louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06579586: Parental Anxiety and Postoperative Pain and Complications in Children Undergoing Tonsillectomy ± Adenoidectomy
Official title: The Relationship Between Parental Anxiety and Postoperative Pain and Complications in Children Undergoing Tonsillectomy ± Adenoidectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parents
Anxiety
Complication of Surgical Procedure
Pain
Keywords: Parental anxiety
Tonsillectomy
Postoperative pain
Complication of tonsillectomy
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 145
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 4-15 years, who had no history of psychiatric-mental illness or drug use in themselves or their parents, and who underwent tonsillectomy + adenoidectomy for chronic tonsillitis or sleep-disordered breathing were included in the study.

Brief summary: It is aimed to understand whether high parental anxiety leads to increased pain in children undergoing tonsillectomy ± adenoidectomy surgery and whether it increases the development of complications.


Eligibility criteria: Inclusion Criteria:

* 4-15 years old child patient
* Willingness to participate in the study by the patient and/or parent
* No history of psychiatric-mental illness or drug use in the patient and/or parents
* The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
* No bleeding disorder or disease

Exclusion Criteria:

* \<4 years old, \>15 years old paediatric patients
* Not wanting to participate in the study at any stage of the study
* History of psychiatric-mental illness or drug use in the patient and parents
* The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
* Having a bleeding disorder or disease

Primary outcomes:
measure: Evaluation the relationship between parents' anxiety level in the preoperative period and pain perception and complications in children undergoing tonsillectomy ± adenoidectomy
timeFrame: 14 days
measure: Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with State-Trait Anxiety Inventory
timeFrame: 21 days
measure: Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Anxiety Sensitivity Index-3
timeFrame: 21 days
measure: Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Pain Catastrophising Scale for Parents
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Etlik City Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Sumeyra Doluoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04339686: Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening.
Official title: Multicentric Retrospective Observational Study of Thoracic Scanner Performance in COVID Screening. Comparison to Virological Testing and Multiparametric Gold Standard
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: The Gold Standard for Current SARS CoV2 Detection is RT-PCR
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 56000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients suspected of COVID 19 consulting for diagnostic

Brief summary: All patients included in this search will be on anonymized file: Symptomatic patients consulting for suspicion of COVID 19 with indication to a screening (RT-PCR, Scanner) according to the criteria of the Ministry of Health.

To evaluate the diagnostic performance of chest CT in screening for COVID-related lung injury in patients with a clinical suspicion of COVID.

CT scan results for COVID according to French thoracic imaging society will be dichotomized into evocative or compatible (considered positive) non-evocative (considered negative) The results will be compared to the gold standard corresponding to a multiparametric element: the discharge summary.

Ct Scan performance will be recorded and analyzed.


Eligibility criteria: Inclusion Criteria:

* All patients suspected of COVID 19 consulting for diagnostic

Exclusion Criteria:

* Delay between RT-PCR and Thoracic Scan greater than 6 days.

Primary outcomes:
measure: Diagnostic performance of chest CT in screening for pulmonary lesions in clinical suspicions of COVID.
timeFrame: 1 month
Secondary outcomes:
measure: Compare the diagnostic performance of chest CT and RT-PCR in COVID 19 at the initial consultation (screening).
timeFrame: 1 month
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
References:
Clinical trial NCT06644586: Comparison of Video Laryngoscopy and Macintosh Laryngoscopy in Pediatric Patients Undergoing Elective Surgery
Official title: COMPARISON of VIDEO LARYNGOSCOPY and MACINTOSH LARYNGOSCOPY in PEDIATRIC PATIENTS UNDERGOING ELECTIVE SURGERY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Patients Undergoing Operation
Keywords: video laryngoscopy
direct laryngoscopy
pediatric patients
Lead sponsor: University of Gaziantep
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent elective surgery at Gaziantep University.

Brief summary: In this study, we aimed to observe the intubation conditions in patients using Endolarenx video laryngoscope and Macintosh Blade in laryngoscopy to identify the advantages and disadvantages of using video laryngoscopy in pediatric patients.


Eligibility criteria: Inclusion Criteria:

* One hundred pediatric patients, aged under 18 years, weighing between 10-40 kg, and classified as American Society of Anesthesiologists (ASA) I-II-III risk group

Exclusion Criteria:

* Patients with congenital airway deformities, patients with known or predicted difficult intubation, patients undergoing emergency surgery, patients classified above ASA III, and patients whose parents did not consent were excluded from the study

Primary outcomes:
measure: Mean intubation time
timeFrame: The time from the entry of the laryngoscope into the oral cavity until the appearance of the EtCO2 trace on the capnograph.
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep University
Study officials:
References:
Clinical trial NCT01033786: Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications
Official title: Recovery After Robotic Urogynecological Surgery: Hospital Stay and Perioperative Complications of Patients Who Did Not Complete Questionnaires
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urogynecology
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2009-12-16
Enrollment: 21
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who underwent DaVinci-assisted laparscopic surgery.

Brief summary: The purpose of this study is to assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.


Eligibility criteria: Inclusion Criteria:

* The first 21 women who underwent DaVinci-assisted robotic sacrocolpopexy and who did not complete postoperative QA questionnaires from 09/01/2007 through 09/01/2008.

Exclusion Criteria:

* Any women not meeting inclusion criteria.

Primary outcomes:
measure: To assess length of hospital stay and perioperative complications of patients undergoing daVinci Robot-assisted sacrocolpopexy, during a one-year time period, who did not complete a questionnaire on post-operative recovery.
timeFrame: 09/01/07 - 09/01/08
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Gunhilde Buchsbaum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01464086: LIFSCREEN : Evaluation of Whole Body MRI for Early Detection of Cancers in Subjects With P53 Mutation (Li-Fraumeni Syndrome)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Li Fraumeni Syndrome
Keywords: patients with Li Fraumeni syndrome
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2011-11-03
Enrollment: 107
Sex: ALL
Minimum age (years): 5
Maximum age (years): 71
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to compare the diagnostic efficacy of two follow-up schedules for the early detection of cancers in the population under study on cancer incidence at 3 years.


Eligibility criteria: Inclusion Criteria:

* P53 mutation

Primary outcomes:
measure: cancer incidence
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References:
citation: Caron O, Frebourg T, Benusiglio PR, Foulon S, Brugieres L. Lung Adenocarcinoma as Part of the Li-Fraumeni Syndrome Spectrum: Preliminary Data of the LIFSCREEN Randomized Clinical Trial. JAMA Oncol. 2017 Dec 1;3(12):1736-1737. doi: 10.1001/jamaoncol.2017.1358.
Clinical trial NCT04613986: Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat Coagulopathy and Inflammation in Severe Covid-19
Official title: Randomized, Prospective, Open-label, Controlled Parallel-group Trial Investigating the Efficacy of Therapeutic Plasma Exchange as an Adjunctive Strategy to Treat the Systemic Inflammatory Response Against SARS-CoV2 and the Associated Coagulopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Covid-19
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial to analyse adjuvant therapeutic plasma exchange (TPE) in severe Covid-19 associated coagulopathy and systemic inflammation compared to current standard of care (SOC).

A total of three TPEs (d1, 3, 5) will be performed in the intervention group. Primary endpoint is the reversibility of relative ADAMTS13 deficiency (indicated by the change in ADAMTS13 / VWF:Ag ratio from day 1 to 7).


Eligibility criteria: Inclusion Criteria:

* Proven SARS-CoV2 infection
* Severe Covid-19 (indicated by respiratory failure requiring invasive mechanical ventilation)
* Evidence of coagulopathy (indicated by D-dimer \> 10 mg/L)
* Evidence of systemic inflammation (CRP \> 100 mg/L , ferritin \> 500 ng/mL)

Exclusion Criteria:

* • Participation in another study with investigational drug within the 30 days preceding and during the present study,

  * Previous enrolment into the current study.
  * Extra corporeal membrane oxygenation (ECMO)

Primary outcomes:
measure: relative ADAMTS13 deficiency
timeFrame: day 1 to 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03780686: Dopamine and Norepinephrine Infusion With Restricted Hydration
Official title: The Effect of Adding Dopamine Infusion to Noradrenaline Infusion Combined With Restrictive Hydration on Renal Function and Tissue Perfusion During Open Abdominal Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Function Test, Urine Output, Lactate Level
Keywords: Restrictive hydration,
Dopamine,
Norepinephrine,
Serum lactate,
Standard hydration
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study was designed to assess the effect of adding dopamine infusion in addition to restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate levels as an indicator for tissue hypo perfusion and renal function in comparison to restrictive hydration combined with noradrenaline infusion only and standard hydration during open abdominal surgeries.

Detailed description: One hundred and twenty patients were randomly assigned into three groups (dopamine norepinephrine group, restrictive hydration group and liberal hydration group) undergoing open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was introduced according to maintenance, deficit for the first 3 hours (hours fasting x body weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).

The outcome to be assessed was serial measurements of serum lactate intraoperatively and immediate postoperatively as an index of tissue perfusion, in addition to blood pressure, heart rate and oxygen saturation.

Eligibility criteria: Inclusion Criteria:

* All patients with American Society of Anesthesiologists (ASA) physical status I or II
* Age range from 18-80 years scheduled to either radical cystectomy or hemicolectomy were contained in the study.

Exclusion Criteria:

* Patients with coagulopathies,
* Hepatic dysfunction (prothrombin ratio \<50%),
* Renal dysfunction,
* Congestive heart failure (New York Heart Association scores ≥3),
* Contraindications for epidural analgesia (e.g. patient refusal, local infection or coagulopathy), and peripheral vascular disease.

Primary outcomes:
measure: Changes in serum lactate level
timeFrame: Before induction of anesthesia and up to 12 hours after.
measure: Changes in renal function test
timeFrame: Before induction of anesthesia and up to 12 hours after.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT00366886: Patients With NMDA Biomarker Data Following Cardiac Surgery
Official title: Retrospective Review of 22 Patients With NMDA Biomarker Data Following Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: cardiac
pediatric
surgery
blood markers
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2006-08-21
Enrollment: 22
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The purpose of this current retrospective study is to perform follow-up analysis on the 22 children from the study # 621-2004 It is important to examine whether an elevated biomarker of brain ischemia before and/or following cardiac surgery has any clinical or functional implications as the child ages.

Detailed description: The N-Methyl-D-Aspartate (NMDA) receptor is unique to the brain. With brain injury or ischemia, fragments of the NMDA receptor (NR2) break off and appear in the bloodstream. These NR2 fragments generate an antibody response (NR2 ab) from the body. A recently developed blood test (CIS-Biotech, Inc) is able to measure these fragments (NR2) and the antibody (NR2 ab) response. In adult patients who suffer from ischemic stroke, elevated blood levels of NR2 ab correlate with the amount of brain damage on brain magnetic resonance imaging.

The purpose of the past prospective study, "Blood Markers of Brain Injury from Cardiopulmonary Bypass and Deep Hypothermic Circulatory Arrest in Infants and Children", Emory #621-2004, was to observe the expression of blood markers of brain ischemia, NMDA receptor fragment (NR2) and antibody (NR2 ab) in infants with congenital heart disease before and after cardiac surgery.

Our intent is to review hospital medical records, the cardiothoracic surgical database and neurological database at Children's Healthcare of Atlanta to assess their clinical and functional outcomes. We will review surgery information, clinic visits to Sibley Heart Center Cardiology, and echo, MRI and neurological testing results as well as mortality for these patients. No patient will be contacted. This retrospective study is important as a follow-up to the initial prospective pilot study as it will provide information regarding the clinical outcome of the patients.

Eligibility criteria: Inclusion Criteria:

* participated in previous 621-2004 blood marker study for infants and children having open-heart surgery with cardiopulmonary bypass with or without hypothermic circulatory arrest

Exclusion Criteria:

* Those who do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Janet M Simsic, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03436186: Swallowing and Voice Outcomes After Thyroidectomy
Official title: Objective Analysis of Swallowing and Functional Voice Outcomes After Thyroidectomy: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Voice and Swallowing Outcomes
Keywords: Thyroidectomy
voice
swallowing problems
dysphagia
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 43
Sex: ALL
Minimum age (years): 27
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who underwent thyroidectomy without recurren nerve injury

Brief summary: Impairment in voice and swallowing functions are common after thyroidectomy. The investigators aimed to evaluate the objective functional voice and swallowing outcomes in a series of patients undergoing thyroidectomy.

according to the study, even in the absence of recurrent laryngeal nerve injury, subjective and objective swallowing and voice alterations do occur after thyroidectomy.

Detailed description: A total of 43 consenting patients who underwent thyroidectomy were prospectively recruited. Subjective evaluation of swallowing was assessed with 'Swallowing Impairment Score' and 'MD Anderson Dysphagia Inventory'. Fiberoptic endoscopic evaluation of swallowing (FEES) was applied for objective evaluation. Also, functional oral intake scale (FOIS) and functional outcome swallowing scale (FOSS) were used for swallowing assessment. Voice evaluation was assessed with videostrobolaryngoscopy (VSL) and 'The Multi-Dimensional Voice Program (MDVP)' was used for capturing and analyzing the voice samples. All evaluations were performed preoperatively and on 1st day, 2nd week and 6th months postoperatively.

Eligibility criteria: Inclusion Criteria:

* patients undergoing thyroidectomy

Exclusion Criteria:

* Patients who were diagnosed with thyroid carcinoma preoperatively
* Having history of previous neck surgery,
* History of radiotherapy at head and neck region,
* Vocal cord paralysis,
* neuromuscular dysfunction,
* larynx, esophagus and chest pathology
* who did not want to be involved in the study

Primary outcomes:
measure: the intake of fluid and thickened liquid food
timeFrame: 6 months
measure: light and moderate residual accumulation in solid food intake
timeFrame: 6 months
measure: functional oral intake score
timeFrame: 6 months
measure: voice evaluation
timeFrame: 6 months
measure: Swallowing impairment score (SIS)
timeFrame: 6 months
measure: MD Anderson dysphagia inventory (MDADI)
timeFrame: 6 months
Secondary outcomes:
measure: objective and subjective values correlation
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Gumus T, Makay O, Eyigor S, Ozturk K, Erdogan Cetin Z, Sezgin B, Kolcak Z, Icoz G, Akyildiz M. Objective analysis of swallowing and functional voice outcomes after thyroidectomy: A prospective cohort study. Asian J Surg. 2020 Jan;43(1):116-123. doi: 10.1016/j.asjsur.2019.04.013. Epub 2019 May 23.
Clinical trial NCT03102086: The Association Between Nephrolithiasis and Periodontal Status
Official title: The Association Between Nephrolithiasis and Periodontal Status
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periodontal Diseases
Nephrolithiasis
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-04-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients diagnosed with kidney stone.

Brief summary: Dental calculus is a calcified deposits firmly attached to teeth and implants surfaces. Dental calculus is strongly associated with periodontitis and considered to have indirect role in the pathogenesis of periodontal diseases. Dental calculus composed primarily of calcium phosphate mineral salts originated in the saliva covered by unmineralized bacterial layer. Composition of calculus varies from person to person and influenced by numerous variables such as: age, gender systemic disease and ethnic background.

Nephrolithiasis (kidney stones) are composed of insoluble salts of constituents of the forming urine. The most two frequent stone types are: Calcium oxalate (with a frequency of 15% -35%) and Calcium phosphate (5% -20%). The prevalence of kidney stones varies with race, sex, and geographic location. In the United States for men, kidney stone rates vary between 4%-9%, and for women, kidney stone rates range between 2%-4%.

Previous studies dealt with the connection between sialolithiasis and nephrolithiasis were inconclusive. To the authors' best knowledge no studies were done to examine the associations between nephrolithiasis and dental calculus. Thus, the aim of this study is to compare the mineral composition of both dental calculus and nephrolithiasis and determine whether nephrolithiasis composition may be linked to the periodontal status.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with nephrolithiasis
* Over 18 years old

Exclusion Criteria:

* Pregnant woman, uncontrolled diabetes (HbA1c \> 7.5%), patients who received periodontal treatment in the past 6 months, smokers

Primary outcomes:
measure: the composition of both specimens
timeFrame: the analysis will take 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus, Dept. of Periodontology
Study officials:
References: