bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, and Efficacy of GS-9876 in Participants With Active Rheumatoid Arthritis on Background Therapy With Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: GS-9876; Filgotinib; GS-9876 placebo; Filgotinib placebo; Methotrexate
Intervention description: One tablet administered orally once daily; Two tablets administered orally once daily; One tablet administered orally once daily; Two tablets administered orally once daily; Background therapy with methotrexate administered orally or parenterally once weekly
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the effect of GS-9876 versus placebo for
      the treatment of signs and symptoms of rheumatoid arthritis (RA) in participants with active
      RA as measured by change from baseline in Disease Activity Score for 28 joint count using
      C-reactive protein (CRP) (DAS28 (CRP)) at Week 12.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Active RA disease as defined by: a tender joint count (TJC) of ≥ 6 (out of 68), a
             swollen joint count (SJC) of ≥ 6 (out of 66) at screening and Day 1

          -  Inadequate response to treatment with oral or parenteral methotrexate (MTX) 7.5 to 25
             mg/week continuously for at least 12 weeks

          -  No evidence of active or latent tuberculosis

        Key Exclusion Criteria:

          -  Prior treatment with B-cell depleting agents (eg, rituximab), unless more than 6
             months prior to the first dose of study drug and documented return of CD19+ cells at
             screening

          -  Prior treatment with any commercially available or investigational spleen tyrosine
             kinase (SYK) inhibitor

          -  Concurrent treatment with any other conventional synthetic DMARD (csDMARD) other than
             MTX and/or hydroxychloroquine (HCQ) (prior csDMARD treatment allowed if appropriate
             wash out as defined in the protocol)

          -  Concurrent treatment with any biological disease modifying anti-rheumatic drug
             (bDMARD)(prior bDMARD treatment allowed if appropriate wash out as defined in the
             protocol). Prior failure to treatment with bDMARDs is not an exclusion criterion.

        Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Placebo; PF-03715455
Intervention description: Orally inhaled placebo twice a day (BID) for 4 weeks; 680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 13.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD; Sputum

Summary:

      This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with
      moderate to severe Chronic Obstructive Pulmonary Disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of non-childbearing potential and male subjects between the ages of 40
             and 80 years, inclusive

          -  Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who
             meet the criteria for Stage II-III disease

          -  Subjects must have a smoking history of at least 10 pack-years

        Exclusion Criteria:

          -  Current evidence or history within the previous 6 months of any clinically significant
             disease (other than COPD) or abnormality in the opinion of the Investigator that would
             put the subject at risk or which would compromise the quality of the study data

          -  A COPD exacerbation requiring treatment with oral steroids or hospitalization for the
             treatment of COPD within 3 months of Screening
Long-term Extension From RCC Phase II (11515)
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Sorafenib (Nexavar, BAY43-9006)
Intervention description: Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
Intervention MeSH terms: Sorafenib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sorafenib; Nexavar; Metastatic RCC; Renal Cell Carcinoma; Unresectable RCC

Summary:

      Extension to study 11515 (NCT00661375) which was a multicenter study of sorafenib in patients
      with renal cell carcinoma (RCC).
    

Eligibility criteria:

        Inclusion Criteria:

        Patients are classified into two groups as below at transition date from Study 11515 to
        this study.

        Population I: Patients who are willing to continue the study drug, for whom the
        investigator consider continuation of the study drug is appropriate, and who do not meet
        the criteria of removal from the study in Study 11515 at the end of Study 11515.

        Population II: Patients who have been monitored only for survival status at the end of
        Study 11515.

        Population 1

          1. Patients who are willing to continue the study drug,

          2. Patients for whom the investigator consider continuation of the study drug is
             appropriate

          3. Patients who do not meet the criteria of removal from the study in Study 11515 at the
             end of Study 11515.

          4. Patients who give written informed consent prior to any study specific screening
             procedures with the understanding that the patient has the right to withdraw from the
             study at any time, without prejudice.

        Population 2

        1. Patients who give written informed consent prior to any study specific screening
        procedures with the understanding that the patient has the right to withdraw from the study
        at any time, without prejudice.

        Exclusion Criteria:

          1. Substance abuse, medical, psychological or social conditions that may interfere with
             the patient's participation in the study or evaluation of the study results

          2. Any condition that could jeopardize the safety of the patient or that affect his/her
             compliance in the study

          3. Pregnant or breast-feeding patients. Both men and women enrolled in this trial must
             use adequate birth control.
An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Telaprevir; Peg-IFN-alfa-2a; Peg-IFN-alfa-2b; Ribavirin (RBV) tablet; Ribavirin (RBV) capsule
Intervention description: Oval tablets containing 375 mg of telaprevir for oral administration.; Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.; Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.; Tablets containing 200 mg RBV for oral administration.; Capsules containing 200 mg RBV for oral administration.
Intervention MeSH terms: Ribavirin; Interferon-alpha; Interferon alpha-2; Interferon-alfa-1b; Peginterferon alfa-2a; Peginterferon alfa-2b
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 166.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Chronic Hepatitis C; Genotype 1; Telaprevir; Treatment-naïve; VX-950-C208; VX-950-TiDP24-C208

Summary:

      The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics
      (the study of the way a drug enters and leaves the blood and tissues over time), and
      pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different
      doses in combination with two standard therapies commercially available for chronic (lasting
      a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic genotype 1 Hepatitis (inflammation of the liver) C infection

          -  Never been treated for Hepatitis C Viral (HCV) infection

          -  No clinically significant lab abnormalities

          -  Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international
             units/milliliter (IU/mL) at entry

          -  Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

        Exclusion Criteria:

          -  Contra-indications for starting anti-HCV therapy

          -  History or evidence of liver cirrhosis (serious liver disorder in which connective
             tissue replaces normal liver tissue, and liver failure often occurs) or decompensated
             liver disease

          -  Any evidence of significant liver disease in addition to Hepatitis C

          -  Infected with Human Immunodeficiency Virus (a life-threatening infection which you can
             get from an infected person's blood or from having sex with an infected person) or
             Hepatitis B

          -  Women who are pregnant (carrying an unborn baby), planning to be pregnant or
             breastfeeding or the partner of a woman who is pregnant or breastfeeding
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
Condition: Primary Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: Milnacipran; Placebo
Intervention description: Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study.
Oral administration, twice daily dosing; matching placebo tablets daily
Intervention MeSH terms: Milnacipran; Levomilnacipran
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 116.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Fibromyalgia; Pediatric Fibromyalgia; Adolescent Fibromyalgia; milnacipran; Savella; loss of therapeutic response; Forest Research Institute; Pain; Fatigue; Serotonin Norepinephrine Reuptake Inhibitors; Randomized Withdrawal

Summary:

      The purpose of this study is to evaluate the safety, tolerability, efficacy, and
      pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary
      fibromyalgia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of primary fibromyalgia

          -  13-17 years of age

          -  To be eligible for screening, have average pain rating in the previous week of at
             least 3 but no more than 9 on an 11-point numeric rating scale

          -  To be eligible to enter into the open-label treatment period, have a 1-week mean of
             daily pain ratings of at least 3 but no more than 9 (11-point numeric rating scale) in
             the week before Baseline (Visit 2)

          -  To be eligible for randomization and entry into the double-blind treatment period,
             have a decrease of at least 50% in 1-week mean of daily pain ratings (11-point numeric
             rating scale) before Randomization (Visit 7) compared with the 1-week mean of daily
             pain ratings, in the week before Baseline (Visit 2)

          -  Unsatisfactory response to nonpharmacologic fibromyalgia treatment.

        Exclusion Criteria:

          -  Severe psychiatric illness

          -  Severe renal impairment

          -  Evidence of active liver disease

          -  Pregnant or breastfeeding

          -  Significant risk of suicidality

          -  Unable, unwilling or inadvisable to discontinue prohibited medications

          -  History of alcohol abuse or drug abuse or dependence, within previous year

          -  Current systemic infection

          -  Autoimmune disease

          -  History of seizure disorder (other than febrile seizures)
A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: enzastaurin; placebo; docetaxel; prednisone
Intervention description: 1125 mg loading dose, then 500 mg po QD until disease progression, toxicity, or maximum 3 years; Loading dose, then po QD until unblinding; 75 mg/m^2 IV, every 21 days, six 21-day cycles, maximum 10 cycles; 5 mg po BID, six 21-day cycles
Intervention MeSH terms: Prednisone; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the response rates for prostate cancer patients taking
      chemotherapy plus enzastaurin versus chemotherapy plus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You are at least 18 years old.

          -  You live close enough to the doctor's office to attend all of your required visits.

          -  You have not been treated with chemotherapy for your prostate cancer.

          -  Your organs must be functioning properly.

        Exclusion Criteria:

          -  You are unable to swallow pills.

          -  You have another serious illness besides your prostate cancer.

          -  You have taken another experimental drug within the last 30 days.

          -  You have a serious heart condition.

          -  You are receiving another anti-cancer therapy.
Safety and Efficacy of NYX-783 in Subjects With Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Intervention: Placebo oral capsule; NYX-783
Intervention description: Matching placebo capsules.; NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to receive placebo or NYX-783.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To evaluate the safety, tolerability, and response profile of NYX-783 in a Post-Traumatic
      Stress Disorder population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A primary diagnosis of PTSD [Post Traumatic Stress Disorder, according to DSM-5
             (Diagnostic and Statistical Manual of Mental Disorders)] with the primary traumatic
             event occurring ≥12 months prior to screening.

          -  PCL-5 (PTSD Checklist for DSM-5) ≥38 at screening.

          -  CAPS-5 (Clinician-Administered PTSD Scale for DSM-5) total score ≥30 at screening.

        Exclusion Criteria:

          -  Complex PTSD.

          -  Trauma focused psychotherapies.

          -  Primary traumatic event occurred prior to 2001.

          -  Primary traumatic event was followed by further major traumatic life episodes.

          -  Other psychiatric disorders that is the primary focus of treatment or
             followed/worsened since exposure to the trauma (except for major depressive disorder
             or anxiety disorders that followed exposure to the trauma or an anxiety disorder that
             showed a worsening after trauma)

          -  Current use of medications with primarily central nervous system activities

          -  Other clinically significant medical histories that may interfere with completing the
             study.
Phase 2 Study of Indomethacin Capsules to Treat Dental Pain
Condition: Dental Pain
MeSH terms: Toothache
Intervention: Celecoxib 400 mg; Placebo; Indomethacin Test (lower dose); Indomethacin Test (upper dose)
Intervention description: Capsules 2 x 200 mg Single-Dose; Capsules 2 Single-Dose; 20-mg single dose; 40-mg single dose
Intervention MeSH terms: Celecoxib; Indomethacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Indomethacin Test Formulation Capsules are
      safe and effective for the treatment of dental pain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female between 18 and 50 years of age

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Patient requires extraction of 2 or more third molars

          -  Patient must be willing to stay at the study site for at least 8 hours after dosing of
             the study drug

        Exclusion Criteria:

          -  Patient has hypersensitivity, allergy, or clinically significant intolerance to any
             medications to be used in the study, or related drugs

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen or alcohol breathalyzer test

          -  Patient has taken another investigational drug within 30 days prior to Screening
Sym004 in SCCHN Patients Failing Anti-EGFR Based Therapy
Condition: Carcinoma, Squamous Cell of Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Sym004
Intervention description: Sym004 will be administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The trial is designed as a multi-center, open label Phase 2 trial that investigates the
      efficacy and safety of Sym004 in subjects with squamous cell cancer of the head and neck
      (SCCHN). Subjects included must have responded to previous anti-epidermal growth factor
      receptor (anti-EGFR) monoclonal antibody-based therapy and subsequently become resistant to
      that therapy. It is believed that Sym004 has the potential to induce tumor responses and
      provide a superior treatment option to subjects with advanced SCCHN.

      Symphogen was the sponsor for planning/conducting and reporting results for this trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis initially or at relapse of SCCHN of the oral
             cavity, oropharynx, hypopharynx or larynx

          -  Recurrent and/or metastatic SCCHN not amenable to curative treatment with surgery
             and/or (chemo)radiation

          -  Previous treatment with an anti-EGFR monoclonal antibody (mAb) in the palliative
             setting either as monotherapy or in combination with chemotherapy or radiotherapy and
             showing:

               -  Documented clinical benefit or response for at least 8 weeks (PR, CR or SD) on
                  the anti-EGFR mAb-based therapy and

               -  Documented disease progression (verified by computed tomography [CT] scan or
                  magnetic resonance imaging [MRI] according to RECIST (1.1) during or within 12
                  weeks following the last administration of anti-EGFR mAb

          -  Accessible tumor for biopsy and subject acceptance of repeat tumor biopsies

          -  Other protocol-defined inclusion criteria could apply

        Exclusion Criteria:

          -  More than 2 lines of prior chemotherapy in the palliative setting

          -  Expected survival <12 weeks

          -  Subjects with known brain metastases

          -  Chemotherapy or radiation therapy within 21 days prior to Visit 2 at the exception of
             palliative radiotherapy for bleeding or pain, which is allowed anytime, if not given
             on target lesions

          -  Anti-EGFR mAbs within 14 days prior to Visit 2

          -  Major surgery within 4 weeks prior to Visit 2 and subjects must have recovered from
             effects of major surgery

          -  Other protocol-defined exclusion criteria could apply
A Safety and Efficacy Study of LiRIS® in Females With Interstitial Cystitis/Bladder Pain Syndrome
Condition: Cystitis, Interstitial; Painful Bladder Syndrome
MeSH terms: Cystitis; Cystitis, Interstitial; Syndrome
Intervention: LiRIS®; LiRIS Placebo
Intervention description: LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.; LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 131.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of LiRIS® in females with interstitial cystitis/bladder
      pain syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of interstitial cystitis or bladder pain syndrome

        Exclusion Criteria:

          -  Diagnosis of interstitial cystitis with Hunner's lesions/ulcers

          -  Previous treatment with LiRIS®