bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia
Condition: Aplastic Anemia
MeSH terms: Anemia; Anemia, Aplastic
Intervention: AMG531
Intervention description: Subcutaneous, weekly injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Anemia, Aplastic; Thrombopoietin; Thrombocytopenia

Summary:

      The present study will be conducted to evaluate the efficacy and safety of AMG531 and to
      determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when
      it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with
      immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics
      of this product. Its efficacy and safety during the extension period beyond one year will
      also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient who is diagnosed as AA and refractory to immunosuppressive therapy

          -  Platelet ≤ 30,000/μL

        Exclusion Criteria:

          -  Concurrent active infection not adequately responding to appropriate therapy

          -  HIV positivity

          -  Bone marrow reticulin grade of > 1

          -  Clinically significant cardiac disease

          -  Arterial or venous thrombosis within the last 1 year before enrollment

          -  Other cause of thrombocytopenia

          -  AA with hemolytic predominant paroxysmal nocturnal hemoglobinuria (PNH)

          -  Uncontrolled diabetes

          -  Receiving any agent used to treat AA, including antithymocyte globulin (ATG) or ATG +
             cyclosporine within 6 months before starting study treatment and/or cyclosporine or
             anabolic hormone within 6 weeks before starting the study treatment

          -  History of PEG-rHuMGDF, recombinant human thrombopoietin, AMG531, and other
             thrombopoietin (TPO)-receptor agonist

          -  Who plans to conduct hematopoietic stem cell transplantation within 1 year
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Ichthyosis
Condition: Ichthyosis
MeSH terms: Ichthyosis; Ichthyosis, Lamellar
Intervention: Imsidolimab; placebo
Intervention description: Humanized Monoclonal Antibody; placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 5.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: IL-36 Receptor; Interleukin 36; Imsidolimab

Summary:

      Efficacy and Safety of imsidolimab in Participants with Ichthyosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Ichthyosis

          -  IASI total score ≥ 18, erythema score ≥ 2

          -  Participant has been using emollient daily for at least 1 week prior to Day 1 and
             agrees to continue using that same emollient daily at the same frequency throughout
             the study

        Exclusion Criteria:

          -  A participant with ichthyosis vulgaris, X-linked ichthyosis, or lamellar ichthyosis
             will be excluded.
Dilute Povidone-iodine Irrigation vs No Irrigation for Children With Acute, Perforated Appendicitis
Condition: Acute, Perforated Appendicitis
MeSH terms: Appendicitis
Intervention: Povidone-iodine irrigation; No irrigation
Intervention description: Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.
1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister.; Patients allocated to the control group will not undergo intra-abdominal irrigation.
Intervention MeSH terms: Povidone-Iodine; Povidone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 100.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Povidone-iodine irrigation

Summary:

      The goal of this study is to compare the efficacy of PVI irrigation to no irrigation for
      decreasing postoperative intra-abdominal abscesses in children with perforated appendicitis.
      Additionally, this study aims to verify the safety profile of dilute PVI for intra-abdominal
      irrigation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children who undergo an appendectomy for perforated appendicitis. (Appendicitis:
             Diagnosis is made intraoperatively by the surgeon. Diagnosis Method: The visualization
             of a gross defect in the appendiceal wall or the presence of intraperitoneal stool or
             a fecalith at the time of operation.)

        Exclusion Criteria:

          -  Patients presenting with simple or gangrenous appendicitis

          -  Patients with a history of iodine sensitivity, thyroid disease or renal disease

          -  Patients undergoing interval or incidental appendectomy

          -  Patients/parents/legal guardians who are both non-English and non-Spanish speaking
A Study of Nivolumab Plus Ipilimumab, Ipilimumab Alone, or Cabazitaxel in Men With Metastatic Castration-Resistant Prostate Cancer (CheckMate 650)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Nivolumab; Ipilimumab; Cabazitaxel; Prednisone
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Prednisone; Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 351.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effectiveness, safety and tolerability of
      nivolumab followed by ipilimumab, in subjects with metastatic castration resistant prostate
      cancer (mCRPC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Current evidence of metastatic disease documented by either bone lesions on
             radionuclide bone scan and/or soft tissue lesions on computerized tomography/magnetic
             resonance imaging (CT/MRI).

          -  Ongoing androgen deprivation therapy (ADT) with a Gonadotropin-releasing hormone
             (GnRH) analogue or a surgical/medical castration with testosterone level of
             ≤1.73nmol/L (50ng/dL)

        For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

          -  Previously randomized to Arm D3 or D4; had histologic confirmation of adenocarcinoma
             of the prostate and evidence of Stage IV disease (as defined by American Joint
             Committee of Cancer criteria (AJCC criteria) prior to randomization

        Exclusion Criteria:

          -  Presence of visceral metastases in the liver

          -  Active brain metastases or leptomeningeal metastases

          -  Active, known, or suspected autoimmune disease or infection

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or
             any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
             pathways

        For crossover phase for participants originally randomized to Arm D3 or Arm D4 only:

          -  Prior radiation therapy within 14 days prior to first dose of nivolumab combined with
             ipilimumab

          -  Have received systemic anti-cancer therapy after the last dose of study treatment
             (ipilimumab or cabazitaxel)

        Other protocol-defined inclusion/exclusion criteria apply
High-Dose Cyclophosphamide for Steroid Refractory GVHD
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Cyclophosphamide
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: graft versus host disease

Summary:

      RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute
      graft-versus-host disease that did not respond to steroid therapy.

      PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose
      cyclophosphamide works in treating patients with acute graft-versus-host disease that did not
      respond to steroid therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed acute graft-versus-host disease (GVHD) ≥ clinical grade II,
             that is steroid refractory

               -  Steroid refractory GVHD is defined as GVHD that has progressed (increasing in
                  grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg OR
                  GVHD that has failed to improve (no change in grading stage) despite 4 days of
                  treatment with methylprednisolone of ≥ 2.0 mg/kg

          -  Prior allogeneic hematopoietic stem cell transplantation using either bone marrow,
             peripheral blood stem cells, or cord blood OR prior donor lymphocyte infusion required

          -  Evidence of myeloid engraftment

          -  No chronic GVHD

        PATIENT CHARACTERISTICS:

          -  ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2 OR Karnofsky PS
             60-100%

          -  ANC (absolute neutrophil count) > 500/mm³

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Must be geographically accessible

          -  No allergy or intolerance to cyclophosphamide or mesna

          -  No HIV positivity

          -  No mechanical ventilation

          -  No active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic
             cystitis

          -  No other uncontrolled illness including, but not limited to, the following:

               -  Ongoing or active infection

               -  Medical condition precluding patient from stopping azoles (e.g., fluconazole,
                  itraconazole, or voriconazole) or other adequate antifungal therapy during
                  cyclophosphamide administration

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Psychiatric illness/social situations that would preclude compliance

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics
Xeloda (Capecitabine) and External Beam Radiation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Radiation Therapy; Capecitabine
Intervention description: 50-57 Gy per faction once or twice a day, 5 days a week, for about 5 -7 weeks, about 15-30 minutes each time.; During 5-7 weeks of radiation therapy, 825 mg/m2 (pills) by mouth, 2 times a day, about 12 hours apart, 30 minutes after eating food and about 2 hours before radiation therapy.
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Inflammatory Breast Cancer; Non-Inflammatory Breast Cancer; Capecitabine; Xeloda; Concomitant Radiation; Radiation Therapy; Radiotherapy; Women

Summary:

      The goal of this clinical research study is to find out if Xeloda® (capecitabine) and
      radiation therapy can help to control breast cancer that did not respond well to
      chemotherapy.

      The safety of this study treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histological confirmation of invasive breast cancer

          2. No contraindications to receiving a course of radiation treatment (pregnancy, prior
             radiation to the volume with disease, or systemic disease in which radiation therapy
             is an absolute contraindication)

          3. Patients who have chemo-refractory gross disease in the breast causing symptoms (pain,
             drainage, duress) OR gross disease in the breast (greater than or equal to T3) and/or
             lymph node(s) progressive, persistent, or minimally responsive to chemotherapy deemed
             inoperable or questionable inoperable OR Recurrent gross disease in a previously
             unirradiated breast or on the chest wall or in the regional lymphatics (core biopsy
             will not be offered to patients without gross disease in the breast).

          4. Are able to swallow and retain oral medication (intact pill)

          5. Age over 18

          6. Female gender

        Exclusion Criteria:

          1. Have an active or uncontrolled infection

          2. Have dementia, altered mental status, or any psychiatric condition that would prohibit
             the understanding or rendering of informed consent

          3. Have used an investigational drug within 21 days preceding the first dose of study
             medication

          4. Are receiving therapeutic anti-coagulation therapy (i.e. warfarin, heparin)

          5. Uncontrolled arrhythmia or congestive heart failure (CHF) based on clinical history or
             physical exam

          6. Patient cannot receive whole brain irradiation concurrently with Xeloda treatment.
Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant Urothelial Bladder Cancer
Condition: Metastatic Urothelial Carcinoma
MeSH terms: Carcinoma; Carcinoma, Transitional Cell
Intervention: pembrolizumab; ACP-196 in combination with pembrolizumab
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of the Combination of ACP-196 and Pembrolizumab in Subjects With Platinum Resistant
      Metastatic Urothelial Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age

          -  Histologically or cytologically confirmed urothelial carcinoma of the bladder or mixed
             histology bladder cancer

          -  Metastatic bladder cancer with disease progression on or after platinum-based
             chemotherapy

          -  Any primary site of urothelial carcinoma including upper tract, renal pelvis, bladder,
             and ureters

          -  Prior therapy with ≥ 1 systemic chemotherapy regimens for urothelial carcinoma

          -  Presence of radiographically measurable disease (defined as the presence of ≥ 1 lesion
             that measures ≥ 10 mm [≥ 15 mm for lymph nodes]

          -  ECOG performance status of 0 or 1

        Exclusion Criteria:

          -  Prior malignancy (other than bladder cancer), except for adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years of which will not limit survival to < 2
             years.

          -  Known central nervous system metastases and/or carcinomatous meningitis

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function

          -  Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias,
             congestive heart failure, or myocardial infarction within 6 months of screening
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
Condition: Pain; Postoperative Pain; Pain, Acute
MeSH terms: Toothache; Acute Pain
Intervention: MR-107A-01; Placebo
Intervention description: Oral tablet; Oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      MR-107A-01 is being studied to investigate its efficacy, safety, and dose-response after
      dental surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ≥18 years of age.

          2. Requirement for dental surgery for extraction of ≥2 x third molars, at least 1 of
             which involves partial or complete mandibular bony impaction.

          3. Pain Intensity (PI) using a Numeric Pain Rating Scale (NPRS) ≥5 during the 5 hours
             following the end of surgery.

          4. Rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e.,
             none, mild, moderate, severe) during the 5 hours following the end of surgery.

        Exclusion Criteria:

          1. Previously dosed with MR-107A-01.

          2. Subject with known hypersensitivity to nonsteroidal antiinflammatory drugs (NSAIDs).

          3. Active GI bleeding or a history of peptic ulcer disease, active inflammatory bowel
             disease, e.g., Crohn's Disease or ulcerative colitis, bleeding disorders that may
             affect coagulation.

          4. Use of any investigational drug within 28 days, or 5 half-lives, prior to screening
             whichever is longer.

          5. Use of medications with the potential to interact with MR-107A-01.

          6. Other acute or chronic medical or psychiatric condition or laboratory abnormality that
             may increase the risk associated with study participation or investigational product
             administration or may interfere with the interpretation of study results and, in the
             judgment of the investigator, would make the subject inappropriate for entry into this
             study.
Feasibility Trial of Intraperitoneal Chemotherapy for Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma
Condition: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Uterine Cancer
MeSH terms: Carcinoma; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms; Uterine Neoplasms
Intervention: Paclitaxel, Cisplatin IP
Intervention description: Paclitaxel 135 mg/m2 IV (3-hr infusion) on Day 1, Cisplatin 50 mg/m2 IP on Days 1 and 8, Repeat every 3 weeks for 6 cycles
Intervention MeSH terms: Paclitaxel; Cisplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma; Uterine Cancer; Intraperitoneal Chemotherapy; IP Chemotherapy; Gynecologic Cancer; Women's Cancer; Cisplatin; Paclitaxel; Recurrent Platinum Sensitive Ovarian Cancer

Summary:

      The purpose of this study is to evaluate giving chemotherapy drugs directly into the abdomen
      (belly) along with intravenous administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with stage IA, IB, IC, II, III, IV and recurrent platinum sensitive
             epithelial ovarian carcinoma, fallopian tube carcinoma, primary peritoneal carcinoma,
             or ovarian carcinosarcoma. Histologic subtypes which are eligible include serous
             adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated
             carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell
             carcinoma, malignant Brenner's tumor, adenocarcinoma (not otherwise specified), and
             carcinosarcoma.

          -  Patients with advanced endometrial carcinoma, of any histology, including endometrioid
             adenocarcinoma, clear cell adenocarcinoma, and serous papillary carcinoma.

          -  Patients with uterine carcinosarcoma of any stage are eligible.

        Exclusion Criteria:

          -  Patients with epithelial ovarian carcinoma of low malignant potential (borderline
             carcinomas).

          -  Patients with septicemia, severe infection, or acute hepatitis.

          -  Patients with prior malignancy or cancer treatment within the last five years.