ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01397448
Conditions: Gastric or Duodenal Ulcers Caused by Low-dose Aspirin
Keywords: Rabeprazole proton pump inhibitor Acetylsalicylic Acid Aspirin Gastric Ulcer Duodenal Ulcer
Sponsor: Eisai Co., Ltd.
Start date: 2011-07-01; Completion date: 2013-06-01
Enrollment: 472 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810 over Teprenone.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: E3810 intervention 2: E3810 intervention 3: Teprenone
Intervention descriptions: intervention 1: E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal. intervention 2: E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal. intervention 3: Teprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal.

Protocol documents:
Clinical trial NCT01397890
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Severe chronic obstructive pulmonary disease (COPD) patients
Sponsor: AstraZeneca
Start date: 2011-07-01; Completion date: 2013-06-01
Enrollment: 793 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicentre study with a randomised, parallel group, open-label, 3-month phase IV design to assess the efficacy and tolerability of Symbicort as an add-on treatment to Spiriva compare with Spiriva alone in patients with severe chronic obstructive pulmonary disease (COPD).

Detailed description:

Arms: arm 1: Add-on treatment arm 2: Add-on treatment
Interventions: intervention 1: Budesonide/formoterol (Symbicort® Turbuhaler®) intervention 2: Tiotropium (SpirivaTM)
Intervention descriptions: intervention 1: Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily intervention 2: Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily

Protocol documents:
Clinical trial NCT01404611
Conditions: Acute Otitis Media
Keywords: with tubes
Sponsor: Salvat
Start date: 2011-06-01; Completion date: 2013-06-01
Enrollment: 331 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.

Detailed description:

Arms: arm 1: Ear drops arm 2: Ear drops arm 3: Ear drops
Interventions: intervention 1: DF289 intervention 2: DF277 intervention 3: DF289 plus DF277
Intervention descriptions: intervention 1: Ear drops intervention 2: Ear drops intervention 3: Ear drops

Protocol documents:
Clinical trial NCT01415401
Conditions: Glaucoma Ocular Hypertension Open-angle Glaucoma
Keywords: Glaucoma Ocular hypertension Intraocular pressure (IOP) Open angle glaucoma Pigment dispersion glaucoma Pigmentary
Sponsor: Alcon Research
Start date: 2011-09-01; Completion date: 2013-06-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).

Detailed description:

Arms: arm 1: Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
Interventions: intervention 1: Brinzolamide 1% / timolol 0.5% maleate fixed combination
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01426269
Conditions: Rosacea
Sponsor: Galderma R&D
Start date: 2011-09-01; Completion date: 2013-06-01
Enrollment: 235 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess relapse, efficacy and safety in subjects with rosacea during long-term treatment with either Oracea® or placebo, after an initial 12-week regimen of Oracea® and MetroGel® 1%.

Detailed description:
Adult subjects with moderate to severe papulopustular rosacea will receive Oracea® and MetroGel® 1% once daily during phase 1 (baseline to week 12) of the study. Subjects will be eligible to enter phase 2 of the study based upon improvements in the Investigator's Global Assessment (IGA) score. During phase 2, subjects will receive either Oracea® or placebo once daily for up to an additional 40 weeks. Subjects who relapse during phase 2 will be discontinued from the study.

Arms: arm 1: Subjects will receive placebo during phase 2 (week 12 - week 52) arm 2: Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12) arm 3: Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)
Interventions: intervention 1: Doxycycline intervention 2: Metronidazole intervention 3: Placebo
Intervention descriptions: intervention 1: During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release \& 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release \& 10 mg delayed release beads), oral, one capsule daily in the morning intervention 2: During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area intervention 3: During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning

Protocol documents:
Clinical trial NCT01426373
Conditions: Moderate or Severe Submental Fullness
Sponsor: Kythera Biopharmaceuticals
Start date: 2011-08-01; Completion date: 2013-06-01
Enrollment: 165 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).

Detailed description:

Arms: arm 1: Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
Interventions: intervention 1: Deoxycholic acid injection
Intervention descriptions: intervention 1: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

Protocol documents:
Clinical trial NCT01426412
Conditions: Hyperlipidemia
Sponsor: Eli Lilly and Company
Start date: 2011-09-01; Completion date: 2013-06-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study in otherwise healthy Japanese and non-Japanese participants with elevated low density lipoprotein cholesterol (LDL-C). Following single doses of LY3015014, the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body will be evaluated. Participants will remain in the study for approximately up to 6 months.

Detailed description:

Arms: arm 1: A single dose of LY3015014 up to 10.0 milligrams per kilogram (mg/kg) administered IV arm 2: Single dose of LY3015014 10.0 mg/kg administered IV to Japanese participants. Added per protocol amendment effective October, 2012. arm 3: Administered IV once only arm 4: A single dose of LY3015014 up to 3.0 mg/kg administered SC arm 5: A single dose of LY3015014 up to 3 mg/kg administered SC in addition to participant's dose of statin arm 6: Administered SC once only
Interventions: intervention 1: LY3015014 IV intervention 2: Placebo IV intervention 3: LY3015014 SC intervention 4: Placebo SC
Intervention descriptions: intervention 1: Administered IV over 30-90 minutes intervention 2: Administered IV only over 30-90 minutes intervention 3: Administered SC intervention 4: Administered SC

Protocol documents:
Clinical trial NCT01436045
Conditions: Alzheimer's Disease
Keywords: Memory Insulin glulisine Alzheimer's Disease
Sponsor: HealthPartners Institute
Start date: 2011-09-01; Completion date: 2013-06-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate the effect of the rapidly acting intranasal insulin derivative (glulisine) on memory and cognition in 12 patients suffering from mild-moderate Alzheimer's Disease (AD) using a double-blind placebo-controlled single dose study. This study will further assess safety of insulin glulisine as well as the effects of this drug on olfaction.

Detailed description:
A single center, phase II randomized, double-blind, placebo-controlled, cross-over study designed to assess the efficacy and safety of intranasally (IN) delivered insulin glulisine versus placebo in patients aged 65-85 with mild-moderate Alzheimer's Disease (AD). Twelve AD subjects (six female and six male) will be randomized to receive a single dose of either 20 IU/IN insulin glulisine or placebo using the MAD 300 device.

Arms: arm 1: A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits. arm 2: A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.
Interventions: intervention 1: Insulin glulisine intervention 2: Saline
Intervention descriptions: intervention 1: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril) intervention 2: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)

Protocol documents:
Clinical trial NCT01436084
Conditions: Leukemia
Keywords: Leukemia Myelodysplastic syndrome MDS SB1518
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-12-01; Completion date: 2013-06-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if SB1518 can help to control myelodysplastic syndrome. The safety of the drug will also be studied.

SB1518 is designed to block JAK2 and FLT3. SB1518 may have anti-tumor activity in certain leukemias, myelofibrosis, and lymphoma.

Detailed description:
Study Drug Administration:

If you are found to be eligible to take part in this study, you will take SB1518 by mouth 1 time every day. You can take it with or without food, and it should be taken at the same time every day.

You will receive your monthly supply of SB1518 during your clinic visit. The capsules should not be opened or crushed. Do not touch the powder in the capsules. If you do, wash effected areas thoroughly with water.

Each study cycle is 28 days.

Study Visits:

At every study visit, you will be asked about any drugs you may be taking, and any side effects you have had.

One (1) time a week during Cycle 1, blood (about 2 tablespoons) will be drawn for routine tests.

On Day 1 of Cycles 2 and beyond, blood (about 2 tablespoons) will be collected for routine tests.

On Day 28 of each cycle, you will have a bone marrow aspirate and/or biopsy to check the status of the disease. If the screening bone marrow test showed unusual genetic test results, these samples will be used for cytogenetic testing. If you have a response to therapy, you will have a bone marrow aspirate and/or biopsy every 3 cycles, if your doctor thinks it needed.

Length of Study:

You may continue taking the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, you are able to undergo allogeneic bone marrow transplantation, or if you are unable to follow study directions.

Your participation on the study will be over once you have completed the end-of-treatment visit.

End-of-Treatment Visit:

At 30 days after your last dose of study drug, you will have an end-of-treatment visit.

* You will be asked about any drugs you may be taking, and any side effects you have had.
* Blood (about 2 tablespoons) will be drawn for routine tests.
* You will have a bone marrow aspirate and/or biopsy to check the status of the disease, if your doctor thinks it is needed.

This is an investigational study. SB1518 is not FDA approved or commercially available. It is currently being used for research purposes only.

Up to 40 participants will take part in this study. All will be enrolled at MD Anderson.

Arms: arm 1: 400 mg orally a day for 28 day cycle.
Interventions: intervention 1: SB1518
Intervention descriptions: intervention 1: 400 mg taken orally, once daily without regard of food, 28 day cycle.

Protocol documents:
Clinical trial NCT01445951
Conditions: Type 1 Diabetes Mellitus
Sponsor: Mannkind Corporation
Start date: 2011-09-01; Completion date: 2013-06-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin

Detailed description:
Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects.

Arms: arm 1: Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry arm 2: Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry arm 3: Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry
Interventions: intervention 1: Technosphere® Insulin with MedTone C Inhaler intervention 2: Technosphere ®Insulin with Gen2 Inhaler intervention 3: Insulin Aspart in combination with a basal insulin
Intervention descriptions: intervention 1: Inhalation Powder and injectable insulin intervention 2: Inhalation Powder and injectable insulin intervention 3: Injectable insulin

Protocol documents:
Clinical trial NCT01449539
Conditions: Multiple Myeloma
Keywords: Hyperbaric oxygen mobilize stem cells growth factor
Sponsor: University of Arkansas
Start date: 2012-02-01; Completion date: 2013-06-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of hyperbaric oxygen therapy (HBOT) as a therapeutic option in mobilizing stem cells for autologous stem cell transplant.

Detailed description:
Subjects will receive HBOT daily for 10 days in conjunction with standard growth factor treatment regimens for stem cell mobilization. The role of HBOT in stem cell mobilization as well as its role on oxidative stress will be evaluated.

Interventions: intervention 1: Hyperbaric Oxygen Therapy
Intervention descriptions: intervention 1: Treatment Monday through Friday in a monoplace hyoerbaric chamber 100% oxygen at 2.0 atmospheres (14.7 PSI or the equivalent of being under 33 feet of sea water) for 90 minutes at pressure. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each subject will be treated for two weeks for a total of 10 HBOT treatments

Protocol documents:
Clinical trial NCT01452347
Conditions: Heart Valve Diseases
Sponsor: Boehringer Ingelheim
Start date: 2011-10-01; Completion date: 2013-06-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Detailed description:

Arms: arm 1: Patient dose dependent on screening CrCl levels and TT arm 2: warfarin doses to maintain INR levels
Interventions: intervention 1: warfarin 1mg intervention 2: dabigatran etexilate intermediate dose intervention 3: dabigatran etexilate low dose intervention 4: warfarin 5mg intervention 5: dabigatran etexilate high dose intervention 6: warfarin 3mg
Intervention descriptions: intervention 1: comparator warfarin intervention 2: active treatment (medium) intervention 3: active treatment (low) intervention 4: comparator warfarin intervention 5: active treatment (high) intervention 6: comparator warfarin

Protocol documents:
Clinical trial NCT01457950
Conditions: Osteoporosis, Postmenopausal
Keywords: denosumab Republic of Korea dual energy x-ray absorptiometry
Sponsor: GlaxoSmithKline
Start date: 2011-11-01; Completion date: 2013-06-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if denosumab is effective in increasing bone mineral density at the lumbar spine in Korean postmenopausal women with osteoporosis.

Detailed description:

Arms: arm 1: denosumab 60mg subcutaneous injection, single dose at the start of the 6-month double-blind phase arm 2: placebo subcutaneous injection, single dose at the start of the 6-month double-blind phase arm 3: open-label phase follows the double-blind phase, denosumab 60mg subcutaneous injection, single dose at the start of the 6-month open-label phase
Interventions: intervention 1: denosumab intervention 2: placebo intervention 3: open-label denosumab
Intervention descriptions: intervention 1: double-blind phase: 60mg subcutaneous injection, single dose intervention 2: double-blind phase: placebo subcutaneous injection, single dose intervention 3: open-label phase: 60mg subcutaneous injection, single dose

Protocol documents:
Clinical trial NCT01459796
Conditions: Gout
Sponsor: Regeneron Pharmaceuticals
Start date: 2011-11-01; Completion date: 2013-06-01
Enrollment: 220 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51. arm 2: Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
Interventions: intervention 1: Rilonacept intervention 2: Placebo intervention 3: Allopurinol
Intervention descriptions: intervention 1: Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks. intervention 2: Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks. intervention 3: Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.

Protocol documents:
Clinical trial NCT01464593
Conditions: Colon Cancer Liver Metastasis
Keywords: Colorectal Liver Metastasis Colon Cancer Liver Cancer Liver Metastasis Liver metastases
Sponsor: Imunon
Start date: 2011-09-01; Completion date: 2013-06-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety and efficacy of Thermodox, a thermally sensitive liposomal doxorubicin, in combination with thermal ablation in the treatment of hepatic colorectal liver metastases (CRLM).

Detailed description:
This is an open label phase II trial to evaluate the safety, feasibility, and efficacy of ThermoDox in combination wtih thermal ablation for the regional hepatic treatment of mCRC liver lesions.

Eligible colorectal cancer patients will unresectable liver metastases and be candidate for either radiofrequency ablation (RFA) or microwave ablation (MWA). All unresectable lesions must be targeted for ablation in in nor more than 2 thermal ablation/ThermoDox procedures.

Approximately 24 hours prior to treatment with ThermoDox, patients will start a regimen of prophylaxis (detailed in the Study Drug section below) against immediate hypersensitivity reactions.

Treatment will begin with a 50 mg/m2 ThermoDox infusion administered intravenously (IV) over 30 minutes. Thermal Ablation will be initiated a minimum of 15 minutes after start of the infusion and should be completed no later than 3 hours after starting the infusion. Subjects will have follow up visits on Day 14 and at months 1, 4, 7, 10,13, 16, 19, 22, and 25 (+ 7 days) or until study discontinuation.

At baseline and at each post-treatment clinic visit, patients will self-report their "quality of life" (QoL) using the 8-item FACT-Hepatobiliary Symptom Index (FHSI-8).

Contrast CT imaging studies or Magnetic Resonance Imaging (MRI)will be used to assess the effectiveness of therapy. CT or MRI scans will be obtained at baseline and at months 1, 4, 7, 10, 13, 16, 19, 22, and 25(+ 7 days)until local recurrence is seen, the subject has discontinued, or 2 years of follow-up have elapsed, whichever occurs first. All protocol-specified CT/MRI images will be centrally read by an independent radiology assessor.

Subjects will be followed for each efficacy endpoint local tumor control through 2 years after treatment. Secondary endpoints including Overall Survival, Time to Local Recurrence, PRO deterioration) will be evaluated until the event occurs, the subject is discontinued, or until 3 years following treatment.

Arms: arm 1: Thermodox 50 mg/m2 intravenous infusion over 30 minutes starting 15 minutes before thermal ablation.
Interventions: intervention 1: Lyso-Thermosensitive Liposomal Doxorubicin intervention 2: 5% Dextrose Solution intervention 3: ThermoDox
Intervention descriptions: intervention 1: Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion. intervention 2: Single 30 minute intravenous infusion intervention 3: ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.

Protocol documents: