ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01275066
Conditions: MPS IV A
Keywords: Mucopolysaccharidosis IV type A MPS IV Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT
Sponsor: BioMarin Pharmaceutical
Start date: 2011-02-01; Completion date: 2012-08-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase 3 study will evaluate the efficacy and safety of 2.0 mg/kg/week BMN 110 and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome).

There is currently no standard accepted treatment for MPS IVA other than supportive care. Enzyme replacement therapy (ERT) may be a potential new treatment option for MPS IVA patients. BMN 110 is administered to MPS IVA patients by IV infusion, allowing cellular uptake by the mannose-6-phosphate receptor and transportation to the lysosomes.

This enzyme uptake into the lysosomes is hypothesized to promote increased catabolism of keratan sulfate (KS) in tissue macrophages, hyaline cartilage, other connective tissues, and heart valve, and reduce the progressive accumulation of KS which is responsible for the clinical manifestations of the disorders.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: BMN 110 Weekly intervention 2: Placebo intervention 3: BMN 110 Every Other Week
Intervention descriptions: intervention 1: BMN 110 Weekly: Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week. intervention 2: Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week. intervention 3: BMN 110 Every Other Week: Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.

Protocol documents:
Clinical trial NCT01283971
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-05-01; Completion date: 2012-08-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly. arm 2: Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: adalimumab intervention 3: placebo to tocilizumab intervention 4: placebo to adalimumab intervention 5: methotrexate intervention 6: folate
Intervention descriptions: intervention 1: Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks. intervention 2: Adalimumab 40 mg SC every 2 weeks. intervention 3: Placebo to tocilizumab IV every 4 weeks for 24 weeks. intervention 4: Placebo to adalimumab SC every 2 weeks for 24 weeks. intervention 5: Methotrexate 10-25 mg weekly. intervention 6: Folate at least 5 mg weekly.

Protocol documents:
Clinical trial NCT01288079
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder MDD Monotherapy Inadequate Response to Antidepressant Therapy
Sponsor: AstraZeneca
Start date: 2011-02-01; Completion date: 2012-08-01
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and effect of TC-5214 as a single therapy in patients with major depressive disorder who exhibit inadequate response to antidepressants.

Detailed description:

Arms: arm 1: TC-5214, 1 mg BID arm 2: TC-5214, 4 mg BID arm 3: Duloxetine 60 mg Q Day arm 4: Placebo
Interventions: intervention 1: TC-5214 intervention 2: Duloxetine intervention 3: Placebo
Intervention descriptions: intervention 1: Tablet, oral, twice daily for 8 weeks intervention 2: Capsule, oral, once daily intervention 3: Tablet, oral, twice daily for 8 weeks

Protocol documents:
Clinical trial NCT01289574
Conditions: Acne
Keywords: androgen receptor degradation enhancer
Sponsor: AndroScience Corp
Start date: 2011-02-01; Completion date: 2012-08-01
Enrollment: 181 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and efficacy of topical 0.1% and 0.025% ASC-J9 creams applied twice daily for facial acne compared to vehicle control.

Detailed description:
Approximately 180 patients at least 12 years of age with facial acne will be randomized to twice daily topical treatment with 0.1% or 0.025% ASC-J9 cream or vehicle control for 12 weeks. Patients will return to the clinic at Weeks 2, 4, 8 and 12 and again 4 weeks after the last dose of study drug for evaluation of acne status and safety parameters.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: ASC-J9
Intervention descriptions: intervention 1: Cream for twice daily topical application to the face

Protocol documents:
Clinical trial NCT01290731
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic Hepatitis C virus Interferon Alfa-2a Ribavirin Viral RNA
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2011-01-01; Completion date: 2012-08-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in Japan.

Detailed description:
This is a single-arm study to evaluate the efficacy and safety of TMC435 in combination with the standard of care (SoC), PegIFNα-2a (P) and ribavirin (R), in adult, genotype 1 HCV-infected participants who relapsed after previous IFN-based therapy in Japan. The study objective is to evaluate the efficacy of TMC435 by the percentage of participants with undetectable HCV ribonucleic acid (RNA). Participants will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus PR followed by 12 or 36 weeks of treatment with PR. TMC435 is a 100-mg capsule and will be taken orally (via the mouth). Treatment with PR will last 24 or 48 weeks. Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 µg PegIFNα-2a and will be injected by a syringe under the skin once weekly. Ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg), taken orally two times a day after meals. The participants will receive oral capsules of TMC435 (100 mg) once daily up to Week 12.

Arms: arm 1: Participants will receive TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment will be stopped at Week 24 in participants who achieve plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants will continue PR until Week 48 (PR 48).
Interventions: intervention 1: TMC435 intervention 2: Pegylated interferon (pegIFN alpha-2a) intervention 3: Ribavirin (RBV)
Intervention descriptions: intervention 1: 100-mg capsule once daily for 12 weeks intervention 2: 180 mcg injected subcutaneously (by a syringe under the skin) once weekly for 12 to 36 weeks (or until Week 48). intervention 3: 200-mg tablets (daily dose: 600-1000 mg) taken orally (by mouth) two times a day for 12 to 36 weeks (or until Week 48).

Protocol documents:
Clinical trial NCT01293825
Conditions: Medication Adherence Bipolar Disorder
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2011-01-01; Completion date: 2012-08-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Psychotropic-related weight gain is a common concern among patients with bipolar disorder (BD). This concern affects an individual's satisfaction with treatment and may lead to reduced adherence and illness relapse. Patient-focused care is attentive to patient concerns while at the same time utilizing evidence-based treatments. Ziprasidone is currently FDA approved for the maintenance treatment of BD. Ziprasidone may be associated with less weight gain compared to some alternative BD maintenance treatments. The proposed project will evaluate how switching to ziprasidone may affect patient adherence, drug attitudes, satisfaction with care and clinical outcomes (psychiatric symptoms, functional status, weight) among BD patients concerned with weight gain.

Detailed description:

Arms: arm 1: There was only one group in this study. All participants received the study drug Ziprasidone.
Interventions: intervention 1: ziprasidone
Intervention descriptions: intervention 1: Patients will identify which psychotropic they currently receive that causes the most weight-gain concern. For individuals on multiple drugs, one drug must be identified as the "offending agent". Study psychiatrist will switch the "offending agent" to ziprasidone. Participants will be switched to ziprasidone per package insert. Patients will be maintained on ziprasidone for 12 weeks (active part of study). After the active part of the study they will return to the care of their normal clinical provider who will determine whether they will continue on ziprasidone.

Protocol documents:
Clinical trial NCT01298765
Conditions: Pain Low Back Pain Osteoarthritis Neuropathic Pain
Keywords: buccal soluble film
Sponsor: BioDelivery Sciences International
Start date: 2011-03-01; Completion date: 2012-08-01
Enrollment: 302 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether BEMA Buprenorphine is safe in the treatment of chronic pain.

Detailed description:
This is an open label study of up to approximately 52 weeks duration to assess the safety and effectiveness of BEMA Buprenorphine in the management of moderate to severe chronic pain.

BEMA Buprenorphine is an oral transmucosal form of the opioid analgesic, buprenorphine hydrochloride, intended for application to the buccal mucosa. Buprenorphine is a synthetic opioid that is classified as a partial μ-receptor agonist and a Schedule III controlled substance in the United States.

Arms: arm 1: buprenorphine buccal soluble film
Interventions: intervention 1: BEMA Buprenorphine
Intervention descriptions: intervention 1: buccal soluble film; applied to the buccal mucosa twice daily

Protocol documents:
Clinical trial NCT01302938
Conditions: Overactive Bladder
Keywords: Double-blind Placebo-controlled frequency urgency web-based incontinence methodology ediary safety efficacy tolerability ER overactive bladder
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2011-03-01; Completion date: 2012-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the effect of tolterodine ER 4 mg to placebo on patient reported outcomes in subjects with overactive bladder after 1, 4, and 12 weeks of treatment using an innovative web-based trial design

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tolterodine ER intervention 2: Placebo
Intervention descriptions: intervention 1: One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing. intervention 2: A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.

Protocol documents:
Clinical trial NCT01308619
Conditions: Rosacea
Sponsor: Galderma R&D
Start date: 2011-04-01; Completion date: 2012-08-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with rosacea-related inflammatory markers.

Detailed description:

Arms: arm 1: Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules arm 2: placebo
Interventions: intervention 1: Doxycycline intervention 2: Placebo
Intervention descriptions: intervention 1: doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning intervention 2: Placebo, oral, one capsule daily in the morning

Protocol documents:
Clinical trial NCT01309841
Conditions: Opioid-Induced Constipation (OIC)
Keywords: Non-Cancer-Related Pain, Opioid-Induced Constipation
Sponsor: AstraZeneca
Start date: 2011-03-01; Completion date: 2012-08-01
Enrollment: 652 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of opioid-induced constipation in patients with non-cancer-related pain, including those patients that have inadequate response to laxative therapy (LIR).

Detailed description:

Arms: arm 1: Oral treatment arm 2: Oral treatment arm 3: Oral treatment
Interventions: intervention 1: NKTR-118 intervention 2: NKTR-118 intervention 3: Placebo
Intervention descriptions: intervention 1: 12.5 mg oral tablet once daily intervention 2: 25 mg oral tablet once daily intervention 3: Oral tablet once daily

Protocol documents:
Clinical trial NCT01329978
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C HCV Chronic Hepatitis C
Sponsor: Gilead Sciences
Start date: 2011-03-01; Completion date: 2012-08-01
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

Detailed description:

Arms: arm 1: Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks. arm 2: Participants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks. arm 3: Participants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
Interventions: intervention 1: Sofosbuvir intervention 2: RBV intervention 3: PEG
Intervention descriptions: intervention 1: Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) intervention 3: Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Protocol documents:
Clinical trial NCT01331109
Conditions: Primary Fibromyalgia
Keywords: Fibromyalgia Pediatric Fibromyalgia Adolescent Fibromyalgia milnacipran Savella loss of therapeutic response Forest Research Institute Pain Fatigue Serotonin Norepinephrine Reuptake Inhibitors
Sponsor: Forest Laboratories
Start date: 2011-04-01; Completion date: 2012-08-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.

Detailed description:

Arms: arm 1: oral administration, twice daily dosing
Interventions: intervention 1: Milnacipran
Intervention descriptions: intervention 1: maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.

Protocol documents:
Clinical trial NCT01332253
Conditions: Tonsillectomy
Keywords: Tonsillectomy, Pediatric
Sponsor: Cumberland Pharmaceuticals
Start date: 2011-07-01; Completion date: 2012-08-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The hypothesis is that a single, pre-operative dose of intravenous ibuprofen will significantly reduce post-operative fentanyl use compared to placebo.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Intravenous ibuprofen intervention 2: Normal Saline
Intervention descriptions: intervention 1: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia. intervention 2: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.

Protocol documents:
Clinical trial NCT01341730
Conditions: Atherosclerosis Coronary Artery Disease
Keywords: Atherosclerosis Pioglitazone Atorvastatin PET CT
Sponsor: The Catholic University of Korea
Start date: 2011-06-01; Completion date: 2012-08-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a prospective randomized clinical trial and to compare the antiinflammatory effect of atorvastatin single therapy and atorvastatin and pioglitazone combination therapy in carotid arteries of stable and unstable angina patients by PET/CT.

Detailed description:

Arms: arm 1: After the subject take PET CT, he or she is randomized to either " Atorvastatin 20 mg" group or " Atorvastatin 20 mg+ Pioglitazone 30 mg". The " Atorvastatin 20 mg" group is to take atorvastatin 20 mg and take follow up PET CT in 3 months arm 2: After the subject take PET CT, he or she is randomized to either " Atorvastatin 20 mg" group or " Atorvastatin 20 mg+ Pioglitazone 30 mg". The " Atorvastatin 20 mg + Pioglitazone 30 mg" group is to take atorvastatin 20 mg + pioglitazone 30 mg and take follow up PET CT in 3 months
Interventions: intervention 1: Atorvastatin 20mg intervention 2: Atorvastatin 20 mg + Pioglitazone 30 mg
Intervention descriptions: intervention 1: 20 mg QD for 3 months intervention 2: atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months

Protocol documents:
Clinical trial NCT01353508
Conditions: Hypertension
Keywords: Sodium excretion, LCZ696
Sponsor: Novartis Pharmaceuticals
Start date: 2011-03-01; Completion date: 2012-08-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Assess mechanism of action of LCZ696 related to sodium excretion.

Detailed description:

Arms: arm 1: Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2. arm 2: Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2. arm 3: Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2. arm 4: Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
Interventions: intervention 1: LCZ696 intervention 2: Valsartan
Intervention descriptions: intervention 1: 200 mg and 400 mg tablets intervention 2: 160 mg tablets

Protocol documents:
Clinical trial NCT01353976
Conditions: Tinea Pedis Athlete's Foot
Keywords: Econazole Nitrate Foam Quinnova Tinea Pedis
Sponsor: AmDerma
Start date: 2011-05-01; Completion date: 2012-08-01
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of the safety and efficacy of topical Econazole Nitrate Foam 1% and the foam vehicle in subjects with interdigital tinea pedis (athlete's foot between the toes). This is a 6 week study which has a 4 week treatment period and a 2 week follow-up evaluation.

Detailed description:

Arms: arm 1: Study medication arm 2: Placebo medication
Interventions: intervention 1: Econazole Nitrate Foam 1% intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: Econazole Nitrate Foam 1% applied once a day for 4 weeks intervention 2: Vehicle foam applied once a day for 4 weeks

Protocol documents:
Clinical trial NCT01360021
Conditions: Asthma
Sponsor: AstraZeneca
Start date: 2011-11-01; Completion date: 2012-08-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a comparison of the efficacy of the Symbicort breath actuated dose inhaler to the Symbicort pressured meter dose inhaler after 12 weeks of a twice a day dose.

Detailed description:

Arms: arm 1: Symbicort BA MDI 2x160/4.5 μg twice daily arm 2: Symbicort AC pDMI 2x160/4.5 μg twice daily arm 3: Budesonide AC pMDI 2x160 μg twice daily
Interventions: intervention 1: Symbicort intervention 2: Symbicort intervention 3: Budesonide
Intervention descriptions: intervention 1: Breath actuated metered dose inhaler intervention 2: Actuation counter pressured metered dose inhaler intervention 3: Actuation counter pressured metered dose inhaler

Protocol documents:
Clinical trial NCT01392547
Conditions: Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors
Sponsor: Novo Nordisk A/S
Start date: 2011-07-01; Completion date: 2012-08-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial is conducted globally. The purpose of this trial is to confirm the efficacy and safety of NNC 0078-0000-0007 in patients with congenital haemophilia and inhibitors.

Detailed description:
Scheduled dose visit in a non-bleeding state. Single dose of NNC 0078-0000-0007 (vatreptocog alfa (activated)) every 3 months.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: vatreptacog alfa (activated) intervention 2: eptacog alfa (activated)
Intervention descriptions: intervention 1: 1-3 doses per bleeding episode intervention 2: 1-3 doses per bleeding episode

Protocol documents:
Clinical trial NCT01392560
Conditions: Diabetes Mellitus, Type 1
Sponsor: Boehringer Ingelheim
Start date: 2011-06-01; Completion date: 2012-08-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study aims to evaluate the impact of BI 10773 treatment on glomerular filtration rate under controlled conditions of euglycaemia and hyperglycaemia in subjects with type 1 diabetes mellitus with or without renal hyperfiltration and to characterize the safety and efficacy of BI 10773 25 mg QD as add-on therapy to insulin in these subjects.

Detailed description:

Arms: arm 1: Oral once daily
Interventions: intervention 1: BI 10773
Intervention descriptions: intervention 1: Oral once daily

Protocol documents: