louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03477708: The Impact of Continuous Transcutaneous CO2 (TCCO2) Monitoring in Extremely Low Birth Weight (ELBW) Infants
Official title: The Impact of Continuous Transcutaneous CO2 Monitoring (TCCO2) in Extremely Low Birth Weight (ELBW) Infants: A Prospective Observational, Multi-Center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ELBW - Extremely Low Birth Weight Infant
IVH- Intraventricular Hemorrhage
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 166
Sex: ALL
Minimum age (years): 0
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ELBW infants

Brief summary: An observational study comparing outcomes of Extremely Low Birth Weight (ELBW) infants that were monitored with non-invasive Transcutaneous CO2 (TCCO2) monitor to infants that were not monitored by TCCO2 monitor.


Eligibility criteria: Inclusion Criteria:

* ELBW infants Need of respiratory support

Exclusion Criteria:

* Parental refusal IVH before study entry chromosomal abnormalities congenital central nervous system (CNS) abnormalities

Primary outcomes:
measure: IVH-Intraventricular Hemorrhage
timeFrame: Repeated scans until infant reaches corrected age of 42 weeks
measure: PVL- Periventricular Leukomalacia
timeFrame: Repeated scans until infant reaches corrected age of 42 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
References:
Clinical trial NCT03622008: To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)
Official title: A Phase 1, Randomized, Double-Blind Study to Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ) After Intravenous Administrations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
Collaborators: name: Clinartis, LLC
First posted: 2018-08-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will receive one of the following IV treatments as a q8h infusion (90 min) regimen for 10 days:

* FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) (n=16)
* Placebo (n=4)
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult volunteers for 10 days.


Eligibility criteria: Inclusion Criteria:

* Have a body Mass Index (BMI) between 18 to 32 kg/m2 (both inclusive).
* Medical history without any major pathology.
* A sustained supine systolic blood pressure \<150 mm Hg or \>90 mm Hg or a supine diastolic blood pressure \<95 mm Hg or \>50 mm Hg at Screening or Check-in (Day -1). Blood pressure may be retested once in the supine position.
* Glomerular filtration rate (GFR) \> 80 mL/min, estimated by the Cockcroft-Gault equation.

Exclusion Criteria:

* Use of cefepime and/or tazobactam within 60 days prior to study drug administration.
* History or evidence of clinically relevant pathology which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.

Primary outcomes:
measure: Safety assessed by number of abnormal clinical laboratory test result
timeFrame: every 8 hours
measure: To measure the Maximum Concentration
timeFrame: 24 hrs
measure: To measure the Area Under the Curve [AUC]
timeFrame: 24 hrs
measure: Safety assessed by number of abnormal physical examinations findings.
timeFrame: every 8 hours
measure: Safety assessed by number of abnormal vital signs findings
timeFrame: every 8 hours
measure: Safety assessed by number of abnormal 12 Lead ECG findings
timeFrame: every 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research
state: Wisconsin
Study officials:
References:
Clinical trial NCT04203108: ATG in HLA-matched Sibling HSCT as GVHD Prophylaxis
Official title: ATG Used in Allogeneic Hematopoietic Stem Cell Transplantation From HLA-matched Sibling Donor as GVHD Prophylaxis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hematopoietic Stem Cell Transplantation
Keywords: Hematopoietic Stem Cell Transplantation
antithymocyte globulin
graft-versus-host disease
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2019-12-18
Enrollment: 266
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: The protocols including ciclosporin A （CsA）+methotrexate (MTX) +mycophenolate Mofetil(MMF) have been widely used for graft-versus-host disease (GVHD) prophylaxis in allogeneic hematopoietic stem cell transplantation from HLA-matched sibling donor (MSD). Nevertheless, severe chronic graft-versus-host disease (cGVHD) remains an obstacle for MSD HSCT. A growing body of studies have suggested antithymocyte globulin (ATG) could reduce the incidence of cGVHD. This study is aim to evaluate the efficacy of a protocol that includes CsA, MTX, MMF and ATG in recipients of MSD HSCT.


Eligibility criteria: Inclusion Criteria:

1. A patient age of 18-65 years
2. MSD transplant recipient
3. Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study

Exclusion Criteria:

1. Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
2. Patients with any conditions not suitable for the trial (investigators' decision)

Primary outcomes:
measure: the incidence of cGVHD
timeFrame: 2 year posttransplantation
Secondary outcomes:
measure: overall survival
timeFrame: 2 year posttransplantation
measure: disease-free survival
timeFrame: 2 year posttransplantation
measure: the incidence of aGVHD
timeFrame: 100 days 1 year posttransplantation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Qifa Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02478008: A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
Official title: A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mitral Insufficiency
Heart Valve Disease
Cardiovascular Disease
Heart Disease
Keywords: Transcatheter Mitral Valve Replacement
Mitral Regurgitation
Mitral Insufficiency
Transapical
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 2
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.


Eligibility criteria: Key Inclusion Criteria:

* NYHA Classification ≥ III
* Left Ventricular Ejection Fraction ≥ 30%
* Mitral regurgitation ≥ Grade 3+
* Subject meets anatomical eligibility criteria for the investigational device

Primary outcomes:
measure: Composite Major Adverse Event Rate
timeFrame: 30-Day
measure: Composite Major Adverse Event Rate
timeFrame: 12-Month
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet University Hospital
city: Lille
country: France
facility: Centre hospitalier régional universitaire de Lille
city: Paris
country: France
facility: Hôpital Européen Georges-Pompidou
city: Toulouse
country: France
facility: Centre Hospitalier Universiatier de Toulouse
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital Heart Center
Study officials:
affiliation: Rigshospitalet University Hospital (Copenhagen, Denmark)
name: Lars Søndergaard, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05763108: Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes
Official title: Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes - rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene in Patellar Instability in Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ligament; Laxity
Recurrent Patellar Dislocation
Lead sponsor: Polish Mother Memorial Hospital Research Institute
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 250
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between 7 and 17 years old with recurrent dislocation of the patella without genetic diseases.

Brief summary: The purpose of this study is to assess correlation between recurrent patella dislocation and genetic polymorphism rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene.

Detailed description: After being informed about the study and potential risk all of participants were performed phisical examination and genetic test. In the study we established two groups: In first group- 50 patients with recurrent patellar dislocation and without any genetic disorders. In the second one 200 patients without recurrent patellar dislocation and genetic disorders. All pediatric patients were between 7 and 17 years old in two groups respectivly.

Eligibility criteria: Inclusion Criteria:

• First-time diagnosed or recurrent patellar dislocation patient from 7 to 17 age years old.

Exclusion Criteria:

* Patient's age under 7.
* Presence of genetic diseases such as: Down's syndrome or Marfan's syndrome.
* Metabolic disorders.
* Previous knee surgeries.
* Cartilage and bone fractures in the knee.
* No consent for examination from the legal guardian.

Primary outcomes:
measure: Patients with recurrent patellar dislocation
timeFrame: 2022-2023
measure: Control group without obvious joint hipermobility
timeFrame: 2022-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Krzysztof Małecki
state: Lodzkie Voivodeship
city: Łódź
country: Poland
facility: Krzysztof Małecki
state: Lodzkie Voivodeship
Study officials:
affiliation: PMMHRI
name: Krzysztof Małecki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00751608: Effect of APL180 on Endothelial Function in Familial Hypercholesterolemia Patients
Official title: A Randomized, Double-blind, Placebo-controlled Ascending Dose Study to Evaluate the Effect of APL180 on Endothelial Function in Patients With Familial Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Familial Hypercholesterolemia
Keywords: Familial hypercholesterolemia, endothelial function, venous occlusion plethysmography, forearm blood flow, ApoAI-mimetic, endothelial dependent vasodilation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the effect of APL180 on endothelial function measured by forearm venous occlusion plethysmography in patients with familial hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Confirmed presence of familial hypercholesterolemia
* Women must be sterilized or post-menopausal

Exclusion Criteria:

* Smoking an average of greater than 10 cigarettes per day
* History of cardiac events
* Very low or high body weight
* Treatment with fibrates or niacin
* High blood triglyceride levels

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Change in forearm blood flow during each treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03913208: Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles
Official title: Priority to Cryopreservation Strategy (PCS) in IVF-ICSI Cycles is it Going to Make the Difference?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
IVF
ICSI
Cryopreservation
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicentre randomized controlled trial will be done to evaluate a new strategy in IVF-ICSI practice that gives that priority to freeze for the embryos and goes to fresh embryo transfer only if at least one set of same quality embryos is available for cryopreservation.

Detailed description: This study will be a non-blind, prospective, double-armed, randomized clinical trial. The study will be conducted at five centers, the Educational Hospital Fertility Unit of Tanta University, the fertility center of Cairo University, the fertility center of Assiut University, the Egyptian Consultants Fertility Center in Tanta, and MRC fertility center in Cairo from May 1st 2019 till the end of the objected number. The study will be conducted in accordance with the Declaration of Helsinki, and all participants should sign a written informed consent before inclusion in the study.

Eligibility criteria: Inclusion Criteria:

* Candidates for IVF/ICSI
* Presence of good number of embryos \> 5

Exclusion Criteria:

* Low quality embryos
* Low ovarian reserve
* Low number of embryos

Primary outcomes:
measure: Cumulative pregnancy rates
timeFrame: 3 months
Secondary outcomes:
measure: Failure of pregnancy
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
Study officials:
affiliation: Tanta Universit
name: Ahmed Elhalwagy, MD
role: STUDY_DIRECTOR
affiliation: Mansiura University
name: Yaser Mesbah, MD
role: STUDY_CHAIR
affiliation: Assiut University
name: Ahmed Abbas, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Ahmed Elsawaf, MD
role: STUDY_CHAIR
affiliation: Tanta University
name: Shereef Elshowaikh, MD
role: STUDY_CHAIR
affiliation: Tanta University
name: Abdelghaffar Dawood, MD
role: STUDY_CHAIR
affiliation: Tanta University
name: Ahmed Elkhyat, MD
role: STUDY_CHAIR
affiliation: Tanta University
name: Shereen Elbohoty, MD
role: STUDY_CHAIR
affiliation: Tanta University
name: Waleed Mamdouh, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Mahmoud Soliman, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Waleed Tawfeek, MD
role: STUDY_CHAIR
affiliation: Benha University
name: Ahmed Saber, MD
role: STUDY_CHAIR
affiliation: Zagazig University
name: Amr Abdelrahman
role: STUDY_CHAIR
References:
Clinical trial NCT03857308: Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
Official title: Eudaimonia and Sleep: Effects of a Mindfulness Intervention in Caregivers of People With Dementia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Caregivers
Burnout
Sleep
Keywords: well-being
sleep
caregiver
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 9
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study seeks to understand how stress reduction training influences caregiver well-being, sleep, and physiological responses to stress. All participants are caregivers of persons with dementia. Participants will complete a 14-day, online stress-reduction intervention which involves approximately 25-30 minutes of daily practice.

Detailed description: The research project will be conducted over approximately 9 months and will consist of three data collection sessions for each participant. The three data sessions will occur before, after, and at 3-month follow-up of an 14-day, online stress-reduction training, in which participants will be asked to complete about 25 to 30 minutes of practice each day in one of two stress-reduction techniques. Participants will be randomly assigned to either a mindfulness training program or a reappraisal training program. The mindfulness training emphasizes mindfulness-based techniques to reduce stress and promote well-being, whereas the reappraisal training emphasizes cognitive strategies to change one's perception of the stressor as a way to reduce stress and promote well-being.

Eligibility criteria: Inclusion Criteria:

* English speaking
* Self-reporting informal caregivers of persons with dementia

Exclusion Criteria:

* Self-reported major depressive disorder with psychotic features
* History of schizophrenia
* Bipolar disorder
* Uncorrected severe sensory impairments or chronic debilitating health problems that could hinder participating in the interventions
* Previous MBSR training or regular meditative practice within previous 6 months

Primary outcomes:
measure: Change in Eudaimonic well-being
timeFrame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
measure: Change in Sleep Quality
timeFrame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
measure: Change in Sleep Quality: Actigraph
timeFrame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Secondary outcomes:
measure: Change in Relationship Quality
timeFrame: Baseline to 2-weeks (post-intervention), and 3-month follow-up
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Joseph Dzierzewski, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06310408: Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate
Official title: Comparison Between Nasal Mask vs Nasal Prong on Pain Response in Neonate
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nasal Mask
Nasal Prong
Keywords: nasal mask, nasal prong, pain response
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 44
Sex: ALL
Minimum age (years): 26
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1 group give nasal mask

1 group give nasal prong
Primary purpose: PREVENTION

Brief summary: to determine the comparison of nasal masks and nasal prongs on the pain response of neonate

Detailed description: To see the comparison of nasal masks and nasal prongs on the pain response of neonates, by measuring salivary cortisol levels before and after the intervention

Eligibility criteria: Inclusion Criteria:

* Newborn with espiratory distress and need noninvasive respiratory support

Exclusion Criteria:

* Syok, multiple congenital anomaly

Primary outcomes:
measure: pain response
timeFrame: 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05990608: Peabody Developmental Motor Scaling In Children With Period Duchenne Muscular Dystrophy
Official title: The Validity and Reliability of The Peabody Developmental Motor Score In Children With Preschool Duchenne Muscular Dystrophy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duchenne Muscular Dystrophy (DMD)
Keywords: Duchenne Muscular Dystrophy (DMD)
Peabody Developmental Motor Scales-2
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 48
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Ondokuz Mayıs University, Health Application and Research Center, Pediatric Neurology Outpatient Clinic and community samples

Brief summary: To perform the reliability and validity study of the Peabody Developmental Motor Scale (Peabody Developmental Motor Scales-2) in children with Duchenne Muscular Dystrophy (DMD).


Eligibility criteria: Inclusion Criteria:

* for Group I:

  * No neurodevelopmental problems or diseases
  * 3-5 years old
  * Being able to cooperate with the instructions given by the physiotherapist.
  * Children who volunteered to participate in the study and whose families gave consent form will be included in the study.
* for Group II:

  * Being diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist
  * 3-5 years old
  * Children who volunteered to participate in the study and whose parents' consent was obtained will be included in the study.

Exclusion Criteria:

* Children with a behavioral condition and any disorder that interferes with testing (eg autism spectrum disorder)
* Failure to cooperate with the physiotherapist who made the evaluations.
* Lack of volunteers.

Primary outcomes:
measure: Peabody Developmental Motor Scales-2
timeFrame: This assessment will take place over the course of the study started and to the finish time
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayıs University
Study officials:
affiliation: Ondokuz Mayıs University
name: Deniz Çakır
role: PRINCIPAL_INVESTIGATOR
References: