louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT07018778: CMR-derived Quantitative Perfusion for Prediction of FFR
Official title: Quantification of Myocardial Blood Flow in Cardiovascular Magnetic Resonance for Prediction of Fractional Flow Reserve in Coronary Catheterisation
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Coronary Syndrome
Lead sponsor: Kerckhoff Klinik
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients referred to the clinical service for ischaemia evaluation

Brief summary: Patients will undergo quantitative perfusion assessment in cardiovascular magnetic resonance imaging (dual bolus or dual sequence approach) as well as invasive coronary angiography for assessment of fractional flow reserve (FFR) including assessment of coronary flow reserve (CFR) and microcirculatory resistance (IMR).


Eligibility criteria: Inclusion Criteria:

* clinical indication for vasodilatator CMR or invasive coronar angiography
* capability to give informed consent

Exclusion Criteria:

* general: non-compliance, \<18 years of age, pregnancy
* contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR \<30ml/min), allergies (medications)

Primary outcomes:
measure: Quantitative Perfusion
timeFrame: assessment of CMR and invasive data within 24hours
measure: Dual bolus vs dual sequence
timeFrame: assessment of CMR and invasive data within 24hours
Secondary outcomes:
measure: Strain
timeFrame: baseline CMR data
measure: Tissue characterisation
timeFrame: baseline CMR data
measure: Cardiovascular Hospitalisation (CVH)
timeFrame: 12 months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
state: Hesse
Study officials:
References:
Clinical trial NCT03742778: Incentivizing Reflection and Output in Exercise
Official title: Incentivizing Reflection and Output in Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: exercise
Incentives
reflection
output
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2018-11-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will test whether incentivizing post-workout activities (i.e., reflecting on workouts) is more effective than incentivizing actual workouts. This study has two conditions: reflection condition (with incentives for reflecting on workouts) vs. output (with incentives for working out). The focus of the incentives will be reinforced by three text messages per week and weekly emails.

Detailed description: Gym members register online to participate in a 28-day workout program. Upon registration, participants are assigned to one of two conditions (a condition that incentivizes reflecting on workouts or a condition that incentivizes workouts). Upon registration, participants are prompted to create a workout schedule and are given advice that reflecting on workouts can help build exercise habits. Over the 28-day intervention period, participants receive text message reminders prior to their scheduled workouts and emails reminding them of their schedules. In both conditions, participants receive points every day that they go to the gym, which can be redeemed for a gift card after the intervention period. In the reflection condition, participants can receive bonus points for responding to each of three text messages each week asking about them to reflect on their gym visits. In the output condition, participants receive the same text messages, but receive bonus points for their first three workouts each week, rather than for responding to text messages.

Eligibility criteria: Inclusion Criteria:

* 24 Hour Fitness member

Exclusion Criteria:

-

Primary outcomes:
measure: Gym visits per week
timeFrame: During the 28-day intervention period
measure: Gym visits per week
timeFrame: During the 4-week post-intervention period
measure: Gym visits per week
timeFrame: During the 10-week post-intervention period
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 28-day intervention period
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 4-week post-intervention period
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 10-week post-intervention period
Secondary outcomes:
measure: Gym visits per week
timeFrame: During the 52-week post-intervention period
measure: Whether or not a participant visits the gym in a given week
timeFrame: During the 52-week post-intervention period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03959878: Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
Official title: Feasibility of a Constant Pressure Skin Disk (CPSD) in Enteral Tubes.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrostomy
Keywords: Jejunostomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Researchers are gathering information on one specific part of a feeding tube, known as the adjustable skin disk. Researchers are trying to see if a new type of adjustable skin disk, called a Constant Pressure Skin Disk (CPSD), can safely and effectively support adequate healing, and reduced complication rates.

Detailed description: During the procedure of placing a gastrointestinal gastrostomy tube (GIG tube) or GI jejunostomy tube (GIJ tube), the gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk (CPSD) by sliding the former off and the latter on to the feeding tube.

Eligibility criteria: Inclusion Criteria:

* Age greater than or equal to 22 years
* Undergoing PEG tube or PEJ tube placement

Exclusion Criteria:

* History of tobacco or illegal drug use in the past year
* History of an enteral tube
* History of gastric surgery (bariatric surgery, Nissen fundoplication, etc.)

Primary outcomes:
measure: Constant Pressure Skin Disk (CPSD) durability
timeFrame: 180 days
Secondary outcomes:
measure: Adverse Events
timeFrame: 180 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Manpreet S Mundi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03221478: Effect of Kinesio Taping on the Stability of Knee in Soccer Players
Official title: Effect of Kinesio Taping and Proprioceptive Exercise on the Stability of Knee in Amateur Soccer Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Musculoskeletal System
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Objective: The general objective of this study is to determine the possible beneficial effect of the application of kinesiotaping, as well as the performance of proprioceptive exercises on parameters related to knee stability, such as the incidence of injuries, pain, static stability Or dynamics, and flexibility, in amateur soccer players, with a workload of 3 days per week plus the match.

Material and methods: Amateur soccer players are divided into 3 groups.

Group 1 (G1) performs proprioceptive exercises plus the application of kinesiotaping without tension in the knee.

Group 2 (G2) performs proprioceptive exercises plus the application of kinesiotaping with tension in the knee.

Group 3 (G3) is placed kinesiotaping with tension in the knee, without proprioception exercises.

The treatment will last four weeks and three evaluations, one before treatment, another at two weeks and the last one at the end of treatment.


Eligibility criteria: Inclusion Criteria:

* Football players
* Over 18 years with experience in this sport over 5 years

Exclusion Criteria:

* Players with pathologies that prevented them from playing football normally
* Recent serious injuries
* Allergy to kinesiotaping
* Impossibility to complete the study

Primary outcomes:
measure: KOOS knee questionnaire
timeFrame: 4 weeks
Secondary outcomes:
measure: Star Excursion Balance Test (SEBT)
timeFrame: 4 weeks
measure: Unipedal Stance Test (UST)
timeFrame: 4 weeks
measure: Sit and reach (Toe touch test)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Victoria Espí-López
Study officials:
affiliation: University of Physiotherapy
name: Gemma V Espí-López
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04331678: Evaluation of a Mobile App to Promote Social Support for Oncology Patients
Official title: Evaluation of a Mobile App to Promote Social Support for Oncology Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy Effect
Lead sponsor: West Cancer Center
Sponsor class: OTHER
Collaborators: name: Pfizer
name: Emory University
First posted: 2020-04-02
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Our study will evaluate patient and caregiver use of a new mobile application (app) to support patients undergoing chemotherapy treatment for cancer.

Detailed description: The app is designed to be used by the patient and members of their support network. It provides wide-ranging functionality, including: reminders for appointments and tasks, the ability to track health measures (fitness, emotion, pain, sleep), archive health related documents, maintain notes and recordings from visits, social networking functions to connect with family and friends to coordinate support activities and share news, and educational resources. We will randomize 230 patients initiating chemotherapy cancer treatment and up to one caregiver to the App group (asked to use the app once or more per week) or the Usual Care group, and evaluate the 3-month efficacy of app use on key outcomes.

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Patients must have a confirmed diagnosis of cancer and be prior to or within one month of initiating chemotherapy or immunotherapy
* Have a valid email address
* Have a smart mobile device (Android or iOS) with a data plan
* Willing to download and use the study app

Exclusion Criteria:

* Unable to communicate in English.

Primary outcomes:
measure: Change in Functional Assessment of Cancer Therapy-General (FACT-G) Score
timeFrame: Baseline, Three months
measure: Change in Short-Form Health Survey (SF-12)
timeFrame: Baseline, Three months
Secondary outcomes:
measure: Caregiver's Burden
timeFrame: Baseline, Three months
measure: Caregiver's Disruptiveness
timeFrame: Baseline, Three months
Other outcomes:
Locations:
city: Southaven
country: United States
facility: West Cancer Center
state: Mississippi
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Memphis
country: United States
facility: West Cancer Center
state: Tennessee
Study officials:
References:
citation: Graetz I, Hu X, Curry AN, Robles A, Vidal GA, Schwartzberg LS. Mobile application to support oncology patients during treatment on patient outcomes: Evidence from a randomized controlled trial. Cancer Med. 2023 Mar;12(5):6190-6199. doi: 10.1002/cam4.5351. Epub 2022 Oct 18.
Clinical trial NCT02978378: Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation
Official title: Renal Biomarkers to Predict Recovery Following Venoarterial Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Kidney Injury
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with cardiogenic shock and acute kidney injury requiring continuous renal replacement therapy

Brief summary: The investigators objective is to assess the utility of renal biomarkers in predicting renal recovery following institution of Venoarterial Extracorporeal Membrane Oxygenation (VA-ECMO). Tissue biomarkers of renal injury may provide a real-time indication of renal function and the likelihood of renal recovery in patients having cardiogenic shock and requiring VA-ECMO. In these patients, traditional markers of kidney function (urine output and serum Creatinine level) do not accurately represent renal function.


Eligibility criteria: Inclusion Criteria:

* age more than 18 years
* refractory or advanced cardiogenic shock prior to institution of VA-ECMO

Exclusion Criteria:

* History of chronic kidney disease prior to cardiogenic shock, as defined by estimated glomerular filtration rate (GFR) less than 60 mL per min
* Cognitive impairment
* Pregnant women
* patient or surrogate is not fluent in English
* Long-term immunosuppression

Primary outcomes:
measure: renal biomarker levels
timeFrame: through VA-ECMO decannulation, an average of 3 weeks
measure: need for continuous renal replacement therapy at hospital discharge (Yes/No)
timeFrame: measured at hospital discharge, an average of 2-3 months following initial hospital admission
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Anthony Bonavia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02194478: Stress Reduction for Busy Professionals
Official title: Pilot Study of a Brief Mind/Body Meditation Intervention for Allina Health Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: Stress
Meditation
Mind body
Lead sponsor: Allina Health System
Sponsor class: OTHER
First posted: 2014-07-18
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pre-post intervention pilot study to evaluate the impact of a 30-minute, 8-week mind-body/meditation intervention on self-reported quality of life in individuals employed by Allina Health. Outcomes will include validated questionnaires for depressive symptomology, perceived stress, anxiety, healthy lifestyle, quality of life as well as biological outcomes of salivary cortisol for a sub-sample of employees.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 65 years
* Actively-working healthcare professional employed by Allina Health.

Exclusion Criteria:

* Previous participation in an Allina Health stress reduction program
* Non-English speaking

Primary outcomes:
measure: Perceived stress change from baseline at week 8
timeFrame: Baseline, Week 8
Secondary outcomes:
measure: Salivary Cortisol Levels Change from baseline at week 8
timeFrame: Baseline, Week 8
measure: Lifestyle Profile change from baseline at week 8
timeFrame: Baseline, Week 8
measure: Work productivity and activity impairment change from baseline at week 8
timeFrame: Baseline, Week 8
measure: Promis-29 score change from baseline at week 8
timeFrame: Baseline, Week 8
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Allina Health
state: Minnesota
Study officials:
affiliation: Allina Health
name: Jeffery Dusek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06327178: Systemic Anti-tumor Activity and Safety of the Combination of SBRT and Concurrent PD-1 Blockade in Metastatic RCC.
Official title: Response to the Combination of Stereotactic Body Radiation Therapy and Concurrent PD-1 Blockade in Patients With Metastatic Renal Cell Carcinoma: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Anti-tumor Activity and Safety of the Combination of SBRT and Concurrent PD-1 Blockade in Metastatic RCC
Keywords: stereotactic body radiotherapy, abscopal effects
PD-1 blockade
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced metastatic clear cell renal cell carcinoma who have received SBRT and concurrent PD-1 blockade treatment.

Brief summary: Prior research has indicated that stereotactic body radiotherapy (SBRT) can effectively trigger systemic anti-tumor immune response. The goal of this observational study is to learn about abscopal effects of stereotactic body radiotherapy and concurrent anti-PD-1 antibody treatment in patients of metastatic clear renal cell carcinoma. The primary objective was to assess the objective response rate (ORR) in non-irradiated lesions, and incidence of adverse events (AEs).


Eligibility criteria: Inclusion Criteria:

* Age≥18 years at the time of signing informed consent;
* Histologically confirmed, advanced renal cell carcinoma of stage IV (AJCC 8);
* Previously received SBRT and concurrent PD-1 blockade treatment；
* Evidence of measurable metastatic kidney cancer according to RECIST 1.1 criteria.

Exclusion Criteria:

* Patients who cannot be adequately followed up;
* Has a known additional malignancy that is progressing or requires active treatment.

Primary outcomes:
measure: Objective Response Rate
timeFrame: Up to 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT05634278: Mindfulness Intervention in Orthopedic Trauma Patients
Official title: Pilot RCT of Mindfulness Intervention in Orthopedic Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project a single-site 3-arm parallel group randomized clinical trial conducted at a tertiary level 1 trauma center among patients undergoing operative fixation of a lower extremity fracture.


Eligibility criteria: Inclusion Criteria:

* Age at presentation between 18 and 65 years
* Acute lower extremity fracture to be operatively managed
* Glasgow Coma Scale of 15
* English speaking
* Willingness to participate in study

Exclusion Criteria:

* Cognitive impairment
* Pregnant or lactating woman
* Current incarceration
* Planned secondary procedure

Primary outcomes:
measure: Change in Preoperative Anxiety
timeFrame: Immediately before to after the 7-minute preoperative intervention
measure: Change in Postoperative, In-patient Pain Unpleasantness
timeFrame: Immediately before to after the 7-minute postoperative intervention
Secondary outcomes:
measure: Change in Preoperative Pain Intensity
timeFrame: Immediately before to after the 7-minute preoperative intervention
measure: Change in Postoperative, In-patient Pain Intensity
timeFrame: Immediately before to after the 7-minute postoperative intervention
measure: Change in Preoperative Pain Unpleasantness
timeFrame: Immediately before to after the 7-minute preoperative intervention
measure: Change in Postoperative, In-patient Anxiety
timeFrame: Immediately before to after the 7-minute postoperative intervention
Other outcomes:
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Item Bank, v2.0
timeFrame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference Bank v1.1
timeFrame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Bank v1.0
timeFrame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
measure: Postoperative Patient Reported Outcomes Measurement Information System (PROMIS) Depression Bank v1.0
timeFrame: Assessed at 2-weeks, 6-weeks, 3-months, 6-months and 12-months postoperatively
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
Clinical trial NCT03360578: Measuring Physiology to Determine if Pre-panic Attack Detection is Possible
Official title: Measuring Physiology in Individuals With Panic Disorder to Determine if Panic Attack Detection is Possible
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Panic Disorder
Lead sponsor: Medical Psychology Center
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18-65 individuals with panic disorder that are mentally capable to consent and are not pregnant

Brief summary: Participants will be asked to wear a physiological monitoring device for 1 week and record when panic events occur. Once the device is returned, the data will be downloaded and analyzed.


Eligibility criteria: Inclusion Criteria:

* Panic disorder as described in the Diagnostic and Statistical Manual - 5 (DSM-5)

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: Panic event
timeFrame: 1 year
measure: Heart Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly
country: United States
facility: Medical Psychology Center
state: Massachusetts
Study officials:
References: