bioihbjkbjnl/mcl2 huggingface dataset:
Study Looking at Combination Therapy (Sitaxsentan+Sildenafil) Vs. Monotherapy (Sitaxsentan Alone) SR-PAAS -Sitaxsentan Efficacy And Safety Trial With A Randomized Prospective Assessment Of Adding Sildenafil
Condition: Pulmonary Arterial Hypertension; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Sitaxsentan; Sitaxsentan and Sildenafil
Intervention description: Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day; Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
Intervention MeSH terms: Sildenafil Citrate; Sitaxsentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 131.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: endothelin receptor antagonist (ETRA); Sitaxsentan

Summary:

      As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies
      are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated
      the controlled safety/efficacy database of the combination is limited.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously enrolled in B1321001 (NCT00795639) and completed the 12-week study as
             planned.

        Exclusion Criteria:

          -  Treated with an investigational drug, other than sitaxsentan sodium in B1321001
             (NCT00795639), or device that has not received regulatory approval within the 30 days
             prior to Baseline/Day 1 or during the study.
Mapracorat Ophthalmic Suspension, 3% for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Cataract; Inflammation; Surgery
MeSH terms: Cataract; Inflammation
Intervention: Mapracorat; Vehicle
Intervention description: 1 drop of study medication into the study eye four times daily (QID) for 14 days; 1 drop of vehicle into the study eye QID for 14 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this clinical study is to compare the safety and efficacy of mapracorat
      ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation
      and pain following cataract surgery. Participants from the United States and Canada will be
      recruited for this study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are candidates for routine, uncomplicated cataract surgery.

          -  Subjects who, in the Investigator's opinion, have potential postoperative pinhole
             Snellen visual acuity (VA) of at least 20/200 in the study eye.

          -  Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following
             cataract surgery (postoperative day 1).

        Exclusion Criteria:

          -  Subjects who have a severe/serious ocular condition or history/presence of chronic
             generalized systemic disease that the Investigator feels might increase the risk to
             the subject or confound the result(s) of the study.

          -  Any intraocular inflammation in either eye (cells or flare score greater than Grade 0
             at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the
             Screening Visit.

          -  Presence of active external ocular disease: infection or inflammation of the study
             eye.

          -  Subjects who have known hypersensitivity or contraindication to the study drug(s) or
             their components.

          -  Subjects who currently require or are expected to require treatment with any
             medication listed as a disallowed medication per the Disallowed Therapy section of the
             protocol.
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
Condition: Geographic Atrophy; Macular Degeneration
MeSH terms: Macular Degeneration; Geographic Atrophy; Atrophy
Intervention: Avacincaptad Pegol; Sham
Intervention description: Avacincaptad Pegol Intravitreal Injection; Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking description: Participant, "Evaluating" Investigator, Reading Center Personnel, and Sponsor Personnel are masked
Enrollment: 448.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Geographic Atrophy (GA); Age-related Macular Degeneration; AMD; Zimura; Complement C5 inhibitor; avacincaptad pegol; IZERVAY

Summary:

      The objectives of this study are to evaluate the safety and efficacy of Zimura (avacincaptad
      pegol) intravitreal administration in patients with geographic atrophy secondary to
      age-related macular degeneration (AMD)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Diagnosis of Non-foveal GA secondary to dry AMD

        Exclusion Criteria:

          -  Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any
             indication in either eye, except oral supplements of vitamins and minerals

          -  Any intraocular surgery or thermal laser within 3 months of trial entry.

          -  Any prior thermal laser in the macular region, regardless of indication

          -  Any ocular or periocular infection (including blepharitis), or ocular surface
             inflammation in the past 12 weeks.

          -  Previous therapeutic radiation in the region of the study eye

          -  Any sign of diabetic retinopathy in either eye
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: BMS-986165; Placebo; Apremilast
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Apremilast; Deucravacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1020.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the experimental medication BMS-986165 compared
      to placebo and a currently available treatment in participants with moderate to severe plaque
      psoriasis.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Plaque psoriasis for at least 6 months

          -  Moderate to severe disease

          -  Candidate for phototherapy or systemic therapy

        Exclusion Criteria:

          -  Other forms of psoriasis

          -  History of recent infection

          -  Prior exposure to BMS-986165 or active comparator

        Other protocol defined inclusion/exclusion criteria could apply
Brief Strategic Family Therapy for Adolescent Drug Abusers
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Intervention: Brief Strategic Family Therapy (BSFT); Treatment as Usual
Intervention description: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period during the Main Study, and up to 8 "booster" sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school).; TAU varies depending on site, however each will offer services that include at least 1 therapy session (individual or group therapy) per week during the Main Study, as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 480.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: BSFT; Family Therapy; Adolescents; Substance Abuse

Summary:

      The purpose of this study is to compare Brief Strategic Family Therapy (BSFT) for Adolescent
      Drug Abusers to treatment as usual (TAU).

      An additional follow up assessment, funded by an American Recovery & Reinvestment Act (ARRA)
      grant, was completed 5 years post randomization in order to examine the long term effects of
      outpatient treatments for illicit drug using adolescents.
    

Eligibility criteria:

        Main Study:

        Inclusion Criteria:

          -  adolescents ages 12 to 17

          -  used any illicit drugs (other than alcohol and tobacco) in the 30-day period

          -  live with or intend to live with a formal or informal family

        Exclusion Criteria:

          -  suicidal or homicidal ideation.

        Follow Up Study:

        Inclusion Criteria:

          -  youth must have signed consent during the main study to be approached for future
             research

          -  currently 18 years old or older
Evaluation of Safety and Efficacy of Dapagliflozin in Subjects With Type 2 Diabetes Who Have Inadequate Glycaemic Control on Background Combination of Metformin and Sulfonylurea
Condition: Type 2 Diabetes Mellitus; High HbA1c Level; Inadequate Glycaemic Control
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: dapagliflozin; placebo
Intervention description: 10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period; matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: dapagliflozin; diabetes; hyperglycaemia

Summary:

      This study intends to compare the efficacy and safety of dapagliflozin versus placebo in
      patients with type 2 diabetes who have inadequate glycaemic control on a background
      combination of metformin and sulfonylurea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus

          -  Men or women age ≥ 18 years old

          -  Stable dose combination of metformin and sulfonylurea

          -  HbA1c ≥7.7% and ≤11.0%

        Exclusion Criteria:

          -  Type 1 diabetes mellitus or diabetes insipidus

          -  Recent cardiovascular events

          -  Kidney or urological disorders

          -  Hepatic disorders
A Study Comparing the Effect of Atomoxetine Versus Other Standard Care Therapy on the Long Term Functioning in Attention-Deficit/Hyperactivity Disorder (ADHD) Children and Adolescents
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Other standard therapy for ADHD
Intervention description: 0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension; Any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 399.0
Sex: All
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate that atomoxetine is superior to other early
      standard therapy (any treatment that investigator considers is appropriate to initiate for
      the treatment of Attention-Deficit/Hyperactivity Disorder [ADHD]) on the long term
      functioning in approximately 400 children and adolescents with ADHD. Patients will be
      pharmacological naïve prior to entry into the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria:

               -  6 to 16 years old

               -  Diagnosis of ADHD according to Diagnostic and Statistical Manual of Mental
                  Disorders Fourth Edition (DSM IV) confirmed by Kiddie Schedule for Affective
                  Disorders and Schizophrenia for School Aged Children-Present and Lifetime Version
                  (SADS PL)

               -  Pharmacological naïve

               -  Normal intelligence as assessed by investigator

               -  Each patient (and/or legally authorized patient representative where required by
                  local law) must understand the nature of the study and must sign an Informed
                  Consent Document.

        Exclusion Criteria:

          -  Exclusion criteria

               -  History of bipolar disorder, any history of psychosis or autism spectrum disorder

               -  History of any seizure disorder

               -  Significant prior or current medical conditions

               -  History of alcohol or drug abuse within the past 3 months

               -  Patients who are taking concurrently any of the excluded medications in the
                  study.
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hypothermia; Wounds and Injuries
Intervention: Hypothermia
Intervention description: Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 232.0
Sex: All
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Traumatic Brain Injury; Hypothermia

Summary:

      Induction of hypothermia to < 35˚C by < 2.5 hours after severe traumatic brain injury,
      reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will
      result in an increased number of patients with good outcomes at six months after injury
      compared to patients randomized to normothermia.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8
             (motor 1-5)

          2. Estimated or known age > 16 and < 45 years old

          3. Time of Injury within 2.5hrs of arrival at hospital

        Exclusion Criteria:

          1. GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid
             hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization

          2. GCS = 3 AND bilaterally non-reactive pupils

          3. Abbreviated Injury Score (AIS) > 4 for any body area except head

          4. Positive abdominal ultrasound or CT scan

          5. Persistent hypotension (systolic blood pressure < 110mmHGg)

          6. Persistent hypoxia (O2 Saturation < 94%)

          7. Positive pregnancy test

          8. Injured greater than 2.5 hours from hospital arrival

          9. Pre-existing medical conditions, if known
Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV Neuropathy
Condition: HIV Infections; Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases
Intervention: pregabalin; Placebo
Intervention description: 75mg BID (can be titrated up to 150mg BID on day 4 based on individual response and up to 300mg BID at the end of week 1, visit 3 and end of week 2, visit 4); Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 302.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study to determine if pregabalin is more effective than placebo in treating subjects with
      nerve pain associated with HIV neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with confirmed diagnosis of HIV infection

          -  HIV-associated neuropathic pain (nerve pain) for at least 3 months prior to study
             start

          -  subjects with moderate to severe pain

          -  subjects on stable HIV and pain medications (some medications are not allowed to be
             taken while participating in the study).

        Exclusion Criteria:

          -  Pregnant or breast feeding females

          -  subjects using street drugs or alcohol abusers during the study

          -  subject's on anti-diabetic medications

          -  use of neuroregenerative agents or neurotoxic chemotherapeutic agents 3 months prior
             to study start and throughout the study

          -  use of neurotoxic drugs (other than D-drugs) within a month prior to study start and
             throughout the study.
An Open-label, Multinational, Multicenter, Follow-up Study to Evaluate the Long-term Safety and Efficacy of Brivaracetam
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Subjects will begin at a recommended dose of Brivaracetam 100 mg/day. Subjects will continue treatment at a dose up to a maximum of 200 mg/day with a twice per day administration. Up- and down-titration steps may be performed in steps of a maximum of 50 mg/day on a weekly basis. Full down-titration should include a one week step on 20 mg/day. The study medication will come in 10 mg and 25 mg tablet strengths.
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 108.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Monotherapy; Partial Onset Seizures

Summary:

      The Sponsor wishes to develop brivaracetam as an anti-epileptic treatment in subjects 16
      years and older with epilepsy. This study permits continued access to treatment for subjects
      who participated in a previous epilepsy study. The study will explore the long-term safety
      and efficacy of brivaracetam.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with epilepsy who participated in previous brivaracetam trials which allow
             access to the present trial.

          -  Subjects from whom the Investigator believes a reasonable potential benefit from the
             long-term administration of brivaracetam may be expected.

        Exclusion Criteria:

        • Severe medical, neurological and psychiatric disorders, including current suicidal
        ideation or behaviour, or laboratory values which may have an impact on the safety of the
        subject, as determined by the investigator.
A Trial Evaluating Compatibility and Safety of FIAsp and Insulin Aspart With an External Continuous Subcutaneous Insulin Infusion System in Adult Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Faster-acting insulin aspart; insulin aspart
Intervention description: Administered subcutaneously (s.c., under the skin). Dose individually adjusted.; Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and the United States of America (USA). The aim of this
      trial is to evaluate compatibility and safety of FIAsp (faster-acting insulin aspart) and
      insulin aspart (NovoRapid®) with an external continuous subcutaneous insulin infusion (CSII)
      system in adult subjects with type 1 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age at least 18 years at the time of signing inform consent

          -  Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months at the time of
             screening (Visit 1)

          -  Currently treated with insulin aspart, insulin lispro or insulin gluisine for at least
             3 months prior to screening (Visit 1)

          -  Using an external CSII system for the previous 6 months prior to screening (Visit 1)

          -  HbA1c (glycosylated haemoglobin) below or equal to 9.0% as assessed by central
             laboratory

          -  Body Mass Index (BMI) 20.0-35.0 kg/m^2

        Exclusion Criteria:

          -  History of diabetic ketoacidosis (DKA) episodes requiring hospitalization within 6
             months prior to screening (Visit 1)

          -  History of abscess at the infusion site within 6 months prior to screening (Visit 1)

          -  Hypoglycaemic unawareness as judged by the Investigator or history of severe
             hypoglycaemic episodes requiring hospitalization within the last 6 months prior to
             screening (Visit 1)