Kornimate/medical-research-clean huggingface dataset:
study of oxaliplatin, irinotecan, and s-1 in biliary tract cancer

Conditions: Biliary Tract Neoplasm

Summary: this study will conduct a phase ii study of triple combination with oxaliplatin, irinotecan, and s-1 as the first-line chemotherapy in patients with advanced biliary tract cancer.

it is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic biliary tract cancer is better than that compared to best supportive care. in general, gemcitabine based combination chemotherapies are considered as the first line treatment for patients with advanced biliary tract cancer, but these have some limitations of inconvenience of administration and unsatisfactory efficacy. s-1 monotherapy and combination with oxaliplatin have shown the objective response rate of 21-35% and 24.5%, respectively, and irinotecan combined with oxaliplatin has shown the response rate of 18-20.5% in patients with advanced metastatic biliary tract cancer. so the investigators had conducted the phase i study of three drugs (oxaliplatin, irinotecan, and s-1) with modification of dosage and schedule and will conduct a phase ii study with recommended dose of triple chemotherapy from this phase i study.

Eligibility criteria:
inclusion criteria: * pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of biliary tract system (stage iv by primary tumor, regional nodes, metastasis(tnm) staging system) * eastern cooperative oncology group (ecog) performance status 0-2 * more than 3 months expected life span * measurable lesion by recist criteria version 1.1 * palliative chemotherapy naive * adequate organ functions * participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital exclusion criteria: * any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer. * participants who had received radiation therapy for target lesions 4 weeks before study enrollment * participants who had received major surgery 4 weeks before study enrollment * participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding * participants with central nervous system(cns) metastases * participants with peripheral sensory neuropathies with impaired functional activities * participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.

Keywords: biliary tract neoplasm oxaliplatin irinotecan s-1
intellectual impairment in women with breast cancer

Conditions: Breast Cancer

Summary: rationale: breast cancer and its treatment may cause changes in a patient's ability to think, learn, and remember. gathering information about a woman's genes, brain function, and personal history may help doctors learn more about the disease and plan the best treatment. purpose: 1. to determine changes in brain function that occur following breast cancer chemotherapy. 2. to gain further understanding of the individual differences in brain function changes and recovery based on demographic, medical and treatment variables.

this study aims to determine some of the genetic, neurobiologic and demographic factors that are associated with cognitive outcome following breast cancer (bc). additionally, it aims to test novel behavioral interventions designed to improve executive function skills following bc treatment.

Eligibility criteria:
inclusion criteria: 3.1.1 primary, non-metastatic breast cancer 3.1.2 newly diagnosed patients who have not yet begun treatment. 3.1.4 female participants age 40-65 years of all ethnicities who speak fluent english will be recruited. 3.1.5 there are no life expectancy restrictions. 3.1.6 karnofsky performance status 70% minimum. ecog will not be employed. 3.1.7 there are no requirements for marrow function. the brain must be free from gross neuropathology and metastases in order to participate. 3.1.8 ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 3.2.1 history of cognitive, psychiatric or medical conditions prior or unrelated to cancer diagnosis and/or known to significantly impact assessments (e.g. premature birth, developmental delays, learning disabilities, severe psychiatric conditions, brain injury, stroke). non-english speaking. major sensory impairment (e.g. hearing loss, blindness) that would render assessments invalid. mri contraindications (e.g. metallic implants or devices). distant metastases. see also section 4.2.1. 3.2.2 participants currently involved in studies specifically aimed at improving cognitive symptoms will be excluded. 3.2.3 participants with significant co-morbid diseases known to significant impact neuropsychological function such as alzheimer's or parkinson's will be excluded. 3.2.4 there are no known risks for allergic reactions to any of the study procedures. 3.2.5 participants taking certain medications that affect neuropsychological and/or brain function including haldol, aricept, ritalin, etc. will be excluded. most anti-depressants are acceptable. some anti-anxiety medications may not be. each case will be individually reviewed. 3.2.6 there are no other agent-specific exclusion criteria. 3.2.7 pregnant individuals will be excluded as this is a contraindication for the 3 tesla research mri scanner employed by this study but not because of the treatment programs per se. nursing individuals can enroll. 3.2.8 patients who are hiv positive will be excluded given the known effects of this condition on cognitive function which would confound the effects of anti-cancer treatments on cognitive outcome.

Keywords: quality of life
physiology & optical coherence in stemi

Conditions: Myocardial Infarction

Summary: the objective of this study is to prospectively evaluate the outcomes of different treatment pathways using a physiology \& imaging guided pci in patients with stmei. a multi-centre study that will prospectively enrol consecutive stemi patients who don't receive primary pci within 48 hours after symptom onset because of different reasons. stemi patients with culprit lesion stenosis between 0%-90% will be included in this study and randomized to angiography-guided, ffr-guided or oct guided pci groups.


Eligibility criteria:
inclusion criteria: - age ≥18 years stemi for 7-30 days have not undergone pci because: stabilization in a non-pci hospital followed by transfer to a tertiary hospital for further evaluation;previous emergent angio without ballooning or stenting;previous emergent thrombus aspiration without ballooning or stenting;pharmacoinvasive therapy stenosis between 0%-90% timi flow grad 3 exclusion criteria: - left main disease or bypass disease intolerance to a study drug, metal alloys, or contrast media life expectancy less than one year previous pci or cabg history cardiogenic shock or lvef\ 90% stenosis in culprit lesion timi flow ≤ grade 2 planned surgery within 6 months after index procedure clinical indications of inability to tolerate dapt for 12 months inability to provide written informed consent participation in another trial before reaching the primary endpoint
impact of sleep education program on glycemic control in hong kong chinese type 2 diabetic patients

Conditions: Type 2 Diabetes Mellitus

Summary: this is a randomized controlled trial with 12 month sleep education as intervention, followed by a 12 month observational period, to study whether sleep education would improve glycemic control and cardiometabolic profile of sleep deprived type 2 diabetic patients and evaluate the neurohormonal changes associated with sleep education.

patients will be identified from the diabetes mellitus and endocrine centre of prince of wales hospital and yao chung kit diabetes assessment centre, the chinese university of hong kong. all participants will have diabetes complications screening and comphrensive evaluations for glycemic control and cardiometabolic risk factors.eligible subjects will be randomized to 2 groups (usual or conventional care versus intervention with sleep education program) for 12 months.

Eligibility criteria:
inclusion criteria: 1. aged 18-65 years 2. type 2 diabetes mellitus 3. chinese ethnicity 4. able and willing to give informed written consent 5. sleep deprived, defined as subjective sleeping time \<6 hours per day exclusion criteria: 1. type 1 diabetes mellitus 2. known history of psychiatric disorders (e.g. depression, anxiety, dementia) 3. sleep disorders secondary to another medical condition (e.g. obstructive sleep apnoea (osa), circadian rhythm sleep disorder) 4. concomitant chronic medical condition that was likely to be the cause of sleep problem (e.g. benign prostatic hypertrophy, chronic pain) 5. concurrent use of hypnotic drugs, psychotic medications and any drugs that are known to affect sleep. 6. any condition, as judged by the investigators, as ineligible to participate in this study
effect of motor cognitive interference on cognition and quality of life on patients with multiple sclerosis

Conditions: Multiple Sclerosis, MS

Summary: is there an effect of cognitive motor interference on cognition and quality of life on multiple sclerosis patients.

we will assess the effectiveness of cognitive motor interference on cognition and quality of life on multiple sclerosis patients

Eligibility criteria:
inclusion criteria: 1. m s patients complain of mild cognitive impairment according to modified mini mental state (mmse). 2. patients with remission and relapse, primary and secondary progression types of ms. 3. age between 25 and 45 years. 4. patients from both gender. exclusion criteria: 1. patients have visual disorders 2. patients have auditory disturbance 3. non educational patients. 4. patients with psychiatric disorders. 5. patients with mod to severe cognitive impairment according to mmse

Keywords: multiple sclerosis ms cognition cognitive motor interference quality of life qol
achilles tendon rupture, comparison two different operative techniques. prospective randomized controlled trial. 14 years follow-up.

Conditions: Achilles Tendon Rupture

Summary: the intention is to compare 60 patients with achilles tendon rupture, who where randomized in 1998-2001 preoperatively to receive end-to-end suturation by the krackow locking loop technique either without augmentation or with one central down-turned gastrocnemius fascia flap (silfverskjöld). postoperative care was identical for both groups; a brace allowed free active plantar flexion of the ankle postoperatively, whereas dorsiflexion was restricted to neutral for the first three weeks. weight bearing was limited for six weeks. to compare these treatments, we use 1998 published leppilahti-score, rand-36 quality of life-questionnaire and mri. mean follow-up time is 14 years. hypothesis; augmentation with a down-turned gastrocnemius fascia flap does not provide better result than would end-to-end suture repair with use of the krackow locking loop surgical technique in long-term follow up.


Eligibility criteria:
inclusion criteria: * total achilles tendon rupture diagnose. exclusion criteria: * more than 7 days old rupture, local corticosteroids injection in around the achilles tendon, rupture was open/ there where skin problems over achilles tendon area, patient lived abroad, if the main author was unavailable, or patient refused to participate.

Keywords: achilles tendon rupture, operative treatment, elongation, long-term follow up.
the utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment

Conditions: Atopic Dermatitis; Eczema

Summary: the utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

the study consists of 9 visits. duplimab will used in the treatment of adult onset atopic dermatitis. qualified subjects will receive 5 dupilumab open-label injections. skin biopsies/ skin strips will be obtained at the beginning and the end of treatment. tarc and ige levels will be obtained at the beginning and end of treatment. subjects will complete daily diaries assessing atopic dermatitis symptoms. patient reported out comes will be completed at each visit

Eligibility criteria:
inclusion criteria: * history of adult onset atopic dermatitis exclusion criteria: -
remote ischemic preconditioning prior to vascular surgery

Conditions: Peripheral Arterial Disease; Vascular Surgery

Summary: the investigators have previously shown that elective vascular surgery is a high-risk operation with an anticipated risk of either death or heart attack of 15%. this study is testing whether a protocol of remote ischemic preconditioning (ripc) applied 24 hours prior to the operation is safe, feasible and reduces the incidence of an adverse, perioperative cardiac complication.

the proposed investigation has a single blind, randomized design and plans to enroll 180-205 patients who are scheduled to have major, elective vascular surgery for occlusive carotid disease, expanding abdominal aortic aneurysm (aaa), occlusive lower extremity disease and/or critical limb ischemia at the minneapolis va health care center. 24 hours prior to the patient's scheduled vascular operation, ripc therapy will be applied to one of the participant's upper arms to cause forearm ischemia. clinically collected, pre-operative troponins, creatine kinase mbs (ck-mbs), ekgs along with troponins, ck-mbs and ekgs collected on day 1, 2, 3 and day 7 (if still hospitalized) will be utilized to evaluate the occurrence of perioperative, adverse cardiac events.

Eligibility criteria:
inclusion criteria: * undergoing elective major vascular surgery at the minneapolis va medical center for abdominal aortic aneurysm, carotid disease or limb ischemia. * age \> 18. * provides informed consent. exclusion criteria: * hypertensive crisis * peripheral arterial disease of the upper extremities * arteriovenous (av) fistula * acute coronary syndrome (acs) in the last 6 months * severe valvular heart disease * pregnant women * unable to provide consent
use of azithromycin as immunomodulatory therapy in grave&apos;s orbitopathy

Conditions: Graves Ophthalmopathy

Summary: the purpose of this study is to examine the effects of azithromycin (a macrolide class antibiotic), given three times weekly, for patients with active moderate-severe, non sight-threatening, graves orbitopathy. indices for follow-up will include: * clinical activity score * anti-tsh receptor antibody levels * thickening of extraocular muscles per ultrasound * quality of life score for graves orbitopathy patients

graves orbitopathy (go) is an autoimmune inflammatory disorder causing visual morbidity, cosmetic morbidity and interference with quality of life. the disease has an inflammatory stage and a non-inflammatory, fibrotic stage. treatment of inflammatory stage moderate-severe go includes steroids, as recommended by the eugogo consortium. however, the length of treatment needed and the risk of steroid side-effects may lead to multiple undesired treatment induced morbidity. antibiotics of the macrolide group posses known immune-modulatory effects that are separate from their antibacterial mode of action. this mode of action has lead to the routine use of macrolide antibiotics for delaying graft rejection following lung transplants. we propose to test the effect of this class of antibiotics for non-sight threatening, moderate-severe, inflammatory go.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of graves orbitopathy * clinical activity score higher than 2 * must be able to swallow tablets exclusion criteria: * sight-threatening graves orbitopathy * diplopia in primary gaze * macrolide allergy or intolerance

Keywords: graves orbitopathy macrolide antibiotics inflammation clinical activity score
closure of patent ductus arteriosus with the amplatzer duct occluder the amplatzer® duct occluder

Conditions: Patent Ductus Arteriosus (PDA)

Summary: aga-004 - the objective of the study is to determine safety, effectiveness and clinical utility of the amplatzer duct occluder in patients with patent ductus arteriosus. aga-007 - the objective of this study is to evaluate the long term safety and effectiveness issues that may not have have been adequately addressed during aga-004.


Eligibility criteria:
inclusion criteria: * patients with a demonstrated patent ductus arteriosus * body weight \> 5 kilograms exclusion criteria: * pulmonary vascular resistance above 8 woods units or a rp/rs \>0.4. * additional cardiac or non-cardiac abnormality that can reasonably be expected to significantly affect the patient's health adversely in the next two years, i.e.: cancer, eisenmenger's syndrome, other serious congenital heart disease. * pelvic vein or inferior vena cava thrombosis * sepsis (local/generalized) or any type of infection that cannot be successfully treated prior to device placement. * history of repeated pulmonary infection * demonstrated intracardiac thrombi on echocardiography • inability to obtain informed consent

Keywords: patent ductus arteriosus (pda)
effectiveness of taping on anastomotic regions in patients with breast cancer-related lymphoedema

Conditions: Breast Cancer Lymphedema; Compression Bandages; Manual Lymphatic Drainage

Summary: one of the most common conservative treatments of lymphoedema is complex decongestive physiotherapy (cdp). the bandage is one of the most important components of the treatment process. the multilayer short-stretch bandage is used to maintain volume reduction and prevent lymph backflow caused by compression. however, some patients refuse or postpone treatment or show a lower compliance with compression bandaging.kinesio® tex tape (kt) is a new technique for managing lymphoedema in the field of physical and alternative therapy, and it may affect decongestion of lymphatic fluid accumulated under the skin. some studies which showed that kt was an effective for patients with bcrl, it was applied on both the affected arm and anastomosis. one of these studies also reported that a significant reduction in limb volume in patients who were applied of the tape only to the affected arm. this significant effect could also be seen by applying kt only to the anastomosis. in literature, however, there is no evidence to support this theory. so the aim of this study is to determine the effectiveness of kt which was applied to anastomotic regions along with cdp in the management of bcrl.


Eligibility criteria:
inclusion criteria: * patients who had unilateral bcrl and women aged over 18 who were 'significant', 'marked', or 'severe' lymphoedema. exclusion criteria: * patients with paralysis on part of the affected arm, * patients who had undergone cdp more than once within six months, * patients who had an active infection, * patients who had a skin disease.
to study different levels of mk0493 for safety, efficacy, and tolerability in obese patients (0493-017)(completed)

Conditions: Obesity

Summary: to study different doses of mk0493 for safety, efficacy and tolerability in obese patients.


Eligibility criteria:
inclusion criteria: * patient is between 21 and 65 years of age exclusion criteria: * hiv positive as determined by medical history * patient is pregnant, lactating or plans to become pregnant * patient has undergone surgical treatment for obesity * patient has undergone a surgical procedure within 4 weeks prior to visit 1 or plans to undergo a surgical procedure during the study * patient plans to consume more than 2 glasses of grapefruit juice per day during the study * patient has participated in another clinical study (involving an investigational drug) within 3 months prior to restudy screening
the next generation longitudinal birth cohort diabetes study

Conditions: Type 2 Diabetes; Gestational Diabetes Mellitus

Summary: the overall aim of this project is to understand the independent roles of maternal factors, intrauterine exposures, genetic factors, and postnatal environment on the development of obesity and youth-onset type 2 diabetes (t2d) in childhood.

our primary objective for the study is to clinically and metabolically phenotype parents and their offspring to identify risk factors for obesity, t2d, and cardiometabolic risk in childhood and adolescence in a prospective birth cohort by reporting: 1. maternal and/or paternal factors including anthropometrics, metabolic parameters, hnf1a genotype, lifestyle (diet and physical activity), and socioeconomic environment. 2. infant factors including anthropometrics, early infant nutrition, and metabolism. secondary objectives: 1. to evaluate if children born to mothers with t2d prior o pregnancy are at increased risk of obesity and t2d. 2. to determine the modifiable risk factors which contribute to the increased risk of obesity and t2d. 3. to evaluate the differential risk between mothers and fathers with t2d in terms of somatic and genetic contributions to risk compared to intrauterine environmental contributions to risk. 4. to plan a large-scale, randomized, controlled community-based breastfeeding intervention with intensive breastfeeding counseling and support for the prevention of t2d development in offspring of mothers or fathers with youth onset t2d. 5. to explore potential new research questions and feasibility studies for epigenetic studies using cord blood under the umbrella of the new research theme on t2d at the children's hospital research institute of manitoba.

Eligibility criteria:
inclusion criteria: * pregnant women with type 2 diabetes, gestational diabetes, or no diabetes. * from self-identified indigenous heritage (e.g., cree, oji-cree, métis, anishinaabe, etc.). * are delivering and residing in manitoba. * mother/father and children must be biological family members. exclusion criteria: * mothers or children with type 1 diabetes. * residing outside of manitoba.
group training for parents whose children suffer from adhd and comorbidity using a behavioral-dynamic approach

Conditions: ADHD

Summary: the purpose of this study is to determine whether a new parent training protocol for children with attention deficit hyperactivity disorder (adhd) can over perform the state of the art parent training protocol (pbt) by increasing the long term effectiveness of the treatment, reducing the dropout rate and reducing the comorbidities.


Eligibility criteria:
inclusion criteria: * parents to children 6-12 with adhd symptoms according to the criteria of diagnostic and statistical manual of mental disorders - 5th edition (dsm-v) * the child was diagnosed in the past as adhd by md exclusion criteria: * parents with psychotic symptoms or suicidality * parents with active manic episode * parents with substance dependence * parents with autism spectrum disorder

Keywords: adhd