ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01924845
Conditions: Late-onset Pompe Disease
Sponsor: BioMarin Pharmaceutical
Start date: 2014-04-01; Completion date: 2016-09-12
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study 701-301 is a single-arm, open-label, switchover study in patients with late-onset Pompe disease who have been receiving treatment with recombinant human acid alpha-glucosidase (rhGAA) for 48 weeks or longer. Ambulatory patients who have mild to moderate respiratory impairment will switch directly to receive BMN 701 20 mg/kg by IV infusion every other week. All participants will receive active drug. No dose of existing therapy will be missed - experimental drug is started immediately.

Detailed description:

Arms: arm 1: BMN 701 IV Infusion 20mg/kg every 2 weeks for 24 weeks followed by an optional extension of 240 weeks (total duration of therapy 264 weeks)
Interventions: intervention 1: BMN 701
Intervention descriptions: intervention 1: BMN 701 20 mg/kg for intravenous administration over approximately 4 hours every 2 weeks over a 24-week Treatment Period (total of 13 doses), and every 2 weeks over a 240-week Extension Period (up to 120 additional doses).

Protocol documents:
Clinical trial NCT02132312
Conditions: Unilateral Cataract Extraction Congenital Cataract
Keywords: Cataract Lens replacement pediatric
Sponsor: Omeros Corporation
Start date: 2014-07-01; Completion date: 2016-09-12
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in children birth through 3 years.

Detailed description:
This study is a randomized, parallel-group, double-masked, phenylephrine-controlled study of OMS302 in young children ages birth through three years undergoing unilateral cataract extraction with or without lens replacement. Administration of test irrigation solutions will take place in a double-masked fashion.

Intraoperative pupil size will be determined by measurement of pupil diameter from still photos captured from video recordings of the procedure. Pupil diameter measurements will be performed immediately prior to the initial incision and at one-minute intervals until the end of the procedure (wound closure). Pain will be assessed by the Alder Hey Triage Pain Score.

Arms: arm 1: OMS302 diluted in balanced salt solution (BSS) and administered as irrigation solution arm 2: Phenylephrine diluted in balanced salt solution (BSS) and administered as irrigation solution
Interventions: intervention 1: OMS302 intervention 2: Phenylephrine HCl
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02395653
Conditions: Pain, Postoperative
Keywords: Pediatric Postoperative Pain Management
Sponsor: The Medicines Company
Start date: 2015-06-29; Completion date: 2016-09-12
Enrollment: 71 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the safety and clinical utility of the active, SSEC fentanyl 40 micrograms (mcg) for the management of acute, postoperative pain in pediatric participants.

Detailed description:
An open label evaluation of the safety and clinical utility of the active, SSEC fentanyl 40 mcg for the management of acute postoperative pain in pediatric participants 12 to less than 18 years of age.

Arms: arm 1: SSEC fentanyl iontophoretic transdermal system, 40 mcg fentanyl per activation.
Interventions: intervention 1: fentanyl
Intervention descriptions: intervention 1: An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.

Protocol documents:
Clinical trial NCT02487446
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Novartis Pharmaceuticals
Start date: 2015-07-28; Completion date: 2016-09-12
Enrollment: 357 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate that the efficacy of the combination product QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.

Detailed description:

Arms: arm 1: Participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks. Then after 3 weeks washout, participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. arm 2: Participants received Umeclidinium/vilanterol 62.5/25 ug via inhalation once daily for 12 weeks. Then after 3 weeks washout, participants received QVA149 27.5/12.5 ug via inhalation twice daily (b.i.d.) for 12 weeks.
Interventions: intervention 1: QVA149 intervention 2: Umeclidinium/vilanterol intervention 3: Placebo (umeclidinium/vilanterol) intervention 4: Placebo (QVA149)
Intervention descriptions: intervention 1: QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI) intervention 2: Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler intervention 3: Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler intervention 4: Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI

Protocol documents:
Clinical trial NCT02632110
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Sponsor: DUSA Pharmaceuticals, Inc.
Start date: 2016-03-01; Completion date: 2016-09-12
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.

Detailed description:

Arms: arm 1: ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 2: Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 3: ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 4: Microneedle lesion preparation prior to ALA-PDT, 25 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 5: ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 6: Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 7: ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 8: Microneedle lesion preparation prior to ALA-PDT, 60 min incubation period, 20 mW/cm2 power density for 8 min 20 second light treatment. arm 9: Vehicle (VEH) PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment. arm 10: Microneedle lesion preparation prior to Vehicle PDT, 60 minute incubation period, 10 mW/cm2 power density for 16 min 40 second light treatment.
Interventions: intervention 1: ALA intervention 2: Topical Solution Vehicle intervention 3: IBL 10 mW intervention 4: Microneedle lesion preparation intervention 5: IBL 20 mW
Intervention descriptions: intervention 1: 20% ALA applied to face prior to light treatment intervention 2: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment intervention 3: 10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds intervention 4: Microneedling of all visible/palpable AK lesions prior to solution application. intervention 5: 10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds

Protocol documents:
Clinical trial NCT02668822
Conditions: Dysmenorrhea
Sponsor: Organon and Co
Start date: 2016-02-09; Completion date: 2016-09-12
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy of the etonogestrel (ENG) + 17β-estradiol (E2) (MK-8342B) vaginal ring compared to placebo vaginal ring in the treatment of dysmenorrhea at Treatment Cycle 2. This study was also to assess the safety and tolerability of the ENG-E2 vaginal rings over 4 treatment cycles. Primary hypothesis: Relative to the placebo ring, the ENG-E2 vaginal ring results in a greater proportion of participants with a ≥3-point reduction in peak pelvic pain score and no increase in the number of rescue pain relief (ibuprofen) tablets taken at Treatment Cycle 2 as compared to baseline.

Detailed description:
The cramping window for each participant was to be defined as a 4-day time interval that began the day prior to initiation of each cyclic bleeding episode (spontaneous menses or hormone withdrawal bleeding) and continued until the third bleeding day (inclusive). An external committee of blinded independent reviewers was to determine the 4-day cramping window for each participant so that analysis of the efficacy data could be conducted. The study was terminated early due to a business decision by the Sponsor to discontinue product development for reasons unrelated to safety or efficacy outcomes. Due to the early study termination, the blinded independent review committee that was supposed to determine the 4-day cramping windows for data analysis was not assembled; thus cramping windows were not determined. Without defined cramping windows, the efficacy outcome measures for this study could not be analyzed.

Arms: arm 1: Participants received up to 4 cycles of etonogestrel-17β estradiol (ENG-E2) at a daily dose of 125 μg/300 μg via vaginal ring. Each cycle consisted of 21 days of MK-8342B vaginal ring use followed by 7 ring-free days. arm 2: Participants received up to 4 cycles of placebo via vaginal ring. Each cycle consisted of 21 days of placebo vaginal ring use followed by 7 ring-free days.
Interventions: intervention 1: ENG 125 μg + E2 300 μg vaginal ring (MK-8342B) intervention 2: Placebo vaginal ring intervention 3: Ibuprofen
Intervention descriptions: intervention 1: Medicated vaginal ring intervention 2: Placebo vaginal ring intervention 3: Ibuprofen 400-mg tablets, to be taken orally, were provided to the participants for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may have taken 400 mg every 4 hours as needed for pelvic pain/cramping.

Protocol documents:
Clinical trial NCT02775240
Conditions: Cytomegalovirus (CMV)
Keywords: Maribavir
Sponsor: Shire
Start date: 2016-07-21; Completion date: 2016-09-12
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine how an investigational treatment (maribavir) is handled by the body when administered with two already approved drugs (digoxin and dextromethorphan). The study will also look at the safety and tolerability when maribavir is coadministered with digoxin and dextromethorphan versus digoxin and dextromethorphan alone.

Detailed description:

Arms: arm 1: On Day 1, subjects will receive a single 0.5 mg (2 x 0.25 mg) oral dose of digoxin. arm 2: On Day 8 through Day 15, subjects will receive a 400 mg (2 x 200 mg) BID oral dose of maribavir. Subjects will be given the second dose of maribavir approximately 12 hours after the first dose. On Day 13, subjects will receive a coadministration of a single 0.5 mg (2 x 0.25 mg) oral dose of digoxin and a single 30 mg oral dose of dextromethorphan given with the morning dose of maribavir. arm 3: On Day 1, subjects will receive a single 30 mg oral dose of dextromethorphan.
Interventions: intervention 1: Digoxin intervention 2: Maribavir intervention 3: Dextromethorphan
Intervention descriptions: intervention 1: 0.5 mg (2 x 0.25 mg) Digoxin oral dose intervention 2: 200mg twice a day for 8 days intervention 3: 30 mg oral dose

Protocol documents:
Clinical trial NCT02038764
Conditions: Diabetes Mellitus, Type 1
Keywords: Phase 1 RN168 Adults Type 1 Diabetes T1D
Sponsor: Pfizer
Start date: 2014-06-04; Completion date: 2016-09-13
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: 

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of multiple doses of PF-06342674. Several dose levels will be evaluated.

Detailed description:

Arms: arm 1: Placebo arm 2: None
Interventions: intervention 1: Placebo intervention 2: PF-06342674 Dose A intervention 3: PF-06342674 Dose B intervention 4: PF-06342674 Dose C intervention 5: PF-06342674 Dose D
Intervention descriptions: intervention 1: Placebo intervention 2: Multiple SC Doses intervention 3: Multiple SC Doses intervention 4: Multiple SC Doses intervention 5: Multiple SC Doses

Protocol documents:
Clinical trial NCT02046616
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2014-05-28; Completion date: 2016-09-13
Enrollment: 133 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.

Detailed description:

Arms: arm 1: All participants will receive tocilizumab as a single fixed dose (monotherapy) or in combination with methotrexate or other non-biologic DMARDs, irrespective of body weight, for 24 weeks.
Interventions: intervention 1: Tocilizumab intervention 2: Methotrexate intervention 3: Non-Biologic DMARDs
Intervention descriptions: intervention 1: Tocilizumab 162 mg will be administered subcutaneously QW. intervention 2: Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline. intervention 3: Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.

Protocol documents:
Clinical trial NCT02241187
Conditions: Pancreatic Cancer
Keywords: PEGPH20 Cetuximab 14-039
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2014-09-12; Completion date: 2016-09-13
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be studied. Also, the effects of PEGPH20 on tumors will be studied.

Detailed description:

Arms: arm 1: 5 participants will undergo DW- \& DCE-MRI for sequence parameter optimization. The 1st stage of the study, patients (n = 5) will have the option to undergo (DW-) \& (DCE)-MRI for repeatability investigation \& T1 mapping. Optional DW- \& DCE-MRI will be repeated 2 to 5 days later, followed shortly by administration of 1 intravenous dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.Blood samples will be drawn at various time points. The resected tumor specimen will be studied. If deemed safe, we will proceed to the second stage of the study. Patients (n = 5) will have the option to undergo DW- \& DCE-MRI. 1 to 3 days later, patients will receive 1 IV dose of PEGPH20 at 3 μg/kg/10 min. Optional DW- \& DCE-MRI will be repeated 1 to 2 days after PEGPH20 administration, followed on that day by administration of 1 IV dose of cetuximab at 250 mg/m2/60 min. Pancreatic tumor resection will be performed 1 to 2 days later.
Interventions: intervention 1: PEGPH20 intervention 2: Cetuximab intervention 3: DW & DCE-MRI intervention 4: blood draws
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: Blood samples will be drawn at various time points.

Protocol documents:
Clinical trial NCT02496000
Conditions: Diabetes Type 2
Keywords: Diabetes Mellitus type 2 Metformin oral insulin
Sponsor: Oramed, Ltd.
Start date: 2015-07-27; Completion date: 2016-09-13
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double-blind, placebo-controlled, parallel group study.

Detailed description:
This is a multicenter, Phase II, randomized, double-blind, placebo-controlled, parallel group study. After appropriate screening, approximately 180 male and female patients from up to 33 study centers will be treated in this study. Patients with type 2 diabetes mellitus who are being treated by diet, exercise, untreated with antidiabetic medications or treated with and metformin monotherapy or in combination with one other antidiabetic drug (excluding insulin) are eligible for enrollment.

Arms: arm 1: three identical capsules containing placebo arm 2: three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo arm 3: three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1
Interventions: intervention 1: ORMD-0801 intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: Oral Insulin intervention 2: Placebo

Protocol documents:
Clinical trial NCT02829814
Conditions: Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Musculoskeletal Diseases
Keywords: Pain Sleep Fibromyalgia FM
Sponsor: Tonix Pharmaceuticals, Inc.
Start date: 2016-07-22; Completion date: 2016-09-13
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The present trial is designed to assess the safety and efficacy of TNX-102 SL 2.8 mg tablets, taken daily at bedtime after 12 weeks of treatment in patients with fibromyalgia.

The use of low-dose sublingual formulation of cyclobenzaprine (TNX-102 SL) dosed nightly for fibromyalgia is supported by the results of TNX-CY-F202 Phase 2b study -- the results provide strong evidence that TNX-102 SL 2.8 mg dosed nightly results in beneficial effects upon pain, sleep and other FM symptomatology.

Detailed description:

Arms: arm 1: 1 x TNX-102 SL 2.8 mg Tablet taken sublingually each day at bedtime for 12 weeks arm 2: 1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks
Interventions: intervention 1: TNX-102 SL Tablet, 2.8 mg intervention 2: Placebo SL Tablet
Intervention descriptions: intervention 1: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. intervention 2: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.

Protocol documents:
Clinical trial NCT01610492
Conditions: Glomerulonephritis, Membranous
Keywords: IMGN anti-PLA2R antibodies pharmacokinetics belimumab Benlysta Idiopathic Membranous Glomerulonephropathy safety GSK1550188 Lymphostat-B membrane attack complex
Sponsor: GlaxoSmithKline
Start date: 2012-07-01; Completion date: 2016-09-14
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II, open label, experimental medicine study to evaluate the efficacy, safety and mechanism of action of belimumab in subjects with antiphospholipase A2 receptor (PLA2R) autoantibody positive idiopathic membranous glomerulonephropathy (IMGN), and to profile the relationship between biomarkers, autoantibody status and clinical response. 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) will be administered at weeks 0, 2, and then every 4 weeks, over a 24-week treatment period in subjects with anti-PLA2R antibody positive IMGN followed by a further long term treatment period until subjects reach remission of proteinuria, up to a maximum of 2 years total treatment. All subjects will receive background supportive therapy throughout the study. The dosing frequency will be adjusted to every 2 weeks if the subject's proteinuria as assessed by urinary protein creatinine ratio (PCR) is greater than 1000 milligrams per millimole (mg/mmol) \[greater than 10 grams(g)/24 hours (h)\], to compensate for loss of belimumab in the urine. Effects on mechanistic markers will be measured by the level of proteinuria, levels of anti-PLA2R antibodies, and various other measures of kidney function. These will be compared to historical data. The pharmacokinetics of belimumab will be measured to confirm dosing in heavily proteinuric subjects. Pharmacodynamic (PD) markers, biomarkers and Quality of Life(QoL) in IMGN subjects will also be investigated. Safety will be assessed by adverse events (AE), clinical laboratory evaluations, and vital signs.

Detailed description:

Arms: arm 1: 10mg/kg belimumab intravenous (IV) administered at weeks 0 and 2, and then every 4 weeks, over a 24-week treatment period, resulting in a total of 8 doses, and will be assessed for the primary endpoint at week 28. Subjects will then enter the long term phase of the study and receive 10mg/kg belimumab every 4 weeks until week 100,or until they have been in complete remission for at least 3 months, resulting in up to 27 doses.
Interventions: intervention 1: belimumab
Intervention descriptions: intervention 1: 10mg/kg administered intravenously

Protocol documents: