Kornimate/medical-research-clean huggingface dataset:
post-resuscitation pneumothorax - analysis of incidence, risk factors and outcome relevance

Conditions: Cardiac Arrest; Pneumothorax; Resuscitation

Summary: in this retrospective study, the investigators seek to investigate the incidence of pneumothorax following possible risk factors, and elucidate its association with outcomes.

this is a retrospective analysis of routine data, collected by a single emergency medical system (ems). adult patients (≥18 years) hospitalised after out-of-hospital cardiac arrest (ohca) who received chest compressions and underwent chest imaging within 12 hours after hospital admission were included. variables and outcomes ascertained are built up of the core elements of the latest version of the utstein resuscitation registry template for ohca. this includes sex, age, aetiology of arrest, response times of the first emergency medical service team and emergency physician, witnessed cardiac arrest, bystander cpr/aed, arrest location, first monitored rhythm, defibrillation time, drugs given, reperfusion attempted and target temperature management. additional variables studied were pre-existing health status represented by the pre emergency status assessment (pesa), history of lung disease, no-flow-time (time from collapse until initiation of cpr), use of a mechanical chest compression device and prehospital cpr duration. the primary outcome is incidence of pneumothorax, secondary outcomes are survival to hospital discharge and favourable neurological condition at hospital discharge defined by a cerebral performance category (cpc) of 1 or 2.

Eligibility criteria:
inclusion criteria: * hospitalized after out of hospital cardiac arrest * chest compressions received * chest imaging within the first 12 hours of admission exclusion criteria: * traumatic cardiac arrest * chest trauma/surgery/pneumothorax one month prior to cardiac arrest
azithromycin for covid-19 treatment in outpatients nationwide

Conditions: COVID-19; SARS-CoV-2

Summary: this individually randomized telemedicine-based trial aims to evaluate the efficacy of a single dose of azithromycin for prevention of progression of covid-19 in patients with a recent positive sars-cov-2 test who are not currently hospitalized.

identification of a safe, effective treatment for individuals with mild or moderate covid-19 that prevents disease progression and reduces hospitalization would reduce the burden on the health system. high dose hydroxychloroquine is being evaluated for sars-cov-2 prevention and covid-19 disease treatment, but has a high risk of a number of potentially severe adverse events. recent evidence has indicated that the broad-spectrum macrolide azithromycin may have some activity against coronaviruses. here we propose an individually-randomized, placebo-controlled trial to determine the efficacy of a single dose of azithromycin for prevention of covid-19. potential participants will undergo remote eligibility screening with study staff prior to enrollment. upon determination of eligibility and signing electronic informed consent documents, participants will be emailed baseline study forms and will be mailed their randomized study treatment. at the end of the study (21 days), participants will be emailed a final study questionnaire. note that there will no contact between study staff and participants in this trial, minimizing risk of infection spread.

Eligibility criteria:
inclusion criteria: * evidence of a positive sars-cov-2 test and test results received within the previous seven days * not currently hospitalized * willing and able to receive study drug by mail * willing and able to do the study questionnaires at baseline, day 3, 7, 14, 21 days via email or over the phone * no known allergy or other contraindication to macrolides * age 18 years or older at the time of enrollment * no known history of prolongation of the qt interval (eg. history of torsades de pointes, congenital long qt syndrome, bradyarrhthmia) * no recent use of hydroxychloroquine within the past 7 days for participants \>55 years of age * not currently taking nelfinavir or warfarin (coumadin) * provision of informed consent * not currently pregnant
comparing two types of needle for oocytes retrieval

Conditions: Infertility, Female; ART

Summary: in the early stages of assisted reproductive technologies (art), oocyte retrieval was performed via laparoscopy, a cumbersome and expensive process requiring general anesthesia. today, transvaginal oocyte retrieval for art is a routine procedure performed under ultrasound guidance. double-lumen retrieval needles, which are capable of flushing ovarian follicles, were developed to overcome the possibility of oocyte retention within the ovarian follicles and retrieval collection system. single lumen needles have been introduced and are routinely used by most groups due to their supposed ability to retrieve the same number of oocytes in a shorter operation time.

after a long period in which humanitas department used double lumen needles for oocytes retrieval in the last four years the choice of the needle is an operator choice, usually influenced by the number of follicles present at human chorionic gonadotropin (hcg) trigger. this prospective randomized controlled clinical trial is designed to highlight differences between double lumen aspiration needle and single lumen needle commonly used in humanitas' clinical practice primarly in terms of number of retrived oocytes per procedure (a). secondary outcomes are the number of punctured follicles (b), the retrieval rate (%) (a/b), the number of follicles at the last ultrasound performed prior to the ovulation trigger (c), the number of retrieved oocytes / number of follicles at trigger-day (a/c), retrieval procedure time (d), single oocyte retrieval time (d/a), the number of mature oocytes (and mii) and complications rate. number of transferred embryos, number of frozen embryos and oocytes, clinical pregnancy rate per retrieval and per transfer (considering the number of pregnancies diagnosed by us visualization of one or more gestational sacs or definitive clinical signs of pregnancy per 100 cycles) and total number of clinical pregnancies with fetal heart beat (confirmed by visualization of one or more embryos with heartbeat at early dating ultrasound), are also evaluated. standard protocols will be used for controlled ovarian hyper stimulation. trans vaginal ultrasound-guided oocyte retrieval will be performed 36 hours ± 2 after hcg injection with the patient under deep sedation. one hundred patients per each needle will be enrolled in this trial.

Eligibility criteria:
inclusion criteria: * ivf/ intracytoplasmatic sperm injection (icsi) cycles; exclusion criteria: * ovarian endometriomas; * severe previous pelvic inflammatory disease with frozen pelvis
comparison of the effectiveness of oral and intratympanic corticosteroid treatments in patients diagnosed with sudden sensorineural hearing loss

Conditions: Sudden Sensorineural Hearing Loss

Summary: the goal of this clinical trial is to learn which one works to treat better in patients with sudden sensorineural hearing loss, oral or intratympanic corticosteroid treatment. the main question it aims to answer is: which corticosteroid treatment is more effective in patients with sudden sensorineural hearing loss, oral or intratympanic? * in our study, it was planned to divide the treatment schemes compared into two groups. group 1 included patients who received oral methylprednisolone treatment daily for 2 weeks (48 mg for the first 7 days, 32 mg for the following 2 days, 16 mg for the 2 days, and 8 mg for the last 3 days). group 2 included patients who received intratympanic 8 mg/2 ml dexamethasone every other day, totally 4 doses. * visit the clinic after diagnose in first week, second week, first month and second month for checkups and tests ( temporal mr, odimetric results)


Eligibility criteria:
inclusion criteria: * 18 years of age and older * unilateral sudden sensorineural hearing loss that developed within 72 hours and has lasted for 14 days or less * affected side pta (500-100-2000-4000hz) should be over 50db * affected side should be at least 30db lower than healthy side in 3 frequencies * hearing should be symmetrical according to patient's statement before sensorineural hearing loss * if used, steroid use should be less than 10 days * cerebellar and vestibular examination should be normal exclusion criteria: * having a history of hearing-related surgery other than a ventilation tube * having a history of previous hearing loss, fluctuating hearing or meniere's disease, chronic inflammatory or suppurative ear disease or cholesteatoma, otosclerosis * being under 18 or over 80 * having a history of physical-barotrauma * presence of structural or retrocochlear pathology in the examination and imaging that would explain the unilateral hearing loss * patients diagnosed with tuberculosis or receiving prophylactic tuberculosis treatment, diabetes mellitus, rheumatological patients, those with atherosclerotic disease, serious psychiatric patients, those receiving chemotherapy, radiotherapy or immunosuppressant treatment, pancreatitis patients, hiv, hepatitis c and b patients, those with chronic renal failure, substance abusers, those with active herpetic lesions, severe osteoporosis patients, those with hearing loss within 4 weeks after general anesthesia, those with a history of head and neck cancer.

Keywords: intratympanic dexamethasone sudden sensorineural hearing loss oral methylprednisolone
compassionate use of omegaven iv fat emulsion

Conditions: Total Parenteral Nutrition-induced Cholestasis

Summary: the purpose of the study is to provide use of omegaven in children with life threatening total parenteral nutrition (tpn) associated cholestasis when all other medical and surgical treatments/therapies have been either ineffective or not feasible in the treatment of this serious condition. this is a compassionate use protocol.


Eligibility criteria:
inclusion criteria: * diagnosis of life threatening pnald * dependent on parenteral nutrition for caloric needs * expected to require pn for at least another 30 days * other causes of liver disease have been excluded * gi/liver service is involved in patient care * standard therapies for the treatment of pnald must have been utilized prior to initiating omegaven. * inpatient at morgan stanley children's hospital of newyork presbyterian hospital * must be at least 2 months of age exclusion criteria: * not inpatient * younger than 2 months of age * expected to be weaned off of parenteral nutrition within 30 days * have other documented causes of liver disease * have signs of proven severe advanced liver disease * allergy to seafood, egg protein and/or previous allergy to omegaven * active coagulopathy, impaired lipid metabolism or severe hyperlipidemia with or without pancreatitis, stoke, embolism, hemodynamic collapse or shock, recent mi, cholestasis due to any reason other than pnald, active new infection at time of initiation of omegaven, hemodynamic instability or if unable to tolerate the necessary laboratory monitoring * must not be enrolled in another clinical trial involving an investigational agent (unless approved by the designated physicians). * parent or legal guardian must be willing to provide consent.

Keywords: total parenteral nutrition-induced cholestasis omegaven liver disease cholestasis fat emulsions
promoting co-parenting and reducing hazardous drinking in new families

Conditions: Parenting; Parent-Child Relations; Drinking, Alcohol; Adjustment

Summary: this study aims to understand if a parenting program that helps couples learn to parent as a team and maintain a healthy lifestyle, such as maintaining safer levels of alcohol use, promotes parent and child health and well-being. programs will be delivered prenatally and postnatally and will include both group classes and individualized sessions. a comprehensive assessment is administered during pregnancy and then at 6 and 12 months of child age. it is hypothesized that targeting intervention during the naturally motivating transition to parenthood may not only provide opportunities for long lasting behavioral change for parents, but also initiate a cascade of protective processes that ultimately reduce risk for negative emotional and behavioral outcomes for children.


Eligibility criteria:
inclusion criteria: * pregnant couples who are cohabitating * parents are 18 years of age or older * health behavior such as moderate to heavy drinking * english speaking exclusion criteria: * plural pregnancy * illicit drug use other than cannabis for either parent

Keywords: parenting couple relationship alcohol and health
sevoflurane in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: ischemic postconditioning can reduce myocardial injury following myocardial infarction. a potential pharmacological agent is the anesthetic sevoflurane. the investigators' hypothesis is that sevoflurane during primary percutaneous coronary intervention (pci) will reduce infarct size.

patients with first stemi that will be treated by primary pci, will be randomized to sedation with sevoflurane during the procedure or to usual care.

Eligibility criteria:
inclusion criteria: * first stemi, presenting within 6 hours after the onset of chest pain * symptoms lasting \> 30 minutes * persistent st-segment elevation \> 0.1 mv in 2 or more contiguous leads exclusion criteria: * hypersensitivity to sevoflurane or other halogenated agents * malignant hyperthermia * cardiac arrest * cardiogenic shock * previous myocardial infarction or coronary bypass surgery * pre-infarction angina * heart failure (nyha iii/iv) * chronic inflammatory disease * severe renal impairment * hepatic dysfunction * use of glyburide

Keywords: acute myocardial infarction postconditioning sevoflurane
safety study of mk-8237 treatment in house-dust-mite allergic adolescents (mk-8237-008)

Conditions: Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Nonseasonal

Summary: the purpose of this study is to evaluate the safety of two doses (6 development units \[du\] and 12 du) of mk-8237 sublingual tablets compared to placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. the primary hypothesis is that at least one dose of mk-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.


Eligibility criteria:
inclusion criteria: * history of physician-diagnosed allergic rhinitis/rhinoconjunctivitis to house dust of at least 6 months duration (with or without asthma) * history of controlled asthma for the prior 1 month if participant has asthma, defined by not exceeding 2 days of symptoms per week; not more than 2 days of albuterol/short acting beta-agonist \[saba\] use per week; and not wakening more than twice a month at night due to asthma symptoms * agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control from screening and through the duration of the study exclusion criteria: * unable to meet medication washout requirements * history of chronic urticaria and/or chronic angioedema within prior 2 years * history of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy due to an unknown cause or to an inhalant allergen * unstable, uncontrolled or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing sabas) at any time within prior 3 months * history of chronic sinusitis during within prior 2 years * pregnant or breast-feeding, or expecting to conceive within the projected duration of the study * known history of allergy, hypersensitivity or intolerance to investigational medicinal products except for dermatophagoides pteronyssinus (d. pteronyssinus) and/or dermatophagoides farina (d. farina) or self-injectable epinephrine * business or personal relationship with investigational site personnel or sponsor who is directly involved with the conduct of the trial
the electrx study - a neurotechnology approach to the treatment of ibd

Conditions: Crohn Disease

Summary: the purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for crohn's disease, in a prospective, single centre, cohort study.


Eligibility criteria:
inclusion criteria: * all patients aged 18 years or older with crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in macroscopic normality. * patients having a reversal of a temporary ileostomy created after previous surgery for crohn's disease may be enrolled provided that the reversal of the ileostomy results in a primary anastomosis and macroscopic normality of the remaining bowel. * patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the intestine. * patients must have proven history of crohn's disease based on (clinical, radiologic, endoscopic and histologic criteria). exclusion criteria: * patients with anastomosis which is endoscopically inaccessible by standard colonoscopy. * patients in whom there is persisting macroscopic abnormality post-surgical resection. * patients with crohn's disease who have an end stoma (ileostomy or colostomy). * patients for whom endoscopy is not suitable due to co-morbidities or unwell clinical state * inability to give informed consent. * inability to obtain access to the anastomosis at colonoscopy. * suspected perforation of the gastrointestinal tract. * patients who are pregnant or breastfeeding.

Keywords: resectional surgery post operative prevention of crohn's recurrence
research of intensive treatment in hormone receptor<10% and human epidermal growth factor receptor-2 negative breast cancer patients with positive lymph node residual disease after neoadjuvant chemotherapy

Conditions: Primary Breast Cancer

Summary: this is a phase iv, single-center, prospective, open-label, randomized,controlled study


Eligibility criteria:
inclusion criteria: * female patients, 18≦age ≦66 years * biopsy proven lymph node positive, estrogen receptor\<10%、progesterone receptor \<10% and human epidermal growth factor receptor-2 negative primary breast cancer * must have completed neo-adjuvant chemotherapy with a standard regimen(containing both anthracycline and paclitaxel) * must have undergone surgery to remove the primary tumor by either a mastectomy or enlarged local excision * postoperative residual positive lymph nodes * adequate recovery from recent surgery * no history of other malignancies * no currently uncontrolled diseased or active infection * not pregnant or breast feeding, and on appropriate birth control if of child-bearing potential * adequate cardiovascular function reserve with a myocardial infarction within the past six month * without radiotherapy and chemotherapy contraindication * adequate hematologic function with: 1. absolute neutrophil count (anc) ≥1500/mm3 2. platelets ≥100,000/ mm3 3. hemoglobin ≥10 g/dl * adequate hepatic and renal function with: 1. serum bilirubin ≤1.5×unl 2. alkaline phosphatase and alanine aminotransferase (alt) ≤2.5 x uln. (≤5 x uln is acceptable in the setting of hepatic metastasis) 3. bun between 1.7 and 8.3 mmol/l 4. cr between 40 and 110 umol/l * knowledge of the investigational nature of the study and ability to give informed consent * ability and willingness to comply with study procedures. exclusion criteria: * known or suspected distant metastases * concurrent malignancy or history of other malignancy * uncontrolled diseases(e.g., heart failure, myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or active infection * geographical, social, or psychological problems that would compromise study compliance * known or suspected hypersensitivity to vinorelbine
a study of tas-303 in female patients with stress urinary incontinence

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of tas-303 in female patients with stress urinary incontinence.

this study is double-blind, placebo-controlled crossover study. the main purpose of this study is to evaluate urethral pressure profile parameters in stress urinary incontinence patients who will receive single dose of tas-303 or placebo.

Eligibility criteria:
key inclusion criteria: * patient has symptoms of stress urinary incontinence (sui) for at least 12 weeks prior to study entry * patient weights at least 45 kg and has body mass index (bmi) range of 18.0-30.0 kg/m2, inclusive, at screening * patient is positive in 1-hour pad weight test at screening * patient has at least 2 incontinence episodes per week. key exclusion criteria: * patient has predominant or primary urge incontinence according to investigator judgment * patient had a prior surgical sui treatment * patient is diagnosed pelvic organ prolapse * patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications. * patient is positive pregnancy test

Keywords: urinary incontinence urinary incontinence, stress lower urinary tract symptoms
expanded access program for aztreonam lysine for inhalation in canadian patients with cystic fibrosis

Conditions: Cystic Fibrosis; Pseudomonas Aeruginosa

Summary: this program is to provide expanded access to aztreonam lysine for inhalation (azli) prior to its commercial availability to patients with cystic fibrosis (cf) and chronic p. aeruginosa airway infection who have limited treatment options and are at risk for disease progression.


Eligibility criteria:
inclusion criteria: * ≥ 6 years of age * patient has cf as diagnosed by one of the following: * documented sweat chloride ≥ 60 meq/l by quantitative pilocarpine iontophoresis test, or * two well characterized genetic mutations in the cftr gene, or * abnormal nasal potential difference with accompanying symptoms characteristic of cf * pa present in expectorated sputum or throat swab culture within 2 months prior to consent * patient must be able to provide written informed consent/assent prior to any study related procedure; parent/guardian must be able to give written informed consent as necessary prior to any study related procedure * at high risk for disease progression as defined by one of the following patient populations: * fev1 ≤ 50 % predicted at the time of consent or * completed participation in cp-ai-006 (through visit 20). patients who withdraw from cp-ai-006 prior to completing all courses of azli and all study visits will not be eligible for this protocol. exclusion criteria: * patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol or dosing requirements * patients with hypersensitivity to any of the components of the drug product * currently enrolled in another clinical trial * pregnant or lactating females

Keywords: cf cystic fibrosis pseudomonas aeruginosa eap expanded access azli aztreonam lysine