louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004458: Longitudinal and Biological Study of Childhood Disintegrative Disorder
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pervasive Child Development Disorders
Autism
Keywords: autism
childhood disintegrative disorder
neurologic and psychiatric disorders
rare disease
Lead sponsor: Office of Rare Diseases (ORD)
Sponsor class: NIH
Collaborators: name: Yale University
First posted: 1999-10-19
Enrollment: 220
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: OBJECTIVES:

I. Compare the developmental course (language acquisition, diagnostic stability, predictors of outcome, and restricted interests and behaviors) of childhood disintegrative disorder versus autism and non-autistic developmental delays.

II. Collect data on molecular genetics of proband and family members.

Detailed description: PROTOCOL OUTLINE:

Patients are evaluated with the following questionnaires at ages 2-3 years and again at ages 5-9: The Autism Diagnostic Interview (ADI); The Autism Diagnostic Observation Schedule (ADOS); Assessment of cognitive functioning; Expressive and receptive language; Adaptive functioning; Measures of burden and functional assessment; The Aberrant Behavior Checklist; The Connors Rating Scale - Parent and Teacher version; and Autism Behavior Checklist

An MRI and EEG are performed, and blood samples are collected from patients and family members for molecular genetic studies.

Eligibility criteria: * Psychologically diagnosed (DSM-IV) as Childhood Disintegrative Disorder
* No known genetic or medical syndrome (Down syndrome or cerebral palsy)
* Must speak English

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
city: Chicago
country: United States
facility: University of Chicago Cancer Research Center
state: Illinois
Study officials:
affiliation: Yale University
name: Fred Volkmar
role: STUDY_CHAIR
References:
citation: Volkmar FR, Klin A, Marans WD, et al.: Childhood disintegrative disorder. In: Cohen DJ, Volkmar FR.: Handbook of autism and pervasive developmental disorders. 2nd ed., New York, NY: John Wiley, 1997, pp 47-59.
Clinical trial NCT00827658: Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm
Official title: Ulnar Nerve Block for Procedural Anesthesia - Wrist Versus Palm
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hand Surgery
Keywords: anesthesia, local
ulnar nerve
hand
surgery, plastic
blinded
randomized
prospective
local anesthesia
volar wrist block
hypothenar palm block
hand surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2009-01-23
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Ulnar nerve blockade is necessary for sensory anesthesia and analgesia in the hand during minor procedures. The course of the ulnar nerve in the forearm, wrist, and hand is predictable and has low variability. However even with known anatomic location and landmarks, ulnar nerve blocks at the wrist frequently are inadequate for procedural anesthesia. The antebrachial fascia at the wrist acts as a barrier to local infiltration. Since the fascia can not be visualized or palpated, it is commonly not penetrated, resulting in an inadequate block. Furthermore at the level of the wrist the ulnar artery lies in close proximity to the nerve and there is potential for arterial puncture while attempting injection for volar wrist block. The palmar ulnar nerve block is an injection distal to the hook of the hamate in the thenar eminence which avoids the ulnar artery and antebrachial fascia. This block has been used successfully for many years in clinical practice but has not been assessed or compared in a research study. The purpose of this study is to assess the validity of using a palmar ulnar nerve block for procedures in the hand as compared to the standard volar wrist ulnar nerve block.


Eligibility criteria: Inclusion Criteria:

* any individual who can give informed consent and is scheduled for elective hand procedures by the PI necessitating an Ulnar nerve block of the hand.

Exclusion Criteria:

* patients unable to give informed consent
* patients with previous or ongoing ulnar nerve deficits or neuropathy
* patients undergoing Guyon's canal decompression
* patients who can not comprehend or cooperate with assessment testing
* patients with abnormal two point discrimination (\> 6 mm at the test location) prior to the nerve block

Primary outcomes:
measure: Primary outcome is efficacy of sensory anesthesia and analgesia
timeFrame: 15-45 minutes
Secondary outcomes:
measure: Secondary outcome is patient perceived discomfort with block
timeFrame: 15-45 Minutes
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Stuart Martin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04320758: One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)
Official title: One Year Clinical Evaluation of Translucent Zirconia Crowns in Dental Esthetic Zone With Biologically Oriented Preparation Technique (BOPT) Versus Conventional Preparation (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Single Crowns in Aesthetic Dental Zone
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 22
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the studyto evaluate the clinical behavior of translucent zirconia crown in dental esthetic zone with biologically oriented preparation technique versus conventional preparation.


Eligibility criteria: Inclusion Criteria:

* All subjects are required to be:

  1. From 21-35 years old, be able to read and sign the informed consent document.
  2. Have no active periodontal or pulpal diseases, have teeth with good restorations
  3. Psychologically and physically able to withstand conventional dental procedures
  4. Patients with teeth problems indicated for single all ceramic restoration in maxillary esthetic zone cr

     1. Badly decayed teeth
     2. Teeth restored with large filling restorations
     3. Endodontically treated teeth
     4. Malformed teeth
     5. Malposed teeth (Tilted, over-erupted, rotated, etc.)
     6. Spacing between maxillary teeth in esthetic zone
  5. Able to return for follow-up examinations and evaluation

Exclusion Criteria:

1. Patient less than 21or more than 35 years
2. Patient with active resistant periodontal diseases
3. Patients with poor oral hygiene and uncooperative patients
4. Pregnant women
5. Patients in the growth stage with partially erupted teeth
6. Psychiatric problems or unrealistic expectations
7. Patient with periodontal problems
8. patients with malocclusion or parafunctional habits

Primary outcomes:
measure: Marginal adaptation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Cairo university
state: New Cairo
Study officials:
References:
Clinical trial NCT05889858: Medical Follow-up of Medical Secretaries of General Practitioners
Official title: Medical Follow-up of Medical Secretaries of General Practitioners
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medical Follow-up of Medical Secretaries
Keywords: medical secretaries
general practitioners
medical follow-up
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: medical secretaries of general practitioners

Brief summary: General practitioners are very often confronted with requests for care from their relatives (family, friends, etc.). In the United States, the recommendations advise general practitioners against taking care of their loved ones on several grounds: lack of professional objectivity, lack of information due to modesty, risk of loss of patient autonomy. Some countries even prohibit general practitioners from prescribing to a loved one except in an emergency.

In France, there is no current recommendation on the care of relatives. Half of French general practitioners have a physical secretary and are therefore potentially confronted with requests for care from their medical secretary.

Detailed description: The aim of the study is to describe the medical follow-up of medical secretaries of general practitioners

Eligibility criteria: Inclusion Criteria:

* medical secretaries of general practitioners
* work in face-to-face in the medical practice
* agreed to participate in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: type of attending physician
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
affiliation: Université Reims Champagne-Ardenne
name: Hurtaud Aline, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01790958: Microcurrent Stimulation to Treat Macular Degeneration
Official title: An Observational, Multi-Center Phase 1 Study of the Safety and Effectiveness of Frequency Specific Microcurrent Stimulation as an Alternative Treatment for Retinal Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Diseases
Stargardt's Disease
Retinitis Pigmentosa
Lead sponsor: Retina Institute of Hawaii
Sponsor class: OTHER
First posted: 2013-02-13
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with retinal disease such as Age-Related Macular Degeneration, STargardt's Disease, and Retinitis Pigmentosa

Brief summary: Microcurrent stimulation thereapy improves retinal efficiency and may restore and/or improve retinal function.

Detailed description: This is an observational study in which data will be collected from a group of patients with retinal diseases such as Dry Macular Degeneration, RetinitisPigmentosa, and Stargardt's Disease, who have opted to receive Microcurrent Stimulation Therapy as an alternative treatment for their retinal condition.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written consent and comply with follow up visits
* Age 40 years or older
* ETDRS best corrected visual acuity better than 5 letters
* History of Dry Age Relted Macular Degeneration; Retinitis Pigmentosa; Stargardt's disease
* No Anti-VEGF treatments for at least 3 months prior to study
* No new antioxidant/vitamin supplementation for at least 3 months prior to study

Exclusion Criteria:

* History of Non-Compliance with regular medical visits
* Significant media opacities (exclude NS 4+) that may interfere with assessing visual acuity
* Presence of pigment epithelial tears or rips
* Known serious allergies to fluorescein dye
* Presence of retinal neovascularization
* Any treatment with an investigation agent in the past 30 days

Primary outcomes:
measure: Measure visual acuity after receiving microcurrent stimulation treatments.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hilo
country: United States
facility: Hawaii Cataract Laser Institute - Hilo
state: Hawaii
city: Honolulu
country: United States
facility: Retina Institute of Hawaii
state: Hawaii
city: Kahului
country: United States
facility: Hawaii Cataract Laser Institute - Maui
state: Hawaii
city: Kailua-Kona
country: United States
facility: Hawaii Cataract Laser Institute - Kona
state: Hawaii
Study officials:
affiliation: Retina Institute of Hawaii
name: George Papastergiou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06402058: A Study Comparing DMSB01 and Rejuran® for Temporary Crow's Feet Lines Improvement
Official title: A Randomized, Subject and Evaluator Blinded, Matched Pairs, Pilot Study to Evaluate the Safety and Efficacy of DMSB01 According to the Number of Injections in Subjects With Crow's Feet Lines Compared to Control Device
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crow's Feet Lines
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2024-05-07
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Subject and Evaluator blinded, Matched pairs, Pilot Study
Primary purpose: TREATMENT

Brief summary: The objective of this Pilot Study is to verify the safety and efficacy of DMSB01 in the temporary improvement of Crow's Feet Lines


Eligibility criteria: Inclusion Criteria:

1. Among those who desire improvement in both sides of the crow's feet and have a Crow's Feet Grading Scale (CFGS) score of 2 or higher for both relaxed and maximum smile conditions
2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study

Exclusion Criteria:

1. Individuals with abnormal findings in visual-related tests (visual acuity test, Confrontational visual fields test, ocular motility test), specifically those with low vision (best-corrected visual acuity of 0.3 or less in the better eye).
2. Individuals who need to take anticoagulants from 2 weeks before the application of the investigational medical device to 2 weeks after the final application (with the exception of low dosage aspirin 100mg (up to a maximum of 300mg/day))
3. Individuals who need to take Vitamin E preparations, NSAIDs, or collagen preparations from 1 week before the application of the investigational medical device to 1 week after the final application.
4. History of bleeding disorder in past or present

Primary outcomes:
measure: Changes in CFGS at 4, 8, 12 weeks after the last application of the clinical trial medical device compared to the baseline evaluated by Investigator and independent evaluators
timeFrame: 4, 8, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jongho Kim, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02576158: HPV Integration Testing for Cervical Cancer Screening
Official title: HPV（Human Papillomavirus） Integration Testing for Cervical Cancer Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2015-10-15
Enrollment: 12000
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy women between the ages of 30 and 65 years

Brief summary: The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.


Eligibility criteria: Inclusion Criteria:

Women aged 30-65 years old Attending the China population-based organised cervical screening program

Exclusion Criteria:

1. Not providing informed consent
2. previously confirmed CIN, cervical cancer, or other malignancies
3. previous therapeutic procedure to cervix
4. pregnancy

Primary outcomes:
measure: the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT
timeFrame: 14 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
affiliation: Huazhong University of Science and Technology
name: Ding Ma, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00821158: The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
Official title: The DIEP Flap as a Model of Ischemia-Reperfusion: an Intervention Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Ischemia-Reperfusion
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-01-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will examine whether administration of certain medications will decrease or prevent ischemia-reperfusion injury.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing breast reconstruction

Exclusion Criteria:

* Diabetes mellitus
* Kidney or liver disease
* Use of immunosuppressants

Primary outcomes:
measure: Antioxidant concentrations
timeFrame: 0,5-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
affiliation: Maastricht Universtity Medical Center
name: R. van der Hulst, M.D., Phd
role: STUDY_CHAIR
affiliation: Maastricht University Medical Center
name: Marieke van den Heuvel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04465058: Characteristics of Critically Ill COVID 19 Patients
Official title: Clinical Characteristics and Outcome in Critically Ill COVID 19 Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: crirical patients need oxygen therapy

Brief summary: COVID19 is n outbreak with unpredictable outcome


Eligibility criteria: Inclusion Criteria:

* COVID 19 patients need oxygen therapy

Exclusion Criteria:

* patients does not need oxygen therapy

Primary outcomes:
measure: clinical characteristics
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT04609358: Efficacy and Safety of the Algorithm for Enteral Nutrition Support
Official title: Efficacy and Safety of the Implementation of an Algorithm for Enteral Nutrition Support Compared With Traditional Practice in Children With Congenital Heart Disease: Randomized Clinical Trial, Simple Blind.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition Disorder, Child
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 256
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The purpose of this trial is to evaluate the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease

Detailed description: In many developing countries, pediatric cardiac programs are not fully established, and nutrition support algorithm is lack. Therefore, this study aimed to evaluate the the efficacy and safety of the implementation of an algorithm for enteral nutrition support compared with usual standard practice in children with malnutrition status with congenital heart disease. The usual standard practice for feeding often interrupted by retention in the gut and then choose the parenteral nutrition support especially in the patients with unstable hemodynamic status. Actually tiny and continuous feeding would improve the gut function and reach the adequate energy supply.

Eligibility criteria: Inclusion Criteria:

weight-for-age of z-score \<-2; or length-for-age of z score \<-2; or weight-for-length of z score \<-2

Exclusion Criteria:

Any patient with congenital genetic metabolic diseases

Primary outcomes:
measure: Malnutrition recovery
timeFrame: 1 year
Secondary outcomes:
measure: Feeding intolerance
timeFrame: 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Zhuoming Xu, PhD
role: STUDY_DIRECTOR
References:
citation: Chen X, Zhang M, Song Y, Luo Y, Wang L, Xu Z, Bao N. Early high-energy feeding in infants following cardiac surgery: a randomized controlled trial. Transl Pediatr. 2021 Oct;10(10):2439-2448. doi: 10.21037/tp-21-360.