Kornimate/medical-research-clean huggingface dataset:
pacman - pacing for cardiomyopathies, a european study

Conditions: Heart Failure

Summary: the purpose of this study was to evaluate the benefit of biventricular pacing in patients with heart failure who were receiving optimal pharmacological therapy, and who were either with or without an icd indication

heart failure is a syndrome that affects millions of patients in europe with over half a million new cases reported annually. drug therapy had been the conventional treatment of choice until the emergence of cardiac resynchronization therapy (crt) where biventricular pacing can be delivered to the heart through a pacemaker or implantable cardioverter defibrillator. this study was designed to assess the effect of crt on patients optimized on conventional heart failure medication including diuretics, beta blockers and ace inhibitors. the effect of crt was evaluated by comparison of 6 minute walk performance, quality of life and nhya class after 6 months with crt therapy either programmed on or off. in addition, evaluation of the incidence of adverse events (predefined as ventricular arrhythmias, hospitalizations, drop-outs, complications and patient deaths) was done between groups at 6 months. patients were all programmed on after 6 months and data was collected for an additional 6 months.

Eligibility criteria:
inclusion criteria: - nyha class iii and iv with ef \< 35%; optimal individual drug therapy in 2 weeks prior to enrollment including ace inhibitors; beta blockers and diuretics unless not tolerated exclusion criteria: * reduced life expectancy of \< 6 months or candidate for heart transplant within 6 months; chronic/recurrent atrial fibrillation/flutter
early versus delayed laparoscopic cholecystectomy following ercp in concomitant gallstones and common bile duct stones

Conditions: Choledocholithiasis With Cholecystitis

Summary: the present study aimed to compare early and delayed laparoscopic cholecystectomy after ercp for cbds and gallstones.

endoscopic retrograde cholangiopancreatography (ercp) followed by laparoscopic cholecystectomy (lc) is a commonly performed treatment modality for concomitant common bile duct stones (cbds) and gallbladder stones. there has been a debate about the appropriate timing of laparoscopic cholecystectomy after ercp. the present study aimed to compare early and delayed laparoscopic cholecystectomy after ercp for cbds and gallstones adding new parameters like nassar scale.

Eligibility criteria:
inclusion criteria: * patients who underwent laparoscopic cholecystectomy after clearance of cbds by ercp exclusion criteria: * advanced liver cirrhosis, pancreatitis, acute cholangitis, suspected malignancy, severe malnutrition, and pregnancy.

Keywords: choledocholithiasis early delayed laparoscopic cholecystectomy ercp nassar scale
clinical trial to evaluate the tolerability and efficacy of microencapsulated calcium carbonate

Conditions: Hypocalcemia; Dietary

Summary: interventional clinical trial with food supplement, randomized, double-blind, comparative between microencapsulated calcium, calcium carbonate salts standardized and calcium citrate, in a population of postmenopausal women, lasting 1 month.


Eligibility criteria:
inclusion criteria: * postmenopausal woman * low contribution of elemental calcium in the daily diet exclusion criteria: * hypersensitivity to the active substances or to any of the excipients * renal insufficiency * history of kidney or urinary stones * use in the last month of diuretics (furosemide, ethacrynic acid), aluminum salts and / or thyroid hormones * use of any other drug or experimental device during the 30 days prior to the selection
variation in acute appendicitis during covid-19 pandemic in italy

Conditions: Acute Appendicitis

Summary: retrospective observational study of variation in incidence and clinical presentation of appendicitis during the pandemic in northern italy, compared with the same period in the previous 2 years.


Eligibility criteria:
inclusion criteria: * acute appendicitis exclusion criteria: * other diagnosis
safety and efficacy of pb-119 in subjects with type 2 diabetes and not well-controlled by metformin monotherapy

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: this is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of pb-119 to subjects with type 2 diabetes mellitus (t2dm) not well-controlled by metformin monotherapy.

this is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of pb-119 to patients with t2dm not well-controlled by metformin monotherapy. patients will be assessed for eligibility over a 2 week screening period prior to a 4-week run-in period,a 24-week double-blind treatment period and a 28-week open-label treatment period. the eligible patients will be randomized to pb-119 or placebo cohort at a 1:1 ratio for the first 24-week. patients in pb-119 group will subsequently be given active drug and patients in placebo group will take placebo, all patients in two groups will remain metformin background therapy. in the 28-week open-label period, all patients will be administered active drugs. after that, there will be a 4-week follow-up period; all randomized patients will be taken blood samples for the pharmacokinetic (pk) analysis.

Eligibility criteria:
inclusion criteria: * male or female, aged 18\~75 years old; * t2dm and treated with metformin ≥ 1500mg/day or maximum tolerated dose(≥1000mg,\<1500mg) constantly for at least 8 consecutive weeks; * 7.5% ≤ hba1c ≤ 10.0% at screening; * 18.5 kg/m2 \< bmi \< 40.0 kg/m2 at screening; exclusion criteria: * any anti-diabetic therapy other than metformin within 8 weeks before screening； * t1dm; * received insulin therapy more than 14 days within 1 year before screening; * female who is pregnant, breast-feeding; * any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol; * history of acute diabetic complications, such as diabetic ketoacidosis or hyperglycemic hyperosmolar status within 6 months before screening； * history or presence of pancreatitis (acute or chronic); * presence or history of malignant neoplasms within the past 5 years prior to the day of screening
rivaroxaban utilization for treatment and prevention of thromboembolism in cancer patients: experience at a comprehensive cancer center

Conditions: Cancer; Deep-vein Thrombosis of the Lower and Upper Extremities; Pulmonary Embolism; Non-valvular Atrial Fibrillation

Summary: the primary objective of this study is to evaluate the practice patterns of rivaroxaban usage invenous-thromboembolism (vte) and non-valvular atrial fibrillation (nvaf) in cancer patients. the secondary objectives are to evaluate outcomes such as recurrent vte, stroke and bleeding for cancer patients on rivaroxaban.

this retrospective descriptive study will review charts of approximately 375 cancer patients prescribed rivaroxaban from january 1, 2012 to november 7, 2016 at ut mdacc for nvaf or patients that had prior vte and diagnosis of cancer. the list of patients prescribed rivaroxaban during the study period will be obtained from pharmacy informatics. we will review the eligibility of all patients on the pharmacy list who were prescribed rivaroxaban during the study time-frame. the eligible patients who meet inclusion/exclusion criteria will be identified. all available data concerning demographic, clinical parameters and rivaroxaban usage will be collected for eligible patients from pharmacy informatics, cs, laboratory informatics, and clinical informatics databases. the variables of interest include demographic information, clinical parameters (tumor type, extent of disease, clinical exam findings, and presence of comorbidities, diagnostic assessments, and treatment interventions), reason for rivaroxaban discontinuation and outcomes. the confidentiality of all patient-specific data will be maintained. by using pharmacy informatics and cs, we can capture most of patients prescribed rivaroxaban at the ut mdacc.this is a descriptive study and the final sample size will depend on available records for chart review from 01/01/2012 to 11/07/2016.

Eligibility criteria:
inclusion criteria: 1. age range: patient must be ≥ 18 years. 2. male and female patients will be eligible for enrollment. 3. patients diagnosed with deep-vein thrombosis of the lower and upper extremities, pulmonary embolism or both or with non-valvular atrial fibrillation. 4. patients must have active malignancy defined as a diagnosis of cancer (excluding basal cell squamous cell carcinoma of the skin) within six months before enrollment, have received any treatment for cancer within the previous six months or have documented recurrent or metastatic cancer . exclusion criteria: 1. patients who are on hemodialysis 2. patients with valvular heart disease (using a coexisting prosthetic heart valve or have a hemodynamically significant valve disease)

Keywords: cancer deep-vein thrombosis of the lower and upper extremities pulmonary embolism non-valvular atrial fibrillation chart review vte nvaf rivaroxaban
safety and efficacy of infrared diode laser on improvement of scar and prevention of recurrence of excised keloid

Conditions: Keloid; Surgical Scar

Summary: a pilot study will be conducted on 2 type of subjects, one with plastic surgery scar with a randomization of laser treated portions, and other with keloid excision scar with a complete laser treatment. the aim is to evaluate the infra-red diode laser influence on keloid recurrence and scar prevention. the keloid recurrence rate will be evaluated at each visit, and the scar prevention in plastic surgery will be evaluated comparing laser treated portion and non-treated portion.


Eligibility criteria:
inclusion criteria: * 18 years and older * skin type from i to vi (fitzpatrick classification scale) * scar longer than 4cm for plastic surgery's patients or scar longer than 2cm for keloid patients exclusion criteria: * malignant tumor pathology * infectious or viral skin disease * immunosuppressive pathology and/or immunosuppressive treatment, * long-term corticosteroid treatment * pregnant woman

Keywords: laser keloid scar
a double-blind confirmatory trial of levetiracetam in epilepsy patients with partial onset seizures

Conditions: Epilepsies, Partial

Summary: a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluated the efficacy and safety of levetiracetam used as adjunctive treatment in patients from 16 to 65 years with epilepsy suffering from partial onset seizures.


Eligibility criteria:
inclusion criteria: epileptic patients who fulfill the following criteria are eligible for inclusion in the study: * subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation * seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to "clinical and electroencephalographic classification of epileptic seizures (1981)" defined by the international league against epilepsy (ilae) and confirmed with an eeg that has been performed within 1 year before screening or at the screening visit * subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (aeds) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months * frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the baseline period (week -12 to week 0) and at least twice in every 4 weeks exclusion criteria: the following patients are not eligible for inclusion into the study: * subjects who were diagnosed with status epilepticus within 3 months before screening * subjects with no partial seizures of which frequency was measured during the baseline period * subjects who underwent surgery for epilepsy within 2 years before screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study * subjects with a history of oral treatment with levetiracetam (lev)

Keywords: epilepsies, partial, keppra, levetiracetam
on-demand use of pantoprazole: determinants for chronic use of acid suppressive medication

Conditions: Chronic Use of Acid Suppressive Medication; GORD; GERD; Reflux; Peptic Ulcer

Summary: the purpose of this study is to investigate several aspects of chronic use of acid suppressing medication: dependence on maintenance therapy, the possibilities for on-demand use, and predictors (patient characteristics) for daily need, for on-demand use and for termination of chronic use.

2-5% of the general population is chronic user of acid suppressing medication (proton pump inhibitors, h2 receptor antagonists), mostly because of gastro-oesophageal reflux disease (gord). prescription data from health insurances show that the number of chronic users increases every year, which has large economic consequences. there are indications however that on-demand and intermittent therapy can be as effective as daily use. no evidence exists regarding patients who are likely to benefit from intermittent, on-demand therapy or even termination. in this study several aspects of chronic use of acid suppressive therapy are investigated in family practice patients. chronic users are transferred to pantoprazole 20 mg for 4 weeks. patients with adequate relief of symptoms are randomized in two groups for a period of 13 weeks. group 1: daily pantoprazole 20 mg, placebo on-demand (indicative for placebo-dependency) group 2: daily placebo, pantoprazole 20 mg on-demand (indicative for pharmacological dependency) patients visit the research nurse at the beginning of the study and at week 4, 5, 10 and 17. in this study we are looking for patient characteristics indicative for the dependency on acid suppressive drugs and for possibilities to reduce the dose of these drugs. furthermore, aspects described in "secondary outcomes" will be addressed.

Eligibility criteria:
inclusion criteria: * male and female (non-pregnant, non-lactating)out-patients between 18-75 * chronic users of acid suppressive therapy for at least 180 days over the last year exclusion criteria: * stage 3, 4 oesophagitis, barrett's oesophagus, acute peptic ulcer * gastric hypersecretory condition, predominantly ibs symptoms, previous gastric/oesophageal surgery, pyloric stenosis * severe, unstable comorbidities * alarm symptoms * malignancies in the past 5 years * use of nsaid, systemic glucocorticoids, cox-2 inhibitors, acetylsalicylic acid more than 150 mg daily, drugs with ph-dependent absorption, anticholinergics

Keywords: on-demand therapy pantoprazole gastro-oesophageal reflux disease proton pump inhibitor acid suppression intermittent
ixekizumab concomitantly administered with tirzepatide in adults with psoriatic arthritis and obesity or overweight

Conditions: Psoriatic Arthritis; Obesity

Summary: the main purpose of this study is to demonstrate that when participants with psoriatic arthritis and obesity or overweight in the presence of at least 1 weight-related comorbid condition receive ixekizumab and tirzepatide concomitantly administered, participants see improvement in their psoriatic arthritis and achieve weight reduction compared to when receiving ixekizumab. participation in this study includes up to 12 visits and could last up to 61 weeks including screening, open label treatment period, and post-treatment follow-up period.


Eligibility criteria:
inclusion criteria: * have signs and/or symptoms or documented diagnosis of psoriatic arthritis (psa) for at least 6 months and currently fulfilling the classification of psoriatic arthritis (caspar) criteria. * have active psa, defined as the presence of at least 3 of 68 tender joints and at least 3 of 66 swollen joints. * have obesity, body mass index of ≥30 kilograms per meter squared (bmi ≥30 kg/m²) or overweight (bmi ≥27 to \<30 kg/m²) in the presence of at least 1 of these weight-related comorbid conditions (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or t2dm). exclusion criteria: medical conditions * have type 1 diabetes mellitus (t1dm). * have insulin-treated type 2 diabetes mellitus (t2dm). * have a prior or planned surgical treatment for obesity. * have a family or personal history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia (men) syndrome type 2. * have active, or a history of inflammatory bowel disease (crohn's or ulcerative colitis). * have a diagnosis or history of malignant disease within the 5 years prior to randomization, with the following exceptions: * basal cell or squamous epithelial carcinomas of the skin that have been resected, with no evidence of metastatic disease for 3 years. * cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to randomization. * have a serious disorder or illness other than psa. * have a history of chronic or acute pancreatitis. * have any prior use of ixekizumab or tirzepatide. * diagnosis of other inflammatory arthritis, such as rheumatoid arthritis (ra), ankylosing spondylitis, reactive arthritis, gout, or enteropathic arthritis. * have a previous failure or intolerance to an interleukin 17 inhibitor (il-17i) or glucagon-like peptide 1 (glp-1) receptor agonists.
effect of individualized versus standard bp management during mt for anterior ischemic stroke

Conditions: Acute Cerebrovascular Accident

Summary: determine is a multicenter, prospective, randomised, open, blinded end-point assessed (probe) trial, to evaluate two approaches of blood pressure (bp) management during mechanical thrombectomy for acute ischemic stroke due to an anterior large vessel occlusion.

this study have to objective to evaluate the efficacy of an individualized bp control during mechanical thrombectomy (regardless of the sedation modality), by maintaining a mean arterial pressure (map) within 10% of the first map measured in the angiography suit, compared to the standard bp management, on the 3-month functional outcome.

Eligibility criteria:
inclusion criteria: * age \>18 years old * acute ischemic stroke due to an anterior large vessel occlusion: occlusion of the m1 or m2 segments of the middle cerebral artery, anterior cerebral artery (a1 segment), intracranial internal carotid artery, or tandem occlusions. * indication for mechanical thrombectomy under general anesthesia or conscious sedation within the first 6 hours from symptoms onset or within the first 24 hours if dawn or defuse-3 criteria are met. * affiliation to social security assurance. exclusion criteria: * contre-indication to mechanical thrombectomy * intubation or induction of general anaesthesia prior to randomization * acute ischemic strokes associated with a posterior circulation large vessel occlusion (basilar artery, vertebral artery, posterior cerebral artery) * intra-hospital onset of acute ischemic stroke, or secondary to a medical, interventional or surgical procedure (interventional cardiology, cardiac or vascular surgery) or any post-surgery ischemic stroke. * pre-existing neurological disability limiting neurological assessment at 3 months: mrs \>2 at randomization. * contraindication to iodinated contrast agents * known pregnancy or breastfeeding woman

Keywords: acute ischemic stroke large vessel occlusion mechanical thrombectomy blood pressure management brain infarction endovascular procedure thrombectomy blood pressure low blood pressure hemodynamic hypertension
different doses of ivig for kawasaki disease

Conditions: Kawasaki Disease

Summary: the objective of this study is to investigate the effect of different doses of intravenous immunoglobulin (ivig) (1g/kg once, 1g/kg twice, 2g/kg once) for kawasaki disease (kd) in a multicentre, prospective,randomised trial.

kawasaki disease is an acute febrile illness recognized most often in young children. coronary abnormality is the most serious complication preventable with intravenous immunoglobulin (ivig) administration. various treatment regimens of ivig have been reported.the optimal administrative doses of ivig deserves more observations.we will conduct a multicenter, randomized, prospective trial to determine the effect of different doses of ivig (1g/kg once, 1g/kg twice, 2g/kg once) for kawasaki disease. the kd children will be randomly assigned to three groups and were given different ivig regimen (1g/kg once, 1g/kg twice, 2g/kg once)as initial treatment. patient age, gender, white blood cell count, hemoglobin, erythrocyte sedimentation rate (esr), c-reactive protein (crp), red blood cell specific volume (hct) , serum albumin, the fever days,and the cost of hospital stay will be analyzed among the three groups. the primary outcome is the duration of fever subsided and the incidence of coronary artery lesions .

Eligibility criteria:
inclusion criteria: * individual patient's medical file data confirmed the diagnosis of kd using the 5th revised edition of diagnostic criteria for kd, issued by the japan kawasaki disease research committee at the 7th international kawasaki disease symposium in 2002. * the patients aged from 1 months to 12 years old. * all included patients required to sign an informed consent form. * the patients didn't receive treatment before. exclusion criteria: * the patients with the application of hormone or other immunosuppressive agents; * the patients didn't want to signed informed consent.

Keywords: kawasaki disease ivig