louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04781803: Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome
Official title: Cyclosporine on Day Zero as Prophylaxis for Cytokine Release Syndrome in Outpatient Haploidentical Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stem Cell Transplant Complications
Cytokine Release Syndrome
Keywords: Cyclosporin
Haploidentical
Outpatient
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 32
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Phase II, randomized controlled, unblinded clinical trial. Will evaluate whether the administration of oral cyclosporine started on day 0 of transplantation is effective in reducing the incidence of cytokine release syndrome (CRS) in patients who receive an outpatient haploidentical transplant.

Detailed description: CRS is usually limited after the administration of post-transplant cyclosporine (PT-CsA) administered on days +3 and +4, however, there is no standard prevention or treatment regimen for CRS after haplo-TCPH and therapeutic behavior has usually been adopted.

Sample of 32 patients between the ages of 16 and 60 who receive their first haploidentical transplant at our center. In the control group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day +5 of the transplant, mycophenolic acid 1 gram orally (2 tablets of 500 mg) from day +5 post-transplant and post-transplant cyclophosphamide (PT-CY) at 50 mg/kg per day on days +3 and +4 and in the experimental group, CsA 6 mg/kg orally divided into two doses per day starting in the morning on day 0 after transplantation, mycophenolic acid 1 gram orally (2 tablets 500 mg) from day 0 post-transplant and PT-CY at 50 mg/kg per day on day +3 and +4.

Will document the presence of CRS and its degree, as well as the need for hospitalization, associated infectious processes, and a day to recover neutrophils and platelets. Additionally, 4 blood samples will be taken from the patients to determine the level of cytokines and C-reactive protein.

Eligibility criteria: Inclusion Criteria:

* Patients between 16-60 years of age who receive their first haploidentical transplant.

Exclusion Criteria:

* Patients positive for the human immunodeficiency virus (HIV), Hepatitis B or C virus
* Pregnancy or lactation
* Patients with documented infection at the time of transplantation
* Presence of previous autoimmune diseases
* Inability to tolerate the oral route

Primary outcomes:
measure: Cytokine Release Syndrome
timeFrame: day 0 to day 30
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. José E. González, Centro Universitario contra el Cáncer
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario ¨Dr. José Eleuterio González
name: Oscar González-Llano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06025903: Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis
Official title: Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: multiple sclerosis
mitochondria
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
Collaborators: name: Azienda Socio Sanitaria Territoriale della Valle Olona
First posted: 2023-09-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients will be recruited from primary care clinic

Brief summary: The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Specific aims are: 1) identify mitochondrial-related pathways, inherited and somatic mitochondrial DNA mutations associated to primary progressive multiple sclerosis, 2) functionally assess the identified genetic alterations.

Detailed description: Multiple Sclerosis is a major cause of neurological disability, with a high socio-economic impact that increases as disability progresses. Effective treatment of primary progressive multiple sclerosis is still an unmet need and the underlying neurodegenerative processes have to be fully investigated. The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Altered mitochondrial pathways will be investigate, as well as inherited and tissue-specific somatic mitochondrial variations associated with primary progressive multiple sclerosis.

Eligibility criteria: Inclusion Criteria:

* Patients affected by primary progressive or relapsing remitting multiple sclerosis
* Patient able to provide informed consent

Exclusion Criteria:

* Individuals with \< 18 years
* Patients not affected by primary progressive or relapsing remitting multiple sclerosis

Primary outcomes:
measure: sequencing of mitochondrial DNA
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
state: MI
city: Gallarate
country: Italy
facility: ASST della Valle Olona - Ospedale di Gallarate
state: VA
Study officials:
affiliation: IRCCS San Raffaele
name: Melissa Sorosina
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608503: Lung Deflation in Pediatric Subclavian Vein Catheterization
Official title: The Effect of Lung Deflation on the Position of the Pleura in Mechanically Ventilated Infants During Subclavian Vein Cannulation: an Ultrasound Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Subclavian Vein Catheterization
Keywords: subclavian vein
ultrasound
distance between the subclavian vein and the lung
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-05-31
Enrollment: 41
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The subclavian vein (SCV) is a preferred site for placement of central venous catheter. However, pneumothorax is a major concern during subclavian venous catheterization. Lung deflation, by decreasing lung volume, may reduce the risk of pneumothorax by increasing the distance between the pleura and the SCV. The investigators evaluated the effect of lung deflation on the relative position between the pleura and the line of the imaginary needle pathway during supraclavicular and infraclavicular approach to the subclavian vein (SCV) using ultrasonography.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients who were scheduled for elective operation under general anesthesia
* Neonates (0 \~ 1 mo), Infants (1 mo \~ 1 yr)

Exclusion Criteria:

* Structural anomalies of the chest wall
* History of lung and chest wall operations
* Prior central venous catheterization
* Upper respiratory tract infection, or pneumonia within 2 weeks

Primary outcomes:
measure: The distance between the pleura and the line of the imaginary needle pathway (DPI)
timeFrame: Within 5 minutes
Secondary outcomes:
measure: The incidence of pleural movement over the imaginary needle pathway
timeFrame: Within 5 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
Study officials:
References:
Clinical trial NCT06191003: Urdu Version of Maastricht Upper Extremity Questionnaire Reliability Validity Study.
Official title: Analysis of Urdu Version of Maastricht Upper Extremity Questionnaire: A Reliability and Validity Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani computer user's population with complaint of arm, neck, shoulder (CANS) was included in this study.

Brief summary: In this study, the examiners will investigate the reliability and validity of Mastrict Upper Extremity scale in Urdu language in Pakistani patients with Carpal tunnel syndrome.

Detailed description: The objective of this study is to translate as well as culturally adapt the Mastrict Upper Extrimity scale (MUEQ) into Urdu language and to test its reliability and validity in patients with Carpal Tunnel Syndrome. This cross-sectional survey will use convenience sampling technique to enroll the participants on a pre-defined criteria.

The outcomes of this study will help in finding the reliability and validity of MUEQ in patients with CTS. The reliability of this scale will be examined using internal consistency and test-retest methods. The internal consistency will be checked by Cronbach's alpha value. The test-retest reliability will be analyzed using an interclass correlation with patients.

Eligibility criteria: Inclusion Criteria:

* Individuals who had to execute computer jobs in office.
* Individuals who have been working in present position for minimum 6 months
* Individuals who have been working for at least 4 hours or more in a day

Exclusion Criteria:

* Individuals who had Severe phsycytric and behavioral complaint
* Individuals who had prior injury of upper extremity
* Individuals who had any surgery of upper extremity

Primary outcomes:
measure: Visual Analouge scale
timeFrame: 12th week
measure: JAMAR Hydraulic hand Dynamometer
timeFrame: 12th week
measure: Boston questionnaire
timeFrame: 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT05459103: Remote Interactive Intervention for Loneliness
Official title: The Effectiveness of Remote Interactive Intervention for Loneliness, Quality of Life, and Social Support Among Seniors in Communities During the COVID-19 Pandemic: A Randomized Controlled Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 88
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Background:

During the COVID-19 pandemic, governments around the world adopted the practice of physical distancing, which increased the loneliness experienced by seniors and indirectly affected their quality of life and social support. Remote interaction through online social apps may be the safest and easiest way to address these problems. However, the empirical research on this issue is very limited.

Objective:

This study investigated the impact of a 12-week remote interaction intervention on loneliness, quality of life, and social support for seniors living in a community during the COVID-19 pandemic.

Methods:

This study adopted a randomized controlled trial design and was conducted in communities in central Taiwan. Participants in the intervention group received a 12-week bidirectional remote interaction intervention, while participants in the control group received a 12-week unidirectional remote interaction intervention. The study's primary assessment tools were the UCLA Loneliness Scale and the World Health Organization Quality of Life-BREF Scale (WHOQOL-BREF). The secondary assessment tool was the Inventory of Socially Supportive Behavior.


Eligibility criteria: Inclusion Criteria:

* Participants had to satisfy several inclusion requirements. They had to (1) be seniors aged 65 years or older; (2) be able to communicate in Mandarin and Taiwanese; (3) have an MMSE score higher than 20 20 (following Chiang et al., 2010); (4) be able to use a smartphone; and (5) have no previous psychiatric diagnosis.

Exclusion Criteria:

* The study excluded (1) those who were unable to understand how to use Line or YouTube; (2) participants in the experimental group who did not fully participate in the 12-week intervention (at least three days of interaction per week); (3) those who were unable to understand the content of the questionnaire or cooperate with those assigned to help them fill it in; and (4) those who had a major illness or surgery such as a fracture within the last three months.

Primary outcomes:
measure: UCLA Loneliness Scale (UCLA)
timeFrame: 10-20 minutes
measure: WHO Quality of Life-BREF (WHOQOL-BREF) Scale
timeFrame: 10-20 minutes
Secondary outcomes:
measure: Inventory of Socially Supportive Behavior (ISSB) Scale
timeFrame: 10-20 minutes
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia Univeraity
state: WuFeng
Study officials:
References:
Clinical trial NCT01001403: Effect of Nafamostat on Postreperfusion Syndrome (PRS)
Official title: Effect of Nafamostat Mesilate on Hemodynamic Stability After Reperfusion of the Liver Graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Transplantation
Postreperfusion Syndrome
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-10-26
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (PRS) that frequently occurs during liver transplantation.


Eligibility criteria: Inclusion Criteria:

* \>= 18 year old scheduled to undergo liver transplantation

Exclusion Criteria:

* Previous history of pulmonary, cardiovascular, or renal disease
* Previous history of allergic reactions to nafamostat

Primary outcomes:
measure: Number of Participants With Moderate and Severe Postreperfusion Syndrome (PRS)
timeFrame: during 5 min after reperfusion of liver graft
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04680403: Video Telehealth Exercise Training in Cystic Fibrosis
Official title: Video Telehealth Exercise Training in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to begin an exercise program for patients with a cystic fibrosis (CF) exacerbation.

Detailed description: The study will enroll 25 patients with CF during an introduction visit and initiate an ambulatory 1) tailored exercise regimen and 2) behavior change techniques focused on adherence and sustainability of exercise. The intervention will be delivered via a data-enabled smartphone with video capabilities facilitating live and interactive two-way video-conferencing using a HIPAA compliant app. Participants will receive supervised exercise paired with coaching on behavior change techniques over 12 weeks in 3 weekly 1-hour sessions, and will have monthly phone follow-ups and clinic follow-ups at 3 and 6 months.

Eligibility criteria: Inclusion Criteria:

Diagnosed with Cystic Fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks

Exclusion Criteria:

any comorbidity that precludes exercise

-

Primary outcomes:
measure: Feasibility and acceptability
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Stefanie Krick
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02995603: Patient Experience and Acceptance of Horizontal Rotation
Official title: Nano-X: Patient Experience and Acceptance of Horizontal Rotation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Radiotherapy
Rotation
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Prince of Wales Hospital, Sydney
First posted: 2016-12-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Patients will complete validated psychometric questionnaires to quantify their experience of being rotated at different speeds using the Nano-X patient rotation system.

Detailed description: Study participants will be asked to attend the clinic on two separate occasions. Each session will last less than one hour. Patients will be asked to complete validated psychometric surveys assessing 1) their level of claustrophobia, 2) their level of anxiety and 3) their (baseline) motion sickness, before and after each session. They will then be rotated 3-4 times on the Nano-X patient rotation system, at varying speeds ranging from 6°/sec to 45°/sec. Each rotation will be designed to simulate a typical radiotherapy treatment; that is 9 angles, pausing for around 30 seconds at each angle. Straight after each rotation, patients will again complete the questionnaire assessing their anxiety levels and motion sickness.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of cancer, any stage
2. ≥18 years of age
3. Eastern Cooperative Oncology Group (ECOG) status 0-2
4. Currently or previously being treated with radiotherapy
5. Any prior therapy allowed
6. Willing and able to comply with all study requirements
7. Must be able to read and complete questionnaires in English
8. Signed, written informed consent

Exclusion Criteria:

1. Pregnant women
2. Mentally impaired patients or patients for whom attaining informed consent would be difficult (including language barriers)
3. Severe vertigo or recent diagnosis of Benign Paroxysmal Positioning Vertigo

Primary outcomes:
measure: Change in level of patient anxiety following rotation in the Nano-X Patient Rotation System
timeFrame: 1 hour
measure: Change in level of patient motion sickness following rotation in the Nano-X Patient Rotation System
timeFrame: 1 hour
measure: Correlation between claustrophobia and the change in anxiety and motion sickness of patients following rotation in the Nano-X Patient Rotation System
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Paul Keall, Prof
role: STUDY_CHAIR
References:
Clinical trial NCT04961203: Pathways of Patients Followed in Palliative Care at the University Hospital of Strasbourg: a Retrospective Pilot Study
Official title: Pathways of Patients Followed in Palliative Care at the University Hospital of Strasbourg During the Year 2020: a Retrospective Pilot Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Palliative care
Pathways
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient met by the palliative care mobile team or admitted in palliative care unit and who died between January 2020 and December 2020.

Brief summary: In view to develop a study design for a study that would analyze the pathways of palliative care prospectively, this work will identify the individual factors that would be significantly associated with typical pathways of palliative care.


Eligibility criteria: Inclusion Criteria:

* Patient met by the palliative care mobile team or admitted in palliative care unit
* Patient who died between January 2020 and December 2020.

Exclusion Criteria:

* Minors and incapacitated adults, or deprived of liberty
* Patient who explained their disagreement with the use of medical data for research purposes.

Primary outcomes:
measure: Retrospective study describing the patient care pathway
timeFrame: The files analyzed retrospectively concern the period from January 01, 2020 to December 31, 2020.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de soins Palliatifs - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de soins Palliatifs - Hôpitaux Universitaires de Strasbourg
name: Laurent Calvel, MD, PhD
role: STUDY_DIRECTOR
References: