Kornimate/medical-research-clean huggingface dataset:
coronary calcium scoring versus standard care for emergency department chest pain patients

Conditions: Chest Pain

Summary: this research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. three of four patients will undergo calcium scoring and the remaining patients will receive standard care.


Eligibility criteria:
inclusion criteria: * complaint of chest pain or pressure * intermediate risk by heart score * clinical indication for non-invasive cardiac imaging * free of known coronary artery disease exclusion criteria: * hemodynamic instability * electrocardiogram suggestive of acute ischemia or myocardial infarction * unremitting chest pain * serum troponin levels greater than three times the laboratory threshold * unable to give his/her own written, informed consent * pregnant women * weight \> 182 kg * unable to lie supine for scan * coronary calcium score, coronary cta or non-contrast thoracic ct within the last year and available for review * unable to comply with 30 day follow-up

Keywords: chest pain calcium score coronary calcium score coronary calcium scoring calcium scoring cacs ccs
infant aquatics neurodevelopment premature infants

Conditions: Cerebral Palsy; Preterm Birth; Development

Summary: the objective of this research is to examine the effect of infant aquatics on the development of and neurodevelopment of preterm and near-term infants, using the gm as prognostic estimation of future development. preterm infants, a continuously growing population, are at high risk for neurodevelopment impairments ranging from minor neurological dysfunction (mnd) to cerebral palsy (cp), mainly due to developmental brain injury. infant aquatics have been found to benefit and promote infant development. the support and sensory stimulation of the water may improve the development the sensory, motor, as well as, autonomic system of preterm infants. the study will compare intervention by infant aquatics to infant massage. the intervention in both methods will start at 36 weeks gestational age for 3 months and will consist of sessions with a therapist every 2 weeks. development will be assessed and compared at 3, 8 and 18 months using infant motor pattern method, griffith developmental scales and vineland adaptive behavior scales.


Eligibility criteria:
inclusion criteria: major inclusion criteria: infants who are hemodynamic stable, no seizures or apnea attacks, ivh/pvh grade \< 3, without diagnoses of chromosomal abnormalities, infants whose parents want to cooperate, will be included. these criteria follow our aim to include vulnerable groups of infants for which research results may dramatically promote development. exclusion criteria: infants whose parents are not able to understand research goals and refuse to cooperate, infants with seizures or apnea attacks, ivh/pvh grade \>or =3, with diagnoses of chromosomal abnormalities.

Keywords: neurodevelopment, infant-aquatics, prematurity
effectiveness of artemether-lumefantrine for malaria treatment of children at community level in tanzania

Conditions: Malaria

Summary: the purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in kibaha district, tanzania, during an extended follow-up of 42 days. the hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% pcr-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.


Eligibility criteria:
inclusion criteria: 1. aged \<5 years 2. weight \>5 kg 3. suffering from acute uncomplicated p. falciparum malaria confirmed by rdt. later microscopy using giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µl 4. having a history of fever in the preceding 24 h 5. able to ingest tablets orally 6. willing and able to attend stipulated follow-up visits 7. with written informed consent from parent/guardian for children to participate in the trial. exclusion criteria: presenting with any of the following "danger signs of severe malaria": 1. convulsions (\>1 episode within previous 24 hours) 2. lethargic/unconscious

Keywords: malaria plasmodium falciparum artemether-lumefantrine effectiveness
study of efficacy and safety of bimagrumab in patients after hip fracture surgery

Conditions: Muscle Wasting (Atrophy) After Hip Fracture Surgery

Summary: the purpose of this study was to assess if bimagrumab is safe and effective in patients with muscle wasting (atrophy) after hip fracture surgery.


Eligibility criteria:
inclusion criteria: must have x-ray confirmed successful hip fracture repair; must have completed surgical wound healing; ability to walk a specified distance with or without a walking aid; must weigh at least 35 kg. exclusion criteria: must not have history of any other lower limb fractures in the past 6 months; must not have certain cardiovascular conditions; must not have a chronic active infection (e.g. hiv, hepatitis b or c, etc); must not have used high-dose corticosteroid medications for at least 3 months in the past year;

Keywords: bimagrumab bym338 hip fracture elderly controlled clinical trial randomized muscle wasting atrophy
vascular access in hematological patients - picc versus cvc

Conditions: Vascular Access Complication

Summary: the use of peripherally inserted central catheters (piccs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. in modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and cost-effectiveness compared with centrally inserted central catheters (ciccs).

the use of peripherally inserted central catheters (piccs) represents a major advance for hematological patients, enabling the effective delivery of chemotherapy and/or blood products particularly for prolonged infusions or in situation of difficult venous access. in modern medical practice their use has increased rapidly for several reasons, including ease of insertion, many uses (e.g., drug administration and venous access), perceived safety, and costeffectiveness compared with centrally inserted central catheters (ciccs). despite these benefits, piccs are associated with deep vein thrombosis of the arm and pulmonary embolism. these complications, which are often called venous thromboembolism, are important because they not only complicate and interrupt treatment, but also increase cost, morbidity and mortality. despite this effect, the burden and risk of picc-related venous thromboembolism is uncertain and clinicians have scarce evidence on which to base choice of vascular access. evidence to choose one vascular access over the other is lacking in literature, in particular for patients affected by haematological malignancies, in which chemotherapy is more likely to cause myelosuppression, with a major risk of bloodstream infections. furthermore, the precise incidence and the risk of picc-related venous thromboembolism relative to that of other ciccs is unknown. an understanding of this risk in the context of growing picc use is an important cost and patients safety questions. up to now, no systematic review has been done to investigate these questions.

Eligibility criteria:
inclusion criteria: * age \>18 yrs * newly diagnosed aml * suspected survival \> 4 weeks * need of central venous access \>4 weeks exclusion criteria: * ongoing uncontrolled systemic infection * presence of significant thrombosis/stenosis in arm or central veins * diagnosis of another cancer within 12 months before aml onset * any evidence of clinical conditions indicating unability to receive intent-to- cure chemotherapy * unability to communicate and/or to sign informed consent

Keywords: picc bloodstream infections vascular access deep vein thrombosis cicc
a study to evaluate the efficacy and safety of ak102 q6w in patients with hyperlipidemia

Conditions: Hyperlipidemia

Summary: this is a randomized, double-blind, placebo-controlled phase # clinical study evaluating the efficacy and safety of ak102 q6w in patients with primary hypercholesterolemia and mixed hyperlipidemia.

this is a phase 3 clinical study to evaluate the efficacy and safety of ak102 q6w, a monoclonal antibody against proprotein convertase subtilisin/kexin type 9 (pcsk9), in subjects with primary hypercholesterolemia and mixed hyperlipidemia.

Eligibility criteria:
inclusion criteria: 1. subject understand and voluntarily sign the written inform consent form (icf). 2. male or female ≥ 18 to ≤ 80 years of age. 3. the fasting serum ldl-c level of subjects did not meet the treatment goal after at least 4 weeks of stable lipid-lowering background treatment. 4. tg ≤ 4.5 mmol/l (400 mg/dl) exclusion criteria: 1. known homozygous familial hypercholesterolemia. 2. received pcsk9 inhibitors within 6 months before randomization. 3. known sensitivity to pcsk9 inhibitors and any substances to be administered. 4. severe renal dysfunction. 5. previously received organ transplantation. 6. uncontrolled hypothyroidism or hyperthyroidism. 7. uncontrolled hypertension. 8. known hyperlipidemia secondary to comorbidity, including nephrotic syndrome, cholestatic liver failure, etc. 9. history of malignancy of any organ system within the past 5 years.
tesamorelin to improve functional outcomes after peripheral nerve injury

Conditions: Peripheral Nerve Injuries

Summary: the aim of this clinical trial is to evaluate the efficacy of tesamorelin as a therapy for peripheral nerve injuries. the investigators hypothesize that treatment with tesamorelin will result in faster and more substantial recovery of motor and sensory function following surgical repair of injured peripheral nerves. patients with upper extremity nerve injuries will be randomly assigned to receive either tesamorelin treatment or no treatment. assessments for nerve regeneration, muscle function, and sensation will be conducted every three months for a total of 12 months. outcomes in patients receiving tesamorelin will be compared to those in the untreated group to determine the effectiveness of tesamorelin as a therapeutic intervention for nerve injuries.

this is a randomized, double-blinded, clinical trial assessing the efficacy of tesamorelin as a therapy to improve functional recovery following peripheral nerve injury. tesamorelin is a drug that stimulates increased production of growth hormone, and growth hormone has been shown to improve nerve regeneration and functional recovery in animal studies. a total of 36 participants with repaired ulnar nerve lacerations will be enrolled, of which 18 will be randomly assigned to receive the study drug and 18 will receive no treatment. to minimize bias, outcome assessors and the biostatistician analyzing the data will be blinded to the treatment assignments. following enrollment, each participant will have 12 monthly follow-up visits during which participants will undergo testing to assess recovery. outcome assessments will include clinical exams, electrodiagnostic studies and questionnaires. the total duration of the study is expected to be 4 years.

Eligibility criteria:
inclusion criteria: * ulnar nerve laceration at the wrist, repaired primarily exclusion criteria: * certain cancers (active or in the past) * uncontrolled diabetes or hypertension * certain pituitary problems * oral contraceptives * pregnancy * drug or alcohol dependence * psychosocial issues that would limit participation and compliance
a study of rovalpituzumab tesirine as maintenance therapy following first- line platinum-based chemotherapy in participants with extensive stage small cell lung cancer (meru)

Conditions: Small Cell Lung Cancer

Summary: this is a phase 3, randomized, double-blind, placebo-controlled, multinational, and multicenter study to evaluate the efficacy of rovalpituzumab tesirine as maintenance therapy following first-line platinum-based chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed extensive-stage disease small cell lung cancer (ed sclc) at initial diagnosis with ongoing clinical benefit (stable disease \[sd\], partial response \[pr\], or complete response \[cr\]) following completion of 4 cycles of first-line platinum-based therapy * participant is eligible to be randomized at least 3 but no more than 9 weeks from day 1 of the fourth cycle of first-line platinum-based chemotherapy. * participants with a history of central nervous system (cns) metastases prior to the initiation of first-line platinum-based chemotherapy must have received definitive local treatment and have documentation of stable or improved cns disease status * eastern cooperative oncology group (ecog) performance score of 0 or 1 * participants must have adequate bone marrow, renal and hepatic function * availability of archived or representative tumor material for assessment of dll3 expression exclusion criteria: * any prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, t-cell or other cell-based or biologic therapies, or any other anti-cancer therapy than that described in inclusion criteria for sclc. * any disease-directed radiotherapy (except prophylactic cranial irradiation, palliative radiotherapy to a radiographically documented non-progressing lesion for symptom control, or pre-planned radiotherapy for cns metastases present prior to start of first-line therapy and non-progressing) after last dose of first-line chemotherapy. * prior exposure to a pyrrolobenzodiazepine (pbd-based) or indolinobenzodiazepine-based drug, prior participation in a rovalpituzumab tesirine clinical trial, or known hypersensitivity or other contraindications to rovalpituzumab tesirine or excipient contained in the drug formulation.

Keywords: extensive-stage small cell lung cancer (ed sclc) cancer platinum-based chemotherapy rovalpituzumab tesirine first-line chemotherapy small cell lung cancer (sclc) delta-like protein 3 (dll3)
protein supplementation and skeletal muscle healing process

Conditions: Skeletal Muscle Damage; Exercise-induced Aseptic Inflammation; Skeletal Muscle Performance; Intracellular Signaling in Skeletal Muscle; Proteasome Activation

Summary: in this study the investigators utilized protein supplementation over an 8-day period following eccentric exercise-induced muscle damage in order to test the initial hypotheses : i) protein supplementation after exercise-induced muscle injury affects exercise-induced aseptic inflammation and muscle performance.

the objective was to examine weather protein supplementation is able to affect the inflammatory response as well as recovery of muscle performance following an intense eccentric exercise protocol. in a double-blind, counterbalanced design, 14 men received either placebo (pla) or milk protein isolate (pro) for 8 consecutive days following a single bout of exercise (300 eccentric contractions at 30 deg/sec). in both conditions, performance was assessed at baseline, immediately post-exercise, 2h post-exercise and daily for 8 consecutive days. blood samples were collected at baseline, 2h post-exercise and daily for the remaining 8 days. muscle biopsies from vastus lateralis were collected at baseline as well as at day 2 and day 8 of the post-exercise period.

Eligibility criteria:
inclusion criteria: * a) recreationally trained as indicated by the maximal oxygen consumption levels (vo2max \> 45 ml/kg/min), b) engaged in systematic exercise at least three times per week for \> 12 months, c) non-smokers, d) abstained from any vigorous physical activity during the study, e) abstained from consumption of caffeine, alcohol, performance-enhancing or antioxidant supplements, and medications during the study. exclusion criteria: * a) a recent febrile illness, b) history of muscle lesion, c) lower limb trauma
the value of psp in predicting outcome in icu surgical peritonitis patients

Conditions: Peritonitis; Sepsis; Multiple Organ Failure; Death

Summary: the purpose of this study is to determine the diagnostic accuracy of pancreatic stone protein (psp) in predicting patient outcomes with suspected peritonitis in the intensive care unit after abdominal surgery and compare pps with other blood parameters, including c-reactive protein (crp), white cell count (wcc), interleucin-6 (il-6) and procalcitonin (pct).

peritonitis is a severe complication after abdominal surgery. patients admitted at the intensive care unit (icu) following surgery bear the risk of localized infection, sepsis or septic shock. prevention or early detection of such events is important to intervene with an appropriate therapeutic action and avoid risking a potentially life-threatening situation. white blood cell counts (wcc) and c-reactive protein (crp), interleucin-6 (il-6) and procalcitonin (pct) have all been promising parameters, however, they are useful only in selective cases and have a limited diagnostic accuracy.

Eligibility criteria:
inclusion criteria: * abdominal surgery. * admission to the intensive care unit (icu). * blood sampling within 3 hours from admission to the icu * patient over 18 years of age exclusion criteria: * patients already treated for peritonitis. * patients referred from other hospitals with suspicion of peritonitis * patient age less than 18 years of age.

Keywords: peritonitis sepsis general surgery intensive care units sensitivity and specificity
efficacy of bone-marrow-derived and placenta-derived multipotent mesenchymal stem / stromal cells for osteoarthritis

Conditions: Knee Osteoarthritis

Summary: to define the clinical effects of intra-articular transplantation of bone-marrow-derived (bm-mmscs) and placenta-derived multipotent mesenchymal stem / stromal cells (p-mmscs) for knee osteoarthritis.

multipotent mesenchymal stem / stromal cells (mmscs) of different origin are the novel therapeutic agents that can slow down cartilage degeneration, improve reparation and ultimately prevent joint prosthetics. mscs are capable to direct differentiation into chondrocytes, produce cytokines and growth factors with immunomodulatory and anti-inflammatory effects, stimulate angiogenesis, as well as induce chemotaxis of endogenous progenitors. bone marrow-derived and placenta-derived mmscs can be considered the most promising source for cell therapy of joints disorders according to availability, safety and expected therapeutic efficacy.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of knee osteoarthritis. 2. age: 18 to 75 years old. 3. kellgren-lawrence grade 2 or 3 according to x-ray imaging. 4. knee pain. 5. written informed consent exclusion criteria: 1. age \ 75 years of age by time of infusion. 2. participation in an on-going investigational therapeutic or device trial 30 days of consent. 3. rheumatoid arthritis. 4. psoriatic arthritis. 5. juvenile idiopathic arthritis. 6. gout. 7. infectious arthritis. 8. osteomyelitis. 9. osteonecrosis. 10. inflammatory arthritis. 11. chondropathy. 12. joint contracture. 13. arthroplasty. 14. arthroscopy within 6 months prior to study entry. 15. intra-articular injection within 3 months prior to study entry. 16. hormone intake. 17. antiaggregants and anticoagulants intake. 18. immunosuppressants intake. 19. allergy to hyaluronic acid. 20. history of organ or cell transplantation. 21. hematologic abnormality evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet count \< 100,000/ul. 22. active infection. 23. positive for hiv antigen. 24. history of hepatitis b, hepatitis c. 25. history of malignancy in the last 5 years prior to study entry. 26. active tumors. 27. history of myocardial infarction. 28. history of stroke. 29. renal failure with chronic hemodialysis. 30. liver cirrhosis (icgr 15 \>30%). 31. chromosomal abnormality. 32. peripheral nervous system disorders. 33. cognitive or language barriers that prohibit obtaining informed consent or any study elements. 34. history of drug abuse or alcohol abuse, or documented medical, occupational, or legal problems arising from the use of alcohol or drugs within the past 24 months. 35. pregnant/nursing women or women of child-bearing potential. 36. other condition that limits lifespan to \< 1 year.

Keywords: bm-mmscs; p-mmscs; hyaluronic acid
mineralocorticoid receptor antagonist and pulmonary fibrosis in covid-19.

Conditions: COVID-19 Pneumonia

Summary: in december 2019 sars-cov-2 virus appeared in the world, mainly appearing as an acute infection of the lower respiratory tract. in march 2020, the world health organization (who) announced a pandemic in relation to the disease caused by the sars-cov-2 virus, known as coronavirus disease 2019 (covid-19). since then, the efforts of scientists from around the world have focused on finding the right treatment and vaccine for the new disease. covid-19 has spread rapidly in a few months, affecting patients in all ages. the disease has a varied course, patients can be 80% asymptomatic, but many develop respiratory failure, complicated by sepsis and ultimately death. one of the possible complications associated with covid-19 lung involvement is pulmonary fibrosis, leading to chronic breathing difficulties and prolonged disability. no specific mechanisms leading to this phenomenon have been identified in covid-19, but some information is derived from previous studies on the sars and mers epidemic. there have been several reports that the use of spironolactone may be important in preventing pulmonary fibrosis. the aim of the study is to evaluate the effectiveness of intravenous form of mineralocorticoid receptor antagonist canrenoate potassium (an aldosterone antagonist of the spirolactone group) in the treatment of covid-19-associated pulmonary fibrosis based on the mechanisms of the immune response.


Eligibility criteria:
inclusion criteria: 1. patients of both sexes, 18-90 years of age. 2. patient requiring oxygen therapy, spo2 \<94%. 3. confirmed covid-19 infection. 4. at least one risk factor for increased mortality in the course of covid-19: currently published in the literature e.g. smoking, hypertension, diabetes, cardiovascular disease. 5. documented informed consent according to ich-gcp and national regulations. exclusion criteria: 1. chronic bronchitis, emphysema, interstitial lung disease, or other history of lung disease. 2. contraindications to the use of spironolactone. 3. hypersensitivity to spironolactone or any of the excipients. 4. pregnant patients (pregnancy test will be performed in every patient of reproductive age) and during lactation. 5. patients with mental illness or dementia who are unable to give informed consent to the examination. 6. ards caused by another viral infection (sars-cov-2 negative). 7. ards from other causes/trauma. 8. ionic disorders: hyperkalemia, hyponatraemia. 9. adrenal crisis. 10. acute and chronic renal failure, creatinine clearance less than 30 ml/min. 11. anuria. 12. porphyria.

Keywords: covid-19 spironolactone pneumonia fibrosis sars-cov-2 potassium canrenoate