louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06231121: Switching to Faricimab in Neovascular Age-related Macular Degeneration Resistant to Both Aflibercept and Ranibizumab
Official title: Short-term Results With Faricimab After Multiple Sequential Treatment Switches Due to Resistance With Both Aflibercept and Ranibizumab in Neovascular Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 13
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neovascular age-related macular degeneration (AMD)

Brief summary: The goal of this retrospective single-center chart review is to establish the response rate, efficacy and safety of a single dose of intravitreal faricimab injection in real-world patients with aflibercept- and ranibizumab-resistant neovascular age-related macular degeneration.


Eligibility criteria: Inclusion criteria

* Presence of neovascular age-related macular degeneration (AMD) in the study eye
* Previous treatment with minimum 6 consecutive, monthly aflibercept (Eylea®) injections in the study eye without optimal treatment response, defined as persisting intraretinal fluid or subretinal fluid or both on optical coherence tomography scans
* Subsequently, a sequential switch to ranibizumab (Lucentis®), with minimum 1 injection, also without optimal response
* Finally, a sequential treatment switch from ranibizumab to faricimab.

Exclusion criteria

* Neovascular conditions other than AMD (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye
* Significant optical media opacities that would result in poor imaging quality on OCT scans in the study eye
* Intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch

Primary outcomes:
measure: Proportion of patients responding to the treatment switch
timeFrame: 4 weeks
Secondary outcomes:
measure: Differences in patient characteristics between individuals responding and not responding to faricimab
timeFrame: 4 weeks
measure: Changes in central retinal thickness after the treatment switch
timeFrame: 4 weeks
measure: Changes in pigment epithelium detachment (PED) height after the treatment switch
timeFrame: 4 weeks
measure: Changes in best-corrected visual acuity after the treatment switch
timeFrame: 4 weeks
Other outcomes:
measure: Frequency of ocular and systemic adverse events
timeFrame: 4 weeks
Locations:
city: Glostrup
country: Denmark
facility: Miklos Schneider
Study officials:
affiliation: Rigshospitalet Glostrup
name: Miklos Schneider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04353921: PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder
Official title: A Two-Year Observational Follow-up Study of Subjects With Major Depressive Disorder Following a Randomized, Double-Blind Single-Dose of Psilocybin or Niacin-Control
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Major Depressive Disorder
Lead sponsor: Usona Institute
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 24
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Enrollment is constrained to those participants dosed with investigational drug (psilocybin or niacin) in Study PSIL201.

Brief summary: This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent will be enrolled into this study and will complete web surveys and telephone interviews conducted by one central site at the following time intervals: months 2, 3, 4, 5 and 6 (± 7 days for each assessment) and months 8, 10, 12, 14, 16, 18, 20, 22 and 24 (± 14 days for each assessment).


Eligibility criteria: Inclusion Criteria:

* Enrollment and intervention with the investigational drug in Study PSIL201

Exclusion Criteria:

* Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale
timeFrame: 6 Months post-dosing in PSIL201
Secondary outcomes:
Other outcomes:
Locations:
city: Lauderhill
country: United States
facility: Segal Trials
state: Florida
Study officials:
References:
Clinical trial NCT03052621: Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer
Official title: Revisiting Omental Transposition in Locally Advance and Locally Recurrent Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Survival Rate
Lead sponsor: Queen Sirikit Centre for Breast Cancer
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with locally advance or locally recurrent breast cancer that aggressive chemoradiation needed.

Brief summary: Locally advance breast cancer and extensive locoregional recurrence are still considered as complexity of reconstruction. Although previous studies concluded that omental transposition was considerably indicated in poor vascularity in irradiated tissue, secondary infection and large defect become the obstacles of local tissue flaps. While some centres showed the excellent healing of omental transposition. Meanwhile, many studies showed the preferable outcome in escalating radiotherapy in term of locoregional control. In the investigators' institute, omental transposition in breast cancer has been developed for twenty years. The only institute in Thailand enhanced using this procedure in order to closure of large primary breast cancer and chest wall recurrence. This procedure is undertaken by single surgeon (Dr. K.J.). The investigators' protocol of omental transposition is including preoperative chemotherapy, preoperative accelerated radiation up to 80 Gy, approval of breast cancer centre committee, and meticulous wound care including vacuum assisted wound dressing, non-adhesive dressing. As a result, survival time could be improved.


Eligibility criteria: Inclusion Criteria:

* The patients with omental transposition operation within King Chulalongkorn Memorial Hospital
* More than 18 years of age

Exclusion Criteria:

* The patients with refusal

Primary outcomes:
measure: Survival time
timeFrame: 22 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Queen Sirikit Centre for Breast Cancer
Study officials:
References:
Clinical trial NCT03924921: The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV
Official title: The Effectiveness of a Relaxation Technique on the Quality of Life and Symptoms in People Living With HIV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: relaxation
quality of life
symptoms
pain
depression
anxiety
sleep problems
fatigue
Lead sponsor: Université de Montréal
Sponsor class: OTHER
Collaborators: name: Fonds de la Recherche en Santé du Québec
First posted: 2019-04-23
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Quality of life of people living with HIV is strongly affected by the presence of one or more symptoms, such as sleep problems, fatigue, muscle pain, anxiety and depressive symptoms. Autogenic training has shown positive effects on these symptoms in different populations, but there is very little evidence on the effects of this relaxation technique in people living with HIV.

Detailed description: The aim of this project is to evaluate the effectiveness of a relaxation technique, autogenic training, on the quality of life and the physical and psychological symptoms in people living with HIV.

Eligibility criteria: Inclusion Criteria:

* Being older than 18 ;
* have a diagnosis of HIV;
* present at least one of the following symptoms during the preceding two weeks: sleep problems, fatigue, pain, anxiety or symptoms of depression;
* understand and speak French and;
* be able to follow the instructions to learn the relaxation technique.

Exclusion Criteria:

-

Primary outcomes:
measure: Patient-Reported Outcomes Quality of Life-human immunodeficiency virus (PROQOL-HIV)
timeFrame: 3 and 6 months
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 and 6 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 3 and 6 months
measure: Brief Pain Inventory
timeFrame: 3 and 6 months
measure: State -Trait Anxiety Inventory (STAI)
timeFrame: 3 and 6 months
measure: PHQ-9
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
city: Montréal
country: Canada
facility: CUSM
state: Quebec
Study officials:
affiliation: Université de Montréal
name: Pilar Ramirez-Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02294721: Pediatric Resuscitation With Feedback Devices
Official title: Quality of Pediatric Chest Compression: Comparing Four CPR Feedback Devices With Standard BLS by a Single Rescuer: A Randomised Controlled Manikin Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study was to compare four different CPR feedback devices to standard BLS in terms of the quality of single rescuer pediatric resuscitation. Therefore, the investigators hypothesis was that there would be no difference between CPR methods in terms of chest compression quality parameters.

Detailed description: Cardiac arrest is a leading cause of death worldwide. High-quality chest compressions are of paramount importance for survival and good neurological outcome. Unfortunately, even health professionals have difficulty performing effective CPR. Chest compression (CC) is often too shallow, compression ratio is inadequate, and hands-off time is too long. CPR feedback devices might be an option for rescuers to in order to increase CC efficiency.

Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* medical profession (nurses)

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Effective compressions
timeFrame: 1 day
Secondary outcomes:
measure: Chest compression depth
timeFrame: 1 day
measure: Chest compression rate
timeFrame: 1 day
measure: effective compressions ratio
timeFrame: 1day
measure: Flow time was defined as the sum of all periods during which chest compressions were performed
timeFrame: 1 day
measure: absolute hands-off time
timeFrame: 1 day
measure: VAS (visual analogue scale)
timeFrame: 1 day
measure: Prefered CPR device
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02864121: Oncogenous HPV DNA Integration (Intégration De l'ADN Des HPV Oncogènes)
Official title: Association Between High-risk HPV Genome Integration Detected by Molecular Combing and Cervical Lesions Severity and/or Evolution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abnormal Cytology
Keywords: High-risk human papillomavirus
Integration of HR-HPV DNA
biomarker of severity
biomarker of evolution
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 407
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: High-risk human papillomavirus (HR-HPV) are involved in cervical cancer development. Integration of HR-HPV DNA in cellular genomes is considered as a major event in the cervical cancer development. The aim of this study is to validate the integration of the HPV-HR as an appropriate biomarker of the severity of precancerous lesions and progression of cervical lesions towards cervical cancer. HR-HPV integration status will be analyzed by Molecular Combing technology, which allows direct and high-resolution visualization of the integration of high-risk HPV genomes.


Eligibility criteria: Inclusion Criteria:

* women aged from 25 to 65 years
* consulting in a gynecological-obstetrical service of one of the investigator center for a colposcopy reflex after an abnormal cytology dating of less than 6 months and more than 1 month
* signature of the informed consent
* affiliated to Social Security

Exclusion Criteria:

* women vaccinated against HPV
* women who received a treatment for a cervical pathology followed by a normal
* women with a known positive HIV test
* women suffering from a chronic pathology that generate immunosuppression
* Women currently treated with immunosuppressors
* Women treated with corticoids currently or dating of less than 6 months
* protected by law
* pregnant

Primary outcomes:
measure: presence of high-risk papillomavirus in the analysis of cervical smear
timeFrame: during 36 months after inclusion
measure: integration of genome of high-risk papillomavirus detected in cervical smear according molecular combing
timeFrame: during 36 months after inclusion
measure: presence and severity of cervical lesion according to results of cervical smear, colonoscopy and histological analysis
timeFrame: during 36 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT05247021: Erector Spinae Plane Block in Spine Surgeries
Official title: Bilateral Ultrasound Guided Erector Spinae Plane Block for Postoperative Pain Management in Lumbar Spine Surgery ( a Controlled Study Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lumbar Disc Disease
Keywords: erector spinae block
Lumbar disc surgery
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study was to assess the efficacy of erector spinae plane block (ESB) for postoperative pain management in lumbar spine surgery.


Eligibility criteria: Inclusion Criteria:

* Patients American Society of Anesthesiologists physical status (ASA) I and II.
* Both sexes.
* Age between 20 to 60 years old.
* Scheduled for lumbar spine surgeries.

Exclusion Criteria:

* Patients who received long acting opioids preoperatively.
* Patients with bleeding disorders and coagulopathy.
* Infection at the injection site.
* Allergy to local anesthetics.
* Patients with significant cognitive dysfunction.
* Patients with diabetic neuropathy.
* Patients with uncontrolled hypertension or diabetes.
* Patients with advanced cardiac, respiratory, hepatic or renal disease.
* Patients with viral hepatitis or HIV.

Primary outcomes:
measure: the postoperative 24 hours morphine consumption
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Mean Blood pressure in mmHg
timeFrame: 24 hours postoperative
measure: Heart rate
timeFrame: 24 hours postoperative
measure: Patient satisfaction
timeFrame: 24 hours postoperative
measure: First time of mobilization to a chair
timeFrame: 24 hours postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: faculty of medicine , ain shams university
name: ossama mansour, professor
role: STUDY_CHAIR
References:
citation: Singh S, Choudhary NK, Lalin D, Verma VK. Bilateral Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Lumbar Spine Surgery: A Randomized Control Trial. J Neurosurg Anesthesiol. 2020 Oct;32(4):330-334. doi: 10.1097/ANA.0000000000000603.
Clinical trial NCT06892821: Prospective Cohort Study of Children Diagnosed with Type 1 Diabetes in Türkiye Between 2018 to 2022
Official title: Prospective Cohort Study of Children Diagnosed with Type 1 Diabetes in Türkiye Between 2018 to 2022
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus (T1DM)
Keywords: type 1 diabetes mellitus
children
adolescent
Lead sponsor: Turkish Pediatric Diabetes Working Group
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 2730
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients diagnosed with type 1 diabetes mellitus between 01.01.2018 and 31.12.2022 at 42 pediatric diabetes centers across 7 regions of Türkiye

Brief summary: Achieving glycemic targets with improved T1DM management reduces diabetes complications and the risk of progression. Thus, it is essential to identify the challenges in T1DM management within the country and develop strategies for improvement. In Türkiye, there is limited multicenter data regarding the clinical characteristics of children and adolescents with T1DM during the diagnosis and treatment process. This multicenter prospective cohort study aimed to determine the diagnostic and follow-up characteristics of children and adolescents with T1DM, assess the status of diabetes management in the country.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus can develop in individuals between the ages of 2 months and 18 years.

Exclusion Criteria:

* other types of diabetes mellitus

Primary outcomes:
measure: HbA1c
timeFrame: Through study completion, HbA1c will be measured during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.
measure: diabetes microvascular complications
timeFrame: through study completion, diabetes microvascular complications will be assessed during the 1st, 2nd, 3rd, 4th, and 5th years of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ministry of Health Etlik City Hospital
state: Yenimahalle
Study officials:
References:
Clinical trial NCT01152021: Comparing Safety and Efficacy of Dexmedetomidine and Propofol
Official title: Comparing Safety and Efficacy of Dexmedetomidine and Propofol in Patients Requiring Sedation for MRI Scanning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Safety and Efficacy of Sedation Medications
Keywords: dexmedetomidine
propofol
sedation
MRI
scanning
pediatric
children
Magnetic Resonance Imaging
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2010-06-29
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, open label randomized study. The purpose of this study is to compare propofol with dexmedetomidine for pediatric monitored anesthesia care for MRI, specifically identifying important patient demographics and looking at important outcomes including adverse events.

Detailed description: Patients will be randomized to either arm of the study. Throughout the sedation and recovery period, all study patients will have careful, routine documentation of hemodynamics (blood pressure, heart rate, plus oximeter, respiratory rate) as well as sedation depth. Patients will remain in recovery room until they have maintained discharge criteria for 30 minutes.

Eligibility criteria: Inclusion Criteria:

* Patient is 3 - 11 years
* Patient is scheduled for MRI at Children's Hospital Boston.
* Patient meets criteria to receive either dexmedetomidine or propofol sedation
* Patient's guardian provides written consent

Exclusion Criteria:

* Patient does not meet established sedation criteria
* Patient has history of allergy, intolerance, or reaction to dexmedetomidine or propofol or hypersensitivity
* Patient has current, repaired, or risk for Moya-Moya disease
* Patient has had a stroke within the past six months
* Patient has uncontrolled hypertension
* Patient currently uses beta antagonist, alpha 2 agonist or calcium blocker
* Known soy, Lecithin, or egg allergy

Primary outcomes:
measure: Number of Adverse Events During the Sedation and Recovery Period
timeFrame: During sedation, recovery period and overnight, up to 24 hours
Secondary outcomes:
measure: Clinical Parameters (Sedation Scales, Hemodynamic Variables, Clinical Observations)
timeFrame: During sedation, recovery and overnight, up to 24 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Randy Prescilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01917864: iPad Application to Treat Prosodic Deficits in Students With Communication Disorders
Official title: Handheld Technology for Speech Development in Students With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Communication Disorders
Keywords: Autism
Autism Spectrum Disorders
Prosody
Speech treatment
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Handhold Adaptive
First posted: 2013-08-07
Enrollment: 200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the utility of a specialized iPad application designed to treat difficulties with intonation (e.g., melody in voice) in children with autism spectrum disorders (ASD) and other communication disorders.


Eligibility criteria: Inclusion Criteria:

* SLPs, in Connecticut Public Schools, who provide intervention to students with autism spectrum disorders and related disorders
* Students, ages 4-18, who attend school in Connecticut and demonstrate prosodic difficulties secondary to a diagnosis of ASD, apraxia of speech, or other communication disorder

Exclusion Criteria:

* Students with concomitant genetic disorders

Primary outcomes:
measure: Effectiveness of software
timeFrame: 12 months
Secondary outcomes:
measure: Usability of software
timeFrame: 12 months
measure: Student engagement in treatment
timeFrame: 12 months
measure: Improvement in peer acceptance
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Frederick Shic, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: