Datasets:

pankajrajdeo

/

LungClinicalTrials

like 0

NCT06442254

The Effects of Virtual Reality in Intensive Care Patients

https://clinicaltrials.gov/study/NCT06442254

NOT_YET_RECRUITING

Weakness of respiratory muscles delays weaning from the ventilator, prolongs hospital stay and increases treatment costs. Conventional treatments for respiratory muscles reverse these negative effects. İntensive care services are a set of services that have a very important place in public health care due to the vital support and they provide to all critically ill patients. This care services are constantly improving with the use of technological innovations. With the development of technology, virtual reality application has begun to be used therapeutically in the field of physiotherapy. Virtual reality is the combination of reality and imagination with fictions created using technology. Today, developers can surprisingly create realistic worlds filled with artificial intelligence that behaves believably. Studies have shown positive effects of virtual reality on acute respiratory frequency, pain and fatigue, and in light of this, it was predicted that it would be beneficial to apply to intensive care patients. This study will shed light on the rehabilitation of patients in intensive care and contribute to the literature.

NO

Virtual Reality|Intensive Care Unit Acquired Weakness

OTHER: Virtual Reality

Respiratory Muscle Strength, Maximal inspiratory pressure (MIP) is a measure of the strength of inspiratory muscles, primarily the diaphragm, and allows for the assessment of ventilatory failure, restrictive lung disease and respiratory muscle strength. MIP is measured at residual volume of lung., 3 days|Respiratory Muscle Strength, For respiratory muscle strength, maximal expiratory pressure (MEP) will evaluate using an electronic pressure transducer. MEP is measured from total lung capacity.particularly the diaphragm, while MEPs measure the strength of abdominal and intercostal muscles. For respiratory muscle strength, maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) were evaluated using an electronic pressure transducer. MIP was measured at residual volume, and MEP was measured from total lung capacity., 3 days|Richmond Agitation-Sedation Scale, Interrater reliability. In many intensive care units, the Richmond Agitation-Sedation Scale (RASS) is used to assess the level of sedation. This scale is designed with a three-step procedure that can help give a RASS score range of -5 to +4.The RASS score ranges from -5 (unarousable) to +4 (combative), with 0 meaning alert and calm., 3 days|SOFA (Sequential Organ Failure Assessment), It evaluates morbidity through six systems (liver, central nervous system, respiratory system, cardiovascular system, renal and coagulation). For each system, points between 1 and 4 are given and the total score is evaluated between 6 and 24. In this score, as the score increases for each system, organ failure is considered to occur., 3 days|Visuel Anaolog Scale, A Visual Analogue Scale (VAS) is one of the pain rating scales used for the first time in 1921 by Hayes and Patterson[1]. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.For pain intensity according to VAS, no pain is usually rated as 0 points and worst pain imaginable as 10 points. Ranges for pain intensity; <3. mild pain, 3-6 moderate pain, >6 severe pain, 3 days|The Glasgow Coma Scale, It is a tool that healthcare providers use to measure decreases in consciousness. The scores from each section of the scale are useful for describing disruptions in nervous system function and also help providers track changes. It s the most widely used tool for measuring comas and decreases in consciousness.The components of the Glasgow Coma Scale include 4 different scores for the eye-opening response, 5 for the verbal response, and 6 for the motor response. The total score has values between 3 and 15. Three is the worst and 15 is the highest., 3 days|APACHE II Score, It is a general measure of disease severity based on current physiologic measurements, age & previous health conditions. The score can help in the assessment of patients to determine the level & degree of diagnostic & therapeutic intervention.APACHE II total score consists of three subheadings: acute physiology score, age and chronic health assessment; the highest value is 71. Mortality is 25% when the total score is 25, and increases to 80% when the total score is 35 and above., 3 days|Chelsea Critical Care Physical Assessment Tool (CPAx), İt is a test used on male and female patients in the intensive care unit (ICU) to assess physical and respiratory function impairments and morbidity., 3 days|Body temperature, The average normal body temperature is generally accepted as 37°C. Some studies have shown that the normal body temperature can have a wide range, from 36.1°C to 37.2°C, 3 days|Blood pressure, Normal blood pressure for most adults is defined as a systolic pressure of less than 120 and a diastolic pressure of less than 80. Elevated blood pressure is defined as a systolic pressure between 120 and 129 with a diastolic pressure of less than 80., 3 days|Respiratory rate, The normal range of breathing rate per minute in an average adult, for a person at rest, is 12 - 20 breaths per minute. Any person having a breathing rate under 12 or over 25 is considered to be breathing abnormally., 3 days|Pulse rate, The normal pulse for healthy adults ranges from 60 to 100 beats per minute. The pulse rate may fluctuate and increase with exercise, illness, injury, and emotions., 3 days|The Physical Function in ICU Test, The PFIT-s is a battery outcome measure involving four components: sit to stand assistance, marching on the spot cadence, shoulder flexor and knee extensor strength., 3 days

Hand Strength, Hand muscle strength will be measured with a jamar device., 3 days|Modified Borg Dyspnea Scale, It is a categorical scale with a score from 0 to 10, where 0 represents normal breathing and 10 represents maximum dyspnea., 3 days|Pa02, It is the partial pressure of oxygen in arterial blood. It is used to evaluate oxygenation. Normal values are 80-100 mmHg., 3 days|PaCO2, It is the partial pressure of carbon dioxide in arterial blood. It is an indicator of alveolar ventilation. Normal values are 35-45 mmHg., 3 days|HCO3, It is the serum concentration of bicarbonate ion. It is an important buffer in the blood and is used to evaluate the metabolic component of acid-base balance. Standard bicarbonate: It is the bicarbonate value that should be present in the blood under standard conditions (37°C temperature and 40 mmHg PCO2). Normally it is 22-26 mEq/L., 3 days|Ph, It is used to determine the H+ status of the blood. It shows that the patient is in acidosis or alkalosis, but it is not possible to understand the type by pH. Normal values are 7.35-7.45., 3 days|Confusion Assessment Method for the ICU, The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit. The CAM-ICU assesses for the four features of delirium: Feature 1 is an acute change in mental status or a fluctuating mental status, Feature 2, is inattention, Feature 3, is altered level of consciousness and Feature 4, is disorganized thinking., 3 days

Istinye University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

23-152

2024-06-05

2024-07-10

2024-07-26

2024-06-04

2024-06-04

{ "Virtual Reality": [ { "intervention_type": "OTHER" } ] }

NCT05568654

Reducing Antimicrobial Overuse Through Targeted Therapy for Patients With Community-Acquired Pneumonia

https://clinicaltrials.gov/study/NCT05568654

RECRUITING

The purpose of this study is to reduce the exposure of broad-spectrum antimicrobials by optimizing the rapid detection of CAP pathogens and improving rates of de-escalation following negative cultures. To accomplish this, we will perform a 3-year, pragmatic, multicenter 2 X 2 factorial cluster randomized controlled trial with four arms: a) rapid diagnostic testing b) pharmacist-led de-escalation c) rapid diagnostic testing + pharmacist-led de-escalation and d) usual care

NO

Community-Acquired Pneumonia|Antimicrobial Stewardship|Point-of-Care Testing

DIAGNOSTIC_TEST: Rapid Diagnostic Testing|OTHER: Pharmacist-led de-escalation

Number of days of broad-spectrum antibiotic therapy, duration of exposure to broad-spectrum antimicrobial therapy defined by the number of days of antibiotic therapy in the first 21 days of admission as per National Healthcare Safety Network (NHSN) guidelines, first 21 days of admission

viral testing ordered (yes/no), Proportion of patients in whom viral testing was ordered. We will look at each virus individually as well as all viruses together (i.e. any viral testing), Up to 48 hours|detection of influenza virus (yes/no), Proportion of patients who test positive for influenza, Up to 48 hours|detection of RSV (yes/no), Proportion of patients who test positive for RSV, up to 48 hours|detection of viruses/atypical bacteria in the respiratory panel (yes/no), Proportion of patients who test positive for each of the viruses/atypical bacteria in the respiratory panel, up to 48 hours|treatment with anti-viral medications, treatment with anti-viral medications (oseltamivir, zanamivir, peramivir, baloxavir, ribavirin, remdesivir, nirmatrelvir, COVID-19 medications), up to 48 hours|treatment with antiviral medications, treatment with antiviral medications (oseltamivir, zanamivir, peramivir, baloxavir, ribavirin, remdesivir, nirmatrelvir, COVID-19 medications), within 21 days|S. pneumoniae urinary antigen test (UAT) performed, Proportion of patients in whom UAT is performed, up to 48 hours|positive pneumococcal UAT, Proportion of patients with positive pneumococcal UAT, up to 48 hours|de-escalation by 72 hours from admission (yes/no), Proportion of patients whose broad spectrum antimicrobials (imipenem, meropenem, piperacillin-tazobactam, aztreonam, cefepime, ceftazidime, tobramycin, ceftazidime-avibactam, ceftolozane-tazobactam, meropenem-vaborbactam, imipenem-cilastatin-relebactam, cefiderocol, ceftaroline, tigecycline, eravacycline, amikacin, linezolid or vancomycin) are de-escalated, within 72 hours from admission.|re-escalation to broad-spectrum antibiotics after de-escalation (yes/no), Proportion of patients whose antibiotics were de-escalated and that were subsequently re-escalated to broad-spectrum antibiotics (imipenem, meropenem, piperacillin-tazobactam, aztreonam, cefepime, ceftazidime, tobramycin, ceftazidime-avibactam, ceftolozane-tazobactam, meropenem-vaborbactam, imipenem-cilastatin-relebactam, cefiderocol, ceftaroline, tigecycline, eravacycline, amikacin, linezolid or vancomycin)., by 21 days from admission|total duration of any antibacterial antibiotic, Total duration of any antibacterial antibiotic treatment up to 21 days, including re-initiation of antibiotics, up to 21 days|14-day mortality, proportion of patients who die by 14 days, up to 14 days|30-day mortality, proportion of patients who die by 30 days, up to 30 days|ICU transfer after admission (> 24 hours after admission), proportion of patients transferred to the ICU >24 hours after admission up to 21 days, up to 21 days|healthcare-associated C.difficile Infection (CDI) (yes/no), CDI after 72 hours of admission. Proportion of patients with CDI after 72 hours of admission (healthcare-associated CDI) until discharge, after 72 hours of admission until discharge|acute kidney injury after 48 hours (yes/no) after 48 hours, Proportion of patients with AKI after 48 hours of admission, up to 21 days, up to 21 days|total inpatient cost (from hospital s cost accounting system), total inpatient cost (from hospital s cost accounting system) - from admission to discharge or 21 days, whichever comes first, from admission to discharge or 21 days, whichever comes first|hospital length-of-stay (days, hours), length of stay will be calculated in days from the time of admission to the time of discharge, days from the time of admission to the time of discharge|empyema (yes/no), empyema (pus in the pleural space), from 48 hours to 21 days|30-day readmission (yes/no), 30-day hospital readmission, up to 30 days after discharge|Infection with a resistant organism in the future (yes/no), up to 6 months after discharge. Resistance to CAP therapy will be defined as resistance to either a respiratory quinolone or to both a beta-lactam/3rd generation cephalosporin and a macrolide. Multi-drug resistance will be defined as any CAP bacterial isolate that tests either intermediate (I) or resistant (R) to at least one agent in three or more antimicrobial classes, up to 6 months after discharge

The Cleveland Clinic

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

21-863

2022-11-01

2026-01-31

2026-06-30

2022-10-06

2023-03-07

Indian River Hospital, Vero Beach, Florida, 32960, United States|Weston Hospital/Cleveland Clinic Florida, Weston, Florida, 33331, United States|Akron General Hospital, Akron, Ohio, 44307, United States|Avon Hospital, Avon, Ohio, 44011, United States|Lutheran Hospital, Cleveland, Ohio, 44113, United States|Cleveland Clinic Main Campus, Cleveland, Ohio, 44195, United States|Euclid Hospital, Euclid, Ohio, 44119, United States|Fairview Hospital, Fairview Park, Ohio, 44111, United States|Marymount Hospital, Garfield Heights, Ohio, 44125, United States|Hillcrest Hospital, Mayfield Heights, Ohio, 44124, United States|Medina Hospital, Medina, Ohio, 44256, United States|South Pointe Hospital, Warrensville Heights, Ohio, 44122, United States

{ "Rapid Diagnostic Testing": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Pharmacist-led de-escalation": [ { "intervention_type": "OTHER" } ] }

NCT02140554

A Study Evaluating the Safety and Efficacy of bb1111 in Severe Sickle Cell Disease

https://clinicaltrials.gov/study/NCT02140554

COMPLETED

This is a non-randomized, open label, multi-site, single dose, Phase 1/2 study in approximately 50 adults and adolescents with severe SCD. The study will evaluate hematopoietic stem cell (HSC) transplantation (HSCT) using bb1111 (also known as LentiGlobin BB305 Drug Product for SCD).

NO

Sickle Cell Disease

GENETIC: bb1111

VOE-CR, Proportion of subjects achieving complete resolution of VOEs between 6 months and 18 months after drug product infusion, 6-18 months post-transplant

sVOE-CR, Proportion of subjects achieving complete resolution of severe vaso-occlusive events, between 6 months and 18 months after drug product infusion, 6-18 months post-transplant|Proportion of Subjects achieving Globin Response, Globin Response, defined as meeting the following criteria for a continuous period of at least 6 months after drug product infusion: 1. Weighted average HbAT87Q percentage of non-transfused total Hb ≥30% AND 2. Weighted average non-transfused total Hb increase of ≥3 g/dL compared to baseline total Hb OR weighted average non-transfused total Hb ≥10 g/dL, 6-24 months post-transplant|Change in the annualized number of vaso-occlusive events (VOEs) in the 24 months after drug product infusion compared to the 24 months prior to Informed Consent, Through Month 24 post-transplant|Change in the annualized number of severe VOEs in the 24 months after drug product infusion as compared to the 24 months prior to informed consent, Through Month 24 post-transplant|VOE-CR24, Proportion of subject achieving complete resolution of VOEs between 6 months and 24 months after drug product infusion, 6-24 months post-transplant|sVOE-CR24, Proportion of subjects achieving complete resolution of severe VOEs between 6 months and 24 months after drug product infusion, 6-24 months post-transplant|sVOE-75, Proportion of subjects achieving a 75% reduction in annualized severe VOEs in the 24 months after drug product infusion compared to the 24 months prior to Informed Consent, Through Month 24 post-transplant|Proportion of subjects who meet the definition of Globin Response at Month 24, Month 24 post-transplant|Duration of Globin Response, 6-24 months post-transplant|Weighted average non-transfused total Hb, Month 6, 12, 18, and 24 post-transplant|Weighted average HbS percentage of non-transfused total Hb, Month 6, 12, 18, and 24 post-transplant|Weighted average HbAT87Q percentage of non-transfused total Hb, Month 6, 12, 18, and 24 post-transplant|Weighted average HbS percentage of non-transfused total Hb ≤ 70%, ≤ 60%, ≤ 50%, Month 6, 12, 18, and 24 post-transplant|Weighted average non-HbS percentage of non-transfused total Hb, Month 6, 12, 18, and 24 post-transplant|Average and median of non-transfused total Hb over time, Through Month 24 post-transplant|Average and median of HbS percentage of non-transfused total Hb over time, Through Month 24 post-transplant|Average and median of HbAT87Q percentage of non-transfused total Hb over time, Through Month 24 post-transplant|Average and median of non-HbS percentage of non-transfused total Hb over time, Through Month 24 post-transplant|Change from baseline in hemolysis markers, Through Month 24 post-transplant|Change from baseline in markers of iron stores, Through Month 24 post-transplant|Change from baseline in annualized frequency and volume of packed red blood cell (pRBC) transfusions, 6 - 24 months post-transplant|Change from baseline in markers of stress erythropoiesis, Through Month 24 post-transplant|Change from baseline in renal function as measured by eGFR, Through Month 24 post-transplant|Change from baseline in cardiac-pulmonary function via echocardiogram (tricuspid regurgitant jet velocity [TRJV], LVEF), Through Month 24 post-transplant|Change from baseline in cardiac-pulmonary function via pulmonary function tests, Through Month 24 post-transplant|Change from baseline in meters walked during 6-minute walk test, Through Month 24 post-transplant|Change from baseline in annualized VOE-related hospital admissions, From post-transplant hospital discharge to Month 24 post-transplant|Change from baseline in annualized total days hospitalized, From post-transplant hospital discharge to Month 24 post-transplant|Change from baseline in patient-reported quality of life, as measured by Patient Reported Outcomes Measurement Information System (PROMIS), Month 3, 6, 12, 18, and 24 post-transplant

bluebird bio

ALL

CHILD, ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

HGB-206

2015-02-02

2023-07-31

2024-01-30

2014-05-16

2024-02-09

Birmingham, Alabama, United States|Oakland, California, United States|Atlanta, Georgia, 30322, United States|Chicago, Illinois, United States|Bethesda, Maryland, United States|Hackensack, New Jersey, United States|Hyde Park, New York, United States|New York, New York, United States|Chapel Hill, North Carolina, United States|Philadelphia, Pennsylvania, United States|Charleston, South Carolina, United States

{ "bb1111": [ { "intervention_type": "GENETIC" } ] }

NCT05616754

A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)

https://clinicaltrials.gov/study/NCT05616754

RECRUITING

The study was designed as a randomized, blind and controlled trial. A total of 300 patients aged 18 and above who were immunized with recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months (60 patients aged 60 and above) were randomly and blind divided into the experimental group and the control group, and received the experimental vaccine and the control vaccine, respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine.

NO

COVID-19

BIOLOGICAL: Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells)|BIOLOGICAL: Recombinant Novel Coronavirus Protein Vaccine (CHO cells)

Immunogenic end points, Geometric mean concentration (GMC) of RBD protein-binding Antibody (IgG) against Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group., 6 months

Immunogenic end points 2, RBD protein-bound antibody (IgG) growth ratio (GMI) and positive turnover rate for Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group;, 6 months|Immunogenic end points 3, RBD protein-binding antibody (IgG) GMC, GMI and positive turnover were detected against the primary COVID-19 strain and Delta variant 14 days after vaccination in experimental group., 6 months|Immunogenic end points 4, RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants 6 months after vaccination in the experimental group, 6 months|Immunogenic end points 5, RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants were detected 14 days after vaccination in the observation group, 6 months|Immunogenic end points 6, RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants in the observation group for 6 months, 6 months

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

ALL

CHILD, ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

LKM-2022-NCV-GJ01

2022-11-07

2023-07-30

2023-09-30

2022-11-15

2022-11-15

Uzbekistan, Tashkent city, Said baraka street 10, Tashkent, 100012, Uzbekistan

{ "Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells)": [ { "intervention_type": "BIOLOGICAL" } ], "Recombinant Novel Coronavirus Protein Vaccine (CHO cells)": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT03730454

Transanastomotic Tube for Proximal Esophageal Atresia With Distal Tracheoesophageal Fistula Repair

https://clinicaltrials.gov/study/NCT03730454

TEF

RECRUITING

This trial will compare the effectiveness of two common surgical practices for Type C esophageal atresia repair: esophageal atresia (EA) with distal tracheoesophageal fistula (TEF). Infants with EA/TEF requiring surgical intervention will be recruited. Subjects will be randomized to either repair with or without transanstomotic tube (TT) during esophageal anastomosis creation. Primary outcome is symptomatic anastomotic stricture development requiring dilation within 12 months.

NO

Esophageal Atresia|Tracheoesophageal Fistula

DEVICE: Transanastomotic Tube (5FR)|OTHER: No Transanastomotic Tube

Anastomotic stricture, Symptomatic anastomotic stricture requiring dilation, 12 months

Anastomotic Leak, Anastomotic leak seen radiographically or in the operating room, 12 months|Recurrent Fistula, Recurrent fistula seen radiographically or in the operating room, 12 months|Vocal cord injury, vocal cord injury seen radiographically or in the operating room, 12 months|Unplanned return to OR, Any unplanned return to opearting room, 12 months|Duration of perenteral nutrition, Days requrining TPN, 12 months|Length of Stay, Length of stay during hospitalization for primary repair, 12 months

Phoenix Children s Hospital

ALL

CHILD

OTHER

INTERVENTIONAL

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

17-136

2018-05-11

2025-02-14

2025-02-14

2018-11-05

2024-04-05

Phoenix Children s Hospital, Phoenix, Arizona, 85016, United States|Children s Hospital Los Angeles, Los Angeles, California, 90027, United States|Rady Children s Hospital, San Diego, California, 92123, United States|Benioff Children s Hospital, San Francisco, California, 94158, United States|Lucile Packard Children s Hospital, Stanford, California, 94305, United States|Children s Hospital Colorado, Aurora, Colorado, 80045, United States|Doernbecher Children s Hospital, Portland, Oregon, 97239, United States|Children s Medical Center, Dallas, Texas, 75235, United States|Primary Children s Hospital, Salt Lake City, Utah, 84113, United States|Seattle Children s Hospital, Seattle, Washington, 98105, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/54/NCT03730454/Prot_SAP_001.pdf

{ "Transanastomotic Tube (5FR)": [ { "intervention_type": "DEVICE" } ], "No Transanastomotic Tube": [ { "intervention_type": "OTHER" } ] }

NCT01987154

Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

https://clinicaltrials.gov/study/NCT01987154

COMPLETED

To evaluate the use of a hypoallergenic infant formula containing an extensively hydrolyzed protein source for routine nutrition.

NO

Feeding Intolerance

OTHER: Marketed cow milk-based premature infant formula|OTHER: Marketed extensively hydrolyzed casein infant formula

Enteral intake (ml/kg/day), Daily for 14 days

Body Weight (g), Daily for 14 days|Feeding Tolerance, Gastric residuals, regurgitation(>1 ml), fecal output (number of stools per day), Daily for 14 days|Respiratory status, Apnea and/or bradycardia events, use of supplemental oxygen, use of mechanical ventilation, Daily for 14 days|Gut Inflammation, Fecal calprotectin, alpha and beta defensins, TNF alpha, gastric ultrasound, Once at Study Day 14|Confirmed or suspected sepsis or necrotizing enterocolitis, Daily for 14 days|Date of hospital discharge, Once at hospital discharge|Growth, length (cm) and head circumference (cm), Study Days 1, 7, and 14

Mead Johnson Nutrition

ALL

CHILD, ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

6020

2014-02

2016-03

2016-03

2013-11-19

2016-05-17

Azienda Ospedaliera Ospedale Policlinico Consorziale di Bari, Bari, Apulia, 70124, Italy

{ "Marketed cow milk-based premature infant formula": [ { "intervention_type": "OTHER" } ], "Marketed extensively hydrolyzed casein infant formula": [ { "intervention_type": "OTHER" } ] }

NCT01056354

Respiratory Virus Outpatient Study (FLU 002 Plus)

https://clinicaltrials.gov/study/NCT01056354

COMPLETED

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded

NO

Influenza and Other Novel Respiratory Viruses

Death or Hospitalization, Death or hospitalization within 14 days of enrollment or the development of one severe complication., 14-day period following enrollment

Days of work/school lost, duration of symptoms, use of antivirals, 14 days

University of Minnesota

National Institute of Allergy and Infectious Diseases (NIAID)|National Institutes of Health (NIH)

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

0603M83587 FLU 002|HHSN261200800001E ; 29XS214

2009-08

2017-05-12

2017-05-12

2010-01-26

2017-08-18

UCSD Antiviral Research Center, San Diego, California, 92103-8208, United States|Denver Public Health, Denver, Colorado, 80204, United States|George Washington Medical Faculty Associates, Washington, D.C., District of Columbia, 20037, United States|Washington DC VA Medical Center, Washington, D.C., District of Columbia, 20422, United States|Infectious Diseases Associates NW FL, PA, Pensacola, Florida, 32503, United States|University of Illinois at Chicago, Chicago, Illinois, 60612, United States|Henry Ford Health System, Detroit, Michigan, 48202, United States|Newland Immunology Center of Excellence (NICE), Southfield, Michigan, 48075, United States|New Jersey Medical School Adult Clinical Research Center, Newark, New Jersey, 07103, United States|Cornell CRS, New York, New York, 10010, United States|Bronx-Lebanon Hospital Center, The Bronx, New York, 10457, United States|UNC AIDS Clinical Trials Unit, Chapel Hill, North Carolina, 27514, United States|Duke University, Durham, North Carolina, 27710, United States|University of Tennessee College of Medicine, Chattanooga, Tennessee, 37403, United States|University of North Texas Health Science Center, Fort Worth, Texas, 76107, United States|Houston AIDS Research Team, Houston, Texas, 77030, United States|Virginia Commonwealth University, Richmond, Virginia, 23298, United States|Hospital Nacional Profesor Alejandro Posadas, El Palomar, Buenos Aires, Argentina|Hospital Interzonal General de Agudos Dr. Diego Paroissien, La Matanza, Buenos Aires, Argentina|Instituto Medico Platense, La Plata, Buenos Aires, Argentina|Hospital Profesor Bernardo Houssay, Vicente Lopez, Buenos Aires, Argentina|CAICI (Instituto Centralizado de Assistencia e Investigacion Clinica Integral), Rosario, Santa Fe, Argentina|Sanatorio Britanico, Rosario, Santa Fe, Argentina|CEMIC, Buenos Aires, Argentina|FUNCEI, Buenos Aires, Argentina|Hospital General de Agudos JM Ramos Mejia, Buenos Aires, Argentina|Hospital Italiano de Buenos Aires, Buenos Aires, Argentina|Hospital Privado Centro Medico de Cordoba, Cordoba, Argentina|Hospital Rawson, Cordoba, Argentina|Interchange General Practice, Canberra, Australian Capital Territory, 2601, Australia|Holdsworth House Medical Practice, Darlinghurst, New South Wales, 2010, Australia|Westmead Hospital, Westmead, New South Wales, 2145, Australia|Prahran Market Clinic, Melbourne, Victoria, 3181, Australia|Northside Clinic, North Fitzroy, Victoria, 3068, Australia|Centre Hospitalier Universitaire St. Pierre (C.H.U. St. Pierre), Brussels, Belgium|Practimed Medisch Centrum Tessenderlo, Tessenderlo, Belgium|Clinica Alemana, Santiago, Chile|Fundacion Arriaran, Santiago, Chile|Pontificia Universidad Catolica de Chile, Santiago, Chile|Arhus Universitetshospital, Skejby, Aarhus, Denmark|CHIP, Copenhagen, Denmark|Rigshospitalet, Infektionsmedicinsk ambulatorium 8622, Copenhagen, Denmark|University Clinic of General Practice, Copenhagen, Denmark|West Tallinn Central Hospital Infectious Diseases, Tallinn, Estonia|Medizinische Universitatsklinik - Bonn, Immunologische Ambulanz CRS, Bonn, Germany|Klinik I fur Innere Medizin der Universitat zu Koln, Studienburo fur Infektiologie u. HIV, Cologne, Germany|Johann Wolfgang Goethe - University Hospital, Infektionsambulanz CRS, Frankfurt, Germany|Ifi - Studien und Projekte GmbH, Hamburg, Germany|1st Dept of Critical Care Medicine and Pulmonary Services, Evangelismos Hospital, Athens, Greece|1st Respiratory Medicine Dept, Athens Hosp for Diseases of the Chest Sotiria Hospital , Athens, Greece|Evangelismos General Hospital, Athens, Greece|Hippokration University General Hospital of Athens, Athens, Greece|National Hospital Organization Nagoya Medical Center, Nagoya, 460-0001, Japan|Hospital Nacional Arzobispo Loayza, Lima, 01, Peru|Asociacion Civil IMPACTA Salud y Educacion, Lima, 04, Peru|Hospital Nacional Edgardo Rebagliati Martins, Lima, 11, Peru|Hospital Nacional Guillermo Almenara Irigoyen, Lima, 13, Peru|Wojewodzki Szpital Zakazny, Warsaw, Poland|EMC Instytut Medyczny SA, Wroclaw, Poland|Hospital Universitario y Politécnico La Fe, Valencia, 46026, Spain|Hospital Txagorritxu, Vitoria-Gasteiz, Spain|Chulalongkorn University Hospital, Bangkok, 10330, Thailand|Khon Kaen University, Srinagarind Hospital, Khon Kaen, 40002, Thailand|Bamrasnaradura Institute, Nonthaburi, 11000, Thailand|Norfolk and Norwich University Hospital, Norwich, Norfolk, NR4 7UY, United Kingdom|Churchill Hospital, Headington, Oxford, OX3 9LJ, United Kingdom|Bradford Teaching Hospitals NHS Foundation Trust, Bradford, West Yorkshire, BD9 6RJ, United Kingdom|St James s University Hospital, Leeds, West Yorkshire, LS9 7TF, United Kingdom

{}

NCT06037954

A Study of Mental Health Care in People With Cancer

https://clinicaltrials.gov/study/NCT06037954

RECRUITING

The purpose of this study is to look at mental health services for adults with depressed mood who were diagnosed with cancer at the age of 65 or older. This study will compare the usual approach for connecting older adults with depressed mood to mental health services with the Open Door for Cancer (OD-C) approach. We will find out if the OD-C approach is practical and useful for cancer patients who participate in the intervention and for providers who see or treat cancer patients.

NO

Breast Cancer|Colorectal Cancer|Lung Cancer|Prostate Cancer

OTHER: Questionnaires|OTHER: Interviews|OTHER: 30-minute telephone or videoconference sessions

Refusal rates, ≥75% of eligible patients enroll in the study, 2 years|Attrition rates, ≥80% of patients who enroll complete all study procedures, 2 years

Treatment satisfaction, Client Satisfaction Questionnaire-8 mean score of ≥3, 2 years

Memorial Sloan Kettering Cancer Center

Weill Medical College of Cornell University

ALL

OLDER_ADULT

OTHER

INTERVENTIONAL

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

23-218

2023-09-07

2026-09

2026-09

2023-09-14

2023-09-14

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

{ "Questionnaires": [ { "intervention_type": "OTHER" } ], "Interviews": [ { "intervention_type": "OTHER" } ], "30-minute telephone or videoconference sessions": [ { "intervention_type": "OTHER" } ] }

NCT04931654

A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer

https://clinicaltrials.gov/study/NCT04931654

RECRUITING

This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.

NO

Carcinoma, Non-Small-Cell Lung|Gastric Cancer|Gastroesophageal Junction Cancer

DRUG: AZD7789

Number of participants with adverse events (AE), serious adverse events (SAE) and immune-mediated AEs (imAE), Number of participants with AEs, SAEs, imAEs including AEs leading to discontinuation of study intervention and clinically significant alterations in vital signs, laboratory parameters and ECG results, From time of Informed Consent to 90 days post last dose of study intervention|Number of participants with dose-limiting toxicity (DLT), as defined in the protoocol, A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness., From the first patient until the end of the dose escalation period; approximately 18 months.|Preliminary anti-tumour activity of AZD7789, Objective response rate as defined by RECIST v1.1, From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.

Objective response rate, Objective response rate as defined by RECIST v1.1, From first participant until last participant assessment; a duration of approximately 4 years. Disease assessments will be performed until progression or initiation of another anticancer therapy.|Disease control rate, The percentage of participants according to RECIST v1.1 with a response or stable disease, From first documented response to confirmed progressive disease or death; approximate duration of 4 years.|Duration of response, The time from first response according to RECIST v1.1 until progression or death, From first documented response to confirmed progressive disease or death; approximate duration of 4 years.|Progression-free survival, The time from first dose of study intervention until the date of objective disease progression or death, From first dose of study intervention to confirmed progressive disease or death; approximate duration of 4 years.|Overall survival, The time from first dose of study intervention until death due to any cause, From first dose of study intervention to death. Overall survival will be monitored for the duration of the study, which will last approximately 4 years.|Pharmacokinetics of AZD7789: Maximum plasma concentration of the study drug (Cmax), Maximum observed plasma concentration of the study drug., From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.|Immunogenicity of AZD7789, The number and percentage of participants who develop detectable anti-drug antibodies (ADA)., From first dose of study intervention, at predefined intervals throughout the administration of study intervention. A duration of approximately 4 years.|Pharmacokinetics of AZD7789: Area Under the concentration-time curve (AUC), Area under the plasma concentration-time curve., From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.|Pharmacokinetics of AZD7789: Clearance, A pharmacokinetic measurement of the volume of plasma from which the study drug is completely removed per unit time., From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.|Pharmacokinetics of AZD7789: Terminal elimination half-life (t 1/2), Terminal elimination half life., From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.|Preliminary anti-tumour activity of AZD7789: Changes in circulating tumor DNA (ctDNA), Changes in ctDNA between baseline and on treatment., From first dose of study intervention, at predefined intervals throughout the administration of study intervention; approximately 4 years.

AstraZeneca

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

D9570C00001|152970|2021-000036-57

2021-09-28

2025-07-29

2025-07-29

2021-06-18

2024-06-21

Research Site, Atlanta, Georgia, 30322, United States|Research Site, Fort Wayne, Indiana, 46804, United States|Research Site, New York, New York, 10029, United States|Research Site, Nashville, Tennessee, 37203, United States|Research Site, Edmonton, Alberta, T6G 1Z2, Canada|Research Site, Toronto, Ontario, M5G 2M9, Canada|Research Site, Beijing, 100142, China|Research Site, Guangzhou, 510060, China|Research Site, Bordeaux, 33076, France|Research Site, Marseille, 13385, France|Research Site, Rennes, 35000, France|Research Site, Villejuif Cedex, 94805, France|Research Site, Tbilisi, 0112, Georgia|Research Site, Chuo-ku, 104-0045, Japan|Research Site, Kashiwa, 277-8577, Japan|Research Site, Sendai-shi, 980-0873, Japan|Research Site, Chisinau, MD-2025, Moldova, Republic of|Research Site, Amsterdam, 1066 CX, Netherlands|Research Site, Barcelona, 08035, Spain|Research Site, Madrid, 28027, Spain|Research Site, Adana, 01060, Turkey|Research Site, Ankara, 06010, Turkey|Research Site, Ankara, 06200, Turkey|Research Site, Ankara, 06800, Turkey|Research Site, Bornova-Izmir, 35100, Turkey|Research Site, Edirne, 22030, Turkey|Research Site, Istanbul, 34722, Turkey|Research Site, Karsiyaka, 35575, Turkey

{ "AZD7789": [ { "intervention_type": "DRUG" } ] }

NCT05334654

Bivalirudin Versus Enoxaparin in Critically Ill COVID-19 Patients

https://clinicaltrials.gov/study/NCT05334654

COMPLETED

Coronavirus Disease (COVID-19) is characterized by a hypercoagulable state, sometimes difficult to be managed with heparin. Bivalirudin, a member of the direct thrombin inhibitor drug class, offers potential advantages compared to heparin, including to its ability to exert its effect by directly attaching to and inhibiting freely circulating and fibrin-bound thrombin. Investigators have therefore designed this pilot open-label randomized controlled trial to assess if a off-label infusion of bivalirudin may reduce thrombosis, mortality, Intensive Care Unit (ICU) length of stay and increase ventilator free days of patients admitted in ICU for acute respiratory failure due to COVID-19, as compared to first-line treatment with heparin.

NO

Acute Respiratory Failure|SARS CoV 2 Infection|Anticoagulants

DRUG: Enoxaparin Sodium|DRUG: Bivalirudin

Time spent under invasive mechanical ventilation, number of days that patient would require invasive mechanical ventilation, from randomization till 28 days after randomization

Incidence of vein thrombosis and embolism, Number of patients with diagnosis of deep vein thrombosis and/or pulmonary embolism, from randomization till 28 days after randomization or ICU discharge|Gas Exchange, Daily evaluation of oxygenation through arterial blood gases, Every day till 28 days after randomization or ICU discharge|Intensive Care Unit length of stay, Number of days spent in Intensive Care Unit, Up to 1 year|Intensive Care Unit mortality, Number of patients died during the Intensive Care Unit stay, Up to 1 year

University Magna Graecia

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

Bivalirudin COVID-19

2022-04-20

2022-06-30

2022-07-30

2022-04-19

2022-08-19

AOU Mater Domini, Catanzaro, Italy

{ "Enoxaparin sodium": [ { "intervention_type": "DRUG", "description": "Enoxaparin Sodium", "name": "Enoxaparin sodium", "synonyms": [ "Clexane", "Enoxaparin sodium", "Xaparin", "Lovenox" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Enoxaparin%20sodium", "generic_names": [] } ], "Bivalirudin": [ { "intervention_type": "DRUG", "description": "Bivalirudin", "name": "Bivalirudin", "synonyms": [ "Bivalirudin", "Bivalirudinum", "Bivalirudina" ], "drugbank_id": "DB00006", "generic_names": [ "Bivalirudin" ] } ] }

NCT04561154

Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV

https://clinicaltrials.gov/study/NCT04561154

REPERCOV

UNKNOWN

Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019). It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care. Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured. In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection. The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.

NO

SARS-COV2|COVID19

OTHER: questionnaire

Identify functionnal and psychosocial complaints, the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire Modified Medical Research Council , 3 months after last hospitalization|Identify functionnal and psychosocial complaints, the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire Medical Outcome Study Short Form 36 (MOS SF-36) , 3 months after last hospitalization|Identify functionnal and psychosocial complaints, the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by FRIED criteria, 3 months after last hospitalization|Identify functionnal and psychosocial complaints, the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire Hospital Anxiety and Depression Scale (HADS) , 3 months after last hospitalization

description of functionnal and psychosocial complaints, complaints will be assessed by questionnaire Modified Medical Research Council , 3 months after last hospitalization|description of functionnal and psychosocial complaints, complaints will be assessed by questionnaire Medical Outcome Study Short Form 36 (MOS SF-36) , 3 months after last hospitalization|description of functionnal and psychosocial complaints, complaints will be assessed by FRIED criteria, 3 months after last hospitalization|description of functionnal and psychosocial complaints, complaints will be assessed by questionnaire Hospital Anxiety and Depression Scale (HADS) , 3 months after last hospitalization|Identify the factors favoring the persistence of complaints, Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization, 3 months after last hospitalization|Describe functional, neuropsychological and social complaints at a distance, Complaints will be assessed by questionnaire Modified Medical Research Council , 3 months after last hospitalization|Describe functional, neuropsychological and social complaints at a distance, Complaints will be assessed by questionnaire Medical Outcome Study Short Form 36 (MOS SF-36) , 3 months after last hospitalization|Describe functional, neuropsychological and social complaints at a distance, Complaints will be assessed by FRIED criteria, 3 months after last hospitalization|Describe functional, neuropsychological and social complaints at a distance, Complaints will be assessed by questionnaire Hospital Anxiety and Depression Scale (HADS) , 3 months after last hospitalization|Describe the needs for medical and surgical consultations after discharge from hospital, Medical and surgical consultations after discharge will be measured as percentage, 3 months after last hospitalization|Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital., neuropsychological support, dietetics, social assistance after discharge will be measured as percentage, 3 months after last hospitalization|Describe the factors of inequalities in access to care, Describe the factors of inequalities in access to care and study their impact on the occurrence of a SARS-CoV-2 infection, its severity and the occurrence of a functional or psycho-social complaint., 3 months after last hospitalization

Centre Hospitalier le Mans

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

CHM-2020/S10/04

2020-06-11

2021-06-11

2022-06-11

2020-09-23

2022-03-09

Centre Hospitalier du Mans, Le Mans, 72000, France

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

NCT02639533

Brain Response to Single Dose of Pregabalin in Fibromyalgia

https://clinicaltrials.gov/study/NCT02639533

COMPLETED

Fibromyalgia syndrome represents a spectrum disorder characterized by widespread chronic pain, fatigue, sleep disturbances, mood and cognitive alterations. The most accepted models explaining the causes of the disease have focused on the reduced pain inhibitory systems activity, that allow low intensity stimuli to be processed easier, and that finally amplify pain stimuli. One of the interventions approved for Fibromyalgia is Pregabalin, which demonstrated to be effective reducing pain. Different studies in animals have shown that it works reducing the liberation of neuronal messengers, which slow the conduction of pain signals. Although studies in humans have confirmed Pregabalin clinical benefits, there are still few studies aiming to explain how it actually works in patients with fibromyalgia, though. A better understanding of the mechanisms by which Pregabalin reduces pain in patients with fibromyalgia would allow designing new interventions to enhance its clinical effects. Thus, the investigators propose to study in real-time the electrical, vascular and hormonal response of the brain of patients with fibromyalgia who receive a single dose of Pregabalin. The vascular response will be assessed using functional near infrared spectroscopy (fNIRS) neuroimaging techniques. The electrical response will be assessed using Transcranial Magnetic Stimulation (TMS). The hormonal response will be assessed in blood, measuring neurotrophins (Brain Derived Neurotrophic Factor) and inflammatory mediators (Tumor Necrosis Factor). These responses will be studied in consideration of the patients characteristics that will be assessed using validated scales. Taken into account the above considerations, a crossover, double-blinded randomized clinical trial is proposed. In the investigators study, patients and healthy volunteers will be asked to visit the investigators laboratory in three opportunities: one for a baseline assessment, and the other two to test the effects of either Pregabalin 150 mg PO or Placebo. All participants will eventually receive both, Pregabalin and Placebo. In each visit a brain hemodynamic, electrical, hormonal and clinical evaluation will be performed.

NO

Fibromyalgia

DRUG: Pregabalin|OTHER: Placebo

Cortical Excitability: Intracortical Inhibition., Cortical excitability parameters assessed non-invasively using paired-pulse Transcranial Magnetic Stimulation. Intracortical inhibition will be assessed using a conditioning stimuli of 80% of the motor threshold (MT) and a testing pulse of 120% the of the MT, with interstimuli interval (isi) of 2 and 4 microseconds. The Intracortical Inhibition corresponds to the ratio between the resultant potential and the motor evoked potential., 1 hour after intervention|Cortical hemodynamics: Oxy-hemoglobin concentration (mM/L), Cortical hemodynamics assessed non-invasively using functional near infrared spectroscopy. Thanks to spectroscopy principles, it is possible to safety use a light beam in the infrared spectrum to infer the concentration of hemoglobin when bonded to oxygen. Its concentration is calculated in mM/L., 1 hour after intervention

Pain, Assessed with the Visual Analog Scale, 1 hour after intervention|Heat Pain Threshold, Assessed using quantitative sensory testing. Briefly, a thermode placed in subjects forearm is heated controlled by a computer. Subjects are instructed to report when perceiving the first pain. Temperatures in Celcius degrees are recorded., 1 hour after intervention|Pressure Pain Threshold, Assessed using a digital algometer. Briefly, progressive pressure is applied in subjects forearm until the first perception of pain is reported. The pressure of the first perception of pain are recorded in Kg/cm^2 ., 1 hour after intervention|Maximal Heat Pain Tolerance, Assessed using quantitative sensory testing. Briefly, the thermode placed in subjects forearm is heated until subject reports maximum tolerated pain. A maximal temperature of 52 Celcius has been previously programmed for the device to stop and cool down in order to avoid unintended injuries., 1 hour after intervention|Conditioned pain modulation, The protocol for heat pain threshold is repeated while the contralateral hand is placed on iced water. The pain due to heat and cold reported on a Visual Analog Scale are recorded., 1 hour after intervention|Serum Brain Derived Neurotrophic Factor (BDNF), Blood samples will be gathered at baseline and 2 hours after receiving the intervention to quantify the serum BDNF concentration (ng/mL)., Baseline and 2 hours after intervention|Serum Protein S100B, Blood samples will be gathered at baseline and 2 hours after receiving the intervention to quantify the serum S100B concentration (pg/mL)., Baseline and 2 hours after intervention

Hospital de Clinicas de Porto Alegre

Conselho Nacional de Desenvolvimento Científico e Tecnológico|Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.|Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

FEMALE

ADULT, OLDER_ADULT

PHASE2|PHASE3

OTHER

INTERVENTIONAL

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

14-0624

2014-12

2017-01

2017-01

2015-12-24

2018-02-08

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

NCT03583333

Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Piperacillin/Tazobactam in Participants With Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia (MK-7655A-016)

https://clinicaltrials.gov/study/NCT03583333

COMPLETED

This study will evaluate the efficacy and safety of a FDC of imipenem/cilastatin (IMI) and relebactam (REL) [IMI/REL, MK-7655A] compared to piperacillin/tazobactam (PIP/TAZ) in the treatment of adults diagnosed with Hospital-Acquired Bacterial Pneumonia (HABP) or Ventilator-Associated Bacterial Pneumonia (VABP). The primary hypothesis is that IMI/REL is non-inferior to PIP/TAZ as measured by the incidence rate of all-cause mortality through Day 28 post-randomization.

YES

Hospital-Acquired Bacterial Pneumonia|Ventilator-Associated Bacterial Pneumonia

DRUG: IMI/REL FDC|DRUG: PIP/TAZ FDC|DRUG: Linezolid

Percentage of Participants With All-cause Mortality Through Day 28 in the Modified Intent to Treat (MITT) Population, For each participant, survival status was assessed at Day 28 post-randomization and recorded on the electronic Case Report Form. The percentage of participants with all-cause mortality through Day 28 in the MITT population is presented., Up to approximately 28 days

Percentage of Participants Achieving a Favorable Clinical Response at Early Follow-up (EFU) Visit in the MITT Population, Clinical response was defined as Sustained cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence AND no additional antibiotic therapy was required for the index infection) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EFU visit in the MITT population is presented., Up to approximately 27 days|Percentage of Participants Achieving a Favorable Clinical Response at EFU Visit in the Clinically Evaluable (CE) Population, Clinical response was defined as Sustained cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status with no evidence of resurgence) AND no additional antibiotic therapy was required for the index infection or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy was required for the index infection. The percentage of participants achieving a favorable clinical response at EFU visit in the CE population is presented., Up to approximately 27 days|Percentage of Participants Achieving a Favorable Clinical Response at End of Therapy (EOT) Visit in the MITT Population, Clinical response was defined as Improved (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to pre-infection status AND no additional antibiotic therapy was required) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status AND no additional antibiotic therapy was required for the index infection). The percentage of participants achieving a favorable clinical response at EOT visit in the MITT population is presented., Up to approximately 14 days|Percentage of Participants Achieving a Favorable Clinical Response at EOT Visit in the Clinically Evaluable (CE) Population, Clinical response was defined as Improved (The majority of pre-therapy signs and symptoms of the index infection have improved or resolved or returned to pre-infection status AND no additional antibiotic therapy is required) or Cure (All pretherapy signs and symptoms of the index infection have resolved or returned to preinfection status) AND no additional antibiotic therapy is required for the index infection. The percentage of participants achieving a favorable clinical response at End of Treatment (EOT) visit in the CE population is presented., Up to approximately 14 days|Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in Microbiological Modified Intent-To-Treat Population (mMITT) Population, Favorable overall microbiological response rates were defined as eradication (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EOT visit in the mMITT population is presented., Up to approximately 14 days|Percentage of Participants Achieving a Favorable Microbiological Response at EFU Visit in Microbiological-evaluable (ME) Population., A favorable by-pathogen microbiological response at EFU visit required eradication (A lower respiratory tract culture taken at the EFU visit showed eradication of the pathogen found at study entry) or presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at EFU visit in the ME population is presented., Up to approximately 27 days|Percentage of Participants Achieving a Favorable Microbiological Response at EOT Visit in the ME Population, Favorable overall microbiological response rates was defined as eradication (A lower respiratory tract culture taken at the EOT visit showed eradication of the pathogen found at study entry) OR presumed eradication (No specimen taken because participant was deemed clinically cured or improved) of the baseline pathogen. The percentage of participants achieving a favorable microbiological response at End of Treatment (EOT) visit in the ME population is presented., Up to approximately 14 days|Percentage of Participants Experiencing Adverse Events (AEs), An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants experiencing an AE was reported for each arm., Up to approximately 98 days|Percentage of Participants Discontinuing Study Drug Due to AEs, An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants that discontinued study therapy due to an AE was reported for each arm., Up to approximately 14 days

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

7655A-016|MK-7655A-016|PHRR190814-002177|2018-003202-82

2018-09-18

2022-07-12

2022-07-12

2018-07-11

2023-06-28

2023-06-28

Santa Casa de Misericordia de Belo Horizonte ( Site 0300), Belo Horizonte, Minas Gerais, 30150-221, Brazil|Hospital de Base de Sao Jose de Rio Preto ( Site 0301), Sao Jose Do Rio Preto - SP, Sao Paulo, 15090-000, Brazil|Beijing Chaoyang Hospital ( Site 0126), Beijing, Beijing, 100020, China|Peking University First Hospital ( Site 0131), Beijing, Beijing, 100034, China|Aero Space center hospital ( Site 0118), Beijing, Beijing, 100049, China|The Seventh Medical Center of PLA General Hospital-Intensive medicine ( Site 0157), Beijing, Beijing, 100073, China|Peking University Third Hospital ( Site 0115), Beijing, Beijing, 100191, China|Beijing Hospital ( Site 0127), Beijing, Beijing, 100730, China|The First Affiliated Hospital Of Fujian Medical University-Respiratory ( Site 0136), Fuzhou, Fujian, 350005, China|Zhongshan Hospital Affiliated to Xiamen University ( Site 0133), Xiamen, Fujian, 361004, China|Zhangzhou Municipal Hospital of Fujian Province-Neurosurgery Department ( Site 0150), Zhangzhou, Fujian, 363000, China|The First Affiliated Hospital ( Site 0100), GuangZhou, Guangdong, 510080, China|The First Affiliated Hospital of Guangzhou Medical University ( Site 0123), Guangzhou, Guangdong, 510120, China|Guangzhou First People s Hospital ( Site 0101), Guangzhou, Guangdong, 510180, China|Zhujiang Hospital of Southern Medical University ( Site 0148), Guangzhou, Guangdong, 510280, China|Southern Medical University Nanfang Hospital ( Site 0120), Guangzhou, Guangdong, 510515, China|Huizhou Municipal Central Hospital ( Site 0140), Huizhou, Guangdong, China|Shenzhen People s Hospital ( Site 0134), Shenzhen, Guangdong, 518020, China|The first people s hospital of Nanning ( Site 0138), Nanning, Guangxi, 530022, China|The first people s hospital of Nanning ( Site 0141), Nanning, Guangxi, 530022, China|Hainan General Hospital ( Site 0106), Haikou, Hainan, 570311, China|The First Affiliated Hospital of Zhengzhou University ( Site 0121), Zhengzhou, Henan, 450052, China|Shiyan City People s Hospital-Neurosurgery ( Site 0155), Shiyan, Hubei, 442000, China|Changsha Central Hospital ( Site 0119), Changsha, Hunan, 410004, China|Hunan Provincial People Hospital ( Site 0122), Changsha, Hunan, 410005, China|The First People s Hospital of Changzhou ( Site 0139), Changzhou, Jiangsu, 213003, China|First Huai an Hospital Affiliated to Nanjing Medical University-Neurosurgery Department ( Site 0153), Huai an, Jiangsu, 223300, China|First Hospital Affiliated to Suzhou University ( Site 0111), Suzhou, Jiangsu, 215008, China|Wuxi People s Hospital ( Site 0124), Wuxi, Jiangsu, 214023, China|Affiliated Hospital of Jiangsu University ( Site 0147), Zhenjiang, Jiangsu, 212000, China|Jiangxi Provincial People s Hospital ( Site 0129), Nanchang, Jiangxi, 330006, China|The First Affiliated Hospital of Nanchang University ( Site 0132), Nanchang, Jiangxi, 330006, China|The Second Affiliated Hospital of Nanchang University-Neurosurgery Department ( Site 0151), Nanchang, Jiangxi, 330006, China|The First Affiliated Hospital of China Medical University ( Site 0116), Shenyang, Liaoning, 110001, China|General Hospital of Ningxia Medical University ( Site 0135), Yinchuan, Ningxia, 750004, China|People s Hospital of Liaocheng City-Neurology ( Site 0154), Liaocheng, Shandong, 252000, China|Ruijin Hospital Shanghai Jiao Tong University School of Medicine ( Site 0104), Shanghai, Shanghai, 200025, China|Huadong Hospital Affiliated Fudan University ( Site 0103), Shanghai, Shanghai, 200040, China|Huashan Hospital of Fudan University ( Site 0105), Shanghai, Shanghai, 200040, China|Shanghai General Hospital ( Site 0125), Shanghai, Shanghai, 200080, China|Shanghai Pulmonary Hospital ( Site 0108), Shanghai, Shanghai, 200443, China|Tianjin Medical University General Hospital ( Site 0113), Tianjin, Tianjin, 300052, China|The First Affiliated Hospital.Zhejiang University ( Site 0102), Hangzhou, Zhejiang, 310003, China|Sir Run Run Shaw Hospital School of Medicine Zhejiang University ( Site 0110), Hangzhou, Zhejiang, 310016, China|People s Hospital of Lishui City ( Site 0137), Lishui, Zhejiang, 323000, China|Ningbo First Hospital-neurosurgery ( Site 0152), Ningbo, Zhejiang, 315010, China|The 2nd Affiliated Hospital of Wenzhou Medical University ( Site 0130), Wenzhou, Zhejiang, 325000, China|Hopital Roger Salengro du Lille ( Site 0601), Lille, Nord, 59037, France|CHU de Nantes - Hotel Dieu ( Site 0600), Nantes, Pays-de-la-Loire, 44093, France|Hospices Civils de Lyon ( Site 0603), Pierre Benite, Rhone, 69495, France|Hopital Bicetre ( Site 0605), Le Kremlin-Bicetre, Val-de-Marne, 94270, France|Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 0800), Guadalajara, Jalisco, 44280, Mexico|Hospital Civil Nuevo de Guadalajara Dr. Juan I. Menchaca ( Site 0804), Guadalajara, Jalisco, 44340, Mexico|Mary Johnston Hospital ( Site 0901), Metro Manila, National Capital Region, 1012, Philippines|Lung Center of the Philippines ( Site 0903), Quezon, National Capital Region, 1104, Philippines|West Visayas State University Medical Center ( Site 0900), Iloilo, 5000, Philippines|Spitalul Clinic Judetean de Urgenta Pius Branzeu ( Site 1103), Timisoara, Timis, 300723, Romania|Spitalul Clinic de Urgenta Bagdasar-Arseni ( Site 1101), Bucuresti, 041915, Romania|First City Clinical Hospital n.a. E.E.Volosevich ( Site 1016), Arkhangelsk, Arkhangel Skaya Oblast, 163001, Russian Federation|City Hospital #2 Severodvinsk ( Site 1017), Severodvinsk, Arkhangel Skaya Oblast, 164500, Russian Federation|Research Institute of Emergency Medicine n.a. I.I.Dzhanelidze ( Site 1011), Saint Petersburg, Sankt-Peterburg, 192242, Russian Federation|Clinical Hospital #122 L.G. Sokolova FMBA ( Site 1015), Saint Petersburg, Sankt-Peterburg, 194291, Russian Federation|City Hospital #26 ( Site 1002), Saint-Petersburg, Sankt-Peterburg, 196247, Russian Federation|ME Dnipropetrovsk Clinical Joinder of Emergency Care of DRC ( Site 1304), Dnipro, Dnipropetrovska Oblast, 49006, Ukraine|Ivano-Frankivsk regional clinical hospital ( Site 1301), Ivano-Frankivsk, Ivano-Frankivska Oblast, 76008, Ukraine|City Clinical Hospital No13 of Kharkiv City Council ( Site 1303), Kharkiv, Kharkivska Oblast, 61124, Ukraine|Kiyv city municipal hospital 17 ( Site 1300), Kiev, Kyivska Oblast, 01133, Ukraine|Reg. Clin. Hospital ( Site 1306), Poltava, Poltavska Oblast, 36000, Ukraine

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT03583333/Prot_SAP_000.pdf

{ "IMI/REL FDC": [ { "intervention_type": "DRUG" } ], "PIP/TAZ FDC": [ { "intervention_type": "DRUG" } ], "Linezolid": [ { "intervention_type": "DRUG", "description": "Linezolid", "name": "Linezolid", "synonyms": [ "Zyvoxid", "N-((3-(3-fluoro-4-morpholinylphenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide", "U100766", "PNU-100766", "100766, U", "Linezolid", "U 100766", "PNU100766", "U-100766", "Zyvox", "N-(((S)-3-(3-Fluoro-4-morpholinophenyl)-2-oxo-5-oxazolidinyl)methyl)acetamide", "Linezolide", "Linezolidum", "PNU 100766" ], "medline_plus_id": "a612002", "generic_names": [ "Linezolid" ], "mesh_id": "D011500", "drugbank_id": "DB00601", "wikipedia_url": "https://en.wikipedia.org/wiki/Linezolid" } ] }

NCT03842033

Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients

https://clinicaltrials.gov/study/NCT03842033

PEAKmAAP

ACTIVE_NOT_RECRUITING

The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.

NO

Pediatric Asthma

BEHAVIORAL: PEAKmAAP|BEHAVIORAL: PEAKmAAP-DS|BEHAVIORAL: NutriMap Usual Care

Change in Asthma Control Test (ACT) Score, ACT is a validated five question survey that computes a number indicating asthma control. The instrument range is 1-25, with 25 indication well controlled asthma. A score of less than or equal 19 is considered poorly controlled asthma. We plan to prospectively assess clinical outcomes including (ACT) score, Composite Asthma Severity Index (CASI) score, acute healthcare utilization, medication use, and lung function., 12 months|Composite Asthma Severity Index (CASI) score, The CASI quantify disease severity by looking at impairment risk and the amount of medication needed to maintain control. The CASI includes the major domains of asthma namely, impairment, as measured by day and night symptoms, along with albuterol use; and risk measured by forced expiratory volume in one second (FEV1) percent predicted and past asthma exacerbations, both of which are important predictors of future exacerbations., 12 months|Healthcare Utilization, We plan to utilize the PedsQOL instrument to measure participant quality of life. The PedQOL is a modular approach to measuring health related quality of life in children and adolescents with acute chronic health conditions. The instrument has a disease specific module for asthma. The instrument access four scales: physical functioning, emotional functioning, social functioning and school functioning., 3 months

Mediators of Asthma Control, Medication adherence and asthma self-efficacy. Pharmacy profiles will be accessed to determine medication adherence. We plan to administer the Pediatric Quality of Life (PedsQOL) to determine asthma self-efficacy. We plan to evaluate if participants are more likely to receive step up therapy per the national asthma guidelines., 12 months

Arkansas Children s Hospital Research Institute

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

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

206110|1R01NR015988-01A1

2019-03-04

2024-06-01

2024-12-30

2019-02-15

2024-02-05

Arkansas Children s Hospital Research Institute, Little Rock, Arkansas, 72202, United States

{ "PEAKmAAP": [ { "intervention_type": "BEHAVIORAL" } ], "PEAKmAAP-DS": [ { "intervention_type": "BEHAVIORAL" } ], "NutriMap Usual Care": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05121233

Local Anesthesia Versus Combined Local Anesthesia With Single Dose Analgesia on Pain Control During Thoracic Ultrasound Guided Procedures

https://clinicaltrials.gov/study/NCT05121233

UNKNOWN

This study aims to evaluate the efficacy of single dose analgesia in combination with local anesthesia to control pain during Trans Ultrasound guided procedures. It also aims to assess the effect of its use on procedure performance time and rate of complications occurrence compared to local anesthesia alone.

NO

Pleural Neoplasms|Aspiration, Respiratory|Pleural Effusion|Lung Neoplasms|Pneumothorax|Pyothorax

DRUG: Diclofenac|DRUG: Placebo

Pain intensity assessed by Numerical Rating Scale (NRS), evaluate the efficacy of single dose analgesia in combination with local anaesthesia to control pain during TUS guided procedures by Numerical Rating Scale , patient is asked to indicate his/her perceived pain intensity , the patient grades their own pain on a scale between 1 to 10, 30 minutes|Satisfaction assessed by the Visual Analogue Scale (VAS), satisfaction assessment by Visual Analogue Scale , series of faces ranging from a happy face at 0, or no hurt , to a crying face at 10, which represents hurts like the worst pain imaginable , 30 minutes|performance time of transthoracic ultrasound guided procedures, assess the effect of its use with local anaesthesia on procedure performance compared to local anaesthesia alone, up to 20 minutes

Assiut University

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

pain in TUS guided procedures

2021-11

2022-10

2022-10

2021-11-16

2021-11-16

{ "Diclofenac": [ { "intervention_type": "DRUG", "description": "Diclofenac", "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" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT05230433

High-fat Meal Challenge in Pediatrics

https://clinicaltrials.gov/study/NCT05230433

COMPLETED

The objective is to determine if how physical fitness, measured using a treadmill maximal oxidative capacity test, is associated with the capacity to metabolize a high-fat meal in pediatrics (ages 8-17 years). Ability to metabolize the meal will be assessed by profiling mitochondrial and extra-mitochondrial fatty acid metabolites. The investigators will test if fatty acid oxidation mediates the relationship between fitness and markers of metabolic health, such as insulin resistance.

NO

Pediatric Obesity|Insulin Resistance

DIETARY_SUPPLEMENT: High-fat Challenge

Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by daily physical activity., Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Over seven days, participants will be asked to wear an ActiGraph accelerometer (ActiGraph, Pensacola, FL) and complete three dietary recalls. Analysis: Daily time spent in moderate to vigorous physical activity will be calculated (minutes). The average daily time in moderate to vigorous physical activity will be calculated across 7 days (minutes)., Up to 7 days|Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by daily dietary intake., Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Over seven days, participants will be asked to wear an ActiGraph accelerometer (ActiGraph, Pensacola, FL) and complete three dietary recalls. Analysis: Daily dietary intake will be scored using the Healthy Eating Index (scale: 1-12). The average Healthy Eating Index score will be calculated across the 3 days of collected data (scale: 1-12), Up to 7 days|Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by VO2 max., Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Stress testing will use a modified Bruce protocol, increasing in elevation and speed, to measure maximal oxygen consumption (VO2 max). VO2 max describes the milliliters of oxygen consumed in one minute of exercise, per kilogram of body weight (units: mL/min/kg)., Up to 7 days|Determine if the interaction between daily physical activity and dietary intake mediates the correlation between VO2 max and body composition - as measured by body composition., Protocol: Children, aged 8-17 years (body mass index (BMI) percentile ≥ 85% for sex/age, matched with leans [5%≤BMI percentile<85%], n=50), will be recruited. Body composition will be measured using bioelectrical impedance (Seca, Hamburg, Germany). Percent fat mass will be calculated (%) Analysis: Investigators will determine if the interaction between daily physical activity (minutes) and daily dietary intake (score: 1-12) mediates the correlation between VO2 max (mL/min/kg) and body fat percentage (%). Outcome units will describe a linear correlation., Up to 7 days

Assess the correlation between fatty acid oxidation and VO2 max., Protocol: After an overnight fast, participants will consume the high-fat (HF) challenge, composed of palm oil supplemented Boost® (15% kcal carbohydrates, 15% kcal protein, 70% kcal lipid). Blood will be sampled via intravenous line at baseline (0 minutes) and after consuming the challenge (30, 60, 120, and 180 minutes). The investigators will conduct targeted metabolomics on all blood samples, profiling acylcarnitines (AC) and dicarboxylic fatty acid (FA-COOH) metabolites. Analysis: Longitudinal trajectories, measured by empirical Bayes time-series analysis, will quantify the response of metabolites to the challenge. Mixed regression models will determine the correlation between VO2 max (mL/min/kg) and metabolite trajectories. Outcome units will describe a linear correlation., Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day

Assess if fatty acid oxidation mediates the correlation between VO2 max and a continuous metabolic syndrome score., Protocol: The investigators will use fasting blood samples to measure insulin, glucose, lipoproteins, triglycerides, and blood pressure. Analysis: A continuous metabolic score (cMetS) will be calculated composed of insulin, glucose, meal arterial blood pressure, HDL-C, and triglycerides. All of these components will be combined into one measure (score, no units). The investigators will determine if longitudinal trajectories of fatty acid metabolites mediate the correlation between VO2 max (mL/min/kg) and the cMetS score. Outcome units will describe a linear correlation., Five blood draws (fasting, 30 minutes, 60 minutes, 120 minutes, and 180 minutes) all completed on 1 day

Dartmouth-Hitchcock Medical Center

ALL

CHILD

OTHER

INTERVENTIONAL

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

STUDY02001316

2022-05-01

2022-09-19

2023-12-31

2022-02-09

2024-01-23

Dartmouth-Health, Lebanon, New Hampshire, 03766, United States

{ "High-fat Challenge": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT04497233

Prediction Model of Peripheral Pulmonary Lesions Based on R-EBUS Image

https://clinicaltrials.gov/study/NCT04497233

R-EBUS

UNKNOWN

Peripheral pulmonary lesions(PPLs) have a wide spectrum of diseases, and the diagnosis will affect the treatment strategy and prognosis. Radial endobronchial ultrasound (R-EBUS) can be used for non-invasive diagnosis of PPLs, and the supplement pathological diagnosis results of EBUS-TBLB, which has important clinical application value. This project intends to select representative images from R-EBUS dynamic videos for qualitative and quantitative analysis, to establish and verify the diagnostic evaluation system of R-EBUS forPPLs. Then build 1,000 R-EBUS image databases of PPLs, train deep learning networks for automatic extraction and diagnosis of target areas, and automatically extract representative images from videos to establish a benign and malignant prediction model of PPLs. We will provide reliable theoretical basis for the diagnosis of PPLs, and optimize the diagnosis and treatment method.The network would be prospectively verified through 300 R-EBUS images from multi centers.

NO

Diagnoses Disease

Diagnostic efficacy of R-EBUS prediction model., Diagnostic efficacy includes sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy, 18 months

Diagnostic efficacy of traditional qualitative and quantitative methods, Diagnostic efficacy includes sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy, 18 months

Shanghai Chest Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

SHCHE202001

2018-07-01

2020-09-30

2021-03-31

2020-08-04

2020-08-04

Shanghai Chest Hospital, Shanghai, China

{}

NCT05051033

Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)

https://clinicaltrials.gov/study/NCT05051033

PRIMARY

RECRUITING

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

NO

Mitral Valve Regurgitation

PROCEDURE: Mitral valve repair|DEVICE: Transcatheter edge-to-edge repair

All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 3+ MR (by transthoracic echocardiogram (TTE)) composite score., Composite score of all-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 3+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum follow-up of 3 years post randomization (including a one-month post intervention blanking period for HF hospitalizations/urgent visits). Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score s relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean., 3 years post intervention

Adequacy of MR correction, Adequacy of MR correction at one year post intervention, defined as < 2+ MR as assessed by TTE, one year post intervention|Kansas City Cardiomyopathy Questionnaire (KCCQ), Disease-specific quality of life as measured by the KCCQ at 6-month time intervals up to 5 years. KCCQ has 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score. All scores are scaled 0 to 100, with higher scores indicating better health outcome., up to 10 years post intervention|Procedure failure, Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure., End of procedure|Procedure failure, Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure., 10 years post randomization|All-cause mortality, All-cause mortality through 5 years post randomization, 5 years post randomization|All-cause mortality, All-cause mortality from randomization through 10 years post intervention, 10 years post intervention|Cardiovascular and non-cardiovascular mortality, Cardiovascular and non-cardiovascular mortality from randomization through 5 years post intervention, 5 years post intervention|Cardiovascular and non-cardiovascular mortality, Cardiovascular and non-cardiovascular mortality from randomization through 10 years post intervention, 10 years post intervention|Valve re-interventions, Valve re-interventions through 5 years post intervention, 5 years post intervention|Valve re-interventions, Valve re-interventions through 10 years post intervention, 10 years post intervention|Serious or protocol-defined adverse events, Serious or protocol-defined adverse events, including stroke, acute kidney injury (AKI), and renal failure, through 5 years, 5 years post intervention|MR grade, Mitral Regurgitation (MR) grade as mild, moderate, or severe. (grade I-IV, with higher grade indicating poorer health outcomes.), through 5 years post intervention|Left Ventricular Ejection Fraction (LVEF), Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction., through 5 years post intervention|Left Ventricular End Diastolic Dimension (LVEDD), Left ventricular end diastolic dimension (LVEDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter., through 5 years post intervention|Left Ventricular End Systolic Dimension (LVESD), Left ventricular end systolic dimension (LVESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter., through 5 years post intervention|Left Ventricular End Diastolic Volume (LVEDV), Left Ventricular end diastolic volume (LVEDV) is the volume of blood in the left ventricle at the end of the diastole or ventricular filling., through 5 years post intervention|Left Ventricular End Systolic Volume (LVESV), Left Ventricular end systolic volume (LVESV) is the volume of blood in the left ventricle at the end of the systolic ejection phase immediately before the beginning of diastole or ventricular filling., through 5 years post intervention|Mitral valve gradient, The valve gradient is the difference in pressure on each side of the valve. When a valve is narrowed (a condition called stenosis), the pressure on the front of the valve builds up as blood is forced through the narrow opening. This causes a larger pressure difference between the front and back of the valve. The valve gradient can be used to determine the severity of the valve disorder., through 5 years post intervention|Forward stroke volume, The forward stroke volume is the volume entering the aorta., through 5 years post intervention|6 Minute Walk Test (6MWT), Functional status as measured by the 6MWT at yearly time intervals over 5 years. 6MT - The distance covered over a time of 6 minutes, through 5 years post intervention|EuroQol- 5 Dimension (EQ-5D), Generic QoL as measured by the EuroQol-5D (EQ-5D). The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status)., through 10 years post intervention|Length of stay (LOS), Length of stay as measured by number of days hospitalized., through 10 years post intervention|ICU days of index hospitalization, Number of ICU days of index hospitalization, through 10 years post intervention|Number and reasons for readmissions, Number and reasons for readmissions, including for valve re-intervention and readmissions/urgent visits for heart failure, through 10 years post intervention|Cost, Costs associated with the index hospitalization as well as follow-up readmissions will be measured., through 10 years post intervention|Cost-effectiveness, A cost-effectiveness analysis (CEA) comparing cumulative costs and quality-adjusted life years (QALYs) of transcatheter edge-to-edge repair vs surgical repair will be performed from U.S., Canadian, German and United Kingdom health care sector perspectives according to national guidelines., through 10 years post intervention

Annetine Gelijns

National Heart, Lung, and Blood Institute (NHLBI)

ALL

OLDER_ADULT

OTHER

INTERVENTIONAL

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

STUDY-21-01246|5U01HL088942

2022-02-21

2028-01

2032-01

2021-09-21

2024-03-18

Keck Hospital of the University of Southern California, Los Angeles, California, 90033, United States|Cedars Sinai Medical Center, Los Angeles, California, 90048, United States|University of California San Francisco, San Francisco, California, 94143, United States|Stanford University, Stanford, California, 94305, United States|Piedmont Heart Institute, Atlanta, Georgia, 30309, United States|Emory University, Atlanta, Georgia, 30322, United States|Ochsner Clinic, New Orleans, Louisiana, 70121, United States|Maine Medical Center, Portland, Maine, 04102, United States|The Johns Hopkins Hospital, Baltimore, Maryland, 21287, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Brigham and Women s, Boston, Massachusetts, 02115, United States|University of Michigan Hospital, Ann Arbor, Michigan, 48109, United States|Saint Luke s Hospital of Kansas City/MidAmerica Heart and Lung Surgeons, Kansas City, Missouri, 64111, United States|Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States|Nyph/Cumc, New York, New York, 10032, United States|Weill Cornell Medicine/ New York-Presbyterian Hospital, New York, New York, 10065, United States|Northwell Health, New York, New York, 21287, United States|Duke University Hospital, Durham, North Carolina, 27710, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Baylor, Scott and White, Dallas, Texas, 75246, United States|University of Virginia Medical Center, Charlottesville, Virginia, 22903, United States|West Virginia University Hospital, Morgantown, West Virginia, 26506, United States|London Health Sciences, London, Ontario, ON N6A 5W9, Canada|Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University), Quebec City, Quebec, QC G1V 4G5, Canada|Kerckhoff Klinik Bad Nauheim, Bad Nauheim, 61231, Germany|Schüchtermann-Klinik Bad Rothenfelde, Bad Rothenfelde, 49214, Germany|Deutsches Herzzentrum Berlin, Berlin, 13353, Germany|Deutsches Herzzentrum der Charité, Berlin, 13353, Germany|Universitätsklinikum Frankfurt, Frankfurt, 60590, Germany|Universitätsklinikum Freiburg, Freiburg, 79106, Germany|Asklepios Klinik St. Georg Hamburg, Hamburg, 20099, Germany|Universitätsklinikum Hamburg Eppendorf, Hamburg, 20246, Germany|Universitätsklinikum Heidelberg, Heidelberg, 69120, Germany|Universitätsklinikum Jena, Jena, 07747, Germany|Universitätsklinikum Schleswig-Holstein Campus Kiel, Kiel, 24105, Germany|Herzzentrum Leipzig, Leipzig, 04289, Germany|Lübeck, Lübeck, 23538, Germany|Deutsches Herzzentrum München, München, 80636, Germany|South Tees Hospitals NHS Foundation Trust, Middlesbrough, United Kingdom

{ "Mitral valve repair": [ { "intervention_type": "PROCEDURE" } ], "Transcatheter edge-to-edge repair": [ { "intervention_type": "DEVICE" } ] }

NCT04830033

ENO Breathe vs Usual Care in COVID-19 Recovery

https://clinicaltrials.gov/study/NCT04830033

SHIELD ENO

COMPLETED

A randomised clinical trial to assess the impact of an online singing, breathing and wellbeing programme (ENO Breathe) developed specifically for people recovering from COVID-19.

NO

COVID-19 Recovery

OTHER: ENO Breathe group

Change from baseline in RAND-36 (RAND SF-36), A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability., At baseline, then repeated after 6 weeks.

Changes in COPD assessment test (CAT), A respiratory disease health status measure that has been validated in people recovering from COVID-19. This includes 8 items, scored 0-5 with a possible score from 0 (best) to 40 (worst)., At baseline, then repeated after 6 weeks.|Changes in Generalised Anxiety Disorder Assessment (GAD-7), Self-administered questionnaire to assess for symptoms, and severity, of anxiety. Includes seven questions scored from 0 to 3, giving a total score out of 21. Lower scores indicate less symptoms of anxiety., At baseline, then repeated after 6 weeks.|Changes in Patient Health Questionnaire 9 (PHQ-9), Self-administered questionnaire to assess for symptoms, and severity, of depression. Includes nine questions scored from 0 to 3, giving a total score out of 27. Lower scores indicate less symptoms of depression., At baseline, then repeated after 6 weeks.|Changes in Dyspnoea-12 questionnaire, Assessment of dyspnoea. Includes 12 descriptors scored from 0 to 3, giving a total score of 36. Lower scores indicate less severe dyspnoea., At baseline, then repeated after 6 weeks.|Changes in Visual Analogue Scale ratings of breathlessness, Four Visual Analogue Scales, scored from 0 to 100, for participants to rate their breathlessness while i) at rest, ii) walking around the house, iii) climbing stairs, iv) running. Higher scores indicate more severe dyspnoea (breathlessness)., At baseline, then repeated after 6 weeks.|Changes in SF-6D (Short-Form Six-Dimension) scores, The SF-6D uses data from the RAND SF-36 to generate a continuous index for health that can be used to create a quality-of-life score for cost utility analysis., At baseline, then repeated after 6 weeks.

Imperial College London

Imperial College Healthcare NHS Trust

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

SHIELD COVID - ENO sub-study 2

2021-04-28

2021-09-23

2021-09-23

2021-04-02

2021-12-03

National Heart and Lung Institute, Imperial College London, London, SW3 6NP, United Kingdom

{ "ENO Breathe group": [ { "intervention_type": "OTHER" } ] }

NCT02906033

The Effect of A New Perioperative Practice Model on Patient, Nursing And Organisational Outcomes

https://clinicaltrials.gov/study/NCT02906033

COMPLETED

The aim of the study is to improve the surgical patients care process. The objective is to explore the effect of a new perioperative practice model on 1) patient outcomes (satisfaction, surgery-related anxiety and quality of life), 2) nursing outcomes (organizational engagement), and 3) organization outcomes (timeline of surgical care process).

YES

Arthroplasties, Hip Replacement|Arthroplasties, Knee Replacement

OTHER: New perioperative practice model

Change From Baseline to Follow-up in Health Related Quality of Life, The 15D is a generic, comprehensive, 15-dimensional, standardized, self-administered measure of health-related quality of life (HRQoL) that can be used both as a profile and single index score measure. The 15 dimensions are: mobility, vision, hearing, breathing, sleeping, eating, speech, excretion, usual activities, mental functioning, discomfort and symptoms, depression, distress, vitality, and sexual activity The respondent chooses one of the five levels for each dimension that best describes his or her state of health at present moment; the best level is 1 and the worst is 5. The single index score (15D score), representing the overall HRQoL on a 0-1 scale (1=full health, 0=being dead). The results in Outcome Measure Data Table describe the changes from baseline to follow-up within the intervention group and the control group., Baseline and at 3 months follow up

Change in Surgery-related STATE Anxiety From Baseline to Follow-up, The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. This instrument is composed of STATE and TRAIT scales, each of which has twenty items. The STATE items evoke feelings on a 4-point Likert scale, with responses ranging from 1 (not at all) to 4 (very much). The TRAIT items evoke how the respondent feels in general on a frequency scale ranging from 1 (hardly ever) to 4 (almost always). The scores of both STATE and TRAIT scales range from 20 to 80 scores. According to the raw score, anxiety is classified as low (20-39), moderate (40-59) or high (60-80). The results in Outcome Measure Data Table describe the changes from baseline to follow-up within the intervention group and the control group., Baseline and at 3 months follow-up|Quality of Perioperative Care as Experienced by Surgical Patients, Good Perioperative Nursing Care Scale is a constructed questionnaire which contains 36 statements measuring the quality of care, which are summarized into nine quality categories (sum variables/subscales): Pain management (n=5 statements), Temperature maintenance (n=2), Technical skills (n=4), Information (n=6), Encouragement (n= 3), Respect (n= 3), Staff characteristics (n= 5), Environment (n= 6) and Process (n= 2). The quality statements are answered with a five-point Likert scale (fully agree, 5 points - fully disagree, 1 point) with a neutral option neither agree nor disagree and an option cannot evaluate this aspect . The value of each averaged sum variable/subscale varies from 1 to 5. In the analysis, the responses of cannot evaluate this aspect were excluded. The better the mean value is, the more positive experience the participant has of the quality of care., One-point measurement on the day of discharge (on average on the 3rd day after surgery)|Change in Surgery-related TRAIT Anxiety From Baseline to Follow-up, The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes. This instrument is composed of STATE and TRAIT scales, each of which has twenty items. The STATE items evoke feelings on a 4-point Likert scale, with responses ranging from 1 (not at all) to 4 (very much). The TRAIT items evoke how the respondent feels in general on a frequency scale ranging from 1 (hardly ever) to 4 (almost always). The scores from both STATE and TRAIT scales range from 20 to 80 scores. According to the raw score, anxiety is classified as low (20-39), moderate (40-59) or high (60-80). The results in Outcome Measure Data Table describe the changes from baseline to follow-up within the intervention group and the control group., Baseline and at 3 months follow-up

Hospital District of Helsinki and Uusimaa

University of Turku|Karlstad University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

TYH2014211|U1111-1185-9612

2016-09-12

2017-12-21

2017-12-21

2016-09-19

2021-12-06

2021-12-06

Peijas Hospital / Helsinki University Hospital, Vantaa, Finland

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT02906033/Prot_SAP_000.pdf

{ "New perioperative practice model": [ { "intervention_type": "OTHER" } ] }

NCT00543933

Pilot Study of Inhaled Nitric Oxide to Treat Pulmonary Insufficiency in Congenital Heart Disease

https://clinicaltrials.gov/study/NCT00543933

TERMINATED

Inhaled nitric oxide in patients with pulmonic valve insufficiency.

NO

Pulmonary Insufficiency

DRUG: iNO administered

pulmonary regurgitant volume and fraction, Aortic regurgitant fraction measured by CMR velocity flow mapping, Single time point

The Cleveland Clinic

ALL

ADULT, OLDER_ADULT

EARLY_PHASE1

OTHER

INTERVENTIONAL

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

07-491

2007-10

2010-06

2010-06

2007-10-15

2017-01-27

The Cleveland Clinic, Cleveland, Ohio, 44195, United States

{ "iNO administered": [ { "intervention_type": "DRUG" } ] }

NCT05084833

ASPIRES (Activating Cancer Survivors and Their Primary Care Providers to Increase Colorectal Cancer Screening) Study

https://clinicaltrials.gov/study/NCT05084833

ASPIRES

ENROLLING_BY_INVITATION

The primary purpose of this study is to assess the best method for encouraging high-risk cancer survivors to get screened for colorectal cancer at the recommended age.

NO

Colorectal Cancer|Early Detection of Cancer

BEHAVIORAL: Control|BEHAVIORAL: Patient activation|BEHAVIORAL: Primary care provider activation

Proportion of patients who report completing a colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization, This will be measured by self-report on a questionnaire given at 12 months., 12 months

Proportion of patients who complete the colonoscopy or Cologuard test (Cologuard test plus colonoscopy if Cologuard is positive) within 12 months of randomization as measured in medical record reports, The study team will confirm if participants had a colonoscopy or cologuard test by reaching out to the medical site where the participant was screened, and requesting the medical record confirmation., 12 months|Potential barriers and facilitators to the uptake of the intervention at both the patient and provider level as measured by CFIR questions, Consolidated Framework for Implementation Research (CFIR) questions are included in the 12-month questionnaire for participants, the 12-month questionnaire for their primary care providers, and the end of study interviews for the participants, primary care providers, and other medical office staff. CFIR questions are meant to measure 5 domains: intervention characteristics, outer setting, inner setting, characteristics of individuals, and process., 14 months|Other potential barriers and facilitators to the uptake of the intervention at both the patient and provider level, In this study, the potential moderators include patient characteristics, such as age, gender, educational attainment, health insurance coverage, types of insurance, chronic health conditions, and race/ethnicity as well as PCP factors such as knowledge, years in practice, and practice setting. The potential mediators in this study may include the patient s perception of involvement in decision making, health insurance coverage, and whether the patient reviewed the study resources and videos. This will be measured through data collected via the baseline and 12 month questionnaires as well as data previously collected via the St. Jude Childhood Cancer Survivor Study., 12 months|Cost and Cost-Effectiveness Analysis, We will collect data on the replication costs of the intervention and health services from the intervention per participant. The costs of the intervention (e.g. intervention materials, personnel time, and texting costs) will be collected by the University of Chicago team via a cost spreadsheet. The cost of the health services will be collected via the 12-month questionnaire; participants will be asked to share information about the types of medical visits they have had since joining the study., 12 months

University of Chicago

National Cancer Institute (NCI)|St. Jude Children s Research Hospital|Memorial Sloan Kettering Cancer Center|Columbia University|Hunter College of City University of New York|The Hospital for Sick Children|Duke University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

IRB20-1247|R01CA255269-01

2022-02-14

2025-09-01

2025-11-01

2021-10-20

2024-05-08

University of Chicago, Chicago, Illinois, 60637, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10017, United States|Columbia University, New York, New York, 10027, United States|St. Jude Children s Research Hospital, Memphis, Tennessee, 38105, United States

{ "Control": [ { "intervention_type": "BEHAVIORAL" } ], "Patient activation": [ { "intervention_type": "BEHAVIORAL" } ], "Primary care provider activation": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04345133

Effect of Undersized Drilling Upon the Immediate Implants

https://clinicaltrials.gov/study/NCT04345133

COMPLETED

OBJECTIVE: evaluate the effect of undersized drilling upon the primary and secondary stability of immediate implants placed in the anterior sector maxilla. PATIENTS AND METHODS Study design A randomized comparative clinical trial was carried out. Thirty conical MIS C1 grade 23 titanium alloy (Ti 6Al 4V Eli) implants with a rough surface subjected to dual acid etching and sandblasting, measuring 3.75 mm in maximum diameter and 13 mm in length (MIS® Implants Technologies, Ltd. Bar Levi, Israel), were placed immediately after removal a anterior maxillary tooth in a series of patients treated in the clinic of the Master of Dentistry and Dental Implantology (Santa María University, Dental School, Caracas, Venezuela). The study was approved by the local Ethics Committee. Patient selection To enrolled in the study, patients had to comply the inclusion/exclusion criteria established to the study: over 18 years of age with indication of one or more immediate implants in the anterior maxilla; no history of ischemic heart disease, uncontrolled diabetes, coagulation disorders, head or neck radiotherapy, intravenous bisphosphonates or uncontrolled periodontal disease. Based on a CTCB evaluation, the teeth involved should have presence of bone ≥ 5 mm from the tooth apex to the lower cortical layer of the nasal fossa / maxillary sinus and no vertical defects greater than 4 mm at the buccal or palatine alveolar crest. Also, patients must have capacity to understand the study protocol and fill consent form to participation in the study. Study procedure Two operators calibrated for immediate implant placement performed minimally traumatic tooth extraction following local infiltrating anesthesia with 4% articaine and 1:100,000 epinephrine (Artheek® 4%, New Stetic S.A.; Antioquia, Colombia). After evaluating the integrity of the bone walls, drilling sequence was established on a randomized basis. Conventional drilling (CD) sequence: * Marking drill ∅1.9 mm at 1500 rpm * Pilot drill ∅ 2.4 mm and 13 mm in length at 800 rpm. * Twist drill ∅3 mm at 400 rpm. Undersized drilling (UD) sequence: Marking drill ∅1.9 mm at 1500 rpm Pilot drill ∅ 2.4 mm and 13 mm in length at 400 rpm. Implant insertion A surgical motor (MCU MIS, model M0132, W&H, Burmoos, Austria) with a 20:1 reducing implant handpiece was used to insert the implants at 20 rpm and applying a torque of 10 Ncm. Following placement of the implant in the bed, manual insertion was continued to reach the final implant position, established as 4 mm from the gingival margin. Study variables Two torque meters (MIS® Implants LTD, models MT-RI040 and MT-RT070, Bar Levi, Israel) were used to insert and sequentially measure the maximum IT reached on positioning the implant in the socket. A Smart-peg Nro 49 model 100480 was fitted to the connection of each implant and an Osstell ISQ® (SN 4669 Osstell AB, Goteborg, Sweden) was used to perform RFA analysis and obtain corresponding ISQ value at insertion time (RFA1). A 4 mm height healing screw was used to seal the implant, and then additional RFA measurements was made at 6 week (RFA2) and 12 week (RFA3) post-implantation

NO

Implant Stability

DEVICE: Dental Implants Insertion Drilling Sequence

Insertion Torque, Maximum torque in N.cm obtained during insertion of the implant, at baseline, through study completion in average 1 year|RFA Implant Stability, Implant Stability measure by Radio-Frequency Analysis., at baseline, through study completion in average 1 year

RFA2 Implant Stability, Implant Stability measure by Radio-Frequency Analysis 6 weeks later, 6 weeks after baseline, trough study completion in average 1 year|RFA3 Implant Stability, Implant Stability measure by Radio-Frequency Analysis 12 weeks later, 12 weeks after baseline, trough study completion in average 1 year

University of Carabobo

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

UCarabobo

2017-01-09

2017-12-17

2018-03-17

2020-04-14

2020-04-14

{ "Dental Implants Insertion Drilling Sequence": [ { "intervention_type": "DEVICE" } ] }

NCT05080933

ECMO for COVID-19 vs Influenza A H1N1 Associated ARDS

https://clinicaltrials.gov/study/NCT05080933

InfluCOV_ECMO

COMPLETED

Objective: Veno-venous ECMO has been used as a rescue therapy for patients with severe ARDS associated to influenza A H1N1 and COVID19 viral pneumonia. Little is known about outcome of these patients who required extracorporeal support. Research question: To compare outcome of patients who required VV ECMO for Covid19 and H1N1 associated ARDS

NO

ARDS|COVID-19|H1N1 Influenza

All cause mortality on day 60 after ECMO initiation, 60 days

Hospital length of stay, 90 days|ICU length of stay, 90 days|Hospital mortality on day 90 after ECMO initiation, 90 days|ECMO duration, 90 days|ECMO associated hemorrhagic complications, 60 days|ECMO associated mechanical complications, 60 days|Invasive mechanical ventilation duration, 90 days|ECMO related haemorrhagic complications, 90 days|ECMO related mechanical complications, 90 days

University of Turin, Italy

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

v1_12_2020

2009-08-22

2021-02-28

2021-02-28

2021-10-18

2021-10-18

University of Turin - Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, 10126, Italy

{}

NCT05534633

APPROACH 2.0: HIV, HCV and Syphilis Testing Through Pharmacies

https://clinicaltrials.gov/study/NCT05534633

ACTIVE_NOT_RECRUITING

Human Immunodeficiency Virus (HIV), hepatitis C (HCV), and syphilis are sexually transmitted and blood borne infections (STBBI) that affect millions of people worldwide and rates are rising in Canada. HCV and syphilis are curable, and HIV is treatable with virtually no risk of transmission to sexual partners when the infection is controlled, however, these outcomes require adequate testing. Unfortunately, an estimated 44% of Canadians living with HCV and 13% living with HIV are not diagnosed. These undiagnosed cases are the source of over half of new HIV infections. Furthermore, HIV-syphilis coinfection is common. Accessible testing forms a key pillar of an elimination strategy and acts as an access point for linking people to care. Community pharmacies are more accessible site for STBBI testing, compared to hospitals and doctors offices. This is especially true for members of marginalized communities, some of whom are at higher risk of infection. The COVID-19 pandemic highlighted the need for low-barrier STBBI testing, as in-person healthcare services at doctors offices and traditional screening clinics were scaled back. Pharmacies remained open throughout the pandemic. The APPROACH 2.0 study will assess the impact of a pharmacy-based testing program for HIV, hepatitis C, and syphilis in participating pharmacies in three Canadian provinces: Newfoundland & Labrador, Alberta, and Nova Scotia on finding new diagnoses and linkages with care. Participants will be offered point of care tests for HIV and/or HCV and/or a dry blood spot test which will test for HIV, HCV, and syphilis. These tests are easy to administer. Results from the point of care tests are available immediately during the pharmacy visit while participants will be contacted with dried blood spot test results when available (approximately 2 weeks). Participants with reactive tests are linked with confirmatory testing and care, and those with non-reactive results are offered preventative services including HIV PrEP (as indicated) and counselling. This study builds on a pilot study completed in 2017 (www.APPROACHstudy.ca).

NO

HIV Infections|HCV Infection|Syphilis Infection

OTHER: Choice of STBBI test(s)

Number and proportion of new HIV infections found through pharmacy testing in each province, Collected at the end of the study period (approximately one year)|Number and proportion of new HCV infections found through pharmacy testing in each province, Collected at the end of the study period (approximately one year)|Number and proportion of new syphilis infections found through pharmacy testing in each province, Collected at the end of the study period (approximately one year)

Memorial University of Newfoundland

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

HREB-2022.060

2022-12-01

2024-03-31

2024-09-01

2022-09-09

2024-06-26

Memorial University of Newfoundland, St. John s, Newfoundland & Labrador, A1A 0L1, Canada

{ "Choice of STBBI test(s)": [ { "intervention_type": "OTHER" } ] }

NCT05486533

The Effect of Acupressure After Angiography on Pain Level and Hemodynamic Variables

https://clinicaltrials.gov/study/NCT05486533

Acupress

COMPLETED

This randomized controlled study evaluates the effect of acupressure application on the pain level patients after angioography. The hypothesis of this study is that acupressure reduces pain levels and stabilizes hemodynamic variables.

NO

Acupressure|Pain|Hemodynamic Instability|Angiopathy, Peripheral

OTHER: Acupressure

Pain evaluated using the visual analog scale, The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain., Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

Systolic blood pressure, Systolic blood pressure (SBP), mmHg, Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation|Diastolic blood pressure, Diastolic blood pressure (DBP), mmHg, Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation|Heart rate, Beats per minute, Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation|Respiratory rate, Lung breathing, Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation|Peripheral oxygen saturation, %, percentage of oxygenated hemoglobin in peripheral arterial blood, Change from before implementation and immediately after, 10th, 20th and 30th minutes after implementation

Mersin University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

MersinUnive

2022-11-25

2022-12-30

2022-12-30

2022-08-03

2023-01-18

Turkey, Mersin University,, Mersin, Turkey/Mersin,Yenişehir, 33343, Turkey

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

NCT01017133

Fluorine F18-EF5 and Fludeoxyglucose F18 Positron Emission Tomography in Assessing Hypoxia and Glycolysis in Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT01017133

COMPLETED

RATIONALE: Diagnostic procedures, such as positron emission tomography, using the drug fluorine F18-EF5 to find oxygen and fludeoxyglucose F18 to find sugar in tumor cells may help in planning treatment for patients with non-small cell lung cancer.

NO

Non-small Cell Lung Cancer

RADIATION: fludeoxyglucose F 18|RADIATION: Fluorine F 18 EF5|PROCEDURE: Positron emission tomography

P-Akt in tumor cells as assessed by immunohistochemistry|Tumor hypoxia as assessed by 18F-EF5 PET imaging|Tumor Glycolysis as assessed by 18F-FDG PET imaging|Progression-free survival|Overall survival|Toxicity assessed by CTCAE v3.0

Abramson Cancer Center at Penn Medicine

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

UPCC 01509

2009-05

2012-09

2012-09

2009-11-20

2012-09-26

Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States

{ "Fludeoxyglucose": [ { "intervention_type": "RADIATION", "description": "fludeoxyglucose F 18", "name": "Fludeoxyglucose", "synonyms": [ "Fludeoxyglucose", "" ], "drugbank_id": "DB15107", "generic_names": [ "Fludeoxyglucose" ] } ], "Fluorine F 18 EF5": [ { "intervention_type": "RADIATION" } ], "Positron emission tomography": [ { "intervention_type": "PROCEDURE" } ] }

NCT02141633

Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment

https://clinicaltrials.gov/study/NCT02141633

smoker3

COMPLETED

The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2) compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic parameters. With this protocol the Investigators will test the hypotheses that a) there is a correlation between airway and pulmonary vascular endothelial function within the current smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial function in the current smoker group.

YES

Smoking

PROCEDURE: echocardiogram plus albuterol|PROCEDURE: airway blood flow plus albuterol|DRUG: Fluticasone propionate|DRUG: placebo

Airway Blood Flow, compare inhaled albuterol-induced changes in airway blood flow (ΔQaw) in healthy current smokers and lifetime non-smokers as an index of endothelial function in the airway circulation and to compare the results between smokers and non-smokers, before and 15 minutes after albuterol inhalation

Echocardiogram, to compare inhaled albuterol-induced changes in echocardiogram measuring mean pulmonary artery pressure (MPAP)in healthy current smokers and lifetime non-smokers as an index of endothelial function in the pulmonary circulation and to compare the results between smokers and non-smokers, MPAP before and 15 minutes after albuterol inhalation in smokers vs non-smokers

University of Miami

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

20120896

2013-04

2015-06

2015-12

2014-05-19

2016-12-16

2016-12-16

University of Miami School of Medicine, Miami, Florida, 33136, United States

{ "Albuterol": [ { "intervention_type": "PROCEDURE", "description": "echocardiogram plus albuterol", "name": "Albuterol", "synonyms": [ "Albuterol Sulfate", "Albuterol", "Salbutamolum", "2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol", "Proair", "Accuneb", "Salbutamol", "Ventolin", "Sultanol", "salbutamol", "ProAir", "Volmax", "Proventil", "Salamol", "Salbutamol inhaler", "Ventolin", "Asmalal", "Pulvinal", "Airomir", "Easi-Breathe", "Easyhaler", "Salbulin", "Salamol", "Salbutamol inhaler", "Ventolin", "Asmalal", "Pulvinal", "Airomir", "Easi-Breathe", "Easyhaler", "Salbulin", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum" ], "medline_plus_id": "a682145", "generic_names": [ "Albuterol", "Salbutamol", "Procaterol", "Procaterol" ], "mesh_id": "D058666", "drugbank_id": "DB01001", "wikipedia_url": "https://en.wikipedia.org/wiki/Salbutamol", "nhs_url": "https://www.nhs.uk/medicines/salbutamol-inhaler" }, { "intervention_type": "PROCEDURE", "description": "airway blood flow plus albuterol", "name": "Albuterol", "synonyms": [ "Albuterol Sulfate", "Albuterol", "Salbutamolum", "2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol", "Proair", "Accuneb", "Salbutamol", "Ventolin", "Sultanol", "salbutamol", "ProAir", "Volmax", "Proventil", "Salamol", "Salbutamol inhaler", "Ventolin", "Asmalal", "Pulvinal", "Airomir", "Easi-Breathe", "Easyhaler", "Salbulin", "Salamol", "Salbutamol inhaler", "Ventolin", "Asmalal", "Pulvinal", "Airomir", "Easi-Breathe", "Easyhaler", "Salbulin", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum" ], "medline_plus_id": "a682145", "generic_names": [ "Albuterol", "Salbutamol", "Procaterol", "Procaterol" ], "mesh_id": "D058666", "drugbank_id": "DB01001", "wikipedia_url": "https://en.wikipedia.org/wiki/Salbutamol", "nhs_url": "https://www.nhs.uk/medicines/salbutamol-inhaler" } ], "Fluticasone": [ { "intervention_type": "DRUG", "description": "Fluticasone propionate", "name": "Fluticasone", "synonyms": [ "Fluticason", "Flovent", "Fluticasone", "Flovent HFA", "Flixotide", "Propionate, Fluticasone", "Flixonase", "Fluticasonum", "HFA, Flovent", "Armonair", "Cutivate", "Flonase", "Fluticasona", "Fluticasone Propionate", "Fluticasone propionate", "Flovent", "Flonase", "Flixotide", "Fluticasone propionate", "Flovent", "Flonase", "Flixotide", "Fluticasone propionate", "Flovent", "Flonase", "Flixotide", "Fluticasone propionate", "Flovent", "Flonase", "Flixotide", "Fluticasone propionate", "Flovent", "Flonase", "Flixotide", "Fluticasone inhalers", "Flixotide", "Fluticasone propionate", "Flovent", "Flonase", "Flixotide", "Fluticasone inhalers", "Flixotide", "Flixonase", "Fluticasone nasal spray and drops", "Avamys", "Nasofan", "Flixonase", "Fluticasone nasal spray and drops", "Avamys", "Nasofan", "Fluticasone propionate", "Flovent", "Flonase", "Flixotide" ], "medline_plus_id": "a601057", "generic_names": [ "Fluticasone", "Fluticasone propionate", "Fluticasone propionate", "Fluticasone propionate", "Fluticasone propionate", "Fluticasone propionate", "Fluticasone propionate", "Fluticasone propionate" ], "nhs_url": "https://www.nhs.uk/medicines/fluticasone-skin-creams", "mesh_id": "D018926", "drugbank_id": "DB13867" } ], "placebo": [ { "intervention_type": "DRUG" } ] }

NCT05000333

Consequences of Covid-19 on the Psychological and Physical Health of the Nursing Staff and on Their Professional Activity.

https://clinicaltrials.gov/study/NCT05000333

COMPLETED

The aim of this research is to identify the consequences of the Covid-19 on the physical and psychological health of the nursing staff of the Intercommunal Hospital of Villeneuve-Saint-Georges and on their professional activity thanks to a self-questionnaire. This anonymous self-questionnaire is intended for all the CHIV care workers who were infected by the coronavirus during the first wave and identified by the occupational health service.

NO

Work-related Illness

OTHER: Self-questionnaire

Physical and psychological health, Percentage of physical and psychological after-effects, up to 1 month

Recognized occupational diseases, Number of recognized occupational diseases, up to 1 month|Days of sick leave, Evaluate the number of days of sick leave., up to 1 month|Reclassifications, Evaluate the number of reclassifications, up to 1 month|workstation adjustments, Evaluate the number workstation adjustments, up to 1 month|Repercussions on the professional activity, The existence of repercussions on the professional activity, up to 1 month

Centre Hospitalier Intercommunal Creteil

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

SST-Covid Impact

2021-09-03

2022-03-15

2022-04-28

2021-08-11

2022-08-18

Centre Hospitalier Intercommunal de Villeneuve-Saint-Georges, Villeneuve-Saint-Georges, IDF, 94190, France

{ "Self-questionnaire": [ { "intervention_type": "OTHER" } ] }

NCT05104333

Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes

https://clinicaltrials.gov/study/NCT05104333

UNKNOWN

To evaluate the post-marketing immunogenicity, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.

NO

COVID-19 Pneumonia

BIOLOGICAL: Covid-19 vaccine (0-1-4 schedule)|BIOLOGICAL: Covid-19 vaccine (0-1-6 schedule)

Seroconversion rate, the rate of positive seroconversion against coronavirus, Up to 28 days after the booster dose|Neutralizing antibody level, neutralizing antibody level against coronavirus, Up to 28 days after the booster dose|Neutralizing antibody level, neutralizing antibody level against coronavirus, Up to 84 days after the booster dose|Neutralizing antibody level, neutralizing antibody level against coronavirus, Up to 168 days after the booster dose|Neutralizing antibody level, neutralizing antibody level against coronavirus, Up to 252 days after the booster dose|Neutralizing antibody level, neutralizing antibody level against coronavirus, Up to 336 days after the booster dose

Adverse events following vaccination, analyse the incidence of adverse events following immunization, both solicited and unsolicited, Up to 6 months after the booster dose

China National Biotec Group Company Limited

Guizhou Center for Disease Control and Prevention|Hunan Provincial Center for Disease Control and Prevention|Center for Disease Control and Prevention, Fujian|Beijing Institute of Biological Products Co Ltd.

ALL

ADULT, OLDER_ADULT

PHASE4

INDUSTRY

INTERVENTIONAL

Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION

COVAX BOOSTER (HT/DM)-Beijing

2021-11

2022-11

2022-12

2021-11-03

2021-11-03

Nan an Center for Disease Control and Prevention, Quanzhou, Fujian, China|Yong an Center for Disease Control and Prevention, Sanming, Fujian, China|Youxi Center for Disease Control and Prevention, Sanming, Fujian, China|Songtao Miao Autonomous County Center for Disease Control and Prevention, Tongren, Guizhou, China|Linli County Center for Disease Control and Prevention, Changde, Hunan, China

{ "Covid-19 vaccine (0-1-4 schedule)": [ { "intervention_type": "BIOLOGICAL" } ], "Covid-19 vaccine (0-1-6 schedule)": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00532233

SD, IL-13 Production Rate in IPF

https://clinicaltrials.gov/study/NCT00532233

COMPLETED

The purpose of this study is to investigate how QAX576 affects levels of interleukin 13 (IL-13) in patients with idiopathic pulmonary fibrosis (IPF).

NO

Idiopathic Pulmonary Fibrosis

DRUG: QAX576

-To investigate the possibility that some IPF patients experience increased IL-13 production. Blood samples to be collected pre-dose and weekly after dosing. -To investigate the hypothesis that QAX576 will neutralize IL-13 in patients with IPF, Week 1,2,3 and 4

-To evaluate the changes in biomarkers in blood over time in patients with IPF. Serum samples will be obtained at pre-dose and 2 weeks post-dose., Week 3

Novartis Pharmaceuticals

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

CQAX576A2202

2007-09

2009-06

2009-06

2007-09-20

2020-12-19

Novartis Investigative Site, Denver, Colorado, 80206, United States|Novartis Investigative Site, Atlanta, Georgia, 30319, United States|Novartis Investigative Site, New Orleans, Louisiana, 70112, United States|Novartis Investigative Site, Rochester, Minnesota, 55905, United States|Novartis Investigative Site, Durham, North Carolina, 27704, United States|Novartis Investigative Site, Pittsburgh, Pennsylvania, 15213, United States

{ "QAX576": [ { "intervention_type": "DRUG" } ] }

NCT04627233

Ezrin Peptide (HEP-1) for Treatment of Coronavirus Disease (COVID-19) Infection

https://clinicaltrials.gov/study/NCT04627233

UNKNOWN

Currently, SARS-CoV-2 the novel member of the corona virus family, affecting the world leading to COVID-19 disease. It can result life-threatening condition by developing severe acute respiratory distress syndrome (ARDS). Based on previous evidence a group of patients with severe COVID-19 develop a cytokine storm syndrome which leads to hyper-inflammation lung tissue damage. Supportive care is the current management of COVID-19 is and management of ARDS as a main cause of mortality has been remained challenging. Therefore, an urgent effective treatment of COVID-19 regarding hyper-inflammation mechanism is required. Currently, development of novel anti-viral agents and vaccines are the main issues. However, it needs long time, from months to years, until suitable new medications and vaccines have been developed. An immune-modulatory tetra deca peptide (14-mer peptide) named Human Ezrin Peptide 1 (HEP-1) (trade name Gepon) was introduced by the group of Ataullakhanov in Russia. Regarding its proved anti-viral and anti-inflammatory effect, Russian authorities approved Gepon for treatment of ulcerative colitis treatment and Hepatitis -C. In this regard, it seems that Hep-1 is a very safe immune-modulatory agent which can be effective in the management of COVID-19 infection without any adverse effect for the patient.

NO

Covid19|Treatment|Corona Virus Infection

DRUG: Human Ezrin Peptide 1 (HEP1)|DRUG: Placebo

Time to clinical improvement of disease symptoms, 7 days|Duration of Hospitalization, 28 days|Duration of artificial ventilation, 28 days

CT Severity score, Range 0-40, 28 days|CBC, 28 days|IL-1, 28 days|IL-6, 28 days|TNF, 28 days|CRP, 28 days

Shahid Beheshti University of Medical Sciences

praxisgemeinschaft für zelltherapie

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

IR.SBMU.REC.1399.023

2020-12-20

2021-03-01

2021-04-01

2020-11-13

2020-11-13

Shahid Beheshti University of Medical Sciences, Tehran, Iran, Islamic Republic of

{ "Human Ezrin Peptide 1 (HEP1)": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT05845333

Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women

https://clinicaltrials.gov/study/NCT05845333

RECRUITING

Substance use disorders and psychopathy are serious and costly mental health issues. Psychopathy is known to be associated with aberrant moral decision making and there is considerable interest in determining whether substance use disorders lead to impairments in these same cognitive processes. Recent large-scale research initiatives in forensic settings have begun to identify substance abuse and psychopathy-related disruption in the neural mechanisms involved in moral decision-making processes, and associations between these neural networks and future relapse and antisocial behavior. Here the investigators extend prior work (with incarcerated men) to examine these issues among incarcerated women in order to better understand sex differences. This project addresses the overall lack of neurocognitive research in criminal offenders with substance use disorders, thereby focusing on a major public health issue in an underserved and understudied population.

NO

Stimulant Abuse|Criminal Behavior

OTHER: Decision task

Gray matter volume during MRI scan & stimulant use, Gray matter volume (using relevant MRI analysis platforms - Statistical Parametric Mapping/SPM) correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|White matter integrity during MRI scan & stimulant use, White matter integrity (using relevant MRI analysis platforms - Functional Magnetic Resonance Imaging of the Brain software library (FSL)) correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional brain response during MRI scan & stimulant use during simple linguistic decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional brain response during MRI scan & stimulant use during simple picture decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Picture Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional brain response during MRI scan & stimulant use during moral linguistic decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional brain response during MRI scan & stimulant use during moral picture decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Picture Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional connectivity during MRI scan & stimulant use during simple linguistic decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT) during Simple Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional connectivity during MRI scan & stimulant use during simple picture decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT) during Simple Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional connectivity during MRI scan & stimulant use during moral linguistic decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Linguistic Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Functional connectivity during MRI scan & stimulant use during moral picture decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Picture Decision Task correlation with stimulant use (assessed using a modified version of the Addiction Severity Index), During MRI procedure|Gray matter volume during MRI scan & psychopathic traits, Gray matter volume (using relevant MRI analysis platforms - Statistical Parametric Mapping/SPM) correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|White matter integrity during MRI scan & psychopathic traits, White matter integrity (using relevant MRI analysis platforms - Functional Magnetic Resonance Imaging of the Brain software library (FSL)) correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional brain response during MRI scan & psychopathic traits during simple linguistic decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional brain response during MRI scan & psychopathic traits during simple picture decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Simple Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional brain response during MRI scan & psychopathic traits during moral linguistic decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional brain response during MRI scan & psychopathic traits during moral picture decision task, Functional brain responses (Blood Oxygen Level Dependent/BOLD) (using relevant MRI analysis platforms - SPM, Group Independent Components Analysis Functional Toolbox/GIFT) during Moral Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional connectivity during MRI scan & psychopathic traits during simple linguistic decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT) during Simple Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional connectivity during MRI scan & psychopathic traits during simple picture decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT)) during Simple Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional connectivity during MRI scan & psychopathic traits during moral linguistic decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Linguistic Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Functional connectivity during MRI scan & psychopathic traits during moral picture decision task, Functional connectivity (using relevant analysis MRI platforms - GIFT) during Moral Picture Decision Task correlation with psychopathic traits (assessed using the Psychopathy Checklist-Revised), During MRI procedure|Relapse to/change in stimulant use post-release, Return to stimulant use (assessed using timeline follow back calendar (TLFB)) post-release from incarceration, Every 3 months post release for duration of grant (5 years)|Return to/change in antisocial behavior post-release, Return to antisocial behavior (assessed via self report and/or official records) post-release from incarceration, Every 3 months post release for duration of grant (5 years)

The Mind Research Network

FEMALE

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

15050

2022-08-01

2027-05-31

2027-05-31

2023-05-06

2024-03-15

The Mind Research Network, Albuquerque, New Mexico, 87106, United States

{ "Decision task": [ { "intervention_type": "OTHER" } ] }

NCT06403033

Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion

https://clinicaltrials.gov/study/NCT06403033

COMPLETED

Correcting the skeletal class II using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. However, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. Therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block.

NO

Orthodontic Appliance Complication|Malocclusion, Angle Class II, Division 1

DEVICE: Mini-implant-supported Twin-Block|DEVICE: Twin-Block

Change in the overjet, Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the labial surface of the lower central incisor (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the overbite, Lateral cephalometric images were taken for each patient. This was measured vertically from the upper to the lower central incisors edges (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the molar relationship, Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to the mesial cusp of the mandibular first permanent molar (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the position of the maxillary base, Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to a vertical reference plane (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the position of the mandibular base, Lateral cephalometric images were taken for each patient. This was measured sagittally from Pogonion Point to a vertical reference plane (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the mandibular position relative to the upper jaw, Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to Pogonion Point (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in condylar head position, Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion point to the vertical reference plane (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the composite mandibular length, Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion Point to the Pogonion Point (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in position of the maxillary incisor, Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the A Point (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in position of the mandibular incisor, Lateral cephalometric images were taken for each patient. This was measured sagittally from the lower central incisor edge to the Pogonion Point (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in position of the maxillary permanent first molar, Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to A Point (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in position of the mandibular permanent first molar, Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the mandibular first permanent molar to the Pogonion Point (in mm)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the ramus height, Lateral cephalometric images were taken for each patient. The distance was measured vertically from the Articular Point (Ar) to the Gonion Point (Go) in millimeters., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the corpus length, Lateral cephalometric images were taken for each patient. This was measured sagittally from the Gonion (Go) Point to the Mention (Me) Point. The distance is measured in mm., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in MM angle, Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. It is calculated for the internal angle formed by the intersection between the maxillary and mandibular planes., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the SN-OP, Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the occlusal plane (OP) and the anterior cranial base (the distance between Sella (S) and Nasion (N)) in the vertical direction., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the SN-MP, Lateral cephalometric images were taken for each patient This angle, measured in degrees, represented the relationship between the lower jaw plane and the cranial base in the vertical direction., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me), Lateral cephalometric images were taken for each patient. This angle, measured in degrees, was the sum of three angles: the saddle angle (N-S-Ar angle), the articular angle (S-Ar-Go), and the gonial angle (Ar-Go-Me)., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the inclination of the upper incisors., Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the upper incisor axis and the anterior cranial base in the anteroposterior direction. It was measured between the upper incisor axis and the SN plane., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.|Change in the L1-MP angle, Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the lower incisor axis and the mandibular base in the anteroposterior direction. It was measured between the lower incisor axis and the Go-Me plane., T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

Damascus University

ALL

CHILD

OTHER

INTERVENTIONAL

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

UDDS-Ortho-3-2024

2022-09-10

2023-11-27

2023-12-26

2024-05-07

2024-05-09

Department of Orthodontics, Faculty of Dentistry, University of Damsacus, Damascus, DM20 HAJ72, Syrian Arab Republic

{ "Mini-implant-supported Twin-Block": [ { "intervention_type": "DEVICE" } ], "Twin-Block": [ { "intervention_type": "DEVICE" } ] }

NCT00896233

Magnetic Resonance Elastography for Assessment of Liver Fibrosis (MK-0000-132)(COMPLETED)

https://clinicaltrials.gov/study/NCT00896233

COMPLETED

This study will assess the repeatability of Magnetic Resonance Elastography (MRE) in both healthy volunteers and Hepatitis C Virus (HCV)-infected patients with fibrosis and lay the groundwork for the validation of MRE as an alternative to liver biopsy.

YES

Liver Fibrosis|Hepatitis C Virus

PROCEDURE: MRE

Repeated Maximum Liver Elastic Stiffness (Kilopascal [kPa]) Measurements, Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI s selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI s) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation., 14 days|Repeated Mean Liver Elastic Stiffness (kPa) Measurements, Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single ROI that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI s selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI s) analysis methods were compared. The mean was the overall mean of the data and the standard deviation was the within participant standard deviation., 14 days|Percent Difference in Mean Liver Stiffness Between Hepatitis C Virus (HCV)- Positive Participants With Liver Fibrosis and Healthy Participants, Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI s selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI s) analysis methods were compared., 14 days|Percent Difference in Maximum Liver Stiffness Between HCV- Positive Participants With Liver Fibrosis and Healthy Participants, Reader evaluated 4 sections of the liver at 4 different time points and the end result was a single region of interest (ROI) that could be measured in the registered elastograms at each of the time points. Stiffness measures obtained using the Individual ROI (average of the 4 individual ROI s selected by the reader, one for each slice of liver) and Common ROI (intersection (or area of common overlap) of the 4 individual ROI s) analysis methods were compared., 14 days

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

0000-132|2009_588

2009-08

2010-01

2010-01

2009-05-11

2011-09-22

2015-08-25

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

NCT04454333

COVID-19 in Pain Perspective

https://clinicaltrials.gov/study/NCT04454333

COMPLETED

In our hospital s Infectious Diseases and Clinical Microbiology service, patients who have been hospitalized due to Covid -19 infection have a musculoskeletal pain and headache during this process, and 466 patients will be recruited to compare them with the pre-disease state of the patients and to evaluate the pain status of the patients after treatment.

NO

Infection|COVID|Pain

Numeric Rating Scale for Pain, Evaluation of severity of pain for head, back-neck and extremities by Numeric Rating Scale. Scoring will be done between 0 minimum and 10 maximum values. Higher scores mean worse outcome., up to 10 weeks|Hospital Anxiety and Depression Scale (HADS), Evaluation of patient s anxiety and depression level in hospital by Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report screening scale. It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21. Higher scores mean a worse outcome., up to 10 weeks|SF-12 Health assesment Questionaire, Evaluation of patient s quality of life by SF-12 Health assesment Questionaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Higher scores mean a better outcome., up to 10 weeks

Sisli Hamidiye Etfal Training and Research Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2811

2020-06-03

2020-06-18

2020-06-20

2020-07-01

2020-07-01

Şişli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey

{}

NCT03934333

A Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 Compared With Pulmicort Flexhaler (ELBRUS)

https://clinicaltrials.gov/study/NCT03934333

COMPLETED

This study is to compare the systemic exposure of budesonide delivered by the combination inhaler (budesonide/albuterol sulfate pressurized inhalation suspension [BDA metered dose inhaler {BDA MDI}]) with Pulmicort Flexhaler dry-powder inhaler (DPI).

NO

Relative Bioavailability

DRUG: BDA MDI 160/180 mcg|DRUG: Pulmicort Flexhaler 180 mcg

Area under plasma concentration-time curve from time zero to infinity (AUC) for budesonide, To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Area under the plasma concentration-curve from time zero to time of last quantifiable concentration [AUC(0-t)] for budesonide, To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Maximum observed plasma concentration (Cmax) for budesonide, To compare the systemic exposure of budesonide after single-dose administration of BDA MDI versus Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)

Time to reach maximum observed plasma concentration (tmax), To determine tmax for budesonide delivered by BDA MDI and Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Time of last quantifiable plasma concentration (tlast), To determine tlast for budesonide delivered by BDA MDI and Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t½λz), To determine t½λz for budesonide delivered by BDA MDI and Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Terminal elimination rate constant (λz), To determine λz for budesonide delivered by BDA MDI and Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Apparent total body clearance of drug from plasma after extravascular administration (CL/F), To determine CL/F for budesonide delivered by BDA MDI and Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F), To determine Vz/F for budesonide delivered by BDA MDI and Pulmicort Flexhaler, On Day 1 (Pre-dose and 5, 15, 20, 30 and 45 minutes and 1, 2, 3, 4, 6, 8, 10 and 12 hours post dose) and on Day 2 (24 hours post-dose)|Number of participants with adverse events and serious adverse events, To assess the safety and tolerability of BDA MDI and Pulmicort Flexhaler, From screening (Day -27 to Day -2) to post study visit ( 5-7 days)

AstraZeneca

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

D6930C00011

2019-05-16

2019-09-10

2019-09-10

2019-05-01

2019-10-01

Research Site, Baltimore, Maryland, 21225, United States

{ "BDA MDI 160/180 mcg": [ { "intervention_type": "DRUG" } ], "Budesonide": [ { "intervention_type": "DRUG", "description": "Pulmicort Flexhaler 180 mcg", "name": "Budesonide", "synonyms": [ "Entocort", "Entocort CR", "Jorveza", "Cortiment", "Tarpeyo", "Budesonide, (S)-Isomer", "Pulmicort", "capsules and granules", "Budesonide, (R)-Isomer", "Horacort", "Budes\u00f3nida", "Rhinocort", "(11\u03b2,16\u03b1)-16,17-(Butylidenebis(oxy))-11,21-dihydroxypregna-1,4-diene-3,20-dione", "Benacort", "Budenofalk", "Budesonide", "Budelin", "Budesonide inhalers", "Pulmicort", "Budelin", "Budesonide inhalers", "Pulmicort" ], "medline_plus_id": "a699056", "generic_names": [ "Budesonide" ], "nhs_url": "https://www.nhs.uk/medicines/budesonide-tablets-capsules-and-granules", "mesh_id": "D005938", "drugbank_id": "DB01222" } ] }

NCT06013033

DDX17 Orchestrate Septic Vascular Endothelial Pyroptosis by Controlling Gasdermin D Pore Formation

https://clinicaltrials.gov/study/NCT06013033

NOT_YET_RECRUITING

Objective: To investigate the correlation between plasma levels of DDX17 and GSDMD with vascular endothelial dysfunction and prognosis of in sepsis patients. Design: A single center, prospective, observational research. Participants: Patients with sepsis who are hospitalized to Southeast University Affiliated Zhongda Hospital and meet the diagnostic criteria for sepsis 3.0. Inclusion criteria:1. There is a potential or clear infection; 2. Sequential organ failure score (SOFA score) increases by more than or equal to 2 points compared to the baseline value; 3. Sign informed consent form. Exclusion criteria: Age<18 years old or>80 years old, pregnant women, tumor patients, including diseases that may be complicated with vascular endothelial damage: hypertension, acute and chronic hepatitis (hepatitis caused by virus), liver cirrhosis, PT prolongation after liver transplantation, acute myocardial infarction, chronic tubular nephritis, chronic renal insufficiency/maintenance hemodialysis, renal transplantation, interstitial pneumonia, acute pancreatitis, active phase of systemic lupus erythematosus Ulcerative colitis, Crohn s disease, HELLP syndrome. Primary outcome: 28-day mortality. Secondary outcome: Plasma levels of DDX17 and GSDMD, and their correlation with vascular endothelial injury, severity, and prognosis in sepsis patients.

NO

Sepsis|Septic Shock

28-day mortality, 28 days

correlation between plasma level of DDX17 and vascular endothelial injury, severity, and prognosis in sepsis patients, 28 days|correlation between plasma level of GSDMD and vascular endothelial injury, severity, and prognosis in sepsis patients, 28 days

Zhongda Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

82202393

2023-09-01

2025-12-31

2025-12-31

2023-08-28

2023-09-06

{}

NCT02899533

[18F]FES PET/CT in PAH

https://clinicaltrials.gov/study/NCT02899533

TERMINATED

In this study positron emission tomography (PET/CT) imaging will be used to evaluate evaluation of estrogen receptor heterogeneity and functionality in Pulmonary Arterial Hypertension (PAH) using the investigational radiotracer [18F]fluoroestradiol (FES).

NO

Pulmonary Arterial Hypertension

DRUG: [18F] FES

Evaluate [18F]FES uptake in patients with Pulmonary Arterial Hypertension (PAH) before and after initiation of fulvestrant., Patients will have a baseline FES PET/CT scan prior to the initiation of fulvestrant and a second FES PET/CT scan 9 weeks after the initiation of fulvestrant., Change from Baseline [18F]FES uptake at 9 weeks.

FES uptake and change with treatment, Evaluate baseline [18F]FES PET/CT uptake and change in uptake with fulvestrant in patients with PAH as a predictor of treatment response., baseline|Change in FES compared to change in hematopoietic progenitor cells, Correlate change in [18F]FES uptake with changes in the number of circulating hematopoietic progenitor cells after the administration of fulvestrant in PAH., 2 years|Change in FES compared to change in hormone levels, Correlate change in [18F]FES uptake with changes in plasma hormone levels (pg/mL) after the administration of fulvestrant in PAH., 2 years|Change in FES compared to change in NT-proBNP, Correlate change in [18F]FES uptake with changes in NT-proBNP (pg/mL) after the administration of fulvestrant in PAH., 2 years|Change in FES compared to change in plasma biomarkers, Correlate change in [18F]FES uptake with changes in other plasma biomarkers (pg/mL) after the administration of fulvestrant in PAH., 2 years

University of Pennsylvania

FEMALE

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

824918

2016-07

2021-04-06

2021-04-06

2016-09-14

2021-05-18

University of Pennsylvania Hospital, Philadelphia, Pennsylvania, 19104, United States

{ "[18F] FES": [ { "intervention_type": "DRUG" } ] }

NCT00913133

Safety Study of Desirudin, an Anticoagulant for the Prophylaxis of Thrombosis

https://clinicaltrials.gov/study/NCT00913133

DESIR-ABLE

COMPLETED

The objective of this trial is to demonstrate the clinical utility of fixed-dose SC Desirudin for the prophylaxis of thrombosis as an alternative to heparin-based anticoagulation.

YES

Thrombosis

DRUG: Desirudin

Major Bleeding, Major bleeding is defined as clinically evident hemorrhage associated with a hemoglobin decrease ≥2 g/dL that leads to a transfusion of ≥2 units of whole blood or packed red cells outside of the peri-operative period (time from the start of the surgery or procedure and up to 12 hours after), or hemorrhage that is intracranial, retroperitoneal, or into a prosthetic joint., 24 hours after last dose of study drug

Thrombosis, * New onset symptomatic thrombosis requiring medical or surgical intervention; * Death due to thrombosis defined as fatal pulmonary embolism, ischemic stroke, mesenteric thrombosis or myocardial infarction., Up until 24 hours after last dose of study drug

Canyon Pharmaceuticals, Inc.

ALL

ADULT, OLDER_ADULT

PHASE4

INDUSTRY

INTERVENTIONAL

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

DES-09-02

2010-03

2011-06

2011-06

2009-06-04

2013-01-03

2013-01-10

University of Colorado Health Science Center, Aurora, Colorado, 80045, United States|University of South Florida, Tampa General Hospital, Tampa, Florida, 33606, United States|Saint Joseph s Research Institute, Atlanta, Georgia, 30342, United States|Southeastern Center for Clinical Trials, Decatur, Georgia, 30033, United States|Provena St. Joseph s Medical Center, Joliet, Illinois, 60435, United States|Illinois Lung and Critical Care Institute, Peoria, Illinois, 61606, United States|St. John s Mercy Medical Center, St. Louis, Missouri, 63141, United States|Overlook Hospital, Summit, New Jersey, 07901, United States|Weill Cornell Medical College, New York, New York, 10065, United States|Stony Brook University Medical Center, Stony Brook, New York, 11794-8191, United States|Forsyth Regional Medical Center, Winston-Salem, North Carolina, 27103, United States|Forsyth Regional Medical Center, Winston-Salem, North Carolina, 55902, United States|The Ohio State University Medical Center, Columbus, Ohio, 43210, United States|Drexel University College of Medicine, Philadelphia, Pennsylvania, 19102-1192, United States|Research Concepts, Memorial Hermann Healthcare System, Houston, Texas, 77024, United States|Carilion Roanoke Memorial Hospital, Roanoke, Virginia, 24014, United States

{ "Desirudin": [ { "intervention_type": "DRUG", "description": "Desirudin", "name": "Desirudin", "synonyms": [ "63-Desulfohirudin (recombinant)", "Hirudin desirudin", "63-Desulfohirudin", "63-Desulfohirudin (Hirudo Medicinalis Isoform HV1)", "Desirudin", "Desirudina", "Desirudin recombinant" ], "drugbank_id": "DB11095", "generic_names": [ "Desirudin" ] } ] }

NCT04681833

Safety and Efficacy of BARS13 in the Elderly

https://clinicaltrials.gov/study/NCT04681833

ACTIVE_NOT_RECRUITING

Advaccine Clinical Research are developing a vaccine called BARS13 for the active immunisation of infants (aged 6 months to 5 years old) and the elderly (aged 60-80 years old) for the seasonal prevention of Respiratory Syncytial Virus (RSV) infection. A total of 125 volunteers aged 60 - 80 years (inclusive) will be enrolled in this study, and will be divided into 3 groups (or cohorts ) of 40 people (cohort 1 and 2) and 45 people (cohort 3). The aim of the study is to evaluate the safety and tolerability of BARS13 in this age group.

NO

Respiratory Syncytial Virus Infections

DRUG: Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo|DRUG: Recombinant Respiratory Syncytial Virus Vaccine (BARS13)|DRUG: Placebo

Incidence and severity of vaccine-related AEs, including the following solicited AEs, Incidence and severity of local reactions (pain, tenderness, erythema, swelling, other e.g., ulceration, scabs, bruising, itching and paraesthesia) at the site of vaccination; Incidence and severity of systemic reactions (fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea, diarrhea, light-headedness, dizziness, hypersensitivity and headache). Any solicited AE with onset outside the specified 7-day period of follow-up will be reported as an unsolicited AE., From baseline (Day 1) to the end of Day 7.|Incidence and severity of vaccine-related AEs, including the following solicited AEs, Incidence and severity of local reactions (pain, tenderness, erythema, swelling, other e.g., ulceration, scabs, bruising, itching and paraesthesia) at the site of vaccination; Incidence and severity of systemic reactions (fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea, diarrhea, light-headedness, dizziness, hypersensitivity and headache). Any solicited AE with onset outside the specified 7-day period of follow-up will be reported as an unsolicited AE., From Day 28 to the end of Day 35.|Incidence and severity of vaccine-related AEs, including the following solicited AEs, Incidence and severity of local reactions (pain, tenderness, erythema, swelling, other e.g., ulceration, scabs, bruising, itching and paraesthesia) at the site of vaccination; Incidence and severity of systemic reactions (fatigue, myalgia, malaise, fever, rigors, arthralgia, nausea, diarrhea, light-headedness, dizziness, hypersensitivity and headache). Any solicited AE with onset outside the specified 7-day period of follow-up will be reported as an unsolicited AE., From Day 57 to the end of Day 64 (only for multiple high repeat dose group).|Occurrence of AEs, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment., From baseline (Day 1) to the end of the 7-day, 28-day follow up period after each vaccination|Occurrence of any AE during a 60-minute post-vaccination safety observation period, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment., On Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)|Occurrence of any AE leading to withdrawal, An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment., During the 28-day follow up period after each vaccination|Occurrence of any serious adverse event (SAE), A SAE is any untoward medical occurrence that, at any dose: • Results in death; • Is life-threatening, (NOTE: The term life-threatening in the definition of serious refers to an event/reaction in which the participant was at risk of death at the time of the event/reaction; it does not refer to an event/reaction which hypothetically might have caused death, if it were more severe); • Requires inpatient hospitalization or prolongation of an existing hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Is a medically important event or reaction., From baseline (Day 1) to the last visit, assessed up to 14 months|Occurrence of any clinically significant clinical laboratory abnormalities, Measured as Toxicity Grade ≥1., From baseline (Day 1) to the last visit, assessed up to 14 months|Treatment-emergent, clinically significant changes in vital signs and physical examinations., Vital signs include systolic and diastolic blood pressures, respiratory rate, pulse rate and oral temperature., At specified intervals after each vaccination on Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)

Humoral response to BARS13, IgG antibody titres measured by enzyme-linked immunosorbent assay (ELISA) prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only), as well as at follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose, expressed as follows: Corrected post-dose GMTs of IgG (GP), Prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only)|Humoral response to BARS13, IgG antibody titres measured by enzyme-linked immunosorbent assay (ELISA) prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only), as well as at follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose, expressed as follows: Corrected post-dose GMTs of IgG (GP), At follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose|Humoral response to BARS13, IgG antibody titres measured by enzyme-linked immunosorbent assay (ELISA) prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only), as well as at follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose, expressed as follows: Post-dose geometric mean fold rises (GMFRs) from baseline of IgG (GP), Prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only)|Humoral response to BARS13, IgG antibody titres measured by enzyme-linked immunosorbent assay (ELISA) prior to each vaccination (Day 1 and Day 29 for all cohorts, and Day 57 for Cohort 3 only), as well as at follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose, expressed as follows: Post-dose geometric mean fold rises (GMFRs) from baseline of IgG (GP), At follow-up visits at 4, 8, 16, 24, 32, 40 and 52 weeks post last dose

Blood samples for exploratory immunological analyses, Blood samples will be collected at time points described in the study schedule for exploratory immunological analyses of the humoral response and CMI to BARS13 by measuring: RSV neutralization activity, On Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)|Blood samples for exploratory immunological analyses, Blood samples will be collected at time points described in the study schedule for exploratory immunological analyses of the humoral response and CMI to BARS13 by measuring: CMI PBMC analysis, On Day 1 (all cohorts), Day 29 (all cohorts) and Day 57 (Cohort 3 only)|Blood samples for exploratory immunological analyses, Blood samples will be collected at time points described in the study schedule for exploratory immunological analyses of the humoral response and CMI to BARS13 by measuring: Percentage of participants with RSV-mediated infection detected by: RT-PCR, In participants presenting with symptoms to the general practitioner from baseline (Day 1) to the last visit, assessed up to 14 months|Blood samples for exploratory immunological analyses, Blood samples will be collected at time points described in the study schedule for exploratory immunological analyses of the humoral response and CMI to BARS13 by measuring: Percentage of participants with RSV-mediated infection detected by: IgM (NP), At follow-up visits 4, 8, 16, 24, 32, 40 and 52 weeks post last dose|Blood samples for exploratory immunological analyses, Blood samples will be collected at time points described in the study schedule for exploratory immunological analyses of the humoral response and CMI to BARS13 by measuring: Percentage of participants with RSV-mediated infection detected by: IgG (NP), At follow-up visits 4, 8, 16, 24, 32, 40 and 52 weeks post last dose

Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

ADVA-BARS13-002

2021-05-24

2024-03-31

2024-03-31

2020-12-23

2023-11-02

Q-Pharm Pty Ltd, Herston, Queensland, 4006, Australia|CMAX Clinical Research, Adelaide, South Australia, Australia

{ "Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo": [ { "intervention_type": "DRUG" } ], "Recombinant Respiratory Syncytial Virus Vaccine (BARS13)": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT05299333

Comparison of Pulmonary Telerehabilitation and Physical Activity Recommendations in Patients With Post Covid Fibrosis

https://clinicaltrials.gov/study/NCT05299333

RECRUITING

Rehabilitation plays a very important role in the management of patients with COVID-19, focusing on respiratory and motor functions, and therefore the importance of establishing treatment strategies to ensure optimal recovery of these patients has been emphasized. It has been stated that physical activity recommendations should be clarified for the management of symptoms associated with prolonged COVID-19 Syndrome and for the continuation of activities of daily living. It has been stated that after COVID-19 pneumonia, it is necessary to evaluate the physical functions of patients with long-term follow-up and to establish rehabilitation programs. The importance of being included in the rehabilitation program was emphasized, especially for patients with lung fibrosis. The primary aim of this study was to compare the effects of pulmonary telerehabilitation and physical activity recommendations on exercise capacity and peripheral muscle strength in patients with pulmonary fibrosis due to COVID-19. The secondary aim of this study is to compare the effects of pulmonary telerehabilitation and physical activity recommendations on symptoms, activity and participation in patients with pulmonary fibrosis due to COVID-19.

NO

COVID-19|Pulmonary Fibrosis

OTHER: Exercise

Submaximal exercise capacity, Six minute walk test and, 1 week-8 week|maximal exercise capacity, Incremental shuttle walk test, 1 week-8 week|endurance exercise capacity, endurance shuttle walk test, 1 week-8 week|Peripheral muscle strength, Hand-held dynamometer, 1 week-8 week

Physical activity, Pedometer and activity monitor, 1 week-8 week|Dyspnea, Modified Medical Research Council Dyspnea Scale stratifies severity of dyspnea in respiratory diseases, 1 week-8 week|Fatigue, Fatigue Severity Scale (FSS) is a method of evaluating the impact of fatigue. FSS contains nine statements that rate the severity of your fatigue symptoms. A low value indicates strong disagreement with the statement, whereas a high value indicates strong agreement., 1 week-8 week|Physical fitness, 1 min sit to stand test, 1 week-8 week|Functionality, Post covid-19 functionality scale (PCFS): The PCFS scale stratifies functional status limitation as follows: grade 0 (No functional limitations), grade 1 (Negligible functional limitations), grade 2 (Slight functional limitations), grade 3 (Moderate functional limitations), grade 4 (Severe functional limitations), and grade 5 (death), 1 week-8 week|System usability, System usability scale, 8 week|Emotional status, Hospital anxiety and depression scale, 1 week-8 week|Body composition, Bioelectrical impedence analysis, 1 week-8 week|Activities of daily living, London chest activity of daily living scale: Perceived dyspnea while performing daily living activities is scored between 0-5. A high score indicates greater disability in performing ADLs. The minimum score 0 and maximum total score is 75., 1 week-8 week

Istanbul University - Cerrahpasa (IUC)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2022/25

2022-09-04

2024-06-07

2024-06-07

2022-03-29

2024-02-08

Istanbul University-Cerrahpasa, Istanbul, Turkey

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

NCT05522933

Development and Evaluation of an Online Multidimensional Musculoskeletal Health Programme

https://clinicaltrials.gov/study/NCT05522933

RECRUITING

Globally, work-related musculoskeletal symptoms (WRMSs) have become one of the major public health issues, with musculoskeletal problems contributing to the largest proportion of lost work productivity. Literature has reported that grassroots working-class workers (also known as low-skilled workers) are the most vulnerable group to WRMSs as their work mostly exposes them to the identified risk factors. However, not many intervention studies have been conducted for low-skilled workers to prevent WRMSs. Based on the concept of the multidimensional approach from the literature, and the project team s previous evidence-based research results, this project will modify the project team s face-to-face evidence-based musculoskeletal health promotion program to an online mode with 4 weekly 45-minute workshops for low-skilled workers in the community under the Covid-19 pandemic situation. Thus, the project has the following specific objectives: (i) To determine the feasibility of conducting the proposed online program (ii) To examine the acceptability and satisfaction of the online program from the workers perspectives (iii) To evaluate the potential effects of the online program on the primary outcomes: compliance with exercise regimes, improvement of musculoskeletal literacy, and reduction of the number of body parts with WRMSs (iv) To evaluate the potential effects of the online program on the secondary outcomes: reduction of adverse workstyle, improvement of exercise self-efficacy, mental health, body mass index, hip-waist ratio, and blood pressure measurements

NO

Occupational Health

OTHER: 4 weekly musculoskeletal health promotion workshops with stretching and muscle-strengthening exercise

Compliance with exercise regimes, Exercise regimes will be measured by number of times the participant perform the exercise taught. The higher the number represents a better outcome, Change from the measurement at baseline (T0) to one week after intervention (T1)|Musculoskeletal literacy, Musculoskeletal literacy will be measured by a scale with 25 items with right or wrong answer. Score 1 will be denoted to right answer while score 0 will be denoted to wrong answer. Thus, the higher the score represents a better outcome, Change from the measurement at baseline (T0) to one week after intervention (T1)|Incidence of body parts with work-related musculoskeletal systems (WRMSs), The incidence of body parts with WRMSs will be measured by a modified general Nordic Musculoskeletal questionnaire to collect data about pain, aches or discomfort in different body parts. Score 1 will be denoted to one body part with WRMSs and Score 0 will be denoted to the body part without WRMSs. Thus, the higher the score represents a worse outcome., Change from the measurement at baseline (T0) to one week after intervention (T1)

Adverse workstyle, Adverse workstyle will be measured by a 24-item Chinese Workstyle Short Form for WRMSs with a 5-point Likert scale (0 = almost never and 4 = almost always). It consists of 4 subscales: work through pain (6 items), social reactivity (4 items), demands at work (12 items), and break (2 items). The sums of the subscales are used, the higher the score, the higher frequency of adverse workstyle practices (i.e., the worse of the outcome)., Change from the measurement at baseline (T0) to one week after intervention (T1)|Self-efficacy, The exercise self-efficacy will be measured by a 10-item self-efficacy scale with a 4-point-Likert scale (0=completely inaccurate to 3=completely accurate). The higher the score, the higher levels of self-efficacy (i.e., the better outcome), Change from the measurement at baseline (T0) to one week after intervention (T1)|Mental health, Mental health will be measured by a 21-item depression, anxiety and stress scale (DASS) with a 4-point Likert scale (0=not applicable and 3 = very often). The higher the score represents a worse outcome., Change from the measurement at baseline (T0) to one week after intervention (T1)|Body mass index, Body mass index will be calculated based on the measurement of height (meter) and weight (kilogram) with the formula of kg/m^2. The higher the score represent a worse outcome., Change from the measurement at baseline (T0) to one week after intervention (T1)|Hip-waist ratio, Hip-waist ratio will be calculated based on the measurement of hip and waist circumferences (inches) with the formula of waist circumference / hip circumference. The higher the score represents the worse outcome., Change from the measurement at baseline (T0) to one week after intervention (T1)|Blood pressure, Blood pressure will be measured by both systolic and diastolic blood pressure. The higher the systolic pressure represents a worse outcome. Also, the higher the diastolic pressure represents a worse outcome., Change from the measurement at baseline (T0) to one week after intervention (T1)|Social support and exercise, Social support and exercise will be measured by a 10-item scale with 5-point Likert scale (0=never, and 4=very often). The sum score will be used, the higher the score represents a better outcome., Change from the measurement at baseline (T0) to one week after intervention (T1)

The Hong Kong Polytechnic University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

HSEARS20220624001

2022-08-18

2023-05-31

2023-05-31

2022-08-31

2022-08-31

Residents Mutual Help Centre, Kowloon, Hong Kong

{ "4 weekly musculoskeletal health promotion workshops with stretching and muscle-strengthening exercise": [ { "intervention_type": "OTHER" } ] }

NCT05691933

Regional Block for Upper Abdominal Surgeries

https://clinicaltrials.gov/study/NCT05691933

NOT_YET_RECRUITING

Pain control after major upper abdominal surgeries is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks. Regional blocks allow better pain control and avoid side effects of opioid based pain control

NO

Perioperative Analgesia in Major Upper Abdominal Surgery

PROCEDURE: Block group|PROCEDURE: Morphine infusion

Postoperative morphine requirements for 24 hours, Visual analogue score will be measured every 2 hours, 24 hours postoperatively

Pain assessment, Visual analogue score will be assessed every 2hours postoperatively, 24 hours postoperatively|Rescue analgesia, 0.5 microgram/kg fentanyl will be given if VAS score more than 4, 24 hours postoperatively|Side effects, Any side effect related to fentanyl or block, 24 hours postoperatively

Alexandria University

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

305400

2023-02-01

2023-07-01

2023-07-01

2023-01-20

2023-01-25

{ "Block group": [ { "intervention_type": "PROCEDURE" } ], "Morphine": [ { "intervention_type": "PROCEDURE", "description": "Morphine infusion", "name": "Morphine", "synonyms": [ "Anhydrous morphine", "Morphium", "MXL", "Morphine Chloride", "SDZ 202250", "Arymo", "Morphin", "(5\u03b1,6\u03b1)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "Contin, MS", "Morfina", "SDZ 202 250", "(5R,6S,9R,13S,14R)-4,5-epoxy-N-methyl-7-morphinen-3,6-diol", "(7R,7AS,12bs)-3-methyl-2,3,4,4a,7,7a-hexahydro-1H-4,12-methano[1]benzofuro[3,2-e]isoquinoline-7,9-diol", "(5\u03b1,6\u03b1)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Sevredol", "Oramorph", "SDZ202-250", "Morphine Sulfate (2:1), Anhydrous", "Chloride, Morphine", "Morphine", "Roxanol-T", "Morphgesic", "Oramorph SR", "Morphine Sulfate", "Morphia", "Astramorph", "Zomorph", "(5alpha,6alpha)-17-methyl-7,8-didehydro-4,5-epoxymorphinan-3,6-diol", "Infumorph", "MS Contin", "Sulfate, Morphine", "Morphine Sulfate (2:1), Pentahydrate", "Morphinum", "RMS", "MST", "Kadian", "Duramorph", "SDZ 202-250", "SDZ202250", "SDZ202 250", "(5alpha,6alpha)-didehydro-4,5-epoxy-17-methylmorphinan-3,6-diol", "(\u2212)-morphine" ], "medline_plus_id": "a606006", "generic_names": [ "Morphine" ], "nhs_url": "https://www.nhs.uk/medicines/morphine", "mesh_id": "D009294", "drugbank_id": "DB00295" } ] }

NCT04895033

Brain Responses to Contextual Influences on Drinking Decisions

https://clinicaltrials.gov/study/NCT04895033

RECRUITING

This study is using functional magnetic resonance imaging (fMRI) to examine brain activity associated with making decisions about drinking alcohol in everyday situations, some of which may involve important activities happening the next day. The secondary aims are to determine whether severity of alcohol-related problems is related to brain activity and alcohol choices and to examine how different areas of the brain interact in connected networks.

NO

Alcohol Drinking

BEHAVIORAL: Responsibility condition

Alcohol demand, Participants will report how many standard drinks they would consume at varying prices using a hypothetical Alcohol Purchase Task (APT) procedure. The APT is a validated self-report measure of alcohol consumption (in standard drink units) at escalating prices (18 price intervals, ranging from $0 to $80/drink). Responses on APT are analyzed to generate observed and derived indices of alcohol demand, including: intensity (consumption at free price); breakpoint (maximum price for spent for a single drink); Omax (maximum expenditure on alcohol); and Elasticity (proportionate slope of the alcohol demand curve), During 1 hour MRI scan|Brain activation, Blood-oxygen-level-dependent (BOLD) activity measured by functional magnetic resonance imaging, During 1 hour MRI scan

University of Kansas Medical Center

University of Kansas

ALL

ADULT

OTHER

INTERVENTIONAL

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

STUDY00147117

2023-02-01

2024-07-31

2024-07-31

2021-05-20

2024-06-13

Cofrin Logan Center for Addiction Research and Treatment, Lawrence, Kansas, 66045, United States

{ "Responsibility condition": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04194333

Cone Beam CT Guided Electromagnetic Navigational Bronchoscopy

https://clinicaltrials.gov/study/NCT04194333

CBCTENB

COMPLETED

Electromagnetic navigation bronchoscopy (ENB) is used to access peripheral and central parenchymal lung lesions via endobronchial and transbronchial approach. Traditionally ENB is done under fluoroscopic guidance using C-arm but with development of Cone Beam CT and 3D reconstruction technology, fluoroscopy can be enhanced to much higher resolution and can also provide real time 3D augmentation of the lesion. It also enables the user to obtain a CT of the Chest to confirm the real time location of the lesion and the bronchoscopic biopsy catheter and instruments. This is thought to improve the yield and sensitivity of ENB guided Biopsy of the lung nodules and masses but has not been proven in a prospective trial. With my study, I want to examine the effect of Cone Beam CT with 3D reconstruction on the diagnostic yield and sensitivity of Electromagnetic Navigational Bronchoscopic biopsy of the lung lesions.

NO

Lung Nodule|Lung Mass|Lesion of the Lung

PROCEDURE: Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-Arm

Sensitivity for malignancy, Percentage of malignant lesions accurately diagnosed on biopsy, 1 year Follow up. Prelim results to be reviewed at 3 months|Diagnostic Yield, Percentage of correct underlying diagnosis, 1 year Follow up. Prelim results to be reviewed at 3 months

Procedural Complications, Pneumothorax or Bleeding, 1 year Follow up. Prelim results to be reviewed at 3 months|Procedure Time, Intra-Operative time, 1 year Follow up. Prelim results to be reviewed at 3 months|Radiation Exposure, Will have a record of radiation dose for the Cone Beam CT cases but not for the C-Arm cases. Will compare the radiation exposure in the Intervention arm to the average reported radiation exposure in literature., 1 year Follow up. Prelim results to be reviewed at 3 months

Columbus Regional Health

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

1

2017-08-01

2021-11-02

2021-11-02

2019-12-11

2022-07-21

Columbus Regional Health, Columbus, Indiana, 47201, United States

{ "Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-Arm": [ { "intervention_type": "PROCEDURE" } ] }

NCT04928833

Investigation of the Effects of Pilates Training in Parkinson Patients

https://clinicaltrials.gov/study/NCT04928833

COMPLETED

This study was planned to examine the effects of Pilates training in Parkinson s Patients. The study included 34 Parkinson s patients between Hoehn & Yahr Stage 1-2.5. Pilates training was applied to the Pilates group for 8 weeks, 3 days per week. To the control group; Breathing exercises, active range of motion exercises and relaxation exercises were given as a home program 3 days per week for 8 weeks. It was concluded that Pilates training performed to Parkinson s patients 3 times a week for 8 weeks was effective on core stability, thickness of core muscles, functional exercise capacity, motor functions, freezing, fatigue and QOL.

NO

Parkinson Disease|Pilates|Core Stability|Balance|Quality of Life

OTHER: Pilates Training|OTHER: Control group

Evaluation of the Strength of Core Muscles, The strength of the trunk muscles was evaluated with sit-up and modified push-up tests. The number of times the subjects could perform each test for 30 seconds was recorded. Each measurement was made twice and the best measurement was used in statistical analysis., 8 weeks|Evaluation of the Endurance of Core Muscles, Static endurance of the core muscles was evaluated using the lateral bridge test defined by McGill, the trunk flexor endurance test and the prone bridge test. The time in which the subjects could maintain the test position was recorded in seconds using a stopwatch. Each measurement was made twice and the best measurement was used in statistical analysis. The test was terminated if it disturbed the test position., 8 weeks|Ultrasound Examination of M. Transversus Abdominus and M. Multifidus, M. transversus abdominus (TrA) and m. multifidus (MF) muscles were visualized by ultrasonography and the evaluations were performed by an experienced radiologist who was blind to the case groups. Ultrasound recordings were made using B-mode ultrasound. Each measurement was taken 3 times and the average value of 3 measurements was recorded in mm for statistical analysis., 8 weeks|Evaluation of Lower Extremity Functional Strength, Lower extremity functional strength was evaluated with the 5-Times Sit-and-Stand Test. The test was performed twice, one trial, and the last measurement was used in statistical analysis., 8 weeks|Evaluation of Balance, Balance was evaluated using the Berg Balance Scale (BBS). BBS tests were performed using the materials specified in the directive and in accordance with the instructions. The total score ranges from 0-56, with higher scores indicating better balance., 8 weeks|Evaluation of Functional Mobility, Functional mobility was evaluated using the Timed Up and Go Test (TUG). This test; The duration was recorded and applied during the single-task and dual-task (motor and cognitive). Testing for single task was carried out in accordance with the instruction. In dual-motor duty, while holding an empty tray from the case with both hands; In the dual-cognitive task, he was asked to stand up and walk, turn around and come back and sit on the chair, counting 1 each backwards from a certain number (any number from 20 to 100). The time was recorded with a stopwatch. The test was performed twice, one trial, and the last measurement was used in statistical analysis., 8 weeks|Evaluation of Functional Exercise Capacity, Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). The test was performed in accordance with the American Thoracic Society criteria. Normal values of 6-MWT are calculated approximately according to age, gender, height and weight in healthy adults. In this study, using reference suggested by Gibbons et al. Estimated 6-MWT distance and the rate of reaching the maximal heart rate at the end of 6-MWT were calculated., 8 weeks|Activities of Daily Living and Evaluation of Motor Impairment, Activities of daily living and motor impairment were evaluated with activities of daily living (II) and motor impairment (III) sub-dimensions of the Unified Parkinson s Disease Rating Scale (UPDRS). The total score ranges from 0-108, with a higher score indicating a more serious disorder., 8 weeks|Evaluation of Freezing, The Freezing of Gait Questionnaire (FOGQ) was used to identify and evaluate the subjective perception of Parkinson s patients regarding the severity and effect of freezing on gait performance. The total score ranges from 0-24, with a higher score meaning that a person s walking performance is more affected by freezing., 8 weeks|Evaluation of Fatigue, Fatigue, one of the non-motor findings associated with Parkinson s, was evaluated with the Parkinson s Fatigue Scale-16 (PFS-16). The total score ranged from 16 to 80, and a total of 8 points or more was considered tired., 8 weeks|Evaluation of Quality of Life, Quality of Life was evaluated with Parkinson s Disease Questionnaire-39 (PDQ-39). This questionnaire is the most frequently used specific health status measure in PD patients. The total score ranges from 0-100, and lower scores better reflect perceived quality of life., 8 weeks

Recep Tayyip Erdogan University Training and Research Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2019/10

2019-11-01

2020-02-01

2020-05-01

2021-06-16

2021-06-16

Recep Tayyip Erdogan University, Güneysu, Ri̇ze, 53390, Turkey

{ "Pilates Training": [ { "intervention_type": "OTHER" } ], "Control group": [ { "intervention_type": "OTHER" } ] }

NCT02279433

A First-in-human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of DS-6051b

https://clinicaltrials.gov/study/NCT02279433

COMPLETED

DS-6051b is an orally administered inhibitor of the tyrosine kinases (ROS1) and neurotropic tyrosine kinase receptors (NTRK). This phase 1 first-in-human study evaluates safety and tolerability of DS-6051b in cancer subjects and identify a recommended phase 2 dose (RP2D). In addition, this study will also assess the pharmacokinetic (PK)/pharmacodynamic (PD) profiles and preliminary efficacy of DS-6051b.

NO

Solid Tumors

DRUG: DS6051b

Part 1: Number of participants with dose-limiting toxicities, within 21 days following the first dose of treatment|Tumor response, Tumor response will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1., up to 2 years

Maximum concentration (Cmax) for DS-6051a, At Days 1 and 15 of Cycle 1 (21 days)|Time to maximum concentration (Tmax) for DS-6051a, At Days 1 and 15 of Cycle 1 (21 days)|Area under the concentration-time curve from time zero to t (AUC0-t) for DS-6051a, At Days 1 and 15 of Cycle 1 (21 days)|Change from baseline in QTc interval, ECGs performed to assess QTc interval (ms) at baseline and on study treatment and at the end of treatment visit., within 2 years

AnHeart Therapeutics Inc.

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

DS6051-A-U101

2014-09

2019-03

2019-03

2014-10-31

2020-09-22

HonorHealth Research Institute, Scottsdale, Arizona, 85258, United States|Chao Family Comprehensive Cancer Center of, Orange, California, 92868, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Dana Farber Cancer Inst., Boston, Massachusetts, 02215, United States|New York University, New York, New York, 10016, United States|South Texas Accelerated Research Therapeutics, San Antonio, Texas, 78229, United States

{ "DS6051b": [ { "intervention_type": "DRUG" } ] }

NCT03574233

Ultrasonography Guided Weaning Protocol Development to Predict Successful Weaning

https://clinicaltrials.gov/study/NCT03574233

UNKNOWN

The investigators aimed to develop integrated ultrasound guided mechanical weaning protocol in critically ill patients. The analysis will be taken (1) just before the spontaneous breathing trial in enrolled patients with mechanical ventilation and (2) in patients with tracheostomy who fail ventilator off.

NO

Mechanical Ventilation

Investigation of ultrasound indices associated with the success or failure of mechanical ventilation weaning, * Weaning success: stable without mechanical ventilator support during more than 48 hours * Weaning failure: unstable without mechanical ventilator support within 48 hours A) Type I respiratory failure: high flow oxygen support B) Type II respiratory failure: non-invasive ventilatory support C) Reintubation, within 48 hours

A) In-ICU mortality, 90 days after Ultrasonography|B) In-hospital mortality, 90 days after Ultrasonography|C) Ventilator free day, 90 days after Ultrasonography|D) ICU free day, 90 days after Ultrasonography

Yonsei University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

4-2018-0357

2019-03

2019-05-30

2019-05-30

2018-06-29

2019-02-12

Yonsei University College of Medicine, Seoul, 03722, Korea, Republic of

{}

NCT05690633

Feasibility of Obtaining Pulse Oximetry Readings From the Oropharynx

https://clinicaltrials.gov/study/NCT05690633

ENROLLING_BY_INVITATION

This is a prospective study to evaluate the feasibility of obtaining a pulse oximetry ready from the oropharynx with a standard oximeter probe that has been attached to an oral airway or a tongue blade. The study will compare the values from the peripheral pulse oximeter on a finger, toe, foot or hand with the that from the oropharyngeal oximeter. The study will also compare the saturation from an arterial blood gas (ABG) collected as standard of care with that obtained from the oropharyngeal oximeter.

NO

Surgery|Arterial Catheterization, Peripheral

DEVICE: Pulse oximetry

Accuracy of Pulse Oximetry, Accuracy of pulse oximetry readings (SpO2) as compared with arterial oxygen saturations, Baseline

Joseph D. Tobias

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

STUDY00003039

2024-01-09

2025-12

2025-12

2023-01-19

2024-02-28

Nationwide Children s Hospital, Columbus, Ohio, 43205, United States

{ "Pulse oximetry": [ { "intervention_type": "DEVICE" } ] }

NCT01161433

A Practical Model to Transform Childhood Asthma Care - Spirometry Training in the Primary Care Setting

https://clinicaltrials.gov/study/NCT01161433

COMPLETED

Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, however, few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Even when spirometry is used to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society. The goal of this study is to evaluate the effectiveness of a virtually delivered quality improvement (QI) program. The program is designed to train primary care providers and their medical staff in the use of spirometry to improve pediatric primary care management for children with asthma.

NO

Asthma

BEHAVIORAL: Virtually delivered spirometry quality improvement program

Spirometry test quality, Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society., Seven months

Presence of asthma care plan, To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which written asthma action plans are completed., Seven months|Asthma severity documentation, To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which asthma severity is appropriately documented., Seven months|Appropriate prescription of controller therapy, To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which appropriate controller therapy is prescribed., Seven months|Frequency of office-based spirometry, To test whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which office-based spirometry is used in the management of children with asthma., Seven months

University of Washington

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

32583-E/B|HHSA290200600022, Task order 2

2007-10

2008-09

2008-09

2010-07-13

2010-07-13

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

{ "Virtually delivered spirometry quality improvement program": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02726633

Evaluate the Utility of the ProLung China Test in the Diagnosis of Lung Cancer

https://clinicaltrials.gov/study/NCT02726633

ProLung

UNKNOWN

A Study to evaluate the utility of the ProLung China Test as an adjunct to CT scan in the diagnosis of lung cancer.

NO

Solitary Pulmonary Nodule|Multiple Pulmonary Nodules

Safety and Efficacy of the ProLung China Test, Demonstrate safety and efficacy in the risk stratification of patients with pulmonary lesions identified by CT that are suspicious for lung cancer., The ProLung China Test will be performed within 30 days of a CT Scan that identifies a lung lesion suspicious for lung cancer and evaluated once a patient diagnosis is obtained.

Chinese Alliance Against Lung Cancer

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

CAALC-004-Prolung

2015-05

2017-12

2017-12

2016-04-04

2017-04-04

Nantong Tumor Hospital, Nantong, Jiangsu, 226000, China|Shanghai Dongfang Hospital of Tongji University, Shanghai, Shanghai, 200000, China|Zhongshan Hospital of Fudan University, Shanghai, Shanghai, 200000, China

{}

NCT03569033

Study of Gefapixant (MK-7264) in Acute Cough for Participants With Induced Viral Upper Respiratory Tract Infection (URTI) (MK-7264-013)

https://clinicaltrials.gov/study/NCT03569033

TERMINATED

The purpose of the study is to evaluate the efficacy, safety, and tolerability of gefapixant (MK-7264) in adult participants with induced viral upper respiratory tract infections (URTI).

YES

Acute Cough

DRUG: Gefapixant|DRUG: Placebo

Awake Coughs Per Hour on Day 3, Awake cough frequency (coughs per hour) was assessed by an objective digital cough-counting device (VitaloJAK™ cough monitor) on Day 3., Day 3

Change From Baseline in the Cough Severity Visual Analog Scale (VAS) Score on Day 3, The Cough Severity VAS was scored from 0 to 100 using a 100 mm visual analogue scale. Participants were asked to mark on a 100 mm scale between 0 (no cough) and 100 (the worst cough severity). Cough VAS was evaluated at Baseline and on Day 3., Baseline and Day 3|Change From Baseline in the Mean Total Daily Cough Severity Diary (CSD) Score on Day 3, The Mean Total Daily CSD Score is calculated using the daily CSD instrument, a 7-item, disease-specific, patient-reported outcome measure with a recall period of today (the current day). The measure evaluates frequency of cough (3 items); intensity of cough (2 items); and disruption due to cough (2 items). Each of these 7 items is rated on an 11-point scale, ranging from 0 (best) to 10 (worst), with higher scores indicating greater severity. The total daily CSD score is the sum of these 7 item scores (Min=0, Max=70). The Mean Total Daily CSD Score (the sum of these 7 item scores divided by 7) was calculated at Baseline and on Day 3., Baseline and Day 3|Change From Baseline in the Leicester Cough Questionnaire (LCQ)-Acute Score on Day 3, The LCQ-Acute is a 19-item health-related quality-of-life (HRQoL) questionnaire specific for acute cough which contains three domains (i.e., physical, psychological, and social). It is calculated as a mean score for each domain ranging from 1 to 7, and total score ranging from 3 to 21. Each item on the LCQ-acute assesses symptoms or the impact of symptoms on HRQoL in the last 24 hours using a 7-point Likert scale ranging from 1 to 7. Higher scores indicate better HRQoL. Participants perception of their cough severity was assessed, based on the LCQ-Acute score, at Baseline and on Day 3., Baseline and Day 3|Percentage of Participants Who Experienced One or More Adverse Events (AEs), An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product., Up to 21 days|Percentage of Participants Who Discontinued Treatment Due to an Adverse Event (AE), An AE is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product., Up to Day 7

Merck Sharp & Dohme LLC

ALL

ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

7264-013|MK-7264-013|2017-000472-28

2018-07-04

2018-10-31

2018-11-19

2018-06-26

2019-12-10

2019-12-10

Hvivo Service Limited. Queen Mary BioEnterprises ( Site 0003), London, E1 2AX, United Kingdom

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/33/NCT03569033/Prot_SAP_000.pdf

{ "Gefapixant": [ { "intervention_type": "DRUG", "description": "Gefapixant", "name": "Gefapixant", "synonyms": [ "Gefapixant" ], "drugbank_id": "DB15097", "generic_names": [ "Gefapixant" ] } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT00006487

S0004: Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-stage Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT00006487

COMPLETED

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have limited-stage small cell lung cancer.

NO

Lung Cancer

DRUG: cisplatin|DRUG: etoposide|DRUG: tirapazamine|RADIATION: radiation therapy

Feasibility and Toxicity, If ten or more patients experience either Grade 3 or greater esophagitis or pneumonitis at any dose level, the trial will be stopped. Nine or fewer patients experiencing either of these toxicities will be evidence that the dose can be escalated to the next level., toxicity is assessed weekly

SWOG Cancer Research Network

National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

PHASE1

NETWORK

INTERVENTIONAL

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

CDR0000068318|U10CA032102|S0004

2000-10

2004-07

2004-07

2004-04-02

2012-10-04

MBCCOP - Gulf Coast, Mobile, Alabama, 36688, United States|CCOP - Greater Phoenix, Phoenix, Arizona, 85006-2726, United States|Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix, Arizona, 85012, United States|Veterans Affairs Medical Center - Tucson, Tucson, Arizona, 85723, United States|Arizona Cancer Center, Tucson, Arizona, 85724, United States|University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205, United States|Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock, Arkansas, 72205, United States|Veterans Affairs Medical Center - Long Beach, Long Beach, California, 90822, United States|USC/Norris Comprehensive Cancer Center and Hospital, Los Angeles, California, 90033-0804, United States|Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, 90095-1781, United States|Cancer Center and Beckman Research Institute, City of Hope, Los Angeles, California, 91010-3000, United States|Veterans Affairs Outpatient Clinic - Martinez, Martinez, California, 94553, United States|CCOP - Bay Area Tumor Institute, Oakland, California, 94609-3305, United States|Chao Family Comprehensive Cancer Center, Orange, California, 92868, United States|University of California Davis Cancer Center, Sacramento, California, 95817, United States|University of California Davis Medical Center, Sacramento, California, 95817, United States|CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, 95403, United States|Stanford University, Stanford, California, 94305, United States|David Grant Medical Center, Travis Air Force Base, California, 94535, United States|University of Colorado Cancer Center, Denver, Colorado, 80010, United States|Veterans Affairs Medical Center - Denver, Denver, Colorado, 80220, United States|CCOP - Atlanta Regional, Atlanta, Georgia, 30342-1701, United States|Dwight David Eisenhower Army Medical Center, Fort Gordon, Georgia, 30905-5650, United States|Cancer Research Center of Hawaii, Honolulu, Hawaii, 96813, United States|CCOP - Central Illinois, Decatur, Illinois, 62526, United States|Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines, Illinois, 60141, United States|Loyola University Medical Center, Maywood, Illinois, 60153, United States|University of Kansas Medical Center, Kansas City, Kansas, 66160-7357, United States|CCOP - Wichita, Wichita, Kansas, 67214-3882, United States|Veterans Affairs Medical Center - Wichita, Wichita, Kansas, 67218, United States|Veterans Affairs Medical Center - Lexington, Lexington, Kentucky, 40511-1093, United States|Albert B. Chandler Medical Center, University of Kentucky, Lexington, Kentucky, 40536-0084, United States|MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, 70112, United States|Tulane University School of Medicine, New Orleans, Louisiana, 70112, United States|Louisiana State University Health Sciences Center - Shreveport, Shreveport, Louisiana, 71130-3932, United States|Veterans Affairs Medical Center - Shreveport, Shreveport, Louisiana, 71130, United States|Boston Medical Center, Boston, Massachusetts, 02118, United States|Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain, Massachusetts, 02130, United States|Veterans Affairs Medical Center - Ann Arbor, Ann Arbor, Michigan, 48105, United States|University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, 48109-0752, United States|Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, 48201-1379, United States|Veterans Affairs Medical Center - Detroit, Detroit, Michigan, 48201-1932, United States|Henry Ford Hospital, Detroit, Michigan, 48202, United States|CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, 49503, United States|Providence Hospital - Southfield, Southfield, Michigan, 48075-9975, United States|Veterans Affairs Medical Center - Biloxi, Biloxi, Mississippi, 39531-2410, United States|University of Mississippi Medical Center, Jackson, Mississippi, 39216-4505, United States|Veterans Affairs Medical Center - Jackson, Jackson, Mississippi, 39216, United States|Keesler Medical Center - Keesler AFB, Keesler AFB, Mississippi, 39534-2576, United States|Veterans Affairs Medical Center - Kansas City, Kansas City, Missouri, 64128, United States|CCOP - Kansas City, Kansas City, Missouri, 64131, United States|St. Louis University Health Sciences Center, Saint Louis, Missouri, 63110-0250, United States|CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States|CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65807, United States|CCOP - Montana Cancer Consortium, Billings, Montana, 59101, United States|Veterans Affairs Medical Center - Albuquerque, Albuquerque, New Mexico, 87108-5138, United States|MBCCOP - University of New Mexico HSC, Albuquerque, New Mexico, 87131, United States|Herbert Irving Comprehensive Cancer Center, New York, New York, 10032, United States|Barrett Cancer Center, The University Hospital, Cincinnati, Ohio, 45219, United States|Veterans Affairs Medical Center - Cincinnati, Cincinnati, Ohio, 45220-2288, United States|Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States|CCOP - Columbus, Columbus, Ohio, 43206, United States|Veterans Affairs Medical Center - Dayton, Dayton, Ohio, 45428, United States|CCOP - Dayton, Kettering, Ohio, 45429, United States|Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, 73104, United States|Veterans Affairs Medical Center - Oklahoma City, Oklahoma City, Oklahoma, 73104, United States|Oregon Cancer Center, Portland, Oregon, 97201-3098, United States|Veterans Affairs Medical Center - Portland, Portland, Oregon, 97207, United States|CCOP - Columbia River Program, Portland, Oregon, 97213, United States|CCOP - Greenville, Greenville, South Carolina, 29615, United States|CCOP - Upstate Carolina, Spartanburg, South Carolina, 29303, United States|Veterans Affairs Medical Center - Dallas, Dallas, Texas, 75216, United States|Simmons Cancer Center - Dallas, Dallas, Texas, 75235-9154, United States|Brooke Army Medical Center, Fort Sam Houston, Texas, 78234, United States|University of Texas Medical Branch, Galveston, Texas, 77555-0209, United States|Texas Tech University Health Science Center, Lubbock, Texas, 79423, United States|University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78284-7811, United States|Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio, Texas, 78284, United States|Veterans Affairs Medical Center - Temple, Temple, Texas, 76504, United States|CCOP - Scott and White Hospital, Temple, Texas, 76508, United States|Huntsman Cancer Institute, Salt Lake City, Utah, 84112, United States|Veterans Affairs Medical Center - Salt Lake City, Salt Lake City, Utah, 84148, United States|Eastern Virginia Medical School, Norfolk, Virginia, 23507, United States|CCOP - Virginia Mason Research Center, Seattle, Washington, 98101, United States|Swedish Cancer Institute, Seattle, Washington, 98104, United States|Veterans Affairs Medical Center - Seattle, Seattle, Washington, 98108, United States|CCOP - Northwest, Tacoma, Washington, 98405-0986, United States

{ "Cisplatin": [ { "intervention_type": "DRUG", "description": "cisplatin", "name": "Cisplatin", "synonyms": [ "CDDP", "Platinol", "PLATINUM, DIAMMINEDICHLORO-, (SP-4-2)-", "cis-DDP", "CIS-DIAMMINEDICHLOROPLATINUM", "INT-230-6 COMPONENT CISPLATIN", "CIS-DIAMMINEDICHLOROPLATINUM II", "cis-diamminedichloroplatinum(II)", "(SP-4-2)-DIAMMINEDICHLOROPLATINUM", "Cisplatin", "INT230-6 COMPONENT CISPLATIN", "Cis-DDP", "cis-Platinum II", "cisplatino" ], "medline_plus_id": "a684036", "generic_names": [ "Cisplatin" ], "drugbank_id": "DB00515" } ], "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" } ], "Tirapazamine": [ { "intervention_type": "DRUG", "description": "tirapazamine", "name": "Tirapazamine", "synonyms": [ "SR4233", "SR-4233", "3-Amino-1,2,4-benzotriazine-1,4-dioxide", "WIN 59075", "Tirazone", "NSC 130181", "WIN59075", "3-Amino-1,2,4-benzotriazine 1,4-dioxide", "WIN-59075", "Tirapazamine", "SR 4233", "1,2,4-benzotriazin-3-amine, 1,4-dioxide" ], "mesh_id": "D011838", "generic_names": [ "Tirapazamine" ], "drugbank_id": "DB04858" } ], "radiation therapy": [ { "intervention_type": "RADIATION" } ] }

NCT02866487

Lung Fluid and Peripheral Blood Neutrophil IL-5 Surface Receptor in Children With Asthma

https://clinicaltrials.gov/study/NCT02866487

NAIL-5

COMPLETED

The pattern of lower airway inflammation in asthma is heterogeneous, but in many patients, the polymorphonuclear neutrophil (PMN) is the predominant granulocyte infiltrating the airspaces. Although it is known to have an important function in innate immune defense, the role of the PMN in asthma has not been well elucidated. In work in progress, the investigators have identified the receptor for IL-5 on the surface of bronchoalveolar lavage (BAL) PMNs in a subset of children with severe, treatment-resistant asthma, a characteristic that is not found in peripheral blood neutrophils. While the function of this IL-5 receptor has yet to be determined, preliminary evidence strongly supports a mechanism linking neutrophilic with type 2 inflammation in the lower airways of children with asthma, a discovery that has exciting potential to modify the treatment of asthma. The primary objective of this observational cross-sectional study is to test the overall hypothesis that therapeutic intervention directed against the IL-5R on lung PMNs will decrease inflammation and improve clinical outcomes in patients with poorly controlled asthma. The secondary study objective is to demonstrate that IL-5R expression on lung-infiltrating PMNs is functional, will activate known IL-5R-induced signaling pathways, and will lead to enhanced PMN pro-inflammatory activity including increased PMN recruitment, prolonged survival, degranulation, and release of reactive oxygen species.

NO

Asthma

PROCEDURE: Bronchoscopy

Percent neutrophils bearing surface markers for IL-5 Receptor, The percentage of neutrophils which bear surface markers for the IL5-R in lung fluid and peripheral blood will be compared in children with different asthma phenotypes, 6+ months post bronchoscopy

In vitro analysis of IL-5 Receptor (IL-5 R) function: Signaling via the IL-5 R displayed on neutrophils from the BAL (and if necessary, peripheral blood) following ligand (IL-5) binding, This measure will assess the phosphorylation of STAT 5 and simultaneously phosphorylation of AKT (as a surrogate for activation of PI 3 kinase) following treatment of neutrophils with IL-5 (i.e. IL-5 R engagement). Engagement of the GM-CSF receptor on the neutrophils by its ligand will serve as a control for the capacity of neutrophils to undergo signal transduction in response to ligands. Additional control will be activation (phosphorylation) of STAT 5 on eosinophils responding to IL-5 (i.e IL-5 R engagement). This analysis will be carried out using flow cytometry to evaluate phosphorylation of the indicated signaling intermediates. This analysis will establish whether the IL-5 R on BAL neutrophils is functional (i.e. capable of transducing a signal following ligand binding)., 48-72 hours post bronchoscopy|Measurement of neutrophil degranulation and inflammatory mediator production following IL-5 binding to its receptor on neutrophils isolated from the BAL, Neutrophil activation will assess the production of specific cytokines (e.g. TNFa) and chemokines (e.g. CXCL 10) as well as release of granule contents (e.g. lysozyme and proteases) following IL-5 R engagement. These functions will be assessed by ELISA. Analysis of this parameter will elucidate whether signaling through the IL-5 R results in classical activation of IL-5 R positive neutrophils, the result of which is enhanced injury and inflammation., 48-72 hours post bronchoscopy|Production of Reactive Oxygen Species following IL-5 R engagement, Reactive Oxygen Species will evaluate the generation of ROS by neutrophils following IL-5 R engagement in BAL neutrophils (and if appropriate neutrophils isolated from peripheral blood). This analysis will be carried out using colorimetric analysis of color change in neutrophils exposed to ROS sensitive dye. This analysis will determine if exposure to IL-5 results in ROS production by neutrophils and as a consequence the potential for increased tissue damage to the lungs., 48-72 hours post bronchoscopy|Measurement of neutrophil survival in culture upon IL-5 R engagement in vitro, Neutrophil survival will analyze the survival in culture of neutrophils isolated from the BAL following exposure to IL-5 in vitro. Apoptosis of neutrophils over time in culture will be evaluated by flow cytometry. This analysis will determine whether exposure of lung neutrophils to IL-5 will enhance their survival and therefore the potential of neutrophils activated in response to IL-5 to promote enhanced inflammation and injury., 48-72 hours post bronchoscopy

University of Virginia

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

NAIL-5

2016-08

2018-05-14

2018-05-14

2016-08-15

2022-02-07

University of Virginia Health System, Charlottesville, Virginia, 22908, United States

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

NCT03270787

Study of Compound Danshen Dripping Pills to Treat Acute Mountain Sickness

https://clinicaltrials.gov/study/NCT03270787

COMPLETED

This study is to evaluate the efficacy and safety of compound danshen dripping pills in preventing and treating acute mountain sickness.

NO

Acute Mountain Sickness

DRUG: Placebo|DRUG: Compound danshen dripping pills

The incidence of acute mountain sickness rapid radical to an altitude of 3000m above the plateau region compared to placebo, 7days

Tasly Pharmaceuticals, Inc.

ALL

ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

TCM1421

2016-06-24

2016-07-13

2017-07-13

2017-09-01

2017-09-01

People s Hospital of Tibet Autonomous Region, Damxung, Tibet, 850000, China

{ "Placebo": [ { "intervention_type": "DRUG" } ], "Compound danshen dripping pills": [ { "intervention_type": "DRUG" } ] }

NCT04096287

Safety and Tolerability of PNT001 in Healthy Adults

https://clinicaltrials.gov/study/NCT04096287

COMPLETED

This first in human study is a multi-center, randomized, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intravenous PNT001 in healthy adult participants.

NO

Healthy

BIOLOGICAL: PNT001|DRUG: Placebo

Incidence of Treatment Emergent Adverse Events, assess adverse events during 16 week duration of study, 16 weeks|Incidence of Treatment Emergent Clinical Laboratory Test Abnormalities, measure clinical laboratory values during 16 week duration of study, 16 weeks|Incidence of Treatment Emergent Abnormalities in Physical Examination Findings, observe skin, eyes, ears, nose, throat, cardiac and pulmonary status, abdomen, and extremities for any abnormalities, 16 weeks|Incidence of Treatment Emergent Abnormalities in Neurological Examination Findings, perform a neurological assessment of orientation, cranial nerve function, limb function for presence of involuntary movements, muscle mass, tone, and strength, coordination, reflexes, sensation, joint position, gait, Romberg test, 16 weeks|Incidence of Treatment Emergent Abnormalities in Blood Pressure, measure resting pulse rate as beats per minute, 16 weeks|Incidence of Treatment Emergent Abnormalities in Pulse Rate, measure systolic and diastolic blood pressure in mmHg, 16 weeks|Incidence of Treatment Emergent Abnormalities in 12 lead Electrocardiogram Assessment, measure QT and calculate QTcF value, 16 weeks

Pharmacokinetic properties of PNT001 in Serum, measure concentration of PNT001 in serum, 16 weeks|Pharmacokinetic properties of PNT001 in Cerebrospinal Fluid (CSF), measure concentration of PNT001 in CSF, 28 days

Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - total tau, measure CSF concentrations of total tau, 28 days|Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - cis-pT231 tau, measure CSF concentrations of cis-pT231 tau, 28 days|Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - total pT231 tau, measure CSF concentrations of total pT231 tau, 28 days|Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - NfL, measure CSF concentrations of Neurofilament Light Chain (NfL), 28 days|Pharmacodynamic effects of PNT001 in Serum - NfL, measure serum concentrations of Neurofilament Light Chain (NfL), 28 days|Immunogenicity of PNT001 - ADA, measure presence of antidrug antibodies (ADA) in serum, 16 weeks

Pinteon Therapeutics, Inc

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

PNT001-001

2019-09-17

2021-02-15

2021-02-15

2019-09-19

2021-02-23

Woodland Research Northwest, Rogers, Arkansas, 72758, United States|Pacific Research Network, Inc., San Diego, California, 92103, United States|Hassman Research Institute, Marlton, New Jersey, 08053, United States|Worldwide Clinical Trials, San Antonio, Texas, 78217, United States

{ "PNT001": [ { "intervention_type": "BIOLOGICAL", "description": "PNT001", "name": "PNT001", "synonyms": [ "PNT001", "" ], "drugbank_id": "DB18375", "generic_names": [ "PNT001" ] } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT02571387

MindOb: A 12-month Computerized Mindfulness-based Intervention for Obese Individuals

https://clinicaltrials.gov/study/NCT02571387

MindOb

UNKNOWN

The purpose of this study is to evaluate the efficacy of a daily 12-month computerized mindfulness-based intervention in obese patients diagnosed with Binge Eating Disorder (BED) on: impulsive eating, motivation toward exercise, and weight loss.

NO

Obesity|Binge-Eating Disorder

BEHAVIORAL: Mindfulness-based intervention|BEHAVIORAL: Sham meditation

Change in impulsive eating (TFEQ-R18 uncontrolled eating subscale), From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

Change in motivational regulation toward exercise (BREQ-II), Behavioral Regulation in Exercise Questionnaire-II (5 subscales): amotivation, external regulation, introjected regulation, identified regulation, intrinsic regulation, From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.|Change in self-reported physical activity (IPAQ), International Physical Activity Questionnaire short form, From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.|Change in pedometers-measured physical activity, Pedometers on a daily basis for 7 days (ref: ONWalk100), From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.|Change in self-reported anxiety and depression (HADS), Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression, From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.|Change in mindfulness skills (MAAS, AAQ-II), Combination of scores in Mindful Attention Awareness Scale; Acceptance and Action Questionnaire-II, From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.|Change in daily mindful responding (DMRS), Daily Mindful Responding Scale on a daily basis for 7 days (at baseline, 6 months and 12 months), From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.|Change in plasma concentration of leptin, adiponection and BDNF, From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.|Change in body mass index (kg/m2), BMI as measured by a physician, From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.|Change in food intake, Dietary survey on a daily basis for 7 days (at baseline, 6 months and 12 months), From baseline to study completion (12 months). Assessments at baseline, 6 months and 12 months.

Compliance to the intervention (number of sessions done divided by number of session due), From baseline to study completion (12 months). Assessments at baseline, 1 month, 6 months and 12 months.

University of Paris 5 - Rene Descartes

Hospital Ambroise Paré Paris|Nestlé Foundation

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

EA4057-mindob

2016-05

2019-10

2019-10

2015-10-08

2018-12-26

Hôpital Ambroise Paré, Assistance Publique-Hôpitaux de Paris, Boulogne-Billancourt, 92100, France

{ "Mindfulness-based intervention": [ { "intervention_type": "BEHAVIORAL" } ], "Sham meditation": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00256087

The Effect of Prophylactic Probiotic Lactobacilli in Enteral Feeding on Nosocomial Pneumonia Rates in Critically Ill Patients

https://clinicaltrials.gov/study/NCT00256087

COMPLETED

To assess the effect of addition of probiotic Lactobacilli to standard enteral feeding on infection rates and feeding efficacy in critically ill patients. The study hypothesis is that critically ill patients who receive the addition of probiotic lactobacilli to the enteral feed will lead to a reduced rate of hospital acquired infections. The null hypothesis is that there will be no significant difference in the rate of hospital acquired infection in critically ill patients who receive enteral feeding with or without the addition of probiotic Lactobacilli.

NO

Critical Illness

DRUG: Probiotic Lactobacillus|OTHER: Lactose Powder

To determine if enteral feeding plus probiotic Lactobacilli are associated with a reduced rate of nosocomial pneumonia in critically ill patients., 28 days

To determine the incidence of complications of enteral feeding with and without added probiotic Lactobacilli., 28 Days|To assess if the efficacy of enteral feeding in critically ill patients is improved by the addition of probiotic Lactobacilli., 28 days

Melbourne Health

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2004.067

2005-01

2010-01

2010-01

2005-11-21

2015-11-20

Intensive Care Unit Royal Melbourne Hospital Grattan Street, Parkville, Victoria, 3050, Australia

{ "Probiotic Lactobacillus": [ { "intervention_type": "DRUG" } ], "Lactose Powder": [ { "intervention_type": "OTHER" } ] }

NCT02554487

Early Sleep Apnea Treatment in Stroke

https://clinicaltrials.gov/study/NCT02554487

eSATIS

UNKNOWN

Investigating the interrelation of stroke and sleep-disordered breathing (SDB) is of major importance. First because of the high occurrence rate of stroke and the fact that it is a frequent cause of long-term disability in adulthood. Second because SDB (obstructive, central and mixed forms) affects more than 50% of stroke survivors and has a detrimental effect on clinical stroke outcome. Third, spontaneous and learning-dependent sleep-associated neuroplasticity may be affected by SDB following stroke worsening stroke rehabilitation. Therefore, it is crucial to investigate whether early treatment of SDB with Adaptive Servo-Ventilation (ASV), the treatment device of choice to treat obstructive, central and mixed forms of SDB, has a beneficial effect on the evolution of the lesion volume and on clinical stroke outcome. To this end, the investigators recruit and prospectively follow 3 groups of patients with ischemic stroke over 1 year. During the first night after hospital admission due to acute stroke, nocturnal breathing is assessed by means of a respiratory polygraphy. Patients with significant sleep disordered breathing, defined as an Apnea-Hypopnea-Index (AHI) > 20/h, are randomized to ASV treatment or no treatment (sSDB ASV+ or sSDB ASV-). ASV treatment starts the second night following hospital admission and ends 90 days later. Stroke patients without SDB (AHI < 5 / h) serve as a control group (no SDB) to observe the evolution of the lesion volume and stroke outcome without the additional burden of SDB. Lesion volume one day after hospital admission due to acute stroke (after potential lysis therapy) measured by Diffusion Weighted Imaging will be subtracted from lesion volume measured by T2-weighted volumetry assessed 90(+/-7) days following stroke and compared between patients with and without ASV treatment (sSDB ASV+ and sSDB ASV-) as well as patients without SDB (no SDB). Short- and long-term clinical stroke outcomes are assessed by clinical scales and questionnaires 4 to 7 days, 3 months and 1 year following stroke. Cognitive outcome is assessed during hospitalization (within the first week following stroke) and after the treatment period of 90 days by neuropsychological tests assessing attention and memory. In addition, baseline assessment of physiological parameters such as blood pressure and endothelial function/arterial stiffness are assessed during the first weeks following stroke and at the end of the treatment period, i.e. approximately 90 days following stroke.

NO

Sleep Apnea, Obstructive|Sleep Apnea, Central|Stroke

DEVICE: AirCurveTM10 CS PACEWAVE Adaptive-Servo-Ventilator (ResMed Ldt., Australia)

Infarct growth from baseline to 90 day following stroke: difference in lesion volume [ccm] assessed by Diffusion Weighted Imaging (DWI) at baseline and T2-weighted imaging at day 90 following stroke, The day after admission and potential lysis therapy, at 4 to 7 days following stroke and 90 (+/-7 ) days following stroke

Relative salvage of the penumbra volume from the day after lysis therapy to day 4-7 following stroke will be compared between the three patients groups (sSDB ASV+, sSDB ASV-, no SDB), The day after admission/potential lysis therapy and at 4 to 7 days following stroke|Differences in spatial/temporal dynamics of resting state connectivity between the three patients groups: sSDB ASV+, sSDB ASV-, no SDB, The day after admission/potential lysis therapy, at day 4-7 and day 90 following stroke|Differences in clinical outcome between the three patients groups, sSDB ASV+, sSDB ASV- and no SDB, assessed by the NIHSS, Barthel Index and the modified Rankin scale, Pre-stroke assessment during hospitalization and post-stroke assessments at day 90 and 1 year following stroke|Differences in blood pressure measurements (absolute values and variability) during hospitalisation, during a 3-week period following dismissal and during a 3-week period 90-days following stroke., 3 weeks following hospital discharge (baseline) and 3-weeks before end of intervention period (~day 69-90).|Differences in endothelial functioning/arterial stiffness at day 2 (baseline) and at 90 days following stroke, 3 weeks following hospital discharge (baseline) and 3-weeks before end of intervention period (~day 69-90).|Stroke patients tolerance of and compliance to the ASV intervention during the acute (within the first week following stroke) and subacute to chronic phase (within the first 3 months following stroke), Tolerance and compliance are assessed during hospitalization (between 2 and 7 following stroke), at a follow-up control visit (between day 28-42) and at the end of the treatment period (day 83-97).

Insel Gruppe AG, University Hospital Bern

Swiss National Science Foundation|TROPOS Stiftung für Humane Verhaltensforschung

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

016/15|2734|320030_149752|SNCTP000001521|33IC30_166827

2015-08-13

2022-03-05

2022-11

2015-09-18

2022-06-29

Clinic universitaire de physiologie, sommeil et exercice, Centre Hospitalier Universitaire (CHU) de Grenoble, Grenoble, 38043, France|Department and Out-Patient Care of Neurology, Charité Center Neurology, Neurosurgery and Psychiatry CC 15, Department of Neurology with Experimental Neurology, Center for Stroke Research Berlin (CSB), Berlin, 10117, Germany|Universitätsmedizin der Johannes Gutenberg-Universität Mainz, HNO-Universitätsklinik, Klinik und Poliklinik für Neurologie, Mainz, 55131, Germany|Federal State Budgetary Institution Almazov National Medical Research Centre of the Ministry of Health of the Russian Federation, Saint Petersburg, 197341, Russian Federation|Department of Neurology, Pulmonary Medicine and Institute of Diagnostic and Interventional Neuroradiology, Bern University Hospital, Bern, 3010, Switzerland|Neurology Department, Cantonal Hospital St.Gallen, St.Gallen, 9007, Switzerland

{ "AirCurveTM10 CS PACEWAVE Adaptive-Servo-Ventilator (ResMed Ldt., Australia)": [ { "intervention_type": "DEVICE" } ] }

NCT01309087

Airway Epithelium Gene Expression in the Diagnosis of Lung Cancer: AEGIS CLIA

https://clinicaltrials.gov/study/NCT01309087

AEGIS

COMPLETED

The primary objective of this study is to substantiate prediction accuracy(with a tighter 95% confidence interval compared to current diagnostic modalities), of a lung cancer biomarker for risk stratification of patients into high and low risk categories to aid in clinical evaluation of the patient.

NO

Lung Cancer

Primary Lung Cancer, One year from enrollment

Allegro Diagnostics, Corp.

Beth Israel Deaconess Medical Center|Columbia University|Vanderbilt University|University of British Columbia|University of Pennsylvania|New York University|Temple University|Indiana University|University of Alabama at Birmingham|University of Virginia|University of Missouri-Columbia|Louisiana State University Health Sciences Center in New Orleans|University of Dublin, Trinity College|Georgia Lung Associates PC

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

ADx-0001: AEGIS CLIA

2009-01

2013-05

2013-05

2011-03-04

2014-03-26

University of Alabama, Birmingham, Alabama, 35294, United States|Georgia Lung Associates, Austell, Georgia, 30106, United States|Indiana University, Indianapolis, Indiana, 46202, United States|LSU, New Orleans, Louisiana, 70112, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|University of Missouri, Columbia, Missouri, 65203, United States|New York University, New York, New York, 10016, United States|Columbia University, New York, New York, 10032, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Temple University, Philadelphia, Pennsylvania, 19140, United States|Vanderbilt University, Nashville, Tennessee, 37232, United States|University of Virginia, Charlottesville, Virginia, 22908, United States|University of British Columbia, Vancouver, British Columbia, Canada|Trinity College, Dublin, 8, Ireland

{}

NCT03226587

Acute Effects of Whole Body Blue Light Exposure on Blood Pressure

https://clinicaltrials.gov/study/NCT03226587

COMPLETED

Ultraviolet light exposure was shown to be able to release nitric oxide from the skin into the blood stream and lead to an acute decrease in blood pressure and increase in vascular function. Additionally, preliminary work indicates that UV free blue light also releases nitric oxide in the skin mediating similar effects as seen with ultraviolet light A(UVA). It is the goal of the present experimental study to investigate the hemodynamic effects of whole body blue light exposure including blood pressure, endothelial function and vascular stiffness. Therefore, healthy volunteers will be exposed to 30 minutes whole body blue light (453 nm wavelength) and the change in blood pressure and endothelial function (Flow mediated dilation (FMD)), heart rate, forearm-blood flow, forearm vascular resistance central blood pressure and vascular stiffness ( pulse wave analysis by sphygmocor) will be measured. In this randomized controlled cross-over study, 20 healthy subjects aged 30 to 60 years will participate.

NO

Blue Light

PROCEDURE: Blue light|PROCEDURE: control exposure

Change of peripheral blood pressure, Change of peripheral blood pressure as measured before, during and up to 2 hours after 30 min blue light as compared to control, baseline, during 30 min exposure and 2 hours thereafter

Change in endothelial function, measured by flow mediated dilation (FMD) before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline heart rate, measured by electrocardiography (ECG) before, during and up to 2 hours after 30 min blue light as compared to control, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline forearm blood flow, measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline forearm vascular resistance, measured by ultrasound before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline central blood pressure, measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline vascular stiffness, measured by applanation tonometry before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline NO-species, determined by chemiluminescence before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline Cortisol, measured before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter|Change from baseline Endorphins, measured before, immediately after 30 min exposure and at 2 h thereafter, baseline, during 30 min exposure and 2 hours thereafter

Heinrich-Heine University, Duesseldorf

Philips GmbH, Innovative Technologies, Aachen|Klinik für Unfall - und Handchirurgie, Universitätsklinikum Düsseldorf

MALE

ADULT

OTHER

INTERVENTIONAL

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

15-035

2016-08

2017-08

2017-08

2017-07-24

2017-11-09

Division of Cardiology, Pulmonary Disease and Vascular Medicine, Düsseldorf, NRW, 40225, Germany

{ "Blue light": [ { "intervention_type": "PROCEDURE" } ], "control exposure": [ { "intervention_type": "PROCEDURE" } ] }

NCT00270387

A Study of Short-Term Outcomes and Economic Impact For Patients With Worsening Congestive Heart Failure When Natrecor (Nesiritide) is Added to Standard-Care Therapy, Compared to Administration of Placebo With Standard-Care Therapy

https://clinicaltrials.gov/study/NCT00270387

COMPLETED

The purpose of this pilot study is to compare the clinical effects, safety profile, and economic impact of standard therapy plus Natrecor® (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to standard therapy plus placebo in patients who present to the Emergency Department with worsening congestive heart failure (CHF) and are treated in the Emergency Department /Observation Unit.

NO

Cardiomyopathies|Heart Failure, Congestive|Dyspnea, Paroxysma

DRUG: Natrecor (nesiritide)

Natrecor® can be safely administered in outpatient settings with blood pressure monitoring; Number of hospital readmissions and average length of stay in the hospital

Economic Impact on hospitals of earlier and more aggressive treatment in the Emergency Department with Natrecor® added to standard care

Scios, Inc.

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

CR005209

2001-01

2002-01

2005-12-26

2012-12-13

{ "Natrecor (nesiritide)": [ { "intervention_type": "DRUG" } ] }

NCT02103387

Five Sessions Intervention to Facilitate Adaptation to Breast Cancer

https://clinicaltrials.gov/study/NCT02103387

COMPLETED

To test the effects of 2 different 5-wk stress management interventions (cognitive behavioral training or relaxation training) vs. a time-matched 5-wk health education condition on psychosocial adaptation and physiological adaptation in women being treated for breast cancer. Participants assigned to either of the stress management conditions will show improved psychosocial adaptation and physiological adaptation compared to those assigned to the health education condition.

NO

Breast Cancer

BEHAVIORAL: Cognitive Behavioral Training|BEHAVIORAL: Relaxation Training|BEHAVIORAL: Health Education Control

Negative affect as measured by the Affect Balance Scale- Negative Affect subscale, Change from baseline to 12-month follow-up in the Affect Balance Scale- Negative Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Negative Affect subscale (i.e., depression, hostility, guilt, anxiety) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more negative affect. Possible scores range from 0-5., Changes in scores from baseline to 12-month follow-up|Positive affect as measured by the Affect Balance Scale- Positive Affect subscale, Change from baseline to 12-month follow-up in the Affect Balance Scale- Positive Affect subscale. The Affect Balance Scale includes 40 adjectives assessing negative and positive mood. The Positive Affect subscale (i.e., affection, contentment, vigor, joy) will be used. Each emotional state is rated on a Likert Scale (0=never to 5= always) based on the past week and items are averaged, with higher scores indicating more positive affect. Possible scores range from 0-5., Changes in scores from baseline to 12-month follow-up|Social disruption as measure by the Sickness Impact Profile- Social Interaction subscale, Change from baseline to 12-month follow-up in the Sickness Impact Profile- Social Interaction subscale, a 16-item subscale measuring the level of disruption in social activities. Respondents are asked statements regarding social disengagement as they specifically apply to their breast cancer (e.g., I am doing fewer social activities with groups of people ) over the past few weeks, and are asked to respond either No (0) or Yes (1), this applies to me. Scores are summed, with higher scores indicating greater social disruption. Possible scores range from 0-16., Changes in scores from baseline to 12-month follow-up

Physiological Adaptation, Change from baseline to 12 month follow-up in physiological adaptation (decreased serum cortisol, and increased Th1 cytokine production and lower Th2 cytokine production following anti-CD3 stimulation of peripheral blood mononuclear cells (PBMCs), 12 month follow-up

University of Miami

National Cancer Institute (NCI)

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

20060496|2R01CA064710

2007-01-02

2014-02-25

2014-02-25

2014-04-03

2020-11-10

Department of Psychology, Coral Gables, Florida, 33124, United States

{ "Cognitive Behavioral Training": [ { "intervention_type": "BEHAVIORAL" } ], "Relaxation Training": [ { "intervention_type": "BEHAVIORAL" } ], "Health Education Control": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05556187

Automated Oxygen Titration at Home in Patients With COPD on Home Oxygen

https://clinicaltrials.gov/study/NCT05556187

DaiLiHOT_2

COMPLETED

Twelwe patients with COPD and long term oxygen treatment (LTOT) will be included in the study. An automated home oxygen titrations (HOT) device will be attached to the patient´s home oxygen equipment. For 2x4 consequent days, the patients will be monitored and saturations, oxygen flow and physical activity level will be registered. In randomized order, the patients will use their usual fixed oxygen dose or automated oxygen titration during the first four days and then crossover. The monitoring consists of a wrist pulse oximeter (register pulse and saturation which is send to the HOT device) and a physical activity sensor attached to the patient s knee. At study start and after both of the four days the patients´dyspnea and QoL will be assessed. After the study period the patients will in an explorative design based on qualitative methodology be interviewed in order to explore the patients experiences with automated oxygen titration during daily activity and on dyspnea.

NO

COPD|Hypoxemia

OTHER: Individualized automated oxygen titration

Feasibility of using automated oxygen titration at home, Automated oxygen titration during daily living will be considered feasible if 1. Data is successfully transmitted from the wrist pulse oximeter to O2matic HOT and further to the cloud solution (<10 % data loss). 2. The patients are wearing the wrist pulse oximeter for more than 50 % of the daytime (08:00 - 20:00) 3. The time spent within acceptable SpO2-interval is statistically different between arms and in favor of automated oxygen titration with a difference of at least 10 percentage difference in time. 4. The patients are at least as active with O2matic HOT as with conventional oxygen therapy, measured by SENS activity monitor. 5. The patients are safe with no serious adverse events, including hypercapnia leading to unscheduled healthcare contacts., Immediately after the 2x4 days intervention

Change in CCQ-score, The difference in CCQ-score after four days using automated oxygen titration compared to usual fixed dose., Immediately after the intervention|Physical activity, Difference in physical activity level (time spend walking and standing vs sitting or lying). Steps taken., Immediately after the intervention

Hvidovre University Hospital

Bispebjerg Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

DaiLiHOT_2

2023-01-10

2023-12-29

2023-12-29

2022-09-27

2024-01-31

Linette Marie Kofod, Hvidovre, 2650, Denmark

{ "Individualized automated oxygen titration": [ { "intervention_type": "OTHER" } ] }

NCT02573987

MEOPA Versus Local Anesthesia for Analgesia During Chorionic Villus Sampling.

https://clinicaltrials.gov/study/NCT02573987

MELIBIO

COMPLETED

determine if efficiency of MEOPA anesthesia is at least equivalent to local anesthetics into the chorionic villus sampling in the first trimester of pregnancy

NO

Pain

DRUG: Oxygen/nitrous oxide equimolar mix|DRUG: Lidocaine

Analgesia efficiency, assessment of pain with visual analog scale, 5 min after procedure

assessment of anxiety, assessment of anxiety with visual analog scale, 5 min after biopsy

Hospital St. Joseph, Marseille, France

FEMALE

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

A121414-31

2013-03-13

2015-04

2016-12-27

2015-10-12

2018-01-05

Hôpital St Joseph, Marseille, 13008, France

{ "Oxygen/nitrous oxide equimolar mix": [ { "intervention_type": "DRUG" } ], "Lidocaine": [ { "intervention_type": "DRUG", "description": "Lidocaine", "name": "Lidocaine", "synonyms": [ "Boots Haemorrhoid", "2-(Diethylamino)-2',6'-acetoxylidide", "2-2EtN-2MePhAcN", "\u03b1-diethylamino-2,6-dimethylacetanilide", "Xylocaine", "Lidocaine Monohydrochloride, Monohydrate", "Lidocaine Carbonate", "Xyloneural", "2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide", "Ztlido", "EMLA", "Lidocaina", "Lidocaine", "2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide", "Covonia", "Xylopract", "Nulbia", "Lidoca\u00edna", "Octocaine", "Lidocainum", "LMX4", "Bonjela", "Lidocaine Hydrochloride", "Dalcaine", "Lidocaine Sulfate (1:1)", "Anbesol", "Perinal", "Anusol", "Lidocaine Monohydrochloride", "Germaloids", "Iglu", "Xylesthesin", "Lidocaine Monoacetate", "Lignocaine", "Calgel", "Lidocaine Carbonate (2:1)", "Denela", "Lidocaine Hydrocarbonate", "alpha-diethylamino-2,6-dimethylacetanilide", "Xylocitin", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Xylocaine", "Lidocaine Viscous", "Xylocaine", "Lidocaine Viscous", "Senstend", "Emla", "Fortacin", "Lidocaine/prilocaine", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort" ], "nhs_url": "https://www.nhs.uk/medicines/lidocaine-for-piles-and-itchy-bottom", "generic_names": [ "Lidocaine", "Lidocaine Patch", "Lidocaine Patch", "Lidocaine Viscous", "Lidocaine Viscous", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone" ], "mesh_id": "D061567", "drugbank_id": "DB00281", "wikipedia_url": "https://en.wikipedia.org/wiki/Lidocaine" } ] }

NCT00413387

Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)

https://clinicaltrials.gov/study/NCT00413387

COMPLETED

The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.

NO

Bronchial Asthma

DRUG: beclomethasone dipropionate plus formoterol fumarate combination|DRUG: budesonide plus formoterol combination

Morning Peak Expiratory Flow (PEF) daily measured by patients., morning approximately 8:00

Evening PEF measured by patients daily., evening approximately 20:00|FEV1 measured by patients daily., morning and evening|Standard pulmonary function tests measured at clinics at 2, 4, 8 and 12 weeks., morning before drug intake|Change in FEV1 and PEF from pre-dose to 5, 15, 30 and 60 minutes after study drug intake at week 0 and 12., morning post drug intake|Symptoms scores measured by patients daily., morning and evening|symptoms free days measured by patients daily., daily|Use of relief salbutamol measured by patients daily., daily|Frequency of asthma exacerbations evaluated at 2, 4, 8 and 12 weeks., morning of the visits retrospective assessment|Adverse event and adverse drug reaction daily., morning of visits retrospective assesment|ECG (with QTc interval)at 0 and 12 weeks., morning of start and end of treatment visits|Vital signs (heart rate and blood pressure) at 2, 4, 8 and 12 weeks, morning of visits|Use of relief salbutamol., daily|Frequency of asthma exacerbations., at visits

Chiesi Farmaceutici S.p.A.

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

MC/PR/033011/002/03

2004-09

2005-08

2005-10