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Tennessee Alzheimer's Project
Aging
Alzheimer Disease
Biomarker
Cognitive Dysfunction
Mild Cognitive Impairment
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to
provide local and national researchers with access to a well-characterized and diverse
clinical cohort, including participant referrals, biosamples, clinical data, and
neuroimaging data. The VADRC Clinical Core... expand
The primary objective of the Vanderbilt Alzheimer's Disease Research Center (VADRC) is to provide local and national researchers with access to a well-characterized and diverse clinical cohort, including participant referrals, biosamples, clinical data, and neuroimaging data. The VADRC Clinical Core will create an infrastructure to support research efforts of both local and national investigator studies to develop early detection, prevention, and treatment strategies for Alzheimer's disease. The Clinical Core intends to enroll up to 1000 participants, including individuals who are cognitively unimpaired, have mild cognitive impairment, or have Alzheimer's disease. This cohort of about 1000 participants will be called the Tennessee Alzheimer's Project. Participants will be seen annually for comprehensive clinical characterization and then referred to other studies to enhance Alzheimer's disease research activities. Type: Observational Start Date: Oct 2021 |
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants...
Gastrointestinal Tract Malignancies
The purpose of this study is to evaluate the safety and preliminary clinical activity of
treatment combinations with and without chemotherapy in participants with locally
advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma.
Chemotherapy will consist of FOLFOX (oxaliplatin,... expand
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Type: Interventional Start Date: Jun 2022 |
Neural Correlates of Psychiatric Disorders
Psychiatric Disorder
Memory Disorders
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB
# 202370. The study was expanded to include stimulation and recordings approved under new
IRB #211037. The participant data originally acquired from IRB# 202370 will be included
in this new record:
This study... expand
This ClincialTrials.gov record originally corresponded to the protocol approved under IRB # 202370. The study was expanded to include stimulation and recordings approved under new IRB #211037. The participant data originally acquired from IRB# 202370 will be included in this new record: This study seeks to better understand the neural activity underlying neuro cognitive disorders. Resting state local field potential recordings will be collected from medically refractory epilepsy patients implanted with depth electrodes for seizure localization, and metrics of neural activity will be correlated with psychiatric symptoms as measured from questionnaires. Subjects will also participate in neuro cognitive tasks while neural recordings are performed, and/or receive neural stimulation through implanted depth electrodes. A better understanding of disordered neural activity underlying neuropsychiatric disorders may additionally contribute to novel methods for diagnosing, treating, and preventing these diseases. Type: Observational Start Date: Mar 2021 |
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
Heart Failure NYHA Class II
Heart Failure NYHA Class III
This is a prospective, multi-center, open label, randomized control clinical trial
evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in
NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial).
The study contains of 5 arms:
Randomized Arm - To demonstrate... expand
This is a prospective, multi-center, open label, randomized control clinical trial evaluating the safety and efficacy of the Cordella™ Pulmonary Artery Sensor System in NYHA Class II-III Heart Failure Patients (PROACTIVE-HF-2 Trial). The study contains of 5 arms: Randomized Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System in NYHA Class II HF patients. - Treatment Arm (Cohort 1) - Active Control Arm (Cohort 2) - Crossover Arm (Cohort 3) Single Arm - To demonstrate safety and efficacy of the Cordella PA Sensor System linked with a clinician-directed patient self-management strategy in NYHA Class III HF patients. - Clinician-Directed Patient Self-Management Arm (Cohort 4) - Clinician Management Arm (Cohort 5) Type: Interventional Start Date: Nov 2023 |
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult
Eosinophilic Esophagitis patients. expand
The purpose of this study is to assess the efficacy and safety of barzolvolimab in adult Eosinophilic Esophagitis patients. Type: Interventional Start Date: Jun 2023 |
Vanderbilt Memory and Aging Project
Alzheimer Disease
Aging
Aged, 80 and Over
Biomarkers
Brain
This study will use an observational cohort to cross-sectionally and longitudinally
relate vascular health to clinical, imaging, and biological markers of early Alzheimer's
disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical
covariates, we will test the hypothesis... expand
This study will use an observational cohort to cross-sectionally and longitudinally relate vascular health to clinical, imaging, and biological markers of early Alzheimer's disease and cerebrovascular disease among aging adults. Adjusting for relevant clinical covariates, we will test the hypothesis that vascular health is associated with clinical, brain magnetic resonance imaging (MRI), neuropsychological, and cerebrospinal fluid markers of early cerebrovascular and Alzheimer's disease changes (i.e., prior to the onset of significant cognitive decline or dementia). Secondarily, we will examine medical and genetic factors that might mediate associations between vascular health and brain aging, such as inflammatory processes, insulin resistance, and genetic factors (e.g., APOE, a susceptibility risk factor for dementia). Findings will advance knowledge regarding the role that vascular health plays in brain aging. Type: Observational Start Date: Sep 2012 |
Microbiome Metabolites and Alcohol in HIV to Reduce CVD RCT
Microtia
Dysbiosis
Alcohol Drinking
HIV Infections
Cardiovascular Diseases
Among people living with HIV, heavy drinking increases the risk of heart disease and
death. Studies suggest that alcohol changes the number and kind of bacteria in your gut
and these changes increase the risk of heart disease and death. This randomized
controlled trial will determine whether a pill... expand
Among people living with HIV, heavy drinking increases the risk of heart disease and death. Studies suggest that alcohol changes the number and kind of bacteria in your gut and these changes increase the risk of heart disease and death. This randomized controlled trial will determine whether a pill containing healthy gut bacteria can increase the number good bacteria in the gut, lower levels of inflammation, and lower the risk of heart disease and death. Type: Interventional Start Date: Sep 2023 |
nCCR for Chemotherapy Related Cognitive Impairment Randomized Study
Chemo-brain
Chemotherapy-Related Cognitive Impairment
The investigators propose to apply neuroplasticity-based computerized cognitive
remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). expand
The investigators propose to apply neuroplasticity-based computerized cognitive remediation (nCCR) to treat chemotherapy-related cognitive impairment (CRCI). Type: Interventional Start Date: Aug 2022 |
RA-PRO PRAGMATIC TRIAL
Rheumatoid Arthritis
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality
evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose
among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab)
or a targeted synthetic DMARD arm... expand
The 2021 ACR RA treatment guideline, based on widely acknowledged low to moderate quality evidence, recommends switching to a non-tumor necrosis factor (TNFi) biologic (choose among existing medications, currently, rituximab, abatacept, tocilizumab, or sarilumab) or a targeted synthetic DMARD arm (tsDMARD; choose among existing medications, currently, tofacitinib, baricitinib, upadacitinib) in patients with active RA despite the use of a TNFi-biologic. In practice, most patients receive another TNFi-biologic, i.e., a second TNFi-biologic first. This is not based on solid evidence, but on arbitrary algorithms often proposed by health insurance plans, and/or physician experience and habit (TNFis launched 22 yrs ago vs. the first tsDMARD 8 years ago vs. first non-TNF-biologic launched 17 years ago). This study will fill a critical knowledge gap by generating CER data for important PROs between these treatment options, switching to a non-TNFi biologic or a tsDMARD in patients with active RA despite the use of a TNFi-biologic. Type: Interventional Start Date: Sep 2021 |
Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory...
Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in
adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess
the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or
refractory large B-cell lymphoma and assess the... expand
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647. Type: Interventional Start Date: May 2020 |
The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease
HIV
Non-Alcoholic Fatty Liver Disease
Metabolic-Associated Steatotic Liver Disease
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty
liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are
not known. Changes in the intestinal microbiome may contribute to the development of
NAFLD in persons with HIV (PWH) through... expand
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH. Type: Interventional Start Date: Apr 2024 |
Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial
Osteomyelitis Tibia
Tibial Fractures
Open Tibia Fracture
This prospective randomized clinical trial will compare outcomes between patients treated
primarily with a prophylactic antibiotic coated nail and those treated with traditional
standard of care intramedullary (IM) nailing. expand
This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing. Type: Interventional Start Date: May 2023 |
PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes
Type2Diabetes
ASCVD
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare
rates of the total number of cardiovascular, kidney, and death events among two
alternative treatments for patients with type 2 diabetes (T2D) and either established
atherosclerotic cardiovascular disease (ASCVD)... expand
PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study. Type: Interventional Start Date: Sep 2022 |
PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening...
Critical Limb Ischemia
Chronic Limb-Threatening Ischemia
Peripheral Arterial Disease
A prospective, single-arm, multi-center study designed to gather additional information
on the LimFlow System. expand
A prospective, single-arm, multi-center study designed to gather additional information on the LimFlow System. Type: Interventional Start Date: Dec 2022 |
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone
(fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of
children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who
are unable to receive additional anthracyclines, or... expand
A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin [GO]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse. Type: Interventional Start Date: Oct 2022 |
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
Acute Lymphoblastic Leukemia
Acute Myelogenous Leukemia
Mixed Phenotype Acute Leukemia
Acute Leukemia
Myelodysplastic Syndromes
This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation
(HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for
peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in
children. Post-transplant cyclophosphamide... expand
This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation (HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral blood stem cell transplant in adults and bone marrow stem cell transplant in children. Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well this treatment works in patients with hematologic malignancies. Type: Interventional Start Date: Sep 2021 |
Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal...
Primary Mediastinal Large B-Cell Lymphoma
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus
chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal
B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may
help the body's immune system attack... expand
This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL. Type: Interventional Start Date: Oct 2021 |
Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable,...
Stage III Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
This phase II trial studies how well the combination of avelumab with liposomal
doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab
govitecan works in treating patients with triple negative breast cancer that is stage IV
or is not able to be removed by surgery... expand
This phase II trial studies how well the combination of avelumab with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan works in treating patients with triple negative breast cancer that is stage IV or is not able to be removed by surgery (unresectable) and has come back (recurrent). Immunotherapy with checkpoint inhibitors like avelumab require activation of the patient's immune system. This trial includes a two week induction or lead-in of medications that can stimulate the immune system. It is our hope that this induction will improve the response to immunotherapy with avelumab. One treatment, sacituzumab Govitecan, is a monoclonal antibody called sacituzumab linked to a chemotherapy drug called SN-38. Sacituzumab govitecan is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of tumor cells, known as Tumor-associated calcium signal transducer 2 (TROP2) receptors, and delivers SN-38 to kill them. Another treatment, liposomal doxorubicin, is a form of the anticancer drug doxorubicin that is contained in very tiny, fat-like particles. It may have fewer side effects and work better than doxorubicin, and may enhance factors associated with immune response. The third medication is called binimetinib, which may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth, and may help activate the immune system. It is not yet known whether giving avelumab in combination with liposomal doxorubicin with or without binimetinib, or the combination of avelumab with sacituzumab govitecan will work better in treating patients with triple negative breast cancer. Type: Interventional Start Date: Jul 2019 |
iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children
Feeding Behavior
Feeding Disorder of Infancy or Early Childhood
This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The
primary focus of the study is the evaluation of the effectiveness of treatment with
megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to
oral feedings in a pediatric population.... expand
This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. Approximately 60 pediatric subjects matching the criteria for eligibility will be enrolled in the study and randomized to receive either megestrol (n=30) or placebo (n=30). Type: Interventional Start Date: Aug 2019 |
A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction
Anterior Cruciate Ligament Tear
This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical
technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL)
that promotes reattachment and healing of the ACL using a blood-enriched implant. BEAR
will be compared to bone to patellar... expand
This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction. The BEAR technique is FDA approved and involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing an absorbable implant for the ligament ends to grow into. The investigators hypothesize that the ACL repair with BEAR technology will achieve results not appreciably worse than BPTB reconstruction, with a reduced burden of invasive surgery, when assessed over the first two post-operative years. Animal studies suggest BEAR may also ameliorate longer-term premature osteoarthritis of the knee, a common consequence of ACL reconstruction surgery. However, no human data yet support that, and this trial will conclude before such a benefit can be observed. All patients 18-55 years of age who are candidates for ACL surgery within 50 days of the ACL injury and who present to surgeons participating in the study will be offered participation in the trial. Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of knee laxity and patient reported measures at 6 months, 1 year, and 2 years. Type: Interventional Start Date: Aug 2021 |
HDClarity: a Multi-site Cerebrospinal Fluid Collection Initiative to Facilitate Therapeutic Development...
Huntington's Disease
HDClarity will seek at least 2500 research participants at different stages of
Huntington's disease (HD). The primary objective is to collect a high quality CSF sample
for evaluation of biomarkers and pathways that will enable the development of novel
treatments for HD. The secondary objective is... expand
HDClarity will seek at least 2500 research participants at different stages of Huntington's disease (HD). The primary objective is to collect a high quality CSF sample for evaluation of biomarkers and pathways that will enable the development of novel treatments for HD. The secondary objective is to generate a high quality plasma sample collection matching the CSF collections, which will also be used to evaluate biomarkers and pathways of relevance to HD research and development. Type: Observational Start Date: Jan 2017 |
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
Esophageal Stricture
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign
esophageal strictures. expand
To evaluate the safety and efficacy of the ProTractX3™ DCB for the treatment of benign esophageal strictures. Type: Interventional Start Date: Dec 2023 |
Retrieval Practice for Word Learning for Deaf and Hard of Hearing Children
Hearing Loss
Language Impairment
This study is designed to advance the promising yet underutilized research on retrieval
practice by evaluating the effectiveness and efficiency of two key retrieval practice
features (feedback and spacing). The study uses four single case adapted alternating
treatments studies, each with four 5- to... expand
This study is designed to advance the promising yet underutilized research on retrieval practice by evaluating the effectiveness and efficiency of two key retrieval practice features (feedback and spacing). The study uses four single case adapted alternating treatments studies, each with four 5- to 8-year-old children who are deaf and hard of hearing to evaluate the effects of feedback and spacing on the efficiency of word learning and retention. Type: Interventional Start Date: Feb 2023 |
FHD-286 as Monotherapy or Combination Therapy in Subjects With Advanced Hematologic Malignancies
Advanced Hematologic Malignancy
Relapsed Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Relapsed Myelodysplastic Syndromes
Refractory Myelodysplastic Syndromes
This Phase 1, multicenter, open-label, dose escalation study is designed to assess the
safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary
clinical activity of FHD-286 administered orally as monotherapy or combination therapy,
in subjects with advanced hematologic malignancies. expand
This Phase 1, multicenter, open-label, dose escalation study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of FHD-286 administered orally as monotherapy or combination therapy, in subjects with advanced hematologic malignancies. Type: Interventional Start Date: Jun 2021 |
Post-market Study of the Biodesign Hernia Graft
Ventral Hernia
The purpose of this study is to collect data on the performance of the Biodesign® Hernia
Graft when used to reinforce soft tissues during ventral hernia repair. expand
The purpose of this study is to collect data on the performance of the Biodesign® Hernia Graft when used to reinforce soft tissues during ventral hernia repair. Type: Observational Start Date: Nov 2020 |
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