louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05472727: Comparison of Physical Fitness, Walking Speed, Reaction Time In Older Adults With and Without Mild Cognitive Impairment
Official title: Comparison of Physical Fitness, Walking Speed, Reaction Time In Older Adults With and Without Mild Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reaction Time
Physical Fitness
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly people who are healthy or with mild cognitive impairment

Brief summary: The aim of the study is to compare physical fitness, walking speed and hand reaction time measurements in older adults with different cognition levels according to the Montreal Cognitive Assessment Scale (MOCA).


Eligibility criteria: Inclusion Criteria:

* Being 65 years or older
* Volunteering to participate in the study
* 10 meters independent walking
* Being diagnosed with mild cognitive dysfunction
* Not being diagnosed with cognitive dysfunction
* Having received five years of basic education

Exclusion Criteria:

* Having had an upper or lower extremity surgery in the last 6 months
* Having a health problem that prevents completing the tests in the study

Primary outcomes:
measure: reaction time
timeFrame: Participants are expected to complete the 3 sub-parameters of reaction time measurements in an average of 20 minutes, including rest periods
Secondary outcomes:
measure: physical fitness
timeFrame: Physical fitness tests are expected to take an average of 20 minutes.
Other outcomes:
Locations:
Study officials:
affiliation: iengin.simsek@gmail.com
name: Ibrahim Engin Simsek, professor
role: STUDY_CHAIR
References:
Clinical trial NCT02342327: Smoking Cessation in Menthol Flavored Cigarette Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching


Eligibility criteria: Inclusion Criteria:

* Self identify as African American
* smoke primarily menthol cigarettes
* be between the ages of 18 and 64
* smoke a minimum number of cigarettes per day
* express an interest in quitting smoking

Exclusion Criteria:

* current unstable medical / psychiatric condition
* regular use any form of nicotine or tobacco other than cigarettes
* are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not be eligible to participate

Primary outcomes:
measure: Time to Lapse
timeFrame: 6 months
Secondary outcomes:
measure: Time to Relapse
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Sciences Institute
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michael Kotlyar, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on Smoking Behavior of Switching Menthol Smokers to Non-menthol Cigarettes. Nicotine Tob Res. 2021 Oct 7;23(11):1921-1927. doi: 10.1093/ntr/ntab090.
citation: Kotlyar M, Shanley R, Dufresne SR, Corcoran GA, Okuyemi KS, Mills AM, Hatsukami DK. Effects on time to lapse of switching menthol smokers to non-menthol cigarettes prior to a cessation attempt: a pilot study. Tob Control. 2021 Sep;30(5):574-577. doi: 10.1136/tobaccocontrol-2020-055689. Epub 2020 Jul 27.
Clinical trial NCT04330027: Effectiveness of Lyophilized Growth Factors for Subacromial Impingement
Official title: Effectiveness of Lyophilized Growth Factors for Subacromial Impingement: Randomized Double Blind Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of ultrasound-guided injection of platelet-derived lyophilized growth factors in treatment of subacromial impingement.

Detailed description: A new patented product named lyophilized Growth Factors has been developed. It is a novel advanced and refined form of conventional platelet-rich plasma. Effectiveness of intra-articular lyophilized Growth Factors injection has been studied in thirty patients with symptomatic primary knee osteoarthritis and has shown encouraging results regarding improvement of pain, stiffness and function in addition to decreasing knee effusion.

The lack of good quality evidence to support the efficacy of injecting platelet-derived lyophilized growth factors in treatment of subacromial impingement highlights the need for thorough evaluation of the outcome of this novel therapeutic option in patients with subacromial impingement.

Eligibility criteria: Inclusion Criteria:

* Clinically:

  1. Anterolateral shoulder and/or lateral upper arm pain.
  2. Painful arc of motion between 70° and 120°.
  3. Positive impingement sign (Neer's test or Hawkins-Kennedy test).
* Ultrasonographically:

The elicitation of a transient arc of pain during shoulder abduction which coincides with passage of the supraspinatus insertion beneath the coraco-acromial arch.

Exclusion Criteria:

* History of shoulder surgery, fracture, dislocation or subluxation.
* Patients with full-thickness rotator cuff tear, weakness on arm elevation, or positive "drop arm sign".
* Patients who have been diagnosed with a frozen shoulder or degenerative arthropathy of the glenohumeral joint.
* Patients with disorders of the cervical spine or upper extremity that have a significant impact on the shoulder
* Patients with diabetes mellitus, rheumatoid arthritis, hypothyroidism or other painful or function limiting disorders of the shoulder.
* Significant cardiovascular, renal or hepatic disease.
* Active infection in the area to be treated.

Primary outcomes:
measure: VAS (Visual Analogue Scale)
timeFrame: 8 weeks
measure: SPADI (Shoulder Pain and Disability Index)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Hospitals
Study officials:
affiliation: Alexandria University
name: Jailan Noureldin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823627: Pulmonary Disease in a Psychiatric Inpatient Population
Official title: Pulmonary Disease in a Psychiatric Inpatient Population, a Screening Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Airway Disease
Keywords: COPD
Psychiatric inpatient
Smoking
Lead sponsor: Psykiatrien Syd
Sponsor class: OTHER
Collaborators: name: Naestved Hospital
First posted: 2013-04-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose: Patients with mental health disorders have a reduced life expectancy, compared to the general population. The shorter life expectancy is caused by natural and unnatural death. In general, patients with a mental disorder tend to have a more unhealthy lifestyle, than the general population, characterized by e.g. lack of exercise and smoking.

Hypothesis

Chronic obstructive pulmonary disease (COPD) is underdiagnosed in psychiatric inpatients There is a higher prevalence of COPD in psychiatric inpatients compared to the general population Screening of patients with one respiratory symptom and a smoking history, has the same sensitivity regarding to diagnosis of COPD, as screening all patients with a smoking history

Method:

80 psychiatric inpatients will undergo spirometry with reversibility test and COPD Assessment Test (CATest). Furthermore, patient history regarding respiratory symptoms and smoking will be taken into account.


Eligibility criteria: Inclusion Criteria:

* Inpatients in Psykiatrien Syd, Region Zealand, ward S1,S2,S3,S4,S5,S6
* Admission time over 48 hours

Exclusion Criteria:

* Patients who is not able to perform spirometry due to their psychiatric condition

Primary outcomes:
measure: Tiffeneau index
timeFrame: at enrollment
Secondary outcomes:
measure: forced vital capacity
timeFrame: at enrollment
measure: Forced expiratory volume in 1 second
timeFrame: at enrollment
Other outcomes:
Locations:
city: Vordingborg
country: Denmark
facility: Psyciatrien Syd, Region Zealand
Study officials:
affiliation: Psykiatrien Syd
name: Nicolai Renstrom
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00134927: A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches
Official title: Usage Patterns of OTC Nicotine Patches: Consumer Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nicotine Dependence
Tobacco Use Disorder
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-08-25
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 600 consumers who purchased over-the-counter nicotine patches from a random sample of 30 retail pharmacies in San Diego County

Brief summary: Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Little is known about how the public uses the OTC nicotine patch due to lack of monitoring. The purpose of this observational study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with the appropriate use of nicotine patches.

Detailed description: The nicotine patch is an effective aid for smoking cessation. Since 1996, the nicotine patch has been re-classified from prescription to over-the-counter (OTC) status in the United States. Unlike prescription medications, post-marketing surveillance does not exist for OTC medications. The purpose of this study is to describe the characteristics of consumers who purchase OTC nicotine patches from community pharmacies and to determine the factors associated with appropriate use of nicotine patches.

This prospective, cross-sectional, observational study will include a survey of 600 consumers who purchase OTC nicotine patches at a random sample of 30 community retail pharmacies. Consumers will be recruited by an ad located in the pharmacy next to the nicotine patch product. Participants will fill out a self-administered, anonymous questionnaire at the time of OTC nicotine patch purchase at the pharmacy counter. The questionnaire will gather information about demographics, medical history, smoking history, attitudes toward the nicotine patch, and motivation to quit smoking. No study visits will be required for this study.

Eligibility criteria: Inclusion Criteria:

* Purchased OTC nicotine patch (NicoDerm CQ Step I, II, III or Sav-on Nicotine Patch) for personal use

Exclusion Criteria:

* Purchased OTC nicotine patch for someone other than self (e.g., friend or family member)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Department of Family and Preventive Medicine
state: California
Study officials:
affiliation: University of California, San Diego
name: Chih-Wen Shi, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806427: Tolerance of a Calorically Dense Enteral Nutrition Formula
Official title: Tolerance of a Calorically Dense Enteral Nutrition Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enteral Feeding
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with established enteral access receiving standard tube feeding formula in the ICU

Brief summary: This prospective observational study seeks to demonstrate the ability to meet nutritional needs of a calorically dense enteral formula in critically ill patients.


Eligibility criteria: Inclusion Criteria:

* Adult aged \> 18 years
* Admitted to Medical ICU with expected admission of ≥ 3 days
* Established enteral access
* Having obtained his/her or legal representative's informed consent.

Exclusion Criteria:

* Pregnant or lactating
* Condition which contraindicates enteral feeding (i.e. intestinal obstruction)
* Lack of enteral access
* Parenteral nutrition
* Any condition that would contraindicate use of the study product (i.e. need for severe fluid restriction, cow's milk protein allergy, etc.)
* Subject who in the Investigator's assessment cannot be expected to comply with study protocol
* Currently participating in another conflicting clinical trial.

Primary outcomes:
measure: Daily percentage of caloric nutritional goal met
timeFrame: First 3 days in the ICU
Secondary outcomes:
measure: Daily percentage of protein goal met
timeFrame: First 5 days in the ICU
measure: Adverse events and serious adverse events
timeFrame: First 5 days in the ICU
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
Study officials:
affiliation: Oklahoma University Health Sciences Center
name: Karen Allen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02669927: Frailty and Postoperative Shock
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frailty
Elderly
Keywords: hip surgery
frail older people
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 53
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 53 patients (age = 82 ans \[56-98\]) hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015

Brief summary: To find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery.


Eligibility criteria: Inclusion Criteria:

* hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015

Exclusion Criteria:

* non-traumatic hip fracture
* refusal

Primary outcomes:
measure: Mortality
timeFrame: up to one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02858427: Cognitive Inhibition, Psychosocial Interactions and Suicide Attempt in Elderly
Official title: Cognitive Inhibition Impairment and Suicide Attempt in Elderly: Eye Tracking Characterization and Impact of Psychosocial Interactions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide
Keywords: cognitive inhibition
elderly
suicide attempt
depression
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: The study aims to determine the correlation between the cognitive inhibition impairment and the history of suicide attempt in elderly depressed patients.

Detailed description: 2 groups of patients will be studied: in the first group, depressed patients with a history of suicide attempt will be included whereas in the second group, depressed patients without a history of suicide attempt will be included.

For each group, the cognitive inhibition will be assessed trough an eye tracker task (antisaccade).

Both groups will also be compared on their neuropsychological characteristics and the quality of social interactions of participants.

Eligibility criteria: Inclusion Criteria:

* major depressive disorder according to Diagnostic ans Statistical Manual (DSM) V
* group 1: with a history of suicide attempt
* group 2: without a history of suicide attempt

Exclusion Criteria:

* other psychiatric disease
* guardianship

Primary outcomes:
measure: antisaccade error rate
timeFrame: 1 month max. after inclusion
Secondary outcomes:
measure: saccade accuracy
timeFrame: 1 month max. after inclusion
measure: saccadic intrusion
timeFrame: 1 month max. after inclusion
measure: maximal speed of the gaze
timeFrame: 1 month max. after inclusion
measure: saccade reaction time
timeFrame: 1 month max. after inclusion
measure: fixation duration on pictures
timeFrame: 1 month max. after inclusion
measure: social interaction quality score
timeFrame: 6 month max. after inclusion
Other outcomes:
measure: neuropsychological test score
timeFrame: 1 month max. after inclusion
Locations:
city: Besancon
country: France
facility: CHU Besancon
state: Doubs
city: Bavilliers
country: France
facility: CHS Bavilliers
Study officials:
affiliation: Centre Hospitalier Universitaire de Besancon
name: pierre vandel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05822427: Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
Official title: Long-term Follow-up of Study Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product in an Imugene Ltd. Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Participants Who Received an Allogeneic Chimeric Antigen Receptor T-Cell Product (PBCAR) in a Precision BioSciences, Inc., Clinical Study
Keywords: Allogeneic chimeric antigen receptor (CAR) T cell products
azer-cel
Lead sponsor: Imugene Limited
Sponsor class: INDUSTRY
First posted: 2023-04-20
Enrollment: 75
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: Any participant who has received a azer-cel in an Imugene clinical study can be enrolled into this LTFU study.

Brief summary: The goal of this observational study is to collect information on the long-term safety of study participants who received an Allogeneic Chimeric Antigen Receptor (CAR) T-Cell Product in an Imugene Clinical Study. The main questions it aims to answer are:

* What are the frequency, severity, duration, and outcome of clinically significant Clinical Events of Interest (CEI)?
* What is the duration of response and overall survival time after taking an allogeneic CAR T-Cell product on an Imugene clinical study?

Participants will have a yearly visit either face to face or remotely for up to 15 years to check for CEI.

Detailed description: This is a Long-Term Follow-Up (LTFU) observational study designed primarily to collect data regarding CEI for up to 15 years following participation in an Imugene clinical study for subjects who received azer-cel. This study protocol does not include administration of azer-cel; however, subjects may receive standard of care treatment or investigational products other than azer-cel through participation in other clinical studies during the period of this observational study.

Eligibility criteria: Inclusion Criteria:

* Receipt of at least 1 dose of azer-cel in an Imugene clinical study.
* A signed informed consent form (ICF).
* Willingness and ability to adhere to the study schedule and all other protocol requirements.

Exclusion Criteria:

* No unique exclusion criteria apply to this study.

Primary outcomes:
measure: Frequency of Clinically Significant Clinical Events of Interest (CEI)
timeFrame: Up to 15 years
measure: Severity of Clinically Significant CEI
timeFrame: Up to 15 years
measure: Duration of Clinically Significant CEI
timeFrame: Up to 15 years
measure: Outcome of Clinically Significant CEI
timeFrame: Up to 15 years
Secondary outcomes:
measure: Duration of Disease Response
timeFrame: Up to 15 years
measure: Overall Survival Rate
timeFrame: Up to 15 years
measure: Azer-cel Persistence
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Culver City
country: United States
facility: Science 37, Inc.
state: California
Study officials:
References:
Clinical trial NCT01325727: Brief Computerized Feedback for Smokers in Recovery
Official title: Brief Computerized Feedback for Smokers in Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2011-03-30
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to find out more about smokers in recovery from addiction to alcohol/other drugs, and to evaluate a brief computerized smoking behavior feedback session. The hypothesis is that a brief computerized smoking behavior feedback session will motivate more smokers to quit smoking than a control condition.


Eligibility criteria: Inclusion Criteria:

1. Be 18 years of age or older
2. Be in recovery from addiction to alcohol and/or drugs (self-defined)
3. Have smoked at least one cigarette per day for the past seven days or at least 10 cigarettes total during the past week
4. Have smoked at least 100 cigarettes (lifetime)
5. Have an expired air carbon monoxide (CO) level of \> 6 ppm (verifies current smoking)
6. Be cognitively able to understand the proposed research design (screening followed by random assignment to one of the two conditions, if appropriate)

To be eligible to receive NRT (if chosen by the participant), participants must:

1. Not be pregnant, breastfeeding, or plan to become pregnant in the next year
2. Not have experienced a myocardial infarction (heart attack) or have been hospitalized for a heart-related problem in the last 2 weeks

Primary outcomes:
measure: % quit smoking
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Midlothian
country: United States
facility: Substance Abuse Addiction and Recovery Alliance Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Alison Breland, PhD
role: PRINCIPAL_INVESTIGATOR
References: