bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
Condition: Uveitis
MeSH terms: Uveitis; Panuveitis
Intervention: adalimumab
Intervention description: Adalimumab, pre-filled syringe, administered by SC injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Intermediate-Uveitis; Non-infectious Uveitis; Posterior-Uveitis; Active Uveitis; Pan-uveitis; Uveitis

Summary:

      The purpose of this study is to evaluate the long term efficacy and safety of adalimumab
      participants with non-infectious intermediate-, posterior- or pan-uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have successfully enrolled in either study M10-877 or M10-880 and
             either met the endpoint of "Treatment Failure" or completed the study

        Exclusion Criteria:

          -  A participant will be excluded from this study if the participant discontinued from
             study M10-877 or M10-880 for any reasons other than having a Treatment Failure event

          -  Participant with corneal or lens opacity that precludes visualization of the fundus or
             that likely requires cataract surgery during the duration of the trial

          -  Participants with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications
             or evidence of glaucomatous optic nerve injury

          -  Participant with proliferative or severe non-proliferative diabetic retinopathy or
             clinically significant macular edema due to diabetic retinopathy

          -  Participant with neovascular/wet age-related macular degeneration

          -  Participant with abnormality of vitreo-retinal interface (i.e., vitreomacular
             traction, epiretinal membranes, etc.) with the potential for macular structural damage
             independent of the inflammatory process

          -  Participant with a systemic inflammatory disease that requires therapy with a
             prohibited immunosuppressive agent at the time of study entry
2. Study to Evaluate the Efficacy/Safety of Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Intervention: Bremelanotide; Placebo
Intervention description: A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone); Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 714.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HSDD Female; Sexual Desire Disorder; decreased desire; female sexual dysfunction

Summary:

      A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an
      optional Open-label Extension to evaluate the efficacy of bremelanotide (BMT), administered
      subcutaneously (SC) on an as needed basis for the treatment of HSDD (with or without
      decreased arousal) in premenopausal females.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Has met diagnostic criteria for HSDD for at least 6 months

          -  Is willing and able to understand and comply with all study requirements

          -  Has a normal pelvic examination at screening

        Main Exclusion Criteria:

          -  Subjects should be generally healthy premenopausal females with no psychological,
             gynecological or urological conditions which might contribute to the sexual
             dysfunction, compromise study participation, or confound interpretation of the study
             results

          -  Not currently under treatment for the sexual dysfunction and willing to forego other
             treatments through the course of the clinical trial
Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo; Apremilast
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Apremilast; Deucravacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 666.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the experimental medication BMS-986165 compared
      to placebo and a currently available treatment in participants with moderate to severe plaque
      psoriasis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Plaque psoriasis for at least 6 months

          -  Moderate to severe disease

          -  Candidate for phototherapy or systemic therapy

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  History of recent infection

          -  Prior exposure to BMS-986165 or active comparator

        Other protocol defined inclusion/exclusion criteria apply
Andecaliximab With mFOLFOX6 as First Line Treatment for Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Condition: Gastric Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Andecaliximab; Placebo; Leucovorin; 5-fluorouracil; Oxaliplatin
Intervention description: 800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle; Administered intravenously on Days 1 and 15 of each treatment cycle; Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle; Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle; Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 432.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Gastroesophageal junction (GEJ); Stomach cancer

Summary:

      The primary objective of this study is to compare the efficacy of andecaliximab (GS-5745)
      versus placebo in combination with modified fluorouracil (5-FU), leucovorin (LV), and
      oxaliplatin (OXA) (mFOLFOX6) as measured by overall survival.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Adults with histologically confirmed adenocarcinoma of the stomach or gastroesophageal
             junction that is inoperable, locally advanced or metastatic and not amenable to
             curative therapy

          -  Adequate hematologic, liver, coagulation and kidney function

          -  Eastern Cooperative Oncology Group (ECOG) ≤ 1

          -  Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1

        Key Exclusion Criteria:

          -  Previous chemotherapy for locally advanced or metastatic gastric cancer.

          -  Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric cancer

          -  HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection

          -  Pregnant or breast feeding women

          -  Individuals with known or suspected central nervous system metastases or individuals
             requiring chronic daily treatment with oral corticosteroids

          -  Grade ≥ 2 peripheral neuropathy

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: TED; SOC; Syringe; Needle
Intervention description: 0.05 mg/kg SC injection once daily.; Standard safety assessments and adjustments in nutritional support.; Teduglutide will be administered using syringe.; Teduglutide will be administered using needle.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Healthy volunteers: No

Summary:

      This study will follow participants who completed the TED-C14-006 study. The purpose of this
      study is to evaluate the long-term safety and efficacy of teduglutide in pediatric
      participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide
      treatment to eligible participants, regardless of treatment received in TED-C14-006 or
      SHP633-301.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant provides written informed consent (participant, parent or legal guardian
             and, as appropriate, informed assent) to participate in the study before completing
             any study-related procedures.

          2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in
             the standard of care treatment arms). Participants are considered to have completed
             SHP633-301 if they completed study assessments through week 24.

          3. Participant understands and is willing and able to fully adhere to study requirements
             as defined in this protocol.

        Exclusion Criteria:

        1. There are no exclusion criteria for this study.
A Long-Term Safety Study of Tenapanor for the Treatment of IBS-C
Condition: Constipation Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Constipation
Intervention: Tenapanor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 312.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This phase 3, open label study will evaluate the safety of tenapanor 50 mg BID in subjects
      with constipation-predominant irritable bowel syndrome (IBS-C) defined by the ROME III
      criteria. Subjects who have completed either TEN-01-301 (16 weeks) or TEN-01-302 (26 weeks)
      studies may be enrolled. Subjects will take tenapanor for approximately 52-55 weeks total
      based on previous protocol and this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects completed all 16 weeks of TEN-01-301 or all 26 weeks of TEN-01-302

          -  Subject demonstrated adequate compliance with the study procedures during either the
             TEN-01-301 or TEN-01-302 studies

          -  Females must be of non-childbearing potential; If of child-bearing potential, must
             have negative pregnancy test and confirm the use of one of the appropriate means of
             contraception

          -  Males must agree to use appropriate methods of barrier contraception or have
             documented surgical sterilization

        Exclusion Criteria:

          -  Subject has been withdrawn or discontinued prematurely from either TEN-01-301 or
             TEN-01-302

          -  The subject reports using any prohibited medication and is not willing to abide by the
             restrictions for intake

          -  Pregnant or lactating women
Mirena Extension Trial
Condition: Contraception
MeSH terms: Menorrhagia
Intervention: Levonorgestrel IUS (Mirena, BAY86-5028)
Intervention description: Levonorgestrel (LNG) intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg levonorgestrel per day.
Intervention MeSH terms: Levonorgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 364.0
Sex: Female
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: Birth Control; Heavy menstrual bleeding

Summary:

      The study is performed to assess if Mirena is effective and safe as a birth control method
      beyond 5 years of use. Further the menstrual blood loss (in women that had Mirena inserted
      for the indication heavy menstrual bleeding [HMB]) and safety will be assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed and dated informed consent

          -  Women, 18 to 35 years of age at the time of screening (visit 1) who are currently
             using Mirena for contraception or for contraception and heavy menstrual bleeding. The
             duration of use of the current Mirena has to be at least 4 years 6 months at the start
             of screening phase but not more than 5 years at visit 2 and the woman is willing to
             continue with its use and has a continuing need for contraception.

          -  Normal or clinically insignificant cervical smear not requiring further follow up

        Exclusion Criteria:

          -  Menopausal symptoms with Follicle-stimulating hormone>30 mIU/ml

          -  Pregnancy or suspicion of pregnancy

          -  Uterine bleeding of unknown etiology

          -  Untreated acute cervicitis or vaginitis or other lower genital tract infections

          -  Increased susceptibility to pelvic infection

          -  Acute pelvic inflammatory disease (PID) or a history of PID unless successfully
             treated and which, in the investigator's opinion, has not negatively affected
             subject's fertility

          -  Congenital or acquired uterine anomaly if it distorts the uterine cavity

          -  History of, diagnosed or suspected genital or other malignancy and untreated cervical
             dysplasia

          -  Any active acute liver disease or liver tumor (benign or malignant)

          -  Clinically significant endometrial polyp(s)
Study of Single Agent Pembrolizumab (MK-3475) Versus Single Agent Chemotherapy for Metastatic Triple Negative Breast Cancer (MK-3475-119/KEYNOTE-119)
Condition: Metastatic Triple Negative Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: pembrolizumab; capecitabine; eribulin; gemcitabine; vinorelbine
Intervention MeSH terms: Gemcitabine; Capecitabine; Pembrolizumab; Vinorelbine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 622.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Programmed Cell Death-1 (PD1, PD-1); Programmed Death-Ligand 1 (PDL1, PD-L1)

Summary:

      In this study, participants with metastatic triple negative breast cancer (mTNBC) will be
      randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy
      chosen by the treating physician (Treatment of Physician's Choice, TPC) in accordance with
      local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine,
      or vinorelbine. The primary study hypothesis is that pembrolizumab extends overall survival
      compared to TPC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Centrally confirmed Stage IV/M1 mTNBC

          -  Newly obtained tumor biopsy from metastatic site

          -  Central determination of programmed cell death ligand 1 (PD-L1) tumor status

          -  Received either one or two prior systemic treatments for metastatic breast cancer and
             have documented disease progression on or after the most recent therapy

          -  Previously treated with an anthracycline and/or taxane in the neoadjuvant/adjuvant or
             metastatic setting

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 10 days
             prior to study start

          -  Adequate organ function

        Exclusion Criteria:

          -  Participation in another clinical trial within 4 weeks

          -  Monoclonal antibody (mAb) for direct anti-neoplastic treatment within 4 weeks

          -  Chemotherapy, targeted small molecule therapy, or radiation therapy within at least 2
             weeks

          -  Active autoimmune disease that required systemic treatment in the past 2 years

          -  Diagnosed with immunodeficiency or receiving systemic steroid therapy or another form
             of immunosuppressive therapy within 7 days

          -  Known additional malignancy that required treatment or progressed in last 5 years

          -  Known active brain metastases and/or carcinomatous meningitis

          -  Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-ligand-1
             (anti-PD-L1), anti-PD-L2 agent or with an agent directed to another co-inhibitory
             T-cell receptor (e.g. cytotoxic T-lymphocyte associated protein 4 [CTLA-4], OX-40,
             CD137) or previously participated in any pembrolizumab (MK-3475) clinical studies
Topical Ruxolitinib Evaluation in Vitiligo Study 2 (TRuE-V2)
Condition: Non-segmental Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib cream; Vehicle
Intervention description: Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vitiligo; non-segmental; JAK inhibitor

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in
      adolescent and adult participants with non-segmental vitiligo for whom total body involved
      vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5%
             BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body
             vitiligo area (facial and nonfacial) not exceeding 10% BSA.

          -  Agree to discontinue all agents used to treat vitiligo from screening through the
             final safety follow-up visit. Over-the-counter preparations deemed acceptable by the
             investigator and camouflage makeups are permitted.

          -  Must be willing to take appropriate contraceptive measures to avoid pregnancy or
             fathering a child for the duration of study participation.

        Key Exclusion Criteria:

          -  No pigmented hair within any of the vitiligo areas on the face.

          -  Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or
             other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy,
             postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus,
             chemical leukoderma, and tinea versicolor).

          -  Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo
             or other pigmented areas.

          -  Use of protocol-defined treatments within the indicated washout period before
             baseline.
A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects With Non-Infectious Uveitis of the Posterior Segment of the Eye Who Have Participated in the SAKURA Development Program
Condition: Non-Infectious Uveitis of the Posterior Segment of the Eye
MeSH terms: Uveitis
Intervention: DE-109 440 μg
Intervention description: Medium Dose
Intervention MeSH terms: Sirolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this extension study is to evaluate the long-term safety of treatment with
      DE-109 (440 μg) in subjects with non-infectious uveitis of the posterior segment of the eye
      who have participated in the SAKURA development program.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participated in the SAKURA study

          2. Received clinical benefit from treatment in the SAKURA study

          3. Ability to sign informed consent and attend all study visits

        Exclusion Criteria:

          1. Uveitis of infectious etiology

          2. Implanted device

          3. Suspected or confirmed central nervous system or ocular lymphoma

          4. Uncontrolled glaucoma

          5. Significant ocular disease

          6. Intravitreal injections in the past 60 days

          7. Intraocular surgery or treatment

          8. Ocular or periocular infection

          9. History of herpetic infection

         10. Toxoplasmosis or toxoplasmosis scar

         11. Ocular malignancy

         12. Vitrectomy

         13. Allergy or hypersensitivity to study drug

         14. Participation in other uveitis device clinical trials within 30 days

         15. Any recent systemic condition/infection

         16. Immunosuppressive therapy or immunocomprimised

         17. Cytomegalovirus infection

         18. Malignancy in remission

         19. Females who are pregnant or lactating and who are not using adequate contraceptive

         20. Medical marijuana or illegal drug use

         21. Systemic saroidosis

         22. Therapeutic radiation to the head or neck