Kornimate/medical-research-clean huggingface dataset:
losartan for patients with covid-19 requiring hospitalization

Conditions: Corona Virus Infection; Acute Respiratory Distress Syndrome; SARS-CoV Infection

Summary: this is a multi-center, double-blinded study of covid-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily losartan or placebo for 7 days or hospital discharge.


Eligibility criteria:
inclusion criteria: * presumptive positive laboratory test for covid-19 based on local laboratory standard * age greater than or equal to 18 years of age * admission to the hospital with a respiratory sofa \>=1 and increased oxygen requirement compared to baseline among those on home o2 * randomization within 48 hours of presentation of hospital admission or within 48 hours of a positive test result, whichever is later exclusion criteria: * randomization \> 48 hours of admission order or positive test result, whichever is later * currently taking an angiotensin converting enzyme inhibitor (acei) or angiotensin receptor blocker (arb) * prior reaction or intolerance to an arb or ace inhibitor, including but not limited to angioedema * pregnant or breastfeeding * lack of negative urine or serum pregnancy test * not currently taking a protocol allowed version of contraception: intrauterine device, depo-formulation of hormonal contraception (e.g. medroxyprogesterone acetate / depo-provera), subcutaneous contraceptive (e.g. nexplanon), daily oral contraceptives with verbalized commitment to taking daily throughout the study period; use of condoms or agree to abstain from sexual intercourse during the study. all women of child bearing age enrolled in this fashion will be informed of the teratogenic risks. if enrolled under lar, they will be informed of the risks after regaining capacity. * patient reported history or electronic medical record history of kidney disease, defined as: 1. any history of dialysis 2. history of chronic kidney disease stage iv 3. estimated glomerular filtration rate (egfr) of \< 30ml/min/1.73 m2 at the time of randomization * severe dehydration at the time of enrollment in the opinion of the investigator or bedside clinician * most recent mean arterial blood pressure prior to enrollment \<65 mmhg * patient reported history or electronic medical record history of severe liver disease, defined as: 1. cirrhosis 2. history of hepatitis b or c 3. documented ast or alt \> 3 times the upper limit of normal measured within 24 hours prior to randomization * potassium \>5.0 within 24 hours prior to randomization unless a repeat value was \<=5.0 * treatment with aliskiren * inability to obtain informed consent from participant or legally authorized representative * enrollment in another blinded randomized clinical trial for covid

Keywords: covid-19 corona virus sars-cov-2
efficacy and safety of dex-methylphenidate extended release 30 mg versus 20 mg in children (6-12 years) with attention-deficit/hyperactivity disorder (adhd) in a laboratory classroom setting.

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary: this study will evaluate the efficacy and safety of dex-methylphenidate extended release 30 mg compared to 20 mg in pediatric patients ages 6-12 with attention-deficit hyperactivity disorder (adhd) in a 12-hour laboratory classroom setting.


Eligibility criteria:
inclusion criteria: * male and female subjects aged 6-12 years, inclusive. * subjects meeting the dsm-iv criteria for primary diagnosis of adhd-combined type, or predominantly hyperactive-impulsive subtype, as established by the k-sads-pl (kiddie schedule for affective disorders and schizophrenia-present and lifetime version). if a dsm-iv-defined adhd diagnosis is difficult to establish due to possible co-morbidity, the subject will not be enrolled into the study. * subjects should be on a stabilized total daily dose or nearest equivalent of 40-60 mg methylphenidate or 20-30 mg of d-methylphenidate for at least two weeks prior to screening visit. exclusion criteria: * subject or subject's guardian unable to understand or follow instructions necessary to participate in the study. * diagnosed with or history of a tic disorder or tourette's syndrome. * history of seizure disorder. * the presence of a known medical condition that would preclude the use of methylphenidate. * a history (within the past year) or presence of clinically significant cardiovascular, cerebrovascular, renal, hepatic, gastrointestinal, pulmonary, immunological, hematological, endocrine, or neurological disease. * alt (alanine amino transferase), ast (aspartate amino transferase), ggt (gamma glutamyl transferase) or serum creatinine greater then 2x the uln (upper limit of normal) at screening. * a history of psychiatric illness or substance use disorder (e.g., schizophrenia, bipolar disorder, autism, abuse or dependence, depression, severe conduct disorder or severe oppositional defiant disorder) * subjects who have participated in an investigational trial within the past 4 weeks (28 days) * subjects who are currently taking antidepressants or other psychotropic medication. * subjects who have initiated psychotherapy during the three months prior to randomization. * subjects with a positive urine drug screen. * subjects who have a history of poor response or intolerance to methylphenidate or d-methylphenidate. other protocol-defined inclusion/exclusion criteria may apply

Keywords: adhd, children, subjects, laboratory classroom
resting-state functional mri in glioma patients before and after surgery

Conditions: Brain Mass; Glioma

Summary: this clinical trial studies how well resting-state functional magnetic resonance imaging (mri) and cerebrovascular reactivity (cvr) mri performed before and after surgery works in measuring the effects on language in patients with glioma. mapping language function before brain tumor resection is crucial for preventing post-surgical deficits and maximizing restoration of language function following surgery. additional imaging, such as resting-state functional mri and cvr mri, may help measure the language network in the brain before surgery and any effects on language function after surgery.

primary objectives: i. to develop a reliable platform for preoperative mapping of language networks using resting-state-functional magnetic resonance imaging (rs)-fmri in glioma patients. secondary objectives: i. to explore the reorganizations of resting-state functional connectivity (fc) and their relation to neuropsychological outcomes in glioma patients after surgery. outline: patients undergo standard of care functional (f)mri, cvr mri over 3 minutes, and rs-fmri over 6 minutes 1 month before and within 6 weeks after standard of care surgery. after completion of study, patients are followed up at 4-6 weeks.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed brain mass suspected to be gliomas * english speaker * right handed * tumor is located on or adjacent to broca's or wernicke's areas in the hemisphere suspected to be dominant for language * no prior history of neurologic disease or insult, or neuropsychiatric illness requiring treatment that would affect cognition in the opinion of the attending neuropsychologist * patients who will undergo neurosurgical resection * patients who are on neurosurgical evaluation will undergo direct cortical stimulation (dcs) as standard of care * patients who will complete pre- and postoperative neuropsychological testing per standard of care * pregnant women exclusion criteria: * patients with prior radiation or chemotherapy * patients cannot give informed consent * patients cannot undergo mri and functional mri examinations
trainee involvement in ercp risk score

Conditions: Bile Duct Diseases; Pancreas Cancer

Summary: the study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ercp) conducted in a teaching setting, with trainee involvement.

the study aims to evaluate factors associated with an increased risk of procedure related adverse events (including tecnical failure) of endoscopic retrograde cholangiopancreatography procedures (ercp) conducted in a teaching setting, with trainee involvement. it has previously shown that ercp procedures with trainee involvement have no additional risk for the patient, but we aim to evaluate whether a subgroup of high-risk procedures can be identified to allow an improvement of the teaching of ercp, including identifying some high risk features that might indicate that trainee involvement should not be warranted. briefly, the study is observational in nature and aims to gather clinical data about the patient and technical data about the procedure (including the degree of trainee involvement( to assess which (if any) procedures carry a higher risk for the patient in a training setting. data will be gathered using a standard report form completed by the attending endoscopist at the end of each procedure; the form will then be updated at 30days interval with data about potential adverse events. patient identity will be protected throughout the study as per regulations in each institution and country; also all patients will sign an informed consent prior to the endoscopic procedure and study enrollment.

Eligibility criteria:
inclusion criteria: * patients undergoing ercp in the participating centers * informed consent signed prior to the procedure exclusion criteria: * refusal to participate / sign the informed consent
efficacy and safety of tenalisib in patients with metastatic triple negative breast cancer (tnbc)

Conditions: Triple Negative Breast Cancer (TNBC)

Summary: this is a phase ii, open-label, single-arm, study, designed to evaluate the efficacy and safety of tenalisib in patients with metastatic tnbc, who have received at least one but not more than 3 prior therapies in a metastatic setting.


Eligibility criteria:
inclusion criteria: 1. patients who have histologically confirmed tnbc. 2. patients who have received at least 1 but not more than 3 prior chemotherapy regimens in a metastatic setting. 3. patients with at least one measurable lesion, per recist version 1.1 at baseline . bone-only disease is not permitted. 4. ecog performance status 0 to 2. 5. adequate bone marrow, liver, and renal function exclusion criteria: 1. cancer therapy/ any cancer investigational drug within 3 weeks (21 days) or 5 half-lives (whichever is shorter). 2. patient who has not recovered from acute toxicities of previous therapy except treatment-related alopecia. 3. prior exposure to pi3k inhibitors (e.g., alpelisib, buparlisib) for breast cancer. 4. major surgery within 4 weeks of starting study treatment. 5. patient with symptomatic uncontrolled brain metastasis. 6. ongoing immunosuppressive therapy including systemic corticosteroids. 7. history of severe cutaneous reactions. 8. concurrent disease or condition that would interfere with study participation 9. pregnancy or lactation. 10. any severe and/or uncontrolled medical conditions or other conditions that could affect patient participation

Keywords: rp6530 tenalisib
multi-center study of residual neuromuscular block incidence in the post-anesthesia care unit

Conditions: Incomplete Reversal of Neuromuscular Block; Postoperative Respiratory Complications

Summary: residual neuromuscular block (rnmb) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. the incidence is variable due to multiple factors. in spain the incidence is unknown. the investigators hypothesize that a number of patients in the postanesthesia care unit (pacu) present with rnmb after general anesthesia using intermediate action neuromuscular block agents (nmba). the main objective is to know the incidence of rnmb in spanish hospitals. secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.

residual neuromuscular block (rnmb) is frequent in the immediate postoperative period and is a source of complications, mainly respiratory. this includes recovery delay or hospital discharge delays, respiratory insufficiency or infections, unforeseen icu admissions, and prolonged icu stays. the incidence is variable due to multiple factors. age, gender, surgery, nmba type and doses, temperature, medications, etc. in several studies it has been found and incidence between 6-80%. few studies have been focused in evaluating the incidence in the whole country, as representing a global anesthesia practice. in spain the incidence is unknown. the investigators hypothesize that a number of patients in the postanesthesia care unit (pacu) present with rnmb after general anesthesia using intermediate action nmba. the main objective is to know the incidence of rnmb in spanish hospitals, by means of an observational cross-sectional multicenter study . secondary objectives are to observe the possible relationship with other pre- and intraoperative factors.

Eligibility criteria:
inclusion criteria: * patients \>18 years-old * general anesthesia with non-depolarizing nmba * transferred extubated on spontaneous ventilation to the pacu exclusion criteria: * american society of anesthesiologists physical status iv-v * emergency and cardiac surgery * patients unable to respond adequately at the moment of pre- or postoperative evaluation (psychiatric diseases, excessive somnolence, agitation, etc.) * noncompensated diabetes mellitus or diabetic neuropathy * symptomatic severe hypothyroidism (or untreated), or scheduled for total thyroidectomy * chronic or acute renal insufficiency * severe hepatopathy (child-pugh b, c) * intraoperative blood transfusion \>3 blood units * intraoperative maintained arterial hypotension * arrival to the pacu intubated or with instrumented airway (including surgical) * pre- or perioperative drugs intake affecting the neuromuscular transmission * neuromuscular diseases affecting the physiology of the neuromuscular system

Keywords: muscle relaxants postoperative complications, respiratory general anesthesia postanesthesia care unit neuromuscular block reversal
early patient access single named patient program for the use of ulocuplumab for the treatment of multiple myeloma

Conditions: Multiple Myeloma in Relapse; Multiple Myeloma

Summary: participant that has been diagnosed with relapsed/ refractory multiple myeloma and are currently participating in a clinical trial which is closing. this research study is studying ulocuplumab as a possible treatment. it's an expanded access from nct01359657

this research study is an expanded access trial, which is a way to provide an investigational therapy to individuals who are not eligible to receive that therapy in a clinical trial, but have a serious or life-threatening illness for which other treatments are not available. the purpose of this expanded access program is to treat participants diagnosed with relapsed or refractory multiple myeloma with an investigational drug called ulocuplumab. participants enrolled in the program will receive ulocuplumab with lenalidomide and dexamethasone or ulocuplumab with bortezomib and dexamethasone. ulocuplumab is supposed to kill myeloma cells. lenalidomide, which is also known as revlimid® and bortezomib, which is also known as velcade®, are approved by the fda for treatment of multiple myeloma. dexamethasone, also known as decadron®, is also approved by the fda for other treatments. it is a type of steroid medication that fights inflammation.

Eligibility criteria:
inclusion criteria: * signed informed consent document * must be currently participating on protocol 11-240 (dfci)/ ca 212-002(bms), tolerating therapy, and still receiving benefit from treatment. exclusion criteria: * prior exposure to ulocuplumab other than in dfci protocol 11-240 (bms protocol ca212-002) or any other any other cxcr4 inhibitor (small molecule within 14 days; antibody against cxcr4 within 10 weeks).

Keywords: multiple myeloma relapsed multiple myeloma refractory multiple myeloma
the ctdna for evaluating whether to use adjuvant therapy after sbrt in patients with early lung cancer

Conditions: Stereotactic Body Radiation Therapy

Summary: the purpose of this study is to determine whether ctdna could help to evaluate whether to use drug adjuvant therapy after sbrt in patients with early lung cancer.

this is a prospective study. the purpose of this study is to determine whether mrd could help to evaluate whether to use drug adjuvant therapy after sbrt in patients with early lung cancer. the ctdna was detected for early stage lung cancer patients before and after sbrt. if a high level of ctdna was detected after sbrt, the patients were randomly divided into observation group and adjuvant treatment group.

Eligibility criteria:
inclusion criteria: 1. patients pathologically diagnosed as non-small cell lung cancer, and was early stage（ajcc 8th）; 2. patients aged between 18 -80 years; with expected survival time\>3 months. 3. patients with normal organ function within 30 days prior to treatment, the following criteria are met: 1. blood routine examination criteria : i) hemoglobin (hb) ≥90g/l; ii) absolute neutrophil count (anc) ≥1.5×10e9/l; iii) platelet (plt) ≥80×10e9/l; b) biochemical tests meet the following criteria: i) total bilirubin (tbil) ≤1.5 times of upper limit of normal (uln); ii) alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2.5 uln; iii) serum creatinine (cr) ≤1.5 uln or creatinine clearance (ccr) ≥60ml/min; exclusion criteria: 1. patients with small cell lung cancer (including small cell carcinoma and non-small cell carcinoma mixed lung cancer); 2. patients with factors that affect oral medication (such as cannot swallow, chronic diarrhea and intestinal obstruction, etc.) or intravenous medication; 3. patients with any other severe and/or uncontrolled disease; 4. patients with a history of psychotropic medicine abuse and cannot quit or have mental disorders; 5. patients with disease which will severely endanger their security and could not complete this study, according to the judgement of researchers；
treatment patterns and clinical outcomes among patients receiving palbociclib combinations for hormone receptor positive (hr+)/human epidermal growth factor receptor 2 negative (her2 ) advanced/metastatic breast cancer in the arabian gulf region

Conditions: Breast Neoplasms

Summary: retrospective non-interventional study (nis) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of hr+/her2- metastatic/locally advanced breast cancer (bc)


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old. 2. hr+/her2- bc diagnosis with confirmed metastatic/locally advanced disease. 3. patient initiated on palbociclib (regardless the line of therapy) within the period between 01st january 2015 and 01st march 2019. 4. minimum of six months of follow up data since palbociclib initiation. 5. received palbociclib plus aromatase inhibitor or palbociclib plus fulvestrant in line with the licensed indication(s). exclusion criteria: 1. prior or current enrolment in an interventional clinical trial for metastatic/locally advanced bc. 2. patients who were initiated on palbociclib after 01st march 2019.

Keywords: retrospective studies palbociclib
evaluation of onefit scleral lenses in the mangement of dry eye

Conditions: Dry Eye

Summary: this study is being conducted to determine if scleral lenses coated with hydra-ped improve comfort and dryness.

the objective of the study is to determine if scleral lenses with and scleral lenses without hydra-peg coating provide positive improvement in ocular comfort and dryness scores. the effect of the study lenses and the coating, will be compared in a group of symptomatic soft lens wearers, and also in a group of symptomatic non contact lens wearers. the primary outcome variable for this study is "overall ocular comfort" reported at the screening visit for the habitual vision correction, and at the 4-week follow-up visits for each of the two study lenses. using a 0-10 scale (0.5 steps).

Eligibility criteria:
inclusion criteria: 1. are at least 17 years of age and have full legal capacity to volunteer; 2. have read and signed an information consent letter; 3. are willing and able to follow instructions and maintain the appointment schedule; 4. agree to wear the study scleral lenses for at least 8 hours per day, 5 days a week; 5. have a refraction between +20.00 and -20.00d and spectacle astigmatism of no more than -3.00dc in each eye; 6. have best corrected visual acuity of 20/40 or better in each eye with the study lenses; 7. demonstrate an acceptable fit with the study lenses; 8. have no active ocular disease or inflammation; 9. group 1: habitual wearer of frequent replacement or daily disposable soft lenses; 10. group 2: have not worn contact lenses for 6 months; 11. group 1: contact lens wearers should score ≥12 on cldeq-8; 12. group 2: non contact lens wearers should score ≥13 on osdi. exclusion criteria: 1. are participating in any concurrent clinical or research study, or have done so within the past 30 days; 2. cannot achieve a successful lens fit or vision with the study lens; 3. have been diagnosed with keratoconus or corneal distortion; 4. have any known active\* ocular condition, disease and/or infection; 5. have a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable e.g. pingueculae; 6. are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 7. group 2: non-contact lens wearers who score ≥33 on osdi and also demonstrate either corneal staining ≥3 (oxford scale) or non-invasive tear break-up time ≤3 seconds#; 8. have known sensitivity to the diagnostic sodium fluorescein to be used in the study; 9. are pregnant, lactating or planning a pregnancy\^ at the time of enrolment, by self report; 10. have undergone refractive error surgery; 11. are listed on the delegation log for this study.
a single dose study of lu ag09222 in a headache model with healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to evaluate how well lu ag09222 can prevent blood vessel dilation in a headache model.

this study will investigate the effect of preventive treatment with lu ag09222 on vasodilation, heart rate increase, and headache induced by pacap and vip. subjects will be randomised to three arms, placebo + saline, placebo + vip and pacap, and lu ag09222 + vip and pacap. subjects who complete the study will attend a safety follow-up visit at 10 to 12 weeks after administration of investigational medicinal product.

Eligibility criteria:
inclusion criteria: * the subject has a body mass index (bmi) ≥ 18.0 and ≤ 30.0 kg/m2, and a body weight ≥ 45 and ≤ 95 kg at the screening visit. * the subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an ecg, and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests at screening. exclusion criteria: * the subject fulfils the diagnostic criteria for a primary headache disorder, or has a first degree relative with a primary headache disorder, according to the international headache society (ihs) international classification of headache disorders 3rd edition (ichd-3), except tension-type headache. * the subject has or has had tension-type headache more than once per month on average during the 6 months prior to the screening visit. other inclusion and exclusion criteria may apply.