ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00377858
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes type 2
Sponsor: Eli Lilly and Company
Start date: 2006-08-01; Completion date: 2008-09-01
Enrollment: 484 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study of patients with type 2 diabetes and inadequate glycemic control on two or more oral antihyperglycemic agents comparing adding insulin lispro mid mixture to the oral antihyperglycemic agents to adding insulin glargine to the oral antihyperglycemic agents.

Detailed description:

Arms: arm 1: Insulin lispro mid mixture (MM) up to three times a day (TID) arm 2: Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
Interventions: intervention 1: Insulin lispro mid mixture (MM) intervention 2: Insulin glargine
Intervention descriptions: intervention 1: Patient specific adjusted dose, three times a day (TID), subcutaneous (SC) injection x 36 weeks intervention 2: Patient specific adjusted dose, every day (QD), subcutaneous (SC) injection x 36 weeks

Protocol documents:
Clinical trial NCT00378573
Conditions: Non-small Cell Lung Cancer
Sponsor: Sanofi
Start date: 2007-01-01; Completion date: 2008-09-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II prospective, multicenter study evaluating Progression Free Survival (PFS) after first line treatment with the combination of gemcitabine, docetaxel, and bevacizumab in subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC). PFS will be measured from the date of registration (ie, assignment of subject number when subject meets all entry criteria) to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurs first.

Detailed description:

Arms: arm 1: Single arm treatment with docetaxel, gemcitabine and bevacizumab
Interventions: intervention 1: docetaxel intervention 2: gemcitabine intervention 3: bevacizumab
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00383240
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 781 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)\[MF/F\] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours \[AUC\](0-12 hours) of the Change From Baseline to the Week 12 Endpoint

in Forced Expiratory Volume in One Second (FEV1) \[Time Frame: Baseline to Week 12\] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID intervention 2: Mometasone furoate MDI (MF MDI) 200 mcg intervention 3: formoterol fumarate 10 mcg intervention 4: Placebo
Intervention descriptions: intervention 1: MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 26 weeks intervention 2: MF 200 mcg via metered dose inhaler twice daily for 26 weeks intervention 3: F via metered dose inhaler 10 mcg twice a day for 26 weeks intervention 4: Placebo metered dose inhaler twice a day for 26 weeks

Protocol documents:
Clinical trial NCT00391079
Conditions: Multiple Sclerosis
Keywords: Central Neuropathic Pain
Sponsor: GW Pharmaceuticals Ltd
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 339 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if cannabis-based medicine compared to a dummy medicine (placebo that contains no active ingredient) can help the central neuropathic pain patients experience as a result of multiple sclerosis. This type of pain "central neuropathic pain" is described as shooting, stabbing, burning or searing like sensation, which is often worse at night.

Detailed description:
GW has shown in phase II and III studies that Sativex has analgesic properties that are effective in relieving neuropathic pain. These studies suggested that Sativex is well tolerated and may also improve sleep and quality of life. GW is conducting this study to further demonstrate these effects.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Sativex intervention 2: Placebo
Intervention descriptions: intervention 1: Containing D9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L.

Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays (THC 32.5 mg: CBD 30 mg. intervention 2: Containing colourants and excipients. Delivered in 100 µl actuations by a pump action oromucosal spray. Maximum dose within any 24-hour interval 12 sprays.

Protocol documents:
Clinical trial NCT00391807
Conditions: Contraception
Keywords: Contraception
Sponsor: Warner Chilcott
Start date: 2006-11-01; Completion date: 2008-09-01
Enrollment: 1683 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a non-comparative study. The primary objective of the study is to assess the efficacy of a low dose oral contraceptive in the prevention of pregnancy. The secondary objectives are to assess the incidence of intracyclic bleeding; and to assess the safety and tolerability of the product.

Detailed description:

Arms: arm 1: Norethindrone/Ethinyl Estradiol
Interventions: intervention 1: Norethindrone acetate/ethinyl estradiol
Intervention descriptions: intervention 1: one tablet per day

Protocol documents:
Clinical trial NCT00391989
Conditions: Lymphoblastic Leukemia, Acute
Keywords: Ph+ Acute Lymphoblastic Leukaemia Dasatinib targeted therapy Patients with Ph positive and or BCR ABL positive ALL
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Start date: 2006-09-01; Completion date: 2008-09-01
Enrollment: 53 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.

Detailed description:
This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.

Interventions: intervention 1: Dasatinib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00398398
Conditions: Gastric Cancer
Keywords: gastric cancer chemotherapy cetuximab capecitabine oxaliplatin
Sponsor: Asan Medical Center
Start date: 2006-11-01; Completion date: 2008-09-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The combination of capecitabine and oxaliplatin as 'backbone' regimen, adding a newer biologic agent, cetuximab, is a reasonable strategy of further chemotherapy development in advanced gastric cancer, which is the investigators study rationale.

Detailed description:
There is presently no chemotherapy regimen considered to be the global standard of care for patients with AGC, and there is still a need for new agents and/or regimens to improve the efficacy and safety of chemotherapy in advanced stomach cancers.

The combination of 5-fluorouracil plus cisplatin (FP) has been widely used for the first-line treatment of advanced gastric cancer in many countries.

Randomized phase III trial investigating capecitabine plus cisplatin(XP) versus FP showed XP is at least as good as FP with improved patients' preference.

A Phase II study of capecitabine plus oxaliplatin (XELOX) was conducted in our study group.

Arms: arm 1: Capecitbine, oxaliplatin and cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.
Interventions: intervention 1: Capecitabine, Oxaliplatin, Cetuximab
Intervention descriptions: intervention 1: Xelox(Capecitbine, Oxaliplatin) and Cetuximab every three week; Capecitabine 1,000 mg/m2 was administered twice daily on days 1-14. Oxaliplatin 130 mg/m2 i.v. for 2 h was given on day 1 after cetuximab infusion. Cetuximab at an initial loading dose of 400 mg/m2 i.v. for 2 h and, thereafter, maintenance dose of 250 mg/m2 for 1 h every week.

Protocol documents:
Clinical trial NCT00402233
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Start date: 2006-11-01; Completion date: 2008-09-01
Enrollment: 312 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary objective: to assess the efficacy of pramipexole given two times daily compared to placebo.

Secondary objectives: to assess the effects of pramipexole on mood, cognition, fatigue, impulse control, daytime sleepiness and nighttime sleep compared to placebo; to compare the tolerability among the treatment groups over 12 weeks

Detailed description:

Arms: arm 1: None arm 2: Pramipexole 0.5 mg tid (three times a day) arm 3: Pramipexole 0.5 mg bid (bis in die (two times a day)) arm 4: Pramipexole 0.75 mg bid (bis in die (two times a day))
Interventions: intervention 1: Pramipexole intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00405652
Conditions: Liver Transplantation
Keywords: Liver transplantation, mycophenolate, GI problems, Quality of Life
Sponsor: Novartis Pharmaceuticals
Start date: 2007-01-01; Completion date: 2008-09-01
Enrollment: 34 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life in liver transplant recipients

Detailed description:

Arms: arm 1: Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
Interventions: intervention 1: Enteric-coated Mycophenolate sodium (EC-MPS)
Intervention descriptions: intervention 1: experimental

Protocol documents:
Clinical trial NCT00419003
Conditions: Major Depression
Sponsor: Baylor College of Medicine
Start date: 2006-12-01; Completion date: 2008-09-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.

Detailed description:
This research proposal will investigate a glutamate-modulating agent, riluzole, in treatment-resistant patients who exhibit an acute, sustained response to a single dose of intravenous (IV) racemic ketamine. Fifty ketamine-responders will be randomized to riluzole or placebo in a 4-week, randomized, double-blind, continuation-phase study.

Arms: arm 1: Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. 300 mg of lamotrigine 2 hrs prior to ketamine infusion. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions. arm 2: 2 hours prior to ketamine infusion each patient received three capsules of placebo identical in size, weight, appearance, and taste to the lamotrigine tablets. Responders were randomized to one of two continuation pharmacotherapy groups, receiving either two capsules of riluzole 50 mg each (100 mg/d) or matching pill placebo under double-blind conditions.
Interventions: intervention 1: Lamotrigine intervention 2: Ketamine intervention 3: Riluzole
Intervention descriptions: intervention 1: anticonvulsant medication intervention 2: subanesthetic dose of NMDAR antagonist intervention 3: glutamate release inhibitor

Protocol documents:
Clinical trial NCT00420303
Conditions: Spondylarthropathies, Enthesitis
Keywords: Refractory Heel Enthesitis in Spondylarthropathy Spondylarthropathy Refractory Heel Enthesitis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-01-01; Completion date: 2008-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of Etanercept in patients with spondylarthropathy and refractory heel enthesitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Etanercept intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg injection once weekly intervention 2: placebo

Protocol documents:
Clinical trial NCT00420342
Conditions: Postmenopause Hypertension Pre-Hypertension
Keywords: Pre-Hypertension in Postmenopausal Women
Sponsor: Bayer
Start date: 2007-01-01; Completion date: 2008-09-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to compare the effects of treatment of two different formulations of Angeliq® and Prempro on blood pressure in post-menopausal women with prehypertension.

Detailed description:
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc. is the sponsor of the trial.

Arms: arm 1: 0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 2: 2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects) arm 3: 1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
Interventions: intervention 1: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 2: Drospirenone/17ß-estradiol (Angeliq, BAY86-4891) intervention 3: SH K 00641 C - Medroxyprogesterone acetate / conjugated equine (Prempro TM)
Intervention descriptions: intervention 1: SH K 00641 A -Active study medication encapsulated tablet intervention 2: SH K 00641 B - Active study medication encapsulated tablet intervention 3: Active control encapsulated tablet

Protocol documents:
Clinical trial NCT00435591
Conditions: Hyponatremia Euvolemia Hypervolemia
Keywords: Hyponatremia Euvolemia Hypervolemia Conivaptan Vaprisol® YM087
Sponsor: Cumberland Pharmaceuticals
Start date: 2007-01-01; Completion date: 2008-09-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the effectiveness and safety of multiple dosing regimens of IV conivaptan in subjects with euvolemic or hypervolemic hyponatremia

Detailed description:

Arms: arm 1: Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule arm 2: Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule arm 3: Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag arm 4: Conivaptan loading dose (20mg) + 20mg/day continuous infusion conivaptan per premix bag
Interventions: intervention 1: Conivaptan intervention 2: placebo
Intervention descriptions: intervention 1: ampoule or premix bag intervention 2: ampoule or premix bag

Protocol documents:
Clinical trial NCT00437320
Conditions: Photoaged Skin
Keywords: PDT Photoaging Galderma
Sponsor: Galderma R&D
Start date: 2007-04-18; Completion date: 2008-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Skin photoaging or skin photodamage were terms used to describe the change in the structure, function and appearance of skin caused by prolonged and repeated exposure to sunlight or other ultraviolet light sources.

The visible effects of skin photodamage were fine lines, skin sagging, skin roughness, liver spots and also the appearance of red patches made up of thin red vessels (called telangiectasia).

More and more people were presenting to doctors with concerns about skin photodamage and the demand for corrective procedures was increasing.

Metvix photodynamic therapy (Metvix PDT) is a procedure currently marketed in several countries in Europe (including the United Kingdom \[UK\] and Spain) and in Australia, for the treatment of benign forms of skin cancer (example, actinic keratosis).

The aim of the study was to assess whether Metvix PDT would be effective in correcting the effects related to photodamage and whether it would be well tolerated.

Detailed description:
Different application times of the study treatment were being investigated.

Arms: arm 1: Participants were topically treated with 160 milligrams per gram (mg/g) Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 1 hour at Baseline, Weeks 4 and 8. The target area was then exposed to red light \[using a large-field light emitting diode (LED) light source: Aktilite 128 lamp\] during 7 to 10 minutes to deliver a total dose of 37 Joules per centimeter square J/cm\^2. The total study duration was 20 weeks. arm 2: Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 2 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks. arm 3: Participants were topically treated with 160 mg/g Metvix cream on one half-face or Metvix vehicle cream on the other half-face for 3 hours at Baseline, Weeks 4 and 8. The target area was then exposed to red light (using a large-field LED light source: Aktilite 128 lamp) during 7 to 10 minutes to deliver a total dose of 37 J/cm\^2. The total study duration was 20 weeks.
Interventions: intervention 1: Metvix Cream 160 mg/g intervention 2: Metvix Vehicle Group
Intervention descriptions: intervention 1: Participants were treated with topical administration of Metvix cream. intervention 2: Participants were treated with topical administration of Metvix Vehicle cream.

Protocol documents:
Clinical trial NCT00460577
Conditions: Acute Bronchial Obstruction, Asthma
Keywords: Asthma, Formoterol, Bronchial Obstruction, Children
Sponsor: Novartis
Start date: 2007-03-01; Completion date: 2008-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide plus Fenoterol in cumulative sequential doses in asthmatic children (5-\<12 years) with acute bronchial obstruction attending emergency services

Detailed description:

Arms: arm 1: Formoterol (Foradil®) 12 micrograms administered through Aerolizer®. arm 2: Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
Interventions: intervention 1: Formoterol fumerate intervention 2: fenoterol/ipratropium bromide
Intervention descriptions: intervention 1: 12 micrograms stat (twice if necessary). Inhaled via aerolizer intervention 2: 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.

Protocol documents:
Clinical trial NCT00464438
Conditions: Bacterial Conjunctivitis
Sponsor: Allergan
Start date: 2007-06-01; Completion date: 2008-09-01
Enrollment: 171 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 7 day study to evaluate the safety and efficacy of topical gatifloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in subjects from birth to 31 days of age

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: gatifloxacin intervention 2: moxifloxacin 0.5% eye drops
Intervention descriptions: intervention 1: Day 1-6 = 1 drop of study medication three times a day intervention 2: Day 1-6 = 1 drop of study medication three times a day

Protocol documents: