ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00647426
Conditions: Non-Small Cell Lung Cancer
Keywords: Stage IIIB/IV
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2007-11-01; Completion date: 2012-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single institution, phase II study of Sorafenib in combination with docetaxel and carboplatin in patients with advanced non-small cell lung cancer. Docetaxel and carboplatin will be given on day 1 of every three week cycle. Patients will take Sorafenib twice a day on the 1st day of treatment and continue to take the medication every day until progression of disease, prohibitive toxicity, or patient withdrawal from the study. Chemotherapy courses will repeat every 21 days in the absence of disease progression or unacceptable toxicity for a total of four cycles.

Detailed description:
Patients will be monitored after every two cycles (6 weeks) for tumor response, stability, or progression by radiographic imaging studies. The primary goal of this study is to determine the clinical response rate of this regimen in patients with advanced lung cancer. Secondary endpoints include time to progression, overall survival, and toxicity. Blood levels of ERK-phosphorylation, activated caspase 3, cyclin D1, anti -cIAP2, p-Akt, and Mcl1 activity will be measured at the beginning, middle and end of therapy to help identify predictors of drug response and toxicity during the first cycle of treatment.

Arms: arm 1: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle
Interventions: intervention 1: Sorafenib + Docetaxel/Carboplatin
Intervention descriptions: intervention 1: 400 mg po BID Sorafenib + 75 mg/m2 IV Docetaxel on day 1 plus AUC 6 on Carboplatin on day 1 of each 21 day cycle

Protocol documents:
Clinical trial NCT00659529
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis inflammation pH EBC sputum biomarkers phosphodiesterase inhibitors
Sponsor: National Jewish Health
Start date: 2008-08-01; Completion date: 2012-12-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether sildenafil can decrease inflammation in CF lung disease.

Detailed description:
This study is an open-label study that examines the use of sildenafil (Revatio) in clinically stable patients with mild to moderate CF lung disease. The length of participation for each subject will be approximately 10 weeks, and will consist of a screening visit, a study visit for initiation of study drug if subject qualifies, interim visits to escalate drug dose, obtain drug levels, review concomitant medications and assess side effects, a visit at the end of the therapy period (to reassess inflammatory markers, laboratory studies and side effects,) and a follow-up assessment 2 weeks after subject completion.

Arms: arm 1: All subjects will receive oral sildenafil three times per day during the study. Study endpoints will be measured before the treatment period and at the end of the treatment period.
Interventions: intervention 1: sildenafil
Intervention descriptions: intervention 1: Sildenafil will be given 20mg po tid for 1 week, and then will be give 40mg po tid for 5 weeks.

Protocol documents:
Clinical trial NCT00670982
Conditions: Breast Cancer
Keywords: HER2 positive bevacizumab vinorelbine trastuzumab
Sponsor: Harold J. Burstein, MD, PhD
Start date: 2008-05-01; Completion date: 2012-12-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the effects of the combination of bevacizumab, vinorelbine, and trastuzumab on participants and their cancer.

Detailed description:
* Participants will receive bevacizumab intravenously every 2 weeks. They will also receive trastuzumab and vinorelbine intravenously once a week. Therefore, treatments will alternate between receiving all three drugs (1st week, third week, fifth week, etc.) and receiving only trastuzumab and vinorelbine (2nd week, fourth week, sixth week, etc.) A treatment cycle lasts four weeks.
* During all treatment cycles a physical exam will be performed and the participant will be asked general health and specific questions about any problems they are experiencing.
* X-ray, CT scans, and/or MRI scans will be performed every 8 weeks (every 2 cycles) in order to assess the effect of the study treatment on the participants cancer. These tests are considered standard of care in patients receiving chemotherapy.
* Once a week blood counts will be performed and at least every 4 weeks, chemistry and other tests to measure any additional effect of the study drug and disease status will be checked. These tests are also considered standard of care for patients receiving chemotherapy.
* At the beginning of the study and at the 4- and 8-week time point, additional blood will be drawn in order to conduct research blood tests to measure the presence of cancer cells in the blood.
* A urine test and MUGA scan or echocardiogram will be done every 8 weeks while the participant in on the study.
* Participants can remain on the research study as long as the study treatment appears to be working and they are not experiencing unacceptable side effects.

Arms: arm 1: Patients with no prior therapy for metastatic breast cancer will receive bevacizumab intravenously every 2 weeks and vinorelbine intravenously once per week, and trastuzumab intravenously once per week arm 2: Patients with 1 prior line for metastatic breast cancer will receive bevacizumab intravenously every two weeks, vinorelbine intravenously once per week, and trastuzumab intravenously once per week.
Interventions: intervention 1: bevacizumab intervention 2: vinorelbine intervention 3: trastuzumab
Intervention descriptions: intervention 1: Given intravenously every 2 weeks intervention 2: Given intravenously once a week intervention 3: Given intravenously once a week

Protocol documents:
Clinical trial NCT00673127
Conditions: Prostate Cancer
Keywords: hormone refractory KHAD ketoconazole dutasteride hydrocortisone
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2005-02-01; Completion date: 2012-12-01
Enrollment: 57 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The combination of ketaconazole and hydrocortisone is commonly used for the treatment of prostate cancer. The purpose of this study is to determine if the addition of a drug called dutasteride to this approved combination will make the combination more effective in treating prostate cancer.

Detailed description:
* Participants will be seen by the study physician every four weeks and have a short physical examination, blood tests and be asked to provide information about their condition. Every three months they will undergo a bone scan. If the CT scan that was obtained before the participant started the study shows evidence of cancer, they will be asked to repeat this test every three months.
* Ketaconazole will be taken orally three times a day on an empty stomach. Hydrocortisone will be taken orally in the morning and at night. Dutasteride will be taken orally once a day.
* Participants may remain on study drug until there is evidence of disease progression.

Arms: arm 1: Ketoconazole, Hydrocortisone and Dutasteride Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Dutasteride: 0.5 mg once a day
Interventions: intervention 1: Ketoconazole, Hydrocortisone and Dutasteride
Intervention descriptions: intervention 1: Ketoconazole: 200mg orally three times a day on an empty stomach. Hydrocortisone: 30mg in the morning and 10mg in the evening. Pills should be taken with food or milk.

Dutasteride: 0.5mg orally once a day on an empty stomach or after eating a meal

Protocol documents:
Clinical trial NCT00685815
Conditions: Restless Legs
Keywords: IV Iron Restless Legs Syndrome RLS Iron
Sponsor: American Regent, Inc.
Start date: 2006-11-01; Completion date: 2012-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Double-blind, placebo-controlled, entitled: "Intravenous Iron Metabolism in Restless Legs Syndrome

Detailed description:
To determine the effects of high-dose infusions of iron on Restless Legs Syndrome (RLS) symptoms and brain concentrations of iron.

Arms: arm 1: Intravenous iron (FCM) arm 2: normal saline
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Placebo
Intervention descriptions: intervention 1: 500mg FCM in 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4 intervention 2: 250cc normal saline (NS) IV over one hour, once on Day 3, once on Day 4

Protocol documents:
Clinical trial NCT00691054
Conditions: Pancreatic Cancer
Keywords: recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer
Sponsor: University of Miami
Start date: 2008-06-01; Completion date: 2012-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with locally advanced or metastatic pancreatic cancer that did not respond to first-line therapy with gemcitabine.

Detailed description:
OBJECTIVES:

Primary

* To establish preliminary evidence of efficacy of paclitaxel albumin-stabilized nanoparticle formulation in patients with locally advanced (unresectable) or metastatic pancreatic cancer that failed first-line therapy with a gemcitabine hydrochloride-containing regimen.

Secondary

* To determine the safety and characterize the toxicity profile of this drug.
* To determine the complete, partial, and overall response rates and duration of response in patients with measurable disease.
* To determine CA 19-9 response.
* To determine progression-free survival.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. 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 1 year and then annually thereafter.

Arms: arm 1: One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4.
Interventions: intervention 1: Abraxane
Intervention descriptions: intervention 1: One treatment-cycle is 28 days with chemotherapy (Abraxane® 100 mg/m2) given on day 1, 8, and 15, followed by rest on week 4. Treatment cycles will be repeated every 28 days for as long as disease is not progressing and patient tolerates treatment

Protocol documents:
Clinical trial NCT00698035
Conditions: Sexual Dysfunction, Physiological
Keywords: Vaginal Testosterone Cream ESTRING
Sponsor: University of California, San Francisco
Start date: 2007-03-01; Completion date: 2012-12-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.

Detailed description:
There is a growing body of scientific literature to suggest that sexual functioning is one of the most distressing problems experienced by breast cancer survivors. Vaginal dryness, dyspareunia (pain during sexual intercourse), and decreased libido are common complaints among breast cancer patients. With increasing use of aromatase inhibitors which are associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming even more prominent. This study will evaluate the safety and tolerability of the ESTRING and 1% testosterone cream administered vaginally as treatments for vaginal dryness and/or decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.

Arms: arm 1: Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment arm 2: Estring 2mg ring inserted vaginally once every 12 weeks
Interventions: intervention 1: Testosterone Cream intervention 2: Estring
Intervention descriptions: intervention 1: 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment intervention 2: 2mg ring inserted vaginally once every 12 weeks

Protocol documents:
Clinical trial NCT00704288
Conditions: Glioblastoma Multiforme
Keywords: GBM Malignant gliomas
Sponsor: Exelixis
Start date: 2008-05-01; Completion date: 2012-12-01
Enrollment: 222 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the objective response rate and 6-month progression-free survival rate of XL184 in subjects with recurrent or progressive glioblastoma multiforme. XL184 is a new chemical entity that inhibits VEGFR2, MET and RET, kinases implicated in tumor formation, growth and migration.

Detailed description:

Arms: arm 1: cabozantinib, 175 mg, taken orally once per day (qd). arm 2: cabozantinib, 125 mg, taken orally once per day (qd). arm 3: cabozantinib, 125 mg, taken orally once per day (qd).
Interventions: intervention 1: XL184
Intervention descriptions: intervention 1: Gelatin capsules supplied in 25-mg and 100-mg strengths; continuous daily dosing

Protocol documents:
Clinical trial NCT00706641
Conditions: Transitional Cell Carcinoma of the Bladder
Sponsor: Hoosier Cancer Research Network
Start date: 2008-06-01; Completion date: 2012-12-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot study is designed to determine feasibility and safety of treatment with dasatinib administered orally once daily for 4 weeks duration prior to radical cystectomy for urothelial carcinoma of the bladder.

Detailed description:
OUTLINE: This is a multi-center study.

This is a pilot study designed to determine the safety and feasibility of treatment with dasatinib 100 mg administered orally once daily for 4 weeks duration prior to radical cystectomy for patients with muscle-invasive transitional cell carcinoma of the bladder ineligible for and/or willing to forgo neoadjuvant cisplatin-based combination chemotherapy. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.

ECOG Performance Status 0-1

Life Expectancy: Not specified

Hematopoietic:

* Absolute Neutrophil Count (ANC) \> 1.5 K/mm3
* Platelets \> 100 K/mm3
* INR \< 1.2

Hepatic:

* Total bilirubin \< 2.0 X Upper Limit of Normal (ULN)
* Aspartate aminotransferase (AST) ≤ 2.5 X ULN.
* Alanine aminotransferase (ALT ) ≤ 2.5 X ULN

Renal:

* Serum creatinine \< 2 X ULN

Cardiovascular:

* No uncontrolled angina, congestive heart failure or MI within 6 months prior to registration on study.
* No diagnosed congenital long QT syndrome (a congenital disorder characterized by a prolongation of the QT interval on ECG and a propensity to ventricular tachyarrhythmias, which may lead to syncope, cardiac arrest, or sudden death).
* No history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de Pointes).
* No prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec), obtained within 28 days prior to being registered on study.

Arms: arm 1: Dasatinib 100 mg PO qd x 4 weeks followed by radical cystectomy 8-24 hours post last administered dasatinib dose
Interventions: intervention 1: Dasatinib intervention 2: Radical Cystectomy
Intervention descriptions: intervention 1: Dasatinib 100 mg administered orally once daily for 4 weeks duration (+/- 1 week) intervention 2: Radical cystectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered Dasatinib dose. All attempts should be made for the patient to have their surgery after 8 hours but within 24 hours of their last dose of dasatinib. If surgery delay is imperative, dasatinib therapy should continue until at least 24 hours before planned surgery.

Protocol documents:
Clinical trial NCT00707863
Conditions: Major Depression
Keywords: Escitalopram Lexapro fMRI pictures
Sponsor: Indiana University School of Medicine
Start date: 2008-05-01; Completion date: 2012-12-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out what parts of the brain have increased or decreased activity when people are depressed and how antidepressant medicine changes this activity in depressed patients. The genetic samples collected are to look at variation in a gene (serotonin transporter gene), which affects the functioning of the chemical serotonin in the brain

Detailed description:
This study will measure the activity in different parts of the brain, while the patients are seeing some pictures, using Magnetic Resonance Imaging (MRI) scan. For this study three MRI scans will be conducted. One before the patient begins on any medication, one during the study after 3 weeks of treatment and one after six more weeks of treatment with a standard antidepressant called Escitalopram(trade name: Lexapro).

Arms: arm 1: Subjects receiving Escitalopram (trade name: Lexapro) that are in the age range of 18-25 arm 2: Subjects receiving Escitalopram (trade name: Lexapro) in the age range of 26-50
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: 10 mg of Escitalopram by mouth once a day for 8 weeks

Protocol documents:
Clinical trial NCT00710970
Conditions: Urinary Bladder Neoplasms
Keywords: Urinary Bladder Neoplasms Previous Chemotherapy Tamoxifen Anti-tumor activity
Sponsor: Seth Lerner
Start date: 2007-01-01; Completion date: 2012-12-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The major objective of this two-stage phase II study is to determine whether tamoxifen is deserving of further study in metastatic bladder cancer. Tamoxifen is expected to function as a cytostatic (and not cytotoxic) agent, and may produce more disease stability than regression. Sustained stable disease is considered to be clinically important and the more likely event. Hence, 4-month freedom from progression is chosen as the primary end-point instead of response rate. Freedom from progression is defined as the period from start of therapy to the time of objective radiologic progression. A total of 25 subjects will be enrolled, 15 during stage 1 and 10 during stage 2 of a two-stage minimax design phase II study.

Pre-therapy evaluation (within 3 weeks of initiation of therapy):

* History and physical examination (H and P)
* Performance status (PS) assessment
* CBC (complete blood counts)
* CMP (complete metabolic profile)
* Pregnancy test (in women younger than 50)
* Computed tomography (CT) scan of the chest, abdomen and pelvis
* Bone scan if bone pain or raised alkaline phosphatase
* Biopsy (may use previous biopsy specimen)
* Samples of plasma from the routine CBC and CMP will be banked indefinitely for future biomarker studies at the Scott Department of Urology.

Treatment plan: Therapy will be administered as an outpatient. Tamoxifen is administered at 20 mg/day as a single daily oral dose. Clinical assessment of patients by a history and physical examination will be performed every 4 weeks (one cycle). Objective radiological assessment of response will be made every 8 weeks or earlier if clinically indicated. A CT (computerized tomography) scan of the abdomen, pelvis and chest will be performed at baseline and every 2 cycles. A response is confirmed by repeating the scans in 4 weeks. Bone scan is performed if the patient complains of new bone pain or has raised alkaline phosphatase. A radiologist who is blinded to the treatment regimen reads the scans. The RECIST criteria are used to define response. Tamoxifen is continued until progressive disease or intolerable side effects occur.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tamoxifen
Intervention descriptions: intervention 1: Tamoxifen is administered at 20 mg/day as a single daily oral dose. Tamoxifen is continued until progressive disease or intolerable grade 3 or 4 side effects occur due to tamoxifen.

Protocol documents:
Clinical trial NCT00720343
Conditions: Postoperative Pain Inflammation
Sponsor: Columbia University
Start date: 2009-02-01; Completion date: 2012-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research will test whether consuming additional choline before gynecological surgery decreases postoperative pain.

Detailed description:
More than 70% of the patients undergoing surgery in the USA, experience moderate to severe pain after the surgery in spite of being treated for pain. We will test whether choline will produce an effective additional analgesic action for postoperative pain treatment. Choline and lecithin are safe and are available for consumers as over-the-counter nutritional supplements. Choline supplementation decreases postoperative pain in rodents. Also Nicotine decreases postoperative pain in humans and since choline acts on the same receptors as nicotine, choline supplementation may be effective as an analgesic without the risks of addiction and the side effects like high heart rate and blood pressure.

Sixty women between the ages 18 and 60 undergoing open abdominal gynecological surgeries will be studied. We will not study people with chronic pain, drug abuse, and/or nicotine use over the past six months, current pregnancy or breastfeeding, allergy to soy, or inability to take any drug that we will use in the study.

Patients will take 10 tablets (choline or gelatin powder placebo) the night before surgery. After anesthesia, a second dose will be given into a tube that goes into the patient's stomach. One tablespoon of blood (15 mL) will be drawn five times to measure genetics, changes in levels of plasma choline and inflammatory markers: blood will be drawn at the preoperative visit, three times on the day of surgery and once 24 hours postoperatively. At 24 hours after surgery and on their follow-up visit with their doctor, the patient's surgical wound will be photographed and patients will complete a survey on satisfaction with treatment.

Primarily we are looking at the pain scores after surgery and secondarily at the pain medication use, plasma choline levels, wound healing and satisfaction with pain treatment.

This is a randomized double blind study. Patients will consume ten tablets (10g choline or placebo) the night before undergoing gynecological surgery and 10 tablets the morning of surgery. We will measure pain after surgery, baseline and postoperative plasma choline, and test genetics.

Arms: arm 1: Oral choline arm 2: Gelatin Capsule
Interventions: intervention 1: Choline intervention 2: Placebo
Intervention descriptions: intervention 1: Oral Choline 20 grams before surgery intervention 2: Gelatin Capsule

Protocol documents: