ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00856973
Conditions: Insomnia Attention Deficit Hyperactivity Disorder
Keywords: Hypnotic Eszopiclone Attention Deficit/Hyperactivity Disorder Insomnia Children Adolescent Polysomnography Actigraphy
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2009-05-01; Completion date: 2011-07-01
Enrollment: 486 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multi center, randomized study to evaluate the efficacy and safety of eszopiclone compared to placebo in children (6-11 years of age, inclusive) and adolescents (12-17 years of age, inclusive) with attention deficit/hyperactivity disorder (ADHD) associated insomnia.

Detailed description:
This is a multi center, randomized, double blind, placebo controlled, fixed dose study of eszopiclone in pediatric subjects 6-17 years of age, inclusive, with ADHD associated insomnia. Subjects will be randomized at approximately 1:1:1 to either low dose oral eszopiclone (1 mg for children ages 6-11 years, 2 mg for adolescents ages 12-17 years), high dose oral eszopiclone (2 mg for children ages 6-11 years, 3 mg for adolescents ages 12-17 years) or placebo. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms: arm 1: 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years arm 2: 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years arm 3: Placebo 6-17 years
Interventions: intervention 1: eszopiclone intervention 2: eszopiclone intervention 3: Placebo
Intervention descriptions: intervention 1: 1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years intervention 2: 2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years intervention 3: 1 tablet per day for 12 weeks

Protocol documents:
Clinical trial NCT00863317
Conditions: Bronchiolitis
Keywords: Bronchiolitis montelukast leukotriene inhibitor
Sponsor: Medical College of Wisconsin
Start date: 2008-12-01; Completion date: 2011-07-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.

Detailed description:

Arms: arm 1: 4mg granules PO QD for 14 days arm 2: Sucrose granules PO QD for 14 days
Interventions: intervention 1: montelukast sodium intervention 2: sucrose
Intervention descriptions: intervention 1: 4mg granules daily for 14 days intervention 2: table sugar as placebo daily for 14 days

Protocol documents:
Clinical trial NCT00884585
Conditions: Atopic Conjunctivitis
Sponsor: Allergan
Start date: 2009-05-01; Completion date: 2011-07-01
Enrollment: 176 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluates the efficacy and safety of Cyclosporine 0.010% eye drops in the treatment of Atopic Keratoconjunctivitis (chronic and severe inflammation of the eye). The study consists of a double-masked phase, and open-labeled phase, and an open-labeled maintenance phase. For the first 3 months of the study, patients will receive either masked Cyclosporine 0.010% eye drops or vehicle four times daily; for the next 6 months, patients may receive open-labeled Cyclosporine 0.010% eye drops four times daily. At month 9, patients who are in remission, will be re-randomized to receive either open-labeled Cyclosporine 0.010% eye drops four times daily or twice daily.

Detailed description:

Arms: arm 1: Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day. arm 2: Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
Interventions: intervention 1: Cyclosporine Vehicle intervention 2: Cyclosporine 0.010%
Intervention descriptions: intervention 1: Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months. intervention 2: Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.

Protocol documents:
Clinical trial NCT00887978
Conditions: Pulmonary Hypertension
Sponsor: United Therapeutics
Start date: 2009-06-01; Completion date: 2011-07-01
Enrollment: 310 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.

Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).

Detailed description:

Arms: arm 1: Identical placebo tablets to UT-15C, doses were titrated in the same manner arm 2: Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
Interventions: intervention 1: UT-15C SR intervention 2: Placebo
Intervention descriptions: intervention 1: treprostinil diolamine sustained release tablets intervention 2: None

Protocol documents:
Clinical trial NCT00910845
Conditions: Overactive Bladder
Sponsor: Allergan
Start date: 2009-09-01; Completion date: 2011-07-01
Enrollment: 557 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A (onabotulinumtoxinA) in treating patients with idiopathic overactive bladder with urinary incontinence.

Detailed description:

Arms: arm 1: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). arm 2: Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
Interventions: intervention 1: onabotulinumtoxinA intervention 2: normal saline
Intervention descriptions: intervention 1: OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable). Or, if placebo is administered at Day 1, onabotulinumtoxinA 100 U injected after a minimum of 12 weeks (if applicable). intervention 2: Normal saline (placebo) injected into the detrusor at Day 1.

Protocol documents:
Clinical trial NCT00913263
Conditions: Prostate Cancer
Keywords: Prostate cancer
Sponsor: Lidds AB
Start date: 2009-06-01; Completion date: 2011-07-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective was to evaluate efficacy of a single dose of Liproca Depot in patients with localized prostate cancer. Primary efficacy variable was the proportion of patients showing PSA nadir. 24 Caucasian men, with a mean age at inclusion of 68.4 years, with localized prostate cancer were injected once with a ready made paste including 600 mg 2-hydroxyflutamide (Liproca Depot) into the site of the prostate where the tumour was localized. The patient was monitored for prostate-specific antigen (PSA) for maximum 6 months or to progression within this time period. The primary endpoint showed interesting results with high success rate (83%), i.e. proportion of patients (Responders) that reached plasma PSA nadir.

Detailed description:
Patients with localized prostate cancer were followed to progression or maximum 24 weeks after a single injection in one lobe of 2-8 mL ready-made paste (corresponding to 400-1600 mg 2-Hydroxyflutamid). Progression was defined as an increase in PSA by \> 25% over baseline or on-treatment nadir.Among the 24 patients the primary endpoint, plasma PSA nadir, was reached by 20 patients (Responders). Efficacy was measured primarily as PSA nadir, and secondly as time to PSA nadir and prostate volume change. Safety was monitored throughout the whole study period.

Arms: arm 1: Single injection of 2-Hydroxyflutamide (2-8mL ready-made paste)in one prostate lobe
Interventions: intervention 1: 2-hydroxyflutamide (2-HOF) [Liproca Depot] intervention 2: 2-Hydroxyflutamide
Intervention descriptions: intervention 1: Ready made paste including 600 mg 2-HOF for injection as a single dose intervention 2: The Product consists of two sterile components, one aqueous liquid and a dry powder, containing the active drug 2-Hydroxyflutamide (2-HOF. The two components were mixed under aceptic conditions to a paste prior to administration.

Protocol documents:
Clinical trial NCT00925782
Conditions: Multiple Myeloma
Keywords: autologous stem cell transplantation
Sponsor: Acrotech Biopharma Inc.
Start date: 2010-01-01; Completion date: 2011-07-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To assess and compare the pharmacokinetics of Melphalan HCL for Injection (Propylene Glycol-Free) versus Alkeran for Injection in multiple myeloma (MM) patients undergoing autologous stem cell transplant (ASCT).

Detailed description:
This study will be a multicenter, open-label, randomized, comparative, cross-over study of high-dose Melphalan HCl for Injection (Propylene Glycol-Free) and Alkeran for Injection conducted in 24 patients who have symptomatic MM and qualify for ASCT.

During the Study Period, patients will be randomized to receive 100mg/m2 of either Melphalan HCl for Injection (Propylene Glycol-Free) or Alkeran for Injection on Day -3 and the alternate drug product on Day -2. Blood samples for pharmacokinetic (PK) evaluation will be withdrawn through an indwelling i.v. cannula each day of melphalan dosing (Day -3 and Day -2).

Following one day of rest after the myeloablative conditioning (Day -1), patients will receive an autologous graft.

Arms: arm 1: Subjects begin with treatment Melphalan and crossover to treatment Alkeran arm 2: Subjects begin with treatment Alkeran and crossover to treatment Melphalan.
Interventions: intervention 1: Melphalan HCL for Injection (Propylene Glycol-Free)/Alkeran for Injection intervention 2: Alkeran for Injection/Melphalan HCL for Injection (Propylene Glycol-Free)
Intervention descriptions: intervention 1: Patients will be randomized to receive 100 mg/m2 of Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and Alkeran for Injection on Day -2 prior to ASCT. intervention 2: Patients will be randomized to receive 100 mg/m2 of Alkeran for Injection on Day -3 and Melphalan HCL for Injection (Propylene Glycol-Free)on Day -2 prior to ASCT.

Protocol documents:
Clinical trial NCT00935532
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes; exenatide once weekly; Byetta; glargine; Lantus; Amylin; Lilly
Sponsor: AstraZeneca
Start date: 2009-07-01; Completion date: 2011-07-01
Enrollment: 427 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objectives of this clinical trial are to compare the effects of exenatide once weekly and insulin glargine on blood glucose control, body weight, lipids, safety, and tolerability.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide once weekly intervention 2: insulin glargine
Intervention descriptions: intervention 1: subcutaneous injection, 2.0mg, once a week; intervention 2: subcutaneous injection, titrated to achieve fasting serum glucose target, once a day

Protocol documents:
Clinical trial NCT00941889
Conditions: HIV Positive Anal Condylomata Anal Warts HIV Infections
Keywords: HIV HPV Anal condylomata Vaccine HIV positive patients Anal condylomata or anal warts
Sponsor: Washington University School of Medicine
Start date: 2007-07-01; Completion date: 2011-07-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.

Detailed description:
A quadrivalent human papilloma virus (HPV) vaccine called Gardasil had recently (at start of study) been developed and approved by the FDA for the prevention of cervical HPV infection and cervical cancer, which is associated with infection from this virus. It is unknown whether the same vaccine could also be of benefit in treating anogenital warts, which are caused by the same virus. This is an important and clinically relevant question which needs to be answered. Anal warts have a high prevalence and recurrence and usually require extended lengths of treatment and follow-up, especially in the HIV population. At times, treatment of anal warts requires multiple surgeries to excise them if the burden of disease is high. Therefore, this disease represents a significant expense to patients and the health care system.

Further, the HPV virus that causes anal warts has been associated with anal cancer and with its preliminary lesion known as anal intraepithelial neoplasia (AIN). This study touches on two important, relevant and costly healthcare issues: finding a better treatment for the most common sexually transmitted disease in our country, and helping to prevent anal cancer, which is often a fatal disease.

Arms: arm 1: Patients who are in the control group received a placebo of saline in the upper extremity at initial visit, 2 months and 6 months after enrollment. arm 2: The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity at initial visit, and again at two months and six months after enrollment.
Interventions: intervention 1: Saline intervention 2: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Intervention descriptions: intervention 1: 0.5 ml intervention 2: 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity initially and again at two months and six months after enrollment.

Protocol documents:
Clinical trial NCT00950664
Conditions: Cervical Dystonia
Keywords: cervical dystonia botulinum toxin
Sponsor: Seoul National University Hospital
Start date: 2009-08-01; Completion date: 2011-07-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
1. to examine the non-inferiority of Dysport in the clinical efficacy and safety in comparison with Botox®, assuming a bioequivalence ratio of 2.5:1 units, in the treatment of Cervical dystonia.
2. double blind, randomised, multi center, crossover study

Detailed description:
1. Prospective, randomized, head-to-head, double-blind, cross-over study.
2. Total patients: A group 51, B group 51
3. Study duration: 16 + 4 + 16 weeks. Eligible patients will be randomised at baseline to receive either Dysport® or Botox® and monitored at weeks 2, 4, 8, 12, 16 weeks. After 4 weeks of wash out period, then the patients get the other treatment (i.e, Patients who have got Dysport will be then administered with Botox)
4. Compare the TSUI change score from baseline to 4 weeks after injection.

Arms: arm 1: Dysport® injection in first intervention period and Botox® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA) arm 2: Botox® injection in first intervention period and Dysport® in second intervention period (after washout period) cross over injection of Dysport® (abobotulinumtoxinA) and Botox® (onabotulinumtoxinA)
Interventions: intervention 1: Dysport® (abobotulinumtoxinA) intervention 2: Botox® (onabotulinumtoxinA)
Intervention descriptions: intervention 1: Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units intervention 2: Cross over injection of Dysport® (\<500IU), Botox® (200IU)assuming a bioequivalence ratio of 2.5:1 units

Protocol documents:
Clinical trial NCT00970606
Conditions: Acute Respiratory Distress Syndrome Influenza H1N1 Influenza
Keywords: ARDS H1N1 Influenza Statin
Sponsor: Gordon Bernard
Start date: 2009-10-01; Completion date: 2011-07-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy and safety of oral rosuvastatin in patients with suspected or confirmed influenza who require intensive care unit (ICU) admission due to respiratory distress.

Detailed description:
Hypothesis: Rosuvastatin therapy will improve mortality and reduce the need for mechanical ventilation in patients experiencing respiratory distress as a complication of influenza.

Arms: arm 1: Placebo arm 2: Experimental arm
Interventions: intervention 1: Rosuvastatin (crestor) intervention 2: Placebo
Intervention descriptions: intervention 1: 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge intervention 2: Placebo tablet identical to active therapy. 1 tablet per day

Protocol documents:
Clinical trial NCT00974246
Conditions: Chronic Obstructive Pulmonary Disease Depression
Keywords: COPD Depression Nursing Home
Sponsor: Valley Medical Research
Start date: 2009-10-01; Completion date: 2011-07-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effect of treatment with Advair Diskus on depression using the Cornell depression scale in COPD patients in the nursing home.

Detailed description:
We are studying 35 residents in the ECF with a diagnosis of COPD. We are evaluating them for depressive symptoms using the Cornell Depression Scale and the MDS 3.0 section D. We are selecting patients who are not currently on treatment with Advair and starting them on Advair Diskus50/250 1 inhalation bid for a period of 16 weeks and reassessing the Cornell Depression SCale and MDS3.0 section D looking for any changes. We are also going to measure FEV1 and FVC using spirometry before treatment and at the end of 16 weeks. This is a pilot study. The numbers are not necessarily adequate to achieve statistical difference-we are looking for trends.

Arms: arm 1: open label treatment with Advair diskus in COPD patients
Interventions: intervention 1: Advair diskus
Intervention descriptions: intervention 1: Advair diskus 50/250 1 inhalation bid for 16 weeks

Protocol documents:
Clinical trial NCT00976599
Conditions: Rheumatoid Arthritis
Sponsor: Pfizer
Start date: 2009-11-01; Completion date: 2011-07-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CP-690,550 + methotrexate intervention 2: Placebo + Methotrexate
Intervention descriptions: intervention 1: CP-690,550 dose is 10 mg twice daily, oral tablets, for 4 weeks Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week intervention 2: Methotrexate dose is ≥ 7.5 mg / week and ≤ 25 mg / week

Protocol documents:
Clinical trial NCT00983814
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder ADHD Adult ADHD Adult Attention Deficit Hyperactivity Disorder
Sponsor: Chelsea Therapeutics
Start date: 2009-10-01; Completion date: 2011-07-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, talking out of turn, difficulty waiting and interrupting others. ADHD is the second most common neuropsychiatric disorder affecting 4.4% of the United States (US) adult population, or between 8-9 million individuals.

Droxidopa (L-dihydroxyphenylserine (L-DOPS)) is a synthetic catecholamine which is converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE centrally in the central nervous system (CNS) and peripherally. Co-treatment with carboxylase inhibitors, such as carbidopa, given with droxidopa, can increase the CNS levels of NE with greater crossing of the blood-brain barrier. Droxidopa has received orphan drug approval by the Food and Drug Administration (FDA) for the treatment of symptomatic neurogenic orthostatic hypotension in individuals with primary autonomic failure. The half-life of droxidopa is approximately 2-3 hours, resulting in administration three times daily.

Detailed description:
This will be a 12-week study of twenty enrolled participants with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) criteria adult ADHD (age 18-55), with a goal of completing twenty participants in the trial. The primary objective of this study is to determine the effect of droxidopa therapy on adult ADHD symptoms over the course of a six-week open-label titration period followed by a two-week double-blind, placebo-controlled period. The primary outcome measure will be changes from baseline in total score on the Adult ADHD Investigator Symptom Rating Scale (AISRS). Secondary measures will be changes in self-reported ADHD symptoms on the Adult ADHD Self-Report Scale (ASRS v1.1) and global impairment on the Clinician Global Impression Scale (CGI).

Arms: arm 1: 3 weeks of open label droxidopa (200, 400, or 600 milligrams \[mg\] three times daily \[TID\]) monotherapy followed by 3 weeks of droxidopa in combination with carbidopa (25 mg or 50 mg TID). arm 2: 2 week double-blind period in which participants either continued to receive droxidopa+carbidopa treatment or placebo
Interventions: intervention 1: Droxidopa+Carbidopa
Intervention descriptions: intervention 1: 3 weeks of open label droxidopa (L-dihydroxyphenylserine (L-DOPS)) (200, 400, or 600mgs TID) monotherapy followed by 3 weeks of droxidopa in combination with carbidopa (25mg or 50mg TID) followed by 2 weeks of double blind continued droxidopa+carbidopa or placebo

Protocol documents: