louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02808169: Radlink GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
Official title: Radlinik GPS Provide a Valid Intra-operative Assessment of Acetabular Inclination and Anteversion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implant Position in Total Hip Replacement
Lead sponsor: Barrett, William, M.D.
Sponsor class: INDIV
Collaborators: name: DePuy Synthes
First posted: 2016-06-21
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient under going total hip replacement

Brief summary: Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.

Detailed description: Evaluate the accuracy of Radlink System in determining acetabular cup placement and limb length evaluation during Anterior hip replacement as measured intraoperative with C-Arm visualization and confirmed with digital x-ray at 4-6 weeks postoperatively.

GPS may improve total hip replacement by allowing surgeons to measure the exact position of components placed during surgery and there is a question whether RADLINK helps surgeons place the acetabular cup (the part that goes into the hip bone) component in a precise position. The objective of the study is to determine whether GPS gives surgeons reliable, valid information about the orientation of the cup component. The surgeons need to collect data to help clarify this issue.

Eligibility criteria: Inclusion Criteria:

* Both: both female and male participants are being studied.
* Minimum Age: Age of participants is between 20 years - 75 years.
* Accepts: Persons who are in need of a total hip replacement

Exclusion Critieria:

* Has an existing condition that would compromise participation
* Had previous surgery on affected hip

Primary outcomes:
measure: Comparison of intra-op values for acetabular inclination and ante version, limb length using Radlink with those obtained and 4-8 weeks postop digital films.
timeFrame: 4-8 weeks
Secondary outcomes:
measure: Accuracy of cup placement/limb length with Radlink to a predetermined value and what surgeon obtains with Radlink guidance.
timeFrame: 4-8 weeks
Other outcomes:
Locations:
city: Renton
country: United States
facility: VOA Research Foundation
state: Washington
Study officials:
affiliation: VOA Research Foundation
name: William Barrett, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02492269: Stress Response and Neurodevelopmental Outcome After Cardiac Surgery Utilizing CPB in Children: A Prospective, Double Blinded and Randomized Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Congenital Heart Disease
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.


Eligibility criteria: Inclusion Criteria:

* Patients with the following diagnosis:

  1. ASD
  2. VSD
  3. AVSD
  4. TOF
  5. Biventricular repair with left to right shunt.

Exclusion Criteria:

* Patients with the diagnosis of AVSD and pulmonary hypertension
* Patients less than 1 year and require any of the following repairs:

  1. HLHS
  2. Aortic arch reconstruction
  3. Arterial switch
  4. TOF with pulmonary atresia

Primary outcomes:
measure: Change in cytokine levels
timeFrame: From baseline to 24 hrs post-op
measure: Change in hormone levels
timeFrame: From baseline to 24 hrs post-op
measure: Change in neurodevelopmental scores
timeFrame: From baseline to 1 year post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
Clinical trial NCT03020069: Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
Official title: Use of Continuous Glucose Monitoring System With Intensive Feedback in Adolescents With Poorly Controlled Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Adolescents
Glucose Monitoring
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine that continuous glucose monitoring systems (CGMS) with intensive real time feedback about diabetes management from medical staff to the patient will affect motivation and/or behavior, in adolescents with poorly controlled type 1 diabetes. The investigators hypothesize that short-term CGMS use with feedback (and/or lack thereof) and patients' sense of self-efficacy will influence their stage of change and potentially glucose levels.

Detailed description: Sixty adolescents, ages 13-19 years, with type 1 diabetes and an HbA1c \> = 8 % who are also naive to CGMS use will be recruited from the diabetes outpatient population followed at Bellevue Hospital, Lutheran Hospital, Woodhull Hospital, and the NYU Fink Pediatric Ambulatory Care Center. Forty subjects will be randomly assigned to the CGMS group and 20 subjects will be assigned to the control group.

Eligibility criteria: Inclusion Criteria:

* type 1 diabetes
* HbA1c \> = 8 %
* naive to CGMS use

Exclusion Criteria:

* Patients with developmental delay
* Patients who do not use a glucose meter to test capillary blood glucose level
* Patients without access to a telephone will be excluded.

Primary outcomes:
measure: Change in Score of Pediatric Quality of Life Inventory 3.2 Diabetes Module (Peds QL 3.2) From Baseline to 3 Months
timeFrame: Baseline, 3 Months
measure: Change in Glycated Hemoglobin (HbA1c) Levels From Baseline to 3 Months
timeFrame: Baseline, 3 Months
measure: Change in Level of Blood Sugar (Glucose) From Baseline to 3 Months
timeFrame: Baseline, 3 Months
measure: Change in Score of Diabetes Empowerment Scale Short Form (DES-SF) From Baseline to 3 Months
timeFrame: Baseline, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Medical Center
state: New York
Study officials:
affiliation: NYU School of Medicine
name: Bonita Franklin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06322069: The Effect and Mechanism of Self-compassion on Reducing Materialism
Official title: The Effect and Mechanism of Self-compassion on Reducing Materialism: A Randomized Controlled Trial of an Online Self-Compassion Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-Compassion
Group B
Keywords: self-compassion
materialism
self-esteem
basic psychological needs
self-help intervention
loving-kindness meditation
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 309
Sex: ALL
Minimum age (years): 18
Maximum age (years): 63
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In study 2, we conducted a randomized control trial, and there are two groups: self-compassion intervention group and waitlist group.
Primary purpose: OTHER

Brief summary: The current study provided an initial investigation of the effect of self-compassion on reducing materialism and explored the basic psychological needs and self-esteem as potential mechanisms. Two studies would be conducted. Study 1 explored the relationships among variables with cross-sectional data, to explore the relationship between self-compassion and materialism, and test the mediating role of basic psychological needs and self-esteem. Study 2 developed a new online self-help self-compassion intervention and conducted a randomized control trial (i.e., intervention group and waitlist group) to further explore the casual effect of self-compassion on materialism, with the mediating effect of basic psychological needs and self-esteem.

Detailed description: The inclusion criteria were as follows: (1) consented to accept randomization, finish the intervention and fill out questionnaires and (2) had no current or previous mental disorder diagnosis.

The Chinese Version of Self-compassion Scale (SCS-C; Chen et al., 2011) was used to measure the self-compassion level of participants. The Rosenberg Self-Esteem Scale (RSES; Rosenberg, 1965) was used to measure self-esteem using 10 items. The Balanced Measure of Psychological Needs Scale (BMPN; Sheldon \& Hilpert, 2012) was used to measure basic psychological needs. The Material Tendencies Scale (MTS; Zhang \& Xiao, 2019) was used to measure materialism.

Eligibility criteria: Inclusion Criteria:

1. consented to accept randomization, finish the intervention and fill out questionnaires and
2. had no current or previous mental disorder diagnosis.

Exclusion Criteria:

1. did not accept randomization, can not finish the intervention and fill out questionnaires
2. had current or previous mental disorder diagnosis.

Primary outcomes:
measure: Self-compassion
timeFrame: 12 weeks
measure: Self-Esteem
timeFrame: 12 weeks
measure: Basic Psychological Needs
timeFrame: 12 weeks
measure: Materialism
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xianglong Zeng
state: Beijing
Study officials:
References:
Clinical trial NCT03654469: Bronchial Obstruction in Dairy Farmers
Official title: Bronchial Obstruction in Dairy Farmers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 1247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
* control: non farmer

Brief summary: Chronic Obstructive Pulmonary Disease (COPD) is a major public health problem and is expected to become the 3rd leading cause of death globally by 2020.

The main risk factor is tobacco. Tobacco poisoning is found in 80 to 90% of patients with COPD. However, non-smoking COPD is also described, with increasing prevalence figures, particularly related to occupational exposure, especially among farmers.

Detailed description: A prospective screening study based on questionnaires and electronic mini-spirometry (Néo-6®) that includes a representative sample of dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany.

The dairy farmers had an occupational medicine appointment and, if they demonstrated at least one marker of possible bronchial obstruction (chronic cough, chronic bronchitis, dyspnoea, wheezing, spirometry), they were referred to a pulmonologist.

Eligibility criteria: Inclusion Criteria:

* dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
* control: non farmer

Exclusion Criteria:

* pigs or grain farmers
* Pregnant women
* oral corticosteroids or immunosuppressive drugs

Primary outcomes:
measure: Level of bronchial obstruction
timeFrame: 3 years
Secondary outcomes:
measure: Prevalence of occupational specific COPD in dairy farmers
timeFrame: 3 years
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital - Service de Pneumologie
Study officials:
affiliation: Rennes University Hospital
name: Stéphane Jouneau, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Jouneau S, Chapron A, Ropars C, Marette S, Robert AM, Gouyet T, Belleguic C, Rochefort-Morel C, Guillot S, Mailloux C, Desrues B, Viel JF; AIRBAg research group. Prevalence and risk factors of asthma in dairy farmers: Ancillary analysis of AIRBAg. Environ Res. 2022 Nov;214(Pt 4):114145. doi: 10.1016/j.envres.2022.114145. Epub 2022 Aug 20.
Clinical trial NCT06179368: Throid Dysfunction in Liver Failure and Its Eddects Upon Outcome
Official title: Thyoid Dysfucntion; Does it Affect the Short Term Outcome of Heptic Failure Patiens ?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatic Encephalopathy
Hepatic Impairment
Hypothyroidism
Hepatic Failure
Keywords: Hepatic Failure
Hypothyroidism
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all hepatic failutre patients who will be admitted to ICU will be enrolled, and throid function will be assessed. Groupingwil be done based upon throid function

Brief summary: Liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to triiodothyronine (T3) by Type 1 deiodinase.

Detailed description: In clinical terms, cirrhosis is described as are either "compensated" or "decompensated." Decompensation means cirrhosis complicated by one or more of the following features: jaundice, ascites, hepatic encephalopathy (HE), or bleeding varices. Ascites is the usual first sign. Hepatorenal syndrome, hyponatremia, and spontaneous bacterial peritonitis are also features of decompensation, but in these patients, ascites invariably occurs first. Compensated cirrhotic patients have none of these features.

The liver plays an important role in the metabolism of thyroid hormones, as it is the most important organ in the peripheral conversion of tetraiodothyronine (T4) to T3 by Type 1 deiodinase.

T4 and T3 regulate the basal metabolic rate of all cells, including hepatocytes, and thereby modulate hepatic function. The liver metabolizes the THS and regulates their systemic endocrine effects. Thyroid diseases may perturb liver function; liver disease modulates thyroid hormone metabolism; and a variety of systemic diseases affect both the organs.

Eligibility criteria: Inclusion Criteria:

- hepatic fauiure patients

Exclusion Criteria:

* hypethyroid patients

Primary outcomes:
measure: short termoutcome
timeFrame: (0 to 30 days)
Secondary outcomes:
measure: complications
timeFrame: (0 to 30 days)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
citation: Punekar P, Sharma AK, Jain A. A Study of Thyroid Dysfunction in Cirrhosis of Liver and Correlation with Severity of Liver Disease. Indian J Endocrinol Metab. 2018 Sep-Oct;22(5):645-650. doi: 10.4103/ijem.IJEM_25_18.
citation: McCormick PA. Sherlock's Diseases of the Liver and Biliary System Textbook. Hepatic Cirrhosis. In: Dooley JS, Lok AS, Burroughs AK, Heathcote EJ, editors. 12th ed. Ch. 7. UK: Wiley-Blackwell, A John Wiley and Sons, Ltd; 2011. pp. 103-8.
Clinical trial NCT01371968: Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia
Official title: Optimal Dose of Alfentanil for Removal of Supreme Laryngeal Mask Airway During Emergence From Desflurane Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Response
Keywords: Alfentanil
optimal dose
laryngeal mask airway
Lead sponsor: University of Malaya
Sponsor class: OTHER
Collaborators: name: Malaysian Society of Anaesthesiologists
First posted: 2011-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to determine the optimal dose of alfentanil in suppressing the airway reflexes during supreme LMA removal in anaesthetized adult.

Detailed description: The removal of LMA may be associated with coughing, biting, agitation and airway complication such as laryngospasm. Thus it is advisable to remove the LMA when the patient is breathing spontaneously and when the airway reflexes are still depressed. A number of techniques have been used to prevent this adverse emergence phenomenon, such as removing the tube while the patient is in deep plane of anaesthesia or administration of local anaesthetic and intravenous opioids

The administration of intravenous opioids before emergence may be useful for preventing cough, agitation and hemodynamic response. Alfentanyl is proven to suppress cough and agitation during the endotracheal tube emergence. However, its use in suppressing cough in LMA patient has not been evaluated.

Eligibility criteria: Inclusion Criteria:

1. ASA I and II patients
2. Age 18 to 49 years old
3. Minor elective day care surgery (\> 20 minute and less than 2 hours) which require local anaesthetic infiltration and does not require use of long acting opioids.

Exclusion Criteria:

1. Potential difficult airway
2. Reactive airway disease or sign and symptoms of upper respiratory tract infection.
3. History of cardiac, pulmonary and renal diseases
4. Body Mass Index \> 30 kgm2.
5. Risk of aspiration.
6. Poor dentition with high risk of damage.
7. Patient refusal.

Primary outcomes:
measure: Optimal dose of alfentanil for successful LMA removal in spontaneously breathing anaesthetized adults
timeFrame: 6 months
Secondary outcomes:
measure: Number of patient with airway complication
timeFrame: after administration of alfentanil and within 1 min of LMA removal
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
Study officials:
affiliation: Department of Anaesthesiogy, UMMC.
name: Lee Chew Kiok, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05582668: Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study
Official title: Sarcopenia After Bariatric Surgery in Older Patients: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Bariatric Surgery
Aging
Sarcopenic Obesity
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with overweight, obesity or after bariatric surgery

Brief summary: The retrospective cohort study will compare the prevalence of sarcopenia and associated factors between older patients who have undergone bariatric surgery and older patients with obesity without previous bariatric surgery.

Detailed description: The aim of the study is to compare the prevalence of sarcopenia and nutritional status between adults older than 65 years who have previously undergone bariatric surgery and patients with obesity but without previous bariatric surgery. Current sarcopenia will be assessed during a cross-sectional assessment after surgery using the criteria from the European Working Group on Sarcopenia in Older People (EWGSOP).

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Age 65 years or older
* Cohort 1 (exposed): Previous bariatric surgery for obesity at least 1 one year ago
* Cohort 2 (unexposed): No previous weight loss surgery

Exclusion Criteria:

* Current diagnosis of cancer
* Advanced organ failure, including chronic kidney disease Stage 5, liver cirrhosis Stage 3, intestinal failure, heart failure stage D, or chronic obstructive pulmonary disease stage 4.
* Immobility
* Neuromuscular degenerative conditions

Primary outcomes:
measure: The number of older patients with sarcopenia after bariatric surgery compared to non-surgical control patients.
timeFrame: At least one year post surgery
Secondary outcomes:
measure: 1. Appendicular skeletal muscle mass older of patients after bariatric surgery compared to non-surgical control patients
timeFrame: At least one year post surgery
measure: 2. The prevalence of nutrient deficiencies in older patients after bariatric surgery compared to non-surgical control patients.
timeFrame: At least one year post surgery
measure: 3. Markers of chronic systemic inflammation in older patients after bariatric surgery compared to non-surgical control patients
timeFrame: At least one year post surgery
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Obesity Clinic University Hospitals Leuven
Study officials:
References: