bioihbjkbjnl/mcl2 huggingface dataset:
Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease
Condition: Advanced Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Levodopa-Carbidopa Intestinal Gel (LCIG); CADD-Legacy® 1400 ambulatory infusion pump; Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)
Intervention description: LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.; Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.; All participants previously had a PEG-J placed in one of the prior LCIG studies.
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 262.0
Sex: All
Minimum age: 30 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: levodopa/carbidopa intestinal gel; Severe Motor Fluctuations; Levodopa; Carbidopa; Parkinson's Disease; Dyskinesia

Summary:

      The primary objective of this study is to provide continued access to levodopa-carbidopa
      intestinal gel (LCIG), to participants who have already participated in an open-label
      efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study
      S187.3.004 [NCT00335153]).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant should have completed participation in Study S187.3.003 or S187.3.004;
             and, in the opinion of the Principal Investigator, would benefit from long-term
             treatment with LCIG.

          -  For Canada, participants will be allowed to participate in the S187.3.005 study with a
             minimum of 6 months of exposure to LCIG in the S187.3.004 study.

          -  The participant must be able to understand the nature of the study and must provide
             written informed consent prior to the conduct of any study related procedures. If the
             participant does not have the capacity to provide informed consent, full informed
             consent must be obtained from the participant's legally authorized representative.
             Consenting will be performed according to local regulations.

        Exclusion Criteria:

          -  Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be
             clinically significant and which could interfere with the participant's participation
             in the study.
Participant Reported Outcomes With Use of Trifarotene 50 μg/g Cream in the Treatment of Moderate Facial and Truncal Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Trifarotene
Intervention description: Topical Cream
Intervention MeSH terms: Trifarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      Participant Reported Outcomes with use of Trifarotene 50 μg/g Cream in participants with
      Moderate Facial and Truncal Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant was a male or female, 9 years of age or older, at Screening visit.

          -  The participant had moderate acne at Screening and Baseline.

          -  The participant was a female of non childbearing potential.

          -  The participant was a female of childbearing potential with a negative pregnancy test
             and who was strictly abstinent or who agreed to use an effective and approved
             contraceptive method for the duration of the study and at least 1 months after the
             last study drug application.

        Exclusion Criteria:

          -  The participant had severe forms of acne (e.g., acne conglobate, acne fulminant) or
             secondary acne form (e.g., chloracne, drug induced acne, etc.).

          -  The participant had any uncontrolled or serious disease or any medical or surgical
             condition that may either interfere with the interpretation of the trial results
             and/or put the participant at significant risk (according to the Investigator's
             judgment) if the participant took part to the trial.

          -  The participant had been exposed to excessive ultraviolet (UV) radiation within one
             month prior to the Baseline visit or the participant was planning intense UV exposure
             during the study (i.ed, occupational exposure to the sun, sunbathing, tanning salon
             use, phototherapy, etc.).

          -  The participant was unwilling to refrain from use of prohibited medication during the
             Clinical Trial.
High Dose Oxytocin Nasal Spray for Treatment of Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: Oxytocin; Placebo nasal spray
Intervention description: The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day; A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.
Intervention MeSH terms: Oxytocin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for
      treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly
      reduce tinnitus severity and disability.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration.

          -  Subjects must have had a normal otolaryngologic evaluation within the past year with
             no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of > 16.

          -  Subjects must have tinnitus loudness rating of >4/10.

        Exclusion Criteria:

          -  Subjects who are being treated for tinnitus < 6 months due to the acute nature of
             their condition

          -  Subjects who have a slight handicap according to the Tinnitus Handicap Inventory
             Severity Scale.

          -  Those with tinnitus of a muscular or vascular etiology

          -  Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin
             nasal spray.

          -  Women of childbearing age will not be approached for participation due to the risk of
             oxytocin-induced uterine contractions.

          -  Subjects who suffer from migraines.

          -  Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe
             renal disease.
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With PNH
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: APL-2
Intervention description: Complement (C3) Inhibitor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluation of the Efficacy and Safety of Pegcetacoplan in Patients with Paroxysmal Nocturnal
      Hemoglobinuria .
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be at least 18 years old (inclusive).

          -  Have LDH ≥1.5 x ULN at the screening visit.

          -  Have PNH diagnosis, confirmed by high sensitivity flow cytometry (granulocyte or
             monocyte clone >10%).

          -  Have Hb less than the lower limit of normal (LLN) at the screening visit.

          -  Have ferritin greater than/equal to the LLN, or total iron binding capacity (TIBC)
             less than/equal to ULN at the screening visit, based on central laboratory reference
             ranges. If a subject is receiving iron supplements at screening, the Investigator must
             ensure that the subject's dose has been stable for 4 weeks prior to screening, and it
             must be maintained throughout the study. Subjects not receiving iron at screening must
             not start iron supplementation during the course of the study.

          -  Body mass index (BMI) ≤ 35 kg/m2 at the screening visit.

          -  Have a platelet count of >50,000/mm3 at the screening visit.

          -  Have an absolute neutrophil count >500/mm3 at the screening visit.

        Exclusion Criteria:

          -  Treatment with any complement inhibitor (eg, eculizumab) within 3 months prior to
             screening.

          -  Hereditary complement deficiency.

          -  History of bone marrow transplantation.

          -  Concomitant use of any of the following medications is prohibited if not on a stable
             regimen for the time period indicated below prior to screening:

               -  Erythropoietin or immunosuppressants for at least 8 weeks

               -  Systemic corticosteroids for at least 4 weeks

               -  Vitamin K antagonists (eg, warfarin) with a stable international normalized ratio
                  (INR) for at least 4 weeks

               -  Iron supplements, vitamin B12, or folic acid for at least 4 weeks

               -  Low-molecular-weight heparin for at least 4 weeks
A Study to Assess Efficacy and Safety of HL036 in Subjects With Dry Eyes
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: HL036 Ophthalmic Solution; Placebo
Intervention description: HL036 Ophthalmic Solution; Placebo vehicle solution
Intervention MeSH terms: Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 637.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study was to compare the safety and efficacy of 0.25% HL036 Ophthalmic
      Solutions to placebo for the treatment of the signs and symptoms of dry eye.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a patient-reported history of dry eye for at least 6 months prior to Visit 1

          -  Be willing and able to comply with all study procedures

          -  Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2

        Exclusion Criteria:

          -  Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active
             ocular inflammation at Visit 1

          -  Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses
             during the study

          -  Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the
             last 12 months

          -  Have any previous experience using HL036
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Vortioxetine 10 mg/day; Vortioxetine 20 mg/day; Fluoxetine 20mg/day; Placebo
Intervention description: 10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed; Encapsulated tablet, orally
Intervention MeSH terms: Vortioxetine; Fluoxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 683.0
Sex: All
Minimum age: 7 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: paediatric

Summary:

      Investigation of the efficacy and safety of a new potential treatment of Major depressive
      disorder (MDD) in paediatric participants (age 7 to 11 years).
    

Eligibility criteria:

        Inclusion Criteria:

          1. The participant has MDD, diagnosed according to Diagnostic and Statistical Manual of
             Mental Disorders, 5th Edition (DSM-5™).

          2. The participant has a CDRS-R total score ≥45 at the Screening Visit and the Baseline.

          3. The participant has a CGI-S score ≥4 at the Screening Visit and the Baseline.

          4. The participant is a boy or girl, aged ≥7 and <12 years at Screening Visit

          5. The participant has provided assent to participation and parent(s)/legal
             representative (s) signed the Informed Consent Form.

        Exclusion Criteria:

          1. The participant has participated in a clinical study <30 days prior to the Screening
             Visit.

          2. The participant has previously participated in a study with vortioxetine.

        Other protocol defined inclusion and exclusion criteria may apply
TELESTAR (Telotristat Etiprate for Somatostatin Analogue Not Adequately Controlled Carcinoid Syndrome)
Condition: Carcinoid Syndrome
MeSH terms: Carcinoid Tumor; Malignant Carcinoid Syndrome; Syndrome; Serotonin Syndrome
Intervention: Telotristat etiprate; Placebo-matching telotristat etiprate
Intervention description: Telotristat etiprate tablets.; Placebo-matching telotristat etiprate tablets.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to one of three treatment arms in the double-blind treatment period. After completion of the double-blind treatment period, participants entered an open-label treatment period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of the study is to confirm that at least 1 or more doses of telotristat
      etiprate compared to placebo is effective in reducing the number of daily bowel movements
      (BMs) from baseline averaged over the 12-week double-blind portion (Treatment Period) of the
      trial in patients not adequately controlled by current SSA therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histopathologically-confirmed, well-differentiated metastatic neuroendocrine tumor

          -  Documented history of carcinoid syndrome and currently experiencing ≥4 bowel movements
             per day during the Run-in period

          -  Currently receiving stable-dose somatostatin analog (SSA) therapy

          -  Minimum dose of long-acting release (LAR) or depot SSA therapy

               -  Octreotide LAR at 30 mg every 4 weeks

               -  Lanreotide Depot at 120 mg every 4 weeks

               -  Patients who cannot tolerate SSA therapy at a level indicated above will be
                  allowed to enter at their highest tolerated dose

          -  Ability and willingness to provide written informed consent

        Exclusion Criteria:

          -  Presence of diarrhea attributed to any condition(s) other than carcinoid syndrome

          -  Karnofsky Performance status ≤60%

          -  Treatment with any tumor directed therapy, including interferon, chemotherapy,
             mechanistic target of rapamycin (mTOR) inhibitors <4 weeks prior to Screening, or
             hepatic embolization, radiotherapy, radiolabelled SSA, and/or tumor debulking <12
             weeks prior to Screening

          -  History of short bowel syndrome (SBS)

          -  Clinically significant cardiac arrhythmia, bradycardia, tachycardia that would
             compromise patient safety or the outcome of the study

          -  Previous exposure to telotristat etiprate
A Study Comparing Cardiovascular Effects of Ticagrelor Versus Placebo in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Ticagrelor 60 mg; Ticagrelor placebo
Intervention description: Ticagrelor 60 mg bd taken orally as tablets; Ticagrelor placebo bd taken orally as tablets
Intervention MeSH terms: Ticagrelor
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 19271.0
Sex: All
Minimum age: 50 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Diabetes; Coronary artery disease; Outcome; Prevention; Antiplatelet

Summary:

      The purpose of this study is to compare the effect of ticagrelor versus placebo in patients
      with Type 2 Diabetes Mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

        Men or women ≥50 years of age with type 2 diabetes mellitus on treatment with a glucose
        lowering medication since at least 6 months, and either documented coronary artery
        occlusive disease or previous revascularization of a coronary artery.

        Key Exclusion Criteria:

        History of myocardial infarction or any stroke; planned treatment with agents inhibiting
        blood clotting; planned use of ASA/Aspirin at doses above 150 mg daily; planned coronary,
        cerebrovascular, or peripheral arterial revascularization; patients with known bleeding
        disorders and patients who need chronic oral anticoagulant therapy or chronic
        low-molecular-weight heparin; history of intracranial bleeding at any time, or a history of
        bleeding from the gastrointestinal tract within the last 6 months or a major surgery within
        the last 30 days; patients with known severe liver disease or with kidney failure requiring
        dialysis
STREAM-Strategic Reperfusion (With Tenecteplase and Antithrombotic Treatment) Early After Myocardial Infarction
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: primary PCI; enoxaparin; catheterisation; tenecteplase; clopidogrel
Intervention description: Standard primary PCI; Adjunctive treatment; Routine or rescue coronary intervention; Single, weight-adjusted i.v. bolus of tenecteplase; Adjunctive treatment
Intervention MeSH terms: Enoxaparin; Tenecteplase; Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1899.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study aims at evaluating, in a proof of concept approach, the outcome of patients
      presenting with acute ST-elevation myocardial infarction within 3 hours of symptom onset in
      either a pre-hospital setting or community hospital emergency room without a PCI facility.
      Following randomisation a strategy of early tenecteplase and additional antiplatelet and
      antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary
      intervention as appropriate (or by rescue coronary intervention if required) in Group A will
      be compared to primary PCI performed according to local standards in Group B.

      The study is exploratory in nature and will examine this medical question. The efficacy and
      safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before
      30 days following randomisation will be evaluated.

      All clinical endpoints of main interest will be assessed as single or composite endpoints for
      evaluation of the trial objective. All statistical tests are of exploratory nature based on
      descriptive p-values for formal statistical hypotheses generation.
    

Eligibility criteria:

        Inclusion criteria:

          1. Age equal or greater than 18 years

          2. Onset of symptoms < 3 hours prior to randomisation 3.12-lead ECG indicative of an
             acute STEMI

        4.Informed consent received

        Exclusion criteria:

        Medical history, procedures, medication administration or the presence of factors that
        would in general predispose to bleeding events and/or the inability to evaluate the study
        primary endpoint