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NCT00072579
Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment
https://clinicaltrials.gov/study/NCT00072579
null
COMPLETED
RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia. PURPOSE: This phase II trial is studying sargramostim to see how well it ...
NO
Leukemia
BIOLOGICAL: sargramostim
Cytogenetic response (complete and partial)
Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0|Time to progression|Survival
null
Wake Forest University Health Sciences
National Cancer Institute (NCI)
ALL
ADULT, OLDER_ADULT
PHASE2
null
OTHER
INTERVENTIONAL
Allocation: |Intervention Model: |Masking: NONE|Primary Purpose: TREATMENT
CCCWFU-23102|CDR0000340983|BRLX-02153|NCI-7350
2003-05
2006-04
2007-12
2003-11-05
null
2017-01-19
CCOP - Western Regional, Arizona, Phoenix, Arizona, 85006-2726, United States|CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States|CCOP - Mount Sinai Medical Center, Miami Beach, Florida, 33140, United States|Regional Radiation Oncology Center at Rome, Rome, Georgia, 30165, United States|CCOP...
null
{ "Sargramostim": [ { "intervention_type": "BIOLOGICAL", "description": "sargramostim", "name": "Sargramostim", "synonyms": [ "", "rGM-CSF", "Recombinant human granulocyte-macrophage colony stimulating factor", "Granulocyte-Macrophage Colony-Stimulating Fact...
NCT00517179
Effect of Vardenafil on Blood Pressure in Patients With Erectile Dysfunction Who Received Concomitant Doxazosin GITS
https://clinicaltrials.gov/study/NCT00517179
null
COMPLETED
The purpose of this study is to investigate the interaction between doxazosin GITS and vardenafil on blood pressure (Both systolic and diastolic blood pressure) in patients with both ED and BPH.
NO
Prostatic Hyperplasia|Impotence
DRUG: Vardenafil 10mg
Mean maximal change of the standing systolic blood pressure (SBP) from half hour prior to till six hour after administration of the drug (baseline) with vardenafil administration versus placebo, From half hour prior to till six hour after administration of the drug (baseline)
Mean maximal post-baseline change of the standing and supine diastolic blood pressure (DBP), From half hour prior to till six hour after administration of the drug (baseline)|Mean maximal post-baseline change supine SBP, and (3) the pattern of changes of the SBP and DBP from half hour prior to till six hours after admi...
null
Hospital Authority, Hong Kong
null
MALE
ADULT, OLDER_ADULT
null
40
OTHER_GOV
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE|Primary Purpose: TREATMENT
CRE-2006.017-T|HARECCTR0500057
2006-04
null
2007-05
2007-08-16
null
2011-06-16
Prince of Wales Hospital, Hong Kong, China
null
{ "Vardenafil": [ { "intervention_type": "DRUG", "description": "Vardenafil 10mg", "name": "Vardenafil", "synonyms": [ "Levitra", "Vardenafilo", "Vardenafil", "Vard\u00e9nafil", "Vardenafilum" ], "medline_plus_id": "a603035", "gener...
NCT00812279
Investigate the Exposure to Selected Smoke Constituents in Smokers Switching to Distillation Based Smoking Article
https://clinicaltrials.gov/study/NCT00812279
null
COMPLETED
The overall purpose of this clinical study conducted in confinement under well-defined conditions is to obtain initial data on the levels of human body exposure to selected smoked constituents of the SMAR cigarette. The main objective of this study is to compare the biomarkers of exposure to cigarette smoke constituen...
NO
Smoking
OTHER: Distillation based smoking article (SMAR cigarette)|OTHER: conventional cigarette|OTHER: smoking cessation
To demonstrate a reduction in the three primary biomarkers of exposure: Carboxyhaemoglobin concentration in blood, Urinary excretion of S-phenylmercapturic acid and urinary excretion of NNAL and NNAL-glucuronides (total NNAL), 5 days
To explore changes from baseline COHb, S-PMA, and total NNAL in the three study arms in the course of the study, 5 days|To explore changes from baseline in the three study arms with regard to urinary excretion of biomarkers of exposure to several other smoke constituents., 5 days|To assess urinary excretion of nicotine...
null
Philip Morris Products S.A.
null
ALL
ADULT
null
112
INDUSTRY
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
YVD-CS01-EU
2008-11
2009-02
2009-02
2008-12-22
null
2019-11-07
MTZ Clinical Research Inc., Warsaw, 02-106, Poland
null
{ "Distillation based smoking article (SMAR cigarette)": [ { "intervention_type": "OTHER" } ], "conventional cigarette": [ { "intervention_type": "OTHER" } ], "smoking cessation": [ { "intervention_type": "OTHER" } ] }
NCT03878979
Preoperative Immune Checkpoint Inhibitor for Patients With Primary Untreated or Recurrent/Metastatic SCCHN
https://clinicaltrials.gov/study/NCT03878979
null
COMPLETED
Nivolumab (also known as BMS-936558) before surgery to people with newly diagnosed or recurrent squamous cell carcinoma of head and neck (SCCHN).
NO
Head and Neck Squamous Cell Carcinoma|Head and Neck Cancer|Head and Neck Cancer Metastatic
DRUG: Nivolumab 480mg and surgical resection
Safety as measured by number of participants with drug-related adverse events, Safety of neoadjuvant nivolumab administration in patients with newly diagnosed head and neck cancer and those with locoregional recurrence or oligometastatic disease undergoing surgical resection measured by number of participants with drug...
Major pathologic response rate, Number of participants with < 10% residual tumor in the resection specimen., Day 0 (after surgery)|Progression free survival (PFS), Number of months until radiologic or clinical progression or death, whichever occurs first., up to 3 years|Radiographic response rate, Number of participant...
null
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Bristol-Myers Squibb
ALL
ADULT, OLDER_ADULT
PHASE2
26
OTHER
INTERVENTIONAL
Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
J1923|IRB00207577|CA209-9H7
2019-07-08
2023-10-17
2023-10-17
2019-03-18
null
2024-02-20
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, 21287, United States
null
{ "Nivolumab": [ { "intervention_type": "DRUG", "description": "Nivolumab 480mg and surgical resection", "name": "Nivolumab", "synonyms": [ "ONO-4538", "MDX 1106", "MDX-1106", "ONO 4538", "ONO4538", "BMS936558", "Opdivo", "Niv...
NCT05602779
Leverage Noninvasive Transcutaneous Vagus Nerve Stimulation to Reduce Suicidal Behaviors in Vulnerable Adolescents
https://clinicaltrials.gov/study/NCT05602779
null
RECRUITING
Suicidal thoughts, suicide attempts, and suicide are increasingly common in adolescence. Current face-to-face prevention approaches are of limited effectiveness, rely on extensive resources, and are at odds with adolescents digital preferences. We will evaluate two unconventional but promising interventions delivered ...
NO
Self Harm|Suicidal Ideation
DEVICE: tVns Program|OTHER: Phone App Program|COMBINATION_PRODUCT: tVNS and Phone App Program|OTHER: Enhanced Treatment as Usual
Change from Baseline in Non-Suicidal Self Injury Behaviors at 30 Days, Teens will be assessed at the baseline lab visit for emotion regulation and self-harm through questions on the Qualtrics survey (measures are Difficulties in Emotion Regulation Scale and the Youth Self Report). They will also complete a face-to-face...
Adherence to tVNS and Phone App intervention from Baseline to 30 days., Using data from the Xen device and the phone app, we will be able to determine the number of occurances the device and app were accessed, as well as for how much time each was actively used. Participants will also report on acceptability, obtrusive...
null
University of Notre Dame
University of Rochester
ALL
CHILD
null
212
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION
22-08-7372
2023-10-08
2027-04-15
2027-09-30
2022-11-02
null
2023-12-06
University of Notre Dame, South Bend, Indiana, 46617, United States
null
{ "tVns Program": [ { "intervention_type": "DEVICE" } ], "Phone App Program": [ { "intervention_type": "OTHER" } ], "tVNS and Phone App Program": [ { "intervention_type": "COMBINATION_PRODUCT" } ], "Enhanced Treatment as Usual": [ { "intervention_type": ...
NCT01126879
Genistein in Treating Patients With Prostate Cancer
https://clinicaltrials.gov/study/NCT01126879
null
TERMINATED
RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.
YES
Adenocarcinoma of the Prostate|Recurrent Prostate Cancer|Stage I Prostate Cancer|Stage II Prostate Cancer|Stage III Prostate Cancer
DIETARY_SUPPLEMENT: genistein|OTHER: placebo|PROCEDURE: therapeutic conventional surgery
Number of Circulating Prostate Cells (CPCs) in the Blood as Determined by qRT-PCR for PSA on RNA Extracted From PBMNCs, Blood will be collected to analyze the number of CPCs at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery., At screening, after 1-month of treatment, at surgery a...
Natural History of Circulating Prostate Cells (CPCs) in a Cohort of Subjects Prior to and Post Radical Prostatectomy, Blood will be drawn to analyze the natural history of circulating prostate cells (CPCs) in a cohort of subjects at baseline and 1 and 12 months after surgery., At baseline, 1 and 12 months after surgery...
null
Northwestern University
National Cancer Institute (NCI)
MALE
ADULT, OLDER_ADULT
PHASE2
12
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
NCI 09U2|NCI-2010-00941|STU00019487|P50CA090386
2011-02-03
2013-05-09
2013-12-28
2010-05-20
2019-07-02
2019-09-10
Northwestern University, Chicago, Illinois, 60611, United States
null
{ "genistein": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "placebo": [ { "intervention_type": "OTHER" } ], "therapeutic conventional surgery": [ { "intervention_type": "PROCEDURE" } ] }
NCT05865379
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
https://clinicaltrials.gov/study/NCT05865379
BUSTON-01
NOT_YET_RECRUITING
The goal of this interventional investigation is to compare BUFY01 with SVS20 in the treatment of patients with dry eye disease. The main questions it aims to answer are: * Is BUFY01 non-inferior to SVS20 in terms of signs of DED? * Is BUFY01 non-inferior to SVS20 in terms of symptoms of DED? Participants will be ask...
NO
Dry Eye Disease
DEVICE: BUFY01 eye drops in single-dose containers|DEVICE: SVS20 eye drops in single-dose containers
Signs, Change from baseline in Oxford score (0-15, a higher score meaning a worse outcome), Day 28
Symptoms, Change from baseline in Ocular Surface Disease Index, Day 28
null
TRB Chemedica International SA
null
ALL
ADULT, OLDER_ADULT
null
80
INDUSTRY
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
BUFY01-CT-2101
2024-03
2025-10
2025-10
2023-05-18
null
2023-11-24
null
null
{ "BUFY01 eye drops in single-dose containers": [ { "intervention_type": "DEVICE" } ], "SVS20 eye drops in single-dose containers": [ { "intervention_type": "DEVICE" } ] }
NCT03791879
Caudal Dexmedetomidine Analgesia in Pediatrics .
https://clinicaltrials.gov/study/NCT03791879
null
COMPLETED
Dexmedetomidine (DEXM) is a highly selective α2-adrenoceptor agonist that has been used increasingly in pediatric anesthesia. This prospective double blinded randomized comparative study is designed to evaluate the analgesic effect of caudal increasing doses of DEXM 0.5 , 1 , 1.5 , 2µg/kg combined with Levobupivacaine ...
NO
164 Boys for Hypospadias Surgery Under General Anesthesia With Caudal Block
DRUG: Caudal dexamedatomidine analgesia
Time to (1st analgesic request objective pain score (OPS) ≥4), time from full recovery till child express moderate pain OPS 4 and ask for the first analgesic dose, Basal (0) till 24 hours.
null
null
Mansoura University
null
MALE
CHILD
null
164
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
MFM IR.18.11.322 - 2018/11/11
2019-01-01
2020-10-01
2020-10-15
2019-01-03
null
2021-03-01
Anesthesia department,Faculty of medicine, Mansoura univerisety, Mansoura, Egypt
null
{ "Caudal dexamedatomidine analgesia": [ { "intervention_type": "DRUG" } ] }
NCT03877679
The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients
https://clinicaltrials.gov/study/NCT03877679
null
UNKNOWN
Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus. * Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva. * Compare the outcome of new preparation with the gold standard treatment (corticosteroid...
NO
Oral Lichen Planus
DRUG: Triamcinolone|DRUG: Turmeric paste
Pain intensity, measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain, 4 weeks
clinical sign score, measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm, Baseline , 2nd week and 4th week|IL-33 level in saliva, by ELISA, base line and 4th week
null
Cairo University
null
ALL
CHILD, ADULT, OLDER_ADULT
PHASE1
40
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
OMED2:5:1
2019-05-01
2020-05-01
2020-06-01
2019-03-18
null
2019-03-18
null
null
{ "Triamcinolone": [ { "intervention_type": "DRUG", "description": "Triamcinolone", "name": "Triamcinolone", "synonyms": [ "Triamcinolona", "Triacort", "Aristogel", "9-fluoro-11\u03b2,16\u03b1,17,21-tetrahydroxypregna-1,4-diene-3,20-dione", "Fluoxypr...
NCT03960879
DNA Methylation for Screening Uterine Cervical Lesions
https://clinicaltrials.gov/study/NCT03960879
null
UNKNOWN
The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study. This study will include 300 unselected patients with definite histological results. All the cervical ...
NO
DNA Methylation|Uterine Cervical Cancer|High Grade Squamous Intraepithelial Lesions|Low Grade Squamous Intraepithelial Lesions
DIAGNOSTIC_TEST: DNA methylation|DIAGNOSTIC_TEST: High-risk HPV|DIAGNOSTIC_TEST: TCT
Sensitivity of DNA methylation, Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL), 1 year|Specificity of DNA methylation, Specificity of DNA methylation compared with histological results for the differenti...
Positive predictive value of DNA methylation, Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL, 1 year|Negative predictive value of DNA methylation, Negative predictive value of DNA methylation compared with histological results for the ...
null
Lei Li
null
FEMALE
ADULT, OLDER_ADULT
null
300
OTHER
OBSERVATIONAL
Observational Model: |Time Perspective: p
METHY2
2019-06-01
2020-06-01
2020-06-01
2019-05-23
null
2019-05-24
Lei Li, Beijing, Beijing, 100730, China
null
{ "DNA methylation": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Human Papillomavirus (HPV) Vaccine (Cervarix)": [ { "intervention_type": "DIAGNOSTIC_TEST", "description": "High-risk HPV", "name": "Human Papillomavirus (HPV) Vaccine (Cervarix)", "synonyms": [ ...
NCT02385279
Study Comparing the MiStent SES Versus the XIENCE EES Stent
https://clinicaltrials.gov/study/NCT02385279
DESSOLVE III
COMPLETED
The primary objective of this study is to compare the performance of MISTENT to that of XIENCE in an all-comers patient population with symptomatic ischemic heart disease. The patients will be followed through 3 years for major clinical events.
YES
Coronary Stenosis
DEVICE: MiStent|DEVICE: XIENCE EES
Number of Participants With Occurrence of a Device Oriented Composite Endpoint (DOCE), DOCE is a composite of clinical endpoint of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and clinically-indicated target lesion revascularization., 12 months postprocedure
POCE, POCE defined as all-cause death, any Myocardial Infarction (MI), or any revascularization, At 12 months|MACE, MACE defined as all-cause death, any MI, or any Target Vessel Revascularization (TVR), At 12 months|Target Vessel Failure (TVF), Target Vessel Failure (TVF) defined as cardiac death, TV MI, or clinically ...
null
ECRI bv
Micell Technologies|Stentys
ALL
ADULT, OLDER_ADULT
null
1,398
INDUSTRY
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
ECRI-005
2015-03-20
2017-01-31
2021-02-04
2015-03-11
2023-05-08
2023-05-08
Research Center Corbeil, Corbeil, France|Research Center Nimes, Nimes, France|Research Center Poitiers, Poitiers, France|Research Center Jena, Jena, Germany|Research Center Leipzig, Leipzig, Germany|Research Center Munster, Munster, Germany|Research Center Ulm, Ulm, Germany|Research Center Wiesbaden, Wiesbaden, Germany...
Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT02385279/Prot_SAP_000.pdf
{ "MiStent": [ { "intervention_type": "DEVICE" } ], "Erythromycin": [ { "intervention_type": "DEVICE", "description": "XIENCE EES", "name": "Erythromycin", "synonyms": [ "Erycette", "Tiloryth", "T-Stat", "PCE", "Phosphate, Erythromy...
NCT04128579
Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis
https://clinicaltrials.gov/study/NCT04128579
EQUALISE
COMPLETED
This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis
NO
Lupus Erythematosus|Lupus Nephritis
DRUG: Itolizumab [Bmab 600]
Incidence of Treatment Emergent Adverse Events, Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., Type A up to Day 57 or Type B up to Day 253
To characterize the PK of itolizumab, To characterize the pharmacokinetics of itolizumab, Type A up to Day 57 or Type B up to Day 253|CD6 receptor occupancy, the % levels of free versus EQ001-bound CD6 receptor on T cells, Type A up to Day 57 or Type B up to Day 253
null
Equillium
Biocon Limited
ALL
ADULT, OLDER_ADULT
PHASE1
55
INDUSTRY
INTERVENTIONAL
Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
EQ001-19-002
2019-10-01
2023-11-16
2024-01-18
2019-10-16
null
2024-02-28
AKDHC Medical Research Services, LLC, Sun City, Arizona, 85351, United States|California Institute of Renal Research, Chula Vista, California, 91910, United States|University of California San Diego Perlman Ambulatory Clinic, La Jolla, California, 92037, United States|Clinical Research of West Florida - Clearwater, Cle...
null
{ "Itolizumab": [ { "intervention_type": "DRUG", "description": "Itolizumab [Bmab 600]", "name": "Itolizumab", "synonyms": [ "Itolizumab" ], "drugbank_id": "DB16207", "generic_names": [ "Itolizumab" ] } ] }
NCT03793179
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
https://clinicaltrials.gov/study/NCT03793179
null
ACTIVE_NOT_RECRUITING
This phase III trial studies whether pembrolizumab alone as a first-line treatment, followed by pemetrexed and carboplatin with or without pembrolizumab after disease progression is superior to induction with pembrolizumab, pemetrexed and carboplatin followed by pembrolizumab and pemetrexed maintenance in treating pati...
NO
Lung Non-Squamous Non-Small Cell Carcinoma|Stage IIIB Lung Cancer AJCC v8|Stage IIIC Lung Cancer AJCC v8|Stage IV Lung Cancer AJCC v8
PROCEDURE: Biospecimen Collection|DRUG: Carboplatin|PROCEDURE: Computed Tomography|PROCEDURE: Magnetic Resonance Imaging|BIOLOGICAL: Pembrolizumab|DRUG: Pemetrexed|PROCEDURE: Positron Emission Tomography
Overall survival (OS), OS distributions will be estimated using the Kaplan-Meier method., From randomization to death from any cause, assessed up to 5 years post treatment
Progression-free survival (PFS), PFS distributions will be estimated using the Kaplan-Meier method., From randomization to documented disease progression or death from any cause, assessed up to 5 years post treatment|Best objective response, Best objective response will be evaluated via Response Evaluation Criteria in ...
null
National Cancer Institute (NCI)
null
ALL
ADULT, OLDER_ADULT
PHASE3
600
NIH
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
NCI-2018-03695|NCI-2018-03695|EA5163|EA5163|U10CA180820
2019-04-05
2028-12-31
2028-12-31
2019-01-04
null
2024-06-17
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, 36688, United States|Anchorage Associates in Radiation Medicine, Anchorage, Alaska, 98508, United States|Anchorage Radiation Therapy Center, Anchorage, Alaska, 99504, United States|Alaska Breast Care and Surgery LLC, Anchorage, Alaska, 99508, Unite...
null
{ "Biospecimen Collection": [ { "intervention_type": "PROCEDURE" } ], "Carboplatin": [ { "intervention_type": "DRUG", "description": "Carboplatin", "name": "Carboplatin", "synonyms": [ "Carboplatino", "Carboplatin", "cis-diammine(1,1-cyclobutanedic...
NCT02312479
Safety and Performance Study of the Nyxoah SAT System for Treating OSA
https://clinicaltrials.gov/study/NCT02312479
null
TERMINATED
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
NO
Obstructive Sleep Apnea
DEVICE: Nyxoah SAT system
Incidence of serious device related adverse events, 6-months post-implantation|Mean change of AHI (Apnea-Hypopnea Index) measured by in-lab polysomnography (PSG) from baseline measurement to 6-months post-implantation, 6-months post-implantation
null
null
Nyxoah S.A.
null
ALL
ADULT, OLDER_ADULT
null
6
INDUSTRY
INTERVENTIONAL
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
SAT2014A
2014-12
2015-11
2016-04
2014-12-09
null
2016-09-27
Antwerp University Hospital, Edegem, Belgium|Universitäts-HNO-Klinik Mannheim, Mannheim, Germany
null
{ "Nyxoah SAT system": [ { "intervention_type": "DEVICE" } ] }
NCT04236479
Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)
https://clinicaltrials.gov/study/NCT04236479
null
ACTIVE_NOT_RECRUITING
The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing ...
NO
Congenital Heart Disease (CHD)
BIOLOGICAL: BM-MSC
Number of subjects who experience serious adverse events, adverse events, and/or early treatment discontinuations., Dose Limiting Toxicity is attributable to the MSC administration., 45 days following the MSC administration
Actual magnitude of differences in neuroimaging and neurodevelopmental variables will be measured after MSC delivery., Secondary objective will be measured by using the Pediatric Cardiac Critical Care Consortium (PC4) registry system., 18 months
null
Catherine Bollard
null
ALL
CHILD
PHASE1
17
OTHER
INTERVENTIONAL
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Pro00011914
2020-07-29
2024-09
2025-04
2020-01-22
null
2023-09-21
Childrens National Health System, Washington, District of Columbia, 20010, United States
null
{ "BM-MSC": [ { "intervention_type": "BIOLOGICAL" } ] }
NCT03468179
Oatmeal Effect on N-acyl-phosphatidylethanolamines
https://clinicaltrials.gov/study/NCT03468179
NAPE
COMPLETED
N-acyl-phosphatidylethanolamine (NAPEs) and their active metabolites, N-acyl-ethanolamides (NAEs) are lipid satiety factors that are normally biosynthesized in the intestinal tract in response to food intake. Reduced levels of NAPEs and NAEs have been found in obese individuals, and increasing plasma NAPE and NAEs leve...
YES
Obesity|Cardiovascular Diseases
DIETARY_SUPPLEMENT: Oatmeal
Change in Serum N-acyl-phosphatidylethanolamine (NAPE), Change in serum NAPE from baseline to 120 minutes post-oatmeal challenge, Baseline to 120 minutes
Serum NAPE, Serum NAPE Levels at 30, 60, and 90 minutes, 30, 60, and 90 minutes|Serum N-acyl-ethanolamides (NAE), Serum NAE levels at baseline, 30, 60, 90 and 120 minutes, baseline 30, 60, 90 and 120 minutes
null
Vanderbilt University Medical Center
null
ALL
ADULT, OLDER_ADULT
null
10
OTHER
INTERVENTIONAL
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
JJWPending
2018-10-07
2018-12-31
2018-12-31
2018-03-16
2019-12-13
2019-12-13
Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/79/NCT03468179/ICF_000.pdf|Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/79/NCT03468179/Prot_SAP_001.pdf
{ "Oatmeal": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }
NCT02328079
Steroid-Antiviral Treatment in Rehabilitation of Facial Palsy
https://clinicaltrials.gov/study/NCT02328079
null
COMPLETED
The purpose of this study is to assess the efficacy of antiviral medicine (acyclovir) in recovery of complete facial Palsy. Fifty patients (Males and females) with acute Facial Palsy within the first 3 days of onset with age ranged from 15-60 years old. Each patient was submitted to the following clinical evaluation us...
NO
Facial Palsy
DRUG: Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)
Facial muscle function using clinical scale, Evaluations of facial muscle function using clinical scale were performed blindly by a neurologist who was unaware of the type of treatment of which the patient had received, 2 months
Nerve conduction study of facial nerve., Measurment of facial n. coduction, 2 months
null
Assiut University
null
ALL
CHILD, ADULT
null
50
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Antiviral in facial palsy
2013-04
2014-11
2014-11
2014-12-31
null
2020-09-16
null
null
{ "Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)": [ { "intervention_type": "DRUG" } ] }
NCT01801579
Reproducibility of Ankle Brachial Index After Maximal Exercise
https://clinicaltrials.gov/study/NCT01801579
RICATEM
COMPLETED
Hemodynamic changes in the lower limbs are very important and rapid after maximal exercise. The automatic method allows a fastest measurement of the Ankle-Brachial Index (ABI). Thus, it appears important to know whether automatic assessment of ABI is as reliable and reproducible as the manual method.
NO
Normal Subjects
null
Test-retest difference in ankle to brachial pressure index, Comparison of differendces observed on test-retest measures with manual and automatic measurements, up to 2 week
Duration of recordings., Comaprison of the time needed to complete the recording with automatic vs. manual techniques, up to 2 weeks
null
University Hospital, Angers
Institut de formation en éducation physique et en sport dAngers/Les Ponts de Cé
ALL
ADULT
null
15
OTHER_GOV
OBSERVATIONAL
Observational Model: |Time Perspective: p
2012-A01036-37
2012-11
2014-04
2014-04
2013-03-01
null
2016-02-12
University Hospital, Angers, 49933, France
null
{}
NCT02854579
Neural Progenitor Cell and Paracrine Factors to Treat Hypoxic Ischemic Encephalopathy
https://clinicaltrials.gov/study/NCT02854579
null
UNKNOWN
The purpose of this study is to investigate the efficacy and safety of allogenic neural progenitor cell and paracrine factors of human mesenchymal stem cells for patients with moderate/severe Hypoxic-Ischemic Encephalopathy
NO
Hypoxic-Ischemic Encephalopathy
BIOLOGICAL: neural progenitor cell|BIOLOGICAL: Paracrine factors|BIOLOGICAL: progenitor cell and paracrine factors
Neonatal Behavioral Neurological Assessment, 14days after birth|number of adverse events, adverse events like fever、infection、seizures、hemorrhage coursed by interventions, 7days after cell or factor injection|Neonatal Behavioral Neurological Assessment, 28days after birth
Bayley score, Gross motor function measure assessment for children diagnosed cerebral palsy, 12 months after birth|Bayley score, Gross motor function measure assessment for children diagnosed cerebral palsy, 18 months after birth|Peabody development measure scale, Gross motor function measure assessment for children di...
null
Navy General Hospital, Beijing
Bethune International Peace Hospital|Daping Hospital and the Research Institute of Surgery of the Third Military Medical University|Hunan Childrens Hospital|Shangluo Central Hospital|252 Military Hospital
ALL
CHILD
null
120
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
NavyGHB-P-01
2013-01
2017-07
2017-12
2016-08-03
null
2016-08-03
Navy General Hospital, Beijing, Beijing, 100048, China|Navy General Hospital, Beijing, 100048, China
null
{ "neural progenitor cell": [ { "intervention_type": "BIOLOGICAL" } ], "Paracrine factors": [ { "intervention_type": "BIOLOGICAL" } ], "progenitor cell and paracrine factors": [ { "intervention_type": "BIOLOGICAL" } ] }
NCT02898779
Metabolism and Pharmacokinetics of Primaquine Enantiomers in Human Volunteers, Study 1
https://clinicaltrials.gov/study/NCT02898779
null
COMPLETED
To investigate the comparative tolerability, metabolism and pharmacokinetics of individual enantiomers of PQ in healthy human volunteers. The specific aim is the comparative evaluation of the metabolism, pharmacokinetic behavior, and tolerability of the isomers of PQ (RPQ and SPQ and the racemic mixture RSPQ) in normal...
NO
Malaria
DRUG: Primaquine, R-Primaquine, S-Primaquine, SR Primaquine
Primary outcome: Plasma concentration of parent primaquine and carboyprimaquine following a single dose treatment with primaquine (racemate or enantiomers) not to exceed 45 mg, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers, b...
Area Under Curve (AUC) for primaquine up to 24 hours after the primaquine administration, This study would provide information on differential pharmacokinetics and metabolism of enantiomers of primaquine in normal human volunteers, between 0-24 hours|Maximum concentration (Cmax) for primaquine up to 24 hours after the ...
null
University of Mississippi, Oxford
null
ALL
ADULT
PHASE1
36
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
PQ Study 1
2017-05-01
2018-03-01
2018-03-01
2016-09-13
null
2018-05-15
University of Mississippi, Oxford, Mississippi, 38677, United States
null
{ "Primaquine": [ { "intervention_type": "DRUG", "description": "Primaquine, R-Primaquine, S-Primaquine, SR Primaquine", "name": "Primaquine", "synonyms": [ "Primacin", "Diphosphate, Primaquine", "Primaquine", "Primaquin", "Phosphate, Primaquine", ...
NCT02840279
A Multiple Ascending Dose Study of BPN14770 in Healthy Young and Elderly Male or Female Subjects
https://clinicaltrials.gov/study/NCT02840279
null
COMPLETED
This is a randomized, double-blind (Investigator and subject-blinded) placebo-controlled, multiple, ascending-dose study to evaluate the safety, tolerability, and pharmacokinetic profile of BPN14770 in healthy young and elderly male and female subjects and to provide a preliminary assessment of the cognitive effects of...
NO
Alzheimers Disease
DRUG: BPN14770|DRUG: Placebo
Number of Participants with Adverse Events as a Measure of Safety and Tolerability, Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead elec...
Area Under the Curve from Time Zero to Twelve Hours [AUC0-12], 2 weeks|Area Under the Concentration Time Curve from Zero to 12 Hours, Corrected for Dose [AUC12/D], 2 weeks
ISLT-D, International Shopping List Test words recalled at 24 hours, 2 weeks|GMLT-D, Groton Maze Learning Test errors at 24 hours, 2 weeks
Tetra Discovery Partners
null
ALL
ADULT, OLDER_ADULT
PHASE1
77
INDUSTRY
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
BPN14770-CNS-102
2016-06
2016-11
2016-12
2016-07-21
null
2017-01-18
Jasper Clinic, Kalamazoo, Michigan, 49007, United States
null
{ "BPN14770": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }
NCT00332579
Double-Blind Naltrexone in Kleptomania
https://clinicaltrials.gov/study/NCT00332579
null
COMPLETED
The goal of the proposed study is to evaluate the efficacy and safety of naltrexone in kleptomania.
YES
Kleptomania
DRUG: Naltrexone|DRUG: Placebo
Yale Brown Obsessive Compulsive Scale Modified for Kleptomania (K-YBOCS), The K-YBOCS measures symptom severity (urges/thoughts and behavior) across the past week. Scores range from 0 (no symptoms) to 40 (highest symptom severity)., K-YBOCS is done at each visit by the investigator.
null
null
University of Minnesota
null
ALL
ADULT, OLDER_ADULT
PHASE2
25
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
0602M82626
2006-05-01
2008-09-01
2008-09-01
2006-06-01
2012-05-04
2019-07-29
University of Minnesota, Minneapolis, Minnesota, 55454, United States
null
{ "Naltrexone": [ { "intervention_type": "DRUG", "description": "Naltrexone", "name": "Naltrexone", "synonyms": [ "Naltrexona", "Nalorex", "Antaxone", "Celupan", "N-Cyclopropylmethylnoroxymorphone", "Naltrexon", "Nemexin", "EN...
NCT03789279
Observational Study of Hand Function After Distal Transradial Access for Angiography
https://clinicaltrials.gov/study/NCT03789279
RATATOUILLE
COMPLETED
Traditionally, coronary angiograms are performed through the radial artery which is accessed above the palm of the right hand. In recent years, some cardiologists are performing this procedure from the back of the wrist in as the radial artery courses through the anatomical snuffbox (distal radial access). The aim of t...
NO
Radial Artery Occlusion|Nerve Injury
null
Prevalence of hand dysfunction, Any significant deterioration from baseline in hand function according to the 5 studied domains., 1 month
Success of distal radial access, Successful introduction of sheath, Day 0|Vascular access complications (other than occlusion and bleeding), Surgical complications or clinically important vascular access complications, Day 0|Puncture time, Time from skin puncture to successful placement of wire into the artery, Day 0|R...
null
NHS National Waiting Times Centre Board
MC Zuiderzee
ALL
ADULT, OLDER_ADULT
null
40
OTHER
OBSERVATIONAL
Observational Model: |Time Perspective: p
18-WS-0182|245250
2019-01-01
2020-12-31
2020-12-31
2018-12-28
null
2021-03-09
University of Glasgow/Golden Jubilee Research Foundation, Glasgow, G12 8QQ, United Kingdom
null
{}
NCT02588079
Internet-Based Cognitive Behavioral Therapy for Children With Dental Anxiety
https://clinicaltrials.gov/study/NCT02588079
null
COMPLETED
The purpose of this study is to determine whether internet-based cognitive behavioral therapy (ICBT) is effective in the treatment of children and adolescents with dental anxiety. The investigators hypothesis is that children and adolescents who have been offered ICBT show significant better performance on outcome meas...
NO
Dental Anxiety
BEHAVIORAL: Internet-based cognitive behavioral therapy
Picture guided behavioral approach test, child version, Measures changes in self-estimated ability to manage 17 dental situations, showing realistic images from dental care., post treatment(12 weeks), and follow up (12 months after posttreatment)|Picture guided behavioral approach test, parent version, Measures changes...
Self-Efficacy Questionnaire for Phobic Situations ( dentistry adapted version ), Measure changes in childs dentistry related self efficacy, post treatment(12 weeks), and follow up (12 months after posttreatment)|Childrens Fear Survey Schedule - Dental Subscale (child version), Measures changes in the childs dental anxi...
Parental Self-Efficacy Questionnaire for Dental Anxiety, Measure changes in dentistry related parental self efficacy, post treatment(12 weeks), and follow up (12 months after posttreatment)|Childrens Negative Cognitions in Dentistry, Measure changes in childrens dentistry related negative thoughts., post treatment(12 w...
Karolinska Institutet
null
ALL
CHILD
null
33
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
KIPED20151008
2015-10
2023-12-31
2023-12-31
2015-10-27
null
2024-02-14
Department of Dental Medicine, Stockholm, Huddinge, 14104, Sweden
null
{ "Internet-based cognitive behavioral therapy": [ { "intervention_type": "BEHAVIORAL" } ] }
NCT00717379
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
https://clinicaltrials.gov/study/NCT00717379
null
COMPLETED
To compare the efficacy and safety of Tacrolimus in combination with MMF and Steroids in two regimens of steroid in an adult kidney transplanted population.
NO
Kidney Transplantation|Kidney Failure, Chronic|Renal Insufficiency, Chronic
DRUG: Tacrolimus|DRUG: Mycophenolate Mofetil|DRUG: Methylprednisolone or equivalent|DRUG: Prednisone
Incidence and time to first biopsy-proven acute rejection, 6 months
Overall frequency of acute rejection episodes within 6 months post transplantation, 6 months|Severity of biopsy proven acute rejections (BANFF criteria) within 6 months post transplantation, 6 months|Incidence of and time to first corticosteroid-resistant acute rejection, 6 months|Subject and graft survival, 6 months
null
Astellas Pharma Inc
null
ALL
ADULT, OLDER_ADULT
PHASE4
50
INDUSTRY
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
PRG-EC-2R01
2007-05
2008-10
2008-10
2008-07-17
null
2009-04-15
Moscow, 115446, Russian Federation|Moscow, 119992, Russian Federation|Moscow, 123182, Russian Federation|Omsk, 644112, Russian Federation|St. Petersburg, 197110, Russian Federation|Volzskii, 404120, Russian Federation
null
{ "Tacrolimus": [ { "intervention_type": "DRUG", "description": "Tacrolimus", "name": "Tacrolimus", "synonyms": [ "Anhydrous Tacrolimus", "Tacrolimus, anhydrous", "FR900506", "Astagraf XL", "FR 900506", "Tacrolimus", "Prograft", ...
NCT01294579
Ofatumumab and Bendamustine Followed by Maintenance Ofatumumab for Rituximab Relapsed Indolent B-cell Non-Hodgkins Lymphoma (B-NHL)
https://clinicaltrials.gov/study/NCT01294579
null
COMPLETED
The purpose of this phase II open label study was is to evaluate the safety and efficacy of ofatumumab and bendamustine followed by maintenance ofatumumab in subjects with indolent B-NHL who had relapsed after Rituximab treatment. A maximum of 53 subjects at least 18 years old with Small lymphocytic, lymphoplasmacytic,...
YES
Lymphoma, Non-Hodgkin
BIOLOGICAL: Ofatumumab|DRUG: Bendamustine
Complete Remission (CR) Rate of Induction Therapy After Cycle 6 (28 Days) (FAS), Complete response (CR) included all of the following: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. All target nodes had to have regressed to ≤ 1.5cm in the lo...
Overall Response Rate (ORR) During Induction Phase After Cycle 6 (FAS), The overall response = CR (defined in Primary Outcome) + Partial Response (PR) which required all of the following: > or = to 50% decrease from baseline in target nodules; > or = to 50% decrease in hepatic/splenic nodules and no increase in liver o...
null
Novartis Pharmaceuticals
null
ALL
ADULT, OLDER_ADULT
PHASE2
49
INDUSTRY
INTERVENTIONAL
Allocation: |Intervention Model: |Masking: NONE|Primary Purpose: TREATMENT
114612
2011-05-17
2016-12-20
2016-12-20
2011-02-11
2018-08-09
2018-08-09
Novartis Investigative Site, Chandler, Arizona, 85224, United States|Novartis Investigative Site, Burbank, California, 91505, United States|Novartis Investigative Site, Fresno, California, 93720, United States|Novartis Investigative Site, Oxnard, California, 93030, United States|Novartis Investigative Site, Aurora, Col...
null
{ "Ofatumumab": [ { "intervention_type": "BIOLOGICAL", "description": "Ofatumumab", "name": "Ofatumumab", "synonyms": [ "Arzerra", "Ofatumumab", "Kesimpta", "HuMax-CD20, 2F2", "Ofatumumabum", "HuMax-CD20", "Arzerra", "Ofatumum...
NCT05193279
Safety and Immunogenicity of SCB-2019 in Children <18 Years of Age
https://clinicaltrials.gov/study/NCT05193279
null
WITHDRAWN
This is a phase 2/3, randomized, controlled study to assess the reactogenicity, safety and immunogenicity of adjuvanted recombinant SARS-CoV-2 trimeric S-protein subunit vaccine (SCB-2019), when administered as 2-dose vaccination series in children below 18 years of age.
NO
COVID-19
BIOLOGICAL: Candidate vaccine, SCB-2019
Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years, and < 2 years), based on safety, Proportion of subjects with solicited local and systemic adverse events, 7 days after dose 1 (Day 1-7)|Phase 2, select optimal dose level of SCB-2019 vaccine by age cohort (5-11 years, 2-4 years...
Phase 3, non-inferiority (SCR difference) of SARS-CoV-2 nAb titers of SCB-2019 vaccine when given to participants 5 to < 12 years as compared to young adults (18 to < 25 years), Proportion of participants achieving seroconversion for SARS-CoV-2 nAb after 2 doses of SCB-2019 vaccine in participants 5 to < 12 years minus...
null
Clover Biopharmaceuticals AUS Pty Ltd
null
ALL
CHILD
PHASE2|PHASE3
0
INDUSTRY
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
CLO-SCB-2019-007
2022-10-05
2022-12-15
2022-12-15
2022-01-14
null
2023-03-24
Clínica de la Costa Ltda, Barranquilla, 080020, Colombia|Centro de Estudios en Infectología Pediátrica S.A.S. - CEIP S.A.S., Cali, Colombia
null
{ "SCB-2019": [ { "intervention_type": "BIOLOGICAL", "description": "Candidate vaccine, SCB-2019", "name": "SCB-2019", "synonyms": [ "SCB-2019", "" ], "drugbank_id": "DB15805", "generic_names": [ "SCB-2019" ], "wikipedia_url": "https://...
NCT00770679
Effects of Statins on Lower Extremity Arterial Function Assessed by Magnetic Resonance Imaging
https://clinicaltrials.gov/study/NCT00770679
null
TERMINATED
Cholesterol-lowering drugs called statins improve the functioning of the endothelium, and help prevent heart disease. The investigators are testing whether statins improve endothelial function more in the arteries that have worse endothelium to begin with. One of the functions of the endothelium is to help control how ...
YES
Diabetes
DRUG: lipitor
Mean Change in Low Density Lipoprotein (LDL), Serum LDL, mg/dL (baseline LDL-follow-up LDL), Change from baseline to follow-up, up to 5 weeks|Change in Endothelial Function as Measured on MRI in the Arms, chance from baseline to end of study, up to 5 weeks|Change in Endothelial Function as Measured on MRI in the Legs, ...
null
null
Johns Hopkins University
Pfizer
ALL
ADULT, OLDER_ADULT
null
16
OTHER
INTERVENTIONAL
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
NA00002253
2008-06
2012-07
2012-07
2008-10-10
2017-09-13
2017-09-13
Harry SIlber, MD, Baltimore, Maryland, 21224, United States
null
{ "Atorvastatin": [ { "intervention_type": "DRUG", "description": "lipitor", "name": "Atorvastatin", "synonyms": [ "atorvastatine", "Atorvastatin Calcium Anhydrous", "Atorvastatin Calcium Trihydrate", "Atorvastatin Calcium", "Sortis", "atorva...
NCT01990079
Use of Technological Advances to Prevent Smoking Relapse Among Smokers With PTSD
https://clinicaltrials.gov/study/NCT01990079
QUIT4EVER
COMPLETED
The primary goal of the study is to evaluate the use of a new smart phone application in preventing relapse to smoking among people with PTSD. The technology intervention will combine a mobile system to reward non-smoking, smoking cessation counseling, smoking cessation medications, and use of the smart phone app. The ...
NO
PTSD|Smoking
DRUG: Bupropion|DRUG: nicotine replacement therapy|OTHER: Smoking cessation counseling|BEHAVIORAL: mobile contingency management|OTHER: Stay Quit Coach
smoking, self-report, Participants self-report of smoking in the past seven days will be measured at the end of the treatment intervention, and at 3 and 6-month follow-up contacts., 6 months follow-up
saliva cotinine, For participants reporting smoking abstinence at 3 and 6-months post treatment follow-ups, we will bio-verify smoking abstinence by collecting saliva samples that will be used to determine salivary cotinine levels., 6 months
null
Duke University
null
ALL
ADULT, OLDER_ADULT
null
15
OTHER
INTERVENTIONAL
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Pro00048990
2013-12
2015-08
2015-08
2013-11-21
null
2015-09-17
Duke University Medical Center, Durham, North Carolina, 27706, United States
null
{ "Bupropion": [ { "intervention_type": "DRUG", "description": "Bupropion", "name": "Bupropion", "synonyms": [ "Bupropion", "Bupropion Hydrochloride", "Forfivo", "Bupropion, (+-)-Isomer", "Amfebutamone", "Quomen", "Zyntabac", ...
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