louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04541238: Imaging Template for Reporting Anal Fistula
Official title: Imaging Template for Reporting Anal Fistula
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal Fistula
Lead sponsor: Treviso Regional Hospital
Sponsor class: NETWORK
First posted: 2020-09-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 100 MRI investigations for anal fistula.

Brief summary: Magnetic resonance imaging (MRI) is the most used diagnostic tool for pre-operative assessment of anal fistula.

However, there is lack of standardization in reporting this investigation. Moreover, reports may miss a number of key information for surgical planning.

The aim of this study is to assess the effectiveness, reproducibility, and acceptability of a new template for reporting anal fistula, which may favor standardization in clinical practice and inform surgical decision making.


Eligibility criteria: Inclusion Criteria:

* Adults with primary anal fistula (cryptoglandular or Crohn-related) undergoing MRI

Exclusion Criteria:

* Active cancer of the anorectum
* Recto-vaginal fistula

Primary outcomes:
measure: Effectiveness of the novel template compared to standard reporting based on the number of key descriptors
timeFrame: 60 days
Secondary outcomes:
measure: Inter-rater agreement between two independent experienced radiologists using the novel template
timeFrame: 7 days
measure: Qualitative analysis
timeFrame: 30 days
Other outcomes:
Locations:
city: Treviso
country: Italy
facility: Treviso Regional Hospital
Study officials:
affiliation: Treviso Regional Hospital, University of Padua
name: Ugo Grossi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sudol-Szopinska I, Santoro GA, Kolodziejczak M, Wiaczek A, Grossi U. Magnetic resonance imaging template to standardize reporting of anal fistulas. Tech Coloproctol. 2021 Mar;25(3):333-337. doi: 10.1007/s10151-020-02384-6. Epub 2021 Jan 5.
Clinical trial NCT06660238: PET-CT to Assess Brain Damage in Cardiac Arrest Patients
Official title: Assessment of Cerebral Metabolism, Cerebral Blood Flow and Cerebral Oxygen Damage in Patients With Cardiac Arrest Using PET-CT
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cardiac Arrest
Brain Injuries
Keywords: Cardiac arrest
Positron Emission Tomography-Computed Tomography
cerebral metabolism
cerebral blood flow
cerebral oxygenation
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.

Brief summary: This was a single-center, observational study. Patients with successful cardiopulmonary resuscitation (CPR) will be transferred to the emergency intensive care unit for further standardized management. After successful return of spontaneous circulation (ROSC) for 72 hours and hemodynamic stability for 24 hours, the patients underwent positron emission computed tomography (PET-CT) examination after resuscitation. The supervising physician accompanied the patient and used monitors to monitor vital signs during the examination. Patients who were on ventilators were mechanically ventilated with a magnetic ventilator (HAMILTON-MRI, United States). In addition to conventional cerebral oxygen metabolism, cerebral blood flow, oxygen extraction fraction, cerebral blood volume and other indicators were added in this experiment. These indicators can evaluate the patient's cerebral metabolism, cerebral blood flow and cerebral blood oxygen damage degree. The neurological outcome was followed up 6 months after onset according to the cerebral performance category（CPC）.


Eligibility criteria: Inclusion Criteria:

* age ≥18 years.
* sustained hemodynamic stability for ≥24h.
* the patients were unconscious and not able to obey verbal commands. • Advanced life support and target temperature management within 6 hours of return of spontaneous circulation (ROSC).

Exclusion Criteria:

* Patients with hemodynamic instability.
* Patients who could not complete cranial PET-CT examination for special reasons. • Patients during pregnancy.
* Patients who combined traumatic brain injury, stroke, cerebral hemorrhage and other diseases.
* Patients whose family members did not agree to be enrolled.

Primary outcomes:
measure: Neurologic prognosis
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing chaoyang hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06345638: Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease
Official title: Sex Hormones and Inflammatory Biomarkers in Patients With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sickle Cell Disease
Vaso-occlusive Crisis
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individual with sickle cell disease receiving care for vaso-occlusive pain episodes.

Brief summary: This study aims to characterize sex differences in the pathophysiology of vaso-occlusive crises (VOC) occurring among individuals with sickle cell disease (SCD).

* The study will compare CRP and other biomarkers between females with SCD in the follicular phase of the menstrual cycle and males with SCD.
* The study will explore potential sex differences in biomarker changes between females and males with SCD during and following resolution of VOC.
* The study will compare neutrophil and platelet adhesion to the endothelium and real time fibrin deposition in the blood.


Eligibility criteria: Inclusion Criteria:

* Adult males and females aged 18-45
* Diagnosis of sickle cell disease
* current hospitalization for vaso-occlusive pain episode or current outpatient infusion at the recruiting sites
* Able to read and understand English
* Willing to comply with study procedures

Exclusion Criteria:

* Currently pregnant, pregnant within the last month, or seeking to become pregnant

Primary outcomes:
measure: C-reactive protein level
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine University City
state: Pennsylvania
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05443438: Where's the Wif? Referent Selection and Retention
Official title: Technological Timescales: Identifying the Impact of Digital Media on the Mechanisms of Word Learning. Aim 1: Where's the Wif? Referent Selection and Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-07-05
Enrollment: 212
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of for conditions.
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this work is to address increasing concerns about young children's digital media exposure and language outcomes by testing how the times course of word learning unfolds in digital environments and the cascading impact of digital media on vocabulary outcomes. The findings will have important implications for understanding when and where optimal word learning from media can occur.

Detailed description: The goal of the current proposal is to identify how digital media alters the mechanisms of word learning and subsequently impacts the lexical foundation on which a child's vocabulary is built. Specifically, the proposal aims to identify the impact of digital media on 1) the processes underlying real-time word learning, and 2) the processes of language generalization and vocabulary growth. Specific Aim 1 will use a novel word learning task to test children's ability to map and retain new words within and between digital media (2D images on a tablet) and real world objects (3D objects). Specific Aim 2 will probe children's novel label generalization abilities within and between 2D and 3D modalities using a novel noun generalization task. Further, individual differences in a child's prior technology experience will be measured and used to predict overall vocabulary as well as performance within and between each task. This Clinical Trial record is focused on Specific Aim 1.

Eligibility criteria: Inclusion Criteria:

* between 18 and 30 months old

Exclusion Criteria:

* diagnosed developmental delay or disorder
* exposure to more than 25% of another language

Primary outcomes:
measure: Accuracy on Referent Selection
timeFrame: 1 minute
measure: Accuracy on Retention
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Oklahoma State University
state: Oklahoma
Study officials:
References:
Clinical trial NCT00983203: Acute Comfort and Haze Profile of FID 114657
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Dry eye
artificial tears
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to describe the acute comfort and haze profile of FID 114657 in dry eye patients.


Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of dry eye

Exclusion Criteria:

* Must not have worn contact lenses for 1 week preceding enrollment

Primary outcomes:
measure: Drop comfort upon instillation
timeFrame: Upon instillation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01529203: Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Official title: Subjects' Satisfaction on Pan Facial Aesthetic Enhancement After Treatment With Azzalure® and the Restylane® Range
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aging
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of this study is to assess subjects' satisfaction linked to the pan facial management of rejuvenation with injections of Azzalure® and Restylane® fillers.

This will be an open, multi-centre study.


Eligibility criteria: Main Inclusion Criteria:

* Male or female subjects, aged 18 to 64 years, seeking treatment for correction of dynamic wrinkles of the upper third of the face and correction of facial volume loss, and meeting other specific eligibility criteria

Main Exclusion Criteria:

* Female subject who is pregnant, nursing or planning a pregnancy during the study
* Subject with any contraindications to the injection of hyaluronic acid (see package inserts)
* Subject with any contraindications to the injection of botulinum toxin (see package insert)
* Subject with a personal history of allergic/anaphylactic reactions including hypersensitivity to crossed-linked hyaluronic acid or botulinum toxin
* Concurrent treatment that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of at least one of the study treatments
* Subject with a history of dissatisfaction with facial aesthetic procedures involving dermal implant injections or subject with unattainable expectations
* Subject currently enrolled in another investigational study or who participated in such a study in the past 30 days prior to baseline visit

Primary outcomes:
measure: Subject Satisfaction for the Full Face
timeFrame: Month 6
Secondary outcomes:
measure: Global Aesthetic Improvement From Baseline
timeFrame: Week 3
measure: Related Adverse Event
timeFrame: Month 6
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Galderma investigational site
city: Metz
country: France
facility: Galderma investigational site
city: Madrid
country: Spain
facility: Galderma investigational site
city: London
country: United Kingdom
facility: Galderma investigational site
city: Street
country: United Kingdom
facility: Galderma investigational site
Study officials:
References:
Clinical trial NCT00305903: Safety and Tolerability of Rivastigmine With Add-on Memantine in Patients With Probable Alzheimer's Disease
Official title: A Prospective, 26-Week, Open-Label, Multi-Center, Single-Arm Pilot Study to Evaluate the Safety and Tolerability of Rivastigmine Capsule With Add on Memantine HCl in Patients With Probable Alzheimer's Disease (MMSE 10-20)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Dementia,
Alzheimer's,
Rivastigmine,
Memantine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, 26-week, open-label, single-arm multi-center pilot study. Eligible patients will receive open-label treatment with rivastigmine capsules plus memantine tablets as add on therapy. This study is designed to evaluate the safety and tolerability of add on therapy with memantine to rivastigmine capsules in patients with probable AD (MMSE 10-20)


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of probable Alzheimer's disease;
* Have an MMSE score between 10 and 20;
* Must be able to swallow capsule/tablet;
* Must have a caregiver who is able to attend all study visits;

Exclusion Criteria:

* Have an advanced, severe, progressive, or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient at special risk;
* Have a current diagnosis of active, uncontrolled seizure disorder;
* Have a history within the past year or current diagnosis of cerebrovascular disease
* Have a current diagnosis of severe or unstable cardiovascular disease;
* Had a myocardial infarction (MI) within the last six months;
* Have specific respiratory, digestive, renal, or endocrine disorders;
* Have had previous treatment with rivastigmine or memantine;

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Safety and tolerability of treatment with memantine and rivastigmine, measured by the incidence of GI adverse events (nausea and vomiting)
Secondary outcomes:
measure: Whether patients on rivastigmine and memantine are able to reach and maintain higher doses of rivastigmine compared to historical data of rivastigmine monotherapy
Other outcomes:
Locations:
city: Manchester
country: United States
state: New Jersey
Study officials:
affiliation: 862-778-8300
name: Novartis
role: STUDY_CHAIR
References:
citation: Sadowsky CH, Dengiz A, Meng X, Olin JT; US38 Study Group. Switching from oral donepezil to rivastigmine transdermal patch in Alzheimer's disease: 20-week extension phase results. Prim Care Companion J Clin Psychiatry. 2010;12(5):PCC.09m00852. doi: 10.4088/PCC.09m00852oli.
Clinical trial NCT04736303: The Impact of the Implementation of BIS on the Incidence of Postoperative Delirium
Official title: Assessing the Impact of the Implementation of BIS on the Incidence of Postoperative Delirium - A Monocentre Prospective Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Delirium
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 1400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will investigate the incidence of postoperative POD in patients undergoing non cardiac surgery under general anesthesia with and without the implementation of the BIS monitoring.T

Detailed description: This study will compare the incidence of POD after elective non cardiac surgery conducted under general anesthesia before and after the implementation of BIS monitoring in our University Hospital.

The POD will be evaluated with the CAM and Nu-DESC tools, which have been adapted for the greek population.

Eligibility criteria: Inclusion Criteria:

1. adult patients over 60 years of age
2. an American Society of Anesthesiologists (ASA) physical status I to III
3. undergoing elective non cardiac surgery under general anaesthesia
4. native speakers of the Greek language
5. eligible to leave the post-anaesthesia care unit
6. an expected in-hospital stay at least 24 hours following surgery

Exclusion Criteria:

1. refused to participate or sign the informed consent form
2. surgery or anaesthesia within the last 30 day
3. any prior or current history involving an affliction of the central nervous system
4. severe hearing or visual impairment
5. psychiatric disorders
6. a score less than 5 according the Geriatric Depression Scale (GDS-15)
7. a score less than 4 for females and less than 2 for males according to the Lawton-Brody Instrumental Activities of Daily Living Scale (I.A.D.L.)
8. alcohol consumption less than 35 units/week
9. drug dependence
10. previous neuropsychological testing
11. haemodynamical instability
12. peri-procedural desaturation (one or more events of SpO2\<80% for more than 2 minutes)

Primary outcomes:
measure: Incidence of POD
timeFrame: 1st postoperative day
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Univeristy of Thessaly
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutoglou, MD, PhD
role: STUDY_CHAIR
affiliation: University Hospital of Larissa
name: Maria Ntalouka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269003: Responses to Message Source and Presentation Using Psychophysiology
Official title: Identifying and Examining the Effects of Source and Presentation on Responses to Electronic Cigarette Public Education Messages in Young Adult Vapers and Non-vapers - Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-02-21
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.


Eligibility criteria: Inclusion Criteria:

* Ages 18-24
* Fluent in English
* Either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping
* Self-reported abstinence of combusted tobacco or marijuana at time of visit

Exclusion Criteria:

* Ages below 18 or above 24
* Not fluent in English
* Not confirmed self-reported abstinence of combusted tobacco or marijuana at time of visit

Primary outcomes:
measure: Visual attention
timeFrame: 45 minutes
measure: Orienting response
timeFrame: 45 minutes
measure: Arousal
timeFrame: 45 minutes
Secondary outcomes:
measure: Attitudes
timeFrame: 45 minutes
measure: Behavioral intentions
timeFrame: 45 minutes
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Chan Medical School Shaw Building
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Donghee N Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04628403: Effects of Clinical Interventions for the Management of Late Start
Official title: Effects of Clinical Interventions for the Management of Late Start Muscular Pain (Doms) in the Post-exercise Recovery Process
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Athletes
Keywords: Lasertherapy
Shockwaves
Massage
Sports Medicine
Athletic Performance
Lead sponsor: São Paulo State University
Sponsor class: OTHER
First posted: 2020-11-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: Late-onset muscle pain (DOMS) is characterized by a type of temporary muscle damage, common after high-intensity exercise. In addition to pain, DOMS clinically generates muscle stiffness, reduced joint range of motion, muscle weakness and reduced peak torque. In this regard, in order to accelerate the recovery of body systems and treat symptoms of DOMS, the management of different types of interventions has been observed, supporting the clinical practice, based on evidence. Objectives: To investigate the effect of different types of clinical interventions for the treatment of DOMS. Material and methods: For the clinical trial, 50 ultramarathon and rowing athletes of both sexes, aged between 18 and 60 years old, will be recruited randomly into four possible groups: control (CG), shock waves (G1) , massage (G2) and laser therapy (G3). The evaluation moments will be as follows: minutes before exercise (M1); immediately after exercise (M2); immediately after applying the recovery technique (M3); and 24 hours after exercise (M4) and the evaluated outcomes will be: pain, psychological aspects, functional test and blood markers.


Eligibility criteria: Inclusion Criteria:

* Professional athletes;
* Age over 18 years;
* Both sexes;
* Not having recent injuries

Exclusion Criteria:

* Participants who do not complete all the proposed collection moments
* who do not agree to participate will be excluded.

Primary outcomes:
measure: PAIN
timeFrame: 7 days
measure: SATISFACTION
timeFrame: 7 days
Secondary outcomes:
measure: MUSCLE STRENGTH
timeFrame: 7 days
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Federal do Estado do Rio de Janeiro
state: RJ
Study officials:
References: