Kornimate/medical-research-clean huggingface dataset:
trial of endoscopic ultrasound (eus) - guided celiac plexus neurolysis

Conditions: Inoperable, Painful Pancreatic Cancer

Summary: pancreatic cancer presents with pain in the majority of cases. destruction of the celiac ganglia by ultrasound guided injection of sclerosing agents such as alcohol is sometimes used for pain that no longer responds to treatment with narcotics. the investigators compare standard narcotic treatment to celiac plexus alcohol injection (celiac plexus neurolysis) and do so in patients with early, mild pain to see if celiac plexus neurolysis is more effective than narcotics and prevents escalating narcotic use.

this is a randomized, double blind, sham-controlled trial designed to evaluate the efficacy of early eus-guided celiac plexus neurolysis (eus-cpn). "early" refers to the fact that, in contrast to previous cpn trials, we targeted patients with inoperable, painful pancreatic cancer in whom pain was mild and who were taking little or no narcotics. our a priori hypotheses were that, compared to conventional management with narcotics alone, early neurolysis: 1) will better control pain related to inoperable pancreatic cancer, 2) will prevent the escalating use of narcotics associated with disease progression, 3) will improve quality of life, and 4) will improve survival. the aim our study is to test these 4 hypotheses.

Eligibility criteria:
inclusion criteria: * previous imaging and/or the eus examination demonstrated inoperable pancreatic cancer defined as involvement of the superior mesenteric vein, portal vein or confluence, superior mesenteric artery, celiac axis, hepatic artery, or non-regional lymphadenopathy * a new diagnosis of pancreatic adenocarcinoma was confirmed by an on-site cytopathologist following eus fine needle aspiration (eus-fna) exclusion criteria: * allergy to bupivicaine * possible future surgical management of the tumor * expected survival less than 3months (suspected or proven carcinomatosis or liver metastases) * inability or unwillingness to provide informed consent prior to the eus

Keywords: pancreatic cancer therapy neurolysis
stress management and resiliency training for depression vs treatment as usual in the treatment of major depression

Conditions: Major Depression

Summary: researchers are trying to find out if a stress management and resiliency training (smart-d) therapy will help with major depression treatment.


Eligibility criteria:
inclusion criteria: * participants will be enrolled for this study from patients attending the mayo clinic depression center, mayo clinic family medicine clinics, behavioral health and primary care clinic at mayo clinic health system, austin, mn, with a diagnosis of major depression, in partial or near remission with phq-9 scores ≤14 * participants will be required to be between 25 and 80 years old * able to speak english * able to provide written informed consent to participate in the study * participants must have dsm-v diagnostic confirmation of major depressive disorder (mdd) (american psychiatric association 2013). * participants will continue taking any prescribed medications from their clinical treatment team. * participants with co-morbid secondary diagnoses of persistent depressive disorder and generalized anxiety disorders will be included in the study. * participants must consent to audio recording of random group sessions which will be disclosed at the final study session. exclusion criteria: * participants with bipolar disorder, active psychosis, active suicidal ideations, and active substance abuse meeting criteria for substance use disorders except nicotine, obsessive compulsive disorder, active panic disorder with agoraphobia or other phobic disorder, active posttraumatic stress disorder, active severe personality disorders will be excluded. * pregnant women - because of time duration of the study.
cancer and mindfulness-based cancer recovery after chemotherapy

Conditions: Breast Cancer; Colorectal Cancer; Ovarian Cancer; Uterine Cancer

Summary: upon the completion of aggressive chemotherapy and radiation for curative intent cancers, many cancer survivors suffer from a myriad of symptoms ranging from physical symptoms such as hot flashes, insomnia, and fatigue to psychosocial symptoms including depression and anxiety. mindfulness based cancer recovery (mbcr) is a type of mind-body intervention. mind-body interventions are defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being.

mbcr is a step wise standardized behavioral intervention of mbsr. the program is usually conducted in eight weekly class sessions that are 2-2.5 hours in length. during class sessions, participants are presented with mindfulness meditation techniques and share their experiences related to these meditation practices. there is a home practice component with an expectation of regular home meditation practice of 45 minutes per day. in addition to home meditation practice there are often reading assignments and reflective exercises that relate to mindfulness. a full day retreat generally occurs in the second half of the course, providing an opportunity for class participants to gain extended experience with mindfulness techniques.

Eligibility criteria:
inclusion criteria: * stage i-iii breast cancer, gynecologic cancer or colorectal cancer * cancer survivor at least 18 years of age at the time of study enrollment * completed chemotherapy within the past six months at the time of consent (adjuvant hormone therapy is allowed) exclusion criteria: * psychologic disease in which informed consent cannot be obtained from the subject * need for ongoing chemotherapy and/or radiation therapy
cytokine filter usage during open thoracoabdominal aortic aneurysm repair- a single-center randomized prospective trial

Conditions: Postoperative Complications; Inflammatory Response

Summary: prospecrtive study including 20-30 randomized patients treated by open repair because of an taaa larger than 55 mm during the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion. regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. this may be associated to bad outcome and decreased survival rates. by the application of a intraoperative cytokine and damp filter this negative ffect could be reduced, resulting in a better outcome after surgery.

prospecrtive study including 20-30 randomized patients treated by open repair because of an taaa larger than 55 mm during the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion. regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. this may be associated to bad outcome and decreased survival rates. by the application of a intraoperative cytokine and damp filter this negative ffect could be reduced, resulting in a better outcome after surgery.

Eligibility criteria:
inclusion criteria: suffering from a taaa larger than 55mm exclusion criteria: immunosupprive therapy pregnancy -
perioperative administration of pregabalin for pain after mastectomy

Conditions: Pain, Postoperative

Summary: the investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. the primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (vnrs) and total analgesic consumption during postoperative 48 hours. the secondary outcome will be vnrs at 1 week and 1 month after operation.


Eligibility criteria:
inclusion criteria: 1. american society of anesthesia physical status class i \& ii 2. age \> 20 and \< 70 years 3. robot- assisted endoscopic thyroidectomy exclusion criteria: 1. known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications 2. body mass index ≥ 40 kg/m2 3. history of seizure disorder 4. current therapy with pregabalin, gabapentin, or any opioid 5. any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection 6. insulin-dependent diabetes mellitus 7. renal insufficiency (estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73 m2)

Keywords: mastectomy pain, postoperative pregabalin
a study of oral vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a single arm, multicenter, open-label, phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (ipf) currently being treated with pirfenidone.


Eligibility criteria:
inclusion criteria: * have a diagnosis of ipf 5 years from time of screening, confirmed at baseline * tolerated dose of pirfenidone 1602-2403 mg once daily (qd) for a minimum of 24 weeks required prior to and during screening * greater than or equal to (\>=) 50 percent (%) and less than or equal to (\<=) 100% of predicted forced vital capacity (fvc) at screening * stable baseline lung function as evidenced by a difference of less than (\<) 10% in absolute fvc measurements (in liters) between screening and day 1/visit 2 prior to enrollment * \>=30% and \<=90% of predicted diffusion capacity of the lung for carbon monoxide at screening * agree to use protocol defined methods of contraception * male participants must agree not to donate semen during the study and for at least 2 months (or as per local requirements) after the last dose of vismodegib * agree not to donate blood or blood products during the study and for at least 9 months (or as per local requirements) after the last dose of study treatment exclusion criteria: * prior treatment with vismodegib or any hh-pathway inhibitor * evidence of other known causes of interstitial lung disease * hospitalization due to an exacerbation of ipf within 4 weeks prior to or during screening * lung transplant expected within 6 months of screening * evidence of clinically significant lung disease other than ipf * post-bronchodilator forced expiratory volume in 1 second/fvc ratio \<0.7 at screening * any clinically significant medical disease (other than ipf) that is associated with an expected survival of \<6 months, likely to require a change in therapy during the study * class iv new york heart association chronic heart failure or historical evidence of left ventricular ejection fraction \<35% * known current malignancy or current evaluation for a potential malignancy * known immunodeficiency, including, but not limited to, human immunodeficiency virus infection * evidence of acute or chronic hepatitis or known liver cirrhosis * creatinine clearance \<=30 milliliter per minute, calculated using the cockcroft-gault formula

Keywords: idiopathic pulmonary fibrosis vismodegib pirfenidone
hydration to optimize metabolism

Conditions: Glucose, High Blood

Summary: this study evaluates hydration (1.5 l of water daily during 1 year) in the lowering of blood glucose concentration in adults with signs of dehydration (elevated levels of the vasopressin marker copeptin and high urine osmolality). half of participants will in addition to lifestyle advice receive extra water on top of their habitual fluid intake, and the other half (control) will receive only lifestyle advice.

high plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease and premature death. the main physiological role of vasopressin is to maintain constant plasma osmolality. previous studies in rats and mendelian randomization studies in humans suggest causality between elevated vasopressin concentration and elevated plasma glucose concentration. as vasopressin can be suppressed by increasing water intake, we hypothesize that water supplementation in individuals with high vasopressin can lower plasma glucose and prevent diabetes. the aim of this project is to test in a single-centre randomized clinical trial (rct), if water supplementation in subjects with high plasma levels of vasopressin (measured by a stable vasopressin marker of its precursor hormone called copeptin) can reduce fasting levels of glucose (primary outcome measure), risk of new-onset diabetes and other cardiometabolic risk factors (secondary outcome measures).

Eligibility criteria:
inclusion criteria: * provision of informed consent, age 20-75 years with high plasma concentration of vasopressin (plasma concentration of copeptin of \> 6.1 pmol/l in women and \> 10.7 pmol/l in men) and 24 hour urine osmolality \> 600 milliosmol (mosm) /kg water. exclusion criteria: * 24 hour urine volume \> 1.5 l, pregnancy or breastfeeding, plasma sodium \< 135 mmol/l, use of diuretics, lithium or selective serotonin reuptake inhibitor (ssri) drugs, chronic kidney disease (estimated glomerular filtration rate \< 30 ml/min), heart failure, inflammatory bowel disease, type 1 diabetes or type 2 diabetes treated with insulin, vulnerable subjects (subjects with legal guardian, with loss of personal liberty).

Keywords: hydration water vasopressin copeptin glucose ogtt insulin glucagon
pharmacokinetic evaluation of intranasal, intramuscular, and oral naltrexone in healthy volunteers

Conditions: Opioid-Related Disorders

Summary: to determine the pharmacokinetics of 2 intranasal doses and 1 oral dose of naltrexone compared to an intramuscular dose of naltrexone.


Eligibility criteria:
inclusion criteria: * males and females 18 to 55 years of age, inclusive. * provide written informed consent. * bmi ranging from 18 to 30 kg/m2, inclusive. * adequate venous access. * no clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ecg. * male subjects must agree to use an acceptable method of contraception with female partners as well as not to donate sperm throughout the study and for 90 days after the last study drug administration. female subject of childbearing potential must agree to use an acceptable method of birth control throughout the study and for 30 days after the last study drug administration. oral contraceptives are prohibited. * agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., coca cola®, coffee, tea, etc.), or grapefruit/grapefruit juice. * participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study. exclusion criteria: * please contact site for more information
verkes borderline study: the effect of quetiapine on borderline personality disordered patients

Conditions: Borderline Personality Disorder

Summary: in patients with schizophrenia, 'atypical' antipsychotics such as clozapine may be effective in the treatment of psychosis. in patients with borderline personality disorder (bpd), as far as the investigators know, no well designed controlled studies have been performed on the effect of one of the newer atypical antipsychotics on psychotic symptoms. it is of interest to investigate the benefit of quetiapine treatment in these types of patients. quetiapine possibly gives less side-effects because of the expected lack of elevated prolactin levels, which is of importance in this patient group, overrepresented by young females. in this double blind, randomized, placebo controlled, 8 week, parallel group, multi-center study, quetiapine (in flexible doses between 200 mg/day and 600 mg/day) will be compared with the placebo.


Eligibility criteria:
inclusion criteria: * patients with bpd according to diagnostic and statistical manual of mental disorders - fourth edition (dsm-iv)/structured clinical interview for dsm-iv axis ii personality disorders (scid-ii) including criterion 9: transient, stress related paranoid ideation or severe dissociative symptoms. * in- or outpatients exclusion criteria: * depressive disorder * bipolar disorder * schizoaffective disorder/schizophrenia/delusional disorder/schizotypal personality disorder * alcohol- or substance dependence * quetiapine doses \>100mg od use in the past somatic: * history of trauma capitis * visual and auditive disorders * neurological disorders (epilepsy) * pregnancy * no adequate contraception * history of cardial complaints/cardiological disorder * known sensitivity for quetiapine

Keywords: borderline personality disorder
safety and efficacy of 6% hydroxyethyl starch (hes) solution versus an electrolyte solution in patients undergoing elective abdominal surgery

Conditions: Hypovolaemia Due to Acute Blood Loss

Summary: the aim of the study is to investigate the safety of a 6% hes (hydroxyethyl starch) solution (volulyte 6%) versus an electrolyte solution (ionolyte) in patients undergoing elective abdominal surgery.


Eligibility criteria:
inclusion: * male or female adult patients \> 40 and ≤ 85 years of age. women of child bearing potential must test negative on standard pregnancy test (urine or serum) * patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml * asa physical status ii - iii * signed written informed consent form exclusion: * hypersensitivity to the active substances or to any of the other excipients of the investigational medicinal products * body weight ≥ 140 kg * sepsis * burns * renal impairment (akin stage ≥ 1 or chronic) or acute and/or chronic renal replacement therapy * intracranial or cerebral haemorrhage * critically ill patients (typically admitted to the intensive care unit) * hyperhydration * pulmonary oedema * dehydration * hyperkalaemia * severe hypernatraemia * severe hyperchloraemia * severely impaired hepatic function * congestive heart failure * severe coagulopathy * organ transplant patients * metabolic alkalosis * simultaneous participation in another interventional clinical trial (drugs or medical devices studies)

Keywords: hes hes 130 hydroxyethyl starch
magnesium-based bioresorbable scaffold in st segment elevation myocardial infarction

Conditions: Acute Coronary Syndrome; ST Segment Elevation Myocardial Infarction; Stent

Summary: this is a prospective, randomized, active control, single-blind, non-inferiority, multicenter clinical trial. 148 subjects will be registered at up to 10 spanish sites. subjects will be followed for 5 years. all eligible patients (stemi \< 12 hours from onset of chest pain) will be randomized to * biotronik magmaristm sirolimus eluting bioresorbable vascular scaffold system (m-brs) or * biotronik orsiro sirolimus eluting coronary stent system endothelium-independent vasomotor response (ntg injection) will be analyzed at 12 months angiographic follow-up (primary endpoint). in a subgroup of 40 patients optical coherence tomography will be performed after the procedure and at 12 months follow-up. angiographic (qca pre- and post-procedure and at 12 months follow-up), oct data (at 12 months follow-up) will be analyzed off-line by an independent core lab.


Eligibility criteria:
inclusion criteria: clinical: 1. at least 18 years of age. 2. st-segment elevation myocardial infarction documented in an ambulance or in a cathlab, with ≥2 mm st segment elevation in at least two contiguous leads, presenting in the cathlab \<12 hours after the onset of symptoms lasting ≥20 min requiring primary pci. 3. target lesion must be a de-novo lesion located in a native vessel. 4. the patient accepts informed consent 5. the patient understands and accepts clinical follow-up and angiographic control. angiographic: 6. vessel size should match available m-brs scaffold sizes (≥2.75 mm, and ≤3.7 mm by visual assessment). 7. lesion preparation by either manual thrombectomy or pre-dilatation has been successful, with opening of the vessel and timi ≥2 and residual stenosis \<20%. exclusion criteria: 1. pregnancy. 2. known intolerance to aspirin, heparin, stainless steel, sirolimus, and contrast material. 3. distal vessel occlusion after recanalization 4. stemi due to stent/scaffold thrombosis 5. severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal m-brs placement. 6. fibrinolysis prior to pci 7. known thrombocytopenia (plt\< 100,000/mm3) 8. active bleeding or coagulopathy or patients at chronic anticoagulation therapy 9. cardiogenic shock 10. significant comorbidities precluding clinical/angiographic fu (as judged by investigators) 11. major planned surgery that requires discontinuation of dual antiplatelet therapy. 12. diffuse coronary artery disease that will require cabg 13. chronic kidney disease with gfr\<30 ml/min

Keywords: biodegradable stent stemi magnesium bioresorbable vasomotion
value of cardiac rehabilitation on the treatment of cardiovascular disease

Conditions: Cardiac Rehabilitation

Summary: cardiac rehabilitation is a valuable treatment for patients with a broad spectrum of cardiac disease. current guidelines support its use in patients after acute coronary syndrome, coronary artery bypass grafting, coronary stent placement, valve surgery, and stable chronic systolic heart failure. its use in these conditions is supported by a robust body of research demonstrating improved clinical outcomes. despite this evidence, cardiac rehabilitation referral and attendance remains low and interventions to increase its use need to be developed.

the trial was conducted in shenzhen in china. this study will recruit 100 patients with cardiovascular disease with a median and minimum follow-up of 24 and 6 months. patients will be individually randomized to receive either a cardiac rehabilitation program (n = 50) or enhanced standard care involving educational advice (n = 50). the co-primary outcomes are: 1) first occurrence of major adverse cardiovascular events (mace) (composite of all-cause mortality, myocardial infarction, stroke, or emergency cardiovascular hospitalization); and 2) self-rated health on the quality of life-5 dimensions-5 level visual analogue scale.

Eligibility criteria:
inclusion criteria: * cardiovascular disease exclusion criteria: * incalculable tfc * coronary artery spasm or ectasia * lv ejection fraction \< 52% in males or \< 54% in females * abnormal heart structure (congenital heart disease, cardiomyopathies, or valvular dysfunction) * pericardial disease (pericardial effusion or constrictive pericarditis) * previous history of myocardial infarction * uncontrolled hypertension (systolic blood pressure \> 160 mmhg or diastolic blood pressure \> 105 mmhg) * hyperthyroidism * hypothyroidism * malignancy * autoimmune disease * infection * pulmonary, hepatic, and renal disorders * haematological disorders (anaemia, bone marrow involved by neoplastic disease, or red blood cell transfusions)