ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01455220
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Sexual Dysfunction Quality of Life
Sponsor: University of South Florida
Start date: 2011-01-01; Completion date: 2014-10-01
Enrollment: 45 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if sexual dysfunction symptoms and quality of life measures in patients with Multiple Sclerosis may be improved in patients that are prescribed Tysabri.

Detailed description:
Patients will be naive to Tysabri at the baseline for this study then their sexual dysfunction, fatigue, and quality of life measures will be measured using scaled questionnaires.

Interventions: intervention 1: Tysabri ® (Natalizumab)
Intervention descriptions: intervention 1: IV, monthly

Protocol documents:
Clinical trial NCT01461551
Conditions: Anesthesia
Keywords: troponin I creatine kinase mb hospital days lymphocyte apoptosis intensive care unit days
Sponsor: Ruijin Hospital
Start date: 2011-10-01; Completion date: 2014-10-01
Enrollment: 105 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Most researches revealed that volatile anesthetic sevoflurane has a more marked cardioprotective effect against ischemia compared with intravenous agent propofol.However, propofol has been suggested to be more benefit for attenuation of surgery-induced immunosuppression.Thus, the aim of this study was to investigate under the specific OPCAB surgical stress, the influence of 3 established anesthetic techniques: sevoflurane, propofol and combine of sevoflurane and propofol maintained anesthesia on the apoptosis of circulating lymphocytes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Sevoflurane intervention 2: Propofol intervention 3: combine of sevoflurane and propofol
Intervention descriptions: intervention 1: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration) intervention 2: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion) intervention 3: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)

Protocol documents:
Clinical trial NCT01475851
Conditions: Hepatitis B, Chronic
Keywords: Tenofovir disoproxil fumarate, compensated chronic hepatitis B
Sponsor: GlaxoSmithKline
Start date: 2011-12-01; Completion date: 2014-10-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in Japanese patients with compensated chronic hepatitis B with poor response to other drugs.

Detailed description:
This is a multicenter, open-label study in Japanese patients with compensated chronic hepatitis B with poor response to other drugs in order to evaluate the efficacy and safety of GSK548470 administered at a dose of 300 mg once daily. The target sample size is set at 32 subjects. The primary objective is to evaluate the efficacy and safety of once-daily treatment with GSK548470 300 mg in subjects with compensated chronic hepatitis B with poor response to other drugs. The secondary objective is to evaluate the long-term efficacy and safety of once-daily treatment with GSK548470 300 mg.To evaluate the efficacy and safety of GSK548470 in the study, subjects receiving a combination of lamivudine (LAM) and adefovir pivoxil (ADV) will be switched to a combination of LAM and GSK548470, while subjects on entecavir hydrate (ETV) with or without ADV will be switched to a combination of ETV and GSK548470.

Arms: arm 1: GSK548470 300 mg tablet is administered orally once daily
Interventions: intervention 1: GSK548470 300 mg tablet
Intervention descriptions: intervention 1: Blue tablets containing 300 mg of tenofovir disoproxil fumarate

Protocol documents:
Clinical trial NCT01492686
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Keywords: Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2011-12-01; Completion date: 2014-10-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to confirm the efficacy of 60 mg of MCI-186 via intravenous drip infusion once a day in the patients with ALS based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind, placebo-controlled manner. The study is also to examine the safety of MCI-186 to the ALS patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-186 intervention 2: Placebo intervention 3: MCI-186 in open label phase
Intervention descriptions: intervention 1: Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). intervention 2: Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles). intervention 3: All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.

Protocol documents:
Clinical trial NCT01523301
Conditions: Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro Depressive Symptom Idiopathic Parkinson's disease
Sponsor: UCB Korea Co., Ltd.
Start date: 2012-04-01; Completion date: 2014-10-01
Enrollment: 380 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to show superiority of Rotigotine over placebo on improvement of depressive symptoms in subjects with idiopathic Parkinson's disease.

Detailed description:
The study included a maximum 2-week Screening Period, a maximum 4-week Titration Period for early-stage Parkinson's disease or maximum 7-week Titration Period for advanced-stage Parkinson's disease, 8-week Maintenance Period, a maximum 6-day De-escalation Period for early-stage Parkinson's disease or maximum 12-day De-escalation Period for advanced-stage Parkinson's disease and 30-day Safety Follow-Up Period.

The maximum study durations for an individual subject with early-stage Parkinson's disease and with advanced-stage Parkinson's disease were 19 weeks and 23 weeks, respectively.

Arms: arm 1: Rotigotine, daily doses, treatment group arm 2: Placebo, daily doses, placebo group
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Transdermal Patch

Content:

2 mg /24 h (10 cm\^2), 4 mg /24 h (20 cm\^2), 6 mg /24 h (30 cm\^2), 8 mg /24 h (40 cm\^2)

* For early-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 8 week Maintenance period
* For advanced-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 8 week Maintenance period intervention 2: Transdermal Patch

Size:

10 cm\^2, 20 cm\^2, 30 cm\^2, 40 cm\^2

Subjects randomized to placebo received matching placebo patches

Protocol documents:
Clinical trial NCT01525628
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2012-04-01; Completion date: 2014-10-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the drug-drug interactions between BI 201335 and BI 207127 as well as their combined effect on CYP probe drug substrates and on tenofovir and raltegravir in treatment naive or prior treatment relapse patients with chronic hepatitis C infection.

Detailed description:

Arms: arm 1: Effect of BI 207127 on BI 201335, the effect of BI 201335 and dual oral direct acting antiviral (DAAs) on caffeine, tolbutamide and midazolam arm 2: Effect of BI 201335 on BI 207127, the effect of BI 207127 and metabolites and dual oral DAAs on caffeine, tolbutamide and midazolam arm 3: Effect of Dual oral DAAs on tenofovir arm 4: Effect of BI 201335 and BI 207127 at 600 mg b.i.d. on caffeine, tolbutamide and midazolam arm 5: Effect of BI 201335 and BI 207127 on raltegravir
Interventions: intervention 1: midazolam intervention 2: BI 201335 intervention 3: tenofovir intervention 4: caffeine intervention 5: tolbutamide intervention 6: tolbutamide intervention 7: midazolam intervention 8: caffeine intervention 9: pegylated interferon intervention 10: BI 201335 intervention 11: BI 201335 intervention 12: BI 207127 intervention 13: BI 207127 intervention 14: BI 201335 intervention 15: BI 207127 intervention 16: ribavirin intervention 17: ribavirin intervention 18: ribavirin intervention 19: pegylated interferon intervention 20: ribavirin intervention 21: caffeine intervention 22: tolbutamide intervention 23: BI 207127 intervention 24: midazolam intervention 25: BI 201335 intervention 26: BI 207127 intervention 27: ribavirin
Intervention descriptions: intervention 1: CYP3A probe drug intervention 2: HCV protease inhibitor intervention 3: nucleoside analogue intervention 4: CYP1A2 probe drug intervention 5: CYP2C9 probe drug intervention 6: CYP2C9 probe drug intervention 7: CYP3A probe drug intervention 8: CYP1A2 probe drug intervention 9: HCV treatment intervention 10: HCV protease inhibitor intervention 11: HCV protease inhibitor intervention 12: HCV polymerase inhibitor intervention 13: HCV polymerase inhibitor intervention 14: HCV protease inhibitor intervention 15: HCV polymerase inhibitor intervention 16: HCV treatment intervention 17: HCV treatment intervention 18: HCV treatment intervention 19: HCV treatment intervention 20: HCV treatment intervention 21: CYP1A2 probe drug intervention 22: CYP2C9 probe drug intervention 23: HCV polymerase inhibitor intervention 24: CYP3A probe drug intervention 25: HCV protease inhibitor intervention 26: HCV polymerase inhibitor intervention 27: HCV treatment

Protocol documents:
Clinical trial NCT01540513
Conditions: Glioblastoma Multiforme Brain Metastases
Sponsor: University of Wisconsin, Madison
Start date: 2012-03-01; Completion date: 2014-10-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating tumor dosimetry. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404

Detailed description:

Arms: arm 1: injection of I-124NM404 for imaging
Interventions: intervention 1: NM404 intervention 2: NM404
Intervention descriptions: intervention 1: injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging

Other Names:

PET imaging with I-124 NM404 intervention 2: injection of an experimental imaging agent, 5mCi I-124NM404

Protocol documents:
Clinical trial NCT01543568
Conditions: Age Related Macular Degeneration
Keywords: Age related Macular Degeneration Recalcitrant Age Related Macular Degeneration
Sponsor: David M. Brown, M.D.
Start date: 2012-02-01; Completion date: 2014-10-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
50 Patients with recalcitrant exudative age-related macular degeneration with a history of retinal or subretinal fluid after multiple intravitreal injections with ranibizumab 0.5mg and subsequently treated with ranibizumab 2.0mg, who are incomplete responders to 2.0mg of ranibizumab.

Detailed description:
The rationale for the TURF trial is based on the greater binding affinity of VEGF Trap-eye, which theoretically may prove to be more effective for recalcitrant wet AMD and therefore may demonstrate a positive impact on visual acuity and the foveal anatomy of subjects who have a history of a less than optimal anatomical and visual response to multiple intravitreal injections of 2.0mg (super-dose) ranibizumab. Based on the anatomical data from the VIEW1 and VIEW2 trials, approximately 70% of VEGF-Trap eye patients had no evidence of fluid on OCT compared to approximately 55% of ranibizumab patients. One potential interpretation of this clinical data is that the increased binding affinity and longer half-life of VEGF-Trap eye result in the resolution of more fluid for a longer duration of effect.

Patients to be enrolled in this study have a history of requiring monthly dosing of ranibizumab 2.0mg to achieve maximum resolution of fluid on OCT and increased visual acuity. These patients initially showed minimal fluid resolution visual acuity gains while treated with Lucentis (0.5mg ranibizumab) and were subsequently treated with 2.0mg monthly. It is expected that treating these same patients with 2.0mg EYLEA™ (aflibercept injection for eye) will maintain the fluid resolution on OCT and visual acuity gains previously requiring a super-dose of ranibizumab.

Arms: arm 1: open label, Subjects seen monthly \& given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)
Interventions: intervention 1: aflibercept 2.0 mg
Intervention descriptions: intervention 1: Intravitreal aflibercept injection 2.0 mg

Protocol documents:
Clinical trial NCT01559844
Conditions: Hepatitis C Hepatocellular Carcinoma
Keywords: Hepatitis Chronic hepatocellular carcinoma HCC transplant
Sponsor: Gilead Sciences
Start date: 2012-03-01; Completion date: 2014-10-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to determine if the administration of a combination of sofosbuvir (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior to undergoing liver transplantation could prevent post-transplant re-infection as determined by a sustained post-transplant virological response (HCV RNA \< LLoQ) at 12 weeks post-transplant.

Participants will enroll in the pretransplant treatment phase (24 or 48 weeks). Participants enrolling for 24 weeks in the pretransplant treatment phase may receive treatment for up to an additional 24 weeks in the pretransplant retreatment phase. Participants enrolling for 48 weeks in the pretransplant treatment will have a second baseline at Week 24 for combined analysis in the pretransplant retreatment phase.

Participants who undergo liver transplant will stop all study drug 24 hours prior to transplant, and enter a 48-week follow-up phase to monitor for recurrent HCV infection.

Detailed description:

Arms: arm 1: Sofosbuvir plus ribavirin for up to 48 weeks or until time of transplant, whichever occurs first.
Interventions: intervention 1: Sofosbuvir intervention 2: Ribavirin
Intervention descriptions: intervention 1: Sofosbuvir 400 mg (2 x 200 mg tablets) administered orally once daily intervention 2: Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol documents:
Clinical trial NCT01565148
Conditions: Diabetic Macular Edema
Keywords: Diabetic Macular Edema (DME)
Sponsor: Johns Hopkins University
Start date: 2012-02-01; Completion date: 2014-10-01
Enrollment: 185 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
* To assess the safety of repeated iCo-007 intravitreal injections in treatment of subjects with diabetic macular edema as monotherapy and in combination with ranibizumab or laser photocoagulation
* To assess the change in visual acuity and retinal thickness on optical coherence tomography (OCT) from baseline to month 8 and month 12

Detailed description:

Arms: arm 1: Drug: iCo-007 350 mcg

iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4 arm 2: Drug: iCo-007 700 mcg

iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 arm 3: Drug: iCo-007 350 mcg and Laser

iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation arm 4: Drug: Ranibizumab and iCo-007 350 mcg

Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
Interventions: intervention 1: iCo-007 350 mcg intervention 2: iCo-007 700 mcg intervention 3: iCo-007 350 mcg and Laser intervention 4: Ranibizumab and iCo-007 350 mcg
Intervention descriptions: intervention 1: iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4 intervention 2: iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4 intervention 3: iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation intervention 4: Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later

Protocol documents:
Clinical trial NCT01580020
Conditions: Retinal Vein Occlusion
Keywords: Macular Degeneration Macular Edema Retinal Vein Occlusion Choroidal Neovascularization Signs and Symptoms Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis Sensation Disorders Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate BB 1101 Anti-Inflammatory Agents Therapeutic Uses Vision, Low Signs Vision Disorders
Sponsor: Novartis Pharmaceuticals
Start date: 2012-05-01; Completion date: 2014-10-01
Enrollment: 175 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is intended to characterize the clinical benefit regarding safety and efficacy of a long term treatment with Lucentis in comparison with Ozurdex over an additional 6 months and a 3-month follow-up period, following the initial 6-month treatment in the respective core studies CRFB002EDE17 (NCT01396057) and CRFB002EDE18 (NCT01396083).

Detailed description:

Arms: arm 1: The PRN injection scheme applied in the core study will also be followed during this extension study:

Patients should be monitored monthly (starting at V1E) for VA and treatment is to be resumed when monitoring indicates loss of VA due to disease activity. Monthly injections should then be administered until stable VA is reached again for 3 consecutive monthly assessments (implying a minimum of 2 injections during stable VA). The interval between 2 doses should not be shorter than 1 month arm 2: A PRN re-treatment scheme will be applied for the Ozurdex arm during this extension study, i.e. patients may receive an implant at V1E or later as needed: Patients should be monitored monthly and if there is a decline from stable VA stability due to macular edema patients will receive another intravitreal implant. (700 µg; long acting release (LAR)) given that in the opinion of the investigator the patient would benefit from the re-treatment. However, a minimum period of 5 months in between implantations is required.
Interventions: intervention 1: RFB002 intervention 2: Dexamethasone
Intervention descriptions: intervention 1: 0.5 mg/0.05 mL solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20. intervention 2: Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; Dexamethasone was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility

Protocol documents:
Clinical trial NCT01587001
Conditions: Pulmonary Sarcoidosis
Keywords: Sarcoidosis oxidative stress anti-oxidant
Sponsor: National Jewish Health
Start date: 2011-11-01; Completion date: 2014-10-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis.

Detailed description:
Sarcoidosis is a granulomatous lung disease predominantly affecting the lungs. Reactive oxidative species are produced secondary to oxidative stress and inflammation and can affect key cellular processes. The investigators have shown a role for oxidative stress in chronic beryllium disease (CBD), a granulomatous disease that resembles sarcoidosis, and have also shown that antioxidant therapy reduces inflammation in CBD. Oxidative stress also plays a role in sarcoidosis but the exact mechanism and potential effect of antioxidant therapy on sarcoidosis is unknown. The investigators propose conducting a pilot study investigating the effect of an antioxidant, N-Acetyl-L-Cysteine (NAC), on inflammation and oxidative stress in sarcoidosis. The investigators will measure and compare markers of inflammation and oxidative stress in the lungs of sarcoidosis patients before and after treatment with NAC. The results of this study will prepare the investigators for a larger study investigating the role of NAC as a therapy for sarcoidosis with changes in lung function and x-ray as our primary outcome. This will provide the investigators with a new non-toxic therapy for sarcoidosis that can be used on its own or to supplement other therapies minimizing their toxicity.

Arms: arm 1: oral NAC 900mg three times daily for 8 weeks arm 2: oral placebo three times daily for 8 weeks
Interventions: intervention 1: N-acetyl-cysteine intervention 2: Placebo
Intervention descriptions: intervention 1: 900mg three times daily for 8 weeks intervention 2: Matching placebo three times daily for 8 weeks.

Protocol documents: