ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00740129
Conditions: Paget's Disease of the Bone
Keywords: Paget's Disease Zoledronic acid Reclast®/Aclasta® Infusion Re-treatment Re-lapse
Sponsor: Novartis Pharmaceuticals
Start date: 2008-10-21; Completion date: 2011-03-14
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to demonstrate that participants with Paget's disease of the bone who had responded to zoledronic acid treatment as participants in the core registration studies CZOL446K2304 and CZOL446K2305 and later experienced a relapse can be successfully treated with a 5 milligram (mg) infusion of zoledronic acid.

Detailed description:
Uncontrolled study

Arms: arm 1: Participants received single re-treatment dose of zoledronic acid 5 mg intravenous (IV) infusion.
Interventions: intervention 1: Zoledronic Acid
Intervention descriptions: intervention 1: Zoledronic acid 5 mg intravenous infusion once

Protocol documents:
Clinical trial NCT00763971
Conditions: ADHD
Sponsor: Shire
Start date: 2008-11-17; Completion date: 2011-03-16
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD.

Detailed description:

Arms: arm 1: Overencapsulated LDX 30, 50, or 70mg arm 2: Overencapsulated Concerta 18, 36, or 54mg arm 3: Overencapsulated Placebo
Interventions: intervention 1: Lisdexamfetamine Dimesylate (LDX) intervention 2: Methylphenidate Hydrochloride intervention 3: Placebo
Intervention descriptions: intervention 1: 30, 50 or 70mg capsule once per day (Overencapsulated) intervention 2: 18, 36, or 54mg tablet one per day (Overencapsulated) intervention 3: Placebo capsule once per day (Overencapsulated)

Protocol documents:
Clinical trial NCT00509262
Conditions: Diabetes Mellitus, Type 2 Renal Insufficiency, Chronic
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-10-09; Completion date: 2011-03-16
Enrollment: 426 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in participants with moderate or severe renal insufficiency.

Detailed description:

Arms: arm 1: Sitagliptin + Placebo for Glipizide arm 2: Glipizide + Placebo for Sitagliptin
Interventions: intervention 1: Sitagliptin intervention 2: Glipizide intervention 3: Placebo for Sitagliptin intervention 4: Placebo for Glipizide
Intervention descriptions: intervention 1: Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily intervention 2: Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily) intervention 3: Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily intervention 4: Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily

Protocol documents:
Clinical trial NCT00570492
Conditions: Rhinitis, Allergic, Perennial
Keywords: allergic rhinitis fluticasone furoate nasal spray growth
Sponsor: GlaxoSmithKline
Start date: 2007-11-26; Completion date: 2011-03-17
Enrollment: 474 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to characterize, as accurately as possible, the estimation of the difference in pre-pubescent growth velocities between subjects treated continuously for one year with FFNS 110mcg QD, the highest dose approved for pediatric use in the US, and placebo nasal spray as determined by stadiometry.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fluticasone furoate nasal spray intervention 2: Placebo nasal spray
Intervention descriptions: intervention 1: Fluticasone furoate nasal spray 110mg QD intervention 2: Placebo nasal spray

Protocol documents:
Clinical trial NCT00729183
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-02; Completion date: 2011-03-21
Enrollment: 214 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and treatment effect of 50 mg odanacatib (MK-0822) with Vitamin D versus placebo with Vitamin D in postmenopausal women with low bone density. The primary efficacy hypothesis is that odanacatib will increase aBMD at the lumbar spine compared to placebo at 12 months.

Detailed description:

Arms: arm 1: Participants receive 50 mg odanacatib and open-label 5600 IU vitamin D3 tablets once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg. arm 2: Participants receive matching placebo to odanacatib and open-label 5600 IU vitamin D3 once weekly for 24 months. Participants also receive 500 mg of open-label daily calcium supplement as needed to ensure a total daily calcium intake of 1200 mg.
Interventions: intervention 1: Odanacatib intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium supplement
Intervention descriptions: intervention 1: Odanacatib 50 mg tablets, taken orally once weekly for 24 months. intervention 2: Matching placebo tablets to odanacatib taken orally once weekly for 24 months. intervention 3: Vitamin D3 tablets (5600 IU) taken orally once weekly for 24 months. intervention 4: Calcium supplement 500 mg tablet taken orally once daily (up to \~1200 mg total) for 24 months.

Protocol documents:
Clinical trial NCT01122030
Conditions: Opioid Induced Bowel Dysfunction
Keywords: Chronic pain Opioid physical dependence
Sponsor: Shionogi
Start date: 2010-05-19; Completion date: 2011-03-22
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to evaluate the safety of single doses of oral naldemedine in adults physically dependent on opioids.

Detailed description:
A single dose of naldemedine or matching placebo will be administered orally to each cohort of 12 participants (9 treatments, 3 placebos) in the morning of Day 15 under fasted conditions. The first cohort will receive a 0.1 mg dose. Cohorts will continue to be enrolled at the next higher dose level until the highest dose level (3 mg) has been achieved or until the study is discontinued due to adverse events or Clinical Opioid Withdrawal Score of \>8. A 0.03 mg dose will also be tested. A 0.01 mg dose will be tested if 4 or more subjects experience 1 or more bowel movements within the 24 hour period post dose in the 0.03 mg dosing cohort.

Arms: arm 1: In this cohort 9 participants received one 0.1 mg naldemedine tablet and 3 participants received matching placebo administered on Day 15 under fasted conditions. arm 2: In this cohort 9 participants received a single dose of 0.3 mg naldemedine tablets and 3 participants received matching placebo tablets administered on Day 15 under fasted conditions. arm 3: In this cohort 9 participants received a single dose of 1 mg naldemedine tablets and 3 participants received matching placebo tablets administered on Day 15 under fasted conditions. arm 4: In this cohort 9 participants received a single dose of 3 mg naldemedine tablets and 3 participants received matching placebo tablets administered on Day 15 under fasted conditions. arm 5: In this cohort 9 participants received a single dose of 0.03 mg naldemedine oral solution and 3 participants received matching placebo oral solution administered on Day 15 under fasted conditions. arm 6: In this cohort 9 participants received a single dose of 0.01 mg naldemedine oral solution and 3 participants received matching placebo oral solution administered on Day 15 under fasted conditions.
Interventions: intervention 1: Naldemedine intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets or solution for oral administration intervention 2: Tablets or solution for oral administration

Protocol documents:
Clinical trial NCT00722371
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-05; Completion date: 2011-03-25
Enrollment: 1615 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
Interventions: intervention 1: Sitagliptin phosphate intervention 2: Pioglitazone hydrochloride intervention 3: Matching placebo to sitagliptin intervention 4: Matching placebo to pioglitazone intervention 5: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet (blinded) orally once daily for 54 weeks. intervention 2: Pioglitazone 15 mg, 30 mg, or 45 mg tablets or capsules (blinded) orally once daily for 54 weeks. Participants randomized to receive pioglitazone 45 mg as monotherapy or in combination with sitagliptin were to start on pioglitazone 30 mg at Week 1 and undergo uptitration to pioglitazone 45 mg at Week 4. intervention 3: Matching placebo to sitagliptin orally once daily for 54 weeks. intervention 4: Matching placebo to pioglitazone tablets or capsules orally once daily for 54 weeks. intervention 5: Metformin 500 mg (open-label) was to be initiated as rescue therapy to participants not meeting specific glycemic goals. The dose of metformin may have been uptitrated and adjusted, at the discretion of the investigator, up to the maximum approved dose in the country of origin.

Protocol documents:
Clinical trial NCT01147640
Conditions: Complicated Intra-abdominal Infection
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2010-06-25; Completion date: 2011-03-25
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2, multicenter, prospective, randomized, double-blind study of CXA-101/ tazobactam (1000/500 mg q8h) and metronidazole (500 mg q8h) IV infusion vs. meropenem IV infusion (1000 mg q8h) and a matching saline placebo (q8h) in the treatment of cIAI in adult subjects. Dose adjustments for subjects with mild renal impairment are not necessary and subjects with more severe degrees of renal failure are excluded.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CXA-101/ tazobactam and metronidazole intervention 2: meropenem plus saline placebo
Intervention descriptions: intervention 1: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion intervention 2: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion

Protocol documents:
Clinical trial NCT01092143
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2010-03-18; Completion date: 2011-03-26
Enrollment: 389 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6 week study to investigate the effectiveness and safety of BI 671800 ED in patients with asthma who do not take inhaled corticosteroids.

Detailed description:

Arms: arm 1: Patients receive BI 671800 (low dose) capsules twice daily arm 2: Patients inhale from Fluticasone propionate metered dose inhaler (MDI) twice daily arm 3: Patients receive placebo capsules twice daily arm 4: Patients receive BI 671800 (medium dose) capsules twice daily arm 5: Patients receive BI 671800 (high dose) capsules twice daily
Interventions: intervention 1: BI 671800 intervention 2: Fluticasone propionate placebo intervention 3: Fluticasone propionate intervention 4: BI 671800 Placebo
Intervention descriptions: intervention 1: BI 671800 intervention 2: Placebo matching Fluticasone propionate intervention 3: Fluticasone propionate intervention 4: Placebo matching BI 671800

Protocol documents:
Clinical trial NCT01323673
Conditions: Dermatitis, Chronic
Sponsor: Stiefel, a GSK Company
Start date: 2010-11-15; Completion date: 2011-03-29
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine how clobetasol proprionate foam works against a placebo foam in the treatment of hand dermatitis.

Detailed description:
Topical corticosteroids have anti-inflammatory, immunosuppressive and antiproliferative properties. Clobetasol propionate foam 0.05% (Olux-E), a Class 1 corticosteroid, is formulated in an ethanol free petrolatum base that provides the benefits of a super-potent corticosteroid combined with moisturizing ingredients in the treatment of corticosteroid responsive dermatoses. The current study is designed to show efficacy and safety in the treatment of moderate to severe chronic hand dermatitis.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: clobetasol propionate 0.05% intervention 2: Vehicle / Placebo
Intervention descriptions: intervention 1: 2 times a day, 14 total days study treatment intervention 2: 2 times a day, 14 total days of study treatment

Protocol documents:
Clinical trial NCT01140867
Conditions: Epilepsy
Sponsor: Eisai Korea Inc.
Start date: 2008-02-29; Completion date: 2011-03-31
Enrollment: 121 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

Detailed description:
The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 \~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures \[SPS\], complex partial seizures \[CPS\], simple partial seizures evolving into generalized tonic-clonic convulsions \[SGTC\] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.

Arms: arm 1: None
Interventions: intervention 1: zonisamide
Intervention descriptions: intervention 1: zonisamide 100 mg tablet

Protocol documents:
Clinical trial NCT01266161
Conditions: Pain
Keywords: dental pain multiple dose ibuprofen third molar extraction
Sponsor: Pfizer
Start date: 2010-11-22; Completion date: 2011-03-31
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide analgesic efficacy superior to placebo over 12-hour dosing intervals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ibuprofen 600 mg ER intervention 2: Placebo
Intervention descriptions: intervention 1: One 600 mg caplet dosed at 0, 12, 24 and 36 hours intervention 2: One placebo caplet dosed at times 0, 12, 24 and 36 hours

Protocol documents:
Clinical trial NCT00298363
Conditions: Chronic Hepatitis B
Keywords: Hepatitis; Hepatitis B virus; Tenofovir
Sponsor: Gilead Sciences
Start date: 2006-04-01; Completion date: 2011-04-01
Enrollment: 112 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to evaluate and compare the safety and tolerability of tenofovir disoproxil fumarate (TDF), emtricitabine (FTC)/TDF, and entecavir (ETV) in the treatment of hepatitis B patients with decompensated liver disease. Safety was assessed by evaluating adverse events (AEs) and laboratory abnormalities. Efficacy was assessed by evaluating reductions in Child-Pugh-Turcotte (CPT) and Model for End Stage Liver Disease (MELD) scores, reductions in hepatitis B virus (HBV) deoxyribonucleic acid (DNA), changes in liver enzymes, development of drug-resistant mutations, and generation of antibody to virus.

A maximum randomized treatment duration of 168 weeks was planned. Since subjects with decompensated liver disease were enrolled into this study, it was necessary to provide early intervention strategies if profound viral suppression was not expeditiously achieved. For this reason, subjects with a decrease in plasma HBV DNA from baseline of \< 2 log\_10 copies/mL and plasma HBV DNA \> 10,000 copies/mL (or plasma HBV DNA \> 1,000 copies/mL for subjects who entered the study with HBV DNA \< 10,000 copies/mL) at Week 8 had the option to start open-label FTC/TDF and continue in the study. Subjects with a virologic breakthrough or who had plasma HBV DNA levels remaining \> 400 copies/mL (confirmed) at or after 24 weeks of treatment could have been unblinded at the investigator's discretion for selection of alternative anti-HBV therapy that may have included open-label FTC/TDF. If study drug was permanently discontinued, immediate initiation of another anti-HBV regimen was strongly recommended.

Detailed description:

Arms: arm 1: TDF 300 mg + FTC/TDF placebo + ETV placebo once daily (QD) arm 2: FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo QD arm 3: ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo QD
Interventions: intervention 1: Tenofovir disoproxil fumarate (tenofovir DF; TDF) intervention 2: Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) intervention 3: Entecavir (ETV) intervention 4: TDF placebo intervention 5: FTC/TDF placebo intervention 6: ETV placebo
Intervention descriptions: intervention 1: 300-mg tablet QD intervention 2: FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet QD intervention 3: 0.5-mg or 1-mg tablet QD intervention 4: Placebo to match TDF QD intervention 5: Placebo to match FTC/TDF QD intervention 6: Placebo to match ETV QD

Protocol documents:
Clinical trial NCT00422903
Conditions: Neoplasms, Breast
Keywords: neo-adjuvant letrozole lapatinib primary breast cancer
Sponsor: GlaxoSmithKline
Start date: 2007-04-01; Completion date: 2011-04-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole

Detailed description:

Arms: arm 1: Letrozole 2.5 mg administered orally fro 6 mos. plus placebo 1500 mg administered orally throughout the study until definitive surgery arm 2: Letrozole 2.5 mg administered orally fro 6 mos. plus lapatinib 1500 mg administered orally throughout the study until definitive surgery
Interventions: intervention 1: lapatinib intervention 2: letrozole intervention 3: placebo
Intervention descriptions: intervention 1: 1500 mg administered orally daily intervention 2: 2.5 mg administered orally daily intervention 3: 1500 mg administered orally daily

Protocol documents:
Clinical trial NCT00649792
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis MS walking leg strength demyelination
Sponsor: Acorda Therapeutics
Start date: 2007-08-01; Completion date: 2011-04-01
Enrollment: 214 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate the safety, tolerability and activity of Fampridine-SR when administered for up to 36 additional months in patients who previously participated in the MS-F204 study or until it becomes commercially available, whichever comes first.

Detailed description:
Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. These periods of illness may come (exacerbations) and go (remissions). Fampridine-SR is an experimental drug that has been reported to possibly improve muscle strength and walking ability for some people with MS. This study will evaluate the effects and possible risks of taking Fampridine-SR in MS patients over a long period of time.

Interventions: intervention 1: Fampridine-SR
Intervention descriptions: intervention 1: Tablets, 10 mg, BID (twice daily)

Protocol documents:
Clinical trial NCT00724711
Conditions: HIV Infection
Keywords: HIV HIV 1
Sponsor: Gilead Sciences
Start date: 2008-07-01; Completion date: 2011-04-01
Enrollment: 312 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose abacavir (ABC)/lamivudine (3TC) to fixed dose emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) in virologically suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects maintained on a ritonavir-boosted protease inhibitor (PI/r)-containing antiretroviral (ARV) regimen. Duration of treatment is 48 weeks.

Detailed description:
This protocol describes a prospective, randomized, open-label, multicenter study to evaluate the safety and efficacy of switching from fixed dose ABC/3TC to fixed dose FTC/TDF in virologically suppressed, HIV-1 infected subjects maintained on a PI/r-containing ARV regimen.

Subjects were stratified based on the PI/r (ie, lopinavir/ritonavir \[LPV/r\] versus other boosted PIs) in their regimen, and the presence versus absence of comorbidities at screening (diabetes mellitus or cardiovascular disease such as hypertension, coronary artery disease, hyperlipidemia, history of myocardial infarction, cardiomyopathy, valvular heart disease, congenital heart disease, stroke, peripheral vascular disease, or arrhythmias). Subjects were randomized 1:1 to switch to FTC/TDF+PI/r or to continue on their existing regimen.

Subjects received study treatment for 48 weeks.

Arms: arm 1: Participants in this group received fixed-dose combination FTC 200 mg/TDF 300 mg (Truvada \[TVD\]) for 48 weeks. The prestudy ritonavir-boosted PI was continued unmodified through the 48 weeks of the study. arm 2: Participants in this group continued their prestudy therapy - ABC 600 mg/3TC 300 mg administered as one tablet orally once daily (Epzicom) plus ritonavir-boosted PI regimen, given orally for 48 weeks.
Interventions: intervention 1: emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) intervention 2: abacavir (ABC)/lamivudine (3TC)
Intervention descriptions: intervention 1: FTC 200 mg/TDF 300 mg tablet, once a day intervention 2: ABC 600 mg/3TC 300 mg tablet, once a day

Protocol documents: