bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Treatment-Resistant
Intervention: Risperidone; Olanzapine; Lu AF35700; Lu AF35700
Intervention description: 4-6 mg/day, encapsulated tablets, orally; 15-20 mg/day, encapsulated tablets, orally; 10 mg/day, encapsulated tablets, orally; 20 mg/day, encapsulated tablets, orally
Intervention MeSH terms: Olanzapine; Risperidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1098.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in
      patients with treatment-resistant schizophrenia (TRS)
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and
             Statistical Manual of Mental Disorders) and confirmed by the Mini International
             Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders

          -  The patient is either an inpatient at a psychiatric setting or outpatient consulting a
             psychiatrist.

          -  Patients should be treated with adequate dose(s) and agent(s) of antipsychotic
             treatment for at least 2 weeks prior to Screening

          -  The patient has failed to show an adequate response in the level of psychotic symptoms
             despite at least one documented treatment trial with an adequate dose of an
             antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks)
             during 2 years prior to Screening. The failure to respond to the current antipsychotic
             treatment trial may be considered a retrospective failed treatment, if the patient was
             treated for 6 weeks with adequate dose(s) and agent(s)

          -  The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the
             following PANSS items (at Screening and at the first visit of Period A)

          -  The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

        Exclusion Criteria:

          -  The patient has any current primary psychiatric disorder other than schizophrenia as
             assessed by the Mini International Neuropsychiatric Interview (MINI)

          -  The patient is experiencing an acute exacerbation of his/her psychotic symptoms

          -  The patient has not responded to treatment with clozapine

        Other protocol defined inclusion and exclusion criteria may apply
Long Term Safety Study of Plecanatide
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Intervention: Plecanatide
Intervention MeSH terms: Plecanatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2272.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      Multi-center, open-label, long-term safety study
    

Eligibility criteria:

        Inclusion Criteria:

        Patients with documented diagnosis of IBS-C who:

          -  Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the
             previous study's requirements, and did not experience any Serious Adverse Event (SAE)
             deemed related to study drug during the course of the previous study, OR

          -  Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an
             exclusion in the core study) or due to an administrative reason and is allowed to
             enter this study by notification from Sponsor or delegate.

        Key Exclusion Criteria:

          -  Patient is unwilling or unable to: participate in the study for the required duration,
             understand and sign the informed consent form (ICF) and undergo all protocol related
             tests and procedures throughout the study.

          -  Female patient of childbearing potential with a positive urine pregnancy test on Day
             1.

          -  Male and female patients of childbearing potential who do not agree to continue to use
             the method of birth control used in the core double-blind plecanatide study for the
             duration of this clinical trial.

          -  Patient has experienced a significant negative change in health status during the
             course of participation in the core double-blind plecanatide study or after completion
             of the study.

          -  In the opinion of the Investigator or Medical Monitor, it is not in the patient's best
             interest to participate in the study. The reason(s) for the patient's exclusion must
             be specified.
Lidocaine Patches After Cesarean Section
Condition: Postoperative Pain; Obstetric Pain; Opioid Use
MeSH terms: Labor Pain
Intervention: Lidocaine patch
Intervention description: Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be a prospective randomized non-blinded controlled trial. All cesarean sections for women undergoing their first or second cesarean delivery will be included. Patients will be approached and consented during the pre-operative period when presenting for scheduled surgery or at the time of consent for a non-scheduled cesarean section. The lidocaine patch would be placed on the superior-lateral aspect of the Pfannenstiel incision in the PACU prior to being transferred to the postpartum floor.
Masking: Single (Outcomes Assessor)
Masking description: Outcomes assessor/statistician will not be made aware of the treatment group of the patients.
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Maximum age: 52 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The aim of this study is to investigate the impact of using lidocaine patches after cesarean
      section on pain control and opioid use in the immediate post-operative period. The hypothesis
      is the use of lidocaine patches in the immediate post-operative period will lead to a
      decrease in the use of opioids as pain control compared to patients that do not have a
      lidocaine patch in place. Additionally, the a decrease in the visual analog pain score
      compared to women who do not use a lidocaine patch in the immediate post-operative period
      following cesarean delivery is anticipated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Primary or secondary cesarean delivery

          -  Able to consent to research study

        Exclusion Criteria:

          -  3 or more prior cesarean deliveries

          -  History of abdominoplasty

          -  History of abdominal hernia repair with mesh

          -  Allergy to lidocaine

          -  Allergy to adhesives in medical tape

          -  Women who received general anesthesia for their cesarean delivery

          -  Women with active substance abuse

          -  Women methadone or suboxone for a history of opiate abuse
Study Evaluating Bazedoxifene Acetate In Osteoporosis In Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Bazedoxifene Acetate; Placebo
Intervention description: BZA 20mg, daily, oral; Placebo, daily, oral
Intervention MeSH terms: Bazedoxifene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Enrollment: 7609.0
Sex: Female
Minimum age: 55 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoporosis; Postmenopause

Summary:

      The purpose of this study is to determine whether bazedoxifene acetate is safe and effective
      in the treatment of osteoporosis in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 2 years postmenopausal

          -  Osteoporotic subjects without vertebral fracture who meet BMD criteria, or
             Osteoporotic subjects with vertebral fracture

        Exclusion Criteria:

          -  Diseases that may affect bone metabolism

          -  Vasomotor symptoms requiring treatment

          -  Known history or suspected cancer of the breast

          -  Active or past history of venous thromboembolic events
Safety and Efficacy Study of Bimatoprost in Japanese Patients With Chemotherapy-Induced Eyelash Hypotrichosis
Condition: Eyelash Hypotrichosis
MeSH terms: Hypotrichosis
Intervention: bimatoprost solution 0.03%; bimatoprost vehicle solution
Intervention description: One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.; One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of bimatoprost solution 0.03% compared with
      vehicle in Japanese adults with hypotrichosis of the eyelashes following chemotherapy
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have inadequate eyelashes due to chemotherapy treatment

          -  Treated for solid tumors such as breast or colorectal cancer in early stages where the
             cancer has not spread outside the primary organ (eg, stage 1, 2 or 3a for breast
             cancer)

          -  Have completed chemotherapy treatment for at least 4 weeks but not more than 24 weeks
             and all side effects related to chemotherapy are recovered, improved or maintained,
             with the exception of hair loss

        Exclusion Criteria:

          -  Any disease/infection/abnormality of the eye or area around the eye

          -  Any ocular surgery within 3 months or anticipated need for ocular surgery during the
             study

          -  Any permanent eyeliner or implants of any kind or anticipated use of false eyelashes

          -  Any semi-permanent eyelash tint, dye, curl or eyelash extension application within 3
             months

          -  Use of any over-the-counter eyelash growth product within 6 months or any use of
             prescription eyelash growth products

          -  Use of treatments which may affect hair growth (eg, minoxidil) within 6 months except
             for prior chemotherapy
Antenatal Micronutrient Supplementation and Infant Survival
Condition: Infant Mortality; Preterm Birth; Low Birth Weight; Neonatal Mortality; Perinatal Mortality
MeSH terms: Premature Birth; Perinatal Death; Birth Weight; Infant Death
Intervention: Iron (27 mg) - folic acid (600 ug); Multiple micronutrient
Intervention description: Supplement serves as the "Control" (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.; Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).
Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum.
Intervention MeSH terms: Iron; Trace Elements; Folic Acid; Micronutrients
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44567.0
Sex: Female
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: micronutrients; deficiency; pregnancy; birth outcomes; infant mortality; neonatal mortality; malnutrition; antenatal

Summary:

      The purpose of this community-based randomized trial is to examine whether a daily antenatal
      and postnatal multiple micronutrient supplement given to women will enhance newborn and
      infant survival and health and other birth outcomes in a rural setting in northwestern
      Bangladesh.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pregnant and consents to participate

        Exclusion Criteria:

          -  Not interviewed for consent within 12 consecutive weeks after being ascertained as
             pregnant by urine testing
Study of Efficacy and Safety of Omalizumab in Refractory Chronic Spontaneous Urticaria Patients
Condition: Chronic Spontaneous Uriticaria
MeSH terms: Urticaria; Chronic Urticaria
Intervention: Omalizumab; Placebo
Intervention description: Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.; Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
Intervention MeSH terms: Omalizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 218.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic spontaneous uriticaria; Omalizumab

Summary:

      This was a Phase III, multicenter, randomized, double-blind, placebo-controlled,
      parallel-group study to evaluate the efficacy and safety of omalizumab administered
      subcutaneously as an add-on therapy for the treatment of adolescent and adult participants 12
      - 75 years who received the diagnosis of refractory chronic spontaneous uriticaria and who
      remained symptomatic despite standard-dosed non-sedating H1 antihistamine treatment.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of chronic spontaneous urticaria refractory to H1 antihistamine at the time
             of randomization

          -  Chronic spontaneous urticaria diagnosis for 6 months

        Key Exclusion Criteria:

          -  Weight less than 20 kg

          -  Clearly defined underlying etiology for chronic urticaria other than chronic
             spontaneous urticaria

          -  Evidence of parasitic infection

          -  Any other skin diseases than chronic spontaneous urticaria with chronic itching

          -  Previous treatment with omalizumab

          -  Contraindications to diphenhydramine

          -  History of anaphylactic shock

          -  History or current diagnosis of ECG abnormalities indicating significant risk of
             safety for patients participating in the study

          -  History of hypersensitivity to omalizumab or to drugs of similar chemical classes

          -  Pregnant or nursing (lactating) women
Metabolic Cost Savings for Transtibial Amputees Wearing the Controlled Energy Storage and Return (CESR) Foot
Condition: Transtibial Amputation
Intervention: CESR Prosthetic Foot; typical prosthetic foot; standardized prosthetic foot
Intervention description: a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle; patients will wear the prosthetic foot that they were prescribed by the care providers in the clinical team; a standard foot that has had weights applied to match the mass of the CESR foot
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amputee; Economy; Efficiency; Foot; Gait; Kinematics; Kinetics; Prosthesis

Summary:

      To determine if below-knee amputees will walk with better efficiency wearing a CESR foot
      which stores energy at heel strike and releases energy releases energy during push-off.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Transtibial Amputees > 1 year walking with prosthesis

          -  Non-amputee control subjects

        Exclusion Criteria:

          -  Additional musculoskeletal pathology

          -  Cognitive limitation
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: BIIB017 (peginterferon beta-1a); Placebo
Intervention description: Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.; Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1516.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: interferon; injectable; MS; SC; PEGylated; Interferon beta-1a; relapsing; PEG; multiple sclerosis; subcutaneous

Summary:

      The primary objective of this study is to determine the efficacy of peginterferon beta-1a in
      reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis
      (RMS) at 1 year. The secondary objectives of this study are to determine whether
      peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the
      total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance
      imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the
      progression of disability.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by
             McDonald criteria 1 through 4 (Polman, 2005)

          -  Must have an EDSS score between 0.0 and 5.0.

          -  Must have experienced at least 2 relapses that have been medically documented within
             the last 3 years with at least one occurring in the last 12 months

        Key Exclusion Criteria:

          -  Other chronic disease of immune system, malignancies, urologic, pulmonary,
             gastrointestinal disease

          -  Pregnant or nursing women

          -  Prior treatment with interferon could not exceed 4 weeks and subjects must have
             discontinued interferon treatment 6 months prior to Baseline

        NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Tele-Electrocardiography in Emergency Cardiac Care
Condition: Myocardial Infarction; Chest Pain
MeSH terms: Myocardial Infarction; Infarction; Emergencies; Chest Pain
Intervention: Electrocardiogram (ECG) Intervention; Routine Clinical Practice
Intervention description: Pre-hospital electrocardiographic (ECG) monitoring with special software to detect myocardial ischemia and to automatically transmit an ECG to the destination hospital emergency department with a voice alarm announcing "Incoming ECG from the field" and print out in the ED.; ECG in the ED as part of routine clinical practice.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 794.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Telemedicine; Emergency Care; Cardiac

Summary:

      The purpose of this study is to see whether individuals who access the "911" emergency
      medical system with a heart attack or severe chest pain will receive more timely hospital
      treatment and better outcomes if hospital clinicians are provided with earlier and more
      complete electrocardiography (ECG) information.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All individuals in Santa Cruz County in California who call 911 with symptoms of acute
             coronary syndrome (chest pain, shortness of breath, anginal equivalent).

        Exclusion Criteria:

          -  Those who don't meet the above inclusion criteria.
Study of the Safety of Brolucizumab 6 mg in Prefilled Syringe in Patients With Neovascular Age Related Macular Degeneration
Condition: Neovascular Age Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: RTH258
Intervention description: 6 mg in prefilled syringe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: study with a single arm: brolucizumab 6 mg PFS
Masking: None (Open Label)
Masking description: open label study
Enrollment: 34.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: brolucizumab 6 mg prefilled syringe PFS; open label study; neovascular age related macular degeneration intravitreal injection IVT; observation

Summary:

      This was a multicenter, open label study that is designed to evaluate the safety of
      brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular
      degeneration and to support collection of observations of the prefilled syringe use for
      intravitreal injection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent must be obtained before any assessment is performed.

          2. Study eye is diagnosed with neovascular age related macular degeneration and would
             need an intravitreal injection.

          3. Subjects >= 50 years of age.

        Exclusion Criteria:

          1. Active infection or inflammation in the eyes.

          2. Uncontrolled glaucoma.

          3. History of a medical, ocular or non-ocular conditions, resulting in that the study
             medication cannot be safely administered.

          4. Treatment with anti-VEGF intravitreal injection in the study eye within one month
             prior to enrollment.

          5. The use of intraocular corticosteroids in the study eye within the last three months
             prior to enrollment.

          6. Recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug
             release device implantation.

          7. Uncontrolled hypertension.

        Other protocol defined inclusion and exclusion criteria may apply.