Kornimate/medical-research-clean huggingface dataset:
efficacy observation on tian jiu therapy for asthma

Conditions: Asthma

Summary: objectives: to further evaluate the immediate, long-term and cumulative effects of tian jiu therapy on asthma. hypothesis to be tested: the efficacy of tian jiu therapy on asthma is also long-term and will be accumulated. design and subjects: recruiting 167 asthma participants who received tian jiu therapy under the primary study of hkctr-1128. all subjects should be above age 13 and receive the same tian jiu therapy, 3 times per year from 2013 to 2015. a one-year follow-up after the last tian jiu treatment will be conducted. study instruments: modern usb pc-based spirometer and fingertip pulse oximeter. interventions: plastering some stimulating chinese herbal cubes on certain acupoints in the three hottest days of each year, for three consecutive years. main outcome measures: pulmonary function test, blood oxygen test, quality of life and standardized questionnaire on asthma attack and symptoms will be administered before treatment, after treatment of each year and one-year follow-up after the last treatment. data analysis: all the parameters will be analyzed, the physical improvement (cured, remarkably effective, effective and ineffective) will be recorded, and the differences in different treatment courses will be investigated and compared with previous data obtained in the primary study of hkctr-1128 by using standard statistical analysis. expected results: the effect of tian jiu therapy on asthma is not only immediate but also long-term and will be gradually accumulated. the tian jiu therapy will acquire better efficacy on asthma if this treatment was conducted more years continuously.


Eligibility criteria:
inclusion criteria: - history of asthma diagnostic criteria of asthma according to u.s.dhhs(2007): 1. episodic symptoms of airflow obstruction 2. difficulty breathing 3. chest tightness 4. cough (worse at night) 5. symptoms occurring or worsening at night, awakening the patient 6. symptoms occurring or worsening with exercise, viral infections, changes in weather, strong emotions, or mens; or in the presence of animals, dust mites, mold, smoke, pollen, or chemicals 7. wheezing 8. airflow obstruction at least partially reversible medically stable and acute medical care does not require. e.g. intensive monitoring, invasive ventilation, haemoid-dialysis, cardiac support. exclusion criteria: 1. patients currently experiencing acute asthma attack 2. infants and child under thirteen years old 3.pregnant women 4. patients with 1. fever and pharyngitis 2. tuberculosis 3. severe cardiac and pulmonary diseases 4. diabetes mellitus 5. hypersensitive skin condition 6. allergy to topical medication 7. keloid 8. bleeding disorders 9. severe heart diseases and with pacemaker.
combination therapy of betaseron-prograf in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of the study is to evaluate the safety and tolerability of a combination of interferon beta 1-b (betaseron®) and tacrolimus (prograf®) in patients suffering from multiple sclerosis (ms) who have failed treatment with currently approved drugs for ms prograf is an immunosuppressant that weakens the immune reactions responsible to protect the organism against infections. it is currently available on the market for patients who have received an organ transplant, to prevent rejection. because of its effect on the immune system, theoretically, prograf should exert a significant effect in ms. it has been tried in a small number of ms patients at a lower dose than the one used in organ transplant, however the results of the study did not allow to draw definite conclusions on its safety and efficacy in ms. betaseron is approved in canada for the reduction of the frequency of relapses in patients with relapsing-remitting ms and for the slowing of progression and reduction of the frequency of relapses in patients with secondary-progressive ms. the combination of betaseron and prograf may result in an additive effect or an increase in the actions of the drugs. however, the combination of the two drugs has never been studied. the aim of this study is to see how well the combination of betaseron and prograf is tolerated by patients with ms. the side effects of the treatment, if any, will be followed. in addition, the efficacy of the combination will be evaluated.


Eligibility criteria:
inclusion criteria: * relapsing-remitting or secondary-progressive multiple sclerosis * patients who have failed treatment with approved immunomodulator drugs (having experienced same or higher annual relapse rate or having experinced progression on the edss scale) * expanded disability status scale (edss) score less than 7.0 exclusion criteria: * any of the following conditions: diabetes mellitus, uncontrolled hypertension, active infection or viral diseases

Keywords: multiple sclerosis betaseron-prograf patients of multiple sclerosis secondary progressive type relapsing-remitting type
si-613 study for knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the objective of the study is to evaluate the efficacy and safety of intra-articular injections of si-613 compared with placebo for knee oa.


Eligibility criteria:
inclusion criteria: * provides their written informed consent. * has a diagnosis at the time of screening of oa of the knee according to american college of rheumatology (acr) criteria * is willing to switch to using acetaminophen as a rescue medication exclusion criteria: * has a body mass index (bmi) greater than or equal to 40 kg/m2 at screening. * secondary oa * is a female subject who is pregnant or lactating. * is currently hospitalized or has a planned hospitalization during the life of the study.

Keywords: knee osteoarthritis intra-articular injection
low-dose naltrexone for the treatment of complex regional pain syndrome

Conditions: Complex Regional Pain Syndrome

Summary: the investigators are testing treatment with low-dose naltrexone (ldn) for symptom relief of complex regional pain syndrome (crps). study participants will be randomly assigned to receive either ldn or placebo for a period of several weeks. during this period participants will be asked to attend either in-person or virtual study visits and complete questionnaires.


Eligibility criteria:
inclusion criteria: * upper and/or lower extremity crps * on stable treatment for 1 month * crps for at least 1 year * meet the budapest criteria for crps at time of the study. exclusion criteria: * any known allergy to naltrexone or naloxone * use of prescription opioid analgesics or illegal opioid use * current or planned pregnancy.
taxoprexin treatment for advanced skin melanoma

Conditions: Metastatic Melanoma

Summary: to evaluate objective response rate and duration of response to weekly taxoprexin®. to evaluate the safety profile of weekly taxoprexin® in this patient population. to evaluate overall survival in the same patient population. to evaluate time to disease progression, and the time to treatment failure in patients with metastatic malignant melanoma being treated with weekly taxoprexin® injection.

this is a phase ii open-label study of weekly taxoprexin® injection in patients with metastatic malignant melanoma who have not received cytotoxic agents for advanced disease. patients may have been previously treated with immunological agents including il-2 and vaccines. patients will receive taxoprexin® injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or investigator decision.

Eligibility criteria:
inclusion criteria: 1. patients must have malignant skin/mucosal (non-choroidal) melanoma, and documented metastatic disease. 2. patients must have at least one measurable lesion. 3. patients must not have received prior systemic chemotherapy for metastatic disease. prior treatment with immunotherapy or vaccine therapy is allowed. 4. at least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy. 5. at least 4 weeks (28 days) since prior radiotherapy to \> 20% of the bone marrow and prior adjuvant chemotherapy. 6. patients must have ecog performance status of 0 - 2. 7. patients must be \> 13 years of age. the safety of taxoprexin has not been adequately studied in younger patients. 8. patients must have adequate liver and renal function. 9. patients must have adequate bone marrow function. 10. life expatancy of at least 3 months 11. patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution. exclusion criteria: 1. patients who have received prior therapy with any taxane. 2. patients whose primary site was the choroid (eye). 3. patients who have a past or current history of neoplasm other than the entry diagnosis, except for curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix or other cancers treated for cure and with a disease-free survival longer than 5 years. 4. patients with symptomatic brain metastasis (es). 5. patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. patients may not breastfeed while on this study. 6. patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals). 7. patients with current peripheral neuropathy of any etiology that is greater than grade one (1). 8. patients with unstable or serious concurrent medical conditions are excluded. 9. patients with a known hypersensitivity to cremophor.
effectiveness of exercise applications on hepatic steatosis and physical fitness in patients with nafld

Conditions: Nonalcoholic Fatty Liver Disease

Summary: purpose of the study will investigate the effects of two different training programs on hepatic steatosis and physical fitness parameters. this trial is designed in a randomized controlled study plan and aerobic training (40 minutes) wil be combined with whole body vibration training (wbvt for 15 minutes) which is made up of a shorter time application. wbvt to be applied instead of the resistance exercises.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of nafld * age range of 18-65 years * participants who are not in an active exercise program * participants who are not on an active diet program exclusion criteria: * pregnancy * chronic inflammatory process * rheumatic disease * cognitive disorders * obstacles to achieve physical performance tests * presence of other conditions that may cause liver steatosis * inability to do wbvt or aerobic exercises

Keywords: aerobic exercise whole body vibration therapy
biomolecular markers of bone metastasis

Conditions: Bone Metastasis

Summary: the goal of this clinical trial is to characterize the biomolecular profile of bone metastases to define the predisposing profiles of bone metastasis, in patients with breast or lung or renal carcinomas or of the gastroenteric or prostate tract with bone metastasis. the main question it aims to answer is: is it possible to predict the progression of bone metastasis by identifying biomarkers as risk factors for bone metastasis?

metastasization is a process that involves molecular change: potentially colonizable healthy tissues, particularly bone marrow, may "respond" to the production of factors released by the primary tumor, changing some of their funcional molecular characteristics in order to facilitate colonization by circulating tumor cells. this study aims to describe the biomolecular profile of bone metastases. for this purpose, as per normal clinical practice, patients with carcinomas and who have developed bone metastases will undergo sampling of the metastases and primary tumors. the activities will have multidisciplinary management. the study will include patients with carcinoma with bone metastases for whom the collection of biological material from the primary lesion and/or bone metastasis is an integral part of the diagnostic-therapeutic procedure or patients for whom, by clinical practice, a biopsy collection is performed because: * histologic evaluation of the primary or metastatic lesion has been requested; * a pathologic fracture to be treated surgically occurs; * prophylactic orthopedic stabilization is required. these samples will later be analyzed from a molecular point of view in order to identify a biomolecular profile that can help in defining profiles predisposing to bone metastasis and profiles predisposing to pathological fracture risk. unsupervised analysis of the emerged transcriptomes will be conducted: 1. regardless of tumor histotype (in order to highlight any common facilitating factors for bone metastasis and osteolytic activity), 2. by histotype, 3. by type of metastasis (osteolytic vs osteosclerotic). to eliminate analysis error and bias, analyses will be conducted on fresh samples from needle biopsy or intraoperative sampling. emerging evidence on transcriptomic analysis will be validated with protein analysis methods and compared with evidence alreadỳ available in the literature. the analysis being conducted for this study does not influence clinical practice, and all procedures are part of normal clinical practice in the management of patients with bone metastases from carcinoma.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * patients with breast or lung or renal or gastroenteric tract or prostate with bone metastases * patients who knowingly express willingness to participate in the study after signing the written informed consent exclusion criteria: * none

Keywords: bone metastasis biomolecular profile
novel epothilone (bms-247550) in patients with metastatic breast cancer (mbc)

Conditions: Breast Cancer; Metastases

Summary: the purpose of this research study is to assess the response rate of the investigational drug bms-247550 (ixabepilone) in women with metastatic breast cancer who are refractory to an anthracycline, a taxane, and capecitabine.


Eligibility criteria:
inclusion criteria: * patients must have received all 3 drugs- an anthracycline, taxane, and capecitabine (alone or in combination) and be resistant * no more than 3 prior chemotherapy regimens in the metastatic setting * must have at least one target lesion that is radiographically measurable * good performance status * no history of or current brain or leptomeningeal disease

Keywords: metastatic breast cancer
feasibility and limitations of offering community based rapid hiv testing to men who have sex with men (msm)

Conditions: HIV Infections

Summary: objective: this research agreement brings together french and canadian teams of scientists, hiv testing centers and community based partners. the aim is to explore the feasibility and limitations of offering community based rapid hiv testing to men who have sex with men (msm).

background: studies have shown that knowing one's own hiv positive status, may lead to a reduction in sexual risk behaviours. the introduction of new forms of rapid hiv testing in urban areas, may be of benefit to the public health sector, notably in identifying primary hiv infection, preventing secondary hiv transmission and decreasing the spread of hiv infection. studies have also shown that rapid hiv testing, which yields same-day results, enables a greater number of individuals in populations at risk to become aware of their hiv status. issue: the working hypothesis is that the current screening system is not sufficiently suitable for msm. a community-based rapid hiv testing program could better target the high risk msm population and shorten the delay between risky behaviour and hiv testing. design: this intervention could enable the assessment of the feasibility of community-based rapid hiv testing. moreover it could compare traditional cdag (free anonymous screening consultation or centre de dépistage anonyme et gratuit in french) center testing with community-based rapid testing. a pre-study phase is first realised to characterize those in the msm population undergoing hiv testing, before promoting and then beginning the survey. during the normal opening hours of five testing centers, clients will be randomized to have a rapid finger-stick blood specimen test or a conventional test. during evenings and week-ends (i.e. when the centers are closed) only community based rapid hiv testing will be proposed. schedule: the pre-study phase is planned for the first quarter of 2009. promotion of the survey will begin one month before the experimental study which in turn will start in the third quarter of 2009 and will run for 7 months. the end of data analyses is planned for the end of 2010. outcome: we will compare hiv population exposure, screening history and the frequency of primary hiv infection diagnosis. we expect to find that those msm who undergo community based hiv testing during evenings or week-ends, is a population who take repeated sexual risks and who have repeated hiv testing. we also expect to find that this form of testing will be characterized in terms of satisfaction as non-inferior compared to the classic one. in the long term, and if the results are confirmed, rapid hiv testing could be extended to strictly community-based sites.

Eligibility criteria:
inclusion criteria: * men who have sex with men * age ≥ 18 years * able to give written consent * able to give written authorization for lifting anonymity if there is doubt of results * covered by french social security exclusion criteria: * who have had a previous diagnosis of seropositivity * treated by antiretroviral * woman
evaluation of a therapeutic mobile app for depression

Conditions: Depression

Summary: the purpose of this study is a preliminary evaluation of a gamified attention bias modification training (gambt) for reducing symptoms of depression and rumination. individuals with elevated symptoms of depression will use the digital intervention over the course of 4 weeks. they will complete a brief (\~5 question) survey daily, as well as weekly assessments.

this study aims to assess the feasibility and efficacy of the digital therapeutic attention bias modification (abm) intervention that targets and reduces negative attention bias among adults with elevated symptoms of depression. consistent with the experimental therapeutics approach abm has been shown to both reduce negative attention bias and improve symptoms of depression. however, engagement with these tasks have been mixed, with some participants describing traditional abm tasks as boring. this had led to the development of gamified versions of abm with the intent to improve participant engagement. nevertheless, there have been very few rigorous trials of abm for depression, and no one to our knowledge has used ecological momentary assessment to tease apart the mechanisms by which abm can lead to improvements in depression symptoms. participants will access the intervention on their mobile smart phone and complete treatment over a period of 4 weeks. enrolled participants will be randomly assigned to one of two groups: gamified attention bias modification training, or gamified placebo training. they will complete brief (\~5 questions) daily surveys, as well as weekly remote assessments of attention bias and depression symptoms.

Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent; * fluent in english; * normal or corrected-to-normal vision * moderate or greater depression symptoms (defined as greater than or equal to 10 on the phq-8); * attention bias for negative stimuli (operationalized as greater than an average of 6500 ms of dwell time on sad faces in an attention bias task); * stable psychiatric and neurological medication usage. * access to a smartphone for downloading the app and a laptop or desktop computer to complete the weekly assessments exclusion criteria: * recent heavy alcohol use defined as a score of 2 or higher on the pdsq * past or present comorbidity of other serious mental illness (e.g., schizophrenia, substance use disorder, bipolar disorder, etc.) * previous experience with gamified attention bias modification app
pilot study of acthar® gel in chronic inflammatory demyelinating neuropathy

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy

Summary: the purpose of this pilot study is to assess the safety and efficacy of acthar® gel in chronic inflammatory demyelinating polyneuropathy (cidp) patients.


Eligibility criteria:
inclusion criteria: * cidp diagnosed according to the european federation of neurological societies/peripheral nerve society (efns/pns) criteria 2010 * age \> 18 years * able to give written informed consent * patient's signs and symptoms should not be better explained by another disease process * patients can be on prednisone as long as there has been no dose change for 4 weeks from baseline * patients can be on following drugs as long as there has been no change for 60 days from baseline visit including azathioprine, cyclosporine, cyclophosphamide, mycophenolate mofetil, intravenous immunoglobulin (ivig) or other immunosuppressive drugs * incat score greater than or equal to 2 exclusion criteria: * presence of any other causes of polyneuropathy or multifocal motor neuropathy, which in the opinion of the investigator is the major contributor to the numbness and weakness. * other neurologic or orthopedic condition causing weakness * treatment with plasma exchange (plex) within the last 30 days from baseline * participation in another trial within the last 30 days from baseline or two ½ life of the drug being studied. * latent tuberculosis or active infection * contraindication per acthar® gel prescribing information scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history or presence of peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical hyperfunction. * history of prior sensitivity to acthar® gel or other porcine products * previous or present infection with hepatitis c and hepatitis b * pregnancy or nursing mothers. * female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.