Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of ibi362 in subjects with and without renal impairment

Conditions: Renal Impairment

Summary: the purpose of this study is to assess how fast ibi362 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.


Eligibility criteria:
inclusion criteria: * all participants: o the weight of male subjects is not less than 50 kg, and the body weight of female subjects is not less than 45 kg, and the body mass index (bmi) is within the range of 20\~30 kilograms per meter squared (kg/m²), inclusive, at screening * healthy participants: -- healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (egfr) ≥90 milliliters per minute (ml/min) at screening * participants with renal impairment: * males or females with stable mild to severe renal impairment, assessed by egfr exclusion criteria: * all participants: * pregnant or lactating women, or men or women who are of childbearing potential and are not willing to use contraception within 6 months from the screening period to the administration of the study drug * have known allergies to ibi362 or related compounds * have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 * have serum aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>1.5× the upper limit of normal (uln) or total bilirubin (tbl) \>1× uln * severe gastrointestinal diseases (such as active ulcer, pyloric obstruction, inflammatory bowel disease, etc.) occurred within 6 months before screening, or received gastrointestinal surgery or long-term use of drugs that directly affect gastrointestinal motility due to chronic gastrointestinal diseases * have a history of acute and chronic pancreatitis, or serum amylase and/or lipase ≥ 1.5× uln at screening, or fasting triglyceride ≥ 5.64 mmol/l (500 mg/dl) * participants with renal impairment: * obstructive urinary tract diseases (such as urinary stones, urinary tract obstruction caused by abdominal space-occupying lesions, etc.) or renal dysfunction caused by special types of renal parenchymal damage (such as polycystic kidney, medullary sponge kidney, renal tumors, etc.) and/or patients with renal impairment who have diseases that are not related to renal disease but can cause renal impairment (eg, renal artery stenosis, acute drug injury, severe infection, hypovolemia, heart failure, etc.). * have a history of kidney transplant * the treatment medication and/or the treatment medication of other comorbid diseases have been taken stably for less than 1 month at screening, or there are new medications within 1 month before screening (except temporary or intermittent use of drugs, such as erythropoietin once a month, or diuretics as needed, etc.), or received any drug known to alter renal tubular creatinine secretion within 14 days or 5 half-lives before screening, such as cimetidine d, trimethoprim or cibenzoline, etc.
heliox-powered albuterol therapy in the treatment of children admitted with acute asthma exacerbation

Conditions: Status Asthmaticus

Summary: the purpose of this study is to investigate whether heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations.

we hypothesize that heliox-powered albuterol nebulizer therapy will result in reduced inpatient length of stay in children hospitalized with acute asthma exacerbations. severity of asthma will be characterized using a modified becker clinical asthma score (cas) based upon the acuity of physical signs for four clinical characteristics (respiratory rate, wheezing, i/e ratio, and accessory muscle use). scoring will occur at the time of enrollment and every 4 hours thereafter until the patient meets hospital discharge criteria. all scoring using the cas will be performed by an independent physician, nurse or respiratory therapist blinded to the subject treatment arm. all children will receive standard cardiopulmonary monitoring and treatment, consisting of supplemental oxygen delivered as needed by either nasal cannula or face mask to maintain oxygen saturation \>90%, maintenance intravenous fluids, corticosteroid therapy and nebulized albuterol therapy. after written informed consent, eligible children will be randomized to one of two study groups using a sealed envelope technique: group 1 (heliox-powered albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 70:30 heliox. group 2 (oxygen-powered albuterol) patients will receive all albuterol nebulizer treatments, including continuous therapy, powered by 100% oxygen per usual standard of care.

Eligibility criteria:
inclusion criteria: * age 2 -18 years; * previous history of asthma; * hospital admission for acute asthma exacerbation; * clinical asthma score greater than or equal to 3 exclusion criteria: * less than 2 years old or over 18 years old; * known allergy or hypersensitivity to ß-agonists; * require mechanical ventilation (invasive or non-invasive); * require fio2 \>0.4; * failure to obtain informed consent; * enrollment in another investigational drug or asthma protocol; * incipient respiratory failure including but limited to respiratory acidosis(pco2\>60 torr), altered mental status and/or excessive work of breathing.

Keywords: status asthmaticus asthma helium children
sitagliptin and endothelial dysfunction

Conditions: Healthy

Summary: over the years, numbers of cardioprotective drugs have been evaluated to attenuate lethal ischemia-reperfusion (ir) injuries. there is little study whether sitagliptin protects against endothelial dysfunction induced by ir injury in humans.

glucagon-like peptide-1 (glp-1) is a novel insulinotropic peptide which is rapidly degraded by the enzyme dipeptidyl peptidase-4 (dpp-4). in addition to its attractive merit in type 2 diabetes, interest in the cardioprotective effects of glp-1 has been increased with various reports and evidence. previously, the investigators could show exenatide, glp-1 receptor agonist protects ischemic/reperfusion injury-induced endothelial dysfunction through opening of katp (atp-sensitive potassium) channels in human ischemic/reperfusion injury model. but, recent clinical studies showed 2 different dpp-4 inhibitors, alogliptin and saxagliptin, did not decrease major adverse cardiovascular events even though improving glycemic control. the investigators will investigate the role of sitagliptin in human ischemic/reperfusion (ir) injury model of forearm conductance vessels as previous described method.

Eligibility criteria:
inclusion criteria: * healthy volunteer age 20 to 40 years * non-smoker exclusion criteria: * high blood pressure (\>140/90 mmhg) or any antihypertensive medications * diabetes * any cardiovascular disease * kidney disease * thyroid disease * cerebrovascular disease * liver disease (bilirubin level \>2 mg/dl) * pregnancy * body mass index \>25 kg/m2

Keywords: sitagliptin endothelium ischemia-reperfusion injury human
quantitative evaluation of the breast's morphological variations during radiotherapy: morphobreast3d

Conditions: Breast Cancer Female; Adjuvant Radiotherapy

Summary: quantitative evaluation of the breast's morphological variations during radiotherapy consisting in performing three-dimensional surface acquisitions of the breast in order to study its shape and volume. evaluation of the dosimetric impact of these variations.


Eligibility criteria:
inclusion criteria: * women * in situ or invasive breast carcinoma * treated by conservative breast surgery * pre-treatment with authorized chemotherapy * eligible for conventional breast irradiation in 25 sessions of 2 gy with or without irradiation of the tumor bed and lymph nodes area * conventional 3d radiotherapy technique * bra cup size from a to d included * speaking and understanding french * having given written consent * patient with health insurance exclusion criteria: * surgical treatment by mastectomy * no indication for breast radiotherapy * local or diffuse inflammatory state of the breast at inclusion * history of epilepsy or anticonvulsive treatment for preventive or curative purposes * bmi\> 30kg / m2 * t4 stage tumor * bilateral breast tumor * use of a ventilatory control to treat the patient * minor patient or major incompetent * patient deprived of liberty * patient under safeguard of justice

Keywords: volume variation deformation repositioning dosimetric quality 3d scan
sleep ventilation for patients with advanced hypercapnic copd

Conditions: COPD

Summary: despite growing evidence showing benefit (in both clinical and cost standpoints), only a small percentage of copd patients with chronic hypercapnic respiratory failure are managed with nocturnal ventilatory support. there is uncertainty of the value of aggressive nocturnal ventilation, especially polysomnographic estimation of therapy and home transcutaneous co2 tracking. the driving goal behind this project is to develop and implement a streamlined and comprehensive program for nocturnal ventilator management of patients with advanced, hypercapnic copd.

the purpose of this protocol is to perform a prospective, randomized, comparative effectiveness clinical trial to evaluate the role of non-invasive nocturnal ventilation in addition to usual care, compared to usual care alone in the management of adult copd patients with chronic hypercapnic respiratory failure. the study will focus on the primary end-points of time to hospital re-admission for acute exacerbation of copd and/or an episode of acute on chronic hypercapnic respiratory failure, in addition to other clinically relevant outcomes including patient health-related quality of life, sleep quality indices, and gas exchange parameters. approximately 300 bidmc adult patients will be recruited and each patient monitored over a period of 12 months.

Eligibility criteria:
inclusion criteria: 1. signed informed consent prior to any study-mandated procedure. 2. male or female aged ≥ 18 years with advanced hypercapnic copd 1. fev1 ≤ 50% predicted and 2. prolonged hypercapnia during the daytime, at rest, without o2 or ventilatory support, paco2 \> 52 mmhg on abg (performed off of nippv), compensated with ph \> 7.30 3. willingness to use nippv treatment 4. english speaking women and minorities will be recruited in numbers reflecting representation in the boston metropolitan community which is approximately 84% caucasian, 9% african american, 5% hispanic american, and 2% asian american, as the knowledge gained can apply to individuals of all ethnic background and gender. we do not wish to limit our sample to a highly selected group of patients, to allow for more generalizable results. exclusion criteria: subjects will be excluded from participation in the study for a history of: * significant sleep disordered breathing (ahi 4% ≥ 15 events/hour) or high clinical suspicion (bmi ≥ 35) * neuromuscular disease or other causes of hypoventilation * abnormalities of the thorax or lungs other than copd * already treated with home nippv * unable to wean from ventilator during admission * unable to wean from nippv, ph \< 7.30 * recent tracheotomy decannulation * history of severe depression or bipolar disorder requiring prior hospitalization or suicide attempts or ideation * cognitive impairment (such as advanced dementia) that would limit ability to provide consent or to use nippv * active recreational drug use * unstable housing that would limit ability to use nippv * severe heart failure (new york heart association stage iv) * active/unstable cad
a randomised trial of a moisturising cream in preventing recurrence of hand eczema

Conditions: Hand Eczema

Summary: the purpose of this study is to investigate whether a moisturizing cream can prevent hand eczema.patients with previous hand eczema will be studied. in the second part of the study, it will be explored if a treatment regimen of a topical corticosteroid once daily is not inferior to treatment twice daily.


Eligibility criteria:
inclusion criteria: * clinically proven history of hand eczema * at inclusion controlled state of hand eczema (≤3 on hand eczema extent score, hees) * daily use of moisturising treatment * either gender * age 18 or above * written informed consent exclusion criteria: * possible allergy to ingredients in the study medications * at study start active psoriatic lesions or active atopic eczema lesions on the hands. active bacterial, fungal or viral infection of the hands * patients who are pregnant or breast-feeding, or who plan to become pregnant during the course of the study * use of any concomitant medication that may interfere with the study related activities or assessment of efficacy * any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse) * any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results * inclusion in a study of an investigational drug within 60 days prior to start of treatment

Keywords: hand eczema prevention
blinatumomab as a bridge to allo-hsct in hr bcp-all

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: to explore the efficacy and safty of blinatumomab as a bridge to allogeneic hematopoietic stem cell transplantation in high risk precursor b-cell acute lymphoblastic leukemia

high risk precursor b-cell acute lymphoblastic leukemia is a kind of leukemia with poor prognosis. here, we want to explore the efficacy and safty of blinatumomab as a bridge to allogeneic hematopoietic stem cell transplantation in high risk precursor b-cell acute lymphoblastic leukemia.

Eligibility criteria:
inclusion criteria: 1. the patients meet the diagnostic criteria for high risk precursor b-all (according to the 2016 who classification) and are under hematologic remission. 2. ecog score is 0-2. 3. expecting life span is more than 6 months. 4. patients are free from severe organ dysfunction. exclusion criteria: 1. patients are combined with severe organ dysfunction: organ failure: cardiac failure: ejection fraction(ef) \ 2.5mg/ dl or blood creatinine clearance rate \< 30ml/min. 2. patients are combined with infection or other complications that can not tolerate chemotherapy. 3. patients are suffering from central nervous system/solitary extramedullary leukemia. 4. patients are considered as tumer progression. 5. patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks. 6. pregnant and lactating women will not be included.
study of the combination of afm13 and pembrolizumab in patients with relapsed or refractory classical hodgkin lymphoma

Conditions: Hodgkin Lymphoma

Summary: the purpose of this study is to establish a dosing regimen for the combination therapy of afm13 and pembrolizumab (mk-3475) in patients with relapsed or refractory (r/r) hodgkin lymphoma (hl) and to assess the safety and tolerability of this combination therapy.


Eligibility criteria:
main inclusion criteria: 1. diagnosis of cd30+ classical hodgkin lymphoma reconfirmed by histopathology. note: where reconfirmation is not possible, patients will still be eligible where they have confirmation clearly documented in their medical records. 2. relapsed or refractory disease after standard therapy including brentuximab vedotin (adcetris®). 3. completion of, if applicable, radiotherapy, chemotherapy, antibodies and immunoconjugates including brentuximab vedotin and/or another investigational drug which could interact with this trial not less than 4 weeks (or 5 half-lives of the drug, whichever occurs later) prior to first dose of study drug. cessation of small molecule tyrosine kinase inhibitors must be at least 7 days prior to first dose of study drug. 4. completion of, if applicable, an autologous stem cell transplantation (asct) at least 3 months prior to first dose of study drug. 5. eastern cooperative oncology group (ecog) performance score (ps) \<2. main exclusion criteria: 1. is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. has received prior therapy with an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent or if the patient has previously participated in mk-3475 clinical trials. 3. has received a live-virus vaccination within 30 days of planned treatment start. note: seasonal flu vaccines that do not contain live virus are permitted. 4. prior allogeneic stem cell transplantation (sct) within the last 5 years. 5. major surgery within 4 weeks prior to first dose of study drug.
assessment of safety and performances of hype stems associated to a serf acetabular cup in hip arthroplasty (2017-01-nh)

Conditions: Hip Arthropathy

Summary: the use of cementless femoral stems is known to provide satisfactory long-term clinical results. extensive and durable osseointegration of these implants has been reported in numerous series, despite the use of stems with different geometry and coating distribution. this study will validate the performance and safety of the hype (serf) stems in the context of the 93/42/eec directive and in relation to the recommendations of the meddev 2.7.1 (guideline for post-marketing follow-up), which provides for a systematic procedure for monitoring clinical data in order to verify the performance claimed for medical devices.


Eligibility criteria:
inclusion criteria: * male or female * degenerative or inflammatory hip disease requiring total hip replacement * primary or secondary osteoarthritis, * advanced joint destruction resulting from rheumatoid arthritis or traumatic origin, * avascular fracture or necrosis, * displaced subcapital and transcervical fracture as well as paprosky stages i to iib bone defects. * joint destruction of traumatic origin * following a previous operation, provided that the new device does not interfere with the material in place (osteosynthesis, joint reconstruction, arthrodesis, hemiarthroplasty, total arthroplasty). exclusion criteria: * patient with a psychological, family, sociological or geographical situation likely to hinder compliance with the study protocol and follow-up * known pregnancy in progress * breastfeeding * patient requiring a bone graft * neurological disorders or other pathology that may influence locomotion * history of sepsis in the hip to be operated on * short-term vital prognosis

Keywords: total hip arthroplasty
parathyroidectomy vs cinacalcet in the treatment of secondary hyperparathyroidism post renal transplantation

Conditions: Secondary Hyperparathyroidism

Summary: the hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (hpt) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.

persistent hyperparathyroidism (hpt) with hypercalcemia is prevalent after transplant (affects up to 25% of patients) and negatively affects graft and patient outcome. the subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet. several studies guarantee that cinacalcet is effective in controlling hypercalcemia derived of persistent hpt after renal transplantation. however, maintenance treatment is need because hypercalcemia increases quickly after treatment is stopped. this fact makes increase a lot the cost of transplantation in these patients. the hypothesis of this study is that subtotal parathyroidectomy by minimally invasive surgery is superior to cinacalcet for treatment of persistent secondary hpt post renal transplant, with minimal morbidity and significantly reduces the cost of treatment after transplantation.

Eligibility criteria:
inclusion criteria: * functioning renal transplant, gfr ≥ 30 ml / min * time post-transplant\> 6 months * pthi\>15pmol/l * calcium ≥2.63 mmol/l con phosphatemia ≤1.2 mmol/l * cervical scintigraphy * signed informed consent exclusion criteria: * contraindication to surgery

Keywords: renal transplant hypercalcemia
immunogenicity and safety of hepatitis a vaccine given at the same time of measles, mumps, rubella combined vaccine

Conditions: Measles; Mumps; Rubella; Hepatitis A

Summary: the present study will explore the immunogenicity of avaxim™ 80u-pediatric in 12-13 months turkish children and check if the administration of the mmr trivalent vaccine on the same day but at different site will interfere on immunogenicity for the four valences hepatitis a, measles, mumps, and rubella.


Eligibility criteria:
inclusion criteria: * aged 12-13 months on the day of inclusion * born at full term of pregnancy (\>37 weeks) with a birth weight ≥ 2.5 kg * informed consent form signed by the parent(s) or other legal representative * able to attend all scheduled visits and to comply with all trial procedures * subjects having received only one or no injection of vaccine against measles * subjects anti-hav seronegative according to the results obtained at the screening visit\* exclusion criteria: * participation in another clinical trial in the 4 weeks preceding the (first) trial vaccination * planned participation in another clinical trial during the present trial period * congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy * systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances * chronic illness at a stage that could interfere with trial conduct or completion * blood or blood-derived products received in the past 3 months * any vaccination in the 4 weeks preceding the first trial vaccination * vaccination planned in the 4 weeks following any trial vaccination * history of hepatitis a, mumps, measles and/or rubella infection (confirmed either clinically, serologically or microbiologically) * previous vaccination against hepatitis a with the trial vaccine or another vaccine * previous vaccination against mumps, measles and rubella with a mumps, measles and rubella trivalent combined vaccine * thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * history of seizures * febrile illness (axillary temperature ≥37.4°c\]) on the day of inclusion

Keywords: measles rubella mumps hepatitis a
safety and efficacy of levomilnacipran er (f2695 sr) in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran er versus placebo in the treatment of outpatients with major depressive disorder.


Eligibility criteria:
inclusion criteria: * men and women, 18-80 years old * currently meet the dsm-iv-tr criteria for major depressive disorder * the patient's current depressive episode must be at least 4 weeks in duration exclusion criteria: * women who are pregnant, women who will be breastfeeding during the study, and women with childbearing potential who are not practicing a reliable method of birth control * patients with a history of meeting dsm-iv-tr criteria for: * any manic or hypomanic episode * schizophrenia or any other psychotic disorder * obsessive-compulsive disorder * patients who are considered a suicide risk

Keywords: major depressive disorder depression