Kornimate/medical-research-clean huggingface dataset:
clinical randomisation of an anti-fibrinolytic in symptomatic mild head injury in older adults

Conditions: Traumatic Brain Injury

Summary: tranexamic acid (txa) reduces head injury deaths. the crash-4 trial aims to assess the effects of early intramuscular txa on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury

txa reduces bleeding by inhibiting the enzymatic breakdown of fibrin blood clots. results from randomised trials (crash-3 and nct01990768) show that early treatment with txa (given intravenously) reduces head injury deaths (pooled rr 0.89, 95% ci 0.80-0.99). in the crash-3 trial, the reduction in head injury deaths with txa was largest in patients with mild and moderate head injuries, particularly if patients were treated soon after injury. however, the crash-3 trial included mild tbi patients only if they had intracranial bleeding on ct scan. it is uncertain whether the results apply to mild tbi patients more generally. crash-4 is a randomised, double blind, placebo-controlled trial in symptomatic mild tbi in about 10,000 older adults. the pilot phase will include about 500 patients. the trial aims to provide reliable evidence about the effects of early intramuscular txa on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.

Eligibility criteria:
inclusion criteria: * 50 years or older (actual or estimated) * history or evidence of head injury (e.g. laceration, bruise, swelling or pain in head or face) * gcs ≥ 13 * has one or more of the following: 1. has or had any impaired consciousness (loss of consciousness, amnesia, or confusion) 2. nausea or vomiting * within 3 hours of injury (do not include if interval cannot be estimated e.g. patient unable to confirm time of fall or patient found on floor after an unwitnessed fall and home alone) * not living in a nursing home, mental health institution or prison * patient will be conveyed to or is admitted to a participating hospital exclusion criteria: - txa not clearly indicated (e.g. major bleeding) or contraindicated (e.g. suspected stroke)

Keywords: traumatic brain injury, tranexamic acid, older adults
orca - oracea® for rosacea: a community-based assessment

Conditions: Rosacea

Summary: the objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.


Eligibility criteria:
inclusion criteria: * males and females aged 18 and older * subjects with diagnosis of rosacea (iga of 2 to 4) exclusion criteria: * subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin) * subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit * subjects who had laser or ipl (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study * subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications * subjects who have stomach or gi problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded
immunosupressive treatment in covid-19 patients

Conditions: COVID-19 Infection

Summary: sam-covid is a retrospective cohort study that aims to determine the impact of immunosuppressive drugs and immunoglubulins in the outcome of patients with covid-19.

sam-covid is a retrospective cohort study of patients admitted to 66 spanish hospitals with laboratory-confirmed covid-19 infection by real-time polymerase chain reaction (rt-pcr) assay for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) presenting during admission with clinical and laboratory data suggestive of macrophage activation syndrome with the objective to investigate whether the use of immunosuppressive drugs (including high-dose steroids, tocilizumab, sarilumab, anakimra) or immunoglobulins in avoiding the need for invasive mechanical ventilation or in-hospital death. the ethics committee for research of virgen macarena and virgen del rocío university hospitals approved the study and waived the need to obtain informed consent. the data source was the electronic medical records. all data were entered directly by personnel at each institution using an online case report form (crf), that satisfied local requirements of data confidentiality. the variables registered included administrative data, epidemiological information, type of clinical specimen in which the diagnosis was confirmed, demographics, comorbidities and current medications, signs and symptoms at admission, baseline laboratory tests results and at day 0, chest x-ray findings at baseline and during follow-up, medications with potential activity against covid-19, supportive treatments including oxygen therapy, use of immunosuppressant medications or immunoglobulins, and outcome.

Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) admitted because of covid-19 confirmed by pcr in nasopharyngeal swab or lower respiratory tract sample and presenting on a specific date (day 0) one clinical and one laboratory criteria of the following: clinical criteria: * temperature ≥38ºc. * worsening in oxygen requirements to achieve o2 saturation \>92%. laboratory criteria: * ferritin \>2000 ng/ml or increment in \>1000 ng/ml since admission. * d-dimer \>1500 µg/ml (or duplicate in 24h) * il6 \>50 pg/ml. exclusion criteria: * mechanical ventilation in day 0. * decision of provide only palliative care before day 0. * use of systemic steroids, tocilizumab, other immunosupressors, or immunoglobulins before day 0.

Keywords: covid-19 sars-cov-2 immunosuppressive immunoglubulins
prevention of levodopa-induced dyskinesias by transcranial static magnetic field stimulation (tsms)

Conditions: Dyskinesia, Medication-Induced; Parkinson's Disease

Summary: this is a randomized sham-controlled double-blind study to test the hypothesis that transcranial static magnetic field stimulation (tsms) of the motor cortex improves levodopa-induced dyskinesias in patients with parkinson's disease. half of the patients will receive real tsms treatment, the other half will receive sham treatment (placebo).


Eligibility criteria:
inclusion criteria: * advanced idiopathic parkinson's disease (brain bank criteria) * optimal clinical response to dopaminergic medication (\>30% updrs-iii improvement) * presence of clinically relevant levodopa-induced peak-dose dyskinesias in at least one upper limb exclusion criteria: * mri-incompatible metal objects in the body (e.g. cardiac pacemakers) * other main neuropsychiatric co-morbidity
cross-training and locomotor abilities in cerebral palsy

Conditions: Cerebral Palsy (CP); Spastic Hemiparesis

Summary: the purpose was to investigate the effect of cross-training as a method of unilateral motor priming on locomotor abilities in children with spastic unilateral cerebral palsy.

thirty children with spastic unilateral cerebral palsy were recruited from different rehabilitation centers. they were assigned randomly into two groups. children in the control group (a) were engaged in a selected physical therapy program while those in the experimental group (b) received cross-training program followed by application of the same selected physical therapy program received by group (a). the treatment programs were conducted five times per week for six successive weeks. measurements obtained included active ankle dorsiflexion range of motion (arom), and the speed of walking obtained by 10-meter walking test. these measures were recorded two times: pre- and post-treatment.

Eligibility criteria:
inclusion criteria: * spasticity grade 1 to 1+, according to the modified ashworth scale. * can stand and walk autonomously. * able to follow verbal commands and instructions. exclusion criteria: * fixed musculoskeletal deformities * significant cognitive disorders * significant perceptual disorders * significant auditory disorders * significant visual disorders
calypso-based deep inspiration breath hold (dibh) radiation treatments of lung cancer

Conditions: Non-small Cell Lung Cancer (NSCLC)

Summary: the purpose of this study is to test the use of calypso beacon implants as a way to determine where the lung tumor is located during radiation treatment. the calypso beacons are small devices that are implanted in the lungs, near the tumor. they are able to send a signal to a tracking system to show where they are, and where the tumor is, as the patient holds their breath for the radiation treatment. the investigators want to find out what effects, good and/or bad, that this has on the patient and the way they treat the cancer in your lungs.


Eligibility criteria:
inclusion criteria: * patients must have histologic proof of malignancy suitable for thoracic radiation therapy * patients planning to undergo radiation therapy for primary or recurrent malignancy of the lung or metastatic malignancy to the lung. * age ≥ 18 years old * kps ≥ 60% * ability to hold their breath for \>20 seconds for 5 times * patients who are able to tolerate flexible bronchoscopy * patients with life expectancy of at least 12 months * patients able to have bronchoscopic placement of calypso as confirmed on a recent (within the past 8 weeks) ct scan. * patients who are able to comply with the protocol follow-up schedule. exclusion criteria: * patients unable to comply with instructions for dibh * patients with implants in the chest region that contain metal or conductive materials (e.g., metal implants, rods, or plates) which calypso medical considers will interfere with the calypso system's electromagnetic localization. * patients with active implanted devices, such as pacemakers, defibrillators, and drug infusion pumps since the effects of the calypso system operation on these devices are unknown. * patients with clinically significant active infections. * patients with bronchiectasis in the region of the intended implantation sites. * patients with a history of hypersensitivity to nickel. * patients whose lung tumors are being monitored with mr imaging (mr imaging of the anchored transponders is safe but yields an image artifact around the anchored transponders). * posterior lesions that would be \>19cm distance from calypso detector plate. patients may be treated in the prone position in order to meet the required minimum distance. * patients with any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in this clinical study. * patients who are deemed unable to safely undergo or tolerate flexible bronchoscopy * patients who are unable to tolerate anesthesia or sedation * patients enrolled in any other clinical studies the investigator believes to be in conflict with this investigation. * female patients who are pregnant or nursing

Keywords: calypso-based deep inspiration breath hold (dibh) radiation treatments 13-174
utility of interface pressure mapping

Conditions: Ulcers; Bedsores

Summary: to determine if a device that measures and displays pressure that the patients feel when in bed can help nurses reposition the patient effectively and thereby reduce bedsores in the intensive care unit.


Eligibility criteria:
inclusion criteria: * 18 years and older, * care giver trained on mapping system exclusion criteria: * less than 18 years, * pregnant women, * weight greater 550 lbs, and subjects requiring a specialty mattress

Keywords: patients susceptible to hospital acquired pressure
thromboprophylaxis in patients undergoing orthopedic surgeries; using propensity score matching

Conditions: Thrombosis; Deep Vein Thrombosis; Surgery--Complications

Summary: venous thromboembolism (vte), including deep vein thrombosis (dvt) and pulmonary embolism (pe), is a common post-operative complication. the necessity for anticoagulant therapy after orthopedic surgeries is widely understood, but treatment administration patterns in the prevention of venous thromboembolism (vte) after orthopedic surgeries during the hospital stay have yet to be examined. the main objective of this study is to perform a comparative effectiveness review examining the benefits and harms associated with venous thromboembolism prophylaxis in patients undergoing orthopedic surgeries. it is around efficacy and safety evaluation of using anticoagulant for thromboprophylaxis in patients undergoing orthopedic surgeries taking into the account the reliable selection of patients most benefit. the aims of this study is to analyze patient records in teaching hospitals database of our country (including: hanoi medical university, bach mai hospital, cho ray hospital, viet duc university hospital) and compare the outcomes and costs between different types of anticoagulant medications that were prescribed for the prevention of vte following orthopedic surgeries. this analysis will assess and quantify the outcomes, resource utilization, and cost of care for patients receiving rivaroxaban or enoxaparin. the outcomes of interest include the occurence of dvt and pe, rates of major bleeds, medical resource utilization, and total costs (medical plus pharmacy).


Eligibility criteria:
inclusion criteria: * undergo orthopedic surgery * thromboprophylaxis decision taken * at least 18 years of age exclusion criteria: * planned intermittent pneumatic compression * a requirement for anticoagulant therapy that could not be stopped * severe hypersensitivity reaction (eg, anaphylaxis) to rivaroxaban or enoxaparin. * received another anticoagulant for more than 24 hours * active bleeding or a high risk of bleeding * thrombocytopenia associated with a positive test for antiplatelet antibody. * warfarin associated international normalized ratio (inr) more than 1.5 on the day of the surgery * conditions preventing bilateral venography * intensive care unit (icu) stay after surgery * pregnant or breast-feeding * creatinine clearance less than 30 ml per minute or acute renal failure before the surgery or at any point during the study period. * moderate or severe (child pugh b or c) hepatic impairment or in patients with any hepatic disease associated with coagulopathy. * concomitant use of drugs that are both p--glycoprotein inhibitors and moderate to strong cyp3a4 (ketoconazole, itraconazole, lopinavir/ritonavir, ritonavir, indinavir/ritonavir \& conivaptan) * creatinine clearance (crcl) 15 to 80 ml/min and concurrent use of p-glycoprotein inhibitors or moderate cyp3a4 inhibitors (eg, abiraterone acetate, diltiazem, dronedarone, erythromycin, verapamil)
prospective clinical and virological analysis of healthcare workers diagnosed positive for covid-19.

Conditions: Covid19

Summary: coronavirus disease 2019 (covid-19) is an acute infection of the respiratory tract that emerged in late 2019. in several studies, the cardinal signs of covid-19 associated fever, cough, sputum and dyspnea occurring in the first days of infection. in addition, myalgia was frequent (14.9-32.3%) and digestive signs which may be inaugural were also reported, such as diarrhea (3.8-5%) and nausea/vomiting (4-5%). an increase in medical consultations for anosmia and ageusia without nasal obstruction has also been reported in the context of the covid-19. mild or non-existent symptoms, but also serious forms leading to death or a long stay in intensive care, within a few months, the multiple clinical signs of sars-cov-2 infection were identified. but, beyond the acute symptoms, doctors and patients are discovering a whole range of disorders occurring more distantly, in hospitalized patients or not. in this context of an emerging viral infection such as sars-cov-2, many unknowns are still present such as the duration of symptoms or post-infectious sequelae in patients.

the scientific and medical world is mobilizing to accelerate the production of knowledge on this virus, on the disease it causes as well as the means of curing and preventing it. but no one yet knows how much it can cause immunological changes in the body. for some specialists, this virus is even much more than a viral infection and causes a general disruption of the immune system. faced with the covid-19 pandemic, healthcare workers are a particularly exposed. the main objective of this research is to assess the presence of symptoms attributed to covid-19 at least 6 months after infection confirmed by rt-pcr test of healthcare workers.

Eligibility criteria:
inclusion criteria: * healthcare workers over 18 years of age * healthcare workers who had a diagnosis confirmed by a nasopharyngeal rt-pcr test with sars-cov-2 * healthcare workers with signed consent exclusion criteria: * protected healthcare workers * pregnant or breastfeeding woman
efficacy and safety of semaglutide once-weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia, europe and the united states of america (usa). the aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: - male or female, age at least 18 years at the time of signing inform consent. for japan: male or female, age at least 20 years at the time of signing informed consent - subjects diagnosed with t2dm (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 iu/kg/day and/or 20 iu/day of: insulin glargine, insulin detemir, insulin degludec and/or nph insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - hba1c (glycosylated haemoglobin) 7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive exclusion criteria: - female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). germany: only highly effective methods of birth control are accepted (ie one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. japan: adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. an exception is short-term treatment (7 days or less in total) with bolus insulin in connection with intercurrent illness - experienced more than 3 episodes of severe hypoglycaemia within 6 months prior to screening, and/or hypoglycaemia unawareness - history of pancreatitis (acute or chronic) - screening calcitonin value above or equal to 50 ng/l (pg/ml) - personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome 2 (men 2) - severe renal impairment defined as egfr (estimated glomerular filtration rate) below 30 ml/min/1.73 m\^2 per modification of diet in renal disease (mdrd) formula (4 variable version) - acute coronary or cerebrovascular event within 90 days before randomisation - heart failure, new york heart association (nyha) class iv
outcome of pulpotomy versus root canal therapy

Conditions: Caries; Pulpitis - Irreversible

Summary: root canal therapy (rct) is indicated once the pulp is diagnosed with irreversible pulpitis. despite favorable success rate reported for rct in vital cases, it is time consuming, and might increases fracture susceptibility of teeth. with the advancement of materials and better understanding of pulpal healing, vital pulp therapy is practiced as an alternative treatment with high success rate. the aim of this study is to explore the outcome, quality of life and patient satisfaction after full pulpotomy compared to rct.

permanent molar teeth with carious pulp exposure and mature roots as evident on the preoperative periapical radiograph will be included in the study. the teeth will be randomly divided into 2 groups (n=30). the first group will be treated with biodentine full pulpotomy and the second group will be endodontically treated. based on a previously validated questionnaire. the quality of life and satisfaction of patients after pulpotomy treatment will be evaluated compared to those after endodontic treatment. clinical and radiographic assessment of the treated teeth will be done 3, 6 and 12 months postoperatively. pain level will be recorded preoperatively and 1, 2, 3, 5 and 7 days after treatment. the questionnaire consists of five components: 1. characteristics of the patient; including age, gender, socioeconomic status, smoking, oral hygiene practices, frequency of dental visits, and dental history. 2. postoperative complications including postoperative pain, discomfort,or swelling. these symptoms will be evaluated after 1, 2, 3,5 and 7 days by contacting the patient on the phone and at follow up visits at 3, 6, and 12 months. 3. quality of life instruments designed 4. semantic scales designed to evaluate patient satisfaction with the treatment received. clinical and radiographic assessment of the treated teeth will be recorded. success will be defined as clinically asymptomatic tooth with no sinus tract or swelling or periapical lesion. data will be analysed statistically using appropriate tests based on the distribution of the results.

Eligibility criteria:
inclusion criteria: * medically fit patient * mature permanent tooth with deep caries * diagnosis of irreversible pulpits. * tooth is restored with a direct restoration exclusion criteria: * immature teeth * teeth were hemostasis cannot be achieved after pulpotomy * necrotic teeth * lack of response to cold test
study to evaluate the efficacy and safety of camrelizumab and famitinib in patients with advanced solid tumor

Conditions: Solid Tumor

Summary: this is an open-label, multi-center study to evaluate the anti-tumor activity and safety of camrelizumab combined famitinib in subjects with selected advanced solid tumor.


Eligibility criteria:
inclusion criteria: 1. histologically- or cytologically-confirmed diagnosis of advanced solid tumor. 2. willing to provide tumor tissue for pd-l1 biomarker analysis. 3. at least one measurable lesion according to recist 1.1. 4. ecog performance status of 0 to 1. 5. life expectancy of more than 12 weeks. 6. signing the informed consent forms. 7. adequate bone marrow, liver and renal function. exclusion criteria: 1. subjects with untreated central nervous system (cns) metastases. 2. subjects with an active, known or suspected autoimmune disease. 3. subjects with clinically significant cardiovascular and cerebrovascular diseases. 4. subjects with high blood pressure who cannot be controlled well with antihypertensive drugs. 5. subjects with previous digestive tract bleeding history within 3 months or evident gastrointestinal bleeding tendency. 6. subjects with arterial / venous thrombosis events occurred within 6 months of the first dose. 7. subjects who have previously received anti-pd-1 / pd-l1 monoclonal antibody, anti-ctla-4 monoclonal antibody, and vegfr small molecule inhibitor therapy.