ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00930644
Conditions: Short Bowel Syndrome
Keywords: short bowel syndrome parenteral nutrition PN HPN TPN SBS
Sponsor: Shire
Start date: 2009-09-21; Completion date: 2013-01-24
Enrollment: 88 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Detailed description:
Some people with SBS need to infuse parenteral nutrition (PN) in order to live. Although PN can save lives, it can lead to some serious side effects such as infection or liver damage. The risk for those effects increases the longer people are on PN.

Teduglutide is an investigative medicine being evaluated as a possible treatment for people with PN-dependent SBS. Teduglutide is similar to a protein the body makes. When people have SBS, their bodies do not make enough of the protein and they have trouble getting nutrients and fluids from the food they eat and drink. We want to see if teduglutide can help decrease the amount of PN needed because the body is doing a better job of taking up what it eats and drinks. We also want to find out how safe teduglutide is and record any side effects.

Arms: arm 1: 0.05 mg/kg/day
Interventions: intervention 1: teduglutide
Intervention descriptions: intervention 1: 0.05 mg/kg/day subcutaneously taken once per day for 24 months

Protocol documents:
Clinical trial NCT01272232
Conditions: Metabolism and Nutrition Disorder Obesity
Sponsor: Novo Nordisk A/S
Start date: 2011-06-01; Completion date: 2013-01-25
Enrollment: 846 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of this trial is to investigate the potential of liraglutide to induce and maintain weight loss in overweight or obese subjects with type 2 diabetes. Treatment will be added onto subject's pre-trial background diabetes treatment of either diet and exercise only or single compound oral antidiabetic drug (OAD) treatment (metformin, sulphonylurea \[SU\] or glitazone) or combination OAD treatment (metformin, sulphonylurea or glitazone). The duration of the trial will be 56 weeks followed by a 12 week observational follow-up period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: liraglutide intervention 2: liraglutide intervention 3: placebo
Intervention descriptions: intervention 1: Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks. intervention 2: Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks. intervention 3: Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.

Protocol documents:
Clinical trial NCT00988221
Conditions: Juvenile Idiopathic Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-11-30; Completion date: 2013-01-28
Enrollment: 188 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

Detailed description:

Arms: arm 1: Patients received tocilizumab 10 mg/kg intravenously every 4 weeks. arm 2: Patients received tocilizumab 8 mg/kg intravenously every 4 weeks. arm 3: Patients received tocilizumab 8 mg/kg intravenously every 4 weeks. arm 4: Patients received placebo to tocilizumab intravenously every 4 weeks.
Interventions: intervention 1: Tocilizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Tocilizumab was supplied as a sterile solution in vials. intervention 2: Placebo to tocilizumab was supplied as a sterile solution in vials.

Protocol documents:
Clinical trial NCT01364389
Conditions: Polymyalgia Rheumatica Inflammatory Diseases
Keywords: Polymyalgia Rheumatica Inflammatory Disease Rheumatic Disease
Sponsor: Novartis Pharmaceuticals
Start date: 2011-02-14; Completion date: 2013-01-29
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. It is a multicentric, multinational study. The protocol will seek to enroll a total of 30 patients, who will be randomized to the 3 arms at a ratio of 1:1:1.

Patients will have a maximum screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the case of a disease flare.

Detailed description:

Arms: arm 1: On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering. arm 2: On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering. arm 3: On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
Interventions: intervention 1: AIN457 intervention 2: ACZ885 intervention 3: Prednisone intervention 4: Placebo
Intervention descriptions: intervention 1: 3 mg/kg intervention 2: 3 mg/kg intervention 3: 20 mg intervention 4: Matching placebo to AIN457, ACZ885 and prednisone

Protocol documents:
Clinical trial NCT00859937
Conditions: Malignant Salivary Gland Neoplasm Recurrent Salivary Gland Carcinoma Salivary Gland Adenoid Cystic Carcinoma Stage IV Major Salivary Gland Cancer AJCC v7
Sponsor: National Cancer Institute (NCI)
Start date: 2009-03-16; Completion date: 2013-01-30
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well dasatinib works in treating patients with malignant salivary gland tumors that have come back after treatment or have spread to other parts of the body. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate (complete response plus partial response) of dasatinib in adenoid cystic carcinoma (ACC).

II. Determine the progression-free survival of dasatinib in ACC.

SECONDARY OBJECTIVES:

I. Determine the duration of response. II. Determine the stable disease rate and duration of stable disease. III. Determine progression-free survival. IV. Determine the median survival. V. Determine the overall survival. VI. Determine the safety and tolerability.

TERTIARY OBJECTIVES:

I. To examine biomarkers that relate to SRC proto-oncogene, non-receptor tyrosine kinase (Src) signal transduction and to correlate these biomarkers with clinical response to dasatinib in ACC and non-ACC malignant salivary gland tumors (MSGT).

II. Determine if activating mutations in platelet-derived growth factor alpha polypeptide (PDGFA) and KIT are associated with response in ACC.

OUTLINE:

Patients receive dasatinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed at 8 weeks.

Arms: arm 1: Patients receive dasatinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Dasatinib intervention 2: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT01628549
Conditions: Acne Vulgaris
Keywords: acne
Sponsor: Almirall, S.A.
Start date: 2012-06-30; Completion date: 2013-01-31
Enrollment: 285 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the safety and effectiveness of 3 strengths of P005672-HCl compared to placebo for the treatment of moderate to severe facial acne vulgaris.

Detailed description:

Arms: arm 1: One P005672-HCl 50 mg capsule and one Placebo capsule, oral administration, once daily for 12 weeks arm 2: Two P005672-HCl 50mg capsules, oral administration, once daily for 12 weeks arm 3: Two P005672-HCl 100mg capsules, oral administration, once daily for 12 weeks arm 4: Two Placebo capsules matching P005672-HCl, oral administration, once daily for 12 weeks
Interventions: intervention 1: 50 mg P005672-HCl intervention 2: Placebo intervention 3: 100 mg P005672-HCl
Intervention descriptions: intervention 1: P005672-HCl administered as an oral capsule(s) once daily intervention 2: Dose-matched Placebo capsule administered as an oral capsule(s) once daily intervention 3: P005672-HCl administered as an oral capsule(s) once daily

Protocol documents:
Clinical trial NCT00549757
Conditions: Type 2 Diabetes Mellitus Cardiovascular Disease
Keywords: Type 2 diabetes mellitus renal morbidity and mortality cardiovascular disease micro-albuminuria macro-albuminuria RAAS renin inhibitor Reduced estimated glomerular filtration rate
Sponsor: Novartis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2013-02-01
Enrollment: 8606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to determine whether, in patients with type 2 diabetes and pre-existing disease of the heart and the circulatory system and/or the kidney, aliskiren at a target dose of 300 mg once daily (compared to placebo), on top of conventional treatment, reduces death and disease caused by the heart, the circulatory system and the kidney.

AMENDMENT 4 RATIONALE (MARCH 2012) :

Protocol amendment 4 served to address the data monitoring committee recommendation dated 14 Dec 2011 to discontinue study treatment in all participating patients. It also addressed the subsequent Health Authorities request to implement a 12 month safety follow-up period (actual duration was 9 months in average) post study drug discontinuation.

Detailed description:

Arms: arm 1: In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.

With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment arm 2: In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.

With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
Interventions: intervention 1: Aliskiren intervention 2: Placebo
Intervention descriptions: intervention 1: Aliskiren 150 mg film-coated tablets intervention 2: Placebo to match aliskiren 150 mg film-coated tablets

Protocol documents:
Clinical trial NCT00678535
Conditions: Gastric Cancer
Keywords: 1st line treatment for Gastric Cancer Cetuximab Capecitabine Xeloda Cisplatin Progression-free survival
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-06-01; Completion date: 2013-02-01
Enrollment: 904 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate that addition of cetuximab to 1st-line treatment with capecitabine (Xeloda, X) and cisplatin (P) \[XP\] chemotherapy regimen has a clinically relevant benefit for subjects with advanced gastric adenocarcinoma including gastroesophageal junction (GEJ) adenocarcinoma, in terms of progression free survival (PFS).

Secondary objectives are to assess cetuximab plus XP versus XP alone with respect to overall survival, overall tumor response, quality of life (QoL) and safety.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cetuximab intervention 2: Capecitabine intervention 3: Cisplatin
Intervention descriptions: intervention 1: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously over 120 minutes followed by weekly intravenous infusion of cetuximab 250 mg/m\^2 over 60 minutes in each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent. intervention 2: Capecitabine 1000 mg/m\^2 will be administered orally twice daily from evening of Day 1 to morning of Day 15 for every 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent. intervention 3: Cisplatin 80 mg/m\^2 will be administered intravenously with infusion over 1 to 4 hours on Day 1 of each 3-week treatment cycle, until documented disease progression, unacceptable toxicity, or withdrawal of consent.

Protocol documents:
Clinical trial NCT01437397
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2011-09-01; Completion date: 2013-02-01
Enrollment: 1692 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase III study is to assess the maintenance bronchodilator effects of the fixed dose combination versus monotherapies. This study will also assess the effects of the fixed dose combination in terms of COPD symptoms, disease related health status and the long-term safety and tolerability of the fixed dose combination. This study will include a 24 week treatment period, preceding by a run-in period, followed by a two week follow up visit. All patients will be randomized to one of four treatment arms or placebo.

Detailed description:

Arms: arm 1: Aclidinium/formoterol Fixed Dose Combination (FDC) 400/12μg arm 2: Aclidinium/formoterol Fixed Dose Combination (FDC) 400/6μg arm 3: Aclidinium monotherapy 400 μg arm 4: Formoterol monotherapy 12 μg arm 5: Placebo
Interventions: intervention 1: Aclidinium Bromide/Formoterol Fumarate intervention 2: Aclidinium Bromide/Formoterol Fumarate intervention 3: Aclidinium Bromide intervention 4: Formoterol Fumarate intervention 5: Placebo
Intervention descriptions: intervention 1: Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day intervention 2: Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day intervention 3: Inhaled Aclidinium 400 μg, twice per day intervention 4: Inhaled Formoterol 12 μg, twice per day intervention 5: Inhaled dose-matched placebo, twice per day

Protocol documents:
Clinical trial NCT01473394
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder Depression
Sponsor: Forest Laboratories
Start date: 2011-12-01; Completion date: 2013-02-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to further characterize the efficacy, safety, and tolerability of a single fixed dose level of vilazodone compared to placebo in patients with major depressive disorder.

Detailed description:

Arms: arm 1: Participants received dose-matched placebo orally once daily for 9 weeks. arm 2: Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
Interventions: intervention 1: Dose-matched placebo intervention 2: Vilazodone
Intervention descriptions: intervention 1: Dose-matched placebo was supplied as tablets. intervention 2: Vilazodone was supplied as tablets.

Protocol documents:
Clinical trial NCT01478971
Conditions: Chronic Kidney Disease Anemia
Keywords: Anemia Chronic Renal Failure CRF Chronic Kidney Disease CKD Erythropoietin Hematide Peginesatide Hemoglobin Hgb Red Blood Cell Red Blood Cell Production Dialysis
Sponsor: Takeda
Start date: 2011-10-01; Completion date: 2013-02-01
Enrollment: 184 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to understand the effects of a dialysis center switching its dialysis patients from using Epoetin alfa to peginesatide injection on hemoglobin levels and other parameters.

Detailed description:
Monthly Erythropoiesis-Stimulating Agents (ESA) dosing, compared with the longstanding practice of dosing three times per week, represents a significant change in anemia treatment for dialysis patients. Because of the differences in the processes needed to support monthly dosing versus thrice weekly dosing, there is a need to prospectively identify and evaluate factors in the dialysis environment during center-level transition of patients from one ESA to another.

AFX01-18 is a Phase 3b open-label, single-arm conversion study that was conducted at 5 hemodialysis sites in the United States, and enrolled Chronic Kidney Disease (CKD) patients receiving outpatient, in-center hemodialysis. The study treatment period was approximately 12 months in duration. Participants received peginesatide injection for approximately six months.

Arms: arm 1: In the first 6 months participants received standard of care treatment with epoetin (the Standard of Care Period \[SCP\]), followed by a 1-week erythropoiesis-stimulating agent (ESA)-Free Period, followed by peginesatide injection for 6 months (the Peginesatide Treatment Period \[PTP\]).
Interventions: intervention 1: Epoetin intervention 2: Peginesatide
Intervention descriptions: intervention 1: Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous \[IV\] or subcutaneous \[SC\]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of \<11 g/dL. intervention 2: Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at \<11 g/dL.

Protocol documents:
Clinical trial NCT01542788
Conditions: Chronic Hepatitis C
Keywords: HCV genotype 2 (GT-2) HCV genotype 3 (GT-3) HCV Sustained Virologic Response Direct Acting Antiviral Combination Therapy Interferon intolerant Interferon ineligible GS-7977 Ribavirin
Sponsor: Gilead Sciences
Start date: 2012-03-01; Completion date: 2013-02-01
Enrollment: 278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multicenter study was to evaluate subjects with chronic genotype 2 or 3 HCV infection who were interferon (IFN) ineligible, IFN intolerant or unwilling to take IFN. Participants were randomized in a 3:1 ratio to receive sofosbuvir (SOF)+ribavirin (RBV), or placebo to match SOF+placebo to match RBV. Randomization was stratified by presence/absence of cirrhosis. Approximately 20% of participants may have had evidence of cirrhosis at screening.

Detailed description:
Participants who were randomized to the placebo arm and completed all scheduled study procedures were eligible to receive active SOF+RBV in open-label Study GS-US-334-0109.

Participants who do not achieve sustained virologic response (SVR) were eligible for enrollment in the Sequence Registry Study GS-US-248-0123. The purpose of the Sequence Registry Study is to monitor the persistence of resistant mutations for up to 3 years.

Participants who achieved SVR were eligible for enrollment in the SVR Registry Study GS-US-248-0122. The purpose of the SVR Registry Study is to evaluate durability of SVR for up to 3 years after treatment.

Arms: arm 1: Participants were randomized to receive SOF+RBV for 12 weeks. arm 2: Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks.
Interventions: intervention 1: SOF intervention 2: RBV intervention 3: Placebo to match SOF intervention 4: Placebo to match RBV
Intervention descriptions: intervention 1: Sofosbuvir (SOF) 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). intervention 3: Placebo to match SOF was administered orally once daily. intervention 4: Placebo to match RBV was administered orally twice daily.

Protocol documents: