louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01924494: Gastro Intestinal Tele Endoscopy Project
Official title: Gastrointestinal Tele-Endoscopy Project: Synchronous Tele-Endoscopy - A Clinical Feasibility Study of Implementation of EndoAlpha Platform in Gastrointestinal Endoscopy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Investigate the Potential Network Limitations
Validate the Technology for Later Clinical Use
Evaluate System Integration of EndoAlpha
Keywords: telemedicine, tele-endoscopy
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2013-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective gastrointestinal endoscopy procedures

Brief summary: Synchronous Tele-Endoscopy: A clinical feasibility study of gastrointestinal tele-endoscopy by implementing and evaluating synchronous tele-endoscopy using ENDOALPHA in a hospital based endoscopy unit. EndoAlpha will be used on the hospitals existing Intranet/LAN and the possibilities of tele-endoscopy on WAN through existing network, on separate dedicated line or through new established transmission lines, will be evaluated. The EndoAlpha system will be integrated in a highly advanced endoscopy procedure room. The system will integrate through LAN with doctor office, clinic conference and lecture room and GI pathologist room. Through either LAN or WAN, connection will be establish to a referral GI center in Denmark. Through WAN, connection will be established to doctor home and to an expert Spanish center.

Detailed description: Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality. Validate the tele-endoscopy technology for consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching, training and supervision of basic and advanced therapeutic procedures).

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective gastrointestinal endoscopic procedures

Exclusion Criteria:

* Age \< 18 years or \> 90 years
* Unwilling to participate (no informed consent)
* Not able to understand and read Danish
* Emergency endoscopic procedures

Primary outcomes:
measure: Evaluate the potential network (LAN +WAN) limitations for video transmission image quality and audio transmission (two-way) quality.
timeFrame: 1 year
Secondary outcomes:
measure: Validate the tele-endoscopy technology for consulting and second opinion in diagnostic endoscopy and therapeutic endoscopy (teaching, training and supervision of basic and advanced therapeutic procedures).
timeFrame: 2 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Endoscopy Unit, Bispebjerg Hospiatl
Study officials:
References:
Clinical trial NCT06765694: Efficacy of One or Two Botulinum Toxin Injections in the Treatment of Chronic Lateral Epicondylalgia: a Retrospective Study (EPITOX)
Official title: Efficacy of One or Two Botulinum Toxin Injections in the Treatment of Chronic Lateral Epicondylalgia: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Lateral Epicondylitis
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with chronic lateral epicondylitis already treated by physiotherapy, shock wave therapy, steroid injections without relief of pain

Brief summary: Despite being a self-limiting injury, lateral epicondylitis (LE) can be difficult to manage. In cases of refractory LE, conservative treatment fails and symptoms persist over 6 months. Previous studies have investigated the role of botulinum Toxin Type A (BoNT-A) injections in LE with controversial results. There is some evidence that repeating the BoNT-A injection could be beneficial for refractory cases.

The objective is to assess the success rate of one or two BoNT-A injections for refractory LE.


Eligibility criteria: Inclusion Criteria:

lateral epicondylitis at least one botulinum injection

Exclusion Criteria:

* none

Primary outcomes:
measure: pain improvement
timeFrame: from enrollment to 6 months
Secondary outcomes:
measure: adverse events
timeFrame: from enrollment to 6 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
References:
Clinical trial NCT00543894: Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients
Official title: Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients. A Prospective, Observational, Multicenter Study (ANTHICUS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection in ICU
Keywords: Antibiotic, ICU, hospital acquired infection.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 500
Standard ages: CHILD
ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: Antibiotic Therapy for Hospital-Acquired Infections in ICU Patients. A prospective, observational, multicenter study (ANTHICUS).


Eligibility criteria: Inclusion Criteria:

* Patients with hospital-acquired infections and hospitalised in the ICU at one moment of their hospital stay
* Hospital-acquired infections accounting for eligibility are:

  * nosocomial pneumonia (including ventilator-associated pneumonia)
  * bacteremia
  * intra-abdominal infections
  * urosepsis

Primary outcomes:
Secondary outcomes:
measure: the frequency of appropriate antibiotic therapy (defined as the use of antibiotic(s) with "in vitro" efficacy against the identified pathogens responsible for the infection)
measure: the frequency of "the strategy of de-escalation" according to the culture results
Other outcomes:
Locations:
Study officials:
affiliation: UZ Gents
name: Pr Vogelaers
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03523494: Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography
Official title: Feasibility of Lymph Edema-induced Reticulation Subtraction Based on Computerized Tomography.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphedema
Secondary Lymphedema
CT
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs

Brief summary: Development of lympho-proliferation reticulation quantification using CT.

Detailed description: It is known that fibrosis of the subcutaneous soft tissue progresses over time in the lymph edema, and this change progresses to reticulation pattern.

Authors will develop a digital subtraction technique for the extraction of lympho-proliferative reticulation using the Housfield unit of non-reticulation structure (bones, muscles, tendons, vessels, nerves) in the axial image of CT.

Based on the medical records, authors will develop an early diagnosing tool by checking the correlation of the values derived the new technique with circumference, multi-frequency bio-electric impedance analysis, ISO sub-stage, and lymphascintigraphy, and qualify the cut-off values showing high sensitivity and specificity through the receiver operating characteristics (ROC) curve analyses.

Eligibility criteria: Inclusion Criteria:

* In- and out-patients who was diagnosed a secondary lymphoma and undertook CT on their limbs

Exclusion Criteria:

* Primary lymph edema (congenital lymph edema, lymph edema precox, lymph edema tarda)
* Lymph edema simultaneously involving both limbs
* Patients who undertook implantation of electrical devices such as cardic pacemakers

Primary outcomes:
measure: Reticulation Ratio from Computerized Tomography
timeFrame: 1 week
Secondary outcomes:
measure: Multi-frequency bio-electric impedance analysis
timeFrame: 1 week
Other outcomes:
measure: International Society of Lymphology stage
timeFrame: 1 week
measure: lymphascintigraphy stage
timeFrame: 1 week
measure: circumference between normal and involved limbs
timeFrame: 1 week
Locations:
city: Ulsan,
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Koo KI, Ko MH, Lee Y, Son HW, Lee S, Hwang CH. Comparison of a novel algorithm quantitatively estimating epifascial fibrosis in three-dimensional computed tomography images to other clinical lymphedema grading methods. PLoS One. 2019 Dec 10;14(12):e0224457. doi: 10.1371/journal.pone.0224457. eCollection 2019.
Clinical trial NCT00681694: Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer
Official title: Long-Term Outcomes of Alternative Brachytherapy Techniques for Early Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Keywords: brachytherapy
radioactive seed implants
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
name: Brigham and Women's Hospital
name: Beth Israel Deaconess Medical Center
name: Metro West Medical Center
name: United States Department of Defense
First posted: 2008-05-21
Enrollment: 414
Sex: MALE
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: Patients who have indicated their intention to receive brachytherapy at one of the four accrual sites.

Brief summary: The purpose of this research study is to assess outcomes of treatment for early prostate cancer. Current treatments for early (non-metastatic) cancer may cause long-term impairments in the patients quality of life. In this study we will compare the outcomes of patients treated with two alternative brachytherapy (seed implants) techniques using a series of questionnaires.

Detailed description: Participants will be asked to complete a questionnaire about their health prior to treatment, at 1, 3 and 12 months after treatment and then once a year 4 more times.

Eligibility criteria: Inclusion Criteria:

* Pathological diagnosis of an adenocarcinoma of the prostate
* 18 years of age or older
* Prior choice of either standard brachytherapy or MRIGPB as primary treatment

Exclusion Criteria:

* Prior primary therapy (surgery or external beam radiation) for prostate cancer
* Current hormone ablation therapy

Primary outcomes:
measure: To assess changes in generic and disease specific quality of life over time after treatment with brachytherapy for early prostate cancer
timeFrame: 10 years
Secondary outcomes:
measure: To compare these outcomes after two alternative brachytherapy techniques, standard ultrasound guided brachytherapy and MRI guided prostate brachytherapy (MRIGPB)
timeFrame: 10 years
measure: To identify factors associated with specific adverse outcomes.
timeFrame: 10 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute/Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: James Talcott, MD, SM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01438294: Exercise Training in Asthma Children
Official title: Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
childhood
exercise
Lead sponsor: Hospital Sirio-Libanes
Sponsor class: OTHER
Collaborators: name: University of Nove de Julho
First posted: 2011-09-22
Enrollment: 36
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the effects of a physical training program with active video game in inflammatory markers, quality of life variables , clinical control and physical and functional respiratory assessment of asthmatic children from 5 to 11 years.

Detailed description: The aim of the present study will be to determine whether an aerobic exercise using an active video game system improves asthma control, lung inflammation and functional capacity in children with moderate or severe asthma.

Eligibility criteria: Inclusion Criteria:

* Ages 5 to 11 years;
* Having a diagnosis of asthma, according to the criteria of the National Heart, Lung, and Blood Institute, and
* Not be included in any program of regular physical activity.

Exclusion Criteria:

* Having received aminophylline and theophylline or oral corticosteroids in the last 30 days;
* Respiratory infection have shown over the past two months;
* Have done with inhaled bronchodilator in less than 12 hours before the assessment;
* Inability to perform any of the tests;
* Have heart disease of inflammatory origin, congenital or ischemic;
* Being in the presence of any infectious process with fever and
* Do not agree to the terms of consent

Primary outcomes:
measure: Exhaled Nitric Oxide (FeNO) Level
timeFrame: The FeNO level was performed in week 8
Secondary outcomes:
measure: Treadmil Test (Bruce Protocol)
timeFrame: 8 week distance walked on treadmill test
measure: Body Composition
timeFrame: baseline and after 8 weeks
measure: Pulmonary Function
timeFrame: baseline and after 8 weeks
Other outcomes:
measure: Asthma Control Questionnaire (ACQ6) - Clinical Control of Disease
timeFrame: clinical control week 8
measure: Energy Expenditure
timeFrame: baseline and during all training sessions 8 weeks
Locations:
city: São Paulo
country: Brazil
facility: University Nove de Julho
state: SP
Study officials:
affiliation: University of Nove de Julho
name: Evelim Leal F DantasGomes, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Nove de Julho
name: Dirceu Costa, PhD
role: STUDY_CHAIR
affiliation: University of Nove de Julho
name: Luciana Maria M Sampaio, PhD
role: STUDY_DIRECTOR
References:
citation: Gomes EL, Carvalho CR, Peixoto-Souza FS, Teixeira-Carvalho EF, Mendonca JF, Stirbulov R, Sampaio LM, Costa D. Active Video Game Exercise Training Improves the Clinical Control of Asthma in Children: Randomized Controlled Trial. PLoS One. 2015 Aug 24;10(8):e0135433. doi: 10.1371/journal.pone.0135433. eCollection 2015.
Clinical trial NCT03314194: Plant Based Diet, Ethnicity, and the Gut Microbiome
Official title: Plant Based Diet, Ethnicity, and the Gut Microbiome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Microbial Colonization
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: Seth Bordenstein
First posted: 2017-10-19
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre Post Design
Primary purpose: BASIC_SCIENCE

Brief summary: Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.

Detailed description: To characterize the human gut microbiome under highly controlled dietary intake in healthy normal weight adult participants who differ by ethnicity: White non-Hispanic and Black non-Hispanic adults. Samples will be collected to determine human genetic variation, fecal and oral microbial communities, and metabolome products. Several evolutionary and ecological diversity metrics will be distilled to test: a) if microbiome variation within each ethnicity is less than that between ethnicities; b) if microbiome variation is finely structured according to genetic relatedness; and c) if dietary variation impacts human genome x microbiome associations.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 18-40
* BMI 18.5-24.9
* Caucasian or African American

Exclusion Criteria:

* Not weight stable
* Using Medications
* Using Dietary Supplements
* Chronic Disease
* Tobacco Use
* Drug Use
* Pregnant or Lactating
* Diet Restrictions
* Vegetarian or Vegan

Primary outcomes:
measure: Microbial Community Profile
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Research Associate Professor
name: Heidi J Silver, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li J, George Markowitz RH, Brooks AW, Mallott EK, Leigh BA, Olszewski T, Zare H, Bagheri M, Smith HM, Friese KA, Habibi I, Lawrence WM, Rost CL, Ledeczi A, Eeds AM, Ferguson JF, Silver HJ, Bordenstein SR. Individuality and ethnicity eclipse a short-term dietary intervention in shaping microbiomes and viromes. PLoS Biol. 2022 Aug 23;20(8):e3001758. doi: 10.1371/journal.pbio.3001758. eCollection 2022 Aug.
Clinical trial NCT03331094: Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft
Official title: Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: every patient with a scoliosis responding to the criteria above recovering for surgery

Brief summary: The objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.


Eligibility criteria: Inclusion Criteria:

* age \>18
* under guardianship
* vertebral deformation \>20°
* accept to participate

Exclusion Criteria:

* minor patient
* surgery not including the pelvis

Primary outcomes:
measure: change of Cobb angle
timeFrame: change from baseline Cobb angle at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: WOLFF Stephane, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02885194: Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease
Official title: Impact of Subthalamic Nucleus Deep Brain Stimulation on Pain in Parkinson Disease : Clinical and Neurophysiological Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Pain
Deep Brain Stimulation
Laser-Evoked Potentials
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 26
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Pain is a common symptom of Parkinson's disease (PD) but the physiology remains poorly understood. Recent work suggests that subthalamic nucleus deep brain stimulation (STN-DBS) could make a profit on the pain in PD.

The investigator would drive a study with a follow up of PD patients before and after STN-DBS. The pain will be clinically explored by targeted questionnaires and electrophysiological through laser evoked potentials.

The questionnaires are designed to quantify and characterize the pain in these patients. Laser evoked potentials will, through repetitive stimulation, study both the functional status of the afferent nociceptive pathways, their habituation to repetitive nociceptive stimuli, and so better understand any abnormalities of the central processing of nociceptive information.


Eligibility criteria: Inclusion Criteria:

* A patient with idiopathic Parkinson's disease
* Age between 30 and 70 inclusive.
* No cognitive decline (MMS greater than or equal to 24)
* Normal brain MRI
* Informed consent signed
* With or without pain sensation

Exclusion Criteria:

* Presence of other neurological pathology that could explain the pain.
* MMS less than 24
* Pregnant or breastfeeding women

Primary outcomes:
measure: Modification of habituation in percentage, between tests performed before and after DBS
timeFrame: After the second laser evoked potential which occurred around 3 months after STN-DBS
Secondary outcomes:
measure: Change in latency of laser evoked potential responses before and after DBS
timeFrame: After the second laser evoked potential which occurred around 3 months after STN-DBS
measure: Change in amplitude of laser evoked potential responses before and after DBS
timeFrame: After the second laser evoked potential which occurred around 3 months after STN-DBS
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie C, Hôpital Neurologique, HCL
Study officials:
affiliation: Hospices Civils de Lyon
name: Stéphane THOBOIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00143494: The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure
Official title: The Estimation of Abdominal Pressure by the Bladder and Gastric Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critically Ill Patients
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2005-09-02
Enrollment: 13
Sex: MALE
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators aim to compare the bladder pressure to the gastric pressure in critically ill patients.

Detailed description: In critically ill patients, we will measure the gastric pressure by a gastric balloon and the bladder pressure by the intra-vesical pressure to find the optimal method to estimate the abdominal pressure.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients during invasive mechanical ventilation

Exclusion Criteria:

* Contraindication to measure the bladder pressure

Primary outcomes:
measure: To estimate the bladder pressure
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Policlinico Hospital
Study officials:
affiliation: Policlinico Hospital
name: davide chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiumello D, Tallarini F, Chierichetti M, Polli F, Li Bassi G, Motta G, Azzari S, Carsenzola C, Gattinoni L. The effect of different volumes and temperatures of saline on the bladder pressure measurement in critically ill patients. Crit Care. 2007;11(4):R82. doi: 10.1186/cc6080.