ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00147199
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Arterial Hypertension
Sponsor: United Therapeutics
Start date: 2005-06-01; Completion date: 2007-10-01
Enrollment: 235 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a double-blind placebo-controlled clinical investigation into the efficacy and tolerability of inhaled treprostinil in patients with severe pulmonary arterial hypertension. The primary outcome is the change in 6-minute walk distance from baseline to week 12.

Detailed description:
Patients who have been on a stable dose of 125 mg twice daily (bid) of bosentan or any stable dose of sildenafil for at least three months prior to study start were randomized to either treprostinil inhalation solution or matching placebo.

Administration of study medication was performed by inhalation with the OPTINEB™ ultrasonic nebulizer.

The proposed dosing regimen was four times daily-upon awakening, at midday, evening (dinner time) and bedtime.

After a patient has completed the twelve-week study period, they were given the option of enrolling into an open-label extension study.

Arms: arm 1: 0.9 mg/mL treprostinil for inhalation supplied in 2.9mL ampoules for use in ultra sonic nebulizer arm 2: Placebo inhalation solution for use in ultrasonic nebulizer
Interventions: intervention 1: Inhaled treprostinil intervention 2: Placebo inhalation solution
Intervention descriptions: intervention 1: Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil. intervention 2: Doses are titrated to 9 breaths four times daily.

Protocol documents:
Clinical trial NCT00156065
Conditions: Schizophrenia
Sponsor: Organon and Co
Start date: 2005-09-01; Completion date: 2007-10-01
Enrollment: 187 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

The clinical development of asenapine, as described in the 2007 IDB appears to have antipsychotic activity with superior symptomatic control compared to placebo and an improved safety profile compared to currently available neuroleptics. Its fast dissolving formulation may further add to treatment compliance. While various titration schedules have been used in previous studies, dose increases at 5 mg BID (twice daily) up to 10 mg BID have been well tolerated. Therefore, further exploration in a larger group of subjects with acute exacerbation of schizophrenia using an asenapine flexible dosing design ( 5 or 10 mg BID) will mimic actual clinical practice in a long-term 52-week extension trial.

Detailed description:

Arms: arm 1: Haloperidol in original study (NCT00156104) and in current long-term extension. arm 2: Asenapine in original study and asenapine in current long-term extension. arm 3: Double-Blind subjects randomized to only placebo medication for 6 weeks in the short-term 041023 asenapine trial, were randomized (double-blind) into the long-term 041513 asenapine extension trial and received asenapine 5 mg BID for Week 1. After Week 1, subjects received asenapine (either 5 mg BID or 10 mg BID) for the remainder of the 52-week trial.
Interventions: intervention 1: Haloperidol intervention 2: Asenapine intervention 3: Asenapine
Intervention descriptions: intervention 1: 2-8 mg BID intervention 2: 5 or 10 mg BID intervention 3: 5 or 10 mg BID

Protocol documents:
Clinical trial NCT00166504
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2005-10-01; Completion date: 2007-10-01
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in Korea. The primary hypothesis being tested is that daily administration of Vytorin will result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration from baseline after 6 weeks treatment compared to atorvastatin.

Detailed description:

Arms: arm 1: Ezetimibe 10 mg/Simvastatin 20 mg arm 2: Atorvastatin 10 mg
Interventions: intervention 1: ezetimibe (+) simvastatin intervention 2: atorvastatin
Intervention descriptions: intervention 1: simvastatin/ezetimibe 10/20 mg intervention 2: atorvastatin 10 mg

Protocol documents:
Clinical trial NCT00171054
Conditions: Hypertension
Keywords: hypertension postmenopausal valsartan amlodipine hydrochlorothiazide
Sponsor: Novartis
Start date: 2003-09-01; Completion date: 2007-10-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is compare treatment with valsartan with the possible addition of a diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment on the stiffness of the blood vessels will be studied.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Valsartan 320 mg intervention 2: Amlodipine 10 mg intervention 3: Hydrochlorothiazide
Intervention descriptions: intervention 1: Patients received 160 mg valsartan for 4 weeks. Patients were then up-titrated to receive either 320 mg valsartan for the following 8 weeks. intervention 2: Patients received 5 mg amlodipine for four weeks. Patients were then up-titrated to receive 10 mg amlodipine for the following 8 weeks. intervention 3: At Week 12, patients who did not meet target Blood Pressure for both Systolic Blood Pressure \< 140 mmHg and Diastolic Blood Pressure \< 90 mmHg were eligible to receive 12.5 mg open-label Hydrochlorothiazide for the following 26 weeks.

Protocol documents:
Clinical trial NCT00195429
Conditions: Kidney Failure Graft vs Host Disease
Keywords: Kidney Transplant
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2005-08-01; Completion date: 2007-10-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tacrolimus intervention 2: Sirolimus intervention 3: prednisone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00266227
Conditions: Rheumatoid Arthritis
Sponsor: Genentech, Inc.
Start date: 2006-01-01; Completion date: 2007-10-01
Enrollment: 559 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy of retreatment with rituximab in subjects with active rheumatoid arthritis (RA) who are receiving Methotrexate (MTX).

Detailed description:

Arms: arm 1: 1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate. arm 2: 1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
Interventions: intervention 1: placebo intervention 2: rituximab intervention 3: methotrexate intervention 4: folate
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Oral or parenteral repeating dose intervention 4: Intravenous repeating dose

Protocol documents:
Clinical trial NCT00284739
Conditions: Abdominal Abscess Pelvic Abscess
Sponsor: Kaiser Permanente
Start date: 2006-02-01; Completion date: 2007-10-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.

Detailed description:
The use of fibrinolytics for the percutaneous drainage of loculated pleural effusions has been shown to reduce the catheter dwell time and to improve drainage of the effusions. Abscesses in the abdomen and pelvis are often loculated which makes percutaneous drainage difficult. We hypothesize that the infusion of alteplase via a drainage catheter into the loculated abscess collections of the abdomen and pelvis will similarly decrease catheter dwell time and improve overall abscess drainage. The direct injection of Activase into abscess cavities utilizes a very low dose of drug within a closed environment which should not be associated with any significant risk of hemorrhage. To date, there does not appear to be a significant risk of systemic hemorrhagic complications associated with the use of intracavitary thrombolytics for the drainage of abdominopelvic abscesses although only a few such studies have been reported. We hope to prove that the use alteplase for intracavitary thrombolysis improves outcomes associated with percutaneous catheter drainage of loculated abscess collections without increasing complications or costs.

The design of the trial will be as a single-center, prospective, open-label, randomized trial comparing the infusion of Activase versus saline for treatment of loculated abdominopelvic abscesses requiring percutaneous drainage. Patients with loculated abdominopelvic abscesses who are referred for percutaneous drainage will be eligible for this study. Patients will undergo standard placement of a 10-12 french percutaneous drain into their abscess cavity under computed tomography guidance. If the entire contents of the abscess cavity cannot be aspirated at the time of initial catheter placement, the abscess will be assumed to be loculated. The patient will then be randomized to have their abscess catheter irrigated twice a day with a volume of fluid approximately equal to the one-half the residual volume of the abscess. In the control group, the normal saline will be fluid instilled into the abscess cavity. The study group will receive Activase reconstituted in sterile water and then diluted to the appropriate volume with normal saline.

Arms: arm 1: Multiple Alteplase injection into the abscess collection to improve percutaneous drainage arm 2: Multiple normal saline injection into the abscess collection to improve percutaneous drainage
Interventions: intervention 1: Alteplase intervention 2: saline
Intervention descriptions: intervention 1: 2mg or 4mg given twice daily for three days into loculated abscess intervention 2: saline injection twice daily for three days

Protocol documents:
Clinical trial NCT00296491
Conditions: Asthma
Keywords: Allergic Rhinitis Asthma
Sponsor: GlaxoSmithKline
Start date: 2005-09-01; Completion date: 2007-10-01
Enrollment: 725 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will last up to 6 weeks. Subjects will visit the clinic up to 5 times. Certain clinic visits will include a physical examination, medical history review, and lung function tests. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.

Detailed description:
A Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID

Arms: arm 1: Fluticasone propionate/salmeterol DISKUS combination product (FSC) twice daily (BID) plus vehicle placebo nasal spray once daily (QD) plus montelukast capsule 10mg (MON) QD arm 2: FSC BID plus vehicle placebo nasal spray QD plus placebo capsule QD arm 3: Fluticasone propionate/salmeterol DISKUS combination product (FSC)100/50mcg BID plus fluticasone propionate aqueous nasal spray 200mcg (FPANS) QD plus placebo capsule QD arm 4: Placebo DISKUS BID plus vehicle placebo nasal spray QD plus MON QD
Interventions: intervention 1: fluticasone propionate/salmeterol (FSC) intervention 2: montelukast (MON) intervention 3: fluticasone propionate (FP) intervention 4: placebo nasal intervention 5: ADVAIR DISKUS intervention 6: placebo capsule intervention 7: placebo DISKUS
Intervention descriptions: intervention 1: fluticasone propionate/salmeterol DISKUS combination intervention 2: montelukast capsule intervention 3: fluticasone propionate aqueous nasal spray intervention 4: vehicle placebo nasal spray intervention 5: ADVAIR DISKUS intervention 6: placebo capsule intervention 7: placebo DISKUS

Protocol documents:
Clinical trial NCT00298610
Conditions: Malaria
Keywords: Uncomplicated Malaria GMP artesunate
Sponsor: U.S. Army Medical Research and Development Command
Start date: 2006-03-01; Completion date: 2007-10-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how GMP IV Artesunate is metabolized and cleared by individuals with uncomplicated malaria infection and to determine how fast it eliminates malaria infection from the body.

Detailed description:
This is an unblinded non-randomized phase II pharmacokinetic study of a new GMP formulation of intravenous artesunate. Artesunate has been used throughout Asia and Africa for many years. Its overall efficacy associated with the ability to lower parasitemia is well established. To date, pharmacokinetic studies have not been done in Africa using GMP (Good Manufacturing Practices)-produced drug. The objective of this study is to show that GMP IV artesunate rapidly clears parasites in Adult Kenyan populations with malaria and that the pharmacokinetic profile of the drug approximates other populations of adults tested (Asians and North Americans).

Arms: arm 1: Subject are given intravenous Artesunate once a day for 3 days. Following completion of Artesunate treatment, all subjects received Malarone follow-on therapy to ensure parasitologic cure.
Interventions: intervention 1: Artesunate intervention 2: Malarone
Intervention descriptions: intervention 1: Intravenous Artesunate (2.4 mg/kg) once a day for three days intervention 2: (proguanil/atovaquone) follow-on therapy (4 tablets once daily for three days)

Protocol documents:
Clinical trial NCT00322621
Conditions: Diabetic Neuropathies
Sponsor: Eli Lilly and Company
Start date: 2006-04-01; Completion date: 2007-10-01
Enrollment: 216 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

Detailed description:

Arms: arm 1: All subjects receive 30 mg once daily (QD), by mouth (per os - PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Patients beginning maintenance at the 60 mg QD dose could be increased to the 120 mg QD level if they did not maintain appropriate level of response throughout the maintenance period.
Interventions: intervention 1: Duloxetine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00336505
Conditions: Pneumonia
Keywords: Pneumonia Respiratory Infection Infectious Advanced Life Sciences Lung Pulmonary Cethromycin Restanza Clarithromycin Biaxin
Sponsor: Advanced Life Sciences, Inc.
Start date: 2005-12-01; Completion date: 2007-10-01
Enrollment: 584 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of cethromycin to clarithromycin for the treatment of mild to moderate community-acquired pneumonia (CAP).

Detailed description:
Lower respiratory tract infections remain one of the leading causes of death worldwide. Increasing rates of antibiotic resistance and newer, more pervasive pneumonia-causative pathogens contribute to this statistic. Currently available macrolide antibiotics for the treatment of community-acquired pneumonia are slowly losing effectiveness, resulting in the need to develop newer drugs to fight resistant infections. In this study, we compare the safety and efficacy of a common macrolide, clarithromycin, to a new ketolide, cethromycin.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Cethromycin intervention 2: Clarithromycin
Intervention descriptions: intervention 1: Cethromycin 300 mg once per day (QD) for 7 days, administered orally intervention 2: Clarithromycin 250 mg twice per day (BID) for 7 days, administered orally

Protocol documents:
Clinical trial NCT00372697
Conditions: Acromegaly
Keywords: acromegaly octreotide acetate partial responder patients
Sponsor: Novartis Pharmaceuticals
Start date: 2005-12-01; Completion date: 2007-10-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of an increased frequency of octreotide acetate injections or an increase in dose in partially responsive acromegalic patients with persistently uncontrolled disease.

Detailed description:

Arms: arm 1: Patients received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor. arm 2: Patients received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
Interventions: intervention 1: Octreotide acetate 30 mg suspension
Intervention descriptions: intervention 1: Each vial of study medication contained octreotide acetate 30 mg in a microencapsulated biodegradable polymer, poly (DL-lactide-co-glycolide) (D-(+)glucose), with 17% w/w mannitol in an approximate octreotide:polymer ratio of 1:20. The vehicle contained 0.5% sodium carboxymethylcellulose.

Protocol documents:
Clinical trial NCT00373490
Conditions: Tumors
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-07-01; Completion date: 2007-10-01
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.

Detailed description:

Arms: arm 1: 600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest. arm 2: 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
Interventions: intervention 1: Vorinostat intervention 2: Vorinostat
Intervention descriptions: intervention 1: 600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest. intervention 2: 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.

Protocol documents:
Clinical trial NCT00383019
Conditions: Glaucoma Ocular Hypertension
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2006-11-14; Completion date: 2007-10-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine the efficacy and safety of Xalacom comparing with those of Xalatan in Japanese patients with POAG or OH, in order to show superiority of Xalacom over Xalatan in efficacy and similarity of safety between Xalacom and Xalatan.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Xalatan intervention 2: Xalacom
Intervention descriptions: intervention 1: latanoprost 0.005%, one rop once daily in evening intervention 2: latanoprost 0.005% adn timolol 0.5%, one drop, once daily

Protocol documents: