ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01499355
Conditions: Lupus Nephritis
Sponsor: Biogen
Start date: 2012-07-01; Completion date: 2015-12-01
Enrollment: 276 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of participants with active, biopsy-proven lupus nephritis. The secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population.

Detailed description:
Participants who complete this study through Week 52 will be offered the option to enter an Extension study under a separate protocol 211LE202 (NCT0193089).

Arms: arm 1: Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and mycophenolate mofetil (MMF) arm 2: BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF. arm 3: BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
Interventions: intervention 1: BIIB023 intervention 2: Placebo intervention 3: mycophenolate mofetil intervention 4: oral corticosteroids
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: titrated to a target daily dose of 2 g (1 g twice daily) intervention 4: oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day

Protocol documents:
Clinical trial NCT01500135
Conditions: Bleeding
Keywords: Vascular Surgery Secondary treatment of needle hole bleeding Subjects undergoing vascular surgery and who need supportive treatment in order to control bleeding
Sponsor: Takeda
Start date: 2012-03-01; Completion date: 2015-12-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Present trial is the third study that in combination with two completed studies (one being a trial in hepatic resection surgery also comparing TachoSil® and Surgicel® Original) targeted toward providing clinical safety and efficacy data to support extending the current label of TachoSil® to a general hemostasis indication across several surgical procedures and organ systems in the USA.

Detailed description:
The drug being tested in this study is called TachoSil®. TachoSil® was used to treat people undergoing scheduled subacute vascular surgery. This study looked at how well TachoSil® patches stopped bleeding at the surgical site compared to Surgicel® Original patches.

The study enrolled 150 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two open label treatment groups in a 2:1 ratio:

* TachoSil®
* Surgicel® Original

This multi-center trial was conducted in the United States. The overall time to participate in this study was approximately 6 months. Participants made multiple visits to the clinic, including safety follow-up visits at 1, 3 and 6 months after surgery.

Arms: arm 1: TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated. arm 2: Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
Interventions: intervention 1: TachoSil® intervention 2: Surgicel® Original
Intervention descriptions: intervention 1: TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin. intervention 2: Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)

Protocol documents:
Clinical trial NCT01509404
Conditions: Cytomegalovirus Disease
Keywords: CMV cytomegalovirus transplant
Sponsor: Medical University of South Carolina
Start date: 2011-11-01; Completion date: 2015-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.

Detailed description:

Arms: arm 1: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant arm 2: valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant for prophylaxis against CMV infection
Interventions: intervention 1: Valganciclovir intervention 2: CMV hyperimmune globulin intervention 3: Valganciclovir
Intervention descriptions: intervention 1: Valcyte per package insert guidelines for 200 days post transplant intervention 2: 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant intervention 3: valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Protocol documents:
Clinical trial NCT01513902
Conditions: Juvenile Idiopathic Arthritis
Keywords: Arthritis Pediatric Tofacitinib JIA
Sponsor: Pfizer
Start date: 2013-03-01; Completion date: 2015-12-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).

Detailed description:
This is an open-label, non-randomized, multi-center, oral CP-690,550, multiple-dose (twice daily for 5 days \[except Day 5 when only morning dose will be given\]) study in pediatric subjects with JIA aged from 2 to less than 18 years. Baseline visit will occur within 1 month of the completion of the Screening Visit. The study will consist of three cohorts based on the age of the subjects, Cohort 3: 2 to less than 6 years, Cohort 2: 6 to less than 12 years and Cohort 1: 12 to less than 18 years. In each cohort, at least 8 pediatric subjects with JIA will participate in the study ensuring a total number of at least 24 pediatric evaluable subjects completing the PK period.

Arms: arm 1: Ages 12 to less than 18 arm 2: Ages 6 to less than 12 arm 3: Ages 2 to less than 6
Interventions: intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550
Intervention descriptions: intervention 1: CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing \<40 kg. Oral tablets will be used for children weighing ≥40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5 intervention 2: CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing \<40 kg. Oral tablets will be used for children weighing ≥40 kg. Children less than 12 years of age with a body weight of ≥40 kg will have the option of taking oral solution or tablets. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5 intervention 3: CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Children with a body weight ≥30 kg will have the option of taking oral solution or tablets, and children weighing \<30 kg will be dosed with the oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-6 1 1; 7-9 1.5 1.5; 10-12 2 2; 21-15 2.5 2.5; 16-19 3 3; 20-22 3.5 3.5; 23-26 4 4; 27-29 4.5 4.5; ≥30 5 5

Protocol documents:
Clinical trial NCT01524692
Conditions: Adenoid Cystic Carcinoma
Sponsor: University of Virginia
Start date: 2012-03-01; Completion date: 2015-12-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to improve survival of patients with recurrent or metastatic Adenoid Cystic Carcinoma (ACC). This study will test the efficacy of the investigational drug, TKI258, in treating ACC.

Detailed description:
Adenoid cystic carcinoma (ACC) is an uncommon malignancy that arises in secretory glands. The most common sites for the disease are the major and minor salivary glands but these tumors may also arise in the nasal cavity, lacrimal gland, tracheobronchial tree, breast or vulva. The mainstay of treatment for localized ACC is surgical resection often followed by post-operative radiotherapy. Although this leads to an initially high rate of local control, the 5-year disease-free survival rate is 50-75%. In addition, a significant proportion of the patients develop distant metastases, most frequently in the lung. Compared to other malignancies, ACC tends to grow more slowly. Thus, patients often do well in the short-term but long-term prognosis remains guarded and most succumb to the disease within 10-15 years. To date, systemic therapies have proven to be largely ineffective against recurrent and metastatic ACC. Dovitinib is a broad-targeted-profiled RTK inhibitor active against these three RTKs (VEGF, FGF and PDGF) involved in tumor cell growth. Based on its potency as an inhibitor of these RTKs both in vitro and in vivo, and the compound's oral availability, several clinical trials of dovitinib are underway. This phase II trial will test the hypothesis that dovitinib will be active against this disease. The rationale is based on pre-clinical studies that suggest that dovitinib suppresses tumor growth by blocking constitutive signaling of the fibroblast growth factor receptor-1 (FGFR1) and animal studies in which the drug proved to be active against primary ACC xenografts.

Arms: arm 1: Single ARM Dovitinib treatment
Interventions: intervention 1: Dovitinib (TKI258)
Intervention descriptions: intervention 1: 500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient.

Protocol documents:
Clinical trial NCT01540071
Conditions: Castration Resistant Prostate Cancer
Keywords: HRPC (Hormone refractory prostate cancer) Androgen independent prostate cancer CRPC (Castration and Taxane Resistant Prostate Cancer)
Sponsor: Io Therapeutics
Start date: 2011-08-01; Completion date: 2015-12-01
Enrollment: 38 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is to evaluate the benefits of investigational drug, NRX 194204 in slowing down/stopping/reversing progression of the castration resistant and taxane resistant prostate cancer.

Detailed description:
Numerous studies in pre-clinical models and in human clinical trials have clearly established the potential for the use of rexinoids in the treatment and prevention of cancer. NRX 194204, a second generation rexinoid, is a highly potent and specific activator of RXRs (retinoid X receptors). Because NRX 194204 is significantly more selective for the RXRs relative to the RARs (retinoic acid receptors) than a first generation approved drug, it is associated with fewer adverse events in clinical use. This study seeks to investigate NRX 194204 monotherapy in patients with castration- and taxane- resistant prostate cancer.

Arms: arm 1: This was a single arm open-label study. All patients enrolled received 20 mg of IRX4204 per day orally, for six months, or longer if the patient had disease stabilization and was tolerating the experimental treatment.
Interventions: intervention 1: NRX 194204
Intervention descriptions: intervention 1: NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day

Protocol documents:
Clinical trial NCT01553851
Conditions: Neoplasms, Oral Mouth Neoplasms
Sponsor: Washington University School of Medicine
Start date: 2013-02-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how trametinib effects tumor cells in patients with oral cavity squamous cell carcinoma that can be removed by surgery. Trametinib may shrink the tumor by blocking an enzyme pathway needed for cell growth.

Detailed description:
The rationale for this study in oral cavity squamous cell carcinomas rests on pre-clinical findings demonstrating that (a) activation of the ERK1/2 kinases is associated with aggressive features, (b) this aggressive phenotype is directly linked to expression of CD44, a cell surface hyaluronan receptor and (c) this association between activated ERK1/2 and CD44 is also identified in human cell lines and primary tumors. These data suggest that ERK1/2 is targetable biochemical pathway in CD44 expressing cells. These cells represent putative cancer stem cells or tumor initiating cells that have been associated with worse patient outcomes. Thus, the application of GSK1120212 to target OCSCC is a specific translational application of our laboratory findings.

Arms: arm 1: GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.
Interventions: intervention 1: GSK1120212
Intervention descriptions: intervention 1: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.

Protocol documents:
Clinical trial NCT01556009
Conditions: Basal Cell Nevus Syndrome Gorlin's Syndrome
Keywords: Basal Cell Carcinoma Photodynamic Therapy
Sponsor: UCSF Benioff Children's Hospital Oakland
Start date: 2012-04-01; Completion date: 2015-12-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate and compare the safety and efficacy of intermittent vismodegib and of Photodynamic Therapy (PDT).

Detailed description:
This is a Phase II, 28 month, randomized, two arm multicenter clinical study design. During the initial 7 months of the study, all 24 subjects will receive vismodegib, 150mg/day. They then will be randomized in a 1:1 ratio to receive intermittent vismodegib, 150 mg/day, during months 10-13, 16-19, and 22-25 or to receive treatment with PDT at month 10 and at three month intervals thereafter. The safety and efficacy of intermittent vismodegib and of PDT will be assessed at the time of the subjects' visits to the Study Center and at the time of telephone contacts. A Data Safety Monitoring Board (DSMB) will review results for an interim analysis when 12 subjects have completed 28 months. The DSMB review will focus on adverse events and efficacy results. Subjects will be monitored for the presence of surrogate endpoint biomarkers (SEBs) at each Study visit.

Arms: arm 1: Vismodegib taken orally 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months. arm 2: Aminolevulinic acid HCL 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.
Interventions: intervention 1: Vismodegib intervention 2: Aminolevulinic acid %20 topical solution
Intervention descriptions: intervention 1: 150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months. intervention 2: 20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.

Protocol documents:
Clinical trial NCT01556100
Conditions: Parkinson Disease
Keywords: 18F-DTBZ AV-133 imaging
Sponsor: Chang Gung Memorial Hospital
Start date: 2011-11-01; Completion date: 2015-12-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

Detailed description:
The primary objective of this protocol is to assess the rate of change in striatal 18F-DTBZ uptake in a cohort of Parkinson's disease patients.

This study is expected to be completed in a period of 4 years.

Arms: arm 1: 18F-DTBZ AV-133 imaging
Interventions: intervention 1: 18F-DTBZ AV-133
Intervention descriptions: intervention 1: A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.

Protocol documents:
Clinical trial NCT01581710
Conditions: Mild Persistent Asthma
Keywords: Leukotriene Antagonists Bronchodilator response
Sponsor: CHA University
Start date: 2012-05-01; Completion date: 2015-12-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study aims to identify markers to prove rapid improvement of lung function, airway inflammation and bronchodilator response after 2-week LTRA administration.

Detailed description:
This study is a randomized, double-blind, placebo-controlled, cross-over study with a washout period of at least one week between each study period.

After an initial screening visit, subjects entered a screening period of one to two weeks to ensure clinical stability without medication, which means absence of daily asthma symptoms. Eligible subjects were randomized into either the treatment portion of the trial, in which subjects received montelukast (4 mg or 5 mg) or matching placebo monotherapy in a randomized manner. During each treatment period, which lasted 2 weeks, the study medication was administered between 8:00 and 9:00 A.M. Short acting bronchodilator (for severe symptoms) was permitted during the study period but was withheld 24 hours prior to bronchodilator challenge test.

Inclusion criteria will be mild persistent asthma children old enough to cooperate on performing pulmonary function testing, children with no respiratory symptoms 4 weeks prior to the beginning of the study. Exclusion criteria will be the following: respiratory symptoms including cough, wheezing, dyspnea, or shortness of breath, presence of acute or chronic upper respiratory infections, anatomical nasal disorders (ex, nasal polyps, septum deviation, etc.), previous or current specific immunotherapy, use of systemic corticosteroids, or admission or visit of the emergency department during the previous 4 weeks.

Arms: arm 1: 14 days arm 2: 14 days arm 3: 14 days
Interventions: intervention 1: Montelukast to placebo intervention 2: Placebo to montelukast
Intervention descriptions: intervention 1: Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks intervention 2: Subjects will receive matching placebo. Each treatment period consists of 2 weeks

Protocol documents:
Clinical trial NCT01583179
Conditions: Regional Block for Pain Control Supraclavicular Block Ultrasound Guided Block Block Additive
Keywords: nerve block outpatient surgery
Sponsor: University of Wisconsin, Madison
Start date: 2012-04-01; Completion date: 2015-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The patients included will be those who have already agreed to have a brachial plexus nerve block for surgery. A flip of the coin will decide who gets and additive called buprenorphine in their block or not. They will both contain the same amount and type of numbing medicine. The goal will be to see if the additive extends the life of the pain control portion of the ultrasound guided supraclavicular nerve block.

Detailed description:

Arms: arm 1: will get only local anesthetic and epinephrine in block. no additive in block arm 2: will receive local anesthetic, epinephrine and the additive buprenorphine to nerve block
Interventions: intervention 1: Buprenorphine
Intervention descriptions: intervention 1: added to nerve block, 0.3mg one time peripheral block use

Protocol documents:
Clinical trial NCT01599832
Conditions: Clear Cell Renal Cell Carcinoma Recurrent Renal Cell Cancer Stage IV Renal Cell Cancer
Sponsor: University of Chicago
Start date: 2012-06-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out what effects pazopanib (pazopanib hydrochloride) (also called Votrient®) may have on MRI (magnetic resonance imaging) scans, blood pressure, and various proteins in the blood. Pazopanib is Food and Drug Administration (FDA) approved for treating renal cell cancer. It is an agent that prevents angiogenesis, which is new blood vessel formation. The use of pazopanib described in this study is a standard of care, but the additional MRI and blood tests that will be performed are experimental

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether a K\^trans rise from nadir is predictive of subsequent tumor growth.

SECONDARY OBJECTIVES:

I. To determine the association between changes in mean ambulatory blood pressure measurements, K\^trans, and tumor size changes with pazopanib therapy.

II. To determine the association between changes in soluble vascular endothelial growth factor receptor 2 (sVEGFR2) measurements, K\^trans, and tumor size changes with pazopanib therapy.

TERTIARY OBJECTIVES:

I. To explore previously described single nucleotide polymorphisms (SNP's) as pharmacogenomic biomarkers.

II. To model tumor growth kinetics using radiologic tumor size measurements. III. To explore other serum and plasma based putative biomarkers of vascular endothelial growth factor (VEGF) pathway inhibition.

OUTLINE:

Patients receive pazopanib hydrochloride orally (PO) once daily (QD) in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Arms: arm 1: Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.
Interventions: intervention 1: pazopanib hydrochloride intervention 2: laboratory biomarker analysis intervention 3: dynamic contrast-enhanced magnetic resonance imaging intervention 4: pharmacogenomic studies
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies intervention 3: Undergo dynamic contrast-enhanced magnetic resonance imaging intervention 4: Correlative studies

Protocol documents: