Kornimate/medical-research-clean huggingface dataset:
efficacy, safety and tolerability of tideglusib to treat mild-to-moderate alzheimer's disease patients

Conditions: Alzheimer's Disease

Summary: the main purpose of this study is to evaluate the cognitive changes after administration of tideglusib versus placebo at two oral doses and two treatment regimes for 26 weeks in patients with mild to moderate alzheimer's disease. after the 26 week core treatment period, the patients may continue in the study under blinded conditions for an optional extension period up to a maximum of 39 additional weeks (total study duration up to 65 weeks), until the last patient in the study has completed the 26 week of treatment.

this double-blind, placebo-controlled, randomized, parallel group study will be conducted at multiple centers in the european union. patients with mild to moderate alzheimer's disease will undergo a screening period, and then they will be randomized to one of these four groups: tideglusib 1000 mg once daily (q.d.), tideglusib 1000 mg every other day (q.o.d.), tideglusib 500 mg q.d., or matching placebo, for a 26-week, double-blind, placebo-controlled treatment period.

Eligibility criteria:
main inclusion criteria: 1. men and women (of non-childbearing potential) with a diagnosis of probable alzheimer's disease. 2. age of 50 to 85 years. 3. mmse score 14 to 26. 4. well-tolerated treatment with one of the approved acetylcholinesterase-inhibitors and/or memantine in a stable dose main exclusion criteria: 1. significant psychiatric on medical disease. 2. any chronic liver disease as indicated by out of range values of alat, asat or direct bilirubin, clinically relevant hepatic steatosis or other clinical manifestations of liver disease 3. chronic daily drug intake of excluded concomitant medications. 4. enrollment in another investigational drug study within 3 months before the baseline visit.

Keywords: tideglusib alzheimer np-12 np031112 argo noscira
tumor rebiopsy during progression under immunotherapy for patients with lung cancer

Conditions: Lung Cancer

Summary: the objective of the study aims to collect tumor tissue at the moment of progression under immune checkpoint inhibitors (ici) in biological resources center in ambroise paré hospital, in order to insure later study on molecular mechanism involving the progression of nsclc and sclc under ici. the further analysis of research will be performed in the ea 4340 unity, biomarkers and clinical trials in cancerology and onco-hematology, uvsq, university of paris-saclay.

the study will consist of creation a tumor tissue bank, all sampling will be stored in the biological resources center of ambroise paré hospital.

Eligibility criteria:
inclusion criteria: * diagnosed nsclc or sclc; * patient treated priorly by ici and progressed under ici; * have provided written informed consent for the study; * be \>/= 18 years of age on day of signing informed consent. exclusion criteria: * patient under guardianship or curatorship; * unable to provide written informed consent for the study; * technical impossibility to carry out tissular rebiopsy under local anesthesia.

Keywords: lung cancer rebiopsy immunotherapy progression
placebo-controlled safety and efficacy study of pregabalin in subjects with post-traumatic peripheral neuropathic pain

Conditions: Neuropathic Pain

Summary: this study is designed to investigate if pregabalin is effective in treating neuropathic (nerve) pain resulting from peripheral nerve trauma due to a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury.


Eligibility criteria:
inclusion criteria: * subjects must have chronic peripheral neuropathic pain present for than 6 months after a traumatic or surgical event such as, for example, motor vehicle accident, fall, sports injury, knee or hip replacement, hernia repair, thoracotomy, mastectomy, focal/localized burns or crush injury. * subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (ivrs), have daily access to a telephone in order to complete the ivrs assessments each day, perform telephone visits and complete all required assessments/forms. * subjects must have sufficient post-traumatic neuropathic pain at screening and baseline. exclusion criteria: * subjects with neuropathic pain due to diabetic peripheral neuropathy (dpn), post herpetic neuralgia (phn), hiv, trigeminal neuralgia (tgn), carpal tunnel syndrome (cts) or with central neuropathic pain (for example, due to spinal cord injury) or with complex regional pain syndrome (crps, type i or type ii). * subjects with other pain that may confound assessment or self-evaluation of the peripheral neuropathic pain. * subjects who have failed pregabalin treatment due to lack of efficacy with an adequate course of therapy at doses greater than or equal to 150 mg/day, who have previously participated in a pregabalin clinical trial or who have been treated with pregabalin at any time during the 6 month period prior to screening. * subjects with epilepsy; pernicious anemia; hematological illnesses; known hiv infection; any clinically unstable cardiovascular (including a myocardial infarction \[heart attack\] in the 3 months prior to screening), hematological, autoimmune, endocrine, renal, hepatic (including chronic hepatitis b, hepatitis b within the 3 months prior to screening) respiratory, or gastrointestinal disease; symptomatic peripheral vascular disease including intermittent claudication; uncontrolled diabetes mellitus; untreated hypothyroidism. * subjects with a diagnosis of dsm-iv tr axis i disorder (including, for example, schizophrenia, bipolar disorder) with the exceptions of generalized anxiety disorder (gad) or major depression that is clinically stable. * subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment. * use of prohibited medications in the absence of appropriate washout periods.

Keywords: post-traumatic peripheral neuropathic pain
glycemic control and quality of life with i- port advance in pediatric t1dm

Conditions: T1DM

Summary: the incidence of t1dm in children, especially infants under 4 years of age, is increasing in the last decade. not all patients are willing or able, from different reasons, to be treated with insulin pumps. this portion of patients' needs subcutaneous insulin injections, at lest 4 injections per day, sometimes up to 8 injections per day. the recommended treatment is insulin injection before each carbohydrate content meal. since each injection may lead to pain, many patients do not inject all recommended doses. the solution could be: eat with no bolus, or not to correct glucose level to retrain from pain sensation. i-port use is able to address this issue by reducing the pain sensation accompanied with the injection. i-port advance may give a technological solution to non-insulin pump t1dm pediatric patients. there are no reports in the literature of the use of iport in children and youth. this information is essential since 95% of pediatric diabetes mellitus cases are insulin dependent and require multiple injections. better balanced diabetes in childhood may prevent complications to long range and long-term diabetes therapy. moreover, if discovered safe, the iport can be used also for other subcutaneously delivered medication in children, such as somtostatin analog, human growth hormone and clexane study is designed as 2 parts. initial part is a cross over design to compare between ipor use an injections regarding glucose in range, side effects and quality of life. second part is designed as prospective. to assess glycemic control with iport use or 3 months .

study withdrawn nor relevant

Eligibility criteria:
inclusion criteria: 1. diagnosed with type 1 diabetes mellitus 2. insulin injection ≥2 per day for at least a week. 3. use of mdi insulin: novorapid, humalog or apidra. 4. ability and willingness to perform at least 3 daily self-measured plasma glucose profiles 5. ability and willingness to adhere to the protocol. - exclusion criteria: 1. insulin pump use 2. mix insulin use -
evlp to evaluate the eligibility for transplantation of dcd-lungs

Conditions: Disorders Related to Lung Transplantation; Graft Failure

Summary: the procurement of organs from donors after cardiocirculatory death (dcd) is an accepted strategy to increase organ supply.

aim of the investigation: to compare the clinical outcome after transplantation of subjects receiving lungs procured from donors after cardiocirculatory death reconditioned and assessed by evlp, with that of subjects receiving lungs procured from brain death donors.

Eligibility criteria:
lung donors: * subjects with brain death according to neurological or cardiocirculatory criteria * age below 65 yrs * absence of massive lung contusion, aspiration, pneumonia, sepsis * absence of infection, malignancy recipients: * subjects to undergo single or bilateral lung transplantation * informed consent to participate in the study
a clinical study of js005 in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this is a multicentre, randomized, double-blind, parallel, placebo-controlled phase ii clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of js005 in the treatment of active ankylosing spondylitis.


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily particpate in this clinical study and sign the informed consent form. 2. male and female patients aged 18-75 years at the time of screening (both inclusive) 3. meet the diagnosis of active ankylosing spondylitis(as), have a record of radiological evidence consistent with the modified new york classification criteria for ankylosing spondylitis as revised in 1984 4. diagnosis of active as (active as is defined as: basdai \>= 4, total back pain score \>=4, and basdai second question spinal pain score \>=4) exclusion criteria: 1. pregnant or lactating women. 2. active diseases that may confound the evaluation of js005: other autoimmune inflammatory diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other than ankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis, etc.). 4. active inflammatory bowel disease within 6 months prior to randomization. 5. recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization. 6. history or evidence of active or latent tuberculosis (tb), defined as a positive interferon gamma release assay (igra) or purified protein derivative (ppd) at the time of screening. 7. positive hepatitis b virus test result 8. prior exposure to js005 or any other biologic that directly targets il-17 or the il-17 receptor. 9. use of \>= 2 tnf-α inhibitors.
(-)- epicatechin becker muscular dystrophy

Conditions: Becker Muscular Dystrophy

Summary: this is a 48-week open-label extension of our initial proof-of-concept study (ucd0113) in patients with becker muscular dystrophy who participated in the earlier trial. this single center study will enroll up to 10 adults who will receive the purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks. after screening visits, participants will be enrolled in the study if they meet all inclusion criteria. they will be evaluated at screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. the main criterion for success of the study will be presence of one or more biologic or strength and performance outcome measures that yield a response magnitude that allows for sufficient power in a phase ii b study with a sample size of 30 individuals.


Eligibility criteria:
inclusion criteria: * prior participation in ucd0113 bmd epicatechin pilot study * male * age 18 years to 70 years * average to low daily physical activity * ability to ambulate for 75 meters without assistive devices * diagnosis of bmd confirmed by at least one the following: * dystrophin immunofluorescence and/or immunoblot showing partial dystrophin deficiency, and clinical picture consistent with typical bmd, or * gene deletions test positive (missing one or more exons) of the dystrophin gene, where reading frame can be predicted as 'in-frame', and clinical picture consistent with typical bmd, or * complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) that can be definitely associated with bmd, with a typical clinical picture of bmd, or * positive family history of bmd confirmed by one of the criteria listed above in a sibling or maternal uncle, and clinical picture typical of bmd. * hematology profile within normal range * baseline laboratory safety chemistry profile within normal range * no plan to change exercise regimen during study participation * nutritional, herbal and antioxidant supplements taken with the intent of maintaining or improving skeletal muscle strength or functional mobility have been discontinued at least 2 weeks prior to screening (daily multivitamin use is acceptable). exclusion criteria: * currently enrolled in another treatment clinical trial. * history of significant concomitant illness or significant impairment of renal or hepatic function. * use of regular daily aspirin or other medication with antiplatelet effects within 3 weeks of first dose of study medication. * regular participation in vigorous exercise. * symptomatic heart failure with cardiac ejection fraction \<25%

Keywords: bmd becker muscular dystrophy epicatechin clinical trial neuromuscular disease
to test bioequivalence between two formulations of paracetamol/phenylephrine

Conditions: Respiratory Tract Infections

Summary: this study is designed to assess bioequivalence between two paracetamol/ phenylephrine combination products.

the study will be a single dose, randomized, two-way crossover study in 40 healthy subjects, with equal numbers of males and females. drop-outs will not be replaced. the two doses of medication given in the study (a single dose in each of the two study periods) will be separated by a washout period of at least 7 days. in each study period, sixteen blood samples for pharmacokinetic analysis will be taken over 24 hours. blood samples will be centrifuged and concentrations of paracetamol and phenylephrine in plasma will be measured using a validated chromatographic assay. pharmacokinetic parameters will be calculated from plasma concentration data. the rate and extent of absorption of the formulations will be compared.

Eligibility criteria:
inclusion criteria: * healthy male and female * caucasians * aged between 18 and 50 years * bmi ≤ 30 kg/m2 * clinically normal medical history * physical normal examination * normal laboratory test results exclusion criteria: * pregnancy, lactation or intended pregnancy * hypersensitivity to or intolerant of the study medications * donation or loss of blood within 90 days preceding the first dose of study medication

Keywords: nasal congestion, headache
preventive intervention in nursery school teachers

Conditions: Low Back Pain; Neck Pain

Summary: childcare in nursery schools has been shown to be associated with an elevated prevalence of neck, shoulder, arm and low back disorders. the current evidence suggests that exercises seem to be the only effective preventive intervention. thus the purpose of this study is to determine the effectiveness of an extension-oriented exercise program in preventing low back/neck pain and functional disability in nursery school teachers. in addition, the investigators also sought to identify the occurrence of musculoskeletal complaints in this category of workers.

seventy-one nursery school teachers working in nine school buildings were randomly divided into two groups, with each school as a unit of randomization. all the teachers in both groups received an ergonomic brochure; teachers in the experimental group also received an extension-oriented exercise program, conducted by a physical therapist. data were collected at baseline and at a two-month follow-up. the primary outcome measure recorded was the level of disability (roland morris disability questionnaire and oswestry disability index), while secondary outcome measures included lbp and neck pain presence (pain drawing) and intensity (visual analogue scale). at follow-up, a significant improvement was registered in the experimental group for all the outcomes evaluated. in conclusion a six-session extension-oriented exercise program proved decisive in preventing low back and neck complaints and in reducing consequent lbp functional disability among nursery school teachers.

Eligibility criteria:
inclusion criteria: the study population was composed by all the 71 nursery school teachers, employed at the town hall of forlì, that worked in nine different school buildings similar in size and furniture. as provided for by the italian law (emilia-romagna regional law no. 1 of january 10, 2000 - art. 32, followed by the directive of july 25, 2001), teachers had the same working schedule and the same workload in terms of teacher/children ratio depending on children age. exclusion criteria: * medical history of serious injury * spinal surgery * malignant pathology

Keywords: low back pain neck pain functional disability nursery school teachers exercise program prevention
collaborative care model on type 2 diabetic patients

Conditions: Type2 Diabetes

Summary: the purpose of this study is to determine the effectiveness of the collaborative care model in singapore in which clinical pharmacists, nurses and dietitians are active participants who collaborate with physicians in caring for patients with type 2 diabetes mellitus (dm).since dm is a cardiovascular risk equivalent, co-morbidities such as hypertension (htn) and dyslipidaemia (dlp) will also be evaluated to assess the holistic care provided for the investigator's patients afflicted with these top chronic diseases in singapore.

specifically, this study aims to evaluate the effectiveness of an integrated collaborative care model comprising of a healthcare team (physician, clinical pharmacist, nurse, and/or dietitian) compared to the usual or conventional healthcare model (physician-centered care) mainly in the clinical, humanistic and economic outcomes.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 21 years with type 2 dm (hba1c \> 7%) and polypharmacy (≥ 5 medications) will be eligible for this study. exclusion criteria: * patients with type 1 dm or who are unable to communicate independently in english, chinese or malay will be excluded from this study.
examining the impact of exercise training on vascular dysfunction in individuals with mental health disorders - study 2

Conditions: Peripheral Vascular Diseases

Summary: the purpose of this research study is to examine the effect of various forms of exercise training on blood vessel function in healthy individuals as well as individuals with mental health disorders (posttraumatic stress disorder (ptsd) and/or generalized anxiety disorder (gad)).

study #2 is made up of five sessions done on five separate days and the entire study can be completed in as little as 14 weeks. all testing sessions will take place at the exercise physiology research laboratory. volunteers will be asked to participate in one initial testing session (visit 1) lasting \< 1 hour that will help make them more familiar with the study equipment and procedures, determine body measures (height, weight, body fat), determine the maximum strength of their forearm and calf, and require one blood draw. the following two testing sessions (visits 2 and 3) with each session lasting between 2-3 hours that will involve multiple tests designed to determine the health of their blood vessels. for visit #2 they will be randomly given either antioxidant pills or placebo pills to determine the effect of oxidants on blood vessel health. for visit #3, they will be given whatever set of pills (antioxidant or placebo) that they did not receive during visit #2. also include two additional testing days (visits 5 and 6) that are identical to visits #2 and #3, two visits to test endurance or strength prior to and after the exercise training (visit 4 and 7), and ten weeks of exercise training (done 3-5 days per week). the exercise training will include one of three treadmill running programs that differ by exercise intensity and/or exercise frequency.

Eligibility criteria:
inclusion criteria: * apparently healthy and free of overt cardiovascular, pulmonary, or metabolic disease * for ptsd group, a score of ≥ 33 on pcl-5 checklist * for gad group, a score of ≥ 10 on the gad-7 self-report scale and \< 33 on the pcl-5 checklist * for healthy control group, a score of ≤ 10 on the gad-7 self-report scale and \< 33 on the pcl-5 checklist exclusion criteria: * taking medications that could influence cardiovascular function * current smokers who have recently quit smoking * illicit drug use or excessive alcohol consumption * pregnant women * significant calorie restriction or vitamin/mineral deficiencies * limited english proficiency

Keywords: cardiovascular disease vascular function ptsd gad oxidant
comparing two methods to stop vomiting of blood using the endoscope

Conditions: Hematemesis; Portal Hypertension

Summary: band ligation and injection sclerotherapy are two modalities of treatment that are applied using the endoscope. the purpose of this study is to determine which of two methods is better for controlling bleeding from the upper gut.

the use of band ligation for endoscopy during the attack of hematemesis is a novel practice as opposed to injection sclerotherapy.

Eligibility criteria:
inclusion criteria: * active hematemesis * esophageal varices exclusion criteria: * hemodynamic unstability * hepatic coma or precoma * tense ascitis * coagulopathies * concomitant gastric varices

Keywords: esophageal varices hematemesis endoscopy
markers of executive attention development in preschoolers - behavioral measures in various populations

Conditions: Attention Deficit

Summary: executive attention is essential for emotional and behavioral self-regulation. there is inter-individual variability in the level of efficiency of executive attention from kindergarten entry, and this variability predicts children's academic performance at entry to elementary school and beyond. it is therefore essential to better understand the early stages of executive attention development and self-regulation from an early age in order to develop tools for early detection of executive attention disorders, so that school accommodations can be proposed as early as possible. in previous work, we have identified early tactile information processing skills that underpin the development of executive attention. we would like to extend this work to a diverse population of preschool children, in order to consider new tools for the early detection of attention disorders. the mediate-prv project aims to compare the performance obtained in a validated attentional task in preschool children with assessments of tactile information processing, in relation to the psychomotor and executive development of the child. we will include 200 children aged 4 years to 5 years 11 months with different risk factors for adhd.


Eligibility criteria:
inclusion criteria: * attending preschool * parental informed consent exclusion criteria: - none