Kornimate/medical-research-clean huggingface dataset:
felodipine event reduction study

Conditions: Hypertension

Summary: fever is an investigator-designed, prospective, multicentre,double-bind, randomized, placebo-controlled,parallel-group trial. the primary objective is to compare the long-term effects on the incidence of fatal and non-fatal stroke (and secondarily of other cardiovascular events) of administering a small dose of the calcium antagonist felodipine (5 mg once a day) or of a placebo, in hypertensive patients whose blood pressure had preliminarily been reduced by administering a low-dose diuretic (hydrochlorothiazide,12.5 mg once a day) to be continued in association with felodipine or placebo, throughout the trial.


Eligibility criteria:
inclusion criteria: * sbp of 210 mmhg or less and dbp less than 115 mmhg if under antihypertensive treatment; sbp 160-210 mmhg or dbp 95-115 mmhg if untreated. presence of at least one or two risk factors or cardiovascular diseases informed consent obtained exclusion criteria: stroke or myocardial infarction during the previous 6 months; secondary hypertension; unstable angina; cardiomyopathy or significant valvular disease; serum creatinine greater than 178 mmol/l (2.0 mg/dl); gout; uncontrolled diabetes(fasting plasma glucose \> 10 mmol/l, 180 mg/dl despite therapy); serious pulmonary or hepatic disease; known contraindications to study drugs; unwillingness to cooperate

Keywords: hypertension felodipine moderate to high risk patients
pan-genome analysis of neuroblastoma by comparative genomic hybridization and correlation with pathology for the diagnostic and the prognostic classification

Conditions: Neuroblastoma

Summary: neuroblastoma (nb) is characterized by its wide heterogeneity in clinical presentation and evolution. recent retrospective studies have revealed by cgh-array that the overall genomic pattern is an important prognostic marker which might be taken into account for treatment stratification. this protocol deals with a prospective analysis of the genomic profile established by cgh-array on the tumor samples obtained at the diagnosis of all the patients with nb in france, to obtain genomic profiles and being able to determine their prognostic impact in the various protocols of treatment. the objective of this study will be a better therapeutic stratification in the future trials, studies or protocols of treatment.

after diagnosis of neuroblastoma (nb) or ganglioneuroblastoma : * frozen tumor sample (cell content ≥60%) must be sent for genomic profile determination by cgh-array, * blood sample at diagnosis must be sent to evaluate mycn amplification in plasma, * in case of nb with a mycn amplification, blood sample during treatment and follow-up must be sent.

Eligibility criteria:
inclusion criteria: 1. neuroblastoma or ganglioneuroblastoma defined by inss criteria (brodeur et al. 1993) 2. age \< 18 years 3. availability of tumoral sample obtained at diagnosis, prior chemotherapy with tumor cell content ≥ 60% 4. inclusion in 4 months following the diagnosis 5. all patients treated in french centers (sfce) for neuroblastic tumour, including those participate in national or international protocols. 7. written informed consent 8. patients with french social security in compliance with the french law relating to biomedical research. exclusion criteria: 1. chemotherapy or radiotherapy before taking tumour samples 2. refusal of the parents or the legal representatives
dcs vaccine combined with cytokine-induced killer cells in patients with aml

Conditions: High-risk Soft Tissue Sarcoma

Summary: the aim of this phase ⅰ/ⅱ study is to evaluate the safety and efficacy of dendritic cells (dcs) vaccine combined with cytokine-induced killer (cik) cells in patients with aml. experimental recombinant adenovirus-transfected dcs, which engineered to express muc1 and survivin are used for dcs-based immunotherapy. based on the results of our previously performed preclinical study with dcs vaccine combined with cik cells, the investigators plan to perform the clinical trial.


Eligibility criteria:
inclusion criteria: * consistent with the diagnosis of aml * age≥18 years at time of consent * kps(karnofsky performance scale) ≥70 * patient's written informed consent * no steroid therapy within 4 weeks of first dc vaccination * stable disease, complete response and partial response(who, recist) * predicted survival≥3 months exclusion criteria: * serious dysfunction of vital organs(heart, liver or kidney) * received organ transplantation * patients with other malignancies or brain metastases * history of autoimmune diseases * pregnant and breast-feeding patient * active or chronic infectious diseases * history of allergy or hypersensitivity to study product excipients * currently participating in another clinical trial * received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks * unfit for participating in this clinical trial in investigators' opinions
azacytidine plus flag for relapsed or refractory aml

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this phase 2 study is to test the efficacy of azacytidine given prior to fludarabine, cytarabine, and g-csf for the treatment of relapsed or refractory acute myeloid leukemia.


Eligibility criteria:
inclusion criteria: 1. age 16 to 60 2. patients with a diagnosis of relapse or refractory aml (≥ 20% blast in bone marrow). 3. eastern cooperative oncology group (ecog) performance status ≤2 4. patients must have preserved organ function as defined below: * creatinine ≤ 1.5 mg/dl * total bilirubin ≤ 1.5x upper limit of the normal * alanine aminotransferase (alt) ≤ 2x upper limit of the normal * left ventricular ejection fraction (lvef) ≥ 45% exclusion criteria: 1. patients with a diagnosis of acute promyelocytic leukemia (aml -m3) 2. pregnant women 3. patients previously treated with fludarabine are allowed to participate. 4. patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Keywords: relapsed aml refractory aml azacytidine
intra-articular allocetra in osteoarthritis of the 1st carpo-metacarpal joint

Conditions: Osteoarthritis Thumb

Summary: this study is a single center trial to assess the safety and efficacy of intra-articular administration of allocetra to patients with 1st cmc thumb joint osteoarthritis (oa).

osteoarthritis (oa) of the first carpometacarpal (cmc) joint, or basal joint of the thumb, is a common, painful, and debilitating disease. for patients whose symptoms persist despite conservative therapies and rehabilitation strategies, surgery remains the last-resort treatment. allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. this study is a single center safety and efficacy assessment trial to assess intra-articular administration of allocetra in patients suffering from thumb osteoarthritis in the 1st cmc joint (basal thumb joint) who have not responded sufficiently to conventional therapies. the study is comprised of a safety run-in stage to characterize safety of allocetra injections at different doses, followed by a placebo-controlled double-blind randomized stage to evaluate the safety and efficacy of allocetra injection to the basal thumb joint. patients will be followed for up to a year following treatment.

Eligibility criteria:
inclusion criteria: subjects eligible for this clinical study must fulfill all of the following: 1. age 40 years or older. 2. patients with oa of the first cmc joint of the target thumb (basal thumb joint) who have failed conventional therapies, with pain assessed when not taking analgesic medications. 3. score of 6 or higher on the functional index for hand osteoarthritis (fihoa). 4. x-ray confirming oa of the first cmc joint of the target thumb with a grade of 2 or 3 according to eaton classification. 5. blood tests from up to three months before treatment within protocol-defined limits. exclusion criteria: subjects not eligible for this study include those that have any of the following: 1. any significant injury, fracture, surgery, active local infection, deformity, severe carpal tunnel syndrome (cts), dequervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand. 2. history of chondrocalcinosis in the target joint, concomitant rheumatic disease. 3. previous intra-articular injection of steroid, hyaluronate, or other agent, into the target joint within 3 months prior to screening visit. 4. other limb pain of unknown etiology, or clinically significant widespread pain syndrome, e.g., fibromyalgia. 5. pain in the limb clinically assessed to arise from an origin which is not the affected thumb joint (wrist pain, shoulder pain, etc.). 6. secondary oa such as gout, hemochromatosis, rheumatoid/psoriatic arthritis. 7. bleeding disorders, cognitive disorder, neurologic disease or other major medical condition which may interfere with study participation, treatment, assessments, or results. 8. for women of childbearing potential, a positive pregnancy test.

Keywords: allocetra cell therapy carpo-metacarpal osteoarthritis thumb macrophage
comparison of the strength of maximum glute and medium glutenum muscles of latin and active lombar guidelines

Conditions: Spinal Injuries; Low Back Pain

Summary: contextualization: trigger points are muscle nodules found in muscles. we can observe five different types of trigger point, in clinical practice two of them stand out, the active trigger point; which is painful; and latent; asymptomatic; both of which are sensitive to palpation. once the individual present these muscle nodules can develop pain and motor dysfunction. studies indicate that the prevalence of trigger points is 95% of individuals with chronic musculoskeletal pain, but this prevalence is not yet clear in individuals with low back pain. objective: to compare the pain and function levels of patients with acute and chronic low back pain who, when asymptomatic, had trigger points compared to the pain and function levels of patients with acute and chronic low back pain who, when asymptomatic, had no trigger points. study design: cohort study, two arms, blind evaluator, prospectively enrolled at baseline. location: this research will be conducted in the physiotherapy department at the rehabilitation center of the brotherhood of santa casa de misericórdia de são paulo (iscmsp). patients: 400 asymptomatic individuals follow-up: asymptomatic individuals will be assessed at baseline and over 3 years. you will be asked to contact the research department within 6 weeks of low back pain (acute) and after 12 weeks of low back pain (chronic). participants will be allocated to two groups, trigger point group (n = 200) and group without trigger point (n = 200). outcomes: the pain intensity, function level and trigger point pain intensity outcomes will be evaluated at the baseline, within 6 weeks for the patient to present pain in the lumbar (acute) and after 12 weeks the pain persists (chronic)


Eligibility criteria:
inclusion criteria: * men and women; * age between 18 - 40 years; * asymptomatic; * there is no treatment for lumbar spine, hip or knee. exclusion criteria: * anterior lumbar spine surgeries; * severe spinal diseases (fracture, tumor, ankylosing spondylitis); * root conditions (herniated disc, spondylolisthesis); * congenital malformation; * pregnant women.
use of integra™ flowable wound matrix to manage diabetic foot ulcers

Conditions: Diabetes; Foot Ulcer

Summary: * after determining if subjects meet the criteria to be included in the study they will be randomly placed in either group 1 or 2 and patient will be blinded from randomization group. * subjects will walk across a pressure plate to determine different areas of high pressure under the foot. this will be done before the integra application and at every other follow-up visit. * both groups will be debrided and have pictures taken in the or * group 1 will have integra flowable wound matrix applied onto the wound in the or and group 2 will have the integra flowable wound matrix applied onto the wound and injected subcutaneously in the or. * subjects will be placed in a total contact cast at each visit. if wound healing occurs prior to 12 weeks, a final assessment visit will be done and the status of the healed ulcer will be assessed.


Eligibility criteria:
inclusion criteria: 1. subject is 18 years of age or older 2. subjects with a plantar diabetic foot wound, with or without a previous history of partial foot amputation. 3. subject has diabetes mellitus (type 1 or type 2). 4. university of texas classification 1a with a wound area measurement ranging between 0.3-4.0cm². 5. ability and willingness to understand and comply with study procedures and to give written informed consent prior to enrollment in the study. exclusion criteria: 1. subjects \< 18 years of age 2. subject is non-diabetic 3. subjects who present with wounds of etiology other than diabetes 4. subject demonstrates increased signs of clinical infection 5. has active malignant disease of any kind. a subject, who has had a malignant disease in the past, was treated and is currently disease-free, may be considered for study entry. 6. university of texas classification greater than grade 1a 7. diabetic plantar foot wounds measuring \>4.0cm² 8. subjects who present with significant vascular or metabolic comorbidity that would preclude wound healing 9. subjects participating in any other trials in regards to the diabetic foot ulcer
evaluation of respiratory heast loss as a physiologic patient monitor for acute care medicine

Conditions: Respiratory Heat Loss

Summary: to evaluate the utility of respiratory heat loss measurements as a physiologic monitor.

respiratory heat loss measured in joules per minute

Eligibility criteria:
inclusion criteria: * elective surgical procedures. exclusion criteria: * severe pulmonary disease.

Keywords: enthalpy physiologic monitors critical care medicine
this study aims to quantify decisional regret as well as quality of life in patients with low- to high-risk cancer and high burden of symptoms undergoing radiotherapy using established questionnaires.

Conditions: Quality of Life (QOL); Decision Making ,Shared

Summary: in this prospective registry study, patients with low-, intermediate- and high-risk tumor entities as well as patients with high symptom burden of any tumor entity in palliative constellation with indication for radiation treatment are included. this radiation treatment can be applied either as 3d-conformal rt or igrt. the duration of treatment can range from one day to several weeks. for the primary endpoint as well as the secondary clinical and other exploratory endpoints, the 3 groups will be compared in terms of dr, qol, toxicities and treatment plan parameters

decisional regret and quality of life are quantified and analyzed using general linear models (e.g. linear regression models, anova), taking into account covariates such as tumor stage, application of further systemic therapies, extent of the radiation area, occurrence of acute and/or late side effects. survival time analyses and tumor control rates are evaluated using kaplan- meyer and cox regression. technical endpoints, quality of life and patient satisfaction will be described descriptively and compared between the cohorts using a mixed linear model.

Eligibility criteria:
inclusion criteria: * indication for radiotherapy * patient information and declaration of consent * patients age ≥ 18 years exclusion criteria: * previous radiotherapy in affected site or same localisation in group 1-3 * inability to answer the questionnaires * pre-existing conditions with increased risk of acute or late toxicity (lifraumeni, crohn's disease, ulcerative colitis) * simultaneous participation in other studies that could interfere with this study and/or participation before expiry of a required restriction period * persons who are in a dependent/employment relationship with the investigator

Keywords: decisional regret radiotherapy quality of life
data analysis for drug repurposing for effective alzheimer's medicines (dream) - tocilizumab vs abatacept

Conditions: Rheumatoid Arthritis

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://docs.google.com/spreadsheets/d/1paz3s8atipsh8kyacgxb8gcqqynnk1cv_om79ifiasi/edit?usp=sharing or appendix a for full code and algorithm definitions. medicare timeframe: 2007 to 2017 (end of data availability). inclusion criteria: * 1. no prior use of tocilizumab or abatacept anytime prior to cohort entry date * 2. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. no prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date * 3. prior history of nursing home admission in the 365 days prior to the cohort entry date
resin infiltratration on the sealing of proximal early caries

Conditions: Tooth; Lesion, White Spot Lesions

Summary: material for caries prevention dont have better results compared with non-operatory interventions.

two gruops will be compared. one using icon and another gruop with non-operatory interventions consisted in hygiene instrutions and fluoride topical application. the caries progression will be evalueted with radiographic observation.

Eligibility criteria:
inclusion criteria: * two early caries lesion in the same patient, lesion with the same radiolucencies images exclusion criteria: * pregnancy, use of orthodontics appliences, use of drugs modified salivar flow, ausence of adjacent teeth

Keywords: caries infiltration caries lesion infiltrant
feedback and rewards to increase motivation for therapy in stroke rehabilitation

Conditions: Stroke

Summary: high motivation is a predictor for good therapy results in physical therapy \[grahn 2000\]. the investigator want to show that it is possible to increase patients motivation for stroke rehabilitation by providing them objective performance feedback about the patients therapy progress.

high motivation is a predictor for good therapy results in physical therapy \[grahn 2000\]. additional focus on motivation and rewards has fallen on the topic of stroke rehabilitation since it was shown in an animal model that the brain centers involved with motivation and rewards are crucial to motor learning \[hosp 2011\]. the investigators goal is to target the overall motivation for therapy. during the guided therapy sessions the therapists will be the main motivators and the investigators do not want to interfere with that. but the amount of guided therapy sessions is often limited due to economical reason rather than therapeutic ones. therefore patients are encouraged to do training on their own if possible and to be active during the patients stay in the rehabilitation clinic. the investigators target the patients motivation to train by themselves and be active but also the patients attitude towards the guided therapies. it is known that performance feedback can improve motivation \[harackiewicz 1979\]. therefore the investigators want to use the data about therapy progress to produce feedback for patients visualizing the patients progress and efforts during the patients stay in the clinic. the investigators will compare patients who receive normal therapy to patients who receive normal therapy plus performance feedback regarding a variety of motivation measures.

Eligibility criteria:
inclusion criteria: * first time inpatient at the cereneo rehabilitation clinic exclusion criteria: * rey-figur kopie \<= 25 and rechnerisches denken wie \<=5 * becks depression inventar (bdi) \> 17 * major aphasia preventing understanding of study materials (according to the treating physician).
the effect of core stability training on deep stabilizing muscles.

Conditions: Low Back Pain, Mechanical; Low Back Pain; Low Back Pain, Postural

Summary: non-specific low back pain is the most cause of adult disability throughout life. its prevalence widens in young adults. background of this pathology can be multifactorial. one of the most common is poor core stability and overloading of the local tissues as a result. among treatment methods stabilizing training is commonly used with good effects. this form of therapy affects the transverse abdomen and multifidus muscles. to assess these structures several methods can be applied, e.g. sonofeedback. our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.

non-specific low back pain is the most cause of adult disability throughout life. its prevalence widens in young adults. background of this pathology can be multifactorial. one of the most common is poor core stability and overloading of the local tissues as a result. among treatment methods stabilizing training is commonly used with good effects. this form of therapy affects the transverse abdomen (tra) and multifidus (mf) muscles. to assess these structures several methods can be applied, e.g. sonofeedback. all participants will be randomly divided into two groups: 1. training group (tg) 2. control group (cg) outcome measure: pre- and post-therapy outcome measure will be done. it will include: * ultrasound (sonofeedback) of the tra and mf * oswestry disability index questionnaire (odi) * subjective pain scale - numeric rating scale (nrs) intervention: core stability training including 4 exercise positions, each of 15 repetitions, 4 sets. once a day, 5 times a week, 20 sessions in total (4 weeks). our hypothesis claims that the core muscles morphology will change over the training process duration, in result, the analgesic effect will be achieved.

Eligibility criteria:
inclusion criteria: * low back pain * age from 18 to 30 years old * written consent of the participants exclusion criteria: * injuries of the spine * fractures of the spine * surgery interventions in the spine region prior to the study * psychiatric disorders * neurologic disorders

Keywords: low back pain ultrasound sonofeedback core stability lumbar spine transverse abdomen multifidus