ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01060020
Conditions: Aortic Stenosis
Keywords: Aortic valve stenosis Sildenafil Phosphodiesterase inhibitors Hypertension, Pulmonary
Sponsor: Washington University School of Medicine
Start date: 2010-01-01; Completion date: 2011-10-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pulmonary hypertension is common in patients with aortic stenosis and is associated with worse operative and long-term outcomes. Sildenafil has been shown to reduce pulmonary artery pressure and improve exercise performance in patients with left-sided heart failure, but this has not been tested in patients with aortic stenosis. We hypothesize that Sildenafil will produce a clinically significant decrease in pulmonary artery pressure in patients with severe aortic stenosis. The dose of Sildenafil that produces a significant decrease in pulmonary artery pressure will be safe and well tolerated in patients with and without a depressed ejection fraction.

Detailed description:
Patients with severe aortic stenosis referred for a clinically ordered right and left heart catheterization will be eligible. Twenty subjects will be enrolled: 10 patients will receive 40mg and 10 patients will receive 80mg; each dose will be equally distributed among those with preserved (≥50%) and reduced (\<50%) EF. Subjects will get a baseline echo prior to the heart catheterization. Baseline invasive hemodynamic measurements will be performed using a Swan Ganz catheter. A single oral dose of sildenafil will then be administered (40mg or 80mg), followed by invasive hemodynamic measurements at 30 and 60 minutes. Also at 60 minutes, limited echocardiographic images will be obtained.

Arms: arm 1: A single oral dose of Sildenafil (either 40mg or 80mg) will be administered to a participant after baseline hemodynamics are measured in the catheterization lab. Each dose will be equally distributed among those with preserved (≥50%) and reduced (\<50%) EF.
Interventions: intervention 1: Sildenafil
Intervention descriptions: intervention 1: Single oral dose of 40mg or 80mg of Sildenafil

Protocol documents:
Clinical trial NCT01070784
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Symbicort Safety Efficacy COPD Japanese
Sponsor: AstraZeneca
Start date: 2010-01-01; Completion date: 2011-10-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Symbicort Turbuhaler compared to standard COPD treatment during one year in Japanese patients with COPD.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Symbicort Turbuhaler (Budesonide/formoterol) intervention 2: Drug: any available COPD treatment; investigator to decide
Intervention descriptions: intervention 1: 2 x 160/4.5 microgram, inhalation, bid, 52 weeks intervention 2: According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision

Protocol documents:
Clinical trial NCT01080248
Conditions: Pancreatic Cancer
Keywords: Pancreas
Sponsor: Washington University School of Medicine
Start date: 2010-08-01; Completion date: 2011-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the response rate and survival of gemcitabine and pazopanib in patients with metastatic pancreatic cancer.

Detailed description:
To determine the response rate by RECIST criteria.

To determine the progression free survival.

To determine the median survival and overall survival at one year.

Arms: arm 1: Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.

Pazopanib 800 mg PO daily of each 28 day cycle.
Interventions: intervention 1: Gemcitabine intervention 2: Pazopanib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01080625
Conditions: Hypotension After Reperfusion in Liver Transplantation
Keywords: postreperfusion syndrome phenylephrine epinephrine liver transplantation
Sponsor: Seoul National University Hospital
Start date: 2010-04-01; Completion date: 2011-10-01
Enrollment: 96 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Postreperfusion syndrome (PRS) is a relatively common phenomenon in patients undergoing liver transplantation which is characterized by an acute drop in blood pressure immediately after the prefusion is restored to the transplanted liver. We hypothesized that PRS would be prevented when phenylephrine or epinephrine is administered immediately prior to reperfusion in liver transplantation.

Detailed description:

Arms: arm 1: 100 mcg of phenylephrine is administered at the time of reperfusion arm 2: 10 mcg of epinephrine is administered iv at the time of reperfusion arm 3: 10 ml of normal saline is administered at the time of reperfusion
Interventions: intervention 1: phenylephrine intervention 2: epinephrine intervention 3: placebo control
Intervention descriptions: intervention 1: 100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion intervention 2: 10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion intervention 3: 10ml of normal saline is administered at the time of reperfusion

Protocol documents:
Clinical trial NCT01081912
Conditions: Back Pain Lower Back Chronic
Keywords: chronic pain back pain
Sponsor: Zogenix, Inc.
Start date: 2010-03-01; Completion date: 2011-10-01
Enrollment: 510 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain.

Detailed description:
A randomized Phase 3, placebo-controlled multi-center study to evaluate the safety, efficacy and tolerability of Hydrocodone Bitartrate controlled-release capsules in subjects with chronic low back pain. Subjects will go through an open-label conversion and titration phase followed by a randomized double-blind treatment phase of Hydrocodone (HC)-Controlled-Release (CR) vs. Placebo. The trial will consist of a Screening Phase (up to 14 days), an open-label Conversion and Titration Phase (up to 6 weeks), a 12-week placebo-controlled Treatment Phase, and a 2-week Follow-Up Phone Call

Arms: arm 1: Hydrocodone Bitartrate Controlled-Release Capsules arm 2: None
Interventions: intervention 1: Placebo intervention 2: Hydrocodone bitartrate
Intervention descriptions: intervention 1: Capsules, no active substance, shells identical to active comparator capsules intervention 2: dosage form: capsule

Strengths 10mg, 20mg, 30mg, 40mg, 50mg

Protocol documents:
Clinical trial NCT01085734
Conditions: Retinal Vein Occlusions
Sponsor: Maturi, Raj K., M.D., P.C.
Start date: 2010-03-01; Completion date: 2011-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparative study to see if treating with Osurdex in addition to Avastin in patients with retinal vein occlusions helps increased visual acuity outcomes

Detailed description:

Arms: arm 1: Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema arm 2: Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
Interventions: intervention 1: Avastin intervention 2: Osurdex intervention 3: Avastin
Intervention descriptions: intervention 1: 1.25mg intravitreally intervention 2: 0.7mg intravitreally intervention 3: 1.25mg intravitreally

Protocol documents:
Clinical trial NCT01094106
Conditions: Pain, Postoperative Caesarean Section
Keywords: postoperative pain infiltration analgesia ropivacaine Caesarean Section
Sponsor: North Karelia Central Hospital
Start date: 2010-04-01; Completion date: 2011-10-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.

According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.

The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.

Detailed description:

Arms: arm 1: Postoperative wound infusion 15 mg /h / 48h arm 2: Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
Interventions: intervention 1: Ropivacaine 0,75% intervention 2: NaCl 0,9%
Intervention descriptions: intervention 1: Postoperative wound infusion 2 ml/ h/ 48h intervention 2: Postoperative wound infusion 2 ml/h/48h

Protocol documents:
Clinical trial NCT01094717
Conditions: Psoriasis
Keywords: psoriasis excimer acitretin tazarotene
Sponsor: University of Utah
Start date: 2010-01-01; Completion date: 2011-10-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind study of excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily for plaque psoriasis.

The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD.

Detailed description:
The hypothesis of this study is that excimer (308-nm UVB) laser added to either tazarotene 0.1% gel or acitretin 25 mg daily will lead to improved efficacy of these treatments alone.

The primary objective of this study is to compare the improvement of psoriatic plaques with and without excimer laser (308-nm UVB) treatment, applied in a randomized and blinded fashion, in subjects on acitretin 25 mg or tazarotene gel 0.1% QD. The primary endpoint will be the comparison between the change in NPF score of plaques treated with excimer laser and those treated with sham treatment.

The secondary objectives are to compare the number of excimer light treatments and time necessary to achieve an average lesion assessment score of 0 to 1 in subjects treated with acitretin 25 mg PO or tazarotene gel 0.1% QD, and to evaluate adverse events related to combinations of the study treatments.

Arms: arm 1: patients enrolled in the acitretin arm will be treated with acitretin 25 mg daily and excimer (active) to randomly assigned left or right side of body psoriasis lesions. arm 2: Patients in this arm were treated with acitretin 25 mg daily and sham (placebo) excimer laser to randomly assigned left or right side of body psoriasis lesions. arm 3: patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and excimer (active) laser to randomly assigned left or right side of body psoriasis lesions. arm 4: patients enrolled in this arm were treated with tazarotene 0.1% gel topical application daily and sham excimer laser to randomly assigned left or right side of body psoriasis lesions.
Interventions: intervention 1: Acitretin 25Mg Oral Capsule intervention 2: Excimer laser intervention 3: Tazarotene 0.1% Gel,Top intervention 4: Sham excimer laser
Intervention descriptions: intervention 1: Acitretin 25 mg oral daily for 12 weeks intervention 2: Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser. intervention 3: Topical tazarotene 0.1% gel was applied daily to active lesions. intervention 4: Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).

Protocol documents:
Clinical trial NCT01096186
Conditions: Parkinson's Disease
Keywords: motor Symptoms efficacy IPX066 Parkinson's Disease
Sponsor: Impax Laboratories, LLC
Start date: 2010-03-01; Completion date: 2011-10-01
Enrollment: 617 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

Detailed description:
IPX066 is intended for chronic treatment of motor symptoms for all stages of PD. This study is designed to enroll subjects who have successfully completed one of the following studies of IPX066:

* IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease)
* IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa)
* IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)

All participants will be given IPX066 for 9 months.

Arms: arm 1: Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
Interventions: intervention 1: IPX066 95 mg intervention 2: IPX066 145 mg intervention 3: IPX066 195 mg intervention 4: IPX066 245 mg
Intervention descriptions: intervention 1: 23.75 - 95 mg CD-LD capsules intervention 2: 36.25 - 145 mg CD-LD capsules intervention 3: 48.75 - 195 mg CD-LD capsules intervention 4: 61.25 - 245 mg CD-LD capsules

Protocol documents:
Clinical trial NCT01097707
Conditions: Benign Prostatic Hyperplasia
Sponsor: Eli Lilly and Company
Start date: 2010-04-01; Completion date: 2011-10-01
Enrollment: 414 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine whether LY500307 helps symptoms of Benign Prostatic Hyperplasia (BPH)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: LY500307 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered orally, daily for 24 weeks intervention 2: Administered orally, daily for 24 weeks

Protocol documents:
Clinical trial NCT01107912
Conditions: Coronary Artery Disease
Keywords: Platelet function
Sponsor: Eli Lilly and Company
Start date: 2010-03-01; Completion date: 2011-10-01
Enrollment: 155 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The 5-milligram (mg) maintenance dose (MD) of prasugrel in very elderly patients with coronary artery disease produces a pharmacodynamic response within the same therapeutic range as 10-mg MD in non-elderly patients.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: prasugrel intervention 2: clopidogrel
Intervention descriptions: intervention 1: administered orally, daily for 12 days intervention 2: Administered orally, daily for 12 days

Protocol documents:
Clinical trial NCT01108341
Conditions: Non-Hodgkin's Lymphoma (NHL)
Sponsor: Cephalon
Start date: 2010-05-01; Completion date: 2011-10-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of the study is to determine the efficacy, as measured by overall response (complete response + partial response) of bendamustine in combination with ofatumumab in previously untreated patients with indolent B-Cell Non-Hodgkin's Lymphoma (NHL).

Detailed description:

Arms: arm 1: There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m\^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
Interventions: intervention 1: Bendamustine hydrochloride intervention 2: Ofatumumab
Intervention descriptions: intervention 1: Bendamustine will be administered at 90 mg/m\^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle. intervention 2: Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.

Protocol documents:
Clinical trial NCT01118845
Conditions: Non-Hodgkin's Lymphoma Lymphoma, Large Cell Diffuse, Mantle Cell Lymphoma, Lymphoma Follicular Lymphoma Large B-Cell, Diffuse
Keywords: Non-Hodgkin's lymphoma Lymphoma, Large B-Cell Diffuse, Mantle cell lymphoma, Lymphoma Follicular, Lymphoma Large B-Cell, Diffuse
Sponsor: SymBio Pharmaceuticals
Start date: 2010-04-01; Completion date: 2011-10-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the efficacy of SyB L-0501 in combination with rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma.

Detailed description:
Primary Objective is to determine the efficacy, as measured by overall response rate on the basis of Revised Response Criteria for Malignant Lymphoma, of SyB L-0501 at 120 mg/m\^2/day on day2 and 3 in combination with rituximab at 375 mg/m\^2 on day 1 of each 21-day cycle in patients with relapsed/refractory diffuse large B-cell lymphoma.

Arms: arm 1: None
Interventions: intervention 1: SyB L-0501 intervention 2: Rituximab
Intervention descriptions: intervention 1: The administration of SyB L-0501 at 120 mg/m\^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule.

SyB L-0501 60 mg/m\^2, 90 mg/m\^2 or 120 mg/m\^2/day on Day 2 and Day 3 will be followed by 18 days of observation. intervention 2: The administration of rituximab at 375 mg/m\^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.

Protocol documents:
Clinical trial NCT01127087
Conditions: Hyperoxaluria
Keywords: Hyperoxaluria Oxazyme oxalate enteric hyperoxaluria
Sponsor: Mayo Clinic
Start date: 2010-05-01; Completion date: 2011-10-01
Enrollment: 22 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hypothesis: Oral administration of the oxalate metabolizing enzyme Oxazyme (OC4) will degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract. In addition, by reducing oxalate concentrations in the gastrointestinal fluid, oxalate secretion from blood to the intestinal tract may be increased. Both effects would decrease blood levels of oxalate, and hence oxalate excretion in the urine.

Detailed description:
Oxazyme is an oxalate degrading compound that can potentially degrade food-borne oxalate and hence prevent its absorption from the gastrointestinal tract.

We propose a 20-patient open-label trial pilot study of one month of Oxazyme twice daily (1gm Oxazyme sachet dissolved in 150 ml water) among adult subjects with a history of calcium oxalate nephrolithiasis. Patients will be stratified into those with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB, n=10) and those with idiopathic hyperoxaluria (n=10). The patients will perform two, 24-hour, urine collections immediately before starting Oxazyme and on the last two days of the treatment period.

Arms: arm 1: Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).

Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily. arm 2: Subjects with idiopathic hyperoxaluria.

Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.
Interventions: intervention 1: Oxazyme
Intervention descriptions: intervention 1: Oxazyme (registered trademark) is a non-systemic orally delivered drug composed of recombinant oxalate decarboxylase (OxDC). It is formulated to enzymatically degrade available dietary oxalate prior to its absorption.

Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily.

Protocol documents:
Clinical trial NCT01134042
Conditions: Asthma
Keywords: Fluticasone propionate asthma vilanterol GW642444 Fluticasone furoate
Sponsor: GlaxoSmithKline
Start date: 2010-06-01; Completion date: 2011-10-01
Enrollment: 587 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare the efficacy and safety of fluticasone furoate/vilanterol (GW642444) inhalation powder administered once daily each evening with fluticasone furoate inhalation powder administered alone once daily each evening in adolescent and adult subjects 12 years of age and older with persistent bronchial asthma over a 24-week period.

Detailed description:

Arms: arm 1: Fluticasone furoate/vilanterol inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks arm 2: Fluticasone furoate inhalation powder once daily + Placebo inhalation powder twice daily for 24 weeks arm 3: Fluticasone propionate inhalation powder twice daily + Placebo inhalation powder once daily for 24 weeks
Interventions: intervention 1: Fluticasone Furoate/Vilanterol Inhalation Powder intervention 2: Fluticasone Furoate Inhalation Powder intervention 3: Fluticasone Propionate Inhalation Powder intervention 4: Placebo Inhalation Powder 1 intervention 5: Placebo Inhalation Powder 2
Intervention descriptions: intervention 1: Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks intervention 2: Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks intervention 3: Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks intervention 4: Placebo in novel dry powder inhaler once daily intervention 5: Placebo in Diskus inhaler twice daily

Protocol documents: