Kornimate/medical-research-clean huggingface dataset:
protocols of ivf/icsi in poor responders

Conditions: Infertility, Female

Summary: comparing two ovarian induction protocols in poor responders in ivf/icsi cycles

the two groups of poor responders are randomized into either; a minimal dose stimulation protocol involving letrozole, recombinant fsh and gnrh antagonist versus a microflare conventional protocol with ocp, gnrh agonist and high dose recombinant fsh, in their ivf/icsi cycles, primary outcome will be the number of oocytes retrieved.

Eligibility criteria:
inclusion criteria: 1- more than 1 year of infertility 2 - poor ovarian responder according to the bologna criteria: 1. advanced maternal age 2. previous poor ovarian response 3. abnormal tests of ovarian reserve (afc \< 5-7, amh \<0.5-1.1 ng/ml) exclusion criteria: 1. age \> 43 years 2. baseline fsh \>15 miu/ml 3. previous ovarian surgery 4. ovarian endometrioma 5. uterine anomaly or myoma 6. any medical disorder 7. any hormonal disorder eg. hyperprolactinemia 8. bmi \> 30 kg/m2 9. severe male factor
screening of cancer patients to assess impact of covid-19

Conditions: Covid-19; Cancer

Summary: the purpose of this study is to investigate the impact of covid -19 in the cancer patient population. this will be done by looking at the rate of asymptomatic covid-19 infection in cancer patients receiving cancer therapy, as well as their immune response. this is a sub-study of the u-deploy study: uhn umbrella trial defining coordinated approach to pandemic trials of covid-19 and data harmonization to accelerate discovery. u-deploy helps to facilitate timely conduct of studies across the university health network (uhn) and other centers.

given increasing community transmission and the possibility of asymptomatic carriage of virus, it is important to study whether asymptomatic shedders of virus are playing a role in propagating the pandemic. there is currently little data available regarding cancer patients, yet, this population may be particularly susceptible to the covid-19 infection. despite the cancer patient population being at higher risk of covid-19, no systematic screening has been established and no biomarkers have been identified to determine which patient is at higher risk. this study will screen patients on active cancer therapy for covid-19 as a standard of care or a research nasopharyngeal test. blood samples may also be taken to assess any patient response to the virus and optional saliva samples may also be taken to assess the feasibility of using patient saliva for detection of sars-cov-2 virus in patients with impaired saliva production (eg. secondary to cancer treatments such as radiation, chemotherapy, and/or surgery).

Eligibility criteria:
inclusion criteria: * patients having an active malignancy who are planned to start therapy within 6 weeks of consent or are receiving a treatment for active malignancy. * the patient falls under either of the following categories: 1. asymptomatic for covid-19 (as per daily screening at the hospital entrance). 2. has symptoms similar to those of covid-19 (e.g. fever or flu-like symptoms such as cough or shortness of breath) that are assessed by the overseeing investigator as being related to disease and unrelated to covid-19 infection. note: patients who recovered from previous covid-19 infection will be eligible. * no contraindication to performing a np swab and blood work. exclusion criteria: * any patients with fever, or flu-like symptoms assessed by the investigator to be related or potentially related to covid-19 infection will not be eligible. * eastern cooperative oncology group (ecog) performance status of 3-4
using lay health advisors to improve hypertension management

Conditions: Hypertension

Summary: hypertension disproportionately affects and is inadequately controlled among african american and poor populations. the investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension.

hypertension disproportionately affects and is inadequately controlled among african american and poor populations. health providers generally lack the skills and resources to address social contextual factors (i.e. health and community services, social networks, social stressors, physical environment, and economic resources) that influence management of hypertension. instead, providers tend to focus on adjusting antihypertensive medication prescriptions and exhorting patients to exercise and eat better. the investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension. helping patients address these barriers may lead not only to improved blood pressure but also to increased survival, reduced organ damage, and decreased health care costs. this project may also serve as a model of healthcare delivery innovation that could be used to address other health disparity conditions.

Eligibility criteria:
inclusion criteria: * at least 2 outpatient blood pressures with systolic \>140 or diastolic \>90 mm hg in last 6 months. separate occurrences at least 1 day apart * age 18-59 years * non-diabetic * preserved kidney function (glomerular filtration rate \>60 ml/min) * english speaking exclusion criteria: * mentally incompetent * pregnant * terminal illness * active substance abuse * documented coronary, peripheral arterial, or cerebrovascular disease

Keywords: hypertension community health workers community-based participatory research health equity
study of forteo use in subjects in the community setting

Conditions: Osteoporosis

Summary: the purpose of this study is to evaluate the long-term effectiveness, safety, and tolerability of forteo in a larger, more diverse "real world" population than studied in clinical trials

subjects will be followed through a course of forteo therapy for up to 24 months and for an additional 24 months after forteo treatment is stopped. subjects may participate in this study for up to 48 months. all aspects of patient care, including diagnostic and therapeutic interventions, will be chosen and conducted at the discretion of the participating study physician according to their clinical judgment and the local standard of medical care.

Eligibility criteria:
inclusion criteria: * men and women who are judged by the study physician to be suitable for forteo therapy. the forteo product labeling specifies those individuals diagnosed with osteoporosis who are considered to be at high risk for fracture exclusion criteria: * subjects who have an increased baseline risk for osteosarcoma. these include paget's disease of bone, pediatric populations and young adult patients with open epiphyses, prior external beam or implant radiation therapy involving the skeleton * subjects who have administered forteo or pth therapy for more than two weeks directly before study entry * subjects who have completed a course of forteo or pth therapy of at least 18 months duration before study entry
microvascular injury and distal thrombosis in covid-19

Conditions: SARS-CoV-2 Infection

Summary: investigators aimed to better understand the pathophysiology of sars-cov-2 pneumonia in non-critically ill hospitalized patients secondarily presenting with clinical deterioration and increase in oxygen requirement

investigators plan to consecutively enrol 25 patients without clinical or biological evidence for superinfection, without left ventricular dysfunction and for whom a pulmonary embolism was discarded by computed tomography pulmonary angiography. investigators will investigate lung ventilation and perfusion (lvp) by lvp scintigraphy, and, 24 hours later, left and right ventricular function by 99mtc-labelled albumin gated-blood-pool scintigraphy with late (60 mn) tomographic albumin images on the lungs to evaluate lung albumin retention that could indicate microvascular injuries with secondary edema

Eligibility criteria:
inclusion criteria: * non-critically ill patients hospitalized in the covid-19 unit of the centre hospitalier princesse grace of monaco * presenting with a sudden clinical deterioration defined by a respiratory rate impairment and/or a rise of oxygen flow to reach a peripheral capillary oxygen saturation (spo2) of more than 95% during at least 48 hours * a diagnosis of pulmonary embolism was discarded by ct pulmonary angiography * no clinical or biological (procalcitonin levels) evidence of lung superinfection * without clinical evidence for lv dysfunction exclusion criteria: * non confirmed covid-19 pneumonia according to the who guidance by a positive result of rt-pcr assay of nasal and pharyngeal swabs, * patients without peripheral pulmonary ground-glass opacities or air-space consolidation on their chest ct scan at admission and common laboratory findings including lymphocytopenia, eosinopenia, significantly elevated markers of organ inflammation such as fibrinogen and c-reactive protein. * patients could not be included if their medical condition was unstable or precluded a safe transfer to the nuclear medicine department, if they were under mechanical ventilation (either non-invasive or invasive), if they required critical care unit, or in case of a pregnancy.

Keywords: lung thrombosis pulmonary embolism lung scintigraphy alveolar albumin uptake
virtual interactive 3d modelling to improve outcomes in robotic-assisted partial nephrectomy

Conditions: Kidney Tumor

Summary: the primary objective is to determine if 3d modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.

3dpn is a prospective, multicentre, randomised, controlled, two-armed, open trial to compare the 3d modelling with the 2d modelling in robotic-assisted partial nephrectomy. according to the randomisation the 3d or 2d modelling is used for patient information (before intervention) and for partial nephrectomy. a six-month follow-up visit is provided.

Eligibility criteria:
inclusion criteria: * patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the davinci surgical system * ct scan with contrast medium available * age ≥ 18 years * written informed consent exclusion criteria: * history of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation) * horseshoe kidney * previous malignancy with ongoing or planned nephrotoxic chemotherapy * patient is immunosuppressed (e.g., organ transplantation, leukaemia) * tumor thrombus in vena renalis or vena cava inferior * existing renal insufficiency gfr \< 15 ml/min/1.73m2 * severe cognitive impairment * pregnancy or lactation or women with desire for children * patients under legal supervision or guardianship * unable to give informed consent or suspected lack of compliance * patients who refuse to data collection and storage for the main study

Keywords: davinci surgical system robotic-assisted partial nephrectomy kidney tumours
the clinical and laboratory phenotypes of severe asthma patients in clalit health services haifa

Conditions: Asthma

Summary: asthma is a chronic illness characterized by inflammation of the airways. severe asthma is defined in the literature as asthma not controlled by medication. in recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc. our aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.

study measures will include the following: * asthma demographic and symptoms questionnaire * validation of proper inhaler technique * height, weight measurements * forced spirometry and reversibility testing * dlco * fractional excretion of no in exhaled breath * chest and sinus ct * induced sputum analysis * complete blood count, electrolytes, immunoglobulin e, aspergillus specific ige * skin allergy testing

Eligibility criteria:
inclusion criteria: 1. presence of asthma- typical symptoms and signs accompanied by either: a. obstruction in spirometry, or- b. positive methacholine test 2. regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (laba). 3. lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms. exclusion criteria: 1. presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (copd) 2. lack of adherence to medical therapy
impact of pcsk9 inhibition on clinical outcome in patients during the inflammatory stage of the covid-19

Conditions: Sars-CoV-2 Infection

Summary: the impact-sirio 5 is a randomized, double-blind, phase iii clinical trial aimed to evaluate safety and efficacy of pcsk9 inhibition on clinical outcome in patients during the inflammatory stage of the covid-19. during the hospitalization participants will be randomized in a 1:1 ratio to either receive pcsk9 inhibitor (evolocumab) or to receive placebo (saline solution). furthermore, all people included in the study will be treated in accordance to the latest recommendations on the treatment of patients infected with sars-cov-2.


Eligibility criteria:
inclusion criteria: 1. written informed consent for participation in the study 2. male and female age 18 or more at the time of signing the informed consent 3. sars-cov-2 infection confirmed by real-time reverse transcription polymerase chain reaction (rt-pcr) 4. covid-19 pneumonia with a typical radiological changes 5. pao2/fio2 ratio less than or equal to 300 6. covid-19 pneumonia in cytokine storm with elevated serum level of interleukin-6 exclusion criteria: 1. use of fibrates other than fenofibrate or fenofibric acid 2. known active infections or other clinical condition that contraindicate pcsk9 inhibitors 3. known systemic hypersensitivity to pcsk9 inhibitors 4. estimated glomerular filtration rate \<30 ml/min/1.73 m2 5. absolute neutrophil count (anc) less than 2000/mm3 6. a platelet count less than 50000/mm3 7. creatine kinase (ck) greater than 3x upper limit of normal (uln) 8. aspartate aminotransferase (ast) or alanine aminotransferase (alt) greater than 3x upper limit of normal (uln) 9. not expected to survive for more than 48 hours from screening 10. unrelated co-morbidity with life expectancy \<3 months. 11. pregnancy 12. any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study 13. patient being treated with other immunomodulators (except for glucocorticoids). 14. patient included in any other interventional trial.

Keywords: covid-19 sars-cov-2 pneumonia pcsk9 inhibitor
a phase i study of recombinant cd4(rcd4) in patients with aids and aids-related complex

Conditions: HIV Infections

Summary: to determine the safety profile and maximum tolerated dose (mtd) of recombinant soluble human cd4 (rcd4) therapy in patients with aids or aids related complex (arc). to obtain a preliminary indication of the antiviral effects of rcd4 in patients with aids and arc. to measure steady state serum levels of rcd4 following continuous infusion therapy.


Eligibility criteria:
inclusion criteria patients must have: * hiv-1 seropositivity. * diagnosis of aids or aids related complex (arc). * failure to tolerate or respond to zidovudine (azt) or decided to decline azt therapy. * the ability to sign a written informed consent form prior to treatment. * a willingness to abstain from all other experimental therapy for hiv infection during the entire study period. * a life expectancy of at least 3 months. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * serious active opportunistic infections. * malignancies other than kaposi's sarcoma. concurrent medication: excluded: * zidovudine (azt). * corticosteroids. * nonsteroidal anti-inflammatory agents (nsai). * other experimental therapy. patients with the following are excluded: * serious active opportunistic infections. * malignancies other than kaposi's sarcoma. prior medication: excluded within 3 weeks of study entry: * zidovudine (azt). * chemotherapy. * immunomodulators. * other experimental therapy.

Keywords: acquired immunodeficiency syndrome antigens, cd4 aids-related complex
a non-interventional cohort safety study of patients with hattr-pn

Conditions: Hereditary Transthyretin Amyloidosis With Polyneuropthy

Summary: this is a prospective, non-interventional, long-term, multinational cohort safety study of patients with hereditary transthyretin amyloidosis with polyneuropathy (hattr-pn). the overarching goal of this study is to further characterize the long-term safety of tegsedi (inotersen) in patients with hattr-pn under real-world conditions.

study rationale: hattr-pn is an inherited, progressive, fatal disease caused by misfolded transthyretin (ttr) proteins that accumulate as amyloid fibrils predominantly in the peripheral nerves, heart, gastrointestinal tract, and other organs. hattr-pn is a rare disease and there are no large epidemiological studies that reliably provide an indication of its prevalence. the worldwide distribution is unequal, with higher rates in portugal, japan, brazil, northern sweden, and the us. current estimates suggest there may be 10,000 afflicted patients worldwide. tegsedi (inotersen) is an antisense oligonucleotide inhibitor of human ttr protein synthesis. in europe and canada, tegsedi is indicated for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hattr). in the us, tegsedi is indicated for treatment of the polyneuropathy of hereditary ttr-mediated amyloidosis in adults. efficacy has been demonstrated in patients with hattr-pn, as reflected by a slowing or reversal of disease progression. research question: the overarching goal of this study is to further characterize the long-term safety of tegsedi in patients with hattr-pn under real-world conditions. population: patients in europe, us, and canada will be enrolled from centers that manage patients with hattr-pn. physicians participating in the study will be instructed to invite all patients who meet study eligibility criteria to enroll until the enrollment period is closed.

Eligibility criteria:
inclusion criteria: 1. either: 1. tegsedi exposed cohort: patients diagnosed with hattr-pn who have taken any dose of tegsedi within 25 weeks prior to enrollment 2. tegsedi unexposed cohort: patients diagnosed with hattr-pn who have not taken any dose of tegsedi within 25 weeks prior to enrollment and are eligible for tegsedi treatment per applicable product label 2. clinically managed in canada, europe, or the us 3. have provided appropriate written informed consent exclusion criteria: * none

Keywords: hereditary transthyretin amyloidosis hattr-pn hattr amyloidosis
e-learning on the trainees' ability to diagnose and treat acute otitis media among children

Conditions: Ear Infection

Summary: an e-learning module to teach how to evaluate ears in children was recently designed. the aim of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose ear infection in clinical setting.

background and aims: acute otitis media (aom) is one of the most common infections of childhood and a leading cause for antibiotics prescription. in a previous study performed at a tertiary care pediatric emergency department, residents were found to have as low as a 52% sensitivity and 74% specificity for the diagnosis of aom. seeing this as an opportunity for substantial improvement, an e-learning module on aom intended for medical students was designed. the primary objective of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose aom. the secondary objectives are to assess the preferred learning modality, to evaluate if our e-learning module is associated with improved knowledge on aom and with better retention at 3 weeks. methods: this will be a randomized trial performed at a single tertiary care pediatric emergency department. the participants will be third- and fourth-year medical students doing a general pediatrics rotation. the participants will be randomized to completing the e-learning module at the beginning of their rotation or to receive a 2-hour lecture on the topic of aom. the primary outcome will be ear examination accuracy measured during their shifts at the emergency department. to measure this, participants will be asked to examine a minimum of five children at risk for aom, defined as 12-60 months old of age with fever or respiratory symptoms. they will be questioned about the presence or absence of aom in each examined ear. attending physicians will control all exams and write down their diagnosis. the primary analysis will be the difference in diagnostic accuracies between the trainees who completed the e-learning module and those who received the lecture. a sample size of 80 medical students each examining a minimum of five children would provide a power of 90% and an alpha-value of 0,05 to demonstrate a difference of 15% in the aom diagnostic accuracies of medical students who have completed an e-learning module on aom compared with those receiving a standard lecture on the same topic.

Eligibility criteria:
inclusion criteria: * third or fourth-year medical students * doing their 6-week rotation in general pediatrics at sainte-justine hospital * participation at the introductory meeting on the first day of the rotation exclusion criteria: * no shifts scheduled at the emergency department during general pediatrics rotation * student already recruited in a previous rotation * student who evaluated less than 10 ears for the study will not be included in the primary analysis
mindfulness meditation versus clinical hypnosis for acute, experimental pain

Conditions: Mindfulness Meditation; Clinical Hypnosis

Summary: this trial aims to determine the effects and mechanisms (mediators and moderators) of brief training in mindfulness meditation versus clinical hypnosis on acute, experimental pain.

participants (n=200 with complete data) will be healthy undergraduate students or community-based individuals. an experimental, randomised trial will be implemented, with participants randomly assigned to either five daily, 20-minute mindfulness meditation sessions or clinical hypnosis sessions. repeated measures and experimental pain manipulation will be implemented. aim 1 is to examine the effects of these two treatments on experimental pain outcomes. aim 2 is to examine the moderators of these effects. aim 3 is to determine the mediators underlying improved experimental pain outcomes. results will refine theory and will inform the future streamlining of treatments to target those mechanisms shown to be of most critical importance.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * able to read, speak and understand english. exclusion criteria: * pregnancy, heart or vascular disease, raynaud's disease, sickle cell disease, seizure disorder, high blood pressure, or diabetes; * experience of recurrent fainting spells; * report of a chronic pain condition; * use of alcohol and/or pain medication in the last 24-hours; * currently receiving psychiatric care; * problems with allergic skin reactions or excessive bruising; * previous participation in a cold pressor experiment. * all participants will be asked to consume a fruit box drink prior to the cold pressor to prevent vasovagal reactions. these exclusion criteria are standard when using a cold pressor task in a healthy undergraduate population and ensure safe procedures to mitigate any potential risks.

Keywords: mindfulness meditation hypnosis acute pain experimental pain mechanisms