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NCT02590887

Safety and Efficacy of a Drink Containing Lupine Protein Hydrolysates on the Immune, Oxidative and Metabolic Status

https://clinicaltrials.gov/study/NCT02590887

COMPLETED

The purpose of this study is to determine the health effects of the 4 weeks daily intake of a drink manufactured from lupine protein hydrolysates in healthy volunteers. For that, blood markers of inflammation, oxidative stress, carbohydrate, lipid, protein and liver metabolism, together with general hematology and blood coagulation will be assessed at baseline time (day 0) and after drink ingestion (day +14 and +28).

NO

Healthy Volunteers

DIETARY_SUPPLEMENT: Drink manufactured from lupine peptides

Assessment of the change from baseline of the plasma total antioxidant activity, Plasma total antioxidant activity, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma superoxide dismutase activity, Plasma superoxide dismutase activity, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma catalase activity, Plasma catalase activity, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma gluthathione peroxidase activity, Plasma gluthathione peroxidase activity, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma gluthathione reductase activity, Plasma gluthathione reductase activity, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of C reactive protein, Plasma levels of C reactive protein, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of immunoglobulins, plasma levels of immunoglobulin A, immunoglobulin E, immunoglobulin G and immunoglobulin M, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of complement, plasma levels of C3 and C4, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the cytokines production in peripheral blood mononuclear cells, Supernatant levels of Interleukin (IL-1)beta, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12, IL-13, IL-17, IL-22, IFNgamma and Tumour necrosis factor (TNF)-alpha, day 0 (baseline), +14, +28, +42

Assessment of the change from baseline of the plasma levels of glucose, Plasma levels of glucose, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of haematological markers, Haemogram, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of homocysteine, Plasma levels of homocysteine, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of insulin, Plasma levels of insulin, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of triglycerides, Plasma levels of triglycerides, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of cholesterol, Plasma levels of cholesterol, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of Low Density Lipoprotein (LDL) cholesterol, Plasma levels of LDL cholesterol, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of High Density Lipoprotein (HDL) cholesterol, Plasma levels of HDL cholesterol, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of total proteins, Plasma levels of total proteins, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of urea, Plasma levels of urea, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of creatinine, Plasma levels of creatinine, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of alkaline phosphatase, Plasma levels of alkaline phosphatase, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of Alanine Aminotransferase (ALT), Plasma levels of ALT, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of Aspartate Aminotransferase (AST), plasma levels of AST, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the plasma levels of Gamma-Glutamyltransferase (GGT), plasma levels of GGT, day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the gene expression of antioxidant enzymes in peripheral blood mononuclear cells, Messenger Ribonucleic Acid (mRNA) expression of superoxide dismutase, Catalase, Gluthathione peroxidase, Gluthathione reductase and inducible nitric oxide synthase (iNOS), day 0 (baseline), +14, +28, +42|Assessment of the change from baseline of the Body Mass Index, Body Mass Index, day 0 (baseline), +14, +28, +42

University of Seville

ALL

ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE

Lupine-1

2015-10

2015-12

2015-12

2015-10-29

2020-10-23

Hospital Universitario Virgen del Rocío, Seville, 41013, Spain

{ "Drink manufactured from lupine peptides": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT03487887

Secondary Care - Continuous Glucose Monitoring

https://clinicaltrials.gov/study/NCT03487887

SC-COSMO

COMPLETED

Introduction and objective: The current state of glucose monitoring includes the use of A1C, self-monitoring of blood glucose (SMBG), and continuous glucose monitoring (CGM). CGM technology has got the potential to revolutionize diabetes care in the near future striving to optimal diabetes management and tight glucose control. Until very recently, this determination could only be achieved by the attainment of multiple capillary blood glucose determinations each day and/or measuring hemoglobin A1C. Those methods are not accurate in cases of unrecognized hypoglycemia, unrecognized nighttime events or in cases of large swings in blood glucose. Our aim is to analyze the benefit of tracking patterns of glucose values by using professional CGM technology used for blinded collection of glucose data retrospectively in patients with T2DM in secondary care- diabetologist clinic.

NO

Diabetes Mellitus, Type 2

DEVICE: continuous glucose monitoring (CGM) iPro™2 Medtronic

Glycemic variability, Glycemic variability measured by continuous glucose monitor devicein individuals with type 2 diabetes mellitus in secondary care, 7 days

Hypogliaemia, Hypogliaemia measured by continuous glucose monitor device in individuals with type 2 diabetes mellitus in secondary care, 7 days

Croatian Society for Endocrinology and Diabology

Takeda

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Program CGM u bolesnika T2DM

2018-03-19

2021-08-25

2021-08-25

2018-04-04

2022-09-13

University Hospital Centre Zagreb, Zagreb, 10 000, Croatia

{ "continuous glucose monitoring (CGM) iPro\u21222 Medtronic": [ { "intervention_type": "DEVICE" } ] }

NCT01120587

Videofluoroscopic of Deglutition Study of the Initiation of Pharyngeal Phase in Young Adults

https://clinicaltrials.gov/study/NCT01120587

VFD-IPP

COMPLETED

This study has as objective to characterize the start of pharyngeal phase of swallowing, in the various food consistencies and volumes, with and without the influence of verbal orders, observed on videofluoroscopy of deglutition.

NO

Young|Healthy

Fortaleza University

ALL

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

193/2006

2010-01

2010-03

2010-05

2010-05-11

2010-05-11

{}

NCT04521387

Evaluation of Clinical Efficacy of Different Injection Therapies for Treating Humeral Epicondylopathy

https://clinicaltrials.gov/study/NCT04521387

UNKNOWN

Humeral epicondylopathies are common disorders which can significantly impair upper limb function. In case of failure of rehabilitation protocol there is no evidence based second line therapy. It is common practice to perform one of the injection procedures. The biological mechanisms of these procedures are unclear, and may even be contrary. These include, but are not limited to, injections of corticosteroids, autologous platelet rich plasma (PRP) and hyaluronic acid (HA). Despite the frequent use there is much controversy about their clinical effectiveness and more evidence based data are required. The aim of the study is to compare three different injection therapies for lateral epicondylopathy. In addition, correlation between selected bioactive compounds in PRP and its clinical effectiveness will be evaluated. The study is planned as a single-center, prospective, randomized, double-blinded, controlled trial on 120 patients aged 30-60 who suffer for lateral epicondylitis. After meeting the inclusion and exclusion criteria patients will receive an injection of leukocyte-rich autologous PRP (N1), corticosteroid (N2), HA (N3) in the area of the common extensors tendon attachment, respectively. Patients from control group (N4) will get an injection of saline in the same area. All groups will be instructed how to perform everyday stretching and strengthening exercises. Evaluation of clinical effectiveness of the treatment will be based on objective measurements such as range of motion, limb girth, grip strength, X-ray and ultrasound examination and subjective measurements such as pain (VAS), functional (PRTEE, DASH, SEV, MEPS) and quality of life questionnaires (SF-36) before and during follow-up period (1, 4, 12, 24, 52 weeks). PRP samples will undergo laboratory analysis of levels of bioactive compounds including platelets, white blood cells, erythrocytes and selected growth factors and inflammatory cytokines. After data collection, the clinical effectiveness of three different injection therapies will be evaluated and statistically analyzed. Subjective and objective outcomes, safety, costs-effectiveness of three different injection therapies compared to placebo and between each other will be assessed. In addition, correlation between levels of bioactive compounds in PRP and its efficacy will be checked.

NO

Elbow Tendinopathy

PROCEDURE: injection therapy|DRUG: Platelet Rich Plasma|DRUG: Corticosteroid Injection|DRUG: Hyaluronic Acid Injection|OTHER: Placebo Injection

Change in pain level assessed by Visual Analog Scale, the change of pain level in the region of lateral or medial humeral epicondyle after treatment represented on Visual Analog Scale (VAS) scoring from 0 (no-pain) to 10 (worst imaginable pain), 0, 1, 4, 12, 24, 52 weeks|Change in functional outcome assessed by Patient-rated Tennis Elbow Evaluation, the change in the results of functional questionnaire - Patient-rated Tennis Elbow Evaluation (PRTEE), scale from 0 to 100, lower value means less disability, 0, 4, 12, 24, 52 weeks

Change in muscle strength assessed by hand held dynamometer, the forearm muscle strength and grip strength change after treatment measured by hand held dynamometer (higher load means better outcome), 0, 4, 12, 24, 52 weeks|Change in ultrasound examination image, any changes in ultrasound examination images of lateral or medial humeral epicondyle region after treatment, 0, 4, 12, 24, 52 weeks|Change in results of quality of life questionnaire SF-36, any changes in the results of The Quality of life questionnaire SF-36, scale 0-100, lower score means more disability, 0, 4, 12, 24, 52 weeks|Change in functional outcome assessed by Disabilities of the Arm, Shoulder, and Hand, the change in the results of functional questionnaire - Disabilities of the Arm, Shoulder, and Hand (DASH), scale from 0 to 100, higher scores reflects to more disability, 0, 4, 12, 24, 52 weeks|Change in functional outcome assessed by The Subjective Elbow Value, the change in the results of functional questionnaire - The Subjective Elbow Value (SEV), scale from 0 to 100%, subjective self rating of patients elbow, 100% means normal elbow, 0, 4, 12, 24, 52 weeks|Change in functional outcome assessed by Mayo Elbow Performance Score, the change in the results of functional questionnaire - Mayo Elbow Performance Score (MEPS), scale from 0 to 100, higher value indicates a better condition, 0, 4, 12, 24, 52 weeks|Change in functional outcome assessed by The Oxford Elbow Score, the change in the results of functional questionnaire - The Oxford Elbow Score, scale from 0 to 100, higher value indicates a better condition, 0, 4, 12, 24, 52 weeks

Rate of adverse events, collecting information about any adverse events related with treatment, 0, 1, 4, 12, 24, 52 weeks|Comparison of treatment cost-effectiveness, comparison of different methods total treatment costs from intervention to complete recovery, 52 weeks

Wroclaw Medical University

ALL

ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

DZ-4000-218/19

2021-02-01

2022-05-01

2022-05-31

2020-08-20

2022-03-11

Sport Division, Wroclaw Medical University, Wrocław, Woj. Dolnośląskie, 51-618, Poland

{ "injection therapy": [ { "intervention_type": "PROCEDURE" } ], "Platelet Rich Plasma": [ { "intervention_type": "DRUG" } ], "Corticosteroid Injection": [ { "intervention_type": "DRUG" } ], "Hyaluronic acid": [ { "intervention_type": "DRUG", "description": "Hyaluronic Acid Injection", "name": "Hyaluronic acid", "synonyms": [ "Hyaluronan", "Hyaluronic acid", "Hyaluronate" ], "drugbank_id": "DB08818", "generic_names": [ "Hyaluronic acid" ] } ], "Placebo Injection": [ { "intervention_type": "OTHER" } ] }

NCT02675387

Efficacy of External Cold and a Vibrating Device in Reducing Discomfort of Dental Injections in Children

https://clinicaltrials.gov/study/NCT02675387

UNKNOWN

Children in their seventh year of life (age range of 6 to 7 years) will be included in the study. All children included in the study would have to classified according to the Wright behavior classification as potentially co-operative and rated as per the Frankl behavior rating scale as positive (++) Group A and negative (-) Group B . All children included must have had no prior experience of dental anesthesia and must have at least one tooth requiring restorative procedure on either side of the maxillary arch. Intervention Description 1. Regular Anesthesia All the subjects received local anesthesia injection in maxillary arch as is commonly practiced in dental clinics. Information obtained before assignment of intervention or standard care included age, gender, type of injection given alongside the vibration device will be recorded beforehand. During the delivery of anesthesia for all the groups, anticipated and actual pain will be recorded to show the impact of anxiety on the experience of participants. During the entire process, all participants will use standard needles with confirmed specification to control for any potential confounders 2. Buzzy® The use of the external cold and a vibrating Device will follow the manufacturers recommendations to ensure that normal clinical scenario is created.

NO

Pain

DEVICE: Buzzy|DRUG: 2%Lidocaine

Pain of injection ( Wong Baker Face Pain Scale), Pain felt on injection measured using the Wong Baker Face Pain Scale, 0 min - at the time of injection|Pain of injection ( Wong Baker Face Pain Scale), Pain felt measured using the Wong Baker Face Pain Scale, 5 min after the injection|Pain of injection ( Wong Baker Face Pain Scale), Pain felt measured using the Wong Baker Face Pain Scale, 30 min after the injection

Behavior ( Frankl behavior rating scale), Behavior measured using the Frankl behavior rating scale, 5min before procedure, 5 min after completion of procedure

Riyadh Colleges of Dentistry and Pharmacy

ALL

CHILD

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT

FPGRP/43535001/163

2015-10

2017-03

2017-06

2016-02-05

2016-02-05

Riyadh Colleges of Dentistry and Pharmacy, Riyadh, Al Riyadh, 11681, Saudi Arabia

{ "Buzzy": [ { "intervention_type": "DEVICE" } ], "2%Lidocaine": [ { "intervention_type": "DRUG" } ] }

NCT00004787

Phase II Pilot Study of Granulocyte Colony-Stimulating Factor for Inherited Bone Marrow Failure Syndromes

https://clinicaltrials.gov/study/NCT00004787

COMPLETED

OBJECTIVES: I. Assess the efficacy of recombinant human granulocyte colony-stimulating factor (G-CSF) in raising the absolute neutrophil count, platelet count, and hemoglobin level in patients with inherited bone marrow failure syndromes. II. Assess the efficacy of a reduced maintenance dose in patients who respond to daily G-CSF. III. Assess the toxic effects of G-CSF in these patients. IV. Measure bone marrow progenitor colonies before and after G-CSF. V. Measure CD34-positive cells in marrow and blood before and after G-CSF using flow cytometry and immunohistochemistry.

NO

Shwachman Syndrome|Fanconis Anemia|Dyskeratosis Congenita|Thrombocytopenia

DRUG: filgrastim

National Center for Research Resources (NCRR)

James Whitcomb Riley Hospital for Children

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2

NIH

INTERVENTIONAL

Allocation: |Intervention Model: |Masking: |Primary Purpose: TREATMENT

199/11877|UTMB-416

1994-12

2000-02-25

2005-06-24

{ "Filgrastim": [ { "intervention_type": "DRUG", "description": "filgrastim", "name": "Filgrastim", "synonyms": [ "Granulocyte Colony Stimulating Factor", "Nivestym", "Granulocyte Colony-Stimulating Factor", "Filgrastim-aafi", "R metHuG CSF", "G-CSF Recombinant, Human Methionyl", "Fraven", "Recombinant Methionyl Human Granulocyte Colony Stimulating Factor", "Granix", "G-CSF", "Tbo Filgrastim", "Topneuter", "Filgrastim-sndz", "Zarxio", "Tbo-filgrastim", "R-metHuG-CSF", "Recombinant Methionyl Human G-CSF", "Tbo-Filgrastim", "Recombinant-Methionyl Human Granulocyte Colony-Stimulating Factor", "Filgrastim", "G CSF Recombinant, Human Methionyl", "Neupogen" ], "medline_plus_id": "a692033", "generic_names": [ "Filgrastim" ], "mesh_id": "D006401", "drugbank_id": "DB00099", "wikipedia_url": "https://en.wikipedia.org/wiki/Filgrastim" } ] }

NCT06346587

[Trial of device that is not approved or cleared by the U.S. FDA]

https://clinicaltrials.gov/study/NCT06346587

WITHHELD

NO

[Redacted]

VRU751-C001

2024-04-04

2024-06-12

{}

NCT04630587

Longevity of Dental Fillings Utilizing 3D Printing

https://clinicaltrials.gov/study/NCT04630587

ENROLLING_BY_INVITATION

The aim of the present study is to compare the success of dental fillings prepared using 3D printing technique to those manufactured with the direct composite technique. A total of 100 adult patients will be selected from dental patients attending Kaarina Municipal Health Care Centre from October 2020. The inclusion criteria are as follows: presence of multiple cavities, fractures or cosmetic demands on bilateral permanent teeth. The restorative demand should be a class II, III or IV on first or second molars, or premolars. At least two fillings should be from the same tooth group (premolar/molar) in each patient. This will be a split-mouth study, whereby one tooth on one side will be restored using direct technique, and the contra lateral tooth restored using the indirect technique through random allocation. For both direct and indirect restorations, commercially available short-fibre reinforced composite material (Ever X Flow, GC) is used for core material (replacing dentin) and flowable composite material (Gaenial Universal Injectable, GC) for surface (replacing enamel, appr. 2mm thickness from the surface), according the manufacturer´s instructions. Clinical evaluations will be conducted immediately after the final finishing, and after 1 year, 3 years and 5 years. The evaluation will be based on the United States Public Health Service (USPHS) criteria. Descriptive statistics will be used to describe the frequency distributions of the evaluated criteria. To analyse the failure rate for direct vs. indirect restorations, 2x2 tables will be created. Non-parametric statistical procedures will be used due to ordinally structured data for the assessment of the restorations. Mann-Whitney U-test will be used to explore significant differences at different time points between direct and indirect restorations.

NO

Dental Restoration Failure of Marginal Integrity|Dental Caries

PROCEDURE: Indirect restorations

The United States Public Health Service (USPHS) criteria; changes during the follow-up period, The USPHS criteria include the following evaluations: retention, postoperative sensitivity, secondary caries, colour match, anatomical form, marginal discoloration, marginal adaptation, and surface texture. This clinical assessment method results in ordinally structured data for the outcome variables (A, Alpha = excellent result; B, Bravo = acceptable result; C, Charlie = unacceptable, replacement of the restoration necessary)., baseline, and 1 year, 3 years and 5 years after baseline

University of Oulu

University of Helsinki|Oulu University Hospital|University of Turku|University of Eastern Finland

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

2924410-5

2020-09-15

2026-03-31

2026-12-31

2020-11-16

2020-11-16

Research Unit of Oral Health Sciences, University of Oulu, Oulu, 90014, Finland

{ "Indirect restorations": [ { "intervention_type": "PROCEDURE" } ] }

NCT00763087

Effect of Weight-Bearing Exercise on People With Diabetes and Neuropathic Feet

https://clinicaltrials.gov/study/NCT00763087

COMPLETED

The purpose of this study is to determine if people with Diabetes Mellitus and peripheral neuropathy can increase their activity (i.e. walking or stationary biking) and leg strength without having an increase in foot problems compared to a group of people with diabetes and peripheral neuropathy that do no exercise. Our hypothesis is that the weight-bearing exercise group will achieve greater increases in weight-bearing activity (i.e., increased steps/day and cumulative load) and leg strength compared to the non-weight bearing exercise group and the non-exercising control group; and there will be no clinically meaningful difference in incidence or indicators of foot lesions between groups.

NO

Diabetes Mellitus|Peripheral Neuropathy

BEHAVIORAL: weightbearing exercise|BEHAVIORAL: nonweightbearing exercise|BEHAVIORAL: nonexercising control

daily step count, 3 months

skin breakdown, 3 months

Washington University School of Medicine

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION

06-0953

2008-09

2011-01

2011-01

2008-09-30

2017-11-07

Program in Physical Therapy, Washington University in St. Louis, Saint Louis, Missouri, 63108, United States

{ "weightbearing exercise": [ { "intervention_type": "BEHAVIORAL" } ], "nonweightbearing exercise": [ { "intervention_type": "BEHAVIORAL" } ], "nonexercising control": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00054587

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer

https://clinicaltrials.gov/study/NCT00054587

COMPLETED

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of chemotherapy plus radiation therapy with or without trastuzumab is more effective in treating breast cancer. PURPOSE: Randomized phase III trial to compare two different chemotherapy regimens plus radiation therapy with or without trastuzumab in treating women who have breast cancer that has spread to lymph nodes in the axilla (under the arm).

NO

Breast Cancer

BIOLOGICAL: Trastuzumab|DRUG: Cyclophosphamide|DRUG: docetaxel|DRUG: Epirubicin|DRUG: Fluorouracil

Progression Free Survival, 5 years from randomization

Herceptin safety, 5 years from randomization|Overall survival, 5 years from randomization

UNICANCER

FEMALE

ADULT

PHASE3

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

UC-0140/0005 - PACS 04|FRE-FNCLCC-PACS-04/0005|EU-20236|PACS04

2001-06

2009-06

2009-12

2003-02-06

2013-07-19

Centre Paul Papin, Angers, 49036, France|Centre Hospitalier dAnnecy, Annecy, 74011 Cedex, France|Institut Bergonie, Bordeaux, 33076, France|C.H. Bourg En Bresse, Bourg En Bresse, 01012, France|Centre Regional Francois Baclesse, Caen, 14076, France|Centre Jean Perrin, Clermont-Ferrand, 63011, France|Hopital Intercommunal De Creteil, Creteil, 94010, France|Centre de Lutte Contre le Cancer Georges-Francois Leclerc, Dijon, 21079, France|Institut Prive de Cancerologie, Grenoble, 38100, France|Clinique du Petit Colmouilins, Harfleur, 76700, France|Centre Hospitalier de Lagny, Lagny Sur Marne, 77405, France|Hopital Andre Mignot, Le Chesnay, 78157, France|CMC Les Ormeaux, Le Havre, 76600, France|Institut J. Paoli and I. Calmettes, Marseille, 13273, France|Centre Hospitalier Regional Metz Thionville, Metz, 57038, France|Centre Hospitalier General Andre Boulloche, Montbeliard, 25209, France|Centre Regional de Lutte Contre le Cancer - Centre Val dAurelle, Montpellier, 34298, France|Centre Hospitalier de Mulhouse, Mulhouse, 68051, France|Centre Regional Rene Gauducheau, Nantes-Saint Herblain, 44805, France|Hopital Avicenne, Paris, 75674, France|Clinique Saint - Pierre, Perpignan, France|CHU Poitiers, Poitiers, 86021, France|Institut Jean Godinot, Reims, 51056, France|Centre Eugene Marquis, Rennes, 35042, France|Clinique Sainte Clotilde, Sainte Clotilde, 97492, France|Centre Paul Strauss, Strasbourg, 67065, France|Hopitaux Universitaire de Strasbourg, Strasbourg, 67091, France|Institut Claudius Regaud, Toulouse, 31052, France|Institut Gustave Roussy, Villejuif, F-94805, France

{ "Trastuzumab": [ { "intervention_type": "BIOLOGICAL", "description": "Trastuzumab", "name": "Trastuzumab", "synonyms": [ "Trastuzumab qyyp", "trastuzumab-pkrb", "- OtherHerzuma", "Trastuzumab-qyyp", "Trastuzumab beta", "RHUMAB HER2", "Trastuzumab", "trastuzumab-dttb", "Herzuma", "trastuzumab-anns", "Herceptin", "Ontruzant", "beta, Trastuzumab", "trastuzumab-qyyp", "Kanjinti", "Zercepac", "Trazimera", "Ogivri", "trastuzumab-dkst" ], "medline_plus_id": "a699019", "generic_names": [ "Trastuzumab" ], "nhs_url": "https://www.nhs.uk/medicines/trastuzumab-herceptin", "mesh_id": "D000074322", "drugbank_id": "DB00072", "wikipedia_url": "https://en.wikipedia.org/wiki/Trastuzumab" } ], "Cyclophosphamide": [ { "intervention_type": "DRUG", "description": "Cyclophosphamide", "name": "Cyclophosphamide", "synonyms": [ "(+-)-Cyclophosphamide", "Cyclophosphamid", "Procytox", "NSC26271", "CPM", "Cytophosphane", "Cyclophosphamide Monohydrate", "Endoxan", "Neosar", "(+,-)-2-(bis(2-Chloroethyl)amino)tetrahydro-2H-1,3,2-oxazaphosphorine 2-Oxide Monohydrate", "N,N-Bis(2-chloroethyl)tetrahydro-2H-1,3,2-oxazaphosphorin-2-amine 2-oxide", "Ciclofosfamida", "Cyclophosphane", "NSC-26271", "Cytophosphan", "Cyclophosphamide anhydrous", "Anhydrous cyclophosphamide", "Bis(2-chloroethyl)phosphoramide cyclic propanolamide ester", "Ciclofosfamide", "(RS)-Cyclophosphamide", "(\u00b1)-2-(BIS(2-CHLOROETHYL)AMINO)TETRAHYDRO-2H-1,3,2-OXAZAPHOSPHORINE 2-OXIDE MONOHYDRATE", "B 518", "CYT", "B518", "Cytoxan", "Cyclophosphamide Anhydrous", "2-[Bis(2-chloroethylamino)]-tetrahydro-2H-1,3,2-oxazaphosphorine-2-oxide", "Cyclophosphamide, (R)-Isomer", "Sendoxan", "NSC 26271", "B-518", "Cyclophosphamidum", "Cyclophosphamide, (S)-Isomer", "Cyclophosphamide" ], "medline_plus_id": "a611044", "generic_names": [ "Cyclophosphamide" ], "mesh_id": "D019653", "drugbank_id": "DB00531" } ], "Docetaxel": [ { "intervention_type": "DRUG", "description": "docetaxel", "name": "Docetaxel", "synonyms": [ "Docetaxel Hydrate", "N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol", "Taxotere", "Docefrez", "Taxoltere Metro", "Docetaxol", "RP-56976", "RP56976", "Docetaxel anhydrous", "TXL", "Docetaxel Trihydrate", "N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetylpaclitaxel", "Docetaxel", "RP 56976", "N-Debenzoyl-N-tert-butoxycarbonyl-10-deacetyltaxol", "N Debenzoyl N tert butoxycarbonyl 10 deacetyltaxol", "Docetaxel Anhydrous", "NSC 628503" ], "medline_plus_id": "a696031", "generic_names": [ "Docetaxel" ], "mesh_id": "D050257", "drugbank_id": "DB01248" } ], "Epirubicin": [ { "intervention_type": "DRUG", "description": "Epirubicin", "name": "Epirubicin", "synonyms": [ "4'-Epiadriamycin", "EPIcell", "NSC256942", "NSC-256942", "(1S,3S)-3-GLYCOLOYL-1,2,3,4,6,11-HEXAHYDRO-3,5,12-TRIHYDROXY-10-METHOXY-6,11-DIOXO-1-NAPHTHACENYL 3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-ARABINO-HEXOPYRANOSIDE", "4'-EPI-ADRIAMYCIN", "NSC 256942", "Farmorubicine", "Epirubicina", "Ellence", "IMI28", "4'-Epi-DXR", "4' Epi Doxorubicin", "5,12-NAPHTHACENEDIONE, 10-((3-AMINO-2,3,6-TRIDEOXY-.ALPHA.-L-ARABINO-HEXOPYRANOSYL)OXY)-7,8,9,10-TETRAHYDRO-6,8,11-TRIHYDROXY-8-(HYDROXYACETYL)-1-METHOXY-, (8S-CIS)-", "Pharmorubicin", "4' Epi Adriamycin", "4' Epidoxorubicin", "Hydrochloride, Epirubicin", "Farmorubicina", "Epilem", "Farmorubicin", "4'-Epi-Doxorubicin", "Epirubicin", "4'-Epi-Adriamycin", "Epirubicine", "Epiadriamycin", "4'-Epidoxorubicin", "EPI-cell", "Epirubicinum", "IMI 28", "Epirubicin Hydrochloride", "4' Epi DXR", "Pidorubicine", "Pidorubicinum", "Pidorubicina", "4' Epiadriamycin", "EPI cell", "epirubicin-conjugated polymer micelles", "IMI-28" ], "medline_plus_id": "a603003", "generic_names": [ "Epirubicin" ], "mesh_id": "D059005", "drugbank_id": "DB00445" } ], "Fluorouracil": [ { "intervention_type": "DRUG", "description": "Fluorouracil", "name": "Fluorouracil", "synonyms": [ "5-Fluoracil", "Fluoro Uracil", "Ribofluor", "5-Fluoropyrimidine-2,4-dione", "Efudix", "Fluorouracile Dakota", "5-FU", "Neofluor", "Dakota, Fluorouracile", "Fluoroplex", "Fluoro-Uracile ICN", "Fluorouracilo Ferrer Far", "5-Fluorouracil-Biosyn", "5-FU Lederle", "Onkofluor", "5 Fluorouracil Biosyn", "Fluorouracil", "Haemato-FU", "Fluorouracilum", "5-FU Medac", "5 HU Hexal", "5-Fluracil", "Carac", "Fluoruracil", "5 FU Medac", "Fluouracil", "5 Fluorouracil", "5 FU Lederle", "Fluorouracil Monopotassium Salt", "Fluorouracilo", "5-Fluorouracil", "Fluorouracil Potassium Salt", "Haemato FU", "5-HU Hexal", "Fluorouracil-GRY", "Adrucil", "Flurodex", "Fluorouracil GRY", "Efudex", "Fluorouracil Monosodium Salt", "Fluorouracil Mononitrate", "5FU", "Fluoro Uracile ICN", "Fluracedyl" ], "medline_plus_id": "a605010", "generic_names": [ "Fluorouracil" ], "mesh_id": "D007166", "drugbank_id": "DB00544" } ] }

NCT05722587

Students Understanding and Beliefs About Pain Before and After a One-day Pain Science Education Conference: an Intervention

https://clinicaltrials.gov/study/NCT05722587

COMPLETED

The beliefs held by students lead to behaviours in response to their pain which can be both helpful or a hindrance to how they manage their pain. The one-day education event aims to educate the cohort on the contemporary scientific understanding of persistent pain using a mixture of methods. It is hoped this event will result in an improvement in the alignment of beliefs and behaviours to contemporary understanding of persistent pain. The principal aim is to evaluate the pre-post knowledge and beliefs about pain following a one-day pain education event in year 12 students, aged 16 or above.

NO

Pain, Chronic

OTHER: Pain science education

Pain Beliefs Questionnaire (PBQ), Helps to identify if participant beliefs are biomedical or biopsychosocial focussed, 12-item (Edwards et al, 1992, Walsh and Radcliffe, 2002). There are 2 scales within the PBQ: the organic beliefs scale has 8 items, with score ranges from 8-48, lower scores indicate less biomedical views and higher scores indicate more biomedical views. The psychological scale within the PBQ has 4 items with a score range of 4-24, a higher score indicates more biopsychosocial beliefs about pain and a lower score indicates less biopsychosocial beliefs., 3 months

Concept of Pain Inventory-Adult (COPI-Adult), The Concept of Pain Inventory-Adult was designed for assessing knowledge and beliefs about pain science (Pate et al, 2022). It is a 13-item questionnaire. Higher COPI-Adult scores reflect greater alignment with contemporary pain science (Total scores can range from 0-52)., 3 months

Vignette, Participants will be asked what actions they would take if they had pain with regards to medication, scans, daily activity, exercise and work either based on yes/no answers or four to five multiple choice answers. The percentage of recommendations in keeping with guidelines were measured from 0-100% with lower scores indicating intended behaviours that were not in keeping with guidelines., 3 months

Teesside University

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

2022 Oct 11360 Mankelow

2023-03-02

2023-03-02

2023-06-02

2023-02-10

2023-07-20

Teesside University, Middlesbrough, TS1 3BX, United Kingdom

{ "Pain science education": [ { "intervention_type": "OTHER" } ] }

NCT06202287

In Stroke Patients, the Relationship Between Social Participation Level, Balance, Walking, Pain, and Kinesiophobia

https://clinicaltrials.gov/study/NCT06202287

RECRUITING

The aim of this study is to detect the presence of kinesiophobia, which may affect treatment in stroke patients, and to have an idea about its relationship with kinesiophobia by examining factors such as balance, gait, pain and social participation level.

NO

Kinesiophobia|Stroke

OTHER: Balance measurements using the HUR Smart balance device, balance tests, and other surveys.

The Tampa Scale of Kinesiophobia, Scale, The Tampa Kinesiophobia Scale (TKS) is a self-reported, 17-item scale developed to measure the fear of movement. A high score indicates a high level of fear of movement, while a low score suggests negligible levels of fear of movement., baseline

Visual analogue scale, The Visual Analog Scale (VAS) is evaluated on a scale ranging from no pain to worst possible pain. The value of 0 (zero) indicates no pain, while the value of 10 (ten) indicates the most severe pain imaginable. , baseline|Functional ambulation classification (FAC), Scale, The FAC has six categories ranging from 0 (non-functional ambulation) to 5 (independent). The intermediary categories quantify levels of assistance, supervision, and independent but limited mobility., baseline|Community Integration Questionnaire, Questionnaire,The community integration questionnaire (CIQ) was designed to assess home integration, social integration and productive activity in persons with acquired brain injury. The instrument consists of 15 items and can be completed by self report or with the assistance of a family member or caregiver familiar with the persons health status and social activities. The community integration questionnaire (CIQ) was designed to assess home integration, social integration and productive activity in persons with acquired brain injury. The instrument consists of 15 items and can be completed by self report or with the assistance of a family member or caregiver familiar with the persons health status and social activities., baseline|Mini-BESTest: Balance Evaluation Systems Test, The Mini-BESTest includes four subscales: transitions/anticipatory postural control, reactive postural control, sensory orientation and stability in gait. Each item is rated on a three-point ordinal scale(0 = severe to 2 = normal).The MiniBESTest consists of 14 items, with a maximum score of 28 points, baseline|The timed up and go test, A 3-meter distance in front of the chair is designated. The patient is asked to stand up from the chair, walk this distance, and then sit down again. The elapsed time provides the result of the test. If the patient takes longer than 12 seconds to complete this test, there is a risk of falling., baseline|Tinetti balance and gait test, This test measures the patients balance and gait ability. The maximum score for the gait component is 12, and for the balance component is 16. The overall maximum score is 28. Generally, patients scoring below 19 are at a high risk of falling., baseline|VAS - Kinesiophobia Assessment, To measure motion fear, a Visual Analog Scale was used. A 10-centimeter horizontal line was drawn, ranging from 0 (no fear) at the beginning to 100 (severe fear) at the end. Participants were asked to stand up just before starting exercise and mark the intensity of their motion fear at that moment on the scale., baseline|HUR Smart balance device, In the measurement of postural balance parameters, we utilized the HUR SMARTBALANCE BTG4 device and the accompanying software, HUR SmartBalance, available in our clinic. The device, through the balance platform, enables force measurements and load distribution, while sensors detect postural changes. The HUR SmartBalance software within the device provides various balance parameters based on these values, allowing for the assessment of the patients balance, baseline

Ankara City Hospital Bilkent

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

10026499

2023-10-15

2024-01-15

2024-04-15

2024-01-11

2024-01-11

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital, Ankara, 06800, Turkey

{ "Balance measurements using the HUR Smart balance device, balance tests, and other surveys.": [ { "intervention_type": "OTHER" } ] }

NCT05043987

Dose Escalation and Expansion Study of CPO102, an Anti-claudin 18.2 ADC in Patients With Advanced Cancers

https://clinicaltrials.gov/study/NCT05043987

WITHDRAWN

This Phase 1 study will be a multicenter, single agent, dose escalation and dose expansion study conducted in patients with advanced late stage cancer (pancreatic or gastric including esophageal junction cancers) for which the investigator determines there to be no other standard of care or higher priority therapies available.

NO

Pancreatic Cancer|Gastric Cancer

DRUG: CPO102

Number of participants with dose-limiting toxicities (DLTs) during the DLT evaluation period., DLTs are assessed during the first cycle (21 days) in each cohort to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)., through study completion, an average of 3 year

Number of participants with treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship., TEAEs will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 5.0., through study completion, an average of 3 year|Number of participants with clinically significant changes in vital signs, Number of participants with clinically significant changes in vital signs, through study completion, an average of 3 year|Number of participants with clinically significant changes in clinical laboratory tests, Number of participants with clinically significant changes in clinical laboratory tests, through study completion, an average of 3 year|CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval., CPO102 pharmacokinetics: Area under the concentration time curve over the dosing interval., through study completion, an average of 3 year|CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax), CPO102 pharmacokinetics: Maximum concentration of the drug (Cmax), through study completion, an average of 3 year|CPO102 pharmacokinetics: Time to maximum concentration (Tmax), CPO102 pharmacokinetics: Time to maximum concentration (Tmax), through study completion, an average of 3 year|CPO102 pharmacokinetics: Elimination half-life (t1/2), CPO102 pharmacokinetics: Elimination half-life (t1/2), through study completion, an average of 3 year|CPO102 pharmacokinetics: Clearance (CL), CPO102 pharmacokinetics: Clearance (CL), through study completion, an average of 3 year|CPO102 Objective response rate (ORR), ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 is observed as best overall response., through study completion, an average of 3 year|CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA), CPO102 immunogenicity: Number of participants with anti-drug-antibody (ADA), through study completion, an average of 3 year

Conjupro Biotherapeutics, Inc.

CSPC Megalith Biopharmaceutical Co., Ltd.

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT

CPO102-US-1001

2022-11-16

2022-11-16

2022-11-16

2021-09-14

2023-09-07

{ "CPO102": [ { "intervention_type": "DRUG" } ] }

NCT02469987

Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

https://clinicaltrials.gov/study/NCT02469987

COMPLETED

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

NO

Healthy

DRUG: MYL-1402O|DRUG: US marketed Avastin(R)|DRUG: EU marketed Avastin(R)

Area under the plasma concentration versus time curve (AUC) for bevacizumab., Area under the plasma concentration versus time curve (AUC) for bevacizumab, pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.

Area under the plasma concentration versus time curve (AUC) for bevacizumab, Area under the plasma concentration versus time curve (AUC) for bevacizumab, pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.

Number of Participants with Adverse Events, Number of Participants with Adverse Events, up to 99 days.|Safety variable - immunogenicity, Immunogenicity, Predose day 1, and days 15, 43, 71, and 99 post infusion

Mylan Inc.

Mylan GmbH

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER

MYL-1402O-1002|2014-005621-12

2015-04

2015-10

2015-10

2015-06-12

2022-03-25

PRA Health Sciences - Early Development Services, Zuidlaren, 9471 GP, Netherlands

{ "MYL-1402O": [ { "intervention_type": "DRUG" } ], "US marketed Avastin(R)": [ { "intervention_type": "DRUG" } ], "EU marketed Avastin(R)": [ { "intervention_type": "DRUG" } ] }

NCT00560287

Non-Invasive Ventilation in Amyotrophic Lateral Sclerosis

https://clinicaltrials.gov/study/NCT00560287

UNKNOWN

Non-invasive mechanical ventilation (NIV) has been increasingly used as a treatment of chronic hypercapnic respiratory failure. Its use in patients affected by chronic obstructive pulmonary disorders is still controversial, while most of the studies performed in restrictive thoracic disorders (RTD), and in particular in neuromuscular patients, suggested alleviation of the symptoms of chronic hypoventilation in the short term, and in two small studies survival was prolonged. In the terminal phase of the disease, when the respiratory muscles became weaker it is very likely that the operators need to frequently adjust the level of inspiratory pressure in an attempt to guarantee an adequate tidal volume, so that alveolar hypoventilation may be avoided. Theoretically the use of a volume assisted ventilation may overpass this problem of frequent variations of the settings, since the provision of a fixed tidal volume may always guarantee and adequate alveolar ventilation. The primary aims of this multicenter randomized study are to evaluate the clinical efficacy, the patients tolerance and quality of life and the frequency of changing settings in a group of patients with SLS and initial chronic respiratory failure undergoing long-term NIV with Pressure Support Ventilation or Volume Assisted Ventilation.

NO

Amyotrophic Lateral Sclerosis|Chronic Respiratory Failure

DEVICE: Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers|DEVICE: Non invasive ventilation

quality of life, 1 year|tolerance to NIV, 1 year|number of hours of NIV per day, 1 year|frequency of hospital admission, 1 year|frequency of changing the ventilator settings by the operator., 1 year

survival, 1 year|diurnal and nocturnal gas exchange, 1 year|Pulmonary Function Tests (PFTs)., 1 year

Fondazione Salvatore Maugeri

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE

190H09|190H09

2008-01

2009-08

2010-08

2007-11-19

2010-03-29

Fondazione S.Maugeri, Pavia, 27100, Italy|Respiratory Unit FSM, Pavia, 27100, Italy

{ "Non invasive ventilation delivered with one of the ventilator specifically designed for NIV and given to the patient by the home care providers": [ { "intervention_type": "DEVICE" } ], "Non invasive ventilation": [ { "intervention_type": "DEVICE" } ] }

NCT02221687

The Combiotic-Study

https://clinicaltrials.gov/study/NCT02221687

GOLFIII

TERMINATED

The primary objective of this study is to demonstrate that a synbiotic formula, fed for the duration of the first year of life (infant and follow-on formula) reduces the incidence rate of episodes of infectious diarrhea in infants during the first year of life compared to a standard infant formula.

NO

Healthy Term Infants

DIETARY_SUPPLEMENT: Synbiotic formula|DIETARY_SUPPLEMENT: Control formula

(Cumulative) number of infectious diarrhea episodes per subject during the first year of life., Difference between formula groups are evaluated via incidence rate based on number of subjects. In formula-fed infants, diarrhea is defined as three or more loose or watery stools in 24 hours with or without fever or vomiting (according to WHO and ESPGHAN definition). For breast-fed infants, a change in stool consistency versus previous stool consistency is more indicative of diarrhea than stool number. Diarrhea episode is considered as ended as soon as 2 consecutive non-watery stools are observed or no stools are observed in 24 hours., one year

Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples, Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile, 4 months|Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples, Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile, 1 year|Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples, Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile, 2 years|Analysis of fecal microbiota by molecular analysis from frozen stools in planned stool samples, Levels of total lactobacilli, Lactobacillus fermentum species (and if possible the strain CECT 5716 will be quantified too), total bifidobacteria, enterobacteriaceae, clostridium difficile, 3 years|Analysis of fecal microbiota by molecular analysis from frozen stools in diarrhea samples, levels of potential pathogens causing diarrhea including rotavirus, norovirus, Salmonella enterica, Campylobacter jejuni, Clostridium difficile, Clostridium perfringens, Escherichia coli (potential pathogenic bacteria will be screened only in case of negative testing for viruses on sample collected within 72 hours after beginning of the diarrhea episode);, 1 year|Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples, short chain fatty acids (SCFA): acetate, propionate, butyrate;, 4 months|Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples, short chain fatty acids (SCFA): acetate, propionate, butyrate;, 1 year|Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples, short chain fatty acids (SCFA): acetate, propionate, butyrate;, 2 years|Fecal pH and levels of short chain fatty acids (SCFA) in planned stool samples, short chain fatty acids (SCFA): acetate, propionate, butyrate;, 3 years|Characteristics of bowel movements and stools, - assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale consistency on Bekkali scale); * dominant stool color per visit, 4 months|Characteristics of bowel movements and stools, - assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale consistency on Bekkali scale); * dominant stool color per visit, 6 months|Characteristics of bowel movements and stools, - assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale consistency on Bekkali scale); * dominant stool color per visit, 9 months|Characteristics of bowel movements and stools, - assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale consistency on Bekkali scale); * dominant stool color per visit, 1 year|Characteristics of bowel movements and stools, - assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale consistency on Bekkali scale); * dominant stool color per visit, 2 years|Characteristics of bowel movements and stools, - assessed through a 3-day diary filled in by parents * average daily number of bowel movements; * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) (using the validated scale for preterm and term infants proposed by Bekkali N, et al., 2009), and especially * average daily incidence of loose or watery stools (category A, subscale consistency on Bekkali scale); * dominant stool color per visit, 3 years|Characteristics of bowel movements during diarrhea episodes, - assessed through a diary filled in by parents during diarrhea episodes * average daily number of bowel movements per diarrhea episode; * average duration (number of days) of diarrhea episodes; * total number of days with diarrhea, within the first year of age (between V1 and V5); * (average daily) Infant Stool Form scores consistency (4-point scale), amount (4-point scale) and color (6 categories) per diarrhea episode., 1 year|Levels of fecal IgA and fecal calprotectin in planned stool samples, 4 months|Levels of fecal IgA and fecal calprotectin in planned stool samples, 1 year|Levels of fecal IgA and fecal calprotectin in planned stool samples, 2 years|Levels of fecal IgA and fecal calprotectin in planned stool samples, 3 years|Number and duration of infectious diseases, Especially: otitis media, infections of upper and lower respiratory tract and of urinary tract;, 3 years|Number and duration of fever episodes;, 3 years|Number and duration of antibiotic treatment., 3 years|Infants growth measured by anthropometric measurements, weight, size, head circumference;, 4 weeks|Infants growth measured by anthropometric measurements, weight, size, head circumference;, 4 months|Infants growth measured by anthropometric measurements, weight, size, head circumference;, 6 months|Infants growth measured by anthropometric measurements, weight, size, head circumference;, 9 months|Infants growth measured by anthropometric measurements, weight, size, head circumference;, 1 year|Infants growth measured by anthropometric measurements, weight, size, head circumference;, 2 years|Infants growth measured by anthropometric measurements, weight, size, head circumference;, 3 years|Childs behavior, Assessed through a 3-day diary filled in by parents - Average sleep duration and crying duration per 24 hours;, 4 months|Childs behavior, Assessed through a 3-day diary filled in by parents - Average sleep duration and crying duration per 24 hours;, 6 months|Childs behavior, Assessed through a 3-day diary filled in by parents - Average sleep duration and crying duration per 24 hours;, 9 months|Childs behavior, Assessed through a 3-day diary filled in by parents - Average sleep duration and crying duration per 24 hours;, 1 year|Childs behavior, Assessed through a 3-day diary filled in by parents - Average sleep duration and crying duration per 24 hours;, 2 years|Childs behavior, Assessed through a 3-day diary filled in by parents - Average sleep duration and crying duration per 24 hours;, 3 years|Minor gastrointestinal disorders (digestive tolerance), Assessed through a 3-day diary filled in by parents - average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);, 4 months|Minor gastrointestinal disorders (digestive tolerance), Assessed through a 3-day diary filled in by parents - average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);, 6 months|Minor gastrointestinal disorders (digestive tolerance), Assessed through a 3-day diary filled in by parents - average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);, 9 months|Minor gastrointestinal disorders (digestive tolerance), Assessed through a 3-day diary filled in by parents - average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);, 1 year|Minor gastrointestinal disorders (digestive tolerance), Assessed through a 3-day diary filled in by parents - average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);, 2 years|Minor gastrointestinal disorders (digestive tolerance), Assessed through a 3-day diary filled in by parents - average daily vomiting, regurgitation/reflux, flatulence, constipation (according to WHO definition);, 3 years|Suitability for daily use, Assessed through a 3-day diary filled in by parents - average daily consumption: drinking amounts and formula acceptance;, 4 months|Suitability for daily use, Assessed through a 3-day diary filled in by parents - average daily consumption: drinking amounts and formula acceptance;, 6 months|Suitability for daily use, Assessed through a 3-day diary filled in by parents - average daily consumption: drinking amounts and formula acceptance;, 9 months|Suitability for daily use, Assessed through a 3-day diary filled in by parents - average daily consumption: drinking amounts and formula acceptance;, 1 year|Suitability for daily use, Assessed through a 3-day diary filled in by parents - average daily consumption: drinking amounts and formula acceptance;, 2 years|Suitability for daily use, Assessed through a 3-day diary filled in by parents - average daily consumption: drinking amounts and formula acceptance;, 3 years|Adverse events (AE), Assessed through a 3-day diary filled in by parents - Number of events, number of subjects showing adverse events, intensity and relationship of AE., 4 months|Adverse events (AE), Assessed through a 3-day diary filled in by parents - Number of events, number of subjects showing adverse events, intensity and relationship of AE., 6 months|Adverse events (AE), Assessed through a 3-day diary filled in by parents - Number of events, number of subjects showing adverse events, intensity and relationship of AE., 9 months|Adverse events (AE), Assessed through a 3-day diary filled in by parents - Number of events, number of subjects showing adverse events, intensity and relationship of AE., 1 year|Adverse events (AE), Assessed through a 3-day diary filled in by parents - Number of events, number of subjects showing adverse events, intensity and relationship of AE., 2 years|Adverse events (AE), Assessed through a 3-day diary filled in by parents - Number of events, number of subjects showing adverse events, intensity and relationship of AE., 3 years|Number and duration of fever episodes;, 1 year|Number and duration of antibiotic treatment., 1 year|Number and duration of infectious diseases, Especially: otitis media, infections of upper and lower respiratory tract and of urinary tract;, 1 year

Microbiota results, Phyla and families of bacteria in planned stools using 16S taxonomical metasequencing compared to the control formula in a sub-group of 96 infants only, 1 year|Urinary D-Lactate and creatinine, To assess change in the urinary lactate and creatinine (in a subgroup of 96 infants only) via ratio after 3 months of consumption of the supplemented infant formula, compared to the control formula, 4 weeks|Urinary D-Lactate and creatinine, To assess change in the urinary lactate and creatinine (in a subgroup of 96 infants only) via ratio after 3 months of consumption of the supplemented infant formula, compared to the control formula, 4 months|Microbiota results, Phyla and families of bacteria in planned stools using 16S taxonomical metasequencing compared to the control formula in a sub-group of 96 infants only, 4 months|Microbiota results, Phyla and families of bacteria in planned stools using 16S taxonomical metasequencing compared to the control formula in a sub-group of 96 infants only, 2 years|Microbiota results, Phyla and families of bacteria in planned stools using 16S taxonomical metasequencing compared to the control formula in a sub-group of 96 infants only, 3 years

HiPP GmbH & Co. Vertrieb KG

Biofortis Mérieux NutriSciences

ALL

CHILD

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: PREVENTION

505564 - PEC10561

2014-08

2019-04

2021-04

2014-08-20

2022-01-20

Elie JABBOUR, Gemozac, Charente-Maritime, 17260, France|Christophe VIEL, La Rochelle, Charente-Maritime, 17000, France|C.I.C Pédiatrique - C.H.U. de Grenoble - Hôpital Couple-Enfant, Grenoble, Isère, 38043, France|C.I.C pédiatrique - C.H.U. de Nantes - Hôpital Mère-Enfant, Nantes, Loire-Atlantique, 44093, France|Alain PALOMBA, Angers, Maine-et-Loire, 49000, France|Christophe RONDEAU, Angers, Maine-et-Loire, 49000, France|Damien GODIN, Angers, Maine-et-Loire, 49000, France|Daniel GOMBAUD, Angers, Maine-et-Loire, 49000, France|Jean-François FOUCAULT, Angers, Maine-et-Loire, 49000, France|Michel LAMBERT, Angers, Maine-et-Loire, 49000, France|Nolwenn RONCERAY, Angers, Maine-et-Loire, 49000, France|Philippe REMAUD, Angers, Maine-et-Loire, 49000, France|Pierre-André FERRAND, Angers, Maine-et-Loire, 49000, France|Vanessa BERNAND, Angers, Maine-et-Loire, 49000, France|Francisco MARTINEZ-CORTES, Angers, Maine-et-Loire, 49100, France|Damien GUILLON, Angers, Maine-et-Loire, 49120, France|Christine REGIMBART, Becon Les Granits, Maine-et-Loire, 49370, France|Antoine LEPELLETIER, Montreuil, Maine-et-Loire, 49460, France|Benoit DAGUZAN, Segre, Maine-et-Loire, 49500, France|Didier NOURRY, Tierce, Maine-et-Loire, 49125, France|Philippe IGIGABEL, Tierce, Maine-et-Loire, 49125, France|Alain BATY, Laval, Mayenne, 53000, France|Christian DUROY, Laval, Mayenne, 53000, France|François RICHARD, Laval, Mayenne, 53000, France|Patrick ROBERT, Laval, Mayenne, 53000, France

{ "Synbiotic formula": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Control formula": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT02394587

MBSR for Pain Catastrophizing in SCD

https://clinicaltrials.gov/study/NCT02394587

COMPLETED

Significance: The purpose of this exploratory study is to test the feasibility, accessibility, and effects of a mindfulness-based stress reduction program (MBSR) on reducing pain catastrophizing in persons with sickle cell disease (SCD) and chronic pain. One of the most difficult symptoms for SCD patients to manage is chronic pain. Approximately one-third of SCD patients experience chronic pain, which is associated with pain catastrophizing. Pain catastrophizing is a negative mental state toward pain stimuli and pain experience, and is associated with increased pain severity, pain interference, and lower social functioning, physical functioning, and mental health. There have been no psychobehavioral intervention studies that have attempted to alter the experience of pain catastrophizing in persons with SCD. MBSR is a complementary group-based therapy that emphasizes nonjudgmental awareness of thoughts, feelings, and bodily sensations. With no pharmacological or non-pharmacological treatment for catastrophizing in persons with SCD, MBSR offers a potential solution to this highly significant problem for both SCD patients and providers. This project will be the first randomized controlled trial (RCT) of MBSR to reduce pain catastrophizing, and improve quality of life for SCD patients with chronic pain. Methods: This study will enroll 60 adult patients with SCD and chronic pain from the Duke Adult Sickle Cell Clinic. Patients will be randomized to a MBSR or wait-listed control group. The MBSR group will complete a 6- week, group-based telephonic MBSR program that is administered by a certified MBSR clinician once a week for 90 minutes. MBSR feasibility, acceptability, and effects on pain catastrophizing will be assessed by questionnaires at baseline, week 1, 3, and 6 in both groups. At the end of week 6, 10 randomly selected MBSR participants will complete semi-scripted telephone interviews to help assess intervention acceptability, and the wait-listed control condition will be offered the same MBSR intervention.

NO

Anemia, Sickle Cell

BEHAVIORAL: Mindfulness-based Stress Reduction

Acceptability of MBSR as measured by semi-scripted telephone assessments, Acceptability of the intervention will be assessed by semi-scripted telephone or in-person interviews. The semi-scripted interview will focus on MBSR patients reflections and expectations of the program, the mindfulness skills they found useful and in what ways, the skills they found less useful and or difficult to implement, and on any changes in thoughts or actions that resulted from the application of the MBSR techniques., 6 weeks|Feasibility of MBSR as measured by recruitment, attrition rates, and practice logs, Feasibility of the intervention will be assessed by recruitment and attrition rates, number of daily mindfulness logs completed, and average number of weekly minutes of mindfulness practice as recorded in logs. Feasibility data will be obtained for both the intervention and control subjects who elect to receive the intervention after the intervention is complete with the MBSR group. However, data will not be analyzed together because the delay to receiving the intervention would affect the results. Data from the control group will be used to help inform future studies., 6 weeks

Change in Pain Catastrophizing as measured by the Pain Catastrophizing Scale, Descriptive statistics will be used to summarize the pain catastrophizing at week1, 3, and 6, as measured by the Pain Catastrophizing Scale. Trajectory analyses, using a type of mixed effects model known as a random coefficients regression model for repeated measurement, will be conducted to evaluate and compare the rate and pattern of change over the 6 weeks in the MBSR and wait-listed control groups for pain catastrophizing., baseline, week 1, week 3, and week 6|Change in Mindfulness as measured by the Mindful Attention Awareness Scale, Descriptive statistics will be used to summarize mindfulness at week1, 3, and 6, as measured by the Mindful Attention Awareness Scale. Trajectory analyses, using a type of mixed effects model known as a random coefficients regression model for repeated measurement, will be conducted to evaluate and compare the rate and pattern of change over the 6 weeks in the MBSR and wait-listed control groups for pain catastrophizing., baseline, week 1, week 3, and week 6

Duke University

National Institutes of Health (NIH)|National Institute of Nursing Research (NINR)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE

Pro00052848|F31NR014954-01

2015-04

2016-01

2016-01

2015-03-20

2017-12-29

Duke University School of Nursing, Durham, North Carolina, 27701, United States

{ "Mindfulness-based Stress Reduction": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01214187

Study of Inhaled Carbon Monoxide to Treat Idiopathic Pulmonary Fibrosis

https://clinicaltrials.gov/study/NCT01214187

COMPLETED

The purpose of this study is to determine whether low concentration inhaled carbon monoxide is effective in treating idiopathic pulmonary fibrosis.

YES

Idiopathic Pulmonary Fibrosis

DRUG: inhaled carbon monoxide|OTHER: Oxygen

Serum MMP7 Level, The primary study endpoint was the change in MMP7 serum concentration (ng/ml) from baseline to 12 weeks. Serum MMP7 concentrations in peripheral blood are easily measureable and reflect changes in the alveolar microenvironment. Thus, we have chosen to study mean serum MMP7 concentrations after three months of CO treatment as a surrogate biomarker of the effect of inhaled CO administration on disease progression., Baseline to Week 12

Total Lung Capacity % Predicted Values (TLC), Total lung capacity % predicted values (TLC) is a major clinical determinant of restrictive lung disease in practice, with TLC measurement below the 5th percentile of the predicted value indicative of a restrictive ventilatory defect, Baseline to Week 12|Diffusing Capacity for Carbon Monoxide (DLCO) % Predicted Values, Interstitial changes associated with IPF can worsen diffusing capabilities across the alveolar-capillary membrane. As a result, diffusing capacity of carbon monoxide is an important outcome to assess architectural distortion and resultant decrements in diffusing capabilities, Baseline to Week 12|Six Minute Walk Distance, The six minute walk distance is commonly used both in research studies and in clinical practice as a measure of functional capabilities, and changes in six minute walk distance and oxygen use during testing over time often reflect clinically relevant disease progression. We will measure the distance travelled during six minutes (meters) in accordance with published guidelines, Baseline to Week 12|St Georges Respiratory Questionnaire, St. Georges Respiratory Questionnaire (SGRQ) is a validated self-reported instrument. In this instrument, scores range from 0 to 100, with higher scores reflective of worse quality of life., Baseline to Week 12

Brigham and Womens Hospital

National Heart, Lung, and Blood Institute (NHLBI)|University of California, San Francisco|University of Chicago|University of Illinois at Chicago|University of Michigan|Columbia University|Tulane University|University of Washington

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: TREATMENT

1U01HL105371|1U01HL105371

2011-07

2014-10

2015-04

2010-10-04

2017-06-14

2017-06-14

University of California San Francisco, San Francisco, California, 94143, United States|University of Illinois Chicago, Chicago, Illinois, 60612, United States|University of Chicago, Chicago, Illinois, 60637, United States|Tulane University, New Orleans, Louisiana, 70112, United States|Brigham and Womens Hospital, Boston, Massachusetts, 02115, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|Columbia University, New York, New York, 10032, United States|University of Washington, Seattle, Washington, 98195, United States

{ "Carbon monoxide": [ { "intervention_type": "DRUG", "description": "inhaled carbon monoxide", "name": "Carbon monoxide", "synonyms": [ "Carbon monoxide", "Carboneum oxygenisatum" ], "drugbank_id": "DB11588", "generic_names": [ "Carbon monoxide" ] } ], "Oxygen": [ { "intervention_type": "OTHER" } ] }

NCT05495087

IHT for Mild Cognitive Impairment

https://clinicaltrials.gov/study/NCT05495087

RECRUITING

This phase I clinical trial will examine the safety and efficacy of intermittent hypoxia training (IHT) for up to 12 weeks to treat subjects with mild cognitive impairment (MCI).

NO

Mild Cognitive Impairment|Memory Impairment

DEVICE: IHT Treatment|OTHER: Sham-IHT Control

Overall Cognitive Function, Change in scores or points (from 0 to 30) in Mini-mental State Examination. Higher scores indicate better testing performance or function., Change from baseline 5-week, 8-week, and up to 12-week intervention|Attention and Short-term Memory, Change in scores or points in California-Verbal Learning Test - 2nd edition. Immediate Free-Recall (FR), short-delay FR and long-delay FR for words. More FR words indicate better testing performance and function., Change from baseline 5-week, 8-week, and up to 12-week intervention|Cognitive Function, Change in scores or points in Digit-Span test. Two different sets of Forward (from 3 to 9 digits) and Backward (from 2 to 8 digits) Digit-Span recalls test attention and short-term memory. More correct recalls indicate better testing performance and function., Change from baseline 5-week, 8-week, and up to 12-week intervention|Visual Orientation and Executive Function, Change in time to complete Trail-making tests. Less time (in sec) to complete the tests indicates better performance and function., Change from baseline 5-week, 8-week, and after up to 12-week intervention

Neurotoxic Protein, Blood beta-amyloid assessed by enzyme-linked immunosorbent assay. Decreased concentrations indicate a better outcome., before vs after up to 12-week intervention|Neuroprotective Protein, Blood erythropoietin assessed by enzyme-linked immunosorbent assay. Increased concentrations indicate a better outcome., before vs after up to 12-week intervention|Cerebral Vascular Function, Blood volume flow of carotid artery assessed by ultrasonography. Improved volume flow and vascular compliance in carotid arteries indicate a better outcome., before vs after up to 12-week intervention|Brain Morphology, Thickness of cortical gray matter assessed by brain MRI. Increased cerebral cortical gray matter indicates a better outcome., before vs after up to 12-week intervention

University of North Texas Health Science Center

University of Texas Southwestern Medical Center|National Institute on Aging (NIA)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

R01AG076675|R01AG076675

2023-02-27

2025-04-30

2025-04-30

2022-08-10

2023-04-06

University of North Texas Health Science Center, Fort Worth, Texas, 76107, United States

{ "IHT Treatment": [ { "intervention_type": "DEVICE" } ], "Sham-IHT Control": [ { "intervention_type": "OTHER" } ] }

NCT02304887

The Relationship Between the Residual Renal Function and Osteoporosis Treatment

https://clinicaltrials.gov/study/NCT02304887

UNKNOWN

The relationship between osteoporosis drugs and kidney damage is unclear. In this study, we plan to reveal relationship between osteoporosis drugs and kidney damage.

NO

Osteoporosis

DRUG: Bis, SERM Teriparatide, Denosumab

Longitudinal renal function changes by osteoporotic treatment, Up to 120 months

Toshihiko Kono

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

IRB TH No 9-1

2006-01

2018-12

2019-01

2014-12-02

2016-11-25

Tomidahama Hospital, Yokkaichi, Mie, 510-8008, Japan

{ "Denosumab": [ { "intervention_type": "DRUG", "description": "Bis, SERM Teriparatide, Denosumab", "name": "Denosumab", "synonyms": [ "AMG 162", "Denosumab", "Prolia", "Xgeva" ], "medline_plus_id": "a610023", "generic_names": [ "Denosumab" ], "mesh_id": "D050071", "drugbank_id": "DB06643", "wikipedia_url": "https://en.wikipedia.org/wiki/Denosumab" } ] }

NCT01306487

Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery

https://clinicaltrials.gov/study/NCT01306487

COMPLETED

The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

NO

Macular Holes

PROCEDURE: Vitrectomy

Foveal microstructure determined by optical coherence tomography, The integrity of the microstructures of the foveal photoreceptors; the inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined by spectral domain optical coherence tomography., Preoperative and postoperative 1, 3, 6, 9, 12 months

The visual acuity, Preoperative and postoperative best-corrected visual acuity, Preoperative and postoperative 1, 3, 6, 9, 12 months

Kyorin University

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Kyorineye002

2008-03

2009-08

2010-08

2011-03-02

2012-08-02

Kyorin Eye Center, Mitaka, Tokyo, 181-8611, Japan

{ "Vitrectomy": [ { "intervention_type": "PROCEDURE" } ] }

NCT01947387

Retrospective Study Evaluating Outcomes for Integra® Skin Sheet Products in Lower Extremity Complex Wounds

https://clinicaltrials.gov/study/NCT01947387

COMPLETED

This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who received Integra, free flap, local tissue flap, or negative pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index procedure, with index procedure being defined as the application of Integra, free flap, local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for inclusion.

NO

Complex Lower Extremity Soft Tissue Reconstruction

Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy., A dermoinductive agent is a product that is said to promote rapid wound healing., 5 year period

Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy., 5 year period

Time to wound bed preparation for receipt of a split thickness skin graft (STSG) or dermoinductive agent after having received Integra or negative pressure wound therapy, 5 years|Time to complete re-epithelization (as deemed by the surgeon) after Integra application or NPWT, 5 years

Integra LifeSciences Corporation

Georgetown University

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

Integra 11-2011

2013-08

2014-09

2015-02

2013-09-20

2016-12-02

Georgetown University Hospital Wound Healing Center, Washington, District of Columbia, 20007, United States|Northwestern University Feinberg School of Medicine Division of Plastic Surgery, Chicago, Illinois, 60611, United States|Brigham and Womens Hospital, Inc, Boston, Massachusetts, 02115, United States|University of Texas Southwestern Medical Ceter, Dallas, Texas, 75390, United States

{}

NCT04495387

Improving Food Pleasure and Intake of Oncology Patients Receiving Chemotherapy

https://clinicaltrials.gov/study/NCT04495387

UNKNOWN

The global cancer burden is estimated to have risen to 18.1 million new cases in 2018 (WHO), with a trend of ongoing growth. This very frequent illness exerts tremendous physical, emotional and financial strain on individuals, families, communities and health systems. Malnutrition (under- or over-nutrition) is highly prevalent in cancer patients receiving chemotherapy and is an important predictor of morbidity, mortality, treatment response and toxicity. Alterations in taste and smell are frequently reported as side effect of chemotherapy and may contribute strongly to malnutrition and to a worsen quality of life and wellbeing social, emotional, and role functioning. There are evidences that chemotherapy influences food liking and appetite with implications for food behaviours, including food enjoyment, food preference and dietary intake. A linkage between alterations in taste and /or smell and food behaviours has been reported by some studies but not all, suggesting that there is a need for more research using common standardised methodologies and larger sample size to gain a further insight into this topic.

NO

Colon Cancer|Breast Cancer|Chemotherapeutic Toxicity

DRUG: Chemotherapy

change of taste chemotherapy-related alterations, To better understand alteration of taste/smell and food behaviours by the self-report responses, using an adapted version of a questionnaire set up to measure taste changes due to COVID-19, the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)

Emotions elicited by foods, Emotions elicited by foods will be measured on a selection of foods through an EmoSemio questionnaire, a self-report measure of emotion developed based on preliminary interviews, the variables will be measured at four time points: before chemotherapy (T0), after 4 cycles (T1, each cycle is 21 days), at the end of chemotherapy (T2, 6 months from T0) and three months after the conclusion of the therapy (T3, 9 months from T0)

University of Florence

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

ALTERTASTE

2021-07

2022-01

2022-12

2020-07-31

2021-04-27

{ "Chemotherapy": [ { "intervention_type": "DRUG" } ] }

NCT04283487

Brain and Gut Responses to Intragastric Administration of FODMAPs in Healthy Subjects and Patients With Irritable Bowel Syndrome

https://clinicaltrials.gov/study/NCT04283487

FODMAPs

COMPLETED

Low fermentable oligo-, di- and monosaccharides and polyols (FODMAPs) diet is taken as a possible strategy to improve symptoms in IBS patients. However, the gut-brain signalling mechanisms underlying this observation remain poorly understood. In this study, the investigators aim to study the brain mechanisms underlying the effect of intragastric administration of one specific FODMAP (fructans) on gastrointestinal and non- gastrointestinal symptom responses, changes in gut physiology(morphology of the gut, water content and intestinal motility), and to relate the findings to changes in gastrointestinal peptides. Intragastric administration of three different solutions will be given after an overnight fast: one FODMAP solution (fructans), a positive control (glucose) and a negative control (saline). The whole procedure consists of a functional magnetic resonance imaging (fMRI) and abdominal MRI examination, and will take approximately four hours. The participants will undergo the fMRI for one hour for assessing brain activity, during which blood samples will be collected. The abdominal MRI will be performed at 1-hour interval for three hours to assess pre and post stimulated changes in gut physiology, specifically the morphology of the gut water content and pan-intestinal motility. During the whole procedure, questionnaires for assessing the gastrointestinal symptoms and emotional state will be collected. The investigators hypothesise that fructans induce distension and increased sensations of pain, cramps and flatulence in the IBS group more than the HC. Furthermore, this will be associated with increased activation of pain-responsive brain regions in IBS compared to HC, which will be mediated by differential changes in gut peptide levels (↓ in orexigenic and ↑ in anorexigenic hormones).

NO

Irritable Bowel Syndrome

DIETARY_SUPPLEMENT: Fructans|DIETARY_SUPPLEMENT: Glucose|DIETARY_SUPPLEMENT: Saline

Change in brain activation patterns measured by fMRI, change in blood oxygenation level dependent (BOLD) signal by fMRI, -10 min to 50 min

Change in gastrointestinal symptom scores measured by VAS, bloating, nausea, cramps, flatulence and abdominal pain, -30 min to 180 min|Change in state emotion score measured by validated questionnaire, emotion score measured by POMS, -30 min to 180 min|Change in state emotion score measured by validated questionnaire, emotion score measured by PANAS, -30 min to 180 min|Change in plasma levels of gut peptides, Plasma levels of ghrelin, -20 min to 60 min|Change in plasma levels of gut peptides, Plasma levels of CCK, -20 min to 60 min|Change in plasma levels of gut peptides, Plasma levels of GLP-1, -20 min to 60 min|Change in plasma levels of gut peptides, Plasma levels of motilin, -20 min to 60 min|Change in plasma levels of gut peptides, Plasma levels of PYY, -20 min to 60 min|Change in plasma levels of gut peptides, Plasma levels of insulin, -20 min to 60 min|Change in plasma levels of gut peptides, Plasma levels of glucose, -20 min to 60 min|Change in gut physiology measured by abdominal MRI, Gastric emptying and accommodation, antral and small bowel motility, water and gas content measured by abdominal MRI, -20 min to 180 min

Universitaire Ziekenhuizen KU Leuven

FEMALE

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: OTHER

FODMAP2

2018-02-22

2019-08-10

2019-08-10

2020-02-25

2021-05-28

KU Leuven, Leuven, 3000, Belgium

{ "Fructans": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Glucose": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Saline": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT05149287

PROPER Trial of Pain and Inflammation After Knee Arthroscopy

https://clinicaltrials.gov/study/NCT05149287

PROPER

TERMINATED

The purpose of this study is to determine if ceftriaxone administered postoperatively via intravenous injection reduces postoperative visual analog scale (VAS) pain scores and narcotic consumption in patients undergoing knee arthroscopy for a cartilage or meniscal injury.

YES

Meniscus Tear|Meniscus Lesion|Cartilage Injury

DRUG: Ceftriaxone|OTHER: Placebo

Change in Visual Analog Scale (VAS) Pain Score, The Visual analog scale scores range from 0 to 10 with greater scores indicative of greater pain., Pre-operative, 2 months post-operative|Change in RU SATED Score, The Regularity, Sleep Quality, Alertness, Timing, Efficiency, Duration scale for sleep (RU SATED) ranges from 0 to 30, with higher scores indicating better sleep health., Pre-operative, 2 months post-operative|Post-operative Narcotic Use, Post-operative narcotic use will be monitored with self-reported medication consumption at the first post-operative visit, which will take place 5-12 days post-operative. The milligrams of morphine equivalent (MME) will be calculated based on patient responses with greater MME indicative of increased postoperative use of narcotic pain medications., 5-12 days post-operative

Austin V Stone

ALL

ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

63476

2021-12-28

2022-04-29

2022-04-29

2021-12-08

2023-09-05

2023-09-05

University of Kentucky, Lexington, Kentucky, 40506, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT05149287/Prot_SAP_000.pdf

{ "Ceftriaxone": [ { "intervention_type": "DRUG", "description": "Ceftriaxone", "name": "Ceftriaxone", "synonyms": [ "Ceftriaxone, Disodium Salt, Hemiheptahydrate", "Longacef", "Ceftriaxona", "Ro 13 9904", "Anhydrous Ceftriaxone Sodium", "Cefatriaxone", "Ro139904", "Rocephin", "Ceftriaxone Irex", "Ro13 9904", "Ceftrex", "Ceftriaxone, Disodium Salt", "Ceftriaxone", "Terbac", "Ro-13-9904", "Ceftriaxone Sodium, Anhydrous", "Rocephine", "Ceftriaxon Curamed", "Ceftriaxon", "Lendacin", "Tacex", "Ro13-9904", "Cefaxona", "Ceftriaxon Hexal", "Longaceph", "Ceftriaxona Andreu", "Ro 139904", "Ceftriaxona LDP Torlan", "Rocefalin", "Ro 13-9904", "Rocefin", "Benaxona", "Ceftriaxonum", "Ceftriaxone Sodium" ], "medline_plus_id": "a685032", "generic_names": [ "Ceftriaxone" ], "mesh_id": "D000097911", "drugbank_id": "DB01212" } ], "Placebo": [ { "intervention_type": "OTHER" } ] }

NCT05927987

Feasibility and Acceptability of Problem Management Plus (PM+) for Prisoners in the Netherlands - a Pilot RCT

https://clinicaltrials.gov/study/NCT05927987

PROSPER

NOT_YET_RECRUITING

The goal of this pilot randomised controlled trial is to evaluate the feasibility and acceptability of the - specifically to the prison context adapted - World Health Organizations Problem Management Plus (PM+) intervention for individuals detained in Dutch remand prisons. The main question[s] it aims to answer are: * To what extent is the contextually adapted PM+ intervention feasible and acceptable for individuals detained in Dutch remand prisons? * To what extent are there preliminary indications of pre to post-effects of the PM+ intervention on, for example, anxiety and depression symptoms? Researchers will compare two groups to answer these questions. Participants will either receive the PM+ intervention and Care-as-Usual or only Care-as-Usual.

NO

Anxiety Disorders|Psychological Distress|Depressive Disorder

BEHAVIORAL: Problem Management Plus (PM+)

Feasibility and acceptability of PM+, Factors relevant to the study of this outcome are: 1. PM+ fidelity; 2. The perceptions about PM+ from RCT participants, helpers, supervisors, trainers, professionals, and family members & friends of RCT participants; 3. Indicators of intervention delivery, such as implementation process, adaptation, and dose. 4. Retention rate PM+ sessions; and 5. Recruitment and the consent rates., Outcomes are gathered throughout the study: during (factor 1) and after the trial finished (factors 2, 3, 4 and 5). We estimate inclusion will take about 9 months. Thus these factors will likely be gathered over a time frame of about one year.

Preliminary indications of pre to post-effects on symptoms of depression and anxiety, Measured by Patient Health Questionnaire - 9 (PHQ9, depression) and Generalized Anxiety Disorder-7 (GAD-7, anxiety). A higher score on the PHQ9 (range = 1 - 27) means a greater severity of depressive symptoms. A higher score on the GAD-7 (range = 0 - 21) means a greater severity of anxiety symptoms., Measured at baseline (week 0), week 8 and 13 weeks after baseline.|Preliminary indications of pre to post-effects on self-identified problems, Measured by Psychological Outcome Profiles (PSYCHLOPS, self-identified problems). A higher score on the PSYCHLOPS (range = 0 - 20) means a greater severity of self-identified problems., Measured at baseline (week 0), week 8 and 13 weeks after baseline.|Preliminary indications of pre to post-effects on quality of life, Measured by World Health Organization Quality of Life Scale - brief (WHOQOL-BREF, quality of life). The score range differs per domain, but a higher score on every domain means a higher perceived quality of life. Domain I: 7 - 35. Domain II: 6 - 30. Domain III: 3 - 15. Domain IV: 8 - 40. Facet Overall Quality of Life and Health 2-10., Measured at baseline (week 0), week 8 and 13 weeks after baseline.|Preliminary indications of pre to post-effects on trauma, Measured by Post Traumatic Stress Disorder Checklist DSM5 (PCL-5, PTSD symptoms). A higher score on the PCL-5 (range = 0 - 80) means a greater severity of PTSD symptoms., Measured at baseline (week 0), week 8 and 13 weeks after baseline.|Preliminary indications of pre to post-effects on suicidal vulnerability, Measured by Suicide Concerns for Offenders in Prison Environment - 2 (SCOPE-2, suicidal vulnerability). A higher score on the SCOPE-2 (range = 19 - 76) means a greater vulnerability for suicide and non-fatal self-harm behaviour., Measured at baseline (week 0), week 8 and 13 weeks after baseline.

VU University of Amsterdam

Netherlands Institute for the Study of Crime and Law Enforcement (NSCR)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

PROSPER

2024-04-01

2024-09-30

2024-12-31

2023-07-03

2024-02-08

Vrije Universiteit Amsterdam, Amsterdam, Netherlands

{ "Problem Management Plus (PM+)": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04440787

Prevention of Endotracheal Tube Migration by Cuff Palpation During Robotic Surgical Procedure

https://clinicaltrials.gov/study/NCT04440787

UNKNOWN

After intubation, the endotracheal tube was finally fixed after palpating endotracheal cuff at three sites (just below the cricoid cartilage, at suprasternal level and just below suprasternal notch). Fibre optic bronchoscopy will be done to find distance between tip of endotracheal tube and carina. This distance will be measured repeatedly, after pneumoperitoneum, after trendelenburg position and after making the patient supine at the end of surgery. Change in the distance will be noted.

NO

Robotic Surgical Procedures

PROCEDURE: Three point cuff palpation technique

Measure the distance between tip of endotracheal tube and Carina by fiber-optic bronchoscopy and measuring scale at various phases of robotic surgical procedure., proper endotracheal tube placement is labelled when the distance between the tip of tube and Carina is more than 2.5 cm, after placement the tube by three point cuff palpation technique, its position will be assessed at respective time points., Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.pneumoperitoneum.

find the effect of cricod cartilage and supra-sternal distance on endotracheal tube tip to Carina distance., cricoid cartilage to suprasternal distance changes with the position of neck, so it could affect the distance between the endotracheal tube tip and carina as the position of patient changes during various robotic surgical steps., Throughout robotic surgical procedure, immediately after intubation, 5 minute after pneumoperitoneum, 10 minutes after trendelenburg position and after dedocking and making patient supine.

Rajiv Gandhi Cancer Institute & Research Center, India

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RES/SCM/30/2018/81

2018-12-01

2021-01-19

2021-03-31

2020-06-22

2020-06-22

Rajiv Gandhi Cancer Institute & Research center, Rohini, New Delhi, 110085, India

{ "Three point cuff palpation technique": [ { "intervention_type": "PROCEDURE" } ] }

NCT01418287

Characterization of Influenza-like Illness in Mexico

https://clinicaltrials.gov/study/NCT01418287

COMPLETED

A study to characterize children and adults with influenza like symptoms and to determine risk factors for severe disease and death among those with H1N1.

NO

Influenza-like Illness

Characterize individuals who develop influenza-like illness, influenza A, and/or H1N1 or other viruses, Characterize demographics, co-morbid conditions, prior influenza vaccination, the use of antivirals, and clinical course and treatment, 5 years

Death, For all participants, to estimate the percentage who die, 5 years|Hospitalization, For all participants, to estimate the percentages who require hospitalization due to severe influenza, 5 years|Risk factors, For all participants, to determine risk factors for severe disease, 5 years|Repository of oropharyngeal and nasal samples, Establish a repository of oropharyngeal and nasal samples to determine a precise diagnosis, to molecularly characterize the virus, 5 years|Repository of serum and PBMC, Establish a repository of serum and PBMC to study biomarkers that predispose and correlate with severe influenza, 5 years

Mexican Emerging Infectious Diseases Clinical Research Network

National Institute of Allergy and Infectious Diseases (NIAID)|Secretaria de Salud, Mexico|Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran|Instituto Nacional de Enfermedades Respiratorias|National Institute of Pediatrics, Mexico|Hospital General Dr. Manuel Gea González|Hospital Infantil de Mexico Federico Gomez|Hospital Central Dr. Ignacio Morones Prieto

ALL

CHILD, ADULT, OLDER_ADULT

NETWORK

OBSERVATIONAL

Observational Model: |Time Perspective: p

ILI002|HHSN272200900003I

2010-04

2014-05

2014-05

2011-08-17

2014-09-11

Instituto Nacional de Pediatría (INP), México City, México, CP 04530, Mexico|Hospital Infantil de México Federico Gómez (HIM), México City, México, CP 06720, Mexico|Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ), México City, México, CP 14000, Mexico|Hospital General y de Alta Especialidad Dr. Manuel Gea González, México City, México, CP 14080, Mexico|Instituto Nacional de Enfermedades Respiratorias (INER), México City, México, CP 14080, Mexico|San Luis Potosí (SLP):Hospital Central Dr. Ignacio Morones Prieto/Universidad Autónoma de San Luis Potosí, San Luis Potosí, CP 78240, Mexico

{}

NCT04773587

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

https://clinicaltrials.gov/study/NCT04773587

INTEGUMENT-I

COMPLETED

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

NO

Atopic Dermatitis Eczema

DRUG: ARQ-151 Active|DRUG: ARQ-151 Vehicle

IGA Success, defined as a vIGA-AD score of clear or almost clear PLUS a 2-grade improvement from Baseline at Week 4., The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear)., Week 4

Subjects with a vIGA-AD score of Moderate at randomization, vIGA-AD Success at Week 4, IGA Success, defined as a vIGA-AD score of clear or almost clear PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear)., Week 4|In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 4, WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from 0 to 10 ( no itch to worst imaginable itch )., Week 4|In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 2, WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from 0 to 10 ( no itch to worst imaginable itch )., Week 2|In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 1, WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from 0 to 10 ( no itch to worst imaginable itch )., Week 1|Achievement of at least a 75% (percent) reduction in the Eczema Area and Severity Index (EASI-75) at Week 4, EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas., Week 4|vIGA-AD of clear or almost clear at Week 4, The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear)., Week 4|vIGA-AD success at Week 2, The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear)., Week 2|vIGA-AD success at Week 1, The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear)., Week 1|vIGA-AD of clear or almost clear at Week 2, The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear)., Week 2|vIGA-AD of clear or almost clear at Week 1, The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear)., Week 1

Arcutis Biotherapeutics, Inc.

ALL

CHILD, ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

ARQ-151-311

2021-01-27

2022-08-30

2022-08-30

2021-02-26

2023-07-27

Arcutis Clinical Site 57, Montgomery, Alabama, 36117, United States|Arcutis Clinical Site 34, Scottsdale, Arizona, 85255, United States|Arcutis Clinical Site 58, Little Rock, Arkansas, 72212, United States|Arcutis Clinical Site 40, Beverly Hills, California, 90212, United States|Arcutis Clinical Site 06, Encinitas, California, 92024, United States|Arcutis Clinical Site 52, Los Angeles, California, 90056, United States|Arcutis Clinical Site 05, San Diego, California, 92123, United States|Arcutis Clinical Site 08, San Francisco, California, 94132, United States|Arcutis Clinical Site 62, Thousand Oaks, California, 91320, United States|Arcutis Clinical Site 30, Coral Gables, Florida, 33134, United States|Arcutis Clinical Site 04, Jacksonville, Florida, 32256, United States|Arcutis Clinical Site 15, Largo, Florida, 33770, United States|Arcutis Clinical Site 39, Miami Lakes, Florida, 33014, United States|Arcutis Clinical Site 38, North Miami Beach, Florida, 33162, United States|Arcutis Clinical Site 01, Tampa, Florida, 33613, United States|Arcutis Clinical Site 61, Wellington, Florida, 33449, United States|Arcutis Clinical Site 26, Sandy Springs, Georgia, 30328, United States|Arcutis Clinical Site 13, Rolling Meadows, Illinois, 33770, United States|Arcutis Clinical Site 48, Clarksville, Indiana, 47129, United States|Arcutis Clinical Site 02, Indianapolis, Indiana, 46250, United States|Arcutis Clinical Site 03, Louisville, Kentucky, 40217, United States|Arcutis Clinical Site 36, Rockville, Maryland, 20850, United States|Arcutis Clinical Site 55, Auburn Hills, Michigan, 48326, United States|Arcutis Clinical Site 54, Bay City, Michigan, 48706, United States|Arcutis Clinical Site 46, Clarkston, Michigan, 48346, United States|Arcutis Clinical Site 37, Detroit, Michigan, 48202, United States|Arcutis Clinical Site 10, New Brighton, Minnesota, 55112, United States|Arcutis Clinical Site 33, Reno, Nevada, 89509, United States|Arcutis Clinical Site 42, East Windsor, New Jersey, 08520, United States|Arcutis Clinical Site 17, Gresham, Oregon, 97030, United States|Arcutis Clinical Site 16, Portland, Oregon, 97223, United States|Arcutis Clinical Site 14, Portland, Oregon, 97239, United States|Arcutis Clinical Site 35, Newtown Square, Pennsylvania, 19073, United States|Arcutis Clinical Site 101, Johnston, Rhode Island, 02919, United States|Arcutis Clinical Site 31, Murfreesboro, Tennessee, 37130, United States|Arcutis Clinical Site 19, Arlington, Texas, 76011, United States|Arcutis Clinical Site 43, Bellaire, Texas, 77401, United States|Arcutis Clinical Site 27, Houston, Texas, 77030, United States|Arcutis Clinical Site 20, Houston, Texas, 77056, United States|Arcutis Clinical Site 28, San Antonio, Texas, 78218, United States|Arcutis Clinical Site 21, South Jordan, Utah, 84095, United States|Arcutis Clinical Site 12, Spokane, Washington, 99202, United States|Arcutis Clinical Site 41, Calgary, Alberta, T2J 7E1, Canada|Arcutis Clinical Site 29, Fredericton, New Brunswick, E3B 1G9, Canada|Arcutis Clinical Site 11, Markham, Ontario, L3P 1X3, Canada|Clinical Site 25, Mississauga, Ontario, L5H 1G9, Canada|Arcutis Clinical Site 32, Peterborough, Ontario, K9J 5K2, Canada|Arcutis Clinical Site 09, Windsor, Ontario, N8W 1E6, Canada|Arcutis Clinical Site 24, Montréal, Quebec, H2X 2V1, Canada

{ "ARQ-151 Active": [ { "intervention_type": "DRUG" } ], "ARQ-151 Vehicle": [ { "intervention_type": "DRUG" } ] }

NCT01736787

Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

https://clinicaltrials.gov/study/NCT01736787

COMPLETED

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT), and monitored their blood pressure.

NO

Immunity

DIETARY_SUPPLEMENT: Cauliflower Mushroom extract|DIETARY_SUPPLEMENT: Placebo

Changes in Cytotoxicity, Cytotoxicity was measured in study visit 1(0 week) and visit 3(12 week). cytotoxicity was measured by NK cell activity. Cytotoxicity (%) = (experimental release - spontaneous release) / (maximum release - spontaneous release) x 100, 12 weeks|Changes in Cytokine (IL-4, IL-10, IFN- γ, TNF-α), Cytokine (IL-4, IL-10, IFN- γ, TNF-α) was measured in study visit 1(0 week) and visit 3(12 week)., 12 weeks

Changes in CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT), CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT) was measured in study visit 1(0 week) and visit 3(12 week)., 12 weeks

Chonbuk National University Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: PREVENTION

HANABIO-PI-CM

2012-09-17

2013-01-18

2013-01-18

2012-11-29

2019-09-03

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital, Jeonju, Jeollabuk-do, 560-822, Korea, Republic of

{ "Cauliflower Mushroom extract": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Placebo": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT00656487

Clinical and Neurobiological Effects of Cannabis Dependence in Young Adults

https://clinicaltrials.gov/study/NCT00656487

SCCAN

COMPLETED

The purpose of this study is to find out more about cognitive functioning in people who are cannabis dependent, relative to people who do not use cannabis, and how their brains process information after one month of not using cannabis. An additional goal is to characterize the severity of cannabis dependence using precipitated and naturalistic withdrawal with a double blind, placebo controlled, single administration of rimonabant. Research assessments occur bi-weekly throughout this 28 day study.

YES

Cannabis Dependence|Cannabis Withdrawal

DRUG: rimonabant|DRUG: placebo

Withdrawal Symptom Severity on the Marijuana Withdrawal Checklist (MWC) at 28 Days Following Single Dose Administration of Rimonabant or Placebo, or Commencement of Monitoring, During the Double-Blind Period, The MWC is a 28-item instrument that is used to assess the severity of frequently reported cannabis withdrawal symptoms. Each item on the measure is recorded as a severity rating between 0-3 where a zero indicates not present and a three indicates severe. The severity rating of each item was summed to obtain a single marijuana withdrawal severity score ranging between 0- 84. A lower score indicates less severe withdrawal., Day 28|Plasma Norepinephrine, Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period., Day 28|Plasma Cortisol, Blood samples were obtained and plasma concentrations were determined using validated enzyme-linked immunosorbent assay (ELISA) techniques at 28 days following single dose administration of rimonabant or placebo, or commencement of monitoring, during the double-blind period., Day 28|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Strategy Score at Day 28, The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Strategy Score is an estimate of use of the most efficient strategy to complete the task. Scores range from 8-56; higher scores equate to poor use of the most efficient strategy. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement., Day 0 and Day 28|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Total Errors at Day 28, The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Total Errors are a measure of performance and are unbounded. Change = (Day 28 Score - Day 0 Score). A more negative result indicates greater improvement., Day 0 and Day 28|Change From Day 0 in Performance on the Cambridge Neuropsychological Test Automated Batteries Spatial Working Memory (CANTAB SWM) Mean Time To First Response at Day 28, The CANTAB SWM task is a validated computer-based testing instrument assessing the memory component of executive function. Mean Time To First Response is a measure of latency and is unbounded. Change = (Day 28 Time - Day 0 Time). A more negative result indicates greater improvement., Day 0 and Day 28

The Scripps Research Institute

National Institute on Drug Abuse (NIDA)

ALL

ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: DIAGNOSTIC

DA024194|P20DA024194

2008-04-30

2010-12-28

2011-01-06

2008-04-11

2017-05-15

2017-06-19

The Scripps Research Institute, La Jolla, California, 92037, United States

{ "Rimonabant": [ { "intervention_type": "DRUG", "description": "rimonabant", "name": "Rimonabant", "synonyms": [ "SR141716", "Rimonabant", "SR 141716", "N-(Piperidin-1-yl)-5-(4-chlorophenyl)-1-(2,4-dichlorophenyl)-4-methyl-1H-pyrazole-3-carboxamide hydrochloride", "Acomplia", "SR141716A", "SR 141716A", "SR-141716A", "Rimonabant Hydrochloride", "Zimulti" ], "mesh_id": "D063387", "generic_names": [ "Rimonabant" ], "drugbank_id": "DB06155" } ], "placebo": [ { "intervention_type": "DRUG" } ] }

NCT02605187

Patient-Driven Analgesic Protocol Selection for Post-Cesarean Pain Management

https://clinicaltrials.gov/study/NCT02605187

COMPLETED

The ability to predict pain and then apply modified treatment protocols has been limited. Current practice is for physicians to select standard post-operative pain treatment protocols without patient consultation. This study hopes to determine if patients involvement in analgesic drug/dosage selection can optimize pain relief while minimizing related side effects. This could result in a more patient-centered care model and individualized perioperative analgesic treatment protocols based on patients preferences, needs and expectations.

YES

Postoperative Pain

OTHER: No choice given|OTHER: Choice given|DRUG: Ibuprofen|DRUG: Acetaminophen|DRUG: Gabapentin|DRUG: Morphine (low)|DRUG: Morphine (med)|DRUG: Morphine (high)

Opioid Consumption in the 0-48 Hour Study Periods., Opioid consumption was measured in milligram morphine equivalents in the 0-24 and 24-48 hour study periods., 0-24 and 24-48 hour postoperative periods|Pain Scores, Pain scores at rest and at movement post-cesarean delivery. Score was rated on a scale from 0 to 10, where 0=no pain and 10=worst imaginable pain., 3, 6, 12, 24, 36 and 48 hours after delivery

Count of Participants Who Need Opioid Use, Count of participants who need opioid use through 48 hours after delivery., 0-24 and 24-48 hours after delivery|Count of Participants With Presence of Pruritus, Count of participants with pruritus through 48 hours after delivery., 0-24 and 24-48 hours after delivery|Pruritus Score at 24 and 48 After Delivery, Score was rated on a scale from 0 to 10, where 0=no itching and 10=most itching., 24 and 48 hours following delivery|Count of Participants Who Need Medical Treatment of Pruritus, Count of participants who need medical treatment of pruritus during first 48 hours after delivery., 0-24 and 24-48 hours after delivery|Counts of Participants With Presence of Nausea, Count of participants with nausea through 48 hours after delivery., 0-48 hours after delivery|Nausea Score Score at 24 and 48 After Delivery, Score was rated on a scale from 0 to 10, where 0=no nausea and 10=most nausea., 0-24 and 24-48 hours after delivery|Counts of Participants Who Need Medical Treatment for Nausea, Counts of participants who need medical treatment of nausea through 48 hours after delivery., 0-24 and 24-48 hours after delivery|Average Number of Vomiting Episodes After Delivery, 0-24 and 24-48 hours after delivery|Time to Discharge, Minutes from delivery until discharge., Delivery through discharge (average 4 days)|Patient Overall Satisfaction With Postoperative Analgesia, Score was rated on a scale from 0 to 100, where 0=completely unsatisfied and 100=completely satisfied., 24 and 48 hours after delivery

Stanford University

FEMALE

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

34740

2015-11

2017-05-22

2017-05-22

2015-11-16

2018-06-11

2018-10-16

Lucille Packard Childrens Hospital, Palo Alto, California, 94305, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT02605187/Prot_SAP_000.pdf

{ "No choice given": [ { "intervention_type": "OTHER" } ], "Choice given": [ { "intervention_type": "OTHER" } ], "Ibuprofen": [ { "intervention_type": "DRUG", "description": "Ibuprofen", "name": "Ibuprofen", "synonyms": [ "Ibuleve", "Ibuprofen, (+-)-Isomer", "Brufen", "Ibuprophen", "Ibuprofen-Zinc", "alpha-Methyl-4-(2-methylpropyl)benzeneacetic Acid", "Ultraprin", "\u03b1-(p-isobutylphenyl)propionic acid", "OtherBrufen", "\u03b1-(4-isobutylphenyl)propionic acid", "Rufen", "Ibugel", "Ibumetin", "Ibuprofen, Copper (2+) Salt", "Nurofen", "Ibuprofen, Sodium Salt", "Ibuprofenum", "Benzeneacetic Acid, alpha-methyl-4-(2-methylpropyl)- trimethylsilyl ester", "Ibuprofeno", "Ibuprofen, Magnesium Salt", "Motrin", "Addaprin", "Ibuprofen, (S)-Isomer", "(4-isobutylphenyl)-\u03b1-methylacetic acid", "(\u00b1)-p-isobutylhydratropic acid", "Cedaprin", "Ibuprofen, Aluminum Salt", "(RS)-ibuprofen", "Calprofen", "Nurofen for Children", "Profen IB", "Fenbid", "(\u00b1)-2-(p-isobutylphenyl)propionic acid", "Ibuprofen, Potassium Salt", "Ibuprofen, (R)-Isomer", "Ibuprofen", "(\u00b1)-ibuprofen", "Advil", "Salprofen", "Ibuprofene", "Nuprin", "Midol", "Ibuprofen, Calcium Salt", "Trauma Dolgit Gel", "2-(4-isobutylphenyl)propanoic acid", "Ibuprofen, Zinc Salt", "4-isobutylhydratropic acid", "Trauma-Dolgit Gel", "(\u00b1)-\u03b1-methyl-4-(2-methylpropyl)benzeneacetic acid", "Ibuprofen Zinc" ], "medline_plus_id": "a682159", "generic_names": [ "Ibuprofen" ], "nhs_url": "https://www.nhs.uk/medicines/ibuprofen-for-children", "mesh_id": "D018712", "drugbank_id": "DB01050" } ], "Acetaminophen": [ { "intervention_type": "DRUG", "description": "Acetaminophen", "name": "Acetaminophen", "synonyms": [ "Parac\u00e9tamol", "4-(Acetylamino)phenol", "p-Acetamidophenol", "Acetominophen", "Anacin 3", "Paracetamolum", "p-hydroxyphenolacetamide", "Actamin", "Hydroxyacetanilide", "N-acetyl-p-aminophenol", "Datril", "4'-hydroxyacetanilide", "p-acetaminophenol", "Acetaco", "p-acetamidophenol", "Neopap Supprettes Rectal Suppository", "Acetaminophen", "N-(4-Hydroxyphenyl)acetanilide", "APAP", "Ac\u00e9taminoph\u00e8ne", "Algotropyl", "Ofirmev", "p-hydroxyacetanilide", "N-Acetyl-p-aminophenol", "Acetaminof\u00e9n", "Acamol", "p-Acetylaminophenol", "Panadol", "Paracetamol", "Acenol", "Tylenol", "Acetamidophenol", "p-hydroxy-acetanilid", "p-Hydroxyacetanilide", "4-acetamidophenol", "Anacin-3", "Anacin3", "Acephen Rectal Suppository", "Acephen", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Acetaminophen and Codeine", "Capital", "Phenaphen", "Empracet", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Acetaminophen and Codeine", "Capital", "Phenaphen", "Empracet", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol", "Disprol", "- OtherDisprol", "Calpol", "Hedex", "Medinol", "Panadol", "Paracetamol", "Tylenol" ], "medline_plus_id": "a621016", "generic_names": [ "Acetaminophen", "Acetaminophen and Codeine", "Acetaminophen and Codeine" ], "mesh_id": "D058633", "drugbank_id": "DB00316", "nhs_url": "https://www.nhs.uk/medicines/paracetamol-for-children" } ], "Gabapentin": [ { "intervention_type": "DRUG", "description": "Gabapentin", "name": "Gabapentin", "synonyms": [ "Gabapentina", "Gabapentin", "Gabapentinum", "Gabapentino", "Gabapentine", "Gralise", "Neurontin", "1-(Aminomethyl)cyclohexaneacetic acid" ], "medline_plus_id": "a694007", "generic_names": [ "Gabapentin" ], "nhs_url": "https://www.nhs.uk/medicines/gabapentin", "drugbank_id": "DB00996", "wikipedia_url": "https://en.wikipedia.org/wiki/Gabapentin" } ], "Morphine": [ { "intervention_type": "DRUG", "description": "Morphine (low)", "name": "Morphine", "synonyms": [ "Anhydrous morphine", "Morphium", "MXL", "Morphine Chloride", "SDZ 202250", "Arymo", "Morphin", "(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "Contin, MS", "Morfina", "SDZ 202 250", "(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol", "(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol", "(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Sevredol", "Oramorph", "SDZ202-250", "Morphine Sulfate (2:1), Anhydrous", "Chloride, Morphine", "Morphine", "Roxanol-T", "Morphgesic", "Oramorph SR", "Morphine Sulfate", "Morphia", "Astramorph", "Zomorph", "(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Infumorph", "MS Contin", "Sulfate, Morphine", "Morphine Sulfate (2:1), Pentahydrate", "Morphinum", "RMS", "MST", "Kadian", "Duramorph", "SDZ 202-250", "SDZ202250", "SDZ202 250", "(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "(\u2212)-morphine" ], "medline_plus_id": "a606006", "generic_names": [ "Morphine" ], "nhs_url": "https://www.nhs.uk/medicines/morphine", "mesh_id": "D009294", "drugbank_id": "DB00295" }, { "intervention_type": "DRUG", "description": "Morphine (med)", "name": "Morphine", "synonyms": [ "Anhydrous morphine", "Morphium", "MXL", "Morphine Chloride", "SDZ 202250", "Arymo", "Morphin", "(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "Contin, MS", "Morfina", "SDZ 202 250", "(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol", "(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol", "(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Sevredol", "Oramorph", "SDZ202-250", "Morphine Sulfate (2:1), Anhydrous", "Chloride, Morphine", "Morphine", "Roxanol-T", "Morphgesic", "Oramorph SR", "Morphine Sulfate", "Morphia", "Astramorph", "Zomorph", "(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Infumorph", "MS Contin", "Sulfate, Morphine", "Morphine Sulfate (2:1), Pentahydrate", "Morphinum", "RMS", "MST", "Kadian", "Duramorph", "SDZ 202-250", "SDZ202250", "SDZ202 250", "(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "(\u2212)-morphine" ], "medline_plus_id": "a606006", "generic_names": [ "Morphine" ], "nhs_url": "https://www.nhs.uk/medicines/morphine", "mesh_id": "D009294", "drugbank_id": "DB00295" }, { "intervention_type": "DRUG", "description": "Morphine (high)", "name": "Morphine", "synonyms": [ "Anhydrous morphine", "Morphium", "MXL", "Morphine Chloride", "SDZ 202250", "Arymo", "Morphin", "(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "Contin, MS", "Morfina", "SDZ 202 250", "(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol", "(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol", "(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Sevredol", "Oramorph", "SDZ202-250", "Morphine Sulfate (2:1), Anhydrous", "Chloride, Morphine", "Morphine", "Roxanol-T", "Morphgesic", "Oramorph SR", "Morphine Sulfate", "Morphia", "Astramorph", "Zomorph", "(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Infumorph", "MS Contin", "Sulfate, Morphine", "Morphine Sulfate (2:1), Pentahydrate", "Morphinum", "RMS", "MST", "Kadian", "Duramorph", "SDZ 202-250", "SDZ202250", "SDZ202 250", "(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "(\u2212)-morphine" ], "medline_plus_id": "a606006", "generic_names": [ "Morphine" ], "nhs_url": "https://www.nhs.uk/medicines/morphine", "mesh_id": "D009294", "drugbank_id": "DB00295" } ] }

NCT04001387

Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning

https://clinicaltrials.gov/study/NCT04001387

UNKNOWN

Confirming the L4-L5 or L3-L4 vertebrae level with ultrasound in real time for adults who scheduled elective surgery under spinal anesthesia, and introduce the spinal needle into the subarachnoid space. The ultrasound probe continues to track needle tips in real time by sliding/tilting with short axis view. Check that the spinal needle reaches subarachnoid space, and that CSF is released through the needle hub, and administer the drug. In this process, it is recorded by observing the success of the procedure, the time taken for each step, the number of needle position changes, NRS pain score of the subject, satisfaction with anesthesia, and its side effects.

NO

Regional Anesthesia Morbidity

PROCEDURE: Real-time ultrasound guided spinal anesthesia

Successful perfomance of spinal anesthesia, Rate of successful performance of real-time ultrasound guided spinal needle insertion using dynamic needle tip positioning, Assessed at time of spinal anesthetic injection (baseline)

Seoul National University Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

20-2019-32

2019-10-27

2020-05-26

2020-06-26

2019-06-28

2019-09-23

Seoul National University Hospital, Seoul, 03080, Korea, Republic of

{ "Real-time ultrasound guided spinal anesthesia": [ { "intervention_type": "PROCEDURE" } ] }

NCT01354587

Evaluation of Efficacy and Tolerability of Hizentra®

https://clinicaltrials.gov/study/NCT01354587

UNKNOWN

The purpose of this study is to measure the changes in the Treatment Satisfaction Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.

NO

Primary Immunodeficiency Disorders

DRUG: Hizentra

To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®., Subjects complete the TSQM at each study visit, 32 weeks

To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®., Study subjects complete a weekly infusion diary that is collected at each study visit., 32 weeks|To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®., IgG levels are obtained at each visit., 32 weeks

University of South Florida

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

Hizentra

2010-10

2012-08

2012-08

2011-05-17

2012-07-17

University of South Florida, St. Petersburg, Florida, 33701, United States

{ "Immunoglobulin therapy": [ { "intervention_type": "DRUG", "description": "Hizentra", "name": "Immunoglobulin therapy", "synonyms": [ "Gammagard", "Immunoglobulin therapy", "Hizentra", "Flebogamma" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Immunoglobulin%20therapy", "generic_names": [] } ] }

NCT03060187

Proposal and Clinical Evaluation of a Comprehensive Airway Exam Score

https://clinicaltrials.gov/study/NCT03060187

COMPLETED

The purpose of this observational study is to evaluate the usefulness of Kansas University airway exam score ( KU score ) in predicting difficulty of placement of a breathing tube into the windpipe.

NO

Intubation

OTHER: KU Score

Correlation between KU score and intubation difficulty scale (IDS) measure, The measure is assessed during the time period between the start of preoperative examination on the day of surgery and completion of a standard tracheal intubation in the operating room. Correlation measured using the Spearman correlation coefficient., Time between preoperative exam to after intubation, up to 3 hours

University of Kansas Medical Center

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

12093

2010-02

2011-01

2011-01

2017-02-23

2017-02-23

University of Kansas Medical Center, Kansas City, Kansas, 66160, United States

{ "KU Score": [ { "intervention_type": "OTHER" } ] }

NCT03391687

Incidence of Pancreatic Fistula After Radical Gastrectomy

https://clinicaltrials.gov/study/NCT03391687

UNKNOWN

This study is designed to investigate the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients.

NO

Gastric Cancer|Pancreatic Fistula|Complication

DIAGNOSTIC_TEST: Amylase Test

Incidence of Pancreatic Fistula, the incidence of pancreatic fistula after radical gastrectomy in gastric cancer patients, in 30 days following gastrectomy

The Classification of Pancreatic Fistula, the percentage of different grades of pancreatic fistula, including Grade BL, Grade B and Grade C, in 30 days following gastrectomy|The mortality of Grade B and C Pancreatic Fistula, the percentage of patients died of Grade B or C pancreatic fistula, in 30 days following gastrectomy

Shanghai Zhongshan Hospital

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

ZSGC-003

2017-12-01

2018-11-30

2018-11-30

2018-01-05

2018-01-05

Beijing Cancer Hospital, Beijing, Beijing, China|Beijing Chao-Yang Hospital, Beijing, Beijing, China|South West Hospital, Chongqing, Chongqing, China|South West Hospital, Chongqing, Chongqing, China|Fujian Cancer Hospital, Fuzhou, Fujian, China|Fujian Medical University Union Hospital, Fuzhou, Fujian, China|Guangdong General Hospital, Guangzhou, Guangdong, China|The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China|Henan Cancer Hospital, Zhengzhou, Henan, China|Jiangsu Province Hospital, Nanjing, Jiangsu, China|The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China|The Second Hospital of Jilin University, Changchun, Jilin, China|Affiliated Hospital of Qinghai University, Xining, Qinghai, China|Weifang Peoples Hospital, Weifang, Shandong, China|ZhongShan hospital Fudan university, Shanghai, Shanghai, 200032, China|Renji Hospital, Shanghai Jiaotong University, Shanghai, Shanghai, China|Ruijing Hospital, Shanghai Jiaotong University, Shanghai, Shanghai, China|The First Affiliated Hospital of Xian Jiaotong University, Xian, Shanxi, China|The First Affiliated Hospital of Xinjiang Medical University, Ürümqi, Xinjiang, China|Hangzhou First Peoples Hospital, Hangzhou, Zhejiang, China|Sir Run Run Shaw Hospital, Zhejiang University School of Medicince, Hangzhou, Zhejiang, China

{ "Amylase Test": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT00613587

Roflumilast In-Vitro Basophil Release

https://clinicaltrials.gov/study/NCT00613587

COMPLETED

This study is looking for allergic asthmatics. Lung and allergy testing will be done to verify. If qualified, blood will be drawn for laboratory studies.

NO

Allergy|Asthma

Creighton University

Takeda

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RGT2007

2007-08

2010-01

2010-01

2008-02-13

2012-10-10

Creighton University Medical Center, Omaha, Nebraska, 68131, United States

{}

NCT00330187

Combined Pharmaco/Behavior Therapy in Adolescent Smokers

https://clinicaltrials.gov/study/NCT00330187

COMPLETED

In the current proposal, we intend to study the efficacy of bupropion SR with or without combined contingency management (CM) among adolescent cigarette smokers. The proposed study will test not only medication (bupropion SR), but also combination of medication and CM in potentially improving smoking cessation outcomes AND retention of adolescent smokers in the study. Hypothesis to be tested: Bupropion SR treatment will increase abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only. Hypothesis to be tested: Adolescent smokers treated with combined bupropion SR + contingency management (CM) treatment will have increased retention and increased abstinence rates when compared to bupropion SR alone or CM + placebo treated groups (as measured by decreased drop-out of participants, urine cotinine and continuous abstinence). Hypothesis to be tested: CM will increase the abstinence from cigarette smoking (as measured by urine cotinine and continuous abstinence) in adolescent smokers as compared to treatment with placebo only.

YES

Nicotine Dependence|Nicotine Use Disorder

DRUG: Bupropion SR|BEHAVIORAL: Contingency Management|OTHER: Placebo

Biologically-verified 7-day Point Prevalence Smoking Abstinence, Self-reported abstinence for the past 7 days, confirmed by urine cotinine ≤100 ng/mL, End of treatment (week 6)

Medical University of South Carolina

National Institute on Drug Abuse (NIDA)

ALL

CHILD, ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

DA17460|R01DA017460

2004-03

2009-07

2009-07

2006-05-26

2018-10-02

2018-10-02

Medical University of South Carolina, Charleston, South Carolina, 29425, United States

{ "Bupropion": [ { "intervention_type": "DRUG", "description": "Bupropion SR", "name": "Bupropion", "synonyms": [ "Bupropion", "Bupropion Hydrochloride", "Forfivo", "Bupropion, (+-)-Isomer", "Amfebutamone", "Quomen", "Zyntabac", "Zyban (Bupropion)", "(+-)-1-(3-Chlorophenyl)-2-((1,1-dimethylethyl)amino)-1-propanone", "Bupropion Hydrochloride, (+-)-Isomer", "Zyban (Anti-Smoking)", "Aplenzin", "Budeprion", "Zyban", "Wellbutrin" ], "medline_plus_id": "a695033", "generic_names": [ "Bupropion" ], "mesh_id": "D000077444", "drugbank_id": "DB01156", "wikipedia_url": "https://en.wikipedia.org/wiki/Bupropion" } ], "Contingency Management": [ { "intervention_type": "BEHAVIORAL" } ], "Placebo": [ { "intervention_type": "OTHER" } ] }

NCT00253487

Combination Chemotherapy and Radiation Therapy in Treating Younger Patients Who Are Undergoing an Autologous Stem Cell Transplant for Newly Diagnosed Gliomas

https://clinicaltrials.gov/study/NCT00253487

COMPLETED

RATIONALE: Drugs used in chemotherapy, such as temozolomide, busulfan, and O6-benzylguanine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. O6-benzylguanine may also help temozolomide work better by making tumor cells more sensitive to the drug. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy with a peripheral stem cell transplant or bone marrow transplant, using stem cells from the patient that are genetically-modified in the laboratory to protect them from the side effects of chemotherapy, may allow more chemotherapy to be given so that more tumor cells are killed. Giving combination chemotherapy and radiation therapy together with a peripheral stem cell transplant or bone marrow transplant may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating younger patients who are undergoing an autologous stem cell transplant for newly diagnosed gliomas.

NO

Brain and Central Nervous System Tumors

DRUG: O6-benzylguanine|DRUG: busulfan|DRUG: temozolomide|PROCEDURE: adjuvant therapy|PROCEDURE: autologous bone marrow transplantation|PROCEDURE: conventional surgery|PROCEDURE: peripheral blood stem cell transplantation|RADIATION: radiation therapy

Childrens Hospital Medical Center, Cincinnati

National Cancer Institute (NCI)

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

Allocation: |Intervention Model: |Masking: |Primary Purpose: TREATMENT

CCHMC-04660|CDR0000446082|NCI-7036

2005-08

2012-08

2012-08

2005-11-15

2014-01-06

{ "6-O-benzylguanine": [ { "intervention_type": "DRUG", "description": "O6-benzylguanine", "name": "6-O-benzylguanine", "synonyms": [ "O(6)-Benzylguanine", "6-O-benzylguanine", "O6-benzylguanine" ], "drugbank_id": "DB11919", "generic_names": [ "6-O-benzylguanine" ] } ], "Busulfan": [ { "intervention_type": "DRUG", "description": "busulfan", "name": "Busulfan", "synonyms": [ "n-Butane-1,3-di(methylsulfonate)", "1,4-Dimethanesulfonoxybutane", "Myl\u00e9ran", "1,4-Dimesyloxybutane", "Busulfano", "Glyzophrol", "Busulfex", "Busulphan", "Wellcome, Busulfan", "Mylecytan", "1,4-Butanediol dimethanesulfonate", "Busulfan", "Myelosan", "Busulfanum", "Busulfan Wellcome", "Tetramethylene bis(methanesulfonate)", "Myleran", "1,4-Bis(methanesulfonoxy)butane" ], "medline_plus_id": "a611033", "generic_names": [ "Busulfan" ], "mesh_id": "D019653", "drugbank_id": "DB01008" } ], "Temozolomide": [ { "intervention_type": "DRUG", "description": "temozolomide", "name": "Temozolomide", "synonyms": [ "Temozolomide", "Temodar", "Methazolastone", "3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-as-tetrazine-8-carboxamide", "Temozolomida", "CCRG 81045", "Temozolomidum", "Temcad", "TMZA-HE", "3-methyl-4-oxo-3,4-dihydroimidazo(5,1-d)(1,2,3,5)tetrazine-8-carboxamide", "8-Carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one", "B-39831", "Temozolodida", "3,4-dihydro-3-methyl-4-oxoimidazo(5,1-d)-1,2,3,5-tetrazine-8-carboxamide", "(S)-perillyl alcohol temozolomide", "T\u00e9mozolomide", "TMZ", "Temodal", "Temozolomid", "8-carbamoyl-3-methylimidazo(5,1-d)-1,2,3,5-tetrazin-4(3H)-one" ], "medline_plus_id": "a613002", "generic_names": [ "Temozolomide" ], "mesh_id": "D018906", "drugbank_id": "DB00853", "wikipedia_url": "https://en.wikipedia.org/wiki/Temozolomide" } ], "adjuvant therapy": [ { "intervention_type": "PROCEDURE" } ], "autologous bone marrow transplantation": [ { "intervention_type": "PROCEDURE" } ], "conventional surgery": [ { "intervention_type": "PROCEDURE" } ], "peripheral blood stem cell transplantation": [ { "intervention_type": "PROCEDURE" } ], "radiation therapy": [ { "intervention_type": "RADIATION" } ] }

NCT04637087

Precision Medicine in Ischemic Stroke and Atrial Fibrillation

https://clinicaltrials.gov/study/NCT04637087

PreMISe-AF

ACTIVE_NOT_RECRUITING

The overall goal of this study is to minimize morbidity due to Atrial Fibrillation (AF). The specific objective is to develop and implement a rational and personalized approach to AF risk estimation that can inform management decisions with ischemic stroke. The investigators propose to develop a clinical AF risk estimation tool in the electronic health record and to test the effectiveness of implementing a clinical AF risk estimation tool into care for use by stroke neurologists during the care of acute ischemic stroke patients at Massachusetts General Hospital. The investigators will evaluate cardiac monitoring utilization calibrated to AF risk by stroke neurologists using a custom electronic health record (EHR) notification module. The investigators hypothesize that cardiac rhythm monitoring utilization will be positively correlated with the predicted risk of AF.

NO

Atrial Fibrillation|Ischemic Stroke

OTHER: Atrial fibrillation risk electronic health record alert

Incidence of cardiac rhythm monitoring, Incidence of any cardiac rhythm monitoring in the 6-month follow-up period following discharge for an acute ischemic stroke. Cardiac rhythm monitoring will be ascertained based on electronic health record documentation., 6-months

Proportion of patients with implantable loop recorder orders, Proportion of patients with implantable loop recorder ordered at discharge, 6-months, and 12-months. Implantable loop recorder orders will be ascertained based on electronic health record documentation., 12-months|Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders, Proportion of patients with wearable cardiac rhythm monitor ordered at discharge, 6-months, and 12-months. Wearable cardiac rhythm monitoring orders will be ascertained based on electronic health record documentation., 12-months|Proportion of patients with cardiac monitor ordered by neurologist, Proportion of patients with cardiac monitor ordered by the neurologist at discharge. Cardiac monitor orders by the neurologist will be ascertained based on electronic health record documentation., 1-month|Proportion of patients with a new atrial fibrillation diagnosis, Proportion of patients with a new diagnosis of atrial fibrillation at 12-months following discharge for acute ischemic stroke based on electronic health record documentation., 12-months|Proportion of patients with recurrent stroke, Proportion of patients with recurrent stroke occurring within 12-months of discharge for an initial acute ischemic stroke. Recurrent stroke will be ascertained based on electronic health record documentation., 12-months|Proportion of patients deceased, Proportion of patients who die within 12-months of discharge for acute ischemic stroke. Death will be ascertained based on electroni health record documentation., 12-months|Proportion of patients with transesophageal echocardiogram utilization, Proportion of patients with transesophageal echocardiogram (TEE) within 3-months of discharge for acute ischemic stroke. Transesophageal echocardiogram utilization will be ascertained based on electronic health record documentation., 3-months|Proportion of patients with oral anticoagulation prescription, Proportion of patients with a new prescription for oral anticoagulation within 12-months of discharge following acute ischemic stroke. Prescriptions for oral anticoagulation will be ascertained based on electronic health record documentation., 12-months

Massachusetts General Hospital

Boston University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SCREENING

2020P001382

2021-03-11

2022-03-10

2024-07

2020-11-19

2024-05-28

Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

{ "Atrial fibrillation risk electronic health record alert": [ { "intervention_type": "OTHER" } ] }

NCT04903587

Gonadal Changes In Congenital Adrenal Hyperplasia Patients

https://clinicaltrials.gov/study/NCT04903587

UNKNOWN

To detect the prevalence of gonadal changes by US among the patients with CAH. * assess the patients radiological findings in relation to their hormonal profile. * early management and prevention of complications resulting from possible gonadal dysfunction.

NO

Congenital Adrenal Hyperplasia

DEVICE: Ultrasonography and MRI

prevalence of gonadal changes in CAH patients, By using US and MRI to detect the finding in gonades in CAH patients, baseline

Ain Shams University

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

US and MRI in CAH patients

2021-10-01

2022-10

2022-11

2021-05-26

2021-12-30

Ain Shams University, Cairo, Egypt

{ "Ultrasonography and MRI": [ { "intervention_type": "DEVICE" } ] }

NCT02172287

Multiple Dose Comparison of Tiotropium Inhalation Capsules, Salmeterol Inhalation Aerosol and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)

https://clinicaltrials.gov/study/NCT02172287

COPD

COMPLETED

To compare the long -term (six month) bronchodilator efficacy and safety of tiotropium inhalation capsules, salmeterol inhalation aerosol and placebo in patients with COPD. A secondary objective of this study was to compare the impact of tiotropium and salmeterol on humanistic and economic health outcomes, such as quality of life, patient preference and Health Resource Utilisation in this patient population.

NO

Pulmonary Disease, Chronic Obstructive

DRUG: Tiotropium (Ba679 BR)|DRUG: Salmeterol|DRUG: Placebo (for Tiotropium )|DRUG: Placebo (for Salmeterol)

Change from baseline in trough Forced expiratory volume in one second (FEV1) response, baseline, up to day 169|Change from baseline in Mahler Transitional Dyspnoea Index (TDI), baseline, up to day 169

Average Forced Expiratory Volume (FEV1) response on each test-day, 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169|Peak Forced Expiratory Volume (FEV1) response on each test-day, 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169|Trough Forced Vital Capacity (FVC) on each test day, 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169|Average Forced Vital Capacity (FVC) on each test day, 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169|Peak of Forced Vital Capacity (FVC) on each test day, 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169|Individual FEV1 measurements at each time point, 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169|Individual FVC measurements at each time point, 60 and 10 minutes before in-clinic dosing and at 30 minutes and 1, 2, 3, 4, 5, 6, 8, 10 and 12 hours post-dose on day 1, 15, 57, 113 and 169|Peak Expiratory Flow Rate (PEFR) measured by the patients at home, twice daily for 29 weeks|Change from baseline in Physicians global evaluation, baseline, day 15, 57, 113, 169 and 190|Change from baseline in Chronic Obstructive Pulmonary Disease (COPD) symptom score, baseline, day 15, 57, 113, 169 and 190|Amount of rescue medication (salbutamol) therapy used during the treatment period, up to day 169|Number and length of exacerbations of COPD during the treatment period, up to day 169|Number and length of hospitalisations for respiratory disease during the treatment period, up to day 169|Change from baseline in Quality of Life measures using St. Georges Respiratory Questionnaire (SGRQ), baseline, day 57, 113, 169 and 190|Health resource utilisation beyond the study protocol, up to day 190|Change in Patient preference measures (satisfaction with COPD medication), baseline, day 169|Change from baseline in Shuttle walking tests, baseline, day 57, 113, 169 and 190|Change from baseline in Borg dyspnea score, baseline, day 57, 113, 169 and 190|Number of patients with adverse events, up to day 190|Change from baseline Pulse rate and blood pressure, baseline, day 57, 113 and 169|Change from baseline in laboratory tests, baseline, day 169|Change from baseline in ECG, baseline, day 169

Boehringer Ingelheim

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT

205.130

1999-02

2000-05

2014-06-24

2014-06-24

{ "Tiotropium": [ { "intervention_type": "DRUG", "description": "Tiotropium (Ba679 BR)", "name": "Tiotropium", "synonyms": [ "", "Tiotropium", "Spiriva", "Tiotropium inhalers", "Spiriva Respimat", "Braltus", "Spiriva", "Spiriva", "Tiotropium bromide", "Tiotropium inhalers", "Spiriva Respimat", "Braltus", "Spiriva", "Spiriva", "Tiotropium bromide" ], "medline_plus_id": "a604018", "generic_names": [ "Tiotropium" ], "drugbank_id": "DB01409", "nhs_url": "https://www.nhs.uk/medicines/tiotropium-inhalers" }, { "intervention_type": "DRUG", "description": "Placebo (for Tiotropium )", "name": "Tiotropium", "synonyms": [ "", "Tiotropium", "Spiriva", "Tiotropium inhalers", "Spiriva Respimat", "Braltus", "Spiriva", "Spiriva", "Tiotropium bromide", "Tiotropium inhalers", "Spiriva Respimat", "Braltus", "Spiriva", "Spiriva", "Tiotropium bromide" ], "medline_plus_id": "a604018", "generic_names": [ "Tiotropium" ], "drugbank_id": "DB01409", "nhs_url": "https://www.nhs.uk/medicines/tiotropium-inhalers" } ], "Salmeterol": [ { "intervention_type": "DRUG", "description": "Salmeterol", "name": "Salmeterol", "synonyms": [ "Salmeterolum", "Serevent", "Aeromax", "Salmaterol", "Salmeterol" ], "medline_plus_id": "a695001", "generic_names": [ "Salmeterol" ], "drugbank_id": "DB00938", "wikipedia_url": "https://en.wikipedia.org/wiki/Salmeterol" } ], "Placebo (for Salmeterol)": [ { "intervention_type": "DRUG" } ] }

NCT05487287

Computational Assessment of Hand Motor Skills in Stroke Patients

https://clinicaltrials.gov/study/NCT05487287

UNKNOWN

This is a two phase prospective observational study that aims to validate the use of a motion capture software (Leap Motion) to measure and quantify functional deficits of the hand in stroke patients using a standard battery of exercises. The objectives of this study are: 1. To compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects. 2. To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients. 3. To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI. 4. To analyze changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life.

NO

Ischemic Stroke

DEVICE: Kinematic computational analysis of the hand (Leap Motion device)

Hand kinematic computational analysis, o compare the differences between results of hand kinematic computational analysis in patients with ischemic stroke and healthy subjects., First month|Relation between hand kinematic computational analysis and clinical scales, To analyze the relation between hand kinematic computational analysis and clinical scales usually performed to evalutate neurologic deficits in stroke patients., First month|Relation between hand kinematic computational analysis and stroke lesion on brain MRI., To analyze the relation between hand kinematic computational analysis and stroke lesion on brain MRI., First month|Results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life., Changes between results of hand kinematic computational analysis in the acute phase of stroke and at three months, and its relation with evolution of neurological evaluation clinical scales, functional clinical scales and quality of life., 1 month and three months

Instituto de Investigación Hospital Universitario La Paz

Hospital Universitario La Paz|Universidad Politecnica de Madrid

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

PI-4776

2021-05-13

2022-12-31

2022-12-31

2022-08-04

2022-08-04

Hospital Universitario La Paz, Madrid, 2846, Spain

{ "Kinematic computational analysis of the hand (Leap Motion device)": [ { "intervention_type": "DEVICE" } ] }

NCT02138487

Restricted Convalescence: Outcomes Following Urogynecologic Procedures

https://clinicaltrials.gov/study/NCT02138487

ReCOUP

COMPLETED

The investigators are conducting a study to better understand the relationship between activity restrictions and womens satisfaction following urogynecologic surgery for prolapse. We hypothesize that women with less stringent postoperative restrictions will have higher levels of satisfaction 12 weeks following surgery with no difference in respect to anatomic outcome.

NO

Pelvic Organ Prolapse

OTHER: liberal postoperative activity|OTHER: Restricted postoperative activity

Satisfaction, Satisfaction will be assessed following reconstructive pelvic surgery for prolapse using a question which assesses a patients global impression. Specifically, patients will be asked the question how satisfied are you with your prolapse surgery? at 12 wks to assess overall satisfaction. Possible responses include completely satisfied, mostly satisfied, neutral, mostly dissatisfied, and completely dissatisfied. , 12 weeks following surgery

Anatomic Outcomes, Anatomic outcomes will be assessed on physical examination 12 weeks and 1-year following reconstructive pelvic surgery., 12 weeks and 1 year following surgery|Quality of Life, Quality of life will be assessed using several validated questionnaires at 12 weeks and 1 year following reconstructive pelvic surgery for prolapse., 12 weeks and 1 year following surgery|Pain, Pain will be assessed using a visual analog scale at 12 weeks and 1 year following reconstructive pelvic surgery., 12 weeks and 1 year following surgery|Activity level, Activity level will be assessed using a validated questionnaire at 12 weeks and 1 year following reconstructive pelvic surgery., 12 weeks and 1 year

Northwestern University

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER

STU00084995

2014-08

2020-01

2020-01

2014-05-14

2020-06-04

Northwestern University, Feinberg School of Medicine, Chicago, Illinois, 60611, United States|University of Chicago, Chicago, Illinois, 60637, United States|Virginia Tech Carilion School of Medicine, Roanoke, Virginia, 24016, United States

{ "liberal postoperative activity": [ { "intervention_type": "OTHER" } ], "Restricted postoperative activity": [ { "intervention_type": "OTHER" } ] }

NCT05093387

SGT-53, Carboplatin, and Pembrolizumab for the Treatment of Metastatic Triple Negative Inflammatory Breast Cancer

https://clinicaltrials.gov/study/NCT05093387

WITHDRAWN

This phase I trial studies the effect of SGT-53, carboplatin, and pembrolizumab in treating patients with triple negative inflammatory breast that has spread to other parts of the body (metastatic). SGT-53 is a gene therapy that changes the deoxyribonucleic acid (DNA) of patients tumor cells to make it easier for the immune system to recognize them. SGT-53 targets the TP53 gene, which is frequently mutated in IBC cells. Chemotherapy drugs, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the bodys immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving SGT-53, pembrolizumab, and carboplatin may help the control the disease in patients with triple negative inflammatory breast cancer.

NO

Anatomic Stage IV Breast Cancer AJCC v8|Breast Inflammatory Carcinoma|Metastatic Triple-Negative Breast Carcinoma|Prognostic Stage IV Breast Cancer AJCC v8

DRUG: Carboplatin|BIOLOGICAL: Pembrolizumab|GENETIC: Transferrin Receptor-Targeted Liposomal p53 cDNA

Rate of Successful Administration, Assess feasibility of SGT-53 with carboplatin and pembrolizumab in metastatic triple negative IBC with a Combined Positive Score of ≥10 in PD-L1 expression., Up to 24 months|Clinical Benefit Rate, Evaluate preliminary activity of SGT-53 with carboplatin and pembrolizumab in metastatic triple negative IBC with a Combined Positive Score of ≥10 in PD-L1 expression, as measured by (complete response + particle response + stable disease >= 6 months using Response Evaluation Criteria in Solid Tumors criteria version 1.1)., Up to 3 cycles (each cycle = 21 days)

Incidence of adverse events, Measured by Common Terminology Criteria for Adverse Events version 5.0., Up to 28 (+/- 3 days) after last study treatment

Northwestern University

National Cancer Institute (NCI)

FEMALE

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT

NU 19B07|NCI-2021-09317|STU00212682|NU 19B07|P30CA060553

2022-11-10

2022-11-10

2022-11-10

2021-10-26

2022-11-15

Northwestern University, Chicago, Illinois, 60611, United States

{ "Carboplatin": [ { "intervention_type": "DRUG", "description": "Carboplatin", "name": "Carboplatin", "synonyms": [ "Carboplatino", "Carboplatin", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum(II)", "Paraplatin", "Carboplatine", "cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(II)", "CBDCA" ], "medline_plus_id": "a695017", "generic_names": [ "Carboplatin" ], "drugbank_id": "DB00958" } ], "Pembrolizumab": [ { "intervention_type": "BIOLOGICAL", "description": "Pembrolizumab", "name": "Pembrolizumab", "synonyms": [ "Keytruda", "Lambrolizumab", "Pembrolizumab" ], "medline_plus_id": "a614048", "generic_names": [ "Pembrolizumab" ], "drugbank_id": "DB09037", "wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab" } ], "Transferrin Receptor-Targeted Liposomal p53 cDNA": [ { "intervention_type": "GENETIC" } ] }

NCT01864187

Pharmacokinetics of Dexmedetomidine in Morbid Obesity

https://clinicaltrials.gov/study/NCT01864187

UNKNOWN

Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects. The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of the drug in these people is still unknown.This research was designed to study the pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.

NO

Obesity

DRUG: Dexmedetomidine

Plasma Concentration of dexmedetomidine, 0, 5, 10, 15, 20, 25, 30, 45 , 60, 90, 120, 150,180,240,360,480 hours post-dose

Guangzhou General Hospital of Guangzhou Military Command

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

Morbid Obesity

2013-06

2015-07

2015-07

2013-05-29

2015-03-12

Guangzhou Military Region General Hospital, Department of Anesthesiology, Guangzhou, Guangdong, 510010, China

{ "Dexmedetomidine": [ { "intervention_type": "DRUG", "description": "Dexmedetomidine", "name": "Dexmedetomidine", "synonyms": [ "Hydrochloride, D", "Dexmedetomidinum", "exmedetomidine", "Igalmi", "Dexmedetomidine Hydrochloride", "Sedadex", "Sileo", "MPV 1440", "Dexm\u00e9d\u00e9tomidine", "Dexdomitor", "Cepedex", "MPV1440", "Dexmedetomidina", "Precedex", "Dexmedetomidine", "(+)-4-((S)-alpha,2,3-Trimethylbenzyl)imidazole", "Dexmedetomidin", "(+)-4-((S)-\u03b1,2,3-trimethylbenzyl)imidazole", "Dexdor", "MPV-1440" ], "mesh_id": "D058647", "generic_names": [ "Dexmedetomidine" ], "drugbank_id": "DB00633" } ] }

NCT03363087

High Density Scar Guided Atrial Fibrillation Mapping

https://clinicaltrials.gov/study/NCT03363087

HD-SAGA

UNKNOWN

HD SAGA: There is increasing evidence that having AF is associated with some scarring of the upper chamber of the heart, the left atrium. There is also evidence that the amount of scarring can predict ablation success rates. Recently, rapid ultra high density mapping equipment has become available and this has the capability of defining the electrical scar in the atrium in detail. The equipment used to do this is standard approved equipment for the procedure but its use for making scar maps has not been fully assessed. In the mapping phase of the study therefore, the aim will be to collect high density scar maps in AF and normal rhythm to see how they compare. Maps will be collected in different ways to see if that changes their accuracy. The study will also assess if the values previously suggested as representing scar with lower density mapping systems are still appropriate where high density mapping equipment is used. The results from this study will help to improve the understanding of scar in the atrium and help demonstrate the most efficient way to collect scar information using this high density mapping equipment. In the future, clinicians may be able to use these very detailed scar maps to tailor and refine the way they ablate patients with AF, though the focus of the current study is just on collecting the scar information. While identifying areas requiring ablation is important to an ablation procedure, the other important aspect is the efficacy of ablation. Until now, we have been reliant on assessing our inputs into an ablation (such as the level of contact and the power delivered) but have been limited in the assessment of the output of an ablation in terms of lesion characteristics. New ablation catheter technology is now available which can assess the localised impedance drop with ablation. This is likely a better surrogate for lesion parameters than what we have previously had available and merits further study. Based on such study, we may be able to define targets for ablation which would help to guide future ablations. HD SAGA S: Approval amendment March 2021 In addition to the above, using new catheter technology incorporating contact force into the assessment of ablation lesion efficacy. HD SAGA H: Approval amendment March 2021 Using new mapping catheter (HD Grid) and algorithms (HD Wave) to compare scar maps between AF and SR and pre-establish pulmonary vein isolation lines.

NO

Atrial Fibrillation

DEVICE: Mapping and ablation|DEVICE: Mapping

Scar Volume, Quantification of scar volumes - presented as a proportion of the total atrial geometry volume, Through study completion, an average of 1 year|Impedance values with ablation, Collection of localised and conventional impedance during ablation, Through study completion, an average of 1 year|Scar volume and pulmonary vein isolation line gaps, Scar volume and pulmonary vein isolation line gaps between AF and SR, Through study completion, an average of 1 year

Confirm Scar Thresholds, Pacing threshold in mV will be assessed at different levels of atrial scar, Through study completion, an average of 1 year|Compare scar volumes in AF and sinus rhythm in the same patient, Quantitative comparison - comparing the scar areas in cm2 between the two maps, Through study completion, an average of 1 year|Compare maps generated using internal unipolar reference and Wilsons Central Terminus, Quantitative comparison - comparing the scar areas in cm2 between the two maps, Through study completion, an average of 1 year|Localised impedance fall during ablation, Compare the LI fall versus time relationship to assess the nature of the relationship with the aim of generating a target for LI fall with ablation, Through study completion, an average of 1 year|Localised impedance fall versus electrogram attenuation, Compare the LI impedance fall with ablation with electrogram attenuation (on microelectrodes) to further provide evidence for an LI target, Through study completion, an average of 1 year|Localised impedance fall versus pacing capture, Compare the LI impedance fall with ablation with loss of acing capture during ablation to further provide evidence for an LI target, Through study completion, an average of 1 year|Compare localised with conventional impedance values during ablation, Compare localised with conventional impedance values during ablation, Through study completion, an average of 1 year|Compare contact force measurements to local impedance, Compare contact force (grams) measurements to local impedance (ohms) during ablation to establish if increasing levels of contact force result in greater local impedance drops, Through study completion, an average of 1 year|Compare left atrial scar area between omnipolar and bipolar mapping in atrial fibrillation, Quantative comparison in cm2 of the level of atrial scar between 2 types of map in atrial fibrillation, Through study completion, an average of 1 year|Compare left atrial scar area between omnipolar and bipolar mapping in sinus rhythm, Quantative comparison in cm2 of the level of atrial scar between 2 types of map in sinus rhythm, Through study completion, an average of 1 year|Compare left atrial scar area in omnipolar maps between sinus rhythm and atrial fibrillation, Quantative comparison in cm2 of omnipolar maps between two heart rhythms, Through study completion, an average of 1 year|Compare left atrial scar areas in bipolar maps between sinus rhythm and atrial fibrillation, Quantative comparison in cm2 of bipolar maps between two heart rhythms, Through study completion, an average of 1 year|Compare identification of pulmonary vein isolation gaps between omnipolar and bipolar maps, Identifiying the presence of gaps within previously created pulmonary vein isolation lines between omnipolar and bipolar mapping, Through study completion, an average of 1 year|Compare identification of pulmonary vein isolation gaps between sinus rhythm and atrial fibrillation, Identifiying the presence of gaps within previously created pulmonary vein isolation lines between different heart rhythms within the same patient, Through study completion, an average of 1 year

University Hospital Southampton NHS Foundation Trust

Boston Scientific Corporation|Abbott

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC

RHM CAR0523

2019-08-27

2024-02

2024-02

2017-12-06

2022-06-23

University Hospital Southampton, Southampton, Hampshire, SO16 6YD, United Kingdom

{ "Mapping and ablation": [ { "intervention_type": "DEVICE" } ], "Mapping": [ { "intervention_type": "DEVICE" } ] }

NCT03195387

Chemoprotective Activity of MMV390048 in PfSPZ Challenge Model

https://clinicaltrials.gov/study/NCT03195387

WITHDRAWN

This study follows a First-In-Human dose-escalation study of MMV390048 (5 to 120 mg MMV390048 powder-in-bottle formulation), a formulation bioavailability study to establish suitable tablet formulation, and a two-part dose-escalation (40 to 120 mg of MMV390048) / induced blood stage malaria (ISBM) challenge study with the new tablet formulation. After identification of the predicted efficacious MMV390048 plasma concentrations in the IBSM model, the current study will evaluate the chemoprotective efficacy of MMV390048 in a standardised and validated controlled human malaria infection (CHMI) model using direct venous inoculation (DVI) of aseptic, purified, cryopreserved, vialed P. falciparum sporozoites (PfSPZ Challenge). Three sequential cohorts of healthy men and women of non-childbearing potential (WONCBP) will be administered the investigational medicinal product (IMP, i.e. MMV390048) under different conditions. This may identify preventative regimens, to be further investigated in a Phase II program. In the first two cohorts, protective administration of the IMP will occur 1 and 7 days before DVI of PfSPZ challenge. The timing of IMP administration and dosage in the last cohort will be determined on the basis of emerging data from the preceding cohorts, but will not exceed 28 days prior to the challenge nor 120 mg MMV390048.

NO

Malaria,Falciparum

DRUG: MMV390048

Cohort-specific geometric mean time to parasitaemia, Defined by a positive thick blood smear (with 2 qualified microscopists detecting 2 unambiguous parasites each) or qPCR (three positive measurements, each at least 12 hours apart and one with parasitaemia greater 100 parasites per mL), or Day 28 if there is no parasitaemia., Up to 28 days

Incidence, severity and relationship to MMV390048 of the observed and self-reported treatment-emergent adverse events, Safety and tolerability assessments during 29 days after administration of a single oral dose of IMP., Until Day 29 after IMP administration (cohort-dependent)|Malaria clinical score and incidence, severity and relationship of the observed and self-reported adverse events after PfSPZ challenge, Safety and tolerability of the PfSPZ challenge in non-immune healthy volunteers., From PfSPZ challenge to the day of positive parasitaemia and to Day 28 and Day 60 (EOS visit)|Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUClast), Estimation of PK parameters using non-compartmental methods after a single oral dose of MMV390048., Duration of the PK study is up to 29 days after IMP administration|Area under the plasma concentration-time curve from time zero to infinity (AUCinf), Estimation of PK parameters using non-compartmental methods after a single oral dose of MMV390048., Duration of the PK study is up to 29 days after IMP administration|Maximum plasma drug concentration (Cmax), Estimation of PK parameters using non-compartmental methods after a single oral dose of MMV390048., Duration of the PK study is up to 29 days after IMP administration|Time to reach maximum plasma drug concentration following administration (Tmax), Estimation of PK parameters using non-compartmental methods after a single oral dose of MMV390048., Duration of the PK study is up to 29 days after IMP administration|Elimination half-life (t1/2), Estimation of PK parameters using non-compartmental methods after a single oral dose of MMV390048., Duration of the PK study is up to 29 days after IMP administration|Apparent total drug clearance from plasma after oral administration (CL/F), Estimation of PK parameters using non-compartmental methods after a single oral dose of MMV390048., Duration of the PK study is up to 29 days after IMP administration|Apparent volume of distribution during terminal phase (Vz/F), Estimation of PK parameters using non-compartmental methods after a single oral dose of MMV390048., Duration of the PK study is up to 29 days after IMP administration|MMV390048 plasma concentration upon PfSPZ challenge, Estimation of MMV390048 plasma concentration on the day of PfSPZ inoculation., One-off assessment|Time to installment of parasitaemia, Characterisation of the relationship between MMV390048 exposure and time of installment of P. falciparum parasitaemia assessed by qPCR after PfSPZ challenge., Up to 28 days

Parasite multiplication rate during early asexual blood stage, Estimation of the effect of MMV390048 on sporozoite multiplication rate by qPCR and statistical modelling., Day 0 to day 60

Medicines for Malaria Venture

Datamap|PrimeVigilance Zagreb|ICON Clinical Research|Sanaria Inc.|PTx Solutions Ltd., UK|University of Cape Town

ALL

ADULT

PHASE1

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

MMV_MMV390048_17_01|2017-002034-23

2018-01

2018-09

2018-12

2017-06-22

2018-02-05

Institute of Tropical Medicine / Centre for Clinical Trials, Eberhard Karls University, Tübingen, 72074, Germany

{ "MMV390048": [ { "intervention_type": "DRUG" } ] }

NCT03152487

Trial Comparing EUS-guided Radiofrequency Ablation vs. EUS-guided Celiac Plexus Neurolysis

https://clinicaltrials.gov/study/NCT03152487

COMPLETED

Pancreatic cancer is the second most common gastrointestinal malignancy. Abdominal discomfort is a main symptom in patients with pancreatic cancer. Approximately 75% have pain at diagnosis and over 90% in advanced stages. Pain control is an important part of the plan of care for patients with pancreatic cancer.. The celiac plexus is a group of nerves that supply organs in the abdomen. EUS-guided celiac plexus neurolysis (EUS-CPN) has been widely used for pain management in patients with pancreatic cancer. Radiofrequency ablation of celiac ganglia or celiac plexus (EUS-RFA) is also being performed to alleviate abdominal pain in pancreatic cancer patients. However currently no comparative studies exist comparing EUS-CPN with EUS-RFA. The purpose of the study is to compare EUS-CPN with EUS-RFA for pain management in pancreatic patients, in order to determine which technique is better at improving pain in pancreatic cancer patients.

NO

Pancreatic Carcinoma Metastatic|Pancreatic Adenocarcinoma|Pancreatic Neoplasms|Pancreatic Cancer|Pancreatic Cancer, Adult

OTHER: Celiac Plexus Neurolysis|OTHER: Radiofrequency Ablation

Subject assessment of abdominal pain, Abdominal pain will be assessed with pain scores from the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Pancreatic Cancer module (QLQ-PAN26). The questionnaire has 26 questions with scoring ranging from a minimum of 26 to a maximum of 104. The higher the score, the worse the subjects quality of life rating., Baseline to 4 week follow up

Subject assessment of Quality of Life., Quality of life (QOL) as assessed by the quality of life instrument: the Functional Assessment of Cancer Therapy, Pancreatic Cancer (FACT-PA) (i.e. QLQ-30 and PAN-26), Baseline; 2 week follow up; 4 week follow up|Narcotic Use, Subjects will be asked about their medication usage to manage pain and the answers will be documented., Initial visit; 2 week follow up; 4 week follow up|Crossover to alternate technique, Cross-over to the alternate technique due to inadequate response to the original technique (defined as < 50% decrease in VAS score post-original technique)., 48 hours post procedure; 2 week follow up; 4 week follow up|Adverse effects, and endoscopic adverse events, Information regarding complications if any, that the subject may have experienced, which can include hypotension, diarrhea, neuropathic pain, paraplegia and endoscopic adverse events, 48 hours post procedure; 2 week follow up; 4 week follow up|Survival rate, Information regarding if the subject is alive or deceased., 2 week follow up; 4 week follow up|Pain per the VAS tool., Abdominal pain will be assessed with a standardized 11-point continous visual analog pain scale (with 0 equaling no pain, 5 moderate pain and 10 worst pain ever., Baseline; 48 hour post procedure; 2 week follow up; 4 week follow up

AdventHealth

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

1035541

2017-04-24

2018-04-01

2018-08-01

2017-05-15

2019-02-11

Center for Interventional Endoscopy - Florida Hospital, Orlando, Florida, 32803, United States

{ "Celiac Plexus Neurolysis": [ { "intervention_type": "OTHER" } ], "Radiofrequency Ablation": [ { "intervention_type": "OTHER" } ] }

NCT02814487

MSFC Versus DAM. A Smartphone Application for Multiple Sclerosis Self-assessment.

https://clinicaltrials.gov/study/NCT02814487

DAM

COMPLETED

Multiple Sclerosis Functional Composite score (MSFC) is one of the gold standard for multiple sclerosis (MS) patient clinical evaluation. However, its practical implementation is not always optimal as it can prove to be very time consuming. Moreover, it often constrains the range of tests used and is not a particularly good marker for patient real life disability status. A mobile application called Digital Self-Assessment for Multiple Sclerosis (DAM) was developed in order to replicate each of MSFC tests available in order to assess MS progression in the patient environment.

NO

Multiple Sclerosis

correlation between the MSFC score and the DAM score, At Day 0

correlation between the DAM score, At Day 0 and Day 30|correlation between the DAM score, At Day 60 and Day 90|correlation between the the MSFC and the DAM score, At Day 90

Ad scientiam

Roche Pharma AG

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

P003

2015-12

2016-09

2016-09

2016-06-27

2016-09-12

{}

NCT04419987

Study of Constitutional Platelet Disease

https://clinicaltrials.gov/study/NCT04419987

EVGPP

NOT_YET_RECRUITING

Platelets are circulating blood cells. They bind to each other and to the wall of the damaged vessel to prevent excessive blood loss. Platelets can be : * insufficient in number in the case of thrombocytopenia; * or non-functional in the case of thrombopathy. Constitutional thrombopathies and thrombopenias are rare diseases. Constitutional thrombopenias cause haemorrhage of variable intensity and are sometimes a sign of more serious haematological pathologies. The evolutionary risk of some constitutional thrombopenias is the appearance of myelofibrosis, dysmyelopoiesis or malignant proliferation. While the evolutionary stakes of some thrombopenias and especially syndromic thrombopenias will be more likely to affect other organs (kidney, heart, bones, brain, ...), other constitutional thrombopenias will have few consequences. Their diagnosis will then have the major challenge of distinguishing them from immunological thrombopenias and avoiding the use of inappropriate and sometimes severe treatments (corticosteroids, IV immunoglobulins, immunosuppressants, splenectomy). Mutations in more than forty genes have been identified to date and are responsible for thrombocytopenia. Constitutional thrombopathies are heterogeneous and may involve different platelet constituents. In short, when platelets are stimulated at a lesion site, various soluble or matrix agonists bind to platelet receptors to induce calcium flow, secretion and platelet aggregation at a vascular gap to prevent blood loss. Constitutional thrombopathies are primarily at risk of spontaneous or induced mucocutaneous bleeding. Some thrombopathies are also part of more complex syndromic patterns. In recent decades, considerable progress has been made in the understanding of thrombopathies, enabling them to be better identified. Details have been provided on platelet dysfunctions linked to abnormalities in the processes of granule biogenesis and secretion, and to signalling defects (in particular surface receptor deficiency). Currently, more than thirty genes are the site of autosomal dominant, recessive or X-linked mutations and can be sequenced.

NO

Blood Platelet Disease

GENETIC: draw blood

Adhesion, Isolated wafers are deposited on substrate coated plates, the wafers adhere to the substrate. Then the number of adherent wafers will be counted by cell imaging. Several substrates will be tested., 5 years|Study of platelet protein expression, A western blot will be made from the platelet lysate, allowing the detection of specific proteins with the help of antibodies directed against the proteins of interest. A semi-quantitative analysis of these proteins will be performed by chemiluminescence., 5 years

Assistance Publique Hopitaux De Marseille

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC

2019-30

2020-07-20

2020-12-20

2025-06-01

2020-06-09

2020-07-09

{ "draw blood": [ { "intervention_type": "GENETIC" } ] }

NCT02674087

Prospective Monitoring of Children Born in Haute Vienne From Uterine Life to Adulthood

https://clinicaltrials.gov/study/NCT02674087

NEHAVI

UNKNOWN

The purpose of this survey is to collect data from intrauterine life until the age of 18 of children born in Haute Vienne. The interest to realize such survey is to find correlations and interactions that may exist between the events that occurred during intrauterine life and those that will occur after the birth of the child. The investigators will examine every aspect of these childrens lives from the perspectives of health, social sciences and environmental health These are medical events (occurrence of disease, medication), but also socio-cultural for this child (living environment, exposure to possible contaminants, events in family history). This cohort aims to include 3000 children a year (whose parents consented to their inclusion), all born at Haute-Vienne.

NO

Child Development

Rate of enrollment, 3 years after the study has started, the investigators will evaluate the rate of enrollment., At 3 years

University Hospital, Limoges

Fondation Patrtenariale Unilim|ARS|La poste

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

I1 029

2014-04

2018-04

2019-04

2016-02-04

2016-02-04

Clinique des Emailleurs, Limoges, 87000, France|HME, Limoges, 87000, France|Centre Hositalier de Saint Junien, Saint Junien, 87000, France

{}

NCT01879787

Effects of tDCS Combined With mCIMT or Mental Practice in Poststroke Patients

https://clinicaltrials.gov/study/NCT01879787

COMPLETED

This study aims to evaluate systematically and controlled the effectiveness of mental practice techniques and modified constraint- induced movement therapy (mCIMT)in the treatment of post-stroke patients with motor deficit in the upper limb. As well as finding a protocol of transcranial direct current stimulation(tDCS)that will maximize the effects of the practice of mental image and mCIMT. To this end, the subjects included will be submitted to 12 therapy sessions with active or sham tDCS combined with at least one of the following techniques: conventional physiotherapy, mental practice technique or mCIMT

NO

Stroke

OTHER: tDCS

Change from Fugl-Meyer Assessment of Upper Extremity Motor Function, The Fugl-Meyer assessment was used to measure recovery of motor control. It is a 226-point scoring system that includes range of motion, pain, sensation, motor function of the upper and lower extremities, and balance.This instrument provides a reliable and valid measure of specific motor function that is also sensitive to change., At baseline, 1 month and 2 month

Change from Motor Activity Log, The MAL is a scripted, structured interview to measure real-world upper extremity function. It was developed to measure the effects of therapy on the more impaired arm following stroke. The original MAL consists of 14 activities of daily living (ADLs) such as using a towel, brushing teeth, and picking up a glass. For a specified time period post-stroke, the individual is asked about the extent of the activity performed and how well it was performed by the more impaired arm. The response scale ranges from 0 (never used) to 5 (same as pre-stroke). The mean of the scores for frequency of the activity comprises the Amount of Use (AOU) scale; the mean of the scores for how well the activity was performed comprises the Quality of Movement (QOM) scale. Ideally, ratings are obtained from the individual with a stroke as well as a knowledgeable informant (caregiver)., At baseline, 1 month and 2 month

Change from Jebsen-Taylor Hand Function Test, The Jebsen-Taylor function test was designed to provide a short, objective test of hand functions commonly used in activities of daily living (ADLs). The target patient population includes adults with neurological or musculoskeletal conditions involving hand disabilities, although there may be other patient populations with other hand dysfunctions which may be appropriate. The test was developed to be used by health professionals working in restoration of hand function. It consists of seven items that include a range of fine motor, weighted and non-weighted hand function activities, At baseline, 1 month and 2 months

Universidade Federal de Pernambuco

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

tDCS_mCIMT_MP_Stroke

2011-01

2013-08

2014-12

2013-06-18

2015-04-13

Applied Neuroscience Laboratory, Recife, Pernambuco, 50740-560, Brazil

{ "tDCS": [ { "intervention_type": "OTHER" } ] }

NCT00352287

Study to Determine the Effects of Human Growth Hormone and Pioglitazone in Overweight, Prediabetic Adults

https://clinicaltrials.gov/study/NCT00352287

COMPLETED

The purpose of the study was to determine the effects of growth hormone and an insulin sensitizer drug in pre-diabetic adults with excessive amounts of abdominal fat. Participants received a combination of two drugs: (1) recombinant human growth hormone (or its placebo) and (2) pioglitazone (or its placebo). We measured the abdominal fat content and blood sugar levels of participants before and after 40 weeks of treatment.

NO

Obesity|Metabolic Syndrome|Impaired Glucose Tolerance

DRUG: Recombinant human growth hormone; pioglitazone

Visceral fat content was quantified by CT scan, glucose tolerance was assessed using a 75 gm OGTT and insulin sensitivity was measured using steady-state plasma glucose (SSPG) levels obtained during an insulin suppression test.

Body mass index (BMI), anthropometric measurements, glycohemoglobin and lipid measurements were performed before and after 40 weeks of treatment.

Stanford University

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE|Primary Purpose: TREATMENT

78235|1F32-AG02142-1, 5F32-AG02142-2

2003-03

2005-04

2006-07-14

2006-07-14

Veterans Affairs Palo Alto Health Care System, Palo Alto, California, 94304, United States

{ "Pioglitazone": [ { "intervention_type": "DRUG", "description": "Recombinant human growth hormone; pioglitazone", "name": "Pioglitazone", "synonyms": [ "AD-4833", "AD 4833", "U-72107A", "(\u00b1)-5-((4-(2-(5-ethyl-2-pyridinyl)ethoxy)phenyl)methyl)-2,4-thiazolidinedione", "Actos", "Pioglitazone Hydrochloride", "AD4833", "U 72107A", "5-{4-[2-(5-ethylpyridin-2-yl)ethoxy]benzyl}-1,3-thiazolidine-2,4-dione", "5-(4-(2-(5-Ethyl-2-pyridyl)ethoxy)benzyl)-2,4-thiazolidinedione", "U72,107A", "Pioglitazona", "Pioglitazonum", "U72107A", "Pioglitazone" ], "medline_plus_id": "a699016", "generic_names": [ "Pioglitazone" ], "nhs_url": "https://www.nhs.uk/medicines/pioglitazone", "mesh_id": "D007004", "drugbank_id": "DB01132" } ] }

NCT01557387

Real-time Diagnosis of Pseudopolyps During Colonoscopy

https://clinicaltrials.gov/study/NCT01557387

COMPLETED

Significance: Biopsy of potentially benign pseudopolyps and the surrounding mucosa adds expense and prolongs the time of endoscopic procedures. Use of endoscopic technologies could decrease the need and expense of endoscopic biopsy for these lesions. Hypothesis: Pseudopolyps will have a distinctive pattern with the specialized imaging techniques of high definition imaging, narrow band imaging, and endoscopic dye-spraying techniques using indigo carmine which will predict diagnosis without biopsy. 100 patients with inflammatory bowel disease will be enrolled in the study. Following a standard bowel preparation, each patient will be evaluated using standard endoscopic equipment. All patients will receive a standard bowel preparation (sodium phosphate, PEG-3350, or magnesium citrate based preparations). All colonoscopic evaluations will be performed for indications unrelated to the present study, including evaluation of response to medical treatment, routine surveillance exams for dysplasia, diarrhea, or rectal bleeding. Polypoid lesions will be examined using four consecutive methods: (a) high definition white light, (b) narrow band imaging, (c) chromoendoscopy (high definition white light with indigo carmine dye-spraying), and (d) histologic examination following biopsy. The flat mucosa surrounding the polypoid lesions will also be examined using theses four techniques in an effort to identify dysplastic tissue associated with these polypoid growths. High definition white light is the standard imaging modality used for colonoscopy. Narrow band imaging (blue wavelength of light) is also used routinely and is available on all current generation colonoscopes with the press of a button. Our division routinely uses chromoendoscopy as part of surveillance for dysplasia in patients with inflammatory bowel disease. Dye spraying catheters or flushing will be utilized for dye application to mucosa. The dye used will be indigo carmine. Directed biopsy specimens will then be performed using a multibite forceps for targeted biopsies. Routine biopsies will be performed as clinically indicated. Pathology slides will be reviewed by the gastrointestinal pathologists at the University of Miami. The gastroenterologists interpretation based on each of the three successive endoscopic methods will then be compared to the histologic evaluation with each individual lesion serving as its own control.

NO

Pseudopolyp|Inflammatory Bowel Disease

OTHER: Endoscopic techniques

Accuracy of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis, 2 years or until 100 patients enrolled, whichever comes first

Cost of non-invasive endoscopic techniques for diagnosis of pseudopolyps as compared to histology as the gold standard for diagnosis, 2 years or until 100 patients enrolled, whichever comes first

University of Miami

Olympus America, Inc.

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

20091017

2011-09

2013-02

2013-02

2012-03-19

2018-08-03

University of Miami Hospital and Clinics, Miami, Florida, 33136, United States|University of Miami Hospital, Miami, Florida, 33136, United States

{ "Endoscopic techniques": [ { "intervention_type": "OTHER" } ] }

NCT02369887

Evaluation of a Facility-based Test, Treat, and Prevent HIV Program Among Men Who Have Sex With Men and Transgender Women in Thailand

https://clinicaltrials.gov/study/NCT02369887

PrEP

COMPLETED

This is a prospective observational cohort study that aims to enroll a total of 2000 Thai MSM and TG at five health facilities in four provinces of Thailand. Each participant will be followed for 18 months. Baseline and historical rates of HIV testing/re-testing, initial CD4 counts, retention in care, and ART adherence at the study clinics, at the study clinics combined, and national data (if available) will be compared with rates after implementation of the Test and Treat strategy. Analysis will also include an assessment of HIV prevalence and incidence. This study will use similar objectives, indicators, and procedures as those used in an ongoing Test and Treat study by the Thai Red Cross AIDS Research Centre in three tertiary care hospitals, and a study to be conducted with PEPFAR Key Populations Implementation Science (KPIS) funding through United States Agency for International Development (USAID), in community-based centers, allowing comparison of uptake and follow-up of MSM and TG using the Test and Treat strategy in a variety of settings.

NO

PrEP Test and Treat

Pre-Exposure Prophylaxis of HIV, Participants must be Thai MSM or TG, aged 18 years or older, who report unprotected anal sex with a man during the previous 6 months, can read and write Thai, and are not known to be HIV-infected. To receive PrEP, participants must have a negative HIV test result, no signs or symptoms of acute HIV infection during the previous month, a creatinine clearance result > 60 ml/min, and no contraindication to PrEP medication., 36 months

Thai Red Cross AIDS Research Centre

Ministry of Health, Thailand

MALE

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Test and Treat PrEP

2014-09-15

2020-08-15

2023-02-16

2015-02-24

2023-02-17

Department of Disease Control (DDC), Ministry of Public Health (MOPH), Nonthaburi, 11000, Thailand

{}

NCT01604187

Procedural Pain Treatment With Transmucosal Sublingual Fentanyl Tablet in Colonoscopy Patients

https://clinicaltrials.gov/study/NCT01604187

Abstral

COMPLETED

Colonoscopy is generally considered an invasive procedure that causes remarkable pain to the patient. The pain associated with the procedure is not caused by the insertion of the scope but from inflating of the colon in order to do the inspection. It has been shown that colonoscopy can be performed successfully without sedation (Leung, 2010), but many patients feel discomfort during the procedure. Factors predicting a painful colonoscopy are female-gender, degree of patient nervousness and the technical difficulty of the colonoscopy (Ylinen et al. 2009). Also age under 40, previous abdominal surgery and use of sedation are associated with painful colonoscopy ( Seip et al. 2009). Most often sedation and/or analgesia are achieved by administering a benzodiazepine or a combination of a benzodiazepine and an opioid (Fanti et al. 2009, Maskelar et al. 2009,), dexmedetomidine (Dere et al. 2009) or by using non-pharmacologic methods (Amer-Cuenca et al. 2011). Tramadol as monotherapy did not significantly decrease pain intensity or endoscopists evaluation of colonoscopy (Grossi et al. 2004). Currently, intravenous midazolam is the drug used most commonly to introduce some sedation for colonoscopy. Intravenous sedation definitely increases the cost of procedure; drug administration, need for pulse oximetry monitoring and the need for follow-up after the procedure make colonoscopy sometimes expensive and troublesome. It has also been shown, that low-dose midazolam neither relieves discomfort nor makes patients forget it (Elphick et al. 2009). Fentanyl is a short-acting opioid widely used in anesthesia management. Transmucosal sublingual formulation of fentanyl has been developed to further improve the management of pain. When administered as a sublingual fast-dissolving tablet (Abstral®) that is placed under the tongue, the effects is fast and predictable. Its active ingredient is absorbed by the body through the mucous membrane. After administration of buccal fentanyl maximum plasma drug concentration was measured after 25 minutes (Darwish et al. 2011). Plasma fentanyl concentrations versus time following buccal and sublingual administration are very similar (Darwish et al. 2008). Abstral® sublingual tablets should be administered directly under the tongue at the deepest part. Sublingual administration is an easy and non-invasive method of pain treatment for the patient coming to colonoscopy done as an office based procedure. Other advantages compared to invasive methods are improved comfort of patients and no need for intravenous access because of pain relief. Before, it has been used in the management of breakthrough pain in cancer patients. Sublingual fentanyl is shown to be effective and well-tolerated for the treatment of breakthrough cancer pain (Uberall et al. 2011). The use of transmucosal tablet for colonoscopy patients is a quite new approach.

NO

Colonoscopy|Pain

DRUG: Fentanyl|DRUG: Placebo

Efficacy of fentanyl transmucosal tablet to placebo in patients having colonoscopy., Anxiety will be measured using NRS (0 = no anxiety, 10=maximal anxiety). Pain will be monitored by using numercal rating scale NRS (0-10), sedation by using NRS (0-10, 0= not sedated at all, 10=no response) . Nurses and surgeons satisfaction with the procedure will be evaluated using NRS (0-10). Adverse effects of opioids will be evaluated by patients using NRS (0-10)) for the following items: drowsiness (alert / very drowsy), pleasantness (very unpleasant / very pleasant feeling) and nausea/vomiting (no nausea / very strong nausea). In addition, all other adverse effects will be recorded.

The safety of fentanyl transmucosal tablet to placebo in patients having colonoscopy., SpO2 and breath rate will be followed throughout the procedure. If the peripheral arterial oxygen saturation decreases below 90 % or breath rate falls below 8 per min, additional oxygen will be given. In case of excess opioid effects, naloxon 0.1mg iv will will be given. The patients will be interviewed by telephone on the first day after the procedure approximately 24 hours later and.

Turku University Hospital

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER_GOV

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE

Abstral

2012-04

2019-04-22

2019-04-30

2012-05-23

2019-09-11

Turku University Hospital, Turku, 20521, Finland

{ "Fentanyl": [ { "intervention_type": "DRUG", "description": "Fentanyl", "name": "Fentanyl", "synonyms": [ "Fentanyl CII", "Abstral", "R 4263", "Fentanilo", "Phentanyl", "N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamide", "Fentora", "1-Phenethyl-4-(N-phenylpropionamido)piperidine", "Durogesic", "1-phenethyl-4-N-propionylanilinopiperidine", "Fentanyl", "R-4263", "R4263", "Transmucosal Oral Fentanyl Citrate", "N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide", "N-(1-phenethyl-4-piperidyl)propionanilide", "N-(1-phenethyl-4-piperidinyl)-N-phenylpropionamide", "N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide", "Lazanda", "Fentanil", "Fentanyl Citrate", "N-phenethyl-4-(N-propionylanilino)piperidine", "Sublimaze", "Fentanila", "Duragesic", "Fentanest", "Fentanylum", "Fentanyl Patch", "Duragesic", "Fentanyl Patch", "Duragesic" ], "medline_plus_id": "a612015", "generic_names": [ "Fentanyl", "Fentanyl Patch", "Fentanyl Patch" ], "nhs_url": "https://www.nhs.uk/medicines/fentanyl", "mesh_id": "D018686", "drugbank_id": "DB00813" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04737187

Phase III Study of Trifluridine/Tipiracil With and Without Bevacizumab in Refractory Metastatic Colorectal Cancer Patients

https://clinicaltrials.gov/study/NCT04737187

SUNLIGHT

COMPLETED

This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.

YES

Refractory Metastatic Colorectal Cancer

DRUG: Trifluridine/Tipiracil|DRUG: Bevacizumab

Overall Survival (OS), Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method., From date of randomization to the death due to any cause or cut-ff date, whichever comes first (maximum duration: up to 20 months)|Survival Probability at 6 Months, Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 6 months was reported., From date of randomization until 6 months post treatment|Survival Probability at 12 Months, Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 12 months was reported., From date of randomization until 12 months post treatment|Survival Probability at 18 Months, Overall survival defined as the observed time elapsed between the date of randomization and the date of death due to any cause. The primary estimand of interest was defined to assess the effect of the randomized treatments on the survival duration in all participants regardless of whether or not intercurrent events had occurred (treatment policy strategy). Analysis was performed using Kaplan- Meier method. In this outcome measure, data of survival probability at 18 months was reported., From date of randomization until 18 months post treatment

Progression Free Survival (PFS), PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method., From randomization to the date of radiological tumour progression or death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)|Probability of Participants With Progression Free Survival at 3, 6, 9 and 12 Months, PFS was defined as the time elapsed between the date of randomisation and the date of radiological tumour progression as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by investigator, or death (from any cause), whichever comes first. Progressive Disease (PD) as per RECIST 1.1: at least a 20 percent (%) increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions. Analysis was performed by Kaplan-Meier method. In this outcome measure, data of PFS at 3 months was reported., From randomization until 3, 6, 9, and 12 months post treatment|Overall Response Rate (ORR), Objective response was defined as percentage of participants who achieved complete response (CR) or partial response (PR) according to the RECIST version 1.1 and using investigators tumour assessment. As per RECIST 1.1, CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the Baseline sum diameters., From the date of randomization to the date of documentation of progression or death due to any cause or data cut-off, whichever occurred first (i.e., up to 20 months)|Percentage of Participants With Disease Control, Disease control is defined as percentage of participants who achieved CR or PR, or stable disease (SD) as per RECIST 1.1 and using investigators tumour assessment from the date of randomization to until disease progression or death due to any cause. As per RECIST 1.1, CR: disappearance of all target and non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: at least a 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters. PD: at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions., From randomization to the date of first documented tumor progression, death due to any cause or data cut-off date whichever comes first (i.e., up to 20 months)|Number of Participants With Treatment-emergent Adverse Events (TEAE) and Treatment-emergent Serious Adverse Events (TESAEs), An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (time from the first dose of study treatment up to 30 days after the last dose of study treatment). TEAEs included both SAEs and non-SAEs., From Baseline up to 30 days after the last dose of study treatments (i.e., up to 19.5 months)

Taiho Oncology, Inc.

Institut de Recherches Internationales Servier

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT

CL3-95005-007|2020-001976-14

2020-11-25

2022-07-19

2023-09-12

2021-02-03

2023-12-26

2023-12-26

Mayo Clinic Hospital, Phoenix, Arizona, 85054, United States|City of Hope, Duarte, California, 91010, United States|City of Hope - South Pasedena, South Pasadena, California, 91030, United States|City of Hope - Upland, Upland, California, 91786, United States|Mayo Clinic - FL, Jacksonville, Florida, 32224, United States|Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, 33140, United States|Comprehensive Hematology Oncology, Saint Petersburg, Florida, 33709, United States|DuPage Medical Group - Joliet Oncology-Hematology Associates, Joliet, Illinois, 60435, United States|Investigative Clinical Research of Indiana LLC, Noblesville, Indiana, 46062, United States|Oncology Hematology West, PC dba Nebraska Cancer Specialists, Omaha, Nebraska, 68130, United States|Mayo Clinic - Rochester, Rochester, New York, 55905, United States|Renovatio Clinical - El Paso, El Paso, Texas, 79915, United States| Medizinische Universität Graz , Graz, 8036, Austria| Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V , Innsbruck, 6020, Austria| Ordensklinikum Linz Barmherzige Schwestern Interne I , Linz, 4010, Austria| Landeskrankenhaus Feldkirch Interne E , Rankweil, 6830, Austria| Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK) , Salzburg, 5020, Austria| Landesklinikum Wiener Neustadt , Wiener Neustadt, 2700, Austria| Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie , Wien, 1090, Austria| OLV Ziekenhuis Oncology , Aalst, 9300, Belgium| Universitair Ziekenhuis Antwerpen Oncologie , Edegem, 2650, Belgium| UZ Leuven Campus Gasthuisberg Digestieve Oncologie , Leuven, 3000, Belgium| CHC Montlégia Oncologie , Liege, 4000, Belgium| AZ NIKOLAAS Oncology , Sint Niklaas, 9100, Belgium| Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica , Barretos, 14784-400, Brazil| Hospital de Base Centro Integrado de Pesquisa , Sao Jose Do Rio Preto, 15090-000, Brazil| ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa , Sao Paulo, 01246-000, Brazil|Hospital A C Camargo Unidade de Pesquisa Clinica Rua Antonio Prudente, Sao Paulo, 01509-900, Brazil|Hospital Albert Einstein Instituto de Ensino e Pesquisa Av Albert Einstein, Sao Paulo, 05652- 900, Brazil|Hospital Sao Camilo Nucleo de Pesquisa Av Alcantara Machado, São Paulo, 03102-002, Brazil| Aalborg Universitetshospital, Syd Onkologisk Afdeling , Aalborg, 9000, Denmark|Rigshospitalet Dpt of Oncology, Copenhagen, 2100, Denmark| Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling , Herning, 7400, Denmark| Odense Universitetshospital Department of Oncology , Odense, 5000, Denmark| CHU Jean Minjoz Service doncologie médicale , Besancon, 25030, France| CHU Morvan Institut de Cancérologie et dHématologie , Brest, 29200, France| Centre de lutte contre le cancer Francois Baclesse UCP Digestif , Caen, 14076, France|Hôpital Saint-Antoine Service dOncologie Médicale, Paris, 75012, France| Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive , Paris, 75015, France|CHU de Poitiers Pole Régional de Cancérologie, Poitiers, 86021, France|Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin, 10707, Germany|Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie, Berlin, 13353, Germany|Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei, Luebeck, 23562, Germany|Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III, Muenchen, 81377, Germany|Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly, Budapest, 1062, Hungary|Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly, Budapest, 1115, Hungary|Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet, Debrecen, 4032, Hungary|Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly, Győr, 9024, Hungary|Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont, Kecskemét, 6000, Hungary|Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika, Szeged, 6720, Hungary|JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum, Szolnok, 5004, Hungary|Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly, Szombathely, 9700, Hungary|Azienda Policlinico Universitaria - Presidio Monserrato Oncologia Medica Strada Statale 554 Sestu-Monserrato, Cagliari, Italiy, 9100, Italy|A.O.U. Seconda Universita degli Studi di Napoli U.O.C di Oncologia Medica e di Ematologia Dipartimento Medico di Internistica clinca e sperimentale F Magrassi - A. Lanzara Via Sergio Pansisni ,, Napoli, 80131, Italy|Istituto Nazionale Tumori, I.R.C.C.S Fondazione G Pascale Struttura Complessa di Oncologia Medica Addominale, Napoli, 80131, Italy|Istituto Oncologico Veneto IOV - IRCCS Unita Operativa Complessa Oncologia Medica 1 Via Gattamelata 64, Padova, 35128, Italy|A.O.U. Pisana-Ospedale Santa Chiara U.O. di Oncologia Medica 2, Pisa, 56126, Italy|Ospedale San Carlo U.O. Oncologia Medica Via Potito Petrone, Ctr Macchia Romana, Potenza, 85100, Italy|Arcispedale Santa Maria Nuova Unità di Oncologia, Reggio Emilia, 42123, Italy|Istituto Clinico Humanita IRCCS Dipartimento di Oncologia Medica ed Ematologia Via Manzoni,, Rozzano (MI), 20089, Italy|IRCSS Casa Sollievo della Sofferenza Dipartimento Onco-Ematologia Vale Cappuccini 1, San Giovanni Rotondo, 71013, Italy|Przychodnia Lekarska KOMED , Konin, 62-500, Poland|SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii, Krakow, 31-531, Poland|Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej, Opole, 45-061, Poland|Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o., Słupsk, 76-200, Poland|Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii, Warszawa, 02-034, Poland|Wojskowy Instytut Medyczny Klinika Onkologii, Warszawa, 04-141, Poland|Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii, Warzszawa, 02-507, Poland|Pan American Center for Oncology Trials, LLC, Río Piedras, 00935, Puerto Rico|Arkhangelsk Clinical Oncology Dispensary chemotherapy department, Arkhangelsk, 163045, Russian Federation|Clinical Oncology Dispensary No.1 Chemotherapy Department, Krasnodar, 350040, Russian Federation|Moscow City Oncology Hospital # 62 chemotherapy department, Moscow Region, 143423, Russian Federation|Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy, Moscow, 115478, Russian Federation|University Headache Clinic Outpatient oncology clinic, Moscow, 121467, Russian Federation|Omsk Clinical Oncologic Dispensary Chemotherapy, Omsk, 644046, Russian Federation|National Medical Research Center of Oncology N.N. Petrova, Saint-petersburg, 197758, Russian Federation|Multidisciplinary clinic Reaviz, Samara, 443011, Russian Federation|Oncology dispensary No.2 Oncology department, Sochi, 354057, Russian Federation|Scientific Centre for Specialized Medical Care (oncological) Chemotherapy, St Petersburg, 115478, Russian Federation|Saint Petersburg City Oncology Clilnic, St Petersburg, 198255, Russian Federation|SBIH of YR Clinical oncology hospital chemotherapy department , Yaroslavl, 150054, Russian Federation| H. Valle de Hebrón Servicio de Oncología - (VHIR) , Barcelona, 08035, Spain| Hospital de la Santa Creu I Sant Pau Oncología Medica , Barcelona, 08041, Spain| Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica , Cordoba, 14004, Spain| INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica , Hospitalet de Llobregat, 08908, Spain| Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica , Madrid, 28034, Spain| HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica , Madrid, 28041, Spain| Hospital Universitario Marqués de Valdecilla oncología medica , Santander, 39008, Spain|H.VIRGEN DEL ROCIO Servicio de Oncología Médica, Sevilla, 41013, Spain|H. GENERAL DE VALENCIA Servicio de Oncología Médica, Valencia, 46014, Spain|Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médical, Zaragoza, 50009, Spain|Kyiv City Clinical Oncological Centre, Kiev, Ukrain, 03115, Ukraine|Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre, Cherkassy, 18009, Ukraine| MI Dnipropetrovsk City Multi-field Clinical Hospital #4 Department of Oncology , Dnipro, 49102, Ukraine|LLC Ukrainian Center of Tomotherapy Tomoclinic , Chemoteraphy Department, Kropyvnytskyi, 25011, Ukraine|National Institute of Cancer Abdominal Oncology Department, Kyiv, 03022, Ukraine|Medical Center n.a. Acad. Spizhenko Syber Clinic Spizhenko Department of Oncology, Kyiv, 08112, Ukraine| Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology LISOD , Kyiv, 08720, Ukraine|Podillia Regional Oncology Centre Chemotherapy Department, Vinnitsya, 21029, Ukraine

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT04737187/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT04737187/SAP_001.pdf

{ "Trifluridine/tipiracil": [ { "intervention_type": "DRUG", "description": "Trifluridine/Tipiracil", "name": "Trifluridine/tipiracil", "synonyms": [ "Trifluridine/tipiracil", "Lonsurf", "Lonsurf", "Trifluridine and Tipiracil", "Lonsurf", "Trifluridine and Tipiracil" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Trifluridine/tipiracil", "generic_names": [ "Trifluridine and Tipiracil", "Trifluridine and Tipiracil" ] } ], "Bevacizumab": [ { "intervention_type": "DRUG", "description": "Bevacizumab", "name": "Bevacizumab", "synonyms": [ "Bevacizumab", "Bevacizumab awwb", "bevacizumab-awwb", "rhuMAb-VEGF", "Zirabev", "Avastin", "Anti-VEGF monoclonal antibody", "Bevacizumab-awwb", "Mvasi", "Anti-VEGF Humanized Monoclonal Antibody" ], "medline_plus_id": "a607001", "generic_names": [ "Bevacizumab" ], "mesh_id": "D000074322", "drugbank_id": "DB00112", "wikipedia_url": "https://en.wikipedia.org/wiki/Bevacizumab" } ] }

NCT00938587

A Study Of PF-04171327 In The Treatment Of The Signs And Symptoms Of Rheumatoid Arthritis

https://clinicaltrials.gov/study/NCT00938587

COMPLETED

This study will investigate the safety and efficacy of an investigational drug, PF-04171327 on the signs and symptoms of rheumatoid arthritis in patients that require glucocorticoids while on background methotrexate. This study will also look at the response of chemical and biological markers in rheumatoid arthritis patients. Lastly, this study will measure the PK (amount of drug in the blood) of methotrexate while patients may be taking PF-04171327.

YES

Rheumatoid Arthritis

DRUG: PF-04171327 10 mg|OTHER: Prednisone Placebo|DRUG: PF-04171327 25 mg|OTHER: Prednisone Placebo|DRUG: Prednisone 5 mg|OTHER: Placebo for PF-04171327|OTHER: Placebo|OTHER: Placebo for PF-04171327

Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 14, DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, CRP (normal range of CRP is less than (<) 10 milligram per liter [mg/L], decrease in the level of CRP indicates reduction in inflammation) and participant global assessment (PGA) of disease activity (participant global assessment of diseases condition scores ranging from 0 [very well condition] to 100 [very poor condition], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: less than equal to (<=) 3.2 implied low disease activity; greater than (>) 3.2 to 5.1 implied moderate to high disease activity., Baseline, Day 14

Change From Baseline in Tender Joints Count at Day 7, 14, 42, Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1., Baseline, Day 7, 14, 42|Change From Baseline in Swollen Joints Count at Day 7, 14 and 42, Number of swollen joints was determined by examination of 28 joints and identifying if swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1., Baseline, Day 7, 14, 42|Change From Baseline in C-Reactive Protein (CRP) at Day 7, 14 and 42, The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is less than (<) 10 mg/L. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement., Baseline, Day 7, 14, 42|Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Day 7 and 14, HAQ-DI assessed the ability of participants to perform task in 8 domains of daily living activities: dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities. Each item was scored on a 4-point scale ranging from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do, higher scores indicate more difficulty. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score range: 0 (no difficulty) to 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities., Baseline, Day 7, 14|Change From Baseline in Participant Assessment of Arthritis Pain at Day 7 and 14, Participant assessment of arthritis pain included assessment of severity of arthritis pain using a 100 millimeter (mm) visual analog scale (VAS). Participants placed a mark on the VAS between 0 mm (no pain) and 100 mm (most severe pain), which corresponded to the magnitude of their pain, higher scores indicate more pain., Baseline, Day 7, 14|Change From Baseline in Participant Global Assessment (PGA) of Arthritis at Day 7 and 14, PGA was a questionnaire where participants answered the following question, Considering all the ways your arthritis affects you, how are you feeling today? The participants response were recorded using a 100 mm visual analog scale placing a mark on the scale, between 0 mm (very well condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis., Baseline, Day 7, 14|Change From Baseline in Physician Global Assessment (PhGA) of Arthritis at Day 7 and 14, PhGA included assessment of severity of arthritis pain where physicians were asked to rate the severity of the participants overall arthritis. The physicians response was recorded using a visual analog scale between 0 mm (very good condition) to 100 mm (very poor condition). Higher scores indicate higher degree of arthritis., Baseline, Day 7, 14|Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) at Day 14, SF-36 is a standardized survey evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Score for each of the 8 aspects are scaled from 0 (worst condition) to 100 (best condition), where higher scores indicate better health status. These 8 domains were also reported as two summary scores: physical component scores and mental component scores. Score range for each of the 2 summary scores = 0 (worst condition) to 100 (best condition), where higher scores represent better health status., Baseline, Day 14 (D14)|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 [CRP]) at Day 7, 14 and 42, DAS28-3 (CRP) was calculated from the swollen joint count and tender joint count using the 28 joints count and CRP (normal range of CRP is <10 mg/L, decrease in the level of CRP indicates reduction in inflammation). Total DAS28-3 (CRP) score range: 0 (least severe) to 9.4 (most severe), higher scores indicate more disease activity., Baseline, Day 7, 14, 42|Change From Baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Day 7, DAS28-4 (CRP) examines progression or improvement of RA. It was assessed from SJC and TJC using the 28 joints count, CRP (normal range of CRP is <10 mg/L, decrease in the level of CRP indicates reduction in inflammation) and PGA of disease activity (participant global assessment of diseases condition scores ranging from 0 [very well condition] to 100 [very poor condition], higher scores indicated greater affectation due to disease activity). Total DAS28-4 (CRP) transformed score range: 0 (least severe) to 10 (most severe), higher scores indicate more severe disease activity. DAS28-4 (CRP) scores: <=3.2 implied low disease activity; >3.2 to 5.1 implied moderate to high disease activity., Baseline, Day 7|Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Day 7 and 14, ACR20 responder: participants who achieved at =20% improvement in tender and swollen 28-joints count, and >=20% improvement in at least 3 of the following 5 measures: 1) participants assessment of arthritis pain (participants self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participants assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation)., Day 7, 14|Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Day 7 and 14, ACR50 responder: participants who achieved at =50% improvement in tender and swollen 28-joints count, and >=50% improvement in at least 3 of the following 5 measures: 1) participants assessment of arthritis pain (participants self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participants assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation)., Day 7, 14|Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Day 7 and 14, ACR70 responder: participants who achieved at =70% improvement in tender and swollen 28-joints count, and >=70% improvement in at least 3 of the following 5 measures: 1) participants assessment of arthritis pain (participants self-assessed severity of arthritis pain, score range from 0[no pain] to 100[most severe pain], higher scores=more pain), 2) PGA of arthritis (participants assessed overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 3) PhGA of arthritis (physician rated severity of participants overall arthritis activity, score range from 0[no arthritis] to 100[extreme arthritis], higher scores=higher degree of arthritis), 4) HAQ-DI (assessment of functional disability, score range from 0[no difficulty] to 3[extreme difficulty], higher scores=more functional limitation) and 5) CRP (assessment of inflammation, normal range of CRP is <10 mg/L, decrease in the level of CRP=reduction in inflammation)., Day 7, 14|Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs), An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 31 days after last dose (Day 45) that were absent before treatment or that worsened relative to pretreatment state., Baseline up to Day 45|Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities, Criteria for laboratory abnormalities: Hematology (hemoglobin, hematocrit <0.8*baseline; platelet count <75 or >700*10^3 per mm^3; leucocytes <2.5 or >17.5*10^3 per mm^3); chemistry (total bilirubin >1.5*upper limit of reference range [ULN]; aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, >3.0*ULN; total protein, albumin <0.8*lower limit of reference range [LLN] or >1.2*ULN; blood urea nitrogen [BUN]/urea, creatinine >1.3*ULN; glucose [fasting] <0.6*LLN or >1.5*ULN; uric acid >1.2*ULN; sodium <0.95*LLN or >1.05*ULN; potassium, calcium <0.9*LLN or >1.1*ULN; albumin, total protein <0.8*LLN or >1.2*ULN; urinalysis (urine white blood cell (WBC) =>6/ high power field (hpf); urine red blood cell (RBC) =>6/hpf). Number of participants with clinically significant change from baseline in laboratory abnormalities identified by investigator were reported., Baseline up to Day 45|Change From Baseline in Body Weight at Day 7 and 14, Baseline, Day 7, 14|Number of Participants With Clinically Significant Vital Signs Abnormalities, Following parameters were analyzed for examination of vital signs: systolic and diastolic blood pressure, heart rate and body temperature. Vital sign measurements were performed with the participant in the seated position. Clinical significance vital sign abnormality was determined by investigator., Baseline up to Day 45|Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities, Clinically significant ECG findings included PR interval >=300 milliseconds (msec) or >=25% increase from baseline (if baseline PR interval >200 msec) or >=50% increase (if baseline PR interval less than or equal to [<=] 200 msec); QRS interval >=200 msec or >=25% increase from baseline (if baseline PR interval >100 msec) or >=50% increase (if baseline PR interval <= 100 msec); QT interval >=500 msec, corrected QT interval >=500 msec., Baseline up to Day 45|Plasma Concentration of PF-00251802 Versus Time Summary on Day 7 and Day 14, Plasma concentration of PF-00251802 versus time summary, a metabolite of PF-04171327 was reported in this outcome measure., 0, 1, 2, 3 and 4 hours post-dose on Day 7, 14|Ratio of Apparent Oral Clearance on Day 1 to Day 14 of Methotrexate, Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. Methotrexate was used as a background therapy by participants., Pre-dose (0 hour), 1, 2, 3 and 4 hours post-dose|Change From Baseline in Lymphocyte Counts at Day 1, 7 and 14, Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14|Change From Baseline in Neutrophil Counts at Day 1, 7 and 14, Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14|Change From Baseline in Eosinophil Counts at Day 1, 7 and 14, Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14|Change From Baseline in Osteocalcin Level at Day 1, 7 and 14, Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14|Change From Baseline in Plasma Cortisol Level at Day 1, 7 and 14, Baseline; 1, 2, 3 and 4 hours post-dose on Day 1; 0, 1, 2, 3 and 4 hours post-dose on Day 7 and 14|Change From Baseline in Ratio of Urinary N-terminal Telopeptide of Type 1 Collagen (uNTX-I) Level to Urinary Creatinine (uCr) Level at Day 7 and 14, Unit of ratio of urinary N-terminal telopeptide of type 1 collagen (uNTX-I) level to urinary creatinine (uCr) level was nanomoles bone collagen equivalents (nmol bce) per millimole creatinine (mmol cr)., Baseline, Day 7 and 14|Change From Baseline in Adiponectin Level at Day 7 and 14, Baseline, Day 7 and 14

Pfizer

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

A9391005|2009-013223-37

2009-10-07

2010-07-29

2010-07-29

2009-07-14

2023-11-22

2023-11-22

Anniston Medical Clinic, PC, Anniston, Alabama, 36207, United States|Pinnacle Research Group, LLC, Anniston, Alabama, 36207, United States|Allergy, Asthma, Arthritis and Lung, Daytona Beach, Florida, 32114, United States|Elite Research Institute, Miami, Florida, 33169, United States|Millennium Research, Ormond Beach, Florida, 32174, United States|Florida Medical Clinic, PA, Zephyrhills, Florida, 33542, United States|The Arthritis Center, Springfield, Illinois, 62704, United States|Premier Imaging Center, Bingham Farms, Michigan, 48025, United States|Quest Research Institute, Bingham Farms, Michigan, 48025, United States|Altoona Center for Clinical Research, Duncansville, Pennsylvania, 16635, United States|MEDIPONT Plus, s.r.o., Ceske Budejovice, 370 01, Czechia|ARTMEDI UPD s r.o., Hostivice, 253 01, Czechia|DC Mediscan, Praha 11 - Chodov, 148 00, Czechia|Revmatologicka ambulance, Praha 4, 140 00, Czechia|Fakultni Thomayerova nemocnice s poliklinikou, Praha 4, 140 59, Czechia|Centre for Assessment and Treatment of Rheumatic Diseases, Department of Medicine and Geriatrics, New Territories, Hong Kong|Dr. Rethy Pal Korhaz es RendelointezetReumatologia, Bekescsaba, 5600, Hungary|Synexus Magyarorszag Kft., Budapest, H-1036, Hungary|Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, Debrecen, 4032, Hungary|MAV Korhaz es Rendelointezet, Szolnok, H-5000, Hungary|Severance Hospital, Yonsei University College of Medicine, Rheumatology, Internal Medicine, Seoul, 120-752, Korea, Republic of|Moscow SHI City Clinical Hospital #4, Department of Therapy of Moscow Faculty, Moscow, 115093, Russian Federation|Institution of Russian Academy of Medical Sciences Research Institute of Rheumatology RAMS, Moscow, 115522, Russian Federation|SI Saint-Petersburg SRI for Emergency Care named after I.I. Dzhanelidze, Saint-Petersburg, 192242, Russian Federation|Regional State Institution of Healthcare Smolensk Regional Clinical Hospital, Smolensk, 214018, Russian Federation|Institute of Rheumatology, Belgrade, 11000, Serbia|Institute for Rheumatic and Cardiovascular Disease Niska Banja, Niska Banja, 18205, Serbia|Changi General Hospital, Singapore, 529889, Singapore|Narodny ustav reumatickych chorob, Klinicke oddelenie, Piestany, 921 12, Slovakia|Nestatna reumatologicka ambulancia, MUDr. Pavol Polak, s.r.o., Zilina, 010 01, Slovakia|Hospital Nuestra Señora de La Esperanza, Santiago de Compostela, A Coruña, 15705, Spain|Hospital de Cruces, Baracaldo, Bilbao, 48903, Spain|Hospital de Basurto, Bilbao, Vizcaya, 48013, Spain|Hospital Universitario Virgen Macarena, Sevilla, 41009, Spain|Taichung Veterans General Hospital, Taichung, 407, Taiwan|Ankara University School fo Medicine, Ankara, 06100, Turkey|Chair of Cardiology & Functional Diagnostic, Kharkiv, 61176, Ukraine|State Institution Institute of Gerontology of AMS of Ukraine , Kyiv, 04114, Ukraine|State Institution Institute of Gerontology of AMS of Ukraine, Kyiv, 04114, Ukraine|Municipal City Clinical Hospital #4, Department of Rheumatology, Lviv, 79011, Ukraine|Vinnitsa Regional Clinical Hospital n.a. Pirogov, Vinnitsa, 21018, Ukraine

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NCT05604287

Safety, Tolerability, and Pharmacokinetics of ID119031166M With the Exploration of Pharmacodynamic Effects

https://clinicaltrials.gov/study/NCT05604287

RECRUITING

This study will evaluate safety, tolerability, and Pharmacokinetics (PK) of ID119031166M with the Exploration of Pharmacodynamic (PD) effects in Healthy Participants.

NO

Healthy Participants

DRUG: ID119031166M|DRUG: Placebo

Number of participants with Serious Adverse Events (SAEs) and Adverse Events (AEs), To evaluate the safety and tolerability of single and multiple ascending doses of ID119031166M in healthy participants., From Screening (Day -28 to -3) until termination (approximately Day 8 for SAD and Day 22 for MAD)

Maximum plasma concentration determined directly from the concentration- time profile (Cmax), To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants., Day 1-4 for SAD and Day 1-17 for MAD|Time of maximum plasma concentration determined directly from the concentration-time profile (Tmax), To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants. To explore food effect on PK of ID119031166M after a single-dose administration in healthy participants., Day 1-4 for SAD and Day 1-17 for MAD|Area under curve from pre-dose (time 0) to the time of the last quantifiable concentration (tlast) (AUC0-last), To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants., Day 1-4 for SAD and Day 1-17 for MAD|Dose-normalized Cmax, To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants., Day 1-4 for SAD and Day 1-17 for MAD|Dose-normalized AUC from pre-dose (time 0) extrapolated to 24 hours (AUC0-24), To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants., Day 1-4 for SAD and Day 1-17 for MAD|Dose-normalized AUC0-last, To assess the PK of ID119031166M when given at single and multiple ascending doses in healthy participants., Day 1-4 for SAD and Day 1-17 for MAD

IlDong Pharmaceutical Co Ltd

Parexel|YUNOVIA CO.,LTD.

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT

ID119031166M-NASH-101

2022-10-10

2024-06-30

2024-06-30

2022-11-03

2024-04-18

California Clinical trials medical group/PAREXEL, Glendale, California, 91206, United States

{ "ID119031166M": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT06038487

Immediate Versus Delayed Loading of Maxillary Overdenture Implants

https://clinicaltrials.gov/study/NCT06038487

RECRUITING

The purpose of the study is to evaluate the radiographic, clinical and patient-centered outcomes of implant-retained immediately-loaded maxillary complete dentures in comparison to delayed loading approach by primarily evaluating radiographic bone loss of dental implants placed in the maxilla over 36 months

NO

Implant Complication

PROCEDURE: Immediate loading of maxillary implant overdenture|PROCEDURE: Delayed loading of maxillary implant overdenture

Radiographic bone level of changes of implants, The primary objective of this study is to evaluate radiographically at 6, 12, 24 and 36 months post-loading the performance of the BLX Roxolid™ implants placed using a flapless guided surgery and immediately loaded with a maxillary overdenture versus delayed loading 3 months after surgical placement. The outcome will be evaluated using peri-implant, radiographic bone level changes measure in milimeters from standardized radiographs from baseline to 6, 12, 24 and 36 months post implant placement., 36 months

Pocket Depth of the peri-implant mucosa, Will be recorded as a whole number in milimeters at 6 sites per implant, 36 months|Bleeding on probing of the peri-implant mucosa, Will be recorded as a absence or presence of bleeding on probing at 6 sites per implant, 36 months|Implant survival, Implant survival at 6, 12, 24 and 36 months will be recorded as implant present or implant lost, 36 months|Complications, The nature of surgical and prosthetic complications. For example, fracture of denture or loosening of implant abutment., 36 months|Patient-centered outcomes, Patient-centered outcomes according to Oral Health Impact Profile-14 (OHIP 14). The subjects will answer questions about their dentures and the potential problems they encounter and will have answer options of very often, fairly often, occasionally, hardly ever, never, or dont know. Never is considered the best outcome, 36 months

Case Western Reserve University

Institut Straumann AG

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT

STUDY20221174

2023-02-01

2025-02-01

2028-02-01

2023-09-14

2023-10-27

Case Western Reserve University Department of Periodontics, Cleveland, Ohio, 44106, United States

Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/87/NCT06038487/ICF_000.pdf

{ "Immediate loading of maxillary implant overdenture": [ { "intervention_type": "PROCEDURE" } ], "Delayed loading of maxillary implant overdenture": [ { "intervention_type": "PROCEDURE" } ] }

NCT03678987

Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis

https://clinicaltrials.gov/study/NCT03678987

MMFSSC

COMPLETED

Drug of investigation: Mycophenolate mofetil (MMF), given orally as a tablet twice daily. Dosage of drug: This study recruits patients who have been prescribed a steady dose of MMF in the range between 1000 and 3000 mg daily by their physician. Design: This is an open-label PK study. Disease studied: Systemic sclerosis (SSC, scleroderma). Variables assessed: Estimated AUC0-12 for MMF. Gastrointestinal manifestations of SSc. Concomitant medication. Study population: Inclusion criteria: Diagnosis of SSC fulfilling the 2013 classification criteria for this disease. Participant should have been prescribed a stable dose of MMF tablets, taken twice daily, for at least 3 months prior to the study. Exclusion criteria: Failure to comply with study protocol. Limited access to repeated venous puncture. Recipient of organ transplant. Pulmonary arterial hypertension. Number of participants: The study aims at the inclusion of 35 subjects. Primary objective: To investigate the PK of orally ingested MMF in SSC. Secondary objectives: 1. To investigate how SSC manifested in the gastrointestinal (GI) tract may alter the PK of MMF. 2. To investigate how the PK of MMF in SSc is altered by medications often used in SSC, i.e. proton pump inhibitors (PPI), NSAID and calcium channel blockers.

NO

Systemic Sclerosis|Gastrointestinal Complication

DIAGNOSTIC_TEST: P-MPA concentration|DRUG: mycophenolic acid

Individual plasma concentrations of mycophenolic acid, By 4 measurements of P-MPA during a 6 hour time period we will estimate the individual drug exposition expressed as Area Under the Curve (AUC) 0-12 for this medicine and calculated as suggested by Abd Rahman 2014 (reference 3)., 1 day

Correlation between F-calprotectin and the AUC of P-MPA, To investigate how gastrointestinal inflammation as measured by F-calprotectin correlate with the AUC of P-MPA, 1 day|Correlation between the USCLA SCTC GIT-2.0 questionnaire and the AUC of P-MPA, To investigate how the gastrointestinal manifestations of SSc, assessed by a SSc-specific questionnaire, correlate with the AUC of P-MPA, 1 day|Correlation between the Malnutrition Universal Screening Tool (MUST) and the AUC of P-MPA, To investigate if malnutrition, assessed by the MUST, correlate with the AUC of P-MPA, 1 day|Correlation between the precense of dysbiosis, as defined by the GA-MAP Dysbiosis Test and the AUC of P-MPA, To investigate if intestinal dysbiosis, assessed by the a validated test available through Genetic Analysis, Oslo Norway, is associated with the AUC of P-MPA, 1 day|Association between the AUC of P-MPA and the concomitant medication with a) NSAID, b) proton-pump inhibitors and c) Ca-channel blockers, To compare the AUC of P-MPA in patients with and without the above mentionened concomitant medication, 1 day

Region Skane

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2018-002105-54

2018-09-13

2020-01-01

2020-02-01

2018-09-20

2020-03-13

Reumatologi SUS Lund, Region Skåne, Lund, 221 85, Sweden

{ "P-MPA concentration": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Mycophenolate": [ { "intervention_type": "DRUG", "description": "mycophenolic acid", "name": "Mycophenolate", "synonyms": [ "Myfortic", "Mycophenolic acid", "Acidum mycophenolicum", "Acido micofenolico", "CellCept", "Mycophenolate", "Micofenolico acido", "(e)-6-(4-Hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoic acid", "Mycophenols\u00e4ure", "Acide mycophenolique" ], "medline_plus_id": "a601081", "generic_names": [ "Mycophenolic acid", "Mycophenolate" ], "drugbank_id": "DB01024", "wikipedia_url": "https://en.wikipedia.org/wiki/Mycophenolic%20acid" } ] }

NCT05159687

Study of Atomoxetine in the Prevention of Vasovagal Syncope

https://clinicaltrials.gov/study/NCT05159687

POST7

RECRUITING

Project rationale: Vasovagal syncope (VVS) affects up to 50% of people, and recurrent syncope markedly reduces quality of life. We recently reported that it is frequently associated with injury and not surprisingly with clinical anxiety. Although conservative measures help many patients there remain many who require more care. CIHR-funded studies have shown that fludrocortisone and midodrine are effective but cannot be used in patients with contraindications such as hypertension and heart failure. Pacemakers are partially effective in older patients, but this is established only in the small minority with proven asystole. There remains a need for a simple, once-daily medication with few contraindications that can be used as first-line therapy for most patients with recurrent vasovagal syncope. Preliminary Studies: Norepinephrine transport (NET) inhibitors show promise as a novel treatment. Three (reboxetine, sibutramine, and atomoxetine) all prevent vasovagal syncope in healthy subjects and vasovagal syncope patients on tilt tests. Atomoxetine, approved to treat attention deficit disorder, is a highly selective NET inhibitor. We reported a proof-of-principle, randomized, placebo-controlled trial of the efficacy of atomoxetine to prevent vasovagal syncope on tilt table tests. Patients underwent tilt testing after receiving either atomoxetine 40 mg or placebo. Fewer VVS patients fainted with atomoxetine than placebo (10/29 vs. 19/27; odds ratio 0.22, p < 0.01). Our meta-analysis of the effects of NET inhibition on the vasovagal reflex induced by tilt tests was highly positive. A pre-post study showed that sibutramine reduced syncope frequency in highly symptomatic and drug-refractory patients. A similar pre-post study showed that atomoxetine also reduces syncope frequency about 85% in patients with frequent and drug-intolerant or drug-resistant vasovagal syncope. Therefore,NET inhibition by atomoxetine merits assessment based on positive proof-of-principle studies, an apparent class effect, and two open-label pre-post studies. These results provide the rationale for a formal randomized, placebo-controlled, crossover trial of atomoxetine in moderate-to-high risk patients with VVS. Hypothesis: We will test the hypothesis that oral atomoxetine prevents syncope in patients with recurrent VVS. The Study: Patients will be included based on a positive Calgary Syncope Symptom Score and a history of at least 2 faints in the previous year. Eligible patients will be randomized to atomoxetine 40 mg po twice daily or matching placebo in a randomized, placebo-controlled, parallel design, double-blind, crossover trial. Each arm will last 6 months with a 1-week washout period. The primary outcome measure will be the proportion of patients with at least 1 syncope recurrence. The study will be powered to detect a beneficial odds ratio of 0.5, selected on the basis of the control outcome rates in 2 similarly designed, previous studies and international expert requirements for effect size. A sample size of 180 subjects will provide 85% power of detecting a difference between the arms at p<0.05. We will assess the effects of atomoxetine on quality of life, anxiety, injury, and the cost-effectiveness of atomoxetine treatment, and the effects of genetic factors on outcomes. Substudies : The quality of life scales will be the SF-36 and the Euroqol EQ5D, which will also be used as the health utility index for the economic studies. The depression and anxiety scales will be the Hospital and Anxiety Depression Score (HADS) and the General Anxiety Disorder - 7 Score (GAD-7). Clinical anxiety is highly prevalent in patients with recurrent syncope. Injury will be self-reported using our published definitions. The health economic substudy will be from the health system perspective and will use Alberta administrative data. DNA will be collected from spit acquired in the Oragene saliva self-collection kits, and an initial candidate gene study might include alleles of CYP2D6, COMT, the serotonin (SLC6A4) and norepinephrine (SLC6A2) reuptake transporters, and the 5HT1A and 5HT3 receptors. Summary: Adults who faint recurrently are highly symptomatic. There are no therapies suitable for most patients have withstood the test of randomized clinical trials. If successful, atomoxetine will reduce syncope and improve quality of life.

NO

Vasovagal Syncope

DRUG: Atomoxetine Hydrochloride|DRUG: Placebo

The primary outcome measure will be the proportion of patients having at least one syncope recurrence., one syncope recurrence, Within 12 months period of the study

Hospital Anxiety and Depression Scale (HADS), The total score is out of 42, (21 per subscale). Scores are derived by summing responses for each of the two subscales or for the scale as a whole Higher scores indicate greater levels of anxiety or depression. The total HADS score may be regarded as a global measure of psychological distress, every 6 months of the study up to 12 months|Generalized Anxiety Disorder score, The GAD-7 is useful in primary care and mental health settings as a screening tool and symptom severity measure for the four most common anxiety disorders (Generalized Anxiety Disorder, Panic Disorder, Social Phobia and PostTraumatic Stress Disorder). It is 70-90% sensitive and 80-90% specific across disorders / cutoffs (see Evidence section for more). Higher GAD-7 scores correlate with disability and functional impairment (in measures such as work productivity and health care utilization), every 6 months of the study up to 12 months|EQ-5D-3L, The EQ-5D-3L classification system consists of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with three levels: no problems 1 , moderate problems 2 , and severe problems 3 . Each health state is described as a vector of these five dimensions. With 3 levels for each dimension, the EQ-5D-3L describes 243 distinct health states, with 11111 being the best health state (full health), and 33333 the worst health state. In addition to the classification system, each of the instruments also includes a visual analogue scale (EQ VAS). The EQ VAS records the respondents self-rated health on a visual analogue scale from 0 to 100, whereby 0 indicates the worst health you can imagine, and 100 the best health you can imagine. This information can be used as a quantitative measure of health as judged by the individual respondents., every 6 months of the study up to 12 months|Rand 36 Scale, The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table, every 6 months of the study up to 12 months|ISQL form, The ISQL is a brief valid measure of the impact of syncope on quality of life. It measures impairment, fear, depression, and physical limitations, and correlates with recent syncope frequency., every 6 months of the study up to 12 months|Medical Utilization form, Cost, and cost-effectiveness, every 3 months of the study up to 12 months

University of Calgary

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT

POST 7

2022-06-01

2026-09

2027-09

2021-12-16

2024-05-09

University of Calgary, Calgary, Alberta, T2N 1N4, Canada

{ "Atomoxetine": [ { "intervention_type": "DRUG", "description": "Atomoxetine Hydrochloride", "name": "Atomoxetine", "synonyms": [ "Tomoxetine", "Tomoxetinum", "Atomoxetine", "(-)-Tomoxetine", "Atomoxetina", "Tomoxetina", "Strattera" ], "medline_plus_id": "a603013", "generic_names": [ "Atomoxetine" ], "drugbank_id": "DB00289" } ], "Mianserin": [ { "intervention_type": "DRUG", "description": "Atomoxetine Hydrochloride", "name": "Mianserin", "synonyms": [ "Mianserin", "Mianserine", "Mians\u00e9rine", "Mianserina", "Hydrochloride", "Monohydrochloride, Mianserin", "Mianserin Monohydrochloride", "Mianserinum", "Tolvon", "Lerivon", "1,2,3,4,10,14b-Hexahydro-2-methyldibenzo(c,f)pyrazino(1,2-a)azepine", "Mianseryna", "Org GB 94", "Hydrochloride, Mianserin", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum" ], "mesh_id": "D018687", "generic_names": [ "Mianserin", "Procaterol", "Procaterol" ], "drugbank_id": "DB06148" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT02229487

The Relationship Between Sleep and Glucose Tolerance in Prediabetes: the Role of GLP-1 in Short Sleepers

https://clinicaltrials.gov/study/NCT02229487

Sleep GLP-1

COMPLETED

Hypothesis 1. Prediabetes patients who have insufficient sleep will have worse glucose tolerance than those with normal sleep duration. 2. Prediabetes patients with short sleep will have a delayed or reduced GLP-1 response to a standardized meal

YES

Prediabetes

OTHER: Oral glucose tolerance

GLP-1 Levels in Response to Oral Glucose Tolerance Test, Prediabetes patients with and without short sleep will undergo an oral glucose tolerance test with measurement of GLP-1 levels, 2 weeks

Ramathibodi Hospital

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC

08-57-16

2014-10

2017-03

2017-03-31

2014-09-01

2017-08-14

2017-10-10

Faculty of Medicine Ramathibodi Hospital, Bangkok, Thailand

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT02229487/Prot_SAP_000.pdf

{ "Oral glucose tolerance": [ { "intervention_type": "OTHER" } ] }

NCT02441387

Predictors of the Outcome of Late Life Depression

https://clinicaltrials.gov/study/NCT02441387

UNKNOWN

Predictors of response to pharmacological treatment of major depressive disorder will be investigated. One hundred and twenty patients will be included in a naturalistic clinical trial. Psychopathology, personality traits, cognitive performance, brain structural changes and genetic polymorphisms will be evaluated. Patients will be followed for 18 months with a pharmacological treatment algorithm and will be evaluated monthly until 6th month and every 3 months, up to 18 months. Psychoeducation will be offered to patients who did not remit until 3 months of pharmacological tretment.

NO

Major Depression

DRUG: Antidepressant|OTHER: Psychoeducation|OTHER: Treatment as usual (only pharmacological treatment).

Change from Baseline Montgomery-Asberg Depression Scale (MADRS) below 8 during the initial 12 weeks of the study and remained below 8 until 18 months, The investigators will consider patients remitted when their MADRS scale score decreased below 8 during the initial 12 weeks of the study and remained below 8 until 24 weeks. All patients whose MADRS scores decreased to 8 but rose above 8 during the study or whose MADRS score remained at 8 or above throughout the study were considered not remitted, 18 months

Change from baseline Clinical Global Impression (CGI) up to 18 months, It will be applied on 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th, 15th, and 18th months of follow-up. On the 6th, 12th, and 18th months, the Mini Mental State Examination (MMSE), the Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG)and the Bayer Activities of Daily Living Scale (B-ADL) will be applied., 18 months|Change from baseline Hamilton-D Scale (HAM-D) up to 18 months, It will be applied on 1st, 2nd, 3rd, 4th, 5th, 6th, 9th, 12th, 15th, and 18th months of follow-up. On the 6th, 12th, and 18th months, MMSE, the CAMCOG and the B-ADL will be applied., 18 months|Change from baseline Mini Mental State Examination (MMSE) up to 18 months, It will be applied on 1st, 12th, and 18th months of follow-up. On the 6th, 12th, and 18th months, MMSE, the CAMCOG and the B-ADL will be applied., 18 months|Change from baseline Cognitive and self-contained part of the Cambridge Examination for Mental Disorders of the Elderly (CAMCOG) up to 18 months, It will be applied on 1st, 12th, and 18th months of follow-up., 18 months|Change from baseline Bayer Activities of Daily Living Scale (B-ADL) up to 18 months, It will be applied on 1st, 12th, and 18th months of follow-up., 18 months

University of Sao Paulo General Hospital

Fundação de Amparo à Pesquisa do Estado de São Paulo

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

PREDLLD10446

2015-04

2018-03

2019-07

2015-05-12

2018-05-24

University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry, São Paulo, 05403-010, Brazil

{ "Antidepressant": [ { "intervention_type": "DRUG" } ], "Psychoeducation": [ { "intervention_type": "OTHER" } ], "Treatment as usual (only pharmacological treatment).": [ { "intervention_type": "OTHER" } ] }

NCT04538287

AtaCor Subcostal Temporary Extravascular Pacing III Study

https://clinicaltrials.gov/study/NCT04538287

STEP III

COMPLETED

Third in-human study for the AtaCor Extravascular (EV) Temporary Pacing Lead System to collect initial safety and performance data for the latest AtaCor System. The objective of the study is to generate safety and performance data of the latest AtaCor EV Temporary Pacing Lead System 1) to support the development a future pivotal study with an indication limited to a maximum of 7 days, and 2) to obtain early clinical data for future research related to longer-term use.

NO

Conduction Defect

DEVICE: AtaCor StealthTrac Lead

Safety - Freedom from Adverse Device Effects, Freedom from Adverse Device Effects (ADE), Lead removal (up to 14 Days)|Performance - Pacing Capture Threshold, Summary statistics for pacing capture threshold for each StealthTrac Lead model from insertion through removal, Lead removal (up to 14 Days)|Performance - Pacing Impedance, Summary statistics for pacing impedance for each StealthTrac Lead model from insertion through removal for each StealthTrac Lead model from insertion through removal, Lead removal (up to 14 Days)|Performance - Sensed R-wave Amplitude, Summary statistics for sensed R-wave amplitude for each StealthTrac Lead model from insertion through removal, Lead removal (up to 14 Days)

AtaCor Medical, Inc.

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE

DOC-10092

2020-10-03

2022-01-25

2022-05-11

2020-09-04

2022-07-07

Na Homolce Hospital, Prague, Czechia|Christchurch Hospital, Christchurch, New Zealand|Wellington Regional Hospital, Wellington, New Zealand|Sanatorio Italiano, Asunción, Paraguay

{ "AtaCor StealthTrac Lead": [ { "intervention_type": "DEVICE" } ] }

NCT01173887

Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15

https://clinicaltrials.gov/study/NCT01173887

COMPLETED

This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also determined.

NO

Adult T-cell Leukemia-Lymphoma

DRUG: VCAP/AMP/VECP(mLSG15)|BIOLOGICAL: KW-0761

Complete response rate in the best overall response assessment for antitumor effect, After cycle 2 and cycle 4