ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02059187
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-02-11; Completion date: 2015-03-11
Enrollment: 531 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in participants treated with MK-1293 compared with that in participants treated with Lantus™.

Detailed description:

Arms: arm 1: MK-1293 administered subcutaneously once daily in the evening. arm 2: Lantus™ administered subcutaneously once daily in the evening.
Interventions: intervention 1: MK-1293 intervention 2: Lantus™ intervention 3: Prandial insulin
Intervention descriptions: intervention 1: MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. intervention 2: Lantus™ (insulin glargine \[rDNA origin\]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time. intervention 3: Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.

Protocol documents:
Clinical trial NCT02127970
Conditions: Abscess Wound Infection Surgical Site Infection Cellulitis
Sponsor: Durata Therapeutics Inc., an affiliate of Allergan plc
Start date: 2014-04-18; Completion date: 2015-03-11
Enrollment: 698 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of treatment with a single dose of dalbavancin 1500 mg to treatment with a two dose regimen of dalbavancin (1000 mg on Day 1 followed by 500 mg on Day 8) in participants with known or suspected Gram-positive acute bacterial skin and skin structure infections (ABSSSI) at 48 -72 hours after initiation of treatment.

Detailed description:

Arms: arm 1: Single-dose of dalbavancin 1500 mg intravenous (IV) infusion over 30 minutes on Day 1 followed by dalbavancin-matching placebo IV infusion over 30 minutes on Day 8 for participants with creatinine clearance (CrCl) ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin dose was 1000 mg. arm 2: Two-dose regimen of dalbavancin 1000 mg IV infusion over 30 minutes on Day 1 followed by 500 mg IV infusion over 30 minutes on Day 8 for participants with CrCl ≥30 mL/min or with CrCl \<30 mL/min who were receiving regular hemodialysis or peritoneal dialysis. For participants with CrCl \<30 mL/min who were not receiving regular hemodialysis or peritoneal dialysis, the dalbavancin doses were 750 mg on Day 1 and 375 mg on Day 8.
Interventions: intervention 1: Dalbavancin intervention 2: Dalbavancin-matching Placebo
Intervention descriptions: intervention 1: Dalbavancin IV infusion over 30 minutes. intervention 2: Dalbavancin-matching placebo IV infusion over 30 minutes.

Protocol documents:
Clinical trial NCT01218438
Conditions: Primary Immunodeficiency Diseases (PID)
Sponsor: Baxalta now part of Shire
Start date: 2013-01-28; Completion date: 2015-03-13
Enrollment: 86 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to develop a 20% subcutaneous (SC) immunoglobulin preparation for the treatment of patients with primary immunodeficiency diseases (PIDD).

Detailed description:

Arms: arm 1: Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.

Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.

Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.

Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion.
Interventions: intervention 1: Immune Globulin Intravenous (Human), 10% Solution intervention 2: Immune Globulin Subcutaneous (Human), 20% Solution
Intervention descriptions: intervention 1: Intravenous infusion with IGIV, 10% intervention 2: Subcutaneous infusion with IGSC, 20%

Protocol documents:
Clinical trial NCT02062463
Conditions: Asthma
Keywords: Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2014-05-28; Completion date: 2015-03-13
Enrollment: 485 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is conducted to assess whether training participants on proper use of BF SPIROMAX and Symbicort TURBOHALER will improve their device-handling technique and potentially improve their treatment outcome, that is, better asthma control.

Detailed description:

Arms: arm 1: Participants will be trained on the proper use of empty Spiromax followed by empty Turbohaler devices. arm 2: Participants will be trained on the proper use of empty Turbohaler followed by empty Spiromax devices. arm 3: Participants who have currently received 800 to 1000 micrograms (μg) beclomethasone-equivalent inhaled corticosteroid (ICS) per day will receive budesonide/formoterol twice daily using the BF Spiromax 160/4.5 device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 640 μg and 18 μg, respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the BF Spiromax 320/9 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using BF Spiromax will be 1280 μg and 36 μg, respectively. arm 4: Participants who have currently received 800 to 1000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 200/6 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 800 μg and 24 μg respectively. Participants who have currently received 1600 to 2000 μg beclomethasone-equivalent ICS per day will receive budesonide/formoterol twice daily using the Symbicort Turbohaler 400/12 μg device. Therefore, the daily, ex-mouthpiece doses of budesonide and formoterol using Symbicort Turbohaler will be 1600 μg and 48 μg respectively.
Interventions: intervention 1: Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX intervention 2: SYMBICORT TURBOHALER budesonide and formoterol fumarate
Intervention descriptions: intervention 1: SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 μg) intervention 2: SYMBICORT® TURBOHALER® (200/6 and 400/12 μg)

Protocol documents:
Clinical trial NCT02078219
Conditions: Gout and Hyperuricemia
Sponsor: AstraZeneca
Start date: 2014-01-05; Completion date: 2015-03-13
Enrollment: 204 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.

Detailed description:

Arms: arm 1: RDEA3170 5mg followed by RDEA3170 7.5mg arm 2: RDEA3170 10mg followed by RDEA3170 12.5mg arm 3: RDEA3170 12.5mg followed by RDEA3170 15mg arm 4: RDEA3170 Placebo arm 5: Allopurinol 200mg
Interventions: intervention 1: RDEA3170 intervention 2: Allopurinol intervention 3: Placebo
Intervention descriptions: intervention 1: Oral Treatment intervention 2: Oral Treatment intervention 3: Oral Treatment

Protocol documents:
Clinical trial NCT05288660
Conditions: Healthy
Keywords: ALXN1210 Pharmacokinetic Pharmacodynamic Safety Immunogenicity
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2014-08-27; Completion date: 2015-03-13
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
This study evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of a single dose of ALXN1210 in healthy participants, as assessed by electrocardiograms, physical examination, vital signs, laboratory analysis, and assessment of adverse events (AEs).

Detailed description:
The participants were randomized in a 2:1 ratio (4 active and 2 placebo) to receive a single dose of ALXN1210 or placebo in the 200-milligram (mg) dose cohort and in a 3:1 ratio (6 active and 2 placebo) to receive a single dose of ALXN1210 or placebo in the 400-mg dose cohort, administered by intravenous (IV) infusion. A 150-day observation period was performed for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration. Antidrug antibody (ADA) levels were monitored in study participants for the duration of the 150-day follow-up period.

Arms: arm 1: ALXN1210 was administered intravenously. arm 2: ALXN1210 was administered intravenously. arm 3: Placebo was administered intravenously.
Interventions: intervention 1: ALXN1210 intervention 2: Placebo
Intervention descriptions: intervention 1: All doses of ALXN1210 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 milliliters \[mL\]/hour), excluding interruption for safety or technical reason. intervention 2: All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters, at a fixed rate of 686 mg/hour (equivalent to 137 mL/hour), excluding interruption for safety or technical reason.

Protocol documents:
Clinical trial NCT01280201
Conditions: Advanced/Metastatic Neuroendocrine Tumors
Keywords: Neuroendocrine Tumors Pazopanib GETNE Biomarkers
Sponsor: Grupo Espanol de Tumores Neuroendocrinos
Start date: 2011-01-26; Completion date: 2015-03-15
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The incidence of new diagnosed patients with NET of the digestive tract including carcinoid and pancreatic islet cells tumors ranges from 2 to 10 per 100,000 in the western Countries (Kulke M, Mayer R. N Engl J Med 340:858-868, 1999). Despite of the low incidence, the prevalence of these tumors is high because of their relatively long survival estimated in 35% at 5 years for those patients with well or moderate differentiated tumors (Yao JC, et al. J Clin Oncol. 2008;26:3063-3072). In fact, digestive NETs are the second most prevalent tumors derived from the digestive tract after colorectal carcinoma.

NETs are characterized by abundant vasculature, moreover VEGFR and VEGFR are overexpressed in 60-84% of the carcinoids and pancreatic islet cells NETs (Zhang et al. Cancer 2007;109:1478-1486). Other pro-angiogenic factors like the platelet derived growth factor (PDGFR) have been also involved in NET progression and development (Chaudhry A, et al.Cancer Res 1992;52:1006-12).

Pazopanib is an oral tyrosine kinase inhibitor of the VEGFR, PDGFR and KIT with a dual activity both as an antiangiogenic and also and anti-tumoral agent (Kumar et al. Mol Cancer Ther2007;6:2012-2021, Hurwitz et al. Clin Cancer Res 2009;15:4220-4227). Pazopanib seems to have a better toxicity profile versus the other antiangiogenic tyrosine kinase inhibitors and has already shown activity in several tumor types like renal cell carcinoma (Sternberg et al. J Clin Oncol 2009;27:abst. 5021), soft tissue sarcomas (Sleijfer et al. J Clin Oncol 2009;27:3126-32), hepatocellular carcinoma (Yau et al. J Clin Oncol 2009;27:abst. 3561), colorectal cancer (Brady et al. J Clin Oncol 2009;27:abst.4133), and thyroid cancers (Bible et al. J Clin Oncol 2009;27:abst. 3521).

The Spanish Group for Research in Neuroendocrine Tumors (GETNE) group is an active Member inside of the GENET group and has a large tradition in clinical trials in NETs. The investigators hypothesize that pazopanib may have at least as good activity and better safety profile than other VEGFR inhibitors in progressive advanced or metastatic NET tumors derived from the digestive tract.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Pazopanib
Intervention descriptions: intervention 1: Single arm of pazopanib 800 mg (2x400mg) given once daily as a single agent.

Protocol documents:
Clinical trial NCT01987908
Conditions: Sickle Cell Disease
Keywords: Pain Biomarkers 6 minute walk test 5-HMF Pharmacokinetics Analgesic use Sickle cell disease Aes-103 SpO2 Anemia Hemoglobin
Sponsor: Baxalta now part of Shire
Start date: 2013-12-03; Completion date: 2015-03-16
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Sickle cell disease (SCD) is a genetic blood disorder characterized by the presence of sickle-shaped red blood cells. In the U.S. and the U.K. this occurs primarily in persons of African origin. There is only one drug (hydroxyurea) approved to manage SCD, but it is not fully efficacious and can produce medically significant side effects. Aes-103 is being evaluated as a novel agent for the long term management of SCD. By directly reducing the sickling process, Aes-103 has a different mechanism of action than hydoxyurea. The active ingredient in Aes-103 is 5-hydroxymethyl furfural, a naturally occurring small molecule that is chemically related to glucose.

This study will evaluate the safety and pharmacokinetic profile of two dosing regimens of Aes-103 for up to 28 days in up to 50 adult subjects with stable SCD compared with subjects receiving placebo.

Detailed description:
This study will evaluate evaluate in subjects with stable SCD the safety, pharmacokinetic profile, clinical pharmacology actions and clinical activities of two dosing regimens of Aes-103 (1000 mg four times daily in Cohort A and a higher or lower dose given once daily or up to four times daily in Cohort B) given for up to 28 days in adult subjects with stable SCD compared with subjects receiving placebo.

Arms: arm 1: Subjects randomized 3:1 to receive 4 times daily dosing of 1,000 mg of Aes 103 or placebo for 28 days arm 2: Subjects randomized 3:1 to receive 4 times daily dosing of 1,000 mg of Aes 103 or placebo arm 3: In this adaptive design, the dose frequency and the total amount given per day to Cohort B will be adjusted depending on the tolerability, clinical pharmacology and clinical endpoint results of Cohort A. Study terminated prior to completion of Cohort A due to unblinding between study product and placebo groups for participant, site and Sponsor. The study was stopped before initiation of Cohort B. arm 4: The dosing regiment of placebo will match that of the Aes-103 treatment in Cohort B. Study terminated prior to completion of Cohort A due to unblinding between study product and placebo groups for participant, site and Sponsor. The study was stopped before initiation of Cohort B.
Interventions: intervention 1: Aes-103 intervention 2: Placebo
Intervention descriptions: intervention 1: The active ingredient in Aes-103 is 5-hydroxymethyl furfural (5-HMF). Aes-103 and matching placebo are administered in a liquid oral formulation. intervention 2: None

Protocol documents:
Clinical trial NCT02280473
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Start date: 2014-11-13; Completion date: 2015-03-16
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

Detailed description:

Arms: arm 1: Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. arm 2: REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
Interventions: intervention 1: Refresh Optive® Gel Drops intervention 2: REFRESH LIQUIGEL®
Intervention descriptions: intervention 1: Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days. intervention 2: REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Protocol documents:
Clinical trial NCT01771666
Conditions: Breast Cancer
Sponsor: Stanford University
Start date: 2012-07-01; Completion date: 2015-03-17
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.

Detailed description:
It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.

Arms: arm 1: The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started.

(IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.
Interventions: intervention 1: SPY Elite Imaging intervention 2: Indocyanine Green intervention 3: Isosulfan blue intervention 4: 99technetium-sulfur colloid radiolabel
Intervention descriptions: intervention 1: A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes intervention 2: started at 1mg /mL

If fluorescence is not detected with this dose, then it will be increased by 50%. intervention 3: 3 to 5 mL

If fluorescence is not detected with this dose, then it will be increased by 50%. intervention 4: None

Protocol documents:
Clinical trial NCT02117687
Conditions: Dry Eye Syndromes Keratoconjunctivitis Sicca
Sponsor: Allergan
Start date: 2014-05-14; Completion date: 2015-03-17
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of OPTIVE FUSION™ compared to VISMED® Multi for the management of dry eye.

Detailed description:

Arms: arm 1: 1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. arm 2: 1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
Interventions: intervention 1: carboxymethylcellulose 0.5%/glycerin 0.9% intervention 2: sodium hyaluronate 0.18%
Intervention descriptions: intervention 1: 1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months. intervention 2: 1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.

Protocol documents:
Clinical trial NCT01712009
Conditions: Bone Pain in Stage I - III Breast Cancer
Keywords: Breast cancer Chemotherapy Neulasta Pegfilgrastim Naproxen Loratadine Non-steroidal antiinflammatory drug (NSAID) Anti-histamine Bone Pain
Sponsor: Amgen
Start date: 2012-11-01; Completion date: 2015-03-18
Enrollment: 600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

Detailed description:
In this study, the investigational products are naproxen, a non-steroidal antiinflammatory drug (NSAID), and loratadine, an anti-histamine. Both agents are being investigated as prophylactic medications to reduce the incidence and/or severity of bone pain in breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy and pegfilgrastim prophylaxis.

Pegfilgrastim treatment is used to stimulate bone marrow to produce more neutrophils to help fight infections in patients undergoing chemotherapy.

Arms: arm 1: Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. arm 2: Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration. arm 3: Participants received adjuvant or neoadjuvant chemotherapy with pegfilgrastim prophylaxis.
Interventions: intervention 1: Naproxen intervention 2: Loratadine intervention 3: Pegfilgrastim intervention 4: Chemotherapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy. intervention 4: The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.

Protocol documents: