louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05824130: Clinical Outcomes in HIV With Comorbidities
Official title: Renal, Metabolic, Hepatic and Bone Outcomes in People Living With HIV and Other Co-morbidities Receiving Different Anti-retroviral Regimens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hiv
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-04-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People living with HIV (PLWH)

Brief summary: Multi-arm, non-randomized, quality of life

Detailed description: This is a prospective, longitudinal, observational study, performed at a Co-morbidities clinic for PLWH. PLWH with one or more co-morbidities receiving anti-retroviral therapy (ART) will be analyzed for their prevalence and incidence of developing renal, metabolic, hepatic and bone diseases. All participants will be assessed at baseline and followed up for one year, or until change in ART regimen, whichever earlier.

Eligibility criteria: Inclusion Criteria:

1. HIV antibody positive
2. Age above 18 years
3. Diagnosis of one or more co-morbidities, including hypertension, diabetes, dyslipidemia, chronic kidney disease, chronic liver disease, and cardiovascular diseases
4. Receiving ART regimen, which consists of B/F/TAF, or 1-2 NRTI(s), plus another anti-retroviral drug, including INSTI other than bictegravir, NNRTI, or protease inhibitor

Exclusion Criteria:

1. Recent diagnosis of AIDS within 6 months
2. Recent hospitalization for management of acute medical problems within 6 months
3. Receiving ART regimens other than the combinations listed in Inclusion Criteria

Primary outcomes:
measure: Renal diseases
timeFrame: Baseline
measure: Dyslipidemia
timeFrame: Baseline
measure: Cardiovascular risk
timeFrame: Baseline
measure: Liver steatosis and fibrosis
timeFrame: Baseline
measure: Low bone mineral density
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: Baseline
Secondary outcomes:
measure: Incidences of Comorbidities
timeFrame: 12 months or at the time of change of ART regimen
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Grace Lui
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05452330: The Effect of Two Different Massages on Migraine
Official title: Comparison of the Effectiveness of Connective Tissue Massage and Classical Massage in Patients With Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Manuel Therapy
Lead sponsor: Biruni University
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the effects of connective tissue massage on pain severity, attack frequency and duration, migraine-related disability, and quality of life in patients diagnosed with migraine, by comparing them with the classical massage.


Eligibility criteria: Inclusion Criteria:

* Volunteers with a migraine diagnosis
* Taking only analgesics for migraine treatment and continuing their routines
* No problem in reading, writing and understanding Turkish

Exclusion Criteria:

* Having any other neurological problems
* Who had been injected with botulinum toxin in the last 3 months

Primary outcomes:
measure: Pain Intensity
timeFrame: 8 weeks
Secondary outcomes:
measure: Migraine Related Disability
timeFrame: 8 weeks
measure: The Quality of Life
timeFrame: 8 weeks
measure: Perceived Patient-Reported Change
timeFrame: 8th week (one week)
measure: The general descriptive demographic information
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Biruni University
state: Zeytinburnu
Study officials:
affiliation: Biruni University
name: Arzu Özdinçler, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01543230: CoMplete™ Acetabular Hip System
Official title: Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Post-traumatic Arthritis
Keywords: Non-Inflammatory Degenerative Joint Disease
Lead sponsor: DePuy Orthopaedics
Sponsor class: INDUSTRY
First posted: 2012-03-02
Enrollment: 58
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.

Detailed description: This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.

Eligibility criteria: Inclusion Criteria:

* 1. If the subject:

  1. Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
  2. Qualifies based on the approved labeling for the device; and
* 2. Is willing and able to provide informed patient consent for participation in the PAS study; and
* 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and
* 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has

  * consented to participate,
  * authorized release of Personal Health Information (PHI),
  * met all eligibility criteria through the operative stage, and
  * received the implant as noted in this protocol.

Exclusion Criteria:

* Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.

Primary outcomes:
measure: Survivorship
timeFrame: 10 years
Secondary outcomes:
measure: Metal Ion Levels
timeFrame: 5 years, 8 years, and 10 years postoperatively
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Hip and Knee Arkansas Foundation
state: Arkansas
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: Ft. Collins
country: United States
state: Colorado
city: Charlotte
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Seattle
country: United States
state: Washington
Study officials:
affiliation: DePuy Orthopaedics
name: Dave Whalen, BS, DC
role: STUDY_DIRECTOR
References:
Clinical trial NCT00556530: Examining Genetic Factors That Affect the Severity of 22q11.2 Deletion Syndrome
Official title: Genetic Modifiers of 22q11.2 Deletion Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: DiGeorge Syndrome
22q11.2 Deletion Syndrome
Keywords: Congenital Heart Defects
Single Nucleotide Polymorphisms
Copy Number Variations
Whole Genome Association Study
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-11-12
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with 22q11.2 deletion syndrome

Brief summary: 22q11.2 deletion syndrome is a genetic disorder that can cause heart defects, facial abnormalities, and developmental and learning disabilities. The severity of the disorder can vary widely among people. This study will analyze DNA from people with 22q11.2 deletion syndrome to identify genetic variations that may affect the severity of the disorder.

Detailed description: 22q11.2 deletion syndrome is a disorder caused by the deletion of a small piece of chromosome 22. Most people with this disorder are missing a sequence of about 3 million DNA building blocks on chromosome 22 within each cell. This disorder affects many areas of the body. People with 22q11.2 deletion syndrome may have heart defects, immune deficiency, kidney abnormalities, hearing loss, and cleft palate or other facial deformities. Many children experience developmental delays and learning disabilities, and they have an increased risk of developing mental illnesses, including schizophrenia, depression, anxiety, and bipolar disorder. All people with 22q11.2 deletion syndrome are missing the same sequence of DNA, but the severity of this disorder varies widely; some people are diagnosed with multiple health and developmental problems, while others experience very few symptoms. In some people, the symptoms may be so minimal that they are not even aware they have 22q11.2 deletion syndrome. This study will examine genetic material-either from blood or saliva-among people with 22q11.2 deletion syndrome. Participants will attend one study visit and undergo either blood or saliva collection. By analyzing the DNA sequences of participants, the study will aim to identify any genetic variations that may affect the severity of 22q11.2 deletion syndrome.

Eligibility criteria: Inclusion Criteria:

* Has 22q11 deletion of 3 megabases (Mb)

Exclusion Criteria:

* Has 22q11 deletion smaller than 3 Mb or no deletion

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Albert Einstein College of Medicine
name: Bernice E. Morrow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04836130: Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
Official title: Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures Reduction Using Patient Specific Guide (PSG) Versus Conventional Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Zygomatic Fractures
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of The Accuracy of Zygomatico- Maxillary Complex (ZMC) Fractures reduction Using Patient Specific Guide (PSG) Versus Conventional Technique


Eligibility criteria: Inclusion Criteria:

* • Zygomatic Fracture Type III, IV and V according to rowe and killey classification(13)

  * Age (18-60 years)
  * Recent fracture (less than 2 weeks)

Exclusion Criteria:

* • Zygomatic Fracture Type I, II and VI according to rowe and killey classification(13)

  * Medical compromised patient
  * Patient on radiotherapy
  * Bone disease

Primary outcomes:
measure: accuracy of reduction of the fractured zygoma ( facial asymetry )
timeFrame: up to 6 months
Secondary outcomes:
measure: operation time
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03436030: Atrial and Ventricular Wall Stress During Breathing
Official title: Atrial and Ventricular Wall Stress, Effects of Breathing and Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
First posted: 2018-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.
Primary purpose: DIAGNOSTIC

Brief summary: Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.

Detailed description: With focus on atrial wall strain and strain-rate, In healthy volunteer adult subjects, heart ultrasound is recorded during resting, Valsalva manoeuver, Muller manoeuver, passive leg raising, and handgrip. Echocardiographic recordings are made before and during each intervention. Participants are otherwise resting in a reclined position.

Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* known heart or lung disease

Primary outcomes:
measure: Change in atrial wall stress during breathing manoeuver, compared to control measurement immediately before the breathing manoeuver
timeFrame: 30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University, and the University Hospital of Umeå
Study officials:
References:
citation: Gottfridsson P, A'Roch R, Lindqvist P, Law L, Myrberg T, Hultin M, A'Roch A, Haney M. Left atrial contraction strain and controlled preload alterations, a study in healthy individuals. Cardiovasc Ultrasound. 2022 Mar 30;20(1):8. doi: 10.1186/s12947-022-00278-1.
Clinical trial NCT05209230: Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?
Official title: Is Myocardial Stunning Induced by Continuous Renal Replacement Therapy a Reality in Critically Ill Patients?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Kidney Injury KDIGO 3
Continuous Renal Replacement Therapy Initiated by the Clinician in Charge Without Emergency
Myocardial Stunning
Keywords: Acute kidney injury,
continuous renal replacement therapy
myocardial stunning
regional wall motion abnormalities
2D speckle tracking echocardiography
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Myocardial stunning during chronic intermittent hemodialysis is a well-described phenomenon. Little case series of patients presenting myocardial stunning during renal replacement therapy for acute kidney injury in critically ill patients are reported, with intermittent hemodialysis and continuous renal replacement therapy. However, the small sample sizes and the absence of a control arm limit their interpretation, mainly whether the myocardial stunning may be related to cardiac loading conditions variations and whether it may impact the hemodynamic.

The investigator hypothesize that myocardial stunning induced by renal replacement therapy is frequent, independent from cardiac loading conditions and associated with peripheral hypoperfusion.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Acute Kidney Injury grade 3 (KDIGO)
* Indication for renal replacement therapy for the clinician in charge

Exclusion Criteria:

* Emergency indication to renal replacement therapy (pH\<7.15, Kaliemia \> 6mmol/L, refractory pulmonary oedema)
* Poor echogenicity with speckle tracking analysis failure
* Chronic hemodialysis
* Extra corporeal membrane oxygenation, left ventricular assist device.

Primary outcomes:
measure: Number of segment of the left ventricle with regional wall motion abnormalities
timeFrame: Change between the echocardiography at baseline and the echocardiography 4 hours after.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Département d'anesthésie-réanimation Hôpital cardiologique Louis Pradel Groupe Hospitalier Est
city: Bron
country: France
facility: Ruste Martin
city: Lyon
country: France
facility: Hopital Edourd Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: RUSTE Martin, MD, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01770925: n-CPAP Versus n-BiPAP and NIPPV for Postextubation in RDS in Preterms
Official title: Non-invasive Ventilation as a Post Extubation Mode for RDS: a Randomized, Cotrolled Trial to Compare n-CPAP by n- Bipap and NIPPV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Distress Syndrome
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2013-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: non-invasive ventilation in preterms complaining from RDS a randomized, controlled trial to compare between capap, n-bipap and NIPPV

Detailed description: The primary aim of this study is to compare the impact of early extubation to nasal continuous positive airway pressure (n-CPAP) versus nasal Bilevel positive airway pressure (n-BiPAP) and non invasive positive pressure ventilation(NIPPV) on the need for mechanical ventilation via endotracheal tube (MVET) to 7 days of age or less in preterm infants less than or equal to 34 weeks' gestation requiring intubation and surfactant if indicated for respiratory distress syndrome within 120 min of delivery . Second aim is to compare different outcomes of post-extubation n-CPAP , n-BiPAPand NIPPV.

Eligibility criteria: Inclusion Criteria:

* preterm infants lessthan 34wk

Exclusion Criteria:

* preterms less than 1000 g birth weight
* infants with apgar 0at 1 min
* presenceofany other cause of respiratory distress as: congenital malformation affecting the cardiorespiratory system ,neuromuscular disease ,fetal hydrops , interventricular hemorrhage and chromosomal aberrations

Primary outcomes:
measure: Failure of extubation during the first 48 hours post-extubation
timeFrame: during the first 48 hours post-extubation
Secondary outcomes:
measure: total days of non invasive ventilation
timeFrame: for 10 days from the hour of extubation
measure: length of hospital stay
timeFrame: 30 days postnatal age
measure: pneumothorax
timeFrame: 10 days post extubation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Professor of paediatrics Ain Shams University
name: Rania EL-Farrash, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04179825: Parents' and Clinicians' Perspectives of the Quick Parenting Assessment (QPA)
Official title: Integration of the Quick Parenting Assessment (QPA) Into Pediatrics: Parents and Clinicians' Perspectives
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Social Stress
Parenting
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 582
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parents of young children presenting with their child for a well visit.

Brief summary: A quality improvement (QI) study that integrates an adverse childhood experiences (ACEs) instrument, including the Quick Parenting Assessment (QPA), into pediatric primary care visit.

Detailed description: Adverse childhood experiences (ACEs) are social determinants of health. ACEs include exposure to unhealthy parenting and family dysfunction. It is known that people who are exposed to adverse childhood experiences (ACEs) are at increased risk of over 40 health problems; some of these include heart disease, lung disease, obesity, smoking, alcoholism, illicit drug use, depression, suicide, and violence. The American Academy of Pediatrics recommends that primary care providers screen for and address ACEs/social determinants of health as part of the routine primary care visit.

Efforts are needed to develop and test algorithms that assess for ACEs in pediatric primary care and intervene as indicated.

The investigators have tested an ACEs screening instrument that includes the Quick Parenting Assessment with hundreds of parents of 2-10 year old children in the pediatric primary care clinic at Vanderbilt without incident (please see IRB# 161987).

The next step is a quality improvement (QI) study that integrates an ACEs screening algorithm into pediatric primary care visit.

In this study, the investigators integrate the Quick Parenting Assessment into the pediatric primary care visit at the 15 month, 30 month, 5 year, and 8 year visit. Key measures include parents' and health care providers' perspectives on the new service.

Eligibility criteria: Inclusion Criteria:

* Parents of 1-10 year old children presenting to a pediatric clinic for a well child visit.

Exclusion Criteria: Parents who do not speak English, Spanish, or Arabic.

Primary outcomes:
measure: Parent feedback
timeFrame: One day. The outcome will be assessed on same day as enrollment.
measure: Health care provider feedback.
timeFrame: One day. This outcome will be assessed on same day as the parent's enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
References:
Clinical trial NCT06729125: Transcranial Photobiomodulation With Patients With Parkinson's Disease
Official title: Posture Stability and Functional Activity Changes After Transcranial Photobiomodulation for Patients With Parkinson's Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: transcranial photobiomodulation, posture instability, Parkinson's disease, modified Parkinson activity scale, Biodex balance system
Lead sponsor: Al-Zaytoonah University of Jordan
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 38
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease. It is a progressive and disabling disease with significative impact on quality of life. Since it has no cure, available treatment is targeted to improve the symptoms due to a lack of dopamine in the central nervous system. The aim of the study was to see how transcranial photobiomodulation (tPBM) helped patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* idiopathic PD,
* Hoehn \& Yahr stage I-IV,
* independent gait with or without technical assistance
* stable parkinsonian medication for at least a month before the study star.

Exclusion Criteria:

* comorbidities that affect balance or walking,
* other neurological pathologies besides PD,
* chronic diseases not medically controlled and participation in another physiotherapy program or sport activity during the intervention period or in the month before starting the study

Primary outcomes:
measure: posture stability
timeFrame: 8 weeks
Secondary outcomes:
measure: functional activity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Amaan
country: Jordan
facility: Al Zaytoonah University
Study officials:
References: