ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00187135
Conditions: Bone Marrow Disease Pain
Keywords: Pain Management Bone Marrow Aspiration
Sponsor: St. Jude Children's Research Hospital
Start date: 2002-03-01; Completion date: 2008-08-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with applying the skin-numbing-cream EMLA or L.M.X4™ on the area where the procedure is performed, will provide better pain control.

Each patient enrolled on this study will have three different anesthetic combinations for three different procedures, in order to determine which combination worked best for each child.

Detailed description:
The study focusses on the following primary aims:

* To compare 0.5 mg/kg versus 1.0 mg/kg of fentanyl to control pain in patients who have a BMT/LPIT procedure in the context of propofol anesthesia and topical anesthesia with EMLA or L•M•X 4™cream (or when necessary, lidocaine for injection).
* To compare placebo versus fentanyl (0.5 mg/kg or 1.0 mg/kg) in these same patients. The first BMT/LPIT for which patients receive any fentanyl will be used in this comparison.

The study focusses on the following secondary aims:

* To determine which dose regimen ensures best conditions to perform bone marrow aspiration (lack of motion) and maintains hemodynamic and respiratory stability as indicators of adequate levels of analgesia during bone marrow aspiration.
* To evaluate the safety and complications for each dose regimen.

Arms: arm 1: Fentanyl-1mcg/kg in 3 ml of Normal Saline arm 2: Fentanyl - 0.5 mcg/kg in 3 ml normal saline arm 3: normal saline
Interventions: intervention 1: Fentanyl intervention 2: EMLA intervention 3: L.M.X4 intervention 4: Propofol
Intervention descriptions: intervention 1: 1. Fentanyl - 1 mcg/kg in 3 ml normal saline
2. Fentanyl - 0.5 mcg/kg in 3 ml normal saline intervention 2: All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours. intervention 3: All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes. intervention 4: Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex.

Protocol documents:
Clinical trial NCT00229203
Conditions: Multiple Myeloma
Keywords: Myeloma Aplidin Plitidepsin PharmaMar
Sponsor: PharmaMar
Start date: 2005-02-01; Completion date: 2008-08-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 hours intravenous infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM).

Detailed description:
This is a phase II study to determine the efficacy following treatment with Aplidin® 5 mg/m2, given as a 3 h iv infusion every 2 weeks, in patients with relapsed or refractory multiple myeloma (MM) and to obtain the following :

* Additional pharmacokinetic information for Aplidin® given as 3-hour IV infusion every 2 weeks in patients with MM.
* To obtain additional genomic and pharmacodynamics information on MM and Aplidin.
* To assess the safety and tolerability of Aplidin® given as 3-hour IV infusion every 2 weeks in patients with MM alone or in combination with dexamethasone given orally as a 20 mg daily for 4 days
* To determine the response rate in the second cohort of patients following treatment with Aplidin®, given as a 3 hour infusion every 2 weeks, plus dexamethasone given orally as a 20 mg daily for 4 days, starting the same day of Aplidin® administration, as a second treatment stage in patients with suboptimal response to Aplidin® as single agent (progressive disease after three cycles or stable disease after four cycles).

Interventions: intervention 1: Plitidepsin
Intervention descriptions: intervention 1: 3-hour infusion every 2 weeks alone or in combination with dexamethasone

Protocol documents:
Clinical trial NCT00243867
Conditions: Non-Small Cell Lung Cancer
Keywords: Advanced Non-Small Cell Lung Cancer
Sponsor: American Regent, Inc.
Start date: 2005-11-01; Completion date: 2008-08-01
Enrollment: 518 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this trial is to compare the survival of patients with advanced non-small cell lung cancer (NSCLC) treated with weekly Taxoprexin in combination with carboplatin to those treated with paclitaxel plus carboplatin in a prospectively randomized trial. In addition, the response rate to each regimen, response duration, time to progression and time to treatment failure will be measured. Toxicity will be evaluated and compared between the two groups.

Detailed description:
This is a randomized, multicenter, Phase III open-label study of weekly Taxoprexin® in combination with every three (3) week carboplatin compared to paclitaxel plus carboplatin every three (3) weeks, in patients with advanced non-small cell lung cancer (NSCLC) who have not received cytotoxic agents for advanced disease. Patients may have been previously treated with immunological agents. Patients will be randomized to receive Taxoprexin® at a dose of 400 mg/m2 intravenously by one (1)-hour weekly infusion, 5/6 weeks followed immediately by carboplatin AUC = 4 on weeks one (1) and four (4) as a 30 minute intravenous infusion or paclitaxel 225mg/m2 as a three (3) hour intravenous infusion followed immediately by carboplatin AUC = 6 as a 30 minute intravenous infusion, every three (3) weeks. Patients will receive Taxoprexin® and carboplatin infusions or paclitaxel and carboplatin infusions until progression of disease, intolerable toxicity, completion of six (6) treatment cycles of paclitaxel plus carboplatin or three (3) treatment cycles of Taxoprexin® plus carboplatin, refusal of continued treatment by the patient, or Investigator decision.

Arms: arm 1: Taxoprexin® 400 mg/m² intravenously weekly for 5 weeks

Carboplatin was given at an Area Under the Curve (AUC) = 4 mg\*min/mL on Week 1 and Week 4, Taxoprexin and carboplatin were given up to 3 treatment cycles. arm 2: Paclitaxel 225 mg/m² intravenously followed immediately by carboplatin AUC = 6 mg\*min/mL. Paclitaxel and carboplatin were given up to 6 treatment cycles.
Interventions: intervention 1: Taxoprexin intervention 2: Carboplatin intervention 3: Paclitaxel
Intervention descriptions: intervention 1: Administered by intravenous infusion over 1 hour infusion intervention 2: Administered by intravenous infusion over 30 minutes. Dosing was based on the Calvert formula: carboplatin dose (mg) = (Target AUC) x (glomerular filtration rate (GFR) + 25). intervention 3: Administered by intravenous infusion over 3 hour infusion

Protocol documents:
Clinical trial NCT00245557
Conditions: Major Depressive Disorder
Keywords: Depression Geriatric MRI Sertraline
Sponsor: Mclean Hospital
Start date: 2004-11-01; Completion date: 2008-08-01
Enrollment: 43 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to use Magnetic Resonance Images to further our understanding of predictors and markers of treatment response and non-response in geriatric depression. We hypothesized that concentrations of high energy metabolites would be lower in depressed elderly compared to non-depressed.

Detailed description:

Arms: arm 1: Healthy Controls undergo MRI and neuropsychological testing arm 2: Depressed subjects receive experimental drug
Interventions: intervention 1: Sertraline
Intervention descriptions: intervention 1: Oral Sertraline Dosage started at 25 mg a day, with increases up to maximum dosage strength of 200 mg a day.

Duration of treatment was 12 weeks.

Protocol documents:
Clinical trial NCT00249379
Conditions: Alcohol Dependence
Keywords: Alcohol dependence Acamprosate(drug) Drug Court Probation Parole Criminal justice
Sponsor: Virginia Commonwealth University
Start date: 2005-06-01; Completion date: 2008-08-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).

Detailed description:
Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole.

Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.

Arms: arm 1: Subjects randomized to receive acamprosate arm 2: No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling
Interventions: intervention 1: Acamprosate
Intervention descriptions: intervention 1: Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence

Protocol documents:
Clinical trial NCT00259649
Conditions: Migraine
Sponsor: University of Pittsburgh
Start date: 2004-08-01; Completion date: 2008-08-01
Enrollment: 71 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Detailed description:
Women are followed prospectively for 3 months, recording headaches, other symptoms, and menstrual periods. Those with menstrual migraine are treated perimenstrually with eletriptan for 3 months.

Interventions: intervention 1: eletriptan
Intervention descriptions: intervention 1: oral eletriptan 20 mg three times a day beginning 2 days before the expected onset of menstrual flow and continued for a total of 6 days

Protocol documents:
Clinical trial NCT00266695
Conditions: Diabetic Retinopathy
Sponsor: Chromaderm, Inc.
Start date: 2006-01-01; Completion date: 2008-08-01
Enrollment: 203 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ruboxistaurin
Intervention descriptions: intervention 1: 32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.

Protocol documents:
Clinical trial NCT00269919
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia Risperidone Risperidal Consta
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2005-08-01; Completion date: 2008-08-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description:
This is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale (PANSS) score. Participants' quality of life and safety will be monitored throughout the study.

Arms: arm 1: The RLAI 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 2 years.
Interventions: intervention 1: Risperidone Long-Acting Injectable (RLAI)
Intervention descriptions: intervention 1: The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.

Protocol documents:
Clinical trial NCT00272961
Conditions: Resistant Hypertension
Sponsor: Pfizer
Start date: 2006-01-01; Completion date: 2008-08-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study was to determine the safe and effective dose of TBC3711 in patients with uncontrolled high blood pressure while already taking blood pressure medications.

Detailed description:
The study was stopped due to Pfizer (sponsor) decision that the compound would not be involved in any further clinical development for the indication of resistant hypertension on 05 August 2008. This decision was not based on any safety or efficacy concern.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: TBC3711 intervention 3: TBC3711 intervention 4: TBC3711 intervention 5: TBC3711
Intervention descriptions: intervention 1: placebo tablet once daily for 12 weeks intervention 2: 10 mg tablets once daily for 10 weeks intervention 3: 50 mg tablet once daily for 10 weeks intervention 4: 100 mg tablet once daily for 10 weeks intervention 5: 200 mg tablet once daily for 10 weeks

Protocol documents:
Clinical trial NCT00290771
Conditions: Recurrent Glioblastoma Multiforme (GBM)
Keywords: imatinib mesylate hydroxyurea protein tyrosine kinases glioma glioblastoma multiforme recurrent glioblastoma multiforme GBM MacDonald criteria
Sponsor: Novartis
Start date: 2006-02-01; Completion date: 2008-08-01
Enrollment: 231 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an investigational study to assess the objective overall response (OOR) rate (complete response \[CR\] + partial response \[PR\]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with recurrent glioblastoma multiforme (brain tumors). This study also evaluated the duration of tumor response (as per MacDonald criteria), clinical benefit, progression-free survival rate at 6 and 12 months, and the survival rate at 12 and 24 months.

Detailed description:
This ClinicalTrials.gov record includes the results from two studies (Novartis protocol IDs CSTI571H2201 and CSTI571H2202) which were conducted separately but reported together in a single clinical study report. Both studies were phase II, open-label, multicenter, single-arm studies that evaluated the efficacy of imatinib mesylate plus hydroxyurea in subjects with progressive glioblastoma multiforme. The studies were identical in design with two exceptions: Patients in study CSTI571H2201 received a dose of imatinib 600 mg once daily and were not allowed concomitant use of enzyme-inducing anticonvulsant drugs (EIACDs); patients in study CSTI571H2202 received a dose of imatinib 500 mg twice daily and were allowed concomitant use of EIACDs.

Arms: arm 1: Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs. arm 2: Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
Interventions: intervention 1: Imatinib tablets intervention 2: Hydroxyurea capsules
Intervention descriptions: intervention 1: Imatinib was supplied as 100 and 400 mg tablets by Novartis. intervention 2: Hydroxyurea was supplied locally as 500 mg capsules.

Protocol documents:
Clinical trial NCT00293813
Conditions: Postmenopausal Osteoporosis
Keywords: Post Menopausal Osteoporosis MicroCT Amgen denosumab Extreme CT XCT Fosamax Alendronate
Sponsor: Amgen
Start date: 2006-05-01; Completion date: 2008-08-01
Enrollment: 247 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is structured to estimate the effect of denosumab, compared to placebo and alendronate, on several bone parameters.

Detailed description:

Arms: arm 1: Placebo for denosumab and placebo for alendronate arm 2: denosumab and placebo for alendronate arm 3: Placebo for denosumab and alendronate
Interventions: intervention 1: Alendronate intervention 2: Denosumab intervention 3: Placebo
Intervention descriptions: intervention 1: Alendronate 70 mg PO QW intervention 2: denosumab 60 mg SC q 6 mos intervention 3: Placebo for alendronate and placebo for denosumab

Protocol documents:
Clinical trial NCT00297115
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast COPD Chronic obstructive pulmonary disease
Sponsor: AstraZeneca
Start date: 2006-03-01; Completion date: 2008-08-01
Enrollment: 1568 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to compare the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will be up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Detailed description:

Arms: arm 1: 500 mcg, once daily, oral administration in the morning arm 2: once daily
Interventions: intervention 1: Roflumilast intervention 2: Placebo
Intervention descriptions: intervention 1: 500 mcg, once daily, oral administration in the morning intervention 2: once daily

Protocol documents:
Clinical trial NCT00300677
Conditions: Infections, Fungal
Keywords: Pharmacokinetics Voriconazole Magnetic Resonance Spectroscopy
Sponsor: Pfizer
Start date: 2007-03-01; Completion date: 2008-08-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.

Detailed description:

Arms: arm 1: voriconazole twice daily
Interventions: intervention 1: voriconazole
Intervention descriptions: intervention 1: Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily

Protocol documents:
Clinical trial NCT00308308
Conditions: Diabetes, Type I
Sponsor: Mannkind Corporation
Start date: 2006-02-01; Completion date: 2008-08-01
Enrollment: 589 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Detailed description:

Arms: arm 1: Technosphere Insulin arm 2: Rapid-acting analogue insulin plus basal insulin glargine
Interventions: intervention 1: Technosphere Insulin intervention 2: Active comparator
Intervention descriptions: intervention 1: Inhalation, 15U/30U intervention 2: sc injectable insulin

Protocol documents:
Clinical trial NCT00310765
Conditions: Abdominal Pain Surgical Adhesions
Keywords: abdominal pain surgical adhesions
Sponsor: Henry Ford Health System
Start date: 2006-03-01; Completion date: 2008-08-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate if pregabalin demonstrates significant reduction in abdominal pain from adhesions.

Detailed description:
The study will be prospective, double-blinded and randomized. The study will run for 12 weeks. During the first 7 weeks there will be 2 groups in the study with subjects receiving a placebo or the study drug. During the last 4 weeks of the study, all subjects will be offered the study medication, pregabalin. The primary outcome measure will be pain relief documented by a 2-point change on the Likert pain scale with a secondary pain measure of sleep interruption.

Arms: arm 1: Patients were randomly assigned to active drug 75-150 mg of pregabalin po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study. arm 2: Patients were randomly assigned to look alike placebo 75 or 150 mg po BID for 7 weeks followed by a 1 week wash out phase and then were given 150 mg of pregabalin BID for an additional 4 weeks. Daily pain and sleep scores were reported by the patient throughout the study.
Interventions: intervention 1: Pregabalin 75 or 150 mg BID for 7 weeks followed by open label pregabalin 150 mg BID for 4 weeks intervention 2: Placebo first followed by open label pregabalin
Intervention descriptions: intervention 1: First 7 weeks 75 or 150 mg of pregabalin po BID. Start at 75 mg and increase to 150 mg po BID if no improvement after 3 days and treat for 7 weeks. Followed by open label pregabalin for 4 weeks at 150 mg BID intervention 2: Look alike placebo 75 mg po BID and increase to 150 mg BID after 3 days if no improvement for 7 weeks. Open label pregabalin 150 mg BID for last 4 weeks of study.

Protocol documents: