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NCT ID: NCT02531321 Terminated - HIV Clinical Trials

Protease Inhibitors and Combined Oral Contraceptive Pharmacokinetics and Pharmacodynamics

Start date: August 2015
Phase: Phase 4
Study type: Interventional

The project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in HIV-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptives. In addition, the prevalence of ovulation will be measured in each group. Participants will take a combined oral contraceptive containing levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly serum progesterones. On the final day, they will complete a pharmacokinetic study. The investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/mL, will be unchanged. This study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of a combined oral contraceptive containing the progestin levonorgestrel. In addition, no previous studies have rigorously assessed ovulation in women taking protease inhibitors and combined oral contraceptives. As a result, this study will provide new information correlating pharmacokinetic changes with effects on ovulation.

NCT ID: NCT02531308 Terminated - Clinical trials for Diffuse Large B-Cell Lymphoma

Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL)

DLBCL
Start date: July 2015
Phase: Phase 2
Study type: Interventional

Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)

NCT ID: NCT02531295 Terminated - HIV Clinical Trials

Immunologic Response to Kansui in Treated HIV+ Individuals: a Dose Escalation Study

Start date: May 15, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety and bioactivity of an herbal supplement called "kansui," which contains several active ingredients such as ingenols that may have a role in helping clear HIV from the body. Kansui has been used in traditional Chinese medicine for centuries to treat various ailments such as for eliminating excess fluid in the abdomen or lungs, loosening phlegm from the chest, and relieving constipation. Based on preliminary in vitro data from our group, kansui extract powder is a potent activator of HIV transpcription in latently infected Jurkat cells. The investigators' hypothesis is that kansui extract powder prepared as tea will be safe and well-tolerated, elicit an in vivo immunologic response, and at the doses administered, increase HIV transcription in latently-infected cells among HIV-infected patients on suppressive antiretroviral therapy.

NCT ID: NCT02530502 Terminated - Adult Glioblastoma Clinical Trials

Radiation Therapy With Temozolomide and Pembrolizumab in Treating Patients With Newly Diagnosed Glioblastoma

Start date: September 30, 2015
Phase: Phase 1
Study type: Interventional

The purpose of phase I trial is to determine the safest, most effective dose of MK-3475 (pembrolizumab), when used with radiotherapy and temozolomide for treating newly diagnosed patients with glioblastoma (GBM). Temozolomide binds to the deoxyribonucleic acid (DNA), changes it, and triggers the death of tumor cells. MK-3475 is an investigational drug, it is not currently approved by the Federal Drug Administration (FDA) for use in treating GBM but it is approved for treating melanoma. MK-3475 works by targets the local tumor immune-protection in solid tumors. It is hoped the addition of MK-3475 to the usual treatment for GBM will improve the current treatment.

NCT ID: NCT02530437 Terminated - Clinical trials for Gastroesophageal Junction Adenocarcinoma

Taladegib, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Localized Esophageal or Gastroesophageal Junction Cancer

Start date: March 7, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This phase IB/II trial studies the side effects of taladegib, paclitaxel, carboplatin, and external beam radiation therapy and to see how well they work in treating patients with esophageal or gastroesophageal junction cancer found only in the tissue or organ where it began, and has not spread to nearby lymph nodes or to other parts of the body (localized). Taladegib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving taladegib, paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.

NCT ID: NCT02530307 Terminated - Ischemic Stroke Clinical Trials

HT-3951 vs. Placebo in Stroke Rehabilitation

RESTORE
Start date: February 2016
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

NCT ID: NCT02530125 Terminated - Clinical trials for Stage IV Diffuse Large B-Cell Lymphoma

Pidilizumab in Treating Patients With Stage III-IV Diffuse Large B-Cell Lymphoma Following First Remission

Start date: September 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate pidilizumab and its effect, bad and/or good, on the immune system in relation to its ability to fight cancer cells. Many cancers can be brought to a phase called complete remission (no cancer is found) but have a chance that they may come back. Researchers are working to improve therapy and to find new drugs that lower the chance of disease coming back. This study uses a drug called pidilizumab. The drug targets our immune system. It can change how our immune system finds cancer cells. The drug may kill any remaining cancer cells that we cannot see with computed tomography (CT) scans. The drug, pidilizumab, is being studied in other cancers.

NCT ID: NCT02529696 Terminated - Anesthesia Clinical Trials

Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers

Start date: September 30, 2015
Phase:
Study type: Observational

Maintenance of analgesia during a patient stay in the hospital has been an important area of investigation after demonstrating a direct correlation between level of sedation and mortality in the ICU setting. This study will investigate the use of accelerometers in determining patient sedation level.

NCT ID: NCT02528318 Terminated - Clinical trials for Respiratory Distress Syndrome

Trial To Assess The Safety And Tolerability Of Lucinactant For Inhalation In Preterm Neonates 26 to 28 Weeks PMA

Start date: August 2015
Phase: Phase 2
Study type: Interventional

This study is to evaluate the safety and tolerability of lucinactant for inhalation, administered as an aerosol in up to four escalating doses to preterm neonates 26 to 28 weeks gestational age who are receiving nCPAP for RDS compared to neonates receiving nCPAP alone.

NCT ID: NCT02527681 Terminated - Clinical trials for Bacterial Infections

Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibiotics

Start date: November 22, 2016
Phase: Phase 1
Study type: Interventional

This study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.