bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Oral BT-11 in Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: BT-11 (440 mg); BT-11 (880 mg); Placebo
Intervention description: Oral, once daily tablet; Oral, once daily tablet; Oral, once daily tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter study with an optional open label extension (OLE) period. The purpose of this study is to evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This study includes 3 periods: induction, maintenance, and an optional OLE period.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 198.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a phase 2 randomized, placebo-controlled, double-blind, parallel-group multicenter
      study with an optional open-label extension (OLE) period. The purpose of this study is to
      evaluate the efficacy and safety of oral BT-11 compared to placebo in subjects with UC. This
      study includes 3 periods: induction, maintenance, and an optional OLE period.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. . Male and female subjects aged 18 to 75 years, inclusive.

          2. . Diagnosis of UC for at least 3 months prior to screening.

          3. . UC, as defined by a total Mayo Score of 4 to 10 inclusive at baseline with a MES 2
             (confirmed by central reader).

          4. . Able to participate fully in all aspects of this clinical trial.

          5. . Written informed consent must be obtained and documented.

        Key Exclusion Criteria:

          1. . A diagnosis of CD, indeterminate colitis, or presence or history of the fistula with
             CD.

          2. . Modified Truelove and Witts criteria (2: 6 bloody stools per day and one or more of
             the following: pulse > 90 bpm, temperature > 37.8°C, hemoglobin < 10.5 g/dl, or hs-CRP
             > 30 mg/I).

          3. . Disease activity limited to distal 15 cm (proctitis).

          4. . Treatment with an immunosuppressant (azathioprine, 6- mercaptopurine [6-MP]) within
             25 days prior to randomization.

          5. . Unable to attend study visits or comply with procedures.

          6. . Concurrent participation in any other interventional study.

          7. . Prior enrollment in the current study and had received study treatment.
Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery
Condition: Acute Kidney Injury; Congenital Heart Disease
MeSH terms: Acute Kidney Injury; Heart Diseases; Heart Defects, Congenital; Wounds and Injuries
Intervention: Sodium Bicarbonate; Sodium Chloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Pediatric; Sodium bicarbonate; Acute kidney injury; Cardiac surgery

Summary:

      The proposed study will investigate the effect of sodium bicarbonate on the prevention of
      acute kidney injury in children undergoing cardiac surgery with cardio-pulmonary bypass. The
      investigators hypothesize that the occurrence of acute kidney injury will be less in children
      treated with sodium bicarbonate in the perioperative period when compared to placebo. The
      specific aims of this proposal are as follows:

      1. To institute a prospective, randomized, double-blinded, placebo-controlled trial in
      pediatric subjects undergoing cardiac surgery to determine the efficacy of sodium bicarbonate
      on prevention of acute kidney injury as measured by pRIFLE criteria. 2. To examine whether
      treatment with sodium bicarbonate modifies the duration of acute kidney injury, fluid
      balance, hospital length of stay, need for dialysis, and progression to kidney failure. 3. To
      determine the relevance of NGAL as a biomarker to predict development of acute kidney injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects age ≤18 years

          2. Subjects scheduled for cardiac surgery with cardiopulmonary bypass

        Exclusion Criteria:

          1. Subjects with abnormal creatinine clearance (<90 ml/min/1.7m2) as measured by the
             Schwartz formula

          2. Subjects with known cystic kidney disease or posterior ureteral valves (subjects with
             solitary kidney, single multicystic/dysplastic kidney, hydronephrosis will not be
             excluded if renal function is preserved)

          3. Subjects with known metabolic disorder

          4. Premature infants born <30 weeks gestation and <30 days old due to risk of
             intraventricular hemorrhage

        Subjects in severe cardiogenic shock post-operative requiring extra-corporeal membrane
        oxygenation (ECMO) or left ventricular assist device (LVAD) will be withdrawn from the
        study.
A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment
Condition: Infertility
MeSH terms: Infertility
Intervention: FE 999049; Gonal - F
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 265.0
Sex: Female
Minimum age: 18 Years
Maximum age: 37 Years
Healthy volunteers: No

Summary:

      This trial investigates the effects of several doses of FE 999049 in women undergoing
      IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women diagnosed with tubal infertility, unexplained infertility, infertility related
             to endometriosis stage I/II or with partners diagnosed with male factor infertility

          -  Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm
             injection) treatment

          -  Women aged 18-37 years

          -  Women with body mass index (BMI) of 18.5-32.0 kg/m2

        Exclusion Criteria:

          -  Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis
             stage III/IV

          -  Women with history of recurrent miscarriage

          -  Women with contraindications to controlled ovarian stimulation with gonadotropins

          -  Women with three or more controlled ovarian stimulation cycles
Gemcitabine in Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: gemcitabine; cisplatin
Intervention description: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity; 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary endpoint of this study is to assess the objective tumor response rate in patients
      with advanced epithelial ovarian cancer receiving combination of Gemcitabine at a dose 1250
      mg/m2 (Day 1 and 8) with Cisplatin 75 mg/m2 (Day 1) as first-line treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  ECOG = 0-2

          -  Operated patients

          -  disease stage III-IV

        Exclusion Criteria:

          -  No prior chemotherapy or radiation therapy
A Study of MabThera (Rituximab) Plus Chlorambucil in Participants With Chronic Lymphocytic Leukemia.
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Rituximab; Chlorambucil
Intervention description: 375mg/m^2 IV on Day 1 of Cycle 1; 500mg/m^2 on Day 1 of Cycles 2-6.; 10 mg/m^2/day PO on Days 1 to 7 of each cycle for a maximum of 12 cycles.
Intervention MeSH terms: Rituximab; Chlorambucil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the safety and effect on response rate of a combination of
      rituximab and chlorambucil in previously untreated participants with B-cell chronic
      lymphocytic leukemia. Participants will receive 6 monthly cycles of combination treatment,
      followed by up to 6 cycles of chlorambucil alone. Rituximab will be administered on Day 1 of
      each cycle, at a dose of 375 milligrams per square meter (mg/m^2) intravenously (IV) in Cycle
      1, and 500 mg/m^2 in subsequent cycles, and chlorambucil will be administered on Days 1-7 of
      each cycle at a dose of 10 mg/m^2/day per oral (PO).
    

Eligibility criteria:

        Inclusion Criteria:

          -  previously untreated participants with cluster of differentiation 20 (CD20) positive
             B-cell chronic lymphocytic leukemia;

          -  participants with progressive Binet stage B, or C requiring therapy according to
             National Cancer Institute (NCI) criteria;

          -  Eastern Cooperative Oncology Group (ECOG) performance status <=2.

        Exclusion Criteria:

          -  previous treatment for Chronic Lymphocytic Leukaemia (CLL);

          -  known concomitant hematological malignancy;

          -  transformation to aggressive B-cell malignancy;

          -  history of severe cardiac disease;

          -  known hypersensitivity or anaphylactic reactions to murine antibodies.
NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: NKTR-102; irinotecan
Intervention description: IV every 3 weeks; IV every 3 weeks
Intervention MeSH terms: Irinotecan; Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colorectal cancer; Colorectal cancer, second line

Summary:

      This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect
      in patients with colorectal cancer. This study will also evaluate how the safety and
      anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for
      use in the US for treatment of patients with certain types of colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  metastatic colorectal cancer

          -  tumor with k-ras mutation

        Exclusion Criteria:

          -  More than 1 prior regimen for treatment of metastatic disease
A Multicenter Study to Evaluate the Effects of a 91-Day Extended Cycle Oral Contraceptive on Hemostatic Parameters in Healthy Women
Condition: Hemostasis; Oral Contraceptive
Intervention: 91-day Levonorgestrel Oral Contraceptive; 28-day Levonorgestrel Oral Contraceptive; 28-day Desogestrel Oral Contraceptive
Intervention description: 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.; 21 combination tablets containing 150 µg LNG/30 µg EE.; 21 combination tablets containing 150 µg DSG/30 µg EE.
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Desogestrel; Contraceptives, Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 265.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Contraception; Hemostasis; Blood Coagulation

Summary:

      This study is being conducted to evaluate the impact of a 91-day extended cycle oral
      contraceptive compared to two 28-day oral contraceptive regimens on hemostatic parameters in
      healthy women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal, non-pregnant, non-lactating women age 18-40 years old

          -  Body Mass Index (BMI) ≥18 kg/m² and <30 kg/m²

          -  Regular spontaneous menstrual cycle

          -  Others as dictated by FDA-approved protocol

        Exclusion Criteria:

          -  Any condition which contraindicates the use of combination oral contraceptives

          -  Any history of, or active, deep vein thrombosis, pulmonary embolism, or arterial
             thromboembolic disease within one year of screening

          -  Any known genetic component for thrombophilia including Factor V Leiden mutation,
             prothrombin mutation, protein C deficiency, protein S deficience, or antithrombin III
             deficiency

          -  Others as dictated by FDA-approved protocol
Effectiveness of Lofexidine to Prevent Stress-Related Opiate Relapse During Naltrexone Treatment - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: Lofexidine; Placebo
Intervention description: Participants will receive lofexidine. The dosing will be initiation at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject.; Lofexidine Placebo
Intervention MeSH terms: Lofexidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opioid dependence

Summary:

      Lofexidine is an experimental medication that may be beneficial in reducing opiate withdrawal
      symptoms, such as sleep difficulty, anxiety, and tension. The purpose of this study is to
      determine whether lofexidine in combination with naltrexone can improve an individual's
      ability to cope with stress and subsequently increase the chances of remaining abstinent from
      opiates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV criteria for opioid dependence

          -  Eligible to take a daily dose of 50 mg of naltrexone

          -  Normal EKG

          -  Able to read English

        Exclusion Criteria:

          -  Currently psychotic or psychiatrically disabled (e.g., suicidal, homicidal, manic)

          -  Regular use of anticonvulsants, sedatives/hypnotics, prescription analgesics,
             antihypertensives (including clonidine), antiarrhythmics, antiretroviral medications,
             or tricyclic antidepressants

          -  Underlying medical conditions, such as cerebral, kidney, thyroid, or cardiac
             pathology, and currently taking medications for any of these conditions

          -  Abstinent from opiates for more than 4 weeks prior to initiation of naltrexone

          -  Medical problems precluding naltrexone treatment, such as hepato-cellular injury, as
             evidenced by abnormal liver enzyme tests (greater than three times the normal level)
             and a history of cirrhosis

          -  Hypotensive (resting blood pressure below 90/50 mm Hg)

          -  Pregnant or breastfeeding

          -  Use of an investigational drug within the 3 months prior to enrollment
TCRαβ+/CD19+ Depleted Allogeneic Hematopoietic Stem Cell Transplantation for Malignant and Non-malignant Disorders
Condition: Allogeneic Hematopoietic Cell Transplantation
Intervention: TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)
Intervention description: The majority of TCRαβ+ T cells and CD19+ B cells will be removed from the allogeneic graft utilizing the CliniMACS® immunomagnetic selection device (Miltenyi Biotec). The depletion process involves two phases; cell labeling (phase 1) and the automated immunomagnetic depletion process (phase 2). The CD34+ dose may be adjusted by the need to not exceed the TCRαβ+CD3+ dose threshold.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and efficacy of TCRαβ+/CD19+ depleted
      allogeneic hematopoietic stem cell transplant (HSCT) for malignant and non-malignant
      disorders in children and adolescent/young adult patients using the CliniMACS® immunomagnetic
      selection device (Miltenyi Biotec).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Any patient being treated at Cincinnati Children's Hospital requiring an allogeneic
             HSCT who lacks an HLA-genotypically matched related donor. Genotypically matched
             related donors are allowed when there is a clinical desire to avoid the use of GVHD
             prophylaxis medications.

        Exclusion Criteria:

          -  Prior allogeneic transplant with active acute or chronic GVHD, or life-threatening
             infection. Patients with a prior history of allogenic transplant without active GVHD
             or life-threatening infection can be considered.
High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: BeEAM
Intervention description: BeEAM
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Multiple myeloma; hematopoietic stem cell transplant

Summary:

      High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the
      up-front treatment of patients with multiple myeloma has been associated with improved
      disease-free and overall survival in multiple large randomized controlled trials. Following
      3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose
      Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70
      years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care
      preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing
      Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results
      to single-agent Melphalan with higher toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age between 18 - 70 years

          -  Karnofsky status ≥ 70%

          -  Diagnosis of Multiple Myeloma

          -  Within 9 months of the start of induction chemotherapy and no evidence of relapse or
             progression.

          -  Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least
             2x106/kg.

        Exclusion Criteria:

          -  Poor cardiac function: left ventricular ejection fraction <40%

          -  Poor pulmonary function: FEV1, FVC, or DLCO <40% predicted

          -  Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary
             malignancy), AST/ALT > 3X ULN

          -  Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance < 40 mL/min
             (calculated creatinine clearance is permitted)

          -  Ongoing or active systemic infection, active hepatitis B or C virus infection, or
             known human immunodeficiency virus (HIV) positive.

          -  Women of childbearing potential who currently are pregnant or who are not practicing
             adequate contraception

          -  Patients who have any debilitating medical or psychiatric illness which would preclude
             their giving informed consent or their receiving optimal treatment and follow-up.
A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene
Condition: Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Alirocumab; Placebo
Intervention description: SC injection in the abdomen; SC injection in the abdomen
Intervention MeSH terms: Alirocumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to assess the pharmacodynamic (PD) effect of alirocumab
      on serum low density lipoprotein cholesterol (LDL-C) during 14 weeks of subcutaneous (SC)
      administered alirocumab in patients with autosomal dominant hypercholesterolemia (ADH) and
      gain-of-function mutation (GOFm) in 1 or both alleles of the proprotein convertase
      subtilisin/kexin type 9 (PCSK9) gene or with loss-of-function mutation (LOFm) in 1 or more
      alleles of the apolipoprotein (ApoB) gene.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria include, but are not limited to the following:

          1. Between the ages of 18 and 70 years, inclusive

          2. A history of molecularly confirmed PCSK9 GOFm for cohort 1 and a history of
             molecularly confirmed PCSK9 GOFm or ApoB LOFm

          3. Plasma LDL-Cholesterol levels ≥70 mg/dL at the screening visit on a lipid-lowering
             therapy (LLT) regimen stable for at least 28 days

        Exclusion Criteria:

        Exclusion criteria include, but are not limited to the following:

          1. Serum triglycerides >350 mg/dL at the screening visit

          2. Known to be positive for human immunodeficiency virus (HIV), hepatitis B virus, or
             hepatitis C virus

          3. Pregnant or breast-feeding women.

          4. Sexually active man or woman of childbearing potential who is unwilling to practice
             adequate contraception during the study