ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00171301
Conditions: Beta-thalassemia Major Hemosiderosis Iron Overload Rare Anemia
Keywords: Transfusional hemosiderosis Beta-thalassemia major Deferasirox iron overload rare anemia iron overload due to transfusion
Sponsor: Novartis Pharmaceuticals
Start date: 2005-06-01; Completion date: 2008-05-01
Enrollment: 233 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. To evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (LIC) and change in serum ferritin levels. Safety was mainly assessed by incidence of adverse events (AEs)and clinically significant lab parameters.

Detailed description:
Iron accumulation is an inevitable consequence of chronic blood transfusions and results in serious complications in the absence of chelation treatment to remove excess iron. Deferasirox (Exjade, ICL670) is an oral chelator with high iron-binding potency and selectivity. This extension study aimed at collecting efficacy and safety data during 2 years of treatment with deferasirox in the extension study or until deferasirox became commercially available in the countries where the centers were located, whichever came first. The population comprised of β-thalassemia patients with transfusional hemosiderosis who could not be satisfactorily treated with deferoxamine or deferiprone.

Arms: arm 1: Deferasirox was given orally once daily (10 to 20 mg/kg) to participants 2 years and older based on participant's body weight.
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: Deferasirox was administered orally once daily. Deferasirox was available as 125 mg, 250 mg, and 500 mg tablets.

Protocol documents:
Clinical trial NCT00176631
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer
Sponsor: Rutgers, The State University of New Jersey
Start date: 2007-09-01; Completion date: 2008-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Licorice root extract contains ingredients that may slow the growth of tumor cells. 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. Giving licorice root extract together with docetaxel may be an effective treatment for prostate cancer.

PURPOSE: This phase II trial is studying the side effects and how well giving licorice root extract together with docetaxel works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.

Detailed description:
OBJECTIVES:

Primary

* Determine the efficacy and toxicity of licorice root extract in combination with docetaxel in patients with hormone-refractory metastatic prostate cancer.

Secondary

* Determine the ability of licorice root extract to alter surrogate markers of estrogen activity and cytotoxicity in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral licorice root extract 3 times a day on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: licorice root extract intervention 2: docetaxel
Intervention descriptions: intervention 1: Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle. intervention 2: All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle.

Protocol documents:
Clinical trial NCT00185211
Conditions: Multiple Sclerosis
Sponsor: Bayer
Start date: 2002-08-01; Completion date: 2008-05-01
Enrollment: 468 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will primarily compare the long-term effects of an early and continued treatment with Betaferon/Betaseron (patients who were treated with active medication during the double-blind BENEFIT study) to treatment initiated either after Clinically Definite Multiple Sclerosis (CDMS) has been diagnosed or after two years (those patients who were treated with placebo during the double-blind BENEFIT study).

Analyses are based on the integrated data of the initial BENEFIT study and this follow-up study.

Detailed description:
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare Pharmaceuticals Inc..

Bayer HealthCare Pharmaceuticals Inc. is the sponsor of the trial.

Arms: arm 1: Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase arm 2: Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
Interventions: intervention 1: Interferon beta-1b (Betaseron, BAY86-5046) intervention 2: Interferon beta-1b (Betaseron, BAY86-5046)
Intervention descriptions: intervention 1: Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase intervention 2: Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)

Protocol documents:
Clinical trial NCT00185458
Conditions: Menopause
Sponsor: Bayer
Start date: 2000-05-01; Completion date: 2008-05-01
Enrollment: 394 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study has been designed to look at the transfer from using LNG IUS for contraception only, in reproductive age to using it for endometrial protection in menopausal age. The main area of interest in the study is the pattern of any vaginal bleeding that occurs.

Detailed description:
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Arms: arm 1: Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
Interventions: intervention 1: LNG IUS
Intervention descriptions: intervention 1: LNG IUS (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) HRT Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by WHO guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.

Protocol documents:
Clinical trial NCT00192023
Conditions: Attention Deficit Hyperactivity Disorder Oppositional Defiant Disorder
Sponsor: Eli Lilly and Company
Start date: 2004-10-01; Completion date: 2008-05-01
Enrollment: 139 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders to a previous psychological intervention with parent support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid conditions associated with ADHD and ODD will be assessed.

Detailed description:

Arms: arm 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval. arm 2: placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval.
Interventions: intervention 1: atomoxetine 0.5 mg/kg/day intervention 2: placebo intervention 3: atomoxetine 1.2 mg/kg/day intervention 4: atomoxetine 1.2-1.4 mg/kg/day
Intervention descriptions: intervention 1: atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) intervention 2: None intervention 3: atomoxetine 1.2 mg/kg/day QD, PO intervention 4: atomoxetine 1.2 - 1.4 mg/kg/day QD, PO

Protocol documents:
Clinical trial NCT00193375
Conditions: Lung Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2003-08-01; Completion date: 2008-05-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this multicenter trial, we plan to evaluate the feasibility and toxicity of initial treatment with irinotecan/carboplatin/radiation therapy, followed by treatment with bevacizumab, in patients with limited stage small cell lung cancer.

Detailed description:
Upon determination of eligibility, all patients will be receive:

* Irinotecan + Carboplatin + Radiation Therapy + Bevacizumab

Patients will receive 4 courses of irinotecan/carboplatin. Radiation therapy will begin concurrently with the third course of chemotherapy. The intervals between chemotherapy courses will be 21 days except for the interval between the third and fourth courses (during radiation therapy), which will be 28 days.

Arms: arm 1: Patients received carboplatin \[area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4\], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
Interventions: intervention 1: Irinotecan intervention 2: Carboplatin intervention 3: Bevacizumab intervention 4: Radiation
Intervention descriptions: intervention 1: 50mg/m2 days 1 \& 8 each 21-day cycle 1 \& 2, 28-day cycle 3 \& 4 intervention 2: AUC 5 intervention 3: 10mg/kg IV every 2 weeks for 10 doses starting week 16 intervention 4: None

Protocol documents:
Clinical trial NCT00224029
Conditions: Detrusor Hyperreflexia
Sponsor: Watson Pharmaceuticals
Start date: 2004-12-01; Completion date: 2008-05-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.

Detailed description:
The Dose Titration Period began with a 3.9 mg/day or 7.8 mg/day as a starting dose after the completion of a 3-day diary for baseline evaluations, including urodynamic testing. The clean intermittent catheterization (CIC) frequency remained constant throughout the Dose Titration Period. The dose was adjusted every two weeks during the Dose Titration Period by increasing one dose level, at the investigator's discretion, based on the patient's symptoms. If a patient achieved complete continence and reported tolerable or absence of side effects, the patient was continued at that dose for the duration of the 8-week Titration Period. If a patient reported unacceptable side effects, the dose was reduced by one level. This reduced dose was considered the maximum tolerable dose for the patient and the patient continued at that dose for the duration of the 8-week Titration Period. The dose levels evaluated were 3.9 mg/day, 7.8 mg/day, 9.1 mg/day, and 11.7 mg/day. Of the 22 subjects in the modified intent-to-treat population evaluated for efficacy, 0 were in the 3.9 mg/day dose group, 3 were in the 7.8 mg/day dose group, 8 were in the 9.1 mg/day dose group, and 11 were in the 11.7 mg/day dose group.

Arms: arm 1: Oxybutynin transdermal system 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day dosing
Interventions: intervention 1: Oxybutynin transdermal system
Intervention descriptions: intervention 1: 3.9 mg/day, 7.8 mg/day, 9.1 mg/day or 11.7 mg/day transdermal per titration

Protocol documents:
Clinical trial NCT00256451
Conditions: Healthy
Keywords: Naltrexone Alcohol
Sponsor: University of Pennsylvania
Start date: 2005-11-01; Completion date: 2008-05-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the study is to understand the relationship between what an individual inherited from their family (genetics), how they respond and feel after drinking alcohol, and how they respond to pre-treatment with naltrexone, a medication that blocks some of the effects of alcohol and is approved for the treatment of alcoholism. The investigators are conducting this study on those of African descent because there is almost no research focused on this group and the association with genetics. The investigators seek to enroll 40 people in the study. Participation will consist of 4 different alcohol challenge sessions in a cross over design. Each session will be separated by at least 10 days. In total, there will be four challenge sessions.

Detailed description:
We propose to test the degree to which specific genetic markers alter the relationship between subjective and objective measures of response to alcohol ingestion among non-alcohol dependent adults of African descent in a laboratory environment. To meet this aim, non-alcohol dependent adults of African descent will be recruited for participation to meet the N-goal of 40 trial completers. After consenting, genotyping, and completing the baseline assessment, they will participate in four separate alcohol challenge sessions separated by at least 10 days. During each of the sessions, subjects will be administered alcohol or sham drinking challenge sessions and pretreatment with either naltrexone (50 mg/day) or placebo in a double-blind fashion. The order of the four sessions will be randomly assigned. During each session, physiological and subjective response will be measured. We will select subjects to assure equal number of participants with at least one copy of the Val6 allele compared to those homozygous for the Ala6 allele.

Arms: arm 1: alcohol and active naltrexone arm 2: "sham" alcohol and active naltrexone arm 3: placebo naltrexone and alcohol arm 4: placebo naltrexone and placebo (non-alcoholic) alcohol
Interventions: intervention 1: Naltrexone intervention 2: placebo intervention 3: alcohol intervention 4: Sham alcohol
Intervention descriptions: intervention 1: 50 mg/day for two days prior to the alcohol challenge session intervention 2: placebo pills intervention 3: 190 proof alcohol prepared to 11% volume mixed with fruit juice. intervention 4: non-alcoholic placebo alcohol

Protocol documents:
Clinical trial NCT00258128
Conditions: Insulin Resistance
Sponsor: Joslin Diabetes Center
Start date: 2000-01-01; Completion date: 2008-05-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Data supports diet induced obesity leads to activation of the IKK/NF-kB inflamatory pathway and that chronic inflammation leads to insulin resistance and diabetes. In rodents, salicylates inhibit IKK/NF-kB and may improve insulin sensitivity. We will study if this is true in people.

Detailed description:
Please see the following review articles on this topic:

Shoelson SE, Lee J, Goldfine AB. (2006) Inflammation in insulin resistance. J. Clin. Invest. 116, 1793-1801.

Goldfine AB, Fonseca V and Shoelson SE (2010) Therapeutic approaches to target inflammation in type 2 diabetes. Clin Chem. 57, 162-167.

Donath MY and Shoelson SE (2011) Type 2 diabetes as an inflammatory disease. Nat Rev Immunol. 11, 98-107.

Goldfine AB and Shoelson SE (2017) Therapeutic approaches targeting inflammation for diabetes and associated cardiovascular risk. J Clin Invest. 127, 83-93.

Arms: arm 1: This third small study has a randomized, masked, placebo controlled parallel design to compare salsalate 4.0 g/d to placebo. This is the salsalate 4.0 g/d arm. arm 2: This third small study has a randomized, masked, placebo controlled parallel design to compare salsalate 4.0 g/d to placebo. This is the placebo arm.
Interventions: intervention 1: Salsalate intervention 2: Placebo
Intervention descriptions: intervention 1: Active intervention 2: Placebo for salslate, used only in the third trial

Protocol documents:
Clinical trial NCT00262860
Conditions: Lymphoma
Keywords: recurrent adult Hodgkin lymphoma
Sponsor: University of Rochester
Start date: 2005-04-01; Completion date: 2008-05-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with gemcitabine hydrochloride may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving bortezomib together with gemcitabine hydrochloride works in treating patients with relapsed or refractory Hodgkin's lymphoma.

Detailed description:
OBJECTIVES:

Primary

* Determine the overall response rate (partial and complete response) in patients with relapsed or refractory Hodgkin's lymphoma treated with bortezomib and gemcitabine hydrochloride.

Secondary

* Determine the safety and toxic effects of this regimen in these patients.
* Determine the time to progression in patients treated with this regimen.
* Correlate NF-kB inhibition and proteasome activity with response in patients treated with this regimen.

OUTLINE: This is a multicenter, pilot study.

Patients receive bortezomib IV on days 1, 4, 8, and 11 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Arms: arm 1: None
Interventions: intervention 1: bortezomib intervention 2: gemcitabine hydrochloride
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00267020
Conditions: Pancreatic Neoplasm
Sponsor: Eli Lilly and Company
Start date: 2005-12-01; Completion date: 2008-05-01
Enrollment: 130 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine the effects and toxicity of gemcitabine alone or gemcitabine plus enzastaurin in participants with pancreatic cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: enzastaurin intervention 2: gemcitabine
Intervention descriptions: intervention 1: 1200 milligrams (mg) loading dose then 500 mg, orally, daily, six 28-day cycles intervention 2: 1000 milligrams/square meter (mg/m\^2), intravenously on Days 1, 8 and 15 per cycle, six 28-day cycles

Protocol documents:
Clinical trial NCT00273754
Conditions: Sleep Apnea, Obstructive Tonsillectomy Adenoidectomy Postoperative Complications
Keywords: Obstructive Sleep Apnea (OSA) Tonsillectomy and Adenoidectomy (T&A) Postoperative Complications Recovery
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2003-09-01; Completion date: 2008-05-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a research study using caffeine in children who have an obstructive sleep apnea (OSA). OSA means children who stop breathing during their sleep due to obstruction in their airway. The purpose of this study is to determine whether caffeine when given in the vein, will wake children up faster and decrease post-anesthesia airway obstruction, as well as the safety and if the drug agrees with the child compared to a placebo (an inactive or dummy agent).

Detailed description:
Patients with OSA are reported to have a higher rate of severe respiratory complications associated with upper airway obstruction during anesthesia and sedation or immediately after anesthesia. Children with OSA (especially those under three years of age, those with severe OSA, cerebral palsy or craniofacial anomalies) are at increased risks for post-operative complications, and require careful monitoring post-operatively.

Although the etiology of obstructive sleep apnea is mainly obstruction due to anatomical and neuromuscular abnormalities, we believe that a central element may contribute to OSA.

The aim of this study is to evaluate whether administration of caffeine to children with OSA, scheduled for elective T \& A under general anesthesia contributes to a faster recovery, less post-operative complications, and a shorter stay in the PACU, DSU and the hospital.

Arms: arm 1: Saline arm 2: Caffeine benzoate
Interventions: intervention 1: Caffeine intervention 2: Placebo
Intervention descriptions: intervention 1: Children in group one will receive caffeine benzoate 20 mg/kg i.v., which is equal to a 10 mg/kg caffeine base. intervention 2: Children in group two will receive an amount of normal saline equal to Caffeine

Protocol documents: