Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of replication-competent adenovirus 4-vectored vaccine for avian influenza h5n1

Conditions: Bird Flu; Influenza

Summary: the purpose of this study is to compare the safety and immunogenicity over a 9-month period of five different dosages of ad4-h5-vtn in volunteers (vaccinees) who receive three doses of the study vaccine or placebo. in addition, transmission of ad4-h5-vtn will be evaluated in all household contacts residing with the vaccinated volunteers. vaccinees also may participate in a substudy in which they receive a booster vaccination with the licensed influenza virus vaccine, h5n1 (sanofi pasteur).

at least 160 healthy vaccinees will be randomized into 5 ascending dosage cohorts each consisting of at least 32 volunteers. in each dosage cohort vaccinees will be randomly assigned to receive 3 doses of either ad4-h5-vtn or placebo separated by approximately 56 days. volunteers will be followed for 168 days post-third vaccination.

Eligibility criteria:
inclusion criteria: * healthy adults and their healthy adult household contacts. exclusion criteria: * healthcare workers who have direct contact with patients who are immunodeficient, are hiv-positive, have an unstable medical condition, or are under the age of 18. * childcare workers who have direct contact with children 5 years old and younger. * resides with household contacts who are under the age of 18 or over the age of 65. * received or plans to receive licensed inactivated 2009 h1n1 influenza vaccine from 14 days prior to 14 days after any study vaccination. * received or plans to receive any other licensed vaccines from 30 days prior to the first study vaccination until 30 days after the third study vaccination.

Keywords: virus diseases respiratory tract diseases vaccine
mucosal-associated invariant t cells in cases of miscarriage

Conditions: Miscarriage

Summary: miscarriage is the most frequently encountered complication of pregnancy ranging from 10% to 30%. the etiology of recurrent spontaneous miscarriage (rsm) in 40%-50% of cases cannot be identified. immunological disturbances have been suggested to play an important role. previous studies have focused that women with miscarriage have elevated nk cell numbers and activity both in the periphery and in the endometrium. also, nk cells in women with rsm displayed an imbalance of killer cell ig-like receptors (kirs) in favor of activating kir leading to an unbalanced activation of dnk cytotoxicity and higher risk of miscarriage.


Eligibility criteria:
inclusion criteria: * regular marital life with the same partner. * regularly menstruating before current pregnancy. * spontaneous conception. exclusion criteria: * women with polycystic ovarian syndrome or any endocrinal abnormalities like dm, thyroid disorders. * history of abnormal uterine cavity proved by sonohysterography or hysteroscopy before pregnancy. * women with positive consanguinity.
brentuximab vedotin followed by abvd in patients with previously untreated hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg brentuximab vedotin administrations in untreated patients with hodgkin lymphoma (hl).

this is a multicenter pilot phase ii trial assessing 2 administrations of brentuximab vedotin followed by pet scan and subsequent standard treatment with abvd ± radiotherapy. 12 patients defined by inclusion and exclusion criteria will be enrolled in one year. all subjects will be followed for disease evaluation every 3 months for one year after end of therapy until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study. for all study procedures patient will be assigned a unique subject identifier (sid) number that will be used to identify the subject during the screening process and throughout study participation. a master log will be maintained of all consented subjects and will document all screening failures (i.e. subjects who are consented but do not meet study eligibility criteria). study records such as case report forms (crfs) may be maintained electronically and require the same security and confidentiality as paper. clinical information will not be released without written permission of the subject/legal representative, except as specified in the informed consent form

Eligibility criteria:
inclusion criteria: * previously-untreated patients with classical hodgkin lymphoma according to the world health organisation (who) classification * histologically confirmed cd30+ hl * stage ia, iia, iiia * absence of bulky disease * fdg-pet at baseline * eastern cooperative oncology group (ecog) performance status of 0-1 * life expectancy \> 6 months. * age 18-70 years. * patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution. * females of childbearing potential must have a negative pregnancy test result within three days of enrollment. all patients must agree to use effective contraceptive methods (one for male and two for female) during the course of the study and for 6 months following the end of full treatment (brentuximab vedotin + abvd +/- radiotherapy). * written informed consent. * required baseline laboratory data: absolute neutrophil count ≥ 1000/μl platelet count ≥ 50.000/ μl serum bilirubin ≤ 1.5 times uln serum creatinine ≤ 1.5 times uln alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 2.5 times uln exclusion criteria: * peripheral neuropathy \> grade 1 * histologic diagnosis different from hodgkin lymphoma * compressive symptoms * patients previously treated with any anti-cd30 antibody * known human immunodeficiency virus (hiv) positive * known hepatitis b surface antigen-positive, or known or suspected infection active hepatitis c * patients with signs or symptoms of progressive multifocal leukoencephalopathy (pml) * patients with known cerebral/meningeal disease.
phase i/iia study evaluating safety and efficacy of an intratympanic dose of pipe-505 in subjects with hearing loss

Conditions: Sensorineural Hearing Loss

Summary: this is a randomized, double-blind study of pipe-505, or placebo, in subjects with hearing loss associated with speech-in-noise impairment.

this is a randomized-controlled, double-blind study of pipe-505 or placebo given as an injection one time in subjects with sensorineural hearing loss associated with speech-in-noise difficulty. visits to the clinic will occur at baseline, dosing, and days 1, 7, 14, 30, 60 and 90 after treatment. safety will be assessed by periodic measurement of vital signs, ear examination, electrocardiogram (ecg), blood laboratory analyses and occurrence of adverse events (ae). efficacy will be assessed by periodic audiometry and other audiological tests.

Eligibility criteria:
inclusion criteria: * subject's primary language is english. * male or female between 18 and 75 years of age, inclusive, at randomization. * diagnosis of bilateral sensorineural hearing loss (snhl). * normal tympanogram in the ear intended for injection (as defined in protocol) at screening. * male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method during and for 3 months after study drug administration. * the subject is in general good medical health with no clinically significant or relevant abnormalities, including medical history, physical exam, vital signs, ecg, and laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the investigator. exclusion criteria: * history of chronic otitis externa or media, other chronic middle ear disorders, barotrauma, meniere's disease, endolymphatic hydrops, perilymph fistula, herpes zoster oticus or other infectious etiology of hearing loss. * presence of a genetic, syndromal or developmental auditory disorder or of an autoimmune or serious neurological disorder that could contribute to auditory loss. * evidence of current conductive hearing loss, mixed hearing loss or otosclerosis. * history of auditory loss related to exposure to known high-dose ototoxic drugs; any prior exposure to platinum-based medications. * otological disorders that would preclude safe tympanic injection. * presence of a cochlear implant. * evidence of bothersome tinnitus as determined by the investigator. * intratympanic injection within 6 months of randomization. * use of an investigational product or intervention other than a non-interventional registry study (including vaccine studies) within the greater of 30 days or 5 half-lives (if known) prior to screening or expected during the study. * history of malignancy under current active treatment or considered at substantial risk for progression or recurrence during the study interval, as determined by the investigator. note, central nervous system neoplasms or head and neck cancer are excluded from eligibility regardless of treatment status.

Keywords: hearing loss cochlear synaptopathy deafness speech-in-noise hearing difficulty
a study of bempegaldesleukin (nktr-214: bempeg) in combination with nivolumab compared with the investigator's choice of a tyrosine kinase inhibitor (tki) therapy (either sunitinib or cabozantinib monotherapy) for advanced metastatic renal cell carcinoma (rcc)

Conditions: Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma

Summary: the main purpose of this study is to compare the objective response rate (orr) and overall survival (os) of bempegaldesleukin (nktr-214: bempeg) combined with nivolumab to that of tyrosine kinase inhibitor (tki) monotherapy (sunitinib or cabozantinib) in imdc intermediate- or poor-risk patients and imdc all-risk patients with previously untreated advanced renal cell carcinoma (rcc).


Eligibility criteria:
key inclusion criteria: * provide written, informed consent to participate in the study and follow the study procedures * karnofsky performance status (kps) of at least 70% * measurable disease per mrecist 1.1 criteria * histologically confirmed rcc with a clear-cell component (may have sarcomatoid features); advanced (not amenable to curative surgery or radiation therapy) or metastatic (ajcc stage iv) rcc * patients with any international metastatic renal cell carcinoma database consortium (imdc) score (favorable-, intermediate-, or poor-risk) are eligible. at least one imdc prognostic factor must be present to qualify as either intermediate- or poor-risk renal cell carcinoma. * no prior systemic therapy (including neoadjuvant, adjuvant, or vaccine therapy) for rcc key exclusion criteria: * an active, known or suspected autoimmune disease that has required systemic treatment within the past 3 months (exceptions exist) * patients who have a known additional malignancy that is progressing or requires active treatment (exceptions exist) * any tumor invading the wall of a major blood vessels * any tumor invading the gastrointestinal (gi) tract or any evidence of endotracheal or endobronchial tumor within 28 days prior to randomization * need for \>2 medications for management of hypertension (including diuretics) * history of pulmonary embolism, deep vein thrombosis (not including tumor thrombus), or clinically significant thromboembolic event within 3 months of randomization additional protocol defined inclusion/exclusion criteria and exceptions apply

Keywords: kidney cancer kidney neoplasms renal cancer renal neoplasms cd122 cd122-biased agonist cd122-biased cytokine il-2 receptor agonist immuno-oncology therapy nktr-214 nivolumab opdivo® pd-l1 pd-1 bempegaldesleukin il-2 bempeg cd122-preferential il-2 pathway agonist checkpoint inhibition immune checkpoint inhibitor
an observational study of tnkase in patients enrolled in the national registry of myocardial infarction 4 and 5 (post)

Conditions: Acute Myocardial Infarction

Summary: the post study comprised patients whose data were entered into the nrmi 4 and 5 databases. nrmi is a prospective, observational study of patients presenting with ami in the united states. nrmi was launched in 1990 and to date has enrolled more than 2.5 million ami patients. more than 1,700 hospitals have participated in nrmi during the last 16 years. the nrmi 4 and 5 substudies were sponsored by genentech and collected data on approximately 160,000 ami patients (both st elevation and non-st-elevation mi) hospitalized in the united states each year. this corresponds to approximately 18% of the ami patients in the united states.


Eligibility criteria:
inclusion criteria: * presence of lbbb or st-segment elevation (new or of unknown duration) * icd-9-cm discharge code of 410.x1 * treatment with one of the following regimens: tnkase; other thrombolytic regimens; no initial reperfusion exclusion criteria: * patients who were transferred out of the facility * patients with pending data clarification forms on fields related to study variables

Keywords: tnkase ami
low-dose chest ct (ldct) covid-19 study

Conditions: Covid19

Summary: the goal of our proposed pilot study is to collect low dose ct (ldct) findings from chest evaluations of a representative sample of 120 symptomatic caucasian and african american, and hispanic adults (45 each), stratified by presence of acute respiratory distress syndrome (ards) and covid-19 positivity or negative pcr screening results. these data will provide us with preliminary data on the type and extent of alveolar remodeling by race and by severity of recent infectious respiratory disease. findings from our study would will help us to determine if a larger multi-site research application to nhlbi or a similar funding agency might be possible and provide critical preliminary data on variation in ldct findings by covid-19 attributable respiratory health, race, and other risk factors (e.g., smoking history, comorbidities, and socioeconomic status).

this is a prospective data collection study of random samples of caucasian and african american, and hispanic adults, who are symptomatic and recently tested with a nasal or nasopharyngeal swab test (pcr test) and by test positivity and/or evidence of recent acute respiratory distress. our study has 2 objectives: 1) demonstrate the feasibility of using kp electronic health records (ehr) and associated computerized data resources to identify and recruit representative samples of caucasian and african american, and hispanic adults with varying likelihoods of lung remodeling, and 2) identify the implementation opportunities and challenges associated with recruitment for and collection of primary ldct findings in a representative sample of adults from a diverse urban population. the specific aims of our study are: aim 1: implement a sampling and recruitment protocol to collect representative samples of caucasian and african american, and hispanic adults by clinical history attributable to ards (e.g., hospitalization for ards, not hospitalized by positive/negative for covid-19) and presenting with symptoms typical of covid-19 (i.e. fever, cough, shortness of breath, nausea/vomiting) aim 2: collect ldct findings and self-reported respiratory health at the time of ldct from this sample. aim 3: link the ldct findings to other electronic health record (ehr) data to assess face validity of findings through associations with race, other patient demographics, and clinical risk factors associated with self-reported respiratory health.

Eligibility criteria:
inclusion criteria: * kpmas members, primarily residing in the dcsm service area (montgomery, frederick or prince george's counties), * ≥ 18 years of age or older * have a recent pcr test with a positive or negative result, and/or evidence of ards and who were symptomatic for covid-19 related symptoms at the time of the test. exclusion criteria: * pregnant or intending to become pregnant in the next 1-3 months * cancer or other treatment involving radiation therapy at any time * terminally ill * non-english speaking * diminished cognitive capacity * developmental disabilities
bioenergetic alterations after exenatide administration

Conditions: Healthy

Summary: the purpose of this study is to find out how exenatide causes weight loss. specifically, the study is assessing how exenatide may change how people take in energy (energy intake), as well as how it may effect how people use energy (energy expenditure).

the bioenergetics study is looking at how and why the diabetes drug exenatide causes people to lose weight.bioenergetics is the study of how your body burns calories. adults 18-65 who do not have diabetes and have a body mass index (bmi) between 30 and 40 may be eligible. women who could get pregnant must be on birth control during the study and women who are pregnant cannot participate in the study. subjects will take exenatide for 12 weeks. there are 6 study visits in the univ. wisconsin hospital general clinical research center. visits range from 1 to 6 hours and include blood and urine tests, resting metabolic rate testing over a four hour period, physical exam, ecg, and a be bone mineral density testing at another clinic during 2 clinic visits of the study. all study procedures and testing are free of charge.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * bmi between 30 and 40 kg/m2 * women with a negative pregnancy test at baseline, who are sterile, using contraceptives or in a committed relationship with someone who is sterile or using contraception * absence of weight change greater than 3 kg in the previous 6 months exclusion criteria: * women who are pregnant or lactating * current or recent (6 months) enrollment in a commercial or self prescribed weight loss or exercise program * use of weight loss medication * a history of metabolic disease i.e. renal, endocrine, hepatic or gastrointestinal disease that would impact the outcome of the study * presence of medical conditions that are known to affect energy expenditure (i.e. hyperthyroidism, rheumatoid arthritis, aids among others) * history of hypoglycemia * a history of psychiatric or eating disorder * abnormal ekg * previous history of pancreatitis * previous history of gastroparesis or gi motility disorder * use of medications that can affect gi motility * history of organ transplantation * other comorbid conditions which may preclude the subject's ability to complete the study * use of a carbonic anhydrase inhibitor such as acetazolamide

Keywords: exenatide byetta weight loss energy expenditure normal volunteers
the efficacy and safety study of sulodexide in filipino diabetic patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to determine the effect and safety of sulodexide in filipino patients with chronic kidney disease (ckd).


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * positive 2 of 3 acr \> 300 mg/g or 24h urine protein or albumin collection \> 300 mg/d in the absence of urinary tract infection * serum creatinine 1.3 - 3 mg/dl in women and 1.5 - 3 mg/dl in men exclusion criteria: * age of onset of dm \\\< 18 years * + renal disease like non-dm renal disease * + cv diseases such as ua, mi, cabg * + cva or tia within last 6 months * untreated uti

Keywords: diabetes mellitus chronic kidney disease glycosaminoglycans sulodexide macroalbuminuria safety and efficacy
efficacy of gevokizumab in the treatment of patients with behçet's disease uveitis (eyeguard™-b)

Conditions: Behcet's Uveitis

Summary: the objective of this study is to demonstrate the superiority of gevokizumab as compared to placebo on top of current standard of care in reducing the risk of behçet's disease uveitis exacerbations

a randomized, double-masked, placebo-controlled study of the efficacy of gevokizumab in the treatment of patients with behçet's disease uveitis

Eligibility criteria:
inclusion criteria: * behçet's disease diagnosis fulfilling the international study group classification criteria. * history of behçet's disease uveitis with ocular involvement of the posterior segment. * patients with a stable background treatment of oral corticosteroid and at least one immunosuppressive drug. * male or female, age ≥18 (or legal age of majority in the country) at selection * for subjects with reproductive potential, a willingness to use highly effective contraceptive measures exclusion criteria: * infectious uveitis, uveitis due to causes other than behçet's disease. * monocular vision * presence of severe cataract or severe posterior capsular opacification. * contraindication to mydriasis or presence of posterior synechiae. * active tb disease. * history of severe allergic or anaphylactic reactions to monoclonal antibodies * history of malignancy within 5 years prior to selection. other protocol-defined inclusion/exclusion criteria may apply
effect of platelet-rich fibrin on rotator cuff repair

Conditions: Rotator Cuff Tears of the Shoulder

Summary: the objective of this study was to prospectively evaluate the influence of local application of platelet rich fibrin (prf) on the functional outcome and integrity of the arthroscopically repaired tendons in patients with massive tears of the rotator cuff.

a prospective, randomized clinical trial was performed on 28 patients (22 females, 6 males) with an average age of 65 years (range, 53 to 77) undergoing complete arthroscopic repair of a massive rotator cuff tear. in 14 patients, after the repair was completed, 6 cc. of prf (vivostat ®) were locally applied to the repair site. in 14 patients no addition of prf was performed. all patients underwent an arthro-mri to evaluate the integrity of the repair and a clinical exam one year after the operation. all patients were then followed clinically at a minimum of 2 years. functional outcome was evaluated with the constant and dash scores.

Eligibility criteria:
inclusion criteria: * massive rotator cuff tears affecting supraspinatus and infraspinatus * failed conservative treatment for at least 6 months * no hematologic disorder exclusion criteria: * rotator cuff affecting subscapularis * chronic infectious disease * anemia * clot disorders * low platelet count * history of difficulty in venous puncture

Keywords: rotator cuff shoulder platelet rich plasma fibrin