Kornimate/medical-research-clean huggingface dataset:
pet/ct-directed hyperfractionated radiation dose escalation in esophageal cancer

Conditions: Esophageal Cancer

Summary: the goal of this study is to find the maximum tolerable dose of radiation that can be delivered with concurrent chemotherapy (carboplatin \& paclitaxel) in patients with esophageal cancer.

concurrent chemoradiotherapy is the standard of care for esophageal cancer based on the results of phase iii randomised trials. the current standard radiation therapy dose has remained 50 gy at -2 gy/fraction for decades.however, locoregional control remain problematic, with 25% of patients having persistence and 20% relapse of locoregional disease following the combined modality approach. new regimen is urgently needed for improving localregional control and survival.investigators hypothesize that hyperfractionated radiation dose escalation to residual tumor volumes after standard chemoradiotherapy as defined by positron emission tomography (pet) /computed tomography (ct) would improve local control and overall survival while reducing the acute and late normal tissue toxicity.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed primary squamous cell carcinoma of the esophagus 2. age 1 8-75. 3. patients must be deemed unresectable disease or patient is not deemed operable due to medical reasons. 4. patients with distant metastasis and life expectancy \>/= 3 months are eligible. 5. zubrod performance status 0 to 2 6. no prior radiation to the thorax that would overlap with the current treatment field. 7. patients with nodal involvement are eligible 8. adequate bone marrow, renal and hepatic functions as assessed by the following: hemoglobin \>/= 10.0 g/dl, platelet count \>/= 1 00,000/mm\^3,absolute granulocyte count (agc) ≥2 × 10\^9 cells/l,bilirubin and aspartate transaminase ≤1.5 ×upper limit of normal (uln), creatinine \</=1 .5 times uln. 9. a signed informed consent must be obtained prior to therapy. 1 0. induction chemotherapy is allowed exclusion criteria: 1. the presence of a fistula. 2. prior radiotherapy that would overlap the radiation fields. 3. gastroesophageal junction cancer. 4. uncontrolled concurrent illness including, but not limited to: chronic 5.obstructive pulmonary disease(copd) exacerbation or other respiratory illness, serious uncontrolled infection, symptomatic congestive heart failure (chf),unstable angina pectoris, uncontrolled hypertension,or psychiatric illness/social situations that would limit compliance with the study requirements. 6.known hypersensitivity to paclitaxel. 7.any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study. acquired immune deficiency syndrome. 8.conditions precluding medical follow-up and protocol compliance
multicenter trial of meditation and health education for cardiometabolic disease in black women

Conditions: Atherosclerotic Cardiovascular Disease; Metabolic Syndrome

Summary: this randomized controlled trial compared the efficacy of stress reduction with meditation to a health education (he) group in 201 older african american women over a one-year study period. they were randomly allocated to either of two behavioral treatment groups-the transcendental meditation (tm) program or a health education (he) program. participants were recruited, tested, and instructed at two clinical sites: howard university hospital, washington, dc and morehouse (school of medicine) healthcare, atlanta, ga. main outcome measures were carotid intima-media thickness, insulin resistance, and behavioral factors.

this was a randomized controlled trial that compared the effects of stress reduction using the transcendental meditation technique (tm) to a health education (he) group in 201 african american women \>55 years with cvd or at high cvd risk over a one-year intervention and follow-up period. all participants were randomly allocated to either of two behavioral treatment groups-1) the transcendental meditation (tm) program or 2) a health education (he) program of healthy diet, exercise and substance use control. women participants were recruited, tested, and instructed at two sites:139 were recruited and randomized in washington, dc and 61 in atlanta, ga. outcome measures were carotid intima-media thickness (imt), insulin resistance, serum lipids, blood pressure and lifestyle (diet, exercise, substance use).

Eligibility criteria:
inclusion criteria: * african american women, * 55 years or older with at least one of the five cardiovascular conditions (below): either/or: * coronary heart disease or * positive coronary angiography or * previous mi or * coronary revascularization or * percutaneous transluminal coronary angioplasty (ptca). or a risk factor assessment score of at least two points based on the framingham study/atp iii report. risk factors included diabetes, high systolic or diastolic bp, high cholesterol, high ldl-low hdl or smoking. exclusion criteria: recent (last 3 months): * myocardial infarction * unstable angina * coronary artery by-pass grafting (cabg) * percutaneous transluminal coronary angioplasty (ptca) * stroke within the preceding three months * carotid artery endarterectomy * atrial fibrillation * second or third degree av block * heart failure * clinically significant valvular heart disease * major psychiatric disorders, * current alcohol/dependency disorder * other drug abuse dependency disorder * non-cardiac life-threatening illness * participating in a formal stress management program * plans to move out of the study area or travel extensively * unwillingness to accept randomization into any study group.

Keywords: meditation transcendental meditation health education prevention health disparities women's health
correlation between ptp1b expression and organ failure during sepsis

Conditions: Sepsis

Summary: despite major advances in the treatment and understanding of the pathophysiological mechanisms, mortality of severe sepsis remains high, ranging from 25 to 50%. with a prevalence \> 20% in intensive care units, it is now in a population increasingly aging with many co-morbidities, a real public health problem. thus, changes in treatment to physiological axes could change the prognosis of these patients. protein tyrosine phosphatase 1b (ptp1b) is involved in the negative regulation of many cellular pathways such as the response to insulin, leptin and certain growth factors and endothelial nitric oxide production. ptp1b appears to be particularly involved in the control of endothelial function and insulin secretion. under these conditions, encouraging results have been obtained in a model of insulin resistance (obesity, diabetes) and as part of pro-angiogenic therapy by inhibition of ptp1b on models of heart failure. recent advances have broadened the pathophysiological implications of ptp1b conferring a potential role in the regulation of inflammatory processes. in an experimental model of septic shock (inserm 1096), the investigators demonstrated a significant improvement in survival and cardiovascular function in genetically deficient mice ptp1b (ptp1b - / -). finally, ptp1b is involved in the downregulation of the signaling pathway of insulin via a feedback phenomenon. septic shock induces many changes in carbohydrate metabolism. these changes result in hyperglycemia associated with insulin resistance, an independent risk factor of morbidity and mortality. taken together, these data suggest that the expression of ptp1b could be useful in septic patients by modulating insulin resistance and thus the prognosis of these patients. this justifies the investigator clinical research project on the relationship between the expression of ptp1b levels, glycemic status and prognosis evaluated by the sofa score in patients with septic shock with multiple organ failure.


Eligibility criteria:
inclusion criteria: * patients in icu for septic shock * person belonging to a social security system * informed patient who signed consent * contraceptive method in women of reproductive age exclusion criteria: * pregnancy * patient not able to take a decision because of an administrative or legal decision * patient participating to an other interventional study * bmi \> 30 kg/m2 * diabetes with specific treatment

Keywords: sepsis septic shock
patients' perspective on radiofrequency catheter ablation of avrt and avnrt

Conditions: Tachycardia, Atrioventricular Nodal Reentry; Re-entrant Atrioventricular Tachycardia

Summary: atrioventricular nodal reciprocating tachycardia (avnrt) and atrioventricular reciprocating tachycardia (avrt) are two similar supraventricular re-entry tachycardias (svt) emerging in relatively young age in patients without apparent structural heart disease or significant comorbidities. the treatment of choice in those patients is radiofrequency ablation (rfa). the ppra study is a prospective observational study developed to thoroughly analyze quality of life, utility and willingness-to-pay of polish patients undergoing rf ablation of avnrt or avrt. based on collected data the investigators will prepare a profile of patient who will benefit most from radiofrequency ablation and who should be scheduled in first place for the ablation in case of problems with accessibility to this service. what is more an analysis of medical and indirect costs of care will be performed.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. age above 18 3. scheduled rfa due to avnrt or avrt 4. sufficient knowledge of the polish language to independently complete the questionnaires exclusion criteria: 1. no written informed consent 2. health states significantly impairing qol (eg. stroke, advanced heart failure)

Keywords: avnrt avrt wpw
comparison of subject-driven titration of biphasic insulin aspart (biasp) 30 twice daily versus investigator-driven titration of biasp 30 twice daily both in combination with oral antidiabetic drugs in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of this trial is to compare biasp 30 twice daily individually adjusted by the subject versus biasp 30 twice daily individually adjusted by the investigator both combined with oral antidiabetic drugs (oads) in subjects with type 2 diabetes inadequately controlled with premixed human insulin. subjects to continue their oad background treatment: metformin plus/minus alpha-glucosidase inhibitor.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * type 2 diabetes mellitus (diagnosed clinically) for at least 12 months * currently treated with premixed/self-mixed human insulin (proportion of short-acting insulin is equal to or lower than 30%) bid (twice daily) combined with metformin with or without alpha-glucosidase inhibitor for at least 3 months prior to screening visit (visit 1) with the minimum dose stated: metformin: at least 1500 mg/day or maximum tolerated dose at least 1000 mg/day (with unchanged dosing within 3 months prior to visit 1) or alpha-glucosidase inhibitors: acarbose or miglitol at least 150 mg/day, or voglibose at least 0.6 mg/day * total daily insulin dose below 1.4 iu/kg * hba1c above or equal to 7.0% and below or equal to 9.5% (central laboratory) * body mass index (bmi) below or equal to 35.0 kg/m\^2 exclusion criteria: * treatment with any insulin secretagogue, thiazolidinedione (tzd), dipeptidyl peptidase-4 (dpp-4) inhibitors and glucagon-like peptide-1 (glp-1) receptor agonists within the last 3 months prior to visit 1 * previous use of insulin intensification treatment (premixed insulin thrice daily, basal bolus regimen, and continuous subcutaneous insulin infusion (csii)) for more than 14 days * previous use of any insulin other than premixed/self-mixed human insulin (proportion of short acting insulin equal to or lower than 30%) bid within 3 month prior to visit 1 * recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic episode, during the last 12 months) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis during the previous 6 months * known proliferative retinopathy or maculopathy requiring treatment
empagliflozin in renal transplant recipients

Conditions: Diabetes Mellitus; Renal Insufficiency; Safety Issues

Summary: this is a single-center, prospective, controlled, double-blind, randomized study. a total of 50 renal transplant recipients diagnosed with post-transplantation diabetes mellitus (ptdm) will be included more than 1 year after transplantation and randomized 1:1 to empagliflozin (jardiance®) 10 mg or placebo once daily for 24 weeks. patients with estimated glomerular filtration rate below 30 ml/min will be excluded. oral glucose tolerance test, 72h continuous glucose monitoring (ipro™2), measurement of arterial stiffness, body composition (including visceral fat), 24h blood pressure and 24h urinary glucose excretion will be performed at baseline and after 24 weeks in addition to standard safety measurements. two safety visits will be performed at week 8 and 16. all concomitant medication, diet and exercise will be kept stable during the study period. the objective of the present study is to answer whether empagliflozin safely and effectively improves glucose metabolism together with weight loss in renal transplant recipients with ptdm.


Eligibility criteria:
inclusion criteria: * renal transplant recipient transplanted more than 1 year ago * stable renal function (\<20% deviation in serum creatinine within last 2 months) * stable immunosuppressive therapy ≥3 months before inclusion * diagnosed with ptdm: (fasting plasma glucose ≥7.0 mmol/l and/or 2-hour plasma glucose ≥11.1 mmol/l following an oral glucose tolerance test) -signed informed consent and expected cooperation of the patients exclusion criteria: * estimated gfr \<30 ml/min/1.73 m2 * pregnant or nursing mothers * hypersensitivity to the active substance (imp) or to any of the excipients * any reason why, in the opinion of the investigator, the patient should not participate
acute effects of endurance exercise on breastmilk composition

Conditions: Breastmilk

Summary: the investigators will determine the acute effect of exercise on breastmilk composition. participants will come in to the lab on three different days, out of which they will exercise on two of these days and rest in the lab on the third day. the conditions will be randomly allocated to each participant. breastmilk samples will be obtained in the morning of each test day, as well as immediately after, one hour after and four hours after the exercise/rest condition. dietary intake will be standardized on the test days. at the time of study commencement, the trial (including planned analyses) is not fully funded. additional milk will be stored for future analyses (not yet specified) when funding is secured.


Eligibility criteria:
inclusion criteria: * 6 to 12 weeks postpartum * exclusive breastfeeding * term birth exclusion criteria: * known cardiovascular disease * type 1 or 2 diabetes mellitus * limited ability to exercise

Keywords: exercise
a study to assess safety and effectiveness of adalimumab for treating children and adolescents with crohn's disease in real life conditions

Conditions: Crohn's Disease

Summary: the primary objective of this study is to evaluate long-term effectiveness of adalimumab in pediatric participants starting a treatment for crohn's disease in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach. main secondary objectives are to describe growth and pubertal development and to describe long-term safety. the participants will be followed-up up to 10 years.


Eligibility criteria:
inclusion criteria: * with confirmed diagnosis of crohn's disease * adalimumab-naïve patient (a patient having received an anti-tnf other than adalimumab may enter the study) * starting a treatment with adalimumab * guardian capable of and willing to grant authorization for use/disclosure of data collected and patient able to comply with the requirements of the study protocol. exclusion criteria: * participants with a history of treatment with adalimumab * participants enrolled in a concomitant interventional clinical trial.

Keywords: crohn's disease adalimumab humira®
marfan syndrome and quality of life of pediatric patients

Conditions: Rare Diseases; Pediatric Disorder

Summary: the goal of this observational study is to learn about the impact of marfan syndrome (mfs) in paediatric affected subjects. the main questions it aims to answer are: * the assessment of quality of life in mfs italian patients; * the impact of phenotypic manifestations on self-image and self-management skills; * stratify patients according to the need of psychological support. participants will take part in the study by completing four self-report questionnaires.

in literature, adolescents with mfs experience difficulty in connecting with peers, and are convinced that they would have been more physically attractive without the disease. additionally, due to physical activity restrictions and orthopedic limitations, these patients reported having difficulty adjusting and participating in educational events. data from present study will be able to support clinicians in identifying patients who need psychological support (through parental counseling interviews) aimed at increasing compliance with treatments and adaptation to the disease.

Eligibility criteria:
inclusion criteria: * signed informed consent; * mfs diagnosis according to revised ghent criteria (2010); exclusion criteria: * known cognitive deficits

Keywords: quality of life self-identification self-care
clinical evaluation of telmisartan-based antihypertensive regimen

Conditions: Hypertension; Metabolic Syndrome X

Summary: to determine the efficacy and safety of telmisartan-based treatment among patients with metabolic syndrome in actual setting in philippines.


Eligibility criteria:
inclusion criteria: * age \> 45 years * increased waist circumference (\>88.9cm \[\>35in\] men, \>78.7cm \[\>31in\] for women) * elevated triglycerides (\>150mg/dl) * low hdl cholesterol (\<40mg/dl in men, \<50mg/dl in women) * hypertension (\>130/\>85mmhg) * impaired fasting glucose (\>110mg/dl) (8) * hypertensive patient assessed to benefit from telmisartan based treatment exclusion criteria: * hypersensitivity to telmisartan, hydrochlorothiazide (hctz) and its excipients * \<3 months myocardial infarction (mi), stroke or severe heart failure
music and essential oil in agitation

Conditions: Agitation

Summary: the study aims to assess the effect of using music and essential oil on agitation in mechanically ventilated patients. listening to classical relaxation music, and inhalation to bergamot oil will be used in this study.

agitation in critically ill patients is a phenomenon that can compromise patient safety and assistance during intensive care unit (icu) hospitalizations. this trial will be conducted in five general intensive care unit. one hundred and twenty patients will be enrolled in this study divided into three equal groups (40 patients in each group). group a is the control group. group b is music group. group c is essential oil group. agitated mechanically ventilated patients will be randomly assigned to one of the three groups. each group will be subjected to its specific intervention and they will be monitored for seven days. agitation score and frequency outcome will be assessed at the end of the study.

Eligibility criteria:
inclusion criteria: * agitation with rass score +2 or more * mechanical ventilation * patients with gcs 13-15 exclusion criteria: * psychiatric illness * cognitive disorders * neurological disorder * hearing deficit * smelling deficit * respiratory asthma * allergic rhinitis

Keywords: mechanical ventilation music therapy essential oil bergamot oil
naproxen versus tramadol for post cesarean pain control

Conditions: Pain; Cesarean Section

Summary: oral naproxen might be more efficacious for post-cesarean pain-control and have better side-effects profile than oral tramadol.


Eligibility criteria:
inclusion criteria: * all patients after cesarean section exclusion criteria: * emergent cs * hypersensitivity to drug * drug abuse

Keywords: pain control after cesarean section
an open label, expanded access protocol with sage-547 for super-refractory status epilepticus

Conditions: Super-Refractory Status Epilepticus

Summary: this is an open-label, expanded access protocol, designed to offer treatment with sage-547 to subjects in srse, and to evaluate the efficacy and safety of sage-547 administered as a continuous intravenous infusion to these subjects


Eligibility criteria:
inclusion criteria: * subjects six (6) months of age and older * subjects who have: * failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial aed treatment), according to the institution's standard of care, and; * failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control aeds), according to the institution's standard of care, and; * not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agents and in an eeg burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents but not in an eeg burst or seizure suppression pattern. exclusion criteria: * subjects with srse due to anoxic/hypoxic encephalopathy with highly malignant/ malignant eeg features * children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder * subjects who have any of the following: 1. a gfr low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned; 2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use; 3. fulminant hepatic failure; 4. no reasonable expectation of recovery or life-expectancy of less than 30 days. * subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol