Kornimate/medical-research-clean huggingface dataset:
safety study of gene modified donor t cell infusion after stem cell transplant for non-malignant diseases

Conditions: Primary Immune Deficiency Disorders; Hemophagocytic Lymphohistiocytosis; Inherited Bone Marrow Failure Syndrome; Hemoglobinopathies; Metabolic Disorders

Summary: the purpose of this study is to determine a safe dose of bpx-501 gene modified t cells infused after a haplo-identical stem cell transplant to facilitate engraftment and the safety of rimiducid (ap1903) on day 7 to prevent gvhd.

this is a single arm dose finding study evaluating the safety and efficacy of a bpx 501 infusion (t cells genetically modified with the inducible caspase 9 suicide gene) of 3x10e6 to 1x10e7 cells/kg followed by a rimiducid infusion on day 7 after a partially mismatched, related, t cell-depleted hematopoietic cell transplantation (hct) in patients with non-malignant diseases. the purpose of this clinical trial is to determine the dose of bpx 501 t cell infusion with subsequent planned infusion of rimiducid which can facilitate engraftment and prevent the occurrence of gvhd.

Eligibility criteria:
inclusion criteria: 1. patient must meet eligibility criteria for allogeneic transplantation 2. lack of suitable conventional donor (10/10 allele matched related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor 3. males or females 4. age \ 4 months 5. diagnosis of a nonmalignant disorder considered treatable by hct. 6. hla typing will be performed at high resolution (allele level) for the hla-a, -b, cw, drbl, and dqb1 loci. i. a minimum match of 5/10 is required. ii. the donor and recipient must be identical, as determined by high resolution typing, in at least one allele of each of the following 7. if capable of reproduction, patient must agree to use contraception or abstinence to prevent pregnancy during the first year of enrollment and treatment. 8. informed consent signed by patient (if ≥18 years old) or parent/guardian (if \<18 years old). 9. fanconi anemia patients only i) patients must meet one of the following criteria to be eligible for this study: 1. any patient with fanconi anemia and bone marrow failure involving 2 of the following 3 lineages: granulocyte count \<0.5 x 109/l, platelet count \<20 x 109/l, or hemoglobin \<8 g/dl. 2. any patient with fanconi anemia who requires red blood cell or platelet transfusions because of marrow failure 3. any patient with fanconi anemia who has a life-threatening bone marrow failure involving a single hematopoietic lineage. exclusion criteria: 1. serious organ dysfunction 2. pregnant or breast-feeding 3. evidence of hiv infection 4. bovine product allergy 5. patients with an active infectious disease 6. patients with fanconi anemia with aml/mds.

Keywords: severe combined immune deficiency congenital t-cell defect congenital t-cell deficiency chronic granulomatous disease shwachman diamond syndrome diamond blackfan anemia dyskeratosis congenita fanconi anemia sickle cell disease thalassemia mucopolysaccharidosis sphingolipidoses
hydroxychloroquine dosing and toxicity in ophthalmology clinics

Conditions: Hydroxychloroquine Toxic Retinopathy

Summary: this study assesses the ocular toxicity in patients on high dose hydroxychloroquine (hcq) as per the latest guidelines of the american academy of ophthalmology (aao).

hydroxychloroquine (hcq) is an anti-malarial drug that is used to treat a variety of autoimmune diseases, such as rheumatoid arthritis and systemic lupus erythematosus, juvenile idiopathic arthritis and sjogren's syndrome. hydroxychloroquine is a less toxic metabolite of chloroquine. there is an ongoing increase in the number of patients who are using hcq for prolonged duration because of the expanding indications and the relatively safe systemic profile. hydroxychloroquine can cause variable ocular adverse effects including corneal deposits, posterior sub-capsular cataract, ciliary body dysfunction and toxic retinopathy. toxic retinopathy caused by hcq has been recognized for many years. patients with toxic retinopathy usually complain of blurry vision. the classical clinical picture of hcq toxic retinopathy is a bilateral bull's-eye maculopathy, which is caused by a ring of parafoveal rpe depigmentation that spares the fovea. the exact mechanism responsible for the development of this pattern is not fully understood, however, it is believed that the primary damage is in the photoreceptors and outer nuclear layer leading to secondary disruption of the rpe.

Eligibility criteria:
inclusion criteria: * patients on hydroxychloroquine therapy who came for their ophthalmology screening appointment irrespective of the duration of use of the medication. exclusion criteria: * patients who have stopped their hydroxychloroquine medication.

Keywords: hydroxychloroquine toxic retinopathy hydroxychloroquine screening
the effect of long-term momordica charantia supplementation on blood glucose levels

Conditions: Glucose, High Blood; Impaired Glucose Tolerance

Summary: the study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. the main study parameter is fasting levels of plasma glucose.

bitter gourd (bg) (momordica charantia) is a highly nutritive vegetable from the cucumber family. the objective is to assess the impact of 12-weeks of bg supplementation on blood glucose levels in subjects with impaired fasting glucose levels. in a previous trial (bitter-zoet nl70259.081.19) the short-term effects of bg (4 weeks) were studied, but no effect was observed. in the current trial a different bg cultivar is chosen, the intervention period is prolonged, the dosage per day is higher and study subjects with slightly higher fasting blood glucose levels will be included. the study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. the main study parameter is fasting levels of plasma glucose. secondary outcome measures are glucose tolerance, hba1c, insulin and homa-ir and homa-b levels.

Eligibility criteria:
inclusion criteria: * age 40-75yrs * bmi \>25 kg/m2 * having a fasting glucose \>6.1 mmol/l exclusion criteria: * use of medication/supplements that may influence the study results, such as metformin, gliclazide, glimepiride, tolbutamide, insulin, sitagliptin (dpp4 inhibitor), liraglutide (glp-1 agonist), acarbose, repaglinide, pioglitazone, corticosteroids (systemically) , sglt-2 inhibitors, (judged by our research physician) * having a fasting glucose \>11.0 mmol/l * history of gastro-intestinal surgery or having (serious) gastro-intestinal complaints * history of liver dysfunction (cirrhosis, hepatitis) or liver surgery * reported slimming, medically prescribed or other extreme diets * reported weight loss or weight gain of \> 5 kg in the month prior to pre-study screening * not willing to give up blood donation during the study * current smokers * alcohol intake ≥14 glasses (women) or \>21 glasses (men) of alcoholic beverages per week, on average * pregnant or lactating (self-reported) * abuse of illicit drugs (soft- and hard drugs) * food allergies for products that we use in the study * participation in another clinical trial at the same time * being an employee of the food, health \& consumer research group of wageningen food \& biobased research or dept. human nutrition and health of wageningen university.

Keywords: bitter gourd pre-diabetes fasting blood glucose
protective versus conventional mechanical ventilation for peripheral vascular surgery.

Conditions: Lung Diseases

Summary: background and goal of the study: postoperative complications following major surgeries are associated with a significant increase in costs and mortality. there is increasing evidence that mechanical ventilation with a protective strategy using low tidal volume prevents postoperative pulmonary complications. peripheral vascular surgeries include particularly surgeries for arterial revascularization of the lower limbs in patients with advanced peripheral vascular disease. these procedures are strongly associated with major cardiovascular morbidity postoperatively. in this specific group of patients, the presence of postoperative pulmonary complications (ppc) may be associated with worsening of clinical outcomes with a consequent significant increase in perioperative morbidity. subjects and methods: in this study, the investigators aimed to compare the effects of controlled mechanical ventilation with the use of a protective strategy (low tidal volume associated with elevated peep) when compared to the conventional strategy (higher tidal volume associated with reduced peep levels) on the rate of ppc in patients undergoing peripheral vascular surgery. this study was delineated as a prospective trial, compared to the control group (conventional ventilation strategy). patients and researchers were blinded during data collection. the investigators included adult patients, asa status ii to iv, aged over 18 years, scheduled to undergo lower limb arterial bypass surgery. patients were randomized to treatment with conventional mechanical ventilation (tidal volume between 9 to 10 ml.kg-1 of predicted body weight and peep between 3 and 5 cmh2o - group i or control) or treatment with protective ventilation strategy (tidal volume of 6 to 7 ml.kg-1 of predicted body weight and peep of 6 to 8 cmh2o - group ii or treatment). the primary outcome was ppc and the secondary endpoint included hemodynamic and metabolic changes perioperatively. statistical analysis was performed using the intention-to-treat method.


Eligibility criteria:
inclusion criteria: * this study enrolled only patients displaying peripheral occlusive arterial disease and scheduled to undergo an elective peripheral artery bypass surgery. exclusion criteria: * the illiterate or who do not understand portuguese language, those who had a body-mass index (bmi) higher than 35 kg/m2, had severe pulmonary comorbidities or another disorder that might compromise a safe trial procedure and those who refused to participate of the study or who had already participated in other studies.

Keywords: mechanical ventilation protective ventilation vascular surgery postoperative pulmonary complications
seniorworkinglife (danish title: seniorarbejdsliv)

Conditions: Work Related Upper Limb Disorder; Musculoskeletal Pain; Work Accident; Work Injury; Work-Related Stress Disorder; Occupational Exposure; Occupation-related Stress Disorder

Summary: due to demographic changes across europe there are strong political interests in maintaining the labour force by prolonging working life, i.e. increasing retirement age. the present study investigates push and stay mechanisms for labor market attachment among older (+50 yrs) workers or people who have recently retired.

due to demographic changes across europe there are strong political interests in maintaining the labour force by prolonging working life, i.e. increasing retirement age. the present study investigates push and stay mechanisms for labor market attachment among older workers or people who have recently retired. the study is a questionnaire survey, which is already funded. the ambition is to apply for further funding to do a cohort that is repeated every 2-3 years, as well as long-term register follow-up in danish national registers about health and work. the study has 4 target groups: 1. employed 2. unemployed 3. early retirement 4. disability pension the questionnaire survey is sent to 30,000 danish citizens and contains the following 14 areas: 1. basic information (demographics, employment status etc.) 2. broad overview of factors that may influence labor market attachment (health, working conditions, economic factors) 3. role of the workplace 4. age-discrimination 5. economy 6. specific questions about the possibility for 'early retirement' among employed and unemployed 7. gradual retirement (e.g. possibility for reduced time or responsibility) 8. competencies and continuing education/training of skills 9. return-to-work 10. new technologies at the workplace 11. job satisfaction and well-being 12. working environment (physical, psychosocial etc.) 13. lifestyle 14. health and functional capacity the study is supported by a grant from trygfonden

Eligibility criteria:
inclusion criteria: labor market status of: * employed (employed at least 20/37 hours per week 1.quarter of 2018) or * unemployed (unemployed at least 20/37 hours per week 1.quarter of 2018) or * early retirement or * disability pension exclusion criteria: * those that do not fullfill the above inclusion criteria
a study of postsurgical pain control for lower extremity fractures

Conditions: Lower Extremity Fractures.

Summary: postsurgical pain may effectively be treated with a multimodal approach that incorporates the use of local anesthetics. bupivacaine is a local anesthetic that has been proven to be effective at reducing postsurgical pain. furthermore, this local anesthetic has been shown to reduce opioid use, improve functional outcomes, allow for early mobilization, and decrease hospital length of stay. however, local anesthetics, via wound infiltration, are often short-acting and do not meet the duration of postsurgical pain due to their solubility and protein-binding properties. expareltm is an fda-approved liposomal formulation of bupivacaine that allows for 72 hours of postsurgical analgesia with a single injection. this formulation has been shown to have little to no adverse effects; although some studies have reported adverse effects with the use of exapreltm, most frequently being nausea, vomiting, and dizziness. the occurrences of these adverse events were still less than the placebo cohort.

all patients undergoing surgical fixation of a lower extremity fracture(s) will be offered the opportunity to enroll in the study. patients undergoing unilateral or bilateral surgical fixation would be included. written, informed consent to enrollment will be recorded and included in the patient record. the study is designed around the standard of care for postsurgical pain management. there are no additional costs to the patient strictly related to this study. patients will undergo surgical fixation of a lower extremity fracture(s) by one of surgical investigators at a single institution. a sealed, opaque envelope, selected in the pre-operative holding area, will accompany each patient participant to the operating room. the envelope will be opened at the conclusion of the fracture fixation to reveal patient assignment to either study group 1 or group 2. once the total numbers of patients have completed their procedures and follow-up, the study will close.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age * preoperative diagnosis of lower extremity fracture(s) requiring surgical fixation exclusion criteria: * allergy to expareltm or certain other local anesthetic agents * surgery performed at an outside institution or by a different surgeon * chronic analgesic users (defined as use of opioid medication \>14 days in the past 3 months, or use of non-opioid pain medication \>5 times per week * pregnant females or females who think they may become pregnant * peripheral neuropathy * major psychiatric disease * inability to comprehend the nature of the study * unwillingness to provide signed informed consent * markedly abnormal kidney function or renal disease * non-english speaking * signs or symptoms of compartment syndrome

Keywords: bupivacaine multimodal exparel open reduction internal fixation post-surgical pain control
amyloid accumulation after mild traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: there will be 200 participants, who aged 30 years or older with tbi in 1,5,10,15 years ago and gcs=13-15 will be recruited. another group of 200 participants with the same age and gender and without tbi will be recruited as the controls. all of them will undergo ad8 questionnaire for dementia screening and apoe4 genotyping. further casi and cdr will be tested for the confirmation of dementia diagnosis for the individuals with ad8 scaore \>/=2. 10 tbi with dementia, 20 tbi without dementia and 10 controls will be selected randomly for av45 amylid pet study. there will also be 10 participants without traumatic brain injury and interested in this study, aged 55 years or older better.

we will examine the mtbi patients in a long-term follow-up manner by cognitive tests and a-pet. this is a novel study for linking mtbi and ad by solid, reliable methods, in terms of a-pet and cognitive function tests. in addition, we will figure out the importance of apoe genotypes for amyloid accumulation and cognitive impairment. these results should shed light on the further clinical studies and amyloid-cleaning therapy for prevention and treatment for dementia after mtbi.

Eligibility criteria:
inclusion criteria: * the individuals are listed in the taipei medical university traumatic brain injury databank and had tbi in 1, 5, 10 and 15 years ago. there are about 200 individuals undergo telephone interview/invitation, blood test for genotyping and neuropsychological tests. 30 participants will be selected randomly among the 200 individuals. * mild injury in tbi (initial gcs = 13-15) * had mri or ct evaluation after tbi * aged 30 years or older better * agreed by principal investigator * have agreement and have signed the informed consent form by him/herself or his/her legal representative main exclusion criteria: * participating in another clinical trials which might interfere the current finding. * not sure the timing of tbi * contaminant the symptoms with injury, skull fracture, intracranial hemorrhage, craniotomy, and death * moderate (initial gcs = 9-12) or severe (initial gcs \< 8) injury in tbi * had wound with gunshot or puncture * loss of consciousness over 30 minutes after tbi * loss of memory for over 1 day after tbi * have no mri or ct evaluation of brain after tbi or have obstructive ischemia after mri or ct evaluation * have uremia, liver cirrhosis, heart failure, pulmonary edema, coagulation disorders and other major diseases * pregnant woman or emotional instability * the age less than 18 years (30 years better) * unable to collect blood sample by peripheral vein * determination of inappropriate participants in the clinical trail of pi

Keywords: traumatic brain injury mild tbi alzheimer's disease [18f]av-45 pet amyloid binding imaging
to evaluate the therapeutic equivalence and safety in treatment of moderate facial rosacea

Conditions: Rosacea

Summary: to demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of moderate facial rosacea.

a multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing test and reference products and both active treatments to a placebo control in the treatment of moderate facial rosacea.

Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial rosacea. * subjects must have provided irb approved written informed consent. exclusion criteria: * female subjects who are pregnant, nursing or planning to become pregnant during study participation. * subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
empa-kidney (the study of heart and kidney protection with empagliflozin)

Conditions: Chronic Kidney Disease

Summary: the primary aim of the study is to investigate the effect of empagliflozin on kidney disease progression or cardiovascular death versus placebo on top of standard of care in patients with pre-existing chronic kidney disease. after completion of the interventional part of the study (primary study completion) a subset of participants will be followed up in a post-trial observational (non-interventional) manner for cardio-renal outcomes (estimated study completion date).


Eligibility criteria:
inclusion criteria: * age ≥18 years or at "full age" as required by local regulation * evidence of chronic kidney disease at risk of kidney disease progression defined by at least 3 months before and at the time of screening visit * ckd-epi egfr ≥20 to \<45 ml/min/1.73m² or * ckd-epi egfr ≥45 to \<90 ml/min/1.73m² with urinary albumin:creatinine ratio ≥200 mg/g (or protein:creatinine ratio ≥300 mg/g); * clinically appropriate doses of single agent ras-inhibition with either acei or arb unless such treatment is either not tolerated or not indicated * a local investigator judges that the participant neither requires empagliflozin (or any other sglt-2 or sglt-1/2 inhibitor), nor that such treatment is inappropriate; key exclusion criteria: * currently receiving sglt-2 or sglt-1/2 inhibitor * diabetes mellitus type 2 and prior atherosclerotic cardiovascular diseasee with an egfr \>60 ml/min/1.73m2 at screening * receiving combined acei and arbf treatment * maintenance dialysis, functioning kidney transplant, or scheduled living donor transplant * polycystic kidney disease * previous or scheduled bariatric surgery * ketoacidosis in the past 5 years * symptomatic hypotensiond, or systolic blood pressure \ 180 mmhg at screening * alt or ast \>3x uln at screening * hypersensitivity to empagliflozin or other sglt-2 inhibitor * any intravenous immunosuppression therapy in last 3 months; or anyone currently on \>45 mg prednisolone (or equivalent) * use of an investigational medicinal product in the 30 days prior to screening visit * known to be poorly compliant with clinic visits or prescribed medication * medical history that might limit the individual's ability to take trial treatments for the duration of the study (e.g. severe respiratory disease; history of cancer or evidence of spread within last 4 years, other than non-melanoma skin cancer; or recent history of alcohol or substance misuse) * current pregnancy, lactation or women of childbearing potential (wocbp), unless using highly-effective contraception * type 1 diabetes mellitus