ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03496324
Conditions: Bioequivalence of the Test Formulation
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Start date: 2016-02-29; Completion date: 2016-05-06
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Bioequivalence evaluation of Nurofen for Children® with reference formulation of Algifor® Junior by determining and comparing the rate and extent of absorption in both fed and fasted states

Detailed description:

Arms: arm 1: Nurofen for Children® 400 mg/10 ml by mouth under fed condition

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA. arm 2: Nurofen for Children® 400 mg/10 ml by mouth under fasted condition.

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA. arm 3: Algifor® Junior 400 mg/20 ml by mouth under fed condition.

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA. arm 4: Algifor® Junior 400 mg/20 ml by mouth under fasted condition.

Subjects participated in Treatment Sequence: BACD, DCAB, ADBC and CBDA.
Interventions: intervention 1: Nurofen for Children® intervention 2: Algifor® Junior
Intervention descriptions: intervention 1: Nurofen for Children® 400 mg/10 ml intervention 2: Algifor® Junior 400 mg/20 ml

Protocol documents:
Clinical trial NCT00436917
Conditions: Breast Cancer Osteoporosis
Keywords: stage I breast cancer stage II breast cancer stage IIIA breast cancer osteoporosis
Sponsor: Mayo Clinic
Start date: 2006-04-01; Completion date: 2016-05-09
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Zoledronate may reduce bone loss in patients receiving letrozole for breast cancer.

PURPOSE: This clinical trial is studying how well zoledronate works in treating osteopenia or osteoporosis in postmenopausal women receiving letrozole for stage I, stage II, or stage IIIA primary breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Assess changes in total lumbar spine bone mineral density (BMD) from baseline to 12 months in postmenopausal women treated with zoledronate for osteopenia or osteoporosis and letrozole for hormone receptor-positive, stage I-IIIA primary breast cancer.

Secondary

* Determine changes in total lumbar spine BMD from baseline to 2, 3, 4, and 5 years in these patients.
* Determine changes in femoral neck BMD from baseline to 1, 2, 3, 4, and 5 years in these patients.
* Determine time to disease progression in these patients.

OUTLINE: This is an open-label, multicenter study.

* Adjuvant aromatase inhibitor therapy: Patients receive oral letrozole daily for up to 5 years in the absence of disease progression or unacceptable toxicity.
* Osteoporosis management: Patients receive zoledronate IV over 15 minutes on day 1. Patients also receive oral elemental calcium twice daily and oral vitamin D daily for 6 months. Treatment repeats every 6 months for up to 5 years in the absence of disease progression or unacceptable toxicity.

Patients undergo total lumbar spine and hip (femoral neck) bone density testing by dual energy x-ray absorptiometry (DXA) at baseline and annually for 5 years.

After completion of study therapy, patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Arms: arm 1: 4 mg 15 minutes IV infusion. If creatinine clearance is ≤ 60, dosage should be adjusted as follows:CrCl 50-60: 3.5 mg; CrCl 40-49: 3.3 mg; CrCl 30-39: 3.0 mg.
Interventions: intervention 1: zoledronic acid intervention 2: Letrozole as adjuvant therapy
Intervention descriptions: intervention 1: zoledronic acid intervention 2: standard care

Protocol documents:
Clinical trial NCT02322229
Conditions: Vitreomacular Traction Vitreomacular Adhesion
Keywords: VMT sVMA vitrectomy ocriplasmin
Sponsor: Alcon Research
Start date: 2015-05-26; Completion date: 2016-05-09
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.

Detailed description:

Arms: arm 1: Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection
Interventions: intervention 1: Ocriplasmin 0.125 mg in a 0.1 mL volume
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02324673
Conditions: Seizures
Keywords: Treatment-resistant seizures
Sponsor: INSYS Therapeutics Inc
Start date: 2015-04-13; Completion date: 2016-05-09
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion.

Participants will be pediatric (aged 1-17, inclusive), experiencing treatment-resistant seizures, and satisfy all inclusion/exclusion criteria.

Detailed description:

Arms: arm 1: Low Dose \[10 milligrams/kilogram/day (mg/kg/day)\] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 5 mg/kg in the morning on Day 1 followed by total dose of 10 mg/kg/day (5 mg/kg in the morning and 5 mg/kg in the evening) on Days 4 to 10. arm 2: Mid Dose \[20 mg/kg/day\] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 10 mg/kg in the morning on Day 1 followed by total dose of 20 mg/kg/day (10 mg/kg in the morning and 10 mg/kg in the evening) on Days 4 to 10. arm 3: High Dose \[40 mg/kg/day\] oral solution containing pharmaceutical grade cannabidiol (nonplant-based). Starting dose of 20 mg/kg in the morning on Day 1 followed by total dose of 40 mg/kg/day (20 mg/kg in the morning and 20 mg/kg in the evening) on Days 4 to 10.
Interventions: intervention 1: Cannabidiol Oral Solution
Intervention descriptions: intervention 1: An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).

Protocol documents:
Clinical trial NCT02500901
Conditions: Metastatic Prostate Cancer
Keywords: Enzalutamide Niraparib PARP-1 inhibitor PARP-2 inhibitor Castrate-Resistant Prostate Cancer
Sponsor: Paul Mathew, MD
Start date: 2016-03-01; Completion date: 2016-05-10
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I study to determine the safety and feasibility of the combination of enzalutamide and niraparib in subjects with metastatic castration-resistant prostate cancer (CRPC).

Detailed description:
OUTLINE: This is a multi-center trial.

INVESTIGATIONAL TREATMENT:

Each eligible subject will begin treatment with a 28-day enzalutamide 160 mg/day lead-in cycle. If a subject is able to tolerate the lead-in enzalutamide cycle without Grade 2 or Grade 2-4 drug-related toxicity, dose reduction, or missed doses due to toxicity, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg daily.

Niraparib will be dosed daily starting at 100mg (dose level 1). Six subjects will be enrolled per dose level. If less than 33% of the subjects experience a dose-limiting toxicity (DLT) at the beginning of cycle 2, then the daily dose of niraparib will escalate to 200mg (dose level 2). If dose level 2 is similarly tolerated, then the daily dose of niraparib escalate to 300mg (dose level 3).

The following required laboratory values must be obtained within 14 days prior to registration for protocol therapy:

Hematopoietic:

* White blood cell count (WBC) ≥ 1500/mm3
* Hemoglobin (Hgb) ≥ 9 g/dL
* Platelets ≥ 150,000/µL
* Absolute neutrophil count (ANC) ≥ 1500/mm3

Renal:

* Calculated creatinine clearance of ≥ 40 cc/min using the Cockcroft-Gault formula

Hepatic:

* Bilirubin ≤ 1.5 × upper limit of normal (ULN)
* Aspartate aminotransferase (AST, SGOT) ≤ 2.5 × ULN

Arms: arm 1: Subjects will receive enzalutamide 160 mg/day PO in a 28-day lead-in cycle to assess tolerability. If well-tolerated, cycle 1 of combined enzalutamide and niraparib will commence. Enzalutamide will continue at 160 mg PO daily. Niraparib will be administered in three dose-escalation cohorts of 100mg PO, 200mg PO or 300 mg PO daily. Six subjects will be enrolled at each dose level. Each cycle will be 28 days. Combination treatment will continue until documented progression, unmanageable toxicity, or subject or treating investigator decision to discontinue for any reason.
Interventions: intervention 1: Enzalutamide intervention 2: Niraparib
Intervention descriptions: intervention 1: Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason. intervention 2: Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.

Protocol documents:
Clinical trial NCT01500473
Conditions: Congenital Central Hypoventilation Syndrome
Sponsor: Children's Hospital Los Angeles
Start date: 2012-02-01; Completion date: 2016-05-11
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Background: Congenital Central Hypoventilation Syndrome (CCHS) is a rare disorder of automatic control of breathing. This disease can manifest as early as birth. Patients with this disease have a fundamental lack of central drive breathing. They do not mount any responses to hypoxia or hypercapnia during sleep or wakefulness. This places them at risk of injury or death whenever they are not consciously breathing. They require lifelong assisted ventilation while sleeping, and some while awake. Progesterone is a known respiratory stimulant in normal individuals, and it has been shown in one study of 2 patients that this drug may improve CO2 responsiveness in patients with CCHS. However, this observation requires confirmation.

Hypothesis: Exogenous progesterone (in oral contraception pills) will improve CO2 responsivity by hyperoxic hypercapnic ventilatory response testing, hypoxic responsivity using 5-breath nitrogen breathing, hyperoxic ventilatory response while breathing 100% oxygen, and improve spontaneous ventilation during sleep in CCHS females \>15-years of age. The progesterone will also depress ventilatory response using a hyperoxia test.

Study Methodology: Baseline measures of CO2 and oxygen responsivity, and spontaneous ventilation during sleep, will be performed at baseline and after 3-weeks of taking a progesterone containing oral contraceptive agent. CO2 responsivity will be measured using a hyperoxic hypercapnic ventilatory response test. Hypoxic responsivity will be measured using a 5-breath 100% nitrogen breathing test. Hyperoxic responsivity will be measured by having subjects breathe 100% oxygen for 2-minutes. Subjects will perform an overnight polysomnogram to assess adequacy of gas exchange during spontaneous breathing while asleep. A progesterone containing oral contraception pill will then be given for 3-weeks, and the above measures repeated. Serum progesterone will be measured at baseline and at the time of study.

Detailed description:

Arms: arm 1: open label studied on drug.
Interventions: intervention 1: Desogestrel
Intervention descriptions: intervention 1: Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel

Protocol documents:
Clinical trial NCT01668966
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2013-12-09; Completion date: 2016-05-11
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.

Detailed description:

Arms: arm 1: Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks.
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.

Protocol documents:
Clinical trial NCT02000440
Conditions: Glomerulosclerosis, Focal Segmental
Keywords: GW856553 Focal segmental glomerulosclerosis (FSGS) p38 mitogen-activated protein kinase (MAPK) inhibitor losmapimod nephrotic syndrome
Sponsor: GlaxoSmithKline
Start date: 2014-07-01; Completion date: 2016-05-11
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, multicenter, open-label Phase II, proof-of-mechanism study to evaluate the efficacy, safety, tolerability and pharmacokinetics of losmapimod in approximately 21 subjects with primary (idiopathic) focal segmental glomerulosclerosis (FSGS) and substantive proteinuria as indicated by a Urinary protein/creatinine Up/c ratio \>=2 gram/gram (g/g) or 24 hr urine protein \>=2 g/day. Losmapimod will be orally administered twice daily over a 24-week treatment phase followed by a 12-week follow-up for safety and relapse assessments.

Detailed description:

Arms: arm 1: The subjects will be administered with 7.5 mg (1 tablet) of losmapimod following the completion of the Baseline (time zero) assessments. Subjects will continue to take one tablet in the morning and one tablet in the evening for approximately 2 weeks. After all the pre-dose assessments are completed at the Week 2 visit, subjects will be administered the first 15 mg (2 tablets) dose. Subjects will continue to take two tablets in the morning and two tablets in the evening every day for approximately 22 weeks. Doses of study treatment will be separated by at least 6 hours
Interventions: intervention 1: Losmapimod
Intervention descriptions: intervention 1: Losmapimod (micronized GW856553X) will be supplied as a film coated white, 7 mm round, biconvex, plain faced, tablet. Oral doses of losmapimod, 7.5 mg (1 tablet) or 15 mg (2 tablets), will be taken twice daily (BID) with food and swallowed whole (not chewed or crushed)

Protocol documents:
Clinical trial NCT01695772
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2012-10-16; Completion date: 2016-05-12
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm, multicenter study evaluated the resection rate in participants with colorectal cancer and previously untreated unresectable liver-only metastases after adding bevacizumab to 5-FU based doublet chemotherapy in the neoadjuvant setting. Participants receive standard 5-FU based chemotherapy plus Avastin bevacizumab 5 milligrams per kilogram (mg/kg) every 2 weeks for a maximum of 12 cycles combined pre- and postoperatively, unless they experienced progressive disease or unacceptable toxicity.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: 5-FU based doublet chemotherapy intervention 2: bevacizumab
Intervention descriptions: intervention 1: Standard 5-FU based doublet chemotherapy. Protocol did not specify any particular chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels. intervention 2: 5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively

Protocol documents:
Clinical trial NCT02134210
Conditions: Plaque Psoriasis
Keywords: PsO
Sponsor: Coherus Biosciences, Inc.
Start date: 2014-06-16; Completion date: 2016-05-12
Enrollment: 521 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones).

Detailed description:
Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 75% improvement from baseline according to the Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and safety at a dosage of 50mg subcutaneous (Sc) twice weekly.

Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.

Arms: arm 1: Enbrel 50mg twice weekly times 12 weeks arm 2: CHS-0214 50mg twice weekly times 12 weeks
Interventions: intervention 1: Etanercept intervention 2: CHS-0214
Intervention descriptions: intervention 1: Head-to-head comparison intervention 2: None

Protocol documents:
Clinical trial NCT02832375
Conditions: Dentin Sensitivity
Sponsor: GlaxoSmithKline
Start date: 2016-03-01; Completion date: 2016-05-12
Enrollment: 242 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This single center, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.

Detailed description:
This will be a single center, three day, randomized, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participants with at least two sensitive teeth that meet all the criteria at the screening and baseline (pre-treatment) visits. DH will be assessed at baseline (pre-treatment), post-treatment and after 3 days twice daily brushing.

Arms: arm 1: Participants will be instructed to dose a dry toothbrush containing 0.454% w/w of stannous fluoride (1000 parts per million \[ppm\] fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. arm 2: Participants will be instructed to dose a dry toothbrush containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute.
Interventions: intervention 1: stannous fluoride intervention 2: sodium monofluorophosphate
Intervention descriptions: intervention 1: 0.454% w/w stannous fluoride containing 1100ppm of fluoride intervention 2: 0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride

Protocol documents:
Clinical trial NCT01980875
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Gilead Sciences
Start date: 2015-04-21; Completion date: 2016-05-13
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the effects of idelalisib with obinutuzumab versus the combination of chlorambucil and obinutuzumab on progression-free survival (PFS) in participants with previously untreated chronic lymphocytic leukemia (CLL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated those studies in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). All front-line studies of idelalisib, including this study, were also terminated.

Detailed description:

Arms: arm 1: Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks. Following 4 weeks of treatment, safety data will be reviewed by an independent data monitoring committee (DMC). If acceptable tolerability is observed, the randomized portion of the study will begin. arm 2: Participants will receive idelalisib for 96 weeks and obinutuzumab over 21 weeks. arm 3: Participants will receive obinutuzumab over 21 weeks and chlorambucil over 23 weeks.
Interventions: intervention 1: Idelalisib intervention 2: Chlorambucil intervention 3: Obinutuzumab
Intervention descriptions: intervention 1: 150 mg tablet administered orally twice daily intervention 2: 2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses intervention 3: 1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks

Protocol documents:
Clinical trial NCT02219516
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2014-08-01; Completion date: 2016-05-13
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.

Detailed description:

Arms: arm 1: RDEA3170 15 mg once daily fasted arm 2: RDEA3170 15 mg once daily fasted arm 3: RDEA3170 15 mg once daily fasted arm 4: RDEA3170 15 mg once daily fasted
Interventions: intervention 1: RDEA3170
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02565628
Conditions: Idiopathic Parkinson's Disease
Sponsor: Pfizer
Start date: 2015-11-16; Completion date: 2016-05-13
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess safety, tolerability and pharmacokinetic data for multiple doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study will assess whether PF-06669571 is able to demonstrate superior efficacy compared with placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.

Detailed description:

Arms: arm 1: Once daily (QD) for 7 days arm 2: QD for 7 days
Interventions: intervention 1: PF-06669571 intervention 2: Placebo
Intervention descriptions: intervention 1: 1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days intervention 2: Placebo

Protocol documents:
Clinical trial NCT02003573
Conditions: Leukemia, Myeloid, Acute
Sponsor: Boehringer Ingelheim
Start date: 2014-01-29; Completion date: 2016-05-15
Enrollment: 13 participants; Allocation: ; Intervention model: SEQUENTIAL

Brief summary:
Dose Escalation (MTD Finding) Phase: To investigate the maximum tolerated dose (MTD), safety and pharmacokinetics of different volasertib administration schedules in combination with decitabine in previously untreated AML patients \>= 65 years of age who are considered ineligible for standard intensive therapy, or patients with relapsed or refractory AML regardless of prior treatment status.

MTD Extension Phase: To collect additional data on safety, efficacy and pharmacokinetics of volasertib in combination with decitabine in previously untreated patients with AML \>= 65 years of age and considered ineligible for standard intensive therapy.

Detailed description:

Arms: arm 1: dose escalation and MTD (Maximum Tolerated Dose) Extension (Note: Decitabine is a Backbone Treatment and Volasertib is Investigational Medicinal Product (IMP))
Interventions: intervention 1: decitabine iv intervention 2: volasertib iv infusion
Intervention descriptions: intervention 1: decitabine iv fixed dose intervention 2: volasertib iv infusion (Body Surface Area (BSA) based dosing)

Protocol documents: