
Search Clinical Trials
Sponsor Condition of Interest |
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Nab-Paclitaxel and Gemcitabine for Recurrent/Refractory Sarcoma
H. Lee Moffitt Cancer Center and Research Institute
Osteosarcoma
Ewing Sarcoma
Rhabdomyosarcoma
Soft Tissue Sarcoma
The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the
formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing
sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time... expand
The purpose of this study is to see if nab-paclitaxel combined with gemcitabine prevents the formation or growth of tumors in participants with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and other soft tissue sarcoma and to measure the length of time during and after treatment that their disease does not get worse. Researchers also want to find out if nab-paclitaxel combined with gemcitabine is safe and tolerable. Type: Interventional Start Date: Oct 2016 |
Pinhole Versus Tunnel for Soft Tissue Recession
Nehal Almehmadi
Gingival Recession
This is an assessor-blinded split-mouth randomized clinical study to compare root coverage
and gingival tissue thickness following two different surgical procedures for non-autologous
grafting: the pinhole surgical technique (PST) and tunnel technique.
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This is an assessor-blinded split-mouth randomized clinical study to compare root coverage and gingival tissue thickness following two different surgical procedures for non-autologous grafting: the pinhole surgical technique (PST) and tunnel technique. Type: Interventional Start Date: Jun 2020 |
Training Induced Muscle Exosome Release
John McCarthy
Metabolism
The primary objective of this study is to quantify miR-1 release from muscle in
extra-cellular vesicles following an acute resistance exercise bout and potential delivery to
subcutaneous adipose tissue in young healthy and obese adults.
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The primary objective of this study is to quantify miR-1 release from muscle in extra-cellular vesicles following an acute resistance exercise bout and potential delivery to subcutaneous adipose tissue in young healthy and obese adults. Type: Interventional Start Date: Mar 2019 |
A Clinical Study to Evaluate the Clinical Performance and Safety of LiquiBand FIX8® Versus AbsorbaTack™...
Advanced Medical Solutions Ltd.
Hernia
Inguinal Hernia
Femoral Hernia
Groin Hernia
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group).
Patients will be blinded to the fixation method used. The objective of this study is to
compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control
device (AbsorbaTack™)... expand
This is a multi-center, randomized controlled trial of 284 subjects (142 in each group). Patients will be blinded to the fixation method used. The objective of this study is to compare the efficacy and safety of the LiquiBand FIX8® device to the tack-based control device (AbsorbaTack™) for laparoscopic groin hernia (inguinal or femoral) repair. The primary outcome measure is an improvement in pain score measured by VAS at 6 months. Secondary outcomes include the ability to affix hernia mesh, the ability to approximate the peritoneum, recurrence rate, and quality of life (Carolina Comfort Scale). Type: Interventional Start Date: Jul 2019 |
The Peer-Based Retention of People Who Use Drugs in Rural Research
Oregon Health and Science University
Drug Use
Peer Influence
The purpose of this study is to, through several aims, test the effectiveness of peer-driven
intervention and inform methods to optimize engagement in research in people who use drugs
(PWUD) in rural America.
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The purpose of this study is to, through several aims, test the effectiveness of peer-driven intervention and inform methods to optimize engagement in research in people who use drugs (PWUD) in rural America. Type: Interventional Start Date: Mar 2019 |
Physical Activity Monitoring Among BMT Patients
Ming-Yuan Chih
Bone Marrow Transplantation
This study aims to evaluate the feasibility of an apple watch-based application to promote
physical activity among bone marrow transplant (BMT) patients.
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This study aims to evaluate the feasibility of an apple watch-based application to promote physical activity among bone marrow transplant (BMT) patients. Type: Interventional Start Date: Nov 2019 |
AHEAD 3-45 Study: A Study to Evaluate Efficacy and Safety of Treatment With Lecanemab in Participants...
Eisai Inc.
Preclinical Alzheimer's Disease
Early Alzheimer's Disease
The primary purpose of this study is to determine whether treatment with lecanemab is
superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite
5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with
lecanemab... expand
The primary purpose of this study is to determine whether treatment with lecanemab is superior to placebo on change from baseline of the Preclinical Alzheimer Cognitive Composite 5 (PACC5) at 216 weeks of treatment (A45 Trial) and to determine whether treatment with lecanemab is superior to placebo in reducing brain amyloid accumulation as measured by amyloid positron emission tomography (PET) at 216 weeks of treatment (A3 Trial). Type: Interventional Start Date: Jul 2020 |
Piloting Pathways With Lung Cancer Patients
Laurie McLouth
Metastatic Lung Cancer
The purpose of this research is to determine the feasibility of a new supportive
intervention, called Pathways, for patients with metastatic lung cancer.
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The purpose of this research is to determine the feasibility of a new supportive intervention, called Pathways, for patients with metastatic lung cancer. Type: Interventional Start Date: Jan 2020 |
Hydroxychloroquine in Individuals At-risk for Type 1 Diabetes Mellitus
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type1 Diabetes Mellitus
The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled
clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for
progression of T1D.
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The study is a 2-arm, double blinded, multicenter, 2:1 randomized, placebo controlled clinical trial. Subjects will receive hydroxychloroquine or placebo and close monitoring for progression of T1D. Type: Interventional Start Date: Aug 2018 |
Neural Mechanisms of Cannabinoid-impaired Decision-Making in Emerging Adults
University of Kentucky
Neurosciences
Substance-Related Disorders
Behavior Problem
Emerging adults are a particularly vulnerable group for experiencing the immediate and
potentially lifelong negative impacts of habitual cannabis use, and trends suggest that
cannabis use disorder (CUD) will soon escalate in this population. The proposed research will
combine... expand
Emerging adults are a particularly vulnerable group for experiencing the immediate and potentially lifelong negative impacts of habitual cannabis use, and trends suggest that cannabis use disorder (CUD) will soon escalate in this population. The proposed research will combine clinical pharmacology, non-invasive brain stimulation, and neuroimaging techniques to establish the brain mechanisms of cannabinoid-impaired decision-making processes in emerging adults with CUD. Results from this project will inform CUD prevention/treatment efforts in this high-risk group and address a growing public health concern. Type: Interventional Start Date: Jul 2017 |
Treatments Against RA and Effect on FDG-PET/CT
Brigham and Women's Hospital
Arthritis, Rheumatoid
In a randomized controlled clinical trial, investigators will compare the effects on
[18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from
two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate
responders... expand
In a randomized controlled clinical trial, investigators will compare the effects on [18F]-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) from two treatment regimens in rheumatoid arthritis (RA) patients deemed methotrexate inadequate responders (MTX-IRs). Two common RA treatments will be compared: triple therapy (sulfasalazine, methotrexate, and hydroxychloroquine) versus tumor necrosis factor (TNF) inhibitor (etanercept or adalimumab, plus background methotrexate for all subjects and hydroxychloroquine for subjects who were taking this at screening). Type: Interventional Start Date: Jul 2016 |
Prescription Medication Interactions
Sharon Walsh
Opioid Use
Sedative Use
This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo,
alone and in combination. The primary outcomes are related to pharmacodynamic measures
(subjective ratings of drug liking and other abuse-related effects; physiological outcomes)... expand
This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds. Type: Interventional Start Date: Mar 2019 |
The Effect of Various Strength Training Protocols in ACL Reconstructed Participants
Brian W. Noehren
Anterior Cruciate Ligament (ACL) Tear
Physical Therapy
The purpose of the study is to determine how two different blood flow restriction training
programs used in conjunction with standard rehabilitation affect leg strength. By doing this
study, the investigator hopes to learn if one program improves strength and function more... expand
The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working. There will be no charge to the participant for their physical therapy visits as long as they are part of the study The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires). The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form. The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will take an additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours total to complete both procedures. The investigator will accommodate participant preference for scheduling. Type: Interventional Start Date: Aug 2017 |
Alphanate in Immune Tolerance Induction Therapy
Grifols Therapeutics LLC
Hemophilia A, Congenital
This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label
study of approximately 25 male subjects with congenital hemophilia A who will receive their
first (primary) immune tolerance induction (ITI) treatment with Alphanate.
The study consists... expand
This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study of approximately 25 male subjects with congenital hemophilia A who will receive their first (primary) immune tolerance induction (ITI) treatment with Alphanate. The study consists of 2 phases: - An ITI Treatment Phase in which all eligible subjects will receive ITI treatment with Alphanate for a period of up to 33 months. Upon confirmation of complete immune tolerization, subjects will then enter a 12-month Prophylactic Phase. If, after 33 months of ITI, a subject has achieved partial immune tolerance, the subject will enter a 12-month Prophylactic Phase. - A 12-month Prophylactic Phase for all subjects who meet the criteria for complete or partial success to continue on a prophylactic dosing regimen of Alphanate. Type: Interventional Start Date: Jan 2018 |
Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer
Andrew C. James, MD
Prostate Cancer Recurrent
Treatment of recurrent oligometastatic prostate cancer may be enhanced by the addition of
Hydroxychloroquine to the current treatment regimens. Potential benefits of
Hydroxychloroquine include delayed disease progression and delayed initiation of androgen
deprivation therapy... expand
Treatment of recurrent oligometastatic prostate cancer may be enhanced by the addition of Hydroxychloroquine to the current treatment regimens. Potential benefits of Hydroxychloroquine include delayed disease progression and delayed initiation of androgen deprivation therapy (ADT), thus lessening morbidity, distressing side effects, and improving functioning and quality of life in men with recurrent prostate cancer. Building on prior research at Markey, patients recently diagnosed with recurrent oligometastatic prostate cancer will be approached about participating in this study. Per standard of care, these patients undergo either surgery or radiation, in addition participants of this clinical trial will also receive Hydroxychloroquine (400 mg per day, oral medication) for 3 months. It is expected that a participant will exhibit a 50% increase of tumor suppressor PAR-4, as well as few, if any, negative side effects from Hydroxychloroquine. Type: Interventional Start Date: Dec 2019 |
The ASTERS Study: Assessing the Role of Sphingolipids in AcuTE Respiratory Distress Syndrome (ARDS)
Sturgill
Acute Lung Injury
Acute Respiratory Distress Syndrome
Acute lung injury (ALI) and the more severe manifestation, acute respiratory distress
syndrome (ARDS) describe syndromes of acute onset, bilateral, inflammatory pulmonary
infiltrates and impaired oxygenation. ARDS/ALI are a continuum of disease which results in a
life threatening,... expand
Acute lung injury (ALI) and the more severe manifestation, acute respiratory distress syndrome (ARDS) describe syndromes of acute onset, bilateral, inflammatory pulmonary infiltrates and impaired oxygenation. ARDS/ALI are a continuum of disease which results in a life threatening, rapidly progressive illness and occurs in critically ill patients. Recent reports in the Journal of the American Medical Association (JAMA) highlight the significant public health impact ARDS/ALI has on the critically ill population in that despite robust research efforts, these illnesses continue to be under diagnosed, under treated, and continue to have a high mortality rate (≥ 40% of all confirmed diagnoses). The estimates for ARDS/ALI incidence vary due to inconsistencies with proper diagnosis and lack of valid biomarkers of disease; however, it is expected that anywhere from 20-50% of patients on mechanical ventilation will develop this disease. Previous work by our group has shown that sphingolipids play a multifaceted role in lung inflammation. Sphingolipid are a class of bioactive lipids that play a role in cellular processes such as apoptosis, cell migration, and adhesion. Ceramide is one species of sphingolipid the investigators have examined in both man and mouse. Our laboratory has shown that ceramide is up-regulated in pulmonary inflammation in mouse models of pneumonitis and is elevated in the exhaled breath condensate of mechanically ventilated patients at risk for ARDS/ALI. Our work coupled with the work of others highlighting a role for ceramide in chronic obstructive pulmonary disease (COPD), surfactant dysfunction, and infectious disease make ceramide a logical candidate biomarker that warrants further investigation. To our knowledge, there are no studies examining the role of ceramide as a biomarker in ARDS/ALI. Thus, our overarching hypothesis is that ceramide is elevated in the lungs of patients who develop ARDS/ALI. This lipid dysregulation accounts for the pathophysiology seen in this disease and may be a potential pharmacologic target for clinical treatment. Thus the purpose of this exploratory research is to maximize existing specimens to further evaluate ceramide as a biomarker for acute lung injury. Type: Observational Start Date: Apr 2019 |
A Causative Role for Amylin in Diabetic Peripheral Neuropathy
John Slevin
Type2 Diabetes
Peripheral Neuropathy
Three pieces of information lead to the basis for this study:
1. Individuals with Type-2 diabetes commonly develop peripheral neuropathy.
2. Increased production of the hormone amylin occurs in individuals who have Type-2
diabetes.
3. Aggregations of... expand
Three pieces of information lead to the basis for this study: 1. Individuals with Type-2 diabetes commonly develop peripheral neuropathy. 2. Increased production of the hormone amylin occurs in individuals who have Type-2 diabetes. 3. Aggregations of amylin was found in the peripheral vasculature of rats that overexpressed human amylin. The purpose of this study is to determine whether a correlation exists between the amount of amylin present in the upper extremities of human subjects with Type-2 diabetes and the extent to which symptoms of peripheral neuropathy are expressed in those subjects. The investigators will be testing this by initially collecting blood and skin biopsy samples from subjects, followed by measuring patient sensation and pain responses to heat, cold, and pressure in the upper extremities. Type: Observational Start Date: Feb 2018 |
A Pilot Study Using Autologous Regulatory T Cell Infusion Zortress (Everolimus) in Renal Transplant Recipients
Roberto Gedaly
End Stage Renal Disease
Kidney Transplant
This study will enroll individuals who have end stage renal disease and who are undergoing a
solitary kidney transplant. This study is investigating/evaluating the safety and
effectiveness of collecting, expanding and infusing a specific certain type of immune cell
known as... expand
This study will enroll individuals who have end stage renal disease and who are undergoing a solitary kidney transplant. This study is investigating/evaluating the safety and effectiveness of collecting, expanding and infusing a specific certain type of immune cell known as Regulatory T cells (Treg cells) to renal transplant recipients who are using Zortress (Everolimus) as immunosuppressive therapy. Treg cells, once they have been expanded in the laboratory to help prevent kidney rejection. Treg cells are collected from a participant's blood through a procedure called apheresis. Treg cells are a type of white blood cells that are able to suppress the activity of other immune cells responsible for organ rejection. The investigator plans to enroll 12 participants at the University of Kentucky. Type: Interventional Start Date: Mar 2019 |
Corazon de la Familia (Heart of the Family)
Gia Mudd
Risk Reduction Behavior
Diabetes Mellitus, Type 2
Cardiovascular Diseases
The Corazón de la Familia study is a randomized controlled trial to examine the effects of a
novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes
and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health... expand
The Corazón de la Familia study is a randomized controlled trial to examine the effects of a novel family-focused lifestyle modification intervention to reduce risk for type 2 diabetes and cardiovascular disease (CVD) among Hispanics/Latinos. Facilitated by community health workers, the family-focused intervention engages two members of a family in an educational program addressing lifestyle behaviors to support sustained engagement in healthy lifestyles among Hispanics with high risk for type 2 diabetes or CVD. In this study, we will conduct a randomized controlled trial using a 2-group design and compare the short-term and long-term impact of the family-focused active intervention to an individual-focused control condition on biological and behavioral type 2 diabetes and CVD risk factors. Furthermore, we will examine outcomes of participants in the family-focused intervention to determine how each family member's engagement in healthy lifestyle behaviors and level of support for the other family member's engagement in healthy lifestyle behaviors affects their own and their partner's outcomes. Type: Interventional Start Date: Oct 2017 |
Kentucky Communities and Researchers Engaging to Halt the Opioid Epidemic (CARE2HOPE)
University of Kentucky
Substance Use
HIV Infections
HCV Infection
Sexually Transmitted Infections (Not HIV or Hepatitis)
Overdose, Drug
This study will test the effects of an intervention to reduce substance use and related harms
among people leaving rural jails. This study will compare people in a re-entry health linkage
intervention with people who will get overdose education in jail. Everyone will take part in... expand
This study will test the effects of an intervention to reduce substance use and related harms among people leaving rural jails. This study will compare people in a re-entry health linkage intervention with people who will get overdose education in jail. Everyone will take part in follow-up surveys after release. Participants will be assigned to one of the two groups by chance based on when they are released from jail and when their county is randomly chosen to start the project.By doing this study, the investigators hope to learn if providing linkage to health services along with HIV, hepatitis C, and overdose education to people leaving rural jails will reduce substance use and related harms. Type: Interventional Start Date: Nov 2019 |
Study to Evaluate the Efficacy & Safety of the INTERCEPT Blood System for RBCs in Complex Cardiac Surgery...
Cerus Corporation
Anemia
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for
support of acute anemia in cardiovascular surgery patients based on the clinical outcome of
renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT... expand
The objective of this study is to evaluate the efficacy and safety of RBC transfusion for support of acute anemia in cardiovascular surgery patients based on the clinical outcome of renal impairment following transfusion of red blood cells (RBCs) treated with the INTERCEPT Blood System (IBS) for Red Blood Cells compared to patients transfused with conventional RBCs. Type: Interventional Start Date: Dec 2018 |
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Orbus Therapeutics, Inc.
Anaplastic Astrocytoma
Recurrent Anaplastic Astrocytoma
The purpose of this study is to compare the efficacy and safety of eflornithine in
combination with lomustine, compared to lomustine taken alone, in treating patients whose
anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.
expand
The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy. Type: Interventional Start Date: Jul 2016 |
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
Centre hospitalier de l'Université de Montréal (CHUM)
Acute Kidney Injury
Fluid Overload
Ultrasonography
Fluid overload is associated with adverse outcomes in patients with severe acute kidney
injury. It remains unclear if fluid overload is merely a marker of disease severity or if
organ congestion is a mediator of complications. Point-of-care ultrasound could be a modality
used... expand
Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications. The objective of this study is to determine whether ultrasound markers of organ congestion are associated with major adverse kidney events in critically ill patients with severe acute kidney injury. Type: Observational Start Date: Sep 2018 |
A Phase 3 Study With P2B001 in Subjects With Early Parkinson's
Pharma Two B Ltd.
Parkinson Disease
A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy,
Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily
Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a... expand
A Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER. Type: Interventional Start Date: Jan 2018 |
Abemaciclib and Letrozole to Treat Endometrial Cancer
Gynecologic Oncology Group
Endometrial Cancer
This is a phase II single arm trial to evaluate the objective response rate of abemaciclib
and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer.
Treatment will continue until either unacceptable toxicity, progression of disease, or
investigator/patient... expand
This is a phase II single arm trial to evaluate the objective response rate of abemaciclib and letrozole in advanced stage, persistent or recurrent endometrioid endometrial cancer. Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal. Type: Interventional Start Date: Oct 2020 |