ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01741012
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Sponsor: Wayne State University
Start date: 2013-01-01; Completion date: 2015-11-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.

Detailed description:
To gather safety information and adverse events on the use of Gardasil® in mild to moderate and minimally active or inactive SLE.

To gather information on SLE disease activity flares after vaccination with Gardasil®.

To gather information on the immunogenicity or development of protective anti HPV antibodies SLE after vaccination with Gardasil®.

Arms: arm 1: 0.5 ml single dose Gardasil vaccine given at three separate visits
Interventions: intervention 1: Gardasil
Intervention descriptions: intervention 1: 0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6

Protocol documents:
Clinical trial NCT01765543
Conditions: Malignant Melanoma, Neoplasms
Sponsor: Hoffmann-La Roche
Start date: 2013-07-01; Completion date: 2015-11-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, multi-center, three-period, one-sequence study will investigate the effect of rifampin on the PK of vemurafenib in participants with unresectable BRAFV600-mutation positive metastatic melanoma or other malignant tumor type that harbors a V600-activating mutation of BRAF without acceptable standard treatment options. Eligible participants will have the option to continue treatment with vemurafenib as part of an extension study GO28399 (NCT01739764).

Detailed description:

Arms: arm 1: There will be 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, will receive vemurafenib at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily will be administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
Interventions: intervention 1: Rifampin intervention 2: Vemurafenib
Intervention descriptions: intervention 1: Rifampin at a dose of 600 mg as capsules orally once daily will be administered from Days 8 through 23 (Periods B and C). intervention 2: Participants, after an overnight fast of at least 10 hours, will receive vemurafenib at a dose of 960 mg as film-coated tablets orally on Day 1 (Period A) and on Day 17 (Period C).

Protocol documents:
Clinical trial NCT01766440
Conditions: Plaque Psoriasis
Sponsor: Galderma R&D
Start date: 2013-03-01; Completion date: 2015-11-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine if the calcitriol absorption in pediatric subjects is comparable to that in adults and adolescents, with no significant impact on calcium/phosphorus metabolism.

Detailed description:

Arms: arm 1: Topical application every 12 hours for 14 consecutive days
Interventions: intervention 1: Calcitriol 3 mcg/g ointment
Intervention descriptions: intervention 1: Topical ointment; twice daily application

Protocol documents:
Clinical trial NCT01791894
Conditions: Basal Cell Carcinoma of the Skin Recurrent Skin Cancer
Sponsor: Stanford University
Start date: 2013-04-01; Completion date: 2015-11-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studies arsenic trioxide in treating patients with basal cell carcinoma. Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stop them from dividing

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether administration of arsenic trioxide (ATO) to patients with basal cell carcinoma is associated with a reduction in Gli messenger ribonucleic acid (mRNA) and protein levels in tumor biopsy samples, when compared to baseline levels.

SECONDARY OBJECTIVES:

I. To determine whether there is evidence of tumor size reduction of ATO against basal cell carcinoma in humans.

OUTLINE:

Patients receive arsenic trioxide intravenously (IV) over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: arsenic trioxide
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT01805297
Conditions: Vitreous Hemorrhage
Keywords: Proliferative Diabetic Retinopathy
Sponsor: University of Oklahoma
Start date: 2013-03-01; Completion date: 2015-11-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the ocular and systemic safety of intravitreal aflibercept injection in patients undergoing Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy.

Detailed description:
Patients who need Pars Plana Vitrectomy surgery, and agree to participate in this study will receive an injection of 2.0mg aflibercept 4 to 6 days before Vitrectomy surgery. Half of these patients will be randomized to receive another injection of 2.0mg aflibercept immediately after their surgery. Postoperative patient visits in this study will be at 1 day, and at weeks 1, 4, 16 and 24, and at any other times as deemed necessary by the Investigator.

Arms: arm 1: Preoperative 2.0mg intravitreal aflibercept and vitrectomy with intraoperative 2.0mg intravitreal aflibercept injection. arm 2: Preoperative 2.0mg intravitreal aflibercept and standard of care vitrectomy.
Interventions: intervention 1: Intravitreal Aflibercept Injection intervention 2: Standard Vitrectomy
Intervention descriptions: intervention 1: One time 2.0mg aflibercept injection, following pars plana vitrectomy. intervention 2: Surgical intervention

Protocol documents:
Clinical trial NCT01840410
Conditions: Choroidal Neovascularization (CNV)
Keywords: Vision Impairment Abnormal growth of blood vessels
Sponsor: Novartis Pharmaceuticals
Start date: 2013-09-01; Completion date: 2015-11-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

Detailed description:

Arms: arm 1: A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity. arm 2: Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
Interventions: intervention 1: Ranibizumab intervention 2: Sham control
Intervention descriptions: intervention 1: Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant. intervention 2: The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.

Protocol documents:
Clinical trial NCT01841762
Conditions: Pulmonary Arterial Hypertension
Keywords: PAH-SYMPACT Pulmonary Arterial Hypertension psychometric instrument
Sponsor: Actelion
Start date: 2013-04-01; Completion date: 2015-11-01
Enrollment: 284 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
SYMPHONY is prospective, multi-center, open-label, single-arm, Phase 3b psychometric validation study of the PAH-SYMPACT, a new quality of life questionnaire for patients with pulmonary arterial hypertension. Patients will be in the study for 5 1/2 months, 4 months of which they will receive macitentan, 10 mg, once daily.

The primary objectives are to demonstrate the final content validity of the PAH SYMPACT instrument, to demonstrate the psychometric characteristics of reliability and construct validity of the PAH-SYMPACT instrument, and to demonstrate the ability of the PAH SYMPACT instrument to detect change. The secondary objective is to assess the safety of macitentan in patients with pulmonary arterial hypertension. The exploratory objective is to explore the effects of macitentan on PAH symptoms and their impact (as measured by the PAH-SYMPACT) in patients with pulmonary arterial hypertension.

Detailed description:

Arms: arm 1: Macitentan tablet, dose of 10 mg, once daily
Interventions: intervention 1: Macitentan
Intervention descriptions: intervention 1: Macitentan tablet, dose of 10 mg, once daily

Protocol documents:
Clinical trial NCT01847313
Conditions: Diabetic Kidney Disease
Keywords: kidney diabetes glp-1
Sponsor: Karl Neff
Start date: 2013-04-01; Completion date: 2015-11-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Diabetic kidney disease (DKD) is a devastating complication of diabetes, that in it's worst form, can lead to early cardiovascular death or kidney failure. A group of medicines used to treat diabetes, glucagon-like-peptide-1 analogues (GLP-1), may be able to protect people with diabetes from DKD by reducing inflammation in the kidney. This study aims to test this theory by studying the effect of GLP-1 on kidney function in people with diabetes.

To understand how GLP-1 can affect inflammation, the investigators will give a GLP-1 treatment (Liraglutide) to people with DKD and monitor the effect on inflammation and kidney function using blood and urine tests. The investigators will compare these results to patients with DKD who do not receive GLP-1 treatment.

If GLP-1 proves to be effective in reducing inflammation and improving kidney function, then it could be developed as a viable new treatment for people with DKD, and may significantly reduce the disease burden, or the risk of DKD, in people with diabetes. This would be a major advance in the treatment of DKD.

Detailed description:
A randomised controlled trial for patients with microalbuminuria and type 2 diabetes. Treatment is 0.6mg of liraglutide and is compared to standard care. Treatment duration is 6 months.

Arms: arm 1: Liraglutide 0.6 mg daily arm 2: Standard diabetes care including renin angiotensin aldosterone system inhibitor or antagonist
Interventions: intervention 1: Liraglutide
Intervention descriptions: intervention 1: Daily administration of liraglutide for 6 months

Protocol documents:
Clinical trial NCT01853046
Conditions: Neoplasms
Keywords: Regorafenib pharmacokinetics safety severe renal impairment Solid tumors
Sponsor: Bayer
Start date: 2013-06-01; Completion date: 2015-11-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To characterize the pharmacokinetics and safety of regorafenib in cancer subjects with severe renal impairment when compared to the Control group (cancer subjects with normal or mildly impaired renal function)

Detailed description:

Arms: arm 1: Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days. arm 2: Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
Interventions: intervention 1: Regorafenib (Stivarga, BAY73-4506)
Intervention descriptions: intervention 1: Regorafenib 160 mg o.d. will be administered as a single dose on Day 1 of Stage 1 followed by multiple dosing in an intermittent administration schedule (3 week-on/1 week-off) over 2 cycles in Stage 2 (56 days, cycle defined as 28 days)

Protocol documents:
Clinical trial NCT01856790
Conditions: Type 1 Diabetes
Sponsor: Jennifer Sherr
Start date: 2013-02-01; Completion date: 2015-11-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
"Closed loop artificial pancreas" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.

Detailed description:
Open-label, crossover study comparing the peak post-prandial glucose levels and the incremental post-prandial glucose area under the curve (AUC) during closed loop (CL) control alone and during CL control with liraglutide in an inpatient research setting. Data generated during outpatient baseline evaluation and liraglutide dose titration phases of the study will be compared to assess the short-term efficacy of this agent during open-loop continuous subcutaneous insulin infusion (CSII) pump treatment.

Arms: arm 1: Each participant recruited into the study will undergo two inpatient closed loop admissions.

The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.

Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.

Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.
Interventions: intervention 1: ePID closed loop system intervention 2: liraglutide
Intervention descriptions: intervention 1: Insulin pump controlled by closed loop unit and algorithm intervention 2: Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist

Protocol documents:
Clinical trial NCT01887288
Conditions: Metastatic Breast Cancer
Sponsor: Western Regional Medical Center
Start date: 2013-04-01; Completion date: 2015-11-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the Growth Modulation Index (GMI) of the combination of metronomic capecitabine with oral digoxin in metastatic breast cancer

Detailed description:
In this phase II study, the Investigators will combine metronomic capecitabine with digoxin to treat metastatic breast cancer patients who have progressed on both anthracyclines and taxanes. We hypothesize that the combination of digoxin with metronomic capecitabine may lead to increased efficacy and duration of treatment without progression with decreased side effects than standard regimen.

Arms: arm 1: Capecitabine PO daily b.i.d., no breaks, starts at day 1 of the first cycle; Digoxin: once daily, starts at day -7 of the first cycle

(1 cycle - 4 weeks)
Interventions: intervention 1: Capecitabine intervention 2: Digoxin
Intervention descriptions: intervention 1: 650 mg/m\^2 PO b.i.d. intervention 2: 0.25 mg once daily

Protocol documents:
Clinical trial NCT01919996
Conditions: Pharyngitis Tonsillitis
Keywords: Ocular safety azithromycin pharyngitis tonsillitis
Sponsor: Pfizer
Start date: 2013-12-01; Completion date: 2015-11-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This Post-Authorization Safety Study (PASS) is intended to fulfill a regulatory post-marketing requirement to provide data regarding visual abilities in children taking azithromycin (immediate-release formulation) for acute pharyngitis/tonsillitis. The primary objective of the study is to examine the incidence of clinically significant worsening in any of the following ophthalmic exams: best corrected visual acuity (distance), color vision, Amsler grid testing, anterior segment biomicroscopy, and fundus examination, in a group of approximately 30 pediatric patients taking azithromycin oral solution for treatment of an authorized indication of use (pharyngitis/ tonsillitis).

Detailed description:
Study was terminated prematurely on October 16, 2015 following FDA decision to release Sponsor from post-marketing commitment. No safety and/or efficacy concerns identified.

Arms: arm 1: Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
Interventions: intervention 1: Azithromycin
Intervention descriptions: intervention 1: Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days

Protocol documents:
Clinical trial NCT01939002
Conditions: Relapsing Multiple Sclerosis
Keywords: flu-like symptoms
Sponsor: Biogen
Start date: 2013-11-01; Completion date: 2015-11-01
Enrollment: 251 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine the proportion of participants with relapsing multiple sclerosis who experience new and/or increased flu-like symptoms (FLS) after transitioning from nonpegylated IFN-β therapies to peginterferon beta-1a (BIIB017).

Secondary objectives are: to determine the severity and frequency (measured by flu-like symptom score \[FLS-S\]) of FLS in these participants; to determine the duration (measured in number of hours) of FLS in these participants; to determine the effect of BIIB017 on other participant-reported outcomes, including treatment satisfaction (measured with the Treatment Satisfaction Questionnaire for Medication \[TSQM\]) and disability status (measured with the Patient Determined Disease Steps \[PDDS\]) over a 56-week period; to determine whether interferon-related FLS result in missed days of work/daily activities (e.g., absenteeism); to assess the use of additional medications (in addition to current medications used to treat FLS) to relieve BIIB017-related FLS; to determine the incidence of adverse events throughout the study period; to characterize the immunogenicity profiles of participants switching from prior IFN-β therapy to BIIB017.

Detailed description:

Arms: arm 1: Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician. arm 2: Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administer non-pegylated IFN therapy, participants receive BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
Interventions: intervention 1: BIIB017 intervention 2: naproxen
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01987453
Conditions: HCV Infection
Keywords: genotype 1
Sponsor: Gilead Sciences
Start date: 2014-07-01; Completion date: 2015-11-01
Enrollment: 100 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA \< lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

Detailed description:

Arms: arm 1: Participants who failed a prior SOF+RBV ± pegylated interferon (Peg-IFN) regimen will receive LDV/SOF FDC plus RBV for 12 weeks. arm 2: Participants who failed a prior LDV/SOF ± RBV regimen will receive LDV/SOF FDC for 24 weeks. arm 3: Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen will receive LDV/SOF FDC plus RBV for 24 weeks.
Interventions: intervention 1: LDV/SOF intervention 2: RBV
Intervention descriptions: intervention 1: Tablet(s) administered orally once daily intervention 2: Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.

Protocol documents:
Clinical trial NCT02002650
Conditions: Post-ERCP Acute Pancreatitis
Keywords: Indomethacin, pancreatitis, ERCP
Sponsor: Air Force Military Medical University, China
Start date: 2013-12-01; Completion date: 2015-11-01
Enrollment: 2600 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.

Detailed description:

Arms: arm 1: Pre-ERCP rectal Indomethacin in all patients. arm 2: Post-ERCP rectal Indomethacin in high-risk patients.
Interventions: intervention 1: Pre-ERCP rectal Indomethacin intervention 2: Post-operational Rectal Indomethacin
Intervention descriptions: intervention 1: Rectal Indomethacin was administrated within 30min before ERCP in all patients. intervention 2: Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.

Protocol documents: