Kornimate/medical-research-clean huggingface dataset:
convalescent plasma for the treatment of covid-19 (coronavirus disease 2019)

Conditions: Covid19

Summary: this pilot, prospective study will assess the safety and efficacy of covid-19 convalescent plasma versus standard care as treatment for severe and/or critical covid-19 (as defined in the inclusion criteria) in adults 18 years of age and older. a total of 350 eligible subjects will receive a transfusion of anti-sars-cov2 ( severe acute respiratory syndrome) convalescent plasma.

patients meeting inclusion/exclusion criteria will be approached for study consent based on the time of hospital admission and the availability of an blood type compatible product. 300ml plasma units of covid-19 convalescent patients will be utilized for transfusion. during a period of 14 days, the patient will be eligible to receive up to 10 units of plasma, to be completed with 4 hours as per institutional transfusion standard operating procedures. transfusion by apheresis (plasma exchange) may be employed to reduce the risk of volume overload. the number of units to be used will be determined by the study team based on protocol inclusion and exclusion criteria, and clinical evaluation of the patient's severity and response. subjects will be followed for at least 60 days or up to 3 months following initial transfusion for adverse event monitoring and data collection.

Eligibility criteria:
inclusion criteria: recipient must meet criteria outlined in the recent investigational covid-19 convalescent plasma - emergency inds (investigational new drug) guidance (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds) exclusion criteria: 1. history of prior severe reactions to transfusion of blood products with imputability of probable or definite as defined by center of disease control national healthcare safety network hemovigilance module \[see https://www.cdc.gov/nhsn/pdfs/biovigilance/bv-hv-protocol-current.pdf\]. 2. has underlying uncompensated and untreatable end stage disease. 3. fluid overload or other condition that would contraindicate administration of plasma
intravenous compared with intrahepatic chemotherapy in treating patients with colorectal cancer metastatic to the liver

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: randomized phase iii trial to compare the effectiveness of intravenous infusion or intrahepatic infusion of fluorouracil and leucovorin in treating patients with colorectal cancer metastatic to the liver.

objectives: i. compare the survival and response rates of patients with colorectal liver metastases treated with intravenous vs. intrahepatic arterial infusion of fluorouracil/leucovorin. ii. assess the effect of these 2 treatments on symptoms and quality of life of these patients. outline: randomized study. patients randomized to arm ii should have a preoperative hepatic angiography; at laparotomy, an intrahepatic arterial catheter is fused into the gastroduodenal artery to establish an infusion of both lobes of the liver. arm i: single-agent chemotherapy with drug modulation. fluorouracil, 5-fu, nsc-19893; with leucovorin calcium, cf, nsc-3590. intravenous infusion. arm ii: single-agent chemotherapy with drug modulation. 5-fu; with cf. intrahepatic arterial infusion. projected accrual: 312 patients are expected to be randomized within 3-4 years.

Eligibility criteria:
disease characteristics: histologically confirmed adenocarcinoma of the colon or rectum with metastases confined to the liver and not amenable to surgery patient characteristics: age: any age performance status: who 0-2 life expectancy: more than 3 months hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 3.5 mg/dl (50 micromoles/liter) renal: not specified cardiovascular: no uncontrolled heart disease (e.g., congestive heart failure, angina) other: no uncontrolled infection no other uncontrolled medical illness prior concurrent therapy: no prior fluorouracil (5-fu) for advanced disease more than 6 months since adjuvant 5-fu (e.g., in axis or quasar studies)

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer adenocarcinoma of the colon adenocarcinoma of the rectum liver metastases
efficacy of dexamethasone in attenuation of postinduction hypotension in geriatric patients undergoing general anesthesia

Conditions: Hypotension

Summary: * geriatric patients who undergo general anesthesia experience post induction hypotension which is treated with intravenous fluids and ephedrine. the main cause of post-induction hypotension is the decrease in the sympathetic outflow causing arterial vasodilatation, a decrease in venous return and consequently the activation of the bezold jarish reflex (bjr) that elicits a triad of bradycardia, vasodilatation and further hypotension. bjr is elicited by activation of 5-ht3 receptors within the intracardiac vagal nerve endings. * glucocorticoids in general inhibit 5-ht3 expression and dexamethasone was found to decrease the level of 5-ht3 in the cerebral cortex and hippocampus in developing rats. so, the research team hypothesizes that dexamethasone can attenuate the postinduction hypotension in geriatric patients undergoing general anesthesia if administered preoperatively.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists (asa) physical status class-i and ii. 2. elective surgery under general anesthesia. exclusion criteria: 1. emergency surgeries. 2. ischemic heart disease. 3. peptic ulcer \& active infection. 4. psychiatric disorder. 5. patients on steroids or serotonin related medications (e.g., selective serotonin reuptake inhibitor).
efficacy and safety of 3d185 monotherapy in subjects with previously treated locally advanced or metastatic cholangiocarcinoma

Conditions: Cholangiocarcinoma,Adult

Summary: the purpose of this study is evaluate the efficacy of 3d185 in subjects with advanced/metastatic cholangiocarcinoma with fgfr2 gene alterations who have failed at least 1 previous treatment.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed cholangiocarcinoma. 2. documented disease progression following at least one previous systemic cancer therapy 3. tumor assessment for fgf/fgfr gene alteration status. 4. have measurable disease according to recist v1.1 5. ecog performance status ≤ 2 6. life expectancy ≥ 12 weeks. exclusion criteria: 1. previously received selective fgfr inhibitor therapy. 2. history of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications. 3. have any of the following eye diseases/conditions: 1) history of retinal pigment epithelial detachment (rped); 2) history of laser treatment or intraocular injection for macular degeneration; 3) history of dry or wet age-related macular degeneration; 4) history of retinal vein occlusion (rvo); 5) history of retinal degenerative diseases; 6) history of chorioretinal lesions.. 4. received cyp3a4 and/or cyp2c8 strong inhibitors or cyp3a4 strong inducers within 14 days prior to the first dose and subject who need to continue using these drugs.
a long-term efficacy, safety, and tolerability study of botox® in patients with chronic migraine

Conditions: Migraine Disorders

Summary: this open-label study will assess the long-term efficacy, safety, and tolerability of onabotulinumtoxina administered for prophylaxis of headaches in patients with chronic migraine.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) exclusion criteria: * diagnosis of myasthenia gravis, eaton-lambert syndrome, or amyotrophic lateral sclerosis * headache attributed to another disorder * infection or skin disorder at injection sites * previous treatment with botulinum toxin of any serotype for any reason * anticipated need for botulinum toxin of any type for any reason during the course of the study * previous participation in any botulinum toxin clinical trial
pharmacokinetic (pk) and safety study of meropenem in young infants with intra-abdominal infections

Conditions: Necrotizing Enterocolitis; Intra-abdominal Infection

Summary: meropenem is an antibiotic that is commonly used to treat serious infections. although it is used in premature and young infants, the correct dose is not known. the purpose of this study is to determine the correct dose and the safety of meropenem for the treatment of complicated intra-abdominal infections in these young babies.

this study will evaluate the safety, tolerability and pharmacokinetics - pharmacodynamics (pk-pd) of meropenem in infants \<91 days of age with suspected and complicated intra-abdominal infections. the specific aims of this trial are: 1. to characterize meropenem single-dose and multiple-dose pk in subjects with suspected and complicated intra-abdominal infections. 2. to characterize the safety profile of meropenem in the treatment of suspected and complicated intra-abdominal infections. 3. to assess collected efficacy data for meropenem for the treatment of suspected and complicated intra-abdominal infections.

Eligibility criteria:
inclusion criteria: 1. written permission from parent or legal guardian 2. age younger than 91 days 3. likely to survive beyond the first 48 hours after enrollment 4. sufficient intravascular access (either peripheral or central) to receive study drug. and one of the following 5. 1) physical, radiological, and/or bacteriological findings of a complicated intra-abdominal infection. these include peritonitis, nec (necrotizing enterocolitis) grade ii or higher by bell's criteria, hirschsprung's disease with perforation, spontaneous perforation, meconium ileus with perforation, bowel obstruction with perforation, as evidenced by free peritoneal air on abdominal radiograph, intestinal pneumatosis or portal venous gas on abdominal radiographic examination. or 2) possible nec or 3) otherwise receiving meropenem per local standard of care exclusion criteria: 1. renal dysfunction evidenced by urine output \<0.5 ml/hr/kg over the prior 24 hours 2. serum creatinine \>1.7 mg/dl 3. history of clinical seizures or eeg (electroencephalogram) confirmed seizures 4. concomitant treatment with another carbapenem (ertapenem or imipenem) at the time of informed consent 5. any condition which would make the subject or the caregiver, in the opinion of the investigator, unsuitable for the study

Keywords: meropenem infants intra-abdominal infection pharmacokinetics safety
comparison of sonographic and mri weight estimation in fetuses with suspected macrosomia

Conditions: Accuracy of Sonographic Vs MRI Fetal Weight Estimation

Summary: the goal of this clinical trial is to compare the accuracy of sonographic vs. magnetic resonance fetal weight estimation in suspected fetal macrosomia in term pregnancy. pregnant patient at term with suspected macrosomia will participate and undergo both sonographic and magnetic resonance fetal weight estimations and the actual birthweight will be recorded and compared with the fetal weight estimations

the goal of this clinical trial is to compare the accuracy of sonographic vs. magnetic resonance fetal weight estimation in suspected fetal macrosomia in term pregnancy. pregnant patient at term with suspected macrosomia will participate and undergo both sonographic and magnetic resonance fetal weight estimations and the actual birthweight will be recorded and compared with the fetal weight estimations inclusion criteria: singleton pregnancies at term, suspected fetal macrosomia (\>4000 gr in non gdm and \>3800 gr. in gdm cases exclusion criteria-fetal anomaly, pprom, multiple gestation the radiologist and the sonographer will be blinded to the fetal weight estimation and to the other estimation done

Eligibility criteria:
inclusion criteria: singleton pregnancy at term, suspected fetal macrosomia, exclusion criteria: * fetal anomaly multiple pregnancy prom

Keywords: fetal weight estimation, accuracy
regional nerve blocks to improve analgesia and recovery in older adults undergoing spinal fusion

Conditions: Delirium; Pain, Back; Spinal Fusion; Thoracolumbar Interfascial Plane Block

Summary: this initial study is a feasibility study for implementing thoracolumbar interfascial plane, or tlip, blocks in older adults undergoing spinal fusion. tlip blocks are done by using anesthesia. in this case, it will be done to either side of the back where surgery will be performed. this has been shown to decrease pain the patients have post-operatively in previous research. in this study, the investigators will examine recruitment rates, completion of assessments, dropout rate, gather patient feedback, and identify barriers to performing tlip. further, this feasibility study will provide data to determine adequate sample size and refine methods and outcomes for a future randomized clinical trial. the ultimate goal is to perform a large, appropriately powered randomized control trial to determine the effect of tlip blocks on pain, physical function and disability, opioid consumption, and delirium in older adult undergoing spinal fusion.


Eligibility criteria:
inclusion criteria: * are 65 or older * indicated for lumbar spinal fusion of less than or equal to 3 levels * undergoing elective surgery * no contraindications to local anesthetic or procedures * no severe cardiac or respiratory disease * no preexisting cognitive dysfunction/dementia exclusion criteria: * 64 years old and younger * emergency treatment * pathologic fractures * seeking revision surgery * major liver or kidney dysfunction * coexisting hematological disorder or irreversible abnormal coagulation * patients with previous diagnosis of dementia or slums score \<20 * patient unable to communicate/cooperate/language barrier * bmi\>40 * allergy to study medications * opioid tolerant (oral opioid intake morphine equivalent =\< 60 mg/day) * other sources of chronic pain like fibromyalgia * patients with associated significant cns or respiratory disease (home oxygen requirements) * incarcerated patients * psychiatric illnesses preoperative neurological deficits greater than one motor group, less than three out of five motor functions * pregnant or breast feeding
developmental intervention for infants of adolescent mothers

Conditions: Development, Child; Adolescent Behavior; Language Development; Language Delay

Summary: this is a randomized control trial to evaluate a simple language intervention curriculum that utilizes lena recordings, linguistic feedback and text-message review of content to improve language environments and outcomes for infants with adolescent mothers.

mother-infant pairs are enrolled while in the hospital after birth. enrolled participants are randomized into a language (intervention) or motor (control) group. all participants have a baseline lena (device that captures 16 hour recording and associated computer analysis generates a report of numbers of adult words spoken, infant vocalization and conversational turns). interventions after the baseline recording by group are as follows: intervention: 1. review language curriculum and motor curriculum with study personnel 2. direct linguistic feedback of baseline lena recording 3. 2nd lena recording completed and analyzed 4. direct or mailed linguistic feedback of 2nd lena recording 5. 16- weekly text messages 6. 4 month lena recording with mailed linguistic feedback 7. 12 month lena recording with mailed linguistic feedback control: 1. review motor curriculum with study personnel 2. 2nd lena recording completed and analyzed 3. 4- monthly text messages 4. 4 month lena recording 5. 12 month lena recording with mailed linguistic feedback of all recordings both groups undergo the following assessments: 1. ages and stages questionnaire at 4 and 12 months 2. maternal peabody picture vocabulary test at 4 months 3. edinburgh post-partum depression scale at 4 months 4. macarthur bates communicative developmental inventory: words and gestures at 12

Eligibility criteria:
inclusion criteria: * infants ≥30 weeks born to 15-20 year old mothers exclusion criteria: * congenital anomalies associated with adverse developmental outcomes * non-english speaking mothers * no cell phone * mother not available for follow-up * state custody of mother or infant.

Keywords: language lena adolescent
effect of biofeedback on postoperative pain

Conditions: Postoperative Pain

Summary: this study is a multi-center, randomized, controlled, double-blinded, and parallel design study. a total of 106 patients were decided to be recruited considering a 10% dropout rate. patients are randomizes to perform or not respiratory exercises using biofeedback device(rescalm). the randomization numbers are generated using a computer-generated randomization code and are sealed in the opaque envelope until they are handed over to anesthesiologist in charge of patient management. record patient preoperative t anxiety, postoperative pain, and pain medication use. patient aged 19-64 yr, asa class 1 or 2, and are scheduled for elective laparoscopic cholecystectomy are included. patients who were unable to perform self breathing at regular intervals were excluded.

1. assignment of experimental groups group a: respiratory exercise using respiratory biofeedback device(rescalm) is applied 2-3 times / day for 3 minutes until discharge from hospital and once in the recovery room before surgery. group b: general surgery schedule without control exercise. all patients measure stai(state trait anxiety inventory) at the operating room entrance on the day of surgery. 2. anesthesia methods intravenous anesthesia is performed using the target injection concentration control method. as an anesthetic, propofol / remifentanil / rocuronium is used. the artificial ventilation method is a pressure-controlled ventilation method, which maintains an appropriate pressure and performs anesthesia. 3. postoperative care after anesthesia, the patient wakes up and transfers to the recovery room to encourage self-breathing exercise. after entering the recovery room, the patient's vital signs (average blood pressure, heart rate, oxygen saturation) and analgesic use are checked immediately before leaving. the investigators check for the presence of pulmonary complications, visual analog scale (vas), analgesic use, and hospital patient satisfaction for 24 hours after surgery.

Eligibility criteria:
inclusion criteria: * adult patients aged between 19 and 64 years of age with asa class i, ii who underwent regular laparoscopic cholecystectomy under general anesthesia. exclusion criteria: * seniors 65 years of age or older or minors under 19 years of age * asa (american society of anesthesiologists) class ≥ iii * difficulties in proper cooperation with diseases such as alzheimer dementia, cognitive disorders, and psychopathy * patients with respiratory diseases such as asthma, pnuemonia * patients with incomplete airway due to pulmonary resection, airway surgery, mouth or nose surgery

Keywords: respiratory biofeedback postpoerative pain preoperative anxiety
a single, high-dose azithromycin extended release (60 mg/kg) compared with 10 days of high-dose amoxicillin clavulanate in children with ear infections at high risk of persistent/recurrent ear infections

Conditions: Acute Otitis Media

Summary: a phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections


Eligibility criteria:
inclusion criteria: outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included exclusion criteria: patients with previously diagnosed disease of immune function, treatment with any systemic antibiotic within the previous 7 days, or cleft lip/palate or other anatomic abnormality predisposing to otitis media were excluded.
a study on patients with chronic kidney disease (ckd) to assess treatment experience and patterns, effect of the treatment, patient outcomes and patient quality of life

Conditions: Chronic Kidney Disease

Summary: discover ckd is an international observational cohort study in patients with ckd, comprising both prospective and retrospective patient cohorts. the study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care.

discover ckd is an international observational cohort study in ckd patients, comprising both prospective and retrospective patient cohorts. the study does not attempt to test any specific a priori hypotheses, is largely descriptive, and utilises data collected only under conditions of routine clinical care. no additional invasive clinical tests or procedures are mandated per study protocol, and all data collected/extracted is based solely on observations of disease management and treatment decisions made between the treating physicians and their patients, and is not intended to be interventional in anyway. patients will not receive any experimental intervention or experimental treatment as a result of participating in this study. analyses will be conducted separately for prospective and retrospective ckd cohorts (via interim reports), and then in aggregate by combining prospective and retrospective data, to the extent possible, at the end of the study.

Eligibility criteria:
inclusion criteria: 1. for all countries, except japan: male or female patients aged 18 years and over. for japan: male or female patients aged 20 years and over. 2. first documented diagnostic code (eg, international classification of diseases-10) of ckd (stages 3a, 3b, 4, 5, or end stage renal disease) or two measures of egfr of \<75ml/min/1.73 m\^2 recorded at least 90 days apart on or after 1 january 2008, or a code for chronic renal replacement therapy (hemodialysis and peritoneal dialysis), whichever comes first. 3. provision of written informed consent - specific for prospective data capture. exclusion criteria: 1. concurrent participation in any interventional trial at baseline (index) (prospective only). to be implemented based on local regulatory requirements. 2. the patient is undergoing treatment for active cancer, except for non-melanoma skin cancer. 3. patients with a life expectancy of less than 12 months (prospective only). 4. diagnosis of cancer on or within the 1-year prior to index (retrospective only). 5. less than 1-year registration/medical history (pre-index) (retrospective only).

Keywords: observational study real-world data prospective and retrospective data capture discover ckd