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NCT ID: NCT03137771 Active, not recruiting - Clinical trials for Stage IV Non-Small Cell Lung Cancer

Maintenance Chemotherapy With or Without Local Consolidative Therapy in Treating Patients With Stage IV Non-small Cell Lung Cancer

Start date: April 7, 2017
Phase: Phase 2
Study type: Interventional

This randomized phase II/III trial studies how well giving maintenance chemotherapy with or without local consolidation therapy works in treating patients with stage IV non-small cell lung cancer. Drugs used in maintenance chemotherapy, such as docetaxel, pemetrexed disodium, erlotinib hydrochloride, and gemcitabine 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. Local consolidation therapy such as radiation/stereotactic body radiation or surgery may kill cancer cells left after initial treatment. Giving maintenance chemotherapy and local consolidation therapy together may work better than maintenance chemotherapy alone in treating patients with stage IV non-small cell lung cancer.

NCT ID: NCT03133650 Active, not recruiting - Clinical trials for Esophagogastric Cancer

A Trial of a New Type of Photodynamic Therapy (VTP) in the Treatment of Patients With Cancer of the Esophagus Who Have Trouble Swallowing

Start date: April 26, 2017
Phase: Phase 1
Study type: Interventional

The purpose of this study is to establish the highest dose of laser light for WST-11 VTP to treat obstruction from esophageal cancer that can be safely given.

NCT ID: NCT03126019 Active, not recruiting - Lymphoma Clinical Trials

A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

CITADEL-203
Start date: March 14, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.

NCT ID: NCT03110562 Active, not recruiting - Multiple Myeloma Clinical Trials

Bortezomib, Selinexor, and Dexamethasone in Patients With Multiple Myeloma

BOSTON
Start date: May 24, 2017
Phase: Phase 3
Study type: Interventional

This Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study will compare the efficacy and health-related quality of life (HR-QoL) and assess the safety of selinexor plus bortezomib (Velcade) plus low-dose dexamethasone (SVd) versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.

NCT ID: NCT03108781 Active, not recruiting - Dementia Clinical Trials

The Role of Aromatherapy With Lavender Oil in the Long-term Care on a Patients Behavioral Problems Associated With Dementia

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Testing of Lavender Oil aromatherapy effect on behavior disorders in patients with severe dementia who are hospitalized in the ward for the mentally frail.

NCT ID: NCT03106779 Active, not recruiting - Clinical trials for Chronic Myelogenous Leukemia

Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIs

Start date: November 29, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this pivotal study was to compare the efficacy of asciminib (ABL001) with that of bosutinib in the treatment of patients with CML-CP having previously been treated with a minimum of two prior ATP-binding site TKIs. Patients intolerant to the most recent TKI therapy must have had BCR-ABL1 ratio > 0.1% IS at screening and patients failing their most recent TKI therapy must have met the definition of treatment failure as per the 2013 European LeukemiaNet (ELN) recommendations. Patients with documented treatment failure as per 2013 ELN recommendations while on bosutinib treatment had the option to switch to asciminib treatment within 96 weeks after the last patient has been randomized on study.

NCT ID: NCT03105102 Active, not recruiting - Crohn's Disease Clinical Trials

A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease

FORTIFY
Start date: April 9, 2018
Phase: Phase 3
Study type: Interventional

The study consists of 4 sub-studies, as follows: - Sub-study 1 (Randomized, double-blind, placebo controlled study) to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in participants with moderately to severely active Crohn's disease (CD) who responded to intravenous risankizumab induction treatment in Study M16-006 or Study M15-991; - Sub-study 2 (Randomized, exploratory maintenance study) to evaluate the efficacy and safety of two different dosing regimens for risankizumab as maintenance therapy in participants who responded to induction treatment in Study M16-006 or Study M15-991; - Sub-study 3 (Open-label, long-term extension study) to evaluate long-term safety of risankizumab in participants who completed Sub-study 1, Sub-study 2, another AbbVie risankizumab Crohn's disease study, or participants who responded to induction treatment in Study M16-006 or Study M15-991 with no final endoscopy due to the Covid-19 pandemic. Additional objectives are to further investigate long-term efficacy and tolerability of risankizumab; - Sub-study 4 (Open-label On Body Injector (OBI) administration and long-term extension study) to evaluate patient-reported outcomes, efficacy, safety, tolerability, and pharmacokinetics of risankizumab administered via OBI in participants who are receiving maintenance treatment with risankizumab. - OL CTE to ensure uninterrupted care in accordance with local regulations until risankizumab is commercially available for participants who completed Sub-study 3, Sub-study 4.

NCT ID: NCT03104400 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD)

SELECT - PsA 1
Start date: April 27, 2017
Phase: Phase 3
Study type: Interventional

This study includes two periods. The main objective of Period 1 is to compare the efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo and versus adalimumab (Humira®) in participants with moderately to severely active psoriatic arthritis (PsA) who have had an inadequate response to non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of upadacitinib 15 mg and 30 mg QD versus placebo for the prevention of structural progression. The objective of Period 2 is to evaluate the long-term safety, tolerability and efficacy of upadacitinib 15 mg and 30 mg QD in participants who have completed Period 1.

NCT ID: NCT03100474 Active, not recruiting - Parkinson's Disease Clinical Trials

Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:

Start date: December 2016
Phase:
Study type: Observational [Patient Registry]

A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.

NCT ID: NCT03084445 Active, not recruiting - Clinical trials for Exposure to Environmental Pollution

Impact of Exposure to Environmental Pollutants on Birth Outcomes in an Israeli Cohort

Start date: September 2013
Phase:
Study type: Observational [Patient Registry]

Objectives and hypothesis The scale and diversity of chemicals in worldwide use today is vast. Many of these chemicals are released into the environment where they are found in air, water, soil, house dust, and in the food supply, resulting in exposure to humans. Characterizing the extent of exposure and the effects of exposure in vulnerable populations, such as pregnant women and children, is of the utmost importance as the chemical structure of many of these compounds resembles hormones such as estrogen, testosterone and thyroid hormone, affect neurodevelopment and other health effects. Here, we focus on few classes of compounds: heavy metals, volatile organic compounds (VOCs), brominated flame retardants (PBDEs) and phthalates. We will characterize the extent of exposure to pregnant women and their infants in Israel, where biomonitoring studies in the general population are scarce. We will also examine selected outcomes in pregnant women and their offspring in relation to these compounds, and to establish a biorepository for further studies. Specific Aims: 1. To assess Heavy metals, VOCs, PBDEs and phthalates body burdens through measurement of these chemicals in maternal and paternal serum and urine, cord blood, breastmilk and neonatal meconium among several representative sub-populations. 2. To examine associations between exposure to heavy metals, VOCs, PBDEs and phthalates and (a) pregnancy complications, (b) anthropometrics at birth (i.e. birth weight adjusted for gestational age, ponderal index, head circumference adjusted for gestational age), and (c) cryptorchidism incidence, (d) maternal and infant thyroid function. 3. To establish a bio repository of these media for future studies and to establish follow up methods for this cohort to later assess development and growth in the infants, toddlers and children. Patients and Methods: Patients will be recruited from three delivery rooms in Israel: "Assaf Harofeh Medical Center" , "Lis (Sorasky) Medical Center" and "Rambam Medical Center", all together with around 21,000 births annually, representing all sub-populations in Israel. 500 mother-father-infant trios (for a total of 4500) will be recruited. When arriving to the delivery room, after signing the informed consent, blood and urine will be withdrawn from the mothers and fathers for Heavy metals, VOCs, PBDEs and phthalates levels. At the same time thyroid function tests will also be taken from the mothers. After delivery, cord blood will be taken, as well as meconium from the neonate. Hair, nails and Breastmilk will also be collected. From the mothers The samples will be analyzed for heavy metals, VOCs, PBDEs and phthalates. During their stay at the hospital, mothers and fathers will fill out a standardized questionnaire regarding life style factors, background information, and exposure opportunities. Detailed information on family history, previous and present pregnancy, method of delivery, perinatal complications, and pregnancy outcome will be recorded from the medical files. Expected contribution to environmental health in Israel: This will be the first data on sub-populations exposure to Heavy metals, VOCs, PBDEs and phthalates in Israel. Neonatal meconium levels will provide important information on magnitude of exposure during the last months of pregnancy, and, thus, will provide insights into the bioaccumulative nature of these Heavy metals, VOCs, PBDEs and phthalates during early stages of human development, important data for future risk assessments. Our comprehensive approach will provide detailed information on the status of each subject. Such novel knowledge would also lead to the development of preventive and counseling strategies for men and women with high BFR and phthalates exposure in order to minimize the risks of adverse outcomes. Knowledge transfer strategies are essential in order that the general public, health professionals, scientists and policy/law regulators have the appropriate knowledge on which to base their understandings and recommendations for the future. In this way, the knowledge that is generated will facilitate the development of prevention strategies to minimize health risks of Israel population.