ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00383162
Conditions: Migraine Disorders
Keywords: Combination Product naproxen sodium sumatriptan succinate short acting triptan migraine, acute Poor response
Sponsor: GlaxoSmithKline
Start date: 2006-11-01; Completion date: 2007-10-01
Enrollment: 173 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design). \[Study 1 of 2\]

Detailed description:
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discontinued use of short acting triptan(s) within the past year due to non-response or intolerance. Subjects will treat 2 separate migraine attacks during the mild phase of each attack; one attack will be treated with one tablet of the Combination Product (sumatriptan succinate and naproxen sodium) and the other attack with one tablet of placebo (crossover design); however, the order of these treatments will be randomized. A minimum 1-week washout period is required between study medication treatment of the first and second migraine attacks.

Each subject will have two visits: (1) a Screening visit at study entry and (2) a Final visit 4-10 days after the second (or last) attack. A telephone contact will also be required 1-3 days after the first attack, and then once per month until the Final visit.

The primary study objective is to assess efficacy as measured by sustained pain-free (SPF) relief of Combination Product compared to placebo in treating migraine subjects who have previously discontinued treatment with short acting triptans (rizatriptan, sumatriptan, almotriptan, zolmitriptan, and eletriptan).

Arms: arm 1: Combination product (sumatriptan and naproxen sodium) \[Attack 1\] followed by placebo \[Attack 2\] arm 2: Placebo \[Attack 1\] followed by Combination Product (sumatriptan and naproxen sodium) \[Attack 2\]
Interventions: intervention 1: Combination Product (sumatriptan succinate / naproxen sodium) intervention 2: Placebo
Intervention descriptions: intervention 1: Bilayer tablet containing 85mg sumatriptan (as 119mg sumatriptan succinate; fast disintegrating/rapid release formulation) active ingredient in one layer, and 500mg naproxen sodium active ingredient in the second layer. intervention 2: Matching placebo tablet.

Protocol documents:
Clinical trial NCT00385541
Conditions: Post Operative Pain
Keywords: pain morphine hydromorphone nausea vomiting pruritis
Sponsor: Columbia University
Start date: 2003-11-01; Completion date: 2007-10-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Both morphine and hydromorphone are pain medications commonly used after surgery. It is thought at the institution that hydromorphone causes less side effects but this has not been studied. The study proposes to treat the patients with either morphine or hydromorphone and determine how much nausea, vomiting, and itching they have with each drug

Detailed description:

Arms: arm 1: Patients receive morphine 1mg/dose PCA for postsurgical pain; max 10 mg/hr; lockout 6 minutes. arm 2: Patients receive hydromorphone 0.2mg/dose PCA for postsurgical pain; max 10mg/hr; lockout 6 minutes.
Interventions: intervention 1: Morphine PCA intervention 2: Hydromorphone PCA
Intervention descriptions: intervention 1: Morphine 1mg/mL, dose 1mL, lockout 6 minutes, max 10mL intervention 2: hydromorphone PCA 0.2mg/lml, dose 1ml, lockout 6min, max 10ml

Protocol documents:
Clinical trial NCT00385944
Conditions: Acute Coronary Syndrome
Sponsor: Eli Lilly and Company
Start date: 2007-03-01; Completion date: 2007-10-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel.

Detailed description:

Arms: arm 1: Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) prasugrel 10 mg and two placebo tablets, matched to clopidogrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of clopidogrel two 75 mg tablets and one placebo matched to prasugrel and 100 mg aspirin, all taken orally once a day for the next 14 days. arm 2: Open label lead-in one time dose of Clopidogrel 900 mg oral tablets (a single or cumulative dose) and 250 mg to 500 mg aspirin loading dose (LD), either orally or intravenously. Patients are then assigned to maintenance dose (MD) Clopidogrel two 75 mg and one placebo tablet, matched to prasugrel, and 100 mg aspirin, all taken orally once a day for 14 days. Patients cross-over to MD of prasugrel one 10 mg tablet and two placebo tablets matched to clopidogrel and 100 mg aspirin, all taken orally once a day for the next 14 days.
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Prasugrel 10-mg tablet taken orally as a daily maintenance dose for a 14-day treatment period. intervention 2: Clopidogrel two 75-mg tablets taken orally as a daily maintenance dose for a 14-day treatment period.

Protocol documents:
Clinical trial NCT00387010
Conditions: Pain Chronic Pain Breakthrough Pain
Sponsor: Cephalon
Start date: 2006-12-01; Completion date: 2007-10-01
Enrollment: 218 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the study is to evaluate the impact of treatment with fentanyl buccal tablets on the anxiety symptoms commonly associated with chronic pain in patients with breakthrough pain (BTP). Other purposes are to assess the management of BTP, to evaluate patient functioning, and to determine any influences on the successful dose achieved.

Detailed description:

Arms: arm 1: Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
Interventions: intervention 1: Fentanyl Buccal Tablets
Intervention descriptions: intervention 1: Fentanyl buccal tablets (FBT) placed in the buccal cavity above a rear molar until disintegrated, approximately 14-25 minutes.

Dose titration: Participants self-administered FBT, starting at 100, 200 or 400 mcg (depending on analgesic used pre-study) and titrated to 600 and 800 mcg as needed. For each breakthrough pain (BTP) episode, participants took a dose, and did not take further study drug if adequate pain relief was achieved. If pain was not controlled within 30 minutes, the same dose level was repeated. If pain relief was inadequate 30 minutes after the second dose, usual rescue medication was taken for that BTP episode. Doses were adjusted until pain relief was adequate and side effects were tolerated.

Open-label: Once the successful dose of FBT was identified (100, 200, 400, 600, or 800 mcg), participants were dispensed a 4-week supply at the successful dose. Participants were not to use FBT for more than 6 BTP episodes or take more than 8 FBT daily.

Protocol documents:
Clinical trial NCT00390364
Conditions: Colorectal Cancer
Keywords: adenocarcinoma of the colon adenocarcinoma of the rectum recurrent colon cancer stage III colon cancer stage IV colon cancer recurrent rectal cancer stage III rectal cancer stage IV rectal cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2006-10-01; Completion date: 2007-10-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with advanced or metastatic colorectal cancer that did not respond to previous therapy.

Detailed description:
OBJECTIVES:

* Determine response rate, time to tumor progression, and survival of patients with advanced or metastatic refractory colorectal cancer and mutations in the PI3K gene treated with everolimus.
* Determine the toxicity profile of this drug in these patients.
* Measure the signaling pathways activated in these patients.
* Determine the pharmacodynamic effects of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor biopsies and normal skin biopsies at baseline and after the first course of study treatment. Tumor tissue is examined for biological markers (e.g., epidermal growth factor receptor, ERK, Akt, p70s6k, p27, and Rb protein) by immunohistochemistry; apoptosis quantification by TUNEL assay; Ki-67 quantification and Ki-index; gene expression; and c-fos and p27 expression by reverse-transcriptase polymerase chain reaction.

PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.

Interventions: intervention 1: everolimus intervention 2: antiangiogenesis therapy intervention 3: biopsy intervention 4: diagnostic procedure intervention 5: gene expression analysis intervention 6: immunohistochemistry staining method intervention 7: laboratory biomarker analysis intervention 8: mutation analysis intervention 9: protein tyrosine kinase inhibitor therapy intervention 10: reverse transcriptase-polymerase chain reaction
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None intervention 7: None intervention 8: None intervention 9: None intervention 10: None

Protocol documents:
Clinical trial NCT00395733
Conditions: Vascular Diseases
Keywords: Gadovist Gadavist MRI Imaging vascular diseases Chinese
Sponsor: Bayer
Start date: 2006-10-01; Completion date: 2007-10-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of vascular diseases in patients of Chinese origin.

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: Period 1: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged; Period 2: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged arm 2: Period 1: Participant received Gadopentate 0.5 M (iv), at a dose of 0.4 mL/kg BW, up to 0.6 mL/kg BW if 3 FOVs to be imaged; Period 2: Participant received Gadobutrol 1.0 M (iv: intravenous injection), at a dose of 0.2 mL/kg BW, up to 0.3 mL/kg BW if 3 Fields of View (FOVs) to be imaged
Interventions: intervention 1: Gadobutrol (Gadavist, Gadovist, BAY86-4875) intervention 2: Gadopentate dimeglumine (Magnevist, BAY86-4882)
Intervention descriptions: intervention 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW) intervention 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)

Protocol documents:
Clinical trial NCT00430638
Conditions: Hypertension
Keywords: Hypertension Angiotensin Receptor Blocker Calcium Channel Blocker Angiotensin Converting Enzyme Inhibitor Hydrochlorothiazide Stage I and II Hypertension
Sponsor: Daiichi Sankyo
Start date: 2006-12-01; Completion date: 2007-10-01
Enrollment: 278 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Detailed description:
This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:

* First 3 weeks (wks), all participants - olmesartan medoxomil 20 mg or placebo
* Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg or placebo
* Next 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 12.5 mg or placebo
* Final 3 wks, participants whose blood pressure was not controlled - olmesartan medoxomil 40 mg/HCT 25 mg or placebo
* Subjects with a mean BP of \<120/80 mmHg at any visit were considered responders and were not titrated up to the next dose level. However, they remained in the study at their currently assigned dose of study medication.
* Subjects with a mean office SBP ≥120 mmHg or a mean office DBP ≥80 mmHg at any subsequent visit(s) were considered 'uncontrolled' and were titrated to the next dose level according to the titration scheme above.
* Subjects who reach the highest dose (ie, olmesartan medoxomil 40 mg/HCT 25 mg) remained on that dose until study exit at Visit 8, unless safety concerns caused discontinuation of treatment.

Arms: arm 1: Olmesartan medoxomil, plus hydrochlorothiazide, if necessary arm 2: Placebo tablets were taken once daily for 12 weeks
Interventions: intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary intervention 2: Placebo
Intervention descriptions: intervention 1: olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks intervention 2: Oral tablets administered for once daily for 12 weeks

Protocol documents:
Clinical trial NCT00440011
Conditions: Glaucoma Ocular Hypertension
Sponsor: Allergan
Start date: 2006-08-01; Completion date: 2007-10-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering, will be randomized to receive either bimatoprost 0.03% or travoprost 0.004% in place of latanoprost 0.005%

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bimatoprost 0.03% eye drops intervention 2: travoprost 0.004% eye drops
Intervention descriptions: intervention 1: bimatoprost 0.03% 1 drop nightly for 3 months intervention 2: travoprost 0.004% 1 drop nightly for 3 months

Protocol documents:
Clinical trial NCT00442559
Conditions: Asthma Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2005-01-01; Completion date: 2007-10-01
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Detailed description:

Arms: arm 1: Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. arm 2: Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
Interventions: intervention 1: montelukast sodium intervention 2: inhaled corticosteroid
Intervention descriptions: intervention 1: Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months intervention 2: Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

Protocol documents:
Clinical trial NCT00446654
Conditions: Age Related Macular Degeneration
Sponsor: Progen Pharmaceuticals
Start date: 2007-04-01; Completion date: 2007-10-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals.

Detailed description:
The purpose of this research study is to determine how safe and effective subconjunctival injections of CGC-11047 are in subjects with wet age related macular degeneration at two different dosing intervals. Half of the participants in the study will receive CGC-11047 every two weeks and half of the participants in the study will receive CGC-11047 every four weeks. If your doctor determines that you are eligible for the study based on his/her judgement and according to the entry requirements set by the sponsor of the research, you will be randomly assigned (by chance, like the flip of a coin), to receive CGC-11047 every two weeks or every four weeks. Whether you receive drug every two weeks or every four weeks, you will still need to come to the clinic approximately every two weeks for the first three months, and approximately four times after that until it has been at least 12 months since you received your first treatment of study drug.

Two studies (this one and another one) are occurring to test CGC-11047 in patients with wet age-related macular degeneration for the first time. However, this drug (CGC-11047) is being studied in cancer patients at doses much higher than will be given to any subjects in either of these studies. The cancer patients have tolerated the drug well with the exception of one cancer patient who had two reactions to the drug (pancreatitis and hypotension). However, this patient had advanced cancer (non-Hodgkin's lymphoma with a life expectancy of less than 3 months) and received 38X the dose to be administered in this AMD study. Aside from this one patient, there have not been any serious side effects related to the drug.

This study will involve about 100 subjects at about 15 different sites internationally.

The study will take place over 12 months and will include about 12 office visits to the study doctor.

Arms: arm 1: 16.5 mg CGC-11047 as a subconjunctival injection once every two weeks. arm 2: 16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
Interventions: intervention 1: CGC-11047
Intervention descriptions: intervention 1: 16.5 mg (3.3%) subconjunctival injection

Protocol documents:
Clinical trial NCT00493311
Conditions: Fever
Sponsor: Mallinckrodt
Start date: 2007-06-01; Completion date: 2007-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given through a needle into a vein in your arm) is safe and effective in controlling fever when compared to placebo. Acetaminophen given this way is the investigational part of this study.

Detailed description:
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen (IVAPAP) Versus Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

Arms: arm 1: 1 g of acetaminophen in 100 mL of intravenous solution arm 2: 100 mL of intravenous placebo solution
Interventions: intervention 1: IV Placebo intervention 2: IV Acetaminophen intervention 3: Reference Standard Endotoxin (RSE)
Intervention descriptions: intervention 1: IV Placebo intervention 2: Intravenous acetaminophen solution 1 g / 100 ml intervention 3: Administration of Reference Standard Endotoxin (RSE) to induce fever. Applicable to both study arms: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.

Protocol documents:
Clinical trial NCT00564629
Conditions: Fever
Sponsor: Mallinckrodt
Start date: 2007-08-01; Completion date: 2007-10-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever induced by a standard dose of endotoxin

Detailed description:
A Phase III, Randomized, Double-Blind, Double-Dummy, Single-Dose Study of the Efficacy and Safety of Intravenous Acetaminophen Versus Oral Acetaminophen for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males

Arms: arm 1: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever. Randomization to receive 1 g of acetaminophen in 100 ml of intravenous solution and oral placebo. arm 2: Administration of a 1 ng/kg body weight test dose of RSE to test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever. Randomization to receive oral acetaminophen 1 g plus 100 ml of intravenous placebo solution.
Interventions: intervention 1: Intravenous acetaminophen plus oral placebo intervention 2: Oral acetaminophen plus IV placebo intervention 3: Reference standard endotoxin (RSE)
Intervention descriptions: intervention 1: Single dose of 1 gm IV acetaminophen intervention 2: Single dose of 1 g PO APAP intervention 3: To subjects in both study arms: Administration of a 1 ng/kg body weight test dose of RSE to induce fever and test for fever response. Observation period of at least 60 minutes to ensure no exaggerated systemic responses, followed by administration of a 4 ng/kg of RSE to induce fever.

Protocol documents:
Clinical trial NCT00664742
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome,dyslipidemia,fluvastatin extended release
Sponsor: Novartis
Start date: 2006-09-01; Completion date: 2007-10-01
Enrollment: 614 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release (80 mg once daily) in patients with metabolic syndrome

Detailed description:

Arms: arm 1: 80 mg once daily, at bedtime.
Interventions: intervention 1: Fluvastatin XL®
Intervention descriptions: intervention 1: Fluvastatin extended release 80 mg

Protocol documents: