ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01552915
Conditions: Attention-deficit/Hyperactivity Disorder
Keywords: ADHD
Sponsor: Shire
Start date: 2012-04-17; Completion date: 2014-01-22
Enrollment: 464 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lisdexamfetamine dimesylate intervention 2: Methylphenidate Hydrochloride intervention 3: Placebo
Intervention descriptions: intervention 1: Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance intervention 2: Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance intervention 3: Daily oral dosing in the AM for 8 weeks

Protocol documents:
Clinical trial NCT02465203
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, chronic
Sponsor: Novartis Pharmaceuticals
Start date: 2012-09-06; Completion date: 2014-01-23
Enrollment: 105 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

Detailed description:
The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.

Arms: arm 1: Follow up arm
Interventions: intervention 1: Previous treatment in DEB025 study
Intervention descriptions: intervention 1: Follow-up after DEB025 active study

Protocol documents:
Clinical trial NCT01740791
Conditions: Chronic Hepatitis C Virus
Keywords: Hepatitis C HCV Genotype 1 Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 Liver Disease
Sponsor: Gilead Sciences
Start date: 2012-11-06; Completion date: 2014-01-24
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the safety, tolerability, and antiviral activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes 1-6.

Detailed description:

Arms: arm 1: Participants with genotype (GT) 1a HCV infection will receive velpatasvir 5 mg or placebo once daily for 3 days under fasted conditions. arm 2: Participants with GT 1a HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. arm 3: Participants with GT 1a HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. arm 4: Participants with GT 1a HCV infection will receive velpatasvir 100 mg or placebo once daily for 3 days under fasted conditions. arm 5: Participants with GT 1a HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. arm 6: Participants with GT 1b HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. arm 7: Participants with GT 2 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. arm 8: Participants with GT 3 HCV infection will receive velpatasvir 25 mg or placebo once daily for 3 days under fasted conditions. arm 9: Participants with GT 3 HCV infection will receive velpatasvir 50 mg or placebo once daily for 3 days under fasted conditions. arm 10: Participants with GT 3 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. arm 11: Participants with GT 4 HCV infection will receive velpatasvir 150 mg or placebo once daily for 3 days under fasted conditions. arm 12: Participants with GT 2 HCV infection will receive velpatasvir up to 400 mg or placebo once daily for 3 days under fasted conditions.
Interventions: intervention 1: Velpatasvir intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets administered orally intervention 2: Tablets administered orally

Protocol documents:
Clinical trial NCT01918033
Conditions: Perennial Allergic Rhinitis
Keywords: Rhinitis Allergic Rhinitis Nose Diseases Respiratory Tract Diseases Immune System Diseases Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents
Sponsor: Organon and Co
Start date: 2013-08-20; Completion date: 2014-01-26
Enrollment: 608 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with perennial allergic rhinitis. The primary hypothesis is that desloratadine is superior to placebo after 2 weeks of treatment with regard to change from baseline in Total Nasal Symptom Score among Japanese participants with perennial allergic rhinitis.

Detailed description:

Arms: arm 1: Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks arm 2: Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks arm 3: Participants receive two placebo tablets orally once daily for up to 2 weeks
Interventions: intervention 1: Desloratadine 5 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Desloratadine 5 mg tablets intervention 2: Matching placebo to desloratadine 5 mg tablets

Protocol documents:
Clinical trial NCT01557452
Conditions: Juvenile Idiopathic Arthritis
Keywords: JIA
Sponsor: Italfarmaco
Start date: 2011-12-28; Completion date: 2014-01-27
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective of the study:

the purpose of this extension study was to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit at least pediACR30 response);

Detailed description:
Givinostat is expected to exert a clinically relevant therapeutic effect on polyarticular JIA through the inhibition of the production/release of pro-inflammatory cytokines, such as IL-1β, IL-6 and TNFα, which are involved in the pathogenesis of the arthritic process.

Arms: arm 1: Patient received the dose of 0.75 mg/kg BID from December 28th, 2011 to January 27th, 2014
Interventions: intervention 1: Givinostat
Intervention descriptions: intervention 1: ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients

Protocol documents:
Clinical trial NCT01007435
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-10-31; Completion date: 2014-01-28
Enrollment: 1162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, parallel group study will assess the safety, disease remission, and prevention of structural joint damage in patients with early moderate to severe rheumatoid arthritis treated with tocilizumab as monotherapy or in combination with methotrexate, versus methotrexate alone. Patients will be randomized to receive either (A) tocilizumab (8 mg/kg iv every 4 weeks) plus placebo, (B) tocilizumab (8 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), (C) tocilizumab (4 mg/kg iv every 4 weeks) plus methotrexate (7.5-20 mg po weekly), or (D) placebo plus methotrexate (7.5-20 mg po weekly). Patients in groups C and D who have not achieved low disease activity at week 52 can receive tocilizumab 8 mg/kg iv every 4 weeks. Anticipated time on study treatment is 104 weeks.

Detailed description:

Arms: arm 1: Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks. arm 2: Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks. arm 3: Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks. arm 4: Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
Interventions: intervention 1: Tocilizumab intervention 2: Placebo to tocilizumab intervention 3: Methotrexate intervention 4: Placebo to methotrexate
Intervention descriptions: intervention 1: Tocilizumab was supplied in vials. intervention 2: Placebo to tocilizumab was supplied in vials. intervention 3: Initially, patients received methotrexate 7.5 mg (3, 2.5 mg tablets) orally once a week. If a patient had swollen or tender joints, the dose was increased to 15 mg and 20 mg weekly, at the Week 4 and Week 8 visits, respectively. intervention 4: Patients received placebo to methotrexate orally once a week.

Protocol documents:
Clinical trial NCT00925301
Conditions: Fabry Disease
Keywords: Amicus Therapeutics AT1001 Migalastat Pharmacokinetics Substrate Galafold
Sponsor: Amicus Therapeutics
Start date: 2009-10-23; Completion date: 2014-01-29
Enrollment: 67 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to compare the effect of migalastat (123 milligrams \[mg\] of migalastat \[equivalent to 150 mg of migalastat hydrochloride\]) (migalastat) versus placebo on kidney globotriaosylceramide (GL-3).

Detailed description:
This double-blind, randomized, placebo-controlled study was conducted in 67 participants at 46 sites worldwide. The study consisted of 2 stages and an optional open-label treatment extension phase:

Stage 1 included a screening period of up to 2 months followed by a 6-month treatment period which involved 4 visits to the clinic. Participants were randomized in equal proportions to receive either migalastat or placebo.

After completing the 6-month double-blind phase, all participants entered Stage 2 of the study and received migalastat in an open-label manner. Stage 2 treatment lasted for 6 months and involved up to 4 visits to the clinic.

Participants who completed both Stage 1 and Stage 2 of the study as scheduled were offered the opportunity to participate in an open-label treatment extension phase with migalastat. The open-label treatment extension phase lasted 12 months and involved 2 visits to the clinic. A follow-up visit was undertaken 1 month following completion or discontinuation from the open-label treatment extension. Participants completing the 12-month open-label treatment extension and providing consent to enter a separate long-term extension were not required to complete this follow-up visit.

Study assessments included clinical laboratory tests, 12-lead electrocardiogram, kidney biopsy, kidney function testing, echocardiography, and patient-reported outcomes.

Arms: arm 1: Migalastat 150-mg capsule taken orally every other day (QOD) for 6 months and an open-label 6-month treatment extension, followed by an optional, 12-month, open-label treatment extension. arm 2: Placebo capsule taken orally QOD for 6 months.
Interventions: intervention 1: migalastat hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Oral capsule QOD intervention 2: Oral capsule QOD

Protocol documents:
Clinical trial NCT01710501
Conditions: Chronic Hepatitis C (CHC)
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-12-07; Completion date: 2014-01-29
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study designed to compare the safety and efficacy of 3 different doses of grazoprevir (MK-5172) combined with pegylated interferon alfa-2b (PEG-IFN) and ribavirin (RBV) in treatment-naïve participants with genotype 1 (GT1) chronic hepatitis C (CHC). Participants will receive 12 weeks of treatment with grazoprevir combined with Peg-IFN and RBV, and depending on response at Week 4 may go on to receive an additional 12 weeks of treatment with Peg-IFN and RBV.

Detailed description:

Arms: arm 1: After a maximum of a 45 day screening window, randomized participants receive 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by Response Guided Therapy (RGT). Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their Hepatitis C virus ribonucleic acid (HCV RNA) level at Treatment Week (TW) 4. arm 2: After a maximum of a 45 day screening window, randomized participants receive 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4. arm 3: After a maximum of a 45 day screening window, randomized participants receive 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants may receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
Interventions: intervention 1: Grazoprevir intervention 2: pegylated interferon alfa-2b intervention 3: Ribavirin intervention 4: Placebo
Intervention descriptions: intervention 1: Grazoprevir tablet, orally, once per day at assigned dose intervention 2: 1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection intervention 3: Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight intervention 4: Placebo to match grazoprevir tablets to maintain dose blinding

Protocol documents:
Clinical trial NCT01588496
Conditions: Homozygous Familial Hypercholesterolemia
Keywords: hypercholesterolemia familial hypercholesterolemia homozygous familial hypercholesterolemia
Sponsor: Amgen
Start date: 2012-04-05; Completion date: 2014-01-31
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to determine the safety, tolerability, and efficacy of evolocumab (AMG 145) in patients with homozygous familial hypercholesterolemia (HoFH).

Detailed description:
Study Masking:

Part A: Open Label Part B: Double Blind

Arms: arm 1: Participants received open-label evolocumab 420 mg subcutaneously once a month for 12 weeks. arm 2: Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks. arm 3: Participants received double-blind placebo subcutaneously once a month for 12 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT00883116
Conditions: Endometrial Cancer
Sponsor: R-Pharm
Start date: 2009-08-01; Completion date: 2014-02-01
Enrollment: 551 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as assessed by overall survival compared with that achieved with standard chemotherapy (paclitaxel or doxorubicin) in women with advanced endometrial cancer that has progressed following first-line chemotherapy.

Detailed description:

Arms: arm 1: Participants received ixabepilone, 40 mg/m\^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression arm 2: Participants received either paclitaxel, 175 mg/m\^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m\^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m\^2.
Interventions: intervention 1: Ixabepilone intervention 2: Doxorubicin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00913835
Conditions: Ovarian Neoplasms
Keywords: Liposomal Doxorubicin IMC-3G3 3G3 Platinum resistant Platinum refractory Ovary Neoplasm PDGFr
Sponsor: Eli Lilly and Company
Start date: 2009-06-01; Completion date: 2014-02-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if participants with platinum-refractory or platinum-resistant advanced ovarian cancer have a better outcome when treated with Olaratumab (IMC-3G3) in combination with Liposomal Doxorubicin than when treated with Liposomal Doxorubicin alone.

Detailed description:
The primary objective of this study is to evaluate the progression-free survival (PFS) in participants with platinum-refractory or platinum-resistant advanced ovarian cancer when treated with the monoclonal antibody Olaratumab in combination with liposomal doxorubicin versus liposomal doxorubicin alone.

Arms: arm 1: Olaratumab and Liposomal Doxorubicin arm 2: Liposomal Doxorubicin Monotherapy until disease progression. Upon disease progression the participant had the option to receive Olaratumab monotherapy.
Interventions: intervention 1: Olaratumab intervention 2: liposomal doxorubicin
Intervention descriptions: intervention 1: 20 milligrams per kilogram (mg/kg) administered by intervenous (IV) infusion every 2 weeks (14 days). Treatment will continue until there is evidence of progressive disease (PD) or development of unacceptable toxicity intervention 2: 40 milligrams per square meter (mg/m²) administered according to the manufacture's instructions every 4 weeks (28 days). Treatment will continue until there is evidence of PD or development of unacceptable toxicity

Protocol documents:
Clinical trial NCT00994318
Conditions: Iron Deficiency Anaemia Chronic Kidney Disease
Keywords: Ferinject Iron Deficiency Anaemia Chronic Kidney Disease
Sponsor: Vifor Pharma
Start date: 2009-12-01; Completion date: 2014-02-01
Enrollment: 626 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase IIIb study to evaluate the long-term efficacy of ferric carboxymaltose (FCM) (using targeted ferritin levels to determine dosing) or oral iron in non-dialysis-dependent chronic kidney disease (NDD-CKD) subjects with iron deficiency anaemia (IDA).

Detailed description:
After an initial screening period of up to 4 weeks, eligible subjects were randomised (1:1:2) to 1 of the following 3 treatment arms for a period of 52 weeks.

1. FCM regimen (maximum single intravenous doses of 1,000 mg of iron) targeting a ferritin level of 400-600 mcg/L.
2. FCM regimen (maximum single intravenous doses of 200 mg of iron) targeting a ferritin level of 100-200 mcg/L.
3. Daily oral iron with 200 mg iron/day (100 mg twice daily)

Arms: arm 1: Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L arm 2: Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L arm 3: Ferrous sulphate 100 mg iron twice daily, continuous
Interventions: intervention 1: FCM (Ferric carboxymaltose) high ferritin target intervention 2: FCM (Ferric carboxymaltose) low ferritin target intervention 3: Oral Iron (Ferrous sulphate)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01183858
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2010-10-01; Completion date: 2014-02-01
Enrollment: 315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This prospective, double-blind, randomized study will evaluate the safety and efficacy of two dose levels of erlotinib \[Tarceva\] on progression-free survival, response and disease control rates and overall survival in patients with advanced or metastatic non-small cell lung cancer (NSCLC) after failure of first-line platinum-based chemotherapy. Patients must be current smokers and not intending to stop smoking during the study. Patients will be randomized to receive either 150 mg or 300 mg of study drug as single daily oral doses. Treatment will continue until disease progression.

Detailed description:

Arms: arm 1: Erlotinib 150 mg single daily oral dose until disease progression. arm 2: Erlotinib 300 mg single daily oral dose until disease progression.
Interventions: intervention 1: Erlotinib [Tarceva]
Intervention descriptions: intervention 1: Single daily oral dose

Protocol documents:
Clinical trial NCT01332227
Conditions: HIV, Combination Therapy
Sponsor: Bristol-Myers Squibb
Start date: 2011-10-01; Completion date: 2014-02-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether HIV-1-infected patients, who are virologically suppressed on a regimen of 2 nucleoside reverse transcriptase inhibitors plus any third agent but are experiencing safety and/or tolerability issues, will maintain virologic suppression after switching to a regimen of heat-stable ritonavir boosted atazanavir, 300/100 mg, once daily plus raltegravir, 400 mg, twice daily.

Detailed description:
Allocation: Randomized nonstratified

Intervention model: Parallel versus comparator

Arms: arm 1: Atazanavir + Ritonavir (heat-stable) + Raltegravir arm 2: Reference

Atazanavir + Ritonavir (heat-stable) + Tenofovir/Emtricitabine
Interventions: intervention 1: Atazanavir intervention 2: Ritonavir (heat-stable) intervention 3: Raltegravir intervention 4: Tenofovir/Emtricitabine
Intervention descriptions: intervention 1: Capsules, Oral, 300mg, Once daily, 48 weeks intervention 2: Tablets, Oral, 100 mg, Once daily, 48 weeks intervention 3: Tablets, Oral, 400 mg, Twice daily, 48 weeks intervention 4: Tablets, Oral, 300/200 mg, Once daily, 48 weeks

Protocol documents:
Clinical trial NCT01332994
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-03-01; Completion date: 2014-02-01
Enrollment: 519 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: tocilizumab [RoActemra/Actemra] intervention 3: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 1 g intravenously at Week 16 and 18 intervention 2: 8 mg/kg intravenously every 4 weeks for 12 weeks. intervention 3: 8 mg/kg intravenously every 4 weeks from Week 16 to Week 28

Protocol documents: