bioihbjkbjnl/mcl2 huggingface dataset:
Study of Rapastinel as Monotherapy in Patients With MDD
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel (prefilled syringe, weekly intravenous IV administration); Placebo (prefilled syringe, weekly IV administration)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 439.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900
      milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive
      disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
             criteria for MDD

          -  Current major depressive episode of at least 8 weeks and not exceeding 18 months in
             duration at Visit 1

          -  Treatment naive in the current episode or have inadequate response to 1-3
             antidepressant therapies given at adequate dose and duration in the current episode

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test

        Exclusion Criteria:

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

          -  Schizophrenia spectrum or other psychotic disorder

          -  Bipolar or related disorder

          -  Major neurocognitive disorder

          -  Neurodevelopmental disorder of greater than mild severity or of a severity that
             impacts the participant's ability to consent, follow study directions, or otherwise
             safely participate in the study

          -  Dissociative disorder

          -  Posttraumatic stress disorder

          -  MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator
Borage and Echium Seed Oils for Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Borage and Echium Seed Oils; Corn oil pills
Intervention description: 4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks.; Corn oils pills will be taken three times per day for six weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma; Borage; Echium; Botanical

Summary:

      This study plans to look at whether borage and echium seed oils (natural oils from two
      plants) help decrease asthma symptoms and affect cells involved in inflammation. The
      investigators also want to look at how these plant oils decrease the generation of
      inflammatory cells in people with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female 18 years to 65 years of age

          2. Stable physician diagnosed asthma with FEV1 of greater than 50% of predicted but less
             than 90% of predicted or less than 90% of known best and an asthma control
             questionnaire(ACQ) < 1.5.

        Exclusion Criteria:

          1. Pregnant or nursing

          2. Smoking history of > 10 pack years or active smoking within the past year.

          3. Due to possible effects on LT biosynthesis, use of the following asthma treatments
             within the preceding month will be exclusion criteria:

               -  LT modifying drugs (zileuton, montelukast, zafirlukast)

               -  theophylline

               -  oral steroids

               -  dietary supplements with fatty acids or other products that may interfere with LT
                  generation.

          4. Treatment within the previous three months with omalizumab (monoclonal antibody
             directed against IgE)

          5. Subjects will not be permitted to take non-steroidal anti-inflammatory drugs in the
             week prior to any measurements of ex vivo LT generation because of their effects on LT
             biosynthesis via inhibition of prostaglandin generation.

          6. A history of aspirin-sensitive asthma will be an exclusion criterion as the effects of
             GLA/SDA on prostanoid biosynthesis have not been adequately elucidated.

          7. Significant abnormalities in CBC, differential white cell count, renal function, and
             liver function, or urinalysis.

          8. No subjects will have any serious co-morbid medical condition.
P3 Study in Acne Comparing Once Daily SB204 and Vehicle
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 4%; Vehicle Gel
Intervention description: Once daily; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1307.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a 12 week, multi-center, double-blinded, randomized, vehicle-controlled, parallel
      group, study to be conducted in approximately 1300 subjects with acne vulgaris in the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe acne

          -  Minimum of 25 and no more than 70 non-inflammatory lesions (open and closed comedones)
             on the face

          -  Minimum of 20 and no more than 40 inflammatory lesions (papules and pustules)

        Exclusion Criteria:

          -  Women of child-bearing potential who are pregnant, nursing, considering becoming
             pregnant

          -  Any dermatologic condition that could interfere with clinical evaluations including
             severe, recalcitrant cystic acne
StrataGraft® Skin Tissue Expanded Access at Specific Study Sites ( StrataCAT )
Condition: Deep Partial-thickness Burn
Intervention: StrataGraft skin tissue
Intervention description: StrataGraft skin tissue was delivered as a single topical application to no more than 3 separate burn sites, totaling up to approximately 2000 cm^2 of treatment area using no more than 20 tissues.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Alternative to Autograft

Summary:

      An autograft is a piece of skin taken from a healthy area of the body to be used to treat
      severe burns on another part of the same body.

      StrataGraft skin tissue was an investigational tissue that could be used as an alternative to
      an autograft.

        -  StrataGraft skin tissue was in late-stage clinical development for the treatment of
           adults with deep partial-thickness (DPT) burns.

        -  There were no safety concerns reported to date. The sponsor submitted a treatment
           protocol to Food and Drug Administration (FDA) for doctors who participated in the Phase
           3 Strata 2016 study (NCT 03005106) to allow for expanded access to StrataGraft before it
           was commercially available.

      The main purpose of the study was to allow patients to receive StrataGraft during Biologics
      License Application review and prior to approval by the FDA for the treatment of DPT burns.
      The primary outcome measure was the number of participants with adverse events and safety
      concerns.
    

Eligibility criteria:

        Inclusion Criteria:

        To be considered for inclusion, a participant must:

          -  Provide written informed consent

          -  Have enough healthy skin to reserve as donor site(s), in case autografting becomes
             necessary

          -  Have protocol-defined thermal burn(s) on the torso, upper extremities and lower
             extremities:

               1. that are the right size for treatment areas,

               2. with intact dermal elements for which excision and autografting are clinically
                  indicated, and

               3. have not been previously excised and grafted.

        Exclusion Criteria:

        A participant must be excluded from participation if he/she:

          -  Is pregnant, a prisoner, or expected to live less than 3 months

          -  Has any other condition that, per protocol or in the opinion of the investigator, may
             compromise the participant's safety or the study objectives

          -  Has participated in an investigational study within 90 days before enrollment
Study of Apixaban for the Prevention of Thrombosis-related Events Following Knee Replacement Surgery
Condition: Deep Vein Thrombosis; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Venous Thrombosis
Intervention: Enoxaparin + Placebo; Apixaban + Placebo
Intervention description: Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period; Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period
Intervention MeSH terms: Enoxaparin; Apixaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 3608.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery

Summary:

      The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep
      vein Thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur after knee
      replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for
      preventing these clots. The safety of apixaban will also be studied.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Men and non-pregnant, non-breastfeeding women

          -  18 years or older

          -  Scheduled for knee replacement surgery

        Key Exclusion Criteria:

          -  hereditary or acquired bleeding disorders

          -  clotting disorders

          -  bleeding or high risk for bleeding

          -  drugs that affect bleeding or coagulation

          -  need for ongoing parenteral or oral anticoagulation
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients
Condition: Anemia
MeSH terms: Uterine Hemorrhage; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Carboxymaltose; Standard Medical Care (SMC)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2018.0
Sex: Female
Healthy volunteers: No

Summary:

      The Objective of this study is to study the safety of FCM in patients with anemia caused by
      Heavy Uterine Bleeding and the Post Partum state.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female with iron deficiency anemia

          -  Hg </= 11 g/dL

        Exclusion Criteria:

          -  Previous participation in a FCM trial

          -  Known Hypersensitivity to FCM

          -  History of anemia other that anemia due to heavy uterine bleeding or the post partum
             state

          -  current history of GI bleeding

          -  Received IV Iron within the month prior

          -  Anticipated need for surgery

          -  Malignancy history

          -  AST or ALT greater than normal

          -  Received an investigational drug within 30 days of screening

          -  Pregnant or sexually active females who are not willing ot use an effective form of
             birth control
A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants
Condition: Meningitis, Meningococcal
MeSH terms: Meningitis, Meningococcal; Meningitis
Intervention: Meningococcal ACWY Conjugate Vaccine; DTaP-IPV-HBV; Hib; Rotavirus; Pneumococcal 7-valent Conjugate Vaccine; HAV; MMR-V; DTaP
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4545.0
Sex: All
Minimum age: 2 Months
Maximum age: 2 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Meningococcal; meningitis; vaccine; infants; Meningococcal meningitis; Meningococcal disease

Summary:

      This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY
      conjugate vaccine when administered with routine infant vaccinations to healthy infants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy term 2-month-old infants for whom a parent/legal representative has given
             written informed consent.

        Exclusion Criteria:

          -  Subjects with a previous or suspected disease caused by Neisseria meningitidis,
             Corynebacterium diphtheriae, Clostridium tetani, Poliovirus, Hepatitis B, Haemophilus
             influenzae type b (Hib), Pneumococcus or Bordetella pertussis; previous immunization
             with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior
             vaccination with Diptheria, Tetanus, Pertussis (acellular or whole cell), inactivated
             polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus;
             who have had household contact with and/or intimate exposure to an individual with
             laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis,
             Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any
             serious acute, chronic or progressive disease
Open Label Study of Adalimumab in Subjects Who Have a Sub-optimal Response to Systemic Therapy or Phototherapy
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: adalimumab
Intervention description: Participants received an 80 mg adalimumab loading dose by subcutaneous injection at Baseline (Week 0). From Week 1 to Week 15, participants received 40 mg adalimumab by subcutaneous injection every other week.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study was to evaluate the safety and efficacy profile of Humira
      (adalimumab) in patients who had a sub-optimal response to prior systemic therapy. This
      open-label study was conducted in a patient population of moderate to severe chronic plaque
      psoriasis patients, which is an approved patient population for adalimumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic plaque psoriasis with disease duration of at least 6 months

          -  Sub-optimal response to treatment with etanercept, methotrexate, or narrow-band UVB
             phototherapy

        Exclusion Criteria:

          -  Prior treatment with adalimumab

          -  Multiple concomitant therapy restrictions and/or washouts (topicals, ultraviolet,
             other systemic psoriasis therapies)

          -  Prior treatment with natalizumab

          -  Concurrent active skin diseases/infections

          -  Poorly controlled medical conditions

          -  History of neurologic symptoms suggestive of central nervous system (CNS)
             demyelinating disease

          -  History of certain cancers
Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia
Condition: Post Caesarean Analgesia
MeSH terms: Agnosia
Intervention: ropivacaine infiltration; intrathecal morphine; placebo
Intervention description: wound infiltration; 100 µg added to the spinal anaesthesia; placebo in spinal anaesthesia and in wound infiltration
Intervention MeSH terms: Morphine; Ropivacaine; Anesthetics, Local; Anesthetics
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 192.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: analgesia; caesarean; wound infiltration; intrathecal morphine.

Summary:

      The aim of this study is to compare effective analgesia with continuous wound infiltration of
      ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to
      spinal anesthesia, after elective Caesarean delivery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of
             gestational age, admitted for a planned caesarian with a Pfannenstiel incision and
             having signed the informed consent form.

        Exclusion Criteria:

          -  Refusal of the patient or contra-indication to locoregional anesthesia

          -  Allergy to the products used

          -  ASA 3

          -  ASA 4

          -  Sleep apnea syndrome and/or obesity (BMI > 35)

          -  Size inferior to 155cm

          -  existence of a language barrier
PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: Apremilast 20mg; Apremilast 30mg; Placebo + 20 mg Apremilast; Placebo + 30 mg Apremilast
Intervention description: Apremilast 20 mg twice daily, orally; Apremilast 30 mg twice daily, orally; Placebo + 20 mg Apremilast; Placebo + 30 mg Apremilast
Intervention MeSH terms: Thalidomide; Apremilast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 488.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriasis; Arthritis; Psoriatic Arthritis; inflammation; skin condition; inflammatory cells; apremilast; CC-10004; phosphodiesterase type 4

Summary:

      The purpose of this study is to determine whether apremilast is safe and effective in the
      treatment of patients with psoriatic arthritis.

      Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and
      swollen joints, pain, physical function) in treated patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females, aged ≥ 18 years at time of consent.

          -  Have a diagnosis of Psoriatic Arthritis (PsA, by any criteria) of ≥ 6 months duration.

          -  Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) PsA at time of
             screening.

          -  Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)

          -  May not have axial involvement alone

          -  Concurrent Treatment allowed with methotrexate, leflunomide, or sulfasalazine

          -  Have ≥ 3 swollen AND ≥ 3 tender joints.

          -  Males & Females must use contraception

          -  Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose
             oral corticosteroids allowed.

        Exclusion Criteria:

          -  Pregnant or breast feeding.

          -  History of allergy to any component of the investigational product.

          -  Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.

          -  Therapeutic failure on > 3 agents for PsA or > 1 biologic tumor necrosis factor (TNF)
             blocker
A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; Placebo
Intervention description: 8mg/kg iv every 4 weeks for 24 weeks; iv every 4 weeks for 24 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 209.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and
      symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with
      active rheumatoid arthritis who currently have an inadequate response to DMARD therapy.
      Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks,
      in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12
      months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-70 years of age;

          -  rheumatoid arthritis for >= 6 months;

          -  receiving permitted DMARDs, at a stable dose, for >= 8 weeks prior to baseline;

          -  current inadequate clinical response to DMARDs.

        Exclusion Criteria:

          -  major surgery, including joint surgery, within 8 weeks before entering study, or
             planned major surgery within 6 months following randomization;

          -  rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid
             arthritis;

          -  unsuccessful treatment with an anti-TNF agent;

          -  previous treatment with tocilizumab.
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
Condition: Primary Hypercholesterolemia; Mixed Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Comparator: simvastatin; niacin (+) laropiprant; Comparator: atorvastatin calcium
Intervention description: simvastatin (20mg to 40mg) for 12 weeks.; One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.; atorvastatin calcium (20mg to 40mg) for 12 weeks.
Intervention MeSH terms: Niacin; Atorvastatin; Simvastatin; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1216.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed
      dyslipidemia to study the effects of ER niacin/laropiprant on lipids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia

          -  Patients will be eligible for the study if their LDL-C values are within protocol
             specified range and meet other entry criteria

        Exclusion Criteria:

          -  Patient whose LDL-C values are not within protocol specified range