Kornimate/medical-research-clean huggingface dataset:
gaining optimism after weight loss surgery (goals) i

Conditions: Bariatric Surgery

Summary: this study examines the feasibility, acceptability, and preliminary impact of an adapted positive psychology-motivational interviewing (pp-mi) intervention for physical activity among patients who have recently undergone bariatric surgery.

this study will test a positive psychology-motivational interviewing (pp-mi) intervention for physical activity promotion in patients who have had bariatric surgery within the past 6-12 months. the investigators will enroll 12 participants. study participation includes attending three study visits (two at baseline, one after the intervention) and receiving a 10-week physical activity intervention that includes once-weekly phone calls, a written manual, and a fitbit activity tracker. primary outcomes are feasibility and acceptability of the intervention and study procedures. secondary outcomes include pre-post changes in physical activity and other psychological, behavioral, and physiological outcomes.

Eligibility criteria:
inclusion criteria: * adult (age 18+) * history of bariatric surgery (gastric bypass or sleeve gastrectomy) at one of two academic medical centers within the past 6-12 months * interest in increasing physical activity * low physical activity, defined as \<200 minutes/week self-reported moderate- to-vigorous physical activity * access to telephone for study sessions * able to read and speak english exclusion criteria: * cognitive deficits precluding participation or informed consent * illness likely to lead to death in the next 6 months * inability to be physically active (e.g., severe arthritis) * participation in another program targeting physical activity besides their standard offerings at the surgery center.

Keywords: positive psychology motivational interviewing physical activity
injury prevention programs in overhead athletes

Conditions: Healthy; Shoulder Impingement Syndrome; Shoulder Injury; Shoulder Pain Chronic; Shoulder Joint Limitation; Shoulder Flexibility

Summary: to evaluate and describe the effect of performing an integrated injury prevention exercises on the variables considered as injury risk factors in overhead athletes

to evaluate and describe the effect of performing fast or 6-8 weeks injury prevention programs on the variables considered as injury risk factors in overhead athletes as glenohumeral rotational range of motion or muscle activation pattern and asymmetries.

Eligibility criteria:
inclusion criteria: * signing the informed consent according last version ogf helsinky declaration. * be involved in a overhead sport for a minimum of 2 years. exclusion criteria: * have some pain or disconfort to develop the outcome measurements

Keywords: injury prevention glenohumeral rotation deficits overhead athletes shoulder pain shoulder instability shoulder mobility shoulder exercises shoulder symetries shoulder asymetries shoulder stability shoulder strength escapulahumeral complex
a phase 3 study of brentuximab vedotin (sgn-35) in patients at high risk of residual hodgkin lymphoma following stem cell transplant (the aethera trial)

Conditions: Disease, Hodgkin

Summary: this is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (sgn-35) and best supportive care (bsc) compared to placebo and bsc in treatment of residual hodgkin lymphoma (hl) following autologous stem cell transplant (asct).


Eligibility criteria:
inclusion criteria: * patients with hl who have received asct in the previous 30-45 days * patients at high risk of residual hl post asct * histologically-confirmed hl * ecog of 0 or 1 * adequate organ function exclusion criteria: * previous treatment with brentuximab vedotin * previously received an allogeneic transplant * patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to asct * history of another primary malignancy that has not been in remission for at least 3 years * post asct or current therapy with other systemic anti-neoplastic or investigational agents

Keywords: antigens, cd30 antibody-drug conjugate antibodies, monoclonal disease, hodgkin drug therapy hematologic diseases immunotherapy lymphoma monomethylauristatin e
efficacy and safety of eltrombopag + tacrolimus in chinese refractory or relapsed aplastic anemia patients

Conditions: Aplastic Anemia; Drug Effect

Summary: this is a randomized, open-label, phase ii study to compare the efficacy of eltrombopag combined with tacrolimus to eltrombopag alone in chinese subjects with refractory or relapsed aplastic anemia. the safety would also be evaluated. patients would be randomized to receive eltrombopag alone or eltrombopag combined with tacrolimus. treatment with eltrombopag will be started at 25 mg/day and increased by 25 mg/day every 2 weeks according to the platelet count up to 150 mg/day, or the best response was achieved. tacrolimus will be given at 1mg bid with the target trough concentration of 4-10 ng/ml throughout the study. the hematological response rate and safety will be recorded and compared at 3, 6 months and 1 year after starting the study treatment (week 13, 26 and 52).


