louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05016128: Intraoperative S-ketamine to Prevent Postoperative Hyperalgesia in Patients Undergoing Video-assisted Thoracic Surgery
Official title: Second Affiliated Hospital Zhejiang University School of Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Hyperalgesia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative hyperalgesia (POH) is a paradoxical clinical state of increased sensation of pain or increased sensitivity to non-painful stimuli at the site of surgery or at a surrounding area that was not directly injured. Opioid-induced hyperalgesia (OIH) and nociceptive-induced hyperalgesia (NIH) are the two main causes of POH.N-methyl-D-aspartate receptor (NMDAR) activation plays a central role in the development of POH.S-ketamine，which is a NMDA-receptor antagonist,has been on the market in china since 2019.The aim of this study is to evaluate the effects of S-ketamine on POH and chronic postoperative pain after video-assisted thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status class I-III.
* elective single-port video-assisted thoracic surgery under general

Exclusion Criteria:

* a history of thoracic surgery
* a history of chronic pain
* ongoing pain treatment
* opioid drug or alcohol abuse
* a history of allergy to anesthetics
* obesity (body mass index \[BMI\] \>30 kg/m2 )
* pregnancy
* psychiatric disorders
* neurological disease
* severe diabetes
* renal or hepatic insufficiency
* uncontrolled hypertension, or arrhythmia

Primary outcomes:
measure: the mechanical pain threshold around the incision
timeFrame: Day1 after surgery
Secondary outcomes:
measure: the mechanical pain threshold on the forearm
timeFrame: the day before surgery
measure: the mechanical pain threshold
timeFrame: Day1 after surgery
measure: the mechanical pain threshold
timeFrame: Day2 after surgery
measure: the mechanical pain threshold around the incision
timeFrame: Day2 after surgery
measure: postoperative pain scores
timeFrame: up to day2 after surgery
measure: Anxiety scale scores
timeFrame: up to day2 after surgery
measure: Depression scale scores
timeFrame: up to day2 after surgery
measure: The hyperalgesic area around the incision
timeFrame: up to day2 after surgery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated Hospital School of Medicine,Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02625428: IRB 14-009240, Does CEUS Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?
Official title: Does Contrast-Enhanced Ultrasound Positively Influence Selection of Biopsy Sites When Evaluating Transplant Kidneys?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Transplantation, Kidney
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This is a pilot study to investigate whether contrast-enhanced ultrasound (CEUS) may help evaluate segmental differences in renal perfusion better than Doppler Ultrasound and thus help direct the biopsy to the most abnormal part of the renal cortex. This should maximize detection and increase the odds of demonstrating the true grade/severity of the histopathological abnormality.


Eligibility criteria: Inclusion

* Ability to provide informed consent
* Male and female \>18 years
* Patients undergoing renal transplant ultrasound-guided percutaneous biopsy within 24 months post transplant including patients undergoing biopsy to evaluate a recent rise in serum creatinine so called for cause biopsies and patients undergoing routine protocol (surveillance) biopsies without other evident of renal dysfunction

Exclusion:

* Pregnant women or women who are nursing an infant are not able to participate in this study
* Known patent forearm ovale (PFO)
* Significant heart disease

Primary outcomes:
measure: Abnormal Biopsy
timeFrame: 1 year
Secondary outcomes:
measure: Number of Patients With a Higher Degree of Renal Transplant Rejection Using Multiple Biopsies Compared to a Single Biopsy.
timeFrame: 1 year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: J Kriegshauser, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05378828: Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors for Elderly People in EHPAD
Official title: Interest of Using an Electric Wheelchair Equipped With Anti-collision Sensors to Improve the Driving Confidence of Elderly People in EHPAD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Elderly
Lead sponsor: Pôle Saint Hélier
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Saint Etienne
name: Centre Communal d'Action Sociale Saint-Etienne
First posted: 2022-05-18
Enrollment: 1
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The device which is the subject of this investigation is a robotic assistance module for the driving of a semi-autonomous electric wheelchair (FRE). It's intended to accessorize the FRE to improve the safety conditions during the driving of a FRE, making it possible to decrease the rate of accident in wheelchair on the one hand, increase the confidence of driving on the other hand, and facilitate the access to the FRE of people not being able to aspire to it without the use of a device of safety of this type.


Eligibility criteria: Inclusion Criteria:

* Over 60 years of age,
* Resident in an institution for the elderly or nursing home,
* with a electric wheelchair but expressing driving difficulties
* Having freely consented to participate in the study,
* In the case of a guardianship, the legal representative having read the information document intended for the legal guardian of an adult under legal protection (under guardianship) and having given his or her free and informed consent for the person for whom he or she is responsible to participate in the study (in agreement with the patient).

Exclusion Criteria:

* Impaired comprehension preventing the protocol from being carried out,
* Person in an emergency situation unable to give prior consent

Primary outcomes:
measure: Evaluate benefits of using a FRE equipped with the assistance module on the confidence in driving electric wheelchair for elderly people in EHPAD
timeFrame: Day 42
Secondary outcomes:
measure: Driving habilities
timeFrame: Day 42 and Day 63
measure: Distance traveled measured by sensors on the FRE
timeFrame: Day 21, Day 42 and Day 63
measure: Mesure of mental load related to wheelchair mobility
timeFrame: Day 21, Day 42 and Day 63
measure: Ease of Use Questionnaire
timeFrame: Day 42
measure: Acceptability of anti-collision sensors by users
timeFrame: Day 42
Other outcomes:
Locations:
city: Rennes
country: France
facility: Pôle Saint-Hélier
state: Bretagne
city: Saint Etienne
country: France
facility: CCAS Saint-Etienne
city: Saint-Étienne
country: France
facility: USLD Saint Etienne
Study officials:
References:
Clinical trial NCT02854228: PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon
Official title: PITUItary Carcinomas or Aggressive Tumors REgistry: Monocentric Study Form a Cohort of Patient Operated on for Pituitary Tumors in University Hospital of Lyon (France)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pituitary Tumor
Keywords: Pituitary tumor
pituitary carcinoma
acromegaly
cushing
prolactinoma
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 1300
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: tertiary referral center

Brief summary: The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.


Eligibility criteria: Inclusion Criteria:

• patients with confirmed pituitary disease

Exclusion Criteria:

• patients who do not have confirmed pituitary disease

Primary outcomes:
measure: Progression free survival after pituitary surgery according to the clinicopathological classification (HYPOPRONOS)
timeFrame: up to 10 years (postoperatively)
Secondary outcomes:
measure: Correlation between percentage of SSTR expression of the pituitary tumor and somatostatine analogs efficacy.
timeFrame: 2007-2020
measure: Correlation between percentage of MGMT expression of the pituitary tumor and tumor response to temozolomide.
timeFrame: 2007-2020
Other outcomes:
Locations:
city: Bron
country: France
facility: Groupement Hospitalier Est, Lyon, France
Study officials:
affiliation: Hospices Civils de Lyon
name: Gerald Raverot, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raverot G, Dantony E, Beauvy J, Vasiljevic A, Mikolasek S, Borson-Chazot F, Jouanneau E, Roy P, Trouillas J. Risk of Recurrence in Pituitary Neuroendocrine Tumors: A Prospective Study Using a Five-Tiered Classification. J Clin Endocrinol Metab. 2017 Sep 1;102(9):3368-3374. doi: 10.1210/jc.2017-00773.
Clinical trial NCT02689128: Postoperative Nausea and Vomiting: to Estimate the Incidence and Risk Factors in a Tertiary Teaching Hospital
Official title: Postoperative Nausea and Vomiting: A Prospective Observational Study to Estimate the Incidence and Risk Factors Over One Year in a Tertiary Teaching Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Nausea and Vomiting
Keywords: Anesthesia
postoperative
nausea
vomiting
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 6000
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: Patients who undergoes anesthesia and surgery and suffer from postoperative nausea and vomiting for 24 hours

Brief summary: Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia.

The aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Detailed description: Postoperative nausea and vomiting (PONV) is a frequent complication of surgery and anesthesia, in the literature it reaches up to 70% of the surgical patients and it occurs after local and general anesthesia with surgery.

Locally in Jordan there was no proper clinical study to estimate PONV among surgical patients, the aim of this study is to estimate the incidence and the risk factors of PONV at Jordan University Hospital over one year period.

Eligibility criteria: Inclusion Criteria:

* Patients who undergoes anesthesia and surgery.
* Patients who suffer from postoperative nausea and vomiting for 24 hours.

Exclusion Criteria:

* Patients who suffer from postoperative nausea and vomiting after 24 hours.
* Patients who undergoes Day-case surgery.

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: University of Jordan
Study officials:
affiliation: University of Jordan
name: Subhi M Alghanem, FFARCS
role: STUDY_CHAIR
References:
citation: Hambridge K. Assessing the risk of post-operative nausea and vomiting. Nurs Stand. 2013 Jan 2-8;27(18):35-43. doi: 10.7748/ns2013.01.27.18.35.c9486.
Clinical trial NCT03200028: CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
Official title: CCTAP: Cognitive Control Training for Treatment of AUD-PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Post Traumatic Stress Disorder
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: VA Palo Alto Health Care System
First posted: 2017-06-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the feasibility of the revised brain training program with individuals diagnosed with Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).


Eligibility criteria: Inclusion Criteria:

* Participant is a Veteran and is enrolled in outpatient Substance Use Disorder treatment within Veteran Affairs Palo Alto Health Care System
* Participant meets Diagnostic and Statistical Manual of Mental Disorders-5 criteria for current Alcohol Use Disorder and seeking treatment for Alcohol Use Disorder
* Participant meets Meet Diagnostic and Statistical Manual of Mental Disorders-5 criteria for current PTSD
* Participant must be willing to perform daily home-based computer exercises for 6 weeks
* Participant must demonstrate mild cognitive deficit on neuropsychological tests at the screening visit
* Participant must be a fluent English speaker from the age of 12
* Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a iPad screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a touchpad

Exclusion Criteria:

* Participant with diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis, Traumatic Brain Injury, mental retardation or pervasive developmental disorder, epilepsy, Parkinson's Disease, delirium or dementia)
* Participant with active suicidal ideations as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
* Participant with problems performing assessments or comprehending or following spoken instructions
* Participant who has been treated within 5 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science
* Participant with current severe traumatic brain injury
* Participant with any type of dementia
* Participant with any type of mental retardation
* Participant with limited ability to speak/read/write/understand English

Primary outcomes:
measure: Acceptability
timeFrame: At 6 weeks
measure: Usability
timeFrame: At 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Veterans Affairs Palo Alto Health Care System
state: California
Study officials:
affiliation: Posit Science Corporation
name: Hyun Kyu Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05416528: Chinese Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8)
Official title: Translation and Validation of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) Among Chinese Soft Contact Lens Wearers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contact Lens
Questionnaire
Contact Lens Discomfort
Keywords: the 8-item Contact Lens Dry Eye Questionnaire
CLDEQ-8
Contact Lens Discomfort
Questionnaire
Chinese translation and validation
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-06-13
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects are residents of Guangzhou, China.

Brief summary: This is a cross-cultural adaptation, evaluation and validation study of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among soft contact lens wearers in China.

Detailed description: The aim of this study is to translate the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) into Chinese and evaluate its validity, and reliability among soft contact lens wearers in China. One hundred and thirty-four Chinese soft contact lens wearers will be included in the study. Subjects are required to complete the Chinese version of the 8-item Contact Lens Dry Eye Questionnaire (C-CLDEQ-8) on paper before eye examinations. A subgroup of 50 participants will be asked to complete C-CLDEQ-8 twice to evaluate the repeatability.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-60
2. Native Chinese citizens with Chinese as first language
3. Wearing history with spherical disposable SCL (daily disposable, 2 weeks, or monthly disposable) for a least 1 months;
4. Willing to sign informed consent

Exclusion Criteria:

1. Any extended wear of SCLs, including wearing toric or multi-focal SCLs
2. Use SCL for monovision correction
3. Having clinically significant anterior segment abnormalities (including iritis and infection of the eye, lids, or ocular adnexa)
4. Having ocular or systemic disease that would preclude SCL wearing
5. Best corrected visual acuity of less than 0.8 in either eye
6. History of refractive or other types of corneal surgeries
7. Having eyelid abnormalities or functional ocular disorders that would induce relevant discomfort.

8) Having congenital or systemic conditions that would limit the capacity to answer the questionnaire

Primary outcomes:
measure: The reliability of the C-CLDEQ-8
timeFrame: before the ocular examination
Secondary outcomes:
measure: The repeatability of the C-CLDEQ-8
timeFrame: before and after the ocular examination on the same day of visit
measure: Cutoff score for C-CLDEQ-8 to predict "Excellent/Very Good" overall of SCLs.
timeFrame: before the ocular examination
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06317428: NT-proBNP Levels During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.
Official title: Change in Serum Levels of NT-proBNP During Triple Therapy With Formoterol/Glycopyrrolate/Budesonide in Patients With COPD.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Keywords: COPD
Formoterol
glycopyrrolate
budesonide
NT-pro-BNP
Lead sponsor: Istituto Nazionale di Ricovero e Cura per Anziani
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with COPD with clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide;

Brief summary: Observational prospective study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the iniation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.

Detailed description: The purpose of the trixeo study is to conduct a prospective observational study to evaluate serum NT-proBNP levels in a population of COPD patients three months after the initiation of triple inhaled formoterol/glycopyrrolate/budesonide therapy.

Eligibility criteria: Inclusion Criteria:

* COPD;
* Clinical indication for triple inhalation therapy with formoterol/glycopyrrolate/budesonide;

Exclusion Criteria:

* Life expectancy less than one year;

Primary outcomes:
measure: Change in serum NT-pro-BNP levels
timeFrame: Before and 3 months after the start of triple therapy with formoterol/glycopyrrolate/budesonide
Secondary outcomes:
Other outcomes:
Locations:
city: Ancona
country: Italy
facility: INRCA Hospital
city: Osimo
country: Italy
facility: IRCCS INRCA Hospital
Study officials:
affiliation: IRCCS INRCA, Ancona, Italy
name: Francesco Spannella
role: STUDY_CHAIR
References:
Clinical trial NCT01797328: Does Cold Provocation Increase Brown Adipose Tissue Volume?
Official title: Study of the Effects of Temperature on Amount of Brown Adipose Tissue in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brown Adipose Tissue, Human
Keywords: brown adipose tissue, human
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: About 28 healthy subjects are randomized to 1 hour/day of coldprovocation or to the best of ability to avoid feeling cold, for 6 weeks. Basal metabolic rate and magnetic resonance (for determination of brown adipose tissue volume) imaging are performed before and after the study.


Eligibility criteria: Inclusion Criteria: healthy subjects -

Exclusion Criteria: any significant disease, ot other conditions that interferes with magnetic resonance imaging

-

Primary outcomes:
measure: Brown Adipose Tissue, Absolute Volume
timeFrame: Baseline and 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Faculty of Health Science, Linköping
Study officials:
References:
Clinical trial NCT04984928: Readmission Risk of Patients With Heart Failure.
Official title: Predicting the Risk of Readmission in Patients With Chronic Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Heart Failure
Keywords: Heart failure
Prediction
Personnalized medicine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart failure patients

Brief summary: Heart failure (HF) is a frequent, serious, and costly chronic disease: it leads to 150,000 hospitalizations each year in France at a cost of 525 million Euros.

It is estimated that 20-40% of these hospitalizations are preventable by known interventions: home telemonitoring, care coordination, therapeutic intensification and therapeutic education. But these interventions only work if patients at high risk of rehospitalization are targeted to individualize management. In these patients, the risk of rehospitalization depends on clinical, biological, socioeconomic, care pathway, and location-related data. Existing predictive tools perform poorly due to three important limitations: non-use of unstructured clinical data, lack of integration of multimodal data, and weakness of the algorithmic approach.

The objective is to design and validate a predictive algorithm for the risk of rehospitalization in heart failure patients, using multiple data sources


Eligibility criteria: Inclusion criteria:

* All consecutive adults
* Admitted to Montpellier University Hospital in 2017-2020
* For heart failure

Exclusion criteria:

- age \< 18 years

Primary outcomes:
measure: 30 days all cause readmission rate
timeFrame: day 30
Secondary outcomes:
measure: 90 days all cause readmission rate
timeFrame: day 90
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Grégoire Mercier, PU PH
role: PRINCIPAL_INVESTIGATOR
References: