ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01820364
Conditions: Melanoma
Keywords: open-label study BRAF inhibitor LGX818 MEK1620 MAPK1/2 inhibitor Pi3K inhibitor FGFR c-Met CDK4/6 metastatic melanoma BRAF V600
Sponsor: Array BioPharma
Start date: 2013-11-01; Completion date: 2015-03-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of the Phase II CLGX818X2102 study is to assess the anti-tumor activity of LGX818 in combination with selected agents.

Detailed description:
This is a phase II two part multi-center, open-label study. Part I: LGX818 single agent treatment until progression Part II: Combination treatments of LGX818 + MEK162, or BKM120, or BGJ398, or INC280, or LEE01 to assess the clinical efficacy, to further evaluate the safety of the drug combinations in patients with locally advanced or metastatic BRAF mutant melanoma after relapse on LGX818, and to determine the maximum tolerated dose of the combinations (when not established previously). These drug combinations are selected and assigned to patients based on documentation of molecular resistance mechanism.

Patients with BRAF mutant melanoma treated by LGX818 single agent in other studies can be enrolled directly in Part II of CLGX818X2102 after relapse.

Dose-escalations in the combination arms for which no MTD has been established will be based on the recommendations of a Bayesian logistic regression model guided by an escalation with overdose control criterion.

After careful evaluation of slow enrollment and the BRAF-mutant melanoma treatment landscape, recruitment was permanently halted on 26-Jul-2014.

This recruitment halt was not a consequence of any safety concern and patients who were ongoing in the study continued to be treated as per protocol.

Arms: arm 1: Patients had to have written documentation of a BRAFV600 mutation, which was to have been obtained locally on a fresh tumor biopsy (preferred) or on the most recent archival tumor sample available.
Interventions: intervention 1: LGX818
Intervention descriptions: intervention 1: BRAF inhibitor. LGX818 was administered QD orally on a daily schedule (21-day cycles) as a flat-fixed dose and not by body weight or body surface area. LGX818 100 mg capsules and 50 mg capsules.

Protocol documents:
Clinical trial NCT01822132
Conditions: Methamphetamine Abuse HIV
Sponsor: Oregon Health and Science University
Start date: 2013-05-01; Completion date: 2015-03-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this protocol is to learn more about impulsive decision making in people who use methamphetamines. The investigators would like to know if a medication called naltrexone changes how people make decisions. The investigators would also like to know whether changes in decision making can be observed by MRI (magnetic resonance imaging).

The research is conducted in Portland, OR.

Detailed description:

Arms: arm 1: One dose of intramuscular injection of 380mg extended-release naltrexone. arm 2: One dose of intramuscular injection of placebo.
Interventions: intervention 1: Extended release naltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01822821
Conditions: Pain
Keywords: Males or females 18 years of age or older. Non-emergency cardiac surgery midline sternotomy.
Sponsor: The Cleveland Clinic
Start date: 2013-03-01; Completion date: 2015-03-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.

Detailed description:

Arms: arm 1: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids. arm 2: Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
Interventions: intervention 1: IV Acetaminophen intervention 2: Placebo
Intervention descriptions: intervention 1: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids. intervention 2: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.

Protocol documents:
Clinical trial NCT01834586
Conditions: Multiple Sclerosis
Sponsor: Brown, Theodore R., M.D., MPH
Start date: 2013-03-01; Completion date: 2015-03-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if applying an anesthetic topical adhesive, Synera®, will reduce the injection pain. Relieving injection site pain may improve the tolerability of Multiple Sclerosis medications.

Study Hypothesis: Pre-medication with Synera will have a significant effect on pain ratings as measured by the visual analog scale and Local injection site reaction scale.

Detailed description:
Open-label prospective study of Synera to reduce injection pain in 30 patients with relapsing forms of Multiple Sclerosis taking interferon beta or glatiramer acetate. The duration will be 3-6 weeks (1-2 weeks of baseline observation followed by 2-4 weeks of on-drug observation), depending on which Multiple Sclerosis drug product is being studied. The study will include down-titration from 60 to 30 minutes of application to assess for any difference in responses. We define one primary outcome measure,"pain upon injection" by visual analog scale (VAS). Secondary measures will include 24-hour ratings of pain by VAS and 24-hour local injection site reaction (LISR) scale score.

Arms: arm 1: Anesthetic Topical Adhesive Synera. For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.

For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week.
Interventions: intervention 1: Anesthetic Topical Adhesive Synera
Intervention descriptions: intervention 1: For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.

For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week

Protocol documents:
Clinical trial NCT01836458
Conditions: Malaria
Keywords: Malaria, KAE609
Sponsor: Novartis Pharmaceuticals
Start date: 2014-01-01; Completion date: 2015-03-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609

Detailed description:
There will be a total of approximately 45 patients recruited into this study and six doses of KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a single dose of KAE609 and be followed up for 42 days.

Arms: arm 1: Single dose of KAE609 30 mg arm 2: Single dose of KAE609 20 mg arm 3: Single dose of KAE609 10 mg arm 4: Single dose of KAE609 15 mg
Interventions: intervention 1: KAE609
Intervention descriptions: intervention 1: Patients will receive KAE609 single dose at a different dose level in each cohort.

Protocol documents:
Clinical trial NCT01843842
Conditions: Acute Upper Respiratory Tract Infections
Sponsor: Materia Medica Holding
Start date: 2013-04-01; Completion date: 2015-03-01
Enrollment: 306 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is:

* to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children;
* to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.

Detailed description:
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ergoferon intervention 2: Placebo
Intervention descriptions: intervention 1: Safety and Efficiency of liquid dosage form intervention 2: Safety and Efficiency of liquid dosage form

Protocol documents:
Clinical trial NCT01854658
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Pearl Therapeutics, Inc.
Start date: 2013-07-01; Completion date: 2015-03-01
Enrollment: 1615 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.

Detailed description:

Arms: arm 1: FF MDI administered as two puffs BID arm 2: GP MDI administered as two puffs BID arm 3: GFF MDI administered as two puffs BID arm 4: Inhaled placebo administered as two puffs BID
Interventions: intervention 1: GFF MDI (PT003) intervention 2: GP MDI (PT001) intervention 3: FF MDI (PT005) intervention 4: Placebo
Intervention descriptions: intervention 1: GFF MDI administered as two puffs BID intervention 2: GP MDI administered as two puffs BID intervention 3: FF MDI administered as two puffs BID intervention 4: None

Protocol documents:
Clinical trial NCT01861301
Conditions: Epithelioid Mesothelioma Recurrent Malignant Mesothelioma Sarcomatoid Mesothelioma Stage II Pleural Mesothelioma Stage III Pleural Mesothelioma Stage IV Pleural Mesothelioma
Sponsor: National Cancer Institute (NCI)
Start date: 2013-01-01; Completion date: 2015-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well tivantinib works in treating patients with previously treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the objective response rate of patients with malignant mesothelioma who are treated with ARQ 197 (tivantinib).

SECONDARY OBJECTIVES:

I. To determine the progression-free survival of patients with malignant mesothelioma who are treated with ARQ 197.

II. To determine the toxicity experienced by patients with malignant mesothelioma who are treated with ARQ 197.

III. To determine median and overall survival of patients with malignant mesothelioma who are treated with ARQ 197.

TERTIARY OBJECTIVES:

I. To determine the frequency of mesenchymal-epithelial transition (MET) gene amplification in malignant mesothelioma patient tumor samples, and to correlate the results with MET immunohistochemistry (IHC).

II. To determine whether MET gene amplification results in increased sensitivity to ARQ 197 as observed by improved clinical outcomes (response rate \[RR\] and progression free survival \[PFS\]) compared to those without MET gene over-expression/amplification.

III. To determine whether high baseline serum hepatocyte growth factor (HGF), as well as changes in serum HGF during treatment at pre-defined early time points, correlate with treatment efficacy and clinical outcome, as measured by response rate and progression-free survival.

IV. To identify mutations by sequencing of specific areas of the MET gene in tumor samples (semaphorin \[SEMA\], jumonji \[JM\] and tyrosine kinase domains).

V. To perform immunohistochemistry (IHC) of mesothelioma tumors for HGF, MET and phosphorylated (p)-MET (pY1003 and pY1230/34/35).

VI. To assess serum HGF and serum soluble MET levels by enzyme linked immunosorbent assay (ELISA) (R\&D systems) pre-treatment, after 2 cycles and at disease progression.

OUTLINE:

Patients receive tivantinib orally (PO) twice daily (BID). Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 1 year.

Arms: arm 1: Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: Laboratory Biomarker Analysis intervention 2: Tivantinib
Intervention descriptions: intervention 1: Correlative studies intervention 2: Given PO

Protocol documents:
Clinical trial NCT01884675
Conditions: Hypertension
Keywords: Endothelin Receptor Antagonist Inoperable Chronic Thromboembolic Pulmonary Hypertension
Sponsor: GlaxoSmithKline
Start date: 2013-09-01; Completion date: 2015-03-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is hypothesised that ambrisentan may provide benefit to subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH), where currently no proven or licensed treatment options exist. This Phase III, randomized, double-blind placebo controlled parallel group, 16 week study will compare the safety and efficacy of ambrisentan 5 milligrams (mg) versus placebo in subjects with inoperable CTEPH. The study will enrol 160 subjects, to assure at least 72 evaluable subjects per treatment arm, based on 10% drop-out rate.

Detailed description:

Arms: arm 1: Subjects in this arm will receive ambrisentan 5 mg tablet once daily during the treatment period. arm 2: Subjects in this arm will receive ambrisentan-matching placebo tablet once daily during the treatment period.
Interventions: intervention 1: Ambrisentan 5 mg intervention 2: Placebo
Intervention descriptions: intervention 1: White, film-coated, immediate-release tablets, containing 5 mg ambrisentan for single dose oral. intervention 2: White, film-coated, ambrisentan-matching placebo tablet for single oral dose

Protocol documents:
Clinical trial NCT01891864
Conditions: Chronic Stable Plaque Psoriasis
Sponsor: Sandoz
Start date: 2013-06-01; Completion date: 2015-03-01
Enrollment: 531 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to demonstrate equivalent efficacy of GP2015 and Enbrel® in patients with moderate to severe chronic plaque-type psoriasis with respect to PASI 75 response rate at Week 12.

Detailed description:
The purpose of this confirmatory safety and efficacy study (GP15-302) was to demonstrate equivalence in efficacy and similarity in safety and immunogenicity of GP2015 and Enbrel (EU-authorized) in patients with moderate to severe chronic plaque-type psoriasis and to evaluate the effects of repeated switching between GP2015 and Enbrel on efficacy, overall safety, and immunogenicity. Since only EU-authorized Enbrel was utilized in this study, the use of the term "Enbrel" throughout this report describes EU-authorized Enbrel only.

Arms: arm 1: Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter arm 2: Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter
Interventions: intervention 1: GP2015 Etanercept intervention 2: Enbrel
Intervention descriptions: intervention 1: Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel. intervention 2: Enbrel is used as reference product to GP2015.

Protocol documents:
Clinical trial NCT01895101
Conditions: Blood Loss Tranexamic Acid Cardiac Surgery
Keywords: blood loss tranexamix acid cardiac surgery
Sponsor: Amphia Hospital
Start date: 2013-10-01; Completion date: 2015-03-01
Enrollment: 750 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It remains still unclear whether topical tranexamic acid has an added value besides the administration of intravenously tranexamic acid. We hypothesize that the addition of topical tranexamic acid, besides intravenous administration of tranexamic acid, results in a 25% reduction of post-operative blood loss after cardiac surgery.

The aim of this study is to determine whether the application of topical tranexamic acid reduces the 12 hours postoperative blood loss by 25% in patient scheduled for cardiac surgery on cardiopulmonary bypass, whereby intravenous tranexamic acid is administrated.

Just before sternal closure, 250 subjects receives pericardial lavage with 2 gr tranexamic acid in 200 ml normothermic saline solution (NaCl 0.9%), 250 subjects receives pericardial lavage with 200 ml normothermic saline solution without TA and 250 subjects (control group) receives no pericardial lavage. The main study parameter is 12 hours post-operative blood loss and is assessed by 12 hours post-operative chest tube production.

Detailed description:

Arms: arm 1: According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid. arm 2: According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

In this arm the subjects receives as in standard care no pericardial lavage. arm 3: According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.

This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).
Interventions: intervention 1: 2 gr tranexamic acid intervention 2: Saline
Intervention descriptions: intervention 1: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%). intervention 2: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid

Protocol documents:
Clinical trial NCT01899326
Conditions: DS (Durie/Salmon) Stage I Plasma Cell Myeloma DS Stage II Plasma Cell Myeloma DS Stage III Plasma Cell Myeloma Refractory Plasma Cell Myeloma
Sponsor: Albert Einstein College of Medicine
Start date: 2013-09-01; Completion date: 2015-03-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This pilot clinical trial studied how well desipramine hydrochloride and filgrastim worked for stem cell mobilization in participants with multiple myeloma (MM) undergoing stem cell transplant. Giving colony-stimulating factors, such as filgrastim, and other drugs, such as desipramine hydrochloride, helps stem cells move from the participant's bone marrow to the blood so they can be collected and stored.

Detailed description:
PRIMARY OBJECTIVES:

I. To study efficacy, safety, harvest kinetics and engraftment kinetics of participants undergoing autologous stem cell mobilization, mobilized with a combination of granulocyte colony-stimulating factor (GCSF) (filgrastim) with desipramine (desipramine hydrochloride) (G+D).

II. To analyze polymorphisms of adrenergic receptor beta 2 (ADRB2) and adrenergic receptor beta 3 (ADRB3) genes that correlate with mobilization efficiency.

OUTLINE:

Participants received desipramine hydrochloride orally (PO) daily on days -3 to +4 and filgrastim PO twice daily (BID) on days 1-4. Stem cell collection began on day 6.

After completion of study treatment, participants were followed up to 1 week after completion of stem cell collection.

Arms: arm 1: Participants received desipramine hydrochloride PO daily on days -3 to +4 and filgrastim PO BID on days 1-4. Stem cell collection began on day 6.
Interventions: intervention 1: Desipramine Hydrochloride intervention 2: Filgrastim intervention 3: Laboratory Biomarker Analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Correlative studies

Protocol documents:
Clinical trial NCT01901276
Conditions: Clostridium Difficile
Keywords: Proton Pump Inhibitors Microbiome Clostridium difficile
Sponsor: Daniel Freedberg, MD
Start date: 2013-08-01; Completion date: 2015-03-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The colonic microbiome is essential in human health and disease. Clostridium difficile-associated diarrhea (CDAD), a highly morbid form of infectious diarrhea, is caused by antibiotics which perturb the microbiome and allow C. difficile to proliferate. Proton pump inhibitors (PPIs) are powerful suppressors of gastric acid and among the most common medicines in the United States. Dozens of observational studies show that longterm PPI use is associated with CDAD. However, the mechanism by which PPIs cause CDAD is unknown. We believe that PPIs cause CDAD by inducing alterations in the human colonic microbiome. We will confirm or refute the hypothesized mechanism for the association between PPIs and CDAD using an unblinded, single-armed study design. We will use pyrosequencing of the hypervariable V4 region of the bacterial 16S ribosomal subunit gene in human fecal samples to describe the colonic flora. We will collect fecal samples from volunteers before and after PPIs given for different durations and test the microbiome to determine 1) whether PPIs diminish overall diversity, 2) whether PPIs diminish relative abundance of Bacteroidetes, 3) whether increased duration of PPIs affects diversity, and 4) whether there is recovery of diversity after completing a defined course of PPIs. We believe that PPIs will cause a pattern of diminished overall microbiome diversity and reduced anaerobes - the same pattern seen after use of antibiotics. Furthermore, we believe that increased PPI duration will further diminish diversity and that the microbiome will return to pre-PPI levels of diversity after PPIs are stopped. These results will facilitate biologically-based clinical interventions to reduce rates of CDAD among patients who require acid suppression.

Detailed description:
Study Design We will recruit 12 adult volunteers for a crossover study with a total duration of 12 weeks. Subjects will be observed off of PPIs for 4 weeks and then will be placed on PPIs for 4 weeks. Subsequently, subjects will be randomized to receive an additional 4 weeks of PPIs or no therapy. Stool samples will be collected at 4 separate time points.

Study Outcomes and Statistical Analyses The primary outcome will be change in overall diversity of fecal flora after 4 weeks of PPIs compared to 4 weeks of no acid suppression. Additional outcomes to be assessed include the effect of PPIs on the relative abundance of Bacteroidetes at week 4 and change in the diversity of fecal flora at week 8.

Arms: arm 1: See study description for further details.
Interventions: intervention 1: Omeprazole 40 mg bid
Intervention descriptions: intervention 1: As above.

Protocol documents: