ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00511797
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea Dysmenorrheal score Drospirenone DRSP Ethinylestradiol
Sponsor: Bayer
Start date: 2007-07-01; Completion date: 2009-01-01
Enrollment: 249 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate efficacy of drospirenone for dysmenorrhea.

Detailed description:

Arms: arm 1: 1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 2: 1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 3: 1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle arm 4: 1 tablet per day placebo for 28 days in each 28-day cycle
Interventions: intervention 1: SH T04740B intervention 2: SH T00186DF intervention 3: SH T04740F intervention 4: Placebo
Intervention descriptions: intervention 1: Drospirenone 1mg/EE 20µg (ß-CDC) intervention 2: Drospirenone 3 mg/EE 20µg (ß-CDC) intervention 3: Drospirenone 2 mg/EE 20µg (ß-CDC) intervention 4: Placebo

Protocol documents:
Clinical trial NCT00518089
Conditions: Bacterial Conjunctivitis
Sponsor: Allergan
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 859 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis

Detailed description:

Arms: arm 1: Gatifloxacin 0.5% Eye Drops arm 2: Placebo Eye Drops
Interventions: intervention 1: Gatifloxacin 0.5% eye drops intervention 2: placebo eye drops
Intervention descriptions: intervention 1: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily intervention 2: Day 1 = 1 drop of study medication every 2hrs up to 8 times total; day 2-5 = 1 drop twice daily

Protocol documents:
Clinical trial NCT00525265
Conditions: Cardiac Edema
Keywords: Vasopressin antagonist Cardiac Edema Diuretics
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2007-09-01; Completion date: 2009-01-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the pharmacokinetics, pharmacodynamics (urine volume and fluid intake), efficacy(body weight, pulmonary congestion and other congestions including cardiothoracic ratio) and safety of 7-day repeated oral administration of OPC-41061 at 7.5 mg or 15 mg in congestive heart failure (cardiac edema) patients with extracellular volume expansion despite the use of a diuretic.

Detailed description:

Arms: arm 1: OPC-41061 arm 2: placebo
Interventions: intervention 1: OPC-41061(Tolvaptan) intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will be orally administered OPC-41061 7.5 mg or 15 mg once daily after breakfast for seven days. intervention 2: Subjects will be orally administered placebo once daily after breakfast for seven days.

Protocol documents:
Clinical trial NCT00530803
Conditions: Pain Needle Phobia
Keywords: EMLA venipuncture children Synera patch pediatric Lidocaine/prilocaine
Sponsor: Montefiore Medical Center
Start date: 2007-06-01; Completion date: 2009-01-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares the efficacy of the Synera patch with Eutectic Mixture of Local Anesthetics (EMLA) as a topical anesthetic for venipuncture in pediatric patients.

Detailed description:
Venipunctures are common and necessary components of pediatric health care. Unfortunately, many children have "needle phobia" and even a simple procedure, such as a venipuncture, can cause significant stress and anxiety to the patient and the parents involved. Studies have shown that needles are the worst part of hospital/healthcare related visits for children.

The Synera patch uses a controlled heating system to transcutaneously deliver a lidocaine/tetracaine mixture for analgesic effect. No published studies compare the efficacy of the Synera patch with other topical anesthetics in children. The objective of this study is to compare the efficacy of the Synera patch applied for 20 minutes with the efficacy of EMLA Cream applied for 60 minutes in reducing pain associated with venipunctures in children.

Patients, 4-12 years old children requiring venipunctures in clinics, were randomized to receive Synera for 20 minutes or EMLA for 60 minutes. A blinded observer recorded pain scores using a numerical rating scale (NRS). Child and parent assessed pain with the Wong-Baker FACES Scale and the NRS, respectively. The primary outcome was the number of subjects reporting "no pain". Secondary outcomes were parent and observer measures of the child's pain and the presence of skin reactions.

Arms: arm 1: Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA. arm 2: Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure.
Interventions: intervention 1: EMLA Cream intervention 2: Synera Patch
Intervention descriptions: intervention 1: 60 minutes x1 intervention 2: 20 minutes x1

Protocol documents:
Clinical trial NCT00530842
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2007-09-01; Completion date: 2009-01-01
Enrollment: 344 participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to demonstrate that treatment with a free combination of tiotropium and salmeterol provides superior improvement in static lung volumes and exercise tolerance compared to a fixed combination of fluticasone and salmeterol in patients with COPD.

The secondary objective includes assessment of safety.

Detailed description:

Interventions: intervention 1: Tiotropium plus Salmeterol intervention 2: Fluticasone/Salmeterol
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00537277
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2007-10-01; Completion date: 2009-01-01
Enrollment: 161 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Europe.

This is a clinical trial investigating the effectiveness and the safety of using biphasic insulin aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes.

Detailed description:

Arms: arm 1: Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial).
Interventions: intervention 1: biphasic insulin aspart
Intervention descriptions: intervention 1: Treat-to-target dose titration scheme (dose individually adjusted), injected s.c. (under the skin)

Protocol documents:
Clinical trial NCT00544674
Conditions: Lung Cancer
Keywords: extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer
Sponsor: Proacta, Incorporated
Start date: 2007-08-01; Completion date: 2009-01-01
Enrollment: 5 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as PR-104, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well PR-104 works in treating patients with previously untreated or relapsed small cell lung cancer (SCLC).

Detailed description:
OBJECTIVES:

Primary

* Estimate the response rate of PR-104 in patients with treatment-naive or sensitive-relapse small cell lung cancer.
* Evaluate safety of this drug in these patients. Secondary
* Evaluate survival of these patients.
* Evaluate progression-free survival of these patients.
* Evaluate time to progression in these patients.
* Assess the pharmacokinetics (PK) of PR-104 and its alcohol metabolite.
* Estimate the rate of hypoxia using 18F-fluoromisonidazole (FMISO) positron emission topography (PET) imaging.
* Collect plasma samples for assessment of potential biomarkers of tumor hypoxia.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type (treatment-naive vs sensitive-relapse).

Patients receive PR-104 intravenously (IV) over 1 hour on day 1. Treatment repeats every 21 days for up to 4 courses (for treatment-naive patients) or in the absence of disease progression or unacceptable toxicity (for sensitive-relapse patients).

PK studies are performed during course 1 and after course 3. Blood is collected at baseline, during course 1, and at study completion for biomarker studies of tumor hypoxia (plasma proteins). Patients also undergo FMISO PET and fludeoxyglucose F18 (FDG) PET scans at baseline and after the second course of study therapy.

Arms: arm 1: PR104 will be administered once every 21 days by IV
Interventions: intervention 1: PR104 intervention 2: F-18-fluoromisonidazole
Intervention descriptions: intervention 1: administered at a dose of 1100 mg/m\^2 by intravenous infusion over 1 hour and repeated every three weeks intervention 2: administered intravenously prior to PET scan

Protocol documents:
Clinical trial NCT00545766
Conditions: Prostate Cancer
Keywords: Prostate Cancer Hormone Refractory Vinflunine Salvage Chemotherapy
Sponsor: SCRI Development Innovations, LLC
Start date: 2007-05-01; Completion date: 2009-01-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Currently, there are no established 2nd-line or salvage chemotherapy regimens for patients with HRPC, many of whom retain an excellent performance status. The antitumor characteristics and toxicity profile of vinflunine make it an ideal agent to be investigated in this setting. In this Phase II trial, we plan to evaluate the efficacy, toxicity, and feasibility of administering IV vinflunine at a dose of 320 mg/m2 q3w as salvage chemotherapy in patients with HRPC. The patients will be evaluated for response, survival, and toxicity. If significant antitumor activity is demonstrated, further evaluation of this agent either alone or combination regimens and at earlier stages of disease will be indicated.

Detailed description:
This is a non-randomized (single-arm), open-label, multi-center, single-agent, Phase II study of vinflunine as second- or third-line treatment of subjects with HRPC. The primary objective of the study is to evaluate the efficacy of vinflunine in the salvage treatment, as measured by Protein-Specific Antigen (PSA) Response Rate endpoint.

The primary objective of this study is as follows:

To evaluate the efficacy (as measured by the PSA response rate) of IV vinflunine administered q3w in HRPC patients who have progressed after one or two previous chemotherapy regimens.

Secondary Objectives

The secondary objectives of this study are as follows:

* To evaluate the efficacy of IV vinflunine administered q3w in HRPC patients who have previously received chemotherapy (one or two regimens), as measured by:

  * Time to PSA progression
  * Overall survival
  * Palliative response in patients with an Analgesic Score (AS) ≥10 and stable baseline pain
  * Health-Related Quality of Life
* To assess the efficacy (as measured by the PSA response rate) of IV vinflunine in HRPC patients based on their response to prior chemotherapy
* Chemotherapy responsive - previous response to most recent chemotherapy regimen lasting \>2 months after completion.
* Chemotherapy refractory - failure to respond to, or progression during or within three months of completing last chemotherapy.
* To assess the response rate to IV vinflunine in the subset of patients with measurable disease, as measured by traditional Response Evaluation Criteria in Solid Tumors (RECIST) criteria (Therasse et al. 2000).
* To evaluate the safety of IV vinflunine administered every three weeks in HRPC patients who have previously received chemotherapy.

Arms: arm 1: None
Interventions: intervention 1: Vinflunine
Intervention descriptions: intervention 1: Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.

Protocol documents:
Clinical trial NCT00549042
Conditions: Chronic Low Back Pain
Keywords: Back Pain Chronic Low Back Pain Chronic Back Pain Pain Chronic Pain
Sponsor: Mallinckrodt
Start date: 2007-10-01; Completion date: 2009-01-01
Enrollment: 459 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test an experimental drug called OROS® hydromorphone hydrochloride (HCl) (NMED-1077), a once daily opioid analgesic that can relieve pain. A large number of clinical studies have been conducted to test this drug. OROS hydromorphone HCl is currently approved in both the US and Europe to treat chronic pain.

The purpose of this study is to compare OROS hydromorphone to placebo to see if it is safe and efficacious.

Detailed description:

Arms: arm 1: OROS hydromorphone tablets administered orally once daily in total daily doses of 12, 16, 24, 32, 40, 48, or 64 mg arm 2: Matching placebo tablets orally once daily (number and dosage of tablets to match the number and dosage of the stable dose of OROS hydromorphone obtained in the Conversion and Titration phase).
Interventions: intervention 1: OROS hydromorphone intervention 2: Placebo
Intervention descriptions: intervention 1: hydromorphone 12, 16, 24, 32, 40, 48, or 64 mg tablets intervention 2: Placebo

Protocol documents:
Clinical trial NCT00553839
Conditions: The Pk of IV Ketamine in Children With Heart Disease
Keywords: anesthesia children ketamine pharmacokinetics
Sponsor: Stanford University
Start date: 2007-07-01; Completion date: 2009-01-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dosing of medications is based on the plasma level achieved with a given dose and how long the medicine remains in the body. This study is called pharmacokinetics-that is, what the body does to the medication. Ketamine is an intravenous medication used for anesthesia and sedation in children. However the pharmacokinetics of Ketamine has not been systematically studied. We propose to study the pharmacokinetics of ketamine in different age groups of children ranging from infants to teenagers.

Detailed description:
This is an open label study that will be conducted in infants and children presenting for procedures (eg., surgery or cardiac catheterization) at Stanford and Lucile Packard Children's hospital in California and at The Children's Hospital in Denver, CO. Patients with abnormal kidney or liver functions will be excluded from the study as the dysfunction in these organs affects the clearance of medications from the body and affects dosing. Preterm neonates will also be excluded. All patients will be premedicated and anesthetised at the discretion of the anesthesia faculty providing clinical care for the child. Once the patient's procedure is underway, a 0.5 cc blood sample will be drawn from an intravenous line. This is the preload blood sample (T0). Following this a 2mg/kg intravenous bolus of Ketamine will be administered over 5 minutes (this is the usual dose and manner in which ketamine is administered). Five minutes after the bolus, timed blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus. (Total 14 blood samples; total blood required is 7 mls for the entire study). When the procedure is completed the anesthesiologist will awaken the patient as per their usual practice. Blood samples that still need drawing will be done in the post-anesthesia recovery room or intensive care or ward-any location where the patient is likely to remain after the surgery.

Arms: arm 1: Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given as part of general anesthesia for procedure
Interventions: intervention 1: ketamine hydrochloride
Intervention descriptions: intervention 1: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus.

Protocol documents:
Clinical trial NCT00555009
Conditions: Brain Injuries Growth Hormone Deficiency
Keywords: traumatic brain Injury, cognitive function
Sponsor: Pfizer
Start date: 2008-03-01; Completion date: 2009-01-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

Detailed description:
The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Genotropin intervention 2: Placebo
Intervention descriptions: intervention 1: Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks. intervention 2: Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

Protocol documents:
Clinical trial NCT00561951
Conditions: Overactive Bladder
Sponsor: Pfizer
Start date: 2007-11-01; Completion date: 2009-01-01
Enrollment: 951 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of fesoterodine in comparison to placebo for overactive bladder.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: fesoterodine fumarate intervention 2: Placebo intervention 3: fesoterodine fumarate
Intervention descriptions: intervention 1: 8mg tablets OD for 12 weeks intervention 2: Corresponding placebo tablets OD for 12 weeks intervention 3: 4mg tablets OD for 12 weeks

Protocol documents:
Clinical trial NCT00567996
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic obstructive pulmonary disease, indacaterol, salmeterol, placebo controlled
Sponsor: Novartis
Start date: 2007-11-01; Completion date: 2009-01-01
Enrollment: 1002 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.

Detailed description:

Arms: arm 1: Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 2: Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening.

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study. arm 3: Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI).

Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 150 μg intervention 2: Salmeterol 50 μg intervention 3: Placebo to Indacaterol intervention 4: Placebo to Salmeterol
Intervention descriptions: intervention 1: Indacaterol 150 μg once daily (o.d) inhaled intervention 2: Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler intervention 3: Placebo to Indacaterol inhaled via SDDPI. intervention 4: Placebo to salmeterol delivered via a proprietary dry powder inhaler

Protocol documents:
Clinical trial NCT00569192
Conditions: Asthma
Keywords: asthmatic children
Sponsor: Allergan
Start date: 2007-12-01; Completion date: 2009-01-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and efficacy of two doses of MAP0010 versus placebo in asthmatic infants and children, 12 months to 8 years of age, over a 12-week treatment period.

Detailed description:

Arms: arm 1: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks arm 2: Placebo delivered by nebulization twice daily for 12 weeks arm 3: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
Interventions: intervention 1: 0.135mg MAP0010 intervention 2: 0.25mg MAP0010 intervention 3: Placebo
Intervention descriptions: intervention 1: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks intervention 2: 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks intervention 3: Placebo delivered by nebulization twice daily for 12 weeks

Protocol documents: