ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00633932
Conditions: Reflux Esophagitis
Keywords: Reflux Esophagitis
Sponsor: AstraZeneca
Start date: 2007-12-01; Completion date: 2008-12-01
Enrollment: 602 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 according to the Los Angeles classification .

Detailed description:

Arms: arm 1: Esomeprazole 20mg arm 2: Esomeprazole 40mg arm 3: Omeprazole 20mg
Interventions: intervention 1: Esomeprazole intervention 2: Esomeprazole intervention 3: Omeprazole
Intervention descriptions: intervention 1: 20mg once daily intervention 2: 40 mg once daily intervention 3: 20mg once daily

Protocol documents:
Clinical trial NCT00635232
Conditions: Hypertension
Keywords: Hypertension High Blood Pressure
Sponsor: Ligand Pharmaceuticals
Start date: 2008-03-01; Completion date: 2008-12-01
Enrollment: 261 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn which doses of PS433540 should be given to patients with high blood pressure to lower their blood pressure. This study will also examine how safe PS433540 is when taken by patients with high blood pressure. Approximately 720 patients will be evaluated so that about 375 patients will be entered into the treatment phase of the study and be given PS433540.

Detailed description:

Arms: arm 1: Irbesartan 300 mg once daily arm 2: Blinded Placebo Treatment arm 3: PS433540 200mg once daily arm 4: PS433540 400mg once daily arm 5: PS433540 800mg once daily
Interventions: intervention 1: irbesartan intervention 2: placebo intervention 3: PS433540 intervention 4: PS433540 intervention 5: PS433540
Intervention descriptions: intervention 1: 300 mg (2 x 150 mg capsules) once daily for 12 weeks intervention 2: placebo capsules once daily for 12 weeks intervention 3: 200 mg (2 x 100 mg capsules) once daily for 12 weeks intervention 4: 400 mg (4 x 100 mg capsules) once daily for 12 weeks intervention 5: 800 mg (8 x 100 mg capsules) once daily for 12 weeks

Protocol documents:
Clinical trial NCT00640042
Conditions: Pain
Keywords: pain opioid abuse moderate-severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time
Sponsor: Pfizer
Start date: 2008-03-01; Completion date: 2008-12-01
Enrollment: 1570 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide information in a broad, "real world" population of chronic pain patients assessing both pain control with AVINZA as well as the potential risk for misuse and abuse.

Detailed description:
Pain affects more Americans than diabetes, heart disease and cancer combined and although it is one of the earliest known ailments, pain is still without a universal cure. It is estimated that only about 25% of patients with chronic pain receive adequate analgesia.

Long-term treatment of chronic pain with opioids is recognized as an important treatment option for patients with moderate-severe pain related to cancer and other chronic serious illnesses. AVINZA (morphine sulfate extended-release capsules) was approved for marketing by the Food and Drug Administration (FDA) in 2002 as a once daily treatment for the relief of moderate to severe pain requiring continuous opioid therapy for an extended period of time. While opioids, such as AVINZA, are beneficial in the management of chronic pain, they are sometimes associated with illicit activities. Misuse, abuse and diversion of controlled prescription drugs, particularly opioids, are problems that have increased dramatically in the United States (U.S.) since the 1990s.

This study will follow the Federation of State Medical Boards Model Policy for the Use of Controlled Substances for the Treatment of Pain. Patients will be counseled on the proper storage and destruction of unused AVINZA in accordance with federal and applicable state laws. A universal precautions approach to chronic pain management (KAIR) will be utilized in this study. Although not validated as a risk assessment and management instrument, KAIR is designed to assist clinicians with responsibly managing chronic moderate-severe pain patients prescribed AVINZA. The KAIR tools will be used by the Investigator to determine the level of monitoring required based on the patient's potential risk for opioid misuse or abuse (KAIR level). Investigators and staff participating in this study will be required to participate in a training program on the counseling to be given, procedures to be followed and tools to be used in this study.

Arms: arm 1: None
Interventions: intervention 1: morphine sulfate extended release capsules
Intervention descriptions: intervention 1: 30 mg, 60 mg, 90 mg, 120 mg morphine will be prescribed by the Investigator in accordance with the AVINZA prescribing information.

Protocol documents:
Clinical trial NCT00648037
Conditions: Hodgkin's Disease Leukemia Myelodysplastic Syndrome Non-Hodgkin's Lymphoma
Keywords: RITUXIMAB Lymphoma
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-03-01; Completion date: 2008-12-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if we can prevent Epstein Barr Virus lymphomas by the monthly administration of an (antibody) protein against B lymphocytes called Rituximab. Although this medicine has been approved by the Food and Drug Administration to treat patients with other types of lymphomas, and has been used to treat a small number of patients with EBV lymphomas and other types of B-cell leukemias, it has not been approved to try and prevent EBV-lymphomas. Use of Rituximab to try to prevent EBV-lymphomas is therefore experimental.

Detailed description:

Arms: arm 1: Patients following a T cell depleted HLA-mis-matched related or unrelated hematopoietic stem cell transplant (HSCT) will be treated with monthly Rituximab.
Interventions: intervention 1: Rituximab
Intervention descriptions: intervention 1: Rituximab 375 mg/m\^2 starting approximately 1 month post transplant (no later than day 45), and continuing monthly until the CD4 cell count is \> 200 cells/ul or a maximum of 6 doses have been given.

Protocol documents:
Clinical trial NCT00660595
Conditions: Schizophrenic Disorders
Keywords: Schizophrenia Schizoaffective psychosis Schizophreniformic psychosis Pilot study Quetiapine Prolong Risperidone
Sponsor: AstraZeneca
Start date: 2008-09-01; Completion date: 2008-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot trial in Finland is designed to evaluate in a randomized fashion change of agitation in acute schizophrenic patients (Schizophrenia or Schizoaffective psychosis or Schizophreniformic psychosis)Diagnostic and Statistical Manual (DSM - IV) with the first visits on days 1, 2, 4 or 5 and 7 ± 1.

Detailed description:

Arms: arm 1: Oral arm 2: Oral
Interventions: intervention 1: Quetiapine intervention 2: Risperidone
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration

Protocol documents:
Clinical trial NCT00662857
Conditions: Diabetes Mellitus: Type 1
Keywords: Diabetic adult male, diabetic adult female
Sponsor: Mannkind Corporation
Start date: 2008-04-01; Completion date: 2008-12-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).

Detailed description:
28 eligible subjects were planned to be enrolled to determine bioequivalence and safety parameters of two 15 U TI Inhalation Powder cartridges versus one 30 U TI Inhalation Powder cartridge, according to a randomized, 2-way crossover design. Additionally, bioavailability of one 30 U TI Inhalation Powder cartridge to a single subcutaneous injection of 10 IU of RAA will be compared.

Arms: arm 1: Technosphere® Insulin Inhalation Powder, two 15 U cartridges arm 2: Technosphere® Insulin Inhalation Powder, one 30 U cartridge arm 3: Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro
Interventions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Technosphere Insulin® Inhalation Powder intervention 3: RAA Population
Intervention descriptions: intervention 1: TI Inhalation Powder, two 15 U cartridges intervention 2: TI Inhalation Powder, one 30 U cartridge intervention 3: RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.

Protocol documents:
Clinical trial NCT00671671
Conditions: Hepatitis, Chronic Hepatitis C Virus
Sponsor: Pfizer
Start date: 2008-04-01; Completion date: 2008-12-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1 study in HVC (Hepatitis C Virus) infected subjects to determine pharmacokinetics, safety and efficacy in subjects with no or inadequate response to prior treatment.

Detailed description:

Arms: arm 1: None arm 2: Dose study drug in subjects who have previously failed to respond to interferon based therapies
Interventions: intervention 1: Small Molecule Agent (PF-868554) intervention 2: Small Molecule Agent (PF-868554)
Intervention descriptions: intervention 1: Study drug will be administered 700mg BID in the fed state for three days. intervention 2: Study drug will be given 450mg BID for a duration of 10 days.

Protocol documents:
Clinical trial NCT00673933
Conditions: Acne Vulgaris
Sponsor: Photocure
Start date: 2008-05-01; Completion date: 2008-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this multicenter study, patients with dark skin and acne vulgaris will be included. The patients will receive treatment with MAL PDT and placebo PDT.

Detailed description:
The treatment period started within 2 weeks of the study screen. Patients received two treatments (MAL PDT and vehicle PDT) to each of the treatment areas, 2 weeks apart, and were followed-up 4 weeks after last treatment. The total duration of the study was 6-8 weeks.

Methyl aminolevulinate 80 mg/g cream (MAL cream 8%)and vehicle was applied for 1.5 hours before illumination (Aktilite® CL128), total light dose 37 J/cm2

Arms: arm 1: PDT using MAL crem arm 2: PDT using Placebo cream
Interventions: intervention 1: Methyl aminolevulinate (MAL) PDT
Intervention descriptions: intervention 1: Cream application followed by illumination with red light

Protocol documents:
Clinical trial NCT00675987
Conditions: Obesity Hypertension Hyperglycemia
Keywords: Impaired Fasting Glucose FPG >100-<126 mg/dL
Sponsor: Brigham and Women's Hospital
Start date: 2007-05-01; Completion date: 2008-12-01
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purposes of this study are to find out if the study drug losartan (Cozaar) or placebo ("sugar pill") has an effect on insulin sensitivity (how your body responds to insulin) and to measure the effect of the study drug losartan or placebo on how the arteries in your arm dilate (enlarge to carry more blood).

We hope to learn if taking losartan changes the amount of certain proteins in the blood that effect blood vessel function.

Losartan is approved by the US FDA to treat high blood pressure. It will take approximately 4 months for you to complete this study.

Detailed description:

Arms: arm 1: Losartan 100 mg 1 tab po QD arm 2: Placebo 1 tab po QD
Interventions: intervention 1: losartan intervention 2: Placebo control
Intervention descriptions: intervention 1: losartan 100 mg tablets 1 tab po QD intervention 2: Placebo 1 po QD

Protocol documents:
Clinical trial NCT00676780
Conditions: Prostate Cancer
Keywords: EGCG polyphenols biomarkers prostate specific antigen
Sponsor: Louisiana State University Health Sciences Center Shreveport
Start date: 2004-05-01; Completion date: 2008-12-01
Enrollment: 33 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.

Detailed description:
To evaluate the short-term effects of a daily dose of Polyphenon E administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.

The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary objective. Secondary objectives include the effects on the other tissue and serum biomarkers. Evaluation of the safety and tolerability of Polyphenon E in this subject population is another objective.

1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation levels in patients with prostate cancer 1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with prostate cancer 1.3 Determine the effects of Polyphenon E on MAPK activation in patients with prostate cancer 1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in motility and invasion such as Rho GTPases and extracellular proteinases in patients with prostate cancer 1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with prostate cancer 1.6 Determine the effects of Polyphenon E on serum Prostate Specific Antigen (PSA) in patients with prostate cancer 1.7 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP), Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3), Hepatocyte Growth Factor HGF 1.8 Evaluate the safety and tolerability of Polyphenon E in this subject population

Arms: arm 1: Single arm for a phase II study
Interventions: intervention 1: Polyphenon E (EGCG)
Intervention descriptions: intervention 1: 4 capsules daily with a meal for the duration of the study

Protocol documents:
Clinical trial NCT00678574
Conditions: Premenstrual Dysphoric Disorder Premenstrual Syndrome
Keywords: hormones menses PMS PMDD
Sponsor: University of Pennsylvania
Start date: 1998-03-01; Completion date: 2008-12-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study proposed is to investigate the role of neurosteroids and GABA in the pathophysiology and treatment of premenstrual dysphoric disorder (PMDD) by 1) measuring cortical gama-aminobutyric acid levels (GABA levels) using nuclear magnetic resonance spectroscopy (MRS) during the follicular and mid-luteal phases of the menstrual cycle pre and post treatment with the selective serotonin reuptake inhibitor (SSRI) fluoxetine (Prozac®, Sarafem®), and 2) correlating cerebrospinal fluid (CSF) and plasma GABA and neurosteroid levels with cortical GABA levels at these same time points. Neurosteroids to be measured include allopregnanolone, pregnenolone, and pregnenolone sulfate. Findings from women with PMDD will be compared to those of healthy subjects.

Detailed description:

Arms: arm 1: PMDD group received fluoxetine 20 mg daily by mouth for 2-3 months arm 2: None
Interventions: intervention 1: fluoxetine
Intervention descriptions: intervention 1: Fluoxetine 20 mg daily by mouth for 2-3 months.

Protocol documents:
Clinical trial NCT00683774
Conditions: PCOS
Sponsor: Virginia Commonwealth University
Start date: 2005-11-01; Completion date: 2008-12-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Increased insulin levels leads to increased secretion of D-chiro inositol(DCI) from the kidneys in women with PCOS, but not in normal women. This leads to a reduction in circulating DCI and insulin stimulated release of DCI-IPG.To determine if decreasing circulating insulin directly by inhibition of islet insulin release with diazoxide in obese women with PCOS 1)decreases the renal clearance of DCI and 2) increases the circulating concentration of DCI.

Detailed description:

Arms: arm 1: PCOS subjects given diazoxide arm 2: Normal subjects given diazoxide
Interventions: intervention 1: diazoxide
Intervention descriptions: intervention 1: 100mg orally three times per day for 10 days

Protocol documents:
Clinical trial NCT00686231
Conditions: Healthy
Keywords: To determine if topical nitroglycerin acts to vasodilate the radial artery by a direct local action, or by systemic vasodilation To determine if topical nitroglycerin dilates the radial artery in the presence of local anesthetic agents used in cardiac catheterization
Sponsor: University of California, San Francisco
Start date: 2008-05-01; Completion date: 2008-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The radial artery, which is located on the outer side of the forearm, can be used in interventional procedures, such as cardiac catheterization, to provide access to the arterial blood supply. In order to facilitate successful catheterization of the artery, a dilated artery and one free of arterial spasm is desirable. The proposed study will randomize twenty three healthy subjects in 2 visits to determine the effect of topical nitroglycerin on radial artery vasodilation. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours.

Detailed description:
During the first study visit, as a dose-optimizing study, each subject will be randomly assigned to one of two Dose-Test arms to receive either 15mg or 30mg of nitroglycerin on one wrist and placebo on the other. Radial artery diameter will be measured with ultrasound at regular intervals up to two hours. On the second study visit, the same participants will be randomly assigned to one of two Combination-Test arms to receive bilateral topical application of either 20mg or 40mg of lidocaine; the lidocaine will be applied in combination with 30mg of nitroglycerin on one wrist and in combination with placebo on the other wrist. Measurements of radial artery diameter will be performed as in the first visit.

Arms: arm 1: Nitroglycerin 15mg (NTG) applied topically to one wrist and placebo to the other wrist at Visit 1 arm 2: Nitroglycerin 30mg applied topically to one wrist and placebo to the other wrist at Visit 1 arm 3: Lidocaine 20mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 20mg + placebo applied to the other wrist, at Visit 2 arm 4: Lidocaine 40mg + Nitroglycerin 30mg applied topically to one wrist, Lidocaine 40mg + placebo applied to the other wrist, at Visit 2
Interventions: intervention 1: Nitroglycerin 15mg intervention 2: Nitroglycerin 30mg intervention 3: Lidocaine 20mg intervention 4: Lidocaine 40mg intervention 5: Placebo
Intervention descriptions: intervention 1: 15mg Nitroglycerin applied topically to one wrist intervention 2: 30mg Nitroglycerin applied topically to one wrist intervention 3: 20mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo intervention 4: 40mg Lidocaine applied topically to one wrist in combination with nitroglycerin or placebo intervention 5: Topical skin moisturizing cream with same appearance as active agent

Protocol documents:
Clinical trial NCT00688519
Conditions: Psoriasis
Keywords: Plaque-type Psoriasis Psoriasis
Sponsor: Stiefel, a GSK Company
Start date: 2008-03-01; Completion date: 2008-12-01
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate the safety and efficacy of U0267 in subjects with plaque-type psoriasis.

Detailed description:

Arms: arm 1: U0267 is a vitamin D3 analog (calcipotriene) foam. It is applied twice a day for 8 weeks to psoriasis lesions on the body. arm 2: Vehicle foam is the same as the U0267 foam except that it does not have the active ingredient. It is applied twice a day for 8 weeks to psoriasis lesions on the body.
Interventions: intervention 1: U0267 intervention 2: Vehicle
Intervention descriptions: intervention 1: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp). intervention 2: All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face and scalp).

Protocol documents:
Clinical trial NCT00690482
Conditions: Moderate to Severe COPD
Keywords: COPD
Sponsor: AstraZeneca
Start date: 2008-05-01; Completion date: 2008-12-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study efficacy and safety of AZD1981 in patients with Chronic Obstructive Pulmonary Disease

Detailed description:

Arms: arm 1: AZD1981 Oral tablet, twice daily arm 2: Placebo Oral tablet, twice daily
Interventions: intervention 1: AZD1981 intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablet, twice daily intervention 2: Placebo Oral tablet, twice daily

Protocol documents:
Clinical trial NCT00690820
Conditions: Cystic Fibrosis Pancreatic Exocrine Insufficiency
Keywords: Cystic Fibrosis Pancreatic Exocrine Insufficiency
Sponsor: Solvay Pharmaceuticals
Start date: 2008-06-01; Completion date: 2008-12-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pancrelipase Delayed Release intervention 2: Placebo Comparator
Intervention descriptions: intervention 1: 12,000 unit Capsules, dosed individually based on fat intake. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00702143
Conditions: Alzheimer's Disease Mild Cognitive Impairment
Sponsor: Avid Radiopharmaceuticals
Start date: 2008-06-01; Completion date: 2008-12-01
Enrollment: 184 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Detailed description:

Arms: arm 1: None arm 2: MCI (mild cognitive impairment) arm 3: None
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 370MBq (10mCi), single dose

Protocol documents: