Kornimate/medical-research-clean huggingface dataset:
impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis

Conditions: Biliary Pancreatitis

Summary: impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study.

impact on outcome of early endoscopic extraction of bile duct stones in biliary pancreatitis: a prospective multicenter randomized controlled study. main objective: to test the interest of early bile duct decompression by endoscopic sphincterotomy after early non invasive diagnosis by endosonography or mr cholangiography. prospective multicenter randomized controlled study with direct patient benefit

Eligibility criteria:
inclusion criteria: * previous medical examination * age over 18 * acute biliary pancreatitis * timespan between onset of symptoms and randomization \<72h * no involvement in another clinical study * informed consent obtained exclusion criteria: * non biliary pancreatitis * age \< 18 * timespan between onset of symptoms and randomization \>72h * no follow-up possible beyond 3 months after inclusion * ongoing pregnancy * no informed consent * no health insurance affiliation * involvement in another clinical study * incapacity to understand subject information * counter indication of mri examination if echo-endoscopy is not available

Keywords: biliary pancreatitis bile duct stones eus endoscopic ultrasonography endoscopic sphincterotomy ercp
association between the support of nicu team and subjective health of parents

Conditions: Conditions Influencing Health Status

Summary: preterm birth is a traumatic event for parents. they cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. the nicu team is the main support source for these parents. support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. the hypothesis of this study is that better support to parents lead to better subjective health feeling by them. the study will be held among mothers to infants in nicu who are at least 7 days old. the study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. sample size is about 150 mothers.

preterm birth is a traumatic event for parents. they cope with threatening and unfamiliar environment of hospital, losing the parental role, and frustration. the nicu team is the main support source for these parents. support and providing information are most important for parents, as they can have some control, involvement and self confidence during the hospitalization, and also feel healthier. the hypothesis of this study is that better support to parents lead to better subjective health feeling by them. the study will be held among mothers to infants in nicu who are at least 7 days old. the study will use a questionaire to assess the subjective health feeling and the estimation of the support from the team. sample size is about 150 mothers.

Eligibility criteria:
inclusion criteria: * mothers to preterm infants in nicu exclusion criteria: * mothers to infants in nicu who are not preterm * mothers to infants in nicu who died during hospitalization * mothers to infants in nicu who were transferred to another hospital during hospitalization

Keywords: subjective health feeling nicu team support
study to investigate whether afq056 reduces cocaine use in patients diagnosed with cocaine use disorder (cud)

Conditions: Cocaine-related Disorder

Summary: this study assessed whether afq056 had a beneficial effect by reducing cocaine use in cocaine use disorder (cud) patients as assessed by timeline follow-back cocaine self-report.

this was a randomized, subject- and investigator-blinded, parallel-group, placebo-controlled study in subjects with cud. the study consisted of a 17-day screening period followed by a 12-day baseline, a 98-day outpatient treatment period (14-day up-titration dose regimen followed by 84-day maintenance dose), and an end of study evaluation visit approximately 14 days after the last study drug administration. the total duration for each subject in the study was approximately 20 weeks including screening and baseline.

Eligibility criteria:
inclusion criteria: * understand the study procedures and provide written informed consent before any assessment is performed. * subjects diagnosed with cocaine use disorder according to dsm 5 (diagnostic and statistical manual of mental disorders, 5th ed.). * must use cocaine through snorting (intranasally) as primary route of administration. * recent cocaine use confirmed by positive urine screen for 1 or more benzoylecgonine (be). * must be seeking treatment for cocaine dependence and have a desire to reduce or cease cocaine use. exclusion criteria: * has current diagnosis of substance use disorder (according to the dsm 5) on alcohol, cannabis or other stimulants, except cocaine. * meets current or lifetime dsm 5 criteria for schizophrenia or any psychotic disorder, or organic mental disorder. * have current treatment for substance use disorder (e.g.: disulfiram, acamprosate, methyl phenidate, modafinil, topiramate, immediate release dexamfetamine,or baclofen). * pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test * have a history of any illness, condition, and use of medications that in the opinion of the investigator or designee might confound the results of the study or pose additional risk in administering the investigational agents to the subject or preclude successful completion of the study * current or/and previous treatment with concomitant medications that are strong or moderate inducers/inhibitors of cyp3a4 (e.g., clarithromycin, ketoconazole, ritonavir, etc.) * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result. * chronic infection with hepatitis b (hbv) or hepatitis c (hcv). * score "yes" on item 4 or item 5 of the suicidal ideation section of the cssrs, if this ideation occurred in the past 6 months, or "yes" on any item of the suicidal behavior section, except for the "non-suicidal self-injurious behavior" (item also included in the suicidal behavior section), if this behavior occurred in the past 2 years. * controlled hypertension

Keywords: cocaine use disorder; cocaine dependence,afq056,adult, cocaine use,cud, drug abuse, drug addiction,
flex-trial: prospective sonographic assessment of healing process following suture of profound flexor tendon due to traumatic rupture of fdp-tendon in zone ii.

Conditions: Tendon Injury

Summary: to prospectively assess the healing process following suture of profound fexor tendon due to traumatic rupture of fdp-tendon in zone ii by ultrasound.


Eligibility criteria:
inclusion criteria: * all patients with traumatic rupture of fdp-tendon in zone ii. exclusion criteria: * \< 18years; * fracture; * crush injury; (partial) amputation; * ra; * cppd; * cp;

Keywords: traumatic rupture of tendon
multi-channel aeeg in cardiac arrest patients with targeted temperature management

Conditions: Heart Arrest; Targeted Temperature Management

Summary: this study aims to examine the prognostic value of 18 channel amplitude-integrated eeg (aeeg) in comatose cardiac arrest patients the study design is a prospective observational study. cardiac arrest patients undergoing targeted temperature management (ttm) will participate in the study. relation of aeeg in each channel with the neurologic outcome at 6 month after return of spontaneous circulation (rosc) will be evaluated.

normal trace was defined as continuous cortical activity on the raw eeg scan; in addition, the upper margin of the aeeg scan, referred to as the aeeg maximum, was \>10 μ v, and the lower margin of the aeeg scan, referred to as the aeeg minimum, was \>5 μ v. the time from rosc to normal trace (ttnt, hours) is predictor of neurological outcome in these patients. we will evaluate the prognostic values of ttnts in all aeeg channels.

Eligibility criteria:
inclusion criteria: comatose cardiac arrest ttm treatment multi channel aeeg monitoring exclusion criteria: cerebral origin cardiac arrest known epilepsy
thai traditional massage increases biochemical marker of bone formation in postmenopausal women

Conditions: Osteoporosis

Summary: to investigate the skeletal effect of thai traditional massage by examining the changes in biochemical markers of bone turnover.


Eligibility criteria:
inclusion criteria: * postmenopausal women exclusion criteria: * history of hyperthyroidism, thyrotoxicosis, diabetes, rheumatoid arthritis and cancer * glucocorticoid or medication for osteoporosis * swelling joints

Keywords: thai traditional massage bone formation bone resorption
study comparing a fixed-dose capsule of esomeprazole 40mg and lda 325mg with free combination

Conditions: Ulcers; Upper GI Symptoms

Summary: the purpose of this study is to test if fixed dose esomeprazole and asa capsule is pharmaceutically equal to a free combination of esomeprazole capsule and asa tablet


Eligibility criteria:
inclusion criteria: * body mass index of 19-29kg/m2, inclusive * weight of 50-95kg, inclusive * clinically normal physical findings and laboratory values including hepatitis b, hepatitis c, and hiv, as judged by the investigator exclusion criteria: * significant clinical illness within the 2 weeks preceding the first dose of investigational products, as judged by the investigator * history of mental, cardiac, renal, hepatitis, neurological, or significant gastrointestinal disease, as judged by the investigator * condition which could modify the absorption of the investigational products, as judged by the investigator

Keywords: esomeprazole upper gi symptoms low dose aspirin treatment
the effect of storigami method on pain, fear and anxiety levels associated with peripheral intravenous catheterisation in children

Conditions: Pain

Summary: the aim of this study was to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic.

he stated that children and their families who frequently visit hospitals for follow-up, treatment or various anomalies have negative hospital experiences due to fear, anxiety and painful procedures, and that these negative experiences may cause phobias and avoidance of medical procedures in children in the future. therefore, this study was planned to determine the effect of storigami method on reducing pain, fear and anxiety of children in peripheral intravenous catheter applications in children aged 6-9 years who were hospitalized in the pediatric health and diseases clinic. storigami is a method that involves the use of origami and stories at the same time and can be used to reduce pain in hospitals. the method, which is planned to be used to minimize negative hospital experiences, is thought to be a promising, cost-effective and safe non-pharmacological technique that can be used safely to reduce fear, anxiety and pain of hospitalized patients.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * the child is between 6-9 years old * first time peripheral intravenous catheter insertion since admission to the clinic * the child has no vision, hearing and speech problems * the child has no mental retardation * know/speak turkish * no complaints such as pain, nausea and vomiting that may affect fear and anxiety * no sedative or analgesic was given to the child immediately before the peripheral intravenous catheterization procedure exclusion criteria: * the child has a chronic, congenital, metabolic or neurodegenerative disease * failed attempt at peripheral intravenous catheterization, * failure to complete or incomplete completion of questionnaires, * a different invasive intervention was performed immediately before pic application, * the child does not comply during the procedure, * the child wants to leave the study

Keywords: nurse child distraction methods
to study the effect of vytorin on intracellular lipid and inflammation in obese subjects

Conditions: Inflammation

Summary: this study focuses on the use of vytorin to study inflammatory markers in subjects with normal cholesterol.

following the first demonstration by our group that macronutrient (glucose, cream and a high fat high carbohydrate meal) intake results in increased ros generation and oxidative stress at the cellular and molecular level, the investigators have now shown in our preliminary data that cream intake induces comprehensive inflammation as reflected in increased intranuclear nfkb binding, decreased ikbα expression, increased expression of il-1β, il-12, tnfα and other pro-inflammatory mediators. while carrying out these experiments, the investigators asked whether cream intake was associated with an uptake of lipid by peripheral blood mononuclear cells (mnc). indeed, there was a significant increase in intracellular lipid which was visualized as intracellular lipid droplets. the increase in intracellular lipid droplets was associated with an increase in intracellular superoxide generation; the expression of cd68, a marker for macrophages; and pecam, the adhesion molecule which mediates trans- endothelial transfer of leucocytes. the investigators also found that the lipid fractions to increase were cholesterol ester, triglyceride and fatty acids. in view of the tantalizing observation that the lipid droplet laden mnc appeared to be monocytes, looked like foam cells and the fact that cd68 expression had increased, there is a possibility that foam cells may be formed in peripheral circulation by monocytes after a lipid rich meal. this simple model of foam cell formation also lends itself for the study of the effect of various lipid lowering drugs. our investigation will be the first to study this novel paradigm. the investigators plan to study the effect of a cholesterol lowering agent, vytorin (simvastatin and ezetimibe), on intracellular lipid in mnc, expression of cd68 and pecam, ros generation and inflammation in obese subjects. this investigation may provide an additional mechanism of action by which these drugs may reduce atherosclerosis.

Eligibility criteria:
inclusion criteria: 1. age 18-65years. 2. obese bmi \>30kg/m2 3. ldl cholesterol \>100 mg/dl 4. written and informed consent signed and dated 5. not on any vitamin/antioxidants exclusion criteria: 1. on any antilipid agents. 2. triglyceride \>500mg/dl 3. myocardial infarction, angioplasty/stent placement or coronary artery bypass surgery in the past 6 months 4. patient on chronic use of non-steroidal anti-inflammatory drugs or steroids 5. hepatic disease 6. renal impairment 7. history of drug or alcohol abuse 8. participation in any other concurrent clinical trial 9. use of an investigational agent or therapeutic regimen within 30 days of study. 10. smoker 11. pregnancy 12. premenopausal women who are not on birth control pills and have not had a hysterectomy or tubal ligation 13. anemia with hemoglobin \<12 g/dl
t-ir- study to understand the effects of testosterone and estrogen on the body's response to the hormone insulin

Conditions: Insulin Resistance; Type 2 Diabetes Mellitus; Obesity; Androgen Deficiency; Metabolic Disease

Summary: the purpose of this research study is to understand the effects of testosterone and estrogen on the body's response to the hormone insulin.

the investigators will examine the effects of testosterone on insulin sensitivity and body composition in men. this study may lend greater insight into the increased risk of diabetes evident in men with low circulating levels of testosterone. three drugs will be used in this study: acyline, given by injection; testosterone (t) gel that is applied to the skin; and letrozole, which is an oral drug that blocks the conversion of androgens (male hormones) to estrogens (female hormones). acyline inhibits the production of luteinizing hormone (lh) and follicle stimulating hormone (fsh). when acyline stops the production of these hormones, it blocks the signal from the brain that stimulates the testicles to make testosterone. adding testosterone to acyline will restore physiologic levels of testosterone in some study participants. one group of men will receive t gel with letrozole, an aromatase inhibitor; these men will have normal levels of testosterone but low levels of estrogen in the blood. this design will enable determination of the respective metabolic effects of testosterone and estrogen.

Eligibility criteria:
inclusion criteria: * prostate-specific antigen (psa) ≤ 3 ng/ml * age 25-55 years * ability to understand the study, study procedures and provide informed consent * serum total t \> 300 ng/dl * normal reproductive history and exam * international prostate symptom score (ipss) \< 11 exclusion criteria: * a history of prostate cancer including suspicious digital rectal exam (dre) or history of highgrade prostatic intraepithelial neoplasia (pin) on prostate biopsy * invasive therapy for benign prostatic hyperplasia (bph) in the past * history of acute urinary retention in the previous 3 months * current or recent past use of androgenic or anti-androgenic drugs, steroids or drugs which interfere with steroid metabolism (within the last 3 months) * current use of statins or glucocorticoids * severe systemic illness (renal, liver, cardiac, lung disease, cancer, diabetes mellitus) or skin disease * a history of or current breast cancer * known, untreated obstructive sleep apnea * hematocrit \> 50 or \< 34 * hypersensitivity to any of the drugs used in the study * history of a bleeding disorder or anticoagulation * participation in any other drug study within past 90 days * history of drug or alcohol abuse within the last 12 months * weight \> 280 lbs. or bmi ≥ 33 * desire for fertility in the next 6 months or current pregnant partner * sperm concentration \<14 million/ml * significant, uncontrolled hypertension (bp \>160/100 mmhg); subjects with well-controlled bp on medical therapy will be eligible to participate

Keywords: insulin androgens insulin resistance testosterone estradiol obesity
effective connectivity in patients receiving spinal cord stimulation: an fmri and eeg dynamic causal modeling study

Conditions: Failed Back Surgery Syndrome

Summary: in this study, a retrospective analysis will be performed on collected data of 14 patients with failed back surgery syndrome, treated with spinal cord stimulation. in separate studies, fmri and eeg recordings were made in resting state conditions on two time points. the fmri assessments and eeg recordings were performed before the scs implantation (baseline) and repeated around 3 months after the definitive scs implantation. during both assessments, patients were asked to fill in a vas diary for their leg and back pain (scores from 0 to 10). the aim of the current retrospective study is to correlate the clinical data obtained from the vas scores, with estimates of effective connectivity (obtained from fmri and eeg). effective connectivity will be calculated by using dynamic causal modeling (dcm) on the baseline data and the data obtained 3 months after scs. the aim is to evaluate whether dcm data of eeg is equally/worse/better correlating with the clinical data as dcm data of fmri.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old. 2. diagnosis of fbss with predominant leg pain (vas) \> 5) and non-dominant back pain. 3. cognitive and language functioning enabling coherent communication between the examiner and the subject; 4. failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy 5. stable neurologic function in the past 30 days 6. subject is included in the previous studies and both eeg and fmri data are available. exclusion criteria: 1. female subject of childbearing potential is pregnant/nursing, or plans to become pregnant during the course of the trial 2. subjects currently has an active infection

Keywords: eeg fmri correlation clinical data effective connectivity
ruxolitinib plus lvp in patients with r/r etp-all

Conditions: Acute T Cell Leukemia

Summary: to determine the maximum tolerated dose (mtd), if present, and dose schedule of ruxolitinib in combination with l-asp, vincristine, and prednisone (lvp) in patients with relapsed-and-refractory (r/r) early t precursor acute lymphocytic leukemia (etp-all). once determined, the purpose of this study will be to determine the efficacy of ruxolitinib in combination with lvp in patients with r/r etp-all.


Eligibility criteria:
inclusion criteria: 1. subjects with early t-precursor all, with any of the following: * refractory to primary induction therapy or refractory to salvage therapy, * in untreated first relapse with first remission duration \<12 months * in untreated second or greater relapse * relapse at any time after allogeneic hsct 2. subject has received intensive combination chemotherapy for the treatment of all for initial treatment or subsequent salvage therapy. 3. greater than 5% blasts in the bone marrow 4. eastern cooperative oncology group (ecog) performance status ≤ 2 exclusion criteria: 1. malignancy other than all within 5 years before recruitment, except for adequately treated selected cancers without evidence of disease 2. current relevant central nervous system (cns) pathology or known or suspected cns involvement 3. isolated extramedullary disease 4. current autoimmune disease or history of autoimmune disease with potential cns involvement 5. autologous hsct within 6 weeks or allogeneic hsct within 12 weeks before blinatumomab treatment, or eligibility for allogeneic hsct at the time of enrollment 6. active acute grade 2 to 4 graft versus host disease (gvhd) according to glucksberg et al (1974) criteria that required systemic treatment to prevent or treat gvhd 2 weeks before blinatumomab treatment 7. known exclusion criteria to investigator choice of soc chemotherapy (per package insert) 8. cancer chemotherapy or radiotherapy with 2 weeks, or immunotherapy (included cd19 therapy) within 4 weeks of protocol-specified therapy 9. abnormal laboratory values (alanine or aspartate transaminase \[alt or ast\] or alkaline phosphatase \[alp\] ≥ 5 × upper limit of normal \[uln\]; total bilirubin or creatinine ≥ 1.5 × uln), or calculated creatinine clearance \< 60 ml/min.