ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01118377
Conditions: Brainstem Glioma
Sponsor: Hoffmann-La Roche
Start date: 2007-05-01; Completion date: 2013-04-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study evaluated the effect of capecitabine and concomitant radiation therapy in children with newly diagnosed brainstem gliomas.

Detailed description:
The open-label phase 2 study NO21125 (NCT01118377) evaluated the progression-free survival, safety, and pharmacokinetics of capecitabine (Xeloda®) rapidly disintegrating tablets and concomitant radiation therapy in children and adolescent patients with newly diagnosed brainstem glioma. There were 2 phases to the study: A 9-week radiation phase, followed by a 2-week rest period, and a 9-week post-radiation phase. In the radiation phase, capecitabine 650 mg/m\^2 was administered orally twice daily for 9 weeks. Concomitantly, patients received radiation therapy (180 cGy fractions) 5 days a week for a total target dose of 56 Gy. During the 9-week post-radiation phase of the study, capecitabine 1250 mg/m\^2 was administered orally twice daily for 14 days followed by a 7-day rest period. This cycle of 14 days treatment followed by 7 days rest was repeated 2 additional times. The dose could be adjusted according to toxicity and body surface area.

The single-arm phase 1 study NO18517 (NCT00532948) assessed the maximum tolerated dose and dose-limiting toxicities of capecitabine (Xeloda®) administered concurrently with radiation therapy in children with newly diagnosed diffuse intrinsic brain stem gliomas and high grade gliomas. Patients in the phase 1 study NO18517 who were diagnosed with intrinsic brainstem glioma and who were treated at the established maximum tolerated dose of capecitabine 650 mg/m\^2/dose twice a day were included in the analyses of the phase 2 study NO21125.

The efficacy and safety results of study NO21125 are reported below.

Arms: arm 1: Participants received 9 weeks of capecitabine 650 mg/m\^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m\^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
Interventions: intervention 1: Capecitabine intervention 2: Radiation therapy
Intervention descriptions: intervention 1: Capecitabine was supplied as film-coated tablets. intervention 2: Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.

Protocol documents:
Clinical trial NCT01136382
Conditions: Asthma
Keywords: asthma, children, budesonide pMDI
Sponsor: AstraZeneca
Start date: 2010-07-01; Completion date: 2013-04-01
Enrollment: 304 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of the study is to investigate if budesonide pMDI 160 �g twice a day during 6 weeks is effective and safe in treating asthmatic children aged 6 to \<12 years

Detailed description:
Phase 2, double-blind, randomized, parallel-group, placebo-controlled, multicenter study, comparing budesonide pMDI 160 �g bid with placebo: a 6-week efficacy and safety study in children aged 6 to \<12 years with asthma

Arms: arm 1: Budesonide pMDI 160 ug bid (80 ug x 2 inhalations bid) arm 2: Placebo pMDI 2 inhalations bid
Interventions: intervention 1: budesonide intervention 2: placebo
Intervention descriptions: intervention 1: pMDI, inhalation, bid, 6 weeks intervention 2: pMDI, inhalation, bid, 6 weeks

Protocol documents:
Clinical trial NCT01161121
Conditions: Coronary Artery Disease
Keywords: Fractional flow reserve adenosine regadenoson
Sponsor: St. Louis University
Start date: 2010-07-01; Completion date: 2013-04-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if regadenoson is as safe and effective as adenosine when used in the cardiac catheterization lab during measurement of coronary flow reserve and fractional flow reserve. The study hypothesis is the assessment of Fractional Flow Reserve (FFR) in the catheterization lab can be performed with equivalent accuracy when hyperemia is induced with IV Regadenoson compared with IV Adenosine without compromising patient safety.

Detailed description:
Patients with clinical indications to be assessed by fractional flow reserve (FFR) will be included. Following diagnostic angiography in the catheterization lab, the patient will have a guide catheter placed in the artery to be assessed followed by placing a pressure guidewire down the coronary vessel and past the lesion of interest. FFR will be measured in the traditional manner, with intravenous adenosine infusing at 140 mcg/kg/min until maximal steady state hyperemia is reached. At this point, the FFR will be recorded as Pd (distal pressure from the pressure wire in the coronary artery) divided by Pa (proximal pressure from the guide catheter). The adenosine infusion will then be stopped and the patient's hemodynamics allowed to return to baseline. Once baseline state is again achieved, an intravenous bolus of regadenson (0.4 mg) will be given and FFR will be remeasured as the lowest steady state Pd/Pa. Patients will be enrolled at two sites, The University of Florida - where FFR will be measured alone, and Saint Louis University, where coronary flow will be measured simultaneously to evaluate the effect of regadenoson on coronary flow velocity as compared to adenosine. The primary endpoint of the study will be to compare the FFR achieved with adeonsine to that obtained with regadenoson.

Arms: arm 1: Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. Adenosine infusion will be administered at 140 mcg/kg for 2 minutes and once mean coronary flow velocity returns to within 15% of pre-dose value, Regadenoson IV bolus 0.4 mg/5 ml will be administered followed by a 5 cc normal saline flush.
Interventions: intervention 1: adenosine intervention 2: regadenoson
Intervention descriptions: intervention 1: Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes. intervention 2: Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.

Protocol documents:
Clinical trial NCT01167569
Conditions: Reperfusion Injury
Keywords: Free Radicals Ascorbic Acid Cardiac Surgery Prevention of Reperfusion Injury
Sponsor: Rutgers, The State University of New Jersey
Start date: 2007-10-01; Completion date: 2013-04-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It has been shown that the stress that occurs during cardiac surgery leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which may contribute to complications after surgery.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C on the outcome and complications after cardiac surgery.

Detailed description:
Patients undergoing cardiac surgery are at significant risk for multiple major complications beyond those associated with other major operations. Most patients survive these events, but up to 10% develop injury to organ systems including the kidneys, lungs, pancreas, brain, etc. It has been shown that the stress that occurs during this critical period (cardiac surgery) leads to early decrease of many of the body's resources such as Vitamin C (ascorbic acid) which seem to contribute to these complications.

This study will investigate the effects of high doses of intravenous (IV) Vitamin C administered before, during and after the cardiac surgery.

Arms: arm 1: Ascorbic Acid (Vitamin C) 10mg/kg x 2 in the operating room followed by Ascorbic Acid (Vitamin C) 5mg/kg every 4 hours x 48 hours. arm 2: 5% Dextrose Water or Normal Saline (placebo) x 2 in the operating room followed by 5 % Dextrose Water or NS (placebo) every 4 hours X 48 hours.
Interventions: intervention 1: Ascorbic Acid intervention 2: 5 % Dextrose Water or Normal Saline
Intervention descriptions: intervention 1: Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours. intervention 2: 100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.

Protocol documents:
Clinical trial NCT01171976
Conditions: Diabetic Macular Edema
Keywords: DME Diabetic macula edema RETAIN ranibizumab
Sponsor: Novartis Pharmaceuticals
Start date: 2010-09-01; Completion date: 2013-04-01
Enrollment: 373 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate that two investigational treatment regimens have the potential to result in a superior visual acuity improvement as compared to a ranibizumab pro re nata (PRN=as needed) treatment regimen.

Detailed description:

Arms: arm 1: On Day 1, all patients received an intravitreal injection with 0.5 mg ranibizumab and subsequently entered Phase A which comprised of monthly injections. Laser therapy was applied at Day 1. It could then be re-administered according to ETDRS criteria at any visit with 0.5 mg ranibizumab treatment if deemed necessary by the Treating Investigator with a minimal treatment interval between laser treatments of 3 months. Laser therapy was administered ≥ 30 minutes prior to the ranibizumab injection. arm 2: Patients received ranibizumab intravitreal injection therapy only. arm 3: Patients received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
Interventions: intervention 1: Ranibizumab
Intervention descriptions: intervention 1: Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.

Protocol documents:
Clinical trial NCT01180790
Conditions: Hepatitis C
Keywords: HCV Hepatitis C Genotype 1
Sponsor: Alexion Pharmaceuticals, Inc.
Start date: 2010-09-01; Completion date: 2013-04-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate safety, tolerability, and antiviral response of ACH-0141625 compared to standard of care in hepatitis C virus (HCV)-positive participants.

Detailed description:

Arms: arm 1: 200 mg ACH-0141625 for 28 days plus pegylated interferon (Peg-IFN) alpha-2a and ribavirin (RBV) for 48 weeks arm 2: 400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks arm 3: 800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks arm 4: Placebo for 28 days plus Peg-IFN alpha-2a plus RBV for 48 weeks arm 5: 200 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks arm 6: 400 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks arm 7: 800 mg ACH-0141625 for 12 weeks plus Peg-IFN and RBV for up to a total of 24 or 48 weeks
Interventions: intervention 1: ACH-0141625 (Sovaprevir) intervention 2: ACH-0141625 (Sovaprevir) intervention 3: ACH-0141625 (Sovaprevir) intervention 4: Placebo intervention 5: Pegylated Interferon alpha-2a intervention 6: Ribavirin
Intervention descriptions: intervention 1: 200 mg oral capsule once daily intervention 2: 400 mg oral capsule once daily intervention 3: 800 mg oral capsule once daily intervention 4: Powder in capsule once daily intervention 5: 180 micrograms (ug) once a week by subcutaneous injection intervention 6: 400 mg or 600 mg (morning \[AM\]) and 600 mg (evening \[PM\]) capsules taken orally twice daily

Protocol documents:
Clinical trial NCT01184989
Conditions: Arthroplasty, Replacement Prevention of Venous Thromboembolism Moderate Renal Impairment (CrCl 30-50 mL/Min)
Sponsor: Boehringer Ingelheim
Start date: 2010-08-01; Completion date: 2013-04-01
Enrollment: 142 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To supplement the current evidence of the effect of Pradaxa® (dabigatran etexilate) on coagulation parameters, including a calibrated thrombin time test, in patients with moderate renal impairment undergoing elective total hip- or knee-replacement surgery, this PK/PD study will be conducted.

Detailed description:

Arms: arm 1: open label, once daily dose approved by EMEA and Health Canada
Interventions: intervention 1: Dabigatran etexilate
Intervention descriptions: intervention 1: once daily approved dose by EMEA and Health Canada

Protocol documents:
Clinical trial NCT01185340
Conditions: Major Depressive Disorder
Keywords: Depression MDD
Sponsor: Eli Lilly and Company
Start date: 2011-03-01; Completion date: 2013-04-01
Enrollment: 1056 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess whether LY2216684 12 milligrams (mg) or 18 mg flexible dose once daily is superior to placebo once daily in the adjunctive treatment of participants with major depressive disorder (MDD) who are partial responders to their selective serotonin reuptake inhibitor (SSRI) treatment.

Detailed description:
Following the Confirmation (CF) Phase, participants were randomized to adjunctive LY2216684 or adjunctive placebo if they had \<25% improvement in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over the past 3 weeks and a current MADRS total score ≥14. Participants who did not meet criteria received adjunctive placebo to preserve the blind.

Arms: arm 1: LY2216684: flexible dose of 12 or 18 milligrams (mg), administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Prior to entering the Adjunctive Treatment (AT) Phase, participants completed a 3-week Confirmation (CF) Phase where they received placebo (administered orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to the LY2216684 treatment arm.

For the first 2 weeks of the AT Phase, participants received a starting dose of 12 mg QD. Then, based on efficacy and tolerability, the dose could be increased to 18 mg QD over the next 6 weeks. Participants who had their dose increased to 18 mg QD could have had their dose decreased to 12 mg QD. Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase.

During the 1-week abrupt DC Phase, participants maintained their SSRI treatment. arm 2: Placebo: Administered orally, once daily (QD) for 8 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)

Prior to entering the Adjunctive Treatment (AT) Phase, participants completed a 3-week Confirmation (CF) Phase where they received placebo (administered orally, QD) adjunctive to their SSRI. After the CF Phase, and after randomization criteria were met, participants were randomized to the placebo treatment arm.

During the AT Phase, participants received placebo (administered orally, QD) adjunctive to their SSRI for 8 weeks. Participants who completed the AT Phase or discontinued early had the option to enter the Discontinuation (DC) Phase.

During the 1-week abrupt DC Phase, participants maintained their SSRI treatment.
Interventions: intervention 1: LY2216684 intervention 2: Placebo intervention 3: SSRI
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study

Protocol documents:
Clinical trial NCT01188694
Conditions: Chronic Posttraumatic Stress Disorder
Sponsor: University of Washington
Start date: 2009-09-01; Completion date: 2013-04-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety. There are several effective therapies for PTSD, but they are often time consuming. The investigators want to see if the investigators can shorten treatment time while keeping therapy effective by adding a medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To examine whether medication plus psychotherapy helps with depression, trauma-related cognitions, and functioning.

Detailed description:
The psychotherapy the investigators are offering in this study is a type of cognitive behavioral therapy called imaginal exposure. In imaginal exposure, the investigators encourage the client to approach the memory of the trauma by recounting the trauma story to the therapist and discussing his or her reactions to the memory.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Psychotherapy plus Methylene Blue, USP intervention 2: Psychotherapy plus Placebo intervention 3: Delayed Psychotherapy
Intervention descriptions: intervention 1: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given. intervention 2: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given. intervention 3: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).

Protocol documents:
Clinical trial NCT01190254
Conditions: Schizophrenia, Paranoid Schizophrenia, Disorganized Schizophrenia, Undifferentiated
Keywords: Asenapine adolescents schizophrenia phase IIIb placebo-controlled
Sponsor: Organon and Co
Start date: 2010-09-28; Completion date: 2013-04-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily \[BID\]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.

Detailed description:

Arms: arm 1: Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks. arm 2: Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period. arm 3: Participants receive placebo asenapine tablets sublingually BID for 8 weeks.
Interventions: intervention 1: asenapine 2.5 mg intervention 2: asenapine 5.0 mg intervention 3: placebo
Intervention descriptions: intervention 1: asenapine 2.5 mg tablets for sublingual administration intervention 2: asenapine 5.0 mg tablets for sublingual administration intervention 3: asenapine-matched placebo tablets for sublingual administration

Protocol documents:
Clinical trial NCT01198795
Conditions: Major Depressive Disorder
Keywords: depression major depressive disorder escitalopram Lexapro pediatric
Sponsor: Forest Laboratories
Start date: 2010-09-01; Completion date: 2013-04-01
Enrollment: 162 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the long-term safety and tolerability of escitalopram (Lexapro) in children 7 to 11 years of age with major depressive disorder (MDD).

Detailed description:

Arms: arm 1: Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.

Protocol documents:
Clinical trial NCT01206322
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes, blood flow, brain perfusion, cognitive function
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2010-05-01; Completion date: 2013-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Our goal is to determine the acute effects of intranasal insulin on regional perfusion and cognition of older adults. We propose a pilot study to examine the effect of a single dose of intranasal insulin on regional vasoreactivity and cognitive functions in 30 subjects with T2DM and 30 healthy controls \>50 years old using a double blinded, placebo-controlled, cross-over design.

Hypothesis 1: Intranasal insulin improves acutely regional perfusion and vasoreactivity in older patients with T2DM as compared with placebo and compared with the control group.

Hypothesis 2: Intranasal insulin improves cognitive functioning including attention, memory and executive function in diabetic patients as compared with placebo and compared with control group.

Detailed description:
Type 2 diabetes mellitus (T2DM) is a major risk factor for vascular dementia. DM alters insulin transport across blood-brain barrier affecting perfusion and neuronal function. Intranasal administration enables effective delivery of insulin to the brain. Clinical studies demonstrated improvement of cognitive function and memory in healthy and cognitively impaired people.

Aim 1: To determine the acute effects of a single 40-IU dose of intranasal insulin vs. placebo on regional perfusion and vasoreactivity to CO2 challenge measured by 3-D continuous arterial spin labeling (CASL) MRI at 3 Tesla in the control and diabetic groups. We will use transcranial Doppler to determine the effects on intranasal insulin vs. placebo on cerebral autoregulation based on measurements of beat-to-beat pressure flow velocity relationship.

Aim 2: To determine whether intranasal insulin improves cognitive functioning in older T2DM patients as compared with placebo and the control group.

This translational study will address an important area about the effects of intranasal insulin on cerebral blood flow regulation and cognition in older diabetics that has not been studied. Intranasal insulin administration may provide a novel therapeutic target for prevention and treatment of microvascular disease and cerebrovascular complications of T2DM. If successful, this approach may have significant impact on the clinical management of large population of older adults with T2DM.

Arms: arm 1: Comparisons of acute effects of intranasal insulin or placebo (saline) on cerebral blood flow and cognition in healthy controls and type 2 diabetes. arm 2: Comparisons of acute effects of intranasal insulin or placebo (saline) on cerebral blood flow and cognition in healthy controls and type 2 diabetes.
Interventions: intervention 1: Intranasal insulin intervention 2: Placebo
Intervention descriptions: intervention 1: The acute effects of a single 40-IU dose of intranasal insulin intervention 2: The acute effects of intranasal sterile saline.

Protocol documents: