louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03884426: Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
Official title: Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mitral Valve Prolapse
Genetic Disease
Keywords: Mitral valve prolapse
genetic
echocardiography
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Brest
name: Rennes University Hospital
First posted: 2019-03-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both sex of any age with typical mitral valve prolapse and relatives examined during familial screening

Brief summary: Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.

Detailed description: After clinical identification of patients with MVP, doctors organize 1st degree relative familial screening. A comprehensive echocardiography was carried out along with clinical examination. All echo data were stored for off-line analysis by a sonographer in our Core-lab. Blood was sample at the time of echocardiography in adult patients for DNA analyses. Follow-up for mitral valve changes will be performed after 5 years.

Eligibility criteria: Inclusion Criteria:

* Patients of any age
* with typical mitral valve prolapse
* relatives examined during familial screening

Exclusion Criteria:

* Refusal of the patient

Primary outcomes:
measure: MVP defined by a superior displacement of at least 2 mm
timeFrame: At Day 0
Secondary outcomes:
measure: Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus)
timeFrame: At Day 0
measure: Comprehensive mitral valve apparatus characterization per other items (papillary muscle, ventricles)
timeFrame: At Day 0
measure: Comprehensive mitral valve apparatus characterization per size of items (ventricle and atrium sizes)
timeFrame: At Day 0
measure: Comprehensive mitral valve apparatus characterization per size of items
timeFrame: At Day 0
Other outcomes:
measure: Incidence of cardiac or clinical defects associated with MVP
timeFrame: At Day 0 Follow-up will be carried out at 5 and 10 years
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Nantes
country: France
facility: Nantes University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Vincent Probst, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Hervé Le Marec, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Jean-Jacques Schott, DR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06627426: Virtual Reality for Patient Informed Consent in Neurosurgery
Official title: Virtual Reality for Patient Informed Consent in Neurosurgery - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: VR-based Informed Consent
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-10-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this randomized controlled trial is to evaluate benefits of VR (virtual reality)-based patient informed consent in neurosurgery regarding subjective patient comprehension, patient-doctor relationship and anxiety.

Detailed description: Additionally, the investigators aim to assess the cost-benefit radio as well as feasibility in a clinical routine setting. Considering the increasing patient participation in decision-making, VR could lead to better understanding of complex surgical procedures, improving the perioperative process for both, patient and surgeon, and reduce anxiety.

Eligibility criteria: Inclusion Criteria:

* Patients between the age of 18 and 75
* Surgical clipping for intracranial aneurysm, resection of vascular malformations
* Craniotomy and Resection of intracranial tumors that can be segmented for VR

Exclusion Criteria:

* Visual or auditory impairment with no sufficient aid
* Patient that had VR informed consent for surgery before
* Psychiatric illness, cognitive impairment

Primary outcomes:
measure: Comparison of intensity of anxiety between intervention and control group
timeFrame: one time assessment at day 1
measure: Comparison of patient doctor relationship between intervention and control group
timeFrame: one time assessment at day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Emilia Westarp, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06791226: Evaluating the Usefulness of 18F-AlF-FAPI PET/ CT in Orbital Neoplasms
Official title: Evaluating the Potential Usefulness of 18F-AlF-FAPI PET/ CT in Patients With Orbital Neoplasms and Compared With 18F-FDG PET/ CT
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orbital Neoplasms
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2025-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the potential usefulness of 18F-AlF-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in orbital neoplasms, and compared with 18F-FDG PET/CT.

Detailed description: Subjects with orbital neoplasms underwent contemporaneous 18F-AlF-FAPI and 18F-FDG PET/CT for initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of metastatic lesions of 18F-FDG and 18F-AlF-FAPI PET/CT were recorded by visual interpretation. The sensitivity, specificity, and accuracy of 18F-AlF-FAPI, 18F-FDG PET/CT were calculated and compared to evaluate the diagnostic accuracy.

Eligibility criteria: Inclusion Criteria:

1. patients with suspected or newly diagnosed orbital neoplasms (supporting evidence may include MRI, CT and pathology report);
2. patients who had scheduled both 18F-FDG and 18F-AlF-FAPI PET/CT scans;
3. patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

1. patients with pregnancy;
2. breastfeeding;
3. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: SUV metrics
timeFrame: through study completion, an average of 6 months
measure: Tumor-to-background ratio
timeFrame: through study completion, an average of 6 months
measure: Number of lesions
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dept. of Nuclear Medicine, Peking University Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT05532826: Clinical Study of Donor EBV-CTL Infusion in Patients With CAEBV and EBV-HLH After Allo-HSCT
Official title: Clinical Study on the Efficacy and Safety of Donor EBV-CTL Infusion in Patients With CAEBV and EBV-associated Hemophagocytic Lymphohistiocytosis After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Active Epstein-Barr Virus Infection
Virus-Associated Hemophagocytic Syndrome
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 15
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Detailed description: Evaluate the efficacy and safety of donor EBV-specific T lymphocytes (EBV-CTL) infusion in patients with chronic active Epstein-Barr virus infection (CAEBV) and EBV-associated hemophagocytic lymphohistiocytosis (EBV-HLH) after allogeneic hematopoietic stem cell transplantation (allo-HSCT)

Eligibility criteria: Inclusion Criteria:

1. Patients with CAEBV or EBV-HLH who were eligible for allogeneic hematopoietic stem cell transplantation agreed to regular monitoring of EBV-DNA after transplantation.
2. Age ≤65 years old, ECOG score 0-2.
3. Organ function: Cardiac EF≥40%, creatinine clearance ≥50%, aminotransferase (ALT/AST) \< 200U/L.
4. The estimated survival time is more than 3 months. 5) Have donors who meet the requirements of allogeneic hematopoietic stem cell transplantation donors， and the donor agreed to collect lymphocytes to prepare EBV-CTL

Exclusion Criteria:

1. The patient or donor had a New York Heart Association (NYHA) score of grade II or higher (including grade II). Or a definite diagnosis of cirrhosis.
2. There are active infections other than EBV that have not yet been controlled.
3. The donor has a blood-borne infectious disease (e.g. HIV, hepatitis B, hepatitis C, syphilis, etc.). The patient was positive for HBV-DNA or HCV-RNA.
4. Active major hemorrhage of internal organs (including gastrointestinal hemorrhage, alveolar hemorrhage, intracranial hemorrhage, etc.).
5. The donor refused to collect lymphocytes to prepare EBV-CTL cells, or the number of EBV-CTL cells prepared from the donor did not meet the infusion requirements.
6. At the same time participate in other clinical studies.

Primary outcomes:
measure: EBV-DNA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Zhao Wang
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: zhao wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05642026: INTERCOSTAL NERVE BLOCK: Efficacy of CINB for Patients With Multiple Rib Fractures
Official title: The Efficacy of Continuous Intercostal Nerve Blocks in the Treatment of Patients With Multiple Rib Fractures
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rib Fractures
Keywords: intercostal
nerve block
opioid
non steroidal
inpatient
outpatient
catheter
anesthetic
epidural
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 180
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: This is a prospective, randomized, non-blinded study comparing CINB plus medical therapy versus standard medical care (non-steroidals and opioids intravenous/oral inpatient and oral outpatient) alone for patients with multiple rib fractures. The objective of this study is to analyze the effect of continuous intercostal nerve block (CINB) in the treatment of patients admitted to the adult trauma service with rib fractures. The effectiveness of CINB as adjunctive treatment will be compared to standard medical therapy involving nonsteroidal and intravenous/oral opioid medications.


Eligibility criteria: Inclusion Criteria:

* Subjects will be at least 18 years old
* Subjects will have 2 or more identified rib fractures
* Subjects will be willing to provide informed consent for procedure
* Subjects will be identified as appropriate for initiation of continuous nerve block therapy for treatment of rib fracture associated pain.

Exclusion Criteria:

* Documented allergy to study medication
* Epidural catheter use
* Prisoners
* Refusal of CINB therapy

Primary outcomes:
measure: Length of hospital stay
timeFrame: 7 days
Secondary outcomes:
measure: Patient daily pain scores
timeFrame: 7 days
measure: Modified Morphine Equivalent (MME) differences
timeFrame: 7 days
measure: hospital-free days
timeFrame: 30 days
measure: spirometry values
timeFrame: 7 days
measure: mean respiratory rates
timeFrame: 7 days
measure: Patient reported quality of life
timeFrame: 7 days
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Zachary Warriner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05066126: Mixed Presentation on Social Media
Official title: Mixed Presentation of Content on Social Media and Its Relevant Impacts on Recall of Tobacco Related Information
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use
Tobacco Dependence
Keywords: Modified Risk Tobacco Products
Information Recall
Tobacco
Tobacco Use
Social Media
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Food and Drug Administration (FDA)
First posted: 2021-10-04
Enrollment: 828
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two between-group conditions: either receiving a high mixed presentation of content in the social media feed (where the topic varies from post to post), or a low mix of presentation of content in the social media feed (where the topic does not vary).

Additionally, two further between-subject groups will be created by independently examining effects among current and former smokers.
Primary purpose: BASIC_SCIENCE

Brief summary: This study is to understand how the presentation of information on social media influences processing and recall of information, particularly in relation to modified risk tobacco products. Participants will see a social media site where either (a) the topic of discussion varies between each post or (b) posts on the same topic are grouped together. They will then be asked to recall information about the posts they saw on the site.


Eligibility criteria: Inclusion Criteria:

* Must be a current or former smoker

Exclusion Criteria:

-

Primary outcomes:
measure: Recall of precise information
timeFrame: During experiment
measure: Recall of general information
timeFrame: During experiment
measure: Recall of source category
timeFrame: During experiment
measure: Recall of precise source
timeFrame: During experiment
Secondary outcomes:
measure: Attention paid during use of the site (self-report)
timeFrame: During experiment
measure: Attention paid during use of the site (behavioral)
timeFrame: During experiment
measure: Attitude towards smoking cessation
timeFrame: During experiment
measure: Attitude towards novel tobacco products
timeFrame: During experiment
measure: Belief of heated tobacco safety
timeFrame: During experiment
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Annenberg School for Communication
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04949126: Self Medication in Odontology (AUDE)
Official title: Self Medication and Pulpal and Periapical Dental Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Anxiety
Dental Pain
Keywords: Anxiety
Pulpal pain
Self medication
Observational study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 940
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: Adult patient with acute pain of pulp origin and periapical or eligible for dental treatment under general anesthesia in a context phobic.

Brief summary: To describe and understand the self-medication behaviours of a population of adults coming to the Clermont-Ferrand dentistry department for acute pain of pulpal origin and of a population of adults coming to the specific care unit of the Clermont-Ferrand dentistry department or the Riom hospital for treatment under general anaesthesia.

Detailed description: Self-medication behaviour will be studied by means of a questionnaire. Questionnaires on insecurity, anxiety about dental care, items related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF), a visual analogue pain assessment scale and the PCS-CF pain dramatisation scale will also be used.

Eligibility criteria: Inclusion Criteria:

* Adult patient, male or female, coming to consult in the Clermont-Ferrand or Riom Hospital for acute pain of pulp origin and periapical OR eligible for dental treatment under general anesthesia in a context phobic.
* Understanding and practicing French
* giving informed consent to participate in research.
* Affiliation to a Social Security scheme.

Exclusion Criteria:

* Patients under guardianship.
* Patient's refusal to participate in the study.

Primary outcomes:
measure: description of the self-medication behaviours
timeFrame: day 0
Secondary outcomes:
measure: level of anxiety
timeFrame: day 0
measure: level of insecurity
timeFrame: day 0
measure: description of the oral health with the related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF)
timeFrame: day 0
measure: visual analogue pain assessment scale and the PCS-CF pain dramatisation scale
timeFrame: Day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Pierre-Yves Cousson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00162526: Tocopherol is a Novel Treatment for Cancer Related Mucositis
Official title: A Randomized Double Blind Placebo Controlled Clinical Trial Aim to Assess the Efficacy of Vitamin E Formulation (Tocopherol) in the Treatment of Chemotherapy Induced Stomatitis in Patients Undergoing Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Oral Mucositis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 30
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: The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.


Eligibility criteria: Inclusion Criteria:

* Males and non-pregnant and non-lactating females, 18 years of age or older at the time of screening, who are to receive myeloablative agonists with or without total body irradiation (TBI) in preparation for either allogeneic or autologous HSCT. Patients who are to be hospitalized and are expected to remain hospitalized until marrow recovery.
* Karnofsky performance status of 60 or greater or ECOG performance status of 2 or less.
* Normal dental examination as assessed by the investigator.

Exclusion Criteria:

* Clinically significant acute and active oral cavity infection.
* Patients taking any investigational or other non-approved oral therapy for oral mucositis.
* Known hypersensitivity to Vitamin E.

Primary outcomes:
measure: To evaluate the tolerability and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist.
Secondary outcomes:
measure: To evaluate the toxicity and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Shimon Slavin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06431126: Nature and Animal-assisted Activities
Official title: Nature and Animal-assisted Activities for Young Adults With Autism and Social Withdrawal
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neuropsychiatric Syndrome
Autism Spectrum Disorder
Keywords: complementary therapies
feasability
young adults
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
First posted: 2024-05-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neuropsychiatric impairments in young adults are common and can involve social withdrawal, and difficulties in receiving support from healthcare and municipal social care services. Collaboration is needed, but knowledge gaps exist concerning effective interventions. Participation in meaningful activities, as a complement to other treatment strategies can be a step towards studies/work. The aim of the trial is to explore the feasibility of a structured nature and animal-based activity on a farm for young adults with neuropsychiatric impairments.

The intervention involves participation in nature and animal-assisted group activities, twice a week for 12 weeks. Data consists of interviews with participants prior to and after the intervention, as well as one year later. The one-year follow-up focus is on life situation, changes in everyday life and experiences of the intervention. In addition, interview-based experiences of the ordinary staff and supervisors on the farm are included. Analysis will be carried out with qualitative content analysis, as well as health-economic calculations.


Eligibility criteria: Inclusion Criteria:

* 18-30 years
* Autism Spectrum Disorder
* No occupation/employment/education over the last year
* Social insurance benefits
* Interest in being with animals

Exclusion Criteria:

* Ongoing active drug abuse
* Severe psychiatric comorbidity

Primary outcomes:
measure: Attendance
timeFrame: 12 weeks
Secondary outcomes:
measure: Experiences of participation
timeFrame: 12 weeks
measure: Occupational level
timeFrame: 1 year
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Kronoberg County Council
Study officials:
affiliation: Kronoberg County Council
name: Birgitta Gunnarsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: