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NCT01342887

Cyclosporine, Pravastatin Sodium, Etoposide, and Mitoxantrone Hydrochloride in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia

https://clinicaltrials.gov/study/NCT01342887

TERMINATED

This phase I/II trial studies the side effects and best dose of etoposide and mitoxantrone hydrochloride when given together with cyclosporine and pravastatin sodium and to see how well they work in treating patients with relapsed or refractory acute myeloid leukemia (AML). Cyclosporine may inhibit efflux of cancer drugs out of cancer cells and may thereby improve chemotherapy treatment for AML. Pravastatin sodium may stop the growth of cancer cells by blocking some of the nutrients needed for cell growth. Drugs used in chemotherapy, such as etoposide and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving cyclosporine together with pravastatin sodium, etoposide, and mitoxantrone hydrochloride may kill more cancer cells

YES

Adult Acute Megakaryoblastic Leukemia (M7)|Adult Acute Minimally Differentiated Myeloid Leukemia (M0)|Adult Acute Monoblastic Leukemia (M5a)|Adult Acute Monocytic Leukemia (M5b)|Adult Acute Myeloblastic Leukemia With Maturation (M2)|Adult Acute Myeloblastic Leukemia Without Maturation (M1)|Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities|Adult Acute Myeloid Leukemia With Del(5q)|Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)|Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)|Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)|Adult Acute Myelomonocytic Leukemia (M4)|Adult Erythroleukemia (M6a)|Adult Pure Erythroid Leukemia (M6b)|Recurrent Adult Acute Myeloid Leukemia

DRUG: cyclosporine|DRUG: pravastatin sodium|DRUG: mitoxantrone hydrochloride|DRUG: etoposide|PROCEDURE: bone marrow aspiration

Maximum Tolerated Doses Mitoxantrone Hydrochloride and Etoposide When Combined With Cyclosporine and Pravastatin Sodium, Determine the doses of mitoxantrone and etoposide that, when combined with CSA and pravastatin, meet minimum standards for both efficacy and toxicity and have the highest efficacy rate among several mitoxantrone and etoposide doses. Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0., After completion of first 2 courses, up to 22 weeks

CR/CRi, Describe the disease-free survival of patients that achieve Complete Remission (CR)/CR with inadequate recovery of peripheral blood cell counts (CRi). Categorized according to criteria recommended by an International Working Group., After completion of first 2 courses, up to 22 weeks|Disease-free Survival of Patients That Achieve CR/CRi, Describe the disease-free survival of patients that achieve CR/CRi., Up to 4.5 years|Frequency and Severity of Regimen-associated Toxicities, Estimate the frequency and severity of regimen-associated toxicities, along with 28-day mortality after start of study treatment, At 28 days

Fred Hutchinson Cancer Center

National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

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

2409.00|NCI-2011-00657

2011-04

2012-03

2012-03

2011-04-27

2017-07-02

2017-07-02

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States

{ "Cyclosporine": [ { "intervention_type": "DRUG", "description": "cyclosporine", "name": "Cyclosporine", "synonyms": [ "Cyclosporine", "CsA-Neoral", "Ciclosporine", "CyA NOF", "Ciclosporina", "Sandimmune", "Ciclosporin", "Cequa", "OL 27 400", "CsA Neoral", "CsANeoral", "OL 27-400", "Cyclosporin", "Cyclosporin A", "Gengraf", "Sandimmun", "OL 27400", "CsA", "CyA-NOF", "Ciclosporinum", "Restasis", "Cyclosporine A", "Sandimmun Neoral", "CyA", "Neoral" ], "medline_plus_id": "a604009", "generic_names": [ "Cyclosporine" ], "mesh_id": "D065095", "drugbank_id": "DB00091", "wikipedia_url": "https://en.wikipedia.org/wiki/Ciclosporin" } ], "Pravastatin": [ { "intervention_type": "DRUG", "description": "pravastatin sodium", "name": "Pravastatin", "synonyms": [ "Nu-Pravastatin", "Liplat", "SQ31,000", "RMS431", "Pravastatin acid", "SQ 31,000", "Lipostat", "Pravastatin, (6 beta)-Isomer", "CS 514", "RMS 431", "RMS-431", "Apo-Pravastatin", "Pravastatin Monosodium Salt, (6 beta)-Isomer", "Pravachol", "SQ-31,000", "Lin Pravastatin", "Pravastatin tert Octylamine Salt", "SQ31000", "Prareduct", "CS-514", "Mevalotin", "Pravastatin", "Nu Pravastatin", "Bristacol", "Lipemol", "Apo Pravastatin", "Pravacol", "Vasten", "Pravastatine", "Sodium Salt, Pravastatin", "(+)-(3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-{[(S)-2-methylbutyryl]oxy}-1,2,6,7,8,8a-hexahydro-1-naphthyl]heptanoic acid", "Pravastatin Sodium Salt", "Elisor", "SQ 31000", "Pravastatin Sodium", "Pravasin", "Pravastatin tert-Octylamine Salt", "Pravastatina", "CS514", "SQ-31000", "Pravastatinum", "Selektine", "Lin-Pravastatin", "Eptastatin" ], "medline_plus_id": "a692025", "generic_names": [ "Pravastatin" ], "nhs_url": "https://www.nhs.uk/medicines/pravastatin", "mesh_id": "D019161", "drugbank_id": "DB00175", "wikipedia_url": "https://en.wikipedia.org/wiki/Pravastatin" } ], "Mitoxantrone": [ { "intervention_type": "DRUG", "description": "mitoxantrone hydrochloride", "name": "Mitoxantrone", "synonyms": [ "Mitozantrone", "NSC 301739", "Novantrone", "Mitoxantrone Hydrochloride", "NSC299195", "NSC-301739", "CL232325", "Acetate, Mitoxantrone", "Mitoxantrona", "DHAQ", "Hydrochloride, Mitoxantrone", "1,4-Bis(2-(2-hydroxyethylamino)ethyl)amino)-5,8-dihydroxyanthraquinone", "Onkotrone", "Novantron", "NSC-301739D", "NSC 299195", "Ralenova", "NSC 301739D", "NSC287836", "Mitoxantronum", "Mitoxantrone", "CL-232325", "NSC-287836", "NSC 279836", "NSC279836", "Mitroxone", "NSC301739", "Mitoxantrone Acetate", "NSC-279836", "DHAD", "NSC-299195", "NSC301739D", "NSC 287836", "CL 232325", "Pralifan" ], "medline_plus_id": "a608019", "generic_names": [ "Mitoxantrone" ], "mesh_id": "D059005", "drugbank_id": "DB01204" } ], "Etoposide": [ { "intervention_type": "DRUG", "description": "etoposide", "name": "Etoposide", "synonyms": [ "NSC141540", "Etomedac", "Eto-GRY", "4-demethylepipodophyllotoxin \u03b2-D-ethylideneglucoside", "VP 16213", "NSC 141540", "NSC-141540", "Etoposide, (5a alpha)-Isomer", "Exitop", "Eto GRY", "VP 16 213", "VP16", "Etoposide", "trans-Etoposide", "Etoposide, alpha-D-Glucopyranosyl Isomer", "Toposar", "VP 16-213", "V\u00e9p\u00e9side Sandoz", "V\u00e9p\u00e9side-Sandoz", "Etoposide Teva", "Etoposido Ferrer Farma", "Etopophos", "Vepesid", "(\u2212)-etoposide", "4'-Demethylepipodophyllotoxin 9-(4,6-O-(R)-ethylidene-beta-D-glucopyranoside)", "Celltop", "VP-16", "9-((4,6-O-Ethylidine-beta-D-glucopyranosyl)oxy)-5,8,8a,9-tetrahydro-5-(4-hydroxy-3,4-dimethyloxyphenyl)furo(3',4'':6,7)naptho-(2,3-d)-1,3-dioxol-6(5aH)-one", "alpha-D-Glucopyranosyl Isomer Etoposide", "Riboposid", "Etoposide, (5S)-Isomer", "Eposin", "Etoposide, (5a alpha,9 alpha)-Isomer", "Eposide", "Etoposide Pierre Fabre", "Onkoposid", "Lastet", "Etoposidum", "Etoposido", "VP 16", "Etopos", "Teva, Etoposide", "Demethyl Epipodophyllotoxin Ethylidine Glucoside", "Etoposide, alpha D Glucopyranosyl Isomer" ], "medline_plus_id": "a697011", "generic_names": [ "Etoposide" ], "mesh_id": "D059005", "drugbank_id": "DB00773" } ], "bone marrow aspiration": [ { "intervention_type": "PROCEDURE" } ] }

NCT02238587

The Effect of Ganoderma on Patients With Head-and-neck Cancer

https://clinicaltrials.gov/study/NCT02238587

UNKNOWN

To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)

NO

Head-and-neck Cancer

OTHER: Control group|DIETARY_SUPPLEMENT: Ganoderma Spores Powder Capsules

Immune modulation such as tumor necrosis factors-α or interleukin-6, Subjects will be assigned to receive placebo/Ganoderma or Ganoderma Spores Powder Capsules twice a day for 12 weeks. Peripheral blood and saliva will be collected at 3 different times: (1)baseline data: before oral intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention., Change from baseline in cytokines at 6 months

Life quality, Health and life quality will assessed by Quality of Life Questionnaire at three different times: (1)baseline data: before intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention., Change from baseline in life quality at 6 months

Chang Bing Show Chwan Memorial Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

1020304

2014-06

2015-05

2015-05

2014-09-12

2014-09-12

Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital, Changhua County, Taiwan

{ "Control group": [ { "intervention_type": "OTHER" } ], "Ganoderma Spores Powder Capsules": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT02568787

The Effect of an RBAC Supplement (BRM4) on NAFLD

https://clinicaltrials.gov/study/NCT02568787

COMPLETED

The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This nutritional supplement is made from a water soluble extract of rice bran that has been partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom.

NO

Non-Alcoholic Fatty Liver Disease

DIETARY_SUPPLEMENT: rice bran arabinoxylan compound (RBAC)|DIETARY_SUPPLEMENT: Placebo

Change from baseline in liver function test, Liver function tests as defined by serum ALT, AST and ALP, Baseline, 45 days and 90 days|Change from baseline in metabolic markers, Metabolic markers as defined by lipid profile, Baseline,45 days and 90 days|Change from baseline in immunological markers, Immunological markers as defined by TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF RI, IFN-γ, IL-12, IL-2, IL-15, IL-8, TNF RII, IL-4, IL-5, IL-17, IL-23, IL-10, IL-13, and IL-18., Baseline,45 days and, 3 months

Change from baseline in systolic blood pressure, Systolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis., Baseline,45 days and 3 months|Change from baseline in Diastolic blood pressure, Diastolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis., 45 days and 90 days|Pulse, Pulse will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis., Baseline,45 days and 3 months|Change from Baseline in Quality of Life, The SF-36v2™ Health Survey (15) provides psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure that does not target a specific age, disease, or treatment group., Baseline,45 days and 3 months

University of Miami

Daiwa Health Development

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

20150512

2016-05

2017-06-10

2017-06-10

2015-10-06

2017-06-14

University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences, Miami, Florida, 33136-2107, United States

{ "rice bran arabinoxylan compound (RBAC)": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Placebo": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT03269487

PERFECTED WP2: Implementing Optimised Hospital Care

https://clinicaltrials.gov/study/NCT03269487

PERFECTED

COMPLETED

This study is part of the 5-year long (2013-18) PERFECTED (Peri-operative Enhanced Recovery hip-fracture Care of paTiEnts with Dementia) National Institute for Health Research (NIHR) funded research programme. PERFECTEDs aim is to develop and pilot an evidence-based intervention to improve the hospital care of patients living with dementia who have fractured their hip. This protocol relates to Work Package 2 (WP2) of PERFECTED only. By working collaboratively with local clinicians and stakeholders, an action research (plan-do-study-act) approach will be used to generate knowledge to understand how to best implement the intervention (PERFECTED Enhanced Recovery Pathway), which was developed from learning and research undertaken as part of Work Package 1. During the current study the PERFECTED Enhanced Recovery Pathway (ERP) will be used to optimise care on three ortho-geriatric wards for 12 months. These wards are located in Norfolk, Nottinghamshire and Yorkshire. The sole participants are NHS personnel delivering care on selected wards. Data collection activities (observations, in-field interviews, documentary analysis and quantitative data generated from the PERFECTED ERP implementation checklist) will determine the staff training and cultural changes required to implement and maximise adherence to the PERFECTED ERP. Simultaneously, enabling the identification and exploration of areas of optimised, satisfactory and sub-optimal care. By working in partnership within and across the partner wards, action plans to address sub-optimal care will be generated, implemented and reviewed. Findings will inform the best ways to optimise care via the implementation of the PERFECTED ERP. Knowledge generated during this study will be used to develop an ERP and staff training manual. This will aid implementation of the intervention arm of a latter Cluster Randomised Control Trial (Work Package 3), ensuring the PERFECTED ERP can be utilised in the real world. As part of PERFECTEDs commitment to Public Patient Involvement (PPI), lay researchers will be trained to assist with qualitative research activities.

NO

Implementation of Enhanced Recovery Pathway

PERFECT-ER, Improvement toolkit, 12 months

University of East Anglia

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

v1 01.04.2015

2015-08-01

2016-07-01

2016-09-01

2017-08-31

2017-08-31

{}

NCT05098587

Brain Activity Patterns in Persons With Spinal Cord Injury and Neuropathic Pain After a Virtual Walking Training Program

https://clinicaltrials.gov/study/NCT05098587

VRandMRI

COMPLETED

The aim of this pilot study is to explore the association of changes in pain perception with changes in brain activity (functional Magnetic Resonance Imaging (fMRI)) and metabolic (Magnetic Resonance Spectroscopy (MRS)) patterns of individuals with SCI and chronic NeP after a Virtual Walk (VW) therapy. The brain activity patterns will be assessed in resting state and under a specific task, before and after a VW training program, done as part of the clinical routine, as well as at a four weeks follow-up. The results of this pilot study will serve as basis for a bigger project that aims to investigate and compare brain activity and long-term effects of non-immersive VW therapy on chronic NeP in individuals with SCI (traumatic SCI with chronic NeP at- or below level, complete or incomplete) taking into account confounding factors such as time since injury, level of injury and type of NeP.

NO

Spinal Cord Injuries|Neuropathic Pain

Change of N-Acetyl-Aspartate in the anterior cingulate cortex, Non-invasive MRI-based metabolic marker measured under various conditions (resting state, painful images, non-painful images), Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)

Change of Choline, Non-invasive MRI-based metabolic marker (resting state, painful images, non-painful images), Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Alteration of Creatine, Non-invasive MRI-based metabolic marker, Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Alteration of myo-Inositol, Non-invasive MRI-based metabolic marker, Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|BOLD signal changes during task-based and resting state functional MRI, Task-based and resting state functional MRI sequences are applied and BOLD signal changes are examined. A whole-brain and seed-based connectivity analysis are used and linked to pain processing and perception., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Pain diary, A pain diary using the numeric pain rating scale from 0 = no pain at all to 10 = worst imaginable pain , to assess pain intensity during the course of the study and in follow-up., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Pain description list, Questionnaire containing 12 descriptions of pain to assess the quality of pain (how the pain is perceived) Patients have to rate each description on a scale ranging from 0 = completely disagree to 3 = fully agree Items 1 to 8 are only descriptively evaluated. The sum of items 9 to 12 is the affective score whereas a high value is indicating a high affective burden and a low value is equal to a low affective burden., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Chronic pain grading scale, Questionnaire to assess the severity of chronic pain and its impact on daily activities containing 7 items that must be rated on a NRS ranging from 0 = no pain , no limitation ; to 10 = worst imaginable pain /limitation . Higher values thus indicating more pain/limitation., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|The Marburg questionnaire on habitual health findings, Questionnaire to assess general wellbeing containing 7 items that have to be rated on a rating scale ranging from 0 = completely disagree to 5 = completely agree . A high score in this questionnaire indicates high well-being., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|WHO-QoL-BREF, Questionnaire containing 26 items to assess quality of life rated on a rating scale ranging from 1 = very bad / very unhappy / not at all / never to 5 = very good / very happy / absolutely / always . Depending on the statements the scores have to be inversed to calculate the score. Higher scores indicate better quality of life. There are four domain scores that result from this questionnaire: physical domain, psychological domain, social relationships domain and environment domain., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Pain catastrophizing scale, Questionnaire containing 13 items/statements to assess pain catastrophizing on a rating scale ranging from 0 = never true to 4 = always true . A high score indicates a high degree of pain catastrophizing., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Questions about pain chronification, Questionnaire to assess pain chronification consisting of ten questions. The single questions help to classify the stadium of pain chronification ranging from stadium I = mild chronification to stadium III = heavy chronification., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|SCI independence measure III - self-reported version, Questionnaire addressing the functional impairment including 17 items assessing the grade of necessary aid versus ability to do it on their own for specific daily activities with ratings ranging from 0 = not able to do a task to 8 = no or minimal aid . The higher the score the more independent the person., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Depression, Anxiety & Stress Scale, Questionnaire to assess depression, anxiety and stress using 21 items rated on a scale from 0 = absolutely disagree or never to 3 = strong agreement or most of the time . Because the items are negatively formulated a high score indicates a high grade of depression, anxiety or stress. Each domain score consists of 7 items., Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)|Patient Global Impression of Change, One question to assess the subjective global impression of change after the therapy. The choice options range from very much better than before to very much worse than before with unchanged as the middle/neutral value., Two measurement time points: only T2 (six weeks after baseline) and T3 (ten weeks after baseline))

Sociodemographic and clinical characteristics, Collected during clinical routine: age, sex, pain duration, age at injury, lesion level, comorbidities, concomitant injuries, pain severity, pain distribution and quality, medication, education level, workability, functional impairment, motor imagery capacity and habits like smoking, quantity of alcohol or caffeine-containing potables., At the beginning and at follow up.

Swiss Paraplegic Research, Nottwil

Haute Ecole de Santé Vaud

ALL

ADULT, OLDER_ADULT

NETWORK

OBSERVATIONAL

Observational Model: |Time Perspective: p

2020-13

2021-08-30

2023-01-10

2023-01-10

2021-10-28

2024-03-08

Swiss Paraplegic Centre; Centre for pain medicine, Nottwil, Lucerne, 6207, Switzerland

{}

NCT04884087

EMA of Substance Use in Homeless Youth

https://clinicaltrials.gov/study/NCT04884087

COMPLETED

The proposed study will provide critical information on Ecological Momentary Assessment (EMA) design characteristics that promote retention in a vulnerable and under-represented population in research-youth experiencing homelessness. The study will use an EMA app to collect substance use, mood, craving, social surroundings, and trauma measures over a 14-day period in youth age 18-24 (n=40) recruited from Star House, a homeless youth drop-in center. Youth will be randomized in 2x2 factorial design (fixed incentive model vs. prize-based model; random assessment 3x vs. 6x per day).

NO

Substance Use

BEHAVIORAL: Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day|BEHAVIORAL: Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day|BEHAVIORAL: Incentive Structure - fixed|BEHAVIORAL: Incentive Structure - prize based

Length of Time, Total length of time in days using EMA (range: 1-14 days). Higher values represent greater length of time EMA was used., Baseline to end of trial (day 14)|Percent Completion, Percent of EMA surveys completed (0-100%). Higher values represent a larger percentage of EMA surveys completed., Baseline to end of trial (day 14)

Nationwide Childrens Hospital

ALL

ADULT

OTHER

INTERVENTIONAL

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

STUDY00000809

2021-02-24

2021-06-30

2021-06-30

2021-05-12

2023-03-17

Nationwide Childrens Hospital, Columbus, Ohio, 43205, United States

{ "Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day": [ { "intervention_type": "BEHAVIORAL" } ], "Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day": [ { "intervention_type": "BEHAVIORAL" } ], "Incentive Structure - fixed": [ { "intervention_type": "BEHAVIORAL" } ], "Incentive Structure - prize based": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04802187

Implementation of COVID-19 Testing Strategies in Community Health Centers

https://clinicaltrials.gov/study/NCT04802187

COMPLETED

This project is part of a competitive revision to accelerate COVID-19 testing in underserved populations. The overall aim is to implement strategies to expand COVID testing in hotspot communities in MA, through 6 community health center (CHC)-community partnerships. A base strategy will be implemented at all sites. A tailored strategy unique to local populations will be added and tested in a stepped wedge design.

YES

Covid19

OTHER: RADx CHCs testing intervention strategy|OTHER: Usual care control

Percentage Change in Testing During the Study Compared to Tests Completed Prior to Study Start, Acceleration of covid testing volume during covid surges, estimated as the percent change in weekly covid testing volume trend for each 10% increase in covid cases. A slope value was estimated from a segmented regression model for the entire study period, which was then used to calculate a difference between the post- and pre-implementation periods., 85 weeks post-implementation compared to 35 weeks pre-implementation

Massachusetts General Hospital

Dana-Farber Cancer Institute|Harvard School of Public Health (HSPH)|Massachusetts League of Community Health Centers|National Cancer Institute (NCI)

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2020P003743|3P50CA244433-02S1

2020-12-01

2022-07-15

2022-07-15

2021-03-17

2023-11-08

2023-11-08

Massachusetts League of Community Health Centers, Boston, Massachusetts, 02108, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/87/NCT04802187/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT04802187/SAP_001.pdf

{ "RADx CHCs testing intervention strategy": [ { "intervention_type": "OTHER" } ], "Usual care control": [ { "intervention_type": "OTHER" } ] }

NCT02758587

Study of FAK (Defactinib) and PD-1 (Pembrolizumab) Inhibition in Advanced Solid Malignancies (FAK-PD1)

https://clinicaltrials.gov/study/NCT02758587

UNKNOWN

This study will explore whether defactinib (a FAK inhibitor) can be safely and tolerably combined with pembrolizumab (a PD-1 inhibitor) and will look for early indications of improved anticancer immunotherapy. It will focus on three key cancers, all in clear need of improved therapies - NSCLC, pancreatic cancer and mesothelioma.

NO

Carcinoma, Non-small-cell Lung|Mesothelioma|Pancreatic Neoplasms

DRUG: Defactinib|DRUG: Pembrolizumab

Adverse events (AEs) using CTCAE v4.03 (to determine dose limiting toxicities (DLTs) and maximum tolerated dose (MTD)), Evaluate the tolerability profile and optimal dose of defactinib in combination with pembrolizumab, using CTCAE v4.03 Adverse Event recording., 6 months

Objective response rate (ORR), using best objective response by irRECIST, Evaluate the response rate, by irRECIST, of the combination of defactinib and pembrolizumab in patients with advanced solid malignancies., 3 years|Duration of response (DoR), Evaluate the duration of responses, by irRECIST, of the combination of defactinib and pembrolizumab in patients with advanced solid malignancies. Duration will be measured from the first scan showing radiological response (CR or PR), until (irRECIST confirmed) progression., 3 years|Progression free survival (PFS), Evaluate progression free survival of the combination of defactinib and pembrolizumab in patients with advanced solid malignancies. Duration will be measured from enrolment, until (irRECIST confirmed) progression., 3 years|Change in FAK Y397 phosphorylation, change in FAK Y397 phosphorylation between baseline biopsy and a repeat biopsy afer 2 weeks of therapy, 2 weeks|Change in immune cell infiltrate, change in immune cell infiltrate between baseline biopsy and a repeat biopsy after 2 weeks of therapy, 2 weeks

NHS Greater Glasgow and Clyde

University of Glasgow|Cancer Research UK|Merck Sharp & Dohme LLC|Verastem, Inc.|University of Edinburgh|University of Southampton|University of Leicester|Queens University, Belfast

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

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

GN15ON133|2015-003928-31

2017-07-04

2019-05

2021-12

2016-05-02

2018-03-19

Belfast Health and Social Care Trust, Cancer Centre, Lisburn Road, Belfast, BT9 7BL, United Kingdom|Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, EH4 2XR, United Kingdom|Beatson West of Scotland Cancer Centre, Glasgow, G12 0YN, United Kingdom|Department of Cancer Studies, University of Leicester, Leicester Royal Infirmary, Leicester, LE2 7LX, United Kingdom|Cancer Research UK Centre, Southampton University Hospitals and University of Southampton, Southampton, SO16 6YD, United Kingdom

{ "Defactinib": [ { "intervention_type": "DRUG", "description": "Defactinib", "name": "Defactinib", "synonyms": [ "Defactinib", "N-methyl-4-[[4-[[3-[methyl(methylsulfonyl)amino]pyrazin-2-yl]methylamino]-5-(trifluoromethyl)pyrimidin-2-yl]amino]benzamide" ], "drugbank_id": "DB12282", "generic_names": [ "Defactinib" ] } ], "Pembrolizumab": [ { "intervention_type": "DRUG", "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" } ] }

NCT02384187

Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients

https://clinicaltrials.gov/study/NCT02384187

COMPLETED

The frequent incidence of postoperative vomiting and severe pain in children undergoing adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration. Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of patients, with a reported incidence ranging from 23% to 73%. There is growing evidence that the perioperative administration of gabapentinin in adults is beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative nausea and vomiting, and delirium. Only few studies in literature explored the analgesic effects of preoperative gabapentin as premedication in pediatric population. However, the antiemetic effect of gabapentin in pediatric patients was not systematically investigated before.

NO

Post Operative Nausea and Vomiting (PONV)|Adenotonsillectomy

DRUG: Gabapentin as premedication|DRUG: placebo

Incidence of PONV, The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively, over the first postoperative 6 hours

Pediatric Anesthesia Behavior score (PAB), the score will be assessed during induction of anesthesia. The child will be scored 1 if Happy; 2 if Sad; and 3 if Mad., within10 minutes before the child falls asleep.|Incidence and severity of postoperative delirium, Emergence agitation scores will be recorded every10 min for the first 60 minutes postoperatively, up to 60 minutes after the end of the operation.|Duration of recovery, The extubation time will be the time interval from discontinuation of sevoflurane until removal of the endotracheal tube. The time to interaction will be the time from discontinuation of sevoflurane until verbal contact or response to commands., up to 60 minutes after the end of surgery.|Time to first request of postoperative rescue analgesics., the time interval between the end of surgery and the first request to postoperative analgesia, over the first postoperative 6 hours|Postoperative analgesic consumption, over the first postoperative 6 hours|Objective pain scale (OPS), The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively., over the first postoperative 6 hours

Cairo University

ALL

CHILD

PHASE3

OTHER

INTERVENTIONAL

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

N-47-2014

2015-01

2015-05

2015-08

2015-03-10

2015-12-23

Kasr Al Ainy, Cairo, 11562, Egypt

{ "Gabapentin": [ { "intervention_type": "DRUG", "description": "Gabapentin as premedication", "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" } ], "placebo": [ { "intervention_type": "DRUG" } ] }

NCT06172387

Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for

https://clinicaltrials.gov/study/NCT06172387

ACTIVE_NOT_RECRUITING

Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.

NO

Acute Ischemic Stroke

DRUG: intra-arterial infusion albumin|OTHER: mechanical thrombectomy and a standard clinical therapy

cerebral infarct volume, infarct volume is evaluated mainly through brain MRI, 24-48 hours after randomization

modified Rankin Scale score(mRS), the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death), 90 ±10 days after randomization|the good prognosis at 90 days assessed by mRS, the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death), 90 ±10 days after randomization|scores assessed by National Institutes of Health Stroke Scale (NIHSS), the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits, 24 ± 6 hours, 48 ± 12 hours, 7 ± 2 days, 90 ±10 days after randomization|change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours, the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits, from baseline to 24 ± 6 hours|improvement of neurologic function after 24 hours, NIHSS score decreased by more than 4 points or NIHSS score was 0; secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severs deficits), 24 ± 6 hours after randomization|Barthel index (BI), the BI is an ordinal disability score of 10 categories (range from 0-100, higher values indicate better prognosis), 90 ±10 days after randomization|revascularization on follow-up imaging, secondary imaging efficacy endpoint, 24 (16 to 36) hours|24-hours neurologic deterioration, NIHSS score increased by more than 4 points; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits); clinical safety endpoint, 24 ± 6 hours after randomization|any intracranial hemorrhage on follow-up imaging, imaging safety endpoints; per ECASSIII definition and per Heidelberg bleeding classification, 24 (12 to 36) hours|symptomatic intracerebral hemorrhage, imaging safety endpoints; deterioration in NIHSS score of ≥4 point within 24 hours;per ECASS III definition and per Heidelberg bleeding classification, 24 (12 to 36) hours|Mortality, clinical safety endpoint, 90 ± 10 days after randomization|Stroke recurrence, clinical safety endpoint, 90 ± 10 days after randomization|Survival rates, secondary clinical efficacy endpoint, 7 ± 2 days, 90 ± 10 days after randomization|mRS4-6, secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death), 90 ± 10 days after randomization

Tianjin Huanhu Hospital

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

TJHH-2023-WM121

2023-11-01

2024-12

2024-12

2023-12-15

2023-12-15

Ming wei, Tianjin, China, Tianjin, 300222, China

{ "intra-arterial infusion albumin": [ { "intervention_type": "DRUG" } ], "mechanical thrombectomy and a standard clinical therapy": [ { "intervention_type": "OTHER" } ] }

NCT01866787

Study on Baroreceptor Function in Relation to Orthostatic Blood Pressure Regulation After Hip Surgery

https://clinicaltrials.gov/study/NCT01866787

UNKNOWN

The purpose of this observational study is to evaluate the baroreceptor function in relation to surgical inflammation and orthostatic intolerance after elective hip arthroplasty. The main hypothesis is that baroreceptor function is attenuated after surgery and related to surgical inflammation.

NO

Hypotension, Orthostatic|Total Hip Replacement

Change in baroreceptor function from preoperatively to 6 hours after surgery, Change in baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment before and 6 hours after surgery., 6 hours after surgery

Orthostatic response in blood pressure, The response in systolic and diastolic blood pressure during postural change from supine to standing, Preoperative, 6 and 24 hours after surgery|Orthostatic response in heart rate variability, Heart rate variability during supine rest, sitting and standing as assessed by Spectral analysis., preoperative, 6 and 24 hours postoperative|Orthostatic intolerance, Orthostatic intolerance defined as the inability to sit or stand for 3 minutes due to presyncopal symptoms (Dizziness, Nausea, Blurred vision)., preoperative, 6 and 24 hours after surgery|Inflammatory markers, Inflammatory markers (CRP and interleukin-6) measured at 3 separate timepoint: preoperative, 6- and 24 h after surgery, preoperative, 6 and 24 hours postoperative|Orthostatic Hypotension, orthostatic hypotension defined according to international guidelines., Preoperative, 6 and 24 hours postoperative.|Baroreceptor function, baroreceptor function as expressed by change in the blood pressure valsalva ratio during a standardized assessment, On the day of surgery: preoperatively, 6- and 24 hours after surgery

Rigshospitalet, Denmark

Lundbeck Foundation

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RH-4074-OJ3

2013-01

2015-12

2015-12

2013-05-31

2015-01-16

Frederiksberg Hospital, Department of orthopaedic surgery, Frederiksberg, 2000, Denmark

{}

NCT02521987

Port Size and Post-Operative Pain Perception by Patients

https://clinicaltrials.gov/study/NCT02521987

COMPLETED

The purpose of this study is to determine if there is a difference in pain perception by participants when the assistant port size varies by 50% (8 mm to 12 mm).

NO

Pain

PROCEDURE: 8mm port|PROCEDURE: 12mm port

Participants will be asked to specify the point that represents their level of perceived pain intensity and mark it on the VAS at four time points., Measured with Visual Analog Scale (VAS) for pain at 1) baseline pain prior to the procedure in the pre-operatively holding area, 2) 4-6 hours post-operatively in the post-anesthesia care unit (PACU), 3) on post-operative day 1(POD1) and 4) once two weeks post operatively., 2 weeks post-op visit

What is the physicians perception of operative difficulty throughout the case? Determination of physician struggle and frustration will be documented., This will be measured by recording the time the first suture is placed when the physician asks for the mesh, to the time the incision is closed., Day of surgery

Loyola University

FEMALE

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: PREVENTION

207726

2015-08-01

2017-11-16

2017-11-16

2015-08-13

2018-02-01

Loyola University Medical Center, Maywood, Illinois, 60153, United States

{ "8mm port": [ { "intervention_type": "PROCEDURE" } ], "12mm port": [ { "intervention_type": "PROCEDURE" } ] }

NCT03831087

Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement

https://clinicaltrials.gov/study/NCT03831087

TAVR-CMR

COMPLETED

To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.

NO

Aortic Stenosis

DIAGNOSTIC_TEST: TAVR-CMR|DIAGNOSTIC_TEST: TAVR-CT

The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria., The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient < 20mmHg and no valve regurgitation > mild), 6 months

Medical University Innsbruck

Johannes Kepler University of Linz|Klinikum Wels-Grieskirchen

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

20171002-1653

2017-10-30

2023-08-05

2023-08-05

2019-02-05

2023-08-09

University Clinic of Internal Medicine III, Innsbruck, Tirol, 6020, Austria

{ "TAVR-CMR": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "TAVR-CT": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT04401787

Converted Laparoscopic Resection of Upper Rectal Carcinoma T1-4 N0-1 in Obese Patients.

https://clinicaltrials.gov/study/NCT04401787

COMPLETED

Background: laparoscopic resection (LAR) is a safe approach and widely used for rectal cancer after neoadjuvant chemo-radiotherapy, but short term and oncological outcome for converted cases to open surgery (cLAR), may be questioned in an obese patient. Objective: validating the short-term and oncological outcomes after laparoscopic resection and after conversion to open surgery for upper rectal cancer in obese patients. Patients and methods: A prospective study included 191 patients, randomly allocated into two arms of the study, Arm I is open anterior resection (OAR), this is the control and arm II, The LAR. Only 156 analyzed.

NO

Cancer, Rectum

PROCEDURE: Anterior resection for upper rectal cancer in obese

recovery time-intraoperative bleeding, up to 3 years|Incidence of wound infection, up to 3 years|hospital stay-perioperative length, up to 3 years|oncological outcome, total mesorectal excision, margin included or not, 3 years

early locoregional recurrence, early locoregional recurrence within 6 months, 6 months

Zagazig University

ALL

ADULT, OLDER_ADULT

OTHER_GOV

INTERVENTIONAL

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

IR-20780302-1

2016-12-11

2019-12-29

2020-05-18

2020-05-26

2020-05-26

{ "Anterior resection for upper rectal cancer in obese": [ { "intervention_type": "PROCEDURE" } ] }

NCT03118687

Human Immunome Program

https://clinicaltrials.gov/study/NCT03118687

HIP

COMPLETED

The Human Immunome Program is a large-scale, open-source effort seeking to fill a major gap in our knowledge of the immune system. The power of the immune system to fight disease lies in its ability recognize and adapt to an astonishing range of threats from viruses, parasites and bacteria to cancer cells. Underlying this ability is a vast but specific set of genes and molecular structures known as the human immunome, or the parts list of the immune system. This study aims to decipher the genetic sequences that make up this part list and link it to information about a persons microbiome composition and characteristics such as health history, race, and demographics over time. This information, made freely available to the public for use in research in de-identified form, will allow investigators to answer a wide variety of different questions about immune system function. This could transform how we diagnose, prevent and treat disease though the identification of new biomarkers while enabling highly targeted, computationally designed vaccines and therapies that reduce time and risk of product development.

NO

Healthy

OTHER: Biospecimen and survey collection

The entire expressed B and T cell receptor repertoire ( Immunome ) of the human immune system, The B and T cell receptor repertoire will be sequenced. The sequencing will continue until no new unique sequences appear., 10 years

Vanderbilt University Medical Center

Human Vaccines Project

ALL

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

IRB#170398

2017-07-01

2020-06-18

2020-06-18

2017-04-18

2021-02-08

Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States

{ "Biospecimen and survey collection": [ { "intervention_type": "OTHER" } ] }

NCT01394887

Metformin & Inflammation in Pre-diabetic Children

https://clinicaltrials.gov/study/NCT01394887

COMPLETED

Hypothesis. To determine the effect of metformin on the concentrations of resistin and other insulin resistance or inflammatory markers (C-reactive protein, cytokines, body weight, HbA1c, among others) in minors with glucose intolerance. Children with glucose intolerance are given either metformin or placebo for 12 consecutive weeks. High sensitivity C-reactive protein, TNF-alpha, IL-6, IL1-beta, resistin, leptin, adiponectin, glucose, insulin, HbA1c, lipid profile and transaminases are measured at the beginning and at the end of the period. Statistical analysis: t Student test; Friedman and Kruskal Wallis test are used. Variables are adjusted for: sex, age, baseline BMI and percentage weight change.

NO

Glucose Intolerance|Inflammation|Diabetes

DRUG: Metformin|DRUG: placebo

presence of inflammation, to determine the efficacy of metformin in avoiding deterioration of glucose intolerance to type 2 diabetes, as measured by inflammation through various recognized inflammation markers, 1 year

presence of type 2 diabetes, to determine the efficacy of metformin in avoiding deterioration of glucose intolerance to type 2 diabetes, as measured by inflammation through various recognized inflammation markers, 10 years

Coordinación de Investigación en Salud, Mexico

ALL

CHILD

PHASE2|PHASE3

OTHER_GOV

INTERVENTIONAL

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

2002-718-0018

2002-07

2003-07

2011-07

2011-07-15

2011-07-18

Endocrine Outpatient Clinic of the Hospital de Pediatria del CMN Siglo XXI , Mexico City, DF, 06720, Mexico

{ "Metformin": [ { "intervention_type": "DRUG", "description": "Metformin", "name": "Metformin", "synonyms": [ "Dimethylbiguanidine", "Dimethylguanylguanidine", "Fortamet", "Metabet", "Metformin HCl", "Hydrochloride, Metformin", "Metformin", "Metformin Hydrochloride", "Diagemet", "Metformina", "Glumetza", "Trijardy", "Metforminum", "Glucient", "Glucophage", "Axpinet", "Dimethylbiguanid", "Metformine", "1,1-Dimethylbiguanide", "HCl, Metformin" ], "medline_plus_id": "a696005", "generic_names": [ "Metformin" ], "nhs_url": "https://www.nhs.uk/medicines/metformin", "mesh_id": "D007004", "drugbank_id": "DB00331", "wikipedia_url": "https://en.wikipedia.org/wiki/Metformin" } ], "placebo": [ { "intervention_type": "DRUG" } ] }

NCT03100487

Efficacy of Audio Recorded Guided Imagery vs Deep Breathing Exercises on Functional Gastrointestinal Pain Disorders

https://clinicaltrials.gov/study/NCT03100487

COMPLETED

The purpose of this study is to: 1. Determine if audio recorded guided imagery vs deep breathing exercises delivered via a digital media player improves abdominal pain symptoms in children with functional gastrointestinal pain disorders managed in the primary care setting. 2. Determine if audio recorded guided imagery and deep breathing exercises delivered via a digital media player improves psychosocial distress in children affected by functional gastrointestinal pain disorders managed in the primary care setting. The possibility of treating functional gastrointestinal pain disorders using remotely delivered psychosocial therapies has the potential to treat many children affected by functional gastrointestinal pain disorders in a cost-effective manner. This study will provide insight into how well these patients in the primary care could benefit from such interventions.

NO

Abdominal Pain|Functional Gastrointestinal Disorders

DEVICE: Apple iPod Shuffle

Change in abdominal pain symptoms, Abdominal Pain Index, Change from Baseline to 8 weeks post-treatment

Improvement in health-related quality of life, Pediatric Quality of Life Inventory (Peds QL) Questionnaire, Change from Baseline to 8 weeks post-treatment|Change in Psychosocial Distress, Behavior Assessment System for Children (BASC 3) Questionnaire, Change from Baseline to 8 weeks post-treatment|Adherence to Intervention, Count of Number of Sessions Played, 8 weeks after treatment

Baylor College of Medicine

ALL

CHILD

OTHER

INTERVENTIONAL

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

H-39390

2016-08

2018-09

2018-09

2017-04-04

2023-09-21

Texas Childrens Hospital, Houston, Texas, 77030, United States

{ "Apple iPod Shuffle": [ { "intervention_type": "DEVICE" } ] }

NCT00152087

A Non-Randomized Study of Internal Radiation Therapy to the Liver in Patients With Primary Liver Cancer for Whom Surgery is Not Possible.

https://clinicaltrials.gov/study/NCT00152087

UNKNOWN

Surgical resection of the affected liver offers the best chance for disease-free survival in patients with Hepatoma (HCC). Unfortunately, most hepatoma patients present with disease which is multi-focal and thus not resectable. Fewer than 15% of HCC patients are resectable. The objective of treatment with TheraSphere is to selectively administer a dose of radioactive material directly to neoplastic tissue in the liver. Systemic therapy is largely ineffective.

NO

Liver Cancer

DEVICE: Brachytherapy

Efficacy|- Response to treatment|- Survival time from treatment|Safety:|- Adverse experience

St. Josephs Hospital, Florida

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

SJCI015|Alison Calkins, MD|Matthew Berlet, MD

2002-10

2005-06

2005-09-09

2005-09-09

St. Josephs Hospital, Tampa, Florida, 33607, United States

{ "Brachytherapy": [ { "intervention_type": "DEVICE" } ] }

NCT00500487

Therapeutic Schools: Affect Management and HIV Prevention

https://clinicaltrials.gov/study/NCT00500487

COMPLETED

Adolescents are at risk for HIV because of sexual and drug behavior intiated during this developmental period. Those with psychological distress are less likely than their peers to benefit from frequently used skills-based interventions. It appears that emotional lability during sexual situations disrupts skills learned. This project will implement and evaluate interventions for adolescents with psychiatric disorders who are in therapeutic school settings. Affect management and skills-based interventions will be compared to a didactic standard of care condition to determine which intervention best reduces risk behavior among adolescents with psychiatric disorders in therapeutic school settings.

NO

HIV Infections

BEHAVIORAL: Affect Management|BEHAVIORAL: HIV Prevention Skills|BEHAVIORAL: General Health Promotion

Adolescent-reported condom use, 1 year

Rhode Island Hospital

University of Chicago

ALL

CHILD, ADULT

PHASE1

OTHER

INTERVENTIONAL

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

R01MH066641|R01MH066641

2003-04

2010-06

2010-06

2007-07-12

2015-01-12

Rhode Island Hospital, Providence, Rhode Island, 02903, United States

{ "Affect Management": [ { "intervention_type": "BEHAVIORAL" } ], "HIV Prevention Skills": [ { "intervention_type": "BEHAVIORAL" } ], "General Health Promotion": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01169987

Evaluation of Humira Retention Rate in Psoriasis Patients in Daily Practice and Assessment of Work Productivity and Quality of Life

https://clinicaltrials.gov/study/NCT01169987

COMPLETED

This observational study will document to what extent in daily clinical practice Humira (adalimumab) therapy is continued, interrupted or permanently discontinued during a follow-up period of 2 years. Reasons for interrupting or permanently discontinuing Humira therapy and reasons for restarting Humira therapy will be noted. An evaluation will be performed of the effect of the disease on quality of life and work productivity.

YES

Psoriasis

Adalimumab Treatment Retention Status, Percentage of participants with an adalimumab treatment status of continuous, early intermittent, late intermittent, permanently discontinued, or other. Continuous=initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study. Early intermittent=initiated on adalimumab 40 mg, treated every other week (EOW) for < 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study. Late intermittent=initiated on adalimumab 40 mg, treated EOW for ≥ 112 days (16 weeks) after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study. Permanently discontinued=received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently. Other=participants not belonging to any of the previous groups., Month 24/ Early Termination visit

Psoriasis Area and Severity Index (PASI): Mean Percentage Improvement From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status, Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed with PASI for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|PASI: Percentage Improvement Change Categories From Baseline for All Participants and Broken Down by Adalimumab Treatment Retention Status, Percentage of participants who achieved ≥ 50%, 75%, 90% or 100% reduction (improvement) from Baseline in PASI score (PASI50, PASI75, PASI90, PASI100). Four anatomic sites (head, upper extremities, trunk, and lower extremities) were assessed for erythema, induration (plaque thickness), and desquamation (scaling) as seen on the day of the examination. The severity of each sign was assessed using a 5-point scale: 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. PASI percentage improvement=100*(PASI score at Baseline - score at follow-up visit) / PASI score at Baseline. For the purpose of analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based on the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|Mean Percent Affected Body Surface Area (BSA) For All Participants and Broken Down by Adalimumab Treatment Retention Status, Clinical psoriasis evaluations by the investigator of percentage of affected BSA. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|Physicians Global Assessment (PGA): Percentage of Participants in Regrouped PGA Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status, The PGA was an evaluation of a participants psoriasis on a 6-point scale: clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5), which were then regrouped into the 2 categories Clear/Minimal or Mild/Moderate/Severe/Very Severe (M/Md/S/VS), and presented as the percentage of participants in each. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (obs.; up to 24 months)|Dermatology Life Quality Index (DLQI): Mean Score for All Participants and Broken Down by Adalimumab Treatment Retention Status, DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participants skin has affected certain behaviors and quality of life over the last week. Responses to each question are: very much (3), a lot (2), a little (1), or not at all (0). The total DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows, based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|DLQI: Percentage of Participants in DLQI Categories for All Participants and Broken Down by Adalimumab Treatment Retention Status, DLQI is a participant-reported outcome consisting of 10 questions regarding the degree to which the participants skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot (score of 2), a little (score of 1), or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The following scoring categories present the effect on participants life: 0-1 no effect at all; 2-5 small effect; 6-10 moderate effect; 11-20 very large effect; 21-30 extremely large effect. Follow-up visits were classified into time windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|Work Productivity and Activity Impairment (WPAI) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status, Absenteeism, presented as the mean percentage of work time missed due to psoriasis (as reported on the WPAI), and calculated as: 100*number of hours of work missed due to psoriasis / (number of hours of work missed due to psoriasis + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|WPAI Questionnaire: Mean Percentage of Impairment While Working Due to Psoriasis (Presenteeism) for All Participants and Broken Down by Adalimumab Treatment Retention Status, Presenteeism (the extent to which psoriasis decreased productivity) is presented as the mean percentage of impairment while working due to psoriasis, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|WPAI Questionnaire: Mean Percentage of Total Work Productivity Impairment (TWPI) Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status, The mean percentage of TWPI due to psoriasis (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which psoriasis decreased productivity (%)* [number of hours worked / (number of hours of work missed due to psoriasis + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)|WPAI Questionnaire: Mean Percentage of Activity Impairment Due to Psoriasis for All Participants and Broken Down by Adalimumab Treatment Retention Status, Activity impairment due to psoriasis (the extent to which psoriasis affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. For the purpose of the analysis of the evolution of parameters over time, follow-up visits were classified into time-windows (TWs), based upon the number of days between onset of adalimumab treatment and the date of each subsequent visit: TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730)., Baseline, TW 3 months=period between Day 1 and 137 (target, Day 91); TW 12 months=period between Day 275 and 456 (target, Day 365); TW 24 months=period starting on Day 640 (target Day 730); last observation (up to 24 months)

AbbVie (prior sponsor, Abbott)

Veeda Clinical Research

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

P12-129

2010-05

2015-03

2015-03

2010-07-27

2016-06-14

2016-07-13

{}

NCT00380887

Study Comparing Four New Formulations for Premarin in Healthy Postmenopausal Women

https://clinicaltrials.gov/study/NCT00380887

COMPLETED

The purpose of this study is to determine bioequivalence and bioavailability of four different Premarin/MPA test formulations versus the current formulation for Prempro.

NO

Postmenopause

DRUG: Premarin

Wyeth is now a wholly owned subsidiary of Pfizer

FEMALE

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

0713E1-133, 0713E1-135

2005-06

2006-09-27

2006-09-27

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

NCT02528487

Predictors of the Long-term Functional Benefits of a Pulmonary Rehabilitation Program?

https://clinicaltrials.gov/study/NCT02528487

SUSPENDED

The present study aims to assess the prevalence and impact of comorbid psychiatric disorders among patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation (PR), in order to determine the effects of psychiatric comorbidity on exercise tolerance and physical activity post-PR and HRQoL, as well as to determine the processes by which these psychiatric disorders may impact on these patient behaviours.

NO

Chronic Obstructive Pulmonary Disease

The change in exercise tolerance at 1-year post-PR, Exercise tolerance will be measured with the 6-minute walking test (6MWT)., Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.

The change in health-related quality of life (HRQoL) at 1-year post-PR, HRQoL will be measured with the 12-Item Short Form Survey and the COPD Assessment Test, Participants will be evaluated at 3 time points: (1) post-PR; (2) at 6-mo; (3) at 12-mo follow-up.

Hopital du Sacre-Coeur de Montreal

Mount Sinai Rehabilitation Hospital|Hopital Charles Lemoyne|Centre hospitalier de lUniversité de Montréal (CHUM)|Jewish Rehabilitation Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2015-1132 (MP)

2015-05

2023-03

2023-03

2015-08-19

2019-03-15

Jewish Rehabilitation Hospital, Laval, Quebec, Canada|Hopital Charles-Lemoyne, Longueuil, Quebec, Canada|Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, H4J1C5, Canada|Centre hospitalier de lUniversité de Montréal (CHUM), Montreal, Quebec, Canada|Mount-Sinai Hospital, Montreal, Quebec, Canada

{}

NCT04809987

Effectiveness of Virtual Gait System Intervention in Motor Function in People With Incomplete Spinal Cord Injury.

https://clinicaltrials.gov/study/NCT04809987

ACTIVE_NOT_RECRUITING

Roughly 60% of people with Spinal Cord Injury (SCI) have an incomplete one, with a strength, sensibility, and muscle tone alteration. Moreover, this condition involves a high impact on the psychological and socioeconomic levels. After an incomplete SCI, spontaneous functional recovery occurs. This recovery is strong associated with injury and person characteristics, and with corticospinal fibers, motor cortex, and spinal neurons neuroplasticity. However, also it is possible to stimulate neuroplasticity mechanisms of these structures throughout rehabilitation techniques. Generally, with external devices, exoskeletons, or physical exercise therapy. With it, clinicians achieve early, intensive and specific therapies. This reorganization and recovery can be influenced because of mirror neurons, located in motor and premotor areas, and in other cortical and subcortical areas. These types of neurons are activated with a functional action observation. Due to incomplete SCI neuroplasticity recover, these therapies (concretely, illusion visual systems) have been the object of systematic review in this population with the aim of knowing its repercussion on neuropathic pain in chronic patients. Moseley and collaborators in 2007 were the first of proposing a virtual gat system that induced patients gait illusion. The promising results in this intervention, leading institutions performed similar studies with other stimuli and devices, with good results. However, SCI studies are focused on neuropathic pain and not in motor function (like in other populations). Therefore, there is not any study that assesses mirror neurons activity in the physical condition and/or in functional gait capaity in incomplete spinal cord injury population. On the basis of the above, the study principal aim is to evaluate a virtual gait treatment effectiveness compared with combined interventions with specific gait physical exercise in functional capacity in the incomplete spinal cord injury population. Concretely in follow outcomes: gait, functionality, strength, muscle tone, sensibility, and neuropathic pain.

NO

Incomplete Spinal Cord Injury

OTHER: Virtual Gait|OTHER: Physical Exercise|OTHER: Documental projection

Gait, 10 meters Walking Test, 10 minutes|Functionality, FallSkip, 10 minutes|Strength, Load Cell, 10 minutes

Spasticity, MyotonPRO, 10 minutes|Neuropathic Pain, Brief Pain Inventory, 10 minutes|Muscle Activation, EMG, 10 minutes

University of Valencia

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

9102019

2020-01-09

2023-12-31

2024-12-31

2021-03-22

2023-12-06

Facultat de Fisioterapia, Universitat de València, Valencia, 46010, Spain|Faculty of Physiotherapy, Valencia, 46010, Spain

{ "Virtual Gait": [ { "intervention_type": "OTHER" } ], "Physical Exercise": [ { "intervention_type": "OTHER" } ], "Documental projection": [ { "intervention_type": "OTHER" } ] }

NCT04438187

Trial of Antimicrobial Restraint in Presumed Pneumonia

https://clinicaltrials.gov/study/NCT04438187

TARPP

COMPLETED

The objective of this cluster-randomized crossover study is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed ICU-acquired pneumonia without septic shock.

NO

Healthcare-Associated Pneumonia|Sepsis

OTHER: antimicrobial initiation

protocol adherence, as a pilot study the primary outcome will be protocol adherence as defined by using the criteria below: Aggressive Protocol: * Failure to send appropriate culture before initiation of antimicrobials in the absence of septic shock * Failure to stop antimicrobials in the absence of pneumonia or other documented infection after 72 hours. Conservative Protocol: * Failure to send appropriate culture * Initiation of antimicrobials (in the absence of septic shock, new onset or worsening organ dysfunction, or other indicated source of infection) without any objective evidence of pneumonia. * Failure to initiate antimicrobials in the setting of objective evidence of pneumonia. * Failure to stop antimicrobials in the absence of other documented infection if final cultures return as negative., by time of culture finalization or 1 week

In-hospital mortality, All-cause, by treatment protocol assignment (intent-to-treat), ICU mortality, pneumonia-related, until hospital discharge or 1 year|Days of antimicrobials administered, includes empiric, therapeutic, prophylactic, and perioperative antimicrobials, until hospital discharge or 1 year|Ventilator-free alive days, until hospital discharge or 1 year|ICU length of stay, Until discharge from ICU or 1 year|Hospital length of stay, until hospital discharge or 1 year

University of Kansas Medical Center

Western Michigan University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

145059

2021-02-01

2022-01-06

2022-06-30

2020-06-18

2022-11-16

KU Medical Center, Kansas City, Kansas, 66160, United States

{ "antimicrobial initiation": [ { "intervention_type": "OTHER" } ] }

NCT01810887

A Phase 4 Study to Evaluate Pharmacokinetics and Safety of Darunavir Along With Ritonavir in Healthy Male Japanese Participants

https://clinicaltrials.gov/study/NCT01810887

COMPLETED

The purpose of this study is to evaluate the pharmacokinetics (explores what the body does to the drug) and safety of darunavir, and will be administered in combination with Ritonavir in healthy adult Japanese male participants.

NO

Healthy

DRUG: Darunavir|DRUG: Ritonavir

Change in Plasma Darunavir Concentration, Plasma concentration of Darunavir will be determined by collecting blood samples at the defined time points., 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3|Maximum Plasma Concentration (Cmax) of Darunavir, The Cmax is the maximum plasma concentration., 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-infinity]) of Darunavir, The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant., 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3|Terminal Half-Life(t[1/2]) of Darunavir, Terminal half-life (t[(1/2]) is defined as 0.693/Lambda(z)., 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3|Time to reach maximum concentration (tmax) of Darunavir, The Tmax is time to reach the maximum plasma concentration., 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3|Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC [0-last]) of Darunavir, The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant., 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3|Apparent total body clearance (CL/F) of Darunavir, Clearance is a quantitative measure of the rate at which a drug substance is removed from the body. The CL/F will be calculated by dividing the dose by AUC (0-infinity), 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3|Apparent volume of distribution at the terminal Phase (Vd[z] /F) of Darunavir, Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.The Vd(z)/F will be calculated by dividing CL/F by lambda(z)., 0 hour (pre-dose) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 24, 48 and 72 hours post-dose of darunavir on Day 3

Change in Plasma Ritonavir Concentration, Plasma concentration of Darunavir will be determined by collecting blood samples at the defined time points., 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5|Maximum Plasma Concentration (Cmax) of Ritonavir, The Cmax is the maximum plasma concentration., 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5|Time to reach maximum concentration (tmax) of Ritonavir, The Tmax is time to reach the maximum plasma concentration., 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5|Area Under the Plasma Concentration-Time Curve From Time Zero to 12 hours (AUC [0-12]) of Ritonavir, The AUC (0-12) is the area under the plasma concentration-time curve from time zero to 12 hours, calculated as the sum of AUC(last) and C(last)/lambda(z), wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time; and C(last) is the last observed quantifiable concentration; and lambda(z) is elimination rate constant., 0 hour (pre-dose) on Day 1, 2, 3, 4 and 5

Janssen Pharmaceutical K.K.

MALE

ADULT

PHASE4

INDUSTRY

INTERVENTIONAL

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

CR100323|JNS011-JPN-01

2008-05

2008-07

2008-07

2013-03-14

2013-04-10

Tsukuba, Japan

{ "Darunavir": [ { "intervention_type": "DRUG", "description": "Darunavir", "name": "Darunavir", "synonyms": [ "Darunavir", "TMC 114", "114, TMC", "Darunavir Ethanolate", "UIC94017", "Prezista", "UIC 94017", "UIC-94017", "(3R,3aS,6aR)-tetrahydro-2H-furo[2,3-b]furan-3-yl (2S,3R)-4-(4-amino-N-neopentylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-ylcarbamate", "(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl N-((1S,2R)-1-benzyl-2-hydroxy-3-(N1-isobutylsulfanilamido)propyl)carbamate", "Darunavirum", "{(1S,2R)-3-[(4-Amino-benzenesulfonyl)-isobutyl-amino]-1-benzyl-2-hydroxy-propyl}-carbamic acid (3R,3aS,6aR)-(hexahydro-furo[2,3-b]furan-3-yl) ester", "TMC114", "N-((1S,2R)-3-(((4-aminophenyl)sulfonyl)(2-methylpropyl)amino)-2-hydroxy-1-benzylpropyl)((1S,2R,5R)-4,6-dioxabicyclo(3.3.0)oct-2-yloxy)carboxamide", "(3R,3aS,6aR)-tetrahydro-2H-furo[2,3-b]furan-3-yl (2S,3R)-4-(4-amino-N-isobutylphenylsulfonamido)-3-hydroxy-1-phenylbutan-2-ylcarbamate", "Prezcobix", "Ethanolate, Darunavir", "TMC-114", "[(S)-3-[(4-Amino-benzenesulfonyl)-isobutyl-amino]-2-hydroxy-1-((R)-phenylmethyl)-propyl]-carbamic acid (3R,3aS,6aR)-(hexahydro-furo[2,3-b]furan-3-yl) ester", "Prezcobix", "Darunavir and Cobicistat", "Rezolsta", "Prezcobix", "Darunavir/cobicistat", "Prezcobix", "Darunavir and Cobicistat", "Rezolsta", "Prezcobix", "Darunavir/cobicistat" ], "medline_plus_id": "a607042", "generic_names": [ "Darunavir", "Darunavir and Cobicistat", "Darunavir and Cobicistat" ], "mesh_id": "D017320", "drugbank_id": "DB01264", "wikipedia_url": "https://en.wikipedia.org/wiki/Darunavir" } ], "Ritonavir": [ { "intervention_type": "DRUG", "description": "Ritonavir", "name": "Ritonavir", "synonyms": [ "Norvir", "ABT538", "Ritonavir", "RTV", "ABT-538", "ABT 538", "Ritonavirum" ], "medline_plus_id": "a696029", "generic_names": [ "Ritonavir" ], "mesh_id": "D065692", "drugbank_id": "DB00503", "wikipedia_url": "https://en.wikipedia.org/wiki/Ritonavir" } ] }

NCT02237287

Combination of Taliderm® and Vacuum-assisted Closure (VAC) for Treatment of Pressure Ulcers

https://clinicaltrials.gov/study/NCT02237287

TERMINATED

Background: The wound healing promoting effect of negative wound pressure therapies (NWPT) takes place at the wound foam interface. Implementation of bioactive substances at this site represents a major research area for the development of future NWPT devices. Methods: Wound healing kinetics of pressure ulcers treated by vacuum assisted closure devices with or without the implementation of a thin interface of poly-N-acetyl glucosamine nanofibers (sNAG) was studied in a prospective randomized clinical trial.

NO

Wounds|Pressure Ulcer

OTHER: wound dressing with VAC and sNAG without antiaggregation|PROCEDURE: wound dressing with VAC|DRUG: wound dressing with VAC and sNAG under Antiaggregation

Number of Participants with Adverse Events as a Measure of Safety and Tolerability, up to 1 year|Wound surface area increase, respectively decrease as a measure of the effect of the studied devices on pressure ulcer healing, up to 1 year

Wound Healing characteristics, Evaluation of granulation tissue formation in study groups, up to 1 year|Wound Healing characteristics, Evaluation of wound epithelialization in study groups, up to 1 year|Wound Healing characteristics, Evaluation of wound contraction in study groups, up to 1 year

University Hospital, Basel, Switzerland

Marine Polymer Technologies, Inc.

ALL

ADULT, OLDER_ADULT

EARLY_PHASE1

OTHER

INTERVENTIONAL

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

2010-MD-0007

2011-02

2012-08

2012-08

2014-09-11

2015-09-29

University Hospital Basel, Basel, 4031, Switzerland|Swiss Paraplegic Centre Nottwil, Nottwil, 6207, Switzerland

{ "wound dressing with VAC and sNAG without antiaggregation": [ { "intervention_type": "OTHER" } ], "wound dressing with VAC": [ { "intervention_type": "PROCEDURE" } ], "wound dressing with VAC and sNAG under Antiaggregation": [ { "intervention_type": "DRUG" } ] }

NCT02430987

Low Sexual Desire and Metabolic Syndrome

https://clinicaltrials.gov/study/NCT02430987

COMPLETED

Objective: To evaluate the prevalence of hypoactive sexual desire disorder (HSDD) in postmenopausal women diagnosed with metabolic syndrome (MS) and to compare it to that of a control group without MS. Design: Cross-sectional study. Setting: Two public tertiary hospitals in the state of São Paulo, Brazil. Population: Two-hundred ninety-one postmenopausal women between 40 and 65 years of age. Methods: Sexual function was evaluated using the Female Sexual Function Index (FSFI) questionnaire and DSM-IV-TR diagnostic criteria and was related to the diagnosis of MS, which was determined according to the guidelines defined by the Adult Treatment Panel (ATP III). Main outcome measures: Analysis of sexual function with emphasis on sexual desire (HSDD), the presence of MS and its components.

NO

Menopause|Metabolic Syndrome|Hypoactive Sexual Desire Disorder|Obesity|Sexual Dysfunction

DIAGNOSTIC_TEST: Female sexual function index questionnaire|DIAGNOSTIC_TEST: Evaluation of presence of metabolic syndrome|DIAGNOSTIC_TEST: Evaluation of the body mass index

application of questionnaire, application of questionnaire about sexuality and sexual function, 1 year

Body mass index, Evaluated the body mass index of all participants, 2 years|Metabolic syndrome, Evaluated the diagnosis of metabolic syndrome, 3 years

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE

40594814.4.0000.5479

2014-09

2018-04

2018-07

2015-04-30

2022-10-12

Rua Maria José Pomar, 322 Apartamento 172 C, São Paulo, 02436070, Brazil

{ "Female sexual function index questionnaire": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Evaluation of presence of metabolic syndrome": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Evaluation of the body mass index": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT02074787

Imaging of Adult Burn Injuries

https://clinicaltrials.gov/study/NCT02074787

UNKNOWN

Burn injuries are a common presentation to A&E in the UK (175,000 per year) of whom 13,000 require hospital admission. Treatment of a single burn can cost more than £63,000, and is ultimately dependent on the depth. Most burns are assessed by experienced clinicians within a few days of injury. Accurate evaluation of burn depth can be very difficult with the naked eye. Inaccuracy can lead to longer hospital stays, worse scarring and greater financial costs for the NHS. Where the burn depth (and the degree of damage to the underlying blood supply of the skin) is not clear by visual inspection, adjuncts may be used to aid clinical decision-making. Currently, the gold standard method of assessing skin blood flow in order to help burn specialists in their assessment of burn depth is Laser Doppler Imaging (LDI). However, LDI machines can be very large, slow to collect the images, and a single imaging unit costs roughly £50,000. Consequently their use is restricted to the assessment of small burns in compliant patients treated in specialist units. Thermal imaging (thermography) has evolved rapidly as a useful diagnostic tool in many medical disciplines. Previous studies have shown that there are significant changes in skin physiology (such as temperature and pigmentation) depending on the depth of the burn. Portable, high-resolution thermal cameras are now affordable, easy to use and can provide numerical results in under a second. Similarly, measurement of skin pigment levels can be achieved using portable devices such as the Spectrophotometric Intracutaneous analysis scope (SIAscope). The aim of this study is to determine if alternative measures such as thermography or SIAscope can be as useful in the assessment of adult burns as LDI currently is. If this study demonstrates this then these results will inform further studies that would investigate these alternative imaging methods as a diagnostic and prognostic tool in the management of burns not only in adults but also in children presenting to non-specialised units such as A&E.

NO

Thermography|Laser Doppler Blood Flow|Spectrophotometric Intracutaneous Analysis

DEVICE: Thermography|DEVICE: Laser Doppler|DEVICE: Spectrophotometric Intracutaneous analysis

95% healing, The time to 95% epithelial healing of adult burn injuries as assessed by experienced burns clinicians, within 4 weeks of presentation

Chelsea and Westminster NHS Foundation Trust

Royal College of Surgeons of England

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

C&W13/090|14/EE/0048|141406

2014-03

2014-05

2014-09

2014-02-28

2014-02-28

Chelsea & Westminster NHS Foundation Trust, London, SW10 9NS, United Kingdom

{ "Thermography": [ { "intervention_type": "DEVICE" } ], "Laser Doppler": [ { "intervention_type": "DEVICE" } ], "Spectrophotometric Intracutaneous analysis": [ { "intervention_type": "DEVICE" } ] }

NCT01626287

Reduction of Perineal Pain After Vaginal Birth With Black Tea: Pilot Randomized Study

https://clinicaltrials.gov/study/NCT01626287

COMPLETED

Perineal trauma is common during vaginal birth. The discomfort this causes can interfere with a womans recovery and early motherhood.Mothers are offered a standard treatment after childbirth, water soaked frozen peri pads (ice packs), to alleviate the discomfort. However, a Cochrane review questions the efficacy of ice packs treatment. An alternative treatment that may be more comfortable and effective for women is warm water soaked black tea bags. Medicinal use of black tea bags has been based on their astringent (shrinking or constricting) properties and have been used for various medical applications. The investigators will conduct a pilot randomized controlled trial (RCT) of 40 pregnant mothers randomized to either intervention group (tea bags; n=20) or control group (ice packs; n=20). The goal of this pilot is to test the feasibility of a larger RCT by assessing recruitment, testing the protocol, and evaluating a proposed primary outcome objective of analgesic use during hospitalization as an indicator of pain. The investigators expect this pilot study to demonstrate feasibility for a large scale RCT to formally evaluate the efficacy of black tea bags to reduce perineal pain in this patient population.

NO

Perineal Pain

OTHER: Frozen perineal pad|OTHER: Warm water soaked Black Tea Bags

use of analgesia during hospitalization, 24 hours post partum

Fraser Health

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

FHREB 2012-044

2012-11

2013-05

2013-05

2012-06-22

2015-05-25

Abbotsford Regional Hospital and Cancer Centre, Abbotsford, British Columbia, Canada

{ "Frozen perineal pad": [ { "intervention_type": "OTHER" } ], "Warm water soaked Black Tea Bags": [ { "intervention_type": "OTHER" } ] }

NCT04076787

Clinical Outcomes for Patients With Renal Cell Carcinoma Who Received First-Line Sunitinib

https://clinicaltrials.gov/study/NCT04076787

COMPLETED

This is a retrospective, longitudinal cohort study that assessed clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib as first-line treatment.

YES

Metastatic Renal Cell Carcinoma

DRUG: Sunitinib

Overall Survival, Overall survival was defined as the time between index date and death due to any cause or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy., 60 months|Time to First-Line Sunitinib Treatment Discontinuation, Time to treatment discontinuation was defined as the time between index date and either discontinuation of first-line sunitinib therapy due to any reason including disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability. The index date was defined as the date of initiation of first-line sunitinib therapy., 60 months|Number of Participants Who Discontinued First-Line Sunitinib Treatment, In this outcome measure, participants who discontinued treatment due to any reason like disease progression, death, toxicity, both disease progression and toxicity, other or end of data availability are reported., 60 months|Percentage of Participants With Objective Response (OR), Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non target). Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters., 60 months|Percentage of Participants With Progressive Disease, Progressive disease (PD) was defined as an increase in visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. This includes the baseline sum if that is the smallest on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression., 60 months|Percentage of Participants With Stable Disease, Stable disease was defined as no change in size of visible disease. According to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), stable disease neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Progressive disease: - at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on the study. PR are those with at least 30 percent (%) decrease in the sum of diameters of the target lesions taking as a reference the baseline sum diameters., 60 months

Pfizer

International Metastatic Renal Cell Carcinoma Database Consortium (IMDC)|Analysis Group

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

A6181229

2018-09-01

2018-09-02

2018-09-02

2019-09-03

2019-10-10

2023-04-06

University of Calgary, Calgary, Alberta, P2N4N2, Canada

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/87/NCT04076787/Prot_SAP_000.pdf

{ "Sunitinib": [ { "intervention_type": "DRUG", "description": "Sunitinib", "name": "Sunitinib", "synonyms": [ "SU11248", "Sunitinib", "5-(5-Fluoro-2-oxo-1,2-dihydroindolylidenemethyl)-2,4-dimethyl-1H-pyrrole-3-carboxylic acid (2-diethylaminoethyl)amide", "SU 011248", "SU-11248", "Sunitinib Malate", "Sunitinibum", "SU011248", "SU-011248", "Sutent", "SU 11248" ], "medline_plus_id": "a607052", "generic_names": [ "Sunitinib" ], "mesh_id": "D047428", "drugbank_id": "DB01268" } ] }

NCT00703287

Specialized Physiotherapy Program for Cervical Dystonia

https://clinicaltrials.gov/study/NCT00703287

COMPLETED

The investigators wish to establish on a small scale the effectiveness of adding the physiotherapy programme developed by Jean-Pierre Bleton to the present standard treatment for cervical dystonia with a view to undertaking a larger UK-wide trial looking at overall cost-effectiveness. Specifically, the investigators wish to establish: 1. Whether this specific physiotherapy program for cervical dystonia improves patient outcomes in terms of neck position, pain, disability, and quality of life compared to simple physiotherapy advice? 2. What is the minimal clinically important change in the new CDIP-58 quality of life measure for cervical dystonia from a patients perspective that could then be used to plan a definitive trial of this technique? 3. What are the economic implications of the specialized physiotherapy programme?

NO

Cervical Dystonia

OTHER: Physiotherapy|OTHER: Physiotherapy

To compare different types of physiotherapy for treating condition, Review at 1 month, 3 months & 12 months

Dr Donald Grosset

University of Aberdeen

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

SN07NE039

2008-01

2010-05

2010-12

2008-06-23

2013-02-04

Southern General Hospital, 1345 Govan Road, Glasgow, Scotland, G51 4TF, United Kingdom

{ "Physiotherapy": [ { "intervention_type": "OTHER" }, { "intervention_type": "OTHER" } ] }

NCT00954187

Comparison of Oral Gabapentin and Pregabalin in Postoperative Pain Control After Photorefractive Keratectomy

https://clinicaltrials.gov/study/NCT00954187

TERMINATED

Purpose: To compare the efficacy of oral gabapentin and its newer analogue pregabalin in postoperative pain control after photorefractive keratectomy (PRK). Methods: One hundred and four patients who meet the inclusion criteria undergoing PRK in one or both eyes will be randomized into one of two treatment groups. Those in group A will be treated with gabapentin, and those in group B will be treated with pregabalin to control postoperative PRK pain. Patients in both groups will begin treatment two hours prior to surgery in order to achieve therapeutic blood levels of each medication. After surgery the patients will assess their pain level using the visual analogue scale (VAS) at different intervals of time - one hour after surgery, the evening of the surgery, and three times each day for three subsequent days. Patients will also daily assess their level of somnolence using the Epworth Sleepiness Scale (ESS) and record the presence of dizziness for the same amount of time. On the fourth day they will return to clinic for a postoperative appointment. At that time the pain, sleepiness, and dizziness assessment scales will be collected and analyzed. The patients will return one month later to further assess long-term pain and healing after PRK. Results: Both gabapentin and pregabalin have been shown in previous studies to treat postoperative pain effectively. The effects of gabapentin 300 mg TID for 3 days versus pregabalin 50 mg TID for 3 days on decreasing overall postoperative pain following PRK will be presented. Conclusion: The effectiveness of the two different treatment medications will be analyzed, and the conclusion will be based on the results.

YES

Postoperative Pain

DRUG: Gabapentin|DRUG: pregabalin

Decreased Overall Pain Score as Measured by the Visual Analogue Scale, No data was collected or analyzed. No study procedures were performed., one month

Loma Linda University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

59070

2009-11

2012-09

2013-04

2009-08-07

2014-09-25

2017-01-09

Loma Linda University - Ophthalmology, Loma Linda, California, 92354, United States

{ "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" } ], "Pregabalin": [ { "intervention_type": "DRUG", "description": "pregabalin", "name": "Pregabalin", "synonyms": [ "(S)-3-(aminomethyl)-5-methylhexanoic acid", "(S)-3-Isobutyl GABA", "(S+)-3-isobutyl GABA", "Axalid", "Pregabalin", "3 isobutyl GABA", "3-isobutyl GABA", "CI1008", "CI 1008", "3-(aminomethyl)-5-methylhexanoic acid", "3-Isobutyl GABA", "Pregabalina", "(R-)-3-isobutyl GABA", "1008, CI", "Lyrica", "CI-1008", "GABA, 3-isobutyl", "Alzain" ], "medline_plus_id": "a605045", "generic_names": [ "Pregabalin" ], "nhs_url": "https://www.nhs.uk/medicines/pregabalin", "mesh_id": "D014151", "drugbank_id": "DB00230", "wikipedia_url": "https://en.wikipedia.org/wiki/Pregabalin" } ] }

NCT00751387

Study Evaluating Epidemiology of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis in Australia

https://clinicaltrials.gov/study/NCT00751387

COMPLETED

The study is a cross sectional, epidemiology study of disease severity for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis in four geographic regions in Australia (Illawarra, Sutherland, Hunter Urban and Hunter Rural).

NO

Ankylosing Spondylitis|Psoriatic Arthritis|Rheumatoid Arthritis

Proportion of rheumatoid arthritis/psoriatic arthritis/ankylosing spondylitis patients in defined disease severity categories, Single visit

Proportion of patients exposed to biological disease modifying antirheumatic drugs, Single visit

Wyeth is now a wholly owned subsidiary of Pfizer

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

0881X1-4519|B1801088

2008-11

2009-09

2009-09

2008-09-12

2010-11-30

Georgetown, 2298, Australia|Miranda, 2228, Australia|Newcastle, 2300, Australia|Wollongong, 2500, Australia

{}

NCT00821587

Cyclosporine in Hepatitis C Infection Viral Clearance Following Liver Transplantation

https://clinicaltrials.gov/study/NCT00821587

COMPLETED

The purpose of this study is to evaluate the effect of cyclosporine, an anti-rejection drug, on the clearance of the hepatitis C virus in liver transplant subjects being treated with peg-interferon and ribavirin.

YES

Hepatitis C

DRUG: Cyclosporine|DRUG: Tacrolimus

Number of Participants With Less Than 100 Hepatitis C Virus RNA Copies/mL, Number of Participants with Undetectable or Less than 100 copies/ml Hepatitis C Viral Level --defined as SVR -Sustained Virologic Response, 6 months after completion of interferon based therapy

University of Florida

Novartis Pharmaceuticals

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

20040658

2004-06

2008-05

2008-05

2009-01-13

2011-12-08

2023-06-01

{ "Cyclosporine": [ { "intervention_type": "DRUG", "description": "Cyclosporine", "name": "Cyclosporine", "synonyms": [ "Cyclosporine", "CsA-Neoral", "Ciclosporine", "CyA NOF", "Ciclosporina", "Sandimmune", "Ciclosporin", "Cequa", "OL 27 400", "CsA Neoral", "CsANeoral", "OL 27-400", "Cyclosporin", "Cyclosporin A", "Gengraf", "Sandimmun", "OL 27400", "CsA", "CyA-NOF", "Ciclosporinum", "Restasis", "Cyclosporine A", "Sandimmun Neoral", "CyA", "Neoral" ], "medline_plus_id": "a604009", "generic_names": [ "Cyclosporine" ], "mesh_id": "D065095", "drugbank_id": "DB00091", "wikipedia_url": "https://en.wikipedia.org/wiki/Ciclosporin" } ], "Tacrolimus": [ { "intervention_type": "DRUG", "description": "Tacrolimus", "name": "Tacrolimus", "synonyms": [ "Anhydrous Tacrolimus", "Tacrolimus, anhydrous", "FR900506", "Astagraf XL", "FR 900506", "Tacrolimus", "Prograft", "FK506", "Anhydrous, Tacrolimus", "FR-900506", "Advagraf", "Tacrolimus Anhydrous", "Protopic", "Prograf", "FK-506", "Tacrolimus, Anhydrous", "Anhydrous tacrolimus", "FK 506", "Tacrolimus anhydrous" ], "medline_plus_id": "a602020", "generic_names": [ "Tacrolimus" ], "mesh_id": "D065095", "drugbank_id": "DB00864", "wikipedia_url": "https://en.wikipedia.org/wiki/Tacrolimus" } ] }

NCT05517187

Efficacy of Regenerative Endodontic Treatment With PRF as a Secondary Treatment of Mature Necrotic Incisors in Adolescents

https://clinicaltrials.gov/study/NCT05517187

PRF

RECRUITING

Evalaution of clinical success of secondary treatment for total 40 permanent incisors with failed root canal treatment with apical radiolucency. Twenty of of these permanent incisors will be treated with regenerative endodontic treatment(RET) with platelets rich fibrin PRF as intervention group vs. 20 incisors control group secondary treated with (RET) with induced blood clot (BC).

NO

Dental Pulp Necroses

OTHER: no intervention|BIOLOGICAL: Platelet rich fibrin

Clinical success, Clinical assessment will be performed at the baseline (T0) and after 12 months (T1). Upon examination, clinical failure will be encountered if one of the following features will present: (i) pain on biting or percussion, (ii) swelling or sinus tract, or (iii) abnormal tooth mobility., 12 months|Radiographic success, For a standardized appraisal of the changes in the size of periapical radiolucency, long cone paralleling technique with a receptor holder was used after mounting a size II periapical film (Kodak International) to a silicone bite stent., 12 months

Pulp sensibility test, In the control and intervention groups, the pulp sensations will be tested with an electric pulp tester (EPT) (Pulp Tester DY 310, Denjoy Dental Co.) at T1 and T2., 12 months

Nahda University

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

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

284

2022-03-10

2023-03-01

2023-03-01

2022-08-26

2022-08-31

Nahda University, Banī Suwayf, Egypt|Nahda, Cairo, Egypt

{ "no intervention": [ { "intervention_type": "OTHER" } ], "Platelet rich fibrin": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT01797887

Ayurvedic Versus Conventional Counseling in Mothers With Burnout-Syndrome

https://clinicaltrials.gov/study/NCT01797887

VEDA

COMPLETED

Aim of this study is to evaluate the effectiveness of Ayurvedic diet and lifestyle counseling compared to conventional standard diet and lifestyle counseling in outpatient mothers with burnout-syndrome.

NO

Burnout-Syndrome

BEHAVIORAL: Diet and Lifestyle Counseling

Maslach-Burnout-Inventory (MBI), 3 month

Maslach-Burnout-Inventory (MBI), 6 month|Cohen Perceived Stress Scale (CPSS), 3 and 6 month|Hospital Anxiety and Depression Scale (HADS-D), 3 and 6 month|SF-36, 3 and 6 month|Aspects of Spirituality (ASP), 3 and 6 month|Pittsburgh Sleep Quality Index (PSQI), 3 and 6 month

Qualitative Interviews, 6 month

Charite University, Berlin, Germany

Karl and Veronica Carstens Foundation|European Association for Ayurveda Therapists, Germany (VEAT)

FEMALE

ADULT

OTHER

INTERVENTIONAL

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

VEDA-Trial

2013-05

2014-12

2014-12

2013-02-25

2014-12-24

Immanuel Hospital Berlin, Berlin, 14109, Germany

{ "Diet and Lifestyle Counseling": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00833287

Immunoregulatory Dysfunction in Trauma Patients: Role of Obesity

https://clinicaltrials.gov/study/NCT00833287

ObesityRole

TERMINATED

Patient who have major traumatic injury are at risk to develop postoperative inflammatory complications such as pneumonia and lung trouble called adult respiratory distress syndrome (ARDS). This study will draw blood from trauma patients are several time points after their injury to see if we can predict who is at greatest risk for developing pneumonia or ARDS based upon the results of these immune lab tests. We are particularly interested to see if this will be useful in obese patients who have a greater risk of these post trauma complications

NO

Trauma|Obesity

University of Mississippi Medical Center

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2008-0126

2008-11

2011-03

2011-03

2009-02-02

2012-04-06

{}

NCT04111887

Pilot Study Comparing Two Versions of Group Cognitive-behavioral Indicated Prevention Programs

https://clinicaltrials.gov/study/NCT04111887

COMPLETED

The purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. Participants may experience reductions in depressive symptoms and prevention of future depression.

NO

Depressive Symptoms

BEHAVIORAL: Group-based therapy

Change from baseline Depressive Disorder Diagnostic using the Kiddie Schedule for Affective Disorders and Schizophrenia at 6 weeks, 3 months and 6 months, Evaluate change (if any) by using the Kiddie Schedule for Affective Disorders and Schizophrenia at the 6 week, 3 month and 6 month marks., Measured at baseline, 6 weeks, 3 months and 6 months|Difference in attendance in Change Ahead vs Blues Program groups using group leader notes, Evaluate difference (if any) in attendance in Change Ahead vs Blues Program group therapies by using group leader notes., Measured at each group therapy session (6 weeks in total).|Difference in future onset of Major Depressive Disorder using the Kiddie Schedule for Affective Disorders and Schizophrenia, Evaluate difference (if any) in the future onset of Major Depressive Disorder at 3 months and 6 months., Measured at baseline, 6 weeks, 3 months and 6 months.

Activity level, Evaluate the participants activity levels using Ecological Momentary Assessments (EMAs)., Measured at baseline, weeks 2,4 and 6.|Emotions, Evaluate the participants emotions using Ecological Momentary Assessments (EMAs)., Measured at baseline, weeks 2,4 and 6.|Positive and negative thoughts, Evaluate the participants positive and negative thoughts using Ecological Momentary Assessments (EMAs)., Measured at baseline, weeks 2,4 and 6.|Assessments using writing samples, Evaluate difference (if any) in social and academic problem solving skills and thoughts of the future., Measured at baseline and 6 weeks|Depression and anxiety symptoms using the PHQ-9, Evaluate difference (if any) in self-reported depression and anxiety symptoms, Measured at baseline, 6 weeks, 3 months and 6 months|Depression and anxiety symptoms using the GAD-7, Evaluate difference (if any) in self-reported depression and anxiety symptoms, Measured at baseline, 6 weeks, 3 months and 6 months|Social adjustment in school, work, peer, spare time, and family domains, Evaluate difference (if any) in self-reported social adjustment using 17 items adapted from Social Adjustment Scale-Self Report for Youth (Weissman, Orvaschel, & Padian, 1980), Measured at baseline, 6 weeks, 3 months and 6 months|Negative life events, Evaluate difference (if any) in self-reported negative life events, Measured at baseline|Health care utilization, Evaluate difference (if any) in self-reported utilization of health care services for physical health problems/injuries, mental health problems, and other personal problems., Measured at baseline, 6 weeks, 3 months and 6 months|Negative automatic thoughts, Evaluate difference (if any) in self-reported negative automatic cognition using 12 items from the Automatic Thoughts Questionnaire (ATQ; Hollon & Kendall, 1980), Measured at baseline, 6 weeks, 3 months and 6 months|Negative attributional style, Evaluate difference (if any) in self-reported negative attributional style, Measured at baseline, 6 weeks, 3 months and 6 months|Substance use, Evaluate difference (in any) in self-reported substance use using 10 items from Stice, Barrera and Chassin (1998). Participants report the frequency of intake of beer/wine/wine coolers and hard liquor, frequency of heavy drinking (5 or more drinks in a row), frequency of times drunk, and frequency of marijuana, stimulants, downers, inhalants, and hallucinogen use., Measured at baseline (in intake screener), 6 weeks, 3 months and 6 months

Oregon Research Institute

ALL

ADULT

OTHER

INTERVENTIONAL

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

Change Ahead

2017-10-10

2018-12-13

2018-12-13

2019-10-01

2020-09-16

Oregon Research Institute, Eugene, Oregon, 97401, United States

{ "Group-based therapy": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02241187

Two Stage Study Of Single Dose PEGPH20 And Cetuximab In Patients With Pancreatic Adenocarcinoma Prior To Surgical Resection

https://clinicaltrials.gov/study/NCT02241187

COMPLETED

This study has several purposes. DCE-MRI will be used to image the tumor. Safety of cetuximab given before surgery will be studied. Cetuximab delivery to the tumor will be studied. In Stage 2 of this study, the safety of cetuximab and PEGPH20 given before surgery will be studied. Also, the effects of PEGPH20 on tumors will be studied.

YES

Pancreatic Cancer

DRUG: PEGPH20|DRUG: Cetuximab|DEVICE: DW & DCE-MRI|OTHER: blood draws

Effects of PEGPH20, administration on resectable pancreatic adenocarcinoma tumors. DW- and DCE-MRI and distribution of cetuximab will be used to study tumor permeability to small and larger molecules, respectively. Resected tumors will be carefully studied for evidence of stromal degradation., 1 year

Safety of Administration of PEGPH20 and Cetuximab, in close proximity to surgical resection of pancreatic adenocarcinoma. Safety with regards to operative and post-operative complications will be characterized., 1 year

Memorial Sloan Kettering Cancer Center

Cold Spring Harbor Laboratory|Weizmann Institute of Science

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

14-039

2014-09-12

2016-09-13

2016-09-13

2014-09-16

2017-09-27

2017-09-27

Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States

{ "PEGPH20": [ { "intervention_type": "DRUG" } ], "Cetuximab": [ { "intervention_type": "DRUG", "description": "Cetuximab", "name": "Cetuximab", "synonyms": [ "Erbitux", "C\u00e9tuximab", "Cetuximab", "IMC-C225", "Cetuximabum", "IMC C225", "C225", "MAb C225" ], "medline_plus_id": "a607041", "generic_names": [ "Cetuximab" ], "mesh_id": "D000074322", "drugbank_id": "DB00002", "wikipedia_url": "https://en.wikipedia.org/wiki/Cetuximab" } ], "DW & DCE-MRI": [ { "intervention_type": "DEVICE" } ], "blood draws": [ { "intervention_type": "OTHER" } ] }

NCT05638087

Dexamethasone Treatment for OSA in Children

https://clinicaltrials.gov/study/NCT05638087

RECRUITING

This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.

NO

Obstructive Sleep Apnea

DRUG: Dexamethasone|DRUG: Placebo Control

Obstructive apnea-hypopnea index, Change in obstructive apnea-hypopnea index from baseline. The paediatric OSA severity scoring criteria will be used for all participants. Mild OSA is defined as OAHI ≥1 to <5 events/hr; moderate OSA is defined as OAHI ≥5 to <10 events/hr; and severe OSA is defined as OAHI ≥10 events/hr, Baseline and 2-4 weeks

Change in scores from baseline of the Child Sleep Habits Questionnaire (CSHQ) total score, Total CSHQ score of 41 has been reported to be a sensitive clinical cut-off point for detecting possible sleep problems, Baseline and 2-4 weeks|Change in scores from baseline of the Strengths and Difficulties Questionnaire (SDQ), The SDQ is a validated parent-reported behavioural screening questionnaire and is used to assess childrens mental health. The total difficulties score ranges from 0 to 40, a higher score indicates higher difficulties., Baseline and 2-4 weeks|Change in scores from baseline of the Obstructive Sleep Apnea-18 Quality of Life (OSA-18 QoL) Survey., The OSA-18 QoL survey is a validated 18-item quality of life measure for children with sleep-disordered breathing (SDB) for children 2-18. Higher total scores indicate more impact on QoL - minor impact (scores below 60), moderate impact (scores between 60 and 80) and major impact (scores above 80)., Baseline and 2-4 weeks|Soft tissue size (Adenoids, Tonsils & Turbinates), Change in soft tissue size (adenoids, tonsils and turbinates) from baseline, Baseline and 2-4 weeks|Cytokine levels of Interleukin-8(IL-8), Interleukin-1b(IL1b), and Tumor Necrosis Factor a (TNFa) at baseline, Inflammatory markers will be measured in basal media of cells cultured from nasal brushing by ELISA, At baseline|Inflammatory gene expression of Interleukin-8, Interleukin-1b, Nuclear factor kappa-B (NF-kB) and Tumor Necrosis Factor a (TNFa), Cells from nasal brushing will be cultured and harvested for RNA to study gene expression., At baseline|Participant recruitment rate, Feasibility determined by participant recruitment rate, From study start to completion; up to 6 months|Participant retention rate, Feasibility determined by participant retention rate, From study start to completion; up to 6 months|Participant adherence rate, Feasibility determined by participant adherence rate, From study start to completion; up to 6 months|Adverse events, Safety determined by number and severity of adverse events, From study start to completion; up to 6 months

The Hospital for Sick Children

ALL

CHILD

PHASE3

OTHER

INTERVENTIONAL

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

1000079288

2022-10-26

2024-06-30

2024-06-30

2022-12-06

2024-01-17

The Hospital for Sick Children, Toronto, Ontario, M5V 1X8, Canada

{ "Dexamethasone": [ { "intervention_type": "DRUG", "description": "Dexamethasone", "name": "Dexamethasone", "synonyms": [ "Millicorten", "1-Dehydro-16\u03b1-methyl-9\u03b1-fluorohydrocortisone", "Dextenza", "Decaject-L.A.", "Cortidex", "Dexpak", "Dexam\u00e9thasone", "Dexasone", "Decameth", "Dexametasona", "Methylfluorprednisolone", "Decadron", "Martapan", "Decaspray", "16\u03b1-Methyl-9\u03b1-fluoro-1-dehydrocortisol", "Dexamethasone", "Decaject", "Ozurdex", "16alpha-Methyl-9alpha-fluoro-1-dehydrocortisol", "Decaject L.A.", "TobraDex", "Maxidex", "Hexadrol", "Dexair", "Dexamethasonum", "Dexacidin", "Oradexon", "Hexadecadrol", "Glensoludex", "Neofordex", "Maxitrol", "1-Dehydro-16alpha-methyl-9alpha-fluorohydrocortisone", "9\u03b1-Fluoro-16\u03b1-methylprednisolone", "9alpha-Fluoro-16alpha-methylprednisolone", "Maxidex", "Dexamethasone eye drops", "Eythalm", "Dexafree", "Dropodex", "Maxidex", "Dexamethasone eye drops", "Eythalm", "Dexafree", "Dropodex" ], "medline_plus_id": "a682869", "generic_names": [ "Dexamethasone" ], "nhs_url": "https://www.nhs.uk/medicines/dexamethasone-tablets-and-liquid", "mesh_id": "D018931", "drugbank_id": "DB01234", "wikipedia_url": "https://en.wikipedia.org/wiki/Dexamethasone" } ], "Placebo Control": [ { "intervention_type": "DRUG" } ] }

NCT03404687

Risk of Malignancy Index and Assiut Scoring Model for Adnexal Malignancy

https://clinicaltrials.gov/study/NCT03404687

COMPLETED

The presence of an adnexal mass is a frequent reason for a woman to be referred to a gynaecologist. The discrimination between benign and malignant adnexal masses is central to decisions regarding clinical management and surgical planning in such patients. Patients with malignant tumours should be referred to a gynaecological oncologist, as the quality of cytoreductive surgery and surgical staging/lymph node dissection are important prognostic factors in ovarian cancer. These specialized surgical procedures require the specific skills and experience provided by gynaecologic oncology surgeons. Furthermore, appropriate and timely referral to a gynaecologic oncologist has been proven to increase survival in patients with ovarian cancer.Conversely, patients believed to have a benign mass requiring surgery are able to have this performed by a general gynaecologist. A standardized method for preoperative identification of probable malignant masses would allow optimization of first-line treatment for women with ovarian cancer. A risk of malignancy index would be valuable for the selective referral of relevant patients to specialized oncology centres. Currently, clinical examination, ultrasound assessment, and assays of tumour markers are part of the standard work-up for an adnexal mass. Although none of these indicators alone is very sensitive or specific for detecting malignancy, an index developed by Jacobs et al. incorporates information about the patients menopausal status and serum Cancer antigen A-125 levels, and ultrasound characteristics of the mass to predict the risk of malignancy with greater sensitivity and specificity than any one factor alone.Some of the potential advantages of risk malignant index include rapid triage of patients through the referral system and fewer operations for benign masses being performed by gynaecologic oncologists.

NO

Risk Malignant Index

RADIATION: ultrasound|DIAGNOSTIC_TEST: cancer antigen 125 level|RADIATION: Doppler

Number of women has a malignant adnexal mass, 7 days

Assiut University

FEMALE

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RMI_ASS

2016-01-01

2017-12-01

2018-01-01

2018-01-19

2018-01-19

Women Health Hospital - Assiut university, Assiut, 71111, Egypt

{ "ultrasound": [ { "intervention_type": "RADIATION" } ], "cancer antigen 125 level": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Doppler": [ { "intervention_type": "RADIATION" } ] }

NCT05671887

DREAM: Double Lung Transplant REgistry Aimed for Lung-limited Malignancies

https://clinicaltrials.gov/study/NCT05671887

DREAM

RECRUITING

This is a prospective observational registration trial for patients who undergo lung transplantation for the treatment of the select groups of medically refractory cancers affecting the lungs alone without extrapulmonary nodal and distant metastasis.

NO

Lung Cancer|Bilateral Cancer|Lung Transplant

PROCEDURE: Double Lung Transplantation

overall survival (OS) rate, 30-day|overall survival (OS) rate, 90-day|disease-free survival (DFS) rate, 30-day|disease-free survival (DFS) rate, 90-day|allograft rejection (AR) rate, 30-day|allograft rejection (AR) rate, 90-day|allograft survival (AS) rate, 30-day|allograft survival (AS) rate, 90-day

overall survival (OS) rate, 6-month, 1-year, 3-year, and 5-year|disease-free survival (DFS) rate, 6-month, 1-year, 3-year, and 5-year|allograft rejection (AR) rate, 6-month, 1-year, 3-year, and 5-year|allograft survival (AS) rate, 6-month, 1-year, 3-year, and 5-year|Major post-transplantation morbidity (MPTM), including acute kidney failure requiring continuous renal replacement therapy, 6-month, 1-year, 3-year, and 5-year

Northwestern University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

STU00217958|NU 22L02

2022-11-16

2032-11

2032-11

2023-01-05

2023-09-25

Thoracic Surgery, Canning Thoracic Institute (Northwestern Memorial Hospital), Chicago, Illinois, 60611, United States

{ "Double Lung Transplantation": [ { "intervention_type": "PROCEDURE" } ] }

NCT00640887

Pharmacokinetics of Rifabutin Combined With Antiretroviral Therapy in Patients With TB/HIV Co-infection in South Africa

https://clinicaltrials.gov/study/NCT00640887

COMPLETED

The overall aim of the project is to evaluate rifabutin (RBT) as a replacement for rifampicin (RMP), for the combined treatment of tuberculosis and HIV infection. RBT represents an alternative to RMP for HIV infected patients as its half-life is longer and the enzymatic induction effect appears to be less important on the associated antiretroviral therapy (ART) drugs. This phase II trial is to determine precisely the pharmacokinetics parameters of RBT in combination with different ART regimens in Vietnamese HIV infected patients with pulmonary tuberculosis, in order to define optimal doses that will be further tested in a larger phase III trial comparing safety, tolerability and efficacy of RBT and RMP regimens.

NO

HIV Infections|Tuberculosis

DRUG: rifabutin in combination with efavirenz|DRUG: rifabutin in combination with nevirapine|DRUG: rifabutin in combination with lopinavir/ritonavir

Area under the curve (AUC) of rifabutine measured (a)before introduction of ART;(b)after ART initiation (two different doses of RBT in combination with efavirenz, nevirapine or lopinavir/ritonavir), 2, 6 and 10 weeks after randomisation

Area under the curve (AUC) of efavirenz, nevirapine and lopinavir/ritonavir in combination with two doses of rifabutine, 6 and 10 weeks after randomisation|Safety : proportion of patients with grade 3 and grade 4 adverse events, through out the trial

French National Agency for Research on AIDS and Viral Hepatitis

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER_GOV

INTERVENTIONAL

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

ANRS12150a

2009-02

2010-10

2010-10

2008-03-21

2011-06-20

Unit for Clinical and Biomedical TB Research (Medical Research Council), Durban, 4067, South Africa

{ "Rifabutin": [ { "intervention_type": "DRUG", "description": "rifabutin in combination with efavirenz", "name": "Rifabutin", "synonyms": [ "Rifabutine", "LM427", "Alfacid", "Rifabutin", "4-N-isobutylspiropiperidylrifamycin S", "Mycobutin", "LM 427", "Ansatipine", "4-Deoxo-3,4-(2-spiro(N-isobutyl-4-piperidyl)-2,5-dihydro-1H-imidazo)-rifamycin S", "Ansamicin", "Ansamycin", "1,4-Dihydro-1-deoxy-1',4-didehydro-5'-(2-methylpropyl)-1-oxorifamycin XIV", "Ansatipin", "Rifabutina", "LM-427", "Rifabutinum" ], "medline_plus_id": "a693009", "generic_names": [ "Rifabutin" ], "mesh_id": "D000904", "drugbank_id": "DB00615" }, { "intervention_type": "DRUG", "description": "rifabutin in combination with nevirapine", "name": "Rifabutin", "synonyms": [ "Rifabutine", "LM427", "Alfacid", "Rifabutin", "4-N-isobutylspiropiperidylrifamycin S", "Mycobutin", "LM 427", "Ansatipine", "4-Deoxo-3,4-(2-spiro(N-isobutyl-4-piperidyl)-2,5-dihydro-1H-imidazo)-rifamycin S", "Ansamicin", "Ansamycin", "1,4-Dihydro-1-deoxy-1',4-didehydro-5'-(2-methylpropyl)-1-oxorifamycin XIV", "Ansatipin", "Rifabutina", "LM-427", "Rifabutinum" ], "medline_plus_id": "a693009", "generic_names": [ "Rifabutin" ], "mesh_id": "D000904", "drugbank_id": "DB00615" }, { "intervention_type": "DRUG", "description": "rifabutin in combination with lopinavir/ritonavir", "name": "Rifabutin", "synonyms": [ "Rifabutine", "LM427", "Alfacid", "Rifabutin", "4-N-isobutylspiropiperidylrifamycin S", "Mycobutin", "LM 427", "Ansatipine", "4-Deoxo-3,4-(2-spiro(N-isobutyl-4-piperidyl)-2,5-dihydro-1H-imidazo)-rifamycin S", "Ansamicin", "Ansamycin", "1,4-Dihydro-1-deoxy-1',4-didehydro-5'-(2-methylpropyl)-1-oxorifamycin XIV", "Ansatipin", "Rifabutina", "LM-427", "Rifabutinum" ], "medline_plus_id": "a693009", "generic_names": [ "Rifabutin" ], "mesh_id": "D000904", "drugbank_id": "DB00615" } ], "Efavirenz": [ { "intervention_type": "DRUG", "description": "rifabutin in combination with efavirenz", "name": "Efavirenz", "synonyms": [ "Sustiva", "Efavirenzum", "(S)-6-chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one", "Efavirenz", "(S)-6-chloro-4-(Cyclopropylethynyl)-1,4-dihydro-(S)-6-chloro-4-(cyclopropylethynyl)-1,4-dihydro-4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one4-(trifluoromethyl)-2H-3,1-benzoxazin-2-one", "6-chloro-4-(2-cyclopropyl-1-ethynyl)-4-trifluoromethyl-(4S)-1,4-dihydro-2H-benzo[d][1,3]oxazin-2-one", "\u00c9favirenz" ], "medline_plus_id": "a699004", "generic_names": [ "Efavirenz" ], "drugbank_id": "DB00625" } ], "Nevirapine": [ { "intervention_type": "DRUG", "description": "rifabutin in combination with nevirapine", "name": "Nevirapine", "synonyms": [ "Nevirapine Hemihydrate", "Nevirapina", "Hemihydrate, Nevirapine", "Nevirapine", "BIRG587", "11-cyclopropyl-5,11-dihydro-4-methyl-6H-dipyrido(3,2-b:2',3'-e)(1,4)diazepin-6-one", "Nevirapine anhydrous", "BI RG 587", "BI-RG-587", "Viramune", "Nevirapine, anhydrous", "NEV", "NVP" ], "medline_plus_id": "a600035", "generic_names": [ "Nevirapine" ], "mesh_id": "D065701", "drugbank_id": "DB00238" } ], "Lopinavir/ritonavir": [ { "intervention_type": "DRUG", "description": "rifabutin in combination with lopinavir/ritonavir", "name": "Lopinavir/ritonavir", "synonyms": [ "Kaletra", "Aluvia", "Lopinavir/ritonavir" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Lopinavir/ritonavir", "generic_names": [] } ] }

NCT03890887

A Study in Healthy Men to Test How Itraconazole Influences the Amount of BI 1291583 in the Blood

https://clinicaltrials.gov/study/NCT03890887

COMPLETED

The main objective of this trial is to investigate the relative bioavailability of BI 1291583 in plasma when given as oral single dose together with multiple oral doses of itraconazole (Test, T) as compared to when given alone as oral single dose (Reference, R).

NO

Healthy

DRUG: BI 1291583|DRUG: Itraconazole

Area under the concentration-time curve of BI 1291583 in plasma over the time interval from 0 to the last quantifiable data point, Up to 263 hours.|Maximum measured concentration of BI 1291583 in plasma, Up to 263 hours.

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity, Up to 263 hours.

Boehringer Ingelheim

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

1397-0010|2018-004214-17

2019-04-12

2019-07-29

2019-07-29

2019-03-26

2021-11-11

CRS Clinical Research Services Mannheim GmbH, Mannheim, 68167, Germany

{ "BI 1291583": [ { "intervention_type": "DRUG" } ], "Itraconazole": [ { "intervention_type": "DRUG", "description": "Itraconazole", "name": "Itraconazole", "synonyms": [ "3H-1,2,4-TRIAZOL-3-ONE, 4-(4-(4-(4-((2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-2,4-DIHYDRO-2-(1-METHYLPROPYL)-", "Orungal", "R 51211", "Sporanox", "R51211", "Itraconazol", "(\u00b1)-1-SEC-BUTYL-4-(P-(4-(P-(((2R*,4S*)-2-(2,4-DICHLOROPHENYL)-2-(1H-1,2,4-TRIAZOL-1-YLMETHYL)-1,3-DIOXOLAN-4-YL)METHOXY)PHENYL)-1-PIPERAZINYL)PHENYL)-.DELTA.(SUP 2)-1,2,4-TRIAZOLIN-5-ONE", "Oriconazole", "Onmel", "Itraconazole", "ITRACONAZOLE COMPONENT OF SUBA-ITRACONAZOLE", "R-51211", "Itraconazolum" ], "medline_plus_id": "a692049", "generic_names": [ "Itraconazole" ], "mesh_id": "D065692", "drugbank_id": "DB01167" } ] }

NCT05229887

Confirmation of Tube Placement in Newborns

https://clinicaltrials.gov/study/NCT05229887

WITHDRAWN

Tracheal intubation remains a common procedure in the neonatal intensive care unit (NICU) and the delivery room (DR). Current guidelines recommend Estimation of correct endotracheal tube (ETT) insertion Our hospital policy recommends to estimate the correct depth (cm) of tube placement by measuring the nasal-ear-tragus length using the 7-8-9 rule when the endotracheal tube is placed orally. Using this formula an infant weighing 1kg would be intubated to a depth of 7cm, a 2kg infant to a depth of 8cm, and a 3kg infant to a depth of 9cm from the upper lip. With the new 2015 guidelines, ETT depth is determined by measuring the newborns nasal septum-tragus length (NTL) and adding 1cm or by using the initial endotracheal tube insertion depth table. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear. However, studies using NTL reported that using this technique only resulted in correct ETT placement in 56% of cases. Every ETT has markings on the tube, which are called vocal cord markings, which are to be used to provide a guidance to how deep to place the ETT into the trachea. There has been npc study to compare the vocal cord markings with the current approach of NTL. The current study aims to determine if the use of vocal cord markings during intubation increases percentage of correct endotracheal tube placement compared to NTL in preterm and term infants.

NO

Respiratory Distress Syndrome|Apnea of Newborn

PROCEDURE: Nostril-Tragus-Length|PROCEDURE: Vocal cord marking

Number of endotracheal tubes correctly placed within the trachea, within 30 minutes after endotracheal intubation

Mortality in the Neonatal Intensive Care Unit, We will record the number of infants who die during their admission, 0-200 days|Necrotizing Enterocolitis, We will record the number of infants who are diagnosed with Necrotizing Enterocolitis, 0-200 days|Patent Ductus Arteriosus, We will record the number of infants who are diagnosed with Patent Ductus Arteriosus, 0-200 days|Intraventricular hemorrhage all grades, We will record the number of infants who are diagnosed with intraventricular hemorrhage, 0-200 days|Bronchopulmonary Dysplasia at, We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia, 36 weeks corrected gestational age|Changes in oxygen saturation during intubation procedure, During intubation we will record the lowest oxygen saturation, 0 to 60 seconds|Changes in Heart rate during intubation procedure, During intubation we will record the lowest heart rate., 0 to 60 seconds|Duration of Intubation procedure, During Intubation, we will measure time from end of mask ventilation to connection of the ventilation device to ETT, 0 to 60 seconds|Airway injury observed during intubation (including blood, swollen cords, vocal cord redness), Observed by the person who performs the intubation by looking for blood, swollen cords, redness. There is no score or questionnaire. The operator will only assess these with yes or no, 0 to 60 seconds

University of Alberta

ALL

CHILD

OTHER

INTERVENTIONAL

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

Pro00116201

2022-07-04

2024-12-31

2025-03-31

2022-02-08

2023-04-25

Royal Alexandra Hospital, Edmonton, Alberta, T5H 3V9, Canada

{ "Nostril-Tragus-Length": [ { "intervention_type": "PROCEDURE" } ], "Vocal cord marking": [ { "intervention_type": "PROCEDURE" } ] }

NCT04487587

A Phase II Clinical Trial of Cediranib and Olaparib Maintenance in Advanced Recurrent Cervical Cancer

https://clinicaltrials.gov/study/NCT04487587

COMICE

UNKNOWN

COMICE is a randomised, double blind placebo controlled Phase II trial. The trial is recruiting 108 patients with advanced recurrent cervical cancer who have completed their 1st line chemotherapy for advanced/recurrent disease. Patients will be randomised to either placebo Cediranib and Olaparib or active Cediranib and Olaparib and will remain on treatment until progression of disease, unacceptable toxicity or withdrawal of consent. Patients will be assessed for disease progression every 8 weeks through CT/MRI imaging. The primary end point is Progression Free Survival.

NO

Cervical Cancer

DRUG: Cediranib, Olaparib

Progression Free Survival, Date of disease progression *Current standard of care in this group of patients would be clinical follow up with no treatment, The study ends when the last patient recruited has completed a minimum of 7 months on study. Recruitment period is 14 months so the maximum time a patient will be on study for is 21 months

Rate of Toxicity, Safety (Toxicity, Serious Adverse Events), SAEs are reported from randomisation to 30 days following the last administration of study IMP|Quality of Life FACT-Cx, Functional Assessment of Cancer Therapy- Cervical Cancer questionnaire, completed at baseline then at the four weekly treatment review visit, up to the earlier of disease progression or 7 months|Overall Survival, Date of death, from randomisation until date of death from any cause, assessed up to 21 months|Tumour Response, Tumour Response using RECIST v1.1, from date of randomisation until the date of first documented disease progression, assessed up to 21 months

The Clatterbridge Cancer Centre NHS Foundation Trust

University of Liverpool

FEMALE

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

CCC844

2018-10-09

2021-08-01

2021-09-01

2020-07-27

2020-07-27

Clatterbridge Cancer Centre, Wirral, CH63 4JY, United Kingdom

{ "Olaparib": [ { "intervention_type": "DRUG", "description": "Cediranib, Olaparib", "name": "Olaparib", "synonyms": [ "Lynparza", "4-(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2H)-one", "Olaparib" ], "medline_plus_id": "a614060", "generic_names": [ "Olaparib" ], "drugbank_id": "DB09074", "wikipedia_url": "https://en.wikipedia.org/wiki/Olaparib" } ] }

NCT04093687

Towards Painless Colonoscopy

https://clinicaltrials.gov/study/NCT04093687

UNKNOWN

One of the major barriers to CRC screening participation is a negative perception of colonoscopy as a painful and unpleasant procedure. Previously, by monitoring patient-reported outcomes as one of the colonoscopy quality performance measures, the investigators identified the endoscopist as the single, most important risk factor for painful colonoscopy. Therefore, the investigators propose a randomized controlled trial to analyse the effectiveness of directed training on the endoscopists painful colonoscopy rate. The study will be conducted in two phases: endoscopist categorization and design of training (I) and randomized controlled trial evaluating training effectiveness (II). Phase I will include endoscopists from Polish Colonoscopy Screening Programme (PCSP) willing to participate. Volunteers will be divided into underperformers, average performers and overperformers, based on their painful colonoscopy rate (obtained from PCSP database records) and will be invited to take part in the initial workshop focused on pain reduction during colonoscopy (conducted in a similar fashion to Train Colonoscopy Leaders (TCL) workshop, aiming at ADR improvement). On the basis of the differences in performance between over- and underperformers, categories of importance, target scores and a questionnaire for the assessment of factors for improvement will be developed. In Phase II, endoscopists from PCSP screening centres previously categorized as underperformers and average performers will be randomized in 1:1 ratio either to control (no intervention) or intervention arm. The subjects in the control arm will not be trained or informed about study participation. The endoscopists assigned to the intervention arm will be invited to take part in one training session designed in Phase I of the study (according to the evaluation questionnaire from Phase I). Willing overperformers will be asked to participate in the training as teachers. The training session will be divided into two parts: theoretical - presentation of research on painless colonoscopy - and practical - colonoscopy performance with commentary. Subjects matched 1:1 with trainers will take part in such a session, supervised by the study coordinator. Each endoscopist who underwent training in the second phase of the study will be sent a written, customized feedback on changes after the intervention and information about factors to improve (as per evaluation questionnaire from Phase I of the study). All endoscopists enrolled into Phase II will be followed through PCSP database for the endpoint of painful colonoscopy rate; the intervention arm will be compared with the control group at 6 and 12 months after feedback in order to investigate whether the adjusted painful colonoscopy rate improved as a result of the intervention.

NO

Colorectal Cancer

OTHER: Endoscopists training

Endoscopist adjusted painful colonoscopy rate change, Endoscopist adjusted painful colonoscopy rate change (pain during colonoscopy) assessed 6 and 12 months after training intervention., assessed 6 and 12 months after training intervention

Endoscopist adjusted painful colonoscopy rate change - pain after colonoscopy, Endoscopist adjusted painful colonoscopy rate change (pain after colonoscopy) assessed 6 and 12 months after training intervention., assessed 6 and 12 months after training intervention|Adenoma detection rate (ADR), Adenoma detection rate - percentage of colonoscopies with at least one adenoma identified., assessed 6 and 12 months after training intervention|Cecum intubation rate (CIR), Percentage of colonoscopies with cecum reached., assessed 6 and 12 months after training intervention|Adjusted painful colonoscopy rate for screening centres (in which assessed endoscopists are working), Center adjusted painful colonoscopy rate change (pain during colonoscopy) assessed 6 and 12 months after training intervention., assessed 6 and 12 months after training intervention

Maria Sklodowska-Curie National Research Institute of Oncology

Centre of Postgraduate Medical Education

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SCREENING

MSCI

2019-11

2020-06

2021-07

2019-09-18

2019-09-18

Maria Sklodowska-Curie Institute - Oncology Center, Warsaw, Poland

{ "Endoscopists training": [ { "intervention_type": "OTHER" } ] }

NCT00603187

ACY-7 Oral Administration of Acyline

https://clinicaltrials.gov/study/NCT00603187

ACY-7

COMPLETED

We propose oral dosing of gastrointestinal permeation enhancement technology [GIPET] enhanced oral acyline at 20 mg everyday for one week to determine the steady-state (multiple-dose) pharmacokinetics of oral acyline in four normal, healthy young men.

YES

Healthy

DRUG: Acyline

Testosterone Blood Serum Concentration, Blood for measurement of serum testosterone was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose., 7 days

FSH Blood Serum Concentration, Blood for measurement of serum follicle stimulating hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose., 7 days|LH Blood Serum Concentration, Blood for measurement of serum leutenizing hormone concentrations was obtained prior to the 1st, 5th and 6th dose of GIPET™-enhanced oral acyline and 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 60 hours after the 7th dose., 7 days

University of Washington

Merrion Pharmaceuticals, LLC

MALE

ADULT

PHASE1|PHASE2

OTHER

INTERVENTIONAL

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

32716-W|07-7973-W

2008-01

2008-02

2008-02

2008-01-28

2011-06-09

2011-06-09

University of Washington, Seattle, Washington, 98195, United States

{ "Acyline": [ { "intervention_type": "DRUG", "description": "Acyline", "name": "Acyline", "synonyms": [ "", "Acyline" ], "drugbank_id": "DB11906", "generic_names": [ "Acyline" ] } ] }

NCT05647187

Effect Narrow-Band UVB Radiations

https://clinicaltrials.gov/study/NCT05647187

UVB

COMPLETED

Narrow-band UVR affects Interleukin 17 which has a major role in the pathogenesis of psoriasis Vulgaris. the aim of this study to evaluate the serum levels of Interleukin 17 in psoriatic patients and compare with the levels in healthy controls & evaluate the effect of narrow-band ultraviolet B (NB-UVB) on the serum of Interleukin 17 and the treatment of psoriasis Vulgaris.

NO

Psoriasis Vulgaris|UVB Phototherapy Burn

DIAGNOSTIC_TEST: Serum Interleukin 17 levels|RADIATION: NB-UVB

Primary (main):, To evaluate the clinical efficacy of narrow-band ultraviolet B (NB-UVB) in treatment of psoriasis vulgaris , evaluate serum levels of Interleukin 17 in psoriatic patients and compare them with levels in healthy controls, 12 weeks

Secondary (subsidiary), Response to treatment will be evaluated by photographing the patients and calculating psoriasis area and severity index (PASI) score at the baseline before starting the treatment and monthly after starting the treatment., 12 weeks

South Valley University

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

SVU.MED.DVA021, Code 1, N76

2020-01-01

2021-07-01

2021-10-01

2022-12-12

2022-12-12

South Valley University, Qinā, Qena, 83522, Egypt

{ "Serum Interleukin 17 levels": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "NB-UVB": [ { "intervention_type": "RADIATION" } ] }

NCT00542087

Etoricoxib vs. Diclofenac in OA (0663-805)(COMPLETED)

https://clinicaltrials.gov/study/NCT00542087

COMPLETED

To compare the safety and tolerability of etoricoxib and diclofenac sodium in the treatment of osteoarthritis of the knee or hip during a six week period.

NO

Osteoarthritis

DRUG: MK0663, etoricoxib / Duration of Treatment: 6 Weeks|DRUG: Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks

This study will assess the effectiveness of the study drug vs. a comparator to treat successfully OA-related joint pain (judged by WOMAC pain subscale).

The study drug will be safe and well tolerated during the course of the study.

Organon and Co

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

0663-805|2007_625

2002-03-22

2002-12-20

2002-12-20

2007-10-10

2022-02-18

{ "Etoricoxib": [ { "intervention_type": "DRUG", "description": "MK0663, etoricoxib / Duration of Treatment: 6 Weeks", "name": "Etoricoxib", "synonyms": [ "MK 0663", "\u00e9toricoxib", "Arcoxia", "L 791456", "Etoricoxibum", "MK-0663", "MK0663", "Etoricoxib", "5-chloro-2-(6-methylpyridin-3-yl)-3-(4-(methylsulfonyl)phenyl)pyridine", "L-791456", "5-chloro-6'-methyl-3-(p-(methylsulfonyl)phenyl)-2,3'-bipyridine", "5-Chloro-3-(4-methanesulfonyl-phenyl)-6'-methyl-[2,3']bipyridinyl", "L791456" ], "mesh_id": "D052246", "generic_names": [ "Etoricoxib" ], "drugbank_id": "DB01628" } ], "Diclofenac": [ { "intervention_type": "DRUG", "description": "Comparator: diclofenac sodium / Duration of Treatment: 6 Weeks", "name": "Diclofenac", "synonyms": [ "Diclofenacum", "Motifene", "Diclofenac, Sodium", "SR38", "Diclofenac", "Sodium Diclofenac", "SR-38", "Dicrofenac", "Zorvolex", "Orthophen", "2-((2,6-dichlorophenyl)amino)benzeneacetic acid", "Dicloflex", "SR 38", "Diclomax", "Ortofen", "Cambia", "Diclophenac", "GP 45,840", "Voltaren XR", "Voltarol", "Diclofenac Potassium", "GP45,840", "[2-(2,6-dichloroanilino)phenyl]acetic acid", "Feloran", "Fenactol", "Novapirina", "Voltaren", "Dichlofenal", "GP-45,840", "Diclofenac acid", "Diclonate P", "Orthofen", "Econac", "Diclofenaco", "Diclofenac Sodium" ], "medline_plus_id": "a606003", "generic_names": [ "Diclofenac" ], "nhs_url": "https://www.nhs.uk/medicines/diclofenac", "mesh_id": "D016861", "drugbank_id": "DB00586" } ] }

NCT03412487

Ovarian Histopathology and Laparoscopic Assessment of Premature Ovarian Failure

https://clinicaltrials.gov/study/NCT03412487

UNKNOWN

25 women with Premature Ovarian Failure who attended Fayoum university hospital gynecology outpatient clinic (case group) and another group of 25 women with normal ovarian function (control group). *Pelvic laparoscopy and ovarian biopsy will be done ovarian biopsy preparation For assessment of autoimmune oophoritis, sections were immunostained with anti-LCA (CD45) monoclonal antibody

NO

Premature Ovarian Failure

PROCEDURE: laparoscopy

presence of autoimuune oophoritis, Autoimmune oophritis was assessed by quantifying LCA positive cells in ovarian stroma as follows: [Type text] 0= not convincing. 1. mild autoimmune oophritis. 2. moderate autoimmune oophritis. 3. sever autoimmune oophritis., at time of laproscopy procedure

Cairo University

FEMALE

ADULT

OTHER

INTERVENTIONAL

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

21

2018-01

2018-12

2019-01

2018-01-26

2018-01-26

Kasr Alainy medical school, Cairo, 12151, Egypt

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

NCT02359487

Behavioral Counseling Intervention Trial to Reduce Alcohol-related Sexual Risk Behavior Among HIV-negative Men in Namibia

https://clinicaltrials.gov/study/NCT02359487

COMPLETED

The overall purpose of this study is to evaluate an intervention that aims to reduce alcohol-related HIV sexual risk behaviors among HIV-negative men in Namibia. The objectives of the study are to determine the effectiveness of an individual counseling intervention in reducing alcohol-related HIV sexual risk behaviors among men, and in reducing harmful and hazardous alcohol use among men.

NO

Alcohol Consumption|Alcohol Abuse|HIV|Sexual Behavior

BEHAVIORAL: Alcohol-HIV Risk Reduction Counseling|BEHAVIORAL: Placebo Intervention

Change in frequency of sex after drinking (measured by count data and proportions), Sex acts preceded by alcohol use, for up to 4 recent sex partners, measured by count data and proportions, 3 months, 6 months after intervention

Change in frequency of condom use (measured by count data and proportions), Sex acts protected by condoms, for up to 4 recent sex partners, measured by count data and proportions, 3 months, 6 months after intervention|Change in number of sex partners, Number of sex partners in preceding 6 months, 3 months, 6 months after intervention|Change in frequency of alcohol use (measured by AUDIT and CAGE screens), Quantity and frequency of alcohol use, measured by AUDIT and CAGE screens, 3 months, 6 months after intervention|Change in condom skills (measured by a condom use demonstration score, modified 9-item male condom use score (MCUS), Changes in condom skills, as measured by a condom use demonstration score, 3 months, 6 months after intervention

Centers for Disease Control and Prevention

MALE

ADULT, OLDER_ADULT

FED

INTERVENTIONAL

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

6031

2011-02

2013-04

2013-04

2015-02-10

2015-02-10

{ "Alcohol-HIV Risk Reduction Counseling": [ { "intervention_type": "BEHAVIORAL" } ], "Placebo Intervention": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT03142087

The Effect of Virtual Reality Exercises on Balance in Children With Brain Tumors

https://clinicaltrials.gov/study/NCT03142087

COMPLETED

30 patients with brain tumor will be included in the study between the ages of 6 and 18 who have undergone surgery. Patients included in the study will be randomly assigned to two groups. The study group will be included in the Nintendo Wii Fit Plus Balance Game exercise program under the supervision of a physiotherapist for 2 days per week for 8 weeks. The control group will be taken to the conventional exercise program under the supervision of a physiotherapist for 2 days a week, 1 hour a day. The assessments will be made before the exercise program begins and at the end of the 8th week. Patients physical measurements were assessed by anthropometric evaluations, muscle strength measurement, pain Visual Analogue Scale, walking Observational Walking Analysis, Balanced Pediatric Functional Range Test, Timed Up and Go (TUG) and one foot standing test and Nintendo Wii Fit Plus Balance Assessment, Functional capacity 2 min. With Walking Test, fatigue with PedsQL Multidimensional Fatigue Scale, daily life activities will be evaluated with WeeFIM.

NO

Postural Balance

OTHER: exercises

the effects of virtual reality exercises evaluating with Nintendo Wii Fit Plus on balance, Nintendo Wii Fit Plus Game Console evaluation parameters which are percentage of weight bearing and central of gravity, change from baseline balance at 8 weeks

Bezmialem Vakif University

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

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

mtanriverdi88

2017-03-21

2018-01-01

2018-01-01

2017-05-05

2018-01-05

Bezmialem Vakıf University, Istanbul, Turkey

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

NCT05476887

To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104

https://clinicaltrials.gov/study/NCT05476887

RECRUITING

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of KP104 in complement inhibitor-naïve participants with PNH. The study will be conducted in 2 parts. Part 1 is a dose-selection study to assess escalating doses and varying dose intervals of KP104. Part 2 is a proof-of-concept (POC) study assessing the efficacy of the optimal intravenous (IV) loading dose followed by the optimal maintenance dose and regimen of KP104. Participants who complete the Initial Treatment Period and demonstrate benefit from KP104 will be eligible for a 9-month open-label extension (OLE) treatment period.

NO

Paroxysmal Nocturnal Hemoglobinuria

DRUG: KP104

Part 1: Number of participants with Dose-limiting toxicities (DLT), A DLT is defined as any adverse event considered by the investigator to be KP104-related with a severity greater than or equal to (>=) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 3 which also represents a shift from baseline clinical status of > 1 NCI CTCAE grade. A hypersensitivity/administration reaction occurring with a severity of Grade 2 despite the use of pre-medications will also be designated as a DLT., Up to Week 4|Part 2: Percentage of participants with >= 2 grams per deciliter (g/dL) increase in hemoglobin level from Baseline in the absence of transfusion for weekly dosing, Blood samples will be collected for the analysis of increase in hemoglobin levels in the absence of transfusion., Baseline and at Week 12|Part 2: Percentage of participants with >= 2 g/dL increase in hemoglobin level from Baseline in the absence of transfusion for biweekly dosing, Blood samples will be collected for the analysis of increase in hemoglobin levels in the absence of transfusion., Baseline and at Week 13|Open-label Extension (OLE): Number of participants reporting Treatment Emergent Adverse Events (TEAEs), treatment-emergent serious adverse events (TESAEs) and AEs of special interest (AESIs), Up to 9 months

Part 2: Change from Baseline in serum lactate dehydrogenase (LDH) levels for weekly dosing, Blood samples will be collected for the analysis of serum LDH., Baseline and at Week 12|Part 2: Change from Baseline in serum LDH levels for biweekly dosing, Blood samples will be collected for the analysis of serum LDH., Baseline and at Week 13|Part 2: Change from Baseline in hemoglobin level for weekly dosing, Blood samples will be collected for the analysis of hemoglobin level, Baseline and at Week 12|Part 2: Change from Baseline in the hemoglobin level for biweekly dosing, Blood samples will be collected for the analysis of hemoglobin level., Baseline and at Week 13|Part 2: Change from Baseline in red blood cell (RBC) transfusion dependence for weekly dosing, The RBC transfusion dependence is the difference in the volume of RBC transfusions per month for the 3 months prior to initiation of investigational product versus the volume of RBC transfusions per month for each month on study., Baseline and at Week 12|Part 2: Change in RBC transfusion dependence for biweekly dosing, The RBC transfusion difference is the difference in the volume of RBC transfusions per month for the 3 months prior to initiation of investigational product versus the volume of RBC transfusions per month for each month on study., Baseline and at Week 13|Part 1 and 2: Number of participants reporting TEAEs, TESAEs and AESIs, Up to Week 13|Part 1 and 2: Concentration within one hour of end of infusion (CEOI) of KP104, Up to Week 13|Part 1 and 2: Trough concentration (Ctrough) of KP104, Up to Week 13

Kira Pharmacenticals (US), LLC.

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

KP104-201

2022-11-25

2024-11

2025-02

2022-07-27

2023-03-08

Peking Union Medical College Hospital, Beijing, China|Jiangsu Province Hospital, Nanjing, China|Chinese Academy of Medical Sciences Peking Union Medical College - Institute of Hematology Blood Diseases Hospital, Tianjin, China|Henan Cancer Hospital, Zhengzhou, China

{ "KP104": [ { "intervention_type": "DRUG" } ] }

NCT01401387

Pancreatic Enzyme Suppletion in Pancreatic Cancer

https://clinicaltrials.gov/study/NCT01401387

EPC

WITHDRAWN

This study will evaluate the effect of immediate pancreatic enzyme suppletion on the physical and mental health status and survival of patients who are diagnosed with pancreatic cancer and are highly likely to develop exocrine pancreatic insufficiency during their disease process.

NO

Adenocarcinoma of the Pancreas|Normal Pancreatic Exocrine Function

OTHER: Timing of start treatment with pancreatic enzymes|OTHER: Timing of start treatment with pancreatic enzymes

To evaluate if prescribing pancreatic enzymes in patients with pancreatic cancer leads to a decrease in weight loss., Percentage of change in body weight ((index weight - monthly weight)/ index weight) x100% during the 6 months of follow-up. This will be measured on a monthly basis and measured by area under the ROC (Receiver Operating Characteristic) curve, every month during 6 months after inclusion

improvement of the nutritional status, Nutritional deficiencies, 1 sample of blood will be drawn (3 times 8ml of blood): * Glucose, HbA1c (glycol Hb) * Magnesium, phosphate, ferritin * Hb * albumin * total protein * calcium * folic acid * vitamin A, E, B12 * 1,25-di-OH-Vitamine D * 25-hydroxy vitamin D (25-OH-vitamin D), every three months|quality-of-life, SF36 questionnaire, on a monthly base during 6 months after inclusion|improvement of the nutritional status, A monthly patient journal which will focus on the presence or absence of steatorrhea-related symptoms, every month during six months after inclusion

Foundation for Liver Research

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

EPC 11-01|2011-003373-28

2011-10

2013-05

2013-05

2011-07-25

2013-02-22

Erasmus Medical Center, Rotterdam, Zuid-Holland, 3000 WB, Netherlands

{ "Timing of start treatment with pancreatic enzymes": [ { "intervention_type": "OTHER" }, { "intervention_type": "OTHER" } ] }

NCT03327987

Early Flu Shots in SOT

https://clinicaltrials.gov/study/NCT03327987

WITHDRAWN

Although time from transplant has been a factor in vaccine response, there is limited data on immunizations that occur in the first post-transplant year, and there are no data that suggest influenza vaccination early post-transplant may have any adverse effects on the graft. It is suggested that early vaccinations may lead to reduced immunogenicity due to induction immunosuppression. However, not vaccinating patients may leave them vulnerable to influenza infection for a period of time. This study is designed to look at the immunogenicity and side effects of the standard of care influenza vaccine in patients between 31 and 365 days post-transplant.

NO

Influenza|Solid Organ Transplant

BIOLOGICAL: standard of care influenza vaccine

Vaccine immunogenicity, Vaccine immunogenicity based on assessment of pre- and post-vaccine (4 weeks) antibody titer. A positive vaccine response will be defined based on: * Seroconversion rate: serological response with a four-fold or greater increase in HAI antibody titers to each of the three antigens in the vaccine, and * Seroprotection rate: HAI titers of ≥1:40 to each of the three antigens post-immunization., 4 weeks

Safety- adverse events, Local and systemic adverse events to vaccination, 7 days|Safety- graft rejection, Rates of biopsy proven allograft rejection in the 6 months following vaccination, 6 months|Safety- HLA, Development of de novo or increased titer of HLA alloantibody and specifically DSA (donor specific antibody). The 4 weeks post-vaccine sample will be compared with the pre-vaccine samples., 4 weeks|Vaccine efficacy- CMI, Analysis of CMI in a subgroup of 60 patients (influenza strain-specific CD4+ and CD8+ T-cell responses; detectable vs. non-detectable and absolute percentage) at four weeks post-vaccine vs. pre-vaccine sample. CMI responses will also be correlated with HAI responses., 4 weeks|Vaccine efficacy- infection, Documented influenza infection (i.e., microbiology proven by the direct fluorescent antibody, viral culture, or PCR) in the six months following vaccination., 6 months

University Health Network, Toronto

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

17-5960

2019-05-07

2019-05-07

2019-05-07

2017-11-01

2020-10-20

University Health Network, Toronto General Hospital, Multi-Organ Transplant, Toronto, Ontario, M5G2N2, Canada

{ "Influenza vaccine": [ { "intervention_type": "BIOLOGICAL", "description": "standard of care influenza vaccine", "name": "Influenza vaccine", "synonyms": [ "Afluria", "Influenza vaccine", "Fluarix", "Fluzone", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Influenza%20vaccine", "generic_names": [ "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant" ] } ] }

NCT06353087

Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry)

https://clinicaltrials.gov/study/NCT06353087

ATTRACT

NOT_YET_RECRUITING

This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics.

NO

Dermatitis, Atopic|Dermatitis|Eczema|Skin Diseases|Immune System Diseases|Janus Kinase Inhibitors

Percentage of Participants Achieving >= 75% Improvement From Baseline in Eczema Area and Severity Index (EASI-75) Response at Week 2, 12, 52, EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD., Week 2, 12, 52|Percentage of Participants Achieving >= 90% Improvement From Baseline in Eczema Area and Severity Index (EASI-90) Response at Week 2, 12, 52, EASI quantifies severity of AD based on severity of lesion clinical signs and percentage (%) of body surface area (BSA) affected. Severity of clinical signs of AD lesions (erythema, induration/papulation, excoriation and lichenification) were scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin)] and lower limbs [including buttocks]) on a 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based on % BSA with AD in body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, with higher scores indicating greater severity of AD., Week 2, 12, 52|Percentage of Participants Achieving Investigators Global Assessment (IGA) Response of Clear (0) or Almost Clear (1) and Greater Than or Equal to 2 Points Improvement From Baseline at Week 2, 12, 52, IGA assesses severity of AD on a 5 point scale (0 to 4, higher scores indicate more severity). Scores: 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting; 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Assessment excluded sole, palms and scalp., Week 2, 12, 52

Duration of Abrocitinib Treatment: All Participants, Duration of treatment with abrocitinib was the time from date of start of abrocitinib treatment to date of end of abrocitinib treatment or of latest follow-up if not suspended., During post-index period (12 months duration post index date)|Demographic and baseline characteristics, During pre-index period|Percent Change From Baseline in Eczema Area and Severity Index (EASI) Total Score at Week 2, 4, 12, 16, 24, and 52, EASI evaluates severity of participants AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (>0 to <10%), 2 (10 to <30%), 3 (30 to <50%), 4 (50 to <70%), 5 (70 to <90%) and 6 (90 to 100%). Total EASI score =0.1*Ah*(Eh+Ih+Exh+Lh) + 0.2*Au*(Eu+Iu+ExU+Lu) + 0.3*At*(Et+It+Ext+Lt) + 0.4*Al*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD., Baseline, Week 2, 4, 12, 16, 24, and 52|Change From Baseline in Investigators Global Assessment (IGA) at Weeks 2, 4, 12, 16, 24, and 52, IGA assesses severity of participants AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp., Baseline, Week 2, 4, 12, 16, 24, and 52|Change From Baseline in Percentage Body Surface Area at Week 2, 4, 12, 16, 24, and 52, 4 body regions were evaluated: head and neck, upper limbs, trunk (including axillae and groin) and lower limbs (including buttocks). Scalp, palms and soles were excluded. BSA was calculated using handprint method. Number of handprints (size of participants hand with fingers in a closed position) fitting in the affected area of a body region was estimated. Maximum number of handprints were 10 for head and neck, 20 for upper limbs, 30 for trunk and 40 for lower limbs. Surface area of body region equivalent to 1 handprint: 1 handprint was equal to 10% for head and neck, 5% for upper limbs, 3.33% for trunk and 2.5% for lower limbs. Percent BSA for a body region was calculated as = total number of handprints in a body region * % surface area equivalent to 1 handprint. Overall % BSA for an individual: arithmetic mean of % BSA of all 4 body regions, ranges from 0 to 100%, with higher values representing greater severity of AD., Baseline, Week 2, 4, 12, 16, 24, and 52|Change From Baseline in Patient-Oriented Eczema Measure (POEM) at Week 2, 4, 12, and 52, POEM is a 7-item participant reported outcome (PRO) measure used to assess the impact of AD (dryness, itching, flaking, cracking, sleep loss, bleeding and weeping) over the past week. Each item is scored as no days (0) , 1-2 days (1) , 3-4 days (2) , 5-6 days (3) and every day (4) . The score ranges from 0 to 28, where higher score indicated greater severity., Baseline, Week 2, 4, 12, and 52|Change from baseline of Atopic Dermatitis Control Tool (ADCT) score at Week 2, 4, 12, and 52, The Atopic Dermatitis Control Tool (ADCT) is a brief patient self-administered instrument designed and validated to assess patient-perceived AD control; AD symptoms and impacts are evaluated over the past week, including overall severity of symptoms, days with intense episodes of itching, intensity of bother, problem with sleep, impact on daily activities, and impact on mood or emotions, Baseline, Week 2, 4, 12, and 52|Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score to Week 2, 4, 12, and 52, The DLQI was a 10-item questionnaire that measures the impact of skin disease on participants quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. The DLQI total score ranges from 0 (not at all) to 30 (very much): 0-1 = no effect at all on the participants life; 2-6 = small effect on the participants life; 7-12 = moderate effect on the participants life; 13-18 = very large effect on the participants life; 19-30 = extremely large effect on the participants life. Higher scores indicate more impact on quality of life of participants., Baseline, Week 2, 4, 12, and 52|Change From Baseline in Patient Global Assessment (PtGA), The PtGA asked the participant to evaluate the overall cutaneous disease at that point in time on a single-item, 5-point scale. The same category labels used in the IGA were used for the PtGA, ie, severe (4) , moderate (3) , mild (2) , almost clear (1) , and clear (0) . The PtGA was completed as per schedule of activities., Baseline, Week 2, 4, 12, 16, 24, and 52|Percentage Change From Baseline in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Weeks 2, 4, 12, 16, 24, and 52, The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: How would you rate your itch due to AD at the worst moment during the previous 24 hours? The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch., Baseline, Week 2, 4, 12, 16, 24, and 52|Percentage of Participants Achieving >=4 Points Reduction in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52, The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: How would you rate your itch due to AD at the worst moment during the previous 24 hours? The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch., Baseline, Week 2, 4, 12, 16, 24, and 52|Percentage of Participants Achieving 0 or 1 in Peak Pruritus Numerical Rating Scale (PP-NRS) From Baseline at Week 2, 4, 12, 16, 24, and 52, The severity of itch (pruritus) due to AD was assessed using a horizontal NRS. Participants at specified time points were asked the following question: How would you rate your itch due to AD at the worst moment during the previous 24 hours? The scale ranged from 0-10, where 0= no itch and 10= worst itch imaginable. Higher scores indicated worse itch., Baseline, Week 2, 4, 12, 16, 24, and 52

Pfizer

ALL

CHILD, ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

B7451114

2024-04-01

2025-11-15

2025-11-15

2024-04-08

2024-04-08

{}

NCT00698087

Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B

https://clinicaltrials.gov/study/NCT00698087

COMPLETED

The purpose of the study is to compare the safety, reactogenicity and immunogenicity of different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B when administered at 0, 2 months with a booster at month 12 if necessary

NO

Hepatitis B

BIOLOGICAL: MPL-Adjuvanted recombinant hepatitis B vaccine|BIOLOGICAL: Engerix™-B

Anti-HBs antibody concentrations, At M3 and M13|Occurrence of local and general solicited symptoms, 4-day follow-up after vaccination|Occurrence of unsolicited symptoms, 30-day follow-up after vaccination

SAEs, Throughout the study up to 30 days after last vaccination|Anti-HBs antibody concentrations, Months 2, 3, 6, 9, 12, 13

GlaxoSmithKline

ALL

ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

208129/016

1995-01

1996-02

1996-02

2008-06-16

2008-06-16

GSK Clinical Trials Call Center, Vienna, Austria

{ "MPL-Adjuvanted recombinant hepatitis B vaccine": [ { "intervention_type": "BIOLOGICAL" } ], "Engerix\u2122-B": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT04573387

Exhaustive Drainage Versus Fixed-time Drainage for Chronic Subdural Hematoma After One-burr Hole Craniostomy

https://clinicaltrials.gov/study/NCT04573387

ECHO

RECRUITING

A prospective, multicenter, randomized controlled trial is designed to compare the recurrence rates and clinical outcomes in patients with chronic subdural hematoma using exhaustive drainage or fixed-time drainage after one-burr hole craniostomy.

NO

Hematoma, Subdural, Chronic

PROCEDURE: Operation|PROCEDURE: Fixed-time drainage|PROCEDURE: Exhaustive drainage|PROCEDURE: Postoperative computed tomography

Rate of re-operations of chronic subdural hematoma, Rate of re-operations between fixed-time drainage group and exhaustive drainage group, From operation up to 6 months postoperatively

Change of Modified Rankin Scale (MRS) between groups from baseline to 6 months after operation, Modified Rankin Scale ranges from score 1 to 6, and higher scores mean a worse clinical outcome, where score 1 indicates normal daily functionality and score 6 indicates death., At baseline, and at 1, 3, and 6 months after operation|Change of Markwalder Grading Scale (MGS) between groups from baseline to 6 months after operation, Markwalder Grading Scale ranges from grade 0 to 4, and higher scores mean a worse neurological outcome, where grade 0 indicates normal neurological function and grade 4 indicates coma., At baseline, and at 1, 3, and 6 months after operation|Change of health related quality of life between groups from baseline to 6 months after operation, A standardized instrument, EuroQoL 5-Dimension 5-Level (EQ-5D-5L) questionnaire, will be used as a generic measure of health related quality of life. The questionnaire contains 5 dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension rates across five levels, including No problems-Slight problems-Moderate problems-Severe problems-Unable to., At baseline, and at 1, 3, and 6 months after operation|Rate of mortality between groups within 6 months, Rate of mortality between fixed-time drainage group and exhaustive drainage group, From operation up to 6 months postoperatively|Rate of complications and adverse events between groups within 6 months, Rate of complications and adverse events between fixed-time drainage group and exhaustive drainage group within 6 months, From operation up to 6 months postoperatively

Beijing Tiantan Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

KY 2020-094-02

2020-12-29

2024-07-09

2024-07-30

2020-10-05

2024-01-23

Beijing Ditan Hospital, Capital Medical University, Beijing, Beijing, 100015, China|Beijing Chaoyang Hospital, Capital Medical University, Beijing, Beijing, 100020, China|Beijing Xuanwu Hospital, Capital Medical University, Beijing, Beijing, 100053, China|Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, 100070, China|Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing, 100730, China|Beijing Luhe Hospital, Capital Medical University, Beijing, Beijing, 101100, China|Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing, China|Puning Peoples Hospital, Puning, Guangdong, 515300, China|Xinxing County Peoples Hospital, Yunfu, Guangdong, 527400, China|The Second Nanning Peoples Hospital, Nanning, Guangxi, 530031, China|Wei County Hospital of Traditional Chinese Medicine, Handan, Hebei, 056800, China|Hengshui Peoples Hospital, Hengshui, Hebei, 053000, China|First Hospital of Qinhuangdao, Qinhuangdao, Hebei, 066000, China|North China University of Science and Technology Affiliated Hospital, Tangshan, Hebei, 063000, China|Xiahuayuan District Hospital, Zhangjiakou, Hebei, 075000, China|First Peoples Hospital of Lianyungang, Lianyungang, Jiangsu, 222061, China|Yancheng Third Peoples Hospital, Yancheng, Jiangsu, 224001, China|Peoples Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, 750002, China|Tianjin Huanhu Hospital, Tianjin, Tianjin, 300350, China

{ "Operation": [ { "intervention_type": "PROCEDURE" } ], "Fixed-time drainage": [ { "intervention_type": "PROCEDURE" } ], "Exhaustive drainage": [ { "intervention_type": "PROCEDURE" } ], "Postoperative computed tomography": [ { "intervention_type": "PROCEDURE" } ] }

NCT01071187

Varenicline for Alcohol Dependence

https://clinicaltrials.gov/study/NCT01071187

UNKNOWN

The varenicline for alcohol dependence trial investigates the efficacy of varenicline versus placebo for maintaining abstinence in the postacute treatment of alcohol dependent subjects. The main study hypothesis is that subjects treated with varenicline have more abstinent days during the study.

NO

Alcohol Dependence

DRUG: Varenicline|DRUG: Placebo

Number of total alcohol abstinent days during he 12 weeks study period, percentage of the treatment days, 12 weeks

Time in days to first alcoholic drink, assessed by the time-line-follow-back-interview, 12 weeks|Proportion of abstinent patients during the study, percentage of all patients, 12 weeks|Number of standard drinks per drinking day, assessed by the time-line-follow-back-interview., 12 weeks|Time in days to first heavy drinking, assessed by the time-line-follow-back-interview., 12 weeks|Number of days with heavy drinking as percentage of all treatment days, assessed by time-line-follow-back-interview., 12 weeks|Changes in gamma-glutamyl transpeptidase levels, 12 weeks|Occurrence of adverse events, 12 weeks|Compliance of the subjects, 12 weeks|alcohol craving assessed by the obsessive compulsive drinking scale (OCDS) and a visual analog scale (VAS), 12 weeks|Severity of the alcohol dependence assessed by the European Addiction Severity Index (EuropASI), 12 weeks|Absolute change in the Clinical Global Impression of Change (CGI), 12 weeks|Quality of life, assessed by the questionnaire for health condition Fragebogen zum allgemeinen Gesundheitszustand (SF-12), 12 weeks|Number of cigarettes per day, 12 weeks|Number of nicotine abstinent days, percentage of the treatment days, 12 weeks|Severity of the nicotine dependence, assessed by the Fagerstrom test for nicotine dependence, 12 weeks|Intensity of depressive symptoms, assessed by the Beck Depression Inventors (BDI), 12 weeks

Johannes Gutenberg University Mainz

Pfizer

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

2009-08-17|2009-015537-67

2010-03

2011-09

2011-09

2010-02-19

2010-09-15

Department of psychiatry, psychosomatics and psychotherapie, Markus hospital, Frankfurt am Main, Frankfurt am Main, Hessen, 60431, Germany|Department of psychiatry and psychotherapy, University medical center of the Johannes Gutenberg.university Mainz, Mainz, Rheinland-Pfalz, 55131, Germany

{ "Varenicline": [ { "intervention_type": "DRUG", "description": "Varenicline", "name": "Varenicline", "synonyms": [ "6,7,8,9-Tetrahydro-6,10-methano-6H-pyrazino(2,3-h)benzazepine", "see Champix", "varenicline", "Varenicline Tartrate", "Champix", "Vareniclina", "Vareniclinum", "Chantix", "Varenicline", "Tyrvaya" ], "medline_plus_id": "a621057", "generic_names": [ "Varenicline" ], "nhs_url": "https://www.nhs.uk/medicines/champix-varenicline", "mesh_id": "D000077444", "drugbank_id": "DB01273", "wikipedia_url": "https://en.wikipedia.org/wiki/Varenicline" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT01605487

Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria

https://clinicaltrials.gov/study/NCT01605487

PAFCUTIII

COMPLETED

Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany) will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C simultaneously in a standardized and reproducible way and thus the determination of individual temperature and/or stimulation time thresholds. In addition mediators related from activated must cells such as histamine, PAF, PGD2 should be identified in the period between the application of stimulus and the appearance of symptoms of cold urticaria and should be characterized qualitatively and quantitatively.

NO

Cold Contact Urticaria

DRUG: Rupatadine|DRUG: Rupatadine|DRUG: Rupatadine|DRUG: Rupatadine|DRUG: Rupatadine|DRUG: Rupatadine

Critical stimulation time threshold(CSTT) after challenge with cold, Critical stimulation time threshold (CSTT) determines the shortest stimulation time sufficient for inducing a wheal-and-flare reaction, Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)|Critical temperature threshold (CTT)after challenge with cold, Critical temperature threshold (CTT) determines the highest temperature sufficient for inducing a wheal-and-flare reaction, Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)

Mast cell mediator release, Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)|Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria, Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital sings and adverse event reporting, up to 9 weeks

Charite University, Berlin, Germany

Hospital del Mar

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

PAFCUTIII

2012-06

2013-09

2014-10

2012-05-25

2014-10-15

Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany

{ "Rupatadine": [ { "intervention_type": "DRUG", "description": "Rupatadine", "name": "Rupatadine", "synonyms": [ "Rupatadina", "Rupatadine" ], "drugbank_id": "DB11614", "generic_names": [ "Rupatadine" ] }, { "intervention_type": "DRUG", "description": "Rupatadine", "name": "Rupatadine", "synonyms": [ "Rupatadina", "Rupatadine" ], "drugbank_id": "DB11614", "generic_names": [ "Rupatadine" ] }, { "intervention_type": "DRUG", "description": "Rupatadine", "name": "Rupatadine", "synonyms": [ "Rupatadina", "Rupatadine" ], "drugbank_id": "DB11614", "generic_names": [ "Rupatadine" ] }, { "intervention_type": "DRUG", "description": "Rupatadine", "name": "Rupatadine", "synonyms": [ "Rupatadina", "Rupatadine" ], "drugbank_id": "DB11614", "generic_names": [ "Rupatadine" ] }, { "intervention_type": "DRUG", "description": "Rupatadine", "name": "Rupatadine", "synonyms": [ "Rupatadina", "Rupatadine" ], "drugbank_id": "DB11614", "generic_names": [ "Rupatadine" ] }, { "intervention_type": "DRUG", "description": "Rupatadine", "name": "Rupatadine", "synonyms": [ "Rupatadina", "Rupatadine" ], "drugbank_id": "DB11614", "generic_names": [ "Rupatadine" ] } ] }

NCT02282787

Dexmedetomidine Adjuvant in Retinal Surgery

https://clinicaltrials.gov/study/NCT02282787

UNKNOWN

During LA in retinal surgery there is some problem as regard the lack of anaesthesia duration and unexpected globe movement .so many adjuvant was added to LA to overcome this disadvantages of LA such as clonidine and fentanyl . The investigators hypothesis is adding dexmedetomidine to pribulbal blocking LA will prolong anaesthesia duration and improve globe akinesia and decrease intraoperative supplementation of LA.There are Many studies had described the effects of dexmedetomidine on peripheral nerve blocks, spinal but up to date no knowledge is available on the impact of dexmedetomidine adjuvant to local anaesthetic in ophthalmic surgery

NO

Peribulbar Anesthesia

DRUG: DEXMEDETOMIDINE

onset, duration of the motor and sensory block, A block was considered satisfactory when complete akinesia occurred. In the absence of complete akinesia in any direction after 10 min, supplementary anesthesia given by a further injection of 2-4 ml of the test solution in the same manner as given before. Calculate the number of patients needed supplemental block were. The surgeon assessed the duration of surgery anesthesia and akinesia. Intraocular pressure measured before block, immediately after block and before surgical procedures, 10 minutes from injection

observe the adverse effects of Dexmedetomidine, ECG, invasive BP and pulse oximetry will apply to all patients. • The haemodynamic parameters (MAP and HR) will be continuously measured, and will be recorded at before induction (baseline), one minute after block . after 5 minutes then at the surgical incision, 15-min intervals intraoperatively, the end of surgery and10 and 20 minutes postoperatively. Incidence of Oculocardiac reflex (OCR) or any arrhythmia during surgery., during and after surgery

King Saud University

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

E-14-1291

2014-01

2015-01

2015-05

2014-11-04

2015-03-31

King Abdulaziz University Hospital at King Saud University, Riyadh, 11411, Saudi Arabia

{ "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" } ] }

NCT01422187

A Multicenter Extension Study of Taliglucerase Alfa in Adult Subjects With Gaucher Disease

https://clinicaltrials.gov/study/NCT01422187

COMPLETED

This is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with Gaucher disease who have enrolled in Protocol PB-06-003. Subjects will continue to receive an intravenous (IV) infusion of taliglucerase alfa every two weeks. The duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the Sponsor.

YES

Gaucher Disease

DRUG: Taliglucerase alfa

Spleen Volume, Spleen volume measured by MRI, 60 months

Liver Volume, Liver volume by MRI, 60 months|Platelet Count, Platelet count measure annually, 60 months|Hemoglobin, Hemoglobin measure yearly, 60 months

Pfizer

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

PB-06-007

2011-08

2014-05

2014-09

2011-08-23

2015-12-14

2023-04-19

{ "Taliglucerase alfa": [ { "intervention_type": "DRUG", "description": "Taliglucerase alfa", "name": "Taliglucerase alfa", "synonyms": [ "Taliglucerase alfa", "prGCD", "Glucosylcerebrosidase", "prGC-D" ], "drugbank_id": "DB08876", "generic_names": [ "Taliglucerase alfa" ] } ] }

NCT01168687

Effects of Levetiracetam (Keppra) on Alcohol Consumption

https://clinicaltrials.gov/study/NCT01168687

COMPLETED

The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a marker of intoxication) and the effects of levetiracetam on postural control.

YES

Alcohol Abuse|Drug Abuse

DRUG: Levetiracetam (Keppra)|DRUG: Placebo

Standard Alcoholic Drinks Per Treatment Period, The primary outcome of this study is to determine the effect of levetiracetam on alcohol consumption as measured by change in # of drinks during each treatment period., During each 14 day treatment period

University of California, San Francisco

United States Department of Defense|University of California

ALL

ADULT

OTHER

INTERVENTIONAL

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

H1815-29512-02|W81XWH-05-1-0215

2008-11

2009-11

2010-11

2010-07-23

2013-02-25

2020-08-28

Childrens Hospital Oakland Research Institute- CRC, Berkeley, California, 94705, United States

{ "Levetiracetam": [ { "intervention_type": "DRUG", "description": "Levetiracetam (Keppra)", "name": "Levetiracetam", "synonyms": [ "UCB 6474", "Ucb L059", "Desitrend", "Elepsia", "Ucb L060", "R-isomer Etiracetam", "Etiracetam, S isomer", "Levetiracetame", "Etiracetam, R-isomer", "UCB6474", "UCB-6474", "Etiracetam, (R)-", "Ucb-L059", "alpha-ethyl-2-oxo-1-Pyrrolidineacetamide", "Ucb-L060", "S-isomer Etiracetam", "Levetiracetam", "Keppra", "Etiracetam", "UcbL060", "Etiracetam, S-isomer", "Levetiracetamum", "alpha ethyl 2 oxo 1 Pyrrolidineacetamide", "Etiracetam, R isomer", "", "Etiracetamum", "Etiracetam", "\u00e9tirac\u00e9tam", "", "Etiracetamum", "Etiracetam", "\u00e9tirac\u00e9tam" ], "medline_plus_id": "a622013", "generic_names": [ "Levetiracetam", "Etiracetam", "Etiracetam" ], "nhs_url": "https://www.nhs.uk/medicines/levetiracetam", "mesh_id": "D018697", "drugbank_id": "DB01202" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT00226187

A Randomized Clinical Trial on Supplementation of DHA and AA to Preterm Infants

https://clinicaltrials.gov/study/NCT00226187

COMPLETED

A randomized, double-blind trial of docosahexaenoic and arachidonic acid supplementation in breast-fed preterm infants Background: Docosahexaenoic acid (DHA) and arachidonic acid (AA) are essential for preterm infants. Human milk and preterm formulas contain DHA and AA, but at lower concentrations than required to approximate utero accretion rate. Objective: To evaluate the effect of a high dose DHA and AA supplement to breast-fed preterm infants in the early neonatal period. Primary endpoints are neurodevelopment at 6 and 20 months of age. Design: A randomized double-blind placebo-controlled study is carried out in four Norwegian neonatal centers. Subjects and methods: Infants with birth weight < 1.5 kg are randomized to either an intervention or a control group. All infants receive fortified human milk, and a daily dose of 0.5 ml study oil per 100 ml milk. Infants in the intervention group receive oil with DHA and AA (Formulaid, Martek, USA), while the control oil contains vegetable oil without DHA or AA. Blood samples are collected at birth (cord), and at start and stop of the intervention. Plasma is analyzed for fatty acid pattern using high performance liquid chromatography.

NO

Infant, Low Birth Weight

PROCEDURE: Supplement of fatty acid (DHA and AA)

Cognitive development

Growth|Adverse events

University of Oslo

ALL

CHILD

OTHER

INTERVENTIONAL

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

1

2003-12

2005-09-26

2007-02-15

University of Oslo, Oslo, 0316, Norway

{ "Supplement of fatty acid (DHA and AA)": [ { "intervention_type": "PROCEDURE" } ] }

NCT02338687

Low Dose Calcium to Prevent Preeclampsia

https://clinicaltrials.gov/study/NCT02338687

AMCAL

COMPLETED

The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.

NO

Pre-Eclampsia|Hypertension, Pregnancy-Induced|Dietary Calcium Deficiency

DIETARY_SUPPLEMENT: calcium|BEHAVIORAL: Educational sessions

Preeclampsia, New onset of hypertension plus proteinuria after 20 weeks of pregnancy, at 20-40 weeks of pregnancy|Hypertensive disorders of pregnancy, New onset of hypertension, with or without proteinuria, after 20 weeks of pregnancy, at 20-40 weeks of pregnancy

Mean change in dietary calcium intake, At baseline, participants will provide a dietary record and again in the 3rd trimester. Changes in the mean dietary calcium intake will be calculated., at 30-36 weeks of pregnancy|Hospital admission due to hypertension, Admission (before labor) due to hypertension, at 20-40 weeks of pregnancy|Severe maternal morbidity, Eclampsia or HELLP (Hemolysis, Elevated Liver Enzymes, Low Platelet) syndrome, at 20-40 weeks of pregnancy|Maternal mortality, any cause maternal mortality, starting at 20 weeks up to hospital discharge|Gastrointestinal side effects of calcium, incidence of flatulence, obstipation or other symptoms any time up to delivery, at 20-40 weeks of pregnancy|Maternal admission to Intensive Care Unit, admission for any cause, at 20-40 weeks of pregnancy|Admission to Neonatal Intensive Care Unit, admission for any cause, from delivery to infant discharge|Preterm birth, Delivery before 37 weeks, at 20-36 weeks|Low birth weight, Birth weight less than 2500 g, at 20-40 weeks|Small for gestational age infant, Birth of an infant whose weight is below the 10th percentile for gestational age, at 20-40 weeks

Federal University of São Paulo

PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde)|FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)|Universidade Federal do Amazonas

FEMALE

CHILD, ADULT

PHASE4

OTHER

INTERVENTIONAL

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

528759

2014-10

2018-10

2018-10

2015-01-14

2023-10-12

Universidade Federal do Amazonas, Manaus, Amazonas, 69077000, Brazil

{ "calcium": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Educational sessions": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04603287

A Study of SI-B001, an EGFR/HER3 Bispecific Antibody, in Locally Advanced or Metastatic Epithelial Tumors

https://clinicaltrials.gov/study/NCT04603287

RECRUITING

In phase Ia study, the safety and tolerability of SI-B001 in patients with locally advanced or metastatic epithelial malignancies will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of SI-B001. In the phase Ib study, the safety and tolerability of SI-B001 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined. In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of SI-B001 in patients with locally advanced or metastatic epithelial tumors will be evaluated.

NO

Locally Advanced or Metastatic Epithelial Tumor

DRUG: SI-B001

Phase Ia: Dose limiting toxicity (DLT), DLTs are assessed according to NCI-CTCAE v5.0 during the first cycle (28 days) and defined as occurrence of any of the toxicities in DLT definition if judged by the investigator to be possibly, probably or definitely related to study drug administration., Up to 28 days after the first dose of SI-B001|Phase Ia: Maximum tolerated dose (MTD), MTD is defined as the highest dose level at which no more than 1 in 6 participants experienced a DLT during the first cycle (within 28 days of the first administration)., Up to 28 days after the first dose of SI-B001|Phase Ib: Recommended Phase II Dose (RP2D), The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of SI-B001., Up to 28 days after the first dose of SI-B001