louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03641937: INVSENSOR00011 Clinical Performance Study
Official title: INVSENSOR00011 Clinical Performance Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.


Eligibility criteria: Inclusion Criteria:

* 18 to 80 years old
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement
* Passed health assessment screening

Exclusion Criteria:

* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Nursing female volunteers
* Excluded at the Principal Investigator's discretion
* Refusal to take pregnancy test (for female subjects)
* Positive pregnancy tests for female subjects of child bearing potential.
* Refusal to shave hair off areas where sensors will be applied (male subjects)

Primary outcomes:
measure: Sensitivity of INVSENSOR00011's Posture Change Detection
timeFrame: Approximately 30 minutes
Secondary outcomes:
measure: Respiratory Rate Detection
timeFrame: Approximately 20 minutes
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
References:
Clinical trial NCT00178737: Does the Message Matter? Enhancing Adherence in Healthcare Through Persuasive Messages
Official title: Does the Message Matter? Enhancing Adherence in Healthcare Through Persuasive Messages
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appointment Reminders
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this research we propose to develop a comprehensive model to explain how users process persuasive messages. We then propose to experimentally test varying the persuasiveness of message content in various domains, and assess their impact on adherence by both physicians and patients. Finally based on our conceptual model and results from the experimental data we propose to develop preliminary guidelines to assist developers in designing effective messages.


Eligibility criteria: Inclusion Criteria:

Study 1

1. Subjects who have an appointment scheduled at HCHD Baytown Health Center

Study 2

1. Subjects who are neonatology physicians (not in training).
2. Subjects must be able to give signed informed consent.

Study 3

1. Any subjects (students or employee) at the University of Texas Health Science Center at Houston.
2. Subjects must be able to give signed informed consent.

Exclusion Criteria:

* No specific individual who meets the inclusion criteria will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Muhammad F Walji, M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03853837: Ventricular and Pulmonary Vascular Reserve After the Fontan Operation
Official title: Ventricular and Pulmonary Vascular Reserve After the Fontan Operation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Congenital Heart Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-02-26
Enrollment: 32
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: NON_PROBABILITY_SAMPLE
Study population: Fontan palliation

Brief summary: Aim #1: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing.

Aim #2: Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology.

Aim #3: Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction.

Detailed description: Define and determine the prevalence of pulmonary vascular disease and diastolic dysfunction as assessed by the gold standard of invasive hemodynamic cardiopulmonary exercise testing. Subjects with Fontan palliation will undergo cardiac catheterization during exercise. The investigators hypothesize that invasive hemodynamic assessment during supine exercise will enable identification of early stage pulmonary vascular disease and diastolic dysfunction that is not apparent from invasive studies performed at rest.

Determine the role of rest-exercise echocardiography for the assessment hemodynamics in Fontan physiology. Transthoracic echocardiography will be performed at rest and during exercise simultaneously with catheterization in the subjects participating in Aim #1 to determine correlations between invasive and noninvasive hemodynamics and identify noninvasive alternatives to assess functional reserve.

Evaluate the clinical impact of pulmonary vascular disease and ventricular diastolic dysfunction. Multi-organ function and patient reported outcomes will be evaluated at baseline, 12 months (optional), and 24 months (optional) in subjects participating in Aims #1 and #2. The investigators hypothesize that subjects with poorer ventricular-vascular reserve will display more clinical and end-organ deterioration in longitudinal follow up.

Eligibility criteria: Inclusion Criteria:

* Fontan Palliation
* Age ≥18 years

Exclusion Criteria:

-No clinical indication for cardiac catheterization

Primary outcomes:
measure: Fontan Associated Liver Disease
timeFrame: 5 year
Secondary outcomes:
measure: Mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Alexander Egbe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02269137: Assessment of Severity and Prognosis for Patients With Status Epileptics(SE)
Official title: Assessment of Severity and Prognosis for Patients With Status Epileptics
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Status Epileptics
Keywords: status epileptics
prognosis
risk factor
outcome
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with status epilepticus

Brief summary: To characterize the functional outcomes and prognostic factors for convulsive status epilepticus (SE) and to further develop and validate a simple and practicable scoring system for outcome prediction.

Detailed description: 1. Retrospectively study all patients with convulsive SE treated between March, 2008, and November, 2014.
2. Develop a scoring system for outcome prediction.
3. Prospectively validate the predictive accuracy of the scoring system

Eligibility criteria: Inclusion Criteria:

* 30 min or more of (1) continuous clinical seizure activities or (2) recurrent seizure activities without recovery(returning to baseline)between seizures;
* clinical data is complete.

Exclusion Criteria:

* hypoglycemia SE;psychogenic SE;any other pseudo-SE

Primary outcomes:
measure: The modified Rankin scale
timeFrame: 3 months after discharge
Secondary outcomes:
measure: The modified Rankin scale
timeFrame: on discharge
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Department of Neurology, Xijing Hospital
state: Shaanxi
Study officials:
affiliation: The Department of Neurology, Xijing Hospital
name: Wen Jiang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02937337: Laryngeal Mask Airway With Video-stylet
Official title: Video Stylet Guided Laryngeal Mask Airway Insertion in Pediatrics: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia; Functional
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 108
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In this randomized controlled trial, we aimed to compare the efficacy of video-stylet guided laryngeal mask airway real time insertion technique with the standard recommended index finger-guided insertion technique in pediatric patients.

Detailed description: Compare the efficacy and safety of using video-stylet guided laryngeal mask airway insertion with blind technique

Eligibility criteria: Inclusion Criteria:

* pediatric patients undergoing general anesthesia using laryngeal mask airways

Exclusion Criteria:

* recent (within 2 weeks) upper respiratory infection

Primary outcomes:
measure: the time required for inserting the laryngeal mask airways
timeFrame: time interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
Secondary outcomes:
measure: the numbers of insertion attempt
timeFrame: interval between the caregiver picked up and put down the laryngeal mask airway an expected average of 30 seconds
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNUH
state: Jongro Gu
Study officials:
References:
Clinical trial NCT01974037: Capsaicin on Salty Gustatory Cortices
Official title: Effects of Capsaicin on Salty Gustatory Cortices in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Volunteers
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2013-11-01
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: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Excess dietary salt intake is closely associated with the development of hypertension and cardiocerebral vascular diseases. Preference of high salt diet might involve salty gustatory cortices change. This study focuses on examining the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.

Detailed description: Hypertension and its related complications are common health problems that can lead to multiple organ damage and death. Excessive salt intake plays an important role in the development of hypertension.

The experimental design is a randomized, double-blind, interventional study to investigate the neuroimaging changes of salty gustatory cortices under different concentration of NaCl solution with or without capsaicin intervention through brain PET/CT scan.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 65 years.
* Willing and able to provide written informed consent.
* Willing and able to comply with all study procedures.

Exclusion Criteria:

* High basic metabolic rate, tumor, epilepsia.
* Hypogeusia or loss due to neural system disease or oral and digestive disease.
* Capsaicin allergy and poor compliance.
* Recently oral diuretics and participate in other pharmacological experiment in 3 months.
* Acute infection, cancer, serious arrhythmias, drug or alcohol abuse.
* Currently have cold, fever, acidosis, dehydration, diarrhea, vomiting during the study.
* Unwilling or unable to communication due to the dysnoesia and language disorders.
* Severe neural or psychiatric diseases that would preclude fully understand and corporation in the study.
* History of allergic reaction attributed to 18F-FDG.
* Pregnancy or lactation.

Primary outcomes:
measure: Neuroimaging changes of salty gustatory cortices
timeFrame: 45min
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT03404037: Serum Endostatin Type 2 Diabetic Patients
Official title: Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients With Coronary Heart Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Coronary Artery Disease
Coronary Arteriosclerosis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2018-01-19
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: One hundred ten out documented CAD subjects were divided into two groups; group I (Fifty-five CAD patients without T2DM) and group II (Fifty-five CAD patients with T2DM) addmitted to Zagazig University hospital. Egypt

Brief summary: To assess the relationship between serum endostatin (ES) and Coronary artery calcification (CAC) in type 2 diabetic (T2DM) patients.

Detailed description: elevated serum endostatin levels were independently associated with increased risk, severity and progression of coronary artery calcification independent of traditional cardiovascular disease risk factors in T2DM subjects with known coronary artery disease. So, Measurement of serum ES levels can improve the diagnosis of coronary artery calcification and could be useful as a high sensitive marker for the presence and progression of atherosclerosis in T2DM patients.

Eligibility criteria: Inclusion Criteria: - Patients were between the ages of 50 and 70 years at enrollment.

* Symptomatic or previously recognized coronary artery disease for all the study population.
* Type 2 diabetic patients with the onset of type 2 diabetes occurred at age 30 years or older with no history of ketoacidosis for group II subjects.

Exclusion Criteria:

* left ventricular ejection fraction (LVEF) ≤40%, chronic heart failure, unstable angina, Myocardial infarction, arrhythmia, valvular heart disease, coronary artery bypass surgery, and history of stent placement, liver diseases, malignancy, glomerular filtration rate index \< 35 mL/min/m2, serum creatinine level above 4.5 mg/dL, body mass index \>30 kg/m2 or \< 15 kg/m2, pulmonary edema, stroke, acute infections, severe trauma, recent surgery, inflammatory conditions, thyrotoxicosis, pregnancy and known allergic reactions.

Primary outcomes:
measure: Serum Endostatin Level as a Marker for Coronary Artery Calcification in Type 2 Diabetic Patients with Coronary Heart Disease
timeFrame: 3-Months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of Medicine
Study officials:
affiliation: Faculty of medicine, Zagazig University
name: Hazem M Elashmawy, MD. Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01808937: Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
Official title: Immunologic and Genetic Profiles in Subsets of Morphea Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Scleroderma, Localized
Morphea
Frontal Linear Scleroderma en Coup de Sabre
Scleroderma, Circumscribed
Scleroderma, Linear
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 500
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment from clinic visits as well as from regional and national referrals.

Brief summary: The Morphea in Adults and Children (MAC) cohort is the first registry for both children and adults with morphea (also known as localized scleroderma) in the country. The purpose of the registry is to learn more about morphea, specifically:

* How morphea behaves over time
* How frequently specific problems occur along with morphea (for example, arthritis)
* Whether morphea has an autoimmune background


Eligibility criteria: Inclusion Criteria:

1. Patient must have a clinical diagnosis of morphea confirmed by the primary investigator and by histopathological examination.
2. Ages 0-90 years old
3. Children must weigh more than 20 lbs. in order to satisfy Children's Medical Center policy for the maximum amount of blood drawn in a 24 hour period.
4. Patient or legal guardian must be able to speak and read at a 6th grade reading level.
5. Both male and female patients will be eligible
6. All races and ethnic backgrounds will be included
7. Relationships to proband: All patients with morphea will be included. A patient's family history will be reviewed and if there is a family history of morphea or systemic sclerosis then we will give the study patient the investigator's contact information and ask the family member to call the study team to answer any questions and enroll them in the study if they choose to do so.
8. Ability to give informed consent: Patients must be able to give informed consent or they will give assent with parent or guardian consent as a minor to be a part of the morphea registry.

Exclusion Criteria:

- Patients who have been coded as morphea (701.0), but do not have morphea/localized scleroderma (examples: steroid atrophy, acquired keratoderma, keloids, nephrogenic fibrosing dermopathy, systemic sclerosis, lichen sclerosis)

Primary outcomes:
measure: Activity/damage measurement in morphea as scored on the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT)
timeFrame: 5 years
Secondary outcomes:
measure: Quality of life scores measured by the Dermatology Life Quality Index (DLQI)
timeFrame: 5 years
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center - Department of Dermatology
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Heidi Jacobe, MD, MSCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00884637: Correlation Between Visual Field Defects on FORESEE HOME and on Optical Coherence Tomography in Choroidal Neovascularization Subjects
Official title: Correlation Between Visual Field Defects on Home Macular Perimeter (FORESEE HOME) and on OCT in Eyes of Patients With CNV Before and After Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: HMP
CNV
AMD
PHP
HPHP
foresee home
Lead sponsor: Notal Vision Inc.
Sponsor class: INDUSTRY
First posted: 2009-04-21
Enrollment: 15
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects suspected to have CNV secondary to AMD in at least one eye

Brief summary: The FORESEE HOME is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee HOME demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.


Eligibility criteria: Inclusion Criteria:

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed with CNV
* Did not perform more then 4 anti- VGEF injections
* VA with habitual correction better then 6/45 in the study eye
* Ability to understand instructions
* Familiar with computer usage

Exclusion Criteria:

* Evidence of macular disease other than AMD or glaucoma in the study eye
* Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy,
* Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study

Primary outcomes:
measure: Size and location of lesions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Sorasky Medical Center
Study officials:
affiliation: Sorasky Medical Center
name: Anat Loewenstein, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260137: Comparison of Two Different Methods for Reducing Pain After Lung Surgery
Official title: Comparison of the Effectiveness of the Combination of Rhomboid Intercostal and Sub-serratus Plan Block and Rhomboid Intercostal Block for Postoperative Analgesis in Video-assisted Thoracopic Surgery (VATS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Analgesia
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is:

Which of these two blocks more effectively reduces the patients' pain?


Eligibility criteria: Inclusion Criteria:

* Patients in American Society of Anesthesiologists (ASA) classes I, II and III for whom VATS is planned

Exclusion Criteria:

* Known or suspected local anesthetic allergy
* coagulopathy
* injection site infection
* history of thoracic surgery
* serious neurological or psychiatric disorder
* severe cardiovascular disease
* liver failure
* renal failure

Primary outcomes:
measure: Postoperative analgesia
timeFrame: first 48 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Hastane
Study officials:
References: