ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02068222
Conditions: Chronic Hepatitis C Hepatitis C Virus
Keywords: Hepatitis C HCV Interferon Free Chronic Hepatitis C Hepatitis C virus Hepatitis C Genotype 3
Sponsor: AbbVie
Start date: 2014-04-01; Completion date: 2015-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.

Detailed description:
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.

Arms: arm 1: ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
Interventions: intervention 1: ABT-450/ritonavir (r) intervention 2: ABT-530 intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet intervention 3: Tablet

Protocol documents:
Clinical trial NCT02070380
Conditions: Brain Disease
Keywords: confirmed brain disease highly suspected brain disease
Sponsor: Bracco Diagnostics, Inc
Start date: 2014-02-01; Completion date: 2015-03-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study aims at a comparison between MultiHance at a dose of 0.1 mmol/kg and 0.05 mmol/kg and Dotarem at a dose of 0.1 mmol/kg in brain tumor patients to show superiority of MultiHance.

Detailed description:
This crossover study aims at a comparison between 0.1 mmol/kg MultiHance and 0.1 mmol/kg Dotarem, between 0.05 MultiHance and 0.1 mmol/kg Dotarem in terms of diagnostic preference at CE-MRI in brain tumor patients to show superiority of MultiHance.

Arms: arm 1: MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg arm 2: MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg arm 3: Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg arm 4: Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg
Interventions: intervention 1: MultiHance 0.1 mmol/kg intervention 2: Dotarem intervention 3: MultiHance 0.05 mmol/kg
Intervention descriptions: intervention 1: MultiHance administered at 0.1 mmol/kg intervention 2: Dotarem administered at 0.1 mmol/kg intervention 3: MultiHance administered at 0.05 mmol/kg

Protocol documents:
Clinical trial NCT02077374
Conditions: Nonalcoholic Steatohepatitis Non-alcoholic Fatty Liver Disease
Keywords: NAFLD NASH
Sponsor: Conatus Pharmaceuticals Inc.
Start date: 2014-03-01; Completion date: 2015-03-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests

Detailed description:
This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.

Arms: arm 1: IDN-6556 capsules, 25 mg BID arm 2: Placebo BID
Interventions: intervention 1: IDN-6556 intervention 2: Placebo
Intervention descriptions: intervention 1: 25 mg BID for 28 days intervention 2: Placebo BID for 28 Days

Protocol documents:
Clinical trial NCT02086786
Conditions: Schizophrenia
Sponsor: Rovi Pharmaceuticals Laboratories
Start date: 2014-03-01; Completion date: 2015-03-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation (in situ microparticle, ISM) of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.

Detailed description:
This was a multicenter, open-label, two-arm, parallel-design, repeat-dose clinical study designed to evaluate the PK, safety, and tolerability of Risperidone ISM®, a new long-acting injectable formulation of the licensed drug risperidone, administered in the gluteal muscle or the deltoid muscle. Participants were patients with a diagnosis of schizophrenia capable of understanding, signing, and consenting to study participation on their own.

Objectives:

Primary Objective

• To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation of risperidone over four IM injections in the gluteal and deltoid muscle at 28 day intervals and at one dose strength (75 mg) in patients with schizophrenia.

Secondary Objectives

* To document the attainment of steady-state exposure by the injectable formulation ISM® of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.
* To perform a descriptive comparison of the PK data between the gluteal and the deltoid muscle administration of the injectable formulation ISM® of risperidone over four IM injections at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.
* To evaluate the safety and tolerability of the injectable formulation ISM® of risperidone after four IM injections in the gluteal muscle or deltoid muscle at 28-day intervals at one dose strength (75 mg) in patients with schizophrenia.

Exploratory Objectives

* To explore the efficacy of once every four weeks of the injectable formulation ISM® of risperidone after four IM injections in the gluteal muscle or deltoid muscle at 28-day (± 1 day) intervals at one dose strength (75 mg) in patients with schizophrenia.
* To characterize patients' metabolic phenotype (cytochrome P450 \[CYP\]2D6, CYP3A4) to explain any potential unexpected outlying PK value, and/or explore its relationship with any potential safety or tolerability issue.

Arms: arm 1: Risperidone ISM (75 mg) injection in the gluteal muscle at 28-day intervals arm 2: Risperidone ISM (75 mg) injection in the deltoid muscle at 28-day intervals
Interventions: intervention 1: Risperidone ISM
Intervention descriptions: intervention 1: Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.

Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals.

Protocol documents:
Clinical trial NCT02089113
Conditions: Post-Surgical Ocular Pain Post-Surgical Ocular Inflammation
Sponsor: Ocular Therapeutix, Inc.
Start date: 2014-04-01; Completion date: 2015-03-01
Enrollment: 241 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Detailed description:

Arms: arm 1: OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use arm 2: PV (placebo drug delivery vehicle)
Interventions: intervention 1: Dexamethasone intervention 2: Placebo Vehicle
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02100813
Conditions: Actinic Keratosis
Sponsor: LEO Pharma
Start date: 2014-05-01; Completion date: 2015-03-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To identify the Maximum Tolerated Dose levels of LEO 43204 after once daily treatment for two consecutive days and to evaluate efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Detailed description:

Arms: arm 1: Open-label, dose escalation, 2 days treatment arm 2: X dose for 2 days treatment arm 3: Y dose for 2 days treatment arm 4: Placebo for 2 days treatment
Interventions: intervention 1: LEO 43204 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02105272
Conditions: Glaucoma Ocular Hypertension
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2014-04-01; Completion date: 2015-03-01
Enrollment: 237 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.

Detailed description:

Arms: arm 1: Once daily arm 2: Once daily
Interventions: intervention 1: OPC-1085EL ophthalmic solution intervention 2: Latanoprost ophthalmic solution
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02109029
Conditions: Diabetes Mellitus, Type 1
Sponsor: Eli Lilly and Company
Start date: 2014-04-01; Completion date: 2015-03-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, and to measure the quantity of LY2605541 in fat tissue. The study has two parts. It involves intravenous (IV) infusion of the investigational drug and a procedure to measure concentrations in the fat tissue. Both parts of the study will be conducted in participants with type 1 diabetes mellitus (T1DM). Part A and B of the study might take up to 7 weeks to complete.

Detailed description:

Arms: arm 1: Part A Cohort 1: (low dose) priming dose (PD) of 2.00 units (U), 0.92 U/hour (U/h) constant infusion of insulin peglispro Part A Cohort 1: (high dose) PD of 8.00 U, 4.50 U/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 1) PD of 4.00 U, 1.84/h constant IV infusion of insulin peglispro Part A Cohort 2: (intermediate dose 2) PD of 6.0 U, 2.76 U/h constant IV infusion of insulin peglispro Part B Insulin Peglispro: PD of 6.00 U, 2.76 constant IV infusion of insulin peglispro and a constant infusion of 6 pico moles per kilogram per minute (pmol/kg/min). IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours). arm 2: Constant IV infusion ( 6 pico moles per kilogram perminute \[pmol/kg/min\]) of human insulin for up to 36 hours. IV infusion of sinistrin (250 mg/mL, SOC to achieve a steady state for up to 16 hours).
Interventions: intervention 1: Insulin Peglispro intervention 2: Human Insulin
Intervention descriptions: intervention 1: Administered IV intervention 2: Administered IV

Protocol documents:
Clinical trial NCT02137785
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
Sponsor: DUSA Pharmaceuticals, Inc.
Start date: 2014-05-01; Completion date: 2015-03-01
Enrollment: 269 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Levulan Photodynamic Therapy (PDT) is safe and effective in the treatment of actinic keratoses on the upper arms and hands

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aminolevulinic Acid (ALA) intervention 2: Topical Solution Vehicle intervention 3: Blue Light Photodynamic Therapy Illuminator (BLU-U)
Intervention descriptions: intervention 1: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light intervention 2: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light intervention 3: 10 J/cm2 blue light delivered at 10mW/cm2

Protocol documents:
Clinical trial NCT02158442
Conditions: Diabetes Infection
Keywords: Diabetes Lower limb infection Significant wound infections Intravenous antibiotics Timentin
Sponsor: Osprey Medical, Inc
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The use of the Percutaneous Isolated Limb Procedure (PILP) which enables the use of existing antibiotic therapies in a more targeted and concentrated fashion in patients with diabetes who have a significant lower limb infection and it is deemed that IV antibiotics are needed in order to salvage the limb or life.

Detailed description:
During the PILP procedure, the circulation of the limb is isolated separately from the general circulatory system thereby enabling the delivery of antibiotics only to the limb. Limb isolation is achieved by creating an "artificial" circuit where catheters are inserted into the major artery and vein of the lower limb.

Arms: arm 1: The Treatment Group received intravenous Timentin prior to their PILP procedure. arm 2: The Control Group received standard dosings of intravenous Timentin plus other standard care.
Interventions: intervention 1: Percutaneous Isolated Limb Perfusion (PILP) delivery intervention 2: Timentin
Intervention descriptions: intervention 1: The Percutaneous Isolated Limb Perfusion (PILP) delivery intervention procedure enables the use of existing antibiotic therapies in a more targeted and aggressive fashion; it addresses limitations associated with the use of conventional antibiotic drug delivery. As part of the procedure, the circulation of the limb is isolated separately from the general circulatory system enabling the delivery of antibiotic at high therapeutic doses that are not achievable when standard doses are administered intravenously. intervention 2: The Control Group will receive standard dosings of intravenous Timentin plus other standard care.

Protocol documents:
Clinical trial NCT02175121
Conditions: Diabetes Mellitus, Type II
Sponsor: Pfizer
Start date: 2014-08-01; Completion date: 2015-03-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is going to assess the safety and tolerability of PF-06291874 in adults with Type 2 Diabetes Mellitus as monotherapy, to evaluate the significance of overall glycemic control in these subjects.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: PF-06291874 intervention 3: PF-06291874 intervention 4: PF-06291874 intervention 5: PF-06291874
Intervention descriptions: intervention 1: Tablet, once daily for 28 days intervention 2: Tablet, 15 mg, once daily for 28 days intervention 3: Tablet, 35 mg, once daily for 28 days intervention 4: Tablet, 75 mg, once daily for 28 days intervention 5: Tablet, 150 mg, once daily for 28 days

Protocol documents:
Clinical trial NCT02181517
Conditions: Macular Degeneration
Sponsor: Allergan
Start date: 2014-07-01; Completion date: 2015-03-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

Detailed description:

Arms: arm 1: Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. arm 2: Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16. arm 3: Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
Interventions: intervention 1: abicipar pegol intervention 2: ranibizumab intervention 3: sham procedure
Intervention descriptions: intervention 1: Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8. intervention 2: Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16. intervention 3: Sham procedure to the study eye at weeks 12 and 16.

Protocol documents:
Clinical trial NCT02189317
Conditions: Anterior Cruciate Ligament Rupture
Sponsor: Emory University
Start date: 2014-08-01; Completion date: 2015-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes. Patients will be randomized into treatment and control arms. The treatment arm will include 40 patients receiving liposomal bupivacaine intra-operatively in addition to the current standard pain control regimen. The control group will include 40 patients receiving the standard post-operative pain control regimen. Patients will be assessed to identify differences in post-operative pain, satisfaction, as well as concomitant pain medication use. Post-operative range of motion will also be assessed.

Detailed description:

Arms: arm 1: This arm will receive Exparel arm 2: None
Interventions: intervention 1: Exparel
Intervention descriptions: intervention 1: For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly.

Protocol documents:
Clinical trial NCT02192684
Conditions: Insulin Sensitivity Obstructive Sleep Apnea
Keywords: obstructive sleep apnea insulin sensitivity cardiovascular risk positive airway pressure therapy
Sponsor: Stanford University
Start date: 2010-09-01; Completion date: 2015-03-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obstructive sleep apnea (OSA) and type 2 diabetes confer increasing economic, social, and public health burdens in the United States. That these diseases appear to co-exist and together increase one's risk of cardiovascular disease renders investigation into their shared pathophysiology even more urgent. Investigators will assess prevalence of insulin resistance, a precursor to diabetes, among overweight patients with OSA. Among those at highest risk of diabetes, investigators will randomize participants to pioglitazone or placebo to see the efficacy of the intervention on improving OSA, insulin resistance, and/or insulin secretion. In a separate intervention, investigators will evaluate the cardiometabolic benefits of continuous positive airway pressure (CPAP) for 12 weeks in patients with OSA. Investigators will also study subjects from the community without known sleep apnea, and assess whether insulin-resistant individuals are at risk for sleep apnea using clinical screening questionnaires.

Detailed description:

Arms: arm 1: pioglitazone 45 mg, oral, daily arm 2: Placebo, one pill daily
Interventions: intervention 1: Pioglitazone intervention 2: placebo
Intervention descriptions: intervention 1: 45 mg daily Insulin sensitizing intervention 2: Compare with pioglitazone

Protocol documents:
Clinical trial NCT02196077
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Budesonide and formoterol inhalation aerosol
Sponsor: Pearl Therapeutics, Inc.
Start date: 2014-08-01; Completion date: 2015-03-01
Enrollment: 180 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.

Detailed description:

Arms: arm 1: Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) arm 2: Budesonide and formoterol fumarate metered dose inhaler (BFF MDI)160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) arm 3: Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) arm 4: Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID) arm 5: Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
Interventions: intervention 1: BFF MDI 320/9.6 μg intervention 2: BFF MDI 160/9.6 μg intervention 3: BFF MDI 80/9.6 μg intervention 4: BD MDI 320 μg intervention 5: FF MDI 9.6 μg
Intervention descriptions: intervention 1: Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) intervention 2: Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) intervention 3: Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID) intervention 4: Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID) intervention 5: Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)

Protocol documents: