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NCT01286831

A Single Dose Study to Determine the Excretion, Balance and Metabolic Disposition of Radiolabelled GW642444.

https://clinicaltrials.gov/study/NCT01286831

COMPLETED

The purpose of this study is to characterise the metabolic disposition of radiolabelled GW642444 when administered orally.

NO

Pulmonary Disease, Chronic Obstructive

DRUG: [14C]GW642444

AUC(0-∞), AUC(0-t), Cmax, tmax, λz and t1/2 of total drug-related material (radioactivity) in plasma following oral dosing., Two months from first dose.|AUC(0-t), Cmax and tmax of GW642444 following oral dosing., Two months from first dose.|Urinary and faecal cumulative excretion as a percentage of the total radioactive dose administered over time., Two months from first dose.

Characterisation of metabolites in plasma, urine, duodenal bile and faecal homogenates., One year from last subject last visit|Vital signs, 12-lead ECG, Clinical laboratory tests, AEs., Two weeks from first dose.

GlaxoSmithKline

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

106181

2010-05-18

2010-07-09

2010-07-09

2011-01-31

2017-06-20

GSK Investigational Site, Zuidlaren, 9471 GP, Netherlands

{ "[14C]GW642444": [ { "intervention_type": "DRUG" } ] }

NCT02615431

The Influence of MitraClip on Apnoea Asleep

https://clinicaltrials.gov/study/NCT02615431

MiClAS

UNKNOWN

The aim of the present study is to influence the central and obstructive sleep apnoea in patients with severe mitral insufficiency by an interventional MitraClip examination to evaluate.

NO

Sleep Apnoea

OTHER: MitraClip Intervention

Apnoea-Hypopnoea-Index, 12 months

RWTH Aachen University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

15-060

2015-11

2016-11

2016-11

2015-11-26

2016-06-10

University Hospital RWTH Aachen, Department of Medical Clinic I, Aachen, 52074, Germany

{ "MitraClip Intervention": [ { "intervention_type": "OTHER" } ] }

NCT00617331

H9 Priming Study in Healthy Adults

https://clinicaltrials.gov/study/NCT00617331

COMPLETED

The purpose of this research study is to determine whether prior exposure to A/H2N2 viruses is associated with better antibody (part of the immune system that fights infection) responses after vaccination with an A/H9N2 flu vaccine. The study will evaluate how much antibody is made to the influenza virus after H9N2 flu vaccination and how the body reacts to different strengths of the H9N2 flu vaccine. This information may guide vaccine development for this virus as well as other bird flu viruses that have infected humans. Study participants will include 120 healthy subjects, age 18-38 or 44-59 years. Two different dosages of vaccine will be given in the muscle of the upper arm about 1 month apart. The assignment of vaccines to participants is governed by chance. Study procedures may include medical history, physical exam, and blood samples. Study participation duration is about 7 months.

NO

Influenza

BIOLOGICAL: Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine

Frequency of 4-fold or greater serum hemagglutination inhibition assay (HAI) and neutralizing antibody rises in both age groups to the homologous vaccine antigen., 28 Days after the first vaccine dose.

Frequencies of 4-fold or greater increase in titer between pre- and post-immunization samples., 28 days after the second vaccination (day 56).|Frequencies and severity of solicited and local and systemic adverse events in each vaccine dosage/age group., 7 days after each inoculation.|Proportion of subjects in each age/vaccine dosage group that achieves an HAI titer of at least 32., 28 days after each vaccination (Day 28, Day 56).|Frequencies and GMT of serum HAI and serum neutralizing antibody against a homologous A/H9N2 virus., One month after each vaccination (Day 28, Day 56).|Adverse event (AE) or serious adverse event (SAE) information (solicited in-clinic and via memory aids and periodic targeted physical assessment)., Duration of study.|Proportion of subjects in each group with serum HAI or neutralizing antibody to influenza A/H2N2 viruses and the frequency and magnitude of antibody responses., Before and after vaccination.|Geometric mean titer (GMT) of serum HAI and serum neutralizing antibody against the influenza A/H9N2 virus., One month after each vaccination (Day 28, Day 56).

National Institute of Allergy and Infectious Diseases (NIAID)

ALL

ADULT

PHASE2

NIH

INTERVENTIONAL

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

06-0073|N01AI30039C

2008-02

2008-08

2009-01

2008-02-18

2011-07-22

Baylor College of Medicine, Houston, Texas, 77030, United States

{ "Subvirion inactivated influenza A/H9N2 (G9 variant) vaccine": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT00115531

Eldery High Dose TIV 2005

https://clinicaltrials.gov/study/NCT00115531

COMPLETED

The purpose of this study is to compare a new higher-dose influenza virus vaccine to the standard dose vaccine in elderly adults who can walk. Current influenza vaccines protect elderly against viral influenza but not as well as desired. It is expected that the higher doses vaccine can be given with little reaction, but this needs to be tested. Up to 410 people ages 65 years and older will be recruited from the community and from existing volunteer populations. Participants will receive either the high or standard dose injected in the muscle, remain in the clinic for 20 minutes afterward, and maintain a daily memory aid for 7 days. The memory aid will be reviewed by telephone 8-12 days after the injection and return to the clinic or contacted by telephone 6 months after the injection.

NO

Influenza

BIOLOGICAL: Trivalent inactivated influenza vaccine|BIOLOGICAL: Trivalent inactivated influenza vaccine

National Institute of Allergy and Infectious Diseases (NIAID)

ALL

OLDER_ADULT

PHASE2

NIH

INTERVENTIONAL

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

04-100

2005-04

2005-11

2005-06-23

2014-12-19

University of Iowa - Vaccine Research & Education Unit, Iowa City, Iowa, 52242-2600, United States|University of Maryland Baltimore, Baltimore, Maryland, 21201, United States|Saint Louis University, St. Louis, Missouri, 63131, United States|Cincinnati Children s Hospital Medical Center, Cincinnati, Ohio, 45229-3039, United States|Baylor College of Medicine, Houston, Texas, 77030, United States

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

NCT04730531

Postoperative Pain Control Using Local Wound Infiltration in Adolescent Idiopathic Surgery

https://clinicaltrials.gov/study/NCT04730531

RECRUITING

Non-opioid methods of pain management following posterior spinal fusion (PSF) have become increasingly popular given the rise of opioid abuse and opioid-related deaths. Orthopedic surgery remains one of the highest prescribing subspecialties. Local wound infiltration is an effective method of acute pain management following surgical intervention and is the standard in some surgical subspecialties, however, no randomized control trials (RCT) exist in the pediatric spine literature. This would be the first (RCT) to assess the use of local would infiltration in postoperative pain control following PSF for adolescent idiopathic scoliosis patients (AIS). The primary aim of this study is to investigate the efficacy of local wound infiltration with anesthetic agents in reduction of postoperative pain scores and post-operative opioid use during hospital admission following fusion surgery in AIS patients. The proposed single-center, double-blind prospective randomized study will be conducted by recruiting patients meeting the inclusion criteria of age 10-26 years and diagnosis of AIS undergoing posterior fusion surgery. Study participants will be randomized into either a local injection of 0.25% bupivacaine with epinephrine or a placebo of equal volume injectable saline. Patient-reported outcomes will be collected at 1-, 6-, 12- and 24-months postoperatively.

NO

Postoperative Pain|Spinal Fusion

PROCEDURE: Local infiltration with 0.25% bupivacaine and epinephrine|PROCEDURE: Placebo of equal volume injectable saline

Visual Analog Scale (VAS) pain score, The average Visual Analog Scale pain score (on a scale of 0-100 mm) during the first 24 hours postoperatively will be computed from at most six values typically obtained every four to six hours following surgery. The higher the score, the higher the experienced pain of the individual., 24 hours post-operatively

Average use of morphine equivalents, The average use of morphine equivalents per kilogram during the first 24 hours postoperatively. Morphine equivalents per kilogram will be also be obtained by reviewing post-anesthesia care unit reports., 24 hours post-operatively|Scoliosis Patient Questionnaire - Version 30 (SRS-30), SRS-30 scores at 1-, 6-, and 12-months post-operatively. The Scoliosis Research Society (SRS-30) questionnaire is a 30-question patient reported instrument developed to evaluate health-related quality of life in patients with scoliosis. Scores from the SRS-30 are compiled into five domain scores: pain, function, self-image, mental health and satisfaction with management of scoliosis. Each domain score is reported on a scale form 1-5. The lower the score, the worse the outcome., 1-, 6-, and 12-months post-operatively

Boston Children s Hospital

ALL

CHILD

OTHER

INTERVENTIONAL

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

IRB-P00037508

2022-06-02

2023-12-01

2024-12-01

2021-01-29

2022-08-26

Boston Children s Hospital, Boston, Massachusetts, 02115, United States

{ "Bupivacaine": [ { "intervention_type": "PROCEDURE", "description": "Local infiltration with 0.25% bupivacaine and epinephrine", "name": "Bupivacaine", "synonyms": [ "Buvacaina", "Svedocain Sin Vasoconstr", "DL-Bupivacaine", "Marcaine", "Carbostesin", "Bupivacain-RPR", "Bupivacaine Carbonate", "Bupivacaina Braun", "Posimir", "Marcain", "1-Butyl-2',6'-pipecoloxylidide", "Bupivacain RPR", "Bupivacaina", "Bupivacaine Anhydrous", "Bupivacaine Hydrochloride", "Bupivacaine Monohydrochloride, Monohydrate", "1-Butyl-N-(2,6-dimethylphenyl)-2-piperidinecarboxamide", "dl-1-Butyl-2',6'-pipecoloxylidide", "Bupivacain Janapharm", "Bupivacaine", "(RS)-bupivacaine", "Dolanaest", "Bupivacainum", "Racemic bupivacaine", "(\u00b1)-bupivacaine", "Sensorcaine" ], "mesh_id": "D000779", "generic_names": [ "Bupivacaine" ], "drugbank_id": "DB00297", "wikipedia_url": "https://en.wikipedia.org/wiki/Bupivacaine" } ], "Epinephrine": [ { "intervention_type": "PROCEDURE", "description": "Local infiltration with 0.25% bupivacaine and 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" } ], "Placebo of equal volume injectable saline": [ { "intervention_type": "PROCEDURE" } ] }

NCT04098731

Evaluation of Respiratory Function in Fibromyalgia

https://clinicaltrials.gov/study/NCT04098731

COMPLETED

This study will evaluate respiratory function in people with fibromyalgia and whether or not breathing patterns in this patient group can be explained by stress, emotional or biomechanical variables. In addition, examine the relationship between physical ability and lactate values.

NO

Fibromyalgia|Respiratory Alkalosis and Metabolic Acidosis|Chronic Hyperventilation

Forced expiratory volume in percentage (FEV%), The forced expiratory volume in percentage will be determined by the ratio of the forced expiratory volume in one second (L/sec) and the forced vital capacity (L). A spirometer is used for these respiratory tests., Day 1|Partial pressure of carbon dioxide, An arterial (radial) blood gas test will be performed to measure the carbon dioxide partial pressure (kPa)., Day 1

Respiratory rate, Respiratory rate is the number of breaths a person take per minute (number per minute). Respiratory rate will be measured by using intensive care equipment. Electrodes will be placed under each clavicle and over the lower ribs on the left side. The equipment sense the distance between the electrodes i.e the movement of the chest wall. After five minutes of relaxing, respiratory rate is measured during one minute., Day 1

Uppsala University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

uppsala18

2018-06-28

2022-02-01

2022-02-01

2019-09-23

2022-03-21

Nyköping hospital, Nyköping, Sörmland, 61185, Sweden

{}

NCT00129831

Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)

https://clinicaltrials.gov/study/NCT00129831

COMPLETED

The purpose of this study is to determine the safety and tolerability of single doses of QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to moderate COPD.

NO

COPD

DRUG: QAB149

Safety variables (laboratory tests, ECG, adverse events)

Lung function tests|Pharmacokinetics

Novartis

ALL

ADULT, OLDER_ADULT

PHASE2

INDUSTRY

INTERVENTIONAL

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

CQAB149B2202

2004-09

2005-09

2005-09

2005-08-12

2011-10-25

Radiant Research, Encinitas, California, 92024, United States|Radiant Research, Boise, Idaho, 83704, United States

{ "QAB149": [ { "intervention_type": "DRUG" } ] }

NCT00439231

Lenalidomide in Previously Treated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

https://clinicaltrials.gov/study/NCT00439231

COMPLETED

This study will evaluate the safety and effectiveness of a new drug called lenalidomide (Revlimid) for treating patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) who relapsed after their initial treatment. Patients 21 years of age and older with CLL or SLL who have previously received standard treatment may be eligible for this study. Participants take lenalidomide capsules once a day for 21 days, followed by 21 days off the drug. This constitutes one treatment cycle. Treatment continues for four cycles as long as the medicine is tolerated. After four cycles, patients who respond completely continue treatment for another two cycles; patients who respond partially continue treatment for another four cycles; and patients who do not respond stop treatment but continue to be followed for safety. ...

YES

Chronic Lymphocytic Leukemia (CLL)|Small Lymphocytic Lymphoma

DRUG: Lenalidomide

To Establish the Overall Response Rate Measured at 24 Weeks After First Dose of Lenalidomide Using This Dosing Regimen, To establish the overall response rate based on peripheral blood measures (absolute neutrophil count, platelets, and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after first dose of lenalidomide using this dosing regimen, 24 weeks of lenalidomide therapy

Georg Aue, M.D.

National Heart, Lung, and Blood Institute (NHLBI)

ALL

ADULT, OLDER_ADULT

PHASE2

NIH

INTERVENTIONAL

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

070104|07-H-0104

2007-02

2010-09

2010-11

2007-02-23

2014-01-13

2014-01-13

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

{ "Lenalidomide": [ { "intervention_type": "DRUG", "description": "Lenalidomide", "name": "Lenalidomide", "synonyms": [ "Revimid", "CC-5013", "Lenalidomida", "CC5013", "Revlimid", "3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione", "IMiD3 Cpd", "2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H- isoindol-2-yl)-", "1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline", "CC 5013", "Lenalidomide" ], "medline_plus_id": "a608001", "generic_names": [ "Lenalidomide" ], "mesh_id": "D020533", "drugbank_id": "DB00480" } ] }

NCT01788631

A Phase II Trial of Regadenoson in Sickle Cell Anemia

https://clinicaltrials.gov/study/NCT01788631

COMPLETED

This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational drug called Regadenoson (or Lexiscan) to learn whether the drug works in treating a specific disease, in this case Sickle Cell Disease (SCD). Investigational means that the drug is being studied. It also means that the FDA has not yet approved the drug for your type of disease. SCD is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) than people without SCD. This different type of hemoglobin makes the red blood cells change into crescent shape under certain conditions. Sickle-shaped cells are a problem because they often get stuck in the blood vessels blocking the flow of blood, and cause inflammation and injury to important areas in the body. Regadenoson (trade name Lexiscan) is a drug that may prevent this inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast infusion during a heart stress test in people who are unable to exercise enough to put stress on their heart by making the heart beat faster. Regadenoson has been studied as a long infusion at this dose in adults, and no safety issues have been identified (ClinicalTrials.gov Identifier: NCT01085201). This is the first study to look at patient benefit with the long infusion of the drug. This drug has been used in laboratory experiments and information from those other research studies suggests that this drug may help to protect the body from damage caused by sickle-shaped cells in this research study. In this research study, the investigators are specifically looking to see if Regadenoson is an effective treatment for pain crises and acute chest syndrome in SCD.

YES

Sickle Cell Anemia

DRUG: Regadenoson|DRUG: Placebo

Number of Participants With a Reduction in Invariant Natural-Killer T-Cell (iNKT Cell) Activation by 70% or More, To determine if infusional Regadenoson reduced iNKT cell activation among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo by 70% or greater., Baseline-End of study infusion over 48 hours

Length of Hospital Stay, To determine if regadenoson reduces length of hospital stay among individuals admitted with SCA and pain or ACS compared to placebo, Hospital Presentation- Hospital Discharge, assessed up to 1 month|Number of Participants With an Improvement in Respiratory Symptoms, To determine if regadenoson improved respiratory symptoms among individuals with sickle cell anemia (SCA) and pain or acute chest syndrome (ACS) compared to placebo. Patients were classified as having an improvement in respiratory symptoms if they experienced any of the following outcomes:(1) respiratory rate decreased by 25% from baseline or normalized (≤20 bpm) or (2) degree of hypoxia (SpO2) on room air increased by 10% from baseline or normalized (≥92%) or (3) thoracic pain improved by 3 points from baseline on a 10-point visual analog scale., Baseline-End of study infusion over 48 hours|Opioid Use, To determine if regadenoson reduces opioid use among individuals with SCA and pain or ACS compared to placebo., Baseline-End of study infusion over 48 hours|Level of Inflammatory Markers (A2A), To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo., Baseline-End of study infusion over 48 hours|Level of Inflammatory Markers (IL-4), To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo., Baseline-End of study infusion over 48 hours|Level of Inflammatory Markers (IFN-gamma), To determine if regadenoson reduces levels of inflammatory markers among individuals with SCA and pain or ACS compared to placebo., Baseline-End of study infusion over 48 hours

Dana-Farber Cancer Institute

Brigham and Women s Hospital|Boston Children s Hospital|La Jolla Institute for Allergy & Immunology|National Heart, Lung, and Blood Institute (NHLBI)|Washington University School of Medicine|Children s Hospital Medical Center, Cincinnati|University of Illinois at Chicago|Medical College of Wisconsin|Duke University|Johns Hopkins University|Wayne State University|Baylor College of Medicine|UCSF Benioff Children s Hospital Oakland

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

13-005|1P50HL110790-01

2013-07

2016-11-10

2016-12-12

2013-02-11

2018-02-07

2018-02-07

Children s Hospital and Research Center at Oakland, Oakland, California, 94609, United States|University of Illinois at Chicago, Chicago, Illinois, 60612, United States|Johns Hopkins University, Baltimore, Maryland, 21205, United States|Boston Children s Hospital, Boston, Massachusetts, 02215, United States|Brigham and Women s Hospital, Boston, Massachusetts, 02215, United States|Dana-Farber Cancer Institute, Boston, Massachusetts, 02215, United States|Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, 48201, United States|Washington University in St. Louis, Saint Louis, Missouri, 63110, United States|Duke University, Durham, North Carolina, 27705, United States|Cincinnati Children s Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|Medical College of Wisconsin, Milwaukee, Wisconsin, 53226, United States

{ "Regadenoson": [ { "intervention_type": "DRUG", "description": "Regadenoson", "name": "Regadenoson", "synonyms": [ "Regadenoson", "Regadenoson anhydrous" ], "drugbank_id": "DB06213", "generic_names": [ "Regadenoson" ] } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT03851731

Evaluation of Intranasal Naltrexone and Naloxone

https://clinicaltrials.gov/study/NCT03851731

COMPLETED

This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.

NO

Opioid-use Disorder

DRUG: Naltrexone|DRUG: Naloxone|DRUG: Naltrexol

Pharmacokinetic parameter [maximum serum concentration - Cmax], The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration [Cmax], of naltrexone and naloxone when administered and in combination., 12 days|Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t], The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve [AUCO-t] of naltrexone and naloxone when administered and in combination., 12 days|Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf], The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity [AUCO-inf] of naltrexone and naloxone when administered and in combination., 12 days

Adverse Events, To assess and document any adverse events measures, 15 days|Vital Sign - Heart Rate, To assess and document heart rate before and after intranasal dosing, 12 days|Vital Sign - Blood pressure (diastolic), To assess and document blood pressure (diastolic) before and after intranasal dosing, 12 days|Vital Sign - Blood pressure (systolic), To assess and document blood pressure (systolic) before and after intranasal dosing, 12 days|Vital Sign - Respiration Rate, To assess and document respiration rate before and after intranasal dosing, 12 days|Electrocardiogram, Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval., 12 days

National Institute on Drug Abuse (NIDA)

ALL

ADULT

PHASE1

NIH

INTERVENTIONAL

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

Naltrexone-Ph1a-001

2015-10-05

2015-11-07

2015-11-07

2019-02-22

2020-09-14

{ "Naltrexone": [ { "intervention_type": "DRUG", "description": "Naltrexone", "name": "Naltrexone", "synonyms": [ "Naltrexona", "Nalorex", "Antaxone", "Celupan", "N-Cyclopropylmethylnoroxymorphone", "Naltrexon", "Nemexin", "EN1639A", "EN 1639A", "Trexan", "Naltrexonum", "N-Cyclopropylmethyl-14-hydroxydihydromorphinone", "ReVia", "EN-1639A", "Naltrexone Hydrochloride", "Naltrexone", "17-(Cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxymorphinan-6-one", "17-(Cyclopropylmethyl)-4,5\u03b1-epoxy-3,14-dihydroxymorphinan-6-one", "Vivitrol" ], "medline_plus_id": "a609007", "generic_names": [ "Naltrexone" ], "mesh_id": "D009292", "drugbank_id": "DB00704" } ], "Naloxone": [ { "intervention_type": "DRUG", "description": "Naloxone", "name": "Naloxone", "synonyms": [ "", "Naloxon Ratiopharm", "Kloxxado", "(\u2212)-naloxone", "MRZ-2593", "MRZ 2593", "Nalone", "Narcanti", "Naloxona", "Narcan", "Nalossone", "17-allyl-3,14-dihydroxy-4,5\u03b1-epoxymorphinan-6-one", "Naloxon-Ratiopharm", "1-N-Allyl-14-hydroxynordihydromorphinone", "Hydrobromide, Naloxone", "MRZ 2593Br", "Naloxone Abello", "MRZ 2593 Br", "Hydrochloride Dihydride, Naloxone", "Curamed, Naloxon", "Naloxon Curamed", "Naloxone Hydrobromide", "Naloxone, (5 beta,9 alpha,13 alpha,14 alpha)-Isomer", "Naloxonum", "Abello, Naloxone", "MRZ2593", "Nyxoid", "MRZ 2593-Br", "Evzio", "Naloxone Hydrochloride Dihydride", "Hydrochloride, Naloxone", "Naloxone", "Naloxone Hydrochloride", "Dihydride, Naloxone Hydrochloride", "Naloxone Hydrochloride, (5 beta,9 alpha,13 alpha,14 alpha)-Isomer" ], "medline_plus_id": "a616003", "generic_names": [ "Naloxone" ], "mesh_id": "D009292", "drugbank_id": "DB01183", "wikipedia_url": "https://en.wikipedia.org/wiki/Naloxone" } ], "Naltrexol": [ { "intervention_type": "DRUG" } ] }

NCT04705831

Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post COVID-19 Infection

https://clinicaltrials.gov/study/NCT04705831

UNKNOWN

Randomized, Double Blind, Placebo Controlled, Proof-of-Concept Study to Evaluate the Benefit of RUCONEST in Improving Neurological Symptoms in Post-SARS-CoV-2 Infection.

NO

Post-Viral Fatigue Syndrome|Post-Viral Disorder (Disorder)|Covid19

DRUG: Ruconest

Neuropsychological Measures (BRIEF-A), Behavior Rating Inventory of Executive Function- Adult (BRIEF-A), Week 0|Neuropsychological Measures (BRIEF-A), Behavior Rating Inventory of Executive Function- Adult (BRIEF-A), Week 9|Neuropsychological Measures (BRIEF-A), Behavior Rating Inventory of Executive Function- Adult (BRIEF-A), Week 17|Neuropsychological Measures (RBANS), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Week 0|Neuropsychological Measures (RBANS), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Week 9|Neuropsychological Measures (RBANS), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Week 17|Neuropsychological Measures (BDI II), Beck Depression Inventory II (BDI II), Week 0|Neuropsychological Measures (BDI II), Beck Depression Inventory II (BDI II), Week 9|Neuropsychological Measures (BDI II), Beck Depression Inventory II (BDI II), Week 17|Neuropsychological Measures (MoCA), Montreal Cognitive Assessment (MoCA), Week 0|Neuropsychological Measures (MoCA), Montreal Cognitive Assessment (MoCA), Week 9|Neuropsychological Measures (MoCA), Montreal Cognitive Assessment (MoCA), Week 17|Patient-Rate Questionnaires (FSS), Fatigue Severity Scale (FSS), Week 0|Patient-Rate Questionnaires (FSS), Fatigue Severity Scale (FSS), Week 5|Patient-Rate Questionnaires (FSS), Fatigue Severity Scale (FSS), Week 9|Patient-Rate Questionnaires (FSS), Fatigue Severity Scale (FSS), Week 14|Patient-Rate Questionnaires (FSS), Fatigue Severity Scale (FSS), Week 17|Patient-Rate Questionnaires (MIDAS), Migraine Disability Assessment (MIDAS), Week 0|Patient-Rate Questionnaires (MIDAS), Migraine Disability Assessment (MIDAS), Week 5|Patient-Rate Questionnaires (MIDAS), Migraine Disability Assessment (MIDAS), Week 9|Patient-Rate Questionnaires (MIDAS), Migraine Disability Assessment (MIDAS), Week 14|Patient-Rate Questionnaires (MIDAS), Migraine Disability Assessment (MIDAS), Week 17|Patient-Rate Questionnaires (HIT), Headache Impact Scale (HIT), Week 0|Patient-Rate Questionnaires (HIT), Headache Impact Scale (HIT), Week 5|Patient-Rate Questionnaires (HIT), Headache Impact Scale (HIT), Week 9|Patient-Rate Questionnaires (HIT), Headache Impact Scale (HIT), Week 14|Patient-Rate Questionnaires (HIT), Headache Impact Scale (HIT), Week 17|Patient-Rate Questionnaires (Activities), Activities of Daily Living Sliding Scale and Questionnaire, Week 0|Patient-Rate Questionnaires (Activities), Activities of Daily Living Sliding Scale and Questionnaire, Week 5|Patient-Rate Questionnaires (Activities), Activities of Daily Living Sliding Scale and Questionnaire, Week 9|Patient-Rate Questionnaires (Activities), Activities of Daily Living Sliding Scale and Questionnaire, Week 14|Patient-Rate Questionnaires (Activities), Activities of Daily Living Sliding Scale and Questionnaire, Week 17|Patient-Rate Questionnaires (SF), SF McGill Pain Questionnaire, Week 0|Patient-Rate Questionnaires (SF), SF McGill Pain Questionnaire, Week 5|Patient-Rate Questionnaires (SF), SF McGill Pain Questionnaire, Week 9|Patient-Rate Questionnaires (SF), SF McGill Pain Questionnaire, Week 14|Patient-Rate Questionnaires (SF), SF McGill Pain Questionnaire, Week 17|Patient-Rate Questionnaires (GSRS), Gastrointestinal Symptoms Rating Scale (GSRS), Week 0|Patient-Rate Questionnaires (GSRS), Gastrointestinal Symptoms Rating Scale (GSRS), Week 5|Patient-Rate Questionnaires (GSRS), Gastrointestinal Symptoms Rating Scale (GSRS), Week 9|Patient-Rate Questionnaires (GSRS), Gastrointestinal Symptoms Rating Scale (GSRS), Week 14|Patient-Rate Questionnaires (GSRS), Gastrointestinal Symptoms Rating Scale (GSRS), Week 17|Patient-Rate Questionnaires (SF-36), SF-36, Week 0|Patient-Rate Questionnaires (SF-36), SF-36, Week 5|Patient-Rate Questionnaires (SF-36), SF-36, Week 9|Patient-Rate Questionnaires (SF-36), SF-36, Week 14|Patient-Rate Questionnaires (SF-36), SF-36, Week 17|Neurological Exam (0), Complete neurological examination, Week 0|Neurological Exam (9), Complete neurological examination, Week 9|Neurological Exam (17), Complete neurological examination, Week 17|Immunological Biomarkers (Toll), Toll Like Receptor Function Assay, Week 1|Immunological Biomarkers (Toll), Toll Like Receptor Function Assay, Week 9|Immunological Biomarkers (Toll), Toll Like Receptor Function Assay, Week 17|Immunological Biomarkers (GAD), GAD-65, Week 1|Immunological Biomarkers (GAD), GAD-65, Week 9|Immunological Biomarkers (GAD), GAD-65, Week 17|Immunological Biomarkers (Com), Complement Panel (C4, C1-INH, C1-INH Function), Week 1|Immunological Biomarkers (Com), Complement Panel (C4, C1-INH, C1-INH Function), Week 9|Immunological Biomarkers (Com), Complement Panel (C4, C1-INH, C1-INH Function), Week 17|Immunological Biomarkers (Ig), Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM), Week 1|Immunological Biomarkers (Ig), Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM), Week 9|Immunological Biomarkers (Ig), Immunoglobulins-Quantitative (IgA, IgE, IgG, IgM), Week 17|Immunological Biomarkers (IgG), Immunoglobulins G, Subclasses (1-4), Week 1|Immunological Biomarkers (IgG), Immunoglobulins G, Subclasses (1-4), Week 9|Immunological Biomarkers (IgG), Immunoglobulins G, Subclasses (1-4), Week 17|Immunological Biomarkers (TH/TH), TH1/TH2 Cytokine Levels, Week 1|Immunological Biomarkers (TH/TH), TH1/TH2 Cytokine Levels, Week 9|Immunological Biomarkers (TH/TH), TH1/TH2 Cytokine Levels, Week 17

IMMUNOe Research Centers

ALL

ADULT, OLDER_ADULT

PHASE4

INDUSTRY

INTERVENTIONAL

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

IIS202001-Neuroimmune

2020-12-30

2022-01

2022-01

2021-01-12

2021-01-12

IMMUNOe Research Centers, Centennial, Colorado, 80112, United States

{ "C1-inhibitor": [ { "intervention_type": "DRUG", "description": "Ruconest", "name": "C1-inhibitor", "synonyms": [ "Cinryze", "Ruconest", "Berinert", "C1-inhibitor" ], "wikipedia_url": "https://en.wikipedia.org/wiki/C1-inhibitor", "generic_names": [] } ] }

NCT04912531

Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery

https://clinicaltrials.gov/study/NCT04912531

RECRUITING

Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of pain and anxiety around the time of surgery. The aim of this study is to evaluate the feasibility of a virtual reality and olfactory stimuli multimodal intervention in patients undergoing cardiothoracic surgery. In addition, the investigators will evaluate the preliminary effects of the VR/OS intervention on patient pain and anxiety before and after cardiothoracic surgery. Patients who meet study inclusion criteria and are undergoing cardiothoracic surgery may participate in this study. Patients have an equal being assigned to undergo the virtual reality and olfactory stimuli intervention or continue getting usual medical care with their doctor. If the patient is assigned to receive the virtual reality and olfactory stimuli intervention, the first therapy session will take place approximately two to four weeks before surgery. This will involve wearing a virtual reality headset and scented necklace for approximately 10 minutes. The second session will occur 90 minutes before the surgery. Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon. During the patient s in-hospital recovery at night, they will receive lavender scented therapy.

NO

Postoperative Pain|Anxiety Postoperative|Opioid Use

DEVICE: Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG|DEVICE: Essence Olfactory Necklace|DEVICE: Bedside Olfaction Device

Number of Patients who Consent to Study Participation, Of the patients the investigators approach for study participation, the investigators will document the number who consent to study participation., On the day of enrollment into the study|Number of Patients who Complete the Study, Only patients who are assigned to the intervention arm will be evaluated for this outcome. The investigators will determine the number of patients who complete the study by evaluating the number of patients who enroll in the study, complete all the virtual reality and olfactory stimuli therapy sessions, and complete all study surveys., Through study completion, an average of 8 weeks|Single Ease Question (SEQ), The SEQ is a 7 point rating scale used to evaluate how easy or difficult an individual finds it to use a device. A higher score indicates that the user found the device easy to use while a lower score indicates the user found the device difficult to use., After the first virtual reality and olfactory stimuli intervention at enrollment

Change in Pain Score (Visual Analogue Scale), It is a scale of 100mm. The patient marks the scale to indicate the intensity of their pain. The minimum value is 0, which indicates no pain and the maximum value is 10, which indicates the worst pain., Pre- and Post-Intervention (approximately 10 minutes)|Change in Anxiety Score (State Trait Anxiety Inventory), The STAI consists of two 20-item self-report inventories. It is a rapid but detailed assessment that distinguishes between basal, transitory emotion (part one inventory - state anxiety) and reactive or anxiety-provoking situations (part two inventory - trait anxiety). Scores range from 20 to 80 with higher scores indicating a greater level of anxiety., Pre- and Post-Intervention (approximately 10 minutes)|Opioid Administration, Amount of opioids administered per day, measured in milligram morphine equivalents (MME), approximately 4 days|Change in Quality of Life (The Functional Assessment of Cancer Therapy - General )(FACT-G), It is a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being. A higher score indicates a better quality of life., Pre- and Post-study (approximately 8 weeks)|Change in Sleep Quality (Pittsburgh Sleep Quality Index), It is a standardized, widely used self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. Some of the items include scores related to sleep latency, sleep duration, habitual sleep efficiency, sleeping medication, etc. A higher score indicates more acute sleep disturbances., Pre- and Post-study (approximately 8 weeks)|Change in Symptom Burden (Edmonton Symptom Assessment Scale), A questionnaire used to rate the intensity of nine common symptoms experienced by patients, including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being and shortness of breath. A higher score indicates a worse symptom burden., Pre- and Post- study (approximately 8 weeks)|Patient satisfaction with the VR/OS system., A patient interview with focus questions centered on patient satisfaction with the virtual reality and olfactory stimuli devices., Post-study (approximately 10 minutes)

Massachusetts General Hospital

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2021P000469

2022-10-01

2025-05-31

2025-06-30

2021-06-03

2023-05-31

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

{ "Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG": [ { "intervention_type": "DEVICE" } ], "Essence Olfactory Necklace": [ { "intervention_type": "DEVICE" } ], "Bedside Olfaction Device": [ { "intervention_type": "DEVICE" } ] }

NCT03435731

Dual Obstructive Sleep Apnea Therapy

https://clinicaltrials.gov/study/NCT03435731

DOT

UNKNOWN

Continuous positive airway pressure (CPAP) is considered the gold standard therapy for obstructive sleep apnea (OSA). However, CPAP users sometimes experience pressure-related discomfort. It is thought that lower CPAP pressure may increase comfort and lead to greater treatment adherence. Mandibular advancement splint (MAS) therapy has been shown to be the preferred OSA treatment option among patients. However, MAS therapy is only partially effective in some OSA patients, especially in severe cases. It is thought that a combination of MAS and PAP therapy may benefit patients in which MAS alone is only partially effective. Using MAS and PAP at the same time is called Dual Therapy . Dual Therapy may allow a lower CPAP pressure to be applied, which may increase patient comfort and therefore increase treatment adherence and overall effectiveness. This study will evaluate the effectiveness of 1 month of Dual Therapy in 30 OSA patients.

NO

Obstructive Sleep Apnea

COMBINATION_PRODUCT: Dual Therapy

Change in CPAP Pressure, Optimal CPAP Pressure determined by the Respiratory Therapist (cmH2O), Baseline (from previous treatment with CPAP) and 1 month after commencing Dual Therapy treatment.|Comfort, A subjective assessment of the Dual Therapy treatment, reported via a questionnaire., Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.|Treatment Adherence (hrs/night), Adherence measured in hours per night., The duration of Dual Therapy treatment (1 month).|Treatment Adherence (% nights), Adherence measured in percentage of nights of use., The duration of Dual Therapy treatment (1 month).

Daytime Sleepiness, Evaluation of OSA specific fatigue using Epworth Sleepiness Scale (ESS) questionnaire. ESS measures daytime sleepiness via 8 questions that ask about daytime sleepiness during common everyday conditions. The potential range of scores for any questions is from 0 to 3. Higher values represent worse outcomes. Their are no subscales for ESS. The answers to the questions are all summed up. Total score ranges between 0 and 24. A score above 10 indicates daytime sleepiness with higher scores indicating more sleepiness., Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.|Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10), FOSQ-10 measures functional status and difficulty in performing everyday activities via 10 questions. The range of scores for any question is from 1 to 4. There is also a 0 score option for participants who do not engage in a particular activity for other reasons, in which case the question will be excluded. There are 5 subscales that measure: general productivity, activity level, vigilance, social outcomes, and intimacy and sexual relationships. To obtain the total score, a mean-weighted item score is computed for those subscales with more than one item. To calculate a mean-weighted item score calculate the mean of the answered items with responses > 1 for each subscale. The total score is then derived by calculating the mean of the subscale scores and multiplying that mean by five. Total score ranges between 5 and 20. Higher scores indicate better functional status., Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.|Efficacy - Oxygen Desaturation Index, The number of times per hour of sleep that the blood s oxygen level drop below 97% oxygen saturation., Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.|Efficacy - Time below 90% Saturation, Percentage of time during sleep that the patient s blood oxygen levels fall below 90% saturation., Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.|Efficacy - Minimum Saturation, The lowest percentage saturation of the patient s blood oxygen levels during sleep., Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

University of British Columbia

Université de Montréal

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

H18-00175|FCRC1801

2018-03-08

2018-10

2018-12

2018-02-19

2018-05-02

University of British Columbia, Vancouver, British Columbia, V6T 1Z3, Canada|Université de Montréal, Montréal, Quebec, H3T 1J4, Canada

{ "Dual Therapy": [ { "intervention_type": "COMBINATION_PRODUCT" } ] }

NCT03199131

The Right Ventricle in Chronic Pressure Overload: Identifying Novel Molecular Targets for Functional Imaging

https://clinicaltrials.gov/study/NCT03199131

MVD

COMPLETED

Chronically elevated pulmonary pressures do not immediately result in right ventricular failure. During the initial period of exposure, the RV adapts to the increased afterload by altering its metabolism and morphology so as to meet the increased work requirement. Several, interconnected adaptive mechanisms have been proposed, including myocyte hypertrophy, a switch in the primary fuel used for ATP generation, increased angiogenesis, and decreased production of mitochondrial reactive oxygen species. While adaptation is initially successful in many cases, it is temporary, and after an uncertain period of time, the ventricle begins to fail. This transition from a compensated to decompensated state is difficult to predict clinically, and patients with different etiologies of CPOS progress to overt RV failure over significantly different time periods. This variability hinders the implementation of treatments that are tailored to a specific disease stage.

NO

Chronic Thromboembolic Pulmonary Hypertension

PROCEDURE: Right ventricular biopsies

relationship between the metabolic, morphologic and functional alterations in the right ventricle, to investigate the relationship between the metabolic, morphologic and functional alterations in the right ventricle before surgery,one and six months after surgery.

validation in human subjects of metabolic signaling pathway alterations found in animal model, analyse gene and protein expression during surgery

Centre Chirurgical Marie Lannelongue

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2015-A00149-40

2017-02-20

2017-11-20

2018-10-20

2017-06-26

2020-01-23

Centre Chirurgical Marie Lannelongue, Le Plessis-Robinson, 92350, France

{ "Right ventricular biopsies": [ { "intervention_type": "PROCEDURE" } ] }

NCT06296173

Open Lung Protective Extubation Following General Anesthesia

https://clinicaltrials.gov/study/NCT06296173

OLEXT-3

NOT_YET_RECRUITING

Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective open lung mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various open lung ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in open lung ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation. Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.

NO

Intra-abdominal Surgery|Anesthesia|Lung Injury|Ventilator-Induced Lung Injury|Atelectasis

OTHER: Protective open-lung extubation|OTHER: Conventional extubation

Average weekly patient recruitment rate, Achieve a weekly patient recruitment rate of 2 patients per week per center, Every week. At the end of the study (average 9 months) at the study level.|Protocol adherence rate, Assess adherence to a protocol during emergence from anesthesia, monitoring four criteria (proper positioning (dorsal decubitus or semi-sitting position), correct FiO2 (100% or 50%), appropriate ventilatory mode (manual or pressure support ventilation), and proper end-expiratory pressure (zero or preserved end-expiratory pressure), and noting deviations, with adherence defined as successful performance of all criteria during extubation., At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.|Postoperative pulmonary complications outcome completion rate, Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition., At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.

Accuracy of self-reported protocol adherence compared to directly observed protocol adherence, Following emergence from general anesthesia, treating anesthesiologists will complete the same four-point scoring sheet as the research assistant to self-report protocol adherence., At the end of the surgery|Postoperative pulmonary complications, Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition., At postoperative day 7|Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit, Obtained from the electronic medical record or the handwritten vital signs sheet. Calculated as %.h-1, At postoperative day 7 or hospital discharge (earliest of the two)|Quality of recovery, Evaluated using the QoR-15 questionnaire completed at the bedside., At postoperative day 1|Discharge disposition, Location to which patient is discharged (e.g., home, long term care facility, etc.) Assessed during telephone interview and using administrative data. We will, At postoperative day 30|Days alive and out of hospital, Assessed during telephone interview and using administrative data, At postoperative day 30|Health-related quality of life, Evaluated using the EQ-5D-5L questionnaire completed during a telephone interview, At postoperative day 90

Lowest oxygen saturation post-extubation in the operating room, Lowest SpO2 in the operating room during emergence, At operating room exit|Time in minutes with oxygen saturation < 85% post-extubation in the operating room, Time with SpO2 < 85% in the operating room during emergence, At operating room exit|Re-intubation rate in the operating room and in the post-anesthesia care unit, Re-intubation in the operating room during emergence or in the post-anesthesia care unit, At discharge from the post-anesthesia care unit

Centre hospitalier de l Université de Montréal (CHUM)

CHU de Quebec-Universite Laval|The Ottawa Hospital|University Health Network, Toronto|Canadian Institutes of Health Research (CIHR)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

MP-02-2024-12094

2024-09-01

2025-12-01

2026-04-01

2024-03-06

2024-03-06

The Ottawa Hospital, Ottawa, Ontario, K1H 8L6, Canada|Unity Health Network, Toronto, Ontario, M5B 1W8, Canada|Centre Hospitalier de l Université de Montréal (CHUM), Montréal, Quebec, H2X 0C1, Canada|CHU de Québec - Université Laval, Québec, G1V 4G2, Canada

{ "Protective open-lung extubation": [ { "intervention_type": "OTHER" } ], "Conventional extubation": [ { "intervention_type": "OTHER" } ] }

NCT02896673

Evaluation of the Diagnostic Performance of Electrical Impedance Tomography to Detect Situations at Risk of Lesions Induced by Conventional Mechanical Ventilation in ARDS

https://clinicaltrials.gov/study/NCT02896673

COMPLETED

Acute respiratory distress syndrome remains a serious condition, with a mortality rate of between 30 and 50%. The use of mechanical ventilation with small tidal volumes, and by limiting the plateau pressure in the respiratory tract below 30 cm H2O has been shown to reduce mortality by approximately 10%, probably by reducing pulmonary hyperinflation and pulmonary lesions induced by mechanical ventilation. It is therefore now established that the respirator settings influence patient prognosis. However, around 30% of patients with ARDS ventilated with these settings supposedly protective continue to present signs of pulmonary hyperinflation on tomodensitometry, suggesting an additional reduction in the tidal volume could be required in certain patients. Electrical impedance tomography (EIT) is a new imaging technique that gathers functional pulmonary information at bedside. This technique also allows a regional analysis, allowing the complexity of the spatial distribution of ARDS pulmonary lesions to be understood. The hypothesis is that EIT is a reliable method to detect at-risk situations of lesions induced by mechanical ventilation among patients with ARDS.

NO

Respiratory Distress Syndrome

PROCEDURE: ventilatory conditions and measures with scanner and EIT

mean values of optimal PEP obtained by EIT, Data acquisition will be carried out for 2 minutes and will start after 2 minutes of applying each ventilatory long time experience (A, B, C, E). mean values of optimal PEP will be compared between the 2 methods (scan and EIT)., after 2 minutes of applying each ventilatory experience|mean values of optimal TV obtained by EIT, Data acquisition will be carried out for 2 minutes and will start after 2 minutes of applying each ventilatory long time experience (A, B, C, E). mean values of optimal TV will be compared between the 2 methods (scan and EIT), after 2 minutes of applying each ventilatory experience|mean values of optimal PEP obtained by scan, Data acquisition will start after 4 minutes of applying each ventilatory long time experience (A, B, C, D). mean values of optimal PEP will be compared between the 2 methods (scan and EIT)., after 4 minutes of applying each ventilatory experience|mean values of optimal TV obtained by scan, Data acquisition will start after 4 minutes of applying each ventilatory long time experience (A, B, C, D). mean values of optimal TV will be compared between the 2 methods (scan and EIT)., after 4 minutes of applying each ventilatory experience

Hospices Civils de Lyon

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2010-642

2012-07-17

2015-01-21

2015-01-21

2016-09-12

2018-11-15

Hôpital de la Croix Rousse, Lyon, France

{ "ventilatory conditions and measures with scanner and EIT": [ { "intervention_type": "PROCEDURE" } ] }

NCT01168973

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy

https://clinicaltrials.gov/study/NCT01168973

COMPLETED

The purpose of the study is to compare the survival of participants who receive chemotherapy and ramucirumab versus chemotherapy alone as second line treatment for NSCLC after prior first line platinum-based chemotherapy.

YES

Non-Small Cell Lung Cancer

BIOLOGICAL: Ramucirumab|DRUG: Placebo (for Ramucirumab)|DRUG: Docetaxel

Overall Survival, Overall survival was the time from randomization until the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive., Randomization to date of death from any cause (up to 34 months)

Progression-Free Survival (PFS) Time, PFS time was the time from randomization until the date of objectively determined progressive disease (PD) or death due to any cause, whichever occurred first. According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD who were alive at the end of the follow-up period (or lost to follow-up) were censored on the date of the participant s last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization., Randomization to measured PD or date of death from any cause (up to 29 months)|Percentage of Participants Achieving an Objective Response (Objective Response Rate), Participants achieved an objective response if they had a best overall response of partial response (PR) or complete response (CR). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels [if tumor markers were initially above the upper limit of normal (ULN)]. The percentage of participants who achieved an objective response=(number of participants with CR or PR)/(number of participants assessed)*100., Baseline to measured PD (up to 29 months)|Percentage of Participants Achieving Disease Control (Disease Control Rate), Participants achieved disease control if they had a best overall response of PR, CR or stable disease (SD). According to RECIST v1.1, PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter; CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN). SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control=(number of participants with CR, PR, or SD)/(number of participants assessed)*100., Baseline to measured PD (up to 29 months)|Maximum Improvement on Lung Cancer Symptom Scale (LCSS), The LCSS consisted of 9 items: 6 items focused on lung cancer symptoms [loss of appetite, fatigue, cough, dyspnea (shortness of breath), hemoptysis (blood in sputum), and pain] and 3 items were global items (symptom distress, interference with activity level, and global quality of life). Participant responses to each item were measured using visual analogue scales (VAS) with 100-mm lines. A higher score for any item represented a higher level of symptoms/problems. The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom items of the LCSS, and the Total LCSS was the mean of all 9 LCSS items. ASBI and Total LCSS were not computed for a participant if he/she had 1 or more missing values for the 6 and 9 items, respectively. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable., Baseline, Day 21 of each cycle, and 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Change From Baseline to 30-Day Follow-Up Visit on European Quality of Life Questionnaire-5 Dimension (EQ-5D) Health State Scores, The EQ-5D is a quality-of-life instrument that consists of 2 parts. The first part (Health State Index score) allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension). The second part of the EQ-5D was a VAS that allowed participants to rate their present health condition. Possible EQ-5D VAS scores ranged from 0 (worst imaginable health state) to 100 (best imaginable health state)., Baseline, 30 days following last infusion (up to Cycle 38, 21 days/cycle)|Maximum and Minimum Serum Concentrations (Cmax and Cmin) of Ramucirumab, Prior to infusion and 1 hour following infusion for 4 and 8 (cycles 3 and 5 at 21 days/cycle)|Number of Participants With Anti-Ramucirumab Antibodies, The number of participants who had treatment-emergent or follow-up emergent anti-drug antibodies (ADA) is reported. Participants with treatment-emergent ADA were defined as participants who had any sample from baseline through Cycle 5 pre-infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer, or participants who tested negative at baseline and positive post-baseline (at titer of ≥1:20). Participants with follow-up emergent ADA were defined as participants who had any sample during 30 days post last infusion that was a 4-fold increase (2 dilution increase) in immunogenicity titer over the baseline titer., Baseline, prior to infusion for week 4 and 8 (cycles 3 and 5), and 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) or Died, Data presented are the number of participants who experienced at least 1 TEAE, Grade 3, 4, or 5 TEAE, treatment-emergent serious adverse event (SAE), TEAE leading to discontinuation of study treatment (ramucirumab/placebo or docetaxel), and TEAE leading to death. Clinically significant events were defined as treatment-emergent SAEs and other non-serious adverse events (AEs) regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module., First infusion up to 30 days following last infusion (up to Cycle 38, 21 days/cycle)

Eli Lilly and Company

ALL

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

13852|I4T-MC-JVBA|2010-021297-11|CP12-1027|CTRI/2011/08/001942

2010-12

2013-12

2016-08

2010-07-23

2014-12-29

2019-09-25

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Phoenix, Arizona, 85016, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sedona, Arizona, 86336, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fayetteville, Arkansas, 72703, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Alhambra, California, 91801, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Duarte, California, 91010, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fresno, California, 93720, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fullerton, California, 92835, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., La Jolla, California, 92093, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Long Beach, California, 90813, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Los Angeles, California, 90095, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Northridge, California, 91325, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Redondo Beach, California, 90277, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Santa Barbara, California, 93105, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Santa Monica, California, 93454, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Denver, Colorado, 80218, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Waterbury, Connecticut, 06708, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jacksonville, Florida, 32204, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Miami, Florida, 33176, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ocala, Florida, 34471, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Orlando, Florida, 32806, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Athens, Georgia, 30607, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Augusta, Georgia, 30901, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lawrenceville, Georgia, 30045, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Macon, Georgia, 31201, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rome, Georgia, 30165, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Savannah, Georgia, 31405, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Springfield, Illinois, 62703, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bloomington, Indiana, 47402, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cedar Rapids, Iowa, 52402, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Iowa City, Iowa, 52242, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Overland Park, Kansas, 66210, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wichita, Kansas, 67214, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ashland, Kentucky, 41101, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mount Sterling, Kentucky, 40353, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Baton Rouge, Louisiana, 70809, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Metairie, Louisiana, 70006, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bethesda, Maryland, 20817, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chevy Chase, Maryland, 20815, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Boston, Massachusetts, 02115, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Danvers, Massachusetts, 01923, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Framingham, Massachusetts, 01701, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Newton, Massachusetts, 02462, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ann Arbor, Michigan, 48109, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Minneapolis, Minnesota, 55404, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Columbia, Missouri, 65201, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Joplin, Missouri, 64804, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saint Louis, Missouri, 63110, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Billings, Montana, 59101, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Henderson, Nevada, 89169, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Reno, Nevada, 89502, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lebanon, New Hampshire, 03756, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Portsmouth, New Hampshire, 03801, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Albuquerque, New Mexico, 87109, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bronx, New York, 10467, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Latham, New York, 12110, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., New York, New York, 10021, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Durham, North Carolina, 27704, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Raleigh, North Carolina, 27607, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fargo, North Dakota, 58122, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Columbus, Ohio, 43219, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tulsa, Oklahoma, 74136, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Abington, Pennsylvania, 19001, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kingston, Pennsylvania, 18704, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Philadelphia, Pennsylvania, 19106, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Charleston, South Carolina, 29414, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sioux Falls, South Dakota, 57104, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chattanooga, Tennessee, 37403, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Memphis, Tennessee, 38138, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Abilene, Texas, 79606, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Amarillo, Texas, 79106, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Beaumont, Texas, 77702, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bedford, Texas, 76022, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dallas, Texas, 75231, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., El Paso, Texas, 79915, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fort Worth, Texas, 76104, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lewisville, Texas, 75067, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., McAllen, Texas, 78503, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mesquite, Texas, 75150, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Midland, Texas, 79701, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Odessa, Texas, 79761, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Paris, Texas, 75460, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Antonio, Texas, 78212, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Antonio, Texas, 78229, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sherman, Texas, 75090, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sugar Land, Texas, 77479, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., The Woodlands, Texas, 77380, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tyler, Texas, 75702, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Webster, Texas, 77598, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wichita Falls, Texas, 76310, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Christiansburg, Virginia, 24073, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fairfax, Virginia, 22031, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Newport News, Virginia, 23601, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Richmond, Virginia, 23298, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lacey, Washington, 98503, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Spokane, Washington, 99216, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wenatchee, Washington, 98801, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Madison, Wisconsin, 53705, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Buenos Aires, C1417EYG, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Córdoba, X5016KEH, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., La Rioja, 5300, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rosario, 2000, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tucumain, 4000, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Viedma, 8500, Argentina|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Graz, 8036, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Grimmenstein, 2840, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Vienna, A-1140, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wels, 4600, Austria|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Barretos, 14784700, Brazil|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Belo Horizonte, 31110580, Brazil|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Goiania, 74140050, Brazil|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Porto Alegre, 90430-090, Brazil|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., São Paulo, 1224010, Brazil|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Edmonton, Alberta, T6G 1Z2, Canada|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Moncton, New Brunswick, E1C 6Z8, Canada|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Sainte-Foy, Quebec, G1V 4G5, Canada|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Grenoble, 38049, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lille, 59037, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lyon, 69373, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nice, 06050, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Strasbourg, 67091, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Toulouse, 31059, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Vandoeuvre Les Nancy, 54511, France|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Augsburg, 86150, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bad Soden, 65812, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bielefeld, 33611, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dresden, 01307, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Frankfurt, 60596, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gerlingen, 70839, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Großhansdorf, 22927, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Halle, 06120, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Heidelberg, 69126, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Immenhausen, 34376, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Oldenburg, 26121, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ulm, 89081, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Villingen-Schwenningen, 78050, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Athens, 10676, Greece|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Chania, 73300, Greece|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kifissia, 14564, Greece|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Patras, 26500, Greece|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Budapest, 1145, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gyula, 5703, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Matrahaza, 3233, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Nyiregyhaza, 4412, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pécs, 7623, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Szekesfehervar, 8000, Hungary|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bangalore, 560099, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cuttack, 753007, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Delhi, 110085, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jaipur, 302017, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kochin, 628040, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Madurai, 625020, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mumbai, 400 012, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pune, 411001, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Trivandrum, 695 011, India|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Haifa, 31096, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Jerusalem, 91120, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kfar Saba, 44281, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Petah Tikva, 49100, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Safed, 13110, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tel-Aviv, 64239, Israel|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Livorno, 57124, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Monza, 20900, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Novara, 28100, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Padova, 35128, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Palermo, 90146, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Parma, 43100, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pisa, 56124, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Rome, 00152, Italy|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Incheon, 405-760, Korea, Republic of|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Seoul, 120-752, Korea, Republic of|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Suwon-City, 442-723, Korea, Republic of|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Guadalajara, 44280, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mexico City, 14000, Mexico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Amsterdam, 1091AC, Netherlands|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Arnhem, 6815 AD, Netherlands|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Harderwijk, 3844 DG, Netherlands|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., S-Hertogenbosch, 5223 GZ, Netherlands|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Zwolle, 80211 JW, Netherlands|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Grafton, 1023, New Zealand|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wellington, 6002, New Zealand|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Oslo, 0310, Norway|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Tromsø, 9012, Norway|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gdansk, 80-219, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Gdynia, 81-519, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Glucholazy, 48-340, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Krakow, 31-202, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lodz, 90-242, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Opole, 45-060, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Otwock, 05-400, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Poznan, 60-693, Poland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bayamon, 00959, Puerto Rico|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bucharest, 022328, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cluj-Napoca, 400058, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Iasi, 700106, Romania|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Moscow, 115478, Russian Federation|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saint Petersburg, 197758, Russian Federation|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Stavropol, 355047, Russian Federation|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Barcelona, 08003, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Girona, 17007, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Las Palmas De Gran Canaria, 35016, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Madrid, 28050, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mataró, 08304, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pamplona, 31008, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pozuelo De Alarcon, 28223, Spain|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Eskilstuna, 63188, Sweden|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Linkoping, 58185, Sweden|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lund, 22185, Sweden|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Solna, 17176, Sweden|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Basel, CH-4031, Switzerland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bern, CH-3010, Switzerland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Fribourg, 1708, Switzerland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Luzern, CH-6000, Switzerland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Zurich, CH-8091, Switzerland|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kaohsiung, 813, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kuei Shan Hsiang, 33305, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Neihu Taipei, 114, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Niao Sung Hsiang, 833, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Taichung, 40705, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Taipei, 11031, Taiwan|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ankara, 06500, Turkey|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Istanbul, 81540, Turkey|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Izmir, 35340, Turkey|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Kayseri, 38039, Turkey|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cottingham, East Yorkshire, HU16 5JQ, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., London, Greater London, W6 8RF, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Preston, Lancashire, PR2 9HT, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wythenshawe, Manchester, M23 9LT, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Scunthorpe, North Lincolnshire, DN15 7BH, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Glasgow, Scotland, G12 0YN, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Coventry, West Midlands, CV2 2DX, United Kingdom|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Wolverhampton, West Midlands, WV10 0QP, United Kingdom

{ "Ramucirumab": [ { "intervention_type": "BIOLOGICAL", "description": "Ramucirumab", "name": "Ramucirumab", "synonyms": [ "IMC 1121B", "1121B", "LY3009806", "IMC-1121B", "Cyramza", "Ramucirumab", "IMC1121B" ], "medline_plus_id": "a614026", "generic_names": [ "Ramucirumab" ], "mesh_id": "D020533", "drugbank_id": "DB05578", "wikipedia_url": "https://en.wikipedia.org/wiki/Ramucirumab" } ], "Placebo (for Ramucirumab)": [ { "intervention_type": "DRUG" } ], "Docetaxel": [ { "intervention_type": "DRUG", "description": "Docetaxel", "name": "Docetaxel", "synonyms": [ "Docetaxel Hydrate", "N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol", "Taxotere", "Docefrez", "Taxoltere Metro", "Docetaxol", "RP-56976", "RP56976", "Docetaxel anhydrous", "TXL", "Docetaxel Trihydrate", "N-Debenzoyl-N-(tert-butoxycarbonyl)-10-deacetylpaclitaxel", "Docetaxel", "RP 56976", "N-Debenzoyl-N-tert-butoxycarbonyl-10-deacetyltaxol", "N Debenzoyl N tert butoxycarbonyl 10 deacetyltaxol", "Docetaxel Anhydrous", "NSC 628503" ], "medline_plus_id": "a696031", "generic_names": [ "Docetaxel" ], "mesh_id": "D050257", "drugbank_id": "DB01248" } ] }

NCT00685373

Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease

https://clinicaltrials.gov/study/NCT00685373

COMPLETED

This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β [anti-IL-1β] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease. The duration of this study was 6 months with a maximum duration of 2 years

YES

Cryopyrin-Associated Periodic Syndromes|Familial Cold Autoinflammatory Syndrome|Muckle Wells Syndrome|Neonatal Onset Multisystem Inflammatory Disease

DRUG: Canakinumab (ACZ885)

The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions, The number of participants with Adverse Events and Infections & Infestations are regardless of study drug relationship by primary system organ class preferred term equal and/or greater than 2% in any group. The number of participants with mild injection site reactions= mild reactions observed on at least one occasion but no moderate or severe reactions. The number of participants with moderate injection site reactions= moderate reactions observed on at least one occasion but no severe reactions., 2 years depending on when the participant enters the study

The Percentage of Participants Without Disease Relapse as Determined by the Physician s Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers., Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician s Global Assessment of Autoinflammatory Disease Activity > minimal or Physician s Global Assessment >= minimal AND Skin Disease Assessment > minimal. Physician s Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe., Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Immunogenicity of Canakinumab (ACZ885), The number of participants who tested positive for anti-ACZ885 antibodies using the Biacore Assay at the end of the study., Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years|Pharmacokinetics, Mean Clearance from serum in Liter per Day (CLD) in adult participants >=18, pediatric participants <18 with body weight >40 kg and pediatric participants <18 with body weight <=40 kg., Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years

Novartis

ALL

CHILD, ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

CACZ885D2306

2008-05

2010-04

2010-04

2008-05-28

2011-05-27

2016-11-04

Little Rock Allergy and Asthma Clinic, Little Rock, Arkansas, 72205, United States|UCSF School of Medicine, San Francisco, California, 94118, United States|Allergy Center at Brookstone, Columbus, Georgia, 31904, United States|Rush-Presbyterian St. Lukes Medical Center, Chicago, Illinois, 60612, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|University of Wisconsin, Madison, Wisconsin, 53792, United States|Novartis Investigative Site, Laeken, Belgium|Novartis Investigative Site, Le Kremlin Bicetre, France|Novartis Investigative Site, Lille Cedex, France|Novartis Investigative Site, Montpelier Cedex, France|Novartis Investigative site, Nantes, France|Novartis Investigative site, Berlin, Germany|Novartis Investigative Site, Hamburg, Germany|Novartis Investigative site, Heidelburg, Germany|Novartis Investigative Site, Herne, Germany|Novartis Investigative Site, Marburg, Germany|Novartis Investigative site, Tubingen, Germany|Novartis Investigative site, New Delhi, India|Novartis Investigative site, Genova, Italy|Novartis Investigative Site, Napoli, Italy|Novartis Investigative Site, Padova, Italy|Novartis Investigative Site, Rome, Italy|Novartis Investigative Site, Trieste, Italy|Novartis Investigative Site, Madrid, Spain|Novartis Investigative site, Oviedo, Spain|Novartis Investigative Site, Vigo, Spain|Novartis Investigative site, Istanbul, Turkey|Novartis Investigative site, London, United Kingdom

{ "Canakinumab": [ { "intervention_type": "DRUG", "description": "Canakinumab (ACZ885)", "name": "Canakinumab", "synonyms": [ "Canakinumab", "Ilaris" ], "drugbank_id": "DB06168", "generic_names": [ "Canakinumab" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Canakinumab" } ] }

NCT00972673

A Study of GW685698X in Healthy Japanese Male Subjects

https://clinicaltrials.gov/study/NCT00972673

COMPLETED

This is a randomized, double blind, placebo controlled, parallel-group, repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose from a novel dry powder device in healthy Japanese male subjects.

NO

Asthma

DRUG: Placebo|DRUG: GW685698X

safety: adverse events, vital sign, ECGs, and clinical laboratory test|PK： Cmax, tmax and AUC(0-t)|PD: serum cortisol

GlaxoSmithKline

MALE

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

112018

2008-09-24

2008-12-19

2008-12-19

2009-09-07

2017-08-03

GSK Investigational Site, Kagoshima, 890-0081, Japan

{ "Placebo": [ { "intervention_type": "DRUG" } ], "GW685698X": [ { "intervention_type": "DRUG" } ] }

NCT03402373

Evaluation of the Nutritional Supplement Lycoderm on Its Impact on Skin Parameters

https://clinicaltrials.gov/study/NCT03402373

Lycoderm

COMPLETED

Carotenoids and polyphenols are assumed to have an active role in skin health. Sources for these phytonutrient are fruits and vegetables. They are widely applied as skin protectants, and supplementation with carotenoids have shown to protect against erythema caused by UV-radiation. UV radiation generates reactive oxygen species in the skin, which induces cellular signaling that may impair cell cycle, cell growth, and regeneration or repair processes.

NO

Skin Care

DIETARY_SUPPLEMENT: Lycoderm|DIETARY_SUPPLEMENT: Placebo

Improves skin hydration, instrumental evaluation (Corneometer), 16 weeks|Improves skin smoothness and texture, image analysis (Antera), 16 weeks|Improves lines and wrinkles, image analysis (Clarity), 16 weeks|Improves skin barrier function, instrumental evaluation (VapoMeter), 16 weeks|Improves skin thickness and density, instrumental evaluation (DermaScan Ultrasound), 16 weeks|Increases dermal hemoglobin, instrumental evaluation (SIAScope)., 16 weeks

LycoRed Ltd.

FEMALE

ADULT

INDUSTRY

INTERVENTIONAL

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

4158LY0817

2017-11-17

2019-03-17

2019-05-30

2018-01-18

2019-07-02

International Research Services, Inc., Port Chester, New York, 10573, United States

{ "Lycoderm": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ], "Placebo": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT04903873

A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors

https://clinicaltrials.gov/study/NCT04903873

RECRUITING

Phase 1 (Dose Escalation) of this study will assess the safety, tolerability, dose-limiting toxicity (DLT), and will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EU101 in participants with advanced solid tumors. Phase 2 (Dose Expansion) of the study will assess the antitumor effect of EU101 in two indications including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).

NO

Solid Tumor|Renal Cell Cancer Metastatic|Non-Small Cell Lung Cancer|Renal Cell Carcinoma|Prostate Cancer

DRUG: EU101

Phase 1: Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation, Baseline up to 30 months|Phase 1: Number of Participants With Dose Limiting Toxicity (DLT), At the end of Cycle 1 (Each cycle is of 21 Days)|Phase 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters, Laboratory assessments include hematology, serum chemistry, other blood tests, coagulation, and urine analysis. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in Vital Signs, Vital signs will include body temperature, pulse rate, and systolic and diastolic blood pressure measurements. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examination, Physical examination will include head, eyes, ears, nose and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 1: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG), ECG parameters included heart rhythm, pulse rate intervals, QRS, QT intervals, RR intervals and corrected QT(QTc) intervals. Number of participants with clinically significant abnormalities will be reported., Baseline up to 24 months|Phase 2: Objective Response Rate (ORR), Objective response rate (ORR), defined as the percentage of participants with a best overall response (BOR) of either a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors by investigators., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)

Phase 1: Objective Response Rate (ORR), Objective response rate (ORR), defined as the percentage of participants with a BOR of either a complete response (CR) or partial response (PR), per RECIST version 1.1 for solid tumors by investigators., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)|Phase 1 and 2: Duration of Response (DOR), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Disease Control Rate (DCR), DCR will be defined similarly to ORR but also including stable disease (SD) in the categorization of response (i.e, RECIST response of either CR, PR, or SD)., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Time to Response (TTR), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Time to Progression (TTP), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Durable Clinical Benefit (DCB), DCB will be defined similarly to DCR but additionally specifying that the disease control be achieved for at least 12 weeks consecutive (i.e, RECIST response of CR, PR or SD for greater than or equal to [>=] 12 weeks consecutive)., Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Progression-Free Survival (PFS), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Overall survival (OS), Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician s decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)|Phase 1 and 2: Maximum Observed Serum Concentration (Cmax) of EU101, Cmax is defined as maximum observed serum concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Trough Serum Concentration (Ctrough) of EU101, Ctrough is steady-state pre-dose concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of EU101, Tmax is defined as time to reach maximum observed serum concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of EU101, AUC0-24 is defined as the area under the serum concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24)., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of EU101, AUC0-last is defined as area under the serum concentration time-curve from time zero to the time of last measured concentration., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of EU101, AUCinf is defined as area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf)., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Elimination Half-Life Time (T1/2) of EU101, T1/2 is defined as plasma decay half-life is the time measured for the serum concentration to decrease by one half., Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)]|Phase 1 and 2: Apparent Volume of Distribution (Vd/F) of EU101, Vd/F is defined as volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug., Baseline (Day 1)|Phase 1 and 2: Apparent Oral Clearance of (CL/F) of EU101, Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes., Baseline (Day 1)|Phase 1 and 2: Mean Residence Time (MRT) of EU101, MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time., Baseline (Day 1)|Phase 1 and 2: Renal clearance (CLr) of EU101, CLr is defined as renal clearance is the volume of plasma completely cleared of EU101 by the kidneys per unit time., Baseline (Day 1)|Phase 1 and 2: Number of Participants with Positive Antidrug Antibodies (ADA), The immunogenic potential of EU101 will be assessed by summarizing the number of participants who develop detectable antidrug antibody (ADAs)., Baseline up to 56 months|Phase 2: Number of Participants With AEs and SAEs by Common Terminology Criteria for Adverse Events (CTCAE) v5.0, Time from first dose of study treatment up to 30 months

Eutilex

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

EU-CTS101-I-01

2021-05-31

2025-09

2025-12

2021-05-27

2024-03-15

Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111, United States|Mary Crowley Center, Dallas, Texas, 75230, United States|National Cancer Center, Ilsan, Korea, Republic of|Samsung Seoul Hospital, Seoul, Korea, Republic of|Seoul Asan, Seoul, Korea, Republic of|Severance Hospital, Seoul, Korea, Republic of

{ "EU101": [ { "intervention_type": "DRUG" } ] }

NCT05475873

Ondansetron for Postspinal Anesthesia Hypotension

https://clinicaltrials.gov/study/NCT05475873

COMPLETED

The purpose of this study is to investigate the effectiveness of ondansetron for postspinal anesthesia hypotension in patients undergoing cesarean section.

NO

Adverse Effect

DRUG: normal saline|DRUG: Ondansetron 4 mg|DRUG: Ondansetron 8 mg

Overall stability of systolic blood pressure control versus baseline, Evaluated by performance error (PE), 1-15 minutes after spinal anesthesia|The incidence of post-spinal anesthesia hypotension, Systolic blood pressure (SBP) < 80% of the baseline, 1-15 minutes after spinal anesthesia

Overall stability of heart rate control versus baseline, Evaluated by performance error (PE)., 1-15 minutes after spinal anesthesia|The incidence of severe post-spinal anesthesia hypotension, Systolic blood pressure (SBP) < 60% of the baseline, 1-15 minutes after spinal anesthesia|The incidence of nausea and vomiting., Presence of nausea and vomiting in patients after spinal anesthesia, 1-15 minutes after spinal anesthesia|The incidence of bradycardia., Heart rate < 55 beats/min., 1-15 minutes after spinal anesthesia|The incidence of hypertension, Systolic blood pressure (SBP) >120% of the baseline., 1-15 minutes after spinal anesthesia|pH, From umbilical arterial blood gases., Immediately after delivery|Partial pressure of oxygen, From umbilical arterial blood gases., Immediately after delivery|Base excess, From umbilical arterial blood gases., Immediately after delivery|APGAR score, A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration, 1 min after delivery|APGAR score, A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration, 5 min after delivery

General Hospital of Ningxia Medical University

FEMALE

ADULT

OTHER

INTERVENTIONAL

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

Yi Chen-2022-1

2023-06-18

2023-10-27

2023-10-27

2022-07-27

2023-11-02

General Hospital of Ningxia Medical University, Yinchuan, 750004, China

{ "normal saline": [ { "intervention_type": "DRUG" } ], "Ondansetron": [ { "intervention_type": "DRUG", "description": "Ondansetron 4 mg", "name": "Ondansetron", "synonyms": [ "4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-", "SN307", "Ondansetron", "ODT, Zofran", "SN-307", "Hydrochloride, Ondansetron", "Zofran ODT", "Ondansetron Monohydrochloride Dihydrate", "Ondansetron, (R)-Isomer", "Ondansetron Hydrochloride", "Zofran", "GR38032F", "Ondansetron Monohydrochloride", "GR 38032F", "Ondansetron, (+,-)-Isomer", "Zuplenz", "Monohydrochloride, Ondansetron", "Monohydrochloride Dihydrate, Ondansetron", "Dihydrate, Ondansetron Monohydrochloride", "SN 307", "GR-38032F", "Ondansetron, (S)-Isomer" ], "medline_plus_id": "a606022", "generic_names": [ "Ondansetron" ], "mesh_id": "D058831", "drugbank_id": "DB00904", "wikipedia_url": "https://en.wikipedia.org/wiki/Ondansetron" }, { "intervention_type": "DRUG", "description": "Ondansetron 8 mg", "name": "Ondansetron", "synonyms": [ "4H-Carbazol-4-one, 1,2,3,9-tetrahydro-9-methyl-3-((2-methyl-1H-imidazol-1-yl)methyl)-", "SN307", "Ondansetron", "ODT, Zofran", "SN-307", "Hydrochloride, Ondansetron", "Zofran ODT", "Ondansetron Monohydrochloride Dihydrate", "Ondansetron, (R)-Isomer", "Ondansetron Hydrochloride", "Zofran", "GR38032F", "Ondansetron Monohydrochloride", "GR 38032F", "Ondansetron, (+,-)-Isomer", "Zuplenz", "Monohydrochloride, Ondansetron", "Monohydrochloride Dihydrate, Ondansetron", "Dihydrate, Ondansetron Monohydrochloride", "SN 307", "GR-38032F", "Ondansetron, (S)-Isomer" ], "medline_plus_id": "a606022", "generic_names": [ "Ondansetron" ], "mesh_id": "D058831", "drugbank_id": "DB00904", "wikipedia_url": "https://en.wikipedia.org/wiki/Ondansetron" } ] }

NCT03243773

Evaluation of Lung Ultrasound in Acute Heart Failure

https://clinicaltrials.gov/study/NCT03243773

ELUSIA

COMPLETED

Acute heart failure is a life threatening condition requiring rapid diagnosis and treatment. However, the differentiation between heart failure and other conditions presenting with acute dyspnea is notoriously difficult in the emergency room. Point-of-care lung ultrasound is a simple, rapid and noninvasive technique directly visualizing fluid content in the lung as evidence for acute heart failure. A number of publications showed the diagnostic utility of lung ultrasound in the diagnosis of heart failure, but many open questions remain. The goal of this study is to evaluate the diagnostic accuracy of lung ultrasound to predict a cardiac origin of dyspnea in unselected patients in the emergency room as compared to standard evaluation. Further goals are to evaluate if lung ultrasound provides additional diagnostic information as compared to clinical examination, NT-proBNP and chest X-ray, to compare the diagnostic accuracy of lung ultrasound in different patient subgroups (heart failure with preserved vs reduced ejection fraction, de novo vs decompensated chronic heart failure, age ≥75 vs <75 years, women vs men and presence vs absence of concomitant pulmonary disease) and to compare demographics and clinical characteristics in different patient populations. 300 patients, aged ≥18 years presenting to the emergency room (ER) with acute dyspnoe as principal complaint will undergo initial clinical assessment of the likely etiology of dyspnea by the ER physician in charge. The second assessment by the same physician will include results of NT-proBNP according to predefined cutoffs. Final diagnosis ( Gold Standard ) will be done by two experienced investigators after patient discharge taking into account the complete medical record except the results of lung ultrasound. Assessment of chest X-ray and lung ultrasound by investigators will be preforemd blinded regarding all other results.

NO

Acute Heart Failure

OTHER: Lung ultrasound

Value of lung ultrasound in the diagnosis of acute heart failure, Presence/Absence of heart failure, at the time of inclusion into the study

Prof. Dr. Jörg Leuppi

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

BASEC 2015-00133

2016-03-01

2018-09-30

2018-09-30

2017-08-09

2019-09-19

Cantonal Hospital Baselland, Bruderholz, BL, 4101, Switzerland

{ "Lung ultrasound": [ { "intervention_type": "OTHER" } ] }

NCT05059873

Treatment Efficacy of Systemic Corticosteroids in AECOPD Patients With Higher Blood Eosinophil Levels

https://clinicaltrials.gov/study/NCT05059873

NOT_YET_RECRUITING

Chronic Obstructive Pulmonary Disease (COPD) is one of the top three causes of death worldwide now. Acute exacerbations (AEs) of COPD are a risk factor for lung function deterioration, poor quality of life, longer hospitalization, and increased mortality. To date, COPD is associated with a heavy clinical and socioeconomic burden, of which AEs of COPD account for a significant part of the cost of patients with COPD. Although several retrospective cohort studies and post-hoc analyses from randomized controlled trials (RCTs) showed that AECOPD patients with higher blood eosinophils had a shorter length of hospital stay (LOS), lower doses of corticosteroid use, and better response to systematic corticosteroid treatment than those with lower blood eosinophils, the efficacy of systematic corticosteroids in AECOPD patients with higher blood eosinophils has not been confirmed by RCTs. Therefore, this study aims to evaluate if AECOPD patients admitted to hospitals with higher blood eosinophil levels could benefit from systemic corticosteroid therapy. In this study, all eligible AECOPD participants with peripheral blood eosinophil blood count >2% or > 300 cells/μL will be randomly assigned (1:1) to either a control group or a systemic corticosteroid group. The control group will receive an oral placebo of 40mg/day for five consecutive days in addition to standard treatment during emergency admission or hospitalization. And systemic corticosteroid group will receive oral prednisone 40mg/day for five consecutive days and standard treatment. This study will provide evidence on using peripheral blood eosinophil blood count to guide corticosteroid therapy in AECOPD patients and help the clinician make an individual decision for each patient.

NO

Acute Exacerbation of COPD|Corticosteroid|Morality|Lung Diseases, Obstructive|Blood Eosinophil Count|COPD|Pulmonary Disease, Chronic Obstructive

DRUG: Prednisone|DRUG: Placebo

Treatment failure rates, Collect during index hospitalization and within 30 days after discharge. Treatment failure is defined as either one of events: a) requiring or receiving invasive or non-invasive MV during the index hospitalization; b) requiring or transferring to ICU during the index hospitalization; c) length of index hospitalization longer than 14 days; d) death during the index hospitalization or within 30 days after discharge; e) readmission with acute exacerbations of COPD within 30 days after discharge., 30 days

Requiring or receiving invasive or non-invasive MV during the index hospitalization, Collect during index hospitalization., 14 days|Requiring or transferring to ICU during the index hospitalization, Collect during index hospitalization., 14 days|Length of index hospitalization longer than 14 days, Collect during index hospitalization., 14 days|Death during the index hospitalization or within 30 days after discharge, Collect during index hospitalization and 30-day follow-up., 30 days after discahrge|Readmission with acute exacerbations of COPD within 30 days after discharge, Collect during index hospitalization and 30-day follow-up., 30 days after discahrge|All-cause mortality within 90 days after discharge, Collect during 90-day follow-up., 90 days after discahrge|Readmission rates of AECOPD at 60-day and 90-day follow-ups, Collect during 90-day follow-up., 90 days after discahrge|Time to readmission of AECOPD within 90 days after discharge, Collect during 90-day follow-up., 90 days after discharge|Severer infection or development of pneumonia during hospitalization, Collect during index hospitalization., 14 days|Changes in the scores of Hospital Anxiety and Depression Scale between index hospitalization and 90-day follow-up, Collect during 90-day follow-up. The minimum and maximum values are 14 and 70, respectively. Higher scores mean a worse outcome., 90 days|Changes in the scores of St. George s Respiratory Questionnaire between index hospitalization and 90-day follow-up, Collect during 90-day follow-up. The minimum and maximum values are 1 and 80, respectively. Higher scores mean a worse outcome., 90 days|Changes in the scores of exacerbations of chronic pulmonary disease tool between index hospitalization and 90-day follow-up, Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 14 and 73, respectively. Higher scores mean a worse outcome., 90 days|Changes in the scores of modified Medical Research Council Dyspnoea Scale between index hospitalization and 90-day follow-up, Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 1 and 5, respectively. Higher scores mean a worse outcome., 90 days|Changes in the scores of COPD Assessment Test between index hospitalization and 90-day follow-up, Collect during huopitalization and 90-day follow-up. The minimum and maximum values are 0 and 40, respectively. Higher scores mean a worse outcome., 90 days|Changes in the scores of Transition Dyspnea Index between index hospitalization and 90-day follow-up, Collect during huopitalization and 90-day follow-up., 90 days|Changes in the scores of COPD Exacerbation Recognition Tool during 90-day follow-up, Collect during 90-day follow-up by patients., 90 days after discharge|Length of hospital stay during hospitalization, Collect during huopitalization, 14 days

Capital Medical University

Peking University|Guang anmen Hospital of China Academy of Chinese Medical Sciences|Xuanwu Hospital, Beijing|Beijing Anzhen Hospital|Beijing Tongren Hospital|Beijing Luhe Hospital|Emergency General Hospital|Beijing Jishuitan Hospital|Beijing Jingmei Group Hospital|Beijing Shijingshan Hospital|Bejing INFI-SAGACITY TECHNOLOGY CO., LTD|Chinese People s Liberation Army of China General Hospital|Beijing Yanhua Hospital

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

Z201100005520029

2023-03-05

2024-01-31

2024-03-31

2021-09-28

2023-03-13

{ "Prednisone": [ { "intervention_type": "DRUG", "description": "Prednisone", "name": "Prednisone", "synonyms": [ "Apo-Prednisone", "Sone", "Acsis, Prednison", "Prednison Acsis", "Ultracorten", "Prednisona", "Kortancyl", "Cortan", "Encortone", "Prednisone Intensol", "Predni Tablinen", "17,21-Dihydroxypregna-1,4-diene-3,11,20-trione", "Sterapred", "Panafcort", "Predniment", "Cutason", "Deltasone", "1,4-Pregnadiene-17\u03b1,21-diol-3,11,20-trione", "Prednison Hexal", "Prednidib", "Encorton", "1,2-Dehydrocortisone", "Dehydrocortisone", "Liquid Pred", "delta-Cortisone", "Prednisonum", "Enkortolon", "Dacortin", "Decortisyl", "Meticorten", "Panasol", "Cortancyl", "Prednison Galen", "Rectodelt", "Orasone", "Decortin", "Pronisone", "Rayos", "Winpred", "Prednisone", "delta1-Cortisone-21-acetate", "Cortancyl", "Prednisone-21-acetate", "Prednisone 21-acetate", "Prednisone acetate", "21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione", "1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate", "delta'-Dehydrocortisone acetate", "delta1-Cortisone-21-acetate", "Cortancyl", "Prednisone-21-acetate", "Prednisone 21-acetate", "Prednisone acetate", "21-Acetoxy-17alpha-hydroxypregna-1,4-diene-3,11,20-trione", "1,4-Pregnadien-17\u03b1,21-diol-3,11,20-trione-21-acetate", "delta'-Dehydrocortisone acetate" ], "medline_plus_id": "a601102", "generic_names": [ "Prednisone", "Prednisone acetate", "Prednisone acetate" ], "mesh_id": "D018931", "drugbank_id": "DB00635" } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT04144673

A Study Investigating the Safety and Efficacy of Bio-Active Silver Hydrosol™ in Providing Immune Support

https://clinicaltrials.gov/study/NCT04144673

COMPLETED

The objective of this study is to investigate the ability of Bio-Active Silver Hydrosol™ in providing immune support in healthy adult males and females participating in intense aerobic exercise. Sixty eligible participants are planned to be randomized into either the investigational product or treatments arms and will consume the study product for 60 days (check-in visit on day 28). Questionnaires will be completed and blood and saliva samples will be collected to measure the endpoints.

NO

Healthy

OTHER: Silver Hydrosol|OTHER: Placebo

The difference between Bio-Active Silver Hydrosol™ and placebo in the mean global severity index, as measured by area under the curve (AUC) for the WURSS-24 daily symptom scores after 60 days supplementation., The Wisconsin Upper Respiratory Symptom Survey (WURSS) is a questionnaire used to evaluate the negative impact of acute URTIs. The WURSS-24 contains 24 items scored on a Likert-type severity scale. It contains the same items as the WURSS-21 along with headache, body ache, and fever to capture influenza-like illness symptoms. The items are scored on a 0 (do not have this symptom) to 7 (severe) scale., 60 days

Natural Immunogenics Corp.

KGK Science Inc.

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

19SIHN

2019-11-14

2020-06-01

2020-06-01

2019-10-30

2021-04-23

KGK Science Inc., London, Ontario, N6A 5R8, Canada

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

NCT00492973

Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?

https://clinicaltrials.gov/study/NCT00492973

COMPLETED

Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.

YES

Osteoarthritis|Post-traumatic; Arthrosis

DRUG: methylprednisolone acetate|DRUG: active comparator

Length of Hospital Stay, days after surgery|Knee Range of Motion, 3 months|Knee Society Scores, The Knee Society Score is on a scale of 0 to 100, with 0 being the worst possible score, and 100 being the best possible score. The Knee Society Score takes into account subjective patient reports of pain and functional ability as well as clinical measures of passive knee range of motion., 3 months postoperative|Amount of Pain Medication Taken Per Day, Average of 3 days after surgery|Patient Satisfaction, 6 weeks, 3 months, and 1 year postoperative|Complications, Such as Infections, Hospital Readmissions, Manipulations Under Anesthesia, Etc., any point during the first postoperative year

New Lexington Clinic

St. Joseph s Health Care London

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

LCO.2006.2

2006-03

2008-02

2008-02

2007-06-27

2013-12-19

2013-12-19

Lexington Clinic Sports Medicine Center, Lexington, Kentucky, 40504, United States

{ "Methylprednisolone": [ { "intervention_type": "DRUG", "description": "methylprednisolone acetate", "name": "Methylprednisolone", "synonyms": [ "Urbason", "Solu-Medrol", "A-Methapred", "Methylprednisolonum", "Metipred", "6\u03b1-methyl-11\u03b2,17\u03b1,21-triol-1,4-pregnadiene-3,20-dione", "Methylprednisolon", "Metilprednisolona", "Methylprednisolone", "Depo-Medrol (as acetate)", "1-dehydro-6\u03b1-methylhydrocortisone", "delta(1)-6alpha-Methylhydrocortisone", "(6\u03b1,11\u03b2)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione", "Solu-Medrol (as succinate)", "6-Methylprednisolone", "6 Methylprednisolone", "Medrol" ], "medline_plus_id": "a601157", "generic_names": [ "Methylprednisolone" ], "mesh_id": "D018696", "drugbank_id": "DB00959", "wikipedia_url": "https://en.wikipedia.org/wiki/Methylprednisolone" } ], "active comparator": [ { "intervention_type": "DRUG" } ] }

NCT02948673

The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise

https://clinicaltrials.gov/study/NCT02948673

DIMITOS

COMPLETED

Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise. Oxidative stress is suggested as a possible causative factor in the pathophysiology of skeletal muscle insulin resistance. GSH is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance. It has been found that patients with T2D have a decreased level of GSH in plasma and that 1 h GSH infusion improves skeletal muscle glucose uptake by ~25% and the redox environment in patients with T2D. Therefore, we want to investigate the effect of 3 months of GSH supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in patients with T2D and healthy controls. Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in the skeletal muscle. In contrast to the link between oxidative stress and insulin resistance, ROS produced in response to exercise is an important physiological stimulus as it is suggested to play a key role in the beneficial mitochondrial biogenesis observed in response to training. It has been reported that some patients with T2D have a diminished mitochondrial biogenesis in response to training, but the reason for this defect is not known. We want to investigate the link between exercise-stimulated ROS production and the mitochondrial biogenesis response in patients with T2D and healthy controls in response to acute exercise at two different intensities. Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic ROS level), we speculate that a lower exercise intensity, leading to a lower exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for mitochondrial biogenesis in patients with T2D.

NO

Type 2 Diabetes|Oxidative Stress|Mitochondrial Reactive Oxygen Species Production

DIETARY_SUPPLEMENT: Glutathione|OTHER: Placebo

Insulin sensitivity, Difference in insulin sensitivity (measured as glucose infusion rate during a hyperinsulinaemic euglycaemic clamp) between patients with type 2 diabetes receiving glutathione supplementation and patients with type 2 diabetes receiving placebo., 12 weeks

Mitochondrial reactive oxygen species production, Difference in the mitochondrial reactive oxygen species production between patients with type 2 diabetes receiving glutathione supplementation and patients with type 2 diabetes receiving placebo., 12 weeks

University of Copenhagen

MALE

ADULT

OTHER

INTERVENTIONAL

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

DIMITOS

2016-05

2017-12

2017-12

2016-10-28

2018-05-02

Xlab, Department of Biomedical Sciences, Faculty Of Health Sciences, University of Copenhagen, Copenhagen, Nørrebro, 2200, Denmark

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

NCT00651573

Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

https://clinicaltrials.gov/study/NCT00651573

COMPLETED

The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery. The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.

YES

Anemia

PROCEDURE: Blood transfusion at hematocrit value less than 24%|PROCEDURE: Blood transfusion at hematocrit value less than 28%

A Composite of In-hospital Postoperative Morbidity and Mortality, The composite components were in-hospital mortality, neurologic morbidity (stroke or coma), pulmonary morbidity (pneumonia, pulmonary embolus, or prolonged postoperative ventilation [>24 hours]), renal morbidity (renal failure), infectious morbidity (deep sternal wound infection, septicemia, or sepsis), cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, fibrillation, or asystole), gastrointestinal morbidity, reoperation (for bleeding, tamponade, graft occlusion, valve dysfunction, or noncardiac reasons), and vascular morbidity (aortic or femoral artery dissection or acute limb ischemia)., After surgery until hosptal discharge

Length of ICU Stays, After surgery until discharged from ICU|Length of Hospital Stay, After surgery until hospital discharge|Number of Blood Transfusion, From induction to the end of sugery|Prolonged Postoperative Ventilation, On ventilation >24 hours after surgery, After surgeyr until hospital discharge|Postoperative Atrial Fibrillation, After surgery until hospital discharge

The Cleveland Clinic

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

08-064

2007-03

2014-08

2019-01-03

2008-04-03

2019-06-14

2019-06-14

Cleveland Clinic, Cleveland, Ohio, 44195, United States|S.A.L. Hospital and Medical Institute, Ahmedabad, Thaltej,, 380054, India

{ "Blood transfusion at hematocrit value less than 24%": [ { "intervention_type": "PROCEDURE" } ], "Blood transfusion at hematocrit value less than 28%": [ { "intervention_type": "PROCEDURE" } ] }

NCT04235673

Oral Melatonin as Neuroprotectant in Preterm Infants

https://clinicaltrials.gov/study/NCT04235673

COMPLETED

Preterm newborns survival rates are improved, but long-term disabilities are still common. Major destructive focal lesions became less common, the most predominant lesion at present is diffuse white matter (WM damage). Melatonin (ME) serves as a neuroprotectant cerebral ischemia through its potent anti-oxidant/-inflammatory effect. Preclinical studies demonstrated that protects the developing brain by preventing abnormal myelination and inflammatory glial reaction. Clinical studies demonstrated ME ability in reducing brain damage after neonatal Hypoxic Ischemic Encephalopathy (HIE) or preventing neonatal impairments due to antenatal/ post-natal injuries: preeclampsia, IntraUterineGrowthRestriction (IUGR), ventilation, Bronchopulmonary Dysplasia (BPD). ME has a good safety profile with no known adverse effects. This study aims to highlight that ME can prevent brain impairment due to premature birth. ME will be administered orally (3 mg/kg/die for 15 days to neonates born before 29+6 week gestation, in a prospective double blind, randomized vs placebo study, 2 parallel arms. ME and malondialdehyde (MDA), a lipid peroxidation product) levels before and at the end of treatment will be measured . Other outcomes: Cerebral ultrasounds (cUS); cerebral magnetic resonance imaging (cMRI), Fagan test eye tracking, ophthalmological, auditory, neurological/cognitive child assessments. Monitoring parental distress, which can influence the neurodevelopmental outcome in preterms.

NO

Malondialdehyde|Melatonin

DIETARY_SUPPLEMENT: melatonin|DRUG: placebo

Malondialdehyde, plasmatic concentration pg/ml, 15 days|Melatonin, plasmatic concentration pg/ml, 15 days

Cranial ultrasound (cUS) Assessment, to identify and score White Matter injuries, up to 40 weeks|Brain Magnetic Resonance Immaging (cMRI) Assessment, Identify and score White Matter injuries, up to 40 weeks|Auditory brain stem evoked response (ABR) Assessments, Identify and score auditory diseases, up to 40 weeks

Fagan Test of Infant Intelligence (FTII), Measure the time ( minutes) to recognize unfamiliar versus familiar human faces to gauge visual-spatial encoding, attention, and working memory in infants., up to 24 months|Griffiths Mental Developmental Scales Revised (GMDS-R), The scales rate infant development across 5 main areas (locomotor, personal and social skills, hearing and language, eye and hand co-ordination, and performance), providing a general developmental quotient (DQ) of infants abilities and 5 subscale quotients (SQ)., up to 24 months|Child Behavior Checklist (CBCL) scales., A self-rating scale to evaluate emotional, social, and behavioral problems in infants, according to the parents evaluation., up to 24 months

Francesca Garofoli

IRCCS National Neurological Institute C. Mondino Foundation|Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

ALL

CHILD

OTHER

INTERVENTIONAL

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

20180004210 17/01/2018

2020-05-25

2022-10-01

2022-10-11

2020-01-22

2022-10-12

Child and Adolescence Neuropsychiatry Unit, Children s Hospital Spedali Civili of Brescia, 25123 Brescia, Italy., Brescia, BS, 25123, Italy|Neonatal Intensive Care Unit, Children s Hospital, University Hospital Spedali Civili Brescia, 25123 Brescia, Italy., Brescia, BS, 25123, Italy|Fondazione IRCCS Mondino, Pavia, PV, 27100, Italy|Neonatal Unit and NICU, Radiology, Clinical Chemistry Lab., Fondazione IRCCS Policlinico S. Matteo., Pavia, PV, 27100, Italy

{ "Melatonin": [ { "intervention_type": "DIETARY_SUPPLEMENT", "description": "melatonin", "name": "Melatonin", "synonyms": [ "5-methoxy-N-acetyltryptamine", "Slenyto", "M\u00e9latonine", "N-Acetyl-5-methoxytryptamine", "Adaflex", "Melatonina", "Circadin", "Melatonin", "Ceyesto", "N-[2-(5-methoxyindol-3-yl)ethyl]acetamide", "Syncrodin" ], "nhs_url": "https://www.nhs.uk/medicines/melatonin", "generic_names": [ "Melatonin" ], "drugbank_id": "DB01065", "wikipedia_url": "https://en.wikipedia.org/wiki/Melatonin" } ], "placebo": [ { "intervention_type": "DRUG" } ] }

NCT01950273

Pharmacokinetics and Pharmacodynamics of BI 695500 vs. Rituximab as First Line-treatment in Patients With Low Tumor Burden Follicular Lymphoma

https://clinicaltrials.gov/study/NCT01950273

COMPLETED

The primary objective of the study is to assess the pharmacokinetic (PK) similarity of Boehringer Ingelheim (BI) 695500 vs. rituximab (MabThera®) in previously untreated patients with low tumor burden follicular lymphoma (LTBFL). The secondary objective of the study is to evaluate the pharmacodynamics (PD), safety, and anti-tumor activity of BI 695500 vs. rituximab (MabThera®), as well as the presence of anti-drug antibodies (ADAs).

YES

Lymphoma, Follicular

DRUG: BI 695500|DRUG: MabThera

Area Under the Concentration (AUC) Time Curve of BI 695500 and Rituximab (MabThera®) Over the First Dosing Interval (Pre-infusion on Day 1 to Pre-infusion on Day 8), This outcome measure presents area under the concentration time curve of BI 695500 and Rituximab (MabThera®) over the first dosing interval (pre-infusion on Day 1 to pre-infusion on Day 8) (AUCDay 1-Day 8) for assessment of PK (Pharmacokinetics) similarity., Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 1, and at 24, 48, 72, 96 and 168 hours from start of infusion 1.

AUC of BI 695500 and Rituximab (MabThera®) Over the Fourth Dosing Interval (Pre-infusion on Day 22 to Day 29) (AUC Day 22-Day 29), This outcome measure presents area under the concentration of BI 695500 and Rituximab (MabThera®) over the fourth dosing interval (pre-infusion on Day 22 to Day 29)., Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 4, and at 24, 48, 72, 96 and 168 hours from start of infusion 4.|Maximum Measured Concentration of BI 695500 and Rituximab (MabThera®) in Plasma (Cmax) Following Dose 1, This outcome measure presents maximum measured concentration of BI 695500 and Rituximab (MabThera®) in plasma (Cmax) following Dose 1, Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 1, and at 24, 48, 72, 96 and 168 hours from start of infusion 1.|Maximum Measured Concentration of Rituximab (MabThera®) and BI 695500 in Plasma (Cmax) Following Dose 4, This outcome measure presents maximum measured concentration of Rituximab (MabThera®) and BI 695500 in plasma (Cmax) following Dose 4., Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion 4, and at 24, 48, 72, 96, 168, 336, 672, 1344, 2016 and 2880 hours from start of infusion 4.|Area Under the Depletion-time Curve of the Cluster of Differentiation (CD)19+ B-cell Count (% Change From Baseline (CFB)) in Peripheral Blood From Pre-infusion on Day 1 Until Last Measurement on Day 8 (Pre-infusion), This outcome measure presents area under the depletion-time curve of the CD19+ B-cell count (% change from baseline) in peripheral blood from pre-infusion on Day 1 until last measurement on Day 8 (pre-infusion) (AUC Day 1-Day 8, CD19+)., Blood samplings were done at pre-infusion and at end of infusion at 1, 2, and 4 hours from end of infusion, and at 24, 48, 72, 96 and 168 hours from start of infusion.|Change From Baseline (%) of CD19+ B-cells in Peripheral Blood Measured After Seven Days on Day 8 (Day 8 Pre-infusion Time Point), This outcome measure presents percent change from baseline of CD19+ B-cells in peripheral blood, measured after 7 days (i.e., Day 8 pre-infusion time point) (PCFBpre,2 CD19+)., Blood sampling was done at 168 hours from start of infusion.|Overall Response Rate (ORR) (Complete Response (CR) Plus Partial Response (PR)) Evaluated Approximately One Month After Last Dose of BI 695500 or Rituximab (MabThera®), Overall Response Rate (ORR) comprised Complete Response (CR) plus Partial Response (PR) evaluated approximately one month after last dose of BI 695500 or Rituximab [MabThera®]. Overall Response as defined by the revised International Working Group (IWG) Criteria 2007, using the Investigator s assessment., at Day 50.|Percentage of Patients With Treatment Emergent Adverse Events (TEAEs) Selected for Comparability Assessment of BI 695500 and Rituximab (MabThera®), This outcome measure presents percentage of patients with Treatment Emergent Adverse Events (TEAEs) selected for comparability assessment of BI 695500 and Rituximab (MabThera®)., Adverse Events (AEs) that started or worsened on or after the first dose of study medication and prior to the last date of study medication + 4 months (120 days) inclusive.

Boehringer Ingelheim

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

1301.5|2013-001904-12

2013-09-27

2015-12-22

2015-12-22

2013-09-25

2018-09-05

2018-09-05

The Canberra Hospital, Canberra, Migration Data, 2605, Australia|AKH - Medical University of Vienna, Wien, 1090, Austria|Brussels - UNIV St-Luc, Bruxelles, 1200, Belgium|UZ Leuven, Leuven, 3000, Belgium|Namur - HOSP Ste-Elisabeth, Namur, 5000, Belgium|Clinical Hospital Centre Zagreb, Zagreb, 10000, Croatia|University Hospital Brno, Brno, 625 00, Czechia|University Hospital Ostrava, Ostrava-Poruba, 70852, Czechia|Vseobecna fakultni nemocnice V Praze, Praha 2, 128 08, Czechia|INS Bergonié, Bordeaux cedex, 33076, France|HOP Morvan, Brest, 29609, France|Centre Hospitalier Départemental Les Oudairies, La Roche sur Yon, 85025, France|HOP Haut-Lévêque, Pessac, 33600, France|Hôpital la Milétrie - CHU Poitiers, Poitiers, 86021, France|Gesundheitszentrum Wetterau gGmbH, Bad Nauheim, 61231, Germany|Universitätsklinikum Carl Gustav Carus Dresden, Dresden, 01307, Germany|Universitätsklinikum Freiburg, Freiburg, 79106, Germany|Haemato-Onkologie Hamburg, Hamburg, 21075, Germany|Klinikum Kassel GmbH, Kassel, 34125, Germany|General Hospital of Athens G. Gennimatas , Athens, 11527, Greece|Semmelweis University, 1st Dept. Internal Medicine, Budapest, 1083, Hungary|Auckland Clinical Studies Ltd, Auckland, 1010, New Zealand|Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer, Warszawa, 02-781, Poland|BHI of Omsk region - Clinical Oncology Dispensary, Omsk, 644013, Russian Federation|St. Petersburg GUZ City Clinical Oncology Dispensary, St. Petersburg, 198255, Russian Federation|Hospital Germans Trias i Pujol, Badalona, 08916, Spain|Hospital Puerta del Mar, Cádiz, 11009, Spain|Fundación Jiménez Díaz, Madrid, 28040, Spain|Hospital Virgen del Rocío, Sevilla, 41013, Spain

{ "BI 695500": [ { "intervention_type": "DRUG" } ], "Rituximab": [ { "intervention_type": "DRUG", "description": "MabThera", "name": "Rituximab", "synonyms": [ "Mabthera", "rituximab-abbs", "MabThera", "Rituximab CD20 Antibody", "IDEC C2B8", "Rituximab", "GP2013", "Truxima", "rituximab-arrx", "IDEC-C2B8", "IDEC-C2B8 Antibody", "Rituxan", "CD20 Antibody, Rituximab", "rituximab-pvvr", "IDEC C2B8 Antibody" ], "medline_plus_id": "a607038", "generic_names": [ "Rituximab" ], "mesh_id": "D000074322", "drugbank_id": "DB00073", "wikipedia_url": "https://en.wikipedia.org/wiki/Rituximab" } ] }

NCT05317273

Urosepsis in Patients With Urinary Tract Calculi Receiving Surgical Intervention

https://clinicaltrials.gov/study/NCT05317273

RECRUITING

Urosepsis is one of major cause of the overall sepsis leading to high morbidity and mortality, which commonly resulted from urinary tract calculi. The investigator aim to identified the incidence and risk factors of urosepsis in the patients with urinary tract calculi underwent surgical intervention in tertiary-care university hospital.

NO

Urosepsis|Urinary Tract Stone

Rate of urosepsis diagnosis, According to urine exam and SIRS criteria of sepsis, 7 days after surgery|Date of urosepsis diagnosis, date of diagnosis of urosepsis, 7 days after surgery|Mortality rate, Number of deceased patient after surgery, 30 days after surgery

Length of stay, * hospital stay * intensive care unit stay, 7 days after surgery|Rate of intensive care unit admission, Number of patients required ICU admission, 7 days after surgery|Rate of blood transfusion, Amount of blood transfusion in unit during admission, 7 days after surgery|Rate of mechanical ventilation requirement, Number of patient required mechanical ventilation support, 7 days after surgery|Rate of re-operation, Number of patients require second procedure at the same admission, 7 days after surgery|Prevalence of acute kidney injury, According to KDIGO criteria, 30 days after surgery|Rate of renal replacement therapy requirement, Number of patients require renal replacement therapy, 30 days after surgery

Mahidol University

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2022_1

2022-08-01

2024-03-31

2024-04-30

2022-04-07

2024-01-31

Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok Noi, Bangkok, 10700, Thailand

{}

NCT05196373

Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars

https://clinicaltrials.gov/study/NCT05196373

NOT_YET_RECRUITING

Adult patients with hypertrophic scars 30 Subjects in Dose Escalation 20 Subjects in Dose Expansion Intrascar injection of STP705 weekly for 4 weeks

NO

Hypertrophic Scar

DRUG: STP705

Concentration of siRNA-TGF-B1 and siRNA-COX-2 in serum, siRNA-TGF-B1 and siRNA-COX-2 and HKP will be calculated, 7 weeks

Change of the scar from baseline using Observer Scar Assessment Scale, The scale will be used to record: vascularity, pigmentation, thickness, releif, pliability, surface area of the scar where 1= Normal skin and 10 = the worst case., 7 weeks|Change of the scar from baseline using Patient scale, The scale will be used to record: pain, itching, color, hardness, thickness, and relief where 1= No, not different from normal and 10 = Yes, very different from normal., 7 weeks

Sirnaomics

ALL

ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

SRN-705-009

2023-06

2024-12

2024-12

2022-01-19

2023-03-01

{ "STP705": [ { "intervention_type": "DRUG" } ] }

NCT03190473

OPTIMIZE IDE for the Treatment of ACS

https://clinicaltrials.gov/study/NCT03190473

OPTIMIZE

TERMINATED

Indication for use: The Svelte DES is indicated for improving coronary luminal diameter in patients with symptomatic heart disease, including patients with non-ST elevation MI due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 2.25 mm - 4.00 mm

NO

Acute Coronary Syndrome

DEVICE: DES

Target Lesion Failure (TLF), 12 months

Target Vessel Failure (TVF), 6 and 12 months, and annually through 5 years|Major Adverse Cardiac Event (MACE), 6 and 12 months and annually through 5 years follow-up|Stent Thrombosis, 6 and 12 months and annually through 5 years follow-up

Svelte Medical Systems, Inc.

ALL

ADULT, OLDER_ADULT

INDUSTRY

INTERVENTIONAL

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

IP-15-001

2018-01-02

2020-07-17

2023-03-08

2017-06-16

2023-03-23

Thomas Hospital, Fairhope, Alabama, 36532, United States|Scottsdale Healthcare, Scottsdale, Arizona, 85258, United States|Arkansas Heart Hospital, Little Rock, Arkansas, 72211, United States|Bakersfield Memorial Hospital, Bakersfield, California, 93301, United States|Mission Cardiovascular Research Institute (Washington Hospital), Fremont, California, 94538, United States|Long Beach VA Medical Center, Long Beach, California, 90822, United States|Keck Hospital of USC, Los Angeles, California, 90033, United States|San Francisco VA, San Francisco, California, 94121, United States|Christiana Hospital, Newark, Delaware, 19702, United States|Morton Plant Hospital, Clearwater, Florida, 33756, United States|Clearwater Cardiovascular Consultants, Clearwater, Florida, 34695, United States|Memorial Regional Hospital, Hollywood, Florida, 33021, United States|University of Miami Medical Center, Miami, Florida, 33125, United States|Mediquest (Munroe Regional Medical Center), Ocala, Florida, 34471, United States|Tallahassee Research Institute, Tallahassee, Florida, 32303, United States|Jesse Brown VAMC, Chicago, Illinois, 60637, United States|University of Chicago Medical Center, Chicago, Illinois, 60637, United States|Amita/Adventist Heart and Vascular, Hinsdale, Illinois, 60521, United States|Elkhart General Healthcare, Elkhart, Indiana, 46514, United States|St Vincent Heart Center of Indiana, Indianapolis, Indiana, 46290, United States|Mercy Hospital Medical Center, Des Moines, Iowa, 50314, United States|Union Memorial Hospital, Baltimore, Maryland, 21218, United States|Massachusetts General Hospital, Boston, Massachusetts, 02114, United States|Brigham and Women s Hospital, Boston, Massachusetts, 02115, United States|Borgess Heart Center, Kalamazoo, Michigan, 49008, United States|Northern Michigan Hospital d.b.a McLaren Northern Michigan, Petoskey, Michigan, 49770, United States|William Beaumont Hospital, Royal Oak, Michigan, 48073, United States|St. Mary s Duluth Clinic, Duluth, Minnesota, 55805, United States|Mayo Clinic, Rochester, Minnesota, 55905, United States|North Mississippi Health Services, Tupelo, Mississippi, 38801, United States|St. Luke s Hospital, Kansas City, Missouri, 64111, United States|Washington University School of Medicine, Saint Louis, Missouri, 63110, United States|Deborah Heart and Lung Center, Browns Mills, New Jersey, 08015, United States|Morristown Medical Center, Morristown, New Jersey, 07960, United States|Montefiore Medical Center, Bronx, New York, 10467, United States|NYU Winthrop Hospital, Mineola, New York, 11501, United States|NYU Langone Medical Center, New York, New York, 10016, United States|Weill Cornell Medical Center, New York, New York, 10021, United States|Rochester General Hospital, Rochester, New York, 14621, United States|St. Joseph s Hospital Health Center, Syracuse, New York, 13203, United States|Durham VA Medical Center, Durham, North Carolina, 27705, United States|Moses Cone Memorial Hospital, Greensboro, North Carolina, 27401, United States|North Carolina Heart and Vascular, Raleigh, North Carolina, 27607, United States|The Christ Hospital, Cincinnati, Ohio, 45219, United States|Riverside Methodist Hospital, Columbus, Ohio, 43214, United States|Lehigh Valley Hospital, Allentown, Pennsylvania, 19103, United States|Hershey Medical Center, Hershey, Pennsylvania, 17033, United States|Robert Packer Hospital, Sayre, Pennsylvania, 18840, United States|Texas Heart Institute, Houston, Texas, 77030, United States|The Methodist Hospital, Houston, Texas, 77030, United States|Austin Heart, Round Rock, Texas, 78681, United States|South Texas Cardiology Institute, San Antonio, Texas, 78212, United States|University of Virginia Medical Center, Charlottesville, Virginia, 22908, United States|Swedish Hospital Medical Center, Seattle, Washington, 98122, United States|Shonan Kamakura General Hospital, Kamakura, Japan|Kanazawa Cardiovascular Hospital, Kanazawa, Japan|Kokura Memorial Hospital, Kitakyushu, Japan|Medical Corporation Association Sakura Association Takahashi Hospital, Kobe, Japan|Ohara Healthcare Foundation Kurashiki Central Hospital, Kurashiki, Japan|Shin Koga Hospital, Kurume, Japan|Miyazaki Medical Association, Miyazaki, Japan|The Sakakibara Heart Institute of Okayama, Okayama, Japan|Sapporo Higashi Tokushukai Hospital, Sapporo, Japan|Meander Medisch Centrum, Amersfoort, Netherlands|OLVG loc Oost, Amsterdam, Netherlands|Tergooi Ziekenhuis, Blaricum, Netherlands|Amphia Ziekenhuis, Breda, Netherlands|HAGA Ziekenhuis, Den Haag, Netherlands|Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands|Catharina Ziekenhuis, Eindhoven, Netherlands|St Antonius Ziekenhuis, Nieuwegein, Netherlands|UMC Utrecht, Utrecht, Netherlands

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

NCT06049173

Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis

https://clinicaltrials.gov/study/NCT06049173

COMPLETED

1. Oxygenation index and bedside ultrasound would be used to evaluate the therapeutic effect of novel recruitment maneuver therapy in the patients with pulmonary atelectasis after cardiac surgery. 2. To establish a new therapy strategy for pulmonary atelectasis after cardiac surgery and to evaluate its effectiveness and safety for the cardiac patients complicated with postoperative pulmonary atelectasis.

NO

Postoperative Pulmonary Atelectasis

OTHER: novel recruitment maneuver therapy

Pulmonary ultrasound, Pulmonary ultrasound score (LUS score) , minimum value 0 to maximum value 36. The higher the score, the more severe the loss of lung ventilation, 1 hour before treatment and 1 hour after treatment

Jilai Xiao

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

KY20230829-04

2023-09-20

2024-04-20

2024-04-20

2023-09-22

2024-05-16

Nanjing First Hospital, Nanjing, Nanjing, 210000, China

{ "novel recruitment maneuver therapy": [ { "intervention_type": "OTHER" } ] }

NCT00327873

Palliative Oxygen for the Relief of Breathlessness

https://clinicaltrials.gov/study/NCT00327873

COMPLETED

The main goal of this study is to establish the effectiveness of palliative oxygen in the context within which it is usually provided--relief of the sensation of breathlessness and improvement in quality of life for people with maximally-treated life-limiting illness.

NO

Dyspnea

OTHER: Oxygen|OTHER: Medical Air

Changes in relief from the sensation of breathlessness, 7 days

Changes in quality of life (QOL), 7 days|Identification of patients who benefit from palliative oxygen, 7 days|Identification of side effects, 7 days|Documentation of costs of palliative oxygen, 7 days

National Health and Medical Research Council, Australia

Doris Duke Charitable Foundation|Cancer Council Tasmania|Duke Institute on Care at the End of Life, USA|Flinders Medical Research Institute Small Research Grants Scheme, Australia

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

AG0064

2005-05

2008-03

2008-03

2006-05-19

2009-12-14

Duke University Department of Medicine, Division of Medical Oncology, Durham, North Carolina, 27710, United States|Sydney Area Health Service, Sydney Cancer Centre, Sydney, New South Wales, 2050, Australia|Flinders University, Southern Adelaide Palliative Services, Adelaide, South Australia, 5041, Australia|Statewide Palliative Care Service, Launceston, Tasmania, 7250, Australia|Austin Health, Melbourne, Victoria, 3084, Australia|St Nicholas Hospice, Cambridge, IP33 2QY UK, United Kingdom|Nottingham University, Nottingham, NG5 1PB, United Kingdom

{ "Oxygen": [ { "intervention_type": "OTHER" } ], "Medical Air": [ { "intervention_type": "OTHER" } ] }

NCT01690273

Exercise Therapy Program in Ankylosing Spondylitis Patients

https://clinicaltrials.gov/study/NCT01690273

COMPLETED

Mobility exercises are used in Ankylosing Spondylitis (AS) patients to preserve and restore axial mobility, but there are no data regarding a specific rehabilitation program that includes flexibility alone and its association with resistance exercises in AS patients with stable disease activity. So, we assessed the effects of two exercise programs in terms of mobility, functional capacity, quality of life and disease activity in AS patients. Methods. Fifty-five sedentary AS patients with a Bath Ankylosing Spondylitis Activity Index (BASDAI) <4 were included.

YES

Ankylosing Spondylitis

OTHER: mobility exercise|OTHER: mobility and elastic resistance exercise

FUNCTIONAL INDEX, BASFI - Bath ankylosing spondylitis functional index. A scale from 0 to 10 (lower scores means better functional capacity), results are measured by mean and standard deviation., Baseline and 16 Weeks|Mobility Index, Bath ankylosing spondylitis motion index. A mean of five mobility measures committed by Ankylosing Spondylitis disease. Higher results means higher limitations in mobility (units of measure from 0 to 10), Baseline and 16 weeks|Disease Activity Index, BASDAI - Bath ankylosing spondylitis disease activity index. Scale from 0 to 6. Higher scores means worst disease activity. Numbers are expressed in average (SD), Baseline and 16 Weeks|Ankylosing Spondylitis Disease Activity Scale -Disease Activity, Scores vary from 0 to 10, and higher than 4 scores are indicative of disease activity. Data are expressed by means and SD, Baseline and 16 Weeks|Global Evaluation Self Reported, Bath Ankylosing Spondylitis Global is a self reported global score varying from 0 to 10. Higher scores means worst health evaluation. Expressed by means and standard deviation., Baseline and 16 Weeks

Thoracolumbar Mobility, Thoracolumbar rotation Pavelka. Measured with a tape in centimeters. Higher number means better thoracolumbar rotation, Baseline and 16 Weeks|Pain Scale, Pain was evaluated in a visual analogue scale (VAS) from 0 to 10. higher scores means much pain. Data was expressed by means and standard deviation., Baseline and 16 Weeks|Stiffness Scale, Stiffness was measured by an VAS varying from 0 to 10. Higher scores means worst stiffness. Data are expressed by mean and SD., Baseline and 16 Weeks|Short Form-12 (PCS), Quality of life was analyzed in a physical component score varying from 0 (lowest level of health) to 100 (highest level of health) scale. Data are expressed by mean and SD., Baseline and 16 Weeks|Short Form-12 (MCS), Quality of life was analyzed in a mental component score varying from 0 (lowest level of health) to 100 (highest level of health). Data are expressed by mean and SD., Baseline and 16 Weeks|MASES, Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) score varying from 0 to 13. Where 0 is no painful point reported and 13 is all tender points reported as painful. Data are expressed by means and standard deviation, Baseline and 16 Weeks|Chin-coronoid Distance, lateral rotation of the head (chin-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral rotation mobility. Data are expressed by means and standard deviation, Baseline and 16 Weeks|Tragus-coronoid Distance, lateral flexion of the head (tragus-coronoid distance) was measured with a tape in centimeters. Highest score means better lateral flexion mobility of the head.Data are expressed by means and standard deviation, Baseline and 16 Weeks|Finger Floor Distance, Distance between third finger of the hand and the floor while in lumbar flexion. It was measured with a tape in centimeters. Highest score means better torso flexion mobility. Data are expressed by means and standard deviation, Baseline and 16 Weeks|Chest Expansion, Chest expansion was measured with a tape in centimeters between inspiration and breathing exhaling. Highest score means better chest expansion. Data are expressed by means and standard deviation., Baseline and 16 Weeks

University of Sao Paulo

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

8206212

2012-07

2013-06

2014-11

2012-09-21

2016-10-20

2016-10-20

University of Sao Paulo, Sao Paulo, 05403-010, Brazil

{ "mobility exercise": [ { "intervention_type": "OTHER" } ], "mobility and elastic resistance exercise": [ { "intervention_type": "OTHER" } ] }

NCT04307173

Study of Multiple Ascending Dose of KBL693 in Healthy Participants

https://clinicaltrials.gov/study/NCT04307173

COMPLETED

The study is designed to investigate the safety and tolerability of KBL693 in healthy volunteers. KBL693 has been developed as a potential new treatment for moderate to severe asthma..

NO

Moderate to Severe Asthma

DRUG: KBL693|DRUG: KBL693

Safety and tolerability measure through Adverse Events/Serious Adverse Events, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, Measurements at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- blood pressure, Measured by result of the Vital Sign- blood pressure, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign-heart rate, Measured by result of the Vital Sign- heart rate, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- axillary body temperature, Measured by result of the Vital Sign- axillary body temperature, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Vital Sign- respiratory rate, Measured by result of the Vital Sign- respiratory rate, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through 12-lead ECG, Measured by result of the ECG measurements and findings, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Physical exam, Measured by result of the physical exam which includes general appearance, skin, eyes/ears/nose/throat, head and neck, cardiovascular, respiratory, abdomen, extremities, lymph nodes, musculoskeletal and neurologic, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Routine Stool Examination, Measured by result of the Bristol Stool Examination, Occult blood, Parasites, Measurement at Baseline till 28 days|Safety and tolerability(Incidence of Treatment-Emergent Adverse Events) measure through Clinical laboratory results, Measured by clinically significant change from baseline clinical laboratory results, Measurement at Baseline till 28 days

Difference in the change from baseline in profile of faecal KBL693 between treatment arms, Measured by quantitative analysis method for understanding distribution and excretion of KBL693, Measurements at Baseline till 28 days

KoBioLabs

Novotech (Australia) Pty Limited

ALL

ADULT, OLDER_ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

KBL-CURE-2020-01

2020-08-14

2020-10-30

2020-11-12

2020-03-13

2021-02-21

Linear Clinical Research, Nedlands, Western Australia, 6009, Australia

{ "KBL693": [ { "intervention_type": "DRUG" }, { "intervention_type": "DRUG" } ] }

NCT04781673

Ketamine vs Lidocaine in Traumatic Rib Fractures

https://clinicaltrials.gov/study/NCT04781673

RECRUITING

Rib fractures continue to be a common occurrence in trauma patients of all ages. Traumatic rib fractures can cause severe pain in patients and lead to shallow breathing and further complications such as the need for mechanical ventilation, hospital or ventilator associated pneumonia, atelectasis, and acute respiratory distress syndrome. Effective multimodal pain management is needed to optimize a patient s respiratory status and can also play a role in early mobility, less pulmonary complications, shorter ICU and hospital length of stay, and decreased mortality. Current multimodal pain management options include opioids, muscle relaxants, gabapentin, acetaminophen, nonsteroidal anti-inflammatory drugs, and various regional/neuraxial anesthesia techniques. Both ketamine and lidocaine infusions for pain control have also been shown in studies to be safe and effective, with the benefit of minimizing the use of opioids. However, there have been very few studies that have used ketamine or lidocaine infusions for pain control specifically in patients with traumatic rib fractures. Therefore, the purpose of this study is to evaluate ketamine versus lidocaine infusions as an adjunctive therapy to reduce opioid consumption in the first 72 hours in patients with multiple traumatic rib fractures.

NO

Rib Fractures|Rib Fracture Multiple|Rib Trauma

DRUG: Ketamine|DRUG: Lidocaine

Oral Morphine Equivalent - Opioid Usage, Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg., 0-24 hours post infusion

Visual Analogue Numeric Pain Score, Visual Analogue Numeric Pain Score are recorded as a scale of 1-10, with 0 being no pain and 10 as worst imaginable pain. Patient will be asked their pain score every 6 hours., 0-24; 24-48; 48-72 hours post infusion|Oral Morphine Equivalent - Opioid Usage, Oral morphine equivalence is a way to track the amount of opioids used by standardizing all opioid utilizations and converting them to daily morphine equivalence in mg., 24-48; 48-72 hours post infusion|Respiratory Failure, Respiratory failure was defined by need for mechanical intubation, 0-30 days post-infusion|Use of Regional/Neuraxial anesthesia, Measure of regional/neuraxial anesthesia placement rates. Patient would need to be taken off study medication if decision made to place regional/neuraxial anesthetic., 0-30 days post infusion|Hospital Length of Stay, Total hospital length of stay up to 365 days, Will capture retrospectively after patient s medical discharge|Intensive Care Unit Length of stay, Total intensive care unit length of stay up to 365 days, Will capture retrospectively after patient s medical discharge|Incentive Spirometry, Measure of percent improvement in incentive spirometry level from baseline (before infusion). Incentive spirometry levels range from 0-4,000 mL., 0-24; 24-48; 48-72 hours post infusion|Adverse events, Number of participants with treatment-related adverse events as assessed by CTCAE v5.0, 0-72 hours post infusion|In-Hospital mortality, Patient s death will be recorded if it occurs before discharge, Will capture retrospectively after patient s medical discharge

Brittany Hoyte

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

2019-508

2021-04-01

2025-07

2026-01

2021-03-04

2024-04-23

Spectrum Health Hospital, Grand Rapids, Michigan, 49503, United States

{ "Ketamine": [ { "intervention_type": "DRUG", "description": "Ketamine", "name": "Ketamine", "synonyms": [ "CI 581", "Ketanest", "2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone", "Calipsol", "2-(o-chlorophenyl)-2-(methylamino)-cyclohexanone", "2-(methylamino)-2-(2-chlorophenyl)cyclohexanone", "DL-ketamine", "Ketamine", "NMDA", "CI-581", "Ketaset", "Special K", "(\u00b1)-ketamine", "Ketamina", "Calypsol", "Ketamine Hydrochloride", "K\u00e9tamine", "Kalipsol", "Ketaminum", "Ketalar", "(+-)-Ketamine", "CI581", "2-(2-Chloro-phenyl)-2-methylamino-cyclohexanone" ], "mesh_id": "D018691", "generic_names": [ "Ketamine" ], "drugbank_id": "DB01221" } ], "Lidocaine": [ { "intervention_type": "DRUG", "description": "Lidocaine", "name": "Lidocaine", "synonyms": [ "Boots Haemorrhoid", "2-(Diethylamino)-2',6'-acetoxylidide", "2-2EtN-2MePhAcN", "\u03b1-diethylamino-2,6-dimethylacetanilide", "Xylocaine", "Lidocaine Monohydrochloride, Monohydrate", "Lidocaine Carbonate", "Xyloneural", "2-(Diethylamino)-N-(2,6-dimethylphenyl)acetamide", "Ztlido", "EMLA", "Lidocaina", "Lidocaine", "2-(Diethylamino)-N-(2,6-Dimethylphenyl)Acetamide", "Covonia", "Xylopract", "Nulbia", "Lidoca\u00edna", "Octocaine", "Lidocainum", "LMX4", "Bonjela", "Lidocaine Hydrochloride", "Dalcaine", "Lidocaine Sulfate (1:1)", "Anbesol", "Perinal", "Anusol", "Lidocaine Monohydrochloride", "Germaloids", "Iglu", "Xylesthesin", "Lidocaine Monoacetate", "Lignocaine", "Calgel", "Lidocaine Carbonate (2:1)", "Denela", "Lidocaine Hydrocarbonate", "alpha-diethylamino-2,6-dimethylacetanilide", "Xylocitin", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Dermalid", "Ztlido", "Lidoderm", "Absorbine Jr", "Lidocaine Patch", "Xylocaine", "Lidocaine Viscous", "Xylocaine", "Lidocaine Viscous", "Senstend", "Emla", "Fortacin", "Lidocaine/prilocaine", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort", "Epicortisol", "11beta-hydrocortisone", "Neosporin", "Anugesic", "Kendall's compound F", "Cortisol", "Hydrocortisone", "Stie-Cort", "Efmody", "Dermacort", "Texacort", "A-Hydrocort", "Uniroid", "Plenadren", "Hidrocortisona", "Hydrocortisonum", "Xyloproct", "Hydrocortone", "11\u03b2-hydrocortisone", "Cortizone 10", "Cortifoam", "Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-", "Locoid", "Proctosedyl", "Cortifair", "Dermasorb", "HC45", "11 Epicortisol", "Cortef", "Perinal", "Anusol", "Germaloids", "(11\u03b2)-11,17,21-trihydroxypregn-4-ene-3,20-dione", "17-Hydroxycorticosterone", "Anusol HC", "Cortril", "Hydrocortisone, (11 alpha)-Isomer", "Preparation H Anti-Itch", "Derma Care", "Pandel", "11beta,17alpha,21-Trihydroxy-4-pregnene-3,20-dione", "11-Epicortisol", "4-pregnen-11\u03b2,17\u03b1,21-triol-3,20-dione", "Hydrocortisone, (9 beta,10 alpha,11 alpha)-Isomer", "Reichstein's substance M", "Ala-Cort" ], "nhs_url": "https://www.nhs.uk/medicines/lidocaine-for-piles-and-itchy-bottom", "generic_names": [ "Lidocaine", "Lidocaine Patch", "Lidocaine Patch", "Lidocaine Viscous", "Lidocaine Viscous", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone", "Hydrocortisone" ], "mesh_id": "D061567", "drugbank_id": "DB00281", "wikipedia_url": "https://en.wikipedia.org/wiki/Lidocaine" } ] }

NCT01994473

Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia

https://clinicaltrials.gov/study/NCT01994473

SEP-363856

COMPLETED

This is a study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.

NO

Schizophrenia

DRUG: SEP-363856|DRUG: Placebo|DRUG: SEP-363856 Open Label

Frequency of AEs, SAEs, and AEs resulting in study discontinuation in Parts 1 and 2., Up to 57 days|Absolute values and changes from baseline in clinical laboratory tests, vital signs, 12-lead ECGs, and findings from neurological examinations in Parts 1 and 2, Absolute values and changes from baseline in clinical laboratory tests (hematology, serum chemistry, urinalysis, lipid panel, coagulation panel, thyroid panel, and serum prolactin), vital signs (blood pressure [supine and standing], heart rate [supine and standing], respiration rate, and body temperature), 12-lead ECGs, and findings from neurological examinations in Parts 1 and 2, Up to 57 days|Frequency of subjects with suicidal ideation or suicidal behavior using the Columbia-Suicide Severity Rating Scale (C-SSRS) in Parts 1 and 2., Up to 57 days

Plasma SEP-363856 and metabolite SEP-363854 maximum observed concentration (Cmax), Part 1, Day 1 (following first dose)|Plasma metabolite to parent ratio for Cmax (MRCmax) and AUC0-24 (MRAUC0-24)., Part 1, Day 1 (following first dose)|Plasma SEP-363856 and metabolite SEP-363854 Cmax, tmax, AUC0-tau, terminal elimination half-life (t1/2), and accumulation ratios based on Cmax (RCmax), and AUC0-tau (RAUC0-tau)., Part 1, Day 7 (following last dose)|Plasma metabolite to parent ratio for Cmax (MRCmax) and AUC0-tau (MRAUC0-tau)., Part 1, Day 7 (following last dose)|Plasma SEP-363856 steady-state apparent volume of distribution (Vss/F)., Day 7 (following last dose)|SEP-363856 and metabolite SEP-363854 renal clearance (CLR) and fraction excreted (fe) expressed as percent of administered dose., Part 1, Day 7 (following last dose)|SEP-363856 and SEP-363854 amount excreted (Ae) in urine., Part 1, Day 7 (following last dose)|Plasma SEP-363856 and metabolite SEP-363854 time of occurrence of Cmax (tmax), Part 1, Day 1 (following first dose)|Plasma SEP-363856 and metabolite SEP-363854 area under the concentration-time curve (AUC0-24)., Part 1, Day 1 (following first dose)|Plasma SEP-363856 steady-state apparent clearance (CLss/F), Part 1, Day 7 (following last dose)|Plasma SEP-363856 and metabolite SEP-363854 Cmax, tmax, and AUC0-24, Part 2, Day 13

Otsuka Pharmaceutical Development & Commercialization, Inc.

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

SEP361-106

2013-10

2014-12

2014-12

2013-11-25

2024-06-26

California Clinical Trials Medical Group, Glendale, California, 91206, United States|Collaborative Neuroscience Network, LLC, Long Beach, California, 90806, United States

{ "SEP-363856": [ { "intervention_type": "DRUG", "description": "SEP-363856", "name": "SEP-363856", "synonyms": [ "", "SEP-363856" ], "drugbank_id": "DB15665", "generic_names": [ "SEP-363856" ] }, { "intervention_type": "DRUG", "description": "SEP-363856 Open Label", "name": "SEP-363856", "synonyms": [ "", "SEP-363856" ], "drugbank_id": "DB15665", "generic_names": [ "SEP-363856" ] } ], "Placebo": [ { "intervention_type": "DRUG" } ] }

NCT06079073

The Effect of Orofacial Myofunctional Therapy With Autofeedback on Obstructive Sleep Apnea

https://clinicaltrials.gov/study/NCT06079073

OMTAOSA

RECRUITING

The overall aim of this study is to estimate the effect of orofacial myofunctional therapy (OMT) plus auto-monitoring compared to auto-monitoring alone. Moreover, the investigators aim to identify anatomical and behavioural predictors of OMT adherence

NO

Sleep Apnea, Obstructive

BEHAVIORAL: Orofacial myofunctional therapy with autofeedback

Apnea hypopnea index reduction, Measured by self-applied somnography. The index represents number of apneas or hypopneas per hour from 0/h. Higher values represents more severe disease., 3 months

Change in the Epworth Sleepines scale, The scale is a validated tool measuring sleepiness between 0-24. Higher values represent more sleepiness, 3 months|Orofacial myofunctional therapy adherence, Measured by application registration between 1-3 per day. Three exercises per day is the maximum score, 3 months|Change in desaturation severity parameter measured by medical device, Measured by photoplethysmography obtained by self-applied somnography. More severity represents more disease., 3 months|Change in desaturation duration measured by medical device, Measured by photoplethysmography obtained by self-applied somnography. Longer duration represents more disease., 3 months|Change in objective sleep quality, Measured by self-applied somnography. Sleep quality is the ratio between total sleep time and time in bed. A higher ratio is better., 3 months|Change in desaturation severity parameter measured by wearable, Measured by photoplethytsmography obtained by Withings Scan Watch. More severity represents more disease., 3 months|Change in desaturation duration measured by wearable, Measured by photoplethytsmography obtained by Withings Scan Watch. Longer duration represents more disease., 3 months|Change in stroop test, Measured by Flexibility game in application. More correct answers is better, 3 months|Change in reaction test, Measured by reaction game in application. Shorter reaction time is better, 3 months|Change in memory test, Measured by memory game in application. Longer sequences memorized is better, 3 months|Change in perception test, Measured by perception game in application. More correct answers is better., 3 months|Change general health status, Measured by a visual analogue scale in the BEAMER questionnaire, two visio analogue scales on general health and 3 items on acceptance and control scored 1-6 respectively., 3 months|Changes in the Orofacial Myofunctional Evaluation with Scores, Measured by scorer blinded for randomization. Range 37-103. A lower score represents more dysfunction., 3 months|Changes in tongue strength, Objective strength measured by the Iowa Oral Pressure Inventory. A higher score represents more strenght., 3 months|Changes in tongue endurance, Objective endurance measured by the Iowa Oral Pressure Inventory. A higher score represents more endurance., 3 months

University Hospital, Akershus

University of Oslo|Oslo Metropolitan University|University of Tartu|Reykjavik University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

22/11571

2023-08-29

2024-06-30

2025-08-31

2023-10-12

2023-10-12

Fertilitas clinic, Tallinn, 10114, Estonia|Akershus University Hospital, Lørenskog, Akershus, 1478, Norway

Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT06079073/Prot_SAP_000.pdf

{ "Orofacial myofunctional therapy with autofeedback": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00846573

Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders

https://clinicaltrials.gov/study/NCT00846573

TERMINATED

The purpose of this study is to test the efficacy of Hyperpolarized Helium-3 gas in MR imaging in COPD, asthmatics, CF and healthy volunteers.

YES

COPD|Cystic Fibrosis|Asthma|Healthy

DRUG: Hyperpolarized Helium-3

Hyperpolarized Helium-3 MR Images, We have applied hyperpolarized 3He MR imaging to a range of subject with various disorders. We have developed our scanning techniques so as to acquire optimized images for each disorder., 15 second breath-hold

University of Massachusetts, Worcester

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

Docket # 12639

2008-11

2011-04

2011-04

2009-02-18

2012-11-09

2012-11-15

UMASS Medical School Advanced MRI Center United States, Worcester, Massachusetts, United States

{ "Hyperpolarized Helium-3": [ { "intervention_type": "DRUG" } ] }

NCT00473473

Effect of the Homeopathic Remedy Kalium Bichromicum (Potassium Dichromate) on Viscosity and Amount of Sputum and Time to Extubation in Mechanically Ventilated ICU Patients.

https://clinicaltrials.gov/study/NCT00473473

UNKNOWN

ICU-Protocol.Summary Profuse and tenacious tracheal secretions are a significant factor impeding the weaning process in mechanically ventilated patients in the intensive care unit (ICU). In homeopathy, high dilutions of plant extracts, minerals, and other biological substances are used as remedies for the treatment of illness, which is based on the Law of Similars (the higher the dilution, the stronger the effect). Kali Bichromicum (potassium dichromate) is a drug that is commonly used in homeopathy, mostly for conditions involving profuse, stringy, tenacious mucous and tracheal secretions. A recent randomized, double-blind, placebo-controlled study found a statistically significant effect of this remedy on improving the amount of tracheal secretion, timing to extubation and discharge from the ICU among critically ill patients, with no side effects observed. The proposed study will compare the efficacy of Kali bichromicum 10-60 (C30) versus placebo in reducing the amount of tracheal secretions in patients intubated with a conventional endotracheal tube or tracheostomy and receiving controlled mechanical ventilation in the ICU setting. The quantity of the secretions will be studied, as well as sputum neutrophil count (using direct microscopy). Time to extubation and the need for re-intubation will also be evaluated. 56 patients over the age of 18 years treated with mechanical ventilation for at least 3 days will be recruited from the ICU departments of 4 medical centers in Israel. The preparations will be administered in the form of small pellet-like globules, which will be placed on the mucosa of the mouth, to the side of the endotracheal tube. Patients will be randomly allocated to either verum (n=28) or placebo (n=28) treatment, with the remedies administered twice daily with an interval of 12 hours, for a period of up to 14 days or until the patient is extubated. Any adverse event will be recorded.

NO

Mechanical Ventilation

DRUG: Potassium Dichromate (Homeopathy)|DRUG: Placebo homeopathic remedy

the amount of tracheal secretions in patients intubated with a conventional endotracheal tube and receiving controlled mechanical ventilation with a respirator two days after the initiation of the study., 14 days

grade 3 tracheal secretions, number of suctionings and sputum neutrophil count on day 2; tracheal secretions on day 14/extubation; time to extubation and need for re-intubation; time to discharge; safety of of Kali bichromicums after 14 days/extubation., 14 days

Shaare Zedek Medical Center

Hadassah Medical Organization

ALL

ADULT, OLDER_ADULT

PHASE3

OTHER

INTERVENTIONAL

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

KaliBic.ICU.07

2008-07

2012-12

2012-12

2007-05-15

2012-02-22

Intensive Care Unit, Shaare Zedek Medical Center, Jerusalem, 91031, Israel|Dept. of Internal Medicine, Intensive Care Unit G8, Hadassah University Hospital, Ein Kerem, Jerusalem, Israel

{ "Potassium Dichromate (Homeopathy)": [ { "intervention_type": "DRUG" } ], "Placebo homeopathic remedy": [ { "intervention_type": "DRUG" } ] }

NCT01627873

Effect of Remifentanil on Postoperative Cognition Function in Patients Undergoing Major Abdominal Surgery

https://clinicaltrials.gov/study/NCT01627873

COMPLETED

The purpose of this study is to investigate the effects of two different analgesic methods (Fentanyl vs Remifentanil) during major abdominal surgery on postoperative cognitive status of patients.

NO

Patients Undergoing Major Abdominal Surgery|Postoperative Confusion

DRUG: Remifentanil|DRUG: Fentanyl

Rey verbal memory test of words before and after major abdominal surgery, In test of Rey to the subject is presented for 5 times the same list of 15 bisyllabic words or trisillabic common use of which he must recall as many as possible within 1 minute; after about 15 minutes the patient, meanwhile distracted by the test , must again try to remember the greatest number possible without a further reading. The maximum possible score of the first phase of the test is an expression of the ability of short term memory of the subject, the result of the test is repeated at a distance of 15 minutes is indicative of its storage capacity, to intermediate term., participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days|Stroop Test before and after surgery, In the Stroop Test patient is instructed to read a random sequence of adjectives green , red , blue written in black font, then he refers the colour of a succession of circumferences filled of the three colors above in random order; finally, another random succession of three words green , red , blue written in three characters of the same colors, but not associated with corresponding adjective. Number of errors that the subject does in reading is an indication of its ability to attention, participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days

Quantitative determination of serum pro and anti inflammatory cytokines before and after surgery, Blood samples will be made for the quantitative determination of serum cytokines IL-1β, IL-6, IL-8, TNF-α, IL-10 and IL-12. Determinations will be given by Multiplex Elisa method., participants will be followed the day before and after surgery and for the duration of hospital stay, an expected average of 5 days

Catholic University of the Sacred Heart

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

A/575/2009

2009-08

2011-07

2011-12

2012-06-26

2012-06-26

Policlinico Universitario A.Gemelli , Rome, 00168, Italy

{ "Remifentanil": [ { "intervention_type": "DRUG", "description": "Remifentanil", "name": "Remifentanil", "synonyms": [ "Remifentanil Monohydrochloride", "3-(4-Methoxycarbonyl-4-((1-oxopropyl)phenylamino)-1-piperidine)propanoic Acid Methyl Ester", "GI87084B", "Remifentanyl", "Remifentanil", "GI 87084B", "Remifentanil Hydrochloride", "Ultiva", "Remifentanilo", "GI-87084B" ], "mesh_id": "D000701", "generic_names": [ "Remifentanil" ], "drugbank_id": "DB00899" } ], "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" } ] }

NCT01428973

Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens

https://clinicaltrials.gov/study/NCT01428973

ACTIVE_NOT_RECRUITING

The present project is a multicenter phase II trail aiming at comparing which of the two postgrafting immunosuppressive regimens proposed in this study will be best suited to prevent graft-versus-host disease (GVDH). The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity conditioning with Fludarabine/total body irradiation (TBI) or Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014, the protocol has been amended to allow inclusion only after Flu-TBI conditioning. The hypothesis is that the Tacrolimus plus Sirolimus regimen will be associated with better progression-free survival due to a lower incidence of relapse/progression.

NO

Graft-Versus-Host Disease|Hematological Malignancies

DRUG: Mycophenolate mofetil|DRUG: Sirolimus

Progression-free survival, To compare the 1-year progression-free survival between the 2 prophylactic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus) in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 1 year after transplantation

Relapse rate; nonrelapse mortality and overall survival, To compare relapse rate, nonrelapse mortality, and overall survival in the 2 prophyltic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus) 1, 2 and 5 years after hematopietic stem cell transplantation (HSCT) in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 1, 2 and 5 years after transplantation|Progression free survival, To compare progression-free survival in the 2 phrophylactic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus) 2 and 5 years after HSCT, in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 2 and 5 years after transplantation|Engraftment, To compare hematopoietic (whole blood and T cell chimerism) engraftment and to evaluate the 1-year incidence of graft rejection in the 2 prophylctic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus), in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 1 year after transplantation|Acute GVDH, To compare the 6-mo incidence of grades II-IV and III-IV acute GVHD in the 2 prophylactic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus), in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 6 months after transplantation|Chronic GVDH, To compare the 1-yr incidence of chronic GVHD in the phrophylactic 2 prophylactic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus), in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 1 year after transplantation|Immunological reconstitution, To compare the quality and timing of immunologic reconstitution in the 2 prophylactic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus),in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 3 mo, 6 mo, 1 yr, 2 yrs and 5 yrs after transplantation|Infection, To compare the 1-yr incidences of bacterial, fungal and viral infections in the 2 prophylactic arms (Tracolimus/Mycophenolate Mofetil and Tracolimus/Sirolimus), in the whole group of patients and separately in those conditioned with Fluradabine/TBI or Fluradabine plus Busulfan and anti-thymocyte globulin., 1 year after transplantation

University of Liege

AZ Sint-Jan AV|Ziekenhuis Netwerk Antwerpen (ZNA)|Jules Bordet Institute|University Hospital, Gasthuisberg|AZ-VUB|Cliniques universitaires Saint-Luc- Université Catholique de Louvain|University Hospital, Antwerp|Cliniques Universitaires de Mont-Godinne|Hospital de Jolimont|University Hospital, Ghent|AZ Delta

ALL

CHILD, ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

TJB1016P1

2011-09

2024-12

2024-12

2011-09-05

2024-05-09

Ziekenhuis Netwerk Antwerpen (ZNA), Antwerpen,, Antwerpen, 2060, Belgium|University Hospital, Antwerp, Edegem, Antwerp, 2650, Belgium|Jules Bordet Institute, Brussels, Brabant, 1000, Belgium|Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Brussels,, Brussels Region Capital, 1200, Belgium|AZ VUB Jette, Brussels, Brussels Region Capital, 1090, Belgium|Queen Fabiola Children s University Hospital, Brussels, Brussels, Region Capital, 1020, Belgium|University Hospital, Gasthuisberg, Leuven, Flamish Brabant, 3000, Belgium|UZ Gent, Gent, Flanders Ost, 9000, Belgium|Jolimont Hospital Haine Saint Paul, Haine St-Paul, Hainaut, 7100, Belgium|Cliniques Universitaires de Mont-Godinne, Yvoir, Namur, 5530, Belgium|AZ Sint-Jan AV, Brugge, West Flanders, 8000, Belgium|H.-Hart Hospital Roeselare-Menen, Roeselare, Western Flanders, 8800, Belgium|CHU Sart Tilman, Liège, 4000, Belgium

{ "Mycophenolate mofetil": [ { "intervention_type": "DRUG", "description": "Mycophenolate mofetil", "name": "Mycophenolate mofetil", "synonyms": [ "Mycophenolate mofetil", "Mycophenolic acid morpholinoethyl ester", "2-morpholinoethyl (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-5-phthalanyl)-4-methyl-4-hexenoate" ], "drugbank_id": "DB00688", "generic_names": [ "Mycophenolate mofetil" ] } ], "Sirolimus": [ { "intervention_type": "DRUG", "description": "Sirolimus", "name": "Sirolimus", "synonyms": [ "AY 22-989", "AY 22989", "Rapamune", "Rapamycin", "I2190A", "I-2190A", "Sirolimus", "Fyarro", "I 2190A", "Sirolimusum", "Sirolim\u00fas", "AY 22 989", "(-)-Rapamycin", "Fyarro", "Sirolimus (with albumin)", "Fyarro", "Sirolimus (with albumin)" ], "medline_plus_id": "a602026", "generic_names": [ "Sirolimus", "Sirolimus (with albumin)", "Sirolimus (with albumin)" ], "mesh_id": "D007166", "drugbank_id": "DB00877", "wikipedia_url": "https://en.wikipedia.org/wiki/Sirolimus" } ] }

NCT02691273

Applicability of Cellular Application in Diabetes Type 2 Patients.

https://clinicaltrials.gov/study/NCT02691273

COMPLETED

It was found that an important part of the factors impeding adherence to medication and a healthy lifestyle among the chronically ill diabetic patients lies in proper management of the disease. Since it is a chronic progressive disease the caregiver is the patient himself.Studies have shown that software system, sending text messages / messages / reminders daily and answering questionnaires can improve adherence to a change in lifestyle. This study is an initial pilot study , which examines Feasibility ( Applicability ) of using a smart application that promotes a healthy lifestyle perseverance parallel use relaxation techniques .

NO

Diabetes Mellitus, Type 2

BEHAVIORAL: cellular application treating diabetes using breathing technique

10 percentage improvement in the quality of life questionnaire, two months

Hadassah Medical Organization

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

NM01-HMO-CTIL

2015-03

2017-03

2017-07

2016-02-25

2017-11-28

Hadassah Medical Organization, Jerusalem, 9112-, Israel

{ "cellular application treating diabetes using breathing technique": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05761873

Letters in Addition to Emailed Audit and Feedback in Refining Asthma Treatment in Primary Care

https://clinicaltrials.gov/study/NCT05761873

CLEARAIR

ACTIVE_NOT_RECRUITING

Public Health England have estimated that 36,000 excess deaths occur each year due to UK air pollution. Respiratory inhalers produce 3% of NHS greenhouse gas production. The two main inhaler device categories are pressurised Metered Dose Inhalers (pMDIs) and Dry Powder Inhalers (DPIs). The chemical propellant in pMDIs is the majority cause of inhaler carbon footprint, with pMDIs having an 18 times higher carbon footprint than DPIs. The rates of asthma in the UK population are amongst the highest worldwide and its mortality rate remains amongst the worst in Europe. A pre-existing Audit and Feedback (A&F) quality improvement project (QIP) is being undertaken by NHS West Yorkshire Integrated Care Board (ICB) with the aim of improving asthma outcomes and reducing the environmental impact of inhalers in primary care. The A&F being utilised here has been validated locally in two peer reviewed studies and is now standard practice in the region. There is convincing evidence that A&F has a positive effect on enacting behaviour change, especially where behaviour change is related to prescribing with low baseline compliance with guidelines. However, the evidence base is poor on which design features of A&F produce enhanced results. There is supporting evidence from local studies suggesting that posted paper A&F may be more effective at producing behaviour change than emailed copies of A&F alone. This study seeks to randomise the primary care practices within the pre-arranged QIP, to receive either a paper and emailed A&F report bimonthly for the duration of the study period, or to receive an emailed A&F report alone. The primary outcome of the study would be a comparison of the number of low-global warming potential inhalers prescribed as a percentage of the total prescribed inhalers from each intervention group.

NO

Asthma

OTHER: Provision of audit and feedback via email and paper|OTHER: Provision of audit and feedback via paper only

Low-global warming potential DPI inhalers use, The number of low-global warming potential DPI inhalers prescribed as a percentage of the total prescribed inhalers from each primary care practice - limited to those aged over 5, 1 year

6 or more SABA s prescriptions, Total number of patients with 6 or more SABA s prescription issues per a year in the last 12 months, 1 year|12 or more SABA s prescriptions, Total number of patients with 12 or more SABA s prescription issues per a year in the last 12 months, 1 year|3 or less inhaled corticosteroids prescriptions, Total number of patients with 3 or less inhaled corticosteroids prescription issues in the last 12 months, 1 year|2 or more courses of oral prednisolone prescriptions, Total number of patients with 2 or more courses of oral prednisolone prescription issues in the last 12 months?, 1 year|Children with second-hand smoke status recorded, Percentage of patients aged between 6-19 with asthma, with second-hand smoke status recorded, 1 year|Combination prescriptions of salbutamol MDIs with DPI preventers, Patients prescribed a combination of salbutamol MDIs with DPI preventers, 1 year|Prescriptions of non-salbutamol MDI s Vs DPIs prescribed in over 12s, Percentage of non-salbutamol MDI s Vs DPIs prescribed in over 12s, 1 year

University of Leeds

NHS West Yorkshire Integrated Care Board

ALL

CHILD, ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

CLEARAIR321442

2023-04-24

2024-05-17

2025-04-17

2023-03-09

2024-05-08

White Rose House, Wakefield, West Yorkshire, WF1 1LT, United Kingdom

{ "Provision of audit and feedback via email and paper": [ { "intervention_type": "OTHER" } ], "Provision of audit and feedback via paper only": [ { "intervention_type": "OTHER" } ] }

NCT05062473

Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem

https://clinicaltrials.gov/study/NCT05062473

WITHDRAWN

The purpose of this study is to test the feasibility of creating a health education telemedicine curriculum that can be delivered by Weill Cornell Medicine faculty and medical students and NY-Presbyterian Hospital resident physicians to community dwelling adults in an under-resourced local community.

NO

Hypertension

BEHAVIORAL: Lifestyle Modification Webinars Focused on Hypertension Control

Participant s Satisfaction with the Curriculum at 12 Weeks, Participant s satisfaction with the curriculum will be measured via 5-point Likert scale survey that was created by our research team. Scores will range from a low of Strongly disagree to a high of Strongly agree. , Week 12|Change in Number of Participants Virtually Attending the Health Education Seminars, Virtual attendance to the health education seminars will be collected. The number of participants who virtually attend all health education seminars over the 12 week period will be collected and change in number of participants attending will be assessed., Baseline to 12 weeks.|Change in Participant s Rate of Completion of Weekly Blood Pressure Recordings, Participant s rate of completion of the weekly blood pressure recording logs will be measured and analyzed., Baseline to 12 weeks.|Change in Participant s Rate of Completion of Weekly Steps Recordings, Participant s rate of completion of the weekly step recording logs will be measured and analyzed., Baseline to 12 weeks.

Mean Change in Systolic Blood Pressure Measurement., Participants will self-report weekly up to 4 blood pressure readings taken at baseline through week 12 with their automatic blood pressure arm cuff. The change in systolic blood pressure measurements in this time frame will be assessed., Baseline to week 12|Mean Change in Diastolic Blood Pressure Measurement., Participants will self-report weekly up to 4 blood pressure readings taken at baseline through week 12 with their automatic blood pressure arm cuff. The change in diastolic blood pressure measurements in this time frame will be assessed., Baseline to week 12|Mean Change in Number of Daily Steps Measured by Pedometer., Participants will self-report weekly the number of steps taken as measured by their wrist pedometer at baseline through week 12., Baseline to week 12|Change in Self-Reported Health Attitudes and Behaviors As Assessed by Survey., The name of the survey is Knowledge, attitudes, and perceptions towards hypertension and cardiovascular disease. The survey was adapted from the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System. It consists of both quantitative and qualitative questions assessing participants demographics, participants knowledge and attitudes about diet and exercise, and participants knowledge about hypertension and other related cardiac diseases (i.e. stroke, coronary artery disease). The survey will be administered at enrollment and post-intervention at week 12. Pre- and post-surveys will be compared for accuracy of answers and change in self-reported behaviors., Baseline, week 12

Weill Medical College of Cornell University

Health Resources and Services Administration (HRSA)

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

20-10022836|1 T1NHP391850100.

2021-10-04

2023-03-01

2023-03-01

2021-09-30

2023-11-01

Weill Cornell Medicine, New York, New York, 10021, United States

{ "Lifestyle Modification Webinars Focused on Hypertension Control": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT05453773

Hookah Additive Research to Inform Product Standards

https://clinicaltrials.gov/study/NCT05453773

HARPS

COMPLETED

This clinical trial evaluates how the content of waterpipe (WP) tobacco affects the appeal, puffing behavior, and toxicity of WP tobacco smoking. The data from the proposed study will provide direct links between WP tobacco s primary additives (sugars and humectants), CO and nicotine biomarkers, smoker preferences, perceptions of harm and puffing behaviors, and the subsequent range of toxicant exposures associated with these additives and behaviors. Study outcomes include waterpipe puffing behaviors, exhaled carbon monoxide levels, nicotine uptake, spirometry, sensory perceptions, smoking appeal, and risk perception. Waterpipe tobacco smoking is often the first combustible tobacco product tried by adolescents and young adults, possibly due to the widespread availability of heavily sweetened waterpipe tobacco and the perception that waterpipe smoking is a safer alternative to cigarette smoking. However, waterpipe tobacco smoking is associated with lung disease, carbon monoxide poisoning, and precursor conditions for oral and other cancers in adolescents and young adults. There is currently little data available on how the primary additives (by weight) in waterpipe tobacco affect puffing behaviors, toxicant exposures, pulmonary function and appeal. This clinical trial uses established waterpipe tobacco smokers, four investigational tobacco products with precisely manipulated levels of humectants and natural sugars in a single-blind, crossover (repeated measures) study design to determine how waterpipe tobacco additives effect human puffing behavior, nicotine uptake, flavor perceptions, lung function, and biomarkers of exposure.

NO

Tobacco-Related Carcinoma

OTHER: Questionnaire Administration|BEHAVIORAL: Tobacco Smoking

Change in Exhaled breath carbon monoxide (CO), Assessing change from baseline (boost): collect before and immediately after each smoking session with a handheld electrochemical cell. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in Plasma nicotine boost, Assessing change from baseline (boost): Whole blood collected before and immediately after each smoking session, separated, and plasma layer transferred and stored at -80 °C until analysis for nicotine according to validated methods using LC-MS/MS., Up to 2 years|Change in Forced vital capacity (FVC), Spirometer measurements will be collected. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in Forced expiratory volume in 1 second (FEV1), Spirometer measurements will be collected. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in FEV1/FVC; The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs., Spirometer measurements will be collected. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in Peak expiratory flow (PEF), Spirometer measurements will be collected. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in Forced expiratory flow at 25-75% of FVC, Spirometer measurements will be collected. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Tobacco use history, Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Nicotine dependence, Assessed by Hooked on Nicotine Checklist (HONC). 10 Yes or No questions, yes = 1, no = 0; minimum score = 0, maximum score = 10, higher scores mean greater nicotine dependence. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Nicotine dependence, Lebanese Waterpipe Dependence Scale (LWDS). Ten questions, min score = 0, max score = 36, higher sores mean greater nicotine dependence. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|General harm and specific health risk perceptions, Assessed using harm/health risk perceptions questionnaire. Min scale = 0 (no harm), max scale = 10 (extreme harm). Higher scores mean greater perceived harm/health risk. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Subjective effects of smoking tobacco, Assessed using Direct Effects of Tobacco scale. Min scale = 0 (not at all), Max scale = extremely. Higher number total means tobacco has greater effect. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in Subjective effects of smoking tobacco, Assessed change from baseline using Direct Effects of Nicotine scale. Min scale = 0 (not at all), Max scale = 100 (extremely). Higher number means nicotine has greater effect. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in Subjective effects of smoking tobacco, Assessed change from baseline using Questionnaire for Urges to Smoke. Min scale: 1 (strongly disagree), Max scale = 6 (strongly agree). Higher number means greater urge to smoke. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Change in Nicotine withdrawal assessment, Assessed change from baseline using Waterpipe-modified Minnesota Withdrawal Scale. Min scale = 0 (not at all), Max scale = 100 (extremely). Higher number total means greater withdrawal symptoms. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Tobacco flavors perception, intensity of sweetness, To determine the relative intensity of specific flavors, e.g., sweetness, will use the general version of the Labeled Magnitude Scale (gLMS), to obtain data that would permit ratio comparisons of perceived sensation magnitudes. Min scale = 0, Max scale = 100. Higher number means perception is stronger., Up to 2 years|Tobacco flavors perception, degree of liking or disliking, To assess the degree of liking or disliking of flavors, will use the Labeled Hedonic Scale (LHS) to collect ratio-level data on the magnitude of liking and disliking of sensation. Min scale = 0, Max scale = 100. Higher number means greater liking., Up to 2 years|Puffing topography, Puff volume will be measured continuously during the smoking session using the research-grade waterpipe. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Puffing topography, Puff duration will be measured continuously during the smoking session using the research-grade waterpipe. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Puffing topography, Puff average flow rate will be measured continuously during the smoking session using the research-grade waterpipe. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Puffing topography, Puff peak flow rate will be measured continuously during the smoking session using the research-grade waterpipe. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years|Puffing topography, Interpuff interval will be measured continuously during the smoking session using the research-grade waterpipe. Data will be analyzed using linear mixed models containing random subject effects. Since linear mixed models allow for incomplete data, data from all completed smoking sessions will be used in the analysis. Tukey s method will be used to adjust for multiple comparisons of the tobacco treatments., Up to 2 years

Ohio State University Comprehensive Cancer Center

Ohio State University|National Cancer Institute (NCI)|Food and Drug Administration (FDA)

ALL

ADULT

OTHER

INTERVENTIONAL

Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: OTHER

OSU-22158|NCI-2022-05156|R01CA255563

2022-06-19

2023-05-11

2023-05-11

2022-07-12

2023-11-30

Ohio State University Comprehensive Cancer Center, Columbus, Ohio, 43210, United States

{ "Questionnaire Administration": [ { "intervention_type": "OTHER" } ], "Tobacco Smoking": [ { "intervention_type": "BEHAVIORAL" } ] }

NCT00660673

Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson s Disease

https://clinicaltrials.gov/study/NCT00660673

COMPLETED

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study S187.3.004 [NCT00335153]).

YES

Advanced Parkinson s Disease

DRUG: Levodopa-Carbidopa Intestinal Gel (LCIG)|DEVICE: CADD-Legacy® 1400 ambulatory infusion pump|DEVICE: Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

Number of Participants With Treatment-emergent Adverse Events, Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a Possible or Probable or missing relationship to study drug. Serious AEs included any untoward medical occurrence that: * Resulted in death * Was life-threatening * Required inpatient hospitalization or prolongation of an existing hospitalization * Resulted in persistent or significant disability/incapacity * was a congenital anomaly/birth defect The severity of all AEs was characterized as mild, moderate or severe according to the following definitions: * Mild: usually transient and do not interfere with daily activities. * Moderate: low level of inconvenience or concern to the subject, may interfere with daily activities. * Severe: events interrupt the subject s usual daily activity., From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).

Number of Participants With Device Complications, Device complications include complications with the pump, intestinal tube, PEG-J or stoma., From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days.|Number of Participants With Sleep Attacks, Participants were asked whether they experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness. If yes, participants were asked if they suffered any bad outcome or problem from the falling asleep event., Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.|Number of Participants With Intense Impulsive Behavior, To monitor for the development of intense impulsive behavior the Minnesota Impulsive Disorder Interview (MIDI) was administered. The MIDI is a semi-structured clinical interview assessing pathological gambling, trichotillomania, kleptomania, pyromania, intermittent explosive disorder, compulsive buying, and compulsive sexual behavior., Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.|Number of Participants Who Developed Melanoma, A comprehensive assessment for the presence of melanoma was performed at least once a year by a dermatologist., Once per year during the study; median duration of treatment was 1178 days.|Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI), Adverse events of special interest (AESIs) were identified using standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (SMQ) or company MedDRA queries (CMQs). The AESI in the following categories were identified on the basis of review of the clinical program and postmarketing observations where the treatment system is commercially available. * Procedure and device associated events * Polyneuropathy, included preferred terms in either the peripheral neuropathy or GuillainBarre syndrome standardized MedDRA query (narrow search), such as polyneuropathy, decreased vibratory sense, peripheral neuropathy, peripheral sensory neuropathy, neuralgia, demyelinating polyneuropathy, and sensory disturbance * Weight loss * Cardiovascular fatalities * Respiratory tract aspiration including aspiration pneumonia/pneumonitis., From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).|Number of Participants With Any Suicidal Ideation or Behavior, The Columbia-Suicide Severity Rating Scale (C-SSRS) was implemented with Protocol Amendment 3 (20 March 2012) in order to assess suicidal behavior and ideation. Suicidal ideation includes the wish to be dead, nonspecific active suicidal thoughts, active ideation without intent to act, active ideation with some intent to act, and active ideation with specific plan or intent. Suicidal behavior includes actual attempts, interrupted attempts, aborted attempts, completed suicide, and preparatory acts or behaviors. The number of participants with affirmative responses on the C-SSRS at any time during the treatment period is reported., Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days.|Number of Participants With Potentially Clinically Significant Vital Sign Values, A vital sign value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant s corresponding Baseline value., Baseline and every 6 months until final visit; median duration of treatment was 1178 days.|Number of Participants With Potentially Clinically Significant Hematology Laboratory Values, A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant s corresponding Baseline value., Baseline and every 6 months until final visit; median duration of treatment was 1178 days.|Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values, A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant s corresponding baseline value. ULN = upper limit of normal, Baseline and every 6 months until final visit; median duration of treatment was 1178 days.|Number of Participants With Vitamin Levels Outside of the Normal Range, Special tests for vitamin deficiencies (folic acid, vitamin B6, vitamin B12, methylmalonic acid [MMA], and homocysteine) were implemented with Protocol Amendment 2 (27 July 2011). The number of participants with vitamin levels outside of the normal range at any time post-baseline is reported for each vitamin tested., Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days.|Number of Participants Receiving Concomitant Anti-Parkinson s Disease Medications by Treatment Year, Participants could use oral levodopa-carbidopa for scheduled or supplemental bedtime/overnight doses after the pump was disconnected for the night, or as rescue medication in case of acute deterioration caused by failure of the LCIG system such as tubes and/or the pump or the onset of an acute illness. The initiation of additional concomitant PD medication was allowed at the discretion of the Investigator if medically indicated., Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years).|Change in Average Daily Off Time Based on the Parkinson s Disease Symptom Diary at End of Treatment, The PD symptom diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, off , on without dyskinesia, on with non-troublesome dyskinesia, or on with troublesome dyskinesia. Off time was defined as time when medication had worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A negative change for off time indicates improvement. The PD diary assessment was implemented with Protocol amendment 4 (December 2013) for participants at United States (US) sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Average Daily On Time Without Troublesome Dyskinesia Based on the Parkinson s Disease Symptom Diary at End of Treatment, The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, off , on without dyskinesia, on with non-troublesome dyskinesia, or on with troublesome dyskinesia. On time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during on time. Non-troublesome dyskinesia does not interfere with function or cause meaningful discomfort. On time without troublesome dyskinesia is the sum of on time without dyskinesia and on time with non-troublesome dyskinesia. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Average Daily On Time With Troublesome Dyskinesia Based on the Parkinson s Disease Symptom Diary at End of Treatment, The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, off , on without dyskinesia, on with non-troublesome dyskinesia, or on with troublesome dyskinesia. On time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during on time. Troublesome dyskinesia interferes with function or causes meaningful discomfort. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Unified Parkinson s Disease Rating Scale (UPDRS) Part I Score at End of Treatment, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Unified Parkinson s Disease Rating Scale (UPDRS) Part II Score at End of Treatment, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Unified Parkinson s Disease Rating Scale (UPDRS) Part III Score at End of Treatment, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). UPDRS Part III consists of 14 questions. Questions 20 - 26 are multi-part questions in that they are evaluated separately for multiple body parts. Counting each of these assessments leads to a total of 27 answers for Part III. The UPDRS Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-Point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Unified Parkinson s Disease Rating Scale (UPDRS) Total Score at End of Treatment, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The UPDRS total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I - III of the scale. The total score ranges from 0 - 176 with 176 representing the worst (total) disability, and 0 no disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Unified Parkinson s Disease Rating Scale (UPDRS) Part IV Score at End of Treatment, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias). The UPDRS Part IV Score is the sum of all answers to the 11 questions that comprise Part IV, 4 of which are measured on a 5-point scale (0 - 4) and 7 which are measured on a 2-point scale (0 - 1). The Part IV score ranges from 0 - 23 with higher scores associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Unified Parkinson s Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment, The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias); and The UPDRS Part IV dyskinesia Score is the sum of Questions 32 (What proportion of the waking day are dyskinesias present?), 33 (How disabling are the dyskinesias? ), and 34 (How painful are the dyskinesias?) on UPDRS Part IV, each of which are measured on a 5-point scale (0-4). The Part IV dyskinesia score ranges from 0 - 12 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.|Change in Parkinson s Disease Questionnaire (PDQ-39) Scores at End of Treatment, The PDQ-39 is a self-administered questionnaire that comprises 39 items addressing the following eight domains of health that patients consider to be adversely affected by the disease: * Mobility (e.g., fear of falling when walking) - 10 questions * Activities of daily living (e.g., difficulty cutting food) - 6 questions * Emotional well-being (e.g., feelings of isolation) - 6 questions * Stigma (e.g., social embarrassment) - 4 questions * Social support - 3 questions * Cognition - 4 questions * Communication - 3 questions * Bodily discomfort - 3 questions Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness. The PDQ-39 summary index (range 0-100) includes responses to all 39 items. A negative change indicates improvement., Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

AbbVie

IQVIA, formerly Quintiles

ADULT, OLDER_ADULT

PHASE3

INDUSTRY

INTERVENTIONAL

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

S187.3.005|2008-001329-33

2009-11-13

2021-11-30

2021-11-30

2008-04-17

2022-12-02

2022-12-02

University of Alabama at Birmingham /ID# 49941, Birmingham, Alabama, 35294, United States|The Research Center of Southern California /ID# 49928, Encinitas, California, 92024, United States|The Parkinson s & Movement Disorder Institute - Fountain Valley /ID# 49915, Fountain Valley, California, 92708, United States|Universtiy of Southern California /ID# 49913, Los Angeles, California, 90033, United States|Colorado Neurological Institute /ID# 49927, Englewood, Colorado, 80113, United States|Georgetown University Hospital /ID# 49931, Washington, District of Columbia, 20007, United States|Bradenton Research Center, Inc /ID# 49929, Bradenton, Florida, 34205, United States|Neurologic Consultants, PA /ID# 49918, Fort Lauderdale, Florida, 33308, United States|University of Florida - Archer /ID# 49935, Gainesville, Florida, 32610, United States|University of Florida /ID# 49922, Jacksonville, Florida, 32209, United States|Charlotte Neurological Service /ID# 49916, Port Charlotte, Florida, 33980, United States|University of South Florida /ID# 49919, Tampa, Florida, 33612, United States|Georgia Regents University /ID# 49938, Augusta, Georgia, 30912, United States|Northwestern University Feinberg School of Medicine /ID# 49944, Chicago, Illinois, 60611-2927, United States|Rush University Medical Center /ID# 49930, Chicago, Illinois, 60612, United States|University of Kentucky Chandler Medical Center /ID# 49940, Lexington, Kentucky, 40536, United States|Louisiana State Univ HSC /ID# 49945, Shreveport, Louisiana, 71130, United States|Univ Maryland School Medicine /ID# 49934, Baltimore, Maryland, 21201, United States|Johns Hopkins University /ID# 49937, Baltimore, Maryland, 21287, United States|Washington University-School of Medicine /ID# 49933, Saint Louis, Missouri, 63110, United States|University of Nebraska Medical Center /ID# 49911, Omaha, Nebraska, 68198, United States|North Shore University Hospital /ID# 49932, Manhasset, New York, 11030, United States|The Mount Sinai Hospital /ID# 49942, New York, New York, 10029, United States|Columbia Univ Medical Center /ID# 49943, New York, New York, 10032-3725, United States|Raleigh Neurology Associates /ID# 49923, Raleigh, North Carolina, 27607, United States|Wake Forest Univ HS /ID# 49939, Winston-Salem, North Carolina, 27157, United States|University of Cincinnati /ID# 49914, Cincinnati, Ohio, 45267-0585, United States|Cleveland Clinic Main Campus /ID# 76173, Cleveland, Ohio, 44195, United States|University of Vermont Medical Center /ID# 49912, Burlington, Vermont, 05401-1473, United States|King County Public Hospital /ID# 49917, Kirkland, Washington, 98034, United States|Froedtert Memorial Lutheran Hospital /ID# 49924, Milwaukee, Wisconsin, 53226, United States|Westmead Hospital /ID# 50081, Westmead, New South Wales, 2145, Australia|Royal Adelaide Hospital /ID# 50083, Adelaide, South Australia, 5000, Australia|Austin Hospital /ID# 50082, Heidelberg, Victoria, 3084, Australia|University of Alberta /ID# 78476, Edmonton, Alberta, T6G 2B7, Canada|Toronto Western Hospital /ID# 75913, Toronto, Ontario, M5T 2S8, Canada|CHUM - Notre-Dame Hospital /ID# 74513, Montréal, Quebec, H2X 0A9, Canada|Fakultni Nemocnice u Svate Anny /ID# 50085, Brno, 656 91, Czechia|Fakultni nemocnice Hradec Kralove /ID# 50088, Hradec Králové, 500 05, Czechia|Pardubicka krajska nemocnice, a.s., Pardubice, 532 03, Czechia|Vseobecna fakultni nemocnice v Praze /ID# 50086, Praha, 128 21, Czechia|Fakultni Nemocnice v Motole /ID# 50084, Praha, 150 06, Czechia|Tel Aviv Sourasky Medical Center /ID# 50089, Tel-Aviv, 64239, Israel|Waikato Hospital /ID# 50091, Hamilton, Waikato, 3240, New Zealand|Auckland City Hospital /ID# 50093, Auckland, 1023, New Zealand|New Zealand Brain Research Institute/ID# 50090, Christchurch, 8011, New Zealand|Wellington Hospital /ID# 50092, Wellington, 6021, New Zealand|Miejskie Centrum Medyczne im. dr. Karola Jonschera w Lodzi /ID# 50096, Łódź, Lodzkie, 93-113, Poland|NZOZ Centrum Medyczne HCP /ID# 50094, Poznań, Wielkopolskie, 61-485, Poland|Hospitais da Universidade de Coimbra /ID# 50098, Coimbra, 3000-075, Portugal|Hospital de Santa Maria /ID# 50099, Lisboa, 1649-035, Portugal|Centro Hospitalar Universitario de Sao Joao, EPE /ID# 50101, Porto, 4200-319, Portugal|Scientific Research Medical Complex Your Health /ID# 50104, Kazan, 420097, Russian Federation|Institution of the Russian Academy of Medical Sciences Scientific Centre of Neurology /ID# 50102, Moscow, 125367, Russian Federation|Military Medical Academy n.a. Kirov /ID# 50103, Saint Petersburg, 194044, Russian Federation|I.P. Pavlov First St. Petersburg State Medical University /ID# 50107, Saint Petersburg, 197022, Russian Federation|City Clinical Hospital #40 /ID# 50106, Saint Petersburg, 197706, Russian Federation|King Chulalongkorn Mem Hosp /ID# 50108, Bangkok, 10330, Thailand|Siriraj Hospital /ID# 50109, Bangkok, 10700, Thailand|The Walton Centre NHS Foundation /ID# 50003, Liverpool, L9 7LJ, United Kingdom|National Hospital for Neurology & Neurosurgery, London, WC1N 3BG, United Kingdom

Study Protocol, https://cdn.clinicaltrials.gov/large-docs/73/NCT00660673/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/73/NCT00660673/SAP_001.pdf

{ "Levodopa-Carbidopa Intestinal Gel (LCIG)": [ { "intervention_type": "DRUG" } ], "CADD-Legacy\u00ae 1400 ambulatory infusion pump": [ { "intervention_type": "DEVICE" } ], "Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)": [ { "intervention_type": "DEVICE" } ] }

NCT04472273

Comparison of High-Flow Nasal Cannula Oxygen Application and Classic Nasal Cannula Oxygen Application

https://clinicaltrials.gov/study/NCT04472273

UNKNOWN

Recently, sedation practices have increased for diagnostic and interventional procedures for children in non-operating rooms. On the other hand, the rate of respiratory complications especially in non-operating room sedation applications is quite high. Oxygen therapy in sedation applied to non-operating room endoscopy patients is mostly performed with classical nasal cannula. However, recently, the use of High-flow nasal cannula oxygen therapy has been increasing. According to the classical nasal cannula oxygen therapy application where non-moistened oxygen is applied in high-flow nasal cannula oxygen therapy applications where heated and humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L / min. This method has many advantages. Some of those; makes it possible to provide high flows easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing a decrease in anatomical dead space. It provides discharge of expired air in the upper airways. It reduces the respiration of gas with high CO2 and decreased O2. It increases alveolar ventilation. It is easy to use and increases patient comfort. It offers a stream adjusted to all children. Flow and titration can be adjusted according to the child s weight and effect. Physiological evidence in the pediatric population indicates that flows equal to or higher than 2 L / kg / min produce clinically significant pharyngeal pressure, improve breathing and accelerate the emptying of the respiratory muscles. Because of all these features, high-flow nasal cannula oxygen therapy application is used safely in pediatric patients. In general, it is reported that in non-operating room anesthesia, sedation or anesthesia applied in pediatric patients causes undesirable effects by 20%, most of them (5.5%) have respiratory complications and bradycardia due to hypoxemia. In this study, we aimed to compare the respiratory and hemodynamic results of high-flow nasal cannula oxygen application, which is routinely used in sedation applications in the pediatric endoscopy unit of our hospital, with the classical nasal cannula oxygen therapy application.

NO

Sedation Complication

PROCEDURE: high-flow nasal cannula / classic nasal cannula

Comparison of the effects of high-flow nasal cannula oxygen administration and nasal cannula oxygen administration on respiratory parameters in patients undergoing sedation in the pediatric endoscopy unit., SpO2 and ETCO2 are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications., SpO2 values of patients at admission, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded. After the procedure, SpO2 and ETCO2 values at the input, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded.

Comparison of the effects of high flow nasal cannula oxygen administration and nasal cannula oxygen administration on hemodynamic parameters in patients undergoing sedation in the pediatric endoscopy unit., HR and blood pressure (both systolic and diastolic blood pressure) are recorded as data in patients in high-flow nasal cannula and classical nasal cannula oxygen therapy applications., HR and blood pressure values of patients at admission, 1 minute, 5 minutes, 10 minutes 15 minutes and 20 minutes will be recorded. After the procedure, HR values at the input, 1 minute, 5 minutes, 10 minutes, 15 minutes and 20 minutes will be recorded.

Kocaeli Derince Education and Research Hospital

ALL

CHILD, ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

U1111-1253-6757

2020-02-27

2020-10

2021-02

2020-07-15

2020-07-15

Sami Olcay OZBAY, Kocaeli, Turkey

{ "high-flow nasal cannula / classic nasal cannula": [ { "intervention_type": "PROCEDURE" } ] }

NCT04876573

Pilot Study for Cyproheptadine in Hospitalized Patient for COVID-19

https://clinicaltrials.gov/study/NCT04876573

UNKNOWN

This is a Pilot study for evaluating the feasibility, security and efficacy of the use of Cypropheptadine, an antihistaminic and antiserotonin drug, as an adjunct of the standardized treatment in a population of patient who are hospitalized and requiring oxygen therapy for COVID-19.

NO

Viral Pneumonia|COVID-19 Pneumonia|Serotonin Syndrome|Platelet Dysfunction

DRUG: Cyproheptadine Hydrochloride 4 MG

Clinical evolution according the WHO Clinical Progression Scale, World Health Organisation Clinical Progression Scale for COVID 19 Minimal value 0 (uninfected) to maximal value 10 (Dead), Approximately 28 days

Incidence of Treatment-Emergent Adverse Events, Safety evaluation, as measured by suspected as related to cyproheptadine during the first 28 days after inclusion in the study: Adverse events Adverse drug reactions Serious adverse event and adverse drug reaction, Approximately 28 days|Recruitement rate, 6 month|Completion rate, 6 month|Rate of Death from any cause, Approximately 28 days|Total number of days of hospitalisation, Approximately 28 days|Total number of days of hospitalization in the ICU, Approximately 28 days|Total number of days of mechanical ventilation, Approximately 28 days|Daily ROX ratio, Worst value of ROX ratio (SPO2/FiO2/Respiratory Rate) at D3,5,7,10,14,28, Approximately 28 days|Creatinine level, Worst value of Laboratory assessment of Creatinine at Days 3,5,7,10,14,28 after inclusion in the study, Approximately 28 days|Alanine amino transferase level, Worst value of Laboratory assessment of Alanine amino transferase at Days 3,5,7,10,14,28 after inclusion in the study, Approximately 28 days|C Reactive Protein level, Worst value of Laboratory assessment of CRP at Days 3,5,7,10,14,28 after inclusion in the study, Approximately 28 days|D-Dimere level, Worst value of Laboratory assessment of D-Dimere at Days 3,5,7,10,14,28 after inclusion in the study, Approximately 28 days|Platelet count, Worst value of Laboratory assessment of platelet count at Days 3,5,7,10,14,28 after inclusion in the study, Approximately 28 days

Ciusss de L Est de l Île de Montréal

ALL

ADULT, OLDER_ADULT

PHASE2

OTHER

INTERVENTIONAL

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

2022-2669

2021-06-01

2021-12-31

2022-01-31

2021-05-06

2021-05-06

{ "Cyproheptadine": [ { "intervention_type": "DRUG", "description": "Cyproheptadine Hydrochloride 4 MG", "name": "Cyproheptadine", "synonyms": [ "Periactin", "Ciproheptadina", "Viternum", "Peritol", "5-(1-methylpiperidylidene-4)-5H-dibenzo(a,d)cyclopheptene", "1-methyl-4-(5-dibenzo(a,e)cycloheptatrienylidene)piperidine", "1-Methyl-4-(5H-dibenzo(a,d)cycloheptenylidene)piperidine", "Cyproheptadine", "Cyproheptadinum", "Dihexazin", "Cyproheptadin", "4-Dibenzo[a,d]cyclohepten-5-ylidene-1-methyl-piperidine", "4-(5-dibenzo(a,d)cyclohepten-5-ylidine)-1-methylpiperidine", "Antergan", "4-(5H-dibenzo(a,d)cyclohepten-5-ylidene)-1-methylpiperidine" ], "medline_plus_id": "a682541", "generic_names": [ "Cyproheptadine" ], "mesh_id": "D018926", "drugbank_id": "DB00434" } ], "Mianserin": [ { "intervention_type": "DRUG", "description": "Cyproheptadine Hydrochloride 4 MG", "name": "Mianserin", "synonyms": [ "Mianserin", "Mianserine", "Mians\u00e9rine", "Mianserina", "Hydrochloride", "Monohydrochloride, Mianserin", "Mianserin Monohydrochloride", "Mianserinum", "Tolvon", "Lerivon", "1,2,3,4,10,14b-Hexahydro-2-methyldibenzo(c,f)pyrazino(1,2-a)azepine", "Mianseryna", "Org GB 94", "Hydrochloride, Mianserin", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum", "Procaterol Monohydrochloride", "CI 888", "Procaterol Monohydrochloride, (R*,R*)-(-)-Isomer", "Hydrochloride", "Monohydrochloride, Procaterol", "Procaterol, (R*,R*)-(+-)-Isomer", "ProAir", "Pro Air", "Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+-)-Isomer", "Procaterol Monohydrochloride, (R*,S*)-(+)-Isomer", "Pro-Air", "Procaterol Monohydrochloride, (R*,S*)-(-)-Isomer", "Hydrochloride, Procaterol", "Procaterol Monohydrochloride, (R*,R*)-(+)-Isomer", "CI-888", "OPC-2009", "Procaterol, (R*,S*)-(-)-Isomer", "OPC2009", "(R*,S*)-(+-)-8-Hydroxy-5-(1-hydroxy-2-((1-methylethyl)amino)butyl)-2(1H)-quinolinone", "CI888", "OPC 2009", "Procaterolo", "Procaterolum" ], "mesh_id": "D018687", "generic_names": [ "Mianserin", "Procaterol", "Procaterol" ], "drugbank_id": "DB06148" } ] }

NCT03590873

The Effect of Restrictive Fluid and Vasopressin During Surgery of Burn Patients

https://clinicaltrials.gov/study/NCT03590873

UNKNOWN

This is a randomized double-blinded study to investigate in which the groups are designated as the control group and the restrictive group to further evaluate significant differences in intraoperative blood loos during burn surgery.

NO

Burn Surgery

DRUG: Vasopressin

Intraoperative blood loss, Comparison of the amounts of estimated blood loss in the two groups., At the end of the surgery, approximately 3 hrs

Intraoperative red blood cell transfusion, Comparison of total units of red blood cell transfusion in the two groups., At the end of the surgery, approximately 3 hrs|Postoperative pulmonary complication, Comparison of postoperative pulmonary complication in the two groups., Within 7 postoperative days|Postoperative cardiovascular complication, Comparison of postoperative cardiovascular complication in the two groups., Within 7 postoperative days|Postoperative renal complication, Comparison of postoperative acute kidney injury in the two groups., Within 7 postoperative days

Hangang Sacred Heart Hospital

Asan Medical Center

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

2018-051

2018-07-25

2019-06-04

2019-06-04

2018-07-18

2018-07-31

Hangang Sacred Heart Hospital, Seoul, 07247, Korea, Republic of

{ "Vasopressin": [ { "intervention_type": "DRUG", "description": "Vasopressin", "name": "Vasopressin", "synonyms": [ "Vasopressin, unspecified", "Vasopressin", "Vasopressina" ], "drugbank_id": "DB00067", "generic_names": [ "Vasopressin" ] } ] }

NCT04885673

High Flow Nasal Cannula in Comparison to Apneic Oxygenation During Foreign Body Removal by Rigid Bronchoscope

https://clinicaltrials.gov/study/NCT04885673

UNKNOWN

To compare the effect of HFNC with standard apneic oxygenation on patient oxygenation and airway protection during foreign body removal by rigid bronchoscope.

NO

Anesthesia

DEVICE: Vapotherm|DEVICE: Apneic oxygenation

Maintain high level of oxygen saturation during the procedure, Monitoring oxygen saturation by pulse oximeter and recording the readings, During the procedure time

Ain Shams University

ALL

CHILD, ADULT

OTHER

INTERVENTIONAL

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

FMASU R101/2021

2021-04-25

2021-07-05

2021-07-25

2021-05-13

2021-05-18

Samar Mohammed, Cairo, 11511, Egypt

{ "Vapotherm": [ { "intervention_type": "DEVICE" } ], "Apneic oxygenation": [ { "intervention_type": "DEVICE" } ] }

NCT04681573

Comparison of Two sTRAtegies For the Non-Invasive Diagnosis of advanCed Liver Fibrosis in NAFLD

https://clinicaltrials.gov/study/NCT04681573

TRAFIC

UNKNOWN

NAFLD, closely linked to overweight and insulin resistance, has reached 25% prevalence worldwide. Advanced liver fibrosis(ALF) must be accurately diagnosed in NAFLD because it defines a subgroup of patients with impaired prognosis, and these patients need a specific management to prevent the occurrence of liver-related complication. Relatively few NAFLD patients develop ALF and it is a challenge for physicians to identify them. Liver biopsy is the reference for liver fibrosis evaluation but this invasive procedure cannot be first-line used in NAFLD. Non-invasive diagnosis of liver fibrosis is now available, especially liver stiffness measurement (LSM) with Fibroscan and blood fibrosis tests. However, Fibroscan is a costly device available only in few specialized centres with thus poor accessibility in face of the large NAFLD population. Blood fibrosis tests can be performed by every physician and are distinguished as complex or simple . Because they include specialized biomarkers, complex blood fibrosis tests are accurate for the diagnosis of ALF but they are quite expensive and not reimbursed, with therefore limited use in clinical practice. Simple blood fibrosis tests have the advantage to include cheap and easy-to-obtain biomarkers with simple calculation thanks to free websites or smartphone applications. Simple blood fibrosis tests are globally less accurate than complex blood fibrosis tests or Fibroscan but, used with a high-sensitivity cut-off, they have the high interest of being able to accurately rule out advanced fibrosis in a significant proportion of NAFLD patients. Recently, two sequential diagnostic procedures have been developed for the diagnosis of ALF with the idea to combine the advantages of the different kind of fibrosis tests: the FIB4-Fibroscan (FIB4-FS) and the eLIFT-FibroMeterVCTE (eLIFT-FMVCTE) algorithms. These algorithms include as first-line procedure a simple blood fibrosis test (FIB4 or eLIFT) which identifies the patients who require a further second-line evaluation with a more accurate non-invasive test (Fibroscan or FibroMeterVCTE). Liver biopsy is finally used as third-line procedure in patients for whom the diagnosis remains undetermined. Such algorithms have the advantage to limit the use of complex fibrosis tests only to a subset of at risk-patients. The TRAFIC study compare two strategies for the diagnosis of ALF in NAFLD patients: the FIB4-Fibroscan algorithm and the eLIFT-FibroMeterVCTE algorithm

NO

NAFLD

DIAGNOSTIC_TEST: blood tests

Rate of patients correctly classified for advanced liver fibrosis, Rate of patients correctly classified for advanced liver fibrosis, with comparison between the FIB4-FS and eLIFT-FMVCTE algorithms, 2 months

Sensitivity for advanced fibrosis, Sensitivity for advanced fibrosis, with comparison between the FIB4-FS and eLIFT-FMVCTE algorithms, 2 months|Parameters influencing the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms, Parameters independently associated by multivariate analysis with the rate of patients correctly classified for advanced liver fibrosis, 2 months|Rate of patients correctly classified for advanced liver fibrosis as a function of the prevalence of advanced fibrosis, Rate of patients correctly classified for advanced liver fibrosis in samples generated by resampling methods with different prevalence of advanced fibrosis (5%, 10%, 15%, 20% and 25%), with comparison between FIB4-FS and eLIFT-FMVCTE algorithms, 2 months|Effect of the choice of the Fibroscan probe on the diagnostic accuracy of FIB4-FS and eLIFT-FMVCTE algorithms, Rate of patients correctly classified for advanced fibrosis by the algorithms calculated with either LSMAUTO results (i.e., LSM results obtained with the probe, M or XL, which is automatically detected and recommended by the Fibroscan device), or only LSMM results (i.e., LSM results obtained with the M probe), or only LSMXL results (i.e., LSM results obtained with the XL probe)., 2 months|To validate new biomarkers in a large independent NAFLD population, AUROC for advanced fibrosis, with comparison between the new biomarkers and existing fibrosis tests, 2 months

University Hospital, Angers

ALL

ADULT, OLDER_ADULT

OTHER_GOV

INTERVENTIONAL

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

2020-A01920-39

2021-03

2022-09

2022-11

2020-12-23

2020-12-23

{ "blood tests": [ { "intervention_type": "DIAGNOSTIC_TEST" } ] }

NCT06316973

A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants

https://clinicaltrials.gov/study/NCT06316973

RECRUITING

The purpose of this Phase 1a study is to evaluate safety, tolerability, and pharmacokinetics (PK) of single, ascending doses of CS-1103, administered by intravenous (IV) infusion in healthy participants.

NO

Substance Use Disorders|Methamphetamine Abuse|Methamphetamine Intoxication

DRUG: CS-1103|DRUG: Sterile Saline

Number of participants with treatment-related adverse events (AEs) assessed by physical examinations, Physical examinations, 3 days plus 8 day follow-up|Number of participants with treatment-related adverse events (AEs) assessed by vital signs, Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature, 3 days plus 8 day follow-up|Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs), Digital 12-lead electrocardiograms (ECGs). Any relationship between CS-1103 plasma concentrations and changes in QT intervals will be noted., 3 days plus 8 day follow-up|Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters, Clinical chemistry, hematology, coagulation, and urinalysis, 3 days plus 8 day follow-up

Time course of CS-1103 blood and urine concentrations, Measurement of plasma and urine concentrations of CS-1103, 48 hours

Clear Scientific, Inc.

National Institute on Drug Abuse (NIDA)

ALL

ADULT

PHASE1

INDUSTRY

INTERVENTIONAL

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

CS-1103-01|U01DA053054

2024-02-07

2024-07

2024-07

2024-03-19

2024-03-19

Dr. Vince Clinical Research, Overland Park, Kansas, 66212, United States

{ "CS-1103": [ { "intervention_type": "DRUG" } ], "Sterile Saline": [ { "intervention_type": "DRUG" } ] }

NCT03763773

Prediction of Outcomes With a Miniaturized Transesophageal Echocardiography Probe in Patients With Acute Respiratory Distress Syndrome

https://clinicaltrials.gov/study/NCT03763773

PreMiTE-ARDS

COMPLETED

The Superior Vena cava Respiratory Collapse Index (cVCS) is a haemodynamic parameter measured exclusively by transoesophageal ultrasound (TEE), which is used to assess cardiac precharge-dependence status. This may be an important prognostic factor in ARDS because it is a sign of hypervolemia and right heart failure.

NO

Acute Respiratory Distress Syndrome

Number of days lived without mechanical ventilation, This variable will be defined as follows:duration = 28 -x -y. where x is the number of days living under mechanical ventilation during the first 28 days and the number of days in the first 28 days., at 28 days

number of patient of death, At 28 days, at 90 days

University Hospital, Lille

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

2017_30|2018-A01463-52

2019-04-21

2021-04-20

2021-04-20

2018-12-04

2022-04-29

Hôpital Roger Salengro, CHU, Lille, France

{}

NCT06154473

Assessment of Patients Undergoing Cardiac Surgery and Admitted to the Intensive Care Unit

https://clinicaltrials.gov/study/NCT06154473

BraSIS-2

RECRUITING

The objective of this study is to investigate the incidence of death and early postoperative complications, identify potential risk factors, and examine the demographic characteristics of patients and epidemiology of cardiovascular procedures. Our hypothesis is that gaining a more comprehensive understanding of the characteristics of patients who undergo cardiac surgery has the potential to improve outcomes for this patient profile. Thus, information was sought regarding the patient characteristics, surgeries performed, anesthesia administered, incidence of intraoperative and postoperative complications, and risk factors associated with complication and mortality in the ICU. The main questions it aims to answer are: * Incidence of mortality or severe postoperative complications that occur within the first 3 postoperative days or until discharge from the ICU. * Risk factors associated with severe complications in patients who undergo cardiac surgery. * Characteristics of patients, anesthesia and surgical procedures performed * Incidence of severe intraoperative complications and moderate postoperative complications * Evaluate the influence of accumulated fluid balance on outcomes, mortality, and length of ICU stay. * Evaluate mortality in the ICU. * Describe the risk factors associated with mortality.

NO

Cardiac Disease|Cardiac Ischemia|Cardiac Valve Disease

PROCEDURE: Open heart surgery group.|PROCEDURE: Percutaneous cardiovascular surgery group.

Mortality or severe postoperative complications within the first 3 postoperative days or until ICU discharge, whichever occurs first, Severe postoperative complications are: stroke, septic shock, unscheduled urgent or emergency surgical reoperation, cardiovascular complications, hematological complications, pulmonary complications, and renal complications, Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

Evaluate the characteristics of the patients, Describe demographic characteristics of the patients, Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days|Describe the surgeries performed, Describe the type of surgeries performed. Description of the surgery as: emergency, urgent and elective surgery; open heart surgery or percutaneous cardiovascular surgery; valve repair (or replacement) and/or coronary artery bypass grafting, Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days|Describe the anesthesia performed, The following anesthesia modalities will be considered and collected: general anesthesia, combined general anesthesia (general anesthesia and neuroaxis block) and sedation, Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days|Evaluate the incidence of severe intraoperative complications, The following severe intraoperative complications will be considered and collected: bronchospasm or difficulty with respiratory support, failure to exit cardiopulmonary bypass (CPB), cardiac arrest with return of spontaneous circulation, and excessive blood transfusion (≥ 4 units of packed red blood cells), Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days|Assess the incidence of other postoperative complications (not included in the primary endpoint), The following postoperative complications will be considered and collect: cardiovascular; pulmonary; neurological, gastrointestinal and metabolic, Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days|Evaluate the influence of fluid balance on ICU mortality, Evaluate the influence of fluid balance on ICU mortality. Determine if the increase in fluid balance during the ICU stay is associated with the increase in ICU mortality., Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days|Assess the length of stay in the ICU, Calculated from the date and time of admission and date and time of actual ICU discharge (discharge or death), Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days|Evaluate the risk factors associated with ICU mortality, To construct a logistic regression model to identify risk factors associated with increased ICU mortality., Within the first 3 postoperative days or until ICU discharge, whichever occurs first, assessed up to 3 postoperative days

Hospital Israelita Albert Einstein

ALL

ADULT, OLDER_ADULT

OTHER

OBSERVATIONAL

Observational Model: |Time Perspective: p

5350-22

2023-09-01

2024-09

2024-11

2023-12-04

2023-12-04

Hospital Israelita Albert Einstein, São Paulo, Brazil

{ "Open heart surgery group.": [ { "intervention_type": "PROCEDURE" } ], "Percutaneous cardiovascular surgery group.": [ { "intervention_type": "PROCEDURE" } ] }

NCT03659773

Immune Response to Vaccinations in Hematopoietic Stem Cell Transplant Recipients

https://clinicaltrials.gov/study/NCT03659773

VaccHemInf

COMPLETED

Hematopoietic stem cell transplantation (HSCT) is a cellular therapy aiming at curing some hematological diseases. Upon transplantation, recipients experience a phase of profound immune suppression with loss of protective immunity against most infectious agents. Revaccination of HSCT recipients against vaccine-preventable infections is an important post-transplant intervention for reducing morbi-mortality. The VaccHemInf project aims at assessing the efficacy of recommended vaccines in adult recipients of HSCT, through the antibody titers reference method and a panel of immune functional assays.

NO

Vaccination|Hematopoietic Stem Cells

BIOLOGICAL: immune biomarkers to evaluate vaccine response in HSCT recipients

proportion of responders defined by the increase in specific antibody titers at 3 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV)., ELISA methods will be used to measure serum level concentrations of specific immunoglobulin G (IgG) antibodies to tetanus toxoid, diphtheria toxoid, Hib, pneumococcal capsular polysaccharides and HBV. For pneumococcus, a 4-fold increase in the IgG titer will be considered significant for immunization. For Hib, the values between 0.15-1 μg/mL will be significant for immunization (linearity limit of 9 μg/mL). An IgG titer equal or higher than 0.1 IU/mL for diphtheria and tetanus and higher than 10 mIU/mL for HBV (anti-HBs antibody titer will be considered protective) . An anti-HBs titer higher than 100 IU/mL will be considered to confer long-lasting protection., at 3 months after block vaccination

proportion of responders defined by the increase in specific antibody titers at 12 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV)., ELISA methods will be used to measure serum level concentrations of specific IgG antibodies to tetanus toxoid, diphtheria toxoid, Hib, pneumococcal capsular polysaccharides and HBV. For pneumococcus, a 4-fold increase in the IgG titer will be considered significant for immunization. For the Hib, the values between 0.15-1 μg/mL will be significant for immunization (linearity limit of 9 μg/mL). An IgG titer equal or higher than 0.1 IU/mL for diphtheria and tetanus and higher than 10 mIU/mL for HBV (anti-HBs antibody titer) will be considered protective. An anti-HBs titer higher than 100 IU/mL will be considered to confer long-lasting protection, at 12 months after block vaccination|proportion of responders defined by the increase in specific antibody titers at 24 months after full block vaccination including tetanus, diphtheria, Pneumococcus, Haemophilus influenza type B (Hib), and hepatitis B virus (HBV)., ELISA methods will be used to measure serum level concentrations of specific IgG antibodies to tetanus toxoid, diphtheria toxoid, Hib, pneumococcal capsular polysaccharides and HBV. For pneumococcus, a 4-fold increase in the IgG titer will be considered significant for immunization. For the Hib, the values between 0.15-1 μg/mL will be significant for immunization (linearity limit of 9 μg/mL). An IgG titer equal or higher than 0.1 IU/mL for diphtheria and tetanus and higher than 10 mIU/mL for HBV (anti-HBs antibody titer) will be considered protective. An anti-HBs titer higher than 100 IU/mL will be considered to confer long-lasting protection, at 24 months after block vaccination|Correlation between quantification of relevant immune cells of HSCT recipients and vaccine response, the association between blood T- B- and NK cell counts and subtypes of T and B cells (cells /mm3 of whole blood) and vaccine response will be analyzed, at 3, 12 and 24 months after full block vaccination|Correlation between proliferative T-cell response to mitogens and antigens and vaccine response, lymphocyte proliferation in response to ex vivo T cell stimulation (% of proliferating cells among CD3+ T-cells) will be evaluated The values measured will be defined as normal or abnormal, depending on whether they are within reference intervals (RI) derived from an independent set of healthy volunteers (REALISM protocol)., before and at 3 months after full block vaccination|Correlation between innate immune response after ex vivo whole blood stimulation and vaccine response, The production of tumor necrosis factor (TNF) alpha released by blood cells in response to ex vivo stimulation by lipopolysaccharide (in pg/mL) will be measured The values measured will be defined as normal or abnormal, depending on whether they are within reference intervals (RI) derived from an independent set of healthy volunteers (REALISM protocol)., before and at 3 months after full block vaccination|proportion of HSCT recipients with adverse event after each vaccination including local and general reactions, local and general reactions will be monitored for 30 min after each vaccination. Recipients will be given a diary card to record occurrence and severity of specific local reactions at the injection site and specific general reactions for 21 days after each vaccine injection., 21 days after each vaccination|ancillary study of cellular and humoral response to one dose of tetravalent inactivated influenza vaccine (IIV), Hemagglutination-inhibition assay (HAI) will be used to measure serum level concentrations of specific antibodies to the four influenza strains included in the vaccine. Immunization will be defined by seroprotective antibody titers ≥ 1:40 and/or seroconversion (4-fold rise in antibody titers). T-cell responses elicited by IIV will be measured ex vivo by interferon-Gamma ELISpot assay and expressed as number of spot-forming-cells. T-cell responses will be correlated to influenza antibody production, as measured by hemagglutination-inhibition assay (HAI). Influenza vaccine response in allo-HSCT recipients will be compared to that observed in Healthy Volunteers., 4 weeks after influenza vaccination.

Hospices Civils de Lyon

BioMérieux

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

69HCL17_0769|2017-A03230-53

2018-04-27

2021-01-21

2023-01-21

2018-09-06

2024-03-20

Hôpital de la Croix Rousse, Lyon, 69004, France|Centre Hospitalier Lyon Sud, Pierre-Bénite, 69495, France

{ "immune biomarkers to evaluate vaccine response in HSCT recipients": [ { "intervention_type": "BIOLOGICAL" } ] }

NCT04844073

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer

https://clinicaltrials.gov/study/NCT04844073

RECRUITING

The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC-101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101). Participants may receive treatment throughout the study for a maximum of 13 months and will be followed up at 30 days and 90 days and then every 12 weeks for up to 48 weeks after the last treatment.

NO

Squamous Cell Cancer of Head and Neck (SCCHN)|Non-small Cell Lung Cancer (NSCLC)|Colorectal Cancer

DRUG: TAK-186

Number of Participants with Treatment Emergent Adverse Events (TEAEs), An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. All non immune-related AEs with start date from first dose of study drug until 30 days after the last dose of study drug will be considered as TEAEs. All immune-related AEs with start date from first dose of study drug until 90 days after the last dose of study drug will be considered as TEAEs. AEs will be reported based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0., From the signing of ICF through 30 days after the last dose of study drug for non immune-related AEs, and through 90 days after the last dose of study drug for immune-related AEs (Up to approximately 13 months)|Number of Participants with Cytokine Release Syndrome/Infusion Reactions, Number of participants with infusion reactions as per American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading criteria will be reported. Grade 1 - Mild (Symptomatic Management): Fever ≥38^o C, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula or blow-by oxygen, Grade 3 - Severe (Aggressive Intervention): Fever ≥ 38^ o C , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula, facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation and mechanical ventilation)., From the signing of ICF through 30 days after the last dose of study drug (Up to approximately 13 months)|Number of Participants with a Dose-Limiting Toxicity (DLT), DLT Evaluation Period (up to Day 28) in Dose Escalation Phase

Recommended Phase 2 Dose (RP2D), Up to approximately 13 months|Cmax: Maximum Observed Plasma Concentration of TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|Tmax: Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) of TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|AUCtau: Area Under the Plasma Concentration-time Curve for a Dosing Interval for TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|Ctrough: Trough Plasma Concentration of TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|CL: Clearance of TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|Vss: Volume of Distribution at Steady State for TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|t1/2: Terminal Half-Life of TAK-186, Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)|Number of Participants with Anti-drug Antibodies (ADA) in Plasma for TAK-186, Up to approximately 13 months|Preliminary Anti-tumor Activity of TAK-186 in Participants with Advanced Cancer Based on Tumor Protein Marker Changes in Serum, Up to approximately 13 months|Objective Response Rate (ORR), ORR will be calculated based on the percentage of participants achieving Complete Response [CR] or Partial Response [PR] as per RECIST v1.1 (both confirmed and unconfirmed) and modified RECIST v1.1., Up to approximately 13 months|Duration of Response, Duration of response will be calculated for responders as the time from initial confirmed objective response (CR or PR) to the time of documented Progressive Disease (PD) using both RECIST v1.1 and modified RECIST v1.1 or death from any cause, whichever occurs first., Up to approximately 13 months|Progression-free Survival (PFS), PFS will be calculated as the time from the date of the first dose of study drug to the date of any documented confirmed PD using both RECIST v1.1 and modified RECIST v1.1 or the date of death from any cause, whichever occurs first., Up to approximately 13 months|Overall Survival (OS), OS will be calculated as the time from the first dose of study drug until the date of death due to any cause., Up to approximately 13 months

Takeda

ALL

ADULT, OLDER_ADULT

PHASE1|PHASE2

INDUSTRY

INTERVENTIONAL

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

CP-MVC-101-01

2021-03-08

2025-09-27

2026-11-01

2021-04-14

2024-04-30

University of California San Francisco, San Francisco, California, 94143-2202, United States|University of Colorado Anshutz Medical Campus, Aurora, Colorado, 80045, United States|University of Yale, New Haven, Connecticut, 06511, United States|Georgetown, Washington, District of Columbia, 20007-2113, United States|Indiana University, Indianapolis, Indiana, 46202-5149, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|Sanford University, Sioux Falls, South Dakota, 57104, United States|Avera Cancer Institute, Sioux Falls, South Dakota, 57105, United States|Mary Crowley Cancer Research, Dallas, Texas, 75230, United States|MD Anderson, Houston, Texas, 77030, United States|Chris O Brien Lifehouse, Camperdown, New South Wales, 2050, Australia|Scientia Clinical Research Limited, Corner High & Avoca Street, 5th Floor, Bright Building, Randwick, New South Wales, 2031, Australia|Southern Oncology Clinical Research Unit, 1 Flinders Drive, Bedford Park, South Australia, 5042, Australia|Monash Health, Monash Medical Center, 246 Clayton Road, Clayton, Victoria, 3168, Australia|The Alfred Hospital, Melbourne, Victoria, 3004, Australia|Austin Hospital, 145 Studley Road, Intensive Care Unit, Heidelberg, 3084, Australia|Seoul National University Hospital, Seoul, 03080, Korea, Republic of|Samsung, Seoul, 06351, Korea, Republic of

{ "TAK-186": [ { "intervention_type": "DRUG" } ] }

NCT02211573

Aquatic Aerobic Training, Cardiorespiratory and Metabolic Variables in Coronary Artery Disease

https://clinicaltrials.gov/study/NCT02211573

COMPLETED

Although approaches to reduce cardiovascular disease, coronary artery disease (CAD) remains the leading cause of mortality in the industrialized world. In order to reduce the deleterious effects of the atherosclerotic process, proposals for non-pharmacological treatment have been used, such as cardiac rehabilitation programs, with emphasis on exercise -based therapy. Traditionally aerobic exercises like biking, walking and jogging are conducted, however, alternative ways such as aquatic exercise training have been proposed, however, the cardiorespiratory adaptations in this population are not well documented in the literature. Thus, the aim of this study was to evaluate the effects of aquatic aerobic training (AAT) on body composition, autonomic modulation of heart rate (HR) and cardiorespiratory and metabolic variables in patients with CAD. This was a longitudinal clinical trial with a sample allocated for convenience, in which twenty-one patients were male, with a diagnosis of CAD, which were divided into control group (CG were studied, n=8), who was only assessed, and training group (TG, n=13). All patients underwent assessment of body composition, heart rate variability (HRV) at rest in the supine posture, and cardiopulmonary exercise testing (CPET), performed before and after the AAT program. The training protocol consisted of three sessions per week on alternate days for 16 weeks, totaling 48 sessions, which had lasted approximately one hour. The exercise intensity was prescribed between 80 and 110% of the first ventilatory threshold (VT1) obtained in CPET. Given that these parameters represent risk markers for cardiovascular events in the population studied, the results suggest that the AAT proposed in this study may be an important therapeutic strategy to be incorporated into cardiac rehabilitation programs.

NO

Arteriosclerosis, Coronary

OTHER: Exercise, Aerobic (Water based)

Change in autonomic system modulation, Change in autonomic system modulation in assess by comparing the heart rate variability at baseline and after a 16 weeks of aerobic water and land based physical training., baseline and 16 weeks

Change in body composition, Change in body composition is assess by comparing the body composition at baseline and after a 16 weeks of aerobic water and land based physical training., baseline and 16 weeks

Oxygen uptake, Change in oxygen uptake is assessed by comparing the oxygen uptake at baseline and after a 16 weeks of aerobic water and land based physical training., 16 Weeks

Universidade Metodista de Piracicaba

MALE

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

03/14

2013-05

2013-10

2014-03

2014-08-07

2014-08-07

Universidade Metodista de Piracicaba, Piracicaba, São Paulo, 55, Brazil

{ "Exercise, Aerobic (Water based)": [ { "intervention_type": "OTHER" } ] }

NCT04718831

Spirulina (FEM-102) Supplement to Chronic Hepatitis B Patients

https://clinicaltrials.gov/study/NCT04718831

COMPLETED

Hepatocellular carcinoma (HCC), listed among lung and breast cancers as the top-ten cancer in 2016 Taiwan, is the second most prevalent cancer, just one place below colon cancer. Due to mass hepatitis B vaccination and the screening and therapeutic plan against hepatitis B and C viruses (HBV and HCV, respectively), the incidence of liver cancer drops significantly, however, still around twenty out of per hundred thousand population die from liver cancer each year. For patients suffering HBV and HCV, the prevention of HCC is a crucial health issue.

NO

Chronic Hepatitis b

DIETARY_SUPPLEMENT: Spirulina

HBV DNA, The change of HBV DNA during six months, 6 months

Taipei Medical University WanFang Hospital

Far East Bio-Tec Co., Ltd

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

N201810002

2019-10-29

2020-08-30

2020-11-30

2021-01-22

2021-01-22

Wanfang Hospital, Taipei, Wenshan District, 116, Taiwan

{ "Spirulina platensis": [ { "intervention_type": "DIETARY_SUPPLEMENT", "description": "Spirulina", "name": "Spirulina platensis", "synonyms": [ "Arthrospira platensis whole", "Oscillatoria platensis", "Spirulina", "Spirulina platensis", "Spirulina platensis whole", "Arthrospira platensis", "Spirulina (arthrospira platensis)" ], "drugbank_id": "DB14744", "generic_names": [ "Spirulina platensis" ] } ] }

NCT04272931

DRAGON 1- Training, Accreditation, Implementation and Safety Evaluation of Combined PVE/HVE

https://clinicaltrials.gov/study/NCT04272931

DRAGON

ACTIVE_NOT_RECRUITING

Brief Summary: Some colorectal liver metastases can only be resected after inducing liver regeneration by portal vein embolization (PVE) to increase size function of the future liver remnant (FLR). While PVE is standard, embolization of portal vein and hepatic veins (PVE/HVE) on one side of the liver may faster and more extensive liver size and function growth. PVE/HVE is a novel procedure and requires a safety and feasibility evaluation in a pretrial (DRAGON1) to then be compared in a randomized controlled trial (RCT) to PVE (DRAGON 2).

NO

Colorectal Cancer Liver Metastases

PROCEDURE: Portal and Hepatic Vein Embolization

Ability of each center to enroll 3 patients in 12 months without mortality due to the intervention., Ability of each center to enroll 3 patients for PVE/HVE in 12 months safely and perform the procedure including the liver resection without 90-day mortality after resection due to complications. If this goal is achieved center will be enrolled in DRAGON 2., 1 year/ 90 day mortality

Efficacy assessment: standardized future liver remnant volume, Increased of standardized future liver remnant volume between initial imaging and imaging at 1 week, 3 weeks, 6 weeks, degree of hypertrophy based on standard future liver remnant volume, kinetic growth, 6 weeks|Feasibility assessment: resection rate, ion of patients proceeding to complete resection (=resection rate), 1 year follow up|Mortality assessment, 90-mortality after resection, 90 days|Overall survival after PVE/HVE, Overall survival, 1 year follow up|Oncological effectiveness of PVE/HVE, Disease-free survival after 1 year, 1 year|General complication assessment, 90-day complications, general (Clavien-Dindo), 90 days|Liver specific complication assessment, 90-day complications, liver specific (FABIB-classification), 90 days

Maastricht University

Koningin Wilhelmina Fonds

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

NL71535.068.19

2020-05-08

2022-10-01

2023-12-31

2020-02-17

2023-02-03

Yale School of Medicine, New Haven, Connecticut, 06510, United States|Rush University Medical Center, Chicago, Illinois, 60612, United States|Memorial Sloan Kettering Cancer Center, New York, New York, 10065, United States|Royal Prince Alfred Hospital, Camperdown, New South Wales, NSW 2050, Australia|Monash Health, Clayton, Clayton, Victoria, VIC 3168, Australia|Social Medical Center, South, Vienna, 1100, Austria|Hôpital Erasme, Brussels, Bruxelles, 1070, Belgium|CHU-UCL Namur site Godinne, Yvoir, Namen, 5530, Belgium|CHU de Liège, Liège, 4000, Belgium|The Ottawa Hospital, Ottawa, Ontario, k1H 8L6, Canada|McGill University Health Center, Montréal, Canada|Klinikum Saarbrücken gGmbH, Saarbrücken, Saarland, 66119, Germany|University Hospital Halle (Saale), Halle (Saale), Saksen-Anhalt, 06120, Germany|Frankfurt University Hospital, Frankfurt, Germany|Policlinico Sant Orsola-Malpighi, Bologna, 40138, Italy|Fondazione Poliambulanza, Brescia, 25124, Italy|IRCCS San Raffaele Hospital, Milan, Italy|Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, 00168 Roma, Italy|Maastricht University Medical Center+, Maastricht, Limburg, 6229 HX, Netherlands|Amsterdam UMC, location AMC, Amsterdam, Noord-Holland, 1105 AZ, Netherlands|Erasmus Medical Center, Rotterdam, Zuid-Holland, 3015, Netherlands|Amsterdam Medical Centers, Location VUmc, Amsterdam, 1081HV, Netherlands|Amphia, Breda, Netherlands|Maxima Medisch Centrum, Eindhoven, Netherlands|University Medical Center Groningen, Groningen, 9713 GZ, Netherlands|Universitair Medisch Centrum Utrecht, Utrecht, Netherlands|Oslo University Hospital, Oslo, 0450 Oslo, Norway|University Hospital Germans Trias I Pujol, Badalona, Barcelona, 08916 Badalona, Spain|University Hospital Parc Taulí, Sabadell, Barcelona, 08208, Spain|Hospital Universitari Mútua Terrassa, Terrassa, Barcelona, 08221, Spain|Hospital Universitari Dr. Josep Trueta, Girona, Gerona, 17007, Spain|Clínic de Barcelona, Barcelona, 08036, Spain|University Hospital Miguel Servet, Zaragoza, 50009, Spain|Linköping University Hospital, Linköping, 581 85, Sweden|Karolinska University Hospital, Stockholm, 14186, Sweden|Claraspital & Clarunis University Hospital Basel, Basel, Basel-Stadt, CH-4058, Switzerland|Kantonsspital Winterthur (KSW), Winterthur, 8401, Switzerland|University Hospital Southampton, Southampton, Hampshire, SO16 6YD, United Kingdom|Aintree University Hospital, Liverpool, Merseyside, L9 7AL, United Kingdom|Belfast Health and Social Care Trust, Belfast, United Kingdom|King s college hospital NHS foundation trust, London, United Kingdom|Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom

{ "Portal and Hepatic Vein Embolization": [ { "intervention_type": "PROCEDURE" } ] }

NCT01936831

High-Dose Isoniazid Among Adult Patients With Different Genetic Variants of INH-Resistant Tuberculosis (TB)

https://clinicaltrials.gov/study/NCT01936831

COMPLETED

Isoniazid (INH) is a drug commonly used to treat tuberculosis (TB) worldwide. Sometimes, the bacteria that cause TB can become resistant to INH. Resistance means that bacteria have adapted to a drug and are able to live in the presence of the drug. When TB becomes resistant to INH, INH does not work as well at fighting the bacteria. This study treated people with INH-resistant TB with different doses of INH to see if INH can still fight the bacteria if the dose is increased. We evaluated how well the drug works at higher doses for participants who have resistant TB as well as how well the drug works at regular doses for participants who have TB that is not resistant. The study also evaluated the safety and tolerability of the different doses of INH. Tolerability is how well people can put up with the side effects of a drug. Using increased doses of INH to treat TB that is resistant to INH is experimental and has not been approved by regulatory authorities. While there is some evidence that this approach will work, this has not yet been proven.

YES

Tuberculosis

DRUG: Isoniazid|DIETARY_SUPPLEMENT: Vitamin B6

Daily Change in log10 Colony-forming Unit (CFU), Negative daily change in log10 CFU indicate decreases in bacterial burden over the 7 day period. Defined as EBA0-7(CFU) = [Day 7 log10 CFU per mL - baseline log10 CFU per mL]/7. The baseline measure is the mean of the pre-entry visit and entry visit sputum colony counts., Measured at baseline and Day 7|Daily Change in Time to Positivity (TTP), The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the 7 day period and is therefore better. Daily change is defined as EBA0-7(TTP) = [Day 7 TTP - Baseline TTP]/7. Baseline is the mean of the pre-entry visit and entry visit TTPs., Measured at baseline and Day 7|INH PK Parameter Area Under the Concentration Time Curve (AUC 0-24 Hours), AUC 0-24h defines area under the concentration-time curve over the period of 24 hours post-dose, estimated through non-compartmental methods using the linear trapezoidal rule., Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.|Number of Participants With Grade 2 or Higher Drug-related Adverse Clinical or Laboratory Events, Post-entry, all new diagnoses, signs/symptoms and laboratory events of ≥Grade 2 that were assessed by the site as drug related. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used., Measured from entry through Day 21

INH PK Parameter Minimum Plasma Concentration (Cmin), Cmin defines minimum concentration observed over the 24 hours of the INH dosing interval., Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.|INH PK Parameter Maximum Plasma Concentration (Cmax), Cmax defines maximum concentration observed over the 24 hours of the INH dosing interval., Intensive INH PK samples collected on Day 6 of INH initiation at sample times pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose.|INH Minimum Inhibitory Concentration (MIC) Against M. Tuberculosis Isolates, MIC are determined by phenotypic drug susceptibility testing (DST) based on spot sputum collected at Step 1 Day 0. For group 3 participants shown, MIC was tested using Thermofisher Sensititre MYCOTB plates., Day 0|Proportions of Participants Estimated to Have a Drop in log10 CFU/mL at or Above 0.65 log10 CFU/mL., Proportions of participants obtained through simulation using the estimated model who have a drop in log10 CFU/mL at or above the threshold of 0.65 log10 CFU/mL; 0.65 is half the drop in log10 CFU/mL observed in participants with DS-TB (Group 2) on day 7. A total of 10000 simulated pseudo-participants per arm were used based on data from the study participants. The NAT2 genotype distribution was based only on Group 1 and 2 participants since NAT2 genotype data was not available for Group 3. The simulations were run repeatedly. The point estimate of the proportion was based on the median proportion of the pseudo-individuals across the repeated simulations and the 90% confidence interval used the 5th and 95th percentiles of the proportion across the repeated simulations., From baseline through day 7|Daily Change in log10 CFU Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models, Negative daily change in log10 CFU indicate decreases in bacterial burden over the time period. The mean CFU are estimated using all values by fitting a biphasic regression models for each participant. The daily change for the first two days of treatment was calculated as EBA0-2 (CFU)= [Day 2 log10 CFU per mL - baseline log10 CFU per mL]/2. The daily change from day 2 to day 7 was calculated as EBA2-7 (CFU)= [Day 7 log10 CFU per mL - Day 2 log10 CFU per mL]/5. Baseline is the average of pre-entry and entry visits., At baseline, day 2, and day 7|Daily Change in TTP Measured by Early- (EBA0-2) and Late-phase (EBA2-7) Individual-based Parameter Estimates From Nonlinear Models, The time to positivity (TTP) measures growth of mycobacterium tuberculosis using MGIT assay in hours. Higher values of daily change in TTP indicate greater decrease in bacterial burden over the time period and is therefore better. The mean log transformed TTP are estimated using all values by fitting a biphasic regression models for each participant. The daily change over the first two days of treatment is calculated as EBA0-2 (TTP)= [Day 2 TTP - baseline TTP]/2. The daily change from Day 2 to Day 7 is calculated as EBA2-7 (TTP)= [Day 7 TTP - Day 2 TTP]/5. Baseline is the average of pre-evaluation and entry visits., At baseline, day 2, and day 7|EBA Measured by Individual-based Parameter Estimates From Linear or Nonlinear Models When the Number of Phases Differs Between Every Dosing Cohort, Both TTPs and log10 CFU from the pre-evaluation and entry visits averaged and treated as the baseline TTP and log10 CFU for each participant. This outcome was included for analysis if the number of phases differed between every dosing cohort. Since the number of phases did not differ between dosing cohorts, this outcome was not measured., From baseline through day 7|Mean EBA Measured by Ratio of the Following Areas: Numerator = AUC of Observed log10 CFU Over 7 Days and Denominator = Baseline log10 CFU for Every Dosing Cohort in Groups 1 and 2, This approach utilizes the area between baseline CFU per mL and the CFU curve for each participant, as measured using the trapezoidal rule. This outcome was included for analysis if the number of phases differed between every dosing cohort. Since the number of phases did not differ between dosing cohorts, this outcome was not measured., From baseline through day 7

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections

National Institute of Allergy and Infectious Diseases (NIAID)

ALL

ADULT, OLDER_ADULT

PHASE2

NETWORK

INTERVENTIONAL

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

ACTG A5312|UM1AI068636

2014-08-13

2021-09-22

2021-10-06

2013-09-06

2023-02-17

2023-02-17

GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (31730), Port Au Prince, Haiti|TASK Applied Science CRS (31718), Bellville, 7531, South Africa

Study Protocol and Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/31/NCT01936831/Prot_ICF_000.pdf|Statistical Analysis Plan: Primary Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/31/NCT01936831/SAP_001.pdf|Statistical Analysis Plan: Pharmacology Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/31/NCT01936831/SAP_002.pdf

{ "Isoniazid": [ { "intervention_type": "DRUG", "description": "Isoniazid", "name": "Isoniazid", "synonyms": [ "Rimifon", "Isonicotins\u00e4urehydrazid", "Hyzyd", "Tubizid", "Isoniazid", "Isonicotinic acid hydrazide", "Laniazid", "Isonicotinylhydrazine", "Isonicotinic hydrazide", "Isonicotinohydrazide", "INH", "Isoniazida", "4-pyridinecarbohydrazide", "Pyridine-4-carboxylic acid hydrazide", "Isonicotinoylhydrazide" ], "medline_plus_id": "a682401", "generic_names": [ "Isoniazid" ], "drugbank_id": "DB00951" } ], "Vitamin B6": [ { "intervention_type": "DIETARY_SUPPLEMENT" } ] }

NCT04080531

Influenza Vaccination for Flu Prevention in Patients With Plasma Cell Disorders

https://clinicaltrials.gov/study/NCT04080531

COMPLETED

This phase IV trial studies how well influenza vaccination works in preventing infections such as influenza in patients with plasma cell disorders. Influenza infections may theoretically support the growth of tumor cells and improving protection against influenza may improve the status of patients plasma cell disorder. Giving influenza vaccination may reduce influenza-related complications including infections, hospitalizations, and deaths, and improve the status of plasma cell disorders.

NO

Plasma Cell Neoplasm

BIOLOGICAL: Pneumococcal 13-valent Conjugate Vaccine|BIOLOGICAL: Trivalent Influenza Vaccine

Change in hemagglutination antibody inhibition (HAI) from baseline, Assess change in HAI in blood from baseline compared to week 21, 21 weeks

Time to progression (TTP), Time to progression is defined as the time from last treatment until progression. Patients who have died without evidence of progression are censored in the TTP analysis at the time of death and patients who are alive without progression are censored at the last disease assessment., From last treatment until progression, assessed up to 2 years|Progression free survival (PFS), Defined as the time from last treatment to the disease progression or death from any cause. Patients who have not progressed or died are censored at the date last known progression-free. Patients with no on-study assessment will be censored at the time of registration., From last treatment to the disease progression or death from any cause, assessed up to 2 years|Overall survival (OS), OS is defined as the time from randomization to death. Alive patients are censored at the date last known alive., From randomization to death, assessed up to 2 years

Emory University

Sanofi|National Institutes of Health (NIH)|National Cancer Institute (NCI)

ALL

ADULT, OLDER_ADULT

PHASE4

OTHER

INTERVENTIONAL

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

IRB00111721|NCI-2019-03734|Winship4709-19|P30CA138292

2019-10-18

2021-05-11

2022-12-15

2019-09-06

2024-02-20

Emory University Hospital Midtown, Atlanta, Georgia, 30308, United States|Emory University Hospital/Winship Cancer Institute, Atlanta, Georgia, 30322, United States

Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/31/NCT04080531/ICF_000.pdf

{ "Pneumococcal 13-valent Conjugate Vaccine": [ { "intervention_type": "BIOLOGICAL" } ], "Influenza vaccine": [ { "intervention_type": "BIOLOGICAL", "description": "Trivalent Influenza Vaccine", "name": "Influenza vaccine", "synonyms": [ "Afluria", "Influenza vaccine", "Fluarix", "Fluzone", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine", "Afluria", "Influenza Vaccine, Inactivated or Recombinant", "Flucelvax", "Fluarix", "Fluzone", "Flu Vaccine" ], "wikipedia_url": "https://en.wikipedia.org/wiki/Influenza%20vaccine", "generic_names": [ "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant", "Influenza Vaccine, Inactivated or Recombinant" ] } ] }

NCT03099031

Non Interventional Study of the Validation of the Ottawa Score in Cancer Patients With Venous Thromboembolism (VTE)

https://clinicaltrials.gov/study/NCT03099031

PREDICARE

COMPLETED

The purpose of this study is to validate the Ottawa score (risk of thromboembolic recurrences) in cancer patients with thromboembolic disease treated with tinzaparin (Innohep®)

NO

Venous Thromboembolism

DRUG: Tinzaparin

Venous thromboembolism recurrence, 6 months

Major hemorrhage, 6 months|Death, All cause mortality, 6 months|Heparin induced thrombocytopenia, 6 months

Premature treatment discontinuation, 6 months

LEO Pharma

ALL

ADULT, OLDER_ADULT

INDUSTRY

OBSERVATIONAL

Observational Model: |Time Perspective: p

NIS-INNOHEP-1093

2015-05

2017-05-15

2017-05-15

2017-04-04

2019-12-16

George Pompidou European Hospital, Paris, France

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NCT06167031

Chatbot Facilitated Education on Child and Adolescent Abuse

https://clinicaltrials.gov/study/NCT06167031

COMPLETED

Background: Child and adolescent abuse and neglect (CAAN) cases are increasing both in Taiwan and worldwide. As the first healthcare professionals who come in contact with CAAN cases, nurses play a crucial role. Studies show that the lack of professional knowledge and ability of nursing staff on CAAN affects the effectiveness of timely identification and notification. Therefore, it is extremely important to improve the knowledge and ability of nursing staff to assess and report CAAN. With advancements in technology, continuing education for nurses is now more extensive than traditional lecture teaching. Online education, which breaks down the barriers of time and space in learning, has thrived after the COVID-19 pandemic. Chatbots are an option for individual learning and can increase accessibility and convenience for nurses learning how to recognize and report CAAN. Objective: The aims of the study are to evaluate the effectiveness of using chatbots as teaching aids to assist nursing personnel in preventing child abuse. This evaluation will be the impact of learning on CAAN competency. Method: The study utilizes an experimental design in which participants are purposively sampled and subsequently randomized into either the experimental or control group. The experimental group will use chatbot to facilitate teaching. The control group only receives lecture-based teaching. The course content is comprised of two main subjects: CAAN and Nurses Roles and Functions in CAAN, which was developed using the ADDIE model. The study employs the CAAN Knowledge and Competency Scale which retrieves from the Child abuse report intention scale (CARIS) by Feng and Wu (2005). Additionally, the learning effect is assessed at three different time points: before the course, one week after, and four weeks after. Expected Results: The study predicts that the learning effects of the experimental group, which used chatbots, will be better than those of the control group. It is expected that these results will be able to implement in various educational fields, including CAAN and interdisciplinary teams.

NO

Child Abuse

OTHER: chatbot facilitate teaching|OTHER: lecture-based teaching

intention to report questionnaire, The questionnaire has eight child abuse cases, and the participants will select a score from 0 to 10 depending on their intention to report. A higher score means they intend to report the cases., Three different time points: Baseline (before the course), one week after, and four weeks after.|attitude toward reporting questionnaire, The questionnaire has three aspects, which are child discipline, abusive parents, and professional responsibility for reporting child abuse. The participants will select a score from 0 to 6, depending on their agreement level. A higher score means they have negative attitudes toward child physical discipline, lower tolerance towards the perpetrators, and positive attitudes toward the responsibility of reporting suspected child abuse., Three different time points: Baseline (before the course), one week after, and four weeks after.|knowledge questionnaire, The questionnaire has thirteen true-false questions. A higher score means they have enough knowledge of child abuse and the relative law., Three different time points: Baseline (before the course), one week after, and four weeks after.

Tzu Chi University

ALL

ADULT, OLDER_ADULT

OTHER

INTERVENTIONAL

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

IRB112-148-B

2024-01-10

2024-01-17

2024-04-08

2023-12-12

2024-05-29

Tzu Chi University, Hualien City, Hualien County, 970374, Taiwan

{ "chatbot facilitate teaching": [ { "intervention_type": "OTHER" } ], "lecture-based teaching": [ { "intervention_type": "OTHER" } ] }

NCT04142931

Sequentional Immuno Apheresis Plasma Volume Escalation Cohort Study of Reduction of Soluble Tumor Necrosis Factor Receptors 1 and 2 (sTNFR1/2) With or Without Nivolumab in Patients With Inoperable or Metastatic Solid Tumors

https://clinicaltrials.gov/study/NCT04142931

UNKNOWN

Sequential immune apheresis plasma volume escalation cohort study of reduction of soluble Tumor Necrosis Factors Receptors 1/2 (sTNFR1/2), with or without Nivolumab, in patients with inoperable or metastatic solid Tumors. This study evaluates Immunicom fs LW-02 device used with Spectra Optia apheresis system, aiming to answer two different study questions: * Safety, tolerability and effectiveness of the device. * Safety, tolerability and effectiveness of the device, employed as monotherapy, or combined with Nivolumab.

NO

Stage IV Non-small Cell Lung Cancer|Stage IV Melanoma|Triple Negative Breast Cancer|Renal Cell Carcinoma Stage IV

COMBINATION_PRODUCT: ImmunicomAIAC

Incidence of Treatment-Emergent Adverse Events (Safety) of IA therapy with plasma volume escalation (increase from 2X to 3X plasma volume processed): adverse events, number of patients with adverse events that emerged due to IA, two years|Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) of IA therapy in combination with nivolumab: adverse events, number of patients with adverse events that emerged due to IA therapy in combination with nivolumab., two years|Column efficiency, Changes in sTNFR-1/2 pre and post AIAC column between start and end of every treatment session, and between start and end of every cycle Total capture of sTNF-R1/2 on each column post treatment will be measured using an elution procedure, two years|Column biochemical effectiveness, The biochemical efficacy will be evaluated throughout the study by measuring the changes of sTNFR-1/2 and TNFα in the plasma in several pre-defined time points - before, during and post every AIAC treatment, two years

Clinical efficacy: Response Rate (RR) as determined by RECIST v1.1, Response Rate (RR) as determined by RECIST v1.1, two years|Circulating biomarkers in plasma cytokines Levels, changes in plasma cytokines levels: sTNFR-I (pg/ml), sTNFR-II (pg/ml), TNF (pg/ml), pre and post treatment., two years|Circulating biomarkers in peripheral blood mononuclear cells (PBMC), changes in peripheral blood mononuclear cells (PBMC) phenotypes pre and post treatment, two years|Duration of response, Duration of response (DoR) as determined by RECIST v1.1, two years|Clinical benefit rate, Clinical benefit rate (CBR) defined as CR plus PR plus stable disease (SD) ≥6 months, two years|Progression Free Survival, Progression-Free Survival (PFS) as determined by RECIST v1.1, two years|Overall Survival, Overall Survival (OS), two years|Clinical efficacy by physician evaluation of ECOG status, Eastern Cooperative Oncology Group (ECOG) status (score 0-4), two years|Patient reported outcomes by questionnaire EORTC QLQ-C30, Overall quality of life scale: 1 (very poor), 7 (excellent). higher score mean better outcome, two years|Patient reported outcomes by questionnaire EQ-5D- 5L, patient s health state: 1- The best health you can imagine , 5- The worst health you can imagine . higher score mean worse outcome, two years|Patient reported outcomes by questionaire Hospital Anxiety and Depression Scale (HADS), measure anxiety and depression in a general medical population of patients. 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case), two years

Dr. Ronnie Shapira

Immunicom Inc. San Diego California, USA

ALL

ADULT, OLDER_ADULT

PHASE1

OTHER_GOV

INTERVENTIONAL

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

SHEBA-19-6136-RS-CTIL

2020-02-24

2021-12-30

2022-12-30

2019-10-29

2021-03-24

Sheba Medical Center, Ramat Gan, 5262100, Israel

{ "ImmunicomAIAC": [ { "intervention_type": "COMBINATION_PRODUCT" } ] }