bioihbjkbjnl/mcl2 huggingface dataset:
A Study of MM-111 and Paclitaxel With Trastuzumab in Patients HER2 Positive Carcinomas of the Distal Esophagus, Gastroesophageal (GE) Junction and Stomach
Condition: HER-2 Gene Amplification; Esophagus Cancer; Gastroesophageal Junction Cancer; Stomach Cancer
MeSH terms: Stomach Neoplasms; Esophageal Neoplasms
Intervention: MM-111; Paclitaxel; Trastuzumab
Intervention description: MM-111 (IV); Paclitaxel (IV); Trastuzumab (IV)
Intervention MeSH terms: Paclitaxel; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HER-2 Gene Amplification; Esophagus Cancer; Gastroesophageal Junction Cancer; Stomach Cancer; Her2 Positive; Her2+; Esophageal Cancer; Metastatic

Summary:

      To determine whether the combination of MM-111 plus paclitaxel and trastuzumab is more
      effective than paclitaxel and trastuzumab alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have documentation of histologically or cytologically confirmed
             metastatic or locally advanced adenocarcinoma of the distal esophagus, GE junction or
             stomach

          -  Patients must have documentation of histologically or cytologically confirmed HER2
             expression

          -  Patients must be ≥18 years of age

          -  Patients must have ECOG PS of 0, 1, or 2

          -  Patients must have adequate hematologic status, renal and hepatic function

        Exclusion Criteria:

          -  Patients with known hypersensitivity to any of the components of MM-111

          -  Patients with a known history of hypersensitivity to paclitaxel or other drugs
             formulated in Cremophor® EL

          -  Patients with a known history of hypersensitivity to trastuzumab or any of its
             components (group 1 patients only)

          -  Patients with an active infection or with an unexplained fever >38.5°C
Pharmacokinetics and Safety of MM36 Topical Ointment in Pediatric Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: MM36 topical ointment, 1%
Intervention description: Twice daily application for 28 consecutive days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the pharmacokinetic parameters and safety of topical
      MM36 (OPA-15406) ointment in pediatric subjects with atopic dermatitis under maximal use
      conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects 2 to <18 years of age

          -  Diagnosis of atopic dermatitis (AD)

          -  AD affecting ≥ 35% body surface area (BSA) if 2 to < 12 years of age or ≥ 25% if
             subject is ≥ 12 years of age (excluding scalp and venous access areas)

        Exclusion Criteria:

          -  Active or acute viral skin infection

          -  History of recurrent bacterial infection

          -  Malignancy

          -  Clinically significant history or physical findings that may pose a health risk to
             subject or may have an impact on study assessments
FACBC Prostate Therapy Response
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: FACBC PET-CT; MRI, CT, or Bone Scan
Intervention description: Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.; Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Imaging; Nuclear medicine; Oncology; Radiology; Urogenital disorders

Summary:

      The purpose of this study is to assess if using
      anti-1-amino-3-[18F]fluorocyclobutane-1-carboxylic acid (FACBC or fluciclovine) PET scan will
      be useful in determining if participants are responding to chemotherapy treatment.
      Investigators will enroll participants whose cancer has been treated with hormone therapy and
      now the cancer is not responding to the treatment (castration -resistant), and so therefore
      will be started on chemotherapy. Investigators aim to enroll thirty participants in this
      study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary or recurrent castration resistant prostate carcinoma with skeletal and/or
             nodal involvement not currently undergoing systemic chemotherapy who are about to
             commence therapy with docetaxel/prednisone. (Note that systemic hormonal targeted
             therapy including luteinizing hormone-releasing hormone (LHRH) agonists (Lupron or
             Trelstar), other anti-androgens, and/or Abiraterone or Enzalutamide may be in use.)

          -  Ability to lie still for PET scanning

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Age less than 18 years

          -  Inability to lie still for PET scanning

          -  Inability provide written informed consent

          -  Currently undergoing chemotherapy for organ confined or systemic disease. This does
             not preclude patients who had previously received upfront docetaxel in the hormone
             sensitive setting.
A Trial of Tisotumab Vedotin in Cervical Cancer
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Intervention: tisotumab vedotin
Intervention description: All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity
Intervention MeSH terms: Tisotumab vedotin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in
      Previously Treated, Recurrent or Metastatic Cervical Cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous
             cell, adenocarcinoma or adenosquamous histology who have experienced disease
             progressed on standard of care chemotherapy in combination with bevacizumab, if
             eligible.

          -  Measurable disease according to RECIST v1.1 as assessed by IRC.

          -  Age ≥ 18 years.

          -  Acceptable renal function

          -  Acceptable liver function

          -  Acceptable hematological status

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  A negative serum pregnancy test for patients of reproductive potential.

          -  All patients must provide a fresh or archival biopsy during screening.

          -  Following receipt of verbal and written information about the trial, patients must
             provide signed informed consent before any trial-related activity is carried out.

        Exclusion Criteria

          -  Have received no more than 2 prior systemic treatment regimens for recurrent or
             metastatic cervical cancer.

          -  Known past or current coagulation defects leading to an increased risk of bleeding;

          -  Ongoing major bleeding

          -  Active ocular surface disease

          -  Known past or current malignancy other than the inclusion diagnosis.

          -  Peripheral neuropathy grade ≥ 2
Bi 671800 in Asthmatic Patients on Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Intervention: BI 671800; Placebo
Intervention description: BI 671800; Placebo matching BI 671800
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To investigate the effectiveness and safety of BI 671800 given in the morning (AM), evening
      (PM) or twice daily (b.i.d.) compared too placebo as add on therapy to inhaled corticosteroid
      in symptomatic asthma patients.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed informed consent consistent with International Conference on Harmonisation
             (ICH) - Good Clinical Practice (GCP) (ICH-GCP)

          2. Three month history of reversible (12% with 200 mL) asthma according to [Global
             Initiative for Asthma (GINA)] with following spirometry at randomization:forced
             expiratory volume in 1 second (FEV1) 60%-85%.

          3. Stable inhaled corticosteroid (ICS) dose 3 months prior to screening.

          4. Diagnosis of asthma prior to 40 years.

          5. Asthma Control Questionnaire (ACQ) at least 1.5 at randomization.

          6. Male or female, 18 to 65 years.

          7. Non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine
             screen.

          8. Able to perform pulmonary function test (PFT).

        Exclusion criteria:

          1. Significant diseases other than asthma or allergic rhinitis.

          2. Hepatic transaminases or total bilirubin greater than 1.5 upper limit of normal (ULN).

          3. Hospitalizations for asthma or asthma related intubation within 3 months.

          4. Uncontrolled asthma on ICS + another controller.

          5. Respiratory tract infection or exacerbation within 4 weeks.

          6. FEV1 less than 40%, more than 12 puffs of short acting beta agonists (SABA) on more
             than two consecutive days or asthma exacerbation during the run-in period.

          7. Participation in another interventional study.

          8. Pregnant or nursing women.

          9. Women of child bearing potential nor using appropriate methods of birth control as
             defined by protocol.
Thiamine as a Metabolic Resuscitator After Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Intervention: Thiamine 500 mg IV; Placebo
Intervention description: Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.; 100mL of intravenous normal saline will be given every 12hours for 5 doses in the placebo arm
Intervention MeSH terms: Thiamine
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: A randomization list was prepared by an independent statistician using 1:1 randomization in blocks of four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 500mg dose is mixed in 100mL of normal saline. Placebo will be 100mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac arrest; post-arrest

Summary:

      This is a randomized, double-blind, placebo controlled study to investigate the effect of
      intravenous thiamine (vitamin B1) on lactate, cellular oxygen consumption, global oxygen
      consumption and biomarkers of neurologic injury after out-of-hospital cardiac arrest (OHCA).
      .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patient (age ≥ 18 years)

          -  Cardiac arrest occurring with sustained (> 20 minutes) return of spontaneous
             circulation (ROSC)

          -  Within 4.5 hours of cardiac arrest event

          -  Lactate >/=3

        Exclusion Criteria:

          -  Clinical indication for thiamine administration (alcoholism, known or highly suspected
             deficiency) or treatment with thiamine beyond the amount found in a standard
             multivitamin within the last 10 days

          -  Traumatic etiology of arrest

          -  Comfort measures only or anticipated withdrawal of support within 24 hours

          -  Protected populations (pregnant women, prisoners)

          -  Known allergy to thiamine
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.
Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma
Condition: Eosinophilic Asthma; Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: Dexpramipexole; Placebo
Intervention description: dexpramipexole twice daily oral dosing for up to 12 weeks; placebo twice daily oral dosing for up to 12 weeks
Intervention MeSH terms: Pramipexole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Four-arm parallel assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 534.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Eosinophilic Asthma; Asthma; dexpramipexole

Summary:

      This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging,
      multi-center study to evaluate the clinical effects of oral administration of dexpramipexole
      for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 and <75 years of age at the time of consent

          -  Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global
             Initiative for Asthma (GINA) 2018 Guidelines

          -  Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in
             combination with a long-acting β2 agonist, on a stable dose for at least 1 month
             before Screening

          -  Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15
             to 25 minutes following inhalation of albuterol at Screening

          -  Pre-bronchodilator FEV1 ≥40% and <80% of predicted at Screening and Baseline

          -  AEC ≥0.30 x10^9/L at the Screening visit

          -  ACQ-7 ≥1.5 at Screening

          -  Negative pregnancy test at Baseline

          -  Adherence ≥85% with twice-daily placebo taken during the Run-in Period

        Exclusion Criteria:

          -  Treatment for an asthma exacerbation within 8 weeks prior to Baseline visit

          -  Treatment with systemic corticosteroids in the 8 weeks prior to Screening

          -  Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline

          -  Treatment with selected drugs known to have a substantial risk of neutropenia

          -  Absolute neutrophil count <2.0x10^9/L at Screening, or any documented history of
             absolute neutrophil count <2.0x10^9/L.

          -  Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60
             mL/min/1.73m^2 at Screening

          -  Clinically significant abnormal laboratory or ECG values

          -  Other medically significant illness

          -  Use of any smoke or inhaled nicotine delivery device within 1 year prior to Screening

          -  Pregnant women or women breastfeeding

          -  Currently taking pramipexole or other dopamine agonists
A Randomized Study of Safety and Efficacy of Pazopanib and Gemcitabine in Persistent or Relapsed Ovarian Cancer
Condition: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Intervention: Gemcitabine; pazopanib
Intervention description: Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.; Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: recurrent; persistent

Summary:

      Ovarian cancer is the leading cause of gynecologic cancer deaths, and the fifth most common
      cause of cancer deaths in women. While approximately 75% of patients with epithelial ovarian
      cancer will respond to first-line chemotherapy with platinum and paclitaxel, most patients
      with advanced stage epithelial ovarian cancer will experience disease recurrence. Pazopanib
      is a novel agent has recently been approved for the treatment of subjects with advanced renal
      cell carcinoma (RCC), and preclinical studies suggest it may be effective in other cancers
      such as ovarian cancer. Therefore, the purpose of this study is to test the efficacy and
      safety of a novel agent, pazopanib, as an adjunct to a standard treatment, gemcitabine, for
      recurrent or persistent ovarian cancer. This is an open label study in which subjects will be
      randomized 1:1 to receive 4 cycles of either gemcitabine, or gemcitabine with pazopanib.
      Gemcitabine will be administered as an IV infusion weekly on days 1 and 8 of a 21 day cycle.
      Subjects randomized to receive pazopanib will take 800 mg daily during the 21 day cycle. All
      subjects will be monitored for toxicity and other indicators of safety (labs, physical exams,
      vitals) at intervals throughout the treatment cycles. Subjects will be followed for up to 5
      years following the conclusion of treatment to evaluate efficacy. The primary endpoints of
      the study are progression free survival and overall survival, which will be assessed at three
      years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years old

          -  Must have measurable or detectable ovarian, fallopian or primary peritoneal cancer

          -  Must have been treated previously with carboplatin, cisplatin or another
             organoplatinum compound

        Exclusion Criteria:

          -  Women who are pregnant or nursing

          -  History of congenital long QT syndrome

          -  Active bleeding or at risk of a bleeding disorder

          -  Other significant medical condition or history of medical condition which may put the
             patient at risk
Neoadjuvant Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin Locally Advanced Rectal Cancer
Condition: Locally Advanced Rectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Oxaliplatin; Bevacizumab; Capecitabine; radiotherapy
Intervention description: Administered on days 15,22,29,36 en 43; 50 mg/m2; Administered on days 1,15,29 and 43 ; 5mg/kg; 825 mg/m2 ; 25 days - 5days per week, concurrent with radiotherapy; Total dose 45Gy
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: bevacizumab; capecitabine; radiation therapy; oxaliplatin; multimodality treatments; TME (total mesorectal excision); Axe Beam; rectal cancer; neoadjuvant; pathological complete response; postoperative complications

Summary:

      Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly
      multinational). Academic, investigator initiated.

      To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM)
      and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment
      of locally advanced rectal cancer, followed by TME (total mesorectal excision).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adenocarcinoma of rectum measurable (RECIST), locally advanced (defined by MRI -
             Tumour beyond mesorectal fascia (T4) or Tumour ≤ 2 mm from mesorectal fascia or T3
             tumour < 5 cm from anal verge

          -  Patient is at least 18 years of age

          -  Good organ function

        Exclusion Criteria:

          -  Evidence of distant metastases

          -  Contraindication for bevacizumab

          -  Pregnant or breastfeeding women.