louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01043965: Myocardial Perfusion in Type 2 Diabetes
Official title: Evaluation of Myocardial Perfusion and Microvascular Reserve in Real-time Utilizing Myocardial Contrast Echocardiography in Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes
Keywords: Diabetes Mellitus
Myocardial perfusion imaging
Heart diseases
Echocardiography
Endothelium
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-01-07
Enrollment: 61
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries.

Myocardial blood flow reserve will be determined by quantitative contrast Stress echocardiography. Diabetic individuals will be evaluate in a decompensated state (Phase 1) and after optimization of medical treatment four months later (Phase 2).

Detailed description: Early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated with an impairment in endothelium-dependent dilation of the coronary microvasculature, indicating that the pathophysiological consequences of atherosclerosis may extend into the coronary microcirculation.

The investigators will evaluate three parameters of myocardial quantification with contrast Stress echocardiography and correlate with HbA1C levels.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Normal echocardiogram
* Absence of obstructive epicardial coronary disease

Exclusion Criteria:

* Obstructive coronary disease
* Heart valve disease
* COPD
* Cardiac Arrhythmias
* Cardiomyopathy

Primary outcomes:
measure: myocardial blood flow velocity, myocardial blood flow reserve
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Heart Institute - Sao Paulo - Brazil
name: Wilson Mathias Jr, Md, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01638065: A Comprehensive Look at Vascular Access
Official title: A Comprehensive Look at Vascular Access: Utilizing a Near Infrared Vein Visualization Device For Vascular Access Planning, Attempts, and Post Access
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Access
Keywords: vein identification
vascular access
Lead sponsor: Christie Medical Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 196
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients at a medical facility requiring IV access.

Brief summary: The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.


Eligibility criteria: Inclusion Criteria:

* Requires peripheral venous access
* Intact skin on areas of assessment
* Patient and/or parent or legal guardian is able to understand consent

Exclusion Criteria:

* No Intact skin
* Patient is under anesthesia during peripheral venous access
* Patient is not a suitable candidate, as determined by the discretion of the investigator

Primary outcomes:
measure: The primary endpoint will be total number of attempts for successful cannulation.
timeFrame: 1 day
Secondary outcomes:
measure: Amount of time for successful venous access
timeFrame: 1 day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: LA County Hospital
state: California
city: Downers Grove
country: United States
facility: Good Samaritan Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT01612065: Optimum Misoprostol Dose Prior to Office Hysteroscopy
Official title: The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Abnormal Uterine and Vaginal Bleeding, Unspecified
Recurrent Abortion
Keywords: Office hysteroscopy
Cervical priming
Misoprostol
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 132
Sex: FEMALE
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: Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.

Detailed description: The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications

Eligibility criteria: Inclusion Criteria:

* Female patient pre- or postmenopausal undergo office hysteroscopy.
* Age: from 20 to 60.
* BMI between 18 and 30.

Exclusion Criteria:

* PID or
* Heavy uterine bleeding
* Cervical malignancy.
* Symptoms suggestive of endometriosis .
* Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

Primary outcomes:
measure: Pain score
timeFrame: 1year
Secondary outcomes:
measure: Easiness
timeFrame: 1year
measure: Duration of the procedure
timeFrame: 1year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr alainy hospital, faculty of medicine , Cairo university
Study officials:
affiliation: Cairo University
name: Waleed El-khayat, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05625165: Epidemiology of Pediatric Traumatology
Official title: Epidemiology of Pediatric Traumatology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fractures in Children
Keywords: Fractures in Children
pediatric fractures
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma

Brief summary: Fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. Despite this, the epidemiology of pediatric fractures remains poorly detailed.

Investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.


Eligibility criteria: Inclusion criteria:

* Children treated in the pediatric emergency department of the Strasbourg University Hospitals between January 2014 and December 2020 for skeletal trauma.
* Child and Holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition

Exclusion criteria:

* Patient or legal representative who expressed their opposition to participating in the study
* Impossibility of giving informed information to the subject

Primary outcomes:
measure: Incidence of pediatric trauma and fractures and to determine the characteristics of patients, traumas and lesions
timeFrame: Files analysed retrospectively from January 01, 2014 to December 31, 2012 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Orthopédique Pédiatrique - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT03419065: Relaxation Interventions for Pre-term Mothers on Hospitalized Bed-Rest
Official title: Relaxation Interventions for Pre-term Mothers on Hospitalized Bed-Rest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Pregnancy
Lead sponsor: Towson University
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effects of participation in relaxation exercises on pregnant women who are hospitalized on bed-rest.

Detailed description: Women, 18 or older, who consent to this study will participate in a preliminary interview. Study participants will then be trained in the use of progressive muscle relaxation and guided imagery for pregnancy. Participants will be issued a listening device and an audio file and asked to practice it on a daily basis while in the hospital.

Prior to discharge or delivery, the participant will be visited by a member of the research team who will conduct a follow-up interview. The interviews and the relaxation practice sessions will take between 30 and 45 minutes each. The interviews will be audio-recorded, although no identifying information about the participants will be recorded.

At the conclusion of the study, participants will be given a CD of the audio relaxation program and thanked for their participation in the study.

There is minimal risk anticipated in association with participation in this study. All information gained from this study will remain confidential and is for educational purposes only. Participants are entitled to terminate their participation in the study at any time.

It is hoped that the results of this study will provide information about an intervention that may be beneficial to women with high-risk pregnancies. It is also hoped that participation in the exercises will be enjoyable and/or beneficial to you in some way. The results of this study may be used to justify further studies or to influence the type of interventions offered in this or similar settings.

All data collected from the research will remain confidential. Data collected from participants will immediately be assigned an identification number so that no one will be able to identify any individuals in the study.

Eligibility criteria: Inclusion Criteria:

* Pregnant women on bed rest for high risk pregnancy

Exclusion Criteria:

* none

Primary outcomes:
measure: Interview
timeFrame: 5-7 days
Secondary outcomes:
measure: Post-survey
timeFrame: 5-7 days
Other outcomes:
Locations:
city: Towson
country: United States
facility: Towson University
state: Maryland
Study officials:
affiliation: Towson University
name: Jenna Yeager, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00425165: Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
Official title: A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 6
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate CF lung disease


Eligibility criteria: Inclusion Criteria:

* have confirmed diagnosis of cystic fibrosis
* have FEV1 of greater than or equal to 60% of predicted normal for age, gender, and height
* be able to reproducibly perform spirometry maneuvers
* be clinically stable for at least 4 weeks prior to screening

Exclusion Criteria:

* have abnormal renal or liver function
* have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease
* have had a lung transplant

Primary outcomes:
measure: Change in mucociliary clearance from baseline
timeFrame: 30, 60, and 90 minutes post aerosol inhalation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00539565: RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia.
Official title: Phase IIIb Study of Corticosteroids as Post-Operative Adjuvant Therapy in Biliary Atresia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Biliary Atresia
Keywords: biliary atresia
Kasai portoenterostomy
corticosteroids
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2007-10-04
Enrollment: 100
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. The study tests the hypothesis that post-operative steroids improve outcome following the Kasai procedure - the commonest surgical treatment.

Detailed description: Biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. The disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. Within the liver there is also a pronounced inflammatory response. The initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). This is known as the Kasai procedure. This is successful in \~50% of cases in reducing the level of jaundice to near-normal values. The use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.

Eligibility criteria: Inclusion Criteria:

* biliary atresia

Exclusion Criteria:

* \<100 days at portoenterostomy
* no other anomalies (e.g. Biliary Atresia Splenic Malformation syndrome)
* anu contra-indications to corticosteroids

Primary outcomes:
measure: clearance of jaundice (<20 umol/L)
timeFrame: 1 year
measure: Proportion transplanted or died
timeFrame: 1 year
Secondary outcomes:
measure: biochemical indices of liver function
timeFrame: 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Kings College Hospital
name: Mark Davenport, ChM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05805865: Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index
Official title: Efficacy of Eco-Friendly Toothpaste Tablets Versus Conventional Toothpaste Using PI and GI Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gingival Inflammation
Keywords: Gingival Index
Plaque Index
Dentifrice
Toothpaste Tablets
Consumer Satisfaction
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objectives: To assess the change in gingival index (GI) and plaque index (PI) when comparing the use of toothpaste tablets to conventional toothpaste.

Methods: 40 participants were randomized into two groups: Colgate's toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (C). Both groups utilized their assigned dentifrice for 2 weeks. A pre and post-assessment measured the GI and PI index. A questionnaire on the use of the product was distributed.


Eligibility criteria: Inclusion Criteria:

1. Subjects are 18 years or older;
2. Subjects who will comply with study protocol;
3. Subjects who can read and understand the consent form;
4. Subjects available during the study period;
5. Subjects have more than 20 teeth.

Exclusion Criteria:

1. Subjects who are pregnant and/or nursing;
2. Subjects under the age of 18.

Primary outcomes:
measure: Plaque Index Score at Baseline
timeFrame: Change between baseline at visit 1 and visit 2, two weeks post baseline.
measure: Gingival Index Score at Baseline
timeFrame: Change between baseline at visit 1 and visit 2, two weeks post baseline.
Secondary outcomes:
measure: Subject Perception of Product Use
timeFrame: Visit 2 two weeks post study enrollment
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: So Ran Kwon, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01046565: Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Official title: Split-Face Tolerability Comparison Between Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Skin Manifestations
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 years and older
* Subjects with healthy skin as determined by the clinical grader.

Exclusion Criteria:

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions.
* Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study
* Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%)
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment.
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids.
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated.
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.).

Primary outcomes:
measure: Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Category of the Tolerability Assessments (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3.
timeFrame: baseline to week 3
Secondary outcomes:
measure: 6 Question Subject Cosmetic Acceptability Questionnaire
timeFrame: week 3
Other outcomes:
Locations:
city: Carrollton
country: United States
facility: Thomas J. Stephens & Associates, Inc.
state: Texas
Study officials:
affiliation: Galderma R&D
name: Ronald W Gottschalk, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04118465: Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
Official title: Prospective Randomized Controlled Trial Comparing ECV Success Rates With and Without Full Urinary Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breech Presentation; Before Labor
Keywords: breech; ECV; version
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.

Detailed description: A comparison of external cephalic (ECV) success rates when ECV performed with full urinary bladder or not. The study is prospective and randomised. Both nulliparous and multiparous women will be enrolled in the study, however each group will be randomized separately either to full urinary bladder or not. Written informed consent will be obtained prior to inclusion in the study.

Eligibility criteria: Inclusion Criteria:

* non-cephalic presentation,
* singleton pregnancy,
* term gestation,
* No previous attempt at ECV in this pregnancy,
* signed informed consent.

Exclusion Criteria:

• Any contraindication for vaginal delivery

Primary outcomes:
measure: ECV success rate
timeFrame: immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
References: