Kornimate/medical-research-clean huggingface dataset:
pharmacokinetics of apricitabine and tipranavir when dosed alone or together

Conditions: HIV Infection

Summary: the aim of the study is to see if apricitabine or tipranavir affect the levels of each other in the blood (pharmacokinetic interaction) when they are dosed together.

apricitabine is a new nrti in development for treatment of drug resistant hiv. tipranavir is a recently licensed protease inhibitor for treatment of drug resistant hiv. tipranavir affects the plasma concentration of some other drugs when they are used together with tipranavir. this study will examine whether the pharmacokinetics of apricitabine are changed when it is dosed together with tipranavir compared to apricitabine alone. also, the pharmacokinetics of tipranavir will be examined at steady state when it is dosed alone and when it is dosed together with apricitabine. information on the safety and tolerability of the two drugs when dosed together will also be obtained.

Eligibility criteria:
inclusion criteria: * healthy males 18-40 years old * non-smokers * no clinically significant medical history exclusion criteria: * current or relevant previous medical history of significance * hepatitis b, hepatitis c, or hiv positive * current use of prescription or otc medications * use of illicit substances or alcohol (\>14 drinks/week)

Keywords: human immunodeficiency virus anti-retroviral therapy nucleoside analogue reverse transcriptase apricitabine tipranavir bioequivalence drug-drug interaction pharmacokinetics
diagnostic value of mri for allergic broncho-pulmonary aspergilloses

Conditions: Allergic Bronchopulmonary Aspergilloses

Summary: the aim of the study is to compare the concordance between chest computerized tomography-scan (ctscan) and magnetic resonance imaging (mri) for the description of the abnormalities seen in allergic bronchopulmonary aspergillosis (abpa).

the abpa is responsible for pulmonary exacerbations in chronic bronchial diseases. the treatment of abpa consists in systemic corticosteroids and anti fungal therapy, which can have severe side effects. the diagnosis is difficult, based on several but non-specific characteristics. one of the radiologic abnormalities on ctscan could be more specific : high attenuation in impacted mucus, but this sign is found in about 30% of cases. recent articles and investigators experience seem to demonstrate that mri could provide an interesting tool for abpa diagnosis, studying the signal of bronchial impactions. the aim of the study is to describe the mri characteristics of patients with abpa and compare the results with those obtained by ctscan, and in order to determine if there is a specific signal of impaction in abpa.

Eligibility criteria:
inclusion criteria: * study patients have a diagnosis of abpa * control patients have severe asthma * all the patients are ≥ 18 years old, have social security care, signature of consent form exclusion criteria: * cystic fibrosis * other type of aspergilloses * contraindication for mri * woman without effective contraception

Keywords: ultrashort echo time magnetic resonance imaging
targon ph+ follow-up

Conditions: Shoulder Fractures

Summary: with this study results of the targon® ph+ nail, developed for the treatment of humeral head fractures, will be investigated clinically, radiological evaluation is optional. the primary objective of this study is to examine the effect of a plating treatment on the speed of recovery of functional capacity in adult patients. secondary aims are to examine the level of pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications. targon ph+ is ce certified. the study is a non-interventional cohort study sponsored by aesculap


Eligibility criteria:
inclusion criteria: - patients with a three- or four-fragment-fracture of the proximal humerus, with dislocation on x-ray * older than 60 years of age * written and signed patient consent exclusion criteria: - fractures more than 14 days old * multiple comorbidity * multitrauma (injury severity score \> 15) * prev. surgery on the injured shoulder * severely deranged function caused by a previous disease head-split proximal humerus fracture * combined humerus head and shaft fractures * pseudarthroses * crushed head cap of the humerus head (ao 11 c3 fractures) * isolated avulsion fracture of a tuberosity * unwillingness or inability to follow protocol instructions and study requirements (follow-up visits) * no signed informed consent * treatment not in line with instructions for use (ifu)

Keywords: proximal humerus fracture nailing
stenting of renal artery stenosis in coronary artery disease study

Conditions: Renal Artery Stenosis; Left Ventricular Hypertrophy

Summary: the stenting of renal artery stenosis in coronary artery disease (rascad) study is a randomized controlled trial designed to evaluate the effect of renal artery stenting+medical therapy versus medical therapy alone on left ventricular mass progression and cardiovascular morbidity and mortality in patients affected by coronary artery disease and renal artery stenosis.

patients with renal artery stenosis (ras) have high frequency of alterations of left ventricular mass and function. whether renal revascularization can improve cardiac function and structure in patients with ras is not known. the stenting of renal artery stenosis in coronary artery disease (rascad) study was planned to test whether renal artery revascularization, compared with medical therapy, affects left ventricular hypertrophy progression and clinical outcomes in a high-risk population such as patients with evidence of coronary artery disease and ras. incidental patients affected by ischemic heart disease,undergoing cardiac catheterization at a single institution, are also evaluated for the presence of ras by renal angiography at the end of coronarography. patients with ras \>50% and ≤80% are randomly assigned to stenting angioplasty plus medical therapy (angioplasty group) or to medical therapy alone (drug therapy group)and followed up. patients, randomly assigned to the angioplasty group, are revascularized by stenting. all randomized patients receive antihypertensive, statin or antiplatelet drugs according to clinical indications. the planned duration of follow-up is 5 years. the health profile of patients is described in full at study entry. cardiovascular events (ami, re-ptca, cardiac heart failure, stroke,peripheral vascular disease),death, hospitalizations and medications are carefully registered throughout the study. standard echocardiography and renal ultrasound studies are performed at baseline and repeated every year. echocardiography is performed following american society of echocardiography guidelines. lv mass is estimated using the devereux formula and indexed to body surface area.

Eligibility criteria:
inclusion criteria: * ischemic heart disease * angiographic diagnosis of atherosclerotic ras \>50% and ≤80% exclusion criteria: * atherosclerotic ras\>80% * ras secondary to fibromuscular dysplasia * ami * single functioning kidney and/or scr \>4 mg/dl * severe aortic valve stenosis * aortic aneurism necessitating surgery

Keywords: ras lvmi renal revascularization
whole body mri imaging in multiple myeloma at 3 tesla mri : added value of diffusion weighted imaging

Conditions: Multiple Myeloma

Summary: whole body mri with diffusion weighted imaging is a useful imaging tool * staging and diagnosis * therapy monitoring all patients will be scanned before and during treatment. the findings on diffusion weighted imaging will be correlated to the golden standard (computer tomography and mri (t1 and stir)).


Eligibility criteria:
inclusion criteria: * patients with clinical and laboratory findings, highly suggestive for multiple myeloma. exclusion criteria: * all patients who are not allowed to be scanned on mri (pacemaker, implants ed.)

Keywords: whole body mri multiple myeloma diffusion weighted mri whole body scan
meridian: a study to evaluate the efficacy and safety of pegcetacoplan in adults with amyotrophic lateral sclerosis (als)

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Summary: this is a 24-month, phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pegcetacoplan in subjects with amyotrophic lateral sclerosis (als)


Eligibility criteria:
inclusion criteria: * at least 18 years of age * sporadic als diagnosed as definite, probable, or laboratory-supported probable as defined by the revised el escorial criteria * slow vital capacity (svc) ≥60% of the predicted value at screening * onset of als symptoms within 72 weeks (18 months) prior to screening * total alsfrs-r score of ≥30 at screening * have vaccination within 5 years against streptococcus pneumoniae, neisseria meningitidis (types a, c, w, y, and b), and haemophilus influenzae (type b) or agree to receive vaccination exclusion criteria: * confirmed or suspected other causes of neuromuscular weakness * diagnosed with another neurodegenerative disease (examples include parkinson's disease and huntington's disease) * significant pulmonary disorder not attributed to als (eg, chronic obstructive pulmonary disease, pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension) * if taking riluzole, participant must be on a stable dose for 30 days prior to the start of the screening period. use of riluzole is not required for participation. * if taking edaravone, participant must be on a stable dose for 60 days prior to the start of the screening period. use of edaravone is not required for participation. * participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation * use of any other complement inhibitor within 30 days or within 5-half lives of the treatment (whichever is longer) prior to the start of the screening period or during study participation

Keywords: amyotrophic lateral sclerosis als motor neuron disease apl-2 apl2 pegcetacoplan
the correlations between early enteral nutrition and intra-abdominal pressure in severe acute pancreatitis

Conditions: Acute Pancreatitis; Intra-abdominal Hypertension

Summary: as an important management of severe acute pancreatitis (sap), enteral nutrition (en), especially early enteral nutrition (een) increases the blood flow of gut mucosa and stimulates the intestinal motility. moreover, een maintains the gut integrity, prevents bacterial and endotoxin translocation and thereby theoretically reduces the incidence of infections. therefore, een has the ability to reduce the infectious complications, length of hospital stay and mortality of patients with sap. however, the role of een is considered to be influenced by intra-abdominal hypertension (iah) in patients with sap. the previous studies showed that gut was the most sensitive splanchnic organ to the increase of intra-abdominal pressure (iap). when iah occurs, it reduces the blood flow of gut, and then results in the development of intestinal ischemia and edema. the hypoxia and hypoperfusion of intestine leads to the increase of permeability of the intestinal mucosal barrier, and then leads to bacterial translocation. therefore, iah could result in the gastrointestinal dysfunction. nevertheless, the different impacts of specific iap values on the tolerance of een have not been reported. furthermore, the effects of early enteral feeding on the iap in sap also remain unknown. due to the severe inflammatory response of sap, could een increase the burden of bowel, cause expansion of intestinal cavity, thus increase iap? however, there were rare literatures up to date reporting the association between een and iah in patients with sap. therefore, the present study aimed to investigate the influence of specific iap on the tolerance of early enteral feeding, as well as the effects of een on iap in sap patients. moreover, the impacts of een on the disease severity and clinical outcome of sap were also researched.


Eligibility criteria:
inclusion criteria: * the diagnosis of acute pancreatitis accords with the atlanta criteria in 1992 * within 3 days from the onset of the disease * hemodynamics stable exclusion criteria: * decompressive measures and enteral nutrition was performed before admission * ileus of lower digestive tract * pregnant pancreatitis * chronic organs dysfunction * immunodeficiency

Keywords: severe acute pancreatitis intra-abdominal pressure enteral nutrition
intravitreal triamcinolone acetonide: preventing raised eye-pressure by tracking elevations after topical steroids

Conditions: Vitreoretinal Disease; Ocular Hypertension

Summary: intravitreal triamcinolone acetonide (ivta) is a commonly employed treatment for various vitreoretinal disorders. however, approximately 23% to 50% of patients who receive ivta develop ocular hypertension after the drug is injected into the eye. similar to ivta, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. it is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable ivta. therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after ivta injection.


Eligibility criteria:
inclusion criteria: * patients diagnosed with vitreoretinal disease for which ivta has been chosen as treatment exclusion criteria: * \< 18 years old * pregnancy * breast feeding * hx of uveitis * hx of neovascularization of the iris or anterior chamber angle * hx of ocular herpes simplex keratitis * hx of glaucoma * unable to provide informed consent

Keywords: intravitreal triamcinolone acetonide side-effects ocular hypertension glaucoma prevention vitreoretinal diseases requiring ivta for treatment
evaluate effects of sprinkled format reducose in a carbohydrate-rich, mixed meal on post-prandial glycemia

Conditions: Dietary Supplement

Summary: this is a mechanistic, single-center, double-blind, placebo- and active-controlled, three-time-period, crossover study to evaluate the effect of sprinkled format reducose compared to placebo (double-blind; confirmative) and active control (open-label; acarbose - explorative) on post prandial glycemia in asian patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * willing and able to sign written informed consent prior to study entry. * participants who self-identify as asian; male or female, \>18 years of age. * established diagnosis of type 2 diabetes (documented by either hba1c 6.5 - 10.0% or a documented diagnosis of type 2 diabetes). * treatment naïve or on active therapy with metformin at a daily dose of 500-3000 mg at screening. dose of metformin must have been stable for at least 3 months prior to screening. * participants must have a hematocrit value greater than or equal to 34.0% for females and 40% for males. * participants must have a hemoglobin value greater than or equal to 11.0 g/dl for females and 13.5 g/dl for males. exclusion criteria: * fasting plasma glucose \>220 mg/dl at screening. * impaired kidney function, egfr of \<60 ml/min/1.73 m2 at screening. * bmi \>35 kg/m2. * weight ≤ 50 kg. * elevated liver transaminase \> 3 uln at screening. * ongoing or recent (i.e. \< 3 month) treatment with any oral or injectable glucose-lowering drug other than metformin. * ongoing or recent (i.e. \< 3 month) injectable insulin therapy. * ongoing or recent (i.e. \ 5% within previous 6 months. * ongoing or recent (i.e. \< 3 month) treatment with anorectic drugs, systemic steroids, medications known to affect gastric motility, or any condition known to affect gastro-intestinal integrity and food absorption. * major medical/surgical event requiring hospitalization in the last 3 months. * known allergy and intolerance to product components or paracetamol. * alcohol intake higher than 2 servings per day. a serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer. * are unable to comply with protocol procedures in the opinion of the investigator. * have a hierarchical link with the research team members. * positive pregnancy test or breast-feeding at screening. * participants who have been dosed in another clinical study with any investigational drug/new chemical entity within 30 days or 5 half-lives (whichever is longer) prior to screening. * donation of blood or significant amount of blood loss within 8 weeks prior to screening. participants must also agree to not donate blood within 8 weeks after their last visit.
safety and efficacy of dual specificity cd19 and cd22 car-t cell immunotherapy in r/r acute b lymphoblastic leukemia

Conditions: Refractory B Acute Lymphoblastic Leukemia; Relapse B Acute Lymphoblastic Leukemia

Summary: this is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity cd19 and cd22 car-t cells in patients with relapsed and refractory acute b lymphoblastic leukemia.

cd19-directed car-t cell therapy has shown promising results for the treatment of relapsed or refractory acute b lymphoblastic leukemia. cd19 and cd22 are proteins usually expressed on the surface of the b leukemia cells. the dual specificity car enables the t-cells to recognize and kill the tumor cell through recognition of cd19 and cd22.

Eligibility criteria:
inclusion criteria: 1. written informed consent could be acquired; 2. diagnosed with relapse/refractory acute lymphoblastic leukemia; 3. relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement; 4. refractory was defined as failed to achieve complete remission after two courses of induction therapy; 5. cd19/cd22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial; 6. karnofsky score ≥70; 7. results of pregnant test should be negative, and agree to conception control during treatment and 6 months after car-t infusion. 8. adequate organ function: ef≥50%; normal ecg; ccr ≥ 50ml/min or cr \ 45% of predict value; 9. at least 2 weeks intervals since the last chemotherapy; 10. at least 2 weeks intervals since the last anti-gvhd therapy if patients have ever ; exclusion criteria: 1. patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12); 2. women in pregnancy and lactation; 3. uncontrolled infection, active hbv or hcv infection, hiv positive or any other deadly bacterial/virual diseases; 4. long term use of systemic corticosteroids(5mg per day for 2 weeks); 5. any other uncontrolled life-threaten diseases; 6. patients with history of anaphylaxis to any drugs; 7. with central nervous system (cns) involvement; 8. patients with gvhd after allo-hsct who needed immunosuppressive agents ; 9. patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis; 10. other conditions that principle investigator considered may increase the risk of the patients or interference the results.

Keywords: chimeric antigen receptor t cells cd19 and cd22
bortezomib, pomalidomide, dexamethasone for systemic al amyloidosis

Conditions: Systemic Amyloidosis

Summary: this is an open-label, multicenter, phase 2 study in subjects with newly diagnosed or previous treated systemic light chain (al) amyloidosis. approximately 40 subjects will receive therapy with bortezomib, pomalidomide, and dexamethasone. the primary outcome is hematologic very good partial response and complete response rate at 6 months.

proteasome inhibitor and immunmodulators have synergistic effect for plasma cell dyscrasia. due to the fact that more than 70-80% of patients with amyloidosis have renal involvement, the application of lenalidomide is limited. thus, the investigators designed this open-label, multicenter, phase 2 study for newly diagnosed or previously treated systemic al amyloidosis with bortezomib, pomalidomide and dexamethasone regimen.

Eligibility criteria:
inclusion criteria: 1. diagnosis of al amyloidosis, confirmed by histology and typed with immunohistochemistry, immunoelectron microscopy or mass spectrometry. 2. newly diagnosed or previous treated al amyloidosis 3. patients must be ≥ 18 years of age. 4. ecog performance status 0, 1 or 2. 5. measurable disease defined by at least one of the following: ① serum free light chain (flc) ≥2.0 mg/dl (20 mg/l) with an abnormal kappa:lambda ratio or the difference between involved and uninvolved free light chains (dflc) ≥2mg/dl (20 mg/l). ②. presence of a monoclonal spike that is ≥5 g/l. 6. symptomatic organ involvement (heart, kidney, liver/gi tract, peripheral nervous system). 7. absolute neutrophil count (anc) ≥1.0 x 10\^9/l, hemoglobin ≥70 g/l, platelets ≥50 x 10\^9/l 8. egfr ≥20 ml/min/ 1.73 m\^2 9. written informed consent in accordance with local and institutional guidelines. 10. contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. exclusion criteria: 1. fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma. 2. presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 3. severe or persistent infection that cannot be effectively controlled; 4. presence of severe autoimmune diseases or immunodeficiency disease; 5. patients with active hepatitis b or hepatitis c (\[hbvdna+\] or \[hcvrna+\]); 6. patients with hiv infection or syphilis infection; 7. any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
alliance for family integrated care implementation in neonatal intensive care units

Conditions: Preterm

Summary: international, multi-centre, pluri-cultural, stepped wedge cluster controlled trial, to demonstrate superiority of site tailored 'family integrated care model'(ficare), that promotes the active participation of the parents as primary caregivers of their infants in neonatal intensive care units (nicu), versus standard nicu care delivery with regards to short-term health outcomes in high-risk newborns with prolonged hospital stay.


Eligibility criteria:
inclusion criteria for infants : 1. birth weight at or below 1500 g or gestational age at or below 34 weeks. 2. any other peri-neonatal condition anticipating nicu specialised care. 3. admission for at least 7 days 4. decision to provide full life support. inclusion criteria for adults 1. willingness to spend at least 6h per day at nicu or commitment to attend educational sessions 2. active involvement in care for their infant at least a 7 day-period 3. no intellectual or language barriers\[a\] to understanding 4. at least one primary caregivers involved in training \[b\] 5. signed informed consent exclusion criteria for children: 1. decision not to provide full life support 2. critical illness unlikely to survive 3. scheduled for early transfer to another non-ficare hospital (expected hospital stay \<7days) exclusion criteria for parents: 1. intellectual handicaps that makes difficult learning-understanding 2. communication cannot be established even with translator 3. mental, psychiatric problems or under legal supervision 4. newborn under guardianship of social services 5. lack of parental signed informed consent