
Search Clinical Trials
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9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of1
Brigham and Women's Hospital
Relapsing Multiple Sclerosis
We aim to assess the effect of Ofatumumab on microglial activation using [F-18]PBR06 PET
in MS patients in relation to changes in serum markers, MRI abnormalities and clinical
impairment longitudinally over 9 months.
Specific Aims:
Specific Aim 1: To determine the effect of Ofatumumab on microgli1 expand
We aim to assess the effect of Ofatumumab on microglial activation using [F-18]PBR06 PET in MS patients in relation to changes in serum markers, MRI abnormalities and clinical impairment longitudinally over 9 months. Specific Aims: Specific Aim 1: To determine the effect of Ofatumumab on microglial activation in MS over 9 months. Specific Aim 2: To determine the time course of effect of Ofatumumab on microglial activation and its relationship with peripheral B-cell depletion, serum neurofilament light (sNfL) chain and glial-fibrillary acid protein (GFAP) levels and other serum biomarkers Specific Aim 3: To determine the relationship of PET changes following Ofatumumab initiation with 3T MRI changes and clinical parameters. Type: Interventional Start Date: Sep 2020 |
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Long-Term Follow-up Protocol
Krystal Biotech, Inc.
Dystrophic Epidermolysis Bullosa
Recessive Dystrophic Epidermolysis Bullosa
Dominant Dystrophic Epidermolysis Bullosa
The main objective of this prospective, observational, long-term follow-up (LTFU) study
is to evaluate the long-term safety profile of the gene therapy products evaluated by
Krystal Biotech, Inc. which have a shared backbone of HSV-1, in participants who received
at least one dose of investigationa1 expand
The main objective of this prospective, observational, long-term follow-up (LTFU) study is to evaluate the long-term safety profile of the gene therapy products evaluated by Krystal Biotech, Inc. which have a shared backbone of HSV-1, in participants who received at least one dose of investigational product (IP). Type: Observational Start Date: May 2021 |
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Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure
Jon Simmons
Covid19
This Phase 2 Randomized Placebo Controlled Trial will determine if administering
nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe
and will reduce 28-day mortality. expand
This Phase 2 Randomized Placebo Controlled Trial will determine if administering nebulized Dornase Alpha (rhDNase) to COVID-19 patients with respiratory failure is safe and will reduce 28-day mortality. Type: Interventional Start Date: Apr 2020 |
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A Single Patient Compassionate Use of MBM-02 (Tempol) for the Treatment of Prostate Cancer
Matrix Biomed, Inc.
Prostate Cancer
A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for the
treatment of prostate cancer. The single patient will be exposed to orally administered
TEMPOL for up to 12 months at a maximum total daily dose of 800mg. expand
A single patient compassionate use clinical trial for the use of MBM-02 (TEMPOL) for the treatment of prostate cancer. The single patient will be exposed to orally administered TEMPOL for up to 12 months at a maximum total daily dose of 800mg. Type: Expanded Access |
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Breast Mesh Used in Two-staged Breast Reconstruction
Tianjin Medical University Cancer Institute and Hospital
Breast Cancer
Radiation
Breast Reconstruction
Synthetic Mesh
This is the first prospective randomized and controlled study on the efficacy and safety
of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The
investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will
reduce the rates of capsular contraction,1 expand
This is the first prospective randomized and controlled study on the efficacy and safety of TiLOOP® Bra mesh in patients with expander-implant breast reconstruction. The investigators hypothesize that incoporating TiLOOP Bra mesh with tissue expanders will reduce the rates of capsular contraction, improve the efficiency of expansion and provide better aesthetic result. Type: Interventional Start Date: Aug 2021 |
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Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise
Ohio State University Comprehensive Cancer Center
COVID-19
Low doses of radiation in the form of chest X-rays have been used to treat people with
pneumonia. This treatment was found to be effective by reducing inflammation and with
minimal side effects. However, it was an expensive treatment and was eventually replaced
with less costly treatments such as a1 expand
Low doses of radiation in the form of chest X-rays have been used to treat people with pneumonia. This treatment was found to be effective by reducing inflammation and with minimal side effects. However, it was an expensive treatment and was eventually replaced with less costly treatments such as antibiotics. Radiation has also been shown in some animal experiments to reduce some types of inflammation. Some patients diagnosed with COVID-19 pneumonia will experience worsening disease, which can become very serious, requiring the use of a ventilator. This is caused by inflammation in the lung from the virus and the immune system. For this study, the x-ray given is called radiation therapy. Radiation therapy uses high-energy X-ray beams from a large machine to target the lungs and reduce inflammation. Usually, it is given at much higher doses to treat cancers. The purpose of this study is to find out if adding a single treatment of low-dose x-rays to the lungs might reduce the amount of inflammation in the lungs from a COVID-19 infection, which could help a patient to breathe without use of a ventilator. Type: Interventional Start Date: Jul 2020 |
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Virtual Reality During Pediatric Cast Removal
Gillette Children's Specialty Healthcare
Fractures, Bone
This study is a randomized control trial of Virtual Reality during cast removal
procedures at a pediatric tertiary care center. expand
This study is a randomized control trial of Virtual Reality during cast removal procedures at a pediatric tertiary care center. Type: Interventional Start Date: May 2019 |
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Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial
Madigan Army Medical Center
Low Back Pain
Myofascial Pain Syndrome Lower Back
Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back,
accounts for approximately 2.63 million visits in the United States, or 2.3 percent of
annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is
lost from LBP. Approximately one-third of t1 expand
Rationale: Low back pain (LBP), or myofascial pain syndrome (MPS) of the low back, accounts for approximately 2.63 million visits in the United States, or 2.3 percent of annual Emergency Department (ED) visits. An estimated 100 billion dollars per year is lost from LBP. Approximately one-third of this is direct costs. Previous studies have established the safety of trigger point injections (TPI). However, the results of these studies are highly heterogeneous regarding TPI's ability to treat pain or improve functional outcomes. The two most promising TPI studies conducted in the ED have been published in the last two years. They both suffered from a small sample size. Additionally, they suffered from a combination of limitations including: lack of randomization, inconsistent medical management, lack of a follow-up assessment, and lack of patient centered functional outcomes. These studies were both two armed and either compared standard medical management to TPI with local anesthetic or TPI with local anesthetic to TPI with Normal Saline (NS). One of these studies concluded that TPI is generally beneficial. The other concluded that TPI with NS is superior. Research Hypothesis: The investigators hypothesize that standard therapy (ST) plus TPI with 8 mL of 0.5 percent Bupivacaine is superior to ST alone or ST plus TPI with 8 mL of NS for the treatment of the pain associated with MPS of the low back. Significance: This will be the first TPI study to compare ST, to TPI with local anesthetic, and TPI with NS for LBP conducted in an ED. It will also be the first TPI study to incorporate a patient centered functional outcome and patient follow-up after discharge from an ED. TPI's are a popular treatment modality for LBP among many Emergency Medicine Providers. However, to date, there is limited evidence for or against it. The investigators are hopeful that this study will answer whether or not trigger point injections are benefiting patients and, if so, which type of TPI is most beneficial. Type: Interventional Start Date: Dec 2020 |
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Microsurfaced Grafts in Deep Burn Wounds
CellTherX
Burns
Wound Heal
This study is designed as a prospective, randomized, within subject controlled design to
evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of
acute deep-partial or full-thickness burn wounds to promote wound healing. This study
will be performed in 2 parts: Time t1 expand
This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds. Type: Interventional Start Date: Jan 2021 |
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The PRIME Study: A Randomized, Controlled, Prospective Study
Vance Thompson Vision - MT
Patient Preference
Patient Outcomes
Post-Operative Inflammation
Grade of Post-Operative Cystoid Macular Edema
Rate of Post-Operative Cystoid Macular Edema
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment
of dexamethasone intracanilicular insert compared to topical standard care steroid.
Desiged to look at patient preference comparing the insert to drops and will also look at
patient outcomes including inflammati1 expand
To investigate the outcomes of patients undergoing bilateral RLE surgery with treatment of dexamethasone intracanilicular insert compared to topical standard care steroid. Desiged to look at patient preference comparing the insert to drops and will also look at patient outcomes including inflammatin and risk of cystoid macular edema post-operatively. Type: Interventional Start Date: Sep 2020 |
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Comparison of the Short-Term Effect of Dietary Carbohydrate Restriction Versus Exogenous Ketone Sup1
University of Pennsylvania
Healthy
The purpose of this study is to test different methods of preparation that can be used
prior to a test called an FDG PET/CT scan. FDG PET/CT scans are routinely done for
evaluation of heart inflammation. Standard preparation for the scan includes a ketogenic
(high fat and low carbohydrate) diet for1 expand
The purpose of this study is to test different methods of preparation that can be used prior to a test called an FDG PET/CT scan. FDG PET/CT scans are routinely done for evaluation of heart inflammation. Standard preparation for the scan includes a ketogenic (high fat and low carbohydrate) diet for 24 hours and overnight fasting to help suppress the amount of sugar taken up in the heart muscle. However, Investigator still do not know if this preparation is the most effective method. So the Investigator, want to investigate alternative methods for decreasing the amount of sugar uptake seen in the heart during FDG PET/CT scan, thus, investigator will have participants try up to 3 different methods of preparation prior to the FDG PET/CT scans to see which type of preparation works the best. Type: Interventional Start Date: Jan 2020 |
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Local 5-Fluorouracil Injection for the Treatment of Chalazia: A Prospective, Comparative Study
University of Washington
Chalazion
Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local
injection of triamcinolone (steroid) and incision and curettage for treatment of
chalazia. expand
Local injection of 5-fluorouracil into a chalazion (stye) is as effective as local injection of triamcinolone (steroid) and incision and curettage for treatment of chalazia. Type: Interventional Start Date: Dec 2013 |
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Complementary and Alternative Care in Multiple Sclerosis
Bastyr University
Multiple Sclerosis
This is a prospective, observational study designed to describe disease progression,
symptom change, quality of life, diet and lifestyle habits, and frequency of adverse
events among patients with multiple sclerosis (MS) who use complementary and alternative
medicine (CAM). In addition to describin1 expand
This is a prospective, observational study designed to describe disease progression, symptom change, quality of life, diet and lifestyle habits, and frequency of adverse events among patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM). In addition to describing the patterns of CAM use, this study will also identify and describe the positive deviants, those individuals with the highest quality of life and least amount of disease activity. Positive deviants will be compared to controls in order to describe medication, diet, and lifestyle patterns associated with a lack of MS disease progression and high quality of life. Type: Observational Start Date: Jun 2012 |
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Prospective Study of Colon Serrated Polyps
M.D. Anderson Cancer Center
Colon Polyps
With this study, the investigators plan to review the clinical, epidemiology, pathology,
and endoscopic features of colon serrated lesions as well as outcome of endoscopic
resection of these lesions. The findings will help us define the natural history of colon
serrated lesions, develop techniques1 expand
With this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. The findings will help us define the natural history of colon serrated lesions, develop techniques for endoscopic management of patients with serrated lesions, and identity areas for improvement. The data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals. Type: Observational Start Date: Nov 2014 |
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The Collection and Storage of Umbilical Cord Blood for Transplantation
M.D. Anderson Cancer Center
Cord Blood Stem Cell Transplantation
Cord Blood Transplantation
Hematopoietic Stem Cell Transplantation
The goal of this study is to collect blood samples from the umbilical cords of newborn
babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord
Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which
is part of the CW Bill Young Cel1 expand
The goal of this study is to collect blood samples from the umbilical cords of newborn babies, as soon as they are delivered, and to place these samples in the MD Anderson Cord Blood Bank. Your sample may be included in the National Cord Blood Inventory (NCBI) which is part of the CW Bill Young Cell Transplantation Program. The NCBI is a federally-supported program to assist in the collection of cord blood. Cord blood will be made available to patients through The National Marrow Donor Program (NMDP). These samples may then be offered to MD Anderson and other institutions for patients who need a bone marrow transplant and do not have a donor. The MD Anderson Cord Blood Bank will have the rights to release cord blood units to these institutions around the world according to established bone marrow transplant donor criteria, for a fee to cover costs. Cord blood samples that are collected and then do not meet the clinical requirements for patient use may also be used at MD Anderson or other institutions either for research or for quality purposes to improve cord blood banking procedures. If not suitable for patient use or for research purposes, the cord blood unit may be thrown away. Type: Observational Start Date: Apr 2005 |
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Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as1
Corporal Michael J. Crescenz VA Medical Center
Schizophrenia
Schizoaffective Disorder
Tobacco Smoking
Tardive Dyskinesia
Parkinsonism
To test the feasibility of studying effects of smoking cessation with varenicline on
antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of
smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective
disorder patients who are actively smoki1 expand
To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation. Type: Interventional Start Date: Jan 2019 |
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Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study
University of South Florida
Atrial Fibrillation
The goal of this pilot study is to explore the efficacy of chloroquine in terminating
persistent AF and assess its potential role as a pharmacological cardioversion agent for
the management of AF. expand
The goal of this pilot study is to explore the efficacy of chloroquine in terminating persistent AF and assess its potential role as a pharmacological cardioversion agent for the management of AF. Type: Interventional Start Date: Mar 2017 |
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Augmentation of Limb Perfusion With Contrast Ultrasound
Oregon Health and Science University
Peripheral Arterial Disease
Our laboratory has discovered that ultrasound (US) imaging together with clinically
approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These
observations have been made in mice with and without peripheral artery disease (PAD), and
also in humans where high power cont1 expand
Our laboratory has discovered that ultrasound (US) imaging together with clinically approved microbubble ultrasound contrast agents can augment limb tissue perfusion. These observations have been made in mice with and without peripheral artery disease (PAD), and also in humans where high power contrast enhanced ultrasound (CEU) was used to measure perfusion but was found also to augment perfusion by almost 2-fold. The latter human studies were performed with ultrasound protocols designed for perfusion imaging and not for flow augmentation. In this study, we will measure the degree to which limb perfusion is augmented with specific therapeutic CEU settings that are still within the FDA-approved limits with regards to US power and contrast dosing. Type: Interventional Start Date: Jun 2018 |
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Prophylactic Oral Antibiotics on Sinonasal Outcomes Following Endoscopic Transsphenoidal Surgery fo1
St. Joseph's Hospital and Medical Center, Phoenix
Antibiotics
Pituitary Adenoma
To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for
pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection
(sinusitis), and helps mucosal healing in the nasal passages. expand
To find out whether oral antibiotics given after transsphenoidal endoscopic surgery for pituitary adenoma improves sinus and nasal symptoms, reduces the incidence of infection (sinusitis), and helps mucosal healing in the nasal passages. Type: Interventional Start Date: Jul 2017 |
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Y90 Radioembolization Dose Delivery and Radiation Exposure Assessment
University of Tennessee
Hepatocellular Carcinoma
Radiation Exposure
The objective of this study is to examine critical aspects of radiation exposure, dose
delivery, and systemic yttrium-90 (Y90) exposure related to the infusion of Y90
microspheres for treatment of hepatocellular carcinoma (HCC) and other metastatic liver
disease. expand
The objective of this study is to examine critical aspects of radiation exposure, dose delivery, and systemic yttrium-90 (Y90) exposure related to the infusion of Y90 microspheres for treatment of hepatocellular carcinoma (HCC) and other metastatic liver disease. Type: Interventional Start Date: Jun 2018 |
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Adoptive T Cell Immunotherapy for Advanced Melanoma Using Engineered Lymphocytes
Loyola University
Melanoma
Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene
modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI)
funded investigator initiated therapy for patients with advanced melanoma. expand
Phase I clinical trial to determine the Phase II dose of autologous TIL 1383I TCR gene modified T Cells using a retrovirus. This is a novel National Cancer Institute (NCI) funded investigator initiated therapy for patients with advanced melanoma. Type: Interventional Start Date: Feb 2015 |
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Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or St1
Gynecologic Oncology Group
Stage IIIA Ovarian Cancer
Stage IIIB Ovarian Cancer
Stage IIIC Ovarian Cancer
Stage IV Ovarian Cancer
This research study is looking at tumor tissue samples from patients who have undergone
surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of
tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor
infiltrating T cells can predic1 expand
This research study is looking at tumor tissue samples from patients who have undergone surgery for advanced stage III or stage IV ovarian epithelial cancer. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn how tumor infiltrating T cells can predict how patients will respond to treatment. Type: Observational Start Date: Sep 2004 |
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Identification Genetic, Immunologic and Microbial Markers of Hirschsprung Associated Enterocolitis1
Cedars-Sinai Medical Center
Hirschsprung Disease
Enterocolitis
To identify demographic, clinical, genetic, immunologic and/or microbial (i.e., fecal
stream characterization) risk factors that influence the likelihood of development of the
HAEC phenotype in children who carry the diagnosis of HD. The newly formed HAEC
Collaborative Research Group (HCRG) will ut1 expand
To identify demographic, clinical, genetic, immunologic and/or microbial (i.e., fecal stream characterization) risk factors that influence the likelihood of development of the HAEC phenotype in children who carry the diagnosis of HD. The newly formed HAEC Collaborative Research Group (HCRG) will utilize the 4 participating centers in the current consortia and recruit additional centers to enroll children diagnosed with Hirschsprung disease. 1a: To recruit 200 patients with Hirschsprung disease without HAEC. 1b: To recruit 200 patients with Hirschsprung disease and HAEC using standardized diagnostic criteria by collaborating with participating members of the HAEC Collaborative Research Group[1]. 1c: To collect clinical and demographic information from well-characterized HD patients both with and without HAEC. 1d: To collect samples blood for DNA for genome wide association study (GWAS) by high throughput SNP technology and mutational analysis of known HSCR genes. 1e: To collect serum samples at the time of recruitment in a subset cohort (n=50 HD only, n=50 HD + HAEC) for serological immune markers known for inflammatory bowel disease (IBD) including ANCA, ASCA, OMPC, I2, and CBir1 and any newly identified markers. 1f: To collect and store fresh fecal specimens for future evaluation by molecular methodologies to determine relative proportions of enteric microflora in a subset cohort (n=50 HD only, n=50 HD + HAEC) of children (<18 years). 1g: To establish a Centralized Data Coordinating Center for data collection, data quality and detailed data analyses (CSMC) and tissue bank (CSMC) to facilitate specimen analysis for this study. The HAEC risk factor identification will be completed by multivariate logistic regression analysis. Genetic association will be studied for each SNP in the GWAS together with all other potential risk factors. Further analysis will be carried out to evaluate multiple SNPs/genes simultaneously. Type: Observational Start Date: Feb 2010 |
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The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry
The International FOP Association
Fibrodysplasia Ossificans Progressiva (FOP)
The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry is a global,
non-interventional, voluntary database that captures demographic and disease data
directly from FOP patients and their caregivers via a secure, web-based patient portal. A
physician portal (in development) will allow p1 expand
The Fibrodysplasia Ossificans Progressiva (FOP) Connection Registry is a global, non-interventional, voluntary database that captures demographic and disease data directly from FOP patients and their caregivers via a secure, web-based patient portal. A physician portal (in development) will allow physicians to enter clinical data about their patients. The objectives are to organize the international FOP community for participation in clinical trials; to enable FOP patients worldwide to report data in a shared forum; to improve the collective understanding of FOP natural history; and to advance the understanding of FOP treatment outcomes. Type: Observational [Patient Registry] Start Date: Jul 2015 |
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Creatine for Depressed Male and Female Methamphetamine Users
Montana State University
Depression
Anxiety
Methamphetamine Dependence
- Assess the antidepressant/anxiolytic effect of creatine in male and female
methamphetamine users
- Assess creatine's effect on methamphetamine use
- Assess the safety of creatine in male methamphetamine users with depression expand
- Assess the antidepressant/anxiolytic effect of creatine in male and female methamphetamine users - Assess creatine's effect on methamphetamine use - Assess the safety of creatine in male methamphetamine users with depression Type: Interventional Start Date: Nov 2015 |