louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05166681: Evaluation of Aesthetic Surgical Wound Closure by a Single Layer in Comparison With Traditional Multi-layer Closure
Official title: Evaluation of Surgical Wound Closure With Single Subcutaneous and Subdermal Sutures as a Single Layer in Comparison With Traditional Multiple Layer Closure in Plastic Surgery Procedures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgical Wound Closure Technique
Keywords: surgical wound closure
subdermal wound suturing
traditional wound closure
Lead sponsor: Abouqir General Hospital
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2021-12-22
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the study is comparing the results of aesthetic surgery wound closure by a single layer versus the traditional multi-layer closure as regards the wound healing time, local wound complications, and the scar formed.

Detailed description: The study puts in comparison the surgical wound closure of aesthetic procedures by single layer sutures technique, involving part of the subcutaneous tissue and the subdermal layer, with the multi-layer traditional closure, which involves subcutaneous layer closure by one or two raws of sutures and skin closure with any type of suturing techniques, then to evaluate the wound healing time, local wound complications, and the scar formed.

Eligibility criteria: Inclusion Criteria:

* all cases presented for different aesthetic surgery procedures e.g different breast contouring procedures, surgical trunk contouring procedures, Brachioplasty, and thigh lifting. No gender discrimination, age between 16-60 years.

Exclusion Criteria:

* we excluded cases in age groups beyond that designed for the study, patients with co-morbid conditions that may affect the results of wound healing e.g Diabetics. Active smokers, trauma patients, or patients that will undergo primary or secondary reconstructive procedures.

Primary outcomes:
measure: single layer closure is as efficient and reliable as the multi-layer closure
timeFrame: 6 months follow up post-surgical
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Abouqir General Hospital
Study officials:
References:
Clinical trial NCT02510781: A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis by Detecting CTCs
Official title: A Study on Neoadjuvant Therapy for Her-2 Positive Breast Cancer and the Prognosis Detecting Circulating Tumor Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasms
Lead sponsor: Hospital Affiliated to Military Medical Science, Beijing
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Docetaxel plus carboplatin and trastuzumab has been a standard treatment for patients with human epidermal growth factor receptor-2（HER-2）positive. The investigators witnessed a higher pathological complete remission(pCR) rate but no obvious increase in cardiac toxicity when used the anthracycline instead of carboplatin. The investigators expect to carry out a large sample size clinical research to optimize the existing therapeutic regimen


Eligibility criteria: Inclusion Criteria:

* 18≤aged\<70
* pathologic diagnosis of invasive breast cancer，staging ii to iii，the diameters≥2cm indicated by MRI or axillary lymph node（+）
* Immunohistochemical（IHC） positive for 3+ or FISH（+）
* clear hormone receptor（HR） status
* Eastern cooperative oncology group(ECOG)=0/1
* LVEF≥55%
* pathologic grading of Miller and Payne
* screening laboratory values with the following parameters：absolute neutrophils acount：≥1500/mm3,total bilirubin:≤2.0×ULM,Aspartate transaminase (AST)/ALT≤2.5×ULM,platelet≥80000/mm3，serum creatinine≤1.5×ULM
* no pregnant or nursing
* signed Informed consent forms

Exclusion Criteria:

* prior exposure to any treatments for breast cancer
* inflammatory/Bilateral/IV stage breast cancer
* poor physical condition
* pregnant or nursing
* Cardiac risk（Congestive heart failure、arrhythmia、myocardial infarct、Refractory hypertension（systolic pressure\>180mmHg/diastolic pressure\>100mmHg））
* any other cancer within 5 years prior to screening with the exception of cervical carcinoma and non melanoma skin cancer
* Allergic to chemotherapy drugs

Primary outcomes:
measure: pathological complete response rate
timeFrame: up to one year
Secondary outcomes:
measure: clinical response rate
timeFrame: up to one year
measure: Number of Adverse Event
timeFrame: up to one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hospital affiliated to military medical science
state: Beijing
Study officials:
affiliation: Academy MMS,China
name: zefei jiang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05778110: Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion Tissue
Official title: Multiomic Analysis of Traumatic Brain Injury and Hypertension Intracranial Hemorrhage Lesion Tissue
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injury Traumatic Severe
Intracranial Hemorrhage, Hypertensive
Keywords: Traumatic brain injury
Hypertensive intracranial hemorrhage
Multiomic analysis
Biomarker
Molecular mechanism
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe traumatic brain injury or hypertensive intracranial hemorrhage.

Brief summary: The goal of this experimental observation study is to figure out differently expressed biomarkers in lesion tissues in traumatic brain injury or hypertension intracranial hemorrhage patients. The main questions it aims to answer is:

* Which RNA, protein and metabolites are differently expressed in lesion tissues?
* What molecular mechanism is participated in TBI or ICH? Participants will be treated by emergency operation, and their lesion tissues will be collected during the operation.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 and \<65
2. Within 12 hours after brain injury
3. GCS ≥3 and ≤8
4. Closed brain injury with frontotemporal contusion or basal ganglia intracranial hemorrhage
5. Need emergency intracranial hematoma evacuating operation
6. Patient's agents are informed and consent the research

Exclusion Criteria:

1. With TBI, stroke, ICH or intracranial tumor history
2. Death within 24 hours
3. Immunosuppression state
4. Severe organ dysfunction
5. Complicated infective disease
6. Pregnant

Primary outcomes:
measure: RNA biomarkers in TBI or ICH patients' lesion tissues assessed by transcriptome bioinformatic analysis
timeFrame: Immediately after collecting tissues
measure: Protein biomarkers in TBI or ICH patients' lesion tissues assessed by proteomic bioinformatic analysis
timeFrame: Immediately after collecting tissues
measure: Metabolite biomarkers in TBI or ICH patients' lesion tissues assessed by metabolomic bioinformatic analysis
timeFrame: Immediately after collecting tissues
Secondary outcomes:
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 NCT02679781: Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care
Official title: Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conscious Sedation
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.

Detailed description: * Prospective, parallel design
* Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = \>75% airway obstruction), upper respiratory tract infection or nasal discharge.
* Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam;
* Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
* Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered).
* Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.

Eligibility criteria: Inclusion Criteria:

* healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.

Exclusion Criteria:

* enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = \>75% airway obstruction), upper respiratory tract infection or nasal discharge.

Primary outcomes:
measure: Number of Participants Compliant With Oral or Nasal Midazolam Administration
timeFrame: the compliance in taking the medication will be assessed at the time of administration and recorded immediately.
Secondary outcomes:
measure: Behavior During Dental Treatment
timeFrame: the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT04427410: The Relationship Between Oxytocin Level and Postpartum Depression
Official title: The Relationship Between Oxytocin Level Measured During Pregnancy and Postpartum Depression Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxytocin Deficiency
Postpartum Depression
Prenatal Stress
Keywords: oxytocin
Postpartum Depression
oxytocin and depression
Lead sponsor: Cukurova University
Sponsor class: OTHER
Collaborators: name: Ayseren Cevik
First posted: 2020-06-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Based on the study conducted by Eapen et al. (2014), for the relationship between oxytocin and postpartum depression symptoms, based on the correlation coefficient for the periods during and after pregnancy; For r = -0.35, a minimum sample size of 61 with 5% error and 80% power has been determined. Since there may be a quit situation during the study, the sample size was determined as 67 by expanding it with a share of 10%.

Brief summary: There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms.

Detailed description: Introduction and purpose: There are studies in the literature that associate oxytocin level with postpartum depression. This study was carried out to investigate the relationship between oxytocin levels measured during pregnancy and postpartum depression symptoms.

Method: The study was conducted with 70 women who met the research criteria. Data collection was done in two interviews. The first meeting is 30-38 at the week of gestation, the second interview is 4-12 at the week of postpartum. It was done between weeks. In each interview, a data collection form was applied first and then a saliva sample was taken. Data collection form; The questions prepared by the researchers consisted of the Edinburgh Postnatal Depression Scale (EPDS) and Beck Depression Inventory (BDI). The data were analyzed using SPSS 22.0 program and the significance value was taken as p \<0.05.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older, and having a pregnancy of 30 weeks or more

Exclusion Criteria:

* previous mental illness history, miscarriage or stillbirth history, multiple pregnancy, fetal malformation, antidepressant or anxiolytic drug use, existing chronic disease,preterm labor is the development of maternal or neonatal complications at birth, hospitalization in the neonatal intensive care unit or congenital disease.

Primary outcomes:
measure: Oxytocin levels
timeFrame: 3-6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
state: Saricam
Study officials:
References:
Clinical trial NCT02517710: Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section
Official title: Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hysterotomy Closure
Lead sponsor: Evangelical Community Hospital, Lewisburg, PA
Sponsor class: OTHER
Collaborators: name: Russell J.Stankiewicz, MD
name: Ob/GYN Associates of Evangelical Hospital
name: The Commonwealth Medical College
name: Nickolas Serniak, BS, MS 4
name: Neil Cooper, MS, MS 4
name: Jennifer L. MacDonald, PA
First posted: 2015-08-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Detailed description: Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Eligibility criteria: Inclusion Criteria:

* Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.

Exclusion Criteria:

* General Anesthesia
* Non-consent to participation

Primary outcomes:
measure: Blood loss in closure with barbed synthetic suture
timeFrame: 2 days
Secondary outcomes:
measure: Post operative pain after cesarean secton
timeFrame: 3 days
Other outcomes:
measure: time to close uterine hysterotomy incision comparing standard and barbed suture
timeFrame: total time comparision of closure rates over course of study period (2 years)
Locations:
city: Lewisburg
country: United States
facility: Evangelical Community Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04445610: Measles Vaccine: Is There a Protective Role in COVID 19 Pandemic?
Official title: Measles Vaccine: Is There a Protective Role in COVID 19 Pandemic?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus (COVID-19)
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients with confirmed COVID-19 presented to Ain Shams Hospital

Brief summary: The following two mechanisms that explain the ability of measles vaccine to cause partial protection against COVID-19. The first is that measles vaccine may increase the ability of the immune system to fight off pathogens other than measles due to the generated bystander immunity that would enhance the overall immunity against the new coronavirus. The second is that SARS-CoV-2 is proven to have structure similarities with measles, which may cause cross-reactivity and immunity between measles vaccines and COVID-19, leading to partial protection against COVID-19 in vaccinated subjects

Detailed description: Objectives:

1. To identify Measles IgG titre in SARS-COV2 infected patients .
2. correlate level of Measles IgG titre with the clinical severity of COVID-19 disease.

Secondary Objective To find an association of the postulated protective role of measles vaccine and SARS-COV2 infection

Criteria:

Inclusion criteria:included patients would be divided into 3 groups according to clinical severity of COVID-19 disease (mild ,moderate \& severe)

* All patients with confirmed COVID 19 confirmed by positive PCR . .
* Any age or gender.

Exclusion criteria:

- Any patient refusing to be involved in the study.

Methods:

* Informed consent will be taken from each subject
* Full clinical examination.
* Evaluation of Measles Antibody Titer:

The measles virus IgG antibody titer will be determined quantitatively by ELISA for quantitative determination of IgG class antibodies against Measles virus in human serum or plasma (citrate, heparin).

- Anonymous data will be retrieved from the admitted patients' files, such as:

* CBC, CRP, AST, ALT, ESR, Serum ferritin \& SARS CoV 2 RNA PCR swab results.
* Chest X ray and/or CT chest.

Eligibility criteria: Inclusion Criteria:

* All patients with confirmed COVID 19.
* Any age or gender

Exclusion Criteria:

* - Any patient refusing to be involved in the study

Primary outcomes:
measure: Viral clearance
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University Research Institute- Clinical Research Center
state: Non-US
Study officials:
affiliation: Ain Shams University
name: Amira Al Balakosy, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06937710: Analysis of Biomechanical Parameters and Return to Sport After Hip Arthroscopy
Official title: Analysis of Biomechanical Parameters and Return to Sport After Hip Arthroscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Arthroscopy
Lead sponsor: Clinique du Sport, Bordeaux Mérignac
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this prospective study is to describe dynamic movement parameters in active patients who underwent surgery between 3 and 6 months after hip arthroscopy, focusing on movements such as jumping, squatting and acceleration. By examining the relationships between these different parameters and the return to sporting activities, and by integrating different angle and alignment measurements per- and post-operatively, we hope to find predictive factors for successive rehabilitation in athletes, which could lead to more personalized rehabilitation protocols.


Eligibility criteria: Inclusion Criteria:

* Hip arthroscopy for labrum lesion
* athlete prior to arthroscopy with desire to return to sport

Exclusion Criteria:

* Previous surgery or pathology of the operated lower limb
* Contralateral hip operated
* Neurological pathology affecting movement
* Medical condition contraindicating participation in sports
* Dementia or inability to complete questionnaires and assessments
* Pregnant or breast-feeding patient
* Patient under protective supervision
* Patient not covered by a social security scheme

Primary outcomes:
measure: Symmetry of hip muscular forces between the two lower limbs
timeFrame: 3 months after surgery ; 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Merignac
country: France
facility: Clinique du Sport Bordeaux Merignac
Study officials:
References:
Clinical trial NCT06879210: Application of Artificial Intelligence in Precision Medicine and Healthcare
Official title: Application of Artificial Intelligence to Construct Whole-person Precise Smart Medicine and Precise Health Care Program in Patients With Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myasthenia Gravis
Keywords: Myasthenia Gravis
AI
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This study aims to propose an intelligent health robot that utilizes remote intelligent robots to assist patients with disease-related issues, enabling them to address their problems promptly.

Detailed description: Utilizing an information architecture system, a voice-based artificial intelligence program will be developed. The symptoms of major diseases and related knowledge will be input into this system to construct a dedicated disease platform. This platform will allow patients to remotely access it, enabling them to promptly understand and address disease-related issues, thereby improving convenience for patients.

Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with myasthenia gravis by a physician.
2. Age 20 years and above.
3. Able to use a smartphone.

Exclusion Criteria:

1. Individuals not diagnosed with myasthenia gravis.
2. Individuals who do not use smartphones or tablets.
3. Individuals who withdraw from the group midway.
4. Individuals unwilling to participate in interviews.

Primary outcomes:
measure: Can the use of a mobile device [Disease Assistance Consultation] enhance the understanding of disease care and increase knowledge related to diseases in traditional Chinese medicine?
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Yi Ting Yeh
state: Tamsui District
Study officials:
References: