louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03805971: Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.
Official title: Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pleural Carcinomatosis
Keywords: pCLE
confocal laser endomicroscopy
pleural carcinomatosis
mesothelioma
optical biopsies
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2019-01-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient refered for a medical thoracoscopy and willing to participate.

Brief summary: Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). It was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. In gastroenterology, this new investigational technique is used in Barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. The investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. The pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.


Eligibility criteria: Inclusion Criteria:

* Every patient refered for a medical thoracoscopy and willing to participate.

Exclusion Criteria:

* \< 18 ans

Primary outcomes:
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies). Qualitative Criteria.
timeFrame: One day.
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
timeFrame: One day
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
timeFrame: One day
measure: Pleural Carcinomatosis Identification (Compared to Standard Biopsies), Quantitative Criteria.
timeFrame: One day
Secondary outcomes:
measure: Quality of the pCLE Acquisition
timeFrame: One day
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: CHU de Liège
Study officials:
affiliation: Centre Hospitalier Universitaire de Liege
name: Olivier Bonhomme, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bonhomme O, Heinen V, Detrembleur N, Corhay JL, Louis R, Duysinx B. Probe-based confocal laser endomicroscopy for pleural malignancies diagnosis. Respirology. 2021 Feb;26(2):188-195. doi: 10.1111/resp.13945. Epub 2020 Oct 1.
Clinical trial NCT00919971: Bispectral Index (BIS) on Ventilated Patients in the Prehospital Setting
Official title: Use of Bispectral Index to Assess Depth of Sedation in Ventilated Patients in the Prehospital Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilation
Keywords: Bi spectral Index
Sedation depth monitoring
Out of hospital ventilated patients
Lead sponsor: Beaujon Hospital
Sponsor class: OTHER
First posted: 2009-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Out of hospital ventilated patients, managed by EMS, aged \> 18

Brief summary: To evaluate the effectiveness of use of the bispectral index for monitoring of depth of sedation in ventilated patients during their prehospital management by a physician- staffed EMS. Hypothesis: there is a correlation between BIS and sedation scores.

Detailed description: The protocol compares BIS values to the RAMSAY score, which is the validated sedation scoring system in the prehospital setting.Ventilated patients receiving sedatives drugs can be included during primary prehospital interventions or interhospital transfers. During primary prehospital interventions, the protocol starts before endotracheal intubation. Depth of sedation is assessed every 5 minutes by the physician of EMS team. Blinded BIS monitoring is performed at the same time and recorded by the nurse at the end of out-of-hospital management. Data are analysed secondarily by the principal investigator.

Eligibility criteria: Inclusion Criteria:

* Age \>= 18
* Ventilated patient

Exclusion criteria:

* None

Primary outcomes:
measure: Correlation between BIS values and RAMSAY score
timeFrame: Instantaneously
Secondary outcomes:
measure: Correlation between BIS values and ATICE score
timeFrame: Instantaneously
Other outcomes:
Locations:
city: Clichy
country: France
facility: François-Xavier DUCHATEAU, MD
Study officials:
References:
Clinical trial NCT03309371: DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc
Official title: DISCOGEL ®: Evaluation of the Procedure DISCOGEL ® in Lumbar Radiculopathy on Slipped Disc
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-10-13
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: every patient with a DISCOGEL treatment between January 2014 and may of 2016

Brief summary: Lumbar disc herniation is the most important and frequent affection in rheumatology. The first treatment is based on an non-steroidal anti-inflammatory drugs.Physiotherapy also is used.But when there is no efficient result, it's usual to propose to the patient corticoid injection, percutaneous intervention or arthrodesis.

Recently DISCOGEL® is a medical device used for lumbar disc herniation. However there is no studies evaluating the benefit and the efficiency of this technic. Since a few years, the rheumatology service of GHPSJ practise this technic using DISCOGEL® with patient resistant to the medical treatment . So the aim is to evaluate the benefit of DISCOGEL® retrospectively.


Eligibility criteria: Inclusion Criteria:

* age\> 18
* lumbar radiculalgy
* lumbar disc herniation described by MRI
* more than 6 weeks
* prescription of DISCOGEL

Exclusion Criteria:

* medical history of surgery at the same stage
* patient under Clopidogrel or prasugrel

Primary outcomes:
measure: Change From Baseline in Pain Scores on the Visual Analog Scale at 2 years
timeFrame: Baseline, 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT03863171: Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique
Official title: Early Diagnosis for Ocular Ischemia Syndrome Using Arterial Spin Labeling Magnetic Resonance Imaging Technique: a Prospective Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ocular Ischemia Syndrome
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 190
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with ocular ischemia syndrome

Brief summary: 1. To evaluate ocular blood perfusion status and the possibility of craniocerebral vascular lesions of patients with ocular ischemia syndrome (OIS) using arterial spin labeling (ASL) magnetic resonance imaging technique.
2. To evaluate the specificity, sensitivity and accuracy of arterial spin labeling (ASL) magnetic resonance imaging technique in OIS diagnosis, compared with the traditional routine examination method.


Eligibility criteria: Inclusion Criteria:

* Ocular ischemia syndrome group: Patients diagnosed with ocular ischemia syndrome;
* Age-related macular degeneration group (Control group): Patients diagnosed with age-related macular degeneration;
* Age: 50-80 years;
* Sex: all;
* Patients signed written informed consent.

Exclusion Criteria:

* Fundus fluorescein angiography (FFA) clear images cannot be obtained due to refractive media problems(such as corneal leukoplakia, severe cataract, vitreous hemorrhage, etc.) ;
* Patients with contraindications for FFA;
* Patients was unable to perform magnetic resonance rmaging (MRI) test;
* Patients with history of bleeding and cerebral infarction;
* Patients with a history of surgery within 3 months;
* Patients who had participated in other clinical trials within 3 months;
* Patients who disagree and refuse to participate in the trial.

Primary outcomes:
measure: Blood Flow (BF)
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Yanling Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06224478: Assessment of Palatal Mucosal Thickness in Different Vertical Skeletal Pattern: a 3D Analysis
Official title: Assessment of Palatal Mucosal Thickness in Different Vertical Skeletal Pattern: a 3D Analysis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Palatal Mucosa Thickness
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone CBCT at Nancy University Hospital, Boston University and in private practice

Brief summary: This study assesses the potential statistical correlation between vertical facial pattern and palatal mucosa thickness.

Data collection : dicom files (CBCT) merged with STL files of n patients for soft tissue visualization

Aim: to volumetrically assess (with CBCT) the palatal mucosa thickness in different vertical facial types to aid clinicians in the planning and placement of orthodontic miniscrews.

Hypothesis : There is no significant difference between the 3 groups studied (i.e. no correlation between palatal mucosa thickness and vertical facial typology).

Detailed description: Study rationale : The use of palatal miniscrew offers the possibility to improve the effectiveness of orthodontic expansion devices. Palatal expanders supported by miniscrew can be applied with different clinical protocols. The palatal mucosa thickness affects the choice of miniscrew length.

Justification for overlaying on STL files: When the lingual dorsum and palatal mucosa are in mutual contact during CBCT examination, it is not possible to distinguish one from the other during subsequent imaging evaluation. Various methods have been proposed to overcome these limitations, including the superimposition of the dicom and stl files: this methodology enables the profile of the palatal mucosa to be distinctly identified in all the analyzed scans.

Eligibility criteria: Inclusion Criteria:

* Full permanent dentition (except for third molar)
* Normal craniofacial development
* Aged \> 16 years
* Complete skeletal maturity (assessed by the cervical vertebral maturation method)
* Absence of previous orthodontic or orthognatic surgical treatment

Exclusion Criteria:

* Absence of any tooth other than the third molar
* Maxillary impacted tooth
* CBCT scans taken without teeth in occlusion/open bite
* Distorting pathologies of the facial mass affecting the palatal zone
* Periodontal or endodontic diseases affecting the bone
* Presence of metallic artifact
* History of previous orthognatic or orthodontic surgeries

Primary outcomes:
measure: Palatal mucosa thickness
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05296278: Efficacy and Biomarker Explanation of IBI-323 + Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged NSCLC
Official title: Efficacy and Biomarker Explanation of IBI-323 Combined With Bevacizumab Plus Platinum Based Chemotherapy on ALK-Rearranged Non-Small Cell Lung Cancer Who Failed From First Line Alectinib
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hunan Province Tumor Hospital
Sponsor class: OTHER
First posted: 2022-03-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to explore the efficacy and biomarker explanation of IBI-323 combined with bevacizumab plus platinum based chemotherapy on ALK-rearranged non-small cell lung cancer who failed from first line Alectinib.


Eligibility criteria: Inclusion Criteria:

* Sign written informed consent before implementing any trial-related procedures;
* Age ≥18 years old and ≤75 years old.
* No limit on the gender.
* Patients diagnosed with Lung Adenocarcinoma ALK-Rearranged Stage IIIA-IV by pathology.
* Patients who failed from first line Alectinib with stable brain metastasis included (Radiotherapy treated Oligo-metastasis).
* According to the Solid Tumor Efficacy Evaluation Criteria (RECIST V1.1), at least one lesion can be measured on imaging. Lesions located in the field of previous radiation therapy may be considered measurable if progression is demonstrated.
* ECOG score 0-1 points.

Exclusion Criteria:

* Patients with contraindication of chemotherapy Pregnant or breast feeding women.
* Participate in another interventional clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
* Participants are known to have had previous severe allergic reactions to other monoclonal antibodies or to any of the components of the IBI323 preparation, and severe allergies to bevacizumab, pemetrexed, cisplatin, and carboplatin.
* Previous systematic anti-tumor therapy for advanced non-squamous NSCLC other than ALK-TKI (including cytotoxic chemotherapy in combination with radiotherapy).
* Previous use of anti-PD-1 anti-PD-L1 anti-programmed death receptor ligand 2(PD-L2) or anti-cytotoxic T-lymphocyte-associated antigen 4(CTLA-4) drugs or any other drugs that act on T-cell co-stimulation or checkpoint pathways (such as OX40 CD137 LAG3, etc.).
* Radical radiation therapy within 28 days prior to the first dose, or palliative radiation therapy within 14 days prior to the first dose.
* Received ALK-TKI treatment within 2 weeks prior to the first administration of the study drug

Primary outcomes:
measure: ORR
timeFrame: 1 year
Secondary outcomes:
measure: OS
timeFrame: 1 year
measure: DCR
timeFrame: 1 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Cancer hospital
state: Hunan
Study officials:
References:
Clinical trial NCT01409278: Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement
Official title: The Evaluation of the Efficacy of Local Infiltration Analgesia and Infusion for Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 105
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: TREATMENT

Brief summary: The purpose of this study is to examine three different ways to control pain after hip replacement:

1. One time injection of ropivacaine before wound closure
2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine via catheter for 48 hours
3. Standard practice of patient controlled pump


Eligibility criteria: Inclusion Criteria:

* total knee replacement

Exclusion Criteria:

* History of neurological disease, diabetes, pregnancy, allergy to local anesthetic solutions chronic narcotic use ability to consent

Primary outcomes:
measure: The pain medication requirement for 48 hours after surgery in three groups.
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Pain scores, incidence of nausea and vomiting and patient satisfaction in each group.
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital
name: Sanjay Sinha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04095078: Ancillary Home Airway Clearance in CF Patients ( HomeCareSIMEOX )
Official title: Efficiency and Acceptability of SIMEOX® Used Autonomously at Home for Bronchial Clearance in Patients With Cystic Fibrosis: Ancillary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Cystic Fibrosis
Keywords: bronchial clearance
cystic fibrosis
Lead sponsor: Physio-Assist
Sponsor class: INDUSTRY
Collaborators: name: Icadom
First posted: 2019-09-19
Enrollment: 56
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, multicenter trial
Primary purpose: TREATMENT

Brief summary: Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree. By changing the rheological properties of mucus, SIMEOX® helps to mobilize secretions and assists their transport to the upper airways. This technology is based on fundamental research on bronchial mucus rheology. At the present time, SIMEOX® device is mainly used over a short period at the time or after an exacerbation in healthcare structures (hospitals, physiotherapy practices, postcare, and rehabilitation units, etc...). The clinical effects observed in the short term encourages long-term autonomous use by the patients themselves. The overall objective of this study is to evaluate the efficiency and acceptability of SIMEOX® used at home by the patient himself for bronchial clearance in patients with cystic fibrosis.


Eligibility criteria: Inclusion Criteria:

* one of the 56 first patients of HOME-CARE SIMEOX study
* same criteria as HOME-CARE SIMEOX study

Exclusion Criteria:

* same criteria as HOME-CARE SIMEOX study

Primary outcomes:
measure: Pulmonary static hyperinflation assessed by residual volume
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Use assessed by the duration of use of SIMEOX® device
timeFrame: During 3 months of use
measure: Inspiratory capacity
timeFrame: Change from baseline at 3 months
measure: Residual functional capacity (RFC)
timeFrame: Change from baseline at 3 months
measure: Total lung capacity (TLC)
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble University Hospital : pneumo-pediatric department
city: Grenoble
country: France
facility: Grenoble University-Affiliated Hospital : Pneumology department
city: Montpellier
country: France
facility: Montpellier Hospital Center
city: Nice
country: France
facility: Nice University-Affiliated Hospital : Pneumology department
city: Nice
country: France
facility: Nice University-Affiliated Hospital : Pneumo-pediatric department
Study officials:
affiliation: CHUGA
name: Boubou Camara, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03763578: Dental Caries Prevention by a Natural Product
Official title: Licorice Versus Standard Preventive Measures for the Prevention of Caries Incidence in Young Egyptian Adults: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.

Detailed description: Research hypothesis (Null hypothesis):

The present clinical trial will be conducted to reject or accept the null hypothesis that using Licorice extract mouth wash in addition to standard preventive measures will not differ from using standard preventive measures alone in preventing incidence of new carious lesions.

PICOTS:

P: Population with high caries risk patients

I: Use of licorice.

I2: Use of chlorhexidine

C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning).

O.1: Primary outcome is incidence of new carious lesions

T: Time for measurement is 12 months

S: A Randomized controlled clinical trial (Parallel study)

Eligibility criteria: Inclusion Criteria:

* Patients with high caries risk,
* 18-25 years,
* Males or females,
* Medically free patients,
* Patients approving to participate in the study.

Exclusion Criteria:

* Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination,
* Patients had history of professional cleaning in the last 15 days,
* Patients with exposed pulp,
* Evidence of parafunctional habits,
* Patients with developmental dental anomalies,
* Patients undergoing or will start orthodontic treatment,
* Patients with removable prosthesis,
* Periapical Abscess or Fistula.

Primary outcomes:
measure: Incidence of new carious lesions
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University
state: Choose Any State/Province
Study officials:
References: