louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06733740: Ultrasound-guided Thermal Ablation for Papillary Thyroid Carcinoma
Official title: The Clinical Outcomes of Ultrasound-guided Thermal Ablation for the Treatment of Papillary Thyroid Carcinoma: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillary Thyroid Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with papillary thyroid carcinoma who refuse surgery or active surveillance and choose thermal ablation

Brief summary: To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma

Detailed description: To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study

Eligibility criteria: Inclusion Criteria:

1. patients age between 18 and 80 year old, both sex
2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
3. the largest diameter ≤2.0 cm
4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
5. follow-up period ≥12 months

Exclusion Criteria:

1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
2. history of neck radiation
3. coagulation disorder, serious heart, respiratory, liver, or renal failure
4. dysfunction of the vocal cord on the opposite side

Primary outcomes:
measure: rate of disease progression
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Rate of complications
timeFrame: 1 week
measure: Rate of tumor disappearance
timeFrame: through study completion, an average of 6 months
measure: Rate of volume reduction
timeFrame: through study completion, an average of 6 months
measure: rate of change of thyroid function
timeFrame: through study completion, an average of 6 months
measure: rate of delayed surgery
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Yukun Luo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02120040: Psychosocial Consequences of the Screening of Von Hippel Lindau Diseases for Patients Operated for a hémangioblastoma of Nervous Centrasl System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemangioblastoma (HB) of the Central Nervous System (CNS)
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2014-04-22
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Von Hippel-Lindau (VHL) disease is a severe autosomal dominant genetic disorder (with almost complete penetrance) that predisposes to many tumors including some associated with a poorer outcome. Clear cell renal cell carcinoma (CCRCC) is the leading cause of mortality.

The diagnosis of VHL disease may be challenging because tumors have an asynchronous and multi-organ development and there is often no apparent hereditary context. As it is admitted that VHL disease is underdiagnosed, some countries have decided to recall patients presenting one of the potentially VHL disease-associated tumors to screen them for VHL mutation. Screening is currently recommended in guidelines but many patients may have not been previously screened.

Hemangioblastoma (HB) of the Central nervous system (CNS) is one of the typical VHL tumors and up to 20% of patients with HB show VHL mutation. VHL diagnosis in this population enables the diagnosis of other tumor types at an early stage of development since HB is chronologically the second tumor occurring during the VHL disease history.

But it raises critical problems and questions: difficult announcement of a potentially severe disease and psychosocial dimension related to inheritance of the disease.


Eligibility criteria: Inclusion Criteria:

* age \>=18;
* Surgery for a CNS HB in the department of Neurosurgery of la Timone university hospital since 1999 ;
* Absence of prior screening for VHL

Exclusion Criteria:

* minor,
* incorrect French language

Primary outcomes:
measure: evaluate the impact on anxiety of VHL mutation screening of patients operated for HB
timeFrame: two years
Secondary outcomes:
measure: assessment of the mood
timeFrame: two years
Other outcomes:
measure: assesment of quality of life
timeFrame: two years
measure: assesment of the psychological consequences of the screening
timeFrame: two years
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: Philippe Metellus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05956340: A Study of Spoken Language in Mania
Official title: Computational Analysis of Spoken Language in Mania
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Manic Episode
Bipolar I Disorder
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research is being done to find if there are changes with voice and speech during episodes of mania.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent before any study procedures are performed
* English speaker
* Documented clinical diagnosis for Bipolar I Disorder
* Undergoing hospitalization, or boarding in the Emergency Department, for mania as determined by primary clinical staff

Exclusion Criteria:

* Positive urine drug screen for amphetamines or cocaine.
* Expressing paranoid delusions regarding electronic surveillance.
* Documented clinical diagnosis of developmental delay.
* Currently involuntarily hospitalized.
* Deemed at risk for aggression.
* Failure to comprehend study objectives via comprehension questionnaire.
* Individuals who have a guardian and are unable to consent for themselves.
* Current communicable disease requiring isolation.

Primary outcomes:
measure: Acoustic Differences
timeFrame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
measure: Syntactical Differences
timeFrame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
measure: Semantic Differences
timeFrame: Approximately 48 hours after taking antimanic medications until up to end of subject participation approximately 1 month from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Minnesota
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Frye, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01256840: Long-term Caloric Restriction and Cellular Aging Markers
Official title: Caloric Restriction With Optimal Nutrition and Aging Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2010-12-09
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample and Calorie Restriction Society

Brief summary: The purpose of this study is to see whether people who have restricted the number of calories they eat for a long period of time, compared to normal-eating and obese people, have markers of cellular aging that look younger.


Eligibility criteria: Inclusion Criteria:

* Calorie restricting group: Self-reported caloric restriction for at least two years
* Calorie restriction group: BMI below 23
* Normal eating control: Normal eating (no history of caloric restriction) for two years
* Normal eating control: BMI below 30
* Obese comparison group: BMI above 30
* Obese comparison group: Normal eating (no history of caloric restriction) for two years

Exclusion Criteria:

* Regular smoker for the past six months

Primary outcomes:
measure: Telomere Length
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: A. Janet Tomiyama, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Incollingo Belsky AC, Epel ES, Tomiyama AJ. Clues to maintaining calorie restriction? Psychosocial profiles of successful long-term restrictors. Appetite. 2014 Aug;79:106-12. doi: 10.1016/j.appet.2014.04.006. Epub 2014 Apr 18.
citation: Tomiyama AJ, Milush JM, Lin J, Flynn JM, Kapahi P, Verdin E, Sinclair E, Melov S, Epel ES. Long-term calorie restriction in humans is not associated with indices of delayed immunologic aging: A descriptive study. Nutr Healthy Aging. 2017 Mar 31;4(2):147-156. doi: 10.3233/NHA-160017.
Clinical trial NCT04694040: Condylar Inclination Recorded With Modjaw® Device.
Official title: Analysis of Mandibular Kinematics of a Group of Asymptomatic Subjects Recorded With the Modjaw® Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Temporomandibular Disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: In oral rehabilitation, the integration into the digital flow of mandibular movements and the patient's individual reference planes optimizes the functional adaptation of prosthetic elements whose design is computer aided. The innovative Modjaw® device allows you to record and then virtually simulate mandibular movements.

This retrospective study aims to: 1) Test the reliability of the Modjaw® device; 2) Measure the condylar displacements of asymptomatic subjects for the arbitrary programming of simulators.

Kinematic recordings of 22 healthy volunteers (15F / 7H; mean age: 22.2 years) were analyzed. Two recording sessions were carried out within one month of each other, by three different operators; each subject was followed by the same operator during the first (E1) and the second (E2) recording. The values of sagittal condylar inclination (SCI) obtained in opening, protrusion, right-left mediotrusion were calculated at 3 and 5 mm of condylar displacement. The transverse condylar inclination (TCI) was calculated at 4mm.


Eligibility criteria: Inclusion criteria : adult ;

Exclusion criteria : temporomandibular disorders (TMD symptom questionnaire)

Primary outcomes:
measure: Reliability of recordings
timeFrame: 5 months
Secondary outcomes:
measure: Mandibular motion
timeFrame: 5 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE - Hôpital St Roch
Study officials:
References:
Clinical trial NCT06549140: Effects of an Augmented Reality Exercise Program in Older Adults
Official title: Effects of an Augmented Reality Exercise Program in Older Adults Physical Fitness and Cognitive Abilities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Augmented Reality Exercise Program
Traditional Exercise Program
Control Group
Lead sponsor: Universidade da Madeira
Sponsor class: OTHER
Collaborators: name: Élvio Rúbio Gouveia
name: Hildegardo Noronha
name: Francisco Santos
name: Mara Dionísio
name: Eva Freitas
name: Pedro Campos
name: Paulo Bala
First posted: 2024-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research aims to examine the effects of an augmented reality (AR) exercise program on physical fitness (cardiorespiratory capacity, strength, balance, agility, and flexibility) and cognitive function (reaction time, decision-making, and memory).


Eligibility criteria: Inclusion Criteria:

* Participants of both genders
* 60 years or older
* Autonomous community-dwelling older adults

Exclusion Criteria:

* Neurological disorders
* Cognitive impairment
* Health limitations related to exercise participation

Primary outcomes:
measure: Physical fitness
timeFrame: Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
measure: Physical activity
timeFrame: Participants enrolled in exercise programs will be monitored using accelerometry. Individual data will be collected in all exercise sessions (total of 48 sessions).
measure: Body composition
timeFrame: Testing sessions will occur at baseline, at week 6, at week 13 and at week 18.
measure: Cognitive function
timeFrame: The assessment will be conducted at baseline, at week 6, at week 13 and at week 18.
Secondary outcomes:
measure: SF-36 questionnaire
timeFrame: The assessment will be conducted at baseline and at week 13 after the intervention end.
Other outcomes:
Locations:
Study officials:
affiliation: University of Madeira
name: Élvio Gouveia, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00388440: Assess GSK Biologicals' MMR Vaccine (Priorix) When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
Official title: Phase IV Open Study to Assess the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Live Attenuated Measles-Mumps-Rubella (MMR) Vaccine When Given to Healthy Children at the Age of 12 to 18 Months in Singapore.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rubella
Mumps
Measles
Keywords: Mumps
Singapore
Rubella
Measles
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-10-16
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and immunogenicity of GSK Biologicals' live attenuated MMR vaccine (Priorix) in a local population in Singapore. The vaccine was administered as a single dose to healthy children (12-18 months of age) and blood samples were collected at two time points (before vaccination and after vaccination).


Eligibility criteria: Inclusion Criteria:

* A male or female infant between 12 and 18 months of age at the time of the vaccination
* Written informed consent obtained from the parents or guardians of the subject.
* Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

* Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the dose of study vaccine
* Previous vaccination against mumps and/or rubella
* History of, or intercurrent, measles, mumps, and/or rubella disease
* Known exposure to measles, mumps or rubella within 30 days prior to the start of the study
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Primary outcomes:
measure: Solicited symptoms (Day 0-3); unsolicited AEs (Day 0-42); SAEs (full study)
Secondary outcomes:
measure: Antibody concentration to all vaccine antigens after vaccination
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05060640: ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.
Official title: PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AIN3
AIN2
HSIL, High Grade Squamous Intraepithelial Lesions
Lead sponsor: University Fernando Pessoa
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-positive patients, women with genital neoplasia (cervix, vulva and vagina), solid organ transplanted recipients, patients with inflammatory bowel disease and patients with Lupus.

Brief summary: HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.

Detailed description: Procedures in all patients:

1. Digital anorectal evaluation
2. Colonoscopy with retroflection and visualization of the anal squamocolumnar junction
3. After identification of this area 5% acetic acid will be applied.
4. Visualization under NBI/BLI.
5. Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).

Eligibility criteria: Inclusion Criteria:

1. HIV-positive patients
2. Solid transplanted recipients
3. Crohn's disease patients under immunosuppression: steroids, thiopurines, biologics
4. Patients with lupus under immunosuppression
5. Women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva.

Exclusion Criteria:

1. Previous anal/perianal cancer history
2. Previous known history of anal/perianal intraepithelial neoplasia
3. Pelvic radiation

Primary outcomes:
measure: Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.
timeFrame: through study completion, an average of 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gondomar
country: Portugal
facility: Fernando Pessoa Teaching Hospital
state: Porto
Study officials:
References:
Clinical trial NCT00561340: Study of the Effect of Calorie Supplementation on Growth in Young Children on ADHD Medication
Official title: Caloric Supplementation During Long-Term Pharmacological Treatment of ADHD in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Growth
Atomoxetine
Pediasure
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 29
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if supplementing calories with Pediasure is effective in maintaining height, weight, and BMI percentiles for young children during 2 years of treatment with ADHD medication.

Detailed description: This is a pilot study evaluating the effect of caloric supplementation on maintenance of growth parameters during two years of open-label atomoxetine treatment in 5 and 6 year old children with ADHD. The study will assess the efficacy of caloric supplementation in maintaining baseline percentiles for height, weight, and body mass index (BMI). Patients will be randomly assigned to receive either PediaSure for caloric supplementation, or no supplementation.

Secondary aims include assessing the tolerability and efficacy of long-term, open-label atomoxetine treatment in 5 and 6 year old children with ADHD, and obtaining adequate pilot data regarding the safety, efficacy, and potential effects of atomoxetine on growth parameters in order to submit a multisite R01 to more adequately assess atomoxetine treatment and its effects in young children with ADHD.

Eligibility criteria: Inclusion Criteria:

* Children who participated in the 8 week DBPC trial of atomoxetine (1K23MH066127) who wish to participate in a long-term, open label trial of atomoxetine.
* Parents and patients must be able to attend regular study visits. Visits will be scheduled every 30 days for the first 6 months and then every 60 days for the next 18 months.
* Children who are on alternate medications due to inefficacy or intolerability of atomoxetine may still participate.

Exclusion Criteria:

* Parents who are unwilling to provide informed consent.

Primary outcomes:
measure: Weight Change
timeFrame: 6 months
measure: Height Change
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Department of Psychiatry
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Christopher J Kratochvil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spencer TJ, Newcorn JH, Kratochvil CJ, Ruff D, Michelson D, Biederman J. Effects of atomoxetine on growth after 2-year treatment among pediatric patients with attention-deficit/hyperactivity disorder. Pediatrics. 2005 Jul;116(1):e74-80. doi: 10.1542/peds.2004-0624.
Clinical trial NCT00787540: Chest Pain, Illness Perception Compliance and Psychosocial Outcome After Coronary Arteriography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Disease
Keywords: Coronary disease
Psychosocial
Nursing
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-11-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present to the coronary unit at the Hillel Yaffe Medical Center, Hadera, Israel

Brief summary: Chest pain, illness perception compliance and psychosocial outcome after coronary arteriography. A comparison between patients which were diagnosed with slow coronary flow and patients who have been diagnosed with coronary artery occlusion. We hope to prove that the more knowledge and awareness the patient has about his disease the better his compliance and rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Adult patients with slow flow or coronary artery occlusion

Exclusion Criteria:

* All other patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Coronary Care Unit, Heart Institute, Hillel Yaffe Medical Center
Study officials:
References: