ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01475721
Conditions: Asthma
Keywords: ADVAIR Asthma safety FLOVENT
Sponsor: GlaxoSmithKline
Start date: 2011-11-18; Completion date: 2015-06-23
Enrollment: 11751 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.

Detailed description:
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.

Arms: arm 1: experimental drug arm 2: experimental drug arm 3: experimental drug arm 4: active comparator arm 5: active comparator arm 6: active comparator
Interventions: intervention 1: ADVAIR 100/50mcg intervention 2: ADVAIR 250/50mcg intervention 3: ADVAIR 500/50mcg intervention 4: FLOVENT 100mcg intervention 5: FLOVENT 250mcg intervention 6: FLOVENT 500mcg
Intervention descriptions: intervention 1: fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months intervention 2: fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months intervention 3: fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months intervention 4: fluticasone propionate (100) twice daily (AM and PM) for 6 months intervention 5: fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months intervention 6: fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months

Protocol documents:
Clinical trial NCT01271504
Conditions: Hepatocellular Carcinoma
Keywords: Cancer liver hepatocellular carcinoma phase I phase II
Sponsor: Eisai Inc.
Start date: 2011-07-19; Completion date: 2015-06-23
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether patients with hepatocellular carcinoma who receive either E7050 administered with Sorafenib or Sorafenib alone experience greater benefit (cancer responds to treatment) when E7050 is administered with Sorafenib.

Detailed description:
This open-label, multicenter, randomized study will consist of a Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with sorafenib; and a Phase II portion: a randomized 2-arm period. Approximately 95 patients with hepatocellular carcinoma will be enrolled in the study (10-15 patients in the Phase Ib portion and 80 patients in the Phase II portion). Patients will only participate in either the Phase Ib or the Phase II portion of the study. In both Phase Ib and phase II, Patients will receive study treatment (E7050 plus sorafenib or sorafenib alone) until the occurrence of progressive disease (PD)for approximately six 28-day cycles (24 weeks). After 6 cycles. ath the discretion of the Investigator and in consultation with the Medical Monitor, patients who are experiencing clinical benefit may continue E7050, with or without sorafenib (Arm 1), or may continue sorafenib alone (Arm 2), depending on the original randomization treatment arm, for as long as clinical benefit is sustained and the treatment is well tolerated. Patients will be followed until death following completion of therapy.

Arms: arm 1: Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib arm 2: Phase II: Arm 1; E7050 + 400 mg Sorafenib Arm 2; 400 mg Sorafenib
Interventions: intervention 1: Sorafenib intervention 2: Sorafenib
Intervention descriptions: intervention 1: Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib intervention 2: E7050 given orally at 200, 300 or 400 mg once daily.

Sorafenib given orally, 400 mg twice daily.

Protocol documents:
Clinical trial NCT01527500
Conditions: Geographic Atrophy Age-related Macular Degeneration
Keywords: AMD Age-related Macular Degeneration geographic atrophy GA Dry AMD Blindness Drusen GA lesion
Sponsor: Novartis Pharmaceuticals
Start date: 2012-01-25; Completion date: 2015-06-24
Enrollment: 158 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted in two parts; Part A and Part B: Part B was initially planned to include two cohorts. Cohort 2 was cancelled following an interim analysis for efficacy in Part A of the study, and not due to any safety issues or concerns. Cohort 2 is not referred to again and part B cohort 1 is referred to as part B alone in the remainder of the document and is the subject of this report.

Part B was conducted to assess the safety and tolerability of a single intravitreal (IVT) LFG316 10 mg/100 µL injection. There was no efficacy evaluation in Part B. The study employed a multicenter, randomized, sham - controlled, single masked design. Eight patients with advanced AMD were planned to be randomized in a 3:1 ratio to receive a single IVT dose of LFG316 (10 mg/100 µL) or sham injection. Patients assigned to a sham injection were treated the same as those assigned to LFG316, except that the hub of an empty syringe (without needle) was placed against the eye instead of the IVT injection.

Detailed description:

Arms: arm 1: LFG316 10 mg/100 μL arm 2: Sham injection arm 3: LFG316 5 mg/ 50 μL
Interventions: intervention 1: LFG316 intervention 2: Sham intervention 3: LFG316 Lower dose
Intervention descriptions: intervention 1: LFG316 5 mg/50 μL solution for IVT injection, intervention 2: Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given) intervention 3: LFG316 5 mg/50 μL solution for IVT Injection

Protocol documents:
Clinical trial NCT01816165
Conditions: Type 1 Diabetes
Keywords: diabetes insulin blood vessel type 1
Sponsor: University of Colorado, Denver
Start date: 2011-06-01; Completion date: 2015-06-24
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Insulin resistance (IR) is an important contributor to increased cardiovascular disease risk in type 1 diabetes (T1D). Non-esterified fatty acid elevation is a significant contributor to IR in T1D and may be a target of intervention. The hypothesis of the study is that isolated fatty acid lowering with acipimox will improve insulin action and blood vessel function and have the benefit of reducing mitochondrial oxidant generation and improving mitochondrial function in T1D. Targeting IR through fatty acid lowering is a novel approach to T1D treatment that may significantly improve current management of TID and of cardiovascular disease (CVD) risk in this high risk population.

Detailed description:

Arms: arm 1: Drug: acipimox arm 2: Drug: Placebo
Interventions: intervention 1: Acipimox intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day. intervention 2: Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day

Protocol documents:
Clinical trial NCT01982760
Conditions: Postoperative Ecchymosis
Keywords: Rhinoplasty Ecchymosis Edema
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2013-12-01; Completion date: 2015-06-25
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.

Detailed description:

Arms: arm 1: Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. arm 2: Patients Will not receive DDAVP prior to Rhinoplasty
Interventions: intervention 1: DDAVP
Intervention descriptions: intervention 1: Patients Receiving DDAVP prior to operation

Protocol documents:
Clinical trial NCT02159040
Conditions: High Risk MDS
Keywords: Int-2 MDS
Sponsor: Novartis Pharmaceuticals
Start date: 2014-09-11; Completion date: 2015-06-26
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to compare the overall response rate (inclusive of complete response, partial response and hematologic improvement) per IWG 2006 criteria in patients with higher risk MDS treated with azacitidine with or without deferasirox achieved over the course of one year. Hematologic improvement must be maintained for at least 8 weeks.

Detailed description:

Arms: arm 1: 75mg/m2 7days/28 day cycle arm 2: azacitidine 75mg/m2 7 days/28 day cycle deferasirox 10 mg/kg/day
Interventions: intervention 1: Azacitidine intervention 2: Azacitidine plus Deferasirox
Intervention descriptions: intervention 1: SC or IV AZA at 75mg/m2 7 days/28 day cycle intervention 2: SC or IV AZA at 75mg/m2 7 days/28 day cycle DFX 10mg/kg/day

Protocol documents:
Clinical trial NCT01529112
Conditions: Non-Small Cell Lung Cancer
Keywords: Locally Advanced Metastatic Non-Squamous Non-Small Cell Lung Cancer
Sponsor: Eisai Inc.
Start date: 2011-11-01; Completion date: 2015-06-27
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the overall survival of patients receiving E7080 + Best Supportive Care (BSC) with those receiving placebo + Best Supportive Care.

Detailed description:
This double-blind, placebo-controlled, multicenter, randomized Phase II study will consist of a 2-arm design, comparing E7080 + BSC (Arm 1) with placebo + BSC (Arm 2). Participants will be randomized in the ratio of 2:1 to receive either E7080 or placebo in a blinded manner.

Arms: arm 1: Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle plus Best Supportive Care (BSC) arm 2: Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle plus BSC
Interventions: intervention 1: Lenvatinib intervention 2: Lenvatinib matched placebo intervention 3: BSC
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01891669
Conditions: Neoplasms Carcinoma, Non Small Cell Lung Breast Neoplasms Ovarian Neoplasms
Keywords: ADC 5T4 PF-06263507 solid tumors lung cancer breast cancer ovarian cancer cancer tumors neoplasm metastasis
Sponsor: Pfizer
Start date: 2013-08-08; Completion date: 2015-06-29
Enrollment: 26 participants; Allocation: ; Intervention model: 

Brief summary:
To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-06263507 intervention 2: PF-06263507
Intervention descriptions: intervention 1: Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined. intervention 2: Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.

Protocol documents:
Clinical trial NCT02045797
Conditions: Infections, Bacterial
Keywords: Dose ranging Intravenous Adaptive design suspected or confirmed gram-positive acute bacterial skin and skin structure infection Subjects infection Oral GSK2140944
Sponsor: GlaxoSmithKline
Start date: 2014-03-24; Completion date: 2015-06-29
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study designed to select the optimal dose by further characterizing the safety, tolerability and PK of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care to treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure infections (ABSSSI). The selected dose will be used in future studies.

Detailed description:

Arms: arm 1: Subject will receive GSK2140944 750mg IV every 12 hours (q12h; twice daily \[BID\]) on Day 1 and Day 2. Subject may switch to GSK2140944 1500mg orally (PO) q12h (BID) at investigator's decision or will continue to receive GSK2140944 750mg IV q12h (BID) from Day 3 to Day 10. arm 2: Subject will receive GSK2140944 1000mg IV q12h (BID) on Day 1 and Day 2 . Subject may switch to GSK2140944 2000mg PO q12h (BID) at investigator's decision or will continue to receive GSK2140944 1000mg IV q12h (BID) from Day 3 to Day 10. arm 3: Subject will receive GSK2140944 1000mg IV q8h (TID) on Day 1 and Day 2. Subject may switch to GSK2140944 2000mg PO q8h (TID) at investigator's decision or will continue to receive GSK2140944 1000mg IV q8h (TID) from Day 3 to Day 10.
Interventions: intervention 1: GSK2140944 Lyophile intervention 2: GSK2140944 Capsules
Intervention descriptions: intervention 1: GSK2140944 Lyophile (pale yellow to grayish yellow cake) containing 750 mg of GSK2140944 (as free base) per vial for IV infusion. intervention 2: GSK2140944 500 mg capsules will be supplied as pink hard gelatin capsule with no external markings filled with slightly agglomerated pale yellow to grayish yellow powder.

Protocol documents:
Clinical trial NCT00194987
Conditions: Alloimmune Thrombocytopenia Fetal Alloimmune Thrombocytopenia
Keywords: Alloimmune thrombocytopenia Fetal alloimmune thrombocytopenia
Sponsor: Weill Medical College of Cornell University
Start date: 2001-04-01; Completion date: 2015-06-30
Enrollment: 102 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purposes of this study are to provide medical management by giving treatment to the mother that will bring up the fetal platelet count and to minimize the number of invasive procedures to the fetus (which may result in serious fetal injuries).

Detailed description:

Arms: arm 1: IVIG 2 g/kg/wk divided into 2 infusions per week for women with a fetus affected by FNAIT arm 2: IVIG 1 g/kg/wk in 1 infusion per week + prednisone 0.5 mg po daily for women with a fetus affected by FNAIT
Interventions: intervention 1: IVIG (Intravenous Immunoglobulin) intervention 2: prednisone
Intervention descriptions: intervention 1: one gram per kg of IVIG per infusion given either once or twice intervention 2: in arm with IVIG 1 gm/kg/wk will also receive prednisone 0.5 mg/kg/day

Protocol documents:
Clinical trial NCT01752985
Conditions: Diabetic Kidney Disease
Sponsor: Bristol-Myers Squibb
Start date: 2013-03-18; Completion date: 2015-06-30
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether BMS-813160 will reduce the amount of protein loss in the urine of subjects with type 2 diabetes and diabetic kidney disease

Detailed description:

Arms: arm 1: BMS-813160 150 mg capsules by mouth in AM and Placebo matching with BMS-813160 in PM for 12 weeks arm 2: BMS-813160 300 mg capsules by mouth twice daily for 12 weeks arm 3: Placebo matching with BMS-813160 0 mg capsules by mouth twice daily for 12 weeks
Interventions: intervention 1: BMS-813160 intervention 2: Placebo matching with BMS-813160
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02397408
Conditions: Prostate Cancer
Sponsor: University of California, San Francisco
Start date: 2015-04-09; Completion date: 2015-06-30
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well 11C-choline (carbon C 11 choline) and 18F-choline (fluorine F 18 choline) positron emission tomography/magnetic resonance (PET/MR) imaging works in diagnosing patients with unfavorable intermediate to high-risk prostate cancer. Diagnostic procedures, such as 11C- and 18F-choline PET/MR may help find and diagnose prostate cancer and find out how far the disease has spread.

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the ability of 11C- and 18F-choline PET/MR to detect and localize prostate cancer within the prostate gland.

SECONDARY OBJECTIVES:

I. To assess the ability of 11C- and 18F-choline PET/MR to detect the specific location of metastatic prostate cancer within pelvic lymph node regions in patients undergoing radical prostatectomy and extended pelvic lymph node dissection.

II. To assess the comparative performance of 11C- and 18F-choline PET/MR to already available imaging scans (bone scan, sodium fluoride positron emission tomography/computed tomography \[NaF PET/CT\], multiparametric1H magnetic resonance imaging \[MRI\], and/or pelvic CT scans) for detecting and localization of disease within the prostate, lymph nodes, and distant metastatic sites.

III. To determine the temporal distribution of 11C- and 18F-choline radiotracer in patients. The tissue uptake, retention, and clearance will be determined.

EXPLORATORY OBJECTIVES:

I. To compare regions of uptake on the 11C- and 18F-choline PET/MR to that on the sentinel lymph node imaging scans in patients undergoing sentinel lymph node-guided extended pelvic lymph node dissection.

OUTLINE:

Patients undergo 11C- and 18F-choline whole-body PET/MR imaging. After completion of study treatment, patients are followed up for 3 hours

Arms: arm 1: Patients are given 370 megabecquerel (MBq) 11C-Choline (11C) intravenously and 3 MBq/kg 18F-Choline (18F) intravenously prior to a whole-body PET/MR imaging
Interventions: intervention 1: Carbon C 11 Choline intervention 2: Fluorine F 18 Choline intervention 3: Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)
Intervention descriptions: intervention 1: Given intravenously (IV) prior to imaging intervention 2: Given intravenously (IV) prior to imaging intervention 3: Undergo whole-body PET/MR imaging

Protocol documents:
Clinical trial NCT02440308
Conditions: Prostate Carcinoma
Sponsor: Stanford University
Start date: 2015-04-01; Completion date: 2015-06-30
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial studies the use of gallium-68 (68Ga)-DOTA-Bombesin as the imaging agent for positron emission tomography (PET)/magnetic resonance imaging (MRI), collectively PET-MRI, in patients with prostate cancer. PET uses a radioactive substance called 68Ga-DOTA-Bombesin, which attaches to tumor cells with specific receptors on their surfaces. The PET scanner takes pictures that capture where the radioactive drug is "lighting up" and attaching to tumor cells, which may help doctors recognize differences between tumor and healthy prostate tissue. MRI uses radio waves and a magnet to make a picture of areas inside the body. Using 68Ga-DOTA-Bombesin in diagnostic procedures, such as PET/MRI, may allow doctors to identify smaller tumors than standard imaging.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the feasibility and biodistribution of 68Ga-DOTA-Bombesin (BAY 86-7548 or 68Ga-DOTA RM2).

OUTLINE:

Patients receive 68Ga-DOTA-Bombesin intravenously (IV) and then undergo PET/MRI approximately 1 hour later.

After completion of study, patients are followed up at 24 hours and 1 week.

Arms: arm 1: Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
Interventions: intervention 1: 68Ga-DOTA-Bombesin intervention 2: Magnetic Resonance Imaging (MRI) scan intervention 3: Positron Emission Tomography (PET) scan
Intervention descriptions: intervention 1: 68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is \[4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl\]-acetyl.

68Ga-DOTA-Bombesin is administered intravenously (IV) intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00744497
Conditions: Prostatic Neoplasms
Sponsor: Bristol-Myers Squibb
Start date: 2008-10-01; Completion date: 2015-07-01
Enrollment: 1930 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.

Detailed description:

Arms: arm 1: Participants received placebo, given orally once daily, plus docetaxel, 75 mg/m\^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily arm 2: Participants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m\^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
Interventions: intervention 1: Placebo intervention 2: Dasatinib intervention 3: Docetaxel intervention 4: Prednisone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00760877
Conditions: CHRONIC MYELOGENOUS LEUKEMIA
Keywords: MYELOGENOUS LEUKEMIA Chronic Phase CML
Sponsor: Novartis Pharmaceuticals
Start date: 2009-06-01; Completion date: 2015-07-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of this study was to determine the rate of confirmed best cumulative complete molecular response (CMR) within the first year of study therapy with imatinib or nilotinib. The study also explored the impact and significance of the achieved CMR on patient outcomes (progression free survival (PFS), event free survival (EFS) and overall survival (OS), characterized the kinetics of CMR achieved in both treatment arms and after the cross-over.

Detailed description:

Arms: arm 1: Participants received Nilotinib 400 mg orally twice daily (bid) for 48 months. arm 2: Participants received Imatinib 400 mg or 600 mg once daily (qd) (based on the participant's dose prior to randomization) for 48 months.
Interventions: intervention 1: Nilotinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Supplied in 200 mg capsules intervention 2: Supplied in 100 mg and 400 mg capsules

Protocol documents: