ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02092168
Conditions: Parkinson Disease
Keywords: Opicapone BIAL
Sponsor: Bial - Portela C S.A.
Start date: 2008-10-01; Completion date: 2009-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of age on the pharmacokinetic (PK) profile of BIA 9-1067 and its metabolites.

Detailed description:
Methodology:

Single-centre, open-label, parallel group, non-randomised multiple-dose 7-day study in 12 healthy elderly and 12 healthy younger male subjects.

Duration of treatment:

Each subject participated in the study for approximately 6 weeks. Participation included a screening evaluation within 28 days before inpatient period, a 12 day inpatient period and an end of study visit (ESV) 7 to 10 days after the discharge from the Unit.

The study design followed the recommendations of the CPMP/ICH/379/95 (ICH Topic E7) Note for Guidance on Studies in Support of Special Populations: Geriatrics, namely in the inclusion of subjects aged 65 years or older and contemplating single-dose and steady-state PK profiles. As the primary endpoint of the study was to characterize the pharmacokinetic profile of BIA 9-1067 and its metabolites in different parallel groups, there was no need to implement blinding procedures or to include a control group. Consequently, the trial was an open label study. Healthy subjects rather than patients with Parkinson's disease have been chosen as the study population, due to the lack of over-toxicity of the drug and an acceptable risk-benefit ratio. This allowed for a better interpretation of the study results, as there were no confounding factors resulting from changes in disease state and or concomitant medications.

The subjects were given a screening number after signing the informed consent by chronological order of inclusion in each group (young/elderly).

Arms: arm 1: BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days. arm 2: BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.
Interventions: intervention 1: BIA 9-1067
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02162979
Conditions: Parkinson's Disease
Keywords: Parkinson's disease PD dyskinesia treatment motor complications
Sponsor: Loma Linda University
Start date: 2002-02-01; Completion date: 2009-01-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease.

Detailed description:
Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease.
2. Age \> 40 years.
3. willingness and ability to comply with the study requirements and give informed consent.

Arms: arm 1: subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks. arm 2: subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.
Interventions: intervention 1: sildenafil intervention 2: Placebo
Intervention descriptions: intervention 1: sildenafil 50mg BID for 2 weeks intervention 2: None

Protocol documents:
Clinical trial NCT02169453
Conditions: Parkinson's Disease (PD)
Keywords: Parkinson's disease (PD) BIA 9-1067 Opicapone
Sponsor: Bial - Portela C S.A.
Start date: 2008-10-01; Completion date: 2009-01-01
Enrollment: 12 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 controlled-release levodopa/carbidopa 100/25 mg (Sinemet® CR 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® CR 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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 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 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 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

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.
Interventions: intervention 1: BIA 9-1067 intervention 2: Placebo intervention 3: Sinemet® CR 100/25
Intervention descriptions: intervention 1: OPC, Opicapone intervention 2: PLC, Placebo intervention 3: Controlled-release levodopa/carbidopa 100/25 mg

Protocol documents:
Clinical trial NCT02170519
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
Sponsor: Duke University
Start date: 2006-09-01; Completion date: 2009-01-01
Enrollment: 27 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Acute secondary pulmonary hypertension (PH) often leads to dysfunction of the right ventricle (RV) and can be a significant cause of patient morbidity and mortality. Selective pulmonary vasodilation with inhaled nitric oxide (INO) has become the treatment of choice for this condition. The evidence supporting INO safety and efficacy under these circumstances is sparse, however, and is largely extrapolated from the use of INO in neonatal pulmonary hypertension. Moreover, the high cost and potential toxicity of INO makes the therapy far from ideal. Emerging evidence suggests that inhaled aerosolized prostacyclins such as iloprost may be a favorable alternative therapy.

Detailed description:
Phase 1- In the original study, 3 doses of Iloprost were given. This was revised after 5 subjects were enrolled in order to study the effects of continuous delivery over a longer period of time.

Phase 2 - All remaining subjects received Iloprost as a continuous treatment.

The study was designed for an enrollment of 200 subjects and was ended early.

Arms: arm 1: Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy. arm 2: Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.

A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.
Interventions: intervention 1: Inhaled Iloprost
Intervention descriptions: intervention 1: A 20 mcg dose of Iloprost will be given initially.

Protocol documents:
Clinical trial NCT00058123
Conditions: Brain and Central Nervous System Tumors
Keywords: adult anaplastic astrocytoma adult mixed glioma adult anaplastic oligodendroglioma recurrent adult brain tumor adult anaplastic ependymoma
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2003-03-07; Completion date: 2009-01-02
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing.

PURPOSE: This phase II trial is studying how poly-ICLC works in treating patients with recurrent, progressive, or relapsed anaplastic glioma.

Detailed description:
OBJECTIVES:

* Determine the objective response rate in patients with recurrent or progressive anaplastic glioma treated with poly ICLC.
* Determine the efficacy of this drug, in terms of 6-month progression-free survival, in these patients.
* Determine the safety profile of this drug in these patients.
* Determine the survival of patients treated with this drug.
* Determine the tumor response rate in patients treated with this drug.
* Determine the biological effects of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive poly ICLC intramuscularly 3 times a week for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study.

Arms: arm 1: Poly-ICLC 20ug/kg 3 times a week 4 week cycles (Monday-Wednesday-Friday)

Intramuscular injection

Drug Poly-ICLC
Interventions: intervention 1: poly ICLC
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00568321
Conditions: Neuralgia, Postherpetic
Keywords: monoclonal antibody
Sponsor: Pfizer
Start date: 2007-12-19; Completion date: 2009-01-07
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the efficacy and safety of two doses levels of RN624 versus placebo for the relief of pain caused by post-herpetic neuralgia (PHN).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: RN624 intervention 2: RN624 intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mcg/kg intervention 2: 200 mcg/kg intervention 3: placebo

Protocol documents:
Clinical trial NCT00687271
Conditions: Hypercholesterolemia
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-14; Completion date: 2009-01-08
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to test the safety and effectiveness of MK-6213 as compared to MK-6213/Atorvastatin in participants 18 to 75 years) with high cholesterol.

Detailed description:

Arms: arm 1: 1 MK-6213 160-mg tablet co-administered orally with 1 Atorvastatin 20-mg tablet once daily for 4 weeks arm 2: 1 Atorvastatin 20-mg tablet co-administered orally with 1 tablet of placebo for MK-6312 once daily for 4 weeks arm 3: 1 MK-6213 160-mg tablet co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg once daily for 4 weeks arm 4: 1 tablet of placebo for MK-6213 160 mg co-administered orally with 1 tablet of placebo for Atorvastatin 20-mg tablet once daily for 4 weeks
Interventions: intervention 1: MK-6213 intervention 2: Atorvastatin calcium intervention 3: Placebo for MK-6312 160 mg intervention 4: Placebo for Atorvastatin 20 mg
Intervention descriptions: intervention 1: MK-6213 160 mg for 4 weeks. intervention 2: atorvastatin calcium 20mg for 4 weeks. intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00626366
Conditions: Chronic Sinusitis
Keywords: Nasal Spray Nasal Drop Intranasal Medication
Sponsor: University of Nebraska
Start date: 2008-03-12; Completion date: 2009-01-09
Enrollment: 18 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used.

Detailed description:
The purpose of this study is to determine the distribution of nasal sprays and nasal drops when used. The study hypothesizes that nasal drops will reach the frontonasal region more often than nasal sprays.

Arms: arm 1: This arm of the study will contain subjects who will spray 2-4 sprays of a nasal contrast solution in their nares. Following administration of the spray, the subjects will then have a Xoran mini-CAT scan of their sinuses. arm 2: This arm will contain subjects who will place two drops of a nasal contrast solution in each nose. Following administration of the nasal contrast, the subjects will then have a Xoran miniCAT scan of their sinuses.
Interventions: intervention 1: Sinus CT Scan intervention 2: Omnipaque 240 Contrast Solution intervention 3: Omnipaque 240 mg I/mL
Intervention descriptions: intervention 1: Subjects will undergo a Xoran miniCAT scan of their sinuses intervention 2: Subjects will spray 2-4 drops of half-strength Omnipaque 240 mgI/mL into each nare. Each spray is approximately 0.1 ml. intervention 3: Subjects will place two drops of half-strength Omnipaque 240 mg I/mL intranasally to each nose. Each drop is approximately 1 ml.

Protocol documents:
Clinical trial NCT00692003
Conditions: Epilepsy
Sponsor: Eisai Limited
Start date: 2008-08-01; Completion date: 2009-01-09
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Zonisamide is already marketed for the treatment of partial seizures in epilepsy. This study is intended to provide evidence that zonisamide is safe and effective in the treatment of primary generalised tonic-clonic seizures. The total trial duration will be 5.5-6.5 months. After that subjects who have completed the study will be eligible to enrol in an open-label extension study until zonisamide is marketed for this indication or further development in this indication stops. This extension study will be described in a separate protocol (E2090-E044-316).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Zonisamide intervention 2: Placebo
Intervention descriptions: intervention 1: 25-400 mg capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg; \>= 12 years old: 50 mg daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks) intervention 2: 25-400 mg Zonisamide Placebo capsules orally once daily in the evening.

Maximum study duration of 28 weeks comprising:

Baseline Period (Week-8/-4 to Week 0) no treatment

Titration Period (Week 0 to Week 4) \<12 years old: 1 mg/kg Zonisamide Placebo; \>= 12 years old: 50 mg Zonisamide Placebo capsules daily titrated weekly until a dose of 5 mg/kg or 300 mg was reached by Week 4

Maintenance Period (Week 4 to Week 16) dose from Week 4 to be maintained (4 mg/kg or 200 mg in the event of dose limiting adverse events)

Down Titration Period (4 weeks)

Protocol documents:
Clinical trial NCT00693472
Conditions: Akathisia, Drug-Induced Antipsychotic Agents Movement Disorders
Keywords: Antipsychotic Agents
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-08-15; Completion date: 2009-01-09
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the effectiveness of preladenant in the prevention (Part 1) or treatment (Part 2) of antipsychotic induced akathisia in participants with acute psychosis using the Barnes Akathisia Scale.

Detailed description:

Arms: arm 1: Preladenant 25 mg every 12 hours for 13 days arm 2: Placebo every 12 hours for 13 days arm 3: Preladenant 25 mg every 12 hours for 13 days arm 4: Anticholinergic agents or Propranolol as standard-of-care dosing regimen (supplied by the study site)
Interventions: intervention 1: Preladenant intervention 2: Placebo intervention 3: Anticholinergic agents or propanolol intervention 4: Haloperidol
Intervention descriptions: intervention 1: Preladenant, one 25 mg capsule, administered orally every 12 hours intervention 2: Matching placebo capsule administered orally every 12 hours intervention 3: Part 1 (as rescue therapy only): participants who develop akathisias may be treated with either anticholinergic agents or propranolol as a rescue medication at the discretion of the treating physician. Individual anticholinergic agents were not pre-specified per protocol.

Part 2 (standard of care): anticholinergic agents or propanolol at a dose determined by the investigator according to the local standard of care. Individual anticholinergic agents were not pre-specified per protocol. intervention 4: Participants continued pre-study haloperidol, admistered orally, at a dose of at least 7.5 mg/day

Protocol documents:
Clinical trial NCT00758784
Conditions: Dry Eye Disease
Sponsor: Bausch & Lomb Incorporated
Start date: 2008-08-13; Completion date: 2009-01-14
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.

Detailed description:

Arms: arm 1: bromfenac ophthalmic solution 0.06% bilaterally twice a day
Interventions: intervention 1: bromfenac ophthalmic solution 0.06%
Intervention descriptions: intervention 1: bromfenac ophthalmic solution 0.06% bilaterally twice a day

Protocol documents:
Clinical trial NCT00734032
Conditions: Atherosclerosis
Keywords: SB-480848 Dyslipidaemia
Sponsor: GlaxoSmithKline
Start date: 2008-08-26; Completion date: 2009-01-16
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to examine the effects of SB-480848 on plasma lipoprotein associated phospholipase A2 (Lp-PLA2) activity in dyslipidemic patients during a 4-week treatment with SB-480848.

Detailed description:

Arms: arm 1: Matched Placebo arm 2: SB480848 40mg/day arm 3: SB480848 80mg/day arm 4: SB480848 160mg/day
Interventions: intervention 1: SB480848 40mg EC Tablet intervention 2: SB480848 80mg EC Tablet intervention 3: SB480848 160mg EC Tablet intervention 4: SB480848 Placebo Tablet
Intervention descriptions: intervention 1: 1 tablet once a day intervention 2: 1 tablet once a day intervention 3: 1 tablet once a day intervention 4: 1 tablet once a day

Protocol documents:
Clinical trial NCT00768521
Conditions: Overactive Bladder
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-03; Completion date: 2009-01-19
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will design an alternative urodynamic platform to better evaluate treatment effects of medications for overactive bladder. Part II is dependent on results of Part I and may not be conducted.

Detailed description:

Arms: arm 1: Part I, Sequence 1: tolterodine tartrate crossing over to matching placebo arm 2: Part I, Sequence 2: placebo crossing over to study drug 4 mg once a Day (qd) arm 3: Part II, Sequence 1: study drug crossing over to placebo arm 4: Part II, Sequence 2: placebo crossing over to study drug
Interventions: intervention 1: tolterodine tartrate intervention 2: Comparator: Placebo to tolterodine tartrate
Intervention descriptions: intervention 1: Part I: tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose tolterodine tartrate 4 mg capsule intervention 2: Part I: placebo to tolterodine tartrate 4 mg capsule once a day (qd) for 7 days

Part IIa: placebo to tolterodine tartrate 4 mg capsule qd for 7 days

Part IIb: single dose placebo to tolterodine tartrate 4 mg capsule

Protocol documents:
Clinical trial NCT00640146
Conditions: Opioid-induced Constipation
Sponsor: Bausch Health Americas, Inc.
Start date: 2007-10-19; Completion date: 2009-01-21
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.

Detailed description:
This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those participants who meet all eligibility requirements will be enrolled in the study. Treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. Originally, participants were receiving treatment for up to 7 days. Then after Protocol Amendment 1 (12 March 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days".

Arms: arm 1: Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled. arm 2: Participants will receive placebo matching to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled.
Interventions: intervention 1: Methylnaltrexone bromide intervention 2: Placebo
Intervention descriptions: intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arm. intervention 2: Placebo matching to methylnaltrexone will be administered as per the dose and schedule specified in the respective arm.

Protocol documents:
Clinical trial NCT00319696
Conditions: Digital Ulcers
Keywords: digital ulcers systemic sclerosis finger ulcers bosentan open label
Sponsor: Actelion
Start date: 2004-07-08; Completion date: 2009-01-22
Enrollment: 116 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The aim of the study is to collect long-term efficacy, tolerability and safety data of bosentan in Systemic Sclerosis (SSc) patients suffering from ischemic digital ulcers (DUs).

Detailed description:

Arms: arm 1: Bosentan 62.5 mg tablets b.i.d. for the first 4 weeks followed by bosentan 125 mg b.i.d. thereafter
Interventions: intervention 1: Bosentan 62.5 mg intervention 2: Bosentan 125 mg
Intervention descriptions: intervention 1: Bosentan 62.5-mg oral tablets twice daily (b.i.d.) for 4 weeks (initial dose) intervention 2: Bosentan 125-mg oral tablets administered b.i.d. (target dose)

Protocol documents: