Kornimate/medical-research-clean huggingface dataset:
post-market evaluation of the rotation medical rotator cuff system

Conditions: Partial Thickness Supraspinatus Tendon Tear; Full Thickness Supraspinatus Tendon Tear

Summary: the purpose of this study is to evaluate bioinduction of new tissue and tendon healing after implantation of the rotation medical bioinductive implant used as either a standalone device or adjunct to surgical repair in the treatment of supraspinatus tendon tears.


Eligibility criteria:
inclusion criteria subjects enrolled in the study must meet all of the following criteria: 1. at least 21 years of age 2. rotator cuff tear requiring surgery that meets either criterion a or b: a. medium or large partial-thickness tear or very small full-thickness tear of the supraspinatus tendon planned for standalone treatment (no surgical repair with sutures/suture anchors) with the bioinductive implant b. medium or large full-thickness tear primarily of the supraspinatus tendon planned for treatment with the bioinductive implant adjunctive to surgical repair 3. chronic shoulder pain lasting longer than 3 months unresponsive to conservative therapy including, but not limited to, pain medication, physical therapy and injections 4. mri of the shoulder within 60 days prior to the study procedure 5. willing to comply with the prescribed post-operative rehabilitation program 6. willing to be available for each protocol-required follow-up examination 7. able to understand the informed consent process, including regulatory requirements such as hipaa authorization, and document informed consent prior to completion of any study-related procedures 8. ability to read, understand, and complete subject-reported outcomes in english exclusion criteria subjects enrolled in the study must not meet any of the following criteria: 1. massive rotator cuff tears (≥ 5 cm) 2. acute rotator cuff tears less than 12 months from injury 3. previous rotator cuff surgery on the index shoulder 4. instability of the index shoulder 5. chondromalacia of index shoulder ≥ grade 3 6. fatty infiltration of the index shoulder rotator cuff muscle ≥ grade 2 7. calcification of the index shoulder rotator cuff 8. genetic collagen disease 9. history of insulin dependent diabetes 10. history of auto-immune or immunodeficiency disorders 11. history of chronic inflammatory disorders 12. oral steroid use in last 2 months or injectable steroid use in last 4 weeks 13. history of heavy smoking (\> 1 pack per day) within last 6 months 14. hypersensitivity to bovine-derived materials 15. females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study 16. currently involved in any injury litigation or worker's compensation claims relating to the index shoulder 17. enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study 18. history of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation 19. history of cognitive or mental health status that interferes with study participation
association between lumbar muscle atrophy, sagittal pelvic alignment and stenosis grade in patients with degenerative lumbar spinal stenosis

Conditions: Lumbar Spinal Stenosis (LSS)

Summary: this study is to evaluate the correlation between muscle atrophy (ma), sagittal alignment, and stenosis degree in patients with lumbar spinal stenosis (lss). from existing radiological images, specific radiographic parameters will be extracted. general information (age, sex, levels of stenosis, duration of symptoms) will be extracted from patient files.


Eligibility criteria:
inclusion criteria: * diagnosis of degenerative lumbar spinal stenosis * upright standing sagittal plane x-ray of lumbar spine with clear visibility of pelvis sacrum and femoral head * mri of the lumbar region with clear visibility of different muscle atrophy grade * consent that health related information can be used for research was signed exclusion criteria: * other spinal disease such as severe scoliosis, fracture, spondylolisthesis and ankylosing spondylitis. * neuromuscular diseases such as m.parkinson or multiple sclerosis * previous surgery of the spine * infection and/or malignancy tumor with involvement of the bony or soft tissue structures of the spine * presence of a documented consent dissent.

Keywords: paraspinal muscle atrophy (ma) sagittal pelvic alignment degenerative spine diseases stenosis grade (sg) degenerative lss goutallier classification
phase ii study of oral pha-848125ac in patients with thymic carcinoma

Conditions: Thymic Carcinoma

Summary: the intent of the study is to assess the antitumor activity of pha-848125ac as second-line treatment in patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy.

the simon's optimal 2 stage design is adopted for this single-arm, open-label, multicenter phase ii clinical trial of pha-848125ac administered to patients with recurrent or metastatic, unresectable thymic carcinoma previously treated with chemotherapy (only one prior systemic therapy allowed). the intent of the study is to assess the antitumor activity of pha-848125ac and ultimately to improve the outcome of patients with thymic carcinoma who have already exploited one chemotherapy option. the primary end point for this study is a progression free survival rate of 3 months.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proven diagnosis of unresectable b3 thymoma or thymic carcinoma recurrent or progressing after prior chemotherapy (only one prior systemic therapy allowed) * presence of measurable disease * age \>=18 years * ecog performance status 0-1 * negative pregnancy test (if female in reproductive years) * use of effective contraceptive methods if men and women of child producing potential * adequate liver function total serum bilirubin \<=1.5 x upper limit of normal (uln) transaminases (ast/alt) \<=2.5uln (if liver metastases are present, then \<=5uln is allowed) alp \<=2.5uln (if liver and/or bone metastases are present, then \<=5uln is allowed) * adequate renal function serum creatinine \ 60 ml/min. * adequate hematologic status anc \>=1,500cells/mm3 platelet count \>=100,000cells/mm3 hemoglobin \>=9.0g/dl * two weeks must have elapsed since completion of prior chemotherapy, minor surgery, radiotherapy (provided that no more than 25% of bone marrow reserve has been irradiated) * resolution of all acute toxic effects of any prior treatments to nci ctc (version 3.0) grade \<=1 exclusion criteria: * any of the following in the past 6 months: myocardial infarction, uncontrolled cardiac arrhythmia, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis * grade \>1 retinopathy * known brain metastases * known active infections * pregnant or breast feeding women * diabetes mellitus uncontrolled * gastrointestinal disease that would impact on drug absorption * patients under treatment with anticoagulants or with coagulation disorders or with signs of hemorrhage at baseline * patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), parkinson's disease and extra-pyramidal syndromes * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that make the patient inappropriate for entry into this study

Keywords: b3 and c malignant thymoma
hypofractionated stereotactic radiotherapy for patients with recurrent high grade glioma

Conditions: Recurrent High Grade Glioma

Summary: the study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

investigators designed this study of a re-irradiation with single radiosurgery or hypofractionated intensity modulated radiation therapy (imrt) with or without temozolomide. objective of the study is evaluating efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.

Eligibility criteria:
inclusion criteria: * age \> 18 years * karnosky performance status (kps) ≥70 * patients aged \>70 years with kps ≥80 * histopathologically confirmed grade iii-iv glioma * estimated survival ≥ 3 months * any tumor volume * unifocal tumor * interval time from previous radiotherapy ≥ 6mesi * normal liver, kidney and bone marrow function * written informed consent exclusion criteria: * kps \< 70 * multifocal tumor * other primary cancer * pregnant women
a two-part, single-blind, phase 3 study evaluating the efficacy and safety of patiromer for the treatment of hyperkalemia (opal)

Conditions: Chronic Kidney Disease (CKD); Hyperkalemia (HK)

Summary: the purpose of this study was to evaluate the efficacy and safety of patiromer (investigational drug) in the treatment of hyperkalemia (high serum potassium). the study also evaluated the effect of withdrawing patiromer treatment and assessed whether chronic treatment with patiromer prevented the recurrence of hyperkalemia. the safety of patiromer treatment was also evaluated.

there were two parts in the study, part a and part b. part a was an assessment of 4 weeks of dosing with patiromer in the treatment of hyperkalemia; part b was a randomized, placebo-controlled, 8-week assessment of the withdrawal of patiromer in participants with a baseline serum potassium at the beginning of part a ≥ 5.5 meq/l who responded to the 4 weeks of treatment with patiromer during part a. all participants received patiromer during part a; part b participants were randomized to continue patiromer or switch to placebo. total study participation was up to 14 weeks (including up to 2 weeks of follow up). the dose of patiromer could be titrated based on participant's serum potassium response.

Eligibility criteria:
inclusion criteria: * males and females ages 18 - 80 * chronic kidney disease (ckd) - egfr 15 to \< 60 ml/min/1.73m2 at screening * hyperkalemia, defined as a serum potassium value of 5.1 to \< 6.5 meq/l at screening * taking either an angiotensin-converting enzyme (ace) inhibitor, an angiotensin ii receptor blocker (arb), or an aldosterone antagonist (aa) medication * informed consent given exclusion criteria: * participants with auto-immune related chronic kidney disease such as lupus nephritis or renal scleroderma/scleroderma renal crisis, or mixed connective tissue disease with renal involvement * participants with uncontrolled type 1 diabetes, defined as or a hba1c \> 10.0 %, or hospitalization to treat hyper- or hypo-glycemia in the past 3 months within the previous 6 months in participants with type 2 diabetes * participants with severe heart failure, defined as nyha (new york heart association) class iv * participants with major surgery including thoracic and cardiac, in the past 3 months, or participants with heart or kidney transplant * participants with significant cardiovascular or cerebrovascular events in the past 2 months, such as cardiac arrest, myocardial infarction, or stroke * participants with bmi ≥ 40 kg/m2

Keywords: chronic kidney disease treatment of hyperkalemia hyperkalemia
platelet reactivity and mes during cea

Conditions: Carotid Artery Stenosis; Ischemic Stroke; Myocardial Infarction; Aspirin Resistance

Summary: the purpose of this study is to analyze the association between aspirin efficacy and general platelet reactivity in relation to microembolic signals (mes) during carotid endarterectomy (cea).


Eligibility criteria:
inclusion criteria: * al patients undergoing elective carotid endarterectomy exclusion criteria: * patients requiring a blood transfusion prior to surgery * patients with an inappropriate temporal bone window for transcranial doppler (tcd) * patients on vitamin k antagonists or antiplatelet treatment other then aspirin * patients with an artificial cardiac valve

Keywords: carotid endarterectomy transcranial doppler micro embolic signals platelets aspirin
prednisolone in infantile spasms- high dose versus usual dose

Conditions: Infantile Spasms; West Syndrome

Summary: infantile spasms comprise a difficult to treat type of epilepsy in young children. hormonal treatment, i.e. prednisolone and acth are considered the treatment of choice. there is no consensus on the dosage of prednisolone required for the treatment of infantile spasms. recent data has shown that a high dose (4 mg/kg/day) may be more efficacious than the usual dose (2 mg/kg/day). however, there are no randomized controlled trials comparing these doses. a higher steroid dose may also be associated with more side effects. therefore, this study was planned to compare the efficacy and tolerability of the high dose versus the usual dose in children with infantile spasms, in a randomized open-label trial design


Eligibility criteria:
inclusion criteria: - children aged 3 months to 2 years presenting with epileptic spasms (at least 1 cluster/day) with eeg evidence of hypsarrhythmia or its variants exclusion criteria: 1. children with active systemic illness 2. children with evidence of active tuberculosis 3. severe acute malnutrition ad defined by who (visible wasting/mid upper arm circumference \< 11 cm/pedal edema/weight for height \< 3 sd) 4. children with recurrent illness/chronic systemic illness
adjunctive, low-dose tpa in primary pci for stemi

Conditions: Myocardial Infarction; Percutaneous Coronary Intervention

Summary: strive will evaluate the use of adjunctive, low-dose intracoronary tissue plasminogen activator during primary percutaneous coronary intervention (pci) for patients with st elevation myocardial infarction (stemi) in reducing the incidence of post-procedural myocardial blush (mbg) grade 0/1 or distal embolization.

strive is a prospective, 3-arm, parallel group, blinded, randomized controlled trial evaluating the efficacy of a novel approach to prevent and treat microvascular obstruction thereby reducing major cardiovascular events using intracoronary administration of very low-dose fibrinolytic (tissue plasminogen activator, tpa) directly into the culprit coronary artery during primary pci.

Eligibility criteria:
inclusion criteria: 1. patients with stemi undergoing primary pci and, 2. ecg changes indicating large territory stemi (defined as ≥2mm st-segment elevation in 2 contiguous anterior precordial leads; or ≥2mm st-segment elevation in 2 inferior leads coupled with st-segment depression in 2 contiguous anterior leads for a total st-segment deviation of ≥8mm) and, 3. randomization within 6 to 12 hours of symptom onset and, 4. large thrombus burden with angiographic timi thrombus grade ≥3 after guidewire crossing. exclusion criteria: 1. active internal bleeding or high risk of bleeding or any prior intracranial bleeding. 2. any other absolute or relative contraindication to fibrinolytic therapy. 3. administration of a fibrinolytic ≤24hrs prior to randomization. 4. cardiogenic shock on presentation. 5. left bundle branch block (excluded because the ecg cannot be evaluated for st segment resolution, an outcome of the study). 6. planned upfront use of a glycoprotein iib/iiia inhibitor. 7. any medical, geographic, or social factor making study participation impractical or precluding 1 month follow-up.

Keywords: tpa
plasma exchange in patients with covid-19 disease and invasive mechanical ventilation: a randomized controlled trial

Conditions: Coronavirus

Summary: plasma exchanges with 5% human albumin (2/3 of the exchanged plasma volume) and fresh frozen plasma (ffp: 1/3) in patients with quick \<50% or only with 5% albumin in patients with quick of 50% or more. we will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.

plasma exchange (pe) is a standardized and safe therapeutic procedure, used in the treatment of various diseases that require rapid and prolonged elimination of endogenous and exogenous substances, with deleterious effects on the function of different organs and systems. the efficacy and safety of pe has been demonstrated in patients with fulminant hepatitis (fh), an entity characterized by an exacerbated inflammatory response, multi-organ failure, and high short-term mortality. in fh, plasma exchange improves systemic inflammation, prevents organ failure and renal support requirements, and improves survival. such treatment eliminates important endogenous and exogenous inducers of the systemic inflammatory response (pamps and damps), proinflammatory mediators (cytokines and ros), and other biologically active substances (nitric oxide, prostaglandins, and bradykinin) that are involved in the pathogenesis of organ failure. several case reports also suggest that pe is an effective rescue therapy in critically ill patients with influenza a (h1n1). however, the efficacy of pe has not been evaluated in critically ill patients with covid-19 disease.

Eligibility criteria:
inclusion criteria: 1. male or female subject ≥18 years and \< 80 years of age; 2. subjects with diagnosis of covid-19 disease by pcr in nasopharyngeal smear, sputum, or bronchial aspirates; 3. subjects admitted in icu with invasive mechanical ventilation; 4. informed consent granted via telephone by relatives or legal representative exclusion criteria: 1. more than seven days with invasive mechanical ventilation 2. refractory shock (noradrenaline dose \> 0.5 micrograms/ kg/minute) 3. decompensated cirrhosis 4. chronic kidney disease requiring hemodialysis 5. active neoplastic disease 6. severe chronic heart failure (nyha class iii or iv) 7. severe pulmonary disease (gold iii or iv) 8. hiv infection (aids criteria)
a study to evaluate the antiviral activity and safety of hh-003 injection in subjects with hbeag-negative chronic hepatitis b treated with nucleos(t)ide reverse transcriptase inhibitors

Conditions: Chronic Hepatitis B

Summary: this is a multicenter, randomized, controlled phase iia study of hh-003 injection, hh-003 injection is a monoclonal antibody targeting hepatitis b virus. this study aims to evaluate the antiviral activity and safety in subjects with with hbeag-negative chronic hepatitis b treated with nucleos(t)ide reverse transcriptase inhibitors.


Eligibility criteria:
inclusion criteria: * signed informed consent form; * male or female aged from 18 to 65years (inclusively); * 18 kg/m\^2≤bmi≤32 kg/m\^2, body weight≥45 kg for men and ≥40 kg for women; * at screening, etiological, clinical, or pathological evidence indicates chronic hepatitis b virus infection for at least 6 months; and negative hbeag for more than 6 months; 10 iu/ml≤hbsag≤3000 iu/ml; hbv dna≤20 iu/ml; alt≤1×uln; * participants who have been on the treatment of nucleos(t)ide reverse transcriptase inhibitors (limited to entecavir \[etv\], tenofovir disoproxil fumarate \[tdf\], or tenofovir alafenamide fumarate \[taf\]) for at least 3 years (as judged by the investigator) at screening. exclusion criteria: * females who are pregnant or lactating at screening; * history of alcoholic liver disease, non-alcoholic steatohepatitis, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-hbv infection; * history or presence of progressive liver fibrosis or cirrhosis, including but not limited to liver stiffness measurement \[lsm\] ≥ 9 kpa at screening, progressive liver fibrosis or cirrhosis (e.g., s ≥ 3 in gs score or metavir ≥ f3) by liver histopathology examination, according to the consensus on the diagnosis and therapy of hepatic fibrosis \[2019\]; or the presence of ascites, hepatic encephalopathy, upper gastrointestinal bleeding, or esophageal and gastric varices. * history or presence of hepatocellular carcinoma, or alpha-fetoprotein (afp) ≥ 50 ng/ml at screening; or suspicion of hepatocellular carcinoma indicated by liver ultrasound, ct, or mri. * use of antiviral therapy with interferon within 1 year prior to screening * any of the following lab test results at screening: total bilirubin \>2xuln or direct bilirubin \>1.5xuln, hemoglobin \ 1.3; or estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2.
postoperative pain in children with cerebral palsy after pelvic and femoral osteotomies

Conditions: Postoperative Pain; Cerebral Palsy

Summary: this study is a comparison of postoperative pain in children with cerebral palsy after surgery on the hip or femur. one group is treated with p.o. (by mouth) or intravenous (i.v.) analgesia, and the other group is treated with local infiltration analgesia with naropine. pain is measured with r-flacc, a pain-score validated for children with cerebral palsy.


Eligibility criteria:
inclusion criteria: * age under 18 * informed consent * postoperative cast with spica exclusion criteria: * previous surgery in the same hip * other surgical procedure planned at the same time * bilateral surgery * previous allergic reaction to local analgesia

Keywords: pain postoperative local infiltration analgesia cerebral palsy r-flacc
effect of standard care rehabilitation versus interval treadmill training after myocardial infarction

Conditions: Myocardial Infarction

Summary: the purpose of this study is to investigate the effect of the standard rehabilitation offered by three hospital rehabilitation units in norway, one in trondheim, one in ålesund and one in levanger, compared to an interval treadmill training program. the subjects participating in the study are patients with myocardial infarction. the maximal oxygen consumption of the subjects will be tested before and after the training period.

the purpose of this study is to investigate the effect of the standard rehabilitation offered by three hospital rehabilitation units in norway, one in trondheim, one in ålesund and one in levanger, compared to an interval treadmill training program. the subjects participating in the study are patients with myocardial infarction. the maximal oxygen consumption of the subjects will be tested before and after the training period. primary outcome: maximal oxygen consumption secondary outcomes: blood values (for endothelial function, blood lipids, etc), flow mediated dilatation, quality of life (sf 36 and macnew), weight, bmi, heart rate fall 1 minute after stopping the maximal treadmill test.

Eligibility criteria:
inclusion criteria: * myocardial infarction 2-12 weeks ago exclusion criteria: * heart failure * limitations to walking on a treadmill * failure to reach a maximal pre-test(\> nyha class ii) * uncontrolled hypertension * copd * pregnancy * kidney failure (creatinin \> 140) * drug abuse * left ventricle ef \< 30%

Keywords: oxygen consumption exercise rehabilitation
brain function in children with congenital heart disease (chd)

Conditions: Congenital Heart Disease

Summary: the purpose of the study is to determine whether the neurodevelopmental outcome and in particular executive functions in 9 to 14 year old school children with congenital heart disease who underwent cardiopulmonary bypass surgery during their first three months of life is impaired in comparison to healthy children at same age. executive functions are higher order cognitive functions and critical for school success.


Eligibility criteria:
inclusion criteria: * congenital heart disease, * cardiopulmonary bypass surgery during first three months of life, * no genetic syndrome, * gestational age \> 37 weeks of gestation. exclusion criteria: * heart surgery without cardiopulmonary bypass, * heart surgery not within first three months of life, * born \<37 weeks of gestation, * any genetic syndrome detected.