Search Results (1870)
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Immune Disorder HSCT Protocol
This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.
First Posted: April 1, 2013
Condition(s): Immune Deficiency Disorders, Severe Combined Immunodeficiency, Chronic Granulomatous Disease, X-linked Agammaglobulinemia, Wiskott-Aldrich Syndrome, Hyper-IgM, DiGeorge Syndrome, Chediak-Higashi Syndrome, Common Variable Immune Deficiency, Immune Dysregulatory Disorders, Hemophagocytic Lymphohistiocytosis, IPEX, Autoimmune Lymphoproliferative Syndrome, X-linked Lymphoproliferative Syndrome
Intervention(s): Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan
Enrollment (expected or actual): 20
Sponsor: Washington University School of Medicine
Completion Date (primary or actual): March 2024
Sequential Cadaveric Lung and Bone Marrow Transplant for Immune Deficiency Diseases
The purpose of this study is to determine whether bilateral orthotopic lung transplantation (BOLT) followed by cadaveric partially-matched hematopoietic stem cell transplantation (HSCT) is safe and effective for patients aged 5-45 years with primary immunodeficiency (PID) and end-stage lung disease.
First Posted: May 13, 2013
Condition(s): Severe Combined Immunodeficiency (SCID), Immunodeficiency With Predominant T-cell Defect, Unspecified, Severe Chronic Neutropenia, Chronic Granulomatous Disease (CGD), Hyper IgE Syndromes, Hyper IgM Deficiencies, Wiskott-Aldrich Syndrome, Mendelian Susceptibility to Mycobacterial Disease, Common Variable Immune Deficiency (CVID)
Intervention(s): CD3/CD19 negative allogeneic hematopoietic stem cells
Status: Enrolling by invitation
Enrollment (expected or actual): 16
Sponsor: Paul Szabolcs
Principal Investigator: Paul Szabolcs, Chief, Division of Blood and Marrow Transplant, Children's Hospital of Pittsburgh of UPMC
Completion Date (primary or actual): November 2023
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
This phase II trial studies how well giving fludarabine phosphate, melphalan, and low-dose total-body irradiation (TBI) followed by donor peripheral blood stem cell transplant (PBSCT) works in treating patients with hematologic malignancies. Giving chemotherapy drugs such as fludarabine phosphate and melphalan, and low-dose TBI before a donor PBSCT helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from the donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cell from a donor can make an immune response against the body's normal cells. Giving tacrolimus, mycophenolate mofetil (MMF), and methotrexate after transplant may stop this from happening
First Posted: February 9, 2012
Condition(s): Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Adult Grade III Lymphomatoid Granulomatosis, Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma, Aplastic Anemia, Burkitt Lymphoma, Childhood Acute Lymphoblastic Leukemia in Remission, Childhood Acute Myeloid Leukemia in Remission, Childhood Chronic Myelogenous Leukemia, Childhood Diffuse Large Cell Lymphoma, Childhood Grade III Lymphomatoid Granulomatosis, Childhood Immunoblastic Large Cell Lymphoma, Childhood Myelodysplastic Syndromes, Childhood Nasal Type Extranodal NK/T-cell Lymphoma, Chronic Myelomonocytic Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Congenital Amegakaryocytic Thrombocytopenia, Diamond-Blackfan Anemia, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Hepatosplenic T-cell Lymphoma, Juvenile Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Nodal Marginal Zone B-cell Lymphoma, Paroxysmal Nocturnal Hemoglobinuria, Peripheral T-cell Lymphoma, Polycythemia Vera, Post-transplant Lymphoproliferative Disorder, Previously Treated Myelodysplastic Syndromes, Primary Myelofibrosis, Recurrent Adult Acute Lymphoblastic Leukemia, Recurrent Adult Acute Myeloid Leukemia, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Grade III Lymphomatoid Granulomatosis, Recurrent Adult Hodgkin Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Adult T-cell Leukemia/Lymphoma, Recurrent Childhood Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Myeloid Leukemia, Recurrent Childhood Anaplastic Large Cell Lymphoma, Recurrent Childhood Grade III Lymphomatoid Granulomatosis, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Mantle Cell Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Mycosis Fungoides/Sezary Syndrome, Recurrent Small Lymphocytic Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia, Refractory Hairy Cell Leukemia, Refractory Multiple Myeloma, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Secondary Myelofibrosis, Severe Combined Immunodeficiency, Severe Congenital Neutropenia, Shwachman-Diamond Syndrome, Splenic Marginal Zone Lymphoma, T-cell Large Granular Lymphocyte Leukemia, Waldenstrom Macroglobulinemia, Wiskott-Aldrich Syndrome
Intervention(s): fludarabine phosphate, melphalan, total-body irradiation, tacrolimus, mycophenolate mofetil, methotrexate, laboratory biomarker analysis, allogeneic hematopoietic stem cell transplantation, peripheral blood stem cell transplantation
Enrollment (expected or actual): 94
Sponsor: Roswell Park Cancer Institute
Completion Date (primary or actual): May 28, 2015
Effect of L-Dihydoxyphenylserine on Locomotion, Postural Stability, and Fall Risk Reduction in Parkinson Disease
This research study is being done to determine whether treatment with L- Dihydroxyphenylserine (L-DOPS) versus placebo (an inactive substance that looks like study drug) in addition to other Parkinson Disease (PD) drugs will improve balance, walking, and reduce risk of falls and/or severity of falls in PD subjects. The study is also being done to determine the effectiveness, safety, and tolerability of L-DOPS, and whether it will decrease Freezing of Gait (FOG), improve apathy (generalized disinterest) or show a relationship between apathy and slowed movement and fall risk.
First Posted: June 24, 2016
Condition(s): Parkinson Disease
Intervention(s): L-DOPS, Placebo
Status: Active, not recruiting
Enrollment (expected or actual): 20
Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
Principal Investigator: Pam Dewey, Research Manager
Completion Date (primary or actual): June 2019
Evaluation of Diagnostic Performances of 18F-FDOPA PET KInetics
the investigators hypothesise that 18F-FDOPA PET kinetic parameters are good biomarkers to characterise suspected LGG brain lesions that exhibit no contrast on MRI, for identifying aggressive lesions. These parameters could constitute diagnostic biomarkers for this indication. This new diagnostic tool could enhance patient care in the short term in an evolving pathology affecting socially active subjects with a poor prognosis
First Posted: August 23, 2022
Intervention(s): PET/CT with 18F-DOPA
Status: Not yet recruiting
Enrollment (expected or actual): 88
Sponsor: Central Hospital, Nancy, France
Principal Investigator: Antoine VERGER, MD, PhD
Completion Date (primary or actual): January 30, 2025
Changes in Glutamatergic Neurotransmission of Severe TBI Patients
Studies in patients with disorders of consciousness (DOC) after severe brain injury implicate dysfunction of the anterior forebrain mesocircuit dysfunction a key underlying mechanism. The anterior forebrain metabolism in DOC is markedly downregulated across brain regions underpinning highly elaborated cognitive behaviors demonstrating a collapse of the level of synaptic background activity required for consistent goal-directed behavior and arousal regulation. Since dopamine levels are one of the primary controllers of the level of synaptic background activity within these forebrain structures and in regulating excitatory glutamatergic homeostasis, the investigators propose to investigate the specific contribution of presynaptic dopamine function in glutamatergic neurotransmission in posttraumatic DOC. The aim of the present study is to measure metabotropic glutamate receptors 5 occupancy in the main gutamatergic structures of the brain using (3-[18F]fluoro-5-(2-pyridinylethynyl)benzonitrile)-positron emission tomography ( [18F]FPEB-PET) at rest and following a short pharmacological challenge with amantadine, an N-methyl-D-aspartate receptor (NMDA-R) antagonist, following L-DOPA, and amantadine + L-DOPA. Using this novel technique in DOC the investigators will characterize the relevance of a presynaptic deficiency to synthesize and/or release dopamine in the final regulation of excitatory interneurons of the anterior forebrain mesocircuit.
It is unknown whether glutamatergic neurotransmission is affected across the population of subjects with DOC and, if this condition is secondary to a presynaptic dopaminergic failure of the anterior forebrain mesocircuit (i.e., down-regulation). Since the investigators previously identified the existence of a presynaptic dopaminergic deficit in these subjects due to a failure in the biosynthesis of dopamine, the investigators will evaluate if by providing the main biological substrate of the biosynthesis process (i.e., L-DOPA) the glutamatergic system regains homeostasis. The investigators therefore propose to investigate patients with posttraumatic DOC using [18F]FPEB-PET at rest and following short pharmacological challenges aimed at increasing glutamate and dopamine release.
First Posted: January 28, 2020
Condition(s): Disorder of Consciousness, Traumatic Brain Injury
Intervention(s): Amantadine + L-DOPA, NMDA blocker
Enrollment (expected or actual): 30
Sponsor: Weill Medical College of Cornell University
Completion Date (primary or actual): May 30, 2023
Short-term Effects of TOLCAPONE on Transthyretin Stability in Subjects With Leptomeningeal TTR Amyloidosis (ATTR)
The purpose of this study is to determine whether Tolcapone crosses from the blood stream into the fluid around the brain and stabilizes the protein that makes leptomeningeal amyloid. Tolcapone is a commercially available generic drug that treats Parkinson's disease.
The Investigator plans to evaluate Tolcapone as a treatment for ATTR (Transthyretin Amyloidosis), a rare genetic disease often causing death within 5-15 years after diagnosis. ATTR is characterized by deposition of misfolded protein known as amyloid, in one or more organ systems (including the peripheral and autonomic nervous systems, the heart, the brain and the eyes). The age at which symptoms begin to develop varies widely ranging between 20 to 70 years old. ATTR is progressive, and some variants can have a fatal outcome within a few years of presentation. Treatment options include supportive and symptomatic care that may slow or stop progressive decline in functional state but do not alter the pathological process. Liver transplant can be performed in selected patients but is limited by organ supply, requires lifelong immunosuppression, and may be complicated by progressive heart and nerve amyloid deposition. Importantly, liver transplant does not alter the natural course of central nervous system amyloid disease. To date, no treatment for ATTR penetrates the CNS.
At present there is no FDA approved treatment for ATTR amyloidosis in the US. In Europe, Tafamidis has been approved for treatment of stage 1 ATTR-polyneuropathy since 2012. Tafamidis and Tolcapone bind to the thyroxine binding site of TTR (with different drug-transthyretin interactions) and in so doing stabilizes the tetrameric form of TTR, preventing dissociation and amyloid fibril formation The preclinical and clinical data from a variety of experimental systems support the therapeutic activity of TOLCAPONE in TTR mediated disease.
First Posted: July 19, 2018
Condition(s): Transthyretin Amyloidosis, Amyloidosis, Leptomeningeal, Transthyretin-Related
Enrollment (expected or actual): 10
Sponsor: Boston University
Principal Investigator: John L. Berk, Associate Professor,Dept of Medicine, Amyloidosis Center
Completion Date (primary or actual): April 26, 2019
Endoscopic Access Loop With Bilio-enteric Anastomosis: A Prospective Randomized Comparison Between Gastric and Subcutaneous Accesses
Roux-en-Y hepaticojejunostomy is the standard procedure used by most hepatobiliary surgeons for biliary reconstruction following iatrogenic bile duct injury, benign and malignant CBD strictures, choledochal cysts and biliary tract tumors management. The incidence of anastomotic stricture following hepaticojejunostomy in experienced centers ranges between 5%-22%. Hepaticojejunostomy stricture is a serious complication of biliary surgery, if untreated, can lead to repeated cholangitis, intrahepatic stones formation, biliary cirrhosis, hepatic failure and eventually death.
Revision of hepaticojejunostomy is a complex procedure, the surgical procedure being made difficult by the sequelae of long-standing unrelieved biliary obstruction like portal hypertension due to secondary biliary cirrhosis, atrophy of liver lobes and presence of cholangiolytic liver abscess.
Endoscopic management is not only the least invasive but also very effective via either balloon dilatation or stenting of the stricture. In patients with "Roux-en-Y" hepaticojejunostomy, the endoscopic access to the anastomosis is hampered by the distance traveled by the jejunal loop until reaching the angle of the enteral anastomosis.
Many modifications of hepaticojejunostomy to provide permanent endoscopic access have been described in the literature including duodenal, gastric and subcutaneous access loops.
Gastric access loop was first described by Sitaram et al. Ten patients had undergone gastric access loop. Access loop was entered easily with the gastroscope in five patients in whom it was attempted. In a series with 16 cases, Hamad MA and El-Amin H assessed different construction of gastric access loop in the form of bilioenterogastrostomy the overall success rate of endoscopic access to the HJ through the three types of BEG was 87.5%, while it was 100% for BEG type III, which is a construction similar to the previous series (BEG) type.
Subcutaneous loop access was described by Chen et al. and by Huston et al. In Hutson's series of 7 patients, recurrent strictures were treated with repeated balloon dilations. The stone extractions were all successful. In most series, the subcutaneous loop was used for management os HJ stricture and intrahepatic stones by radiologic intervention. Recently the subcutaneous loop can be used as an endoscopic biliary access.
First Posted: August 17, 2017
Condition(s): Jaundice, Obstructive
Intervention(s): hepaticojejunostomy, modified hepaticojejunostomy with subcutaneous access loop, modified hepaticojejunostomy with gastric access loop
Status: Not yet recruiting
Enrollment (expected or actual): 30
Sponsor: Assiut University
Principal Investigator: Mohamad Raafat, Assistant lecturer at General surgery department
Completion Date (primary or actual): December 1, 2019
Peripheral Immune System in Individuals With Schizophrenia
The investigators are seeking healthy volunteers and people with schizophrenia or schizoaffective disorder for a clinical study of the immune system in psychotic disorders. This is an observational study, to understand the ways in which the immune system may be contributing to the disease process.
First Posted: November 5, 2021
Condition(s): Schizophrenia, Schizo Affective Disorder, Schizophreniform Disorders
Intervention(s): SCID (Standardized Clinical Interview for DSM-V), PSS (Perceived Stress Score), Urine Toxicology Screen, Vitals, Blood Work, PQ-B, COVID Screening, Positive and Negative Syndrome Scale (PANSS)
Enrollment (expected or actual): 100
Sponsor: Stanford University
Principal Investigator: Agnieszka Kalinowski, Clinical Instructor
Completion Date (primary or actual): August 31, 2023
Improving Therapeutic Learning for PTSD
The proposed project seeks to demonstrate the engagement of post-exposure dopamine neurotransmission and downstream acute reorganization of dopaminergic resting-state neural networks as a means of increasing consolidation of extinction memories formed during analogue exposure therapy in adult women with PTSD. Participants will include 120 women aged 21-50 with a current diagnosis of PTSD related to physical or sexual assault, English speaking, and medically healthy. Participants will complete the stages of the study across 2-3 days, depending on participant need.
First Posted: September 22, 2020
Condition(s): PTSD, Post Traumatic Stress Disorder
Intervention(s): L-DOPA, Placebo
Enrollment (expected or actual): 120
Sponsor: University of Wisconsin, Madison
Completion Date (primary or actual): December 2023
A Prospective Study of Treating Duodenal Papillary Sphincter in Different Ways During ERCP
Endoscopic retrograde cholangiopancreatography (ERCP) is commonly performed to remove bile duct stones.Endoscopic sphincterotomy (EST), endoscopic papillary balloon dilation (EPBD), and endoscopic sphincterotomy plus balloon dilation (sEST+EPBD) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. This study aimed to compare these methods for treating common bile duct (CBD) stones.
First Posted: January 31, 2018
Intervention(s): Erbao electric knife, Three-cavity incision knife, Columnar expansion balloon
Status: Enrolling by invitation
Enrollment (expected or actual): 450
Sponsor: Zhujiang Hospital
Completion Date (primary or actual): September 1, 2021
Davunetide (AL-108) in Predicted Tauopathies - Pilot Study
The primary objective of the study is to obtain preliminary safety and tolerability data with davunetide (NAP, AL-108) in patients with a tauopathy (frontotemporal lobar degeneration [FTLD] with predicted tau pathology, corticobasal degeneration syndrome [CBS] or progressive supranuclear palsy [PSP]). The secondary objectives of this study are to obtain preliminary data on short term changes (at 12 weeks) in a variety of clinical, functional and biomarker measurements from baseline, including cerebrospinal fluid (CSF) tau levels, eye movements, and brain MRI measurements.
First Posted: January 26, 2010
Condition(s): Predicted Tauopathies, Including, Progressive Supranuclear Palsy, Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17, Corticobasal Degeneration Syndrome, Progressive Nonfluent Aphasia
Intervention(s): davunetide (AL-108, NAP), Placebo nasal spray
Enrollment (expected or actual): 12
Sponsor: University of California, San Francisco
Principal Investigator: Adam Boxer, Associate Professor
Completion Date (primary or actual): December 2012
Study of the Nutraceutical Properties and Health Benefits of Traditional Components of the Mediterranean Diet
The present protocol is designed to conduct nutrigenomic and nutrigenetic studies on foods conforming to the Mediterranean diet, in order to determine the effect functional foods have on blood parameters (cholesterol metabolism, glucose metabolism, hepatic function, inflammation, nutritional status) and body composition in the context of four different diets (standard, high fat, high protein, low carbohydrate). The study focuses on the effect of these nutraceutical foods in relation to different diets. Diets were chosen to reflect the standard reference diets used by the general population, so as the outcomes of the addition of each interventional food element may be interpreted in the context of a variety of dietary patterns.
First Posted: July 1, 2013
Intervention(s): Hazelnuts, Chocolate, Red wine, Olive Oil, Wild mixed greens, Chestnut, No Dietary Supplement
Enrollment (expected or actual): 50
Sponsor: University of Rome Tor Vergata
Principal Investigator: LAURA DI RENZO, Professor of Human Nutrition
Completion Date (primary or actual): January 2016
Pragmatic Clinical Trials in Scleroderma
Systemic Sclerosis (SSc) is an autoimmune connective tissue disease characterized by autoantibodies, fibrosis and microvascular injury and endothelial cell activation that results in vascular damage. Vascular injury induces both innate and acquired immune responses resulting in fibroblast activation and organ fibrosis. SSc may target multiple organs, including: skin, lungs, heart, vascularization, kidneys, the gastrointestinal tract and musculoskeletal structures. Mortality among scleroderma patients is significant, with a 3.5 standardized mortality ratio (SMR) in studies of prevalent cases. This mortality may be increased in the early years of the disease, reaching a SMR of 4 in a multinational inception cohort. In general, treatment strategies target involved organs as early as possible to avoid damage. Many treatment options are available for each manifestation, but evidence with respect to the order of treatment is scarce. Financial costs, the lack of proper outcome measures, difficulty to recruit patients as a rare disease, all prevent the development of new big clinical trials, oppositely to other common diseases such as stroke or cancer. The heterogeneous features of SSc may make trials challenging. The current guidelines available are the British guidelines (2017) , and the updated European League Against Rheumatism (EULAR) guidelines, published in 2017. Management guidelines have some gaps regarding second-line treatment, combinations and there are no proposed algorithms.
With the pragmatic trials, the investigators intend to fill the gap between the complicated randomized clinical trials and the observational studies. Using the treatments that have already been proved useful in SSc, in an open-label randomized way and based on some refined expert-made algorithms, will allow the investigators to establish the order in how to use them.
Patients will be offered to participate with the collection of their clinical data and, if they give their consent, they will be randomized according to the algorithms. There will be an optional part of the study consisting in the collection of blood samples and skin samples for future research.
First Posted: August 1, 2018
Condition(s): Scleroderma, Systemic, Sclerosis, Systemic
Intervention(s): Interstitial lung disease induction algorithm, Pulmonary arterial hypertension algorithm, Raynaud's phenomenon algorithm, Digital ulcer algorithm, Inflammatory arthritis algorithm, Gastroesophageal reflux algorithm, Bacterial overgrowth algorithm, Constipation algorithm, Skin involvement algorithm, Pain algorithm
Status: Not yet recruiting
Enrollment (expected or actual): 400
Sponsor: University of West London
Principal Investigator: Andreu Fernandez Codina, Principal investigator
Completion Date (primary or actual): October 2021
Effect of Meditation and Controls and Subjects With Parkinson's Disease on Brain Activity Measured by fMRI With FDOPA
The purpose of this research is to use 18 F Fluorodopa positron emission tomography (FDOPA PET) to measure dopamine function, and utilize magnetic resonance imaging (MRI) to measure inflammatory and oxidative stress markers in persons with Parkinson's disease.
The overall goal of this study will be to further the understanding of the effects of a novel meditation technique called orgasmic meditation (OM) on these neurophysiological parameters.
First Posted: November 2, 2021
Condition(s): Parkinson Disease, Idiopathic Parkinson Disease
Intervention(s): [F-18] Fluorodopa Positron Emission Tomography, OM Meditation
Status: Not yet recruiting
Enrollment (expected or actual): 80
Sponsor: Andrew Newberg
Principal Investigator: Andrew Newberg, Professor, Department of Integrative Medicine and Nutritional Sciences; Professor, Department of Radiology
Completion Date (primary or actual): June 1, 2025
Proof of Mechanism Study for the Treatment of Social Anhedonia in ASD
This project will use the experimental medicine approach of a Phase IIa Proof of Mechanism 16-week, randomized, double-blind, controlled trial of L-DOPA versus placebo administration in combination with a 16 week social skills training group in order to: 1) identify differences in social reward processes in adolescent and young adult ASD participants versus healthy controls as measured by fMRI activation in reward circuitry; 2) provide evidence of dopaminergic moderating effects on social reward components in ASD with greater pre- to post-treatment changes expected in the subjects randomized to L-DOPA versus placebo; 3) examine the hypothesis that baseline readouts of putative dopamine signaling (wanting activation responses) will predict the extent of fMRI reward-related activation changes pre- to post-treatment; and, 4) examine the proposed relationship between pre- to post- L-DOPA fMRI reward changes and changes in individual self-report ratings of social wanting and ratings of videotaped positive affect in a structured interaction with an examiner. The study will enroll 56 participants with DSM-5 ASD between the ages of 13-30 years of age and 18 healthy control participants without histories of psychopathology for baseline comparisons.
First Posted: August 9, 2017
Intervention(s): L-DOPA versus Placebo, Social Skills Training
Enrollment (expected or actual): 56
Sponsor: University of California, Los Angeles
Principal Investigator: James McCracken, Principal Investigator
Completion Date (primary or actual): July 31, 2023
The Diagnostic Cut-off Value of Core Biomarkers of Alzheimer's Disease
The participant in this study includes Alzheimer's disease (AD including familial AD and sporadic AD) patients, amnestic mild cognitive impairment (aMCI) patients, non-AD dementia patients and cognitively normal control.
The purpose of this study is to establish the best cut-off value of cerebrospinal fluid (CSF) and blood β-amyloid (Aβ) 42/40, total tau (t-tau) , phosphorylated tau ,inflammatory factors, etc. in diagnosis of Alzheimer's disease (AD).
First Posted: August 25, 2021
Condition(s): Alzheimer's Disease
Enrollment (expected or actual): 3200
Sponsor: Capital Medical University
Principal Investigator: Jianping Jia, Chief Director
Completion Date (primary or actual): September 1, 2023
PROgressive Supranuclear Palsy CorTico-Basal Syndrome Multiple System Atrophy Longitudinal Study UK
Progressive Supranuclear Palsy (PSP), Cortico-Basal Degeneration (CBD) and Multiple System Atrophy (MSA) are degenerative brain conditions for which there are currently no curative treatments. To aid the development of new treatment trials, there is a pressing need to develop better methods for diagnosing these conditions early, and to track disease progression. The PROSPECT-M-UK study will collect standardised clinical data over time. Patients will also have the option to have a brain MRI scan, eye movement exam and donate blood, skin and spinal fluid samples, with the aim to identify "biomarkers" that can improve the accuracy of early diagnosis and track the natural time course of disease. Control participants and those not meeting criteria for Parkinson's disease or other defined conditions but are considered by the investigator group to be allied syndromes or at risk states (atypical parkinsonian syndromes), will also be examined. Patients can also participate via the CBD European registry or in a one-off study assessment through the cross-sectional study, which involves completing questionnaires and a blood sample donation.
First Posted: May 20, 2016
Condition(s): Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration, Multiple System Atrophy (MSA)
Enrollment (expected or actual): 900
Sponsor: University College, London
Completion Date (primary or actual): July 2023
Meta-analysis of Oat Fiber and Cardiovascular Risk Reduction.
Oat fibre has been shown to lower cholesterol and may have cardioprotective effects. However, whether this translates to actual cardiovascular risk reduction is unclear, as there is a lack of controlled human trials. To address this uncertainty, the investigator proposes to use established cardiovascular disease risk scores, such as those recommended by the Canadian Cardiovascular Society and other clinical practice groups, to create composite risk scores in assessing future risk. The data on oat fibre will be collected through a systematic review of controlled trials, composite cardiovascular risk scores will be calculated for each eligible study, and meta-analyses will be conducted to assess the overall effect. The findings generated by this proposed knowledge synthesis will help improve the health of consumers through informing evidence-based guidelines and improving health outcomes by educating healthcare providers and patients, stimulating industry innovation, and guiding future research design.
First Posted: December 28, 2021
Condition(s): Cardiovascular Diseases, Coronary Heart Disease
Intervention(s): Oats or Oat Fibre
Status: Active, not recruiting
Enrollment (expected or actual): 1
Sponsor: University of Toronto
Principal Investigator: John Sievenpiper, Associate Professor
Completion Date (primary or actual): January 30, 2022
Dog-rose, Cranberry Leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica and Sumac in Diabetes Mellitus
This study investigates the safety and combined effect of Cranberry leaves, Cranberry Berries, Alfalfa, Fenugreek, Lemon Beebrush, Urtica, Dog-rose, and Sumac on improving the glycemic profile of patients with type 2 diabetes mellitus compared to the placebo group.
First Posted: January 26, 2023
Condition(s): Type 2 Diabetes
Intervention(s): Capsules containing the combination products, Placebo capsules
Status: Not yet recruiting
Enrollment (expected or actual): 60
Sponsor: Tabriz University of Medical Sciences
Principal Investigator: Dr. Saeid Safiri, Principal Investigator
Completion Date (primary or actual): February 28, 2024
Human Rhinovirus Infection and Airway Remodeling Mediators
In this study, the following subjects will be exposed to human rhinovirus (HRV):
those with classification of mild-moderate asthma
healthy control subjects.
The investigators will study the kinetics of HRV-induced inflammatory and remodeling responses in a well characterized group of asthmatic subjects and compare these outcomes to those in a healthy, non-asthmatic control group.
First Posted: May 7, 2013
Intervention(s): GMP-grade HRV-39, Bronchoalveolar Lavage, Methacholine Inhalation Challenge, Nasal Lavage, Nasal Scrapings, Bronchial Brushings, Lung Mucosal Biopsy, Allergen Skin Prick Testing, Venipuncture, Bronchoscopy, Spirometry
Enrollment (expected or actual): 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Completion Date (primary or actual): July 2015
Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)
Bilateral subthalamic nucleus deep brain stimulation (B-STN DBS) is one of the most effective surgical treatments for PD patients suffering from levodopa-induced motor complications. The relatively low incidence of permanent adverse effects and the potential for neuroprotection and alteration of the natural course of PD suggest a highly favorable benefit-to-risk ratio of this procedure. Since neuroprotection is best applied early in the disease course when there are more surviving neurons, we believe that further investigation of this procedure is warranted. The proposed pilot study will provide the necessary data to substantiate the safety and tolerability of the procedure as well as provide data for the design of a full-scale, multicenter trial to investigate the hypothesis that B-STN DBS is a safe and effective treatment to slow the progression of PD.
First Posted: January 25, 2006
Condition(s): Parkinson's Disease
Intervention(s): B-STN DBS, Optimal drug therapy
Enrollment (expected or actual): 37
Sponsor: Vanderbilt University Medical Center
Principal Investigator: David Charles, Associate Professor of Neurology
Completion Date (primary or actual): January 2012
Beans/Bran Enriching Nutritional Eating For Intestinal Health Trial
The purpose of this study is to explore the effects of cooked navy bean powder or rice bran consumption on the stool microbiome and metabolome of colorectal cancer survivors and healthy adults.
First Posted: August 27, 2013
Condition(s): Colorectal Cancer Control and Prevention
Intervention(s): Placebo-Control Meals and Snacks, Cooked Navy Bean Powder Meals and Snacks, Rice Bran Meals and Snacks
Enrollment (expected or actual): 29
Sponsor: Colorado State University
Principal Investigator: Elizabeth P Ryan, Assistant Professor of Toxicology and Nutrition
Completion Date (primary or actual): December 2014
The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism
The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.
First Posted: January 15, 2013
Intervention(s): Fatty fish, Lean Fish, Alpha-linolenic acid, Control
Enrollment (expected or actual): 79
Sponsor: University of Eastern Finland
Completion Date (primary or actual): June 2014
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An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian Medications
This is an extension study to evaluate the long-term safety and tolerability of ABT-SLV187 in subjects with advanced Parkinson's disease.
First Posted: March 10, 2014
Condition(s): Advanced Parkinson's Disease
Enrollment (expected or actual): 30
Completion Date (primary or actual): October 31, 2019
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