ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00941668
Conditions: Gingivitis
Sponsor: Colgate Palmolive
Start date: 2007-01-01; Completion date: 2008-08-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the anti-inflammatory efficacy of a dentifrice

Detailed description:

Arms: arm 1: Triclosan/Copolymer/fluoride toothpaste arm 2: sodium monofluorophosphate toothpaste
Interventions: intervention 1: Triclosan/Copolymer/fluoride toothpaste intervention 2: sodium monofluorophosphate toothpaste
Intervention descriptions: intervention 1: Twice daily usage intervention 2: Twice daily usage

Protocol documents:
Clinical trial NCT01008696
Conditions: Reflux Esophagitis
Keywords: Reflux esophagitis Rabeprazole Lansoprazole
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2007-05-01; Completion date: 2008-08-01
Enrollment: 217 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the treatment effects of rabeprazole and lansoprazole depending on the genotyping (process of determining the genetic constitution) of CYP2C19 in treating reflux esophagitis (caused by gastroesophageal reflux; deterioration of the protective lining on the inner wall of the lower esophagus); and to evaluate the cure rate of reflux esophagitis on endoscopy (a thin flexible tube with a microscopic camera at the end which is passed down your throat into the esophagus, stomach, and duodenum) after treatment with rabeprazole and lansoprazole.

Detailed description:
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), randomized (study drug assigned by chance) study in participants with reflux esophagitis. The study will include 4 visits: Visit 1 (Screening period of up to 14 days), Visit 2 (Day 1), Visit 3 (Day 29+3), and Visit 4 (Day 56). After Screening, eligible participants will be analyzed on Visit 2 (Day 1) for symptoms during past week, At visit 3 (Day 29+3) participants will be randomly assigned to 1 of the 2 treatment groups: rabeprazole 20 milligram (mg) or lansoprazole 30 mg group. Participants will receive rabeprazole 20 mg tablet orally once daily for 28 to 56 days or lansoprazole 30 mg capsule orally once daily for 28 to 56 days. A post-study follow-up visit will be conducted only if participant will be affected by any serious adverse event within 30 days after the completion of study drug. Participants will primarily be assessed for the cure rate of reflux esophagitis based on endoscopy of 2 groups. Participants' safety will be monitored throughout the study.

Arms: arm 1: Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. arm 2: Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.
Interventions: intervention 1: Rabeprazole intervention 2: Lansoprazole
Intervention descriptions: intervention 1: Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days. intervention 2: Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days.

Protocol documents:
Clinical trial NCT01556763
Conditions: Schizophrenia Schizoaffective Disorder Central Nervous System Diseases
Keywords: Schizophrenia Schizoaffective CNS
Sponsor: FORUM Pharmaceuticals Inc
Start date: 2008-04-01; Completion date: 2008-08-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study in patients with schizophrenia is designed to provide preliminary evidence of the safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2 doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic medication.

Detailed description:
Study drug will be supplied as capsules and will be orally administered once daily for a total of 21 days. Eligible subjects will be admitted to an inpatient study unit on Day -6 (six days before the first dose of study drug is administered) and will remain confined to the inpatient study unit throughout the dosing phase. Safety assessments, PK sampling, and cognitive testing will be performed.

Arms: arm 1: Matching placebo was administered as one capsule per day for 21 days. arm 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. arm 3: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
Interventions: intervention 1: EVP-6124 (0.3 mg/day) intervention 2: EVP-6124 (1.0 mg/day) intervention 3: Placebo intervention 4: Antipsychotic therapy
Intervention descriptions: intervention 1: EVP-6124 was administered as one 0.3 mg capsule per day for 21 days. intervention 2: EVP-6124 was administered as one 1.0 mg capsule per day for 21 days. intervention 3: Matching placebo was administered as one capsule per day for 21 days. intervention 4: Concomitant therapy with antipsychotic medication (aripiprazole \[10 to 30 mg/day\], olanzapine \[10 to 20 mg/day\], paliperidone \[3 to 12 mg/day\], or risperidone \[2 to 16 mg/day\]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.

Protocol documents:
Clinical trial NCT01565330
Conditions: Alzheimer Disease
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2008-03-01; Completion date: 2008-08-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.

Detailed description:

Arms: arm 1: Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel arm 2: Healthy controls who received 111MBq (3 mCi) of florbetapir F 18 arm 3: Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18 arm 4: Healthy controls who received 370MBq (10 mCi) of florbetapir F 18.
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: single dose IV injection

Protocol documents:
Clinical trial NCT01892657
Conditions: Skin Irritation
Keywords: Cetaphil Daily Facial Moisturizer with SPF 50+ Hypoallergenicity Skin Irritation
Sponsor: Galderma R&D
Start date: 2008-03-01; Completion date: 2008-08-01
Enrollment: 128 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study examined the possible sensitization and irritation effects of a moisturizer with sunscreen SPF 50+.

Detailed description:
The design for this study is standard for human repeat insult patch tests. To test the moisturizer with sunscreen SPF 50+ for the potential to induce contact sensitization by repetitive applications, healthy subjects received 9 applications at 48 to 72 hour intervals of the moisturizer to the upper back. Patches were remained on the skin for approximately 48 to 72 hours. Twelve to 24 days after the previous applications, subjects were patched with the moisturizer at the original site and an alternative site for 48 hours.

Arms: arm 1: All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
Interventions: intervention 1: Facial Moisturizer with SPF 50+
Intervention descriptions: intervention 1: All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+

Protocol documents:
Clinical trial NCT00672984
Conditions: Healthy Volunteers
Keywords: QT/QTc
Sponsor: Shire
Start date: 2008-04-18; Completion date: 2008-08-07
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess the effect of immediate-release guanfacine hydrochloride, administered at therapeutic and supratherapeutic doses, on QT/QTc in healthy normal males and females

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: immediate release guanfacine hydrochloride intervention 2: moxifloxacin intervention 3: Placebo
Intervention descriptions: intervention 1: Subjects will receive 2x2mg immediate-release guanfacine on day 1. Subjects will receive 4x2mg immediate-release guanfacine on day 6. intervention 2: Subjects will receive 400mg of moxifloxacin on day 1. Subjects will receive 400mg of moxifloxacin on day 6. intervention 3: Subjects will receive placebo on Day 1. Subjects will receive placebo on Day 6.

Protocol documents:
Clinical trial NCT00482612
Conditions: Insomnia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-07; Completion date: 2008-08-11
Enrollment: 526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.

Detailed description:

Arms: arm 1: Esmirtazapine 1.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 2: Esmirtazapine 3.0 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 3: Esmirtazapine 4.5 mg tablet, oral administration in the evening, once daily, for 2 weeks arm 4: Placebo to esmirtazapine
Interventions: intervention 1: Esmirtazapine intervention 2: Placebo
Intervention descriptions: intervention 1: Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia \[USP\] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime. intervention 2: Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.

Protocol documents:
Clinical trial NCT00298038
Conditions: Hepatic Encephalopathy
Sponsor: Bausch Health Americas, Inc.
Start date: 2005-12-19; Completion date: 2008-08-15
Enrollment: 299 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the study drug is safe and effective in preventing hepatic encephalopathy (HE).

Detailed description:

Arms: arm 1: Participants were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation. arm 2: Participants were administered a single matching placebo tablet 2 times per day (approximately every 12 hours) for 6 months or until a breakthrough episode of hepatic encephalopathy or another reason for discontinuation.
Interventions: intervention 1: Rifaximin intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00477659
Conditions: Alzheimer's Disease
Keywords: Functional magnetic resonance imaging examination Alzheimer's Disease Donepezil hydrochloride Aricept
Sponsor: Eisai Inc.
Start date: 2007-07-23; Completion date: 2008-08-15
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study was to identify neural correlates of cognitive improvement after 3 months of donepezil hydrochloride treatment using either or both of two functional magnetic resonance imaging (fMRI) measures - the functional Hippocampus Connectivity Index (HCI) and Cerebral Blood Flow (CBF) Perfusion; in the Medial Temporal Lobe (MTL) network in subjects in the early stage of Alzheimer's Disease (AD).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Donepezil hydrochloride
Intervention descriptions: intervention 1: Donepezil hydrochloride 5 mg per day orally, once daily for 4 weeks, followed by 10 mg per day (two 5-mg tablets) for 8 weeks

Protocol documents:
Clinical trial NCT00424372
Conditions: Neuralgia, Postherpetic
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-01-12; Completion date: 2008-08-19
Enrollment: 126 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
To evaluate the safety of the long-term use of pregabalin.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: pregabalin
Intervention descriptions: intervention 1: Dosage: 150-600 mg/day (75-300 mg bid), oral administration, Treatment duration: 52 weeks

Protocol documents:
Clinical trial NCT00314951
Conditions: Clostridium Infections Diarrhea
Keywords: CDAD, Clostridium difficile, diarrhea Clostridium difficile-Associated Diarrhea
Sponsor: Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2006-05-02; Completion date: 2008-08-21
Enrollment: 629 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD).

Detailed description:
The primary objective of this pivotal study is to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). The cure rates at end of therapy and recurrence rates will be evaluated and compared.

Arms: arm 1: Participants receiving fidaxomicin 200 mg capsules orally two times daily (every 12 hours \[q12h\] regimen) with intermittent matching placebo to fidaxomicin arm 2: Participants receiving vancomycin 125 mg capsules orally four times daily (every 6 hours \[q6h\] regimen).
Interventions: intervention 1: Fidaxomicin intervention 2: Vancomycin intervention 3: Matching Placebo to Fidaxomicin
Intervention descriptions: intervention 1: 200 mg oral capsules two times daily (q12h regimen) intervention 2: 125 mg capsules q6hr (4 times a day) intervention 3: Matching Placebo to Fidaxomicin administered two times daily (intermittently with fidaxomicin dosing)

Protocol documents:
Clinical trial NCT00137969
Conditions: Lupus Erythematosus, Systemic
Keywords: Rituxan SLE Lupus
Sponsor: Genentech, Inc.
Start date: 2005-05-10; Completion date: 2008-08-25
Enrollment: 262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase II/III, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of rituximab compared with placebo when combined with a single stable background immunosuppressive medication in subjects with moderate to severe systemic lupus erythematosus (SLE). The primary efficacy endpoint of the trial will be evaluated at 52 weeks.

Detailed description:

Arms: arm 1: Participants will receive rituximab 1000 mg intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion. arm 2: Participants will receive placebo intravenously on Days 1, 15, 168, and 182. Participants will also receive an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants will also receive acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
Interventions: intervention 1: Rituximab intervention 2: Placebo intervention 3: Prednisone intervention 4: Acetaminophen intervention 5: Diphenhydramine
Intervention descriptions: intervention 1: Rituximab will be supplied as a sterile liquid for IV administration. intervention 2: Placebo will be supplied as a sterile liquid for IV administration. intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT00679055
Conditions: Peripheral Vascular Diseases
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-03-31; Completion date: 2008-08-26
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A 12-Week Efficacy Study in participants with Peripheral Arterial Disease. the primary hypothesis is that MK-0736 7 mg administered once daily for 12 weeks will result in a decrease in lower extremity atherosclerotic plaque macrophage content when compared to placebo (an approximate decrease of up to 30% is expected).

Detailed description:

Arms: arm 1: Participants will be orally administered 7 mg of MK-0736 once daily for 12 weeks arm 2: Participants will be orally administered placebo once daily for 12 weeks.
Interventions: intervention 1: MK-0736 intervention 2: Comparator: placebo (unspecified)
Intervention descriptions: intervention 1: MK-0736; 7mg once daily, orally at approximately the same time each morning for 12 weeks. intervention 2: Matching Placebo once daily, orally at approximately the same time each morning for 12 weeks.

Protocol documents:
Clinical trial NCT00449761
Conditions: Leukemia, Myeloid, Chronic
Keywords: Refractory Chronic Myeloid Leukemia accelerated phase blast phase (blast crisis) adults oral LBH589
Sponsor: Novartis Pharmaceuticals
Start date: 2007-02-23; Completion date: 2008-08-26
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors

Detailed description:
study was designed to assess the hematologic response associated with treatment of oral panobinostat. Hematologic response is defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC). Hematologic responses were to be confirmed after 4 weeks, and all criteria listed below for each type of response were to be concomitantly met to result into a response.

Arms: arm 1: Participants received panobinostat 20 milligrams (mg) orally once daily (OD), three times a week as part of a 4 week (28 day) treatment cycle. Panobinostat was administered at the same time each morning, and with an 8oz/240 milliliter (ml) of water after a fasting period of at least two hours (water was allowed). Participants could continue this treatment until an unacceptable toxicity that precludes further treatment was experienced, or until disease progression.
Interventions: intervention 1: LBH589
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02229825
Conditions: Depressive Disorder, Major
Sponsor: Boehringer Ingelheim
Start date: 2007-02-09; Completion date: 2008-08-26
Enrollment: 339 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study to assess efficacy of Duloxetine 120 mg and Duloxetine 60 mg in patients hospitalized for severe depression after 4 weeks of treatment. To evaluate the rescue option in non-responding patients. Safety of Duloxetine will also be assessed.

Detailed description:

Arms: arm 1: Duloxetine 60 mg arm 2: Duloxetine 120 mg
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Capsule intervention 2: Capsule

Protocol documents:
Clinical trial NCT00215644
Conditions: Esophageal Cancer Gastric Cancer
Keywords: Esophagus Gastric Adenocarcinoma EGFR matuzumab EMD 72000 randomized Epirubicin cisplatin capecitabine Metastatic Esophago-Gastric cancer
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2005-08-31; Completion date: 2008-08-31
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness and safety of experimental treatment matuzumab and ECX chemotherapy, with ECX chemotherapy. Participants invited to take part have metastatic cancer of the esophagus (gullet) or stomach.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Matuzumab intervention 2: Epirubicin intervention 3: Cisplatin intervention 4: Capecitabine
Intervention descriptions: intervention 1: Participants will receive matuzumab 800 milligrams (mg) intravenously (IV) every week, until disease progression (PD), unacceptable toxicity, death, or consent is withdrawn. intervention 2: Participants will receive epirubicin 50 milligrams per square meter (mg/m\^2) on Day 1 of 21-day cycle up to a maximum of 8 cycles. intervention 3: Participants will receive cisplatin 60 mg/m\^2 on Day 1 of 21-day cycle up to a maximum of 8 cycles. intervention 4: Participants will receive capecitabine 1250 mg/m\^2 daily in a 21-day cycles up to a maximum of 8 cycles.

Protocol documents:
Clinical trial NCT00239681
Conditions: Elevated High-sensitivity C-Reactive Protein (hsCRP)
Keywords: Primary prevention Cardiovascular disease Statin therapy C-reactive protein
Sponsor: AstraZeneca
Start date: 2003-02-01; Completion date: 2008-09-01
Enrollment: 17802 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and effectiveness of long-term therapy with rosuvastatin compared with a placebo, and to evaluate whether treatment with rosuvastatin might be effective in reducing the risk of major cardiovascular events.

Detailed description:
AstraZeneca announced it has decided to stop the CRESTOR JUPITER clinical study early based on a recommendation from an Independent Data Monitoring Board and the JUPITER Steering Committee, which met on March 29, 2008. The study will be stopped early because there is unequivocal evidence of a reduction in cardiovascular morbidity and mortality amongst patients who received CRESTOR when compared to placebo.

Arms: arm 1: Rosuvastatin 20 mg once daily arm 2: Placebo once daily
Interventions: intervention 1: Rosuvastatin intervention 2: Placebo
Intervention descriptions: intervention 1: Oral intervention 2: Oral

Protocol documents:
Clinical trial NCT00242710
Conditions: Endometrial Hyperplasia Osteoporosis
Keywords: Endometrium Uterus Menopause
Sponsor: Pfizer
Start date: 2005-09-01; Completion date: 2008-09-01
Enrollment: 1083 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective for the prevention of endometrial hyperplasia and for the prevention of osteoporosis in postmenopausal women.

Detailed description:

Arms: arm 1: BZA 20mg/CE 0.625 arm 2: BZA 20mg/CE 0.45 arm 3: CE 0.45mg/MPA1.5mg arm 4: Placebo
Interventions: intervention 1: Bazedoxifene/Conjugated Estrogen intervention 2: Bazedoxifene/Conjugated Estrogen intervention 3: CE 0.45 mg/MPA 1.5mg intervention 4: Placebo
Intervention descriptions: intervention 1: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 2: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 3: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study. intervention 4: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.

Protocol documents: