Kornimate/medical-research-clean huggingface dataset:
a study of chemoradiotherapy using gem plus nab-paclitaxel for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the clinical safety and efficacy of gemcitabine plus nab-paclitaxel chemoradiotherapy and to determine the maximal tolerated dose (mtd) for unresectable locally advanced pancreatic adenocarcinoma.

gemcitabine plus nab-paclitaxel is one of the standard chemotherapy for metastatic pancreatic adenocarcinoma. gemcitabine plus nab-paclitaxel realize the favorable anti-tumor effect and tolerable toxicity. gemcitabine plus nab-paclitaxel is a promising regimen for concurrent chemoradiotherapy, but the investigators need to know the safety in the case of the concurrent chemoradiotherapy.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced pancreatic cancer * locally advanced pancreatic cancer is defined as the presence of a surgically unresectable tumor(involving the celiac axis or the superior mesenteric artery) * performance status:0-1(ecog) * patients of age =\>20 and 75\> * white blood cell (wbc) \>=3,500/mm3,12,000/mm3, * neutrophils \>=1,500/mm3, platelets=100,000/mm3, * hemoglobin \>=9.5 g/dl, * got \</=2.0 x upper limit number (uln), * glutamate pyruvate transaminase (gpt) \</=2.0 x uln, * alkaline phosphatase (alp) \</=2.0 x uln, * total bilirubin \<=1.5mg/dl, * serum creatinine \<=1.2mg/dl, * creatinine clearance\>=50 ml/min * arterial o2 pressure (pao2) \>=70torr or arterial o2 saturation (spo2) \>=96% * life expectancy more than 3 months. * written informed consent. exclusion criteria: * active infection * lung fibrosis or intestinal pneumonia detectable on chest x-ray and ct * severe complication (heart disease, cirrhosis, diabetes) * myocardial infarction within 3 months * active synchronous or metachronous malignancy * pregnant or lactation women, or women with known or suspected pregnancy * symptomatic brain metastasis * history of severe drug allergy * peripheral neuropathy * patients who are judged inappropriate for the entry into the study by the investigator
long term extension study for spm-005 participants

Conditions: Rheumatoid Arthritis

Summary: this will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (vns) device in patients with rheumatoid arthritis. patients who complete study spm-005 will be enrolled in this study at the time of the last visit of the preceding study.

this will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (vns) device in patients with rheumatoid arthritis. patients who complete study spm-005 will be enrolled in this study at the time of the last visit of the preceding study. the assessments at the last visit of the preceding study will also be used as baseline measures for the current study. if the patient has previously discontinued spm-005 and greater than 30 days have elapsed since the final visit in spm-005, baseline measures for the current study will be repeated, and an interim medical history will be taken to assess whether any new medical conditions were diagnosed in the time between studies. follow-up visits will occur at 3, 6, 12, 18, 24, 36 and 48 months. a final follow-up visit will occur for all remaining patients at study closure when the final enrolled subject has completed 48 months on study. the study will continue until the last patient entered has completed 48 months in this study. an interim visit or a phone contact must be performed a maximum of 2 months after any change in device settings. interim visits may also be performed at any time at the investigator's discretion; either between scheduled visits, or after the patient has completed the month 48 visit, if the study is still ongoing. the primary efficacy objective is to determine the long term efficacy of vagal nerve stimulation as assessed by the das28 score. the secondary efficacy objectives are to determine the long term efficacy of vagal nerve stimulation as assessed by: * the acr 20, 50 and 70 response rate, * the eular response rate, and * changes in the euro-qol score. the safety objectives are to determine the long term safely of vagal nerve stimulation as assessed by the subject incidence rates of: * adverse events * serious adverse events * device deficiencies

Eligibility criteria:
inclusion criteria: * patients must have participated in study spm-005 exclusion criteria: * inability to provide informed consent * significant psychiatric illness or substance abuse

Keywords: rheumatoid arthritis vagus nerve vagal nerve stimulation
a study to validate a pain diary for patient with trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the aim of the study is to establish the validity of a patient reported diary in tn . the following objectives have been identified: 1. to generate evidence to support diary content validity by performing qualitative research studies with tn patients and healthcare professionals (hcps). 2. to provide further support to the diary, sensitivity to change, known groups validity (ability to differentiate between severity groups), and construct validity.

this study will engage up to 20 participants with tn through patient associations or hcps. the study will be conducted in english speaking countries. the study comprises the following parts : * participants recruitment * completion of the diary * qualitative interviews with participants * analysis of qualitative research to assess content validity * secondary analysis as a workshop with a panel of experts to finalize the diary the diary will be provided to each participant and to hcps. participants will be requested to follow the instructions, use the diary and provide their feedback on the diary.

Eligibility criteria:
inclusion criteria: * male or female aged of 40 years or more. * must be able to read, write, and speak english to complete the consent process and participate in an interview. * able and willing to provide consent for participation in the study, and to allow the study team to access their data entries including audio or video recordings. - - participant with a current or previous diagnosis of tn * willing to participate in up to 30 minutes remote interviews or in-person interview (this interview will be recorded by the hcp) * committ to fill in the diary according to the hcp instruction exclusion criteria: * not applicable
ultrasound guided posterior versus lateral transversus abdominis plan block for prolonged postoperative analgesic effect in children

Conditions: Pain, Postoperative

Summary: ultrasound guided posterior versus lateral transversus abdominis plan block for prolonged postoperative analgesic effect in children

the investigators will compare the effect of posterior transversus abdominis plan block versus the effect of lateral transversus abdominis plan bock regarding the duration of analgesia and patients satisfaction the study will be conducted on 69 children aged from 1 to 7 years presented for lower abdominal surgery.

Eligibility criteria:
inclusion criteria: * children from 1- 7 years * scheduled to undergo lower abdominal surgery exclusion criteria: * bleeding disorders * emergency surgery * skin lesion at site of needle insertion
hfcwo in prolonged mechanical ventilation patients

Conditions: Chronic Ventilator Dependency

Summary: the effectiveness, safety and tolerance/comfort of high-frequency chest wall oscillation (hfcwo) in prolonged mechanical ventilation patients remain unknown. this study aimed to test the hypothesis that hfcwo could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest x-ray (cxr), and greater weaning success rates after extubation in prolonged mechanical ventilation (pmv) patients with intra-tracheal intubation.

for over 20 years, studies have attempted to examine the effectiveness, safety and tolerance/comfort of hfcwo in the management of surgical and non-surgical patients who had impaired bronchial secretion clearance, including those with neuromuscular disorders, chronic obstructive pulmonary disease, cystic fibrosis, and blunt thoracic trauma, or those hospitalized for critical cardiac/abdominal/thoracic surgery. however, these outcomes of hfcwo on pmv patients remain unknown. this parallel-design, randomized controlled trial aimed to test the hypothesis that hfcwo could produce greater clearance volume of sputum, greater improvement rates in serial changes in the chest x-ray (cxr), and greater weaning success rates after extubation in pmv patients with intra-tracheal intubation. moreover, the safety and tolerance/comfort of hfcwo in pmv patients after removal of endotracheal tubes were also evaluated.

Eligibility criteria:
inclusion criteria: 1. continuous intra-tracheal intubation and mechanical ventilator support for at least 21 days 2. age ≥20 year-old 3. having an acute or chronic pulmonary condition requiring secretion mobilization as judged by the physician 4. alert consciousness; completion of the modified borg scale (mbs) and hamilton anxiety scale (has) 5. scheduled extubation within 24 hours after enrollment 6. without any contraindication for hfcwo (i.e., recent spinal injuries which have not yet been stabilized and active hemorrhage with hemodynamic instability) exclusion criteria: 1. those who had undergone tracheostomy

Keywords: effectiveness elderly high frequency chest wall oscillation mechanical ventilation pneumonia randomized controlled trial
lifestyle intervention for polycystic ovary syndrome: pulse-based diet and exercise

Conditions: Polycystic Ovary Syndrome; Metabolic Syndrome

Summary: the purpose of our study is to evaluate the effectiveness of a lifestyle program for women with polycystic ovary syndrome (pcos). the investigators want to assess the effect of a pulse-based diet (i.e. a diet that contains lentils, chick-peas, peas, and beans) and aerobic exercise for improving pcos disease features and risk factors for metabolic syndrome. we would like to determine the therapeutic effects of a lifestyle program that combines a pulse-based diet and exercise on the multiple disease measures of pcos and metabolic syndrome.

to date, we have developed the pulse-based and meat-based healthy meals following therapeutic lifestyle changes (tlc)guidelines recommended by ncep for the intervention. we have been recruiting and enrolling participants into the study with our few set of participants having completed the 4 month intervention. baseline data have been also collected on all participants assessed for pcos. preliminary measurements on pocs characteristics, baseline dietary and exercise habits of women with pcos will be soon available. this study involves an intervention comparing a diet containing pulses (i.e. beans, peas, chick peas, lentils) to a diet recommended by the national cholesterol education program (ncep) for improving markers of metabolic syndrome and fertility in women with poly cystic ovarian syndrome who are also enrolled in an aerobic exercise program. to date, seven women in the pulse-diet group have completed the intervention, nine women in the group receiving the ncep diet have completed the intervention, four women are currently enrolled on the pulse diet and two women are currently enrolled on the ncep diet.

Eligibility criteria:
inclusion criteria: * female * diagnosis of pcos * aged 18-35 years exclusion criteria: * taking birth control or fertility medications * medical conditions that limit exercise or which limit consumption of a pulse-based diet (allergies or intolerances)

Keywords: polycystic ovary syndrome metabolic syndrome pulse lifestyle intervention aerobic exercise diet
a study of ly2127399 in participants with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus; Connective Tissue Disease; Autoimmune Disease

Summary: the purpose of this sle study is to evaluate the efficacy, safety and tolerability of two different doses of ly2127399 administered in addition to standard of care therapy in participants with active sle.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of sle as defined by american college of rheumatology (acr) criteria * have positive antinuclear antibodies (ana) * agree not to become pregnant throughout the course of the trial * have a screening selena-sledai score ≥6. (the participant must be actively exhibiting all the symptoms scored on the screening selena-sledai on the day of screening.) exclusion criteria: * have active severe lupus kidney disease * have active central nervous system or peripheral neurologic disease * have received intravenous immunoglobulin (ivig) within 180 days of randomization * have active or recent infection within 30 days of screening * have had a serious infection within 90 days of randomization * have evidence or test positive for hepatitis b * have hepatitis c * are human immunodeficiency virus (hiv) positive * have evidence of active or latent tuberculosis (tb) * presence of significant laboratory abnormalities at screening * have had a malignancy in the past 5 years, except for cervical carcinoma in-situ or basal cell or squamous epithelial skin cell that were completely resected with no reoccurrence in the 3 yrs prior to randomization * have received greater than 40 mgs of prednisone or equivalent in the past 30 days * have changed your dose of antimalarial drug in the past 30 days * have changed your dose of immunosuppressive drug in the past 90 days * have previously received rituximab

Keywords: sle systemic lupus erythematosis lupus autoimmune disease ly2127399 immune system disease
anti-platelet and statin therapy to prevent cancer-associated thrombosis

Conditions: Solid Tumor; Cancer

Summary: this research study examines the safety and feasibility of aspirin with or without simvastatin in solid tumor patients at risk for vte (venous thromboembolism - or blood clots - in the arms, lets, lungs, or other part of the body). one-fifth of all thrombotic (clotting) events occur in patients that have cancer. changes in sp-selectin will be used as a measure of efficacy. we have chosen sp-selectin as the primary marker because of its role in hemostasis, because it is predictive of thrombosis in cancer patients and because of promising preliminary data. we expect that sp-selectin levels will be elevated in patients before therapy with aspirin and/or statin, but that these levels will fall significantly during treatment, rise during the observation phase, and fall during the second study period. patients who take part in the study have been diagnosed with a solid tumor cancer and are considered to be intermediate to high risk for vte. the standard of care is to give chemotherapy for solid tumors and treat clots which develop using blood thinners.

objectives primary: to determine efficacy of aspirin with and without simvastatin in solid tumor patients at high- or intermediate-risk for vte, in reducing markers of platelet activation, levels of inflammatory and angiogenic cytokines measured using high-throughput approaches, and clinical and investigational measures of hemostatic activation. secondary: to determine safety and feasibility of aspirin with or without simvastatin in solid tumor patients at high- or intermediate-risk for vte

Eligibility criteria:
inclusion criteria: * histologic diagnosis of malignancy of a solid organ or lymphoma * planned to initiate a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen) * vte risk score ≥1 * written, informed consent. exclusion criteria: * hematologic malignancies including acute and chronic leukemias, myelodysplastic syndromes, lymphoma and myeloma * primary brain tumors * active bleeding or high risk of bleeding in the opinion of the investigator * hepatic dysfunction (elevated transaminases or bilirubin \> 3 times normal) * planned stem cell transplant * life expectancy \< 6 months * acute or chronic renal insufficiency with creatinine clearance \< 30 ml/min * pregnancy * known allergy to or prior intolerance of aspirin and/or simvastatin. * ongoing anticoagulant, statin and/or anti-platelet therapy.

Keywords: solid tumor, cancer, simvastatin, aspirin, blood clot, vte, venous thromboembolism
use of topical lidocaine to reduce pain in patients with diabetic neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: the purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.


Eligibility criteria:
inclusion criteria: * group 1: 18-70 years of age, non-diabetic with no nervous system disease (healthy control group) * group 2: 18-70 years of age with type i or type ii diabetes with significantly painful diabetic neuropathy (vas \> 40mm at baseline) * group 3: 18-70 years of age with type i or type ii diabetes with non- painful or insignificantly painful diabetic neuropathy (vas \< 40mm at baseline) exclusion criteria: * history of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator * allergy to lidocaine * unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study * women who are pregnant, breastfeeding or trying to become pregnant * history of slow-healing diabetic foot ulcers * current skin or soft tissue lesions on the foot that will interfere with application of the lidocaine patch and or skin biopsies * subjects taking class i antiarrhythmics * hga1c \> 11% * active cancer within the previous two years except treated basal cell carcinoma of the skin * co-morbidities that can produce neuropathy * subjects taking sodium channel blockers within one week of study treatment and throughout the study * subjects taking any other experimental drugs within 30 days prior to screening visit (visit 1) * application of lidocaine patch to either foot within two weeks of screening visit (visit 1)
efficacy of paper-based cognitive training in vietnamese patients with early alzheimer's disease

Conditions: Alzheimer Disease

Summary: the purpose of this study is to assess the efficacy of paper-based cognitive training in vietnamese patients with early alzheimer's disease


Eligibility criteria:
inclusion criteria: * for patient: * diagnosis of probable alzheimer's disease per dsm-5 criteria; * in the early stage of ad (mmse from 20 to 25); * age from 60 - 80 years old; * had greater than 5 years of formal education. * for caregiver: * members (including, but not limited to partners, children, relatives, lived-in helper of the patient) that are important for care delivery and provide care-related tasks (eg personal care, eating, cooking, cleaning) and everyday decision making to the patients. they are not required to live together or spend a specific amount of time with the patients; * older than 18 years of age; * possess adequate vietnamese language skills and no cognitive impairment to conduct interview and evaluation exclusion criteria: * for patient: * patients with concomitant diseases (heart failure, kidney failure, liver failure or thyroid diseases) that affect cognitive functions; * diagnosed with significant neurologic disease other than ad (parkinson's disease, multi-infarct dementia, schizophrenia, history of significant head trauma followed by persistent neurologic defaults, ...), major depression within the past 1 year, or taking psychoactive medications (antidepressants with significant anticholinergic side effects, neuroleptics, chronic anxiolytics or sedative hypnotics, etc) within the past 1 month; * having major visual, auditory, reading, or writing impairments; * patients and/or caregivers who decline to participate. * for cargiver: * having subjective complaints of cognitive impairment prevents them from understanding the instruction from the research team; * having significant visual, auditory, reading, or writing impairments; * caregivers who decline to participate

Keywords: early alzheimer disease paper - based cognitive training randomized trial
mitochondrial dna deletions in plasma as a diagnostic aid for females presenting with symptoms of endometriosis

Conditions: Endometriosis

Summary: this study will investigate the clinical performance and diagnostic accuracy of the mitomic® endometriosis test (met) compared to laparoscopic diagnosis in a prospective clinical study in females presenting with symptoms suggestive of endometriosis. this study will recruit patients with suspected endometriosis who have been referred for a diagnostic laparoscopy. patients will complete a questionnaire about their endometriosis symptoms and a sample of blood will be taken prior to their laparoscopy and sent to the laboratory for the met to be run. this study aims to first enroll 104 subjects to support the clinical validation necessary for launch of the test as an ldt. following this, we plan a study extension with an aim to enroll up to 900 more (for a total of 1000) subjects to enable more precise estimation of performance characteristics, characterization of test performance in subtypes of endometriosis, to better understand the relationship between test results and secondary endpoints such as symptoms and demographic variables, and to establish a bank of samples to support future test development.


Eligibility criteria:
inclusion criteria: 1. be female, between menarche and menopause who present with symptoms of endometriosis at time of blood collection and are scheduled to undergo their first laparoscopic procedure for the diagnosis of endometriosis 2. provide a blood sample prior to surgical procedure or administration of drugs related to the surgical procedure (i.e. anaesthetics, antibiotics) 3. be fit to undergo all procedures listed in protocol 4. be able to provide written informed consent exclusion criteria: 1. has had a prior surgical diagnosis of endometriosis at time of blood collection 2. is unable to communicate in written and spoken english 3. has any other condition, which in the opinion of the investigator, would make the subject not a suitable candidate for the study. this reason must be recorded on the crf