bioihbjkbjnl/mcl2 huggingface dataset:
The VITAL Amyloidosis Study, a Global Phase 3, Efficacy and Safety Study of NEOD001 in Patients With AL Amyloidosis
Condition: Primary Systemic (AL) Amyloidosis
MeSH terms: Amyloidosis
Intervention: NEOD001; Placebo
Intervention description: NEOD001, is a humanized immunoglobulin G1 monoclonal antibody, which specifically targets misfolded light chain aggregates and amyloid deposits. NEOD001 is proposed for use to target the misfolded light chain protein in subjects with AL amyloidosis.; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 260.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm
      efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will
      remain on-study until study completion, which will occur when all primary endpoint events
      (all-cause mortality or cardiac hospitalizations) have been reached.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age ≥ 18 years

          2. Newly diagnosed, AL amyloidosis treatment naïve

          3. Bone marrow consistent with plasma cell dyscrasia

          4. Confirmed diagnosis of AL amyloidosis

          5. Cardiac involvement

          6. Planned first-line chemotherapy contains a proteasome-inhibiting agent administered
             weekly

          7. Adequate bone marrow reserve, hepatic and renal function

        Key Exclusion Criteria:

          1. Non-AL amyloidosis

          2. Meets diagnostic criteria for symptomatic multiple myeloma

          3. Subject is eligible for and plans to undergo ASCT

          4. History of Grade ≥ 3 infusion-associated AEs or hypersensitivity to another monoclonal
             antibody, or known hypersensitivity to diphenhydramine or acetaminophen
A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in
      participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414)
      or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants
      will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core
             study on SC or IV TCZ and, based on the Investigator's judgment, may continue to
             benefit from TCZ treatment in this study investigating the SC formulation

          -  Receiving treatment on an outpatient basis

          -  Females of childbearing potential and males with female partners of childbearing
             potential must agree to use reliable means of contraception as defined by protocol

        Exclusion Criteria:

          -  Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) core studies
             for any reason

          -  History of severe allergic or anaphylactic reactions to human, humanized, or murine
             monoclonal antibodies

          -  Evidence of serious uncontrolled concomitant disease or disorder

          -  Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,
             or other infections

          -  Any major episode of infection requiring hospitalization or treatment with IV
             antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of
             Screening

          -  History of or currently active primary or secondary immunodeficiency

          -  Oral corticosteroids at greater than (>) 10 mg per day prednisone or equivalent, or
             non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose

          -  Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline

          -  Treatment with any investigational or commercially available biologic
             disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between
             completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and
             enrollment in the long-term extension study

          -  Pregnant or breastfeeding women

          -  History of alcohol, drug, or chemical abuse within 1 year prior to Screening
Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction
Condition: Smokeless Tobacco Use
MeSH terms: Behavior, Addictive
Intervention: Nicotine Lozenges; Placebo lozenge
Intervention description: Nicotine lozenges, 4 mg; Placebo lozenge
Intervention MeSH terms: Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tobacco use disorder; Tobacco cessation

Summary:

      This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The
      independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching
      placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6
      months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or
      matching placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  are at least 18 years of age;

          -  report smokeless tobacco (ST) as their primary tobacco of use;

          -  have used ST daily for the past 6 months;

          -  are in general good health (determined by medical history and screening physical
             examination);

          -  have been provided with, understand, and have signed the informed consent.
Aripiprazole Open-Label, Safety and Tolerability Study
Condition: Schizophrenia; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder
Intervention: Aripiprazole
Intervention description: 2 to 30 mg/day orally (2, 5, 10, 15, 20, 25, or 30 mg/day); tablets in strengths of 2, 5, 10, and 15 mg were used to achieve desired doses
Intervention MeSH terms: Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 325.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Open Label; Aripiprazole; Bipolar I Disorder, Manic or Mixed Episode

Summary:

      The purpose of this study is to test the long-term safety and tolerability of aripiprazole in
      adolescent patients with schizophrenia, and child and adolescent patients with bipolar I
      disorder, manic or mixed episode.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adolescent patients with schizophrenia, or child and adolescent patients with bipolar
             I disorder, manic or mixed episode

        Exclusion Criteria:

          -  Patients with a co-morbid serious, uncontrolled systemic illness

          -  Patients with a significant risk of committing suicide
Research Study to Look at How Well Semaglutide is at Lowering Weight When Taken Together With an Intensive Lifestyle Program
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Semaglutide; Placebo (semaglutide)
Intervention description: Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.; S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 611.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the change in participant's body weight from the start to the end of
      the study. This is to compare the effect on body weight in people taking semaglutide (a new
      medicine) and people taking "dummy" medicine. Together with the medicine, the participant
      will also be part of an intensive lifestyle program where the participant will have talks
      with study staff about healthy food choices, what the participant can do to lose weight and
      be more physically active. The participant will either get semaglutide or "dummy" medicine -
      which treatment the participant gets is decided by chance. The participant will need to take
      1 injection once a week. The study medicine is injected with a thin needle in a skin fold in
      the stomach, thigh or upper arm. For the first 2 months the participant will be on a low
      calorie diet. The diet is made up of bars, shakes and 1 low calorie pre-prepared meal for
      each day. The study will last for about 1.5 years. The participant will have 32 clinic visits
      with the study doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age more than or equal to 18 years at the time of signing informed
             consent

          -  Body mass index more than or equal to 30 kg/m^2 or more than or equal to 27 kg/m^2
             with the presence of at least one of the following weight-related comorbidities
             (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or
             cardiovascular disease

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Exclusion Criteria:

          -  Hemoglobin A1c more than or equal to 48 mmol/mol (6.5%) as measured by the central
             laboratory at screening

          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: tofacitinib; Placebo
Intervention description: 10 mg oral BID; Placebo oral BID
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 547.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Tofacitinib; CP-690; 550; Moderate to severe ulcerative colitis; phase 3 clinical trial; Mayo score

Summary:

      This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in
      patients with moderate to severe ulcerative colitis who have failed or be intolerant to one
      of following treatments for ulcerative colitis: oral steroids,
      azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be at least 18 years of age.

          -  Males and females with a documented diagnosis of UC at least 4 months prior to entry
             into the study.

          -  Subjects with moderately to severely active UC based on Mayo score criteria.

          -  Subjects must have failed or be intolerant of at least one of the following treatments
             for UC:

               -  Corticosteroids (oral or intravenous).

               -  Azathioprine or 6 mercaptopurine (6 MP).

               -  Anti TNF therapy.

        Exclusion Criteria:

          -  Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
             colitis, or clinical findings suggestive of Crohn's disease.

          -  Subjects with disease limited to distal 15 cm.

          -  Subjects without previous treatment for UC (ie, treatment naïve).

          -  Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab
Intervention description: 1000 mg intravenously on Days 1 and 15
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients
      with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or
      current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera
      1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24
      weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on
      study treatment is 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 18-80 years of age

          -  Moderate to severe active rheumatoid arthritis

          -  Inadequate response to a single previous or current treatment with an anti-TNF agent

          -  Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks

        Exclusion Criteria:

          -  Previous treatment with MabThera

          -  Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)

          -  Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than
             methotrexate

          -  Active infection, or history of serious or chronic infection
A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: ALKS 8700
Intervention description: Administered as specified in the treatment arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1057.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: MS; Relapsing Remitting Multiple Sclerosis; RRMS; dimethyl fumarate; DMF

Summary:

      The primary objective of this study is to evaluate the long-term safety and tolerability of
      ALKS 8700 for the treatment of Relapsing Remitting Multiple Sclerosis (RRMS). The secondary
      objective of this study is to evaluate treatment effect over time in adult participants with
      RRMS treated with ALKS 8700.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Has a confirmed diagnosis of RRMS

          -  Neurologically stable with no evidence of relapse within 30 days prior to Visit 2

        Exclusion Criteria:

          -  Subject is pregnant or breastfeeding or plans to become pregnant or begin
             breastfeeding at any point during the study and for 30 days after any study drug
             administration

          -  Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS

          -  History of clinically significant cardiovascular, pulmonary, gastrointestinal,
             dermatologic, psychiatric, neurologic (other than MS), and/or other major disease that
             would preclude participation in a clinical trial

          -  History of a myocardial infarction, including a silent myocardial infarction
             identified on ECG, or unstable angina

        NOTE: Other protocol defined Includison/Exclusion criteria may apply.
OTX-14-007: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis
Condition: Chronic Allergic Conjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Intervention: Dexamethasone; Placebo Vehicle
Intervention MeSH terms: Dexamethasone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone
      insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the
      treatment of the signs and symptoms of chronic allergic conjunctivitis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a positive history of ocular allergies and a positive skin test reaction to a
             perennial allergen and a seasonal allergen

          -  Has a positive bilateral CAC reaction to a perennial allergen within minutes of
             instillation

        Exclusion Criteria:

          -  History of refractive surgery (including LASIK procedures)

          -  History of retinal detachment, diabetic retinopathy, or active retinal disease

          -  Presence of an active ocular infection or positive history of an ocular herpetic
             infection at any visit

          -  Use any of the disallowed medications during the period indicated

          -  History of IOP increase as a result of steroid treatment
MK0431/ONO-5435 Phase III Clinical Trial -Add-on to Voglibose Study for Patients With Type 2 Diabetes Mellitus (MK0431-104)
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Comparator: Placebo; Sitagliptin; Voglibose
Intervention description: Placebo to sitagliptin once daily for 12 weeks (double-blind period); Sitagliptin/Sitagliptin arm only: Sitagliptin 50 mg once daily orally before breakfast for 12 weeks (double-blind period).
Both arms: Sitagliptin 50 mg once daily orally before breakfast for 40 weeks (open-label period). The dose of sitagliptin was increased up to 100 mg for participants who had an inadequate response to sitagliptin 50mg after treatment Week 20.; All participants received a stable dose of voglibose, in
accordance with the package insert, throughout the study.
Intervention MeSH terms: Sitagliptin Phosphate; Voglibose
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 133.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The phase III clinical trial examines the efficacy, safety, and tolerability of the addition
      of MK0431/ONO-5435 to Japanese patients with type 2 diabetes mellitus (T2DM) who have
      inadequate glycemic control on diet/exercise therapy and voglibose monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese Patients With Type 2 Diabetes Mellitus, Who Have Inadequate Glycemic Control
             On Diet/Exercise Therapy And Voglibose Monotherapy

        Exclusion Criteria:

          -  Patients Have A History Of Type 1 Diabetes Mellitus
MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; Comparator: sitagliptin phosphate (MK0431); Comparator: pioglitazone; Comparator: placebo (unspecified)
Intervention description: Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks; Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks; pioglitazone once daily for 52 weeks; Placebo once daily for 12 weeks
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The clinical study determines the safety and efficacy of MK0431 in patients with type 2
      diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients Have Type 2 Diabetes Mellitus

          -  On Diet/Exercise Therapy And Pioglitazone As Monotherapy

        Exclusion Criteria:

          -  Patients Have Type 1 Diabetes Mellitus