ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01267825
Conditions: Disc Herniation Lumbosacral Radiculopathy
Keywords: Disc herniation Lumbosacral radiculopathy Corticosteroids
Sponsor: Montefiore Medical Center
Start date: 2010-09-01; Completion date: 2013-08-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Herniated disc sometimes cause back pain radiating down to a leg. This pain can be so severe that it is functionally disabling. The purpose of this randomized clinical trial is to determine if corticosteroid medication, delivered directly to the area near the herniated disc, can improve the pain and functional disability associated with a herniated disc.

Detailed description:

Arms: arm 1: CT guided perineural injection of corticosteroid+ bupivicaine Also get typical medical care arm 2: None
Interventions: intervention 1: CT-guided corticosteroid+ bupivicaine intervention 2: Standard medical care
Intervention descriptions: intervention 1: CT-guided corticosteroid+ bupivicaine Also get standard medical care intervention 2: Naproxen + Oxycodone/ Acetaminophen

Protocol documents:
Clinical trial NCT01268150
Conditions: Locally Recurrent Metastatic Breast Cancer ( HER2 Negative)
Sponsor: Eisai Inc.
Start date: 2011-02-01; Completion date: 2013-08-01
Enrollment: 56 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic breast cancer.

Detailed description:
This is a multicenter, single-arm, Phase 2 trial to assess the efficacy and safety of single-agent eribulin mesylate for first-line treatment of subjects with locally recurrent or metastatic human epidermal growth factor receptor (HER2)-negative breast cancer. A total of 52 adult female subjects will be enrolled and treated with eribulin mesylate (1.4 mg/m2 as an intravenous \[i.v.\] infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle).

Arms: arm 1: None
Interventions: intervention 1: Eribulin mesylate
Intervention descriptions: intervention 1: Eribulin mesylate 1.4 mg/m2 will be administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.

Protocol documents:
Clinical trial NCT01279447
Conditions: Internal Derangement of Knee
Keywords: infrapatellar nerve saphenous nerve knee arthroscopy nerve block
Sponsor: Northwestern University
Start date: 2011-01-01; Completion date: 2013-08-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy.

Detailed description:
The purpose of this study is to determine whether infrapatellar branch of the saphenous nerve blocks are effective in decreasing analgesic use, promoting earlier mobility, and improving long term outcome scores after knee arthroscopy. Randomized, double-blinded, placebo controlled, study.

Arms: arm 1: A sham infrapatellar block performed under US guidance with normal saline arm 2: An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine
Interventions: intervention 1: 0.25% Bupivacaine intervention 2: Normal Saline
Intervention descriptions: intervention 1: 10cc, single dose, US guided injection intervention 2: 10cc, single dose, US guided injection

Protocol documents:
Clinical trial NCT01290315
Conditions: Iron Deficiency Anemia
Sponsor: American Regent, Inc.
Start date: 2009-08-01; Completion date: 2013-08-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects.

Detailed description:
This was a Phase 2a, open-label, multicenter, randomized study that compared the safety and oxidative stress potential of FCM vs. IV iron sucrose or IV iron dextran in female subjects with IDA. Subjects with a diagnosis of IDA who required iron supplementation met all inclusion and no exclusion criteria, and had given informed consent were randomized. The duration of the study for each subject was a maximum of 6 weeks.

Eligible subjects were randomized in a 1:1 ratio to FCM (Group A) or IV iron sucrose or IV iron dextran (Group B).

Group A subjects received a single undiluted dose of iron as FCM by a slow IV injection on Day 0. Cohort I received 500 mg and Cohort II received 750 mg. Group B subjects received a single dose of iron as IV iron sucrose or as IC iron dextran on Day 0. Cohort I receive 500 mg iron sucrose and Cohort II received 750 mg iron dextran. Iron dextran administration was preceded by a 25 mg test dose 1 hour prior to infusion.

All subjects had laboratory assessments at Baseline, 2 hours post-infusion, 24 hours post-infusion, Day 7 (drawn at the same time of day \[within 4 hours\] as the 24-hour visit), and Day 30 (drawn at the same time of day \[within 4 hours\] as the the 24-hour visit). On Days 7 and 30, the safety evalutation for all subjects included treatment-emergent adverse event reporting, concomitant medication review, physical examination including vital signs, and laboratory assessments. Any subject who withdrew from the study received a follow-up phone call 30 days after they received study drug.

Arms: arm 1: Intravenous iron arm 2: Intravenous iron
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Iron Sucrose / Iron Dextran
Intervention descriptions: intervention 1: One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II) intervention 2: One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Protocol documents:
Clinical trial NCT01307007
Conditions: Iron Deficiency Anemia
Sponsor: American Regent, Inc.
Start date: 2010-09-01; Completion date: 2013-08-01
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Detailed description:
To assess the safety of an investigational intravenous iron (ferric carboxymaltose \[FCM\]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

Arms: arm 1: 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0 arm 2: Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
Interventions: intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Iron Dextran Injection
Intervention descriptions: intervention 1: 15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0 intervention 2: Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.

Protocol documents:
Clinical trial NCT01317797
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis MT203 Human IgG1 monoclonal antibody GM-CSF monoclonal antibody
Sponsor: Takeda
Start date: 2011-03-01; Completion date: 2013-08-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is primarily to investigate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis. Furthermore, the amount of MT203 in the blood will be measured and it will be investigated how the body responds to MT203 treatment and if MT203 is effective in the treatment of rheumatoid arthritis.

Detailed description:
The trial medication will be administered at 2 dose levels as subcutaneous injections. Each patient will receive three injections in total. The trial duration consists of a screening period (28 - 2 days prior to the first injection) and a treatment and observation period (4 months). The trial requires approximately 20 visits at the study site.

Arms: arm 1: Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. arm 2: Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. arm 3: Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Interventions: intervention 1: namilumab (MT203) intervention 2: Placebo
Intervention descriptions: intervention 1: administered three times, subcutaneous in the abdomen intervention 2: administered three times, subcutaneous in the abdomen

Protocol documents:
Clinical trial NCT01318694
Conditions: Hepatitis C
Keywords: Chronic hepatitis C Cyclophilin inhibitor
Sponsor: Debiopharm International SA
Start date: 2011-03-01; Completion date: 2013-08-01
Enrollment: 1081 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Detailed description:

Arms: arm 1: Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT):

* Participants with a viral load below the level of detection (\< LOD) at Week 4 stop study treatment after 24 weeks
* Participants with a viral load ≥ LOD at Week 4 complete 48 weeks of study treatment arm 2: Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT) arm 3: Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks arm 4: ALV Placebo with PEG and RBV for 48 weeks
Interventions: intervention 1: Alisporivir intervention 2: Peginterferon alfa-2a intervention 3: Ribavirin intervention 4: ALV Placebo
Intervention descriptions: intervention 1: ALV 200 mg soft gel capsules administered orally intervention 2: PEG 180 μg administered via subcutaneous (s.c.) injection once weekly intervention 3: RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose intervention 4: ALV placebo soft gel capsules administered orally

Protocol documents:
Clinical trial NCT01334554
Conditions: Metabolic Syndrome Obesity
Keywords: African American Women Metabolic Syndrome Endothelial function Sildenafil citrate
Sponsor: Vanderbilt University Medical Center
Start date: 2011-04-01; Completion date: 2013-08-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obesity has a greater detrimental impact on the health of African American women than on any other racial or gender group. Nearly 80% of African American women are overweight or obese in the United States. Hypertension and insulin resistance are more prevalent among African American women as compared to men and Caucasians. These conditions put them at increased risk for the development of diabetes mellitus and cardiovascular disease.

Recent studies have reported that a substance named Nitric Oxide (NO)may have some beneficial effect on how the body handles blood sugar and blood pressure. Of interest,some studies have shown that African Americans have decreased function of NO in their blood vessels.

In this study proposal the investigators will test if increasing NO function with a PDE-5 inhibitor (sildenafil citrate) will improve pre-diabetes and the health of the inner layer of the blood vessels in obese African American women.

Detailed description:

Arms: arm 1: Sildenafil 20 mg three times a day arm 2: placebo
Interventions: intervention 1: Sildenafil intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg three times a day. intervention 2: No active drug

Protocol documents:
Clinical trial NCT01392677
Conditions: Type 2 Diabetes Mellitus High HbA1c Level Inadequate Glycaemic Control
Keywords: dapagliflozin diabetes hyperglycaemia
Sponsor: AstraZeneca
Start date: 2011-10-01; Completion date: 2013-08-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study intends to compare the efficacy and safety of dapagliflozin versus placebo in patients with type 2 diabetes who have inadequate glycaemic control on a background combination of metformin and sulfonylurea.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: dapagliflozin intervention 2: placebo
Intervention descriptions: intervention 1: 10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period intervention 2: matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period

Protocol documents:
Clinical trial NCT01408641
Conditions: Alcohol Dependence Alcoholism Alcohol Abuse Alcohol Use Disorder PTSD Posttraumatic Stress Disorder
Keywords: topiramate PTSD drinking alcohol
Sponsor: University of Maryland, Baltimore
Start date: 2012-09-01; Completion date: 2013-08-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Alcohol abuse and dependence (alcohol use disorders, AUDs) and posttraumatic stress disorder (PTSD) are both prevalent in Veterans. Treating AUDs in Veterans with PTSD may be more difficult than treating AUDs in the general population. The FDA-approved medication topiramate has been shown to improve drinking outcomes in people with AUDs. Topiramate has also improved symptoms in people with PTSD. This study is designed to investigate whether topiramate will improve drinking outcomes in Veterans with PTSD.

Detailed description:

Arms: arm 1: Topiramate arm will be titrated (dose will increase slowly) over 6 weeks to 400mg or highest tolerated dose. arm 2: Placebo arm will receive matching capsules without topiramate.
Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: Topiramate titrated over 6 weeks to 400mg or highest tolerated dose. intervention 2: Placebo capsules without topiramate

Protocol documents:
Clinical trial NCT01425528
Conditions: GTP Cyclohydrolase Deficiency
Sponsor: University of Utah
Start date: 2011-08-01; Completion date: 2013-08-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to identify the dose of Kuvan needed to normalize the levels of tetrahydrobiopterin (BH4) in patients with a Guanosine Triphosphate Cyclohydrolase (GTPCH) deficiency and to asses the potential impact of oral Kuvan on mood and function in individuals with GTPCH deficiency who may be experiencing symptoms of anxiety, depression, fatigue, trouble concentrating, or memory loss. This will be a phase one study. The investigators will monitor patients over a period of three to six months while on the medication. Medication levels will be monitored by measuring the BH4 levels in cerebral spinal fluid (CSF). Patients will undergo a baseline lumbar puncture and two follow-up lumbar punctures for this purpose. The investigators will also monitor emotional function and motor function.

Detailed description:

Arms: arm 1: This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid. This cohort will begin at a dose of 20mg/kg/day. arm 2: Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1, but will plan on starting at 30 mg/kg/day.
Interventions: intervention 1: Sapropterin
Intervention descriptions: intervention 1: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1.

Protocol documents:
Clinical trial NCT01436279
Conditions: Cervical Preparation
Sponsor: Boston University
Start date: 2011-07-01; Completion date: 2013-08-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study the investigators plan to compare mifepristone and misoprostol use to osmotic dilator use for cervical preparation for 15-18 week surgical abortion. Mifepristone would be given 24 hours prior to abortion, and misoprostol 400 mcg would be administered buccally 2 hours prior to abortion. Osmotic dilators are the method currently used in our institution, and are placed 24 hours prior to abortion. The primary outcome will be the length of the procedure. Secondary outcomes will include amount of dilation achieved, ease of procedure, participant's assessment of discomfort before mifepristone or dilators, discomfort during the abortion procedure, acceptability to participants, and acceptability to staff.

Detailed description:

Arms: arm 1: Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure arm 2: Placed 20-24 hours prior to procedure
Interventions: intervention 1: Mifepristone intervention 2: osmotic dilators
Intervention descriptions: intervention 1: 200 mg po 20-24 hours prior to the procedure intervention 2: osmotic dilators placed in the cervix 20-24 hours prior to the procedure

Protocol documents:
Clinical trial NCT01439945
Conditions: Breast Cancer Cancer Survivor Hot Flashes
Keywords: hot flashes cancer survivor breast cancer
Sponsor: Alliance for Clinical Trials in Oncology
Start date: 2011-09-01; Completion date: 2013-08-01
Enrollment: 289 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Magnesium oxide may help relieve hot flashes symptoms in women with a history of breast cancer.

PURPOSE: This randomized clinical trial studies how well a high-dose or a low-dose of magnesium oxide works compared to placebo in treating menopausal women with hot flashes and a history of breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Evaluate the efficacy of magnesium oxide on hot flashes in women with a history of breast cancer.

Secondary

* Evaluate the side-effect profile of magnesium oxide in this study population.
* Evaluate the effect of magnesium oxide on the secondary outcomes hot flash frequencies, hot flash severities, toxicities (including diarrhea), and hot flash-related daily interference on activities.
* Evaluate the effect of magnesium oxide on the change of magnesium level (for the first 150 patients).

OUTLINE: This is a multicenter study. Patients are stratified according to age (18-49 years vs ≥ 50 years), current tamoxifen and/or selective estrogen receptor modulator (yes vs no), current aromatase inhibitor (yes vs no), and daily frequency of hot flashes (4-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive a low-dose of magnesium oxide orally (PO) daily (QD).
* Arm II: Patients receive a high-dose of magnesium oxide PO QD.
* Arm III: Patients receive a low-dose of placebo PO QD.
* Arm IV: Patients receive a high-dose of placebo PO QD. In all arms, treatment continues for 8 weeks in the absence of unacceptable toxicity.

Some patients may continue or crossover to receive magnesium for 4 more weeks.

Patients complete the Hot Flash Diary daily for 9 weeks beginning 1 week before treatment. They also complete the Symptom Experience Questionnaire, the Profile of Mood States (POMS), and Hot Flash-Related Daily Interference Scale (HFRDIS) questionnaires periodically during study treatment.

Patients undergo blood sample collection at baseline and at the end of weeks 5 and 9 for serum magnesium level analysis.

Arms: arm 1: Patients receive a low-dose of magnesium oxide orally (PO) daily (QD). arm 2: Patients receive a high-dose of magnesium oxide PO QD. arm 3: Patients receive a low-dose of placebo PO QD. arm 4: Patients receive a high-dose of placebo PO QD.
Interventions: intervention 1: magnesium oxide intervention 2: placebo
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO

Protocol documents:
Clinical trial NCT01453569
Conditions: Alzheimer Disease Cognitive Impairment
Sponsor: Shanghai Greenvalley Pharmaceutical Co., Ltd.
Start date: 2011-10-01; Completion date: 2013-08-01
Enrollment: 255 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to determine whether sodium oligo-mannurarate capsule is effective and safe in the treatment of mild to moderate alzheimer' disease, and to determine the best therapeutic dose of sodium oligo-mannurarate capsule.

Detailed description:
Alzheimer's disease is known for placing a great burden on caregivers which includes social, psychological, physical or economic aspects. Research indicates that the disease is associated with plaques and tangles in the brain. Currently used treatments offer a small symptomatic benefit. No treatments to delay or halt the progression of the disease are, as of yet, available. The investigators suppose sodium oligo-mannurarate capsule to be effective to halt the progression of the disease.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Sodium oligo-mannurarate 600mg intervention 2: Sodium oligo-mannurarate 900mg intervention 3: Placebo
Intervention descriptions: intervention 1: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks intervention 2: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks intervention 3: simulant of sodium oligo-mannurarate capsule

Protocol documents:
Clinical trial NCT01466192
Conditions: Chronic Hepatitis C
Keywords: Genotype 2
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-05-01; Completion date: 2013-08-01
Enrollment: 108 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who relapsed after previous treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MP-424 (generic name:Telaprevir) intervention 2: Ribavirin intervention 3: Peginterferon alfa-2b
Intervention descriptions: intervention 1: 750mg q8h for 12 weeks intervention 2: 400 - 1000 mg/day based on body weight for 24 weeks intervention 3: 1.5mcg/kg/week for 24 weeks

Protocol documents: