ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00428610
Conditions: Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-02-01; Completion date: 2012-01-01
Enrollment: 103 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to determine whether LY573636-sodium (hereafter referred to as LY573636) is effective in treating platinum-resistant ovarian cancer. Patients will receive an intravenous infusion of study drug once every 28 days. Computed tomography (CT) scans and CA-125 tests will be done before the first dose and then after every other treatment.

Detailed description:

Arms: arm 1: LY573636-sodium (LY573636) is administered every 28 days until disease progression or other criteria for participant discontinuation are met.
Interventions: intervention 1: LY573636-sodium
Intervention descriptions: intervention 1: LY573636 dose is dependent on participant's height, weight, and gender and is adjusted to target a specific maximum concentration (Cmax) based on participant laboratory parameters. LY573636 is administered every 28 days until disease progression or other criteria for participant discontinuation are met.

Protocol documents:
Clinical trial NCT00428948
Conditions: Polycystic Kidney Disease, Autosomal Dominant
Keywords: ADPKD Polycystic kidney ADPKD (Autosomal Dominant Polycystic Kidney Disease)
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2007-01-01; Completion date: 2012-01-01
Enrollment: 1445 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

Detailed description:
This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, severity, and progression of other important consequences of ADPKD.

During the 3-week titration phase, tolvaptan or placebo was titrated in weekly intervals from lowest to highest tolerated levels given in split-dose regimens of 45/15 mg, 60/30 mg and 90/30 mg orally upon awakening and approximately 9 hours later. As soon as a subject could not tolerate a given dose, the titration phase was over and the maintenance phase began at the dose level tolerated. The maintenance phase lasted to Month 36. Subjects were able to titrate down at any point during the study. Subjects were able to titrate up during the maintenance phase with Medical Monitor approval.

Arms: arm 1: Participants received the highest tolerated split-dose regimen (upon awakening and 9 hours later) of tolvaptan 45/15 mg, 60/30 mg, or 90/30 mg orally for 36 months. arm 2: Participants received placebo (upon awakening and 9 hours later) orally for 36 months.
Interventions: intervention 1: Tolvaptan intervention 2: Placebo
Intervention descriptions: intervention 1: Tolvaptan was supplied as tablets. intervention 2: Placebo was supplied as tablets.

Protocol documents:
Clinical trial NCT00429793
Conditions: Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2007-02-01; Completion date: 2012-01-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
OBJECTIVES: Primary I. Determine the 6-month progression-free survival (PFS) or objective tumor response in patients with refractory or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with temsirolimus.

II. Determine the toxicity of this drug in these patients.

Secondary I. Determine the duration of PFS and overall survival of these patients.

OUTLINE: This is a nonrandomized, multicenter study.

Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days 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 52 patients will be accrued for this study.

Arms: arm 1: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: temsirolimus
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00444964
Conditions: Prader-Willi Syndrome
Sponsor: Children's Mercy Hospital Kansas City
Start date: 2005-04-01; Completion date: 2012-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months.

Detailed description:
The main research question this protocol aims to answer is whether treatment with growth hormone will impact body composition, quality of life, and energy balance in PWS adults, and if there is a loss of effects after cessation of treatment for at least 12 months. Specific outcomes to be evaluated are as follows:

• Increased IGF-1 as a function of human growth hormone dosage compared with baseline.

1. Improvement of indicators or risk factors for co-morbid diseases \[diabetes (by measuring insulin and glucose levels), cardiovascular disease (by measuring lipids and fatty acids), and pulmonary function\] in participants.
2. Improvement in quality of life measures as indicated by ratings on established behavior checklists in participants.
3. Changes in body composition (decreased fat, increased lean body mass and bone density) as determined by DEXA in participants.
4. Increased energy expenditure as determined by whole-room calorimeter measures (8 hour energy expenditure, RMR, TEF, mechanical work); diet records, physical activity monitors and strength measures.

Arms: arm 1: Nutropin AQ
Interventions: intervention 1: Nutropin AQ
Intervention descriptions: intervention 1: 0.0125 mg/kg/day

Protocol documents:
Clinical trial NCT00448240
Conditions: Head and Neck Cancer Carcinoma, Squamous Cell
Sponsor: Henry Ford Health System
Start date: 2007-02-01; Completion date: 2012-01-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if combination Erlotinib, Cisplatin/Carboplatin, and Paclitaxel are effective first line treatment for metastatic, recurrent and persistent squamous cell carcinoma of the head and neck.

Detailed description:
We hypothesize that Erlotinib fails to enhance the effects of chemotherapy on response and survival because of Erlotinib's cytostatic effect, this results in a slowing down of the cell cycle, this in turn results in a hampering of the cytotoxic effect of chemotherapy leading to a lack of synergism with the combination. We propose that a sequential approach to the combination allows each drug to be used in its optimum time, by sequencing the Erlotinib, giving it 24 hours after chemotherapy we allow the chemotherapy to exert its effect with cells actively in cell cycle, but delivering the Erlotinib at a time when cells are trying to return to cell cycle hence slowing the growth rate of the tumor cell population. By withdrawing the Erlotinib about 4 days prior to the next chemotherapy cycle, we allow the cells to go back into cell cycle and therefore become susceptible to chemotherapy again.

Patients will be treated with intravenous paclitaxel over 3 hours followed by intravenous cisplatin/carboplatin on Day 1 of each 21 day cycle. Patients will be treated with Erlotinib at a loading dose of 300mg on Day 2 followed by 150 mg orally daily from Days 3-17 of each cycle of paclitaxel and cisplatin/carboplatin.

The primary objectives of this study are to assess the response rate of combination of erlotinib, cisplatin/carboplatin and paclitaxel in the first line treatment setting of metastatic, recurrent and persistent squamous cell carcinoma of the head and neck. Secondary objectives are to assess toxicity, median survival, and progression free survival.

Arms: arm 1: Erlotinib (Tarceva) During First Line Standard Platinum Containing Chemo
Interventions: intervention 1: Erlotinib
Intervention descriptions: intervention 1: loading dose of 300 mg on Day 2 followed by 150 mg daily Days 3 - 17 of each cycle of paclitaxel and cisplatin/carboplatin

Protocol documents:
Clinical trial NCT00461591
Conditions: Bladder Cancer
Keywords: Noninvasive Bladder Cancer
Sponsor: Spectrum Pharmaceuticals, Inc
Start date: 2007-04-01; Completion date: 2012-01-01
Enrollment: 802 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.

Detailed description:
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder.

A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3).

* If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).
* If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10).

All patients were to be followed for 2 years.

Arms: arm 1: TURBT + a single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT arm 2: TURBT + a single intravesical dose of placebo instilled into the bladder post-TURBT
Interventions: intervention 1: Apaziquone intervention 2: Placebo intervention 3: TURBT
Intervention descriptions: intervention 1: A single intravesical dose of Apaziquone 4mg in 40ml instilled into the bladder post-TURBT intervention 2: A single intravesical dose of placebo instilled into the bladder post-TURBT intervention 3: TransUrethral Resection of the Bladder Tumor

Protocol documents:
Clinical trial NCT00490698
Conditions: Kidney Cancer Renal Cell Carcinoma
Keywords: Kidney Cancer Renal Cell Carcinoma Bone-Targeted Therapy Zoledronate Zometa Atorvastatin Lipitor RCC
Sponsor: M.D. Anderson Cancer Center
Start date: 2006-10-01; Completion date: 2012-01-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objectives:

Primary:

Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy

Secondary:

1. Evaluate clinical outcome based on the presence of calcification at the site of osteolytic metastases
2. Measure bone-formation and resorption markers at baseline and during bone-targeted therapy.
3. Assess effect of the bone-targeted regimen on serum cholesterol levels

Detailed description:
Kidney cancer often spreads (metastases) to the bones. Zoledronate is designed to protect the bones from pain and from breaking as a result of cancer. Atorvastatin is a drug that lowers cholesterol levels in the blood. Combining these medications may make zoledronate more effective.

If you are found to be eligible to take part in this study, you will be given zoledronate intravenously (IV--through a needle in your vein) over fifteen minutes,1 time every 4 weeks. You will take a pill, atorvastatin, by mouth once time a day every day that you are on the study. Every 4 weeks is considered 1 study "cycle".

You will need to return to M. D. Anderson for check-ups every 8 -12 weeks. Urine will be collected for routine tests. You will have x-rays, bone scans, and/or CT scans to check on the status of the disease.

You will receive at least 2 cycles of treatment unless intolerable side effects occur or your disease gets worse. You may receive more than 2 cycles if you are benefitting from the study drugs.

You will be followed every 8 weeks for up to 1 year for skeletal events (symptoms related to disease moving to or getting worse in your bones). You will be taken off study if you experience a skeletal event or at the end of the 1-year monitoring period. Monitoring may be done with a local doctor or at M. D. Anderson. No extra testing or procedures are needed during this period.

This is an investigational study. The combination of the 2 drugs given in this study is investigational for the treatment of bone metastases. Zoledronate is approved for the treatment of bone metastases. Atorvastatin has been approved by the FDA for lowering cholesterol. About 38 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
Interventions: intervention 1: Zoledronate intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 4 mg IV Once Every 4 Weeks intervention 2: 20 mg PO Daily

Protocol documents:
Clinical trial NCT00496379
Conditions: Breast Cancer CNS Disease
Keywords: metastatic breast cancer invasive breast cancer brain metastases ZK-EPO
Sponsor: Nancy Lin, MD
Start date: 2007-07-01; Completion date: 2012-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.

Detailed description:
* Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.
* During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.
* At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.
* After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.
* At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.

Arms: arm 1: None
Interventions: intervention 1: ZK219477
Intervention descriptions: intervention 1: Given intravenously over approximately 30 minutes once every 3 weeks

Protocol documents:
Clinical trial NCT00541931
Conditions: Skin Diseases
Sponsor: Stanford University
Start date: 2007-10-01; Completion date: 2012-01-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We are seeking healthy female volunteers to determine if multinutrient supplementation affects visible signs of skin aging as well as blood measurements of aging. We are seeking smokers and non-smokers.

Detailed description:
Skin antioxidant levels as well as blood metabolites may change as the human body ages1,2. Although the chronological aging process is unstoppable, the physical signs of aging, particularly characteristics of the skin, may be delayed through a variety of medical interventions such as topical medications or resurfacing lasers. It is not currently known whether skin carotenoid antioxidant levels correlate with skin aging characteristics, although studies with other antioxidants suggest this may be true 3. In addition, while selected blood metabolites correlate with changes in age2, we do not know if this correlates with skin changes. Our current study focuses on whether differences in skin carotenoid levels and blood metabolite levels correlate with skin aging characteristics in age-matched subjects. Furthermore, we will explore whether three months consumption with a commercial multi-nutrient formulation (LifePak Nano) affects metabolic markers of aging, skin aging characteristics including skin elasticity and transepidermal water loss. We will also examine whether smokers respond differently from nonsmokers in the above parameters after supplementation.

Arms: arm 1: Nonsmokers Intervention: Dietary Supplement: LifePak Nano arm 2: Smoker arm Intervention: Dietary Supplement: LifePak Nano
Interventions: intervention 1: Dietary Supplement: LifePak Nano
Intervention descriptions: intervention 1: Daily use

Protocol documents:
Clinical trial NCT00550173
Conditions: Non-Small-Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-11-01; Completion date: 2012-01-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the combination of erlotinib and pemetrexed versus either pemetrexed alone and erlotinib alone, in terms of progression-free survival (time until the objective worsening of the disease) in patients who have never smoked and have locally advanced or metastatic Nonsquamous Non-Small Cell Lung Cancer who have failed a first-line chemotherapy treatment.

Detailed description:

Arms: arm 1: Pemetrexed 500 milligrams per meter squared (mg/m\^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months. arm 2: Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months. arm 3: Pemetrexed 500 mg/m\^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
Interventions: intervention 1: pemetrexed intervention 2: erlotinib
Intervention descriptions: intervention 1: 500 milligrams per meter squared (mg/m\^2), intravenous (IV), every (q) 21 days until progression or unacceptable toxicity develops intervention 2: 150 mg, orally, once daily until progression or unacceptable toxicity develops

Protocol documents:
Clinical trial NCT00569673
Conditions: Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer
Keywords: recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer
Sponsor: Gynecologic Oncology Group
Start date: 2008-03-01; Completion date: 2012-01-01
Enrollment: 71 participants; Allocation: ; Intervention model: 

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Detailed description:
OBJECTIVES:

Primary

* To estimate the antitumor activity of docetaxel plus trabectedin in patients with persistent or recurrent ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer primarily through the frequency of objective tumor responses.
* To determine the nature and degree of toxicity of docetaxel plus trabectedin in this cohort of patients.

Secondary

* To estimate the progression-free survival and overall survival of patients treated with docetaxel and trabectedin.

OUTLINE: Patients receive docetaxel IV over 1 hour and trabectedin IV over 3 hours on day 1. Patients also receive pegfilgrastim subcutaneously (SC) on day 1 OR filgrastim (G-CSF) IV over 15-30 minutes or SC once daily beginning on day 1 and continuing until blood counts recover. Treatment repeats every 3 weeks 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.

Interventions: intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: docetaxel intervention 4: trabectedin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: