Kornimate/medical-research-clean huggingface dataset:
epiretinal membrane peeling and internal limiting membrane

Conditions: Epiretinal Membrane; Macular Pucker; Internal Limiting Membrane

Summary: to study and compare visual acuity in patients undergoing removal of the epiretinal membrane with and without the removal of the internal limiting membrane at baseline versus 6 month.

this prospective cohort study includes 2 arms : with and without internal limiting membrane (ilm) peeling. each patient undergo the same procedure : first of all pars plana vitrectomy, then internal limiting membrane peeling is performed and facilitated by the use of dye, which aids in better visualization of the ilm. if the ilm is removed in same time : the patient is ranked in the "ilm peeling" group if the ilm is not removed : the patient is ranked in the "non ilm peeling" group. if the ilm is partially removed, the patient is not enrolled. the outcomes are recorded for 6 months : at baseline, day 15, 1, 3 and 6 months.

Eligibility criteria:
inclusion criteria: * adult up to 18 years old, * diagnosed and treated surgically exclusion criteria: * proliferative diabetic retinopathy, * ocular trauma, * central veinous occlusion, * intra-ocular tumor, total retinal detachment, * central visual field loss in glaucomatous patients

Keywords: epiretinal membrane epiretinal membrane peeling macular pucker internal limiting membrane (ilm) peeling pars plana vitrectomy
the acute and long-term clinical outcome of self- expandable stent in complex proximal superficial femoral artery lesions involving the femoral bifurcation

Conditions: Common Femoral Artery Occlusive Disease

Summary: the stent-fp study investigates the impact of coverage of profound femoral artery (pfa) by bare metal stent deployed in proximal superficial femoral artery (sfa) lesions. 300 patients with femoral bifurcation lesions will be included and divided into 3 groups according to the location of proximal stent edge. the primary endpoint of the study is major adverse events and freedom from target lesion revascularization at 48 months. secondary endpoints include primary patency of pfa and bare metal stent at 1,6, 12,24,36and 48 month, mae and f -tlr at 1,6, 12,24,36 month.


Eligibility criteria:
inclusion criteria: 1. patients with chronic atherosclerosis obliterans aged over 18 years 2. patients presenting rutherford classification from 2-5 3. patients is willing to follow-up on time 4. patient has a life expectancy of at least 24 months 5. prior to enrolment, the guidewire has crossed target lesion 6. de novo lesions located in the femoral artery bifurcation (5mm between distal cfa and proximal sfa), need for primary bare metal stent implantation 7. there is a patent deep femoral artery demonstrated by angiography 8. if the first-time endovascular treatment is failure, patients undergo endovascular treatment successfully at the second time, the patients can still be enrolled （9）for patients with aortoiliac artery lesions, they can be enrolled after the successful reconstruction of aortoiliac artery . (10) the lower extremity artery needs to have a healthy runoff of no less than 10 cm above the ankle, and at least one healthy dorsalis pedis artery, medial or lateral plantar artery connected with the digital artery below the ankle (11) informed consent signed by patients exclusion criteria: 1. patients who are known to be allergic to heparin, low molecular weight heparin, contrast agents, etc. 2. in the past 3 months, they have participated in other drugs that interfere with this clinical trial or patients in clinical trials of medical devices 3. pregnant and lactating women 4. patients with other diseases that may make the trial difficult or significantly shorten the patient's life expectancy (\<2 years), such as tumors, severe liver disease, cardiac insufficiency, etc or patients whose life expectancy is less than 24 months (24 months of follow-up are required) 5. patients with acute arterial thrombosis or embolism at the target lesion site. 6. patients who underwent stent implantation in common femoral artery previously (8) use of thrombectomy, atherectomy or laser devices during procedure (9) previous open surgery in the same limb . (10) patients with deep femoral artery totally occlusion

Keywords: common femoral artery occlusive disease the bare metal stent profound femoral artery patency
two different surgical techniques on postoperative circumcision pain

Conditions: Postoperative Pain

Summary: to compare the effect of two different surgical techniques, the dorsal slit and double incision technique, on postoperative pain.

two different circumcision techniques result in different kinds of pain.this research aims determine which is more beneficial to the patient.

Eligibility criteria:
inclusion criteria: * children exclusion criteria: * patients with any bleeding

Keywords: circumcision postoperative pain
haic plus a+t for patients with high-risk hcc: a single-arm phase 2 trial

Conditions: Hepatocellular Carcinoma

Summary: atezolizumab plus bevacizumab is the first-line treatment for patients with advanced hepatocellular carcinoma. however, the prognosis for high-risk hepatocellular carcinoma is still poor, with a median overall survival of 7.6 months. hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin is effective in large hepatocellular carcinoma or hepatocellular carcinoma with major portal vein tumor thrombus. our previous showed that hepatic arterial infusion chemotherapy plus lenvatinib and toripalimab (programmed cell death protein-1 antibody) had a powerful anti-tumor effect for high-risk hepatocellular carcinoma, with a median overall survival of 18 months. thus, the purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin plus atezolizumab plus bevacizumab for patients with high-risk hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage c * high risk disease: vp-4 based on the japanese standard, bile duct invasion, or tumor occupancy ≥50% of the liver * eastern cooperative oncology group performance status of 0 to 2 * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment. * the following laboratory parameters: hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: high-risk hepatocellular carcinoma hepatic arterial infusion chemotherapy oxaliplatin, 5-fluorouracil and leucovorin atezolizumab plus bevacizumab
the use of tranexamic acid (txa) intravenously, to reduce blood loss in proximal femur surgery

Conditions: Femur Surgery

Summary: the use of tranexamic acid (txa) intravenously, to reduce blood loss in proximal femur surgery.


Eligibility criteria:
inclusion criteria: * patients over 60, who came to the orthopedic department for proximal femur fracture surgery * sound judgment exclusion criteria: * known hypersensitivity to tranexamic acid or component solution provided * subarachnoid hemorrhage * acquired color blindness * myocardial infarction in 12 months before admission * unstable angina * known clotting disorders (thromboembolic disease in the past, elongated pt and ptt, hypercoagulability), * kidney or liver failure * another situation prostate resection , pathologic fractures according to anamnesis or by imaging * oncology patients * patients on anticoagulation * patients undergoing vascular intervention ( coronary or peripheral ), which was inserted supporter requires a dual antiplatelet therapy
enhancing early-phase care for primary care patients with unhealthy substance use

Conditions: Substance Use Disorders

Summary: the clinical trial portion of this study tests the hypothesis that contingency management-based incentives for primary care patients with substance use disorders to attend treatment services will increase treatment initiation and engagement. the investigators are investigating whether this approach that has been found effective in specialty treatment settings will work in the primary care context, in conjunction with screening.


Eligibility criteria:
inclusion criteria: * positive self-report alcohol or drug use screen in primary care * diagnosis of substance use disorder * age 18 or older exclusion criteria: * sud treatment in past 60 days * cognitive impairment

Keywords: substance use disorders substance abuse substance abuse treatment contingency management
impact of threatened preterm labour in fetal cardiovascular and metabolic programming (shs)

Conditions: Obstetric Labor, Premature

Summary: the goal of this observational study is to learn about cardiac function and remodelling and metabolomic profiles in fetuses and infants who were exposed to a threatened preterm labor (tpl) during pregnancy.

the main questions it aims to answer are: * evaluate the impact of threated preterm labour in cardiovascular and metabolic programming in fetal life and early infancy. * describe prenatal and postnatal patterns of cardiac remodelling associated to threatened preterm labour. * describe fetal growth patterns associated to threatened preterm labour. * describe metabolomic profiles in umbilical cord blood associated to cardiovascular programming in fetuses exposed to threatened preterm labour. the study's main tasks are: * to perform an antenatal echocardiography of the exposed cohort is performed during the admission due to tpl or preterm spontaneous rupture of membranes (srm). * all participants are asked to fill a diet and stress questionnaire. * to collect cord blood at the time of delivery. * to perform a postnatal echocardiography six months after birth. researchers will compare fetuses and infants who were exposed to tpl to those who were not exposed to tpl during pregnancy to see if threre are any differences in cardiac function and remodelling.

Eligibility criteria:
inclusion criteria: * singleton pregnancies. * study patients must be 18 years or older * good understanding of spanish exclusion criteria: * multiple pregnancies * major fetal defects or anomalies * underlying process that can cause a preterm labour * iatrogenic preterm labour

Keywords: threatened preterm labor prematurity cardiac remodelling cardiac function
real-world evidence and treatment patterns: head and neck cancer

Conditions: Head & Neck Cancer

Summary: this study will be focused on hnc patients who have been diagnosed with hnc between 01-jan-2013 and 30-sep-2016.


Eligibility criteria:
inclusion criteria: * hnc or undefined histology (not otherwise specified \[nos\]) hnc diagnosis from 01-jan-2013 to 30-sep-2016 using japanese disease code * age 18 years or older at initial diagnosis of hnc regardless of staging exclusion criteria: * diagnosis of another malignancy on or before the initial diagnosis of hnc with the exception of non-melanoma skin cancer and metastatic cancer * diagnosis of hnc before 01-jan 2013 or after 30-sep-2016
bioequivalence and effect of food and water on lamotrigine in healthy volunteers

Conditions: Mental Disorders

Summary: this study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers


Eligibility criteria:
inclusion criteria: * healthy male or female subjects aged 19 to 55 years inclusive * bmi within the range 19 to 32 kg/m2 inclusive. exclusion criteria: * female subjects of childbearing potential will not be eligible if they are unwilling or unable to use an appropriate method of contraception at least 30 days prior to the first study drug through 30 days. * female subject is pregnant or lactating. * female subjects using hormonal contraceptive precautions including progesterone-coated intra-uterine device (iud). * female subjects using hormonal replacement therapy. * history of regular alcohol consumption \> 7 drinks week for women and 14 drinks week for men * current smokers of 10 or more cigarettes per day

Keywords: food effect safety tolerability water effect bioequivalence
comparison of brain perfusion in rhythm control and rate control of persistent atrial fibrillation

Conditions: Persistent Atrial Fibrillation

Summary: atrial fibrillation (af) is associated with impaired cognitive function (cogf) and/or dementia, but it is unclear whether rhythm control of af improves cogf or brain perfusion. the hypothesis is rhythm control of af improves cogf by increasing brain perfusion with hemodynamic amelioration compared to af state. we will randomize the patients with persistent af to rhythm control group and rate control group, and check baseline and 3rd month cognitive function (k-moca score) and brain perfusion ct. k-moca score and brain perfusion ct findings will be compared between rhythm control group and rate control group of persistent af.


Eligibility criteria:
inclusion criteria: * patients with persistent atrial fibrillation (20\~80 years old) * la diameter \< 55mm * patients possible to anticoagulation and anti arrhythmic drug exclusion criteria: * structural cardiac disease * contraindication to brain perfusion ct * catheter ablation history for af, cardiac surgery * active internal bleeding * impossible to anticoagulation or antiarrhythmic drug * valvular af ((ma\> gii, mechanical valve, mitral valve replacement) * lvef \< 30% * with severe medical disease * expected survival \< 1 year * severe alcoholics, drug addiction
effect of epidural analgesia on regional lung ventilation in parturient women as assessed by thoracic impedance

Conditions: Pregnancy Complications; Atelectasis

Summary: the goal of this observational study is to learn more about the effect of obstetric epidural anesthesia on regional lung ventilation in healthy parturient women. the main question it aims to answer is whether the initiation or epidural analgesia improves or not regional lung ventilation in healthy women at term during labor. participants will be subject to measurements of pulmonary impedance by electric impedance tomography before and after the start of epidural analgesia. no change will be applied to clinical care as a result of this measurement.


Eligibility criteria:
inclusion criteria: * at-term pregnancy (at least 36 weeks) * asa class i-ii exclusion criteria: * american society of anesthesiologists (asa) class iii or more * bmi\>35 before pregnancy * contraindication to routinely administrated drugs (levobupivacaine, lidocaine, sufentanil) * contraindication to epidural analgesia * pregnancy-related complications (including pre-eclampsia) * respiratory system diseases * severe psychiatric disorders * twin pregnancy * skin lesions in correspondence to the position of the electric impedance tomography belt * pacemaker or implantable cardioverter defibrillator (icd) * language barrier

Keywords: pregnancy labor at term electric impedance tomography pulmonary impedance
ultrasound measure of gastric volume in diabetic and non diabetic patients before general anesthesia

Conditions: Diabetes

Summary: the main objective is to compare the frequency of a " full stomach " in diabetic patients compared with a control population, all the patients having followed the instructions of preoperative fast.


Eligibility criteria:
inclusion criteria: * patients aged over 18 * american society of anesthesiologists (asa) classification 1 to 3 * needed a general anesthesia for a programmed surgical intervention * respect of instructions of the pre-operative fasting; * affiliation to the social security; * consent form signed non inclusion criteria: * pregnant or breastfeeding women * patients already operated or to be operated from the upper digestive tract (esophagus, stomach, duodenum) * patients treated with a prokinetic treatment and / or a level 3 analgesic exclusion criteria * unfeasibility to ultrasound measurement of antral area * failure to observe fasting instructions

Keywords: gastric contents ultrasound diabetes
intraoperative radiation therapy for resectable pancreatic cancer

Conditions: Resectable Pancreatic Adenocarcinoma

Summary: this phase ii study is designed to investigate the efficacy of iort for patients with resectable pancreatic adenocarcinoma. the purpose of the study is to show the local recurrence rate after surgical resection and iort is superior to that of surgical resection alone from the historical control. a total of 42 patients will be enrolled, and these patients will receive iort of 10 gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.

treatment outcomes of pancreatic cancer are poor even after surgical resection, thus patients may receive adjuvant chemotherapy or chemoradiotherapy. intraoperative radiotherapy (iort) with low energy (50 kv) x-ray allows delivery of a high dose radiation to the tumor bed during surgery while effectively sparing adjacent critical organs. another advantage of iort is that delivery of iort does not interfere with the scheduled administration of adjuvant chemotherapy or chemoradiotherapy. here we investigate the efficacy of iort for patients with resectable pancreatic adenocarcinoma by comparing the local recurrence rate after surical resection and iort with that of surgical resection alone from the historical control. a total of 42 patients will be enrolled in this phase ii trial, and these patients will receive iort of 10 gy at 5 millimeter depth of the tumor bed, followed by 6 cycles of adjuvant gemcitabine chemotherapy.

Eligibility criteria:
inclusion criteria: * 1. pathologically confirmed pancreatic adenocarcinoma 2. age ≥20 years 3. performance status ecog 0-2 4. patients must have resectable disease. in order to be resectable the following criteria must be met: * absence of distant metastases * clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery * absence of direct involvement of inferior vena cava or aorta * stage i-iii disease per ajcc 7th edition 5. laboratory data obtained ≤14 days prior to registration on study, with adequate bone marrow and renal function defined as follows: * hemoglobin \>10 g/dl, absolute neutrophil count (anc) \>1,500/mm3, platelets \>100,000/mm3 * serum cr \<1.4 mg/dl, bun \<20 mg/dl 6. ability to understand and the willingness to sign a written informed consent exclusion criteria: * 1. patients who have received external beam radiotherapy in the abdominal area 2. defined treatment area which cannot be adequately covered by the radiation field as defined by the radiation oncology treatment team 3. patients who have received neoadjuvant chemotherapy 4. stage iv disease 5. patients with distant metastases 6. current pregnancy or currently nursing
treatment for depressed, obese individuals at risk for cardiovascular disease (cvd)

Conditions: Obesity; Major Depressive Disorder; Dysthymic Disorder; Cardiovascular Disease

Summary: to determine whether individuals who suffer from depression and obesity are able to lose weight and show improvements in mood and cardiovascular disease risk factors following 20 weeks of a combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss. participants will be assigned to one of three treatments: 1) cognitive-behavior therapy for the treatment of depression combined with an alternative approach to weight loss, 2) a weight loss intervention combined with a depression support and education , or 3) cognitive-behavioral therapy for depression combined with a weight loss intervention.


Eligibility criteria:
inclusion criteria * female and male participants, with a bmi of 27 kg/m2 to 45 kg/m2 * age 18 - 70 years old * presence of current major depressive disorder or dysthymic disorder * at least 2 cvd risk factors, as characterized by the metabolic syndrome, including: * elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm) * fasting blood glucose 100 mg/dl * blood pressure 130/85 mm hg * triglycerides 150 mg/dl * reduced hdl cholesterol (males 40 mg/dl; females 50 mg/dl) * or medications for these conditions * able to comply will all study procedures and schedule * able to speak and read english exclusion criteria * cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months * use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (note: participants who take ssri/snri may be acceptable, provided they have been on a stable dose of these medications 3 months.) * use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months * weight loss of 5% or more in past 6 months * enrollment in weight reduction program in prior 3 months * treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (note: participants in couples or family counseling will be allowed.) * severe depression or severe impairment of functioning as judged by the assessor or pi * presence of active suicidal ideation * diabetes * alcohol/drug abuse/dependence * renal/hepatic disease * change in thyroid medications in last 3 months * pregnant/lactating, within 6-months post-partum * current diagnoses, or history within the last 5 years, of anorexia or bulimia * psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months * mood disorder nos, substance-induced mood disorders, mood disorders due to a general medical condition * history of bipolar disorder * history of head trauma * any changes in smoking behavior in prior 3 months (or plans to change in the next 3 months) * plans for bariatric surgery * any other uncontrolled major medical problems * women who are pregnant

Keywords: depression and obesity treatment
montelukast in pediatric allergic asthma (0476-336)(completed)

Conditions: Asthma

Summary: this is a 3-week study to evaluate fev1 following treatment with drugs in persistent asthma which is also active during allergy seasons in pediatric patients with seasonal aeroallergen sensitivity.


Eligibility criteria:
inclusion criteria: * male and female patients, ages 6 to 14 years, with persistent asthma that is also active during allergy season * patients must demonstrate positive skin prick tests to seasonally relevant geographic aeroallergens exclusion criteria: * patient cannot have any other acute or chronic pulmonary disorder