bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RO5185426 in Previously Treated Melanoma Patients With Brain Metastases
Condition: Malignant Melanoma
MeSH terms: Melanoma; Brain Neoplasms
Intervention: RO5185426
Intervention description: 960 mg b.i.d. orally
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label study will assess the safety and efficacy of RO5185426 in previously treated
      metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose
      of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Metastatic melanoma (Stage IV, American Joint Committee on Cancer) with BRAF mutation
             (cobas 4800 BRAF V600 Mutation Test)

          -  Brain metastases for which surgical resection is not a treatment option

          -  Patients must have failed at least one previous treatment for brain metastases

          -  Requiring corticosteroids for symptom control

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

        Exclusion Criteria:

          -  Increasing corticosteroid dose during the 7 days prior to study entry

          -  Previous malignancy within the past 2 years, except for basal or squamous cell
             carcinoma of the skin or carcinoma in-situ of the cervix

          -  Concurrent administration of any anticancer therapies other than those administered in
             the study

          -  Clinically significant cardiovascular disease or event within the 6 months prior to
             first dose of study drug
Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydrocodone/Acetaminophen Extended Release; Acetaminophen; Morphine Extended Release; Placebo
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Morphine; Hydrocodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 250.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Postoperative Pain

Summary:

      The primary purpose of this study was to evaluate analgesic efficacy and safety of
      hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain
      following primary unilateral first metatarsal bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

        - Subjects who were in general good health, experiencing moderate to severe pain following
        bunionectomy surgery and who were willing to remain confined for approximately 4 days
        following surgery for study procedures.

        Exclusion Criteria:

          -  Subjects who underwent Base wedge osteotomy and/or Long-Z hart bunionectomy procedures

          -  Allergic reaction to study medications

          -  Pregnant or breastfeeding females

          -  Clinically significant lab abnormalities at screening

          -  Positive hepatitis testing at screening

          -  Clinically significant or uncontrolled medical disorders or illness at screening

          -  Active malignancy or chemotherapy

          -  Any history of drug or alcohol abuse/addiction

          -  Known or suspected history of human immunodeficiency virus (HIV); requires treatment
             with monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) or
             butyrophenones

          -  History of major depressive episode or major psychiatric disorder

          -  Current systemic corticosteroid therapy

          -  Inability to refrain from smoking during or alcohol during stay at investigative site
Safety and Efficacy of MK-8457 and Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Despite MTX Therapy (P08683, MK-8457-008)
Condition: Rheumatoid Arthritis (RA)
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: MK-8457 100 mg; Dose-Matched Placebo; Methotrexate
Intervention description: MK-8457 100 mg dosed orally BID; Dose-matched placebo dosed orally BID; MTX dosed at the stable dose receive upon study entry
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and efficacy of MK-8457 + Methotrexate
      (MTX) in participants with active rheumatoid arthritis (RA) despite MTX therapy. The primary
      hypothesis is that at least 1 dose of MK-8457 + MTX will be superior to placebo + MTX as
      measured by the percentage of participants who achieve American College of Rheumatology 20
      (ACR 20) response after 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis for at least 6 months prior to screening

          -  Active rheumatoid arthritis as defined by the presence of >= 6 swollen joints (of 66
             count) and >= 6 tender joints (of 68 joint count)

          -  C-reactive protein blood level >0.9 mg/dL

          -  Anti-citrullinated protein antibody positive and/or rheumatoid factor positive at
             screening

          -  American College of Rheumatology Functional Class I, II, or III

          -  Received methotrexate for a minimum of 3 months prior to screening with a regionally
             appropriate stable weekly dose for at least 4 weeks prior to screening

          -  If using oral corticosteroids, the participant must be on a stable dose of 10 mg
             prednisone

          -  No history of either untreated, latent, or active tuberculosis prior to baseline

          -  Participants of reproductive potential must agree to remain abstinent or use 2
             acceptable methods of birth control

        Exclusion Criteria:

          -  Presence of inflammatory disease other than rheumatoid arthritis, including but not
             limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus,
             or Lyme disease

          -  Positive hepatitis B surface antigen or hepatitis C test result or the presence of
             Human immunodeficiency virus (HIV) infection

          -  HIV positive

          -  User of recreational or illicit drugs or has had a history (within the previous 2
             years) of drug or alcohol abuse or dependence

          -  Females of childbearing potential who are pregnant, intend to become pregnant, or are
             lactating;

          -  Severe opportunistic infection within 6 months prior to study start.
Study of ABT-267 in Treatment Naive Hepatitis C Virus (HCV) Genotype 1 Infected Subjects
Condition: Chronic Hepatitis C; Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-267; Pegylated interferon (pegIFN); Ribavirin (RBV); Placebo for ABT-267
Intervention description: 5 mg or 25 mg tablets; Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly; 200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day; Participants received matching placebo tablet at each dose level for ABT-267.
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid
      virologic response (RVR) of 3 different doses of ABT-267 (also known as ombitasvir) in
      combination with pegylated interferon/ribavirin (pegIFN/RBV) compared with pegIFN/RBV alone
      (ABT-267 placebo) in treatment naïve, hepatitis C virus (HCV), genotype 1-infected
      participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Treatment naïve participants

          -  Females must be either postmenopausal for at least 2 years or surgically sterile

          -  Males must be surgically sterile or practicing specific forms of birth control

          -  Chronic hepatitis C virus (HCV), genotype-1 infected participants

          -  Documented FibroTest score in combination with an Aspartate Aminotransferase to
             Platelet Ratio Index (APRI), or a liver biopsy within the last 12 months to document
             absence of cirrhosis

        Exclusion Criteria:

          -  Pregnant or breastfeeding female

          -  Use of any medications contraindicated for use with pegylated interferon(pegIFN) or
             ribavirin (RBV) 2 weeks prior to study drug administration or 10 half-lives, whichever
             is longer

          -  Clinically significant cardiac, respiratory (except mild asthma), renal,
             gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness
             or psychiatric disease or disorder

          -  Current or past clinical evidence of cirrhosis or bridging fibrosis

          -  Abnormal screening laboratory results
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: SOF/VEL; RBV
Intervention description: 400/100 mg FDC tablet administered orally once daily; RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir; Sofosbuvir-velpatasvir drug combination; Velpatasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 204.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
      of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and
      ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV)
      infection and compensated cirrhosis.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  Individuals with chronic genotype 3 HCV infection and compensated cirrhosis

          -  Individuals with or without HIV-1 coinfection

        Key Exclusion Criteria:

          -  History of clinically significant illness or any other medical disorder that may
             interfere with individual's treatment assessment or compliance with the protocol

          -  Co-infection with active hepatitis B virus

          -  Laboratory results outside the acceptable ranges at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT
Condition: Peritoneal Neoplasms; Ascites; Yang Deficiency; Yin Deficiency
MeSH terms: Peritoneal Neoplasms; Ascites; Yin Deficiency; Yang Deficiency
Intervention: Modulated Electro-Hyperthermia (mEHT); TCM Herbal Decoction (Shi Pi); IPCI (CDDP+5FU)
Intervention description: MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.; Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.; Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Peritoneal Carcinomatosis; Malignant Ascites; Modulated Electro-Hyperthermia; Traditional Chinese Medicine

Summary:

      This trial studies efficacy and safety of combination of modulated electro-hyperthermia
      (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with
      malignant ascites versus standard chemoinfusion (CDDP+5FU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed PC with malignant ascites.

          -  Karnofsky Performance Status (KPS) score ≥60%.

          -  Normal function of bone marrow.

          -  Predicted survival time >1 month.

          -  Written informed consent.

        Exclusion Criteria:

          -  Surgery within 3 weeks or not full recovery of postoperative suture.

          -  Active bleeding or vascular occlusion in the mEHT treatment area.

          -  Emotional instability.

          -  Impossibility to place the patient into the mEHT machine.

          -  Metallic implants or replacements in the treatment area.

          -  Electronic implanted devices anywhere.

          -  Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment
             area.

          -  Very low white blood cell count (<1.5×10(9)/L), agranulocytosis (<0.5×10(9)/L) or
             severe anemia.
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.
Repeat Quadratus Lumborum Block to Reduce Opioid Need in Patients After Pancreatic Surgery
Condition: Pancreatic Carcinoma
MeSH terms: Pancreatic Neoplasms
Intervention: Best Practice; Quadratus Lumborum Block; Quality-of-Life Assessment; Questionnaire Administration
Intervention description: Given standard of care; Undergo QL block; Ancillary studies; Ancillary studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how an additional anesthetic nerve block, called a quadratus
      lumborum block, works to reduce the need for opioids in patients after pancreatic surgery.
      Giving an additional regional anesthetic after surgery may hasten the weaning process, reduce
      the need for opioid medications upon discharge, and reduce the risk of opioid dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing elective open pancreatic resection for potentially curative intent
             (pancreaticoduodenectomy or distal pancreatectomy) who would otherwise be treated with
             QL block + IV-PCA converted to oral pain meds (non-narcotic bundle + opioid pain
             pill).

        Exclusion Criteria:

          -  Patients with current or past substance (drug or alcohol) abuse disorder.

          -  Laparoscopic or minimally invasive surgery.
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: VX-561; IVA; Placebo; Placebo
Intervention description: VX-561 tablets for oral administration.; 150-mg film-coated tablet for oral administration.; Placebo matched to IVA.; Placebos matched to VX-561.
Intervention MeSH terms: Ivacaftor
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 77.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and
      pharmacokinetic (PK) effect of VX-561.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have 1 of the following 9 CFTR mutations on at least 1 allele: G551D, G178R,
             S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D

          -  On ivacaftor therapy

          -  FEV1 value ≥40% and ≤100% of predicted mean for age, sex, and height

        Key Exclusion Criteria:

          -  History of clinically significant cirrhosis with or without portal hypertension

          -  History of solid organ or hematological transplantation

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

        Other protocol defined Inclusion/Exclusion criteria may apply
Eight-Week Efficacy & Safety Study of Brisdelle™ (Formerly Known as Mesafem) in the Treatment of Vasomotor Symptoms Associated With Menopause
Condition: Hot Flashes
MeSH terms: Hot Flashes
Intervention: Brisdelle (paroxetine mesylate); Sugar pill
Intervention description: Eligible subjects will be randomized to receive Brisdelle™ (paroxetine mesylate) Capsules 7.5 mg.; Subjects will receive a sugar pill.
Intervention MeSH terms: Paroxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: Female
Minimum age: 41 Years
Healthy volunteers: No
Keywords: Menopause; Vasomotor Symptoms; Hot flash; Perimenopause; Nonhormonal therapies; Climacteric symptoms; Mesafem; Low-Dose Mesylate salt of Paroxetine (LDMP)

Summary:

      This is an exploratory 8-week, multicenter, double-blind, randomized, placebo-controlled
      study of Brisdelle (paroxetine mesylate) Capsules 7.5 mgin subjects with moderate to severe
      postmenopausal vasomotor symptoms (VMS), defined as follows:

        -  Moderate VMS: Sensation of heat with sweating, able to continue activity

        -  Severe VMS: Sensation of heat with sweating, causing cessation of activity
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female, >40 years of age

          2. Reported more than 7-8 moderate to severe hot flashes per day (average) or 50-60
             moderate to severe hot flashes per week for at least 30 days prior

          3. Spontaneous amenorrhea for at least 12 consecutive months

          4. Amenorrhea for at least 6 months and meet the biochemical criteria for menopause

          5. Bilateral salpingo-oophorectomy >6 weeks with or without hysterectomy

        Exclusion Criteria:

          1. History of hypersensitivity or adverse reaction to paroxetine mesylate

          2. Use of an investigational study medication within 30 days prior to screening or during
             the study

          3. Concurrent participation in another clinical trial or previous participation in this
             trial

          4. Family of investigational-site staff
Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: Sotatercept
Intervention description: single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Red Blood Cell Mass; Plasma Volume; Solid Tumors

Summary:

      What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by
      dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has
      determined that all of these goals could be obtained by an intense 10-patient sotatercept
      (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell
      production field.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥18 years of age.

          -  Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology
             or biopsy.

          -  Presence of metastatic disease.

          -  Hemoglobin value between ≥8.0 to <11.0 g/dL (≥80 to <110 g/L).

          -  ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume
             test) since previous treatment with erythropoiesis-stimulating agent (including
             concurrent treatment with intravenous [IV] iron).

          -  ≥28 days must have elapsed (prior to Day 1) since the last red blood cell transfusion
             and receipt of ≤2 units of blood in the past 56 days (prior to Day 1).

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.

        Exclusion Criteria:

        At the time of screening, participants who have any grade ≥3 toxicity (according to the
        currently active minor version of NCI CTCAE v4.0) except for the following disease-related
        toxicities:

          -  Hematological events - anemia, thrombocytopenia, neutropenia

          -  Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain