bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload
Condition: Iron Overload Due to Repeated Red Blood Cell Transfusions
MeSH terms: Iron Overload
Intervention: Deferiprone DR tablets 1000 mg (Low dosage); Deferiprone DR tablets 1000 mg (High dosage)
Intervention description: Deferiprone DR tablets 1000 mg; Deferiprone DR tablets 1000 mg
Intervention MeSH terms: Deferiprone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iron overload; chelation; deferiprone; Ferriprox

Summary:

      Safety, tolerability, and acceptability of twice-daily dosing with deferiprone
      delayed-release (DR) tablets in patients with systemic iron overload.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female aged ≥ 18 years.

          2. Diagnosis of thalassemia syndrome, sickle cell disease, or other disorder requiring a
             regular regimen of red blood cell transfusions.

          3. On a stable regimen (≥3 months) of Ferriprox tablets for the treatment of systemic
             iron overload.

          4. Absolute neutrophil count ≥1.5 x 10^9/L at screening.

          5. A record of at least 12 measured alanine aminotransferase (ALT) and aspartate
             aminotransferase (AST) levels.

        Exclusion Criteria:

          1. Receipt of any iron chelator other than Ferriprox (i.e., combination therapy) in the
             last 3 months, or planning to receive it at any time during the period of the study.

          2. ALT and/or AST value > 5 times the upper limit of normal (ULN) at screening

          3. Active case of hepatitis B or C at screening.
Study to Evaluate Effect of a Single Dose of Sotatercept (ACE-011) on Red Blood Cell Mass and Plasma Volume in Participants With Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Intervention: Sotatercept
Intervention description: single 35 mg SC dose of sotatercept on study Day 1, Day 43, and Day 85
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Red Blood Cell Mass; Plasma Volume; Solid Tumors

Summary:

      What hematopoietic precursor compartments as well as hemoglobin subtypes are affected by
      dosing with sotatercept (ACE-011)? Based upon a similar prior study with Procrit, Celgene has
      determined that all of these goals could be obtained by an intense 10-patient sotatercept
      (ACE-011) pharmacodynamic study, completed by two well-known experts in the red cell
      production field.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥18 years of age.

          -  Histologically confirmed diagnosis of a solid tumor malignancy documented by cytology
             or biopsy.

          -  Presence of metastatic disease.

          -  Hemoglobin value between ≥8.0 to <11.0 g/dL (≥80 to <110 g/L).

          -  ≥28 days must have elapsed (prior to pre-dose red blood cell mass / plasma volume
             test) since previous treatment with erythropoiesis-stimulating agent (including
             concurrent treatment with intravenous [IV] iron).

          -  ≥28 days must have elapsed (prior to Day 1) since the last red blood cell transfusion
             and receipt of ≤2 units of blood in the past 56 days (prior to Day 1).

          -  Eastern Cooperative Oncology Group (ECOG) Performance status of 0 - 1.

        Exclusion Criteria:

        At the time of screening, participants who have any grade ≥3 toxicity (according to the
        currently active minor version of NCI CTCAE v4.0) except for the following disease-related
        toxicities:

          -  Hematological events - anemia, thrombocytopenia, neutropenia

          -  Non-hematological events - nausea, vomiting, fatigue, muscle or bone/joint pain
Study With Subjects 18-65 Years Old With Partial Onset Seizures Who Are Currently Taking Levetiracetam
Condition: Epilepsy, Partial
MeSH terms: Epilepsy; Seizures; Epilepsies, Partial
Intervention: Seletracetam (UCB44212)
Intervention description: Pharmaceutical form: oral capsules
Concentration: 2, 10 and 50 mg
Route of administration: oral administration
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Epilepsy; Partial Onset Seizures; Seletracetam; Levetiracetam

Summary:

      This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects
      with focal epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males/Females from 18 to 65 years of age (minimum body weight of 40 kg)

          -  Subjects with a confirmed diagnosis of epilepsy suffering from partial onset seizures
             whether or not secondarily generalized

          -  Subjects who have been treated for epilepsy for >= 6 months and are currently
             uncontrolled while being treated with 1-3 concomitant AED(s), inclusive of
             levetiracetam (LEV)

          -  Female subjects without childbearing potential or those who are using an acceptable
             contraceptive method

        Exclusion Criteria:

          -  Seizures occurring in clusters. Status epilepticus within 6 months of Visit 1. History
             of non-epileptic seizures

          -  Subjects on vigabatrin

          -  Subjects on felbamate, unless treatment has been continuous for >2 years

          -  Ongoing psychiatric disease other than mild controlled disorders

          -  Subjects with clinically significant organ dysfunction

          -  Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients

          -  Pregnant or lactating women

          -  Use of benzodiazepines (for any indication) taken at a higher frequency than an
             average of once a week, unless counted as one of the concomitant Antiepileptic Drug
             (AEDs).
Amantadine to Speed Awakening After Cardiac Arrest
Condition: Coma; Heart Arrest; Anoxia
MeSH terms: Heart Arrest
Intervention: Amantadine; Placebo
Intervention description: 100mg twice per day for 7 days at 0600 and 1200; Placebo comparator
Intervention MeSH terms: Amantadine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: heart arrest; resuscitation; seizures; hypothermia, induced; Amantadine

Summary:

      This study evaluates if amantadine will increase the rate of awakening in patients
      resuscitated from cardiac arrest but comatose (not following commands) after their
      resuscitation. Half of the participants will receive amantadine and the other will receive
      placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Non traumatic cardiac arrest

          -  Age 18 and older

          -  Defibrillation and/or chest compressions by healthcare providers

          -  Return of spontaneous circulation

        Exclusion Criteria:

          -  Written do not attempt resuscitation (DNAR) reported to providers before randomization

          -  Known prisoner or pregnancy

          -  Lack of motor response to pain and absent N20 response on somatosensory evoked
             potentials prior to randomization

          -  Initial CT demonstrating brain edema (defined as grey white ratio <1.2)

          -  Presence of malignant pattern on EEG at time of randomization

          -  Next of kin unwilling to provide supportive care for at least one week after
             enrollment

          -  Presently using other dopaminergic agent
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Bexsero; Saline Placebo; Havrix; MenABCWY
Intervention description: Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB_0_2 Group.; One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY_ 0_2 Group and rMenB_0_2 Group, Month 2 in ABCWY_0_6 Group and ABCWY_0_11 Group and Month 6 in ABCWY_0_1 Group.; Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY_0_1 Group, Month 1 and 12 in Group ABCWY_0_6 Group and ABCWY_0_2_6 Group , Month 0 and 6 in ABCWY_0_11 Group and Month 6 and 12 in ABCWY_ 0_2 Group and rMenB_0_2 Group.; Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY_0_1 Group, Month 0 and 6 in ABCWY_0_6 Group, Month 1 and 12 in ABCWY_0_11 Group, Month 0, 2 and 6 in ABCWY_0_2_6 Group, Month 0 and 2 in ABCWY_ 0_2 Group and rMenB_0_2 Group.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1063.0
Sex: All
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purposes for conducting the study are firstly to assess immunological
      non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to
      healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine
      (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give
      the flexibility for the national vaccination program by showing the safety and immunogenicity
      of MenABCWY administrated according to four different vaccination schedules and additionally
      to evaluate a potential benefit of the 3-dose vaccination series.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adolecents from 10-18 yearsof age, generally in good health, and available for all
             study visits, and who/whose legally acceptable representative has given written
             informed consent at the time of enrollment.

          2. Individuals of who the investigator believes can and will comply with the requirements
             of the protocol (e.g. use of an eDiary, return for follow-up visits, available for
             phone contacts).

          3. Female subjects of childbearing potential must have a negative urine preganancy test.

        Exclusion Criteria:

          1. Serious, acute, or chronic illness. Previous or suspected disease caused by N.
             meningitidis. Previous immunization with any menincococcal or Hepatitis A vaccines.

          2. Exposure to individuals with clicically proven meningococcal disease or clinical
             bacterial meningitis without further microbiologic characteriszation.
Evaluation of DEX-IN During Outpatient Procedures
Condition: Pain
Intervention: DEX-IN; Fentanyl; Placebo
Intervention description: IN Dexmedetomidine + IV placebo; IN Placebo + IV Fentanyl; IN Placebo + IV Placebo
Intervention MeSH terms: Fentanyl
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blind, double-dummy
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Peri-procedural pain; Pain; Anxiety; Analgesia; Anxiolysis

Summary:

      The primary objective of this study is to evaluate the analgesic efficacy of DEX-IN compared
      with placebo and active control (fentanyl), in subjects undergoing painful outpatient and
      office based procedures.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntarily provide written informed consent

          -  Be planned to undergo a selected office-based or outpatient procedure

          -  Be naïve to the planned procedure, i.e. no repeated or revision procedures

          -  Not pregnant or planning to become pregnant, or using appropriate contraceptive
             measures.

        Exclusion Criteria:

          -  Known allergy to any study treatment or excipient

          -  Have another painful physical condition or anxiety related diagnosis that may confound
             study assessments

          -  Evidence of a clinically significant finding on physical examination, laboratory
             assessment, or ECG

          -  Have signs or a history of significant nasal condition that may interfere with
             intranasal drug delivery
Citrulline in Severe Sepsis
Condition: Severe Sepsis; Acute Lung Injury
MeSH terms: Sepsis; Toxemia; Lung Injury; Acute Lung Injury
Intervention: High Dose Citrulline; Placebo; Low Dose Citrulline
Intervention description: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days; D5W IV fluids at isovolumetric rate (about 15ml/hr); Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 13 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo-controlled, phase 2 study to evaluate
      biochemical, clinical, and safety effects of 2 doses of intravenous L-citrulline compared to
      placebo in patients with severe sepsis at risk for or with acute lung injury. The hypothesis
      is that intravenous L-citrulline will decreased the development or progression of acute lung
      injury in patients with severe sepsis compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Severe Sepsis

        Exclusion Criteria:

          -  No Consent

          -  Malignant or other irreversible condition

          -  Moribund and not expected to survive 48 hours

          -  End Stage Liver Disease

          -  Enrolled in another IND study

          -  Pregnant or breast feeding female

          -  Age<13 years old

          -  Allergy to citrulline or arginine
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
Condition: Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Placebo; Cariprazine
Intervention description: Placebo was supplied in capsules.; Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 584.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar I disorder; Bipolar depression; Depression; Bipolar disorder

Summary:

      The objective of this study was to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of participants with bipolar depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have provided informed consent prior to any study specific
             procedures.

          -  Participants currently meeting the Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder
             as confirmed by the Structured Clinical Interview (SCID) with a current with a current
             major depressive episode of at least 4 weeks and not exceeding 12 months in duration.

          -  Participants with normal physical examination, laboratory, vital signs, and/or
             echocardiogram (ECG).

          -  Verified previous manic or mixed episode.

          -  Participants with a total Hamilton Rating Scale for Depression (HAMD)-17 score ≥ 20.

          -  Participants with a HAMD-17 item 1 score ≥ 2.

          -  Participants with a Clinical Global Impression of Severity (CGI-S) score ≥ 4.

        Exclusion Criteria:

          -  Participants with a DSM-IV-TR diagnosis of an axis I disorder other than bipolar I
             disorder that was the primary focus of treatment within the previous 6 months.

          -  Women who are pregnant or breast feeding

          -  Participants with Young Mania Rating Scale (YMRS) total score > 10

          -  Participants who have dementia, mental retardation, schizophrenia/schizoaffective
             disorder.
A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Telapristone Acetate; Placebo
Intervention description: Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.; Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43.0
Sex: Female
Minimum age: 18 Years
Maximum age: 47 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to determine the safety and efficacy of two oral doses
      of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by
      an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Is a pre-menopausal female, between 18 and 47 years

          -  Participant has a history of at least 3 regular menstrual cycles in which menorrhagia
             (heavy bleeding) is due to uterine fibroids

          -  Confirmed uterine fibroid(s) at screening

          -  Visit 1 historical pictorial blood loss assessment chart of >120 milliliters (mL) of
             blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by
             Alkaline Hematin Assay (during the baseline assessment period).

          -  A Body Mass Index (BMI) between 18 and 45 inclusive

        Exclusion Criteria:

          -  Participant is pregnant or lactating or is attempting or expecting to become pregnant
             during the entire study period

          -  Received an investigational drug in the 30 days prior to the screening for this study

          -  Has an intrauterine device in place

          -  Observation or history of abnormal endometrial biopsy including the presence of
             endometrial intraepithelial neoplasia

          -  Participants with abnormally high liver enzymes or liver disease
Study to Assess the Efficacy, Safety and Tolerability of AKB-9778 Ophthalmic Solution as and Adjunct to Latanoprost in Patients With Ocular Hypertension or Open Angle Glaucoma
Condition: Ocular Hypertension; Primary Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Latanoprost ophthalmic solution; AKB-9778 4%; Placebo
Intervention description: Latanoprost opthalmic solution to be dosed once daily; Razuprotafib opthalmic solution; placebo for razuprotafib opthalmic solution
Intervention MeSH terms: Ophthalmic Solutions; Latanoprost
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 194.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase 2, double masked, randomized, multi-center, parallel-group, 28-day study
      assessing the safety, tolerability and ocular hypotensive efficacy of AKB-9778 Ophthalmic
      Solution 4.0% administered once (AM) or twice (AM & PM) daily when used as an adjunctive
      therapy to latanoprost ophthalmic solution 0.005% once daily (PM) in subjects with elevated
      IOP due to OAG or OHT.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of OAG or OHT in each eye (OAG in one eye and OHT in the fellow eye is
             acceptable)

          -  Must be receiving treatment with a stable regimen of topical prostaglandin eyedrop for
             a minimum of 2 weeks prior to the Screening Visit; may be taking one additional IOP
             lowering eyedrop

          -  IOP of ≥ 18 mmHg and ≤ 27 mmHg in one eye or both eyes at Screening visit

          -  Following 4 week washout period, IOP ≥ 24 mmHg and < 36 mmHg at 08:00 hour and IOP ≥
             22 mmHg and < 36 mmHg in both eyes at 10:00, 12:00 and 16:00 hours.

        Key Exclusion Criteria:

          -  Clinically significant ocular disease which might interfere with interpretation of the
             study efficacy endpoints or with safety assessments

          -  Pseudoexfoliation or pigment dispersion component glaucoma

          -  History of angle closure glaucoma, or narrow angles or with evidence of peripheral
             anterior synechiae (PAS) ≥ 180 degrees by gonioscopy within 6 months prior to
             Screening

          -  Intraocular pressure ≥ 36 mmHg

          -  Cup/disc ratio of > 0.8 in either eye

          -  Severe visual field defect or significant defect (sensitivity of ≤ 10dB) within 10
             degrees of fixation in either eye