ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00234052
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer
Sponsor: Northwestern University
Start date: 2005-07-28; Completion date: 2011-11-28
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the median time to disease progression in patients with stage IIIB or IV or recurrent non-squamous cell non-small cell lung cancer treated with carboplatin, pemetrexed disodium, and bevacizumab.

Secondary

* Determine the response rate and duration of response in patients treated with this regimen.
* Determine the toxic effects of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with complete response, partial response, or stable disease continue to receive pemetrexed disodium and bevacizumab in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Arms: arm 1: Carboplatin + pemetrexed + bevacizumab
Interventions: intervention 1: bevacizumab intervention 2: carboplatin intervention 3: pemetrexed
Intervention descriptions: intervention 1: 5 mg/kg administered intravenously over 90 minutes on day 1 of each cycle (cycle = 3 weeks) intervention 2: Administered intravenously at a dose of AUC=6 over 30 minutes on day 1 of each cycle (1 cycle = 3 weeks) intervention 3: Administered intravenously at a dose of 500 mg/m2 over 10 minutes on day 1 of each cycle (1 cycle = 3 weeks)

Protocol documents:
Clinical trial NCT00545103
Conditions: Diverticulitis
Sponsor: Shire
Start date: 2007-12-06; Completion date: 2011-11-28
Enrollment: 592 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SPD476, MMX™ mesalazine, 1.2g extended release tablet intervention 2: SPD476, MMX™ mesalazine, 2.4g extended release tablet intervention 3: SPD476, MMX™ mesalazine, 4.8g extended release tablet intervention 4: Placebo
Intervention descriptions: intervention 1: SPD476 1.2g administered Once Daily (QD) intervention 2: SPD476 2.4g administered Once Daily (QD) intervention 3: SPD476 4.8g administered Once Daily (QD) intervention 4: Placebo administered Once Daily (QD)

Protocol documents:
Clinical trial NCT01246583
Conditions: Psoriasis
Keywords: Multi Site Randomized Placebo Controlled Double Blind Parallel Group chronic plaque psoriasis topical treatment skin diseases papulosquamous
Sponsor: Pfizer
Start date: 2011-02-16; Completion date: 2011-11-29
Enrollment: 71 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CP-690,550 Ointment 1 intervention 2: Vehicle 1 intervention 3: CP-690,550 Ointment 2 intervention 4: Vehicle 2
Intervention descriptions: intervention 1: 2% CP-690,550 Ointment 1 twice daily for 4 weeks intervention 2: Vehicle 1 twice daily for 4 weeks intervention 3: 2% CP-690,550 Ointment 2 twice daily for 4 weeks intervention 4: Vehicle 2 twice daily for 4 weeks

Protocol documents:
Clinical trial NCT01323855
Conditions: Parkinson Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-03-28; Completion date: 2011-11-29
Enrollment: 46 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a two part study to compare the PK of preladenant administered to participants with CRI to the PK of preladenant administered to healthy participants. Part 1 will compare the PK of participants with severe CRI to healthy participants. Part 2 will compare the PK of participants with moderate CRI and participants with mild CRI to healthy participants. The primary hypotheses are that the plasma area under the concentration-time curve from time 0 to infinity after single dosing (AUC0-∞) of preladenant in participants with either severe, moderate or mild CRI is similar to that of matched healthy participants.

Detailed description:

Arms: arm 1: Participants with severe CRI, defined as creatinine clearance of \<30 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally arm 2: Participants with moderate CRI defined as creatinine clearance of ≥30 and \<50 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally arm 3: Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m\^2, were treated with a single tablet of 5 mg preladenant, administered orally arm 4: Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally arm 5: Participants with normal renal function, defined as creatinine clearance of \>80 mL/min/1.73 m\^2, were treated with a single tablet of 5 mg preladenant, administered orally
Interventions: intervention 1: Preladenant
Intervention descriptions: intervention 1: After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally

Protocol documents:
Clinical trial NCT01055067
Conditions: Non-CNS Germ Cell Tumors (Seminomas and Nonseminomas)
Sponsor: Daiichi Sankyo
Start date: 2010-02-02; Completion date: 2011-11-30
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, single-arm study for safety and efficacy.

Detailed description:

Arms: arm 1: 3 capsules of 120 mg each, administered twice a day (once in the morning and once in the evening - total daily dose of 720 mg) in continuous 4-week cycles
Interventions: intervention 1: Tivantinib (ARQ 197)
Intervention descriptions: intervention 1: Capsule, 120 mg, BID (360 mg), approximately 112 days

Protocol documents:
Clinical trial NCT00069784
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Keywords: Impaired Fasting Glucose (IFG) Impaired Glucose Tolerance (IGT)
Sponsor: Sanofi
Start date: 2003-08-01; Completion date: 2011-12-01
Enrollment: 12537 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.

Detailed description:
The ORIGIN study was conducted by the Population Health Research Institute in Hamilton, Ontario (Canada), working in conjunction with the sponsor, and an independent Steering Committee.

Routine visits were to occur at 2, 4, 8, and 16 weeks following randomization, then every four months for the rest of the study, for all participants

The duration of the study was based on the number of events observed (event-driven study) and was originally planned to be 5 years. In 2008-2009 ORIGIN's follow-up was extended by approximately 2 years, because of published literature of completed studies suggesting that a longer period of effective glycemic contrast between treatments might be needed to see an effect on cardiovascular events.

Arms: arm 1: * Insulin glargine once daily by subcutaneous injection in a titrated regimen targeting a fasting plasma glucose (FPG) level of ≤95 mg/dL (5.3 mmol/L)
* One capsule of omega-3 polyunsaturated fatty acids once daily arm 2: * Insulin glargine once daily by subcutaneous injection in a titrated regimen targeting a fasting plasma glucose (FPG) level of ≤95 mg/dL (5.3 mmol/L)
* One capsule of placebo once daily arm 3: • One capsule of omega-3 polyunsaturated fatty acids once daily arm 4: • One capsule of placebo once daily
Interventions: intervention 1: insulin glargine (HOE901) intervention 2: omega-3 polyunsaturated fatty acids (PUFA) intervention 3: placebo intervention 4: reusable pen device for insulin injection
Intervention descriptions: intervention 1: Cartridges for use in a pen device, each containing 3 mL of insulin glargine 100 U/mL solution for injection intervention 2: Gelatin capsules (containing icosapent ethyl esters 465 mg and doconexent ethyl esters 375 mg) for oral administration intervention 3: Matching placebo gelatin capsules (containing olive oil) for oral administration intervention 4: None

Protocol documents:
Clinical trial NCT00259740
Conditions: Relapsed or Plateau-Phase Multiple Myeloma
Keywords: Multiple Myeloma, Relapsed, Plateau-Phase
Sponsor: Amgen
Start date: 2005-11-01; Completion date: 2011-12-01
Enrollment: 96 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.

Detailed description:
Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are limited and may include best supportive care and investigational therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without further tumor regression despite continued treatment. Recent evidence suggests that their prognosis might improve with further reduction in serum M-protein or prolongation of time to disease progression (TTP). These patients are candidates for investigational agents that could further reduce tumor burden or increase TTP.

Arms: arm 1: None
Interventions: intervention 1: DENOSUMAB
Intervention descriptions: intervention 1: 120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.

Protocol documents:
Clinical trial NCT00439777
Conditions: Pulmonary Embolism
Sponsor: Bayer
Start date: 2007-03-01; Completion date: 2011-12-01
Enrollment: 4833 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic pulmonary embolism (PE) with or without symptomatic Deep-Vein Thrombosis (DVT) (Einstein-PE).

Detailed description:
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Arms: arm 1: Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.) arm 2: Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin overlapping with and followed by VKA
Intervention descriptions: intervention 1: During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food. intervention 2: Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 hr before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.

Protocol documents:
Clinical trial NCT00451958
Conditions: Prostate Cancer
Keywords: Degarelix prostate cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2007-03-01; Completion date: 2011-12-01
Enrollment: 386 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Participants who completed the FE200486 CS21 study (NCT00295750) could enter the FE200486 CS21A study. The study continued until all non-discontinued participants had received treatment for at least 5 years.

Detailed description:

Arms: arm 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study. arm 2: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.

Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. arm 3: During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.

Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.

Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study. arm 4: During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.

Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.

Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study.
Interventions: intervention 1: Degarelix 80 mg / Degarelix 80 mg intervention 2: Degarelix 160 mg / Degarelix 160 mg intervention 3: Leuprolide 7.5 mg / Degarelix 80 mg intervention 4: Leuprolide 7.5 mg / Degarelix 160 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00526474
Conditions: Atherosclerosis Ischemia Myocardial Infarction Cerebrovascular Accident Peripheral Arterial Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-09-01; Completion date: 2011-12-01
Enrollment: 26449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to determine whether vorapaxar, when added to the existing standard of care (SOC) for preventing heart attack and stroke (eg, aspirin, clopidogrel) in participants with a known history of atherosclerosis, will yield additional benefit over the existing standard of care without vorapaxar in preventing heart attack and stroke.

The study is also designed to assess risk of bleeding with vorapaxar added to the standard of care versus the standard of care alone.

Detailed description:

Arms: arm 1: 1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care. arm 2: one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
Interventions: intervention 1: Vorapaxar intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5-mg tablet daily for at least 1 year intervention 2: matching tablet daily for at least 1 year

Protocol documents:
Clinical trial NCT01034462
Conditions: Major Depressive Disorder
Keywords: Depression Major Depressive Disorder
Sponsor: Forest Laboratories
Start date: 2009-12-01; Completion date: 2011-12-01
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder

Detailed description:

Arms: arm 1: Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. arm 2: Matching placebo capsules, oral administration, once daily dosing.
Interventions: intervention 1: Levomilnacipran ER intervention 2: Placebo
Intervention descriptions: intervention 1: Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing. Study drug is to be given orally, in capsule form, once daily, for 8 weeks intervention 2: Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.

Protocol documents:
Clinical trial NCT01235442
Conditions: Psoriasis
Keywords: Psoriasis Topical etanercept clobetasol propionate
Sponsor: Amgen
Start date: 2010-09-01; Completion date: 2011-12-01
Enrollment: 592 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.

Detailed description:

Arms: arm 1: Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24) arm 2: Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks
Interventions: intervention 1: 1=Etanercept intervention 2: 2=Clobetasol propionate foam
Intervention descriptions: intervention 1: 50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks. intervention 2: 0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses

Protocol documents:
Clinical trial NCT01326026
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-03-01; Completion date: 2011-12-01
Enrollment: 222 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) once daily in insulin naïve subjects with type 2 diabetes mellitus when titrated using two different self-titration algorithms (dose individually adjusted) in combination with metformin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: insulin degludec intervention 2: insulin degludec
Intervention descriptions: intervention 1: Injected subcutaneously (under the skin) once daily. Dose individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.

Protocol documents:
Clinical trial NCT01355458
Conditions: Rosacea
Keywords: rosacea
Sponsor: Galderma R&D
Start date: 2011-05-01; Completion date: 2011-12-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CD07805/47 gel intervention 2: Placebo
Intervention descriptions: intervention 1: applied topically once daily intervention 2: applied topically once daily

Protocol documents:
Clinical trial NCT01427803
Conditions: Pain
Keywords: Actual Use Trial
Sponsor: Bayer
Start date: 2011-09-01; Completion date: 2011-12-01
Enrollment: 778 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Naproxen Sodium ER (BAYH6689)
Intervention descriptions: intervention 1: BAYH6689; oral tablet used as needed upon incidence of pain

Protocol documents: