Clinical trials: Optimized Treatment
Acute Lymphoblastic Leukemia
Study of Fc-Optimized Anti-CD19 Antibody (MOR00208) to Treat B-cell Acute Lymphoblastic Leukemia(B-ALL)
This is an open-label, multicentre study to characterize the safety and preliminary efficacy of the human anti CD19 antibody MOR00208 in adult subjects with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL)
- Trial name
- NCT01685021
- Testing
- MOR00208 (formerly Xmab5574)
- Where
- 3 sites in United States
- Volunteers
- 22 people
- Sponsor
- MorphoSys AG
Bradycardia, Heart Failure
ECG Belt to Assess Electrical Synchronization
The objective of the study is to assess the utility of ECG Belt to understand the conduction and ECG characteristics of Left Bundle Branch Pacing (LBBAP) and His-Optimized Cardiac Resynchronization Therapy (HOT-CRT) and compare…
- Trial name
- NCT04583709
- Testing
- ECG Belt
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Pugazhendhi Vijayaraman
HIV Infections, Acquired Immunodeficiency Syndrome
Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)
This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.
- Trial name
- NCT00105157
- Testing
- Comparator: MK0518, MK0518
- Volunteers
- 179 people
- Sponsor
- Merck Sharp & Dohme LLC
HIV Infections
Raltegravir With Optimized Background Therapy (OBT) in Multiple Experienced HIV-infected Patients
The purpose of this study is to evaluate the efficacy of raltegravir with optimized background therapy (OBT) in multiple-experienced HIV infected patients, measured by the proportion of patients with undetectable viral load and…
- Trial name
- NCT01190124
- Volunteers
- 151 people
- Sponsor
- Doroana, Maria Manuela, M.D.
HIV Infections
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes).
- Trial name
- MOTIVATE 1 (NCT00098306)
- Testing
- Maraviroc (UK-427,857), Optimized Background Therapy
- Where
- 22 sites in United States, Canada
- Volunteers
- 601 people
- Sponsor
- ViiV Healthcare
Anal Canal Squamous Cell Carcinoma, Stage I Anal Cancer AJCC v8
Linear Energy Transfer (LET)-Optimized Intensity Modulated Proton Therapy (IMPT) as a Component of Definitive Chemoradiation for Newly Diagnosed Squamous Cell Carcinoma of the Anal Canal: a Feasibility Trial
This phase II trial studies the side effects of LET-IMPT and standard chemotherapy, and how well they work in treating patients with newly diagnosed stage I-III anal canal squamous cell cancer.
- Conditions
- Anal Canal Squamous Cell Carcinoma, Stage I Anal Cancer AJCC v8, Stage II Anal Cancer AJCC v8, Stage IIA Anal Cancer AJCC v8
- Trial name
- NCT03690921
- Testing
- Cisplatin, Fluorouracil, Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- M.D. Anderson Cancer Center
Heart Failure
Conduction System Pacing Optimized Therapy
The purpose of the CSPOT study is to determine the best mode of cardiac resynchronization therapy (CRT) pacing for different populations of CRT patients, comparing traditional biventricular or left ventricular pacing (BiV)…
- Trial name
- CSPOT (NCT04905290)
- Testing
- Left ventricular coronary sinus (BiV) configuration, Conduction system pacing-only configuration, Conduction System Pacing Optimized Therapy (CSPOT) configuration
- Where
- 12 sites in United States, Ireland and 2 more
- Volunteers
- 60 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
HIV
Randomized, Double-Blind, Placebo-Controlled Trial, Followed by Single-Arm Treatment of PRO 140
This is a Phase 2b/3, multi-center, two part study, designed to evaluate the efficacy, safety, and tolerability of PRO 140 in conjunction with existing ART (failing regimen) for one week and Optimized Background Therapy (OBT) for…
- Trial name
- PRO140 (NCT02483078)
- Testing
- PRO 140, Optimized Background Regimen
- Where
- 36 sites in United States, Puerto Rico
- Volunteers
- 52 people
- Sponsor
- CytoDyn, Inc.
Attention Deficit Hyperactivity Disorder
A Pivotal Efficacy Trial to Evaluate HLD200 in Children With ADHD in a Classroom Setting
This Phase 3 pivotal efficacy trial will examine the effects of HLD200 (methylphenidate) in patients aged 6-12 years with ADHD in a laboratory classroom setting.
- Trial name
- NCT02493777
- Testing
- HLD200 methylphenidate hydrochloride (MPH) Capsules
- Where
- 7 sites in United States
- Volunteers
- 125 people
- Sponsor
- Ironshore Pharmaceuticals and Development, Inc
Advanced Parkinson's Disease
Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
The primary objective of this study was to demonstrate the superiority of levodopa - carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12 weeks.
- Trial name
- NCT00660387
- Testing
- Levodopa carbidopa intestinal gel (LCIG), Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets, CADD-Legacy® 1400 ambulatory infusion pump
- Where
- 14 sites in United States, New Zealand
- Volunteers
- 35 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Recurrent Glioblastoma, Recurrent Malignant Glioma
Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
This phase I trial studies the side effects and best dose of genetically modified T-cell immunotherapy in treating patients with malignant glioma that has come back (recurrent) or has not responded to therapy (refractory).
- Conditions
- Recurrent Glioblastoma, Recurrent Malignant Glioma, Recurrent WHO Grade II Glioma, Recurrent WHO Grade III Glioma
- Trial name
- NCT02208362
- Testing
- Arm 1: IL13Ra2-specific CAR Tcm cells, Arm 2: IL13Ra2-specific CAR Tcm cells, Arm 3: IL13Ra2-specific CAR Tcm cells
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- City of Hope Medical Center
Anterior Wall Acute Myocardial Infarction
Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack
The purpose of this study is to evaluate the feasibility of the delivery of SuperSaturated Oxygen (SSO2) Therapy for 60 minutes selectively into the left main coronary artery (LMCA).
- Trial name
- NCT01630707
- Testing
- SuperSaturated Oxygen (SS02) Therapy
- Where
- 4 sites in United States
- Volunteers
- 20 people
- Sponsor
- TherOx
Hypertension, Resistant to Conventional Therapy
Distal Renal Denervation
Objective of this study is to evaluate whether a distal mode of endovascular renal denervation with the treatment performed primarily in segmental branches of renal artery is more effective than conventional mode of the…
- Trial name
- NCT02667912
- Testing
- Distal renal denervation, Conventional renal denervation
- Where
- Russia
- Volunteers
- 55 people
- Sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
Depression
African American Knowledge Optimized for Mindfully Healthy Adolescents
The purpose of this study was to better understand how African American families identify and treat emotional and behavioral concerns associated with depression in their adolescent youth.
- Trial name
- AAKOMA (NCT00578318)
- Testing
- Motivational Interviewing Active
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Georgetown University
HIV-1, HIV Infections
Phase 3 Open-Label Study to Evaluate Switching From Optimized Stable Antiretroviral Regimens Containing Darunavir to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Fixed Dose Combination (FDC) Plus Darunavir (DRV) in Treatment Experienced HIV-1 Positive Adults
The primary objective of this study is to evaluate the efficacy of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed dose combination (FDC) plus darunavir (DRV) relative to current antiretroviral…
- Conditions
- HIV-1, HIV Infections, Acquired Immunodeficiency Syndrome
- Trial name
- NCT01968551
- Testing
- E/C/F/TAF, DRV, Baseline DRV- containing ARV regimen
- Where
- 62 sites in United States, Canada
- Volunteers
- 158 people
- Sponsor
- Gilead Sciences
Advanced Parkinson's Disease
A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian Medications
The primary objective of this study is to measure the efficacy of ABT-SLV187 in subjects with advanced Parkinson's disease.
- Trial name
- NCT01960842
- Testing
- Levodopa-carbidopa intestinal gel, CADD-Legacy® 1400 ambulatory infusion pump, PEG tube
- Volunteers
- 31 people
- Sponsor
- AbbVie
Bipolar Disorder
Effectiveness of Lithium Plus Optimized Medication in Treating People With Bipolar Disorder
This study evaluated whether lithium included as part of optimized medication treatment improved overall level of illness, symptoms of mania and depression, and quality of life in people with bipolar disorder.
- Trial name
- LiTMUS (NCT00667745)
- Testing
- Lithium Carbonate, Optimized Treatment (OPT)
- Where
- 6 sites in United States
- Volunteers
- 283 people
- Sponsor
- National Institute of Mental Health (NIMH)
HIV
Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced Patients With Multi-Drug Resistant HIV-1
Ibalizumab is a monoclonal antibody that works by blocking HIV entry into the immune system cells (CD4+ or T-cells) the virus typically infects.
- Trial name
- NCT02707861
- Testing
- ibalizumab, Optimized Background Regimen
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 79 people
- Sponsor
- TaiMed Biologics Inc.
Hemophilia B
Dose Confirmation Trial of AAV5-hFIXco-Padua
This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase.
- Trial name
- NCT03489291
- Testing
- AAV5-hFIXco-Padua (AMT-061)
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Hypertriglyceridemia, HIV Infection
Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects
In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in…
- Trial name
- BuLLET (NCT01010399)
- Testing
- Lovaza, fosamprenavir/ritonavir
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Felizarta, Franco, M.D.