ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01096784
Conditions: Retinopathy of Prematurity (ROP)
Keywords: insulin-like growth factor ROP IGF-I BPD bronchopulmonary dysplasia retinopathy of prematurity
Sponsor: Shire
Start date: 2010-06-18; Completion date: 2016-03-30
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.

Detailed description:
When preterm infants are deprived of their natural intrauterine environment they lose access to important factors, normally found in utero, such as proteins, growth factors, and cytokines. It has been demonstrated that insulin-like growth factor-1 (IGF-1) is one such factor. In utero these biological factors are introduced to the fetus via placental absorption or ingestion from amniotic fluid. Deprivation of such factors is likely to cause inhibition or improper stimulation of important pathways, which in the case of the eye may cause abnormal retinal vascular growth, the hallmark of retinopathy of prematurity (ROP).

Retinopathy of prematurity is the major cause of blindness in children in the developed and developing world, despite the availability of current treatment of late-stage ROP. As developing countries provide more neonatal and maternal intensive care, which increases the survival of preterm born infants, the incidence of ROP is increasing.

This phase 2 study was originally designed in 3 sections, Sections A, B, and C which are now complete. The protocol was amended and patients enrolled from this point forward will be enrolled into Section D.

In Study Section D, a total of 120 subjects (GA of 23 weeks + 0 days to 27 weeks + 6 days) will be randomly assigned with 1:1 allocation ratio to either treatment with rhIGF-1/rhIGFBP-3 or to receive standard neonatal care (Control Group) to obtain at least 80 evaluable subjects. Duration of infusion will last at longest from Study Day 0 (day of birth) up to and including PMA 29 weeks + 6 days, when the subject's endogenous production of IGF-1 is considered sufficient to maintain physiologic serum IGF-1 levels. After discontinuation of study drug infusion, each subject will be followed to PMA 40 weeks ± 4 days.

Arms: arm 1: Continuous IV Infusion arm 2: The comparator group will receive no treatment with rhIGF-1/rhIGFBP-3
Interventions: intervention 1: rhIGF-I/rhIGFBP-3
Intervention descriptions: intervention 1: Continuous intravenous infusion

Protocol documents:
Clinical trial NCT02487108
Conditions: Pain
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2015-08-11; Completion date: 2016-03-30
Enrollment: 569 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating participants with moderate to severe pain following bunionectomy.

Detailed description:

Arms: arm 1: Participants will receive placebo matching to TV46763 (hydrocodone bitartrate/acetaminophen) immediate release (IR) tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period. arm 2: Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 5.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period. arm 3: Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 7.5 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period. arm 4: Participants will receive TV46763 (hydrocodone bitartrate/acetaminophen) 10.0 mg/325 mg IR tablets for 48 hours (every 4 to 6 hours) on Days 1, 2, and 3 during the inpatient treatment period. Participants will continue to take the same treatment daily, every 4 to 6 hours after discharge on Day 3, over a 10-day (±1 day) outpatient treatment period.
Interventions: intervention 1: TV-46763 intervention 2: Placebo
Intervention descriptions: intervention 1: TV-46763 will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to TV-46763 will be administered per schedule specified in the arm description.

Protocol documents:
Clinical trial NCT01414205
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Genentech, Inc.
Start date: 2011-10-31; Completion date: 2016-03-31
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \[IV\] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.

Detailed description:

Arms: arm 1: Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose. arm 2: Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
Interventions: intervention 1: Obinutuzumab intervention 2: Corticosteroids
Intervention descriptions: intervention 1: Participants were administered obinutuzumab either at 1000 mg or 2000 mg on Day 1, 8, 15 of Cycle 1 and then on Day 1 of each 21 day cycles for up to 8 cycles. intervention 2: Participants were administered corticosteroids IV prior to the initial dose.

Protocol documents:
Clinical trial NCT01514370
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Interferon beta 1a Curcumin
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2012-04-30; Completion date: 2016-03-31
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, monocentric, double blind, placebo controlled, two arm study.

Curcumin is derived from the rhizomes of the plant Curcuma longa (common name, turmeric) belonging to the Zingiberaceae family found in South Asian countries, especially India which is the largest producer. BCM95 (bioCurcumin) is a combination of a Curcumin extract and oil to enhance the bio-absorbability in humans. BCM95 may enhance and prolong the antioxidant and anti-inflammatory effects of the standard therapy maintaining a good safety profile.

Detailed description:
The subjects must experience at least one Gadolinium (GD) enhancing Magnetic Resonance Imaging (MRI) lesion at the baseline visit or one Multiple Sclerosis (MS) relapse in the last 6 months before the screening visit.

Randomization, in a 1:1 ratio, will be done with two arms:

40 subjects with Interferon (IFN) beta 1 a 44 mcg TIW + Curcumin (BCM 95) and 40 subjects with IFN beta-1a 44 mcg TIW + placebo.

The study will last 42 months: 18 months of enrolment and 24 months of treatment period.

The study consists of 6 visits per subject: screening visit (Visit 0), baseline (Visit 1), a visit 3 months after baseline (Visit 2), 6 months after baseline (Visit 3), 12 months after baseline (Visit 4) and 24 months after baseline (Visit 5).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: IFN beta 1a 44 mcg TIW intervention 2: Curcumin intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months. intervention 2: Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months. intervention 3: Subjects received placebo matched to curcumin orally twice a day for 24 months.

Protocol documents:
Clinical trial NCT01922037
Conditions: Asthma
Sponsor: Hoffmann-La Roche
Start date: 2013-06-19; Completion date: 2016-03-31
Enrollment: 806 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multicenter, prospective study will evaluate the baseline participant characteristics (including biomarkers) associated with a variety of individual and composite clinical outcomes in participants with moderate to severe asthma initiating treatment with omalizumab.

Detailed description:

Arms: arm 1: Participants with allergic asthma, who have decided to initiate treatment with omalizumab will be observed until a maximum follow-up of 12 months, death, withdrawal of consent, loss to follow-up, or study closure, whichever occurs first.
Interventions: intervention 1: Omalizumab
Intervention descriptions: intervention 1: Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.

Protocol documents:
Clinical trial NCT02231580
Conditions: Huntington's Disease
Keywords: Neurodegenerative genetic disorder
Sponsor: Ipsen
Start date: 2014-09-01; Completion date: 2016-03-31
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of BN82451B versus placebo after oral administration twice daily (bid) for 28 days in patients with Huntington's Disease (HD).

Detailed description:

Arms: arm 1: BN82451B capsule: Up to 3 dose levels (40, 60 or 80 mg) twice daily administered orally. arm 2: Placebo capsule: Up to 3 dose levels (40, 60 or 80 mg) twice daily administered orally.
Interventions: intervention 1: BN82451B intervention 2: Placebo
Intervention descriptions: intervention 1: BN82451B capsule intervention 2: Placebo capsule

Protocol documents:
Clinical trial NCT02407756
Conditions: Atopic Dermatitis
Keywords: Eczema
Sponsor: Regeneron Pharmaceuticals
Start date: 2015-03-31; Completion date: 2016-03-31
Enrollment: 78 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).

The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to \<18 years of age) or severe AD (for children ≥6 to \<12 years of age).

Detailed description:

Arms: arm 1: Cohort 1 will receive dupilumab dosing regimen 1 arm 2: Cohort 2 will receive dupilumab dosing regimen 2
Interventions: intervention 1: Dupilumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02663128
Conditions: Healthy
Sponsor: AstraZeneca
Start date: 2016-01-31; Completion date: 2016-03-31
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to measure how much of a new tablet formulation of lanabecestat gets into the blood stream and how long it takes the body to get rid of it, compared to the current tablet formulation of lanabecestat. The effect of a high fat meal on how quickly the body absorbs the new tablet formulation will also be evaluated. In addition any side effects of the study drug using both the new and current tablet formulations will be evaluated. The study will last about 22 days, with screening required within 30 days prior to the start of the study.

Detailed description:

Arms: arm 1: Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. arm 2: Lanabecestat: 50 mg administered once PO in each of 3 treatment periods. arm 3: Lanabecestat: 50 mg administered once PO in each of 3 treatment periods.
Interventions: intervention 1: Lanabecestat
Intervention descriptions: intervention 1: Administered orally

Protocol documents:
Clinical trial NCT03021642
Conditions: Healthy
Keywords: Healthy volunteer Tepotinib Mesenchymal-epithelial transition factor Translocated promoter region
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2016-01-31; Completion date: 2016-03-31
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase I, open label, randomized, crossover trial to investigate the relative bioavailability of tepotinib in healthy volunteers. Twenty-four volunteers will be randomized to one of the two treatment sequences: Sequence A: test, reference, Sequence B: reference, test. The reference treatment refers to the current Phase II film-coated tablet (5 \* 100 milligram (mg) tepotinib film-coated tablets) and the test treatment to the new Phase III film-coated tablet (1 \* 500 mg film-coated tepotinib tablet).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tepotinib test (Treatment Period 1) intervention 2: Tepotinib reference (Treatment Period 2) intervention 3: Tepotinib reference (Treatment Period 1) intervention 4: Tepotinib test (Treatment Period 2)
Intervention descriptions: intervention 1: Subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 1 (Day 1) intervention 2: Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 2 (Day 22) intervention 3: Subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 \* 100 mg tablet) in Treatment period 1 (Day 1) intervention 4: Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 \* 500 mg tablet) in Treatment period 2 (Day 22)

Protocol documents:
Clinical trial NCT01567527
Conditions: Bipolar I Disorder
Keywords: Aripiprazole Intramuscular (IM) Depot Bipolar
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2012-08-01; Completion date: 2016-04-01
Enrollment: 731 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This will be a randomized, double-blind, placebo-controlled trial to assess the time to recurrence of any mood episode in subjects with bipolar I disorder who have maintained stability on aripiprazole IM depot for at least 8 weeks. This trial will include male and female subjects 18 to 65 years of age, inclusive, with a diagnosis of bipolar I disorder, according to DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI), who have experienced at least one previous manic episode of sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic agent in addition to their current manic episode. All subjects must be experiencing a manic episode (per DSM-IV-TR criteria) with a YMRS total score ≥ 20 at trial entry. Both inpatients and outpatients are eligible for this trial.

This trial will consist of a screening phase followed by 4 treatment phases. Subjects will undergo screening for eligibility, followed by a conversion to oral aripiprazole monotherapy phase, if needed, an oral aripiprazole stabilization phase, a single-blind aripiprazole IM depot stabilization phase, and, a double-blind, placebo-controlled phase.

Detailed description:

Arms: arm 1: Active Comparator: Treatment of Aripiprazole IM Depot arm 2: Placebo Comparator: Treatment of IM Depot Placebo
Interventions: intervention 1: Intramuscular (IM) Depot Aripiprazole intervention 2: Intramuscular (IM) Depot Placebo
Intervention descriptions: intervention 1: Formulation: Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection intervention 2: Formulation: Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection

Protocol documents:
Clinical trial NCT02055781
Conditions: Primary Myelofibrosis Post-polycythemia Vera Myelofibrosis Post-essential Thrombocythemia Myelofibrosis
Keywords: Myelofibrosis Post-Polycythemia Vera Myelofibrosis Post-Essential Thrombocythemia Myelofibrosis Primary Myelofibrosis Polycythemia Vera Essential Thrombocythemia Bone Marrow Disease Hematologic Diseases Hemorrhagic Disorders Splenomegaly Pacritinib MPN-SAF MPN-SAF TSS Anemia Myeloproliferative Neoplasm Spleen volume Thrombocytopenia SB1518
Sponsor: CTI BioPharma
Start date: 2014-02-01; Completion date: 2016-04-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.

Detailed description:
Multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of BAT in patients with thrombocytopenia and primary or secondary myelofibrosis. Approximately 300 eligible patients will be randomized in a 1:1:1 allocation to pacritinib 400 mg dosed QD, pacritinib 200 mg dosed BID, or BAT (includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry). Spleen volume will be measured by MRI or CT at baseline and every 12 weeks thereafter. An independent radiology facility (IRF), blind to treatment assignments, will measure spleen volumes. Patients will also be followed for safety, Leukemia Free Survival (LFS), Overall Survival (OS), frequency of red blood cell (RBC) and platelet transfusions, and other exploratory endpoints. An Independent Data Monitoring Committee (IDMC) will evaluate the safety of pacritinib.

Arms: arm 1: Pacritinib 400 mg QD arm 2: Pacritinib 200 mg BID arm 3: BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry.
Interventions: intervention 1: Pacritinib intervention 2: Best Available Therapy
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00006244
Conditions: Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: Fred Hutchinson Cancer Center
Start date: 2000-02-01; Completion date: 2016-04-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies the effectiveness of melphalan, peripheral stem cell transplantation, and interleukin-2 followed by interferon alfa in treating patients who have advanced multiple myeloma (MM). Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Interleukin-2 (IL2) may stimulate a person's white blood cells to kill multiple myeloma cells. Interferon alfa may interfere with the growth of cancer cells

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate initial response to therapy, time to disease progression, and overall survival in MM patients treated with melphalan, IL2- incubated peripheral blood stem cells, and sequential IL2.

SECONDARY OBJECTIVES:

I. Evaluate grade 3-4 toxicities encountered by younger (\< 56 years old) and older (\>56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

OUTLINE:

Patients receive melphalan intravenously (IV) over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa subcutaneously (SC) 3 times a week in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: melphalan intervention 2: recombinant interferon alfa intervention 3: aldesleukin intervention 4: in vitro-treated peripheral blood stem cell transplantation
Intervention descriptions: intervention 1: Given IV intervention 2: Given SC intervention 3: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion intervention 4: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion

Protocol documents:
Clinical trial NCT00454805
Conditions: Advanced Breast Cancer
Keywords: Advanced Breast Cancer
Sponsor: AstraZeneca
Start date: 2007-03-01; Completion date: 2016-04-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.

Detailed description:

Arms: arm 1: Fulvestrant Monotherapy arm 2: AZD2171 + Fulvestrant
Interventions: intervention 1: AZD2171 intervention 2: Fulvestrant
Intervention descriptions: intervention 1: Oral tablet intervention 2: intramuscular injection

Protocol documents: