ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01535937
Conditions: Cocaine Dependence
Sponsor: New York State Psychiatric Institute
Start date: 2012-02-01; Completion date: 2017-04-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This project will evaluate the effect of a single sub-anesthetic dose of ketamine on the time to first cocaine use and abstinence rates in 60 treatment-seeking cocaine-dependent individuals receiving mindfulness-based relapse prevention (MBRP) therapy, using a 5 week combined laboratory-inpatient and outpatient double-blind, randomized, controlled trial.

Detailed description:
he study will begin with an inpatient phase (phase 1) of 5 days, during which abstinence is achieved, followed by a 4 week outpatient phase (phase 2). A single infusion of ketamine or midazolam will occur on day 3 of Phase 1. In addition to measures of mindfulness and impulsivity, stress sensitivity tests are incorporated into the design in order to elucidate mechanisms of action. The study hypotheses are:

1. ketamine and MBRP will significantly increase the time to first use compared to placebo and MBRP in cocaine-dependent individuals.
2. ketamine and MBRP is significantly more likely to lead to abstinence from cocaine (no use over one week) as compared to placebo and MBRP.
3. ketamine and MBRP will significantly reduce subjective, endocrine, and physiological responses to stress (including cue exposure) as compared to placebo and MBRP.
4. ketamine and MBRP will significantly increase mindfulness, as assessed by the Five Facet Mindfulness Questionnaire (FFMQ), as compared to placebo and MBRP.

Arms: arm 1: 0.5 mg/kg of ketamine IV over 40 minutes arm 2: 0.025 mg/kg IV over 40 minutes
Interventions: intervention 1: Ketamine intervention 2: Midazolam
Intervention descriptions: intervention 1: 0.5 mg/kg IV over 40 minutes intervention 2: 0.025 mg/kg IV over 40 minutes

Protocol documents:
Clinical trial NCT01626352
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Diffuse Large B-Cell Lymphoma Ofatumumab Bendamustine
Sponsor: SCRI Development Innovations, LLC
Start date: 2012-10-01; Completion date: 2017-04-01
Enrollment: 22 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-arm, Phase II study designed to enroll and treat up to 64 patients. All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion bendamustine Days 1 and 2 of Cycles 1 through 6 and ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2 through 6.

Detailed description:
While R-CHOP has improved survival and is considered standard of care for patients with DLBCL, the toxicities associated with R-CHOP are substantial in the elderly population. This is one of several reasons the outcome of older patients is worse than the corresponding younger patients. Bendamustine is an alkylating agent which causes intra- and inter-strand cross-links between DNA bases. Ofatumumab is a fully human anti-CD 20 antibody well tolerated by elderly patients. Ofatumumab targets a novel epitope of the CD20 molecule on B cells and remains on the cell surface twice as long as rituximab. The combination of both agents allows for a potentially efficacious, less toxic regimen.

Arms: arm 1: All patients in this study will receive ofatumumab and bendamustine as an IV infusion for 6 cycles (a cycle is defined as 21 days in length). Patients will receive as an IV infusion of bendamustine Days 1 and 2 of Cycles 1-6, ofatumumab Days 1 and 8 during Cycle 1 only and on Day 1 of Cycles 2-6.
Interventions: intervention 1: Bendamustine intervention 2: Ofatumumab
Intervention descriptions: intervention 1: Patients will receive as an IV infusion bendamustine 90 mg/m\^2 Days 1 and 2 of Cycles 1 through 6. intervention 2: Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6

Protocol documents:
Clinical trial NCT01715233
Conditions: Metastatic Esophageal Cancer Gastroesophageal Cancer Gastric Cancer
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2012-12-01; Completion date: 2017-04-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR.

Detailed description:
To estimate and compare the response rates in patients treated with mDCF based on methylation status of CHFR. The overall response rates in the un-methylated and methylated patient groups will be reported with a exact 95% binomial confidence interval. A chi-square test will be used for comparison.

Arms: arm 1: Participants receive Modified Docetaxel 40mg/m2, Leucovorin 400mg/m2 and Fluorouracil 400mg/m2 on day 1, Fluorouracil 1000mg/m2 per day on days 1 and 2 and Cisplatin 40mg/m2 (or Carboplatin) on day 3 in Patients With Metastatic Esophageal, Gastroesophageal And Gastric Cancer.
Interventions: intervention 1: Docetaxel intervention 2: Leucovorin intervention 3: Fluorouracil intervention 4: Cisplatin
Intervention descriptions: intervention 1: Modified Docetaxel 40mg/m2 on Day 1 intervention 2: Leucovorin 400mg/m2 on Day 1 intervention 3: Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2 intervention 4: Cisplatin (or Carboplatin) 40mg/m2 on Day 3

Protocol documents:
Clinical trial NCT01934894
Conditions: Metastatic Breast Cancer With Intracranial Metastases
Keywords: HER2-positive breast cancer intracranial metastases lapatinib cabazitaxel
Sponsor: SCRI Development Innovations, LLC
Start date: 2014-05-01; Completion date: 2017-04-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial will combine two agents, cabazitaxel and lapatinib, to treat patients with metastatic breast cancer (MBC) which has metastasized to the brain. The first portion of the study will determine the optimal dose of the cabazitaxel/lapatinib combination to administer to patients. After determining the optimal dose, patients will continue treatment with cabazitaxel and lapatinib to assess response to treatment with these agents.

Detailed description:
This is an open-label, non-randomized, Phase II study with a lead-in safety cohort. Through the safety lead-in portion of this trial we will define the optimal dose of cabazitaxel when given in combination with lapatinib for patients with HER2-positive MBC and CNS metastases. The Phase II portion will further assess intracranial response rate in patients with HER2-positive MBC and CNS metastases. Toxicity and progression free survival (PFS) will be obtained and evaluated. The trial will be conducted at multiple study sites by SCRI Development Innovations.

Arms: arm 1: * Cabazitaxel 1-hour IV infusion on Day 1 of each 3 week cycle (dose to be determined)
* Lapatinib PO once daily (dose to be determined)

Treatment cycles will be repeated every 3 weeks.
Interventions: intervention 1: cabazitaxel intervention 2: lapatinib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02058251
Conditions: Alcohol Use Disorders
Keywords: Alcohol Oxytocin Stress reactivity
Sponsor: Medical University of South Carolina
Start date: 2014-02-01; Completion date: 2017-04-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
In comparison to the general population, military personnel and veterans are at increased risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder (PTSD). Despite promising developments in the past decade, the treatment of patients with SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al., 2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or systemic OT administration decreases activation of the amygdala in response to visual fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little attention has been focused on whether OT decreases SUD vulnerability after exposure to traumatic stress in preclinical or clinical studies. This clinical project will determine whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.

Detailed description:

Arms: arm 1: Each participant will self-administer a 40 IU dose of intranasal oxytocin. arm 2: Each participant will self-administer a 40 IU dose of intranasal saline.
Interventions: intervention 1: Oxytocin intervention 2: Placebo
Intervention descriptions: intervention 1: One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants. intervention 2: Each participant will self-administer a 40 IU dose of intranasal saline.

Protocol documents:
Clinical trial NCT02707757
Conditions: Anaemia Haemodialysis
Keywords: Haemodialysis Anaemia Iron Erythropoeitin stimulating agents
Sponsor: Imperial College Healthcare NHS Trust
Start date: 2015-07-01; Completion date: 2017-04-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o

Detailed description:

Arms: arm 1: Iron sucrose 200mg for 5 doses arm 2: Incremental increase in dose along following parameters: 1000-2000-3000-4000-6000-8000-12000
Interventions: intervention 1: Iron sucrose intervention 2: Erythopoietin stimulating agent
Intervention descriptions: intervention 1: 1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl intervention 2: Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria

Protocol documents:
Clinical trial NCT02821338
Conditions: Healthy
Keywords: Bioequivalence Lamotrigine Extended Release Generic Pharmacokinetic
Sponsor: Food and Drug Administration (FDA)
Start date: 2016-06-01; Completion date: 2017-04-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to determine bioequivalence between two different formulations of lamotrigine extended release tablets (one reference product and one generic product) in a healthy adult population, following a single oral dose under fed conditions.

Detailed description:
This is a single center, randomized, open-label, single dose, two treatment, four-period, two-sequence, fully replicated crossover design in the fed state.

The study will include two treatments:

* Treatment-A: One dose of Lamotrigine extended-release tablet (Test) administered in the morning after a 10-hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.
* Treatment-B: One dose of Lamictal XR extended-release tablet (Reference) administered in the morning after a 10 hour overnight fast and 30 minutes after the start of a high-fat, high-calorie breakfast.

A total of 30 healthy subjects will be dosed to ensure that at least 24 subjects will complete the 4-period replicate design. For each treatment period, subjects will be confined from the day prior to dosing until approximately 48 hours post-dose. Subjects will return to the clinical site for the remaining blood samples. There will be a minimum 14-day washout between doses.

Subject participation from the Screening Visit to the Follow-Up Visit will be approximately 71 days.

Arms: arm 1: The treatments will be administered according to a randomly assigned pre-generated sequence involving the randomized, four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand). arm 2: The treatments will be administered according to a randomly assigned pre-generated sequence involving the four-period, two sequence, fully replicate crossover design. Two study drugs involved are: Lamotrigine Extended Release (generic) and Lamictal XR (brand).
Interventions: intervention 1: Lamotrigine Extended Release
Intervention descriptions: intervention 1: Lamotrigine Extended Release (generic) and Lamictal XR (brand).

Protocol documents:
Clinical trial NCT02971800
Conditions: Ureteral Injury
Keywords: sodium fluorescein ureteral efflux laparoscopic hysterectomy
Sponsor: CHU de Quebec-Universite Laval
Start date: 2016-08-01; Completion date: 2017-04-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective is to describe the safety and efficacy of intravenous sodium fluorescein to visualize ureteral efflux during intraoperative cystoscopy after total laparoscopic hysterectomy. Secondary objective is to report on surgeon's satisfaction with the overall use of sodium fluorescein.

Detailed description:
Thirty patients (n=30) ongoing a total laparoscopic hysterectomy in a tertiary gynecological reference center will be included in this prospective descriptive study.Once hysterectomy is completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose will be injected before performing diagnostic cystoscopy. Time from injection to fluorescent visualization will be recorded as well as coloration density. Adverse events are collected in the operating room, in the recovery room, before patient's discharge and through a home survey.

Arms: arm 1: Once hysterectomy completed, a 10 % solution of sodium fluorescein at a 0,25 ml dose (25 mg) is injected before performing diagnostic cystoscopy for all patient.

Name: Fluorescite Injection 10%, contains sodium fluorescein (equivalent to fluorescein 10% w/v) Dosage : 25 mg Frequency: only once
Interventions: intervention 1: sodium fluorescein injection 10%
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01729845
Conditions: Previously Treated Myelodysplastic Syndrome Recurrent Adult Acute Myeloid Leukemia
Sponsor: Fred Hutchinson Cancer Center
Start date: 2012-12-20; Completion date: 2017-04-03
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies the side effects and best dose of decitabine followed by mitoxantrone hydrochloride, etoposide, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has returned after a period of improvement or does not respond to treatment. Drugs used in chemotherapy, such as mitoxantrone hydrochloride, etoposide, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Detailed description:
PRIMARY OBJECTIVES:

I. Estimate the maximum tolerated dose (MTD) of decitabine priming followed by sequential mitoxantrone hydrochloride/etoposide/cytarabine (MEC) chemotherapy in adults with relapsed/refractory acute myeloid leukemia (AML).

SECONDARY OBJECTIVES:

I. Determine, within the limits of a Phase 1/2 study, disease response and duration of remission.

II. Identify biomarkers (e.g., deoxyribonucleic acid \[DNA\] methylation and/or gene expression changes) associated with treatment responses.

OUTLINE: This is a phase I, dose-escalation study of decitabine followed by a phase II study.

Patients receive decitabine intravenously (IV) on days -9 to -5 (dose level 1), days -11 to -5 (dose level 2), or days -14 to -5 (dose level 3).

INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving complete response (CR) or CR with incomplete platelet count recovery (CRp) may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.

After completion of study treatment, patients are followed up every 3 months for up to 5 years.

Arms: arm 1: Patients receive decitabine IV on days -9 to -5 (dose level 1), days -11 to -5 (dose level 2), or days -14 to -5 (dose level 3).

INDUCTION THERAPY: Patients receive mitoxantrone hydrochloride IV on days 1-5, etoposide IV on days 1-5, and cytarabine IV on days 1-5. Patients achieving CR or CR with CRp may receive up to 2 courses of induction therapy and up to 2 courses of consolidation therapy.
Interventions: intervention 1: Cytarabine intervention 2: Decitabine intervention 3: Etoposide intervention 4: Laboratory Biomarker Analysis intervention 5: Mitoxantrone Hydrochloride
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Correlative studies intervention 5: Given IV

Protocol documents:
Clinical trial NCT02418754
Conditions: Neovascular Age-Related Macular Degeneration
Sponsor: Regeneron Pharmaceuticals
Start date: 2015-05-05; Completion date: 2017-04-03
Enrollment: 505 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.

The secondary objectives of the study were the following:

* To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12)
* To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI.
* To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD

Detailed description:

Arms: arm 1: Intravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52. arm 2: Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52. arm 3: IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52. arm 4: Intravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52. arm 5: IAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
Interventions: intervention 1: REGN2176-3 intervention 2: Intravitreal Aflibercept Injection (IAI)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02265237
Conditions: Hepatitis C Virus
Keywords: Compensated Cirrhosis Hepatitis C Hepatitis C Genotype 4 Chronic Hepatitis C
Sponsor: AbbVie
Start date: 2014-10-28; Completion date: 2017-04-07
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis is to assess the safety and to compare the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\], to a clinically relevant threshold \[based on SVR rates for HCV genotype 4-infected participants treated with pegylated interferon (pegIFN)/RBV\].

Detailed description:
This is a Phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of ombitasvir/paritaprevir/ritonavir coadministered with RBV for 12, 16, or 24 weeks in HCV genotype 4 (GT4)-infected participants with compensated cirrhosis who are either treatment-naïve or who had previously received only IFN/RBV treatment for HCV.

The study also enrolled HCV GT4-infected participants with compensated cirrhosis who had previously experienced virologic failure with either SOF/pegIFN/RBV or sofosbuvir (SOF)/RBV treatment. These participants were treated with ombitasvir/paritaprevir/ritonavir coadministered with RBV for 24 weeks in this study.

This study was divided into 2 parts with approximately 184 total participants. Part I included participants who were randomized to receive either 12 or 16 weeks of treatment and Part II included participants who received 24 weeks of treatment. Enrollment into Part II opened once randomization in Part I was completed.

Arms: arm 1: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV. arm 2: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV. arm 3: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV. arm 4: Ombitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
Interventions: intervention 1: ombitasvir/paritaprevir/ritonavir intervention 2: ribavirin
Intervention descriptions: intervention 1: tablets intervention 2: tablets

Protocol documents: