Kornimate/medical-research-clean huggingface dataset:
awake proning in covid-19 patients with hypoxemic respiratory failure

Conditions: Oxygen Deficiency; Coronavirus Infection

Summary: the purpose of this study is to retrospectively review clinical data to determine whether awake proning improves oxygenation in spontaneously breathing patients with covid-19 severe hypoxemic respiratory failure.

critically ill patients with coronavirus disease 2019 (covid-19) severely strained intensive care resources in new york in april 2020. the prone position improves oxygenation in intubated patients with acute respiratory distress syndrome. the investigators wanted to study whether the prone position is associated with improved oxygenation and decreased risk for intubation in spontaneously breathing patients with severe covid-19 hypoxemic respiratory failure. awake prone positioning was implemented based on the health care provider decision.

Eligibility criteria:
inclusion criteria: * consecutive patients admitted to the columbia university step-down unit from april 6, 2020. * laboratory confirmed covid-19 infection with severe hypoxemic respiratory failure defined as respiratory rate ≥30 breaths/min and oxyhemoglobin saturation (spo2) ≤93% while receiving supplemental oxygen 6 l/min via nasal cannula and 15 l/min via non-rebreather facemask. exclusion criteria: * altered mental status with inability to turn in bed without assistance * extreme respiratory distress requiring immediate intubation, or oxygen requirements less than specified in the inclusion criteria.

Keywords: awake proning covid-19 sars-cov-2
efficacy of exercise program for facedown posture-related pain after retinal surgery

Conditions: Macular Holes; Retinal Detachment

Summary: the purpose of this study is to evaluate the effects of a structured exercise program on musculoskeletal pain of patients in face-down posture after retinal surgery.

after being informed about the study, patients who are planning to get vitrectomy for macular hole or retinal detachment are going to be randomly assigned into two groups; exercise group and control group. all patients are going be admitted to the hospital prior to the surgery. after the surgery is done, the patients are going to maintain a face-down position in the ward until postoperative day 3. after returning to the ward after surgery and completed the pain scoring forms, exercise training is going to be conducted for patients assigned to the exercise group by a physical therapist. three times of daily self-exercise sessions are going to be performed according to the training provided to the patients. pain score will be measured on the first, second and the third postoperative days. patients will be discharged on the third postoperative days.

Eligibility criteria:
inclusion criteria: * patients who are getting vitrectomy for macular hole or retinal detachment and planning to maintain face-down posture. exclusion criteria: * pre-existing musculoskeletal disorder. * low visiual acuity in the opposite eye (best-corrected visual acuity less than 20/200 by snellen chart) making patients hard to get the exercise training. * patients with posture prescriptions other than the prone position

Keywords: face-down posture musculoskeletal pain vitrectomy
efficacy of losartan + amlodipine compared to amlodipine alone in the treatment of uncontrolled high blood pressure (mk-0954f-399)

Conditions: Hypertension

Summary: this study will determine whether using losartan and amlodipine together will be non-inferior in lowering blood pressure than amlodipine alone.


Eligibility criteria:
inclusion criteria * participants with essential hypertension: * who are on single drug therapy * who are newly diagnosed and not yet taking any drug therapy, or have not had any drug therapy for at least 2 weeks prior to entering study * who have blood pressure readings of 90mmhg ≤ msdbp \< 110mmhg and 140mmhg ≤ mssbp \<180mmhg after 2 weeks wash-out for patients on single agent. * randomization (visit 3) * after dosing of amlodipine 5mg for 6 weeks, blood pressure readings are: * 90mmhg ≤ msdbp \< 110mmhg and 140mmhg ≤ mssbp \< 180mmhg. exclusion criteria * participant with msdbp ≥ 110mmhg or mssbp ≥ 180mmhg. * participant currently taking ≥ 2 antihypertensive medications (note: fixed-dose combination medicine should be counted as the number of active ingredients). * participant with known secondary hypertension of any etiology. * participant with malignant hypertension or current evidence of impending or active malignant hypertension, including headache, papilledema, cardiac ischemia, or pulmonary congestion precipitated by elevated blood pressure. * participant with known intolerance, contraindication or hypersensitivity to any component of dihydropyridines, angiotensin ii receptor blockers. * participant showing positive in pregnancy test, lactating woman, or woman who intends to get pregnant during the study period.

Keywords: hypertension uncontrolled hypertension high blood pressure uncontrolled high blood pressure untreated high blood pressure untreated hypertension essential hypertension
perioperative mfolfox-6 in locally advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: this is a phase ii trial of perioperative chemotherapy with oxaliplatin, 5-fluorouracil, leucovorin(modified folfox6)in patients with locally advanced operable gastric cancer.

the main purpose of this study is to evaluate response rate (clinical response and pathological response) of oxaliplatin, 5-fluorouracil, leucovorin(modified folfox6)

Eligibility criteria:
inclusion criteria: * previously untreated patients with pathologically proven advanced gastric adenocarcinoma with regional ln metastasis are eligible for this study (clinical stage: ct2-4 and n+). at least one measurable regional lymph node metastasis according to the response evaluation criteria in solid tumors (recist v. 1.0) \[17\] is required. other eligibility criteria include age between 18 and 75 years, eastern cooperative oncology group performance status (ecog ps) of 0 or 1, no prior chemotherapy or radiotherapy, and adequate bone marrow, hepatic and renal function (absolute neutrophil count \[anc\] ≥ 1.5ⅹ109/l, platelet count ≥ 100ⅹ109/l, total bilirubin ≤ 1.5ⅹupper limit of normal \[uln\], serum transaminases ≤ 2.5ⅹuln, alkaline phosphatase ≤ 2.5ⅹuln, serum creatinine ≤ 1.5ⅹuln or actual or calculated creatinine clearance ≥ 50 ml/min). exclusion criteria: * exclusion criteria include clinical stage t1 tumors, clinical or radiologic evidence of distant metastasis, intestinal obstruction or impending obstruction, active tumor bleeding, interstitial pneumonitis or symptomatic pulmonary fibrosis, peripheral neuropathy of national cancer institute common toxicity criteria (nci-ctc) grade ≥1, pregnant or breastfeeding patients, and other serious diseases.
optimal endotracheal cuff pressure during hospitalization in intensive care units using anapnoguard 100 system

Conditions: Ventilator Associated Pneumonia

Summary: hospitech respiration ltd has developed the anapnoguard system, an innovative system intended to enhance optimal endotracheal tube (ett) cuff inflation, by monitoring carbon dioxide (co2) in upper airways of mechanically ventilated patients. optimal ett cuff inflation will lead to a reduction of complication rate related to mechanical ventilation procedure. this study was design in order to evaluate the feasibility of using the anapnoguard system.


Eligibility criteria:
inclusion criteria: * age above 18 (men and woman); * patient is admitted to icu and expected to receive mechanical ventilation for at least 48 hours; * normal chest x-ray; * connection of the ett to the anapnoguard system less than 6 hours from intubation initiation; * signed informed consent by subject's legally acceptable representative. exclusion criteria: * patients who had been treated with mechanical ventilation during the last year; * fever from known chest/lung origin; * patients with facial, oropharyngeal or neck trauma; * bmi\>35; * height \< 1.6 m; * any chest x-ray pathology during the first 24 hours post intubation; * more than 7 days hospitalization prior to the intubation. chest/lung infection.

Keywords: vap
study of genetic risk factors for spina bifida and anencephaly

Conditions: Spina Bifida; Anencephaly

Summary: the purpose of this study is to describe the genetic contribution to the neural tube defects spina bifida (sb) and anencephaly (a), which includes identifying patients, defining the roles of certain genes, and studying gene-environment interactions.

the terms spina bifida and anencephaly include a range of developmental malformations that result from abnormal or incomplete closure of the neural tube. despite advances in treatment and prenatal detection, these conditions remain as one of the most common and serious groups of birth defects. spina bifida is associated with both increased mortality and morbidity, and anencephaly is always fatal. the occurrence of these conditions has a profound influence on affected individuals and their families and important public health implications. the etiology of ntds has been of considerable interest for several decades. they are known to be etiologically heterogeneous and to occur in association with chromosome abnormalities, teratogenic exposures, and occasionally as part of single gene disorders. however, a specific causative agent cannot be identified in the vast majority of affected individuals. the etiology of ntds in these "non-syndromic" patients is believed to be complex and to involve both genetic and environmental risk factors. using a comprehensive research program, this study will evaluate the potential genetic determinants of sb and anencephaly in a large, well-characterized sample. the family constellation used in this study consists of the proband (individual with an ntd - sb or a) and the proband's biologic parents and maternal grandparents. blood or saliva samples are obtained from individuals and their families. genomic dna from all study participants is prepared from the samples, and genetic loci are evaluated. the proband, or his/her parents, complete a study questionnaire to obtain family history and epidemiologic information.

Eligibility criteria:
inclusion criteria: * families that include at least 1 member who has sb or who had a fetus affected with sb or anencephaly exclusion criteria: * have an ntd (sb or anencephaly) as a component of an identified syndrome * families of individuals who have diagnoses other than sb or anencephaly

Keywords: genetic predisposition to disease environmental exposure chromosome mapping data collection
a multicenter, observational, single arm study of the tecnis presbyopia-correcting intraocular lens

Conditions: Cataracts

Summary: ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the tecnis pc iol.


Eligibility criteria:
inclusion criteria: * patients who are bilaterally implanted with tecnis pc iol and are at least 45 days postoperative from their second eye surgery * clear intraocular media * signed informed consent and data protection documentation * availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures * ability to understand, read, and write english or the local language in which the informed consent and questionnaires are provided exclusion criteria: * subjects with ongoing adverse events that might impact outcomes during the study * use of systemic or ocular medication that may affect vision * acute or chronic disease or condition, ocular trauma or surgery that may confound results * patients with amblyopia, strabismus, nystagmus * concurrent participation in another clinical trial
massive iron deposit assessment

Conditions: Iron Overload; Excessive Body Iron Burden

Summary: iron overload is a severe complication of multiple blood transfusions. as the body has no physiologic mechanism for clearing iron, repeated transfusions cause iron accumulation in organs and lead to iron toxicity. accurate assessment of iron overload is paramount to quantify excessive iron accumulation and to monitor response to iron chelation therapy. magnetic resonance imaging (mri) methods have been used to noninvasively measure hepatic iron concentration (hic). although mri-based measurements of transverse relaxation rates (r2 and r2\*) accurately predict biopsy-proven hics below 15 mg fe/g, previous studies have shown that their precision is limited for hics above 15 mg fe/g and inaccurate above 25 mg fe/g. current r2\* gradient-echo (gre) mr techniques fail occasionally for very high iron overloads (hic \~ 15-25 mg fe/g) and always for massive iron overloads (hic \> 25 mg fe/g) because r2\* is so high that the mr signal decays before it can be measured accurately. overall accrual: 200 patients purpose: to determine if a new mri (ute) can measure the amount of iron in the liver of people with large amounts of iron and compare the results with the same patient's liver bx. estimated patient accrual is 150. it is estimated that 41 of these patients will have clinical indication for liver biopsy.

the midas study is a prospective and non-therapeutic study that will test a new mri technique for the assessment of iron overload in the liver: the newly developed ultra short echo time (ute), r2\*-ute. the r2\*-ute technique, developed by st. jude investigators from the department of radiological sciences, will be first tested in healthy volunteers for feasibility and implementation of the technique. the technique will then be tested in research participants, who will have both the r2\*-gre and the r2\*-ute techniques performed, in addition to a liver biopsy for liver iron quantitation if clinically indicated. quantitation of liver tissue iron will be done at mayo clinic laboratory in rochester, minnesota. primary objective: * to test the association of hepatic iron content (hic) measured with the newly developed 1.5t r2\*-ute technique and hic quantified by liver biopsy in subjects with iron overload. secondary objectives: * to explore the relationship between 1.5t r2\*-ute and 1.5t r2\*-gre measurements in subjects with iron overload. * to explore the relationship between 1.5t r2\*-ute measurements with iron studies (serum iron and transferrin saturation) in subjects with iron.

Eligibility criteria:
inclusion criteria * history of 12 or more lifetime erythrocyte transfusions, and * need for liver iron content assessment (by mri or liver biopsy) exclusion criteria * presence of certain mr-unsafe foreign material in the body, or other conditions that make the research participant ineligible for an mri scan per st. jude policies. * any condition or chronic illness that in the opinion of the pis makes participation on study ill-advised.

Keywords: sickle cell disease thalassemia hemochromatosis cancer
drug-drug interactions of grazoprevir/elbasvir in taiwan

Conditions: Drug Interaction Potentiation

Summary: co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis c (chc) and require drugs to treat and control. grazoprevir/elbavir is metabolized by cytochrome p-450 enzyme of liver. drug-drug interactions (ddis) are important issue before commencing direct acting antiviral agents (daa) treatment for chc patients. few studies from western countries reported that the percentages of ddis of grazoprevir/elbasvir are limited.in asia, real-world analysis of ddis of grazoprevir/elbasvir is lacking and needs to be clarified.

this is a multi-center, retrospective study. five hospitals in taiwan and 400 patients patients treated with grazoprevir/elbasvir during august 2017 to july 2018 are candidates of study subjects. all the required study information will be recorded with detailed chart review. ddi will be evaluated by hep drug interactions (www.hep-druginteractions.org) assessment of comidications: category 0: classification not possible due to lack of information; category 1: no clinical interaction possible; category 2: may require dose adjustment/closer monitoring; category 3: coadministration not recommended or contraindicated. the assessment of ddi will be evaluated and recorded according to the suggested categories, the number of patients at risk for a clinically relevant ddi, and the ratio of patients with at least one predicted ddi between medication of grazoprevir/elbasvir will be calculated.

Eligibility criteria:
inclusion criteria: * patients treated with grazoprevir/elbasvir are candidates of study subjects. exclusion criteria: * none
early postoperative crrt after liver transplantation in aclf patients with overt he

Conditions: Acute-On-Chronic Liver Failure; Hepatic Encephalopathy

Summary: pretransplant hepatoencephalopathy (he) markedly impacts recipient outcomes after liver transplantation. intraoperative crrt showed benefits but feasibility was much concerned. this study aims to observe the effect on consciousness recovery when initiating crrt early in the post-transplant period in recipients with aclf and overt he.

hepatoencephalopathy (he) is a common severe decompensation in end stage liver diseases and resulted to the need of liver transplantation (lt). pretransplant he markedly impacts recipient outcomes after liver transplantation. he in acute on chronic liver failure (aclf) is categorized to type c he. hyperammonemia and systemic inflammation have been reported to contribute its development. continuous renal replacement therapy (crrt) has been shown great benefits in aclf patients with he. intraoperative crrt in lt also showed benefits but feasibility was much concerned. our preliminary retrospective data showed that early crrt (ecrrt) after lt reduced consciousness recovery time, ventilation days and post-transplant infection rate. this open label, parallel randomized trial will observe the effect on consciousness recovery when initiating crrt early (ecrrt) in the post-transplant period in recipients with aclf and overt he. the crrt safety and ventilation days, infection, mortality and icu stay will also be measured.

Eligibility criteria:
inclusion criteria: liver transplant recipients who meet all of the following criteria will be enrolled 1. pre transplant liver failure: total bilirubin over 171μmol/l and prothrombin activity (pta)\<40%; 2. overt hepatic encephalopathy(he): grade ii or higher he according west haven classification; 3. he associated with acute liver failure (type a) or cirrhosis complicated with portal hypertension and/or portal systemic shunts (type c) exclusion criteria: 1. patients with a previous history of kidney-related diseases and glomerular filtration rate \<30 millilitre per minute; 2. patients with acute renal failure need crrt before transplantation; 3. patients newly developed acute renal failure need crrt at the time of randomization; 4. retransplantation or multiple-organs transplantation; 5. any ischemic or hemorrhagic stroke co-morbidity; 6. hemodynamic instability requiring fluid resuscitation or very high dose of vasopressors; 7. extremely moribund patients with an expected life expectancy of less than 24 hours.

Keywords: acute-on-chronic liver failure overt hepatic encephalopathy continuous replacement renal therapy liver transplantation
sodium glycididazole reduces the adverse reactions of concurrent chemoradiotherapy

Conditions: Chemoradiotherapy

Summary: to evaluate the efficacy and toxicity of sodium glycididazole combined with concurrent chemoradiotherapy in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy.

1. to evaluate the efficacy and toxicity of concurrent chemoradiotherapy combined with sodium glycididazole in patients with unresectable locally advanced non-small cell lung cancer after neoadjuvant chemoradiotherapy, and to explore sodium glycididazole as a new way to inhibit the occurrence of radiation esophagitis and reduce the occurrence of radiation pneumonitis and lymphopenia. 2. to evaluate the sensitization effect of sodium glycididazole in the anti-tumor activity during concurrent chemoradiotherapy, as well as the changes in the anti-tumor immune response in peripheral blood, in order to screen out the dominant population and the predictive biomarkers with fewer related toxic and side effects. 3. by exploring the correlation between the expression level of nlrp3 inflammasome activation related molecules and imaging changes in peripheral blood after radiotherapy and the toxicity of radiotherapy and chemotherapy, a risk model for predicting radiation esophagitis after concurrent radiotherapy and chemotherapy for non-small cell lung cancer was further constructed.

Eligibility criteria:
inclusion criteria: 1. patients must have histologically or cytologically confirmed non-small cell lung cancer. 2. patients with unresectable stage ii-iii non-small cell lung cancer after neoadjuvant therapy. 3. ecog ps 0-2 4. adequate organ and bone marrow function. exclusion criteria: 1. history of previous radiotherapy. 2. the previous immune-related pneumonitis ≥ grade 2. 3. local lesions require surgery. 4. history of another primary malignancy. 5. history of active primary immunodeficiency. 6. histological findings showed mixed small cell lung cancer and non-small cell lung cancer. 7. for any unmitigated toxicity during pre-study chemoradiotherapy.
study to determine safety & efficacy of autologous human platelet lysate in androgenetic alopecia after hair transplant

Conditions: Androgenetic Alopecia

Summary: this is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of human platelet lysate (hpl) in subjects with androgenetic alopecia undergoing hair transplantation. the study is being conducted at 2 centers in india. the primary endpoints are increase in hair follicle viability after transplant, improvement in caliber \& density of hair and improvement in photographic assessment from randomization to end of study. the secondary endpoints are physicians and patients self assessment score.


Eligibility criteria:
inclusion criteria: * male subjects, aged between 18 to 50 years (both inclusive) and in general good health * subjects willing to refrain from other aga treatments during the entire study duration * subjects who are willing to give informed consent and adhere to the study protocol exclusion criteria: * subjects aged \ 50 years * subjects with dermatological disorder of scalp that might interfere with study evaluation * subjects on anti-coagulant therapy * subjects with clinically significant medical or psychiatric disease as determined by the investigator. * subjects unwilling to or unable to comply with the study protocol. * subjects taking concomitant therapy that might interfere with the study results in investigators opinion or participating in another trial in the past 30 days.