ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00754923
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: Ohio State University Comprehensive Cancer Center
Start date: 2008-10-01; Completion date: 2012-04-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sorafenib works in treating non-smokers or former light smokers with relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the efficacy of sorafenib tosylate, in terms of 6-month progression-free survival rate, in non-smokers or former light smokers with relapsed or refractory stage IIIB or IV non-small cell lung cancer.

Secondary

* To determine the 1-year survival rate in patients treated with this drug.
* To assess the frequency and severity of adverse events associated with this drug in these patients.
* To investigate the mutational status of EGFR (epidermal growth factor receptor), ALK (anaplastic lymphoma kinase), ROS1, and K-Ras(Kirsten rat sarcoma viral oncogene homolog)in archived tumor samples from these patients.

OUTLINE: Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples are analyzed for mutations of EGFR, ALK, ROS1, and K-Ras by PCR (polymerase chain reaction) and DNA (deoxyribonucleic acid) sequencing.

After completion of study treatment, patients are followed every 3 months.

Arms: arm 1: Sorafenib will be administered at a dose of 400 mg taken twice daily, continuously on a 28 day cycle.
Interventions: intervention 1: sorafenib
Intervention descriptions: intervention 1: administered orally at 400 mg taken twice daily , continuously on a 28 day cycle as an outpatient.

Protocol documents:
Clinical trial NCT00779103
Conditions: Central Precocious Puberty
Keywords: puberty precocious puberty early puberty early onset puberty histrelin histrelin subcutaneous implant implant therapy
Sponsor: Endo Pharmaceuticals
Start date: 2004-09-01; Completion date: 2012-04-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to follow and collect additional medical and developmental information on children after histrelin subcutaneous implant therapy is discontinued.

Detailed description:
Thirty-two (32) patients will receive a histrelin subdermal implant under the anesthesia deemed appropriate by the administering physician. Ten-twelve (10-12) sites will enroll 2-3 patients per site. It is anticipated that half the patients will be receiving GnRH analog treatment and the other half will be treatment naïve. All patients will undergo selective PK sampling post-implantation to assess histrelin profile. At 12 months, provided that the patient continues to meet the safety and efficacy parameters, the original implant will be removed and the patient can receive a new implant. At 13 months, patients who receive new implants will be evaluated at the study site and administratively transferred to the initial extension study. At Month 24), the implants inserted at Month 12 will be removed. At this time, patients who have completed the initial extension study and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, third) implant and to enter an additional 12-month extended access phase at the discretion of the investigator. At Month 36, the implants inserted at Month 24 for the Extended Access Phase will be removed. At this time, patients who have completed the Extended Access Phase and who wish to continue therapy with the histrelin implant will be eligible to receive a new (ie, fourth) implant and to enter the Long Term Extended Access Phase (referred to as the Implant Treatment Phase) at the discretion of the investigator. The purpose of this phase is to provide patients with the opportunity to continue to receive a new implant at the end of each 12-month period until the patient no longer requires hormone suppression. Once implant therapy is discontinued, all patients are eligible to enter the Long Term Follow Up Phase (Post Implant Phase) of the study.

Arms: arm 1: Subcutaneous implant designed to deliver histrelin continously for 12 months.
Interventions: intervention 1: Histrelin Subcutaneous Implant
Intervention descriptions: intervention 1: histrelin subcutaneous 50 mg implant

Protocol documents:
Clinical trial NCT00784979
Conditions: End Stage Renal Disease
Keywords: Renal Transplant PRA
Sponsor: Tampa General Hospital
Start date: 2002-01-01; Completion date: 2012-04-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to offer Panel Reactive Antibodies \[PRA\] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:

1. Immunological Testing
2. Transplant Nephrectomy
3. Pharmacologic Therapy
4. Plasmapheresis
5. Transplant

Detailed description:
Patients with high level of preformed antibodies (panel reactive antibodies \[PRA\]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.

Arms: arm 1: MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
Interventions: intervention 1: CMVIG
Intervention descriptions: intervention 1: 400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks

Protocol documents:
Clinical trial NCT00852969
Conditions: Chronic Kidney Disease
Keywords: Chronic Kidney Disease Niacin HDL Endothelial Function
Sponsor: Tufts Medical Center
Start date: 2008-08-01; Completion date: 2012-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to obtain information on whether raising levels of HDL-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. This may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Niacin intervention 2: Active Placebo
Intervention descriptions: intervention 1: 1000 mg tablets once per day intervention 2: 100 mg Niacin tablets once per day

Protocol documents:
Clinical trial NCT00860015
Conditions: Sarcoma, Soft Tissue
Sponsor: Columbia University
Start date: 2005-08-01; Completion date: 2012-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In patients with unresectable soft tissue sarcoma, what is the response rate if treated with Alimta and gemcitabine?

Detailed description:
Soft tissue sarcomas represent 0.7% of all malignancies diagnosed in the United States. The peak incidence occurs in children and young adults with a second peak occurring in middle age, resulting in significant morbidity and mortality in young, productive individuals. Although limb preserving surgery and radiation therapy have improved the primary treatment of these tumors, the therapy of advanced, metastatic tumors is unsatisfactory. The purpose of this phase II study is to evaluate the efficacy of treatment with Alimta and gemcitabine given on day 1 of a 14 day cycle to patients with unresectable or metastatic soft tissue sarcomas. Gemcitabine is an established salvage therapy for soft tissue sarcomas in combination with docetaxel. Alimta is a multitargeted antifolate drug which inhibits several folate dependent enzymes required for cell proliferation. Alimta has shown efficacy in several solid tumor types both as a single agent and in combination with other agents. The combination of Alimta and gemcitabine is synergistic and is likely to have efficacy against soft tissue sarcomas. The primary objective of this study is to determine the response rate among patients with unresectable soft tissue sarcoma treated with this combination. Secondary endpoints will evaluate the median survival of this patient population, as well as time to objective tumor response, time to treatment failure and overall survival. The toxicities of this regimen in this population will also be analyzed. Given the desperate need for new agents to treat these patients, a phase II trial of this combination therapy should be pursued.

Arms: arm 1: IV administration of drugs for 14 days for up to 4 cycles
Interventions: intervention 1: Alimta intervention 2: Gemcitabine
Intervention descriptions: intervention 1: 500 mg/m2 via IV over 10 minutes

A chemotherapy drug with indications to treat pleural mesothelioma and non-small cell lung cancer. intervention 2: 1000 mg/m2 via IV over 90 minutes

A nucleoside analog used as chemotherapy.

Protocol documents:
Clinical trial NCT00877071
Conditions: Hepatocellular Carcinoma
Sponsor: University of Pittsburgh
Start date: 2008-11-01; Completion date: 2012-04-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Advanced HCC represents a high unmet medical need with a poor prognosis and few therapeutic options. Patients who present with HCC beyond the currently accepted Milan criteria are not eligible to be listed for liver transplantation. The proposed study offers local regional therapy to a defined population of patients beyond Milan criteria as an attempt to downstage them to eligibility for liver transplant.

Detailed description:
LC BeadTM is a new product specifically designed for TACE. LC BeadTM microspheres can be loaded with doxorubicin (Trade name: adriamycin), a chemotherapeutic anthracycline glycolide agent widely accepted for treatment of HCC. This novel bead slowly releases the ionically bound chemotherapeutic agent rather than administering a bolus of chemotherapy as is the case with many alternative methods of TACE. Thus, the LC BeadTM offers the potential advantage of less toxicity and prolonged tumor exposure.

This study offers local regional therapy to a defined population of patients beyond transplant criteria as an attempt to downstage them to eligibility for liver transplantation. This study will make an important contribution to understanding the beads' local effect as seen in the explanted livers of those patients who go on to receive a liver transplant. Additionally, we will examine the impact of this novel treatment tool on patients' quality of life.

Arms: arm 1: Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility
Interventions: intervention 1: LC Bead loaded with doxorubicin
Intervention descriptions: intervention 1: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation

Protocol documents:
Clinical trial NCT00878722
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia PXD101 Belinostat Idarubicin
Sponsor: Valerio Therapeutics
Start date: 2007-08-01; Completion date: 2012-04-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, non-randomized, multi-centre, Phase I/II trial to assess the efficacy and safety of 2 schedules of PXD101 in combination with idarubicin in patients with AML not suitable for standard intensive therapy.

Detailed description:
This trial is an open-label, multi-centre, dose-escalation Phase I/II study to evaluate safety, explore efficacy, pharmacodynamics, and pharmacokinetics of the combination of PXD101 with idarubicin administered in two different schedules in patients with AML. The PXD101 plus idarubicin treatment will be repeated at suitable intervals (target is every 3 weeks for schedule A and every 2 weeks for schedule B) depending upon toxicities or disease progression. Safety and efficacy assessments will be performed at every cycle.

Schedule A uses PXD101 by 30 min infusion daily for 5 days every 3 weeks with escalating doses of idarubicin.

Schedule B uses escalating doses of continuous infusion (48h) of PXD101 alone or in combination with idarubicin.

In both regimens the trial may be expanded at the Maximum Tolerated Dose (MTD).

Arms: arm 1: PXD101 administered as a 30-minute intravenous (IV) infusion of 1000 mg/m²/d for five consecutive days every 3 weeks.

Idarubicin administered on day 5 (first steps) or days 4 and 5 (later steps). Patients will be treated in a 21-day cycle for a minimum of 2 cycles and a maximum of 6 cycles (depending on cumulated idarubicin dose). arm 2: PXD101 administered by continuous intravenous infusion over 24-48 hours and idarubicin (in the later steps) added after the first 24 hours. The second cycle will start on day 15 but under observation of possible toxicity. Further cycles will be administered q 14 d for up to 6 cycles. The first dose steps will be carried out with PXD101 alone for safety reasons.
Interventions: intervention 1: PXD101 intervention 2: idarubicin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00906503
Conditions: Pulmonary Nodule
Keywords: pulmonary nodule
Sponsor: Barbara Ann Karmanos Cancer Institute
Start date: 2009-04-01; Completion date: 2012-04-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before and after steroid therapy may help doctors assess a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I trial is studying fludeoxyglucose F 18 PET scan performed before and after ultra short-term dexamethasone therapy to see how well it measures changes in nodules in patients with lung nodules.

Detailed description:
OBJECTIVES:

* To determine whether ultra short-term steroid therapy (24-48 hours) can be used to increase the accuracy of fludeoxyglucose F 18 positron emission tomography/computed tomography (FDG-PET/CT) imaging in categorizing nodules in patients with pulmonary nodules.
* To calculate the overall sensitivity and specificity of the nodules group, based on FDG uptake, for predicting malignancy.
* To gather effect-size estimates that will be used to improve the quality of a larger follow-up study.

OUTLINE: Patients receive oral dexamethasone at 40, 28, 16, and 4 hours before imaging. Patients undergo fludeoxyglucose F 18 (FDG)-positron emission tomography/computed tomography (PET/CT) imaging at baseline and upon completion of steroid therapy.

After completion of study therapy, patients are followed for 6 months.

Arms: arm 1: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
Interventions: intervention 1: dexamethasone intervention 2: PET/Computed Tomography (CT) intervention 3: fludeoxyglucose (18F)
Intervention descriptions: intervention 1: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan intervention 2: Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs intervention 3: Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs

Protocol documents:
Clinical trial NCT00927186
Conditions: Osteoporosis, Post-menopausal
Keywords: osteoporosis teriparatide zoledronic acid histomorphometry bone biopsy postmenopausal
Sponsor: Eli Lilly and Company
Start date: 2009-07-01; Completion date: 2012-04-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate how teriparatide or zoledronic acid affects the bone of postmenopausal osteoporotic women after 6 months of treatment as determined by a bone biopsy sample taken from the iliac crest (upper part of the pelvis). After completing 12 months of treatment all participants are eligible to participate in an additional 12-month open label extension.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Teriparatide intervention 2: Zoledronic Acid
Intervention descriptions: intervention 1: 20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension. intervention 2: 5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.

After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.

Protocol documents:
Clinical trial NCT00927823
Conditions: Cancer
Sponsor: Pfizer
Start date: 2009-12-01; Completion date: 2012-04-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A phase 1 dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of PF-04691502 in adult cancer patients with solid tumors.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-04691502
Intervention descriptions: intervention 1: Once daily continuous dosing. Dose escalation to Maximally tolerated dose (MTD) until progression or discontinuation.

Protocol documents:
Clinical trial NCT00935064
Conditions: Diabetes
Keywords: Diabetes
Sponsor: Christiana Care Health Services
Start date: 2009-06-01; Completion date: 2012-04-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effect of direct renin inhibition on nerve function in persons with diabetes using a double-blind, placebo-controlled randomized trial involving two treatment arms (i.e., \[1\] 30 participants enrolled and randomized to 300 mg of Aliskiren; \[2\] 30 participants enrolled and randomized to placebo).

Detailed description:

Arms: arm 1: Pill, 300 mg, once daily, for 6 weeks arm 2: None
Interventions: intervention 1: Aliskiren intervention 2: Placebo
Intervention descriptions: intervention 1: Pill, 300 mg, once daily, for 6 weeks intervention 2: Placebo orally one tablet once a day for 6 weeks.

Protocol documents:
Clinical trial NCT00943072
Conditions: Macular Edema Secondary to Central Retinal Vein Occlusion
Keywords: Macular edema Retinal vein occlusion CRVO VEGF Trap-Eye best-corrected visual acuity Regeneron COPERNICUS
Sponsor: Regeneron Pharmaceuticals
Start date: 2009-07-01; Completion date: 2012-04-01
Enrollment: 189 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3 study to determine the efficacy of VEGF Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion.

Detailed description:

Arms: arm 1: Monthly IVT injection of VEGF Trap-Eye 2.0 mg until Week 24 Primary Endpoint arm 2: Monthly Sham IVT injection until Week 24 Primary Endpoint
Interventions: intervention 1: VEGF Trap-Eye 2.0mg intervention 2: Sham
Intervention descriptions: intervention 1: Monthly intravitreal injection out to the Week 24 Primary endpoint intervention 2: Monthly sham intravitreal injection out to Week 24 Primary Endpoint

Protocol documents:
Clinical trial NCT00950911
Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Keywords: Bone metastases Hormone-refractory prostate cancer Multiple myeloma Denosumab Breast cancer 20050103 20050136 20050244 Advanced cancer Tumor Prostate cancer Zoledronic acid
Sponsor: Amgen
Start date: 2009-07-01; Completion date: 2012-04-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: amg 162
Intervention descriptions: intervention 1: 120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.

Protocol documents:
Clinical trial NCT00952692
Conditions: Metastatic Breast Cancer
Keywords: breast cancer HER2 Lapatinib dHER2 ASCI overexpressing HER2 refractory to trastuzumab
Sponsor: Michael Morse, MD
Start date: 2009-07-01; Completion date: 2012-04-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/II study to determine the safety and gain insight into the immune response of the immunologic agent dHER2+AS15 ASCI when administered in combination with lapatinib. This study is for patients with metastatic breast cancer (invasive breast cancer with stage IV disease) that overexpresses HER2 and is resistant to trastuzumab (Herceptin).

The dHER2 + AS15 candidate Antigen-Specific Cancer Immunotherapeutic (ASCI) contains a recombinant protein termed dHER2, which is a truncated version of the HER2 protein. HER2 is a protein that is commonly overexpressed in breast cancer. This protein is combined with the immunological adjuvant AS15 Adjuvant System from GSK (GlaxoSmithKline), which is a liposomal formulation containing three immunostimulatory components.

Lapatinib is FDA approved for use in combination with capecitabine for the treatment of subjects with advanced or metastatic breast cancer whose tumors overexpress HER2.

Detailed description:

Interventions: intervention 1: dHER2 + AS15 ASCI intervention 2: Lapatinib
Intervention descriptions: intervention 1: Patients will receive dHER2 ASCI injections IM every 2 weeks for 2 cycles . In between cycles there is 4 weeks without vaccine.

For each dose of 500µg of dHER2 + AS15 ASCI, two sterile glass vials will be supplied:

* One vial with the lyophilized preparation containing 500 ug of recombinant dHER2 antigen combined with the immunostimulant.
* One vial with liquid adjuvant diluent. The final dHER2 + AS15 ASCI for administration is obtained by reconstitution of the lyophilized preparation with the adjuvant diluents. A dHER2 + AS15 ASCI dose consists of 0.5 ml. intervention 2: The daily dose of lapatinib is 5 tablets (1250 mg of lapatinib) taken orally at approximately the same time each day for 43 weeks while on study.

Protocol documents: