louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02935491: 4 Cities for Assessing CAlcification PRognostic Impact After TAVI
Official title: 4 Cities for Assessing CAlcification PRognostic Impact After TAVI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Disease
Keywords: TAVI
Aortic stenosis
aortic stiffness
calcifications
CT-scan
Vascular impedance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-10-17
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sex presenting with a severe aortic stenosis with the indication of aortic replacement by TAVI

Brief summary: Transcatheter Aortic Valve Implantation (TAVI) indications are progressing rapidly as an alternative to conventional surgery for aortic stenosis cure. Despite a high rate of procedural success, some patients do not benefit from the procedure. The investigators hypothesis is that aortic stiffness may be of major prognostic significance after stenosis relief.

The aim of this study is to test the prognostic impact of aortic stiffness estimated by the volume of calcifications of the thoracic aorta on the CT-scan performed systematically before the procedure. This prognostic value will be assessed in 4 independent cohorts issued from 4 french cities (Lyon, Rouen, Paris, Clermont-Ferrand).


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Patient who underwent a transcatheter aortic valve implantation
* Patient who provided informed, written consent to participate to FRANCE TAVI study
* Patient for whom a CT-Scan performed before TAVI procedure is available.

Exclusion Criteria:

* none

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: censored on 3 March 2017
Secondary outcomes:
measure: All-cause deaths
timeFrame: censored on 3 March 2017
measure: left ventricular remodeling
timeFrame: censored on 3 March 2017
measure: left ventricular ejection fraction
timeFrame: censored on 3 March 2017
measure: diastolic function
timeFrame: censored on 3 March 2017
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
References:
Clinical trial NCT05631691: Impact of School Based Intervention on Psychosocial Factors Associated With Trauma Among Adolescents
Official title: Impact of School Based Intervention on Psychosocial Factors Associated With Trauma Among Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Interventional Study
Lead sponsor: Fatima Jinnah Women University
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 300
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this study, participants will be screened initially and then by randomization groups will be formed for intervention and comparison group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The present study is designed to identifying the post-traumatic stress symptoms in children experiencing some traumatic event and to adapt and apply school based intervention (Support for students exposed to trauma SSET) to students who shows the symptoms of post-traumatic stress disorder.

Detailed description: Childhood trauma is a major mental health problem in recent era. Children who experienced sudden trauma have difficulty in learning, poor concentration in schools, and faced emotional and behavioral difficulties (Holt, Finkelhor, Kantor, 2007). Children who have been exposed to traumatic event are at a higher risk of developing psychopathology followed by trauma (Alisic et al.,2014). The present study is designed to identifying the post-traumatic stress symptoms in children experiencing some traumatic event and to adapt and apply school based intervention (Support for students exposed to trauma SSET) to students who shows the symptoms of post-traumatic stress disorder. This school based intervention (SSET) will provides a basis for how students can address overwhelming emotions, can deal with their daily life stressors and proactively learn to address unhelpful or maladaptive cognitions in positive way. This study will help to aware parents and teachers about mental health needs of children and adolescents.

Eligibility criteria: Inclusion Criteria of the study is:

* meets the cut off score on scale CATS (child and adolescent trauma screen).
* students availability for intervention phase
* age range 10-16 years

Exclusion Criteria:

* students above 16 years and below 10 years will not be included in the study.
* receiving any psychological/Mental health services or taking antidepressants
* Students whose primary problem is child abuse .

Primary outcomes:
measure: Reduction in symptoms of PTSD, psychological distress, behavioral problems and increases resilience and social support of students who have some traumatic exposure
timeFrame: 6 to 8 week sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Muzaffarabad
country: Pakistan
facility: Pakistan
state: Azad Kashmir
Study officials:
References:
Clinical trial NCT00759291: The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
Official title: The Impact of Free Fatty Acid Reduction on Vascular Function in the Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Metabolic Syndrome
Keywords: free fatty acids
insulin-mediated
endothelium-dependent vasodilation
metabolic syndrome
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will test the hypothesis that reducing the release of free fatty acids (FFA) from fat cells will restore insulin-mediated, endothelium-dependent vasodilation in people with the metabolic syndrome.

Detailed description: We hypothesize that acipimox, by decreasing plasma FFA concentrations, will augment endothelium-dependent vasodilation in conduit vessels and insulin-mediated vasodilation in forearm resistance arterioles in vivo, whole-body insulin sensitivity, and AKT (also known as Protein Kinase B) and endothelial nitric oxide synthase (eNOS) phosphorylation in skin biopsy specimens ex vivo, when compared with placebo.

Eligibility criteria: Inclusion Criteria:

* Adults with metabolic syndrome, defined as the presence of 3 of 5 components of the syndrome as defined by the National Cholesterol Education Program including:

  * abdominal obesity
  * elevated fasting blood sugar (110 mg/dL\< glucose \< 126 mg/dL)
  * low HDL
  * elevated fasting blood triglycerides (\> 150 mg/dL)
  * hypertension (BP \> 140/90 mm HG)
* Normal cardiovascular examination

Exclusion Criteria:

* Diabetes mellitus
* Untreated hypercholesterolemia (LDL \> 75th percentile for age)
* Cigarette smoking within 1 year
* Renal insufficiency (creatinine \> 1.4 mg/dl)
* Blood dyscrasia
* Hepatic dysfunction (ALT \> 2x normal)
* Evident coronary/peripheral atherosclerosis

Primary outcomes:
measure: Flow Mediated Vasodilation
timeFrame: After 7 days of each treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Joshua A. Beckman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aday AW, Goldfine AB, Gregory JM, Beckman JA. Impact of Acipimox Therapy on Free Fatty Acid Efflux and Endothelial Function in the Metabolic Syndrome: A Randomized Trial. Obesity (Silver Spring). 2019 Nov;27(11):1812-1819. doi: 10.1002/oby.22602. Epub 2019 Oct 1.
Clinical trial NCT00071591: Rehabilitative Training for Older People With Schizophrenia
Official title: Functional Skills Training for Late Life Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-10-30
Enrollment: 240
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This study will evaluate the effectiveness of a rehabilitation program called Functional Adaptation Skills Training (FAST) in treating older patients with schizophrenia.

Detailed description: People with schizophrenia often have problems functioning in everyday life. As people with schizophrenia get older, resources for effective health care and social services may become more limited. There is a need to develop effective rehabilitation programs that are sensitive to the special needs of older persons with schizophrenia.

Patients are randomly assigned to either 1 of 2 groups. The FAST group will involve 24 sessions of group intervention designed to enhance daily functioning of older patients with schizophrenia. The placebo group will involve participation in a psychosocial support group for an equivalent amount of time. Treatment is followed by 6 monthly maintenance sessions. Patients will be assessed at 6, 12, and 18 months after the study start. Assessments include clinical and functional measures.

Eligibility criteria: Inclusion Criteria:

* Have schizophrenia or schizoaffective disorder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT05933291: Single-cell Landscape of BALF in Patients With Severe ARDS and CARDS
Official title: Single-cell Landscape of BALF in Patients With Severe ARDS and CARDS: an Analysis of the Effectiveness of Steroid Therapy and a Comparison Between COVID-19 ARDS and ARDS From Other Etiologies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS: Acute Respiratory Distress Syndrome
Covid19
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 4 COVID-19 ARDS patients, 4 non-COVID-19 ARDS patients

Brief summary: The goal of this observational study is to learn about the effect of steroid therapy in patients with COVID-19 ARDS. The main questions it aims to answer are:

* Differences between patients with COVID-19 ARDS before and after steroid treatment in BALF single cell landscape, as well as patients with different prognosis.
* Differences between COVID-19 and non COVID-19 ARDS patients in BALF single cell landscape.

Participants will Choose whether to use or not to utilize steroid treatment based on conditions.

Detailed description: Collect BALF from COVID-19 and non-COVID-19 ARDS patients both before and during remission, then perform single-cell sequencing.

Eligibility criteria: Inclusion Criteria:

* Severe ARDS patients

Exclusion Criteria:

* None

Primary outcomes:
measure: single-cell analysis in BALF before treatment
timeFrame: before treatment in ICU
measure: single-cell analysis in BALF after treatment
timeFrame: After treatment in ICU for 1-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking union medical college hospital, ICU department
name: Yun Long, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06324591: Observational Prospective Study to Identify Intestinal Microbial Profiles in Newly Diagnosed Crohn's Disease Patients
Official title: Multicentre Observational Cohort Study in Newly Diagnosed Crohn's Disease Patients Aimed at Identifying Intestinal Microbial Profiles Correlated With Low and High Risk of Severe Disease Course
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Crohn's disease (CD), a chronic inflammatory disease affecting the intestine, is characterised by a relapsing course. In 25% of cases, the onset of this disease occurs in childhood. Relevant studies have provided evidence of a key role of gut microbial communities (the microbiota) in triggering or maintaining active gut inflammation, pointing to gut dysbiosis as the main event disrupting the balance of microbial communities Recent evidence suggests that, in addition to the bacterial component, the commensal fungal component also plays a crucial role in CD.

The purpose of this prospective, longitudinal, study is to characterise the composition of intestinal bacterial and fungal communities in patients 6-18 years newly diagnosed with Crohn Disease in order to identify a possible association of specific faecal microbial profiles with a severe or mild-to-moderate disease course.


Eligibility criteria: Inclusion Criteria:

* Children/young people aged between 6 and 18 years with newly diagnosed CM according to recognised diagnostic criteria
* Obtaining informed consent

Exclusion Criteria:

* Refusal to participate in the study.

Primary outcomes:
measure: Modifications in alpha and beta diversity of stool microbiome profile in patients with different phases of disease course (at diagnosis, remission and after one year of mantainance therapy)
timeFrame: 3 years after beginning of the study
Secondary outcomes:
measure: Differences intestinal alpha and beta diversity, microbiome richness and composition between patients at high risk and patients at low risk
timeFrame: 3 years after beginning of the study
measure: Indentification of different patterns of intestinal microbiome as a potential biomarker for high and low risk stratification
timeFrame: 3 years after beginning of the study
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz-Educational center for Paediatric Gastroenterology, Hepatology and Nutrition, Department of Paediatrics and adolescence medicine
city: Bologna
country: Italy
facility: Ospedale Maggiore-Azienda Usl Di Bologna
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Paolo Lionetti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00507091: Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination
Official title: A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic
Colorectal
Adenocarcinoma
Keywords: ZD6474
Irinotecan
5-Fluorouracil
Leucovorin
colorectal
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.


Eligibility criteria: Inclusion Criteria:

1. Confirmed metastatic colorectal adenocarcinoma
2. Not amenable to surgery or radiation therapy
3. Eligible for first or second line chemotherapy

Exclusion Criteria:

1. Brain metastases or spinal compression
2. Last prior chemotherapy discontinued within 4 weeks before start
3. Last dose radiotherapy within 4 weeks of start

Primary outcomes:
measure: Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations
timeFrame: assessed at each visit
Secondary outcomes:
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Saunders MP, Wilson R, Peeters M, Smith R, Godwood A, Oliver S, Van Cutsem E. Vandetanib with FOLFIRI in patients with advanced colorectal adenocarcinoma: results from an open-label, multicentre Phase I study. Cancer Chemother Pharmacol. 2009 Sep;64(4):665-72. doi: 10.1007/s00280-008-0914-4. Epub 2009 Jan 29.
Clinical trial NCT01771991: Study of Topical Superoxide Dismutase to Treat Radiation Induced Fibrosis
Official title: Topical Superoxide Dismutase For the Treatment of Radiation Induced Fibrosis in the Head and Neck Cancer Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Induced Fibrosis to the Head and Neck
Keywords: fibrosis
radiation
neck
cancer
Sodermix
Lead sponsor: Sanford Health
Sponsor class: OTHER
First posted: 2013-01-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if topical superoxide dismutase is an effective treatment of radiation related neck fibrosis, and to determine the quality of life impact from radiation related fibrosis in the head and neck cancer patients at Sanford Health.

Detailed description: The primary goal of this study is to evaluate the effect of topical Superoxide Dismutase (SOD) on the radiation induced fibrosis in head and neck cancer patients. A prospective, blinded, two group control design will be used with pretest and post test quality of life as well as objective fibrosis assessment. Patients will be randomized to alternatively receive topical SOD or placebo as instructed on twice daily use for 3 months. Pre and post treatment quality of life surveys and objective assessment will determine if the topical SOD improves neck fibrosis/function and global quality of life.

This study will increase clinical trial awareness and participation while potentially improving the long term functional outcomes of head and neck cancer patients.

Eligibility criteria: Inclusion Criteria:

* must have evidence of neck fibrosis
* previous radiation treatment to the neck for cancer
* age greater than or equal to 18 years
* life expectancy of greater than 12 weeks
* ability to understand the purpose of the study and the willingness to sign a written informed consent document.

Exclusion Criteria:

* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SOD or Cetaphil cram.
* any psychological, familial, sociological or geographical conditions that do not permit medical follow-up and compliance with the study protocol.

Primary outcomes:
measure: Improvement in Neck Fibrosis
timeFrame: 3 months
Secondary outcomes:
measure: Determine the Quality of Life Impact From Radiation Related Fibrosis in Head and Neck Cancer Patients
timeFrame: 3 months
measure: Determine the Pain From Radiation Related Fibrosis in Head and Neck Cancer Patients
timeFrame: From baseline to 3 months.
measure: Cervical Spine Range of Motion
timeFrame: 3 months
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
Study officials:
affiliation: Sanford Health/Sanford Clinic ENT
name: William C Spanos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06418191: Mobile Apps Enhancing Acupressure Therapy Compliance and Efficacy for Asthenopia
Official title: The Role Of Mobile Applications In Therapy Compliance And Efficacy Of Acupressure In Asthenopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthenopia
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2024-05-17
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if a mobile application works to improve adherence to acupressure therapy in asthenopia. It will also learn about the efficacy of acupressure as a therapy for asthenopia. The main questions it aims to answer are:

-Does a mobile application have a role to improve therapy compliance and efficacy of self-guided acupressure in asthenopia?

Researchers will compare users of a mobile app to non-users of a mobile app to see if a mobile app works to improve adherence to acupressure therapy in asthenopia

Participants will:

* Do acupressure 2 times every day for 4 weeks
* Filling in the absence link has been after doing acupressure every day
* Fill out the link regarding the condition of asthenopia once per week

Detailed description: This is a clinical trial study to evaluate the role of a mobile application in therapy compliance and acupressure efficacy in asthenopia sufferers. Participants are 60 males/females aged 18-64 years. They will be divided into 2 groups: (1) Acupressure mobile app users and (2) Non-acupressure mobile app users. Acupressure is scheduled 2 times every day for 4 weeks. Therapy compliance will be assessed from the absence link that participants fill out every day, while therapy efficacy will be assessed once per week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Using a smartphone with the Android platform.
* Work or use digital gadgets for at least 4 hours a day.
* Suffering from asthenopia as indicated by a CVS-Q score ≥ 6.
* Can be contacted with the WhatsApp application.
* Willing to take part in this research until completion and agree to informed consent.

Exclusion Criteria:

* There are tumors, wounds or skin infections in the eye area.

Primary outcomes:
measure: Daily Report of Acupressure
timeFrame: 2 times every day for 4 weeks
Secondary outcomes:
measure: Computer Vision Syndrome Questionnaire (CVS-Q)
timeFrame: Monitored once per week for 4 weeks
measure: Visual Analog Scale (VAS)
timeFrame: Monitored once per week for 4 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: DKI Jakarta
Study officials:
affiliation: The Ethics Committee of the Faculty of Medicine, University of Indonesia - RSCM
name: KEPK FKUI-RSCM
role: PRINCIPAL_INVESTIGATOR
References: