Kornimate/medical-research-clean huggingface dataset:
a study of chimeric antigen receptor t cells combined with interventional therapy in advanced liver malignancy

Conditions: Carcinoma, Hepatocellular; Pancreatic Cancer Metastatic; Colorectal Cancer Metastatic

Summary: the purpose of this study is to collect the date on the safety and potential effectiveness of cart cells combined with interventional therapy in patients with advanced liver malignancy.

designer t cells are prepared by pbmc which from patients or suitable donator by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (cars). there are three options for car-targets: gpc3 for hepatocellular carcinoma; mesothelin for pancreatic cancer metastatic; cea for colorectal cancer metastatic. cells are expanded in culture and returned to the participant by vascular interventional therapy or by intra-tumor injection at the dose of （1.25\~4）×107 car positive t cells/cm3 tumor bulk. the volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused.

Eligibility criteria:
inclusion criteria: * tumor histological examination confirmed as gpc3/ mesothelin/cea positive expression; * persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients * life expectancy greater than 6 months * satisfactory organ and bone marrow function as defined by the following: (1) creatinine \ 55%; (3) hemoglobin\>9g/dl, bilirubin 2.0×the institution normal upper limit * without bleeding disorder or coagulation disorders * don't allergy to radiocontrast agent * birth control * adequate venous access for apheresis, and no other contraindications for leukapheresis * voluntary informed consent is given exclusion criteria: * pregnant or lactating women * concurrent use of systemic steroids. recent or current use of inhaled steroids is not exclusionary * patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before * four weeks before recruit accepted radiation therapy * previously treatment with any gene therapy products * feasibility assessment during screening demonstrates\<30% transduction of target lymphocytes, or insufficient expansion (\<5-fold) in response to cd3/cd28 costimulation * any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade iii or iv cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, cns diseases) * patient with severe acute hypersensitive reaction * taking part in other clinical trials * study leader considers not suitable for this tiral
parent interventions to prevent student drinking

Conditions: Alcohol Consumption

Summary: examine the efficacy of parent interventions to prevent college student drinking in first year students.

the aims of the study are to: 1. efficacy of parent interventions to prevent college student drinking in first year students; 2. examine mediators of efficacy; and 3. examine moderators of efficacy.

Eligibility criteria:
inclusion criteria: * first year students exclusion criteria: * none

Keywords: drinking alcohol consequences
a safety and efficacy study of shr-1702 monotherapy in patients with acute myeloid leukemia (aml) or myelodysplastic syndrome (mds)

Conditions: AML; MDS

Summary: this study will assess the safety and preliminary efficacy of escalating doses of shr-1702 monotherapy in relapsed/refractory aml and intermediate-high risk mds


Eligibility criteria:
inclusion criteria: 1. male or female. 2. ≥18 years of age. 3. refractory/relapsed aml, or failed to achieve complete remission after 2 cycles of induction therapy. 4. intermediate, high and very high risk mds according to the revised international prognostic scoring system (ipss-r) who have failed prior therapies, such as azacitidine and decitabine (scoring≥3.5). 5. life expectancy≥12 months. 6. with adequate hematologic and organ function 7. signed inform consent form exclusion criteria: 1. with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest ct scan. 2. with significant cardiovascular disease. 3. with a history of autoimmune disease. 4. subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease. 5. positive test result for human immunodeficiency virus (hiv); active hepatitis b or hepatitis c. 6. active or untreated central nervous system (cns) metastases. 7. active infection within 2 weeks. 8. know to be allergic to the ingredients of shr-1702 injection. 9. prior allogeneic bone marrow transplantation or solid organ transplant 10. with a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
study to evaluate the efficacy of two treatment schemes with antivipmyn ® for the treatment of snake bite envenomation

Conditions: Snake Bite

Summary: the purpose of this study is to compare whether a same total dose given up front as a single dose is more effective and as safe as the same dose given as a fractioned dose. evaluate the utility of the the dry tube test evaluating its correlation with coagulation test results (fibrinogen, platelets, inr, pt and ptt). explore the evolution of some serum markers (ck, dhl, metalloproteinase), amount of venom and antivenom levels and the progression of local lesions.

snake bite envenomation is a public health problem especially for tropical and subtropical countries. the who estimates 40 000 annual deaths in the world for this cause. in méxico the ministry of health estimated 3 882 cases on 2005, being the age of 15-44 the most affected. there are not official numbers of mortality, although the thought is that there are few cases of death, most of them related with a delay on treatment. there are a broad variety of clinical presentations depending on many factors such as species, snake bite variability or patient conditions. proteolytic action of venom produces amines and vasoactive peptides such as bradykinin, histamine and serotonin which cause capillary lesions with anticoagulant effects. coagulopathy is one of the most important systemic consequences. the dry tube test has been proposed as an indirect test to evaluate coagulopathy related to this pathology.

Eligibility criteria:
inclusion criteria: * men and women 6 to 65 years of age * presenting for emergency treatment of snake bite * requiring treatment with antivenom * informed consent document read and signed by patient (or parent/legal guardian) * participation within the last month on any clinical trial * arrival to hospital within 24 hours after the snake bite exclusion criteria: * allergy to horse serum * underlying medical conditions that significantly alter coagulation (oral anticoagulants, vitamin k deficiency, hepatic disease) * use of aine 48 hours previously * use of any antivenom 2 weeks previously * pregnancy or breast-feeding women

Keywords: snake bite antivenin treatment
a double-blinded, randomised, four-period crossover euglycemic clamp trial investigating the dose-response and dose-exposure relationship of biochaperone insulin lispro in three different doses in subjects with type 1 diabetes

Conditions: Diabetes Mellitus Type 1

Summary: the addition of biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection. the aim of the trial is to investigate the dose-response and the dose-exposure relationships of biochaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of biochaperone insulin lispro at 0.2u/kg with humalog® at 0.2 u/kg and to assess safety and tolerability of biochaperone insulin lispro and humalog®. this is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus. each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of biochaperone insulin lispro (0.1, 0.2 and 0.4 u/kg) or one single dose of humalog® (0.2 u/kg) on 4 separate dosing visits.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for at least 12 months * treated with multiple daily insulin injections of insulin pump for at least 12 months * body mass index (bmi): 18.5-28.0 kg.m² exclusion criteria: * type 2 diabetes mellitus * receipt of any investigational product within 3 months prior first dosing * clinically significant abnormalities as judged by the investigator * any systemic treatment with drugs known to interfere with glucose metabolism * history of alcoholism or drug/chemical abuse as per investigator's judgement * use of tobacco or nicotine-contained product within 1 year prior to screening * blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
thalidomide/dexamethasone vs mp for induction therapy and thalidomide/intron a vs intron a for maintenance therapy

Conditions: Multiple Myeloma

Summary: this is an international multi-center prospective, double randomized, open, controlled phase iii study with a phase ii entrance phase to compare the therapeutic efficacy of thalidomide plus dexamethasone to conventional melphalan plus prednisone in newly diagnosed myeloma patients.


Eligibility criteria:
inclusion criteria: * patients with multiple myeloma of igg, iga, igd, ige, igm lambda or kappa light chain, low secretory or non-secretory disease * who performance status 0,1,2,or 3 * no prior treatment of multiple myeloma * clear requirement of treatment (usually durie/salmon stage ii or iii) * anticipated life expectancy of at least 3 months * adequate organ function * minimum recovery period of 2 weeks following any major surgical procedure before entry into this study * women, who are sterilized via hysterectomy or bilateral tubal ligation or at least one year post-menopausal * age of at least 19 years, there is no upper age limit patients must have been informed and must have signed an informed consent exclusion criteria: * extramedullary plasmocytoma or solitary plasmocytoma without evidence of dissemination of disease * benign monoclonal gammopathy * multiple myeloma of igm without osteolytic bone lesions * smouldering myeloma * more than 3 irradiation fields * irreversible performance status of who4 * prior treatment of myeloma with any of the following: chemotherapeutic or immunomodulatory agents, corticosteroids, antiangiogenic agents or other investigational drugs * women of childbearing potential * preexisting peripheral polyneuropathy * congestive heart failure nyha iii, iv * acute infection requiring systemic antibiotics at study entry until resolved * any uncontrolled underlying medical condition (eg diabetes, glaucoma) * second primary malignancy (with the exception of cervical carcinoma in situ and non-myeloma skin malignancies) unless patient has been disease-free for at least three years

Keywords: multiple myeloma first line treatment thalidomide melphalan
incretin effect and use after clinical islet transplantation

Conditions: Type 1 Diabetes

Summary: we aim to study if the administration of medications to increase the secretion of hormones from the intestines can improve glycemic control, reduce insulin use and promote β-cell regeneration/expansion in subjects with type 1 diabetes following islet transplantation who are back using small doses of insulin because of early graft dysfunction. we believe that the results will enable us to understand whether these drugs could be useful in islet transplant recipients, particularly if glycemic control deteriorates.

this is a single centre non-randomized pilot study. subjects will be recruited from the current cohort of islet transplant recipients at the university of alberta. the primary objective of the study is to evaluate whether the combination of sitagliptin and pantoprazole can restore insulin independence in previously insulin independent islet transplant recipients experiencing early graft dysfunction. the study will also evaluate the safety of the combination drug therapy.

Eligibility criteria:
inclusion criteria subjects must meet the following criteria to be enrolled in this study: 1. male or female, aged 18 to 70, inclusive, who is a previous islet transplant recipient (at least 3 months since last islet transplant) and who received their transplant at the university of alberta. 2. insulin independent for 3 months or longer after islet transplant. 3. early graft dysfunction as defined by: 1. hba1c \>6% (but less than 7.5%); or 2. fasting glucose \> 7 mmol/l (126 mg/dl); or 3. random glucose \> 10 mmol/l (180 mg/dl), and 4. total insulin use of \< 10 units/day. 4. c-peptide positive. 5. able to provide informed consent. exclusion criteria: subjects who meet any of the following criteria will be excluded from the study: 1. unable to provide informed consent. 2. prior therapy with sitagliptin or a proton pump inhibitor in the preceding 2 months. 3. vulnerable populations (i.e. cognitively impaired, pregnant women, residing in institutions, university of alberta students or employees under the supervision of any of the investigators). 4. children, adolescent or patients with a "contraindication" or "warning" listed in the package insert of any of the study drugs: 1. hypersensitivity to sitagliptin or pantoprazole for any component of the formulation. 2. renal disease or renal dysfunction (as suggested by serum creatinine levels ≥ 136 µmol/l (males), ≥ 124 µmol/l (females) or abnormal creatinine clearance; or estimated by glomerular filtration rate (gfr) \<50 ml/min/1.73m2). 3. acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis). 5. uncontrolled hyperglycemia 6. any subject that in the opinion of the investigator would not be a good candidate for study participation.
cardiac uptake of 18f florbetapir in patients undergoing chemotherapy

Conditions: Cardiac Amyloidosis

Summary: this is a pilot study designed to assess for relative change in cardiac 18f florbetapir uptake in patients with al cardiac amyloidosis after appropriate chemotherapy.

current research involving \[18f\]-florbetapir in relationship to cardiac amyloid has taken advantage of the ability of the radiopharmaceutical to bind specifically to amyloid fibrils. it has previously been established that the degree of radiotracer uptake correlates with the density of beta-amyloid plaque. the ability to quantify this uptake makes \[18f\]-florbetapir imaging a potential tool to evaluate cardiac response in patients undergoing therapy for al amyloidosis. it would provide a much-needed tool to monitor cardiac response to chemotherapy to potentially adjust chemotherapy if response was not adequate. it could also provide a tool by which investigators would be able to evaluate new therapies designed to decrease the burden of formed amyloid fibrils within the heart.

Eligibility criteria:
inclusion criteria: 1. patients aged \> 18 years are eligible. 2. patient must provide informed consent to participate in the study protocol. 3. all patients must have clinical diagnosis of cardiac al amyloidosis (typical echocardiographic or cardiac mri findings, nt-probnp levels above 332 pg/ml, cardiac or extra cardiac histological evidence of light chain amyloidosis). 4. planned plasma cell-directed chemotherapy. 5. a negative pregnancy test will be required for all women of child bearing potential, breast feeding is not permitted. 6. patients must be able to undergo pet-ct imaging 7. patients must be able to complete 6-minute walk test exclusion criteria: 1. severe claustrophobia 2. pregnancy 3. allergy to f-18 florbetapir

Keywords: al cardiac amyloidosis 18f-florbetapir (amyvid)
monitoring postoperative pain and recovery following orthopedic surgery

Conditions: Pain, Postoperative

Summary: this pilot study will seek to use emotion recognition technology from video to link patient facial expressions, heart rate and respiratory rate changes, and movement patterns to patient pain scores.

during hospitalization, beginning after orthopedic surgery, study participants will be asked to wear a small motion detector on their wrist. a computer vision system which analyzes both whole-body movement as well as facial expressions will be used at the bedside to compare common signs and symptoms of post op pain to patient pain scores. up to 30 study participants will be selected. study participants will be asked to complete a written pain diary during waking hours.this information will be compared to the pain scores found in the patient's medical record and/or the amount and frequency of pain medications they receive.

Eligibility criteria:
inclusion criteria: * recovery following orthopedic surgery * non-vulnerable adult patient * residing on the 6th floor of the south tower of uf health shands hospital * under the care of the acute pain service exclusion criteria: * inability to understand pain assessments * inability to wear a motion tracking device * amputation of limb * vulnerable subject status * anticipated discharge from hospital within 24 hours following enrollment * \< 21 years of age

Keywords: postoperative pain symptoms video recording orthopedic surgery
inspiratory muscle training immediately after lung transplantation

Conditions: Lung Transplantation; Chronic Lung Disease; Muscle Weakness; Rehabilitation

Summary: following lung transplantation (ltx), patients may exhibit respiratory and skeletal muscle weakness that will affect exercise capacity, increase dyspnea and fatigue, limit activities of daily living (adl) and decrease quality of life. inspiratory muscle training (imt) has been extensively studied in a variety of non-ltx populations and research has shown that imt improves exercise capacity, diaphragmatic thickness, and reduced dyspnea during activities of daily living and improved quality of life in patients with advanced lung disease. the aim of this randomized controlled study is to investigate the benefits of providing inspiratory muscle training via use of an inspiratory muscle trainer device in addition to standard physical therapy in the acute phase of rehabilitation following ltx. patients targeted for enrollment will be those with any type of advanced lung disease requiring ltx with the objective of demonstrating improvements in respiratory muscle recovery, perceived dyspnea, severity of fatigue, and overall functional status following the transplant procedure.


Eligibility criteria:
inclusion criteria: * participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study * active on the waiting list for lung transplantation * able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device exclusion criteria: * already participating in a regular imt program * impaired cognition with inability to follow commands
a phase i study of fluzoparib in patient with advanced solid malignancies

Conditions: Advanced Solid Malignancies

Summary: fluzoparib is an oral potent, selective parp-1 and parp-2 inhibitor. the objective of this study will be to investigate the safety and tolerability of fluzoparib capsule when given orally to chinese patients with advanced solid malignancies. in addition, the pharmacokinetic profile, mtd (if possible) and efficacy of fluzoparib will be investigated.


Eligibility criteria:
inclusion criteria: * ecog performance status of 0 to 1. * life expectancy of more than 12 weeks. * at least one measurable lesion exists.(recist 1.1). * subjects diagnosed with advanced solid malignancies who are refractory to standard therapies or for which no standard therapy exists. * subjects who have overall good overall general condition. * signed informed consent. exclusion criteria: * subjects who received any previous treatment with a parp inhibitor. * less than 4 weeks from the last clinical trial. * less than 4 weeks from the last radiotherapy, chemotherapy, surgery, hermone treatment and target therapy. * subjects that are unable to swallow, or dysfunction of gastrointestinal absorption. * subjects with symptomatic uncontrolled brain metastases. * subjects with uncontrolled hypokalemia and hypomagnesemia before study entry. * subjects with a known hypersensitivity to fluzoparib or any of the excipients of the product. * ongoing infection (determined by investigator). * history of immunodeficiency, including hiv-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation. * subjects who can not interrupt the using of the drugs that may cause qt prolongation during study. * subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) any heart diseases judged by investigator as unsuitable to participate in the trial. * female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.

Keywords: parp advanced solid malignancies fluzoparib ovarian cancer brca
safety and tolerability of multiple doses of pf-04950615 (rn316) in subjects with hypercholesterolemia

Conditions: Hypercholesterolemia; Dyslipidemia

Summary: the primary objective of this study is to evaluate the safety and tolerability of repeated doses of pf-04950615 (rn316) in study volunteers with hypercholesterolemia. pf-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.


Eligibility criteria:
inclusion criteria: * ldl-c must be greater or equal to 130 mg/dl * bmi must be between 18.5 and 40 kg/m2 * japanese volunteers must have 4 japanese grand parents born in japan exclusion criteria: * history of cardiovascular or cerebrovascular event during the past year. * poorly controlled type 1 or type 2 diabetes mellitus * subjects who have taken lipid lowering therapies within the last 3 months of screening.

Keywords: hypercholesterolemia dyslipidemia ldl high cholesterol japanese volunteers pf-04950615 rn316
multi-detector computer tomography protocol project: chest imaging technique and case presentation

Conditions: Aortic Dissection; Thrombosis in Left Atrium and Right Axillary Artery; Double IVC; May-Thurner Syndrome; Pulmonary Thromboembolism

Summary: multi-detector computer tomography protocol project: chest imaging technique and case presentation.


Eligibility criteria:
inclusion criteria: * patients with complete clinical images exclusion criteria: * patients with incomplete clinical images