ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00675025
Conditions: Down Syndrome
Sponsor: Eisai Inc.
Start date: 2008-04-04; Completion date: 2008-12-15
Enrollment: 117 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

Detailed description:
All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.

Arms: arm 1: All participants started with a dose of 2.5 mg/day (2.5 mL/day). Dose escalations occurred in 2.5 mg/day increments every 2 weeks (steady state levels assumed to have been reached) to a maximum dose of 10 mg/day, according to the participant's weight schedule and the Investigator's judgment of safety and tolerability. Re-titration was done to maintain the blinding of the double-blind study (E2020-A001-219). Doses could be decreased due to tolerability and could be increased or decreased to maintain a maximum dose of 0.1 to 0.2 mg/kg/day based on the participant's weight at clinic visits during the study duration.
Interventions: intervention 1: Donepezil hydrochloride (Aricept)
Intervention descriptions: intervention 1: Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.

Protocol documents:
Clinical trial NCT00575159
Conditions: Diabetes Mellitus, Type 1
Keywords: type 1 Diabetes mellitus, pharmacokinetics, pharmacodynamics Adult male and females,
Sponsor: GlaxoSmithKline
Start date: 2008-03-31; Completion date: 2008-12-18
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this research study is to look at concentrations of GSK189075 in blood when single doses of the drug are taken by mouth in combination with basal insulin. The clinical effects of the drug in combination with insulin on the body will also be studied. The results will help determine doses of GSK189075 can be studied in the future in the type I diabetes mellitus population.

Detailed description:

Arms: arm 1: GSK189075 arm 2: Placebo
Interventions: intervention 1: GSK189075 intervention 2: placebo
Intervention descriptions: intervention 1: investigational drug intervention 2: placebo comparator

Protocol documents:
Clinical trial NCT00697515
Conditions: ADHD
Sponsor: Shire
Start date: 2008-07-18; Completion date: 2008-12-20
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult workplace environment (AWE) setting

Detailed description:
This study has both an optimization and double-blind period

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LDX intervention 2: Placebo
Intervention descriptions: intervention 1: oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting intervention 2: Placebo administered once-daily for one week during the adult workplace environment setting

Protocol documents:
Clinical trial NCT01586364
Conditions: Atrophy Vaginal Diseases
Keywords: Menopausal symptoms Vulvar and vaginal atrophy in menopausal women Vaginal atrophy Urogenital atrophy
Sponsor: Shionogi
Start date: 2006-05-08; Completion date: 2008-12-22
Enrollment: 301 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

Detailed description:

Arms: arm 1: Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.
Interventions: intervention 1: Ospemifene 60Mg Oral Tablet
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00676052
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD Multicenter GSK233705B double-blind Chronic Obstructive Pulmonary Disease (COPD) randomized
Sponsor: GlaxoSmithKline
Start date: 2008-05-16; Completion date: 2008-12-22
Enrollment: 576 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of GSK233705B compared with placebo in subjects with COPD.

Detailed description:

Arms: arm 1: GSK233705 12.5mcg arm 2: GSK233705 25mcg arm 3: GSK233705 50mcg arm 4: GSK233705 100mcg arm 5: GSK233705 200mcg arm 6: Placebo
Interventions: intervention 1: GSK233705 12.5mcg intervention 2: GSK233705 25mcg intervention 3: GSK233705 50mcg intervention 4: GSK233705 100mcg intervention 5: GSK233705 200mcg intervention 6: Placebo
Intervention descriptions: intervention 1: Once daily via dry powder inhaler intervention 2: once daily via dry powder inhaler intervention 3: Once daily via dry powder inhaler intervention 4: Once daily via dry powder inhaler intervention 5: Once daily via dry powder inhaler intervention 6: Once daily via dry powder imhaler

Protocol documents:
Clinical trial NCT00749749
Conditions: Pain, Postoperative
Keywords: Abdominal Hysterectomy Postoperative pain
Sponsor: Innocoll
Start date: 2008-09-10; Completion date: 2008-12-22
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the CollaRx Bupivacaine Implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 96 hours after abdominal hysterectomy when compared to the ON-Q PainBuster Post-op Pain Relief System.

Detailed description:
Hysterectomy is the second most common surgery among women in the United States (US). Abdominal hysterectomy surgery may be performed to treat benign tumors, such as fibroids, heavy periods, painful periods and chronic pelvic pain. The most common route for performing hysterectomy is through an incision in the abdominal wall; however, about 20% are performed vaginally.Laparoscopic assisted vaginal hysterectomy is performed when warranted.

Bupivacaine is a local anesthetic (pain medication) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cattle tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

The ON Q system consists of 1 elastometric pump with a fill volume of 270 mL containing 0.25% bupivacaine; 1 soaker catheter measuring 12.5 cm in size; and a fill port, tubing, clamp, filter and flow restrictor. The pump provides positive pressure and is portable. It may be attached to the patient's dressing or placed in a carrying pouch. The catheter is inserted directly into the surgical wound providing a continuous flow of bupivacaine into the wound. A capillary flow restricting orifice located at the end of the tubing controls the flow rate.

This study will compare the total narcotic use in patients with the CollaRx Bupivacaine Implant with the total narcotic use in patients with the ON Q PainBuster Post op Pain Relief System after abdominal hysterectomy.

Arms: arm 1: Three Bupivacaine sponges placed at different levels within the surgical cavity; one deep within the vault, one at the incision line in the peritoneum and one at the dermal incision line. arm 2: Insertion of the ON-Q system catheter into the deep subcutaneous space overlying the fascia.
Interventions: intervention 1: Bupivacaine Collagen Sponge (CollaRx Bupivacaine Implant) intervention 2: ON-Q PainBuster Post-op Pain relief System
Intervention descriptions: intervention 1: The bupivacaine collagen sponge contains 70mg Type I bovine collagen and 50mg bupivacaine hydrochloride intervention 2: 5 mL/hr per catheter of 0.25% bupivacaine (12.5 mg) for 72 hours(total dose 360 mL \[900 mg\])

Protocol documents:
Clinical trial NCT00471237
Conditions: Osteoporosis
Keywords: bone mineral density, Ronacaleret teriparatide alendronate, Post-menopausal women, osteoporosis, SB-751689
Sponsor: GlaxoSmithKline
Start date: 2007-05-14; Completion date: 2008-12-26
Enrollment: 564 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12 month study designed to evaluate the safety and effectiveness of SB-751689 in the treatment of osteoporosis in post-menopausal women, in comparison with 2 active comparators and placebo.

Detailed description:

Arms: arm 1: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 2: All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 3: Open-label arm. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study arm 4: 4 arms, 100mg, 200mg, 300mg, 400mg. All subjects will take calcium (500-660mg elemental daily) and vitamin D (at least 400IU daily) supplements once daily in the evening throughout the study.
Interventions: intervention 1: Ronacaleret intervention 2: Teriparatide intervention 3: Alendronate
Intervention descriptions: intervention 1: 100mg, 200mg, 300mg, 400mg intervention 2: PTH (1-34) intervention 3: Bisphosphonate

Protocol documents:
Clinical trial NCT00577577
Conditions: Myotonic Dystrophy Type 1
Sponsor: Insmed Incorporated
Start date: 2007-12-01; Completion date: 2008-12-29
Enrollment: 69 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the effects of rhIGF-I/rhIGFBP-3 treatment for 24 weeks on endurance, ambulation, cognitive functioning, insulin resistance, lipid levels, muscle function and strength, pain, gastrointestinal functioning, and quality of life endpoints in DM1 patients

Detailed description:
Efficacy Measures:

Endurance, Ambulation, Cognitive function, Insulin resistance, Cholesterol and triglycerides, Muscle function and strength, Pain, Gastrointestinal function, Quality of life

MINIMUM INCLUSION CRITERIA

1. A diagnosis of DM1, confirmed by DM1 genetic mutation
2. Age 21 to 65 years (inclusive)
3. Ability to walk 30 feet - assistance with cane and/or leg bracing permitted
4. Able to self-administer study medication by subcutaneous injection or caregiver is available to administer study medication

Arms: arm 1: None arm 2: None
Interventions: intervention 1: rhIGF-I/rhIGFBP-3 intervention 2: placebo
Intervention descriptions: intervention 1: 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit. intervention 2: 1.0 mg/kg rhIGF-I/rhIGFBP-3 or placebo daily, subcutaneous injections from baseline through the last day of the end of study visit.

Protocol documents:
Clinical trial NCT00697788
Conditions: Burns Sedation
Keywords: pediatric burn sedation
Sponsor: Massachusetts General Hospital
Start date: 2007-07-16; Completion date: 2008-12-30
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

Detailed description:
This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.

Arms: arm 1: Ascending doses of dexmedetomidine (as per protocol)
Interventions: intervention 1: Dexmedetomidine
Intervention descriptions: intervention 1: Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine \[in ug/kg/hr\], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.

Protocol documents:
Clinical trial NCT00381381
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Sponsor: Eisai Korea Inc.
Start date: 2006-05-31; Completion date: 2008-12-31
Enrollment: 199 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Donepezil
Intervention descriptions: intervention 1: 2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.

Protocol documents:
Clinical trial NCT00050011
Conditions: Breast Neoplasms Osteoporosis
Keywords: cancer-treatment related bone loss postmenopausal women breast cancer hormone receptor positive breast cancer adjuvant therapy hormonal therapy bone loss bisphosphonates ZFAST Letrozole Zoledronic Acid US32
Sponsor: Novartis Pharmaceuticals
Start date: 2002-09-01; Completion date: 2009-01-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol is designed to compare the effect on bone of Zoledronic Acid 4 mg every 6 months when given upfront versus delayed start (based on a post-baseline BMD T- Score below -2.0 SD at either the lumbar spine or total hip, or any clinical fracture unrelated to trauma, or an asymptomatic fracture discovered at the month 36 scheduled visit) in stage I-IIIb postmenopausal women with hormone receptor positive breast cancer who will receive Letrozole 2.5 mg daily as an adjuvant therapy.

Detailed description:

Arms: arm 1: Participants in the upfront arm received zoledronate 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily. arm 2: In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronate 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.
Interventions: intervention 1: Zoledronic Acid intervention 2: Letrozole
Intervention descriptions: intervention 1: Participants received Zoledronate 4 mg IV 15-minute infusion every 6 months. intervention 2: Participants received Letrozole 2.5 mg daily.

Protocol documents:
Clinical trial NCT00141453
Conditions: Diabetic Nephropathy Type 2 Diabetes Mellitus Proteinuria
Keywords: angiotensin II type I receptor blockers diabetic nephropathy end-stage renal disease renal failure type 2 diabetes olmesartan medoxomil
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2003-04-01; Completion date: 2009-01-01
Enrollment: 577 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the effectiveness and safety of olmesartan versus placebo on the progression of diabetic renal disease.

Detailed description:

Arms: arm 1: Olmesartan medoxomil tablets 10mg to 40 mg arm 2: Matching placebo tablets
Interventions: intervention 1: olmesartan medoxomil intervention 2: Placebo Tablets
Intervention descriptions: intervention 1: Tablets 10, 20, or 40 mg intervention 2: Matching placebo tablets

Protocol documents:
Clinical trial NCT00266877
Conditions: Carcinoma, Non-Small-Cell Lung Lung Neoplasms
Keywords: Lung Cancer HKI-272 Neratinib Nerlynx
Sponsor: Puma Biotechnology, Inc.
Start date: 2005-12-01; Completion date: 2009-01-01
Enrollment: 172 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.

Detailed description:

Arms: arm 1: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening arm 2: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening arm 3: HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, \< or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)
Interventions: intervention 1: HKI-272
Intervention descriptions: intervention 1: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Protocol documents:
Clinical trial NCT00452530
Conditions: Deep Vein Thrombosis Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery
Sponsor: Bristol-Myers Squibb
Start date: 2007-06-01; Completion date: 2009-01-01
Enrollment: 3221 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.

Detailed description:

Arms: arm 1: Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery. arm 2: Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
Interventions: intervention 1: Enoxaparin intervention 2: Apixaban intervention 3: Enoxaparin-matching placebo intervention 4: Apixaban-matching placebo
Intervention descriptions: intervention 1: 40 mg, administered once daily by subcutaneous injection, for 12 days intervention 2: 2.5 mg, administered twice daily as tablets, for 12 days intervention 3: Administered once daily by subcutaneous injection intervention 4: Oral tablet administered twice daily

Protocol documents:
Clinical trial NCT00454584
Conditions: Psoriasis
Keywords: Psoriasis CNTO 1275 Etanercept Immune diorder Skin disorder
Sponsor: Centocor, Inc.
Start date: 2007-03-01; Completion date: 2009-01-01
Enrollment: 903 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of CNTO 1275 to etanercept in patients with moderate to severe plaque psoriasis.

Detailed description:
This is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. Patients will be randomly (allocation to treatments available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups. The three treatment groups are: Group 1 - CNTO 1275 45 mg dosing at weeks 0 and 4, Group 2 - CNTO 1275 90 mg dosing at weeks 0 and 4, Group 3 - Etanercept 50 mg two times per week through week 12. The total duration for each participant will be up to 64 weeks (approximately 16 months). The active-controlled portion of the study is from Week 0 to Week 12 during which the efficacy and safety of etanercept and 2 dose levels of CNTO 1275 will be evaluated. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. Patients will receive 2 subcutaneous injections of CNTO 1275 (either 45 or 90 mg doses) or twice weekly injections of etanercept during the first twelve weeks of the study. Patients may receive two additional doses of CNTO 1275 (either 45 or 90 mg doses) up to week 44.

Arms: arm 1: Patients will receive CNTO 1275 45 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on Physician's Global Assessment (PGA) response at Week 12 and initial treatment assignment. arm 2: Patients will receive CNTO 1275 90 mg at the Weeks 0 and 4 visits. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment. arm 3: Patients will receive Etanercept 50 mg twice weekly through Week 12. Treatment after Week 12 is dependent on PGA response at Week 12 and initial treatment assignment.
Interventions: intervention 1: CNTO 1275 45 mg intervention 2: CNTO 1275 90 mg intervention 3: Etanercept 50 mg
Intervention descriptions: intervention 1: Type=exact number, number=45, unit=mg, form=injection, route=subcutaneous intervention 2: Type=exact number, number=90, unit=mg, form=injection, route=subcutaneous intervention 3: Type=exact number, number=50, unit=mg, form=injection, route=subcutaneous

Protocol documents:
Clinical trial NCT00638378
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Sponsor: Incyte Corporation
Start date: 2008-02-01; Completion date: 2009-01-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a clinical trial of orally administered Ruxolitinib (INCB018424) in patients whose disease has progressed following 1 prior chemotherapy regimen (not including anti-androgens or ketoconazole) for metastatic, androgen-independent prostate cancer.

Detailed description:

Arms: arm 1: Participants received ruxolitinib 25 mg orally twice daily in 12-hour intervals for 21-day cycles for as long as the study medication was tolerated and provided clinical benefit.
Interventions: intervention 1: Ruxolitinib
Intervention descriptions: intervention 1: Ruxolitinib 25 mg tablets taken with water twice a day.

Protocol documents:
Clinical trial NCT00658788
Conditions: Psoriasis
Sponsor: Galderma R&D
Start date: 2008-03-01; Completion date: 2009-01-01
Enrollment: 305 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Detailed description:
Same as above.

Arms: arm 1: clobetasol propionate spray 0.05%

Other Names:

Clobex® Spray 0.05% clobetasol propionate spray, 0.05%, applied topically twice daily

calcitriol ointment

Other Names:

Calcitriol Ointment calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily
Interventions: intervention 1: clobetasol propionate spray 0.05% intervention 2: calcitriol ointment
Intervention descriptions: intervention 1: clobetasol propionate spray, 0.05%, applied topically twice daily intervention 2: calcitriol ointment, 3 µg/g, applied topically, not to exceed 30 g daily

Protocol documents: