ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01068626
Conditions: Abdominal Obesity
Sponsor: Göteborg University
Start date: 2006-05-01; Completion date: 2008-12-01
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.

Detailed description:
The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce coronary artery disease (CAD) events. Although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. The results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. In the present study, we will investigate whether statins can decrease visceral obesity in humans.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rosuvastatin intervention 2: Placebo for rosuvastatin
Intervention descriptions: intervention 1: 10 mg once daily intervention 2: once daily

Protocol documents:
Clinical trial NCT01206608
Conditions: Postoperative Pain
Keywords: Breast augmentation Pain Analgesia
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2008-03-01; Completion date: 2008-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study was to demonstrate the superiority of SKY0402 over conventional, commercially-available bupivacaine HCl with respect to the duration of the analgesic effect achieved by a single local administration of the study drug.

Detailed description:
This was a Phase 2, parallel-group, active-control, randomized, double-blind study conducted to evaluate a single local administration of low dose or high dose of SKY0402 compared with 75 mg of bupivacaine HCl (i.e., Marcaine® 0.5%) in women undergoing bilateral, cosmetic, sub-muscular, augmentation mammoplasty under general anesthesia. Each subject was to serve as her own control.

A total of 40 subjects were randomized in a 1:1 ratio to receive one of the following regimens:

* Low-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.
* Mid-dose SKY0402 in one side and Marcaine 75 mg in the contralateral side.

Study drug was administered locally into the breast implant pocket at the end of surgery. After surgery, subjects were to receive standard treatment with acetaminophen 1000 mg three times daily and rescue analgesia with immediate-release oxycodone, as needed, for breakthrough pain.

Assessments of postoperative pain were conducted through 96 hours. Safety assessments were conducted including monitoring of local and systemic adverse events (AEs).

Arms: arm 1: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402 arm 2: Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
Interventions: intervention 1: SKY0402 + bupivacaine HCl intervention 2: Mid-dose SKY0402 + bupivacaine HCl
Intervention descriptions: intervention 1: Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket intervention 2: Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket

Protocol documents:
Clinical trial NCT01494753
Conditions: Primary Open Angle Glaucoma
Sponsor: Laboratoires Thea
Start date: 2008-06-01; Completion date: 2008-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.

Detailed description:

Arms: arm 1: One drop. arm 2: One drop
Interventions: intervention 1: T2345 intervention 2: Prostaglandin
Intervention descriptions: intervention 1: One drop at 8.00pm. intervention 2: One drop at 8.00pm.

Protocol documents:
Clinical trial NCT01606228
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone ER Treatment naive patients Newly diagnosed patients
Sponsor: Janssen Pharmaceutica
Start date: 2007-12-01; Completion date: 2008-12-01
Enrollment: 188 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.

Detailed description:
This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.

Protocol documents:
Clinical trial NCT01852669
Conditions: Kidney Stone
Sponsor: Monash University
Start date: 2002-01-01; Completion date: 2008-12-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized controlled trial comparing extracorporeal shockwave lithotripsy (ESWL) with and without simultaneous adjunct controlled inversion therapy in the treatment of lower pole caliceal stone.

Detailed description:

Arms: arm 1: ESWL with hydration and inversion arm 2: ESWL with hydration
Interventions: intervention 1: Inversion intervention 2: Shock Wave Lithotripsy intervention 3: Hydration
Intervention descriptions: intervention 1: Patients inverted 30 degree head down in Trendelenburg position intervention 2: Shock wave lithotripsy intervention 3: Hydration of patient with 0.5L NaCl and 20mg frusemide IV

Protocol documents:
Clinical trial NCT02033317
Conditions: Hyperkalemia
Sponsor: Relypsa, Inc.
Start date: 2008-08-01; Completion date: 2008-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the pharmacodynamic effects of patiromer on serum potassium in participants on hemodialysis.

Detailed description:
The initial intent was to enroll 12-24 adult male and female participants on hemodialysis into the study. Due to significant recruitment challenges, the study was discontinued after six participants were enrolled in the study.

This was an open-label, multiple-dose, adaptive-design study in participants on hemodialysis. Eligible participants on hemodialysis were to remain in the Clinical Research Unit for 2 weeks (Day -7 to Day 8) and were required to consume a potassium, magnesium, calcium and sodium-controlled diet.

Arms: arm 1: None
Interventions: intervention 1: patiromer
Intervention descriptions: intervention 1: 15 grams/day (5 grams 3 times daily) administered orally

Protocol documents:
Clinical trial NCT02081183
Conditions: Lupus Nephritis
Sponsor: Hoffmann-La Roche
Start date: 2006-03-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy of CellCept \[0.5-2 grams per day (g/day) orally (p.o.)\] and cyclophosphamide \[0.5-1 grams per square meter (g/m2) quarterly\] as maintenance treatment for patients with lupus nephritis. All patients will receive induction treatment with cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free follow-up. The anticipated time on study treatment is 12 months.

Detailed description:

Arms: arm 1: Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m\^2), intravenously (IV) pulse once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), orally (PO); the dose was reduced by 5 mg/day to a final dose of 10 mg/day.

Maintenance Phase (Months 7 through 12): Participants received mycophenolate mofetil (MMF), 1 g/day, PO, twice daily (BID) for 2 weeks; 1.5 g/day, PO, three times daily (TID) for the next 2 weeks; 2 g/day, PO, BID for the remainder of the Maintenance Phase. Participants also received prednisone, as in the Induction Phase. arm 2: Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 - 1 g/m\^2, IV, pulse once per month. Participants also received prednisone, 1 mg/kg/day), PO; the dose was reduced by 5 mg/day to a final dose of 10 mg/day.

Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m\^2, IV, pulse once every 3 months. Participants also received prednisone, as in the Induction Phase.
Interventions: intervention 1: Mycophenolate mofetil (MMF) intervention 2: Cyclophosphamide, Maintenance Phase intervention 3: Cyclophosphamide, Induction Phase intervention 4: Prednisone
Intervention descriptions: intervention 1: 1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase. intervention 2: 0.5-1 g/m\^2 IV pulse once every 3 months intervention 3: 0.5 - 1 g/m\^2 IV pulse once per month intervention 4: 1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.

Protocol documents:
Clinical trial NCT02169479
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) Opicapone BIA 9-1067
Sponsor: Bial - Portela C S.A.
Start date: 2008-09-01; Completion date: 2008-12-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/carbidopa 100/25 mg (Sinemet® 100/25)

Detailed description:
Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least 14 days. On each treatment period, after completion of pre-dose assessments, BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® 100/25; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose. Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.

Arms: arm 1: Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25 arm 2: Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25 arm 3: Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25 arm 4: Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg

BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Sinemet® 100/25
Intervention descriptions: intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: Immediate-release levodopa/carbidopa 100/25 mg

Protocol documents:
Clinical trial NCT02507375
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Squamous
Sponsor: Hoffmann-La Roche
Start date: 2006-09-01; Completion date: 2008-12-01
Enrollment: 17 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and tolerability, and make a preliminary assessment of activity, of a combination of pertuzumab and erlotinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed on at least one prior chemotherapy regimen. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is less than 100 individuals.

Detailed description:

Arms: arm 1: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 100 mg orally (PO). arm 2: Participants will receive IV infusion of pertuzumab at a loading dose of 840 mg on Day 1, followed by a dose of 420 mg every 3 weeks. Erlotinib will be administered daily, at a dose level of 150 mg orally (PO).
Interventions: intervention 1: Erlotinib intervention 2: Pertuzumab
Intervention descriptions: intervention 1: Erlotinib will be administered as oral tablets. intervention 2: Pertuzumab will be administered as intravenous (IV) infusion.

Protocol documents:
Clinical trial NCT02732639
Conditions: Hepatitis D, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2005-10-01; Completion date: 2008-12-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the efficacy and safety of 48-week treatment with pegylated interferon (PEG-IFN) alfa-2a (Pegasys) monotherapy in participants with chronic hepatitis D (CHD). Treatment was followed by 24 weeks of treatment-free follow-up.

Detailed description:

Arms: arm 1: Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.
Interventions: intervention 1: Pegylated Interferon (PEG-IFN) alfa-2a
Intervention descriptions: intervention 1: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.

Protocol documents:
Clinical trial NCT01825785
Conditions: Postmenopausal Osteopenia
Sponsor: Amgen
Start date: 2007-11-14; Completion date: 2008-12-02
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The primary objective of this study was to assess the safety, tolerability, and immunogenicity potential of romosozumab following multiple subcutaneous (SC) administrations in healthy men and postmenopausal women with low bone mass.

Detailed description:

Arms: arm 1: Participants were randomized to receive matching placebo administered by subcutaneous injection once every 2 weeks (Q2W) or once every 4 weeks (Q4W) for 3 months. arm 2: Participants were randomized to receive romosozumab administered by subcutaneous injection at doses of 1 mg/kg Q2W, 2 mg/kg Q4W, 2 mg/kg Q2W, or 3 mg/kg Q4W for 3 months.
Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT00610649
Conditions: Depression
Keywords: randomized placebo controlled maximum tolerated dose
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-09-20; Completion date: 2008-12-10
Enrollment: 54 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Trial to determine the maximum tolerated dose (MTD) based on safety and tolerability of MK-8777 (Org 26576, SCH 900777) in participants with major depressive disorder.

Detailed description:
This is a randomized, placebo-controlled, safety and tolerability study examining MK-8777 in participants with major depressive disorder. In Part I of the trial, four different cohorts of six participants each will receive multiple rising doses of MK-8777 (ranging from 100 mg twice a day \[BID\] to 300 mg BID) or placebo for up to 16 days. In Part 2, a new cohort of participants will be randomly assigned to receive 100 mg BID of MK-8777, 400 mg BID of MK-8777, or placebo. Following titration (3 days per step), participants will be maintained on the assigned BID dose until Day 27, followed by one day of once a day (QD) dosing, for a total of 28 days. There were 11 treatment arms in total for Part 1 and Part 2 (see Interventions).

Arms: arm 1: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days. arm 2: Participants receive placebo BID for a total of 16 days. arm 3: Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days. arm 4: Participants receive placebo BID for a total of 13 days. arm 5: Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days. arm 6: Participants receive placebo BID for a total of 10 days. arm 7: Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days. arm 8: Participants receive placebo BID for a total of 13 days. arm 9: Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days. arm 10: Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days. arm 11: Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
Interventions: intervention 1: MK-8777 intervention 2: Placebo
Intervention descriptions: intervention 1: Orally administered capsules containing either 50 mg or 100 mg MK-8777. intervention 2: Orally administered matching placebo capsules.

Protocol documents:
Clinical trial NCT00557622
Conditions: Post-Traumatic Stress Disorder Stress Disorders, Post-Traumatic
Keywords: PTSD (Posttraumatic Stress Disorder) CAPS fMRI Paroxetine
Sponsor: GlaxoSmithKline
Start date: 2008-01-25; Completion date: 2008-12-11
Enrollment: 5 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-blind, placebo-controlled, parallel group study to evaluate the efficacy of BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) as assessed by the change from baseline in CAPS-SX total score. Also the effect of paroxetine on regional cerebral blood flow (rCBF) induced by subthreshold emotional arousing (or symptom stimulating) tasks will be determined using functional magnetic resonance imaging (fMRI) for exploratory assessment of the correlation between the change in rCBF and the efficacy.

The sample size is 30 subjects. The study period consists of 4 weeks of run-in phase, 12 weeks of treatment phase, 0-3 weeks of taper phase and follow-up examination at 2 weeks after the last dose, for a total of 18-21 weeks.

Subjects will visit the clinic at the start of run-in phase, Week -2, the start of treatment phase, Weeks 2, 4, 6, 8 and 12 of treatment, and follow-up examination.

Detailed description:

Arms: arm 1: Drug 2 (20 mg/day or placebo) will be administered once daily after supper for the first two weeks after the run-in phase. If the investigator/subinvestigator judges that a sufficient response is achieved, Drug 2 will be continued for the remaining period. If a sufficient response is not achieved with Drug 2 but treatment is well tolerated, the dose will be titrated to one step higher level until a sufficient response is achieved \[i.e., Drug 3 (30 mg/day or placebo) → Drug 4 (40 mg/day or placebo) → Drug 5 (50 m/day or placebo)\] at intervals of at least two weeks by once daily administration after supper. Once a sufficient response is achieved, that dose will be continued. arm 2: placebo
Interventions: intervention 1: paroxetine intervention 2: placebo
Intervention descriptions: intervention 1: BRL29060A (paroxetine hydrochloride hydrate, hereafter paroxetine) administered orally over the dose range of 20 mg to 50 mg once daily after supper for 12 weeks in Japanese patients with posttraumatic stress disorder (PTSD) intervention 2: placebo

Protocol documents:
Clinical trial NCT00673465
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-04-17; Completion date: 2008-12-11
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the effect of SCH 497079 on metabolic parameters and to determine the influence of race/ethnic origin on therapeutic response.

Detailed description:
This study includes two parts, each part includes three consecutive 28-day treatment periods. Part 1 (to be conducted in the United States): each participant will receive the following treatments for 28 days in each of three treatment periods in an order determined by a random code: SCH 497079, or matching placebo, or metformin.

Part 2 (to be conducted in India): this part of the study will be conducted after completion of Part 1 and an analysis indicates a clinically significant decrease in blood glucose in participants with type 2 diabetes mellitus (T2DM) compared to placebo. The same procedures conducted in Part 1 will be conducted in Part 2.

Arms: arm 1: Participants received SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks followed by metformin daily for 4 weeks. arm 2: Participants received placebo daily for 4 weeks followed by metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks. arm 3: Participants received metformin daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by placebo daily for 4 weeks. arm 4: Participants received SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks followed by placebo daily for 4 weeks. arm 5: Participants received placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks followed by metformin daily for 4 weeks. arm 6: Participants received metformin daily for 4 weeks followed by placebo daily for 4 weeks followed by SCH 497079 daily for 4 weeks.
Interventions: intervention 1: SCH 497079 intervention 2: Placebo intervention 3: Metformin
Intervention descriptions: intervention 1: SCH 497079 100 mg capsule, administered orally, once daily for 4 weeks intervention 2: Placebo capsules matching SCH 497079, administered orally, once daily for 4 weeks intervention 3: Metformin extended release 750 mg, 2 tablets administered orally, once daily for 4 weeks (1500 mg total daily dose)

Protocol documents: