louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04557033: My Mindful Moments: A Mindfulness Meditation and Digital Art Activity
Official title: My Mindful Moments: A Mindfulness Meditation and Digital Art Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Meditation
Keywords: Mindfulness
Meditation
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this evidence-based practice project is to evaluate the feasibility of providing a relaxation mindfulness meditation and an expressive digital arts activity among clinical staff at Dana Farber Cancer Institute .

Detailed description: This project provides an opportunity for patient care staff in an ambulatory oncology setting to participate in and evaluate an activity that includes a mindfulness meditation technique and an expressive digital arts activity.

This study will be conducted to evaluate the feasibility of providing a mindfulness meditation and digital imagery activity.

* The activity will include a guided mindfulness meditation and the creation of a digital image on an iPad.
* Participants will be asked to complete brief surveys before and after the intervention activity.

Eligibility criteria: Inclusion Criteria:

* Adults ≥18 years of age
* Currently employed at Dana Farber Cancer Institute
* Providing patient care on Yawkey

Exclusion Criteria:

* Not an employee of Dana Farber Cancer Institute
* Not providing Patient Care on Yawkey

Primary outcomes:
measure: Percentage of Participation-Feasibility
timeFrame: 1 year
measure: Percentage Completion of Full Activity-Feasibility
timeFrame: 1 year
measure: Mean Completion Time-Feasibility
timeFrame: 1 year
Secondary outcomes:
measure: Change in Anxiety Score
timeFrame: 1 Year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Terri Jabaley, Ph.D, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681533: Epicardial Adipose Tissue and Arterial Stiffness in People Living With Diabetes (METAB-CV-PWV)
Official title: Tissu Adipeux épicardique et rigidité artérielle Chez Les Personnes Vivant Avec un diabète
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Patients
Keywords: Diabet
arterial stiffness
pericardial adipose tissue
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 or 2 diabetic patients who perform coronary calcium score measurement by CT scan and pulse wave velocity assessment as part of their routine care practice.

Brief summary: The present study is a retrospective and prospective current care cohort that will allow us to evaluate the relationship between epicardial fat volume and increased arterial stiffness in a person living with diabetes.

Detailed description: Epicardial adipose tissue is considered as the cardiac visceral fat and is associated with increased cardiovascular risk, for example in diabetes. Thus, the mechanisms involved seem to be related to myocardial lipotoxicity; atherosclerosis in connection with inflammation and secretion of proinflammatory factors such as cytokines but also insulin resistance.

In this context, the investigators hypothesize that epicardiac adipose tissue volume will be higher in patients with increased arterial stiffness than in those without. In this study, the investigators will then try to verify the existence of a relationship between pericardial adipose tissue volume and increased arterial stiffness in people living with diabetes.

To do this, the investigators will analyze the results of measurements of pericardial fat volume, coronary calcium score, and pulse wave velocity in diabetic patients.

Eligibility criteria: Inclusion Criteria:

Patients will be eligible for participation in the study if:

* They are informed and have not objected to participating in the research.
* They have type 1 or 2 diabetes.
* They perform a coronary calcium score measurement by CT scan and a pulse wave velocity assessment during their routine care practice.

Primary outcomes:
measure: Epicardial fat volume
timeFrame: the inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Bobigny
country: France
facility: endocrinologie site, Avicenne hospital
Study officials:
affiliation: APHP, Hospital Avicenne
name: Emmanuel COSSON, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02001233: A Follow-up Study for a Phase III, Efficacy Trial in Inactivated Enterovirus Type 71 (EV71) Vaccine
Official title: An Open-labelled, Multicentered, Follow-up Study for a Phase III, Efficacy Trial to Evaluate the Two-year Efficacy, Safety, and Immune Persisitence of Inactivated Enterovirus Type 71 (EV71) Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hand, Foot and Mouth Disease
Keywords: EV71 vaccine
EV71-associated HFMD
efficacy
safety
immune persistence
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-12-04
Enrollment: 10077
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Chinese infants aged 6 to 35 months old

Brief summary: The purpose of this follow-up study is to evaluate the two-year efficacy, immunogenicity and safety of EV71 Vaccines in preventing Hand, Foot and Mouth disease caused by EV71 in a total 10,000 healthy infants volunteers aged from 6 to 35months old.

Detailed description: The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed on March 2013 in China. The data from the phase III study suggested that the inactivated EV71 vaccine had protection effects on healthy Chinese infants against Hand, Foot and Mouth disease caused by EV71 within one-year surveillance period, and had clinically acceptable safety and good one-year immune persistence.

This study is the phase III, open-labelled, follow-up research, in order to evaluate the two-year efficacy, safety and immune persistence.

Eligibility criteria: Inclusion Criteria:

* All subjects vaccinated at least one injection of EV71 vaccine or the placebo in the phase III efficacy trial.

Exclusion Criteria:

* subjects who refuse to continue in the study.

Primary outcomes:
measure: The incidence rate of Hand, Foot and Mouth disease caused by EV71 within the second year observation period after the second vaccination
timeFrame: Within the second year after the second vaccination
Secondary outcomes:
measure: The GMT of anti-EV71 antibodies in serum two years after second vaccination
timeFrame: 26 months after second vaccination
measure: Frequency of serious adverse events (SAEs) with the second year after the second vaccination
timeFrame: within the second year after the second vaccination
Other outcomes:
Locations:
city: Lianyungang
country: China
facility: Ganyu
state: Jiangsu
city: Taizhou
country: China
facility: Taixing
state: Jiangsu
city: Yancheng
country: China
facility: Sheyang
state: Jiangsu
Study officials:
affiliation: Jiangsu Center for Diseases Control and Prevention
name: Feng-Cai Zhu, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06711133: Multimodal Ultrasound in Peripheral Neuropathy
Official title: Role of Multimodal Ultrasonography in Evaluation of Peripheral Neuropathy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Neuropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinical data of peripheral neuropathy who can cooperate to do the procedure not mentally retarded and healthy skin texture .

Brief summary: This study will enforce the role of ultrasound in early diagnosis and screening on peripheral neuropathy in comparison with other modalities.

Detailed description: Each case will undergo informed Written consent and will be told the aim of the study including benefits, no harm from this procedure to the participants.

Eligibility criteria: Inclusion Criteria:

* patients with clinical symptoms of peripheral neuropathy

Exclusion Criteria:

* patients with unhealthy tissue texture to put on probe

Primary outcomes:
measure: The Role of multimodal ultrasonography in evaluation of peripheral neuropathy
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Telleman JA, Herraets IJ, Goedee HS, van Asseldonk JT, Visser LH. Ultrasound scanning in the diagnosis of peripheral neuropathies. Pract Neurol. 2021 Jun;21(3):186-195. doi: 10.1136/practneurol-2020-002645. Epub 2021 Feb 4.
Clinical trial NCT02109133: The Impacts of Surgical Visibility Through Deep Neuromuscular Blockade on Intraocular Pressure in Patients Undergoing Robot-Assisted Laparoscopic Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Robot-Assisted Laparoscopic Radical Prostatectomy
Keywords: deep neuromuscular blockade
intraocular pressure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 67
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Intraocular pressure is significantly increase during robot-assisted laparoscopic radical prostatectomy which is performed in a steep trendelenburg position at prolonged times of pneumoperitoneum. Therefore investigators decided to evaluate the impacts of surgical visibility through deep neuromuscular blockade on intraocular pressure in patients undergoing Robot-Assisted Laparoscopic Radical Prostatectomy.


Eligibility criteria: Inclusion Criteria:

1. ASA class I-II
2. obtaining written informed consent from the parents
3. aged over 50 years who were undergoing robot- assisted laparoscopic prostatectomy

Exclusion Criteria:

1. eye surgery previously
2. unstable angina or congestive heart failure
3. concomitant eye disease (glaucoma, diabetic retinopathy, cataract, retinal detachment)
4. high intraocular pressure over 30mmHg after screening test.
5. uncontrolled hypertension (diastolic bp\>110mmHg)
6. coagulopathy
7. asthma
8. hepatic failure
9. renal failure(creatinine clearance \< 30 ml/min)
10. drug hyperactivity
11. neurological or psychiatric illnesses
12. mental retardation
13. patients who can't read the consent form due to illiterate or foreigner
14. previous malignant hyperthermia Hx
15. drug medication which interact with muscle relaxant (anti-convulsant, certain antibiotics, magnesium etc)
16. BMI \> 30kg/m2

Primary outcomes:
measure: Maximum Intraocular Pressure During RALRP Under Deep Neuromuscular Blockade
timeFrame: Maximum intraocular pressure was measured at 60 minutes after CO2 pneumoperitoneum in the ST position
Secondary outcomes:
measure: Overall Surgical Condition
timeFrame: At the end of the Steep trendelenburg position, an average of 1 hour
Other outcomes:
measure: Post-operative Nausea
timeFrame: During 24hours after operation
measure: Incidence of Residual Neuromuscular Blockade
timeFrame: During 24hours after operation
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Yoo YC, Kim NY, Shin S, Choi YD, Hong JH, Kim CY, Park H, Bai SJ. The Intraocular Pressure under Deep versus Moderate Neuromuscular Blockade during Low-Pressure Robot Assisted Laparoscopic Radical Prostatectomy in a Randomized Trial. PLoS One. 2015 Aug 28;10(8):e0135412. doi: 10.1371/journal.pone.0135412. eCollection 2015.
Clinical trial NCT01460433: Problems With Immune Recovery in the Gut Tissue
Official title: A Compartmental Analysis of HIV Reservoirs and Immune Reconstitution (C)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: HIV 1
Herpes Simplex Type 2
Treatment experienced
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2011-10-26
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV+, antiretroviral-treated individuals who have been exposed to Herpes Simplex Type 2 and Cytomegalovirus and HIV- individuals who have been exposed to Herpes Simplex Type 2 and Cytomegalovirus.

Brief summary: The aim of this study is to find out if the process of HIV replication in the lymph tissue and gut tissue of people taking HIV drugs causes long-term damage to the ability of the gut to protect you from other infections and health problems.


Eligibility criteria: Inclusion Criteria:

HIV+ individuals

* Seropositive for HIV
* On ART for at least 12 months
* Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
* Age ≥ 18 years
* Negative pregnancy test for eligible women of childbearing potential

HIV- individuals

* Seronegative for HIV
* Seropositive for Herpes Simplex Type 2 and Cytomegalovirus
* Age ≥ 18 years
* Negative pregnancy test for eligible women of childbearing potential

Exclusion Criteria:

* Taking daily suppressive therapy for Herpes Simplex Type 2
* Contraindication to surgical \& endoscopic procedures (as judged by PI)
* Psychiatric or psychological illness that would make adherence to protocol procedures unlikely
* Pregnancy

Primary outcomes:
measure: Herpes Simplex Virus - Type 2 shed rate
timeFrame: 60 days
Secondary outcomes:
measure: Evidence of HIV replication in blood and lymphoid tissue
timeFrame: 60 days
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Timothy Schacker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00617487: Pulmonary Arterial Hypertension in Systemic Sclerosis
Official title: Stress Echocardiography in the Early Identification of Pulmonary Arterial Hypertension in Systemic Sclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Sclerosis
Pulmonary Arterial Hypertension
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2008-02-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with systemic sclerosis

Brief summary: The purpose of this study is to evaluate the role of stress echocardiography, compared to standard echocardiography in the early identification of pulmonary arterial hypertension in systemic sclerosis. To evaluate the role of BNP in this setting.To analyze data recorded with respect to the parameters commonly used for SSc evaluation (eg thorax HRCT, pulmonary function tests + DLCO, nailfold capillaroscopy, etc); these parameters are available starting for 1999.


Eligibility criteria: Inclusion Criteria:

* Patients with systemic sclerosis according to LeRoy criteria

Exclusion Criteria:

* Pregnancy
* Significant valvular disease
* Low left ventricular function upon echocardiography (ejection fraction\<55%)
* History of atrial fibrillation, myocardial infarction, pulmonary thromboembolisms, neoplasia or severe hepatic disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS Foundation Policlinico S. Matteo
state: PV
city: Pavia
country: Italy
facility: IRCCS Policlinico S. Matteo
state: PV
Study officials:
affiliation: IRCCS Foundation Policlinico S. Matteo, Cardiology
name: Stefano Ghio, MD
role: STUDY_DIRECTOR
affiliation: University and IRCCS Foundation Policlinico S. Matteo, Rheumatology
name: Lorenzo Cavagna, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cavagna L, Caporali R, Klersy C, Ghio S, Albertini R, Scelsi L, Moratti R, Bonino C, Montecucco C. Comparison of brain natriuretic peptide (BNP) and NT-proBNP in screening for pulmonary arterial hypertension in patients with systemic sclerosis. J Rheumatol. 2010 Oct;37(10):2064-70. doi: 10.3899/jrheum.090997. Epub 2010 Jul 15.
Clinical trial NCT04422587: Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea
Official title: Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergencies
Keywords: COVID-19
diagnostic strategy
acute dyspnea
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 1860
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patient admitted to the RECOP unit for dyspnea will be inclued in this clinical trial

Brief summary: This research aims to improve our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out.

A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However, virological tests do not currently allow rapid results for COVID-19.

Research project of investigatory aims to develop a predictive model of the risk of being COVID-19 positive for patients admitted to the emergency room for acute dyspnea.


Eligibility criteria: Inclusion Criteria:

* All patients over 15 years admitted to the RECOP unit for dyspnea

Exclusion Criteria:

* Patient admitted to shock for respiratory distress requiring immediate respiratory support.
* Patient under justice safeguard

Primary outcomes:
measure: Develop a predictive model of the risk of being COVID-19 for patients admitted to the emergency room for dyspnea
timeFrame: inclusion day
Secondary outcomes:
measure: Describe the characteristics of patients admitted to reCOP units according to their virological status
timeFrame: 30 days
measure: Virological status
timeFrame: 30 days
measure: Mortality status
timeFrame: 30 days
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
affiliation: University Hospital of Toulouse
name: Paul-Henri Auboiroux, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03763487: The Aim of This Project is to Verify Whether a Depletion of B Cell Memory Subpopulation ("Marginal-zone-like") CD19 + IgD + CD27 + and CD19 + IgM + CD27 + is a Useful Indicator of Hyposplenism in Patients With Celiac Disease
Official title: Marginal Zone Similar to B Lymphocytes in Peripheral Blood in Patients With Celiac Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Celiac Disease
Keywords: celiac sprue, celiac, hyposplenism, IgM memory, B lymphocytes
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 50 patients and 30 healthy blood donor
Primary purpose: DIAGNOSTIC

Brief summary: This project is expected to confirm the hypothesis that hyposplenism in patients with celiac disease is not conditioned by a selective memory deficiency of B lymphocytes.

Other objectives of project are:

* determination of gliadin 33-mer in faecal and urine as indicators patient´s adherence to gluten-free diet
* determination of citrulline in plasma as an indicator of the overall functional capacity enterocytes

Detailed description: Ultrasound examination is focused to spleen size (spleen volumetry). Methodology of laboratory examinations is based on venous blood sampling for the determination of memory B-like marginal zone by flow cytometry; gliadin 33-mer (ELISA) determination in faecal and urine sample; blood plasma extraction for citrulline (high performance liquid chromatography, HPLC).

Eligibility criteria: Inclusion Criteria:

* diagnosed celiac disease
* age over 18 years

Exclusion Criteria:

* haematological diseases and cancer
* infectious and non-infectious inflammation of the small intestine
* congenital or acquired immunodeficiency
* autoimmune disease
* immunosuppressant treatment
* diabetes mellitus
* pregnancy and lactation

Primary outcomes:
measure: concentration of B-lymphocytes as parameter to evaluate treatment effect
timeFrame: one year
measure: concentration of B-lymphocytes as parameter to evaluate treatment effect
timeFrame: one year
measure: concentration of citrullin in plasma as parameter to evaluate treatment effect
timeFrame: one year
measure: concentration of ornithin in plasma as parameter to evaluate treatment effect
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Králové
country: Czechia
facility: University Hospital Hradec Králové
state: The Czech Republic
Study officials:
References: