Kornimate/medical-research-clean huggingface dataset:
clinical interest of a genetic diagnosis in early infant epilepsy, paraclinical and therapeutic management, and psychological impact of families

Conditions: Early Infant Epilepsy

Summary: to determine the paraclinical and therapeutic interest of genetic diagnosis in early onset epilepsy.


Eligibility criteria:
inclusion criteria: * children aged ≤ 12 years, * hospitalized or followed at the hautepierre hospital of the university hospitals of strasbourg for primary epilepsy having started in the first 5 months of life, from 2010 to 2021. exclusion criteria: - children with secondary epilepsy (with infection trauma)
single site, single subject, treatment ind with mannkind corporation's technosphere inhalation system

Conditions: Diabetes

Summary: the purpose of this program is to allow patients with diabetes and with specific medical needs which require them to use this investigational inhaled insulin product in order to adequately manage their diabetes. treatment use of this investigational product is only anticipated when exceptional need is identified by a treating physician on a per patient case by case review.

this program is for patients who have been diagnosed with diabetes mellitus and has established a need for treatment with this investigational product documented by a health care professional. the treating doctor, or a member of his/her staff, will discuss the specific requirements for participation with the subject. investigational product description: technosphere® insulin inhalation system includes technosphere® insulin inhalation powder and inhaler. the inhalation powder comes in 10 unit and 20 unit cartridges.

Eligibility criteria:
inclusion criteria: documented diagnosis with diabetes mellitus and have established a need for treatment with the investigational product. local ethics committee approval has been documented, as needed. patient has signed the informed consent form for participation. patient has successfully completed training on the technosphere insulin inhalation system. exclusion criteria: allergy to insulin. smoking in the previous 6-months. history of asthma or copd or any other significant pulmonary disease, or exposure to pulmonary toxins. clinical significant abnormality in screening laboratory tests. positive pregnancy test or the intention to become pregnant. women of childbearing age without appropriate method of contraception.

Keywords: investigational inhaled insulin product
study of atomoxetine in children with adhd to assess symptomatic and functional outcomes

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: the purpose of this study is to assess whether changes in the symptoms of adhd show a relationship with changes in functioning in children with adhd treated with atomoxetine over a 3-month period.


Eligibility criteria:
inclusion criteria: * patients must have adhd, be outpatients, who are at least 6 years of age and not more than 11 years 8 months of age at visit 1 so that all testing will be completed before the child reaches age 12. * patients must have moderately severe symptoms of adhd. * patients must be able to swallow study drug capsules. exclusion criteria: * patients must not have bipolar disorder, psychosis, autism, asperger's syndrome, pervasive developmental disorder, or seizure disorder. * patients must not have taken atomoxetine prior to starting the study.
open lung approach versus standard protective strategies

Conditions: Lung Collapse

Summary: the aim of this study was to compare the effects of adding a recruitment maneuver (rm) to low tidal volume (vt) ventilation, with or without an individualized post-rm positive end-expiratory pressure (peep) setting in lung-healthy patients during anesthesia.


Eligibility criteria:
inclusion criteria: * asa physical status i-iii undergoing elective major abdominal surgery including pancreatic-duodenectomy, gastrectomy and liver resection exclusion criteria: * i) laparoscopic surgery, ii) patients with previous respiratory disease.
xylitol use for decolonization of c. difficile in patients with ibd

Conditions: Inflammatory Bowel Diseases; Clostridioides Difficile Infection

Summary: this is a randomized, placebo-controlled, dose-ranging study to assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of c. difficile in ibd patients. a total of 99 patients who meet eligibility criteria will be randomized 1:1:1 to one of two xylitol doses or placebo arm. all arms will receive an identical capsule dosing for four weeks. microbiome assessment and c. difficile testing will be performed at baseline, week 4, 8, 26, and 52.

this randomized placebo-controlled dose-finding trial will assess the safety and efficacy of xylitol as an oral therapeutic for decolonization of c. difficile in the ibd patient population. participants with confirmed ibd diagnosis who are scheduled for an outpatient colonoscopy for any reason at brigham and women's hospital or clinic appointment at the crohn's and colitis center will be eligible for screening. participants will be screened for c. difficile colonization via colonic wash sampling during colonoscopy or whole stool following a clinic appointment. participants may only have inactive or mild ibd based in clinical scores (see inclusion criteria) to be eligible for screening. risk factors for colonization will be assessed by comparing colonized vs. not colonized patients. participants who are found to be colonized will be randomized 1:1:1 to either placebo or one of two dosing groups of xylitol. the dose a treatment arm will receive 7.5 grams daily of xylitol via gel capsule for 4 weeks. the dose b treatment arm will receive 15 grams daily of xylitol via gel capsule for 4 weeks. the placebo arm will receive identical capsule dosing for 4 weeks. participants will end dosing at week 4, but monitoring will continue through week 52. both participants and study team will be blinded to treatment arm allocation. the primary endpoints assessed are decolonization at week 8 as well as safety and tolerability through week 8. in addition, secondary efficacy outcomes including ibd disease activity and development of cdi, which will be evaluated at week 8, week 26 and week 52. disease activity and symptoms will be recorded from informed consent through the week 52 trial visit. stool samples for biomarker assessments and c. difficile testing will be collected at scheduled trial visits per schedule of assessments.

Eligibility criteria:
inclusion criteria: 1. signed informed consent. 2. male or female ≥ 18 years of age 3. ibd diagnosis (cd, uc or indeterminant colitis will be permitted) 4. inactive or mild ibd (hbi score ≤ 7; partial mayo score ≤ 4) 5. presenting for outpatient colonoscopy or clinic appointment for any indication exclusion criteria: 1. unable to provide consent 2. patients with previous colectomy, ostomy, j-pouch, or previous colon surgery (excluding appendectomy) 3. unable to complete study procedures 4. chronic use of antibiotics 5. inability or unwillingness to swallow capsules 6. allergy to xylitol 7. stool positive for listeria monocytogenes

Keywords: crohn's disease ulcerative colitis
painless synovitis in patients with longstanding rheumatoid arthritis

Conditions: - Rheumatoid Arthritis

Summary: there is a group of patients with rheumatoid arthritis (ra) that suffer from chronically painless synovitis in the hands. the objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (gray-scale and power doppler) findings. a sonographic examination (gray-scale and power doppler) will be done to evaluate metacarpophalangeal joints of patients without local painful and will be a comparison with patients with local painful.

introduction/objectives: there is a group of patients with rheumatoid arthritis (ra) that suffer from chronically painless synovitis in the hands. the mean of this is still unknown and does not exist studies in the literature that assessing the predictors of this behavior or synovial potential to cause bone erosion. the objective of this study is to compare painless synovitis (called "cold" synovitis) with painful synovitis according to the sonographic (gray-scale and power doppler) findings, articular damage (x-ray and sonography), clinical, laboratory and demographic variables in ra patients. methods: cross-sectional study with ra patients, which will be evaluated metacarpophalangeal joints of patients without local painful. sixty ra patients will be selected in the federal university of são paulo ambulatory (unifesp). the patients will be divided in two groups of thirty patients each: "painless synovitis" group and "painful synovitis" group. all patients will be measured through clinical evaluation, hands ultrasound and laboratory parameters (erythrocyte sedimentation rate, esr; rheumatoid factor, rf; anti-cyclic-citrullinated peptide antibodies, ccp) on the same day. the clinical evaluation will be measured by a trained rheumatologist with experience in joint physical examination (synovitis). this measure will be done before the sonography examination and the assessment tools will be: painful joint count; swollen joint count; painful visual analogue scale (vas 0-10); swollen vas; activity disease vas; measurement of grip strength and pinch with jamar dynamometer and preston pinch gauge; 28 joint disease activity score (das 28); stanford health assessment questionnaire (haq); cochin hand functional scale (chfs) and patient clinical evaluation. the level of statistical significance will be 5%.

Eligibility criteria:
inclusion criteria: * longstanding rheumatoid arthritis * chronically painless synovitis in the hands or painful exclusion criteria: * uncompensated systemic disease, e.g. diabetes mellitus, hypothyroidism * change of basic drug in the last 3 months
trial for locally advanced breast cancer using vorinostat plus chemotherapy

Conditions: Breast Cancer

Summary: vorinostat is a histone deacetylase (hdac) inhibitor which is approved by the u.s. food and drug administration for the treatment of a rare type of cancer involving the skin (cutaneous t cell lymphoma), but not for breast cancer. hdac inhibitors work by unsilencing tumor suppressor genes and other genes in the cancer cells that are repressed; when the genes are turned back on by the drug, it leads to death of the cancer cells. hdac inhibitors such as vorinostat have been shown to enhance the effects of chemotherapy and trastuzumab in experimental systems. the purpose of this trial is to determine the optimal dose of vorinostat to use in combination with standard chemotherapy alone (or in combination with plus trastuzumab for her2-positive disease), and to determine whether vorinostat enhances the effectiveness of standard chemotherapy (+/- trastuzumab) in patients with locally advanced breast cancer.

this is a phase i-ii trial in which patients with stage iib-iiic breast cancer will receive: 1. neoadjuvant weekly paclitaxel (80 mg/m2 iv weekly x 12 weeks) plus vorinostat (200 or 300 mg po bid on days 1-3 each paclitaxel dose) and trastuzumab (4 mg/kg loading dose, 2 mg/kg iv weekly x 12 total doses if her2 positive, followed by: 2. doxorubicin (60 mg/m2) plus cyclophosphamide (600 mg/m2) every 2 weeks x 4 cycles (plus g-csf), followed by: 3. surgery (lumpectomy or mastectomy)

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma of the breast associated with the following stages: iib, iiia, iiib or iiic. * tumor must be her2/neu positive * no prior chemotherapy, radiation or definitive therapeutic surgery exclusion criteria: * may not be receiving any other investigational agents * uncontrolled intercurrent illness

Keywords: vorinostat neoadjuvant chemotherapy
lower extremity proprioception sensory and functionality in hemiparetic

Conditions: Hemiparesis Proprioceptive Disorders Gait, Hemiplegic, Healthy Individual, Comparative Study

Summary: the loss of sensorial feedback causes gait impairment in hemiparesis. the studies show that proprioceptive impairment of knee is related to falling in these patients. the aim of this study is to investigate the effects of proprioception on balance and gait functions in hemiparetic individuals.


Eligibility criteria:
inclusion criteria: * between the ages of 20-65 and discharged from the hospital, * diagnosed with hemiparesis at least 4 weeks ago, * first time and unilateral hemiparesis, * modified rankin score ≤ 3, * hodkinson mental test ≥ 6, * individuals who agree to receive treatment will be included in the study. exclusion criteria: * having vision and hearing problems, * having other accompanying neurological, psychiatric and/or orthopedic problems other than hemiparesis, * medically unstable, * diseases that will affect the lower extremity sense, * individuals with open wounds, circulation problems, and skin lesions in the area to be treated will be excluded from the study.
regional fatty acid metabolism in humans

Conditions: Diabetes Mellitus, Type 2

Summary: there are several studies looking at how dietary fat is metabolized by humans. we give special meals and collect blood, breath, urine and fat samples to study how people burn and store dietary fat.


Eligibility criteria:
inclusion criteria: bmi\<25 lean, sedentary with family history of dm2 and lean, sedentary without family history of dm2 and lean, active without family history of dm2. non-smokers. exclusion criteria: known systemic illness, cardiac and vascular disease and bp\> 160/95 on htn meds. medications that affect fat metabolism. we do not pay for travel expenses.

Keywords: type 2 diabetes some studies - family history of type 2 diabetes
brain computer interface training after stroke

Conditions: Stroke

Summary: in this study, we want to examine the effect of a new treatment approach for patients with severe upper limb paresis in the subacute phase after stroke. brain computer interface (bci) driven functional electrical stimulation will be compared to conventional training.

a randomized controlled pilot study will be conducted. forty patients with severe ul paresis will be included. patients with severe hemiparesis after stroke will be allocated to one of two treatment groups by a computerized randomization program. patients in the intervention group will receive training with a bci system paired with functional electrical stimulation and visual feedback (recoverix, gtec, austria) as part of their rehabilitation. the targeted number of training sessions in the intervention group is 12. patients in the control group will receive conventional upper limb training. all patients will receive other rehabilitation according to their needs. patients will be assessed by blinded raters before and after the intervention and 3 months post stroke. main endpoint will be ul motor function assessed by action research arm test (arat) at 3 months post stroke. other outcome measures comprise fugl meyer motor assessment and functional independence measure. the patients and therapists' experience with this type of training will be evaluated with questionnaires and interviews.

Eligibility criteria:
inclusion criteria: * first ever or former stroke without ul motor residuals as confirmed by ct and / or mri * 15 days to 60 days (+/- 3) after stroke onset * severe paresis or paralysis defined as \< 13 on action research arm test (arat) * able to give informed consent * able to comply with treatment protocol. exclusion criteria: * other conditions limiting functional use of the affected ul, * psychiatric / behavioral conditions that interfere with compliance to the protocol, epilepsy

Keywords: bci upper limb severe paresis subacute stroke rehabilitation
changes in cerebral oxygenation during deliberate hypotensive anesthesia

Conditions: Hypotension

Summary: this is a study using cerebral oximetry to evaluate the safety of traditionally adopted hypotensive anesthesia.

the values of cerebral oximetry were analyzed between different stages of anesthetic management. the critical part of anesthetic management is to use the technique of controlled hypotension. the blood pressure was lowered to the level of mabp 50 or 60 mmhg depending on which group patients were assigned to. the values of cerebral oximetry and side effects between 2 groups will be compared at the completion of data collection.

Eligibility criteria:
inclusion criteria: * 40 patients are going to receive complex spine surgery. exclusion criteria: * neurologic diseases * hepatic or renal impairment * uncontrolled hypertension * cardiovascular diseases

Keywords: controlled hypotension
trial of chinese prescription on ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate the efficacy and safety of the chinese prescription on ulcerative colitis.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of ulcerative colitis * male of female patients between 18-65 years old * written informed consent exclusion criteria: * combine with malignant pathology on epithelial dysplasia of mucosa * combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease. * pregnancy or breast feeding women, or unwilling to have contraception.

Keywords: alternative medicine traditional chinese medicine
meibomian gland dysfunction (mgd) and tear cytokines after cataract surgery according to preoperative meibomian gland status

Conditions: Cataract

Summary: to investigate the possible mechanisms by which cataract surgery aggravates meibomian gland dysfunction (mgd), the investigators evaluated the changes in tear cytokines and ocular surface parameters after cataract surgery according to the preoperative mgd grade.


Eligibility criteria:
inclusion criteria: * males or non-pregnant females aged between 55 to 80 years-old. exclusion criteria: * had a history of ocular diseases, such as ocular infection, ocular allergy, and autoimmune disease, as well as patients with continuous use of topical ocular medications before surgery, or histories of ocular surgery or ocular injury.
post marketing observational study on safety of balfaxar vs. kcentra for reversal of vitamin k antagonist induced anticoagulation in adults undergoing urgent surgery or invasive procedure

Conditions: Vitamin K-Dependent Coagulation Defect; Significant Bleeding Risk

Summary: post marketing observational study on safety of balfaxar vs. kcentra for reversal of vitamin k antagonist induced anticoagulation in adults undergoing urgent surgery or invasive procedure


Eligibility criteria:
inclusion criteria: 1. subjects at least 18 years of age. 2. subjects on vka treatment. 3. received 4f-pcc agent, balfaxar or kcentra, for urgent reversal of within 48 hours prior to urgent surgery or invasive procedure. exclusion criteria: 1. history of tee within 90 days before receipt of vka reversal therapy. 2. subjects treated with vka reversal therapy and not undergoing urgent invasive procedure.
neural therapy and kinesio taping effectiveness in fibromyalgia

Conditions: Fibromyalgia

Summary: the aim of this study; to investigate the effects of neural therapy and kinesio taping treatments on pain, functional status and quality of life in women with fibromyalgia.

fibromyalgia is a chronic disorder characterized by widespread pain, fatigue, sleep disturbance, cognitive impairment, and other physical symptoms that negatively affect physical and sensory functions and impair quality of life. neural therapy and kinesio taping are treatments for musculoskeletal diseases. in this prospective, randomized controlled, double-blind, interventional study, 64 patients aged 18-55 years who met the eligibility criteria will be included in the study. eligible participants will be randomly assigned to one of two groups using computer generated random numbers. segmental neural therapy and sham kinesio taping will be applied to the first group. in the second group, kinesio taping with inhibition technique will be applied to bilateral trapezius and erector spina muscles and sham neural therapy will be added. treatments will be applied once a week for a total of 6 weeks. both groups will be given a home exercise program consisting of stretching exercises and will be checked every week. during the follow-up period, patients will be asked not to make changes to their current medical treatment. participants will be evaluated for pain by visual analogue scale (vas), fibromyalgia impact questionnaire (fiq), central sensitisation inventory (csi), beck depression inventory (bdi), beck anxiety inventory (bai), health assessment questionnaire (haq), short form-36 (sf-36), manual algometer measurements and number of tender points, as well as post-treatment and post-treatment 3 month control data.

Eligibility criteria:
inclusion criteria: * to be diagnosed with fibromyalgia according to the acr 2016 diagnostic criteria. * being a woman between the ages of 18 and 55. * no change in the medical treatment he received for fibromyalgia syndrome during the study * to be able to come to treatment 1 day a week for 6 weeks exclusion criteria: * presence of known central nervous system or peripheral nervous system disease, progressive neurological deficit * peripheral venous insufficiency, coagulopathies and anticoagulant drug use * loss of sensation, loss of position sense, unhealed fracture or open surgical wound * uncontrolled hypertension and uncontrolled diabetes * be in major depression * cognitive impairment that causes difficulty following simple commands * pregnancy * be in menopause * allergy to local anesthetics and kinesio taping * open wound or infection at the application site

Keywords: fibromyalgia neural therapy kinesio taping