ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00832377
Conditions: Glaucoma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-24; Completion date: 2010-03-26
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug administration

Detailed description:

Arms: arm 1: Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Interventions: intervention 1: timolol/dorzolamide combination
Intervention descriptions: intervention 1: Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks

Protocol documents:
Clinical trial NCT00414765
Conditions: Metastatic Renal Cell Carcinoma Metastatic Melanoma
Keywords: Metastatic Renal Cell Carcinoma Metastatic Melanoma Aldesleukin IL-2
Sponsor: Novartis Pharmaceuticals
Start date: 2008-09-03; Completion date: 2010-03-28
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.

Detailed description:

Arms: arm 1: All participants were treated with aldesleukin 600,000 international units per kilogram \[IU/kg\] (0.037 milligram (mg)/kg) administered as a 15-minute intravenous (IV) infusion every 8 hours for a maximum of 14 doses for the first cycle (5-day cycle). Following 9 days of rest from therapy, the cycle was repeated for up to 14 doses (i.e., a total of up to 28 doses), if tolerated.
Interventions: intervention 1: Aldesleukin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01010750
Conditions: Attention-Deficit Hyperactivity Disorder
Keywords: ADHD
Sponsor: Shire
Start date: 2010-01-05; Completion date: 2010-03-28
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.

Detailed description:

Arms: arm 1: Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo arm 2: Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo arm 3: Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo
Interventions: intervention 1: Lisdexamfetamine Dimesylate (LDX) intervention 2: Immediate Release Mixed Amphetamine Salts (MAS-IR) intervention 3: LDX Placebo + MAS-IR Placebo
Intervention descriptions: intervention 1: Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo intervention 2: Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo intervention 3: Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo

Protocol documents:
Clinical trial NCT00284856
Conditions: Asthma
Sponsor: Organon and Co
Start date: 2006-05-01; Completion date: 2010-04-01
Enrollment: 1640 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.

Detailed description:

Arms: arm 1: Arm 1: Montelukast arm 2: Arm 2: Fluticasone arm 3: Arm 3: Placebo
Interventions: intervention 1: montelukast sodium intervention 2: Comparator: Placebo intervention 3: Comparator: fluticasone intervention 4: Comparator: Placebo
Intervention descriptions: intervention 1: montelukast 10 mg tablet once daily, 6 month treatment period intervention 2: fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period intervention 3: fluticasone propionate 250 mcg twice daily, 6 month treatment period intervention 4: montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Protocol documents:
Clinical trial NCT00423449
Conditions: Non-Small Cell Lung Cancer
Keywords: Advanced Stage IIIB/IV Non-Small Cell Lung Cancer
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-03-01; Completion date: 2010-04-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical trial to determine the safety and tolerability of MK0683 in combination with gemcitabine and cisplatin and/or carboplatin.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: vorinostat intervention 2: Gemcitabine intervention 3: Platinum-based agent
Intervention descriptions: intervention 1: Dose escalation study: vorinostat 300-500 mg capsules once daily for 7-14 days in continuous cycles of 21 days intervention 2: Dose escalation study: Gemcitabine 1000-1250 mg/m2 will be given for 2 days in each 21 day cycle intervention 3: Cisplatin IV 75 mg/m2 will be given for 1 day in each 21 day cycle or carboplatin dosed according to renal function.

Protocol documents:
Clinical trial NCT00440193
Conditions: Venous Thrombosis
Sponsor: Bayer
Start date: 2007-03-01; Completion date: 2010-04-01
Enrollment: 3449 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT).

Detailed description:
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation. Participants who were transferring from study 11702 DVT (NCT00440193) to the extension study 11899 (NCT00439725) did not enter the observational period.

Arms: arm 1: Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily arm 2: Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Enoxaparin followed by VKA
Intervention descriptions: intervention 1: During the first 3 weeks patients will receive 15 mg rivaroxaban twice-daily. Thereafter, patients will receive rivaroxaban 20 mg once-daily. Rivaroxaban will be administered orally and should be taken with food. intervention 2: Enoxaparin 1.0 mg/kg twice daily with a minimal duration of 5 days. This 5 days treatment could include the period up to 36 h before randomization if enoxaparin twice-daily was used. VKA should be started as soon as possible but not later than 48 hours after randomization.

Protocol documents:
Clinical trial NCT00483756
Conditions: Kidney Transplantation
Keywords: Immunosuppression JAK3 inhibitor kidney transplantation.
Sponsor: Pfizer
Start date: 2007-08-01; Completion date: 2010-04-01
Enrollment: 338 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In this research study, a JAK3 inhibitor or cyclosporine will be given to new kidney transplant patients for 12 months. Patients will be assigned to one of three treatment groups after receiving a kidney transplant. Two of the treatment groups will receive 2 different dosing regimens of the JAK3 inhibitor that will be taken by mouth. The third treatment group will be a standard-of-care control arm. Patients will continue to take the assigned study medication for 12 months as well as other standard transplant medications such as prednisone.

Detailed description:

Arms: arm 1: Treatment Arm 1 will also receive standard of care medications arm 2: Treatment Arm 2 will also receive standard of care medications arm 3: Treatment Arm 3 will also receive standard of care medications
Interventions: intervention 1: Cyclosporine intervention 2: CP-690,550 intervention 3: CP-690,550
Intervention descriptions: intervention 1: Standard of care intervention 2: CP-690,550 15 mg BID for Months 1-6, then 10 mg BID for Months 7-12 intervention 3: CP-690,550 15 mg BID for Months 1-3, then 10 mg BID for Months 4-12

Protocol documents:
Clinical trial NCT00503113
Conditions: Post-Menopausal Osteoporosis
Sponsor: Hoffmann-La Roche
Start date: 2007-07-01; Completion date: 2010-04-01
Enrollment: 801 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 3 arm study will evaluate renal safety after administration of an intravenous (iv) injection or infusion of Bonviva, compared to oral alendronate, in patients with postmenopausal osteoporosis, at increased risk of renal disease. Patients will be randomized to receive Bonviva 3mg intravenous (iv) by a) injection or b) infusion once every 3 months, or alendronate 70mg per oral (po) weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: ibandronate [Bonviva/Boniva] intervention 2: ibandronate [Bonviva/Boniva] intervention 3: Alendronate
Intervention descriptions: intervention 1: 3mg intravenous (iv) injection every 3 months intervention 2: 3mg intravenous (iv) infusion every 3 months intervention 3: 70mg per oral (po) weekly

Protocol documents:
Clinical trial NCT00518713
Conditions: Epilepsy Epilepsy, Generalized Seizures
Keywords: Epilepsy Lennox-Gastaut Syndrome Drop seizures Clobazam
Sponsor: Lundbeck LLC
Start date: 2007-08-01; Completion date: 2010-04-01
Enrollment: 238 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in patients 2 to 60 years of age with Lennox-Gastaut Syndrome (LGS). Patients will be enrolled at approximately 65 sites in the U.S. and ex-US for up to 23 weeks. Patients will be randomly assigned to either a low, medium or high dose, or placebo. The study will include a baseline period, a titration period and a maintenance period. After the maintenance period, patients will either continue into an open-label extension study or enter the taper period with a final visit 1 week after the last dose.

Detailed description:
LGS poses a significant treatment challenge. No single antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Even with combination therapy, many LGS patients show resistance to treatment. Adjunctive therapy with newer anticonvulsant medications has demonstrated efficacy for some patients, although polytherapy and high medication doses are often associated with unfavorable adverse event profiles.

More effective and better-tolerated treatment options are needed for this population of medically intractable epilepsy patients. Clobazam may provide an improved safety profile compared to other AEDs currently approved for the treatment of LGS and may have less hypotonia and drooling effects than other benzodiazepines.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Clobazam Low Dose intervention 2: Clobazam Medium Dose intervention 3: Clobazam High Dose intervention 4: Placebo
Intervention descriptions: intervention 1: 0.25 mg/kg/day; tablets; orally; for 15-18 weeks intervention 2: 0.5 mg/kg/day; tablets; orally; for 15-18 weeks intervention 3: 1.0 mg/kg/day; tablets; orally; for 15-18 weeks intervention 4: tablets; orally; daily for 15-18 weeks

Protocol documents:
Clinical trial NCT00563381
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2008-01-01; Completion date: 2010-04-01
Enrollment: 7376 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomised, double-blind, double-dummy, multinational, multicentre, parallel group trial comparing tiotropium (18 mcg) inhalation capsule via HandiHaler and salmeterol (50 mcg) via MDI in patients with COPD. There will be a two-week run-in period followed by a 52-week randomised treatment phase. Patients who withdraw prematurely from trial medication will be encouraged to remain in the trial and participate in follow-up telephone contacts until their predicted normal exit date from the trial (i.e. 52 weeks after taking the first dose of randomised treatment). The phone calls will be made at all scheduled visits.

The primary objective of this study is to compare the effect of tiotropium (18 mcg) inhalation capsule via HandiHaler with that of salmeterol (50 mcg) via MDI on COPD exacerbations.

The primary endpoint is time to first COPD exacerbation during the 52 week randomised treatment period. A COPD exacerbation will be defined as a complex of respiratory events / symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnoea or chest tightness with at least one symptom lasting at least three days requiring treatment with antibiotics and/or systemic steroids and/or hospitalisation.

The onset of an exacerbation is defined as the onset of the first new or increased reported symptom. The end of the exacerbation should be recorded as defined by the investigator.

Only COPD exacerbations with onset during randomised treatment will be included in the analysis.

Detailed description:

Arms: arm 1: patients inhale Tiotropium 18mcg once daily via HandiHaler and Placebo MDI twice daily arm 2: patients inhale Salmeterol 50mcg twice daily via MDI and Placebo HandiHaler once daily
Interventions: intervention 1: Tiotropium bromide intervention 2: Salmeterol intervention 3: Placebo Salmeterol intervention 4: Placebo Tiotropium
Intervention descriptions: intervention 1: 18 mcg/daily intervention 2: 100 mcg/daily intervention 3: Placebo identical to Salmeterol device intervention 4: Placebo identical to Tiotropium device

Protocol documents:
Clinical trial NCT00713648
Conditions: Congenital Bleeding Disorder Congenital FXIII Deficiency
Sponsor: Novo Nordisk A/S
Start date: 2008-08-01; Completion date: 2010-04-01
Enrollment: 41 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: catridecacog
Intervention descriptions: intervention 1: 35 IU/kg body weight, i.v. administration, once every 4 weeks

Protocol documents:
Clinical trial NCT00847808
Conditions: Gastroesophageal Reflux
Keywords: Esophageal Reflux Gastro-Esophageal Reflux Gastroesophageal Reflux Disease GERD Regurgitation, Gastric Heartburn Drug Therapy
Sponsor: Takeda
Start date: 2009-02-01; Completion date: 2010-04-01
Enrollment: 178 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.

Detailed description:
Gastroesophageal reflux disease is recognized as a common and persistent medical problem in the US adult population. Gastroesophageal reflux disease comprises a spectrum of acid-related disorders including symptomatic nonerosive gastroesophageal reflux disease and erosive esophagitis. It affects men and women in nearly equal proportions, and the severity and intensity of heartburn symptoms may be similar in both types of patients.

Dexlansoprazole modified release is a dual delayed release formulation that consists of two types of granules contained in a single capsule. This dual delayed release formulation is designed to extend the duration of drug exposure and maintain pharmacologically active levels over a longer time period.

The purpose of this study is to demonstrate that participants with gastroesophageal reflux disease whose symptoms are well-controlled on twice daily proton pump inhibitors, remain well-controlled when switched to dexlansoprazole MR.

Arms: arm 1: None
Interventions: intervention 1: Dexlansoprazole MR QD
Intervention descriptions: intervention 1: Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.

Protocol documents:
Clinical trial NCT02441218
Conditions: Chronic Heart Failure
Sponsor: Institut de Recherches Internationales Servier
Start date: 2006-09-01; Completion date: 2010-04-01
Enrollment: 6505 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ivabradine intervention 2: Placebo
Intervention descriptions: intervention 1: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months. intervention 2: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.

Protocol documents:
Clinical trial NCT00002975
Conditions: Non-melanomatous Skin Cancer Precancerous Condition
Keywords: basal cell carcinoma of the skin squamous cell carcinoma of the skin actinic keratosis
Sponsor: Roswell Park Cancer Institute
Start date: 1997-02-01; Completion date: 2010-04-01
Enrollment: 180 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.

Detailed description:
OBJECTIVES:

* Determine the efficacy of aminolevulinic acid and laser irradiation in patients with superficial and nodular epidermally derived lesions.

OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma \[BCC\] vs nodular BCC vs superficial squamous cell carcinoma vs actinic keratoses). Individual lesions on patients within each stratum are randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).

ALA is topically applied in a cream mixture and an occlusive dressing is placed over the lesion. After the randomized duration of ALA application has expired, the dressing is removed and a dye laser is used to treat the lesion.

Patients are followed for 2-5 years after treatment.

PROJECTED ACCRUAL: Up to 200 patients could be accrued, assuming 1 lesion per patient. 50 lesions are required for each stratified group.

Arms: arm 1: 4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
Interventions: intervention 1: aminolevulinic acid
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00031694
Conditions: Acinar Cell Adenocarcinoma of the Pancreas Duct Cell Adenocarcinoma of the Pancreas Recurrent Pancreatic Cancer Stage III Pancreatic Cancer Stage IV Pancreatic Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2002-03-01; Completion date: 2010-04-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer.

II. To determine the toxicity of therapy. III. To determine patient survival after therapy. IV. To determine Bryostatin-1 pharmacokinetics.

OUTLINE: This is an open-label, multicenter study.

Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: paclitaxel intervention 2: bryostatin 1
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV

Protocol documents:
Clinical trial NCT00073307
Conditions: Carcinoma, Renal Cell
Keywords: Renal Cell Cancer (RCC) Cancer
Sponsor: Bayer
Start date: 2003-11-01; Completion date: 2010-04-01
Enrollment: 903 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate safety, efficacy (including quality of life), and pharmacokinetics of BAY43-9006 when added to Best Supportive Care in patients with unresectable and/or metastatic renal cell cancer, who have received one prior systemic regimen for advanced disease.

Detailed description:
Overall Survival (OS), Patient-reported outcome (PRO)

Arms: arm 1: Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted. arm 2: Placebo tablets matching in appearance were to be orally administered twice a day.
Interventions: intervention 1: Sorafenib (Nexavar, BAY43-9006) intervention 2: Placebo
Intervention descriptions: intervention 1: Multi Kinase Inhibitor intervention 2: Placebo

Protocol documents: