louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06368219: Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting
Official title: Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Procedural Sedation
Keywords: midazolam
propofol
ketamine
procedural sedation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:

* Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
* Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.

the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥18 years) requiring procedural sedation and analgesia for painful procedures in ED . The following procedures are indications for PSA:
* Cardioversion
* Reduction of fracture or joint dislocation
* Procedures as central venous catheter (CVC) and chest tube insertion or wound management

Exclusion Criteria:

* Patients with anticipated difficult airway.
* Post cardiac arrest patients.
* Contraindication to study drugs.
* Pregnant women.
* Patients \> 65 years.

Primary outcomes:
measure: Induction and recovery time for both combinations
timeFrame: 2 hours
Secondary outcomes:
measure: incidence and severity of adverse events
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06230419: Retrospective Study on the Direction of Artificial Intelligence in Identifying Cranial Trauma CT Imaging
Official title: Evaluation of Artificial Intelligence's Ability to Analyze and Recognize Cranial Trauma CT Imaging
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cerebral Hemorrhage
Keywords: Artificial Intelligence
Computed Tomography
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 208
Sex: ALL
Minimum age (years): 16
Maximum age (years): 92
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population ranges from 16 years old to 92 years old, both female and male, who mostly are the elderly.

Brief summary: The goal of this observational retrospective study is to evaluate artificial intelligences (AI)'s proficiency in identifying and annotating brain bleeds in computed tomography (CT) images.

The main questions it aims to answer are:

* Whether AIs at present are capable of analyzing and recognizing cerebral traumas in CT images?
* If they are, how competent are they and how can humans take advantages of that? CT images were selected during the normal diagnosis and treatment process of patients, and no one needed to undergo any additional procedures connected to the study.


Eligibility criteria: Inclusion Criteria:

* People who had cerebral traumas with brain bleedings shown in CT images.

Exclusion Criteria:

* Brain bleedings were not clear or representative in CT images.

Primary outcomes:
measure: The identification completeness of the annotated images.
timeFrame: 1 months
Secondary outcomes:
measure: The evaluations from professionals for outcomes produced by AIs
timeFrame: 1 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT06547619: Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Official title: Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Gestational Diabetes
Endothelial Dysfunction
Physical Inactivity
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Women with a history of gestational diabetes mellitus (GDM) are at a 2-fold greater risk for the development of overt cardiovascular disease (CVD) following the effected pregnancy. While subsequent development of type II diabetes elevates this risk, prior GDM is an independent risk factor for CVD morbidity, particularly, within the first decade postpartum. GDM is associated with impaired endothelial function during pregnancy and decrements in macro- and microvascular function persist postpartum, despite the remission of insulin resistance following delivery. Collectively, while the association between GDM and elevated lifetime CVD risk is clear, and available evidence demonstrates a link between GDM and vascular dysfunction in the decade following pregnancy, the mechanisms mediating this persistent dysfunction remain unexamined.

The purpose of this investigation is to examine the role of endothelin-1, a potent vasoconstrictor, in aberrant microvascular function in otherwise healthy women with a history of GDM and to identify whether this mechanism is influenced by physical activity and sedentary behavior.


Eligibility criteria: INCLUSION CRITERIA

* history of pregnancy within 5 years of the study visit
* had healthy pregnancy OR had gestational diabetes diagnosed by their obstetrician and confirmed according to the American College of Obstetricians and Gynecologists criteria for gestational diabetes.

EXCLUSION CRITERIA

* skin diseases,
* current tobacco or electronic cigarette/vape pen use,
* diagnosed or suspected hepatic or metabolic disease including diabetes,
* statin or other cholesterol-lowering medication,
* current antihypertensive medication,
* history of preeclampsia or gestational hypertension
* current hypertension,
* current pregnancy,
* body mass index \<18.5 kg/m2,
* allergy to materials used during the experiment.(e.g. latex), known allergies to study drugs.

Primary outcomes:
measure: amount of microvascular insulin-mediated dilation
timeFrame: at the study visit, an average of 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References:
Clinical trial NCT00316719: Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
Official title: Phase III Study of Adefovir Dipivoxil Tablets in Patients With Compensated Chronic Hepatitis B -Comparative Study Against Lamivudine-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Keywords: treatment naive
CHB
adefovir
monotherapy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-04-21
Enrollment: 105
Sex: ALL
Minimum age (years): 16
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to compare the efficacy and safety of adefovir dipivoxil 10 mg with lamivudine 100 mg in Japanese patients with compensated chronic hepatitis B over 52-week periods.


Eligibility criteria: Inclusion criteria:

* Have compensated chronic hepatitis B.
* Have not been treated with anti HBV agents with antiproliferative activity against. However, previous Interferon (IFN) therapy is permitted.
* Ability to read, understand, and sign the informed consent.
* Have a positive serum HBV-DNA \>= 1,000,000 copies/mL and ALT level 50-500 U/L

Exclusion criteria:

* Having or suspected of having liver cancer.
* Co-infected with Hepatitis C virus (HCV) or Human Immunodeficiency virus (HIV).
* Autoimmune hepatitis.
* Received any previous transplantation or having a plan for any transplantation.
* Existence of any serious complication, except hepatitis B.

Primary outcomes:
measure: Mean Change From Baseline in Hepatitis B Virus (HBV) DNA at Week 52
timeFrame: Baseline and Week 52
Secondary outcomes:
measure: Percentage of Participants With HBV DNA Loss (<400 Copies/mL) at Week 52
timeFrame: Week 52
measure: Time to Onset of HBV DNA Loss (< 400 Copies/mL)
timeFrame: From Baseline to Week 52
measure: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Hepatitis B e Antigen/Antibody (HBeAg/Ab) Seroconversion at Week 52
timeFrame: Week 52
measure: Time to Onset of HBeAg Loss
timeFrame: From Baseline to Week 52
measure: Time to Onset of HBeAg/Ab Seroconversion
timeFrame: From Baseline to Week 52
measure: Percentage of Participants With Hepatitis B s Antigen (HBsAg) Loss at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Hepatitis B s Antigen/ Antibody (HBsAg/Ab) Seroconversion at Week 52
timeFrame: Week 52
measure: Mean Alanine Aminotransferase (ALT) Level at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Alanine Aminotransferase (ALT) Normalization at Week 52
timeFrame: Week 52
measure: Time to Onset of ALT Normalization
timeFrame: From Baseline to Week 52
measure: Rate of Emergence of Resistant Virus at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01686919: Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity
Official title: Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity, Morbid
Keywords: Gastric bypass
Questionnaires
Diet
Milk
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
First posted: 2012-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in Hedmark og Oppland, Norway. Patients with either BMI \> 40 kg/m2 or with BMI \> 35 kg/m2 and complications who opt for "gastric bypass" surgery, go through a standard program including a thorough clinical examination and information on the operation, followed by a learning and coping program that consists of standard dietary advise for weight loss and includes weekly visits during 8 weeks.

This research project concerns a subgroup in the patient population described above: morbidly obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is known that milk may cause stomach complaints and may make it more difficult to loose weight.


Eligibility criteria: Inclusion Criteria:

* morbid obesity

Exclusion Criteria:

* no consent
* contraindications to surgery

Primary outcomes:
measure: weight loss
timeFrame: 8 weeks
Secondary outcomes:
measure: Gastrointestinal symptoms
timeFrame: 8 weeks
measure: IgG antigen against milk
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Per Farup, MD prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT06816719: To Evaluate the Safety and PK Characteristics in Healthy Volunteers-JW24107
Official title: A Randomized, Open-label, Single Dose, 2x4 Crossover Study to Evaluate the Safety and Pharmacokinetic Characteristics After Co-administration of JW0106 and C2101 and Administration of JW0107 in Healthy Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-02-10
Enrollment: 47
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0106 and C2101 and administration of JW0107 in healthy volunteers under fasting conditions.

Detailed description: Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Eligibility criteria: Inclusion Criteria:

Healthy volunteers

Exclusion Criteria:

Subjects does not meet the inclusion Criteria

Primary outcomes:
measure: AUCt
timeFrame: Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)
measure: Cmax
timeFrame: Day 1(0 hour~12 hour), Day 2(24 hour), Day 3(48 hour), Day 4(72 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center, Jeonbuk National University Hospital
state: Korea
Study officials:
References:
Clinical trial NCT00368719: Evaluation to Assess the Long Term Safety of Tacrolimus Ointment for Atopic Dermatitis
Official title: APPLES: A Prospective Pediatric Longitudinal Evaluation To Assess The Long Term Safety Of Tacrolimus Ointment For The Treatment Of Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Atopic Dermatitis
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2006-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the long-term safety of tacrolimus ointment

Detailed description: To assess the long-term safety of tacrolimus ointment 0.03% or 0.1% in the treatment of subjects with atopic dermatitis under actual use conditions, including the risk of developing cutaneous or systemic malignancies. The FDA and EMEA approved Tacrolimus ointment, 0.03% in children and 0.1% and 0.03% in adults, for the treatment of atopic dermatitis. As part of the approval process, the FDA and EMEA requested a post-marketing commitment regarding the safety of long-term use of Tacrolimus ointment in pediatric atopic dermatitis subjects.

Eligibility criteria: Inclusion Criteria:

* Subject has/had atopic dermatitis.
* Subject has applied tacrolimus ointment 0.03% or 0.1% for at least 6 weeks, continuously or intermittently. This may include subjects who have been enrolled in previous tacrolimus ointment studies and/or subjects with commercial product exposure prior to study enrollment.
* Subject age at the first tacrolimus ointment exposure is/was \<16 years of age.
* Subject/Caregiver has given written informed consent and assent as required by state and/or governmental laws, including access to all relevant clinical and medication data, and the storage and analysis of these data.
* Subject/Caregiver agrees to comply with the program requirements including an annual physical exam and biennial dermatological exam and agrees to be contacted and provide information as described in this document to Primary Investigator Dr. Lamb and Covance Periapproval Services, Inc.

Exclusion Criteria:

* Subjects who do not have/ have not had Atopic Dermatitis.
* Subjects must have used Tacrolimus ointment prior to age 16.

Primary outcomes:
measure: The purpose of this study is to identify the long term effects of Tacrolimus in pediatric subjects
timeFrame: 10 Years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Physician with UC Davis Department of Dermatology
name: Fu-Tong Liu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05927519: Comparison of Airtraq in Class 2-3 Obese and Nonobese Men During Intubation: a Prospective Randomized Clinical Study
Official title: Airtraq in Obese and Nonobese Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Intubation; Difficult or Failed
Video Laryngoscope
Men
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Airtraq video laryngoscope will be used in morbid obese and non obese patients
Primary purpose: DIAGNOSTIC

Brief summary: Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, perioperative hemodynamic variables, and postoperative complications will also be recorded.

Detailed description: Morbid obesity is a growing disease. Intubations of these patients mostly difficult. Video laryngoscopes have to be used during the intubation of these patients. The intubation of men is more complicated and difficult than obese women. There were no trials compared to the new video laryngoscopes in morbidly obese men. Patients will be divided into two groups; non-obese and klas 2-3 obese. Airtraq will be used for their intubation. The time for intubation will be the primary aim of this prospective randomized study. The insertion time, need of optimization menuvers, perioperative hemodynamic variables, and postoperative complications will also be recorded.

Eligibility criteria: Inclusion Criteria:\> 18 age men gender elective operation requring intuabtion -

Exclusion Criteria:\<18 age women emergency operation

-

Primary outcomes:
measure: intubation time
timeFrame: 50 seconds
Secondary outcomes:
measure: insertion time
timeFrame: 20 seconds
measure: peroperative hemodynamic variable
timeFrame: 4 hours
Other outcomes:
Locations:
city: Iamit
country: Turkey
facility: Kocaeli University Medical Faculty Hospital
city: Kocaeli
country: Turkey
facility: Kocaeli UniversityMedical Faculty
Study officials:
References:
Clinical trial NCT04701619: Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies (IMMUNOSTROKE)
Official title: Immuno-inflammatory Profile and Response to Ischemic Stroke Reperfusion Therapies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Ischemic Stroke
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-01-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients undergoing a reperfusion procedure as part of an ischemia stroke will be able to participate in the study.
Primary purpose: OTHER

Brief summary: IMMUNOSTROKE study aims to describe the immuno-inflammatory and thrombo-inflammatory profiles during the course of AIC management by reperfusion treatment and to monitor changes in these different parameters over time. Post-hoc analyses will make it possible to correlate the immuno-inflammatory and thrombo-inflammatory profiles and their evolution with the clinical outcome in terms of post-AIC functional and cognitive disability.


Eligibility criteria: Inclusion Criteria:

* Presenting an ISCHEMIC STROKE for which reperfusion treatment is indicated according to European and North American recommendations (intraveinous thrombolysis or mechanical thrombectomy or a combination of both)

Exclusion Criteria:

* Contraindication to performing a cerebral MRI (claustrophobia, pacemaker or other implantable device contraindicating the performance of MRI)
* Intracranial haemorrhage associated with AIC on initial imaging
* Immunosuppressive treatment or corticosteroid therapy on admission of the patient
* Pre-existing neurological disability limiting the neurological assessment to 3 months (mRS\>2 on admission)
* Dementia known and diagnosed pre-existing at ischemic stroke
* Absolute or relative contraindication to gadolinium injection (history of true allergic reaction or intolerance to gadobutrol, renal failure with creatinine clearance \<15mL/min, pregnant or breastfeeding woman).

Primary outcomes:
measure: Immuno-inflammatory profile description in patients with ischemic stroke and eligible for reperfusion treatment
timeFrame: Up to year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: