Search Clinical Trials
Sponsor Condition of Interest |
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Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE...
Nyxoah S.A.
Sleep Apnea, Obstructive
The solution offered by the Genio System to treat OSA patients with CCC using bilateral
HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies. expand
The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies. Type: Interventional Start Date: Dec 2022 |
Autologous Muscle Derived Cells Compared to Placebo for Urinary Sphincter Repair in Post-surgical Female...
Cook MyoSite
Stress Urinary Incontinence
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for
Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in
the reduction of stress incontinence episode frequency in adult female patients with
post-surgical persistent or recurrent stress... expand
This study evaluates the efficacy and safety of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; generic name: iltamiocel) compared to a placebo in the reduction of stress incontinence episode frequency in adult female patients with post-surgical persistent or recurrent stress urinary incontinence (SUI). Half of the participants will receive AMDC-USR (injections with cells) and the other half will receive placebo. Type: Interventional Start Date: Apr 2019 |
Registry Study for Radiation Therapy Outcomes
Proton Collaborative Group
Neoplasms
The purpose of this research study is to collect and analyze information from patients
being treated with various forms of radiation therapy. expand
The purpose of this research study is to collect and analyze information from patients being treated with various forms of radiation therapy. Type: Observational [Patient Registry] Start Date: Jun 2009 |
Nephrotic Syndrome Study Network
University of Michigan
Minimal Change Disease (MCD)
Membranous Nephropathy
Glomerulosclerosis, Focal Segmental
Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous
nephropathy (MN), generate an enormous individual and societal financial burden,
accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005)
at an annual cost in the US of more than... expand
Minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS), and Membranous nephropathy (MN), generate an enormous individual and societal financial burden, accounting for approximately 12% of prevalent end stage renal disease (ESRD) cases (2005) at an annual cost in the US of more than $3 billion. However, the clinical classification of these diseases is widely believed to be inadequate by the scientific community. Given the poor understanding of MCD/FSGS and MN biology, it is not surprising that the available therapies are imperfect. The therapies lack a clear biological basis, and as many families have experienced, they are often not beneficial, and in fact may be significantly toxic. Given these observations, it is essential that research be conducted that address these serious obstacles to effectively caring for patients. In response to a request for applications by the National Institutes of Health, Office of Rare Diseases (NIH, ORD) for the creation of Rare Disease Clinical Research Consortia, a number of affiliated universities joined together with The NephCure Foundation the NIDDK, the ORDR, and the University of Michigan in collaboration towards the establishment of a Nephrotic Syndrome (NS) Rare Diseases Clinical Research Consortium. Through this consortium the investigators hope to understand the fundamental biology of these rare diseases and aim to bank long-term observational data and corresponding biological specimens for researchers to access and further enrich. Type: Observational Start Date: Apr 2010 |
A Study of Suvecaltamide in Adults With Moderate to Severe Residual Tremor in Parkinson's Disease
Jazz Pharmaceuticals
Parkinson Disease
Tremor
This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing,
parallel-group, multicenter study designed to evaluate the efficacy and safety of
suvecaltamide for the treatment of moderate to severe residual tremor in adult
participants with Parkinson's disease (PD). The target population... expand
This is a 17-week double-blind, placebo-controlled, randomized, flexible-dosing, parallel-group, multicenter study designed to evaluate the efficacy and safety of suvecaltamide for the treatment of moderate to severe residual tremor in adult participants with Parkinson's disease (PD). The target population represents participants who have tremor that is not adequately controlled by PD medications and that interferes with their activities of daily living (ADL) and/or with their performance of tasks. Type: Interventional Start Date: Dec 2022 |
A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects With Genetic Confirmation...
Asklepios Biopharmaceutical, Inc.
Limb Girdle Muscular Dystrophy
Limb-Girdle Muscular Dystrophy Type 2
LGMD2I
Muscular Dystrophy
LGMD2
The purpose of this study is to evaluate the safety and tolerability of a single
intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy
type 2I/R9 (LGMD2I/R9). Participants will be treated in sequential, dose-level cohorts.
(Part 1) expand
The purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). Participants will be treated in sequential, dose-level cohorts. (Part 1) Type: Interventional Start Date: Mar 2023 |
MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments...
Pfizer
Multiple Myeloma
The purpose of this study is to determine the Recommended Phase 2 Dose and clinical
benefit of elranatamab in combination with other anti-cancer therapies in participants
with multiple myeloma. expand
The purpose of this study is to determine the Recommended Phase 2 Dose and clinical benefit of elranatamab in combination with other anti-cancer therapies in participants with multiple myeloma. Type: Interventional Start Date: Oct 2021 |
Knee Arthroplasty Activity Trial
Brigham and Women's Hospital
Knee Osteoarthritis
Total Knee Replacement
Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain
and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As
of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded
$11 billion. Growing evidence... expand
Total knee replacement (TKR) is a common and costly procedure widely used to relieve pain and improve function in patients with symptomatic advanced knee osteoarthritis (OA). As of 2013, the annual incidence of TKR was over 680,000 surgeries and annual costs exceeded $11 billion. Growing evidence suggests that while pain and functional status improve following TKR, physical activity (PA) typically does not surpass pre-TKR levels. Engagement in PA can meaningfully improve quality of life (QoL), pain, and function. Given the large investment in TKR, the effectiveness and cost-effectiveness of TKR could be substantially increased if TKR recipients became more physically active. The Knee Arthroplasty Activity Trial (KArAT) is a randomized controlled trial and participants will be randomly assigned to one of three arms. Participants across all arms will receive usual post-operative care for TKR surgery. Participants in the first arm will complete basic study activities, such as responding to surveys and attending two in-person clinic visits. Participants in the second arm will do the same and also receive a wrist-based physical activity tracker intervention. Participants in the third arm will receive a telephonic active coaching (motivational interviewing) and financial incentives (for reaching physical activity goals) (TAC(MI)+FI) based intervention, as well as a wrist-based physical activity tracker intervention. The second and third arms will be eligible to receive lottery-based financial rewards for wearing a wrist-worn activity tracker for twenty-four months during the study. Type: Interventional Start Date: Apr 2023 |
Measuring Surgical Recovery After Radical Cystectomy
M.D. Anderson Cancer Center
Bladder Cancer
The intent of this study is to establish a registry of post-surgical outcomes in patients
undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating
institutions. The goals of this initiative are to obtain a detailed baseline of multiple
patient-reported outcomes (PRO) and clinician-reported... expand
The intent of this study is to establish a registry of post-surgical outcomes in patients undergoing radical cystectomy at MD Anderson Cancer Center and the collaborating institutions. The goals of this initiative are to obtain a detailed baseline of multiple patient-reported outcomes (PRO) and clinician-reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes. Type: Observational [Patient Registry] Start Date: Apr 2015 |
NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)
NS Pharma, Inc.
Duchenne Muscular Dystrophy
This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered
by weekly IV infusion to ambulant boys aged ≥4 to <15 years with DMD due to mutations
amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02
administered once weekly.
The... expand
This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to <15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02 administered once weekly. The study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2. Type: Interventional Start Date: Feb 2024 |
Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate...
ECOG-ACRIN Cancer Research Group
Prostate Carcinoma
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI)
works in evaluating cancer stage and helping treatment planning in patients with prostate
cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding
aggressive disease. expand
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease. Type: Interventional Start Date: Feb 2019 |
A Longitudinal Observational Study of Patients Undergoing Therapy for IMISC
Target PharmaSolutions, Inc.
Atopic Dermatitis
Alopecia Areata
Hidradenitis Suppurativa
Vitiligo
Psoriasis
TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being
managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions
(IMISC) in usual clinical practice. TARGET-DERM will create a research registry of
patients with IMISC within academic and community... expand
TARGET-DERM is a longitudinal, observational study of adult and pediatric patients being managed for Atopic Dermatitis and other Immune-Mediated Inflammatory Skin Conditions (IMISC) in usual clinical practice. TARGET-DERM will create a research registry of patients with IMISC within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies. Type: Observational [Patient Registry] Start Date: Dec 2018 |
HIT-Stroke Trial 2
University of Cincinnati
Stroke
People who had a stroke at least 6 months prior and who still have difficulty with
walking will each be randomly assigned to receive either moderate or vigorous intensity
walking exercise. Both protocols will be performed individually with a physical therapist
for 45 minutes, 3x/week for 12 weeks.... expand
People who had a stroke at least 6 months prior and who still have difficulty with walking will each be randomly assigned to receive either moderate or vigorous intensity walking exercise. Both protocols will be performed individually with a physical therapist for 45 minutes, 3x/week for 12 weeks. Measures including walking function will be assessed at baseline (PRE), after 4, 8 and 12 weeks of training (12WK) and at 3-month follow up (3moPOST), by raters who are unaware of the participant randomization. Type: Interventional Start Date: Feb 2024 |
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory...
GluBio Therapeutics Inc.
Acute Myeloid Leukemia
Myelodysplastic Syndromes
Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and
expansion clinical study of GLB-001 in participants with relapsed or refractory acute
myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk
myelodysplastic syndromes (R/R HR-MDS). The... expand
Study GLB-001-01 is a first-in-human (FIH), Phase 1, open-label, dose escalation and expansion clinical study of GLB-001 in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The dose escalation part (Phase 1a) of the study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 administered orally. Approximately 24 participants (up to 42 participants) may be enrolled in Phase 1a of the study. The dose expansion part (Phase 1b) will be followed to understand the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Up to 24 participants (12 participants per dose level) may be enrolled in Phase 1b of the study. Type: Interventional Start Date: Jan 2024 |
Comparing High-Dose Cisplatin Every Three Weeks to Low-Dose Cisplatin Weekly When Combined With Radiation...
NRG Oncology
Advanced Head and Neck Squamous Cell Carcinoma
Advanced Hypopharyngeal Squamous Cell Carcinoma
Advanced Laryngeal Squamous Cell Carcinoma
Advanced Oropharyngeal Squamous Cell Carcinoma
Squamous Cell Carcinoma of Unknown Primary
This phase II/III trial compares the effect of the combination of high-dose cisplatin
every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation
therapy for the treatment of patients with locoregionally advanced head and neck cancer.
Chemotherapy drugs, such as cisplatin,... expand
This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer. Type: Interventional Start Date: Oct 2021 |
Comparing Sentinel Lymph Node (SLN) Biopsy With Standard Neck Dissection for Patients With Early-Stage...
NRG Oncology
Buccal Mucosa Squamous Cell Carcinoma
Floor of Mouth Squamous Cell Carcinoma
Gingival Squamous Cell Carcinoma
Hard Palate Squamous Cell Carcinoma
Lip Squamous Cell Carcinoma
This phase II/III trial studies how well sentinel lymph node biopsy works and compares
sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment
for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure
that removes a smaller number of lymph... expand
This phase II/III trial studies how well sentinel lymph node biopsy works and compares sentinel lymph node biopsy surgery to standard neck dissection as part of the treatment for early-stage oral cavity cancer. Sentinel lymph node biopsy surgery is a procedure that removes a smaller number of lymph nodes from your neck because it uses an imaging agent to see which lymph nodes are most likely to have cancer. Standard neck dissection, such as elective neck dissection, removes many of the lymph nodes in your neck. Using sentinel lymph node biopsy surgery may work better in treating patients with early-stage oral cavity cancer compared to standard elective neck dissection. Type: Interventional Start Date: Jul 2020 |
Switching to E-cigarettes in African-American Smokers
University of Kansas Medical Center
Smoking Reduction
The objectives of this application are to 1) compare short- and long-term harm reduction
and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in
African American (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize
factors that predict who switches... expand
The objectives of this application are to 1) compare short- and long-term harm reduction and abuse liability potential of a nicotine salt pod-based electronic cigarettes (EC) in African American (AA) exclusive EC, dual cig-EC, and exclusive cig users, 2) characterize factors that predict who switches fully, partially, or not at all, and 3) examine if harm reduction can be further enhanced by treating dual users with varenicline (VAR) to eliminate cigarette smoking. Type: Interventional Start Date: Jul 2023 |
A Randomized Multicenter Study for Isolated Skin Vasculitis
University of Pennsylvania
Primary Cutaneous Vasculitis
Cutaneous Polyarteritis Nodosa
IgA Vasculitis
Henoch-Schönlein Purpura
Multi-center sequential multiple assignment randomized trial comparing the effectiveness
of three different standard of care treatment options for patients with isolated skin
vasculitis. expand
Multi-center sequential multiple assignment randomized trial comparing the effectiveness of three different standard of care treatment options for patients with isolated skin vasculitis. Type: Interventional Start Date: Jan 2017 |
Pompe Disease Registry Protocol
Genzyme, a Sanofi Company
Glycogen Storage Disease Type II
Pompe Disease
The Pompe Registry is a global, multicenter, international, longitudinal, observational,
and voluntary program for patients with Pompe disease, designed to track the disease's
natural history and outcomes in patients, both treated and not. Data from the Registry
are also used to fulfill various global... expand
The Pompe Registry is a global, multicenter, international, longitudinal, observational, and voluntary program for patients with Pompe disease, designed to track the disease's natural history and outcomes in patients, both treated and not. Data from the Registry are also used to fulfill various global regulatory commitments, to support product development/reimbursement, and for other research and non-research related purposes. The objectives of the Registry are: - To enhance understanding of the variability, progression, identification, and natural history of Pompe disease, with the ultimate goal of better guiding and assessing therapeutic intervention. - To assist the Pompe medical community with the development of recommendations for monitoring patients, and to provide reports on patient outcomes, to optimize patient care. - To characterize the Pompe disease population. - To evaluate the long-term effectiveness of alglucosidase alfa. Type: Observational [Patient Registry] Start Date: Sep 2004 |
vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC
University of Kansas Medical Center
Liver Cancer
This trial will provide the maximum tolerated dose for radiation therapy for liver tumors
and describe the toxicity profile using the vGRID therapy technique. Based on trials
using this type of radiation in other cancers demonstrating low toxicity rates even with
very high radiation doses and high... expand
This trial will provide the maximum tolerated dose for radiation therapy for liver tumors and describe the toxicity profile using the vGRID therapy technique. Based on trials using this type of radiation in other cancers demonstrating low toxicity rates even with very high radiation doses and high efficacy, it is likely that vGRID therapy in this trial will be well tolerated and allow dose escalation beyond currently common doses for liver tumors. Type: Interventional Start Date: Feb 2023 |
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
Jun Zhang, MD, PhD
NSCLC Stage IV
NSCLC, Recurrent
This phase IV study is hoping to determine if examining the microbiome in non-small cell
lung cancer, immunotherapy naive participants can predict the effectiveness of
immunotherapy treatment as well as determine ahead of time adverse events and their
severity. In addition, the investigator will look... expand
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers. Type: Observational Start Date: Jul 2020 |
A Behavioral Activation Intervention Administered in a College Freshman Orientation Course
University of Kansas
Alcohol; Use, Problem
Stress
Binge Eating
Depression
The transition from high school to college is a developmentally sensitive period that is
high risk for escalations in alcohol use. Although risky drinking is a common problem
among freshmen, engagement in treatment services is very low. The proposed study will
test a behavioral activation intervention... expand
The transition from high school to college is a developmentally sensitive period that is high risk for escalations in alcohol use. Although risky drinking is a common problem among freshmen, engagement in treatment services is very low. The proposed study will test a behavioral activation intervention that addresses factors limiting participation in standard treatment services by targeting alcohol use indirectly, by directly addressing concerns most relevant to incoming college freshmen, and by integrating an intervention into the college curriculum. Type: Interventional Start Date: Sep 2019 |
Protocol for Women at Increased Risk of Developing Breast Cancer
Carol Fabian, MD
Breast Cancer
The overall goal of this project is to develop an integrative system of breast cancer
risk assessment based on epidemiologic and biologic risk variables, as well as to develop
or refine risk biomarkers which may be useful in predicting and monitoring response to
prevention interventions. expand
The overall goal of this project is to develop an integrative system of breast cancer risk assessment based on epidemiologic and biologic risk variables, as well as to develop or refine risk biomarkers which may be useful in predicting and monitoring response to prevention interventions. Type: Observational Start Date: Aug 1989 |
Early Feasibility Study - Transcatheter Atrial Shunt System
Edwards Lifesciences
Heart Failure
The purpose of this study is to evaluate initial clinical safety, device functionality
and effectiveness of the Edwards Transcatheter Atrial Shunt System. expand
The purpose of this study is to evaluate initial clinical safety, device functionality and effectiveness of the Edwards Transcatheter Atrial Shunt System. Type: Interventional Start Date: Jul 2018 |
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. About 510 subjects will... 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 |
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