bioihbjkbjnl/mcl2 huggingface dataset:
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: placebo; Elagolix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 815.0
Sex: Female
Minimum age: 18 Years
Maximum age: 49 Years
Healthy volunteers: No
Keywords: Non-Menstrual Pelvic Pain (NMPP); Dysmenorrhea (DYS); Elagolix; Endometriosis Associated Pain; Gonadotropin-Releasing Hormone Antagonist

Summary:

      A randomized study evaluating the safety and efficacy of elagolix in the management of
      moderate to severe endometriosis-associated pain in adult premenopausal female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Premenopausal female, between 18 and 49 years of age, inclusive, at the time of
             signing consent.

          2. Clinical diagnosis of endometriosis (laparoscopy or laparotomy) performed within 10
             years of entry into the Washout Period.

          3. Agrees to use required birth control methods during the entire length of participation
             in the study.

          4. Subject has a Composite Pelvic Signs and Symptoms Score total score of 6 or greater at
             Screening with a score of at least 2 for dysmenorrhea AND at least 2 for non-menstrual
             pelvic pain.

          5. Subjects must have at least two regular menstrual cycles with an interval of 24-38
             days within the Screening Period, prior to Day 1.

        Exclusion Criteria:

          1. Subject is pregnant or breast feeding or is planning a pregnancy within the next 24
             months or is less than 6 months postpartum, post-abortion, or post-pregnancy at the
             time of entry into the Screening Period.

          2. Subject has a history of previous non-response to gonadotropin-releasing hormone
             (GnRH) agonists, GnRH antagonists, Depot medroxyprogesterone acetate, or aromatase
             inhibitors as assessed by subject report of no improvement in dysmenorrhea or
             non-menstrual pelvic pain.

          3. Subject has chronic pelvic pain that is not caused by endometriosis that requires
             chronic analgesic or other chronic therapy, or that would interfere with the
             assessment of endometriosis related pain.

          4. Clinically significant gynecologic condition identified on Screening transvaginal
             ultrasound or endometrial biopsy.

          5. Subject has a history of osteoporosis or other metabolic bone disease.

          6. Subject has a current history of undiagnosed abnormal uterine bleeding.
Flexitouch® Home Maintenance Therapy or Standard Home Maintenance Therapy in Treating Patients With Lower-Extremity Lymphedema Caused by Treatment for Cervical Cancer, Vulvar Cancer, or Endometrial Cancer
Condition: Lymphedema; Stage 0 Cervical Cancer; Stage 0 Uterine Corpus Cancer; Stage 0 Vulvar Cancer; Stage I Uterine Corpus Cancer; Stage I Vulvar Cancer; Stage IA Cervical Cancer; Stage IB Cervical Cancer; Stage II Uterine Corpus Cancer; Stage II Vulvar Cancer; Stage IIA Cervical Cancer; Stage IIB Cervical Cancer; Stage III Cervical Cancer; Stage III Uterine Corpus Cancer; Stage III Vulvar Cancer; Stage IV Uterine Corpus Cancer; Stage IVA Cervical Cancer; Stage IVB Cervical Cancer; Stage IVB Vulvar Cancer
MeSH terms: Uterine Cervical Neoplasms; Vulvar Neoplasms; Lymphedema
Intervention: Management of Therapy Complications; Management of Therapy Complications; Quality-of-Life Assessment
Intervention description: Receive standard home maintenance therapy and perform self-manual lymphatic drainage; Receive Flexitouch home maintenance therapy; Ancillary studies
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial is studying Flexitouch® home maintenance therapy to see how
      well it works compared with standard home maintenance therapy in treating patients with
      lower-extremity lymphedema caused by treatment for cervical cancer, vulvar cancer, or
      endometrial cancer. Flexitouch® home maintenance therapy may lessen lower-extremity
      lymphedema caused by treatment for gynecologic cancer. It is not yet known whether the
      Flexitouch® system is more effective than standard home maintenance therapy in treating
      lymphedema.
    

Eligibility criteria:

        Criteria:

          -  Has lower-extremity lymphedema on one side of the body caused by surgery,
             chemotherapy, and/or radiation therapy.

          -  At least 6 months since clinic therapy for lower-extremity lymphedema

          -  Is within 3 years from finishing cancer treatment

          -  No active or recurrent cancer

          -  More than 3 months since cancer treatment
A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Cisplatin; Vinorelbine; Gemcitabine; Docetaxel; Pemetrexed; Carboplatin; Paclitaxel; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; This arm is closed and no longer enrolling patients.
Intervention MeSH terms: Paclitaxel; Vinorelbine; Docetaxel; Carboplatin; Gemcitabine; Nivolumab; Pemetrexed; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 505.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and
      chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus
      ipilimumab's safety and effectiveness in treating resectable NSCLC.

      This study has multiple primary endpoints.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue

          -  Lung function capacity capable of tolerating the proposed lung surgery

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

          -  Available tissue of primary lung tumor

        Exclusion Criteria:

          -  Presence of locally advanced, inoperable or metastatic disease

          -  Participants with active, known or suspected autoimmune disease

          -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as
             checkpoint inhibitors)

        Other protocol defined inclusion/exclusion criteria apply
Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch)
Condition: Pruritus; Prurigo Nodularis; Atopic Dermatitis; Psoriasis
MeSH terms: Psoriasis; Dermatitis; Pruritus; Prurigo
Intervention: 5 mg Serlopitant Tablets
Intervention description: Serlopitant Tablets
Intervention MeSH terms: Serlopitant
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 558.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study of the long term safety of serlopitant for the treatment of pruritus in adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age 18 years or older at consent.

          -  Pruritus associated with prurigo nodularis, atopic dermatitis, or psoriasis.

          -  Female subjects of childbearing potential must be willing to practice highly effective
             contraception until 5 weeks after last dose of study drug.

          -  Willing and able to comply with study visits and study related requirements including
             providing written informed consent.

        Exclusion Criteria:

          -  Malignancy within 5 years prior to enrollment (exception for non-melanoma cutaneous
             malignancies).

          -  Any known major psychiatric diagnosis, such as major depressive disorder, bipolar
             disorder, schizophrenia, psychotic disorder, intellectual disability, severe alcohol
             use disorder, which may confound the assessment of serlopitant safety or efficacy, or
             interfere with the subject's ability to comply with protocol-mandated activities,
             within 3 years prior to enrollment.

          -  Untreated or inadequately treated thyroid, adrenal, or pituitary nodules or disease,
             or history of thyroid malignancy; or the prescense of any medical condition or
             disability, that could interfere with the assessment of safety in this study or
             compromise the safety of the subject.

          -  Investigational therapy within 4 weeks or 5-half-lives prior to enrollment (whichever
             is longer) or expected participation in another clinical study involving an
             investigational product or device during the subject's participation in this study.

          -  Treatment with other neurokinin-1 receptor (NK1-R) antagonists (e.g., aprepitant,
             fosaprepitant, rolapitant) within 4 weeks.

          -  Treatment with strong cytochrome P450 3A4 inhibitors within 4 weeks.

          -  Currently pregnant or breastfeeding or planning to become pregnant during the study.
A Multicenter Trial to Investigate the Efficacy and Safety of Tolvaptan in Patients With Hyponatremia in SIADH
Condition: Syndrome of Inappropriate Antidiuretic Hormone Secretion
MeSH terms: Inappropriate ADH Syndrome; Diabetes Insipidus; Hyponatremia; Syndrome
Intervention: Tolvaptan Oral Tablet
Intervention description: Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objective of this study is to investigate the efficacy and safety of tolvaptan based on
      the change in serum sodium concentration following administration of tolvaptan oral tablets
      at 7.5 to 60 mg/day for up to 30 days in patients with hyponatremia in the SIADH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a definite diagnosis of SIADH in reference to "Diagnostic and Treatment
             Manual of the Hypersecretion of Vasopressin (SIADH), Revised in 2011"

          -  Subjects who have been on fluid restriction for at least 7 consecutive days at the
             time of informed consent and who are showing no improvement of hyponatremia at the
             time of the screening examination

        Exclusion Criteria:

          -  Subjects who have transient hyponatremia induced by drug administration

          -  Subjects who are unable to sense thirst or who have difficulty with fluid intake

          -  Subjects with urinary tract obstruction

          -  Subjects who have participated in any other clinical trial within 30 days prior to
             informed consent

          -  Subjects with serum sodium concentration of <120 mEq/L associated with neurologic
             impairment, including apathy, confusion, or seizures
Colloids in Pediatric Cardiac Surgery: Comparison Between a Balanced and a Non-balanced Colloid
Condition: Cardiac Surgery; Cardiopulmonary Bypass
Intervention: Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution; Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride
Intervention description: Peri-operative fluid replacement therapy (max 40ml/kg/day); Peri-operative fluid replacement therapy (max 40ml/kg/day)
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 88.0
Sex: All
Minimum age: 28 Days
Maximum age: 3 Years
Healthy volunteers: No

Summary:

      This study will compare the clinical efficacy and safety of Volulyte® and Voluven® during
      elective open-heart surgery in pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 28 days to 3 years old

          -  Planned cardiac surgery with cardiopulmonary by-pass

          -  signed informed consent

        Exclusion Criteria:

          -  Moribund patients (ASA 5)

          -  Jehovah Witnesses

          -  Pre-operative coagulation disorders

          -  Pre-operative renal insufficiency

          -  Pre-operative hepatic disorders

          -  Intra-cranial hemorrhage

          -  hypernatremia
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
Condition: Primary Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Intervention: Rozanolixizumab
Intervention description: Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Period.
Intervention MeSH terms: Rozanolixizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ITP; UCB7665; Rozanolixizumab; Primary immune thrombocytopenia

Summary:

      The purpose of this study is to assess the long-term safety, tolerability and clinical
      efficacy of treatment with rozanolixizumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Study participant completed TP0003 [NCT04200456] or TP0006 [NCT04224688] until Visit
             27 (Week 25) and, in the opinion of the investigator, has been compliant with the
             TP0003 or TP0006 study assessments

          -  The study participant is considered reliable and capable of adhering to the protocol,
             visit schedule, or medication intake according to the judgment of the investigator

          -  Study participants may be male or female:

               1. A male participant must agree to use contraception during the Treatment Period
                  and for at least 3 months after the final dose of study treatment and refrain
                  from donating sperm during this period

               2. A female participant is eligible to participate if she is not pregnant as
                  confirmed by a negative urine pregnancy test and not planning to get pregnant
                  during the participation in the study, not breastfeeding, and at least one of the
                  following conditions applies:

        Not a woman of childbearing potential (WOCBP) OR A WOCBP who agrees to follow the
        contraceptive guidance during the Treatment Period and for at least 3 months after the
        final dose of study treatment

        Exclusion Criteria:

          -  Study participant has any ongoing investigational medicinal product (IMP)-related
             serious adverse event (SAE) or ongoing severe IMP-related treatment-emergent adverse
             event (TEAE) experienced during TP0003 or TP0006

          -  Study participant has, at last available assessment of TP0003 or TP0006, 3.0x upper
             limit of normal (ULN) of any of the following: alanine aminotransferase (ALT),
             aspartate aminotransferase (AST), or alkaline phosphatase (ALP)
A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis
Condition: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis, Psoriatic; Psoriasis
Intervention: Bimekizumab; Placebo
Intervention description: Bimekizumab will be provided at pre-specified time intervals.; Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis

Summary:

      Phase 3 study to compare the efficacy of bimekizumab versus placebo in the treatment of
      subjects with moderate to severe chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 18 years of age

          -  Chronic plaque psoriasis (PSO) for at least 6 months prior to the Screening Visit

          -  Psoriasis Area Severity Index (PASI) >=12 and body surface area (BSA) affected by PSO
             >=10% and Investigator's Global Assessment (IGA) score >=3 on a 5-point scale

          -  Subject is a candidate for systemic PSO therapy and/or phototherapy

          -  Female subject of child bearing potential must be willing to use highly effective
             method of contraception

        Exclusion Criteria:

          -  Subject has an active infection (except common cold), a recent serious infection, or a
             history of opportunistic, recurrent, or chronic infections

          -  Subject has concurrent acute or chronic viral hepatitis B or C or human
             immunodeficiency virus (HIV) infection

          -  Subject has known tuberculosis (TB) infection, is at high risk of acquiring TB
             infection, or has current or history of nontuberculous mycobacterium (NTMB) infection

          -  Subject has any other condition, including medical or psychiatric, which, in the
             Investigator's judgment, would make the subject unsuitable for inclusion in the study

          -  Presence of active suicidal ideation or positive suicide behavior

          -  Presence of moderately severe major depression or severe major depression

          -  Subject has any active malignancy or history of malignancy within 5 years prior to the
             Screening Visit EXCEPT treated and considered cured cutaneous squamous or basal cell
             carcinoma, or in situ cervical cancer
Long-term Study of Efficacy/Safety of Adapalene/Benzoyl Peroxide Topical Gel in Acne Vulgaris Subjects
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Adapalene/Benzoyl Peroxide
Intervention description: Adapalene 0.1 percent (%) [weight by weight (W/W)] and benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening.
Intervention MeSH terms: Adapalene; Adapalene, Benzoyl Peroxide Drug Combination; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 452.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acne Vulgaris; Adapalene; Benzoyl Peroxide

Summary:

      This was a multi-center, open-label, non-comparative study that evaluated the long-term
      safety and efficacy profile of Adapalene/Benzoyl Peroxide Gel.

      Subjects were evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.

      Safety was evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability
      Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing
      (hematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations.
      Efficacy was evaluated by analysis of Percent Change from Baseline in Inflammatory,
      Noninflammatory, and Total Lesion Counts, and by the Subject's Assessment of Acne.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of acne vulgaris with facial involvement.

          -  A minimum of 20 but not more than 50 Inflammatory lesions.

          -  A minimum of 30 but not more than 100 Noninflammatory lesions.

        Exclusion Criteria:

          -  Subjects with presence of nodules or cysts.

          -  Acne conglobate, acne fulminans, secondary acne, or severe acne.

          -  Underlying diseases that required the use of interfering topical or systemic therapy.

          -  Use of prohibited medications prior to the study unless appropriate washout period was
             documented.
SVT-15652 Otic Solution for the Treatment of Otomycosis.
Condition: Otomycosis
MeSH terms: Otomycosis
Intervention: SVT-15652; Placebo
Intervention description: 1 vial twice daily; 1 vial twice daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in
      patients suffering from Otomycosis. This study will compare the efficacy and safety of
      SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14
      days.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  At least 18 years of age

          -  Clinical diagnosis of otomycosis in one or both ears, where topical treatment is
             indicated.

          -  Signs/symptoms of pruritus, otalgia and ear fullness.

          -  Debris or drainage clinically consistent with fungal infection.

        Main Exclusion Criteria:

          -  Known bacterial otitis externa or malignant otitis externa.

          -  Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.

          -  Structural ear anomalies which may difficult the evaluation of the therapeutic
             response.

          -  Uncontrolled diabetes mellitus.

          -  Any infection requiring systemic antimicrobial or systemic antifungal therapy.

          -  Concomitant medicines that may interfere with the study evaluations.