bioihbjkbjnl/mcl2 huggingface dataset:
In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
Condition: Hemostasis
Intervention: Fibrinogen Concentrate (FC); Cryoprecipitate
Intervention description: The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.; Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 1 Day
Maximum age: 30 Days
Healthy volunteers: No
Keywords: Fibrinogen Concentrate; FC; Cryoprecipitate; Transfusion; in vivo; Open-heart surgery; Cardiopulmonary Bypass; Fibrin Network Structure

Summary:

      This primary aim of this study is to compare the in vivo effects of fibrinogen concentrate
      and cryoprecipitate on the neonatal fibrin network after surgery with cardiopulmonary bypass
      to develop effective and safe strategies for managing coagulopathies in neonates.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Full term neonates (36-42 weeks gestational age)

          2. Infants =< 30 days of age at time of surgery

          3. APGAR score of 6 or greater at 5 minutes after delivery

          4. Neonates undergoing elective cardiac surgery requiring CPB at Children's Healthcare of
             Atlanta

          5. Parents willing to participate and able to understand and sign the provided informed
             consent

        Exclusion Criteria:

          1. Preterm neonates (less than 36 weeks gestation)

          2. Patients undergoing an emergent procedure or surgery not requiring CPB

          3. Patients with personal or family history of a coagulation defect or coagulopathy

          4. Parents unwilling to participate or unable to understand and sign the provided
             informed consent
SleepSure: A Trial to Assess the Effects of Eye Masks and Earplugs on Hospital Inpatient Sleep
Condition: Sleep
Intervention: Ear plugs; Eye Mask; Zopiclone
Intervention description: The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.; The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.; This night sedation will be given to any patient requesting it, in either group
Intervention MeSH terms: Zopiclone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, investigator-blinded, parallel group design
Masking: Single (Investigator)
Enrollment: 206.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: falls; sleep

Summary:

      The aim of this study is to determine whether routinely providing patients admitted to
      hospital with two devices to help sleep - ear plugs, and an eyeshade - leads to patients
      having a better quality of sleep and/or longer, more satisfying sleep.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Be 18 years of age.

          -  Be expected to stay in Oxford University Hospitals National Health Service (NHS)
             Foundation Trust for at least one night.

          -  Be able to understand and use earplugs and eye mask.

          -  Have basic understanding of English reading and writing.

          -  Be considered likely to have the Mental Capacity to give consent for use of personal
             data in the study at the point of filling in the SleepSure Questionnaire (time of
             discharge). Data will not be collected from individuals who are unable to give consent
             with the filling in of the SleepSure questionnaire.

          -  Be expected to be able to fill in the SleepSure Questionnaire at the point of
             discharge with or without assistance.

        Exclusion Criteria:

          -  They have or are expected to have an obvious medical contra-indication to the use of
             earplugs and eye mask at the point of enrollment e.g. eye infection, as per clinical
             judgement of recruiter.

          -  They are unlikely to benefit from the intervention in the judgement of the recruiter
             (i.e. individuals who are deaf and blind).
RESCUE and REVERSE Long-term Follow-up
Condition: Leber Hereditary Optic Neuropathy
MeSH terms: Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Intervention: GS010; Sham Intravitreal Injection
Intervention description: Lenadogene nolparvovec Intravitreal ocular unilateral Injection; Lenadogene nolparvovec Intravitreal ocular unilateral Injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intra patient comparaison
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Heredity Optic Atrophy; Leber Hereditary Optic Atrophy; Leber Hereditary Optic Neuropathy; LHON; Eye Diseases; Hereditary Eye Diseases; Inborn Genetic Disease; Gene Therapy; Intravitreal Injections; Mitochondrial Disease; AAV2 Vectors; Nervous System Diseases; Neurodegenerative Disease; Heredodegenerative Disorders of the Nervous System

Summary:

      The goal of this clinical trial is to assess the long-term safety and efficacy of GS010, a
      gene therapy, and assess the quality of life in subjects with LHON due to the G11778A ND4
      mitochondrial mutation and who were treated in the Rescue or Reverse studies.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject was treated with GS010 IVT injection in either of the RESCUE or REVERSE Phase
             III clinical studies

          -  Subject of legal consent age has provided informed consent; subjects that are not of
             legal consent age have undergone their country-approved clinical trial enrollment
             consent process

        Non-Inclusion Criteria

          -  Subject is unwilling or unable to comply with the protocol requirements

          -  Subject has any medical or psychological condition that, in the opinion of the
             Investigator, may compromise his or her safe participation in the study

          -  Subject is taking or intending to take idebenone during the long-term follow-up study
             period
A Study to Evaluate the Efficacy and Safety of Topical Administration of FMX101 in the Treatment of Moderate-to-Severe Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: FMX101; Vehicle Foam
Intervention description: FMX101, 4% minocycline foam; Vehicle Foam
Intervention MeSH terms: Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1488.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      A Randomized, Double-Blind, Vehicle-Controlled Study to Evaluate the Efficacy and Safety of
      Topical Administration of FMX101 for 12 Weeks in the Treatment of Moderate-to-Severe Acne
      Vulgaris (Study FX2017-22)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Has facial acne vulgaris with:

               1. 20 to 50 inflammatory lesions (papules, pustules, and nodules)

               2. 25 to 100 non-inflammatory lesions (open and closed comedones)

               3. No more than 2 nodules on the face

               4. IGA score of moderate (3) to severe (4)

          2. Willing to use only the supplied non-medicated cleanser (Cetaphil Gentle Skin
             Cleanser) and to refrain from use of any other acne medication, medicated cleanser,
             excessive sun exposure, and tanning booths for the duration of the study.

        Exclusion Criteria:

          1. Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne), or any
             dermatological condition of the face or facial hair (eg, beard, sideburns, mustache)
             that could interfere with the clinical evaluations.

          2. Sunburn on the face.
Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination
Condition: Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Intervention: 13vPnC; PPSV23; 20vPnC
Intervention description: Pneumococcal conjugate vaccine; Pneumococcal polysaccharide vaccine; Pneumococcal conjugate vaccine
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 875.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal
      conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal
      vaccination
    

Eligibility criteria:

        Inclusion Criteria

          1. Male or female adults 65 years of age or greater.

          2. Adults determined by clinical assessment, including medical history and clinical
             judgment, to be eligible for the study, including adults with preexisting stable
             disease, defined as disease not requiring significant change in therapy in the
             previous 6 weeks or hospitalization for worsening disease within 12 weeks before
             receipt of investigational product.

          3. Female subject of nonchildbearing potential; male subject not able to father children
             or who is able to father children and willing to use a highly effective method of
             contraception.

          4. Male or female adults who meet 1 of the following:

               1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to
                  5 years prior to vaccination in the study, and no prior 13vPnC vaccination
                  (Cohort A).

               2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in
                  the study, and no prior PPSV23 vaccination (Cohort B).

               3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or
                  equal to 1 year prior to vaccination in the study) (Cohort C).

        Exclusion Criteria

          1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
             pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
             or without dialysis, clinically unstable cardiac disease, or any other disorder that,
             in the investigator's opinion, excludes the subject from participating in the study.

          2. History of microbiologically proven invasive disease caused by S pneumoniae.
Study of the Safety and Efficacy of Fixed-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder With and Without Anxious Distress
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Intervention: Placebo + ADT; Brexpiprazole +ADT
Intervention description: Placebo + ADT Placebo + FDA Approved Antidepressant (ADT); Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 837.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment; Anxious Distress

Summary:

      The purpose of this study is to assess the tolerability, safety, and efficacy of
      brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD
      with and without anxious distress
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and Female subjects between 18-65 years of age, with diagnosis of major
             depressive disorder with or without anxious distress

          -  Current depressive episode must be at least 8 weeks in duration

        Exclusion Criteria:

          -  Subjects with a history of Neuroleptic Malignant Syndrome or Serotonin Syndrome

          -  Subjects who report an inadequate response to more than 3 antidepressant treatments in
             the current episode

          -  Subjects with a current Axis I diagnosis of: Delirium, dementia, amnestic or other
             cognitive disorder, Schizophrenia, schizoaffective disorder, or other psychotic
             disorder, Bipolar I or II disorder
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
Condition: Haemophilus Influenzae Type b; Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis
MeSH terms: Diphtheria; Poliomyelitis
Intervention: DTPa-HBV-IPV/Hib; DTPa-IPV/Hib vaccine
Intervention description: 1 intramuscular injection (3rd study vaccine dose); 3 intramuscular injections (1st, 2nd and 4th vaccine dose)
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 702.0
Sex: All
Minimum age: 11 Weeks
Maximum age: 17 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib
      vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK
      Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Eligibility criteria:

        Inclusion criteria

          -  Subjects must have been enrolled in the Rota-028 study.

          -  Subjects for whom the investigator believes that their parents/guardians can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  A male or female between, and including, 11 and 17 weeks of age at the time of the
             first vaccination.

          -  Written informed consent obtained from the parent or guardian of the subject.

          -  Free of obvious health problems as established by medical history and clinical
             examination before entering into the study.

          -  Subjects should have received two doses of hepatitis B vaccine: at birth and at
             approximately one month of age.

        Exclusion criteria

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs during the study period.

          -  Planned administration/ administration of a vaccine not foreseen by the study protocol
             during the period starting from 30 days before each dose of the vaccine and ending 30
             days after.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, including
             human immunodeficiency virus (HIV) infection.

          -  A family history of congenital or hereditary immunodeficiency.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Acute disease at the time of enrolment.

          -  Administration of immunoglobulins and/or any blood products since birth or planned
             administration during the study period.
Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Condition: Kidney Neoplasms
MeSH terms: Carcinoma, Renal Cell; Kidney Neoplasms
Intervention: Axitinib (AG-013736); Sorafenib
Intervention description: axitinib will be given at a starting dose of 5 mg BID with continuous dosing; sorafenib will be given at a dose of 400 mg BID continuous dosing
Intervention MeSH terms: Sorafenib; Axitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 492.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer

Summary:

      The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in
      delaying tumor progression in patients with metastatic renal cell cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented metastatic renal cell cancer with a component of clear cell
             histology.

          -  Evidence of measurable disease.

          -  Patients with mRCC must have received no prior systemic first-line therapy or must
             have progressive disease per RECIST (version 1.0) after one prior systemic first line
             regimen for metastatic disease containing sunitinib, cytokine(s), or both.

        Exclusion Criteria:

          -  Prior treatment for metastatic renal cell cancer with more that one systemic first
             line therapy.

          -  Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy
Condition: Painful Diabetic Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies; Pain
Intervention: Lacosamide
Intervention description: Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Painful diabetic neuropathy; Lacosamide

Summary:

      The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a
      longer period of time and whether it continues to work well to treat pain.

      Subjects will receive lacosamide at a dose that will be individually determined to be the one
      that provides most pain relief with the least side effects. The maximum dose will be
      600mg/day. Subjects may participate in this trial until October 2007. This time may be
      extended to allow them to participate until lacosamide is commercially available.

      If a subject meet the requirements for the study at Visit 1 and after a two weeks phase
      without trial medication, s/he enters a Titration Phase to determine the personal optimal
      dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will
      be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks
      thereafter.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion Criteria:

          -  Painful diabetic neuropathy

        Exclusion Criteria:

          -  no clinically relevant liver enzyme abnormalities and impaired renal function, no
             cardiac abnormalities, no pregnant or nursing females

        Exclusion Criteria:
A Phase 3, Vehicle-controlled Efficacy and Safety Study of IDP-123 Lotion in the Treatment of Acne Vulgaris (302)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-123 Lotion; IDP-123 Vehicle Lotion
Intervention description: Tazarotene 0.045% Lotion; Vehicle Lotion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 801.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      This is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed
      to assess the safety, efficacy, and tolerability of IDP-123 Lotion in comparison with IDP-123
      Vehicle Lotion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older;

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit);

          3. Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global
             Severity assessment at the baseline visit;

          4. Subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20 but no more than 50;

          5. Subjects with facial acne non-inflammatory lesion (open and closed comedones) count no
             less than 25 but no more than 100;

          6. Subjects with two or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study;

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis,
             eczema;

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive;

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments;

          5. Subjects with more than two (2) facial nodules;

          6. Evidence or history of cosmetic-related acne