louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03455244: Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
Official title: Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multi Vessel Coronary Artery Disease
Lead sponsor: CathWorks Ltd.
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 50
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: Subjects with stable angina, unstable angina or NSTEMI who are referred to coronary angiography, have multi-vessel coronary artery disease and have an invasive FFR measurement at two lesions at minimum. Each subject will undergo both the standard invasive FFRs and the investigational FFRangio.

Brief summary: This is a prospective, observational, single-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis in Multi-Vessel Disease.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age.
* Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses.
* Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus.
* Written, informed consent.

Exclusion Criteria:

* Contraindication for FFR examination or administration of vasodilators.
* Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year.
* CTO in a target vessel.
* Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation.
* Known LVEF ≤45%.
* Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging.
* TIMI Grade 2 or lower at baseline.
* Target lesions involve Left Main (stenosis ≥50%.)
* In-stent restenosis in a target vessel.
* Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree.
* Target coronary vessels are supplied by major collaterals.
* Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery.
* Coronary angiograms not acquired per instructions as defined in the Study Protocol.

Primary outcomes:
measure: Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR
timeFrame: 1 hour
Secondary outcomes:
measure: Continuously scored FFR (FFRangio and Invasive FFR).
timeFrame: 1 hour
measure: Accuracy, Positive predictive value and negative predictive value per vessel and per lesion
timeFrame: 1 hour
Other outcomes:
Locations:
city: Gifu
country: Japan
facility: Gifu Heart Center
Study officials:
References:
Clinical trial NCT00969644: The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons
Official title: The Relationship Between the Growth Hormone (GH)- Insulin Like Growth Factor I (IGF-I) System and the Inflammatory System in Healthy Normal Persons
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interaction Between the GH/IGF-I System and the Immune-system
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Observations in patients with growth hormone (GH)-disturbances have suggested that GH/IGF-I might have anti-inflammatory effects. To elucidate this hypothesis the investigators have planned a study to investigate if 3 weeks administration of GH and subsequently the GH antagonist Pegvisomant (or vice versa) influence serum levels of different inflammatory markers in healthy volunteers.

Detailed description: To investigate if administration of 3 weeks og GH (10-30 microgram/kg/day) and subsequent Pegvisomant (10-15 mg/day) influence serum concentrations of the inflammatory variables Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and the newly discovered acute phase protein YKL-40. The study involves 12 healthy volunteers age from 22-65 years.

Eligibility criteria: Inclusion Criteria:

* Healthy, normal blood tests

Exclusion Criteria:

* Previous cancer

Primary outcomes:
measure: The relationship between changes in serum levels of Tumor Necrosis Factor α (TNF-α), Interleukin-6 (IL-6), high sensitive CRP (hsCRP) and YKL-40 vs. changes in serum levels og IGF-I
timeFrame: 1/9 2009 - 1/3 2010
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Endocrinology J 106, Herlev Hospital
Study officials:
References:
citation: Andreassen M, Frystyk J, Faber J, Kristensen LO, Juul A. Growth hormone (GH) activity is associated with increased serum oestradiol and reduced anti-Mullerian hormone in healthy male volunteers treated with GH and a GH antagonist. Andrology. 2013 Jul;1(4):595-601. doi: 10.1111/j.2047-2927.2013.00096.x.
Clinical trial NCT00644644: Validation of the NTX Wireless Patient Monitoring System
Official title: A Validation of the NTX Wireless Patient Monitoring System in Combination With Novel Computer Interface to Generate Proactive Medical Responses to Patient Specific Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Desaturation
Bradycardia
Tachycardia
Hypertension
Hypotension
Keywords: NTX
Nihon Kohden
mobile monitoring
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-03-27
Enrollment: 1303
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post-op orthopedic and GI patients who will be admitted for a minimum of 24 hours to the Round Wing area of Vanderbilt University Medical Center.

Brief summary: * Reduction in time to detection of Clinically Significant events
* Reduction of time to Intervention during Clinically Significant events
* Reduction in the number of admissions to Intensive Care

Detailed description: 1200 patients will have wireless monitors attached to their arm. They will be randomized to have their vital signs filtered through software that generates alerts, or software that does not generate alerts. Low and high limit alarms will be set according to published guidelines and adjusted at will by the response team. If appropriate the Vanderbilt University Medical Center Rapid Response team will be initiated per Institutional Policy

Eligibility criteria: Inclusion Criteria:

* Ability to give written informed consent
* Patients that are hospitalized for longer than 24 hours and are located on the 4th, 5th, or 6th floor of the Vanderbilt University Medical Center Round Wing
* Patients must be ≥18 years of age

Exclusion Criteria:

* ICU patients
* Female subjects who are pregnant
* Patients \< 18 years of age
* Patients that have a contradiction for continuous Blood Pressure monitoring

Primary outcomes:
measure: To determine if the NTX wireless monitoring system in combination with a novel computer interface will provide early detection of potentially life threatening changes in patient's vital signs
timeFrame: an interim analysis will be performed after 400 patients have been placed on the study, again after 800 have been places on the study
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Daniel J France, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01162044: Examining an Emergency Room Intervention for the Prevention of Post Traumatic Stress Disorder (PTSD)
Official title: Interrupting Traumatic Memories: An Emergency Room Intervention for the Prevention of PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
prevention
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 80
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: PREVENTION

Brief summary: PTSD is a common and distressing possible outcome following exposure to a traumatic event. Recent studies show that memory processes may be central to the development of the disorder, and interrupting the consolidation of traumatic memories may prevent the disorder from developing. Specifically the use of a visual spatial task has been shown to reduce a key characteristic of PTSD, intrusions, in non-clinical populations. This study aims to administer a visual spatial task to recent trauma survivors in the Emergency Room, and compare PTSD and symptoms development in these patients as compared to a control group who did not carry out the task. The study hypothesizes that the task will result in less PTSD, lower levels of intrusions, dissociation and pain.


Eligibility criteria: Inclusion Criteria:

* age 18-65,
* no loss of consciousness,
* ability to understand study procedures and give informed consent,
* Hebrew as first language,
* experienced a potentially traumatic event as defined in DSM (objective danger and subjective feeling of fear).

Exclusion Criteria:

* current or past psychiatric treatment,
* current or past PTSD.

Primary outcomes:
measure: PTSD symptoms
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Rena Cooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01320644: A Study of Robotic Assisted Laparoscopic Sacral Colpopexy Using Alyte Mesh
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Urinary Incontinence
Mesh Erosion
Keywords: Uterine prolapse
vaginal prolapse
mesh erosion
urinary incontinence
bowel symptoms
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 150
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be woman who underwent robotic assisted laparoscopic sacral colpopexy at Morristown Memorial Hospital for the correction of pelvic organ prolapse using synthetic polypropylene mesh

Brief summary: Robotic approach to sacral colpopexy is a relatively new procedure. The literature is scarce in regard to long term outcomes. This advanced procedure is offered at Morristown Memorial. THis protocol will review the one year outcome of patients who underwent this pocedure using a polypropylene mesh. These outcomes will incude anatomical and quality of life measures.


Eligibility criteria: Inclusion Criteria:

* Any patient receiving Robotic assisted laparoscopic sacral copopexy with polypropylene mesh
* \>21 y.o

Exclusion Criteria:

* Graft material other than polypropylene mesh
* Enrollment in another study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
Study officials:
References:
Clinical trial NCT03585244: Weight Change in PWS Over Six Months
Official title: A Study to Assess Change in Weight Over Six Months in Prader-Willi Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Change, Body
Lead sponsor: Foundation for Prader-Willi Research
Sponsor class: OTHER
Collaborators: name: Prader-Willi Syndrome Association USA
First posted: 2018-07-12
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with PWS

Brief summary: This is a completely text-messaging based study and all data will be collected via surveys administered on a mobile phone. For this study, we will gather and analyze data on changes in body weight over a 6-month interval in individuals aged 12 and over. This will help us learn more about the normal variation in weight, over time, in the PWS population.

Detailed description: The incidence and natural history of several PWS symptoms are poorly defined. In this text-messaging based study we will gather and analyze data on changes in body weight over a 6-month interval, in individuals aged 12 and over. We would like to learn about the normal weight variation in the PWS population.

We anticipate that this study will inform future clinical trials for hyperphagia/obesity related therapies, and provide a basis for understanding how well potential therapies are working. For this study, there will be no intervention and the all data will be collected via texting.

Eligibility criteria: Inclusion Criteria:

Participants with PWS are eligible for this study. Eligible PWS participants must be 12 years and older. Participant/legal representative of participant must have a text messaging enabled mobile phone in order to participate in the study Participants must reside in the U.S. or Canada

-

Exclusion Criteria:

Primary outcomes:
measure: Percent of Change in Weight
timeFrame: baseline and 6 months
measure: Percent of Change in BMI
timeFrame: baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Walnut
country: United States
facility: Remote
state: California
Study officials:
References:
Clinical trial NCT06319144: Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
Official title: Effect of Intravenous 5% Dextrose Infusion During Recovery from Anesthesia on the Quality of Early Postoperative Recovery in Patients Undergoing Painless Gastrointestinal Endoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Postoperative Nausea and Vomiting
Quality of Recovery
Dizzyness
Keywords: Glucose injection Solution
PONV
Lead sponsor: Weifang Medical University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study was to determine the effect of intravenous infusion of 5% dextrose injection during the recovery period of anesthesia for painless gastroenteroscopy on the patient's blood glucose level, incidence of hypoglycemia and time of awakening from anesthesia, postoperative vertigo, postoperative nausea and vomiting, and quality of recovery in the early postoperative period.


Eligibility criteria: Inclusion Criteria:

1. patients who meet the indications for painless gastrointestinal endoscopy and are aged 18 to 79 years.
2. The patient or his/her guardian or immediate family members gave informed consent;
3. American Society of Anesthesiology (ASA) anesthesia risk classification ≤ grade III.

Exclusion Criteria:

1. Patients with contraindications to sedation/anesthesia for gastrointestinal endoscopy: e.g., severe hepatic and renal dysfunction, cardiac insufficiency;
2. Patients receiving chemotherapy and opioid treatment; patients with a history of sleep apnea hypoventilation syndrome;
3. Intravenous nutritional support within 8 hours prior to the examination;
4. Patients diagnosed with type I or type II diabetes.

Primary outcomes:
measure: Preoperative blood glucose 30min
timeFrame: Measurements taken 0.5 hours Preoperative.
measure: Postoperative blood glucose 2h
timeFrame: Measured at 2 hours postoperatively.
measure: Dizziness level
timeFrame: Approximately 15min after surgery
measure: Dizziness level
timeFrame: Measured at 0.5 hours postoperatively.
measure: Postoperative nausea and vomiting
timeFrame: Measured at 0.5 hours postoperatively.
measure: Postoperative nausea and vomiting
timeFrame: Measured at 2 hours postoperatively.
Secondary outcomes:
measure: Anesthesia awakening time
timeFrame: Approximately 30min after surgery
measure: Quality of postoperative recovery (QoR40)
timeFrame: Approximately 24hours after surgery
Other outcomes:
Locations:
city: Weifang
country: China
facility: Lin Cheng
state: Shandong
Study officials:
affiliation: Weifang People's Hospital
name: Lin Cheng, B.S
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05388344: LUMINA : Measure the Effectiveness of the Booklet Named "Comprendre Les Essais Cliniques"
Official title: LUMINA : Measure the Effectiveness of the Booklet Named "Comprendre Les Essais Cliniques" With Patients Included or Not Included in Clinical Trials Within the Clinical Neurosciences - Rheumatology Pole of the CHU de Nice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants coming for a consultation or an hospitalization within the Clinical Neurosciences-Rheumatology pole of the CHU de Nice

Brief summary: Various studies have shown that many patients do not understand all the information provided by the study investigator and by the information sheet before entering a clinical research protocol. Many materials has been developped in previous research, trying to improve patients' understanding. Nonetheless, their effectiveness remains uncertain.

The "LUMINA" project aims to measure the effectiveness of the booklet named "Comprendre les essais cliniques" with patients included or not included in clinical trials within the Clinical Neurosciences - Rheumatology pole of the CHU de Nice. The design of this study is "before/after". A questionnaire was submitted to the patients before and after reading the booklet. That method is used in order to show if there was a difference between the score obtained from the questionnaire before and after reading. This difference could reflect an improvement in patients' comprehension and, by extension, the effectiveness of the support the team developed.


Eligibility criteria: Inclusion Criteria:

* age \<18
* patient coming for a consultation or an hospitalization within the Clinical Neurosciences-Rheumatology pole of the CHU de Nice, or companions/caregivers who helps the patients understand
* Patient able to read and to understand the french language,
* Patient included or not in clinical trials.

Exclusion Criteria:

* Participants unable to read
* Patient unable to understand the french language

Primary outcomes:
measure: Evaluate the effectiveness of the booklet
timeFrame: day 1
Secondary outcomes:
measure: Assess the booklet's lisibility
timeFrame: day 1
measure: Assess the difference in understanding between patient groups
timeFrame: day 1
measure: Measurement of the patients' satisfaction
timeFrame: day 1
measure: Assess the booklet comprehension
timeFrame: day 1
Other outcomes:
Locations:
city: Nice
country: France
facility: Nice University Hospital
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Christine LEBRUN-FRENAY
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04124744: A Pilot Randomised Controlled Trial of a Health Champion Intervention
Official title: A Pilot Randomised Controlled Trial of a Volunteer Health Champion Intervention to Support People With Severe Mental Illness to Improve Their Physical Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: South London and Maudsley NHS Foundation Trust
First posted: 2019-10-11
Enrollment: 100
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: This study is a pilot RCT to evaluate the effectiveness and implementation challenges of an intervention using volunteer 'Health Champions' matched with service users to support service their physical health goals.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years old with a serious mental illness (Mood \[affective\] disorders \[F30-F39\], Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders \[F20-F29\]).
* Currently with a Community Mental Health Team (CMHT).
* Want to make changes to their physical health.
* Has capacity to give written informed consent to take part in the project.
* Able to provide a named Care Coordinator or Point of Contact reachable in the event of a health crisis.

Exclusion Criteria:

* • Under 18 years of age

  * Unable to give informed consent

Primary outcomes:
measure: EQ-5D-3L
timeFrame: Change in outcome from baseline at 9 months and 15 months
Secondary outcomes:
measure: Recovering Quality of Life Questionnaire-ReQOL
timeFrame: Change in outcome from baseline at 9 months and 15 months
measure: Patient Activation Measure
timeFrame: Change in outcome from baseline at 9 months and 15 months
measure: Multimorbidity Treatment Burden Questionnaire
timeFrame: Change in outcome from baseline at 9 months and 15 months
measure: De Jong Gierveld Loneliness Scale
timeFrame: Change in outcome from baseline at 9 months and 15 months
measure: Health screenings in last 6 months
timeFrame: change in number of health screenings from baseline at 9 months and 15 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
References:
citation: Williams J, Fairbairn E, McGrath R, Bakolis I, Healey A, Akpan U, Mdudu I, Gaughran F, Sadler E, Khadjesari Z, Lillywhite K, Sevdalis N. A feasibility hybrid II randomised controlled trial of volunteer 'Health Champions' supporting people with serious mental illness manage their physical health: study protocol. Pilot Feasibility Stud. 2021 May 31;7(1):116. doi: 10.1186/s40814-021-00854-8.