louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05528718: SMILE Trial - Imaging Sub-Study
Official title: Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial - Sub-Study Protocol to Include Neuroimaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient participants were diagnosed as suffering from major depressive disorder (MDD) that meets the criteria of the Diagnosis and Statistical Manual for Mental Disorders (DSM-5), will be eligible to participate in this data collection study. Participants who have agreed to receive N2O treatments as part of the Interventional Psychiatry Clinical Program at St. Michael's Hospital will be approached and recruited.

Brief summary: This is a pilot sub-study of an ongoing trial comparing N2O to midazolam in MDD and will examine neuroimaging correlates of treatment response.

Detailed description: Magnetic resonance imaging (MRI) scans of MDD-affected brains have revealed changes in structural and functional connectivity compared to healthy subjects. This pilot sub-study examines structural and functional connectivity associated with MDD-affected patient participants' responsiveness to N2O compared to the midazolam placebo, which induces similar sedative effects. The investigators intend to address the changes in brain functional activity and connectivity between baseline and after a four-week intervention course involving weekly nitrous oxide inhalations measured by MRI.

Eligibility criteria: Inclusion Criteria:

* Eligible for main nitrous oxide (SMILE) study

Exclusion Criteria:

* Contraindication for undergoing MRI scans (e.g., hip circumference \< 180 cm or metal in the body)

Primary outcomes:
measure: Brain functional activity and connectivity
timeFrame: 4 weeks from the baseline visit
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Venkat Bhat, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06424418: Robotic Scope Cleaning Device
Official title: A Proof of Concept Study Validating The Safety And Efficacy of a Novel Robotic Scope Cleaner
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Lead sponsor: Boehringer Labs LLC
Sponsor class: INDUSTRY
Collaborators: name: NYU Langone Health
First posted: 2024-05-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: A novel device that works with robotic trocars to clean the scope when visualization is compromised during a surgical procedure.


Eligibility criteria: Inclusion Criteria:

* able to consent
* undergoing a surgical robotic procedure

Exclusion Criteria:

* not suitable for a surgical procedure with the robot

Primary outcomes:
measure: feasibility of device
timeFrame: [Estimated 6 months]
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04720118: Parkinson's Disease and Experiences Throughout the COVID-19 Pandemic
Official title: Does Locus of Control Affect Satisfaction and Quality of Life During COVID - 19?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Covid19
Satisfaction, Patient
Quality of Life
Lead sponsor: Towson University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is people, 18 years or older, who are diagnosed with Parkinson's disease.

Brief summary: The purpose of this research study is to examine the relationship between personal characteristics and satisfaction with care in those diagnosed with Parkinson's disease during the COVID-19 pandemic. Participants will take 4 different surveys regarding their satisfaction with care throughout the duration of the COVID-19 pandemic. The surveys in total should not take more than 30 minutes to complete


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Diagnosed with Parkinson's Disease
* Must be able to complete the surveys without any help

Exclusion Criteria:

* Under the age of 18
* Not diagnosed with Parkinson's Disease
* Unable to complete the surveys without help

Primary outcomes:
measure: Measure of the relationship between Locus of Control and Quality of Life
timeFrame: 1 year
measure: Measure of secondary control and satisfaction with care
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Towson
country: United States
facility: Towson University
state: Maryland
Study officials:
References:
Clinical trial NCT03864718: Photodynamic Therapy in Anal Fistula
Official title: Efficacy of Photodynamic Therapy and Intra-lesional 5-wing in Complex Perianal Fistula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Fistula
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2019-03-06
Enrollment: 49
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: primary care clinic

Brief summary: Objective: Validate and analyze the results of intralesional photodynamic therapy in the treatment of complex anal fistula.

Methods: Prospective observational study including patients treated for complex anal fistula who underwent intralesional photodynamic therapy (i-PDT). Patients were included with a minimum follow up of 1-year, in order to evaluate recurrence, continence and postoperative morbidity. Intralesional 5-aminolevulinic acid gel 2% was directly injected into the fistula. The internal and external orifices were closed. After an incubation period of 2 h, the fistula was irradiated using an optical fibre connected to a red laser (MULTIDIODE 630 PDT, INTERmedic, Spain) operating at 1 W/ cm for 3 min (180 Joules).


Eligibility criteria: Inclusion Criteria:

* complex anal fistula according to Parks classification

Exclusion Criteria:

* Non cryptoglandular fistulas
* acute sepsis
* inflammatory bowel diseases
* simple fistulas (defined as subcutaneous, intersphincteric and low transsphincteric fistula)
* pregnant patients
* ASA IV
* patients \<18
* immunocompromised
* patients who refused consent.

Primary outcomes:
measure: Healing
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02436018: WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
Official title: Safety and Efficacy Evaluation of The Nasopharyngeal Airway Embedded With Jet Ventilation Catheter(WEI NASAL JET) Applied for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peptic Ulcer
Gastric Cancer
Esophagus Cancer
Oesophagitis
Hypoxia
Keywords: Sedation
Low pulse oximetry
Upper gastrointestinal endoscopy
WEI NASAL JET
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Pudong New Area People's Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
First posted: 2015-05-06
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.


Eligibility criteria: Inclusion Criteria:

* patients undergoing upper gastrointestinal endoscopy
* age over 18 years old
* Signed informed consent form

Exclusion Criteria:

* a blood coagulation dysfunction or have a tendency of nose bleeding
* a clear diagnosis of heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
* a clear diagnosis of lung disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer)
* pregnant
* liver disease
* kidney disease
* increase in intracranial pressure
* emergency operation
* multiple trauma
* American Society of Anesthesiologists (ASA) Physical Status classification above IV
* with mouth, nose and throat infection

Primary outcomes:
measure: Low pulse oximetry incidence
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Secondary outcomes:
measure: Other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji hospital, School of Medicine, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Pudong New Area People's Hospital
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University
name: Diansan Su, Dr.
role: STUDY_CHAIR
References:
citation: Qin Y, Li LZ, Zhang XQ, Wei Y, Wang YL, Wei HF, Wang XR, Yu WF, Su DS. Supraglottic jet oxygenation and ventilation enhances oxygenation during upper gastrointestinal endoscopy in patients sedated with propofol: a randomized multicentre clinical trial. Br J Anaesth. 2017 Jul 1;119(1):158-166. doi: 10.1093/bja/aex091.
Clinical trial NCT05491018: Performance for French Pediatric Intensive Care Units
Official title: Creation of a Composite Indicator of Clinical and Economic Performance for French Pediatric Intensive Care Units
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Severity of Illness Index
Keywords: Pediatric
intensive care
Severity of Illness
economic
scoring system
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2022-08-08
Enrollment: 13270
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP)

Brief summary: Introduction. The measurement of severity scores in adult and pediatric resuscitation provides a tool for evaluating the clinical performance of resuscitation services. No pediatric studies have investigated the association between current procedure and diagnostic cost indices with pediatric ICU patient severity and mortality.

Objectives. The main objective of this project in real-life situations, in 14 French pediatric intensive care units, is to validate the recently available PIM3 and PRISM IV severity scores, which take into account the clinical dimension of performance in pediatric intensive care.

This project is a French multicenter prospective observational research project involving 14 French pediatric intensive care units belonging to the Groupe Francophone de Réanimation et Urgences Pédiatriques (GFRUP). All patients under 18 years of age admitted to the 14 pediatric intensive care units affiliated with the GFRUP and voluntarily participating in the project will be included in the study.

Expected outcomes are: Validation of PIM3 and PRISM IV scores in a French population to assess clinical performance. To develop a predictive model of mortality and a predictive model of cost in French pediatric intensive care units.


Eligibility criteria: Inclusion Criteria:

* All patients under 18 years of age admitted to the 14 pediatric intensive care units and voluntarily participating in the project will be included in the study.

Exclusion Criteria:

- Children of age of reason or parents/legal guardians of children refusing participation in this project will be excluded from the study.

Primary outcomes:
measure: Survival : yes / no
timeFrame: At PICU discharge,through study completion, an average of 2 years
Secondary outcomes:
measure: cost of PICU stay
timeFrame: At PICU discharge,through study completion, an average of 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Lille
name: Stéphane Leteurtre, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01019018: Efficacy of Subtenon's Block With Olive Tipped Cannula
Official title: Efficacy of Subtenon Anesthesia With Olive Tipped Cannula: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Keywords: subtenon block
Lead sponsor: King Khaled Eye Specialist Hospital
Sponsor class: OTHER_GOV
First posted: 2009-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing cataract extraction procedure under local anesthesia

Exclusion Criteria:

* Patients allergic to local anesthetic solutions.
* Presence local sepsis,
* Previous retinal or strabismus surgery in the same eye.
* Orbital abnormalities
* Previous subtenon's block in the same quadrant.

Primary outcomes:
measure: Measurement of Akinesia score
timeFrame: 10 minutes after the block
Secondary outcomes:
measure: Surgeon satisfactions score
timeFrame: At the end of the procedure
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: king Khaled Eye Specialist hospital
Study officials:
References:
Clinical trial NCT00749918: Effect of Vitamin D Deficiency and Vitamin D Supplementation on Glucose Metabolism
Official title: Improved Insulin Sensitivity With Therapeutic Vitamin D Replacement in Pre-Diabetic Vitamin D Deficient Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Vitamin D Deficiency
Keywords: vitamin D
Cholecalciferol
Insulin sensitivity
MinMod Millennium
FSIGT
modified frequently sampled IV glucose tolerance test
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Hennepin Healthcare Research Institute
First posted: 2008-09-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study was intended to evaluate the effect of vitamin D supplementation on insulin sensitivity and pancreatic islet beta-cell function. Our hypothesis was that vitamin D supplementation to normal levels in patients with impaired fasting glucose will result in improved insulin sensitivity and improved beta cell function.

Detailed description: A modified frequently sampled intravenous glucose tolerance (mFSIGT) test was used. On day 0, baseline 22 time point mFSIGT was performed. Subjects were then treated with cholecalciferol (vitamin D3) supplementation - 10,000 IU/day - for 28 consecutive days. mFSIGT was then repeated measuring glucose, insulin and c-peptide at all time points. 25-OH vitamin D, PTH, and calcium were also measured at time point 0 pre and post vitamin D supplementation. Data was analyzed using the Bergman/Boston minimal model for insulin homeostasis with MinMod Millennium software.

Eligibility criteria: Inclusion Criteria:

* Impaired fasting glucose
* Adult, age between 18 and 65
* Serum vitamin D level below 30 ng/mL

Exclusion Criteria:

* History of nephrolithiasis
* Any medications that can effect insulin sensitivity or beta cell function (i.e. antipsychotics, metformin)
* Pregnancy
* Liver disease
* Renal disease

Primary outcomes:
measure: Assessment of insulin sensitivity before and after oral vitamin D3 supplementation with 10,000 IU/day for one month.
timeFrame: At baseline and after 4 weeks of vitamin D supplementation
Secondary outcomes:
measure: Monitor effect of vitamin D supplementation with 10,000 IU/day for one month on serum calcium and parathyroid hormone levels.
timeFrame: One month
measure: Assess effect of vitamin D supplementation on beta cell function as measured by analysis of data collected through a modified FSIGT test.
timeFrame: One month
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota, Division of Endocrinology
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Cary Mariash, MD
role: STUDY_DIRECTOR
affiliation: University of Minnesota
name: Shaban Nazarian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Sidney Jones, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00200018: Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
Official title: ASSIST: Appetite Suppression Induced by Stimulation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe to Morbid Obesity and Type 2 Diabetes
Keywords: Obesity
Morbid obesity
Diabetes
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
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 test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes with HbA1c of 7.5 - 11%
* Willing to make behavior and lifestyle modifications
* No previous bariatric surgery (gastric bypass, gastric banding)
* Meet additional study criteria

Exclusion Criteria:

* History of substance abuse or chemical dependency with in the last 3 years
* Prior GI surgery for morbid obesity or any gastric surgery for conditions other than obesity or diabetes
* Severe congestive heart failure
* Any underlying illness other than diabetes or obesity that affects gastrointestinal motility
* Currently taking medications for weight loss

Primary outcomes:
measure: Mean excess weight loss and percent excess weight loss
timeFrame: 12 months
Secondary outcomes:
measure: Diabetes status and use of diabetes medication
timeFrame: 12 months
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Eagan
country: United States
state: Minnesota
Study officials:
affiliation: Medtronic
name: ASSIST Team
role: STUDY_CHAIR
References:
Clinical trial NCT00046618: Mapping Novel Disease Genes for Dilated Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy, Congestive
Cardiovascular Diseases
Heart Diseases
Heart Failure, Congestive
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2002-10-01
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To identify new dilated cardiomyopathy genes by genetic linkage and mutational analyses.

Detailed description: BACKGROUND:

Dilated cardiomyopathy (DCM) is a heritable, genetically heterogeneous disorder causing congestive heart failure. Current medical therapy has minimal impact on prognosis and cardiac transplantation is the only definitive treatment for end-stage disease. The molecular and cellular mechanisms underlying DCM are poorly defined, but the importance of single gene defects in disease pathogenesis is becoming increasingly apparent.

DESIGN NARRATIVE:

The genetic epidemiology study will identify novel dilated cardiomyopathy genes using genetic linkage and mutational analyses. The first aim is to determine the chromosomal location of novel familial dilated cardiomyopathy genes. This will be accomplished by genome-wide genotyping and genetic linkage analyses in three large families with autosomal dominant dilated cardiomyopathy. Previously identified dilated cardiomyopathy genes have been excluded in these families. The second aim is to identify mutations in novel genes that cause familial dilated cardiomyopathy by linkage and sequence analyses of candidate genes mapping to dilated cardiomyopathy loci. Once novel genes for familial dilated cardiomyopathy are identified, the third aim will be to determine the role of these genes in a large cohort of unrelated patients with familial and sporadic dilated cardiomyopathy. High throughput DNA sequence analyses will be performed to identify additional inherited and de novo mutations.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Timothy Olson
References:
citation: Olson TM, Michels VV, Ballew JD, Reyna SP, Karst ML, Herron KJ, Horton SC, Rodeheffer RJ, Anderson JL. Sodium channel mutations and susceptibility to heart failure and atrial fibrillation. JAMA. 2005 Jan 26;293(4):447-54. doi: 10.1001/jama.293.4.447.