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Sleep Well Observation Study
Insomnia is characterized by the recurring difficulty to fall or remain asleep despite motivation and means to do so. People with insomnia also experience excessive daytime sleepiness and other cognitive impairments while they are awake. Facing the situation mentioned and realizing that especially early preventive measures are needed to fight the increasing costs for treatment of sleep related diseases, effective nutrients might be a good and safe option to improve sleep quality.This single-arm, open-label, prospective, observational exploratory pilot study aims at collecting first data on efficacy and safety of "Sleep Well".
First Posted: February 28, 2023
Condition(s): Sleep Disturbance
Intervention(s): Sleep Well Sachet
Status: Not yet recruiting
Enrollment (expected or actual): 50
Allocation: N/A
Sponsor: A. Vogel AG
Principal Investigator:
Completion Date (primary or actual): June 3, 2023
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
Status: Recruiting
Enrollment (expected or actual): 30
Allocation:
Sponsor: Central Hospital, Nancy, France
Principal Investigator:
Completion Date (primary or actual): June 2023
Suppression of Upper Lip Hair Growth Using Novel Hemp Extract
A clinical case series will be conducted measuring upper lip hair suppression for cosmetic effects in a group of 25 adult women with hirsutism of the upper lip. The study will use a topical phytonutraceutical that contains two ingredients that have been shown to suppress hair growth. The serum contains Narcissus Tazetta Bulb Extract (0.2%) and a hemp-extract (0.15%) known to stimulate cannabinoid one (CB1) receptors.
The subjects will use the serum nightly for 60 days. High-power ProScope photographs will be obtained at the philtrum (above the center of the upper lip) as a landmark. Prior to starting the serum subjects will grow their upper lip hair for seven days. Hair shafts will be counted and graded for thickness and color using a standard methodology. The subjects will then use the serum for 60 days and will not be allowed to use laser, waxing, bleaching or tweezing during the duration of the study. Only shaving will be allowed. At the end of the 60 day course the subjects will grow their lip hair for seven days and the high-power photographs will be repeated at the same location based on landmarks.
An independent board-certified dermatologist will evaluate and grade the pre- and post- serum photographs for cosmetic effects, number and thickness of the hairs.
First Posted: August 21, 2023
Condition(s): Hirsutism, Hair Diseases
Intervention(s): Narcissus Tazetta Bulb Extract and Novel Hemp Extract
Status: Not yet recruiting
Enrollment (expected or actual): 25
Allocation:
Sponsor: Medical Life Care Planners, LLC
Principal Investigator: Gregory L Smith, MD, MPH, Principal Investigaor
Completion Date (primary or actual): December 1, 2023
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD).
This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.
First Posted: December 19, 2018
Condition(s): Parkinson's Disease (PD)
Intervention(s): ABBV-951
Status: Completed
Enrollment (expected or actual): 244
Allocation: Non-Randomized
Sponsor: AbbVie
Principal Investigator:
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
Intervention(s): Parcopa
Status: Completed
Enrollment (expected or actual):
Allocation: Randomized
Sponsor: UCB Pharma
Principal Investigator:
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
Intervention(s):
Status: Active, not recruiting
Enrollment (expected or actual): 410
Allocation:
Sponsor: Bio Shai Ltd.
Principal Investigator:
Completion Date (primary or actual): December 2019
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
Condition(s): Stroke
Intervention(s): Transcranial Magnetic Stimulation (TMS), Carbidopa-Levodopa, Methylphenidate, Amphetamine Sulfate, Placebo, Sham Transcranial Magnetic Stimulation (TMS), Transcranial Magnetic Stimulation (TMS) Training
Status: Completed
Enrollment (expected or actual): 33
Allocation: Randomized
Sponsor: Emory University
Principal Investigator: Cathrin Buetefisch, Dr. Cathrin Buetefisch
Completion Date (primary or actual): September 2016
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
Condition(s): Obesity
Intervention(s): Obese men, Normal-weight men
Status: Completed
Enrollment (expected or actual): 25
Allocation: Non-Randomized
Sponsor: University Hospital, Bordeaux
Principal Investigator:
Completion Date (primary or actual): November 2, 2017
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
Intervention(s): Alefacept
Status: Terminated
Enrollment (expected or actual): 3
Allocation: N/A
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
Status: Recruiting
Enrollment (expected or actual): 250
Allocation:
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
Condition(s): Obesity
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
Allocation: Non-Randomized
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
Allocation: Randomized
Sponsor: Unidad de Investigacion Medica en Enfermedades Renales
Principal Investigator:
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
Status: Completed
Enrollment (expected or actual): 25
Allocation: Non-Randomized
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
Status: Completed
Enrollment (expected or actual): 100
Allocation: Randomized
Sponsor: Grifols Therapeutics LLC
Principal Investigator:
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
Status: Terminated
Enrollment (expected or actual):
Allocation:
Sponsor: Fairview University Medical Center
Principal Investigator:
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
Status: Completed
Enrollment (expected or actual): 40
Allocation: Randomized
Sponsor: Canopy Growth Corporation
Principal Investigator:
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
Status: Terminated
Enrollment (expected or actual): 13
Allocation: Randomized
Sponsor: Maier, Lisa, M.D.
Principal Investigator:
Completion Date (primary or actual): January 2009
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
Status: Terminated
Enrollment (expected or actual): 16
Allocation: Randomized
Sponsor: Mayo Clinic
Principal Investigator: Douglas O. Faigel, Gastroenterologist
Completion Date (primary or actual): November 2016
Safety and Efficacy of CDB-2914 for Emergency Contraception
The purpose of this study is to assess the safety and efficacy of CDB-2914 for preventing pregnancy when taken 3 to 5 days after unprotected sexual intercourse.
First Posted: December 14, 2006
Condition(s): Emergency Contraception
Intervention(s): CDB-2914
Status: Completed
Enrollment (expected or actual): 1623
Allocation: N/A
Sponsor: HRA Pharma
Principal Investigator:
Completion Date (primary or actual): April 8, 2008
Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's Disease
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to continue testing whether ABBV-951 is safe, effective, and tolerable in participants with Parkinson's disease after completion of the parent study M15-741.
ABBV-951 is an investigational (unapproved) drug containing levodopa phosphate/carbidopa phosphate (LDP/CDP) given as infusion under the skin for the treatment of Parkinson's Disease. Participants who have successfully completed M15-741 study will immediately enter this study's treatment period to continue receiving ABBV-951. Adult participants with advanced PD will be enrolled. Approximately 130 adult participants will be enrolled in the study at approximately 65 sites worldwide.
Participants will receive continuous subcutaneous infusion (CSCI) of ABBV-951 for 24 hours daily during the Primary Treatment Period and during the optional Extended Treatment Period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular clinic visits and have remote assessments completed via phone calls during the course of the study. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.
First Posted: May 7, 2020
Condition(s): Parkinson's Disease (PD)
Intervention(s): ABBV-951
Status: Active, not recruiting
Enrollment (expected or actual): 130
Allocation: N/A
Sponsor: AbbVie
Principal Investigator:
Completion Date (primary or actual): June 19, 2025
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies
This is a standard of care treatment guideline for allogeneic hematopoetic stem cell transplant (HSCT) in patients with primary immune deficiencies.
First Posted: July 27, 2012
Condition(s): SCID, Omenn's Syndrome, Reticular Dysgenesis, Wiskott-Aldrich Syndrome, Bare Lymphocyte Syndrome, Common Variable Immunodeficiency, Chronic Granulomatous Disease, CD40 Ligand Deficiency, Hyper IgM Syndrome, X-linked Lymphoproliferative Disease, Hemophagocytic Lymphohistiocytosis, Griscelli Syndrome, Chediak-Higashi Syndrome, Langerhan's Cell Histiocytosis
Intervention(s): Alemtuzumab 0.3 mg, Cyclophosphamide, Busulfan, Stem Cell Transplantation, Fludarabine phosphate 40 mg, Melphalan, Alemtuzumab 0.2 mg, Busulfan, Fludarabine phosphate 30 mg, MESNA
Status: Recruiting
Enrollment (expected or actual): 30
Allocation: Non-Randomized
Sponsor: Masonic Cancer Center, University of Minnesota
Principal Investigator:
Completion Date (primary or actual): December 2024
First-In-Human Study of GFB-024 in Healthy Overweight and Obese Participants, and Participants With Type 2 Diabetes
GFB-024 is intended for use in patients with kidney disease such as diabetic nephropathy. This study is the first time GFB-024 has been used in humans. The first part of the study will assess the safety of a single dose of GFB-024 in healthy overweight and obese volunteers and the effect of GFB-024 on the body as compared to an inactive placebo medication. The second part of the study will assess the safety of repeated doses of GFB-024 in participants with Type 2 diabetes and the effect of GFB-024 on the body as compared to an inactive placebo medication.
First Posted: May 10, 2021
Condition(s): Kidney Diseases, Diabetic Nephropathies, Diabetes Complications, Diabetes Mellitus, Endocrine System Diseases
Intervention(s): GFB-024, Placebo
Status: Completed
Enrollment (expected or actual): 39
Allocation: Randomized
Sponsor: Goldfinch Bio, Inc.
Principal Investigator:
Completion Date (primary or actual): February 8, 2022
Enhancing Medication-based Analgesia in Humans- STUDY 2
This research is being done to evaluate whether combining medications that are FDA approved but have not yet been approved for combination treatment, can be an effective way to reduce pain. This is study 2 is a series of studies.
First Posted: July 30, 2019
Condition(s): Pain
Intervention(s): Within-subject test of blinded study medications
Status: Completed
Enrollment (expected or actual): 33
Allocation: N/A
Sponsor: Johns Hopkins University
Principal Investigator:
Completion Date (primary or actual): November 1, 2022
Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation
To identify factors and triggers influencing physical activity (PA) participation after structured cardiac rehabilitation (CR) among older adults who have enrolled in a center-based CR program, and compare the effects of a targeted health coaching intervention versus standard care immediately following structured CR on PA maintenance and functional fitness.
First Posted: March 17, 2023
Condition(s): Cardiac Rehabilitation, Health Coaching, Physical Activity
Intervention(s): Targeted Health Coaching Group, Standard Care Group
Status: Recruiting
Enrollment (expected or actual): 30
Allocation: Randomized
Sponsor: Duke University
Principal Investigator:
Completion Date (primary or actual): July 1, 2024
Effects of Sleep Disruption on Drug Response
The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects.
The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing.
The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(*) and healthy controls (N = 60).
(*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by NIDA to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis.
First Posted: September 21, 2018
Condition(s): Low Back Pain, Recurrent, Healthy
Intervention(s): Within-Subject test of blinded study medication
Status: Recruiting
Enrollment (expected or actual): 250
Allocation: Non-Randomized
Sponsor: Johns Hopkins University
Principal Investigator:
Completion Date (primary or actual): February 29, 2024
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