louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06012643: Subperiosteal Implants Constructed With Digital Technology
Official title: Subperiosteal Implants as a Treatment for Severely Atrophied Jaw in Completely and Partially Edentulous Population: A Systematic Review of Case Reports and Case Series.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alveolar Bone Loss
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 23
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions in the last 5 years.

Brief summary: Atrophied jaw is a condition where there is insufficient bone quantity to place root form implants. Several treatment plans are available for treating atrophied jaws, including subperiosteal implants. Subperiosteal implants were introduced in the last century. Poor clinical results led those implants to be progressively abandoned. Recently, several Authors suggested a revival of subperiosteal implants as an alternative to regenerative procedures.

Detailed description: An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions that reported on subperiosteal implants management of patients with severely atrophied jaws in completely and partially edentulous population.

The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.

Eligibility criteria: Inclusion Criteria:

* population with partial or fully edentulous arches, in particular Cawood and Howell class (IV-VI);

Exclusion Criteria:

* Articles were excluded if complex reconstructive surgery including bone grafts, barrier membranes, jaw osteotomies, sinus lift, alveolar ridge distraction, and zygomatic implants was recommended for treatment

Primary outcomes:
measure: to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.
timeFrame: 5 year retrospective
Secondary outcomes:
measure: Biological complications
timeFrame: 5 year retrospective
Other outcomes:
measure: Prosthetic complications
timeFrame: 5 year retrospective
Locations:
city: Multiple Locations
country: Egypt
facility: Mohammed El Sawy
Study officials:
affiliation: Mansoura University
name: Mohammed ELSawy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06455943: Evaluation of Thriving, Substance Use, Mental Health, and Repeat Injury Among Participants in the THRIVE Program
Official title: Evaluation of Thriving, Substance Use, Mental Health and Repeat Injury Among Participants in the THRIVE Program
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Violence
Assault
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth injured by interpersonal violence who present at the emergency department of Unity Health Toronto - St. Michael's Hospital will be offered the hospital-based violence intervention program called THRIVE. THRIVE case managers connect with youth and provide supports in-hospital and in the community following discharge, providing wrap-around care with a strengths-based approach.

Brief summary: The goal of this observational study is to determine the impact of a hospital-based violence intervention program on a person's capacity to thrive and recurrent intentional injury. The aims of this study are:

1. To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive using:

   * Established measure changes in positive psychology and clinical metrics
   * A qualitative interview using thematic content analysis
2. Plot the methodology proposed to measure the impact of THRIVE on subsequent injuries using administrative data sources

Participants will complete surveys, participate in a semi-structured interview, and have their rate of recurrent intentional injury tracked over time.

Researchers will compare the rates of intentional reinjury between participants in the THRIVE program and those who present at other hospitals with similar injuries to see if there is a difference in the rate of recurrent intentional injury a 1, 5, and 10 years.


Eligibility criteria: Inclusion Criteria:

* ages 14-29
* presentation with an injury due to violence (defined as a gun shot wound, stab wound, blunt or bodily force, inflicted by someone else)
* participant in the THRIVE Program

Exclusion Criteria:

* unable to consent due to language barrier or brain injury
* sexual assault
* child abuse
* self-inflicted injury
* residence \>1 hour from Toronto city limits

Primary outcomes:
measure: To evaluate the impact of the HVIP on building personal capacity of youth who have experienced non-fatal violent injuries to thrive.
timeFrame: July 2024 - December 2025
measure: To pilot the methodology proposed to measure the impact of THRIVE on subsequent injuries within 1 year using administrative data sources
timeFrame: March - Sept 2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Carolyn Snider, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03296943: Efficacy of Inhalation of Essential Oil on the Reduction of Inhalants Craving
Official title: A Novel Approach of Substitution Therapy With Inhalation of Essential Oil for the Reduction of Inhalants Craving: A Double-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inhalants Craving
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Inhalants, which are neurotoxic central nervous system (CNS) suppressants, are frequently abused by young adults. Unlike other CNS depressants, including alcohol and opiates, no treatment is currently approved for inhalants dependence. In this report, a novel approach of substitution treatment for inhalants addiction was explored in a double-blinded, randomized, controlled crossover design to examine the effects of inhalation of essential oil (EO) and perfume (PF) on the reduction of cue-induced craving for inhalants in a cohort of thirty-four Thai males with inhalants dependence. The craving response was measured by the modified version of Penn Alcohol Craving Score for Inhalants (PACS-inhalants)


Eligibility criteria: Inclusion Criteria:

* Participants with ability to smell if they could correctly identify 3 out of 5 odors, namely fish sauce, lemon, onion, basil, and jasmine.
* Individuals with inducible picture-cues inhalant craving based on a 50% increase in craving score from baseline.

Exclusion Criteria:

* Individuals with a history of major psychiatric disorders, including psychotic and mood disorders
* Individuals with illicit substance dependence other than inhalants
* Individuals with allergic reactions to essential oil or perfume.

Primary outcomes:
measure: Inhalants craving - PACS
timeFrame: Daily for 3 days
measure: Inhalants craving - VAS
timeFrame: Daily for 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Thani
country: Thailand
facility: Princess Mother National Institute on Drug Abuse Treatment
Study officials:
affiliation: Chulalongkorn University Faculty of Medicine
name: Rasmon Kalayasiri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02034643: Transesophageal Echocardiography(TEE) Probe Insertion and Tracheal Cuff Pressure
Official title: Increase of Tracheal Cuff Pressure During Transesophageal Echocardiography Probe Insertion: Double-lumen Tube Versus Single-lumen Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation, Intratracheal
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-01-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tracheal cuff overinflation is known to reduce tracheal mucosal blood flow and to increase tracheal morbidity. Transesophageal echocardiography (TEE) probe insertion may increase the tracheal cuff pressure. The aim of this study is to evaluate the effect of TEE probe insertion on tracheal cuff pressure and to compare the effects in single-lumen tube and double-lumen tube.


Eligibility criteria: Inclusion Criteria:

* adult patients scheduled for elective cardiothoracic surgery
* requiring intraoperative TEE monitoring

Exclusion Criteria:

* patients with tracheal stenosis
* patients with tracheoesophageal fistula
* patients with esophageal surgery
* patients with esophageal varix
* patients with Barrett esophagus
* patients with esophageal hernia
* patients with descending thoracic aorta aneurysm
* patients with dysphagia
* patients with vocal fold palsy

Primary outcomes:
measure: Tracheal cuff pressure
timeFrame: 1 min after TEE probe insertion
Secondary outcomes:
measure: Tracheal cuff pressure
timeFrame: every min for 5 min after TEE probe insertion
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Kim TK, Min JJ, Seo JH, Lee YH, Ju JW, Bahk JH, Hong DM, Jeon Y. Increased tracheal cuff pressure during insertion of a transoesophageal echocardiography probe: A prospective, observational study. Eur J Anaesthesiol. 2015 Aug;32(8):549-54. doi: 10.1097/EJA.0000000000000204.
Clinical trial NCT00936143: Efficacy and Safety Study of Infliximab (Remicade) to Treat Early Ankylosing Spondylitis
Official title: An Open Trial to Evaluate the Efficacy and Safety of Infliximab(Remicade) in Treating Patients With Early Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spondylitis
Keywords: Spondylitis, Ankylosing
infliximab
Antibodies, Monoclonal
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2009-07-09
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective open-label study to evaluated the efficacy and safety of infliximab(Remicade) in treating of patients with early ankylosing spondylitis (AS). Infliximab was injected intra-venous on baseline, 2nd week, 6th week, 12th week and 24th week, with dosing of 5mg/kg. The major outcome index is ASAS20, and minor outcome indexes include ASAS50 and ASAS70, BASDAI20,BASDAI50 and BASDAI70. And MRI of sacroiliac joint is not necessary. The adverse events at any time were recorded.


Eligibility criteria: Inclusion Criteria:

1. 16 to 65 years old, having signed the informed consent;
2. fulfill the ESSG criteria for diagnosis of SpA; not fulfill the 1984 modified NewYork criteria for AS;
3. have inflammatory back pain defined by Calin criteria;
4. disease duration range from 6 months to 2 years;
5. BASDAI score more than 4;
6. MRI score of sacroiliac joint more than 4;
7. lab examination: hemoglobin more than 90 gram/liter. Aspartate aminotransferase and Alanine aminotransferase less than 2 fold of upper level of normal range. Creatine less than upper level of normal range.

Exclusion Criteria:

1. History of psoriasis or inflammatory bowel disease.
2. Intra-articular injection of cortisone within 3 months.
3. Patients were taking cortisone, SASP or MTX, unless the dose has been stable for at least 3 months.
4. Active iritis.
5. History of heart failure, multiple sclerosis, COPD, lymphoma or other tumor, tuberculosis.
6. Female of pregnancy or breast feeding.
7. History of mental disease and poor compliance.
8. History of drug abuse or alcoholism.

Primary outcomes:
measure: Proportion of patients achieving ASAS20 improvement.
timeFrame: 6th week
Secondary outcomes:
measure: Proportion of patients achieving ASAS50 and ASAS70
timeFrame: 6th week and 24 week.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT05916443: Dissecting the Biology of Early-onset Colorectal Cancer
Official title: Study of the Biology of Colorectal Cancer in Early-onset Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colon Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: National multicenter study, enrolling approximately 30 patients with colorectal cancer, males and females, no pediatric age.

Brief summary: Contrarily to late-onset (LO) colorectal cancer (CRC), early-onset (EO) CRC incidence is increasingly growing. Several factors, such as obesity, chronic inflammation, and intestinal dysbiosis, can increase the general risk of CRC. However, little is known about the biology of EO-CRC. To evaluate whether such selective rise in the incidence of EO-CRC patients mirrors a distinct transcriptomic profile, the investigators will first dissect EO-CRC's transcriptomic landscape.

Then, the investigators will investigate the colorectal cancer stem cell (CSC) compartment by in vitro functional assays and RNA-seq analysis. Because our preliminary data indicate an increased aggressiveness of the tumor microenvironment (TME) in EO-CRC,the investigators propose to investigate the CSC niche and the interaction with the TME to dissect the molecular and cellular pathways occurring in EO-CRC.

A cohort of 30 EO-CRC patients (\<50 years old) will be enrolled and fully characterized. About 10 EO-CRC-derived CSCs in the form of organoids and spheroids will be generated. Since the relevant differences between CR-CSCs isolated from EO-CRC vs LO-CRC patients are still unknown, the investigators will gain information about their specific features such as clonogenic activity, tumorigenic/invasive capacity, and about differences in the mechanisms regulating their cross-talk with TME components.


Eligibility criteria: Inclusion Criteria:

* age \> 18 and \< 50 years ;
* Written informed consent

Exclusion Criteria:

* Non-availability of informed consent.

Primary outcomes:
measure: Isolation and characterization of EO-CRC-derived CSCs
timeFrame: 2 years
measure: Identification of obesity-associated adipokines in EO-CRC obese patients
timeFrame: 2 years
measure: Identification of EO-CRC specific signatures and pathways
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01889043: Monitoring of Non-invasive Ventilation During Sleep in ALS
Official title: Monitoring of Non-invasive Ventilation During Sleep in ALS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Noninvasive Ventilation
Polysomnography
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Amyotrophic lateral sclerosis patients, which are followed at the Neuromuscular Reference Centre UZ Leuven, in need for NIV treatment

Brief summary: Non-invasive ventilation (NIV) has already shown to improve survival and quality of life in patients with amyotrophic lateral sclerosis (ALS). Quality of sleep seems already to be impaired in patients with preserved diaphragmatic dysfunction. Until now, only few research has been performed on the quality of sleep in patients with ALS when using NIV, and these data are mainly based on patient reported outcomes.Further on, only very little research has been done on patient-ventilator interaction.

Our study would like to perform research on quality of sleep before and after NIV use by using full polysomnography with incorporation of transcutaneous carbon dioxide measurement and built-in ventilator software.


Eligibility criteria: Inclusion Criteria:

* Patients with ALS (according to El Escorial criteria) who are planned to start to use NIV, objectivated by a decreased inspiratory muscle force with a restrictive pulmonary function and

  1. symptoms of nocturnal alveolar hypoventilation or
  2. increased daytime arterial carbon dioxide partial pressure (PCO2)(\> 45 mmHg) or
  3. a ≥ 10 mmHg increase in transcutaneous PCO2 during sleep in comparison to a normal awake supine value

Exclusion Criteria:

* Patients \< 18 years
* Patients not willing to start NIV

Primary outcomes:
measure: Change in transcutaneous carbon dioxide and respiratory events
timeFrame: At day 2, 3 and 4 and at 1, 3, 6, 9 and 12 months
measure: Change in patient-ventilator asynchronies
timeFrame: Day 4 and at 1,3,6,9 and 12 months
Secondary outcomes:
measure: Impact of NIV on sympatho-vagal balance
timeFrame: Day 1 and at 1,3,6,9 and 12 months
measure: changes in quality of life by patient reported outcomes
timeFrame: Day 1 and at 1,3,6,9 and 12 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: UZ Leuven
name: Dries Testelmans, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ Leuven
name: Bertien Buyse, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03381443: Participant Satisfaction With Two Different Summative Assessment Methods - a Mixed Method Questionnaire Study
Official title: Participant Satisfaction With Two Different Summative Assessment Methods - a Mixed Method Questionnaire Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessment Evaluation
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 428
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All 5th and 6th year medical students at the University of Bern, Switzerland, study year 2017/2018 and 2018/2019

Brief summary: Participants of Immediate Life Support and Advanced Life Support Courses, where two different summative assessment methods were used are asked about their satisfaction with the assessment method using a questionnaire. Both quantitative questions using an 11-point-Likert scale as well as open-ended qualitative questions will be asked. The primary aim of this study is to find out which variant of summative assessment is perceived by course participants as testing their leadership competency best, immediately after the comparison as well as 1 year later to identify any long-term effects on the students.


Eligibility criteria: Inclusion Criteria:

* All 5th and 6th year medical students at the University of Bern, Switzerland, study year 2017/2018 and 2018/2019

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Participant satisfaction with summative assessment methods during Life Support Courses
timeFrame: directly after assessment and 1 year later
Secondary outcomes:
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University of Bern
Study officials:
affiliation: University of Bern
name: Robert Greif, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT05731843: Drug-drug Interaction Study of Ruzasvir and Bemnifosbuvir
Official title: A Phase 1, Open-Label Study to Evaluate the Potential Drug-Drug Interaction Between Bemnifosbuvir and Ruzasvir and Food-Drug Interaction in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-16
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug-drug interaction study of Ruzasvir and Bemnifosbuvir


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug.
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2.
* Willing to comply with the study requirements and to provide written informed consent.

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2.
* Abuse of alcohol or drugs.
* Use of other investigational drugs within 28 days of dosing.
* Concomitant use of prescription medications, or systemic over-the-counter medications.
* Other clinically significant medical conditions or laboratory abnormalities.

Primary outcomes:
measure: Pharmacokinetics (PK) of BEM
timeFrame: Days 6, 12, 18
measure: Pharmacokinetics (PK) of Ruzasvir
timeFrame: Days 6, 12, 18
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Atea Study Site
state: Montreal, Quebec
Study officials:
References: