bioihbjkbjnl/mcl2 huggingface dataset:
Irinotecan, Carboplatin and Radiation Therapy Followed by Bevacizumab in Limited Stage Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Irinotecan; Carboplatin; Bevacizumab; Radiation
Intervention description: 50mg/m2 days 1 & 8 each 21-day cycle 1 & 2, 28-day cycle 3 & 4; AUC 5; 10mg/kg IV every 2 weeks for 10 doses starting week 16
Intervention MeSH terms: Bevacizumab; Carboplatin; Irinotecan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial
      treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with
      bevacizumab, in patients with limited stage small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

        To be included in this study, you must meet the following criteria:

          -  Small cell lung cancer, confirmed by biopsy.

          -  Limited stage disease after standard evaluation.

          -  Able to perform activities of daily living without assistance.

          -  No previous treatment with chemotherapy, radiation therapy, or biologics.

          -  Measurable or evaluable disease

          -  Adequate bone marrow, liver and kidney function

          -  Able to understand the nature of this study and give written consent.

        Exclusion Criteria:

        You cannot participate in this study if any of the following apply to you:

          -  Age < 18 years

          -  History of previous malignancies

          -  Women pregnant or lactating

          -  History or physical exam evidence of central nervous system disease)

          -  Active infection requiring intravenous antibiotics

          -  Full-dose anticoagulation or thrombolytic therapy within 10 days

          -  Proteinuria.

          -  Serious nonhealing wound, ulcer, or bone fracture

          -  Evidence if bleeding diathesis or coagulopathy

          -  History of heart attack within 6 months.

          -  Uncontrolled cardiovascular disease

          -  PEG or G-tube

          -  History of other serious disease

        Please note: There are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have.
Phase 2 Study of Belimumab Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus (SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: Belimumab 100 mg SC; Belimumab 100 mg SC
Intervention description: Belimumab 100 mg SC for 1 injection on Days 0, 7, 14, and then every two weeks.; Belimumab 100mg SC for 2 injections (of 100mg each) on Days 0, 2, and 4, then 100 mg (1 injection) three times per week.
Intervention MeSH terms: Belimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: SLE; Lupus; Systemic Lupus Erythematosus; Antibodies; Autoimmune Diseases; Belimumab

Summary:

      The purpose of this study is to test the safety and tolerability of repeated subcutaneous
      (SC) doses of belimumab in subjects with SLE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria

          -  Active SLE disease

          -  On stable SLE treatment regimen

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Have received treatment with an B cell targeted therapy

          -  Have received treatment with a biologic investigational agent in the past year

          -  Have received intravenous (IV) cyclophosphamide within 180 days of Day 0

          -  Have severe lupus kidney disease

          -  Have active central nervous system (CNS) lupus

          -  Have required management of acute or chronic infections with the past 60 days

          -  Have current drug or alcohol abuse or dependence or within the past year

          -  Have a historically positive test or test positive at screening for human
             immunodeficiency virus (HIV), hepatitis B, or hepatitis C

          -  Have a history of an allergic or anaphylactic reaction to drugs, food, or insects
             requiring medical intervention
A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-121; TEZ; VX-561; TEZ/IVA; IVA; Placebo
Intervention description: Tablets for oral administration.; TEZ tablet for oral administration.; Tablets for oral administration.; Fixed-dose combination tablets for oral administration.; Tablets for oral administration.; Placebos matched to VX-121, TEZ, and VX-561 for oral administration.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety, tolerability and efficacy of VX-121
      combination therapy in subjects with cystic fibrosis (CF).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Part 1: Heterozygous for F508del and an MF mutation (F/MF)

          -  Part 2: Homozygous for F508del (F/F)

          -  FEV1 value ≥40% and ≤90% of the predicted mean for age, sex, and height

        Key Exclusion Criteria:

          -  History of clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  History of solid organ or hematological transplantation

        Other protocol-defined Inclusion/Exclusion criteria may apply
Development of Positive Psychotherapy for Smoking Cessation
Condition: Smoking
Intervention: Positive Psychotherapy for smoking cessation; Nicotine polacrilex; Relaxation training; Behavioral smoking cessation treatment
Intervention description: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.; 8 weeks of nicotine patch; Instructions in progressive muscle relaxation; Counseling on techniques to manage triggers and avoid smoking
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: smoking cessation

Summary:

      The primary objective of this study is to test a manualized adaptation of positive
      psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a
      preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and
      efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation
      treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will
      include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b
      research will provide the foundation for a future application to conduct a large-scale, Stage
      II, randomized clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smoke at least 5 cigarettes per day for longer than one year with no other ongoing
             tobacco product use

          -  willing to use the transdermal nicotine patch

          -  report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking.

        Exclusion Criteria:

          -  are currently experiencing psychotic symptoms, affective disorder (major depression,
             dysthymia, or mania) or substance use disorder (other than nicotine dependence)

          -  taking prescribed psychotropic medication or receiving other forms of psychotherapy

          -  concomitantly using other pharmacotherapies for smoking cessation

          -  have any contraindications for use of the transdermal nicotine patch.
Study of Phosphate Levels in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: 1.25 g PA21 (250 mg iron); 5.0 g PA21 (1,000 mg iron); 7.5 g PA21 (1,500 mg iron); 10.0 g PA21 (2,000 mg iron); 12.5 g PA21 (2,500 mg iron); Sevelamer hydrochloride
Intervention description: Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.; Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).; Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).; Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).; Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).; Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).
Intervention MeSH terms: Iron; Sevelamer
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 154.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis

Summary:

      The purpose of this study is to investigate the ability of different doses of PA21 to lower
      serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  ≥ 18 years of age,

          -  Receiving stable maintenance hemodialysis 3 times a week

          -  On restricted phosphate diet at screening and throughout study

          -  Receiving stable dose of phosphate binder for at least 1 month

          -  Serum phosphate levels >1.78 mmol/L

        Main Exclusion Criteria:

          -  Uncontrolled hyperphosphatemia

          -  Hypercalcemia at screening or during washout

          -  Serum calcium < 1.9 mmol/L (<7.6 mg/dL)

          -  Severe hyperparathyroidism (iPTH levels >600 ng/L)

          -  Pregnancy or lactation

          -  Iron deficiency anemia

          -  History of hemochromatosis or ferritin >800 mg/L,

          -  Hepatitis B, hepatitis C or other significant concurrent liver disorders

          -  Known positivity to HIV

          -  Use of oral iron preparations 1 month before screening,

          -  Serious medical condition or uncontrolled systemic disease
A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44
Condition: Subjects Referred to CT-examination of the Abdomen
Intervention: Lumentin® 44; Diluted Omnipaque®; Movprep®
Intervention description: Contrast agent; Contrast agent; Contrast agent
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to
      either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in
      contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining)
      will be compared by the three contrast agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender at least 18 years at the time of signing the informed
             consent.

          -  Having a clinical indication for CT-examination of the abdomen

        Exclusion Criteria:

          -  IV administration of iodine is contraindicated

          -  Known allergy to egg albumen

          -  Clinical suspicion, according to medical record, of fistula formation and/or leakage

          -  Referral indication of small bowel disease(s)

          -  Having known manifest thyrotoxicosis

          -  Having known phenylketonuria

          -  Having known Glucose-6-phosphatase deficiency
CAP-Ketamine for Antidepressant Resistant PTSD
Condition: PTSD; Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Intervention: Ketamine; Placebo/Saline
Intervention description: FDA approved anesthetic medication with rapid acting antidepressant effects.; This is a saline placebo/non-active solution.
Intervention MeSH terms: Ketamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PTSD; Ketamine; Veteran; Military; Clinical Trial

Summary:

      The purpose of this study is to test the safety and efficacy of repeated doses of ketamine as
      compared to placebo, in reducing symptoms of Posttraumatic Stress Disorder (PTSD) in an
      active duty military and Veteran population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  male or female Veterans or active duty military personnel between the ages of 18 and
             70 years

          -  diagnosis of PTSD

          -  history of trialing one or more antidepressant medications with little to no PTSD
             symptom improvement

          -  ability to provide written informed consent

        Exclusion Criteria:

          -  females who are currently pregnant or breastfeeding

          -  current high risk for suicide

          -  history of severe head injury
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
Condition: Crohn's Disease
MeSH terms: Crohn Disease; Recurrence
Intervention: Fecal Microbiota Transplant (FMT)
Intervention description: Fecal Microbiota Transplant (FMT)
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention; Recurrence; Fecal Microbiota Therapy

Summary:

      The objective of this trial is to assess if Fecal Microbiota Therapy (FMT) can reduce the
      risk of endoscopic recurrence of Crohn's disease (CD) in patients after intestinal resection.
      The specific outcomes of FMT to be examined are: 1) endoscopic appearance, 2) clinical
      symptoms, 3) safety and tolerability, and 4) microbial diversity. The research team
      hypothesizes that FMT will prevent establishment of "pro-inflammatory" microbiome after
      surgery, leading to a reduced probability of recurrence of macroscopic inflammation. It is
      also hypothesized that FMT will be safe and well-tolerated in these patients.
    

Eligibility criteria:

        Inclusion Criteria (Patients):

          -  Adults (age > 18)

          -  Confirmed diagnosis of Crohn's disease (CD), based on endoscopy, histology and imaging
             (confirmed by Study PI for each site)

          -  Ileo-cecal resection or terminal ileal resection for CD within 30 days prior to
             enrollment

          -  Resection margins & anastomosis free of active inflammation based on histology and
             surgical description (confirmed by Study PI for each site)

          -  No therapy to prevent post-operative recurrence of CD. A 30-day wash-out period for
             anti- tumor necrosis factors (TNF)s, thiopurines, antibiotics will be required prior
             to enrollment.

        Exclusion Criteria (Patients):

          -  Diagnosis of indeterminate colitis

          -  Women who are pregnant or nursing

          -  Patients who are unable to give informed consent

          -  Patients who are unable or unwilling to undergo colonoscopy with moderate sedation
             (>ASA class II)

          -  Patients who have previously undergone FMT

          -  Patients who have a confirmed malignancy or cancer

          -  Participation in a clinical trial in the preceding 30 days or simultaneously during
             this trial

          -  Probiotic use within 30 days of start date

          -  Decompensated cirrhosis

          -  Congenital or acquired immunodeficiencies

          -  Chronic kidney disease as defined by a GFR <60mL/min/1.73m2 44

          -  History of rheumatic heart disease, endocarditis, or valvular disease due to risk of
             bacteremia from colonoscopy
A Clinical Trial to Compare Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg
Condition: Advanced Breast Cancer; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Fulvestrant
Intervention description: 250 intramuscular injection; 500 mg intramuscular injection
Intervention MeSH terms: Fulvestrant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 143.0
Sex: Female
Healthy volunteers: No
Keywords: oncology; cancer; breast cancer

Summary:

      This study will assess the relationship between fulvestrant dose and efficacy, and determine
      the dosing regimen as a second line therapy for Japanese postmenopausal women with oestrogen
      receptor positive advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast Cancer has continued to grow after having received treatment with an
             anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor

          -  Requiring hormonal treatment

          -  Postmenopausal women defined as a woman who has stopped having menstrual periods

        Exclusion Criteria:

          -  Treatment with more than one previous regimen of systemic anticancer therapy other
             than endocrine therapy for advanced breast cancer

          -  Treatment with more than one previous regimen of endocrine therapy for advanced breast
             cancer

          -  An existing serious disease, illness, or condition that will prevent participation or
             compliance with study procedures
Rapamycin for Immunosuppression and B Cell Modulation Post Stem Cell Transplant for Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: RAPAMYCIN
Intervention description: Rapamycin (RAPA, RapamuneR) (sirolimus) is an immunosuppressive agent that was approved by the FDA in 1999. It is a macrocyclic lactone that is structurally similar to Tacrolimus (FK506) and binds to the same intracellular protein as FK506, FKBP1,2,3, but it has an entirely different mechanism of action and a different principal target protein. The target of the RAPA: FKBP complex is the mammalian target of rapamycin (mTOR). Unlike the calcineurin inhibitors cyclosporine (CSA) and - FK506, RAPA exerts its effects by inhibiting growth factor-driven transduction signals in the T-cell response to alloantigen, thus preventing proliferation among T and B lymphocytes3,4.
Intervention MeSH terms: Sirolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 63.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: ALL; Cancer; Stem Cell Transplant

Summary:

      Objectives:

      Primary objective: Evaluate toxicity of rapamycin when used for post-bone marrow transplant
      graft vs. host disease prophylaxis in children with acute lymphoblastic leukemia (ALL).

      Investigator initiated; four participating institutions; Phase II pilot study
    

Eligibility criteria:

        Inclusion Criteria:

          1. Pediatric patients' ages (0 - 21 years) with lymphoid malignancies considered for
             allogeneic bone marrow transplant from HLA-identical sibling donor, single antigen
             mismatched related or unrelated donor marrow /peripheral blood stem cell (PBSC) or
             cord blood available for marrow donation.

             First remission:

               -  if remission not achieved by day28

               -  high risk cytogenetic features, including t(9;22) or t(4;11) Second or third
                  remission

          2. Signed informed consent.

        Exclusion Criteria:

        1. Organ criteria:

          1. Cardiac: ECHO shortening fraction <27%

          2. Renal: Creatinine clearance <60 ml/min/1.73 m2

          3. Hepatic: Bilirubin >1.5 mg/dl, transaminases <3x normal

          4. Infection: active viral, fungal or bacterial infection including HIV.