bioihbjkbjnl/mcl2 huggingface dataset:
Quetiapine Extended Release Depression Symptoms
Condition: Schizophrenia; Depression
MeSH terms: Depression; Depressive Disorder; Schizophrenia
Intervention: Quetiapine Extended Release; Risperidone
Intervention description: Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day; Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Schizophrenia; Depression; Quetiapine

Summary:

      Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to
      Risperidone, considered as the reference drug for the treatment of depressive symptoms of
      schizophrenia.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent

          -  Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective
             disorder according to DSM-IVTR

          -  Baseline depressive symptoms, assessed by means of HAM-D (21-item) score ≥20, and
             HAM-D item 1 score ≥2

        Exclusion Criteria:

          -  Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder

          -  Patients treated with depot antipsychotic medications within 1 dosing interval before
             day 0; patients treated with other AP oral medications during the trial except for the
             switch period

          -  Use of Clozapine within 28 days prior to enrollment or Clozapine non responders

          -  Any significant clinical disorder that, in the opinion of the investigator, made the
             subject unsuitable to be given treatment with an investigational drug

          -  An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter

          -  Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
             a danger to self or others.
An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: Trabectedin; Doxorubicin; Ifosfamide
Intervention description: Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.; Doxorubicin 60 or 75 mg/m^2 will be given intravenously every 3 weeks until disease progression.; Ifosfamide 6 to 9 g/m^2 will be given intravenously every 3 weeks until disease progression.
Intervention MeSH terms: Doxorubicin; Ifosfamide; Trabectedin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sarcomas; Trabectedin; Doxorubicin; Ifosfamide; YONDELIS

Summary:

      The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to
      standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of
      connective tissue cells) (TRS).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathological diagnosis of translocation-related sarcomas (TRS) including the following
             subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell
             sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma
             (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma,
             myxoid/round cell liposarcoma (MRCL) and synovial sarcoma

          -  Participants must have unresectable locally advanced or metastatic progressive disease
             prior to enrolment

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2

          -  Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within
             normal limits according to institutional standards, as shown by echocardiography or
             scintigraphy multiple-gated acquisition scan [MUGA]

          -  Measurable disease as defined by the radiological (computed tomography [CT] scan and
             magnetic resonance imaging [MRI]) Response Evaluation Criteria in Solid Tumors (RECIST
             v.1.0) guidelines

        Exclusion Criteria:

          -  Known hypersensitivity to any components of the intravenous formulation of trabectedin
             or the comparators

          -  Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is
             available

          -  Brain metastases and/or leptomeningeal metastases, even if treated

          -  Pregnant or lactating women or men and women of reproductive potential who are not
             using effective contraceptive methods

          -  History of another neoplastic disease (except basal cell carcinoma or cervical
             carcinoma in situ adequately treated) unless in remission for five years or more
BLOSSOM: Behavioral Modification and Lorcaserin Second Study for Obesity Management
Condition: Obesity
MeSH terms: Obesity
Intervention: Lorcaserin 10 mg once daily (QD); Lorcaserin 10 mg twice a day (BID); Matching Placebo
Intervention description: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.; Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.; Matching placebo tablet each morning and evening for a duration of 52 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4008.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Obesity; Weight loss; lorcaserin; APD356; BLOSSOM; Hypertension; Dyslipidemia; Sleep apnea; glucose tolerance; cardiovascular disease; Arena

Summary:

      The purpose of this study is to assess the weight loss effect of lorcaserin during and at the
      end of 1 year of treatment in overweight and obese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overweight and/or obese men and women with a body mass index (BMI) 30 to 45 kg/m2 with
             or without a comorbid condition (e.g., hypertension, dyslipidemia, CV disease, glucose
             intolerance, sleep apnea), or 27 to 29.9 kg/m2 with at least one comorbid condition.

          -  Ability to complete a 1 year study

        Exclusion Criteria:

          -  Pregnancy

          -  Diabetes mellitus (type I, II or other)

          -  History of symptomatic heart valve disease

          -  Serious or unstable current or past medical conditions
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
Condition: Vitreomacular Adhesion
MeSH terms: Tissue Adhesions
Intervention: Ocriplasmin 125µg; Placebo
Intervention description: 125µg of ocriplasmin intravitreal injection; Intravitreal injection placebo.
Intervention MeSH terms: Plasminogen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 326.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial will evaluate the safety and efficacy of microplasmin, administered as an
      intravitreal injection, in subjects with focal vitreomacular adhesion. In previously
      performed clinical trials, some patients treated with intravitreal microplasmin have had
      resolution of their underlying condition, including macular hole closure, without need for
      vitrectomy. This clinical trial is justified because the sponsor believes the potential
      benefits outweigh the potential risks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm
             Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior
             vitreous cortex) that in the opinion of the Investigator is related to decreased
             visual function (such as metamorphopsia, decreased visual acuity, or other visual
             complaint)

        Exclusion Criteria:

          -  Any evidence of proliferative retinopathy (including Proliferative Diabetic
             Retinopathy (PDR)) or other ischemic retinopathies involving vitreoretinal vascular
             proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein
             occlusion in the study eye

          -  Subjects with any vitreous hemorrhage or any other vitreous opacification which
             precludes either of the following: visualization of the posterior pole by visual
             inspection OR adequate assessment of the macula by either OCT and/or fluorescein
             angiogram in the study eye

          -  Subjects with macular hole diameter > 400 µm in the study eye

          -  Aphakia in the study eye

          -  High myopia (more than 8D) in study eye (unless prior cataract extraction or
             refractive surgery that makes refraction assessment unreliable for myopia severity
             approximation, in which case axial length >28 mm is an exclusion).
BOTOX® in the Treatment of Upper Facial Lines in Japan
Condition: Upper Facial Rhytides; Crow's Feet Lines; Glabellar Lines; Frown Lines
MeSH terms: Facies
Intervention: botulinum toxin Type A (44U); botulinum toxin Type A (32U)
Intervention description: 44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.; 32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 101.0
Sex: All
Minimum age: 20 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the
      treatment of upper facial lines (Crow's Feet Lines and Frown Lines).
    

Eligibility criteria:

        Inclusion Criteria:

        -Moderate to severe Crow's Feet Lines and Frown Lines

        Exclusion Criteria:

          -  Current or previous botulinum toxin treatment of any serotype

          -  Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis

          -  Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial
             peels, or topical retinoid therapy or hormone cream within 3 months

          -  Laser treatment or phototherapy of the face for medical purposes, blepharoplasty,
             brow-lift or related procedure, periorbital permanent make-up, or oral retinoid
             therapy within one year

          -  Medium-depth or deep facial peels within 5 years

          -  Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift,
             periorbital treatment with fillers, implantation or transplantation)
High Dose CVVHDF Compared to Standard Dose CVVHDF
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Intervention: Standard dose of dialysis; High dose of dialysis
Intervention description: Continuous Venovenous Hemodiafiltration (CVVHDF) effluent dose of 20 ml/kg/hr; Continuous Venovenous Hemodiafiltration (CVVHDF) effluent rate 35 ml/kg/hr
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: CVVHDF Dose Study

Summary:

      In the last three decades, the mortality associated with acute renal failure (ARF) in the ICU
      has remained unchanged at greater than 50%, despite improvements in dialysis technology.

      The primary objective is to determine whether Continuous Veno-Venous Hemodiafiltration
      (CVVHDF) using an ultrafiltration rate of 35 ml/hr/kg (high dose) leads to a greater
      reduction in all-cause ICU mortality compared to standard CVVHDF using an ultrafiltration
      rate of 20 ml/hr/kg.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female > or equal to 19 yrs of age

          -  ARF defined by at least one of the following:

               -  Volume overload from inadequate urine output despite diuretic agents.

               -  Oliguria (urine output < 200 ml/12hrs) despite fluid resuscitation and diuretic
                  administration.

               -  Anuria (urine output < 50 ml/12 hrs).

               -  Acute azotemia (BUN > or equal to 80 mg/dl).

               -  Acute hyperkalemia not responsive to medication (K+ > or equal to 6.5mmol/L)

               -  An increase in serum creatinine of > 2.5 mg/dl from normal values or a sustained
                  rise in serum creatinine of > or equal to 1 mg/dl over baseline.

        Exclusion Criteria

          -  Patients with end stage renal disease

          -  Patients who have had more than one previous dialysis session for acute or chronic
             renal failure during the current hospitalization

          -  Patient weight greater than 125 kg

          -  Patient weight less than 50 kg

          -  Pregnancy

          -  Prisoner

          -  Non-candidacy for continuous renal replacement therapy (CRRT)

          -  Patient/surrogate refusal
Study to Evaluate the Efficacy and Safety of BCX7353 as an Oral Treatment for the Prevention of HAE Attacks in Japan
Condition: Hereditary Angioedema, HAE
MeSH terms: Angioedema; Angioedemas, Hereditary
Intervention: BCX7353 capsules; BCX7353 capsules; Placebo oral capsule
Intervention description: BCX7353 capsules administered orally once daily; BCX7353 capsules administered orally once daily; Matching placebo capsules administered orally once daily
Intervention MeSH terms: Berotralstat
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 19.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: BCX7353

Summary:

      This is a phase 3, multi-center, randomized, double-blind, placebo-controlled trial to
      evaluate the efficacy and safety of oral BCX7353 in preventing acute angioedema attacks in
      patients with Type I and Type II HAE who live in Japan.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  A clinical diagnosis of hereditary angioedema (HAE) Type 1 or Type 2, defined as
             having a C1-INH functional level and a C4 level below the lower limit of the normal
             (LLN) reference range, as assessed during the Screening period.

          -  Access to and ability to use one or more acute medications approved by the relevant
             competent authority for the treatment of acute attacks of HAE

          -  Subjects must be medically appropriate for on-demand treatment as the sole medicinal
             management for their HAE during the study.

          -  Subjects must have a specified number of expert-confirmed attacks during the run-in
             period of 56 days from the Screening visit.

          -  Acceptable effective contraception

          -  Written informed consent

        Key Exclusion Criteria:

          -  Pregnancy or breast-feeding

          -  Any clinically significant medical condition or medical history that, in the opinion
             of the Investigator or Sponsor, would interfere with the subject's safety or ability
             to participate in the study

          -  Any laboratory parameter abnormality that, in the opinion of the Investigator, is
             clinically significant and relevant for this study

          -  Severe hypersensitivity to multiple medicinal products or severe hypersensitivity/
             anaphylaxis with unclear etiology

          -  Use of C1-INH within 14 days or use of androgens or tranexamic acid within 28 days
             prior to the Screening visit for prophylaxis of HAE attacks, or initiation of these
             drugs during the study

          -  Current participation in any other investigational drug study or received another
             investigational drug within 30 days of the Screening visit

          -  Prior enrollment in a BCX7353 study
Phase 3 Study to Evaluate Safety and Efficacy of Iclaprim Versus Vancomycin for ABSSSI: REVIVE-1
Condition: Skin Structures and Soft Tissue Infections
MeSH terms: Soft Tissue Infections
Intervention: iclaprim; vancomycin
Intervention description: Experimental treatment; Active comparator
Intervention MeSH terms: Vancomycin; Iclaprim
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 600.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind study of the efficacy and safety of iclaprim
      compared to vancomycin for the treatment of skin and skin structure infections.
    

Eligibility criteria:

        Inclusion Criteria:

          1. written informed consent;

          2. ≥18 years of age;

          3. a bacterial infection of the skin with a lesion size area of at least 75 cm2;

          4. a major cutaneous abscess, cellulitis/erysipelas, and/or wound infections;

          5. the presence of purulent or seropurulent drainage or at least three signs and symptoms
             of infection (discharge, erythema, swelling, warmth, or pain).

        Exclusion Criteria:

          1. severely impaired arterial blood supply such that amputation of the infected
             anatomical site is likely;

          2. infected diabetic foot ulcers;

          3. infected decubitus ulcers;

          4. necrotizing fasciitis or gangrene;

          5. uncomplicated skin or skin structure infection;

          6. infections associated with a prosthetic device;

          7. suspected or confirmed osteomyelitis;

          8. conditions requiring systemic anti-microbial treatment, prophylaxis, or suppression
             therapy.
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab pegol; Certolizumab pegol; Placebo
Intervention description: 400mg Certolizumab Pegol, Q4W, administered 4-weekly; 400mg Certolizumab Pegol, Q2W, administered 2-weekly; placebo administered 4-weekly in Active 1
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 539.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Crohn's Disease; Certolizumab pegol

Summary:

      To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over
      26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with
      infliximab
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with Crohn's Disease

          -  Previous treatment failure to Infliximab (intolerance and/or no response)

        Exclusion Criteria:

          -  Obstructive intestinal strictures

          -  Recent bowel resection

          -  Proctocolectomy or total colectomy

          -  Current total parenteral nutrition

          -  Short bowel syndrome

          -  All concomitant diseases or pathological conditions that could interfere with Crohn's
             disease assessment or to be harmful for the well being of the patient

          -  Previous clinical trials and previous biological therapy that could interfere with the
             results in the present clinical trial
Rainbow Extension Study
Condition: Retinopathy of Prematurity (ROP)
MeSH terms: Retinal Diseases; Retinopathy of Prematurity; Premature Birth
Intervention: Ranibizumab
Intervention description: 1 intravitreal injection in both eyes on Day 1 (Baseline), with up to 2 re-treatments allowed for each eye if required
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 180.0
Sex: All
Minimum age: 6 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: open-label,; long-term,; extension study,; intravitreal ranibizumab,; laser ablation therapy,; retinopathy of prematurity,; preterm infants,; RAINBOW

Summary:

      The purpose of this study was to evaluate the long term efficacy and safety of intravitreal
      ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy
      of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent from parent(s) or legal guardian(s), in compliance with local
             requirements

          -  The patient successfully completed the core study H2301, as defined by providing
             assessments at the Visit 112 (the last scheduled visit in the core study) or, if
             appropriate, at the last of the additional assessment visits as per protocol in H2301,
             whichever was latest

          -  The patient received study treatment in both eyes at baseline of study H2301

        Exclusion Criteria:

          -  Patient had a medical condition or personal circumstance which precluded study
             participation or compliance with study procedures, as assessed by the Investigator

          -  Patient had been discontinued from the core study H2301 at any time