Kornimate/medical-research-clean huggingface dataset:
germline alterations of tumor susceptibility genes in new york cancer patients

Conditions: Breast Cancer; Bladder Cancer; Kidney Cancer; Colon Cancer; Prostate Cancer; Lung Cancer; Ovarian Cancer

Summary: the basic premise of this research proposal is to determine whether there is any significant association between germline polymorphisms and cancers of colon, bladder, breast, testicular, prostate, ovaries, kidney, lung, lymphoid organs, and head and neck. this is an exploratory study designed to generate hypotheses for further research.

to establish significant correlations between genetic polymorphisms and cancer, a largescale, systematic comparison of genetic alterations utilizing a case-control methodology is proposed. to date, such studies have been limited due to the large number of samples necessary for obtaining statistical significance, and the lack of rapid and accurate methods to screen for genetic polymorphisms. we propose to utilize an anonymized design to obtain dna from residual material from routine diagnostic blood tests, to link these samples to a limited set of clinical variables, and to test for the frequency of candidate low-penetrance cancer susceptibility alleles. these data will be combined with similar data from a control group of age- and ethnically-matched volunteers for a related cohort study to be conducted separately. polymorphisms to be screened for include those involving the genes pten, apc, tgf βr-i, blm, chk2, a p85 phosphoprotein, atm, er, pr, mcp-1, mpif, ccr2/5, ccr3, and sult1a1. cancers to be included are breast, bladder, kidney,colon, testicular, lung, prostate, ovarian, lymphoid neoplasms, and head and neck carcinomas. genes with snps known to be relevant for either the development or treatment of lymphoid malignancies will also be targeted. specifically, candidate genes will be selected from 1) cytokine signaling, 2) dna repair, and 3) apoptosis regulatory pathways.

Eligibility criteria:
inclusion criteria: * patients with a histologic diagnosis of cancer of the colon, breast, bladder, kidney, testicles, lungs, prostate, head and neck, or lymphoid organs, who have donated a diagnostic blood sample as either an inpatient or outpatient at mskcc. * all patients who have two or more histologic diagnoses of the same primary tumor type involving the above sites. * patients of ashkenazi jewish ancestry with a histologic diagnosis of cancer of any type. * samples ascertained as part of protocol 98-024a(1) are also eligible for ascertainment in this study. exclusion criteria: * mskcc patients without a histologic diagnosis of cancer of the breast, bladder, kidney, colon, testicles, lungs, prostate, or lymphoid malignancy (including all types of lymphoma) will not be eligible for the amdec sponsored component of the study.
outcomes of cutaneous t-cell lymphoma and graft-versus-host disease with extracorporeal photopheresis treatment

Conditions: Cutaneous T Cell Lymphoma; Graft Versus Host Disease

Summary: extracorporeal photopheresis (ecp) is a form of apheresis and photodynamic therapy in which the peripheral blood is treated with 8-methoxypsoralen, which is then activated with uv light. ecp is currently a standard therapy for cutaneous t-cell lymphoma (ctcl) and is also effective for graft-versus-host disease (gvhd). the investigators would like to study the outcomes (response rates) of patients receiving ecp treatment and other factors relating to their disease and treatment, as well as procedural events, such as complications.

the investigators intend to report outcomes from the inception of this procedure at dartmouth-hitchcock medical center (dhmc) in may 2008 through 9/30/11. additionally, the investigators would like to maintain a prospective database of these patients so that new patient data can be collected for updating of outcomes.

Eligibility criteria:
inclusion criteria: * patients who receive extracorporeal photopheresis treatment * treated at dartmouth-hitchcock medical center * must be 18 years or older exclusion criteria: - none specified

Keywords: ecp ctcl extracorporeal photopheresis cutaneous t cell lymphoma gvhd graft versus host disease
combination pharmacotherapy for smoking cessation among methadone patients

Conditions: Tobacco Use Disorder

Summary: the purpose of this pilot study is to examine the effects of combined pharmacotherapy (zyban/nrt)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.

this is a one-arm, open label pilot study of mmt patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. the smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.

Eligibility criteria:
inclusion criteria: * patients in long-term methadone maintenance treatment * patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months exclusion criteria: * patients who use prescription drug regimens that might affect methadone or bupropion metabolism * patients with cardiovascular disease, asthma, copd * patients who are pregnant or breastfeeding * patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)
a study comparing crx-102 plus disease-modifying anti-rheumatic drug (dmard) therapy to placebo plus dmard therapy in ra

Conditions: Rheumatoid Arthritis

Summary: this study was a multicenter, randomized, blinded study comparing the effect of crx-102 plus dmard therapy to that of placebo plus dmard therapy on serum c reactive protein (crp) and cytokines in subjects with rheumatoid arthritis. this phase ii, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (ra).

the primary objective of this study was to: • compare the response of crx-102 plus dmard therapy to placebo plus dmard therapy in lowering crp levels in rheumatoid arthritis subjects. the secondary objectives of this study were to: * evaluate the changes in inflammatory cytokines in subjects treated with crx-102 plus dmard therapy to placebo plus dmard therapy. * evaluate the efficacy of crx-102 plus dmard therapy to placebo plus dmard therapy using acr-20 and das28 indices as well as fatigue scales.

Eligibility criteria:
inclusion criteria: * was 18 years of age of older * had moderate to severe ra * had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28) * had a baseline crp level of at least 2.2 mg/l and a das28 score \>4.5 * had been on dmard therapy for at least 3 months and have been on a stable dose of dmard therapy for at least 28 days prior to enrollment * had a negative pregnancy test (females) * was not taking glucocorticoids at screening exclusion criteria: * female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). female subjects using hormonal birth control are not to be enrolled. * subject is currently taking any steroids (glucocorticoids). all glucocorticoids must be discontinued for at least one month prior to entering study. intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study. * subject is currently taking more than 81 mg of aspirin daily. * subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial. * subject has any active infections or recent surgical procedures within 30 days of study initiation. * subject has uncontrolled diabetes mellitus as defined by a hba1c value ≥ 7.0%. * subject knowingly has hiv or hepatitis. * subject has undergone administration of any investigational drug within 30 days of study initiation. * subject has a history of hypersensitivity to steroids and/or dipyridamole. * subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.

Keywords: rheumatoid arthritis ra dmard crp
brain network activation analysis to diagnose/assess treatment of unipolar major depression and bipolar i depression

Conditions: Depression

Summary: the investigators are conducting this study to test the usefulness of a new type of analysis of electroencephalographic (eeg) recordings called brain network activation or bna. bna allows to identify patterns of activation in brain networks and to track their changes over time. the investigators want to examine the possible role of brain network activation (bna) in the diagnosis of mood disorders and predicting improvement over time. the procedure conducted with patients diagnosed with a mood disorder will be compared to people who do not have a mood disorder.

novel approach to ascertain use of bna strategy and technology for the use in confirming diagnosis and predicting effect of specific treatment(s)in the various stages of affective/mood disorders. the goal is to develop non-invasive technology to confirm diagnosis via biological outcomes, and to study the preliminary data of predicting response/non-response to specific interventions before clinical effects are shown.

Eligibility criteria:
only subjects participating in another specific clinical trial will be invited to participate in this study. the inclusion/exclusion criteria for this observational study are based on the individual inclusion/exclusion criteria for each of the studies and can be found for each of the studies on this website. the specific studies and their numbers are found on their individual clinicaltrials.gov site. inclusion criteria: bipolar i, depressed major depression meeting all criteria to sign the informed consent for each study included in this study who currently have a major depression (unipolar or bipolari) exclusion criteria: medically unstable (based on opinion of sponsor and pi unable to meet the criteria to conform to the rush university informed consent process
effect of 4 weeks treatment with acipimox in patients with chronic heart failure

Conditions: Heart Failure

Summary: the primary objective of this study is to evaluate whether metabolic modulation improves left ventricular function, work capacity, insulin sensitivity and modifies substrate metabolism in chronic heart failure


Eligibility criteria:
inclusion criteria: * ef\<40 % * ihd * nyha-class ii-iii. exclusion criteria: * pregnancy * severe renal failure * new brady- or tachyarrhythmia * severe stenotic valvular disease * myocardial infarction within last 6 weeks * insulin treated diabetes mellitus * peptic ulcer * pregnancy or lactating women * allergy towards tested medicine

Keywords: heart failure
retrospective evaluation of the clinical results obtained in patients with acute lymphoblastic leukemia treated at the san giovanni battista hospital.

Conditions: Disease: Acute Lymphoblastic Leukemia

Summary: this study provides for the collection of a series composed by patients with newly diagnosed of acute lymphoblastic leukemia in the period 1999-2011. this collection is carried out with retrospective investigation, through the review of paper and electronic records and data cards in large part already collected as part of study protocols "gimema" or "bfm" or "nilg" approved by the ethics committee of hospital. the purpose of data collection is to check with retrospective predictability of classical risk factors in relation to disease response, and overall survival of the event-free survival, to estimate the cumulative incidence of competitive events such as the emergence of disease, acute and chronic transplant, the transplant-related mortality and relapse of disease.


Eligibility criteria:
patients with newly diagnosed of acute lymphoblastic leukemia enrolled from 1999 to 2011 at the division of hematology, molinette university hospital and candidates for therapeutic approach with curative intent.
preoperative treatment of breast cancer with two different sequential treatment regimens

Conditions: Breast Cancer

Summary: an open-label randomized phase ii study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (t2-t4/n0-2/m0).


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of primary early breast cancer, tumor size greater than or equal to 2 centimeters (cm), of stages t2-t4/n0-2. * performance status 0-2 eastern cooperative oncology group (ecog). * adequate organ function (bone marrow, hepatic, renal, cardiac). exclusion criteria: * prior anthracyclines as part of prior anticancer therapy. * concurrent antitumor therapy. * second primary malignancy. * serious concomitant systemic disorder. * pre-existing sensorial or motor neuropathy * grade 1.
open label study to evaluate long term efficacy, safety and tolerability of repeated dosing in subjects with crohn's disease and who participated and successfully completed m14-115

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in participants with crohn's disease.


Eligibility criteria:
inclusion criteria: - subject successfully enrolled in and completed study m14-115 (nct02185014), including the week 12 ileocolonoscopy. exclusion criteria: * if the week 12 (study m14-115; nct02185014) colonoscopy shows evidence of dysplasia or malignancy. * subject is not in compliance with prior and concomitant medication requirements throughout m14-115 (nct02185014). * subject who developed active tuberculosis (tb) during m14-115 (nct02185014), or subject who is non compliant with prophylaxis for latent tuberculosis (tb) initiated per m14-115 (nct02185014) procedures.

Keywords: crohn's disease
continuation study for latozinemab

Conditions: Neurodegenerative Diseases

Summary: continuation study to provide continued access to latozinemab for participants who have previously participated in a latozinemab study

this is an open-label continuation study to provide access and assess the safety and tolerability of latozinemab in participants who have completed participation in their parent latozinemab study. all participants will receive open-label latozinemab at a dose of 60/mg/kg, every 4 weeks (q4w).

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained and documented (from the participant or, where jurisdictions allow it, from their legal decision maker). * has successfully completed participation in their parent latozinemab study. * female participants must be nonpregnant and nonlactating. * male participants must agree to acceptable contraception use. exclusion criteria: * known history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric, human, or humanized antibodies or fusion proteins. * clinically significant heart disease, liver disease or kidney disease. history or evidence of clinically significant brain disease other than ftd.

Keywords: frontotemporal dementia (ftd) amyotrophic lateral sclerosis (als)
safety and efficacy of linaclotide in patients with chronic constipation and prominent abdominal bloating

Conditions: Chronic Constipation; Constipation

Summary: the purpose of this study is to evaluate the efficacy and safety of linaclotide compared with placebo in patients with chronic constipation (cc) and prominent abdominal bloating. this study includes an up to 3-week screening period and a 2-3 week pretreatment period. patients who are eligible will be randomized to one of two doses of linaclotide or placebo for 12 weeks. this 12-week study will assess the effects of linaclotide on bowel movement frequency, as well as other abdominal and bowel symptoms of cc.


Eligibility criteria:
inclusion criteria: * patient has completed a colonoscopy according to the american gastroenterological association criteria with no clinically significant findings * patient has successfully completed protocol procedures (with no clinically significant findings) * patient meets protocol criteria for chronic constipation(cc): \< 3 bowel movements per week and reports one or more of the following symptoms for at least 12 weeks: 1. straining during more than 25% of bms 2. lumpy or hard stools during more than 25% of bms 3. sensation of incomplete evacuation during more than 25% of bms * patient demonstrates continued chronic constipation and bloating through pretreatment period * patient is compliant with interactive voice response system (ivrs) exclusion criteria: * patient has a history of loose or watery stools * patient has symptoms of or been diagnosed with irritable bowel syndrome (ibs) * patient has a structural abnormality of the gastrointestinal (gi) tract or a disease or condition that can affect gi motility * patient has any protocol-excluded or clinically significant medical or surgical history that would limit the patient's ability to complete or participate in this clinical trial or could confound the study assessments

Keywords: chronic constipation abdominal bloating linaclotide
hypnoanalgesia for dermatological surgery in children

Conditions: Anesthesia

Summary: this randomized clinical trial will evaluate the effect of hypnosedation on the need of sedation and analgesia in a pediatric population undergoing dermatological surgery, both during the procedure, and 24 hours after surgery. in addition, a secondary objetive is to evaluate the effect by specific age groups.

in this clinical trial, pediatric patients scheduled for removal of benign skin lesions in a single center willbe randomised to receive hypnosis (intervention group) or attention-distracting techniques (control group). endpoints will be the sedative dose (propofol) during surgery, and the need for analgesia (paracetamol and others) immediately after surgery (recovery) and after 24 hours. randomization will be systematic in blocks depending on the day the surgery is programmed. hypnosis will be delivered by an experienced anesthesist trained in the technique. patients and families will be informed of the special treatment during surgery, but will be unaware of whether the patients are experiencing distraction or hypnosis techniques. distraction is already a useful technique, and it is expected that patients will be satisfied with the procedure; however, the hypothesis to be tested is that hypnosis reduces the need for sedation and analgesia compared to distraction techniques, as well as improves satisfaction.

Eligibility criteria:
inclusion criteria: 1. a class i or ii of anaesthetic risk according to the american society of anesthesiologists, 2. to be in a percentile between p3 and p97 in weight and height, 3. without known drug allergies, and 4. having fasted 6 hours for solids and 2 hours for water. exclusion criteria: 1. children with diagnosed mental retardation or attention deficit, 2. behavioural disorders, 3. previous treatment with hypnosis, 4. history of neurological pathology or psychomotor retardation, 5. previous pain-related pathology, 6. obstructive sleep apnoea syndrome (osas)

Keywords: analgesia anxiety pain paediatric surgery dermatology hypnosis nervous system diseases central hypnotics and sedatives nervous system depressants physiological effects of drugs
early biomarker kidney injury assessment after acumen directed fluid management in cardiac surgery

Conditions: Renal Injury; Acute Kidney Injury

Summary: this study is to assess the benefits of goal-directed fluid management with acumen in cardiac surgical patients and its impact on cardiac surgery-induced kidney injury.

this study is to assess the benefits of goal-directed fluid management with acumen in cardiac surgical patients undergoing a cabg, avr, or cabg/avr. kidney injury biomarkers ngal, uromodulin, and hepcidin-25 will be used to assess cardiac-induced kidney injury. patients will be randomly enrolled in either standard care for fluid management or goal-directed fluid management with acumen.

Eligibility criteria:
inclusion criteria: * adult patients undergoing cardiopulmonary bypass * procedure coronary artery bypass grafting, aortic valve replacement, or both exclusion criteria: * patients \< 18 years old * emergent surgery * preoperative kidney disease (cr \> 2.0 or on renal replacement therapy) * ejection fraction \< 40% * incomplete data in medical record

Keywords: cardiac surgery cardiac surgery induced kidney injury kidney biomarkers
asthma exacerbation and helium-3 mri

Conditions: Asthma Exacerbation

Summary: the goal of this research is to use helium-3 mri to see the changes in airflow of the lungs at different times of an attack. these three stages are immediately after the attack, 1 month later and 4-6 months later.

asthma is a pulmonary disorder that affects millions of people each year. the exact method of exacerbation is still under some discussion. currently there is no cure for the disorder but treatment is of a wide variety. this study is meant to image the asthmatic lung at various time points post exacerbation. since pulmonary imaging is currently limited to radiation techniques, this method will allow exacerbated images without the unnecessary exposure to radiation.

Eligibility criteria:
inclusion criteria * at least 18 years old * able to speak and read english * acute asthma exacerbation, defined as requirement for hospitalization or emergent outpatient visit, and treatment with high dose corticosteroids ( 40mg prednisone or equivalent) * fev1 \< 80% predicted on the day of mri * attending physician agrees that patient is safe to participate on the day of the mri scan exclusion criteria * evidence of pneumonia, based on chest radiograph obtained within 24 hours of enrollment (if performed) * documented fever or requirement for antibiotics * unable to hold breath for 10 seconds * active smoker or history of at least 10 pack years cigarette smoking * chest radiograph with active pulmonary disease, except for changes expected with asthma (hyperinflation, subsegmental atelectasis) * admission to icu * for inpatients: contraindication to leaving hospital room for mri as determined by attending physician and rn on day of mri * any other concurrent active pulmonary disease or other unstable or active medical condition (including suspected active coronary ischemia, acute bleeding), as determined by attending physician * pregnancy as self reported * need for cardiac monitoring * need supplemental oxygen at an amount of 4l/min or a facemask

Keywords: asthma exacerbation helium mri lung imaging