ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01374971
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Cimzia Certolizumab Pegol Arthroscopic Synovial biopsy Office Based Procedure Biologic Tumor Necrosis Factor (TNF) Anti-TNF
Sponsor: Nathan Wei, MD, FACP, FACR:
Start date: 2011-09-01; Completion date: 2012-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to conduct an Investigator-Sponsored Study to determine the potential immunomodulatory effects of Certolizumab Pegol (CZP) treatment at the site of disease activity (synovial lining) in subjects with rheumatoid arthritis (RA), using pre treatment and post treatment arthroscopic synovial biopsies and ex vivo on gene expression.

Detailed description:

Arms: arm 1: Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks with arthroscopic synovial tissue biopsy pre- and post-treatment.
Interventions: intervention 1: Certolizumab Pegol (CZP) intervention 2: Arthroscopic synovial tissue biopsy
Intervention descriptions: intervention 1: CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks. intervention 2: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver.

Protocol documents:
Clinical trial NCT01388361
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-09-01; Completion date: 2012-07-01
Enrollment: 413 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and North America. The aim of this trial is to compare the efficacy and safety of adding liraglutide versus addition of insulin aspart with the largest meal to insulin degludec in subjects with type 2 diabetes.

Eligible subjects with an HbA1c equal to or above 7% at end of treatment in NN1250-3643 (NCT01193309) trial will be randomised to receive treatment intensification while subjects with an HbA1c below 7% at end of treatment in NN1250-3643 (NCT01193309) may continue to receive insulin degludec treatment. Subjects are to continue their pre-trial metformin treatment.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: insulin degludec intervention 2: insulin aspart intervention 3: liraglutide
Intervention descriptions: intervention 1: Injected s.c. (under the skin) once daily. The doses will be individually adjusted intervention 2: Injected s.c. (under the skin) once daily. The doses will be individually adjusted. intervention 3: Injected s.c. (under the skin) once daily. The doses will be individually adjusted.

Protocol documents:
Clinical trial NCT01398839
Conditions: Ectasia
Sponsor: Topcon Medical Systems, Inc.
Start date: 2010-12-01; Completion date: 2012-07-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: VEGA UV-A Illumination System intervention 2: Riboflavin
Intervention descriptions: intervention 1: Only subjects assigned to the treatment group will receive treatment with the UV Light intervention 2: Both treatment and sham groups will receive riboflavin

Protocol documents:
Clinical trial NCT01398852
Conditions: Keratoconus and Ectasia
Sponsor: Topcon Medical Systems, Inc.
Start date: 2010-12-01; Completion date: 2012-07-01
Enrollment: 500 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

Detailed description:

Arms: arm 1: All eyes to be treated with riboflavin and UV light
Interventions: intervention 1: Riboflavin intervention 2: VEGA UV-A Illumination System
Intervention descriptions: intervention 1: Riboflavin is a solution that will be delivered to the treatment area intervention 2: This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area

Protocol documents:
Clinical trial NCT01400425
Conditions: Progressive Cognitive Decline
Sponsor: Avid Radiopharmaceuticals
Start date: 2011-07-01; Completion date: 2012-07-01
Enrollment: 239 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is designed to evaluate whether a florbetapir F 18 PET scan can impact clinical thinking when physicians are determining the likely cause of a subject's cognitive impairment.

Detailed description:

Arms: arm 1: Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan.
Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: IV injection, 370 megabecquerel (MBq) (10 millicurie \[mCi\]), single dose

Protocol documents:
Clinical trial NCT01404429
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis Active
Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh
Start date: 2011-05-01; Completion date: 2012-07-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2 weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy) versus the adverse effects.

Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Methotrexate
Intervention descriptions: intervention 1: Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed

Protocol documents:
Clinical trial NCT01406860
Conditions: Primary Headaches (Includes Migraines, Tension, Cluster Headaches)
Keywords: Headaches Migraines Tension headaches Cluster headaches
Sponsor: University of Iowa
Start date: 2011-07-01; Completion date: 2012-07-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if droperidol is equally as effective as metoclopramide for treatment of primary headaches in the Emergency Department.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Droperidol intervention 2: Metoclopramide + diphenhydramine
Intervention descriptions: intervention 1: Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes intervention 2: Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.

Protocol documents:
Clinical trial NCT01427907
Conditions: Chronic Kidney Disease
Keywords: Serum phosphorus levels
Sponsor: Fresenius Medical Care North America
Start date: 2011-09-01; Completion date: 2012-07-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to demonstrate equivalence of calcium acetate oral solution and sevelamer carbonate in maintaining serum phosphorus levels

This is a phase IV, multicenter, randomized, open-label, cross-over study to assess the equivalence of a liquid formulation of a calcium-based phosphate binder, COS, to sevelamer carbonate tablets, in hemodialysis dependent Chronic Kidney Disease subjects (CKD). The aim of the study is to maintain serum phosphorus level and establish equivalence between COS and sevelamer carbonate tablets.

Detailed description:
Total 40 subjects will be randomized for participation into the study The subjects are Hemo-dialysis Dependent Chronic Kidney Disease (CKD) Stage 5D patients who are able to give informed consent to the study, and taking the phosphate binder sevelamer carbonate tablets.

Arms: arm 1: The investigational compound is calcium acetate oral solution (COS) or Phoslyra. It is a pale, light greenish-yellow clear liquid with a characteristic black cherry odor and flavor for oral ingestion. Each 5 mL of COS contains 667 mg calcium acetate equal to 169 mg of elemental calcium. Each subject will follow their usual prescription.COS will be taken either prior to or during meals and snacks. arm 2: Sevelamer carbonate is an anion exchange resin that binds phosphate in the gastrointestinal tract and is a buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphatemia in End-Stage Renal Disease (ESRD) patients. Each film-coated tablet of sevelamer carbonate (trade name Renvela™) contains 800 mg of sevelamer carbonate on an anhydrous basis. Subjects will receive sevelamer tablets according to their prescription.
Interventions: intervention 1: Calcium acetate oral solution (COS) intervention 2: Sevelamer carbonate
Intervention descriptions: intervention 1: Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2). intervention 2: Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).

Protocol documents:
Clinical trial NCT01427920
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2011-09-01; Completion date: 2012-07-01
Enrollment: 348 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial was conducted in Asia, Europe and South America. The aim of this trial was to confirm efficacy of subject driven titration (individually adjusted) of biphasic insulin aspart 30 (BIAsp 30) twice daily in terms of glycaemic control assessed by change in glycosylated haemoglobin (HbA1c).

Detailed description:

Arms: arm 1: The subjects performed the titration of BIAsp 30 dose. arm 2: The investigator performed the titration of BIAsp 30 dose.
Interventions: intervention 1: biphasic insulin aspart 30
Intervention descriptions: intervention 1: Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.

Protocol documents:
Clinical trial NCT01431716
Conditions: Pulmonary Arterial Hypertension
Sponsor: Actelion
Start date: 2011-03-01; Completion date: 2012-07-01
Enrollment: 42 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is investigating the effect of switching from Flolan® to Epoprostenol for Injection (EFI/ACT-385781A) in pulmonary arterial hypertension patients currently treated with Flolan®. For this purpose patients being treated for at least 12 months with Flolan® will be switched from Flolan® to EFI/ACT-385781A and followed-up for 90 days. During these 90 days safety and tolerability of EFI/ACT-385781A will closely be monitored in all treated patients. This 90 follow-up will provide clinical evidence on the safety, tolerability, efficacy and treatment satisfaction of switching from Flolan® to EFI/ACT-385781A in patients with pulmonary arterial hypertension.

Detailed description:

Arms: arm 1: EFI/ACT-385781 administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump
Interventions: intervention 1: EFI/ACT-385781A
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01453140
Conditions: Graft Versus Host Disease
Sponsor: Hackensack Meridian Health
Start date: 2011-08-01; Completion date: 2012-07-01
Enrollment: 3 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In this study the investigators are proposing to treat patients with steroid-refractory Graft-versus-host Disease (GVHD) stabilization using IL-2 and azacitidine

Detailed description:
High-dose cyclophosphamide and sirolimus have been successfully used for the prevention of Graft-versus-host Disease (GVHD) and have shown to enhance the Tregs subpopulation. The addition of low dose IL-2 and a demethylating agent such as azacitidine will also be studied in an attempt to promote and stabilize the FoxP3 expression of Tregs.

Arms: arm 1: cyclophosphamide and sirolimus combo arm 2: Low dose IL-2 with Cytoxan + Sirolimus Patients in treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus. arm 3: Lowdose IL-2, Vidaza, cyclophosphamide (Cytoxan) \& Sirolimus Patients in treatment arm C will be receiving low-dose azacitidine (Vidaza).
Interventions: intervention 1: Cyclophosphamide and Sirolimus intervention 2: Low dose IL-2 with Cytoxan + Sirolimus intervention 3: Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus intervention 4: Cyclophosphamide and Sirolimus intervention 5: Low dose IL-2 with Cytoxan + Sirolimus intervention 6: Low dose IL-2, Vidaza, Cytoxan & Sirolimus
Intervention descriptions: intervention 1: On the first day of treatment, cyclophosphamide will be administered at a dose of 4g/m2 IV x 1 dose. Patients who are \>40% above ideal weight will be dosed based on adjusted weight and adjusted BSA.

One day after the administration of cyclophosphamide, patients will receive sirolimus 6 mg PO x 1 and on the following day will start sirolimus at a dose of 2 mg PO daily. intervention 2: Patients in treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus.

IL-2 will be administered at a dose of 0.5E6 IU/m2 SQ daily x 8 weeks followed by 4 weeks off, starting 14 days after the cyclophosphamide. intervention 3: Patients in treatment arm C will be receiving low-dose azacitidine (Vidaza). The Vidaza will be initiated between day 27 and 32 following the cyclophosphamide.

The dose administered will be 10 mg SQ daily for 5 days followed by 3 weeks off. intervention 4: Day 1: Cyclophosphamide Day 2: Sirolimus intervention 5: treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus intervention 6: Vidaza will be initiated between day 27 and 32 following the cyclophosphamide.

Protocol documents:
Clinical trial NCT01458587
Conditions: Keratosis, Actinic
Keywords: Actinic keratosis
Sponsor: DUSA Pharmaceuticals, Inc.
Start date: 2011-11-01; Completion date: 2012-07-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aminolevulinic Acid PDT (ALA) intervention 2: Vehicle PDT (VEH)
Intervention descriptions: intervention 1: 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light intervention 2: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

Protocol documents:
Clinical trial NCT01488877
Conditions: Type 2 Diabetic Nephropathy
Keywords: Type 2 diabetes mellitus. albuminuria.
Sponsor: Pfizer
Start date: 2012-01-01; Completion date: 2012-07-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of multiple doses of PF-03882845 in this population.

Detailed description:
This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.

Arms: arm 1: None arm 2: 25 mg once daily arm 3: Placebo once daily
Interventions: intervention 1: PF-03882845 intervention 2: PF-03882845 intervention 3: PF-03882845 intervention 4: Spironolactone intervention 5: placebo
Intervention descriptions: intervention 1: 3 mg tablet once daily intervention 2: up to 10 mg tablet once daily intervention 3: up to 30 mg once daily intervention 4: spironolactone 25 mg once daily intervention 5: placebo once daily

Protocol documents:
Clinical trial NCT01505491
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2011-12-01; Completion date: 2012-07-01
Enrollment: 193 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial will investigate the pharmacokinetics, safety and tolerability of BI 695501 and to establish pharmacokinetic equivalence of BI 695501 to adalimumab.

Detailed description:

Arms: arm 1: Subject to receive one subcutaneous (s.c.) injection from a prefilled syringe containing BI 695501 arm 2: Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab arm 3: Subject to receive one s.c. injection from a prefilled syringe containing 40mg adalimumab
Interventions: intervention 1: adalimumab intervention 2: BI695501 intervention 3: adalimumab
Intervention descriptions: intervention 1: 40mg adalimumab single s.c. injection intervention 2: BI 695501 single s.c injection intervention 3: 40mg adalimumab single s.c. injection

Protocol documents:
Clinical trial NCT01505894
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-01-01; Completion date: 2012-07-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this trial was to investigate safety and tolerability of multiple doses of BI 409306 in healthy young and elderly volunteers.

The secondary objective was to explore the pharmacokinetics and pharmacodynamics of multiple doses of BI 409306 in healthy young and elderly volunteers

Detailed description:

Arms: arm 1: Placebo - Young Subjects arm 2: Placebo - Elderly Subjects arm 3: 25 milligram (mg) of BI 409306 were administered in young subjects once daily (QD). arm 4: 25 mg of BI 409306 were administered in elderly subjects once daily (QD). arm 5: 50 mg of BI 409306 were administered in young subjects once daily (QD). arm 6: 50 mg of BI 409306 were administered in young subjects twice daily (BID). arm 7: 50 mg of BI 409306 were administered in elderly subjects once daily arm 8: 100 mg of BI 409306 were administered in young subjects once daily (QD). arm 9: 100 mg of BI 409306 were administered in elderly subjects once daily (QD).
Interventions: intervention 1: BI 409306 intervention 2: Placebo
Intervention descriptions: intervention 1: Film-coated tablet intervention 2: Film-coated tablet

Protocol documents:
Clinical trial NCT01507220
Conditions: Bowel Obstruction
Keywords: open colectomy
Sponsor: Pacira Pharmaceuticals, Inc
Start date: 2012-03-01; Completion date: 2012-07-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome extended-release injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL therefore possibly reducing total hospitalization costs.

Detailed description:
This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome extended-release injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate for postsurgical analgesia in adult patients undergoing open colectomy with general anesthesia.

Arms: arm 1: morphine sulfate (or Sponsor-approved equivalent) arm 2: EXPAREL (bupivacaine liposome extended-release injectable suspension)
Interventions: intervention 1: morphine sulfate intervention 2: bupivacaine liposome extended-release injectable suspension
Intervention descriptions: intervention 1: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to the floor if the stay in the PACU is less than 1 hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump. intervention 2: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.

All patients will be offered rescue analgesia, as needed.

Protocol documents: