810 matching studies

Sponsor Condition of Interest
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly...
Arog Pharmaceuticals, Inc. Newly Diagnosed FLT3 Mutated AML
A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation.... expand

A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase.

Type: Interventional

Start Date: Aug 2018

open study

Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction.
Massachusetts General Hospital Acute Kidney Injury
The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass. expand

The purpose of this study is to determine whether nitric oxide is effective in the treatment of acute kidney injury in cardiac surgical patients with sign and laboratory data suggesting endothelial dysfunction undergoing prolonged cardiopulmonary bypass.

Type: Interventional

Start Date: Feb 2017

open study

IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic...
Massachusetts General Hospital IDH1 Mutation Myeloid Neoplasms
This research study is studying a drug as a possible treatment for IDH1-mutant myeloid neoplasms. -The drug involved in this study is ivosidenib (AG-120) expand

This research study is studying a drug as a possible treatment for IDH1-mutant myeloid neoplasms. -The drug involved in this study is ivosidenib (AG-120)

Type: Interventional

Start Date: Jan 2019

open study

A Study of the Safety and Efficacy of Atezolizumab Administered in Combination With Bevacizumab and/or...
Hoffmann-La Roche Solid Tumor
This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants... expand

This study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab in combination with bevacizumab, bevacizumab + oxaliplatin, leucovorin and 5-fluorouracil (5-FU) (FOLFOX), vanucizumab, nab-paclitaxel + gemcitabine, FOLFOX, or 5-FU + cisplatin, in participants with solid tumors.

Type: Interventional

Start Date: Apr 2016

open study

Developing a Positive Psychology Intervention to Promote Health Behaviors in Metabolic Syndrome: RCT
Massachusetts General Hospital Metabolic Syndrome
Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-MI group-based physical activity intervention and outcome assessments in patients with MetS. Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants... expand

Specific Aim #1 (Feasibility; primary aim): To assess the feasibility of the PP-MI group-based physical activity intervention and outcome assessments in patients with MetS. Hypothesis: The PP exercises and MI-based goal-setting sessions will be feasible: most (≥50%) of participants will complete 6/9 exercises/sessions. Furthermore, the investigators will be able to obtain objective physical activity measurement follow-up data from at least 80% of enrolled participants at the end of the intervention and 24 weeks later. Specific Aim #2 (Acceptability): To assess whether the intervention is acceptable to participants, as measured by ratings provided after each PP-MI session. Hypothesis: The intervention will be acceptable: participants will rate the PP-MI exercises with a mean score of at least 7 out of 10 on ease of completion and helpfulness. Specific Aim #3 (Outcomes): To assess whether this preliminary intervention appears to result in improvement of physical activity, related health behaviors (sedentary time, diet quality), psychological well-being (optimism, positive affect, anxiety, depression), and the exploratory outcomes of MetS-relevant physiological markers (e.g., blood pressure, weight, chart-reviewed lipids and HbA1C). Hypothesis a: The intervention will lead to improvements in physical activity, related health behaviors, optimism and positive affect, reductions in depression and anxiety at 9 weeks and 24 weeks compared to baseline (or the start of the intervention, for the WLC group). Hypothesis b: The hypothesis is that there will be improvements in the exploratory outcomes of the physiological markers, even if they do not reach significance.

Type: Interventional

Start Date: Jul 2019

open study

A Phase IB/II Study of Alectinib Combined With Cobimetinib in Advanced ALK-Rearranged (ALK+) NSCLC
Massachusetts General Hospital Non-small Cell Lung Cancer
This research study is studying a drug combination as a possible treatment for anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer. The drugs involved in this study are: - Alectinib - Cobimetinib expand

This research study is studying a drug combination as a possible treatment for anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer. The drugs involved in this study are: - Alectinib - Cobimetinib

Type: Interventional

Start Date: Sep 2017

open study

Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
Massachusetts General Hospital Substance Use Disorders Bipolar Disorder Mood Disorders
The purpose of this study is to determine whether quetiapine is effective in the treatment of youth with co-occurring substance use disorders and severe mood dysregulation. expand

The purpose of this study is to determine whether quetiapine is effective in the treatment of youth with co-occurring substance use disorders and severe mood dysregulation.

Type: Interventional

Start Date: Jan 2017

open study

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep
Massachusetts General Hospital Postoperative Delirium Sleep Anesthesia
This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical patients. expand

This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical patients.

Type: Interventional

Start Date: Mar 2017

open study

A Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of TAK-981 in Adult Participants...
Millennium Pharmaceuticals, Inc. Neoplasms Lymphoma
The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors or lymphomas. expand

The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors or lymphomas.

Type: Interventional

Start Date: Oct 2018

open study

Study of Pembrolizumab (MK-3475) in Adults With Recurrent/Metastatic Cutaneous Squamous Cell Carcinoma...
Merck Sharp & Dohme Corp. Squamous Cell Carcinoma
The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation... expand

The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in adult participants with recurrent or metastatic(R/M) cutaneous Squamous Cell Carcinoma (cSCC) or locally advanced (LA) unresectable cSCC that is not amenable to surgery and/or radiation and/or systemic therapies.

Type: Interventional

Start Date: Oct 2017

open study

Study of Efficacy and Safety of Pembrolizumab Plus Platinum-based Doublet Chemotherapy With or Without...
Novartis Pharmaceuticals Non-small Cell Lung Cancer
This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and tolerability (safety... expand

This is a phase III study of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab in previously untreated locally advanced or metastatic non-squamous and squamous NSCLC subjects. The study will assess primarily the safety and tolerability (safety run-in part) of pembrolizumab plus platinum-based doublet chemotherapy with canakinumab and then the efficacy (double-blind, randomized, placebo controlled part) of pembrolizumab plus platinum-based doublet chemotherapy with or without canakinumab.

Type: Interventional

Start Date: Dec 2018

open study

A Psychological-behavioral Intervention for Physical Activity in Type 2 Diabetes
Massachusetts General Hospital Type2 Diabetes
The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention versus a motivational interviewing (MI) health education intervention in a group of... expand

The focus of this study is to examine the feasibility, acceptability, and impact of a customized, combined positive psychology and motivational interviewing (PP-MI) health behavior intervention versus a motivational interviewing (MI) health education intervention in a group of patients with type 2 diabetes (T2D).

Type: Interventional

Start Date: Jul 2017

open study

A Study of LY3214996 Administered Alone or in Combination With Other Agents in Participants With Advanced/Metastatic...
Eli Lilly and Company Advanced Cancer Metastatic Melanoma Metastatic Non-small Cell Lung Cancer Metastatic Pancreatic Ductal Adenocarcinoma Colorectal Cancer
The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer. expand

The purpose of this study is to determine the safety of an extracellular signal regulated kinase (ERK1/2) inhibitor LY3214996 administered alone or in combination with other agents in participants with advanced cancer.

Type: Interventional

Start Date: Sep 2016

open study

Web Based Orthopaedic Sports Medicine Registry
Arthrex, Inc. Degenerative and Traumatic Pathology of the Knee Degenerative and Traumatic Pathology of the Shoulder and Elbow Degenerative and Traumatic Pathology of the Foot and Ankle Degenerative and Traumatic Pathology of the Hand and Wrist Degenerative and Traumatic Pathology of the Hip
The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with... expand

The purpose of this study is to establish an international, web based clinical registry to collect baseline characteristics of patients undergoing orthopaedic, sports medicine, arthroscopy, and related surgery, and the subsequent outcomes and cost-effectiveness associated with the surgical procedures and nonoperative treatments.

Type: Observational [Patient Registry]

Start Date: Sep 2010

open study

Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Adults With Primary Sclerosing Cholangitis
Gilead Sciences Primary Sclerosing Cholangitis
The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC). expand

The primary objective of this study is to evaluate whether cilofexor reduces the risk of fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).

Type: Interventional

Start Date: Mar 2019

open study

A Study Evaluating the Safety and Efficacy of Idasanutlin in Combination With Cytarabine and Daunorubicin...
Hoffmann-La Roche Acute Myeloid Leukemia
This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single... expand

This Phase Ib/II, open-label, multicenter, non-randomized study will evaluate the safety, efficacy, and pharmacokinetics of idasanutlin when it is given in combination with cytarabine and daunorubicin in induction, in combination with cytarabine in consolidation, and as a single agent in maintenance for treating participants with acute myeloid leukemia (AML).

Type: Interventional

Start Date: Mar 2019

open study

Adavosertib in Treating Patients With SETD2-Deficient Locally Advanced or Metastatic Solid Tumors
National Cancer Institute (NCI) Clear Cell Renal Cell Carcinoma Locally Advanced Malignant Solid Neoplasm Metastatic Malignant Solid Neoplasm Metastatic Renal Cell Carcinoma Stage III Renal Cell Cancer AJCC v8
This phase II trial studies how well adavosertib works in treating patients with SETD2-deficient solid tumors that have spread to other places in the body (advanced/metastatic). Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.... expand

This phase II trial studies how well adavosertib works in treating patients with SETD2-deficient solid tumors that have spread to other places in the body (advanced/metastatic). Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Type: Interventional

Start Date: May 2018

open study

Incidence of Difficult Airway and Difficult Neuraxial Placement in Obstetric Patients
Brigham and Women's Hospital Indication for Care or Intervention Related to Labor or Delivery With Baby Delivered
Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is... expand

Anesthesiologists commonly administer pain relief during labor or providing anesthesia for cesarean delivery. Two main methods are used to achieve these goal: "Regional anesthesia" where the mother is given medication through a needle or catheter in her back and the mother is kept awake, or "General anesthesia", where the mother is given intravenous medication and is kept asleep. Regional anesthesia uses a needle to enter a narrow space in the mother's back where medications can be given. In some patients, it takes longer to find this target space in the back. In emergency situation, however, there is often little time to find this space, and the backup method would be the general anesthesia technique. If general anesthesia is required, a breathing tube needs to be inserted to help support the mother's breathing. In some patients, it is harder to insert the breathing tubes, so knowing this in advanced helps anesthesiologists create a safe plan for the patients. A lot of research has been done to determine factors that would predict which patients would need more time and preparation for general anesthesia and regional anesthesia. The purpose of this study is to study how common it is for the pregnant patients who have a difficult regional and general anesthesia.

Type: Observational

Start Date: Jul 2014

open study

CANTATA: CB-839 With Cabozantinib vs. Cabozantinib With Placebo in Patients With Metastatic Renal Cell...
Calithera Biosciences, Inc Advanced Renal Cell Carcinoma Metastatic Renal Cell Carcinoma
This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma with a clear cell component. expand

This clinical trial is a randomized Phase 2 evaluation of CB-839 (telaglenastat) in combination with cabozantinib versus placebo with cabozantinib in patients with advanced or metastatic Renal Cell Carcinoma with a clear cell component.

Type: Interventional

Start Date: Mar 2018

open study

A Study of LY3434172, a PD-1 and PD-L1 Bispecific Antibody, in Advanced Cancer
Eli Lilly and Company Advanced Cancer
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors. expand

The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3434172, a PD-1/PD-L1 bispecific antibody, in participants with advanced solid tumors.

Type: Interventional

Start Date: May 2019

open study

A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone...
Genentech, Inc. Breast Cancer
This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone−releasing hormone (LHRH) agonist in participants with advanced... expand

This study will evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of GDC-9545 as a single agent and in combination with palbociclib and/or luteinizing hormone−releasing hormone (LHRH) agonist in participants with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 [HER2]-negative) breast cancer.

Type: Interventional

Start Date: Nov 2017

open study

A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3...
Turning Point Therapeutics, Inc. Locally Advanced Solid Tumors Metastatic Solid Tumors
Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an... expand

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction. Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Type: Interventional

Start Date: Feb 2017

open study

Depression and Body Image Distress Following Mastectomy With Reconstruction
Massachusetts General Hospital Breast Cancer BRCA1 Mutation BRCA2 Mutation
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial... expand

Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. Reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. However, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. The present study aims to address this critical gap. In women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.

Type: Observational

Start Date: Oct 2017

open study

Integrating Mind Body Skills and Physical Activity in Older Adults With Mild Cognitive Impairment (MCI)...
Massachusetts General Hospital Chronic Pain Mild Cognitive Impairment Older Adults Physical Activity
The first aim of the study are to adapt an evidence-based mind-body program, the Relaxation Response Resiliency Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is the the p3RP integrated with a commerical DMD, the Fitbit, to meet the... expand

The first aim of the study are to adapt an evidence-based mind-body program, the Relaxation Response Resiliency Program for Chronic Pain (p3RP), and the p3RP-Digital Monitoring Device (p3RP-DMD), which is the the p3RP integrated with a commerical DMD, the Fitbit, to meet the needs of older adults with chronic pain and mild cognitive impairment (MCI). The second aim is to examine feasibility, acceptability, satisfaction, and credibility of the newly adapted programs (Active Brains and Active Brains with Fitbit).

Type: Interventional

Start Date: Aug 2019

open study

A Phase 1 Study of BLU-554 in Patients With Hepatocellular Carcinoma
Blueprint Medicines Corporation Hepatocellular Carcinoma (HCC)
This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU- 554 administered orally in patients with FGF19 IHC+ hepatocellular carcinoma... expand

This is a Phase 1, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antineoplastic activity of BLU- 554 administered orally in patients with FGF19 IHC+ hepatocellular carcinoma (HCC). The study consists of 3 parts, a dose-escalation part (Part 1), an expansion part (Part 2) exploring a once daily (qd) dosing schedule at the recommended Phase 2 dose (RP2D), and a Part 3 expansion of the qd dosing schedule at the RP2D in TKI naive patients.

Type: Interventional

Start Date: Jul 2015

open study