ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01233999
Conditions: Raynaud's Syndrome
Keywords: Scleroderma Raynaud's Syndrome
Sponsor: Emory University
Start date: 2010-10-01; Completion date: 2012-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators are studying a medical condition known as Raynaud's Phenomenon (RP). RP is a painful condition in which cold surroundings or stressful events trigger pain, a cold sensation, and in severe cases, sores and ulcers on one's fingers. The investigators think that RP results from problems with some of the components of the blood vessels, surrounding nerves, and some of the circulating messengers in the bloodstream. Although there are many different medicines that are currently used to treat RP, the investigators have not yet found a cure for severe cases of this condition. Furthermore, the investigators have found few medicines that show consistent healing of the ulcers that may be associated with RP. Some of the treatments include medicines that are used to treat high blood pressure known as calcium channel blockers. Medications that thin the blood (anticoagulants) such as aspirin have also been used to treat RP.

In this study, the investigators will investigate a new treatment for RP known as Botulinum toxin A. Botulinum toxin is a chemical that is temporarily toxic to nerves, but has been approved by the government for the treatment of several other conditions including but not limited to: excessive sweating, neck pain associated with a condition known as cervical dystonia, uncontrollable forcible closure of the eyelids known as blepharospasm, and a condition known as strabismus in which the eyes are not in alignment with one another.

This study will aim to greatly improve the quality of life and pain associated with RP. Previous studies also support the chance that Botulinum toxin will help to heal some of the ulcers associated with RP. Although there is no current standard of care, many of the patients in the study will have already failed or are unable to tolerate commonly used treatments such as lifestyle modifications, calcium channel blockers, nitroglycerin, and anticoagulants. If the patient chooses to participate in the study, he/she will be randomly assigned to receive an injection with Botulinum toxin in either the left or right hand. The other hand will be injected with saline solution. Neither the patient nor the physician or research personnel seen in follow-up will know which hand is injected with Botulinum toxin.

Detailed description:

Arms: arm 1: single-drug dosage comparison cross-over study
Interventions: intervention 1: botulinum toxin A
Intervention descriptions: intervention 1: Botulinum toxin A will be injected into participants hand total 40units

Protocol documents:
Clinical trial NCT01239030
Conditions: Attention Deficit Hyperactivity Disorder ADHD
Keywords: inattention impulsivity hyperactivity ADHD
Sponsor: Rhodes Pharmaceuticals, L.P.
Start date: 2010-11-01; Completion date: 2012-03-01
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center parallel study is designed to study the efficacy and safety of fixed doses of methylphenidate extended release (ER) capsules of four dose levels compared with a placebo group in pediatric patients with Attention Deficit Hyperactivity Disorder (ADHD) who are between 6 and 18 years old.

Detailed description:
This is a parallel, randomized, double-blind, multi-center, placebo-controlled, forced dose, phase 3 study to evaluate the safety and efficacy of Biphentin® methylphenidate hydrochloride (HCl) extended release (ER) capsules in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric and adolescent patients aged 6 up to 18 years.

The primary objective was to assess the efficacy of Biphentin compared to placebo, in the clinic setting, as measured by the clinician-administered parent version of the ADHD-RS-IV.

Subjects who met study entry criteria were enrolled in the Double-blind Phase and were randomized to either a fixed dose of Biphentin (!0, 15, 20, or 40 mg/day) or placebo capsule taken daily in the morning for 1 week. Subjects then continued into an Open-label Phase that included dose optimization with doses starting at 10 mg and allowed up to 60 mg. The open-label period following the one double-blind fixed dose week provides additional opportunity for subjects to receive treatment with Biphentin. Extra unscheduled dose optimization visits are allowed as needed for additional dose titration visits during the open-label period.

The safety and tolerability, and efficacy assessments will be conducted throughout the study.

Biphentin® is designed to be a single daily dose alternative to separate doses of immediate release methylphenidate by providing a biphasic plasma profile. It achieves a first Cmax more similar to immediate release methylphenidate.

Arms: arm 1: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 10 mg arm 2: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 15 mg arm 3: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 20 mg arm 4: Biphentin Methylphenidate Hydrochloride Extended Release Capsules 40 mg arm 5: Placebo capsules arm 6: Biphentin Methylphenidate Hydrochloride Extended Release Capsules (10, 15, 20, 40, 50 or 60 mg) - Open Label Phase
Interventions: intervention 1: Methylphenidate Hydrochloride Extended Release Capsules intervention 2: Placebo
Intervention descriptions: intervention 1: Biphentin Methylphenidate ER Once-A-Day Capsules intervention 2: Placebo capsules

Protocol documents:
Clinical trial NCT01241448
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Start date: 2011-01-01; Completion date: 2012-03-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
LY2409021 is being evaluated for possible treatment in type 2 diabetes. This study is designed to compare LY2409021 given alone or given in combination with metformin against placebo the change in hemoglobin A1c after a 24-week treatment period.

Detailed description:

Arms: arm 1: Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. arm 2: Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. arm 3: Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician. arm 4: Taken orally once daily for 24 weeks. Participants who entered the study on stable metformin therapy were to continue at the dose prescribed by their physician.
Interventions: intervention 1: LY2409021 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered Orally intervention 2: Administered Orally

Protocol documents:
Clinical trial NCT01248793
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing Sponylitis, injection, golimumab, simponi
Sponsor: Centocor, Inc.
Start date: 2010-10-01; Completion date: 2012-03-01
Enrollment: 213 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of golimumab in Chinese patients with ankylosing spondylitis

Detailed description:
Golimumab is a type of tumor necrosis factor (TNF) inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease by blocking the activity of TNF in the body and reducing inflammation and pain. Each patient who is allowed to join the study will be put into a group randomly, like flipping a coin. Patients may get either golimumab or placebo (which looks like the drug being studied but has no active ingredients, for example a sugar pill). The chance that the patient will get golimumab is 1 to 1, so 50% chance to receive golimumab and 50% change to receive placebo. Patients who do not have an improvement in total back pain and morning stiffness at the Week 16 visit compared to when the patients entered the study, and are in Group 1 (placebo group), will receive golimumab 50 mg every 4 weeks starting at Week 16. If the patient is in Group 2 (golimumab 50 mg), they will continue to receive golimumab every 4 weeks starting at Week 16. If the patient is in Group 1 and still receiving placebo injections, because there was improvement in total back pain at Week 16, they will receive golimumab 50 mg every 4 weeks starting from Week 24. If the patient is in Group 2 (golimumab 50 mg) or are already receiving golimumab injections at week 24, they will continue to receive golimumab every 4 weeks. Safety will be monitored throughout the study, including drawing blood and looking at laboratory tests, vital signs (eg, blood pressure), and the frequency and type of adverse events (side effects). The patient will be in the study approximately 56 weeks. Patients will receive placebo or active compound (golimumab 50 mg subcutaneous injections) every four weeks until Week 48.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Placebo intervention 2: Golimumab intervention 3: Golimumab (placebo group)
Intervention descriptions: intervention 1: Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20 intervention 2: Golimumab 50 mg SC injection every 4 weeks for 48 weeks intervention 3: Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48

Protocol documents:
Clinical trial NCT01268111
Conditions: Insulin Sensitivity
Keywords: vitamin D deficiency, insulin sensitivity
Sponsor: Texas Tech University Health Sciences Center
Start date: 2011-01-01; Completion date: 2012-03-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Healthy subjects with low Vitamin D levels will be randomly assigned to either Vitamin D replacement or placebo for a period of 8 weeks. Insulin sensitivity will be measured before and after the intervention, and the changes will be compared between the two groups. This will help us understand if Vitamin D replacement improves insulin sensitivity. Serum Retinol Binding Protein 4 levels will also be measured to see if changes in insulin sensitivity are mediated by RBP4.

Detailed description:

Arms: arm 1: ERgocalcifoerol 50,000 units q weekly for 8 weeks arm 2: None
Interventions: intervention 1: Ergocalciferols intervention 2: Placebo
Intervention descriptions: intervention 1: ERgocaclciferol 50,000 units weekly for 8 weeks intervention 2: matching placebo

Protocol documents:
Clinical trial NCT01276106
Conditions: Type 2 Diabetes Mellitus
Keywords: AC-201 Interleukin 1 inhibitor
Sponsor: TWi Biotechnology, Inc.
Start date: 2011-01-01; Completion date: 2012-03-01
Enrollment: 259 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 24-week randomized placebo-controlled study to investigate the effect of an oral IL-1beta inhibitor AC-201 in patients with type 2 diabetes mellitus already treated on different background diabetes therapies.

Detailed description:

Arms: arm 1: 25mg BID for 24 weeks arm 2: 50mg BID for 24 weeks arm 3: 75mg BID for 24 weeks arm 4: Placebo BID for 24 weeks
Interventions: intervention 1: AC-201, 25mg intervention 2: AC-201, 50mg intervention 3: AC-201, 75mg intervention 4: Placebo
Intervention descriptions: intervention 1: Capsule, 25mg BID intervention 2: Capsule, 50mg BID intervention 3: Capsule, 75mg BID intervention 4: Placebo BID

Protocol documents:
Clinical trial NCT01286740
Conditions: HIV-1 Infection
Keywords: HIV-1 HIV Treatment Experienced
Sponsor: Gilead Sciences
Start date: 2011-01-01; Completion date: 2012-03-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this Phase 2b study was to evaluate the efficacy and safety of the emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) STR, after switching from the efavirenz (EFV)/FTC/TDF STR at baseline, in maintaining HIV-1 RNA \< 50 copies/mL at Week 12. HIV-infected patients were enrolled if they had received EFV/FTC/TDF for ≥ 3 months prior to study start, were experiencing safety or tolerability concerns (in particular, EFV-related intolerance), and wished to change to an alternate, better-tolerated regimen.

Detailed description:

Arms: arm 1: Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Interventions: intervention 1: FTC/RPV/TDF
Intervention descriptions: intervention 1: Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily

Protocol documents:
Clinical trial NCT01294423
Conditions: Type 2 Diabetes High Blood Sugar
Keywords: Phase3 Clinical trial Type2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2011-02-01; Completion date: 2012-03-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 24-week randomised, multi-centre phase III study to evaluate the efficacy and safety of dapagliflozin as monotherapy in Japanese subjects with Type 2 diabetes mellitus who have inadequate glycemic control with diet and exercise.

Detailed description:

Arms: arm 1: Dapagliflozin 5 mg arm 2: Dapagliflozin 10 mg arm 3: None
Interventions: intervention 1: Dapagliflozin intervention 2: Dapagliflozin intervention 3: Placebo
Intervention descriptions: intervention 1: Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose intervention 2: Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose intervention 3: Matching placebo for Dapagliflozin 5mg/10mg oral dose

Protocol documents:
Clinical trial NCT01297517
Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: AOG OHT Open-Angle Glaucoma Ocular Hypertension
Sponsor: Alcon Research
Start date: 2011-02-01; Completion date: 2012-03-01
Enrollment: 1001 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.

Detailed description:
This study consisted of 6 visits conducted during 2 sequential phases: the Screening/Eligibility phase, which included a screening visit and 2 eligibility visits, and the Treatment phase, which included 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.

Arms: arm 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months arm 2: Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months arm 3: Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months
Interventions: intervention 1: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension intervention 2: Brinzolamide ophthalmic suspension, 1% intervention 3: Brimonidine tartrate ophthalmic solution, 0.2%
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01313520
Conditions: Arthritis, Rheumatoid
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-03-01; Completion date: 2012-03-01
Enrollment: 61 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to compare the effect of infliximab versus placebo on synovial inflammation as measured by dynamic contrast enhanced (DCE)-MRI of one wrist. The primary hypothesis is that over 14 weeks of therapy, the change from baseline in the volume transfer rate in enhancing synovium is larger due to treatment with infliximab than with placebo.

Detailed description:

Arms: arm 1: 3 mg/kg of Infliximab intravenous infusion arm 2: saline via intravenous infusion
Interventions: intervention 1: Infliximab intervention 2: Placebo
Intervention descriptions: intervention 1: 3 mg/kg of Infliximab at Weeks 0, 2, 6, 14 via intravenous infusion intervention 2: 250 mL of 0.9% sodium chloride at Weeks 0, 2, 6, 14 via intravenous infusion

Protocol documents:
Clinical trial NCT01315249
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: QVA149 indacaterol NVA237 COPD fluticasone/salmeterol
Sponsor: Novartis Pharmaceuticals
Start date: 2011-03-01; Completion date: 2012-03-01
Enrollment: 523 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety/tolerability of indacaterol and glycopyrronium (QVA149) (fixed-dose combination) with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.

Detailed description:

Arms: arm 1: Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol. arm 2: Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
Interventions: intervention 1: indacaterol and glycopyrronium (QVA149) intervention 2: Placebo to fluticasone/salmeterol intervention 3: fluticasone/salmeterol intervention 4: Placebo to indacaterol and glycopyrronium (QVA149)
Intervention descriptions: intervention 1: QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily. intervention 2: Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily. intervention 3: Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily. intervention 4: Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily

Protocol documents:
Clinical trial NCT01323153
Conditions: Coronary Heart Disease
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2012-03-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This double-blind, randomized, placebo-controlled, multi-center study will evaluate the safety and efficacy of dalcetrapib in patients hospitalized for an acute coronary syndrome (ACS). Treatment will be initiated within 1 week after the ACS. Patients will be randomized to receive dalcetrapib 600 mg as daily oral doses or matching placebo. The anticipated time on study treatment is 20 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: dalcetrapib intervention 2: placebo
Intervention descriptions: intervention 1: Oral doses of 600 mg once daily for 20 weeks intervention 2: Oral doses of matching placebo to dalcetrapib once daily for 20 weeks

Protocol documents:
Clinical trial NCT01324323
Conditions: Hematologic Malignancy Malignant Lymphoma
Keywords: ROMI-001 romi Romidepsin Istodax advanced malignancy PK pharmacokinetics
Sponsor: Celgene
Start date: 2011-04-01; Completion date: 2012-03-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect and safety of multiple doses of rifampin on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.

Detailed description:

Arms: arm 1: Romidepsin 14 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8.

Rifampin 600 mg oral once daily on Days 4-8
Interventions: intervention 1: Romidepsin intervention 2: Rifampin
Intervention descriptions: intervention 1: 14 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8. intervention 2: 600 mg oral once daily on Days 4-8

Protocol documents:
Clinical trial NCT01335581
Conditions: Refractory Mixed Type Melasma
Sponsor: ConBio, a Cynosure Company
Start date: 2011-04-01; Completion date: 2012-03-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the RevLite laser in the treatment of refractory mixed type melasma.

Detailed description:

Arms: arm 1: Laser treatment and microdermabrasion and topical lightening agent regimen arm 2: Microdermabrasion and topical lightening agent regimen
Interventions: intervention 1: Q-Switched Nd:YAG Laser (RevLite) intervention 2: Retin-A and microdermabrasion
Intervention descriptions: intervention 1: Laser treatment added to a microdermabrasion and topical lightening agent regimen intervention 2: Microdermabrasion and topical lightening agent regimen

Protocol documents:
Clinical trial NCT01336569
Conditions: Glaucoma
Keywords: Primary Open-Angle Glaucoma Ocular Hypertension Pigment Dispersion Glaucoma IOP
Sponsor: Alcon Research
Start date: 2011-02-01; Completion date: 2012-03-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
Interventions: intervention 1: Travoprost 0.004%/timolol maleate 0.5% fixed combination
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01336647
Conditions: Pediculosis
Sponsor: Dr. Reddy's Laboratories Limited
Start date: 2011-04-01; Completion date: 2012-03-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice

Detailed description:

Arms: arm 1: Group A Low-Dose Ha44 Gel 0.37% w/w topically administered to head and scalp.Single application for 10 minutes. arm 2: Group B High-Dose Ha44 Gel 0.74% w/w. Topically administered to hair and scalp. Single application for 10 minutes of duration. arm 3: Group C Placebo/ vehicle Ha44 Gel. Topically administered to hair and scalp.Single application for 10 minutes of duration.
Interventions: intervention 1: Group A - Low-Dose Ha44 0.37% w/w intervention 2: Group B - High Dose Ha44 Gel 0.74% w/w intervention 3: Group C - Placebo
Intervention descriptions: intervention 1: Low Dose Ha44 Gel applied to scalp and hair for 10 minutes intervention 2: High Dose Ha44 Gel applied to scalp and hair for 10 minutes intervention 3: Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes

Protocol documents: