Kornimate/medical-research-clean huggingface dataset:
triple in asthma high strength versus ics/laba hs and tiotropium (trigger)

Conditions: Asthma

Summary: the purpose of this study is to evaluate the superiority of chf 5993 200/6/12.5 µg pmdi (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) versus chf 1535 200/6 µg pmdi (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate) and to compare the effect of chf 5993 200/6/12.5 µg pmdi vs chf 5993 200/6/12.5 µg plus open-label tiotropium 2.5µg, in terms of lung functions parameters and rate of exacerbations, as well as to assess its safety and some health economics outcomes.


Eligibility criteria:
inclusion criteria: * history of asthma ≥ 1 year and diagnosed before 40 years old * uncontrolled asthma with double therapy only on high doses of inhaled corticosteroid (ics) in combination with long-acting beta2 agonist (laba) with acq-7 (asthma control questionnaire) ≥1.5 * pre-bronchodilator fev1 \<80% of the predicted normal value * positive reversibility test * at least 1 documented asthma exacerbation in the previous year exclusion criteria: * pregnant or lactating women * diagnosis of chronic obstructive pulmonary disease (copd) * patients with any asthma exacerbation or respiratory tract infection in the 4 weeks prior screening * current smoker or ex-smoker (\>= 10 packs year) * any change in dose, schedule or formulation of ics + laba combination in the 4 weeks prior screening

Keywords: asthma, anticholinergics, triple combination
idh1 and oct4 in high grade astrocytoma

Conditions: High Grade Astrocytoma

Summary: observation of idh1 and oct4 markers level and high grade astrocytoma patients prognosis after excision.

explore the relationship between prognosis and idh1 and oct4 biomarkers after high grade astrocytoma excision , according to progression free survival and overall survival , in prospective and retrospective samples.

Eligibility criteria:
inclusion criteria: * patients of high grade astrocytic glioma patients fit for surgery exclusion criteria: * patients of low grade glioma patients unfit for surgery
to evaluate efficacy and safety of serplulimab + chemotherapy (carboplatin- etoposide) in us patients with es-sclc

Conditions: Extensive Stage Small Cell Lung Cancer

Summary: this is a randomized, open-label study of serplulimab plus chemotherapy (carboplatin-etoposide) in comparison with atezolizumab plus chemotherapy in previously untreated us patients with es-sclc. subjects in this study will be randomized to arm a or b at 1:1 ratio as follows: * arm a (serplulimab): serplulimab + chemotherapy (carboplatin-etoposide) * arm b (control): atezolizumab + chemotherapy (carboplatin-etoposide)


Eligibility criteria:
inclusion criteria: voluntary participation in clinical studies. male or female aged ≥ 18 years at the time of signing the icf. histologically or cytologically diagnosed with es-sclc (according to the veterans administration lung study group staging system). no prior systemic therapy for es-sclc. at least one measurable lesion as assessed according to recist 1.1 within 4 weeks prior to randomization. major organs are functioning well. every effort should be made to provide tumor tissues for the determination of pd-l1 expression. an ecog ps score of 0 or 1. an expected survival ≥ 12 weeks. subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment. participant must keep contraception. exclusion criteria: histologically or cytologically confirmed mixed sclc. known history of severe allergy to any monoclonal antibody. known hypersensitivity to carboplatin or etoposide. patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia. pregnant or breastfeeding females. patients with a known history of psychotropic drug abuse or drug addiction. patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.

Keywords: extensive stage small cell lung cancer anti-pd-1 monoclonal antibody
clarifying the optimal application of slt therapy trial

Conditions: Glaucoma and Ocular Hypertension

Summary: the goal of this study is to understand if slt performed at low energy is as effective as slt performed at standard energy, and also to see if repeating slt at low energy once a year will prevent or delay the need for daily eye drop medications better than waiting for slt to wear off before repeating it.


Eligibility criteria:
inclusion criteria: 1. age 18 or older and in good health 2. each eye with one of the following qualifying diagnoses (diagnoses may differ between eyes): 1. high-risk ocular hypertension (oht): iop \> 21 mmhg without glaucomatous optic neuropathy (excavation, diffuse or focal thinning or notching of the neuroretinal rim, visible nerve fiber layer defects, or asymmetry of the vertical cup-to-disc ratio of \>0.2 between eyes) 2. mild primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation better than -6.0 db with no points in the central 5° \<15 db (see figure on next page) 3. moderate primary open-angle glaucoma: glaucomatous optic neuropathy, visual field mean deviation equal to or worse than -6.0 db but no worse than -12.0 db and no central 5° points \<15 db or mean deviation -12.0 db or better with 1 central 5° points \<15 db (see figure on next page). 3. each eye with bcva 20/200 (uk 6/60) or better exclusion criteria: 1. use of topical iop-lowering medications for more than 6 cumulative months at any time in the past 5 years (this is a modification implemented during active enrollment) 2. any history of iop-lowering laser (prophylactic iridotomy not included) or surgical procedure 3. advanced poag in either eye (worse than moderate poag as defined above) 4. glaucoma other than poag (including pigmentary and pseudoexfoliation glaucoma) in either eye 5. mean iop \> 35 mmhg at either the screening or baseline visit in either eye 6. narrow or closed angle (shaffer grade 0, 1, or 2) in either eye 7. contraindications to slt or any other study intervention 8. any corneal pathology that would preclude accurate assessment of iop by goldmann tonometry in either eye 9. any intraocular surgical procedure within the past 6 months in either eye 10. inability to attend all scheduled study visits 11. pregnant or planning to become pregnant in the next 4 years

Keywords: glaucoma selective laser trabeculoplasty clinical trial
repository of phase signals for pulmonary hypertension algorithm development

Conditions: Cardiovascular Diseases; Right Heart Failure; Cardiac Disease

Summary: this study is designed as a repository study to collect resting cardiac phase signals and subject meta data from eligible subjects using the phase signal recorder (psr) prior to right heart cath (rhc). the repository data will be used for the purposes of research, development, optimization and testing of machine-learning algorithms developed by corvista health (formerly analytics 4 life).

male and female subjects will be uniquely and consecutively enrolled into one group to support populating a repository of phase signals. resting phase signals will be collected in all patients who meet inclusion/exclusion criteria and have signed an informed consent form. this study consists of a screening visit, resting phase signal collection (study procedure), and right heart catheterization. in this study, resting phase signals will be acquired in subjects prior to right heart catheterization.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years old; 2. scheduled to undergo right heart catheterization; 3. ability to understand the requirements of the study and to provide written informed consent. 4. normal sinus rhythm (ssr) at time of phase signal collection. exclusion criteria: 1. prior heart valve replacement 2. prior lung or heart transplant 3. infiltrative myocardial disease (amyloid, sarcoid, right ventricular dysplasia); 4. presence of cardiac implantable electronic device (cied), including implantable cardioverter defibrillator (icd), pacemaker (pm), implantable loop recorders and other monitors; 5. implantable neuro-stimulators; 6. congenital heart disease; 7. pregnant or breast feeding; 8. currently taking any type ia, ic or iii antiarrhythmics; 9. any history of amiodarone use; 10. clinically significant chest deformity (e.g., pectus excavatum or pectus carinatum); 11. breast implants; 12. neuromuscular disease if the condition results in tremor or muscle fasciculations.

Keywords: pulmonary hypertension right heart cath
cetuxibab to reduce circulating tumor cells in early stage nsclc

Conditions: Lung Cancer; Surgery; Circulating Tumor Cell

Summary: cetuximab to reduce the amound of circulating tumor cells in early stage nsclc

a multicenter single arm phase ii trial. 40 patients with pathology proven stage i-iiia nsclc that are eligible for resection will be enrolled in this study. all patients will receive one dose of cetuximab prior to surgery. blood will be drawn on multiple timepoints to assess te amount of circulating tumor cells

Eligibility criteria:
inclusion criteria: * 18 years or older * presence of surgically resectable nsclc, stage i-iiia, with curative intent surgery planned. * ≥10 egfr+epcam+ cells detected in the baseline blood sample. * women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. concomitant use of oral and barrier contraceptives is advised. contraception is necessary for at least 6 months after receiving study drug exclusion criteria: * chemotherapy or other anti-cancer therapy including radiotherapy during the study or within 4 weeks prior to the start of the study. * prior anti-egfr mab therapy * other currently active malignancy * immunosuppressive drugs during the study or within 4 weeks prior to the start of te study * expected adverse reactions/allergies or study medication * mental disorder/unable to give informed consent * pregnancy or breast-feeding patients * significant skin condition interfering with treatment * major surgery within 28 days before start of study. * substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results. * any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
multivitamin adherence following bariatric surgery

Conditions: Obesity

Summary: additional micronutrient supplementation is required due to the changes in the gastrointestinal anatomy and physiology following bariatric surgery along with decreased dietary intake and rapid weight loss. good adherence to post-operative vitamins is essential to maintain healthy vitamin levels in the body following bariatric surgery. the hypothesis of this study is that patients receiving a weekly survey intervention will have better adherence to post-operative vitamins.


Eligibility criteria:
inclusion criteria: * planning to undergo a roux en y gastric bypass or sleeve gastrectomy at wake forest baptist health exclusion criteria: * admission for a psychiatric event in the past year * history of nausea and/or significant complaint of post-operative nausea * history of stricture and/or significant complaint of post-operative stricture * history of ulcer and/or significant complaint of post-operative ulcer * history of major depression or psychiatric disorder

Keywords: bariatric surgery multivitamin weight loss adherence
study of selinexor in combination with ruxolitinib in myelofibrosis

Conditions: Myelofibrosis

Summary: this is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in jak inhibitor (jaki) treatment-naïve myelofibrosis (mf) participants. the study will be conducted in two phases: phase 1 (open-label) and phase 3 (double-blind). phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended phase 2 dose (rp2d) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (phase 1a) and a dose expansion part (phase 1b). phase 3 (ongoing), double-blind, placebo-controlled part of the study comparing the efficacy and safety of combination therapy of selinexor + ruxolitinib with combination of placebo + ruxolitinib.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * a diagnosis of primary mf or post-essential thrombocythemia (et) or postpolycythemia- vera (pv) mf. * active symptoms of mf as determined by presence of at least 2 symptoms using the myelofibrosis symptom assessment form (mfsaf) v4.0. * participants with international prognostic scoring system (dipss) risk category of intermediate-1, or intermediate-2, or high-risk. * measurable splenomegaly during the screening period as demonstrated by spleen volume of greater than or equal to (\>=) 450 cubic centimeter (cm\^3) . * eastern cooperative oncology group (ecog) performance status less than or equal to (\<=) 2. exclusion criteria: * more than 10% blasts in peripheral blood or bone marrow (accelerated or blast phase). * previous treatment with jak inhibitors for mf. * previous treatment with selinexor or other xpo1 inhibitors.

Keywords: myelofibrosis selinexor ruxolitinib janus kinase 2 myeloproliferative neoplasms
real-time intervention for suicide risk reduction

Conditions: Suicidal Ideation; Suicide Attempt

Summary: the aim of this study is to determine whether learning three skills for managing negative emotions and receiving reminders via smartphone to practice these skills reduces how often and how intensely one experiences emotional distress and suicidal thoughts.

the present study is a two-arm parallel design rct to test the efficacy of using ecological momentary intervention (emi) to deliver therapeutic content based on the unified protocol for the transdiagnostic treatment of emotional disorders (up) - an evidence-based transdiagnostic cognitive behavioral therapy (cbt) that focuses on delivering adaptive skills for managing strong emotions. participants in this study will be 50 adult psychiatric inpatients with recent suicidal thoughts or behaviors (stbs). participants will be randomized to receive either the control condition, which consists of treatment as usual (tau; n = 25) and 4x/daily daily ecological momentary assessment (ema) of emotions and stbs, or the experimental condition, consisting of tau, 4x/daily ema, 3 brief sessions to deliver cbt skills (mindful emotion awareness, cognitive flexibility, and changing emotional behaviors, all drawn from the up), one discretionary skills booster session, and emi to prompt guided skills practice (n = 25). control participants will receive tau and be prompted to complete 4x/day ema of emotions and stbs for the duration of their hospital stay and the 28-day post-discharge period. participants randomized to the experimental conditions will receive tau plus three brief treatment sessions delivering core up skills content (during inpatient stays) and a discretionary booster session to reinforce treatment sessions that may be offered after discharge via either phone or telehealth. those in the experimental condition will also receive training to use the emi (which prompts guided skills practice), followed by smartphone-based ema/emi for the duration of the inpatient stay and the 28-day post-discharge period.

Eligibility criteria:
inclusion criteria: * adult status (18+ years), * a recent suicide attempt or any report of current suicidal ideation, * the ability to speak and write english fluently, * ownership of and consistent access to an internet-capable smartphone (e.g., an iphone or android phone), and * providing at least one collateral contact in cases where we cannot reach the participant exclusion criteria: - the presence of any factor that impairs an individual's ability to provide informed consent and comprehend and effectively participate in the study including: an inability to speak or write english fluently, the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, or the presence of extremely agitated or violent behavior.

Keywords: suicide suicidal ideation suicide attempt
assessment of gore® synecor biomaterial in focused patient populations and long-term application

Conditions: Hernia, Ventral; Hernia Incisional; Hernia Incisional Ventral

Summary: the syn 20-01 study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of gore® synecor biomaterial in focused patient populations and in long-term application. patients with ventral / incisional hernia amenable to hernia mesh repair will be enrolled into two cohorts (us and eu cohort) and followed-up over the period of 60 months.


Eligibility criteria:
key inclusion criteria - ip cohort: * de-novo ventral/incisional hernia amenable to repair with gore® synecor ip biomaterial * clean wound (cdc wound class i) * mvhwg grade 1 or 2 (modified ventral hernia working group) key exclusion criteria - ip cohort: - wound is either clean-contaminated, contaminated or dirty-infected key inclusion criteria - pre cohort: * de-novo ventral/incisional hernia, with subject anatomy and surgical plan amenable to open surgical repair or minimally invasive surgery with the gore® synecor pre biomaterial placed in a sublay fashion within the preperitoneal space * clean wound (cdc wound class i) * mvhwg grade 1 or 2 (modified ventral hernia working group) key exclusion criteria - pre cohort: - wound is either clean-contaminated, contaminated or dirty-infected

Keywords: hernia repair hernia mesh treatment ventral hernia incisional hernia intraperitoneal preperitoneal
comparison of a weight bearing and a non-weight bearing protocol on osteoporotic women with chronic low back pain

Conditions: Osteoporosis; Low Back Pain

Summary: the effect of exercising in different body positions on bone growth in osteoporotic women is known, but its effect on their function, low back pain, lumbar range of motion and quality of life remains unknown. therefore, the investigators plan to make a comparison of the effect of a weight bearing protocol and a non-weight bearing protocol on osteoporotic women with chronic low back pain. 40 women with osteoporosis and low back pain will be divided into two groups. each group will be given a specific exercise protocol, twice a week for four weeks, 45 minutes each time. the participants will be tested before starting the program, immediately after finishing it and again two months later. the tests will include filling out the roland morris disability questionnaire, the sf-36 quality of life questionnaire, pain measurement by vas (visual analogue scale) and lumbar range of motion measurement by a digital inclinometer. statistical analysis will be made in order to compare the dependent variables between groups.

40 women with osteoporosis and low back pain will be recruited by referral of doctors to the physical therapy clinic in bat-yam, israel. each woman will be tested by one investigator after meeting the criteria of eligibility and after obtaining formed consent . the tests will include filling out the roland morris disability questionnaire, the sf-36 quality of life questionnaire, pain measurement by vas and lumbar range of motion measurement by a digital inclinometer. by order of appearance, each participant will be assigned to one of two groups - weight bearing group or non-weight bearing group. after recruiting at least 3 participants in each group, a different investigator will begin a specific exercise protocol for each of the groups for four weeks - twice a week, 45 minutes each time, a total of 8 sessions. after each participant finishes all 8 sessions, she will be tested for the second time by the first investigator, the same tests as the first time. a third identical test will be preformed two months after finishing the program. after all the participants finish the program statistical analysis will be made in order to compare the dependent variables between groups.

Eligibility criteria:
inclusion criteria: * women with osteoporosis (t score lower than -2.5) * women whom had suffered from non specific low back pain for the last 3 months or more. exclusion criteria: * history of operations in the spine * history of cancer or neurologic disease * history of fractures * previous trauma to the spine * persons whom for any reason cannot sit on a chair or lie on a mattress for 45 minutes
clinical validation of hostdx sepsis™ on nanostring; a prospective observational validation trial

Conditions: Sepsis

Summary: this study will analyze hostdx sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical icu


Eligibility criteria:
inclusion criteria: arm a 1. age \> 18 years 2. suspected sepsis at the time of admission to the icu 3. direct admission from the ed to the icu with suspected/proven sepsis. 4. post-operative icu admission after sepsis source control procedure 5. inpatients admitted to the icu from the ward with suspected sepsis onset. 6. able to provide subject/proxy informed consent within 96h arm b 1. age \> 18 years 2. no suspicion of sepsis at the time of admission to the icu but at high risk for subsequent sepsis onset 3. non-trauma admission from the ed to the icu 4. post-operative icu admission 5. severe trauma admission from the ed (injury severity score \>15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma) 6. inpatients admitted to the icu from the ward for decompensation not initially suspected to be secondary to sepsis. 7. able to provide subject/proxy informed consent within 96h exclusion criteria: 1. pre- or post-transplant patients 2. patients admitted solely for airway monitoring, or vascular/flap check monitoring 3. previous diagnosis of sepsis on index hospitalization. 4. unable to provide informed consent within 96h 5. previously enrolled in the present study.
a study to characterize the abuse liability of alo-02 in healthy, non-dependent, recreational opioid users when alo-02 capsules are crushed and snorted

Conditions: Healthy

Summary: the main purpose of this study is to determine if oxycodone and naltrexone combination capsules (alo-02) have the potential to be abused when they are crushed and snorted.

abuse liability study

Eligibility criteria:
inclusion criteria: * healthy subjects * non-dependent, recreational opioid users. (must use opioid for non-therapeutic purposes on at least 10 occassions within the last year and at least once in the 8 weeks before visit 1 (screening visit). * must have experience with intranasal opioid administration (snorted opioid drugs on at least 3 occassions within the last year before visit 1 (screening visit). exclusion criteria: * diagnosis of substance and/or alcohol dependence * subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder.

Keywords: relative abuse potential study chronic pain oxycodone naltrexone opioid-related disorders drug abusers