louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05401617: Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial
Official title: Impact of an Information Assistance Application in Addition to a Traditional Anesthesia Consultation on Preoperative Anxiety in Pediatrics: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Surgery
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 352
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The objective of the study is to evaluate the benefits on pre-operative anxiety of an information assistance application in addition to a traditional anesthesia consultation on preoperative anxiety in pediatrics


Eligibility criteria: Inclusion Criteria:

* Child between 4 years old (inclusive) and 10 years old (inclusive);
* Must benefit from programmed general anesthesia for scheduled surgery at the Rouen University Hospital, in the paediatrics ward;
* Benefiting from a social security scheme;
* Whose parental authority has consented to participation in the research;
* Not having expressed their refusal to participate in the research;
* Understanding French;
* Ability to access the application being researched.

Exclusion Criteria:

* Patient with cognitive disorders: disorders known in the history and assessed or suspected during the anesthesia consultation.
* Poor understanding of oral French by the child;
* Poor understanding of the oral and/or written French language by the parent/legal representative;
* Patient presenting a contraindication to general anesthesia or to the intervention during the pre-anaesthetic visit;
* Patient with severe psychiatric disorders

Primary outcomes:
measure: Level of anxiety on entering the operating room
timeFrame: 15 days
Secondary outcomes:
measure: Anxiety of parents
timeFrame: 15 days
measure: Need of an analgesic supplement in SSPI (post-interventional monitoring room)
timeFrame: 15 days
measure: Duration of stay in SSPI
timeFrame: 15 days
measure: Parents' satisfaction with the quality of the information provided
timeFrame: 15 days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Rouen
name: Vincent Compere
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02643017: Effect of Dexmedetomidine on Postoperative Cognitive Function in Patients Undergoing Shoulder Arthroscopy With Beach Chair Position Under Desflurane Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Tear
Keywords: cognitive function
desflurane
dexmedetomidine
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-12-30
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Investigate the effects of dexmedetomidine on postoperative cognitive function in patients undergoing shoulder arthroscopy with beach chair position under desflurane anesthesia.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing shoulder arthroscopic surgery with beach chair position

Exclusion Criteria:

1. Patients with respiratory disease
2. Patients with cardiac disease
3. Patients with cerebrovascular disease
4. patients with uncontrolled hypertension
5. Patients with dementia
6. Patients with psychiatric disease

Primary outcomes:
measure: Number of patients with postoperative cognitive decline assessed by mini-mental state examination
timeFrame: from 1 day before surgery to postoperative 1 day
measure: Number of patients with postoperative cognitive decline assessed by a battery of psychometric test
timeFrame: from 1 day before surgery to postoperative 1 day
Secondary outcomes:
measure: Number of patients with increase of S100ß protein after surgery assessed by ELISA assay with blood of patients
timeFrame: from 5 min after induction of anesthesia to an 1 hour after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01811017: Clinical Evaluation of 755nm Alexandrite Laser Versus Nanosecond 755nm Alexandrite
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tattoos
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare the efficacy of the 755nm Alexandrite laser to the nanosecond 755nm Alexandrite laser for the removal of unwanted tattoos using photographic evaluation and histological findings.


Eligibility criteria: Inclusion Criteria:

1. Is a healthy male or female between 18 and 85 years old?
2. Has unwanted non-cosmetic tattoo(s) and wishes to undergo laser treatments
3. Is willing to consent to participate in the study.
4. Is willing to shield the tattoo completely from sun exposure
5. Signs informed consent form
6. Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits.

Exclusion Criteria:

1. Subjects who are unwilling to consent to tattoos
2. Subjects mentally ill or incompetent
3. Subjects is unwilling to have photographs taken and used in publications or scientific presentations
4. Subjects who are prisoners
5. Subjects with recent sun exposure and suntan in the area to be treated
6. Allergic tattoos (hypersensitivity to tattoo ink)
7. History of vitiligo or keloidal scarring
8. Tattoos located on the neck or face including cosmetic tattoos
9. Subjects unwilling to tolerate partial removal of the tattoo in this study
10. Infection or skin disease in the area to be treated
11. Subjects who are immunosuppressed (e.g. HIV)
12. Subject is pregnant or nursing
13. Use of oral isotretinoin within past 12 months
14. History of squamous cell carcinoma or melanoma
15. Is allergic to Lidocaine, tetracaine or Xylocaine with epinephrine.
16. Has any other reason determined by the physician to be ineligible to participate in the study

Primary outcomes:
measure: Photographic Evaluation of Tattoo Clearance
timeFrame: up to 3 months post last treatment
Secondary outcomes:
measure: Subject biopsy sampling
timeFrame: up to 3 months post last treatment
Other outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability
timeFrame: up to 3 months post last treatment
Locations:
city: Boston
country: United States
facility: Boston Va Medical Center
state: Massachusetts
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References:
Clinical trial NCT00612417: Effect of Recombinant FVIII in Healthy Male Subjects Treated With TB-402
Official title: A Randomised, Double-blind and Placebo-controlled Study Investigating the Pharmacodynamic Effects of Administration of Recombinant Human Factor VIII in Healthy Male Subjects Treated With the Monoclonal Anti-factor VIII Antibody, TB-402
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Interaction with recombinant FVIII
Lead sponsor: ThromboGenics
Sponsor class: INDUSTRY
Collaborators: name: BioInvent International AB
First posted: 2008-02-11
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Single administration of recombinant FVIII/placebo in healthy male subjects who have been treated with a single dose of anti-factor VIII antibody, TB-402


Eligibility criteria: Inclusion Criteria include:

* Males 18 to 45 years of age
* Healthy according to medical history, physical exam, ECG, blood pressure and heart rate, and laboratory profile of blood and urine

Exclusion Criteria include:

* Self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke
* History of important bleeding episodes
* Previous allergic reaction to immunoglobulin
* Present or previous history of severe allergy, for example asthma or anaphylactic reactions
* FVIII:C \<50% or \>150% at screening
* Clinically significant out of range values for any coagulation test during screening
* Received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of TB-402

Primary outcomes:
measure: Changes in coagulation parameters after rFVIII administration
timeFrame: To study end
Secondary outcomes:
measure: PD of TB-402, safety of TB-402 alone and with rFVIII, PK of FVIII in rFVIII-treated subjects, changes in coagulation parameters after TB-402 administration
timeFrame: To study end
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Cyncron CRU
Study officials:
affiliation: Cyncron CRU
name: Thomas J Jensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01214317: Study of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Aggressive Multiple Sclerosis
Official title: Study of Combinative Effect of Induction Therapy With Mitoxantrone and Plasmapheresis to Treat Patients With Aggressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
mitoxantrone
plasmapheresis
induction therapy
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of combinative induction therapy with mitoxantrone and plasmapheresis versus induction therapy with mitoxantrone alone in cases of aggressive multiple sclerosis


Eligibility criteria: Inclusion Criteria:

* Aggressive multiple sclerosis in attack phase
* EDSS: 1-5
* No contraindication for mitoxantrone prescription
* No past history of mitoxantrone injection
* No history of corticosteroid and immunosuppressive therapy in last 3 months

Exclusion Criteria:

* Patient's incompliance
* Severe drug induced side effects

Primary outcomes:
measure: Expanded Disability Status Score
timeFrame: At the end of month 8 after treatment initiation
measure: Change From Baseline in Mean Number of MS Plaques Found on Brain MRI
timeFrame: Month 8 after treatment initiation
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alahra hospital
Study officials:
affiliation: Alzahra Hospital
name: Masoud Etemadifar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06258317: Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty
Official title: Mesh Fixation Versus Non Fixation in Laparoscopic Inguinal Hernioplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Laparoscopic
Inguinal Hernia
Hernioplasty
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Inguinal hernia is one of the most common types of abdominal hernias. Laparoscopic hernioplasty of inguinal hernia is a good alternative to traditional open repairs even in simple unilateral primary inguinal hernia in terms of decrease post operative pain and complications with comparable recurrence rates.Two techniques are described in laparoscopic hernioplasty and have been extensively studied in randomised trials. The totally extraperitoneal (TEP) approach is more widely used than the transabdominal preperitoneal (TAPP) approach.

In this study we will compare between the results of mesh fixation and non fixation as regard operative and postoperative data.


Eligibility criteria: Inclusion Criteria:

* Any male or female above 18 years old that has uncomplicated inguinal hernia

Exclusion Criteria:

* Patients with contraindications to use laparoscopy as cardiac or immunocompromised patients.
* Patients who are difficult to follow up.

Primary outcomes:
measure: Comparing fixation of conventional polypropylene mesh versus non fixation of 3D max mesh (anatomically oriented mesh) in laparoscopic trans-abdominal properitoneal (TAPP) inguinal hernia repair
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Mohamed A Rizk
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lockhart K, Dunn D, Teo S, Ng JY, Dhillon M, Teo E, van Driel ML. Mesh versus non-mesh for inguinal and femoral hernia repair. Cochrane Database Syst Rev. 2018 Sep 13;9(9):CD011517. doi: 10.1002/14651858.CD011517.pub2.
citation: Sun P, Cheng X, Deng S, Hu Q, Sun Y, Zheng Q. Mesh fixation with glue versus suture for chronic pain and recurrence in Lichtenstein inguinal hernioplasty. Cochrane Database Syst Rev. 2017 Feb 7;2(2):CD010814. doi: 10.1002/14651858.CD010814.pub2.
Clinical trial NCT06558617: Evaluating SARC-F, SARC-CalF, and Calf Circumference as Diagnostic Tools for Sarcopenia in Thai Older Adults: Results From a Nationwide Study
Official title: Evaluating SARC-F, SARC-CalF, and Calf Circumference as Diagnostic Tools for Sarcopenia in Thai Older Adults: Results From a Nationwide Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Diagnosis
Keywords: sarcopenia
calf circumference
SARC-F questionnaire
diagnostic accuracy
elderly
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2024-08-16
Enrollment: 2543
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community-dwelling older Thai adults living at that area for at least 1 year

Brief summary: As the elderly population grows, musculoskeletal disorders, including sarcopenia, have become a critical area of study due to their association with falls and fractures. Sarcopenia, characterized by decreased muscle mass, is prevalent among older adults and poses a significant risk for falls. This study aimed to assess the effectiveness of the SARC-F and SARC-CalF questionnaires, along with calf circumference measurements, in screening for sarcopenia among Thai community-dwelling older adults, following the Asian Working Group on Sarcopenia (AWGS) 2019 criteria.

Detailed description: The data utilized in this analysis were derived from the Thai Musculoskeletal Diseases Nationwide Study. This cross-sectional study targeted Thai adults aged 60 years and older, conducted between March 2021 and August 2022. Participants were sampled using a multi-level sampling technique to ensure representativeness from community-dwelling older adults across 12 provinces, encompassing Thailand's six primary geographical regions.

Participants were evaluated for possible sarcopenia or sarcopenia, according to AWGS 2019 criteria, by using SARC-F questionnaire, calf circumference measurement, SARC-CalF questionnaire, and appendicular skeletal muscle mass (ASM).

Eligibility criteria: Inclusion Criteria:

* Thai adults aged 60 years and older

Exclusion Criteria:

* missing data on SARC-F, SARC-CalF, and calf circumference
* unable to walk independently
* bedridden individuals
* neuromuscular disorders or severe comorbidities that could impair their ability to perform performance-based tests

Primary outcomes:
measure: Appendicular skeletal muscle mass (ASM)
timeFrame: up to 4 weeks
measure: Handgrip strength
timeFrame: up to 4 weeks
measure: 5-time sit-to-stand test (5TSTS)
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Apichat Asavamongkolkul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06968117: Exploration of Pregnant Women's Reluctance Toward COVID-19 Vaccination
Official title: Exploration of Pregnant Women's Reluctance Toward COVID-19 Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccinate Against Covid-19
Reluctance Pregnant Women&#39;s
Lead sponsor: Centre Hospitalier de Gonesse
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study participants will be selected from pregnant women attending pregnancy follow-up consultations, those who have visited the Gynecology-Obstetrics emergency department for any reason, and those hospitalized in the diabetes or high-risk pregnancy (GHR) departments or in postpartum care services. Participants must be over 18 years old and able to provide informed consent.

Brief summary: This study aims to explore the reasons behind the reluctance of pregnant women to get vaccinated against COVID-19. With the ongoing pandemic, it has become essential to understand the concerns that women have regarding the COVID-19 vaccine, especially during pregnancy. Pregnant women are at a higher risk of severe complications from COVID-19, including premature birth, preeclampsia, and the need for intensive care.The goal of this research is to identify the barriers that prevent pregnant women from getting vaccinated, whether they are based on fears, misconceptions, or a lack of information. By understanding these concerns, healthcare providers can have better conversations with their patients and provide accurate, evidence-based information to help them make informed decisions about their health and the health of their unborn child.Through interviews and visual methods, the study seeks to gather valuable insights into the emotional and psychological aspects of vaccine hesitancy among pregnant women. These findings will help develop a tool to assist healthcare providers in addressing vaccine hesitancy effectively, ensuring that women are given all the necessary information to make the best decision for their health and the well-being of their baby.


Eligibility criteria: Inclusion Criteria:

* During pregnancy follow-up consultations,
* Following their visit to the Gynecology-Obstetrics emergency department, regardless of the reason,
* Hospitalized in the diabetology department or in the high-risk pregnancy (HRP) or postpartum care department.

Exclusion Criteria:

* The patient is over 18 years old

Primary outcomes:
measure: The rate of vaccine hesitancy among pregnant women, assessed through a standardized questionnaire.
timeFrame: January 2021-April 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Gonesse
country: France
facility: France
Study officials:
References:
Clinical trial NCT06309017: Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease
Official title: Pre-operative Nutrition for Elective Resection Surgery in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine if improved risk stratification tools and interventions to mitigate malnutrition reduce postoperative risk in patients undergoing elective or emergent resection surgery for inflammatory bowel disease (IBD), and if adding immune modulation nutrition improves surgical outcomes. The primary objective is to assess whether preoperative malnutrition screening and intervention minimize postoperative complications. The secondary objective is to evaluate whether immune modulation nutrition in the peri-operative period decreases length of stay and major complications.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide written informed consent
2. Aged 18 years of age or older
3. Confirmed diagnosis of inflammatory bowel disease
4. Scheduled for disease-related intestinal resection at NYU Langone Health

Exclusion Criteria:

1. No current diagnosis of inflammatory bowel disease
2. Age less than 18
3. Not proficient (able to read and answer questions) in English

Primary outcomes:
measure: Length of hospital stay
timeFrame: Up to 30 days post-surgery
measure: Proportion of patients who experienced postoperative major complications
timeFrame: Visit 3 (30 days post-surgery)
Secondary outcomes:
measure: Proportion of patients who participated in a nutritional intervention program before surgery
timeFrame: Visit 3 (30 days post-surgery)
measure: Proportion of patients who participated in a nutritional intervention program after surgery
timeFrame: Visit 3 (30 days post-surgery)
measure: Number of nutritional shakes completed
timeFrame: Visit 3 (30 days post-surgery)
measure: Percentage of nutritional shakes completed overall
timeFrame: Visit 3 (30 days post-surgery)
measure: Percentage of nutritional shakes completed pre-surgery
timeFrame: One day prior to surgery
measure: Percentage of nutritional shakes completed post-surgery
timeFrame: One week post surgery
measure: Proportion of patients who experienced any postoperative complications
timeFrame: Visit 3 (30 days post-surgery)
measure: Proportion of patients with 30 day readmission
timeFrame: Up to 30 days post-surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jennifer Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: