louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06222554: Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients
Official title: Pilot/Feasibility Study Examining the Use of a Novel Immersive Motion Tracking Upper Extremity Exercise Program for Acute Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplant
Liver Transplant
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 12
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: The objective of this study is to evaluate the feasibility of the MoveMend Health software program as an integrated supplement to traditional acute care/in-hospital occupational therapy for patients following liver and kidney transplants, as determined by recruitment rates, program completion, intervention adherence, safety incidence, and patient feedback on device/program performance.


Eligibility criteria: Inclusion Criteria:

* English speaking (software program is currently only available in English)
* Status post kidney or liver transplant this admission
* Physician orders for occupational therapy evaluation and treatment
* Orientation Log \> 25
* Negative for delirium per the Confusion Assessment Method

Exclusion Criteria:

* Orthopedic or surgical precautions that limits shoulder range of motion beyond 90 degrees
* Upper extremity hemiplegia with inability to lift upper extremity against gravity
* Accommodation code of Intensive Care Unit

Primary outcomes:
measure: Recruitment Rate
timeFrame: Up to Month 6 Post-Operation
measure: Percentage of Participants who Complete Exercise Program
timeFrame: Up to Month 6 Post-Operation
measure: Percentage of Participants who Adhere to Intervention
timeFrame: Up to Month 6 Post-Operation
measure: Number of Adverse Events
timeFrame: Up to Month 6 Post-Operation
Secondary outcomes:
measure: Change in Activity Measure for Post-Acute Care (AMPAC) Score
timeFrame: Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
measure: Change in Grip Strength
timeFrame: Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
measure: Upper Extremity Range of Motion (ROM) Change
timeFrame: Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
measure: Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire Index Score
timeFrame: Baseline, End of Hospital Stay (typically no more than 6 months post-operation)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: John Corcoran
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05767554: Depression, Experiential Diversity, and Behavioral Novelty
Official title: Depression, Experiential Diversity, and Behavioral Novelty: A Mobile Sensing Experimental Paradigm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Behavioral activation
Mobile sensing
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test whether changes in behavioral patterns are related to changes in depression. Depression is a psychological condition that involves persistent sad mood and/or an inability to enjoy pleasurable activities. Very stable behavioral patterns may be related to symptoms of depression. The aim of this study is to learn more about the relationship between symptoms of depression and behavioral patterns that are collected via global positioning system location data from a smart phone.


Eligibility criteria: Inclusion Criteria:

* Age 18-25
* Possession and daily use of a smart phone
* Able to speak and read English
* Patient Health Questionnaire -8 (PHQ-8) \> 10
* Behavioral Activation for Depression (BADS) Activation Subscale \< 16
* Ability to complete all study procedures

Exclusion Criteria:

* Self-reported lifetime diagnosis of agoraphobia or bipolar disorder
* Severe neurodevelopmental disorder
* Major travel plans within study period

Primary outcomes:
measure: Change in Patient Health Questionnaire-8 Total Score over 5 Weeks
timeFrame: Baseline and 5 weeks
Secondary outcomes:
measure: Change in Behavioral Activation for Depression Scale over 5 Weeks
timeFrame: Baseline and 5 weeks
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin Institute of Mental Health Research
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Christopher G Beevers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564654: A Retrospective Study of the iTotal CR Knee Replacement System
Official title: A Retrospective, Multi-Center Study to Evaluate the ConforMIS iTotal® CR (Cruciate Retaining) Total Knee Replacement System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Restor3D
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received an iTotal Knee replacement

Brief summary: This study involves retrospective collection of data regarding the first approximately 100 iTotal Knee Replacement System surgeries and their short term outcomes at a small set of centers throughout the US.


Eligibility criteria: Inclusion Criteria:

1. Clinical condition included in the approved Indications For Use
2. Has signed the informed consent form to allow review of medical records and collection of data therein.
3. \> 18 years of age

Exclusion Criteria:

1. Treatment with iTotal in a manner inconsistent with Instructions for Use
2. Unwilling to sign then informed consent form

Primary outcomes:
measure: Knee Function
timeFrame: Average of 7 months post-operative
Secondary outcomes:
measure: Revision Rate
timeFrame: Average of 7 months
measure: Number of Transfusions
timeFrame: Initial hospital stay
measure: Manipulations Under Anesthesia
timeFrame: Up to 7 months post-operative
Other outcomes:
Locations:
city: La Quinta
country: United States
facility: STAR Orthopedics
state: California
city: Boynton Beach
country: United States
facility: Preferred Orthopedics of the Palm Beaches
state: Florida
city: Nashville
country: United States
facility: Tennessee Orthopaedic Alliance
state: Tennessee
city: Provo
country: United States
facility: Central Utah Clinic
state: Utah
Study officials:
References:
Clinical trial NCT01473654: The Avoiding Diabetes Thru Action Plan Targeting Pilot Randomized Control Trial
Official title: Avoiding Diabetes Thru Action Plan Targeting (ADAPT): A Pilot Randomized Control Trial of an Electronic Medical Record Embedded Prediabetes Shared Goal Setting Tool in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-11-17
Enrollment: 60
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 goal of this randomized control trial is to study the impact of an electronic health record embedded tool's ability to facilitate shared provider-patient goal setting to promote lifestyle behavior change and prevent diabetes in primary care.

Detailed description: The ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial is an innovative study that leverages persuasive technology to enhance the lifestyle behavior change counseling efficacy of primary care providers. Using principles of behavior change theory and persuasion technology, the multidisciplinary design team utilized in-depth interviews and in-vivo usability testing to produce a prototype diabetes prevention counseling system embedded in the electronic health record. The core element of the tool is a streamlined shared goal setting module within the electronic health record system. The system also utilizes a pre-encounter patient behavior change goals elicitation survey to help tailor the goal setting session to patient preferences and encourage shared decision making. The patients also interact with a website that collects their longitudinal behavior change data and visualizes their progress over time and in comparison to other study members. The ADAPT system utilizes the influential powers of goal setting, tailoring, reminders, social comparisons, testimonials and other methods to integrate evidence based behavior change principles and persuasion techniques into routine primary care clinical encounters. If successful, the ADAPT system may represent an adaptable and scalable technology-enabled behavior change tool for all primary care providers.

Eligibility criteria: Inclusion Criteria:

* prediabetes

Exclusion Criteria:

* age\<18
* diabetes

Primary outcomes:
measure: Physical Activity
timeFrame: 6 months
Secondary outcomes:
measure: hemoglobin a1c
timeFrame: 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
Study officials:
affiliation: Boston University
name: Devin Mann, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mann DM, Lin JJ. Increasing efficacy of primary care-based counseling for diabetes prevention: rationale and design of the ADAPT (Avoiding Diabetes Thru Action Plan Targeting) trial. Implement Sci. 2012 Jan 23;7:6. doi: 10.1186/1748-5908-7-6.
Clinical trial NCT03326154: Post-Cholecystectomy Quality of Life
Official title: Health Related Quality of Life and Abdominal Symptoms After Cholecystectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gallstone
Keywords: cholecystectomy
quality of life
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 1000
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: 1000

Brief summary: The study aims to identify factors associated with no increase in gastrointestinal quality of life after elective cholecystectomy for gallstones.


Eligibility criteria: Inclusion Criteria:

* laparoscopic cholecystectomy patients
* indication for operation symptomatic gallstones

Exclusion Criteria:

* previous complication of gallstone disease
* indication for cholecystectomy other than symptomatic gallstones
* illness significantly lowering quality of life
* inability to fill in questionnaires
* denies participation

Primary outcomes:
measure: Quality of life: Gastrointestinal Quality of Life GIQLI score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Jorvi, Helsinki University Hospital
city: Hyvinkää
country: Finland
facility: HUS Hyvinkää Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Hanna Lampela, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04438954: Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels
Official title: Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels of Multiple Sclerosis Patients in the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Covid-19
Keywords: Multiple Sclerosis
Covid-19 pandemic
Fatigue
Physical activity
Sleep quality
Anxiety
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Multiple Sclerosis

Brief summary: Hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after the first patients were identified in Wuhan, China. Just like other members of the community, MS patients are uncomfortable with the emotional distress and health anxiety caused by the COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies. Patients taking immunosuppressive agents are theoretically at increased risk of being affected by viral pandemics, and a higher health concern is expected in this group of patients. Moreover, MS patients lose social support. Patients with increased duration of stay can no longer access physical and cognitive rehabilitation therapies. We also know that increased anxiety and sleep disorders can cause MS patients to have an attack.

When literature is examined, it is known that MS patients' physical activity levels decrease, fatigue, sleep quality and anxiety levels increase, so their quality of life and participation in daily life activities decrease. MS patients lose social support during the COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level, anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further affected for these reasons.


Eligibility criteria: Inclusion Criteria:

* patients with a confirmed diagnosis of clinically definite MS, physician-administered Expanded Disability Status Scale (EDSS) range of 1-5, and following the instructions.

Exclusion Criteria:

* patients with acute attacks (three months prior to the study) and those included on the physiotherapy program during the Covid-19 pandemic.

Primary outcomes:
measure: Fatigue
timeFrame: 4 week
measure: Physical activity
timeFrame: 4 week
measure: Sleep quality
timeFrame: 4 week
measure: Anxiety
timeFrame: 4 week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Study officials:
References:
Clinical trial NCT00429754: Pharmacokinetic Study of Aprepitant in BEP Treatment of Patients With Testis Carcinoma (A-BEP)
Official title: A Pharmacokinetic Evaluation of the Addition of Aprepitant to the Bleomycin -Etoposide - Cisplatin (BEP) Treatment of Patients With Testis Carcinoma (A-BEP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Nausea
Vomiting
Keywords: Nausea and vomiting after using cytostatic drugs
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2007-02-01
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to investigate whether there is an interaction occurs between etoposide and aprepitant in patients with testis carcinoma treated with the standard BEP regimen.

Also to determine how long treatment with aprepitant is necessary in BEP regimen for 5 consecutive days.

Detailed description: Aprepitant is a novel, potent and selective nonpeptide neurokinin-1 receptor antagonist that was licensed in 2004 for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy.More recently the indication for use of aprepitant was extended to patients with moderately emetogenic chemotherapy. Based on experience with the use of aprepitant it appears rational to consider aprepitant as part of the anti-emetic regimen for patients treated with BEP. There are, however, no published data available for the use of aprepitant in this situation.

Eligibility criteria: Inclusion Criteria:

* between 18 and 75 years of age
* able and willing to sign Informed Consent Form
* subject has an indication for treatment with BEP regimen
* subject is expected to receive at least 2 cycles of BEP regimen
* subject is able to swallow capsules

Exclusion Criteria:

* documented history of sensitivity/idiosyncrasy to aprepitant or excipients
* relevant history or condition that might interfere with drug absorption
* history of or current abuse of drugs, alcohol or solvents
* inability to understand nature and extent of the trial and the procedures
* participation in a drug trial within 30 days prior to the first dose
* febrile illness within 3 days before the first dose
* use of agents that are known to interfere with aprepitant pharmacokinetics
* abnormal liver or renal function

Primary outcomes:
measure: Pharmacokinetic blood samples will be taken at day 2 at pre-dose,
measure: at 1/2 hour after intake, at 1, 4, 6, 8 and 24 hours (is day 3) after intake of medication.
measure: Also at day 5 at the same time points blood samples will be taken.
Secondary outcomes:
measure: Nausea and vomiting questionnaires will be answered at day 1,2,3,4,5,6,8 en 15.
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University (RUNMC)
name: David M. Burger, PharmD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03634254: Satisfaction Level of Communication Quality
Official title: Satisfaction Level of Communication Quality: a Survey for Primary Caregivers of AAC Users in New Taipei City
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Complex Communication Needs
Keywords: AAC
Satisfaction level of communication quality
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary caregivers of AAC users in New Taipei City

Brief summary: This study mainly explores the actual situation of AAC users in New Taipei City in their daily life after applying for social security subsidies, and the satisfaction of the main caregivers to AAC actually helping case communication. In summary, the main purposes of this study are as follows:

1. Discuss the communication satisfaction of the main caregivers to AAC users.
2. Explore the barriers to AAC users applying AAC.

Detailed description: This study was based on cross-sectional research, questionnaire survey, and the evaluation of the questionnaires by experts. The research tool part of the research and development reference to the domestic and foreign literature and questionnaires, developed a self-made questionnaire "communication quality satisfaction questionnaire", with continuous use and no continuous use of the auxiliary communication system as the self-variation in the study, in order to separately discuss the main caregiver Communication satisfaction of AAC users in different situations and activities in daily life, as well as obstacles in application

Eligibility criteria: Inclusion Criteria:

1. Apply for the communication from the New North City Access Center to identify the primary caregiver of the AAC users who have approved and purchased the AAC users.
2. The primary caregiver has normal communication skills and is interviewed by telephone.

Exclusion Criteria:

who may not participate in this study if you have any of the following conditions:

1. The main caregiver is unable to conduct telephone interviews due to physiological conditions (listening, deaf-mute)

Primary outcomes:
measure: Satisfaction of communication quality
timeFrame: 1 times conversation from phone call about 15 mints
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT03558854: Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients
Official title: Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Patients With Systemic Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Systemic Sclerosis
Keywords: Systemic sclerosis
Acetylsalicylic acid
Vascular dysfunction
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.


Eligibility criteria: Inclusion Criteria:

* Fulfill Systemic sclerosis EULAR/American College of Rheumatology 2013 classification criteria;
* Pharmacological treatment with stable dosages for the last three months.

Exclusion Criteria:

* Pregnancy;
* Use of anticoagulants, NSAIDs or antiplatelets drugs;
* Diagnose of other autoimmune rheumatic diseases, coronary diseases, cerebrovascular diseases and severe peripheral artery diseases;
* Active infection;
* Contraindication to acetylsalicylic acid use.

Primary outcomes:
measure: Serum level of thromboxane B2
timeFrame: Baseline and 4 weeks
Secondary outcomes:
measure: Serum level of platelet-derived, endothelial-derived and monocyte-derived microparticles
timeFrame: Baseline and 4 weeks
measure: Serum level of von Willebrand factor
timeFrame: Baseline and 4 weeks
measure: Serum level of endothelin-1
timeFrame: Baseline and 4 weeks
measure: Digital blood flow
timeFrame: Baseline and 4 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Systemic Sclerosis Outpatient Clinic, Hospital São Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Cristiane Kayser, PhD
role: STUDY_DIRECTOR
References: