Kornimate/medical-research-clean huggingface dataset:
study of gl701 in men with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: lupus flares and other symptoms associated with systemic lupus erythematosus (sle) may be caused by a deficiency of dehydroepiandrosterone (dhea). gl701 is an investigational new drug meant to enhance dhea levels. this study is designed to evaluate both the safety and efficacy of gl701 in male lupus patients.


Eligibility criteria:
inclusion criteria * patient must have a diagnosis of sle \> 6 months according to the 1989 revised acr criteria. patient must meet at least four of the eleven acr criteria for systemic lupus * patient must have a modified sledai score \> 3 at both screening and qualifying visits (appendix a-2) * patient must be treated for sle with doses of prednisone \ 6 weeks prior to study entry (including both screening and qualifying visits). prednisone dose in patient's receiving alternate day therapy will be the mean daily prednisone dose * patient treated with azathioprine, methotrexate, or hydrochloroquine must be on a stable dose with no change in dose for at least 6 weeks preceding the study * patient must be able to read and speak english and willing to sign an informed consent in english exclusion criteria * patient with a history of prostate cancer * patient with elevated prostate specific antigen (psa) * patient diagnosed with liver disease, defined as ast or alt \> 3x the upper limit of normal * patient ingesting body building/anabolic steroids within the last 6 months preceding the study * patient with end stage renal disease or receiving hemodialysis treatment * patient with serum creatinine \> 2 mg/dl or creatinine clearance \< 60 ml/min * patient receiving treatment with acth within the 3 months preceding study entry * patient receiving androgens, immunoglobulins, cyclophosphamide, cyclosporin a, or other immunosuppressive agents, except azathioprine, methotrexate, and hydrochloroquine within the last 3 months * patient with known hypersensitivity to dhea or the inactive ingredients used in the gl70l formulation (cornstarch, lactose, and magnesium stearate) * patient who participated in any prior dhea study or administration of dhea within the past 3 months * patient using any investigational agents within the longer of 30 days or 10 half-lives of the agent * patient with any condition which in the investigator's or sponsor's opinion is sufficient to prevent adequate compliance with the study or likely to confuse follow-up evaluation (e.g.. alcoholism, drug addiction, acute withdrawal from chemical dependency, psychiatric disease) * patient requires treatment/medication prohibited by protocol * patient with any serious ekg abnormality as determined by the investigator

Keywords: lupus sle dhea gl701
the fibrin pad cv phase iii study

Conditions: Cardiovascular Disease

Summary: the objective of this study is to evaluate the safety and effectiveness of the evarrest™ fibrin sealant patch as an adjunct to hemostasis during cardiovascular surgery.


Eligibility criteria:
inclusion criteria: * subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass. subjects in japan between ≥18 and \<20 years of age will require consent by the subject's legal representative * subjects must be willing to participate in the study and provide written informed consent. * presence of an appropriate target bleeding site (tbs) along the anastomotic suture line, involving a synthetic aortic graft, as identified intra-operatively by the investigator; exclusion criteria: * subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products; * exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 60 day follow up period after surgery. * female subjects who are pregnant or nursing. * tbs is from a large defects in visible arteries or veins where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of evarrest™ fibrin sealant patch to blood flow and/or pressure during absorption of the product; * tbs with major arterial bleeding requiring suture or mechanical ligation; * tbs involves an expanded polytetrafluoroethylene (eptfe) graft * tbs within an actively infected field; * bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; * subjects with any intra-operative findings identified by the investigator that may preclude conduct of the study procedure;

Keywords: cardiovascular diseases fibrin sealant hemostatics coagulants
epigenetics based diagnosis of diabetes in saliva and blood samples

Conditions: Prediabetic State; Diabetes Mellitus, Type 2; Ectopic Lipids; Epigenetics Based Modifications

Summary: the aim of the present study is to investigate epigenetics based modifications and biomarkers in the saliva and blood in diabetic patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients * prediabetic patients * women with gestational diabetes * healthy control subjects without diabetes * healthy pregnant women exclusion criteria: * cancer disease * infectious diseases such as hepatitis or hiv * malignoms * patients with claustrophoby
the effect of video and traditional laryngoscopy on hemodynamic response in hypertensive and normotensive patients

Conditions: Intubation; Anesthesia; Hypertension

Summary: during endotracheal intubation, it is known that la laryngoscopy has significant effects, such as tachycardia and blood pressure increase, which may be harmful, especially in those with cardiovascular disease. different studies comparing laryngeal stimulation and there resulting hemodynamic response made with various intubation devices are available in the literature. the investigators planned to work with the hypothesis that endotracheal intubation with videolaryngoscopy would have less hemodynamic response traditional (macintosh) laryngoscopy and the use of videolaryngoscopy would result in wider vision with less laryngeal stimulation.

in this study, in a study on endotracheal intubation under general anesthesia, a routine preparation of endotracheal intubation using video laryngoscopy or macintosh laryngoscopy in adult hypertensive and normotensive patients between 18-75 years old, form will be written and recorded. patient age, weight, height, sex, operation, co-morbid conditions and vital findings, measurements used in airway evaluation, initial trial success, laryngoscope using number of procedures, intubation tube number will be recorded. statistical analysis was performed using statistical program to compare the hemodynamic response of hypertensive and normotensive patients using videolaryngoscope or macintosh laryngoscope

Eligibility criteria:
inclusion criteria: * age: 18-75 years. * underwent surgery under general anesthesia. exclusion criteria: * asa (american society of anesthesiologists) iv, v patients * preoperative systolic blood pressure 180 mmhg, diastolic blood pressure a pressure above 110 mmhg. * ejection fraction is less than 40%. * difficult intubation history * mallampati 3,4

Keywords: laryngoscopy videolaryngoscopy hypertension
opioid-induced bowel dysfunction pivotal assessment of lubiprostone

Conditions: Opioid-Induced Bowel Dysfunction

Summary: the primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (obd).


Eligibility criteria:
inclusion criteria: * consistent treatment for chronic, non-cancer-related pain with any full agonist opioid for at least 30 days prior to screening. * diagnosis of opioid-induced bowel dysfunction as confirmed during the screening period. * if patient has a history of chronic constipation, condition must have been exacerbated by initiation of opioid treatment. * use of prescribed or over-the-counter (otc) medication that affects gastrointestinal motility (other than opioid therapy) must be discontinued during the study. * if treated for clinical depression with selective serotonin reuptake inhibitors (ssris), serotonin-norepinephrine reuptake inhibitors (snris), or monoamine oxidase (mao) inhibitors, treatment must have been at a stable dose for at least 30 days prior to screening. * use of laxative and stool softeners (with the exception of approved rescue medications) must be discontinued while on study. exclusion criteria: * opioid dose adjustment (+/- 30%), and/or change in opioid agent or route of administration within 30 days of screening. * non-ambulatory patients, or those who are unable to eat/drink, take oral medications, or to hold down oral medications due to vomiting. * treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction. * patient has been treated for cancer in the past 5 years (with the exception of localized basal cell, squamous cell skin cancer, or in situ cancer that has been resected). * gastrointestinal or abdominal surgical procedures within 90 days prior to screening. * female patients of childbearing potential who are unable/unwilling to use protocol-specified method(s) of birth control and/or are pregnant, nursing, or plan to become pregnant or nurse during the study.
dalteparin vs unfractionated heparin for the prevention of venous thromboembolism (vte) in hospitalized acutely ill medical patients

Conditions: Venous Thromboembolism

Summary: the purpose of this study is to compare the efficacy and safety of dalteparin vs unfractionated heparin for the prevention of vte (venous thromboembolism) in hospitalized acutely ill medical patients.

the study was prematurely discontinued due to delay in overall study start-up and inability to meet pre-defined protocol recruitment milestones on june 30th, 2008. there were no safety concerns regarding the study in the decision to terminate the trial.

Eligibility criteria:
inclusion criteria: * aged greater than or equal to 18 years * acute medical condition with a projected hospitalization of greater than or equal to 4 days and had less than or equal to 3 days of prior immobilization for more than two thirds of the day * acute congestive heart failure class iii-iv per nhya/ acute respiratory failure not requiring mechanical ventilation or both * acute infection without septic shock/ acute episode of inflammatory bowel disease/ acute rheumatologic disorders/ acute lumbar pain or sciatica or vertebral compression with at least one risk factor for vte exclusion criteria: * contraindications to use of anticoagulants * active bleeding or abnormal coagulation tests * recent (less than 1 month) head injury, hemorrhagic stroke, cerebral tumor or intracranial aneurysm or ischemic stroke within the last month. * major surgical or invasive procedure within the last month resulting in ongoing convalescence * lumbar or spinal puncture within last 48 hours * s creatinine levels more than 2 * on inotropic agents

Keywords: hospitalised acutely medically ill patients; venous thromboembolism, infection, inflammatory bowel diseases, heart failure, congestive, sciatica
clinical trial of the impact of treatment consultation recordings on cancer patient outcomes

Conditions: Brain Tumor; Neuroendocrine Cancer

Summary: the time period from diagnosis through to the end of treatment is challenging for patients. patients need information, assistance with decision making, and emotional and social support to help cope with their diagnosis and treatment. the first meeting with the cancer doctor is especially anxiety-provoking for patients who will learn, for the first time, their treatment options and likelihood of being cured. this anxiety causes many patients to have difficulty remembering the important pieces of information that their cancer doctor tells them during this consultation. the main goal of this study is to demonstrate the benefits of giving cancer patients an audio-recording of their first consultation with their cancer doctor. the investigators will include newly diagnosed patients from cancer centres in winnipeg and calgary. the types of cancer that will be included in this study are brain and neuroendocrine. patients with these types of cancer are more likely to have confused thinking, and therefore may have the most to gain from receiving their consultation recordings. the study will include 244 patients, and those who sign consent forms to participate will be assigned by chance to either receive their treatment consultation recording or not. patients will receive their recording immediately after their consultation, and will be able to listen to the recording at any time either alone, or with family and friends. to figure out whether the consultation recording provides patients with benefits, the investigators will administer some questionnaires to patients at 1 week after the consultation, and again at 3 and 6 months after the consultation. these questionnaires will assess the following patient outcomes: i) anxiety and depression, ii) perception of being informed about the disease and treatment, iii) satisfaction with cancer care, iv) satisfaction with the doctor, and v) the extent to which patients are satisfied with their degree of involvement in treatment decision making. the investigators hypothesize that patients who receive their consultation recording will experience more benefits than patients who do not receive their consultation recording.


Eligibility criteria:
inclusion criteria: * presenting with a primary diagnosis of non-recurrent or metastatic brain, or neuroendocrine cancer * 18 years of age or older * able to read and communicate using the english language * access to a computer to enable consultation playback exclusion criteria: * deemed by a treating clinician (or primary nurse for the treating clinician) to have any severe psychiatric condition or cognitive dysfunction that precludes provision of free and informed consent to participate

Keywords: consultation recording brain tumor neuroendocrine cancer quality of life patient satisfaction
mechanical bone stimulation and adenosine 5'-triphosphate (atp) release in humans

Conditions: Osteoporosis

Summary: rationale: mechanical loading is well-known to have a strong anabolic effect on bone. it has therefore been proposed that a mechanical intervention could be an effective non-pharmacological approach to treat bone loss associated with conditions such as osteopenia and osteoporosis. data from in vitro experiments indicate that the purine nucleotide adenosine 5'-triphosphate (atp) is released by bone cells and mediates cellular crosstalk via p2 purinergic receptors in response to mechanical stimulation. atp release by bone cells may thus be part of a general mechanism by which mechanical loading ultimately results in increased bone formation, but this remains to be investigated in humans in vivo. the investigators hypothesize that a mechanical intervention in humans leads to a rise in systemic atp concentrations due to atp release from bone. objective: to investigate in vivo whether a measurable increase in systemic atp levels occurs in response to mechanical stimulation of bone in humans. study design: intervention study with a non-randomized, non-blinded design. all subjects will participate in a single experiment, lasting approximately 3 hours, during which the subjects will receive a mechanical intervention at a fixed dose. study population: maximally 10 healthy human volunteers (18-35 y). intervention: subjects will receive a gentle and safe mechanical intervention, which will be administered by means of a juvent 1000 vibration platform delivering low-magnitude mechanical stimuli (i.e. vibrations) to the forearm. the mechanical stimulation will be administered at a frequency of 90 hz and amplitude of 10 µm in an intermittent fashion, i.e. three 10-minute periods of stimulation with 10-minute rest periods in between. main outcome parameters: as the primary outcome parameter, a change in extracellular atp concentrations as a result of the mechanical intervention will be assessed systemically.


Eligibility criteria:
inclusion criteria: * healthy human volunteers; * age 18-35 years; * cannulation of veins in forearm possible; * written informed consent. exclusion criteria: * metabolic bone disease (osteoporosis, paget's disease, hyperparathyroidism, osteomalacia) or any other condition affecting bone metabolism (e.g. corticoid-treated rheumatoid arthritis); * recent bone fracture of any kind ≤ 12 months preceding the study; * blood donors.

Keywords: mechanical stimulation vibration platform bone metabolism atp release
a study of patient-reported outcomes in patients with lung or esophageal cancer

Conditions: Lung Cancer; Esophageal Cancer

Summary: this survey study is looking to determine if patient reported outcomes(using the promis survey) will vary according to the presence of recurrent or metastatic lung or esophageal cancer.

a patient-centered approach to lung cancer surveillance following resection needs to incorporate patient reported outcomes. the patient reported outcomes measurement information system (promis®) was designed to revolutionize the assessment of patient reported outcomes by establishing a national resource for the measurement of patient-reported symptoms and other health outcomes. the promis assessment center, the management tool within the larger promis system, will be used to securely store de identified data, provide automated accrual reports and data export for this specific study. this study will have it's own study specific website. patients seen at the university of virginia cancer center will be identified and invited to participate in an assessment of their reported outcomes over multiple domains available in promis. collecting this information on lung cancer survivors may provide a robust platform to design a patient-centered surveillance strategy following resection. the study team hypothesizes that patient reported outcomes will vary according to the presence of recurrence or metastasis of lung or esophageal cancer. the study team also believes including patient reported outcomes into routine post-treatment surveillance will improve patient satisfaction and improve outcomes.

Eligibility criteria:
inclusion criteria: * ≥18 years of age * suspected or known diagnosis of lung or esophageal cancer * willing and able to complete questionnaires exclusion criteria: * subjects unwilling to provide informed consent * subjects unwilling or unable to answer the questionnaires

Keywords: lung cancer esophageal cancer
evaluation of cognitive management for chemobrain in patients treated for breast cancer.

Conditions: Breast Cancer

Summary: this project will investigate the efficacy of a cognitive remediation programme in patients treated for breast cancer. patients will be randomized between "no intervention" and "intervention programme". efficay will be assessed in term of improved quality of life.

medical progress in the treatment of cancer has prolonged patients' life expectancy. this improvement has led researchers to become concerned about the long-term negative effects of cancer treatments on quality-of-life. in particular, previous studies have identified complaints that have been submitted concerning the cognitive status of patients treated with chemotherapy (berglund et coll., 1991). all of these cognitive changes are collectively grouped under the term chemobrain. the consequences of treatments remain however underestimated, as the priority when diagnosing cancer remains the patient's short- to medium-term survival; yet, quality-of-life contributes to the long-term survival of patients (kramer, 2000). in addition to medical treatments, psychosocial care adapted to the specific needs of subjects is thus important for improving their quality-of-life and helping them return to work. even if initiatives have multiplied over the past few decades in the psychosocial management of these subjects (e.g., supportive care), that related to cognitive disorders in subjects having survived cancer remains a little documented field. cognitive deficiency in cancer survivors is said to be moderate (razaq et coll., 2017), which makes survivors ideal candidates for cognitive rehabilitation.

Eligibility criteria:
inclusion criteria: 1. women aged 20 to 60 years inclusive. 2. localised breast cancer having required neoadjuvant or adjuvant chemotherapy, the last cycle of which took place between 2 and 24 months prior to inclusion. 3. informed consent dated and signed. 4. patient with french social security cover in accordance with french law on biomedical research (article 1121-11 of the french code of public health). exclusion criteria: 1. metastatic breast cancer. 2. presence of unstable psychiatric or neurological disorders likely to affect cognition (information requested directly from the participant) 3. history of drug abuse. 4. patient who cannot read or understand french. 5. patient already included in this study. 6. patient having participated in oncogite workshops. 7. patient participating in another clinical trial evaluating cognitive remediation. 8. patient deprived of freedom or subject to legal protection measures (under guardianship, in custody of the court, or family-member guardianship order).

Keywords: cognition
study of the safety and immune response of a meningococcal vaccine administered to healthy children

Conditions: Prevention of Meningococcal Disease

Summary: the purpose of this study is to evaluate the safety and immunogenicity of novartis (formerly chiron) meningococcal acwy conjugate vaccine administered to healthy children ages 1 - 10 years


Eligibility criteria:
inclusion criteria: * group 1: healthy children 2-10 years of age; * group 2: healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis b, hemophilus influenzae type b, and pneumococcus. exclusion criteria: * group 1: subjects with a previous or suspected disease caused by n. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); any serious acute, chronic or progressive disease. * group 2: subjects with a previous or suspected disease caused by n. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); any serious acute, chronic or progressive disease.
endocuff vision colonoscopy vs. amplifeye colonoscopy

Conditions: Colorectal Adenoma; Colorectal Polyp; Colorectal Cancer

Summary: the study aims to compare the results between colonoscopies with two different attachments on the distal end of the colonoscope.

this will be a prospective, randomized controlled study. subjects referred for a screening, surveillance, or diagnostic colonoscopy will be prospectively enrolled. this study aims to compare the number of adenomas detected per colonoscopy (apc) between an endocuff colonoscopy and an amplifeye colonoscopy. it is estimated that the endocuff vision will result in an apc of 2.3. the investigators consider that a clinically acceptable adr for the medivators device would be within 20% of this value or 1.5.

Eligibility criteria:
inclusion criteria: * 40 years of age or older * undergoing colonoscopy for screening, surveillance, or diagnostic purposes * able to provide written informed consent exclusion criteria: * active inflammatory bowel disease * prior resection of the colon * referred for resection of a polyp identified by another physician * referred for a previous incomplete colonoscopy

Keywords: colonoscopy