Eligibility criteria:
inclusion criteria: 1. patient with a previous diagnosis of aplastic anemia and had no response or relapsed following at least one treatment course in a period time of ≥ 6 months of immunosuppression containing csa or csa+anti-thymocyte globulin (atg); 2. current diagnosis of aplastic anemia by bone marrow biopsy; 3. did not receive hsct nor were hsct candidates; 4. patient has an eastern cooperative oncology group (ecog) performance status 0-2; 5. patient with qtcf (fridericia's qt correction formula) at screening \<450 msec, or \<480 msec with bundle branch block, as determined via the mean of a triplicate ecg and assessed at site. 6. subjects are able to understand and comply with protocol requirements and instructions and have signed and dated informed consent. exclusion criteria: 1. congenital aplastic anemia; 2. presence of chromosomal aberration; 3. evidence of a clonal hematologic bone marrow disorder on cytogenetics; 4. have any concomitant malignancies and must be fully recovered from treatment for any other malignancy and have been disease-free for 5 years; 5. ast or alt ≥3 times the upper limit of normal; 6. serum creatinine, total bilirubin, or alkaline phosphatase \>1.5 x uln; 7. cardiac disorder (nyha) functional classification grade ii/iii/iv; 8. past history of thromboembolic event (including anti-phospholipid antibody syndrome) and current use of anticoagulants; 9. infection not adequately responding to appropriate therapy; 10. other known or suspected underlying primary immunodeficiency; 11. prior treatment with eltrombopag, romiplostim, or any other tpo (thrombopoietin) receptor agonist; 12. pregnant or nursing (lactating) woman;
glucose tolerance in patients with an idiopathic parkinson's disease

Conditions: Parkinson's Disease

Summary: dysfunction of autonomic nervous system is an important non motor feature of parkinson' disease (pd). lewy body formation is widely distributed in hypothalamus and in sympathetic and parasympathetic systems. animal studies suggest a link between hypothalamus sensing of substrates and glucose metabolism. thus, hypothalamus lesions could lead to change in glucose metabolism. recently, we showed that fasting blood glucose level was significantly higher in pd patients than in control group suggesting that glucose tolerance may be impaired in pd. some studies provided evidence for higher diabetes prevalence in pd patients whereas others showed no difference or a reduced risk of diabetes prevalence in pd patients compared to healthy subjects. so, the risk that a pd patient develops a glucose intolerance or a diabetes is not clearly established and merit to be studied considering the damageable consequences for patient healthy. the aim of this prospective study was to determine the risk that a pd patient develop a glucose intolerance or a diabetes compared to a matched control group, using an oral glucose tolerance test (ogtt).

50 patients inclusion visit : * clinical examination/ interview on health and medical history * complete updrs, mms * biologic check up protocol : all patients were studied in the postabsorptive state after a 10-h overnight fast. on the day of the experiment, patients did not receive their treatment. one catheter was inserted for blood sample collections. patients ingested then 75 g of glucose. blood samples were collected for plasma glucose and plasma insulin concentration analyses at t0, t30, t60, t90, t120, t150 and t180. urinary glucose was researched at t0 and t120. in parallel, a dysautonomia evaluation of each patient was made (scopa aut questionnaire, tilt test).

Eligibility criteria:
inclusion criteria: * age : 18-70 years * patient with an idiopathic parkinson's disease according to the criteria of the "parkinson's disease society brain bank" with a duration of disease \>5years * mms\>24/30 * no treatment modification 7 days before the inclusion * affiliation to social security * agreement of patients exclusion criteria: * patient treated with antibiotics, ains, ais or other treatment which could interfere with the protocol * patients with significant heart, respiratory, psychiatric, metabolic, hepatic, kidney diseases; diabetes, heart deficiency, chronic kidney deficiency, untreated thyroid disease ... * patient treated with a deep brain stimulation * patients with metabolic and/or biological anomalies * pregnant women * medical or chirurgical previous history which could interfere with the protocol * alcohol (\>30g/day); tobacco (\>10 cigarettes/day) * participation to an other study at the same time

Keywords: idiopathic parkinson's disease glucose intolerance diabetes ogtt patient with an idiopathic parkinson's disease
effect of nutrition supplementation combined with resistance exercise in elderly with sarcopenia.

Conditions: Sarcopenia

Summary: the purpose of this study was determine whether milk or soy milk supplements combined with resistance exercise improved sarcopenia in the elderly. this study was randomized controlled trail that recruited elderly people ≧65 years old with sarcopenia in the nursing home of taipei veterans general hospital su-ao and yuanshan branch from june 2017 to december, 2017. the participants were divided into three groups, such as control, milk supplement and soy milk supplement. the milk and soy milk groups provided 200 ml milk or soy milk two times per day. moreover, all participants joined the resistance exercise training program, three times per week (30 min/time). after 12 weeks, the anthropometry, sarcopenia index, blood biochemical index, nutrition status index, inflammation index, insulin resistance index, and dietary intake were measured.

the anthropometry data included body weight and body fat. the sarcopenia index included appendicular skeletal muscle mass index, calf circumferences, hand grip and gait speed. moreover, blood biochemical index (liver function as alt, kidney function as creatinine), nutrition status index (prealbumin, 25-hydroxyvitamin d) were also analyzed. the blood hscrp level was as inflammation index and insulin resistance index included fasting blood sugar, insulin, hba1c and homa-ir. the daily dietary intake were also recorded.

Eligibility criteria:
inclusion criteria: * age ≧ 65 years old * no allergies to milk and soy milk * sarcopenia cases (awgs) * active ability exclusion criteria: * end-of-life patient or estimated death within six months * last stage of cancer * chronic kidney disease stage 4

Keywords: sarcopenia milk soy milk resistance exercise
phase iib safety and efficacy study of different oral doses of bay94-8862 in subjects with worsening chronic heart failure and left ventricular systolic dysfunction and either type 2 diabetes mellitus with or without chronic kidney disease or chronic kidney disease alone

Conditions: Heart Failure

Summary: to assess a new drug, bay94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type ii diabetes with or without chronic kidney disease or kidney disease alone. these treatment doses were compared to eplerenone, another marketed drug approved to treat heart failure.


Eligibility criteria:
inclusion criteria: * men and women aged 18 years and older. the lower age limit may be higher if legally required in the participating country * women of childbearing potential can only be included in the study if a pregnancy test is negative and if they agree to use adequate contraception when sexually active * subjects with worsening chronic heart failure requiring emergency presentation to hospital and treatment with intravenous diuretics at hospital * subjects with clinical diagnosis of chronic heart failure (chf) either ischemic or non ischemic, new york heart association (nyha) functional class ii-iv * subjects with type 2 diabetes mellitus and / or * subjects with 30 ml/min/1.73m\^2 \</= egfr \</= 60 ml/min/1.73m\^2 (mdrd, modification of diet in renal disease study group) at screening * left ventricular ejection fraction (lvef) \</= 40% * blood potassium \</= 5.0 mmol/l at screening * systolic blood pressure \>/= 90 mmhg without signs and symptoms of hypotension at the screening visit exclusion criteria: * acute de-novo heart failure or acute inflammatory heart disease, e.g. acute myocarditis * acute coronary syndrome (acs) in last 30 days prior to screening * cardiogenic shock * valvular heart disease requiring surgical intervention during the course of the study * stroke or transient ischemic cerebral attack in the last 3 months prior to the screening visit * concomitant treatment with any mineralocorticoid receptor antagonist (mra), renin inhibitor, or potassium-sparing diuretic

Keywords: heart decompensation
postoperative pain therapy with hydromorphone tci-pca vs. morphine pca

Conditions: Acute Postoperative Pain

Summary: treatment of postoperative pain with hydromorphone (a strong analgesic) using patient-controlled analgesia with target-controlled infusion compared to conventional patient-controlled analgesia with morphine after elective cardiac surgery


Eligibility criteria:
inclusion criteria: * written informed consent * scheduled for elective cardiac surgery involving thoracotomy and subsequent icu stay exclusion criteria: * administration of other analgesics or sedatives, if not administered in stable dosages for at least 14 days or if not used for premedication and surgery * administration of hydromorphone or morphine in the period between screening and surgery * severe hepatic or renal impairment in medical history * bmi\>= 35 asa\>= 4
mr scanning of very young children with severe developmental disorders

Conditions: Autism; Mental Retardation; Language Disorder

Summary: the specific is to study the mr morphologic and spectroscopic brain correlates and predictors of development in children with severe developmental disorders (autistic spectrum disorders and/or mental retardation and/or language disorders). given the frequently observed association of autism with known medical conditions, particularly in cases with comorbid mental retardation and in cases with atypical autism (rutter et al., 1994; gillberg, 1995), children with suspected autism or related developmental disorders will be asked to participate in an extensive state of the art laboratory work-up which includes t1 and t2 weighted mri of the brain. mri data will be analyzed both qualitatively, looking for focal abnormalities and degree of myelination, and quantitatively, measuring volumes of total brain, cerebellum, ventricles and grey and white matter. for research purposes, the work-up will be supplied with proton magnetic resonance spectroscopy (mrs) of the brain. this data set provides the opportunity to chart brain-behavior relationships in young children with suspected autism and related pdd cross-sectionally.


Eligibility criteria:
inclusion criteria: * age 18 months to 7 years * diagnosis of autism spectrum disorder, a language disorder or mental retardation exclusion criteria: * significant motor or sensory impairment * major physical abnormalities * history of serious head injury * identifiable neurologic disorder * metal implants * contraindication for mri

Keywords: autism mri developmental disorders
neuron-specific humoral and cellular immune correlates of structural and functional brain connectomics in neuropsychiatric lupus

Conditions: Systemic Lupus Erythematosus

Summary: systemic lupus erythematosus (sle) is the prototype systemic autoimmune disease. neuropsychiatric sle (npsle) is a major cause of morbidity. its pathophysiology remains unclear and target autoantigens have not yet been identified. site- specific autoantigen expression might correlate with imaging abnormalities. based on existing expertise on the use of peptide/protein arrays and on antigen-specific t cell tracking, we plan to identify new fingerprints and targets for npsle. sle patients +/- npsle and healthy subjects will undergo advanced magnetic resonance imaging. three-dimensional data on structural or functional brain architecture will be integrated with brain transcriptome atlases and candidate antigens for autoreactive autoantibodies and t lymphocytes identified and validated. the evidence will add to current knowledge on npsle pathophysiology, provide new multimodal diagnostic tools for better patient care and a platform for innovative, personalized treatments.


Eligibility criteria:
inclusion criteria: patients with sle * diagnosis of sle according to the acr 1997, slicc 2012 or eular/acr 2019 criteria * age ≥ 18 years (reference centre) * age 15-17 years (affiliated centre) healthy subjects * charlson's comorbidity index=0 and no chronic treatment * age ≥ 18 years (reference centre) * age 15-17 years (affiliated centre) exclusion criteria: * history of t-cell neoplasia * active b-cell neoplasia or history of b-cell neoplasia of less than five years * contraindications to mri * pregnancy * ongoing or past treatment with t-depleting agents * history of brain cancer * history of congenital brain disorders * cerebral disorders secondary to trauma, toxins or other metabolic or environmental factors unrelated to sle according to the investigator's evaluation * any other condition conferring excessive physical and psychological risk to the subject according to the investigator's opinion
avalglucosidase alfa pregnancy study

Conditions: Pompe Disease; Pregnancy

Summary: this is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal complications and adverse effects in the developing fetus, neonate, and infant. * outcomes in exposed infants, including growth and development, will be assessed through at least the first year of life. * data will be collected for approximately 10 years.

study design time perspective: retrospective and prospective

Eligibility criteria:
inclusion criteria: * women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation for whom an individual case safety report (icsr) has been submitted to the sanofi global pharmacovigilance (pv) department, and/or, * women exposed to avalglucosidase alfa during pregnancy and/or lactation who have provided informed consent to enroll in the pompe pregnancy sub-registry. exclusion criteria: there are no exclusion criteria in this study. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
hyperoxemia and ventilator-associated pneumonia

Conditions: Mechanical Ventilation

Summary: the aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (vap) occurrence. * spo2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia. * patients with vap will be prospectively identified. * patient characteristics and risk factors for vap will be prospectively collected. * oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (gpx), plasmatic superoxyde dismutase (sod), total plasmatic antioxidant status (sat) and urinary 8-isoprostanes will be performed at icu admission, once a week, and at vap occurrence. patients with vap will be compared with those with no vap


Eligibility criteria:
inclusion criteria: * adult patients admitted to the icu * expected duration of mechanical ventilation \> 48h * signed informed consent * social insurance exclusion criteria: * pregnancy or breast feeding * no informed consent * hyperbaric oxygen treatment * prisoners and patients under guardianship

Keywords: hyperoxemia ventilator-associated pneumonia critical illness
study of the golimumab exposure-response relationship using serum trough levels

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to gain insight into the exposure-response relationship of golimumab in moderate-to-severe ulcerative colitis (uc). patients commencing induction therapy with golimumab will be enrolled into a prospective study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical uc disease activity as well as serum golimumab concentrations and the presence of anti-golimumab antibodies. patients already established on stable golimumab maintenance therapy will be enrolled into a cross-sectional study with the same evaluations taken at a single time point.

the study will involve two study groups designed to offer insights into the pharmacokinetics of golimumab during induction and maintenance therapy: cohort 1: patients commencing golimumab induction therapy will be included in a prospective, observational study. cohort 2: patients receiving golimumab maintenance therapy will be included in a cross-sectional, observational study. primary objective: to define a week 6 serum golimumab concentration that predicts response at week 14. secondary objective: to define serum golimumab concentrations at weeks 6, 10 and 14 that predict response at each time point, respectively and at week 14. exploratory objectives: correlations between serum golimumab concentrations and novel disease activity indices (pro2), biochemical markers of disease activity (crp, faecal calprotectin) and quality of life indices (ibd-q and ibd-control). correlations between the presence of anti-golimumab antibodies, serum golimumab concentrations and uc disease activity. this study will also generate data that can be used to validate a commercially available golimumab assay as well as a novel patient reported outcome (pro) assessment of clinical uc disease activity.

Eligibility criteria:
inclusion criteria for cohort 1: * aged 18 years or over * moderate-to-severe uc, defined as: sccai \> 5 and, i. a raised fecal calprotectin (\> 59 μg/g) or, ii. a raised crp (\> 5 mg/l) or, iii. endoscopic disease activity mayo 2 or above, evaluated within 4 weeks of study enrollment * commencing golimumab treatment * written informed consent to participate * sufficient english language skills to understand the patient information sheet and consent form inclusion criteria for cohort 2: * aged 18 years or over * receiving golimumab treatment for uc for over 18 weeks (6 injections) * written informed consent to participate * sufficient english language skills to understand the patient information sheet and consent form exclusion criteria (cohort 1 only): * contra-indication to golimumab: tuberculosis or severe infections * imminent need for colectomy (i.e. colectomy is being planned) * previous primary non-response to anti-tnf therapy in the opinion of the investigator * previous treatment with more than one anti-tnf therapy (excluding golimumab)