louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02382783: Optimizing the Management of Flares in Patients With Rheumatoid Arthritis (RA)
Official title: Optimization of the Flare Management in Rheumatoid Arthritis (RA) by Implementing Patient-driven Systematic Changes to the RA Ambulatory Care Stream
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Disease Activity
Flare
Management of Flares
Pfizer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2015-03-09
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine how best to monitor for flares in patients with rheumatoid arthritis (RA).

Detailed description: This project is aimed at developing an improved multilevel care process model for the management of rheumatoid arthritis (RA) disease activity by implementing systematic self-monitoring of flare experiences by RA patients, combined with continuous patient-tailored adjustments of treatment modalities by a coordinated team of rheumatology health care providers (RHCPs).

Eligibility criteria: Inclusion Criteria

* Patient must be ≥ 18 years of age.
* Patient must have been seen by a rheumatology health care provider at least two times within the last 18 months at Mayo Clinic Rochester.
* Patient must have rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria.
* Patient must have the ability to understand and the willingness to sign a written informed consent document.
* Patient must be willing to return to Mayo Clinic Rochester for follow-up appointments and fill out questionnaires as outlined in the study.

Primary outcomes:
measure: Flare Occurrence
timeFrame: Anticipated length of study is two years.
measure: Flare-to-visit Time
timeFrame: Anticipated length of study is two years.
Secondary outcomes:
measure: Participant Satisfaction
timeFrame: Three time-points: baseline, year one, and end of study. Anticipated length of study is two years.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eric L Matteson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bingham CO 3rd, Pohl C, Woodworth TG, Hewlett SE, May JE, Rahman MU, Witter JP, Furst DE, Strand CV, Boers M, Alten RE. Developing a standardized definition for disease "flare" in rheumatoid arthritis (OMERACT 9 Special Interest Group). J Rheumatol. 2009 Oct;36(10):2335-41. doi: 10.3899/jrheum.090369. Epub 2009 Aug 14.
citation: Myasoedova E, Crowson CS, Giblon RE, McCarthy-Fruin K, Schaffer DE, Wright K, Matteson EL, Davis JM 3rd. Optimization of flare management in patients with rheumatoid arthritis: results of a randomized controlled trial. Clin Rheumatol. 2019 Nov;38(11):3025-3032. doi: 10.1007/s10067-019-04664-5. Epub 2019 Jul 1.
Clinical trial NCT06269783: Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis
Official title: Dual-process Mechanisms of Action for sipIT Intervention Effects in Patients With Urolithiasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Stone
Urolithiasis
Nephrolithiasis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to clarify the fundamental processes underlying behavior change, maintenance, and adherence during and after a 3-month fluid intake intervention period.

Detailed description: The study is a six-month ecological momentary assessment study of patients using the mini-sipIT intervention for 3 months, with weekly assessments of motivation and life events or stressors that disrupt routines during the 3-month intervention period, and monthly assessments of motivation and life events or stressors that disrupt routines in the three months following the end of intervention (months 4-6). The mini-sipIT intervention includes automated and manual tracking of fluid intake and lapse-contingent reminders to drink.

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of symptomatic kidney stone in the past 5 years,
* Age 18 or older,
* Own an iOS or Android smart phone,
* Proficient in English,
* Capable of providing informed consent,
* Willing to use the water bottle and companion app \& receive text message reminders for 3 months,
* Live in continental US.

Exclusion Criteria:

* Pregnant or planning to become pregnant during the next 6 months,
* Concurrently participating in other study involving fluid intake or diet,
* Plan to have surgery in the next 6 months,
* Co-morbidities that preclude high fluid intake (congestive heart failure, end-stage renal disease, chronic hyponatremia), or
* Active medical treatments that would impair protocol compliance.

Primary outcomes:
measure: Urine volume (intervention)
timeFrame: from baseline to the end of the intervention period (3 months)
Secondary outcomes:
measure: Urine volume (maintenance)
timeFrame: from the end of the intervention period (3 months) to the maintenance change at 6 months
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06931483: The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD
Official title: The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Temporal Interference Stimulation
Parkinson's Disease
the Right Globus Pallidus Internus
Motor Symptoms
Keywords: temporal interference stimulation
Parkinson's Disease
motor symptoms
the right globus pallidus internus
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.

Detailed description: Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.

Eligibility criteria: Inclusion Criteria:

1. Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
2. Hoehn-Yahr stage 1.5-4;
3. Age \> 50 years old;
4. No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score \< 20;
5. No signs of dementia: Mini-Mental State Examination (MMSE) score \> 21;
6. No change in medication regimen in the four weeks prior to enrollment;
7. Right-handed.

Exclusion Criteria:

1. History of other neuropsychiatric disorders;
2. History of alcohol or drug abuse;
3. Previous history of TMS or traditional TES treatment;
4. Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.

