ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00513071
Conditions: Hormone-resistant Prostate Cancer Recurrent Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-08-01; Completion date: 2008-10-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well AZD0530 works in treating patients with prostate cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed description:
PRIMARY OBJECTIVES:

I. To test the hypothesis that AZD0530 will improve the prostate-specific antigen (PSA) response rate and progression-free survival (PFS) in comparison with historical controls for patients with hormone-refractory prostate cancer (HRPC).

II. Evaluate the time to treatment failure and overall survival of patients with HRPC treated with AZD0530.

III. Evaluate the toxicities and tolerance of AZD0530 therapy in the HRPC population.

OUTLINE: This is a multicenter study.

Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 6 months for the first 2 years and then yearly thereafter.

Arms: arm 1: Patients receive oral AZD0530 once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: saracatinib intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given orally intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00519090
Conditions: Myelogenous Leukemia
Keywords: leukemia bone marrow leukemia symptoms cml complete blood count lymphocyte blood cancer leukocytes chronic leukemia bone marrow biopsy leukemia research leukemia cells bone marrow disease chronic myeloid leukemia blood cancer symptoms white blood cell diseases chronic myelogenous leukemia leukemia treatment leukemia facts leucemia facts about leukemia myelogenous leukemia newly diagnosed CML suboptimal response Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)
Sponsor: Novartis Pharmaceuticals
Start date: 2007-10-01; Completion date: 2008-10-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

Detailed description:
This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to \< 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to \< 18 months and having partial cytogenetic response (PCyR), but no CCyR.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Imatinib intervention 2: Nilotinib (AMN107)
Intervention descriptions: intervention 1: Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days. intervention 2: Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.

Protocol documents:
Clinical trial NCT00520494
Conditions: Common Variable Immunodeficiency Agammaglobulinemia
Keywords: Previously Untreated Patient (PUP) Primary Immunodeficiency (PID) CVID XLA Subcutaneous immunoglobulin (SCIG) IgG trough level Quality of life Common variable immunodeficiency (CVID) X-linked agammaglobulinemia (XLA)
Sponsor: CSL Behring
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

Detailed description:

Arms: arm 1: Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
Interventions: intervention 1: Vivaglobin
Intervention descriptions: intervention 1: Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

Protocol documents:
Clinical trial NCT00527787
Conditions: Gastric Ulcer
Keywords: NSAID gastric ulcers Vimovo Naproxen Esomeprazole
Sponsor: POZEN
Start date: 2007-09-01; Completion date: 2008-10-01
Enrollment: 434 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study uses a randomized, double-blind, controlled design to demonstrate that PN400 (esomeprazole and naproxen) is more effective in reducing the occurrence of gastroduodenal ulcers, dyspepsia, and heartburn in subjects at risk for developing NSAID-associated gastric ulcers compared to naproxen alone.

Detailed description:
Objectives:

Primary: To demonstrate that PN400 is effective in reducing the risk of gastric ulcers in subjects at risk for developing NSAID-associated gastric ulcers.

Secondary:

* To determine if PN400 is effective in reducing the risk of duodenal ulcers in subjects at risk for developing NSAID-associated ulcers
* To compare upper gastrointestinal symptoms in subjects treated with PN400 versus naproxen as measured by scores on the Severity of Dyspepsia Assessment (SODA) instrument and the Overall Treatment Evaluation - Dyspepsia (OTE-DP)
* To compare heartburn symptoms in subjects treated with PN400 versus naproxen
* To evaluate the safety and tolerability of PN400 and naproxen

Arms: arm 1: Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily arm 2: Naproxen 500 mg dosed twice daily
Interventions: intervention 1: PN400 (VIMOVO) intervention 2: Naproxen
Intervention descriptions: intervention 1: PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally. intervention 2: Naproxen (500 mg) dosed twice daily (bid) orally

Protocol documents:
Clinical trial NCT00530621
Conditions: Non-small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-09-01; Completion date: 2008-10-01
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination of enzastaurin and pemetrexed can extend survival time without progression of disease for participants who have advanced or metastatic non-small cell lung cancer (NSCLC).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: enzastaurin intervention 2: placebo intervention 3: pemetrexed
Intervention descriptions: intervention 1: 1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression intervention 2: oral, daily intervention 3: 500 milligrams per square meter (mg/m\^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression

Protocol documents:
Clinical trial NCT00545779
Conditions: Post-Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2006-12-01; Completion date: 2008-10-01
Enrollment: 677 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess participant preference for monthly Bonviva, versus daily or weekly alendronate or risedronate, in the treatment of postmenopausal osteoporosis. Participants currently on a daily or weekly regimen of bisphosphonate therapy (alendronate or risedronate) will answer a questionnaire to identify participants who may benefit from a monthly Bonviva regimen. Eligible participants will then discontinue their present bisphosphonate treatment, and switch to monthly Bonviva 150mg per oral (po). At the beginning and end of Bonviva treatment, all participants will complete an Osteoporosis Patient Satisfaction Questionnaire. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
Interventions: intervention 1: Ibandronate
Intervention descriptions: intervention 1: 150 mg orally once monthly for 6 months

Protocol documents:
Clinical trial NCT00555438
Conditions: Major Orthopaedic Surgery and Renal Impairment
Keywords: major orthopaedic surgery venous thromboembolic events prevention renal impairment Arixtra anti-Xa activity
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 451 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Fondaparinux is an antithrombotic agent having already received a regulatory approval by the European Authorities in venous thromboembolic event prevention after major orthopaedic surgery, as total hip replacement (THR), total knee replacement (TKR), hip fracture (HF). The bleeding risk associated with this prescription is highly related to renal function evaluated by creatinin clearance (CrCl). In order to reduce the bleeding risk, it has been proposed to prescribe fondaparinux 1.5 mg/day in patients with a CrCl between 20 and 50ml/mn instead of 2.5mg/day (European MMA). In the meantime, this approval is essentially based on simulated pharmakinetic data without any support of clinical data.

prospective, multicentre, open-label study evaluating the safety profile of fondaparinux 1.5 mg/day, subcutaneously administered, in patients with a renal impairment defined by a CrCl between 20 and 30 ml/min and undergoing a major orthopaedic surgery.

Detailed description:
Fondaparinux 1.5mg/day subcutaneously administered during post-surgery 1 to 10 days with the 1st treatment administration performed 6 to 8 hours after the end of surgery.

Screening visit : \> 7 days before inclusion visit if THR and TKR Inclusion visit : day of surgery Visits with blood drawing: 3 visits scheduled during 1 to 10 days of treatment period Study end of treatment visit: D1 to D10 Study end visit: 1 month ± 15 days

Arms: arm 1: patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
Interventions: intervention 1: fondaparinux 1.5 mg/day
Intervention descriptions: intervention 1: Subcutaneous injection of fondaparinux 1.5 mg/l after major orthopaedic surgery

Protocol documents:
Clinical trial NCT00565669
Conditions: Dry Eye Syndrome
Keywords: Treatment Dry Eye
Sponsor: Medical University of South Carolina
Start date: 2007-10-01; Completion date: 2008-10-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Blink Tears and Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

Detailed description:
Dry eye is a chronic condition that is believed to afflict more than 3 million patients in the United States.1 Symptoms of dry eye are very bothersome and impact quality of life, reduce work capacity, and may result in poorer psychological health. Also, symptoms of dry eye are associated with a decreased ability to perform activities that require visual attention such as reading and driving a car.2 Patients with dry eye complain most frequently of a scratchy or sandy (foreign body) sensation. Other common symptoms are itching, excessive mucus secretion, inability to produce tears, a burning sensation, photosensitivity, redness, pain, and difficulty in moving the lids. In most patients, the most remarkable feature of the eye examination is the grossly normal appearance of the eye.3 Chronic dry eye disease is associated with an inflammatory mechanism mediated by activated T-cell lymphocytes3 which affects the ocular surface and lacrimal gland.4 The damage caused by dry eye disease may be irreversible, and despite the availability of various tear substitutes, many patients with dry eye syndrome experience corneal injuries with a subsequent reduction in vision.5 Cyclosporin A (Restasis®, Allergan, Irvine, CA) has been shown to significantly reduce the number of activated T-lymphocytes within the conjunctiva6, thereby minimizing the inflammation causing dry eye. Topical cyclosporin A 0.05% ophthalmic emulsion (Restasis®, Allergan, Irvine, CA) increases tear production and improves the quality of naturally produced tears and is the first approved therapeutic agent for the treatment of chronic dry eye and the only treatment modality that addresses the underlying pathology.

In addition to topical therapy with cyclosporine, some patients continue to use artificial tears for occasional relief of residual symptoms. The choice of concomitant tear is important but little research has been published differentiating between the efficacy of these solutions when used concomitantly with topical cyclosporine.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cyclosporin A Restasis® intervention 2: Blink tears intervention 3: Systane
Intervention descriptions: intervention 1: None intervention 2: blink tears to be used twice a day intervention 3: systane to be used twice a day

Protocol documents:
Clinical trial NCT00575367
Conditions: Bacterial Infections Eye Infections
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-03-01; Completion date: 2008-10-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AzaSite (azithromycin ophthalmic solution) intervention 2: Vigamox (moxifloxacin hydrochloride ophthalmic solution)
Intervention descriptions: intervention 1: One drop ophthalmic solution at Visit 2 intervention 2: One drop ophthalmic solution at Visit 2

Protocol documents:
Clinical trial NCT00589979
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis Knee Lidoderm Lidocaine Topical patch Adjunct therapy
Sponsor: Endo Pharmaceuticals
Start date: 2007-03-01; Completion date: 2008-10-01
Enrollment: 169 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Patients with knee pain due to Osteoarthritis (OA) experiencing sub-optimal pain relief from their current analgesic regimen will participate in a pilot clinical trial to evaluate the effectiveness and tolerability of the Lidoderm Patch compared with placebo in treating knee pain from OA.

Detailed description:

Arms: arm 1: Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) arm 2: Placebo Patch 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h)
Interventions: intervention 1: Lidoderm (Lidocaine 5% Patch) intervention 2: Placebo Patch
Intervention descriptions: intervention 1: Topical Patch intervention 2: Topical Patch

Protocol documents:
Clinical trial NCT00591214
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C Protease Inhibitor
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-12-01; Completion date: 2008-10-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MP-424 (Telaprevir)
Intervention descriptions: intervention 1: Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)

Protocol documents:
Clinical trial NCT00594308
Conditions: Acute Myelogenous Leukemia Acute Lymphocytic Leukemia Chronic Myelogenous Leukemia Chronic Lymphocytic Leukemia Myelodysplasia Lymphoma, Non-Hodgkin's Mantle-Cell Lymphoma Hodgkin's Disease Multiple Myeloma Myelofibrosis
Sponsor: Indiana University
Start date: 2007-10-01; Completion date: 2008-10-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine with cyclosporine alone for the prevention of graft-versus-host disease.

This research is being done because there is no completely safe and effective prevention for graft-versus-host disease. It is known that cyclosporine helps with GVHD but we would like to know if the addition of basiliximab will decrease the incidence and/or severity of GVHD after a transplant known as nonmyeloablative ("mini" transplant).

Detailed description:

Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Cyclosporine intervention 4: Mycophenolate mofetil intervention 5: Basiliximab
Intervention descriptions: intervention 1: 60mg/kg/day for two consecutive days (-7,-6). intervention 2: 25mg/m2/day for 5 consecutive days intervention 3: 3mg/kg/day will be given by continuous intravenous infusion beginning on Day -1. intervention 4: 1000 mg will be administered through day +60 and then discontinued if there is no GVHD. intervention 5: 20mg , will be given by intravenous infusion (without an in-line filter) over at least 15 minutes beginning 3 days after engraftment.

Protocol documents:
Clinical trial NCT00595231
Conditions: Generalized Anxiety Disorder
Keywords: GAD
Sponsor: Biotie Therapies Inc.
Start date: 2008-03-01; Completion date: 2008-10-01
Enrollment: 239 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Multi-Centered Randomized, Double-Blind, Placebo-Controlled, Phase 2, Exploratory Study to Evaluate the Effect of Rufinamide on Anxiety in Patients with Moderate to Severe Generalized Anxiety Disorder.

Detailed description:
This was an exploratory study to evaluate the effect of 500 or 1000 mg per day for 8 weeks of Rufinamide compared to placebo on measures of anxiety in patients with Generalized Anxiety Disorder, and to determine tolerability of Rufinamide in this population.

Arms: arm 1: 500 mg 1 week, followed by 1000 mg for 7 weeks arm 2: 0 mg tablets
Interventions: intervention 1: SYN111 intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mg for 1 week followed by 1000 mg for 7 weeks intervention 2: 0 mg tablets

Protocol documents:
Clinical trial NCT00606684
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Chronic Obstructive Pulmonary Disease (COPD) COPD GW642444
Sponsor: GlaxoSmithKline
Start date: 2008-02-01; Completion date: 2008-10-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)

Detailed description:

Arms: arm 1: GW642444 arm 2: None
Interventions: intervention 1: GW642444 6.25 intervention 2: GW642444 3mcg intervention 3: GW642444 12.5mcg intervention 4: GW642444 25mcg intervention 5: GW642444 50mcg intervention 6: placebo
Intervention descriptions: intervention 1: GW642444 6.25 intervention 2: once daily intervention 3: GW642444 12.5mcg intervention 4: GW642444 25mcg intervention 5: GW642444 50mcg intervention 6: placebo

Protocol documents:
Clinical trial NCT00608023
Conditions: Lipodystrophy HIV Infections
Keywords: HIV Lipodystrophy Abdominal fat accumulation Growth hormone releasing hormone HIV-associated lipodystrophy Treatment experienced
Sponsor: Theratechnologies
Start date: 2007-08-01; Completion date: 2008-10-01
Enrollment: 263 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

Detailed description:
HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.

Arms: arm 1: Tesamorelin 2 mg/day for 12 months arm 2: Tesamorelin 2 mg/day for 6 months - Placebo for 6 months arm 3: Placebo 6 months - Tesamorelin 2 mg/day for 6 months
Interventions: intervention 1: Tesamorelin intervention 2: Placebo for Tesamorelin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00612534
Conditions: Post Operative Pain
Sponsor: Talphera, Inc
Start date: 2008-03-01; Completion date: 2008-10-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate three different dosage strengths of sublingual ARX-F01 (Sufentanil NanoTab) versus a sublingual Placebo NanoTab for the treatment of post-operative pain in subjects following total knee replacement surgery. We hypothesize that subjects receiving placebo will have poor pain relief and will drop out of the study sooner and more often than the ARX-F01-treated subjects.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Sufentanil NanoTab intervention 2: Placebo NanoTab intervention 3: Sufentanil NanoTab intervention 4: Sufentanil NanoTab
Intervention descriptions: intervention 1: 5 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 2: Placebo NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 3: 10 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours intervention 4: 15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for pain for 12 hours

Protocol documents: