louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02646709: The Effect of Different Dose of Ketamine With Low Dose Rocuronium in Children
Official title: The Effect of Different Doses of Ketamine on Tracheal Intubating Conditions Using Low Dose Rocuronium in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Inguinal Hernia
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Rocuronium is suitable for rapid induction within 60-90 seconds and its effect last 24-40 minute after single bolus injection. For outpatient surgery with short operation time, low dose rocuronium is frequently used for rapid recovery at the expense of compromised intubating condition. For better intubating condition, ketamine can be used. However, appropriate dose of ketamine with low dose rocuronium is not established yet. This study, 3 different doses of ketamine with low dose rocuronium will be compared for appropriate intubating condition.


Eligibility criteria: Inclusion Criteria:

* ASA class I, II

Exclusion Criteria:

* upper respiratory infection within 14 days
* anticipated difficult intubation

Primary outcomes:
measure: Intubation Condition
timeFrame: during and after intubation, about 2 minute
Secondary outcomes:
measure: heart rate
timeFrame: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation
measure: time for extubation
timeFrame: from the end of surgery to extubation, within 10 min
measure: emergence agitation (4 points scale)
timeFrame: 5 min after postanesthesia care unit (PACU) admission
measure: PACU time
timeFrame: from PACU admission to discharge, about 30 min
measure: severity of vomiting
timeFrame: 1. 1 min after PACU admission 2. 30 min after PACU admission
measure: Analgesic requirements (mg/kg)
timeFrame: during PACU stay, about 30 min
measure: Desaturation
timeFrame: during PACU stay, about 30 min
measure: blood pressure
timeFrame: 1. 1 min before induction 2.1 min after ketamine injection 3. 1min after intubation 4. 5 min after intubation 5. 10 min after intubation
measure: frequency of vomiting
timeFrame: 1. 1 min after PACU admission 2. 30 min after PACU admission
Other outcomes:
Locations:
Study officials:
affiliation: Ajou University School of Medicine
name: Go Un Roh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05244109: Biomedicines and Bacterial Translocation in Spondyloarthritis
Official title: Bacterial Translocation in Spondyloarthritis: Evaluation Before and After Starting a Biomedicine.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Axial Spondyloarthritis
Keywords: bacterial translocation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this project is to evaluate the effect of anti-TNF and anti-IL17 biotherapies on bacterial translocation in patients with NSAID-resistant axial spondyloarthritis.

Detailed description: Axial spondyloarthritis is a common inflammatory rheumatic disease and its management is based on the use of NSAIDs and biotherapies (anti-TNF and anti-IL17 antibodies). Its pathophysiology involves the digestive mucosa. The colon of patients with spondyloarthritis is the site of asymptomatic inflammation. This inflammation results from dysbiosis, which is responsible for activation of innate immunity linked to bacterial translocation phenomena. Dendritic cells are then activated and the immune response is polarized towards the IL23/Th17 axis. This translocation is secondary to an increase in colonic permeability. The increase in digestive permeability allows translocation of bacteria or bacterial fragments, primarily lipopolysaccharide (LPS).

Some proinflammatory cytokines (TNF, IFNγ, and IL23) cause an increase in digestive permeability. IL17 produced in the digestive mucosa has two different effects. Indeed, two types of colonic T cells produce IL17: regulatory T Helpers 17 producing IL10 and IL17 and inflammatory T Helpers 17 producing IL17 and IFNγ.

The investigators hypothesize that biotherapies decrease bacterial translocation. They suspect a lesser effect of anti-IL17 compared to anti-TNF because of the potential inhibition of Treg17 lymphocytes.

Eligibility criteria: Inclusion Criteria:

* Axial spondyloarthritis (2009 ASAS criteria)
* NSAID arm: Responding to any class of NSAID and not likely to initiate biotherapy
* anti-TNF/anti-IL-17 arms: Need to introduce a biomedical drug according to current recommendations (objective signs of inflammation, i.e. MRI sacroiliitis or increased CRP, and failure of two NSAIDs of different classes)

Exclusion Criteria:

* IBD already diagnosed by a gastroenterologist or suspicion of IBD (bloody diarrhea)
* Previous exposure to a biomedical drug (anti TNF or anti IL 17).
* Antibiotic use in the 3 months prior to inclusion
* Contraindications for treatment with anti-TNF or anti-IL17 (for all patients)

Primary outcomes:
measure: Difference in serum LPS concentration
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
References:
Clinical trial NCT00402909: Safety and Efficacy of Nateglinide in Patients With Type 2 Diabetes Already Taking Insulin Glargine, Metformin and/or Pioglitazone or Rosiglitazone
Official title: A 16-week, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Compare the Safety and Efficacy of Nateglinide vs. Placebo in Patients With Type 2 Diabetes Who Are Inadequately Controlled With Basal Insulin Glargine in Combination With Metformin and/or Thiazolidinedione (Pioglitazone or Rosiglitazone)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes,
fasting glucose,
postprandial glucose,
blood sugar,
HbA1c,
insulin,
glargine,
metformin,
thiazolidinedione
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of adding nateglinide to treatment with basal insulin glargine, metformin and/or thiazolidinedione (pioglitazone or rosiglitazone), for patients with type 2 diabetes who are not achieving glycemic control with glargine, metformin and/or thiazolidinedione only.


Eligibility criteria: Inclusion Criteria:

* Male/female, age 18-78 inclusive
* Type 2 diabetes, taking glargine, metformin and/or thiazolidinedione for 3 months prior to screening, stable doses for 2 months prior to screening
* HbA1c 7.0-8.5% inclusive
* Fasting plasma glucose \<240 mg/dL at screening
* Body Mass Index 22-41 kg/m2

Exclusion Criteria:

* Pregnant or nursing
* Other investigational drugs within 30 days of screening
* Treatment with other anti-diabetic medications other than metformin, glargine and/or thiazolidinedione
* History of type 1 diabetes
* Abnormal kidney function
* History of acute diabetic complications
* Congestive heart failure requiring treatment
* Myocardial infarction, coronary artery surgery, stroke within 6 months of screening
* Liver disease, liver enzymes more than 3 times upper limit of normal
* Fasting triglycerides \>700 mg/dL within past 12 weeks
* Acute infections or other conditions that may affect blood sugar or may interfere with interpretation of study data
* Treatment with corticosteroids
* Blood donation within past 12 weeks

Other protocol-defined inclusion/exclusion criterial may apply.

Primary outcomes:
measure: Change from baseline in hemoglobin (Hb)_A1c
Secondary outcomes:
measure: Change from baseline in 2-hour postprandial glucose during standardized meal test
measure: Proportion of patients achieving American Diabetes Association ADA goal of HbA1c <7.0%
measure: Proportion of patients achieving reduction in HbA1c of 0.5%
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT03184909: Tulsi Consumption and Its Effects on Cognition, Stress and Anxiety
Official title: Consumption of Tulsi and Its Effects on Neurocognition, Stress and Anxiety: A Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2017-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Tulsi and its effects on facilitative cognitive enhancement through lowering levels of stress and anxiety. A randomised placebo-controlled clinical trial.

Detailed description: Ocimum Sanctum or Holy Basil, commonly called Tulsi is a traditional Indian herb. It is believed to bring about a facilitative enhancement of cognitive ability and lower stress levels in individuals. Stress and an inability to perform at a required level of cognition can induce anxiety. This study is looking at the effects of daily consuming Tulsi among a group of individuals who work in an environment that demands memory, attention and executive functioning.

Eligibility criteria: Inclusion Criteria:

* Subjects between the ages of 18 and 50 years, providing written informed consent.

Exclusion Criteria:

Subjects who meet the following criteria

* Education level below 8th grade of schooling
* Unable to read or understand English or having no working knowledge of English
* Known history or neurological conditions that can affect cognition
* Known history of drug abuse or potential for drug abuse, a regular consumer of alcohol or unwilling to withhold consumption of alcohol for the duration of the study.
* A chronic smoker or consumer of other tobacco related products or is undergoing a rehabilitation program for alcohol and or tobacco consumption
* Any history or psychiatric disorders - currently on treatment or treated in within the last 12 months
* Any characteristic that makes the investigator uncomfortable to include the subject in the study.

Primary outcomes:
measure: To assess a change in facilitative cognitive function from baseline in 6 weeks by comparing the results on cognitive tests measured by Cambridge Neuropsychological Test Automated Battery (Cantab®) between active and placebo group
timeFrame: 6 weeks
Secondary outcomes:
measure: To measure change in cortisol level from saliva in 6 weeks
timeFrame: 6 weeks
measure: To measure change in Generalized Anxiety Disorder 7-Item Scale in 6 weeks
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Narayana Hrudayalaya Limited, Mazumdar Shaw multispecialty Hospital
state: Karnataka
Study officials:
affiliation: Narayana Hrudayalaya Limited
name: Alben Sigamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06826209: Comparison of Upper Extremity Functional Performance in Hemophilic and Healthy Children
Official title: Comparison of Upper Extremity Functional Performance, Muscle Strength, and Activities of Daily Living Levels in Children with Hemophilia and Healthy Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hemophilia
Upper Extremity
Strength
Performance
Children
Keywords: Hemophilia
Muscle Strength
Upper Extremity
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 30
Sex: MALE
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male children diagnosed with Hemophilia, who are being followed by the same physician at the Hematology Unit of the Department of Pediatrics, Faculty of Medicine, Hacettepe University, will be included in the study

Brief summary: The goal of this observational study is to evaluate the functional performance of the upper extremity joints (scapula, shoulder, elbow, and wrist) in haemophilic children and compare muscle strength and ADL limitations with healthy children.

Detailed description: This study aims to evaluate the upper extremity functional performance, muscle strength, and daily living activity levels of hemophilic children and compare them with healthy children. The goal is to determine the effects of hemophilia on these children and contribute to the development of appropriate rehabilitation strategies. Parameters include explosive strength, isometric muscle strength, wrist grip strength, and functional exercise capacity. Additionally, the ADL-Glittre pediatric version test and Hemophilia Joint Health Score (HJHS) will be used to assess joint health and GYA performance. Muscle strength is crucial for hemophilic children to perform daily activities, and the relationship between muscle strength and GYA levels will be investigated. The project aims to guide the development of physiotherapy and rehabilitation strategies for hemophilic children and contribute to the literature by filling existing gaps, ultimately creating an important reference for healthcare professionals and families.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Hemophilia A or B
* Receiving prophylaxis treatment (a routine treatment)
* Negative for inhibitors at the time of enrollment

Exclusion Criteria:

* Positive for inhibitors at the time of enrollment
* Acute elbow bleeding
* History of acute muscle bleeding
* History of surgery in any upper extremity joints
* Having undergone radionuclide synovectomy

Primary outcomes:
measure: Hemophilia Joint Health Score
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Muscle Strength
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe Universit
Study officials:
References:
Clinical trial NCT01169909: Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia
Official title: The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pterygium
Keywords: Pterygium
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2010-07-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.

Detailed description: Ptergyia are chronic fibrovascular lesions of the ocular surface. This study is designed to look for a signal of efficacy when the lesions are in a phase of active vascular growth. This phase is most often caught in a newly recurring pterygia post-operatively.

Patients identified with actively growing lesions, will be offered local injections directly beneath the lesions. They will be examined for any adverse side effects and regression of the lesion.

Eligibility criteria: Inclusion Criteria:

Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.

Exclusion Criteria:

* Pregnancy
* History of CVA
* Monocular patients
* Minors

Primary outcomes:
measure: Safety
timeFrame: Within the first 30 days after injection
Secondary outcomes:
measure: Regression of pterygium
timeFrame: Within 30 days after drug injection
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Science Center
state: New Mexico
Study officials:
References:
Clinical trial NCT00344409: A Double-blind Study of KRN321 for the Treatment of Anemia in Cancer Patients
Official title: A Double-blind, Placebo Controlled, Randomized Study of KRN321 for the Treatment of Anemia in Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: darbepoetin alfa
anemia
cancer patients
platinum containing chemotherapy
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2006-06-26
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of KRN321 to placebo in the treatment of anemia in cancer patients receiving multi cycle platinum-containing chemotherapy


Eligibility criteria: Inclusion Criteria:

* patients diagnosed as lung or gynecological cancer
* patients receiving platinum containing chemotherapy
* written informed consent
* hemoglobin concentration less than 11 d/dL at enrollment
* life expectancy of more than 4 months

Exclusion Criteria:

* hemolysis, gastrointestinal bleeding, postoperative bleeding
* iron deficiency
* megaloblastic anemia
* any primary hematological disorder that could cause anemia
* received \> 2 RBC transfusions with 4 weeks or any RBC transfusion within 2 weeks before randomization
* prior treatment with KRN321
* received erythropoetin therapy within 8 weeks before treatment

Primary outcomes:
measure: To compare the proportion of subjects who reach red blood cell transfusion trigger
Secondary outcomes:
measure: To compare the effectiveness of KRN321 on the proportion of subjects achieving hemoglobin response
measure: To compare the proportion of subjects who receive red blood cell transfusions
measure: To compare the effectiveness of KRN321 based on quality of life scores
Other outcomes:
Locations:
city: Ehime
country: Japan
facility: Shikoku region
city: Fukuoka, Kagoshima
country: Japan
facility: Kyusyu region
city: Hiroshima, Tottori
country: Japan
facility: Chugoku region
city: Iwate, Miyagi
country: Japan
facility: Tohoku region
city: Nara, Osaka, Hyogo
country: Japan
facility: Kinki region
city: Shizuoka, Aichi
country: Japan
facility: Tokai region
city: Tokyo, Chiba, Ibaraki, Saitama, Niigata
country: Japan
facility: Kanto region
Study officials:
affiliation: National Cancer Center Hospital East
name: Nagahiro Saijo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00763009: Persantine: Variation in Response Trial
Official title: Persantine: Variation in Response Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Coronary Artery Disease
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2008-09-30
Enrollment: 8
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.

Detailed description: Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the gene for the adenosine transporter will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Patients \> 21 years old
* Patient undergoing cardiac catheterization with planned PTCA or with a significant coronary lesion of either the LAD or Circumflex

Exclusion Criteria:

* Theophylline or oral Persantine use in 24hrs
* Second or third degree AV block, or sick sinus syndrome without a functioning pacemaker
* Active asthma or bronchospasm
* Patients with severe hepatic insufficiency
* Patients experiencing an acute transmural infarction at the time of the index visit
* Conditions that are known to affect resistive vessel function or myocardial flow

Primary outcomes:
measure: To Determine if There is a Subgroup of Patients That Have an Abnormal Adenosine Transporter Expression, or Abnormal Adenosine Transporter Protein Function.
timeFrame: 6-12 months
Secondary outcomes:
measure: To Determine the Clinical Significance of Variations in Adenosine Transfer Function on Coronary Flow.
timeFrame: 6-12 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: UCONN Health Center
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Michael A Azrin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut
name: Bruce T Liang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01693809: The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy Subjects
Official title: The Effects of Caffeine on Vestibular Evoked Myogenic Potentials in Healthy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Healthy Subjects
Keywords: Caffeine
Vestibular Evoked Myogenic Potentials
dizziness
vertigo
tinnitus
Lead sponsor: Hospital do Servidor Publico Estadual
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The principal aim of this study is to evaluate the presence of changes in cervical vestibular evoked myogenic potentials (VEMPc) after acute intake of caffeine in healthy subjects.

Secondarily, it wants to standardize normal values exam VEMPc in otorhinolaryngology service of the hospital.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* hearing impairment
* caffeine abuse 24 hours before the test
* medication remains
* hypertension, dyslipidemia, diabetes mellitus or sleep disorders.

Primary outcomes:
measure: Alteration of p13 and n23 latency and p13-n23 amplitude before and after caffeine intake.
timeFrame: 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Servidor Publico Estadual
Study officials:
affiliation: Hospital do Servidor Publico Estadual
name: Fabio Akira Suzuki, PhD
role: STUDY_CHAIR
affiliation: Hospital do Servidor Publico Estadual
name: Ana Maria Almeida Sousa, MD
role: PRINCIPAL_INVESTIGATOR
References: