louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03120039: Measuring Upper Extremity Functional Movement with Accelerometry: FitBit® Vs Actigraph®
Official title: Measuring Upper Extremity Functional Movement with Accelerometry: FitBit Vs Actigraph
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Motor Activity
Lead sponsor: Rowe, Veronica, M.D.
Sponsor class: INDIV
First posted: 2017-04-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: To determine the criterion validity of the FitBit® Flex™ compared to the ActiGraph's Bluetooth® Smart wGT3X-BT wireless activity monitor, and contribute to the clinical utility of accelerometry measurement of UE movement.

Detailed description: Participants will wear two different accelerometers (FitBit and Actigraph) to record normal, everyday movement. Data from each accelerometer will be compared to determine similarity.

Eligibility criteria: Inclusion Criteria:

* Healthy adults with no upper extremity limitations

Exclusion Criteria:

* Upper extremity limitations

Primary outcomes:
measure: Steps
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02210039: Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe
Official title: Pilot Study to Image the Esophagus Using a SECM Probe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Esophagus
Keywords: SECM
Esophagus
Imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).

Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.

Detailed description: Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.

Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).

Eligibility criteria: Inclusion Criteria:

* A previous diagnosis of Barrett's Esophagus
* Patients must be over the age of 18
* Patient must be able to give informed consent

Exclusion Criteria:

* Subjects with any history of intestinal strictures
* OR subjects with a history of prior GI surgery
* OR subjects with a history of intestinal Crohn's disease.

Primary outcomes:
measure: Number of Participants With Tolerability of the Procedure
timeFrame: During the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04760639: COVID Breath Test - Ancon
Official title: Breath Test Feasibility Trial for COVID-19 Infection Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 100
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: The study population will consist of particpants who are receiving Covid-19 testing, as well as in-patient and out-patients with Covid-19.

Brief summary: This study is designed to look at the effectiveness of a new technology call Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients. Participation in this study is expected to take less than one month and will consist of a breath sample being taken by the research team, a cheek swab being taken by the research team, a questionnaire that will be completed by the participant with the help of the research teams, and a review of your medical record.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* Patients that present for COVID-19 testing, have tested Covid negative, or Covid Positive patients.

Exclusion Criteria:

* Unable to consent
* Patients on a ventilator
* Pregnant Women

Primary outcomes:
measure: Provide an adequate sample and compare the signals given from the two groups.
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
Clinical trial NCT04998539: Effect of Travel Direction, Body Position and Technique on the Ease of Getting an Occupied Wheelchair Over a Soft Surface
Official title: Effect of Travel Direction, Body Position and Technique on the Ease of a Caregiver Getting an Occupied Wheelchair Over a Soft Surface: a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wheelchairs
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
First posted: 2021-08-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study consists of a randomized crossover trial with within-participant comparisons.
Primary purpose: OTHER

Brief summary: Wheelchair skills training is an important step in the wheelchair provision process. Caregivers play an important role in the lives of wheelchair users but very little is known about wheelchair skills training for caregivers. The goal of the study is to understand the effect of wheelchair travel direction, wheelchair occupant body position and technique used by caregivers on the ease of getting an occupied wheelchair over a soft surface.

Detailed description: Able bodied participants will be used to simulate caregivers and wheelchair occupants. Participants simulating caregivers will be asked to move the occupied wheelchair over a 5 m soft surface. Participants will be randomly assigned a direction to move the wheelchair (forward or backwards), wheelchair occupant body position (upright or leaning forward) and technique in moving the wheelchair (upright with all 4 wheels on ground or in a wheelie position with the wheelchair tipped backwards and balanced on the rear wheels). The ease of getting the occupied wheelchair over the soft surface will be evaluated by the amount of time taken to complete the task, how well the participant completed the task and the ease of performing the task as evaluated by the participant.

Eligibility criteria: Inclusion Criteria:

* able to communicate in English,
* alert, cooperative, and competent to provide informed consent,
* willing to participate (as evidenced by attending the single data-collection session), and
* have no physical impairments that would prevent their being able to push and pull a wheelchair over a soft surface

Exclusion Criteria:

* have unstable medical conditions that might make the handling of a manual wheelchair dangerous, or emotional problems that might make participation unsafe or unpleasant.

Primary outcomes:
measure: Time taken to perform task
timeFrame: through study completion , an average of 1 hour
Secondary outcomes:
measure: Ability to perform task
timeFrame: through study completion , an average of 1 hour
measure: Ease of performing the task
timeFrame: through study completion , an average of 1 hour
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Rehabilitation and Arthritis Centre
state: Nova Scotia
Study officials:
References:
Clinical trial NCT04765839: Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With COVID-19 Vaccine Messages to Minority Populations
Official title: Community-Engaged Bidirectional Pandemic Crisis and Emergency Risk Communication With Minority Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Preventable Disease
Keywords: hesitancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 101
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A cluster randomized trial will be conducted prior to widespread vaccine availability to the general public. Community-informed COVID-19 vaccine messages will be disseminated to participants. At baseline, 2 weeks and 4 weeks, the study team will survey participants to assess knowledge and attitudes about COVID-19 vaccines, including intention to be vaccinated.

Detailed description: A cluster randomized trial with 80 participants from the social networks of 8 CLs will be conducted prior to widespread vaccine availability to the general public. Four CLs and social networks (cluster of 10 per network) will be randomly assigned to receive the intervention immediately or after a delay of 2 weeks. Intervention participants will be invited to a closed social media group on the platform of their choice. CLs, selected for trustworthiness within vulnerable populations, will disseminate community-informed COVID-19 vaccine messages to members of their social networks and engage in bidirectional communication with CEnR partners to refine messages. At baseline, 2 weeks and 4 weeks, participants will be surveyed to assess knowledge and attitudes about COVID-19 vaccines, including intention to be vaccinated.

Eligibility criteria: Inclusion Criteria:

* Self-identification within a CLs social network
* Age 18 or greater
* Functional internet access.

Exclusion Criteria:

* Does not self-identify within a CLs social network
* Is under the age of 18
* Does not have functional internet access.

Primary outcomes:
measure: COVID-19 attitudes
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Mark
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04518839: The Comparison of Cognition, Depression and Anxiety, and Quality of Life After Hip Fracture Surgery Under General or Regional Anesthesia
Official title: The Comparison of Cognitive Function, Symptoms of Depression and Anxiety, and Quality of Life in Patients After Hip Fracture Surgery Under General or Regional Anesthesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Hip Fractures
Depression, Anxiety
Quality of Life
Keywords: hip fracture surgery
regional anaesthesia
general anaesthesia
postoperative cognitive dysfunction
depression
anxiety
quality of life
Lead sponsor: University of Zagreb
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical treatment of hip fractures in Clinical Hospital Center Zagreb.

Brief summary: Postoperative cognitive dysfunction is a relatively common in elderly patients after hip surgery, but exact mechanism of its onset is still unclear as well as contributing factors. There is also increased incidence of depression and anxiety. Both affect the recovery after surgery, slow it down and reduce the quality of life. Patients will be divided into two groups, operated under regional anaesthesia and operated under general anaesthesia, and monitored after surgery. Patients will be tested before and after surgery to evaluate postoperative cognitive deficits, depression and anxiety scale and health-related quality of life questionnaire.


Eligibility criteria: Inclusion Criteria:

* Patients intended for surgical treatment of hip fractures ≥ 60 years
* Patients who are category ASA I to ASA III will be included in research
* Sufficient cognitive ability
* Only those patients who have agreed to be participants in the research and have signed the consent for participation and informed consent.

Exclusion Criteria:

* Patients who refused to participate in the survey and who did not sign informed consent
* Patients with ASA IV or more
* Patients under 60 years
* Severe psychiatric disorders involving the use of psychopharmaceuticals back three months
* All patients who have other fractures in addition to hip fractures
* Polytrauma
* All patients scheduled for more than one surgical intervention during the procedure, or within the next 8 weeks
* Patients who have been diagnosed with dementia, and / or are receiving anti-dementia drugs

Primary outcomes:
measure: change in cognition
timeFrame: preoperatively/postoperative follow up 2 months
measure: change in anxiety and depression
timeFrame: preoperatively/postoperative follow up 2 months
measure: change in quality of life
timeFrame: preoperatively/postoperative follow up 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Zagreb
name: Tea Fabijanić, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05158439: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Tourette Syndrome
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Tourette Syndrome
Keywords: Tourette Syndrome
stem cell treatment
Lead sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Tourette Syndrome

Detailed description: This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Tourette Syndrome. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Tourette Syndrome
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur

Primary outcomes:
measure: Safety (adverse events)
timeFrame: Four year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: St. John's
country: Antigua and Barbuda
facility: Medical Surgical Associates Center
Study officials:
affiliation: The Foundation for Orthopaedics and Regenerative Medicine
name: Chadwick Prodromos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03344939: Impact of Parent's Presence in Neonatology
Official title: Impact of Parent's Presence in Neonatology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborn; Vitality
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 38
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: every newborn baby hospitalized in neonatology yard

Brief summary: Every year 75000 new-born babies are hospitalized in neonatology yard in France with about 60000 born prematurely.

Studies showed that parents presence is good for the baby development , decrease the stress due to hospitalization.It's also efficient for the attachment between the baby and parents.

Although the team try to settle a good atmosphere to establish this link and let parents take their position,it seems that the time taken to stay with the baby is less moreover the night.

The aim of the study is to evaluate the time of presence to find tools to increase this time in the neonatotology yard


Eligibility criteria: Inclusion Criteria:

* every newborn baby hospitalized in neonatology yard

Exclusion Criteria:

* no french speaking parents
* duration of hospitalization less than 1 week.

Primary outcomes:
measure: number of hours spent with the newborn baby the night.
timeFrame: Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
References:
Clinical trial NCT00711139: Long-term Safety and Tolerability of AFFITOPE AD01
Official title: Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer
Morbus Alzheimer
Alzheimer Vaccine
Vaccine
AD
A-beta immunotherapy
Lead sponsor: Affiris AG
Sponsor class: INDUSTRY
First posted: 2008-07-08
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects having participated in AFFiRiS 001, as AFFiRiS 003 is a follow-up trial.

Brief summary: The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001


Eligibility criteria: Inclusion Criteria:

* Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver
* Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01
* Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits.

Exclusion Criteria:

* Patients having received no vaccination with AFFITOPE AD01
* Contraindication for MRI imaging
* History of questionable compliance to visit schedule, patients not expected to complete the clinical trial

Primary outcomes:
measure: Tolerability
timeFrame: 1 year
Secondary outcomes:
measure: Immunological and clinical efficacy (evaluated in an explorative manner only)
timeFrame: 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Clinical Pharmacology, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Markus Mueller, Univ. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03282539: Lumen Apposing Metal Stents With and Without a Double Pigtail Stent in Pancreatic Collections
Official title: Lumen Apposing Metal Stents With and Without a Coaxial Double Pigtail Stent in the Management of Pancreatic Fluid Collections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Collection
Keywords: Lumen apposing metal stents
Double pigtail stents
Endoscopic ultrasonography
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 37
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: Patients wiht pancreatic fluid collections and indication for EUS-guided transmural drainage in accordance l wiht international creteria.

Brief summary: The study evaluates the security of LAMS with ando without a coaxial double pigtail plastic stent in the management of pancreatic fuid collections.

Detailed description: The introduction of lumen-apposing metal stents (LAMS) represented a great improvement in the EUS-guided transmural drainage of pancreatic fluid collections (PFCs). It is postulated safer than other types of stents due to the presence of bilateral anchoring flanges, designed to appose the stomach or duodenum to the PFC wall minimizing the risk of perforation or peritoneal leakage. In addition, the larger lumen diameter facilitates the drainage of PFC, specially the walled-off pancreatic necrosis (WOPN). However, secondary adverse effects such as infection due to complete or partial stent obstruction, migration, bleeding or buried LAMS syndrome have also been related . The placement of a coaxial double pigtail plastic within the LAMS has been reported beneficial in order to avoid external migration or the lumen obstruction and to the prevention of bleeding and other adverse events. The aim of this study was to evaluate the efficacy and safety of LAMS with and without a coaxial double pigtail plastic stent in the EUS-guided transmural drainage of PFCs.

Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic fluid collections and indication of drainage.
* EUS-guided trasmural drainage wiht lumen apposing metal stents.
* Criteria for drainage were as specified by the Working Group of the International Association of Pancreatology.

Exclusion Criteria:

* Other types of collections and stents
* Severe coagulopathy (protombin time \> 1,5) or thrombocytopenia (platelet count \< 50 x 109/L)
* PFCs with a previous attempt failed of EUS-guided transmural drainage
* Age younger than 18 years

Primary outcomes:
measure: Adverse events
timeFrame: Outcomes will be assessed 6 months after the inclusion of last patient.
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
affiliation: Hospital Universitari de Bellvitge
name: Joan Gornals
role: PRINCIPAL_INVESTIGATOR
References: