louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03411655: Ambu® Aura-ITM Versus Ambu Aura GainTM for Fiberoptic Intubation in Children
Official title: A Randomised Non Crossover Study Comparing Ambu® Aura-ITM and Ambu® Aura GainTM for Fiberoptic Intubation in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: Medical University Innsbruck
First posted: 2018-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators test the hypothesis that fiberoptic intubation (time and success rate) differ between the Ambu® Aura-ITM and Ambu Aura GainTM in paralyzed anaesthetized pediatric patients


Eligibility criteria: Inclusion Criteria:

* ASA I-II
* age 1.5 - 6 years
* minor surgery
* extraglottic airway device

Exclusion Criteria:

* age (\<18 months, \>6 years)
* weight (\<10 kg, \>20 kg)
* a known difficult airway
* risk of aspiration

Primary outcomes:
measure: Fiberoptic intubation
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02541955: Use of Acthar in Rheumatoid Arthritis (RA) Related Flares
Official title: Use of Acthar in Rheumatoid Arthritis Related Flares
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis (RA)
Keywords: Rheumatoid arthritis (RA)
Musculoskeletal ultrasound (MSUS)
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a Rheumatoid Arthritis (RA) study. The purpose of this research study is to determine in RA flare, whether musculoskeletal ultrasound (MSUS) inflammatory scores and/or disease activity scores improve with Acthar treatment.

Detailed description: Participants with active RA flair will be assigned to take on one of two Acthar doses, either 40 units per week or 80 units twice a week. Both arms will be taking the drug for 4 weeks. Each participant will be coming back for visits at 2 weeks, 1 month and 3 months after the initial baseline visit. During these visits the following information will be collected: MSUS of joints, DAS28, Clinical Disease Activity Index (CDAI), Routine Assessment of Patient Index Data 3 (RAPID3) and Health Assessment Questionnaire-Disability Index (HAQ-DI). Participants will also be asked to fill out a questionnaire about their health status.

Efficacy of Acthar to decrease evidence of MSUS synovitis and disease activity measures will be analyzed using the above mentioned instruments, as well as Acthar's ability to prevent the necessity to change patients' RA treatment regimen.

Eligibility criteria: Inclusion Criteria:

1. Patient must meet 1987 ACR criteria
2. Age \> 18 years of age
3. Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) \>=3.2
4. Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs)
5. Stable prednisone \<10mg or equivalent
6. Power Doppler score of \>=10

Exclusion Criteria:

1. Prior treatment with Acthar in the past 2mos
2. Meet one of the above RA flare requirements
3. Subjects who have received live or live attenuated vaccines within 6 weeks prior to the first dose of study drug (or the zoster vaccine)

Primary outcomes:
measure: Ultrasound Power Doppler Score
timeFrame: Baseline to 2 Weeks
measure: DAS28
timeFrame: Baseline to 2 Weeks
Secondary outcomes:
measure: Ultrasound Grey Scale Synovial Hypertrophy score
timeFrame: Baseline to 2 Weeks
measure: HAQ-DI
timeFrame: Baseline to 4 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA David Geffen School of Medicine, Division of Rheumatology
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Veena K Ranganath, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01392755: A Study to Evaluate The Effects of Two Different Meal Types, Omeprazole And Ranitidine On Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Volunteers
Official title: A Study to Evaluate the Effects of Two Different Meal Types, Omeprazole and Ranitidine on Danoprevir Pharmacokinetics When Coadministered With Ritonavir in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This randomized, open-label study will evaluate the effect of food, and the effect of omeprazole and ranitidine on danoprevir co-administered with ritonavir. Volunteers will be assigned to one of two treatment groups. Volunteers in both groups will receive oral doses of danoprevir and ritonavir. In addition, volunteers in group 2 will receive oral doses of omeprazole and ranitidine. The anticipated time of the study is approximately 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult healthy volunteers, aged 18 to 45 years, inclusive
* Weight \>/= 50.0 kg
* Body Mass Index (BMI) 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

* Presence of any active or chronic disease
* Abnormal blood pressure
* Abnormal resting heart rate
* Abnormal ECG values
* History of any clinically significant cardiovascular or cerebrovascular disease
* Current smokers or subjects that have discontinued smoking \< 6 months prior to first dose of study drug
* Positive for hepatitis B, hepatitis C or HIV
* Positive test for drugs of abuse or alcohol
* Positive result for H. pylori
* Regular use of antacids, H-2 blockers, proton pump inhibitors, or any investigational drug within 30 days of first dose of study medication
* History of clinically significant gastrointestinal disease

Primary outcomes:
measure: Effect of omeprazole on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
timeFrame: 1 day
measure: Effect of ranitidine on the area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
timeFrame: 1 day
measure: Food effect on area under the plasma concentration time curve of danoprevir when co-administered with ritonavir
timeFrame: 1 day
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: Approximately 6 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03267355: Indications and Outcomes of Endoscopic Ultrasound in Tanta
Official title: Indications and Outcomes of Gastrointestinal Endoscopic Ultrasound in Tanta-Egypt: Initial Experience.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Disease
Intestinal Disease
Pancreatic Diseases
Esophageal Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim is to evaluate the initial experience for the indications and outcomes of EUS in Tanta university hospital.

Detailed description: Detection of main causes for referral to EUS in Tanta, Egypt.

Eligibility criteria: Inclusion Criteria:

* All cases of gastrointestinal EUS

Exclusion Criteria:

* Missed data

Primary outcomes:
measure: Number of different indications for Endoscopic Ultrasound in Tanta, Egypt
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tanta university hospital
Study officials:
affiliation: Tanta University Faculty of Medicine
name: Asem Elfert, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta university Faculty of Medicine
name: Ferial El-kalla, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanta University Faculty of Medicine
name: Samah Mosaad, consultant
role: STUDY_DIRECTOR
affiliation: Tanta University Faculty of Medicine
name: Walaa Elkhalawany, Consultant
role: STUDY_DIRECTOR
affiliation: Tanta University Faculty of Medicine
name: Reham Elkhouly, Consultant
role: STUDY_CHAIR
affiliation: Tanta University Faculty of medicine
name: Eslam Saber, Specialist
role: STUDY_CHAIR
References:
Clinical trial NCT01546155: The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
Official title: The Influence of Pressure Pain on [11C]Diprenorphine Binding Potentials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Controls
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Healthy volunteers aged 21 to 50 are needed for a research study investigating whether pain will alter the binding properties of (\[11C\]diprenorphine), a molecule that can be used during brain imaging. Positron Emission Tomography (PET) and functional Magnetic Resonance (fMRI) imaging will be used in this study.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults, 21 to 50 years of age
* No contraindications to fMRI and PET scanning
* Within 15% of ideal body mass index (BMI)

Exclusion Criteria:

* Current significant medical, neurological, or psychiatric illness as assessed by the Physician Investigators
* Women who are pregnant or breast feeding, have gone through menopause, and/or have irregular menstrual cycles
* Claustrophobia
* History of head trauma
* Instability of responses to experimental pain (See Study Procedure Section Part II)
* History of asthma
* Use of psychotropic drugs or hormone treatments (including hormonal birth control) within one year of date of consent
* History of smoking
* Routine exercise in excess of one hour per day and/or three times per week
* Non-fluent English speaker

Primary outcomes:
measure: PET/MRI Brain Activation
timeFrame: day one
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jian Kong, MD (equiv), MS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01651455: Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000
Official title: Maintaining Lung Function in Cystic Fibrosis Patients: Evaluation and Comparison Between Two Decades in a Retrospective Monocentric Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Pseudomonas Aeruginosa
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Medidata Solutions
First posted: 2012-07-27
Enrollment: 92
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients affected with Pseudomonas A. living in the N-E area of Italy.

Brief summary: The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.

Detailed description: The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in terms of FEV1 maintenance from the age of 10 to 15 before and after 2000.

Eligibility criteria: Inclusion Criteria:

* Patients with Cystic Fibrosis diagnosed with neo-natal screening
* Patients born between 01/01/1979 and 12/31/1984 (Cohort 1)and patients born between 01/01/1991 and 12/31/1996 (Cohort 2)
* Patients with at least 2 FEV1 yearly measurements from the age of 10 to 15

Exclusion Criteria:

* Patients with malignant tumor
* Patients with meconium ileus
* Patients with transplantation (pneumectomy or lobectomy)
* Patients involved in any other clinical trial
* Patients moved to another Clinical Center

Primary outcomes:
measure: To describe the difference in terms of FEV1 decline between two cohorts of cystic fibrosis patients
timeFrame: 5 years
Secondary outcomes:
measure: To identify clinical parameters or treatments correlated to FEV1 maintenance in two cohorts of cystic fibrosis patients
timeFrame: 5 years
measure: To evaluate the number of patients with Pseudomonas Aeruginosa infection during observational period
timeFrame: 5 years
measure: To describe length of time without Pseudomonas A. infection in non-colonized patients during observational period.
timeFrame: 5 years
Other outcomes:
Locations:
city: Verona
country: Italy
facility: U.O. Azienda Ospedaliera
state: Veneto
Study officials:
affiliation: U.O. Fibrosi Cistica Azienda Ospedaliera Verona
name: Baroukh Maurice Assael, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02630355: Remote Ischaemic Preconditioning to Prevent Dialysis Induced Cardiac Injury
Official title: Randomized Controlled Trial of Remote Ischaemic Preconditioning to Protect Against Dialysis Induced Cardiac Injury in Haemodialysis: Low Vs. High Intensity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hemodialysis
Cardiovascular Diseases
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
First posted: 2015-12-15
Enrollment: 32
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 study evaluates the use of remote ischaemic preconditioning for the prevention of dialysis induced cardiac injury. The study uses four arms to test different frequencies of application to ascertain which, if any, is most successful at reducing dialysis induced cardiac injury.


Eligibility criteria: Inclusion Criteria:

1. Patients having haemodialysis treatment at least 3 times per week at a London Health Sciences Centre facility
2. Male and female, age≥16 years old.

Exclusion Criteria:

1. Not meeting inclusion criteria
2. Exposure to haemodialysis for \<90 days prior to recruitment
3. Severe heart failure (New York Heart Association grade IV)
4. Cardiac transplant recipients
5. Mental incapacity to consent
6. Declined to participate
7. Taking cyclosporin
8. Taking ATP-sensitive potassium channel opening or blocking drugs

Primary outcomes:
measure: The primary outcome will be a reduction in the number of left ventricular segments undergoing a greater than 30% reduction in longitudinal strain as detected by echocardiography at final study visit
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of segments undergoing >30% reduction in longitudinal strain at intervention, week 1, week 2 and week 3 visits
timeFrame: up to 3 weeks
measure: Difference between pre and peak global longitudinal strain at intervention, week 1, week 2 and week 3 visits
timeFrame: up to 3 weeks
measure: Change in pre-dialysis global longitudinal strain between baseline and final study visit
timeFrame: between 1 and 4 weeks
measure: Change in Troponin-T, Plasma IL-6 and N-Type proBNP at intervention, first follow-up and final visit
timeFrame: up to 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04736355: DAOIB for the Treatment of Mild Cognitive Impairment
Official title: DAOIB for the Treatment of Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 88
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: NMDA neurotransmission plays an important role in learning and memory. NMDA receptor-enhancing agent improved the cognitive function of patients with early-phase Alzheimer's disease. This study is a randomized, double-blind, placebo-controlled drug trial. All subjects will be allocated randomly to 2 groups: (1) DAOIB group; (2) placebo group. The study period is 24 weeks. The investigators hypothesize that DAOIB may yield better efficacy than placebo for cognitive function in patients with mild cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild cognitive impairment
* MMSE between 17-26
* CDR 0.5

Exclusion Criteria:

* Hachinski Ischemic Score \> 4
* Substance abuse/dependence
* Parkinson disease, epilepsy, dementia with psychotic features
* Major psychiatric disorders
* Major physical illnesses
* Severe visual or hearing impairment

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
timeFrame: week 8, 16, 24
measure: Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Medical Outcomes Study Short-Form-36 (SF-36) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in the composite score of a battery of additional cognitive tests at week 8, 16 and 24
timeFrame: week 0, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT06778655: Propolis in Primary Herpetic Gingivostomatitis
Official title: Propolis in Management of Primary Herpetic Gingivostomatitis Measuring the Level of INF-γ in Saliva. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herpetic Gingivostomatitis
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2025-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to investigate the efficacy of 5% propolis gel in the treatment of primary herpetic gingivostomatitis in children and its effect on salivary IFN-γ levels.


Eligibility criteria: Inclusion Criteria:

* clinical manifestations suggestive of PHGS
* positive culture for HSV-1

Exclusion Criteria:

* negative culture for HSV-1
* allergic to honey or its products
* patients diagnosed with any systemic diseases, immunosuppressed or immunocompromised patients

Primary outcomes:
measure: The severity of oral lesions
timeFrame: one week
Secondary outcomes:
measure: Pain
timeFrame: one week
measure: measurement of salivary INF-γ level
timeFrame: one week
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: fayoum University
Study officials:
affiliation: Fayoum University
name: Rania Shalaby, associate professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06179355: Limbal Astigmatic Keratotomy to Correct High Degrees of Astigmatism After Phacoemulsification
Official title: Comparison Between Manual Limbal Astigmatic Keratotomy and Femtosecond Laser-guided Limbal Astigmatic Keratotomy for Correction of Astigmatism More Than Three Diopters After Phacoemulsification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare manually performed Astigmatic Keratotomy to femtosecond laser astigmatic keratotomy to manage corneal astigmatism more than three diopters after phacoemulsification.

Detailed description: create circumferential corneal incisions, following the limbal curvature, at 1-1.5 mm anterior to the limbus, manually and by using femtosecond laser to correct corneal astigmatism more than three diopters after phacoemulsification.

Eligibility criteria: Inclusion Criteria:

* Possibility to have informed consent and attendance of all study visits.
* Patients who have undergone conventional phacoemulsification at least one month ago.
* Clear cornea.
* Astigmatism more than 0.5 diopters.

Exclusion Criteria:

* Corneal opacity.
* History of corneal surgery.
* Thin cornea.
* Astigmatism equal to or less than 0.5 diopters.

Primary outcomes:
measure: astigmatism (Keratometric reading)
timeFrame: three month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Assiut University
Study officials:
affiliation: assiut univrsity
name: Ashraf Rashwan, MD
role: PRINCIPAL_INVESTIGATOR
References: