Kornimate/medical-research-clean huggingface dataset:
phase ib study to evaluate mor103 in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a chronic inflammatory disease associated with central nervous system (cns) demyelination and subsequent axonal degeneration. multiple sclerosis exhibits an unpredictable and variable clinical course. multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have been identified to contribute significantly to demyelination in both clinical ms and animal models of ms. granulocyte-macrophage colony-stimulating factor (gm csf) stimulates proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic cells and microglia with subsequent induction of proinflammatory biomolecules. therefore blocking gm csf activity might be a therapeutic approach for the treatment of ms.

recent clinical studies demonstrated a possible dysregulation of the balance of pro and anti inflammatory lymphocytes, which may contribute to the pathogenesis of ms. it was shown in animal models of eae that during the disease effect or phase gm csf sustained neuroinflammation via myeloid cells that infiltrate the cns proving an essential role of gm csf in encephalitogenicity.

Eligibility criteria:
key inclusion criteria: outpatients with a diagnosis of rrms or spms, who are currently not being treated and who have at least 1 of the following: * at least 1 documented relapse within 1 year before screening, or * two documented relapses within the past 2 years before screening, or * a new gadolinium (gd)-enhancing lesion on magnetic resonance imaging (mri) t1-weighted imaging within 1 year before screening, or * a new t2 lesion on mri within 1 year before screening. the patient must have 10 or less, gd-enhancing lesions per t1-weighted mri at screening as assessed by a central reader. the patient must be able and willing to ambulate, with an expanded disability status scale (edss) score of ≥ 2.0 and ≤ 6.5 at both the screening visit and the baseline visit key exclusion criteria: 1. a patient with primary progressive ms (ppms) 2. a patient who has previously received at any time any of the following * b-cell or t-cell depleting therapies * cytotoxic agents, any immunosuppressive/immunomodulating agents 3. a patient who has not stabilized, in the opinion of the investigator 4. a patient with any medical condition or uncontrolled disease states other than ms requiring or likely to require systemic treatment with corticosteroids or other immune compromising agents 5. a patient with current or a history of major chronic inflammatory autoimmune diseases other than ms 6. a patient with any type of infection 7. patients on chronic prophylactic or suppressive antibiotic, antifungal,or antiviral agents 8. a patient with a history of tuberculosis. 9. a patient with any signs of excretory hepatic or kidney dysfunction 10. a patient with a positive test for hepatitis b or hepatitis c
efficient self-management of chronic disease using health information technology - a study on hypertension

Conditions: Hypertension; High Blood Pressure

Summary: background: hypertension is an increasing global problem and measures are needed against the emerging hypertensive burden. management of the risk factor hypertension consists of medical treatment in conjunction with lifestyle adjustment, whereby lifestyle adjustment is the preventive cornerstone but has also been proven to contribute to bp reduction among those already receiving medical drug treatments. non-adherence is a significant barrier to successful hypertension management. goal: to improve management of hypertension in daily life from a person-centred perspective, utilizing information and communication technology, and further to decrease complications of hypertension. to increase the proportion of persons with hypertension obtaining a bp goal =\<140/90 mmhg and to conduct a health economic evaluation of our intervention. plan: the investigators will conduct a multi-centre randomized controlled trial in 36 primary care centres in three counties in sweden. there will be approximaely 430 patients in each group. bp will be measured in a standardized manner, laboratory tests taken and questionnaires answered at baseline, after eight weeks and after a year in both the intervention and the control group. register data on health care resource one year before baseline and for the full study period will be retrieved for participants in both study groups. singificance: the intervention is expected to improve adherence to treatment and a significant lowering of the blood pressure. hospitalization rates are lower among persons with hypertension that adheres to their medication. by improving treatment of hypertension the hope is to decrease complications and morbidity due to hypertension and thereby hospitalization and health care costs. due to the generic nature of the technology involved, the self-management system can easily be adapted to monitor other chronic conditions.


Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosis of hypertension * on treatment with at least one antihypertensive drug * understanding of swedish in order to be able to provide informed consent and to make use of the mobile phone based self-management support system. * mobile phone (patients will use their own mobile, but have the possibility to borrow one if needed) * patient at a primary healthcare centre in any of four participating healthcare regions in sweden (skåne, västra götaland, östergötland, and jönköping) exclusion criteria: * secondary hypertension * terminal illness * pregnancy-induced hypertension * cognitive impairment * impaired vision (not able to read messages on mobile phone) * psychotic disease

Keywords: person-centred care (pcc) self-efficacy
lymphoma follow-up

Conditions: Lymphoma

Summary: this follow-up protocol is designed to evaluate participants who have previously been lymphoma patients treated on approved clinical studies of the national institutes of health.

the intent of this protocol is to accrue up to 800 volunteers who are interested in participating in nia research studies as part of follow-up for previous cancer treatment at nih. participants will be asked to answer questions regarding their general health status, diagnoses, and admissions to hospital, and to provide possible documentation. they may be asked to come to the nia clinical research unit at harbor hospital to participate in a follow-up evaluation. they will have the opportunity to obtain additional information about studies in which they may wish to participate and to discuss eligibility issues with nia staff members. any identified clinical problems in need of care will also be discussed. volunteers may be referred, with their permission, to their private medical doctor for follow-up. they may be re-evaluated within a year for further follow-up. the follow-up evaluation may include history and physical, blood and urine tests, questionnaire, mri or ct.

Eligibility criteria:
inclusion criteria: * previously treated on an approved nci/nih protocols * willing and able to provide informed consent for current nia protocol * rare, unusual, interesting or unknown condition that requires diagnosis exclusion criteria: * does not meet the criteria of any previously-approved nih protocol.

Keywords: cancer
endobronchial ultrasound- transbronchial needle aspiration (ebus-tbna) versus mediastinoscopy for mediastinal lymph node staging of non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small Cell Lung

Summary: accurate staging of the mediastinum is essential to evaluate prognosis in non-small cell lung cancer and to devise an appropriate treatment plan. mediastinal staging by surgical techniques (mainly cervical mediastinoscopy) is considered to be the gold standard, although surgical staging is invasive, requires general anesthesia, and is subject to potential serious complications. endobronchial ultrasound (ebus)-transbronchial needle aspiration (tbna) is a new modality for the evaluation of mediastinal and hilar lymph node metastasis from lung cancer. compared to other diagnostic methods, ebus-tbna is a real-time procedure that enables multiple biopsies with high-quality histologic cores under local anesthesia. however, there have been few data on the head-to-head comparisons of mediastinoscopy and ebus-tbna. the aim of this prospective study is to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ebus-tbna and mediastinoscopy in identifying n2 and n3 lymph node for patients with non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * histology-proven non-small cell lung cancer * n2 or n3 lymph node invasion is suspected based on chest ct or pet/ct scans (at least one of three criteria) : 1) enlarged (1cm or more in short axis diameter) mediastinal lymph node(s), 2) fdg uptake in the mediastinal lymph node(s), or 3) fdg uptake in n1 node(s) * the patient is otherwise considered a candidate for a surgical treatment with the intention to cure exclusion criteria: * distant metastasis * inoperable t4 disease * confirmed supraclavicular lymph node metastasis * former therapy (chemotherapy or radiotherapy or surgery) for lung cancer * contraindications for bronchoscopy * uncorrected coagulopathy * concurrent other malignancies * suspicious mediastinal lymph node metastasis which are not accessible by ebus-tbna or mediastinoscopy (i.e. paraaortic, aortopulmonary window, or paraesophageal lymph nodes)

Keywords: cancer lung cancer ultrasound surgery
stereotactic body radiation therapy using hyperarc in treating patients with recurrent head and neck cancer

Conditions: Recurrent Head and Neck Carcinoma

Summary: this phase ii trial studies how well stereotactic body radiation therapy with hyperarc software technology works in treating patients with head and neck cancer that has come back. stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. this method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

primary objectives: i. to evaluate local control and toxicity of patients who receive escalated dose stereotactic body radiation therapy (sbrt) reirradiation with hyperarc for recurrent head and neck cancer (rhnc). secondary objectives: i. to evaluate the clinical benefit of hyperarc through the analysis of overall survival (os), progression-free survival (pfs) and locoregional progression-free survival (lpfs). exploratory objectives: i. to evaluate dosimetric data including dose to target and organs at risk (oar). outline: patients undergo treatment planning with both standard radiation treatment software and hyperarc software technology. the most optimal plan will be delivered to a total dose of 55 gy in 5 fractions, given 2-3 times weekly. after completion of study treatment, patients are followed up periodically for 1 year.

Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent head and neck cancer; either unresectable or status post salvage surgery. * history of radiation therapy for head and neck cancer with minimum 50% overlap of the 50% isodose line from prior treatment to the proposed treatment volume. * estimated life expectancy \> 12 weeks. * karnofsky performance status \>= 70 (eastern cooperative oncology group \[ecog\] 0-2). * maximum tumor, or tumor bed, diameter \< 5 cm. * if a woman is of childbearing potential, a negative serum pregnancy test must be documented. women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) for duration of study participation and for up to 4 weeks following the study treatment. * ability to understand and willingness to sign a written informed consent.
study to evaluate lenalidomide plus dexamethasone in patients with newly diagnosed poems syndrome

Conditions: POEMS Syndrome

Summary: the purpose of this prospective study is to determine the efficacy and safety of lenalidomide plus dexamethasone in patients with newly diagnosed poems syndrome.

the investigators propose to use the adverse effects as well as the need for dose reduction as a criterion to judge tolerability of treatment. the primary endpoint would be hematological response rate according to international myeloma working group (imwg) response criteria for amyloidosis and neurological response rate defined by overall neuropathy limitation scale (onls) score. this study expects to enroll approximately 41 subjects.

Eligibility criteria:
inclusion criteria: 1. patients must understand and voluntarily sign an informed consent form. 2. older than 18 years old at the time of signing consent. 3. meet the diagnostic criteria of poem syndrome. 4. must be cytotoxic treatment naive. however, previous or existing corticosteroid (prednisone or dexamethasone) or intravenous immunoglobin (ivig) therapy is allowed. 5. women of childbearing potential must understand that the study medication could have a potential teratogenic risk. they should undergo complete contraception during the study period. 6. male subjects must agree to use condoms throughout study drug therapy. exclusion criteria: 1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. pregnant or lactating females. 3. any of the following laboratory abnormalities: absolute neutrophil count(anc) of\ 3 times of the normal upper limit. 4. prior history of malignancies, but not including basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, and t1a or t1b prostate cancer. 5. known hypersensitivity or prior history of uncontrollable side effects to dexamethasone therapy. 6. prior use of cytotoxic drugs. 7. subjects who are unable or unwilling to undergo antithrombotic therapy.

Keywords: poems syndrome lenalidomide newly diagnosed plasma cell disorder dexamethasone
epidemiological study to evaluate adherence to treatment in bipolar disorder: adherence study

Conditions: Bipolar Disorder

Summary: the purpose of this study is to estimate adherence to treatment in bipolar patients, to characterize patients based on adherence degree and to describe the variables linked to poor adherence to treatment in real-life practice.


Eligibility criteria:
inclusion criteria: * patients diagnosed with bipolar disorder i or ii dsm-iv * patients treated with at least one oral antipsychotic * subjects able to read and write exclusion criteria: * patients participating in clinical trials

Keywords: bipolar disorder adherence treatment real life practice
gene therapy ada deficiency

Conditions: Adenosine Deaminase Deficiency

Summary: adenosine deaminase deficiency is an inherited disorder that results in severe abnormalities of the immune system and leaves children unable to fight infection. this trial aims to treat adenosine deaminase deficiency patients using gene therapy.


Eligibility criteria:
inclusion criteria: 1. patients who lack a human leukocyte antigen (hla)-genotypically identical bone marrow donor or phenotypically matched family or unrelated donor and who show incomplete immune reconstitution on polyethylene glycol-modified adenosine deaminase (peg-ada) enzyme replacement therapy (defined by absolute cd4+ count \<300 cell/mm3 and who remain on immunoglobulin replacement therapy) 2. diagnosis of ada-scid (severe combined immunodeficiency (scid) due to adenosine deaminase (ada)confirmed by dna sequencing or by confirmed absence of \<3% of ada enzymatic activity in peripheral blood or (for neonates) in umbilical cord blood erythrocytes and/or leukocytes or in cultured fetal cells derived from either chorionic villus biopsy or amniocentesis, prior to institution of peg-ada replacement therapy 3. parental/guardian/patient signed informed consent

Keywords: adenosine deaminase deficiency gene therapy
the individual therapy for patients with wilson's disease

Conditions: Wilson's Disease

Summary: based on the genotype characteristics and genotype-phenotype-treatment prognosis data of chinese wd patients, this study intends to further optimize the treatment regimen of chinese wd patients and formulate individualized treatment regimens for each genotype, so as to further improve the prognosis of patients.

the purpose of the study is to evaluate treatment regimen efficacy based on different mutations, and zinc treatment in presymptomatic wd patients.

Eligibility criteria:
inclusion criteria: * genetic diagnosis of wilson's disease * presymptomatic patients with wilson's disease exclusion criteria: * movement disorder due to other definite causes instead of wilson's disease * severe lung, kidney or liver disease * neoplastic disease
reducing hiv: safer sex skill building in pregnant drug abusing women

Conditions: HIV Infections; Substance Use

Summary: this study will examine safer sex skills building (ssb), a targeted behavioral hiv prevention and risk reduction group intervention in two samples of pregnant drug abusing women.

"safer sex skills building" in pregnant women: dace svikis, (psychology, ob-gyn, psychiatry) pi, diane langhorst (social work) and nichole karjane, (ob-gyn) co-investigators). this study will focus on increasing safer sex skills development among pregnant women at high risk for hiv infection. the "safer sex skill building" (ssb) program developed by el bassel and schilling (1991, 1992), has demonstrated efficacy in national studies in reducing sexual risk for hiv and other std transmission. this manual-driven, gender-specific intervention has proven effective in reducing sexual risk behaviors in both methadone maintenance and outpatient drug-free patients. to date, however, the intervention has not been tested with pregnant drug abusing women who may actually be at increased risk if they stop using condoms or continue drug use during pregnancy. this study will examine ssb, a targeted behavioral hiv prevention and risk reduction intervention in two samples of pregnant drug abusing women. using a 2x2 design, a randomized clinical trial will compare the five-session ssb group intervention to a one-session standard group hiv education intervention (se). study findings will provide benchmark data on the efficacy of ssb for hiv and std prevention in a diverse sample of pregnant drug abusing women.

Eligibility criteria:
inclusion criteria: * 18 years of age and older, pregnant * at prenatal care (pcc) site: screen positive for on t-ace and tweak and/or drug cage, report drinking 3 or more drinks on at least one occasion and/or using an illicit drug at least once in the 30 days prior to pregnancy awareness, and report at least one incident of unprotected penetrative (vaginal or anal) intercourse with a male partner within the six months prior to baseline assessment. * at community treatment (rbha) site, inclusion criteria are the same except post-partum women (i.e., those who gave birth to a child 2 years of age or less) will also be eligible for study enrollment. exclusion criteria: both sites: * unable to provide informed consent due to cognitive impairment, psychiatric instability, or language barriers

Keywords: hiv primary prevention health promotion health behavior risk reduction behavior sexual behavior safe sex women's health minority health pregnant women hiv seronegativity
a study of roactemra/actemra (tocilizumab) in combination with dmards versus current best practice dmard therapy in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this randomized, open-label, parallel-group study will assess the effect on disease remission of roactemra/actemra (tocilizumab) in combination with disease-modifying antirheumatic drugs (dmards) versus current best practice non-biologic dmard therapy in patients with moderate-to-severe active rheumatoid arthritis. patients who are randomly assigned to the roactemra/actemra treatment group will receive 8 mg/kg roactemra/actemra intravenously every 4 weeks. the anticipated time on study treatment is 12 months.


Eligibility criteria:
inclusion criteria: * adult patients, over the age of 18 years * diagnosis of moderate-to-severe active early rheumatoid arthritis (ra) of less than 2 years duration * das28 \>3.2 * swollen joint count (sjc) \>/=6 (66 joint count), and tender joint count (tjc) \>/=6 (68 joint count) * patients who have received dmards (including methotrexate) for 3-7 months exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline * rheumatic autoimmune disease other than rheumatoid arthritis (secondary sjögrens syndrome or nodulosis with ra is permitted) * functional class iii or iv as defined by acr classification of functional status in rheumatoid arthritis * prior history of or current inflammatory joint disease other than ra
intestinal microbial dysbiosis in chinese infants with short bowel syndrome with different complications

Conditions: Short Bowel Syndrome; Complications

Summary: there are no reports involved the intestinal microbiota from chinese infants with short bowel syndrome (sbs) under different clinical status. alterations in the microbiota are closely correlated with the bile acids and short chain fatty acids metabolism as well as the intestinal immunity. a relatively comprehensive profile composed of microbial structure, microbial metabolism products and immune biomarkers in sbs infants may facilitate a better therapy strategy to complications occurred in sbs children.

the investigators totally collected 26 fecal samples from 18 infants diagnosed with sbs during parenteral nutrition administration, and these samples were divided into three groups according to complications of enrolled patients at sampling time: asymptomatic group, central catheter-related blood stream infections group and liver injury group. 7 healthy infants with supplementary food were enrolled as control. fecal microbiota, siga and calprotectin, bile acids and short chain fatty acids were also detected by 16s ribosomal ribonucleic acid (rrna) gene sequencing, enzyme-linked immunosorbent assay and liquid/gas chromatography.

Eligibility criteria:
inclusion criteria: * infants with short bowel syndrome

Keywords: short bowel syndrome intestinal microbiota immune
the effect of ischaemic-reperfusion in man - a bradykinin dependent pathway

Conditions: Ischaemic Heart Diseases

Summary: heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. current treatments are designed to relieve this blockage as quickly as possible to minimize damage to the heart muscle. however in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. the aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. this will help the investigators to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility criteria:
inclusion criteria: * healthy males between 18-65 years of ages * non-smokers exclusion criteria: * any concurrent illness or chronic medical condition * concurrent use of vasoactive medication * smoking history

Keywords: ischaemia reperfusion bradykinin platelet activation endothelial function