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Clostridium Difficile Vaccine Efficacy Trial
Pfizer
Clostridium Difficile Infection
The Clover trial is evaluating an investigational vaccine that may help to prevent
Clostridium difficile infection. Participants in the study are adults 50 years of age and
older, who are at risk of developing Clostridium difficile infection. The study will assess
whether the... expand
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficile infection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection. Type: Interventional Start Date: Mar 2017 |
Starting a Testosterone and Exercise Program After Hip Injury
Washington University School of Medicine
Hip Fracture
Frailty
Sarcopenia
This study is a randomized controlled double-blinded multi-center clinical trial enrolling
female hip fracture patients who are 65 and older. It will compare the effects of six months
of supervised exercise training combined with daily topical testosterone gel, to six months... expand
This study is a randomized controlled double-blinded multi-center clinical trial enrolling female hip fracture patients who are 65 and older. It will compare the effects of six months of supervised exercise training combined with daily topical testosterone gel, to six months of supervised exercise and inactive gel, and to Enhanced Usual Care. One third of the participants will receive topical testosterone gel and a supervised exercise training program; one third will receive topical inactive gel and a supervised exercise training program; one third will receive a home exercise program. All participants will receive nutritional counseling, and calcium and vitamin D supplements. Type: Interventional Start Date: Sep 2017 |
Seqirus 2017 H7N9 With/Without MF59 (R) in Healthy Males and Non-pregnant Females, 18-64 Years of Age.
National Institute of Allergy and Infectious Diseases (NIAID)
Avian Influenza
Influenza Immunisation
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant
females, 18-64 years of age. This clinical trial is designed to assess the safety,
reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza
A/H7N9 virus vaccine... expand
This is a randomized, double-blinded, Phase II study in healthy males and non-pregnant females, 18-64 years of age. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of a pre-pandemic 2017 monovalent inactivated influenza A/H7N9 virus vaccine (2017 H7N9 IIV) manufactured by Seqirus Inc (Seqirus) administered at different dosages (3.75 microgram mcg, 7.5 mcg and 15 mcg of hemagglutinin (HA) per dose) given with MF59 (R) adjuvant manufactured by Seqirus Inc., or without adjuvant (15 mcg of HA per dose). Phosphate buffered saline (PBS) diluent manufactured by Patheon Manufacturing Services LLC will be used to achieve certain targeted doses. Approximately 371 subjects who are in good health and meet all eligibility criteria will be randomized into one of 4 study groups. The study will be conducted at up to 7 Vaccine and Treatment Unit (VTEU) sites and will last approximately 17 months, with subject participation duration of approximately 13 months. The Primary Objectives of the study are: 1) To assess the safety and reactogenicity following receipt of two doses of 2017 H7N9 IIV administered intramuscularly (IM) at different dosages approximately 21 days apart given with or without MF59 (R) adjuvant; 2) To assess the serum hemagglutinin inhibition (HAI) and neutralizing (Neut) antibody responses approximately 21 days following receipt of two doses of 2017 H7N9 IIV administered IM at different dosages approximately 21 days apart with or without MF59 (R) adjuvant. Type: Interventional Start Date: Nov 2018 |
Brain and Gut Plasticity in Mild TBI Following Growth Hormone Therapy
The University of Texas Medical Branch, Galveston
Traumatic Brain Injury
Fatigue
Cognitive Impairment
Patients with a history of mild traumatic brain injury (mTBI) and abnormal growth hormone
secretion, as measured by glucagon stimulation test, will be treated with replacement growth
hormone therapy for a period of 6 months. Testing of cognition, exercise, fatigue, brain
activation... expand
Patients with a history of mild traumatic brain injury (mTBI) and abnormal growth hormone secretion, as measured by glucagon stimulation test, will be treated with replacement growth hormone therapy for a period of 6 months. Testing of cognition, exercise, fatigue, brain activation and morphology, body composition and measurements of quality of life will be performed before and after the treatment period. Fecal sampling for characterization of the GI microbiome will occur monthly over the treatment period. Each mTBI subject will be required to enroll with an eligible control from their household that will also provide fecal samples monthly during the treatment period of their mTBI partner. GI microbiomes will be compared between mTBI patients and their household controls at baseline as well as over the treatment period. Type: Interventional Start Date: Aug 2018 |
The Effect of Growth Hormone Releasing Hormone on Cognitive Function in Individuals With Mild Cognitive...
The University of Texas Medical Branch, Galveston
Mild Cognitive Impairment
This study is examining the effects of growth hormone releasing hormone (GHRH) on mild
cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects
with MCI as well as healthy controls.
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This study is examining the effects of growth hormone releasing hormone (GHRH) on mild cognitive impairment (MCI). GHRH will be given at a dose of 1mg/day for 10 weeks to subjects with MCI as well as healthy controls. Type: Interventional Start Date: Jul 2017 |
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 |
A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
Merck Sharp & Dohme Corp.
Pneumococcal Infections
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in
healthy infants. This study will include both full-term infants (≥37 weeks gestational age)
and premature infants (<37 weeks gestational age). Premature infants will be included in a
Premature... expand
This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™. Type: Interventional Start Date: Dec 2018 |
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 age)... 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. Key safety and tolerability variables will be reviewed after each panel prior to administering the next-highest dose. Type: Interventional Start Date: Sep 2018 |
A Study to Evaluate the Interchangeability of V114 and Prevnar 13™ in Healthy Infants (V114-027/PNEU-DIRECTION)
Merck Sharp & Dohme Corp.
Pneumococcal Infections
This study is designed to evaluate the safety, tolerability, and immunogenicity of V114 and
Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the Pneumococcal
Conjugate Vaccine (PCV) immunization schedule.
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This study is designed to evaluate the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in healthy infants switched from Prevnar 13™ to V114 during the Pneumococcal Conjugate Vaccine (PCV) immunization schedule. Type: Interventional Start Date: Oct 2018 |
A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix
The George Washington University Biostatistics Center
Short Cervical Length
This protocol outlines a randomized trial of 630 women evaluating the use of micronized
vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in
women carrying twins and with a cervical length of less than 30 millimeters.
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This protocol outlines a randomized trial of 630 women evaluating the use of micronized vaginal progesterone or pessary versus control (placebo) to prevent early preterm birth in women carrying twins and with a cervical length of less than 30 millimeters. Type: Interventional Start Date: Nov 2015 |
Blood Sample Collection in Subjects With Pulmonary Nodules or CT Suspicion of Lung Cancer or Pathologically...
Exact Sciences Corporation
Lung Cancer (Diagnosis)
The primary objective of this study is to obtain de-identified, clinically characterized,
whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of
the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed
nodule... expand
The primary objective of this study is to obtain de-identified, clinically characterized, whole blood specimens for use in assessing new biomarkers for the detection of neoplasms of the lung. Subjects will be men and women, 35 years of age and older, with a CT confirmed nodule measuring 6-30 mm. Type: Observational Start Date: Apr 2016 |
Aspirin in Preventing Recurrence of Cancer in Patients With HER2 Negative Stage II-III Breast Cancer...
Alliance for Clinical Trials in Oncology
Node Positive HER2 Negative Breast Cancer
This randomized phase III trial studies how well aspirin works in preventing the cancer from
coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2)
breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that
reduces... expand
This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer. Type: Interventional Start Date: Dec 2016 |
Chronic Hypertension and Pregnancy (CHAP) Project
University of Alabama at Birmingham
Hypertension
The purpose of this study is to evaluate whether a blood pressure treatment strategy during
pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults
(<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP
is... expand
The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe. Type: Interventional Start Date: Jun 2015 |
Comparison of Axillary Lymph Node Dissection With Axillary Radiation for Patients With Node-Positive...
Alliance for Clinical Trials in Oncology
Stage II Breast Cancer
Stage IIIA Breast Cancer
This randomized phase III trial studies axillary lymph node dissection to see how well it
works compared to axillary radiation therapy in treating patients with node-positive breast
cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may
remove... expand
This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. This study will evaluate whether radiation therapy is as effective as lymph node dissection. Type: Interventional Start Date: Feb 2014 |
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in...
Merck Sharp & Dohme Corp.
Pneumococcal Infections
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114
and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal
disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when
administered... expand
This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults at increased risk for pneumococcal disease and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 6 months after receipt of either V114 or Prevnar 13™. Increased risk for pneumococcal disease is defined as 1) an underlying medical condition, 2) behavioral habits such as smoking, or 3) living in a community/environment with increased risk of disease transmission. Type: Interventional Start Date: Jul 2018 |
Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy
The George Washington University Biostatistics Center
Obstructive Sleep Apnea of Adult
Preeclampsia
Obstetrical Complications
A randomized controlled trial of 2,700 women to assess whether treatment of obstructive sleep
apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction
in the rate of hypertensive disorders of pregnancy.
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A randomized controlled trial of 2,700 women to assess whether treatment of obstructive sleep apnea with continuous positive airway pressure (CPAP) in pregnancy will result in a reduction in the rate of hypertensive disorders of pregnancy. Type: Interventional Start Date: Jul 2018 |
Safety, Tolerability, and Efficacy of the Human Cytomegalovirus Vaccine (V160) in Healthy Women 16 to...
Merck Sharp & Dohme Corp.
Cytomegalovirus Infections
This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus
(CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women
16 to 35 years of age. Participants will receive blinded V160 on Day 1, Month 2, and Month 6
(3-dose... expand
This study will evaluate the safety, tolerability, and efficacy of Human Cytomegalovirus (CMV) vaccine V160 administered in a 2-dose or 3-dose regimen in healthy seronegative women 16 to 35 years of age. Participants will receive blinded V160 on Day 1, Month 2, and Month 6 (3-dose regimen), V160 on Day 1 and Month 6 and placebo at Month 2 (2-dose regimen), or placebo on Day 1, Month 2, and Month 6, and will be followed to approximately Month 36. The primary hypothesis of the study is that administration of a 3-dose regimen of V160 will reduce the incidence of primary CMV infection compared to placebo. Type: Interventional Start Date: Apr 2018 |
Use of Sildenafil for Treatment of Urinary Incontinence
The University of Texas Medical Branch, Galveston
Urinary Incontinence
The investigators goal is to develop medical treatments for stress/mixed urinary
incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and
strength and to decrease muscle fatigue. The investigators believe that it will improve
muscular atrophy in... expand
The investigators goal is to develop medical treatments for stress/mixed urinary incontinence. Sildenafil has been shown to improve blood flow as well as muscle mass and strength and to decrease muscle fatigue. The investigators believe that it will improve muscular atrophy in the pelvic floor, thus improving symptoms of urinary incontinence related to pelvic floor dysfunction. Type: Interventional Start Date: Mar 2017 |
Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean
The George Washington University Biostatistics Center
Obstetrical Complications
Hemorrhage
Labor and Delivery
A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as
prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery.
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A randomized placebo-controlled trial of 11,000 women to assess whether tranexamic acid as prophylaxis lowers the risk of postpartum hemorrhage in women undergoing a cesarean delivery. Type: Interventional Start Date: Mar 2018 |
Validation of a Novel Screening Test for Maternal Insulin Resistance
The University of Texas Medical Branch, Galveston
Insulin Resistance, Diabetes
This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance
and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the
results of this initial trial, investigators plan to perform a larger trial at UTMB.
Quantose... expand
This will be a validation study of Quantose IR and Quantose IGT to predict insulin resistance and identify patients with prediabetes. This is a pilot study of 100 subjects. Based on the results of this initial trial, investigators plan to perform a larger trial at UTMB. Quantose IR is a fasting blood test for insulin resistance and prediabetes, and is clinically validated in non-pregnant individuals. The Quantose IR Score is based on three novel nonglycemic biomarkers, as well as insulin, and provides a comprehensive measure of insulin resistance. These analytes include: - α-HB (α-hydroxybutyrate): positively correlated with insulin resistance and indicative of early β-cell dysfunction. - L-GPC (linoleoyl-glycerophosphocholine): negatively correlated with insulin resistance and impaired glucose tolerance. - Oleic Acid: positively correlated with increasing lipolysis and insulin resistance. - Insulin: increased insulin is characteristic of insulin resistance and is an independent risk factor for type 2 diabetes and cardiovascular disease. Quantose IGT is designed to estimate the risk of being IGT. It is calculated from a multiple logistic regression model based on the fasting plasma levels of: - Glucose. - α−HB. - β−HB. - 4-methyl-2-oxopentanoic acid. - LGPC. - Oleic acid. - Serine. - Vitamin B5. Participants in the study will be consenting to data collection and two visits for lab draw. The investigators will then evaluate the performance of the Quantose IR and Quantose IGT in the study population. Type: Observational Start Date: Dec 2017 |
EMPagliflozin outcomE tRial in Patients With chrOnic heaRt Failure With Preserved Ejection Fraction (EMPEROR-Preserved)
Boehringer Ingelheim
Heart Failure
The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on
top of guideline-directed medical therapy in patients with heart failure with preserved
ejection fraction
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The aim of the study is to evaluate efficacy and safety of empagliflozin versus placebo on top of guideline-directed medical therapy in patients with heart failure with preserved ejection fraction Type: Interventional Start Date: Mar 2017 |
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 |
Pravastatin for Prevention of Preeclampsia
The University of Texas Medical Branch, Galveston
Preeclampsia
The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters
and collect preliminary safety data for pravastatin when used as a prophylactic daily
treatment in pregnant women at high risk of preeclampsia.
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The primary purpose of this pilot study is to determine the pharmacokinetic (PK) parameters and collect preliminary safety data for pravastatin when used as a prophylactic daily treatment in pregnant women at high risk of preeclampsia. Type: Interventional Start Date: Aug 2012 |
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 |
Antibacterial-coated Sutures at Time of Cesarean
The University of Texas Medical Branch, Galveston
Surgical Site Infection
Surgical Wound Infection
Cesarean Section; Infection
Cesarean Section Complications
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections
after a number of surgical procedures, but none of the previous trials included cesarean
delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces
surgical... expand
Abdominal closure with antibacterial-coated sutures has been shown to reduce wound infections after a number of surgical procedures, but none of the previous trials included cesarean delivery. Our objective is to determine whether use of antibacterial-coated sutures reduces surgical site infection (SSI) after cesarean delivery. Type: Interventional Start Date: Jan 2018 |