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Wellness App for Sleep Disturbance in Hematological Cancer Patients
The University of Texas Health Science Center at San Antonio
Cancer
Sleep Disturbance
Anxiety
Depression
Inflammation
In a randomized controlled trial (RCT), the investigators will recruit participants to an
8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The
investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC)
patients... expand
In a randomized controlled trial (RCT), the investigators will recruit participants to an 8-week "app-based wellness" intervention, followed by a 12-week follow-up period. The investigators will recruit a total of 276 self-declared Chronic Hematological Cancer (CHC) patients who (representative of age, race/ethnicity, and gender) will be on stable CHC pharmacologic therapy (if any), self-identify as sleep disturbed (>5 on Pittsburgh Sleep Quality Index), do not have a sleep disorder diagnosis, do not take sleep medication/supplements >3 times per week, and are not currently practicing regular meditation. Aim 1: Test the efficacy of two app-based wellness programs (10 minutes per day) on the primary outcome of self reported sleep disturbance (Insomnia Severity Index (primary) and PROMIS Sleep Disturbance (secondary)) and secondary sleep outcomes including sleep impairment (PROMIS Sleep Impairment Scale) and sleep efficiency measured via sleep diaries and actigraphy. Aim 2: Test the efficacy of two app-based wellness programs (10 minutes per day) on inflammatory markers (i.e., TNF-a, IL-6, IL-8, CRP), fatigue, and emotional distress (i.e., anxiety, depressive symptoms measured with PROMISĀ®). Aim 3: Explore the sustained effects (i.e., 20 weeks from baseline) of two app-based wellness programs (10 minutes per day) in CHC patients. Type: Interventional Start Date: Feb 2023 |
A Study to Evaluate the Efficacy and Safety of Litifilimab (BIIB059) in Adult Participants With Active...
Biogen
Lupus Erythematosus, Systemic
The primary objective of this study is to demonstrate efficacy of litifilimab (BIIB059)
compared with placebo in participants with active systemic lupus erythematosus (SLE), who are
receiving background lupus standard of care (SOC) therapy in reducing disease activity.
The... expand
The primary objective of this study is to demonstrate efficacy of litifilimab (BIIB059) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity. The secondary objectives of this study are to demonstrate early onset of efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of litifilimab compared with placebo in reducing oral corticosteroid(s) (OCS) use; to demonstrate organ-specific efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of litifilimab compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of litifilimab compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of litifilimab compared with placebo in reducing OCS use; to assess the difference between litifilimab and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of litifilimab in participants with active SLE and to evaluate immunogenicity of litifilimab in participants with active SLE. Type: Interventional Start Date: Jul 2021 |
Trial-Ready Cohort-Down Syndrome (TRC-DS)
University of Southern California
Down Syndrome
Alzheimer Disease
Dementia
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy
adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC),
and up to 250 participants in total including co-enrolled in the Alzheimer Biomarkers
Consortium... expand
The purpose of the Trial-Ready Cohort - Down Syndrome (TRC-DS) is to enroll 120 healthy adults with Down syndrome (DS), between the ages of 25-55, into a trial ready cohort (TRC), and up to 250 participants in total including co-enrolled in the Alzheimer Biomarkers Consortium - Down Syndrome (ABC-DS) study. Participants enrolled in the TRC-DS will undergo longitudinal cognitive and clinical assessment, genetic and biomarker testing, as well as imaging and biospecimen collection. Using these outcome measures, researchers will analyze the relationships between cognitive measures and biomarkers of Alzheimer's disease (AD) to identify endpoints for AD clinical trials in DS that best reflect disease progression. To learn more about the study and participating sites, visit our study website at: https://www.trcds.org/. TRC-DS is collaborating with the Alzheimer's Disease Biomarker Consortium-Down Syndrome (ABC-DS) to allow study participants to be concurrently enrolled in both ABC-DS and TRC-DS, referred to as "co-enrollment". ABC-DS is a longitudinal, observational research study that is overseen at University of Pittsburgh Coordinating Center. ABC-DS participants who express interest in potentially joining a clinical trial in the future and who meet TRC-DS eligibility criteria, may choose to co-enroll in TRC-DS at an ABC-DS Site. Co-enrolled participants will adhere to the ABC-DS protocol and schedule of activities, but agree to share their data with the TRC-DS team and to receive invitations for future participation in clinical trials. Fore more information on ABC-DS please visit https://www.nia.nih.gov/research/abc-ds or http://abcds.pitt.edu/. Type: Observational Start Date: Jun 2021 |
Use of the CA 125 Algorithm for the Early Detection of Ovarian Cancer in Low Risk Women
M.D. Anderson Cancer Center
Ovarian Cancer
The goal of this clinical research study is to evaluate a method involving a blood test,
called CA-125, that may be helpful in the early detection of ovarian cancer in women who are
at low risk.
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The goal of this clinical research study is to evaluate a method involving a blood test, called CA-125, that may be helpful in the early detection of ovarian cancer in women who are at low risk. Type: Interventional Start Date: Jul 2001 |
A Study to Evaluate Safety and Efficacy of BIIB091 in Participants With Relapsing Forms of Multiple Sclerosis
Biogen
Relapsing Forms of Multiple Sclerosis
The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy
in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects
of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF
monotherapy... expand
The primary objectives are to investigate the safety and tolerability of BIIB091 monotherapy in participants with relapsing multiple sclerosis (RMS) (Part 1), and to evaluate the effects of BIIB091 combination therapy with Diroximel Fumarate (DRF) compared with the DRF monotherapy arm, on the key Magnetic Resonance Imaging (MRI) measure of active Central Nervous System (CNS) inflammation (Part 2). The secondary objectives are to evaluate the effects of BIIB091 monotherapy on the MRI measures of active CNS inflammation, to evaluate the effects of BIIB091 combination therapy with DRF compared with the DRF monotherapy arm on additional MRI measures of active CNS inflammation, to investigate the safety and tolerability of BIIB091 combination therapy with DRF in participants with RMS. Type: Interventional Start Date: Jul 2023 |
Metformin in Alzheimer's Dementia Prevention
Columbia University
Mild Cognitive Impairment
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting
metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early
and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55
years... expand
MAP will be a multisite phase II/III 1:1 randomized controlled trial (RCT) of long acting metformin (reduced mass Glucophage XR) vs. matching placebo in 326 men and women with early and late aMCI, without diabetes, not treated with metformin, overweight or obese, aged 55 years to 90 years. The RCT will last 18 months and have 4 visits: baseline, 6-months, 12-months, and 18-months. The RCT will be preceded by a screening phase followed by randomization and a titration period in which drug/placebo will be titrated from 500 mg a day (one tablet) to 2,000 mg a day (4 tablets), in increments of 500 mg (one tablet) every 10 days. Participants will remain in the RCT on the tolerated dose, and included in analyses on an intent to treat basis. We expect the attrition rate to be 10%/year. Neuropsychological battery, clinical interviews, physical exam, and phlebotomy will be conducted at baseline and every 6 months. Brain MRI will be conducted in approximately half of the participants (186) twice, at baseline, and after the last study visit at month 18. We will also conduct brain amyloid Positron Emission Tomography (PET) using 18F-Florbetaben, and tau PET using 18F-MK6240 in half of the participants at baseline and end of the RCT. The primary clinical outcome of the study will be changes in the Free and Cued Selective Reminding Test. The secondary clinical outcome will be changes in the Alzheimer's Disease Cooperative Study Preclinical Alzheimer's Cognitive Composite. Secondary subclinical outcomes will be changes in cortical thickness AD signature areas, changes in white matter hyperintensity volume, changes in brain amyloid burden, changes in brain tau burden, and changes in plasma biomarkers of amyloid, tau, and neurodegeneration. The data coordinating center and Imaging Core is located at John Hopkins University. The PET coordinating center is located at UC-Berkeley. The Clinical Coordinating and Monitoring Center and the central laboratory will be located at Columbia. The Research pharmacy function will be shared by the University of Rochester, which will dispense randomization kits, and the University of Iowa, which will receive bulk metformin and identical matching placebo from EMD Serono. Type: Interventional Start Date: Mar 2021 |
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With...
NRG Oncology
Metastatic Malignant Neoplasm in the Bone
Prostate Adenocarcinoma
Stage III Prostate Cancer AJCC v8
Stage IIIA Prostate Cancer AJCC v8
Stage IIIB Prostate Cancer AJCC v8
This phase III trial compares less intense hormone therapy and radiation therapy to usual
hormone therapy and radiation therapy in treating patients with high risk prostate cancer and
low gene risk score. This trial also compares more intense hormone therapy and radiation... expand
This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score. Type: Interventional Start Date: Dec 2020 |
Pragmatic Evaluation of Events And Benefits of Lipid-lowering in Older Adults
Duke University
Cognitive Impairment, Mild
Dementia
Cardiovascular Diseases
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority
study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study
conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia... expand
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events. Type: Interventional Start Date: Sep 2020 |
Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX)...
Alliance for Clinical Trials in Oncology
Locally Advanced Rectal Carcinoma
Stage II Rectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course
chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs,
such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX
(leucovorin,... expand
This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) 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. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer. Type: Interventional Start Date: Dec 2022 |
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small...
Daiichi Sankyo
Metastatic Non Small Cell Lung Cancer
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd)
in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and
platinum chemotherapy in participants with no prior therapy for advanced or metastatic
non-squamous... expand
This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Type: Interventional Start Date: Jan 2023 |
Three-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's...
Novartis Pharmaceuticals
Sjogren Syndrome
A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the
efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2)
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A randomized, double-blind, placebo controlled, 3-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-2) Type: Interventional Start Date: Aug 2022 |
ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
American Thrombosis and Hemostasis Network
Hematologic Disorder
Bleeding Disorder
Connective Tissue Disorder
Hemophilia
Thrombosis
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical
studies, the number of new therapies for all congenital and acquired hematologic conditions,
not just those for bleeding and clotting disorders, is increasing significantly. Some of the... expand
In parallel with the growth of American Thrombosis and Hemostasis Network's (ATHN) clinical studies, the number of new therapies for all congenital and acquired hematologic conditions, not just those for bleeding and clotting disorders, is increasing significantly. Some of the recently FDA-approved therapies for congenital and acquired hematologic conditions have yet to demonstrate long-term safety and effectiveness beyond the pivotal trials that led to their approval. In addition, results from well-controlled, pivotal studies often cannot be replicated once a therapy has been approved for general use.(1,2,3,4) In 2019 alone, the United States Food and Drug Administration (FDA) has issued approvals for twenty-four new therapies for congenital and acquired hematologic conditions.(5) In addition, almost 10,000 new studies for hematologic diseases are currently registered on www.clinicaltrials.gov.(6) With this increase in potential new therapies on the horizon, it is imperative that clinicians and clinical researchers in the field of non-neoplastic hematology have a uniform, secure, unbiased, and enduring method to collect long-term safety and efficacy data. ATHN Transcends is a cohort study to determine the safety, effectiveness, and practice of therapies used in the treatment of participants with congenital or acquired non-neoplastic blood disorders and connective tissue disorders with bleeding tendency. The study consists of 7 cohorts with additional study "arms" and "modules" branching off from the cohorts. The overarching objective of this longitudinal, observational study is to characterize the safety, effectiveness and practice of treatments for all people with congenital and acquired hematologic disorders in the US. As emphasized in a recently published review, accurate, uniform and quality national data collection is critical in clinical research, particularly for longitudinal cohort studies covering a lifetime of biologic risk.(7) Type: Observational Start Date: Sep 2020 |
A Study to Investigate Blinatumomab in Combination With Chemotherapy in Patients With Newly Diagnosed...
National Cancer Institute (NCI)
B Acute Lymphoblastic Leukemia
B Lymphoblastic Lymphoma
Down Syndrome
This phase III trial studies how well blinatumomab works in combination with chemotherapy in
treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or
B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as
blinatumomab,... expand
This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma with or without Down syndrome. Monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better than combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens. Type: Interventional Start Date: Jul 2019 |
The National Myelodysplastic Syndromes (MDS) Study
National Heart, Lung, and Blood Institute (NHLBI)
Myelodysplastic Syndromes (MDS)
Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic
syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap
disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be
followed... expand
Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed long term. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the study of the natural history of MDS. Type: Observational Start Date: Jun 2016 |
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319...
AbbVie
Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Follicular Lymphoma
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood
cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of
non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer
of... expand
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the recommended Phase 2 dose (RP2D) of ABBV-319 and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 114 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects. Type: Interventional Start Date: Apr 2023 |
Metabolic Mechanisms Induced by Enteral DHA and ARA Supplementation in Preterm Infants
The University of Texas Health Science Center at San Antonio
Premature
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on
lipid metabolism including the production of downstream derived mediators and how this
impacts important biological pathways such as metabolism, inflammation, and organogenic
factors.... expand
A comprehensive analysis of the impact of exogenous enteral DHA and ARA supplementation on lipid metabolism including the production of downstream derived mediators and how this impacts important biological pathways such as metabolism, inflammation, and organogenic factors. Type: Interventional Start Date: Mar 2023 |
Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
M.D. Anderson Cancer Center
Colorectal Adenocarcinoma
Stage I Colorectal Cancer AJCC v8
Stage II Colorectal Cancer AJCC v8
Stage IIA Colorectal Cancer AJCC v8
Stage IIB Colorectal Cancer AJCC v8
This study investigates if circulating tumor DNA (ctDNA) and other tumor-related
molecules/chemicals released in the blood can help doctors predict if colorectal cancer may
come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that
can be identified... expand
This study investigates if circulating tumor DNA (ctDNA) and other tumor-related molecules/chemicals released in the blood can help doctors predict if colorectal cancer may come back or spread. Tumors shed DNA and other cancer related chemicals into the blood that can be identified and studied further to provide information about the cancer. Information gathered from this study may help researchers better understand if ctDNA found in the blood can predict whether colorectal cancer may come back or spread. Type: Observational Start Date: Nov 2019 |
A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients...
National Cancer Institute (NCI)
Recurrent Low Grade Astrocytoma
Recurrent WHO Grade 2 Glioma
Refractory Low Grade Astrocytoma
Refractory Low Grade Glioma
Refractory WHO Grade 1 Glioma
This phase III trial investigates the best dose of vinblastine in combination with
selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib
alone in treating children and young adults with low-grade glioma (a common type of brain
cancer) that... expand
This phase III trial investigates the best dose of vinblastine in combination with selumetinib and the benefit of adding vinblastine to selumetinib compared to selumetinib alone in treating children and young adults with low-grade glioma (a common type of brain cancer) that has come back after prior treatment (recurrent) or does not respond to therapy (progressive). Selumetinib is a drug that works by blocking a protein that lets tumor cells grow without stopping. Vinblastine blocks cell growth by stopping cell division and may kill cancer cells. Giving selumetinib in combination with vinblastine may work better than selumetinib alone in treating recurrent or progressive low-grade glioma. Type: Interventional Start Date: Feb 2021 |
Effect of Gender Affirming Hormone Therapy on Glucose Metabolism
The University of Texas Health Science Center at San Antonio
Transgender Persons
The study will test:
1. whether estrogen treatment in transwomen is associated with improved insulin sensitivity
and beta cell function
2. whether testosterone treatment in transmen is associated with worsening insulin
sensitivity and beta cell function... expand
The study will test: 1. whether estrogen treatment in transwomen is associated with improved insulin sensitivity and beta cell function 2. whether testosterone treatment in transmen is associated with worsening insulin sensitivity and beta cell function 3. whether estrogen therapy leads to enhanced immune response in older transwormen Type: Interventional Start Date: Jun 2020 |
Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment...
National Cancer Institute (NCI)
Bladder Urothelial Carcinoma In Situ
Invasive Bladder Mixed Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating
patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus
Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different... expand
This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as 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. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone. Type: Interventional Start Date: Mar 2020 |
Clinical Procedures to Support Research in ALS
University of Miami
Amyotrophic Lateral Sclerosis
ALS-Frontotemporal Dementia
Primary Lateral Sclerosis
Progressive Muscular Atrophy
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize
information collected in the medical record to learn more about a disease called amyotrophic
lateral sclerosis (ALS) and related disorders.
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The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders. Type: Observational Start Date: Feb 2018 |
Application of L-PRF in Periodontal Surgery
The University of Texas Health Science Center at San Antonio
Periodontal Diseases
The study will compare the clinical outcomes of the two procedures, open flap debridement
(OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as
well as differences in patient postoperative pain perception.
expand
The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception. Type: Interventional Start Date: Aug 2023 |
Radiographic Changes in the Maxillary Sinus Following Closed Sinus Augmentation
The University of Texas Health Science Center at San Antonio
Dental Implant
A closed sinus augmentation is performed for dental implant placement.
expand
A closed sinus augmentation is performed for dental implant placement. Type: Interventional Start Date: Sep 2022 |
Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
Penn State University
Posttraumatic Stress Disorder
The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group
version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active
military and veteran population. The main questions it aims to answer are:
- Does AIM-CBCT... expand
The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are: - Does AIM-CBCT for PTSD improve PTSD symptoms? - Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction? Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format. Type: Interventional Start Date: Sep 2023 |
Multisite Advancement of Research on Chronic Posttraumatic Headache
The University of Texas Health Science Center at San Antonio
Posttraumatic Headache
Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain
injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for
PTH has been shown to significantly improve disability outcomes in veterans with persistent... expand
Posttraumatic headache (PTH) is a common and highly disabling consequence of traumatic brain injury (TBI) in U.S. military service members and veterans. Cognitive Behavioral Therapy for PTH has been shown to significantly improve disability outcomes in veterans with persistent PTH when delivered in-person. Telemedicine platforms can dramatically increase access to evidence-based care. However, whether CBT for PTH retains its effectiveness when delivered through a telemedicine platform has yet to be established. The purpose of this 3-arm randomized clinical trial is to compare Clinic-based Cognitive-Behavioral Therapy (CCBT) to Telemedicine-based Cognitive Behavioral Therapy (TCBT) and to treatment as usual (TAU) in 525 service members and veterans with chronic posttraumatic headaches (PTH) at 3 VA medical centers and 4 military treatment facilities across the U.S. Participants will be assessed for headache-related disability, headache experience, and psychiatric comorbidities across multiple time points. Type: Interventional Start Date: Aug 2023 |