ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00230802
Conditions: Pregnancy Hypothyroidism
Keywords: pregnancy hypothyroidism levothyroxine
Sponsor: Brigham and Women's Hospital
Start date: 2005-07-01; Completion date: 2010-07-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy.

Detailed description:
Our aim is to compare the safety and efficacy of 2 different empiric levothyroxine dose adjustment recommendations to be made at the first confirmation of pregnancy in women with a history of hypothyroidism. Subjects will be women with a prior diagnosis of hypothyroidism who are taking thyroid hormone replacement and who are less than 8 weeks pregnant. Upon confirmation of pregnancy, subjects will be randomized to increase their weekly thyroid hormone dose by either 2 or 3 tablets (28 or 42%). Thyroid function will be evaluated every two weeks in the first 20 weeks and then again at week 30 and post-partum. Primary endpoints will be the proportion of women in each group who remain euthyroid throughout the first trimester and throughout pregnancy

Arms: arm 1: Patients will increase their current levothyroxine dose by 2 extra tablets per week (\~29% increase) arm 2: Patients will increase their levothyroxine dosage by 3 extra tablets per week (\~43%).
Interventions: intervention 1: Anticipatory dose increase of levothyroxine intervention 2: levothyroxine intervention 3: levothyroxine
Intervention descriptions: intervention 1: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts. intervention 2: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week intervention 3: patients will increase levothyroxine by 3 extra tablets of their current dose per week.

Protocol documents:
Clinical trial NCT00238121
Conditions: Recurrent Uterine Sarcoma Stage III Uterine Sarcoma Stage IV Uterine Sarcoma Uterine Carcinosarcoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-02-01; Completion date: 2010-07-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
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. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with advanced or recurrent uterine cancer treated with sorafenib.

II. Determine the toxic effects of this drug in these patients.

SECONDARY OBJECTIVES:

I. Determine progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to histology (carcinoma vs carcinosarcoma).

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

Arms: arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00243503
Conditions: Breast Neoplasms
Keywords: Breast Cancer Metastatic
Sponsor: Pfizer
Start date: 2006-02-01; Completion date: 2010-07-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SU011248/Trastuzumab
Intervention descriptions: intervention 1: SU011248 will be administered orally, starting dose of 37.5 mg daily on a continuous regimen. Trastuzumab will be administered weekly (loading dose 4 mg/kg followed by weekly 2mg/kg) or every 3 weeks (loading dose 8 mg/kg followed by 6mg/kg q3w). Study treatment should continue until progression, withdrawal for other reasons, or for up to 18 months following which patients requiring continued access will be offered SU011248 on a separate protocol.

Protocol documents:
Clinical trial NCT00286221
Conditions: Intracranial Surgery
Sponsor: Johns Hopkins University
Start date: 2006-03-01; Completion date: 2010-07-01
Enrollment: 159 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized controlled clinical trial to evaluate the efficacy and safety of intravenous patient controlled analgesia (IVPCA) in patients following major intracranial surgery (e.g. brain tumors, vascular surgery). We will compare pain, opioid consumption, costs, sedation level, length of hospital stay, patient satisfaction, and complications in patients randomized to receive either pro re nata (PRN) or IVPCA opioids. We hypothesize that IVPCA will be more efficacious than PRN opioids in the treatment of postoperative without an increased incidence of adverse effects.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: PCA fentanyl intervention 2: PRN fentanyl
Intervention descriptions: intervention 1: PCA fentanyl 0.5 ug/kg with a dosing interval ("lockout") of 15 minutes and a maximal permitted dosage of 4 demand doses per hour, according to their randomized preoperative assignment. The PCA pump (CADD-Solis Ambulatory Infusion Pump; Smiths Medical, Dublin, OH) had a preprogrammed dose limit of 50 ug fentanyl, and this was the maximal PCA dose permitted intervention 2: IV fentanyl 25 to 50 ug every 30 minutes PRN (the maximal routine dose permitted in our Neurosciences Critical Care Unit (NCCU))

Protocol documents:
Clinical trial NCT00312845
Conditions: Non-Hodgkin's Lymphoma
Keywords: B-cell Non-Hodgkin's Lymphoma
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2006-03-01; Completion date: 2010-07-01
Enrollment: 676 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the combination of VELCADE and rituximab improves progression free survival relative to rituximab alone in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma (B-NHL) who never received rituximab or who have previously responded to rituximab. This is an international study being conducted in the United States and in many countries around the world. A complete list of study locations is listed below.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Bortezomib + Rituximab intervention 2: Rituximab
Intervention descriptions: intervention 1: VELCADE for Injection will be administered weekly on Days 1,8,15, and 22 of a 35-day cycle in combination with 4 doses of rituximab once a week on Days 1,8,15, and 22 of Cycle 1 and in combination with a single dose of rituximab on Day 1 of Cycles 2 to 5. intervention 2: rituximab once a week on Days 1,8,15, and 22 of Cycle 1, and as a single dose on Day 1 of Cycles 2 to 5 (for a total of 8 doses).

Protocol documents:
Clinical trial NCT00319046
Conditions: Gaucher Disease Type 1
Keywords: enzyme replacement therapy Type 1 Gaucher Disease miglustat
Sponsor: Actelion
Start date: 2006-02-01; Completion date: 2010-07-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Although miglustat has been approved as a treatment for mild to moderate type 1 Gaucher disease in patients who are unsuitable for enzyme replacement therapy (ERT), more data are required to establish the long term efficacy, safety and tolerability of miglustat in maintaining diseases stability after a switch from ERT.

Detailed description:

Arms: arm 1: Oral administration of miglustat 100 mg t.i.d. for a period of 2 years
Interventions: intervention 1: Miglustat
Intervention descriptions: intervention 1: Oral capsules containing miglustat 100 mg, administered three times daily (t.i.d.)

Protocol documents:
Clinical trial NCT00325897
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: University of Minnesota
Start date: 2006-03-01; Completion date: 2010-07-01
Enrollment: 1142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).

Detailed description:
BACKGROUND:

The prevalence, morbidity, mortality, and treatment cost of COPD are high and increasing. COPD is the sixth leading cause of death worldwide and is the only condition in the top 10 causes of death that has an increasing prevalence and mortality. The cost of health care for patients with COPD in the U.S. is approximately $6.5 billion per year; acute exacerbations account for between 31% and 68% of that cost. Macrolide antibiotics may reduce the frequency and/or severity of COPD exacerbations, as a result of their antibacterial properties and anti-inflammatory effects. Long-term administration of macrolide antibiotics in patients with a number of other pulmonary disorders has resulted in clinically important improvements. It is hypothesized that administration of a macrolide antibiotic (azithromycin) for 1 year, when added to usual care, will decrease the frequency and severity of COPD exacerbations. If this hypothesis is correct, the proposed treatment is also expected to reduce the mortality of COPD patients.

DESIGN NARRATIVE:

This is a prospective, randomized, double-blind, placebo-controlled study that will enroll 1130 patients with at least moderately severe COPD who, based on clinical indicators, have an increased likelihood of experiencing an acute exacerbation during the study period. Patients will be monitored monthly, including careful assessments of possible macrolide-related side effects. The exclusion criteria for this study will include a variety of conditions or medications that are known to adversely interact with macrolides. The primary endpoint of this study is time until the first acute COPD exacerbation. The secondary endpoints include macrolide-related side effects, the incidence of macrolide-resistant bacterial colonization, quality of life, and cost-effectiveness.

Arms: arm 1: Macrolide Antibiotic (Azithromycin) arm 2: Inactive
Interventions: intervention 1: Macrolide Antibiotic (Azithromycin) intervention 2: Placebo
Intervention descriptions: intervention 1: Azithromycin (daily capsule, 250 mg for 12 months) intervention 2: Placebo taken on a daily basis

Protocol documents:
Clinical trial NCT00343564
Conditions: Non-Hodgkin's Lymphoma Hodgkin's Disease
Sponsor: Cytokinetics
Start date: 2006-04-01; Completion date: 2010-07-01
Enrollment: 68 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study was an early-phase trial arranged into two phases. The Phase I portion was a dose-escalation study designed to assess the safety, tolerability and to identify the maximum tolerated dose of SB-743921 in patients with Non-Hodgkin Lymphoma and Hodgkin Lymphoma. Phase II was intended to assess the activity, safety and tolerability of SB-743921 in patients with Indolent and Aggressive Non-Hodgkin's Lymphomas exclusively. The Phase II portion of the study was not initiated.

Detailed description:

Arms: arm 1: Phase 1 dose escalation without and with GCSF support arm 2: Phase 2 fixed dose based on Phase I findings stratified by NHL type
Interventions: intervention 1: SB-743921 intervention 2: SB-743921
Intervention descriptions: intervention 1: Phase 1: I.V. dose on Days 1 and 15 of a 28 day cycle starting at 2mg/m2 and increasing by 1 mg/m2 with possible prophylactic granulopoietic support until unacceptable toxicity develops. intervention 2: Phase 2: I.V. dose and regimen will be determined based on Phase 1 findings.

Protocol documents:
Clinical trial NCT00355368
Conditions: Intubation
Keywords: intubation intensive care neuromuscular depolarizing agents neuromuscular nondepolarizing agents neuromuscular blocking agents
Sponsor: University Hospital, Basel, Switzerland
Start date: 2006-08-01; Completion date: 2010-07-01
Enrollment: 420 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Emergency intubation of patients in intensive care is a high-risk endeavour. For many decades, succinylcholine has been the neuromuscular blocking agent of choice. However, succinylcholine may have life-threatening side effects and is contraindicated in a variety of diseases relevant in intensive care. The nondepolarizing agent rocuronium has been propagated as alternative for succinylcholine. Though a recent meta-analysis found no difference in intubating conditions between succinylcholine and rocuronium in elective cases, there are no data in emergent cases in intensive care. The aim of the present study is to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.

Detailed description:
Objective: to compare succinylcholine and rocuronium with regard to 1) quality of intubating conditions, 2) length of the intubating sequence, 3) failed intubating attempts, 4) hemodynamic sequelae of intubation, and 5) desaturations.

Design: prospective, randomized, single-blind study. Setting: Intensive care units of an University Hospital. Patients: adult patients in intensive care requiring emergency intubation. Randomization: 1:1 randomization to either succinylcholine (1mg/kg) or rocuronium (0.6 mg/kg).

Data: 1) assessment of the quality of intubating conditions by means of a score, 2) length of the intubating sequence defined as time between injection of neuromuscular blocking agent and first end-tidal CO2 on the monitor, 3) number of failed intubating attempts, 4) hemodynamic sequelae of intubation, defined as events requiring injection of vasoactive drugs, and 5) desaturations, defined as saturation below 90% and/or any decrease in saturation of 5% or more.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Succinylcholine intervention 2: Rocuronium
Intervention descriptions: intervention 1: 1mg/kg iv intervention 2: 0.6mg/kg iv

Protocol documents:
Clinical trial NCT00357032
Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Del(5q) Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Adult Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2006-05-01; Completion date: 2010-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. Evaluate the response rate (complete response and partial response) in patients with acute myeloid leukemia treated with PXD101.

SECONDARY OBJECTIVES:

I. Evaluate the overall survival of these patients. II. Evaluate the duration of response in these patients. III. Evaluate the toxicity of this drug in these patients.

TERTIARY OBJECTIVES:

I. Evaluate molecular response to PXD101.

OUTLINE:

Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.

Blood and bone marrow samples are obtained before and after study treatment for laboratory studies.

After completion of study treatment, patients are followed periodically for 1 year.

Arms: arm 1: Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: belinostat intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00362882
Conditions: Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2006-07-01; Completion date: 2010-07-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is studying two different schedules of docetaxel and bortezomib to compare how well they work in treating patients with progressive or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving docetaxel together with bortezomib may kill more tumor cells

Detailed description:
PRIMARY OBJECTIVE:

I. To compare the efficacy and tolerability of sequential vs concurrent docetaxel and bortezomib in patients with previously treated, progressive or recurrent, advanced non-small cell lung cancer (NSCLC).

SECOND OBJECTIVES:

I. To compare time to progression in patients with previously treated NSCLC treated with these regimens.

II. To compare 1-year and overall survival of patients treated with these regimens.

III. To compare the toxicity of these regimens in these patients. IV. To determine the pharmacokinetics of docetaxel in the context of this study.

TERTIARY OBJECTIVE:

I. To determine levels of expression of molecular markers regulated by docetaxel and bortezomib and correlate with clinical response and overall survival of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 vs 1) and number of prior chemotherapy treatments (1 vs \>1). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically.

Arms: arm 1: Patients receive docetaxel IV over 60 minutes on day 1 and bortezomib IV over 3-5 seconds on days 1 and 8. arm 2: Patients receive docetaxel as in arm I and bortezomib IV over 3-5 seconds on days 2 and 8.
Interventions: intervention 1: docetaxel intervention 2: bortezomib intervention 3: laboratory biomarker analysis intervention 4: immunoenzyme technique intervention 5: immunohistochemistry staining method intervention 6: pharmacological study
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: correlative study intervention 4: correlative study intervention 5: correlative study intervention 6: correlative study

Protocol documents:
Clinical trial NCT00363311
Conditions: Neoplasms, Prostate
Keywords: Dutasteride Prostate Cancer Expectant management REDEEM
Sponsor: GlaxoSmithKline
Start date: 2006-07-01; Completion date: 2010-07-01
Enrollment: 302 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).

Detailed description:

Arms: arm 1: Dutasteride 0.5mg arm 2: Matching placebo
Interventions: intervention 1: Dutasteride intervention 2: Matching placebo
Intervention descriptions: intervention 1: Dutasteride 0.5mg intervention 2: Matching placebo

Protocol documents:
Clinical trial NCT00383435
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Organon and Co
Start date: 2006-10-01; Completion date: 2010-07-01
Enrollment: 1055 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated

subjects who will not participate in the safety extension will be discontinued

and will have their Final Visit at Week 26. Subjects who continue into the

26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC\[0-12hr\]) and change from Baseline to Week 13 in AM predose FEV1.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Mometasone furoate/formoterol (MF/F) combination intervention 2: Mometasone furoate/formoterol (MF/F) combination intervention 3: Mometasone furoate MDI (MF MDI) intervention 4: Formoterol MDI intervention 5: Placebo
Intervention descriptions: intervention 1: MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 2: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 52 weeks intervention 3: MF 400 mcg via metered dose inhaler twice daily for 52 weeks intervention 4: Formoterol 10 mcg via metered dose inhaler twice a day for 52 weeks intervention 5: Placebo MDI twice a day for 26 weeks

Protocol documents: