bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Placebo; GP2017 (adalimumab biosimilar); AIN457 150 mg
Intervention description: Matching placebo to AIN457 150 mg dose administered with AIN457 via pre-filled syringes; 40 mg in pre-filled syringes was administered subcutaneously; 150 mg in pre-filled syringes was administered subcutaneously
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study was partially blinded. Subjects, investigators, site personnel, persons performing the assessments, monitors and the Sponsor remained blinded to the dose group of secukinumab (150 mg versus 300 mg)
Masking: Single (Outcomes Assessor)
Masking description: The Participant, Care Provider, Investigator and Sponsor are blinded to Secukinumab dose
Enrollment: 859.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ankylosing spondylitis; AS; secukinumab; GP2017; adalimumab biosimilar; mSASSS; ASAS20; ASAS40; adult; r-axSpA; AIN457; radiographic; SURPASS

Summary:

      The purpose of this study is to demonstrate the impact of secukinumab on the progression of
      structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis
      Spine Score (mSASSS) in patients with Ankylosing Spondylitis (AS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-nursing female patients at least 18 years of age

          -  Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence
             (centrally read X-ray) fulfilling the Modified New York criteria for AS despite
             previous or current NSAID/ nonbiologic DMARD therapy

          -  Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10

          -  Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)

          -  Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)

          -  hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

        Exclusion Criteria:

          -  Patients with total ankylosis of the spine

          -  Pregnant or nursing (lactating) women

          -  Evidence of ongoing infectious or malignant process

          -  Previous exposure to any biologic immunomodulating agent, including those targeting
             IL-17, IL-17 receptor or TNFα

          -  Subjects taking high potency opioid analgesics

          -  Previous treatment with any cell-depleting therapies including but not limited to
             anti-CD20, investigational agents

        Other protocol-defined inclusion/exclusion criteria may apply
Individualized Obesity Pharmacotherapy
Condition: Obesity
MeSH terms: Obesity
Intervention: Phentermine-Topiramate; Liraglutide; Naltrexone/bupropion; Phentermine
Intervention description: Extended Release at dose of 7.5/46 mg oral daily; dose of 3 mg subcutaneous daily; Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening); 15-37.5 mg oral daily
Intervention MeSH terms: Liraglutide; Topiramate; Phentermine; Naltrexone; Bupropion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 193.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pharmacological; Obesity Management; Individualized

Summary:

      The researchers are trying to identify the specific characteristics (phenotypes) that may be
      useful to help select the right medication for weight loss.
    

Eligibility criteria:

        Inclusion criteria:

          -  Adults with obesity (BMI >30 Kg/m2); these will be otherwise healthy individuals with
             no unstable psychiatric disease and controlled comorbidities or other diseases.

          -  Gender: Men or women. Women of childbearing potential will have negative pregnancy
             tests within 48 hours of enrollment and before each radiation exposure.

        Exclusion criteria

          -  Abdominal bariatric surgery

          -  Positive history of chronic gastrointestinal diseases, or systemic disease that could
             affect gastrointestinal motility, or use of medications that may alter
             gastrointestinal motility, appetite or absorption, e.g., orlistat, within the last 6
             months.

          -  Significant untreated psychiatric dysfunction based upon screening with the Hospital
             Anxiety and Depression Inventory (HAD), and the Questionnaire on Eating and Weight
             Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by
             an anxiety or depression score >11 or difficulties with substance or eating disorders,
             the participant will be excluded and given a referral letter to his/her primary care
             doctor for further appraisal and follow-up.

          -  Hypersensitivity to any of the study medications.

          -  No contraindications to all FDA-approved medications
A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
Condition: Lung Diseases, Interstitial
MeSH terms: Lung Diseases; Lung Diseases, Interstitial
Intervention: Nintedanib
Intervention description: Bid
Intervention MeSH terms: Nintedanib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 435.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective is to assess long term tolerability and safety of treatment with oral
      nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have
      complete (and did not prematurely discontinue trial medication in) the phase III parent
      trial, INBUILD® (trial 1199.247).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients who completed the INBUILD® trial as planned and who did not
             prematurely discontinue blinded treatment.

          -  Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial.

          -  Women of childbearing potential (WOCBP)1 must continue to use highly effective methods
             of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per
             year when used consistently and correctly, as well as one barrier method, for 28 days
             prior to and 3 months after nintedanib administration. A list of contraception methods
             meeting these criteria is provided in the patient information

        Exclusion Criteria:

          -  Any disease that may put the patient at risk when participating in this trial.
             Reconsider carefully all exclusion criteria of the INBUILD® trial. However, patients
             may qualify for participation even though exclusion criteria may have been met during
             the course of participation in INBUILD®, if the investigator's benefit-risk assessment
             remains favourable.

          -  Patients who must or wish to continue the intake of restricted medications or any drug
             considered likely to interfere with the safe conduct of the trial

          -  Patient not compliant in parent trial (INBUILD®), with trial medication or trial
             visits, according to investigator's judgement.

          -  Previous enrolment in this trial. Further exclusion criteria apply.
MP0420 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: MP0420; Placebo; Remdesivir
Intervention description: MP0420 is a multi-valent DARPin® molecule (designed ankyrin repeat protein), consisting of 5 DARPin® domains.; Commercially available 0.9% sodium chloride solution; Antiviral agent
Intervention MeSH terms: Remdesivir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVID-19; COVID 19; Coronaviridae Infections; Coronavirus Infections; RNA Virus Infections; Virus Diseases; Nidovirales Infections; SARS-CoV-2; SARS Coronavirus; ACTIV-3; ACTIV3; TICO

Summary:

      This study looks at the safety and effectiveness of MP0420 in treating COVID-19 in people who
      have been hospitalized with the infection. Participants in the study will be treated with
      either MP0420 plus current standard of care (SOC), or with placebo plus current SOC. This is
      ACTIV-3/TICO Treatment Trial H5.
    

Eligibility criteria:

        Inclusion Criteria: Refer to the master protocol (NCT04501978)

        Exclusion Criteria: Refer to the master protocol (NCT04501978)

        Additional Exclusion Criteria:

          1. Pregnant women

          2. Nursing mothers

          3. Women of child-bearing potential who are unwilling to acknowledge the strong advice to
             abstain from sexual intercourse with men or practice appropriate contraception through
             11 weeks after receiving MP0420/placebo

          4. Men who are unwilling to acknowledge the strong advice to abstain from sexual
             intercourse with women of child-bearing potential or to use barrier contraception
             through 11 weeks after receiving MP0420/placebo.
A Study of Diazoxide Choline in Patients With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Intervention: DCCR; Placebo for DCCR
Intervention description: Once daily oral administration; Once daily oral administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: PWS; Prader-Willi Syndrome

Summary:

      The purpose of this is study is to evaluate the effects of DCCR (diazoxide choline controlled
      release tablets) in children and adults with Prader-Willi syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide voluntary, written informed consent (parent(s) / legal guardian(s) of
             patient); provide voluntary, written assent (patients, as appropriate)

          -  Genetically-confirmed Prader-Willi syndrome and hyperphagic

          -  In a stable care setting for at least 6 months prior to Visit 1

          -  Caregiver must have been caring for the patient for at least 6 months prior to Visit 1

        Exclusion Criteria:

          -  Have participated in an interventional clinical study (i.e., investigational drug or
             device, approved drugs or device evaluated for unapproved use) within prior 3 months

          -  Positive urine pregnancy test (in females of child-bearing potential) or females who
             are pregnant or breastfeeding, and/or plan to become pregnant or to breast-feed during
             or within 30 days after study participation

          -  Any other known disease and/or condition, which would prevent, in the opinion of the
             Investigator, the patient from completing all study visits and assessments required by
             the protocol
An Investigational Immuno-therapy Study of Nivolumab Combined With Ipilimumab Compared to Nivolumab by Itself After Complete Surgical Removal of Stage IIIb/c/d or Stage IV Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Intervention: nivolumab; ipilimumab
Intervention description: Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1844.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an investigational immunotherapy Nivolumab,
      when combined with Ipilimumab, is more effective than Nivolumab by itself, in delaying the
      return of cancer in patients who have had a complete surgical removal of stage IIIb/c/d or
      stage IV Melanoma
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Completely surgically resected stage IIIb/c/d or stage IV melanoma within 12 weeks of
             participation in study.

          -  Must have full activity or, if limited, must be able to walk and carry out activities
             such as light house work or office work

          -  No prior anti-cancer treatment for melanoma (except surgery for the melanoma lesion(s)
             and/or except for adjuvant radiation therapy (RT) after neurosurgical resection for
             central nervous system (CNS) lesions)

        Exclusion Criteria:

          -  History of uveal melanoma

          -  Patients with active, known or suspected autoimmune disease

          -  Prior treatment with interferon (if complete < 6 months prior to participation in
             study), anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any
             other antibody or drug specifically targeting T-cell co-stimulation or checkpoint
             pathways

        Other protocol defined inclusion/exclusion criteria could apply
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: AIN457; AIN457 Placebo
Intervention description: anti IL-17a monoclonal antibody; Placebo matching AIN457
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: axial spondyloarthritis; ankylosing spondylitis; non-radiographic axial spondyloarthritis; inflammatory back pain; spinal pain; secukinumab; AIN457

Summary:

      The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg
      compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease
      activity, fatigue, and predictability of disease flares in patients with axial
      spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal
      anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of
      secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess
      the potential additional benefits of dose escalation in patients with axSpA.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non
             radiographic axial spondylarthritis) according to ASAS axSpA classification criteria

          -  patients with back pain for at least 3 months and age of onset less than 45 years

          -  Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.

          -  Spinal pain numeric rating scale score of more than 4 at Baseline.

          -  inadequate response to or failure to respond to at least 2 different NSAIDs at the
             highest recommended dose for at least 4 weeks in total prior to randomization

        Key Exclusion Criteria:

          -  Chest X-ray or MRI with evidence of ongoing infectious or malignant process

          -  Patients previously treated with any biological immunomodulating agents, except those
             targeting tumor necrosis factor alpha.

          -  Patients who have been exposed to more than one anti-tumor necrosis factor alpha
             agent.

          -  Active ongoing inflammatory diseases other than axial spondyloarthritis

          -  Other ongoing mechanical diseases affecting the spine.
A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
Condition: Disease, Hodgkin
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: brentuximab vedotin; placebo
Intervention description: Every 21 days by IV infusion (1.8 mg/kg); Every 21 days by IV infusion
Intervention MeSH terms: Brentuximab Vedotin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 329.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Disease, Hodgkin; Drug Therapy; Hematologic Diseases; Immunotherapy; Lymphoma; Monomethylauristatin E

Summary:

      This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate
      the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC)
      compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following
      autologous stem cell transplant (ASCT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with HL who have received ASCT in the previous 30-45 days

          -  Patients at high risk of residual HL post ASCT

          -  Histologically-confirmed HL

          -  ECOG of 0 or 1

          -  Adequate organ function

        Exclusion Criteria:

          -  Previous treatment with brentuximab vedotin

          -  Previously received an allogeneic transplant

          -  Patients who were determined to have a best clinical response of progressive disease
             with salvage treatment immediately prior to ASCT

          -  History of another primary malignancy that has not been in remission for at least 3
             years

          -  Post ASCT or current therapy with other systemic anti-neoplastic or investigational
             agents
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: 217.0
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.
Rituximab to Prevent Recurrence of Proteinuria
Condition: FSGS; Proteinuria
MeSH terms: Proteinuria; Recurrence
Intervention: Rituximab
Intervention description: Induction therapy
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 7 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The investigators propose to study novel targets of rituximab in podocytes, with a particular
      focus on recurrent focal segmental glomerulosclerosis (FSGS). The proposed study has strong
      clinical implications, since it may extend the approved indications for rituximab treatment
      to recurrent FSGS as well as to other proteinuric diseases. Furthermore, it will offer new
      insights into the role of sphyngomyelin related enzymes in podocyte function in health and
      disease, thus allowing the identification of novel targets for antiproteinuric drug
      development. Finally, the proposed study offers the opportunity to identify a correlation
      between the patient's specific clinical outcome and the experimental results obtained after
      exposing podocytes to patient sera in the presence or absence of rituximab. Therefore, it may
      lead to the development of an assay for the pre-transplant identification of patients at
      high-risk for recurrent disease and, among them, may allow the identification of those
      patients that will respond to rituximab.
    

Eligibility criteria:

        Inclusion:

          1. Patient has been fully informed and has signed a dated IRB-approval informed consent
             form.

          2. Age 7-65 years.

          3. Male and Females diagnosed of FSGS by kidney biopsy. Kidney biopsy report is not
             required once the physician confirms the diagnosis. Transcribed reports from referring
             physicians are also valid.

        Exclusion:

          1. Recipient or donor is seropositive for human immunodeficiency virus (HIV), Hepatitis C
             viruses, or Hepatitis B virus antigenemia.

          2. Patient has a current malignancy or a history of malignancy (within the past 5 years),
             except non-metastatic basal or squamous cell carcinoma of the skin that has been
             treated successfully or carcinoma in situ of the cervix that has been treated
             successfully.

          3. Patient has uncontrolled concomitant infections and/or severe diarrhea, vomiting,
             active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any
             other unstable medical condition that could interfere with study objectives.

          4. Patient is pregnant or lactating.

          5. Patient has any form of substance abuse, psychiatric disorder or a condition that, in
             opinion of the investigator, may invalidate communication with the investigator.

          6. Patients with a defined genetic cause of FSGS.