Primary outcomes:
measure: Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: On intervention Day 1, Day 10 and 1-month follow-up.
Secondary outcomes:
measure: emotional symptoms assessed by the HAMA
timeFrame: on intervention Day 1, Day 10 and 1-month follow-up
measure: emotional symptoms assessed by the HAMD
timeFrame: On intervention Day 1, Day 10 and 1-month follow-up.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References:
Clinical trial NCT00162383: Metabolic Capacity of Israeli Populations
Official title: Phenotypic and Genotypic Evaluation of Cytochrome P450 Isoforms in Populations of Different Ethnic Composition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 1200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The ability to metabolize drugs varies greatly among individuals. Major fraction of this variability lies in genetic polymorphisms of genes encoding for enzymes responsible for both phase I and phase II reactions.

The purpose of this study ws to evaluate the phenotypic activity and the frequency of genetic polymorphisms in different phase II and phase I enzymes among various populations residing in Israel.


Eligibility criteria: Inclusion Criteria:

* Age range 20-50
* Absence of significant disease state

Exclusion Criteria:

* The presence of significant disease states
* The regular use of drugs (including birth control pills)

Primary outcomes:
measure: Phenotypic measurements of various P450 and non-P450 enzymes involved in drug metabolism.
timeFrame: 24 hours
measure: Frequency of genetic polymorphisms in these enzymes among different Israeli populations.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Yoseph Caraco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01212497: Virtual Coach for Mindfulness Meditation Training
Official title: Virtual Coach for Mindfulness Meditation Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness Training
Keywords: mindfulness
meditation
training
coaching
virtual coach
Lead sponsor: Psychometrix Associates
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Evaluate the effectiveness of using a virtual computer coach to provide mindfulness meditation training, and the coaching support required to initiate a regular practice.


Eligibility criteria: Inclusion Criteria:

* over 18, no previous mindfulness experience, computer literacy

Exclusion Criteria:

* substance abuse, anxiety/depression, psychosis

Primary outcomes:
measure: Frequency of meditating
timeFrame: 7 weeks (weekly)
Secondary outcomes:
Other outcomes:
Locations:
city: Blacksburg
country: United States
facility: Psychometrix Associates
state: Virginia
Study officials:
affiliation: Psychometrix Associates
name: Eva Hudlicka, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001597: Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy
Official title: Intra-operative Trans-rectal Ultrasound Guidance for Robot-assisted Radical Prostatectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: surgery
robotic
ultrasound
guidance
endorectal
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: British Columbia Innovation Council
First posted: 2013-12-05
Enrollment: 20
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men who undergo robot-assisted radical prostatectomy.

Brief summary: Radical prostatectomy, or the surgical extirpation of the prostate, is a standard treatment for prostate cancer. The state of the art radical prostatectomy involves a robotic laparoscopic surgery system (the da Vinci) which provides the surgeon with excellent 3D visualization of the surgical site and improved dexterity over standard laparoscopic instruments. While the long term prognosis of prostate cancer patients who undergo radical prostatectomy has improved significantly over the past two decades, there remain significant rates of disease recurrence and complications.

The investigators hypothesis is that advanced trans-rectal ultrasound (TRUS) imaging can be deployed and used easily during surgery, can be registered to the robot coordinate systems with high accuracy, and can be controlled from the surgeon's console, in order to improve the visualization of the prostate and peri-prostatic anatomy, and in order to produce a cancer probability map that can be used to make decisions on surgical margins.

The investigators objectives are

1. To demonstrate that TRUS imaging can be integrated with the da Vinci radical prostatectomy
2. To determine the ability of TRUS imaging to intra-operatively visualize the prostate and peri-prostatic tissue from the surgical console

This is an observational study; trans-rectal ultrasound will be used to visualize the prostate and periprostatic structures during surgery but the standard of care will not be affected by this ultrasound imaging.


Eligibility criteria: Inclusion Criteria:

* All men who undergo robot-assisted radical prostatectomy are eligible.

Exclusion Criteria:

* None

Primary outcomes:
measure: Time required to register the trans-rectal ultrasound coordinates to the da Vinci coordinates
timeFrame: 1 year
Secondary outcomes:
measure: Successful prostate visualization
timeFrame: 1 year
Other outcomes:
measure: Impact on completion time
timeFrame: 1 year
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
References:
Clinical trial NCT05196997: The De-Morton Mobility Index Turkish Version in Intensive Care Patients
Official title: Construct Validity and Test-Retest Reliability of The De-Morton Mobility Index Turkish Version in Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Function
Mobility
Keywords: critical care
function
mobility
Lead sponsor: Izmir Katip Celebi University
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged above 18 years who stayed in the intensive care unit for at least 24 hours and were discharged from the ICU were included in our study.

Brief summary: De Morton Mobility Index is recommended for the evaluation of mobility in the evidence-based guidelines, in patients in intensive care units. The aim of our study is to examine the validity and reliability of the Turkish version of the De Morton Mobility Index in patients hospitalized in the respiratory intensive care unit.

Detailed description: De Morton Mobility Index is recommended for the evaluation of mobility in the evidence-based guidelines, in patients in intensive care units. The aim of our study is to examine the validity and reliability of the Turkish version of the De Morton Mobility Index in patients hospitalized in the respiratory intensive care unit.

Patients aged 18 years and over who were discharged from the ICU were included in our study.

We used De-Morton Mobility Index, Bartel Index, Katz Activities of Daily Living Rating Scale and MRC Muscle Strength Test for convergent validity. De-Morton Mobility assessment for test-retest reliability was performed again on the 1st day of the patient's service.

Eligibility criteria: Inclusion Criteria:

* staying in intensive care unit for at least 24 hours
* able to cooperate
* being clinically stable for mobility assessment

Exclusion Criteria:

* the presence of neurological disease
* the presence of orthopedic problems such as fractures
* the presence of metastases
* the presence of cardiorespiratory instability

Primary outcomes:
measure: Mobility Assessment
timeFrame: 15 minutes
Secondary outcomes:
measure: Functional independence measurement
timeFrame: 5 minutes
measure: Assessment of daily living activities
timeFrame: 5 minutes
measure: Muscle Strength
timeFrame: 10 minutes
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: İlknur Naz Gürşan
Study officials:
References:
citation: Naz I, Turgut B, Ediboglu O, Kirakli C. Clinimetric properties of the Turkish version of the De-Morton Mobility Index (DEMMI) in intensive care unit survivors - a cross-sectional observational study. Disabil Rehabil. 2023 Nov;45(22):3730-3736. doi: 10.1080/09638288.2022.2134935. Epub 2022 Oct 20.
Clinical trial NCT06032897: Impact of Individualized Music Listening for People With Dementia on Anxiety: A Quasi-experimental Study
Official title: The Effect of Personalized Music on the Elderly With Cognitive Impairment and Dementia: a Quasi-experimental Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Listening
Keywords: dementia
individualized music listening
anxiety
behavior
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot study was designed to evaluate the effects of Individualized music listening (IML) implemented on older adults with mild cognitive impairment (MCI) and PwD. This quasi-experimental study used convenience sampling where thirty-two elderly individuals were recruited from five community-based dementia care centers then assigned to experimental (EG, n = 16) or control (CG, n = 16) groups according to the self-reports of importance of music in their lives and according to their personal wishes. The EG received eight treatments of IML (two times per week, 20 minutes per time), while the CG received the usual activities of the care centers for four weeks when EG received IML. The anxiety levels of both groups were investigated before and after first time IML and after eighth time IML. The researcher observed positive and negative behaviors of EG before, during and after each IML per 20 minutes in each time IML.


Eligibility criteria: Inclusion Criteria:

1. 50 years or older;
2. Mild cognitive impairment or dementia.

Exclusion Criteria:

1. Can not answer questions by themselves;
2. Have the habit of listening music in the past week.

Primary outcomes:
measure: Anxiety
timeFrame: First day: before the first time individualized music listening; first day: after completing first-time individualized music listeningof 20 minutes; the fourth week: after the last (eighth) time Individualized music listening of 20 minutes.
measure: Behavioral
timeFrame: Four weeks: eight times of individualized music listening. Before 20 minutes, during 20 minute, after 20 minute of every time individualized music listening.
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
affiliation: Kaohsiung Medical University
name: Pei-Chao Lin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03878797: The Depth of Endotracheal Tube Insertion
Official title: An Observational Study of The Depth of Endotracheal Tube Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endotracheal Intubation
Keywords: Endotracheal tube
Endobronchial intubation
Vocal cords
Bronchoscopy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients who are scheduled for elective surgery under general anesthesia

Brief summary: Virtual experiment : comparing the new method with conventional method of determining the depth of endotracheal intubation.

Detailed description: Effective airway management is the primary concern of the anesthesiologist. The conventional method of determining the insertion length of the endotracheal tube, 21 cm for women and 23 cm for men, shows a high incidence of endobronchial intubations in the analyzed population.The aim of this study is form a new and safe practice habit by passing the endotracheal tube with the balloon just 2 cm below the vocal cords during intubation.

Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled for elective surgery under general anesthesia

Exclusion Criteria:

* Patients with anatomical defects of the face, neck, or upper airway
* Patients at risk for pulmonary aspiration of gastric content

Primary outcomes:
measure: the depth of primary insertion of tracheal tube
timeFrame: in a minute after intubation
Secondary outcomes:
measure: the distance from the corner of mouth to the carina
timeFrame: in a minute after intubation
measure: the distance from the vocal cords to the carina
timeFrame: in a minute after intubation
measure: the distance from the corner of mouth to the vocal cords
timeFrame: in a minute after intubation
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References: