Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula

Conditions: Thrombosis

Summary: many guidelines at home and abroad advocate that arteriovenous fistula should be the first choice of permanent vascular access, but it is easy to form thrombus in a short time after arteriovenous fistula molding, resulting in internal fistula stenosis or occlusion. in this study, the investigators plan to screen the patients with arteriovenous fistula in the blood purification center of our hospital. through the study design of random grouping and open label, the investigators will discuss the use of low molecular weight heparin or warfarin to prevent thrombosis in a short period of time after arteriovenous fistula operation. according to the research results, the investigators will understand efficacy and safety of short-term postoperative anticoagulant therapy to prevente thrombosis in arterovenous fistula.


Eligibility criteria:
inclusion criteria: * after avf formation or balloon dilation surgery, there were no significant signs of oozing or bleeding at the surgical incision and operative site observed within 12-24 hours. * the patient is willing to accept short-term anticoagulant therapy after the surgery, bear related risks, and sign an informed consent form. * the patient is willing to cooperate with this study, undergo data collection related to the research, and relevant clinical examinations. exclusion criteria. * age \>80 years; * concurrent hematologic diseases that can affect coagulation function; * concurrent comorbidities that can affect the patient's bleeding or coagulation functions, such as liver cirrhosis; * concurrent active bleeding disorders, such as active gastrointestinal ulcers or active lupus; * history of major organ bleeding (e.g., intracranial or gastrointestinal) or surgery within the past six months; * unwillingness to participate in this study.

Keywords: manitenance hemodialysis arteriovenous fistula anticoagulant therapy fistula function bleeding risk
resistance exercise training at different intensities in healthy and frail older people: a feasibility study

Conditions: Frail Elderly Syndrome

Summary: after the age of 40-45 years muscle mass and function progressively decline, reducing older peoples' abilities to perform tasks of daily living and also increase the risk of falls. it is known that, across the life course, resistance exercise can be of benefit in increasing muscle mass and function, yet how hard the exercise should be performed has received little attention. current recommendations are for older people to perform exercise at 70% of the maximum they can lift, quite a high intensity that often puts older people off participating. recent evidence in younger people has suggested that such intensities are not required. the investigators aim to determine the feasibility of a study to investigate recruitment and adherence of older people to a study of exercise training at different intensities.

the cohort will comprise two sets of participants: frail older adults and non-frail older adults. each participant will receive 8 weeks of twice weekly supervised resistance training. both the frail and non-frail participants will be randomised into either receiving high load resistance training or low load resistance training. high load resistance training will be delivered at 70% of the participants maximal capacity and low load resistance training will be delivered at 30% of maximal capacity. all resistance training will focus on the lower limb and regardless of intensity each exercise will be done to failure (unable to complete another full repetition).

Eligibility criteria:
inclusion criteria: non-frail - over 65 years of age frail - over 65 years of age, three or more of the following criteria: \>10lbs of weight loss unintentionally in previous year; grip strength in lowest 20% (by sex and bmi); self-reported exhaustion; walking time for 15 feet in slowest 20% (by sex and height); physical activity in the lowest 20%. exclusion criteria: non-frail - current participation in an exercise programme. clinical team do not think resistance exercise would be safe or unable to consent. any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in geriatric medicine where required. frail - current participation in an exercise programme. clinical team do not think resistance exercise would be safe or unable to consent. any other reason that precludes participation in exercise, decision made by research team in consultation with a consultant in geriatric medicine where required.

Keywords: frailty exercise resistance training strength older adults
improving cardio-metabolic and mental health in women with gestational diabetes mellitus and their offspring

Conditions: Gestational Diabetes Mellitus

Summary: mysweetheart trial is a randomized controlled trial to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve the cardio-metabolic and mental health of women with gdm and their offspring. primary objective of mysweetheart trial: to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention in women with gdm to improve 1) their metabolic health (decrease in maternal weight between study inclusion after gdm diagnosis and at 1 yr postpartum) and 2) their mental health (decrease in maternal symptoms of depression during the same time period). secondary objective of mysweetheart trial: to test the effect of a multidimensional interdisciplinary lifestyle and psychosocial intervention to improve other cardio-metabolic and mental health markers in women with gdm and their offspring. mysweetheart trial is linked to mysweetheart cohort, an observational cohort study that assesses the effect of gdm on offspring cardiovascular health early in life. the principal investigators of the cohort are nicole sekarski and arnaud chiolero (university hospital lausanne, switzerland). their primary objective is to assess the effect of gdm on the surrogate markers of cardiovascular disease (cvd) at birth (left ventricular mass index and subclinical atherosclerosis) and the secondary objective is to assess the effect of gdm on the cardiovascular structure and function during the fetal period and neonatal adverse cardiovascular risk factors.


Eligibility criteria:
inclusion criteria: * women and their partners aged 18 yrs or older, with gdm at 24-32 weeks of gestation, and understanding french or english. exclusion criteria: * women on strict bed-rest, with pre-existing diabetes or known severe mental disorder.

Keywords: gestational diabetes mellitus randomized controlled trial lifestyle intervention cardiovascular metabolic mental health depression physical activity dietary intervention
prognostic value of 18fdg pet/ct textural indices in hnscc

Conditions: Cancer of Head and Neck

Summary: head and neck (hn) cancer is the sixth most common malignancy worldwide, with around 800,000 new cases and 320,000 deaths in 2015. these malignancies encompass cancers of the oral cavity, oropharynx, hypopharynx and larynx and concerned squamous cell carcinomas (scc) 90% of the time. despite aggressive treatment strategies, the five-year survival rate has only marginally improved in the past decade especially because of a high rate (up to 40%) of loco-regional recurrence. moreover, two-third of local relapse and lymph node metastases occur in the first 2 years after treatment. hence, predicting tumor response to therapy remains a real challenge in head and neck cancers. usual prognostic factors include the tumor size, the lymph node involvement, the presence of distant metastasis, the anatomic subsite, and the human papilloma virus (hpv 16, 18) infection status. however, pre-treatment selection of patients with poor prognosis or who require intensified therapy remains difficult despite their careful evaluation. hnscc also present a high biologic heterogeneity with hypoxic area, necrotic regions, zones of high cellular proliferation and intra-tumoral angiogenic heterogeneity. a better characterization of tumor heterogeneity could help classify patients in different risk subgroups in order to improve their therapeutic management. pre-therapeutic 18f-fluorodeoxyglucose positron-emission tomography (fdg pet/ct) is recommended by guidelines to assess remote extension of locally advanced hnscc and/or to look for synchronous cancer. its prognostic significance has already been suggested and a selection of patients at risk of recurrence appears possible using different quantitative parameters. indeed, static (suv = standardized uptake value), volumetric (mtv = metabolic tumor volume, tlg = total lesion glycolysis) and kinetic (ri = retention index) parameters were demonstrated to be independent prognostic factors in several studies. texture analysis is currently highly studied in order to characterize tumor heterogeneity, and consists in extracting texture indices from different imaging modalities such as fdg pet/ct. calculating texture indices relies on choosing a contouring method to delineate a tumor volume of interest and selecting several parameters such as the resampling method, matrix definitions and indices formula. several studies conducted on small series of patients with hnscc have showed promising results to predict survival, analyzing various cancer anatomic subsites, tumor segmentation methods and texture indices. the objective of this study is to assess the prognostic value of texture indices in a large cohort of patients with hsncc, including any anatomic subtype and staging.


Eligibility criteria:
inclusion criteria: * biopsy proven hsncc * written consent exclusion criteria: * previous head and neck malignancy

Keywords: squamous cell carcinoma fdg pet/ct textural analysis
panomic approach to immune-connected assays in small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the scope of the picasso project is to apply an innovative patient-based pan-omic approach to immune-assays, that will include multi-omics tumour characterization (genome, proteome, transcriptome), blood immune-cells and cytokine profiling, serological screening for paraneoplastic autoantibodies, clinical and metabolic measurements. the picasso project is aimed to validate in real world population the predictive role of sclc transcriptomic classification (particularly, i-sclc subtype) and to explore correlations with dynamic changes in peripheral blood immunity. additionally, investigators expected to validate the predictive/prognostic role of emerging new variables, including metabolic-induced meta-inflammation alterations and subclinical auto-immunity.


Eligibility criteria:
inclusion criteria: 1. histologically- or cytologically-documented extensive-stage sclc 2. to have received upfront treatment with cisplatin/carboplatin, etoposide and anti pd1/pd-l1 inhibitors 3. no evidence of brain metastases at diagnosis 4. ecog ps 0-2 5. adult patients (aged ≥ 18 years) at diagnosis; 6. signing of informed consent approved by the local ethic committee exclusion criteria: * none

Keywords: sclc immunotherapy
the neurobiology of depressive illness

Conditions: Major Depression

Summary: we aim to determine why patients with depression are at an elevated risk for the development of coronary heart disease, and resolve whether the severity of a patient's depression has a counterpart in demonstrable abnormalities in brain chemistry. studies will be completed in 28 patients with depression; both males and females. patients will be studied both untreated and during administration of a selective serotonin re-uptake inhibitor (ssri) antidepressant. they will be either newly diagnosed with depression, untreated patients suffering a recent relapse, or patients seeking to switch from a non-ssri antidepressant due to non-response. the turnover of chemical messengers in the brain will be estimated by high internal jugular venous blood sampling and dna will be isolated and examined from blood cells. immune function will also be assessed. whole body and cardiac sympathetic nervous activity will be determined, as well as microneurographic recording of muscle sympathetic nervous activity. it is hypothesised that patients with depression and no existing demonstrable cardiac disease demonstrate: alterations in brain monoaminergic neurotransmitter turnover, resulting in sympathetic nervous activation and dysregulation of the baroreflex control to both the heart (vagal) and muscle vasoconstrictor sympathetic nerves; and exhibit enhanced platelet reactivity predisposing them to thrombogenesis and myocardial ischaemia. therapeutic intervention with an ssri will modify cardiac sympathetic function, baroreflex sensitivity or platelet reactivity in a fashion likely to reduce cardiac risk.


Eligibility criteria:
inclusion criteria: * major depression exclusion criteria: * heart disease diabetes hypertension psychosis significant suicidal risk dementia

Keywords: major depression cardiac disease
evaluation of the dose received by the prostate with in vivo dosimetry in patients treated with daily igrt associated with imrt using two repositioning techniques for localized prostate cancer

Conditions: Prostate Cancer

Summary: this study evaluates the dose received by the prostate with in vivo dosimetry when delivering image guided radiation therapy (igrt) associated with intensity modulated radiation therapy (imrt) for patients with localized prostate cancer using two repositioning techniques: fiduciary markers or soft tissues.

10 participants will receive a cone beam computed tomography (cbct) repositioning, while the other 10 will receive a kv imaging of fiducial marker repositioning. the principal objective is to evaluate and compare the dose received by the prostate using two repositioning techniques.

Eligibility criteria:
inclusion criteria: * male \> 18 years * carcinoma of the prostate histologically confirmed * oms 0-1 * localized stage * favorable, intermediate and unfavorable groups according to nccn or d'amico classification * patients must have signed a written informed consent form * patients must be affiliated to a social health insurance. exclusion criteria: * metastasis * indication for pelvic radiation * anticoagulant therapy * lateral or bilateral hip replacement * patient receiving an adult protective services * patient unable to comply with the required medical follow-up for geographic, social or psychological reasons

Keywords: raypilot dosimetry cbct (cone beam computed tomography)
combination of radiation therapy and anti-pd-1 antibody in treating patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the objective of this study is to evaluate the efficacy and safety of radiation therapy combined with anti-pd-1 antibody in patients with pancreatic cancer


Eligibility criteria:
inclusion criteria: 1. age:18-75 years, male or female. 2. histologically or cytologically confirmed pancreatic cancer. 3. measurable disease based on response evaluation criteria in solid tumors (recist) 1.1. 4. can provide either a newly obtained or archival tumor tissue sample. 5. ecog 0-1. 6. life expectancy of greater than 12 weeks. 7. adequate organ function. 8. patient has given written informed consent. exclusion criteria: 1. patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. 2. other malignancy within 5 years prior to entry into the study, expect for curatively treated basal cell and squamous cell carcinoma of the skin and/or curatively resected in-situ cervical and/or breast cancers. 3. known central nervous system (cns) metastases. 4. subjects with any active autoimmune disease or history of autoimmune disease. 5. uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> nyha ii congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 6. active infection or an unexplained fever \> 38.5°c during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); 7. history of interstitial pneumonia or active non-infectious pneumonitis. 8. known human immunodeficiency virus (hiv) infection、active hepatitis b or hepatitis c. 9. prior therapy with a pd-1, anti-pd-ligand 1 (pd-l1) agent. 10. concurrent medical condition requiring the use of cortisol (\>10mg/day prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. except: inhalation or topical corticosteroids. doses \> 10 mg/day prednisone or equivalent for replacement therapy. 11. has received prior anti-cancer monoclonal antibody (mab), chemotherapy, targeted small molecule therapy, or radiation therapy within 4 weeks prior to study day 1 or not recovered from adverse events due to a previously administered agent. 12. received a live vaccine within 4 weeks of the first dose of study medication. 13. pregnancy or breast feeding. decision of unsuitableness by principal investigator or physician-in-charge.

Keywords: pancreatic cancer radiation anti-pd-1 antibody
non-interventional substudy of alx-hpp-502 to assess natural history of patients with juvenile-onset hpp who served as historical controls in enb-006-09

Conditions: Hypophosphatasia; Bone Disease

Summary: the purpose of this study is to characterize the natural history of hpp in patients with juvenile-onset hpp who served as historical controls in enb-006-09.

hypophosphatasia (hpp) is a life-threatening, genetic, and ultra-rare metabolic disease characterized by defective bone mineralization and impaired phosphate and calcium regulation that can lead to progressive damage to multiple vital organs, including destruction and deformity of bones, profound muscle weakness, seizures, impaired renal function, and respiratory failure. there are no approved disease-modifying treatments for patients with this disease. there is also limited data available on the natural course of this disease over time, particularly in patients with the juvenile-onset form.

Eligibility criteria:
inclusion criteria: * documented informed consent/assent prior to video collection and data abstraction. * documented informed consent/assent in study alx-hpp-502. * patients with juvenile-onset hpp and was selected as a historical-control for study enb-006-09. * patients with at least 2 videos of basic mobility that were recorded at 2 different clinic visits when the patient was ≥5 to ≤15 ye exclusion criteria: * there are no exclusion criteria for this study

Keywords: hpp soft bones low alkaline phosphatase genetic metabolic disorder alkaline phosphatase tissue non-specific alkaline phosphatase rickets osteomalacia
gemcitabine as a single agent in the maintenance chemotherapy of patients with metastatic breast cancer

Conditions: Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer; Gemcitabine; Maintenance Chemotherapy

Summary: the primary purpose of our study is to evaluate whether gemcitabine as a single agent is superior to observation in improving progression-free survival (pfs) in patients with metastatic breast cancer (mbc) who achieved disease control with an initial six cycles of pg as their first-line treatment


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic, or recurrent breast cancer * age over 18 years * ecog performance status 0-2 * premenopausal or postmenopausal breast cancer patients with measurable or non-measurable lesions, who are candidates for chemotherapy * life expectancy ≥ 3 months * patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it has been 12 months since completion of regimen. * patients either may or may not have a prior anthracycline containing regimen. * prior hormonal therapy as a treatment of metastatic disease is allowed. but antitumoral hormonal therapy must be terminated prior to enrollment(up to the date of randomization) * prior radiation therapy allowed as long as \< 25% of the bone marrow has been treated,and the patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed 4 weeks before study entry. * adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul, ≥ hemoglobin 9.0 g/dl) * adequate renal function (≤ serum creatinine 1.5 mg/dl or ccr ≥ 50 ml/min) * adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ ast/alt x 3 upper normal limit) * no prior history of chemotherapy for metastatic, recurrent breast cancer * written informed consent exclusion criteria: * serious uncontrolled intercurrent infections * serious intercurrent medical or psychiatric illness, including active cardiac disease * pregnancy or breast feeding * second primary malignancy(except cancer of cervix or skin or other malignancy treated at least 5 years previously with no evidence of recurrence) * documented parenchymal or leptomeningeal brain metastasis * peripheral neuropathy ≥ grade 2 * prior treatment with gemcitabine will not be allowed. * her-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed
electroacupuncture analgesia for colonoscopy

Conditions: Pain

Summary: background: colonoscopy is often regarded as a painful and unpleasant procedure. electroacupuncture (ea) has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy. objective: to investigate the efficacy of ea in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy. design: prospective, randomized, double-blind, sham-controlled study. subjects: one hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture will be recruited. interventions: patients will be randomized to receive either 45 minutes of ea or sham acupuncture (sa) before colonoscopy. the acupoints relevant to the treatment of abdominal pain, including zusanli, hegu, and neiguan will be used. for the sa group, blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. foam blocks will be used to stabilize the needles and to blind the patients and endoscopists to the treatment allocation. ea and sa will be continued throughout colonoscopy. a mixture of propofol and alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups. outcome measures: primary outcome: doses of patient-controlled sedation/analgesia consumed. secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.


Eligibility criteria:
inclusion criteria: * consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy * patients with american society of anesthesiologists (asa) grading i-ii * informed consent available exclusion criteria: * patients with previous experience of acupuncture * patients with previous history of colorectal surgery * patients who are diagnosed with irritable bowel syndrome according to rome iii criteria * patients with chronic pain syndrome * patients with psychiatric disorder * patients with poor cognitive function * patients with renal impairment * patients with obstructive sleep apnea syndrome * patients with cardiac arrhythmias * patients with cardiac pacemaker * patients who are pregnant * patients who are allergic to the acupuncture needles or propofol/alfentanil