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NCT05630573

A Study of TNM001 in Chinese Healthy Preterm and Term Infants

https://clinicaltrials.gov/study/NCT05630573

COMPLETED

The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants. The main questions it aims to answer are: * the safety and tolerability of TNM001 injection * the pharmacokinetic (PK) profile of TNM001

NO

Respiratory Syncytial Virus Infections

BIOLOGICAL: TNM001|BIOLOGICAL: Placebo

Safety and tolerability of TNM001 Injection, Type and incidence of adverse events and serious adverse events, 150 days post dose

Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001, The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001, 150 days post dose|Maximum Observed Serum Concentration (Cmax) of TNM001, The Cmax is the maximum observed serum concentration of TNM001, 150 days post dose|Terminal Elimination Half Life (t1/2) of TNM001, Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum, 150 days post dose|Serum anti-RSV neutralizing antibodies titer levels in each dose cohort, To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline), 150 days post dose|Anti-drug antibody (ADA) positive rate of TNM001, The evaluation indicator of immunogenicity is the ADA positive rate in subjects, 150 days post dose

Lower respiratory tract infection(LRTI), The incidence of LRTI, 150 days post dose

Zhuhai Trinomab Pharmaceutical Co., Ltd.

ALL

CHILD

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

TNM001-201

2022-10-25

2023-06-30

2023-06-30

2022-11-29

2024-06-21

The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, 050000, China|Hunan Provincial People s Hospital, Changsha, Hunan, 410005, China|The Third Xiangya Hospital of Central South University, Changsha, Hunan, 410006, China|Linfen People s Hospital, Linfen, Shanxi, 041000, China|Yuncheng Central Hospital, Yuncheng, Shanxi, 044099, China|West China Second University Hospital, Sichuan University, Chengdu, Sichuan, 610041, China

{ "TNM001": [ { "intervention_type": "BIOLOGICAL" } ], "Placebo": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00158873

Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

https://clinicaltrials.gov/study/NCT00158873

COMPLETED

The study will evaluate the pharmaco-economic consequences of the use of a remifentanil based regimen compared with a conventional sedative based regimen in terms of duration of mechanical ventilation, length of stay in ICU, difference in extubation time and use of concomitant sedative agents.

NO

Sedation

DRUG: midazolam|DRUG: lorazepam|DRUG: fentanyl|DRUG: morphine|DRUG: remifentanil|DRUG: propofol

Health Outcome: Duration of time on mechanical ventilation

Health Outcome: length of stay in ICU, in hospital, requirement of opioid and sedative agents, duration of extubation process. Safety: haemodynamics and adverse events. Efficacy: sedation and pain scores

GlaxoSmithKline

ALL

ADULT, OLDER_ADULT

PHASE4

INDUSTRY

INTERVENTIONAL

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

101653

2004-09

2005-09-12

2008-10-16

GSK Investigational Site, Alkmaar, 1815 JD, Netherlands|GSK Investigational Site, Amsterdam, 1081 HV, Netherlands|GSK Investigational Site, Apeldoorn, 7334 DZ, Netherlands|GSK Investigational Site, Den Bosch, 5211 RW, Netherlands|GSK Investigational Site, Den Haag, 2512 VA, Netherlands|GSK Investigational Site, Dordrecht, 3318 AT, Netherlands|GSK Investigational Site, EDE, 6716 RP, Netherlands|GSK Investigational Site, Eindhoven, 5623 EJ, Netherlands|GSK Investigational Site, Haarlem, 2035 RC, Netherlands|GSK Investigational Site, Helmond, 5707 HA, Netherlands|GSK Investigational Site, Hengelo, 7555 DL, Netherlands|GSK Investigational Site, Rotterdam, 3015 GJ, Netherlands|GSK Investigational Site, Tiel, 4002 WP, Netherlands|GSK Investigational Site, Venlo, 5912 BL, Netherlands|GSK Investigational Site, Zwolle, 8011 JW, Netherlands

{ "Midazolam": [ { "intervention_type": "DRUG", "description": "midazolam", "name": "Midazolam", "synonyms": [ "Midazolam", "Midazolam Hydrochloride", "Nayzilam", "Midazolamum" ], "medline_plus_id": "a621044", "generic_names": [ "Midazolam" ], "mesh_id": "D018757", "drugbank_id": "DB00683", "wikipedia_url": "https://en.wikipedia.org/wiki/Midazolam" } ], "Lorazepam": [ { "intervention_type": "DRUG", "description": "lorazepam", "name": "Lorazepam", "synonyms": [ "Orfidal Wyeth", "WY4036", "Sedicepan", "Somagerol", "Wyeth, Orfidal", "Apo Lorazepam", "Lorazepam Neuraxpharm", "Apo-Lorazepam", "Loracepam", "Duralozam", "Laubeel", "Donix", "Von Ct, Lorazep", "Novo-Lorazem", "Tolid", "Lorazep Von Ct", "Medical, Lorazepam", "Sinestron", "Nu-Loraz", "o-Chloroxazepam", "WY 4036", "Durazolam", "Nu Loraz", "Idalprem", "Lorazepam Ratiopharm", "Temesta", "o-Chlorooxazepam", "Lorazepam-Neuraxpharm", "Lorazepam", "WY-4036", "Novo Lorazem", "Lorazepam-Ratiopharm", "T\u00e9mesta", "Lorazepam Medical", "Ativan" ], "medline_plus_id": "a682053", "generic_names": [ "Lorazepam" ], "nhs_url": "https://www.nhs.uk/medicines/lorazepam", "mesh_id": "D018757", "drugbank_id": "DB00186" } ], "Fentanyl": [ { "intervention_type": "DRUG", "description": "fentanyl", "name": "Fentanyl", "synonyms": [ "Fentanyl CII", "Abstral", "R 4263", "Fentanilo", "Phentanyl", "N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)propanamide", "Fentora", "1-Phenethyl-4-(N-phenylpropionamido)piperidine", "Durogesic", "1-phenethyl-4-N-propionylanilinopiperidine", "Fentanyl", "R-4263", "R4263", "Transmucosal Oral Fentanyl Citrate", "N-(1-Phenethyl-piperidin-4-yl)-N-phenyl-propionamide", "N-(1-phenethyl-4-piperidyl)propionanilide", "N-(1-phenethyl-4-piperidinyl)-N-phenylpropionamide", "N-(1-phenethylpiperidin-4-yl)-N-phenylpropionamide", "Lazanda", "Fentanil", "Fentanyl Citrate", "N-phenethyl-4-(N-propionylanilino)piperidine", "Sublimaze", "Fentanila", "Duragesic", "Fentanest", "Fentanylum", "Fentanyl Patch", "Duragesic", "Fentanyl Patch", "Duragesic" ], "medline_plus_id": "a612015", "generic_names": [ "Fentanyl", "Fentanyl Patch", "Fentanyl Patch" ], "nhs_url": "https://www.nhs.uk/medicines/fentanyl", "mesh_id": "D018686", "drugbank_id": "DB00813" } ], "Morphine": [ { "intervention_type": "DRUG", "description": "morphine", "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" } ], "Remifentanil": [ { "intervention_type": "DRUG", "description": "remifentanil", "name": "Remifentanil", "synonyms": [ "Remifentanil Monohydrochloride", "3-(4-Methoxycarbonyl-4-((1-oxopropyl)phenylamino)-1-piperidine)propanoic Acid Methyl Ester", "GI87084B", "Remifentanyl", "Remifentanil", "GI 87084B", "Remifentanil Hydrochloride", "Ultiva", "Remifentanilo", "GI-87084B" ], "mesh_id": "D000701", "generic_names": [ "Remifentanil" ], "drugbank_id": "DB00899" } ], "Propofol": [ { "intervention_type": "DRUG", "description": "propofol", "name": "Propofol", "synonyms": [ "Propofol MCT", "2,6-Diisopropylphenol", "Propofolum", "ICI-35868", "Fresofol", "2,6-bis(1-methylethyl)phenol", "ICI 35,868", "Ivofol", "Aquafol", "ICI-35,868", "Propofol Rovi", "Propofol Fresenius", "ICI 35868", "ICI35,868", "Disoprofol", "2,6 Diisopropylphenol", "Propofol Abbott", "Diprivan", "ICI35868", "Disoprivan", "Recofol", "Propofol", "Propofol-Lipuro", "2,6-Bis(1-methylethyl)phenol" ], "mesh_id": "D018686", "generic_names": [ "Propofol" ], "drugbank_id": "DB00818", "wikipedia_url": "https://en.wikipedia.org/wiki/Propofol" } ] }

NCT02241473

Hypoxic Training in Obese Patients

https://clinicaltrials.gov/study/NCT02241473

HYPOBESE

UNKNOWN

By analyzing energetic and biomechanical basis of walking, and the subsequent changes induced by hypoxic vs normoxic training in obese individuals, it may optimize the use of walking in hypoxia to gain perspective for exercise prescription to set up training programs that aim to induce negative energy balance and to deal with weight management. However to the investigators knowledge, the analysis of changes in mechanics, energetics and efficiency of walking after continuous hypoxic training (CHT) has not been performed yet. The aims of the present study were: 1. Comparing the changes in body composition between continuous hypoxic training (CHT) and similar training in normoxia; e.g. continuous normoxic training (CNT) in obese subjects. 2. Comparing the metabolic and energetics adaptations to CHT vs CNT. 3. Finally, comparing the associated body-loss induced gait modification since walking intensity at spontaneous walking speed (Ss) is lower in CHT than in CNT.

NO

Obesity

OTHER: Training

Body composition and mass, All subjects will undergo dual-energy X-ray absorptiometry (DEXA) and bio-impedance for measurements of body composition., Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)|Net energy cost of walking, The subjects will be then asked to complete five 6 min level walking trials on the instrumented treadmill at five equally spaced speeds (0.55, 0.83, 1.11, 1.38 and 1.66 m/s), in randomized order. They will be allowed to establish their own preferred stride rate combination for each condition and will be given 5 min of rest between walking trials. During the walking trials, oxygen uptake (V˙O 2), carbon dioxide (CO2) output (V˙C O2) and ventilation (V˙ E) will be measured breath-by-breath (OxyconPro, Jaeger, Germany) and the volume and gases calibrations will be checked before each trial. Oxygen uptake values from the last 2 min will be averaged and normalized to body mass (V˙O 2, mlO2∙kg-1∙min-1). This value minus resting V O2 was then divided by walking speed to obtain the net energy cost of walking (mlO2∙kg-1∙m-1)., Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)|Mechanical external and internal work, During steady metabolic state (i.e., the last 2 min of walking for each speed), the mechanical external (Wext) and internal (Wint) work changes of 20 consecutive walking steps will be determined with an instrumented treadmill (H-P-COSMOS Treadmill MCU2 EPROM 2.31), consisting of a treadmill mounted on four 3-D force sensors, following the methods described in detail by Cavagna (Cavagna 1975) and Willems et al. (1995)., Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)|Efficiency, Total mechanical work and efficiency. The total mass-specific muscular work per distance travelled (Wtot) will be calculated as the sum of Wext and Wint. The mechanical efficiency will be computed as the ratio between Wtot and net energy cost of walking., Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)

Blood samples (this measure is a composite), The blood samples were drawn at rest before (session 1) and after (session 12) the training program during fasting to determine total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides (TG), leptin, total adiponectin, resistin, retinol-binding protein 4 (RBP4), plasma glucose and insulin concentrations (this measure is a composite)., Change from baseline at 5 weeks (e.g., baseline and 5th week after inclusion)

University of Lausanne

CHUV - Centre des Maladies Osseuses - Département de l Appareil Locomoteur (DAL)|Centre Hospitalier Universitaire Vaudois

ALL

ADULT

OTHER

INTERVENTIONAL

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

136/14

2014-09

2015-07

2015-07

2014-09-16

2014-09-16

Institute of Sport Sciences of the University of Lausanne, Lausanne, Vaud, 1015, Switzerland

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

NCT05680727

Individualized Functional Connectivity Targeting in aiTBS for Depression

https://clinicaltrials.gov/study/NCT05680727

AINT

RECRUITING

The goal of this clinical trial is to estimate the importance of neuroimaging in accelerated intermittent theta burst stimulation (aiTBS) for depression. Participants will receive aiTBS treatment, but they will not know if their treatment spot was found with neuroimaging or head measurements.

NO

Depressive Disorder, Major|Depression|Mood Disorders|Mental Disorder|Psychiatric Disorder

PROCEDURE: transcranial magnetic stimulation

Montgomery-Åsberg Depression Rating Scale (MADRS), Depression severity rating scale (0-60, higher numbers indicate higher severity), one month after treatment

Montgomery-Åsberg Depression Rating Scale (MADRS), Depression severity rating scale (0-60, higher numbers indicate higher severity), immediately after treatment ends|Beck Depression Inventory (BDI), Depression severity rating scales (0-63, higher numbers indicate higher severity), immediately after treatment ends and at all subsequent timepoints (1 week, 1 month, 3 months, 6 months, 9 months, 12 months)|Quick Inventory of Depressive Symptomatology (QIDS), Depression severity rating scales (0-27, higher numbers indicate higher severity), immediately after treatment ends and at all subsequent timepoints (1 week, 1 month, 3 months, 6 months, 9 months, 12 months)|Change in resting state functional connectivity in the depression network, blood oxygen level-dependent (BOLD) signal, one month after treatment|Percentage of screened patients from TMS clinical programs who select the accelerated iTBS trial over routine clinical TMS, Patient preference measure, through study completion, an average of 2 years|Temperament and Character Inventory, Revised 140-item, Psychobiologically-based personality inventory which measures seven personality dimensions (harm avoidance, novelty seeking, reward dependence, persistence, self-directedness, cooperativeness, and persistence). For each dimension, this yields a scaled T-score (mean score of 50 with standard deviation of 10). This is an overall estimate of personality traits, and there are no better or worse traits., one month after treatment|Emotional Conflict Resolution Task, Computer task measuring accuracy and reaction time, one month after treatment|Learning, Multi-Source Interference Task (MSIT), Computer task measuring accuracy and reaction time, one month after treatment|Penn Emotion Recognition Task (ER-40), Computer task measuring accuracy and reaction time, one month after treatment|Death Suicide IAT (DSIAT), Computer task measuring reaction time, one month after treatment|Beck Anxiety Inventory (BAI), Anxiety severity rating scale (0-63, higher numbers indicate higher severity), immediately after treatment ends and at all subsequent timepoints (1 week, 1 month, 3 months, 6 months, 9 months, 12 months)

Brigham and Women s Hospital

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

2022p001650

2023-07-15

2026-07-15

2027-01-01

2023-01-11

2023-12-05

Brigham and Women s Hospital, Boston, Massachusetts, 02115, United States

{ "transcranial magnetic stimulation": [ { "intervention_type": "PROCEDURE" } ] }

NCT01098227

Exhaled Nitric Oxide Levels in Infants and Young Children Infected With RSV or Other Viral Infections

https://clinicaltrials.gov/study/NCT01098227

WITHDRAWN

The fraction of exhaled nitric oxide (FeNO) in expired air is a reliable measure of airway inflammation and has been used as a marker in asthma and other respiratory illnesses such as primary ciliary dyskinesia, bronchopulmonary dysplasia (BPD), liver cirrhosis, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF). Although, some exquisite bench research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV, there is a paucity of clinical data regarding levels of feNO in viral respiratory illness and specifically RSV. The investigators conducted a pilot study from the fall of 2007 until October of 2009, looking at FeNO levels in RSV infected patients and compared it to non-RSV viral infections. The investigators recruited a total of 28 RSV positive and 1 RSV negative subjects, as well as 4 control subjects. The investigators found FeNO values not statistically significant between the study group (the two-tailed p=0.09, considered not quite significant), but there was a trend of higher FeNO values in the non-RSV group when compared to the RSV group. A larger sample may detect a statistically significance between these 2 groups. Objectives: i. To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness when compared with normal subjects without respiratory symptoms. ii. To determine if there is a difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness. Method of feNO measurement utilized the offline options for preschool children & infants appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society & the European Respiratory Society when discussing tidal breathing techniques with uncontrolled flow rate. The investigators plan that our sample sizes for the RSV+ and control groups will be, by design, three times as large as the RSV- group. In order to achieve 80% power, the investigators will then require 45 control and 45 RSV+ patients, and 15 RSV- patients

NO

Bronchiolitis|Infection|Nitric Oxide

To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness when compared with normal subjects without respiratory symptoms, 1 year|To determine if there is a difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness, 1 year

NYU Langone Health

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

147914

2010-01

2011-06

2011-06

2010-04-02

2020-03-16

Winthrop University Hospital, Mineola, New York, 11501, United States

{}

NCT03340727

Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial

https://clinicaltrials.gov/study/NCT03340727

MoCHA

ACTIVE_NOT_RECRUITING

The objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

NO

Apnea of Prematurity

DRUG: Caffeine Citrate|DRUG: Placebo

Number of days of hospitalization, The number of days of hospitalization from randomization to discharge up to 48 weeks postmentrual age (PMA), with censoring at time of transfer or death., Randomization until discharge up to 48 wks PMA

The number of days to physiologic maturity after randomization, Physiologic maturity is defined as: 1) Temperature: out of the incubator for at least 48 hours with normal body temperature, 2) Feeding: oral feeding at a volume of at least 140 ml/kg/day or growing on less than 140 ml/kg/day for at least 48 hours and 3) Respiratory: apnea-free for at least 5 days. The number of days to physiologic maturity after randomization up to 48 wks PMA, with censoring at time of transfer or death., Randomization until physiologic maturity up to 48 wks PMA|PMA at discharge, Post menstrual age at discharge up to 48 wks PMA, censoring at time of transfer or death., Randomization until discharge up to 48 wks PMA|The number of all-cause hospital re-admissions, The number of all-cause re-admissions to the hospital within the first four weeks, second four weeks, and first eight weeks combined among those discharged from the hospital by 48 wks PMA., Discharge until eight weeks after discharge up to 52 wks PMA|The number of all-cause sick visits, The number of all-cause sick visits to urgent care, emergency rooms, or health care provider s office within the first four weeks, second four weeks, and first eight weeks combined among those discharged from the hospital by 48 wks PMA., Discharge until eight weeks after discharge up to 52 wks PMA|Death, All cause mortalities, Randomization until eight weeks after discharge up to 52 wks PMA|Weight, Weight will be recorded at time of of birth, randomization and at status: discharge up to 48 wks PMA ,with censoring at time of transfer or death, Randomization until discharge up to 48 wks PMA|Elevated Heart Rate, The number of days after randomization that infant had at least two consecutive heart rates >200 documented at least 3 hours apart (when infant not crying) until discharge up to 48 wks PMA, with censoring at time of transfer or death, Randomization until discharge up to 48 wks PMA|High Blood Pressure, Treatment for high blood pressure initiated after randomization until discharge up to 48 wks PMA, with censoring at time of transfer or death, Randomization until discharge up to 48 wks PMA|Periods of NPO, The number of episodes between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death) that infant was placed NPO for ≥ 24 hours., Randomization until discharge up to 48 wks PMA|Reflux, The use of anti-reflux medications started between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death), Randomization until discharge up to 48 wks PMA|Significant Apnea, The number of days that significant apnea, as defined by receiving open label caffeine, CPAP for apnea or ventilatory support for apnea, is documented between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death), Randomization until discharge up to 48 wks PMA|Significant Bradycardia, The number of days that significant bradycardia, as defined by receiving treatment, is documented between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death), Randomization until discharge up to 48 wks PMA|Arrhythmia, The presence of documented and treated arrhythmias between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death), not due to tachycardia or bradycardia, Randomization until discharge up to 48 wks PMA|Seizures, The onset of documented seizures, as defined by treating with anti-convulsants, between randomization and status (discharge up to 48 wks PMA, with censoring at time of transfer or death)., Randomization until discharge up to 48 wks PMA

NICHD Neonatal Research Network

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ALL

CHILD

PHASE3

NETWORK

INTERVENTIONAL

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

NICHD-NRN-0056|UG1HD034216|UG1HD027904|UG1HD021364|UG1HD027853|UG1HD040689|UG1HD040492|UG1HD027851|UG1HD087229|UG1HD053109|UG1HD068278|UG1HD068244|UG1HD068263|UG1HD027880|UG1HD053089|UG1HD087226|U10HD036790

2019-02-27

2023-03

2023-03

2017-11-13

2023-02-10

University of Alabama at Birmingham, Birmingham, Alabama, 35233, United States|Stanford University, Palo Alto, California, 94304, United States|Emory University, Atlanta, Georgia, 30303, United States|University of Iowa, Iowa City, Iowa, 52242, United States|University of New Mexico, Albuquerque, New Mexico, 87131, United States|University of Rochester, Rochester, New York, 14642, United States|RTI International, Durham, North Carolina, 27705, United States|Duke University, Durham, North Carolina, 27710, United States|Cincinnati Children s Medical Center, Cincinnati, Ohio, 45267, United States|Case Western Reserve University, Rainbow Babies and Children s Hospital, Cleveland, Ohio, 44106, United States|Research Institute at Nationwide Children s Hospital, Columbus, Ohio, 43205, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Brown University, Women & Infants Hospital of Rhode Island, Providence, Rhode Island, 02905, United States|University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75235, United States|University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States|University of Utah, Salt Lake City, Utah, 84108, United States

{ "Caffeine Citrate": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT03235973

Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes

https://clinicaltrials.gov/study/NCT03235973

CEREAL

UNKNOWN

The investigators focused on patients with refractory acute leukemia or MDS and designed a phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided myeloablative busulfan doses. This scheme allows combining different optimization of RTC experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine analog cladribine) to approach a specific platform to treat refractory diseases.

NO

Leukemia, Myeloid, Acute|Leukemia, Lymphoblastic, Acute

DRUG: Fludarabine-Cladribine-Busulfan conditioning regimen

estimation of the maximal tolerable dose,if any,and recommended phase II dose of cladribine administered as in combination with fludarabine and PK-guided IV busulfan prior Allo-HSCT for refractory acute leukemia and myelodysplastic syndrome (MDS), Occurrence ratio of dose-limiting toxicity defined as any grade ≥ 3 toxicity according to CTCAE (version 4.03 ) attributable to conditioning regimen (extra-medullary toxicity), considered to be related or probably related to the Cla-Fu-Bu RTC by the investigator., 30 days after Allo-HSCT

Cumulative incidence of acute Graft versus host disease, Cumulative incidence of acute Graft versus host disease according to Gluckberg s classification, 100 days|Cumulative incidence of chronic Graft versus host disease, Cumulative incidence of chronic Graft versus host disease according to NIH classification, 1 year|Cumulative incidence of relapse, Cumulative incidence of relapse at 1 year, 1 year|Cumulative incidence of Non Relapse Mortality, Cumulative incidence of Non Relapse Mortality at day +100 and 1 year after Allo-HSCT, 100 days, 1 year

Institut Paoli-Calmettes

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

CEREAL-IPC 2016-010

2018-04-28

2020-04

2021-04

2017-08-01

2018-06-28

Institut Paoli-Calmettes, Marseille, Bouches-du-Rhône, 13009, France

{ "Fludarabine-Cladribine-Busulfan conditioning regimen": [ { "intervention_type": "DRUG" } ] }

NCT02337673

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography

https://clinicaltrials.gov/study/NCT02337673

COMPLETED

The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.

NO

Pulmonary Disease|Postoperative Respiratory Complications|Malignant Neoplasm of Stomach|Liver Diseases|Pancreatic Diseases

Change of regional ventilation partition (ROI analysis in 8 pulmonary ROIs) from preoperative to postoperative state., Comparison of the changed regional ventilation partition to the occurence of postoperative pulmonary complications => calculation of sensitivity and specifity of the primary outcome measure to predict PPC. Statistical analysis: receiver operating characteristic (ROC curve)., 1.) First EIT-measure: Preoperative Day; 2.) Second EIT-measure: Day of Operation (after extubation) or in between Postoperative Day 1-7 (in case of deferred extubation)

Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs), Sensitivity and specifiy for appearance of PPC (Postoperative Pulmonary Complications) within Postoperative Day 1-7. Statistical analysis: Sensitivity, Specificity, ROC-curve, 1 week|Postoperative EIT-measured regional ventilation distribution (ROI analysis in 8 pulmonary ROIs), Correlation of pre-existing pathologic pulmonary conditions with specific postoperative changes in regional distribution of lung ventilation and perfusion assessed by EIT Statistical analysis: Sensitivity, Specificity, ROC-curve, 1 week|Appearance of all specific forms of PPC (Postoperative Pulmonary Complications) within postoperative day 1-7, Appearance of all different forms of PPC within Postoperative Day 1-7 and relation to postoperative EIT-measure (ROI analysis in 8 pulmonary ROIs). Statistical analysis: Sensitivity, Specificity, ROC-curve, 1 week|Outcome (e.g. mortality, time of intensive care therapy, ventilator-obligatory-free days on Postoperative Day 1-7 Postoperative EIT-measure is predictive for patients outcome, Sensitivity and specifity of postoperative EIT-measure for mortality. Statistical analysis: Sensitivity, Specificity, ROC-curve, 1 week|Time of intensive care therapy, Sensitivity and specifity of postoperative EIT-measure for time of intensive care therapy. Statistical analysis: Sensitivity, Specificity, ROC-curve, 1 week|Ventilator-obligatory-free days, Sensitivity and specifity of postoperative EIT-measure for Ventilator-obligatory-free days. Statistical analysis: Sensitivity, Specificity, ROC-curve, 1 week

Johannes Gutenberg University Mainz

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

JohannesGU-EIT-01

2014-05

2016-03

2016-03

2015-01-14

2023-09-29

Universitätsmedizin Mainz, Klinik für Anästhesiologie (University Hospital of Johannes Gutenberg-University Mainz, Department of Anesthesiology), Mainz, Rheinland-Pfalz (Rhineland-Palatinate), 55110, Germany

{}

NCT00000473

Do Fish Oils Prevent Restenosis Post-Coronary Angioplasty?

https://clinicaltrials.gov/study/NCT00000473

COMPLETED

To determine whether a dietary supplement of n-3 polyunsaturated fatty acids (PUFAs) derived from fish oil would decrease the restenosis rate in patients undergoing percutaneous transluminal coronary angioplasty (PTCA).

NO

Cardiovascular Diseases|Coronary Disease|Heart Diseases|Myocardial Ischemia

BEHAVIORAL: dietary supplements|DRUG: fatty acids, omega-3|BEHAVIORAL: diet, fat-restricted

National Heart, Lung, and Blood Institute (NHLBI)

ALL

ADULT, OLDER_ADULT

PHASE3

NIH

INTERVENTIONAL

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

62|U01HL040548-04

1989-07

1994-06

1999-10-28

2013-12-13

{ "dietary supplements": [ { "intervention_type": "BEHAVIORAL" } ], "Omega-3 fatty acids": [ { "intervention_type": "DRUG", "description": "fatty acids, omega-3", "name": "Omega-3 fatty acids", "synonyms": [ "Omega 3 fatty acids", "Omega-3 fatty acid", "Omega-3 acid triglycerides", "\u03c9-3 fatty acids", "Omega-3 (n-3) polyunsaturated fatty acids", "Omega-3 fatty acids", "Omega-3", "Phospholipids", "Omega-3-acid triglycerides", "Omega-3 polyunsaturates", "Omega-3 phospholipids", "n-3 fatty acids", "Omega-3 polyunsaturated fatty acids", "Omega-3 acid" ], "drugbank_id": "DB11133", "generic_names": [ "Omega-3 fatty acids" ] } ], "diet, fat-restricted": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05302973

Aerobic Exercise in People With Post-COVID-19

https://clinicaltrials.gov/study/NCT05302973

COMPLETED

The primary aim of this study is to study the feasibility of an aerobic training, in addition to conventional rehabilitation, in patients post sequela of interstitial pneumonia due to COVID-19. In particular, we wish to verify if patients could tolerate this kind of physical activity and if there are any adverse effects. The secondary aim is to evaluate if the aerobic exercise is effective in improving functional capacity and gait performance in these patients respect to the common physiotherapy.

NO

COVID-19

OTHER: Conventional rehabilitation|OTHER: Aerobic exercise

Analysis of feasibility, To assess the feasibility, it will be evaluated the adherence to treatment of participants enrolled in the aerobic exercise group. It will be expressed both as compliance rates, defined in terms of duration (% sessions performed reaching the goal of 30min) and prescribed intensity (% sessions performed at an intensity between 64-76% HRmax)., Up to 2 weeks

Timed Up and Go (TUG) test, TUG is a physical functional measure in which subjects are asked to stand up from a chair, walk 3 m to a horizontal line marked with tape on the floor, turn around, walk back and sit down at a comfortable pace (Podsiadlo and Richardson, 1991). Time in seconds necessary for perform the test will be collected., Up to 2 weeks|Muscle torque of knee extensors, The muscle torque of the knee extensors will be evaluated pre- and post-training with the use of a handheld dynamometer. The patient will be required to perform a sub-maximal contraction in knee extension, followed by two maximal contractions during which the physiotherapist will give verbal encouragement. The evaluation will be performed first on one limb, then on the other, with a 30-second pause between one contraction and the next. The mean value of the two right- leg and left-leg tests will be recorded. Measurements will be converted from kilo to newton., Up to 2 weeks|Handgrip strength, The handgrip strength will be measured bilaterally with a calibrated Jamar dynamometer. In accordance with the recommendations of the American Society of Hand Therapist, subjects will be seated with feet flat on the floor, the tested arm adducted against the body in neutral rotation, the elbow in 90° of flexion, and the forearm in neutral rotation pronation/supination (Fess and Moran, 1981). Two trials for each arm will be performed; the average of the right and left force will be recorded by the tester in kilo and then converted to newtons., Up to 2 weeks|1-minute sit-to-stand test (1STST), The 1STST is a widely implementable measure of lower body muscular strength and endurance (Bohannon, 1995) which capture the number of stands a person can complete in 1 minute without using the arms. Patients will be asked to perform repetitions of standing upright and then sitting down in the same position at a self-paced speed (safe and comfortable) as many times as possible for 1 min, without using the arms and fully sitting between each stand. The number of completed stands will be recorded. SpO2 before and after the test will be recorded., Up to 2 weeks|Cumulated Ambulation Score - Italian version (CAS-I), The CAS-I is a 3-item scale assessing activities that characterize the patient s basic mobility skills: 1) getting in and out of bed, 2) sit-to-stand from a chair with armrests and 3) walking indoors with the use of appropriate walking aids. Each activity is assessed on a three-point ordinal scale from 0-2 (0 = Not able to, despite human assistance and verbal cueing, 1 = Able to, with human assistance and/or verbal cueing from one or more persons, 2 = Able to safely, without human assistance or verbal cueing, use of a walking aid allowed) resulting in a total daily CAS score ranging from zero to six., Up to 2 weeks|Functional Independence Measure (FIM), This scale is a widely used tool for rating the rates patients ADL performances. It is composed by 18 items, that is 13 motor and 5 cognitive items, each of whom is assigned a score between 7 (total independence) and 0 (total dependence). Therefore, the total FIM scores range between 18 (reflecting complete functional dependency) and 126 (reflecting complete functional independency)., Up to 2 weeks|Physical Activity Scale for the Elderly (PASE), It is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiologic studies of persons age 65 years and older. The PASE score combines information on leisure, household, and occupational activity (Washburn et al., 1993)., Up to 100 days

Istituti Clinici Scientifici Maugeri SpA

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2592 CE

2021-11-22

2022-12-31

2023-07-10

2022-03-31

2023-07-21

Istituti Clinici Scientifici Maugeri, Veruno, Novara, 28010, Italy

{ "Conventional rehabilitation": [ { "intervention_type": "OTHER" } ], "Aerobic exercise": [ { "intervention_type": "OTHER" } ] }

NCT06127173

Effect of PEEP on Gastric Insufflation During Face Mask Induction of General Anesthesia in Children

https://clinicaltrials.gov/study/NCT06127173

RECRUITING

The aim of our study is first to assess the effect of different PEEP levels on gastric volume using ultrasonography during induction of general anesthesia in children undergoing elective surgery

NO

Anesthesia|Child

OTHER: Positive End Expiratory Pressure PEEP

Gastric residual volume immediately after intubation, ultrasound guided measurement of gastric residual volume immediately after intubation, 15 minutes

Lung Ultrasound Score, Each lung will be divided into 3 areas. For each area, a score of 0 to 3 has been assigned. Scores as follows, for any lung area: 0 indicates A-pattern (defined by the presence of only A-lines); 1, B-pattern (defined as the presence of 3 B-lines, well-spaced); 2, severe B-pattern (defined as the presence of crowded and coalescent B lines with or without consolidations limited to subpleural space); and 3, extended consolidation., 15 minutes|Qualitative gastric antrum score, * Grade 0 antrum: is defined as the absence of fluid content in both supine and RLD positions. * Grade 1 antrum: If fluid content is observed only in the RLD position, but not in the supine position. * Grade 2 antrum: If fluid is observed in both supine and RLD., 15 minutes

Kasr El Aini Hospital

Fayoum University

ALL

CHILD

OTHER

INTERVENTIONAL

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

D 343

2023-10-10

2024-12-01

2024-12-01

2023-11-13

2023-11-13

Cairo university hospitals, kasralainy, Cairo, 11559, Egypt

{ "Positive End Expiratory Pressure PEEP": [ { "intervention_type": "OTHER" } ] }

NCT05705973

Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients

https://clinicaltrials.gov/study/NCT05705973

NAGOMI COMPLEX

RECRUITING

The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI subjects. The features for a complex PCI are based upon subgroup analysis of earlier published studies.

NO

Cardiovascular Disease|Coronary Artery Occlusion|Ischemic Heart Disease

DEVICE: Ultimaster Nagomi™

Target Lesion Failure (TLF), Defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization., at 1-year post procedure

Delivery success, Delivery success is defined as an achievement of successful delivery of study stent to the target lesion, expansion of the study stent and withdrawal of the delivery catheter., Intraoperative|Lesion success, Lesion success is defined as the attainment of < 30% residual stenosis by visual estimate and/or < 50% (by QCA) using any percutaneous method (if QCA was not available, the visual estimate of diameter stenosis is used)., Intraoperative|Device success, Device Success is defined as delivery success with the achievement of a final residual diameter stenosis of the target lesion of < 30% by visual assessment and/or < 50% by QCA, using the assigned device only., Intraoperative|Procedure success, Procedure Success is defined as the achievement of < 30% residual stenosis by visual assessment in all target lesions using any percutaneous method without the occurrence of death, Q wave or WHO defined non-Q wave, or repeat revascularization of the target lesion during the hospital stay., during hospitalization, approximately 3 days|Target lesion failure (TLF), The composite of cardiovascular death, MI (not clearly attributable to a nontarget vessel) and clinically driven Target lesion revascularization (TLR)., at index procedure, 30 days, 6 months, 1 year, and 2 years|Patient oriented composite endpoint (POCE), Defined as composite of all-cause mortality, any MI and any coronary revascularization., at index procedure, 30 days, 6 months, 1 year, and 2 years|Death and subclassifications, Death may be subclassified as: Cardiovascular death, Noncardiovascular death or Undetermined death. Cardiovascular death may include death caused by acute MI, death caused by sudden cardiac death, including unwitnessed, death resulting from heart failure, death caused by stroke, death caused by cardiovascular procedures, death resulting from cardiovascular hemorrhage, death resulting from other cardiovascular cause. Noncardiovascular death may include death from malignancy, death resulting from pulmonary causes, death caused by infection (including sepsis), death resulting from gastrointestinal causes, death resulting from accident/trauma, death caused by other noncardiovascular organ failure, death resulting from other. Undetermined cause of death is defined as a death not attributable to any other category because of the absence of any relevant source documents., at index procedure, 30 days, 6 months, 1 year, and 2 years|Myocardial infarction and subclassifications, Myocardial infarction - Absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit, plus 1 (or more) of the following criteria: * New significant* Q waves or equivalent * Flow-limiting angiographic complications * New substantial loss of myocardium on imaging * Q-wave criteria requires the development of new Q waves ≥40 ms in duration and ≥1 mm deep in voltage in ≥2 contiguous leads., at index procedure, 30 days, 6 months, 1 year, and 2 years|Revascularization and subclassifications, Successful revascularization of all lesions with angiographically a diameter stenosis ≥ 50%, at index procedure, 30 days, 6 months, 1 year, and 2 years|Stent thrombosis (ST) and subclassifications, Definite ST Presence of a thrombus that originates in the stent/scaffold or in the segment 5mm prox. or dist. to the stent/scaffold or in a side branch originating from the stented/scaffolded segment & at least 1 of the ff: Acute onset of ischemic symptoms at rest New ECG changes suggestive of acute ischemia Typical rise and fall in cardiac biomarkers Or Pathological confirmation of thrombosis Evidence of recent thrombus within the stent/scaffold determined at autopsy Examination of tissue retrieved ff. thrombectomy Probable ST Any MI that is related to documented acute ischemia in the territory of the implanted stent/scaffold w/out angiographic confirmation of stent/scaffold thrombosis and in the absence of any other obvious cause. Occlusive thrombus Thrombolysis in MI grade 0/1 flow w/in or prox. to a stent/scaffold segment. Nonocclusive thrombus Intracoronary thrombus defined as a noncalcified filling defect or lucency surrounded by contrast material seen in mu, at index procedure, 30 days, 6 months, 1 year, and 2 years|Bleeding (Bleeding Academic Research Consortium (BARC) 3-5), Type 3:Clinical, lab, and/or imaging evidence of bleeding w/ specific healthcare provider responses, as below: Type 3a Any BT with overt bleeding Overt bleeding plus Hgb drop ≥3 to < 5 g/dL Type 3b Overt bleeding plus Hgb drop ≥5 g/dL Cardiac tamponade Bleeding requiring surgical intervention for control Bleeding requiring IV vasoactive drugs Type 3c Intracranial hemorrhage Type 4:CABG-related bleeding Perioperative intracranial bleeding w/in 48 hr Reoperation after closure of sternotomy for bleeding control Transfusion of ≥5 U whole blood or packed RBC w/in a 48-hr period Chest tube output ≥2 L w/in a 24-hr period Type 5:Fatal bleeding Bleeding that directly causes death with no other explainable cause. Categorized as: Type 5a Probable bleeding that is clinically suspicious as the cause of death, but bleeding is not directly observed and no autopsy or confirmatory imaging. Type 5b Definite bleeding that is directly observed (clinical specimen or imaging), at index procedure, 30 days, 6 months, 1 year, and 2 years|Balance between bleeding (BARC 3-5) and thrombotic event (myocardial infarction and/or stent thrombosis), The number of patients with a BARC 3-5 bleeding in comparison to the number of patients with a myocardial infarction and/or a stent thrombosis., at index procedure, 30 days, 6 months, 1 year, and 2 years|Utilization of cardiovascular health care resources, Number of devices used during the procedure and use of anti-platelet and anti-thrombotic medication during the follow-up period., at index procedure, 30 days, 6 months, 1 year, and 2 years|Quality of Life assessment, Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire: The first part of the questionnaire contain descriptive questions on 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression, each with 5 levels of responses. The second part of the questionnaire contains a standard vertical 20-cm visual analog scale that is calibrated from the worst health you can imagine (scored 0) at its base to the best health you can imagine (scored 100) at its apex., at baseline, 30 days, 6 months, 1 year, and 2 years|Angina status assessment Seattle Angina Questionnaire (SAQ), Angina status will be assessed through the Seattle Angina Questionnaire (SAQ). The SAQ is a validated disease-specific instrument for assessing the health status of patients with coronary artery disease. Scoring: Scores range from 1-100 with higher scores indicating better health, at baseline, 30 days, 6 months, 1 year, and 2 years|QCA of the index procedure angiogram for a subset of patients with a Complex Bifurcation Lesion (CBL), Luminal dimensions of bifurcation lesions will be measured by off-line quantitative coronary angiography by a central core laboratory. The objective of the QCA is to quantitate and express the benefit of the Proximal Optimisation Technique (POT). The POT balloon positioning is of importance in this technique as well as the balloon diameter to obtain optimal stent apposition in the main branch., procedure

Terumo Europe N.V.

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

T137E4

2023-04-25

2026-09

2027-09

2023-01-31

2024-01-24

Imelda Hospital, Bonheiden, Belgium|C.H.U. Charleroi, Charleroi, Belgium|Ziekenhuis Oost-Limburg, Genk, Belgium|CHR Citadelle, Liège, Belgium|Clinique Saint-Luc Bouge, Namur, Belgium|CHU UCL Mont Godinne Namur, Yvoir, Belgium|East Tallinn Central Hospital, Tallin, Estonia|Mater Private Network, Cork, Ireland|Mater Private Hospital, Dublin, Ireland|IRCCS Istituto Auxologico Italiano, Milano, Italy|Rijnstate Ziekenhuis, Arnhem, Netherlands|Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands|Catharina Hospital Eindhoven, Eindhoven, Netherlands|Medisch Centrum Leeuwarden, Leeuwarden, Netherlands|Maasstad Ziekenhuis, Rotterdam, Netherlands|Jeroen Bosch Ziekenhuis, s-Hertogenbosch, Netherlands|Hospital de la Santa Creu i Sant Pau, Barcelona, Spain|Hospital Universitario Juan Ramón Jiménez, Huelva, Spain|Salamanca University Hospital, Salamanca, Spain|Hospital Universitario Virgen del Rocio, Sevilla, Spain|Universitätsspital Basel, Basel, Switzerland|Istituto Cardiocentro Ticino, Lugano, Switzerland|Royal Sussex County Hospital, Brighton, United Kingdom|Lincolnshire Heart Centre Lincoln County Hospital, Lincoln, United Kingdom|Newcastle Freeman Hospital, Newcastle upon Tyne, United Kingdom|University Hospital Plymouth NHS trust, Plymouth, United Kingdom|University Hospital of North Midlands, Staffordshire, United Kingdom|Worcestershire Royal Hospital, Worcester, United Kingdom

{ "Ultimaster Nagomi\u2122": [ { "intervention_type": "DEVICE" } ] }

NCT06368973

Mechanical Ventilation-Associated Complications and Co-Morbidities in Children Admitted in Pediatric Intensive Care Unit

https://clinicaltrials.gov/study/NCT06368973

COMPLETED

The goal of this study was to identify the prevalence of mechanical ventilation-associated complications and co-morbidities in pediatric patients admitted to the PICU of Benha University Hospital, uncover how often these problems occur, their types, factors linked to them and to compare the epidemiology of MV-associated complications.

NO

Mechanical Ventilation Complication

Adverse events associated with mechanical ventilation, to assess incidence of complications associated with invasive ventilation in critically ill children, 4 weeks after following usage of invasive mechanical ventilation

Benha University

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RC16-4-2023

2021-01-01

2023-12-01

2023-12-31

2024-04-16

2024-04-16

Benha University Hospital, Cairo, 13511, Egypt

{}

NCT00799773

Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)

https://clinicaltrials.gov/study/NCT00799773

STAR

TERMINATED

Thrombotic thrombocytopenic purpura (TTP) is a rare disorder that causes blood clots to form in blood vessels. The main treatment for TTP is plasma exchange, in which affected patients receive transfusions of plasma, the liquid part of blood, from healthy donors. This study will examine the effectiveness of an antibody, rituximab, in combination with plasma exchange, at improving the immune response in people with TTP and decreasing the recurrence of TTP.

YES

Thrombotic Thrombocytopenic Purpura

DRUG: Rituximab|PROCEDURE: Plasma exchange|DRUG: Corticosteroids

Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids, Measured at Day 52

Use of Non-study Treatment, Measured at Month 36|Whether Participants Receiving Rituximab Achieve Early or Late Treatment Response Faster and Require Fewer Plasma Exchanges Than Participants Not Receiving Rituximab, Measured at Days 52 and 82|Relationship Between Clinical and Laboratory Data and Response to Treatment, Measured at Days 52 and 82|Incidence of Relapse Among Participants in the Two Study Groups Who Achieve Early Treatment Response, Measured at Month 36|All Cause Mortality, Measured at Month 36|Treatment-related Complications, Measured at Day 52|Evaluating How Levels of ADAMTS-13 Enzyme and Autoantibody at Specific Time Points or Over the Course of the Study Correlate With Other Indicators of Disease Activity, Remission Rates, Rapidity of Achieving a Remission, and Recurrence Rate, Measured at Month 36|Rituximab Response in Participants With Varying Levels of ADAMTS-13 Activity and Antibodies Against ADAMTS-13, Measured at Month 36|Effect of Plasma Exchange on Rituximab Levels, Measured at Month 6|Effect of Rituximab Levels on the Extent of B-cell Depletion (CD-19+ Cells), Measured at Month 12|B-cell Depletion in Relation to ADAMTS-13 Activity and to ADAMTS-13 Antibody Levels and Disease Activity in Participants Who Receive Rituximab Versus Those Who do Not, Measured at Month 12

Carelon Research

National Heart, Lung, and Blood Institute (NHLBI)|Genentech, Inc.

ALL

CHILD, ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

558|U01HL072268|HL072268|HL072033|HL072291|HL072196|HL072248|HL072191|HL072305|HL072028|HL072072|HL072355|HL072283|HL072346|HL072331|HL072290

2009-04

2010-02

2010-02

2008-12-01

2013-07-22

2013-07-22

University of Alabama, Birmingham, Birmingham, Alabama, 35249, United States|Emory University, Atlanta, Georgia, 30322, United States|University of Iowa, Iowa City, Iowa, 52242, United States|Tulane University Health Sciences Center, New Orleans, Louisiana, 70112, United States|University of Maryland Medical Center, Baltimore, Maryland, 21201, United States|Johns Hopkins Hospital, Baltimore, Maryland, 21205, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115, United States|Brigham and Women s Hospital, Boston, Massachusetts, 02115, United States|Children s Hospital Boston, Boston, Massachusetts, 02115, United States|New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, 10021, United States|University of North Carolina Hospitals, Chapel Hill, North Carolina, 27514, United States|Duke University Medical Center, Durham, North Carolina, 27710, United States|University Hospital Cleveland, Cleveland, Ohio, 44106, United States|University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, 73104, United States|Integris Baptist Medical Center, Oklahoma City, Oklahoma, 73112, United States|University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Children s Hospital of Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States|University of Pittsburgh Presbyterian and Shadyside Hospital, Pittsburgh, Pennsylvania, 15213, United States|Puget Sound Blood Center, Seattle, Washington, 98104, United States|Gunderson Clinic, LTD, LaCrosse, Wisconsin, 54601, United States|University of Wisconsin at Madison, Madison, Wisconsin, 53792, United States|Froedtert Memorial Lutheran Hospital, Milwaukee, Wisconsin, 53226, United States

{ "Rituximab": [ { "intervention_type": "DRUG", "description": "Rituximab", "name": "Rituximab", "synonyms": [ "Mabthera", "rituximab-abbs", "MabThera", "Rituximab CD20 Antibody", "IDEC C2B8", "Rituximab", "GP2013", "Truxima", "rituximab-arrx", "IDEC-C2B8", "IDEC-C2B8 Antibody", "Rituxan", "CD20 Antibody, Rituximab", "rituximab-pvvr", "IDEC C2B8 Antibody" ], "medline_plus_id": "a607038", "generic_names": [ "Rituximab" ], "mesh_id": "D000074322", "drugbank_id": "DB00073", "wikipedia_url": "https://en.wikipedia.org/wiki/Rituximab" } ], "Plasma exchange": [ { "intervention_type": "PROCEDURE" } ], "Corticosteroids": [ { "intervention_type": "DRUG" } ] }

NCT05384873

Immunonutrition for Improving the Efficacy of Immunotherapy in Patients With Metastatic Non-small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT05384873

MURAL

RECRUITING

The present study was designed to evaluate the efficacy of the early systematic provision of oral nutritional supplements enriched in immunonutrients in non-small lung cancer patients undergoing immunotherapy and receiving nutritional counseling

NO

Lung Cancer, Nonsmall Cell

DIETARY_SUPPLEMENT: Immunonutrition|OTHER: Control dietary intervention

Progression-Free Survival (PFS), A progression-free survival rate at 12 months will be calculated, with patients categorized in a dichotomous manner as alive and progression-free or in progression or dead at 12 months., 12 months

Duration of response, Time to progression, 24 months|Overall survival, Overall survival, 24 months|Treatment-related moderate-severe adverse events as assessed by Common Terminology Criteria for Adverse Events [CTCAE v5.0], Difference in the incidence of grade >=3 toxicity, according to CTCAE v5.0, 4 months|Skeletal muscle mass, Change in skeletal muscle mass during the study evaluated with bioimpedance vectorial analysis and computed tomography scans, 12 months|Fatigue, Change in fatigue during the study as assessed by the Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) questionnaire, 12 months|Self-perceived quality of life, Change in quality of life during the study as assessed by validated questionnaires, 12 months|Self-reported physical activity level, Change in self-reported physical activity level as assessed by the Godin s Shepard Leisure Time Exercise Questionnaire, 12 months

Serum levels of immunologic markers, Change in levels of soluble effectors and immuno-regulatory cells during the study by cytofluorimetry and validated biochemical assays, 12 months

IRCCS Policlinico S. Matteo

San Luigi Gonzaga Hospital|Azienda Ospedaliera Universitaria Integrata Verona|Humanitas Hospital, Italy

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

0020364/22

2023-06-01

2025-07-31

2026-07-31

2022-05-20

2023-11-22

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

{ "Immunonutrition": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Control dietary intervention": [ { "intervention_type": "OTHER" } ] }

NCT04743973

A Study to Asses Wellness Using a Brain Sensing Device on Physicians

https://clinicaltrials.gov/study/NCT04743973

ACTIVE_NOT_RECRUITING

A study to asses the feasibility of physicians using a wearable brain sensing wellness device during a time of increased work load, patient volume and stressors to assess the association between duration of active state and calm state as measured by the wearable brain sensing wellness device, and quality of life (QOL), subjective stress, sleep and resilience.

NO

Stress, Emotional|Sleep|Quality of Life

DEVICE: Muse S™ Headband system

Frequency adherence to intervention, Summarizing frequency subjects use intervention during active study participation, 3 months|Duration adherence to intervention, Summarizing duration of time subjects use intervention during active study participation, 3 months

Mayo Clinic

InteraXon, Inc.|Cambridge Brain Sciences

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

20-007207

2021-08-15

2024-10-01

2024-10-01

2021-02-08

2023-12-12

Mayo Clinic in Rochester, Rochester, Minnesota, 55905, United States

{ "Muse S\u2122 Headband system": [ { "intervention_type": "DEVICE" } ] }

NCT04480073

Guided Bone Regeneration With Customized Titanium Meshes

https://clinicaltrials.gov/study/NCT04480073

UNKNOWN

The aims of this prospective clinical study are to evaluate: a) the effectiveness of digitally customized titanium meshes in association with autologous bone particles and bovine bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone regeneration from a histomorphometric point of view

NO

Bone Resorption

PROCEDURE: Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges

Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels, Samples will be processed following a standardized protocol for hard tissues. Bone remodeling and mineralization levels of the new bone matrix (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view, 6-9 months|Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions, Samples will be processed following a standardized protocol for hard tissues. Volumetric tissue fractions (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view, 6-9 months|Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization, Samples will be processed following a standardized protocol for hard tissues. Neo-vascularization (expressed in percentage out of the total volume of analyzed sample in cubic mm) will be analyzed from an histologic point of view, 6-9 months|Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure, Complication rate of the reconstructive procedure (expressed in percentage and number of patients out of the total) will be analyzed, 6-9 months|Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain, Assessment of bone gain obtained before implant placement (expressed in mm) will be analyzed, 6-9 months|Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival, Implant survival (expressed in percentage) will be analyzed, 12 months|Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications, Incidence of implant-related complications 1 year after the starting of prosthetic loading (expressed in percentage) will be analyzed, 12 months|Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption, Peri-implant bone resorption (MBL) after 1 year from the prosthetic load (expressed in mm) will be analyzed, 6-9 months

University of Milan

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

MChiapasco

2018-01-10

2021-12-30

2022-12-30

2020-07-21

2020-07-21

ASST Santi Paolo e Carlo, Milan, 20142, Italy

{ "Customized CAD-CAM Titanium Mesh (Y-xoss CBR\u00ae by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges": [ { "intervention_type": "PROCEDURE" } ] }

NCT03156673

Treatment of COPD by Autologous Transplantation of Bronchial Basal Cells

https://clinicaltrials.gov/study/NCT03156673

UNKNOWN

Bronchial basal cells are proved to be able to regenerate lung structures to repair the injured lung. In COPD patients, bronchus structures are injured and cannot be repaired, which may result in the failure of pulmonary function rescue clinically.In our research, autologous bronchial basal cells will be transplanted into lung of patients suffered with COPD to treat the disease. Specifically, autologous bronchial basal cells will be dissected from brushed-off samples by bronchofiberscope. Then, they will be expanded in vitro and transplanted into lung to regenerate new alveoli and bronchus structures and re-establish pulmonary system.

NO

Chronic Obstructive Pulmonary Disease

BIOLOGICAL: bronchial basal cells

Forced expiratory volume in one second (FEV1), An indicator for pulmonary function test to assess airway obstruction, 1-6 months|Forced vital capacity (FVC), An indicator for pulmonary function test to indicate the maximum amount of air a person can expel from the lungs after a maximum inhalation, 1-6 months

Diffusion capacity of CO (DLCO), An indicator for pulmonary function test to show the extent to which oxygen passes from the air sacs of the lungs into the blood, 1-6 months|The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC), An indicator in pulmonary function test to represent the proportion of a person s vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity, 1-6 months|Maximum mid-expiratory flow (MMF), An indicator in pulmonary function test to stand for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second, 1-6 months|Maximum voluntary ventilation (MVV), An indicator in pulmonary function test to measure the maximum amount of air that can be inhaled and exhaled within one minute, 1-6 months|6-minute-walk test (6MWT), An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases, 1-6 months|Modified medical research council (MMRC) chronic dyspnea scale, An indicator to evaluate the level of dyspnea, 1-6 months|St. George s respiratory questionnaire (SGRQ) scale, A questionnaire to assess life quality affected by the respiratory problems, 1-6 months

First Affiliated Hospital of Shantou University Medical College

Regend Therapeutics|Tongji University

ALL

ADULT, OLDER_ADULT

EARLY_PHASE1

OTHER

INTERVENTIONAL

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

2017112

2017-04-01

2021-12-31

2022-06-30

2017-05-17

2017-05-17

the First Affiliated Hospital of Shantou University Medical College, Shantou, Guang Dong, 515041, China

{ "bronchial basal cells": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00076973

An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)

https://clinicaltrials.gov/study/NCT00076973

COMPLETED

The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.

NO

Bronchiolitis

DRUG: montelukast sodium|DRUG: Comparator: placebo

Percentage of Symptom-Free Days

Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days

Organon and Co

ALL

CHILD

PHASE3

INDUSTRY

INTERVENTIONAL

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

0476-272|Formerly 0112BRS|MK0476-272|2004_098

2003-08

2006-06

2006-10

2004-02-16

2022-02-02

{ "Montelukast": [ { "intervention_type": "DRUG", "description": "montelukast sodium", "name": "Montelukast", "synonyms": [ "Mont\u00e9lukast", "Montelukast", "Singulair", "(R-(E))-1-(((1-(3-(2-(7-Chloro-2-quinolinyl)ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)propyl)thio)methyl)cyclopropaneacetic acid", "1-[[[(1 R)-1-[3-[(1E)-2-(7-chloro-2-quinolinyl)ethenyl] phenyl]-3-[2-(1-hydroxy-1-methylethyl)phenyl]propyl]sulfanyl]methyl]cyclopropaneacetic acid", "Montelukastum" ], "medline_plus_id": "a600014", "generic_names": [ "Montelukast" ], "nhs_url": "https://www.nhs.uk/medicines/montelukast", "drugbank_id": "DB00471", "wikipedia_url": "https://en.wikipedia.org/wiki/Montelukast" } ], "Comparator: placebo": [ { "intervention_type": "DRUG" } ] }

NCT04676373

Study to Evaluate Efficacy and Safety in Chinese Patients With Late Onset Pompe Disease With Alglucosidase Alfa Treatmen

https://clinicaltrials.gov/study/NCT04676373

APOLLO-LOPD

ACTIVE_NOT_RECRUITING

Primary Objective: To evaluate the effect of one-year Alglucosidase alfa treatment on motor function [Six-minute walk test (6MWT) and lung function predicted Forced vital capacity (FVC)] among Chinese Late Onset Pompe Disease patients above 5 years old. To evaluate the safety of Myozyme 20mg/kg, IV biweekly in Chinese LOPD patients above 3 years old. Secondary Objective: To evaluate the effect of one-year treatment with Alglucosidase alfa on improvement of manual muscle test (MMT), Maximal inspiratory and expiratory pressure (MIP and MEP)], Quick Motor Function Test scores, and health-related quality of life (SF-12) among LOPD patients over 5 years old.

NO

Pompe s Disease

DRUG: ALGLUCOSIDASE ALFA

Change from baseline in Six-minute walk test (6MWT) for the patients ≥5-year old, This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes., Baseline to 12 months|Change from baseline in percent predicted forced vital capacity (%FVC) in upright position for the patients ≥5-year old, The measurements of pulmonary function and respiratory strength including FVC, MEP and MIP use a pneumograph or the spirometry system with the patient in upright seated and supine positions, according to American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines., Baseline to 12 months|Number of participants with adverse events Number of AEs, An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment., From signing the ICF to the 30th day after the last dosage of the study medications

Change from baseline in maximal inspiratory pressure (MIP) in upright position for the patients ≥5-year old, The measurements of pulmonary function and respiratory strength including FVC, MEP and MIP use a pneumograph or the spirometry system with the patient in upright seated and supine positions, according to American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines., Week 52|Change from baseline in maximal expiratory pressure (MEP) in upright position for the patients ≥5-year old, The measurements of pulmonary function and respiratory strength including FVC, MEP and MIP use a pneumograph or the spirometry system with the patient in upright seated and supine positions, according to American Thoracic Society (ATS) and European Respiratory Society (ERS) guidelines., Week 52|Change from baseline in manual muscle test (MMT) for deltoid muscle, quadriceps femoris, iliopsoas, neck stretch flexor for the patients ≥5-year old, MMT has been reported most often as a summary score of a total number of proximal, distal, and axial muscle groups tested bilaterally or as a proximal score that sums a number of proximal muscle groups from the upper and lower extremities., Week 52|Change from baseline in Quick Motor Function Test scores for the patients ≥5-year old, The Quick Motor Function Test is a reliable and valid test for assessing motor function in patients with Pompe s disease., Week 52|Change from baseline in Quick Motor Function Test scores for the patients ≥5-year old, The 12-Item Short Form Health Survey (SF-12) was developed for the Medical Outcomes evaluation of patients with chronic conditions., Week 52

Genzyme, a Sanofi Company

ALL

CHILD, ADULT, OLDER_ADULT

PHASE4

INDUSTRY

INTERVENTIONAL

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

ALGMYL09010|U1111-1238-1267|LPS15677

2021-03-10

2024-07-25

2024-07-25

2020-12-21

2024-03-08

Investigational Site, China, China

{ "Alglucosidase alfa": [ { "intervention_type": "DRUG", "description": "ALGLUCOSIDASE ALFA", "name": "Alglucosidase alfa", "synonyms": [ "alpha-1,4-glucosidase", "Myozyme", "Alpha-glucosidase", "Alglucosidase alfa", "Lumizyme", "Human acid precursor alpha-glucosidase, recombinant", "Aglucosidase alpha", "Alglucosidasa alfa", "Acid maltase", "Lysosomal Alpha-Glucosidase", "Aglucosidase alfa", "Acid-alpha glucosidase" ], "drugbank_id": "DB01272", "generic_names": [ "Alglucosidase alfa" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Alglucosidase%20alfa" } ] }

NCT00006273

Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis

https://clinicaltrials.gov/study/NCT00006273

UNKNOWN

OBJECTIVES: I. Compare the resting energy expenditure using respiratory calorimetry in infants and children with moderate to severe cystic fibrosis versus age matched healthy controls. II. Determine the total energy expenditure and energy spent on physical activity using the doubly labeled water method in these patient populations.

NO

Cystic Fibrosis

National Center for Research Resources (NCRR)

Indiana University School of Medicine

ALL

CHILD

NIH

OBSERVATIONAL

Observational Model: |Time Perspective: p

NCRR-M01RR00750-9040|IU-9509-20

1996-06

2000-09-12

2005-06-24

Indiana University, Indianapolis, Indiana, 46202-5167, United States

{}

NCT06303973

Effect of Oral Enteral Nutrition in Pierre Robin Syndrome

https://clinicaltrials.gov/study/NCT06303973

COMPLETED

This was a randomized controlled study. The infants enrolled were randomly divided into the IOE group (with Intermittent Oro-Esophageal Tube Feeding, n=25) and the PNG group (with Nasogastric Tube Feeding, n=23), all receiving systemic therapy. Before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

NO

Pierre Robin Syndrome

DEVICE: IOE|DEVICE: PNG

Number of patients diagnosed as the pulmonary infection Positive ., Once the symptoms of respiratory tract infection such as fever, cough, sputum, dyspnea, and respiratory distress were observed, the medical staffs would conduct the future exam. With the presence of rales on auscultation of both lungs, examination by CT, the routine blood test, and blood culture, the patients would be diagnosed as the pulmonary infection Positive ., Day 1 and Day 28

Nutritional status-total protein, The relevant indicators include total protein (TP, g/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning., Day 1 and Day 28|Nutritional status-hemoglobin, The relevant indicators include hemoglobin (Hb, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning., Day 1 and Day 28|Nutritional status-albumin, The relevant indicators include albumin (ALB, g/L)from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning., Day 1 and Day 28|Nutritional status-prealbumin, The relevant indicators include prealbumin (PA, mg/L) from the blood test within 24h after admission and the last day of treatment, generally, with empty-stomach infants and in the morning., Day 1 and Day 28|Body weight, Body weight measurement of the infants was conducted by the same nurse according to the relevant standards., Day 1 and Day 28|Swallowing function, The water drinking test (WDT) was used to assess the swallowing function due to the low feasibility of using swallowing imaging or flexible laryngoscopy in the infants with PRS and that these patients were unable to communicate and cooperate to complete the subjective components of most questionnaires. The patients were required to sit and drink 30 mL of warm water. Based on the completion of water intake and the occurrence of coughing, the results were divided into levels 1 to 6, with higher levels indicating a more severe degree of dysphagia., Day 1 and Day 28

Muhammad

ALL

CHILD

OTHER

INTERVENTIONAL

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

IOE-PRS

2022-01-10

2023-06-02

2023-06-15

2024-03-12

2024-03-12

Renai Hospital, Yilan, Taiwan

{ "IOE": [ { "intervention_type": "DEVICE" } ], "PNG": [ { "intervention_type": "DEVICE" } ] }

NCT03640273

Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients

https://clinicaltrials.gov/study/NCT03640273

COMPLETED

1. To compare the effectiveness of Prapchompoothaweep crude drug at 3,000 mg per day and Loratadine 10 mg per day for treatment in Allergic Rhinitis patients. (Clinical Trial Phase II) 2. To evaluate the safety and adverse effect of Prapchompoothaweep crude drug at 3,000 mg and Loratadine 10 mg for Allergic Rhinitis patients.

NO

Allergic Rhinitis|Adverse Drug Event|Quality of Life

DRUG: Prapchompoothaweep remedy|DRUG: Loratadine 10 Mg

Nasal cavity Change from baseline at 6 weeks, Using an Acoustic Rhinometry to evaluate nasal symptoms, week-0, week-3 and week-6

Assessment of well-being of volunteer that change from baseline at 6 weeks., Using Rhinoconjunctivitis Questionnaire of Life (Thai Version copyright by Chaweewan Bunnag MD) This questionnaire is designed to find out how your health and well-being have been affected by rhinoconjunctivitis. score including 1-5 score; 1 = not at all, 2 = Slightly, 3 = moderately, 4 = A lot and 5 = Extremely., week-0, week-3 and week-6|Nasal symptoms Change from baseline at 6 weeks., Using Total Nasal Symptom Score Questionnaire. This questionnaire is designed to estimate how severe of your nasal symptom. the questionnaire including the question of 4 symptom of Allergic Rhinitis; sneezing, nasal congestion, nasal itching and runny nose. the score was divided in 4 mark, 0-not at all, 1=slightly, 2=moderate,3=severe., week-0, week-3 and week-6|Renal Function Change from baseline at 6 weeks., to evaluate the adverse events by hematology test of renal function which including BUN (mg/dL) and Creatinine (mg/dL). Normal range of BUN and Creatinine are 7.0-18.0 mg/dL and 0.67-1.17 mg/dL respectively., week-0, week-3 and week-6|Liver Function Change from baseline at 6 weeks., to evaluate the adverse events by hematology test of liver function which including AST (U/L), ALT (U/L), Total Alkaline Phosphatase (U/L), total bilirubin (mg/dl), direct-bilirubin (mg/dl), Globulin (g/dl), Albumin (g/dl) and Total protein (g/dl). Normal range of AST, ALT, Alkaline Phosphatase, total bilirubin, direct-bilirubin, globulin, albumin and total protein are 16-37 U/L, 16-63 U/L, 46-116 U/L, 0.2-1.0 mg/dl, 0.0-0.2 mg/dl, 1.5-3.5 g/dl, 3.4-5.0 g/dl and 6.4-8.2 g/dl respectively., week-0, week-3 and week-6

Thammasat University

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

Thammasat

2017-11-23

2018-01-04

2018-06-24

2018-08-21

2018-08-22

Thammasat University, Khlong Luang, Pathumthani, 12120, Thailand

{ "Prapchompoothaweep remedy": [ { "intervention_type": "DRUG" } ], "Loratadine": [ { "intervention_type": "DRUG", "description": "Loratadine 10 Mg", "name": "Loratadine", "synonyms": [ "Sch 29851", "Loratadina", "Claritin", "Clarium", "Claratyne", "Dimetapp", "Sch-29851", "4-(8-Chloro-5,6-dihydro-11H-benzo(5,6)cyclohepta(1,2-b)pyridin-11-ylidene)-1-piperidinecarboxylic Acid Ethyl Ester", "Agistam", "Wal-itin", "Clarityn", "Sch29851", "Alavert", "Loratadinum", "Loratadine" ], "medline_plus_id": "a697038", "generic_names": [ "Loratadine" ], "nhs_url": "https://www.nhs.uk/medicines/loratadine", "mesh_id": "D039563", "drugbank_id": "DB00455", "wikipedia_url": "https://en.wikipedia.org/wiki/Loratadine" } ] }

NCT03086473

Early Caffeine in Preterm Neonates

https://clinicaltrials.gov/study/NCT03086473

UNKNOWN

This is a clinical trial which will investigate whether administration of caffeine, a respiratory stimulant, to preterm babies soon after birth can prevent the need for a breathing tube, or intubation. Many preterm babies who require intubation are intubated soon after birth, often within the first few hours. If caffeine is given early enough and is sufficient to stimulate effective breathing, perhaps these babies may not require intubation. Additionally, caffeine may improve blood flow in preterm babies when given soon after birth. Approximately half of babies in this study will receive caffeine within two hours after birth, and half will receive caffeine 12 hours after birth. The hypothesis is that preterm babies who receive caffeine within 2 hours after birth will have a lower incidence of intubation than preterm babies who receive caffeine 12 hours after birth. The main secondary hypothesis is that caffeine given soon after birth will enhance blood flow in preterm babies.

NO

BPD - Bronchopulmonary Dysplasia|Apnea of Prematurity|Hemodynamic Instability|Intubation

DRUG: Caffeine Citrate|DRUG: Placebo (Normal Saline)

Intubation, Need for endotracheal intubation within the first 12 hours of life., Within 12 hours of life

Cardiac output, Changes in cardiac output after administration of caffeine., Prior to and 1 hour after receipt of caffeine/placebo at 2 hours of life and 12 hours of life

Jennifer Shepherd

The Gerber Foundation

ALL

CHILD

PHASE4

OTHER

INTERVENTIONAL

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

HS-15-00899

2017-02-01

2022-01

2022-07

2017-03-22

2021-08-03

Hollywood Presbyterian Medical Center, Los Angeles, California, 90027, United States|LAC+USC Medical Center, Los Angeles, California, 90033, United States

{ "Caffeine Citrate": [ { "intervention_type": "DRUG" } ], "Placebo (Normal Saline)": [ { "intervention_type": "DRUG" } ] }

NCT02502773

Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch (FLASH Study)

https://clinicaltrials.gov/study/NCT02502773

FLASH

COMPLETED

The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery.

NO

Postoperative Morbidity|Postoperative Mortality

DRUG: Hydroxethyl starch

Renal dysfunction, Renal dysfunction (defined by KDIGO stage 1 or higher), during the first 14 postoperative days|Pulmonary complication, Pulmonary complication (defined by the need for noninvasive or invasive ventilatory assistance for postoperative acute respiratory failure), during the first 14 postoperative days|Cardiovascular complication, Cardiovascular complication (defined by the development of acute heart failure), during the first 14 postoperative days|Infectious complication, Infectious complication (defined by the development of sepsis, severe sepsis or septic shock), during the first 14 postoperative days|Surgical complication, Surgical complication (defined as the need for surgical reoperation), during the first 14 postoperative days

Total fluid volume, Total fluid volume (0.9% saline and HES 130/0.4), during the surgical period and the first 24 postoperative hours|Volume of blood loss, during the surgical period and the first 24 postoperative hours|Renal complications : oliguria, Postoperative complications, within 14 days|Cardiovascular complications, Postoperative complications, within 14 days|Respiratory complications, Postoperative complications, within 14 days|SIRS score, Postoperative complications, within 14 days|Infectious complications, Postoperative complications, within 14 days|Surgical complications, Postoperative complications, within 14 days|Severity organ failure assessment score from postoperative, Day-1 to Day-7|Unexpected ICU admission (or readmission) following surgery, within 28 days|All-cause mortality, 28 days|All-cause mortality, 3 months|Serum lactate, from Day-1 to Day-7|C-reactive protein, from Day-1 to Day-7|Plasma chloride, from Day-1 to Day-7|number of units of packed red blood cells, during the surgical period and the first 24 postoperative hours

University Hospital, Clermont-Ferrand

Agence Nationale de sécurité du Médicament|Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier)|Société Française Anesthesie-Réanimation (SFAR)

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

CHU-0242|2014-005575-84

2016-02

2018-07-22

2018-10-22

2015-07-20

2019-02-21

CHU Clermont-Ferrand, Clermont-Ferrand, 63003, France

{ "Hydroxethyl starch": [ { "intervention_type": "DRUG" } ] }

NCT04638673

NeuroCovid Rehab and Recovery Related to COVID-19 Diagnosis

https://clinicaltrials.gov/study/NCT04638673

COMPLETED

The purpose of the research is to test out a new form of treatment that examines stimulation of a nerve in the participant s ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that the participant will receive stimulation through the ear. The taVNS device looks like an ear bud used with a smart phone or computer. The study team is investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms the participant may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.

YES

Coronavirus|Covid19

DEVICE: Soterix taVNS model 0125-LTE Stimulator - Active-Active Group|DEVICE: Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group

Change in Score of Patient Health Questionnaire-9, The Patient Health Questionnaire-9 (PHQ-9) is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. Scores range from 0-27. Higher scores mean worse symptoms. Remission -minimal to absence of symptoms; PHQ-9 score < 5. Response -50% or greater decrease in PHQ-9 baseline severity; residual symptoms remain. Partial Response -26% to 49% decrease in PHQ-9 baseline severity. Non-response -less than 25% decrease in PHQ-9 baseline severity., Baseline and week 4 (End of Treatment)

Medical University of South Carolina

National Institutes of Health (NIH)|National Institute of General Medical Sciences (NIGMS)

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

00101270|U54GM104941-08

2020-11-19

2021-06-30

2021-06-30

2020-11-20

2022-07-26

2022-07-26

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

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT04638673/Prot_SAP_001.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT04638673/ICF_000.pdf

{ "Soterix taVNS model 0125-LTE Stimulator - Active-Active Group": [ { "intervention_type": "DEVICE" } ], "Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group": [ { "intervention_type": "DEVICE" } ] }

NCT02979873

Sirolimus (Rapamune ) for Relapse Prevention in People With Severe Aplastic Anemia Responsive to Immunosuppressive Therapy

https://clinicaltrials.gov/study/NCT02979873

RECRUITING

Background: People with severe aplastic anemia (SAA) do not make enough red and white blood cells, and/or platelets. Their body s immune system stops the bone marrow from making these cells. The treatment cyclosporine leads to better blood counts. But when this treatment is stopped, the disease may return in 1 in 3 people. The drug sirolimus may help by suppressing the immune system. Objective: To evaluate and compare the usefulness of sirolimus in preventing aplastic anemia from returning after cyclosporine is stopped, compared with stopping cyclosporine alone. Eligibility: People ages 2 and older with SAA who: Have responded to immunosuppressive therapy that includes cyclosporine, and continue to take cyclosporine Are not taking drugs with hematologic effects Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Bone marrow biopsy: The area above the hipbone will be numbed. A thin needle will remove some bone marrow. Participants will be randomly assigned to a group. All will stop cyclosporine. Group 1 will take sirolimus by mouth at the same time each day for 3 months with close monitoring. Group 2 will not receive the study drug but will be monitored closely. Participants will have clinical tests for the first 3 months: Weekly blood test Monthly fasting blood test For group 1, measurements of sirolimus in the blood every 1 2 weeks Participants will have clinic visits at 3 months, 12 months, and annually for 5 years after the study starts. They may have another visit if their SAA returns. These will include: Blood and urine tests Bone marrow biopsy

NO

Severe Aplastic Anemia

DRUG: Sirolimus

To determine if the rate of relapse at 24 months after CSA discontinuation can be improved by conversion to sirolimus in severe aplastic anemia patients who have responded to IST., Rate of relapse in both arms, 24 months

Safety and tolerability of sirolimus., 3 mo

National Heart, Lung, and Blood Institute (NHLBI)

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2

NIH

INTERVENTIONAL

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

170019|17-H-0019

2016-12-19

2024-08-31

2024-08-31

2016-12-02

2024-06-13

National Institutes of Health Clinical Center, Bethesda, Maryland, 20892, United States

{ "Sirolimus": [ { "intervention_type": "DRUG", "description": "Sirolimus", "name": "Sirolimus", "synonyms": [ "AY 22-989", "AY 22989", "Rapamune", "Rapamycin", "I2190A", "I-2190A", "Sirolimus", "Fyarro", "I 2190A", "Sirolimusum", "Sirolim\u00fas", "AY 22 989", "(-)-Rapamycin", "Fyarro", "Sirolimus (with albumin)", "Fyarro", "Sirolimus (with albumin)" ], "medline_plus_id": "a602026", "generic_names": [ "Sirolimus", "Sirolimus (with albumin)", "Sirolimus (with albumin)" ], "mesh_id": "D007166", "drugbank_id": "DB00877", "wikipedia_url": "https://en.wikipedia.org/wiki/Sirolimus" } ] }

NCT05068973

Evaluation of the NOVATECH ® LUCIOLA TM EB Fiducial Marker During Radiotherapy Sessions in Lung Cancer Patients

https://clinicaltrials.gov/study/NCT05068973

LUCIOLA

RECRUITING

Following CE certification, this Post Market Clinical Follow-up investigates the performance and safety of using the new fiducial marker, NOVATECH® LUCIOLA™ EB, in the lung airways to monitor in real-time tumor location during radiotherapy. At the time of insertion near the tumor, the Luciola s 3 fiducial marker arms are deployed simultaneously. Optimal detection of the fiducial marker is considered during the radiotherapy treatment.

NO

Lung Cancer

DEVICE: NOVATECH® LUCIOLA™ EB - (Fiducial Marker)

LUCIOLA implant s performance during radiotherapy (RT) treatment: tracking rate, Number of RT sessions during which the LUCIOLA implant was used for treatment in relation to the total number of RT sessions. If LUCIOLA can be detected and used for treatment, the patient will attend 3 to 5 RT sessions over a period lasting 1 to 2 weeks., Takes place 4-6 weeks after implantation

Luciola implant visibility , Average of the visibility rate (number of visible LUCIOLA implant arm(s) (0,1,2 or 3) compared to the total number of LUCIOLA implant arms (3)) for all the LUCIOLA implants for the entire radiotherapy treatment, From the dosimetry visit (week 2-4 after implantation) to the last RT session (3-4 weeks after dosimetry)|Global migration rate, Number of LUCIOLA implants which have migrated between the beginning (dosimetry visit) and end of treatment follow-up (12 weeks after last radiotherapy session) in relation to the total number of LUCIOLA implants, Dosimetry CT-Scan takes place 2-4 weeks after implantation; End of treatment CT-Scan takes place 12 weeks after last radiotherapy session|Adverse events, Occurrence rate of adverse or unexpected events which took place between implantation and up to 3 months following the RT treatment s end., 4.5 to 6 months (from implantation to the end of participant s enrollment in the study)|Replanning radiotherapy treatment, Replanning rate = Number of replanning versus total number of sessions for all of the participants., During radiotherapy sessions (4-6 weeks after implantation)|Radiotherapist s satisfaction, Number of participants for whom the radiotherapist is satisfied in relation to the total number of participants., End of study visit: 12 weeks after last radiotherapy session|Pulmonologist s satisfaction, Number of procedures at the end of which the pulmonologist is satisfied in relation to the total number of procedures The following questions will be considered: * Easy introduction of the LUCIOLA delivery system in the guide sheath * Easy placement (release) of the LUCIOLA device at the implantation site * Change of the position after LUCIOLA implant release, Within 24 hours after implantation|Tumoral response, Tumoral response rate according to RECIST criteria between the inclusion CT-Scan and the radiotherapy end of treatment CT-Scan., Between the inclusion CT-Scan (8 weeks prior to implantation at the most) and the radiotherapy end of treatment CT-Scan (12 weeks after last RT session)

Hospital St. Joseph, Marseille, France

NOVATECH SA

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

LUCIOLA 2020_10_02

2021-11-18

2024-09-01

2025-03-01

2021-10-06

2023-01-27

Centre de radiothérapie Francois Baclesse, Caen, 14000, France|Hopital Saint Joseph, Marseille, 13008, France|Hôpital Privé Clairval-Ramsay Santé, Marseille, 13009, France|CHU Rouen, Rouen, 76000, France|Centre de radiothérapie Henri Becquerel, Rouen, 76038, France

{ "NOVATECH\u00ae LUCIOLA\u2122 EB - (Fiducial Marker)": [ { "intervention_type": "DEVICE" } ] }

NCT04350073

Longitudinal Energy Expenditure and Metabolic Effects in Patients With COVID-19 (LEEP-COVID)

https://clinicaltrials.gov/study/NCT04350073

COMPLETED

This current proposal evaluates the Longitudinal Energy Expenditure and Metabolic Effects in Patients with COVID-19 (LEEP-COVID) to understand, guide and optimize our metabolic and nutritional care of these high risk patients. As no data exist for the metabolic effects of COVID-19 patients, this data is urgently needed and essential to assist in the care of COVID-19 patients worldwide. We are uniquely positioned at Duke to perform this research, as we are the only US center with 2 of the FDA-approved devices in existence currently capable of collecting this vital data to guide the care of COVID-19 patients worldwide.

NO

COVID-19

DEVICE: Q-NRG Metobolic Cart Device|DEVICE: MuscleSound Ultrasound|DEVICE: Multifrequency Bioimpedance Spectroscopy

Metabolic and Nutritional Needs of COVID-19 Patients: Measured by Changes of Resting Energy expenditure(REE) over time, as measured by the indirect calorimetry Q-NRG device, The amount of CO2 produced combined with O2 consumed is called the REE (kcal/day) and is measured by the gases exchanged at the mouth., Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)|Metabolic and Nutritional Needs of COVID-19 Patients:Changes of the Respiratory Exchange Ratio (RER) as measured by the indirect calorimetry Q-NRG device, RER (ratio of CO2 produced to O2 consumed is called the respiratory exchange ratio (RER) and is measured by the gases exchanged at the mouth, Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)|Cardiac Output and Cardiac Measures (non-invasive) in COVID-19 patients, Non-invasive, accurate calculation of cardiac output and other cardiac function measurements via Fick equation using direct measurement of VO2 & VCO2. As COVID-19 is known to have significant risk of cardiac failure & cardiac death this may allow early detection of cardiac changes that otherwise may not be recognized in these patients who will not routinely have invasive cardiac monitoring (I.e. Swan-Ganz catheter), Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)

Muscle Mass and Quality Changes from COVID-19: Measured via Changes of Intramuscular Adipose Tissue (IMAT) Content From CT Scans of the Psoas at the Level of L3/Th3, Measures the change over time of (standard of care) CT-derived area of intramuscular muscle mass and adipose tissue in cm2, Up to 1 year|Muscle Mass, Quality, Glycogen Changes in COVID-19: Via Metabolic/Muscle Imaging Derived From Muscle-Specific Ultrasound of Leg/Intercostal/Head Muscles, The change over time of Ultrasound-derived muscle mass, muscle glycogen, and area of intramuscular adipose tissue in % and intramuscular glycogen content (IMGC) from rectus femurs - vastus laterals - intercostalis - temporalis - styloglossys, Every 3 days (+/- 1 day) while in ICU and then every 5 days (+/- 2 days) for the remainder of hospital stay. Maximum frequency, if requested by the clinical team (for the purposes of clinical care) can be up to once a day, every day.)|Body Composition in COVID-19 Patients: Measured via Multifrequency Bioimpedance Spectroscopy, Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)|Phase Angle in COVID-19 Patients: Measured via Multifrequency, Minimum of every other day while in ICU (up to 10 days). Once discharged from ICU minimum of 3x a week until discharge (up to 3 weeks)

Duke University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Pro00105221

2020-04-20

2022-08-22

2022-08-22

2020-04-16

2023-05-16

Duke University Medial Center, Durham, North Carolina, 27710, United States

{ "Q-NRG Metobolic Cart Device": [ { "intervention_type": "DEVICE" } ], "MuscleSound Ultrasound": [ { "intervention_type": "DEVICE" } ], "Multifrequency Bioimpedance Spectroscopy": [ { "intervention_type": "DEVICE" } ] }

NCT06077773

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects With Chronic Spontaneous Urticaria

https://clinicaltrials.gov/study/NCT06077773

CALM-CSU

RECRUITING

Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP262 in Subjects with Chronic Spontaneous Urticaria

NO

Chronic Spontaneous Urticaria

DRUG: Oral EP262|DRUG: Placebo

Change in Urticaria Activity Score (UAS) over a 7-day period (UAS7), Assessed using the UAS7 measuring the intensity of itch and number of hives over the past 7 days, Measured from Baseline to Week 6

Safety and tolerability of EP262, Assessed by the incidence of treatment-emergent adverse events, Measured from Day 1 to End of Study or Early Termination (up to 10 weeks)|Change in Itch Severity Score (ISS) over a 7-day period (ISS7), Assessed using the ISS7 measuring the intensity of itch over the past 7 days, Measured from Baseline to Week 6|Change in Hive Severity Score (HSS) over a 7-day period (HSS7), Assessed using the HSS7 measuring the number of hives over the past 7 days, Measured from Baseline to Week 6

Escient Pharmaceuticals, Inc

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

EP-262-201

2023-09-25

2025-01

2025-02

2023-10-11

2024-06-24

AllerVie Clinical Research, Birmingham, Alabama, 35209, United States|Little Rock Allergy & Asthma Clinical Research Center, Little Rock, Arkansas, 72205, United States|First OC Dermatology Research, Inc., Fountain Valley, California, 92708, United States|Allergy and Asthma Specialists Medical Group, Huntington Beach, California, 92647, United States|Antelope Valley Clinical Trials, Los Angeles, California, 90025, United States|University of Miami Itch Center, Miami, Florida, 33136, United States|Advanced Clinical Research Institute, Tampa, Florida, 33607, United States|Treasure Valley Medical Research, Boise, Idaho, 83706, United States|The Indiana Clinical Trials Center, Plainfield, Indiana, 46168, United States|Allergy & Asthma Specialists, P.S.C., Owensboro, Kentucky, 42301, United States|Johns Hopkins University, Baltimore, Maryland, 21224, United States|Chesapeake Clinical Research, Inc., White Marsh, Maryland, 21162, United States|Allergy Partners Clinical Research, Asheville, North Carolina, 28803, United States|Bernstein Clinical Research Center, LLC, Cincinnati, Ohio, 45236, United States|Toledo Institute of Clinical Research Inc., Toledo, Ohio, 43617, United States|Vital Prospects Clinical Research Institute, PC, Tulsa, Oklahoma, 74136, United States|Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania, 15241, United States|National Allergy and Asthma Research, LLC., North Charleston, South Carolina, 29420, United States|Progressive Clinical Research, PA, San Antonio, Texas, 78213, United States|Allergy Associates of Utah, Murray, Utah, 84107, United States|Red Maple Trials Inc., Ottawa, Ontario, K1H1E4, Canada|Evidence Based Medical Educator Inc, Toronto, Ontario, M5G 1E2, Canada|Centre de Recherche Saint-Louis, Québec, Quebec, Canada|Gordon Sussman Clinical Research, North York, M3B 3S6, Canada|Medizinische Hochschule Hannover, Hannover, Niedersachsen, 30625, Germany|Universitatsmedizin Mainz der Johannes Gutenberg-Universitat, Mainz, Rheinland-Pfalz, 55131, Germany|Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Sachsen, 01307, Germany|Institut fur Allergieforschung Charite - Universitatsmedizin Berlin, Berlin, 12203, Germany|Centre for Human Drug Research, Leiden, South Holland, 2333 CL, Netherlands|Pim Mswia, Warsaw, Masovian Voivodeship, 02-507, Poland|Prywatna Praktyka Lekarska Ewa Ring, Warszawa, Mazowieckie, 02-482, Poland|Centrum Badan Klinicznych PI-House Sp. z o.o., Gdańsk, Pomorskie, 80-546, Poland|Hospital del Mar, Barcelona, 08003, Spain|Hospital Clinico San Carlos, Madrid, 28040, Spain|Hospital Arnau de Vilanova, Valencia, 46015, Spain

{ "Oral EP262": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT01284673

Characterization of the Cord Blood Stem Cell in Situation of Neonatal Asphyxia

https://clinicaltrials.gov/study/NCT01284673

NEOCORD

COMPLETED

Neonatal anoxic-ischaemic enkephalopathy is a dramatic perinatal complication due to brain asphyxia. Neurological and neurosensory sequelae are frequent in survivors, due to neuronal damage and loss. For the moment, only total or partial body hypothermia can partially prevent cell loss. However, no treatment exists to restore neuronal functions. Cord blood stem cells are a promising treatment for the near future. However, before conducting a clinical trial to evaluate the safety and feasibility of autologous cell therapy in neonatal asphyxia, in vitro characterization of the cord blood stem cell in situation of neonatal asphyxia, compared to normal situation, is needed. The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn. The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. Secondary objectives are to assess such characteristics in conditions of cryo-preservation, compared to fresh cell preparation

NO

Respiratory Distress Syndrome

OTHER: in vitro characterization of the cord blood stem cell

The primary objective of this study is to characterize cord blood stem cells of neonates with neonatal asphyxia and to compare them with those from healthy newborn, The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration., two years

Assistance Publique Hopitaux De Marseille

ALL

CHILD

OTHER

INTERVENTIONAL

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

2010-A00076-33

2010-04

2016-03

2016-03

2011-01-27

2016-08-03

Assistance publique Hopitaux de Marseille, Marseille, bouches du Rhone, 13005, France

{ "in vitro characterization of the cord blood stem cell": [ { "intervention_type": "OTHER" } ] }

NCT00556673

Bronchodilatory Efficacy of a Single Dose QMF149 (Indacaterol Maleate/Mometasone Furoate) Via the Twisthaler® Device in Adult Patients With Asthma

https://clinicaltrials.gov/study/NCT00556673

COMPLETED

This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.

YES

Asthma

DRUG: indacaterol maleate/mometasone furoate|DRUG: placebo to indacaterol maleate/mometasone furoate|DRUG: fluticasone proprionate / salmeterol xinafoate

Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1), FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate., Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).

Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1), FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate., Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1), Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate., Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1), Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate., Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Change From Period Baseline in Trough Forced Vital Capacity (FVC), Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate., Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Change From Period Baseline in Peak Forced Vital Capacity (FVC), Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate., Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Change From Period Baseline in Trough FEV1/FVC Ratio, The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person s vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate., Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).|Change From Period Baseline in Peak FEV1/FVC Ratio, The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person s vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate., Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.|Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate, Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate, Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol, Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate, Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol, Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate, Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.|Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol, Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.

Novartis

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

CQMF149A2204|2007-002360-10

2007-10

2008-04

2008-04

2007-11-12

2013-04-22

2013-04-22

Novartis Investigator Site, Poitiers, 86000, France|Novartis Investigator Site, Berlin, 14050, Germany

{ "Indacaterol": [ { "intervention_type": "DRUG", "description": "indacaterol maleate/mometasone furoate", "name": "Indacaterol", "synonyms": [ "Indacaterol", "Arcapta" ], "medline_plus_id": "a612014", "generic_names": [ "Indacaterol" ], "drugbank_id": "DB05039" }, { "intervention_type": "DRUG", "description": "placebo to indacaterol maleate/mometasone furoate", "name": "Indacaterol", "synonyms": [ "Indacaterol", "Arcapta" ], "medline_plus_id": "a612014", "generic_names": [ "Indacaterol" ], "drugbank_id": "DB05039" } ], "Fluticasone": [ { "intervention_type": "DRUG", "description": "fluticasone proprionate / salmeterol xinafoate", "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" } ], "Salmeterol": [ { "intervention_type": "DRUG", "description": "fluticasone proprionate / salmeterol xinafoate", "name": "Salmeterol", "synonyms": [ "Salmeterolum", "Serevent", "Aeromax", "Salmaterol", "Salmeterol" ], "medline_plus_id": "a695001", "generic_names": [ "Salmeterol" ], "drugbank_id": "DB00938", "wikipedia_url": "https://en.wikipedia.org/wiki/Salmeterol" } ] }

NCT03053973

The Effects of Nocturnal Non-invasive Ventilation in Stable COPD

https://clinicaltrials.gov/study/NCT03053973

RECAPTURE

RECRUITING

Rationale: Application of long-term non-invasive ventilation (NIV) in chronic obstructive pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure (CHRF) has recently been shown to improve outcomes. However, the mechanism behind these improvements are unknown. We hypothesize that NIV stabilizes FEV1 via beneficial effects on inflammation and repair pathways in patients with COPD. In the present study we aim to investigate, in COPD patients with CHRF, 1. change in FEV1 after 3 months nocturnal NIV in stable hypercapnic COPD patients as compared to standard care 2. the relationship between FEV1 change and modification of systemic and airway inflammation and remodelling, lung hyperinflation, and airway morphology. 3. predictors of a favourable response to chronic NIV in COPD patients with CHRF. Study design: multicentre randomised controlled study investigating the effects of NIV on airway morphology, airway inflammation and remodelling in hypercapnic COPD patients including a control group that will postpone the initiation of NIV for 3 months. In addition we will investigate how patient demographics, patient and disease characteristics and systemic and airway inflammation predict the response to chronic NIV in severe stable COPD. To do this, all patients will be followed for 6 months after NIV initiation. Main study parameters/endpoints: The main endpoint is the change FEV1 after 3 months. Furthermore, as we recognise that FEV1 might not be the most important patient-related outcome, we will assess which parameters affect health-related quality of life after 3 and 6 months.

NO

Noninvasive Ventilation

DEVICE: nocturnal noninvasive ventilation|OTHER: Standard Care

FEV1, Change in Forced expiratory volume in one second, baseline, 3 months|Health-Related Quality of Life, Change in HRQoL assessed by the severe respiratory insufficiency questionnaire summary score (SRI), baseline, 3 months, 6 months

Safety: the number of adverse events will be recorded., The number of adverse events will be recorded., baseline, 3 months, and 6 months|Health-related quality of life assessed with the SF-36, Additional assessment of generic and disease specific aspects of HRQoL, evaluated with the SF-36., baseline, 3 months, 6 months|Anxiety and depression, Anxiety and depression, evaluated by the hospital anxiety and depression scale (HADS)., baseline, 3 months, 6 months|Activities and Restrictions,, Activities and Restrictions, assessed with the Groningen Activity and Restriction Scale (GARS)., baseline, 3 months, 6 months|Caregiver Burden, Caregiver Burden, assessed with the Caregiver Strain Index (CSI), baseline, 3 months, 6 months|Dyspnoea, Dyspnoea, using the Medical Research Council (MRC) score., baseline, 3 months, 6 months|Gas exchange day, Gas exchange at daytime without additional oxygen assessed with an arterial blood gas analysis, baseline, 3 months, 6 months|Gas exchange night, Gas exchange during the night assessed with transcutaneous CO2 measurements., baseline, 3 months, 6 months|Respiratory muscle activity, Respiratory muscle activity during the night and during NIV will be assessed with surface electromyography (EMG), baseline, 3 months|Spirometry, Spirometry will be used to assess forced expiratory volumes, baseline, 3 months, 6 months|Exercise tolerance, Exercise tolerance assessed by the 6-minute walking distance., baseline, 3 months, 6 months|Peripheral muscle function, The 1-repetition maximum strength test will performed using a resistance weight-lifting machine, baseline, 3 months|Compliance with the ventilator, Compliance will be read from the ventilator counter readings, baseline, 3 months, 6 months|Venous blood, Venous samples will be obtained for analyses of inflammatory markers, Baseline, 3 months|Urine albumin to Creatinine ratio, Urine portion for albumin and creatinine will be obtained to obtain the albumin to creatinine ratio, Baseline, 3 months|Nasal epithelium markers of remodelling and repair, For detailed description see the airway brush markers., Baseline, 3 months|Airway abnormalities, Airway abnormalities will be assessed with a High Resolution computertomography (HRCT) scanning with in- and expiration., Baseline, 3 months|Airway inflammation and remodeling, Airway inflammation and remodeling assessed with bronchial brushes and washes and airway biopsies obtained through bronchoscopy. Several markers leading to one profile will be assessed, Baseline, 3 months|HRQoL assessed with CCQ, Additional assessment of generic and disease specific aspects of HRQoL, evaluated with the Clinical COPD Questionnaire (CCQ)., Baseline, 3 months, 6 months|Patient-ventilator asynchrony, Patient-ventilator asynchrony during the night and during NIV will be assessed by comparing surface electromyography (EMG) signals with ventilator pressure tracings, baseline, 3 months|Lung volumes, Bodyplethysmography will be used to assess lung volumes, baseline, 3 months, 6 months|Emphysema, The amount of emphysema and air-trapping assessed with a High Resolution computertomography (HRCT) scanning with in- and expiration, and captured into an emphysema score., baseline, 3 months

Peter Wijkstra

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

201700097

2017-11-13

2025-08-01

2025-11-01

2017-02-15

2023-11-29

University Medical Center Groningen, Groningen, 9700 RB, Netherlands

{ "nocturnal noninvasive ventilation": [ { "intervention_type": "DEVICE" } ], "Standard Care": [ { "intervention_type": "OTHER" } ] }

NCT01192373

Modulation of Free Fatty Acids in Heart Failure Patients With Diabetes: Effect on Left Ventricular Function

https://clinicaltrials.gov/study/NCT01192373

Metamod3

COMPLETED

The investigators wish to investigate the the short term effect of low circulating free fatty acids in congestive heart failure patients with type 2 diabetes. Hypothesis: Low levels of circulating free fatty acids decrease myocardial and peripheral muscle lipid content, improves cardiac performance and exercise capacity.

NO

Heart Failure|Diabetes

OTHER: Metabolic substrate modulation|OTHER: metabolic substrate modulation

Left ventricular function, Left ventricular systolic function (Ejection fraction, tissue velocity, Strain and strain rate). Left ventricular diastolic funtion (E/A ratio, E/e ratio, IVRT) Cardiac output. All parameters measured at rest and peak exercise and outcome is difference between low and high ciculating free fatty acids., 1-6 weeks|intracellular lipid content, Magnetic Resonans proton spectroscopy (septal myocardial intracellular lipid content) Magnetic Resonans proton spectroscopy (Tibialis anterior muscle intracellular lipid content). Outcome is difference between low and high ciculating free fatty acids., 1-6 weeks|Exercise capacity and oxygen consumption, Using treadmill and continues oxygen consumption measurement. Outcome is difference between low and high ciculating free fatty acids., 1-6 weeks

Regional left ventricular function, regional speckle tracking during rest and peak exercise. Outcome is difference between low and high ciculating free fatty acids., 1-6 weeks|6 minutes hall walk test, distance difference between low and high levels of circulating FFA. Outcome is difference between low and high ciculating free fatty acids., 1-6 weeks|metabolic and hormonal profile, bloodsamples, 1-6 weeks

University of Aarhus

Danish Heart Foundation

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

M20090230

2010-09

2011-03

2012-03

2010-09-01

2013-01-21

Dept. of cardiology, Aarhus University hospital Skejby,, Aarhus, Region Midjylland, 8200, Denmark

{ "Metabolic substrate modulation": [ { "intervention_type": "OTHER" } ], "metabolic substrate modulation": [ { "intervention_type": "OTHER" } ] }

NCT03233373

Thermal Imaging as a Potential Diagnostic Tool of Nasal Airflow

https://clinicaltrials.gov/study/NCT03233373

UNKNOWN

Currently, there are no tools that can measure nasal airflow in an objective manner that is non-invasive to the patient. This clinical study aims to address this by evaluating the use of thermal imaging as a diagnostic tool for measuring nasal airflow. Proper airflow cools the nasal airway as it passes--obstructions or narrowed airways hinder flow and results in elevated temperatures along the airway and nasal tissue. It is this elevation in temperature, or more specifically, loss of cooling, that we hypothesize to be measurable with thermal imaging. Participants in this study will be asked to perform 3-4 nasal breathing cycles which will be recorded by the thermal imager.

NO

Nasal Airway Obstruction

DEVICE: Seek CompactPro thermal imager

Minimum temperature in centigrade of patient s reported better (more patent) and worse (less patent) nasal airway, From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways), through study completion, an average of 1 year

Area of cooling of patient s reported better (more patent) and worse (less patent) nasal airway, From recorded thermal imaging of nasal respiration cycles of both nostrils (nasal airways), through study completion, an average of 1 year

New York City Health and Hospitals Corporation

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2017-8248

2017-09-01

2020-08

2020-09

2017-07-28

2018-09-18

Jacobi Medical Center, Bronx, New York, 10461, United States

{ "Seek CompactPro thermal imager": [ { "intervention_type": "DEVICE" } ] }

NCT05982873

Expanded Access to ABBV-400

https://clinicaltrials.gov/study/NCT05982873

AVAILABLE

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-400 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient s medical history and program eligibility criteria.

NO

Non-Small Cell Lung Cancer

DRUG: ABBV-400

AbbVie

ALL

ADULT, OLDER_ADULT

INDUSTRY

EXPANDED_ACCESS

C24-738

2023-08-09

2024-04-03

{ "ABBV-400": [ { "intervention_type": "DRUG" } ] }

NCT02393573

Attenuating The Post-Operative Insulin Resistance And Promoting Protein Anabolism

https://clinicaltrials.gov/study/NCT02393573

TERMINATED

Major surgery results in a stress- induced catabolic response, marked by post-operative insulin resistance, hyperglycemia and loss of body protein, which is associated with increased morbidity, mortality and adverse outcomes. There has been a great deal of research on different approaches to optimize post-operative insulin sensitivity including hormonal and nutritional interventions, minimally invasive surgical techniques and epidural anesthesia. However, the correlation between insulin resistance and body protein loss is not well understood. Metformin is the most widely used insulin sensitizing and blood glucose-lowering drug in treatment of type 2 diabetic patients. This study will: 1) estimate the correlation between insulin resistance and body protein loss in pre-diabetic lung/colorectal resection patients; 2) investigate whether the post-operative metabolic state can be improved by the pre-operative administration of metformin; and assess the impact of metformin on surgical complications and hospital length of stay. The results of this study will provide insight into the relationship between insulin resistance and post-operative adverse events and potentially suggest a novel approach to improve outcomes using Metformin, a drug already in wide clinical use.

NO

Pre-Diabetes|Major Lung or Abdominal Surgery|Insulin Resistance

DRUG: Metformin|DRUG: Placebo

Change in fasting blood glucose, the level of plasma glucose after 6 hours of fasting, 2 weeks before surgery (pre-operative) and on the morning before the surgery and every morning after the surgery (post operative) for three days or until discharge which ever comes earlier

Change in whole body protein balance, The difference between the Pre-operative whole body protein balance( prior to metformin treatment) and the post operative whole body protein balance, 2 weeks before surgery (pre-operative) and hours after the surgery (post operative)|Comparing the Homeostasis model assessment (HOMA) index at three different time points ( by employing Fasting blood sugar and Plasma Insulin), at 3 time points as follow : 2 weeks before surgery, on the day of surgery and 48 hours after the surgery|glycosylated Hba1c, plasma level of glycosylated Hba1c, 2 weeks before surgery|Comparing the pre-operative body impedance and the post operative body impedance (to asses the body composition specifically the amount of body fat), Measures body composition specifically fat content, 2 weeks before surgery and 48 hours after the surgery|Surgical Complications, Any complication related to the surgery with in 30 days post operation, 30 days after operation|length of hospital stay, Length of hospital stay is calculated as the total length of hospitalization from the date of admission for the purpose of surgery until the date of discharge from the hospital, Up to 30 days after operation

McGill University Health Centre/Research Institute of the McGill University Health Centre

Mitacs|Medtronic - MITG

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

14-264-SDR

2015-11

2018-03

2018-03

2015-03-19

2018-03-23

Montreal General Hospital, Montreal, Quebec, H3G 1A4, Canada

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

NCT02507973

Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury

https://clinicaltrials.gov/study/NCT02507973

TERMINATED

The investigators will conduct an observational crossover study. The investigators aim to recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley Shock Trauma Center. Overall, participants will be monitored, on average, for approximately 6-8 hours during the study period. The investigators do not anticipate the need for prolonged monitoring during the duration of their hospital stay or post hospital period.

YES

Injury, Brain, Traumatic|Traumatic Brain Injury

OTHER: Airway Pressure Release Ventilation|OTHER: Low Tidal Volume Ventilation

Intracranial Pressure, We aim to evaluate the patients during the two modes of ventilation (LTOV and APRV) to determine if there are significant differences in their ICP based on ventilation mode., On average, 24 hours for each patient

University of Maryland, Baltimore

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

HP-00063355

2015-07

2018-04

2018-04

2015-07-24

2020-01-09

2022-01-28

RA Cowley Shock Trauma Center, Baltimore, Maryland, 21201, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT02507973/Prot_SAP_000.pdf

{ "Airway Pressure Release Ventilation": [ { "intervention_type": "OTHER" } ], "Low Tidal Volume Ventilation": [ { "intervention_type": "OTHER" } ] }

NCT05657873

A Study of Targeted Radiation Therapy in People With Non-Small Cell Lung Cancer (NSCLC)

https://clinicaltrials.gov/study/NCT05657873

RECRUITING

The purpose of this study is to see whether adding liver stereotactic ablative radiotherapy/L-SABR to standard drug therapy is better than standard drug therapy alone for people with metastatic non-small cell lung cancer/NSCLC.

NO

Non Small Cell Lung Cancer|Non Small Cell Lung Cancer Metastatic|Non-small Cell Carcinoma|NSCLC|NSCLC Stage IV

RADIATION: L-SABR|BIOLOGICAL: Anti-PD-(L)1 based immunotherapy|DRUG: Platinum based chemotherapy

Median progression-free survival, Primary outcomes is to determine if L-SABR, when added to first line standard of care anti-PD-(L)1 based immunotherapy +/- chemotherapy, can improve median progression-free survival (PFS) in patients with metastatic NSCLC involving the liver., up to 4 years

Memorial Sloan Kettering Cancer Center

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

22-386

2022-12-09

2025-12-09

2025-12-09

2022-12-20

2024-06-13

Memorial Sloan Kettering at Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, 07920, United States|Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, 07748, United States|Memorial Sloan Kettering Bergen (All protocol activities), Montvale, New Jersey, 07645, United States|Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities), Commack, New York, 11725, United States|Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, 10604, United States|Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, 10065, United States|Memorial Sloan Kettering Nassau (All protocol activities), Rockville Centre, New York, 11553, United States

{ "L-SABR": [ { "intervention_type": "RADIATION" } ], "Anti-PD-(L)1 based immunotherapy": [ { "intervention_type": "BIOLOGICAL" } ], "Platinum based chemotherapy": [ { "intervention_type": "DRUG" } ] }

NCT01214473

Probiotics for Prevention Neonatal Infection

https://clinicaltrials.gov/study/NCT01214473

TERMINATED

Neonatal sepsis (serious infection) continues to be one of the major causes of morbidity and mortality in the newborn period around the world. India, with one of the world s largest populations, continues to struggle with extremely high infant and neonatal mortality rates. Sepsis accounts for 50% of deaths among community born (and 20% of mortality among hospital-born) infants. Closely linked with this is a burgeoning problem of antimicrobial resistance, which is increasingly restricting the therapeutic options for medical care providers. Friendly bacteria called Probiotics have been used in multiple infectious and inflammatory disease states in humans. Fructooligosaccharides are sugars found naturally in many fruits and vegetables and also in human breast milk. These sugars reach the colon undigested and serve as food for the friendly bacteria. The current study uses a probiotic preparation containing Lactobacillus plantarum and fructooligosaccharides as an attempt to prevent neonatal infections. Currently no conclusive data are available on the utility of probiotics in such conditions. If successful, such inexpensive preventive therapy can be made available to general public in resource poor countries. Similar preparations can also be used in the western world to prevent similar infectious conditions of the neonatal period, especially in preterm infants where sepsis continues to be a major cause of hospital stay and death.

NO

Neonatal Sepsis|Sepsis|Neonatal Infections

DIETARY_SUPPLEMENT: Synbiotics|DIETARY_SUPPLEMENT: Maltodextrin

Clinical sepsis and/or death, Incidence of clinical sepsis and/or death, During the first 60 days of life

Culture proven sepsis, Incidence of culture proven sepsis (Gram-negative vs. Gram-positive), During the first 60 days of life|Other infections, Incidence of other infections, During the first 60 days of life|Weight gain, Weight gained or lost, During the first 60 days of life

University of Nebraska

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

ALL

CHILD

OTHER

INTERVENTIONAL

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

0332-10 FB|5R01HD053719

2007-06

2012-06

2013-11

2010-10-05

2023-08-23

Ispat General Hospital, Rourkela, Odisha, 769002, India|Center for Advanced Research on Alternative Medicine, Bhubaneswar, Orissa, 751009, India

{ "Synbiotics": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Maltodextrin": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT04477031

Verification of the Safety of Normal Food Before a Cerebral Arteriography

https://clinicaltrials.gov/study/NCT04477031

VIANAC

RECRUITING

Fasting is currently required before elective cerebral angiography, despite numerous arguments against fasting (kidney toxicity, vasovagal reaction, discomfort) and seams unusefull regarding it s main goal : reducing nausea and vomiting. The investigators propose to assess frequency of nausea and vomiting among patients having taken their breakfast at home before day care angiography. The investigators hypothesise that less than 1% of non fasting patients will suffer of vomitint.

NO

Cerebral Angiography

frequency of vomiting during arteriographic procedure, The investigators check if there is vomiting or not during the examination noted by an electro radiology manipulator. Safety issue : Bronchus inhalation, fifteen minutes

nausea, The nausea will be evaluated using an analog visual scale (EVA) by an electro-radiology manipulator (MAR)at the exit of the intervention room, fifteen minutes

Nantes University Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RC17_0396

2020-12-01

2024-12-15

2025-06-15

2020-07-20

2021-09-13

CHU de Nantes, Nantes, 44093, France

{}

NCT05062031

Myopia Control in Children: Comparison of Defocus Incorporated Multiple Segments® Lenses Versus Atropine 0.05% Eyedrops

https://clinicaltrials.gov/study/NCT05062031

ATROSMART

RECRUITING

Myopia is the most common refractive disorder in the world. Many strategies have been developed to control myopia in children. Among them, the instillation of low-concentration atropine eyedrops has been proven to be effective in numerous publications. Nevertheless, the spreading of atropine use is limited by: (1) its uneven availability, (2) a proportion of children with no or poor response, (3) some issues of long-term compliance (4) the possibility of a rebound effect after treatment cessation. Among the non-drug myopia control strategies, corrective lenses including the Defocus Incorporated Multiple Segments® (DIMS®) technology have demonstrated their effectiveness in a previous study (Hong Kong) when compared to monofocal lenses. The aim of this study is to compare the efficacy of DIMS lenses alone versus atropine 0.05% eyedrops + monofocal lenses, on the evolution of ocular axial length at 2 years in myopic children.

NO

Myopia

DEVICE: Defocus Incorporated Multiple Segments® (DIMS®) lenses|DRUG: Atropine 0.05% eyedrops|DEVICE: Monofocal lenses

Axial length measurements, Difference between the mean of 6 axial length measurements (in mm) acquired with the IOLMaster 500® at 24 months and the mean of 6 axial length measurements at inclusion, Inclusion, 24 months|Spherical equivalent, Difference in spherical equivalent (in diopters) under cycloplegia on autorefractometer at 24 months and at preinclusion, Pre inclusion (screening consultation in the 15 days preceding inclusion), 24 months

Fondation Ophtalmologique Adolphe de Rothschild

Ecouter Voir|Hoya Lens France

ALL

CHILD

NETWORK

INTERVENTIONAL

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

GMN_2021_11

2021-10-19

2026-10

2026-10

2021-09-30

2023-10-05

Hôpital Fondation Adolphe de Rothschild, Paris, 75019, France

{ "Defocus Incorporated Multiple Segments\u00ae (DIMS\u00ae) lenses": [ { "intervention_type": "DEVICE" } ], "Atropine": [ { "intervention_type": "DRUG", "description": "Atropine 0.05% eyedrops", "name": "Atropine", "synonyms": [ "Atropina", "Augen\u00f6l, Atropin", "Atropin Augen\u00f6l", "(\u00b1)-atropine", "Atropine Sulfate", "Atropinol", "Sulfate Anhydrous, Atropine", "(\u00b1)-hyoscyamine", "Atropinum", "Atropine Care 1%", "Atropine", "Atropine Sulfate Anhydrous", "dl-Hyoscyamine", "dl-tropyltropate", "Isopto", "Tropine tropate", "Anhydrous, Atropine Sulfate", "Atropin", "Sulfate, Atropine", "AtroPen" ], "medline_plus_id": "a682487", "generic_names": [ "Atropine" ], "mesh_id": "D018727", "drugbank_id": "DB00572" } ], "Monofocal lenses": [ { "intervention_type": "DEVICE" } ] }

NCT02455531

Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type

https://clinicaltrials.gov/study/NCT02455531

SVRIII

ACTIVE_NOT_RECRUITING

The purpose of this study is to compare direct and indirect measures of right ventricular (RV) systolic and diastolic function between 11 year old subjects who had been randomly assigned to receive a right ventricle to pulmonary artery shunt (RVPAS) vs. a modified Blalock-Taussig shunt (MBTS) at the time of the Norwood operation.

NO

Heart Defects

RV ejection fraction (RVEF) at 11 years, as measured by cardiac magnetic resonance (CMR)., 10 to 12 years of age for each participant (11 years ± 1 year)

The incidence of death or cardiac transplantation between those randomized to receive a RVPAS vs. a MBTS at the time of the Norwood operation., 11 years ± 1 year to 16 years|The exercise tolerance between those randomized to a RVPAS vs. a MBTS., 11 years ± 1 year to 16 years|The incidence of arrhythmias between those randomized to a RVPAS vs. a MBTS., 11 years ± 1 year to 16 years|The neurodevelopmental outcomes at 11 years of age in those randomized to a RVPAS vs. a MBTS, 11 years ± 1 year|Develop risk stratification models for 1) cardiac outcomes, 2) transplant-free survival, and 3) neurodevelopmental outcomes., 11 years ± 1 year to 16 years|Collect specimens from subjects and their parents to further develop the biologic specimen repository., 11 years ± 1 year to 16 years

Carelon Research

National Heart, Lung, and Blood Institute (NHLBI)

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

U10HL068270-4b|U10HL068270

2015-06

2020-10

2025-06

2015-05-28

2024-02-08

{}

NCT02673931

GLP-1 and Hyperoxia for Organ Protection in Heart Surgery

https://clinicaltrials.gov/study/NCT02673931

GLORIOUS

ACTIVE_NOT_RECRUITING

Patients undergoing open heart surgery are at risk of suffering damage to the heart, brain and kidneys. This study is designed as a 2-by-2 randomized clinical trial with the purpose of investigating the organ protective effects of the glucagon-like-peptide-1 (GLP-1) agonist Exenatide versus placebo and restrictive versus liberal oxygenation during weaning from cardio-pulmonary bypass.

NO

Coronary Disease|Shock, Cardiogenic|Renal Failure|Stroke|Brain Injury|Aortic Valve Disease

DRUG: Byetta (Lilly, Exenatide)|DRUG: Conoxia (AGA, oxygen)|DRUG: 20% Human Albumin

The presence of a co-primary end-point, 1. Death from any cause or 2. Any of the following adverse events 1. Renal failure requiring any type of renal replacement therapy 2. Stroke, defined as persisting (>24 hours) of any neurological sign or symptom of neurological dysfunction as determined by the treating physician based on available clinical information or CT-scan 3. New onset/worsening heart failure defined as need for mechanical circulatory support at the ICU, inability to close the sternotomy due to post-surgical hemodynamic instability and/or persistent (> 48 hours from initiation of first surgical procedure after randomization) need for inotropic hemodynamic support. In addition admission for heart failure during follow-up following discharge from the index admission., Minimum 12 months

Time in days to the occurrence of individual end-points, 1. Time to death from any cause, or 2. Time to death or stroke, or 3. Time to death or renal dysfunction requiring dialysis, or 4. Time to death or new hospitalization for heart failure during follow-up following discharge from the index admission, or 5. Time to death or new onset/worsening in-hospital heart failure., Minimum 12 months|Incidence of serious adverse events, 1. Surgical site infections with need for antibiotics for more than 48 hours (excluding routine use of antibiotics for open sternum, surgical intervention, and/or endocarditis within 6 months of surgery, or 2. Doubling of S-creatinine or urine output below 0.5 mL/kg/hour for 12 hours or more at any time point during index admission, or 3. Hypoglycemia, defined as blood glucose < 3 mmol/L, during index admission, or 4. Pancreatitis, defined as s-amylase > 3 times upper normal limit, during index admission, or 5. A relative reduction of LVEF of 50% compared to baseline at any time point during index admission, or 6. Re-operation for bleeding during index admission, or 7. Re-operation for any cause during index admission, or 8. Post-surgery MI (Type 5 MI[41]) during index admission, or 9. Re-admission for cardiovascular causes within 12 months, 12 months|Change in Cerebral Performance Category (CPC), Change from baseline in CPC-score, 12 months|Change in modified Rankin Scale (mRS), Change from baseline in mRS, 12 months

Rigshospitalet, Denmark

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

HJE-PHARMA-001

2016-02

2024-01

2024-01

2016-02-04

2023-11-18

Rigshospitalet - Copenhagen University Hospital, Copenhagen, 2100, Denmark

{ "Exenatide": [ { "intervention_type": "DRUG", "description": "Byetta (Lilly, Exenatide)", "name": "Exenatide", "synonyms": [ "Exendin-4", "Exenatide", "Bydureon", "Exenatida", "Byetta", "Exendin 4", "Synthetic exendin-4", "Exenatide synthetic" ], "medline_plus_id": "a605034", "generic_names": [ "Exenatide" ], "drugbank_id": "DB01276" } ], "Conoxia (AGA, oxygen)": [ { "intervention_type": "DRUG" } ], "Albumin human": [ { "intervention_type": "DRUG", "description": "20% Human Albumin", "name": "Albumin human", "synonyms": [ "Albumin human", "Human albumin", "Albumin, human", "Human serum albumin", "Albumin (human)", "Albumin, human-kjda", "Albumin, blood", "Serum albumin" ], "drugbank_id": "DB00062", "generic_names": [ "Albumin human" ] } ] }

NCT02040831

Safety and Immune Response to a Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children

https://clinicaltrials.gov/study/NCT02040831

COMPLETED

Respiratory syncytial virus (RSV) is a common cause of illness in infants and children around the world. This study will evaluate the safety and immune response to an RSV vaccine in RSV-seronegative infants and children. This study is a companion study to IMPAACT 2000.

NO

Respiratory Syncytial Virus Infections

BIOLOGICAL: RSV LID ΔM2-2 Vaccine|BIOLOGICAL: Placebo Vaccine

Frequency of vaccine-related solicited adverse events (AEs) that occur during the acute monitoring phase of the study, the first 28 days after inoculation, Measured through Day 28|Proportion of participants that develop 4-fold or greater rises in RSV neutralizing antibody titer following vaccination, Antibody responses to the RSV F glycoprotein will also be assessed by enzyme-linked immunosorbent assay (ELISA)., Measured through Day 56|Severity of vaccine-related solicited AEs that occur during the acute monitoring phase of the study, the first 28 days after inoculation, Measured through Day 28

National Institute of Allergy and Infectious Diseases (NIAID)

ALL

CHILD

PHASE1

NIH

INTERVENTIONAL

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

CIR 291

2014-09

2015-04

2015-04

2014-01-20

2016-12-21

Center for Immunization Research, JHU, Baltimore, Maryland, 21205, United States

{ "RSV LID \u0394M2-2 Vaccine": [ { "intervention_type": "BIOLOGICAL" } ], "Placebo Vaccine": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00271531

Bacterial Pulmonary Infection in PICU

https://clinicaltrials.gov/study/NCT00271531

COMPLETED

The purpose of this study is to develop a scoring system to allow doctors to accurately identify children on a mechanical ventilator who have bacterial pneumonia. Currently this diagnosis is very difficult to make, resulting in the overuse of antibiotics and the promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four ICUs at 3 children s hospitals will participate. Study participants will include 150 children, ages 2 months to 17 years old who require mechanical ventilation, and in whom the bedside health care providers suspect bacterial pneumonia. Bacteria will be studied by sampling lung fluid through the breathing tube less than 12 hours after starting antibiotics, using a procedure known as non-bronchoscopic-bronchoalveolar lavage (NB-BAL). Participants may be involved in study related procedures for up to 31 days.

NO

Bacterial Infection

Bacterial pneumonia defined as: presence of >10^4 organisms/mL of one or more pathogenic bacterial species or isolation of a pathogenic organism from pleural fluid culture in a patient with a pulmonary infiltrate; persistence of pulmonary infiltrate., Day -1 through Day 3.

Amount of antibiotics, in terms of number and duration, for the treatment of pneumonia used in the study population and separately in subgroups defined by the threshold score for bacterial pneumonia., Duration of study.

National Institute of Allergy and Infectious Diseases (NIAID)

ALL

CHILD

NIH

OBSERVATIONAL

Observational Model: |Time Perspective: p

04-072|BAMSG 4-03

2006-04

2008-05

2008-05

2006-01-02

2011-08-12

Kosair Children s Hospital, Louisville, Kentucky, 40202, United States|Washington University in St. Louis, St. Louis, Missouri, 63110, United States|University Hospitals Case Medical Center, Cleveland, Ohio, 44106, United States|Children s Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States

{}

NCT04540731

Multicenter Registry of Nonalcoholic Fatty Liver Disease

https://clinicaltrials.gov/study/NCT04540731

NOT_YET_RECRUITING

Non-alcoholic fatty liver disease (NAFLD) is the most prevalent liver disease worldwide affecting as much as 25% of the world s population. The spectrum of NAFLD ranges from non-alcoholic fatty liver to non-alcoholic steatohepatitis (NASH), the latter being associated with a progressive course towards fibrosis and a higher risk of developing cirrhosis and hepatocellular carcinoma. Patients with type 2 diabetes are particularly at higher risk of developing fibrosis and advanced liver disease. Since NASH and its consequences will only occur in a minority of patients, it is of paramount importance to identify this population to offer them proper care. It is well known that there is a lack of awareness about the potential consequences of NAFLD, not only in the general population but also in the medical community. Patients with NAFLD are frequently lost during follow up and, additionally, approach to these patients is sub-optimal and heterogeneous among physicians. An attractive approach to applying best medical practices to patients with NAFLD is to generate a multicentre registry. Clinical registries comprise a set of systematic collected and stored data focused on a specific condition. The information stored in a registry provides relevant information about a disease and, through a process of error detection, ensures data quality and reliability. A NAFLD registry is an essential tool for providing relevant information such as epidemiological aspects of the disease, outcomes, and treatment effectiveness. As far as we concern, this would be the first registry of NAFLD in our region, a region where the disease behaves in a more aggressive way in comparison with other regions and hemispheres. By generating this registry, we are confident that we will obtain objective information on the characteristic of patients with NAFLD in our region, not only of the disease characteristics but also of social determinants that might influence disease outcomes. By being a prospective study, it allows an adequate patient follow up.

NO

Non-Alcoholic Fatty Liver Disease

OTHER: This is an observational study without intervention

Non-invasive fibrosis scores progression over time, Change in non-invasive fibrosis scores over time, 5 years|Incidence of cirrhosis, Incidence of cirrhosis, 5 years|Incidence of liver-related complications, Incidence of liver-related complications, defined as any of the following: ascites, encephalopathy, gastroesophageal varices, bleeding gastroesophageal varices or hepatocellular carcinoma, whichever occurs first, 5 years

Fibrosis progression over time, Change in fibrosis score according to liver biopsies over time, 5 years

Hospital Italiano de Buenos Aires

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

5530

2020-10

2025-10

2025-10

2020-09-07

2020-09-07

Hospital Italiano de Buenos Aires, Buenos Aires, 1643, Argentina

{ "This is an observational study without intervention": [ { "intervention_type": "OTHER" } ] }

NCT05739331

Augmented Endobronchial Ultrasound (EBUS-TBNA) With Artificial Intelligence

https://clinicaltrials.gov/study/NCT05739331

RECRUITING

To evaluate the usefulness of Deep neural network (DNN) in the evaluation of mediastinal and hilar lymph nodes with Endobronchial ultrasound (EBUS). The study will explore the feasibility of DNN to identify lymph nodes and blood vessel examined with EBUS.

NO

Artificial Intelligence|Endobronchial Ultrasound|Lung Cancer

DEVICE: machine learning algorithm

Capability, To explore if Deep neural network (DNN) has capability to segment lymph nodes and blood vessels from EBUS images, 8 months

Precision, The precision the DNN has for detecting lymph nodes and blood vessels. Measured both per voxel in the EBUS images and per annotated structure (a structure is counted as detected if at least 50% of its annotated pixels are identified by the DNN)., 2 months|Sensitivity, True positive rate. Correctly detected lymph nodes/blood vessel over total lymph nodes/blood vessel. Measured per pixel in the EBUS images, 2 months|Specificity, Specificity = (True Negative)/(True Negative + False Positive). Measured per pixel in the EBUS images., 2 months|Dice similarity coefficient, Measures the similarity between two sets of data: Annotated by pulmonologist vs DNN., 2 months|Run-time, Is the run-time sufficiently low for real-time analysis during EBUS?, 2 months|Adverse events, Procedure related adverse events or unexpected incidents registered, 48 hours

Norwegian University of Science and Technology

Helse Nord-Trøndelag HF|SINTEF Health Research

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

240245

2023-05-01

2025-05-01

2025-12-01

2023-02-22

2023-11-18

Department of Pulmonology, Levanger Hospital, North Trøndelag Hospital Trust, Levanger, 7600, Norway|Department of Thoracic Medicine, St Olavs Hospital, Trondheim, 7030, Norway

{ "machine learning algorithm": [ { "intervention_type": "DEVICE" } ] }

NCT03443531

Effects of Traditional Chinese Medicine on Bronchiectasis Patients

https://clinicaltrials.gov/study/NCT03443531

UNKNOWN

The aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.

NO

Bronchiectasis

DRUG: Bufei Huatan granule|DRUG: Yifei Qinghua granule|DRUG: Placebo Bufei Huatan granule|DRUG: Placebo Yifei Qinghua granule

The frequency of bronchiectasis exacerbation, The bronchiectasis exacerbations often result in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of bronchiectasis exacerbations over time., Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.

The time to the first bronchiectasis exacerbation, Week 24 of the treatment phase.|Changes in Forced expiratory volume in one second, Forced expiratory volume in one second (FEV1)is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function., Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.

Changes in St Georges respiratory questionnaire scores, Using the St Georges respiratory questionnaire (SGRQ) to asses the impact of Bronchiectasis on a person s life., Changes in the SGRQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.|Changes in the Leicester Cough questionnaire scores, Using the Leicester Cough questionnaire (LCQ) to asses the impact of Bronchiectasis on a person s life., Changes in the LCQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.|Changes in the Quality of Life-Bronchiectasis scores, Using the Quality of Life-Bronchiectasis (Qol-B) to asses the impact of Bronchiectasis on a person s life., Changes in the Qol-B scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.

Henan University of Traditional Chinese Medicine

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

TCM for Bronchiectasis

2018-03

2020-09

2020-12

2018-02-23

2018-02-23

{ "Bufei Huatan granule": [ { "intervention_type": "DRUG" } ], "Yifei Qinghua granule": [ { "intervention_type": "DRUG" } ], "Placebo Bufei Huatan granule": [ { "intervention_type": "DRUG" } ], "Placebo Yifei Qinghua granule": [ { "intervention_type": "DRUG" } ] }

NCT06365931

Physiological and Functional Effects of Percutaneous Neuromodulation vs Transcutaneous Neuromodulation

https://clinicaltrials.gov/study/NCT06365931

ACTIVE_NOT_RECRUITING

INTRODUCTION: Clubfoot, drop foot or clubfoot, is a disorder that prevents reaching 100º of dorsiflexion actively. Its etiology is varied, and may be due to congenital problems, direct alteration of the bone structure, spasticity or shortening of the posterior musculature (triceps suralis), a neurological factor or a combination of several. Thus, we can differentiate between congenital clubfoot and acquired clubfoot. Stroke is one of the main causes of acquired clubfoot, which is due to paralysis of the dorsiflexor musculature and/or spasticity of the plantar flexor musculature. Electrical stimulation is able to increase muscle activation by depolarization of the motor plate and modulation of nerve conduction. This can be done transcutaneously, through surface electrodes or percutaneously through needles, so neuromodulation is presented as a tool applicable to the pathology of the equine foot, if we take into account the increased activation of the dorsiflexors of the foot. OBJECTIVE: The main objective is to evaluate which of the techniques, percutaneous or transcutaneous, is more effective for the approach of clubfoot in post-stroke patients. METHODOLOGY: a clinical trial with randomized probabilistic assignment in four groups is proposed: G1 (percutaneous neuromodulation): patients will receive a needle circuit approaching the deep peroneal nerve in an ultrasound-guided manner. They will receive a 20-30Hz symmetrical biphasic current; G2 (transcutaneous neuromodulation): patients will have a superficial electrode circuit placed over the belly of the tibialis anterior muscle. They will receive a symmetrical biphasic current of 20-30Hz; G3 (placebo-percutaneous group): in which the patients will receive the neuromodulation circuit with needles at 0 intensity; G2 (placebo-transcutaneous group): the patients will receive the electrodes at 0 intensity over the belly of the tibialis anterior muscle. The variables to be analyzed are: anthropometric variables (age, weight, height, BMI), muscle oxygenation (SatO2, O2Hb, HHb and THb), muscle strength of the foot dorsiflexors measured with dynamometer, muscle activation by surface electromyography, active and passive joint balance with goniometry or inclinometer, assessment of gait and balance, assessment of load distribution by static and dynamic pressure platform, spasticity and questionnaire on quality of life and functionality. The acute effects after one intervention session (pre-post intervention of one session) and the effects after a 10-session program will be analyzed.

NO

Stroke/Brain Attack

DEVICE: Percutaneous neuromodulation|DEVICE: Transcutaneous neuromodulation|DEVICE: Placebo-percutaneous|DEVICE: Placebo-transcutaneous|DEVICE: Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)

Muscle activity, MDurance surface electromyography, 1 day|Displacement of the center of pressures (CoP), Postural stability: baropodometric platform, 1 day|Articular amplitude, Dorsal flexion using goniometer, 1 day|Balance, Timed Up and Go (TUG), 1 day|Balance, Tinetti scale: The test is divided into two parts, the assessment of balance on the one hand and gait on the other. To do this we will ask the patient different movements and activities that we will score from 0 to 2, depending on the section, being the maximum score in the balance 16 points and 12 points in the gait., 1 day|Gait, 10 minutes walking test, 1 day|Tissue oxygen in muscle, Oximeter. Moxy-3 in the thigh, 1 day|Muscular strength, Tibialis anterior strength by dynamometry, 1 day|Functionality, ECVI-38 scale (Quality of Life Scale for Stroke): 38 items hypothetically grouped into eight domains: physical state, communication, cognition, emotions, feelings, basic activities of daily living, common activities of daily living, and socio-familial functions.; plus two additional questions on sexual function and work activity., 1 day|quality of life index, ECVI-38 scale (Quality of Life Scale for Stroke): 38 items hypothetically grouped into eight domains: physical state, communication, cognition, emotions, feelings, basic activities of daily living, common activities of daily living, and socio-familial functions.; plus two additional questions on sexual function and work activity., 1 day|Spasticity, Ashworth scale: scale from 0 to 4. 0 means mild muscle tone and 4 means high hypertonicity., 1 day

University of Extremadura

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

160224

2024-02-16

2024-02-16

2024-04-30

2024-04-15

2024-04-15

Mª Dolores Apolo Arenas, Badajoz, Spain

{ "Percutaneous neuromodulation": [ { "intervention_type": "DEVICE" } ], "Transcutaneous neuromodulation": [ { "intervention_type": "DEVICE" } ], "Placebo-percutaneous": [ { "intervention_type": "DEVICE" } ], "Placebo-transcutaneous": [ { "intervention_type": "DEVICE" } ], "Percutaneous neuromodulation or Transcutaneous neuromodulation (optional)": [ { "intervention_type": "DEVICE" } ] }

NCT05546931

Mobile Health Program for Rural Hypertension

https://clinicaltrials.gov/study/NCT05546931

RECRUITING

Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).

NO

Hypertension,Essential|Adherence, Medication|Quality of Life

BEHAVIORAL: Coaching application|OTHER: WebMD|BEHAVIORAL: Home-based blood pressure monitoring

Change in systolic and diastolic blood pressure from baseline to 6 months, Change in home-based systolic and diastolic blood pressure from baseline to 6 months between the intervention and usual care arms., Baseline, 6 months

Adherence to antihypertensive medications, Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence., Baseline, 6 months|Adherence to antihypertensive medications, Adherence to antihypertensive medication from baseline to 12 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence., Baseline, 12 months|Patient-Reported Outcomes, Patient-reported outcomes between the intervention and usual care arms at 6 months measured with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) with distinct assessments of the following: (1) physical function, (2) anxiety, (3) depression, (4) fatigue, (5) sleep, (6) ability to participate in social roles, (7) social role satisfaction, and (8) interference in functioning by pain. Each domain is scored separately, such that scores for each domain range from 4 (lowest score) to 20 (highest score), where higher scores indicate greater impairment., Baseline, 6 months|Patient-Reported Outcomes, Patient-reported outcomes between the intervention and usual care arms at 12 months measured with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) with distinct assessments of the following: (1) physical function, (2) anxiety, (3) depression, (4) fatigue, (5) sleep, (6) ability to participate in social roles, (7) social role satisfaction, and (8) interference in functioning by pain. Each domain is scored separately, such that scores for each domain range from 4 (lowest score) to 20 (highest score), where higher scores indicate greater impairment., Baseline, 12 months|Self-efficacy for managing medications and treatment, Patient-reported outcomes between the intervention and usual care arms at 6 months measured with the Patient-Reported Outcomes Measurement Information System Self-efficacy for managing medications and treatment, a 10-item instrument, scored from 10 (minimum) to 40 (maximum), where higher scores indicate superior self-efficacy., Baseline, 6 months|Self-efficacy or managing medications and treatment, Patient-reported outcomes between the intervention and usual care arms at 12 months measured with the Patient-Reported Outcomes Measurement Information System Self-efficacy for managing medications and treatment, a 10-item instrument, scored from 10 (minimum) to 40 (maximum), where higher scores indicate superior self-efficacy., Baseline, 12 months

University of Pittsburgh

National Heart, Lung, and Blood Institute (NHLBI)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

STUDY21120151|R01HL160749

2023-09-04

2026-12

2027-06

2022-09-21

2024-05-08

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15213, United States

{ "Coaching application": [ { "intervention_type": "BEHAVIORAL" } ], "WebMD": [ { "intervention_type": "OTHER" } ], "Home-based blood pressure monitoring": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT02267031

The Role of Perioperative Ventilation (Gas Exchange) During Intrabdominal Surgery on Cognitive Function

https://clinicaltrials.gov/study/NCT02267031

ACDYS

COMPLETED

Abdominal surgery commonly requires perioperative relaxation and therefore controlled mechanical ventilation. However, respiratory support can be associated with minor, yet clinically significant changes in blood gas content. The inadvertent hyperoxia (excessively high oxygen) and/or hypocapnia (excessively low carbon dioxide) can result in transient changes in cerebral blood flow and cognitive impair.

NO

Response to Hyperoxia|Hypocapnia

PROCEDURE: mechanical ventilation

Cognitive function, Cognitive function will be assessed using Montreal Cognitive Assessment Score (MoCA), 36 hrs

Psychological Changes, Using developed phone query (memory, cognition, anxiety etc.), 6 months|Pain perception, Using Visual Analog Score (VAS), 6 hrs|Pain perception, Using Visual Analog Score (VAS), 36 hrs

Northern State Medical University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

AC-2012

2012-10

2016-08

2016-08

2014-10-17

2016-09-22

City hospital # 1 / Northern State Medical University,, Arkhangelsk, 163001, Russian Federation

{ "mechanical ventilation": [ { "intervention_type": "PROCEDURE" } ] }

NCT03226431

Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0

https://clinicaltrials.gov/study/NCT03226431

ARINA-1

COMPLETED

To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.

NO

Lung Transplant

DRUG: Ascorbic Acid

Changes in FEV1, Each individual s changes in pulmonary function will be assessed using the linear slope of FEV1 change from enrollment to the end of the treatment period., Baseline, 1 month, 3 months, 6 months, 12 months|Changes in FENO, Each individual s changes in FENO will be assessed using the change in mean baseline FENO measurements to the mean measurements post-ARINA-1 use., Baseline|Changes in Quality of Life, Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant., Baseline, 12 months

Duke University

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

Pro00080819

2017-12-11

2019-06-25

2019-06-25

2017-07-21

2019-07-05

Duke University Medical Center, Durham, North Carolina, 27710, United States

{ "Ascorbic acid": [ { "intervention_type": "DRUG", "description": "Ascorbic Acid", "name": "Ascorbic acid", "synonyms": [ "L-Ascorbic Acid", "Acidum ascorbicum", "Vitamina C", "\u00e1cido asc\u00f3rbico", "Ascorbate", "acidum ascorbinicum", "acide ascorbique", "L-(+)-ascorbic acid", "L-Ascorbate", "Ascorbic acid", "Ascorbins\u00e4ure" ], "drugbank_id": "DB00126", "generic_names": [ "Ascorbic acid" ] } ] }

NCT03664973

Serratus Plane Block for Rib Fractures

https://clinicaltrials.gov/study/NCT03664973

UNKNOWN

Patients with ipsilateral multiple rib fractures will be randomized to receive either a single-shot ultrasound-guided serratus plane block, or a continuous serratus plane block within 24h from the chest trauma. Primary outcome is the difference in forced respiratory volume (FEV1) at 72h.

NO

Chest Trauma|Chest Pain

PROCEDURE: Serratus plane block

Pulmonary change function, FEV 1, day 0 and day 3

Numerical rating scale (NRS) of pain, Pain both at rest and on movement on a 0-10 scale where 0 is the best and 10 the worst, day 0, day 1, day 2, day 3, day 4|Morphine, morphine requirement, day 0, day 1, day 2, day 3, day 4|hospital stay, time to fill the discharge criteria, day 1, day 2, day 3, day 4, day 5, day 6, day7

Arcispedale Santa Maria Nuova-IRCCS

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

Serratus GC

2018-09-03

2019-09

2019-10-03

2018-09-11

2019-05-09

AUSL IRCCS Reggio Emilia, Reggio Emilia, 42120, Italy

{ "Serratus plane block": [ { "intervention_type": "PROCEDURE" } ] }

NCT05089227

Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study

https://clinicaltrials.gov/study/NCT05089227

API-AHAI

RECRUITING

Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence <1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies. Apart from complications related to anemia, the occurrence of venous thromboembolism (VTE) in this population is frequent, estimated at 20-27%. The risk of VTE is highest during the period of hemolysis, especially during the first 3 months after the diagnosis of AIHA. This risk is 7.5 [4.7; 12.0] times greater than in the general population. No clinical predictive factor for VTE was identified and the usual factors (cancer, previous VTE, bed rest >3 days, surgery, age >70 years, heart or respiratory failure, myocardial infarction, stroke, obesity, hormone replacement therapy) were not considered. Several biological risk factors have been suggested (depth of anemia, bilirubin level, leukocyte count, antiphospholipid antibodies) but have not been confirmed in other studies. AIHA is therefore a risk factor for VTE in its own right, and the National Diagnostic and Care Protocol (NDCP) recommends the implementation of VTE prevention during acute hemolysis (Grade C). However, the value of this prophylaxis has never been prospectively evaluated and its duration is empirical. In practice, low-molecular-weight heparin (LMWH) is generally used during flare-ups of AIHA (diagnosis and relapse) in hospitalized patients, but is rarely continued beyond the hospital phase when VTE also occurs in ambulatory patients. Thus, we hypothesize that prolonged preventive anticoagulation during the 12-week risk period following diagnosis or relapse of AIHA could decrease the incidence of VTE. In orthopedic surgery, this strategy has been proven to decrease VTE from 50% to 10-15%. In certain high-risk medical situations, prolonged prophylaxis with apixaban has been shown to decrease the occurrence of VTE from 10.2% to 4.2% in solid cancers4 and from 4-11% to 2% in myeloma.

NO

Prolonged Anticoagulation|Venous Thromboembolic Disease|Autoimmune Hemolytic Anemia

DRUG: treatment intervention |DRUG: treatment standard |BIOLOGICAL: biological assessment

Occurrence of clinical venous thromboembolic events (deep vein thrombosis (DVT) and pulmonary embolism (PE)), defined by the presence of DVT confirmed by venous Doppler and/or PE confirmed by thoracic angioscan or ventilation/perfusion lung scintigraphy., 24 weeks after randomization

Centre Hospitalier Universitaire Dijon

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

AUDIA PHRCI 2019

2022-02-03

2025-08

2025-08

2021-10-22

2023-07-21

Chu Dijon Bourgogne, Dijon, 21000, France

{ "treatment intervention": [ { "intervention_type": "DRUG" } ], "treatment standard": [ { "intervention_type": "DRUG" } ], "biological assessment": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00449527

A Two-week Study Assessing the Onset of Effect Questionnaire (OEQ) Administered Daily Versus Weekly in Adult Subjects

https://clinicaltrials.gov/study/NCT00449527

COMPLETED

The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) using a 1 week recall period versus a 1 day recall period.

NO

Asthma

DRUG: Budesonide/formoterol pMDI|DRUG: Budesonide HFA pMDI

To demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) items 2 and 5 using a 1 week recall period versus a 1 day recall period.

To demonstrate the value to subjects of feeling an asthma maintenance medication begins to work right away; to assess the correlation between subject s responses to weekly/daily Onset of Effect Questionnaires with lung function and with diary variables.

AstraZeneca

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

D5896C00023

2007-03

2007-08

2007-03-20

2011-01-24

Research Site, Tuscumbia, Alabama, United States|Research Site, Fort Smith, Arkansas, United States|Research Site, Long Beach, California, United States|Research Site, Orange, California, United States|Research Site, Riverside, California, United States|Research Site, Sacramento, California, United States|Research Site, San Diego, California, United States|Research Site, San Jose, California, United States|Research Site, Colorado Springs, Colorado, United States|Research Site, Denver, Colorado, United States|Research Site, Valrico, Florida, United States|Research Site, River Forest, Illinois, United States|Research Site, Council Bluffs, Iowa, United States|Research Site, Topeka, Kansas, United States|Research Site, Wichita, Kansas, United States|Research Site, Bowling Green, Kentucky, United States|Research Site, Florence, Kentucky, United States|Research Site, Metairie, Louisiana, United States|Research Site, St. Louis, Missouri, United States|Research Site, St. Peters, Missouri, United States|Research Site, Butte, Montana, United States|Research Site, Omaha, Nebraska, United States|Research Site, Papillion, Nebraska, United States|Research Site, Las Vegas, Nevada, United States|Research Site, Skillman, New Jersey, United States|Research Site, Summit, New Jersey, United States|Research Site, Albuquerque, New Mexico, United States|Research Site, New York, New York, United States|Research Site, North Syracuse, New York, United States|Research Site, Rochester, New York, United States|Research Site, Greensboro, North Carolina, United States|Research Site, Mooresville, North Carolina, United States|Research Site, Oklahoma City, Oklahoma, United States|Research Site, Tulsa, Oklahoma, United States|Research Site, Collegeville, Pennsylvania, United States|Research Site, Charleston, South Carolina, United States|Research Site, Greenville, South Carolina, United States|Research Site, Spartanburg, South Carolina, United States|Research Site, Union, South Carolina, United States|Research Site, Dallas, Texas, United States|Research Site, South Burlington, Vermont, United States|Research Site, Bellingham, Washington, United States|Research Site, Spokane, Washington, United States|Research Site, Tacoma, Washington, United States

{ "Budesonide/formoterol": [ { "intervention_type": "DRUG", "description": "Budesonide/formoterol pMDI", "name": "Budesonide/formoterol", "synonyms": [ "BiResp Spiromax", "DuoResp Spiromax", "Budesonide/formoterol", "Symbicort" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Budesonide/formoterol", "generic_names": [] } ], "Budesonide": [ { "intervention_type": "DRUG", "description": "Budesonide HFA pMDI", "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" } ] }

NCT00005127

Muscatine Heart Study

https://clinicaltrials.gov/study/NCT00005127

COMPLETED

To conduct longitudinal and cross-sectional studies of risk factors for coronary heart disease and hypertension in school age children and adults who had been examined in previous screens.

NO

Cardiovascular Diseases|Coronary Disease|Hypertension|Heart Diseases

National Heart, Lung, and Blood Institute (NHLBI)

MALE

CHILD, ADULT, OLDER_ADULT

NIH

OBSERVATIONAL

Observational Model: |Time Perspective: p

906|P50HL014230

1971-06

1991-11

2000-05-26

2016-05-13

{}

NCT04080427

Effects of Delta9-tetrahydrocannabinol (THC) on Retention of Memory for Fear Extinction Learning in PTSD: R33 Study

https://clinicaltrials.gov/study/NCT04080427

RECRUITING

The goal of this study is to look at how a type of drug called cannabinoids are related to the processing of fear signals, the experience of emotions and fear, and the pattern of activity in the brain that is involved in these processes and how this relates to the treatment of post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder that occurs after experiencing a traumatic event(s) and is characterized by unwanted memories of the trauma(s) through flashbacks or nightmares, avoidance of situations that remind the person of the event, difficulty experiencing emotions, loss of interest in activities the person used to enjoy, and increased arousal, such as difficulty falling asleep or staying asleep, anger and hypervigilance. The information gained from this study could lead to the development of new treatments for persons who suffer from anxiety or fear-based disorders.

NO

Posttraumatic Stress Disorder

DRUG: Placebo capsule|DRUG: Dronabinol 7.5 milligram oral capsule

Brain Measures, functional magnetic resonance imaging (fMRI) blood oxygen level-dependent (BOLD) percent signal change within region of interests [amygdala; ventromedial prefrontal cortex; hippocampus], Through study completion, an average of 3 months.|Psychophysiology, Skin conductance response (SCR): change in SCR [peak amplitude from 0.5-4.5 sec following stimulus presentation minus average 2 second baseline prior to stimulus presentation]., Through study completion, an average of 3 months.|Expectancy Ratings, To assess the change in expected likelihood that an aversive cue (e.g. noise burst or shock) will occur or not based on while slide was shown, participants will repeatedly rate their expectancy of the aversive cue using a button box on a scale from 1 to 3 [1 = certain that the aversive cue will be presented; 2 = certain that the aversive cue will not be presented; 3 = uncertain whether the aversive cue will be presented]., Through study completion, an average of 3 months.|PTSD Checklist (PCL-5), To track PTSD symptom change for each participant. The PCL-5 is a 20-item questionnaire. The self-report rating scale is 0-4 for each symptom: Not at all, A little bit, Moderately, Quite a bit, and Extremely , respectively. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items., Through study completion, an average of 3 months.|Clinician Administered PTSD Scale for Diagnostic and Statistical Manual (DSM)-5 (CAPS-5), To track PTSD symptom change for each participant. The CAPS is the gold standard in PTSD assessment. The CAPS is a 30-item structured interview. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype. The assessor combines information about frequency and intensity of an item into a single severity rating. Total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. The five-point CAPS-5 symptom severity rating scale is used for all symptoms (0, Absent; 1, mild; 2, Moderate/threshold; 3, Severe/markedly elevated; 4, Extreme/incapacitating). Total CAPS-5 symptom severity scores range from 0-80, with higher scores indicating worse PTSD symptom severity., Through study completion, an average of 3 months.|Subjective Units of Distress Scale (SUDS), To assess the change in level of distress from 0 to 100 when facing fears. The higher the number on the scale the more severe the level of distress experienced., Through study completion, an average of 3 months.

Visual Analogue Scale of Mood (VAS), Subjective ratings of mood and drug effects on a 0-100. Higher numbers on the scale reflect stronger experiences of different mood and drug effects. Each item is scored individually. There is no overall score., Through study completion, an average of 3 months.|Drug Effects Questionnaire (DEQ), Subjective ratings of drug effects on from 1-5 on the following scales: Feel , High , and Like ., Through study completion, an average of 3 months.|Addiction Research Center Inventory (ARCI), A standardized questionnaire of 53 statements for assessing subjective effects of psychoactive drugs. Used to differentiate drug effects from placebo. Participants rate true if the statement applies to them or false if it does not apply. Specific statements are related to a particular drug class and for that drug class all true responses are summed for a total score in that drug class. Higher scores means higher subjective drug effects for particular drug classes. The scales are the Morphine-Benzedrine (score range: 0-16; drug-induced euphoria), Amphetamine (score range: 0-11; specific for dose-related effects of d-amphetamine), Benzedrine (score range: 0-13; an amphetamine scale relating to intellectual efficiency and energy); Pentobarbital-Chlorpromazine (score range: 0-15; sedation); Lysergic Acid (score range: 0-13; dysphoria and somatic symptoms); and Marijuana (score range: 0-12; marijuana s effects)., Through study completion, an average of 3 months.|State-Trait Anxiety Inventory (STAI), Measures of state and trait anxiety. The STAI has 20 items for assessing trait anxiety and 20 for state anxiety. State anxiety items include: I am tense; I am worried and I feel calm; I feel secure. Trait anxiety items include: I worry too much over something that really doesn t matter and I am content; I am a steady person. All items are rated on a 4-point scale (e.g., from Almost Never to Almost Always ). The numerical ratings for each of the 20 items assessing trait anxiety are summed for a total trait anxiety score. The numerical ratings for each of the 20 items assessing state anxiety are summed for a total state anxiety score. Scores on the trait and state anxiety scales of the STAI can range from 20-80. STAI scores are commonly classified as no or low anxiety (scores 20-37), moderate anxiety (scores 38-44), and high anxiety (scores 45-80)., Through study completion, an average of 3 months.|End of Session Questionnaire (ESQ), Includes 5 questions total. The first two question ask the participant to select one of several statements that best describes the effect of the capsule they took during that visit. The second question asks the participant to guess what they thought they received in the capsule and how confident they are. The third question asks the participant to rate how much the liked or disliked the effects of the capsule overall on a scale from -5 to 5, with -5 being disliked a lot , 0 being neutral , and 5 being liked a lot . The fourth question asks participants to check yes or no if they would take the capsule again. Finally, the last question is a free text response asking the participant if they experienced any unusual reactions or if they have any comments or observations that may be relevant to the study., Through study completion, an average of 3 months.|Heart Rate, Heart rate, Through study completion, an average of 3 months.|Blood Pressure, Systolic and diastolic blood pressure will be assessed., Through study completion, an average of 3 months.

Wayne State University

National Institute of Mental Health (NIMH)

ALL

ADULT

PHASE1

OTHER

INTERVENTIONAL

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

R33MH111935|R61MH111935

2021-04-15

2024-12-31

2025-12-31

2019-09-06

2023-07-14

Eugene Applebaum College of Pharmacy and Health Sciences, Detroit, Michigan, 48201, United States

{ "Placebo capsule": [ { "intervention_type": "DRUG" } ], "Dronabinol": [ { "intervention_type": "DRUG", "description": "Dronabinol 7.5 milligram oral capsule", "name": "Dronabinol", "synonyms": [ "delta(1)-THC", ".DELTA.1-THC", "3-Pentyl-6,6,9-trimethyl-6a,7,8,10a-tetrahydro-6H-dibenzo(b,d)pyran-1-ol", "(-)-delta9-trans-Tetrahydrocannabinol", "THC", "Tetrahydrocannabinol, (6a-trans)-Isomer", "9-ene-Tetrahydrocannabinol", "Tetrahydrocannabinol, (6aR-cis)-Isomer", "Tetrahydrocannabinol, Trans-Isomer", "delta(9)-THC", "Tetrahydrocannabinol, Trans-(+-)-Isomer", "Delta-9-tetrahydrocannabinol", "Marinol", "1-trans-delta-9-Tetrahydrocannabinol", "\u03949-tetrahydrocannabinol", "Tetrahydrocannabinol, (6aS-cis)-Isomer", "delta9-tetrahydrocannabinol", "9 ene Tetrahydrocannabinol", "delta-9-THC", "6,6,9-Trimethyl-3-pentyl-6a,7,8,10a-tetrahydro-6H-benzo[c]chromen-1-ol", "Dronabinol", "Tetrahydrocannabinol, Trans Isomer", "Dronabinolum", "Tetrahydrocannabinol", "delta(1)-Tetrahydrocannabinol", "delta-9-tetrahydrocannabinol", "delta(1)-tetrahydrocannabinol", "delta(9)-Tetrahydrocannabinol" ], "medline_plus_id": "a607054", "generic_names": [ "Dronabinol" ], "mesh_id": "D063386", "drugbank_id": "DB00470" } ] }

NCT02679573

Study to Compare Delafloxacin to Moxifloxacin for the Treatment of Adults With Community-acquired Bacterial Pneumonia

https://clinicaltrials.gov/study/NCT02679573

DEFINE-CABP

COMPLETED

The purpose of this study is to evaluate the safety and efficacy of delafloxacin compared to moxifloxacin in the treatment of adult patients with community-acquired pneumonia.

YES

Community Acquired Bacterial Pneumonia

DRUG: Delafloxacin|DRUG: Moxifloxacin|DRUG: Linezolid

Early Clinical Response, Early clinical response defined as improvement in at least 2 of the following symptoms (as assessed by the investigator): chest pain, frequency or severity of cough, amount and quality of productive sputum, and difficulty breathing, and no worsening of the other symptoms in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline., 96 (+/- 24) hours after the first dose of study drug

Early Clinical Response Plus Improvement in Vital Signs and no Worsening of the 4 Symptoms, Early clinical response with the addition of improvement in vital signs and no worsening of the following 4 symptoms: chest pain, cough, productive sputum, and difficulty breathing in the ITT population. Symptom severity evaluated by the investigator on a 4-point scale: Absent (0), Mild (1), Moderate (2), Severe (3). Improvement defined as at least a 1-point decrease from baseline. Improvement in vital signs defined as a return to normal of any abnormal vital signs at baseline, and no worsening (ie, be abnormal) of any vital sign that was normal at baseline., 96 (+/- 24) hours after the first dose of study drug|Clinical Outcome at Test of Cure, Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator s assessment of the patient s signs and symptoms of infection in the ITT population., 5 to 10 days after the last dose of study drug|Clinical Outcome at End of Treatment, Clinical outcome (Success, Failure, or Indeterminate/missing) based on the investigator s assessment of the patient s signs and symptoms of infection in the ITT population., Up to 24 (+4) hours after the last dose of study drug|Microbiologic Response, Microbiological response for subjects in the MITT set will be based on results of the baseline and follow-up cultures and susceptibility testing or serology., 5 to 10 days after the last dose of study drug|All-cause Mortality, Time to all-cause Mortality was assessed on Day 28., Day 28 (+/- 2 days)

Melinta Therapeutics, Inc.

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

ML-3341-306|2015-003026-14

2016-12-14

2018-07-31

2018-08-07

2016-02-10

2020-02-27

2020-02-27

Melinta 306 Study Site, Montgomery, Alabama, 36106, United States|Melinta 306 Study Site, Newark, Delaware, 19718, United States|Melinta 306 Study Site, Coral Gables, Florida, 33134, United States|Melinta 306 Study Site, DeBary, Florida, 32713, United States|Melinta 306 Study Site, DeLand, Florida, 32720, United States|Melinta 306 Study Site, Fort Myers, Florida, 33901, United States|Melinta 306 Study Site, Miami, Florida, 33126, United States|Melinta 306 Study Site, Miami, Florida, 33185, United States|Melinta 306 Study Site, Louisville, Kentucky, 40202, United States|Melinta 306 Study Site, Natchitoches, Louisiana, 71457-6215, United States|Melinta 306 Study Site, Baltimore, Maryland, 21201, United States|Melinta 306 Study Site, Boston, Massachusetts, 02115, United States|Melinta 306 Study Site, Burlington, Massachusetts, 01805, United States|Melinta 306 Study Site, Saint Paul, Minnesota, 55104, United States|Melinta 306 Study Site, Saint Louis, Missouri, 63110, United States|Melinta 306 Study Site, Butte, Montana, 59701, United States|Melinta 306 Study Site, Omaha, Nebraska, 68124, United States|Melinta 306 Study Site, Newark, New Jersey, 07102, United States|Melinta 306 Study Site, Buffalo, New York, 14215, United States|Melinta 306 Study Site, Charlotte, North Carolina, 28203, United States|Melinta 306 Study Site, Cleveland, Ohio, 44106-5029, United States|Melinta 306 Study Site, Dayton, Ohio, 45402, United States|Melinta 306 Study Site, Rapid City, South Dakota, 57702, United States|Melinta 306 Study Site, Franklin, Tennessee, 37067, United States|Melinta 306 Study Site, Corsicana, Texas, 75110, United States|Melinta 306 Study Site, Buenos Aires, Argentina|Melinta 306 Study Site, Córdoba, Argentina|Melinta 306 Study Site, La Plata, Argentina|Melinta 306 Study Site, Pleven, Bulgaria|Melinta 306 Study Site, Ruse, Bulgaria|Melinta 306 Study Site, Sofia, Bulgaria|Melinta 306 Study Site, Stara Zagora, Bulgaria|Melinta 306 Study Site, Barranquilla, Colombia|Melinta 306 Study Site, Cali, Colombia|Melinta 306 Study Site, Manizales, Colombia|Melinta 306 Study Site, Medellín, Colombia|Melinta 306 Study Site, Quindío, Colombia|Melinta 306 Study Site, Santo Domingo, Dominican Republic|Melinta 306 Study Site, Tbilisi, Georgia|Melinta 306 Study Site, Leverkusen, Germany|Melinta 306 Study Site, Munich, Germany|Melinta 306 Study Site, Budapest, Hungary|Melinta 306 Study Site, Debrecen, Hungary|Melinta 306 Study Site, Deszk, Hungary|Melinta 306 Study Site, Miskolc, Hungary|Melinta 306 Study Site, Nyíregyháza, Hungary|Melinta 306 Study Site, Szombathely, Hungary|Melinta 306 Study Site, Daugavpils, Latvia|Melinta 306 Study Site, Liepaja, Latvia|Melinta 306 Study Site, Riga, Latvia|Melinta 306 Study Site, Lima, Peru|Melinta 306 Study Site, Chrzanow, Poland|Melinta 306 Study Site, Katowice, Poland|Melinta 306 Study Site, Lodz, Poland|Melinta 306 Study Site, Wroclaw, Poland|Melinta 306 Study Site, Braşov, Romania|Melinta 306 Study Site, Bucharest, Romania|Melinta 306 Study Site, Craiova, Romania|Melinta 306 Study Site, Timisoara, Romania|Melinta 306 Study Site, Arkhangel sk, Russian Federation|Melinta 306 Study Site, Moscow, Russian Federation|Melinta 306 Study Site, Smolensk, Russian Federation|Melinta 306 Study Site, St. Petersburg, Russian Federation|Melinta 306 Study Site, Vsevolozhsk, Russian Federation|Melinta 306 Study Site, Belgrade, Serbia|Melinta 306 Study Site, Kragujevac, Serbia|Melinta 306 Study Site, Nis, Serbia|Melinta 306 Study Site, Sremska Kamenica, Serbia|Melinta 306 Study Site, Golnik, Slovenia|Melinta 306 Study Site, Ljubljana, Slovenia|Melinta 306 Study Site, Benoni, South Africa|Melinta 306 Study Site, Chatsworth, South Africa|Melinta 306 Study Site, Krugersdorp, South Africa|Melinta 306 Study Site, Middelburg, South Africa|Melinta 306 Study Site, Phoenix, South Africa|Melinta 306 Study Site, Port Elizabeth, South Africa|Melinta 306 Study Site, Pretoria, South Africa|Melinta 306 Study Site, Worcester, South Africa|Melinta 306 Study Site, Badalona, Spain|Melinta 306 Study Site, Barcelona, Spain|Melinta 306 Study Site, Madrid, Spain|Melinta 306 Study Site, Terrassa, Spain|Melinta 306 Study Site, Valencia, Spain|Melinta 306 Study Site, Dnipro, Ukraine|Melinta 306 Study Site, Kharkiv, Ukraine|Melinta 306 Study Site, Kyiv, Ukraine|Melinta 306 Study Site, Poltava, Ukraine|Melinta 306 Study Site, Vinnytsia, Ukraine|Melinta 306 Study Site, Zaporizhia, Ukraine|Melinta 306 Study Site, Zhytomyr, Ukraine

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT02679573/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT02679573/SAP_001.pdf

{ "Delafloxacin": [ { "intervention_type": "DRUG", "description": "Delafloxacin", "name": "Delafloxacin", "synonyms": [ "Delafloxacin", "Baxdela", "Quofenix" ], "medline_plus_id": "a617047", "generic_names": [ "Delafloxacin" ], "drugbank_id": "DB11943", "wikipedia_url": "https://en.wikipedia.org/wiki/Delafloxacin" } ], "Moxifloxacin": [ { "intervention_type": "DRUG", "description": "Moxifloxacin", "name": "Moxifloxacin", "synonyms": [ "Izilox", "Avalox", "Moxifloxacin", "Actira", "Moxifloxacin Hydrochloride", "BAY 12 8039", "Moxifloxacino", "BAY-128039", "BAY 12-8039", "Avelox", "BAY128039", "Octegra", "1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4as,7as)-octahydro-6H-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid", "Proflox", "1-Cyclopropyl--7-(2,8-diazabicyclo(4.3.0)non-8-yl)-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid", "BAY-12-8039", "Moxeza", "BAY 128039" ], "medline_plus_id": "a605016", "generic_names": [ "Moxifloxacin" ], "mesh_id": "D059005", "drugbank_id": "DB00218" } ], "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" } ] }

NCT03854773

Erector Spinae Plane Block and Thoracal Paravertebral Block Following Video Assisted Thoracic Surgery

https://clinicaltrials.gov/study/NCT03854773

COMPLETED

Video assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. Analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. The ultrasound (US) guided erector spina plane (ESP) block is a novel interfacial plan block defined by Forero et al. at 2016. ESP block provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. Visualization of sonoanatomy with US is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle (12). Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, there is not still any randomized study evaluating ESP block efficiency for postoperative analgesia management after VATS. The aim of this study is to compare US-guided ESP block and TPVB for postoperative analgesia management after VATS.

NO

Lung Diseases

OTHER: Erector spinae plane block (Group ESPB)|OTHER: Thoracal paravertebral block (Group TPVB)|OTHER: Control group (group C)

opioid consumption, The primary aim is to compare perioperative and postoperative opioid consumption, Change from Baseline Postoperative Visual Analogue Score at 48 hours

Visual analogue scores (VAS), Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16 and 24 hours., postoperative 1, 2, 4, 8, 16, 24, and 48 hours

Medipol University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

MedipolU

2019-03-01

2020-05-01

2020-05-01

2019-02-26

2020-05-12

Istanbul Medipol University Hospital, Istanbul, Bagcilar, 34070, Turkey

{ "Erector spinae plane block (Group ESPB)": [ { "intervention_type": "OTHER" } ], "Thoracal paravertebral block (Group TPVB)": [ { "intervention_type": "OTHER" } ], "Control group (group C)": [ { "intervention_type": "OTHER" } ] }

NCT00188773

Mechanism of Fatty Acid-Induced Impairment of Glucose-Stimulated Insulin Secretion

https://clinicaltrials.gov/study/NCT00188773

COMPLETED

A prolonged elevation of plasma free fatty acids (FFA) impairs glucose stimulated insulin secretion. The concept of fatty acid impairment of glucose stimulated insulin secretion (lipotoxicity) has now been well accepted. Increased free fatty acid flux from adipose tissue to non-adipose tissue, resulting from abnormalities of fat metabolism, participates in and amplifies many of the metabolic derangements that are characteristic of insulin resistance syndrome and type 2 diabetes. Lipotoxicity is also likely to play an important role in the progression from normal glucose tolerance to fasting hyperglycemia and conversion to frank type 2 diabetes in insulin resistant individuals. This area of research is now focused on determining the mechanisms whereby FFAs impair b-cell function. There is some evidence to suggest that lipotoxicity could be mediated through induction of reactive oxygen species (ROS). N-acetylcysteine (NAC) is a known potent antioxidant and has been used experimentally in a number of medical conditions in humans for its protective antioxidant effects. The investigators now plan to administer NAC orally to humans for 48 hours to examine the effects of antioxidant therapy in ameliorating the deleterious effects of FFAs on pancreatic beta cell function. NAC is currently approved for the treatment of acetaminophen overdose and is also used as a mucolytic agent. The investigators are now using NAC as an antioxidant to determine whether it protects the pancreatic beta cell against the toxic effects of FFAs, as outlined in the detailed study protocol. This is a proof-of-principle study and is not designed to develop n-acetylcysteine for therapeutic use.

NO

Insulin Resistance Syndrome X|Pancreatic Beta Cell Function

DRUG: N-acetylcysteine, intralipid, heparin

To determine whether the FFA-induced impairment of pancreatic b-cell function can be ameliorated or prevented by administration of the antioxidant, NAC, 2 years|Assessment of insulin sensitivity, 2 years|To determine whether administration of NAC, an antioxidant, prevents FFA-mediated impairment of GSIS in healthy humans., 2 years

assessment of glucose stimulated insulin secretion, 2 years

University Health Network, Toronto

MALE

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

03-0871-A|CDA Grant 777508221

2004-01

2007-08

2008-01

2005-09-16

2008-06-05

University Health Network, Toronto, Ontario, M5G 2C4, Canada

{ "N-acetylcysteine, intralipid, heparin": [ { "intervention_type": "DRUG" } ] }

NCT00004573

Kinetics of Response of Cytomegalovirus With Ganciclovir Treatment Using Quantitative Real-Time PCR

https://clinicaltrials.gov/study/NCT00004573

UNKNOWN

The overall purpose of this research is to develop and use a blood test to better understand how quickly the viral drug ganciclovir works to clear infection with the CMV virus (Cytomegalovirus) when it occurs. This test will potentially let doctors know early in the course of therapy when a virus is not responding well to the therapy and could therefore be resistant to the drug. The target population of this study will be primarily kidney and lung transplant patients with CMV detected in the blood, although other patients may also be included if they meet criteria. The study will be divided into two phases. Phase I will evaluate a small number of exploratory patients initiating ganciclovir therapy and will require frequent blood sampling to obtain detailed information regarding the kinetic response of the virus to therapy. This information will be analyzed to help guide decisions regarding the number and frequency of blood samples needed in the larger phase II portion of the study. Strains will be characterized using phenotypic and genotypic methods to determine the presence or absence of mutations potentially responsible for the resistance.

NO

Cytomegalovirus Infections

DRUG: ganciclovir

National Center for Research Resources (NCRR)

ALL

ADULT, OLDER_ADULT

NIH

INTERVENTIONAL

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

NCRR-M01RR00036-0728|M01RR000036

2000-02-21

2005-06-24

Infectious Diseases Division, St. Louis, Missouri, 63110, United States

{ "Ganciclovir": [ { "intervention_type": "DRUG", "description": "ganciclovir", "name": "Ganciclovir", "synonyms": [ "Ganciclovir, Monosodium Salt", "Nordeoxyguanosine", "Zirgan", "BW-759", "Nordexoyguanosine", "9-[(1,3-dihydroxy-2-propoxy)methyl]guanine", "2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-1H-purin-6(9H)-one", "2-amino-9-(2-hydroxy-1-hydroxymethylethoxymethyl)-6,9-dihydro-1H-6-purinone", "2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-9H-purin-6-ol", "GA2", "9-((2-Hydroxy-1-(hydroxymethyl)ethoxy)methyl)guanine", "2-amino-9-((1,3-dihydroxypropan-2-yloxy)methyl)-3H-purin-6(9H)-one", "Ganciclovirum", "Ganciclovir Sodium", "Ganciclovir", "2-Amino-9-(2-hydroxy-1-hydroxymethyl-ethoxymethyl)-1,9-dihydro-purin-6-one", "2-(6-Amino-purin-9-ylmethoxy)-propane-1,3-diol", "Cytovene", "GCV Sodium", "Gancyclovir", "BIOLF-62", "RS-21592" ], "medline_plus_id": "a620012", "generic_names": [ "Ganciclovir" ], "mesh_id": "D000998", "drugbank_id": "DB01004" } ] }

NCT00001873

The Role of Cyclosporine in Blood Cell Transplants With T-Cell Add-Back for Blood Cancers

https://clinicaltrials.gov/study/NCT00001873

COMPLETED

Cancers of the blood, sometimes referred to as hematologic malignancies, are disorders of bone marrow cells that lead to the failure of the normal function of bone marrow and the uncontrolled growth of cancerous cells in the bone marrow. These cancerous cells can spill over into the bloodstream and affect other organs causing widespread symptoms. The disease is life threatening because it blocks the normal function of the marrow, which is to produce red cells (preventing anemia), white cells (preventing infection), and platelets (preventing progression). Bone marrow transplants are a potential form of therapy for patients with hematologic malignancies. However, BMT is a complicated procedure and can be associated with dangerous side effects. In this study researchers are attempting to find ways to reduce the complications of BMT, so that it would be possible to use it more safely and can be offered more patients. In order to do this, researchers are developing new techniques to make BMT safer. It requires making small changes to the standard procedure, which may improve the outcome. The experimental procedures researchers are evaluating are: 1. <TAB>T-cell depleted peripheral blood progenitor cell (PBPC) transplantation 2. <TAB> Cyclosporine given immediately after the transplant 3. <TAB>Add-back of donor lymphocytes Patients undergoing these experimental techniques must be monitored closely to see if any benefit or harmful effects will occur. Information gathered from this study can be used to develop further research studies and potential new therapies for hematologic malignancies.

NO

Chronic Lymphocytic Leukemia|Graft vs Host Disease|Hematologic Neoplasm|Multiple Myeloma|Myelodysplastic Syndrome

DEVICE: Isolex 300i plus MoAbs

The proportion of patients with clinically significant acute GHVD (Grade II or higher) following the T depleted PBPC transplant (and before D45 add-back)., Day 45

National Heart, Lung, and Blood Institute (NHLBI)

ALL

CHILD, ADULT

PHASE2

NIH

INTERVENTIONAL

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

990046|99-H-0046

1999-02-22

2007-12-28

2017-06-13

1999-11-04

2018-09-26

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, 20892, United States

{ "Isolex 300i plus MoAbs": [ { "intervention_type": "DEVICE" } ] }

NCT04624373

Genotyping of Ebus-tbna Supernant Cell-free Dna in Nsclc

https://clinicaltrials.gov/study/NCT04624373

CELTICS

UNKNOWN

The wide uptake of liquid biopsy diagnostics in the care of advanced cancer patients highlights the desire for improved access to tumor allowing accurate tumor genotyping (1). Genotyping of plasma cfDNA is now routine for detection of EGFR driver mutations at diagnosis of NSCLC, or for detection of the EGFR T790M mutation after TKI resistance, and is an emerging approach for the detection of other drivers (HER2 or BRAF mutations, ALK or ROS1 fusions...) (2) or the estimation of tumor mutation burden (TMB) (3). However, the most sensitive plasma genotyping platforms still have a sensitivity of only 70%-80%, such that a negative result requires tissue biopsy confirmation.

NO

Lung Cancer

OTHER: Molecular analysis of surnatant

main aim of the study, to investigate the sensitivity of sfDNA genotyping in various clinical settings and to compare it to cell block, 18 months

TMB estimation, To assess the feasibility of TMB estimation on this specimen, 18 months|sensitivity of plasma, To compare the sensitivity of plasma genotyping to cell block, 18 months|concordance between plasma and supernatant, To investigate the concordance between plasma and supernatant for mutation detection and TMB estimation, 18 months|mutation rate, To calculate the rate of patients with at least one additional mutation detected on supernatant compared to cell block, 18 months|Sensitivity of supernatant and plasma, To compare the sensitivity of supernatant and plasma to cell block for the detection of specific alterations (EGFR, HER2, BRAF, PIK3CA, KRAS, MET mutations, ALK, ROS1, NTRK, RET fusions), 18 months|Turnaround time of supernatant, To compare the turnaround time of supernatant, plasma and cell block for genotyping, 18 months

University Hospital, Toulouse

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

RC31/19/0090

2022-12-31

2022-12-31

2022-12-31

2020-11-10

2020-11-10

Nicolas Guibert, Toulouse, France

{ "Molecular analysis of surnatant": [ { "intervention_type": "OTHER" } ] }

NCT04710173

Establishment of a Early Risk Model of ECMO in Children With ARDS

https://clinicaltrials.gov/study/NCT04710173

COMPLETED

The key problem in the treatment of ARDS is refractory hypoxemia. Extracorporeal Membrane Oxygenation (ECMO) is an extracorporeal oxygenation of venous blood to eliminate carbon dioxide and return to the body. It has been an important part of the rescue treatment for ARDS. This study intends to explore the timing of ECMO. The main research hypothesis is that the appropriate timing of ECMO treatment can improve the weaning success rate and survival rate of children with severe ARDS; it is expected to provide a basis for determining the best timing of ECMO treatment

NO

ARDS

PROCEDURE: ECMO

Survival rate, The survival rate of children in 28 days after hospital discharge, 28 days after hospital discharge

ECMO weaning rate, The success of ECMO weaning is defined as the survival of patients after ECMO weaning for 48 hours, 48 hours after ECMO weaning

Children s Hospital of Fudan University

The Children s Hospital of Zhejiang University School of Medicine|Children s Hospital of Chongqing Medical University|Guangdong Provincial People s Hospital|Chinese PLA General Hospital

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

fdpicu-07

2018-01-01

2022-12-30

2022-12-30

2021-01-14

2024-02-07

Chinese PLA General Hospital, Beijing, China|Children s Hospital of Chongqing Medical University, Chongqing, China|Guangdong Provincial People s Hospital, Guanzhou, China

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

NCT06472973

ADDICTOlogical Intervention in LIVEr Transplantation Recipients

https://clinicaltrials.gov/study/NCT06472973

AddictoLIVE

NOT_YET_RECRUITING

Transplantation for end-stage-liver disease (ESLD) in the context of Alcohol-Associated Liver Disease (AALD) has been increasing and represents the main indication for Liver Transplantation (LT) in the world. Alcohol Use Disorder (AUD) is considered a brain chronic disease and requires a transdisciplinary approach that includes medical treatment and behavioral interventions. In the context of LT, alcohol relapse occurs in 26 % up to 50% of LT recipients. Among Liver transplant recipients for AALD, severe alcoholic relapse (defined as more than 3 alcoholic drinks per day for women and 4/day for men) after LT leads to impaired longterm survival due to recurrent alcoholic cirrhosis (RAC), cardiovascular events and de novo cancer. Several strategies have been developed to prevent alcohol relapse. After LT, integrating an addiction team into the LT program has been advocated by the latest guidelines in Europe and the United States, in order to bring the management of alcohol-use disorder (AUD) in transplantation units, through the association of psychosocial and pharmacological interventions previously reported in AALD. However, those guidelines were based on descriptive studies, and the effect of this management needs to be confirmed through a randomized, controlled, multicenter study, involving centers that still do not include an addiction team in their LT programs. This study will therefore assess prospectively and comparatively the impact of an addiction intervention after LT on return to alcohol use rates. We hypothesize that standardized targeted addiction monitoring of Liver Transplant recipients decreases the rates of alcohol relapse two years post-liver transplantation.

NO

Alcohol Associated Liver Disease|Liver Transplantation

OTHER: Post-transplant addiction intervention

Time to return to alcohol use, Time to return to alcohol use is defined by the time between discharge from Liver Transplantation (LT) hospitalization and alcohol relapse,it includes either: * Severe relapse: alcohol intake of at least 4 units per day for men and 3 per day for women for at least 100 days; * Regular relapse: no more than 21 units a week for men, 14 units a week for women, at least 10 times a month; Alcohol consumption will be collected using the alcohol timeline follow back (TLFB), the assessor will be blinded to the participant s arm allocation. TLFB is a calandar used to asses the participant s alcohol intake, it evaluates their daily drinking and provides a report of their drinking pattern over a given time period. The first TLFB assessment will be carried out one month after discharge from LT hospitalization, then every 2 months up to 2 years after discharge from LT hospitalization., During 2 years after discharge from Liver transplantation hospitalization

Return to alcohol use of the slip type, Alcohol use will be measured using the TLFB,the assessor will be blinded to the participant s arm allocation. Slip type is defined by a unique excessive alcohol consumption (more than 4 alcohol drinks on a single occasion). The first TLFB assessment will be carried out one month after discharge from LT hospitalization, then every 2 months up to 2 years after discharge from LT hospitalization., During 2 years after discharge from Liver transplantation hospitalization|Tobacco use, Tobacco use will be measured by relative reduction in the number of cigarettes smoked per day compared with baseline, and by smoking abstinence at 24 months after discharge from LT hospitalization, for at least one month. Tobacco use will be self reported by the participant during interviews with an assessor who is blinded to their arm allocation. Tobacco use assessment will be carried out one month after discharge from LT hospitalization, then every 2 months up to 2 years after discharge from LT hospitalization., During 2 years after discharge from Liver transplantation hospitalization|Other psychoactive substances use, Psychoactive substances use (opiates, abuse drugs, psychostimulants or psychedelics ) will be self reported by the participant during interviews with an assessor who is blinded to their arm allocation. Psychoactive substances use assessment will be carried out one month after discharge from LT hospitalization, then every 2 months up to 2 years after discharge from LT hospitalization., During 2 years after discharge from Liver transplantation hospitalization|Addiction therapies, Addiction therapies (behavioral, motivational therapy and medication) implemented in the intervention arm will be described., During 2 years after discharge from Liver transplantation hospitalization|Major significant clinical events, Major significant clinical events includes death, cardiovascular events (myocardial infarction, pulmonary embolism, stroke), De Novo cancer and graft rejection. The occurrence of major significant clinical events will be collected during the participation period, time-to-event is defined as the time from LT until event or loss to follow-up or end of the study or death., During 2 years after discharge from Liver transplantation hospitalization|Biochemical liver tests, Biochemical liver tests ( Alanine transaminase ALT, Aspartate transaminase AST, gamma-glutamyl transferase GGT, alkaline phosphatase and bilirubin) evolution will be assessed. Biochemical liver tests will be measured as X upper limit normal ULN, 3 months after discharge from LT hospitalization, then every 2 months up to 2 years after discharge from LT hospitalization., During 2 years after discharge from Liver transplantation hospitalization|Alcohol consumption biomarker ethanol/Peth), Alcohol use biomarker (Phosphatidylethanol/Peth) kinetics, tested 3 times a year, will be compared to self-reported alcohol consumption. Blood phosphatidylethanol concentration is determined by liquid chromatography coupled to a tandem mass spectrometer., At 1 month, 11 or 13 months and at 24 months after discharge from Liver transplantation hospitalization|Liver fibrosis, Liver fibrosis will be assessed using liver stiffness measurement by pulse elastometry (Fibroscan) and expressed in kilopascal (kPa)., 2 years after discharge from Liver transplantation hospitalization|Evolution of cognitive disorders, Cognitive disorders will be measured using the Montreal Cognitive Assessment (MoCA) test which is a screening tool used to determine if there is any impairment in the participant s cognitive function, including their ability to understand, reason, and remember. The MoCA score ranges from 0 to 30: * 27-30: is considered normal * 18-26: indicates the presence of mild cognitive impairment * 10-17: indicates the presence of moderate cognitive impairment * < 10: indicates the presence of severe cognitive impairment MoCA test will be carried out at inclusion, 3 months after discharge from LT hospitalization then every 2 months up to 2 years after discharge from LT hospitalization., During 2 years after discharge from Liver transplantation hospitalization|Mortality and alcohol-associated mortality rate, The occurrence of death (overall mortality and alcohol-associated mortality) will be collected during the participation period. Time-to-death is defined as the time from LT until death., During 2 years after discharge from Liver transplantation hospitalization

University Hospital, Montpellier

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

RECHMPL23_0399

2024-09

2026-09

2028-09

2024-06-25

2024-06-25

Besançon University Hospital, Besançon, France|Bordeaux University Hospital, Bordeaux, France|Clermont Ferrand University Hospital, Clermont-Ferrand, France|Grenoble University Hospital, Grenoble, France|Lille University Hospital, Lille, France|Lyon University Hospital, Lyon, France|Marseille University Hospital, Marseille, France|Montpellier University Hospital, Montpellier, 34000, France|Nice University Hospital, Nice, France|APHP Mondor, Paris, France|APHP Paul Brousse, Paris, France|APHP Salpetrière, Paris, France|Rennes University Hospital, Rennes, France|Strasbourg University Hospital, Strasbourg, France|Toulouse University Hospital, Toulouse, France|Tours University Hospital, Tours, France

{ "Post-transplant addiction intervention": [ { "intervention_type": "OTHER" } ] }

NCT06186973

Fetal Assessment of the Myocardium and Evaluation of the Neonate

https://clinicaltrials.gov/study/NCT06186973

FAME-n

RECRUITING

FAME-n aims to improve perinatal care by introducing new approaches to fetal and neonatal heart assessment. Better identification of high-risk deliveries requiring intervention will reduce perinatal asphyxia-related illness and death. Neonatal hemodynamics may be improved by early detection of instability of the heart and circulation. Innovative use of technology enables characterization of normal and abnormal cardiovascular transition in a significantly larger number of fetuses and newborn infants than what was previously possible. The methods used may have broad generalizability and applicability in perinatal, neonatal and pediatric medicine. In September 2023, the project was expanded with an obstetric arm called Epidural analgesia: Fetal Oxygenation and Maternal Oxygenation (Epi-FOMO). In Epi-FOMO, the relationship between maternal breathing and arterial blood gases during labour, and umbilical cord blood gases and neonatal outcomes (as specified in FAME-n) will be investigated.

NO

Newborn Asphyxia|Hemodynamic Instability|Myocardium; Ischemic|Fetal Distress|Labor Pain

OTHER: Monitoring with Neobeat heart rate meter|OTHER: Maternal arterial blood gases|OTHER: Amniotic fluid lactate

Neonatal ECG, Blindly categorized neonatal ECG, From birth until 10 minutes of age|Cardiac enzymes, Umbilical cord blood cardiac enzymes: Creatine kinase (CK)-MB and troponin T, At the designated time for cord clamping as per clinical indication|Cardiac output, Cardiac output, From birth at least until 10 minutes of age|STAN, Blindly categorized STAN ECG raw data, 10 minutes prior to delivery

Autonomic function, Umbilical cord blood metanephrines, At the designated time for cord clamping as per clinical indication

Maternal arterial blood gases, Oxygen partial pressure (pO2) and carbondioxide partial pressure (pCO2), Four times during 1st stage of labor, during pushing and after delivery, maximum duration 24 hours of total labor time|Amniotic fluid lactate, Analyzed in 2mL amniotic fluid, Four times during 1st stage of labor, and during pushing, maximum duration 24 hours of total labor time

Oslo University Hospital

South-Eastern Norway Regional Health Authority

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

28911