ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01027468
Conditions: Neovascular Age-related Macular Degeneration
Keywords: bevacizumab, choroidal neovascularization
Sponsor: Medical University of Vienna
Start date: 2009-08-01; Completion date: 2009-12-01
Enrollment: 160 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
200 eyes with each subtype of neovascular age-related macular degeneration will be included in this study and 3 years after the initial intravitreal bevacizumab, best-corrected visual acuity (BCVA) will be measured using Snellen charts at 6m. Central retinal thickness (CRT) will be measured using Stratus OCT and Cirrus SD-OCT (Zeiss). Data of treatment-naive eyes (group 1) were compared to the data of eyes that had undergone prior treatment with photodynamic therapy with verteporfin and intravitreal triamcinolone acetonide (group 2).

Detailed description:
In this interventional clinical study, 181 eyes of 160 consecutive patients with active neovascular related macular degeneration meeting recommended criteria for inclusion and protocol criteria for anti-vascular endothelial growth factor therapy undergoing intravitreal bevacizumab monotherapy were evaluated. Data of treatment-naive eyes (Group 1, n = 114) were analyzed separately from eyes that had undergone previous photodynamic therapy plus intravitreal triamcinolone (Group 2, n = 67). Re-treatment criteria were based on clinical outcome following the official European label regimen. After 1 year of continuous service at an academic referral center, follow-up was performed in private practices in collaboration with the referral center. Main outcome parameters were best-corrected visual acuity and central retinal thickness.

Arms: arm 1: bevacizumab intravitreal injection
Interventions: intervention 1: Bevacizumab
Intervention descriptions: intervention 1: intraocular bevacizumab injection

Protocol documents:
Clinical trial NCT01039584
Conditions: Vulvovaginal Candidiasis
Keywords: bioequivalence butoconazole vulvovaginal candidiasis
Sponsor: Padagis LLC
Start date: 2008-02-01; Completion date: 2009-12-01
Enrollment: 611 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a study that compared the efficacy and safety of a generic butoconazole nitrate vaginal cream, 2% to Gynazole-1 (butoconazole nitrate) Vaginal Cream, 2% in the treatment of vulvovaginal candidiasis caused by Candida species.

Detailed description:

Arms: arm 1: vehicle of the test product; applied intravaginally once within 48 hours of randomization arm 2: Butoconazole Nitrate Vaginal Cream; applied intravaginally once within 48 hours of randomization arm 3: Gynazole 1 Vaginal Cream; applied intravaginally once within 48 hours of randomization
Interventions: intervention 1: Butoconazole Nitrate Vaginal Cream intervention 2: Placebo intervention 3: Gynazole 1 vaginal cream
Intervention descriptions: intervention 1: vaginal cream intervention 2: vaginal cream intervention 3: vaginal cream

Protocol documents:
Clinical trial NCT01064167
Conditions: Off Pump Coronary Artery Bypass Surgery
Keywords: Tranexamic Acid off-pump coronary Artery Bypass
Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Start date: 2009-02-01; Completion date: 2009-12-01
Enrollment: 231 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this prospective, randomized, double-blinded, placebo-controlled study was to evaluate the effects of tranexamic acid, a synthetic antifibrinolytic drug, on the postoperative bleeding and transfusion requirements in patients undergoing off-pump coronary artery bypass graphing (OPCAB) surgery.

Detailed description:
Cardiac surgical procedures account for a large amount of allogeneic transfusion. Although postoperative bleeding seems to be attenuated by the avoidance of cardiopulmonary bypass (CPB), hemorrhagic complications are not completely eliminated and the consequent need for allogeneic transfusions are still major problems after OPCAB.

Tranexamic acid, a synthetic antifibrinolytic drug, has been shown to reduce blood loss and transfusion requirements in cardiac surgery with CPB. About 30% of patients in OPCAB studies still receive a transfusion. A few small sample size studies concerned with the use of in OPCAB surgery, found that tranexamic acid appear to be effective in reducing postoperative bleeding, however, the results on transfusion requirements are still inconsistency. The purpose of this study was to evaluate the effects of tranexamic acid on the postoperative bleeding and transfusion requirements in a larger number of patients undergoing OPCAB surgery. In addition, the effect of tranexamic acid on mortality, morbidity and resource utilization was examined.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tranexamic Acid
Intervention descriptions: intervention 1: In tranexamic acid group, tranexamic acid, 1 g, was given 20 minutes before incision and 400 mg/h during the entire surgical procedure. The patients from control group were infused with normal saline as a placebo.

Protocol documents:
Clinical trial NCT01087801
Conditions: Pancreatic Disease
Keywords: Genetic End Marker
Sponsor: ChiRhoClin, Inc.
Start date: 2007-10-01; Completion date: 2009-12-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The following are the study hypothesis:

* Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples being predominantly of exocrine pancreas origin when samples are duodenal aspirates.
* Secretin administration compared to placebo will result in a statistically significantly greater percentage of collected fluid samples meeting the minimum specifications for use in the indicated laboratory test of DNA mutational analysis.

Detailed description:

Arms: arm 1: Human Secretin for Injection arm 2: Saline for Injection
Interventions: intervention 1: ChiRhoStim intervention 2: Placebo
Intervention descriptions: intervention 1: Human Secretin for Injection intervention 2: Saline for Injection

Protocol documents:
Clinical trial NCT01155219
Conditions: Glaucoma
Keywords: Bilateral Glaucoma Bilateral ocular hypertension Bilateral primary open angle glaucoma Bilateral ocular hypertension already treated and controlled by mono-therapy of Xalatan® (1drop per day) With local intolerance signs in at least one eye
Sponsor: Laboratoires Thea
Start date: 2008-07-01; Completion date: 2009-12-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This phase IV study aims to assess the safety and the efficacy in intra ocular pressure of Geltim LP® 1 mg/g (0.1% unpreserved timolol maleate gel) in glaucomatous patients initially treated and stabilised by monotherapy of Xalatan® with ocular objective signs of intolerance to prostaglandin eye drops.

Detailed description:
The primary objectives are to compare the safety and the efficacy of Geltim LP® 1mg/g eye drops versus Xalatan® eye drops with respect to:

The assessment of the ocular tolerance:

* Ocular symptoms
* Objective ocular signs.

The maintain of the IOP efficient lowering effect. Comparison between the 2 study products of the mean basal IOP after a 12 weeks treatment period (84 days ±7).

Arms: arm 1: Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days). arm 2: Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.
Interventions: intervention 1: Geltim LP 1 mg/g intervention 2: Xalatan
Intervention descriptions: intervention 1: one drop in the conjunctival sac of each eye in the morning (84 days). intervention 2: one drop in the conjunctival sac of each eye in the morning (84 days).

Protocol documents:
Clinical trial NCT01192139
Conditions: Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2009-11-01; Completion date: 2009-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana \[IN\]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects.

Detailed description:
This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/500 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, Indiana)

Arms: arm 1: None arm 2: under fed state arm 3: under fasted state
Interventions: intervention 1: saxagliptin intervention 2: metformin XR intervention 3: saxagliptin + metformin XR (FDC tablet)
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, once daily, Single dose intervention 2: Tablets, Oral, 500 mg. once daily, Single dose intervention 3: Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose

Protocol documents:
Clinical trial NCT01192152
Conditions: Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2009-11-01; Completion date: 2009-12-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in Evansville, Indiana) in the fed state in healthy subjects.

Detailed description:
This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/1000 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin tablet plus 2 x 500 mg Glucophage XR tablets (manufactured in Evansville, Indiana)

Arms: arm 1: None arm 2: under fed state, single dose arm 3: under fed state, 4 days
Interventions: intervention 1: saxagliptin intervention 2: Glucophage XR intervention 3: saxagliptin + metformin XR (FDC tablet)
Intervention descriptions: intervention 1: Tablets, Oral, 5 mg, once daily, Single dose intervention 2: Tablets, Oral, 500 mg, once daily, Single dose intervention 3: Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days

Protocol documents:
Clinical trial NCT01235923
Conditions: Preterm Infants
Keywords: anemia transfusions erythropoiesis neonate preterm
Sponsor: University of New Mexico
Start date: 2006-04-01; Completion date: 2009-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing usually occurs three times a week, but extended dosing schedules have been successful in adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard three times weekly dosing.

Detailed description:
Erythropoietin (Epo) increases and maintains hematocrit using once weekly dosing in adults with anemia due to end stage renal disease. Epo is used in preterm infants to treat the anemia of prematurity, but has not been studied using once weekly dosing. We compared reticulocyte responses of once weekly Epo dosing with thrice weekly dosing in preterm infants.

Infants ≤1,500 grams and ≥7 days of age were randomized to once weekly Epo, 1,200 units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation. Complete blood counts, absolute reticulocyte counts (ARC), transfusions, phlebotomy losses, and adverse events were recorded.

Arms: arm 1: Epo 400 units/kg three times weekly given subcutaneously for 4 weeks arm 2: 1,200 units/kg given once a week subcutaneously for 4 weeks
Interventions: intervention 1: three times weekly Epo intervention 2: weekly Epo
Intervention descriptions: intervention 1: Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks intervention 2: Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks

Protocol documents:
Clinical trial NCT01237327
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer Advanced Postmenopausal Exemestane vs Megestrol
Sponsor: Pfizer
Start date: 2001-11-01; Completion date: 2009-12-01
Enrollment: 84 participants; Allocation: ; Intervention model: PARALLEL

Brief summary:
Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Megestrol acetate intervention 2: exemestane (Aromasin)
Intervention descriptions: intervention 1: Megestrol Acetate 160 mg oral tablets Qd intervention 2: exemestane (Aromasin) 25 mg oral tablets Qd

Protocol documents:
Clinical trial NCT01243580
Conditions: Healthy
Keywords: PK and safety Pharmacokinetic profile (PK) and safety
Sponsor: Agile Therapeutics
Start date: 2009-08-01; Completion date: 2009-12-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Pharmacokinetics and safety of AG200-15 over two consecutive cycles of therapy will be evaluated.

Detailed description:
This is an open-label study comprised of two parts. Part I is a single-arm, run-in cycle with AG200-15 administered to all subjects as a 21-7 day regimen (three consecutive weeks of patch wear followed by a patch-free week).

Part II employs crossover design with subjects randomly assigned to one of the two treatment sequences. Each sequence will include AG200-15 and oral contraceptive (Ortho-Cyclen®) as described below: Sequence 1: AG200-15 (Period 1) followed by oral contraceptive, Ortho-Cyclen® (Period 2); Sequence 2: Oral contraceptive, Ortho-Cyclen® (Period 1) followed by AG200-15 (Period 2) Both AG200-15 and Ortho-Cyclen® will be administered as 21-7 day regimen (three consecutive weeks of drug-taking followed by a drug-free week). Duration of each treatment Period is 28 days (one cycle of therapy).

Arms: arm 1: Ortho-Cyclen® is a comparator drug intervention arm 2: AG200-15 is an investigational transdermal contraceptive delivery system that is a drug intervention
Interventions: intervention 1: Ortho-Cyclen intervention 2: AG200-15
Intervention descriptions: intervention 1: Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen. intervention 2: AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE

Protocol documents:
Clinical trial NCT01461733
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation amiodarone
Sponsor: Ottawa Hospital Research Institute
Start date: 2007-07-01; Completion date: 2009-12-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.

The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.

Detailed description:
see above

Arms: arm 1: standard dose amiodarone arm 2: None
Interventions: intervention 1: amiodarone intervention 2: Placebo
Intervention descriptions: intervention 1: standard dose amiodarone intervention 2: placebo delivered blinded

Protocol documents:
Clinical trial NCT01721564
Conditions: Pulmonary Arterial Hypertension
Sponsor: Prof David S Celermajer
Start date: 2006-04-01; Completion date: 2009-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.

Detailed description:

Arms: arm 1: 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
Interventions: intervention 1: Bosentan
Intervention descriptions: intervention 1: 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months

Protocol documents:
Clinical trial NCT01869959
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2009-04-01; Completion date: 2009-12-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, the study lasted about 2 months for each participant. Participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.

Detailed description:

Arms: arm 1: Participants received placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days. arm 2: Participants received 3 milligrams (mg) LY2405319 injected SC once daily for 28 days. arm 3: Participants received 10 mg LY2405319 injected SC once daily for 28 days. arm 4: Participants received 20 mg LY2405319 injected SC once daily for 28 days.
Interventions: intervention 1: LY2405319 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered SC intervention 2: Administered SC

Protocol documents:
Clinical trial NCT01907113
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2009-07-01; Completion date: 2009-12-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assessment of the effect of normal and impaired kidney function on the pharmacokinetics, pharmacodynamics and safety of BI 10773

Detailed description:

Arms: arm 1: Single Dose Administration (type 2 diabetes and mild renal impairment) arm 2: Single Dose Administration (type 2 diabetes and moderate renal impairment) arm 3: Single Dose Administration (severe renal impairment 8) arm 4: Single Dose Administration (kidney failure) arm 5: Single Dose Administration (type 2 diabetes and normal renal function)
Interventions: intervention 1: BI 10773 intervention 2: BI 10773 intervention 3: BI 10773 intervention 4: BI 10773 intervention 5: BI 10773
Intervention descriptions: intervention 1: oral administration intervention 2: oral administration intervention 3: oral administration intervention 4: oral administration intervention 5: oral administration

Protocol documents:
Clinical trial NCT02176525
Conditions: Hepatitis C, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2007-12-01; Completion date: 2009-12-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to investigate antiviral activity, safety and pharmacokinetics of 5 days of monotherapy with BI 207127 in HCV genotype 1 (GT1) infected patients. Both treatment-naïve patients and patients previously treated with peginterferon and ribavirin were included. In addition, the effect of study medication was examined in a group of patients with liver cirrhosis.

Detailed description:

Arms: arm 1: multiple rising doses arm 2: multiple rising doses arm 3: None
Interventions: intervention 1: BI 207127 NA intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02582983
Conditions: HIV Infections
Sponsor: Hoffmann-La Roche
Start date: 2004-02-01; Completion date: 2009-12-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study assessed the safety and tolerability of enfuvirtide in participants with advanced HIV genotype 1 (HIV-1) disease. Eligible participants who failed treatment with regimens containing at least one product from each anti-retroviral class, or had experienced intolerance to previous anti-retroviral regimens received enfuvirtide, 90 milligrams (mg) subcutaneously (SC) twice daily (BID) as long as there were no enfuvirtide related treatment limiting toxicities and participants benefited from study treatment as per investigator's discretion. The anticipated time on study treatment was based on the commercial availability of enfuvirtide in Thailand, and the target sample size was 30 individuals.

Detailed description:

Arms: arm 1: Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID).
Interventions: intervention 1: Enfuvirtide
Intervention descriptions: intervention 1: All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.

Protocol documents:
Clinical trial NCT00621244
Conditions: Lymphoma Leukemia Multiple Myeloma
Keywords: HDAC inhibitor Oral LBH589 Lymphoma Leukemia Multiple myeloma
Sponsor: Novartis Pharmaceuticals
Start date: 2003-03-01; Completion date: 2009-12-03
Enrollment: 175 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: Panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y is a sub-arm, based on disease indication.
Interventions: intervention 1: LBH589
Intervention descriptions: intervention 1: None

Protocol documents: