ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02813070
Conditions: Mild Cognitive Impairment Alzheimer's Disease Healthy
Sponsor: GE Healthcare
Start date: 2012-10-01; Completion date: 2013-05-01
Enrollment: 70 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase 2, multicenter study to assess the extent and patterns of \[18F\] flutemetamol uptake in the brains of 3 groups of Japanese subjects: healthy volunteers (HV), amnestic mild cognitive impairment (aMCI), and probable Alzheimer's disease (pAD), and to assess the reproducibility of brain uptake and of image interpretation. Subjects underwent open-label intravenous (i.v.) administration of Flutemetamol F 18 Injection and Positron emission tomography (PET) imaging of the brain. Blinded visual image reads were performed by 10 independent board-certified readers (5 Japanese and 5 non-Japanese) with nuclear medicine image interpretation experience. The blinded visual assessments were compared with the subject's clinical diagnoses, and the agreement between the image interpretations made by the 2 groups of readers (Japanese and non-Japanese) was determined.

Detailed description:
This was a Phase 2, multicenter study to assess the extent and patterns of \[18F\] flutemetamol uptake in the brains of 3 groups of Japanese subjects: HV, aMCI, and pAD, and to assess the reproducibility of brain uptake and of image interpretation. The 3 comparison groups (HV, aMCI, and pAD) were defined by the subjects' main clinical diagnoses at study entry. Subjects underwent diagnostic quality anatomic brain magnetic resonance imaging (MRI), followed by open-label intravenous (i.v) administration of Flutemetamol F 18 Injection and PET imaging of the brain. Blinded visual image reads were performed by 10 independent board-certified readers (5 Japanese and 5 non-Japanese) with nuclear medicine image interpretation experience. The blinded visual assessments were compared with the subject's clinical diagnoses, and the agreement between the image interpretations made by the 2 groups of readers (Japanese and non-Japanese) was determined. Blinded visual assessments were also compared to quantitative image assessments (standardized uptake value ratio \[SUVRs\]). Inter-reader and intra-reader agreement was also assessed. Test-retest variability was evaluated following a second administration of Flutemetamol F 18 Injection given to a subset (N=5) of pAD subjects between 1 and 4 weeks after their first administration of Flutemetamol F 18 Injection.

Arms: arm 1: 185 MBq \[18F\] Flutemetamol arm 2: 185 MBq \[18F\] Flutemetamol arm 3: 185 MBq \[18F\] Flutemetamol
Interventions: intervention 1: [18F] Flutemetamol
Intervention descriptions: intervention 1: PET brain imaging and Magnetic resonance brain imaging

Protocol documents:
Clinical trial NCT04051684
Conditions: Bariatric Surgery Transverse Abdominal Plane Regional Blocks
Sponsor: Montefiore Medical Center
Start date: 2013-04-01; Completion date: 2013-05-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI \>35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room

Detailed description:

Arms: arm 1: This group will receive general anesthesia and at the end of the operation, but still in the operating room, a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. arm 2: General anesthesia
Interventions: intervention 1: Transverse abdominal plane block intervention 2: Ropivacaine
Intervention descriptions: intervention 1: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle. intervention 2: Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.

Protocol documents:
Clinical trial NCT01287195
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis Inflammatory Bowel Disease
Sponsor: Brigham and Women's Hospital
Start date: 2011-04-07; Completion date: 2013-05-02
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the safety and efficacy of orally delivered short-term OKT3 in participants with active ulcerative colitis.

Detailed description:
Ulcerative colitis (UC) is a chronic disease of unknown etiology characterized by infiltration of inflammatory cells into the intestinal tract. OKT3 is an approved drug for intravenous use in the treatment of solid-organ transplantation. However, intravenous dosing has been limited by significant toxicities. Data from animal models suggest that antibody recognizing the T3 antigen complex Cluster of Differentiation 3 (anti-CD3) administered via the oral route is effective at treating a variety of autoimmune diseases. No side effects were observed in a recent phase I study of healthy participants receiving oral anti-CD3 monoclonal antibody (mAb).

The objectives of the current study are to assess the safety, immunologic effects and efficacy of short-term oral administration of OKT3 in participants with active ulcerative colitis. OKT3 will be delivered orally as a 1 milligram (mg) or 2 mg dose with Omeprazole 20 mg daily for 30 consecutive days in an open-label pilot trial. Thirty two participants will be screened for a targeted completion of 16 enrolled participants. The participants will be evaluated at baseline, day 1, day 2, week 1, week 3, as well as after completion of therapy at week 5 and 10 after the initiation of treatment. Lab tests will be performed at screening, baseline, day 2, week 1, week 3, week 5 and week 10. Clinical data will be collected at all study visits and via diary entries throughout the study period. A flexible sigmoidoscopy will be done at baseline and at week 5. Stool studies will be performed at screening to rule out infection.

To be eligible for this study, participants must be between the ages of 18 and 65 years and have a history of moderately to severely active UC as defined by a Mayo score of 6 to 12. They may not be taking concurrent biologic or immunomodulator therapy for UC.

Arms: arm 1: Participants with ulcerative colitis will receive Oral OKT3 given with Omeprazole once daily for 30 days.
Interventions: intervention 1: Oral OKT3 intervention 2: Omeprazole
Intervention descriptions: intervention 1: 1 mg or 2 mg Oral OKT3 will be given orally to participants once daily for 30 days intervention 2: 20 mg Omeprazole will be given orally to participants once daily for 30 days

Protocol documents:
Clinical trial NCT01518309
Conditions: Parkinson's Disease Psychosis
Sponsor: ACADIA Pharmaceuticals Inc.
Start date: 2004-11-17; Completion date: 2013-05-02
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label extension study to assess the long-term safety and tolerability of pimavanserin (ACP-103) in subjects with Parkinson's Disease Psychosis (PDP).

Detailed description:

Arms: arm 1: Tablets taken once daily by mouth at 20, 40, or 60 mg doses
Interventions: intervention 1: pimavanserin tartrate (ACP-103)
Intervention descriptions: intervention 1: Tablets taken once daily by mouth at 20, 40, or 60 mg doses

Protocol documents:
Clinical trial NCT01842620
Conditions: Diabetes Mellitus, Type 2
Keywords: Metformin Bioequivalence
Sponsor: GlaxoSmithKline
Start date: 2013-03-13; Completion date: 2013-05-04
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open-label, single-center, randomized, 2-way crossover study to evaluate the bioequivalence of OXEMET™ 1000 mg coated tablets, relative to 1000 mg of the reference product administered as two 500 mg tablets, under fasting conditions, in 24 healthy adult subjects. Each subject will receive two treatments (Treatment A and Treatment B). In Period 1, subjects will be dosed with either one OXEMET™ 1000 mg tablet (Treatment A, Test) or two 500 mg tablets of reference product (GLAFORNIL™ 500 mg) (Treatment B, Reference). Following a washout of at least 7 days, subjects will be crossed over in Period 2 to receive the treatment that they did not receive in Period 1.

Detailed description:

Arms: arm 1: Generic undergoing bioequivalence study against reference arm 2: Reference drug for bioequivalence study
Interventions: intervention 1: Metformin
Intervention descriptions: intervention 1: Oral antidiabetic agent

Protocol documents:
Clinical trial NCT00184002
Conditions: Non-Hodgkin's Lymphoma
Sponsor: University of Southern California
Start date: 2003-01-10; Completion date: 2013-05-07
Enrollment: 68 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.

Detailed description:

Arms: arm 1: On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5.

On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5

* 1 cycle = 21 days.
* Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.
Interventions: intervention 1: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone
Intervention descriptions: intervention 1: Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min.

Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min.

Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum).

Prednisone 100 mg po days 1-5.

Cycle 2 until study completion

Doxil 40 mg/m2 iv day 1

Rituxan 375 mg/m2 iv day 1

Cyclophosphamide 750 mg/m2 iv day 1

Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum)

Prednisone 100 mg po days 1-5

* 1 cycle = 21 days.
* Continue treatment until 2 cycles beyond documentation of CR for a maximum of 8 cycles.

Protocol documents:
Clinical trial NCT01587898
Conditions: Anaemia
Keywords: Anemia Prolyl hydroxylase inhibitor Hemoglobin Chronic kidney disease pharmacokinetics recombinant human erythropoietin GSK1278863
Sponsor: GlaxoSmithKline
Start date: 2012-05-17; Completion date: 2013-05-07
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia associated with chronic kidney disease who are not taking rhEPO and are not undergoing dialysis. The range of Hgb values for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion.

Detailed description:
This is a four-week Phase IIa, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the safety, efficacy and pharmacokinetics of GSK1278863 in approximately 68 subjects with anemia associated with chronic kidney disease who are not taking rhEPO and are not undergoing dialysis. The study consists of a screening phase of up to 2 weeks, a 4-week treatment phase and a 2-week follow-up phase. The range of Hgb values for study eligibility is 8.5-11.0 g/dL. Eligible subjects will be randomized in equal proportions to receive once daily (QD) placebo or GSK1278863 0.5 mg, 2 mg or 5 mg in a double-blind fashion. Study treatment will be stopped if Hgb values fall outside of the range pre-specified in the protocol.

This study aims to estimate the relationship between dose of GSK1278863 and Hgb response for correcting anemia in non-dialysis subjects with CKD who are not taking rhEPO (NDD). In addition, the study will characterize the effect of GSK1278863 on various pharmacokinetic/pharmacodynamic (PK/PD) markers, and will investigate the safety and tolerability of GSK1278863.

An early interim analysis of the Hgb data is planned after approximately 20 subjects from cohort 1 have completed 3 weeks of treatment. Depending upon the interim findings, a second cohort of subjects may be added to investigate an additional GSK1278863 dose arm. Recruitment to the first cohort will continue during the interim analysis.

A second interim analysis is planned after approximately 48 subjects from cohort 1 have completed 4 weeks treatment. The purpose of this interim is three-fold, to investigate whether a second cohort of subjects may be added, to facilitate early development of dose-response and PK/PD statistical models, and to generate interim results to facilitate design and dosing decisions for the next trial.

Subject completion is defined as completion of all study phases including the follow-up phase.

Arms: arm 1: Once daily arm 2: Once daily arm 3: Once daily arm 4: Once daily
Interventions: intervention 1: GSK1278863 intervention 2: Placebo
Intervention descriptions: intervention 1: Tablet intervention 2: Tablet

Protocol documents:
Clinical trial NCT01431638
Conditions: Acute Gouty Arthritis
Keywords: Gout arthritis gout flare acute gout gouty rheumatic disease uric acid podagra
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-25; Completion date: 2013-05-09
Enrollment: 397 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Detailed description:

Arms: arm 1: Canakinumab 150mg in prefilled syringe subcutaneously
Interventions: intervention 1: Canakinumab 150mg in prefilled syringe
Intervention descriptions: intervention 1: Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Protocol documents:
Clinical trial NCT01254604
Conditions: Glaucoma Ocular Hypertension
Keywords: Tafluprost Glaucoma Ocular Hypertension Timolol Eye Disorder Preservative-Free Prostaglandin Analogue
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-12-01; Completion date: 2013-05-09
Enrollment: 190 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm. arm 2: One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
Interventions: intervention 1: Preservative-Free Tafluprost or vehicle intervention 2: Preservative-Free Timolol maleate
Intervention descriptions: intervention 1: Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug) intervention 2: Preservative-free timolol maleate (0.5%) ophthalmic solution

Protocol documents:
Clinical trial NCT00907296
Conditions: Fracture Healing
Keywords: Fracture Healing Tibial Diaphyseal Fracture
Sponsor: Amgen
Start date: 2009-09-02; Completion date: 2013-05-10
Enrollment: 402 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to investigate the effect of romosozumab compared with placebo on time to radiographic healing of fresh tibial diaphyseal fractures (fractures in the midsection of the shinbone).

Detailed description:

Arms: arm 1: Participants received subcutaneous injections of matching placebo on day 1 and at weeks 2, 6, and 12. arm 2: Participants received subcutaneous injections of 70 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12. arm 3: Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12. arm 4: Participants received subcutaneous injections of 70 mg romosozumab on day 1 and weeks 2, 6, and 12. arm 5: Participants received subcutaneous injections of 140 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12. arm 6: Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12. arm 7: Participants received subcutaneous injections of 140 mg romosozumab on day 1 and weeks 2, 6, and 12. arm 8: Participants received subcutaneous injections of 210 mg romosozumab on day 1 and week 2, and matching placebo at weeks 6 and 12. arm 9: Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2 and 6, and matching placebo at week 12. arm 10: Participants received subcutaneous injections of 210 mg romosozumab on day 1 and weeks 2, 6, and 12.
Interventions: intervention 1: Romosozumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01081678
Conditions: Fracture Healing
Keywords: AMG 785 Proximal Femur Fracture Healing Hip Fracture
Sponsor: Amgen
Start date: 2010-06-20; Completion date: 2013-05-10
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an international, multi-center study to determine the efficacy, safety, and tolerability of romosozumab (AMG 785) in adults with a fresh unilateral hip fracture, status post surgical fixation.

Detailed description:

Arms: arm 1: Participants received placebo to romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12. arm 2: Participants received 70 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12. arm 3: Participants received 140 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12. arm 4: Participants received 210 mg romosozumab administered by subcutaneous injection on day 1 and at weeks 2, 6, and 12.
Interventions: intervention 1: Placebo intervention 2: Romosozumab
Intervention descriptions: intervention 1: Administered by subcutaneous (under the skin) injection intervention 2: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01143246
Conditions: Hepatorenal Syndrome
Keywords: Hepatorenal syndrome Renal failure Cirrhosis Alcoholic hepatitis Ascites
Sponsor: Mallinckrodt
Start date: 2010-10-11; Completion date: 2013-05-10
Enrollment: 196 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to evaluate the efficacy and safety of intravenous terlipressin versus placebo for the treatment of type 1 hepatorenal syndrome (HRS) in participants receiving standard of care albumin therapy.

Detailed description:
Hepatorenal syndrome is a rare syndrome of marked renal dysfunction in patients with cirrhosis, decompensated liver disease, and portal hypertension. Hepatorenal syndrome type 1 is characterized by a rapid progressive renal impairment and has a very poor prognosis with \> 80% mortality within 3 months. At present, there are no approved drug therapies for HRS type 1 in the US, Australia, or Canada. The only curative treatment for HRS type 1 and the underlying end-stage cirrhosis is liver transplantation. However, many patients will not survive long enough to receive a liver transplant and therapy, which may provide a bridge to transplantation, is badly needed. Increased understanding of the pathophysiology of HRS type 1 has demonstrated that vasoconstrictive drug therapy may reverse HRS type 1. Substantial data available from many published clinical investigations in the literature provide compelling evidence suggesting that administration of terlipressin improves renal function in patients with HRS.

Arms: arm 1: Participants receive terlipressin intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol. arm 2: Participants receive matching placebo intravenously as a bolus injection, followed by a saline flush. Dose, duration, retreatment and/or discontinuation may be modified by the investigator, per protocol.
Interventions: intervention 1: Terlipressin intervention 2: Placebo
Intervention descriptions: intervention 1: Each 6 mL vial contains 1 mg lyophilized terlipressin acetate and 10 mg mannitol in sterile 0.9% sodium chloride solution. intervention 2: 11 mg mannitol reconstituted with 5 ml of sterile 0.9% sodium chloride solution.

Protocol documents:
Clinical trial NCT01326962
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2011-11-30; Completion date: 2013-05-12
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: 8 mg/kg (max. 800 mg) iv every 4 weeks, 6 infusions

Protocol documents: