Datasets:

pankajrajdeo

/

LungClinicalTrials

like 0

NCT05902273

The Value of Peripheral Arterial Resistive Index in Evaluation of Tissue Perfusion in Patients With Septic Shock

https://clinicaltrials.gov/study/NCT05902273

COMPLETED

In patients with septic shock, routine arterial blood pressure and central venous pressure are monitored in ICU. Conventional methods such as blood pressure and central venous pressure in septic patients cannot provide sufficient information in the follow-up due to the body s compensation mechanisms. The systemic vascular resistance index, which can be measured invasively or non-invasively with advanced hemodynamic monitoring methods, is a parameter that plays an important role in the management of septic patients. Resistive index (Pourcelot Index) is an ultrasonic measurement method used to evaluate tissue perfusion and microcirculation. Since peripheral tissue perfusion is impaired in septic patients, the investigators think resistive index may be useful for management of sepsis. There are studies in the literature on the use of resistive index in the follow-up of patients. The study will be about whether there is a correlation between the systemic vascular resistance index measured by cardiac output measurement, which is one of the advanced monitoring methods routinely used in the group requiring mechanical ventilation support in patients with septic shock, and the peripheral arterial resistive index, which is routinely used to evaluate tissue perfusion and microcirculation.

NO

Shock, Septic

DIAGNOSTIC_TEST: hemodynamic monitoring|DIAGNOSTIC_TEST: resistive index|DIAGNOSTIC_TEST: Pleth variability index

correlation of snuffbox radial artery resistive index and systemic vascular resistance index, correlation of snuffbox radial artery resistive index and systemic vascular resistance index, 1 hour. As soon as patient meets all of the inclusion criteria

correlation of snuffbox radial artery resistive index and pleth variability index, correlation of snuffbox radial artery resistive index and pleth variability index, 1 hour. As soon as patient meets all of the inclusion criteria|correlation of snuffbox radial artery resistive index and delta stroke volume index, correlation of difference in snuffbox radial artery resistive index and delta stroke volume index, 1 hour. As soon as patient meets all of the inclusion criteria|correlation of snuffbox radial artery resistive index and diastolic shock index, correlation of snuffbox radial artery resistive index and diastolic shock index, 1 hour. As soon as patient meets all of the inclusion criteria|correlation of snuffbox radial artery resistive index and central vena cava oxygen saturation and partial carbon dioxide pressure gap, correlation of snuffbox radial artery resistive index and central vena cava oxygen saturation and partial carbon dioxide pressure gap, 1 hour. As soon as patient meets all of the inclusion criteria|correlation of snuffbox radial artery resistive index and cardiac power index, correlation of snuffbox radial artery resistive index and cardiac power index, 1 hour. As soon as patient meets all of the inclusion criteria

Bezmialem Vakif University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Bezmialem V U

2022-04-01

2023-03-31

2023-03-31

2023-06-13

2023-06-13

Bezmialem Vakıf University, Fatih, İstanbul, 34093, Turkey

{ "hemodynamic monitoring": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "resistive index": [ { "intervention_type": "DIAGNOSTIC_TEST" } ], "Pleth variability index": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT04914273

Use of Exhaled Particles to Assess Lung Pharmacokinetics

https://clinicaltrials.gov/study/NCT04914273

EXPLORE

COMPLETED

This research project in humans aims at increasing the general understanding of lung pharmakokinetic by sampling exhaled particles. The central hypothesis of this study is that pharmacokinetics of Salbutamol (model drug) can be monitored in exhaled particles.

NO

Healthy|Lung Pharmacokinetic

DRUG: Inhalation Spray|DRUG: Tablet

Salbutamol concentration assessed in exhaled particles over 5 hours after inhaled versus oral administration, Before, 0 min, 20 min, 40 min, 60 min, 120 min, 180 min, 240 min, 270 min, 300 min after drug administration

Salbutamol concentration assessed in blood plasma over 5 hours after inhaled versus oral administration, Before, 0 min, 15 min, 35 min, 55 min, 75 min, 135 min, 195 min, 255 min, 285 min, 315 min after drug administration|Salbutamol concentration assessed in nasal filter samples (nasosorption) over 5 hours after inhaled versus oral administration, Before, 0 min, 15 min, 35 min, 55 min, 75 min, 135 min, 195 min, 255 min, 285 min, 315 min after drug administration|Safety and tolerability of the sampling method by assessing adverse events, Day 1 to Day 18

Fraunhofer-Institute of Toxicology and Experimental Medicine

AstraZeneca

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

21-15 EXPLORE

2021-06-14

2021-08-03

2021-08-03

2021-06-04

2021-08-19

Fraunhofer Institute for Toxicology and Experimental Medicine, Hannover, Lower Saxony, 30625, Germany

{ "Inhalation Spray": [ { "intervention_type": "DRUG" } ], "Tablet": [ { "intervention_type": "DRUG" } ] }

NCT03567473

Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study

https://clinicaltrials.gov/study/NCT03567473

BIPED

RECRUITING

We hypothesize that infants with bronchiolitis treated with inhaled epinephrine in the Emergency Department (ED) and a 2-day course of oral dexamethasone will have fewer hospitalizations over 7 days compared to infants treated with placebo. To examine this hypothesis, we will conduct a phase III, multicentre, randomized, double-blind trial. Infants presenting to one of twelve study EDs will be enrolled to one of two study groups: (1) inhaled epinephrine and oral dexamethasone or (2) inhaled placebo and oral placebo. Our primary outcome will be admission for bronchiolitis by day 7 following the enrolment. As a planned secondary analysis, a between-group comparison of the primary outcome will be performed in those patients presenting with a first episode of bronchiolitis.

NO

Bronchiolitis

DRUG: Oral dexamethasone|DRUG: Nebulized Epinephrine|DRUG: Oral placebo|DRUG: Nebulized normal saline|DRUG: MDI Epinephrine|DRUG: MDI placebo

Admission to hospital for bronchiolitis within 7 days post enrollment, 1) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater., 7 days post enrollment

Admission to hospital for bronchiolitis at the time of the enrollment ED visit, 1) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater., Enrollment visit|All cause admission to Hospital within 21 days following enrollment ED visit, 1) patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater., up to 21 days post enrollment|All cause Health care provider visits (including ED visits) by day 21 following enrollment ED, Visits to ED, other clinic, primary care provider, or any visit to see a nurse or physician following enrollment, up to 21 days post enrollment|Health Care related costs within the 21 days following enrollment ED visits., Health care related costs, up to 21 days post enrollment

Safety outcome 1: Gastrointestinal bleeding, involving melena or frank blood per rectum (and not attributable to other causes, as determined by the treating physician), up to 21 days post enrollment|Safety outcome 2: Serious Bacterial Infection, meningitis, osteomyelitis or septicaemia, up to 21 days post enrollment|Safety outcome 3: Severe Varicella, All of the following including: arthritis, osteomyelitis, symptomatic hepatitis, pancreatitis, cerebritis, pneumonitis, glomerulonephritis, disseminated intravascular coagulation, thrombo-cytopenia, prolonged vesicular rash (<3 weeks), fasciitis, septicaemia, ocular complications, orchitis, myocarditis, intensive care admission and death, up to 21 days post enrollment|Safety outcome 4: Death, Death, up to 21 days post enrollment|Exploratory Outcome 1: Admission to hospital for bronchiolitis within 21 days following enrollment ED visit, 1) Patient admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater., up to 21 days post enrollment|Exploratory Outcome 2: Admission to ICU within 21 days following enrollment ED visit for bronchiolitis and requiring intubation or continuous positive airway pressure (CPAP), Physician admitting patient to ICU for bronchiolitis and requiring oxygen or ventilatory support, up to 21 days post enrollment|Exploratory Outcome 3: All cause admission to hospital with 7 days following enrollment ED visit, 1) Patient admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater., up to 7 days post enrollment ED visit|Exploratory Outcome 4: All cause ED visits within 21 days following enrollment ED visit, Visits to the ED after initial enrollment ED visit, up to 21 days post enrollment ED|Exploratory Outcome 5: Length of stay for the enrollment ED visit (in hours), defined as discharge time minus oral study medication time, for participants discharged at the enrollment ED, Enrollment ED visit|Exploratory Outcome 6: Length of hospital admission for those patients admitted at their enrollment visit, time of hospital discharge minus the time of oral study medication, Admissions at enrollment ED visit|Exploratory Outcome 7: Resolution of symptoms as documented on a standardized questionnaire during the telephone or email at day 7 and 21 days., cough, noisy breathing, respiratory distress, sleep and ability to feed, up to 21 days post enrollment|Exploratory Outcome 8: Out of pocket expenses, transportation, days of missed work, missed leisure activities, up to 21 days post enrollment|Exploratory Outcome 9: Age dependent variation in the efficacy of epinephrine and dexamethasone, to determine if treatment efficacy varies by age, up to 21 days post enrollment|Exploratory Outcome 10: Health care utilization (including ambulatory visits, ED visits, hospitalization) for respiratory illness, future health care utilization, Up to 18 years of age|Exploratory Outcome 11: Development of respiratory illnesses, asthma, wheezing and other respiratory illnesses, Up to 18 years of age

Children s Hospital of Eastern Ontario

Canadian Institutes of Health Research (CIHR)|Children s Hospital Research Institute of Manitoba|Research Manitoba|Women and Children s Health Research Institute, University of Alberta|Alberta Children s Hospital Research Institute|The Hospital for Sick Children|Department of Pediatrics, Western University|St. Justine s Hospital

ALL

CHILD

PHASE3

OTHER

INTERVENTIONAL

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

CTO 1423

2018-12-13

2024-12-31

2025-06-30

2018-06-25

2023-10-10

Women and Children s Hospital, Adelaide, 5006, Australia|Monash Medical Centre, Melbourne, 3168, Australia|Perth Children s Hospital, Perth, 6008, Australia|Children s Hospital of Alberta, Calgary, Alberta, T3B 6A9, Canada|Stollery Children s Hospital, Edmonton, Alberta, T6G 2C8, Canada|Childrens Hospital at London Health Sciences, London, Ontario, N6A 5W9, Canada|CHEO, Ottawa, Ontario, K1H 8L1, Canada|CHU Sainte-Justines Hospital, Montréal, Quebec, HT3 1C5, Canada|Children s Hospital of Winnipeg, Sherbrook, Winnipeg, R3A 1S1, Canada|Starship Children s Hospital, Auckland, 1142, New Zealand|Kidz First Hospital, Auckland, 2025, New Zealand|Waikato Hospital, Hamilton, 3240, New Zealand

{ "Dexamethasone": [ { "intervention_type": "DRUG", "description": "Oral dexamethasone", "name": "Dexamethasone", "synonyms": [ "Millicorten", "1-Dehydro-16\u03b1-methyl-9\u03b1-fluorohydrocortisone", "Dextenza", "Decaject-L.A.", "Cortidex", "Dexpak", "Dexam\u00e9thasone", "Dexasone", "Decameth", "Dexametasona", "Methylfluorprednisolone", "Decadron", "Martapan", "Decaspray", "16\u03b1-Methyl-9\u03b1-fluoro-1-dehydrocortisol", "Dexamethasone", "Decaject", "Ozurdex", "16alpha-Methyl-9alpha-fluoro-1-dehydrocortisol", "Decaject L.A.", "TobraDex", "Maxidex", "Hexadrol", "Dexair", "Dexamethasonum", "Dexacidin", "Oradexon", "Hexadecadrol", "Glensoludex", "Neofordex", "Maxitrol", "1-Dehydro-16alpha-methyl-9alpha-fluorohydrocortisone", "9\u03b1-Fluoro-16\u03b1-methylprednisolone", "9alpha-Fluoro-16alpha-methylprednisolone", "Maxidex", "Dexamethasone eye drops", "Eythalm", "Dexafree", "Dropodex", "Maxidex", "Dexamethasone eye drops", "Eythalm", "Dexafree", "Dropodex" ], "medline_plus_id": "a682869", "generic_names": [ "Dexamethasone" ], "nhs_url": "https://www.nhs.uk/medicines/dexamethasone-tablets-and-liquid", "mesh_id": "D018931", "drugbank_id": "DB01234", "wikipedia_url": "https://en.wikipedia.org/wiki/Dexamethasone" } ], "Epinephrine": [ { "intervention_type": "DRUG", "description": "Nebulized Epinephrine", "name": "Epinephrine", "synonyms": [ "(R)-(\u2212)-adrenaline", "Levoepinephrine", "Epinephrin", "Epinefrina", "Adrenaline", "Adrenaline Bitartrate", "Epinephrine", "Epinephrine Bitartrate", "(R)-(-)-Adnephrine", "Epifrin", "Epitrate", "Epinephrinum", "Medihaler-Epi", "(R)-(-)-Adrenaline", "Primatene Mist", "Adr\u00e9naline", "EpiPen", "Twinject", "Adrenaline Acid Tartrate", "Epinephrine Hydrochloride", "Adrenaline Hydrochloride", "4-(1-Hydroxy-2-(methylamino)ethyl)-1,2-benzenediol", "L-Adrenaline", "4-[(1R)-1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol", "(R)-(-)-Epinephrine", "Auvi-Q", "Acetate, Epinephrine", "Adrenaclick", "(\u2212)-(R)-epinephrine", "(\u2212)-3,4-dihydroxy-\u03b1-((methylamino)methyl)benzyl alcohol", "(R)-(-)-Epirenamine", "Epinefrin", "Lyophrin", "(\u2212)-adrenaline", "Epinephrine Acetate", "Epinephrine Hydrogen Tartrate" ], "medline_plus_id": "a619002", "generic_names": [ "Epinephrine" ], "mesh_id": "D014662", "drugbank_id": "DB00668" }, { "intervention_type": "DRUG", "description": "MDI Epinephrine", "name": "Epinephrine", "synonyms": [ "(R)-(\u2212)-adrenaline", "Levoepinephrine", "Epinephrin", "Epinefrina", "Adrenaline", "Adrenaline Bitartrate", "Epinephrine", "Epinephrine Bitartrate", "(R)-(-)-Adnephrine", "Epifrin", "Epitrate", "Epinephrinum", "Medihaler-Epi", "(R)-(-)-Adrenaline", "Primatene Mist", "Adr\u00e9naline", "EpiPen", "Twinject", "Adrenaline Acid Tartrate", "Epinephrine Hydrochloride", "Adrenaline Hydrochloride", "4-(1-Hydroxy-2-(methylamino)ethyl)-1,2-benzenediol", "L-Adrenaline", "4-[(1R)-1-Hydroxy-2-(methylamino)ethyl]-1,2-benzenediol", "(R)-(-)-Epinephrine", "Auvi-Q", "Acetate, Epinephrine", "Adrenaclick", "(\u2212)-(R)-epinephrine", "(\u2212)-3,4-dihydroxy-\u03b1-((methylamino)methyl)benzyl alcohol", "(R)-(-)-Epirenamine", "Epinefrin", "Lyophrin", "(\u2212)-adrenaline", "Epinephrine Acetate", "Epinephrine Hydrogen Tartrate" ], "medline_plus_id": "a619002", "generic_names": [ "Epinephrine" ], "mesh_id": "D014662", "drugbank_id": "DB00668" } ], "Oral placebo": [ { "intervention_type": "DRUG" } ], "Nebulized normal saline": [ { "intervention_type": "DRUG" } ], "MDI placebo": [ { "intervention_type": "DRUG" } ] }

NCT04428073

Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

https://clinicaltrials.gov/study/NCT04428073

UNKNOWN

GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled sequentially into low dose and high dose groups. Following the vaccination subjects who received at least one vaccination will be followed for safety through week 26.

NO

COVID

BIOLOGICAL: Covax-19™

To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities., Frequency and severity of adverse events, laboratory abnormalities, local and systemic reactogenicity, signs and symptoms after vaccinations., 26 weeks

To evaluate the immunogenicity of a therapeutic Covid-19 vaccine in participants by measuring CD8+ T cells immune response, Magnitude of IFN-γ producing CD8+ T cells to SARS-CoV-2 nucleocapsid peptides pools after vaccinations., 6 weeks|Virologic response after vaccination, Detection of SARS-CoV-2 by RT-PCR in respiratory tract specimens at week 0, 1, 2, 3, and 4., 4 weeks|Clinical outcome and progression after vaccinations, Number of participants with moderate, severe or critical Covid-19 at week 6., 6 weeks

GeneCure Biotechnologies

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

GC004

2020-07

2021-07

2021-12

2020-06-11

2020-06-11

{ "Covax-19\u2122": [ { "intervention_type": "BIOLOGICAL", "description": "Covax-19\u2122", "name": "Covax-19\u2122", "synonyms": [ "", "Covax-19\u2122" ], "drugbank_id": "DB15846", "generic_names": [ "Covax-19\u2122" ] } ] }

NCT05375773

Povidone Iodine Nasal Irrigation and Gargling to Reduce Viral Load in Asymptomatic Patients With COVID-19

https://clinicaltrials.gov/study/NCT05375773

SMART-CORE

UNKNOWN

The emergence of a novel coronavirus(SARS-CoV-2) in late 2019 has resulted in a global epidemic of the infectious condition COVID-19. Since March 2022, the Omicron mutant has caused widespread transmission in Shanghai, China, and is characterized by the majority of asymptomatic patients. Although showing no obvious symptoms, the asymptomatic patients have high transmissibility because of high viral loads in their oropharynx and nasopharynx. Therefore，this study puts forwards the hypothesis that local flushing treatment in the sino-nasal and mouth cavity can reduce the viral load to reduce their transmissibility. Nasal Irrigation and gargling is a safe and commonly used mechanism to treat a variety of sinonasal diseases including sinusitis, rhinitis, and upper respiratory tract infections. Povidone-iodine(PVP-I) is a water-soluble complex of povidone, a carrier molecule, and iodine, which has powerful microbicidal activity. Also, recent evidence of in-vitro virucidal action of povidone-iodine in Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS CoV-2) has been supported. Therefore, the study is designed to assess the virucidal effect of nasal irrigation and gargling with PVP-I against SARS-CoV-2 located in the throat. The hypothesis was that the treatment would be effective in improving the negative conversion rate of SARS-CoV-2 nucleic acid on day 10.

NO

2019 Novel Coronavirus Infection

OTHER: PVP-I Nasal Irrigation and gargling

negative conversion rate, On the 10th day after entering the Fang Chang Hospital, the negative conversion rate of novel coronavirus nucleic acid detected by nasopharyngeal sampling. the turning negative is defined as the person whose nucleic acid detection is negative for two times after an interval of more than 24 hours according to the diagnosis and treatment for novel coronavirus pneumonia (Trial Nine Edition)., the 10th day after entering the Fang Chang Hospital

negative conversion rate, the negative conversion rate of novel coronavirus nucleic acid detected by nasopharyngeal sampling, the 5th 、7th and 14th day after entering the Fang Chang Hospital|the length of time for patient s when nucleic acid result turns to be negative, Number of days, 1-14 days or until the nucleic acid result is negative|Intraoral viral load, Intraoral viral load as deciphered by Reverse transcription polymerase chain reaction (RT-PCR) testing, 10th day of using Nasal Irrigation and gargling|Number of participants reporting side effects of nasal irrigation, Number of participants in intervention arm reporting side effects, 1-14 days or until the participant reports that they are well|Self-reported clinical discomfort, Number of participants reported, including headache, cough, runny nose, chest pain, fever, muscle soreness / fatigue, diarrhea / nausea / vomiting, loss of taste / smell and other symptoms, 1-14 days or until the participant reports that they are well

Ruijin Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

xmq21966

2022-04-16

2022-08-31

2022-10-31

2022-05-17

2022-05-24

Ruijin Hospital,Shanghai Jiaotong University school of medicine, Shanghai, Shanghai, China

{ "Povidone-iodine": [ { "intervention_type": "OTHER", "description": "PVP-I Nasal Irrigation and gargling", "name": "Povidone-iodine", "synonyms": [ "Iodopovidone", "Povidone, iodinated", "PVP-I", "Povidone-iodine", "Povidone iodine" ], "drugbank_id": "DB06812", "generic_names": [ "Povidone-iodine" ] } ] }

NCT01314573

The Impact of High Intensity Exercise Upon EPC Number and Function in Young Women

https://clinicaltrials.gov/study/NCT01314573

UNKNOWN

The purpose of the study is to examine the effects of different exercise intensity training programs upon blood vessel function and circulating blood cells involved in blood vessel repair in young women. The long term effects of exercise may be beneficial to cardiovascular health and it is important to understand the training methods that are the most beneficial. In particular we aim to determine if brief maximal exercise improves the function and stiffness of blood vessels and enhance blood vessel repair. Two methods of exercising are being compared, exercise bouts involving intermittent exercise and exercise completed all at once, but at a very high intensity.

NO

Exercise Anaphylaxis

BEHAVIORAL: Sprint interval exercise|BEHAVIORAL: Maximal continuous exercise

Maximal oxygen uptake, A measure of aerobic capacity determined during an incremental exercise test to volitional fatigue on an exercise ergometer., 4 weeks

Heart rate variability, 4 weeks|Endothelial progenitor cell function, measures of in vitro cell migratory ability, adhesion and classification of endothelial progenitor cells, 4 weeks|Flow mediated dialtion, Measure of vascular endothelial function determined non-invasively at the brachial artery, 4 weeks|Arterial stiffness, The stiffness of the carotid artery is measured using a combination of ultrasound imaging and non-invasive blood pressure measurements. Lower degrees of stiffness are more favourable., 4 weeks|Circulating angiogenic cell numbers, These cells are involved in vascular repair and proliferation and may be measured using flow cytometric methods. Specifically cells with CD34 and CD309 antigens are enumerated., 4 weeks|Endothelial progenitor cell function, Measure of in vitro migratory, adhesion and classification of endothelial progenitor cells., 4 weeks

University of Leeds

FEMALE

ADULT

OTHER

INTERVENTIONAL

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

BIOSCI-10-007

2011-03

2012-09

2012-11

2011-03-14

2011-03-14

University of Leeds, Leeds, West Yorkshire, LS2 9JT, United Kingdom

{ "Sprint interval exercise": [ { "intervention_type": "BEHAVIORAL" } ], "Maximal continuous exercise": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04103073

Respiratory and Submental Muscles Activity During Inspiration and Expiration in Obstructive Sleep Apnea Syndrome

https://clinicaltrials.gov/study/NCT04103073

COMPLETED

In this study respiratory and submental muscle activities during during inspiratory and expiratory breathing maneuver at specific workloads will be assessed according to inspiratory and expiratory muscle strength of each obstructive sleep apnea syndrome (OSAS) patient s.

NO

Obstructive Sleep Apnea

Pulmonary function test, Pulmonary function will be assessed with a portable spirometer thorough the standard procedures. Pulmonary function test results will be recorded during the inspiratory and expiratory maneuver., about thirty minutes|Respiratory muscle strength, Respiratory muscle strength will be measured with a respiratory pressure meter. Maximal inspiratory pressure and expiratory pressure were recorded., about thirty minutes|Surface electromyographic (sEMG) measurement of submental muscles and diaphragm, Surface electromyographic (sEMG) activity of the submental muscle group (including the anterior belly of the digastric, mylohyoid, geniohyoid, and platysmas) and diaphragm will be measured during inspiratory and expiratory maneuver., about thirty minutes

Hacettepe University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

osasemg

2019-09-16

2021-09-14

2021-12-14

2019-09-25

2022-01-20

Hacettepe University, Faculty of Pyhsical Therapy and Rehabilitation, Ankara, Turkey

{}

NCT06381973

Ventilation Distribution in COPD Patients During Breathing Exercises

https://clinicaltrials.gov/study/NCT06381973

RECRUITING

ELTGOL (Slow Expiration with the Opened Glottis in the Lateral posture) is an airway clearance technique performed in the lateral decubitus position. This technique focuses on optimizing ventilation of the infralateral lung (when the subject is lying in the lateral posture) to enhance local air-liquid interaction. Previous studies on ventilation differences between the infra- and supralateral lungs were conducted on healthy, young, male subjects, without the application of thoracic or abdominal pressure. This study aimed to assess ventilation distribution in right lateral recumbency in patients with chronic obstructive pulmonary disease (COPD), as well as healthy individuals, and investigate the impact of thoracic and abdominal manual pressures during ELTGOL on ventilation distribution.

NO

Chronic Obstructive Pulmonary Disease|Healthy

BEHAVIORAL: ELTGOL_Physio|BEHAVIORAL: ELTGOL_Auto|DEVICE: PEP|BEHAVIORAL: 1L-Tidal-Breathing|BEHAVIORAL: Spontaneous Breathing

Impedance variation using Electrical Impedance Tomography, Impedance change in the right and left lungs, 2 minutes during intervention

William Poncin, PT, PhD

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

ELTGOL

2024-04-15

2024-08-01

2024-08-01

2024-04-24

2024-04-25

Cliniques universitaires Saint-Luc, Brussels, Brussels Capital, 1200, Belgium

{ "ELTGOL_Physio": [ { "intervention_type": "BEHAVIORAL" } ], "ELTGOL_Auto": [ { "intervention_type": "BEHAVIORAL" } ], "PEP": [ { "intervention_type": "DEVICE" } ], "1L-Tidal-Breathing": [ { "intervention_type": "BEHAVIORAL" } ], "Spontaneous Breathing": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05526573

Diagnostic Yeld of Ultrathin Bronchoscopy in Peripheral Pulmonary Lesions

https://clinicaltrials.gov/study/NCT05526573

RECRUITING

The use of an ultrathin bronchoscope (UB) has recently been introduced in the diagnosis of peripheral lung lesions. The use of the UB can be supported by navigation systems such as fluoroscopy, ultrasound guidance, electromagnetic navigation, or other technologies, which have complementary potential. Further navigation techniques are still under study. The use of ultrathin instrumentation has already been shown to significantly reduce procedural times compared to traditional instrumentation. The purpose of the study is to prospectively evaluate the institutional experience of different third-level hospital centers with the use of a UB (MP190F; Olympus Medical Systems, Tokyo, Japan) for sampling peripheral lung lesions by means of transbronchial needle aspiration (TBNA) or transbronchial biopsy (TBB), performed after fluoroscopic navigation and simultaneous radial probe-endobronchial ultrasound (RP-EBUS) assessment. Design: multicentric, observational study.

NO

Lung Cancer|Lung; Node|Lung Diseases|Lung TB|Lung Adenocarcinoma|Lung Transplant Rejection

DEVICE: Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)

Evaluate the overall diagnostic accuracy, Sensitivity, specificity, positive predictive value, negative predictive value, Within 12 months from the procedure

Agreement between the definitive pathological result and the rapid on-site evaluation (R.O.S.E.), Comparison (% of concordant and % of discordant results) between R.O.S.E. (performed during the procedure by the pulmonologist or by the pathologist) and the final result obtained after the evaluation (by the pathologist) of the samples taken., Within 15 days from the procedure|Evaluation of patient satisfaction at the end of the procedure (Likert scale in relation to the memory of the procedure and the willingness to repeat it in the future.), Patients will undergo two satisfaction questionnaires, set according to Likert scale, at the end of the endoscopic procedure., Same day of the procedure|Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and diagnostic accuracy, Within 12 months from the procedure|Correlation between the type of anesthesia, the characteristics of the lesion, the procedural dynamics and patient satisfaction, Correlations will be made between the anesthetic, radiological and procedural parameters with respect to the answers obtained in the satisfaction questionnaires., Same day of the procedure

Azienda Sanitaria-Universitaria Integrata di Udine

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

4393

2022-07-14

2025-07-31

2025-12-31

2022-09-02

2024-02-02

Pneumologia, Azienda Ospedaliero-Universitaria Ospedali Riuniti, Ancona, Italy|Pneumologia, Arcispedale S. Maria Nuova, Reggio Emilia, Italy|Pneumologia, ASUFC, Az. Osp. Santa Maria della Misericordia, Udine, Italy

{ "Ultrathin bronchoscopy (MP190F; Olympus Medical Systems, Tokyo, Japan)": [ { "intervention_type": "DEVICE" } ] }

NCT04643873

Effects of Physical Activity in Patients With Diabetes

https://clinicaltrials.gov/study/NCT04643873

UNKNOWN

The primary aim of our study is to evaluate the effects of physical activity counseling and pilates exercises on metabolic control variables in patients with prediabetes and type 2 diabetes; Its secondary aim is to examine the effects of both practices on physical activity level, exercise capacity and quality of life, and to compare the relationship between those under medical supervision by family doctor.

NO

Diabetes Mellitus|PreDiabetes

OTHER: physical activity counseiling +pilates exercise group|BEHAVIORAL: physical activity counseiling group

fasting blood glucose, A fasting blood sugar level less than 100 mg/dL (5.6 mmol/L) is normal. A fasting blood sugar level from 100 to 125 mg/dL (5.6 to 6.9 mmol/L) is considered prediabetes. If it s 126 mg/dL (7 mmol/L) or higher on two separate tests, you have diabetes percentage of body fat, amount of visceral fat, body mass index: amount of muscle mass in the trunk and extremities, through study completion, an average of 1 day|HbA1c, A hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to hemoglobin. Normal: HbA1c below 5.7% Prediabetes: HbA1c between 5.7% and 6.4% Diabetes: HbA1c of 6.5% or higher, through study completion, an average of 1 day|HDL, HDL (high-density lipoprotein cholesterol) cholesterol: High density lipoprotein cholesterol.60 mg/dL (1.6 mmol/L) or above is desirable, through study completion, an average of 1 day|LDL, LDL (low-density lipoprotein cholesterol) Adult - < 130 mg/dL is normal value for LDL. Low-density lipoprotein is a type of lipoprotein that consists of cholesterol (LDL cholesterol, LDL-C) and similar substances with a small amount of protein, through study completion, an average of 1 day|total cholesterol, Total cholesterol a measure of the total amount of cholesterol in your blood. It includes both low-density lipoprotein (LDL) cholesterol and high-density lipoprotein (HDL) cholesterol. Less than 200 mg/dL is normal, through study completion, an average of 1 day|triglyceride values, Triglycerides are a type of fat (lipid) found in blood. Normal is less than 150 milligrams per deciliter (mg/dL), or less than 1.7 millimoles per liter (mmol/L), through study completion, an average of 1 day|BMI (body mass index), Weight and height will be combined to report BMI in kg/m^2. Underweight = <18.5 Normal weight = 18.5-24.9 Overweight = 25-29.9. Obesity = BMI of 30 or greater, through study completion, an average of 1 day|percentage of body fat, Body fat percentage will be calculated with the Jawon X-Contact 350 device, through study completion, an average of 1 day|amount of visceral fat, Amount of visceral fat will be calculated with the Jawon X-Contact 350 device. Visceral fat is wrapped around major organs like the liver, pancreas and your kidney. Visceral fat ensures that there is some distance between each organ. Too much visceral fat creates can lead to inflammation and high blood pressure, which increases the risk of serious health problems. This is also know as central obesity. Based on all the available information Jawon X Contact 350 device gives you a range between 1 and 59. A rating between 1 and 12 indicates that you have a healthy level of visceral fat. A rating between 13 and 59 indicates that you have an excessive level of visceral fat., through study completion, an average of 1 day|Muscle mass amounts in the trunk and extremities, Muscle mass amounts in the trunk and extremities will be calculated with the Jawon X-Contact 350.Muscle mass includes the skeletal muscles, smooth muscles such as cardiac and digestive muscles and the water contained in these muscles, through study completion, an average of 1 day

Long version of IPAQ (International Physical Activity Questionnaire), Long version of IPAQ will be used to measure physical activity level . There are three levels of physical activity proposed to classify populations - low , moderate , and high Vigorous Intensity = 8.0 METs Moderate Intensity = 4.0 METs, through study completion, an average of 1 day|SF36 (Short Form 36), SF36 will be used to measure quality of life Scoring between 0-100 High score means higher quality of life, through study completion, an average of 1 day|6 minutes walk test, 6 minutes walk test will be used to measure exercise capacity The six minute walk distance in healthy adults has been reported to range from 400m to 700m Age and sex-specific reference standards are available and may be helpful for interpreting 6MWT scores for both healthy adults and those with chronic diseases 47 . However, it is difficult to use normative values because of the differing methods used in studies. An improvement of 54m has been shown to be a clinically important difference24 in a study of people with chronic lung disease which is similar to the recommended criteria of meaningful clinical change of 50m based on analyses from a sample of 692 community living older adults and individuals who have survived a stroke 25, through study completion, an average of 1 day

Istanbul University - Cerrahpasa (IUC)

FEMALE

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

13022260-300-95767

2020-01-06

2021-09-06

2021-10-06

2020-11-25

2020-11-25

Merve Suay, Hatay, 31350, Turkey

{ "physical activity counseiling +pilates exercise group": [ { "intervention_type": "OTHER" } ], "physical activity counseiling group": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT04192773

An fMRI Investigation of the Effects of IV Lidocaine on Tinnitus

https://clinicaltrials.gov/study/NCT04192773

RECRUITING

This is an exploratory pilot open-label study to identify the signal changes on fMRI of patients with tinnitus and with temporary suppression of the tinnitus with IV lidocaine. Patients will include those with hearing loss (both unilateral and bilateral) and tinnitus, subjects with normal hearing and tinnitus, and control subjects with normal hearing and no tinnitus. Eligible subjects will have functional and subjective data collected at baseline, receive an IV lidocaine infusion, and have functional and subjective data collected post-infusion for comparison and identification of involved neural networks.

NO

Tinnitus

DRUG: IV Lidocaine

Compare fMRI scans pre- and post-lidocaine administration to identify neural networks associated with chronic tinnitus., The investigators will scan the patient in fMRI prior to IV lidocaine administration. After the infusion, patient will get another fMRI scan to assess any neural changes in the primary auditory cortex and associated salience, limbic and cognitive regions., 60 MINUTES

Change in subjective assessment of tinnitus via Tinnitus Handicap Inventory (THI) questionnaire from baseline to post-infusion., Patients will be given the questionnaire at baseline to evaluate their tinnitus. The purpose of this questionnaire is to identify difficulties that patients may be experiencing because of their tinnitus. The patients can choose to answer yes , sometimes , and no to these questions. The higher scores mean worse outcome. The same questionnaire will be given after the infusion to compare questionnaire responses., 30 MINUTES|Change in subjective assessment of tinnitus via Tinnitus Functional Index (TFI) questionnaire from baseline to post-infusion., Patients will be given the questionnaire at baseline to evaluate their tinnitus. Multiple questions probing how the patient s tinnitus has affected different social aspects of their lives are evaluated on the scale of 0 to 10. The higher scores indicate a worse outcome. The same questionnaire will be given after the infusion to compare questionnaire responses., 30 MINUTES|Change in subjective assessment of tinnitus via Visual Analog Scale (VAS) questionnaire from baseline to post-infusion., Patients will be given the questionnaire at baseline to evaluate their tinnitus. The scale evaluates tinnitus loudness, annoyance felt by the patient due to the tinnitus, distress experienced by the patient, and his/her ability to cope with tinnitus. The scale is 10cm long, labeled with min on the left side and max on the right side. Higher scores on the first three categories mean worse outcomes and lower score on the ability to cope means worse outcome. The same questionnaire will be given after the infusion to compare questionnaire responses., 30 MINUTES|Compare blood oxygen level (O2) dependent signal derived from pre- and post-infusion fMRI., The investigators will compare measured blood O2 level dependent activity on fMRI images pre- and post-infusion., 30 MINUTES

Massachusetts Eye and Ear Infirmary

ALL

ADULT, OLDER_ADULT

EARLY_PHASE1

OTHER

INTERVENTIONAL

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

2019P0002539

2021-04-28

2024-11

2024-12

2019-12-10

2023-10-19

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, 02114, United States

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

NCT02012673

A Safety and Feasibility Study of Re-treating Patients With Severe Emphysema With the RePneu LVRC System.

https://clinicaltrials.gov/study/NCT02012673

RECOIL

COMPLETED

Rationale: The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline. Objective: To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.

NO

COPD|Emphysema

DEVICE: Bronchoscopic lung volume reduction

Number and type of adverse effects as a measure of safety between baseline and 6 months follow up, The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects., Baseline - 6 month follow up

Change from Baseline in Lung function at 2 months, -Changes in FEV1 and FVC, 2 months following treatment, Baseline vs 2 month follow up|Change from Baseline in Quality of life at 2 months, * Change in the SGRQ score, 2 months following treatment * Change in the CCQ score, 2 months following treatment, Baseline vs 2 month follow up|Change from Baseline in functional measures at 2 months, * Change in the mMRC score, 2 months following treatment * Change in the 6MWD, 2 months following treatment, Baseline vs 2 month follow up|Change from Baseline in Lung function at 6 months, * Change in RV, 6 months following treatment * Change in RV/TLC ratio, 6 months following treatment * Changes in FEV1 and FVC, 6 months following treatment, Baseline vs 6 month follow up|Change from Baseline in quality of life at 6 months, * Change in the SGRQ score, 6 months following treatment * Change in the CCQ score, 6 months following treatment, Baseline vs 6 month follow up|Change from Baseline in functional measures at 6 months, * Change in the mMRC score, 6 months following treatment * Change in the 6MWD, 6 months following treatment, Baseline vs 6 month follow up

University Medical Center Groningen

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

RECOIL-study

2014-01

2016-09

2016-09

2013-12-16

2017-06-27

University Medical Center Groningen, Groningen, Netherlands

{ "Bronchoscopic lung volume reduction": [ { "intervention_type": "DEVICE" } ] }

NCT01480973

Stereotactic Body Radiotherapy (RT) for Non-Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT01480973

COMPLETED

NSCLC is the leading cause of cancer mortality in North America, accounting for nearly 30% of all cancer deaths. The standard treatment for patients with early-stage non-small-cell lung cancer (NSCLC) is surgical resection of the involved lobe/lung. However, many patients are unable to undergo such a major surgery due to medical illness, and an emerging standard-of-care for these patients stereotactic-body radiation therapy (SBRT). SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few fractions (hypofractionation) to accurately describe, size-restricted malignant targets in which motion has been accounted for during the delivery process. SBRT administration achieves avoidance of normal tissue exposure to radiation during the planning process, by providing for sharp fall-off dose gradients outside the target.

NO

Non Small Cell Lung Cancer

RADIATION: Stereotactic Body Radiation Therapy

Optimal MRI parameters and sequences to characterize lung changes observed after SBRT for early-stage NSCLC., MRI pulse sequence settings, 2 years|MRI characteristics of benign (fibrosis), malignant (recurrence), and indeterminate lung changes observed after SBRT for early-stage NSCLC., MRI tissue contrast, 2 years

Reliability and reproducibility of thoracic MRI to distinguish between benign (fibrosis), malignant (recurrence), and indeterminate lung changes following SBRT for early-stage NSCLC., Sensitivity, specificity, positive and negative predictive value, 2 years

University Health Network, Toronto

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

UHN REB 11-0079-CE

2011-06

2017-07

2020-05-29

2011-11-29

2021-10-05

Princess Margaret Hospital, University Health Network, Toronto, Ontario, M5G 2M9, Canada

{ "Stereotactic Body Radiation Therapy": [ { "intervention_type": "RADIATION" } ] }

NCT05752773

Prediction of Myocardial Injury After Laparoscopic Pheochromocytoma/ParaGangLioma Resection

https://clinicaltrials.gov/study/NCT05752773

MI-PPGL

RECRUITING

This observational study was conducted in patients undergoing elective laparoscopic pheochromocytoma/paraganglioma(PPGL) resection. It mainly answers the following two main questions: 1. What are the risk factors for myocardial injury after laparoscopic PPGL resection？ 2. How to establish the myocardial injury prediction model of laparoscopic PPGL resection? Participants were not required to perform additional research work other than the usual postoperative follow-up within 30 days after surgery. No control group was set in this study, and no additional clinical intervention was performed.

NO

PGL

Myocardial injury after laparoscopic PPGL resection, Myocardial injury was defined as an elevated troponin I level exceeding the 99th percentile upper reference limit due to cardiac ischemic causes., 30days after surgery

Acute myocardial infarction, An increase in troponin exceeding 99% of the reference limit is associated with at least one of the following: 1. Symptoms of myocardial ischemia; 2. New ECG ischemic changes (ST elevation or depression or abnormal Q wave; 3. Imaging findings of abnormal new ventricular wall movement or loss of viable myocardia consistent with ischemic etiology; 4. Coronary thrombosis was confirmed by coronary intervention (angiography) or autopsy., 30days after surgery|Nonfatal cardiac arrest, An event in which cardiac activity abruptly stops, usually through CPR and/or defibrillation or cardioversion, or cardiac pacing reversal, resulting in a loss of normal signs of breathing and spontaneous circulation., 30days after surgery|Congestive heart failure, Patients with new postoperative symptoms and signs: fatigue, dyspnea, upright breathing, paroxysmal dyspnea at night, increased jugular vein pressure, wet rales found on physical examination, heart enlargement, pulmonary vascular congestion., 30days after surgery|New atrial fibrillation, new atrial fibrillation heart rate confirmed by electrocardiogram or color Doppler ultrasound after surgery., 30days after surgery|Stroke, CT or MRI showing cerebral infarction or cerebral hemorrhage or new neurological symptoms (hemiplegia, decreased muscle strength, or dysphonia) lasting more than 24 hours, 30days after surgery

Peking Union Medical College Hospital

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2022-PUMCH-B-0071

2023-02-06

2025-05-31

2025-05-31

2023-03-03

2023-03-08

Peking Union Medical College Hospital,Chinese Academy of Medical Science and Peking Union Medical College, Beijing, Beijing, 100730, China

{}

NCT03176173

Radical-Dose Image Guided Radiation Therapy in Treating Patients With Metastatic Non-small Cell Lung Cancer Undergoing Immunotherapy

https://clinicaltrials.gov/study/NCT03176173

ACTIVE_NOT_RECRUITING

This phase II trial studies how well radical-dose image guided radiation therapy works in treating patients with non-small cell lung cancer that has spread to other places in the body who are undergoing immunotherapy. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radical-dose image guided radiation therapy to patients with non-small cell lung cancer may help to improve response to immunotherapy anti-cancer treatment.

NO

Stage IV Non-Small Cell Lung Cancer

RADIATION: Image-guided Radiation Therapy|DRUG: Immunotherapy (physician s choice for standard of care immunotherapy)

Progression-free survival, Defined as proportion of patients without Response Evaluation Criteria in Solid Tumors version 1.1 disease progression or death 24 weeks from date of study entry., At 24 weeks after study entry

Change in circulating tumor deoxyribonucleic acid levels as measured using CAncer Personalized Profiling by deep Sequencing, Will correlate with radiographic response. Plasma biomarkers (e.g. cell free deoxyribonucleic acid level) will be summarized using medians and interquartile ranges; changes in biomarkers will be assessed using the Wilcoxon signed rank test. Correlation of biomarkers with radiographic response will be evaluated using a Wilcoxon rank sum test on patients with and without the event of interest. If feasible, these analyses will be supplemented by more formal analyses with the Cox model., Baseline up to 1 year after study entry|Change in immune marker levels as measured from peripheral blood using flow cytometry performed by the Human Immune Monitoring Core at Stanford University, Will correlate with radiographic response., Baseline up to 1 year after study entry|Incidence of acute (0-6 months) and late (> 6 months) grade 3-5 toxicity, Measured with Common Terminology Criteria for Adverse Events version 4., Up to 4 years after study entry|Overall survival, The electronic medical record will be monitored for patient deaths., Time from study entry to death, assessed up to 4 years after study entry

Patterns of response and progression, Patterns of response and progression, including abscopal responses will be measured., Up to 4 years|Progression free survival, Evaluated with immune-related Response Criteria., Up to 4 years|Time to discontinuation of study immunotherapy agent, Time to discontinuation of study immunotherapy agent will be measured., Up to 4 years

Stanford University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

IRB-40088|NCI-2017-00952|LUN0088

2017-06-28

2021-11-24

2026-05-01

2017-06-05

2024-06-21

Stanford University, School of Medicine, Palo Alto, California, 94304, United States

{ "Image-guided Radiation Therapy": [ { "intervention_type": "RADIATION" } ], "Immunotherapy (physician s choice for standard of care immunotherapy)": [ { "intervention_type": "DRUG" } ] }

NCT04238273

High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure for Respiratory Support of Preterm Neonates

https://clinicaltrials.gov/study/NCT04238273

COMPLETED

This work is designed to: 1. Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates. 2. Investigate hemodynamic changes associated with HHHFNC in comparison to nCPAP in preterm neonates during periods of non-invasive respiratory support and after being off support.

NO

Respiratory Distress Syndrome, Newborn

DIAGNOSTIC_TEST: Functional Echocardiography

Echocardiography study for preterm neonates among the two study groups while on and off non invasive ventilation., Done using Bedside functional echocardiography to record Superior vena caval flow (ml/kg/min), right ventricular output flow (ml/kg/min) and left ventricular output flow (ml/kg/min) for each preterm neonate in one of the two study groups (using either HHHFNC and nCPAP) on and off respiratory support., 2 years

Evaluate the efficacy of HHHFNC in comparison with nCPAP in preterm neonates., The percentage of success and failure among the HHHFNC and nCPAP groups , success defined as the preterm neonate that will not require invasive ventilation, while failure as the preterm neonate that will require invasive ventilation., 2 years|Anterior cerebral artery Doppler (measuring resistive index) and preprandial Superior mesenteric artery Doppler (measuring resistive index)., Anterior cerebral artery resistive index and preprandial Superior mesenteric artery resistive index measured for 70 preterm neonate on and off non invasive ventilation. 35 preterm placed on HHHFNC in comparison to 35 preterm placed on nCPAP., 2 years|Preprandial Superior mesenteric artery Doppler measuring superior mesenteric artery blood flow(mL/sec), Preprandial Superior mesenteric artery blood flow(mL/sec) measured for 70 preterm neonate on and off non invasive ventilation. 35 preterm placed on HHHFNC in comparison to 35 preterm placed on nCPAP., 2 years

Ain Shams University

ALL

CHILD

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

FMASU MD 386/2017

2018-01-31

2019-11-30

2020-01-01

2020-01-23

2020-01-23

38 abbasia, next to nour mosque, Ain Shams University Hospital, Pediatrics department, Cairo, 11517, Egypt

{ "Functional Echocardiography": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT01161173

An Observational Study of Tarceva (Erlotinib) in Routine Daily Clinical Practice as Second Line Treatment in Patients With Non-small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT01161173

TEAM

COMPLETED

This observational study will evaluate the safety and efficacy of Tarceva (erlotinib) in routine clinical practice as second-line treatment in patients with recurrent or metastatic non-small dell lung cancer (NSCLC). Data will be collected from patients who have received 1 course of standard systemic chemotherapy, experienced disease progression, and who are receiveingTarceva in a second-line setting. Patients will also be followed through third-line treatment if there is disease progression on Tarceva therapy.

YES

Nonsquamous Nonsmall Cell Neoplasm of Lung

DRUG: Erlotinib

Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR), Stable Disease (SD), or Progressive Disease (PD), The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. For the best overall responses of CR and PR, a response was confirmed if a subsequent RECIST evaluation also showed a CR or PR., Baseline to the end of the study (up to 4 years, 4 months)

Time to Disease Progression, The time to disease progression was defined as the time from Baseline until disease progression as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions., Baseline to the end of the study (up to 4 years, 4 months)|Progression-free Survival, Progression-free survival was defined as the time from Baseline until disease progression or death from any cause. Progressive disease was determined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions., Baseline to the end of the study (up to 4 years, 4 months)|Overall Survival, Overall survival was defined as the time from Baseline until or death from any cause, Baseline to the end of the study (up to 4 years, 4 months)|Change From Baseline in the Lung Cancer Symptom Scale (LCSS) Scores, Study participants and treating physicians completed the LCSS, a measure of Quality of Life (QoL), at Baseline and throughout the study. The patient LCSS measures 6 major symptoms, the Symptom Burden Index (SBI), associated with lung malignancies (3 thoracic [cough, dyspnea, haemoptysis] and 3 general symptoms [loss of appetite, fatigue, pain]) and 3 additional scores (overall symptomatic distress, interference with daily activities, global QoL), each on a 100 mm visual analogue scale (0=no impairment, 100=maximum impairment). The physician LCSS evaluates the 6 lung malignancy associated symptoms, the SBI, on an ordinal scale (100=none, 75=mild, 50=moderate, 25=marked, 0=severe). The average of the patient and physician SBI scores (6 symptoms) and the average of the patient total score (9 symptoms) ranged from 0 to 100, with a higher patient and a lower physician score indicating more impairment. A negative patient and a positive physician change score indicates improvement., Baseline to the end of the study (up to 4 years, 4 months)|Percentage of Participants Who Developed Rash, At each study visit, the presence of skin rash was graded using the Common Toxicity Criteria (CTC), with grade 0 = no rash, grade 1 = mild, grade 2 = moderate, grade 3 = severe, and grade 4 = life threatening or disabling rash. Reported is the percentage of participants who developed a grade ≥ 1 rash., Baseline to the end of the study (up to 4 years, 4 months)

Hoffmann-La Roche

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

ML21474

2008-04

2012-08

2012-08

2010-07-13

2016-03-28

2016-03-28

Aalst, 9300, Belgium|Antwerpen, 2020, Belgium|Arlon, 6700, Belgium|Bonheiden, 2820, Belgium|Bouge, 5004, Belgium|Boussu, 7360, Belgium|Bruxelles, 1020, Belgium|Bruxelles, 1050, Belgium|Bruxelles, 1180, Belgium|Bruxelles, 1200, Belgium|Charleroi, 6000, Belgium|Chimay, 6460, Belgium|Duffel, 2570, Belgium|Edegem, 2650, Belgium|Frameries, 7080, Belgium|Genk, 3600, Belgium|Gilly, 6060, Belgium|Hasselt, 3500, Belgium|Leuven, 3000, Belgium|Liege, 4000, Belgium|Liège, 4000, Belgium|Marche-En-Famenne, 5411, Belgium|Mons, 7000, Belgium|Namur, 5000, Belgium|Oostende, 8400, Belgium|Ottignies, 1340, Belgium|Roeselare, 8800, Belgium|Seraing, 4100, Belgium|Sint Niklaas, 9100, Belgium|Tournai, 7500, Belgium|Turnhout, 2300, Belgium|Verviers, 4800, Belgium|Vilvoorde, 1800, Belgium|Wilrijk, 2610, Belgium|Differdange, 4602, Luxembourg|Esch-alzette, Luxembourg|Luxembourg, 1210, Luxembourg

{ "Erlotinib": [ { "intervention_type": "DRUG", "description": "Erlotinib", "name": "Erlotinib", "synonyms": [ "Erlotinib", "Tarceva", "[6,7-Bis-(2-methoxy-ethoxy)-quinazolin-4-yl]-(3-ethynyl-phenyl)-amine" ], "medline_plus_id": "a605008", "generic_names": [ "Erlotinib" ], "drugbank_id": "DB00530" } ] }

NCT04403373

Effectiveness of Walking Exercise in Improving Depression in Older Adults With Major Depressive Disorder, A Pilot Study

https://clinicaltrials.gov/study/NCT04403373

COMPLETED

1. This pilot randomized controlled trial aims at investigating the effects of different intensities of aerobic walking exercise to alleviate depression in older adults with major depressive disorder. Both baseline and post-intervention measurements will be conducted at the Exercise Physiology Laboratory, Division of Kinesiology, School of Public Health, The University of Hong Kong, while the exercise intervention will be conducted outdoors in a small group setting (3-5 participants). 2. Three-time-per-week moderate-intensity (~3.5 METs) or vigorous-intensity (~7 METs) walking exercise will be prescribed to participants in two exercise groups, while the participants in the waitlist group will receive no intervention. The intervention duration is 12 weeks. 3. We will recruit participants from the community in HK. Interested participants will be invited for a semi-structured interview including an assessment on the Beck Depression Inventory and medical history record to confirm eligibility.

NO

Major Depressive Disorder (MDD)

BEHAVIORAL: Waitlist control|BEHAVIORAL: Moderate-intensity walking exercise|BEHAVIORAL: Vigorous-intensity walking exercise

Depressive symptoms-Beck Depression Inventory (BDI), BDI is a 21-item self-reporting questionnaire for evaluation of the severity of depression in both normal and psychiatric populations. Each item includes four statements numbered from 0 to 3, with a higher number indicating more severe depressive symptoms. Participants will be asked to circle the statement that can best describe them in a paper-pencil based manner. The BDI score interpretation is: less than 10: no or minimal depression, 10-18: mild-to-moderate depression, 19-29: moderate-to-severe depression, over 30: severe depression, 3 Months

Antidepressants Usage-Medication History, The use of antidepressants such as most commonly prescribed Prozac (fluoxetine), Zoloft (sertraline), Lexapro (escitalopram), Paxil (paroxetine), Celexa (citalopram), or selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, with detailed usage information (e.g., drug name, type, dosage, and frequency of dosage) will be recorded. Subjects will be asked to provide the dosage, frequency of the daily antidepressant usage. The duration between the first interview of this study and the first diagnosis of MDD will also be recorded., 3 Months|Anxiety-Generalized Anxiety Disorder 7-item (GAD-7) scale, Generalized Anxiety Disorder 7-item (GAD-7) scale will be used to measure the anxiety level of the subjects. The GAD-7 is a reliable and valid measure of anxiety severity and its brevity make the GAD-7 a useful clinical and research tool. Higher score indicates more severe level of anxiety., 3 Months|Sleep quality-Pittsburgh Sleep Quality Index (PSQI), The Pittsburgh Sleep Quality Index (PSQI) is a standardized instrument to estimate sleep quantity and quality. The PSQI has been commonly used to distinguish people with primary insomnia from normal sleepers. The Chinese version of PSQI has been validated to have a satisfactory Cronbach s alpha of 0.82-0.83 and test-retest reliability of 0.85 among Hong Kong Chinese older adults., 3 Months|Quality of life-12-item short form health survey (SF-12), SF-12 was originally developed for medical outcomes study, and it is one of the most widely used instruments for assessing health-related quality of life. SF-12 covers the same eight domains as the SF-36 form, which assesses physical functioning, emotional and mental health, body pain, general health, social functioning and vitality, with a higher score indicating a better quality of life., 3 Months|Cardiorespiratory fitness-VO2max Test, The participant s maximal oxygen consumption will be measured at baseline, 12 weeks intervention to evaluate the participants cardiovascular fitness by VO2max test using a COSMED Quark Series telemetric gas analysis system., 3 Months|Resting heart rate, The participant will be asked to sit quietly for 20 minutes for resting HR recording. The resting HR will be measured by Optical heart rate sensor (Polar OH1)., 3 Months|Body Mass Index, Body weight and height of the subject will be measured by a validated scale (A&D, UC-321) to the nearest 0.1kg and stadiometer (SECA, CE-0123) to the nearest 0.1cm. The BMI will be calculated as BMI = kg/m2., 3 Months|Daily physical activity-International Physical Activity Questionnaire (IPAQ), The Chinese version of IPAQ is one of the most reliable self-report measures of physical activity for older adults, with intraclass correlation coefficients ranging from 0.81 to 0.89. Three categories of physical activities are classified in IPAQ: Low, moderate and high. Continuous score is also suggested to be expressed as MET-min per week, which can be calculated using the data from IPAQ., 3 Months

The University of Hong Kong

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

RF-9835-MDD-007

2019-11-01

2020-12-31

2020-12-31

2020-05-27

2021-05-04

Li Kai Shing Faculty of Medicine, Hong Kong, Southern District, Hong Kong

{ "Waitlist control": [ { "intervention_type": "BEHAVIORAL" } ], "Moderate-intensity walking exercise": [ { "intervention_type": "BEHAVIORAL" } ], "Vigorous-intensity walking exercise": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT06445673

A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients

https://clinicaltrials.gov/study/NCT06445673

TripleTRE-NIS

ENROLLING_BY_INVITATION

The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study. The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial. Planned observation duration per patient is a minimum of 3 years.

NO

Pulmonary Arterial Hypertension

Time to death or lung transplantation, up to year 3|Time to first clinical worsening, clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PAH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC, up to year 3|Total number of clinical worsenings, clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC, up to year 3

Long-term change in 6MWD, 6-Minute Walking Distance (6MWD) will be measured in meters, up to year 3|Long-term change in PAH treatment regimens, any change or addition of new PH medication including dosing in time, up to year 3|Long-term change in risk status, Risk status measured by simplified four-strata risk-assessment tool, up to year 3|Long-term change in WHO FC, World Health Organization Functional Class (WHO FC) is categorized from I (no symptoms) to IV (severe dyspnea and symptoms), up to year 3|Long-term change in BDS, BDS - Borg Dyspnea Score, ranging from 0 (no exertion) to 10 (maximum), up to year 3|Long-term change in NT-proBNP/BNP, NT-proBNP/BNP: N-terminal pro Brain Natriuretic Peptide, up to year 3|Long-term change in Pulmonary Vascular Resistance (PVR), PVR to be measured in WU Parameter will be collected according to clinical routine, up to year 3|Long-term change in mean Pulmonary Arterial Pressure (mPAP), mPAP to be measured in mmHg Parameter will be collected according to clinical routine, up to year 3|Long-term change in Right Atrial Pressure (RAP), RAP to be measured in mmHg Parameter will be collected according to clinical routine, up to year 3|Long-term change in mean Right Atrial Pressure (mRAP), mean Right Atrial Pressure (mRAP) to be measured in mmHg Parameter will be collected according to clinical routine, up to year 3|Long-term change in Cardiac Index (CI), Cardiac index (CI) measured in liters per minute per square meter Parameter will be collected according to clinical routine, up to year 3|Long-term change in Cardiac Output (CO), Cardiac output (CO) measured in liters per minute Parameter will be collected according to clinical routine, up to year 3|Long-term change in Pulmonary capillary wedge pressure (PCWP), Pulmonary capillary wedge pressure (PCWP) measured in mmHg Parameter will be collected according to clinical routine, up to year 3|Long-term change in Stroke volume index (SVI), Parameter will be collected according to clinical routine, up to year 3|Long-term change in RV-PA coupling, RV-PA coupling estimated by the ratio of tricuspid annular plane systolic excursion by pulmonary artery systolic pressure Parameter will be collected according to clinical routine, up to year 3|Long-term change in RV end-diastolic area (RVEDA), RV end-diastolic area (RVEDA) measured in square centimeters Parameter will be collected according to clinical routine, up to year 3|Long-term change in RV end-systolic area (RVESA), RV end-systolic area (RVESA) measured in square centimeters Parameter will be collected according to clinical routine, up to year 3|Long-term change in RV fractional area change (RVFAC), RV fractional area change (RVFAC) calculated in % Parameter will be collected according to clinical routine, up to year 3|Long-term change in Right Atrium (RA) area, Right Atrium (RA) area in square centimeters Parameter will be collected according to clinical routine, up to year 3|Long-term change in Pericardial effusion, Pericardial effusion assessment will be done and rated as yes/no Parameter will be collected according to clinical routine, up to year 3|Long-term change in Right ventricular ejection fraction (RVEF), Parameter will be collected according to clinical routine, up to year 3

Frequency and seriousness of adverse events (AE) and adverse drug reactions (ADR), This includes: * Adverse events (S)AEs * Adverse drug reactions (S)ADRs related to any of PAH treatments * Adverse events related to underlying diagnosis, PAH, up to year 3|Long-term change in QoL using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) questionnaire, The EQ-5D-5L questionnaire consists of 2 parts - the EQ-5D-5L descriptive system and the EQ Visual Analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent s health state. It should be noted that the numerals 1-5 have no arithmetic properties and should not be used as a cardinal score., up to year 3|Long-term change in QoL using PAH-specific emPHasis-10 questionnaire, Emphasis meaning something of special importance or significance. Please translate using the most appropriate term. The PH in emPHasis represents the condition Pulmonary Hypertension. The number 10 refers to the number of items in the questionnaire. This questionnaire is designed to determine how Pulmonary Hypertension (PH) affects patient s life. It refers to how PH affects or the impact that PH has on the patient s life., up to year 3

AOP Orphan Pharmaceuticals AG

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

TREV1-10P.NIS

2024-06

2030-06

2030-06

2024-06-06

2024-06-06

Ordensklinikum Linz, Linz, Austria|Medical University Vienna, Vienna, Austria|Fakultní Nemocnice Olomouc, Olomouc, Czechia|Všeobecná fakultní nemocnice v Praze, Praha, Czechia|Hôpital Bicêtre-- Assistance Publique Hopitaux de Paris, Paris, France|Hôpitaux Universitaires de Strasbourg, Strasbourg, France|DRK Kliniken Berlin Westend, Berlin, Germany|University Hospital Carl Gustav Carus of Technical University Dresden, Dresden, Germany|Universitätsmedizin Greifswald, Greifswald, Germany|Gottsegen National Cardiovascular lnstitute, Budapest, Hungary|Medical University of Szeged, Szeged, Hungary|Sapienza University of Rome, Rome, Italy|John Paul II Hospital Krakow, Kraków, Poland|Fryderyk Chopin Hospital in European Health Centre Otwock, Otwock, Poland|Emergency Institute for Cardiovascular Diseases Prof. Dr. C.C.Iliescu, Bucharest, Romania|Emergency Clinical County Hospital of Targu Mures, Târgu-Mureş, Romania|Hospital Clinic of Barcelona, Barcelona, Spain|Hospital Ramon y Cajal, Madrid, Spain

{}

NCT05219773

Clinic Versus Home Spirometry

https://clinicaltrials.gov/study/NCT05219773

COMPAIR

UNKNOWN

The study aims to assess the differences between spirometry performed with the NuvoAir Air Next spirometer in the clinic setting with both direct and virtual supervision via a video call, and in the home setting with virtual supervision. This is will be achieved by comparing lung function values, specifically the FEV1 and FVC measurements. We also wish to evaluate participant s perceptions of home spirometry, by using a survey. This is a multi-centre, cross-over study. The study will enrol participants with a diagnosis of asthma and COPD, across participating study sites until 68 have completed the study.

NO

Asthma|Chronic Obstructive Pulmonary Disease

DEVICE: NuvoAir Air Next spirometer

1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home., Over an 8-day period; the forced expiratory volume in 1 second (FEV1) and forced vital Capacity (FVC) will be measured at 4 points in the study over the 8 day study period. Twice in clinic and twice at home., 8 days|2. To compare spirometric values obtained from two virtually supervised tests performed at home, using the NuvoAir Air Next device., The forced expiratory volume in 1 second (FEV1) and forced vital Capacity (FVC) will be measured via the NuvoAir Air Next spirometer at home at 2 points during the 8 day study period., 8 days

To evaluate the participant s views of home spirometry via a survey., A standardised survey to evaluate the participant s perception of home spirometry, will be performed., 8 days

University of Nottingham

AstraZeneca

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

288594

2021-12-14

2022-04

2022-05

2022-02-02

2022-02-02

Respiratory Research Unit, Nottingham, Nottinghamshire, NG51PB, United Kingdom|Bradford Teaching Hospitals NHS Foundation Trust, Bradford, BD9 6RJ, United Kingdom|The Rotherham NHS Foundation Trust, Rotherham, S60 2UD, United Kingdom

{ "NuvoAir Air Next spirometer": [ { "intervention_type": "DEVICE" } ] }

NCT03759873

Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program

https://clinicaltrials.gov/study/NCT03759873

HeLP

COMPLETED

Participation in outpatient cardiac rehabilitation (CR) decreases morbidity and mortality for patients hospitalized with myocardial infarction, coronary bypass surgery or percutaneous revascularization. Unfortunately, only 10-35% of patients for whom CR is indicated choose to participate. Lower socioeconomic status (SES) is a robust predictor of CR non-participation. There is growing recognition of the need to increase CR among economically disadvantaged patients, but there are almost no evidence-based interventions available for doing so. The present study will examine the efficacy of using early case management and financial incentives for increasing CR participation among lower-SES patients. Case management has been effective at promoting attendance at a variety of health-related programs (e.g. treatment for diabetes, HIV, asthma, cocaine dependence) as well as reducing hospitalizations. Financial incentives are also highly effective in altering health behaviors among disadvantaged populations (e.g., smoking during pregnancy, weight loss) including CR participation in a prior trial. For this study 209 CR-eligible lower-SES patients will be randomized to: a treatment condition where patients are assigned a case manager while in hospital who will facilitate CR attendance and coordinate cardiac care, a treatment condition where patients receive financial incentives contingent on initiation of and continued attendance at CR sessions, a combination of these two interventions, or to a usual-care condition. Participants in all conditions will complete pre- and post-treatment assessments. Treatment conditions will be compared on attendance at CR and end-of-intervention improvements in fitness, executive function, and health-related quality of life. Cost effectiveness of the treatment conditions will also be examined by comparing the costs of delivering the interventions and the usual care condition, taking into account increases in CR participation. Furthermore, the value of the interventions will be modeled based on increases in participation rates, intervention costs, long-term medical costs, and health outcomes after a coronary event. This systematic examination of promising interventions will allow testing of the efficacy and cost-effectiveness of approaches that have the potential to substantially increase CR participation and significantly improve health outcomes among lower-SES cardiac patients.

NO

Cardiac Rehabilitation

BEHAVIORAL: Incentives|BEHAVIORAL: Case Management

Cardiac Rehabilitation Attendance, Number of cardiac rehabilitation sessions completed out of a possible 36, Within 4 months of the intake assessment|Cardiac Rehabilitation Completion, Proportion of patients who complete 30+ sessions of cardiac rehabilitation, Within 4 months of the intake assessment

Change in fitness, Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Change in body composition, Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in smoking status, Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in quality of life - cardiac specific, Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in quality of life - non-specific, Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in mental health, Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in depressive symptoms, Changes in reported depressive symptoms The Beck Depression Inventory (BDI) will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in Executive Function (DD), Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in Executive Function (DS), Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in Executive Function (Trail), Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in Executive Function (BRIEF), Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Changes in Executive Function (SST), Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake)., Within 4 months of the intake assessment|Health care contacts, Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations., One year period starting at intake assessment.|Health care costs, Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations., One year period starting at intake assessment.

Maintenance of fitness following intervention., Changes in fitness level (peak oxygen uptake or METS as appropriate) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of waist circumference following intervention., Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of smoking status following intervention., Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of quality of life (cardiac-specific) following intervention., Changes in QoL(MacNew) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of quality of life (noncardiac-specific) following intervention., Changes in QoL (EuroQol) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of mental health following intervention., Changes in mental health (Adult Self-Report) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of depressive symptoms following intervention., Changes in depressive symptoms (BDI) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of Executive Function (DD) following intervention., Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of Executive Function (DS) following intervention., Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of Executive Function (BRIEF) following intervention., Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of Executive Function (SST) following intervention., Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Maintenance of Executive Function (Trail) following intervention., Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion)., From completion of intervention (4 months) to follow-up (one-year).|Cost-effectiveness, Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization., One year period starting at intake assessment.

University of Vermont

National Heart, Lung, and Blood Institute (NHLBI)

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

R61HL143305

2018-12-03

2023-05-01

2024-02-28

2018-11-30

2024-03-19

University of Vermont Medical Center, Burlington, Vermont, 05405, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT03759873/Prot_SAP_004.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT03759873/ICF_003.pdf

{ "Incentives": [ { "intervention_type": "BEHAVIORAL" } ], "Case Management": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01722773

Trial of Non-invasive Ventilation for Stable COPD

https://clinicaltrials.gov/study/NCT01722773

COMPLETED

The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded variable effects on survival, quality of life and dyspnea. The investigators hypothesized that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.

NO

COPD

DEVICE: Bipap (Respironics, Inc)

CRDQ, Chronic Respiratory Disease Questionnaire, 6 months

6-minutes walk test, Walking distances in feet, 6 months|TDI, Transitional Dyspnea Index, 6 months|PO2, Oxygenation, 6 months|NIF, Negative Inspiratory force, 6 months

Side effect questionnaire, Side effects with mask use, 6 months

University of Iowa

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

NPPV

2001-04

2004-04

2004-04

2012-11-07

2012-11-07

Univeristy of IOwa, Iowa City, Iowa, 52241, United States

{ "Bipap (Respironics, Inc)": [ { "intervention_type": "DEVICE" } ] }

NCT05493631

A Phase 1b Study to Assess the Safety, Tolerability, PK and PD of MG1113 in Hemophilia Patient

https://clinicaltrials.gov/study/NCT05493631

RECRUITING

The purpose of this study is to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of subcutaneous MG1113 in the multiple ascending dose study in patients with severe hemophilia.

NO

Hemophilia

BIOLOGICAL: MG1113

Number of subject with Adverse events, Adverse Drug Reactions, Serious adverse events and Adverse event of special interest (AESI), Through study completion (Study Day 1 to Day 78 visit)|Incidence of Adverse events, Adverse Drug Reactions, Serious adverse events and Adverse event of special interest (AESI), Through study completion (Study Day 1 to Day 78 visit)|Severity of Adverse events, Adverse Drug Reactions, Serious adverse events and Adverse event of special interest (AESI), Through study completion (Study Day 1 to Day 78 visit)|Incidence of injection site reaction, Study Day 1 to Day 57 visit|Severity of injection site reaction, Study Day 1 to Day 57 visit|Number of subjects with abnormal Physical examination, Through study completion (Study Day 1 to Day 78 visit)|Number of subjects with abnormal 12-lead ECG (Ventricular rate in beat/min, Interval for PR in msec, QRS in msec, QTc in msec), Through study completion (Study Day 1 to Day 78 visit)|Number of subjects with abnormal Vital signs (Blood pressure in mmHg, Pulse rate in beats/min, Respiration rate in breaths/min, Body temperature in ℃), Through study completion (Study Day 1 to Day 78 visit)|Incidence of clinically significant laboratory value abnormalities, Through study completion (Study Day 1 to Day 78 visit)

Pharmacokinetic assessment - Cmax (Peak plasma concentration), Through study completion (Study Day 1 to Day 78 visit)|Pharmacokinetic assessment - Cmin (Minimum plasma concentration), Through study completion (Study Day 1 to Day 78 visit)|Pharmacokinetic assessment - AUC (Area under the plasma concentration versus time curve), Through study completion (Study Day 1 to Day 78 visit)|Pharmacokinetic assessment - Tmax (Time to maximum plasma concentration after administration), Through study completion (Study Day 1 to Day 78 visit)|Pharmacokinetic assessment - half-life (T1/2; the time required to reduce the plasma concentration by half), Through study completion (Study Day 1 to Day 78 visit)|Pharmacokinetic assessment - CL/F (apparent clearance), Through study completion (Study Day 1 to Day 78 visit)|Pharmacokinetic assessment - Vd/F (apparent volume of distribution), Through study completion (Study Day 1 to Day 78 visit)|Pharmacokinetic assessment - Accumulation Index (AUCtau_multiple dose/AUCtau_single dose), Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Free TFPI in plasma in ng/mL, Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Residual TFPI activity in unit/mL, Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Diluted PT in sec, Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Thrombin generation (Lag time in min), Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Thrombin generation (Peak generation in nM), Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Thrombin generation (Endogenous thrombin generation potential [ETP] in nM*min), Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Pro-coagulant effect (D-dimer in ug/mL), Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Pro-coagulant effect (Fibrinogen in mg/dL), Through study completion (Study Day 1 to Day 78 visit)|Pharmacodynamic assessment - Pro-coagulant effect (Prothrombin fragments 1+2 in pmol/L), Through study completion (Study Day 1 to Day 78 visit)|Immunogenicity assessment - Any formation of anti-drug antibody (ADA) to MG1113, Through study completion (Study Day 1 to Day 78 visit)|Efficacy Evaluation - Incidence of new bleeding episode, Study Day 1 to Day 57 visit

GC Biopharma Corp

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

MG1113_HP_P0101

2022-08-24

2024-07-31

2024-12-31

2022-08-09

2022-08-25

GC Biopharma Corp., Yongin-si, Gyeonggi-do, 16924, Korea, Republic of

{ "MG1113": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT02208973

Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF-680 After Multiple Oral Doses

https://clinicaltrials.gov/study/NCT02208973

COMPLETED

To assess the safety and tolerability of five doses of PBF-680 (5 mg, 10 mg, 20 mg, 40 mg and 60mg) after repeated (8 days) single daily oral dose administration in young male and female healthy subjects.

NO

Asthma

DRUG: PBF-680|DRUG: Placebo

Number of Participants with Serious and Non-Serious Adverse Events, Vital Signs, ECG recordings, laboratory safety test and phisical examination will be performed, from day 0 to day 15

Pharmacokinetic Profile Analysis (Plasma concentrations), * Day 1: baseline [pre-dose], [+10 min], [+20 min], [+40min], [+60min], [+ 1.5h], [+2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+8h], [+ 12h] and [+16h] post-medication; * Days 2 to 7: baseline [daily pre-dose] which corresponds at +24h of previous dose; * Day 8: baseline [daily pre-dose], [+10 min], [+20 min], [+40min], [+60min], [+1.5h], [+2 h], [+ 2.5 h], [+ 3 h], [+ 4h], [+8h], [+ 12h] and [+16h] and [+ 24h] post-daily medication (D9)., from day 1 to day 8

Adenosine A1 receptor antagonism activity, day 1 and day 8|Leeds Sleep Evaluation Questionnaire, from day 1 to day 8

Fundació Institut de Recerca de l Hospital de la Santa Creu i Sant Pau

Palo Biofarma, S.L

ALL

ADULT

PHASE1

OTHER

INTERVENTIONAL

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

IIBSP-PBF-2014-04|2014-000425-20

2014-05

2014-10

2014-12

2014-08-05

2016-03-08

Palobiofarma S.L. (molecule owner), Mataró, Barcelona, 08302, Spain|CIM-Sant Pau - IIB Sant Pau, HSCSP, Barcelona, 08025, Spain

{ "PBF-680": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT00556231

Multi-site Near Infrared Spectroscopy (NIRS) Monitoring of Children During Exercise

https://clinicaltrials.gov/study/NCT00556231

COMPLETED

Near Infrared Spectroscopy (NIRS) monitoring has proven beneficial in increasing safety and improving patient care during pediatric cardiac surgery and during Pediatric Intensive Care Unit (PICU) stays. NIRS estimates the amount of oxygen in tissues by comparing the tissue s absorption of two wavelengths of light corresponding to hemoglobin carrying oxygen and hemoglobin without oxygen. During cardiac surgery, multi-site NIRS monitoring is used to determine the heart s output by comparing the amount of oxygen available to discrete regions of the body nourished by different parts of the circulatory system. NIRS leads placed on the forehead detect oxygen available to the brain (cerebral), while leads placed over the kidney reflect oxygen available to the internal organs (somatic). NIRS monitoring has been used for studying muscle oxygen usage during exercise in normal and disease states. Cerebral oxygenation at peak exercise at has been studied with NIRS monitoring. The use of multi-site NIRS monitoring during exercise stress testing for studying cardiac output through the patterning of somatic and cerebral oxygenation in combination with exercise stress test data has not been researched. We hypothesize that addition of multi-site NIRS monitoring to the standard data collection already achieved during exercise testing, will enable calculation of anaerobic threshold and cardiac output prediction. This will assist in determining appropriate timing for surgical intervention, predicting the post operative course and testing response to medication.

NO

Congenital Heart Disease

regional oxygen saturations in 4 sites, during exercise stress testing

Medical College of Wisconsin

Children s Hospital and Health System Foundation, Wisconsin

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

CHW 0.04

2007-11

2012-12

2012-12

2007-11-09

2013-01-04

Children s Hospital of Wisconsin, Milwaukee, Wisconsin, 53226, United States

{}

NCT05323331

Circuit Training Program in Post COVID-19 Patients

https://clinicaltrials.gov/study/NCT05323331

COMPLETED

The objective of this study will be to compare the effects of Circuit Training Program on Cardiopulmonary Parameters and Functional Capacity in Post COVID 19 patients. This study will be a Randomized Clinical trial. Data will be collected from Boston Physiotherapy and Wellness Clinic, Lahore. One group will receive Circuit Training and other group will receive Aerobic Exercises. All subjects will receive a total of three treatment sessions per week over the period of 12 weeks. Outcome will be measured at baseline, 6th week and 12th week with 6 Minute Walk Test (6MWT), Rate of Perceived Exertion (RPE 6-20), Spirometer for PFT and Post-Covid 10 Functional Status Scale.The data will be analyse using SPSS v 25.

NO

COVID-19

OTHER: Circuit Training Exercise Program|OTHER: Aerobic Training Exercise Program

6 Minutes Walk Test, A simple 6 minutes walk test (6MWT) is a reliable tool to assess cardiorespiratory effort tolerance in chronic lung and chronic heart failure patients. The test provides a global assessment of the cardio pulmonary reserves, Baseline|6 Minutes Walk Test, A simple 6 minutes walk test (6MWT) is a reliable tool to assess cardiorespiratory effort tolerance in chronic lung and chronic heart failure patients. The test provides a global assessment of the cardio pulmonary reserves, 6th Week of Treatment|Rate of Perceived Exertion (RPE 6-20):, The Borg Rating of Perceived Exertion (RPE) scale is a subjective assessment of how hard someone feels they are working and can be helpful to guide people in choosing what activities to do as they progress through the phases of increasing physical activity., Baseline|Rate of Perceived Exertion (RPE 6-20):, The Borg Rating of Perceived Exertion (RPE) scale is a subjective assessment of how hard someone feels they are working and can be helpful to guide people in choosing what activities to do as they progress through the phases of increasing physical activity., 6th Week of Treatment|Post-Covid Functional Status Scale (PCFS), An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19, Baseline|Post-Covid Functional Status Scale (PCFS), An ordinal tool that is proposed to measure the full spectrum of functional outcomes following COVID-19, 6th Week of Treatment

Riphah International University

ALL

ADULT

OTHER

INTERVENTIONAL

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

RiphahIU Hira Haumayun

2022-04-01

2022-10-01

2022-12-01

2022-04-12

2023-01-05

Riphah Rehabiliation Clinic, Lahore, Punjab, 54770, Pakistan

{ "Circuit Training Exercise Program": [ { "intervention_type": "OTHER" } ], "Aerobic Training Exercise Program": [ { "intervention_type": "OTHER" } ] }

NCT01812031

Benefits Study of Respiratory-gated PET Acquisition in Lung Disease

https://clinicaltrials.gov/study/NCT01812031

PneumoTEP

COMPLETED

Fluorodeoxyglucose (FDG) positron emission tomography (PET) is now widely used for cancer imaging purpose, notably for preoperative work-up. It aims at visualizing organs metabolism. In case of cancer, metabolism is, classically, increased and some hot spots are visible on PET images. Because of respiratory motion some lung tumours (especially the smallest ones) can be falsely interpreted by the clinician. The investigators developed a respiratory-gated PET method in order to reduce the motion issue. The investigators designed a study to investigate its effect on lung cancer (primary or metastasis) to check if it improves the sensitivity/specificity of PET imaging of the lungs. To that aim, patients presenting a lung nodule on a CT examination can be proposed to participate this study. After the standard PET acquisition (acquired in free-breathing), an additional 10 minutes respiratory-gated PET acquisition is performed without additional injection. After that, a breath-hold (~10s) CT is performed.

NO

Lung Cancer|Non Small Cell Lung Cancer|Chronic Obstructive Pulmonary Disease

OTHER: medical imaging

Lesion SUVmax, For each CT nodule, observer has to report the corresponding (maximum Standardized Uptake Value)SUVmax on ungated and CT-based images (even if there is no obvious uptake), Day 1

Lung function test, Patients undergo lung function test including measures of: * total lung capacity * residual volume * forced expiratory volume * forced vital capacity, Day 0

Centre Hospitalier Universitaire, Amiens

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: DIAGNOSTIC

AOL09-PR-MEYER|2009-A00491-56

2009-08

2013-02

2015-02

2013-03-15

2015-02-27

CHU Amiens, Amiens, Picardie, 80054, France

{ "medical imaging": [ { "intervention_type": "OTHER" } ] }

NCT00787631

Analysis of Immunological Reactions to Foods in Birch Pollen-Allergic Patients

https://clinicaltrials.gov/study/NCT00787631

UNKNOWN

A high number of birch pollen-allergic individuals develop hypersensitivity reactions to certain foods, e.g. apples. This food allergy is due to immunological cross-reactivity. Birch pollen-related foods contain proteins, e.g. Mal d 1 in apple, that are structurally related with the major birch pollen allergen, Bet v 1. Hence IgE antibodies and T lymphocytes specific for Bet v 1 recognize these food proteins which results in activation of the immune system and, consequently, in clinical symptoms. In the present study the investigators intend to investigate if and how the consumption of birch pollen-related food allergens affects birch pollen allergy. In other words, the investigators are interested to analyse whether Bet v 1-related food allergens activate Bet v 1-specific memory cells and thus, contribute to the maintenance of the pollen allergy outside the pollen season. Data obtained in this study will help to clarify the immunological and clinical role of cross-reactivity between pollen and food allergies and will reveal whether avoidance of such foods should be recommended for the patients. Finally, novel approaches for diagnosis and therapy of pollen-related food allergens can be developed.

NO

Allergic Rhinitis|Food Allergy

Medical University of Vienna

ALL

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

TK01/2008

2008-12

2010-01

2010-12

2008-11-07

2008-11-07

{}

NCT01794273

Compared Efficacy and Tolerance of Two Vasopressors Used to Treat Preoperative Hypotension During Carotid Surgery

https://clinicaltrials.gov/study/NCT01794273

VP-hTA-XCar

COMPLETED

The effects on brain perfusion of the two currently vasopressors used to treat accidental hypotension occurring during carotid surgery (i.e. ephedrine and phenylephrine) is not known, but a disadvantage to use phenylephrine is suspected, due to its mechanism of action and according to published reports

NO

Endovascular Carotid Surgery|Preoperative Hypotension

DRUG: ephedrine and phenylephrine

Cerebral oxygen saturation (SctO2), at day 1

Incidence of post-treatment hypotension, At day 1|Incidence of post-treatment bradycardia, at day 1|Postoperative morbidity: cardiovascular, cerebral, renal, surgical, at day 1|Postoperative recovery, at day 1

University Hospital, Clermont-Ferrand

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

CHU-0147|2012-001827-11

2012-07

2013-07

2013-12

2013-02-18

2018-09-24

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

{ "Phenylephrine": [ { "intervention_type": "DRUG", "description": "ephedrine and phenylephrine", "name": "Phenylephrine", "synonyms": [ "Metasympatol", "Little Noses", "Suphedrin PE", "Neosynephrine", "PediaCare Children's Decongestant", "Phenylephrine Tannate", "l-(3-Hydroxyphenyl)-N-methylethanolamine", "Fenilefrina", "(\u2212)-m-hydroxy-\u03b1-(methylaminomethyl)benzyl alcohol", "Neo Synephrine", "Tannate, Phenylephrine", "Phenylephrinum", "Phenylephrine", "Phenylephrine Hydrochloride", "Metaoxedrin", "Neo-Synephrine", "Children's Sudafed PE Nasal Decongestant", "(R)-3-Hydroxy-alpha-((methylamino)methyl)benzenemethanol", "Mezaton", "R(-)-Phenylephrine" ], "medline_plus_id": "a616049", "generic_names": [ "Phenylephrine" ], "mesh_id": "D058646", "drugbank_id": "DB00388" } ] }

NCT02306473

The Leaky Lung Test

https://clinicaltrials.gov/study/NCT02306473

COMPLETED

This is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.

NO

Asthma|Allergy|Reactive Airway Disease|Lung Diseases, Obstructive

DRUG: Mannitol

Airway permeability index (Urinary clearance of mannitol overtime), Urinary clearance of mannitol overtime, 24 hours

Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream), Absorption and clearance of mannitol from the bloodstream, 6 hours

University of Rochester

National Institutes of Health (NIH)|Syntara|National Heart, Lung, and Blood Institute (NHLBI)

ALL

ADULT, OLDER_ADULT

EARLY_PHASE1

OTHER

INTERVENTIONAL

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

RSRB00043414|R01HL122424

2015-10

2017-12-01

2017-12-01

2014-12-03

2018-01-04

University of Rochester Medical Center, Rochester, New York, 14642, United States

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

NCT05490173

The Pilot Experimental Study of the Neuroprotective Effects of Exosomes in Extremely Low Birth Weight Infants

https://clinicaltrials.gov/study/NCT05490173

NOT_YET_RECRUITING

To study the safety and efficacy of intranasal administration of exosomes derived from mesenchymal stromal cells on long-term neurodevelopmental outcome in extremely low birth weight infants born at gestational age 25/0-27/6 weeks.

NO

Premature Birth|Extreme Prematurity|Preterm Intraventricular Hemorrhage|Hypoxia-Ischemia, Cerebral|Neurodevelopmental Disorders

OTHER: Exosomes derived from mesenchymal stromal cells (MSCs)

Occurrence and rate of dose limiting toxicity, Dose limiting toxicity consists of the following events: Death occurring within 24 hours after intranasal administration of EVs; Hypersensitivity / anaphylactic to EVs defined as any severe systemic inflammatory response syndrome with negative blood culture not consistent with the overall clinical course of the infant occurring within 72 hours after intranasal administration of EVs; Any other serious adverse event not expected in this patient population for which there is no alternative explanation but the administration of EVs, occurring within 1 week of injection., Up to 1 week following after intranasal administration of EVs

Rate of death, Rate of death until discharge or 40 weeks corrected gestational age, whichever comes first, From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)|Occurrence of Other Severe Complications of Prematurity, * Blood culture-proven sepsis * Patent ductus arteriosus (treated medically or surgically) * Necrotizing enterocolitis * Isolated intestinal perforation * Retinopathy of prematurity requiring treatment * Severe intraventricular hemorrhage (≥ grade 3) * Cystic periventricular leukomalacia * Incidence and Severity of BPD, Measured as mild, moderate, or severe, From enrollment until discharge or 40 weeks corrected gestational age (whichever occurs first)|Need for Ventilatory Support, * Time to extubation * Duration of mechanical ventilation * Duration of non-invasive positive pressure respiratory support * Duration of supplemental oxygen, From enrollment until discharge, 40 weeks corrected gestational age, or death (whichever occurs first)|Changes in Hemodynamics, Targeted neonatal echocardiography to assess, Time Frame: At enrollment, 48 hours following intranasal administration of EVs, 28 days of life, and 36 weeks corrected gestational age|Feasibility: Administration, Successful recruitment and administration of extracellular vesicles to 10 patients in 18 months, Day of life 1-10|Feasibility: Recruitment Efficiency, * Proportion of potentially eligible patients that are successfully screened * Proportion of participants successfully screened who do not enroll (reason for failure to enroll will be recorded), Day of life 1-10|Feasibility: Recruitment Timing, * Median time from screening to enrollment * Median time from screening to extracellular vesicles, Day of life 1-10|Feasibility: Participant Retainment, * Proportion of patients that do not complete administration of extracellular vesicles * Proportion of patients enrolled that do not undergo scheduled follow-up, From enrollment until follow-up at 18-36 months-of-age|Griffiths-II and Bayley Scales of Infant Development (2nd edition), Assessment of cognitive, language, and motor development. Cognitive delay defined as mental developmental index (MDI) score of the Griffiths-II and Bayley Scales of Infant Development (2nd edition) < 85, cerebral palsy, or severe visual or hearing impairment., 18-36 months-of-age|Long-term Safety Follow-Up, Participant s overall health will be assessed through a questionnaire administered over the phone, once a year for 3 years, 3 years following follow-up visit

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare

ALL

CHILD

OTHER_GOV

INTERVENTIONAL

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

ncagp4382277

2022-10-05

2026-05-22

2026-12-28

2022-08-05

2022-09-28

Federal State Budget Institution Research Center for Obstetrics, Gynecology and Perinatology Ministry of Healthcare, Moscow, 117997, Russian Federation

{ "Exosomes derived from mesenchymal stromal cells (MSCs)": [ { "intervention_type": "OTHER" } ] }

NCT01187173

The Fibrosis-Lymphedema Continuum in Head and Neck Cancer

https://clinicaltrials.gov/study/NCT01187173

COMPLETED

Goal: The primary goal of this study is to longitudinally investigate, in head and neck cancer (HNC) patients, the potential fibrosis-lymphedema continuum. Specifically, we will examine the development, patterns, progression, and prevalence of late-effect fibrosis and/or lymphedema, explore potential biological correlatives including pro-inflammatory cytokines and genetic polymorphisms, and evaluate the relationship among late-effect fibrosis and/or lymphedema and select psychosocial stressors that potentially interact with cytokine pathways. H: A minimum of 20 percent of HNC patients will experience late-effect fibrosis and/or lymphedema. H: We will be able to differentiate characteristics patterns of the development of late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of symptoms associated with late-effect fibrosis and/or lymphedema. H: We will be able to differentiate patterns of inflammatory response and the development of late-effect fibrosis and/or lymphedema. H: Select polymorphisms will increase the likelihood of development of late-effect fibrosis and/or lymphedema. H: Incidence and severity of late-effect fibrosis and/or lymphedema will correlate with total dose of radiation to involved anatomical site. H: HNC patients with fibrosis and/or lymphedema experience greater levels of depression and social withdrawal than those without these conditions.

NO

Head and Neck Neoplasms|Fibrosis|Lymphedema|Biomarkers|Polymorphism, Genetic|Depression

Prevelence and nature of fibrosis and/or lymphedema, baseline, every six wks. first year pot-tx, and 15 & 18 mths post tx.|Relationships among biological mechanisms of fibrosis and/or lymphedema, baseline, every 6 weeks after tx. for one year, and 15 and 18 months after tx.|Relationship of fibrosis and/or lymphedema and psychosocial stressors, baseline, every 6 weeks post tx for 1 year and 15 and 18 months post tx.

Vanderbilt University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

100475

2010-07

2014-11

2014-11

2010-08-23

2017-04-10

Vanderbilt Ingram Cancer Center, Nashville, Tennessee, 37232, United States

{}

NCT00482573

Dental Anesthesia in Pregnant Women With Rheumatic Heart Disease

https://clinicaltrials.gov/study/NCT00482573

COMPLETED

The hemodynamic parameters of 31 pregnant women with rheumatic valve disease, undergoing restorative dentistry under local anesthesia with 2% solution of lidocaine, divided in two groups, with (Group LE) and without 1:100,000 epinephrine solution (Group LNE), were studied by 24-hour ambulatory electrocardiographic monitoring, intermittent blood pressure monitoring and continuous cardiotocography, during three standard time periods. A significant decrease in the values of maternal heart rate was seen during the procedure, in comparison with the other two time periods in the two groups, as well as, the occurrence of cardiac arrhythmia in 9 (29.1%) patients, being 7 (41.8%) of them in the group receiving epinephrine anesthesia. We conclude the use of 2% lidocaine in association with epinephrine proved safe during dental procedure in pregnant women with rheumatic valve disease.

NO

Rheumatic Heart Disease|Pregnancy|Dental Caries

PROCEDURE: Dental local anesthesia|PROCEDURE: Dental local anesthesia

Maternal: Blood Pressure, Heart Rate and Extrasystoles; Maternal-Fetal: Fetal Heart Rate, number of uterine contractions, motility and fetal reactivity pattern, in function of presence or not of epinephrine 1:100000 in the 2% solution.of lidocaine, 4 periods Maternal: (1) Baseline - 60 minutes before the procedure, (2) Procedure, (3) Post-Procedure - 20 minutes, and (4) mean 24-hour; 3 periods Maternal-Fetal: (1) Baseline: 20 minutes before, (2) Procedure, and (3) Post-Procedure - idem maternal

They had been the same analyses used for the Primary Outcome Measures, in function of the gestational age (GA): sub-group GA1 (15 pregnant women between 28 and 31 weeks) and sub-group GA2 (16 pregnant women between 28 and 31 weeks)., They had been the same periods established for the Time Frame of Primary Outcome Measure

University of Sao Paulo

Fundação de Amparo à Pesquisa do Estado de São Paulo

FEMALE

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

CAPPesq 009/03

2004-04

2005-07

2006-01

2007-06-05

2008-06-05

Heart Institute (InCor) of University of São Paulo Medical School, Sao Paulo, SP 05403-000, Brazil

{ "Dental local anesthesia": [ { "intervention_type": "PROCEDURE" }, { "intervention_type": "PROCEDURE" } ] }

NCT02400073

AutoSet for Her Quality of Life Clinical Trial

https://clinicaltrials.gov/study/NCT02400073

FEM-PAP

COMPLETED

Obstructive sleep apnea (OSA) has detrimental effects on the health and quality of life of suffers. Recent literature has shown that females may be particularly susceptible to adverse the quality of life effects, and that female obstructive sleep apnea manifests differently than male obstructive sleep apnea. A new AutoSetting Positive Airway Pressure (PAP) device has been designed specifically to treat female OSA. In this Cohort study, female patients who are newly diagnosed with OSA will be asked to complete various questionnaires relating to their quality of life. Patients will then use the AutoSet for Her for three months. At the completion of the three months the questionnaires will be repeated. Before treatment and after treatment quality of life will be compared to determine if treating female specific OSA in these patients improves quality of life.

YES

Obstructive Sleep Apnea

DEVICE: AutoSet for Her

Assessment of Quality of Life Using the Functional Outcomes of Sleep Questionnaire (FOSQ), The Functional Outcomes of Sleep Questionnaire (FOSQ) assesses quality of life based on self reported physical and mental health. The outcome measure is Change from Baseline FOSQ score at 3 months. The minimum score is 5 and the maximum score is 20. Higher scores represent a better outcome, 3 months

Sleep Changes Assessed Through Polysomnography, assessment of sleep quality (sleep efficacy, amounts of deep sleep, amounts of REM sleep). The outcome measure is changes in sleep from baseline at 3 months, 3 months

ResMed

FEMALE

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

MA230315

2015-03-19

2017-01-05

2019-08-07

2015-03-26

2019-10-02

2019-10-02

Sleep and Ventilation Center, Blaubeuren, Ulm, Germany|Advanced Sleep Research GmbH, Berlin, 10117, Germany|Hospital Universitario de Valme., Sevilla, 41014, Spain

{ "AutoSet for Her": [ { "intervention_type": "DEVICE" } ] }

NCT06027073

Biologics and Sublingual Immunotherapy

https://clinicaltrials.gov/study/NCT06027073

BSIPL

NOT_YET_RECRUITING

Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy s effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.

NO

Asthma, Allergic

BIOLOGICAL: omalizumab

Assess the effectiveness of combined therapy : omalizumab+ immunotherapy, Daily dose of inhaled steroids (changes), 3 years

Medical University of Silesia

Centrum Medyczne Andrzej Bożek

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

CM-01966

2024-05-01

2026-10-01

2028-03-01

2023-09-07

2023-09-07

{ "Omalizumab": [ { "intervention_type": "BIOLOGICAL", "description": "omalizumab", "name": "Omalizumab", "synonyms": [ "Omalizumab", "Xolair" ], "medline_plus_id": "a603031", "generic_names": [ "Omalizumab" ], "mesh_id": "D018927", "drugbank_id": "DB00043", "wikipedia_url": "https://en.wikipedia.org/wiki/Omalizumab" } ] }

NCT04542473

Pancreatic Enzymes and Bile Acids in Acutely Ill Severely Malnourished Children

https://clinicaltrials.gov/study/NCT04542473

PB-SAM

ACTIVE_NOT_RECRUITING

Children with severe malnutrition who are sick and admitted to hospitals have high mortality, usually because of infection. Malnourished children have more potentially harmful bacteria in their upper intestines than well-nourished children and this may contribute to inflammation in the gut and whole body. These bacteria may cross from the intestines to the bloodstream causing life-threatening infections. A related abnormality among malnourished children is reduction in the digestive enzymes made by the pancreas and the liver. Apart from helping with digestion of food, these enzymes are important in helping the body control bacteria in the upper intestines. It is therefore possible that treatment with digestive enzymes could help reduce the burden of harmful bacteria and thus lower inflammation and the risk of serious infection. One study conducted in Malawi has shown that children with severe malnutrition who were supplemented with pancreatic enzymes had a lower risk of dying. However, this was a small study and although promising, requires validation. No studies of supplementation with bile acids have been done among severely malnourished children. However, bile acids are commonly used to manage patients with liver function abnormalities, something that malnourished children suffer from as well. The investigators want to find out if supplementing these pancreatic enzymes and bile acids among ill children with severe acute malnutrition is safe and reduces the risk of death, deterioration or readmission to hospital.

NO

SEPSIS|MALNUTRITION, CHILD

DRUG: Pancreatic Enzyme|DRUG: Ursodeoxycholic acid|OTHER: Pancreatic Enzyme placebo|OTHER: Ursodeoxycholic acid placebo

Mortality, Death, 60 days

Rate of SAEs, All serious adverse events, 60 days|Rate of toxicity events, Grade 3 or 4 toxicity events whilst receiving investigational products, 21 days|Intestinal function, number of days with diarrhoea during index hospital admission, 60 days|Antimicrobials, Days on second and third-line antibiotics during index admission and readmission, 60 days|Hospitalisation duration, Number of days from enrolment to discharge during index admission, 60 days|Growth - arm circumference cm, Change in MUAC in cm between enrolment and 60 days later, 60 Days|Growth - weight for age z score, Change in weight for age z score between enrolment and 60 days later, 60 days|Growth - weight for length z score, Change in weight for length z score between enrolment and 60 days later, 60 days|Growth - length for age z score, Change in length for age z score between enrolment and 60 days later, 60 days

University of Oxford

University of Amsterdam|University of Toronto|University of Washington|Oregon Health and Science University|Kenya Medical Research Institute|Queen Elizabeth Central Hospital, Blantyre, Malawi|Makerere University|KEMRI-Wellcome Trust Collaborative Research Program|International Centre for Diarrhoeal Disease Research, Bangladesh

ALL

CHILD

PHASE2|PHASE3

OTHER

INTERVENTIONAL

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

OxTREC 43-20

2021-07-01

2023-10-31

2024-06-30

2020-09-09

2023-02-24

ICDDR,B Dhaka Hospital, Dhaka, Bangladesh|KEMRI WT Clinical Trials Facility, Kilifi, 80800, Kenya|Queen Elizabeth Central Hospital, Blantyre, Malawi|Mulago Hospital, Kampala, Uganda

{ "Pancreatic Enzyme": [ { "intervention_type": "DRUG" } ], "Ursodiol": [ { "intervention_type": "DRUG", "description": "Ursodeoxycholic acid", "name": "Ursodiol", "synonyms": [ "Urso", "UDCA", "Acido ursodeossicolico", "Ursodeoxycholic acid", "Acidum ursodeoxycholicum", "3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid", "Ursodeoxycholate", "(3\u03b1,5\u03b2,7\u03b2)-3,7-dihydroxycholan-24-oic acid", "Ursodiol", "Acide ursodesoxycholique", "Actigall", "Acido ursodeoxicolico", "(3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid" ], "medline_plus_id": "a699047", "generic_names": [ "Ursodeoxycholic acid", "Ursodiol" ], "drugbank_id": "DB01586", "wikipedia_url": "https://en.wikipedia.org/wiki/Ursodeoxycholic%20acid" }, { "intervention_type": "OTHER", "description": "Ursodeoxycholic acid placebo", "name": "Ursodiol", "synonyms": [ "Urso", "UDCA", "Acido ursodeossicolico", "Ursodeoxycholic acid", "Acidum ursodeoxycholicum", "3alpha,7beta-Dihydroxy-5beta-cholan-24-oic acid", "Ursodeoxycholate", "(3\u03b1,5\u03b2,7\u03b2)-3,7-dihydroxycholan-24-oic acid", "Ursodiol", "Acide ursodesoxycholique", "Actigall", "Acido ursodeoxicolico", "(3alpha,5beta,7beta)-3,7-dihydroxycholan-24-oic acid" ], "medline_plus_id": "a699047", "generic_names": [ "Ursodeoxycholic acid", "Ursodiol" ], "drugbank_id": "DB01586", "wikipedia_url": "https://en.wikipedia.org/wiki/Ursodeoxycholic%20acid" } ], "Pancreatic Enzyme placebo": [ { "intervention_type": "OTHER" } ] }

NCT02002273

Effect of Regulated Pleural Pressure on Air Leak and Fluid Drainage Following Pulmonary Resections: A Multicenter Randomized Trial

https://clinicaltrials.gov/study/NCT02002273

WITHDRAWN

The objective of this randomized study is to compare the effect of two controlled chest tube protocols on the duration of air leak and fluid drainage following pulmonary lobectomy or segmentectomy by using an electronic regulated chest drainage system (Thopaz). Previous studies have suggested that the amount of negative pressure used at the level of the chest drainage device may affect the duration of air leak, but the results have been inconsistent, however as revealed in more recent studies understanding of the physics of chest drainage devices may have been confounded by lack of regulation of the pleural pressure. In addition, experimental studies have shown that fluid drainage may be affected by the degree of negative pleural pressure applied.

NO

Lung Cancer

PROCEDURE: Switching level of suction

duration of air leak, up to 7 days

1. Differences in airflow detected during the 4 hours after the pressure level is switched to -8 cmH2O or -20 cmH2O compared to the original pressure level in both groups, up to 5 days|Differences in fluid drainage, up to 5 days|Duration of chest tube left in the patient (days), up to 7 days|Postoperative length of hospital stay (days), up to 7 days

Ospedali Riuniti Ancona

The Leeds Teaching Hospitals NHS Trust|Yale University|The University of Hong Kong

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

Airleak-2013-1

2014-01

2016-01

2016-01

2013-12-05

2016-03-29

Ospedali Riuniti Ancona, Ancona, Italy

{ "Switching level of suction": [ { "intervention_type": "PROCEDURE" } ] }

NCT02419573

Pragmatic Airway Resuscitation Trial

https://clinicaltrials.gov/study/NCT02419573

PART

COMPLETED

The primary objective of the trial is to determine if 72-hour survival after out-of-hospital cardiac arrest (OHCA) is improved with initial endotracheal intubation (ETI) over initial laryngeal tube (LT) airway management strategies.

YES

Cardiac Arrest

DEVICE: Endotracheal Intubation|DEVICE: Laryngeal Tube (King)

Number of Patients Alive at 72 Hours After Episode., Number of patient alive at 72 hours after episode., 72 hours

Return of Spontaneous Circulation (ROSC), Presence of palpable pulses on Emergency Department arrival. Patients pronounced dead in the field coded as ROSC=[none]., Patients will be followed from the time of the CA until death or ROSC whichever occurs first. The time frame for this secondary outcome may vary from minutes to hours, but is not expected to last longer than 12 hours.|Number of Patients Alive at Hospital Discharge, Number of patients alive at time hospital discharge., From enrollment through end of hospital course. Maximum time interval not specified. Maximum time interval observed in study was 138 days.|Number of Patients With Favorable Neurologic Status on Hospital Discharge, Number of patients with favorable neurologic status, defined as Modified Rankin Scale (MRS) <=3. MRS values for neurologic outcome include: 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead., From enrollment through end of hospital course.

University of Alabama at Birmingham

National Heart, Lung, and Blood Institute (NHLBI)|American Heart Association|The University of Texas Health Science Center, Houston

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

HL077863-PART|5U01HL077863|UH2HL125163

2015-12-01

2017-12-01

2017-12-01

2015-04-17

2018-12-12

2019-01-14

Alabama Resuscitation Center, Birmingham, Alabama, 35294, United States|Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University, Portland, Oregon, 92739, United States|The Pittsburgh Resuscitation Network, University of Pittsburgh, Pittsburgh, Pennsylvania, 15261, United States|Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Cente, Dallas, Texas, 75390, United States|University of Washington (Data Coordinating Center), Seattle, Washington, 98115, United States|Milwaukee Resuscitation Network, Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT02419573/Prot_SAP_000.pdf

{ "Endotracheal Intubation": [ { "intervention_type": "DEVICE" } ], "Laryngeal Tube (King)": [ { "intervention_type": "DEVICE" } ] }

NCT04438473

Pectin Supplemented Enteral Feedings in Critically Ill Patients

https://clinicaltrials.gov/study/NCT04438473

WITHDRAWN

The current study will enroll critically ill patients who are going to require enteral nutrition support and randomize them to standard formula enteral nutrition or pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related complications will be recorded and compared between groups. The study is trying to assess whether the use of pectin will improve the enteral nutrition-related complications in critically ill patients.

NO

Enteral Nutrition|Dietary Fiber

DIETARY_SUPPLEMENT: pectin-supplemented enteral nutrition feeding|OTHER: enteral nutrition feeding

Complication of enteral feeding, Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying, 7 days

feeding time of enteral nutrition, Record daily feeding time of enteral nutrition, 7 days|total energy intake, Record daily energy intake, 7 days

Second Affiliated Hospital, School of Medicine, Zhejiang University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2019-112

2020-07-30

2020-12-01

2021-12-01

2020-06-18

2021-07-15

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, 310009, China|Huzhou central hospital, Huzhou, Zhejiang, 313003, China|The first hospital of Jiaxing, Jiaxing, Zhejiang, 314001, China|Jinhua municipal central hospital, Jinhua, Zhejiang, 321000, China|Quzhou Kecheng People s Hospital, Quzhou, Zhejiang, 324000, China|Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang, 317099, China|The first affiliated hospital of Wenzhou medical university, Wenzhou, Zhejiang, 325000, China

{ "pectin-supplemented enteral nutrition feeding": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "enteral nutrition feeding": [ { "intervention_type": "OTHER" } ] }

NCT05765773

An Open Comparative Study of the Effectiveness and Incomparable Study of the Immunogenicity and Safety of the Vaccine (CoviVac) for Adults Aged 60 Years and Older

https://clinicaltrials.gov/study/NCT05765773

ACTIVE_NOT_RECRUITING

An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac) Produced by FSBSI Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products for Adults Aged 60 Years and Older

NO

Corona Virus Infection|Vaccine|COVID-19

BIOLOGICAL: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI Chumakov FSC R&D IBP RAS

Frequency of development, type and association with vaccination of adverse events during the study., Frequency of development, type and association with vaccination of adverse events during the study., 6 month|Titer of specific antibodies, The proportion of volunteers from the total number of vaccinated with the level of seroconversion (titer of specific antibodies = 4 times the baseline level) on 21 days after the course of vaccination in the reaction of viral neutralization and / or ELISA., 21 days|GMT on day 21 after the course of vaccination, The proportion of volunteers with an increase in the level of immune response in the form of geometric mean titers of specific antibodies (GMT) on day 21 after the course of vaccination in the reaction of viral neutralization and / or ELISA., 21 days|The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters., The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters., 6 month

ARVI, COVID-19, Frequency, severity and duration of incidence of Acute respiratory diseases (ARVI, COVID-19) within six months after triple vaccination., 6 month

Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER_GOV

INTERVENTIONAL

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

№ VKI-P-II-07/21

2021-07-01

2022-10-01

2023-03-01

2023-03-13

2023-03-13

State Budgetary Healthcare Institution of the Moscow region Elektrostal Central City Hospital , Elektrostal, Moscow Oblast, 144000, Russian Federation|Federal State Budgetary Scientific Institution I.I. Mechnikov Scientific Research Institute of Vaccines and Serums , Moscow, 105064, Russian Federation|FSBSI Chumakov FSC R&D IBP RAS, Moscow, 108819, Russian Federation|Private healthcare institution Clinical Hospital Russian Railways-Medicine named after N.A. Semashko , Moscow, 109386, Russian Federation|Limited Liability Company Scientific Research Center Ecosecurity , Moscow, 196143, Russian Federation|Federal State Budgetary Healthcare Institution Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency , Novosibirsk, 630559, Russian Federation|Federal State Budgetary Educational Institution of Higher Education Perm State Medical University named after Academician E.A. Wagner of the Ministry of Health of the Russian Federation, Perm, 614990, Russian Federation

{ "CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI Chumakov FSC R&D IBP RAS": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT03371173

ORal IrON Supplementation With Ferric Maltol in Patients With Pulmonary Hypertension (ORION-PH-1)

https://clinicaltrials.gov/study/NCT03371173

ORION-PH-1

TERMINATED

This is an explorative, open-label, uncontrolled, single center study to explore the preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency anemia.

NO

Hypertension, Pulmonary|Anemia, Iron Deficiency

DRUG: Ferric maltol 30 mg (Feraccru®)

Change in hemoglobin level from baseline to week 12, measurement of hemoglobin in blood, baseline to week 12

Change in hemoglobin from baseline to week 6, measurement of hemoglobin in blood, baseline to week 6|Change in serum ferritin levels from baseline to week 6 and 12, measurement of serum ferritin levels, baseline to week 6 and baseline to week 12|Change in transferrin saturation from baseline to week 6 and 12, measurement of transferrin saturation, baseline to week 6 and baseline to week 12|Change in 6 min walking distance from baseline to week 12, measurement of functional exercise capacity, baseline to week 12|Change in serum NT-proBNP from baseline to weeks 6 and 12, measurement of serum NT-proBNP, baseline to week 6 and baseline to week 12|Change in echocardiographic markers of right ventricular function from baseline to week 12 (1), measurement of right atrial area, from baseline to week 12|Change in echocardiographic markers of right ventricular function from baseline to week 12 (2), measurement of right ventricular diameter, from baseline to week 12|Change in echocardiographic markers of right ventricular function from baseline to week 12 (3), measurement of fractional area change, from baseline to week 12|Change in echocardiographic markers of right ventricular function from baseline to week 12 (4), measurement of tricuspid annular plane systolic excursion, from baseline to week 12|Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12, measurement of different parameter according to an evaluated process, from baseline to week 6 and week 12

Incidence of Adverse Events [Safety and Tolerability], Number of Adverse Events, first application of IMP until 4 weeks after treatment discontinuation|Incidence of Serious Adverse Events [Safety and Tolerability], Number of Serious Adverse Events, first application of IMP until 4 weeks after treatment discontinuation

Hannover Medical School

Shields, Shields and Associates

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

ORION-PH-1

2018-03-27

2020-03-19

2020-03-19

2017-12-13

2020-04-21

Hannover Medical School, Hannover, 30625, Germany

{ "Ferric maltol": [ { "intervention_type": "DRUG", "description": "Ferric maltol 30 mg (Feraccru\u00ae)", "name": "Ferric maltol", "synonyms": [ "Ferric maltol", "Accrufer", "Feraccru" ], "drugbank_id": "DB15598", "generic_names": [ "Ferric maltol" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Ferric%20maltol" } ] }

NCT04742673

Maximizing trEatment of Neurological Dysfunction Using INtravenous Guanfacine Study

https://clinicaltrials.gov/study/NCT04742673

MENDING

ACTIVE_NOT_RECRUITING

This proof-of-concept study examines whether the acute brain dysfunction that occurs in critically ill patients is improved by administration of intravenous guanfacine.

NO

Critical Illness|Delirium|Cognitive Impairment

DRUG: Guanfacine|DRUG: Placebo

Number of days alive without delirium or coma, 14 days

Days alive and free of mechanical ventilation, 28 days|Days alive and free of the intensive care unit, 28 days|Cognitive function, Telephone Montreal Cognitive Assessment, up to 180 days after hospital discharge

Days alive and free of the hospital, 28 days|Mortality, up to 1 year|Physical Function, Patient-Reported Outcomes Measurement Information System V.1.2-Physical Function 8b, up to 180 days after hospital discharge|Global Health, Patient-Reported Outcomes Measurement Information System V.1.1-Global, up to 180 days after hospital discharge|Pain Interference, Patient-Reported Outcomes Measurement Information System V.1.0-Pain Interference 8a, up to 180 days after hospital discharge|Applied Cognition, Patient-Reported Outcomes Measurement Information System V.1.0-Applied Cognition, up to 180 days after hospital discharge|Sleep, Patient-Reported Outcomes Measurement Information System V.1.0-Sleep Disturbance, up to 180 days after hospital discharge|Co-administration of sedatives, analgesics, and antipsychotics, Frequency and quantity of administration, up to 14 days|Hypotension, Refractory systolic blood pressure < 90 mm Hg or Mean arterial blood pressure < 65 mm Hg despite ongoing ICU therapies, up to 14 days|Bradycardia, Heart rate < 60 beats per minute despite ongoing ICU therapies, up to 14 days|Mental status, New, acute neurologic disturbances such as blurred vision, dizziness, weakness, or vertigo, up to 14 days

Vanderbilt University Medical Center

Massachusetts General Hospital|National Institute on Aging (NIA)

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

U11543|3R01AG053582-05S1

2021-05-04

2024-03-30

2025-12-31

2021-02-08

2024-04-23

Vanderbilt University Medical Center, Nashville, Tennessee, 37212, United States

{ "Guanfacine": [ { "intervention_type": "DRUG", "description": "Guanfacine", "name": "Guanfacine", "synonyms": [ "Estulic", "BS100141", "Guanfacine Monohydrochloride", "Guanfacina", "Guanfacinum", "Hydrochloride, Guanfacine", "Guanfacine Hydrochloride", "Lon798", "Guanfacine", "Tenex", "BS 100 141", "Intuniv", "Monohydrochloride, Guanfacine", "BS-100-141" ], "medline_plus_id": "a601059", "generic_names": [ "Guanfacine" ], "mesh_id": "D058647", "drugbank_id": "DB01018" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04551573

A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects

https://clinicaltrials.gov/study/NCT04551573

WITHDRAWN

This is a single-center, open-label, fixed sequence, pharmacokinetic interaction study between bictegravir and tenofovir alafenamide with rifapentine dosed either daily or weekly. Primary Aims * To assess the effect of once-weekly rifapentine on the steady-state PK of BIC * To assess the effect of once-daily rifapentine on the steady-state PK of BIC Secondary Aims * To assess the effect of daily dosed rifapentine on steady-state PK of TAF (measured as plasma and IC concentrations of TFV-DP) * To assess the effect and timing of interactions of weekly dosed rifapentine on steady-state PK of TAF (measured as plasma and IC concentrations of TFV-DP) * To assess the safety of BIC/TAF/FTC when coadministered with once-weekly or once-daily rifapentine

NO

Tuberculosis|Hiv

DRUG: Rifapentine daily|DRUG: Rifapentine weekly

Plasma area under the curve (AUC) of Bictegravir between groups, Determining plasma AUCtau of Bictegravir when co-administered with rifapentine as once-daily or once-weekly, 8 weeks|Maximum plasma concentrations(Cmax) of Bictegravir between groups, Determining Cmax of Bictegravir when co-administered with rifapentine as once-daily or once-weekly, 8 weeks|Concentrations at the end of dosing interval (Ctau) of Bictegravir between groups, Determining Ctau of Bictegravir when co-administered with rifapentine as once-daily or once-weekly, 8 weeks|Time to total maximum plasma concentrations (Tmax) of Bictegravir between groups, Determining Tmax of Bictegravir when co-administered with rifapentine as once-daily or once-weekly, 8 weeks

Plasma area under the curve (AUC) of tenofovir alafenamide (TAF) between groups, Determining plasma AUCtau of TAF when co-administered with rifapentine as once-daily or once-weekly, 8 weeks|Maximum plasma concentrations(Cmax) of TAF between groups, Determining Cmax of TAF when co-administered with rifapentine as once-daily or once-weekly, 8 weeks|Steady-state Intracellular (IC) concentration changes of tenofovir-diphosphate (TFV-DP), Determining steady-state intracellular (IC) concentration changes of TFV-DP when co-administered with rifapentine at two different dosing intervals (daily and weekly), 8 weeks|Adverse Events of medications, Adverse events of co-administration of rifapentine with BIC/TAF/ Emtrictabine (FTC), 8 weeks

Yale University

Gilead Sciences

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

2000027436

2021-05

2021-10

2021-11

2020-09-16

2021-09-20

Yale New Haven Hospital, New Haven, Connecticut, 06520, United States

{ "Rifapentine": [ { "intervention_type": "DRUG", "description": "Rifapentine daily", "name": "Rifapentine", "synonyms": [ "Priftin", "3-(((4-Cyclopentyl-1-piperazinyl)imino)methyl)rifamycin", "Cyclopentylrifampicin", "Rifapentin", "Rifapentine" ], "medline_plus_id": "a616011", "generic_names": [ "Rifapentine" ], "drugbank_id": "DB01201", "wikipedia_url": "https://en.wikipedia.org/wiki/Rifapentine" }, { "intervention_type": "DRUG", "description": "Rifapentine weekly", "name": "Rifapentine", "synonyms": [ "Priftin", "3-(((4-Cyclopentyl-1-piperazinyl)imino)methyl)rifamycin", "Cyclopentylrifampicin", "Rifapentin", "Rifapentine" ], "medline_plus_id": "a616011", "generic_names": [ "Rifapentine" ], "drugbank_id": "DB01201", "wikipedia_url": "https://en.wikipedia.org/wiki/Rifapentine" } ] }

NCT05624073

Blind Tracheal Intubation Through Supraglottic Airway Devices

https://clinicaltrials.gov/study/NCT05624073

RECRUITING

Tracheal intubation is considered the gold standard for protecting the airway. As the supraglottic airway devices (SADs) could be inserted without laryngoscopy, so that SADs with different designs and safety issues could be used to manage difficult airways in anesthesia and emergency medicine with continuous patient oxygenation &ventilation, less hemodynamic stress response and less postoperative complications. These advantages encourage the use of a proper SAD as a conduit for endotracheal intubation in stressful conditions. This study will be carried out to compare the Air-QTM Blocker and LarysealTM Pro for blind tracheal intubation during elective ophthalmic surgeries under general anesthesia. Intubation through SAD can be performed using a fiber-optic bronchoscope or blindly. Blind intubation is meaning that the tube is inserted through SAD without direct visualization of the airway. Success rate of blind intubation ranges between 15% and 97%, mostly depending on the type of used SAD, patient characteristics and operator skills. The availability of blind intubation through SAD is important in cases of difficult intubation (either anticipated or unanticipated) especially if fiber-optic is not available, so that SAD will be convenient for untrained personnel.

NO

Respiration and the Airways With Laryngeal Masks

DEVICE: Air-QTM Blocker|DEVICE: LarySealTM Pro

Total insertion time (seconds), Total insertion time (seconds): insertion time (seconds) of the SAD is the time needed for correct SAD placement &started when SAD touched teeth to the first recorded rectangular capnogram curve with satisfactory bilateral chest expansion + insertion time of the endotracheal tube through the SAD (seconds) is the time in seconds from insertion of the endotracheal tube blindly until capnographic confirmation., 200 seconds

Cairo University

ALL

ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

EH-2022

2022-12-17

2023-11-01

2023-12-01

2022-11-21

2023-02-14

Department of Anesthesia, Surgical ICU, and Pain Management, Cairo, 11562, Egypt|Reham Ali Abdelhaleem Abdelrahman, Cairo, 11562, Egypt

{ "Air-QTM Blocker": [ { "intervention_type": "DEVICE" } ], "LarySealTM Pro": [ { "intervention_type": "DEVICE" } ] }

NCT00434473

IMPACTS Trial: Investigation of the Modulation of Phospholipase in Acute Chest Syndrome

https://clinicaltrials.gov/study/NCT00434473

COMPLETED

The study will be conducted at 15-20 US centers in a randomized, placebo-controlled, double-blind fashion. Enrollees will be hospitalized sickle cell disease (SCD) patients at-risk for acute chest syndrome (ACS) based on the presence of vaso-occlusive crisis (VOC), fever (T ≥38.0°C) and serum sPLA2 concentration ≥50 ng/mL.

NO

Sickle Cell Disease|Vaso-occlusive Crisis|Acute Chest Syndrome

DRUG: A-001|OTHER: Placebo

To determine the safety and tolerability of different doses of A 001 therapy when administered as a 2-day continuous infusion to sickle cell disease (SCD) patients at-risk for the acute chest syndrome (ACS)., Study end

To determine the pharmacokinetic profile of A-001 in SCD patients, Study end|To confirm the ability of A-001 infusion to suppress serum sPLA2 activity in SCD patients with elevated serum sPLA2, Study end|To determine the efficacy of A-001 infusion in preventing ACS in SCD patients with the combination of vaso-occlusive crisis (VOC), fever, and elevated serum sPLA2, Study end

Anthera Pharmaceuticals

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

AN-SCD1121

2006-12

2009-08

2009-12

2007-02-13

2014-03-04

Howard University Hospital, Washington, District of Columbia, 20060, United States|Children s Healthcare of Atlanta, Atlanta, Georgia, 30342, United States|Children s Memorial Hospital, Chicago, Illinois, 60614, United States|SUNY Downstate Medical Center, Brooklyn, New York, 11203, United States|Duke University Comprehensive Sickle Cell Center, Durham, North Carolina, 27713, United States|Virginia Commonwealth University, Richmond, Virginia, 23219, United States

{ "A-001": [ { "intervention_type": "DRUG" } ], "Placebo": [ { "intervention_type": "OTHER" } ] }

NCT03754673

Role of MRI in Diagnosis of Pulmonary Embolism

https://clinicaltrials.gov/study/NCT03754673

COMPLETED

The aim of this work is to emphasize the role of non-contrast MR imaging in diagnosis of acute pulmonary embolism in comparison to CTA and contrast enhanced MRA as gold standard techniques.

NO

Pulmonary Embolism

DEVICE: MRI

detection of pulmonary embolism by MRI without contrast administration, diagnosis and detection of pulmonary embolism by MRI in comparison with MSCT pulmonary angiography, baseline

Assiut University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Plumonary MRI

2018-12-01

2020-01-01

2020-04-30

2018-11-27

2020-05-27

Hossam Mohammed Mostafa, Assiut, 020, Egypt

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

NCT05682573

Study on Immune Status of Patients With COVID-19

https://clinicaltrials.gov/study/NCT05682573

RECRUITING

This study is a prospective cohort study aimed to clarify the continuous immune state changes of patients with COVID-19. Investigators include the patients admitted to the hospital within one week after the onset of COVID-19. 10ml of patients blood was collected day 1, day 7, day 14 , and day 20 after the patients admitted to the hospital. The blood inflammatory factors, immune related molecules, and immune cells were detected to determine the changes of patients immune status. The impact of immune status changes on prognosis and quality of life in later follow-up period was evaluated by various questionnaires and evaluation scales.

NO

COVID-19|Immunity|Life Quality

DIAGNOSTIC_TEST: hospitalized patient

Changes in the concentration of inflammatory markers (IL-1β、IL-2、 IL-2R 、IL-4 、 IL-6 、 IL-8、 IL-10 、 interferon-gamma（IFN-γ）、tumour necrosis factor alpha(TNF-α) 、vascular endothelial growth factor（VEGF）, etc.) in peripheral blood., 1, 7, 14, 20 days after the patient arrives at the hospital|Changes in the concentration of immunosuppression makers(HLA-DR, Programmed Cell Death Ligand 1 （PD-1）, T cell immunoglobulin and mucin domain 3（TIM-3）,etc.) in peripheral blood., 1, 7, 14, 20 days after the patient arrives at the hospital|Changes in the number of immune cells(Th1/Th2 cell, Treg cell, Myeloid-derived suppressor cells,etc.) in peripheral blood., 1, 7, 14, 20 days after the patient arrives at the hospital

self-reported symptom, 2，6 months after the patient arrives at the hospital|health related quality of life (HRQoL) questionnaire,, There are five dimensions, each with a minimum value of 1 and a maximum value of 3, and the higher score mean a worse outcome, 2，6 months after the patient arrives at the hospital|Hospital Anxiety and Depression Scale (HADS), There are two dimensions, each with a minimum value of 0 and a maximum value of 21，and higher score mean a worse outcome, 2，6 months after the patient arrives at the hospital

Qilu Hospital of Shandong University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Qilu-20230105-pang

2023-01-05

2023-11-30

2023-12-31

2023-01-12

2023-01-12

Qilu Hospital of Shandong University, Jinan, Shandong, 250112, China

{ "hospitalized patient": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT05569473

Evaluation of Volume Stable Collagen Matrix in the Regenerative Outcome of Periodontal Intrabony Defects

https://clinicaltrials.gov/study/NCT05569473

NOT_YET_RECRUITING

Periodontal intrabony defect is a specific osseous defect with definite morphology. Numerous therapeutic modalities for restoring such defects have been investigated. Nanocomposites and nanostructured materials are thought to have a key function in hard tissue research, since natural bone tissue is a distinctive model of a nanocomposite. Collagen has been potentially used in periodontal tissue engineering. The integration of collagen as a structural protein, serving as an essential component of connective tissue into three-dimensional scaffolds implanted after periodontal injury, necrosis or inflammation has attracted much attention in tissue regeneration. If a collagen matrix collapses after implantation, host cell migration and blood vessel penetration may be impaired, which in turn negatively influences tissue degradation and integration as well as extracellular matrix production in the interior of the biomaterial. Thus, volume stability is an important parameter for tissue augmentation. Volume stable collagen matrix (VCMX) is able to overcome the volume stability limitation of most commercially available grafts.7 It is one of the most biocompatible, novel material to be used in this study. It will be the first time that VCMX is to be used to regenerate the periodontal tissues in intrabony defects in humans.

NO

Intrabony Periodontal Defect

PROCEDURE: TEST GROUP: VCMX + OFD, CONTROL GROUP : OFD ONLY

Probing depth (PD), probing depth will be measured as the distance from the gingival margin to the base of pocket the probing depth. Measurements will be assessed using a calibrated manual periodontal probe (PCP UNC-15 Hu friedy Chicago, IL, USA. The probe will be inserted in the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of a tooth mesio buccal, mid buccal, distobuccal, mesio lingual, mid lingual and distolingual measurements will be rounded to the nearest whole mm., 9 MONTHS|Clinical attachment level (CAL), clinical attachment level will be measured at the distance between the base of the pocket and the cement enamel junction (CEJ). Measurements will be made at 6 sites of each tooth - mesiobuccal, mid buccal, disto buccal, mesio lingual, mid lingual and distolingual using UNC 15 probe., 9 MONTHS|BONE FILL PERCENTAGE(BF%), bone fill percentage will be recorded pre op and post op., 9 MONTHS

Postgraduate Institute of Dental Sciences Rohtak

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

Pratiksha PGIDS/BHRC/22/30

2022-10-01

2024-06-30

2024-06-30

2022-10-06

2022-10-06

Post Graduate Institute of Dental Science, Rohtak, Haryana, 124001, India

{ "TEST GROUP: VCMX + OFD, CONTROL GROUP : OFD ONLY": [ { "intervention_type": "PROCEDURE" } ] }

NCT05318573

A Study to Evaluate Safety, Efficacy of FF-10832 in Combination With Pembrolizumab in Solid Tumors

https://clinicaltrials.gov/study/NCT05318573

RECRUITING

To confirm a recommended Phase 2 dose (RP2D) of FF-10832 (Gemcitabine Liposome Injection) given intravenously Day 1 of a 21-day cycle, in combination with 200 mg pembrolizumab given intravenously Day 1 of the same 21-day cycle, for treatment of advanced solid tumors.

NO

Advanced Solid Tumor

DRUG: Pembrolizumab|DRUG: FF-10832

Determine the incidence of Treament Emergent Adverse Events (TEAE), Safety and tolerability assessed by adverse events (AEs) and serious adverse events (SAEs) and to confirm dose (RP2D) of FF-10832 given intravenously Day 1 of a 21 day cycle, in combination with 200 mg pembrolizumab, given intravenously Day 1 of the same 21-day cycle, for treatment of advanced solid tumors., 7 years|Duration of Stable Disease in Monotherapy, To obtain a preliminary estimate of efficacy of FF-10832 monotherapy in expansion cohorts of patients with urothelial cancer (UC) and non-small cell lung cancer (NSCLC). Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression are met, 7 years|Duration of Stable Disease in Combination Therapy, To obtain a preliminary estimate of efficacy of the combination in expansion cohorts of patients with UC and NSCLC. Duration of Stable Disease is the length of time from the start of the treatment until the criteria for progression, 7 years

Determine Safety Profile of Monotherapy, To describe the safety profile of FF-10832 monotherapy 40 mg/m2 given intravenously Day 1 of a 21-day cycle, including treatment-emergent AEs. Safety assessed by adverse events (AEs) and serious adverse events (SAEs), 7 years|Determine Safety Profile of Combination Therapy, Describe the safety profile of the combination, including dose limiting toxicities, immune related toxicities, and other treatment emergent AEs. Safety assessed by adverse events (AEs) and serious adverse events (SAEs), 7 years|Overall Response Rate (ORR), Overall Response Rate is determined by classification of solid tumors via RECIST v.1.1, 7 years|Duration of Response (DOR), Duration of Response is calculated from the date of first response to the date of progression or death, 7 years|Progression-free survival (PFS), Progression-free survival will be calculated from the date of first treatment to the date of progression or death, 7 years|Overall survival (OS), Overall survival will be calculated from the date of first treatment to the date of death from any cause, 7 years

Fujifilm Pharmaceuticals U.S.A., Inc.

Merck Sharp & Dohme LLC

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

FF10832-PEM-201/KEYNOTE-B57|MK-3475-B57

2022-06-01

2029-05

2029-11

2022-04-08

2024-06-26

Sharp Memorial Hospital (Oncology Clinical Research), San Diego, California, 92123, United States|Sibley Memorial Hospital, Washington, District of Columbia, 20016, United States|University of Kansas Cancer Center - Westwood, Westwood, Kansas, 66205, United States|University of Kentucky Medical Center, Lexington, Kentucky, 40536, United States|University of Louisville Brown Cancer Center, Louisville, Kentucky, 40202, United States|Henry Ford Cancer - Detroit (Brigitte Harris Cancer Pavilion), Detroit, Michigan, 48202, United States|Washington University School of Medicine, Center for Adv Medicine, Saint Louis, Missouri, 63110, United States|Comprehensive Cancer Centers of Nevada - Southern Hills, Las Vegas, Nevada, 89148, United States|Atlantic Health System / Morristown Medical Center, Morristown, New Jersey, 07960, United States|NYU Langone Health, New York, New York, 10016, United States|Icahn School of Medicine at Mount Sinai, New York, New York, 10029, United States|TriHealth Cancer Institute; Good Samaritan Hospital, Cincinnati, Ohio, 45220, United States|Providence Cancer Institute Franz Clinic, Portland, Oregon, 97213, United States|Hospital of the Univ of Pennsylvania Perlman Center, Philadelphia, Pennsylvania, 19104, United States|UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, 15232, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Avera Cancer Institute, Sioux Falls, South Dakota, 57105, United States|Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States|University of Texas Southwestern Medical Center, Dallas, Texas, 75235, United States|Virginia Cancer Specialists, PC, Fairfax, Virginia, 22031, United States|University of Wisconsin Clinical Science Center, Madison, Wisconsin, 53792, United States

{ "Pembrolizumab": [ { "intervention_type": "DRUG", "description": "Pembrolizumab", "name": "Pembrolizumab", "synonyms": [ "Keytruda", "Lambrolizumab", "Pembrolizumab" ], "medline_plus_id": "a614048", "generic_names": [ "Pembrolizumab" ], "drugbank_id": "DB09037", "wikipedia_url": "https://en.wikipedia.org/wiki/Pembrolizumab" } ], "FF-10832": [ { "intervention_type": "DRUG" } ] }

NCT06053073

Induction to Labour With Double Cervical Ballon at Home Versus at Hospital

https://clinicaltrials.gov/study/NCT06053073

INDOBAMHOS

RECRUITING

The goal of this clinical trial] is to compare the outcomes between induction to labour at home versus hospitalized. The main questions it aims to answer are: * Can the induction to labour at home with cervical rippening ballon increase the vaginal delivery rate? * Will the induction to labour at home increase maternal satisfaction * Will the induction to labour at home improve medical circuits and coulb it be cost effective? Participants who meet inclusion criteria will undergo randomization so as to be asignated an induction to labour at home or in the hospital. Researchers will compare both labour induction groups to see if the induction to labour at home has better outcomes as described previously.

NO

Induced; Birth|Cervical Dilatation|Live Birth

DEVICE: Cervical rippening at home|DEVICE: Cervical rippening in the hospital

Type of delivery, Vaginal birth, Cesarean section, End of the delivery

Parity, Number of pregnancies and deliveries of each patient, At time of recruitment and end of delivery, about 1 or 2 days|Indication of induction, Cathegorical variable, it will be studied the different reason that motivated the induction to delivery for each patient, 1 day|Weeks of gestation, Measured in number of weeks and days, Only at time of recruitment, 1 day|Bishop score, Score obtained when evaluating the different features of the uterine cervix by touch, Before inserting the rippening balloon and after removing it, about 6 hours|Time of dilatation, Hours, During labour and until delivery, between 1 and 3 days|Time of cervical rippening balloon, Hours, At the insertion of the rippening balloon and after removing it, about 6 hours|Partian emptying of the balloon due to pain, Milliliters, During cervical rippening, about 6 hours|Pharmacological analgesia during the cervical rippening, Number of drugs administered, During cervical rippening, about 6 hours|Adverse outcomes, Number of adverse outcomes, During cervical rippening and labor, between 6 hours and 3 days|Artificial Amniorrhexis, Presence or absence, During cervical rippening and labor, between 6 hours and 3 days|Oxytocin infusion, Presence or absence, During cervical rippening and labor, between 6 hours and 3 days|Subsequent PGE2 use, Presence or absence, During cervical rippening and labor, between 6 hours and 3 days|Hyperstimulation, Presence or absence, During cervical rippening and labor, between 6 hours and 3 days|Type of delivery, Cathegorical variable, it will be studied the different type of delivery for each patient, At the moment of the delivery, between 1 day and 3|Time to delivery, Hours, At the moment of the delivery, between 1 day and 3|Reason for instrumentation, Cathegorical variable, it will be studied the different reason of instrumentation, At the moment of the delivery, between 1 day and 3|Reason for Cesarean section, Cathegorical variable, it will be studied the different reason of cesarean section, At the moment of the delivery, between 1 day and 3|Epidural anesthesia, Presence of absence, During cervical rippening and labor, between 6 hours and 3 days|Days of postpartum hospitalization, Days, From the delivery to discharge from hospital, between 1 and 7 days|Fever during childbirth, Presence of absence, At the moment of the delivery, between 1 day and 3|Perineal injuries, Presence of absence, At the moment of the delivery, between 1 day and 3|Postpartum haemorrage, Presence of absence, At the moment of the delivery, between 1 day and 3|Anemia, Presence of absence, At the moment of the delivery, between 1 day and 3|Uterine rupture, Presence of absence, At the moment of the delivery, between 1 day and 3|Maternal ICU admission, Presence of absence, At the moment of the delivery, between 1 day and 3|Sepsis, Presence of absence, At the moment of the delivery, between 1 day and 3|Meconial amniotic fluid, Presence of absence, During cervical rippening and labor, between 6 hours and 3 days|Arterial pH, pH value of neonatal umbilical artery, At the moment of the delivery, between 1 day and 3|Venous pH, pH value of neonatal umbilical vein, At the moment of the delivery, between 1 day and 3|APGAR score, Score obtained when evaluating neonatal apearance, heart rate, muscular tone, activity, breath, gestures, At the moment of the delivery, between 1 day and 3|Neonatal Intensive Care Unit (NICU) admission, Days, From the delivery to discharge from hospital, between 1 and 7 days|Neonatal antibiotic administracion, Presence of absence, From the delivery to discharge from hospital, between 1 and 7 days|Neonatal death, Presence of absence, From the delivery to discharge from hospital, between 1 and 7 days|Hypoxic-ischemic encephalopathy, Presence of absence, From the delivery to discharge from hospital, between 1 and 7 days|Neonatal seizures, Presence of absence, From the delivery to discharge from hospital, between 1 and 7 days|Neonatal intubation or chest compressions, Presence of absence, From the delivery to discharge from hospital, between 1 and 7 days|Persistent pulmonary hypertension of the newborn, Presence of absence, From the delivery to discharge from hospital, between 1 and 7 days|Pain/Discomfort, Measure with analogue scale from 1 to 10, During insertion of the cervical balloon, between 1 and 3 minutes|Pain/Discomfort, Measure with analogue scale from 1 to 10, During cervical rippening, about 6 hours|Labor Agentry Scale, Score obtained adding different items on the Scale, Up to two months|Edinburg questionnaire for postpartum depression, Score obtained adding different items on the Scale, Up to two months|Impact of Event Scale-Revised, Score obtained adding different items on the Scale, Up to two months|Breastfeeding, Presence of abscence, Up to two months|SF-12 questionnaire, Score obtained adding different items on the Scale, Up to two months|Diagnosis of depression, Presence or Absence, Up to two months|Medical costs, Measured in euros, One year

Maternal age, Years, At time of recruitment and end of delivery, about 1 or 2 days|Ethnicity, Cathegorical variable, it will be studied the different ethnicities of the patients, At time of recruitment and end of delivery, about 1 or 2 days|Language spoken at home, Cathegorical variable, it will be studied the different ethnicities of the patients, At time of recruitment and end of delivery, about 1 or 2 days|Socioeconomic data, Number of people in the home, type of dwelling, socio-professional category, level of education, At time of recruitment and end of delivery, about 1 or 2 days|Height and weight, Measured in centimeters and kilograms, combined in Body Mass Index, At time of recruitment and end of delivery, about 1 or 2 days

Fundació Institut de Recerca de l Hospital de la Santa Creu i Sant Pau

FEMALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

IIBSP-DBC-2021-35

2023-03-27

2025-03

2026-03

2023-09-25

2023-09-25

Hospital de la Santa Creu i Sant Pau, Barcelona, 08025, Spain

{ "Cervical rippening at home": [ { "intervention_type": "DEVICE" } ], "Cervical rippening in the hospital": [ { "intervention_type": "DEVICE" } ] }

NCT04087473

Plasma Molecular Profiling in ALK Inhibitor Resistant NSCLC

https://clinicaltrials.gov/study/NCT04087473

RECRUITING

The investigators plan to understand a comprehensive molecular profiling via the plasma, with the primary aim of using this form on analysis to guide subsequent treatment selection. This study will provide a better understanding of ALK resistance in the treatment of Asian lung cancers and allow for improved clinical outcomes by matching the secondary mutations to an ALK inhibitor which would allow for the greatest coverage ultimately leading to lasting duration of response.

NO

Non-small Cell Lung Cancer|ALK-Positive Lung Cancer

Molecular profiling of plasma, Profiling of the collected plasma samples at a molecular level to evaluate the molecular epidemiology of ALK fusion oncogene positive lung cancer, 2 to 4 weeks after collection of plasma

Patient survival status, After molecular profiling has been completed, every few months up to 2 years|Subsequent patient treatment status, After molecular profiling has been completed, every few months up to 2 years|Clinical outcomes of the subsequent treatments the patients receive, After molecular profiling has been completed, every few months up to 2 years

National Cancer Centre, Singapore

Guardant Health AMEA, Inc.

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

ATORG004

2019-08-23

2024-12-31

2025-12-31

2019-09-12

2024-02-01

The Chinese University of Hong Kong, Hong Kong, Hong Kong|Asan Medical Centre, Seoul, 05505, Korea, Republic of|Seoul National University Hospital, Seoul, Korea, Republic of|University Malaya Medical Centre, Kuala Lumpur, Malaysia|National Cancer Center Singapore, Singapore, 169690, Singapore

{}

NCT05364073

Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

https://clinicaltrials.gov/study/NCT05364073

RECRUITING

This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

NO

Non-Small Cell Lung Cancer (NSCLC)|Metastatic Non-Small Cell Lung Cancer|Advanced Non-Small Cell Lung Cancer|HER2 Exon 20 Mutations|EGFR Exon 20 Mutations|EGFR Uncommon Mutations, Including G719X and S768I

DRUG: Furmonertinib|DRUG: Furmonertinib|DRUG: Furmonertinib|DRUG: Furmonertinib|DRUG: Furmonertinib

Stage 1: Number of incidence and severity of adverse events (AEs) as a measure of safety and tolerability of Furmonertinib, Up to 36 months after first dose|Stage 2: Overall Response Rate (ORR), Up to 36 months after first dose

Stage 1: Overall Response Rate, Up to 36 months after first dose|Stage 1: Duration of Response (DOR), Up to 36 months after first dose|Stage 1: Disease Control Rate, Up to 36 months after first dose|Stage 1: Progression Free Survival, Up to 36 months after first dose|Stage 1: Depth of Response, Up to 36 months after first dose|Stage 1: Overall survival, Up to 36 months after first dose|Stage 1: Central Nervous System ORR, Up to 36 months after first dose|Stage 1: Central Nervous System DOR, Up to 36 months after first dose|Stage 1: Plasma concentrations of furmonertinib and its major metabolite (AST5902), Up to 36 months after first dose|Stage 1, Cohort 1, Backfill only: Plasma concentrations of furmonertinib and its major metabolite (AST5902), Up to 36 months after first dose|Stage 1, Cohort 1, Backfill only: Plasma concentrations of midazolam and its metabolite (1-OH-midazolam), Up to 36 months after first dose|Stage 2, all cohorts: Duration of Response, Up to 36 months after first dose|Stage 2, all cohorts: Disease Control Rate, Up to 36 months after first dose|Stage 2, all cohorts: Progression Free Survival, Up to 36 months after first dose|Stage 2, all cohorts: Depth of Response, Up to 36 months after first dose|Stage 2, all cohorts: Overall survival, Up to 36 months after first dose|Stage 2, all cohorts: Central Nervous System ORR, Up to 36 months after first dose|Stage 2, all cohorts: Central Nervous System DOR, Up to 36 months after first dose|Stage 2, Cohort 4 only: Overall Response Rate, Up to 36 months after first dose|Stage 2, all cohorts: Number of incidence and severity of AEs as a measure of safety and tolerability of Furmonertinib, Up to 36 months after first dose|Stage 2, all cohorts: Plasma concentrations of furmonertinib and its major metabolite (AST5902), Up to 36 months after first dose

ArriVent BioPharma, Inc.

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

FURMO-002

2022-06-30

2025-09

2025-09

2022-05-06

2024-06-21

ArriVent Investigative Site, Prescott, Arizona, 86301, United States|ArriVent Investigative Site, Sacramento, California, 95817, United States|ArriVent Investigative Site, Celebration, Florida, 34747, United States|ArriVent Investigative Site, Detroit, Michigan, 48202, United States|ArriVent Investigative Site, Houston, Texas, 77030, United States|ArriVent Investigative Site, Fairfax, Virginia, 22031, United States|ArriVent Investigative Site, Blacktown, New South Wales, 2148, Australia|ArriVent Investigative Site, St Leonards, New South Wales, 2065, Australia|ArriVent Investigative Site, Heidelberg, Victoria, 3084, Australia|Arrivent Investigative Site, Edmonton, T6G 1Z2, Canada|Arrivent Investigative Site, Toronto, M5G 2M9, Canada|Allist Investigative Site, Hefei, Anhui, 230001, China|Allist Investigative Site, Beijing, Beijing, 101119, China|Allist Investigative Site, Chaoyang, Beijing, 100021, China|Allist Investigative Site, Chongqing, Chongqing, 400030, China|Allist Investigative Site, Guiyang, Guizhou, 550004, China|Allist Investigative Site, Harbin, Heilongjiang, 150081, China|Allist Investigative Site, Zhengzhou, Henan, 450003, China|Allist Investigative Site, Zhengzhou, Henan, 450052, China|Allist Investigative Site, Wuhan, Hubei, 430022, China|Allist Investigative Site, XuZhou, Jiangsu, 221000, China|Allist Investigative Site, Nanchang, Jianxi, 330008, China|Allist Investigative Site, Changchun, Jilin, 130012, China|Allist Investigative Site, Jinan, Shan Dong, 250021, China|Allist Investigative Site, Jinan, Shandong, 250117, China|Allist Investigative Site, Shanghai, Shanghai, 200030, China|Allist Investigative Site, Taiyuan, Shanxi, 030013, China|ArriVent Investigative Site, Lyon, 69373, France|Arrivent Investigative Site, Toulouse, 31059, France|Arrivent Investigative Site, Villejuif, 94800, France|ArriVent Investigative Site, Medolla, 47014, Italy|ArriVent Investigative Site, Chiba-Shi, Chiba, 260-0013, Japan|Arrivent Investigative Site, Ōsaka-sayama, Osaka, 589-8511, Japan|Arrivent Investigative Site, Chuo, Tokyo, 104-0045, Japan|Arrivent Investigative Site, Koto-Ku, Tokyo, 135-8550, Japan|Arrivent Investigative Site, Gwangju, 61469, Korea, Republic of|Arrivent Investigative Site, Seoul, 2447, Korea, Republic of|Arrivent Investigative Site, Amsterdam, Noord-Holland, 1066 CX, Netherlands|ArriVent Investigative Site, Barcelona, 08035, Spain|ArriVent Investigative Site, Madrid, 28033, Spain|ArriVent Investigative Site, Madrid, 28050, Spain|ArriVent Investigative Site, Valencia, 46026, Spain|ArriVent Investigative Site, London, NW12PG, United Kingdom

{ "Furmonertinib": [ { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" } ] }

NCT05013073

ASTHMAXcel Emergency Department Study

https://clinicaltrials.gov/study/NCT05013073

ASTHMAXcel

TERMINATED

This protocol focuses on Phase 1 of a planned two-phase research project. Phase 1 aims to test and adapt a prototype ASTHMAXcelED application for the ED. Phase 2 will be an RCT to test the efficacy of a refined ASTHMAXcelED app after being modified based on the results of Phase 1.

NO

Asthma|Asthma Attack

OTHER: ASTHMAXcel ED Application

Asthma Control Test (ACT), A patient self-administered tool for identifying those with poorly controlled asthma., 4 Week Period

mini Asthma Quality of Life Questionnaire (mini AQLQ), Based on the 32 item AQLQ, the mini AQLQ is a 15-item self-administered tool constructed to meet the efficiency needs of large-scale clinical trials. The instrument was constructed for adults, and shown to have good reliability, responsiveness, construct and criterion validity. It captures functional impairments most relevant to adult asthma patients over a 2 week recall period. The tool is scored on a 7 point Likert scale, with increasing values corresponding with worsening quality of life., Recall over 2 week period|Unified Theory of Acceptance and use of Technology, UTAUT explains user intention and behavior regarding the adoption of new technology. It explains user interaction using 4 domains: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions. The model explained 70% of the variance in Behavioral Intention to Use (BI) and about 50% in actual use, and has been validated against eight similar models and across nine culturally diverse nations., Measured at 4 weeks after intervention

Open Ended Questions for ASTHMAXcelED Application Improvement, In order to iteratively improve the app and develop themes regarding user adoption, participants will be asked the following open ended questions and their answers transcribed in their entirety. How do you feel about using the app? Have you run into any issues using the app? Is it getting easier/harder to use the app over time? Which app features do you like? Which app features do you dislike? Which app features do you find difficult to use? How can the app be improved?, Measured at 4 weeks after intervention

Montefiore Medical Center

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2021-12692

2021-05-01

2023-02-07

2023-02-07

2021-08-19

2023-09-21

Montefiore Medical Center, Weiler Campus, Bronx, New York, 10461, United States|Montefiore Medical Center, Moses Campus, Bronx, New York, 10467, United States

{ "ASTHMAXcel ED Application": [ { "intervention_type": "OTHER" } ] }

NCT05954273

Maxillary Sinus Membrane Perforation Incidence During Osseodensification

https://clinicaltrials.gov/study/NCT05954273

ENROLLING_BY_INVITATION

Measure the incidence of the maxillary sinus membrane perforation during the Osseodensification crestal sinus grafting procedure.

NO

Sinus Floor Augmentation|Sinus Infection

PROCEDURE: Osseodensification crestal sinsus graft

Maxillary sinus membrane perforation rate during osseodensification crestal sinus grafting procedure., Measure the incidence of sinus membrane perforation during osseodensification, During augmentation surgery

Maxillary sinus augmentation level, The height and width of augmentation level, During augmentation surgery

Versah

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

ODSINUSPERF

2023-04-03

2023-07-31

2023-08-28

2023-07-20

2023-07-24

Versah, LLC, Jackson, Michigan, 49203, United States

{ "Osseodensification crestal sinsus graft": [ { "intervention_type": "PROCEDURE" } ] }

NCT06391073

Reach Out 2: Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems

https://clinicaltrials.gov/study/NCT06391073

NOT_YET_RECRUITING

Emergency department visits provide an opportunity to identify people with undiagnosed, untreated, or uncontrolled high blood pressure. In Reach Out, we will test whether a mobile health intervention yields a greater reduction in blood pressure than usual care among individuals identified with high blood pressure during a safety-net emergency department visit. Subsequently, we will estimate the reduction in heart attack, stroke, and dementia if Reach Out were implemented across all U.S. safety-net emergency departments.

NO

Hypertension

BEHAVIORAL: Self-Measured Blood Pressure Monitoring|BEHAVIORAL: Physician appointment and transportation scheduling

Change in systolic blood pressure, Change in 6-month Systolic Blood Pressure (SBP), 6 month

Change in diastolic blood pressure, Change in 6-month Diastolic Blood Pressure (DBP), 6 month|BP Control (130/80mmHg), Proportion of participants with controlled BP at 6-months. BP control is defined as BP less than 130/80 mmHg., 6 month

BP Control (140/90mmHg), Proportion of participants with controlled BP at 6-months. BP control defined as BP less than 140/90, 6 month|Initiation of antihypertensive medication, 6 month|Change in antihypertensive medication, 6 month|Establishment of primary care, Time from ED visit to arrival at first primary care visit, 6 month|Participant adherence with self-measured blood pressure monitoring, Proportion of BPs received after a BP prompt, 6 month

Northwestern University

University of Michigan|Ohio State University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

1R01MD019124

2024-06-01

2028-03-01

2028-11-30

2024-04-30

2024-05-02

Hurley Medical Center, Flint, Michigan, 48503, United States

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT06391073/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/73/NCT06391073/ICF_001.pdf

{ "Self-Measured Blood Pressure Monitoring": [ { "intervention_type": "BEHAVIORAL" } ], "Physician appointment and transportation scheduling": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT01984073

Effects of Niacin On Fatty Acid Trapping

https://clinicaltrials.gov/study/NCT01984073

NOFAT

COMPLETED

The purpose of this study is to understand whether a vitamin called NIcotinic ACid vitamIN (NIACIN for short, also known as vitamin B3) helps the body process dietary fat more efficiently. This is important because people with dyslipidemia have a problem with how they process fat, which raise the risk of heart disease.

NO

Dyslipidemia

DRUG: ER Niacin Oral Fat Challenge|DRUG: IR Niacin Oral Fat Challenge|OTHER: Placebo Oral Fat Challenge

Plasma Triglycerides, Plasma Triglycerides (TGs) after oral fat challenge will be measured to assess post-prandial lipidemia after niacin and placebo. Parameters of interest are the area under the curve (AUC), time to peak (t-max), and peak concentration (c-max). The relevant units will be mg.h/dl for plasma triglyceride AUC, minutes for time to peak plasma TG and mg/dl for c-max., Baseline to 12 hour post dose

University of Pennsylvania

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

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER

INTERVENTIONAL

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

NOFAT|K23HL091130

2012-12

2019-12

2019-12

2013-11-14

2020-07-09

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Presbyterian Hospital, Philadelphia, Pennsylvania, 19104, United States

{ "ER Niacin Oral Fat Challenge": [ { "intervention_type": "DRUG" } ], "IR Niacin Oral Fat Challenge": [ { "intervention_type": "DRUG" } ], "Placebo Oral Fat Challenge": [ { "intervention_type": "OTHER" } ] }

NCT02047773

Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations

https://clinicaltrials.gov/study/NCT02047773

BLTBrIV

COMPLETED

From the British Thoracic Guidelines1 and a PUBMED search there are no randomised controlled trials exploring optimum antibiotic duration for chest infections. The standard course of intravenous antibiotics for exacerbations of bronchiectasis is 14 days. This is a preliminary open labelled study to assess whether it is feasible to stop treatment earlier (day 8 or day 11) if the bacterial load is low or absent at days 7 or day 10 (it takes 24 hours for the results to be processed). All patients will therefore have a minimum of 7 days intravenous antibiotics. The intravenous antibiotic chosen is routinely used for exacerbations in bronchiectasis. Our hypothesis is that patients could have personalised treatment and be able to stop antibiotics when the sputum bacterial load is low (<10^6 colony forming units/ml (cfu/ml)).

NO

Bronchiectasis

OTHER: Duration|DRUG: Colomycin|DRUG: Meropenem

Time to next exacerbation, The time to next exacerbation (all the patients are followed up in the bronchiectasis clinic and record the date of their exacerbations where they receive antibiotic therapy)., up to 1 year following IV antibiotics|Proportion of patients that stopped antibiotics early, The proportion of patients where we can stop antibiotic treatment early guided by bacterial load either on day 8 or day 11 instead of usual day 14 course. All patients will have a minimum of 7 days of intravenous antibiotics., 14 days

Clinical recovery at days 14 and 21, Clinical recovery defined in this study is based on our clinical experience and our study evaluating useful endpoints in monitoring exacerbations. Clinical recovery is defined as: patients feeling better (quantitatively assessed using a 4 point or more improvement in St George s Respiratory Questionnaire or a 1.3 unit improvement or more in the Leicester Cough Questionnaire) and either a reduction in sputum purulence (purulent to mucopurulent, mucoid or no sputum; or mucopurulent to mucoid or no sputum) or a 50% reduction or more in 24 hour sputum volume. The reason for the two options here is that in clinical practice, some patients sputum purulence does not change but have a significant reduction in sputum volume., 21 days|Correlation of bacterial load with clinical response, The correlation of clinical response and reduction in bacterial load (sputum colour and volume, systemic inflammation, pulmonary physiology and assessment of exercise capacity), 21 days|Antibiotic side effects, Patients will be asked to report any side effects from the treatment and at what day these effects occurred., 14 days

University of Edinburgh

NHS Lothian

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

BLTBrIVStudy

2014-01

2020-02-01

2020-02-01

2014-01-28

2020-05-04

Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, United Kingdom

{ "Duration": [ { "intervention_type": "OTHER" } ], "Colomycin": [ { "intervention_type": "DRUG" } ], "Meropenem": [ { "intervention_type": "DRUG", "description": "Meropenem", "name": "Meropenem", "synonyms": [ "Ronem", "SM7338", "Merrem", "Meropenem anhydrous", "SM 7338", "(4R,5S,6S)-3-{[(3S,5S)-5-(dimethylcarbamoyl)pyrrolidin-3-yl]thio}-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid", "SM-7338", "3-(5-Dimethylcarbamoylpyrrolidin-3-ylthio)-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid", "Meropenem", "Meropenemum", "Penem" ], "medline_plus_id": "a696038", "generic_names": [ "Meropenem" ], "mesh_id": "D000900", "drugbank_id": "DB00760" } ] }

NCT00023673

Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer

https://clinicaltrials.gov/study/NCT00023673

COMPLETED

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them with specialized radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.

YES

Lung Cancer

DRUG: carboplatin|DRUG: paclitaxel|RADIATION: three-dimensional conformal radiation therapy

Maximum Tolerated Dose (MTD) of Three-dimensional Conformal Radiation Therapy (3DRT), in Terms of Gy Per Fraction, Combined With Concurrent Chemotherapy, Dose limiting toxicity (DLT) = Grade 3/4 non-hematologic toxicities (excluding nausea, vomiting, and alopecia) and Grade 4 hematologic toxicities. The DLT rate for this study was set at 40% based on Radiation Therapy Oncology Group (RTOG) study 94-10. No acute (within 90 days from start of 3DRT) DLT s in the first 5 patients (0/5) or the combination of one acute DLT in the first 5 patients (1/5) and none in the next 2 patients (0/2) was required to deem a given dose level to be acceptable. If at any time a Grade 5 toxicity (death) occurred, accrual would be suspended and the event reviewed by a study chair. At any given dose level, this design gives at least 90% confidence that the true acute DLT rate is less than 40% and the probability of not escalating when the true toxicity rate is 40% or higher is at least 83%. Rating scale: 0 = not the MTD, 1 = MTD, From start of treatment to 90 days|Percentage of Patients Who Survive at Least 12 Months, Null hypothesis: p<= 62.3% (the best arm of RTOG 94-10); alternative hypothesis: p>= 77.9%. Where p is the percentage of patients alive at at 12 months. Using a one-group chi-square test with alpha = 0.10, a sample size of 50 patients provides at least 87% power to detect a 25% or greater relative increase in the 12-month survival rate, or equivalently, an absolute increase of at least 15.6 percentage points (62.3 versus 77.9). If the point estimate is greater than 71.1% (upper bound), then the conclusion is that the 12-month survival rate from the new treatment significantly improved from 62.3%., From registration to 1 year

Frequency of Highest Grade Chemotherapy/Acute RT Toxicities and Late RT Toxicities., Highest grade toxicity per subject was counted. Toxicities were graded using the Common Toxicity Criteria (CTC) v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity.Chemotherapy/Acute RT toxicities occur during chemotherapy and/or within 90 days of the start of RT. Late RT toxicities occur more than 90 days after the start of RT., Chemotherapy/Acute RT toxicity: from start of treatment to 90 days from start of study treatment; Late RT toxicity: from 90 days after start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|Partial Organ Tolerance Doses for Lung and Esophagus (Percent Volume of Total Lung Receiving > 20 Gy by Toxicity Level), Percent volume of total lung receiving > 20 Gy radiation therapy (Lung V20) was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, it was also compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity., From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|Partial Organ Tolerance Doses for Lung and Esophagus (Mean Organ Dose by Toxicity Level), Mean lung dose was compared between the two patient groups of those who experienced a grade 3 and higher lung toxicity and those who did not. Similarly, mean lung dose, and mean esophageal dose were compared between the two patient groups of those who experienced a grade 2 and higher esophageal toxicity and those who did not. Toxicities graded using CTC v 2.0 for chemotherapy/acute RT toxicities and using the RTOG/EORTC Late Toxicity Criteria for late RT toxicity. Grade refers to the severity of the toxicity. Both criteria assign Grades 1 through 5 with unique clinical descriptions of severity for a given toxicity based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to toxicity., From start of treatment to last follow-up (Maximum follow-up = 57.9 months.)|Number of Patients With Complete Response at 3 Months After Completion of Therapy, Complete response means no evidence of tumor on the CT scan., From start of treatment until 3 months after completion of all study treatment, estimated to be 5 or 6.5 months depending whether or not subject received optional adjuvant chemotherapy.

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

ALL

CHILD, ADULT, OLDER_ADULT

PHASE1|PHASE2

NETWORK

INTERVENTIONAL

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

RTOG L-0117|CDR0000068850|NCI-2012-02401

2001-07

2009-01

2013-11

2003-04-09

2014-03-27

2017-12-22

Mobile Infirmary Medical Center, Mobile, Alabama, 36652-2144, United States|Arizona Oncology Services Foundation, Phoenix, Arizona, 85013, United States|Providence Saint Joseph Medical Center - Burbank, Burbank, California, 91505, United States|Providence Holy Cross Cancer Center, Mission Hills, California, 91346-9600, United States|University of California Davis Cancer Center, Sacramento, California, 95817, United States|Bay Medical, Panama City, Florida, 32401, United States|Northeast Georgia Medical Center, Gainesville, Georgia, 30501, United States|Saint Anthony s Hospital at Saint Anthony s Health Center, Alton, Illinois, 62002, United States|Alexian Brothers Radiation Oncology, Elk Grove Village, Illinois, 60007, United States|Good Samaritan Regional Health Center, Mount Vernon, Illinois, 62864, United States|Oncology Center at Saint Margaret Mercy Healthcare Center, Hammond, Indiana, 46320, United States|Cancer Center at Ball Memorial Hospital, Muncie, Indiana, 47303-3499, United States|Regional Cancer Center at Singing River Hospital, Pascagoula, Mississippi, 39581, United States|Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital, Cape Girardeau, Missouri, 63701, United States|Cancer Institute of Cape Girardeau, LLC, Cape Girardeau, Missouri, 63703, United States|Saint Francis Medical Center, Cape Girardeau, Missouri, 63703, United States|CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, 63141, United States|David C. Pratt Cancer Center at St. John s Mercy, Saint Louis, Missouri, 63141, United States|CCOP - Cancer Research for the Ozarks, Springfield, Missouri, 65802, United States|Hulston Cancer Center at Cox Medical Center South, Springfield, Missouri, 65807, United States|Ocean Medical Center at Meridian Health, Brick, New Jersey, 08724, United States|J. Phillip Citta Regional Cancer Center at Community Medical Center, Toms River, New Jersey, 08755, United States|Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare, Vineland, New Jersey, 08360, United States|CCOP - Hematology-Oncology Associates of Central New York, East Syracuse, New York, 13057, United States|High Point Regional Hospital, High Point, North Carolina, 27261, United States|Summa Center for Cancer Care at Akron City Hospital, Akron, Ohio, 44309-2090, United States|Cleveland Clinic Cancer Center at Fairview Hospital, Cleveland, Ohio, 44111, United States|Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, 44195, United States|Cancer Treatment Center, Wooster, Ohio, 44691, United States|Three Rivers Community Hospital, Grants Pass, Oregon, 97527, United States|Dubs Cancer Center at Rogue Valley Medical Center, Medford, Oregon, 97504, United States|Providence Cancer Center at PMCC, Medford, Oregon, 97504, United States|Albert Einstein Cancer Center, Philadelphia, Pennsylvania, 19141, United States|Rapid City Regional Hospital, Rapid City, South Dakota, 57701, United States|University of Texas Medical Branch, Galveston, Texas, 77555-0361, United States|Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, 79410-1894, United States|Schiffler Cancer Center at Wheeling Hospital, Wheeling, West Virginia, 26003, United States|Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center, La Crosse, Wisconsin, 54601, United States|Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, 53226, United States|Veterans Affairs Medical Center - Milwaukee, Milwaukee, Wisconsin, 53295, United States|Tom Baker Cancer Centre - Calgary, Calgary, Alberta, T2N 4N2, Canada

{ "Carboplatin": [ { "intervention_type": "DRUG", "description": "carboplatin", "name": "Carboplatin", "synonyms": [ "Carboplatino", "Carboplatin", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum", "cis-diammine(1,1-cyclobutanedicarboxylato)platinum(II)", "Paraplatin", "Carboplatine", "cis-(1,1-cyclobutanedicarboxylato)diammineplatinum(II)", "CBDCA" ], "medline_plus_id": "a695017", "generic_names": [ "Carboplatin" ], "drugbank_id": "DB00958" } ], "Paclitaxel": [ { "intervention_type": "DRUG", "description": "paclitaxel", "name": "Paclitaxel", "synonyms": [ "liposomal encapsulated paclitaxel", "7-epi-Taxol", "BENZENEPROPANOIC ACID, .BETA.-(BENZOYLAMINO)-.ALPHA.-HYDROXY-, (2AR,4S,4AS,6R,9S,11S,12S,12AR,12BS)-6,12B-BIS(ACETYLOXY)-12-(BENZOYLOXY)-2A,3,4,4A,5,6,9,10,11,12,12A,12B-DODECAHYDRO-4,11-DIHYDROXY-4A,8,13,13-TETRAMETHYL-5-OXO-7,11-METHANO-1H-CYCLODECA(3,", "NSC-125973", "Anzatax", "Bris Taxol", "Paxene", "Taxol A", "NAB-PACLITAXEL COMPONENT PACLITAXEL", "7 epi Taxol", "NSC125973", "Paclitaxel", "Onxol", "Praxel", "Paclitaxel, (4 alpha)-Isomer", "Taxol", "NSC 125973", "paclitaxel protein-bound particles", "Taxol, Bris", "ABI-007 COMPONENT PACLITAXEL", "5beta,20-Epoxy-1,2-alpha,4,7beta,10beta,13alpha-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine", "Nanoparticulate paclitaxel", "Paclitaxel protein-bound particles for injection suspension", "Taxol", "Paclitaxel (with polyoxyethylated castor oil)", "Taxol", "Paclitaxel (with polyoxyethylated castor oil)" ], "mesh_id": "D050257", "generic_names": [ "Paclitaxel", "Paclitaxel (with polyoxyethylated castor oil)", "Paclitaxel (with polyoxyethylated castor oil)" ], "drugbank_id": "DB01229" } ], "three-dimensional conformal radiation therapy": [ { "intervention_type": "RADIATION" } ] }

NCT02296073

The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.

https://clinicaltrials.gov/study/NCT02296073

UNKNOWN

To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.

NO

Failed Conscious Sedation During Procedure

DRUG: Midazolam|DRUG: Dexmedetomidine|DRUG: Dexmedetomidine|DRUG: Dexmedetomidine|DRUG: Fentanyl|OTHER: assessment

percentage of time at target sedation score, assess the sedation level every 2 min using Ramsay score, up to 24 hours|the number of patients requiring the sedation remedy, the number of patients requiring the sedation remedy during the mechanical ventilation, up to 24 hours|the dosage of midazolam that need for the sedation remedy, the dosage of midazolam that need for sedation remedy during the mechanical ventilation, up to 24 hours

change of blood pressure, the change of blood pressure at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used., up to 24 hours.|change of heart rate, the change of heart rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used., up to 24 hours|change of respiratory rate, the change of respiratory rate at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used., up to 24 hours|change of blood oxygen saturation, the change of blood oxygen saturation at 1 min、10 min、20 min、30 min、1 hours、2 hours、3 hours、4 hours、5 hours、6 hours、12 hours、18 hours、24 hours after the sedation drug used., up to 24 hours|extubation time, time from beginning of study drug used to extubation, up to 24 hours|change of hepatic function, change of blood ALT、AST level at baseline and 24 hours after the sedation drug used., up to 24 hours|change of renal function, change of blood Cr、BUN level at baseline and 24 hours after the sedation drug used., up to 24 hours|the dosage of sedation and analgesia drug, the total dosage of sedation and analgesia drug during the sedation and analgesia period, up to 24 hours|the number of patients requiring fentanyl analgesia in and after 6 hours from study drug used, up to 24 hours|the dosage of fentanyl in and after 6 hours from study drug used, up to 24 hours

Anhui Provincial Children s Hospital

ALL

CHILD

PHASE4

OTHER

INTERVENTIONAL

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

PICUDEX2014

2014-12

2014-12

2015-12

2014-11-20

2014-11-21

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

NCT05821673

Soft Tissue Integration of Different Abutment Surfaces

https://clinicaltrials.gov/study/NCT05821673

COMPLETED

Objective of the present study was to assess the peri-implant soft tissue profiles between argon plasma pre-treated (PT) and non-treated (NPT) abutments by comparing clinical and histological parameters 2 months after abutment placement.

NO

Edentulous Alveolar Ridge|Soft Tissue Healing

PROCEDURE: Argon plasma pre-treated abutment insertion|PROCEDURE: abutment insertion

Histological and immunohistochemical assessment, soft peri-implant tissues and abutment were harvested and histologically processedSpecialized stainings (hematoxylin eosin and picrocirious red) coupled with immunohistochemistry (vimentin, collagen, and CK10) were performed to assess soft tissue inflammation and healing, as well as the collagen content keratinization., 2 months after abutment placement|Plaque index (PI), PI scores were recorded in 6 points around each abutment, averaged, and expressed in %. PI was evaluated with a score of 0,1,2, 3 depending on the amount of plaque at each site., 2 months after abutment placement|Bleeding on probing (BoP), BoP scores were recorded in 6 points around each abutment, averaged, and expressed in %.BoP was used as a dichotomous variable, 2 months after abutment placement

Studio Odontoiatrico Associato Dr. P. Cicchese e L. Canullo

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

DD-02

2021-06-21

2021-12-18

2022-06-30

2023-04-20

2023-04-20

Studio Odont.Associato Dr.P.Cicchese E L.Canullo, Rome, Italy/Rome, 00198, Italy

{ "Argon plasma pre-treated abutment insertion": [ { "intervention_type": "PROCEDURE" } ], "abutment insertion": [ { "intervention_type": "PROCEDURE" } ] }

NCT00648973

To Determine if Diphenhydramine Works for Nasal Congestion at Two Different Doses

https://clinicaltrials.gov/study/NCT00648973

COMPLETED

The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.

NO

Nasal Congestion

DRUG: Diphenhydramine 50 mg|DRUG: Diphenhydramine 25 mg|DRUG: Pseudoephedrine 120 mg

Change from baseline in the subject s mean reflective nasal congestion/stuffiness symptom score, every 12-hours over the 14-day treatment period

Change from baseline in the subject s mean reflective Total Nasal Symptom (TNS) Score, 14 Days|Change from baseline in the subject s mean instantaneous TNS Score, 14 Days|Change from baseline in the subject s mean reflective Total SAR Symptom (TSS) Score, 14 Days|Change from baseline in the subject s mean instantaneous TSS Score, 14 Days|Change from baseline in the subject s mean reflective score for each of the seven remaining individual SAR symptoms, excluding nasal congestion/stuffiness, 14 Days|Change from baseline in the subject s mean instantaneous score for each of the eight individual SAR symptoms, 14 Days|Onset of action for diphenhydramine treatment for nasal congestion/stuffiness was determined by comparing the change from baseline in the subject s instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo, taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose.|Onset of action for diphenhydramine treatment for allergic rhinitis symptoms was determined by comparing the change from baseline in the subject s instantaneous TNS scores for diphenhydramine versus placebo, taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose|Duration of action for diphenhydramine for treatment of nasal congestion/stuffiness was evaluated by comparing the change from baseline in the subject s mean instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo, taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)|Duration of action for diphenhydramine for treatment of allergic rhinitis symptoms was evaluated by comparing the change from baseline in the subject s mean instantaneous TNS scores for diphenhydramine versus placebo, taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose)|Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints, 14 Days|Subject s global evaluation of response to treatment, at Visits 3 and 4, analyzed separately at each visit|Change from baseline in the Investigator s TNS score, at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1|Change from baseline in the Investigator s TSS score, at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1|Change from baseline for each of the eight individual Investigator s SAR symptoms, at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1|Investigator s global evaluation of the subject s response to treatment, at Visits 3 and 4, analyzed separately for each visit|Number and percentage of subjects experiencing adverse events, Duration of study|Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate), Duration of study|Occurrence of somnolence, Overall and weekly

Johnson & Johnson Consumer and Personal Products Worldwide

ALL

CHILD, ADULT, OLDER_ADULT

PHASE4

INDUSTRY

INTERVENTIONAL

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

A2341002

2006-11

2007-05

2007-05

2008-04-01

2011-08-22

Benchmark Research - Austin, Austin, Texas, 78705, United States|Allergy and Asthma Associates, Austin, Texas, 78731, United States|Lovelace Scientific Resources, Austin, Texas, 78759, United States|Allergy/Immunology Research Center of North Texas, Dallas, Texas, 75230, United States|Kerrville Research Associates, Kerrville, Texas, 78028, United States|Central Texas Health Research, New Braunfels, Texas, 78130, United States|Benchmark Research - San Angelo, San Angelo, Texas, 76904, United States|Sun Research Institute, San Antonio, Texas, 78205, United States|Biogenics Research Institute, San Antonio, Texas, 78229, United States|Diagnostics Research Group, San Antonio, Texas, 78229, United States|Sylvana Research Associates, San Antonio, Texas, 78229, United States|Allergy Asthma Research Institute, Waco, Texas, 76712, United States

{ "Diphenhydramine": [ { "intervention_type": "DRUG", "description": "Diphenhydramine 50 mg", "name": "Diphenhydramine", "synonyms": [ "Diphenadryl", "Siladryl", "Diphenylhydramin", "2-Diphenylmethoxy-N,N-dimethylethylamine", "Benhydramin", "Afterbite with Antihistamine", "Diphenhydramine Citrate", "Citrate, Diphenhydramine", "2-(benzhydryloxy)-N,N-dimethylethylamine", "Diphedryl", "Nytol Original", "Diphenhydramine", "Diphenhydramine Citrate (1:1)", "Diphenhydramine Hydrochloride", "Dormin", "Difenhidramina", "Compoz Nighttime Sleep Aid", "2-diphenylmethoxy-N,N-demthylethanamine", "N-(2-(diphenylmethoxy)ethyl)-N,N-dimethylamine", "Diphenhydraminum", "Aler-Dryl", "Benadryl", "Pardryl", "Dimedrol", "Banophen", "Allerdryl", "Diphenylin", "Benylin", "Benzhydramine", "Diphenylhydramine", "Boots Sleepeaze", "\u03b2-dimethylaminoethyl benzhydryl ether", "\u03b2-dimethylaminoethanol diphenylmethyl ether", "Hydramine", "O-benzhydryldimethylaminoethanol", "\u03b1-(2-dimethylaminoethoxy)diphenylmethane", "Sominex", "Allermax", "Hydrochloride, Diphenhydramine", "Pipolphen", "Phenargan", "- OtherAvomine", "Promethazine Hydrochloride", "Hydrochloride, Promethazine", "Promethazine", "Diphergan", "Atosil", "Pyrethia", "Rumergan", "N-(2'-dimethylamino-2'-methyl)ethylphenothiazine", "Prometazin", "Pipolfen", "Diprazin", "Promethazinum", "(2-dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine", "10-(2-Dimethylaminopropyl)phenothiazine", "Phensedyl", "Prometazina", "Promet", "Isopromethazine", "Prothazin", "N,N,alpha-trimethyl-10H-phenothiazine-10-ethanamine", "Remsed", "Phenergan", "Proazamine", "N,N,\u03b1-trimethyl-10H-phenothiazine-10-ethanamine", "10-[2-(dimethylamino)propyl]phenothiazine", "Sominex", "Pipolphen", "Phenargan", "- OtherAvomine", "Promethazine Hydrochloride", "Hydrochloride, Promethazine", "Promethazine", "Diphergan", "Atosil", "Pyrethia", "Rumergan", "N-(2'-dimethylamino-2'-methyl)ethylphenothiazine", "Prometazin", "Pipolfen", "Diprazin", "Promethazinum", "(2-dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine", "10-(2-Dimethylaminopropyl)phenothiazine", "Phensedyl", "Prometazina", "Promet", "Isopromethazine", "Prothazin", "N,N,alpha-trimethyl-10H-phenothiazine-10-ethanamine", "Remsed", "Phenergan", "Proazamine", "N,N,\u03b1-trimethyl-10H-phenothiazine-10-ethanamine", "10-[2-(dimethylamino)propyl]phenothiazine", "Sominex" ], "medline_plus_id": "a601044", "generic_names": [ "Diphenhydramine", "Promethazine", "Promethazine" ], "nhs_url": "https://www.nhs.uk/medicines/diphenhydramine", "mesh_id": "D000068776", "drugbank_id": "DB01075" }, { "intervention_type": "DRUG", "description": "Diphenhydramine 25 mg", "name": "Diphenhydramine", "synonyms": [ "Diphenadryl", "Siladryl", "Diphenylhydramin", "2-Diphenylmethoxy-N,N-dimethylethylamine", "Benhydramin", "Afterbite with Antihistamine", "Diphenhydramine Citrate", "Citrate, Diphenhydramine", "2-(benzhydryloxy)-N,N-dimethylethylamine", "Diphedryl", "Nytol Original", "Diphenhydramine", "Diphenhydramine Citrate (1:1)", "Diphenhydramine Hydrochloride", "Dormin", "Difenhidramina", "Compoz Nighttime Sleep Aid", "2-diphenylmethoxy-N,N-demthylethanamine", "N-(2-(diphenylmethoxy)ethyl)-N,N-dimethylamine", "Diphenhydraminum", "Aler-Dryl", "Benadryl", "Pardryl", "Dimedrol", "Banophen", "Allerdryl", "Diphenylin", "Benylin", "Benzhydramine", "Diphenylhydramine", "Boots Sleepeaze", "\u03b2-dimethylaminoethyl benzhydryl ether", "\u03b2-dimethylaminoethanol diphenylmethyl ether", "Hydramine", "O-benzhydryldimethylaminoethanol", "\u03b1-(2-dimethylaminoethoxy)diphenylmethane", "Sominex", "Allermax", "Hydrochloride, Diphenhydramine", "Pipolphen", "Phenargan", "- OtherAvomine", "Promethazine Hydrochloride", "Hydrochloride, Promethazine", "Promethazine", "Diphergan", "Atosil", "Pyrethia", "Rumergan", "N-(2'-dimethylamino-2'-methyl)ethylphenothiazine", "Prometazin", "Pipolfen", "Diprazin", "Promethazinum", "(2-dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine", "10-(2-Dimethylaminopropyl)phenothiazine", "Phensedyl", "Prometazina", "Promet", "Isopromethazine", "Prothazin", "N,N,alpha-trimethyl-10H-phenothiazine-10-ethanamine", "Remsed", "Phenergan", "Proazamine", "N,N,\u03b1-trimethyl-10H-phenothiazine-10-ethanamine", "10-[2-(dimethylamino)propyl]phenothiazine", "Sominex", "Pipolphen", "Phenargan", "- OtherAvomine", "Promethazine Hydrochloride", "Hydrochloride, Promethazine", "Promethazine", "Diphergan", "Atosil", "Pyrethia", "Rumergan", "N-(2'-dimethylamino-2'-methyl)ethylphenothiazine", "Prometazin", "Pipolfen", "Diprazin", "Promethazinum", "(2-dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine", "10-(2-Dimethylaminopropyl)phenothiazine", "Phensedyl", "Prometazina", "Promet", "Isopromethazine", "Prothazin", "N,N,alpha-trimethyl-10H-phenothiazine-10-ethanamine", "Remsed", "Phenergan", "Proazamine", "N,N,\u03b1-trimethyl-10H-phenothiazine-10-ethanamine", "10-[2-(dimethylamino)propyl]phenothiazine", "Sominex" ], "medline_plus_id": "a601044", "generic_names": [ "Diphenhydramine", "Promethazine", "Promethazine" ], "nhs_url": "https://www.nhs.uk/medicines/diphenhydramine", "mesh_id": "D000068776", "drugbank_id": "DB01075" } ], "Pseudoephedrine 120 mg": [ { "intervention_type": "DRUG" } ] }

NCT03746873

Increase Level of Physical Activity and Decrease Use of Health Care for People With COPD

https://clinicaltrials.gov/study/NCT03746873

COPD

COMPLETED

This study evaluates the effects of the COPD Web (KOLwebben), an interactive web-based tool directed towards people with chronic obstructive pulmonary disease (COPD). The COPD Web include tools that improve health literacy with a specific focus on 1) increased physical activity and 2) use of appropriate self-management strategies. This randomized clinical trial aims to generate evidence on the effect and usability of the COPD Web in a properly powered cohort of patients in primary care context.

NO

Pulmonary Disease, Chronic Obstructive

BEHAVIORAL: COPD Web

Change in level of objectively measured physical activity, Level of physical activity will be objectively measured with an activity monitor, the DynaPort MiniMod. The activity monitor data collected during 7 Days at baseline and 7 Days 3- and 12- months after baseline will be used to assess change in level of physical activity., 7 Days at baseline, 7 days at 3- and 12- months after baseline

Change in level of subjectively assessed physical activity, Level of physical activity will be subjectively assessed with Socialstyrelsens indicator questions on physical activity., 7 Days at baseline, 7 days at 3- and 12- months after baseline|Change in subjectively assessed dyspnea severity, Dyspnea severity will be assessed using the modified Medical Research Council dyspnea scale (mMRC), 7 Days at baseline, 7 days at 3- and 12- months after baseline|Change in subjectively assessed COPD-related symptoms, Change in COPD-related symptoms will be assessed using the COPD assessment test (CAT)., 7 Days at baseline, 7 days at 3- and 12- months after baseline|Change in subjectively assessed health related quality of life, Change in health related quality of life will be assessed using the Chronic Respiratory Questionnaire, self-administered (CRQ-SA), 7 Days at baseline, 7 days at 3- and 12- months after baseline|Change in health economics using subjectively assessed EQ-5D in combination with self-reported health care contacts, Evaluation of health economics will be done using EQ-5D in combination with the number of COPD-related health care contacts that will be self-reported., 7 Days at baseline, 7 days at 3- and 12- months after baseline

Enablers and barriers for the use of COPD Web in order to change behavior., Semi structured interviews and content analysis will be performed in a subgroup of patients randomized to intervention to identify enablers and barriers for the use of an eHealth solution like COPD Web in order to change behavior. The patients will receive a question to take part in an interview at the 3 month follow up., 3 months after baseline

Umeå University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

KOLwebben1

2018-11-15

2022-06-08

2022-06-08

2018-11-20

2023-12-08

Umeå university, Umeå, Sweden

Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT03746873/SAP_000.pdf

{ "COPD Web": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05078073

HBOT in the Treatment and Prevention of aGVHD

https://clinicaltrials.gov/study/NCT05078073

RECRUITING

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is a potentially curative therapeutic strategy for patients with hematopoietic malignancies. However, the therapeutic benefits and wider application of allo-HSCT are limited by acute graft-versus-host disease (aGVHD), the latter remains a major obstacle against long-term survival for this population. New aGVHD prophylactic and therapeutic strategies that are superior in efficacy, safety, cost-effectiveness, and less technically demanding are still in desperate need. Hyperbaric oxygen therapy (HBOT) has been confirmed as an effective and economical therapeutic modality for hemorrhagic cystitis (HC) whether induced by infection or acute graft-versus-host disease (aGVHD) for transplant recipients. However, little is known about its involvement in aGVHD. In this study, the investigators designed a randomized, controlled, and open clinical trial to confirm the safety and efficacy of HBOT on aGVHD in patient underwent allo-HSCT.

NO

Hyperbaric Oxygen Therapy|Acute-graft-versus-host Disease

DEVICE: Hyperbaric oxygen therapy

Overall response rate of HBOT as complete response or partial response for the treatment of aGVHD, Complete or partial response rate of HBOT for the treatment of aGVHD will be measured using Bayesian method., Four years|Incidence of aGVHD when HBOT was administrated as prophylaxis measurement at one month after transplant, At one month after transplant, HBOT will be administrated every three days (up to 6 times) to recipients without aGVHD evidence, the incidence of aGVHD will be counted., 100 days post transplant

Overall survival rate, Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes., Four years|Leukemia-free survival rate, Will be summarized by frequency and 95% confidence interval. The distribution of time-to-event endpoints will be estimated by Kaplan-Meier estimate. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazards regression will be employed for multivariate analysis on time-to-event outcomes., Four years|Relapse rate, Relapse rate of recipients will be measured using Bayesian method. Will be summarized by frequency and 95% confidence interval., Four years|Incidence of adverse events of HBOT, Toxicities will be summarized by grade and by their relationship to treatment., Four years

Shandong Provincial Hospital

ALL

CHILD, ADULT, OLDER_ADULT

OTHER_GOV

INTERVENTIONAL

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

HBOT in aGVHD

2021-10-10

2024-08-10

2025-08-10

2021-10-14

2021-10-14

Shandong Provincial Hospital, Jinan, Shandong, 250021, China

{ "Hyperbaric oxygen therapy": [ { "intervention_type": "DEVICE" } ] }

NCT04948073

The Effects of Dynamic Neuromuscular Stabilization Approach

https://clinicaltrials.gov/study/NCT04948073

COMPLETED

When the positive effects of the recently popular Dynamic Neuromuscular Stabilization (DNS) approach are examined, it suggests that it may be a possible treatment option in geriatric individuals with chronic nonspecific low back pain (CSNLP). Based on the principles of developmental kinesiology, the DNS approach takes advantage of infants motor development curves in the treatment of motor disorders. The main focus is on regulating intra-abdominal pressure and the integrated spinal stabilizing system (ISSS) through specific functional exercises based on the positions exhibited by a healthy infant. According to the DNS, every developmental position is an exercise position, but every exercise must follow basic principles. These principles are restoration of correct respiratory pattern and intra-abdominal pressure, respectively; ensuring correct support during dynamic activities of the extremities and ensuring biomechanical alignment during movement. Considering the principles of exercise, there appears to be a potential mechanism of action for anomalies in geriatric individuals with CNSLBP. Therefore, in our study, we aimed to examine the effect of DNS approach on functional movement patterns, balance, quality of life and exercise capacity in geriatric individuals with CNSLBP. It is the first randomized controlled study in the literature, and our hypothesis is that the DNS approach may be an effective therapeutic approach on these parameters.

NO

Low Back Pain|Rehabilitation|Treatment

OTHER: Dynamic neuromuscular stabilization approach|OTHER: Conventional treatment

Functional Movement Screening (FMS) [Functional Movement Patterns), FMS will be used to evaluate the quality of 7 functional movement patterns with the goal of identifying movement limitations and asymmetries. The FMS consists of 7 individual test items including the deep squat, in-line lunge, hurdle step, shoulder flexibility, push-up, straight leg raise, and rotary trunk stability assessment. Each of these 7 test items is graded on a scale of 0-3; thus, the lowest and highest possible overall FMS scores are 0 and 21, respectively., 6 weeks|6-Minute Walk Test (6MWT) [Exercise Capacity], 6MWT is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.It provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions. Main strengths of the 6MWT stem from its simplicity in concept and performance, low cost, ease of standardization, and acceptance by test subjects, including those who are deconditioned, elderly, or frail., 6 weeks

Timed-up and go Test (TUG) [Balance], TUG is a simple test used to assess a person s mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. During the test, the person is expected to wear their regular footwear and use any mobility aids that they would normally require. The TUG is used frequently in the elderly population, as it is easy to administer and can generally be completed by most older adults., 6 weeks|WHOQOL-OLD module [Quality of life], It consists of 24 items assigned to 6 dimensions, the responses to which are determined by the five-level Likert scale. Higher scores indicate better quality of life., 6 weeks

Hacettepe University

ALL

OLDER_ADULT

OTHER

INTERVENTIONAL

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

2021500

2021-06-24

2022-04-04

2022-04-11

2021-07-01

2022-04-22

Kırşehir Ahi Evran University, Kırşehir, 40100, Turkey

{ "Dynamic neuromuscular stabilization approach": [ { "intervention_type": "OTHER" } ], "Conventional treatment": [ { "intervention_type": "OTHER" } ] }

NCT05235373

Prognostic Significance of COVID-19 MSCT Chest Findings on Short Term Disease Progression

https://clinicaltrials.gov/study/NCT05235373

MSCT

COMPLETED

Background: CT has been used on a massive scale to help identify and investigate suspected or confirmed cases of COVID-19 pneumonia. This study aimed to assess the prognostic significance of the chest findings MSCT of Covid-19 patients and to determine if prognosis can rely on the initial CT imaging. Methods: The study design was retrospective cohort study. It was carried out on 300 patients presented to the chest outpatient clinics in Benha university hospitals and Elabbasyia chest hospital with clinical picture suggestive of COVID 19 infection. The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive. According to the progression of the respiratory symptoms (include; dyspnea, respiratory rate and O2 saturation), the short-term clinical outcome of the patients was classified into 4 groups; Group A: (mild cases), Group B: (moderate cases), Group C: (sever cases), and Group D: (fatality cases).

NO

COVID-19|Infection Viral

correlation between initial CT findings with short term clinical outcome, The CT finding were then compared to the short-term clinical outcome of the patients (1-3weeks), acquired from the hospital patient data archive; respiratory symptoms (dyspnea, respiratory rate and O2 saturation),, 3 weeks

Benha University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

TEJB-D-22-00019

2020-04-01

2020-12-30

2021-10-15

2022-02-11

2022-02-11

Benha University hospital, Banhā, Kalyobia, 13512, Egypt

{}

NCT05334173

Gastric Bypass With Different Lengths of the Bilipancreatic Limb

https://clinicaltrials.gov/study/NCT05334173

BPG-1

ACTIVE_NOT_RECRUITING

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) has been the most performed bariatric surgical intervention until a few years ago, due to its good results in terms of weight loss and remission of comorbidities such as hypertension, type 2 diabetes mellitus, dyslipidemia and obstructive sleep apnea syndrome. However, more than 25% of patients do not obtain the expected result. There is no uniform technique to perform a LRYGB, but traditionally it was constructed using a long alimentary limb (AL) and a short biliopancreatic limb (BPL). There is no current consensus on the ideal length of the LRYGB limbs. The distal gastric bypass at the expense of a longer biliopancreatic limb (LBPL-GB) could induce more excess of weight loss (EWL%), but with possible protein malnutrition depending on the length of the remaining common limb. The aim of this study is compare a LBPL-GB (BPL 150cm, AL 70cm) with LAL-GB (BPL 70cm, AL 150cm). PRIMARY OUTCOME: to evaluate if there are differences in weight loss. SECONDARY OUTCOME: to assess whether there are differences in both groups in remission of the most common comorbidities and in quality of life. DESIGN: multicenter, prospective, randomized study in blocks (1:1), blinded for the patient and to the surgeon up to the time of intervention, in patients with indication of RYGB for obesity (BMI>35 with associated comorbidity or BMI>40 with or without comorbidity, excluding those of BMI>50). Intervention: LRYGB type 1 (LAL-GB: 150cm ALand 70cm BPL) or type 2 (LBPL-GB: 70cm AL and 150cm BPL). The expected result is that the patients with LBPL-GB present better EWL%, and higher remission of their comorbidities than the comparison group

NO

Laparoscopic-Roux-en-Y Gastric Bypass|Obesity|Diabetes Mellitus, Type 2|Hypertension|Dyslipidemias|Sleep Apnea

PROCEDURE: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb

Excess Weight Loss (%EWL), The Excess Weight Loss (%EWL) after surgery. (Preoperatory weight in kilograms - current weight in kilograms) / (preoperatory weight in kilograms) x 100, From baseline to five years after surgery

Remission or improvement of Type 2 Diabetes Mellitus, Remission or improvement of Type 2 Diabetes Mellitus after surgery, according to the Criteria of American Diabetes Association, Spanish Obesity Surgery Society and Spanish Surgeon Association. Complete remission: HbA1c < 6% and normalization of fasting blood glucose (100 mg/dl) without medication during one year minimum. Partial remission: HbA1c 6-6.5% and fasting blood glucose between 100 and 125 mg/dl) without medication. Prolonged remission: at least 5 years of remission. Improvement HbA1c < 7%, with pharmacological treatment. ADA criteria (American Diabetes Association), From baseline to five years after surgery|Remission or improvement of Hypertension, Remission or improvement of Hypertension after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association. Complete remission: blood pressure (BP) <120/80 without medication Partial remission: systolic BP 120-140 mmHg and diastolic BP 80-89 mmHg without medication., From baseline to five years after surgery|Remission of improvement of Dyslipidemia, Remission or improvement of Dyslipidemia after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association. Low-density lipoprotein cholesterol (LDLc) < 100 mg/dl, Triglycerides (TG) < 150 mg/dl, total cholesterol < 200 mg/dl, High-density lipoprotein cholesterol (HDLc) > 60 mg/dl., From baseline to five years after surgery|Remission or improvement of Obstructive Sleep Apnea Syndrome, Remission or improvement of Obstructive Sleep Apnea Syndrome after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association. Number of apneic-hypopneic episodes/hour, recorded by polysomnography., From baseline to five years after surgery

Quality of life after surgery, Quality of life with the Bariatric Analysis and Reporting Outcome System (B.A.R.O.S) Scale. The score range is from 0 to 6 if the patient doesn´t have comorbidities. The result varies depending on the score. Failed=0, regular=0-1.5, good=1.5-3, very good=3-4.5, excellent=4.5-6. The score range is from 0 to 9 if the patient has some comorbidities. The result varies depending on the score. Failed=0-1, regular=1-3, good=3-5, very good=5-7, excellent=7-9. We will measure it a year and 5 years after surgery., From baseline to five years after surgery

Hospital Universitario de Fuenlabrada

Spanish Association of Surgeons (AEC)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

BPG-1

2019-01-29

2024-10-11

2026-09-21

2022-04-19

2023-10-17

Juan José Arroyo Martín, Denia, Alicante, 03700, Spain|Esther Mans Muntwyler, Mataró, Barcelona, 08301, Spain|Débora Acín Gándara, Fuenlabrada, Madrid, 28942, Spain

{ "Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb": [ { "intervention_type": "PROCEDURE" } ] }

NCT05559073

Outcomes of Early Referral to Radiofrequency Ablation in Symptomatic Atrial Fibrillation Patients.

https://clinicaltrials.gov/study/NCT05559073

NOT_YET_RECRUITING

Atrial fibrillation (AF) is the most common arrhythmia among adults with increasing risk of stroke, heart failure and mortality. The EAST-AFNET 4 trial showed that rhythm control treatment (Antiarrhythmic drugs AAD or catheter ablation) was associated with a lower risk of adverse cardiovascular outcomes than usual care among patients who had recently (within one year) been diagnosed with atrial fibrillation. In phase II/III GLORIA AF registry, Early AF ablation within 3 months from initial diagnosis in a contemporary cohort of patients who were predominantly treated with non-vitamin K antagonist oral anticoagulants was associated with a survival advantage compared to medical therapy alone. Moreover, early AF ablation appeared to provide the greatest benefit compared to other treatments. The ATTEST trial was a multicenter, randomized, prospective study in patients with paroxysmal atrial fibrillation (AF) designed to assess whether radiofrequency (RF) ablation is more effective in delaying the progression to persistent AF than AADs. Patients >_65 years were significantly more likely to progress to persistent AF/AT than patients were <65 years, suggesting that early RF ablation may be an effective treatment strategy for delaying AF progression. So, we hypothesize that early AF ablation within one year after first AF diagnosis may associate with improved procedures outcomes in symptomatic AF patients.

NO

Atrial Fibrillation|Radiofrequency Ablation

PROCEDURE: Radiofrequency ablation

Freedom from any atrial arrhythmia after single ablation procedure., freedom from any documented atrial arrhythmia lasted for more than 30 seconds., 12 months

Assiut University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

Early Referral to AF Ablation

2022-10-06

2023-06-30

2023-10-30

2022-09-29

2022-09-29

{ "Radiofrequency ablation": [ { "intervention_type": "PROCEDURE" } ] }