Kornimate/medical-research-clean huggingface dataset:
a study of askg712 in patients with neovascular age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: the purpose of the phase 1 study is comprised of single ascending-dose component (part 1) and multiple ascending-dose component (part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of askg712 in patients with neovascular age-related macular degeneration (namd).

the part 1 of study is a multicenter, open-label, sequentially, single ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of askg712 in subjects with namd. the part 2 of study is a multicenter, open-label, sequentially, multiple ascending-dose (3 doses) study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of askg712 in subjects with namd. subjects will be sequentially enrolled into different dose-level cohorts following the "3+3" design to determine the maximum tolerated dose (mtd) or the maximum administered dose has been reached.

Eligibility criteria:
inclusion criteria: * 1. signed the informed consent form; * 2. male or female subjects with 50\~80 years of age; * 3. active sub-foveal or juxta-foveal choroidal neovascularization(cnv) lesions secondary to neovascular age-related macular degeneration(namd); * 4. total lesion area ≤ 12 disc area(da); * 5. bcva letter score measured at screening of 19\~78 letters. exclusion criteria: * 1. history of uveitis in either eye； * 2. current active inflammation or infection in the study eye; * 3. central foveal scar, fibrosis or atrophy of macular in the study eye; * 4. subretinal hemorrhage area in the study eye ≥ 50% of total lesion size; * 5. scar or fibrosis area in study eyes ≥ 50% of total lesion size; * 6. history or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of askg712 or require medical or surgical intervention. * 7. presence of retinal pigment epithelial tear; * 8. previous intraocular operations in the study eye; * 9. uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye; * 10. previous anti-vegf drug treatment within 30 days prior to screening； * 11. diseases that affect intravenous injection and venous blood sampling; * 12. systemic autoimmune diseases; * 13. any uncontrolled clinical disorders; * 14. history of allergy or current allergic response to askg712 or fluorescein; * 15. pregnant or nursing women; * 16. subjects should be excluded in the opinion of investigators.
data acquisition for optimization of coronary artery disease (cad) algorithm

Conditions: Coronary Artery Disease

Summary: the purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (cad, coronary artery disease).

acoustic information from the heart is obtained from patients referred to examination for coronary artery disease. the acoustic signals are evaluated as indicators for cad.

Eligibility criteria:
inclusion criteria: * at least 18 years old * referred to diagnostically ca-ct, ct scan and/or cag examination due to suspicion of coronary artery disease * subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome * subject is willing to adhere to the study procedure * has signed the informed consent form and authorization to registration and publication of health information exclusion criteria: * has acute coronary syndrome or stroke * arterial fibrillation * known severe arrhythmia or resting heart rate above 85 bpm * known diastolic murmurs due to heart valve disease * has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart * reduced ejection fraction \< 50% * inability to understand or adhere to instructions for acoustic data-acquisition (i.e. subject not able to hold breath due to kol or asthma) * inability to perform ct-angio and/or subsequent cag * in active treatment for any cancer * in active treatment for immunosuppression after transplantation * established or pursuing pregnancy or breast feeding * has damaged skin on the spot where the patch is placed during the recordings.

Keywords: cad
use of minocycline in intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: to date, no neuroprotective drugs have demonstrated clinical efficacy in intracerebral hemorrhage (ich). this study will use intravenous (iv) minocycline in ich to evaluate for (1) safety/ tolerability and (2) evaluate for clinical efficacy

intracerebral hemorrhage (ich) remains a devastating neurological disorder with high mortality and poor prognosis with unchanged mortality rates (53-59%). acute treatment options for ich remain supportive with no available effective drug or surgical therapy. all trials so far have failed to improve clinical outcome in randomized, double-blinded trials. however, one area of interest has been maintaining the integrity of the blood-brain-barrier (bbb) and preventing the growth of vasogenic edema. matrix metalloproteinases (mmp) are a family of ubiquitous zinc-dependent endopeptidase enzymes whose primary function is the digestion of collagen type iv, laminin, and fibronectin for the purpose of remodeling extracellular basal lamina. elevated mmp-9 as a pathological process associated with larger hematoma volume, larger perihematomal edema, and poorer clinical outcome in intracerebral hemorrhage is well documented in animal models and patients. one particular mmp-9 inhibitor gaining usage in cerebrovascular disease is minocycline. normally fda-approved for bacterial infection and acne vulgaris, minocycline has also been found to be both a safe and effective treatment in ischemic stroke; its potential role as a neuroprotectant in ischemic stroke is currently being tested in a large, randomized, double-blinded trial. minocycline's beneficial role as a neuroprotectant may also extend to ich. by inhibiting mmp-9, minocycline may decrease bbb permeability, resulting in less perihematomal edema and decreased mass effect. although numerous animal ich models support minocycline's role as an inhibitor of mmp-9 and neuroprotectant, its use has never been studied in humans with ich.

Eligibility criteria:
inclusion criteria: 1. age 18-80 yo 2. acute neurological deficit with corresponding ich noted on head ct 3. glasgow coma scale (gcs) \> 8 4. onset of symptoms within 12 hrs 5. \< 30 ml of blood noted on initial cth (30 ml hematoma volume is a noted independent marker between good and poor clinical outcome) 6. ich score \< 3 7. english/ spanish speaking exclusion criteria: 1. allergy to tetracycline and tetracycline analogues 2. pregnancy or suspected pregnancy 3. hepatic and/or renal insufficiency (lfts 3x greater than upper limit of normal; creatinine \> 2 mg/dl) 4. thrombocytopenia (plt count \< 75,000) 5. history of intolerance to minocycline 6. baseline modified rankin score \> 1 7. stuporous or comatose (gcs \< 8) 8. presence of concomitant serious illness that would confound study, including serious psychiatric disease or prior suicide attempts.
cardiac surgery outcomes in blood-transfusion acceptors and no acceptors

Conditions: Thoracic Surgery; Blood Transfusion; Hemoglobinemia; Cardiac Disease

Summary: the primary objective of this study is to analyze mortality after cardiac surgery in blood-transfusion non-acceptors (btna), and the secondary one to perform an adjusted comparison with a blood-transfusion acceptors (bta) matched cohort.


Eligibility criteria:
inclusion criteria: * patients undergoing heart surgery in our hospital from 2009 to june 2020 exclusion criteria: * preoperative hemoglobin lower than 120g/l * euroscore-ii higher than 20% * heart transplant * assist device implantation * surgery of acute myocardial infarction-derived complications * other emergent cardiac surgeries (acute aortic dissection, heart injuries).
icotinib as an adjuvant therapy for patients with stage iia-iiia adenocarcinoma with egfr mutation

Conditions: Non-small Cell Lung Cancer

Summary: adjuvant therapy has been proved effective in treating earlier stage or less advanced non-small-cell lung cancer. this study is designed to evaluate the efficacy of icotinib as adjuvant therapy in treating stage iia-iiia adenocarcinoma patients with egfr mutation. the primary endpoint is disease-free survival.


Eligibility criteria:
inclusion criteria: * the patients present with operable stage iia-iiia (n0-1) lung adenocarcinoma with 19 or 21 exon mutation * the patients have no history of anti-cancer therapies including chemotherapy, radiation therapy * the patients' eastern cooperative oncology group scores are ≤ 0-1 * the patients signed the written informed consent exclusion criteria: * patients with unresected tumor * wild egfr type * allergic to the study drug * patients have severe non-cancerous diseases * patients are undergoing current administration of anti-cancer therapies, or are attending some other clinical trials
palliative stereotactic radiation for pancreatic or periampullary adenocarcinoma

Conditions: Pancreatic Cancer; Periampullary Adenocarcinoma

Summary: the investigators are looking to see if a certain dose of stereotactic body radiation therapy (sbrt) may be a viable treatment option for recurrent or residual pancreatic or periampullary adenocarcinoma.

no standard treatment option has yet been established for patients with recurrent or residual disease after definitive treatment of pancreatic or periampullary cancers (duodenal, ampullary, bile duct). linac based stereotactic body radiation therapy (sbrt) administered in 1-3 fractions has been shown to be an effective treatment option for patients with unresectable, locally advanced pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. associated late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. we hypothesize that similarly excellent local control rates (80-90% at one year) with a reasonable rate of toxicity (≤20%) can be achieved using linac based sbrt delivered as 5 gy x 5 for patients with local failure (remaining disease) after previous treatment with conventional chemoradiation therapy (crt) with or without surgery and as 6.6 gy x 5 for radiation-naïve patients with local failure (remaining disease) after previous treatment with surgery and/or chemotherapy. the toxicities of note for this trial are grade 2 and greater gastritis, fistula, enteritis, ulcer, or any other grade 3 or greater gastrointestinal toxicity.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * karnofsky performance status greater than or equal to 70% * confirmed pancreatic or periampullary adenocarcinoma * pancreatic or periampullary tumor less than 8.0 cm in greatest axial dimension * either: * standard of care treatment for pancreatic cancer that included radiation therapy \* patients may be receiving continued chemotherapy post initial crt. or * standard of care treatment for pancreatic cancer that did not include radiation therapy \* patients must have attempted chemotherapy upon initial diagnosis * acceptable organ and marrow function as determined by blood tests * ability to understand and give consent * must be a patient to be treated with sbrt only at johns hopkins hospital * life expectancy of greater than 3 months exclusion criteria: * extensive metastatic disease * performance status of less than 70 * children are excluded form the study * no uncontrolled intercurrent illness * no concurrent malignancy other than melanoma * pregnant or breast feeding women are excluded * women who are not post-menopausal and have a positive pregnancy test * life expectancy of less than 3 months

Keywords: recurrent unresectable residual stereotactic body radiation therapy (sbrt) palliative management
long-term safety and clinical outcomes of livmarli in patients in the united states (leap-us)

Conditions: Alagille Syndrome; Progressive Familial Intrahepatic Cholestasis

Summary: the objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with alagille syndrome (algs) or progressive familial intrahepatic cholestasis (pfic) treated with livmarli.

livmarli® is a novel, minimally absorbed, pharmacological product that inhibits the ileal bile acid transporter (ibat) in the terminal ileum, leading to reduced levels of bile acids. livmarli (maralixibat) has been developed by mirum pharmaceuticals and was the first treatment approved by the us food and drug administration (fda) for the treatment of cholestatic pruritus in patients 3 months of age and older with alagille syndrome (algs). subsequently, livmarli was approved by the fda for the treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (pfic). to be eligible for the study, participants must meet the following criteria: * a clinically and/or genetically confirmed algs diagnosis or pfic diagnosis * prescribed livmarli

Eligibility criteria:
inclusion criteria: * a clinically and/or genetically confirmed algs diagnosis or pfic diagnosis * participant prescribed livmarli exclusion criteria: * refusal to provide informed consent/assent (if required by the local irb) * previously or currently on livmarli through participation in a clinical study or expanded access program * participants who have previously received an sbd or lt * any condition or abnormalities that, in the opinion of the investigator, may interfere with the participant participating in or completing the study * participants who have received an investigational drug within 30 days of the first dose of livmarli

Keywords: algs liver diseases pfic livmarli alagille syndrome progressive familial intrahepatic cholestasis
assessment of cognitive functions in bipolar patients

Conditions: Bipolar Disorder

Summary: assessment of cognitive function in manic bipolar patient

assessment of severity of mania and depression in bipolar patients then evaluate their cognitive function.

Eligibility criteria:
inclusion criteria: * aged 18-55 years * of both sex * diagnosed as bipolar by dsm-5(patient) exclusion criteria: * current medical and psychiatric comorbidities which may affect cognitive status. * substance abuse or dependence (except nicotine and caffeine)in last month. * somatic treatment with drugs known to affect cognitive status (cortisol, antihistamines, etc.)
immunological characteristics of covid-19 patients

Conditions: Covid19

Summary: the study will look at the immunological characteristics of covid-19 patients and determine neutralizing antibodies against sars-cov-2 virus.

the immunogram (quantitative tbnk immunophenotipisation) will be performed by flow cytometry, the antibody response will be determined by ivd elisa. clinical biochemical and immunochemical (eclia) tests (including il-6) will be performed on cobas analyzers. hemogram with differential blood picture will be performed with a hematology analyzer sysmex xn 3100, examination of blood smears with cellavision system or. microscope. coagulation tests will be performed on bcs xp analyzers. an in-house system for the analysis of sars-cov-2 virus fusion inhibitors on human cells will be used to detect the ability of antibodies from patients' serum to neutralize the virus and thus potential protection against re-infection. the system is quantitative, meaning that the titer of such antibodies could be determined, and thus the potential level of protection would be evaluated.

Eligibility criteria:
inclusion criteria: provide written consent before being included in the essay. positive cases of covid-19 (based on polymerase chain reaction or positive antigen test for sars-cov-2). exclusion criteria: patients who are unable to give consent or who are unable to follow up will be excluded.

Keywords: covid-19 sars-cov-2 immunology tbnk cells neutralizing antibodies
diagnostic survey of mental and substance use disorders in hunt (psykhunt)

Conditions: Mental Disorders; Substance Use Disorders; Treatment; Participation

Summary: the aims of this observational survey are to i) gather experience on how to conduct a prevalence study of mental disorders in the norwegian setting, ii) collect data on the prevalence, risk factors and consequences of mental and substance use disorders, iii) collect data on treatment coverage for mental and substance use disorders, iv) conduct a thorough nonparticipation analysis.

the psychiatric survey was a sub-project in the fourth wave of the trøndelag health study (hunt4), conducted on hunt4 participants aged 20 to 65 years from the geographical areas nord-trøndelag and the city of trondheim. the targeted sample size was 4,000 participants, and 16,602 persons from the study population of hunt4 participants were invited to reach this goal. the only exclusion criterion was insufficient understanding of norwegian or english. the investigators had complete lists with postal addresses and mobile phone numbers for all eligible participants as well as information about date of birth and gender. potential participants were sampled in repeated probability sampling draws over the course of the data-collection period, which lasted from november 2nd 2018 to september 18th 2020. younger persons were oversampled to adjust for the expected larger nonparticipation among these age-groups. the predesignated participants were informed about the project through postal letters. a week after receipt of the letter, each received an sms with information on how to sign up for the psychiatric interview. one sms reminder was sent to persons who did not respond to the initial invitation. the investigators made four contact attempts to schedule the interview amongst those who registered; three by phone and one final by sms. all participants received a $30 gift card as a token of appreciation. computer assisted face-to-face or telephone interviews were conducted by trained and certified interviewers at local field stations. the world health organization (who) composite international diagnostic interview, fifth version (cidi 5.0) was used as instrument in the data-collection.

Eligibility criteria:
inclusion criteria: * sufficient understanding of norwegian or english to conduct the interview exclusion criteria: * none

Keywords: mental disorders substance use disorders treatment participation
mechanical insufflation-exsufflation in preventing post extubation respiratory failure in patient with critical care neuromyopathy

Conditions: Acute Respiratory Insufficiency; Respiratory Failure

Summary: respiratory failure after extubation is a relevant consequence of poor airway clearance due to respiratory muscle weakness and respiratory failure after extubation and reintubation is associated with increased morbidity and mortality. the study will evaluate the contribution of mechanical insufflation-exsufflation (mi-e) in preventing respiratory failure after extubation as compared manually assisted coughing

critical care neuromyopathy (ccn) occur in 25% of patient in intensive care unit (icu). respiratory failure after extubation is a relevant consequences of poor airway clearance due to respiratory muscle weakness. respiratory failure is a major cause for reintubation which increase severity of illness, this is an independent risk factor for nosocomial pneumonia, increased hospital stay and mortality. currently, respiratory physiotherapy includes, manual expiration assist often associated with nasotracheal aspiration. despite of this care, respiratory failure occur in 30% of patients within 48 after planned extubation. mi-e has been evaluated for neuromuscular disease patient, and increase peak cough flow and the airway clearance. so the beneficials effects of mi-e should be confirmed in a trial in this specific population. we planned to conduct a study evaluating the efficacy of mi-e in the prevention of extubation failure and mortality in these patients. if no signs of respiratory failure appeared after 120 min of a spontaneous breathing trial, patients will be extubated and randomly allocated after extubation to mi-e group or control group. the clinical follow-up will be as follow: the incidence of extubation failure, the reintubation, the icu or 28-day survival,90-day survival, icu length of stay.

Eligibility criteria:
inclusion criteria: * male or female patient aged ≥ 18 years. * patient admitted in participant icu. * patient intubated for 48 hours at least. * patient presenting an icu acquired neuromuscular disorders. exclusion criteria: * respiratory or haemodynamic instability. * patient having a contraindication to use face mask (recent facial surgery, severe craniofacial trauma,...) gastroesophageal surgery. * severe ventricular rhythm disorders. * patient with tracheotomy. * uncontrollable vomiting. * severe sepsis. * upper airway disorders. * upper gastrointestinal bleeding. * any decision to limit therapeutic effort in the icu. * patient with limit therapeutic effort in the icu with unsuccessful spontaneous respiratory trial.

Keywords: intensive care unit acute respiratory insufficiency respiratory failure mechanical insufflation-exsufflation