louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03063359: Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma
Official title: Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain, Acute
Keywords: traumatic pain
children
fentanyl
intranasal use
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 22
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.

To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.

The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 4 years old and 15,3 years old
* Acute pain in traumatic context with a suspicion of fracture for patient \<7years old : feeling Pain \>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not \<10 points)
* For patients \>7 years old : feeling pain \>6 points and defined thanks to a visual analogic scale
* Informed consent form signed by parents
* Beneficiary of an european health protection

Exclusion Criteria:

* Antalgic ( II or III) within 4 hours before the inclusion
* Allergic or non-indication of fentanyl
* Allergic or contraindication of morphine sulfate
* Pre existing peripheral intravenous catheter
* Traumatic brain injury
* Nasal traumatic

Primary outcomes:
measure: Assessment of the value of the pain feeling
timeFrame: 45 minutes
Secondary outcomes:
measure: Delay in treatment efficacy
timeFrame: up to 45 minutes
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: Montpellier University Hospital
name: Gaël GG GUYON, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01392859: Characterization of the Role of Histamine in Children With Asthma
Official title: Characterization of the Role of Histamine in Children With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Allergic Asthma
Non-allergic Asthma
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2011-07-13
Enrollment: 211
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Asthma, a chronic disease which produces significant morbidity and mortality in children, is a significant health problem to a large segment of society. Despite considerable advances in the diagnosis and treatment of asthma over the past several years, a sizeable portion of patients do not respond to the "core" treatments. The investigators are now learning that the underlying pathophysiology of disease is different among patients with asthma therefore; treatments which are beneficial in some patient groups may be not achieve affect in other groups.

Antihistamines have been studied in the past for the treatment of asthma. These studies have shown that there may be a beneficial effect of antihistamines in patients with allergic asthma where histamine likely plays a large role in disease and treatment response. However, there is not enough evidence to include these drugs in the standard treatment of asthma.

The investigators hypothesize that histamine plays a definable, significant role in disease pathogenesis and treatment response in children with allergic asthma. The investigators plan to test this overall hypothesis through two specific aims. The first aim will characterize the relative contribution of histamine in allergic vs. non-allergic asthma. This aim will be accomplished by comparison of the microvasculature response to histamine in children with allergic asthma and children with non-allergic asthma, measured by histamine iontophoresis with laser Doppler (HILD) monitoring, to determine potential phenotype-associated differences in the pharmacodynamic response to histamine.


Eligibility criteria: Inclusion Criteria:

* children age 7-17 years old
* with the diagnosis of allergic asthma or non-allergic asthma (n=102

Exclusion Criteria:

* history of immunodeficiency, mastocytosis
* chronic abnormal conditions of the skin, liver or kidney
* neoplastic disease
* movement or neurologic disorders
* active eczema on the forearms at the time of study
* history of a previous anaphylactic episode
* evidence of pregnancy (by urinary hCG) or lactation at the time of the study

Primary outcomes:
measure: Characterize Contribution of Histamine in Children With Asthma
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital and Clinics
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital and Clinics
name: Bridgette L. Jones, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06299059: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients
Official title: Intermittent Oro-esophageal Tube on Rehabilitation Therapy Compliance in Stroke Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2024-03-07
Enrollment: 80
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: TREATMENT

Brief summary: The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

Detailed description: The study will last 15 days for each participant. The aim of this clinical trial is to compare Rehabilitation Therapy Compliance of ischemic stroke patients who receive enteral nutrition support through either Intermittent Oro-esophageal Tube or Nasogastric Tube. Patients will be randomly assigned to either an observation group or a control group, with both groups receiving routine rehabilitation treatment. The observation group will receive enteral nutrition support through Intermittent Oro-esophageal Tube, while the control group will receive it through Nasogastric Tube. Researchers will then compare Rehabilitation Therapy Compliance of the two groups.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* damaged mucosa or incomplete structure in nasopharynx;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.

Primary outcomes:
measure: Rehabilitation Treatment Compliance Questionnaire
timeFrame: day 1 and day 15
Secondary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: day 1 and day 15
measure: Swallowing Quality of Life questionnaire
timeFrame: day 1 and day 15
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Nieto Luis, Master
role: STUDY_DIRECTOR
References:
Clinical trial NCT05420259: Combined Exercise and Nutritional Intervention in GI Cancer Patients
Official title: Influence of a Combined Dietary and Exercise Intervention on Cytokine Profile and NK Cell Activation in Cancer Patients Undergoing Neoadjuvant Treatment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Gastric Cancer
Diet
Exercise
Keywords: Body composition
Wasting
Malnutrition
Lead sponsor: Hospital Beatriz Ângelo
Sponsor class: OTHER
First posted: 2022-06-15
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Although some studies have focused on the role of exercise on inflammation and cytokine expression in cancer patients undergoing treatment and survivors, to our knowledge none have investigated the effect of exercise during neoadjuvant treatment as a complementary therapy to 1) modulate inflammation which may have a positive influence on chemotherapy response and 2) preserve or improve skeletal muscle, thus preventing cancer cachexia. Furthermore, we believe that the neoadjuvant treatment period could be a window of opportunity to optimize patient's nutritional status before surgery, which until now has been under used.

Bearing in mind that nutritional interventions may also influence IL-6, our hypothesis is that a Combined Exercise and Dietary Intervention (CEDI) may induce positive alterations in cytokine profile and increase NK cell infiltration of the tumor in gastric and pancreatic cancer patients submitted to neo-adjuvant therapy.


Eligibility criteria: Inclusion Criteria:

* gastric or pancreatic cancer stage II/III, eligible for neoadjuvant chemotherapy,
* age higher than 40 years and lower than 80 years,
* ECOG (Eastern Cooperative Oncology Group) functional status: 0-2,
* sedentary/low physical activity level.

Exclusion Criteria:

* life expectancy less than 12 months at inclusion,
* chemotherapy regimen other than 5-Fluorouracil, Folinic acid, Oxaliplatin, Docetaxel (FLOT) for gastric and 5-Fluorouracil, Irinotecan and Oxaliplatin (FOLFIRINOX) or gemcitabine for pancreatic cancer,
* metastatic disease,
* chronic anti-inflammatory medication use,
* known inflammatory condition (rheumatoid arthritis, ankylosing spondylitis or chronic active hepatitis)
* cardiovascular, respiratory or musculoskeletal or joint problems that preclude moderate physical activity.

Primary outcomes:
measure: Mean Change in interleukin 6 (IL6)
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Immune cell infiltration profile on tumor specimen
timeFrame: 8 weeks
measure: Change in skeletal muscle
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
state: Lisboa
city: Lisboa
country: Portugal
facility: Hospital da Luz
Study officials:
affiliation: Hospital da Luz
name: Marilia Cravo
role: STUDY_DIRECTOR
References:
Clinical trial NCT06757959: Effectiveness of Wet Needling Technique in Patients of Patellofemoral Pain Syndrome
Official title: Effectiveness of Wet Needling Technique in Patients of Patellofemoral Pain Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Patellofemoral Pain Syndrome
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 36
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study evaluate the effectiveness of wet needling technique in reducing pain, improving function and enhancing the quality of life in patellofemoral pain syndrome patient.Patellofemoral pain syndrome is a common knee condition that significantly affects physical activity and quality of life .

Detailed description: This study aims to determine wether integrating wet needling into a kinesiotaping and strenghthening exercises regimen provides enhanced outcomes for patellofemoral pain syndrome patients .Wet needling combined with kinesiotaping and strengthening eexercises provides superior pain relief and functional improvement .Participant will divided into two groups : one will recieve treatment using wet needling with kinesiotaping and strengthening exercises , and the other recieve kinesiotaping and strengthening exercises.

Eligibility criteria: Inclusion Criteria:

* Age between 20-35
* unilateral , prepatellar or retropatellar pain unrelated to trauma for atleast 3 month , agerevated witrh atleast 2 daily activities such as prolonged sitting, squatting , kneeling , running or stairs climbing.
* Positive clarkes sign.
* Average pain in the previous week \>3 on numeric pain rating scale. Kujala questionnaire score \<85of 100.
* Active trigger points in gluets and quadriceps.
* Presence of palpable taut band in muscle and typical reffered pain .

Exclusion Criteria:

* Bilateral anterior knee pain.
* Patients with fracture of knee joint , dislocation of patella , previous knee or ankle surgery and ligament or meniscus injury .
* Marked structural deformity and known pathological condition of back , hip and ankle . Any metabolic or neurological disease such as diabetes or radicular pain . Physical therapy for knee pain within the previous year .

Primary outcomes:
measure: Numeric rating pain scale (NRPS )
timeFrame: 12 Months
measure: Kujala score
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sahiwal
country: Pakistan
facility: Medsol medical solutions sahiwal, Street between qureshi and total pump , mall mandi chowk
state: Punjab
Study officials:
References:
Clinical trial NCT05512559: Body Composition Analysis and Time to Emergence From Remimazolam
Official title: Value of Body Composition Analysis in Predicting Delayed Emergence From Remimazolam-based General Anesthesia: A Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Remimazolam
Body Composition
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam

Brief summary: Remimazolam is a novel general anesthetic drug. The time to emergence from remimazolam-based general anesthesia is variable among patients, but little is known about the risk factors for delayed emergence. We believe that information from body composition analysis may be helpful in understanding which patients are more likely to show delayed emergence from remimazolam.


Eligibility criteria: Inclusion Criteria:

* Adult ASA I-III patients undergoing cerebral aneurysm coil embolization under general anesthesia using remimazolam

Exclusion Criteria:

* Patients with preoperative mental change, hemodynamic instability, hemodialysis, heart failure, hypoalbuminemia, pregnancy

Primary outcomes:
measure: emergence time
timeFrame: at the time of emergence
Secondary outcomes:
measure: time to loss of consciousness
timeFrame: at the time of induction
measure: hypotension
timeFrame: from induction to emergence of anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University, School of Medicine
Study officials:
References:
Clinical trial NCT00854659: A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study of the Safety, Tolerability and Pharmacokinetics of ABT-102 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-03-03
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of three different strengths of an investigational product dosed twice a day over 7 days in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Males and Females with a condition of general good health.
* Must be willing to participate in all study-related procedures.

Exclusion Criteria:

* History of significant sensitivity to any drug.
* Allergy to soy lecithin, soybeans, soybean oil, or other soybean derivatives.
* A requirement for medications, vitamins and/or herbal supplements during the study.
* Pregnant or breast-feeding.
* History of drug or alcohol abuse.
* Positive Hepatitis or HIV test.
* History of certain medical conditions or any uncontrolled medical illness.
* History of certain gastrointestinal surgeries that may interfere with gastrointestinal motility, PH or absorption.
* Current participation in another clinical study or receipt of investigational drug within the past 6 weeks.

Primary outcomes:
measure: To determine the safety and tolerability of ABT-102 vs placebo in healthy adults.
timeFrame: 10 days
measure: To determine the plasma concentrations and pharmacokinetic parameters of multiple does of ABT-102 vs. placebo in healthy adults.
timeFrame: 10 days
Secondary outcomes:
measure: Exploratory analyses of Quantitive Thermosensory Testing (Warm Detection Threshold, Cold Detection Threshold, Warm Pain Threshold) done at peripheral and oral sites, will be done for ABT-102 and placebo treated subjects.
timeFrame: 10 days
Other outcomes:
Locations:
city: Austin
country: United States
facility: Site Reference ID/Investigator# 18101
state: Texas
Study officials:
References:
citation: Rowbotham MC, Nothaft W, Duan RW, Wang Y, Faltynek C, McGaraughty S, Chu KL, Svensson P. Oral and cutaneous thermosensory profile of selective TRPV1 inhibition by ABT-102 in a randomized healthy volunteer trial. Pain. 2011 May;152(5):1192-1200. doi: 10.1016/j.pain.2011.01.051. Epub 2011 Mar 4.
Clinical trial NCT00437970: Medication in Early Diabetes (MED) Study
Official title: Drug naïve Indigenous Australians With Type 2 Diabetes, Enrolled in a Randomised Controlled Trial of Rosiglitazone Versus Metformin Monotherapy to Assess the Effects on Metabolic and Cardiovascular Parameters
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
First posted: 2007-02-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares metformin (current first-line medication) to pioglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of pioglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further assessment is required in Indigenous Australians (in whom there is a strong predisposition for central fat deposition). This study will provide evidence regarding the medication appropriate for first line medication in Type 2 diabetes in this high risk population. This study will assist clinicians to make evidenced-based decisions regarding initial medical management of those with Type 2 diabetes (where there is currently a gap in evidence).


Eligibility criteria: Inclusion Criteria:

* Drug naïve Indigenous Australians with Type 2 Diabetes
* Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commences
* Participants must be able to give informed voluntary consent
* Both males and females (females of child bearing potential excluded if not on reliable means of contraception)

Primary outcomes:
measure: HbA1c values
timeFrame: second monthly
measure: Weight gain
timeFrame: monthly
measure: Weight distribution
timeFrame: six monthly
measure: Medication side effects
timeFrame: monthly
Secondary outcomes:
measure: Medication compliance
timeFrame: monthly
measure: Side effects
timeFrame: monthly
measure: Lipids
timeFrame: second monthly
measure: Endothelial dysfunction.
timeFrame: second monthly
Other outcomes:
Locations:
city: Darwin
country: Australia
facility: Menzies School of Health Research
state: Northern Territory
Study officials:
affiliation: Menzies School of Health Research
name: Louise Maple Brown, MBBS PhD FRACP
role: PRINCIPAL_INVESTIGATOR
References: