ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00600106
Conditions: Myocardial Ischemia
Sponsor: Cedars-Sinai Medical Center
Start date: 1999-12-01; Completion date: 2010-03-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the main trial was to evaluate the effect of low dose hormone replacement therapy with 1 mg norethindrone/10mcg ethinyl estradiol in postmenopausal women with a history of chest discomfort, myocardial ischemia and no obstructive CAD. For the purposes of this study as a core lab coordinating center, the investigators will be performing P31 MRS core lab analyses; hormone core lab analyses; lipid core lab analyses; glucose, insulin and HOMA core lab analyses; exercise stress test/Holter monitor core lab analyses; brachial artery reactivity test core lab analyses; full study data analyses for manuscript preparation and the writing and submission and publication of manuscript.

The main trial duration: December 1999 - May 2003.

The ancillary data analysis project duration: April 2006 - March 2010.

Detailed description:
See Brief Summary above.

Arms: arm 1: Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE) arm 2: 1mg placebo
Interventions: intervention 1: 1/10 NA/EE intervention 2: Placebo
Intervention descriptions: intervention 1: Hormone replacement therapy with 1 mg norethindrone/10 mcg thinyl estradiol (1/10 NA/EE) intervention 2: 1 mg placebo

Protocol documents:
Clinical trial NCT00614874
Conditions: Asthma
Keywords: Asthma Avandia
Sponsor: Creighton University
Start date: 2008-12-01; Completion date: 2010-03-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Asthma is a common chronic disease characterized by airway inflammation and bronchoconstriction. This study utilizes the drug rosiglitazone (Avandia)to treat the effects of airway inflammation in patients with asthma.

The study will be conducted on 14 adult steroid naive patients with asthma. Patients with qualifying pulmonary function testing values will be eligible for enrollment. Enrolled subjects will be treated with rosiglitazone orally at 2mg dose for 4 weeks. Patients will be reassessed and dosing will increase in 4 week increments up to 8mg.

Detailed description:
The current standard-of-care utilizes corticosteroids to down-regulate the inflammatory state in patients with asthma. However, corticosteroids have many side effects and are not universally effective. New safe anti-inflammatory agents are needed to help modulate the disease. Peroxisome proliferator-activated receptor agonists are widely used to manage diabetes mellitus, another common chronic disease. These agents have been study models and have been shown to have anti-inflammatory effects in lung tissue. Case reports have noted improvement in asthma symptoms in patients being treated with these agents. These agents are ideally placed for human research given their long record of safe use in the treatment of type 2 diabetes.

Arms: arm 1: Subjects took rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
Interventions: intervention 1: rosiglitazone
Intervention descriptions: intervention 1: 2mg, 4mg, 8mg

Protocol documents:
Clinical trial NCT00614939
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors HbA1c incretins Renal Impairment
Sponsor: AstraZeneca
Start date: 2008-01-01; Completion date: 2010-03-01
Enrollment: 572 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally impaired patients.

Detailed description:

Arms: arm 1: Saxagliptin arm 2: Placebo to match
Interventions: intervention 1: Saxagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5 mg once daily oral dose intervention 2: Placebo

Protocol documents:
Clinical trial NCT00616434
Conditions: Active Ulcerative Colitis
Sponsor: Biogen
Start date: 2008-05-01; Completion date: 2010-03-01
Enrollment: 123 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to evaluate the clinical activity of interferon beta-1a in participants with moderate to severe ulcerative colitis (UC). Secondary objectives of this study are to determine (i) the safety and tolerability of interferon beta-1a in participants with moderate to severe UC, and (ii) the percentage of participants, with a decrease in the Simple Clinical Colitis Activity Index (SCCAI) score of ≥3 points at Week 8.

Detailed description:

Arms: arm 1: Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks arm 2: Placebo IM injection twice weekly for 12 weeks
Interventions: intervention 1: BG9418 (Interferon beta-1a) intervention 2: Placebo
Intervention descriptions: intervention 1: Avonex IM injection, self-administered per protocol intervention 2: Placebo IM injection, self-administered per protocol.

Protocol documents:
Clinical trial NCT00619489
Conditions: Ulcerative Colitis Crohn's Disease
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2007-12-01; Completion date: 2010-03-01
Enrollment: 72 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.

Detailed description:
This was a phase 2, multiple-dose, open-label study of vedolizumab administered intravenously (IV) every 8 weeks. The study population included treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants, as well as 38 UC participants who had tolerated vedolizumab well during Study C13002 (NCT01177228).

In the original study protocol, all participants were randomized to receive vedolizumab at doses of either 6 mg/kg or 10 mg/kg. With the implementation of Amendment 1, the assigned doses of vedolizumab were decreased to 2.0 mg/kg and 6.0 mg/kg. To implement the dose changes, instead of randomizing all participants across both doses, those who rolled over from Study C13002 were reassigned to receive the 2.0 mg/kg dose and all participants who entered C13004 naïve to treatment were to receive the 6.0 mg/kg dose, starting on the next scheduled dosing day. Also, if participants assigned to the 2 mg/kg dose experienced flare, they were to receive the higher 6 mg/kg dose.

In the results analyses for this study, participants are grouped according to the lowest dose received, i.e., 2.0 mg/kg or 6.0 mg/kg vedolizumab.

Arms: arm 1: Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks. arm 2: Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks.
Interventions: intervention 1: vedolizumab
Intervention descriptions: intervention 1: Vedolizumab for intravenous (IV) infusion

Protocol documents:
Clinical trial NCT00621842
Conditions: Bipolar Disorder Depression, Bipolar
Keywords: Geriatric Psychiatry Aged lamotrigine
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2008-01-01; Completion date: 2010-03-01
Enrollment: 57 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Lamotrigine regular tablet formulation intervention 2: Lamotrigine novel formulation
Intervention descriptions: intervention 1: Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds. intervention 2: Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used.

Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.

Protocol documents:
Clinical trial NCT00623597
Conditions: HIV Infections
Sponsor: Hoffmann-La Roche
Start date: 2008-06-01; Completion date: 2010-03-01
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the pharmacokinetics, safety and activity of saquinavir (Invirase hard gel capsules, film coated tablets or opened capsules) boosted by combination with ritonavir, in HIV-1 infected infants and children between the ages of 4 months and 6 years. Patients will commence treatment with saquinavir 50mg/kg bid plus ritonavir 2.5mg/kg or 3.0mg/kg (dependent on body weight), and a background antiretroviral regimen. If drug exposures are found to be dissimilar to those previously seen in older children and adults, or are associated with toxicities, subsequent dose adjustments will be made. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ritonavir intervention 2: saquinavir [Invirase]
Intervention descriptions: intervention 1: 2.5-3.0mg/kg po bid (starting dose) for 48 weeks intervention 2: 50mg/kg po bid (starting dose) for 48 weeks

Protocol documents:
Clinical trial NCT00631410
Conditions: Colorectal Neoplasms
Keywords: Phase 1 CRC SU011248 Sunitinib FOLFOX Colorectal cancer metastatic carcinoma of the colon or rectum
Sponsor: Pfizer
Start date: 2008-01-01; Completion date: 2010-03-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: sunitinib + mFOLFOX6 intervention 2: sunitinib + mFOLFOX6
Intervention descriptions: intervention 1: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2) intervention 2: 50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)

Protocol documents:
Clinical trial NCT00631449
Conditions: HIV Infections
Keywords: HIV Treatment intensification Low level viremia Suboptimal CD4+ T cell response treatment experienced
Sponsor: University of California, San Francisco
Start date: 2008-02-01; Completion date: 2010-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether treatment with Raltegravir further decreases HIV viral replication in HAART-suppressed, HIV-infected patients, potentially improving immune response to antiretroviral therapy.

Detailed description:

Arms: arm 1: For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines. arm 2: For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.
Interventions: intervention 1: Raltegravir intervention 2: Placebo
Intervention descriptions: intervention 1: For subjects assigned to the raltegravir group, subjects will receive raltegravir 400 mg to be taken by mouth twice daily, in addition to continuing to take their current anti-HIV medicines. intervention 2: For subjects assigned to the placebo group, subjects will receive a matching placebo pill 400 mg to be taken by mouth twice daily for 24 weeks, in addition to continuing to take their current anti-HIV medicines.

Protocol documents:
Clinical trial NCT00632736
Conditions: Parkinson Disease Parkinson's Disease
Keywords: ropinirole XL REQUIP Parkinson's disease long term safety efficacy safety ropinirole CR ropinirole IR open-label
Sponsor: GlaxoSmithKline
Start date: 2004-02-01; Completion date: 2010-03-01
Enrollment: 419 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the safety profile of ropinirole XL during long-term treatment in subjects with early and advanced Parkinson's disease

Detailed description:

Arms: arm 1: Ropinirole XL (formerly CR)
Interventions: intervention 1: Ropinirole XL (formerly CR)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00640393
Conditions: Psoriasis Vulgaris
Keywords: Etanercept, UVB, Enbrel, Psoriasis.
Sponsor: Innovaderm Research Inc.
Start date: 2008-04-01; Completion date: 2010-03-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will provide data on the addition of narrow band ultra violet B (nbUVB) phototherapy to participants who have not shown an excellent response to three months of etanercept.

Detailed description:
All participants will receive etanercept 50 mg twice a week for 12 weeks. Participants who reach PASI-90 at Day 84 will be discontinued from the study (they can continue receiving commercial etanercept outside the study). Participants remaining in the study at Day 84 will decrease etanercept to 50 mg weekly for another 12 weeks.

Participants who do not attain a 90 percent reduction in PASI from baseline (PASI-90) after 12 weeks will be randomized (1:1) to receive either etanercept alone or etanercept with short courses of narrow band ultra violet B (nbUVB)phototherapy. Participants randomized to the nbUVB group will receive nbUVB treatments three times a weeks for at least four weeks. At every planned study visit after Day 84, nbUVB treatment will be discontinued in participants who reach PASI-90. nbUVB phototherapy will be re-initiated for another four weeks at the subsequent planned study visit if they lose their PASI-90 response.

Efficacy will be evaluated with PASI, BSA and PGA by a blinded evaluator at Days 0, 28, 84, 112, 140 and 168. The effect of the treatment on quality of life will be evaluated using the DLQI questionnaire at Days 112, 140 and 168. Safety will be evaluated by physical examination and adverse events evaluation.

Arms: arm 1: All participants received etanercept 50 mg twice a week for 12 weeks. arm 2: Participants who did not reach a 90 percent reduction in psoriasis area and severity index (PASI-90) after 12 weeks and were randomized to the narrow band ultra violet B (nbUVB) group. They received nbUVB treatments three times a week and 50 mg Etanercept once per week. arm 3: Participants who did not reach PASI-90 after 12 weeks and were randomized to the Etanercept group. They received 50 mg Etanercept once per a week.
Interventions: intervention 1: Etanercept intervention 2: nbUVB
Intervention descriptions: intervention 1: Etanercept 50 mg, subcutaneous (SC) injection. intervention 2: None

Protocol documents:
Clinical trial NCT00641719
Conditions: Diabetic Neuropathies
Sponsor: Eli Lilly and Company
Start date: 2008-03-01; Completion date: 2010-03-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.

Detailed description:

Arms: arm 1: Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year arm 2: Duloxetine 60 mg QD, PO, 1 year
Interventions: intervention 1: Duloxetine hydrochloride intervention 2: Duloxetine hydrochloride
Intervention descriptions: intervention 1: Duloxetine 40 mg QD, PO, 1 year intervention 2: Duloxetine 60 mg QD, PO, 1 year

Protocol documents:
Clinical trial NCT00651820
Conditions: Scarring Impaired Wound Healing
Keywords: wound healing scarring collagenase Santyl
Sponsor: Healthpoint
Start date: 2008-04-01; Completion date: 2010-03-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare the rate of complete wound closure and quality of resulting scar at 3, 6 and 9 months, between dermatome-induced skin wounds treated with Collagenase Santyl Ointment versus vehicle alone.

Detailed description:

Arms: arm 1: Dermatome-induced skin wounds treated with drug active (collagenase). arm 2: Dermatome-induced skin wounds treated with Vehicle alone.
Interventions: intervention 1: Collagenase Santyl intervention 2: Collagenase Santyl Vehicle
Intervention descriptions: intervention 1: Dermatome-induced skin wounds treated with drug active.

Each subject serves as his own control receiving both treatments in parallel. intervention 2: Dermatome-induced skin wounds treated with Vehicle alone. Each subject serves as his own control receiving both treatments in parallel.

Protocol documents:
Clinical trial NCT00659737
Conditions: Nausea Vomiting
Keywords: Post-operative Nausea and Vomiting (PONV)
Sponsor: Drexel University College of Medicine
Start date: 2008-04-01; Completion date: 2010-03-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Detailed description:
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU). Additional use of resources costs the health care industry hundreds of millions of dollars annually. Patient satisfaction is greatly improved when PONV is prevented.4 PONV etiology is multifactorial and the treatment is multimodal.

Arms: arm 1: Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.

Emend (Aprepitant) + Placebo arm 2: Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
Interventions: intervention 1: Aprepitant intervention 2: Scopolamine
Intervention descriptions: intervention 1: 40mg tablet intervention 2: 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days

Protocol documents:
Clinical trial NCT00667277
Conditions: Myelofibrosis
Keywords: Myelofibrosis Idiopathic Bevacizumab Avastin bone marrow fibrosis bone marrow angiogenesis JAK2
Sponsor: Ronald Hoffman
Start date: 2008-03-01; Completion date: 2010-03-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Myelofibrosis is the gradual replacement of bone marrow (place where most new blood cells are produced) by fibrous tissue which reduces the body's ability to produce new blood cells and results in the development of chronic anemia (low red blood cell count). One of the main distinctions of myelofibrosis is "extramedullary hematopoiesis", the migration or traveling of the blood-forming cells out of the bones to other parts of the body, such as the liver or spleen, resulting in an enlarged spleen and liver.

There is not a standard treatment for myelofibrosis, therefore there is no medication that is specifically used in the treatment of myelofibrosis. Bevacizumab (Avastin®) targets and stops a growth factor in the body that helps produce the type of fibrous tissue that is gradually replacing the bone marrow in the bones.

The purpose of this study is to find out how safe and effective bevacizumab is in treating myelofibrosis. The investigators also wish to find out important biologic characteristics or features of myelofibrosis (how it works and operates) during the time of study participation through an additional correlative biomarker study (MPD-RC #107). The purpose of the biomarker study is to understand the causes of MPD and to develop improved methods for the diagnosis and treatment of these diseases, while the main study is trying to find out how well bevacizumab will work in treating the disease.

Detailed description:

Arms: arm 1: Use of bevacizumab (Avastin) in the treatment of myelofibrosis.
Interventions: intervention 1: bevacizumab (Avastin)
Intervention descriptions: intervention 1: 15 mg/kg of bevacizumab by IV infusion once every 3 weeks (1 cycle) for 12 weeks (4 cycles)

Protocol documents:
Clinical trial NCT00682734
Conditions: Migraine
Sponsor: Montefiore Medical Center
Start date: 2008-04-01; Completion date: 2010-03-01
Enrollment: 349 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Metoclopramide is an effective intravenous treatment for acute migraine attacks, but we do not know the best dose to administer. This study compares three different doses of metoclorpamide.

Detailed description:
Patients with acute migraine attacks are eligible for enrollment if they present to the emergency department of Montefiore Medical Center. Pain scores are assessed at baseline and every 30 minutes for two hours, and then again by telephone 48 hours after discharge

Arms: arm 1: Metoclopramide 10 mg+ diphenhydramine 25 mg. This medication was administered as an intravenous drip over 20 minutes arm 2: metoclopramide 20 mg + diphenhydramine 25 mg. Administered as an intravenous drip over 20 minutes. arm 3: metoclopramide 40 mg + diphenhdyramine 25mg. Administered as an intravenous drip over 20 minutes.
Interventions: intervention 1: metoclopramide intervention 2: metoclopramide intervention 3: metoclopramide intervention 4: Diphenhydramine 25mg
Intervention descriptions: intervention 1: metoclopramide 20 mg intervention 2: metoclopramide 40 mg intervention 3: metoclopramide 10 mg intervention 4: Diphenhydramine 25mg, administered as an intravenous drip over 20 minutes

Protocol documents: