louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06360562: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)
Official title: Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)- Resilience Training in Virtual Reality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mood Disorders
Anxiety Disorders
Psychotic Disorders
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 174
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality.


Eligibility criteria: Inclusion criteria for college student participants:

1. 18-30 years old
2. Enrolled in an undergraduate program

Inclusion criteria for healthcare provider participants:

1. At least 18 years old
2. Employed in the healthcare field with some direct patient contact

Exclusion Criteria:

1. Inability to provide informed consent
2. Not proficient in English
3. Acute symptoms of a psychiatric illness needing immediate care (such as acute psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by self-report that necessitates close monitoring or inpatient or partial hospitalization.
4. Enrolled in current psychotherapy with frequency of more than once per month

Primary outcomes:
measure: Discomfort with Others
timeFrame: Before the intervention, 6 weeks later, and 6 months later
measure: Intervention Feasibility and Acceptability
timeFrame: Before the intervention, 6 weeks later, and 6 months later
measure: Penn Emotion Recognition Test
timeFrame: Before the intervention, 6 weeks later, and 6 months later
measure: Stop Distance Paradigm
timeFrame: Before the intervention, 6 weeks later, and 6 months later
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Before the intervention, 6 weeks later, and 6 months later
measure: Spielberger State-Trait Anxiety Inventory
timeFrame: Before the intervention, 6 weeks later, and 6 months later
measure: Prodromal Questionnaire- Brief
timeFrame: Before the intervention, 6 weeks later, and 6 months later
measure: Connor-Davidson Resilience Scale
timeFrame: Before the intervention, 6 weeks later, and 6 months later
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT06291662: Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
Official title: Evaluation of Performance Characteristics and Applicability in Oncology of Devices Customized Medical Devices Made by 3D Printing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma
Intracranial Neoplasm
Pelvic Bone Neoplasm
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 12
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Oncologic patients
Primary purpose: OTHER

Brief summary: Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies.


Eligibility criteria: Inclusion Criteria:

* Primary tumor of the pelvic bone Primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity in the upper and/or lower jaw. over 10 years of age
* Primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor aged 7-18 years
* Intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary aged 18-70years
* signed informed consent form

Exclusion Criteria:

* inoperability;
* presence of pathological fractures.

Primary outcomes:
measure: 3D model feasibility for pre-surgical making decisions
timeFrame: through study completion, an average of 1 year
measure: Surgical time
timeFrame: through study completion, an average of 1 year
measure: Device feasibility
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi (AOUC)
city: Firenze
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Siena
country: Italy
facility: Azienda Ospedaliero Universitaria Senese (AOUS)
Study officials:
References:
Clinical trial NCT03384862: Nutrition, Arsenic and Cognitive Function in Children
Official title: Nutrition, Arsenic and Cognitive Function in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arsenic Exposure
Keywords: Arsenic exposure
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Environmental Health Sciences (NIEHS)
First posted: 2017-12-28
Enrollment: 239
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main goals of this study are to evaluate whether supplementation with folate and vitamin B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as previously observed in adults). The investigators will also explore whether folate and B12 can mitigate arsenic-related decrements in cognitive abilities.

Detailed description: While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top priority, this has proven difficult. After decades of efforts to reduce exposure, 42 million people in Bangladesh remain exposed to As above 10 µg/L, the WHO guideline for As in drinking water. Risk for arsenic-related health outcomes lingers for decades after exposure has been reduced. Innovative strategies to lower arsenic exposure and and reduce its potential adverse health effects of As are needed.

Eligibility criteria: Inclusion Criteria:

* Age-eligible children of parents enrolled in the Health Effects of Arsenic Longitudinal Study cohort

Exclusion Criteria:

* siblings
* twins
* children who are not attending school
* children with known physical disability or known chronic illness

Primary outcomes:
measure: Change in arsenic methylation
timeFrame: Up to 12 Weeks
measure: Change in in blood arsenic
timeFrame: Up to 12 Weeks
measure: Change in blood monomethyl arsenic
timeFrame: Up to 12 Weeks
Secondary outcomes:
Other outcomes:
measure: Change in WASI-II cognitive function test score
timeFrame: Up to 12 Weeks
Locations:
city: Dhaka
country: Bangladesh
facility: Columbia University Bangladesh
Study officials:
affiliation: Columbia University
name: Mary V Gamble, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bae S, Kamynina E, Guetterman HM, Farinola AF, Caudill MA, Berry RJ, Cassano PA, Stover PJ. Provision of folic acid for reducing arsenic toxicity in arsenic-exposed children and adults. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD012649. doi: 10.1002/14651858.CD012649.pub2.
Clinical trial NCT05330962: 10 Years Cardiovascular Risk Score Among Primary Health Care Centre Attendees, Assiut Governorate.
Official title: 10 Years Cardiovascular Risk Score Among Primary Health Care Centre Attendees, Assiut Governorate.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Risk Score
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 383
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Attendees of primary health care centre, Assiut governorate.

Brief summary: The study aim to assess cardiovascular risk score among patients of AlHadary primary health care centre in Waldeya, Assiut governorate. And to determine the awareness about cardiovascular risk among these patients as well.

Detailed description: An analytical, cross-sectional study will be conducted in a primary health care center in Assiut governorate. Aiming to assess cardiovascular risk among attendees of the center and determine the awareness about cardiovascular risk among them.

Eligibility criteria: Inclusion Criteria:

* Male 30-65 years old, or female 40-70 years old.

Exclusion Criteria:

* History of ischemic heart disease, stroke, transitory ischemic attack (TIA) or peripheral artery disease (PAD) in electronic health record.
* History of diabetes

Primary outcomes:
measure: The Framingham study cardiovascular disease 10 years risk assessment results
timeFrame: 1 year
Secondary outcomes:
measure: Total cardiovascular disease knowledge score results
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Yacoub M, Mayosi B, ElGuindy A, Carpentier A, Yusuf S. Eliminating acute rheumatic fever and rheumatic heart disease. Lancet. 2017 Jul 15;390(10091):212-213. doi: 10.1016/S0140-6736(17)31608-2. No abstract available.
Clinical trial NCT05388162: A Non-inferiority Evaluation of a Smart-phone Based Cervical Imaging Device.
Official title: Smart-phone Based Cervical Imaging Device Compared With a Standard Culposcope for the Detection of Cervical Dysplasia A Non-inferiority Evaluation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical cancer screening,colposcopy,smartphone
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: When a woman has an abnormal pap smear or tests positive for a high risk strain of the HPV virus, the current standard of care includes culposcopic examination of the cervix with biopsy. A culposcope is essentially a microscope for examining the cervix. Culposcopes cost $5-10,000 each. The device being tested in this trial is an adaptor for a smart phone that will cost \~ $125. The larger goal of this line of studies see if the images obtained using the smart phone adaptor are non-inferior to those obtained with standard culposcopes. If the device is found to provide images equal to those of standard culposscopes, it could save thousands of dollars in healthcare expenditure currently that go to the purchase and maintenance of culposcopes. This has potential world-wide applications, especially for resource poor countries. This initial trial is a non-inferiority trial to compare the images obtained with the smart phone based device of those obtained by a standard culposcope

Detailed description: See above.

Eligibility criteria: Inclusion Criteria: adult women with abnormal pap smear or HPV virus testing referred for culposcopy -

Exclusion Criteria: none

-

Primary outcomes:
measure: Determine of the smart-phone based cervical imaging device provides non-inferior image to that obtained using a standard culposcope for the detecton of cervical dysplasia
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Clinic
state: California
Study officials:
affiliation: Scripps Clinic
name: Bruce Kahn
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921362: Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme
Official title: Seroquel (Quetiapine Fumarate) InPractice Evaluation Programme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 1387
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for entry into the study will have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature

Brief summary: Patients eligible for entry into the study have a diagnosis of schizophrenia defined by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria and of a chronic or sub-chronic nature.The primary purpose of the study is to observe symptoms changes over 6 months in schizophrenia in patients treated with Seroquel; additionally disease severity and treatment compliance are followed


Eligibility criteria: Inclusion Criteria:

* To assess at baseline and after treatment administration the severity of the illness in patients with schizophrenia, using the scores obtained after the application of the CGI scale
* To assess the changes in symptoms of patients treated with Seroquel for 24 weeks, using BPRS (Brief Psychiatry Rating Scale) as measuring tool

Exclusion Criteria:

* All the patients who have a known hypersensitivity to Seroquel /quetiapine or any of its excipients will not be included in this study.

Primary outcomes:
measure: Brief Psychiatric Rating Scale - BPRS
timeFrame: Monthly at every clinic visit- 7 times
Secondary outcomes:
measure: Clinical Global Impression Severity of Illness
timeFrame: Monthly/ at every clinic visit-7 times
measure: CGI-S Clinical Global Impression Improvement CGI -I
timeFrame: Monthly/ at every clinic visit except first visit- 6 times
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca Romania
name: stina Pentiuc, Med Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06162962: Oncological and Functional Outcomes in Lower Limb Osteosarcoma Pediatric Patient
Official title: Department of Orthopedic Oncology, The First Affiliated Hospital of Sun Yat-sen University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteosarcoma
Pediatric
Lower Limb Injury
Outcome
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 345
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A retrospective analysis of 345 pediatric patients with lower-limb osteosarcoma admitted to our department between 2000 and 2019 was conducted.

Brief summary: Retrospective analysis of specific characteristics of complications and long-term oncological and function outcomes in lower-limb osteosarcoma pediatric patients.

Detailed description: Clinical and functional outcomes were compared based on age groups, surgical methods, type of prosthesis, and primary tumor location. Patients were divided into the Low-age group (≤10 years old) and the High-age group (\>10 years old). Overall Survival rate (OS), Progression-Free Survival rate (PFS), and prosthesis survival rate were assessed using Kaplan-Meier curves, and non-parametric survival analysis (log-rank test) was used for comparison. The incidence of complications, local relapse rate (LRR), metastasis rate, final limb-salvage and amputation rate, and Musculoskeletal Tumor Society (MSTS) score of different independent groups were further evaluated using χ2 test or Fisher's exact test, and t-test was employed to evaluate the measurement data.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed lower limb osteosarcoma patients under the age of 14;
2. Performing tumor resection treatment in our hospital;
3. There is complete clinical registration data available.

Exclusion Criteria:

1. Not undergoing surgical treatment in our hospital;
2. Age older than 14 years old;
3. No available clinical registration data or lost follow-up patients;
4. Non lower limb osteosarcoma patients.

Primary outcomes:
measure: Overall Survival rate (OS)
timeFrame: 2000-2019
measure: Progression-Free Survival rate (PFS)
timeFrame: 2000-2019
measure: Local recurrence rate(LRR)
timeFrame: 2000-2019
measure: Metastasis rate
timeFrame: 2000-2019
measure: Final limb-salvage and amputation rate
timeFrame: 2000-2019
measure: Prosthesis survival rate
timeFrame: 2000-2019
measure: Musculoskeletal Tumor Society (MSTS) score
timeFrame: 2000-2019
measure: Complications
timeFrame: 2000-2019
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Changye Zou
state: Guangdong
Study officials:
References:
Clinical trial NCT04110262: Human Sodium Balance Study
Official title: Sodium Regulation in Individuals on Known Dietary Sodium Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Blood pressure
Sodium
Salt
Randomized controlled trial
balance
humans
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Dietary intervention consisting of two 25-day feeding periods separated by a 10-day washout.
Primary purpose: BASIC_SCIENCE

Brief summary: The overall objective of this study is to examine how dietary sodium is used by the body. In a racially diverse sample of adults, the investigators will examine the effects of high and low dietary sodium intake on the storage and excretion of sodium and determine whether sodium distribution affects blood pressure. This has implications for how investigators interpret studies that use urine biomarkers of sodium. Study findings about tissue sodium storage also have implications for managing hypertension and related conditions.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old;
* Diagnosed with high blood pressure or pre-hypertension (systolic blood pressure (SBP) \> 120 mm Hg or diastolic blood pressure (DBP) \> 80 mm Hg);
* Taking no more than two medications for high blood pressure;
* Currently has a primary care provider;
* Willing to eat all meals provided by the study for two 14-day feeding periods;
* Willing to complete study measurement procedures.

Exclusion Criteria:

* Diabetes;
* Smoker;
* Serious food allergies;
* Currently pregnant or planning to become pregnant

Primary outcomes:
measure: Estimated sodium concentration in skin and muscle
timeFrame: 60 days
measure: Estimated sodium concentration in bone
timeFrame: 60 days
measure: Concentration of sodium, potassium, and hormone regulators in excreted urine
timeFrame: 60 days
measure: Blood pressure
timeFrame: 60 days
Secondary outcomes:
measure: Racial differences in concentrations of sodium in skin, muscle and bone
timeFrame: 60 days
measure: Racial differences in concentration of urinary potassium excretion
timeFrame: 60 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Cheryl A Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654562: The Short-term Effects of Simvastatin on the Vision of Males Affected by Choroideremia
Official title: A Repeated Measures Study of Simvastatin on Choroideremia: Simvastatin Intervention and Reversal in Choroideremia Patients and Age-matched Controls.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Choroideremia
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary objective: To examine the short-term effects of of simvastatin on the vision on males with choroideremia, evaluated by full-field scotopic threshold testing. The investigators hypothesize that they will see a reversible decrease in the dark-adapted vision in participants taking simvastatin.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male
* Diagnosed with choroideremia and in good health
* Willing to allow his general practitioner and consultant, if appropriate, to be notified of participation in the study
* Over age of 18 years

Exclusion Criteria:

* Female
* Significant health disease, disorder, or medication, which, in the opinion of the investigator, would put the patient at risk if he were to take simvastatin
* Already taking simvastatin or another statin

Primary outcomes:
measure: Full-field scotopic threshold
timeFrame: 5 weeks (4-6 weeks)
Secondary outcomes:
measure: Microperimetry, OCT, fundus autofluorescence, ERG, VA
timeFrame: 5 weeks (4-6 weeks)
measure: Microperimetry, OCT, fundus autofluorescence, ERG, VA
timeFrame: 5 weeks (4-6 weeks)
measure: Full-field scotopic threshold
timeFrame: 5 weeks (4-6 weeks)
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Ophthalmology Research Office, University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Ian M MacDonald, MD, CM
role: PRINCIPAL_INVESTIGATOR
References: