louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05076162: Vitamin D Level and Emergence Delirium in Children
Official title: Evaluation of the Relationship Between Vitamin D Level and Emergence Delirium in Children Undergoing Tonsillectomy and/or Adenoidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-10-13
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This was a prospective, single-center, double-blind, randomized study. The primary outcome was the presence or absence of presenting delirium with or without vitamin d deficiency.

Secondary outcomes, postoperative additional need analgesia. Children aged 2-10 years, ASA (American Society of Anesthesiologists) physical I or II scheduled for tonsillectomy were eligible, with or without adenoidectomy.

Brief summary: In our study, we aimed to evaluate the relationship between vitamin D levels and postoperative delirium in children who had undergone tonsillectomy and/or adenoidectomy.

Detailed description: Patients are assigned to one of two groups. Serum 25(OH)D level will be determined as \<12 ng/ml group 1, group 2 with ≥12 ng/ml. ASA I-II children aged 2-10 years who will undergo adenoidectomy and/or tonsillectomy surgery under general anesthesia will be included in the study. In the operating room, the patient will monitored using electrocardiography, pulse oximetry, noninvasive blood pressure measurements, capnography. Under anesthesia, blood samples were taken for serum 25(OH)D levels. After extubation, patients will be taken to the recovery room. Delirium will be evaluated using the PAED (Pediatric Anesthesia Emergence Delirium) scale at 10-minute intervals in the recovery unit. In our study, 25(OH)D level was measured.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II Tonsillectomy and/or Adenoidectomy Surgery

Exclusion Criteria:

* psychological disorders
* emotional disorders
* abnormal cognitive development
* developmental delay
* allergy to the drugs in our protocol

Primary outcomes:
measure: The scale of emergence delirium
timeFrame: up to 30 minutes after arrival in postanesthetic care unit
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Aydın Adnan Menderes University Faculty of Medicine, Department of Anesthesiology and Reanimation
Study officials:
affiliation: institutional affiliation
name: Sinan Yılmaz
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332862: Continuous Versus Discontinuous Design of Encircling Lesions During Ablation for Atrial Fibrillation
Official title: Acute Efficacy of Point-by-point Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation: a Randomized Comparison of Continuous Versus Discontinuous Design of Encircling Lesions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Catheter Ablation
Atrial Fibrillation
Contact Force
Continuous Ablation
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Charles University, Czech Republic
name: 3rd Department of Internal Medicine - Cardiology
First posted: 2017-11-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute efficacy of point-by-point radiofrequency ablation for pulmonary vein isolation in patients with atrial fibrillation are comparable independantly of the ablation strategy (continous versus discontinuous ablation) under the same condition of power delivery.

Detailed description: The number of pulmonary vein isolation (PVI) therapy for atrial fibrillation (AF) is increasing. Durable PVI is cornerstone for long-term freedom of AF. In one previous study continuous ablation was suggested to be more efficient in durable PVI. However, this hypothesis has not been proven in randomized fashion.

The current study is to confirm whether continuous versus discontinuous design of encircling lesions are comparable under the same conditions of power delivery.

The study design is a two-centre prospective randomized trial to compare the acute efficacy by using the above described approaches.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing pulmonary vein isolation with radiofrequency catheter ablation for paroxysmal atrial fibrillation treatment.

Exclusion Criteria:

-

Primary outcomes:
measure: Combined unsuccessful PVI or PV reconnection
timeFrame: 30 min after ablation
Secondary outcomes:
measure: Early pulmunary veins reconnection
timeFrame: 10 min.
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: Institute for Clinical and Experimental Medicine
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Bashar Aldhoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aldhoon B, Peichl P, Osmancik P, Konecny P, Kautzner J, Wichterle D. Acute efficacy of contiguous versus temporally discontiguous point-by-point radiofrequency pulmonary vein isolation in patients with paroxysmal atrial fibrillation: a randomized study. J Interv Card Electrophysiol. 2022 Sep;64(3):661-667. doi: 10.1007/s10840-021-01113-9. Epub 2022 Jan 6.
Clinical trial NCT05109962: Management of Robertsonian Translocation PGT-SR Attempts
Official title: New Recommendations for Robertsonian Translocation Management After Preimplantation Genetic Testing of Structural Rearrangement (PGT-SR) Attempts: What Should be Done With Mosaic Embryos?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robertsonian Translocation
Keywords: Several years of miscarriages
Abortions and primary infertility
FISH with 2 probes
FISH with 3 probes
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 148
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: Robertsonian translocation carriers are phenotypically normal, but they are known to be at increased risk of repeated miscarriages compared with the general population estimated at about 15% of pregnancies, and also resulting in the birth of a child with congenital anomalies or a mental retardation.

Brief summary: to analyze if a probe strategy choice for PGT-SR studies of Robertsonian translocations (RT) influences the fate of embryos? Few studies discussed the importance of probe choices. However, those who did, demonstrated that analysis with locus specific probes improve a diagnosis of dubious results, and addition of a centromeric probe could affect the accuracy of diagnosis


Eligibility criteria: Inclusion criteria:

* Adult patient whom carrying robertsonian translocations in the context of PGT-SR management
* age \> 18 years

Exclusion criteria:

- age \< 18 years

Primary outcomes:
measure: Number of Participants with detect all chromosome segments
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Reda Zenagui, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02981862: CaptHPV : Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas
Official title: Monocentric Study of Validation of the Method "CaptHPV" for the Diagnosis of Human Papillomavirus Associated Infiltrating Carcinomas From a Biological Specimen.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Vulvar Cancer
Anal Cancer
Oropharynx Cancer
Oral Cavity Cancer
Penis Cancer
Keywords: HPV infection
Blood sample
Biopsy
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The current project is based on the assumption that a diagnosis of human papillomavirus associated Infiltrating Carcinomas can be made from a blood sample for patient with Cervical Cancer, Vulvar Cancer, Anal Cancer, Oropharynx Cancer, Oral Cavity Cancer or Penis Cancer at any stage of the disease and including surgical treatment for the small tumors.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Patient with cervical cancer, vulvar cancer, anal cancer, oropharynx cancer, oral cavity cancer or penis cancer
* Patient naive of any treatment for this pathology
* Patient capable and willing to follow all procedures of the study in accordance with the study
* Ability to provide an informed written consent form
* Affiliation to a social security system

Exclusion Criteria:

* Patients who have already undergone surgical treatment leading to complete removal of the lesions or who have started treatment with radiotherapy and / or chemotherapy
* Patient whose health status contraindicates a blood sample of 20 ml,
* Absence of informed written consent form
* Pregnant or breast feeding females
* Patients deprived of liberty or under supervision

Primary outcomes:
measure: Assessement of CaptHPV method
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Institut de Cancérologie de Lorraine
name: SASTRE-GARAU Xavier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sastre-Garau X, Diop M, Martin F, Dolivet G, Marchal F, Charra-Brunaud C, Peiffert D, Leufflen L, Dembele B, Demange J, Tosti P, Thomas J, Leroux A, Merlin JL, Diop-Ndiaye H, Costa JM, Salleron J, Harle A. A NGS-based Blood Test For the Diagnosis of Invasive HPV-associated Carcinomas with Extensive Viral Genomic Characterization. Clin Cancer Res. 2021 Oct 1;27(19):5307-5316. doi: 10.1158/1078-0432.CCR-21-0293.
Clinical trial NCT01181362: Comparing Head and Neck Endoscopy Procedures
Official title: A Feasibility Study Comparing Head And Neck Endoscopy Procedures In The Upright And Supine Positions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Comparing Head And Neck Endoscopy in Healthy Patients
Keywords: Endoscopy
Head and Neck region
Scope
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 10
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
Primary purpose: DIAGNOSTIC

Brief summary: Intensity Modulated Radiation Therapy planning is based on CT images, with tumour volumes defined on this volumetric information data set. However, target delineation also depends on disease seen endoscopically which may not be visible on CT. We are developing imaging and tracking technology to improve target delineation in Radiation Therapy (RT) planning for head \& neck cancer using quantitative registration of 2D endoscopic information with CT data. Diagnostic endoscopy is performed in the upright position. CT images and radiation delivery are obtained with the patient in the supine position. The accuracy of the registration will be improved if performed in the same position to prevent mobile soft tissue structures shifting between the upright and supine positions. Since therapy must be performed in the supine position, we intend to check the feasibility of performing endoscopy in the supine treatment position. We will compare and assess patient comfort and endoscopic sightlines during an endoscopy procedure in both the upright and supine positions.


Eligibility criteria: Inclusion Criteria:

* Between 18-70 years of age.
* Willing to give informed consent.

Exclusion Criteria:

* Allergy to topical anesthetic nasal spray (lidocaine).
* Patients who currently have or have had head and neck cancer.
* Currently pregnant or lactating; or serious co-morbid illness (e.g., cardiovascular, pulmonary).
* Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol.
* Concurrent illness, which prevents the subject from undergoing endoscopy.
* Disorders of the nasal cavity e.g deviated septum

Primary outcomes:
measure: To compare and assess subject comfort and adequacy of endoscope sightlines during an endoscopy procedure in both the upright and supine positions.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: John Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00073762: Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Two Fixed Doses (200 Mg, Or 400 Mg) Of DVS-233 SR In Adult Outpatients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-12-08
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item \[HAM-D17\] less than or equal to 7) versus those subjects receiving placebo.


Eligibility criteria: Inclusion Criteria:

* Outpatients
* Sexually active women participating in the study must use a medically acceptable form of contraception
* Subjects must have a primary diagnosis of major depressive disorder of 4 on Clinical Global Impressions-Severity scale (CGI-S)

Exclusion Criteria:

* Treatment with DVS-233 SR at any time in the past
* Treatment with venlafaxine (immediate release \[IR\] or extended release \[ER\]) within 90 days of study day 1
* Known hypersensitivity to venlafaxine (IR or ER)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Thase ME, Fayyad R, Cheng RF, Guico-Pabia CJ, Sporn J, Boucher M, Tourian KA. Effects of desvenlafaxine on blood pressure in patients treated for major depressive disorder: a pooled analysis. Curr Med Res Opin. 2015 Apr;31(4):809-20. doi: 10.1185/03007995.2015.1020365. Epub 2015 Mar 26.
Clinical trial NCT05819762: Evaluation of ClearLLab LS Screening Panel
Official title: Evaluation of ClearLLab LS Screening Panel for the Diagnosis of Hematological Malignancies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Malignancy
Hematologic Neoplasms
Hematologic Diseases
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Institute of Hematology & Blood Diseases Hospital, China
name: The First Affiliated Hospital of Soochow University
name: The First Affiliated Hospital with Nanjing Medical University
name: Tongji Hospital
First posted: 2023-04-19
Enrollment: 831
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects of any ethnicity, age and racial background will be included

Brief summary: This is a multi-center study to evaluate the clinical performance of ClearLLab LS screening panel with specimens from subjects for the diagnosis of hematologic malignancies.

Detailed description: This study aims to evaluate the clinical accuracy of ClearLLab LS screening panel in the diagnosis of hematologic malignancies. The residual specimens, which from subjects presenting to the flow cytometry laboratory as part of their standard of care for hematologic diseases work-up, will be tested by ClearLLab LS screening panel. ClearLLab LS screening panel is CE-IVD marked immunophenotyping reagents under the European Union (EU) regulation, and this study is aimed to validate its clinical performance in Chinese population.

Eligibility criteria: Inclusion Criteria:

* Residual whole blood, bone marrow, or lymph node tissue samples from subjects with hematologic tumor-related symptoms and/or signs that are clinically recommended for Flow Cytometry Immunophenotyping

Exclusion Criteria:

* Specimens and/or spent samples that are visibly hemolyzed
* Specimens and/or spent samples that are visibly clotted
* Specimens and/or spent samples collected in Ethylene Diamine Tetraacetic Acid (EDTA) anticoagulant older than 24 hours from time of collection
* Specimens and/or spent samples collected in Heparin or Acid Citrate-Dextrose (ACD) anticoagulant older than 48 hours from time of collection
* Samples with insufficient volume to complete the protocol tests
* Samples from subjects with known myeloid malignancies or multiple myeloma

Primary outcomes:
measure: Diagnostic accuracy: sensitivity and specificity
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Study officials:
affiliation: Beckman Coulter, Inc.
name: China Clinical Affaris
role: STUDY_DIRECTOR
References:
Clinical trial NCT00736762: Effects of Global Postural re-Education Program
Official title: Effects of Global Postural re-Education Program on the Biomechanical Characteristics of the Elderly Balance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Elderly
Keywords: Global postural re-education
Balance
Physical therapy
older people
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2008-08-18
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The postural alterations present in the seniors people act as predisponent form of incapacities that provoke alterations in the quality of life. The objective of this study is to evaluate the biomechanical characteristics of the balance of elderly people, before and after treatment with Global Postural Re-education. This research is characterized by experimental method of investigation.Thirty elderly people (30 women) will be randomized to two different groups from Group of Studies of Third Age - GETI, at University of the State of Santa Catarina:

* fifteen elderly women will be submitted to the Global Postural Re-education (GPR) program and to the GETI program of activities
* fifteen elderly women will be submitted only to the GETI program of activities.

At baseline the subjects will be screened for balance measurements with the chattecx balance system and Berg Scale. These measurements will be repeat immediately after the intervention. The subjects randomised to the GPR program will participate in posture retraining techniques of approximately forty minutes, one time a week for ten weeks. The independent t test for pairs of random samples will be used, with level of significance of p≤0,05.


Eligibility criteria: Inclusion Criteria:

* Senior that accomplish physical activity in the GETI (group of studies of the third age - Santa Catarina State University)

Exclusion Criteria:

* Visually impaired person
* Vestibular disorder
* Neurologic disorders
* Use of prostheses and ortheses
* Cancer

Primary outcomes:
measure: center of pressure (cop)
timeFrame: pre-treatment, five weeks and pos-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Florianópolis
country: Brazil
facility: Santa Catarina State University
state: Santa Catarina
Study officials:
affiliation: Santa Catarina State University
name: Gilmar Santos, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06110962: Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor
Official title: Detecting Heart Rate, Respiration, and Sleep With the Sleeptracker-AI Under-mattress Monitor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: OSA
Keywords: validation study
Sleeptracker-AI
polysomnography
Lead sponsor: Woolcock Institute of Medical Research
Sponsor class: OTHER
Collaborators: name: Fullpower Technologies, Inc.
First posted: 2023-11-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the Woolcock Institute for a diagnostic sleep study for possible sleep apnea.

Brief summary: The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA).

Detailed description: The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA). The de-identified Sleeptracker and PSG data will then be used by Fullpower Technologies to improve the accuracy of their current algorithm for detecting sleep and breathing disorders using the Sleeptracker device.

De-identified data recorded from the Sleeptracker device and PSG data from the Compumedics Grael system will be manually uploaded to a secure commercial server maintained by Fullpower Technologies.

Fullpower Technologies will use the de-identified data to refine their algorithms for detecting sleep and breathing disturbances.

Eligibility criteria: Inclusion Criteria:

* Adults aged 20-90 years old at time of assessment.
* Attending the Woolcock Institute for an overnight sleep study for investigation of sleep apnoea.
* Able to give informed consent.
* Fluent in English.

Exclusion Criteria:

* Unable to understand study procedure.
* Unable to sign informed consent form.

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: One night
Secondary outcomes:
measure: Total Sleep Time
timeFrame: One night
measure: NREM Sleep Time
timeFrame: One night
measure: REM Sleep Time
timeFrame: One night
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Woolcock Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Woolcock Institute of Medical Research
name: Craig Phillips, PhD
role: PRINCIPAL_INVESTIGATOR
References: