ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01369225
Conditions: Alzheimer's Disease
Keywords: Randomized Safety Study Open Label
Sponsor: Pfizer
Start date: 2011-07-01; Completion date: 2014-08-01
Enrollment: 52 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to evaluate the safety and tolerability of multiple doses of AAB-003 (PF-05236812) in patients with mild to moderate Alzheimer's Disease. Patients who complete study B2601001 may participate in this trial and receive AAB-003 (PF-05236812). Each patient's participation will last approximately 52 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: AAB-003 (PF-05236812) intervention 2: AAB-003 (PF-05236812) intervention 3: AAB-003 (PF-05236812) intervention 4: AAB-003 (PF-05236812) intervention 5: AAB-003 (PF-05236812)
Intervention descriptions: intervention 1: 0.5 mg/kg AAB-003, IV intervention 2: 1 mg/kg AAB-003, IV intervention 3: 2 mg/kg AAB-003, IV intervention 4: 4 mg/kg AAB-003, IV intervention 5: 8 mg/kg AAB-003, IV

Protocol documents:
Clinical trial NCT01393106
Conditions: Hodgkin Lymphoma
Keywords: HL idelalisib CAL-101 GS-1101 PI3K
Sponsor: Gilead Sciences
Start date: 2011-09-01; Completion date: 2014-08-01
Enrollment: 25 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of idelalisib in participants with relapsed of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall response rate.

Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable toxicity.

Detailed description:

Arms: arm 1: Participants will receive up to 300 mg of idelalisib twice daily.
Interventions: intervention 1: Idelalisib
Intervention descriptions: intervention 1: Idelalisib tablets administered orally

Protocol documents:
Clinical trial NCT01411228
Conditions: Gaucher Disease
Keywords: Gaucher disease pediatrics
Sponsor: Pfizer
Start date: 2011-09-01; Completion date: 2014-08-01
Enrollment: 15 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to \<18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols PB-06-002 (switchover study from imiglucerase) or PB-06-005 (naïve treatment with taliglucerase alfa).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Taliglucerase alfa
Intervention descriptions: intervention 1: Taliglucerase alfa for infusion every two weeks for 24 months

Protocol documents:
Clinical trial NCT01441596
Conditions: Breast Neoplasms Neoplasm Metastasis
Sponsor: Boehringer Ingelheim
Start date: 2011-10-01; Completion date: 2014-08-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to investigate the efficacy and safety of afatinib alone or in combination with vinorelbine, as treatment in patients with HER2-overexpressing metastatic breast cancer, who have progressive brain lesions after trastuzumab and/or lapatinib based therapy

Detailed description:

Arms: arm 1: Afatinib monotherapy: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg. arm 2: Afatinib 40 mg per day, continuous treatment, in combination with vinorelbine Vinorelbine 25 mg/mÂ² on days 1, 8, 15 in a 3-weekly course. arm 3: Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
Interventions: intervention 1: Vinorelbine intervention 2: Investigator's choice of treatment intervention 3: afatinib intervention 4: afatinib
Intervention descriptions: intervention 1: Vinorelbine 25 mg/mÂ² on days 1, 8, 15 in a 3-weekly course intervention 2: Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines. intervention 3: Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg. intervention 4: Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.

Protocol documents:
Clinical trial NCT01455194
Conditions: Bronchial Asthma
Keywords: ciclesonide asthma
Sponsor: AstraZeneca
Start date: 2011-11-01; Completion date: 2014-08-01
Enrollment: 520 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the trial is to investigate asthma control with 160 to 640 mcg ciclesonide/day. Asthma control will be assessed by the Asthma Control Questionnaire (ACQ).

Detailed description:

Arms: arm 1: Two puffs of 40 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 160 mcg) arm 2: Two puffs of 80 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 320 mcg) arm 3: Two puffs of 160 mcg ciclesonide inhaled in the morning and the evening (corresponding to a total daily dose of 640 mcg)
Interventions: intervention 1: Ciclesonide
Intervention descriptions: intervention 1: During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)

Protocol documents:
Clinical trial NCT01470859
Conditions: Idiopathic Parkinson's Disease
Keywords: De Novo parkinson's disease initial treatment pramipexole Levodopa Parkinson's disease-related spatial covariance pattern
Sponsor: Huashan Hospital
Start date: 2011-12-01; Completion date: 2014-08-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Levodopa and non-ergot dopaminergic agonists such as pramipexole are both recommended as the first-line symptomatic treatment for early untreated Parkinson's disease (PD), previous clinical trial indicated that initial pramipexole owns advantage over levodopa regarding motor complications, on the contrary, less adverse effect like freezing and severe somnolence favors initial treatment of levodopa. Thus, it remains controversial that initiation of which medication will be better for those patients with early PD.

Parkinson's disease-related spatial covariance patter (PDRP) is a new biomarker which can represent the network activity of brain and severity of PD. Based on the literatures and our previous data, the investigators hypothesize that PDRP will be served as a biomarker to help us evaluate and compare the effect of levodopa or pramipexole on the progression of PD, which might be able to provide further evidence for clinicians to address the above critical issue.

Detailed description:
CALM-PD study found that Pramipexole can reduce the occurrence of motor complication compared with Levodopa used as initiative treatment, but it still remains debatable that initiation of which medication will be better for those patients with De Novo PD.

PDRP (Parkinson's disease-related spatial covariance pattern) is a biomarker which can represent the network activity of cortico-striato-pallido-thalamocortical pathways and highly reproducible with stable network activity in individual subjects. The study published in "J Neuroscience" in 2010 showed that the abnormal PDRP antecede the appearance of motor signs by about 2 years, indicating PDRP might be a very promising biomarker for identifying PD at its early stage. Moreover, PDRP is able to represent the progression and severity of PD as well. It was reported that Levodopa can reduce the PD-related network activity, and the degree of network suppression correlates with the clinical improvement. However, there is no study currently showing the impact of pramipexole on brain PDRP network compared with levodopa as initiative treatment.

Arms: arm 1: 0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients arm 2: Sinemet CR CR， Controlled Release
Interventions: intervention 1: pramipexole intervention 2: Sinemet CR
Intervention descriptions: intervention 1: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year. intervention 2: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year

Protocol documents:
Clinical trial NCT01482910
Conditions: Macular Degeneration
Sponsor: Bayer
Start date: 2011-12-01; Completion date: 2014-08-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the efficacy and safety of intravitreally (IVT), i.e. directly into the eye administered VEGF Trap-Eye compared with photodynamic therapy (PDT) on visual function in Chinese subjects with age-related neovascular or "wet" age-related macular degeneration.

Subjects will be randomized in a 3:1 ratio to either receive VEGF Trap-Eye or PDT. Both treatment groups will receive the other treatment as a sham procedure.

Detailed description:
Adverse events collection will be covered in Adverse Events section.

Arms: arm 1: Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. arm 2: Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
Interventions: intervention 1: Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321) intervention 2: Visudyne
Intervention descriptions: intervention 1: Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed. intervention 2: Participants in the PDT group (Visudyne group) received Visudyne as needed. Additionally, sham IVT injections was administered until week 28. Thereafter, subjects in the PDT group received active (= no sham) VEGF Trap-Eye treatment until week 48.

Protocol documents:
Clinical trial NCT01496469
Conditions: Hypertension
Keywords: Drug Therapy
Sponsor: Takeda
Start date: 2012-02-01; Completion date: 2014-08-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of febuxostat, once daily (QD), compared to placebo on lowering ambulatory 24-hour mean blood pressure of participants with hypertension and hyperuricemia (not associated with gout).

Detailed description:
This study is designed to evaluate the effect of febuxostat during 6 weeks of treatment.

Arms: arm 1: Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks. arm 2: Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.
Interventions: intervention 1: Febuxostat intervention 2: Placebo
Intervention descriptions: intervention 1: Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks intervention 2: Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.

Protocol documents:
Clinical trial NCT01503749
Conditions: Liver Cirrhosis
Sponsor: Seoul National University Hospital
Start date: 2012-01-01; Completion date: 2014-08-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The investigators aim to investigate the safety and efficacy of peripheral blood monocyte for the treatment of patients with advanced liver cirrhosis.

Detailed description:
G-colony stimulating factor(5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis. On the day 4th, plasmapheresis will be done to collect peripheral blood mononucleated cells

. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.

Arms: arm 1: Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells. arm 2: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. arm 3: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells

. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
Interventions: intervention 1: G-colony stimulating factor intervention 2: Infusion of the mobilized monocyte cells
Intervention descriptions: intervention 1: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm. intervention 2: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.

Protocol documents:
Clinical trial NCT01510158
Conditions: Gout
Sponsor: Ardea Biosciences, Inc.
Start date: 2012-01-01; Completion date: 2014-08-01
Enrollment: 607 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study that compare the serum uric acid lowering effects, clinical benefits, and safety of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who have had an inadequate response to allopurinol.

Detailed description:
Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients treated with allopurinol do not achieve the recommended serum urate (sUA) target of \< 6.0 mg/dL and need additional therapy to achieve the target. Probenecid and benzbromarone are uric acid transporter 1 (URAT1) inhibitors, generally recommended as second-line agents for patients who are either resistant to or intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid is rarely used. Consequently, there is a clear unmet medical need for a new safe and effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in combination with allopurinol in patients not responding adequately to allopurinol monotherapy so that very high rates of response can be achieved by nearly all gout patients, rather than a minority.The subjects selected for this study will have moderate to severe gout with an inadequate response to allopurinol

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lesinurad intervention 2: Lesinurad intervention 3: Placebo intervention 4: Allopurinol intervention 5: Allopurinol intervention 6: Allopurinol
Intervention descriptions: intervention 1: Tablets, 200 mg once daily (qd) intervention 2: Tablets, 400 mg qd intervention 3: Tablets, Placebo qd intervention 4: Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment) intervention 5: Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment) intervention 6: Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)

Protocol documents:
Clinical trial NCT01526356
Conditions: Angiofibromas Tuberous Sclerosis
Keywords: Angiofibroma Tuberous Sclerosis Rapamycin Sirolimus mTOR
Sponsor: The University of Texas Health Science Center, Houston
Start date: 2012-05-01; Completion date: 2014-08-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with Tuberous Sclerosis Complex (TSC). Subjects will apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to their angiofibromas for six months.

The primary goal of this study is to evaluate the efficacy of the topical medication for reduction of cutaneous angiofibromas in patients with TSC. The secondary goal of this study is to confirm the safety of the topical medication.

Detailed description:

Arms: arm 1: Cream only arm 2: 0.1% Rapamycin cream arm 3: 1% Rapamycin cream
Interventions: intervention 1: Placebo intervention 2: Rapamycin intervention 3: Rapamycin
Intervention descriptions: intervention 1: Study cream is applied nightly to the affected areas on the face. intervention 2: Study cream is applied nightly to the affected areas on the face. Low Dose intervention 3: Study cream is applied nightly to the affected areas on the face. High Dose

Protocol documents:
Clinical trial NCT01528891
Conditions: Tonsillectomy
Keywords: tonsillectomy emergence agitation
Sponsor: Peter Davis
Start date: 2012-01-01; Completion date: 2014-08-01
Enrollment: 418 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.

Detailed description:

Arms: arm 1: Dexmedetomidine arm 2: Normal saline
Interventions: intervention 1: Dexmedetomidine intervention 2: Placebo
Intervention descriptions: intervention 1: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery intervention 2: None

Protocol documents:
Clinical trial NCT01554982
Conditions: End Stage Renal Disease Kidney Failure Renal Failure Hyperphosphatemia ESRD
Keywords: Participation Limited Long Term Safety Extension
Sponsor: Keryx Biopharmaceuticals
Start date: 2012-08-01; Completion date: 2014-08-01
Enrollment: 168 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A long-term safety study of ferric citrate (KRX-0502) in renal failure patients who have completed study KRX-0502-304. Only patients who participated in the KRX-0502-304 trial may participate in this trial.

Detailed description:
This study was an open-label, 48-week safety extension of Study KRX-0502-304 (Study 304), to evaluate the safety of long-term use of KRX-0502 in subjects with ESRD for up to 2 years of cumulative exposure. Subjects who completed the Safety Assessment Period (SAP) and, if eligible, the Efficacy Assessment Period (EAP) of Study 304, independent of their assigned treatment arm in the SAP or EAP of Study 304, were eligible for participation in this long-term safety extension study. No new subjects were permitted to enter this study.

Arms: arm 1: Open label extension of those completing study KRX-0304
Interventions: intervention 1: ferric citrate
Intervention descriptions: intervention 1: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.

Protocol documents:
Clinical trial NCT01555983
Conditions: Spinal Cord Injuries Spinal Cord Diseases
Keywords: cannabis central neuropathic pain analgesia
Sponsor: Barth Wilsey
Start date: 2012-07-01; Completion date: 2014-08-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured.

Detailed description:
This study will demonstrate that vaporized cannabis can produce antinociceptive effects compared to placebo in human subjects with spinal cord injury (SCI). A within-subject crossover study of the effects of cannabis versus placebo on spontaneous and evoked pain will be performed. A synopsis of antinociception with mood, cognitive impairment, psychomotor performance, and side effects will be obtained to help evaluate the utility of vaporized marijuana in SCI neuropathic pain.

This study will compare the analgesic and side effect profile of low (3.5%) to high dose (7.0%) delta 9-tetrahydrocannabinol in subjects with spinal cord injury pain. It is hypothesized that a low dose will produce a lesser degree of neuropsychological impairment while maintaining a similar degree of pain relief to the higher dose. The use of two different strengths will help determine tolerable dosing for the treatment of SCI neuropathic pain.

Arms: arm 1: Inhaling of standardized measured puffs of Vaporized High Dose 6.7% THC. Monitored for 8 hours measuring psychoactive and analgesic effects. arm 2: Inhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects. arm 3: Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Interventions: intervention 1: Vaporization of Cannabis
Intervention descriptions: intervention 1: Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC

Protocol documents:
Clinical trial NCT01560585
Conditions: Alzheimer's Disease
Keywords: Isotretinoin Alzheimer's disease Dementia Retinoid
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2012-04-01; Completion date: 2014-08-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label study of isotretinoin, a medication which is FDA approved for treatment of other conditions to determine initial safety in Alzheimer's disease.

Detailed description:
Retinoids have some relevant characteristics that could be considered useful in treating AlZheimer's disease. These include anti-inflammatory properties, possible anti-amyloid formation proeprties and inhibition of cell cycle properties

Arms: arm 1: All participants will receive Isotretinoin for 24 weeks
Interventions: intervention 1: Isotretinoin
Intervention descriptions: intervention 1: Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks

Protocol documents: