bioihbjkbjnl/mcl2 huggingface dataset:
Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: Ublituximab; Placebo
Intervention description: Administered as an IV infusion.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: multiple sclerosis

Summary:

      This study evaluates the use of single agent ublituximab, a novel monoclonal antibody, in
      participants with relapsing forms of multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of relapsing multiple sclerosis

          -  Active disease

          -  Greater than or equal to (≥) 2 relapses in prior 2 years or 1 relapse in the year
             prior to screening and/or ≥1 gadolinium (Gd) enhancing lesion

        Exclusion Criteria:

          -  Treatment with anti-cluster of differentiation 20 (CD20) monoclonal antibody within
             the last 12 months

          -  Treatment with alemtuzumab within the last 12 months

          -  Pregnant or nursing mothers
Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
Condition: Choroidal Neovascularization; Age-Related Maculopathy
MeSH terms: Choroidal Neovascularization; Macular Degeneration; Neovascularization, Pathologic
Intervention: dexamethasone; ranibizumab; sham
Intervention description: Intravitreal injection of dexamethasone 700 µg at Day 1.; Ranibizumab 500 µg at day -30 and Day 7-14.; Sham needle-less injection administered in the study eye at Day 1.
Intervention MeSH terms: Dexamethasone; Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 243.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone
      with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients
      with subfoveal choroidal neovascularization secondary to age-related macular degeneration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic
             and/or occult) secondary to AMD

          -  Visual Acuity between 20/40 and 20/400 in the study eye

        Exclusion Criteria:

          -  Any intraocular surgery within 3 months

          -  Glaucoma

          -  Cataract

          -  High eye pressure

          -  Uncontrolled systemic disease
Phase IIb Safety and Efficacy Study of Four Dose Regimens of BAY1021189 in Patients With Heart Failure With Reduced Ejection Fraction Suffering From Worsening Chronic Heart Failure (SOCRATES-REDUCED)
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Vericiguat (BAY1021189) (1.25 mg); Vericiguat (BAY1021189) (5 mg); Placebo
Intervention description: 1.25 mg BAY1021189 tablets; 5 mg BAY1021189 tablets
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 456.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Worsening Heart Failure; Heart Failure with Reduced Ejection Fraction

Summary:

      Objective of the study is to find the optimal dose of the once daily oral soluble guanylate
      cyclase stimulator (sGC) BAY1021189 for Phase III that can be given in addition to standard
      therapy for heart failure with reduced ejection fraction (HFrEF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Worsening chronic heart failure (WCHF) requiring hospitalization (or intravenous
             diuretic treatment for HF without hospitalization) with initiation of study treatment
             after clinical stabilization

          -  Left ventricular ejection fraction (LVEF) <45% by echocardiography at randomization

        Exclusion Criteria:

          -  Intravenous inotropes at any time after hospitalization
Adjuvant Treatment of Pulmonary Embolism With Drotrecogin Alfa (Activated): Phase II Exploratory Study
Condition: Submassive Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Embolism
Intervention: Drotrecogin Alfa (Activated); Enoxaparin; Placebo; Drotrecogin Alfa (Activated); Drotrecogin Alfa (Activated); Drotrecogin Alfa (Activated)
Intervention description: 6 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours; 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target International Normalized Ratio (INR) is reached, minimum of 5 days; intravenous (IV), one infusion, over 12 hours; 12 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours; 18 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours; 24 micrograms/kilograms/hour (ug/kg/hr), intravenous (IV), one infusion, over 12 hours
Intervention MeSH terms: Drotrecogin alfa activated; Enoxaparin; Protein C
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      An exploratory, multicenter, randomized, placebo-controlled, double blind, dose escalation
      study comparing a standard therapy for submassive pulmonary embolism (Enoxaparin sodium) to a
      combined therapy of Drotrecogin alfa (activated) plus Enoxaparin sodium.
    

Eligibility criteria:

        Patients with symptoms of acute pulmonary embolism (PE), without an indication for
        fibrinolytic therapy but with echocardiographic evidence of right ventricular dysfunction
        (submassive PE) within 48 hours of onset of symptoms

        Inclusion Criteria:

          -  Clinical symptoms of Pulmonary embolism for less than 48 hours

        Exclusion Criteria:

          -  Patients with symptoms of Pulmonary embolism for more than 48 hours
STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma
Condition: Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Intervention: vismodegib
Intervention description: 150 mg once daily until disease progression or unacceptable toxicity
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1232.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single-arm, open-label, multi-center study will evaluate the safety and efficacy of
      vismodegib (GDC-0449) in patients with locally advanced or metastatic basal cell carcinoma.
      Patients will receive oral doses of vismodegib 150 mg once daily until disease progression or
      unacceptable toxicity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Metastatic or locally advanced basal cell carcinoma considered inoperable or that
             surgery is contraindicated and radiotherapy is contraindicated or inappropriate

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2

        Exclusion Criteria:

          -  Concurrent anti-tumor therapy

          -  Completion of the most recent anti-tumor therapy less than 21 days prior to the
             initiation of treatment

          -  Uncontrolled medical illness
Safety and Tolerability of Patisiran (ALN-TTR02) in Transthyretin (TTR) Amyloidosis
Condition: TTR-mediated Amyloidosis
MeSH terms: Amyloidosis
Intervention: Patisiran
Intervention description: Participants received a single dose of patisiran as an intravenous (IV) infusion on Day 0 and Day 28 (Q4W). Optional cohorts received an alternative dosing regimen (once every 3 weeks [Q3W]: Day 0 and Day 21) and an alternative premedication regimen.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: RNAi therapeutic

Summary:

      This was a multiple dose, dose escalation study designed to determine the safety,
      tolerability, pharmacokinetics and pharmacodynamics of patisiran (ALN-TTR02) in participants
      with transthyretin (TTR) mediated amyloidosis (ATTR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index must be between 17 kg/m^2 and ≤ 33 kg/m^2;

          -  Women of child-bearing potential must have a negative pregnancy test, cannot be breast
             feeding, and must use appropriate contraception;

          -  Males agree to use appropriate contraception;

          -  Diagnosis of TTR amyloidosis;

          -  Adequate blood counts, liver and renal function;

          -  Willing to give written informed consent and are willing to comply with the study
             requirements.

        Exclusion Criteria:

          -  Known human immunodeficiency virus (HIV) positive status or known or suspected
             systemic bacterial, viral, parasitic, or fungal infection;

          -  Received an investigational agent, other than tafamidis or diflunisal, within 30 days
             prior to first dose study drug administration;

          -  Prior liver transplant;

          -  Poor cardiac function;

          -  Considered unfit for the study by the Principal Investigator;

          -  Employee or family member of the sponsor or the clinical study site personnel.
Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex®
Intervention description: 25 mg daily (two 12.5 mg capsules)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Uterine fibroids

Summary:

      ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued
      safety and efficacy of Proellex in women who have previously completed the double-blind
      portion of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.

        Exclusion Criteria:

          -  Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.

          -  Pregnant or breastfeeding.
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
Condition: Infantile Colic
MeSH terms: Colic
Intervention: Nepadutant oral solution; Nepadutant oral solution; Placebo matching Nepadutant oral solution
Intervention description: Oral administration once daily for 7 days; Oral administration once daily for 7 days; Oral administration once daily for 7 days
Intervention MeSH terms: Pharmaceutical Solutions; MEN 11420
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 115.0
Sex: All
Minimum age: 4 Weeks
Maximum age: 20 Weeks
Healthy volunteers: No
Keywords: Infantile Colic; tachykinin antagonist; Nepadutant

Summary:

      This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind,
      placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and
      safety of Nepadutant given at two oral doses once daily for seven days in comparison to
      placebo in the treatment of infantile colic.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy infants with diagnosis of infant colic according to the following modified
             Wessel criterion "paroxysm of irritability, fussing or crying that start and stop
             without obvious cause for >3h/day, >3 days/week for one week"

          -  Age > 4 weeks and < 20 weeks

          -  Infants breast-fed mixed fed or formula fed with a stable dietary regimen

          -  Normal growth

          -  History of no adequate response to conventional treatment alternatives which make the
             infants in need of medical treatment

          -  Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or
             antiacids during the study period.

        Exclusion Criteria:

          -  Clinical evidence of allergies or other diseases which may cause crying and/or
             fussiness or may interfere with absorption or clearance of the drug.

          -  Suspect of gastroesophageal reflux disease (GERD)

          -  Suspect of cow milk allergy.
A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Condition: Haemostasis; Haemophilia A
MeSH terms: Hemophilia A
Intervention: Concizumab; Turoctocog alfa
Intervention description: 0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase; Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under
      the skin) once daily in preventing bleeding episodes in patients with severe haemophilia A
      without inhibitors.
    

Eligibility criteria:

        Inclusion Criteria: - Informed consent obtained before any trial-related activities.
        Trial-related activities are any procedures that are carried out as part of the trial,
        including activities to determine the suitability for the trial - Male patients aged 18
        years or older at the time of signing informed consent, diagnosed with severe haemophilia A
        (FVIII activity below 1%), based on medical records or results at screening Exclusion
        Criteria: - Known or suspected hypersensitivity to trial product(s) or related products -
        Known inherited or acquired bleeding disorder other than haemophilia A - Presence of
        inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units)
        at screening measured by the Nijmegen method
A Study Evaluating the Safety, Tolerability, and Effect on Microvascular Obstruction of Intravenous Temanogrel in Adult Participants Undergoing Percutaneous Coronary Intervention
Condition: Microvascular Obstruction
Intervention: Temanogrel; Placebo
Intervention description: Participants will receive a single intravenous dose of temanogrel on Day 1 (Day 1 of PCI procedure); Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
Intervention MeSH terms: APD791
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Temanogrel; Microvascular obstruction; APD791; Percutaneous coronary intervention; MVO; PCI

Summary:

      The purpose of this study is to determine whether intravenous temanogrel is a safe and
      effective treatment for microvascular obstruction (MVO) in adult participants undergoing
      percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable angina participants suitable for elective PCI, or participants suitable for PCI
             for diagnosis of non-ST-elevation myocardial infarction or unstable angina (NSTEMI/UA)
             who are consistently hemodynamically stable until the time of PCI and have a
             thrombolysis in myocardial infarction (TIMI) Flow Grade 2 or 3 on the diagnostic
             angiography

          -  Target lesions for PCI must appear suitable for stenting as confirmed on the
             diagnostic angiography and must satisfy the study criteria regarding lesion size and
             vessel diameter/type.

          -  Females must not be of childbearing potential

          -  Males with pregnant or non-pregnant female partners of childbearing potential must
             agree to using a condom during treatment and for 90 days following treatment

        Exclusion Criteria:

          -  Planned or anticipated use of rotational atherectomy/ablation or shockwave therapies
             during the PCI procedure

          -  Any history of stroke, seizure, intracranial bleeding, or intracranial aneurysm

          -  Transient ischemic attack within the 6 months prior to Screening

          -  History of major trauma, major surgery, and/or clinically significant head injury or
             hemorrhage within the last 6 months of Screening

          -  Any ST-elevation myocardial infarction (STEMI) within 10 days of Screening or STEMI
             within the target vessel territory within the last 4 months of Screening
Adjuvant Chemotherapy for High Risk Uterine Leiomyosarcoma
Condition: Leiomyosarcoma; Uterine Neoplasm
MeSH terms: Leiomyosarcoma; Uterine Neoplasms
Intervention: gemcitabine, docetaxel, doxorubicin
Intervention description: Cycles = 28 days
Intervention MeSH terms: Gemcitabine; Docetaxel; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: early stage; high grade; uterine leiomyosarcoma; adjuvant treatment

Summary:

      The purpose of this trial is to study the benefits of giving chemotherapy to women after they
      have had surgical resection of their primary disease and have no evidence of disease
      remaining(known as adjuvant therapy). The major objective of this study is to determine the
      progression free survival. The goal is to prevent relapse or recurrence of their uterine
      leiomyosarcoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years of age

          -  high risk uterine LMS, FIGO stage I or II

          -  pathology review of LMS high grade and /or mitotic rate greater than or equal to 5
             mitoses/10 hpf

          -  no longer than 12 weeks from surgical resection of cancer

          -  no evidence of residual disease

          -  ECOG 0 or 1

          -  ANC ≥ 1,500, hemoglobin ≥ 8.0, platelets ≥100,000

          -  creatinine ≤ 1.5 x institutional upper limits of normal

          -  adequate liver function

          -  neuropathy (sensory and motor) ≤ CTC grade 1

          -  negative pregnancy test

          -  signed consent

        Exclusion Criteria:

          -  patients with other invasive malignancies

          -  prior therapy with gemcitabine or docetaxel or doxorubicin

          -  hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

          -  women who are breast feeding

          -  cardiac ejection fraction <50%

          -  prior pelvic irradiation

          -  treatment with hormone replacement or anti-hormonal agents or other cytotoxic agents
Hydromorphone and C-section
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Hydromorphone
Intervention description: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
Intervention MeSH terms: Hydromorphone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 20.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will investigate the dose of hydromorphone which will relieve the pain of women
      following a cesarean section when delivered directly in the area around the spinal cord
      (i.e., intrathecal injection). The primary objective is to determine the dose of intrathecal
      hydromorphone that results in a pain score of less than 3 out of 10 12 hours after
      intrathecal injection in 50% of women. Secondary objectives include determining the average
      amount of time patients obtain pain relief after injection. Other secondary objectives
      include determining the frequency and severity of side-effects associated with intrathecal
      administration of hydromorphone, including: bradycardia, hypotension, respiratory depression,
      apnea, pruritus, rash, nausea, vomiting, and drowsiness. Thirty women admitted to labor and
      delivery for planned cesarean section desiring will be consented for the study. The starting
      dose of intrathecal hydromorphone will be 6 mcg. The up-and-down sequential allocation method
      of statistical analysis will be used, meaning that each subsequent dose will be dependent
      upon the result obtained from the prior dose - ergo, if the initial subject has pain relief,
      the second subject will receive 4 mcg (2 mcg less), but if the initial subject does not have
      pain relief, the second subject will receive 8 mcg (2 mcg more) of hydromorphone.

      After the intrathecal injection is given, patients will undergo their cesarean section. The
      patient's pain will be assessed at 6, 12, and 18 hours post-injection using a questionnaire.
      The patient's medical record will be reviewed to determine when she first requested
      supplemental pain medication. A pain score of less than three will be a positive result. A
      pain score of three or greater will be a negative result. Blood pressure, heart rate,
      arterial oxygen saturation, 5 and 10 minute APGAR scores, and any side effects will also be
      assessed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women undergoing cesarean section

        Exclusion Criteria:

          -  Any comorbidities other than obesity, hypertension, fetal anomalies