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Sequence of Midurethral Sling Placement During Robotic Sacrocolpopexy
University of Alabama at Birmingham
Stress Incontinence Female
Pelvic Organ Prolapse
This study looks at the best time to place a midurethral sling (MUS), which is a small
piece of mesh used to treat stress urinary incontinence (SUI) (leaking urine when you
cough, laugh, or exercise). The sling is placed during a type of surgery called robotic
sacrocolpopexy (RSC). This surgery hel1 expand
This study looks at the best time to place a midurethral sling (MUS), which is a small piece of mesh used to treat stress urinary incontinence (SUI) (leaking urine when you cough, laugh, or exercise). The sling is placed during a type of surgery called robotic sacrocolpopexy (RSC). This surgery helps fix pelvic organ prolapse, when organs like the bladder or uterus drop from their normal place. Doctors can place the sling either before or after they lift and support the top of the vagina during surgery, but they aren't sure which timing works better. In this study, investigators are comparing what is the best time to place the sling, how the patient feels after surgery and if a patient's symptoms got better or worse. Type: Interventional Start Date: Jul 2025 |
Frequency of Selected Single Nucleotide Polymorphisms in Huntington Disease Gene Expansion Carriers
Hoffmann-La Roche
Huntington Disease
For participation in this epidemiological study, a single-day visit at the study site is
required. Participants will be recruited from Huntington Disease clinics, and they will
be asked to answer questions regarding their demographics, including sex, age, race and
ethnicity, and their medical and m1 expand
For participation in this epidemiological study, a single-day visit at the study site is required. Participants will be recruited from Huntington Disease clinics, and they will be asked to answer questions regarding their demographics, including sex, age, race and ethnicity, and their medical and medication history. At the end of the visit, a blood sample will be drawn to allow testing with a sequencing assay that is specifically designed for phasing single nucleotide polymorphisms (SNPs) on the wild-type Huntington (wtHTT) and mutant Huntington (mHTT) alleles. Type: Observational Start Date: Sep 2024 |
POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse1
Medstar Health Research Institute
Pelvic Organ Prolapse
Prolapse
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of
home use of the novel Reia System (RS), which includes the Reia pessary and applicator,
compared to standard pessary care (Gellhorn or ring with/without support without knob)
among women with stage II-IV pelvi1 expand
This multi-centered, randomized controlled trial will evaluate the safety and efficacy of home use of the novel Reia System (RS), which includes the Reia pessary and applicator, compared to standard pessary care (Gellhorn or ring with/without support without knob) among women with stage II-IV pelvic organ prolapse (POP). A total of 182 participants will be recruited among pessary naïve patients who are symptomatic and choose a vaginal pessary for management of their POP from study sites specializing in Urogynecology and Reconstructive Pelvic Surgery (URPS). Participants will be assigned via 1:1 randomization using computer generated numbers in permutated groups of variable block sizes to either the intervention (the Reia System, RS) or standard pessary care (SPC) stratified by site. Participation in this trial will involve a total of four visits over six months. The primary outcome measure will be satisfaction measured at the six-month time point. Secondary outcomes will include validated surveys to assess quality of life, number of self-management events, ease/difficulty of pessary insertion/removal, importance of ability to self-manage pessary, and adverse events. Specific Aims Aim 1: To compare satisfaction with pessary use and management between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 2: To assess successful fitting, number of refitting visits, number of self-management events and continued pessary use over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 3: To compare ease/difficulty of pessary use and importance of ability to self-manage, as well as quality of life over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Aim 4: To measure rates of adverse events and risk factors for adverse events over a 6-month period between subjects randomized to the Reia System and those randomized to standard of care pessary. Type: Interventional Start Date: Nov 2024 |
CGM for Management of Type 2 Diabetes in Pregnancy
University of Alabama at Birmingham
Type 2 Diabetes Mellitus (T2DM)
Pregnancy
The goal of this clinical trial is to learn if continuous glucose monitoring works better
than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in
pregnancy. It will also learn about all risk factors (biologic, personal, social) for
maternal and infant complications in type1 expand
The goal of this clinical trial is to learn if continuous glucose monitoring works better than self-monitoring of blood glucose (fingersticks) to treat type 2 diabetes in pregnancy. It will also learn about all risk factors (biologic, personal, social) for maternal and infant complications in type 2 diabetes pregnancies. The main questions it aims to answer are: 1. Does continuous glucose monitoring improve infant outcomes compared to self-monitoring of blood glucose? 2. Does continuous glucose monitoring improve maternal diabetes control and other maternal outcomes compared to self-monitoring of blood glucose? 3. What other factors increase the risk of maternal and infant complications? Participants will: 1. Use continuous glucose monitoring or self-monitoring of blood glucose to monitor blood sugar control from enrollment until delivery 2. Have blood drawn at enrollment, 24 weeks, 34 weeks and delivery to measure hemoglobin A1c levels and store blood for future analysis 3. Complete surveys about social support, environmental stressors, diabetes distress and glucose monitoring satisfaction at research visits 4. Have umbilical cord blood collected at delivery for analysis Type: Interventional Start Date: Apr 2025 |
A Study of CT-388 in Participants Who Are Overweight or Obese With Type 2 Diabetes Mellitus
Carmot Therapeutics, Inc.
Overweight or Obese
Type 2 Diabetes Mellitus (T2DM)
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group
dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high
doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM). expand
This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding study to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in participants who are overweight or obese with Type 2 diabetes mellitus (T2DM). Type: Interventional Start Date: Nov 2024 |
Minority Stress Counseling for LGBTQ+ Individuals
University of Alabama at Birmingham
Minority Stress
Lesbian, gay, bisexual, transgender, and queer+ (LGBTQ+) individuals experience a breadth
of mental health disparities. Reducing these disparities is an area of key psychological
research. Minority stress is theorized to be an underlying source of the disparities
(Meyer, 2003). Minority stress can1 expand
Lesbian, gay, bisexual, transgender, and queer+ (LGBTQ+) individuals experience a breadth of mental health disparities. Reducing these disparities is an area of key psychological research. Minority stress is theorized to be an underlying source of the disparities (Meyer, 2003). Minority stress can be conceptualized as the internalized stigma that results from experiences of social marginalization. By reducing minority stress, it is hypothesized that generalized mental illness indicators might be reduced and indicators of wellbeing increased. Type: Interventional Start Date: Jan 2025 |
Prospective Non-Interventional Study Comparing Osimertinib +/- Chemotherapy for EGFR-Mutated NSCLC1
PrECOG, LLC.
Non Small Cell Lung Cancer
Epidermal Growth Factor Receptor Gene Mutation
Stage III Lung Cancer
Stage IV Lung Cancer
The goal of the study is to collect data on patients treated outside of a clinical trial
(in routine clinical practice) with standard of care osimertinib with or without
chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer
(NSCLC) to better understand the safety1 expand
The goal of the study is to collect data on patients treated outside of a clinical trial (in routine clinical practice) with standard of care osimertinib with or without chemotherapy in Epidermal Growth Factor Receptor (EGFR)-mutant Non-Small Cell Lung Cancer (NSCLC) to better understand the safety and effectiveness of these standard of care regimens. Type: Observational [Patient Registry] Start Date: Sep 2024 |
Recruitment and Engagement in Care to Impact Practice Enhancement (RECIPE) for Sickle Cell Disease
RTI International
Sickle Cell Disease
The goal of this observational study is to help us understand more about the best ways to
help individuals living with Sickle Cell Disease (SCD) get the best care. The main
question it aims to answer is: How to find individuals unaffiliated from SCD specialist
care use three distinct pathways? Once1 expand
The goal of this observational study is to help us understand more about the best ways to help individuals living with Sickle Cell Disease (SCD) get the best care. The main question it aims to answer is: How to find individuals unaffiliated from SCD specialist care use three distinct pathways? Once unaffiliated individuals are found using the pathways, Investigators will employ linkage coordinators (trained staff) to engage these patients in care. Participants will be asked to fill out an assessment survey which will cover areas such as previous and current treatment, clinic and hospital experience, pain, and quality of life. Participants will also be given the option of participation in a 1-hour long interview how they feel about treatment for sickle cell disease including clinic experience, pain, and quality of life? Type: Observational Start Date: Jun 2023 |
Multi-Center Clean Air Randomized Controlled Trial in COPD
JHSPH Center for Clinical Trials
Chronic Obstructive Pulmonary Disease (COPD)
This is a multi-center randomized, sham-controlled clinical trial to determine the
effectiveness of an air cleaner intervention aimed at improving indoor air quality on
reducing COPD exacerbation risk and improving quality of life, functional status, rescue
medication use. expand
This is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use. Type: Interventional Start Date: May 2024 |
Establishment of an Interdisciplinary Functional Neurological Disorder (FND) Treatment Program and1
University of Alabama at Birmingham
Functional Neurological Disorder
Convulsion, Non-Epileptic
Functional Seizure
The purpose of this study is to help providers develop an interdisciplinary treatment
pathway for functional neurological disorder (FND) at University of Alabama at Birmingham
(UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational
therapy. The study will also help pr1 expand
The purpose of this study is to help providers develop an interdisciplinary treatment pathway for functional neurological disorder (FND) at University of Alabama at Birmingham (UAB), and will involve psychiatry, speech therapy, physical therapy, and occupational therapy. The study will also help providers to evaluate the treatment pathway and publish results regarding the process and outcomes. Type: Observational [Patient Registry] Start Date: Jul 2025 |
A Study to Test Whether BI 1839100 Improves Cough in People With Idiopathic Pulmonary Fibrosis or P1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and
older with progressive pulmonary fibrosis (PPF) can participate in this study. Only
people who have a chronic cough can take part. The purpose of this study is to find out
how well BI 1839100 helps reduce coug1 expand
Adults 40 years of age and older with idiopathic pulmonary fibrosis (IPF) or 18 years and older with progressive pulmonary fibrosis (PPF) can participate in this study. Only people who have a chronic cough can take part. The purpose of this study is to find out how well BI 1839100 helps reduce coughing in people with IPF or PPF. Participants who have IPF are put into 4 groups by chance. Participants in 3 groups get different doses of BI 1839100. Participants in 1 group get placebo. Placebo looks like BI 1839100 but does not contain any medicine. Participants take the treatment for 3 months. After 1 month of treatment, participants who take the highest dose will have coughing measured to find out if the medicine works. If it does not work, the study may be stopped. Participants who have IPF are in the study for slightly longer than 4 months. During this time, they visit the study site 7 times. This study will also measure the effects of BI 1839100 on coughing and lung function in a smaller group of people with PPF. During the study, coughing is measured over 24 hours about once per month using a portable device given to participants to use during the study. Participants fill in questionnaires about their coughing. Doctors also perform breathing tests that measure how well the lungs are working at the site visits. Researchers compare the results between participants who take BI 1839100 and placebo. The doctors also regularly check participants' health and take note of any unwanted effects. Type: Interventional Start Date: Aug 2024 |
A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the T1
AbbVie
Hypothyroidism
This study will evaluate the efficacy and safety of Armour Thyroid treatment compared
with synthetic T4 in subjects who have primary hypothyroidism and are currently
stabilized (i.e., in-range thyroid-stimulating hormone [TSH]) on synthetic T4 treatment.
This study will also therefore evaluate the1 expand
This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone [TSH]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy. Type: Interventional Start Date: Apr 2024 |
Refining Treatment Options for Trichomonas Vaginalis Infection: A Comparative Analysis of Metronida1
Tulane University
Trichomonas Vaginitis
Bacterial Vaginitis
This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial
comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ)
and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both
women and men. expand
This is a multi-centered, randomized, open-label, parallel, phase IV clinical trial comparing the effectiveness and cost-effectiveness of oral multi-dose metronidazole (MTZ) and oral single-dose secnidazole (SEC) for the treatment of Trichomonas vaginalis in both women and men. Type: Interventional Start Date: May 2025 |
Evaluation of Pirfenidone as a Novel Therapeutic Strategy Against Recurrent Acute Pancreatitis.
University of Alabama at Birmingham
Recurrent Acute Pancreatitis
This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in
patients with recurrent acute pancreatitis. expand
This clinical will evaluate the safety, tolerability and early efficacy of pirenidone in patients with recurrent acute pancreatitis. Type: Interventional Start Date: Jun 2024 |
A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis1
Boehringer Ingelheim
Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive
pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a
previous study with a medicine called nerandomilast or BI 1015550.
The goal of this study is to find out how well people with1 expand
This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests. Type: Interventional Start Date: Sep 2024 |
Strategy for Improving Stroke Treatment Response
Translational Sciences, Inc.
Ischemic Stroke
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding
trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal
antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. expand
SISTER is a Phase-II, prospective, randomized, placebo-controlled, blinded, dose finding trial that aims to determine the safety and preliminary efficacy of TS23, a monoclonal antibody against the alpha-2 antiplasmin (a2-AP), in acute ischemic stroke. Type: Interventional Start Date: Mar 2024 |
Describing Treatment Outcomes and Responses in Lymphoma-associated Hemophagocytic Lymphohistiocytos1
University of Alabama at Birmingham
Lymphoma
Hemophagocytic Lymphohistiocytoses
The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in
patients with lymphoma to identify possible therapeutic strategies to improve overall
survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis. expand
The purpose of the study is to describe Hemophagocytic lymphohistiocytosis (HLH) in patients with lymphoma to identify possible therapeutic strategies to improve overall survival of the patients with lymphoma associated hemophagocytic lymphohistiocytosis. Type: Observational Start Date: May 2023 |
Responding With Evidence and Access for Childhood Headaches
Children's Hospital Medical Center, Cincinnati
Headache
Headache Disorders
Headache, Migraine
Migraine
Migraine Disorders
This comparative effectiveness study will clarify current first-line preventive treatment
approaches for use by neurologists, psychologists, and primary care providers in the
context of real world care, and will demonstrate the feasibility of Cognitive Behavioral
Therapy (CBT) via telehealth for yo1 expand
This comparative effectiveness study will clarify current first-line preventive treatment approaches for use by neurologists, psychologists, and primary care providers in the context of real world care, and will demonstrate the feasibility of Cognitive Behavioral Therapy (CBT) via telehealth for youth with migraine. The focus is on applying evidence-based care and enhancing access to it. CBT via telehealth while taking a clinically-prescribed, pill-based prevention therapy (amitriptyline) will be compared to CBT via telehealth alone. Type: Interventional Start Date: Aug 2023 |
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants1
Bristol-Myers Squibb
Systemic Lupus Erythematosus
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib
compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE)
population. expand
The purpose of this study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population. Type: Interventional Start Date: Jan 2023 |
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Hoffmann-La Roche
Chronic Obstructive Pulmonary Disease (COPD)
This study will evaluate the efficacy and safety of astegolimab compared with placebo in
participants with chronic obstructive pulmonary disease (COPD) who are former or current
smokers and have a history of frequent exacerbations. expand
This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations. Type: Interventional Start Date: Dec 2022 |
Pulmonary Embolism - Thrombus Removal With Catheter-Directed Therapy
NYU Langone Health
Pulmonary Embolism
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare
catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation
alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and
right ventricular dilation. expand
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation. Type: Interventional Start Date: Jul 2023 |
First in Human Study of IMGN151 in Recurrent Gynaecological Cancers
AbbVie
Endometrial Cancer
High Grade Serous Adenocarcinoma of Ovary
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Cervical Cancer
IIMGN151-1001 is a Phase 1, first in human, open-label dose-escalation, optimization, and
expansion study designed to characterize the safety, tolerability, pharmacokinetics (PK),
immunogenicity, and preliminary antitumor activity of IMGN151 in adult participants with
recurrent endometrial cancer;1 expand
IIMGN151-1001 is a Phase 1, first in human, open-label dose-escalation, optimization, and expansion study designed to characterize the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary antitumor activity of IMGN151 in adult participants with recurrent endometrial cancer; recurrent, high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers; or recurrent cervical cancers. All participants will be, in the opinion of the investigator, appropriate for nonplatinum single-agent therapy for their next line of therapy. Type: Interventional Start Date: Jan 2023 |
Comparison of Anti-coagulation and Anti-Platelet Therapies for Intracranial Vascular Atherostenosis
University of Florida
Intracranial Arteriosclerosis
Stroke
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or
ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of
ischemic stroke, intracerebral hemorrhage, or vascular death. expand
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death. Type: Interventional Start Date: Aug 2022 |
A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies
BeiGene
B-cell Malignancy
Marginal Zone Lymphoma
Follicular Lymphoma
Non-Hodgkin Lymphoma
Waldenström Macroglobulinemia
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1
monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety
expansion of selected doses, and a Phase 2 (expansion cohorts) expand
Study consists of two main parts to explore BGB-16673 recommended dosing, a Phase 1 monotherapy dose finding comprised of monotherapy dose escalation and monotherapy safety expansion of selected doses, and a Phase 2 (expansion cohorts) Type: Interventional Start Date: Sep 2021 |
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
Yale University
Deep Venous Thrombosis
The goal of the CRETE Studies is to investigate the newly identified age-dependent
heterogeneity in the efficacy of enoxaparin in reducing the risk of central venous
catheter-associated deep venous thrombosis in critically ill children. expand
The goal of the CRETE Studies is to investigate the newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of central venous catheter-associated deep venous thrombosis in critically ill children. Type: Interventional Start Date: May 2022 |
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