bioihbjkbjnl/mcl2 huggingface dataset:
Red Cell Storage Duration Study
Condition: Cardiac Surgery; Erythrocyte Transfusion
Intervention: Red blood cell units stored <= 10 days; Red blood cell units stored >= 21 days
Intervention description: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.; Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1481.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Cardiac surgery; Red blood cell; Transfusion

Summary:

      The RECESS study will compare the effects of transfusing red blood cell units stored <= 10
      days vs. red blood cell units stored >= 21 days, in patients who are undergoing complex
      cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis
      is that there is a clinically important difference between the effects of shorter-storage red
      cell units and longer-storage red cell units on clinical outcomes and mortality risk.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 12 years old

          -  >= 40 kg body weight

          -  Scheduled complex cardiac surgery with planned use of median sternotomy.

          -  Patients ≥ 18 years must have a Transfusion Risk Understanding Scoring Tool (TRUST)
             probability score ≥ 3

        Exclusion Criteria:

          -  Refusal of blood products

          -  Planned surgery is minimally invasive

          -  Known transfusion reaction history

          -  Requirement for washed products, volume reduced products, or products with additive
             solution removed

          -  Expected residual cyanosis with O2 saturation < 90

          -  Left ventricular assist device (LVAD) or Extracorporeal membrane oxygenation (ECMO)
             support pre-operatively or planned need post-operatively

          -  Cardiogenic shock requiring pre-operative placement of an Intra-aortic balloon pump
             (IABP) (IABP done for unstable angina or prophylactically for low ejection fraction is
             not excluded)

          -  Planned Deep Hypothermic Circulatory Arrest (DHCA)

          -  Renal dysfunction requiring pre-operative renal replacement therapies such as
             hemodialysis (HD) or continuous venovenous hemofiltration (CVVH)

          -  Planned use of alternative to heparin, e.g. bivalirudin

          -  Planned use of autologous or directed donations

          -  Prior RBC transfusion during hospitalization for the study-qualifying surgery

          -  Prior randomization into the RECESS study
Topical Ruxolitinib Evaluation in Vitiligo Study 1 (TRuE-V1)
Condition: Non-segmental Vitiligo
MeSH terms: Vitiligo
Intervention: Ruxolitinib cream; Vehicle
Intervention description: Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Vehicle cream is a topical formulation applied as a thin film to affected areas.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will receive ruxolitinib cream or vehicle for 24 weeks, after which they will be offered the opportunity to continue in the treatment extension period. Participants initially randomized to vehicle will be crossed over to active drug, and participants treated with ruxolitinib cream will receive an additional 28 weeks of treatment with ruxolitinib cream.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 330.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Vitiligo; non-segmental; JAK inhibitor

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in
      adolescent and adult participants with non-segmental vitiligo for whom total body involved
      vitiligo area (facial and nonfacial) does not exceed 10% body surface area (BSA).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Clinical diagnosis of non-segmental vitiligo with depigmented area including ≥ 0.5%
             BSA on the face, ≥ 0.5 F-VASI, ≥ 3% BSA on nonfacial areas, ≥ 3 T-VASI, and total body
             vitiligo area (facial and nonfacial) not exceeding 10% BSA.

          -  Agree to discontinue all agents used to treat vitiligo from screening through the
             final safety follow-up visit. Over-the-counter preparations deemed acceptable by the
             investigator and camouflage makeups are permitted.

          -  Must be willing to take appropriate contraceptive measures to avoid pregnancy or
             fathering a child for the duration of study participation.

        Key Exclusion Criteria:

          -  No pigmented hair within any of the vitiligo areas on the face.

          -  Other forms of vitiligo (eg, segmental) or other differential diagnosis of vitiligo or
             other skin depigmentation disorders (eg, piebaldism, pityriasis alba, leprosy,
             postinflammatory hypopigmentation, progressive macule hypomelanosis, nevus anemicus,
             chemical leukoderma, and tinea versicolor).

          -  Have used depigmentation treatments (eg, monobenzone) for past treatment of vitiligo
             or other pigmented areas.

          -  Use of protocol-defined treatments within the indicated washout period before
             baseline.
Long-term Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Cariprazine; Antidepressant Therapy (ADT)
Intervention description: Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.; ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug
Intervention MeSH terms: Cariprazine; Antidepressive Agents
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 442.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

Summary:

      The objective of this study is to evaluate the long-term safety and tolerability of
      cariprazine as an adjunctive treatment to antidepressant therapy (ADT) in patients with Major
      Depressive Disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have provided consent prior to any study specific procedures

          -  Meets the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text
             Revision (DSM-IV-TR) criteria for MDD

          -  New patients must have ongoing inadequate response to protocol allowed ADTs as
             reported in Antidepressant Treatment Response Questionnaire (ATRQ)

          -  For rollover patients from RGH-MD-72 [NCT01715805], completion of Study RGH-MD-72
             (either double-blind or single-blind treatment periods) with continued ADT treatment.

        Exclusion Criteria:

          -  Patients who do not meet the DSM-IV-TR criteria for MDD.
Moxifloxacin in the Prevention of Bacteremia After High-dose Chemotherapy and Transplantation of Peripheral Stem Cells
Condition: Hodgkin Disease; Non-Hodgkin Lymphoma; Multiple Myeloma; Bacteremia
MeSH terms: Bacteremia; Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease
Intervention: moxifloxacin; placebo
Intervention description: 400 mg p.o. per day; one tablet per day p.o.
Intervention MeSH terms: Moxifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: prophylaxis; bacteremia; moxifloxacin; stem cell transplantation; Hodgkin disease; non-Hodgkin lymphoma; multiple myeloma; solid tumor; autologous stem cell transplantation

Summary:

      This study investigates whether the prophylactic use of moxifloxacin during high-dose
      chemotherapy followed by autologous stem cell transplantation reduces the incidence of
      clinically significant bacteremia.

      Further investigations include time to occurrence of fever, duration of fever, overall
      survival and antibiotic sensitivity of blood isolates.
    

Eligibility criteria:

        Inclusion Criteria:

          -  High-dose chemotherapy followed by peripheral autologous stem cell transplantation

          -  Underlying disease: Hodgkin Disease, non-Hodgkin-lymphoma, multiple myeloma or solid
             tumor

        Exclusion Criteria:

          -  Allogenic stem cell transplantation

          -  Aplastic anemia

          -  Antibiotic treatment within seven days prior to randomization

          -  Signs and symptoms of current infection
Safety and Efficacy of CTAP101 to Treat Secondary Hyperparathyroidism in Stage 3 or 4 CKD and Vitamin D Insufficiency
Condition: Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Vitamin D Deficiency; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: CTAP101 30 μg capsules; Sugar pill to CTAP101 30 μg capsules
Intervention description: CTAP101 30 μg capsule taken daily at bedtime.; Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
Intervention MeSH terms: Calcifediol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 213.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parathyroid Diseases; Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism, Secondary; Vitamin D; Hyperparathyroidism; Kidney Diseases; Kidney Failure; Renal Insufficiency, Chronic

Summary:

      This study will evaluate the efficacy of CTAP101 Capsules versus placebo in reducing intact
      parathyroid hormone (iPTH) by at least 30% from pretreatment baseline; safety and
      tolerability of CTAP101 will also be evaluated
    

Eligibility criteria:

        Inclusion Criteria:

          1. Urinary albumin excretion ≤ 3000 mcg/mg of creatinine

          2. Stage 3 or 4 CKD

          3. Plasma iPTH: ≥ 85 pg/mL and < 500 pg/mL

          4. Serum Ca: ≥ 8.4 mg/dL and < 9.8 mg/dL

          5. Serum P: ≥ 2.0 mg/dL and < 5.0 mg/dL

          6. Serum 25-hydroxyvitamin D: ≥ 10 ng/mL and < 30 ng/mL.

          7. Stable dose of Vitamin D therapy ≤ 1600 IU/day and receiving same dose for at least 2
             months

        Exclusion Criteria:

          1. History of kidney transplant or parathyroidectomy

          2. Spot urine calcium:creatinine ratio > 0.2 (>200 mg/g Cr)

          3. Current serious illness, such as malignancy, HIV, liver disease, cardiovascular event
             or hepatitis

          4. Currently on dialysis

          5. Use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 IU mcg per
             month) during the study
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod
Condition: Relapsing Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Fingolimod; Placebo
Intervention description: Fingolimod 0.5 mg capsules for oral administration once daily; Matching placebo in capsules for oral administration once daily.
Intervention MeSH terms: Fingolimod Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Relapsing remitting multiple sclerosis; multiple sclerosis (MS); safety; tolerability; health outcomes; fingolimod; disease control; MRI

Summary:

      This study evaluated disease control during different lengths of treatment transition from
      natalizumab to fingolimod.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients must:

          -  Have relapsing remitting multiple sclerosis

          -  Have been on treatment with natalizumab for at least 6 months prior to screening and
             discontinuation is an option.

        Exclusion Criteria:

        Patients with:

          -  History of chronic immune disease

          -  Crohn's disease

          -  Certain cancers

          -  Uncontrolled diabetes

          -  Certain eye disorders

          -  Negative for varicella-zoster virus IgG antibodies

          -  Certain hepatic conditions

          -  Low white blood cell count

          -  On certain immunosuppressive medications or heart medications

          -  Resting heart rate less than 45 bpm.

          -  Certain heart conditions or certain lung conditions

          -  Inability to undergo MRI scans

        Other protocol-defined inclusion/exclusion criteria may apply
Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment
Condition: MDD
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Brexpiprazole
Intervention description: Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally
Intervention MeSH terms: Brexpiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No
Keywords: schizophrenia; Major depressive disorder; Anxiety Symptoms; School, Work environment; Mental Disorders; Psychotic Disorders; antipsychotic

Summary:

      To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment
      in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective
      serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI)
      response in a school or work environment.
    

Eligibility criteria:

        Main Inclusion Criteria:

        Have a diagnosis of a single or recurrent, nonpsychotic episode of MDD as defined by the
        Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision
        (DSM-IV-TR) and confirmed by both the Mini International Neuropsychiatric Interview
        (M.I.N.I.) and an adequate clinical psychiatric evaluation.

        Have a treatment history of an inadequate ADT response to at least 1 ADT (but not > 3) for
        the current episode.

        Have received a single, trial-approved, SSRI or SNRI at an adequate dose for ≥ 6 weeks
        prior to screening.

        Are 18 to 35 years old at the time of consent (inclusive, and outpatients only).

        Are (and will be) working 20 hours or more per week or a student taking 6 credit hours or
        more during the trial period, however minor deviations from the "part-time" concept may be
        acceptable on a case-by-case basis based on approval of the medical monitor.

        Have a Hamilton Depression Rating Scale (HAM-D)- 17-item Total Score ≥ 18 at screening and
        baseline.

        Have a Sheehan Disability Scale (SDS) 3-item mean score ≥ 5 at baseline.

        Main Exclusion Criteria:

        Subjects with any of the following current Axis I DSM-IV-TR diagnoses: delirium, dementia,
        amnestic, or other cognitive disorders; schizophrenia, schizoaffective disorder, or other
        psychotic disorders; bipolar I disorder, bipolar II disorder, or bipolar disorder not
        otherwise specified (NOS); eating disorders (including anorexia nervosa or bulimia);
        obsessive compulsive disorder; panic disorder; post-traumatic stress disorder; and
        attention deficit hyperactivity disorder.

        Subjects with any of the following current Axis II DSM-IV-TR diagnoses: borderline,
        antisocial, paranoid, schizoid, schizotypal or histrionic personality disorders, or mental
        retardation.
Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to Therapy
Condition: Chronic Spontaneous Urticaria; Angioedema
MeSH terms: Angioedema; Urticaria; Chronic Urticaria
Intervention: Omalizumab; Placebo
Intervention description: Humanized monoclonal antibody against human IgE; Placebo to omalizumab
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic spontanous urticaria, refractory CSU, Angioedema

Summary:

      This study will assess the impact of omalizumab on the quality of life improvement when added
      to the standard therapy in refractory patients suffering from chronic spontaneous urticaria
      and angioedema.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of chronic spontaneous urticaria (CSU) refractory to H1-antihistamine
             treatment

          -  Presence of itch an hives for more than 6 weeks

          -  UAS7 score of more than 14 (range 0-42)

          -  Patient has history of insufficient response to 4x of the approved dose of
             H1-antihistamines

          -  CSU diagnosis for more than 6 months

          -  Angioedema at least 4x in the last 6 months

        Exclusion Criteria:

          -  Patients with non urticaria associated angioedema

          -  History of hypersensitivity to omalizumab or the rescue medication or to drugs of
             similar chemical structure

          -  Evidence of parasitic infection

          -  Previous treatment with omalizumab within the last 6 months prior to screening

          -  History of anaphylactic shock

          -  Woman who are pregnant or breast feeding

          -  Other protocol-defined inclusion/exclusion criteria may apply.
Open-Label Safety and Tolerability Study of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects.
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Oxymorphone IR
Intervention description: Open-label, 2 part, ascending dose, single and multiple dose q4-6 hrs up to 48 hrs
Intervention MeSH terms: Oxymorphone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Opioid tolerant; Pediatric; Pain; Non malignant; Malignant

Summary:

      When post-operative parenteral analgesia is discontinued, oral dosing with study medication
      may begin once the subject has developed a moderate level of pain as defined by a 100 mm VAS
      (pain intensity score greater than or equal to 40).

      This post marketing study was required by the FDA. Endo Pharmaceuticals Inc. no longer
      promotes opioids and no longer markets Opana® ER.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female > 12 to 17 years of age, inclusive

          -  Weigh at least 50 kg

          -  Postoperative oral opioid analgesia required for at least 24 hours or 48 hours
             following postoperataive parenteral analgesia

          -  Are expected to be hospitalized for the duration of the study

        Exclusion Criteria:

          -  Known allergy to, or a significant reaction to, oxymorphone or another opioid

          -  Life expectancy of < 4 weeks

          -  Positive pregnancy test at screening
Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding
Condition: Metrorrhagia
MeSH terms: Uterine Hemorrhage; Metrorrhagia; Hemorrhage
Intervention: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027); Placebo
Intervention description: 1 pill per day taken orally over 7 cycles of 28 pills per cycle; 1 pill per day taken orally over 7 cycles of 28 pills per cycle
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 231.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dysfunctional uterine bleeding

Summary:

      The purpose of this study is to determine whether the study drug is safe and effective in the
      treatment of dysfunctional uterine bleeding.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women 18 years or older

          -  And with a diagnosis of dysfunctional uterine bleeding without organic pathology

          -  And with at least one of the following symptoms: prolonged, frequent or excessive
             bleeding.

        Exclusion Criteria:

          -  The use of steroidal oral contraceptives, or any drug that could alter oral
             contraception metabolism will be prohibited during the study.

          -  Women with a history of endometrial ablation or dilatation and curettage within 2
             months prior to study start will be excluded.