louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06449573: Evaluation of Cardiopulmonary Parameters in Individuals With Asthma
Official title: Evaluation of Cardiopulmonary Parameters in Individuals With Asthma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include asthma patients followed up by Hacettepe University Faculty of Medicine, Department of Chest Diseases, Immunology and Allergy Branch and healthy individuals.

Brief summary: The aim of the study compare the cardiopulmonary parameters of individuals with asthma with healthy subjects.

Detailed description: It is thought that aerobic capacity of asthmatic individuals decreases due to chronic respiratory disease, especially oxygen consumption. Detailed investigation will be provided with this research.

Eligibility criteria: Inclusion Criteria:

* No respiratory, cardiovascular and metabolic diseases
* Regular non-smoker

Exclusion Criteria:

* Non-consenting
* Pregnant women

Primary outcomes:
measure: Exercise capacity
timeFrame: 20 minutes
Secondary outcomes:
measure: Respiratory muscle strength
timeFrame: 8 minutes
measure: Peripheral muscle strength
timeFrame: 5 minutes
measure: Grip strength
timeFrame: 3 minutes
measure: Kinesiophobia
timeFrame: 3 minutes
measure: Quality of Life (symptoms, mood, activity limitation, environmental exposure)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Hacettepe University
name: Naciye Vardar Yagli
role: STUDY_DIRECTOR
affiliation: Hacettepe University
name: Melda Saglam
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ebru Damadoglu
role: STUDY_CHAIR
affiliation: Kirsehir Ahi Evran Universitesi
name: Merve Firat
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Aydan Aslı Aksel Uylar
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Melek Cihanbeylerden
role: STUDY_CHAIR
References:
Clinical trial NCT01691573: European Pediatric Catheter Ablation Registry
Official title: European Pediatric Catheter Ablation Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiac Arrhythmias
Keywords: ablation
procedure
pediatric
european
cardiac
arrhythmias
registry
observational
prospective
catheter
cryoablation
atrioventricular
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2012-09-24
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: European pediatric population

Brief summary: The main objective of the European Pediatric Catheter Ablation Registry is to collect data on ablation procedures in the European pediatric population in order to improve the management of this subset of patients.

Detailed description: Catheter ablation has revolutionized the management of cardiac arrhythmias in patients and has become first-line therapy for managing many pediatric patients with atrioventricular accessory pathway or atrioventricular nodal-mediated supraventricular tachycardia.

Cardiac ablation in children is not a standardized procedure as in adults as evidence gaps still have to be filled. On a European perspective, lack of a dedicated scientific society has limited so far the collection and sharing of data among the most experienced centers.

Actually there are no sufficient data available about the management of pediatric patients undergoing ablation in clinical practice, in particular regarding indications, methodology and clinical follow-up.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients scheduled to any kind of an ablation procedure;
* Patient´s age between 0 and 18 years;
* Legal guardians understand the nature of the procedure, are willing to comply with study follow-up evaluations, and provide written informed consent prior to the procedure.

Exclusion Criteria:

* Patient unable to comply with follow-up schedule;
* Patient has medical conditions that preclude protocol compliance or limit study participation;
* Legal guardian or patient unwilling or unable to provide informed consent.

Primary outcomes:
measure: To collect data on ablation procedures in the European pediatric population.
timeFrame: After 12 months from the ablation procedure
Secondary outcomes:
measure: To describe and compare different ablation methodologies
timeFrame: After 12 months from the ablation procedure
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: University Hospital Motol
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Bergamo
country: Italy
facility: Ospedali Riuniti di Bergamo
state: BG
city: Lecco
country: Italy
facility: Ospedali Manzoni
state: LE
city: Milano
country: Italy
facility: Ospedale S. Raffaele
state: MI
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Ospedale Manzoni, Via dell'Eremo 9/11 23900 Lecco, Italy.
name: Francesco Cantù, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00710931: Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Official title: Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: Bilateral Cataract
IOL
ReSTOR
Aspheric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 35
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).


Eligibility criteria: Inclusion Criteria:

* Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

* Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.

All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Primary outcomes:
measure: Binocular Visual Acuity at Distance, Near and Intermediate
timeFrame: 6 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT02805231: Associations of Vitamin D Receptor ApaI and Tru9I Polymorphisms With the Risk of Primary Open-angle Glaucoma
Official title: Associations of Vitamin D Receptor Polymorphisms With the Risk of Primary Open-angle Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open- Angle Glaucoma
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
Collaborators: name: Tianjin Medical University Eye Hospital
First posted: 2016-06-17
Enrollment: 300
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary open-angle glaucoma patients and randomly age-matched people as controls in the Han population of Tianjin China

Brief summary: This study investigated whether vitamin D receptor gene polymorphism is altered in primary open-angle glaucoma subjects carrying the risk allele.Primary open-angle glaucoma patients and age-matched people in the Han population were enrolled. Vitamin D receptor polymorphic analysis was studied by polymerase chain reaction-restriction fragment length polymorphism technique.


Eligibility criteria: Inclusion Criteria:

* intraocular pressure greater than 22 mmHg with two or more medications wide anterior chamber angle glaucomatous optic neuropathy (Glaucomatous optic nerve damage was defined as cup-to-disc ratio higher than 0.7 or focal loss of the nerve fiber layer (notch) associated with a consistent glaucomatous visual field defect) visual field loss consistent with optic nerve damage and visual fields were performed by using standard automated perimetry

Exclusion Criteria:

* the presence of any secondary glaucoma including exfoliation syndrome or a history of ocular trauma high myopia macular degeneration other ocular diseases a known history of systemic diseases and administration of vitamin D3 or other analog

Primary outcomes:
measure: gene polymorphisms of vitamin D receptor
timeFrame: 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Eye Hospital
state: Tianjin
Study officials:
References:
Clinical trial NCT05717231: The Effect of Laughter Yoga on Tex Anxiety and Educational Stress
Official title: The Effect of Laughter Yoga on Tex Anxiety and Educational Stress in 8th-Grade Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laughter Therapy
Anxiety
Stress, Exam
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 64
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to examine the effects of laughter therapy on tex anxiety and educational stress in 8th-grade students.


Eligibility criteria: The inclusion criteria of the study were determined as being an 8th-grade student, speaking and understanding Turkish, and being able to perform daily life activities.

The exclusion criteria of the study were to have undergone a surgical operation in the last three months, and to have uncontrollable blood pressure, diabetes and asthma.

Primary outcomes:
measure: Westside Test Anxiety Scale
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Educational stress
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Bilge KALANLAR
Study officials:
References:
Clinical trial NCT00449631: Multidrug Resistance After Trabeculectomy With Mitomycin C
Official title: Multidrug Resistance After Trabeculectomy With Mitomycin C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Trabeculectomy
Keywords: Glaucoma
Drug Resistance, Multiple
Trabeculectomy
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 30
Sex: ALL
Minimum age (years): 8
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: We investigate whether mitomycin C treatment during previous filtration surgery induces P-glycoprotein expression.

Detailed description: Despite the adjuvant use of mitomycin C during trabeculectomy, short-term and long-term failures still occur. We investigate whether mitomycin C treatment during previous trabeculectomy induces P-glycoprotein expression. Expression of P-glycoprotein is analysed in surgically removed Tenon tissue using immunohistochemistry.

Eligibility criteria: Inclusion Criteria:

* patients with planned trabeculectomy for elevated eye pressure
* one third of patients without previous trabeculectomy
* two thirds of patients with previous trabeculectomy (one third with and one third without the use of mitomycin C)

Exclusion Criteria:

* patients not requiring surgery
* patients with planned surgery for elevated eye pressure other than trabeculectomy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: The University Hospital of Cologne
Study officials:
affiliation: University of Cologne
name: Arno Hueber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hueber A, Esser JM, Kociok N, Welsandt G, Luke C, Roters S, Esser PJ. Mitomycin C induces multidrug resistance in glaucoma surgery. Graefes Arch Clin Exp Ophthalmol. 2008 Feb;246(2):297-304. doi: 10.1007/s00417-007-0695-1. Epub 2007 Oct 13.
Clinical trial NCT06083831: The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients
Official title: The Effect of Sequential Feeding for Circadian Rhythm and Gut Flora Rhythm in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Feeding Patterns
Critical Illness
Circadian Rhythm Disorders
Lead sponsor: Qingdao University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: Circadian rhythms plays an important role for healthy. And critical illness contributes to the disruption of circadian rhythms. Not only right but also feeding can affect the circadian clock gene expression. In a investigators' previous study, some metabolic indicators (the albumin level, total cholesterol level and total bile acid level) and the increases in lymphocyte counts in the sequential feeding group were different from those in the continuous feeding group. Investigators think sequential feeding may adjust circadian clock gene expression for its effect on metabolism and immunity. Moreover, sequential feeding did alter the abundances of some gut microbes to some degree in the investigators' previous study. Investigators think sequential feeding may adjust gut flora rhythms.


Eligibility criteria: Inclusion Criteria:

* Patients newly admitted to ICU were eligible for inclusion.

Exclusion Criteria:

* An estimated feeding time of less than 10 days in ICU;
* Diabetes;
* Gastrointestinal disease (gastrointestinal surgery, gastrointestinal bleeding, pancreatitis, Crohn's disease, ulcerative colitis, irritable bowel syndrome);
* Inability to tolerate ≥80% of the nutrition target calories (25-30 kcal/kg/d) with enteral feeding through gastric tube;
* The ability to eat orally at admission.

Primary outcomes:
measure: clock genes expression
timeFrame: 7 days feeding
measure: Gut Flora Rhythm
timeFrame: 7 days feeding
Secondary outcomes:
Other outcomes:
Locations:
city: Qingdao
country: China
facility: The affiliated hospital of qingdao university
state: Shan Dong Province
Study officials:
affiliation: The Affiliated Hospital of Qingdao University
name: bo yao, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04700631: Extracellular Vesicles as Biomarkers for Chronic Renal Failure
Official title: Extracellular Vesicles as Biomarkers for Chronic Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Renal Failure
Urinary Extracellular Vesicle
Keywords: urinary extracellular vesicle
Chronic Renal Failure
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The recent discovery of extracellular vesicles (EV) as a mechanism of intercellular communication has made it possible to develop a new field of health research and could bring new information on the pathological mechanisms of renal diseases. Definition of physiologic and pathologic values of urinary extracellular vesicles (EVu) between healthy subjects and chronic kidney diseases (CKD) patients could be a new tool for follow up of renal diseases. EV are found in all biological fluids including urine, that's why they are increasingly analyzed in renal pathologies. The main objective of this study is to determine the physiological values and the pathological thresholds of EVu.


Eligibility criteria: Inclusion Criteria:

* subject \> 18 years old
* healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI
* CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m²

Exclusion Criteria:

* patients under dialysis protocols
* renal transplant patients

Primary outcomes:
measure: variation of urinary extracellular vesicle concentration between both groups
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT02220231: Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation
Official title: Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mediastinal Tumors
Keywords: mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-19
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography.

Detailed description: Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with one-lung ventilation during VATET may cause hemodynamic instability due to the compression of intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax on the pulmonary blood flow and cardiac function during the VATET by using the transesophageal echocardiography

Eligibility criteria: Inclusion Criteria:

1. Above 20 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
3. Thoracic surgical procedure (video-assisted thoracoscopic extended thymectomy )

Exclusion Criteria:

1. Severe functional liver or kidney disease
2. Diagnosed HF ( NYHA class \>3)
3. Arrhythmia or received treatment with antiarrhythmic drug .
4. Exceed BMI \> 30 kg/ m2
5. COPD
6. Pathologic esophageal lesion (esophageal stricture or varix )
7. Pregnancy

Primary outcomes:
measure: The changes of the echocardiographic indices
timeFrame: four time points during the operation. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
Secondary outcomes:
measure: The changes of the oxygenation and respiratory dynamic parameters
timeFrame: four time points during the operation, an expected average of 3 hours. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04976231: MPS II Immunophenotyping
Official title: Immunophenotyping of Patients With MPS II Treated With Enzyme Replacement Therapy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: MPS II
Mucopolysaccharidosis II
Hunter Syndrome
Keywords: MPS II
Mucopolysaccharidosis II
Hunter Syndrome
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Metabolic or Genetics Clinic patients

Brief summary: The purpose of this study is to investigate how participant's body's immune system responds to idursulfase, an enzyme replacement therapy (ERT) and find out which types of immune cells are involved in causing untoward responses to the ERT so that the investigators can relate the level of immune response to the treatment.


Eligibility criteria: Inclusion Criteria:

* Subject has a confirmed diagnosis of Mucopolysaccharidosis type II (MPS II) or Hunter Syndrome based on enzyme activity and variant analysis.
* Subject who plan to receive or have received enzyme replacement therapy with idursulfase.

Exclusion Criteria:

* None

Primary outcomes:
measure: Changes in the frequency of natural killer cells measured by flow cytometry
timeFrame: baseline, 1, 3, 6 months
measure: Changes in level of circulation memory B cells measured by flow cytometry
timeFrame: baseline, 1, 3, 6 months
measure: Changes in level of T follicular helper cells measured by flow cytometry
timeFrame: baseline, 1, 3, 6 months
measure: Changes in distribution of helper T cells measured by flow cytometry
timeFrame: baseline, 1, 3, 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Priya Kishnani, MD
role: PRINCIPAL_INVESTIGATOR
References: