancer stage ii esophageal cancer stage iii esophageal cancer adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus
study to evaluate the impact of the use of alternative and complementary therapies on therapeutic adherence in patients treated with tamoxifen for early stage breast cancer

Conditions: Breast Cancer

Summary: this is a pilot, prospective, interventional, monocentric study designed to evaluate, in a real-life situation, adherence to tamoxifen treatment as a function of the taking of alternative and complementary therapies in patients with localized hormone-dependent breast cancer. 200 patients will be included in the study. each patient will be followed for one day.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years at entry into the study. 2. patient treated for hormone-dependent localized breast cancer requiring adjuvant hormonal therapy (ht) with tamoxifen. 3. patients treated with tamoxifen for a maximum of 1 to 3 years. 4. patient affiliated with a social security system in france. 5. patients who signed informed consent prior to inclusion in the study and prior to any specific study procedures. exclusion criteria: 1. pregnant or breastfeeding women. 2. any psychological, family, geographical or sociological condition that does not allow the medical follow-up and/or the procedures foreseen in the study protocol to be respected. 3. patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Keywords: breast cancer tamoxifen alternative and complementary therapies treatment adherence turmeric
proteomics analysis for recognition of acute cellular rejection after lung transplantation

Conditions: Rejection; Lung Transplantation

Summary: in patients with acute rejection after lung transplantation the peptide profile in broncho-alveolar lavage (bal) and urine should be compared in order to identify a paradigm that allows an non-invasive rejection therapy.

goal of the study is the establishment of biomarkers for early diagnosis of acute rejection, followed by a late validation of the paradigm with prospectively collected samples, which will be examined blinded.

Eligibility criteria:
inclusion criteria: * patients with stable graft function * patients with acute rejection exclusion criteria: * acute infection * bos

Keywords: proteomics lung transplantation
resiliency program for medical interpreters

Conditions: Psychological Stress

Summary: to develop and test a 4-session program to teach resiliency skills to medical interpreters.

this study aims to improve quality of cancer care for lep patients through improving medical interpreters' ability to cope with difficult encounters. we propose to (1) identify the needs of medical interpreters working with cancer patients, and (2) develop and test a psychoeducational resiliency program at 3 df/hcc cancer centers: mgh, dfci, and bwh) intended to enhance interpreters' skills to effectively manage stressful encounters and to cope with the personal effects of encounters.

Eligibility criteria:
inclusion criteria: 1. interpreter employed at one of the 3 study hospitals 2. \>=20 hours/week exclusion criteria: 1) interpreter working \<20 hours per week

Keywords: resiliency burnout stress
nutrition education program in spinal cord injury (sci)

Conditions: Spinal Cord Injuries

Summary: the purpose of this research is to assess the effectiveness of a nutrition education program in increasing nutrition knowledge and improving health-related biomarkers in individuals with spinal cord injury (sci).


Eligibility criteria:
inclusion criteria: - adults with sci with complete and incomplete (american spinal injury association impairment scale score a-d) paraplegia or ventilator-independent tetraplegia. exclusion criteria: * participants who do not meet inclusion criteria. * adults unable to consent. * individuals who are not yet adults (infants, children, teenagers) * pregnant women (self-report) * prisoners

Keywords: metabolic dysfunction nutrition education
effect of enhanced external counterpulsation on lower urinary tract symptoms

Conditions: Lower Urinary Tract Symptoms

Summary: the purpose of this study is to access the effects of enhanced external counterpulsation treatment on lower urinary tract symptoms in patients with benign prostatic hyperplasia.

patients with benign prostatic hyperplasia and will be randomized into two groups: eecp intervention or not. lower urinary tract symptoms, hemodynamic parameters, vascular endothelial function will be measured and compared

Eligibility criteria:
inclusion criteria: 1. men over 18 years old; 2. provide signed informed consent; 3. existence of lower urinary tract symptoms 4. agree not to use any lower urinary tract symptoms treatment at least one month; 5. suitable for receiving eecp treatment exclusion criteria: 1. history of long drug abuse; 2. pelvic, spine, brain trauma or surgery; 3. endocrine, liver, lung, kidney disease, malignancies, hematological disorders; 4. severe infection without effective control； 5. lower limbs deep vein thrombosis； 6. large area of ulcerative rash； 7. unsuitable for receiving eecp treatment

Keywords: lower urinary tract symptoms benign prostatic hyperplasia urinary retention vascular endothelium counterpulsation, external
protective effects of epi-743 on noise-induced hearing loss

Conditions: Noise-induced Hearing Loss

Summary: if effective, administration of epi-743 should have protective effects against temporary noise-induced hearing loss.


Eligibility criteria:
inclusion criteria: * healthy adults ages 18-30 * abstention from use of idebenone, coq10, vitamin e and foods or beverages at least 30 days prior to treatment initiation * non-smokers * abstention from alcohol from day 0 and throughout the duration of study * normal audiology exam * subject must be able to swallow size 0 capsules exclusion criteria: * allergy to epi-743 or sesame oil or nuts * any medical disordere that would prevent subject participation * any prescription meds other than for contraception or seasonal allergies * any significant patient medical history (cancer, cardiovascular, pulmonary, cognitive, adhd, hx. of migraines, neurological, kidney) * fat malabsorption syndromes * anticoagulation thereapy within 30 days of enrollment

Keywords: hearing noise oxidative stress
feasibility and effectiveness of a specialized brief intervention for hazardous drinkers in an emergency department.

Conditions: Alcohol Drinking

Summary: alcohol use and its consequences represent an important public health problem. as well as alcohol dependence, hazardous drinking also contributes to a high burden in terms of morbidity and mortality. to improve these patients' prognosis and decrease associated social and health care costs, it is necessary to increase early detection, intervention and treatment for these problems. for these reasons, sbirt programmes (screening brief intervention and referral to treatment) have been developed, evaluated and shown to be effective, particularly in primary care and general practice. nevertheless, effectiveness of sbirt in emergency departments (ed) has not been clearly established. the investigators aimed to evaluate the feasibility and efficacy of an sbirt programme in the ed of a tertiary hospital.

the investigators conducted a randomized controlled trial to study the feasibility and efficacy of an sbirt programme for hazardous drinkers presenting in an ed. all patients older than 18 years old attending the emergency department were potentially eligible. cognitively impaired or medically unstable patients were excluded. patients seeking treatment for alcohol use were also excluded. patients were randomized to two groups, with the control group receiving two leaflets - one regarding alcohol use, and the other giving information about the study protocol. the intervention group received the same leaflets as well as a brief motivational intervention on alcohol use; and, where appropriate, a referral to specialised treatment. the primary outcomes were the proportion of hazardous drinkers measured by audit-c scale and the proportion of patients attending specialised treatment at 1.5 and 4.5 months and 1 year.

Eligibility criteria:
inclusion criteria: * all patients aged 18 or older attending to the emergency department were potentially eligible patients * patients with an audit-c score higher than 6 points for men and 5 for woman were invited to participate exclusion criteria: * cognitive impairment * medically unstable * patients explicitly demanding alcohol treatment
cp-690-550 ointment for chronic plaque psoriasis

Conditions: Psoriasis

Summary: the study is being conducted to see whether cp-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.


Eligibility criteria:
inclusion criteria: * mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months; * a target plaque of at least 9 sq. cm. exclusion criteria: * demonstrates "rebound" or "flare" of chronic plaque psoriasis; * non plaque form of psoriasis; * currently have or history of psoriatic arthritis; * current drug induced psoriasis; * currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months; * currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months

Keywords: multi site randomized placebo controlled double blind parallel group chronic plaque psoriasis topical treatment skin diseases papulosquamous
donate-pilot study on icu management of deceased organ donors

