Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of golimumab in pediatric participants with moderately to severely active ulcerative colitis

Conditions: Colitis, Ulcerative

Summary: the purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the mayo score, in pediatric participants with moderately to severely active ulcerative colitis (uc). in addition, the safety profile of golimumab, in pediatric participants with moderately to severely active uc will be assessed.


Eligibility criteria:
inclusion criteria: * must either be currently receiving treatment with, or have a history of having failed to respond to, or have a medical contraindication to at least 1 of the following therapies: oral or intravenous corticosteroids, 6-mercaptopurine, methotrexate or azathioprine or must either have or have had a history of corticosteroid dependency (that is an inability to successfully taper corticosteroids without a return of the symptoms of ulcerative colitis \[uc\]) or required more than 3 courses of corticosteroids in the past year * moderately to severely active uc (as defined by baseline mayo score of 6 through 12 \[endoscopy {sigmoidoscopy or colonoscopy} sub score assigned by local endoscopist\], inclusive), including a (sigmoidoscopy or colonoscopy) sub score greater than or equal to (\>=2) * if receiving enteral nutrition, must have been on a stable regimen for at least 2 weeks prior to the first administration of study intervention at week 0. participants who receive parenteral nutrition are not permitted to enroll in the trial * no history of latent or active tuberculosis prior to screening * must be up to date with all immunizations (that is, measles, mumps, rubella, and varicella) in agreement with current local immunization guidelines for immunosuppressed participants before week 0 exclusion criteria: * history of liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric (including suicidality), or metabolic disturbances * history of malignancy or macrophage activation syndrome or hemophagocytic lymphohistiocytosis * have uc limited to the rectum only or to \<20 percent (%) of the colon * presence of a stoma * presence or history of a fistula * contraindications to the use of golimumab or infliximab or anti-tumor necrosis factor (tnf-alpha) therapy per local prescribing information
optic nerve sheath diameter in craniosynostosis

Conditions: Optic Nerve Sheath Diameter

Summary: changes of optic nerve sheath diameter after position changes

changes of optic nerve sheath diameter after position changes from supine to prone position in children for craniosynostosis

Eligibility criteria:
inclusion criteria: * craniosynostosis exclusion criteria: * infection on eye area
using clonidine to improve leg weakness in people with heart failure

Conditions: Heart Failure

Summary: people with heart failure often have weakness in their leg muscles. this study will determine whether the leg weakness is due to very high adrenaline levels and whether the medication clonidine can improve leg weakness.

heart failure is a common condition, affecting approximately 5 million people in the united states. people with heart failure are encouraged to exercise and lose weight. however, many people with heart failure develop weakness in their leg muscles, which can make exercise difficult. increased sympathetic nerve activity, which involves the nerves that carry adrenaline, also occurs in people with heart failure. it is possible that the increased sympathetic nerve activity may actually cause the leg muscle weakness. clonidine, a medication used to treat high blood pressure, has been found to decrease sympathetic nerve activity. this study will further examine the connection between leg weakness and sympathetic nerve activity. it will also evaluate the effectiveness of clonidine at decreasing leg weakness in people with heart failure. results from this study may explain why some people with heart failure are unable to exercise and may help to identify ways in which leg strength can be increased. this study will enroll people with heart failure. participants will be randomly assigned to wear either a clonidine patch or a placebo patch for 3 months. participants will wear the patch on their upper arm, and they will replace the patch each week. at study visits at baseline and month 3, participants will undergo the following procedures: * sympathetic nerve activity recording, which will record nerve activity in the lower leg, using small electrodes inserted through the skin * muscle biopsy, in which a small piece of muscle tissue will be obtained from participants' legs * heart rate and blood pressure measurements * arterial baroreceptor measurements, in which the nerves in the body that respond to changes in blood pressure will be examined while participants receive different medications to increase and decrease their blood pressure * echocardiography to obtain images of the heart * magnetic resonance scan of the leg * passive exercise procedure, in which study researchers will conduct an arm exercise with participants there will be no follow-up visits.

Eligibility criteria:
inclusion criteria: * heart failure exclusion criteria: * currently on coumadin therapy * experienced a heart attack in the 3 months before study entry * medically unable to receive clonidine * advanced kidney or liver disease

Keywords: leg weakness skeletal myopathy sympathetic nerve activity
develop and evaluate the effectiveness of a self-care smartphone application on the self-efficacy, and resilience among newly diagnosed breast cancer patients undergoing treatment

Conditions: Breast Cancer; Breast Neoplasm; Breast Malignant Tumor; Resilience; Self-efficacy

Summary: this study was to develop and evaluate the self-efficacy and resilience of the breast cancer self-care app in newly diagnosed breast cancer patients undergoing chemotherapy.

this study was to develop and evaluate the self-efficacy and resilience of the breast cancer self-care app in newly diagnosed breast cancer patients undergoing chemotherapy. in the first phase of this study, develop a prototype the breast cancer self-care app by conducting patients interviews. in the second phase, an experimental two-group pretest-posttest quantitative study design to evaluate the self-efficacy and resilience of the breast cancer self-care app in newly diagnosed breast cancer patients undergoing chemotherapy. the patients were randomized to the experimental and control groups. patients in the control group received general routine care and patients in the experimental group received general routine care plus the breast cancer self-care app intervention. both groups completed a basic demographics, self-efficacy and resilience questionnaires at the pre-test and after four weeks.

Eligibility criteria:
inclusion criteria: * consciousness clear, over 20 years old, can communicate in mandarin and taiwanese * diagnosed breast cancer i-iii stage * undergo first chemotherapy * have a smartphone * receiving treatment: ec/ ec+t/lc/lc+t e: (epirubicin)、c: (cyclophosphamide)、l: (lipo-dox)、t: (taxotere) exclusion criteria: * dsm-v mentally ill * ios system smartphone * over 65 years old

Keywords: breast cancer mobile application resilience self-efficacy
-oleoyl glycerol is a gpr119 agonist and signals glp-1 release in humans.

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to evaluate the impact of different ligands of gpr 119 (a g protein-coupled receptor in the intestine) on the secretion of the incretin hormones, glp-1 and gip.

we have found a new ligand for the gpr 119 receptor. this study evaluate the impact of this ligand on the incretion hormone responses, beta cell function and gall bladder function in healthy young men.

Eligibility criteria:
inclusion criteria: * healthy caucasians v- normal ogtt (75 g of glucose) according to who's criteria * normal hemoglobin * informed consent exclusion criteria: * liver disease (alat\> 2x normal level) * nephropathy (s-creatinin \>130 microm or albuminuria) * relatives with type 2 diabetes

Keywords: gpr 119 glp-1 secretion 2-oleoyl-glycerol dietary supplementation
risk factors of shoulder injuries in youth volleyball players

Conditions: Shoulder Injuries

Summary: shoulder injuries are usual in volleyball players. nowadays, few prospective studies assessed risk factors of shoulder injuries in this sport. so, the objective of this study is to assess the risk factors of injuries in youth volleyball players. for that purpose, the following factors will be taken into consideration : shoulder internal/external rotators strength, shoulder range of motion, scapular dyskinesis, functional tests (medicine ball throw and upper quarter y balance test), training load and psychosocial factors (poms questionnaire).

about 100 youth volleyball players (13-20 years), playing at least 8 hours volleyball in a week will be included in the study. at the beginning of the 2019-2020 season, they will have to take part at the following evaluations : 1. clinical evaluation : * scapular dyskinesis assessment (normal, subtle abnormality and obvious abnormality) * scapular upward rotation at 0°, 45°,90° and 120° with an inclinometer. * rounded shoulder posture * posterior shoulder stiffness * internal/external rotation range of motion (at 90° of abduction) 2. medicine ball throw : from a cocking position, players have to throw a 800g medicine ball as far as possible (3 trials). only the best result will be retained for analysis. volunteers have 2 minutes of rest between trials. 3. upper quarter y balance test : in a facial drop position, the purpose of this test is to bring the plastic board as far as possible in the 3 directions (supero-lateral, infero-lateral, medial). 3 trials are performed by each subject and only the best test is kept for analysis. a rest period of one minute is provided between tests to avoid fatigue. 4. strength assessment (isokinetic test) : internal and external rotators strength (concentric 60°/s, eccentric 60°/s and concentric 240°/s) are measured with an isokinetic device (cybex norm) at 90° of abduction. 5. psychosocial factors assessment : players will have to fill in poms questionnaire (65 questions), that give information about stress and well-being. after that, players will be followed during all the 2019-2020 season and will have to fill in a form each month about the potential injuries they had during the previous month.

Eligibility criteria:
inclusion criteria: * age between 13 and 20 * to play volleyball at least 8 hours in a week exclusion criteria: there are no exclusion criteria

Keywords: strength risk factors youth volleyball players
effects of aripiprazole (lai) on phychosocial/cognitive functioning, pt reported acceptabilityoftreatment in sch

Conditions: Schizophrenia

Summary: nautralsitic, open-label, single arm, uncontrolled study evaluating the effects of long acting injectable (lai) on phychosocial functioning congitive functioning and patient reported acceptability of treatment 'reported acceptability of treatment' regarding quality of life subjective well-being under neuroleptic medication in schizophrenia patients

primary objective * to evaluate the efficacy of aripiprazole long acting injectable form in turkish patients with schizophrenia on psychosocial functioning, quality of life and patient reported acceptability of treatment. secondary objective(s) * to evaluate the cognitive functioning of the patients * to evaluate positive and negative symptoms of the aripiprazole long acting injectable (lai), * to evaluate adherence of aripiprazole long acting injectable (lai) treatment, * to evaluate tolerability of aripiprazole long acting injectable (lai).

Eligibility criteria:
* inclusion criteria: * participants 18-45 of years age fulfilling dsm-iv-tr diagnostic criteria of schizophrenia, * disease history of ≤ 3 years (≤ 3 years after the emergence of first psychotic symptoms), * a history of symptom exacerbation or relapse when not receiving antipsychotics therefore requiring maintenance antipsychotic treatment, * informed written consent, * not on any antipsychotic treatment at least for 3 months or requiring a switch in treatment for any reason (lack of efficacy/ inadequate response to current antipsychotic(s), intolerance, nonadherence), and with the potential to benefit from extended treatment with an lai formulation, in the investigator's opinion. * lack of efficacy is defined as subjects with a baseline total panss score ≥70 or ≥2 items scoring ≥4 in the positive or negative symptom subscale * lack of tolerability is defined as the presence of clinically relevant side effects with the previous antipsychotic medication. * being literate in order to be able to answer the self report scales. * exclusion criteria: * dsm-iv-tr diagnosis other than schizophrenia or experiencing acute depressive symptoms in the past 30 days requiring adt depending on the clinical decision of the investigator. * antipsychotic resistant or refractory schizophrenia * a history of failure to clozapine treatment or response to clozapine treatment only. * significant risk of violent behavior or risk of self-harm * currently meets dsm-iv-tr criteria for alcohol and substance dependence * any clinically significant medical or neurological disorder * any medically significant abnormal laboratory test or ecg result at screening * pregnant, lactating.

Keywords: schizophrenia quality of life functionality long acting injectable aripiprazole naturalistic open-label single arm uncontrolled study
effects of n-acetylcysteine on diabetic foot oxygenation

Conditions: Foot Ulcer, Diabetic

Summary: the purpose of this study is to determine whether n-acetylcysteine is effective in the treatment or prevention of the foot ulcers in diabetic patients.


Eligibility criteria:
inclusion criteria: * age between 45 and 70 years. * type 1 or 2 diabetes mellitus with foot ulcer (grade 0 stage c according to texas university classification). * written informed consent. exclusion criteria: * n-acetylcysteine assumption in the 6 months previous to the study. * hypersensibility to acetylcysteine. * neoplasms, severe systemic, hepatic, pulmonary, cardiovascular or renal diseases. * psychiatric diseases or drug abuse problems.

Keywords: stage c grade 0 (texas university)
an initial study of the implementation of digital therapeutics for substance use disorders in primary care

Conditions: Drug Use Disorders; Illicit Drug Use; Alcohol-Related Disorders

Summary: the digits trial addresses a critical knowledge gap: how to best implement digital treatments for opioids and other substance use disorders in primary care. in this pilot study, the fda-authorized reset and reset-o digital therapeutics will be implemented in 2 primary care clinics as part of quality improvement. the pilot is comprised of a 3-month period in which a standard approach to implementing reset and reset-o is applied in the two primary care clinics "standard implementation", followed by a second 3-month period in which the study will test and refine the two experimental implementation strategy interventions, health coaching (patient-facing) and practice coaching (clinician-facing) in the same clinics. this study will also pilot economic data collection tools and collect qualitative data for a formative evaluation. the analytic goals are to inform the statistical design and data collection processes for the subsequent cluster-randomized digits trial.


Eligibility criteria:
inclusion criteria: * had a primary care visit in a participating clinic during the pilot * screened positive for substance use * adult aged 18 years or older at time of visit exclusion criteria: * none

Keywords: implementation science mobile applications drug use disorders quality improvement primary health care
impact of metal density on deformity correction for adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: a retrospective analysis to ascertain the correlation between metal density and deformity correction among individuals with adolescent idiopathic scoliosis.

posterior spinal fusion with pedicle screws has become the "gold standard" for the management of adolescent idiopathic scoliosis (ais). pedicle screws provide three column fixation through the strongest part of vertebra thereby enhancing surgeon's ability to do a 3-dimensional deformity correction. the higher pullout strength results in less long-term loss of correction, shorter fusions resulting in preservation of motion segments, lower pseudarthrosis rates and lower implant failures compared with these alternative posterior instrumentation systems. however, studies are contradictoryregarding the effect of metal density on coronaland sagittal curve corrections. multiple factors including curve flexibility, instrumentation and rod types, reduction strategies and curve types, affect outcomes. given this, intraoperative decisions regarding the number of anchorage points remain difficult, with considerable inter-surgeon variability. the rationale for using a high implant density constructs is to obtain more rigid fixation and to limit potential stress concentration at any one screw. furthermore, health-related quality of life instruments such as the srs 22, 24, or 30 seem to show little correlation with curve correction. the placement of every additional pedicle screw is associated with increased operative time, risk of neurological deterioration and increased implant cost. if implant density can be lowered without compromising clinical results, reducing the number of screws may improve the efficiency and cost effectiveness of scoliosis surgery. several authors have demonstrated successful results with low-density instrumentation for the treatment of scoliosis. the purpose of this retrospective review is to describe the demographics of our patient population and to ascertain correlation between metal density and correction achieved.

Eligibility criteria:
inclusion criteria: * patients with adolescent idiopathic scoliosis * age more than 10 years at time of surgery * posterior instrumentation consisting of all pedicle screw construct except for bilateral hooks at the uppermost instrumented vertebra * a major curve magnitude between 45 and 80 degrees. exclusion criteria: * scoliosis patients with a diagnosis other than adolescent idiopathic scoliosis * previous spine surgery * use of spinal osteotomies in addition to posterior spinal fusion with pedicle screws * alenke 5 curve * patients with less than 2 years' follow-up * use of hooks or wires below the uppermost instrumented level

Keywords: adolescent idiopathic scoliosis posterior instrumentation metal density correction pakistan
pyrotinib plus trastuzumab versus pertuzumab plus trastuzumab

Conditions: Breast Cancer

Summary: pyrotinib plus trastuzumab versus pertuzumab plus trastuzumab

this is a retrospective study aiming to explore the efficacy and safety of pyrotinib plus trastuzumab versus pertuzumab plus trastuzumab in patients with her2-positive metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * her2+ mbc patients scored +3 by immunohistochemical (ihc) analysis or scored +2 and the result of fluorescence in situ hybridization was positive. * patients received pyrotinib(320-400 mg, po, qd) plus trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) or pertuzumab(840mg q3w, and then 420 mg q3w) plus trastuzumab(8 mg/kg q3w, and then 6 mg/kg q3w) for at least one cycle, starting from jan 2018 to sep 2022. * patients had complete medical records. all data were retrospectively collected from medical records of individual institutions. exclusion criteria: * incomplete medical history

Keywords: pyrotinib trastuzumab pertuzumab
nimotuzumab with radiotherapy in the treatment of anal canal cancers

Conditions: Squamous Cell Carcinoma of Anal Canal

Summary: the objective of this study is to demonstrate the feasibility of using nimotuzumab and radiation in the treatment of squamous cell carcinomas of the anal canal in order to achieve a 65% local control rate with a better toxicity profile than the conventional treatment. patients with high toxicity risks (hiv+ and fragile patients) will be selected for this study.


Eligibility criteria:
inclusion criteria: for both step i and ii: * patients with histologically confirmed squamous cell carcinoma of the anal canal * aged 18 years or older * ecog: 0-1-2 * adequate contraception in women of child-bearing potential and for men * ability to understand and the willingness to sign a written informed consent document. * hiv-positive patients with t1-2 anal canal tumors, or * patients with anal canal tumors not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities) * patients who have already started radiotherapy for anal canal cancer for step ii: * hiv-positive patients with t1, t2 anal canal tumors * hiv-negative patients not eligible for conventional chemotherapy (for example, due to age and/or co-morbidities) * hiv-negative patients with t1-2 anal canal cancer exclusion criteria: for both step i and ii: * patients receiving any other investigational agents * previous treatment with anti-egfr drugs * history of allergic reactions attributed to compounds of similar chemical or biologic composition to nimotuzumab or other agents used in study. * previously treated with pelvic radiotherapy. * lesions not suitable for radiotherapy * patients with uncontrolled hypercalcemia * uncontrolled intercurrent illness * pregnant or breast-feeding women * any concurrent active malignancy * patients with t3-4 anal canal tumors or patients with nodes positive. step i: * hiv-negative patients with anal canal tumors that are judged suitable for current treatment consisting in radiotherapy and 5-fu and mmc chemotherapy
stress and resilience in anesthesia professionals

Conditions: Stress, Professional; Resilience; Anaesthesiology; High Fidelity Simulation

Summary: the purpose of this study was to analyze the correlation between the resilience of anesthesia professionals and the stress measured during a simulation session.

this trial will be carried out at the simulation center of the training institute for health professionals of the chu grenoble alpes. volunteer anesthesia professionals and students will perform a scenario simulating a pediatric laryngospasm during a surgical incision. each scenario will be performed by a medical and paramedical anesthesia pair and supervised by simulation trainers. stress and resilience measures will be taken at various times during the study. participants will be debriefed at the end of the simulation. the primary objective is to analyze the correlation between anesthesia professionals' resilience and measured stress.secondary objectives are to study the association between: sdnn-measured stress and vas-reported stress, age and sdnn-measured stress, cd risc 10 resilience and pss10-reported stress, cd risc resilience and vas-reported stress, the effect of experience on sdnn-measured stress, multiple correlation of the different secondary criteria. secondary criteria.

Eligibility criteria:
inclusion criteria: - volunteer in anesthesia exclusion criteria: * rhythm disorders * endocrine pathology * high blood pressure * pregnancy or breastfeeding in progress * taking anti-inflammatory or psychotropic drugs that interfere with the heart rate * interruption of professional practice in anesthesia \> 2 years