louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03412422: Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart
Official title: Ultrasound Assessment of Changes in the Diameter of the Common Carotid Artery After Increasing the Preload of the Heart With Passive Leg Raise and Intravenous Fluid Infusion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Critical Illness
Fluid Responsiveness
Keywords: Passive Leg Raise
Fluid Challenge
Common carotid artery
Lead sponsor: Uniwersytecki Szpital Kliniczny w Opolu
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Mechanically ventilated patients admitted to critical care unit.

Brief summary: Passive leg raise (PLR) and fluid challenge are useful tools in assessing the fluid responsiveness. However, they require continuous monitoring of cardiac output, which is usually an invasive technique and in some cases not always available. Vascular ultrasound can be an alternative to cardiac output monitoring in a fluid status evaluation. The common carotid artery (CCA) is an easily accessible vessel. It has recently been noted that the diameter of this artery changes after an intravenous fluid bolus. It is possible that the change in the diameter of the common carotid artery during passive leg raise and fluid challenge can be a predictor of fluid responsiveness.


Eligibility criteria: Inclusion Criteria:

* mechanically ventilated patients with circulatory failure, who are monitored with PiCCO and need fluid responsiveness assessment

Exclusion Criteria:

* contraindication for the volume administration (hydrostatic pulmonary edema or other evidence of fluid overload)
* contraindication for PLR test (e.g. after trauma)
* lack of possibility to examine the carotid arteries
* bilateral carotid surgery in the past
* bilateral anatomical defects of the carotid arteries
* unstable cardiac rhythm (e.g. atrial fibrillation)

Primary outcomes:
measure: Changes in the diameter of the common carotid artery
timeFrame: 1 minute after PLR test and 1 minute after fluid challenge
Secondary outcomes:
measure: Evaluation the value of changes in the diameter of CCA as the predictor of fluid responsiveness.
timeFrame: 1 minute after PLR test and 1 minute after fluid challenge
Other outcomes:
Locations:
city: Opole
country: Poland
facility: Department of Anesthesiology and Intensive Care, Uniwersytecki Szpital Kliniczny w Opolu
state: Opolskie
Study officials:
References:
Clinical trial NCT03262922: Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment
Official title: Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Scleroderma
Keywords: systemic scleroderma
environmental and professional toxics
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 327
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with systemic scleroderma

Brief summary: The aim of the study is to compare the exposure to environmental and professional toxics by patients with systemic scleroderma and by patients not achieved by this pathology.

Detailed description: This study is based on a questionnaire.

The data will be collected according a retrospective and prospective design :

* at diagnostic of the disease
* at the inclusion in the systemic scleroderma cohort
* during the annual visit (in 2017-2018-2019-2020)

Eligibility criteria: Inclusion Criteria:

* Patients with systemic scleroderma

Exclusion Criteria:

-

Primary outcomes:
measure: Questionnaire to evaluate the exposition of environmental and professional toxics
timeFrame: once a year up to 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
affiliation: Rennes University Hospital
name: Patrick JEGO, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01453322: Video Documentation of Localized Complications
Official title: Video Documentation of Localized Complications in IV Cannulation Using Near-Infrared Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Access
Keywords: Veins
Vascular Access
IV complications
VeinViewer Vision
Lead sponsor: Christie Medical Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2011-10-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers

Brief summary: The objective of this study is to confirm and document that with the use of a FDA Class I exempt near infrared device, VeinViewer® Vision that is hands-free and can be used for healthy adult volunteers with varying skin types to assist in the improved visualization, it is possible to film, analyze and document PIV localized complications and venous flow and refill.


Eligibility criteria: Inclusion Criteria:

* Must be 18 years of age or older
* Must be considered in good health by investigator
* Must be able to read and understand English

Exclusion Criteria

* Less than 18 years of age
* Known allergy to Heparin
* History of HIT (Heparin-induced thrombocytopenia)
* Unable to read and understand English

Primary outcomes:
measure: Valve and Refill Confirmation
timeFrame: Immediately after flush-Day 1
Secondary outcomes:
measure: Video Documentation of localized vascular access complications
timeFrame: Immediately after attempt-Day 1
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Key Biologics LLC
state: Tennessee
Study officials:
affiliation: Key Biologics, LLC
name: Edward P Scott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04483622: Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients
Official title: Immunoglobulin G Antibody Immune Response Profile Following Infection With SARS-CoV-2 in COVID-19 Egyptian Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID19 IGg
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 33
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients attending sohag university hospital and have recent COVID -19 infection

Brief summary: The objective of this study is to detect the evidence on the immune response following acute SARS-CoV-2 infections. the study will report the profile of IgG specific antibodies levels to SARS-CoV-2 infection found in recovered coronavirus disease (COVID-19) patients after infection for both symptomatic and asymptomatic patients.

Detailed description: A total of 30 COVID-19 patients for the study will be enrolled. All the patients enrolled were confirmed to be infected with SARS-CoV-2 by RT-PCR assay for nasal and pharyngeal swab specimens.

For the study, serum samples of the 30 patients will be collected and will be investigated for the detection rate for immunoglobulin G (IgG). The first sample will be collected 2 weeks after the second negative RT-PCR assay for nasal and pharyngeal swab specimens and 6 samples will be collected after that for 6 months later; one serum sample tested every month for 6 months after.

The following questions will be addressed:-

1. What proportion of confirmed cases develops specific IgG antibodies to SARS-CoV-2?
2. How long is the duration of detection of serum IgG antibodies and antibody titres over time following infection with SARS-CoV-2?

Eligibility criteria: Inclusion Criteria:

* patients with recent COVID- 19 infection(2 weeks after the second negative RT-PCR assay)

Exclusion Criteria:

* patients on immune-suppressive therapy
* patients with immunological disease

Primary outcomes:
measure: rising titre of IGg antibodies
timeFrame: first month
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
Clinical trial NCT01561222: Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Kidney Disease Stage 1
Chronic Kidney Disease Stage 2
Keywords: calcitrol
Bone mineral density
Osteoprotegin
Vascular calcification
Lead sponsor: Taixing People's Hospital
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vitamin D Supplement in patients with CKD stage 1 and 2 may change osteoprotegin expression so as to produce beneficial effects of cardiovascular、bone metabolism and CKD progression.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of CKD stage 1 and 2
* Age \>18 years
* Ability to provide informed consent

Exclusion Criteria:

* On vitamin D in past 4 weeks
* Plans to relocate out of Taixing City in the next one year
* Serum phosphate \>5.5 mg/dl in past 3 months
* Serum calcium \>10.0 mg/dl in past 3 months
* Cancer
* Transplanted organ
* Rapidly deteriorating kidney function with the expectation for initiation of dialysis in less than 6 months

Primary outcomes:
measure: Osteoprotegin level
timeFrame: one year
Secondary outcomes:
measure: Bone mineral density
timeFrame: one year
measure: vascular calcification score
timeFrame: one year
Other outcomes:
Locations:
city: Taixing
country: China
facility: Taixing People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT02927522: Donepezil Attenuate Postoperative Cognitive Dysfunction
Official title: Donepezil Attenuate Postoperative Cognitive Dysfunction in Aged Patients- A Multi-center, Case Control, Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis
Femoral Head Necrosis
Rheumatoid Arthritis
Keywords: Postoperative Cognitive Dysfunction
Donepezil
Hip replacement
Knee replacement
Postoperative delirium
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
First posted: 2016-10-07
Enrollment: 550
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative cognitive dysfunction (POCD) occurs mainly in aged patients. POCD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to our previous study, the central cholinergic system impaired by the anesthesia and surgery play a very important role in the POCD and donepezil an acetylcholinesterase inhibitor can prevent the POCD after isoflurane anesthesia in aged mice. Donepezil is a commercial medicine used for the Alzheimer Disease, which is tolerable and has minimal adverse events. In present study a multi-center randomized case control study was conducted and we hypothesized that donepezil attenuate the POCD.


Eligibility criteria: Inclusion Criteria:

1. Elder than 60 years old
2. Speak Chinese Mandarin
3. Those who will undergo knee or hip replacement
4. Signed the inform consent
5. American Society of Anesthesiologists classification I to III

Exclusion Criteria:

1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;
2. existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;
3. several audition or vision disorder;
4. unwillingness to comply with the protocol or procedures.
5. Can not communicated with Chinese Mandarin
6. Existing bradycardiac arrhythmia（Heart rate \<60 bpm for any reasons）
7. Existing gastrointestinal ulcer
8. Existing urinary incontinence
9. Existing asthma or chronic obstructive pulmonary disease
10. Allegory to Donepezil

Primary outcomes:
measure: The incidence of POCD 7 days(or before leaving hospital ) after surgery
timeFrame: 7 days after surgery or before leaving hospital
measure: The incidence of postoperative delirium after surgery
timeFrame: 1 to 7 days after surgery
Secondary outcomes:
measure: POCD incidence 1 months after surgery
timeFrame: 1 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Diansan Su, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482022: Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
Official title: Speaking Valve Influence on Breathing, Swallowing and Vocal Functions in Patients With Tracheostomy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheostomy
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2022-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Speaking valve seems to have a beneficial influence on breathing and secretion management in certain patients with tracheostomy.

The investigators plan to use a speaking valve during respiratory physical therapy sessions in participants with disturbances of consciousness, who have a tracheostomy, with no need of a mechanical ventilation.


Eligibility criteria: Inclusion Criteria:

* brain injury (traumatic/non-traumatic).
* tracheostomy.
* unresponsive wakefulness syndrome or minimally conscious state.
* fiber optic examination as follows: good mobilization of the vocal cords. No airway granulation, MarianJoy scale score: 1-3.
* the legal guardian speaks Hebrew.

Exclusion Criteria:

* airway stenosis / inflammation.
* oxygen saturation \<90%.

Primary outcomes:
measure: change from baseline oxygen saturation
timeFrame: 15 minutes
measure: change from baseline breathing rate
timeFrame: 15 minutes
Secondary outcomes:
measure: rate of swallowing
timeFrame: 15 minutes
measure: percentage of participants presenting vocalization
timeFrame: 2 weeks
measure: cough rate
timeFrame: 2 weeks
measure: percentage of patients weaned from tracheostomy
timeFrame: through study completion, an average of 6 months.
Other outcomes:
measure: number of desaturation events
timeFrame: 2 weeks
measure: number of respiratory physical therapy sessions
timeFrame: 2 weeks
Locations:
city: Ra'anana
country: Israel
facility: Loewenstein Rehabilitation Hospital
Study officials:
References:
Clinical trial NCT04499222: Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes
Official title: Assessment of Tube Position According to the Changes of Neck Position Between Two Different Types of Nasotracheal Tubes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nasotracheal Intubation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to evaluate the appropriateness of the two kinds of nasotracheal tube (PORTEX POLAR \[Smiths Medical International, Hythe, United Kingdom\], Mallinckrodt TaperGuard \[Covidien, Ireland\]) depth in neutral, extended and flexed neck position when the upper border of the cuff of endotracheal tube is located 3cm below the vocal cords in neutral neck position.


Eligibility criteria: Inclusion Criteria:

1. Adult patients who undergoes elective surgery under general anesthesia with nasotracheal intubation

Exclusion Criteria:

1. Patients under 20 years old
2. Patients with ASA class IV or higher
3. Pregnant women
4. Patients receiving emergency surgery
5. Patients who have nasal disease or who undergo nose surgery because of nasal disease
6. Patient with craniofacial anomaly
7. Patients with impaired cervical motion
8. Patients who can not read the consent form or are not fluent in Korean (illiterate, foreigner)
9. Patients who refused the clinical trial Patients with dementia or cognitive impairment

Primary outcomes:
measure: The adequacy of nasotracheal tube tip location in neutral, extended and flexed neck position
timeFrame: 1 minute after nasotracheal intubation
Secondary outcomes:
measure: The adequacy of nasotracheal tube cuff location in extended and flexed neck position
timeFrame: 1 minute after nasotracheal intubation
measure: The adequacy of nasotracheal tube length
timeFrame: 1 minute after nasotracheal intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT05717322: TENS and Orthognathic Surgery
Official title: The Effect of Transcutaneous Stimulation (TENS) on the Recovery of Muscle Function After Orthognathic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthognathic Surgery
Keywords: orthognathic
TENS
EMG
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 34
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: All patients with skeletal deformity will undergo orthognathic surgery after orthodontic treatment. After surgery TENS electrodes( rubber electrodes with the same size 5.3×4.8 cm) will be Placed bilaterally on ant temporalis and bilaterally on superficial masseter muscle...Time : 30 min /3 times per week/ 6 weeks


Eligibility criteria: Inclusion Criteria:

* Class II facial deformity
* absence of temporomandibular joint pain and preoperative opening mouth limitation
* normal cranial form
* presence of dentition
* Fit to GA

Exclusion Criteria:

* temporomandibular joint pain and preoperative opening mouth limitation;
* craniofacial anomalies and abnormal cranial form
* absence of facial trauma, mandibular condylar fracture

Primary outcomes:
measure: maximum mouth opening
timeFrame: 6 months
Secondary outcomes:
measure: visual analogue scale
timeFrame: 6months
measure: muscle activity
timeFrame: 6months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT02818322: The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care
Official title: The Role of Telemedical Monitoring in Diabetic Foot Ulcer Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Foot - Telemedical Monitoring
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The role of telemedical monitoring in diabetic foot care is still uncertain. The aim is to compare telemedical + standard and standard alone outpatient monitoring in the care of patients with diabetic foot ulcers in a randomized controlled trial. The primary outcome of the overall study is the time of ulcer healing. The number of amputation, hospital admissions and surgical procedure will be also reported. Investigators hope to include 150 patients in this study.


Eligibility criteria: Inclusion Criteria:

* The patients treated in the diabetology department of CHU de Reims during the inclusion phase to a diabetic foot lesions ( infected or not).
* Patients with care of this lesion of diabetic foot externally.
* Patients who agreed to participate in or accepting ORNICARE network ( network for the transmission of information between health care professionals) (Appendix 3) .
* Patients aged over 18 years .
* Patients who agreed to participate in the study .
* The patients insured by a social security scheme .

Exclusion Criteria:

* Patients requiring hospital care of the lesion of diabetic foot (infection requiring surgical intervention , ischemia requiring revascularization , ...).
* Patients are protected by law .
* Minor patients.

Primary outcomes:
measure: time of ulcer healing
timeFrame: 6 month after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT01390922: Special Drug Use Investigation for Botox® (Botulinum) Spasticity (BOTOX is a Registered Trademark of Allergan, Inc.)
Official title: Special Drug Use Investigation for Botox® (Botulinum) Spasticity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mumps
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 1038
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese subjects with upper or lower limb spasticity who are treated with botulinum injection for the first time

Brief summary: The objective of this post-marketing surveillance study is to collect safety, efficacy and usage data on botulinum injection in subjects with upper or lower limb spasticity on the long-term use in clinical practice and to identify the factors affecting the safety or efficacy.


Eligibility criteria: Inclusion Criteria:

* Subjects with upper or lower limb spasticity
* Subjects must use botulinum injection for the first time

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: The number of adverse events in Japanese subjects with spasticity treated with botulinum injection
timeFrame: 1 year
measure: Occurence of adverse events at remote sites
timeFrame: 1 year
measure: Occurence of adverse events associated with pulmonary function
timeFrame: 1 year
measure: Onset status of adverse events associated with convulsion
timeFrame: 1 year
measure: Onset status of adverse events associated with accidents such as fall
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: