ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01433731
Conditions: Lymphoma, T-Cell, Cutaneous
Keywords: CTCL Cutaneous T-Cell Lymphoma
Sponsor: TetraLogic Pharmaceuticals
Start date: 2011-11-01; Completion date: 2013-09-01
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and tolerability of topical SHP141 applied directly to skin lesions in patients with Stage IA, IB, or IIA Cutaneous T-cell Lymphoma. This study will also investigate the effect of SHP141 on skin lesions in patients with Stage IA, IB, or IIA CTCL.

Detailed description:

Arms: arm 1: placebo for SHAPE (SHHP-141) topical gelled solution arm 2: SHAPE (SHP-141) topical gelled solution at 0.1% concentration twice weekly arm 3: SHAPE (SHP-141) topical gelled solution at 0.5% concentration twice weekly arm 4: SHAPE (SHP-141) topical gelled solution at 1.0% concentration twice weekly
Interventions: intervention 1: placebo for SHAPE (SHP-141) intervention 2: SHAPE (SHP-141) 0.1% BID intervention 3: SHAPE (SHP-141) 0.5% BID intervention 4: SHAPE (SHP-141) 1.0% BID
Intervention descriptions: intervention 1: topical gelled solution intervention 2: topical gelled solution intervention 3: topical gelled solution intervention 4: topical gelled solution

Protocol documents:
Clinical trial NCT01436643
Conditions: Depression Relapsing-remitting Multiple Sclerosis
Keywords: Depression Multiple Sclerosis Fingolimod Venlafaxine Fluoxetine
Sponsor: Novartis Pharmaceuticals
Start date: 2011-11-01; Completion date: 2013-09-01
Enrollment: 54 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, multi-center, open-label study in Relapsing-remitting Multiple Sclerosis (RRMS) patients with mild to moderate depression treated with selected serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI) antidepressants over 16 weeks as add-on to fingolimod treatment. It is designed to evaluate the safety and tolerability of this combination in this patient population based on an immunomodulatory treatment with fingolimod.

Detailed description:

Arms: arm 1: Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg arm 2: Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg arm 3: Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
Interventions: intervention 1: Venlafaxine intervention 2: Fluoxetine intervention 3: Citalopram intervention 4: Fingolimod
Intervention descriptions: intervention 1: Venlafaxine starting dose was 75 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 150 Mg intervention 2: Fluoxetine starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg intervention 3: Citalopram starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg intervention 4: Dosage of 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once daily. Fingolimod was supplied in bottles containing 35 capsules each.

Protocol documents:
Clinical trial NCT01439074
Conditions: Burn Injuries
Keywords: Burn injuries Mepilex Ag SSD Ag Partial thickness
Sponsor: Molnlycke Health Care AB
Start date: 2011-09-01; Completion date: 2013-09-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose is to compare time to healing using absorbent foam silver dressing (Mepilex Ag) compared to a silver sulfadiazine (SSD) 1% cream in the treatment of partial thickness burn injuries.284 in-patients in 8-12 centres in China will be evaluated. Treatment period will be up to 4 weeks with either Mepilex Ag or SSD.

Detailed description:
Subjects enrolled in this investigation were in-patients at eleven centers in China. To be included, subjects had to have deep partial-thickness burn injuries. The subjects were consecutively allocated to a subject code providing they fulfilled all inclusion criteria and none of the exclusion criteria and had signed a written informed consent form. Two evaluators independent of each other made the judgment regarding depth of the burn before enrolling a subject. The subjects were randomized to either receive Mepilex Ag or SSD.

Treatment period were up to four weeks with either SSD or Mepilex Ag. Changes of the investigation products were performed according to a standardized schedule, unless the wound healed before.

Arms: arm 1: Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film. arm 2: SSD Ag cream is white cream, 1% SSD Ag, 40g/tube This cream is indicated for prevent and treat secondary wound infection of small area, mild burn/scald.
Interventions: intervention 1: Mepilex Ag intervention 2: Silver Sulphadiazine Ag cream
Intervention descriptions: intervention 1: Dressing intervention 2: A cream used on burnt areas.

Protocol documents:
Clinical trial NCT01444300
Conditions: Multiple Sclerosis Fatigue
Keywords: multiple sclerosis postural balance gait fatigue
Sponsor: Oregon Health and Science University
Start date: 2011-09-01; Completion date: 2013-09-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dalfampridine is a new medication that was FDA approved in 2010 to improve walking speed in people with Multiple Sclerosis (MS). People with MS walk slowly in part because MS damages the myelin insulation around nerves which slows conduction of messages from the brain to the leg muscles. Dalfampridine works by improving conduction in nerves with damaged myelin. Recent research indicates that imbalance in MS is in large part caused by poor conduction by the nerves that transmit information about the position of the legs to the brain. It is therefore likely that, by improving nerve conduction, dalfampridine will also improve imbalance in people with MS. Dalfampridine will be administered in this study by the same route (oral), dosage (10mg), and frequency (every 12 hours) approved by the FDA to improve walking speed in people with MS. The proposed pilot study will examine the effects of dalfampridine on imbalance in 24 subjects with Multiple Sclerosis (MS) and imbalance. This small pilot study will help to show if dalfampridine improves imbalance in MS and will guide the design and implementation of a larger full scale study to definitively determine if dalfampridine improves balance and prevents falls in people with MS.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Dalfampridine intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg, bid, pill taken by mouth for 12 weeks intervention 2: placebo pill, bid for 12 weeks

Protocol documents:
Clinical trial NCT01468077
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-11-01; Completion date: 2013-09-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: Tocilizumab 8 mg/kg infusion of 60 minutes duration every 4 weeks for 6 infusions (up to 24 weeks) arm 2: Tocilizumab 8 mg/kg infusion of 31 minutes duration every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour. If an infusion reaction occurred during any treatment, 1 hour infusions were used for all subsequent infusions
Interventions: intervention 1: Tocilizumab
Intervention descriptions: intervention 1: 8 mg/kg infusion

Protocol documents:
Clinical trial NCT01468584
Conditions: Chronic Hepatitis C
Keywords: Genotype 2
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2011-11-01; Completion date: 2013-09-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MP-424 (generic name:Telaprevir) intervention 2: Ribavirin intervention 3: Peginterferon alfa-2b
Intervention descriptions: intervention 1: 750mg q8h for 12 weeks intervention 2: 400 - 1000 mg/day based on body weight for 24 weeks intervention 3: 1.5mcg/kg/week for 24 weeks

Protocol documents:
Clinical trial NCT01473563
Conditions: Nonsquamous Non-Small Cell Neoplasm of Lung Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer Stage IIIB
Sponsor: Eli Lilly and Company
Start date: 2011-12-01; Completion date: 2013-09-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main purpose for this study is to answer the following research questions:

* Can pemetrexed be administered safely at the participant's home, using the same treatment procedure as in a hospital setting?
* Will the participant be satisfied with home care?
* How might this impact the participant's quality of life?
* What are the required medical resources needed to give pemetrexed in a home setting?

Detailed description:

Arms: arm 1: 500 milligrams per square meter (mg/m\^2) pemetrexed administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Maintenance therapy administered until disease progression or the participant is discontinued for any other reason. The first dose of maintenance therapy will be administered at the hospital; thereafter, therapy will be administered in the home setting by qualified oncology homecare nurses.
Interventions: intervention 1: Pemetrexed
Intervention descriptions: intervention 1: Administered intravenously

Protocol documents:
Clinical trial NCT01483872
Conditions: Infection; Dialysis Catheter
Keywords: salvage infected hemodialysis catheters novel catheter lock solution
Sponsor: University of California, San Diego
Start date: 2012-03-01; Completion date: 2013-09-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim: To conduct a randomized, double-blinded, controlled phase II trial to investigate the use of a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin, in addition to systemic antibiotics, for the treatment of hemodialysis catheter-associated bacteremia via a catheter-salvage strategy.

The investigators plan to randomize 102 patients with hemodialysis catheter-associated bacteremia to one of two treatment arms. All patients will receive systemic antibiotics for treatment of their infection. Additionally, patients randomized to the interventional arm will also receive a catheter lock solution consisting of N-acetylcysteine, tigecycline and heparin for 2 weeks with the aim of salvaging the catheter. The control arm will receive only an anticoagulant solution as a catheter lock which is standard of care - this can be either heparin or citrate (depending on what agent is standard of care for a particular patient). The main outcome of interest is successful treatment which is defined as a resolution of the current episode of bacteremia as well as lack of recurrent bacteremia within 90 days of follow-up.

Detailed description:

Arms: arm 1: A combination of the above three drugs will form the catheter lock solution that will be instilled into the catheter arm 2: Standard anticoagulant (heparin or citrate)
Interventions: intervention 1: NAC/Tigecycline/Heparin combination lock solution intervention 2: Standard anticoagulant (Heparin or Citrate)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01491919
Conditions: Hypertension
Keywords: High Blood Pressure Hypertension Renal Transplantation Kidney Transplantation
Sponsor: Uptal Patel
Start date: 2012-06-01; Completion date: 2013-09-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The drug lisinopril is approved by the U.S. Food and Drug Administration for the treatment of high blood pressure, heart failure, and acute heart attacks in adult patients. In children over 6 years of age, lisinopril is approved for the treatment of high blood pressure. Lisinopril is in a group of medications called angiotensin-converting enzyme inhibitors (ACE). ACE inhibitors such as lisinopril work by decreasing certain chemicals that tighten the blood vessels so blood flows more smoothly and the heart can pump blood more efficiently.

There is some information available about how children with high blood pressure absorb, distribute, metabolize, and eliminate lisinopril (this information about medication processing by the body is called pharmacokinetic data). However, there is no information about how children with high blood pressure who have received a kidney transplant process lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril may help kidney transplants work longer by reducing the activity of chemicals made by cells in kidney transplants that can lead to inflammation and injury. Such benefits have not been found with another group of blood pressure medications called calcium channel blockers, which are the most commonly used medication group to control high blood pressure in children after a kidney transplant. A clinical trial will be conducted in the future to compare which medication group helps kidney transplants in children last longer. To guide the selection of the best dose to test in future studies, investigators in this study will try to determine the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and adolescents (2-17 years of age) who have received a kidney transplant and have high blood pressure.

Detailed description:

Arms: arm 1: Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day arm 2: Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day arm 3: Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
Interventions: intervention 1: Lisinopril
Intervention descriptions: intervention 1: Subjects will be randomized to Low, Medium, or High dose of Lisinopril

Protocol documents:
Clinical trial NCT01499082
Conditions: Type 2 Diabetes Mellitus
Sponsor: Sanofi
Start date: 2011-12-01; Completion date: 2013-09-01
Enrollment: 807 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of change in HbA1c from baseline to endpoint (scheduled month 6) in adult participants with type 2 diabetes mellitus

Secondary Objectives:

* To compare the efficacy of insulin glargine new formulation and Lantus in terms of occurrence of nocturnal Hypoglycemia

Detailed description:
The maximum study duration was up to approximately 58 weeks per participant, consisting of:

* up to 2 week screening period
* 6-month comparative efficacy and safety treatment period
* 6-month comparative safety extension period
* 4-week safety follow-up period in a subset of participants
* a 3-month administration substudy period starting after completion of the 6-month study period for participants willing to in a subset of participants randomized to HOE901-U300

Arms: arm 1: None arm 2: None
Interventions: intervention 1: HOE901-U300 (new formulation of insulin glargine) intervention 2: Lantus (insulin glargine)
Intervention descriptions: intervention 1: HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter \[mg/dL\]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9. intervention 2: Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).

Protocol documents:
Clinical trial NCT01523392
Conditions: Stable Coronary Artery Disease
Keywords: Stable Coronary Artery Disease, CAD
Sponsor: AstraZeneca
Start date: 2012-03-01; Completion date: 2013-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the pharmacodynamic effect of ticagrelor in African American patients with stable coronary artery disease.

Detailed description:
A Randomized, Open-Label, Multiple Dose, Crossover, Multiple Center Study of the Antiplatelet Effects of Ticagrelor versus Clopidogrel in African American Patients with Stable Coronary Artery Disease

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ticagrelor intervention 2: Clopidogrel
Intervention descriptions: intervention 1: Min - 90mg/Max - 180mg tablets (loading dose) intervention 2: 75mg (once daily)/Max - 600mg tablets (loading dose)

Protocol documents:
Clinical trial NCT01525615
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-02-01; Completion date: 2013-09-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5/5 µg; 5/5 µg) with placebo on exercise tolerance after 12 weeks of treatment in patients with COPD.

Detailed description:

Arms: arm 1: once daily 2 puffs, fixed dose combination (FDC) solution for inhalation Respimat arm 2: once daily 2 puffs, FDC solution for inhalation Respimat arm 3: once daily 2 puffs, solution for inhalation Respimat
Interventions: intervention 1: Respimat inhaler intervention 2: tiotropium+olodaterol (low dose) intervention 3: tiotropium + olodaterol (high dose) intervention 4: Respimat inhaler intervention 5: Respimat inhaler intervention 6: placebo to tiotropium+olodaterol
Intervention descriptions: intervention 1: Respimat inhaler intervention 2: 2.5 µg tiotropium + 5 µg olodaterol intervention 3: 5 µg tiotropium + 5 µg olodaterol intervention 4: Respimat inhaler intervention 5: Respimat inhaler intervention 6: comparator

Protocol documents:
Clinical trial NCT01526733
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Continuous Subcutaneous Insulin Infusion (CSII)
Sponsor: Halozyme Therapeutics
Start date: 2011-12-01; Completion date: 2013-09-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate consistency of accelerated insulin absorption and onset-of-action and shortened duration of action for bolus insulin infusions after pretreatment with 150 units (U) of Hylenex® (recombinant human hyaluronidase PH20 \[rHuPH20\]) injection at the time of infusion set insertion compared to sham injection.

Detailed description:

Arms: arm 1: In Phase I or Phase II of the study, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.

Each Phase was separated by a washout period of 5 to 21 days. arm 2: In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of recombinant human hyaluronidase (rHuPH20).

Each Phase was separated by a washout period of 5 to 21 days.
Interventions: intervention 1: Sham Injection intervention 2: Recombinant human hyaluronidase PH20 intervention 3: Insulin aspart intervention 4: Insulin lispro
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01536262
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-02-01; Completion date: 2013-09-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the safety of 52 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).

Detailed description:

Arms: arm 1: Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT arm 2: Olodaterol solution for inhalation - RESPIMAT arm 3: Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT
Interventions: intervention 1: Tiotropium + Olodaterol intervention 2: Respimat intervention 3: Tiotropium + Olodaterol intervention 4: Olodaterol intervention 5: Respimat intervention 6: Respimat
Intervention descriptions: intervention 1: Tiotropium and Olodaterol FDC once daily inhalation intervention 2: Respimat inhaler intervention 3: Tiotropium and Olodaterol FDC once daily inhalation intervention 4: Olodaterol once daily inhalation intervention 5: Respimat inhaler intervention 6: Respimat inhaler

Protocol documents: