Kornimate/medical-research-clean huggingface dataset:
uark 2005-05, coagulation-related effects of velcade treatment in patients with relapsed or refractory multiple myeloma

Conditions: MULTIPLE MYELOMA

Summary: to evaluate changes in coagulation (blood clotting) factors and platelet function in multiple myeloma participants undergoing velcade treatment for the first time.

cardiovascular complications during the treatment of patients with multiple myeloma are not uncommon, (10%) and the frequency clearly increases with the use of regimens containing thalidomide in combination with glucocorticosteroids or chemotherapy especially adriamycin. even with prophylactic anticoagulation, dvt still occurs in 10% of such patients. the use of full anticoagulation raises considerable concern of bleeding especially during the post chemotherapy thrombocytopenic period. we observed no thromboembolic episodes when velcade was added to thalidomide and adriamycin containing chemotherapy. therefore, we would like to investigate this protective antithrombotic effect of velcade in a malignancy associated with a hypercoagulable state in a group of 10 patients with relapsed/refractory multiple myeloma.

Eligibility criteria:
inclusion criteria: * patients with myeloma who had relapsed after one prior treatment and who have demonstrated resistance to their last treatment, who are candidate to receive velcade and had normal pt and ptt, will be evaluated for inclusion in the present study. exclusion criteria: * previous history of venous thromboembolism, myocardial infarction, stroke, tia * hypercoagulable state (deficit atiii, factor v leiden, deficit protein s, deficit protein c, prothrombin gene mutation), antiphospholipid syndrome. * von willebrand disease, inherited platelet abnormalities. * familiar history of hypercoagulable state. * anticoagulant therapy, aspirin, non-steroidal anti-inflammatory drugs, beta blockers, tricyclic antidepressant, hormone replacement therapy, bcps, and all other agents able to interfere with platelet function in the previous two weeks. * non-secretory mm, unless the patient has measurable lesions on ct, mri and/or pet.

Keywords: plasmacytoma
study evaluating the combination of etanercept and methotrexate in rheumatoid arthritis subjects

Conditions: Rheumatoid Arthritis

Summary: this study is an open label extension of a previously completed double-blind, randomized study comparing etanercept and methotrexate in subjects with active rheumatoid arthritis. all subjects will receive combination treatment with etanercept and methotrexate.


Eligibility criteria:
inclusion criteria: * subjects who completed the previous double-blind,randomized study. * ability to reconstitute and self-inject test etanercept (etn) or have a designee who can do so. exclusion criteria: * dose of prednisone\>10 mg/day (or equivalent) or dose changed within 2 weeks before week 0 evaluation. * clinically relevant concurrent medical events including: uncompensated congestive heart failure (chf), diagnosis of multiple sclerosis or other central demyelinating diseases, presence or history of confirmed blood dyscrasias, cancer or history of cancer, serious infection within 1 month of test article administration or active infection at week 0.

Keywords: rheumatoid arthritis
eus-ppg vs hvpg in portal hypertension

Conditions: Cirrhosis; Portal Hypertension

Summary: the objective of this study is to evaluate the correlation of the calculated portal pressure gradient (ppg) obtained by direct portal and hepatic pressure measurements with a conventional 22 g needle guided by eus and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (hvpg) procedure.


Eligibility criteria:
inclusion criteria: * age above 18 years * undergoing evaluation for chronic liver disease or portal hypertension * signed informed consent exclusion criteria: * uncorrectable coagulopathy (inr above 1.5) * uncorrectable thrombocytopenia (platelets under 50,000) * anticoagulation or antiplatelet therapy that cannot be discontinued * biliary obstruction * grade ii ascites or more * intrahepatic portal vein thrombosis * pregnancy

Keywords: eus endoscopic ultrasound portal hypertension portal pressure gradient hepatic venous pressure gradient
evaluation of interest chemo-oncogramme in patients with colonic adenocarcinoma stage 4

Conditions: Colon Cancer

Summary: in patients with colonic adenocarcinoma stage 4 which are potentially resectable metastases (lung and liver metastases), treatment with chemotherapy is necessary but not end in success in 10% of cases. the development of techniques for administering personalized treatment becomes necessary for these patients. thus, in vitro tests on cells from tumors of these patients and evaluating the effect of chemotherapy on these could be made for each patient. in france, the company develops oncomedics these tests. this is a pilot study that will make a first evaluation under actual conditions of chimio-oncogramme.

a fragment of colon tumors will be taken from a specimen or a cold biopsy, tissue from patients diagnosed with colon carcinoma metastatic (stage 4). in parallel and systematically: analysis by the pathologist of a histological section. * culturing the cells obtained from the tumor by oncomedics fragment in a defined medium and provided for enriching tumor cells compared to stromal cells. * maintaining the cells in culture for 7 days. * effects of conventional chemotherapy (corresponding to protocols) on these cells for 72 hours (growth chambers) by oncomedics (chimio-oncogramme). * for each chemotherapy tested, measuring the proportion of dead cells / total cells. * retained by oncomedics results, not given to the nursing team. the patient will be treated and followed up in the usual way. * at the end of the study, comparing the in vitro results (chimio-oncogramme) to the patient's response to (x) the same (s) chemotherapy (s).

Eligibility criteria:
inclusion criteria: * patient with adenocarcinoma of the colon diagnosed at stage 4 receiving standard therapy * targets must be measurable tumor lesions (recist) * patient has not expressed opposition to the use of their residual tumor exclusion criteria: * against-formal indication to an indispensable para-clinical examination of the patient monitoring * use of chemotherapy, hormone therapy or concomitant radiotherapy * cons-indication for chemotherapy * are pregnant, nursing or lack of contraception for women of childbearing age.
confirmation bias towards treatments of depressive disorders in social tagging

Conditions: Major Depressive Disorder, Recurrent; Depressive Episode; Depressive Disorder, Major; Depression

Summary: the study examines whether people primarily want to confirm their prior attitudes in health-related information search, in an online environment using social tags for navigation. participants were looking for information on the treatment of depression with antidepressants and psychotherapy. they were randomly assigned to two groups with either high or low credibility of the community who provides social tags, and two groups where participants' confidence in prior attitudes was heightened or lowered, and to two groups where either antidepressant tags were more popular or psychotherapy was more popular. the investigators measured attitude change toward the treatments and also navigation behavior.

in health-related, web-based information searches, people should select information in line with expert (vs nonexpert) information, independent of their prior attitudes and consequent confirmation bias. this study aimed to investigate confirmation bias in mental health-related information searches, particularly (1) if high confidence worsens confirmation bias, (2) if social tags eliminate the influence of prior attitudes, and (3) if people successfully distinguish high and low source credibility. in total, 520 participants of a representative sample of the german web-based population were recruited via a panel company. among them, 48.1% (250/520) participants completed the fully automated study. participants provided prior attitudes about antidepressants and psychotherapy. the investigators manipulated (1) confidence in prior attitudes when participants searched for blog posts about the treatment of depression, (2) tag popularity -either psychotherapy or antidepressant tags were more popular, and (3) source credibility with banners indicating high or low expertise of the tagging community. the investigators measured tag and blog post selection, and treatment efficacy ratings after navigation.

Eligibility criteria:
inclusion criteria: online population - internet browser, representative sample of germans with respect to age and region exclusion criteria: no internet browser

Keywords: depression mood disorder information search attitudes psychotherapy antidepressants
approach to vascular access after renal transplantation

Conditions: Kidney Transplantation

Summary: the aim of the project is to assess the effect of functioning avf in renal transplant patients on fibrosis, inflammation and lvh indicators. clinical and laboratory parameters will be compared in a group of 150 patients, 75 patients with a functioning fistula and 75 patients with inactive vascular access. we will assess the impact of functional avf and the levels of biomarkers on the survival of patients and transplanted kidneys.

patients after kidney transplantation during a routine visit will be asked to participate to the study. in eligible a number of studies will be conducted: * detailed clinical examination * routine laboratory tests * lung ultrasound * muscle strength with a dynamometer * ultrasound assessment of upper limb vessels with assessment of fistula function (in the case of active fistula) and for the possibility of future vascular access * blood collection and protection (10-15 ml) for biomarkers * survey eq-5d-5l and lvd-36 * functional strength test. the obtained clinical data and test results will be subject to statistical analysis after anonymization. the impact of individual parameters on long-term prognosis will be assessed.

Eligibility criteria:
inclusion criteria: * age\> 18 years old * kidney transplant * \>12 months after transplantation * stable transplanted kidney function * signed informed consent exclusion criteria: * gfr \<15 ml / min * severe infection within 3 months of testing * increase in creatinine concentration\> 0.5 mg / dl within 3 months before the test * active cancer * signs of severe heart failure (nyha iv)

Keywords: arteriovenous fistula
variability in nocturnal oxygen parameters in suspected obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: the investigators would like to evaluate the variability of oxygen (and ppg) parameters during 7 nights at home. oxygen (and ppg) parameters will also be evaluated during 1 night at the hospital (diagnostic polysomnography). based on currently developed algorithms, surrogate apnea-hypopnea index (ahi), cardiovascular status and the variability of these parameters will be evaluated.

the main objective of this trial is to evaluate the variability in nocturnal oxygen (and ppg) parameters during 7 consecutive nights at home and to identify clinical predictors of variability in patients with suspected osa. data regarding sleep position, alcohol intake and sleep duration will be evaluated (these parameters could be important to explain variability). additional objectives are to compare the parameters measured at home with the parameters measured during an in-hospital polysomnography. the investigators will also evaluate variability in the surrogate ahi described by the group based on the measurements at home and the impact of multi-night evaluation of oxygen (and ppg) parameters on the recently developed mics algorithm will be explored. this study is a first explorative approach for further (multi-site) work to define the burden of osa associated with cardiovascular or psychofunctional problems.

Eligibility criteria:
inclusion criteria: * patients with suspected osa with a clinical indication to perform a polysomnography exclusion criteria: * patients younger than 18 yrs * patients not able to read or understand the informed consent content on the purpose of the study, due to visual, intellectual or language issues * patients with neuromuscular disease or chest wall disease with suspected hypoventilation

Keywords: oximetry
cognitive behavioral therapy combined with antidepressants to reduce hiv risk and drug relapse among depressed intravenous drug users

Conditions: HIV Infections; Depression; Substance-Related Disorders

Summary: this study will evaluate the effectiveness of combining cognitive behavioral therapy (cbt) and antidepressants in reducing hiv risk behavior and drug relapse rates in depressed intravenous drug users.

depression is common among injection drug users (idus); it is estimated that up to 50% of idus meet the diagnostic criteria for major depressive disorder, a severe form of depression. the combination of drug abuse and depression increases the likelihood of engaging in hiv high-risk behaviors such as unprotected sex and the use of unhygienic needles to inject drugs. research has shown that idus who receive treatment for depression have lower rates of drug relapse and are less likely to engage in high-risk sexual behavior compared to idus who have not received treatment for depression. combination treatment, which includes cognitive behavioral therapy (cbt) and antidepressant medication, has been shown to be the most effective treatment for depression. this study will evaluate the effectiveness of combination treatment in reducing hiv risk behaviors and drug relapse rates in cocaine or opiate addicted idus with a diagnosis of depression. in this 9-month study, participants will be randomly assigned to either a combination treatment group or an assessment only group that will receive no treatment. participants assigned to combination treatment will receive the antidepressant celexa, and will attend 8 cbt sessions and 7 psychopharmacology sessions. each cbt session will last about 60 minutes and each psychopharmacology session will last about 15 minutes. if a participant does not respond well to celexa, wellbutrin or effexor may be taken instead. participants in both groups will attend 4 study visits during which they will complete standardized psychological questionnaires and interviews to assess depression levels, drug use, and high-risk sexual behaviors. blood will be drawn at baseline and month 9 for hiv testing.

Eligibility criteria:
inclusion criteria: * meets dsm-iv criteria for major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia * score of greater than 14 on the hamilton depression rating scale * involved in hiv risk behaviors * current opiate or cocaine use * basic proficiency in english exclusion criteria: * current suicidal risk or ideation * current psychotic symptoms * simultaneous medical disorder that might make psychopharmacological treatment medically inadvisable * history of bipolar disorder, schizophrenia, schizo-affective disorder, schizophreniform disorder, or paranoid disorder * currently taking other medications for depression

Keywords: cognitive behavioral treatment for depression antidepressant psychopharmacology hiv risk behavior injection drug use
effects of pectin supplementation in diarrhea-predominant irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to investigate the effect of pectin, a kind of soluble dietary fiber, on clinical symptoms, gut microbiota and the immune status in patients with diarrhea-predominant irritable bowel syndrome

patients were randomized to receive either pectin or placebo. treatment consisted of 6 weeks supplementation with pectin (fiber group) or placebo (maltodextrin). we evaluated the clinical symptoms, gut microbiota and the immune markers in two groups.

Eligibility criteria:
inclusion criteria: * all patients(age≧18y) * admitted for diarrhea-predominant irritable bowel syndrome exclusion criteria: * mental disorders * cancer * inflammatory bowel disease

Keywords: irritable bowel syndrome gut microbiota soluble dietary fiber
clinical study to evaluate the efficacy of blood purification therapy on cholesterol crystal embolism

Conditions: Cholesterol Embolism

Summary: the aim of this study is to evaluate efficacy and safety of blood purification therapy on renal dysfunction by cholesterol crystal embolism.


Eligibility criteria:
inclusion criteria: patients who meet all of the following criteria. * patients who had cardiac catheterization or vascular surgery in the last 24 weeks before the time of obtaining informed consent. * patients who satisfy all of the following criteria or are diagnosed as cce by skin or renal biopsy. 1. patients with progressive renal dysfunction in the course of weeks or months. 2. patients with skin lesions such as livedo reticularis of lower extremities or blue toe syndrome. 3. eosinophil count is more than 400 per microliter. * patients who or patients whose legal representative understood the requirements of the study and signed the informed consent forms. exclusion criteria: patients who meet any of the following criteria will be excluded. * patients with contraindication to anticoagulant (nafamostat mesilate). * blood purification therapy is inapplicable because of severe heart failure, acute myocardial infarction, severe arrhythmia, acute stroke, or severe uncontrollable hypertension or hypotension. * patients with body weight less than 40kg. * patients with a history of allergic reaction or hypersensitivity to blood purification. * patients who cannot stop taking ace inhibitors. * patients with any disease in which corticosteroid, statin are contraindicated. * patients participated in another clinical trial or study at the time of obtaining informed consent. * patients receiving chronic hemodialysis. * otherwise, patients who are judged by the investigator as being unsuitable for inclusion in the study.
wearables for the bladder: an in-home treatment feasibility pilot study

Conditions: Multiple Sclerosis; Urinary Bladder, Overactive

Summary: the goal is to investigate the feasibility and effects of adding "wearables for the bladder" devices to conventional pelvic floor physical therapy (pfpt) to bladder function, in people with multiple sclerosis (ms).

the participants baseline pelvic floor and bladder function will be assessed by a pelvic floor physical therapist as per standard care, and online ms-symptom questionnaires (i.e., quality of life, bladder bother/symptoms, falls, fatigue, depression). participants will be trained on the maintenance and use of "wearable for the bladder" (web) devices. participants will receive standard pfpt intervention care, and will be asked to further train using the web devices. 8-10 sessions will be conducted over telehealth or in person as per standard protocol. at 12 weeks, participants will return to clinic for pelvic floor and bladder function assessment. a control group will receive standard pfpt intervention care as well as online ms-symptom questionnaires.

Eligibility criteria:
inclusion criteria: * ms diagnosis * assigned female at birth and whose sex is currently female * mild/moderate bladder dysfunction (bowel/bladder functional systems scores = 0-2 or bladder control scale \>0) * california residents * wifi in the home and personal smartphone (using apple operating system) * able to walk with or without assistive device * manual muscle test score of 2 or more. exclusion criteria: * undergone treatment for bladder dysfunction symptoms within 3 months * current urinary tract infection * recent (\~30 days) relapse * any cognitive, dexterity or visual impairment so severe that it precludes use of the wearables for the bladder tool or ability to use a smartphone * pregnancy

Keywords: multiple sclerosis remote wearables overactive bladder pelvic floor physical therapy
psycho-social impact of anti-nmdar encephalitis

Conditions: NMDAR Antibody-associated Auto-immune Encephalitis

Summary: nmda receptor encephalitis is a rare neurological autoimmune disease with severe neuropsychiatric symptoms, but a typically good functional neurological outcome. the majority of patients experience long-term cognitive, psychological and social impairments that have significant consequences for their well-being and quality of life. however, as the disease was only recently discovered (dalmau and al. annals of neurology, 2007), this psycho-social impact has not been studied systematically and the resulting consequences for patients are not adequately appreciated. the proposed study aims at characterizing the cognitive and psycho-social long-term consequences of this rare disease. our main hypothesis is that nmdar encephalitis has a persistent and clinically relevant impact on the patients' long-term cognitive, psychological and social well-being. furthermore, we hypothesize that longterm subjective outcomes depend on both internal and external factors, such as acute disease course, access to post-acute care, caregiver support, personal coping strategies, or access to health education resources and peer group support.


Eligibility criteria:
inclusion criteria: * patients with anti-nmdar encephalitis * year ≥ 18 ans * patients affiliated to the social security scheme exclusion criteria: * patients with no anti-nmdar encephalitis * minor patient * patient under guardianship or curatorship * patient with preexisting neurological symptoms

Keywords: auto-immune encephalitis nmda receptor encephalitis health-related quality of life psyco-social impact cognitive consequence
registry to assess safety for subjects that have completed a juventas sponsored hf protocol under ind # 14203

Conditions: Ischemic Heart Failure

Summary: this is an exploratory registry that will include subjects who have been randomized to receive jvs-100 treatment (at one of multiple doses) or placebo by one of a number of delivery systems (e.g. endomyocardial injection, retrograde infusion) in a previous juventas clinical trial.

this registry will assess the ongoing safety of subjects including morbidity/mortality parameters as they relate to heart failure and track any newly diagnosed malignancies. the logistics of the study are as follows: to be eligible, subjects must have actively participated in a juventas sponsored trial under ind 14203. after consent, subjects will be followed for up to three years post receipt of investigational product during which time they will receive phone calls (every 3 months) from the study site asking about their health. questions will be aimed at cardiovascular related events including: * hospitalizations * er visits * unscheduled visits with cardiologist * newly diagnosed malignancies serious adverse events (saes) will not be reported in this study; however, data pertaining to such events will be captured (i.e. date of admission and diagnosis.). data will be captured on paper crfs, collected by juventas (or their designee) and will be entered into a clinical database for analysis.

Eligibility criteria:
inclusion criteria: * participated in and completed a juventas sponsored heart failure study under ind 14203 exclusion criteria: * unwillingness to sign informed consent form * unwillingness or inability to receive phone calls for required follow up assessments * subjects actively participating in another regenerative medicine trial should be discussed with sponsor prior to enrollment