bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safe and Effective Use of the Prefilled Safety Syringe or the Auto-injector for the Subcutaneous Self-injection of Bimekizumab Solution by Subjects With Moderate to Severe Chronic Plaque Psoriasis (PSO)
Condition: Chronic Plaque Psoriasis; Moderate to Severe Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Bimekizumab
Intervention description: Subjects will receive bimekizumab at pre-specified time-points.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 172.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bimekizumab; PSO; Psoriasis; Auto-Injector

Summary:

      The purpose of the study is to evaluate the ability of subjects with moderate to severe
      chronic plaque psoriasis (PSO) to safely and effectively self-inject bimekizumab at study
      start and 8 weeks after training in self-injection technique using a prefilled safety syringe
      or an auto-injector.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject fulfills all inclusion criteria for the PS0014 [NCT03598790] study

          -  Subject is considered reliable and capable of adhering to the DV0002 protocol (eg,
             able to understand and complete questionnaires, willing to self-inject, able to use
             investigational device according to the instructions for use (IFU), and able to adhere
             to the visit schedule) according to the judgment of the Investigator

        Exclusion Criteria:

          -  Subjects are not permitted to enroll in DV0002 if any of the PS0014 [NCT03598790]
             study exclusion criteria are met
Long-term Safety and Efficacy of Sirukumab in Participants With RA Completing Studies CNTO136ARA3002 or CNTO136ARA3003
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Sirukumab 100 mg; Sirukumab 50 mg; Placebo
Intervention description: Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.; Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.; Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1820.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Sirukumab; CNTO 136; CNTO136ARA3002; SIRROUND-D; CNTO136ARA3003; SIRROUND-T; SIRROUND-LTE

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of CNTO 136
      (sirukumab) in participants with rheumatoid arthritis (RA) who are unresponsive to treatment
      with modifying antirheumatic drugs (DMARDs) or anti-TNF alpha agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed participation in Studies CNTO136ARA3002 or CNTO136ARA3003

          -  Signed an informed consent form (ICF) indicating that they understand the purpose of
             and procedures required for the study and are willing to participate in the study

          -  Signed an informed consent form (ICF) for pharmacogenetics research (how a person's
             genes may affect a drug's effects) in order to participate in the optional
             pharmacogenetics component of this study. Refusal to give consent for this component
             does not exclude a participant from participation in this clinical study

        Exclusion Criteria:

          -  Withdraws consent and/or discontinues participation in study CNTO136ARA3002 or
             CNTO136ARA3003

          -  Is pregnant

          -  Has active diverticulitis

          -  Has any condition that, in the opinion of the investigator, would make participation
             not be in the best interest (eg, compromise the well-being) of the participant or that
             could prevent, limit, or confound the protocol-specified assessments
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma
Condition: Melanoma
MeSH terms: Melanoma; Recurrence
Intervention: Ipilimumab; Nivolumab; Placebo matching Ipilimumab; Placebo matching Nivolumab
Intervention description: Specified dose on specified days; Specified dose on specified days; 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 906.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether nivolumab is better than ipilimumab to
      prevent recurrence of melanoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 15 years of age Except: where local regulations and/or institutional policies
             do not allow for subjects < 18 years of age (pediatric population) to participate. For
             those sites, the eligible subject population is ≥ 18 years of age

          -  Completely removed melanoma by surgery performed within 12 weeks of randomization

          -  Stage IIIb/C or Stage IV before complete resection

          -  No previous anti-cancer treatment

        Exclusion Criteria:

          -  Ocular or uveal melanoma

          -  History of carcinomatosis meningitis

          -  History of auto-immune disease

          -  Treatment directed against the resected melanoma that is administrated after the
             surgery

        Other protocol-defined inclusion/exclusion criteria apply
Clearing the Fog: Is Hydroxychloroquine Effective in Reducing COVID-19 Progression
Condition: Covid19; Progression
MeSH terms: COVID-19; Disease Progression
Intervention: HCQ
Intervention description: Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization rules were designed by Dr. Wasim Alamgir together with principal investigators and implemented by an independent statistician who was not involved in data analysis. Stratified random sampling was applied to stratify all eligible patients according to age, gender and comorbidities. Computerized random number generator was used and allocation was done in 2:1 sequence. Cards with each group assignment number randomly generated by computer were placed in sequentially numbered envelopes that were opened as the patients were enrolled
Masking: None (Open Label)
Masking description: Neither patients, nor investigators, nor statisticians were masked to treatment assignment. Lab staff who performed sampling for PCR, basic blood tests and other routine measurement were unaware of treatment information.
Enrollment: 540.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COVID-19; viral clearance; , mild infection; disease progression; trial; HCQ

Summary:

      Brief Summary: Purpose of this study is to evaluate efficacy of hydroxychloroquine (HCQ) in
      reducing progression of Corona Virus Disease 2019 (COVID - 19) and achieving viral clearance.

      Condition or disease :I COVID-19 ntervention/treatment :Drug: Hydroxychloroquine Sulfate
      Phase: Phase III
    

Eligibility criteria:

        Inclusion Criteria:

          -  Mild Corona virus disease (COVID-19)

          -  PCR confirmed infection

          -  Hospital admitted patients

        Exclusion Criteria:

          -  Moderate, severe and critical COVID-19

          -  day 0 CRP greater than 6mg/dl, ALC < 1000 or evidence of infiltrates on X-ray chest

          -  comorbidity with life expectancy less than 6 months

          -  Contraindications to HCQ therapy
Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Condition: Biliary Tract Neoplasms
MeSH terms: Biliary Tract Neoplasms
Intervention: Durvalumab; Placebo
Intervention description: IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.; IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
Intervention MeSH terms: Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Durvalumab in Combination with Gemcitabine plus Cisplatin Placebo in Combination with Gemcitabine plus Cisplatin
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 810.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: First-Line Advanced Biliary Tract Cancers (BTC); Durvalumab; Gemcitabine/Cisplatin; Placebo

Summary:

      Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line
      Advanced Biliary Tract Cancer (TOPAZ-1)
    

Eligibility criteria:

        Inclusion

          1. Histologically confirmed, unresectable advanced or metastatic biliary tract, including
             cholangiocarcinoma (intrahepatic or extrahepatic) and gallbladder carcinoma.

          2. Patients with previously untreated disease if unresectable or metastatic at initial
             diagnosis will be eligible.

          3. Patient with recurrent disease >6 months after curative surgery or >6 months after the
             completion of adjuvant therapy (chemotherapy and/or radiation) will be eligible.

          4. WHO/ECOG PS of 0 or 1

        Exclusion

          1. History of another primary malignancy

          2. Brain metastases or spinal cord compression

          3. Uncontrolled intercurrent illness

          4. Major surgical procedure within 28 days prior to the first dose of IP.

          5. Prior locoregional therapy such as radioembolization
Randomized, Double-blind, Placebo Controlled, Multi-center and Tolerability of RBP-7000 in Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: RBP-7000; Placebo; Risperidone
Intervention description: RBP-7000 90 mg and 120 mg were a mixture of the ATRIGEL Delivery System and 90 mg and 120 mg risperidone, respectively. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. Subcutaneous RBP-7000 injections on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.; Subcutaneous injection of placebo using the ATRIGEL Delivery System on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.; Oral risperidone 0.25 mg tablets daily for the first two days of the screening period. The two 0.25 mg tablets confirmed whether study participants had any negative reaction to risperidone prior to receiving a long-acting injection of risperidone (RBP-7000).
Intervention MeSH terms: Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 354.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Schizophrenia; Schizophrenic; Schizophrenias; Risperidone

Summary:

      The purpose of this study is to evaluate the efficacy and safety of RBP-7000 compared with
      placebo in the treatment of patients with schizophrenia.

      This will be a double-blind, placebo-controlled, Phase III study with 90 mg and 120 mg doses
      of RBP-7000 compared with placebo over an 8-week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females between the ages of 18 to 55 years, inclusive

          -  Diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual, Edition 4,
             text revision (DSM-IV-TR) criteria

          -  Subjects who are deemed "valid" by the State, Assessability, Face, Ecological, and
             Rule (SAFER) interview

          -  Subjects who are otherwise healthy on the basis of their physical examination

        Exclusion Criteria:

          -  Subjects who have an improvement in their total Positive and Negative Syndrome Scale
             (PANSS) score of 20% or greater between the initial screening visit and the first day
             of treatment.

          -  Subjects taking daily oral risperidone at a dose ≥ 6 mg/day

          -  Subjects who have received a depot antipsychotic within 120 days of screen

          -  Subjects with treatment resistant schizophrenia, as judged by the investigator, who
             have been treated with antipsychotics for adequate durations and with adequate
             dosages.
Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: suprachoroidal CLS-TA; suprachoroidal sham; IVT aflibercept
Intervention description: suprachoroidal injection of CLS-TA; suprachoroidal sham procedure; 2 mg intravitreal injection of aflibercept
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Aflibercept; Triamcinolone diacetate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 460.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: RVO; ME; Central Subfield Thickness; OCT; Optical Coherence Tomography; Cystoid Macular Edema; Subretinal Fluid; Eylea; Aflibercept; Anti-VEGF; Suprachoroidal; Triamcinolone acetonide

Summary:

      This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12
      months duration in treatment naïve subjects with RVO.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a clinical diagnosis of RVO in the study eye

          -  Has a CST of ≥ 300 µm in the study eye

          -  Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;

          -  Is naïve to local pharmacologic treatment for RVO in the study eye;

        Exclusion Criteria:

          -  Any active ocular disease or infection in the study eye other than RVO

          -  History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring
             more than one medication

          -  Any uncontrolled systemic disease that, in the opinion of the Investigator, would
             preclude participation in the study

          -  Any evidence of neovascularization in the study eye
Treatment of Moderate to Severe Lateral Canthal Lines
Condition: Lateral Canthal Lines
Intervention: botulinum toxin; Placebo
Intervention description: neuromodulator; placebo
Intervention MeSH terms: Botulinum Toxins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to evaluate the efficacy and safety of a single dose of
      QM1114-DP compared to placebo for the treatment of moderate to severe LCL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years of age or older.

          2. Moderate to severe LCL at maximum smile as assessed by the Investigator.

          3. Moderate to severe LCL at maximum smile as assessed by the subject.

        Exclusion Criteria:

          1. Previous use of any Botulinum toxin treatment in facial areas within 9 months prior to
             study treatment.

          2. Female who is pregnant, breast feeding, or intends to conceive a child during the
             study.

          3. Known allergy or hypersensitivity to any component of the investigational product
             (QM1114-DP) or any botulinum toxin serotype.
A Study of Oral Contraception Under Simulated OTC Conditions
Condition: Contraception
Intervention: Norgestrel 0.075 mg tablets
Intervention description: All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.
Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet.
Intervention MeSH terms: Norgestrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: Female
Minimum age: 12 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Daily birth control

Summary:

      This study is designed to assess whether consumers select and use norgestrel 0.075 mg, a
      progestin only pill for contraception, in a manner consistent with the OTC package directions
      in an Over-the-Counter (OTC)-like setting.
    

Eligibility criteria:

        Inclusion Criteria:

        -Women who are willing purchase (in the pharmacies) or be provided (in the clinics) oral
        contraception for their own use for the purposes of the study

        Exclusion Criteria:

          -  Cannot read, speak and understand English

          -  Cannot see well enough to read information on the label
Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Condition: Acute Heart Failure (AHF)
MeSH terms: Heart Failure
Intervention: Serelaxin; Standard of Care
Intervention description: 30 µg/kg/day IV infusion; This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2666.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AHF,; RLX030,; SOC,; WHF,; RELAX-AHF-EU; Renal Impairment

Summary:

      This was a multinational, multicenter, randomized, open-label study to confirm and expand the
      efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30
      micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for
      Acute Heart Failure (AHF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Systolic blood pressure ≥ 125 mmHg

          -  Admitted for Acute Heart Failure (AHF)

          -  Received intravenous furosemide (or equivalent) at any time between presentation and
             the start of screening

          -  eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m^2

        Exclusion Criteria:

          -  Dyspnea (non-cardiac causes)

          -  T > 38.5°C

          -  Clinical evidence of acute coronary syndrome currently or within 30 days prior to
             enrollment.

          -  Significant left ventricular outflow obstruction, uncorrected, such as obstructive
             hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0
             cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic
             regurgitation and severe mitral stenosis.

          -  AHF due to significant arrhythmias

          -  Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive
             cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler
             echocardiographic assessments of diastolic function).
Open-Label Extension Study Of Rosiglitazone XR As Adjunctive Therapy In Subjects With Mild-to-Moderate Alzheimers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Rosiglitazone XR
Intervention description: Experimental drug
Intervention MeSH terms: Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1461.0
Sex: All
Minimum age: 51 Years
Maximum age: 91 Years
Healthy volunteers: No
Keywords: cognition; Alzheimer's disease; Rosiglitazone extended-release (XR); safety; adjunctive therapy; BRL-049653; tolerability; open-label extension

Summary:

      This is a Phase III, multicenter, open-label extension, single-group study in male and female
      outpatients with mild-to-moderate Alzheimer's disease (AD) who have completed either
      AVA102670 or AVA102672. All subjects will receive rosiglitazone extended-release (RSG XR) 4mg
      once daily for the first 4 weeks of the study followed by 8mg RSG XR as adjunctive therapy to
      their existing dose of acetylcholinesterase inhibitor. Subject participation will last until
      one of 5 conditions applies. After a 52-week open-label treatment phase, subjects will attend
      a final Follow-Up Visit 6 weeks after the end of treatment. The primary objective of this
      study is to evaluate the long-term safety and tolerability of RSG XR in subjects with
      mild-to-moderate AD who have completed either AVA102670 or AVA102672. The secondary objective
      of this study is to explore further the long-term efficacy of RSG XR in terms of cognitive
      function and overall clinical response as a function of apolipoprotein E (APOE) e4 allele
      status.
    

Eligibility criteria:

        Inclusion criteria:

          -  Successful completion of AVA102670 or AVA102672 without safety or tolerability issues.
             Regular caregiver.

        Exclusion criteria:

          -  Congestive Heart Failure (NYHA 1-4), clinically significant peripheral edema, other
             neurological conditions that might disqualify participation. SAE, clinically
             significant laboratory abnormality or significant cardiovascular event during prior
             study.