ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01804842
Conditions: Type 2 Diabetes Mellitus
Sponsor: Elcelyx Therapeutics, Inc.
Start date: 2012-12-01; Completion date: 2013-04-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study compared the effects of delayed-release metformin (Met DR, EFB0027) administered once daily in the morning (qAM), administered once daily in the evening (qPM), and administered twice daily (BID) on circulating glucose concentrations and metformin pharmacokinetics (PK) in subjects with type 2 diabetes mellitus (T2DM).

Detailed description:

Arms: arm 1: Two doses of 500 mg metformin delayed-release arm 2: One dose of 1000 mg metformin delayed-release in the morning arm 3: One dose of 1000 mg metformin delayed-release in the evening
Interventions: intervention 1: Met DR
Intervention descriptions: intervention 1: metformin delayed-release tablets

Protocol documents:
Clinical trial NCT01843920
Conditions: Scleral Buckling
Keywords: eye pneumatic retinopexy topical
Sponsor: Jason Hsu, MD
Start date: 2011-06-01; Completion date: 2013-04-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A controlled clinical study comparing the effect of topical aqueous suppressants on intraocular gas duration.

Detailed description:
A Prospective, Randomized Study Comparing the Effects of Topical Aqueous Suppressants on Intraocular Gas Duration following Scleral Buckling and Pneumatic Retinopexy

Arms: arm 1: This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops. arm 2: This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.
Interventions: intervention 1: Timolol-dorzolamide (Glaucoma drops) intervention 2: standard post-operative topical drops
Intervention descriptions: intervention 1: Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group. intervention 2: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim

Protocol documents:
Clinical trial NCT01890343
Conditions: Alzheimer's Disease Frontotemporal Dementia
Sponsor: Avid Radiopharmaceuticals
Start date: 2009-09-01; Completion date: 2013-04-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal volunteers and subjects with Alzheimer's disease (AD).

Detailed description:

Arms: arm 1: Subjects with frontotemporal disorder (FTD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F and a one-time IV bolus injection of 185 MBq of 18F-FDG. arm 2: Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. arm 3: Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
Interventions: intervention 1: florbetapir 18F intervention 2: 18F-FDG
Intervention descriptions: intervention 1: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F. intervention 2: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

Protocol documents:
Clinical trial NCT01901575
Conditions: Tachycardia, Ventricular
Keywords: idiopathic ventricular tachycardia
Sponsor: NYU Langone Health
Start date: 2011-07-01; Completion date: 2013-04-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Determine effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent premature ventricular contractions (PVCs) of non-ischemic origin

Detailed description:
The purpose of the study is to determine the effects of remifentanil conscious sedation in patients undergoing Electrophysiological (EP) studies for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Remifentanil is an analgesic- synthetic opiate with an very short half life. It is rapidly broken down by enzymes in the blood and is ideally suited for continuous sedation. The effect is practically eliminated within 5 minutes after the intravenous sedation is stopped.

You are being asked to participate in this study because you are already scheduled to undergo EP studies under the care of your cardiologist for the ablation of idiopathic ventricular tachycardia and/or persistent frequent PVCs of non-ischemic origin.

Arms: arm 1: patients with PVC's prior to administration of remifentanil
Interventions: intervention 1: Remifentanil
Intervention descriptions: intervention 1: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol

Protocol documents:
Clinical trial NCT01912352
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD ADRA2A Methylphenidate Response
Sponsor: Seoul National University
Start date: 2010-05-01; Completion date: 2013-04-01
Enrollment: 83 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aims of the current study are to examine gene-environment interactions associated with norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic changes in norepinephrine pathway are associated with differences in functional connectivity of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore, this study aims to examine neurobiological markers, such as intermediate neuroimaging phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD. Through evaluating drug responses and side effects with the associated measures of clinical, neuropsychological and neuroimaging characteristics, investigators would like to investigate predictors of treatment response associated with NE system genes in ADHD.

Detailed description:

Arms: arm 1: Participants were treated with methylphenidate (ranging from to 63mg) for 8 weeks. Doses of methylphenidate were titrated depending on symptoms and adverse eff ects at the 2nd and 4th weeks of treatment.
Interventions: intervention 1: Methylphenidate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02006342
Conditions: Diabetic Ketoacidosis
Keywords: Diabetes Mellitus Diabetic Ketoacidosis Insulin Glargine Anion gap Metabolic acidosis
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2012-11-01; Completion date: 2013-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA).

Detailed description:

Arms: arm 1: Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis. arm 2: Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.
Interventions: intervention 1: Insulin Glargine intervention 2: Regular Insulin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02778100
Conditions: Common Cold
Sponsor: Eli Lilly and Company
Start date: 2013-03-01; Completion date: 2013-04-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to evaluate the safety of nasal glucagon (NG) in participants with a common cold, some of whom will also take a nasal decongestant. The study will investigate how the body processes NG and the effect of NG on the body. The study will last up to 30 days for each participant.

Detailed description:

Arms: arm 1: Cohort 1 - Nasal Glucagon (NG) administered once in participants with a common cold. arm 2: Cohort 1 - NG administered once in participants who have recovered from a common cold. arm 3: Cohort 2 - NG administered once in participants with a common cold who are taking oxymetazoline.
Interventions: intervention 1: Nasal Glucagon intervention 2: Oxymetazoline
Intervention descriptions: intervention 1: Administered intranasally. intervention 2: Administered intranasally.

Protocol documents:
Clinical trial NCT01405963
Conditions: Asthma
Keywords: Amgen AMG 157 Asthma
Sponsor: Amgen
Start date: 2011-10-31; Completion date: 2013-04-05
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the late and early asthmatic response after an allergen inhalation challenge in adults with mild atopic asthma after receiving multiple doses of tezepelumab (AMG 157), as well as the safety, tolerability, immunogenicity, and pharmacokinetics of multiple doses of tezepelumab in adults with mild atopic asthma.

Detailed description:

Arms: arm 1: Participants received placebo to tezepelumab administered by intravenous infusion on study days 1, 29, and 57. arm 2: Participants received 700 mg tezepelumab administered by intravenous infusion on study days 1, 29, and 57.
Interventions: intervention 1: Placebo intervention 2: Tezepelumab
Intervention descriptions: intervention 1: Administered in a 1-hour intravenous infusion intervention 2: Administered in a 1-hour intravenous infusion

Protocol documents:
Clinical trial NCT01478828
Conditions: Prostate Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2012-07-13; Completion date: 2013-04-08
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the dose of continuous daily oral lovastatin needed to achieve MYC \[v-myc myelocytomatosis viral oncogene homolog (avian)\] down-regulation in prostatectomy specimens in intermediate-/high-risk localized prostate cancer patients.

Detailed description:
Pharmacodynamic Phase 0 trial of pre-prostatectomy lovastatin to downregulate MYC in localized prostate cancer.

Rationale: Based on available clinical and preclinical data, the investigators theorize that high-dose lovastatin therapy will decrease MYC levels in human prostate cancers shown to have MYC overexpression on biopsy.

Experimental Methods: The investigators propose a prospective, dose-finding pharmacodynamic study of lovastatin in intermediate/high-grade localized prostate cancer. The study will involve 30 eligible patients with localized prostate cancer with a Gleason sum of 7 to 10 who elect to undergo prostatectomy at Johns Hopkins. Five eligible men will be scheduled to receive oral lovastatin following a four times a day schedule, at the starting dose of 12 mg/kg/day. Patients will receive 2 weeks (14 days) of daily oral lovastatin prior to surgery. Following an initial safety monitoring period of a month, the investigators enroll at the next dose level (20 mg/kg/day). Similar dose de-escalation will continue over three more dose levels (1, 4 and 8 mg/kg/day) until 25 patients total are enrolled. Following surgery, prostatectomy specimens will undergo MYC immunohistochemistry (IHC) and compared to MYC IHC from matched biopsy samples. Pharmacodynamic efficacy (PE) will be defined as greater than 60% inhibition of MYC expression by IHC in greater than 60% of patients in prostatectomy tumor specimens compared to the matched biopsy.

Expected Results: The investigators expect lovastatin will enforce the downregulation of MYC levels in prostatectomy samples as compared to pre-lovastatin treatment core biopsy samples. The investigators also expect little toxicity to patients as reported in prior phase I and II trials using similar doses of lovastatin.

Arms: arm 1: After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
Interventions: intervention 1: Lovastatin
Intervention descriptions: intervention 1: oral qd varying dose escalations/de-escalations

Protocol documents:
Clinical trial NCT00844649
Conditions: Metastatic Pancreatic Cancer
Sponsor: Celgene
Start date: 2009-03-01; Completion date: 2013-04-09
Enrollment: 861 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase III Metastatic Pancreatic Cancer

Detailed description:
A Phase III, open-label randomized, multicenter trial to compare ABI-007(Albumin-bound Paclitaxel)in combination with gemcitabine administered weekly to standard treatment (gemcitabine monotherapy) with respect to overall survival, objective tumor response rate and Progression Free Survival (PFS) in patients diagnosed with metastatic adenocarcinoma of the pancreas.

Arms: arm 1: ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by one week of rest. arm 2: Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).
Interventions: intervention 1: Albumin-bound paclitaxel (ABI-007) intervention 2: Gemcitabine
Intervention descriptions: intervention 1: ABI-007 125 mg/m\^2 administered by intravenous infusion intervention 2: Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward).

Protocol documents:
Clinical trial NCT01498952
Conditions: Unresectable or Metastatic Hepatocellular Carcinoma (HCC)
Keywords: HCC, liver cancer, hepatocellular carcinoma, MEDI-573, anti-IGF
Sponsor: MedImmune LLC
Start date: 2012-01-17; Completion date: 2013-04-09
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 1b/2, open-label, randomized study to evaluate MEDI-573 in combination with standard of care in adult subjects with unresectable or metastatic hepatocellular carcinoma (HCC).

Detailed description:

Arms: arm 1: Participants will receive MEDI-573 10 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. arm 2: Participants will receive MEDI-573 45 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. arm 3: Participants will receive MEDI-573 30 mg/kg intravenous infusion on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. arm 4: Participants will receive recommended dose of MEDI-573 from Phase 1b IV on Day 1 of each 21-day cycle and sorafenib 400 mg orally twice daily as background therapy until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons. arm 5: Participants will receive sorafenib 400 mg orally twice daily until unacceptable toxicity, documentation of disease progression, initiation of alternative anticancer treatment, or withdrawal for other reasons.
Interventions: intervention 1: MEDI-573 (1 of 3 doses) intervention 2: Sorafenib
Intervention descriptions: intervention 1: MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands intervention 2: Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor

Protocol documents:
Clinical trial NCT00849667
Conditions: Ovarian Cancer
Keywords: ovarian cancer relapsed ovarian cancer Platinum-sensitive Ovarian Cancer
Sponsor: Morphotek
Start date: 2009-04-16; Completion date: 2013-04-12
Enrollment: 1100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.

Detailed description:

Arms: arm 1: Participants will receive farletuzumab 1.25 milligram per kilogram (mg/kg) administer as an intravenous (IV) infusion weekly, followed by taxane (paclitaxel \[175 milligram per meter square {mg/m\^2}\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain area under curve \[AUC\] 5-6 milligram per milliliter per minute \[mg/mL/minute\]), administer as IV infusion, every three weeks, on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 1.25 mg/kg, administer as IV infusion, weekly is given until disease progression. arm 2: Participants will receive farletuzumab 2.5 mg/kg administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab 2.5 mg/kg, administer as IV infusion, weekly is given until disease progression. arm 3: Participants will receive farletuzumab-matched placebo (0.9 percent \[%\] saline) administer as an IV infusion weekly, followed by taxane (paclitaxel \[175 mg/m\^2\] or docetaxel \[75 mg/m\^2\]), administer as IV infusion and followed by carboplatin (to maintain AUC 5-6 mg/mL/minute), administer as IV infusion, every three weeks on Day 1 of each 21-day cycle for 6 cycles (combination therapy). Following completion of combination therapy, maintenance treatment with farletuzumab-matched placebo (0.9% saline), administer as IV infusion, weekly is given until disease progression.
Interventions: intervention 1: Farletuzumab intervention 2: Carboplatin intervention 3: Taxane intervention 4: Farletuzumab-matched placebo
Intervention descriptions: intervention 1: Farletuzumab IV infusion. intervention 2: Carboplatin IV infusion. intervention 3: Taxane (Paclitaxel or Docetaxel) IV infusion. intervention 4: Farletuzumab-matched placebo IV infusion.

Protocol documents:
Clinical trial NCT01786876
Conditions: Healthy Volunteers
Keywords: Radiolabelled AME
Sponsor: Shire
Start date: 2013-03-07; Completion date: 2013-04-12
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14C\] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Radiolabeled SPD557
Intervention descriptions: intervention 1: A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1

Protocol documents:
Clinical trial NCT01413750
Conditions: Stage IIIA Lung Non-Small Cell Cancer AJCC v7 Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Stage IV Lung Non-Small Cell Cancer AJCC v7
Sponsor: National Cancer Institute (NCI)
Start date: 2010-11-08; Completion date: 2013-04-14
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving carboplatin and paclitaxel together is more effective with or without vorinostat in treating non-small cell lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To compare progression-free survival associated with the combination of carboplatin, paclitaxel and vorinostat versus carboplatin, paclitaxel and placebo for patients with previously untreated, advanced NSCLC.

SECONDARY OBJECTIVES:

I. To determine the response rate, time to treatment failure, and overall survival for the two regimens.

II. To assess the safety profile of the regimen of vorinostat, carboplatin and paclitaxel for patients with advanced NSCLC.

III. To understand the mechanistic aspects of drug effect by conducting correlative science studies on peripheral blood and archived tumor tissue.

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

ARM I: Patients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on day 0. Patients also receive vorinostat orally (PO) once daily on days -2 to 2.

ARM II: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive placebo PO once daily on days -2 to 2.

In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, quarterly for 1 year, and then twice a year thereafter.

Arms: arm 1: Patients receive paclitaxel IV over 3 hours, and carboplatin IV over 30 minutes on day 0. Patients also receive vorinostat PO once daily on days -2 to 2. arm 2: Patients receive paclitaxel and carboplatin as in arm I. Patients also receive placebo PO once daily on days -2 to 2.
Interventions: intervention 1: Carboplatin intervention 2: Laboratory Biomarker Analysis intervention 3: Paclitaxel intervention 4: Placebo Administration intervention 5: Vorinostat
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies intervention 3: Given IV intervention 4: Given PO intervention 5: Given PO

Protocol documents: