ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00844844
Conditions: Atypical Hemolytic Uremic Syndrome
Keywords: aHUS
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2009-05-01; Completion date: 2013-07-01
Enrollment: 1 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether eculizumab is safe and effective in the treatment of adolescent patients with plasma therapy-resistant Atypical Hemolytic-Uremic Syndrome (aHUS).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Eculizumab
Intervention descriptions: intervention 1: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.

Protocol documents:
Clinical trial NCT00866840
Conditions: Melanoma (Skin)
Keywords: stage III melanoma stage IV melanoma recurrent melanoma
Sponsor: Rutgers, The State University of New Jersey
Start date: 2009-04-01; Completion date: 2013-07-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.

PURPOSE: This phase II trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* Determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by RECIST criteria, in patients with advanced melanoma.

Secondary

* Determine the long-term toxicity of riluzole when administered to these patients.
* Compare the survival of these patients with historical controls.

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

Arms: arm 1: 100 mg orally twice daily
Interventions: intervention 1: riluzole
Intervention descriptions: intervention 1: 100 mg orally twice daily

Protocol documents:
Clinical trial NCT00908596
Conditions: Contrast Media
Keywords: Nephrogenic Systemic Fibrosis (NSF) Primovist / Eovist
Sponsor: Bayer
Start date: 2009-05-01; Completion date: 2013-07-01
Enrollment: 357 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Patients with moderate to severe renal impairment scheduled for a magnetic resonance imaging (MRI) scan and injection with a contrast agent, Primovist/Eovist, will be asked to participate.

The administration of contrast agents that contain gadolinium such as Primovist/Eovist might increase a potential risk to develop a rare condition called nephrogenic systemic fibrosis (NSF) in patients with renal impairment. This study is to assess the potential risk to develop NSF in patients with renal impairment after the administration of Primovist/Eovist.

Patients who are enrolled in this study will receive a Primovist/Eovist enhanced MRI scan which was prescribed by the referring doctor. After the MRI scan the patient will be included in a two year follow-up period to assess if signs or symptoms suggestive of NSF have appeared.

Detailed description:
Adverse events data will be reported in Adverse Events section.

Arms: arm 1: Participants received Primovist at a dose of 0.025 mmol/kg body weight (BW) intravenously.
Interventions: intervention 1: Gadoxetic acid disodium (Primovist, BAY86-4873)
Intervention descriptions: intervention 1: Primovist/Eovist in approved indications at approved dosages

Protocol documents:
Clinical trial NCT00910091
Conditions: Endometrial Cancer
Keywords: Endometrial cancer Antitumour efficacy in women with advanced endometrial cancer
Sponsor: Ipsen
Start date: 2009-08-01; Completion date: 2013-07-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will explore the safety and efficacy of BN83485 compared to Megestrol Acetate (MA) on progression free survival (PFS) in post menopausal patients with endometrial cancer.

Detailed description:
The Primary Objective in this study is to determine the antitumour efficacy of BN83495 measured by the percentage of women with advanced or recurrent endometrial cancer who have neither progressed nor died after 6 months of treatment.

Arms: arm 1: After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service arm 2: After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service
Interventions: intervention 1: BN83495 intervention 2: Megestrol Acetate (MA)
Intervention descriptions: intervention 1: BN83495 will be administered as a 40 mg tablet once a day orally intervention 2: MA will be administered orally as 160mg daily

Protocol documents:
Clinical trial NCT00917501
Conditions: Mania
Keywords: Mania Adolescents at risk for Mania
Sponsor: University of Cincinnati
Start date: 2009-06-01; Completion date: 2013-07-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see if taking a substance called omega-3 fatty acids is effective, safe, and well-tolerated for treating adolescents with major depressive disorder (also called simply "depression" or "clinical depression"). Another purpose of this study is to see how much omega-3 fatty acids are in a patient's blood and if that makes the patient more or less likely to develop mania (i.e. periods of irritability or extreme silliness accompanied by decreased need for sleep, risky behaviors, feeling like the patient has special abilities, inability to sit still, and rapid speech) in the future. Yet another purpose of this study is to see how taking omega-3 fatty acids affect brain scans. Omega-3 fatty acids are not United States Food and Drug Administration (FDA)-approved to treat depression in adults or in children and adolescents.

Omega-3 fatty acids can only be obtained through diet, most often from fish and other sea foods, though they are also found in other food sources such as flax seed. Omega-3 fatty acids have been shown to play a role in affecting brain chemicals responsible for regulating mood and have been found to reduce symptoms of depression in medicated-patients with major depressive disorder.

By completing this study, the investigators hope to better understand who benefits from treatment, why they do or do not respond to medications, and who is at greater risk for developing further mental illness. With this information, the investigators hope to be able to improve treatment and outcome in people with major depressive disorder.

Detailed description:
A. Specific Aims: (1) To collect pilot data regarding the efficacy, safety, and tolerability of omega-3 fatty acid supplementation for the treatment of adolescents with active depressive symptoms and a high risk for developing mania (i.e. the patient has a bipolar parent and meet DSM-IV-TR criteria for major depressive disorder). (2) To use proton magnetic resonance spectroscopy (1H MRS) (i.e. prefrontal neurochemistry) and red blood cell (RBC) omega-3 fatty acid levels to examine potential mediators of treatment response to omega-3 fatty acids in adolescents with a high risk for mania.

Arms: arm 1: Placebo to the Omega-3 given in other group taken twice a day. arm 2: Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA \& will be taken twice a day.
Interventions: intervention 1: OMega 3 intervention 2: Placebo
Intervention descriptions: intervention 1: Individual omega-3 capsules contain 400 mg EPA and 200 mg DHA taken twice a day intervention 2: Placebo given twice a day which will be compared to Omega 3

Protocol documents:
Clinical trial NCT00928174
Conditions: Prostate Cancer
Keywords: Androgen insensitive prostate cancer
Sponsor: Queen's Medical Center
Start date: 2009-06-01; Completion date: 2013-07-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether positron emission tomography / computed tomography (PET/CT) using fluorine-18 fluorocholine as an imaging agent can characterize regional responses to anti-androgen therapies in a manner that in the future aid in the customized planning of treatments for patients with androgen-insensitive prostate cancer.

Detailed description:

Arms: arm 1: Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.
Interventions: intervention 1: IV administration of fluorine-18 fluorocholine followed by PET/CT imaging
Intervention descriptions: intervention 1: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy.

Protocol documents:
Clinical trial NCT00931944
Conditions: Amyotrophic Lateral Sclerosis
Keywords: ALS Amyotrophic Lateral Sclerosis Lou Gehrig Lou Gehrig's Lou Gehrig's disease Motor Neuron Disease Nervous System Diseases KNS-760704 RTPB
Sponsor: Knopp Biosciences
Start date: 2009-07-01; Completion date: 2013-07-01
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center study designed to extend the evaluation of the safety, tolerability, and clinical effects of oral administration of KNS-760704 in patients with ALS.

Detailed description:
Patients who complete the Part 2 Week 28 visit in study KNS-760704-CL201 and patients with ALS who were actively receiving RTPB \[(6R)-4,5,6,7-tetrahydro-N6-propyl-2,6-benzothiazolediamine dihydro-chloride monohydrate\] under Research IND #60,948 were eligible to participate in this study.

Eligible patients received 1 tablet of KNS-760704 (150 mg) every 12 hours (Q12H) (300 mg total daily dose) for up to 180 weeks.

Arms: arm 1: Open-label KNS-760704 (150 mg Q12H)
Interventions: intervention 1: KNS-760704
Intervention descriptions: intervention 1: 150 mg Q12H KNS-760704 given orally (300 mg total daily dose)

Protocol documents:
Clinical trial NCT00937560
Conditions: Ovarian Cancer
Sponsor: Hoffmann-La Roche
Start date: 2009-06-25; Completion date: 2013-07-01
Enrollment: 190 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study evaluated the efficacy and safety of first-line chemotherapy with carboplatin and dose-dense weekly paclitaxel plus bevacizumab (Avastin) in participants with epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants received 6-8 3-week cycles of treatment with bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve (AUC) of 6 on day 1 of each cycle. Following combination chemotherapy, bevacizumab could be continued to be given as a monotherapy.

Detailed description:

Arms: arm 1: Participants received 6-8 (at the investigator's discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m\^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = \[glomerular filtration rate + 25\] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
Interventions: intervention 1: Bevacizumab intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: Bevacizumab was supplied as a sterile solution for infusion. intervention 2: Paclitaxel was supplied locally in commercial batches. intervention 3: Carboplatin was supplied locally in commercial batches.

Protocol documents:
Clinical trial NCT01000480
Conditions: Non Small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2009-10-01; Completion date: 2013-07-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial investigates pemetrexed and cisplatin followed by pemetrexed and cisplatin in combination with radiotherapy in participants with locally advanced, non-small cell lung cancer (NSCLC). The purpose of the study is to assess the antitumor activity as measured by progression free survival 1 year after start of treatment with study drug.

Detailed description:
The participants will receive 2 cycles of pemetrexed and cisplatin. If the participants achieve complete response, partial response or stable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, have ≤35% of the total calculated lung volume receive more than 20 Gy (V20) according to the 3-dimensional (3-D) radiotherapy planning Dose Volume Histograms, have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, have no residual neurological toxicity \> Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE), they will receive 2 additional cycles of pemetrexed and cisplatin, combined with radiotherapy. The combination of radiotherapy will begin 22 to 36 days after completion of the second infusion of induction therapy with pemetrexed-cisplatin.

Arms: arm 1: Pemetrexed and cisplatin are given as induction therapy followed after by pemetrexed and cisplatin with concurrent radiotherapy.
Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Thoracic Radiotherapy
Intervention descriptions: intervention 1: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of a 21 day cycle for 2 cycles: with possibility of 2 additional cycles. intervention 2: 75 mg/m² intravenous infusion on Day 1 of a 21 day cycle for 2 cycles; with the possibility of 2 additional cycles. intervention 3: Administered at 2 gray (Gy)/fraction after completion of the pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and will continue daily (5 days per week) until the total delivered dose reaches a therapeutic goal of 66 Gy, over approximately 7 weeks.

Protocol documents:
Clinical trial NCT01006707
Conditions: Substance-Related Disorders
Sponsor: Stanford University
Start date: 2010-11-01; Completion date: 2013-07-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Opioid medications are commonly used for pain relief. When given over time, physical dependence can occur. This results in unpleasant side effects--such as agitation and nausea--if opioid medications are suddenly stopped. However, we do not know how withdrawal affects the brain. We know that a medication named Ondansetron can help ease or prevent symptoms associated with opioid withdrawal. Through imaging of the brain by fMRI, we hope to see how opioid withdrawal, with and without the administration of ondansetron, affects brain activity.

Detailed description:
During the study, each participant attended three separate lab-based acute opioid withdrawal sessions. The first session was undertaken in a mock MRI scanner and was designed to determine if participants could tolerate withdrawal in the scanning environment. Participants who were able to successfully and safely tolerate opioid withdrawal while in the scanner were approved to continue with the following study sessions. Participants were then pretreated intravenously (IV) with either 0.9% normal saline placebo or 8mg ondansetron. Later, participants in all sessions received IV naloxone (10mg/70kg) to precipitate opioid withdrawal. Participants were assigned to ondansetron or placebo pretreatment conditions in a randomized, double-blinded, and counter-balanced order. Objective Opioid Withdrawal Scale (OOWS) and Subjective Opioid Withdrawal Scale (SOWS) were assessed throughout the study to quantify withdrawal. Study timeline progressed as follows: T=-165, 8mg ondansetron or placebo infusion, T=-135, Morphine infusion (10mg/70kg), T=-41 preparation for MRI, T=-21, start MRI, T=-13, baseline OOWS/SOWS, T=-9, start of fMRI, T=0 Naloxone induced withdrawal, T=5, OOWS, T=15, OOWS, T=20, Retrospective OOWS.

Arms: arm 1: Some participants received ondansetron pretreatment during the second session, and then placebo during the third session. arm 2: Some participants received placebo pretreatment during the second session, and then ondansetron pretreatment during the third session.
Interventions: intervention 1: Ondansetron
Intervention descriptions: intervention 1: In this cross-over study, the blinded patient will receive saline placebo in one session and ondansetron in the other. The order is decided with a randomization table. If ondansetron is randomly chosen, an 8mg IV Bolus will be given at the start of the study for 30 minutes by the unblinded investigator.

Protocol documents:
Clinical trial NCT01038921
Conditions: Metabolic Syndrome
Keywords: Blood Pressure Glucose levels HDL levels Triglyceride levels Waist Circumference
Sponsor: Emory University
Start date: 2009-07-01; Completion date: 2013-07-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This trial seeks to compare the effects of melatonin supplementation versus placebo in subjects with the metabolic syndrome.

Detailed description:
The primary purpose of this Phase II crossover design trial is to examine the safety and efficacy of 8mg of melatonin taken one hour before bedtime compared to a placebo treatment to improve at least one of the five components associated with the metabolic syndrome.

Arms: arm 1: Melatonin 8mg one hour before bedtime for 10 weeks arm 2: Placebo administered 1 hour before bedtime for 10 weeks
Interventions: intervention 1: Melatonin intervention 2: Placebo
Intervention descriptions: intervention 1: 8 mg dose of Melatonin intervention 2: Placebo

Protocol documents:
Clinical trial NCT01071993
Conditions: Nephropathy
Keywords: prevention nephropathy
Sponsor: University of Oklahoma
Start date: 2010-03-01; Completion date: 2013-07-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Detailed description:
Due to the conflict in the available data, there are no practice guidelines that are established in order to prevent contrast-induced nephropathy (CIN). Our goal is to determine if statin therapy plus intravenous normal saline, in patients with chronic renal insufficiency undergoing angiography, is superior to placebo plus intravenous normal saline therapy in the prevention of CIN.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: atorvastatin
Intervention descriptions: intervention 1: pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure) intervention 2: pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)

Protocol documents:
Clinical trial NCT01097460
Conditions: Breast Neoplasms
Keywords: HER2/HER3 Bispecific Antibody Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer HER2 Positive Breast Cancer Trastuzumab Herceptin
Sponsor: Merrimack Pharmaceuticals
Start date: 2010-04-01; Completion date: 2013-07-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.

Detailed description:
Phase 1: Safety and tolerability of the MM-111 + Herceptin combination will be evaluated and the recommended Phase 2 dose will be determined.

Arms: arm 1: MM-111 will be combined with Herceptin
Interventions: intervention 1: MM-111 + Herceptin
Intervention descriptions: intervention 1: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV

Protocol documents:
Clinical trial NCT01180647
Conditions: Opiate Dependence
Keywords: Extended-release naltrexone Prisoners Opioid addiction prevention Medication Treatment Alternatives Prevention of Relapse to Opioid Addiction
Sponsor: NYU Langone Health
Start date: 2010-05-01; Completion date: 2013-07-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot study's primary aim is to compare rates of sustained opioid relapse, defined as self-reported opioid use \>50% (\>15 of 30) of days during the first 30 days following release from jail, among persons treated with XR-NTX pre-release vs. controls not receiving XR-NTX.

Detailed description:
This protocol randomizes persons soon-to-be-released from a large urban jail to treatment with extended-release naltrexone (XR-NTX), a full opioid antagonist that prevents the activity of heroin and other opioids. Investigators at NYUSOM and NYC DOHMH will recruit heroin dependent persons from NYC jails who are soon-to-be-released, not accessing opioid agonist pharmacotherapy, with lowered tolerance due to incarceration, and extremely likely to relapse and risk accidental overdose at release. All N=40 participants receive a two-session, individual psychosocial intervention, Motivational Interviewing. Half (n=20) will be randomized to pre-release treatment with XR-NTX. Immediately and one month following release, participants will be offered continued psychosocial and medication-assisted treatment (naltrexone, buprenorphine, or methadone) at Bellevue Hospital, including a second XR-NTX dose among XR-NTX arm participants. The primary outcome is relapse to sustained opioid use during the first 30 days post-release. We hypothesize an XR-NTX arm will report significantly lower rates of sustained opioid relapse following release.

Arms: arm 1: A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection. arm 2: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
Interventions: intervention 1: Extended-Release Naltrexone intervention 2: Motivational Enhancement Counseling
Intervention descriptions: intervention 1: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly). intervention 2: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.

Protocol documents: