bioihbjkbjnl/mcl2 huggingface dataset:
A Study of ALKS 5461 for the Treatment of Major Depressive Disorder (MDD) - FORWARD-5 Study
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461; Placebo
Intervention description: Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant); Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Major depressive disorder (MDD); depression; Alkermes; ALKS 5461; samidorphan

Summary:

      This study will evaluate the efficacy and safety of ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a BMI of 18.0 to 40.0 kg/m2, inclusive

          -  Agree to use an acceptable method of contraception for the duration of the study

          -  Have an MDD primary diagnosis

          -  Have no more than 2 inadequate responses to antidepressant therapy (ADT) in the
             current Major Depressive Episode (MDE)

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Have a current primary Axis-I disorder other than MDD

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 2 years or received
             more than one course of electroconvulsive treatment during their lifetime

          -  Have attempted suicide within the past 2 years

          -  Have a positive test for drugs of abuse

          -  Are pregnant, planning to become pregnant, or breastfeeding

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation within 60 days

          -  Additional criteria may apply
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Capecitabine; Oxaliplatin; Leucovorin (LV); 5-Fluorouracil (5-FU)
Intervention description: 1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.; 130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.; Administered by one of two regimens, as specified in the arm description.; Administered by one of two regimens, as specified in the arm description.
Intervention MeSH terms: Leucovorin; Capecitabine; Fluorouracil; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1886.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus
      Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery
      for colon cancer and no previous chemotherapy. Patients will be randomized to receive either
      1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or
      2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment
      is until disease progression and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)

          -  Complete tumor resection; Patients operated with curative intent and with no
             macroscopic or microscopic evidence for remaining tumor who can be randomized to
             either treatment arm within 8 weeks after surgery. As this is an adjuvant trial
             patients should never have had any evidence of metastatic disease (including presence
             of tumor cells in the ascites).

          -  Have a life expectancy of at least 5 years

        Exclusion Criteria:

          -  Pregnant or lactating women

          -  Sexually active males and females (of childbearing potential) unwilling to practice
             contraception during the study

          -  Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently
             treated colon cancer

          -  Patients who have not completely recovered from surgery
A Phase III Study on the Safety, Pharmacokinetics and Efficacy of Coagulation Factor VIIa
Condition: Hemophilia A With Inhibitors; Hemophilia B With Inhibitors
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Coagulation FVIIa (Recombinant)
Intervention description: A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the safety, efficacy and pharmacokinetics of 2 separate
      dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the
      treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII
      or IX in 12 patients ( birth to <6 years old), and 12 patients (≥6 years old to <12 years
      old).
    

Eligibility criteria:

        Inclusion Criteria:

          -  be male with a diagnosis of congenital hemophilia A or B of any severity

          -  have one of the following:

          -  a positive inhibitor test BU ≥5, OR

          -  a Bethesda Unit (BU) <5 but expected to have a high anamnestic response to FVIII or
             FIX, as demonstrated from the patient's medical history, precluding the use of factor
             VIII or IX products to treat bleeding episodes, OR

          -  a BU <5 but expected to be refractory to increased dosing of FVIII or FIX, as
             demonstrated from the patient's medical history, precluding the use of factor VIII or
             IX products to treat bleeding episodes

          -  be aged from birth to <12 years old

          -  have experienced at least 3 bleeding episodes of any severity in the past 6 months

          -  parents or legal guardians must be capable of understanding and be willing to comply
             with the conditions of the protocol

          -  parents or legal guardians must have read, understood, and provided written informed
             consent

        Exclusion Criteria:

          -  have any coagulation disorder other than hemophilia A or B

          -  be immunosuppressed (i.e., the patient may not be receiving systemic immunosuppressive
             medication; cluster of differentiation 4 (CD4) counts at screening must be >200/µL)

          -  have a known allergy or hypersensitivity to rabbits

          -  have platelet count <100,000/mL

          -  have had a major surgical procedure (e.g. orthopedic, abdominal) within 1 month prior
             to first administration of study drug

          -  have received an investigational drug within 30 days of first study drug
             administration, or be expected to receive such drug during participation in this study
The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life
Condition: Quality of Life; Cervical Abrasion
Intervention: Photac-fil; Biodentine
Intervention description: Application of a tooth colored filling in a non-cavitated dental lesion.; Application of a white colored filling in a non-cavitated dental lesion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One group will be treated with a tooth colored filling that will be placed near the gum line. The second group will be treated with a white colored filling that will be placed near the gum line.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The study will compare two different dental materials on dental lesions near the gum line
      that cause chronic pain on oral health related quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females age 18-64

          -  Chief complaint associated with pain from cold or hot

          -  Chronic sensitivity associated with supragingival lesions

          -  Pain not associated with decay

          -  Fluent in English and able to read English at a 6th grade level

          -  Pulpal response <40 via pulp tester

          -  Active salivary flow from palpation of parotid and submandibular glands

          -  Patients self reporting pain over 6/10 in the past week and/or the past 2 months

        Exclusion Criteria:

          -  Pregnant women

          -  Patients taking benzodiazepines, narcotics and multiple antidepressants for pain
             management not associated with the oral cavity

          -  Unexplained dry mouth

          -  Patients taking two or more medications associated with dry mouth

          -  Pulpal response >40 via pulp tester

          -  Patients requiring treatment for more than 5 decayed sites, periodontal disease and
             root canal therapy

          -  Complicated medical history (>4 concurrent treatment for systemic diseases)

          -  Lesion >1mm below the gum line
Efficacy and Safety Trial of Flexible Doses of Oral Ziprasidone in Children and Adolescents With Bipolar I Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: placebo oral capsules; ziprasidone oral capsules
Intervention description: Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.; Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 171.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Bipolar I Disorder (current or most recent episode manic). Children and adolescents aged 10 to 17 years.

Summary:

      The purpose of this study is to determine if ziprasidone is safe and effective for the
      treatment of children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM V criteria for Bipolar I disorder (manic or mixed); age 10 - 17 years.

        Exclusion Criteria:

          -  Imminent risk of suicide or homicide, as judged by the site investigator; any history
             of serious or unstable medical illness, including risk for QT prolongation.
Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Ravulizumab OBDS; Ravulizumab
Intervention description: The ravulizumab OBDS is a biological-device combination product consisting of a prefilled cartridge containing ravulizumab SC and an on-body injector.; Administered by IV infusion. Ravulizumab IV doses will be based on participant body weight.
Intervention MeSH terms: Ravulizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH

Summary:

      The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab
      administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously
      administered ravulizumab in adult participants with PNH who are clinically stable on
      eculizumab for at least 6 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥18 years of age

          -  Treated with eculizumab for PNH for at least 3 months prior to Day 1

          -  LDH level ≤1.5 × upper limit of normal (ULN) at screening

          -  PNH diagnosis confirmed by documented high-sensitivity flow cytometry.

          -  Documented meningococcal vaccination not more than 3 years prior to, or at the time
             of, initiating study treatment.

          -  Body weight ≥40 to <100 kilogram (kg)

          -  Female participants of childbearing potential must use highly effective contraception
             starting at screening and continuing until at least 8 months after the last dose of
             ravulizumab.

          -  Willing and able to give written informed consent and comply with study visit
             schedule.

        Exclusion Criteria:

          -  LDH level ≤ 2 × upper limit of normal (ULN) within 3 months prior to Day 1

          -  History of bone marrow transplantation.

          -  History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease
             that, in the opinion of the Investigator or Sponsor, would preclude participation.

          -  Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal
             bleed, severe congestive heart failure, anticipated need for major surgery within 6
             months of randomization, coexisting chronic anemia unrelated to PNH).

          -  Females who are pregnant, breastfeeding or who have a positive pregnancy test at
             screening or Day 1.

          -  Participation in another interventional clinical study or use of any experimental
             therapy within 30 days before initiation of study drug on Day 1 in this study or
             within 5 half-lives of that investigational product, whichever is greater.
Telotristat Etiprate for Carcinoid Syndrome Therapy
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate; Placebo
Intervention description: Telotristat etiprate tablets; Placebo-matching telotristat etiprate tablets
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 76.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the effect of telotristat etiprate versus placebo on
      the incidence of treatment-emergent adverse events and on 5-hydroxyindoleacetic acid (5-HIAA)
      levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients ≥ 18 years of age

          -  All patients of reproductive potential must agree to use an adequate method of
             contraception during the study and for 12 weeks after the Follow-up visit.

          -  Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor

          -  Documented history of carcinoid syndrome

          -  Patient is able and willing to provide written informed consent prior to participation

        Exclusion Criteria:

          -  Presence of diarrhea attributed to any condition other than carcinoid syndrome.

          -  Presence of 12 or more watery bowel movements per day

          -  Positive stool examination for enteric pathogens, pathogenic ova or parasites, of
             Clostridium difficile at Screening

          -  Karnofsky Performance Status ≤ 60%

          -  Presence of any clinically significant laboratory, medical history, or physical
             examination findings deemed unacceptable by the Investigator

          -  A history of short bowel syndrome

          -  History of constipation within 2 years of Screening

          -  Life expectancy < 12 months from Screening
A Study to Assess if Mirikizumab is Effective and Safe Compared to Secukinumab and Placebo in Moderate to Severe Plaque Psoriasis (OASIS-2)
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: Mirikizumab; Placebo; Secukinumab
Intervention description: Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Mirikizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interleukin-23 (IL-23)

Summary:

      The reason for this study is to see how effective and safe mirikizumab is compared to
      secukinumab and placebo for moderate to severe plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must have chronic plaque psoriasis for at least 6 months.

        Exclusion Criteria:

          -  Participant must not be breastfeeding or nursing woman.

          -  Participant must not have had serious, opportunistic, or chronic/recurring infection
             within 3 months.

          -  Participant must not have received a Bacillus Calmette-Guerin (BCG) vaccination within
             12 months or received live vaccine(s) (including attenuated live vaccines) within 12
             weeks of baseline or intend to receive either during the study.

          -  Participant must not have any other skin conditions (excluding psoriasis).

          -  Participant must not have previous exposure to Cosentyx and any other biologic therapy
             targeting IL-17 (including Taltz).

          -  Participant must not have received anti-tumor necrosis factor (TNF) biologics within 8
             weeks.

          -  Participant must not have previous exposure to any biologic therapy targeting IL-23
             (including Stelara).
Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: efanesoctocog alfa (BIVV001)
Intervention description: Pharmaceutical form: solution for injection Route of administration: IV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Male
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      - To evaluate the safety of BIVV001 in previously treated pediatric participants with
      hemophilia A.

      Secondary Objectives:

        -  To evaluate the efficacy of BIVV001 as a prophylaxis treatment.

        -  To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.

        -  To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes.

        -  To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.

        -  To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes.

        -  To evaluate the efficacy of BIVV001 for perioperative management.

        -  To evaluate the safety and tolerability of BIVV001 treatment.

        -  To assess the pharmacokinetics (PK) of BIVV001.
    

Eligibility criteria:

        Inclusion criteria :

          -  Participant must be younger than 12 years of age, at the time of signing the informed
             consent.

          -  Severe hemophilia A defined as <1 international units per deciliter (IU/dL) (<1
             percent [%]) endogenous Factor VIII (FVIII) as documented either by central laboratory
             testing at Screening or in historical medical records from a clinical laboratory
             demonstrating <1% FVIII coagulant activity (FVIII:C) or a documented genotype known to
             produce severe hemophilia A.

          -  Previous treatment for hemophilia A (prophylaxis or on-demand) with any recombinant
             and/or plasma-derived FVIII, or cryoprecipitate for at least 150 exposure days (EDs)
             for participants aged 6 to <12 years and above 50 EDs for participants aged <6 years.

          -  Weight above or equal to 10 kg.

        Exclusion criteria:

          -  History of hypersensitivity or anaphylaxis associated with any FVIII product.

          -  History of a positive inhibitor (to FVIII) test defined as greater than or equal to
             (>=) 0.6 Bethesda units (BU/mL), or any value greater than or equal to the lower
             sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7
             and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII
             administrations. Family history of inhibitors would not exclude the participant.

          -  Positive inhibitor test result, defined as >=0.6 BU/mL at Screening.

        The above information was not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.