ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02164318
Conditions: End Stage Renal Disease
Sponsor: Duke University
Start date: 2014-09-01; Completion date: 2017-03-10
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a program of forearm exercise training, application of nitroglycerin ointment or both. Goals of this study are (A) to measure if recruited subjects can tolerate the intervention protocols, and determine if dependent variable measures, including surgery outcome, and measurement of physiologic and biologic markers, can be obtained; (B) To measure subject compliance and adherence rates for each of the intervention arms and testing visits; (C) To examine which intervention or combination of interventions demonstrates the strongest preliminary effects in order to estimate power for a pivotal intent to treat trial; and (D) explore group differences in clinical vascular markers and biologic markers in vein tissue.

Detailed description:
This project will examine if enhancing Nitric Oxide (NO) bioavailability increases the rates of arteriovenous fistula (AVF) maturation in end stage renal disease patients requiring vascular access for hemodialysis. To enhance NO bioavailability the study team will utilize a program of forearm exercise training, application of nitroglycerin ointment or both.

Following entry into the study, approximately 4 weeks prior to surgery subjects will undergo a series of non-invasive tests of vascular function in the arm of fistula creation. Following this vascular function testing, subjects will follow the intervention treatment for 4 weeks. After 4 weeks of intervention treatment and prior to surgery, the vascular function analysis will be repeated to determine if the interventions had an effect on arm vascular function. Surgery to create the AVF will follow the second vascular function analysis. A discard sample of the vein used to create the AVF and a blood sample will be collected during surgery to assess potential biologic differences between intervention groups. The interventions will be continued until 4 weeks following surgery. Subjects will be followed to determine if the AVF matured and was successfully used for dialysis.

Arms: arm 1: Standard of care arm 2: Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes arm 3: Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly arm 4: Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly
Interventions: intervention 1: Handgrip training intervention 2: Nitroglycerin ointment
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00310375
Conditions: Epilepsy
Keywords: Epilepsy Partial Seizures Potassium Channels Anticonvulsant Complex Partial Seizures Epilepsies, Partial RTG115098
Sponsor: GlaxoSmithKline
Start date: 2006-05-01; Completion date: 2017-03-15
Enrollment: 181 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures, who completed the VRX-RET-E22-301 double-blind study. The efficacy of long-term treatment with retigabine and patient quality of life will also be assessed.

Detailed description:
This Phase 3 trial is an open-label extension study of the placebo-controlled, double-blind VRX-RET-E22-301 trial. Patients who have completed the VRX-RET-E22-301 trial and who meet inclusion and exclusion criteria will be treated with 600-1200 mg/day of retigabine as an adjunct therapy to their current antiepileptic drugs (AEDs) or vagal nerve stimulation. Treatment will be continued until retigabine is commercially available, or until the program is discontinued. Patients will be recruited from 45-50 sites in the United States, Canada, Mexico, Brazil, and Argentina. The safety and tolerability of long-term therapy with retigabine administered as adjunctive therapy in adult epilepsy patients with partial-onset seizures will be evaluated. In addition, the efficacy of long-term treatment with retigabine and patient quality of life will be assessed.

Arms: arm 1: Film-coated tablets - 50mg, 100mg or 300mg
Interventions: intervention 1: Ezogabine: USAN Retigabine (International Nonproprietary Name)
Intervention descriptions: intervention 1: Film-coated tablets containing 50 mg, 100 mg, or 300 mg of retigabine per tablet. Dosage and frequency will be specific to each patient so long as the patient receives between 600 and 1200 mg of retigabine per day. The duration will be until the trial concludes or the patient leaves the trial.

Protocol documents:
Clinical trial NCT01393730
Conditions: Prostate Cancer
Keywords: prostate metastatic castrate resistant
Sponsor: Mary-Ellen Taplin, MD
Start date: 2011-09-01; Completion date: 2017-03-15
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine if the addition of dutasteride to a regimen with abiraterone acetate and prednisone will improve on therapy in patients with castrate-resistant prostate cancer and metastatic disease. This study will also help determine the side effects of the study treatment and how often they occur.

Detailed description:
Patients will receive abiraterone acetate and prednisone orally, once daily for 2 months (2 cycles) on an outpatient basis. At the start of cycle 3, dutasteride will be taken once daily. Patients will return to the clinic on Day 14 of the first 3 cycles for routine blood tests.

Patients will come to the clinic every 12 weeks for a CT scan and/or x-ray of the chest, CT scan or MRI of the abdomen and pelvis, bone scan, and blood test for testosterone and other specialized blood test.

Arms: arm 1: Abiraterone acetate 1000mg orally once per day + prednisone 5mg orally once per day for two months, followed by abiraterone 1000mg orally once per day + prednisone 5mg orally once per day + dutasteride 3.5mg orally once per day in 28-day cycles until symptomatic or radiographic progression
Interventions: intervention 1: Abiraterone acetate intervention 2: Dutasteride intervention 3: Prednisone
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01773109
Conditions: Metastatic Non Small Cell Lung Cancer Recurrent Non Small Cell Lung Cancer
Keywords: Male/female subjects 18 years of age and older metastatic or recurrent NSCLC who failed 2nd line therapy
Sponsor: Abramson Cancer Center at Penn Medicine
Start date: 2013-01-01; Completion date: 2017-03-15
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Phase 2 study is designed to characterize the objective response rate (defined as complete response (CR) and partial response (PR)) of Etirinotecan pegol administered to subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37 eligible subjects will receive the investigational drug q3 weeks until they are no longer benefiting.

Detailed description:
This is a Phase 2 study designed to characterize the objective response rate (defined as complete response (CR) and partial response (PR)) of Etirinotecan pegol (NKTR-102) administered to subjects with metastatic and recurrent NSCLC after failure of 2nd line therapy. Up to 37 eligible subjects will be enrolled at the University of Pennsylvania.

One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters and physical exam. Response will be determined by RECIST version1.1 after 2 cycles of therapy. Patients with stable disease (SD), PR or CR will continue on treatment for up to six cycles. Those who are benefitting after six cycles will have the option of continuing on treatment. Patients with progressive disease will be taken off study and will be followed for OS data.

Arms: arm 1: single-arm, open-label study is designed to investigate the efficacy and safety of etirinotecan pegol in patients with metastatic or recurrent NSCLC after failure of 2nd line therapy. Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Patients will be followed clinically every week for the first cycle with laboratory parameters (section 6.2.1) and physical exam. Response will be determined with RECIST version 1.1 after 2 cycles of therapy. Patients with Stable disease (SD), partial response (PR) or complete response (CR) will continue on additional therapy for up to six cycles. In the absence of disease progression in subjects completing six full cycles, further treatment beyond cycle #6 will be left to the discretion of the treating physician and his/her staff. Patients with progressive disease will be taken off study and will be followed for OS
Interventions: intervention 1: Etirinotecan pegol (NKTR-102)
Intervention descriptions: intervention 1: Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Treatment will be administered on an outpatient basis.

Protocol documents:
Clinical trial NCT00949650
Conditions: Carcinoma, Non-Small-Cell Lung Adenocarcinoma
Sponsor: Boehringer Ingelheim
Start date: 2009-08-14; Completion date: 2017-03-16
Enrollment: 345 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomised, open label phase III trial will be performed in patients with adenocarcinoma of the lung with tumours harbouring an Epidermal Growth Factor Receptor activating mutation. The objectives of the trial are to compare the efficacy of single agent BIBW 2992, Arm A, with Pemetrexed/Cisplatin chemotherapy, Arm B, as first line treatment for this group of patients.

Detailed description:

Arms: arm 1: BIBW 2992 tablet once daily until progression arm 2: Cisplatin and Pemetrexed IV once every 3 weeks for up to 6 cycles
Interventions: intervention 1: Pemetrexed intervention 2: BIBW 2992 intervention 3: Cisplatin
Intervention descriptions: intervention 1: Pemetrexed IV given once every 3 weeks for up to 6 cycles intervention 2: BIBW 2992 once daily until progression intervention 3: Cisplatin IV given once every 3 weeks for up to 6 cycles

Protocol documents:
Clinical trial NCT02641522
Conditions: Type 1 Diabetes
Keywords: T1D Type 1 diabetes
Sponsor: Carla Greenbaum, MD
Start date: 2016-03-08; Completion date: 2017-03-16
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effects of siltuximab on immune cell functions in patients with Type 1 diabetes (T1D).

Detailed description:
This is an open-label (all people know the identity of the intervention), single center, non-randomized (patients are not assigned by chance to treatment groups), Mechanistic Study (a study that focuses on the biologic activity of the drug, rather than on disease treatment). Up to 10 patients with Type 1 diabetes (T1D) will be enrolled in the study. Participants will receive a single dose of siltuximab and blood samples will be obtained a total of 6 times until 12 weeks after dosing. Cells will be isolated from the blood samples and used to measure specific activities of cells in the immune system. Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study. The end of study is the date of the last assessment for the last patient.

Arms: arm 1: Single infusion of siltuximab (11 mg/kg)
Interventions: intervention 1: Siltuximab
Intervention descriptions: intervention 1: Single infusion of siltuximab (11 mg/kg)

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT03140254
Conditions: Preoperative Skin Preparation
Sponsor: CareFusion
Start date: 2016-09-01; Completion date: 2017-03-17
Enrollment: 145 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and effectiveness of a topical antiseptic for preoperative skin preparation

Detailed description:

Arms: arm 1: Chlorhexidine gluconate arm 2: BDIP-0001 arm 3: Vehicle
Interventions: intervention 1: Chlorhexidine gluconate intervention 2: N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Prot_SAP_000.pdf:
Clinical trial NCT01392989
Conditions: Neural Tube Defects Anemia Leukemia, Myeloid Bone Marrow Transplant Failure Myelodysplastic Syndromes (MDS) Myeloproliferative Disorders
Sponsor: Everett Meyer
Start date: 2011-03-01; Completion date: 2017-03-19
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Allogeneic stem cell transplantation (transplant of blood cells from another individual) is a treatment option for patients with myelodysplasia or myeloproliferative Disorders. During the course of this study, it will be evaluated whether a particular type of blood cell, called a cytokine-induced killer (CIK) cell, may add benefit to allogeneic stem cell transplantation. CIK cells are present in small quantities in the bloodstream but their numbers can be expanded after a brief period of nurturing in a laboratory.

Detailed description:
Primary Objectives:

To determine the rate of conversion to FDC following infusion of allogeneic CIK cells among patients with MDS, therapy-related myeloid neoplasms, or MPD who receive non myeloablative preparative regimen of TLI / ATG followed by allogeneic HCT and consolidation with allogeneic CIK cells.

Secondary Objectives:

* To determine the 2 year overall survival (OS) and event free survival (EFS)
* To determine the incidence of acute GVHD following infusion of allogeneic CIK cells
* To assess the pre-transplant expression of NKG2D ligands in patients' bone marrow aspirates.

Arms: arm 1: Target dose of ≥ 5 x 10e6 CD34+ cells/kg of recipient body weight plus an additional 2 x10e9 mononuclear cells.
Interventions: intervention 1: CIK cells intervention 2: Cyclosporine intervention 3: Mycophenolate Mofetil intervention 4: Thymoglobulin intervention 5: Total Lymphoid Irradiation (TLI)
Intervention descriptions: intervention 1: Standard of care intervention 2: 5 mg/kg, po intervention 3: 15 mg/kg, oral intervention 4: 7.5 mg/kg, IV intervention 5: None

Protocol documents:
Clinical trial NCT02483585
Conditions: Migraine
Keywords: Migraine Headache Episodic Prevention Prophylaxis
Sponsor: Amgen
Start date: 2015-07-20; Completion date: 2017-03-20
Enrollment: 577 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.

Detailed description:
Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to \< 15 migraine days per month with \< 15 headache days per month will be randomized 1:1 to placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.

Arms: arm 1: Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase. arm 2: Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase.
Interventions: intervention 1: Erenumab intervention 2: Placebo
Intervention descriptions: intervention 1: Administered once a month by subcutaneous injection intervention 2: Administered once a month by subcutaneous injection

Protocol documents:
Clinical trial NCT01724177
Conditions: Adult T-Cell Leukemia-Lymphoma
Keywords: Lenalidomide ATL ATLL
Sponsor: Celgene
Start date: 2012-11-12; Completion date: 2017-03-21
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the efficacy of lenalidomide in patients with Adult T-cell Leukemia-lymphoma (ATL) who have previously received chemotherapy for ATL.

Detailed description:

Arms: arm 1: Lenalidomide 25mg by mouth (PO) daily until progressive disease or unacceptable toxicity
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: 25 mg of Lenalidomide administered orally once daily

Protocol documents:
Clinical trial NCT01703208
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-10-05; Completion date: 2017-03-22
Enrollment: 4202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the cardiovascular (CV) safety profile of omarigliptin in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that treatment with omarigliptin 25 mg once weekly is non-inferior to treatment with placebo and active comparators across the omarigliptin program with regard to the risk of developing a confirmed event in the primary CV composite endpoint.

Detailed description:
The trial was amended to extend the length of the trial in order to meet FDA requirements for the post-approval assessment of cardiovascular (CV) safety. The trial now contains 2 time intervals: Period 1 and Period 2. Period 1 refers to the time interval up to this recent protocol amendment and Period 2, the time interval from this protocol amendment until the end of the study. Participants in Period 1 will be re-consented and continue into Period 2. If required, additional participants will be enrolled in Period 2. Stage 1 refers to the prefiling United States Food and Drug Administration (US FDA) requirement to rule out a 80% increased CV risk. Stage 2 refers to the US FDA post-marketing requirement to rule out a 30% increased CV risk. The Stage 1 assessment of CV risk occurred during Period 1 and was based on a meta-analysis of major adverse CV events (MACE) and unstable angina across the omarigliptin Phase 2/Phase 3 program. The Stage 2 assessment will be based on MACE in P018 alone including CV events from both Period 1 and Period 2.

Arms: arm 1: Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly arm 2: Matching placebo to omarigliptin capsule or tablet administered orally once weekly
Interventions: intervention 1: Omarigliptin intervention 2: Placebo
Intervention descriptions: intervention 1: Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly intervention 2: Matching placebo to omarigliptin capsule or tablet administered orally once weekly

Protocol documents:
Clinical trial NCT03200912
Conditions: ACTINIC KERATOSIS
Sponsor: Actavis Inc.
Start date: 2016-08-19; Completion date: 2017-03-22
Enrollment: 507 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.

Detailed description:
Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the Food and Drug Administration (FDA) in 2012 for the topical treatment of AKs on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). The FDA approved regimen for ingenol mebutate gel, 0.015% for the treatment of AKs on the face and scalp is once-daily application of one unit dose tube for three consecutive days applied to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm).

Arms: arm 1: Picato® (ingenol mebutate) gel, 0.15% (Leo Pharma Inc.) \[Reference Listed Drug (RLD)\] arm 2: Generic ingenol mebutate gel, 0.15% \[Test\] arm 3: Vehicle gel of the test product
Interventions: intervention 1: Ingenol Mebutate (Picato®) intervention 2: Generic Ingenol Mebutate intervention 3: Vehicle Foam
Intervention descriptions: intervention 1: Brand product intervention 2: Generic formulated to have the same therapeutic effect of the brand intervention 3: It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.

Protocol documents:
Prot_000.pdf: 
 
 
 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL 
GROUP COMPARISON STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF A 
GENERIC INGENOL MEBUTATE GEL, 0.015% AND PICATO® GEL, 0.015% IN SUBJECTS WITH 
ACTINIC KERATOSIS ON THE FACE OR SCALP 
 
 
 
NCT03200912 
 
 
 
 
Protocol dated: May 26, 2016 













































































































SAP_001.pdf: 
 
 
 
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL 
GROUP COMPARISON STUDY TO DETERMINE THE THERAPEUTIC EQUIVALENCE OF A 
GENERIC INGENOL MEBUTATE GEL, 0.015% AND PICATO® GEL, 0.015% IN SUBJECTS WITH 
ACTINIC KERATOSIS ON THE FACE OR SCALP 
 
 
 
NCT03200912 
 
 
 
 
SAP dated: November 26, 2016
Clinical trial NCT01939899
Conditions: Follicular Lymphoma
Keywords: MLN9708 Lymphoma IXAZOMIB
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2013-10-31; Completion date: 2017-03-23
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to evaluate the anti-tumor activity of oral Ixazomib as measured by overall response rate (ORR) in adult participants with relapsed and/or refractory follicular lymphoma (FL).

Detailed description:

Arms: arm 1: Ixazomib 4, 5.3 and 7 milligram (mg), orally, once on Days 1, 8 and 15 in a 28 day treatment cycle followed by a rest period of 13 days, for up to Cycle 29 or until disease progression or unacceptable toxicity at lead-in phase for participants with NHL. After completion of lead-in phase, participants will continue into Phase 2. Participants in Phase 2 will receive Ixazomib at RP2D dose, orally, once weekly on Days 1, 8 and 15 in a 28 day treatment cycle followed by a rest period of 13 days , for up to Cycle 29 or until disease progression or unacceptable toxicity in Phase 2 for participants with RRFL.
Interventions: intervention 1: IXAZOMIB
Intervention descriptions: intervention 1: Each 28-day treatment cycle will include oral administration of IXAZOMIB on Days 1, 8, and 15 followed by a rest period of 13 days.

Protocol documents: