ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01536574
Conditions: Parkinson Disease
Sponsor: GlaxoSmithKline
Start date: 2010-09-02; Completion date: 2012-03-28
Enrollment: 295 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open label extension study allows assessment of the long term safety profile of REQUIP PR in subjects who have completed 24 weeks of randomised treatment in study ROP111528.

Subjects must not have a break in study medication between completing the feeder study and entering extension study, treatment must be continuous.

Subjects will be dispensed down-titration medication at the study completion/early withdrawal visit and should be scheduled to return for a follow up visit 4 to 14 days after the last dose of study medication.

Detailed description:

Arms: arm 1: Ropinirole PR tablets of 2.0 mg, 4.0mg and 8.0 mg
Interventions: intervention 1: Requip PR
Intervention descriptions: intervention 1: Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.

Protocol documents:
Clinical trial NCT00877006
Conditions: Non-Hodgkin's Lymphoma Mantle Cell Lymphoma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2009-04-30; Completion date: 2012-03-31
Enrollment: 447 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to compare the complete response (CR) rate of bendamustine and rituximab (BR) with that of standard treatment regimens of either rituximab, cyclophosphamide, vincristine, and prednisone (R-CVP) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with advanced, indolent non-Hodgkin's lymphoma (NHL) or mantle cell lymphoma (MCL).

Detailed description:

Arms: arm 1: Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m\^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m\^2 IV on Day 1 arm 2: Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.

R-CHOP: rituximab 375 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m\^2 IV Day 1; cyclophosphamide 750 mg/m\^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5

R-CVP: rituximab 375 mg/m\^2 IV on Day 1; cyclophosphamide 750 mg/m\^2 IV on Day 1 or cyclophosphamide 1000 mg/m\^2 IV on Day 1; vincristine 1.4 mg/m\^2 (up to 2 mg/m\^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5
Interventions: intervention 1: bendamustine intervention 2: rituximab intervention 3: vincristine intervention 4: prednisone intervention 5: cyclophosphamide intervention 6: doxorubicin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None

Protocol documents:
Clinical trial NCT01085318
Conditions: Multiple Sclerosis
Sponsor: EMD Serono
Start date: 2010-06-30; Completion date: 2012-03-31
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central nervous system (CNS) iron deposition, and d) immune status in subjects with relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.

Detailed description:

Arms: arm 1: Rebif 44 tiw arm 2: None
Interventions: intervention 1: Rebif
Intervention descriptions: intervention 1: 44 mcg tiw

Protocol documents:
Clinical trial NCT01326780
Conditions: Acne Vulgaris
Keywords: Acne Irritation Safety Sebum
Sponsor: Bausch Health Americas, Inc.
Start date: 2011-03-31; Completion date: 2012-03-31
Enrollment: 431 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.

Detailed description:
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.

Arms: arm 1: 1.2% JNJ 10229570-AAA arm 2: 2.4% JNJ 10229570-AAA arm 3: 3.6% JNJ 10229570-AAA arm 4: Vehicle control
Interventions: intervention 1: 1.2% JNJ 10229570-AAA intervention 2: 2.4% JNJ 10229570-AAA intervention 3: 3.6% JNJ 10229570-AAA intervention 4: Vehicle control
Intervention descriptions: intervention 1: 1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks intervention 2: 2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks intervention 3: 3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks intervention 4: Color matched cream vehicle, applied once daily to the face for 12 weeks

Protocol documents:
Clinical trial NCT00195663
Conditions: Early Rheumatoid Arthritis
Keywords: Early Rheumatoid Arthritis
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2000-12-01; Completion date: 2012-04-01
Enrollment: 799 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the safety and efficacy of adalimumab in combination with methotrexate in patients with recent onset rheumatoid arthritis (RA), and to assess the long-term safety and maintenance of efficacy after treatment with adalimumab for up to 10 years.

Detailed description:
This study had an initial 2-year double-blind treatment period followed by an 8-year open-label extension period, for a total of up to 10 years study duration. The study was designed to assess the potential of adalimumab + methotrexate to improve signs and symptoms of disease and to inhibit radiographic progression in patients with recent onset (disease duration less than 3 years) rheumatoid arthritis not previously treated with methotrexate. Adalimumab is a human anti-tumor necrosis factor (TNF) monoclonal antibody.

Arms: arm 1: Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension. arm 2: Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase. arm 3: Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
Interventions: intervention 1: Adalimumab intervention 2: Methotrexate intervention 3: Adalimumab placebo intervention 4: Methotrexate placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00363051
Conditions: Islet Cell Carcinoma Neuroendocrine Carcinoma Neuroendocrine Tumor Pancreatic Neoplasms
Keywords: Pancreatic Tumor Islet Cell Carcinoma Neuroendocrine Endocrine Atypical Carcinoid RADIANT1 RADIANT-1
Sponsor: Novartis Pharmaceuticals
Start date: 2006-06-01; Completion date: 2012-04-01
Enrollment: 160 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the efficacy and safety of everolimus in the treatment of advanced pancreatic neuroendocrine tumor (NET) not responsive to cytotoxic chemotherapy. All patients were treated with everolimus until either tumor progression was documented using a standard criteria that measures tumor size called Response Evaluation Criteria in Solid tumors (RECIST), or until unacceptable toxicity occurred, or until the patient or investigator requested discontinuation of treatment.

Detailed description:
This was a stratified two-stage, single-arm, phase 2 study of treatment with everolimus in patients with advanced (unresectable or metastatic) pancreatic neuroendocrine tumor (NET) after failure of cytotoxic chemotherapy.

Stratum 1, consisted of patients not receiving chronic Octreotide Depot therapy, will receive everolimus monotherapy at 10 mg/day.

Stratum 2, consisting of patients with tumors that have progressed during Octreotide Depot treatment will continue their entry dose of Octreotide Depot plus everolimus 10 mg/day.

Arms: arm 1: Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day.

Stratum 2 patients who were to receive everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot therapy.

Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
Interventions: intervention 1: Everolimus 10 mg intervention 2: Octreotide Depot
Intervention descriptions: intervention 1: Participants took two 5 mg tablets of Everolimus orally with a glass of water, once daily (preferably in the morning) in a fasting state or after no more than a light, fat-free meal. Dosing was to occur at the same time each day. If vomiting occurred, the vomited dose was not to be replaced. intervention 2: None

Protocol documents:
Clinical trial NCT00690430
Conditions: Symptomatic Refractory Resistant Carcinoid Disease
Keywords: Carcinoid neuroendocrine gastroenteropancreatic somatostatin analogue Symptomatic Refractory Resistant Carcinoid Disease
Sponsor: Novartis Pharmaceuticals
Start date: 2008-04-01; Completion date: 2012-04-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized, multicenter, Phase III study was to compare the efficacy of paseriotide LAR and octreotide LAR in patients whose disease-related symptoms are inadequately controlled by currently available somatostatin analogues.

Detailed description:

Arms: arm 1: Patients assigned to pasireotide LAR will receive a 60 mg dose of pasireotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 40 mg is permitted if tolerability issues arise. In addition, after 24 hours of the first LAR injections the patients were permitted to use pasireotide s.c. formulation for breakthrough symptoms as needed. arm 2: Patients assigned to octreotide LAR will receive a 40mg dose of octreotide LAR i.m. depot injection once every 28 days (+/- 3 days) for 6 months at visits 2, 4, 5, 6, 7 and 8. A dose reduction to 30 mg is permitted if tolerability issues arise. Patients requiring a dose reduction are to return to the higher dose once the tolerability issue is resolved, if required for efficacy In addition, after 24 hours of the first LAR injections the patients were permitted to use octreotide s.c. formulation for breakthrough symptoms as needed.
Interventions: intervention 1: Pasireotide intervention 2: Octreotide
Intervention descriptions: intervention 1: Pasireotide LAR 60mg i.m. injection - patients may also receive pasireotide 600 µg s.c 3 times a day for symptom control as needed intervention 2: Octreotide LAR 40mg i.m. depot injection - Patients may also receive octreotide 100 µg s.c. 3 times a day for symptom control as needed

Protocol documents:
Clinical trial NCT00699998
Conditions: Acute Coronary Syndrome
Keywords: ACS
Sponsor: Eli Lilly and Company
Start date: 2008-06-01; Completion date: 2012-04-01
Enrollment: 9326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the relative efficacy and safety of prasugrel and clopidogrel in a medically managed Unstable Angina/Non-ST-Elevation Myocardial Infarction (UA/NSTEMI) acute coronary syndrome (ACS) population (that is, patients who are not managed with acute coronary revascularization).

Detailed description:
Based upon the significant number of subjects with UA/NSTEMI ACS who are managed medically and their high risk for future cardiovascular events, further exploration of novel treatment strategies for this population, who are under-represented in large clinical trials, is warranted. Potential subjects will be those with a recent UA/NSTEMI event who are to be medically managed. Eligibility for this study will be determined by both the timing of the medical management decision and by prior commercial clopidogrel treatment at the time of randomization. The TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) Study will assess the efficacy and safety of prasugrel and aspirin compared to the current standard of care, clopidogrel and aspirin, for long-term treatment of medically managed UA/NSTEMI ACS subjects.

Arms: arm 1: Prasugrel and Low-dose Commercially-available Aspirin arm 2: Clopidogrel and Low-Dose Commercially-available Aspirin
Interventions: intervention 1: Clopidogrel intervention 2: Prasugrel intervention 3: Commercially-available Aspirin
Intervention descriptions: intervention 1: 300 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and 75 mg, oral, once daily as maintenance dose through end of study intervention 2: 30 milligrams (mg), oral, once as loading dose (in those subjects who initiate study drug with a loading dose); and either 5 mg or 10 mg (based upon weight and age), oral, once daily as maintenance dose through end of study intervention 3: Low-dose aspirin, oral, as prescribed by physician through end of study

Protocol documents:
Clinical trial NCT00883753
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2009-03-01; Completion date: 2012-04-01
Enrollment: 934 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.

Detailed description:

Arms: arm 1: Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.

Protocol documents:
Clinical trial NCT01144416
Conditions: Infertility
Keywords: Reproductive Techniques, Assisted Follicle Stimulating Hormone, Human Fertilization In Vitro
Sponsor: Organon and Co
Start date: 2010-06-01; Completion date: 2012-04-01
Enrollment: 1424 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first week of ovarian stimulation in terms of the number of vital pregnancies (ie, presence of at least one fetus with heart activity as assessed by ultrasound at least 35 days after embryo transfer) in women aged 35 to 42 years undergoing controlled ovarian stimulation (COS) prior to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Detailed description:

Arms: arm 1: Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 arm 2: Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
Interventions: intervention 1: SCH 900962 / Corifollitropin alfa / Org 36286 intervention 2: RecFSH / follitropin beta intervention 3: Placebo for SCH 900962 intervention 4: Placebo for recFSH
Intervention descriptions: intervention 1: SCH 900962 will be provided as ready-for-use prefilled syringes containing 150 μg corifollitropin alfa per 0.5 mL. On day 2 or 3 of the menstrual cycle, a single dose of 150 μg corifollitropin alfa will be administered by subcutaneous injection in the abdominal wall in the morning. intervention 2: RecFSH will be provided as a ready-for-use solution in 900 IU cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of recFSH will be done in the morning by daily injections in the abdominal wall. A starting dose of 300 IU will be administered and fixed for at least 7 days. intervention 3: Supplied as a pre-filled syringe containing an identical solution when

compared to SCH 900962, however without the active ingredient corifollitropin alfa. On Day 2 or 3 of the menstrual cycle (=Stimulation Day 1), a single dose of placebo SCH 900962 is to be administered in the morning by subcutaneous injection in the abdominal wall. intervention 4: Supplied as identical ready-for-use solution, but without the active ingredient, in cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of placebo-recFSH will be done by daily injections in the abdominal wall in the morning for a period of 7 days.

Protocol documents:
Clinical trial NCT01165684
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2010-10-01; Completion date: 2012-04-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe, and North and South America. The aim of this clinical trial is to investigate if the two treatments are equally effective.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin aspart intervention 2: insulin aspart intervention 3: insulin detemir
Intervention descriptions: intervention 1: Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c.

Doses individually adjusted. intervention 2: Insulin aspart added before each main meal. Doses individually adjusted. intervention 3: Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.

Protocol documents:
Clinical trial NCT00118248
Conditions: Recurrent Thyroid Cancer Stage IV Follicular Thyroid Cancer Stage IV Papillary Thyroid Cancer Thyroid Gland Medullary Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2004-12-01; Completion date: 2012-04-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well tanespimycin works in treating patients with inoperable locoregionally advanced or metastatic thyroid cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the 1-year treatment failure rate in patients with inoperable locoregionally advanced or metastatic medullary or differentiated thyroid carcinoma treated with 17-N-allylamino-17-demethoxygeldanamycin (17-AAG) (tanespimycin).

SECONDARY OBJECTIVES:

I. Determine the toxicity of this drug in these patients. Determine the 1-year progression-free rate in patients treated with this drug.

II. Determine the response rate and duration of response in patients treated with this drug.

III. Determine the time to treatment failure and time to subsequent therapy in patients treated with this drug.

IV. Determine the time to disease progression and overall survival of patients treated with this drug.

V. Correlate the incidence rate of RAS, RAF, and RET mutations with clinical outcome in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to type of thyroid carcinoma (medullary vs differentiated).

Patients receive tanespimycin intravenously (IV) over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.

Arms: arm 1: Patients receive tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: tanespimycin
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00157196
Conditions: Carcinoma, Non-Small-Cell Lung Lung Neoplasms
Keywords: Carcinoma, Non-Small-Cell Lung, L-BLP25, Tecemotide
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-04-01; Completion date: 2012-04-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to document the safety of tecemotide (L-BLP25) phase III formulation in non-small cell lung cancer (NSCLC) subjects with unresectable Stage III disease. This population includes Stage IIIA NSCLC subjects, a population not studied in former clinical studies with this vaccine. The secondary objective is to document the survival of subjects treated.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tecemotide (L-BLP25) intervention 2: Single low dose cyclophosphamide intervention 3: Best standard of care (BSC)
Intervention descriptions: intervention 1: After receiving single low-dose cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at weeks 0, 1, 2, 3, 4, 5, 6 and 7 followed by maintenance vaccinations (1000 mcg of tecemotide \[L-BLP25\]) at 6-week intervals, commencing at Week 13, until disease progression is documented. intervention 2: A single intravenous infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment. intervention 3: The BSC will be provided at the investigator's discretion, and may include but not be limited to psychosocial support, nutritional support and other supportive therapies.

Protocol documents: