ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00321854
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2006-05-01; Completion date: 2009-04-01
Enrollment: 535 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

Detailed description:

Arms: arm 1: Patients were treated with pramipexole for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day). arm 2: Patients were treated with placebo for 6 to 9 months then up-titrated to target dose of pramipexole (2.25 mg/day).
Interventions: intervention 1: pramipexole
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00333814
Conditions: Intermediate Uveitis Posterior Uveitis
Sponsor: Allergan
Start date: 2006-05-01; Completion date: 2009-04-01
Enrollment: 229 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

Detailed description:

Arms: arm 1: Dexamethasone 350 µg arm 2: Dexamethasone 700 µg arm 3: Sham
Interventions: intervention 1: Dexamethasone intervention 2: dexamethasone intervention 3: Sham injection
Intervention descriptions: intervention 1: Dexamethasone 350 µg; injection drug delivery system at Day 0 intervention 2: Dexamethasone 700 µg injection drug delivery system at Day 0 intervention 3: Sham injection at Day 0

Protocol documents:
Clinical trial NCT00338884
Conditions: Carcinoma, Renal Cell
Sponsor: Pfizer
Start date: 2006-09-01; Completion date: 2009-04-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase II study to allow patients with advanced kidney cancer access to sunitinib malate treatment and to find out the good and bad effects of taking 37.5 mg sunitinib malate in a continuous daily regimen (once per day) for one year.

Detailed description:

Arms: arm 1: Sunitinib malate starting dose 37.5 mg daily continuous daily schedule
Interventions: intervention 1: Sunitinib malate
Intervention descriptions: intervention 1: Sunitinib malate starting dose 37.5 mg daily continuous daily schedule

Protocol documents:
Clinical trial NCT00352755
Conditions: Peritoneal Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2006-05-01; Completion date: 2009-04-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study prospectively evaluates a multidisciplinary approach to patients with intraperitoneal carcinomatosis at Washington University. Patients with peritoneal carcinomatosis or pseudomyxoma peritonei will undergo debulking surgery with peritonectomy and placement of adhesive barrier film followed by repeated delayed intraperitoneal chemotherapy with 5FU with systemic oxaliplatin-based chemotherapy on a biweekly schedule. A retrospective review of patients treated in a similar manner at our institution showed good tolerance and efficacy. This formal Phase II study is planned to determine the safety, toxicities and survival of patients with peritoneal carcinomatosis and pseudomyxoma peritonei treated with this regimen.

Detailed description:

Arms: arm 1: * Surgical debulking with peritonectomy
* IP 5FU 600 mg/m\^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.
* FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m\^2 over 2 hours with leucovorin at 400 mg/m\^2 and IV 5-FU at 2400 mg/m\^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles.
Interventions: intervention 1: Surgical debulking with peritonectomy intervention 2: Intraperitoneal 5FU intervention 3: FOLFOX
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00356525
Conditions: Lung Neoplasms
Sponsor: Eli Lilly and Company
Start date: 2006-09-01; Completion date: 2009-04-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to help answer:

* Whether pemetrexed, gemcitabine and/or carboplatin can shrink tumor(s) or make tumor(s) disappear in patients with relapsed lung cancer (lung cancer that has come back after surgical removal and chemotherapy), and to determine how long this will last
* Whether pemetrexed, gemcitabine and/or carboplatin can help patients with relapsed lung cancer live longer

Detailed description:

Arms: arm 1: Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy arm 2: Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy arm 3: Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy arm 4: Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy
Interventions: intervention 1: pemetrexed intervention 2: gemcitabine intervention 3: carboplatin intervention 4: Pemetrexed
Intervention descriptions: intervention 1: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression intervention 2: 1500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression intervention 3: area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression intervention 4: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression

Protocol documents:
Clinical trial NCT00359801
Conditions: Diabetes Mellitus
Keywords: Large Simple Trial
Sponsor: Pfizer
Start date: 2006-07-01; Completion date: 2009-04-01
Enrollment: 1976 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of Exubera in routine clinical practice.

Detailed description:
Pfizer announced in October 2007 that it would stop marketing Exubera. At that time, Pfizer committed to continued marketing until it returned the licensing rights for the technology to Nektar. Following the announcement, enrollment was halted. Subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol. Nektar, the company from which Pfizer licensed Exubera, announced on April 9, 2008 that it had stopped its search for a new marketing partner. Accordingly, there will be no commercial availability of Exubera. As a result, an amendment was filed on April 16, 2008 specifying that all subjects randomized to Exubera had to be transitioned to usual diabetes care, and all study subjects followed for serious adverse events for 6 months. In accordance with this amendment, study A2171069 was terminated on April 29, 2009. Neither safety nor efficacy reasons were the cause of the study termination.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care intervention 2: Randomization to Exubera (insulin human [rDNA origin] inhalation powder) or Usual Diabetes Care
Intervention descriptions: intervention 1: Subjects are randomized to use Exubera. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice). Enrolling physicians are provided with the approved local label for Exubera to guide prescribing and treatment decisions. intervention 2: Subjects are randomized to use usual diabetes care. Following initial use of randomized treatment, physicians and subjects are free to change regimens and dosing based on subject response to assigned treatment (as consistent with routine practice).

Protocol documents:
Clinical trial NCT00381693
Conditions: Chronic Myeloproliferative Disorders Secondary Myelofibrosis
Keywords: primary myelofibrosis polycythemia vera essential thrombocythemia secondary myelofibrosis
Sponsor: Mayo Clinic
Start date: 2006-08-01; Completion date: 2009-04-01
Enrollment: 10 participants; Allocation: ; Intervention model: 

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of abnormal cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well azacitidine works in treating patients with myelofibrosis.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy of azacitidine in patients with myelofibrosis (MF) with myeloid metaplasia.
* Evaluate the safety of azacitidine in these patients. Secondary
* Evaluate pertinent biologic characteristics of MF before and during therapy with azacitidine.
* Assess the effects of study treatment on constitutional symptoms in these patients.
* Estimate time to event distributions for overall survival and progression. OUTLINE: Patients receive azacitidine subcutaneously once daily on days 1-5. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 3 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Interventions: intervention 1: azacitidine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00384449
Conditions: Eales' Disease
Keywords: Eales
Sponsor: Oregon Health and Science University
Start date: 2006-10-01; Completion date: 2009-04-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe and effective when used for macular edema (retinal swelling) due to Eales' disease. The secondary objective is to see if macular edema comes back within three months after the last dose of study drug is given.

Detailed description:
This is a six-month study. Eligible subjects will receive one injection of the study drug into one eye for each of three months. Visual acuity, blood pressure and eye pressure will be tested. Subjects' retinas will be examined and thickness measured by optical coherence tomography (OCT). Safety visits will be scheduled for the week after the injections. The investigators will monitor the subjects' eyes for infection and inflammation. After the three-month treatment period, subjects will return to the clinic monthly for four follow-up visits. Procedures and tests that will be performed at the follow-up visits include visual acuity, a retinal exam including OCT, blood pressure, and eye pressure.

Arms: arm 1: Lucentis (ranibizumab)
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months

Protocol documents:
Clinical trial NCT00397189
Conditions: Primary Insomnia
Keywords: Primary insomnia as defined by DSM IV criteria
Sponsor: Neurim Pharmaceuticals Ltd.
Start date: 2006-10-01; Completion date: 2009-04-01
Enrollment: 930 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, placebo controlled study to evaluate the efficacy of a 3 week treatment period with Circadin® 2 mg in shortening sleep latency in patients with primary insomnia aged 18-80 with melatonin deficiency.

Detailed description:
Studies throughout the world have shown that insomnia is a common complaint that occurs in 10-50% of the population depending on age, sex and country. Among the wide variety of available treatments of sleep disturbances, the most commonly prescribed hypnotics are the benzodiazepines (BZD) and non-BZD hypnotics.

However, these hypnotics were often associated with rebound, dependency, tolerance, higher risk of falls mainly in the elderly population, anterograde memory disturbances and increased risk for motor accidents the next day.

In response to the unmet clinical need for a safe and efficacious alternative treatment for primary insomnia, that in addition to treating quantitative sleep problems, would improve sleep quality and daytime functioning, a clinical development program on melatonin for the treatment of primary insomnia was initiated.

This study is conducted using a randomised, double-blind, placebo controlled parallel group design, after a single-blind placebo period. Primary insomnia patients aged 18-80 will be screened for entry into the study.

After the initial 3 weeks double-blind treatment period, patients will be given the option to enter a six-month double-blind continuation study.

Primary parameter is sleep latency, secondary parameter is sleep maintenance. Exploratory parameters are total sleep time, sleep quality, morning alertness and quality of life.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Circadin intervention 2: placebo circadin
Intervention descriptions: intervention 1: Prolonged release melatonin 2 mg intervention 2: placebo circadin tablets

Protocol documents:
Clinical trial NCT00398632
Conditions: Depression
Sponsor: Stanford University
Start date: 2006-11-01; Completion date: 2009-04-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia who are being treated with an SSRI and experiencing treatment-related sexual dysfunction will experience less sexual dysfunction if they are switched to duloxetine, and 2. they will experience either improved antidepressant response or no loss of antidepressant response.

Detailed description:
In this study, subjects suffering from depression or dysthymia and experiencing treatment-emergent sexual dysfunction from an SSRI are switched from their SSRI to duloxetine to determine whether or not they experience improved sexual function and equal or improved antidepressant response. Study subjects are assigned to receive open label duloxetine for 12 weeks at either 60mg per day or 120mg per day after discontinuing their current antidepressant

Arms: arm 1: Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks

Protocol documents:
Clinical trial NCT00420784
Conditions: Hepatitis C
Keywords: Genotype 1
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2007-02-01; Completion date: 2009-04-01
Enrollment: 465 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

Detailed description:

Arms: arm 1: Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 24 weeks. arm 2: Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. arm 3: Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks. arm 4: Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks.
Interventions: intervention 1: Telaprevir intervention 2: Ribavirin intervention 3: Pegylated Interferon Alfa 2a intervention 4: Matching Placebo
Intervention descriptions: intervention 1: tablet intervention 2: tablet intervention 3: Solution for injection intervention 4: Tablet

Protocol documents:
Clinical trial NCT00427635
Conditions: GERD
Keywords: neonates infants GERD reflux
Sponsor: AstraZeneca
Start date: 2006-10-01; Completion date: 2009-04-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.

Detailed description:

Interventions: intervention 1: Esomeprazole
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00428597
Conditions: Carcinoma, Islet Cell Carcinoma, Pancreas
Sponsor: Pfizer
Start date: 2007-06-01; Completion date: 2009-04-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study randomized patients with advanced pancreatic islet cell tumors to receive either sunitinib or placebo. Patients who were randomized to sunitinib received 37.5 mg of sunitinib daily, those randomized to placebo received a tablet that looked similar but had no active drug. Neither the patient or the doctor knew whether the patient was receiving sunitinib or placebo. Patients were followed to determine the status and size of their tumors, survival, quality of life and safety of the drug.

The study was designed to detect a 50% improvement in median PFS\[Progression Free Survival\] with 90% power and was to enroll 340 subjects. An interim analysis was planned when 130 events had occurred, and the final analysis was to be conducted when 260 events had occurred.

Study A6181111 was stopped early during the enrollment period because of a clear and clinically meaningful improvement in efficacy for the sunitinib treatment arm as recommended by the DMC \[Data Monitoring Committee\]. The actual number of subjects enrolled was 171 and the actual number of PFS events recorded was 81 PFS events. The decision to terminate the study was not based on safety concerns related to sunitinib administration.

Detailed description:
The study was terminated on 11 March 2009 because the independent Data Monitoring Committee determined that the study had met its primary endpoint in demonstrating improvement in progression-free survival. The decision to terminate the trial was not based on safety concerns related to sunitinib administration.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sunitinib malate intervention 2: Placebo
Intervention descriptions: intervention 1: * sunitinib malate oral starting dose 37.5 mg daily (continuous dosing).
* Dose may be decreased to 25 mg daily in case of adverse events.
* It may be increased to 50 mg daily if no response is seen after 8 weeks on treatment.
* Dosing to continue until unacceptable toxicity, progression of disease, death, or study termination. intervention 2: Placebo to match sunitinib taken daily (oral) on the same schedule as active agent below.

Protocol documents:
Clinical trial NCT00434252
Conditions: Melanoma
Keywords: Avastin BEAM Metastatic melanoma
Sponsor: Genentech, Inc.
Start date: 2007-02-01; Completion date: 2009-04-01
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Phase II, multicenter, randomized, double-blind, placebo-controlled trial was designed to estimate the efficacy and characterize the safety of bevacizumab when combined with carboplatin + paclitaxel chemotherapy compared with carboplatin + paclitaxel chemotherapy alone in patients with previously untreated metastatic melanoma.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bevacizumab intervention 2: carboplatin intervention 3: paclitaxel intervention 4: placebo
Intervention descriptions: intervention 1: 15 mg/kg by intravenous (IV) infusion on the first day of each 3-week cycle (dose was based on patient's weight at screening and remained the same throughout study) intervention 2: Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 3-week cycle, for a maximum of 10 cycles intervention 3: 175 mg/m\^2 by IV infusion on the first day of each 3-week cycle (dose was based on patient's weight and could be adjusted for weight change) intervention 4: Administered by IV infusion on the first day of each 3-week cycle

Protocol documents:
Clinical trial NCT00443729
Conditions: HIV Infection
Keywords: treatment experienced
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-05-01; Completion date: 2009-04-01
Enrollment: 355 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy, safety, and tolerability of an investigational treatment for patients with Human Immunodeficiency Virus (HIV).

Detailed description:

Arms: arm 1: Raltegravir \& Placebo arm 2: Lopinavir (+) Ritonavir \& Placebo
Interventions: intervention 1: Comparator: raltegravir intervention 2: Comparator: placebo intervention 3: Comparator: lopinavir (+) ritonavir intervention 4: Comparator: placebo
Intervention descriptions: intervention 1: raltegravir 400 milligram (mg) by mouth (PO) twice daily (b.i.d) for up to 48 weeks of treatment intervention 2: lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment intervention 3: lopinavir (+) ritonavir 400/100 mg by mouth (PO) twice daily (b.i.d.) for up to 48 weeks of treatment intervention 4: raltegravir 400 mg by mouth (PO) twice daily (b.i.d.) Placebo for up to 48 weeks of treatment

Protocol documents:
Clinical trial NCT00447876
Conditions: Chronic Plantar Fasciitis
Sponsor: Ipsen
Start date: 2005-07-01; Completion date: 2009-04-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the hypothesis that the analgesic effect of a single injection of Dysport (200 MU) induces a significant reduction of symptoms in chronic cases of plantar fasciitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Botulinum toxin type A intervention 2: Placebo
Intervention descriptions: intervention 1: Botulinum type A toxin (Dysport®): 200 Units injected at the root of the plantar fascia intervention 2: 0.9% sodium chloride: 2 ml injected at the root of the plantar fascia

Protocol documents: