Kornimate/medical-research-clean huggingface dataset:
improving right ventricular function in young adults born preterm

Conditions: Infant,Premature

Summary: the purpose of this research is to evaluate the short-term effects of sildenafil and metoprolol on heart function in young adults born premature.

the purpose of this study is to evaluate the short-term therapeutic effects of sildenafil and metoprolol on right ventricular function in young adults born premature using novel 4-dimensional flow cardiac magnetic resonance imaging.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. male or female aged 18-35 3. history of preterm birth (either a or b): 1. participant in the newborn lung project (birth year 1988-1991, birth weight \<1500 g) 2. non-nlp participant, with birth weight \<1500 g and gestational age 32 weeks or less, verified by medical records exclusion criteria: 1. pregnant or lactating 2. use of prescribed medications that would interfere with study medications 1. sildenafil: use of phosphodiesterase type 5 inhibitors (sildenafil, tadalafil, vardenafil), nitrates, soluble guanylate cyclase inhibitor (riociguat) within 48 hours of study visit 2. metoprolol: use of nodal blocking agents including beta blockers, non-dihydropyridine calcium channel blockers (i.e. diltiazem), and anti-arrhythmics (i.e. amiodarone) 3. presence of known comorbidities for which these therapeutic interventions would be contraindicated: 1. moderate to severe heart failure 2. severe bradycardia (heart rate \<45), or second or third-degree heart block 3. systolic blood pressure \ 190 mmhg 4. angina 5. severe peripheral arterial circulatory disorders 6. history of severe bronchospasm 4. presence of any implanted device incompatible with cmr imaging 5. known allergic or hypersensitivity reaction to components of the study medications 6. any other reason for which the investigator deems a subject unsafe or inappropriate for study participation.

Keywords: premature adults premature premature cardiac function mri sildenafil metoprolol cmr
gallium ga 68-dotatate pet/ct in diagnosing patients with metastatic castration resistant prostate cancer

Conditions: Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v7

Summary: this pilot clinical trial studies how well gallium ga 68-dotatate positron emission tomography (pet)/computed tomography (ct) works in treating patients with castration resistant prostate cancer that has spread to other placed in the body. gallium ga 68-dotatate pet/ct may help doctors to identify those patients with early neuroendocrine transdifferentiation and who are at greater risk for poor outcomes.

primary objective: establish the feasibility of using gallium ga 68-dotatate (68ga-dotatate) pet as a predictive imaging biomarker for neuroendocrine transdifferentiation in prostate cancer. secondary objective: correlate progression of disease with degree of uptake on 68ga-dotatate pet examination. outline: patients receive gallium ga 68-dotatate intravenously (iv). within 55-70 minutes, patients undergo pet/ct. after completion of study, patients are followed up for at least 1 year.

Eligibility criteria:
inclusion criteria: * patients with metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement * ability to lie still for pet scanning * patients must be able to provide written informed consent exclusion criteria: * patients less than 18 years of age * patients without metastatic castration resistant prostate carcinoma with skeletal, visceral and/or nodal involvement * inability to lie still for pet scanning * patients unable to provide written informed consent
preparing for the final phase of hepatitis c elimination. cairns final 30%

Conditions: Hepatitis C

Summary: the study aims to assess the impact of models of hcv care on hcv testing, treatment uptake and cure within cairns. point of care testing for hcv , with test and treat strategies will be offered within a primary care service.

available testing and treatment data will be explored pre and post the intervention period of the project within cairns hinterland health services that provide hepatitis c care. test and treat strategies of the project will include: part a: same day test and treat clinical trial. the study will explore a 'same day test and treat' model to determine the impact on hcv treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis c that are transient, and struggle to return to a care provider to engage in hepatitis c testing and care. 1. hcv rna point of care (poc) testing 2. epclusa (sofosbuvir/velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve hcv rna result from the poc test. part b: refresher and clinic in reach support work primary care service/ general practitioner education and training \~1 hour in-person training for all clinic staff on hepatitis c testing, treatment, retention in hcv care cascade. part c: services evaluation with incentive and peer intervention in hcv care cascade.

Eligibility criteria:
inclusion criteria: * attending primary health care service of chhs aged 18 years or over exclusion criteria: only for intervention arm test and treat * known to have hepatitis b or hiv infection * known to have cirrhosis * previous treatment with direct acting antivirals * previously received interferon-based hepatitis c treatment that did not work * women that are pregnant or breastfeeding * already receiving hepatitis c treatment.
ceftobiprole in the treatment of hospitalized patients with staphylococcus aureus bacteremia

Conditions: Bacteremia

Summary: the purpose of this study is to assess the safety and efficacy of ceftobiprole versus a comparator in hospitalized patients with bacteremia.

ceftobiprole medocaril is a cephalosporin antibiotic with anti-mrsa (methicillin-resistant staphylococcus aureus) activity. ceftobiprole medocaril in not approved for the treatment of bacterial blood stream infections. s. aureus is a major human pathogen. it causes a wide range of serious infections, including skin and skin structure infections, infections of vascular devices and catheters, and infections of the heart and lungs, bones and joints, and deep tissues. particularly challenging and difficult to treat are blood-borne infections (bacteremia). bacteremic infections are prone to relapse and they are often complicated by metastatic seeding of sites throughout the body. mrsa strains are increasing in prevalence, incidence, and virulence. moreover, the frequency of patients presenting with persistent mrsa bacteremia appears to be rising. the objective of the open label trial is to compare the effectiveness and safety of ceftobiprole versus a comparator in patients with mrsa and mssa (methicillin-susceptible staphylococcus aureus) in bacteremic patients. patients who meet inclusion and exclusion criteria and consent to participate in the study will be randomly assigned to either ceftobiprole or comparator. the primary end point is time to bloodstream clearance of mrsa and mssa in patients. patients will be randomized to either ceftobiprole or comparator for 7 days.

Eligibility criteria:
inclusion criteria: * hospitalized patients with signs and symptoms suggestive of systemic staphylococcal infection as defined in the protocol * female patients must be postmenopausal (for at least 1 year), surgically sterile or practicing an effective method of birth control, male partner sterilization or, at the discretion of the investigator, abstinence, before entry and throughout the study and have a negative urine pregnancy test (confirmed with a negative serum pregnancy test) at screening. exclusion criteria: * female patients who are pregnant or lactating * known or suspected hypersensitivity to beta-lactam antibiotics or any other study medications * receipt of vancomycin or other antistaphylococcal drug for \> 2 calendar days prior to initiation of study drug * diagnosis of a catheter-related gpc-cl bacteremia at the time of study enrollment * clinical findings of left-sided endocarditis prior to enrollment or any time during study participation * requirement for surgery during the seven days of study therapy administration with the exception of surgery required to manage a complication of s. aureus bacteremia

Keywords: bacteremia bloodstream infection staphylococcus aureus staphylococcal infections mrsa mssa
feasibility of the memory and attention adaptation-training geriatrics intervention in older cancer survivors with mild cognitive impairment

Conditions: Cognitive Dysfunction

Summary: cancer-related cognitive dysfunction (crcd) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing crcd, which can negatively affect their functional independence and quality of life. memory and attention adaptation training-geriatrics (maat-g) is a cognitive behavioral therapy-based intervention tailored specifically for older adults and the feasibility of maat-g in older cancer survivors with mild cognitive impairment (mci) is being evaluated.

cancer-related cognitive dysfunction (crcd) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing crcd, which can negatively affect their functional independence and quality of life. memory and attention adaptation training-geriatrics (maat-g) is a cognitive behavioral therapy-based intervention tailored specifically for older adults. maat-g is a series of 10 workshops delivered by a trained health profession via videoconferencing technology. the feasibility of maat-g in older cancer survivors with mild cognitive impairment (mci) is being evaluated.

Eligibility criteria:
inclusion criteria: 1. be age 65 or older 2. able to provide informed consent. all patients will be assessed using the university of california, san diego brief assessment of capacity to consent (ubacc)56 - a score \>14.5 will define ability to independently provide informed consent. for patients scoring \<14.5, or if investigators have additional concerns, we will require that their health care proxy participate in the consenting process and sign an informed consent and patients will required to provide assent. 3. able to read and understand english 4. have a prior diagnosis of cancer and completed curative intent chemotherapy. patients are permitted to be receiving maintenance therapy (e.g. endocrine therapy) in the adjuvant setting. 5. have a clinical diagnosis of mci, a score \<26 on the montreal cognitive assessment (moca), or a score \<18 on the montreal cognitive assessment-blind (moca-blind). if the patient had a moca evaluation completed as a part of routine clinical care in the preceding 3 months prior to consent date, this may be used for eligibility purposes. 6. be independent in activities of daily living (adl)

Keywords: cancer-related cognitive difficulties mild cognitive impairment
zenith tx2® post-market approval study

Conditions: Descending Thoracic Aortic Aneurysm

Summary: the zenith tx2® post-market approval study is a clinical trial approved by us fda to further study the safety and effectiveness of the zenith tx2® taa endovascular graft in the treatment of thoracic aortic aneurysms.


Eligibility criteria:
inclusion criteria: * descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or * descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or * descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter exclusion criteria: * age less than 18 years * other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years) * pregnant, breast-feeding, or planning on becoming pregnant within 24 months * unwilling or unable to comply with the follow-up schedule * inability or refusal to give informed consent * simultaneously participating in another investigative device or drug study

Keywords: endovascular aneurysm repair aortic aneurysm thoracic
israeli judicious antibiotic prescription study

Conditions: Antibiotic Use; Carriage of Antibiotic Resistant Pathogens

Summary: this study aims to implement judicious antibiotic prescription habits to primary care pediatricians using a multifacet educational intervention and assess two main outcomes: 1) direct outcome - prescription rates of the physicians. 2)indirect outcome - carriage of antibiotic resistant bacteria by the treated population, specifically nasopharyngeal s. pneumoniae, nasal s. aureus and rectal e.coli.

background: bacterial antibiotic resistance is an increasing problem. aims: this study aims to implement judicious antibiotic prescription habits among 30 physicians and their treated population as compared to a control group of 30 physicians and their treated population. the outcomes to be measured are: 1. change in antibiotic prescriptions to the treated patients of the intervention vs. control physicians during the study period (4years). 2. change in carriage of antibiotic resistant pathogens, specifically nasopharyngeal penicillin resistant s. pneumoniae,nasal mrsa, and rectal quinolone resistant e. coli. study design: all primary care pediatricians of hashfela district of macabbi healthcare services who will agree to participate will be randomly assigned to an intervention or control group. the intervention group will be led by local leaders (primary care physicians from that district) and will take part in educational activities involving annual workshops and quarterly focus group meetings. the intervention is a multifacet intervention that will include guideline preparation, knowledge building, dealing with uncertainties, etc. the patients of both intervention and control physicians will be screened twice a year for carriage of the bacteria mentioned above. cross-sectional screening of the treated population will be carried in summer and winter for 5 consecutive years. screening will include signing an informed consent, filling a questionnaire and screening with nasal, nasopharyngeal and rectal swabs.

Eligibility criteria:
inclusion criteria: * all treated patients of the participating physicians under the age of 5y, who came for any reason for a visit during the study period, who's parents agreed to participate. exclusion criteria: the only reason to exclude a child from being recruited was age\>5y or refusal of the parent/child to participate.

Keywords: antibiotic use antibiotic prescription antibiotic resistant s. pneumoniae mrsa
butterfly - clinical performance study

Conditions: COVID-19; Coronavirus Infections

Summary: this prospective clinical performance study is a non-interventional, multi-center study to evaluate the assay performance of the covid-19 test using upper respiratory specimens. prospectively collected nasopharyngeal and anterior nasal swabs will be collected from each participant recruited in the study.

the applied biosystems™ taqpath™ covid-19 diagnostic pcr kit (referred to as "covid-19 test") aims to develop a reverse transcription, real-time polymerase chain reaction (rt-qpcr) test for the qualitative detection of sars-cov-2. the purpose of this study is to evaluate the clinical performance of the taqpath™ covid-19 diagnostic pcr kit (covid-19 test) in nasopharyngeal swabs and anterior nasal swabs from symptomatic individuals suspected of covid-19 by their health care provider. a composite comparator approach will be used to evaluate the performance of the covid-19 test which includes the use of three highly sensitive sars-cov-2 molecular assays as comparators. clinical calls will be compared between covid-19 test and the three composite comparators. the third comparator assay will only be used to test samples that show discrepant clinical calls between the first two comparator methods, for a two-out-of-three result interpretation. the clinical performance study protocol (cps protocol) outlines the clinical sample collection and testing protocols which will be used to satisfy the fda 510(k) study requirements in the us.

Eligibility criteria:
inclusion criteria: participants of all ages must meet the following inclusion criteria to be eligible for participation in the study: * ability to provide informed consent or assent (as age-appropriate). stated willingness and ability to comply with the study procedures including nasopharyngeal and anterior nasal swab collection. * individuals with at least one of the following covid-19 symptoms: 1. fever or chills 2. congestion or runny nose 3. headache or fatigue 4. muscle or body aches b. new loss of taste or smell c. a new or worsening cough or sore throat d. shortness of breath or difficulty breathing e. decrease in appetite, nausea, vomiting, diarrhea. * subjects suspected of having covid-19 symptoms for seven (7) or fewer days. exclusion criteria: participants meeting the following criterion will be excluded from the study: * subjects suspected of having covid-19 symptoms for greater than seven (7) days. * subjects who have provided upper respiratory tract samples for other clinical studies within twenty-four (24) hours
the effect of serum calcium levels on postoperative pain: a prospective observational study

Conditions: Postoperative Pain

Summary: this is a prospective observational study. to investigate the effect of serum calcium levels on postoperative pain in patients undergoing abdominal surgery, and to determine whether changes in serum calcium levels are a risk factor for postoperative pain.

this study aimed to measure the total serum calcium and ionized calcium levels both before and after surgery. additionally, nrs scores were recorded at different time points.

Eligibility criteria:
inclusion criteria: * aged 18-70 years old * american society of anesthesiologists classification i-iii * patients undergoing elective abdominal surgery under general anesthesia * patients participate voluntarily and sign an informed consent form exclusion criteria: * patients with a history of severe disease * patients with chronic preoperative pain and/or long-term analgesic use * patients with hearing disorders or verbal communication difficulties * patients with psychiatric disorders or cognitive dysfunction * patients requiring mechanical ventilation or icu admission after surgery * patients with a history of substance or alcohol abuse patients who could not cooperate with the study for any reason

Keywords: serum calcium levels postoperative pain ionized calcium levels
experience of arab american women with breast cancer: in-depth interviews

Conditions: Breast Cancer

Summary: the investigators are conducting a study entitled 'experience of arab american women with breast cancer: in-depth interviews' through which they hope to learn more about arab women's experience with breast cancer.


Eligibility criteria:
inclusion criteria: * amber participant diagnosed with breast cancer who attended at least 1 support group meeting * aged 18 to 85 * arabic-speaking exclusion criteria: none

Keywords: support group 15-246 the arab american breast cancer education and referral program (amber)
trial to compare the safety, efficacy and immunogenicity of tx05 with herceptin® in her2+ early breast cancer

Conditions: Breast Cancer; Breast Neoplasms; HER2-positive Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer

Summary: this is a phase iii, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of tx05 (trastuzumab) with herceptin® in subjects with her2 positive early breast cancer.


Eligibility criteria:
key inclusion criteria: * histologically confirmed her 2 overexpressing invasive primary operable stage ii/iiia breast cancer (ajcc version 7 staging criteria). * available tumor tissue for central review of her2 status. * planned surgical resection of breast tumor. * planned neoadjuvant chemotherapy. * documentation of her2 gene amplification or overexpression. * ipsilateral, measurable tumor longest diameter \> 2 cm. * known estrogen receptor (er) and progesterone receptor (pr) hormone status (may be performed during screening). * ecog performance status of 0 or 1. * adequate bone marrow, hepatic and renal functions. * left ventricular ejection fraction (lvef) ≥ 50% or within institutional normal limits, measured by echocardiography or muga scan. * effective contraception as defined by protocol. key exclusion criteria: * investigational therapy within 2 months of first dose of study drug. * bilateral breast cancer. * inflammatory breast cancer * metastases. * prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer. * cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug. * clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension. * major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug. * pre-existing clinically significant grade 2 peripheral neuropathy. * malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer). * severe dyspnea at rest requiring oxygen therapy. * known positive hiv, acute or chronic active infection with hepatitis b or hepatitis c. * current pregnancy or breastfeeding. * pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.

Keywords: trastuzumab herceptin
the use of proximal carpal row versus iliac crest as bone graft in total wrist fusion

Conditions: Wrist Arthritis; Fusion; Joint

Summary: study purpose is to compare the outcome after total wrist arthrodesis (twa) with proximal carpal row (proximal row carpectomy = prc) as bone graft versus iliac crest cancellous bone graft. patients with radiologically and clinically confirmed advanced osteoarthritis are randomized (1:1 computer generated sequence with random block size) to two parallel groups and will undergo either total wrist arthrodesis with prc or twa with iliac crest bone grafting. baseline data is collected preoperatively and is a follow-up visits at every 6 weeks after the surgery is arranged until the wrist is fused. the primary end-point is 6 months and the primary outcome is fusion rate.


Eligibility criteria:
inclusion criteria: * age 18 - 75 * symptom duration \> 3 months * american society of anaesthesiologists physical status (asa) i-iii * fluent in written and spoken finnish exclusion criteria: * age \ 75 years * rheumatoid arthritis * heavy smoking (\> 20 cigarettes per day) * condition or medication affecting bony healing (eg diabetes mellitus with poor glycemic control, malnutrition, use of per oral corticosteroids) * ulnar variance \> 1 mm * wrist pain treatable with partial wrist fusion * previous partial wrist fusion * alcohol or drug abuse * neurological condition affecting upper limb function * less than 6 months after another operation of the same upper limb
nccls interpretive criteria for salmonella

Conditions: Salmonella Infection

Summary: to determine the clinical significance of gene mutations encoding antibiotic resistance, but not expressed as clinical resistance, in salmonella bacteria

observational study. physicians in foreign countries caring for patients with salmonella meningitis or bloodstream infections will collect data on the patients they care for and send this data and an isolate of the organism causing the infection to the university of pittsburgh.

Eligibility criteria:
inclusion criteria: * salmonella positive isolate

Keywords: salmonella