Kornimate/medical-research-clean huggingface dataset:
a study of select drug combinations in adult patients with advanced/metastatic braf v600 colorectal cancer

Conditions: BRAF V600 Colorectal Cancer

Summary: a phase ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.

this is a phase ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic braf v600 (e, d, or k) in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies. the open platform design of this study is adaptive to allow removal of combination treatment arm(s) based on emerging data and facilitate introduction of new candidate combinations. the study is comprised of a dose escalation part and may be followed by a dose expansion part for any combination treatment arm.

Eligibility criteria:
key inclusion criteria: * patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. exceptions may be considered after documented discussion with novartis. * all patients must have a braf v600 mutation confirmed by local assessment. * patients with unresectable advanced/metastatic braf v600 cancer of the colon or rectum with measurable disease as determined by recist v1.1 * patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease key exclusion criteria: * has a known additional malignancy that is progressing or requires active treatment. exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy * impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs * history of or current evidence/risk of retinal verin occlusion or serous retinopathy * history of or current interstitial lung disease or non-infectious pneumonitis * patients with a known history of testing positive for hiv * clinically significant cardiac disease at screening * any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. * pregnant or lactating women other protocol-defined inclusion/exclusion may apply.

Keywords: phase ib, braf-mutated, braf v600e, braf v600d, braf v600k, colorectal cancer, colon cancer, rectal cancer, metastatic, blrm with ewoc
reduction in infarct size by remote per-postconditioning in patients with st-elevation myocardial infarction

Conditions: Coronary Artery Disease; Myocardial Infarction

Summary: * trial objective: to test the hypothesis that remote per-postconditioning in connection with primary pci will reduce myocardial infarct size patients with stemi. * trial design: placebo controlled randomized study with parallel groups * primary endpoint: myocardial infarct size expressed as a percentage of the myocardium at risk determined by cardiac magnetic resonance (cmr) day 4-7 * efficacy parameters: myocardial infarct size expressed as a percentage to the myocardium at risk determined by cmr at 6 months. * global left ventricular function determined by left ventricular ejection fraction determined by cmr. * microvascular obstruction determined by cmr day 4-7. quantified ecv (extracellular volume) in left ventricular as myocardium at risk day 4-7 and remodelling parameters day 180. * safety parameters: major adverse cardiovascular events.

see above. 3 patients left to include.

Eligibility criteria:
inclusion criteria: * patient planned for primary pci. * chest pain indicating myocardial ischemia with a duration \>30 minutes and \< 6 hours prior to randomization. * st elevations \>0.1 mv (\>0.2 mv in v2-v3) in \> two contiguous leads in v1-v6. * informed consent. exclusion criteria: * previous myocardial infarction based on medical history or q-wave on ecg in other area * left bundle branch block on ecg. * previous cabg * cardiac arrest * any contraindication for cmr. * clinical symptoms of claudication * treatment with glibenclamide or cyclosporine on admission. * any condition that may interfere with the possibility for the patient to comply with or complete the study protocol.
blood gas and bleeding disorders in healthy volunteers exposed to nitroglycerin and nitrogen compounds

Conditions: Disorder of Blood Gas; Bleeding Disorder

Summary: the aim of the study was to investigate the possible relationship about blood gas and bleeding disorders in healthy volunteers of blasters and no blasters groups of the italian national mountain and cave rescue who handled nitrogen compounds and nitroglycerine and then they were exposed to combustion products from an accidental uncontrolled detonation of micro-charges during a cave unblocking procedure.

this was a field report of clinical data collected during an accidental uncontrolled detonation of micro-charges, while the cave unblocking procedure was performed by volunteers of blaster group and non blasters group of the italian national mountain and cave rescue, in a cave in trieste (italy; altitude entrance: 348 meters above sea level; total length: 413,5 meters; total depth of 307 meters). before going into the cave (time 0), the following clinical data were collected: age, sex, body mass index; smoke (yes/no), heart rate, arterial blood pressure (mean arterial pressure), oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures. after the accidental uncontrolled detonation of micro-charges, (time 1) heart rate, arterial blood pressure, oxygen saturation measured with pulse oxymetry, epitympanic temperature, blood gases analyses and the haemostasis measures were recorded in each volunteers.

Eligibility criteria:
inclusion criteria: * healthy volunteers of italian national mountain and cave rescue exclusion criteria: * gas exchange disorders * quantitative abnormalities of coagulation assessment * qualitative abnormalities of coagulation assessment

Keywords: arterial blood gas coagulation nitrogen compounds
safety study of oral vinorelbine in subjects with non-hematologic malignancies

Conditions: Nonhematologic Malignancies

Summary: the purpose of this study is to determine the safety of oral administration of vinorelbine once daily for at least 7 days. the study will be conducted in subjects with a non-hematologic malignancy for which there are no currently accepted therapies.


Eligibility criteria:
inclusion criteria: * capable of understanding study requirements and able to provide informed consent * diagnosed with a non-hematologic malignancy for which there are no currently accepted therapies * life expectancy at least 3 months * agreement to use medically acceptable contraception throughout the study * willing and able to comply with the protocol requirements exclusion criteria: * currently receiving systemic treatment for malignancy * not yet recovered from the toxicity of prior therapies * platelet count \< 100,000 cells/mm3 within 7 days prior to study entry * anc \< 1500 cells/mm3 within 7 days prior to study entry * hemoglobin \< 8.5 g/dl within 7 days prior to study entry * ast and/or alt \> 2.5 x uln within 7 days prior to study entry * total bilirubin \> 1.5 x uln within 7 days prior to study entry * creatinine clearance \< 60 ml/min (cockroft-gault formula) within 7 days prior to study entry * receipt of any investigational therapy within 3 weeks prior to study entry * known history of hiv, hbv, and/or hcv infection * clinically relevant active infection or serious co-morbid medical condition at study entry * major surgery within 4 weeks prior to study entry * other malignancy within 3 year prior to study entry * pregnant or breast-feeding * presence of a concomitant disease or condition which, in the opinion of the investigator, could interfere with the conduct of the study or could put the subject at unacceptable risk

Keywords: vinorelbine metronomic dosing oral administration nonhematologic malignancies pharmacokinetics
study of ot-551 eye drops to prevent or delay progression of nuclear cataracts following vitreous removal

Conditions: Epiretinal Membrane; Macular Hole

Summary: the purpose of this trial is to compare the ability of two doses of ot-551 ophthalmic solution and drug-free solution to safely and effectively prevent or delay the progression of nuclear cataracts that frequently develop as a result of vitrectomy (surgery for retina repair), thereby avoiding the need for a second surgery (cataract removal). victrectomies involve removal of the jelly-like substance (vitreous) that is located in a cavity behind the lens.


Eligibility criteria:
inclusion criteria: * imminent vitrectomy to repair macular holes or puckers * ability to be screened for eligibility and begin dosing 7-10 days in advance of the surgery * best corrected etdrs visual acuity equivalent to snellen 20/400 or better in the surgical eye and 20/100 or better in the fellow eye exclusion criteria: * artificial lens or no lens in the surgical eye * cataract (greater than slight opacity or thickness) in the surgical eye * any other retinal abnormality which may be vision-threatening * serious heart, kidney, or liver disease * recent ophthalmic surgery (within 6 months) or ocular infection (within 30 days) * poorly controlled diabetes or unstable glaucoma
post marketing study to evaluate the nimbus device

Conditions: Cerebral Stroke

Summary: a post-market study evaluating the nimbus device in acute ischemic stroke patients with confirmed intracranial large vessel occlusion.

the objective of this study is to assess the efficacy of the nimbus device. the study will also report on clot characteristics and clinical outcomes.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * the subject or the subject's legally authorized representative has signed and dated an informed consent form. * patient has had one or two passes of another mechanical thrombectomy device without achieving mtici 2b or better and continues to have angiographic confirmation of a large vessel occlusion (lvo) in the same vessel. * mrs 0-1 prior to this stroke. * nimbus is used on the second or third overall pass to attempt revascularization. exclusion criteria: * currently participating in an investigational (drug, device, etc.) clinical trial that may confound study endpoints. patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible. * confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication). * all patients with severe hypertension on presentation (sbp \> 220 mmhg and/or dbp \> 120 mm hg). all patients, in whom intravenous therapy with blood pressure medications is indicated, with hypertension that remains severe and sustained despite intravenous antihypertensive therapy (sbp \>185 mmhg and/ or dbp \>110 mmhg). * known cerebral vasculitis. * known cancer with life expectancy less than 12 months. * stenosis, or any occlusion, in a proximal vessel that requires treatment or prevents access to the site of occlusion. * intracranial stenosis that prevents access to the site of occlusion. * computed tomography (ct) or magnetic resonance imaging (mri) evidence of recent/ fresh hemorrhage on presentation. * baseline computed tomography (ct) or mri showing mass effect or intracranial tumor (except small meningioma). * evidence of dissection in the extra or intracranial cerebral arteries. * occlusions in multiple vascular territories (e.g., bilateral anterior circulation, or anterior/posterior circulation).
expanded access study for the treatment of patients with commercially out-of-specification axicabtagene ciloleucel

Conditions: Large B-cell Lymphoma; Follicular Lymphoma

Summary: the goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.


Eligibility criteria:
inclusion criteria: * have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet kite clinical trial release criteria * females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential) * deemed medically fit and stable to receive the product per the investigator's evaluation * repeat leukapheresis is not feasible per the investigator's assessment * be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release * in the investigator's opinion, there is no satisfactory alternative therapy available to the individual exclusion criteria: * history of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel * uncontrolled active infection or inflammation per physician assessment * primary central nervous system lymphoma
characteristics of patients treated with secukinumab for moderate to severe plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this study was a non-interventional, retrospective study collecting data from hospital medical records. approximately 200 adult patients with moderate to severe plaque psoriasis who were treated with secukinumab from hospitals in thailand that participated in this study were expected for data collection.

the study was performed in 7 study sites in thailand and planned to involve approximately 200 medical records. at each study site, patients who were treated with secukinumab or had ever been treated with secukinumab for moderate to severe plaque psoriasis were included for screening by chronological order starting from the most recent date (april 2021) to september 2017. this was to include the most recent clinical practice in the study. the data of patients diagnosed with moderate-to-severe chronic plaque-type psoriasis who received secukinumab in real clinical practice at least 1 dose were collected. the medical records were reviewed to collect the data from the date of the first diagnosis of psoriasis till the most recent dose of secukinumab. the data of secukinumab use and clinical outcome (pasi score) were collected at 4 and 16 weeks after first dose initiation and at the most recent dose of secukinumab. the total number of secukinumab injections at the 3-time points were collected. an index date was defined for each patient. the first secukinumab injection observed in the medical records was considered the index date for the exploratory endpoint.

Eligibility criteria:
inclusion criteria: * adult male or female aged ≥ 18 years at index date * previous diagnosis of moderate to severe plaque psoriasis as hospital record with available baseline pasi at index date (date 0 to date -7 prior index date) * initiated treatment with secukinumab for moderate to severe plaque psoriasis during september 2017-april 2021 exclusion criteria: - patients diagnosed with other forms of psoriasis other than plaque-type

Keywords: secukinumab, psoriasis, effectiveness, real-world, thailand
blitz heart failure

Conditions: Heart Failure

Summary: to evaluate if italian cardiologists are treating heart failure (hf) patients according to international guidelines and if a structured educational program can improved their adherence.

multicentre, cross-sectional, prospective, non-interventional, observational study designed to evaluate the level of adherence to current esc guidelines recommendations in both acute and chronic hf patients enrolled in each participating center and to verify if a specific hf educational intervention composed by an educational web based program of data collection and face to face meetings is able to improve adherence to guidelines recommendations evaluated during a second enrollment period.

Eligibility criteria:
inclusion criteria: * all consecutive patients with chronic hf and those admitted for acute (de novo) or worsening chronic hf. * chronic hf: any nyha class (i-iv). * acute hf only patients in nyha class iii or iv, or with pulmonary edema or cardiogenic shock for whom an iv therapy specific for hf (diuretic, vasodilators, vasopressors) is administered. * any gender. * any etiology of hf. * any level of ef. * written informed consent. exclusion criteria: * - age \<18 years. * inclusion in registries or trials that can influence, by protocol, the clinical management of patients. * patients already enrolled in the blitz hf (by another participating centre or in the first enrollment period).

Keywords: acute heart failure chronic heart failure guideline adherence clinical registry
losartan intervention for endpoint reduction in hypertension (life) study (0954-133)

Conditions: Hypertension and Left Ventricular Hypertrophy (Thickening of the Main Pumping Chamber of the Heart)

Summary: the life study was conducted from 1995-2001. this study was conducted in 9193 patients with high blood pressure and thickening of the main pumping chamber of the heart. the results showed that after an average treatment time of 4.8 years, treatment that was based on losartan was better than treatment based on atenolol for reducing the risk of having a stroke. the main study results were published in dahlof et al. lancet 2002;359:995-1003.


Eligibility criteria:
inclusion criteria: * age 55 to 80 years * males and females * hypertension (160-200/95-115 mm hg * ecg evidence of left ventricular hypertrophy exclusion criteria: * need for treatment with angiotensin converting enzyme inhibitors, or open- label angiotensin receptor blockers or beta-blockers * myocardial infarction or stroke within 6 months
microcirculatory assessment in patients with trauma and severe burns

Conditions: Burns; Trauma

Summary: predict the development of multiple organ failure in patients with trauma and severe burns.

microvascular alterations are frequently seen in patients with sepsis, trauma, burns and those who are hemodynamically uncompensated(shock). the use of the microscan is a non-invasive approach to visualize and assess impaired mucosal microcirculation in order to identify early on patients who are predisposed for mof (multiple organ failure)

Eligibility criteria:
inclusion criteria: * patients with severe burns/trauma ages 19-80. patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old exclusion criteria: * patients undergoing elective surgery \< 19 years old.

Keywords: trauma multiple organ dysfunction syndrome
assessment of the prescriber's and the pharmacies overview of patient medication by use of the fidelity coefficient.

Conditions: Misuse of Prescription Only Drugs

Summary: the purpose of this study is to twofold. the investigators wish to introduce a new patient-descriptive parameter, the 'fidelity coefficient', and use it to assess and compare the overview of patient's medication possessed by the general practitioners and the pharmacies.

the fidelity coefficient, fc, is a measure of what proportion of individual patients' medication that are accounted for by the most used prescriber and the most used pharmacy. each patient therefore has two values, one describing his fidelity towards his most used prescriber, fcpresc, and one describing his fidelity towards his most used pharmacy, fcpharm. the investigators intend to assess this parameter in an observational population scale database study, using standard descriptive statistics, and subsequently compare the obtained average fcpresc and fcpharm. furthermore, the investigators will analyze the two obtained fcs for dependency of a predefined list of variables: age, gender, number of prescriptions, whether the most frequent prescriber was a gp and whether the most used pharmacy was urban. finally, the investigators intend to analyze which medications (grouped using the atc-system with 4 digits, e.g. c07a) that has the highest proportion of prescriptions that were either issued by a non-main prescriber or redeemed at a non-main pharmacy, which roughly translates into the most 'infidel' medications. to insure relevance we intend to use a cut-off-value of the medication being prescribed at least 50.000 times, which equals about 85 % of the data according to preceding analyses. the data for this study will be obtained from the odense university pharmacoepidemiological database (oped). in brief, it is a research database with full coverage of all reimbursed prescriptions in the region of southern denmark (1.2 million inhabitants). the data included in each prescription record includes the prescription holder, the prescriber, the pharmacy, the date of dispensing and a full account of the dispensed product, including substance, brand name, route of administration, atc-code and defined daily dose (ddd). some drugs are exempt from re-imbursement and thus not covered by the database, including benzodiazepines, oral contraceptives, laxatives and certain antibiotics.

Eligibility criteria:
inclusion criteria: * having filed more than 9 prescriptions during 2009. exclusion criteria: * none

Keywords: prescription, general practitioner, pharmacy
primary prevention of peristomial hernias via parietal prostheses

Conditions: Parastomal Hernia

Summary: the purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.

previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. however, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy "port". our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.

Eligibility criteria:
inclusion criteria: * the patient has given informed consent * the patient must be affiliated with a health insurance programme * the patient must be available for 24 months of follow-up * the patient requires a colostomy (primo-event, ie first colostomies only) exclusion criteria: * the patient is currently participating in another interventional study * the patient is in an exclusion period determined by a previous study * the patient is under guardianship * the patient refuses to sign the consent * it is impossible to communicate information to the patient (does not read french) * the patient is pregnant * the patient is breastfeeding * there is a contra-indication for any treatment used in this study * the subject has already had a colostomy * the subject has peritonitis * the subject needs a colostomy for infectious reasons

Keywords: mesh hernia