Kornimate/medical-research-clean huggingface dataset:
code blue outcomes & process improvement through leadership optimization using teleintensivists-simulation

Conditions: Cardiac Arrest

Summary: this multicenter randomized trial will employ in-situ cardiac arrest simulations ("mock codes") to test whether using telemedicine technology to add an intensive care physician as the "copilot" for cardiac arrest resuscitation teams influences chest compression quality, resuscitation protocol adherence, team function, and provider experience.

only 15-30% of patients who suffer in-hospital cardiac arrest (ihca) survive to hospital discharge. factors associated with lower mortality and improved function include provision of high-quality, minimally-interrupted chest compressions and swift defibrillation of eligible arrhythmias. unfortunately, resuscitation teams provide suboptimal care to 25-40% of ihca victims. a dedicated ihca team "copilot" may improve resuscitation team performance by providing the team leader with parallel analysis, situational awareness augmentation, action checking, protocol verification, and error correction. critical care physician involvement via a telemedicine link could allow experienced specialists to fill the "copilot" role in a cost and resource-efficient manner, particularly in smaller hospitals with fewer available physicians. the current study will evaluate how consultation by an off-site intensive care physician via a telemedicine link influences local ihca teams' quality of care, team function and provider experience during simulated cardiac arrest events ("mock codes").

Eligibility criteria:
inclusion criteria (on-site cardiac arrest team): * are 18 years of age or older inclusion criteria (teleintensivist cardiac arrest team copilot): * are 18 years of age or older * are a board-certified or board-eligible critical care physician * provide clinical care through the intermountain healthcare telecritical care program exclusion criteria (both groups): * are under 18 years of age * are a member of the study research team

Keywords: code blue code team crisis team leadership cardiopulmonary resuscitation telemedicine simulation mock code in-hospital cardiac arrest
a study of efficacy of rituximab [mabthera/rituxan] in patients with rheumatoid arthritis using magnetic resonance imaging of the hand (resonar)

Conditions: Rheumatoid Arthritis

Summary: this randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab \[mabthera/rituxan\] in patients with severe active rheumatoid arthritis refractory to at least one anti-tnf treatment, using magnetic resonance imaging (mri) of the hand for efficacy measurement. patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg mabthera (group a) or placebo (group b). all patients will receive methotrexate 10-25mg weekly. patients in group a demonstrating clinical response at week 24 may receive further cycles of mabthera, patients in group b without clinical response will also be treated with active mabthera. anticipated time on study treatment is up to 2 years. target sample size is \<50 patients.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age * active rheumatoid arthritis (das28-crp\>3.2) * refractory to one or more anti-tnf * on stable treatment for ra for \>/=4 weeks * evidence of erosive disease and/or synovitis in wrist and/or knuckles exclusion criteria: * active systemic or local infection * previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia * signs of immunodeficiency, hiv infection or tuberculosis * contraindications to mri, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent
acute whole body vibration change the glycemic and lactate levels

Conditions: Diabetes

Summary: the type ii diabetes is characterized by high levels of blood glucose followed by excessive insulin release so that the target cells become less sensitive and develop insulin resistance, maintaining hyperglycemic levels. the whole body vibration session may improve the glucose metabolism in diabetic patients by reducing the peripheral blood sugar. ten healthy elderly women and eight diabetic elderly women were allocated into two groups, and have made an acute whole body session.


Eligibility criteria:
inclusion criteria: * elderly between 60 to 74 years, * sedentary according the international physical activity questionnaire (ipaq- short form) * for diabetic group, were considered who those medical diagnoses of type ii diabetes for at least 02 complete years, who had used only oral hypoglycemic agents of biguanides class (metformin extended release - xr) in dosage between 500 to 850 mg. * for healthy elderly group were considered elderly women without self-reported diseases exclusion criteria: * diabetic volunteers who have ingested the breakfast less than 02 hours or more than 03 hours and those who have taken metformin less than 02 hours before the intervention. for all volunteers, the complementary exclusion criteria were: * the current or past smoking or alcoholic habits; * the cardiovascular, liver or neuromuscular diseases; * subjects with prior labyrinthitis or embolic events; * who have had any surgery in last year; * volunteers with metallic prosthesis as pacemaker, pins or plates; * volunteers with advanced osteoporosis; * which had difficulties during the evaluation or acute protocol.
point of care test to diagnosed colorectal cancer and polyps in low middle income countries

Conditions: Colorectal Cancer

Summary: this is a-two phase study. phase 1 will adapt a 3-metabolite biosensor that identifies patients with colorectal cancer (crc) and precancerous polyps to nigerian patients. phase 2 will pilot test and evaluate the point-of-care (poc) biosensor device in nigeria.

in phase 1, urine will be collected from 450 nigerian patients (150 with crc, 150 with polyps, and 150 patients with no colon premalignant or malignant pathology. these samples will be used to refine a handheld biosensor. this handheld biosensor is intended to be a cost-effective poc diagnostic test highly sensitive for crc in nigerian patients. in phase 2, the biosensor device will be piloted in nigeria with 75 patients that are high-risk for crc.. after the pilot, poc test in real-time analysis on urine from 645 patients who are in one of three groups: 1.\> 40 years of age with rectal bleeding; 2.a family history of crc; 3. have a diagnosis of crc. all patients will receive a colonoscopy. beliefs and barriers related to urine testing for crc will be investigated. study will be completed within 5 years.

Eligibility criteria:
inclusion criteria: * patients \> 40 years of age with lgi bleeding or * patients who are high risk due to family history of crc o must be at most 10 years younger than when relative presented with crc (for example, a patient with a relative diagnosed at age 40 with crc will be eligible after age 30) or * patients with a diagnosis of stage i-iii crc who have no evidence of disease exclusion criteria: * patients who are unable to provide written informed consent; * previous diagnosis, treatment, or surgery for any cancer other than crc * age younger than 40 years with no family history of crc * any significant medical comorbidities * inability to provide a urine sample no fewer than 3 days before colonoscopy * inability to fully complete the patient satisfaction survey tool * diagnosis of or suspected inflammatory bowel disease.
ocriplasmin for vitreomacular traction/symptomatic vitreomacular adhesion

Conditions: Vitreomacular Traction; Vitreomacular Adhesion

Summary: the purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (jetrea™®) over a 6-month period.


Eligibility criteria:
inclusion criteria: * diagnosis of vmt/svma, with evidence of focal vmt visible on spectral domain - optical coherence tomography (sd-oct). * read, sign, and date an institutional review board/ethics committee-approved informed consent form. * willing and able to attend all study visits. * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * hypersensitivity to ocriplasmin or any of the jetrea™® excipients. * active or suspected intraocular or periocular infection in either eye. * participation in any interventional clinical trial within 30 days prior to baseline. * presence of epiretinal membrane (erm) over the macula at baseline in the study eye. * broad vmt/vma \> 1500 microns at baseline in the study eye. * history of vitrectomy in the study eye. * history of laser photocoagulation to the macula in the study eye. * any relevant concomitant ocular condition in the study eye that, in the opinion of the investigator, could be expected to worsen or require surgical intervention during the study period. * macular hole of \> 400 microns diameter in the study eye. * high myopia in the study eye. * pseudo-exfoliation, marfan's syndrome, phacodonesis, or any other finding in the study eye that, in the investigator's opinion, suggests lens/zonular instability. * aphakia in the study eye. * history of retinal detachment in the study eye. * recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy). * proliferative diabetic retinopathy or ischemic retinopathies in the study eye. * retinal vein occlusions in the study eye. * exudative age-related macular degeneration (amd) in the study eye. * vitreous hemorrhage in the study eye. * other protocol-specified exclusion criteria may apply.

Keywords: vmt svma vitrectomy ocriplasmin
an open-label study of naltrexone in adults with attention deficit hyperactivity disorder.

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating attention deficit hyperactivity disorder (adhd) in adults. medications that increase dopamine are often effective in treating adhd in adults. since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. we predict that naltrexone as a monotherapy will be effective for adhd symptoms in adults with adhd.


Eligibility criteria:
inclusion criteria * male and female outpatients 18-55 years of age. * diagnosis of adhd, by dsm-iv by clinical evaluation by an expert clinician. * subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least one month, and who have a disorder-specific cgi-severity score ≤ 3 (mildly ill) and who have a score on the hamilton-depression and hamilton-anxiety rating scales below 15 (mild range). exclusion criteria * any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency. * current (last 3 months) substance use disorders (alcohol or drugs), * medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, history of renal or hepatic impairment, or a condition that will or may require treatment with opioid analgesics. * clinically significant abnormal baseline laboratory lft's, which is defined as lft's greater than the uln. * mental retardation (iq \< 80). * organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness. * pregnant or nursing females. * subjects with current adequate treatment for adhd. * current treatment with medication for adhd. * any other concomitant medication with primarily central nervous system activity other than specified in the protocol (a stable and effective treatment regimen of an ssri or benzodiazepine is permitted per clinical review.) * a clinical global impression (cgi) of 7 (among the most extremely ill patients) at the screening visit is exclusionary, and any subject who presents a cgi-s of 7 at any point during the study will be removed from participation. * subjects presenting with a cgi-severity score of 6 (severely ill) at two consecutive visits after week 2 will be dropped from the study (i.e. a subject with a cgi of 6 at his/her week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit). subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary. * non-english speaking subjects

Keywords: adhd naltrexone adults
long-term extension study of inhaled nitric oxide (ino) for pah

Conditions: Pulmonary Arterial Hypertension

Summary: an open-label long-term safety study of inhaled nitric oxide (ino) for pulmonary arterial hypertension (pah)

an open-label, long-term study to evaluate the safety of inhaled nitric oxide (ino) in subjects with pulmonary arterial hypertension (pah) who participated in ik-7001-pah-201 and pulse-pah-004 to provide these patients with continued access to chronic ino until the time of approval or development of ino in pah is discontinued.

Eligibility criteria:
inclusion criteria: * signed informed consent form prior to the initiation of any study mandated procedures or assessments. * pah subjects who have completed all eos assessments in ik-7001-pah-201 and pulse-pah-004 and have continued drug/device usage. * subjects are willing and considered in the judgement of the investigator able to use the inopulse device continuously for up to 24 hours per day. * all female subjects must be willing to continue to take adequate precaution to avoid pregnancy. * subjects in need for continued treatment with ino in the opinion of the treating physician and agreement from sponsor. exclusion criteria: * subjects who require treatment with riociguat * subjects who early discontinued drug/device usage due to withdrawal of consent or an ae requiring termination from treatment in ik-7001-pah-201

Keywords: pah pulmonary arterial hypertension inhaled nitric oxide ino
anterior cruciate ligament reconstruction: residual rotational laxity for single versus double bundle techniques

Conditions: Anterior Cruciate Ligament Injury

Summary: the main objective of this study is to compare, using mri measures with a specialized splint, the persistent rotatory laxity after anterior cruciate ligament reconstruction using single bundle and double bundle surgical techniques, between the seventh and eighth months after surgery, and for different degrees of knee flexion (0 °, 20 °, 40 °, 60 °).


Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 24 months of follow-up * the patient requires reconstruction of the anterior cruciate ligament due to rupture confirmed by mri exclusion criteria: * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * the patient is breastfeeding * the patient require a single bundle, "kj-type" surgical technique * contra-indication for mri scans

Keywords: residual rotational laxity
etude rétrospective monocentrique matrix

Conditions: Melanoma

Summary: "monocentric retrospective study.analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy. objective: to assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus. monocentric retrospective study.analysis of a case series of patients who underwent nail resection with dermal matrix and skin graft reconstruction in the setting of nail bed malignancy. objective: to assess patients' quality of life and satisfaction with the function and aesthetics of dermal matrix and skin graft reconstruction of the nail apparatus. "


Eligibility criteria:
inclusion criteria: - adult patients who have undergone complete nail removal for malignancy - reconstructed with integra dermal matrix and total skin graft. exclusion criteria: -minor patients -patients who have undergone complete removal of the nail apparatus for malignancy but have been reconstructed in another way (flap, isolated skin graft)
trial evaluating the safety of a lactate releasing vaginal ring for the prophylaxis of bacterial vaginosis

Conditions: Vaginosis, Bacterial

Summary: in this first-in-human volunteer phase i clinical trial, a vaginal ring that slowly releases lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy volunteering women and left in place for 7 days. the primary objective of this phase i study is to assess the safety and the tolerability of this new intravaginal delivery system. the eventual goal of this and related studies is to develop a vaginal ring that reduces recurrences in women suffering from bacterial vaginosis, which is the commonest form of vaginal infection.


Eligibility criteria:
inclusion criteria: * good general physical and mental health * presence of normal (lactobacilli-dominated) vaginal microbiota * prepared to take oral contraception during the study exclusion criteria: * pregnancy * lactation * systemic disease * menopause * recent use of antibiotics (\<1 week before entering the study) * recent use of intravaginal products or devices (\<1 week before enrolment) * presence of vaginal infection
improving access to eye care in glaucoma patients

Conditions: Glaucoma

Summary: 1. to design and develop a prospective, randomized pilot study utilizing information from electronic medical records to address follow-up adherence and reduce the gap between recommended and actual follow-up adherence in patients with glaucoma. 2. to evaluate the impact of a telephone-based intervention on follow-up adherence in patients with glaucoma using a randomly assigned comparison with usual care.

the wills eye health system (wehs) proposes to conduct a pilot study to evaluate the feasibility and effectiveness of a telephone-based intervention to improve rates of follow-up exams in patients with glaucoma. the prospective, randomized, controlled trial entitled "improving access to eye care in patients with glaucoma" will utilize cohort data from 2013 electronic medical record information to reduce the gap between recommended and actual follow-up utilization of eye care services in glaucoma patients. patients with glaucoma will be recruited from the wills eye glaucoma clinic who were seen between 3/1/13 and 10/31/13. a recall list will be generated for patients who have scheduled follow-up appointments from 9/1/13 to 11/30/13. these patients will be randomly assigned to the "usual care" group or "intervention" group. the primary outcome will be successful attendance at a follow-up appointment within an appropriate time frame. this intervention is based on a cdc funded project at wills to improve access to eye care in patients with diabetes. thus, this pilot study will test the efficacy of a telephone-based intervention to improve follow-up adherence in patients with glaucoma by improving access to eye care.

Eligibility criteria:
inclusion criteria: * attended wills eye glaucoma clinic from 9/1/12 and 10/31/13 exclusion criteria: * any medical condition that would preclude the subject from providing reliable and valid data. * recommended to f/u in less than 1 month time period.

Keywords: glaucoma eye care community outreach
gw873140 in combination with combivir in hiv infected subjects

Conditions: Infection, Human Immunodeficiency Virus I; HIV Infection

Summary: this study is a 96-week study designed to evaluate the safety and efficacy of gw873140 in combination with combivir in hiv infected, untreated subjects.

a phase iib, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of gw873140 in combination with combivir (lamivudine and zidovudine) upon selected immunological and virological markers of hiv-1 infection in antiretroviral therapy naive adults

Eligibility criteria:
inclusion criteria: * hiv infected subjects. * females must be of either non-childbearing age, or have a negative pregnancy test. * all subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study. * screening lab result of plasma hiv-1 rna greater than or equal to 10,000 copies/ml and cd4 cell count greater than or equal to 100 cells/mm3. * have cc chemokine receptor5-tropic (r5-tropic) virus based on viral tropism test at screening visit. * have no drug resistance mutations in hiv-1 reverse transcriptase based on resistance test at screening visit. * be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (pi) or a nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (nrti/ ntrti), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (nnrti). * prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed. * be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions. * signed and dated written informed consent prior to study entry. exclusion criteria: * detection of any cxc receptor4-tropic (x4-tropic) virus, based on viral tropism test at screening. * any drug resistance mutations in hiv-1 reverse transcriptase based on resistance test at screening visit. * active class c aids-defining illness. * laboratory abnormalities at screen. * significant blood loss prior to study start. * pregnant or breastfeeding women. * additional qualifying criteria to be determined by the physician.

Keywords: hiv infections therapy naive
internet-based pre-fitting counseling of persons with hearing impairment

Conditions: Disability Evaluation

Summary: the purpose of this study is to determine whether the use of 'patient journey' model in internet-based counseling of a person with hearing impairment is a feasible approach in management of emotional and social consequences, anxiety and depression, readiness to change and acceptance of hearing loss.


Eligibility criteria:
inclusion criteria: * ages over 18 years old * have symptoms of hearing difficulty * access to internet exclusion criteria: * hhq results too low (i.e., below 20), * participants using hearing aids * those with additional disabilities (e.g., visual impairment, learning disability, dementia, and so on) which may affect individuals' ability to participate in an internet-based program

Keywords: disability evaluation