ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00189098
Conditions: Chronic Otitis Media
Sponsor: UMC Utrecht
Start date: 2003-02-01; Completion date: 2006-11-01
Enrollment: 101 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries, it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. There is however, no agreement on the management of this disease.

The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim for 6-12 weeks in children suffering from chronic otitis media and otorrhea.

Detailed description:
Chronic suppurative otitis media is one of the most common chronic infections in children worldwide. Symptoms include otorrhea, otalgia and hearing loss. In many countries it is treated primarily with antibiotics; in other countries such as the Netherlands a surgical approach, such as a tonsillectomy, adenoidectomy, placement or removal of tympanostomy tubes or a tympanomastoidectomy is preferred. There is however, no agreement on the management of this disease.

Co-trimoxazole is an inexpensive antibiotic and tolerated well by children, also when long treatment regimens or prophylaxis is necessary. A previously performed retrospective study of 48 children who were referred to the pediatric department of otorhinolaryngology in the UMC Utrecht because of "therapeutic resistant" otorrhea showed promising results; after 3 months follow-up, 52% of the patients were otorrhea free, 25% had otorrhea incidentally and 23% showed no signs of improvement. Therefore, the treatment of chronic otitis media with sulfamethoxazole-trimethoprim for a minimum of six weeks is promising and might be a good alternative to surgical treatment.

The purpose of this study is to determine the effectiveness of treatment with sulfamethoxazole-trimethoprim during 6-12 weeks in children with chronic otitis media and otorrhea for more than 12 weeks.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sulfamethoxazole-trimethoprim intervention 2: Placebo
Intervention descriptions: intervention 1: 18 mg/kg, two times a day intervention 2: None

Protocol documents:
Clinical trial NCT00194025
Conditions: Schizophrenia
Keywords: Schizophrenia Anticonvulsants Valproic Acid Valproate
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2004-11-01; Completion date: 2006-11-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.

Detailed description:
It is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current FDA-approved medications intended to treat their schizophrenia. Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be effective for related conditions such as bipolar disorder (manic depressive illness), and are also used by some physicians in clinical settings in combination with antipsychotic medications to treat symptoms of schizophrenia. Currently Depakote and Depakote ER are approved by the FDA to treat bipolar disorder and to treat seizure disorder. This study will test to see if Depakote and Depakote ER may improve symptoms of schizophrenia as well when added to antipsychotic medications.

Arms: arm 1: All participants received open-label, add-on valproate.
Interventions: intervention 1: Valproate
Intervention descriptions: intervention 1: Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.

Protocol documents:
Clinical trial NCT00205049
Conditions: Hepatitis, Alcoholic
Keywords: acute alcoholic hepatitis
Sponsor: University of Wisconsin, Madison
Start date: 2005-03-01; Completion date: 2006-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

Detailed description:
The goal of this study is to demonstrate the effectiveness of pentoxifylline compared to placebo in AAH while studying putative mechanisms that are plausible and testable. The main hypothesis is that pentoxifylline reduces the 90-day mortality of AAH.

This study never moved forward due to funding issues.

Arms: arm 1: All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days (20-40 treated, 1-20 placebo) with monthly follow up for 90 days.
Interventions: intervention 1: pentoxifylline
Intervention descriptions: intervention 1: daily dosing

Protocol documents:
Clinical trial NCT00245765
Conditions: Chronic Plaque Psoriasis
Keywords: chronic plaque psoriasis, anti TNFα CDP870, Cimzia
Sponsor: UCB Pharma
Start date: 2005-10-01; Completion date: 2006-11-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

Detailed description:

Arms: arm 1: Subcutaneous injections of Placebo every 2 weeks arm 2: Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter arm 3: Subcutaneous injections of 400 mg every 2 weeks
Interventions: intervention 1: Certolizumab Pegol intervention 2: Placebo
Intervention descriptions: intervention 1: * Pharmaceutical Form: solution for injection in pre-filled syringe
* Route of Administration: subcutaneous use intervention 2: Matching Placebo to Certolizumab Pegol

Protocol documents:
Clinical trial NCT00249249
Conditions: Primary Hypercholesterolemia Dyslipidemia
Keywords: hypercholesterolemia dyslipidemia kowa KRE pitavastatin NK-104
Sponsor: Kowa Research Europe
Start date: 2005-10-01; Completion date: 2006-11-01
Enrollment: 830 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of pitavastatin with that of atorvastatin.

Detailed description:
Following a wash-out dietary lead-in period, patients will receive either Atorvastatin or Pitavastatin during 12 weeks, in order to establish the efficacy of pitavastatin in reducing cholesterol levels.

Interventions: intervention 1: Pitavastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00358527
Conditions: Seasonal Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2006-05-01; Completion date: 2006-11-01
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will hope to show that by relieving the participant's nasal symptoms of seasonal allergies using mometasone furoate nasal spray, the participant will obtain a better quality of night-time sleep, which in turn, causes less daytime sleepiness so that he/she can function productively during the day.

Detailed description:

Arms: arm 1: Mometasone Furoate Nasal Spray 200 mcg, once daily. arm 2: None
Interventions: intervention 1: Mometasone Furoate Nasal Spray (MFNS) intervention 2: Placebo
Intervention descriptions: intervention 1: MFNS 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg QD), once daily (each morning), for 28 days. intervention 2: Matching placebo nasal spray: 2 sprays per nostril once daily for 28 days

Protocol documents:
Clinical trial NCT00413972
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2006-04-01; Completion date: 2006-11-01
Enrollment: 392 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study of Vytorin 10/10 (ezetimibe 10 mg with simvastatin 10 mg), Vytorin 10/20 (ezetimibe 10 mg with simvastatin 20 mg), and Vytorin 10/40 (ezetimibe 10 mg with simvastatin 40 mg) compared to placebo administered daily for 8 consecutive weeks in subjects with primary hypercholesterolemia (LDL-C \>3.64 mmol/L \[140 mg/dL\]). The efficacy of daily Vytorin versus placebo in reducing the concentration of LDL-C will be evaluated, and the efficacy of daily Vytorin versus placebo with respect to change in the concentrations of total cholesterol, triglycerides, and HDL-C will be compared. The safety of Vytorin versus placebo will also be assessed.

Detailed description:

Arms: arm 1: Ezetimibe 10 mg with Simvastatin 10 mg arm 2: Ezetimibe 10 mg with Simvastatin 20 mg arm 3: Ezetimibe 10 mg with Simvastatin 40 mg arm 4: None
Interventions: intervention 1: ezetimibe with simvastatin intervention 2: Ezetimibe with Simvastatin intervention 3: Ezetimibe with Simvastatin intervention 4: Placebo
Intervention descriptions: intervention 1: Ezetimibe 10 mg with Simvastatin 10 mg once daily for a total of eight weeks intervention 2: Ezetimibe 10 mg with Simvastatin 20 mg once daily for a total of eight weeks intervention 3: Ezetimibe 10 mg with Simvastatin 40 mg once daily for a total of eight weeks intervention 4: Placebo once daily for a total of eight weeks

Protocol documents:
Clinical trial NCT00461032
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-06-01; Completion date: 2006-11-01
Enrollment: 1162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Detailed description:

Arms: arm 1: montelukast arm 2: Placebo
Interventions: intervention 1: montelukast intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: montelukast 5 mg tablet Once a day (QD) for 8 weeks intervention 2: Placebo to montelukast QD for 8 weeks

Protocol documents:
Clinical trial NCT00747214
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis RA DMARD CRP
Sponsor: Zalicus
Start date: 2004-11-01; Completion date: 2006-11-01
Enrollment: 59 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).

Detailed description:
The primary objective of this study was to:

• Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.

The secondary objectives of this study were to:

* Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.
* Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CRx-102 intervention 2: Placebo intervention 3: DMARD Therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: DMARD therapy can include methotrexate or other DMARD therapy

Protocol documents:
Clinical trial NCT00910663
Conditions: Healthy
Keywords: Bioequivalence Healthy Subjects
Sponsor: Teva Pharmaceuticals USA
Start date: 2006-10-01; Completion date: 2006-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to compare the oral availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially available reference product, CellCept® 250 mg capsule administered to healthy subjects under fed conditions.

Detailed description:
Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Arms: arm 1: Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period. arm 2: CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
Interventions: intervention 1: Mycophenolate Mofetil intervention 2: CellCept®
Intervention descriptions: intervention 1: 250 mg Capsule intervention 2: 250 mg Capsule

Protocol documents:
Clinical trial NCT01389102
Conditions: Hot Flashes
Keywords: Postmenopause Hot Flashes Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens Hormones Hormones, Hormone Substitutes Hormone Antagonists
Sponsor: Lumara Health, Inc.
Start date: 2004-12-01; Completion date: 2006-11-01
Enrollment: 454 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Estradiol treatment is effective at reducing vasomotor symptoms (eg hot flushes) in postmenopausal women. This study will evaluate the safety and efficacy of Evamist.

Detailed description:
Multicenter, randomized, double-blind, placebo-controlled trial evaluating different doses of transdermal estradiol delivered by sray to symptomatic postmenopausal women. The endpoints are the reduction in frequency and severity of hot flushes.

Arms: arm 1: Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 2: Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 3: Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator arm 4: Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 5: Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator arm 6: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
Interventions: intervention 1: Estradiol transdermal one 90 μL spray intervention 2: Estradiol transdermal spray, two 90 μL sprays intervention 3: Estradiol transdermal three 90 μL sprays intervention 4: Placebo transdermal two 90 μL sprays intervention 5: Placebo transdermal three 90 μL sprays intervention 6: Placebo transdermal one 90 μL spray
Intervention descriptions: intervention 1: Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator intervention 2: Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 3: Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 4: Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 5: Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator intervention 6: Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator

Protocol documents:
Clinical trial NCT01809262
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2005-12-01; Completion date: 2006-11-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Primary objective: To investigate bronchodilator effect and safety of single doses of BI 1744 CL inhaled via Respimat inhaler, Secondary objective: to characterize pharmacokinetics of BI 1744 CL. Olodaterol dose 40 mcg was investigated only in the open-label extension part for additional PK assessments which are not defined as primary or secondary endpoints.

Detailed description:

Arms: arm 1: solution for inhalation arm 2: solution for inhalation arm 3: solution for inhalation arm 4: solution for inhalation arm 5: solution for inhalation arm 6: solution for inhalation
Interventions: intervention 1: single dose of 5 mcg intervention 2: single dose of placebo intervention 3: single dose of 40 mcg intervention 4: single dose of 20 mcg intervention 5: single dose of 2 mcg intervention 6: single dose of 10 mcg
Intervention descriptions: intervention 1: solution for inhalation intervention 2: solution for inhalation intervention 3: solution for inhalation intervention 4: solution for inhalation intervention 5: solution for inhalation intervention 6: solution for inhalation

Protocol documents:
Clinical trial NCT01822678
Conditions: Bipolar I Disorder
Sponsor: Bial - Portela C S.A.
Start date: 2005-12-01; Completion date: 2006-11-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Multicentre, double-blind, randomised, parallel-group, placebo-controlled dose-titration study; depending on clinical efficacy, up-titration of dosage 3 and 6 days after start of treatment; maintenance of individual maximum dose for the rest of the total 3-week treatment period; subsequently, down-titration (according to the dose steps and the time intervals of up-titration) and administration of an established anti-manic therapy during the tapering-off period (in patients who discontinued treatment) or entry into a recurrence prevention study (Protocol PRA+SCO/BIA-2093-205; reported under separate cover) as an option for patients who responded to the study treatment

Detailed description:
Objectives:

The primary objective was to evaluate the dose-dependent efficacy of 2 dose-titration regimens of Eslicarbazepine Acetate (ESL) compared with placebo as therapy in patients with acute mania.

The secondary objective was to evaluate the safety and tolerability of 2 dose-titration regimens of Eslicarbazepine Acetate in comparison to placebo.

Arms: arm 1: Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response. arm 2: Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response. arm 3: Group 3: Placebo (change in daily number of tablets administered, according to clinical response).
Interventions: intervention 1: Eslicarbazepine Acetate intervention 2: Eslicarbazepine Acetate intervention 3: Placebo
Intervention descriptions: intervention 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response. intervention 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response. intervention 3: Placebo

Protocol documents:
Clinical trial NCT02075632
Conditions: Eczema Allergy Symptoms Psoriasis Itch
Keywords: Alclometasone dipropionate Eczema Psoriasis Itch
Sponsor: GlaxoSmithKline
Start date: 2006-09-01; Completion date: 2006-11-01
Enrollment: 310 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open-label study to evaluate whether participants follow the duration of use instructions for short-term use of alclometasone dipropionate in a population of participants with itchy skin conditions who would use OTC treatments for relief. The study population will be composed of two different cohorts: chronic condition sufferers (eczema or psoriasis) and participants who suffer from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.

Detailed description:
Approximately 313 participants who are currently suffering from an itchy skin condition caused by eczema or psoriasis or any occasional itchy skin experiences will be enrolled into the study to get 250 participants who complete the study (at least 100 to each of the cohorts). After evaluation of the study criteria, the site staff will dispense product and a diary card to the subject to use over the next 14 days. At the end of the 14 days, each participant will come to the research site to return the remaining product and undergo the study termination interview with the Concentrics nurse via telephone. The study will be conducted in approximately 15 research sites located throughout the United States (US).

Arms: arm 1: Alclometasone dipropionate cream 0.05% will be applied by the participants topically on the affected areas per label instructions for 14 days.
Interventions: intervention 1: Alclometasone dipropionate cream
Intervention descriptions: intervention 1: Alclometasone dipropionate cream 0.05% (15 g)

Protocol documents:
Clinical trial NCT02694718
Conditions: Rectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-03-01; Completion date: 2006-11-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the pathological complete tumor response rate.

Detailed description:

Arms: arm 1: Eligible participants received capecitabine 1000 milligrams per square meter (mg/m\^2) on Days 1-14, and 825 mg/m\^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m\^2/once a day (d) on Day 1 and 50 mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
Interventions: intervention 1: Capecitabine intervention 2: Oxaliplatin
Intervention descriptions: intervention 1: Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m\^2 bid orally on Days 1-14, and at a dose of 825mg/m\^2 bid on Days 22-35 and 43-56. intervention 2: Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m\^2/d intravenously on Day 1 and 50mg/m\^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.

Protocol documents: