Kornimate/medical-research-clean huggingface dataset:
the ratio: registry of infections and lymphoma in patients treated with tnf-a antagonists

Conditions: Rheumatoid Arthritis; Crohn's Disease; Ankylosing Spondylitis; Psoriasis

Summary: the ratio registry is a french registry designed by a multidisciplinary group to collect data on opportunistic and severe bacterial infections and lymphoma in patients treated with tnf-a antagonists ( infliximab, etanercept and adalimumab). a total of 486 medical units in metropolitan france participate in the ratio registry. all diagnosis are retained after validation by 2 qualified infectious disease or haematologist physicians (on the basis of the standardized case report form, the hospitalisation summary, and the microbiological and radiological results). risk factors for developing these conditions when treated by tnf-a antagonists will be identified in a case control study. incidence of these diseases will be calculated.


Eligibility criteria:
inclusion criteria for cases: * past or current treatement with tnf-a antagonists * either lymphoma severe bacterial infection opportunistic infection inclusion criteria for controls: * matched with cases by gender, age (+/- 5 years), underlying disease (rheumatoid arthritis, ankylosing spondylitis, crohn's disease, or psoriasis) * past or current treatement with tnf-a antagonists * no lymphoma, severe bacterial infection, opportunistic infection (same as case) exclusion criteria: * none

Keywords: tnf alpha antagonists infections lymphoma safety
catheter ablation therapy for persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: use of catheter ablation for persistent atrial fibrillation (peraf) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). the investigators' previous study indicated that the upper area of the left atrium (la) plays an important role in peraf, with the la roof and mitral isthmus appearing to serve as main substrate in progression from paf to peraf and maintenance of fibrillatory activities. the investigators therefore hypothesized that af should not be initiated or sustained if the latter crucial regions for af maintenance are abolished. this study aimed to describe the efficacy and safety of additional linear ablation on the left atrial anterior wall for peraf.

although studies and guidelines have helped establish catheter ablation as preferred treatment for patients suffering from paroxysmal atrial fibrillation (paf), use of catheter ablation for persistent atrial fibrillation (peraf) remains controversial due to unsatisfactory long-term success rates (15% - 28.4%). the investigators' study indicated that the upper area of the left atrium (la) plays an important role in peraf, with the la roof and mitral isthmus appearing to serve as main substrate in progression from paf to peraf and maintenance of fibrillatory activities. the investigators therefore hypothesized that af should not be initiated or sustained if the latter crucial regions for af maintenance are abolished. this was confirmed using a stepwise pure linear ablation protocol, consisting of a line across the la roof and extending along the anterior wall of pulmonary veins (pv) antrum to mitral valve annulus (mva) without pv isolation; the approach appeared safe and effective with long-term (5.2 years) follow-up success rate of 40% for peraf. this study will evaluate efficacy and safety of circumferential pulmonary vein isolation (cpvi) + la roof linear ablation + la anterior wall (laaw) linear ablation combined with high density mapping and contact force sensing techniques for peraf. this study is expected to provide a practical and guided catheter ablation strategy with maximized safety and efficacy through use of contact force sensing technique, which will be accepted by other qualified electrophysiology laboratories.

Eligibility criteria:
inclusion criteria: - the main inclusion criterion is patients suffering from drug refractory persistent atrial fibrillation and referred to catheter ablation therapy. persistent af is defined as continuous af for over 7 days, or lasting no more than 7 days but requiring pharmacological or electrical cardioversion. exclusion criteria: 1. patients without spontaneous ongoing af at the beginning of the procedure; 2. age: \ 70 years; 3. la size \> 55mm measured on echocardiogram; 4. previous af ablation history including surgical ablation; 5. documented la thrombus; 6. severe pulmonary diseases; 7. previous cardiac surgical history.

Keywords: atrial fibrillation catheter ablation
yttrium-90 (y90) glass microspheres pet/ct in imaging patients with liver tumors

Conditions: Primary Malignant Liver Neoplasm

Summary: this clinical trial studies how well yttrium-90 (y90) glass microspheres positron emission tomography (pet)/computed tomography (ct) works in imaging patients with liver tumors . images produced by pet/ct may provide better information about the distribution of particles, such as y90 glass microspheres, delivered for selective internal radiation therapy (sirt) as compared to regular medical care images useing technetium tc-99m albumin-aggregated single photon emission computed tomography (spect)/ct images.

primary objectives: i. to evaluate the image quality of yttrium-90 (y90) microspheres pet/ct post sirt images as compared to technetium tc-99m albumin aggregated (99mtc maa) spect/ct. secondary objectives: i. to determine the superior accuracy in both distribution and dosimetry of y90 pet/ct post-sirt imaging compared to 99mtc maa planar and spect/ct imaging. outline: immediately after standard of care sirt, patients receive y90 glass microspheres and undergo pet/ct over 30 minutes. this study compares the experimental images to the regular medical care images in the same participant.

Eligibility criteria:
inclusion criteria: * patient provides written informed consent * patient is referred for 90y sirt radioembolization of liver tumor(s) * patient is capable of complying with study procedures * patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital pet/ct) exclusion criteria: * patient is pregnant or nursing
intravenous infusion of prostaglandins as therapy in patients with anterior non-arteritic ischemic optic neuropathy

Conditions: Ischemic Optic Neuropathy

Summary: correction of the deficit in the perfusion pressure of the microcirculation that supplies the nerve by intravenous infusion of prostaglandin e1 (pge1) (alprostadil), expected to improve visual function in patients with ischemic optic neuropathy previous non-arteritic (noiana).


Eligibility criteria:
inclusion criteria: * patients of both sexes between the ages of 50 and 80, both inclusive. patients with the first episode of ischemic optic neuropathy previous non-arteritic / noiana. patients with noiana with an evolution time from the beginning of the clinic less than or equal to 15 days. * potentially fertile patients should have a negative pregnancy test in serum (beta-hcg / human chorionic gonadotropin) or urine. * patients who offer sufficient guarantees of adherence to the protocol. * patients who give written informed consent to participate in the study. exclusion criteria: * patients with previous optic of any etiology in the affected eye. * patients with previous diagnosis or symptoms at the time of arteritis of the temporal artery. * patients with optic neuropathy with bilateral clinical presentation of any etiology. * patients with loss of vision due to acute hypotension in the context of a surgical intervention, acute hemorrhage or hemodynamic shock. * patients with severe loss of previous vision in the eye affected by ophthalmologic causes: severe cataract, glaucoma or intraocular pressure greater than 30 millimeters of mercury, severe diabetic retinopathy, macular degeneration associated with severe age. * patients with clinical onset in the month following major non-ocular or intraocular surgery * patients with abnormal elevation of crp / c-reactive protein (\> 2 times the upper limit of normal) * patients with creatinine levels above 1.5 mg / dl. * patients on steroid treatment in the month prior to the episode. * patients under treatment with oral anticoagulants. * patients on treatment with hydroxychloroquine, ethambutol, vigabatrin at any time before the episode. * patients in whom the use of pge1 (alprostadil) is contraindicated: * patients with participation in a clinical trial in the last 6 months. * patients with inability to understand informed consent. * pregnant patients, in the postpartum period or during the active lactation period. * physically fertile patients
training nurses in basic hypnoanalgesia techniques

Conditions: Cancer

Summary: demonstrate that a 4-day training session will allow nurses to master basic hypnoanalgesia techniques, and this new tool will translate into a reduction of procedural distress and pain in their patients, thereby opening the way to larger clinical trials in various pediatric settings.


Eligibility criteria:
inclusion criteria: * children followed in the hematology-oncology outpatient clinic at least 4 times per year * good understanding in french * use of topic anesthesia or distraction object allowed, as long as used at all venipuncture measured sessions exclusion criteria: * prior use of hypnoanalgesia * patients coming for emergency or non-scheduled appointment * patients with acute pain on their scheduled appointment to the clinic * acute psychiatric disease
post-marketing surveillance of micombi tablets survey on the long-term use

Conditions: Hypertension

Summary: the survey is conducted to collect safety and effectiveness information in hypertensive patients treated with micombi tablets on the long term use in daily clinical settings in japan.


Eligibility criteria:
inclusion criteria: hypertensive patients who have never taken micombi tablets. exclusion criteria: none
does cranioplasty reduce disability in cases with post traumatic skull bone defects

Conditions: Cranioplasty; Disability Physical; Trauma

Summary: background: the percentage of permanent infirmities following traumatic cranial bone cranial bone defects following trauma for restoration of function and cosmoses. this study designed to evaluate the influence of cranioplasty as a method of skull repair on work capability of the patients and their employability. methods: the authors compared the work capability and employment of 35 patients with traumatic cranial bone defects after head trauma treated in the neurosurgery department of assiut university hospitals, egypt from january 2013 to january 2018 before and after cranioplasty.

cranioplasty is surgical repair of a cranial bone defect, important to cover defects following skull trauma for restoration of function, cosmoses and protective effects. cranioplasty is the surgical procedure in which the autologous skull, synthetic materials (titanium, methyl methacrylate, polyetheretherketone implants, hydroxyapatite, and bioceramics are used to repair the skull defect

Eligibility criteria:
inclusion criteria: • patients with traumatic skull bone defects exclusion criteria: • patients were not working before trauma

Keywords: cranial defect skull bone defects
evaluating the impact of vagus nerve stimulation on diabetic peripheral neuropathic pain

Conditions: Diabetes Mellitus; Diabetic Neuropathies; Type2diabetes; Neuropathic Pain

Summary: the purpose of the study is to investigate the effects of non-invasive invasive vagal nerve stimulation on diabetic peripheral neuropathic pain in people with diabetes.

the study is a randomized, double-blinded, sham-controlled, parallel-group clinical trial, which will include participants with diabetic peripheral neuropathic pain. participants are randomized to receive either active non-invasive transcutaneous vagal nerve stimulation (tvns) or inactive sham stimulation. the study will investigate the effects of short-term, high-intensity tvns treatment on peripheral pain. the primary outcome is subjective patient evaluation of pain symptoms by the use of validated questionnaires.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus \> 1 year * patients experiencing neuropathic pain exclusion criteria: * patients with co-morbidities such as chronic pain from other conditions * patients with serious complications of diabetes such as nephropathy and retinopathy
negative pressure drainage system split-thickness skin graft recipient sites

Conditions: Wound Healing of STSG

Summary: to compare the efficacy and safety of negative pressure drainage system with controls (indirect saline soaks) in the coverage of recipient site wounds of split-thickness skin graft.

randomized, comparator-controlled trial in patients underwent split-thickness skin graft conducted in taipei veterans general hospital between aug. 2012 and dec. 2013. (no.) patients age 21 to 60 years were randomly assigned in the intervention group (n= ) of negative pressure drainage system or to a control group (n= ) of traditional method. patients who had immunologic disease, end-stage renal disease, coagulopathy, or history of radiation were excluded. the conditions of graft take and pain and discomfort were compared every day during the first 7 days after operation and 2 weeks and 3 months follow up.

Eligibility criteria:
inclusion criteria: * aged 21 to 60 years * the wounds located on limbs or trunk * the area of wounds is ranged 50 to 250cm2. exclusion criteria: * immunodeficiency disease * end stage renal disease * coagulopathy * history of radiation to the recipient site * allergy to the dressing * major medical problems

Keywords: stsg wound healing
effect of adding modified ketogenic diet to exercise program in treating obese patient with multiple sclerosis: a randomized controlled trial

Conditions: Multiple Sclerosis

Summary: this study will be conducted to investigate the effect of adding modified ketogenic diet to exercise program in treating obese patient with multiple sclerosis.

multiple sclerosis (ms) is the most common inflammatory disease of the central nervous system in young adults that may lead to progressive disability. since pharmacological treatments may have substantial side effects, there is a need for complementary treatment options such as specific dietary approaches. ketone bodies that are produced during fasting diets (fds) and ketogenic diets (kds) are an alternative and presumably more efficient energy source for the brain.ketogenic diets (kds) are high-fat, low-carbohydrate diets that mimic a fasting state. kds create a metabolic shift from glycolytic energy production toward oxidative phosphorylation energetics by using fatty acids as a primary source of energy. as these fatty acids undergo beta-oxidation, ketones are produced. this increase in oxidative phosphorylation coupled with ketone production modifies the tri carboxylic acid cycle to limit reactive oxygen species generation. in addition, ketone bodies transported across the blood-brain barrier up regulate antioxidant pathway genes (particularly via the nrf2 pathway) and boost energy production in brain tissue.sixty-four subjects with ms, ranged from 18-50 years. will be selected randomly divided into two groups each group consists of thirty-two subjects; experimental group (modified ketogenic diet+ aerobic exercise) and control group (aerobic exercise).

Eligibility criteria:
inclusion criteria: * confirmed ms based on mcdonald criteria. * patients had to be fully ambulatory, not requiring assistive devices. * the ages of 18 and 50 * patients body mass index (bmi) less than 30 kg/m2. exclusion criteria: * evidence of active disease or relapse phase within the last 30 days * chronic heart failure, cancer, chronic kidney disease, infection with human immunodeficiency * addiction to drugs or alcohol. * pregnancy and diabetic patient.

Keywords: modified ketogenic diet multiple sclerosis
metabolic effects of a low carbohydrate versus a standard diet in morbidly obese with prediabetes

Conditions: PreDiabetes; Obesity, Morbid; Bariatric Surgery Candidate

Summary: to investigate the metabolic effects of a low carbohydrate versus energy-matched standard diet in morbidly obese individuals with prediabetes awaiting bariatric surgery.

the metabolic benefits of calorie restriction in obese people with or without impaired glycaemia are well-established. the impact of diet composition, however, remains poorly understood. hepatic lipid content strongly correlates with hepatic insulin resistance, which is a key feature of the pre-diabetic state. the investigators hypothesize that a low carbohydrate diet compared to an energy-matched standard diet in morbidly obese patients with prediabetes scheduled for bariatric surgery results in greater reduction in liver fat.

Eligibility criteria:
inclusion criteria: * female and male subjects aged 18 years or older * bmi \>35 kg/m2 awaiting bariatric surgery * pre-diabetes according to american diabetes association criteria (hba1c 5.7%-6.4%) * capacity to give informed consent and adhere to study procedures exclusion criteria: * excess alcohol consumption (\> 3 units/day for men, \> 2 units/day for women) * moderate to severe kidney disease * nephrolithiasis * pregnancy/breastfeeding * current participation in another clinical trial * claustrophobia * mri-contraindications (pacemaker/defibrillator, neurostimulator, drug pump, cochlear implant, heart valve/vascular clips, shunt valve)

Keywords: prediabetes bariatric surgery low-carb diet
gen-001 in combination with avelumab for patients with pd-l1 positive gastric cancer

Conditions: Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Summary: this is a phase ii, multicenter, open-label study to evaluate the antitumor activity, efficacy and safety of gen-001 in combination with avelumab as a third line (3l) or greater line treatment which is not received the standard of care (soc) for patients with pd-l1 positive advanced gc/gastroesophageal junction adenocarcinoma who are not received cancer immunotherapy regimens as mono or combination therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed unresectable, recurrent, locally advanced or metastatic gc/gastroesophageal junction adenocarcinoma * eastern cooperative oncology group (ecog) performance status of 0 or 1 * have adequate organ functions as defined in the protocol * negative childbearing potential * have experienced documented objective radiographic or clinical disease progression after 2 or above previous lines of standard therapy. * pd-l1 positive * measurable disease as per recist v1.1 defined as at least 1 lesion * estimated life expectancy of at least 3 months * have ability to swallow and retain oral medication and no clinically significant gastrointestinal abnormalities exclusion criteria: * previously received t-cell coregulatory protein inhibitors * has clinically significant evidence of ascites by physical exam * known prior severe hypersensitivity reactions to monoclonal antibodies or any component in their formulation * has active autoimmune disease that has required systemic treatment in the past 2 years * current use of immunosuppressive medication * have an active infection requiring antibiotics, antifungal or antiviral agents or have received a course of antibiotics within 4 weeks * has received a live vaccine within 4 weeks * known history or any evidence of active for non-infectious pneumonitis * prior solid organ or allogeneic stem cell transplantation * has had any investigational or anti-tumor treatment within 4 weeks or 5 half-life periods of starting study treatment, had any major surgeries within 4 weeks * has received proton pump inhibitors (ppis) within 2 weeks * has known active central nervous system (cns) metastases and/or carcinomatous meningitis * has clinically significant (i.e., active) cardiovascular disease * has other persisting toxicities * has other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, or psychiatric conditions
short-term and oncological outcomes of laparoscopic colorectal cancer surgery in obese patients

Conditions: Obesity; Colorectal Cancer

Summary: a total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (crc) were included in the present study. subjects commonly shared a condition of overweight or obesity. the investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, lymph nodes number, intra-surgery complications, and clavien dindo score.

a total of 138 consecutive patients who underwent laparoscopic-assisted or open colectomy for colorectal cancer (crc) were included in the present study. intra-surgery complications, previous surgery, readmission post intervention, location of surgery, duration of surgery, re-intervention (yes), clearance, and crm were collected. subjects commonly shared overweight or obesity. the investigators aimed to define any difference between the two different groups (open vs laparoscopic-assisted surgery) and a series of outcomes, i.e. hospitalization, lymph nodes number, intra-surgery complications, and clavien dindo score.

Eligibility criteria:
inclusion criteria: * body mass index \>25 kg/m2 * colorectal cancer (crc) exclusion criteria: * current emergency conditions (i.e., perforation and\\or occlusion) * pregnancy, * co-existing peritoneal carcinomatosis * contraindications to ls, such as cardiorespiratory comorbidities (chd, chf, and other severe cvd) * prior transverse resections
sublingual sufentanil vs intravenous fentanyl for acute pain in the ambulatory surgery center

Conditions: Pain; Pain, Acute; Anesthesia

Summary: the purpose of this study is to determine if a single dose of sublingual sufentanil is as or more efficacious than a single dose of iv fentanyl in a post anesthesia care setting.

this is a level i randomized prospective outcomes study comparing two groups of patients. upon arrival in the ambulatory surgery center (asc) post-anesthesia care unit (pacu) if the patient has a pain score of 4 or greater they will then be randomized to one of two groups. group 1 will receive 50 mcg of iv fentanyl and group 2 will receive 30 mcg of sublingual sufentanil. the primary outcome assessed will be time of readiness to discharge after arrival in the post-anesthesia care unit.

Eligibility criteria:
inclusion criteria: * undergoing outpatient ambulatory surgery * recipient of general anesthesia * pain score of 4 or greater in the pacu exclusion criteria: * non-english speaking patients * cancer surgeries * patients who have allergy or intolerance to the study drugs or derivatives * patients on chronic opioids (defined as daily opioids for 3 months or longer)