ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01687218
Conditions: HIV
Sponsor: CONRAD
Start date: 2013-09-25; Completion date: 2015-05-26
Enrollment: 195 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
MTN-017 is a Phase 2, multi-site, randomized, six-sequence, two three-period, open label crossover study, examining the effects of oral Truvada and reduced glycerin 1% tenofovir gel. The study population will be sexually active, HIV-uninfected males who are 18 years of age or older, who report a history of receptive anal intercourse in the past 3 months. Each of the study product regimens offers different advantages to participants seeking an effective HIV prevention agent. How these relative advantages will compare in terms of safety, acceptability, systemic and local absorption, and adherence will be examined within this study.

Detailed description:

Arms: arm 1: Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) arm 2: Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) arm 3: Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks) arm 4: Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) arm 5: Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks) arm 6: Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)
Interventions: intervention 1: Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet) intervention 2: Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel) intervention 3: Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00574873
Conditions: Chronic Myeloid Leukemia
Keywords: Bosutinib imatinib CML
Sponsor: Pfizer
Start date: 2008-02-05; Completion date: 2015-05-27
Enrollment: 502 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Two-arm, randomized, open-label trial designed to evaluate the efficacy and safety of bosutinib alone compared to imatinib alone in subjects newly diagnosed with chronic phase Chronic Myelogenous Leukemia (CML). The primary endpoint is cytogenetic response rate at one year.

Detailed description:

Arms: arm 1: Bosutinib arm 2: Imatinib
Interventions: intervention 1: Bosutinib intervention 2: imatinib
Intervention descriptions: intervention 1: 500 mg once daily, by mouth (tablet) with food preferably in the morning. Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent. intervention 2: 400 mg once daily, by mouth (tablet). Drug can be increased up to 600mg daily in case of lack of efficacy, and can be reduced to 300mg daily in case of toxicity. The drug will be given daily for up to 8 years until treatment failure, unacceptable toxicity, death or withdrawal of consent.

Protocol documents:
Clinical trial NCT00693992
Conditions: Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Non-Small Cell Lung Cancer AJCC v7
Sponsor: National Cancer Institute (NCI)
Start date: 2008-06-15; Completion date: 2015-05-28
Enrollment: 210 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized phase III trial studies sunitinib malate to see how well it works when given as maintenance therapy (meaning it is approved for treatment after chemotherapy) in patients with stage IIIB-IV non-small cell lung cancer who have responded to prior treatment with combination chemotherapy. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether sunitinib malate is effective in helping tumors continue to shrink or stop growing.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the effect of sunitinib (sunitinib malate) compared to placebo on progression-free survival (PFS) in advanced non-small cell lung cancer (NSCLC) patients who have had either stable or responding disease over the course of their initial 4 cycles of platinum-based therapy.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity of sunitinib compared to placebo in the maintenance setting.

II. To evaluate the additional response rate as a result of sunitinib in this setting.

III. To assess the impact of sunitinib on overall survival compared to the placebo arm.

IV. To assess the impact of sunitinib on delaying the time to deterioration in quality of life and symptom progression compared to placebo using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and Lung Cancer Module (LC13).

V. To assess vascular endothelial growth factor (VEGF) haplotypes in advanced non-small cell lung cancer and sunitinib maintenance.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 6 months for 1 year, and then periodically for 3 years.

Arms: arm 1: Patients receive sunitinib malate 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive placebo 37.5 mg PO once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Placebo intervention 3: Quality-of-Life Assessment intervention 4: Sunitinib Malate
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Given PO

Protocol documents:
Clinical trial NCT01218659
Conditions: Fabry Disease
Keywords: Amicus Therapeutics Galafold AT1001 Migalastat
Sponsor: Amicus Therapeutics
Start date: 2011-09-08; Completion date: 2015-05-28
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to compare the efficacy and safety of migalastat and enzyme replacement therapy (ERT) in male and female participants with Fabry disease who are currently receiving ERT and who have an alpha galactosidase-A (α Gal-A) mutation that is amenable to migalastat, based on the clinical trial human embryonic kidney cell (HEK) assay.

Detailed description:
This was a Phase 3, randomized, open-label, active-controlled study to evaluate the efficacy and safety of 150 milligrams (mg) of migalastat hydrochloride (migalastat) (equivalent to 123 mg of migalastat) once every other day (QOD) and ERT in male and female participants with Fabry disease who were receiving ERT and who have an α Gal-A mutation that is amenable to migalastat, based on the clinical trial HEK assay. This was a 2-part study. Part 1, the 18-month randomized phase, evaluated participants who received either migalastat 150 mg QOD or ERT per prescribing physicians' instructions for efficacy and safety. Part 2, the optional 12-month open-label extension (OLE) phase in which all participants received migalastat, also explored efficacy and safety. For Part 2, all participants who received ERT in Part 1 were given migalastat. Data presented in this posting include efficacy data from the 18-month randomized period and safety data from the entire study (18-month randomized period and 12-month optional OLE \[total of 30 months\]).

Arms: arm 1: Participants received 150 mg migalastat orally QOD during the 18-month randomized treatment period and the optional 12-month OLE period. Participants received an inactive reminder capsule on alternate days during both treatment periods. arm 2: Participants received ERT (either agalsidase alfa or agalsidase beta) as prescribed by the participant's treating physician and administered in accordance with the approved prescribing information during the 18-month randomized treatment period. Participants were required to be given \>80% of the currently labeled dose and regimen during the 18-month randomized treatment period. During the optional 12-month OLE period, participants received 150 mg migalastat orally QOD. Participants received an inactive reminder capsule on alternate days during the OLE.
Interventions: intervention 1: migalastat hydrochloride intervention 2: agalsidase
Intervention descriptions: intervention 1: 150-mg capsule administered orally QOD intervention 2: Agalsidase via intravenous infusion as prescribed by the participant's treating physician and in accordance with the approved prescribing information

Protocol documents:
Clinical trial NCT01543204
Conditions: Psoriasis
Keywords: plaque psoriasis etanercept adalimumab
Sponsor: Amgen
Start date: 2012-02-01; Completion date: 2015-05-29
Enrollment: 64 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy of etanercept in patients with plaque psoriasis who have lost a satisfactory response to adalimumab.

Detailed description:

Arms: arm 1: Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01519947
Conditions: Anemia, Kidney Disease, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2012-05-30; Completion date: 2015-05-30
Enrollment: 87 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This comparative, open-label, multicenter, parallel-group study evaluated the effect of altitude on the dose requirements of Mircera (methoxy polyethylene glycol-epoetin beta) to achieve a target hemoglobin concentration of 11-12 grams per deciliter (g/dL) in participants with chronic renal anemia in pre-dialysis and dialysis. Four groups of participants, at sea level (below 50 meters) or an altitude above 1800 meters, and pre-dialysis or dialysis, received 50-250 micrograms (mcg) Mircera subcutaneously (SC), according to the local prescribing label.

Detailed description:

Arms: arm 1: Participants received 50-250 mcg SC according to local label. arm 2: Participants received 50-250 mcg SC according to local label. arm 3: Participants received 50-250 mcg SC according to local label. arm 4: Participants received 50-250 mcg SC according to local label.
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: Participants received 50-250 mcg SC according to local label

Protocol documents:
Clinical trial NCT01668017
Conditions: Advanced Solid Tumors Hepatocellular Carcinoma
Keywords: Advanced solid tumors Hepatocellular carcinoma cancer, liver
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2012-09-30; Completion date: 2015-05-31
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two-part trial. "Solid tumor" in this protocol means solid tumor excluding hepatocellular carcinoma (HCC).

Part 1: Dose Escalation Phase in subjects with solid tumor (Cohort A) and HCC (Cohort B). The dose will be increased from 45 mg twice a day (BID) with 3+3 cohort method up to the recommended phase 2 dose (RP2D) of pimasertib established as single agent in the global studies for each arm independently.

Part 2: The Maximum Tolerated Dose (MTD) defined in Part 1 will be confirmed in more subjects in Cohort A (N=18) and Cohort B (N=6) separately.

Following the recommendation by the Safety Monitoring Committee, Cohort B was discontinued due to hepatocellular carcinoma (HCC) and there will be no further enrollment of subjects to this cohort. This decision is based upon review of safety and efficacy information.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Pimasertib intervention 2: Pimasertib intervention 3: Pimasertib intervention 4: Pimasertib intervention 5: Pimasertib
Intervention descriptions: intervention 1: Subjects with solid tumor will be administered with Pimasertib 30 mg twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject. intervention 2: Subjects with solid tumor will be administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject. intervention 3: Subjects with solid tumor will be administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject. intervention 4: Subjects with HCC will be administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject. intervention 5: Subjects with HCC will be administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.

Protocol documents:
Clinical trial NCT02417831
Conditions: Prostatic Hyperplasia
Sponsor: Boehringer Ingelheim
Start date: 2015-04-30; Completion date: 2015-05-31
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A bio-equivalence of 2 different capsule formulations in fasted subjects

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tamsulosin capsules intervention 2: tamsulosin HCl
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00514514
Conditions: Kidney Transplantation
Keywords: Everolimus mycophenolate CNI-free kidney transplantation
Sponsor: Novartis Pharmaceuticals
Start date: 2007-07-01; Completion date: 2015-06-01
Enrollment: 802 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.

Detailed description:

Arms: arm 1: Myfortic, Sandimmun Optoral and corticosteroids arm 2: CNI free regimen: comprising the following steps for switching treatment:

Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids arm 3: CNI low regimen: comprising the following steps for switching treatment:

Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids
Interventions: intervention 1: Everolimus intervention 2: Myfortic intervention 3: Sandimmun Optoral intervention 4: Simulect®
Intervention descriptions: intervention 1: Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen intervention 2: 1 tablet containing 180 mg or 360 mg

Dosing schedule:

Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day) intervention 3: 1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level intervention 4: Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4

Protocol documents:
Clinical trial NCT01196091
Conditions: Systemic Lupus Erythematosus Connective Tissue Disease Autoimmune Disease
Keywords: Lupus SLE Systemic Lupus Erythematosis autoimmune disease LY2127399 Immune system disease
Sponsor: Eli Lilly and Company
Start date: 2010-12-01; Completion date: 2015-06-01
Enrollment: 1164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this SLE study is to evaluate the efficacy, safety and tolerability of two different doses of LY2127399 administered in participants with active SLE.

Detailed description:

Arms: arm 1: Administered SC arm 2: During the Treatment Period, for blinding purposes, patients will alternate injections of LY2127399 and injections of placebo every 2 weeks. arm 3: Administered SC
Interventions: intervention 1: LY2127399 intervention 2: Placebo every 2 weeks intervention 3: Placebo every 4 weeks intervention 4: Standard of Care
Intervention descriptions: intervention 1: 120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug. intervention 2: Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose intervention 3: Administered via subcutaneous injection for 52 weeks. intervention 4: None

Protocol documents:
Clinical trial NCT01373151
Conditions: Rheumatoid Arthritis
Sponsor: CSL Behring
Start date: 2011-06-01; Completion date: 2015-06-01
Enrollment: 418 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.

Detailed description:

Arms: arm 1: BMS-945429 Placebo/BMS-945429+Methotrexate+Adalimumab Placebo arm 2: BMS-945429 + Methotrexate + Adalimumab Placebo arm 3: BMS-945429 + Methotrexate + Adalimumab Placebo arm 4: BMS-945429 + Methotrexate + Adalimumab Placebo arm 5: BMS-945429 + Methotrexate/Methotrexate Placebo + Adalimumab Placebo arm 6: BMS-945429 + Methotrexate/Methotrexate Placebo+Adalimumab Placebo arm 7: Adalimumab + Methotrexate
Interventions: intervention 1: BMS-945429 Placebo intervention 2: BMS-945429 intervention 3: BMS-945429 intervention 4: BMS-945429 intervention 5: BMS-945429 intervention 6: Methotrexate intervention 7: Methotrexate intervention 8: Methotrexate Placebo intervention 9: Methotrexate intervention 10: Adalimumab Placebo intervention 11: Adalimumab
Intervention descriptions: intervention 1: Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only intervention 2: Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only intervention 3: Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks intervention 4: Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48 intervention 5: Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks intervention 6: Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only intervention 7: Tablets, Oral, 15 mg, Weekly, 48 weeks intervention 8: Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only intervention 9: Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only intervention 10: Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks intervention 11: Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks

Protocol documents:
Clinical trial NCT01836523
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2013-11-01; Completion date: 2015-06-01
Enrollment: 1398 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted globally. The aim of the trial is to confirm the efficacy and safety of liraglutide as adjunct therapy to insulin in the treatment of type 1 diabetes. The total trial duration per subject is approximately 58 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: liraglutide intervention 2: placebo intervention 3: liraglutide intervention 4: placebo intervention 5: liraglutide intervention 6: placebo
Intervention descriptions: intervention 1: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily. intervention 2: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily. intervention 3: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily. intervention 4: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily. intervention 5: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily. intervention 6: Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.

Protocol documents: