Kornimate/medical-research-clean huggingface dataset:
a phase 2 safety and efficacy study of incb050465 in subjects with relapsed or refractory diffuse large b-cell lymphoma (citadel-202)

Conditions: Lymphoma

Summary: the purpose of this study is to assess the safety and efficacy of parsaclisib in subjects with relapsed or refractory diffuse large b-cell lymphoma.


Eligibility criteria:
inclusion criteria: * eligible 19 years and older in south korea * relapsed or refractory dlbcl, which has been histologically documented, defined as having received at least 2 but no more than 5 prior treatment regimens and ineligible for high-dose chemotherapy supported by autologous stem cell transplant. * must have ≥ 1 measurable lesion (≥2 cm in longest dimension) or ≥ 1 measurable extranodal lesion (≥1 cm in longest dimension) on computed tomography (ct) scan or magnetic resonance imaging (mri). * subjects must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy. * eastern cooperative oncology group performance status 0 to 2. exclusion criteria: * primary mediastinal (thymic) large b-cell lymphoma. * known brain or central nervous system metastases or history of uncontrolled seizures. * allogeneic stem cell transplant within the last 6 months, or active graft versus host disease following allogeneic transplant, or autologous stem cell transplant within the last 3 months. * use or expected use during the study of any prohibited medications, including potent cytochrome p450 3a4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study drug. * prior treatment with the following: * group a: prior treatment with a selective phosphatidylinositol 3-kinase (pi3k) δ inhibitor (eg, idelalisib), a pan-pi3k inhibitor, or a btk inhibitor (eg, ibrutinib). * group b: prior treatment with a selective pi3kδ inhibitor (eg, idelalisib) or a pan pi3k inhibitor.

Keywords: diffuse large b-cell lymphoma relapsed refractory non-hodgkin lymphoma phosphatidylinositol 3-kinase δ (pi3kδ) inhibitor bruton's tyrosine kinase (btk)
a blinded study to evaluate effect on atrial fibrillation burden in patients with paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation

Summary: the purpose of this study is to evaluate the effect of bms-919373 on atrial fibrillation (af) through its effect on af burden (afb), or the percent of time in af, in subjects with paroxysmal af (paf) when administered orally at a range of doses (2 mg once daily (qd), 5 mg qd, 12 mg qd following a 1-week period of loading doses of 3 mg qd, 8 mg qd and 20 mg qd, respectively) for a total of 4 weeks. it is hypothesized that treatment with bms-919373 will reduce af burden as compared to baseline relative to placebo.

primary purpose: protocol designed to assess, by the use of long term non-invasive beat-to-beat monitoring with the seeq mobile cardiac telemetry (mct) system, the effect of bms-919373 on the percent change from baseline relative to placebo of atrial fibrillation burden in subjects with paroxysmal atrial fibrillation.

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * signed informed consent * paroxysmal atrial fibrillation (paf) with available documentation of af and reporting symptoms within 6 months prior to screening * able to tolerate withdrawal of antiarrhythmic therapy (rhythm control) * echocardiographically measured left ventricular ejection fraction (lvef) ≥40%,measured within 12 months of enrollment * echocardiographically measured left atrial (la) diameter ≤ 5.0 cm, measured within 12 months of enrollment exclusion criteria: * women of childbearing potential * afb \ 70%, during both screening periods independently * permanent or persistent atrial fibrillation * cardioversion within 3 months of study drug administration * stroke within 12 months of study drug administration * tia within 12 months of study drug administration * heart failure of nyha class iii or greater (symptoms of heart failure at rest or with minimal exertion) * heart failure of nyha class ii (symptoms of heart failure with routine levels of exertion)with ejection fraction \<40% as measured by echocardiography at any time within 12 months of study enrollment (i.e. additional ejection fraction measurements ≥ 40% over this period will not counter this exclusion) * valvular heart disease (including any valvular insufficiency or stenosis greater than"mild") * ablation within 3 months of study enrollment
suramin in treating patients with recurrent bladder cancer

Conditions: Bladder Cancer

Summary: rationale: suramin may stop the growth of bladder cancer by stopping blood flow to the tumor. purpose: phase i trial to study the effectiveness of suramin in treating patients who have recurrent bladder cancer.

objectives: * determine the maximum tolerated dose (mtd) of suramin in patients with recurrent superficial bladder cancer. * confirm that there is no significant systemic absorption of this drug when administered intravesically in these patients. outline: this is a dose escalation study. at approximately 14-18 days after surgical resection of bladder tumor(s), patients receive intravesicular suramin via urethral catheter installation into the bladder over 2 hours weekly for 6 weeks in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of suramin until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which 2 of 6 patients develop dose-limiting toxicity. patients are followed at 2-4 weeks. projected accrual: a total of 12-15 patients will be accrued for this study over 1 year.

Eligibility criteria:
disease characteristics: * histologically proven recurrent superficial bladder cancer * intermediate prognosis as defined by the following: * recurrent, multiple ta, t1 carcinoma * multiple (1-7) tumors * tumors resected previously must be histological grade g1 or g2 or * previously treated superficial bladder cancer requiring followup cystoscopy * recurrent disease diagnosed at surgery * no tumor invasion into muscle or carcinoma in situ patient characteristics: age: * 18 and over performance status: * who 0-2 life expectancy: * not specified hematopoietic: * wbc at least 3,500/mm3 * platelet count at least 150,000/mm3 hepatic: * no clinically significant hepatic disease renal: * creatinine clearance greater than 60 ml/min other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study * no history of adrenal insufficiency * no other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or nonmelanoma skin cancer * no history of difficult catheterization * no confusion or disorientation * no other condition that would preclude study compliance prior concurrent therapy: biologic therapy: * no concurrent biologic therapy chemotherapy: * no concurrent chemotherapy endocrine therapy: * no concurrent corticosteroids radiotherapy: * no prior radiotherapy to the bladder * no concurrent radiotherapy surgery: * see disease characteristics * at least 4 weeks since prior major thoracic or abdominal surgery other: * recovered from prior therapy and stable for 4 weeks * at least 6 weeks since prior intravesicular therapy * no prior or concurrent investigational drugs * no concurrent anticoagulants

Keywords: stage 0 bladder cancer stage i bladder cancer recurrent bladder cancer
the effects of c-type natriuretic peptide on human forearm blood vessels

Conditions: Ischaemia-reperfusion (IR) Injury

Summary: to determine the effects of whether increasing cnp concentrations slightly above normal will improve the functioning of blood vessels after the interruption in the flow of blood. in this study we are looking at the function of the blood vessels of the forearm, as a substitute for those in the heart


Eligibility criteria:
inclusion criteria: * healthy human volunteers on no systemic medication, excepting the oral contraceptive pill exclusion criteria: * history of medical illness * unwillingness to sign consent form * use of non-ocp medications * hypertension on examination of the blood pressure
study of medication and placebo response in major depression

Conditions: Depressive Disorder, Major

Summary: the primary purpose of the research study is to use recordings of brain electrical activity (through electroencephalogram, or eeg) and symptom measurements to determine whether patients are likely to show a response to medication or placebo treatment during a treatment trial for depression.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of unipolar major depression exclusion criteria: * substance abuse, psychotic disorder, history of severe head trauma

Keywords: depression eeg qeeg cordance zoloft sertraline placebo electroencephalogram brain antidepressants
study of oral lbh589 in adult participants with refractory/resistant cutaneous t-cell lymphoma (ctcl)

Conditions: Cutaneous T-Cell Lymphoma

Summary: this study evaluated the safety and efficacy of lbh589b in adult participants with refractory/resistant cutaneous t-cell lymphoma and prior histone deacetylase (hdac) inhibitor therapy.


Eligibility criteria:
inclusion criteria: 1. written informed consent obtained prior to any screening procedures 2. age greater than or equal to 18 years old 3. participants with biopsy-confirmed stages ib-iva mycosis fungoides or sézary syndrome (ss). participants with ss who have bone marrow involvement are also eligible. participants with transformed ctcl are eligible 4. participants must have been treated with an hdac inhibitor given for the treatment of ctcl. participants must have had disease progression on or following treatment with an hdac inhibitor. participants are also eligible if they had an inadequate response to an hdac inhibitor defined as stable disease as the best response after at least 3 months of therapy. participants previously treated with an hdac inhibitor are also eligible if they experienced intolerance due to adverse events. 5. baseline multiple-gated acquisition scan (muga) or echocardiogram must have demonstrated left ventricular ejection fraction (lvef) ≥ the lower limit of the institutional normal 6. ecog performance status ≤ 2 exclusion criteria: 1. participants with a history of visceral disease including central nervous system (cns) involvement (i.e. stage ivb ctcl). note, participants who have ss with bone marrow involvement are eligible 2. impaired cardiac function 3. concomitant use of drugs with a risk of causing torsades de pointes 4. participants who have received chemotherapy or any investigational drug or undergone major surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such therapy 5. less than 3 months since prior electron beam therapy 6. women who are pregnant or breast feeding, or women of childbearing potential (wocbp) not willing to use a double method of contraception during the study and 3 months after the end of treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: cutaneous t-cell lymphoma adults mycosis fungoides sézary syndrome ctcl
tolerance and resistance to ibrutinib in patients with chronic lymphocytic leukemia (cll

Conditions: B Cell Chronic Lymphocytic Leukemia

Summary: assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib this project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of btk mutations and plcg2 in the absence of clinical or biological criteria for scalability.

observationnal and biological study

Eligibility criteria:
inclusion criteria: * patients included in the atu (epidemiology) * under treatment at 3 years of ibrutinib * more than 18 years old exclusion criteria: * no ibrutinib treatment
protein intake and exercise-induced muscle damage

Conditions: Sarcopenia

Summary: the goal of this clinical trial is to test the effect of different protein-enhancement strategies versus carbohydrate control on exercise-induced muscle damage in physically active older adults. the main question it aims to answer is: what is the effect of three different protein-enhancement strategies (whey protein (wp), mixed plant-based protein (mpp), and use of protein-rich food products (pfp) on exercise-induced muscle damage in older adults compared to isocaloric carbohydrate control? participants will: * use a protein-enhancement strategy (wp, mpp or pfp) or carbohydrate control for a total of 5 weeks; * participate in a single walking bound (30/40/50 km) two weeks after the start of the study; * participate in a consecutive walking bound (4 days of 30/40/50 km) in the last week of the study period; * complete different questionnaires and give blood samples to test for muscle damage.


Eligibility criteria:
inclusion criteria: * 60 years or older * registered for the nijmegen four days marches (i.e., able to walk 30-50 km/day) * a habitual protein intake \<1.0 g/kg/d based on the protein 55+ (pro55+) screening tool * able to understand and perform the study procedures * able to use a mobile device exclusion criteria: * allergic or sensitive for milk proteins, or lactose intolerant * diagnosed type i or type ii diabetes mellitus * diagnosed intestinal diseases influencing the uptake of protein (i.e., active inflammatory bowel disease, crohn's disease) * consumption of other freely available protein supplements during the study period. * if the subject intends to perform additional exercise bouts that cause muscle damage in the 4 days before the single- and multiple exercise bouts.

Keywords: protein intake muscle damage nutritional intervention supplements e-health
antiviral activity of azd7295 in hcv carriers

Conditions: Hepatitis C

Summary: pk, safety study of azd7295 in hcv carriers


Eligibility criteria:
inclusion criteria: * hcv carrier exclusion criteria: * concurrent medications
role of diet on the microbiome of the digestive system

Conditions: Colorectal Carcinoma

Summary: this study is to learn more about how diet affects the microbiome (bacteria and microorganisms) of the digestive system. researchers want to learn if this, in turn, has an effect on if and how people then develop colorectal cancer.

primary objectives: i. to evaluate the differences in dietary patterns among individuals reporting to be vegetarian and omnivorous. ii. to compare the difference in stool microbiome pattern in the above mentioned two groups of individuals. iii. to compare somatic mutations in colorectal epithelial cells in the above mentioned two groups of individuals. secondary objective: i. to identify and characterize an association between diet, the microbiome and its genotoxic effect on the colorectal epithelial cells and predisposition to colorectal carcinogenesis. outline: participants complete dietary questionnaire over 30-60 minutes and undergo collection of stool, blood, and tissue samples for analysis via sequencing and laser dissection.

Eligibility criteria:
inclusion criteria: * group i: patients presenting for a screening colonoscopy * group i: age of 45 and above * group i: strict vegetarian diet, determined by using diet history questionnaire 3.0 national institutes of health (nih) * group i: non smoker * group i: ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood samples * group ii: patients presenting for a screening colonoscopy * group ii: age of 45 and above * group ii: omnivorous diet * group ii: non smoker * group ii: ability to understand and willingness to sign an informed consent form, complete web based dietary assessment and provide stool, colonic mucosa and blood sample exclusion criteria: * • current smokers (nicotine abuse only) * positive family history of colon cancer or colon cancer related syndromes * recent use of antibiotics in 1 month * history of inflammatory bowel disease, and/or radiation enteritis or colitis * pregnant and breastfeeding women * women of child-bearing potential who have positive urine or serum pregnancy test * heavy drinker (defined as more than 14 drinks per week) * currently using anti-flatulence medications, probiotics and/or fiber supplements * major dietary restrictions and/or following a special diet * patient with positive fecal test/symptoms
study evaluating mac-321 in colorectal cancer

Conditions: Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Summary: assess the clinical activity of mac-321 administered iv as a second-line or third-line antineoplastic agent to subjects with advanced colorectal cancer. clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete plus partial responses). tumor response will be assessed following modified response evaluation criteria in solid tumors (recist) guidelines.


Eligibility criteria:
inclusion criteria: * histologic and/or cytologic diagnosis of metastatic or relapsed colorectal cancer at any time during disease but not candidates for surgical resection. * prior treatment with at least 1 conventional approved therapeutic regimen. * subjects who have failed prior cytotoxic chemotherapy regimens containing irinotecan (cpt-11), 5 fluorouracil (5-fu), and/or oxaliplatin for advanced (relapsed) metastatic colon cancer are eligible exclusion criteria: * other chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks before signing the icf (6 weeks if the previous chemotherapy included nitrosoureas or mitomycin) * prior radiotherapy to \>25% of bone marrow * prior exposure to mac-321

Keywords: colorectal cancer colorectal carcinoma colorectal tumors neoplasms, colorectal colorectal neoplasms
study of [14c]cs0159 in china healthy subjects

Conditions: Primary Biliary Cholangitis

Summary: study of \[14c\]cs0159 in china healthy subjects.

a phase i study to quantify the total mass balance in healthy subjects after a single dose of \[14c\]cs0159.

Eligibility criteria:
inclusion criteria: 1. healthy male subjects between the ages of 18 and 45 years (inclusive). 2. subjects should not weigh less than 50 kg, bmi between 19\~26 kg/㎡. 3. no sperm donation or fertility plan during the study and within 12 months after the end of the study. 4. understand the purpose and requirements of trial, subjects who have voluntarily participated in the study and signed the icf, completion of tests as required. exclusion criteria: 1. with abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ecg, chest x-ray, and abdominal ultrasound. 2. 12-ecg qt(qtcf)\>450ms. 3. the history of drug allergy. 4. patients with malabsorption and gastrointestinal disorders or history of vomiting, diarrhoea in the week prior to the screening period. 5. patients with difficulty swallowing or interfere with drug absorption. 6. hbs ag or e antigen, tpab, or hiv-ag/ab positive person. 7. have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period. 8. habitual constipation or diarrhoea. 9. heavy smokers addicts 10. heavy drinker addicts. 11. has drug abuse history or positive drug abuse test results. 12. heavy caffeine addicts. 13. special dietary requirements. 14. poor adherence or any other conditions judged by the investigator as not suitable for the study.
a phase 3 study of a daclatasvir/asunaprevir/bms-791325 fixed dose combination (fdc) in subjects with chronic hepatitis c genotype 1

Conditions: Hepatitis C Virus

Summary: to demonstrate the effectiveness of daclatasvir (dcv) 3 direct acting antivirals (daa) fixed dose combination in genotype 1 chronic hepatitis c subjects.

us national institutes of health division of aids (daids)

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * subject chronically infected with hcv genotype 1 (gt-1) * subject without cirrhosis or with compensated cirrhosis (child pugh class a) * hcv rna ≥ 10,000 iu/ml at screening * treatment-naïve subject with no previous exposure to an interferon formulation (ie, ifnα, pegifnα), ribavirin (rbv), or hcv daa (protease, polymerase inhibitor, etc.) * interferon (ifn) experienced subject who have received previous treatment with ifnα, with or without rbv exclusion criteria: * liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair; * current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening; * documented or suspected hepatocellular carcinoma (hcc), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed); * evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
study of refractory and/or relapsing takayasu arteritis

Conditions: Systemic Vasculitis; Arteritis, Takayasu; Arteritis

Summary: takayasu arteritis (ta) is a vasculitis of unknown origin, resulting in progressive thickening and stenosis of large and medium arteries (the aorta and its major branches, and the pulmonary arteries). first line therapy of ta consists of high dose corticosteroids (cs) (mukhtyar et al, 2009). between 20 and 50% of cases respond to cs alone, with subsequent resolution of symptoms and stabilization of vascular abnormalities (shelhamer et al, 1985; maksimowicz-mckinnon et al, 2007). although second-line agents (methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide) may result in initial remission, relapses remain common when prednisone is tapered (maksimowicz-mckinnon et al, 2007). thus, 50% of cs-resistant or relapsing ta patients may achieve sustained remission with the addition of methotrexate (hoffman et al, 1994). during the last decade, biologics such as anti-tumor necrosis factor alpha (anti-tnfα) and anti-interleukin-6 (anti-il-6) have been used as third-line treatment in refractory or relapsing ta. almost 90% of cs-methotrexate resistant ta cases responded to infliximab, an anti-tnfα, and sustained remission was obtained in 37 to 76% of the cases (schmidt et al, 2012; comarmond et al, 2012; mekinian et al, 2012). tocilizumab, an anti-il-6 has given similar results with 68% of sustained remission in refractory ta (abisror et al, 2013). irrespective of classical cardiovascular risk factors, the systemic inflammation and cs use play a pivotal role in the occurrence of cardiovascular thrombotic events (cves) (roubille et al, 2015). as cves overlap with ta complications it is primordial to drastically taper cs in that vasculitis. we therefore aim to analyses prospectively the long term outcome of refractory/relapsing ta patients.


Eligibility criteria:
inclusion criteria: * diagnosis of takayasu arteritis according to the international criteria of the american college of rheumatology (acr) (arend et al, 1990) and/or ishikawa criteria modified by sharma. * active disease according to the international criteria of the national institute of health (nih) (kerr et al, 1994) * able and willing to give informed consent and comply with the requirements of the study protocol exclusion criteria: * aortitis of other cause (i.e. infectious, anca vasculitis, histiocytosis, cancer..) * lack of affiliation to a social security benefit plan (as a beneficiary or assignee)