ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01336738
Conditions: Diabetes, Type 2
Keywords: Phase 2 safety and efficacy study with PF-04991532 Type 2 diabetes
Sponsor: Pfizer
Start date: 2011-06-01; Completion date: 2012-03-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
B2611002 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 5 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Detailed description:

Arms: arm 1: Matching placebo for PF-04991532 and Sitagliptin arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: 150 mg PF-04991532 intervention 3: 450 mg PF-04991532 intervention 4: 750 mg PF-04991532 intervention 5: Sitagliptin 100 mg
Intervention descriptions: intervention 1: Tablets (n=6), 0 mg, once daily for 84 days intervention 2: Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days intervention 3: Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days intervention 4: Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days intervention 5: Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days

Protocol documents:
Clinical trial NCT01338870
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 2 safety and efficacy study with PF-04991532 Type 2 diabetes
Sponsor: Pfizer
Start date: 2011-06-01; Completion date: 2012-03-01
Enrollment: 301 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
B2611003 is designed to study how safe and effective an investigational medication (PF-04991532) is in people with Type 2 diabetes. Subjects in the study will receive 1 of 6 treatments for 3 months. One of the treatments will be sitagliptin which is an approved drug, and another treatment will be placebo, which does not contain active ingredient.

Detailed description:

Arms: arm 1: Placebo for PF-04991532 and sitagliptin arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
Interventions: intervention 1: Placebo intervention 2: 25 mg PF-04991532 intervention 3: 75 mg PF-04991532 intervention 4: 150 mg PF-04991532 intervention 5: 300 mg PF-04991532 intervention 6: Sitagliptin 100 mg
Intervention descriptions: intervention 1: Tablets (n=4), 0 mg twice daily for 84 days intervention 2: Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days intervention 3: Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days intervention 4: Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days intervention 5: Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days intervention 6: Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.

Protocol documents:
Clinical trial NCT01362491
Conditions: Pain
Keywords: Headache
Sponsor: Pfizer
Start date: 2011-06-01; Completion date: 2012-03-01
Enrollment: 226 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Ibuprofen Sodium intervention 2: Standard Ibuprofen intervention 3: Placebo
Intervention descriptions: intervention 1: Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen) intervention 2: Single-dose of standard ibuprofen tablets (400mg) intervention 3: Single-dose of placebo

Protocol documents:
Clinical trial NCT01367119
Conditions: Depression
Keywords: Depression Electroconvulsive therapy Ketamine Methohexital
Sponsor: Mayo Clinic
Start date: 2011-05-01; Completion date: 2012-03-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Does the use of ketamine as the anesthetic medication in electroconvulsive therapy (ECT) accelerate the antidepressant effect of ECT?

The study hypothesis was that depressed subjects receiving ECT with ketamine as the anesthetic agent would demonstrate a faster rate of improvement, defined as lower depression ratings after the second ECT than depressed patients receiving ECT with the usual anesthetic agent.

Detailed description:
There are several drugs available to induce anesthesia for electroconvulsive therapy (ECT), a psychiatric treatment for major depressive illness. The most commonly utilized of these include methohexital, thiopental, etomidate, and propofol. Recently, there has been interest in the use of ketamine in sub-anesthetic doses to treat major depressive illness.

In this randomized, blinded trial, depressed subjects scheduled to be treated with ECT were anesthetized with either ketamine or methohexital at doses of approximately 1.0 mg/kg for each drug. Patients received the same drug for up to six of their ECT treatments. Outcome measures included assessments of depressive severity, cognition, post-anesthesia side effects, and hemodynamics.

Subjects were to be followed with as long as they were receiving inpatient ECT treatments. The number of treatments was determined entirely by their primary psychiatric team, also blind to anesthetic, as per usual care. In other words, this study did not determine when to terminate the ECT course.

Arms: arm 1: Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT). arm 2: Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
Interventions: intervention 1: Ketamine intervention 2: methohexital
Intervention descriptions: intervention 1: Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic. intervention 2: Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.

Protocol documents:
Clinical trial NCT01374919
Conditions: Iron Deficiency Anemia
Keywords: Intravenous iron ferumoxytol iron deficiency anemia Treatment of iron deficiency Intolerance of or ineffectiveness of oral iron
Sponsor: Auerbach Hematology Oncology Associates P C
Start date: 2011-06-01; Completion date: 2012-03-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to recruit 30 patients who have been referred to Auerach Hematology Oncology Assoc. for the treatment of iron defeciency anemia with iv iron (Ferumoxytol 1020 mg) administered via infusion pump over 15 minutes.

To ascertain acute safety and tolerability of ferumoxytol during immediate post dosing observation period.

Assess additional safety profile and laboratory assessment at follow up visit and interim telephone follow up.

Detailed description:
Ferumoxytol, a modified iron dextran, which allows the rapid administration of IV iron without free iron release, was approved for a 510 mg injection to be administered in not less than 17 seconds. Although this represents a felicitous treatment for patients who come frequently, such as dialysis and chemotherapy patients, multiple publications suggest that full dose replacement is usually at the 1000 mg level. No studies extant are available with this dosing schedule for ferumoxytol. In this trial, iron deficient patients with hemoglobin levels of \<11.0 grams per deciliter will be consented to received 1020 mg (two 510 mg vials) of ferumoxytol in 15 minutes. Vital signs will be performed at 5, 10, 15, 30 and 60 minutes. Followup phone calls for any clinical adverse events will be made at 24-48 hours and one week after administration. At four weeks follow-up hematologic and serologic (iron parameters) will be made along with a physician visit.

Arms: arm 1: IV administration of 1020 mg of ferumoxytol in 15 minutes
Interventions: intervention 1: ferumoxytol
Intervention descriptions: intervention 1: IV administration of 1020 mg of ferumoxytol in 15 minutes

Protocol documents:
Clinical trial NCT01375075
Conditions: Dyslipidemias
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2012-03-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if 12 weeks of treatment with LY2484595 administered as a monotherapy will significantly increase high-density lipoprotein cholesterol (HDL-C) and decrease low-density lipoprotein cholesterol (LDL-C) in Japanese participants.

Detailed description:

Arms: arm 1: Administered orally once daily for 12 weeks arm 2: Administered orally once daily for 12 weeks arm 3: Administered orally once daily for 12 weeks arm 4: Administered orally once daily for 12 weeks arm 5: Administered orally once daily for 12 weeks arm 6: Administered orally once daily for 12 weeks
Interventions: intervention 1: LY2484595 intervention 2: Placebo intervention 3: Atorvastatin
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01379183
Conditions: Healthy
Keywords: Healthy Men Women No known gastrointestinal disease Aged between 18-70 years
Sponsor: Mayo Clinic
Start date: 2011-06-01; Completion date: 2012-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Magnetic Resonance Imaging (MRI) has proven to be a valuable imaging technique for suspected small bowel disease. This technique depends, in part, on adequate distension of the small bowel. This is accomplished by administering large volumes of a non-absorbable oral contrast material prior to the examination, which typically produces excellent distension of the distal small bowel and stomach, but poor distension of the proximal small bowel. Erythromycin is a common antibiotic that is known to promote stomach emptying and is used to treat diabetics with gastroparesis (poor stomach emptying.) The hypothesis of this study was that erythromycin will increase gastric emptying and hence improve small and large intestinal distention during MRI.

Detailed description:
Gastric, small, and large intestinal volumes were assessed with MRI after ingestion of a low concentration of barium sulfate solution (1350 mL) and randomization to erythromycin 200 mg i.v.) or placebo in 40 healthy volunteers. Magnetic Resonance Images of the abdomen were acquired with a torso phased array coil and a 1.5 tesla magnet.

Arms: arm 1: Erythromycin 200 mg i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging arm 2: Matching placebo i.v. suspension, Barium Sulfate Solution, and Magnetic Resonance Imaging
Interventions: intervention 1: Erythromycin intervention 2: Placebo intervention 3: Magnetic Resonance Imaging intervention 4: Barium Sulfate Solution
Intervention descriptions: intervention 1: 200 mg suspension intervention 2: 200 mg suspension intervention 3: An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel. intervention 4: Participants will be given a low concentration of barium sulfate solution (1350 mL) prior to the MRI procedure. Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.

Protocol documents:
Clinical trial NCT01405950
Conditions: Spasticity Due to Cerebral Palsy
Sponsor: Acorda Therapeutics
Start date: 2011-05-01; Completion date: 2012-03-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Single-Dose, Phase 1b, Multicenter, Open-Label Study to Assess the Pharmacokinetics, Safety and Tolerability, and Pharmacodynamics of Tizanidine at 4 Different Oral Dose Levels in Pediatric Subjects 2 to 16 Years Old With Mild to Moderate Spasticity Due to Cerebral Palsy.

Detailed description:
Evaluation of the study's progress after the amendment remained challenging with continued pre-screen failures noted in areas of Botox injection inclusion; family participation refusal / disinterest and gastric or jejunostomy tube placement. A third protocol amendment to improve enrollment was discussed with the Investigators who did not believe further amendment would overcome the barriers expressed by parents that would subject their children to an intense study time commitment without direct benefit. The investigative sites were notified that the study was closed to enrollment March 27, 2012.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Zanaflex Capsules intervention 2: Zanaflex Capsules intervention 3: Zanaflex Capsules intervention 4: Zanaflex Capsules
Intervention descriptions: intervention 1: 0.025 mg/kg intervention 2: 0.05 mg/kg intervention 3: 0.075 mg/kg intervention 4: 0.1 mg/kg

Protocol documents:
Clinical trial NCT01415986
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Advanced head and neck cancer Squamous cell carcinoma SCC HNSCC
Sponsor: University of Arkansas
Start date: 2010-11-01; Completion date: 2012-03-01
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Presently, there is no effective treatment for patients with advanced head and neck cancer (AHNC) that failed to respond to the standard therapy (radiation, chemotherapy and surgery) in the US. These patients are deemed incurable AHNC. In the European Union (EU), interstitial photodynamic therapy (I-PDT) with Temoporfin is approved for the treatment of patients with incurable AHNC. Well designed EU studies have shown that I-PDT with Temoporfin can provide worthwhile palliation by reducing tumor size, bleeding and pain in 53% - 60% of patients with incurable AHNC. This is a significantly higher rate in comparison to the reported response rate of palliative chemotherapy (6-30%). However, the EU studies did not correlate quantitative tumor response with clinical outcome. In addition, quality of life (QoL) improvements associated with I-PDT of AHNC using Temoporfin were also not evaluated.

The objective of this study is to quantify the tumor response and patient's QoL to I-PDT with Temoporfin. Successfully meeting this objective will give us the tools the investigators need to design larger studies to significantly improve the management and QoL of patients with AHNC.

Detailed description:
This is a non-randomize, open label, Pilot phase II study with 5 consenting subjects. The specific aims of this study are:

Aim 1: Quantitate local tumor response in patients with incurable AHNC treated with I-PDT with Temoporfin.

Aim 2: Evaluate the changes in QoL in patients with incurable AHNC treated with I-PDT with Temoporfin.

Arms: arm 1: None
Interventions: intervention 1: Temoporfin intervention 2: Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)
Intervention descriptions: intervention 1: A single dose of 0.15 mg of Temoporfin per kilogram of body weight will be administered by slow intravenous injection into a deep vein (such as the antecubital vein) in not less than 6 minutes. intervention 2: Light dose of 20 J/cm, at a rate of 100 mW/cm, will be delivered to the target tumor and margins, within 200 seconds.

Protocol documents:
Clinical trial NCT01422915
Conditions: Erythropoietic Protoporphyria
Keywords: Sorbent Resin EPP Cutaneous porphyria Adult over age 21 without intercurrent illness not pregnant willing to participate
Sponsor: Brigham and Women's Hospital
Start date: 2011-05-01; Completion date: 2012-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators demonstrated that cholestyramine is an effective binding agent in vitro for porphyrins. A few isolated case reports of treatment of individuals with a cutaneous porphyria suggest that cholestyramine and colestipol effectively remove porphyrins. Hypothesis: orally administered colestipol will effectively reduce sun sensitivity and lower erythrocyte porphyrin concentrations in subjects with erythropoietic protoporphyria (EPP).

Detailed description:
Four adults with proven EPP volunteered as subjects for this study. First period: Subjects received 1 gm colestipol twice daily for \~45 days, then 2 gm twice daily for \~45 days. Labs included CBC; liver chemistries including cholesterol; serum iron, TIBC and ferritin; erythrocyte and plasma protoporphyrin concentrations; and completion of sun exposure questionnaire focused on cutaneous manifestations every 2-4 weeks. Second period: Subjects received colestipol tablets, 2 grams twice daily, completing the sun exposure questionnaire and protoporphyrin determinations \~monthly for 5-6 months.

Arms: arm 1: 2 grams morning and bedtime for 180 days
Interventions: intervention 1: Colestipol
Intervention descriptions: intervention 1: 2 grams morning and bedtime for 90 days.

Protocol documents:
Clinical trial NCT01423916
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Schizophrenia QTc Interval
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2011-07-01; Completion date: 2012-03-01
Enrollment: 218 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective subjects. The goals of this trial are three-fold:

* To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for placebo
* To determine the effect of moxifloxacin on QTcI
* To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI

Detailed description:

Arms: arm 1: Arm 1 will be administered 4 mg OPC-34712 once daily (QD) for 11 days and OPC-34712 placebo for 1 day. arm 2: Arm 2 will be administered 12 mg OPC-34712 QD for 11 days and OPC-34712 placebo for 1 day. arm 3: Arm 3 will be administered 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for 1 day and OPC-34712 placebo QD for 11 days. arm 4: Arm 4 will be administered OPC-34712 placebo QD for 11 days and 400 mg moxifloxacin (positive control) plus OPC-34712 placebo for one day.
Interventions: intervention 1: OPC-34712 (4mg) intervention 2: Moxifloxacin intervention 3: OPC-34712 (12mg) intervention 4: Placebo
Intervention descriptions: intervention 1: Arms assigned to this intervention receive 4mg. intervention 2: Arms assigned to this intervention will receive 400mg. intervention 3: Arms assigned to this intervention receive 12mg. intervention 4: OPC-34712 placebo

Protocol documents:
Clinical trial NCT01425814
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2011-08-01; Completion date: 2012-03-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the pharmacodynamics (bronchodilation) of single doses of inhaled LAS100977 in COPD patients.

Detailed description:

Arms: arm 1: Single dose, double blind treatment period arm 2: Single dose, double blind treatment period arm 3: Single dose, double blind treatment period arm 4: Single dose, double blind treatment period arm 5: Single dose, double blind treatment period arm 6: Single dose, double blind treatment period
Interventions: intervention 1: LAS100977 intervention 2: LAS100977 intervention 3: LAS100977 intervention 4: LAS100977 intervention 5: Reference intervention 6: Placebo
Intervention descriptions: intervention 1: Dry powder inhalation,Once daily, single dose intervention 2: Dry powder inhalation,Once daily, single dose intervention 3: Dry powder inhalation,Once daily, single dose intervention 4: Dry powder inhalation,Once daily, single dose intervention 5: Dry powder inhalation (capsule),single dose intervention 6: Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose

Protocol documents:
Clinical trial NCT01427504
Conditions: Hepatitis C HIV
Keywords: HCV HIV
Sponsor: University of Colorado, Denver
Start date: 2011-08-01; Completion date: 2012-03-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators believe that boceprevir's drug concentrations will be reduced when administered in combination with etravirine. The investigators believe that etravirine's drug concentrations will be increased when administered in combination with boceprevir. Additionally, the investigators believe that boceprevir and etravirine are safe when administered alone or in combination.

Detailed description:
To investigate the potential for drug interactions between boceprevir and etravirine, participants will receive each drug alone and the drugs in combination for 11-14 days. The pharmacokinetics of boceprevir and etravirine when given in combination vs. alone will be compared.

Arms: arm 1: Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine. arm 2: Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only. arm 3: Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine. arm 4: Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only. arm 5: Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only. arm 6: Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
Interventions: intervention 1: boceprevir; etravirine
Intervention descriptions: intervention 1: boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.

Protocol documents:
Clinical trial NCT01440517
Conditions: Diabetes Mellitus Heart Failure
Keywords: CE-MRI - Contrast-enhanced magnetic resonance imaging DM - Diabetes mellitus EKG - Echocardiography HFPEF - Heart failure preserved left ventricular ejection fraction LVEF - Left Ventricular Ejection Fraction
Sponsor: GE Healthcare
Start date: 2011-08-01; Completion date: 2012-03-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the results of 99mTc maraciclatide scintigraphy in diabetic subjects with HFPEF. A maximum of 20 subjects with Diabetes Mellitus (DM) and Heart Failure With Preserved Left Ventricular Ejection Fraction (HFPEF) will be enrolled and imaged with 99mTc maraciclatide. In addition, a maximum of 10 subjects with DM and diastolic dysfunction but no diagnosis of heart failure (HF) will be enrolled and imaged with 99mTc-maraciclatide.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Tc99m-Maraciclatide
Intervention descriptions: intervention 1: Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection

Protocol documents: