Kornimate/medical-research-clean huggingface dataset:
renal allograft tolerance through mixed chimerism (belatacept)

Conditions: Kidney Failure, Chronic; Renal Insufficiency

Summary: this study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a haplo-identical related donor. an investigational medication and other treatments will be given prior to and after the transplant to help protect the transplanted kidney from being attacked by the body's immune system


Eligibility criteria:
inclusion criteria: * male or female 18-60 years of age * candidate for a living-donor renal allograft from an hla mismatched donor * first or second transplant with either a living donor or cadaveric transplant as the first transplant. * use of fda-approved methods of contraception by all recipients from the time that study treatment begins until 104 weeks (24 months) after renal transplantation. * ability to understand and provide informed consent. * serologic evidence of prior exposure to ebv. exclusion criteria: * abo blood group-incompatible renal allograft. * evidence of anti-hla antibody within 60 days prior to transplant as assessed by routine methodology (ahg and/or elisa) * leukopenia or thrombocytopenia. * positive for hiv-1, hepatitis b core antigen, or hepatitis c virus; or positivity for hepatitis b surface antigen. * cardiac ejection fraction \< 40% or clinical evidence of insufficiency. * forced expiratory volume fev1 \< 50% of predicted. * lactation or pregnancy. * history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix. * underlying renal disease etiology with a high risk of disease recurrence in the transplanted kidney (such as focal segmental glomerulosclerosis, type i or ii membranoprolifertive glomerulonephritis). * prior dose-limiting radiation therapy. * known genetic disease or family history that may result in greater sensitivity to the effects of irradiation, or a physical deformity that would preclude adequate shielding or appropriate dosing during the irradiation component of the conditioning regimen. * enrollment in other investigational drug studies within 30 days prior to enrollment. * abnormal (\>2 times lab normal) values for (a) liver function chemistries (alt, ast, ap), (b) bilirubin, (c) coagulation studies (pt, ptt). * allergy or sensitivity to any component of belatacept, atg, tacrolimus, or rituximab. * maintenance immunosuppression within 3 months prior to conditioning other than physiological doses of steroids, defined as ≤ 50 mg of hydrocortisone or dose equivalent. * the presence of any medical condition that the investigator deems incompatible with participation in the trial.

Keywords: esrd
use of prothrombin complex concentrate in patients admitted in emergency care units for severe bleeding while receiving oral anticoagulants

Conditions: Emergency Care for Severe Bleeding While on Anticoagulants

Summary: the study is assessing the impact of an expert ecrf on the management of severe bleeding in the administration of prothrombin complex concentrate in patients treated with oral anticoagulants and adherence to recommendations or experts' consensus


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) * receiving oral anticoagulants (vka or doac) * with a severe bleeding episode meeting at least one of the following criteria * external hemorrhage which cannot be controlled by usual means or * hemodynamic instability: sbp \< 90 mmhg or sbp decrease * 40 mmhg from usual sbp or mean bp \< 65 mmhg or any sign of shock or * patient requiring a hemostatic procedure in emergency: surgery, interventional radiology, endoscopy or * need for transfusion of packed red blood cells or * hemorrhage jeopardizing the vital or functional prognosis: e.g. intracranial hemorrhage, intraspinal hemorrhage, intraocular or retro-ocular hemorrhage, hemothorax, hemoperitoneum, retroperitoneal hemorrhage, hemopericardium, deep muscle hematoma or compartment syndrome, acute digestive hemorrhage, hemarthrosis. * admitted in the participating emergency service * accepting the collection of his/her own health-related data exclusion criteria: * patient participating in another interventional study * pregnant or nursing woman * patient under supervision or legal guardianship
a first-in-human study of jab-3068 (shp2 inhibitor) in adult patients with advanced solid tumors in china

Conditions: Non-small Cell Lung Cancer; Head and Neck Cancer; Esophageal Cancer; Other Metastatic Solid Tumors

Summary: this is a phase 1/2a, open-label, multi-center study of jab-3068 in patients with advanced solid tumors.this study has two phases: dose escalation phase and dose expansion phase.

dose escalation study phase is designed to determine the maximum tolerated dose (mtd) according to a 3+3 design and recommended phase ii dose (rp2d) and to characterize the safety, tolerability, and pharmacokinetics (pk) profile of jab-3068. other dose regimens may be explored based on the analysis of emerging pk and safety data. at this study phase, jab-3068 dministered orally once daily (qd) or twice daily (bid) or once every other day (qod) in 28-day treatment cycles to adult patients with advanced solid tumors, dose expansion study phase is designed to evaluate the antitumor activity(orr and dor) of jab-3068 in patients with nsclc, escc and hnscc.

Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to any study-related procedure being performed; 2. age 18 years or older; 3. dose escalation(phase i): patients with histologically or cytologically confirmed, advanced solid tumors (including lymphoma) which have progressed from standard therapy or for whom no standard therapy exists; dose expansion(phase iia ): patients with histologically or cytologically confirmed, advanced nsclc, escc, hnscc which have progressed from standard therapy; 4. patients with life expectancy ≥3 months; 5. dose expansion(phase iia ): patients have available archival tissue can be provided or willing to perform biopsy to provide fresh tumor tissue. 6. patients with other solid tumors must have at least one measurable lesion as defined by recist v1.1;patients with lymphomas must have at least one measurable lesion as defined by iwg 2007 criteria; 7. eastern cooperative oncology group performance score 0 or 1; 8. patients who have sufficient baseline organ function. exclusion criteria: 1. patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment; 2. history or current evidence of retinal vein occlusion (rvo) or current risk factors for rvo; 3. lymphoma with brain metastasis; other solid tumors:known malignant central nervous system (cns) disease other than neurologically stable, treated brain metastases; 4. active infection including hepatitis b, hepatitis c and human immunodeficiency virus (hiv) 5. patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator and sponsor, could affect the patient's participation in the study 6. patients who have impaired cardiac function or clinically significant cardiac diseases 7. use of anti-cancer treatment drug ≤21 days prior to the first dose of jab-3068. 8. use of an investigational drug during the past 30 days prior to the first dose of jab-3068.

Keywords: jab-3068 shp2 ptpn11 escc nsclc hnscc colorectal cancer (crc) egfr
acoustic pharyngometry in obstructive sleep apnea syndrome patients, with indication of continuous positive air pressure

Conditions: Obstructive Sleep Apnea Syndrome

Summary: acoustic pharyngometry (ap) is a method of measurement of transversal sectional areas (tsa) and volumes of oral cavity and pharynx, based on acoustic waves. the aim of this study is to describe changes on oropharynx dimensions caused by cpap (continuous positive air pressure) in patients with severe obstructive sleep apnea syndrome when compared with patients with primary snore, using ap. the exam will be made during the use of cpap, at various pressures. the investigators also intend to determine if pressure determined by polysomnography in osas patients cause some type of different change in ap graphic.

the investigators are performing ap exams in severe apneics (cases) and primary snorers (control group),first basal, and then at the same time of using cpap with a nasal mask, at progressive pressures (from 4 to 10 cmh20 in snorers, and until 2 pressures above the polysomnography determined pressure in apneics). the wave tube of pharyngometer is connected to the patient´s mouth by a mouthpiece, and to the computer. it makes a graphic of area x distance for each measurement. then the investigators compare the changes in area, distance and volume of oral cavity and pharynx, determined by cpap pressures, in both groups, and compare the measurements inside each group and between the two groups. finally, the investigators analyse the cpap pressure that most modifies the ap graphic, observing if it has some relationship with the polysomnography determined cpap pressure. the investigators intend this way to show the kind of modifies determined by cpap in oral cavity and oropharynx and, secondarily, observe some relationship of ap and polysomnography in determine the cpap ideal pressure for severe apneic patients.

Eligibility criteria:
inclusion criteria: * age: 18 - 65 years old * female and male exclusion criteria: * cardiopathies * chronic nasal obstruction * using neurologic or psychiatric drugs

Keywords: acoustic pharyngometry cpap obstructive sleep apnea syndrome
genomic investigation of unusual responders

Conditions: Cancer; Breast Cancer; Non-small Cell Lung Cancer; Colorectal Cancer; Genitourinary Cancer; Gynecological Cancer; Upper Aerodigestive Tract Cancer; Pancreatobiliary Gastrointestinal Cancer; Melanoma (Skin); Rare Cancer; Carcinoma of Unknown Primary

Summary: studies have shown that tumors from the same patient may respond very differently to the same therapeutic agents. this study aims to investigate the genetic basis of tumors that respond abnormally well or poorly to therapeutic agents in an effort to understand the fundamental genetic basis of this response. the present protocol seeks to retrospectively perform exome, next-generation (dna) sequencing and/or other molecular techniques on tumor samples to identify the genetic basis of a patient's exceptional response to chemotherapy.


Eligibility criteria:
inclusion criteria: 1. the patient must have either an exceptionally good or poor response to treatment, as indicated by their treating physician. 1. the exact definition of this is adaptable to the disease but a suggested guideline is a complete response, partial response or progression free interval of at least 6 months 2. exceptionally poor response includes patients who were expected to respond favourably to a treatment but instead responded poorly (e.g dramatic tumor growth or death) 2. the patient must have sufficient archival tumor available for sequencing. 3. deceased patients will also be considered for analysis (up to 30 patients per year) if they meet at least one of the following requirements: a)) patients who have archival tissue stored within the uhn laboratory medicine program who have had a consent waiver granted by the reb to access the tissue. b) patients who have archival tissue banked for further research within the uhn biospecimen sciences program exclusion criteria: * none

Keywords: cancer breast cancer non- small cell lung cancer colorectal cancer genitourinary cancer gynecological cancer upper aerodigestive tract cancer pancreatobiliary gastrointestinal cancer melanoma cancer rare cancer unknown primary cancer
painless sharp wound debridement with lidocaine-23%-tetra-caine-7% gel versus emla 5% cream

Conditions: Ulcus Cruris; Ecthyma; Ulcer, Leg; Ulcer Venous

Summary: in a single-blind, crossover, randomized, controlled trial with 40 participants we aim to demonstrate superior anaesthetic efficacy of lidocaine-23%-tetracaine-7% (imp2) gel over emla 5% cream (imp1) at comparable safety in sharp wound debridement of chronic leg ulcers. this is a monocentric investigator initiated trial conducted in the university hospital zurich. in this longitudinal trial, participants receive a sequence of different treatments (treatments on different days) and therefore are randomly assigned to one of two treatment sequences. one-half of participants will first receive imp1 (first treatment visit, randomized) and then imp2 (second treatment visit, crossover); the other half of participants the reverse sequence (first treatment visit: imp2, second treatment visit: imp1). primary objective: we want to show that imp 2 (lidocaine-23%-tetracaine-7% gel) is more effective in pain reduction than imp 1 (emla® 5% cream) in sharp wound debridement.


Eligibility criteria:
inclusion criteria: * participants between 18 years and 90 years * chronic leg ulcer(s) (duration \> 4 weeks) with biofilm or necrotic layers which require consecutive sharp debridement for at least two times (of the same ulcer) * minimal ulcer area of 1 cm2 * leg ulcer has to enter into one of the following well defined aetiologies: venous, mixed venous-arterial, arterial, hypertensive ischemic leg ulcer (martorell), vasculitic, ecthyma (covering \>90% of all observed leg ulcers) * informed consent as documented by signature and being able to follow the study protocol (cognition) * proficiency in german, oral and written information exclusion criteria: * women who are pregnant or breastfeeding (women of childbearing potential need to perform a pregnancy test (urine test) within 24 hours prior to the study intervention and need at least one simple acceptable contraceptive method) * participants with hypersensitivity or allergy to lidocaine, prilocaine, tetracaine or auxiliary supplies contained in either emla® 5% cream or lidocaine-23%-tetracaine-7% gel. * participants with peripheral neuropathy (over 4/10 insensitive points with semmes monofilament) are excluded due to disturbed pain perception, which could potentially influence the results. * participants that were previously included in this clinical trial * participants with a total wound area larger than 200 cm2

Keywords: emla lidocain tetracain leg ulcer sharp wound debridement anesthesia
treatment with adenosine diphosphate (adp) receptor inhibitors: longitudinal assessment of treatment patterns and events after acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the treatment with adp receptor inhibitors: longitudinal assessment of treatment patterns and events after acute coronary syndrome (translate-acs) study is a prospective, observational longitudinal study to evaluate the real world effectiveness and use of prasugrel and other adp receptor inhibitor therapies among myocardial infarction (mi) participants treated with percutaneous coronary intervention (pci) during the index hospitalization. participant management and treatment decisions are at the discretion of the care team per routine clinical practice. approximately 17,000 participants will be enrolled at approximately 350 sites in the united states. follow-up will be conducted through 15 months in approximately 15,650 participants. translate-acs will complement the results of both randomized controlled clinical trials and current registries in addressing the real world treatment patterns and clinical outcomes for mi participants managed with pci and initiated on adp receptor inhibitor therapy. in addition to determining the effectiveness of prasugrel in comparison to other adp receptor inhibitors, the study will also determine factors associated with initial adp receptor inhibitor selection and longitudinal patterns of use, evaluate the safety, and describe and compare resource use and medical costs associated with adp receptor inhibitors. additionally, this study will generate a continuum of information from the inpatient to outpatient settings to provide a comprehensive picture of participant treatment and outcomes not currently available for novel adp receptor inhibitors.


Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age * diagnosed with nstemi or stemi treated with a pci during the index hospitalization * initiated (or continued) on adp receptor inhibitor therapy before discharge * fully informed and are able to provide written consent for longitudinal follow-up and data collection exclusion criteria: * simultaneously participating in a research study that directs choice of either an investigational or approved adp receptor inhibitor within the first 12 months after mi
3m cavilon advanced skin protectant for the prophylaxis of radiation dermatitis

Conditions: Radiation Dermatitis

Summary: this study observes a liquid skin protectant that is a polymeric-cyanoacrylate solution designed to protect intact or damaged skin due to radiation.


Eligibility criteria:
inclusion criteria: * age ≥ 18years. * patient has initial or recurrent disease * undergoing external beam radiotherapy at the mayo clinic rochester campus note: patients who are undergoing concurrent chemotherapy are eligible * ability to complete questionnaire(s) by themselves or with assistance * provide informed written consent * willing to consent for photography of radiation field * available to return to mayo clinic in within 1 week post treatment for assessment (+/- 7 days). * at risk for developing ≥ grade 2 dermatitis radiation as determined by treating radiation oncology clinician * biologic effective dose of \>42 gy10 as calculated using the web site eqd2.com. exclusion criteria: * unable to provide informed consent * patients with active rash, pre-existing dermatitis, lupus or scleroderma within the treatment area that may make skin assessment for the study difficult * known history of developing an allergic reaction after using a product containing cyanoacrylate or acrylates * subject has a medical condition that in the opinion of the investigator should exclude him/her from participating in the study * subject has been enrolled in an investigational study where product was applied to the proposed study site within 30 days of the screening visit * the skin area affected by radiation requires treatment with a concomitant medication or product (if applicable)
ocular biometrics in a french population

Conditions: Cataract

Summary: the investigators aimed to study ocular biometrics parameters and their association with age, gender and the prevalence of high myopia in a population of cataract surgery candidates in the south of france. the investigators also aimed to define proportion of an "usual eye" and know the rate of inhomogeneous eyes in our population.


Eligibility criteria:
inclusion criteria: * aged 40 years * olderpatients who underwent ocular biometrics before cataract surgery exclusion criteria: incomplete examination * previous cataract surgery * age \< 40 years

Keywords: biometry axial length cataract gender high myopia
non-routine use of antibiotics (amoxi-light)

Conditions: Severe Acute Malnutrition

Summary: to evaluate, in routine operational settings of treatment of uncomplicated severe acute malnutrition (sam) in children aged 6-59 months, the risk of nutritional recovery and hospitalization with non-routine use of amoxicillin compared to the risk achieved with systematic use of antibiotics.

upon admission, all children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics. antibiotics will be provided at admission and during follow-up only if clinically justified. the results of the program (ie, nutritional recovery, hospitalization, death and abandonment) will be monitored in all children aged 6 to 59 months admitted for outpatient therapy in 2 outpatient treatment sites in the madarounfa health district in niger. to ensure that the children included in the study receive appropriate care, the study will ask the children's leaders to return to the clinic for medical surveillance in the event of a clinical complication. program staff will facilitate appropriate management, including prescription of antibiotics if clinically justified, and transfer to hospital of all children in need of close supervision and / or comprehensive medical management.

Eligibility criteria:
inclusion criteria: * age 6-59 months * direct admission for the treatment of uncomplicated sam (muac \<115 mm or ptz \<-3 and / or presence of grade + or ++ nutritional edema and moderate or good appetite with absence of medical complications) * signed informed consent exclusion criteria: * no informed consent given * not directly admitted for the treatment of uncomplicated sam at the crenas (center for outpatient nutritional rehabilitation for malnutrition) of the study
eshap-imatinib for refractory/relapsed non-hodgkin's lymphoma

Conditions: Lymphoma, Non-Hodgkin

Summary: open-labeled, multicenter, phase i/ii study of imatinib combined with eshap as salvage therapy in relapsed/refractory non-hodgkin's lymphoma


Eligibility criteria:
inclusion criteria: 1. histologically diagnosed non-hodgkin's lymphoma, refractory or relapsed after 1st line treatment. 2. paraffin block of the lesions available for immunohistochemical analysis 3. candidate for eshap salvage therapy 4. evidence of at least one lesion with a diameter of 1.5 cm 5. age of over 20 years 6. eastern cooperative oncology group performance status (ecog) less than or equal to 2. 7. adequate kidney function with serum creatinine\< 2.5 mg/dl, creatinine clearance ≥ 50 ml/min 8. adequate liver function with aspartate transaminase (ast)/alanine aminotransferase (alt) lower than or equal to 3 times the normal upper limit; total bilirubin lower than or equal to 1.5 times the upper limit ;alkaline phosphatase lower than or equal to 5 times the normal upper limit. 9. adequate bone marrow function with absolute neutrophil count ≥ 1,000/ul; platelets ≥ 75,000/ul; hemoglobin ≥ 9.0 g/dl 10. patients who gave voluntarily informed consent before performing any test test that is not part of routine care of patients exclusion criteria: 1. patients with history of exposure to imatinib or other bcr-abl tyrosine-kinase inhibitors 2. known or suspected hypersensitivity to imatinib 3. potential use or usage alteration of cyp3a4 inducers or inhibitors from prior to 21 days of to the test regimen until the initiation of round 2 eshap. exceptions are itraconazole and fluconazole for treatment or prevention of fungal infection, hydrocortisone and dexamethasone for treatment of nausea/vomiting/fluid retention, and methylprednisolone as a part of the eshap regimen. 4. known involvement of the central nervous system (cns) by lymphoma. 5. pregnant or breast-feeding. females of childbearing potential who do not agree to undergo pregnancy tests or repeated use effective birth control while included in the clinical trial. 6. serious or uncontrolled medical condition, such as presence of abnormal or clinically significant cardiac disease, such as acute myocardial infarction or unstable angina within 6 months prior to initiation of treatment with eshap-imatinib, serious neurological or psychological conditions such as dementia or epilepsy, or uncontrolled active infection. 7. prior history of malignancy other than to non-hodgkin's lymphoma (except basal or squamous cell skin and in situ carcinoma of the cervix) unless the patient free of disease beyond 5 years are. 8. hiv positive and in treatment.