Conditions: Deceased Organ Donors; Critical Care

Summary: the donate-pilot is a prospective observational cohort study in organ donation (od) that observes the icu management of consented deceased organ donors at 4 high volume centres over a period of 12 months each. the pilot study will be followed by a 1-year prospective national observational study a 15-20 icus across canada.

this prospective observational cohort pilot study enrols consented organ donors admitted to 4 high volume centres over a period of 12 months. various clinical data on deceased donors are collected prospectively from the time of consent for organ donation up to and including the day of organ recovery. the main objectives of the donate-pilot reflect the objectives of the national study which correspond to the steps in developing a platform for future clinical trials. 1. form research teams at participating icus that will include an icu physician-researcher, a local organ donation champion, icu research coordinators and (in a limited role) a local coordinator from the provincial organ donation organization (odo); 2. observe, record, and describe icu practices in deceased donor care (e.g., donor resuscitation, organ suitability assessments, death declaration) which are likely to vary by site, region and province and will be very important to inform clinical care protocols for future rcts. 3. engage and work with odos from each province to foster data sharing and develop procedures to enhance efficiency in future rcts. 4. investigate the comparative effectiveness of various icu interventions in deceased donor care (e.g. the potential for hormonal therapies to improve transplant rates, the potential of heparin therapy to improve peri-operative graft function); 5. produce specific knowledge translation tools that will serve in the future as both clinical tools to enhance icu care and research tools to facilitate future rcts. as part of the donate-pilot we also aim to assess feasibility. specifically the objectives are to: 1. refine data collection procedures for deceased donors in icu; 2. estimate time requirements for data collection; 3. develop efficient links to post-transplantation data and; 4. share data as it accrues with clinicians.

Eligibility criteria:
inclusion criteria: * admitted to a critical care area (icu, picu, ccu, er) * consented deceased organ donors (dnd and dcd) exclusion criteria: * neonate \<36 weeks gestation
evaluating ventricular arrhythmia in subjects with implantable cardioverter defibrillator or cardiac resynchronization therapy-defibrillator

Conditions: Ventricular Arrhythmia

Summary: the primary objective of this study is to evaluate the effect of eleclazine (gs-6615) compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (icd) interventions (antitachycardia pacing \[atp\] or shock) in adults with icd or cardiac resynchronization therapy-defibrillator (crt-d).


Eligibility criteria:
key inclusion criteria: * have an icd or crt-d implanted for primary or secondary prevention and at least one icd intervention for ventricular tachycardia/ventricular fibrillation (vt/vf) \[shock or atp\] within 60 days prior to screening or a documented vt/vf episode (prior to implantation) within 60 days prior to screening * use of highly effective contraception methods if female of childbearing potential or sexually active male * must be hemodynamically stable key exclusion criteria: * new york heart association (nyha) class iv heart failure * myocardial infarction, unstable angina, coronary artery bypass graft (cabg) surgery or percutaneous coronary intervention (pci) within 4 weeks prior to screening or during the screening period before randomization * hemodynamically significant primary obstructive valvular disease * history of congenital heart disease * inherited arrhythmia such as brugada syndrome. individuals with long qt syndrome type 3 (lqt-3) or hypertrophic cardiomyopathy (hcm) may be considered. * individuals who are being considered for cardiac transplantation and are on a cardiac transplant list * history of seizures or epilepsy * cardiac ablation within 3 months prior to screening or planned cardiac ablation during the study * severe renal impairment * abnormal liver function tests * currently taking class i and class iii antiarrhythmic drugs; such medications should be discontinued 5 half-lives (or 28 days for chronic use of amiodarone) prior to randomization * currently taking drugs or products that are strong inhibitors or inducers of cyp3a; such medications should be discontinued 5 half-lives prior to randomization * currently taking ranolazine; ranolazine should be discontinued at least 7 days prior to randomization * females who are pregnant or are breastfeeding * individuals with a subcutaneous icd * body mass index (bmi) ≥ 36 kg/m\^2 note: other protocol defined inclusion/exclusion criteria may apply

Keywords: vt vf ventricular tachycardia ventricular fibrillation shock atp