louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05746312: Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community
Official title: A Digital Music-based Mindfulness Intervention for Elevated Race-based Anxiety in the Black Community: a Replication and Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Lead sponsor: Harvard University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We recruited 8 Black American adults to participate in this multiple baseline study. In a multiple-baseline design, one takes repeated measurements of one's outcomes of interest across time, and subsequently compares these outcomes of interest between an initial baseline control period with no intervention and a subsequent intervention period. This is a within-subjects study design for which participants serve as their own control.
Primary purpose: TREATMENT

Brief summary: This study uses a multiple-baseline design and aims to replicate findings that a digital music-based mindfulness intervention can reduce elevated race-based state anxiety in Black Americans.


Eligibility criteria: Inclusion Criteria:

* Familiarity with meditation
* Turns to music for emotional support
* Elevated trait anxiety (\>=12 on the State Trait Anxiety Inventory - Trait \[STAIT\]-5)
* Majority of anxiety comes from racism or discrimination (\>=60 on a scale of 0 \[not at all\] to 100 \[entirely\] for the following question; "If you are a racial or ethnic minority, how much do you feel that racism and/or discrimination contribute to your elevated anxiety levels?")."

Exclusion Criteria:

-

Primary outcomes:
measure: State anxiety
timeFrame: Duration of study visit (60-90 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Harvard University
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Grant Jones
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02742012: Validation of a Multimodal Indicator of Depth of Anesthesia
Official title: A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: electroencephalogram
hemodynamic monitoring
respiratory monitoring
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 adult patients scheduled for elective surgery under general anesthesia

Brief summary: The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28).

The indicator previously developed shall now be tested on an independent set of data.

The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers.

The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* elective surgery under general anesthesia
* anticipated operating time of about one hour or longer
* ASA physical status I-III
* written informed consent

Exclusion Criteria:

* chronic intake of CNS affecting drugs
* alcohol or drug abuse in the last three months
* CNS or psychiatric disease
* hardness of hearing or deafness
* abnormal gastrointestinal motility
* non-adherence to fasting guidelines, emergency surgery
* anticipated difficult airway
* pregnancy
* cardiac surgery and surgery involving the head and/or neck
* postoperatively prolonged intubation
* pre- and/or postoperative intensive care treatment

Primary outcomes:
measure: ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness
timeFrame: 1 minute
Secondary outcomes:
measure: the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia
timeFrame: 1 minute
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Klinik für Anästhesiologie
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Department of Anesthesiology
city: Wuppertal
country: Germany
facility: Klinik für Anästhesiologie am Helios Klinikum
Study officials:
affiliation: Klinikum rechts der Isar Technische Universität München
name: Eberhard F Kochs, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05885412: A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediated Arrhythmogenic Cardiomyopathy (PKP2-ACM)
Official title: A Phase 1 Dose Escalation Trial Evaluating an Intravenously Administered Recombinant Adeno-Associated Virus Serotype rh.74 (AAVrh.74) Vector Containing the Human Plakophilin-2a (PKP2a) Coding Sequence (RP-A601; AAVrh.74-PKP2a) in Subjects With Arrhythmogenic Cardiomyopathy Arising From Pathogenic PKP2 Variants (PKP2-ACM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)
Keywords: Arrhythmogenic cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathy
Arrhythmogenic Right Ventricular Dysplasia
Sudden Cardiac Death
Genetic cardiomyopathy
Gene therapy
PKP2
ARVC
ARVD
ACM
Cardiac Arrest
Ventricular Arrhythmia
Lead sponsor: Rocket Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-02
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This Phase 1 dose escalation trial will assess the safety and preliminary efficacy of a single dose intravenous infusion of RP-A601 in high-risk adult patients with PKP2-ACM.


Eligibility criteria: Key Inclusion Criteria:

1. Male or female ≥18 years at the time of signing the informed consent
2. Capable and willing to provide signed informed consent
3. Clinical diagnosis of ACM as defined by the 2010 revised Task Force Criteria (TFC)
4. Documentation of a pathogenic or likely pathogenic truncating variant in PKP2
5. History of Implantable Cardioverter-Defibrillator (ICD) implantation ≥6 months prior to enrollment
6. PVC frequency ≥500 per 24 hours by ambulatory rhythm monitoring
7. Left ventricular ejection fraction by echocardiogram or CMR ≥50%

Key Exclusion Criteria:

1. Anti-AAVrh.74 capsid neutralizing antibody titer of \>1:40
2. Cardiomyopathy related to a genetic etiology other than PKP2 truncating variant
3. Previous participation in a study of gene transfer or gene editing
4. Severe Right ventricular (RV) dysfunction
5. New York Heart Association (NYHA) Class IV heart failure.

Primary outcomes:
measure: Evaluation of safety associated with RP-A601
timeFrame: 12 months post-infusion
Secondary outcomes:
measure: Preliminary efficacy of RP-A601 - Myocardial PKP2 protein expression
timeFrame: 12 months post-infusion
measure: Preliminary efficacy of RP-A601 - Ventricular ectopy and arrhythmia
timeFrame: 12 months post-infusion
measure: Preliminary efficacy of RP-A601 - Cardiac biomarkers
timeFrame: 12 months post-infusion
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of California, San Diego
name: Barry Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03284112: Old SCHOOL Hip-Hop: Improve Alzheimer's Disease Knowledge
Official title: Old SCHOOL Hip-Hop: A Randomized Controlled Trial to Improve Alzheimer's Disease Knowledge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Dementia, Schools, Nutrition, Health
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2017-09-15
Enrollment: 2244
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to evaluate the knowledge of parents and children with respect to dementia symptoms, risk factors, and response before and after an interactive dementia education program that uses music and dance to enhance a health education curriculum at 1-week and 3-months after the intervention.

Detailed description: Public awareness of Cardinal Alzheimer's disease (AD) symptoms remains low. Adults often underestimate personal dementia risk; minority populations are more likely to have low dementia literacy and be unaware of it. Cultural dementia belief in minority groups are complex and pose barriers to diagnosis, with dementia symptoms being considered a part of normal aging, or that discussion may be taboo even when recognized. A key barrier to timely AD diagnosis in African Americans is delayed physician contact, often years-long, following the onset of first symptoms. Despite studies demonstrating that dementia concepts first develop in elementary school periods, apart from our work, no dementia awareness programs focus on children. This intervention therefore addresses a major gap regarding optimal approaches for shifting cultural perceptions of dementia in low-income minority populations and reducing barriers to its timely diagnosis.

All R01 aims have been completed in this study.

Eligibility criteria: Inclusion Criteria:

* 4th and 5th-grade children (ages 9-11y) and their parents (age \> 20 years).
* Selected New York City public schools with similar socio-demographic composition.

Exclusion Criteria:

* Schools have already received pilot OSHH and the U.S. Department of Health and Human Services (HHS) programming.

Primary outcomes:
measure: Change in Dementia Symptom and Response Knowledge Assessment Score
timeFrame: Baseline, 1 week, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Neurology
name: James Noble, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01287312: Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
Official title: Trichloroacetic Acid for Endoscopic Tracho-esophageal Fistula Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tracheo Esophageal Fistula
Keywords: We will treat children age 1 month to 20 years with recurrent TEF after surgical failure
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-02-01
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.

The investigators want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Detailed description: Today Endoscopic repair of recurrent Tracheesophageal fistula (TEF) is a safe procedure. Using Trichlosiacetic acid 50% (TCA) for endoscopic aplication of the fistula was reported with a good results ( 4 cases). There were no serious advers effects.

We want to use also TCA 50% for endoscopic repair in children with recurrent TEF.

Eligibility criteria: Inclusion Criteria:

* children age 1 month- 20 years old with recurrent TEF.
* Failure of surgical repair.

Primary outcomes:
measure: Closure of the fistula
Secondary outcomes:
measure: clinical and pulmonary improvment
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT05787912: Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy
Official title: Efficacy of Hyaluronic Acid Gel and Photobiomodulation on Wound Healing After Surgical Gingivectomy: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Enlargement
Keywords: Surgical gingivectomy
Hyaluronic acid
Photobiomodulation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effect of hyaluronic acid gel after photobiomodulation on the healing of surgical gingivectomy sites


Eligibility criteria: Inclusion Criteria:

* Chronic inflammatory gingival enlargement grade 2 and 3 according to the gingival overgrowth index by Miller and Damn.
* Adequate amount of keratinized tissue.
* Attachment loss= 0
* Well educated patients as post-operative instructions need to be followed precisely.

Exclusion Criteria:

* Patients with history of smoking
* Pregnant women
* Patients with bad oral hygiene
* Patients who have any known systemic disease that interfere with performance of surgical gingivectomy or periodontal wound healing
* Patients who have any previous adverse reactions to the products (or similar products) used in this study

Primary outcomes:
measure: Wound healing
timeFrame: up to 21 days
measure: Perceived pain
timeFrame: up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Basma K Yacout, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Fatma R Kamel, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Maha A Abou Khadr, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Pharmacy, Alexandria University
name: Lamia A Heikal, PhD
role: STUDY_DIRECTOR
affiliation: Alexandria University
name: Gillan I El-Kimary, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04226612: Association of Inpatient Blood Pressure Levels With In-hospital Adverse Events(APPLE Study)
Official title: Association of Inpatient Blood Pressure Levels With In-hospital Adverse Events(APPLE Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Keywords: Blood Pressure
Inpatient
Adverse Events
All-cause mortality
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 100000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatient

Brief summary: The purpose of the study is to investigate the association between inpatient blood pressure levels and in-hosopital adverse outcomes.

Detailed description: Study population includes subjects who are hospitalized due to illness, of any race or ethnicity, any of age.The primary outcome is all-cause mortality occured in the hospital.

Eligibility criteria: Inclusion Criteria:

* Inpatient with all age or race;
* Have blood pressure data.

Exclusion Criteria:

* Non-patients；
* Death outside the hospital；
* Missing blood pressure data.

Primary outcomes:
measure: All-cause mortality
timeFrame: during the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Feng Ying-qing
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Feng Ying-qing, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04508712: Long-term Outcomes in Patients With COVID-19
Official title: Long-term Outcomes in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
long-term outcomes
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll survivors of COVID-19 aged over 18 years old who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China.

Brief summary: Long-term outcomes from coronavirus disease 2019 (COVID-19) are currently unknown. This study will collect daily living status of survivors of COVID-19.

Detailed description: The ongoing pandemic of coronavirus disease 2019 (COVID-19), due to the newly discovered severe acute respiratory syndrome coronavirus 2 (SAR-CoV-2), has caused a worldwide increase in hospitalization for pneumonia with multi- organ disease. Survival from sepsis is associated with increased risk for mortality for at least 2 years. Therefore, substantial sequelae including new physical disability, new cognitive impairment and increased vulnerability to further health deterioration are likely to be seen in survivors of COVID-19. The investigators conduct this study to investigate daily living status of survivors of COVID-19 using telephone interview questionnaire including Activity Daily Living(ADL), modified Medical Research Council(mMRC),modified Telephone Interview for Cognitive Status (TICS-m), Zung Self-rating Depression Scale(SDS), Carcinologic Handicap Index (CHI), and New York Heart Association (NYHA) functional class.

Eligibility criteria: Inclusion Criteria:

* Survivors who had been admitted in Leishenshan Hospital for COVID-19 patients in Wuhan, China

Exclusion Criteria:

* Patients who were \< 18 years

Primary outcomes:
measure: Physical functions
timeFrame: 4-6 months
measure: Respiratory function
timeFrame: 4-6 months
measure: Cognitive function
timeFrame: 4-6 months
measure: Depression status
timeFrame: 4-6 months
measure: Sensory functions
timeFrame: 4-6 months
measure: Heart function
timeFrame: 4-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pudong
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiaotong University, China
name: Weifeng Yu, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05356312: Glioblastoma and Individualized Therapies
Official title: Retrospective Analysis of Glioblastoma Patients With Immune Therapies
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Glioma, Malignant
Lead sponsor: Zentrum fur Humangenetik Tuebingen
Sponsor class: OTHER
First posted: 2022-05-02
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The treatment of patients with World Health Organization (WHO) grade 4 malignant glioma has not seen any significant breakthrough the past years. Following surgery and radio / chemotherapy patients still experience a very high recurrence risk and the prognosis is dismal. The investigators observed patients with grade IV malignant glioma receiving individualized treatment based on their molecular profile including fully personalized vaccines.


Eligibility criteria: Inclusion Criteria:

* malignant glioma, IDH WT

Exclusion Criteria:

* na

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Zentrum für Humangenetik Tübingen
Study officials:
References:
Clinical trial NCT00155012: Clinical Application of MDCT in Coronary Artery Disease
Official title: Clinical Application of 16-Detector Row Computed Tomography in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Arteriosclerosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: 1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.

Detailed description: Computed tomography is evolving as a tool for noninvasive diagnosis of coronary artery disease. Coronary calcium deposition amount is an established independent coronary artery disease risk factor. However, coronary artery stenosis seldom occurred in the same location as calcium deposition. With the advent of 16-detector-row multislice spiral CT, direct visualization of coronary artery is possible. But it remains a great challenge to obtain diagnostic quality image in the beating heart. Small distal vessels may not be adequately visualized. Artifacts from severe calcification or coronary stent may render diagnosis difficult. The clinical implication of coronary calcium score, indication of coronary CT angiography and myocardial enhancement measurement should be further studied. The purposes of this study are: 1) Establish normal value for coronary calcium scoring in Taiwan. 2) Find out the relationship of coronary calcium deposition and coronary artery stenosis. Propose a clinical management guideline based on coronary calcium score. 3) Evaluate sensitivity/specificity of coronary CT angiography and the influence of coronary calcium score on coronary CT angiography. 4) Evaluate the clinical application of myocardial enhancement measurement.

Eligibility criteria: Inclusion Criteria:

* coronary artery disease admitted for coronary angiography

Exclusion Criteria:

* Heart failure, irregular heart rate

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wen-jeng Lee, M.D.
role: STUDY_DIRECTOR
References: