Search Clinical Trials
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A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.
Pfizer
Respiratory Tract Infection
This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the
efficacy and safety of maternal immunization with RSVpreF against medically attended lower
respiratory tract illness (MA-LRTI) in infants.
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This randomized, double-blinded, placebo-controlled Phase 3 study is designed to evaluate the efficacy and safety of maternal immunization with RSVpreF against medically attended lower respiratory tract illness (MA-LRTI) in infants. Type: Interventional Start Date: Jun 2020 |
Safety, Tolerability, and Pharmacokinetics of MK-1654 in Infants (MK-1654-002)
Merck Sharp & Dohme Corp.
Respiratory Tract Infection
Respiratory Syncytial Virus
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
incidence of anti-drug antibodies (ADAs) of single ascending doses of MK-1654 in healthy
pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks
gestational... expand
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and incidence of anti-drug antibodies (ADAs) of single ascending doses of MK-1654 in healthy pre-term (born at 29 to 35 weeks gestational age) and full-term (born at >35 weeks gestational age) infants. Participants will be randomized into 1 of 4 dose escalation panels (Panels A to D); an additional panel (Panel E) of full-term infants will receive the same dose as Panel D. Key safety and tolerability variables will be reviewed after each dose panel prior to administering the next-highest dose. Type: Interventional Start Date: Sep 2018 |
Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy...
National Cancer Institute (NCI)
Oropharyngeal p16INK4a-Negative Squamous Cell Carcinoma
Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7
Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7
Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7
This phase II/III trial studies how well radiation therapy works when given together with
cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with
high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous
cell).... expand
This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab. Type: Interventional Start Date: Mar 2013 |
Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy)...
National Cancer Institute (NCI)
Bilateral Breast Carcinoma
HER2 Negative Breast Adenocarcinoma
Localized Breast Carcinoma
Recurrent Breast Carcinoma
Triple-Negative Breast Carcinoma
This phase Ib trial studies the best dose of berzosertib when given together with the usual
treatment (radiation therapy) in treating patients with triple negative or estrogen receptor
and/or progesterone receptor positive, HER-2 negative breast cancer. Berzosertib may stop the... expand
This phase Ib trial studies the best dose of berzosertib when given together with the usual treatment (radiation therapy) in treating patients with triple negative or estrogen receptor and/or progesterone receptor positive, HER-2 negative breast cancer. Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving M6620 and radiation therapy may kill tumor cells more effectively than radiation alone or shrink or stabilize breast cancer for longer than radiation therapy alone. Type: Interventional Start Date: Nov 2019 |
Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids...
MedtronicNeuro
Chronic Non-malignant Pain
Chronic Pain
Pain, Back
Pain, Leg
This is a prospective, multi-center, post market study to evaluate Intrathecal (IT)
preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an
alternative to systemic opioids for the treatment of chronic, intractable, non-malignant
primary back... expand
This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain. Type: Interventional Start Date: Jan 2019 |
Adaptive COVID-19 Treatment Trial 4 (ACTT-4)
National Institute of Allergy and Infectious Diseases (NIAID)
COVID-19
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone
and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are
discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For
discharged... expand
ACTT-4 will evaluate the combination of baricitinib and remdesivir compared to dexamethasone and remdesivir. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests, oropharyngeal (OP) swabs, plasma (Day 29), and serum for secondary research as well as clinical outcome data. However, if infection control or other restrictions limit the ability of the subject to return to the clinic, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary objective is to evaluate the clinical efficacy of baricitinib + remdesivir versus dexamethasone + remdesivir as assessed by the mechanical ventilation free survival by Day 29. Type: Interventional Start Date: Nov 2020 |
Early Amniotomy Following Transcervical Foley Balloon in the Induction of Labor
The University of Texas Medical Branch, Galveston
Labor Induction
Early Amniotomy
Amniotomy is commonly done in the management of labor, though there is little research
guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier
amniotomy, reporting shorter labor courses with no increase in the number of cesarean
deliveries. This... expand
Amniotomy is commonly done in the management of labor, though there is little research guiding the timing of amniotomy. Recent research largely suggests a benefit to earlier amniotomy, reporting shorter labor courses with no increase in the number of cesarean deliveries. This is some research, however, that reports an increase in cesarean deliveries with early amniotomy. Due to the small number of studies evaluating this topic, as well as the conflicting results, more research is needed. Additionally, the method of cervical ripening prior to amniotomy should be accounted for, as it may have an impact on the overall labor course. The purpose of this study is to evaluate the impact of early versus delayed amniotomy on time of delivery time from induction to the active phase of labor, as well on total time to delivery and maternal and neonatal outcomes in women undergoing cervical ripening with the Foley balloon. Type: Interventional Start Date: Oct 2020 |
Opioid Prescription After Cesarean Trial
The George Washington University Biostatistics Center
Pregnancy Related
Opioid Use
Pain
Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to
discharge to either an individualized opioid prescription protocol (IOPP) that includes
shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg.
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Non-inferiority randomized trial of 5,500 women with a cesarean delivery randomized prior to discharge to either an individualized opioid prescription protocol (IOPP) that includes shared decision making or to a fixed opioid prescription of 20 tablets of oxycodone 5mg. Type: Interventional Start Date: Sep 2020 |
Pravastatin to Prevent Preeclampsia
The George Washington University Biostatistics Center
Preeclampsia
Obstetric Labor Complications
Hypertension in Pregnancy
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to
assess whether daily treatment with pravastatin administered early in pregnancy reduces the
rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a... expand
This study is a double-blind randomized placebo-controlled trial of 1,550 high-risk women to assess whether daily treatment with pravastatin administered early in pregnancy reduces the rate of a composite outcome of preeclampsia, fetal loss and maternal death. Women with a prior history of preeclampsia with preterm delivery less than 34 weeks will be randomized to pravastatin or placebo daily until delivery. Women will have monthly study visits during pregnancy, a follow-up visit at 6 weeks postpartum and children will have follow-up visits at 2 and 5 years of age. Type: Interventional Start Date: Jul 2019 |
Environment Analysis Inside an Investigational Prescription Bottle
The University of Texas Medical Branch, Galveston
Chronic Pain
The purpose of the study is to test a research prescription bottle that will monitor the
physical environment inside the bottle.
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The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle. Type: Interventional Start Date: Dec 2018 |
Molecular Transducers of Physical Activity Consortium
University of Florida
Physical Activity
The goal of the Molecular Transducers of Physical Activity Consortium (MoTrPAC) is to assess
molecular changes that occur in response to physical activity (PA). To achieve this aim, a
mechanistic randomized controlled trial (RCT) is conducted, in which adult study participants... expand
The goal of the Molecular Transducers of Physical Activity Consortium (MoTrPAC) is to assess molecular changes that occur in response to physical activity (PA). To achieve this aim, a mechanistic randomized controlled trial (RCT) is conducted, in which adult study participants are randomized to endurance exercise (EE) training, resistance exercise (RE) training, or no exercise Control for a period of approximately 12 weeks. The overarching hypothesis is that there are discoverable molecular transducers that communicate and coordinate the effects of exercise on cells, tissues, and organs, which may initiate processes ultimately leading to the health benefits of exercise. Because this is a mechanistic trial, the main goal is not a health-related outcome. Rather, the goal is to generate a map of the molecular responses to exercise that will be used by the Consortium and by the scientific community at large to generate hypotheses for future investigations of the health benefits of PA. Type: Interventional Start Date: Aug 2019 |
Prophylactic Antibiotics After Cesarean
The University of Texas Medical Branch, Galveston
Surgical Site Infection
The purpose of this study is to determine if the addition of a 48-hour course of
post-operative antibiotics to the recommended course of pre-operative antibiotics improves
surgical site infection rate in patients who are obese and undergo Cesarean section after
laboring.... expand
The purpose of this study is to determine if the addition of a 48-hour course of post-operative antibiotics to the recommended course of pre-operative antibiotics improves surgical site infection rate in patients who are obese and undergo Cesarean section after laboring. Type: Interventional Start Date: Aug 2017 |
Postpartum Management of Hypertension in Pregnancy With Hydrochlorothiazide
The University of Texas Medical Branch, Galveston
Pre-Eclampsia
Gestational Hypertension
Superimposed Pre-Eclampsia
Hypertension, Pregnancy-Induced
Postpartum Pregnancy-Induced Hypertension
Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or
gestational hypertension.
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Postpartum prophylactic HCTZ administration for prevention and relapse of preeclampsia or gestational hypertension. Type: Interventional Start Date: Nov 2017 |
Additional Support Program Via Text Messaging and Telephone-Based Counseling for Breast Cancer Patients...
Alliance for Clinical Trials in Oncology
Anatomic Stage I Breast Cancer AJCC v8
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage III Breast Cancer AJCC v8
HER2 Negative Breast Carcinoma
Hormone Receptor Positive Breast Carcinoma
This phase III trial compares an additional support program (text message reminders and/or
telephone-based counseling) with usual care in making sure breast cancer patients take their
endocrine therapy medication as prescribed (medication adherence). Medication adherence is... expand
This phase III trial compares an additional support program (text message reminders and/or telephone-based counseling) with usual care in making sure breast cancer patients take their endocrine therapy medication as prescribed (medication adherence). Medication adherence is how well patients take the medication as prescribed by their doctors, and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed. Type: Interventional Start Date: Dec 2020 |
Plasma Adsorption in Patients With Confirmed COVID-19
Marker Therapeutics AG
Respiratory Failure
ARDS
To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol
to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients
admitted to the ICU.
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To characterize the ability of the D2000 Cartridge in combination with the Optia SPD Protocol to reduce the morbidity and mortality associated with SARS-CoV-2 infection in patients admitted to the ICU. Type: Interventional Start Date: May 2020 |
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Eli Lilly and Company
Crohn's Disease
The reason for this study is to see if the study drug mirikizumab is safe and effective in
participants with moderately to severely active Crohn's disease.
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The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease. Type: Interventional Start Date: Jul 2019 |
ACTIV-2: A Study for Outpatients With COVID-19
National Institute of Allergy and Infectious Diseases (NIAID)
Coronavirus
Covid19
Drug studies often look at the effect one or two drugs have on a medical condition, and
involve one company. There is currently an urgent need for one study to efficiently test
multiple drugs from more than one company, in people who have tested positive for COVID-19
but who... expand
Drug studies often look at the effect one or two drugs have on a medical condition, and involve one company. There is currently an urgent need for one study to efficiently test multiple drugs from more than one company, in people who have tested positive for COVID-19 but who do not currently need hospitalization. This could help prevent disease progression to more serious symptoms and complications, and spread of COVID-19 in the community. This study looks at the safety and effectiveness of different drugs in treating COVID-19 in outpatients. Participants in the study will be treated with either a study drug or with placebo. Type: Interventional Start Date: Aug 2020 |
The Impact of Sharing Audio Recorded Clinic Visits on Self-management in Older Adults
Dartmouth-Hitchcock Medical Center
Diabetes Mellitus
Hypertension
The investigators will conduct a multi-site, two-arm, parallel-group, patient-randomized,
blocked, controlled, pilot trial with a 3-month follow up in older adults (≥65 years) with
diabetes and hypertension. Participants will be randomized to receive AUDIO recordings of
their... expand
The investigators will conduct a multi-site, two-arm, parallel-group, patient-randomized, blocked, controlled, pilot trial with a 3-month follow up in older adults (≥65 years) with diabetes and hypertension. Participants will be randomized to receive AUDIO recordings of their clinic visits (AUDIO) in addition to After Visit Summary (AVS), or their AVS alone (Usual Care (UC). The investigators will recruit 90 adults (30 per site) over the targeted recruitment period of approximately 6 months. The primary outcome of interest is the feasibility of the trial and acceptability of the AUDIO intervention. The investigators will also explore the impact of AUDIO on patients' ability to self-manage care (as well as other exploratory health-related outcomes and healthcare utilization) at regular intervals from enrollment (T1 = 1 week, T2 = 3 months) compared to baseline (T0 = pre-visit) and usual care. The investigators will recruit patients from consented clinicians at three sites: Dartmouth-Hitchcock Primary Care (D-H; Manchester, NH), Vanderbilt University Medical Center (VUMC; Nashville, TN), and University of Texas Medical Branch, (UTMB; Galveston, TX). Type: Interventional Start Date: Aug 2020 |
Treatment of Bacterial Vaginosis Prior to Active Labor and Infectious Morbidity
The University of Texas Medical Branch, Galveston
Bacterial Vaginoses
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive
aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to
evaluate if the use of a single dose of metronidazole in women with BV at time of delivery... expand
Bacterial vaginosis (BV) is the most common cause of vaginal discharge among repro-ductive aged women. It is been linked to adverse maternal and neonatal outcomes. Our objective is to evaluate if the use of a single dose of metronidazole in women with BV at time of delivery reduces infectious morbidities Type: Interventional Start Date: Oct 2019 |
Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa...
Alliance for Clinical Trials in Oncology
Ductal Breast Carcinoma
Invasive Breast Carcinoma
Lobular Breast Carcinoma
Medullary Breast Carcinoma
Stage II Breast Cancer
This randomized phase III trial studies how well hypofractionated radiation therapy works in
preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter... expand
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects. Type: Interventional Start Date: Feb 2018 |
A Randomized Trial of Pessary in Singleton Pregnancies With a Short Cervix
The George Washington University Biostatistics Center
Short Cervix
Preterm Delivery
The purpose of the study is to determine whether the Arabin pessary is a useful intervention
of preterm birth at less than 37 weeks in women with a singleton gestation and a short
cervix.
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The purpose of the study is to determine whether the Arabin pessary is a useful intervention of preterm birth at less than 37 weeks in women with a singleton gestation and a short cervix. Type: Interventional Start Date: Feb 2017 |
Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for...
National Cancer Institute (NCI)
Clear Cell Renal Cell Carcinoma
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Neoplasm in the Lymph Nodes
Metastatic Malignant Neoplasm in the Soft Tissues
Metastatic Malignant Neoplasm in the Viscera
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab
followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by
nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread
to other... expand
This phase III trial compares the usual treatment (treatment with ipilimumab and nivolumab followed by nivolumab alone) to treatment with ipilimumab and nivolumab, followed by nivolumab with cabozantinib in patients with untreated renal cell carcinoma that has spread to other parts of the body. The addition of cabozantinib to the usual treatment may make it work better. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cabozantinib, 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. It is not yet known how well the combination of cabozantinib and nivolumab after initial treatment with ipilimumab and nivolumab works in treating patients with renal cell cancer that has spread to other parts of the body. Type: Interventional Start Date: May 2019 |
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
The University of Texas Medical Branch, Galveston
Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia Associated Pulmonary Hypertension
Pulmonary Hypertension
Premature Birth
Chronic Lung Disease of Prematurity
Oral L-citrulline supplementation may prevent and/or decrease the severity of chronic lung
disease associated with pulmonary hypertension in preterm infants. Since oral L-citrulline
supplementation has never been studied in preterm infants before, the side effect profile and... expand
Oral L-citrulline supplementation may prevent and/or decrease the severity of chronic lung disease associated with pulmonary hypertension in preterm infants. Since oral L-citrulline supplementation has never been studied in preterm infants before, the side effect profile and appropriate dosing are still unknown. In this pilot study, the investigators will determine the safety profile, efficacy and appropriate dosing of oral L-citrulline in preterm infants. In the future, information from this study will be utilized to conduct a randomized placebo-controlled trial to evaluate the role of L-citrulline supplementation in treating BPD_PH. Type: Interventional Start Date: Sep 2018 |
A Study of a Low-Carbohydrate Diet to Improve Maternal Health After Childbirth
The University of Texas Medical Branch, Galveston
Obesity
Postpartum Weight Retention
Insulin Sensitivity
The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese
women after having a baby. The purpose of the study is to determine if a low carbohydrate
diet is associated with improvement in insulin sensitivity in postpartum women.
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The study is evaluating the effects of a standard diet to a low carbohydrate diet in obese women after having a baby. The purpose of the study is to determine if a low carbohydrate diet is associated with improvement in insulin sensitivity in postpartum women. Type: Interventional Start Date: Dec 2019 |
Daily Versus Alternate Day Iron Supplementation for the Treatment of Iron Deficiency Anemia in Pregnancy
The University of Texas Medical Branch, Galveston
Pregnancy Related
Iron Deficiency Anemia of Pregnancy
The target population for our study is pregnant women in the first or second trimester with a
diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be
obtained by person to person contact. Eligible participants will be randomized to receive
either... expand
The target population for our study is pregnant women in the first or second trimester with a diagnosis of iron deficiency anemia. If a subject is eligible, written consent will be obtained by person to person contact. Eligible participants will be randomized to receive either daily oral iron supplementation or every other day oral iron supplementation. Type: Interventional Start Date: Oct 2020 |
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