Kornimate/medical-research-clean huggingface dataset:
does body positioning affect the yield of hyperventilation in routine pediatric electroencephalography - eeg studies?

Conditions: Epilepsy, Absence

Summary: children referred for routine eeg studies for suspected absence seizures will be asked, upon caregiver's informed consent, to perform 3 minutes of hyperventilation both in the supine position and while sitting up. we aim to demonstrate that hyperventilation is more effective in eliciting absence seizures in a sitting position than while lying down.

hyperventilation is a very effective means of eliciting absence seizures in children with absence epilepsy. worldwide eeg protocols for routine eeg recording include 3 minutes of hyperventilation. the whole eeg recording, including hyperventilation, is performed with the child lying down on a bed/coach. our clinical experience suggests that the body position may affect the yield of hyperventilation in provoking the absence event. that is, hyperventilation may be more effective when the child is sitting up, therefore, children referred for a routine eeg for suspected absence seizures will add 3 minutes of hyperventilation on a sitting position to the routine 3 minutes of supine hyperventilation. at least 5 minutes of rest will be allotted between both procedures. patients' caregivers will sign an informed consent form. patients will randomly be divided into 2 groups: one group will first perform supine hyperventilation followed by sitting hyperventilation; the second group will perform hyperventilation in the opposite order, ie, first sitting up and then in supine position.

Eligibility criteria:
inclusion criteria: * children referred for a routine eeg for suspected absence epilepsy exclusion criteria: * patients unable to perform hyperventilation * children previously diagnosed with absence epilepsy * children receiving antiepileptic drugs
comparative efficacy study of 10 mg dequalinium chloride (fluomizin) in the treatment of vulvovaginal candidiasis

Conditions: Vulvovaginal Candidiasis

Summary: a clinical study to compare the clinical efficacy of vaginal tablets containing 10mg dequalinium chloride (fluomizin) with the clinical efficacy of 100mg clotrimazole in patients suffering from vulvovaginal candidiasis, to assess safety of the two medications during the treatment, and to evaluate women's satisfaction with the two treatments.


Eligibility criteria:
inclusion criteria: * clinical signs and symptoms of vulvovaginal candididiasis as total severity score, total severity score of at least 4 (0-15: vaginal itching (0-3), vaginal burning or soreness (0-3), abnormal vaginal discharge (0-3),vulvo/vaginal erythema or edema(0-3), vulvar excoriation or fissure formation (0-3). * direct microscopy (wet smear) positive for yeast forms (hyphae/pseudohyphae) or budding yeasts. * normal vaginal ph (higher than 4.5) at baseline. * women aged 18 - 45 years old. * women can comply with all clinical trial instructions, and can return to all follow-up visits. * signed written informed consent to participate in this study. exclusion criteria: * recurrent vulvovaginal candidiasis(4 episodes of vvc in the last 12 months). * women with other cause of vaginal infections, e.g. bacterial vaginosis, aerobic vaginitis, trichomoniasis, and mixed infections * women using oral or vaginal antifungals within 2 weeks prior to enrolment and during the study. * women using any intra-vaginal products, also vaginal douches containing soaps and other anionic, surface-active substances, within 2 weeks prior to enrolment and during the study. * women using any antibiotic or anti-infective within 2 weeks prior to enrolment. * cervicitis, abnormal pap smear in the last 6 month. * severe systemic diseases (hiv infection, diabetes mellitus, cancer, tuberculosis, autoimmune diseases, severe psychiatric conditions, etc.). * women with confirmed neisseria gonorrhoea or chlamydia trachomatis. * women having menstruation bleeding at enrolment. * known or suspected hypersensitivity to one of the study medications, inclusive their excipients. * participation of patient in another investigational drug study concomitantly or within 30 days prior to entry in the study. * patient is relative of, or staff directly reporting to, the investigator.

Keywords: vulvovaginal candidiasis vulvovaginal candidosis mycotic vaginal infection dequalinium chloride fluomizin clotrimazole canesten
oral hypoglycemic therapy for monogenic variant carriers of the joslin medalist study

Conditions: Type 1 Diabetes; Monogenic Diabetes

Summary: the purpose of this study is to evaluate the efficacy of adding oral hypoglycemic agents (oha) to existing insulin treatment in monogenic variant carriers of the joslin 50-year medalist study ("medalists"), who are characterized by ≥50 years of insulin-dependent diabetes. our primary objective is to evaluate whether the presence of human leukocyte antigen (hla) high-risk alleles for diabetes (dr3 and/or dr4) can affect the effectiveness of oha in these subjects.


Eligibility criteria:
inclusion criteria: * existing participants in the joslin 50-year medalist study * residing in the united states * capable of giving informed consent * known detectable c-peptide \>0.05 ng/ml exclusion criteria: * known diagnosis of cancer or active inflammatory disease such as rheumatoid arthritis, lupus, and inflammatory bowel disease * recent history of myocardial infarction, angioplasty, bypass surgery, heart failure, angina, stroke, or uncontrolled hypertension\>160/100 during the past 3 months * known diagnosis of cognitive dysfunction, dementia or alzheimer's disease * pre-existing liver disease or liver function tests (ast or alt)\>3x the upper limit of normal * pre-existing kidney disease (chronic kidney disease stage iv and below, or estimated glomerular filtration rate\<45 ml/min/1.73 m2) * active use of immunosuppressants * recipients of prior islet cell or pancreas transplantation * inability to travel due to frailty or health reasons * donated blood within the previous two (2) months
ibrance real world insights

Conditions: Malignant Neoplasm of Breast

Summary: to describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.


Eligibility criteria:
physician inclusion criteria * oncologist or gynecologist * responsible for treating a minimum of ≥2-6 (depending on country) abc/mbc patients who meet the eligibility criteria. * agrees to participate in the study and complete the ecrfs within the data collection period. patient inclusion criteria * female * ≥18 years old. * hr+/her2- breast cancer diagnosis with confirmed metastatic or advanced disease. * received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s). * no prior or current enrolment in an interventional clinical trial for abc/mbc. * minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review). * minimum of three months of follow up data since palbociclib initiation (german interim medical record review only). * inoperable or recurrent breast cancer (japan only) exclusion criteria: physician exclusion criteria * qualified less than 2 years ago or more than 35 years ago * participated in observational research for abc/mbc in the last 3 months * have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).

Keywords: metastatic breast cancer advanced breast cancer hr+/ her2-
prone position in acute bronchiolitis

Conditions: Acute Viral Bronchiolitis

Summary: acute viral bronchiolitis is the leading cause of community-acquired acute respiratory failure in developed countries (20 000 to 30 000 hospitalizations each year in france). between 5% and 22% of these children are hospitalized in a critical care unit to benefit from a respiratory support. non-invasive ventilation, in particular the nasal continuous positive airway pressure (ncpap), reduces the work of breathing in children with bronchiolitis and is associated with decreased morbidity and hospitalization costs compared with invasive ventilation. nowadays, this technique is considered as the gold standard in the pediatric intensive care units (picu) in france. high flow nasal cannula (hfnc) has been proposed as an alternative to the ncpap because of its better tolerance and simplicity of implementation. however, the proportion of failure remains high (35 to 50%), providing only a partial response to the care of these children, especially prior to the picu. in a physiological study (nct02602678, article published), it has been demonstrated that prone position (pp) decrease, by almost 50%, the respiratory work of breathing and improve the respiratory mechanics in infants hospitalized in intensive care units for bronchiolitis. investigators hypothesize that prone position, during high flow nasal cannula (hfnc), would significantly reduce the use of non-invasive ventilation (ncpap and others) or invasive ventilation, as compared to supine position during hfnc, in infants with moderate to severe viral bronchiolitis.


Eligibility criteria:
inclusion criteria: * infant under 6 months * hospitalized in critical care unit (continuous monitoring unit or intensive care unit) * with a clinical diagnosis of acute viral bronchiolitis (criterion of the american academy of pediatrics 2014) * m-wcas score ≥ 3 and / or hypercapnic acidosis with ph \ 50mmhg (6.7 kpa) * informed consent signed by at least one of the parents with oral consent of the other parent (and / or legal guardian) recorded in the medical file. exclusion criteria: * infant admitted with criteria for invasive or non-invasive ventilation (hypercapnic acidosis with ph \ 92% whatever the fio2 and/or more than 3 significant apneas per hour and/or severe consciousness disorder) * patient already positioned in the prone position before randomization * significant comorbidities with a history of respiratory pathology (bronchodysplasia with ventilatory support), ear nose and throat pathology (pharyngolaryngomalacia) or neuromuscular and / or hemodynamically significant congenital heart disease. * contraindication to prone position : recent abdominal surgery (laparoschisis or omphalocele) or recent sternotomy * patient who is not affiliated (or does not benefit from) to a national social security system

Keywords: viral bronchiolitis prone position high flow nasal cannula noninvasive ventilation randomized controlled trial
goal of open lung ventilation in donors

Conditions: Brain Death; Organ Donation; Organ Transplant Failure or Rejection

Summary: the primary goal of this study is to assess whether ventilation of deceased organ donors with an open lung protective ventilatory strategy will improve donor lung utilization rates and donor oxygenation compared to a conventional ventilatory strategy.

deceased organ donors are maintained on life support including mechanical ventilation during the time between brain death and organ procurement. the optimal mode of mechanical ventilation for deceased organ donors has not been definitively established. since deceased organ donors may develop atelectasis leading to impaired oxygenation, an open lung protective ventilatory strategy with higher positive end expiratory pressure (peep), lower tidal volume and recruitment maneuvers has been hypothesized to be beneficial. favorable outcomes were observed in a european clinical trial comparing open lung protective ventilation (olpv) to a conventional ventilatory strategy in terms of donor oxygenation and lung utilization for transplantation (mascia l et al, journal of the american medical association 2010). however, donor management procedures in europe are much shorter in duration compared to the us and it is not clear that these findings are generalizable to the us donor management environment. the gold trial will test the effect of an olpv strategy compared to conventional ventilation (cv) in the us donor management environment. this multi center trial will enroll 400 brain dead organ donors randomized into 1 of 2 treatment arms. after randomization, mechanical ventilation will be protocolized according to treatment arm with one arm receiving control ventilation (cv) utilizing standard donor network west (dnw) protocols and the other arm receiving the olpv strategy with higher positive end expiratory pressure (peep) and lower tidal volume compared to cv. the primary outcomes is donor lung utilization for transplantation.

Eligibility criteria:
inclusion criteria: * brain death * authorization for research * ≥13 years of age exclusion criteria: * arterial/inspired oxygen ratio (pao2/fio2) ≤ 150 mmhg * pao2/fio2 ≥ 400 mmhg * bmi \> 40 * hepatitis b surface antigen positive * hepatitis c positive * failure to complete donation process * hemodynamic instability
trial of dacarbazine with or without genasense in advanced melanoma

Conditions: Melanoma

Summary: this study is being performed to prospectively determine whether dacarbazine plus genasense is significantly better than dacarbazine plus placebo in chemotherapy-naive patients with advanced melanoma and low baseline ldh (ldh less than or equal to 0.8 times the upper limit of normal). ldh is a biomarker strongly associated with improved outcomes in a recent trial of dacarbazine plus genasense.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of melanoma * progressive disease that is not surgically resectable, or metastatic stage iv * low-normal ldh, defined as ≤ 0.8 times the upper limit of normal * no prior chemotherapy * measurable disease * ecog performance status ≤ 1 * at least 4 weeks and recovery from effects of major prior surgery or other therapy, including immunotherapy, radiation therapy, or cytokine, biologic or vaccine therapy * prior immunotherapy allowed * adequate organ function exclusion criteria: * prior cytotoxic chemotherapy, including regional perfusion, or prior genasense treatment * primary ocular or mucosal melanoma * bone-only metastatic disease * history or presence of brain metastasis or leptomeningeal disease * significant medical disease other than cancer * organ allograft

Keywords: melanoma advanced melanoma malignant melanoma metastatic melanoma skin cancer genasense oblimersen antisense bcl-2 antisense g3139 dacarbazine
immediate neurophysiological effects of pens on radial nerve in patients with lateral epicondylalgia

Conditions: Tennis Elbow

Summary: lateral epicondylalgia is a common musculoskeletal condition that approximately affects 1-3% of the general population. several authors have found greater mechanical pain sensitivity in the radial nerve when compared with healthy subjects. radial tunnel syndrome exhibits a similar clinical presentation to lateral epicondylalgia. percutaneous electrical stimulation has shown reduce pain in several conditions. percutaneous electrical stimulation on the radial nerve could cause an important relief in lateral epicondylalgia. hypothesis: percutaneous electrical stimulation on radial nerve plus in patients with lateral epicondylalgia is better than sham percutaneous electrical stimulation

randomized, double-blind, placebo controlled clinical trial, using percutaneous electrical nerve stimulation (pens). pens is technique to provide a transcutaneous electrical nerve stimulation current throughout needling filaments place close to the nerve. study aims: aim #1: the primary aim of the study is to compare the immediate effect of a single session of pens on pressure pain sensitivity as measured by pressure pain threshold in patients with lateral epicondylalgia with random assignment to two treatments: pens or sham pens aim #2: the secondary aim of the study is to compare the immediate effect on pain free grip strength, on intensity of pain as measured by visual analogue scale (vas) in patients with lateral epicondylalgia with random assignment to two treatments: pens or sham pens.

Eligibility criteria:
inclusion criteria: * lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test: 1. pain during palpation of lateral epicondyle 2. pain on resisted wrist extension 3. pain on resisted middle finger extension 4. pain during hand-grip exclusion criteria: * history of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb. * neurological disorders, inflammatory and/or degenerative diseases. * having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received percutaneous electrical stimulation as a treatment before. * cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy. * contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases). * contraindications of electrical current application

Keywords: lateral epicondylalgia lateral epicondylitis lateral elbow tendinopathy lateral elbow pain percutaneous electrical nerve stimulation
a study of oral pf-02341066, a c-met/hepatocyte growth factor tyrosine kinase inhibitor, in patients with advanced cancer

Conditions: Non-Small Cell Lung Cancer ALK-positive; Non-Small Cell Lung Cancer c-Met Dependent; Non-Small Cell Lung Cancer ROS Marker Positive; Systemic Anaplastic Large-Cell Lymphoma; Advanced Malignancies Except Leukemia

Summary: pf-02341066 may work in cancer by blocking the cell growth, migration and invasion of tumor cells. pf-02341066 is a new class of drugs called c-met/hepatocyte growth factor receptor tyrosine kinase inhibitors. this compound is also an inhibitor of the anaplastic lymphoma kinase (called alk) tyrosine kinase and ros receptor tyrosine kinases. this research study is the first time pf-02341066 will be given to people. pf-02341066 is taken by mouth daily.


Eligibility criteria:
inclusion criteria: * advanced malignancies (except leukemias), histologically proven at diagnosis; histologically confirmed advanced malignancies that are known to be sensitive to pf-03241066 inhibition, e.g. alk, c-met and ros * solid tumors must have measurable disease (recommended phase 2 dose cohort patients with non-measurable disease may enter on a case-by-case basis); not required for ddi sub-studies. * adequate blood cell counts, kidney function, liver function and eastern cooperative oncology group (ecog) score of 0 or 1 (for the recommended phase 2 cohort, a ecog score of 2 may be allowed on a case-by-case basis) exclusion criteria: * major surgery, radiation therapy or anti-cancer therapy within 2 to 4 weeks of starting study treatment, depending on the patient cohort * prior stem cell transplant except of patients with neuroblastoma, lymphoma or myeloma * active or unstable cardiac disease or heart attack within 3 months of starting study treatment

Keywords: crizotinib dose-finding drug-drug interaction alk rearrangements c-met mutations or amplifications c-met dependent tumors ros1 rearrangements c-met exon 14 deletion c-met exon 14 skipping c-met exon 14 alterations
oval-8 splinting versus standardized treatment with tee pee or forearm based thumb spica splinting

Conditions: Carpometacarpal (CMC) Joint Arthritis

Summary: the oval-8 splint has been developed for many uses in finger pathology and trauma. it has not, however, been used to treat thumb carpometacarpal (cmc) joint arthritis. when treating thumb cmc joint osteoarthritis, splinting is a very widely used and supported treatment option for non-operative management. many studies have been performed showing that thumb spica splinting in abduction with either a hand based or forearm based splint improves pain. this study aims to compare the effects of a novel splinting approach with oval-8 splints for the hyperextended thumb interphalangeal (ip) joint vs. standardized treatment with tee pee splinting (hand based thumb spica) or forearm thumb spica splinting on pain and function of patients with thumb cmc joint arthritis. this is a pilot study will address the following hypothesis: splinting of the hyperextended thumb ip joint with oval-8 splints will lead to increased dash scores and decreased pain on physical exam compared to splinting with thumb spica splints in patients with thumb cmc arthritis.

after informed consent is obtained and the patient has met all of the inclusion criteria and non of the exclusion criteria, the patient will be assigned a study id number. the patient will be randomized with a ratio of 1:1:1 to a splint treatment with either a forearm thumb spica splint, tee-pee splint or oval- 8 splint at the time of initial visit to orthopaedic hand clinic (week 1 visit). the patient will be fitted and provided with the appropriate splint by orthopaedic physician. baseline radiographs (3 views anterior-posterior, lateral and oblique) and data points will be gathered from initial clinic history and physical, as performed per normal clinical protocol: arthritis grade, hand involved, dominant hand, interphalangeal (ip) extension, mcp extension, pinch strength, grip strength, pain scale, location of pain, dash scores, analgesic use, and work/hobby activity. additionally, demographic data including age, gender and race/ethnicity will be gathered and patient will be asked to repeat pinch and grip tests with study splint applied and asked to repeat assessment of pain scale.

Eligibility criteria:
inclusion criteria: * carpometacarpal (cmc) osteoarthritis * greater than or equal to 35 degrees of passive thumb interphalangeal (ip) joint hyperextension on physical exam exclusion criteria: * history of hand surgery to affected hand * prior surgical treatment for thumb carpometacarpal (cmc) osteoarthritis. * patients with diagnosis of an autoimmune arthritis and post traumatic arthritis

Keywords: osteoarthritis thumb spica splint oval-8 splint tee-pee splint