ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01485094
Conditions: Neuralgia
Keywords: neuralgia postherpetic
Sponsor: Grünenthal GmbH
Start date: 2012-02-01; Completion date: 2013-01-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to determine whether a novel analgesic is effective in treating of neuropathic pain caused by herpetic infection, surgery, or trauma.

Detailed description:
This trial evaluates the effectiveness of a novel analgesic in peripheral neuropathic pain in a mixed patient population. Participants were treated for one week and randomly assigned to the novel analgesic, pregabalin, or placebo. Pain will be characterized before and at the end of this period. This trial required the participants to stay at the investigational site for 14 consecutive days.

The enrollment visit took place Day -28 to Day -16. Participants tapered down their existing medication from Visit 2 (Day -17 to Day -5) to Visit 3 and were given rescue medication (paracetamol/acetaminophen). At Visit 3 participants were hospitalized (Day -4). The baseline evaluation period took place from Day -3 to Day -1. Randomization to one of the three treatment arms was possible after the last assessment on Day - 1 alternatively randomization took place on Day 1. This was followed by the double-blind treatment period (Day 1 to Day 7). The participants were follow-up thereafter up to day 36 (Day 34 to 38). Participants were permitted to resume their previous medication.

Arms: arm 1: Oral administration. Pain not sufficiently controlled may be treated with acetaminophen. arm 2: Oral administration. Pain not sufficiently controlled may be treated with acetaminophen. arm 3: Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.
Interventions: intervention 1: GRT6010 intervention 2: Pregabalin intervention 3: Matching Placebo
Intervention descriptions: intervention 1: Oral solution given once daily. intervention 2: Over-encapsulated pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7. intervention 3: Matching Placebo capsules to the over-encapsulated Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.

Capsules twice daily on Days 1 to 7. Solution once daily.

Protocol documents:
Clinical trial NCT01489969
Conditions: Primary Insomnia
Keywords: sleep latency Sleep maintenance Sleep fragmentation Polysomnography
Sponsor: Neurim Pharmaceuticals Ltd.
Start date: 2011-12-01; Completion date: 2013-01-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase II study. It is conducted using a randomized, double-blind, 3-arm placebo controlled, parallel group design. Eligible patients will be randomized in a 1:1:1 ratio to receive Neu-P11 20 mg, Neu-P11 50 mg or placebo for 4 weeks The objective of this study is to assess the efficacy of Neu-P11 (20 and 50mg) on sleep continuity parameters in insomnia patients aged 18-80 years, following the first two nights (immediate effect) and at the end of 4 weeks of double-blind treatment. The primary efficacy endpoint in this study is Latency to Persistent Sleep (LPS) measured by polysomnogram (PSG) at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings). The secondary endpoints are number of awakenings after sleep onset and the duration of wake after sleep onset measured by PSG at the first two nights of treatment (nights 15-16 of the study; mean of two consecutive nights recordings).

Detailed description:

Arms: arm 1: Neu-P11 dose of 20 mg arm 2: Neu-P11 dose of 50 mg arm 3: matching placebo
Interventions: intervention 1: Neu-P11
Intervention descriptions: intervention 1: 1 tablet daily 1-2 before bed time for 28 days of double blind treatment

Protocol documents:
Clinical trial NCT01517373
Conditions: Diabetes Mellitus, Type 2
Keywords: T2DM PF-04937319 Phase 2
Sponsor: Pfizer
Start date: 2012-02-01; Completion date: 2013-01-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin

Detailed description:

Arms: arm 1: Placebo to match PF-04937319 and glimepiride arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: Placebo intervention 2: PF-04937319 10 mg intervention 3: PF-04937319 50 mg intervention 4: PF-04937319 100 mg intervention 5: Glimepiride
Intervention descriptions: intervention 1: Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days intervention 2: Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days intervention 3: Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days intervention 4: Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days intervention 5: Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days

Protocol documents:
Clinical trial NCT01518257
Conditions: Osteoarthritis
Sponsor: Allergan
Start date: 2012-01-01; Completion date: 2013-01-01
Enrollment: 121 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.

Detailed description:

Arms: arm 1: A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. arm 2: A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
Interventions: intervention 1: botulinum toxin Type A intervention 2: Normal Saline
Intervention descriptions: intervention 1: A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. intervention 2: A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Protocol documents:
Clinical trial NCT01542255
Conditions: Metastatic Melanoma
Keywords: Metronomic Therapy Metastatic Melanoma Vinblastine Cyclophosphamide Dacarbazine
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2010-06-01; Completion date: 2013-01-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
SUMMARY: Metronomic Therapy in Patients with Metastatic Melanoma: A Phase II Study of Low Dose Vinblastine, Cyclophosphamide, and Dacarbazine.

Patients with measurable metastatic melanoma are eligible. All patients will be treated as outlined below with combined vinblastine, cyclophosphamide, and dacarbazine. Patients will be treated continuously, until evidence of progression of disease, or for up to two cycles following disappearance of all disease. A cycle will be defined as three weeks of continuous therapy with a one week rest.

Detailed description:
Low dose continuous chemotherapy, called metronomic chemotherapy, is designed to target vascular cells and inhibit tumor growth and metastasises. A recent study in a melanoma mouse model has identified low dose vinblastine, cyclophosphamide and dacarbazine as a treatment which improves the animal's survival and is superior to full dose dacarbazine alone. This clinical trial seeks to translate this laboratory model directly into metastatic melanoma patients.

Arms: arm 1: A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.

Schema of treatment is:

1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv
Interventions: intervention 1: vinblastine intervention 2: Cyclophosphamide intervention 3: dacarbazine
Intervention descriptions: intervention 1: 1 mg/m2 vinblastine given three times per week administered intravenously. intervention 2: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest intervention 3: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest

Protocol documents:
Clinical trial NCT01548287
Conditions: Mild Cognitive Impairment Mild Alzheimer's Disease
Keywords: Mild Cognitive Impairment Mild Alzheimer's disease Safety Tolerability
Sponsor: AstraZeneca
Start date: 2012-04-01; Completion date: 2013-01-01
Enrollment: 164 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study where AZD5213 or placebo is given to patients with Mild Alzheimer's Disease or Mild Cognitive Impairment in a blinded and random assignment. The main study objective is to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.

Detailed description:
A Phase IIa Safety and Tolerability Study to Investigate the Effect on Sleep of 3 Doses of AZD5213 and Placebo in Patients with Mild Alzheimer's Disease and Mild Cognitive Impairment During 4 Weeks of Treatment, Designed as a Randomized, Double-Blind, Multi-Center, Parallel Group, Placebo-Controlled Study

Arms: arm 1: AZD5213 doseA daily arm 2: AZD 5213 doseB daily arm 3: AZD5213 doseC daily arm 4: Placebo daily
Interventions: intervention 1: AZD5213 intervention 2: AZD5213 intervention 3: AZD5213 intervention 4: Placebo
Intervention descriptions: intervention 1: AZD5213 doseA daily intervention 2: AZD5213 doseB daily intervention 3: AZD5213 doseC daily intervention 4: Placebo tablet daily

Protocol documents:
Clinical trial NCT01553539
Conditions: Bone Cancer Chondrosarcoma Clear Cell Sarcoma of the Kidney Metastatic Osteosarcoma Ovarian Sarcoma Recurrent Adult Soft Tissue Sarcoma Recurrent Osteosarcoma Recurrent Uterine Sarcoma Stage III Adult Soft Tissue Sarcoma Stage III Uterine Sarcoma Stage IV Adult Soft Tissue Sarcoma Stage IV Uterine Sarcoma
Sponsor: Wake Forest University Health Sciences
Start date: 2009-10-01; Completion date: 2013-01-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well therapeutic angiotensin-(1-7) works as second-line therapy or third-line therapy in treating patients with metastatic sarcoma that cannot be removed by surgery. Therapeutic angiotensin-(1-7) may stop the growth of sarcoma by blocking blood flow to the tumor.

Funding Source - FDA Office of Orphan Drug Products (OOPD)

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response rate of chemotherapy-refractory sarcomas to 20 mg per day of single-agent Ang(Angiotensin)-(1-7) or 10 mg per day of single-agent Ang-(1-7) if excessive toxicity is observed at the 20 mg dose.

II. To evaluate toxicities associated with single-agent Ang-(1-7) when given to patients with chemotherapy-refractory sarcomas.

SECONDARY OBJECTIVES:

I. To assess time to progression (TTP) and overall survival (OS) in patients treated with Ang-(1-7).

II. To evaluate accumulation of Ang-(1-7) after 21 days of continuous treatment and quantify changes in plasma levels of angiogenic peptides including placental growth factor (PlGF).

OUTLINE:

Patients receive therapeutic angiotensin-(1-7) subcutaneously (SC) once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Arms: arm 1: Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: therapeutic angiotensin-(1-7) intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given SC intervention 2: Correlative study

Protocol documents:
Clinical trial NCT01563978
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Sponsor: AstraZeneca
Start date: 2012-04-01; Completion date: 2013-01-01
Enrollment: 266 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of fostamatinib compared to placebo on ambulatory blood pressure in patients with active rheumatoid arthritis who are taking a disease-modifying anti-rheumatic drug (DMARD).

The study will last for 57 days.

Detailed description:
OSKIRA-ABPM: A Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of the Effect of Fostamatinib 100 mg Twice Daily on 24-hour Ambulatory Blood Pressure in Patients with Rheumatoid Arthritis

Arms: arm 1: Oral treatment arm 2: Oral treatment
Interventions: intervention 1: fostamatinib intervention 2: placebo
Intervention descriptions: intervention 1: fostamatinib 100 mg twice daily intervention 2: placebo

Protocol documents:
Clinical trial NCT01576952
Conditions: Ocular Inflammation
Sponsor: Sun Pharmaceutical Industries Limited
Start date: 2012-07-01; Completion date: 2013-01-01
Enrollment: 268 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-303 compared with DuraSite Vehicle.

Detailed description:

Arms: arm 1: 0.075% bromfenac in DuraSite vehicle dosed BID arm 2: DuraSite Vehicle dosed BID
Interventions: intervention 1: ISV-303 intervention 2: DuraSite Vehicle
Intervention descriptions: intervention 1: Bromfenac in DuraSite intervention 2: DuraSite Vehicle

Protocol documents:
Clinical trial NCT01579565
Conditions: Intraocular Lens Replacement
Keywords: cataract lens replacement
Sponsor: Omeros Corporation
Start date: 2012-04-01; Completion date: 2013-01-01
Enrollment: 416 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety, efficacy and pharmacokinetics of OMS302 (the study drug) for maintaining intraoperative mydriasis and preventing post operative pain in individuals undergoing Intraocular Lens Replacement (ILR) surgery.

Detailed description:

Arms: arm 1: OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery. arm 2: Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.
Interventions: intervention 1: OMS302 intervention 2: Placebo
Intervention descriptions: intervention 1: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced saline salt (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS. intervention 2: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.

Protocol documents:
Clinical trial NCT01593592
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori Lactobacillus reuteri dyspeptic patients eradication
Sponsor: Zagazig University
Start date: 2012-06-01; Completion date: 2013-01-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

Detailed description:
Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.

Arms: arm 1: The active group that will receive the standard triple therapy and Lactobacillus reuteri arm 2: The control group that will receive the standard triple therapy and placebo
Interventions: intervention 1: Lactobacillus reuteri intervention 2: Placebo intervention 3: Omeprazole intervention 4: Amoxicillin intervention 5: Clarithromycin
Intervention descriptions: intervention 1: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks. intervention 2: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks. intervention 3: All patients will receive omeprazole 20 mg b.i.d for 2 week intervention 4: amoxicillin 1000 mg b.i.d for 2 weeks intervention 5: clarithromycin 500mg b.i.d for 2 weeks

Protocol documents:
Clinical trial NCT01594970
Conditions: Glaucoma, Open-Angle Ocular Hypertension
Sponsor: Allergan
Start date: 2012-03-01; Completion date: 2013-01-01
Enrollment: 800 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the safety and efficacy of bimatoprost 0.01% in subjects with elevated intraocular pressure (IOP) due to primary open-angle glaucoma (POAG) or ocular hypertension (OH).

Detailed description:

Arms: arm 1: 1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks. arm 2: 1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks. arm 3: 1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
Interventions: intervention 1: Bimatoprost 0.01%
Intervention descriptions: intervention 1: 1 drop in the affected eye(s), administered in the evening for 12 weeks.

Protocol documents:
Clinical trial NCT01601470
Conditions: Mild to Moderate Hypertension
Keywords: LCZ696, sildenafil, pharmacokinetics, mild to moderate hypertension
Sponsor: Novartis Pharmaceuticals
Start date: 2012-09-01; Completion date: 2013-01-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study was conducted to investigate the potential for a pharmacokinetic drug-drug interaction in support of the co-administration of LCZ696 and sildenafil.

Detailed description:
This study was conducted to investigate the potential for a pharmacokinetic drug-drug interaction in patients with mild-to-moderate hypertension in support of the co-administration of LCZ696 and sildenafil.

Arms: arm 1: During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696 , co-administered at the same time with a single dose of sildenafil.
Interventions: intervention 1: LCZ696 intervention 2: Sildenafil
Intervention descriptions: intervention 1: LCZ696 400mg QD was administered alone for 4 days and in combination with sildenafil for 1 day intervention 2: Sildenafil 50 mg single dose was administered alone for 1 days and in combination with LCZ696 400mg QD for 1 day

Protocol documents:
Clinical trial NCT01602198
Conditions: Mild Cognitive Disorder Mild Cognitive Impairment
Sponsor: The Cleveland Clinic
Start date: 2011-06-01; Completion date: 2013-01-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this project is to determine if task-activated fMRI is sensitive to the central cholinergic deficit associated with Mild Cognitive Impairment.

Detailed description:
Clinical studies suggest that cholinesterase inhibitors (ChEIs) exert a cognitive benefit with chronic use among MCI and AD patients. Some studies also demonstrate a slight treatment benefit for persons who are APOE 4 positive. We propose to conduct a 24-week, randomized, double-blind, placebo-controlled, parallel group study of the Exelon® \[rivastigmine\] transdermal patch in 120 aMCI patients who have one or both APOE 4 alleles. Our preliminary analyses indicate that aMCI patients, even those who convert to AD, exhibit increased fMRI activation on our semantic memory activation task relative to not at-risk healthy participants and that increasing activation over time correlates with declines on neuropsychological testing. In addition, our preliminary data indicate that ChEI treated aMCI patients demonstrate normalization (i.e. reduction) in the magnitude of task-related neural activation over time relative to an untreated group. Furthermore, changes in fMRI magnitude demonstrated greater sensitivity to cholinergic modulation than changes on neuropsychological testing.

Arms: arm 1: Exelon \[rivastigmine\] transdermal patch arm 2: Placebo transdermal patch
Interventions: intervention 1: Exelon [rivastigmine] transdermal patch intervention 2: Placebo transdermal patch
Intervention descriptions: intervention 1: Exelon patch 1/day for six months intervention 2: Placebo transdermal patch 1/day for 6 months

Protocol documents:
Clinical trial NCT01602341
Conditions: Dermatitis, Atopic
Keywords: atopic dermatitis
Sponsor: Pfizer
Start date: 2012-08-01; Completion date: 2013-01-01
Enrollment: 86 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of AN2728 Topical Ointment, 2% and 0.5%, administered once a day (QD) or twice a day (BID), in the treatment of adolescents with atopic dermatitis (AD)

Detailed description:

Arms: arm 1: AN2728 Topical Ointment, 2% applied once daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied once daily for 29 days to a target lesion

Treatments will be randomly assigned to target lesions A and B. arm 2: AN2728 Topical Ointment, 2% applied twice daily for 29 days to a target lesion, and AN2728 Topical Ointment, 0.5% applied twice daily for 29 days to a target lesion.

Treatments will be randomly assigned to target lesions A and B.
Interventions: intervention 1: AN2728 Topical Ointment, 2% QD intervention 2: AN2728 Topical Ointment, 0.5% QD intervention 3: AN2728 Topical Ointment, 2% BID intervention 4: AN2728 Topical Ointment, 0.5% BID
Intervention descriptions: intervention 1: AN2728 Topical Ointment, 2% QD intervention 2: AN2728 Topical Ointment, 0.5% QD intervention 3: AN2728 Topical Ointment, 2% BID intervention 4: AN2728 Topical Ointment, 0.5% BID

Protocol documents: