ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00396565
Conditions: Schizophrenia
Keywords: Schizophrenia JNS007ER Positive and Negative Syndrome Scale (PANSS) Paliperidone Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2006-07-01; Completion date: 2007-11-01
Enrollment: 394 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness and safety of Extended Release Osmotic Controlled-Release Oral Delivery System (OROS) Paliperidone compared to placebo in patients with Schizophrenia. Olanzapine will be used as a reference drug in the study.

Detailed description:
This is a multicenter, double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), randomized (patients are assigned different treatments based on chance), placebo- and active-controlled, parallel-group study. Patients will be randomized into 1 of 3 treatment groups to receive oral dosages of Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone 6 mg, olanzapine 10 mg, or placebo. They will receive two capsules of Paliperidone ER 3 mg, placebo or Olanzapine 5 mg once daily after breakfast for 6 weeks. The study will include a screening period, followed by double-blind treatment for 6 weeks.

Arms: arm 1: Extended Release (ER) Osmotic Controlled-Release Oral Delivery System (OROS) paliperidone arm 2: None arm 3: None
Interventions: intervention 1: ER OROS paliperidone intervention 2: Placebo intervention 3: Olanzapine
Intervention descriptions: intervention 1: Type= exact number, unit= mg, number= 3, form= tablet, route= oral use. Two tablets once daily for 6 weeks. intervention 2: Form= tablet, route= oral use. Two tablets once daily for 6 weeks. intervention 3: Type= exact number, unit= mg, number= 2.5, form= tablet, route= oral use. Four tablets once daily for 6 weeks.

Protocol documents:
Clinical trial NCT00406783
Conditions: Rhinitis, Allergic, Seasonal Rhinitis, Allergic, Perennial
Keywords: Allergic Rhinitis Intermittent Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2006-08-01; Completion date: 2007-11-01
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the effectiveness of desloratadine in treating subjects with allergic rhinitis (AR) who meet the criteria for intermittent allergic rhinitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 5-mg Desloratadine intervention 2: Placebo
Intervention descriptions: intervention 1: 5-mg Desloratadine tablet, once daily for 15 days intervention 2: Placebo tablet, once daily for 15 days

Protocol documents:
Clinical trial NCT00408876
Conditions: Back Pain Without Radiation
Sponsor: Eli Lilly and Company
Start date: 2006-12-01; Completion date: 2007-11-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition--Whether duloxetine once daily can help patients with Chronic Low Back Pain.

Detailed description:

Arms: arm 1: duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks arm 2: duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks arm 3: duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks arm 4: placebo once a day (QD), by mouth (PO) for 13 weeks
Interventions: intervention 1: Duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00413049
Conditions: Hypertension
Keywords: Hypertension, valsartan, amlodipine, high blood pressure
Sponsor: Novartis
Start date: 2007-01-01; Completion date: 2007-11-01
Enrollment: 698 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Valsartan/amlodipine 80/5 mg intervention 2: Amlodipine 5 mg
Intervention descriptions: intervention 1: 1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures. intervention 2: 1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Protocol documents:
Clinical trial NCT00413413
Conditions: Hypertension
Keywords: Hypertension, valsartan, amlodipine, high blood pressure
Sponsor: Novartis Pharmaceuticals
Start date: 2007-01-01; Completion date: 2007-11-01
Enrollment: 1134 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Valsartan/amlodipine 80/5 mg intervention 2: Valsartan 80 mg intervention 3: Valsartan 160 mg
Intervention descriptions: intervention 1: 1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily intervention 2: 1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily intervention 3: 1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily

Protocol documents:
Clinical trial NCT00420992
Conditions: Osteoarthritis Chronic Pain
Keywords: hip knee pain osteoarthritis OA Kadian Alpharma naltrexone Opioid morphine Embeda ALO-01
Sponsor: Pfizer
Start date: 2006-12-01; Completion date: 2007-11-01
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.

Detailed description:
The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.

Arms: arm 1: Up to 80 mg twice a day (bid) arm 2: Twice a day (bid)
Interventions: intervention 1: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) intervention 2: Placebo
Intervention descriptions: intervention 1: capsules, up to 80 mg bid intervention 2: capsules, bid

Protocol documents:
Clinical trial NCT00424190
Conditions: Bacterial Infections
Keywords: Abscess Antibacterial Antibiotic Antimicrobial Bacterial infection, skin Ceftaroline Ceftaroline acetate Cellulitis Cephalosporin Complicated skin and skin structure infection cSSSI Intravenous Methicillin-resistant Staphylococcus Aureus (MRSA) PPI-0903 Prodrug Skin disease, bacterial Skin infection Staphylococcal skin infection Staphylococcus aureus Streptococcal skin infection Surgical site infection TAK-599
Sponsor: Forest Laboratories
Start date: 2007-02-01; Completion date: 2007-11-01
Enrollment: 698 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

Detailed description:
Additional purpose of the study is to compare ceftaroline effectivity versus Vancomycin plus Aztreonam in the treatment of complicated skin infections in adults.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: IV Vancomycin plus IV Aztreonam intervention 2: Ceftaroline
Intervention descriptions: intervention 1: vancomycin at 1 g parenteral infused over 60 minutes followed by aztreonam 1 g infused over 60 minutes, every 12 hours, for 5 to 14 days. intervention 2: 600 mg parenteral infused over 60 minutes, every 12 hours for 5 to 14 days

Protocol documents:
Clinical trial NCT00437645
Conditions: Essential Hypertension
Keywords: Essential hypertension blood pressure edema valsartan amlodipine combination treatment
Sponsor: Novartis Pharmaceuticals
Start date: 2007-01-01; Completion date: 2007-11-01
Enrollment: 1183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to compare the efficacy, tolerability, and safety of the combination valsartan/amlodipine 160/5 mg versus amlodipine 10 mg in patients with essential hypertension not adequately controlled (defined as mean sitting systolic blood pressure \[msSBP\] ≥ 130 mmHg and ≤ 160 mmHg) on amlodipine 5 mg alone. The study evaluated both the efficacy and tolerability of the treatments by providing data that assessed blood pressure and the proportion of patients developing peripheral edema.

Detailed description:

Arms: arm 1: Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator. arm 2: Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
Interventions: intervention 1: Valsartan 160 mg capsules intervention 2: Amlodipine 5 mg capsules intervention 3: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: capsules

Protocol documents:
Clinical trial NCT00438360
Conditions: Chronic Plaque Psoriasis
Keywords: Cyclosporine, chronic plaque psoriasis, intermittent therapy
Sponsor: Novartis Pharmaceuticals
Start date: 2006-05-01; Completion date: 2007-11-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the efficacy of cyclosporine at 2, 5 mg/kg/day bid (i.e. bis in a day), when administered twice a week compared to continuous administration, in patients with chronic plaque psoriasis.

Detailed description:

Arms: arm 1: Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations arm 2: Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations
Interventions: intervention 1: Cyclosporine A microemulsion intervention 2: Placebo
Intervention descriptions: intervention 1: Oral soft gelatin capsules of Cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations intervention 2: Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations

Protocol documents:
Clinical trial NCT00440401
Conditions: Haemorrhage Haemostasis Cardiovascular Surgery
Keywords: Surgical treatment of haemorrhage
Sponsor: Nycomed
Start date: 2007-02-01; Completion date: 2007-11-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To demonstrate efficacy and safety of TachoSil® in cardiovascular surgery

Detailed description:

Arms: arm 1: None arm 2: Standard Treatment of haemorrhage in cardiovascular surgery
Interventions: intervention 1: fibrinogen (human) + thrombin (human) intervention 2: Standard haemostatic treatment in cardiovascular surgery
Intervention descriptions: intervention 1: None intervention 2: Any haemostatic fleece material without additional active coagulation stimulating compounds (primarily Surgicel®)

Protocol documents:
Clinical trial NCT00441064
Conditions: Hypertension
Keywords: High blood pressure, hypertension, aliskiren, low sodium diet
Sponsor: Novartis
Start date: 2007-01-01; Completion date: 2007-11-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.

Detailed description:

Arms: arm 1: Patients on low sodium diet ( \<= 100 mmol/day) for the first 4 weeks and high sodium (\>= 200 mmol/day) diet for the next 4 weeks. \[with Aliskiren 300 mg\] arm 2: Patients on high sodium (\>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( \<= 100 mmol/day) for the next 4 weeks. \[with Aliskiren 300 mg\]
Interventions: intervention 1: Aliskiren
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00462904
Conditions: Burns
Sponsor: University of Texas Southwestern Medical Center
Start date: 2006-04-01; Completion date: 2007-11-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety of a protein called BPI that is naturally made by the body's white blood cells to fight infection.

Detailed description:
This study will initially evaluate an FDA approved investigational dosage and will measure the blood levels over time while BPI is being infused through a vein to see if the dose is potentially enough to obtain the desired effect. The drug will be started within 8 hours of burn injury and continued for 48 hours. Patients will be followed on admission and through infusion in the Burn ICU where they will be monitored by ICU standards. They will be seen regularly thereafter on post-burn days 1, 2, 3, 4, 7, 14 and 28 days while in the hospital. If the patient is discharged prior to the 28 day evaluation, they will be evaluated on or around the 28th day in the burn clinic. A blood sample will be obtained to look for potential genetic markers that may increase a burn patients' risk to develop infection in the post burn period.

Arms: arm 1: BPI will be infused by bolus for 30 minutes followed by continuous infusion for 47.5 hours
Interventions: intervention 1: BPI
Intervention descriptions: intervention 1: BPI will be give IV with an initial bolus given over 30 minutes and then a continuous infusion for the next 47.5 hours

Protocol documents:
Clinical trial NCT00463801
Conditions: Staphylococcal Skin Infections
Keywords: Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis Complicated skin and skin-structure infections
Sponsor: Novartis
Start date: 2007-01-01; Completion date: 2007-11-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults

Detailed description:

Arms: arm 1: 350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
Interventions: intervention 1: Daptomycin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00466193
Conditions: Insomnia
Keywords: Insomnia
Sponsor: Transcept Pharmaceuticals
Start date: 2007-05-01; Completion date: 2007-11-01
Enrollment: 295 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate sleep onset following administration of zolpidem tartrate sublingual tablet (Intermezzo) versus placebo in adult insomnia patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: zolpidem tartrate sublingual tablet intervention 2: Placebo
Intervention descriptions: intervention 1: 3.5 milligram zolpidem tartrate sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 2: Placebo sublingual tablet taken as needed following a middle-of-the-night awakening over the 28-night study period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.

Protocol documents:
Clinical trial NCT00502775
Conditions: Rhinitis, Allergic, Seasonal
Keywords: ragweed once daily fexofenadine fluticasone furoate allergic rhinitis
Sponsor: GlaxoSmithKline
Start date: 2007-08-01; Completion date: 2007-11-01
Enrollment: 680 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Detailed description:

Interventions: intervention 1: fluticasone furoate, fexofenadine
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00505518
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Telepsychiatry Chinese American Nursing Home
Sponsor: Massachusetts General Hospital
Start date: 2006-09-01; Completion date: 2007-11-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current use of telepsychiatry, or psychiatric care using videoconferencing, is very limited. The present study investigates the use of this method with a depressed Chinese American population in a nursing home. It is believed that this population can benefit from telepsychiatric treatment when used in collaboration with the primary care they receive in the nursing home.

Detailed description:
Individuals at the South Cove Manor nursing home will be referred to this study if they are experiencing depression. After meeting with the Principal Investigator (a psychiatrist), he will collaborate with the primary care physician and the nursing home staff to establish a treatment plan for the patient. Videoconferencing will be used by the P.I. for regular psychiatric visits with the patient as well as meetings with the nursing home staff to coordinate care for the patient. After collaboration between the two groups, treatment suggestions will be given to the patient's primary care physician (PCP) to implement in the primary care setting. The patient's symptomology, mood, satisfaction of life and side effects of medication will be recorded regularly to measure the effects of treatment for analysis.

Interventions: intervention 1: Psychotropic medication (at discretion of psychiatrist) intervention 2: Collaborative psychiatric and primary medical care
Intervention descriptions: intervention 1: Antidepressant medication, prescribed at discretion of psychiatrist intervention 2: Regular care visits from health workers

Protocol documents:
Clinical trial NCT00519376
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: pharmacodynamics, Chronic Obstructive Pulmonary Disease (COPD) safety, COPD patients pharmacokinetics, tolerability, GW642444,
Sponsor: GlaxoSmithKline
Start date: 2007-08-01; Completion date: 2007-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will involve the use of a new compound, GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. When a medicine is made into a form ready to be given to patients, the active ingredient is often prepared in the form of a salt, and inactive ingredients (excipients) are often added. Inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. In previous studies the study drug has been given as a dry powder in the form of either the 'H' salt (with the excipient lactose), or in the form of the 'M' salt (with the excipients lactose and cellobiose octaacetate). In this study the 'M' salt form of the study drug has been prepared with lactose and a new excipient called magnesium stearate (instead of cellobiose octaacetate). Participants in this study will receive both the 'H' salt (GW642444H) and the new 'M' salt (GW642444M) containing magnesium stearate. This study will be the first time the new 'M' salt form of the study drug will be given to COPD patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: GW642444M intervention 2: GW642444H intervention 3: placebo
Intervention descriptions: intervention 1: drug intervention 2: drug intervention 3: None

Protocol documents:
Clinical trial NCT00519636
Conditions: Rhinitis, Allergic, Perennial
Keywords: experience GW685698X fluticasone furoate preference seasonal allergic rhinitis fluticasone propionate
Sponsor: GlaxoSmithKline
Start date: 2007-08-01; Completion date: 2007-11-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.

Detailed description:
A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105927)

Arms: arm 1: fluticasone furoate nasal spray, fluticasone propionate nasal spray arm 2: fluticasone propionate nasal spray, fluticasone furoate nasal spray arm 3: placebo nasal spray matching fluticasone furoate nasal spray, placebo nasal spray matching fluticasone propionate nasal spray arm 4: placebo nasal spray matching fluticasone propionate nasal spray, placebo nasal spray matching fluticasone furoate nasal spray
Interventions: intervention 1: FPNS intervention 2: FFNS intervention 3: placebo FFNS intervention 4: placebo FPNS
Intervention descriptions: intervention 1: fluticasone propionate nasal spray intervention 2: fluticasone furoate nasal spray intervention 3: placebo nasal spray matching fluticasone furoate nasal spray intervention 4: placebo nasal spray matching fluticasone propionate nasal spray

Protocol documents: