louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06823076: Impact of the COVID-19 Pandemic on Central Precocious Puberty: a Retrospective Cohort Study from Turkey
Official title: Impact of the COVID-19 Pandemic on Central Precocious Puberty: a Retrospective Cohort Study from Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19- Infection with SARS-CoV-2 Virus
Keywords: Central precocious puberty, COVID-19 pandemic, GnRH analogs, pediatric endocrinology, lifestyle changes
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-12
Enrollment: 192
Sex: FEMALE
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients admitted to the Pediatric Endocrinology Departments of Umraniye Training and Research Hospital and Suleyman Demirel University, located in two different cities in Turkey. These patients were diagnosed with precocious puberty and treated with GnRH analogs before and after the COVID-19 pandemic. The patients were categorized into two groups: the pre-pandemic group (admitted and started GnRH analog treatment between March 2018 and March 2020) and the pandemic group (admitted and started GnRH analog treatment between March 2020 and March 2022), covering 24 months before and after the start of the pandemic lockdown

Brief summary: Objective: This study investigates the clinical and demographic characteristics of girls diagnosed with central precocious puberty (CPP) in the pre-pandemic and pandemic periods to assess potential changes during the COVID-19 pandemic.

Detailed description: Methods: A retrospective cohort study was conducted on patients admitted to the Pediatric Endocrinology Departments of two centers in Turkey. Girls treated with GnRH analogs between March 2018 and 2022 were categorized into two groups: the pre-pandemic group (2018-2020) and the pandemic group (2020-2022). Clinical, anthropometric, and hormonal data were analyzed. Patients with organic lesions, genetic conditions, or medications affecting puberty were excluded.

Eligibility criteria: Inclusion Criteria (Who Can Participate?)

Girls: Tanner stage ≥2 before age 8 peak LH \> on gnrh analog test, basal Lh \>0,3

Patients with organic lesions (e.g., hypothalamo-pituitary tumors), congenital malformations, oncological diseases, neurosurgical or genetic disorders, or medications affecting puberty were excluded from the study

Primary outcomes:
measure: Mean Age at Pubertal Onset
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: the Pediatric Endocrinology Departments of Umraniye Training and Research Hospital
Study officials:
References:
Clinical trial NCT06045676: Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
Official title: Electrocardiographic Changes Among Epileptic and Non Epileptic Seizures in Children at Sohag University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Seizures
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 160
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children with drug resistant epilepsy , responsive epilepsy , febrile seizures and breath holding spells with age of 1 year to 12 years

Brief summary: Epilepsy is a chronic disease triggered by increased impulsiveness of nerve cells in the brain and may require a lifelong treatment. Epilepsy is confirmed by two or more unprovoked seizures in more than 24 hours. Febrile Convulsion is another type of seizure occurring due to fever over 38 °C without a history of convulsion, CNS infection, electrolyte imbalance, metabolic disorder, intoxication, and trauma. Unlike epileptic seizures, there are non-epileptic seizures such as Breath Holding Spells that affect children's behaviors and often look like epileptic seizures.

QT parameters elongation show the danger of dysrhythmia and unexpected sicknesses such as cardiomyopathy, mitral valve prolapse, ischemic coronary illness, and kidney disorders.

Many investigators have reported changes in QT parameters in various diseases such as diabetes mellitus, celiac disease, thalassemia , epilepsy ,Breath holding spells and febrile seizure.


Eligibility criteria: Inclusion Criteria:

* children with drug resistant epilepsy.
* febrile seizures.
* age of 1 year to 12 years.

Exclusion Criteria:

* age below 1 year and above 12 years
* children with convulsion secondary cns infection , encephalitis, encephalopathy , toxic and metabolic problem

Primary outcomes:
measure: QT interval
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
Clinical trial NCT06397976: The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
Official title: The Heidelberg Engineering ANTERION Software Comparison Precision and Agreement Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Eyes With Normal Anterior Segment
Eyes With Abnormal Anterior Segment
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2024-05-03
Enrollment: 37
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Eyes with normal and eyes with abnormal anterior segment population

Brief summary: This study is conducted to compare the the investigational device ANTERION with software version 1.5 against the ANTERION with software version 1.2.4 (cleared version)


Eligibility criteria: Inclusion Criteria Normal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with normal anterior segment

Exclusion Criteria Normal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging
6. Cataract grade ≥1.5

Inclusion Criteria Abnormal Anterior Segment

1. Age 22 years or older
2. Able and willing to undergo the test procedures, sign informed consent, and follow instructions
3. Able to fixate
4. Eye(s) with abnormal anterior segment (including cataract grade ≥ 1.5)

Exclusion Criteria Abnormal Anterior Segment

1. Active infection or inflammation in the study eye
2. Insufficient tear film or corneal reflex
3. Physical inability to be properly positioned at the study devices or eye exam equipment
4. Rigid contact lens wear 2 weeks prior to imaging
5. Soft lenses worn within one hour prior to imaging

Primary outcomes:
measure: Central Cornea Thickness
timeFrame: Through study completion, an average of 1 day
measure: Thinnest Point Thickness
timeFrame: Through study completion, an average of 1 day
measure: Lens Thickness
timeFrame: Through study completion, an average of 1 day
measure: Anterior Chamber Depth
timeFrame: Through study completion, an average of 1 day
measure: Axial Length
timeFrame: Through study completion, an average of 1 day
Secondary outcomes:
measure: Adverse Events Rate
timeFrame: Through study completion, an average of 1 day
Other outcomes:
Locations:
city: Willmar
country: United States
facility: Fischer Eye Laser Center
state: Minnesota
Study officials:
affiliation: Fischer Laser Eye Center
name: Jeffrey Fischer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03716076: Carbetocin on Myocardial Repolarization Dynamics in Obstetrics Study
Official title: The Effect of Carbetocin Dose on Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cardiac Arrythmias
Keywords: Carbetocin
Myocardial repolarization
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Relationship between carbetocin dose on transmural dispersion of repolarization (TDR).

Detailed description: Carbetocin is a uterotonic used to prevent postpartum hemorrhage. Although it has been proven to be completely safe, little is known about its effects on the electrical activity of the heart. The investigators aim to determine its effect on myocardial repolarization dynamics

Eligibility criteria: Inclusion Criteria:

* Pregnant patients ≥ 36 weeks gestation, for elective Cesarean delivery under neuraxial anesthesia
* American Society of Anesthesiologists (ASA) class 2
* Patients ≥ 19 years of age

Exclusion Criteria:

* Long QT syndrome
* Cardiac disease or rhythm abnormalities
* Family history of long QT syndrome or abnormal cardiac conduction
* Currently taking medication that is known to prolong the QT interval
* Women who are high risk for uterine atony as outlined in SOGC
* Known allergic reaction or hypersensitivity to Carbetocin or any other oxytocin homologue
* Patients who are unable to give informed consent because of a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.

Primary outcomes:
measure: Tp-e
timeFrame: 5 minutes post-carbetocin administration
Secondary outcomes:
measure: Arrhythmia
timeFrame: perioperatively, typically ranging 30 minutes-1 hour
measure: QTc at 5 Min
timeFrame: 5 min post-carbetocin administration
measure: QTc 10 Min
timeFrame: 10 minutes post-carbetocin administration
measure: QTc 5 Min Spinal
timeFrame: 5 min post-administration of spinal anesthesia
measure: Tp-e 5 Min Post-spinal
timeFrame: 5 minutes after administration of spinal anesthesia
measure: Tp-e at 10 Min
timeFrame: 10 minutes post-carbetocin administration
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anton Chau, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Clunies-Ross N, Roston TM, Taylor J, Whyte S, Albert A, Gorges M, Chau A. The Effect of Carbetocin Dose on Transmural Dispersion of Myocardial Repolarization in Healthy Parturients Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia: A Prospective, Randomized Clinical Trial. Anesth Analg. 2021 Feb 1;132(2):485-492. doi: 10.1213/ANE.0000000000004712.
Clinical trial NCT06327776: New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI
Official title: Nuevos Biomarcadores y Tecnologia Para Una Mejores Reglas de predicción en el Traumatismo craneoncefálico Leve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mild Traumatic Brain Injury
Lead sponsor: Hospital Universitario 12 de Octubre
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 1000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1000 participants suffering mild TBI

Brief summary: Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.


Eligibility criteria: Inclusion Criteria:

* Mild TBI (GCS 13-15 on admission)
* Blood sample obtained ≤24h after injury

Exclusion Criteria:

* GCS 3-12 on admission
* Time of injury unknown
* Time to injury exceeding 24 hours
* Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
* Penetrating head trauma
* Patient with mechanical ventilation from the trauma scene or prehospital management.
* Venipuncture not feasible
* Subject under judiciary control

Primary outcomes:
measure: Biomarkers diagnostic performance
timeFrame: 24 hours after mild TBI
Secondary outcomes:
measure: Determination of the potential of the biomarkers in predicting neurological symptoms after TBI
timeFrame: 1 week, 3 months, 6 months and 1 year
measure: Determination of the potential of the biomarkers in predicting neurological outcome assessed by the Extended Glasgow Outcome Score (GOSE) after TBI
timeFrame: 1 week, 3 months, 6 months and 1 year
measure: Determination of the potential of the biomarkers in predicting quality of life assessed by Qolibri-OS after TBI
timeFrame: 1 week, 3 months, 6 months and 1 year
measure: Determination of the potential of the biomarkers in predicting quality of life assessed by EQ-5D-5L after TBI
timeFrame: 3 months, 6 months and 1 year
measure: Determination of the potential of the biomarkers in predicting quality of sleep assessed by the Epworth and Pittsburgh Scales
timeFrame: 3 months, 6 months and 1 year
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
References:
Clinical trial NCT06591676: Translation and Cultural Adaptation of the Dysfunctional Attitude Scale (DAS) Into Urdu
Official title: Translation and Cultural Adaptation of the Dysfunctional Attitude Scale (DAS) Into Urdu
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Keywords: DAS
CBT
Lead sponsor: Pakistan Association of Cognitive Therapists
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial to evaluate the feasibility and acceptability of delivering a new intervention. Participants who meet the inclusion criteria will be randomly allocated to intervention or control groups in a 1:1 ratio
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Translate and adapt the Dysfunctional Attitude Scale (DAS) into Urdu language and establishing the psychometric properties (reliability, validity, and norms) of the translated scale

Detailed description: the present study aims to translate and culturally adapt the Dysfunctional Attitude Scale (DAS) into Urdu language. This study aims to increase the accessibility and accuracy of clinical assessments, ultimately improving the quality of mental health care delivery and advancing research in the field of clinical psychology within Urdu-speaking communities.

Eligibility criteria: Inclusion Criteria:

Individuals aged 18 to 65 years At least 5 years of education Individuals with symptoms of Depression and Anxiety

-

Exclusion Criteria:

* Substance use disorder according to DSM-5 TR criteria Significant cognitive impairment (for example, profound learning disability or dementia) Active psychosis as determined by their primary care clinician

Primary outcomes:
measure: Cultural adapatation of DAS
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Pakistan Association of Cognitive Therapists
state: Punjab
Study officials:
References:
Clinical trial NCT05164276: Head Position on Pediatric Nasotracheal Intubation
Official title: Effect of Head Position on Nasotracheal Intubation With Video-laryngoscope in Pediatric Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of study is to evaluate whether the head position facilitates pediatric nasotracheal intubation when using a video-laryngoscope.


Eligibility criteria: Inclusion Criteria:

* Age 2-8 years old
* Amerian Society of Anesthesiologists I or II
* Patients who need nasotracheal intubation for surgery

Exclusion Criteria:

* A recent airway infection within 14 days
* Anatomical deformity in head and neck
* Modified Mallampati score IV
* Bleeding tendency in preoperative laboratory examination

Primary outcomes:
measure: Intubation time
timeFrame: Within 5 minutes
Secondary outcomes:
measure: Intubation difficulty scale
timeFrame: During intubation
measure: Epistaxis score
timeFrame: When removing the video-laryngoscope
measure: Numeric rating scale of intubation difficulty
timeFrame: During intubation
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University School of Medicine
state: Gyeong-gi
Study officials:
References:
Clinical trial NCT01166776: A Research Study Looking at Specific Tissue of the Umbilical Cord
Official title: Decellularization of Umbilical Cord Wharton's Jelly for Tissue Regenerative Applications Including Avascular Necrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varices of Umbilical Cord
Keywords: Wharton's jelly
umbilical cord
decellularization
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Children's Mercy Hospital Kansas City
First posted: 2010-07-21
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women at time of delivery

Brief summary: The purpose of this study is to isolate Umbilical cord Wharton's jelly matrix to be used as a scaffold for tissue regenerative applications, including avascular necrosis.

Detailed description: Our working hypothesis is that umbilical cord blood Wharton's Jelly matrix has all the biochemical and biomechanical characteristics needed in an ideal scaffold for tissue engineering. Accordingly, we expect matrix to support the growth and differentiation of transplanted mesenchymal stem cells. The first step in this effort is to isolate Wharton's Jelly matrix by decellularization. The second step will be to test the ability of this matrix to support the growth and differentiation of transplanted mesenchymal stem cells. The third step will be to pursue preliminary animal testing to study the ability of this matrix to support bone tissue regeneration in vivo.

Eligibility criteria: Inclusion Criteria:

* Pregnant Women
* 18 years of age or older
* willing to donate umbilical cord units

Exclusion Criteria:

* less than 18 years of age
* Has Hepatitis or HIV
* Considered High Risk
* Scheduled for C-Section due to complications during current pregnancy
* Delivered prior to Full Term

Primary outcomes:
measure: Isolation and decellularization of umbilical cord Wharton's jelly matrix
timeFrame: Immediately upon delivery
Secondary outcomes:
measure: Study the ability of the isolated and decellularized matrix to support recellularization with mesenchymal stem cells and to support their growth and differentiation
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Omar Aljitawi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903576: Stem Cell Therapy for Outer Retinal Degenerations
Official title: Stem Cell Derived Retinal Pigmented Epithelium Implantation in Patients With Outer Retinal Degenerations: Phase I/II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Age Related Macular Degeneration
Stargardt's Disease
Exudative Age-related Macular Degeneration
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a Phase I/II , open label,non randomized, prospective study to determine the safety of human embryonic stem cell derived Retinal pigmented epithelium (hESC RPE) sub retinal injections versus hESC RPE seeded on a polymeric substrate implanted in the sub retinal space,

Detailed description: To determine whether the surgical implantation of a human embryonic stem cell-derived retinal pigmented epithelium (hESC-RPE) monolayer seeded onto a polymeric versus hESC-RPE injections into the sub retinal space is a safe procedure.

6 Patients will receive hESC-RPE cell injections (100000 cells) in the sub retinal space (2 Dry Age-related macular degeneration (AMD), 2 Wet AMD with disciform scar and 2 with Stargardt's disease).

Also 5 patients Dry AMD, 5 patients with Wet AMD with disciform scar and 5 patients with Stargardt's disease with receive a subretinal implantation of the hESC-RPE seeded in a monolayer in a polymeric substrate.

Patients will be enrolled sequentially, and after the procedure the patients will be followed for 1 year.

Eligibility criteria: Inclusion Criteria:

* Patients with AMD ( Dry , Wet after failure of treatment, disciform scars)
* Patients with Stargardt's Disease BCVA on the selected eye: worse than 20/200

Exclusion Criteria:

* Other ophthalmological diseases( Glaucoma, Diabetic Retinopathy, Previous retinal surgery, uveitis)
* Systemic diseases with contraindication for surgical procedures with local anaesthesia

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events of sub retinal implantation of stem cell derived retinal pigmented epithelium in the sub retinal space.
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of side effects related to the treatment itself( injection and implantation of sub retinal stem cell related RPE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo UNIFESP
name: Rubens Belfort, MD
role: STUDY_CHAIR
References: