ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01056198
Conditions: Diabetic Foot Ulcers Foot Wounds
Keywords: Diabetic Foot Ulcers Diabetic Foot Wounds
Sponsor: Healthpoint
Start date: 2010-02-01; Completion date: 2011-11-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study tests two different approaches to the removal of dead tissue from the surface of a wound.

Detailed description:

Arms: arm 1: 2 mm Santyl applied once daily arm 2: Daily gauze and optional sharp debridement
Interventions: intervention 1: Santyl intervention 2: Control
Intervention descriptions: intervention 1: 2 mm Santyl applied once daily. intervention 2: Daily gauze and optional sharp debridement

Protocol documents:
Clinical trial NCT01069939
Conditions: Prevention
Keywords: Gastric ulcer Duodenal ulcer Low-dose aspirin
Sponsor: AstraZeneca
Start date: 2010-02-01; Completion date: 2011-11-01
Enrollment: 427 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.

Detailed description:

Arms: arm 1: Esomeprazole 20mg once daily oral arm 2: Placebo once daily oral
Interventions: intervention 1: Esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: 20mg, capsule, 72 weeks intervention 2: Placebo, capsule, 72 weeks

Protocol documents:
Clinical trial NCT01071915
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2010-03-01; Completion date: 2011-11-01
Enrollment: 157 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-centre single arm trial to investigate efficacy and safety of degarelix in Korean patients with prostate cancer for bridging between CS21 trial (NCT00295750) results.

Detailed description:

Arms: arm 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
Interventions: intervention 1: Degarelix 240/80 mg
Intervention descriptions: intervention 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.

Protocol documents:
Clinical trial NCT01072396
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2010-02-01; Completion date: 2011-11-01
Enrollment: 126 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Optimal clinical management in early stages of COPD is not established. Tiotropium has been shown to improve exercise tolerance during (CWR) cycle ergometry with GOLD stage II to IV COPD, improvements in constant speed treadmill time in a study of patients who also received pulmonary rehabilitation in a population of patients with predominantly severe and very severe disease (GOLD stages III and IV) and improvements in exertional dyspnea, and Shuttle Walk Test distance in GOLD stage III and IV COPD. However, data are lacking on the benefits of tiotropium on exercise tolerance in a patients with early stages of COPD who are symptomatic. Patients with milder ventilatory limitations (GOLD stages I/II COPD patients) may benefit from maintenance therapy and there is limited data on exercise limitation in patients with early stage COPD who are symptomatic. This study is designed to evaluate the mechanisms of breathlessness and assess physical activity limitation in early stage COPD patients compared to age and gender matched controls and will secondly investigate the effectiveness of treatment with tiotropium in improving dyspnea during exercise and exercise duration as a result of the bronchodilation effects of tiotropium leading to a reduction of dynamic hyperinflation in Early Stage COPD patients.

Detailed description:

Arms: arm 1: Patient to receive 1 tiotropium bromide inhalation powder capsule daily (in the morning) via HandiHaler arm 2: Patient to receive 1 placebo inhalation powder capsule daily (in the morning) identical to those containing tiotropium bromide inhalation powder via HandiHaler arm 3: Age and gender matched control subjects to conduct incremental and constant work rate exercise tests for comparison to subjects with early stage COPD
Interventions: intervention 1: Tiotropium intervention 2: Placebo
Intervention descriptions: intervention 1: double blind randomized crossover intervention 2: inhalation powder capsule identical to those containing tiotropium bromide inhalation powder

Protocol documents:
Clinical trial NCT01077284
Conditions: Hyperuricosuria Kidney Stones
Keywords: Kidney Calculi Kidney Stones Nephrolithiasis Drug Therapy Uric Acid
Sponsor: Takeda
Start date: 2010-02-01; Completion date: 2011-11-01
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), compared to allopurinol or placebo in patients with excessive amounts of uric acid in their urine and who have recently had kidney stones.

Detailed description:
Nephrolithiasis, also called kidney stone disease, occurs in patients with genetic susceptibility and who may have a broad spectrum of metabolic disorders and other comorbid conditions (for example obesity or diabetes). These renal stones develop as a result of supersaturation. Calcium oxalate (CaOx) is the most common type of stone. Reducing the urinary excretion of uric acid is an established approach for the treatment of CaOx kidney stones.

The objective of this study is to evaluate treatment with febuxostat compared to allopurinol or placebo in the reduction of 24-hour urine uric acid (uUA) excretion levels in hyperuricosuric patients with a recent history of renal stones and the presence of at least one CaOx stone larger than or equal to 3 mm as seen on Multidetector Computed Tomographic Angiography (MDCT).

Participants in this study will be required to make 4 office visits provide 3 urine samples and undergo 2 MDCT scans (a type of x-ray) of their kidneys.

Arms: arm 1: Febuxostat 80 mg, capsules, orally, once daily for up to 6 months. arm 2: Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months. arm 3: Placebo-matching capsules, orally, once daily for up to 6 months.
Interventions: intervention 1: Febuxostat intervention 2: Allopurinol intervention 3: Placebo
Intervention descriptions: intervention 1: Febuxostat capsules intervention 2: Allopurinol capsules intervention 3: Placebo-matching capsules

Protocol documents:
Clinical trial NCT01079663
Conditions: Peri-implantitis
Sponsor: Dexcel Pharma Technologies Ltd.
Start date: 2010-03-01; Completion date: 2011-11-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the efficacy and the safety of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis.

Detailed description:
This is a Phase 2a study assessing the safety and efficacy of Chlorhexidine Gluconate chip (Periochip®) versus Placebo Chip in treatment of symptoms in patients with Peri-Implantitis

Arms: arm 1: PerioChip®, consisting of 2.5 mg Chlorhexidine Gluconate PerioChips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm arm 2: Placebo Chip Placebo Chips were inserted only to target pockets whose pocket depth (PD) at Baseline visit (Week 0), Week 2, Week 4, Week 6, Week 8, Week 12 and Week 18 was ≥ 6 mm
Interventions: intervention 1: Chlorhexidine 2.5 mg intervention 2: Placebo chip
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01085760
Conditions: Primary Sclerosing Cholangitis
Sponsor: Mayo Clinic
Start date: 2010-02-01; Completion date: 2011-11-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Vancomycin or Metronidazole is safe and beneficial in the treatment of Primary Sclerosing Cholangitis.

Detailed description:
In this protocol, we propose the assessment of potential beneficial effects of the antibiotics vancomycin and metronidazole on liver biochemistries, liver related symptoms and Mayo risk score in patients with PSC. The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. Each group will be treated for three months.

Arms: arm 1: The patients will be randomized into four groups of ten patients: one group will receive low dose vancomycin, one group will receive high dose vancomycin, one group will receive low dose metronidazole and one group will receive high dose metronidazole. arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Vancomycin intervention 2: Vancomycin intervention 3: Metronidazole intervention 4: Metronidazole intervention 5: Vancomycin
Intervention descriptions: intervention 1: Comparison of different doses of drug intervention 2: Comparison of different doses of drug intervention 3: Comparison of different doses of drug intervention 4: Comparison of different doses of drug intervention 5: Comparison of different drug doses

Protocol documents:
Clinical trial NCT01089556
Conditions: Diabetic Neuropathy, Painful
Sponsor: Eli Lilly and Company
Start date: 2010-03-01; Completion date: 2011-11-01
Enrollment: 811 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the efficacy of a combination treatment of duloxetine + pregabalin compared with the maximal dose of each drug in monotherapy, in patients with diabetic peripheral neuropathic pain (DPNP) who have not responded to the standard recommended dose of either drug. It will provide an answer to a common clinical question, namely, is it better to increase the dose of the current monotherapy or to combine both treatments early on, in patients who do not respond to standard doses of duloxetine or pregabalin.

Detailed description:

Arms: arm 1: Initial Treatment:

Duloxetine 30 milligram (mg) daily for 1 week

Duloxetine 60 mg daily for 7 weeks

Intensive Treatment:

Duloxetine 90 mg (60 mg in the morning, 30 mg in the evening) daily for 1 week

Duloxetine 120 mg (60 mg twice daily) daily for 7 weeks arm 2: Initial Treatment:

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Intensive Treatment:

Pregabalin 300 mg (150 mg twice daily) daily for 8 weeks

Duloxetine 30 mg daily for 1 week

Duloxetine 60 mg daily for 7 weeks arm 3: Initial Treatment:

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks

Intensive Treatment:

Pregabalin 450 mg (300 mg in the morning, 150 mg in the evening) daily for 1 week

Pregabalin 600 mg (300 mg twice daily) daily for 7 weeks arm 4: Initial Treatment:

Duloxetine 30 mg daily for 1 week

Duloxetine 60 mg daily for 7 weeks

Intensive Treatment:

Duloxetine 60 mg daily for 8 weeks

Pregabalin 150 mg daily for 1 week

Pregabalin 300 mg (150 mg twice daily) daily for 7 weeks
Interventions: intervention 1: Duloxetine intervention 2: Pregabalin intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered orally intervention 3: Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks

Protocol documents:
Clinical trial NCT01095094
Conditions: Brain Tumor Anaplastic Astrocytoma Anaplastic Ependymoma Anaplastic Oligodendroglioma Brain Stem Glioma Giant Cell Glioblastoma Glioblastoma Gliosarcoma Mixed Glioma
Keywords: adult brain tumor adult anaplastic astrocytoma adult anaplastic ependymoma adult anaplastic oligodendroglioma adult brain stem glioma adult giant cell glioblastoma adult glioblastoma adult gliosarcoma adult mixed glioma recurrent adult brain tumor
Sponsor: Case Comprehensive Cancer Center
Start date: 2009-01-01; Completion date: 2011-11-01
Enrollment: 19 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Ritonavir and lopinavir may stop the growth of gliomas by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well giving ritonavir together with lopinavir works in treating patients with progressive or recurrent high-grade glioma.

Detailed description:
PRIMARY OBJECTIVES: I. To evaluate the 6-month progression-free survival in patients with recurrent or progressive high grade gliomas treated with ritonavir and lopinavir. SECONDARY OBJECTIVES: I. To evaluate the toxicity of ritonavir and lopinavir in this patient population. OUTLINE: Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically.

Arms: arm 1: Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: ritonavir intervention 2: lopinavir
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol documents:
Clinical trial NCT01098578
Conditions: Epistaxis
Keywords: Posterior Epistaxis
Sponsor: Ottawa Hospital Research Institute
Start date: 2010-04-01; Completion date: 2011-11-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Effectiveness of Floseal for the treatment of posterior epistaxis.

Detailed description:
Floseal, a hemostatic agent, is an effective treatment for anterior epistaxis as well as numerous other acute bleeding conditions throughout the body. The investigators hypothesize that Floseal is an effective treatment for posterior epistaxis. If so, then this will also lead to significant cost savings in comparison to any other method of treatment of posterior epistaxis. The investigators have planned a prospective, nonblinded, nonrandomised study with a total of 40 subjects with posterior epistaxis to be included in this study.

Arms: arm 1: Received 1 syringe of Floseal for treatment of posterior epistaxis.
Interventions: intervention 1: Floseal
Intervention descriptions: intervention 1: Received 1 syringe of Floseal as treatment for posterior epistaxis.

Protocol documents:
Clinical trial NCT01101841
Conditions: Hot Flashes
Keywords: Vasomotor Symptoms Menopause Hot Flashes Perimenopause Nonhormonal therapies Climacteric symptoms Mesafem Low-Dose Mesylate salt of Paroxetine (LDMP)
Sponsor: Noven Therapeutics
Start date: 2010-03-01; Completion date: 2011-11-01
Enrollment: 570 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the safety and efficacy of Brisdelle (paroxetine mesylate) Capsules 7.5 mg for treatment of vasomotor symptoms (VMS) associated with menopause

Detailed description:
The study is a 24-week, multicenter, double-blind, randomized, placebo-controlled study of Brisdelle (paroxetine mesylate) Capsules 7.5 mg in subjects with moderate to severe postmenopausal VMS, defined as follows:

1. Moderate VMS: Sensation of heat with sweating, able to continue activity
2. Severe VMS: Sensation of heat with sweating, causing cessation of activity

The study is comprised of a screening period, a run-in period, a baseline visit, and a double-blind treatment period.

Arms: arm 1: Brisdelle (paroxetine mesylate) arm 2: Sugar pill
Interventions: intervention 1: Brisdelle (paroxetine mesylate) intervention 2: Placebo capsules
Intervention descriptions: intervention 1: Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio. intervention 2: Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.

Protocol documents:
Clinical trial NCT01110252
Conditions: Chronic Obstructive Pulmonary Disease Pulmonary Emphysema
Keywords: Chronic Obstructive Pulmonary Disease Emphysema Cell therapy Bone marrow mononuclear cells stem cells
Sponsor: UPECLIN HC FM Botucatu Unesp
Start date: 2009-05-01; Completion date: 2011-11-01
Enrollment: 4 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether the cell therapy with bone marrow mononuclear cells is safe in the treatment of chronic obstructive pulmonary disease, specifically the pulmonary emphysema.

Detailed description:
The main feature of the pulmonary emphysema, included in range of the Chronic Obstructive Pulmonary Disease (COPD), is the airflow obstruction resulting from the destruction of the alveolar walls distal to the terminal bronchiole, without significant pulmonary fibrosis. The existing clinical approaches has contributed to the enlargement and amelioration of the emphysema patients life quality, although no effective or curative treatment has been achieved. The surgical treatment, on the other hand, involves complex procedures and, in the specific case of lung transplantation, a lack of donors.

Considering these aspects, several experimental models have been proposed aiming to increase knowledge about the pathophysiological processes and enable new clinical approaches to the pulmonary emphysema. The cell therapy, briefly described as the use of cells in disease treatment, presents itself as a promising therapeutic approach with great potential applicability in degenerative pulmonary diseases. In this way, it is intended in this project, the proposition of a protocol to evaluate the safety of cell therapy with pool of mononuclear cells from bone marrow in patients with clinical and laboratory diagnosis of pulmonary emphysema in advanced stage (stage IV dyspnea).

Arms: arm 1: emphysema patients evaluated prior to the stem cells infusion arm 2: emphysema patients evaluated 30 days after the stem cells infusion
Interventions: intervention 1: Stem cells stimulation intervention 2: stem cells collection intervention 3: stem cells infusion
Intervention descriptions: intervention 1: Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure. intervention 2: pullout of 200ml of bone marrow through the puncture of the iliac crest intervention 3: slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.

Protocol documents:
Clinical trial NCT01115738
Conditions: Acute Coronary Syndrome
Keywords: Plavix, Effient
Sponsor: Eli Lilly and Company
Start date: 2010-05-01; Completion date: 2011-11-01
Enrollment: 282 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on platelet inhibition in patients presenting with acute coronary syndrome (ACS). Platelet inhibition following a prasugrel LD in clopidogrel pretreated patients' will be determined in a time-dependent manner for two different prasugrel loading doses (30 mg and 60 mg). Understanding the effects of this combination on platelet inhibition will provide guidance to physicians on the use of prasugrel in patients who have already been pretreated with clopidogrel.

Detailed description:

Arms: arm 1: Placebo loading dose administered once orally before percutaneous coronary intervention (PCI) and 60-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. arm 2: 600-mg clopidogrel loading dose administered once orally before PCI and 60-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. arm 3: 600-mg clopidogrel loading dose administered once orally before PCI and 30-mg prasugrel loading dose administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.
Interventions: intervention 1: Prasugrel intervention 2: Clopidogrel intervention 3: Placebo
Intervention descriptions: intervention 1: Loading dose administered once orally and maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours. intervention 2: Loading dose administered once orally. intervention 3: Loading dose administered once orally

Protocol documents:
Clinical trial NCT01119118
Conditions: Prostate Cancer
Keywords: Metastatic castrate-resistant prostate cancer bone metastasis
Sponsor: University of Wisconsin, Madison
Start date: 2010-04-01; Completion date: 2011-11-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to assess the effects of ZD4054 on prostate cancer that has spread to the bones by using new imaging techniques. In particular, this study will use fluorodeoxyglucose (FDG) and 18F-Sodium Fluoride (NaF) PET/computed tomography (CT) and MRI scans to look for changes in bone metastasis after ZD4054 therapy.

Detailed description:

Arms: arm 1: ZD4054 + multimodal PET/MRI imaging
Interventions: intervention 1: ZD4054
Intervention descriptions: intervention 1: All patients will be treated with ZD4054 at 10 mg PO daily, repeated in four week cycles (1 cycle = 28 days). All patients will initially undergo NaF and FDG PET/CT and MRI imaging at baseline (scan#1), and then again after 4 weeks (scan#2) of ZD4054 exposure. Subsequently, ZD4054 will be held for 2 weeks followed by the final NaF and FDG-PET/CT and MRI acquisition (scan#3). After the final PET/MRI is obtained, patients will resume ZD4054 and be assessed for safety prior to each new cycle of therapy. Standard disease evaluation assessments will be conducted after cycle#3, and repeated after every third cycle (sooner if clinically indicated). Therapy will continue until radiographical/clinical disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT01119937
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD NVA237
Sponsor: Novartis Pharmaceuticals
Start date: 2010-05-01; Completion date: 2011-11-01
Enrollment: 211 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 52-week, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily NVA237, using tiotropium as an active control, in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD) .

Detailed description:

Arms: arm 1: 50µg once daily arm 2: 18µg once daily
Interventions: intervention 1: NVA237 intervention 2: Tiotropium
Intervention descriptions: intervention 1: 50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®) intervention 2: 18µg capsules for inhalation, delivered via HandiHaler®

Protocol documents: