Systematically Testing the Evidence on Marijuana

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

CT.gov Identifier: NCT05748574

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

CT.gov Identifier: NCT04441697

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

CT.gov Identifier: NCT06003062

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

CT.gov Identifier: NCT03781167

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

CT.gov Identifier: NCT00139880

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

CT.gov Identifier: NCT02283073

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

CT.gov Identifier: NCT00715520

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

CT.gov Identifier: NCT03157778

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

CT.gov Identifier: NCT01319851

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

CT.gov Identifier: NCT04518059

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

CT.gov Identifier: NCT03106688

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

CT.gov Identifier: NCT03262363

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

CT.gov Identifier: NCT00730314

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

CT.gov Identifier: NCT00220766

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

CT.gov Identifier: NCT00006054

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

CT.gov Identifier: NCT05026164

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

CT.gov Identifier: NCT00111917

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

CT.gov Identifier: NCT01792466

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

CT.gov Identifier: NCT00411684

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

CT.gov Identifier: NCT04379050

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

CT.gov Identifier: NCT01652092

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

CT.gov Identifier: NCT04880291

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

CT.gov Identifier: NCT04036968

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

CT.gov Identifier: NCT05773287

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

CT.gov Identifier: NCT03680287