louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05776485: Protein Turnover in Healthy and Overuse-diseased Tendon
Official title: Protein Turnover in Healthy and Overuse-diseased Tendon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patella; Tendinitis
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to examine the regional protein turnover in tendon tissue from patients with chronic patellar tendinopathy and comparing this to healthy controls. Further we will examine the effect of resistance training on protein turnover in healthy individuals.


Eligibility criteria: Inclusion Criteria:

* Physical active men and women
* Body mass index 18,5 - 30 kg/m2

Inclusion Criteria for the chronic tendinopathy group:

* Debut of symptom \> 90 days prior to inclusion.
* Subjective activity related pain in patella tendon.
* Clinical symptoms of patella tendinopathy.
* Ultrasound verification of at least 1 in three of the following: Enchanced anterior-posterior diameter, increased Doppler signal and/or a hypoechoic area in the diseased part of the tendon.

Exclusion Criteria for all participants:

* Former knee surgery or injuries to the patella tendon.
* Local injection of corticosteroids within 12 months.
* Medication that affects protein synthesis in tendon tissue.
* Former/current use of anabolic steroids or growth hormone.
* Smoking
* Known rheumatoid disease or diabetes.
* Former participation in trials using deuterated water and 15N tracers.
* Treatment for patella tendinopathy within 3 months.

Primary outcomes:
measure: Protein turnover in tendon tissue from patients with chronic tendinopathy compared to healthy controls
timeFrame: 8 days
Secondary outcomes:
measure: Tracer incorporation in isolated fractions of the tendon
timeFrame: 8 days
measure: Tracer incorporation in isolated fractions of the tendon
timeFrame: 8 days
measure: Anterior-posterior dimensions of patella tendon
timeFrame: 8 days
measure: Doppler flow in patella tendon
timeFrame: 8 days
measure: Subjective pain in patella tendon
timeFrame: 8 days
measure: Subjective measure of physical activity and function
timeFrame: 1 day
measure: Single-leg decline squat test
timeFrame: 1 day
measure: One leg knee extension strength test
timeFrame: 8 days
measure: Leg press strength test
timeFrame: 8 days
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Institute of Sports Medicine Copenhagen
state: Capital Region
Study officials:
affiliation: Institute of Sports Medicine, Copenhagen
name: Michael Kjær, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02876185: Evaluation of the Possibility to Delegate Glaucoma Surveillance to Orthoptists in Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma surveillance
Orthoptist
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-08-23
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with an open-angle glaucoma or ocular hypertension

Brief summary: Glaucoma is a progressive optical neuropathy, generally associated with ocular hypertension. The treatment aims to stabilize the visual field deficiencies by lowering the intraocular pressure. Due to the fluctuation of the visual field test and re-test measures, the European recommendations are to obtain 6 visual field tests in 2 years (or one every 4 months) in order to know if the pathology is progressing despite the current treatment (or if the treatment is necessary, in cases of intraocular hypertensions). The lack of ophthalmologists renders the monitoring of a beginning glaucoma, rarely compatible with the present recommendations. It is therefore crucial to evaluate new therapeutic alternatives, when faced to a decreasing medical demography and an increase the patient's needs.

This study should allow to validate the possibility to delegate monitoring tasks to orthoptists during glaucoma surveillance. To organize the delegation of this surveillance to orthoptists would permit a better distribution of the ophthalmologist's activities.


Eligibility criteria: Inclusion Criteria:

* Age from 18 years old or more
* Open-angle glaucoma or ocular hypertension

Exclusion Criteria:

* Other active ocular pathology
* Monophthalmic patients
* Patients requiring a Goldmann visual field exam
* Opposition of the patient to participate to the trial
* Pregnant women or breastfeeding
* Patient under juridical protection
* Lack of affiliation to social security or universal health coverage

Primary outcomes:
measure: detection by the orthoptists of an abnormality that would require an anticipated ophthalmologic consultation
timeFrame: 20 month of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre hospitalier
city: Boulogne Billancourt
country: France
facility: Hôpital Ambroise-Paré
city: Grenoble
country: France
facility: Clinique Universitaire d'Ophtalmologie
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
References:
Clinical trial NCT04329585: GABA Antagonist to Improve Reversal of Anesthesia With High-density EEG Surveillance
Official title: GABA Antagonist to Improve Reversal of Anesthesia: a Double Blind Study With High-density EEG Surveillance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Moderate Sedation
Colonoscopy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: For recent years, patients are more likely to accept sedation during endoscopic examination due to better quality and experience. Modest anesthetic state for different kind of procedure is important, but it is also not easy to maintain in the same state all the time. Thus, to prevent awareness during the procedure, monitoring the brain state is an important issue. Traditionally, anesthesiologists assess patients' brain state from heart rate, blood pressure and muscle tone. All these vital signs are indirect hint for the real brain state. Thus, electroencephalogram(EEG) was considered to be potential tool to directly monitor our brain during anesthesia. In 1937, EEG study was started in anesthetic patients. Until 1994, Bispectral Index, the first commercialized processed EEG monitor, was published for intra-operative brain state assessment. To perform EEG study on a surgical patient is not easy due to the complex circuits and lots of interrupts during the procedure. This might be the reason why most of the EEG studies under anesthesia are collecting from healthy volunteers. It takes longer preparation, better team cooperation, and support from hospital to start this study in endoscopy room.

The investigators would like to start from a preliminary study, 5 patients in each groups, and collect the EEG during peri-endoscopic period. The sedation steps follow the routine protocol of our practice. Flumazenil and placebo are given to the groups separately on the end of the examination. From this study, further understanding of human brain during sedation especially in such short periods is expected. And furthermore, to give safer and more comfortable anesthetic experience for the patients.


Eligibility criteria: Inclusion Criteria:

* ASA I or II
* plan to do colonoscopy

Exclusion Criteria:

* existed CNS disease or injuries
* known allergy to propofol, midazolam or alfentanil

Primary outcomes:
measure: The characteristic differences in EEG
timeFrame: Start from the colonoscopy to 30 minutes after the end of colonoscopy.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
Study officials:
References:
Clinical trial NCT04918485: Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients
Official title: Effect of Preoperative Psychological Intervention on the Degree of Cooperation During Tracheal Catheter Extubation in Patients Under General Anesthesia During Awakening Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 162
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The patients in the experimental group received the relevant knowledge education in the recovery period 30 minutes before anesthesia. The operation time, anesthesia time, cooperation degree score, total cooperation rate and patient satisfaction were observed and recorded. Results: there was no significant difference in operation time and anesthesia time between the experimental group and the control group (P \< 0.05). The percentage of patients in the experimental group was 20.12% and 70.89% respectively, while that in the control group was 40.32% and 20.73% respectively (P \< 0.05). The total cooperation rate was 95.00% in the experimental group and 77.00% in the control group. There was significant difference between the two groups (P \< 0.05). The satisfaction of patients in the experimental group was 95%. 65% of the patients in the control group were satisfied (P \< 0.05). Conclusion: preoperative psychological intervention for patients with general anesthesia and endotracheal intubation can significantly reduce the restlessness and uncooperative phenomenon during extubation, and improve the cooperation rate and satisfaction of patients.


Eligibility criteria: Inclusion Criteria:

the patients who will undergo cholecystectomy surgery

Exclusion Criteria:

the patients who can not well communicate

Primary outcomes:
measure: The total cooperation rate
timeFrame: through study completion, an average of half a year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd affiliated hospital, school of medicine, Zhejiang University
state: Zhengjiang
Study officials:
References:
Clinical trial NCT02079285: Prospective Evaluation of Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy (EUS-FNAB) in the Absence of Rapid Onsite Evaluation
Official title: Prospective Evaluation of the Yield and Diagnostic Accuracy of Endoscopic Ultrasound-guided Fine Needle Aspiration and Biopsy in the Absence of Rapid Onsite Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 75
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion

Brief summary: \<Background/aims\> Rapid onsite evaluation (ROSE) of endoscopic ultrasound-guided fine needle aspiration and biopsy (EUS-FNAB) specimens by attending cytopathologists has been demonstrated to improve diagnostic yields of EUS-FNAB. The practice of ROSE, however, varies across EUS programs in Unites States, Europe and other areas of world. The investigators have a plan to perform prospective evaluation of the yield of EUS-FNAB in the absence of ROSE, in which the adequacy of specimens will be assessed by a single endosonographer.

\<Methods\> All EUS-FNAB procedures will be performed by an experienced endosonographer and the adequacy of specimens obtained during EUS-FNAB will be also assessed by a same endosonographer. A specimen will be considered adequate if there is an adequate number of representative cells from the lesion. Samples considered to be adequate will be then interpreted as malignancy, highly atypical suggestive of malignancy, atypical favor reactive change, or negative for malignancy. Performance characteristics of EUS-FNAB including sensitivity, specificity, and accuracy will be determined by comparing EUS-FNAB results with the final diagnoses of the lesions, based upon the surgical pathology or clinical follow-up of more than 6 months with repeat imagings.


Eligibility criteria: Inclusion Criteria:

* Any patients who will undergo EUS-FNA for the diagnostic evaluation of pancreas lesion

Exclusion Criteria:

* Patients who refuse to undergo EUS-FNA

Primary outcomes:
measure: Sensitivity, specificity and accuracy of EUS-FNA without ROSE
timeFrame: 7 days
Secondary outcomes:
measure: Adequacy of obtained cytologic specimens
timeFrame: 7 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Sungkyunkwan University Kangbuk Samsung Hospital
Study officials:
References:
Clinical trial NCT02253485: Efficacy of Antiviral Therapy in Pregnancy in Preventing Vertical Transmission of HBV in Mothers With a High Viral Load
Official title: Case-control Study of Antiviral Therapy During Entire and the Third Trimester of Pregnancy in Preventing MTCT of HBV in Mothers With High Serum HBV DNA Load
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immune Globulin, Prophylaxis, Telbuvidine, Vaccine
Keywords: Mother-to-child transmission
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2014-10-01
Enrollment: 600
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: this study would enroll 600 HBsAg positive mothers, including 240 cases with high serum HBV DNA load during pregnancy, 120 cases treated with antiviral therapy for hepatitis B, 120 cases with HBV DNA negative during pregnancy, 120 cases with high serum HBV DNA but receive antiviral therapy in late of pregnancy, and all of their infants.

Brief summary: Mother-to-child transmission (MTCT) is the most common route of hepatitis B virus (HBV) infection. After given standard immunoprophylaxis, MTCT still occurred in some infants born to a HBsAg positive mothers with high HBV DNA load. The main purpose of this study is evaluating the efficacy of methods used in blocking MTCT of HBV in infants born to a HBsAg positive mothers with high serum HBV DNA loads.

Detailed description: This study contain 600 patients and compose groups as follow: (ⅰ) infants born to a HBsAg positive mothers with high HBV DNA load before delivery receive standard immunoprophylaxis( injection of HBIG 200IU at birth plus HBV vaccine at 0,1 and 6month); (ⅱ) infants born to a HBsAg positive mother with high HBV DNA load before delivery, and based on standard immunoprophylaxis receive addition injection of HBIG 200IU at 1 month after birth; (ⅲ) infants born to a HBsAg positive and high HBV DNA load mothers but treated with antiviral therapy in late pregnancy, receive standard immunoprophylaxis; (ⅳ) infants born to a HBsAg positive mothers treated with antiviral therapy during entire pregnancy for hepatitis receive standard immunoprophylaxis; (ⅴ) infants born to a HBsAg positive mother with serum HBV DNA negative receive standard immunoprophylaxis.

Eligibility criteria: Inclusion Criteria:

* infants born to HBsAg positive mother HBsAg positive mother

Exclusion Criteria:

* mothers coinfected HIV or HCV

Primary outcomes:
measure: mother-to-child transmission of HBV
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beijing Ditan Hospital
name: Wei Yi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yi W, Li MH, Xie Y, Wu J, Hu YH, Zhang D, Zhang Y, Cao WH. Prospective cohort study on the efficacy and safety of telbivudine used throughout pregnancy in blocking mother-to-child transmission of hepatitis B virus. J Viral Hepat. 2017 Nov;24 Suppl 1:49-56. doi: 10.1111/jvh.12788.
Clinical trial NCT01695785: Perception of Physical Exertion in Healthy Weight and Obese Adolescents
Official title: Perception of Physical Exertion in Healthy Weight and Obese Adolescents: A Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physiological Response to Exercise
Perception of Exercise Difficulty
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy weight and obese adolescents from the community

Brief summary: Little is known regarding the relationship between perceived and physiological exertion in adolescents. The purpose of this study is to investigate the association between physiological and perceptual markers of effort during exercise and the relationship of these markers to other health-related behaviors in healthy weight and obese adolescents.


Eligibility criteria: Inclusion Criteria:

* Healthy weight (\>5th-85th BMI percentile) or obese (\>95th BMI percentile)
* male and female adolescents, 13-18 years
* Approval to participate in a submaximal and maximal treadmill test received from the adolescent's pediatrician.

Exclusion Criteria:

* Underweight (\<5th BMI percentile)
* overweight (85 - \<95th BMI percentile)
* evidence/reporting of significant cardiovascular disease, cardiac arrhythmias, liver disease, or the chronic use of medications including diuretics, steroids and adrenergic-stimulating agents.
* Adolescents with emotional problems such as clinical depression or other diagnosed psychological condition and currently use prescription medication for psychological conditions.
* Approval to participate in a submaximal and maximal treadmill test from the adolescent's pediatrician not obtained

Primary outcomes:
measure: Physiological responses to submaximal and maximal treadmill exercise
timeFrame: 7-10 days
Secondary outcomes:
measure: Perceptual responses to submaximal and maximal treadmill exercise
timeFrame: 7-10 days
Other outcomes:
measure: Physical activity intention
timeFrame: 7 days
measure: Physical activity behavior
timeFrame: 7 days
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Connie Tompkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03553485: Effects of VNS on RT-induced Inflammation and Prognosis of Patients With NSCLC
Official title: Effects of Transcutaneous Auricular Vagal Nerve Stimulation on Radiotherapy-induced Inflammation and Prognosis of Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer, Non-small Cell
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: Kom Op Tegen Kanker
First posted: 2018-06-12
Enrollment: 12
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: Lung cancer (LC) remains a leading cause of death among cancers worldwide. Though radiotherapy is one of the most frequently used treatments, it increases side-effects (pain, fatigue) and inflammation, possibly leading to further tumorigenesis of surviving cancer cells. The purpose of this study is to test the effects of transcutaneous auricular VNS vagal nerve stimulation (taVNS), known to reduce inflammation, on radiotherapy-induced inflammation and other side-effects in LC patients undergoing radiotherapy.

In this feasibility study 12 patients with NSCLC stage III (A/B) receiving radiotherapy will be enrolled. Our primary endpoint is the effect of vagus nerve stimulation (VNS) on inflammatory levels (such as CRP and cytokines), immunological factors (neutrophils, monocytes, lymphocytes) and the tumor marker CEA. Our secondary endpoint is the psychological well-being and quality of life of the patients during their radiotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years old
* Patients with non-small cell lung cancer stage III (A or B)
* Patients receiving radiotherapy or chemoradiotherapy
* Patients with an HRV \< 70 msec

Exclusion Criteria:

* Patients with an active implantable medical device, such as a pacemaker, hearing aid implant or any other implanted electronic device
* Patients with an implanted or wearable defibrillator.
* Patients with myocardial disease
* Patients with arrhythmias
* Patients with an implanted metallic or electronic device in their head.
* Pregnant or breastfeeding women

Primary outcomes:
measure: Cancer prognosis: tumor marker
timeFrame: 7 weeks
measure: Cancer prognosis: inflammatory level
timeFrame: 7 weeks
measure: Cancer prognosis: inflammatory level
timeFrame: 7 weeks
measure: Cancer prognosis: immunological factors
timeFrame: 7 weeks
Secondary outcomes:
measure: Health related Quality of Life
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussels
Study officials:
affiliation: VUB
name: Reijmen, Dra
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01837485: Probiotics in the Treatment of Irritable Bowel Syndrome
Official title: Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome
Functional gastrointestinal disorders
Gut flora
Probiotics
Lead sponsor: Islamic Azad University, Najafabad Branch
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 82
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: TREATMENT

Brief summary: Some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. Because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 65
* diagnosis of IBS based on the Rome III criteria
* willingness to participate

Exclusion Criteria:

* receiving other probiotics compound during the study
* receiving antibiotics during the study

Primary outcomes:
measure: Abdominal pain
timeFrame: Up to 3 months
measure: Constipation
timeFrame: Up to 3 months
measure: Diarrhea
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Islamic Azad University, Najafabad Branch
name: Mozhdeh Zahiri, MD
role: PRINCIPAL_INVESTIGATOR
References: