ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00580983
Conditions: Head and Neck Cancer
Keywords: Head and Neck cancer
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2003-08-01; Completion date: 2010-06-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.

Detailed description:
Studies show that a dose response relationship in the salivary glands exists and that it may be possible to improve significantly post-radiation xerostomia and quality of life if radiation techniques can be devised that would spare the salivary glands while adequately treating the targets. A new treatment modality (computer-optimized IMRT) facilitates increased sparing of noninvolved tissue, specifically the sparing of both parotid glands, and more conformal high-dose delivery to the bilateral neck targets in patients with head and neck cancer. This study will evaluate the benefits regarding xerostomia-specific and general QOL in patients receiving head and neck RT using this modality. Assessment of swallowing dysfunction and aspiration will be made using videofluoroscopy. In addition, this study will evaluate the pattern of local/regional tumor recurrence, to assess whether sparing both parotid glands may cause tumor recurrence in spared neck areas.

Arms: arm 1: Chemotherapy:

Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.

Intensity-modulated Radiation Therapy (IMRT):

Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.

Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions.
Interventions: intervention 1: IMRT intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: Cisplatin intervention 5: 5-Fluorouracil
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00593957
Conditions: Rett Syndrome
Keywords: Rett Syndrome Dextromethorphan
Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Start date: 2004-08-01; Completion date: 2010-06-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Increased brain glutamate and its N-methyl-D-aspartate (NMDA) receptors found in the brain of younger Rett syndrome (RTT) patients cause toxic damage to neurons (the brain's nerve cells), and contributing to EEG spikes. Dextromethorphan (DM) acts by blocking NMDA/glutamate receptors. This study is being done to determine if DM will prevent the harmful over-stimulation of the neurons thereby reducing EEG spike activity. Treatment with DM consists of one of 3 different doses (0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day), and aims to find out which dose if any will help improve EEG abnormalities, behavior, cognition, and reduce seizures, as well as improve breathing abnormalities, motor capabilities, bone density, and GI dysfunction.

The study will include 90 females and males with RTT, 2 years-14.99 years of age, with a mutation in the methyl CpG binding protein 2 (MECP2) gene, and spikes on EEG, with or without clinical seizures.

Detailed description:
Patients meeting eligibility criteria(mutation +ve and having EEG spikes), will be admitted to the Pediatric Clinical Research Unit at Johns Hopkins Hospital and will have pharmacokinetics of DM determined to establish that they are rapid metabolizers of the drug. The baseline studies on initial admission include neurological, neuropsychology,EEG, gastroenterology, Occupational and Physical therapy evaluations. If the subject is a rapid metabolizer they will be randomized to one of the three drug doses. They are contacted by telephone, weekly in the first month, and monthly thereafter. They will be examined by a neurologist at 2 weeks,1 month, and 3 months during the drug trial. At each of these visits they will also be monitored for changes in complete blood count (CBC), electrolytes, and EKG. At the end of the 6 month drug trial the patients will be readmitted to Johns Hopkins Hospital when all baseline studies are repeated. Cost of travel, hospitalization and interim tests are free to participants.

Arms: arm 1: Dextromethorphan 0.25 mg/kg per day arm 2: Dextromethorphan 2.5 mg/kg/day arm 3: Dextromethorphan 5mg/kg/day
Interventions: intervention 1: Dextromethorphan intervention 2: Dextromethorphan
Intervention descriptions: intervention 1: Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial. intervention 2: Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.

Protocol documents:
Clinical trial NCT00597506
Conditions: Colorectal Adenocarcinoma
Keywords: colorectal refractory adenocarcinoma bevacizumab everolimus
Sponsor: Herbert Hurwitz
Start date: 2007-10-01; Completion date: 2010-06-01
Enrollment: 50 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find the safest and most effective dose of the drugs bevacizumab and everolimus given in combination for the treatment of metastatic colorectal cancer. Bevacizumab (also called Avastin™) is a drug that is given intravenously (through a vein). Everolimus (also called RAD001) is a tablet that is taken by mouth.

Bevacizumab is a protein that is thought to prevent the formation of blood vessels tumors need to grow. RAD001 has multiple capabilities, like bevacizumab it may prevent the formation of blood vessels needed by tumors and it also may stop tumor growth.

This study will try to find the safest dose of these drugs that can be tolerated when taken in combination. The study will look at how the drugs work in the body, and will see if there is any effect on metastatic colorectal cancer.

Detailed description:
This open-label, non-randomized expanded cohort trial of bevacizumab and RAD001 for patients with refractory metastatic colorectal cancer is designed to assess preliminary efficacy as well as the safety and tolerability of this combination. Patients will be accrued to this study at Duke University Medical Center and The Duke Oncology Outreach Network (DON)

After satisfying eligibility and screening criteria, patients will be treated on 28 day cycles.

* The treatment regimen is as follows:

  10 mg/kg Bevacizumab intravenous on days 1 and 15 and 10mg everolimus (RAD001) daily by mouth
* Toxicity will be assessed every visit, and as clinically indicated.
* Efficacy will be assessed every 2 cycles, and as clinically indicated.
* Patients may remain on treatment as long as they are deemed to be clinically benefiting from treatment, do not have progressive disease on restaging imaging (Section 6.0), or do not have any other reason for discontinuation of treatment as outlined in Section 3.4.
* Patients will undergo correlative studies as outlined in the study protocol

Arms: arm 1: 10 mg Everolimus(RAD001) daily by mouth, days 1-28 10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle
Interventions: intervention 1: Bevacizumab intervention 2: Everolimus
Intervention descriptions: intervention 1: 10 mg/kg intravenous bevacizumab given days 1 and 15 of each cycle intervention 2: 10 mg Everolimus(RAD001) daily by mouth, days 1-28

Protocol documents:
Clinical trial NCT00601523
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 511 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The general aim of this study is to obtain long-term safety and tolerability data on pramipexole ER, in daily doses from 0.375mg to 4.5mg once daily (q.d), in patients who have previously completed a pramipexole double-blind study in early PD (248.524(NCT00479401) or 248.636(NCT00558025) trial).

Detailed description:

Arms: arm 1: Patient to receive Pramipexole ER 0.375-4.5 mg tabl form daily arm 2: Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase.
Interventions: intervention 1: Placebo intervention 2: Pramipexole
Intervention descriptions: intervention 1: Patient to receive placebo tablets identical to Pramipexole ER tablets. Only during transfer phase. intervention 2: ER 0.375-4,5 mg

Protocol documents:
Clinical trial NCT00609518
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2008-02-01; Completion date: 2010-06-01
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chemotherapy for patients with non-squamous non-small cell lung cancer. Patients are given folic acid, vitamin B12 and steroids, both before and during treatment, to reduce the side effects associated with pemetrexed. The aim is whether it is possible to simplify the folic acid and steroid schedule without increasing toxicity.

Detailed description:

Arms: arm 1: Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment. arm 2: Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
Interventions: intervention 1: pemetrexed intervention 2: Folic acid intervention 3: Folic Acid intervention 4: Vitamin B12 intervention 5: dexamethasone intervention 6: dexamethasone
Intervention descriptions: intervention 1: 500 mg/m\^2 intravenous infusion on day 1 of each 21-day cycle. Number of Cycles: Until progression or to a maximum of 6 cycles. intervention 2: 350-1000 micrograms taken orally for at least 5 daily doses during the 7-day period prior to the first dose of pemetrexed then continues daily throughout treatment until 3 weeks after the last dose of pemetrexed. intervention 3: 350-1000 micrograms taken orally for two consecutive daily doses of folic acid the day before and the day of the first dose of pemetrexed the continues throughout treatment and for 3 weeks after the last dose of pemetrexed. intervention 4: 1000 micrograms intramuscular injection of vitamin B12 during the week prior to the first dose of pemetrexed then further injections given approximately every 9 weeks until 3 weeks after the last dose of pemetrexed. intervention 5: 4 mg taken orally \[or equivalent\] twice per day the day before, the day of, and the day after the first day of pemetrexed. Continue to give dexamethasone twice per day the day before, the day of, and the day after each dose of pemetrexed. intervention 6: 4 mg taken orally \[or equivalent\] twice per day on the day of the first dose of pemetrexed. Continue to give dexamethasone twice per day on the day of each dose of pemetrexed.

Protocol documents:
Clinical trial NCT00612807
Conditions: Major Depressive Disorder Partner Relational Disorder (V61.10)
Keywords: Older Adults
Sponsor: Duke University
Start date: 2006-07-01; Completion date: 2010-06-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary goal of this study is to develop and test a depression-specific marital therapy tailored for use with older adult populations.

Detailed description:
Major depression has been associated with many individual and interpersonal problems in later life, including inadequate social support, marital distress, spousal depression, poor physical health, and higher rates of mortality. Marital therapy has shown promise as a treatment for depression and coexisting marital distress in younger cohorts, and there is a robust association between social support and depressive symptoms in older adults. The combination of couple therapy and antidepressant medication may provide an ideal treatment for older adults by targeting interpersonal and biochemical aspects of depression.

Couples interested in this study will complete an initial assessment with study personnel. In Phase I, eligible couples will receive weekly marital therapy and the depressed partner will receive medication management with a study doctor for 6 months. In Phase II, couples will be randomly assigned to either the combination treatment (marital therapy plus medication management) or medication management alone for 6 months. At the end of the treatment phase, a thorough assessment will be completed. A follow-up assessment will be completed 6 months after completion of treatment.

Arms: arm 1: Medication management with a study doctor every other week. arm 2: Medication management with a study doctor every other week plus weekly marital therapy.
Interventions: intervention 1: Weekly marital therapy intervention 2: As indicated: Sertraline, bupropion, venlafaxine, mirtazepine, nortriptyline, tranylcypromine, lithium augmentation, etc.
Intervention descriptions: intervention 1: Weekly marital therapy for 6 months. intervention 2: Study doctor may prescribe antidepressant medication for the treatment of depression. Medications will be prescribed according to empirically supported guidelines outlined in the Duke Somatic Treatment Algorithm for Geriatric Depression (STAGED Approach; Steffens, 2002).

SSRIs (daily dose of at least 20 mg for citalopram, 20 mg for fluoxetine, 100 mg for sertraline, 20 mg for paroxetine)

SNRIs (e.g., venlafaxine)

Bupropion SR (achieve dose of at least 150 mg BID)

Mirtazapine

Tricyclic antidepressants (nortriptyline with drug levels 80-120 ng/dl)

Lithium augmentation

MAOI (daily dose of at least 30 mg tranylcypromine or 45 mg of phenelzine)

Protocol documents:
Clinical trial NCT00615901
Conditions: Breast Cancer
Keywords: cyclophosphamide methotrexate fluorouracil PEG-filgrastim
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-01-01; Completion date: 2010-06-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
CMF (cyclophosphamide, methotrexate, fluorouracil) is used to treat early stage breast cancer. The combination, of these three drugs, has been used for approximately 30 years in the treatment of breast cancer, and has been shown to be safe and effective. It is usually given every 3 weeks. Doctors believe, based on other breast cancer trials, that giving this type of chemotherapy in a shorter amount of time, every 2 weeks or sooner, instead of every 3 weeks, may be better. The purpose of this study is to test the safety of these drugs, given every 2 weeks or sooner, to treat breast cancer. Other breast cancer chemotherapy regimens have shown to be more beneficial when the drugs are given more frequently.

Detailed description:

Arms: arm 1: This is a pilot study using 8 cycles of CMF (cyclophosphamide 600 mg/m2, methotrexate 40 mg/m2, and fluorouracil 600 mg/m2), at 14 day intervals supported by PEG-filgrastim for a cohort of 38 patients. A safety analysis will then be performed.
Interventions: intervention 1: cyclophosphamide, methotrexate, fluorouracil, PEG-filgrastim
Intervention descriptions: intervention 1: C (cyclophosphamide) 600 mg/m2 M (methotrexate) 40 mg/m2 F (fluorouracil) 600 mg/m2 P (PEG-filgrastim ) 6 mg. Eight doses of CMF q 14 days with PEG-filgrastim administered approximately 24 hours after chemotherapy. Day 14, is also considered day 1 of the next cycle.

Protocol documents:
Clinical trial NCT00620373
Conditions: Breast Cancer
Keywords: Dense breast tissue Breast Cancer Screening Molecular Breast Imaging Breast Cancer Breast
Sponsor: Mayo Clinic
Start date: 2005-08-01; Completion date: 2010-06-01
Enrollment: 969 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.

Detailed description:
The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (\~90%) for the detection of breast cancers independent of breast density.

The aim of this study is to demonstrate the utility of MBI as an adjunct screening modality for the detection of occult breast cancers in women with mammographically dense breast tissue. Initial recruitment will be from the pool of patients awaiting a screening mammogram in the Department of Radiology at Mayo Clinic Rochester. All patients will have a screening MMO and an MBI study. Patients with positive studies (MBI or MMO) will undergo additional diagnostic studies. At 15 months post-recruitment, all patients will be contacted by phone or mail to determine whether subsequent to their study, there has been any change in their breast status.

Arms: arm 1: Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.
Interventions: intervention 1: Molecular Breast Imaging intervention 2: Conventional Mammography intervention 3: Technetium (99mTc) sestamibi
Intervention descriptions: intervention 1: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors. intervention 2: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool. intervention 3: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.

Protocol documents:
Clinical trial NCT00632970
Conditions: HIV Infections
Keywords: Raltegravir Lopinavir
Sponsor: George Washington University
Start date: 2008-02-01; Completion date: 2010-06-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.

Detailed description:
It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.

Arms: arm 1: Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) arm 2: Lopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD)
Interventions: intervention 1: Raltegravir intervention 2: Lopinavir/Ritonavir intervention 3: Truvada
Intervention descriptions: intervention 1: 1, 400mg tablet twice a day, with Truvada 1 tablet once a day intervention 2: 2 tablets twice a day, with Truvada 1 tablet once a day intervention 3: 1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)

Protocol documents:
Clinical trial NCT00634088
Conditions: Locally Advanced or Metastatic Breast Cancer
Sponsor: R-Pharm
Start date: 2008-06-01; Completion date: 2010-06-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and preliminary effectiveness of ixabepilone plus lapatinib with and without capecitabine in the treatment of human epidermal growth factor receptor 2 (HER2)-positive or metastatic breast cancer.

Detailed description:

Arms: arm 1: Dose Level 1 arm 2: Dose Level 2 arm 3: Dose Level 3 arm 4: Triplet Combination
Interventions: intervention 1: Ixabepilone, 32 mg/m^2 + Lapatinib, 1000 mg intervention 2: Ixabepilone, 32 mg/m^2 + Lapatinib, 1250 mg intervention 3: Ixabepilone, 40 mg/m^2 + Lapatinib, 1250 mg intervention 4: Ixabepilone + Lapatinib + Capecitabine
Intervention descriptions: intervention 1: Lapatinib, 1000 mg, administered orally, once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone (Day 1). Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib, 1000 mg, administered orally, once a day, every day, for a 21-day cycle. intervention 2: Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m\^2 + lapatinib, 1000 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 32 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib administered, 1250 mg, orally, once a day, every day, for a 21-day cycle. intervention 3: Initiated a minimum of 14 days following Day 1 of previous cohort (ixabepilone, 32 mg/m\^2 + lapatinib, 1250 mg). Lapatinib, 1250 mg, administered orally once a day, every day, for 7 to 14 consecutive days as a lead-in period prior to the first administration of ixabepilone. Following the lapatinib lead-in phase of Cycle 1, and on Day 1 of subsequent cycles, ixabepilone, 40 mg/m\^2, administered as a 3-hour IV infusion. Lapatinib, 1250 mg, administered orally, once a day, every day, for a 21-day cycle. intervention 4: Planned escalating doses of the triplet combination of ixabepilone, lapatinib, and capecitabine. No participants were enrolled in this arm due to premature termination of the study.

Protocol documents: