Search Results (1786)
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Single-operator Digital Cholangioscopy for the Diagnosis of Malignant and Benign Biliary Strictures
Differentiation between malignant and benign biliary strictures can be challenging. Accurate differentiation of malignant biliary strictures from benign ones is crucial to guide management decisions.
While conventional tissue acquisition techniques such as brush cytology or intraductal biopsy of the biliary stricture is often performed during ERCP for tissue diagnosis, their sensitivities are suboptimal. The average sensitivities for brush cytology and intraductal biopsy were reported to be ~ 59% and ~ 63% respectively.
When the cause of a biliary stricture remains unclear despite conventional ERCP techniques for diagnosis, cholangioscopy is often performed during ERCP to clarify the diagnosis. This allows an endoscopist to obtain a visual impression (VI) and to perform targeted biopsy under direct visualization of the biliary stricture.
Recently, a digital SOC system (SpyGlass Digital System (SpyGlass DS), Boston Scientific, USA) has become available and has the potential to further improve the diagnosis of malignant and benign biliary strictures. The utility of this digital SOC in the evaluation of biliary strictures has not been well studied. We propose this study to evaluate the utility of the digital SOC during ERCP in the diagnosis of malignant and benign biliary strictures.
First Posted: October 11, 2017
Condition(s): Biliary Stricture
Intervention(s): SpyGlass DS Cholangioscopy
Enrollment (expected or actual): 40
Sponsor: Chinese University of Hong Kong
Principal Investigator: Raymond Shing Yan Tang, Clinical Professional Consultant
Completion Date (primary or actual): December 31, 2024
Atopic Dermatitis (AD) and Food Allergy
This is a prospective, single center, clinical mechanistic pilot clinical research study. Participants will not receive any investigational agent. The investigators will examine whether children with atopic dermatitis (AD) and food allergy have a different skin barrier, microbiome, epidermal transcriptome, and epidermal lipid composition than children with AD and no food allergy and non-atopic (NA) children. Participation involves a single study visit.
First Posted: May 30, 2017
Condition(s): Atopic Dermatitis (AD), Non-atopic Healthy Controls
Enrollment (expected or actual): 62
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Completion Date (primary or actual): January 31, 2018
Effect of Different Length of Time for Trainees to Attempt Cannulation on Success Rate of Selective Cannulation During hands-on ERCP Training
Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most difficult techniques in the field of GI endoscopy. It is necessary for trainees to spend enough time and perform enough cases to grasp this technique. The methods of ERCP training include hands-on teaching, training on different kinds of simulators, training on ex-vivo or live anesthetized porcine stomach models, etc. Supervised hands-on teaching is the standard method for ERCP training.
Selective cannulation is considered the most difficult and challenging part of learning ERCP. There is not an optimal time for trainees to attempt cannulation during hands-on ERCP training. The time used for attempting cannulation by trainees was 5min or 10min in several centers. In ERCP center of the investigators hospital, 15min was used for trainees to attempt cannulation for about one year. The incidence of post-ERCP pancreatitis, the major complication related to cannulation, was 4.0%, which was comparable with previous studies.
The investigators hypothesized that a longer time (15min) for trainees to attempt cannulation would increase success rate of selective cannulation and help to improve skills more quickly. At the meantime, with actively verbal or hands-on assistance from the instructor during performance of trainees, the risk of complications would not increased with a longer time to attempt cannulation. Here a prospective, endoscopists-blinded, randomized, controlled study was designed to evaluate the effects of different periods of time for trainees to attempt selective cannulation on success rate of cannulation, self-satisfaction of performance and post-ERCP pancreatitis.
First Posted: May 10, 2013
Condition(s): Disease as Reason for ERCP
Intervention(s): Hands-on ERCP training.
Enrollment (expected or actual): 256
Sponsor: Air Force Military Medical University, China
Principal Investigator: Yanglin Pan, Associated professor
Completion Date (primary or actual): December 2013
Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke
This study explores the effects of telerehabilitation and a study medication on rehabilitation outcomes in patients with stroke resulting in arm weakness. Patients with arm weakness due to a stroke that happened in the past 30 days will be randomized into one of three groups:  TR and placebo (a sugar pill) on top of usual care;  TR and a medication (Sinemet 25/100) on top of usual care;  or usual care alone (no TR and no pill, but people in this group will be offered TR once the study is done). TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.
First Posted: May 11, 2022
Intervention(s): Telerehabilitation, Sinemet Pill, Placebo
Enrollment (expected or actual): 72
Sponsor: University of California, Los Angeles
Principal Investigator: Steven C. Cramer, MD, FAAN, FAHA, Professor
Completion Date (primary or actual): April 2025
Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's Disease
In patients with Parkinson's disease, the characteristic motor symptoms, i.e., slowness of movement (bradykinesia), tremor and rigidity, are consequences of the progressive degeneration of neurons containing and releasing dopamine. The first-line treatment of Parkinson´s is oral administration of levodopa - a precursor to dopamine that (unlike dopamine) passes the blood brain barrier. After the first few years of treatment with levodopa, many patients do however develop a highly variable response to the drug characterised by rapid shifts between impaired locomotion and drug induced dyskinesias (referred to as the on-off syndrome). This is cased by the marked variation in serum levodopa levels following per oral administration, and it is known that intravenous administration of levodopa give a more stable level of levodopa with improved on-off symptoms.
Levodopa-carbidopa intestinal gel (LCIG) - under the name of Duodopa® - is delivered directly to the proximal jejunum via a tube connected to a portable infusion pump. Infusion of Duodopa in the jejunum bypasses gastric emptying, helping to avoid the fluctuation in plasma levodopa levels. However, while clearly confirming that an even administration of levodopa is of considerable benefit to Parkinson patients with on-off symptomatology, the LCIG approach is marred by the need for surgery (for the insertion of the intestinal tube) and various possible complications following this, as well as by side effects such as abdominal pain.
Researchers have now succeeded in producing a physiologically acceptable levodopa solution (called Infudopa) in a concentration allowing for a continuous intravenous (i.v.) or subcutaneous (s.c.) administration of therapeutic doses to humans. Early experience of this strategy confirms that both s.c. and i.v. administration of this solution results in even serum levodopa levels and markedly improved motor functioning. The aim of this study is to compare the pharmacokinetic profile of Infudopa administered i.v. and s.c. with that of Duodopa administered enterally in parkinsonian patients with on-off complications.
First Posted: February 5, 2018
Condition(s): Parkinson Disease
Intervention(s): Infudopa i.v., Infudopa s.c., LCIG (Duodopa)
Enrollment (expected or actual): 25
Sponsor: Vastra Gotaland Region
Completion Date (primary or actual): March 27, 2020
Common Noradrenergic Mechanisms in Parkinson´s Disease and L-DOPA Induced Dyskinesia
The aims of this proposal include tests of hypotheses of the pathogenetic mechanisms of noradrenergic neurotransmission in Parkinson's disease in vivo, using positron emission tomography of patients with early and advanced Parkinson's disease with or without 3,4 L-dihydroxyphenylalanine (L-DOPA) - induced dyskinesia or co-morbid depression, and evaluation of whether these mechanisms can be influenced therapeutically.
The investigators argue that release in human cortical and subcortical brain regions of norepinephrine (NE) derived from metabolism of exogenousL-DOPA is greater in Parkinson's disease patients with L-DOPA- induced dyskinesia than in patients without this complication. This hypothesis will be tested by measuring antagonist [11C]yohimbine binding to alpha-2 adrenoceptors before and after L-DOPA challenge.
If so, it is argued that the greater rise of norepinephrine, measured as [11C]yohimbine displacement after L-DOPA challenge, is the result of down-regulation or loss of norepinephrine transporters. This hypothesis will be tested by measuring the binding of [11C]MeNER, a tracer of norepinephrine transporters.
If so, the investigators argue that the greater decline of [11C]MeNER binding is significantly correlated to the symptoms of Parkinson's disease, as proof that patients with more severe loss of noradrenergic terminals exhibit more severe motor deficits.
First Posted: October 19, 2015
Condition(s): Parkinson´s Disease
Enrollment (expected or actual): 45
Sponsor: Aarhus University Hospital
Principal Investigator: Adjmal Nahimi, MD, PhD
Completion Date (primary or actual): January 2016
A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects
A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.
First Posted: November 6, 2019
Condition(s): Chronic Pain, Nociceptive Pain, Pain
Intervention(s): CNTX-6016, Other: Placebo
Enrollment (expected or actual): 68
Sponsor: Centrexion Therapeutics
Completion Date (primary or actual): August 21, 2019
Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease Patients
The goal of this multicentric prospective randomized controlled clinical and economic study is to investigate the effectiveness and cost-utility of long-term continuous intraduodenal infusion of levodopa ( DUODOPA), compared to best medical treatment, on advanced and severe form of Parkinson's disease.
First Posted: February 8, 2011
Condition(s): Parkinson's Disease
Intervention(s): Duodopa, best médical treatment
Enrollment (expected or actual): 56
Sponsor: Poitiers University Hospital
Completion Date (primary or actual): March 2016
Bioavailability and Metabolism of Avenanthramide: a Novel Oat Phytochemical
The purpose of the study is to examine whether orally ingested oat avenanthramides (AVA) in oat flour cookies are bioavailable in humans by measuring plasma and urine concentrations of AVAs and their potential metabolites after ingestion. The blood and urine concentrations will be quantified at several different time points after the oat flour cookies are consumed to characterize the "concentration-time profile".
First Posted: April 14, 2015
Condition(s): Bioavailability, Metabolism, Avenanthramides
Enrollment (expected or actual): 16
Sponsor: PepsiCo Global R&D
Completion Date (primary or actual): July 15, 2015
Sleepiness in Parkinson's Patients With Continuous Dopaminergic Delivery Device or Deep Brain Stimulation
Sleepiness is frequent in parkinsonian patients, increasing with the duration of disease. By patients with motor fluctuations, continuous dopaminergic delivery devices or deep brain stimulation are justified to improve the motor prognosis. Antiparkinsonian treatments, especially dopaminergic agonists, may worsen the sleepiness and thus affect the quality of life. The investigators aimed to monitor sleepiness in parkinsonian patients before and during treatment with continous dopaminergic delivery device or deep brain stimulation.
First Posted: June 22, 2020
Condition(s): Parkinson Disease
Intervention(s): Multiple sleep latency tests
Enrollment (expected or actual): 30
Sponsor: Central Hospital, Nancy, France
Completion Date (primary or actual): June 2023
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Participants With Parkinson's Disease (PD)
The purpose of this study is to assess the safety and tolerability of ABBV-951 in participants with Parkinson's disease (PD).
First Posted: December 19, 2018
Condition(s): Parkinson's Disease (PD)
Enrollment (expected or actual): 244
Completion Date (primary or actual): August 17, 2022
A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's Disease
To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a single dose of Parcopa or Sinemet are being compared in 10 subjects with Parkinson's disease. Subjects 40 years or older having idiopathic PD with Hoehn and Yahr state II or III are eligible if taking a stable dose of < 200 mg carbidopa and < 2000 mg levodopa daily. At both treatment visits, either Parcopa or Sinemet, plus a placebo of the opposite tablet (ODT or conventional) are administered. The dose is the same as the subject's prestudy regimen. The primary efficacy variable, time to onset of action, is the first postdose time when a 30% decrease (30% improvement) in the total score is achieved. All UPDRS evaluations are done by a rater blinded to the active treatment received by the subject.
First Posted: August 31, 2005
Condition(s): Parkinson's Disease
Enrollment (expected or actual):
Sponsor: UCB Pharma
Completion Date (primary or actual): August 2005
Study for the Early Diagnosis of Parkinson's Disease
The main objective of the study is to design and validate the blood based PDx gene expression and miRNA assay for the early diagnosis of Parkinson's disease patients. Differential diagnosis includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.
First Posted: November 5, 2014
Condition(s): Parkinson's Disease, Idiopathic
Status: Active, not recruiting
Enrollment (expected or actual): 410
Sponsor: Bio Shai Ltd.
Completion Date (primary or actual): December 2019
Relation Between Pregnenolone Endocannabinoids in Normal-weight and Obese Men
Measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and CB1 ligand in obese subjects. This dysfunction could participate to the hyperactivity of endocannabinoid system saw in obesity.
First Posted: May 17, 2017
Intervention(s): Obese men, Normal-weight men
Enrollment (expected or actual): 25
Sponsor: University Hospital, Bordeaux
Completion Date (primary or actual): November 2, 2017
Neurobiological Principles Applied to the Rehabilitation of Stroke Patients
The purpose of this study is to use (Transcranial Magnetic Stimulation) TMS or drugs to improve learning of movement skills and the adaptation processes in patients after stroke. Once investigators have determined the improving effect of TMS and the drugs on learning of movement skills, the study team may be able to provide information that improves rehabilitative treatment and helps to improve recovery after stroke.
First Posted: July 15, 2008
Intervention(s): Transcranial Magnetic Stimulation (TMS), Carbidopa-Levodopa, Methylphenidate, Amphetamine Sulfate, Placebo, Sham Transcranial Magnetic Stimulation (TMS), Transcranial Magnetic Stimulation (TMS) Training
Enrollment (expected or actual): 33
Sponsor: Emory University
Principal Investigator: Cathrin Buetefisch, Dr. Cathrin Buetefisch
Completion Date (primary or actual): September 2016
Alefacept and Allogeneic Hematopoietic Stem Cell Transplantation
Allogeneic blood and marrow transplantation remains the only viable cure for children who suffer from many serious non-malignant hematological diseases. Transplantation, however, carries a high risk of fatal complications. Much of the risk stems from the use of high dose radiation and chemotherapy for conditioning, the treatment administered just prior to transplant that eliminates the patients' marrow and immune system, effectively preventing rejection of the donors' cells. Attempts to make blood and marrow transplantation safer for children with non-malignant diseases by using lower doses of radiation and chemotherapy have largely failed because of a high rate of graft rejection.
In many such cases, it is likely that the graft is rejected because the recipient is sensitized to proteins on donor cells, including bone marrow cells, by blood transfusions. The formation of memory immune cells is a hallmark of sensitization, and these memory cells are relatively insensitive to chemotherapy and radiation. Alefacept, a drug used to treat psoriasis, on the other hand, selectively depletes these cells. The investigators are conducting a pilot study to begin to determine whether incorporating alefacept into a low dose conditioning regimen can effectively mitigate sensitization and, thereby, prevent rejection of allogeneic blood and marrow transplants for multiply transfused children with non-malignant hematological diseases.
First Posted: March 22, 2011
Condition(s): Thalassemia, Sickle Cell Disease, Glanzmann Thrombasthenia, Wiskott-Aldrich Syndrome, Chronic-granulomatous Disease, Severe Congenital Neutropenia, Leukocyte Adhesion Deficiency, Schwachman-Diamond Syndrome, Diamond-Blackfan Anemia, Fanconi Anemia, Dyskeratosis-congenita, Chediak-Higashi Syndrome, Severe Aplastic Anemia
Enrollment (expected or actual): 3
Sponsor: Emory University
Principal Investigator: John Horan, Associate Professor
Completion Date (primary or actual): September 2013
Misfolded Proteins in the Skin of People With Parkinson's Disease and Other Parkinsonism
The purpose of this study is to determine whether identification of misfolded proteins in the skin will help to determine what sort of parkinsonism someone has. We seek to demonstrate whether someone has a synucleinopathy such as Parkinson's disease (PD), multiple system atrophy (MSA), or dementia with Lewy bodies(DLB), as opposed to a tauopathy such as progressive supranuclear palsy (PSP) or corticobasal degeneration (CBD) or no parkinsonism at all (control).
First Posted: August 19, 2020
Condition(s): Parkinson Disease, Parkinsonism, Dementia With Lewy Bodies, Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration
Intervention(s): punch skin biopsy
Enrollment (expected or actual): 250
Sponsor: University Hospitals Cleveland Medical Center
Principal Investigator: Steven Gunzler, MD, Assistant Professor, Neurology
Completion Date (primary or actual): May 31, 2024
Neuromolecular Risk Factors for Obesity (PROSPECT)
The goal of this project is to characterize the neural and psychological mechanisms that contribute to development of obesity in the early adulthood. We address the neuromolecular risk factors for obesity using multi-modal molecular (positron emission tomography with) and functional (functional magnetic resonance imaging) neuroimaging in a prospective design. Normal weight adolescents with high versus low familial, genetic and psychological risk factors for obesity will be studied and followed for five years.
First Posted: April 10, 2017
Intervention(s): fMRI imaging, [11C]carfentanil PET scan, [18F]FMPEP-d2 PET scan, [18F]-FDG PET scan, Physical activity measures and fitness tests, Laboratory measurements, Questionnaires, Hyperinsulinemic euglycemic clamp
Status: Active, not recruiting
Enrollment (expected or actual): 60
Sponsor: Turku University Hospital
Principal Investigator: Pirjo Nuutila, Professor
Completion Date (primary or actual): December 1, 2022
Curcumin on NFE2L2 Gene Expression, Antioxidant Capacity and Renal Function According to rs35652124 in Diabetic Nephropathy
The increase in the prevalence of diabetes mellitus (DM) is one of the greatest public health challenges worldwide. Epidemiological studies have shown that DM is the leading cause of chronic kidney disease (CKD) in patients initiating renal replacement therapy. In our country, diabetes accounts for about 60% of all incidents of dialysis. On the other hand, CKD is currently considered a noxious disease because patients not only have the likelihood of progression to end-stage renal disease (ESRD), but because these renal alterations are associated with an increased risk of cardiovascular complications and premature death for the same cause. Most studies have focused on traditional risk factors (poor diet, physical inactivity and obesity) for the development and progression of renal damage, and less information exists on non-traditional factors such as oxidative stress and mainly, the low antioxidant response that characterizes both DM and nephropathy. In addition, there is a great variation in the susceptibility to and progression of kidney disease between different populations that is not explained by the presence of traditional factors and that could be triggered by genetic variations and its interaction with other components related to the environment and lifestyle. Fortunately, there is sufficient scientific evidence that early detection and modification of negative lifestyle factors can not only delay or halt the progression of the renal function decline to ESRD but can also significantly reduce the incidence of cardiovascular disease leading to premature death in most of these patients. Therefore, it is suggested that this risk may be determined by the interaction of lifestyle factors with the presence of susceptibility alleles, which may vary from one population to another. It is now known that hyperglycemia causes a state of oxidative stress and inflammation that can be counteracted by diet supplementation with some natural antioxidants such as curcumin. It has been shown that this molecule has multiple pharmacological properties: antioxidant, anti-inflammatory, cardioprotective, renoprotective, among others. In clinical trials a positive effect of curcumin has been seen in the treatment of diabetes and its complications. This has generated a relative optimism in the search for new curcumin treatment targets where oxidative stress is of great relevance, as is the case with CKD. However, there are still doubts about its efficacy as an adjuvant in the prevention of CKD. Additionally, the role played by interindividual variability in genes involved in the mechanism of action of curcumin is still incipient, more studies in this knowledge area are necessary.
First Posted: August 25, 2017
Condition(s): Chronic Kidney Diseases, Diabetes Mellitus, Type 2, Polymorphism
Intervention(s): Curcumin/NFE2L2 A>G, Placebo/NFE2L2 A>G
Status: Not yet recruiting
Enrollment (expected or actual): 176
Sponsor: Unidad de Investigacion Medica en Enfermedades Renales
Completion Date (primary or actual): February 28, 2019
Unrelated Hematopoietic Stem Cell Transplantation(HSCT) for Genetic Diseases of Blood Cells
This is a clinical trial of bone marrow transplantation for patients with the diagnosis of a genetic disease of blood cells that do not have an HLA-matched sibling donor. Genetic diseases of blood cell include: Red blood cell defects e.g. hemoglobinopathies (sickle cell disease and thalassemia), Blackfan-Diamond anemia and congenital or chronic hemolytic anemias; White blood cells defects/immune deficiencies e.g. chronic granulomatous disease, Wiskott-Aldrich syndrome,Osteopetrosis, Kostmann's syndrome (congenital neutropenia), Hereditary Lymphohistiocytosis (HLH); Platelets defects e.g.Congenital amegakaryocytic thrombocytopenia; Metabolic/storage disorders e.g. leukodystrophies,mucopolysaccharidoses as Hurler disease;Stem cell defects e.g.reticular agenesis, among many other rare similar conditions.
The study treatment plan uses a new transplant treatment regimen that aims to try to decrease the acute toxicities and complications associated with the standard treatment plans and to improve outcome
The blood stem cells will be derived from either unrelated donor or unrelated umbilical cord blood.
First Posted: August 8, 2008
Condition(s): Sickle Cell Disease, Thalassemia, Anemia, Granuloma, Wiskott-Aldrich Syndrome, Chediak Higashi Syndrome, Osteopetrosis, Neutropenia, Thrombocytopenia, Hurler Disease, Niemann-Pick Disease, Fucosidosis
Intervention(s): Hematopoietic stem cell transplantation
Enrollment (expected or actual): 25
Sponsor: Children's Hospital Los Angeles
Principal Investigator: Hisham Abdel-Azim, Principle Investigator
Completion Date (primary or actual): August 2015
Rapid Infusion of Immune Globulin Intravenous (Human) In Primary Immunodeficiency Patients
The objective of this study is to determine if the safety and tolerability of Immune Globulin Intravenous (Human), 10% caprylate/chromatography (IGIV-C)purified is similar when infused at two different infusion rates. The primary objective is to compare the incidence and severity of all infusion related adverse events when IGIV-C, 10% is administered at a rate of 0.14 mL/kg/min compared to a rate of 0.08 mL/kg/min after a single daily infusion.
First Posted: September 22, 2005
Condition(s): Immunologic Deficiency Syndrome, Agammaglobulinemia, Severe Combined Immunodeficiency, Wiskott-Aldrich Syndrome, Common Variable Immunodeficiency
Intervention(s): Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified, Dextrose, 5% in Water
Enrollment (expected or actual): 100
Sponsor: Grifols Therapeutics LLC
Completion Date (primary or actual): August 2002
Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
OBJECTIVES: I. Provide curative immunoreconstituting allogeneic bone marrow transplantation for patients with primary immunodeficiencies.
II. Determine relevant outcomes of this treatment in these patients including quality of survival, extent of morbidity and mortality from complications of the treatment (e.g., graft versus host disease, regimen related toxicities, B- cell lymphoproliferative disease), and completeness of functional immunoreconstitution.
First Posted: July 6, 2000
Condition(s): Immunologic Deficiency Syndromes, Chediak-Higashi Syndrome, Common Variable Immunodeficiency, Graft Versus Host Disease, X-Linked Lymphoproliferative Syndrome, Familial Erythrophagocytic Lymphohistiocytosis, Hemophagocytic Lymphohistiocytosis, X-linked Agammaglobulinemia, Wiskott-Aldrich Syndrome, Chronic Granulomatous Disease, X-linked Hyper IgM Syndrome, Severe Combined Immunodeficiency, Leukocyte Adhesion Deficiency Syndrome, Virus-Associated Hemophagocytic Syndrome
Intervention(s): anti-thymocyte globulin, busulfan, cyclophosphamide, cyclosporine, etoposide, methotrexate, methylprednisolone, prednisone, Allogeneic Bone Marrow Transplantation
Enrollment (expected or actual):
Sponsor: Fairview University Medical Center
Completion Date (primary or actual): December 2002
Study to Assess the Safety, Tolerability, and Effects of CHI-202 to Support Recovery From Physical Activity
The study is designed as a proof of concept, single-center, randomized, double-blind, placebo controlled study to assess the safety and efficacy of CHI-202 (cannabinoids and other ingredients) compared to placebo in the treatment of Delayed Onset Muscle Soreness (DOMS).
First Posted: August 30, 2021
Condition(s): Delayed Onset Muscle Soreness (DOMS)
Intervention(s): CHI-202, CHI-101
Enrollment (expected or actual): 40
Sponsor: Canopy Growth Corporation
Completion Date (primary or actual): February 4, 2022
Beryllium Infliximab Study: Clinical Interventional Trial
The goal of this research study is to test the clinical effectiveness of a drug called infliximab (Remicade) in chronic beryllium disease (CBD). This drug may reduce tumor necrosis factor-alpha (TNF-a), which is associated with more severe disease and inflammation in the lung. Receiving infliximab may help with symptoms, and may improve clinical testing data normally ordered by your doctor, such as breathing tests. Baseline and follow-up testing will look for improvements in breathing tests (pulmonary function testing), exchange of oxygen in the lungs (exercise test), chest x ray, and lung inflammation.
First Posted: May 27, 2005
Condition(s): Berylliosis, Beryllium Disease
Intervention(s): Infliximab, Placebo
Enrollment (expected or actual): 13
Sponsor: Maier, Lisa, M.D.
Completion Date (primary or actual): January 2009
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RCT of the Double Wire Technique for Sphincterotomy
Endoscopic cholangiography is a procedure which is performed to image the bile duct and perform therapy like removal of bile duct stones. It is currently standard of care to remove stones from the bile duct when found as they frequently cause complications like infections which can sometime be life threatening.
Therapy on the biliary tree, like for example stone removal, frequently requires inserting tools through the opening of the duct and cutting of the muscle which control the secretion of juices from the liver. Cutting the muscle helps with securing an easy access to the bile duct. It also helps facilitating dragging the stones out. On certain occasions placing a wire in the bile duct fails and instead the wire keeps entering the pancreatic duct whose opening is adjacent to the bile duct opening. There is evidence to suggest that keeping a wire in the pancreatic duct facilitates placing a second wire in the bile duct possibly because it straightens the duct. On certain occasions this also fails and we resort to cutting the muscle of the pancreas and the bile duct simultaneously to facilitate the access to the bile duct. The more attempt to enter the bile duct the higher the risk of inflammation in the pancreas known as pancreatitis. This makes decreasing the number of attempts at placing the wire in the duct desirable. One way to facilitate placement of the wire in the bile duct is to cut starting from the opening of the pancreas duct aiming toward the bile duct muscle. This often cuts the bile duct sphincter and exposes the bile duct opening. The study is trying to answer if cutting the bile duct sphincter muscle in the direction of the bile duct immediately after a wire has entered the pancreatic duct will make it easier to place the wire in the bile duct as compared to trying to place the wire in the bile duct without cutting the opening. While cutting the muscle canincrease the risk of pancreatitis, repeated attempts at accessing the bile duct can also increase the risk of pancreatitis. So if cutting the pancreatic muscle will facilitate entry to the bile duct and decrease the number of attempts at entering the bile duct then it might be a better way to approach the patient whom we had difficulty in entering the bile duct.
First Posted: February 15, 2013
Condition(s): Cholangiopancreatography, Endoscopic Retrograde, Sphincterotomy, Endoscopic, VATER'S AMPULLA
Intervention(s): Transpancreatic sphincterotomy
Enrollment (expected or actual): 16
Sponsor: Mayo Clinic
Principal Investigator: Douglas O. Faigel, Gastroenterologist
Completion Date (primary or actual): November 2016
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