louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01616589: Validation of Saliva in the Esoterix Genetic Laboratories Fragile X Assay
Official title: Acquisition of Saliva Samples for Validation as a Specimen Type in the Esoterix Genetic Laboratories Fragile X Assay
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fragile X Syndrome
Keywords: Fragile X syndrome
Fragile X full mutation
Fragile X premutation
Fragile X intermediate
CGG repeat length
Lead sponsor: Esoterix Genetic Laboratories, LLC
Sponsor class: INDUSTRY
First posted: 2012-06-12
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: Fragile X full mutations (affecteds), fragile X premutations (carriers), and fragile X intermediates who previously had fragile X testing through Esoterix Genetic Laboratories. Subject population will be in the US.

Brief summary: The purpose of this research is to determine if saliva samples can be used as an alternate sample type to test for fragile X. By using saliva instead of blood, it would be easier for patients to have fragile X testing.

Detailed description: Saliva samples will be prospectively collected from subjects who have previously been tested by Esoterix Genetic Laboratories, LLC using blood specimens and diagnosed as fragile X intermediates, premutations (carriers) or full mutations (affected). Results from fragile X testing with saliva will be compared to results from the blood sample that was previously submitted to Esoterix Genetic Laboratories for testing.

Data from this study will be used for regulatory submissions.

Eligibility criteria: Inclusion Criteria:

* Subject has previously been identified through molecular testing at Esoterix Genetic Laboratories as a Fragile X intermediate, premutation (carrier) or full mutation (affected).
* In the opinion of the subject's physician, the subject is medically stable and able to provide the required quantity of saliva.
* If Subject is at least 18 years of age:
* Subject must be willing to give written informed consent
* Subject must be willing to comply with the collection procedure
* If Subject is under 18 years of age, the legally authorized representative must give written informed consent and agree to comply with study procedures.

Exclusion Criteria:

* Subject has been determined to be an individual with a normal FMR1 gene.
* Subject has a known medical condition that would cause risk to the donor or, if relevant, the fetus as a result of saliva collection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Westborough
country: United States
facility: Integrated Genetics
state: Massachusetts
Study officials:
affiliation: Esoterix Genetic Laboratories, LLC
name: Thomas Scholl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01516489: Improving Fecal Occult Blood Test Completion Rates Among Veterans
Official title: Improving Fecal Occult Blood Test Completion Rates Among Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Keywords: screening
colon cancer
incentives
behavioral economics
Lead sponsor: Corporal Michael J. Crescenz VA Medical Center
Sponsor class: FED
Collaborators: name: VA Pittsburgh Healthcare System
First posted: 2012-01-25
Enrollment: 1549
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 4-arm cluster randomized controlled trial to evaluate whether patient financial incentives directly integrated into primary care can improve fecal occult blood test (FOBT) completion rates. We will recruit primary care patients at the Philadelphia Veterans Affairs Medical Center (PVAMC) in 2 stages. In stage 1, we hypothesize that, compared to usual care, $5, $10, $20 incentives will each lead to a statistically significant increase in the rate of FOBT completion. We also hypothesize that there will be a direct dose-response relationship between the incentive amount and rates of FOBT completion. In stage 2, we hypothesize that a lottery-based incentive and a raffle-based incentive will both lead to a statistically significant increase in the rate of FOBT completion compared to a fixed payment incentive with an equivalent dollar per patient value.


Eligibility criteria: Inclusion Criteria:

* PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period.

Exclusion Criteria:

* None. All PVAMC outpatients who are prescribed an FOBT kit in Module B or C during the study period will be eligible.

Primary outcomes:
measure: FOBT completion and return
timeFrame: 30 days
Secondary outcomes:
measure: FOBT completion rate among previously non-adherent patients and FOBT kit return time by arm
timeFrame: 30 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Philadelphia Veterans Affairs Medical Center
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center
name: Jeffrey T Kullgren, MD, MS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Corporal Michael J. Crescenz VA Medical Center
name: Steven C Marcus, PhD
role: STUDY_DIRECTOR
References:
citation: Kullgren JT, Dicks TN, Fu X, Richardson D, Tzanis GL, Tobi M, Marcus SC. Financial incentives for completion of fecal occult blood tests among veterans: a 2-stage, pragmatic, cluster, randomized, controlled trial. Ann Intern Med. 2014 Nov 18;161(10 Suppl):S35-43. doi: 10.7326/M13-3015.
Clinical trial NCT04739189: Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.
Official title: Appetite Response to Exercise- Versus Energy Restriction-induced Energy Deficit in Adolescents With Obesity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: appetite control
obesity
Adolescents
exercise
Energy Deficit
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Tza Nou - Maison médicale pour enfants et adolescentes
name: Laboratoire AME2P
First posted: 2021-02-04
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effect of iso-energetic energy deficits induced by exercise or dietary restriction on energy intake and appetite feelings in adolescents with obesity

Detailed description: The present study will compare the nutritional response to an energy deficit of 400 kcal induced once by realisation of an acute exercise set at moderate intensity and once by a dietary restriction imposed at lunch (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (CON); ii) one session with an exercise-induced energy deficit (Def-EX); iii) one session with an energy restriction-induced energy deficit (Def-EI).

Their ad libitum energy intake will be assessed during dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria: Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks

Primary outcomes:
measure: Change from different intervention of energy intake measured during an ad libitum buffet meal (in kcal)
timeFrame: day 1, day 8, day 15
Secondary outcomes:
measure: Hunger feelings
timeFrame: day 1, day 8, day 15
measure: Food reward
timeFrame: day 1, day 8, day 15
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Chu Clermont Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Valérie JULIAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04888689: Holter of Movement in Patients with Multiple Sclerosis in Controlled Environment.
Official title: Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Controlled Environment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Actimyo
Accelerometry
Motion laboratory
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: SYSNAV
name: Centre Hospitalier Régional de la Citadelle
First posted: 2021-05-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients undergo clinical evaluation while wearing Actimyo device to assess their gait.
Primary purpose: DIAGNOSTIC

Brief summary: ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.

This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.


Eligibility criteria: Inclusion Criteria:

* Confirmed MS diagnosis,
* Over 18 years old,
* Ambulant patients,
* Signed informed consent,
* No clinical and / or radiological relapse within 3 months.

Exclusion Criteria:

* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
* Any other previous or present pathology having an impact on motor function.
* Recent surgery or trauma (less than 6 months) in the upper or lower limbs

Primary outcomes:
measure: 95th centile of stride velocity
timeFrame: One day
measure: 50th centile of stride velocity
timeFrame: One day
measure: 95th centile of stride length
timeFrame: One day
measure: 50th centile of stride length
timeFrame: One day
measure: Stance phase time
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Centre Hospitalier Régional de la Citadelle
Study officials:
affiliation: CHR Citadelle-CHU liège
name: Margaux Poleur, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04750889: Breast Localization: RFID Tags vs Wire Localization
Official title: RFID Trial: Localization of Non-palpable Breast Lesions Using Radiofrequency Identification Tags or Wire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasm Female
Keywords: Non palpable breast cancer
RFID tags
Observational study
Surgery
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years of age or older patients requiring conservative surgical management for a breast lesion infra-clinical (fibroadenomas, papillomas, atypical lesions, neoplasia), whose histology will have been proven beforehand by anatomopathology

Brief summary: The RFID trial focuses on breast localization in patients with non-palpable breast cancers. It aims to demonstrate the improvement in patient comfort when using the Radio Frequency Identification (RFID) tag and LOCalizer™ device compared to the gold standard device.

Detailed description: It is an observational, prospective, single-center, 2-arm (RFID group vs. standard gold), non-randomized and category 3 comparative study. The RFID trial focuses on breast localization in patients with non-palpable breast cancers. These patients will benefit from a mastology consultation: consent will then be acquired. The RFID tag or the gold standard localization will be put in place during this consultation (one day before surgery).

Patients will fill in their questionnaire in two steps:

* during the installation of the device (RFID tag or wire localization) to evaluate the patient's pain,
* then at the 1-month post-operative consultation to assess pain in the interval until surgery Radiologists and surgeons will fill out the questionnaire dedicated to them after each procedure.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older,
* Requiring conservative surgical management for a breast lesion -infra-clinical (fibroadenomas, papillomas, atypical lesions, neoplasia), whose histology will have been proven beforehand by anatomopathology.
* Patients referred to mastology for preoperative identification by the surgeons
* Able to give informed consent to participate in the research.
* Affiliation to a Social Security regime

Exclusion Criteria:

* Multiple breast lesions
* Patients with breast neoplasia during pregnancy.
* Person deprived of liberty or under guardianship or incapable of giving consent
* Refusal to participate

Primary outcomes:
measure: Evaluation of the patients satisfaction
timeFrame: 1 years and 1 month
Secondary outcomes:
measure: Satisfaction of surgeons and radiologists assessed by a questionnaire
timeFrame: 1 years and 1 month
measure: Evaluation of the quality of the RFID tag device by analizing surgery data
timeFrame: 1 years and 1 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Centre Jean PERRIN
Study officials:
References:
Clinical trial NCT06241989: Digital Game Addiction and Cyberbullying in Adolescents
Official title: Motivational Interviewing Supported Health Education on Digital Game Addiction and Cyberbullying inAdolescents Impact on Behavior
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Level of Digital Game Addiction
Level of Cyberbullying
Keywords: digital game addiction
cyberbullying
adolescent
motivational interview
health education
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With the widespread use of technology and internet, digital game addiction and cyberbullying behaviors have increased among adolescents. Effective interventions are needed to prevent these behaviors. The aim of the study is to determine the effect of health education supported by motivational interviewing on digital game addiction and cyberbullying behaviors in adolescents. The research will be conducted with a randomized controlled trial design. The intervention group will receive six sessions of motivational interviewing-supported health education. Within the scope of the intervention, the first two sessions will be health education and the last four sessions will be motivational interviewing. It is planned that each session will be 35 minutes and the sessions will be implemented one week apart.


Eligibility criteria: Inclusion Criteria:

* Continuing 9th grade education
* Volunteering to participate in the research
* Being given permission by their families to participate in the study

Exclusion Criteria:

* Having problems understanding and speaking Turkish
* Visual-hearing impairment
* Having a neuropsychiatric disease

Primary outcomes:
measure: Digital Game Addiction Scale-7
timeFrame: baseline
measure: Revised Cyberbullying Inventory-II
timeFrame: baseline
measure: Digital Game Addiction Scale-7
timeFrame: first week
measure: Revised Cyberbullying Inventory-II
timeFrame: first week
measure: Digital Game Addiction Scale-7
timeFrame: twelfth week
measure: Revised Cyberbullying Inventory-II
timeFrame: twelfth week
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Çankaya/Türkiye
Study officials:
References:
Clinical trial NCT03064789: Epidemiological Study in Subjects With Vulvovaginal Candidiases
Official title: Estudio epidemiológico de la evolución clínica y microbiológica en Pacientes Tratadas Por un Episodio Agudo de Candidiasis Vulvovaginal
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvovaginal Candidiases
Keywords: Candidiases
Vaginal Infections
Lead sponsor: Instituto Palacios
Sponsor class: OTHER
First posted: 2017-02-27
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with VVC symptomatology and positive culture

Brief summary: Epidemiological study about the clinical and microbiological progress in subjects under treatment for a severe vulvovaginal candidiases episody


Eligibility criteria: Inclusion Criteria:

* Sexually active women between 18 and 50 years of age at time of screening
* With diagnosis and symptomatology of VVC

Exclusion Criteria:

* Pregnant women
* Diabetes Mellitus
* Women witihin three months after a delivery or misbirth
* Women with vaginal or genital infection symptomatology other than candidiases that needs antibiotic treatment
* Vaginal probiotics use within last three months
* Undiagnosed abnormal genital hemorrhage

Primary outcomes:
measure: Estimate cure rate in women with severe vuvovaginal candidiases infection
timeFrame: At 3 months
Secondary outcomes:
measure: Estimate recurrences
timeFrame: At 6 months
measure: Estimate recurrences
timeFrame: At 12 months
measure: Evaluate the link between symptomatology and negative culture
timeFrame: At 3 months
measure: Evaluate the effectiveness of probiotic treatment by physician
timeFrame: At 3 months
measure: Evaluate the effectiveness of probiotic treatment by patient. A satisfaction questionnaire will be performed
timeFrame: At 3 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Instituto Palacios
Study officials:
affiliation: Instituto Palacios
name: Santiago Palacios, PI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00742989: Effect of Osteopathic Lymphatic Treatment on Plasma Volume, Protein Concentration and Albumin Concentration.
Official title: The Short-Term Effect of Osteopathic Lymphatic Treatment on Blood Cell Count, Plasma Protein, and Blood Pressure: A Pilot Study in a Cross-Over Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: osteopathic
lymphatic
treatment
OLT
normal
Lead sponsor: Kansas City University of Medicine and Biosciences
Sponsor class: OTHER
First posted: 2008-08-28
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The goal of this project is to see how much an osteopathic lymphatic treatment (OLT) causes an increase in plasma volume, total plasma protein concentration, and albumin concentration. This is an important step in understanding the effects of OLT, specifically its effects on fluid in the body. The primary role of the lymph system is the return of fluid and proteins lost from the blood vessels. Despite this, no research has been done to see what effects an OLT has on fluid and protein levels in the blood.


Eligibility criteria: Inclusion Criteria:

* Normal, healthy volunteers
* Males
* Age 20 to 40 years

Exclusion Criteria:

* History of cardiovascular, kidney, or liver disease.
* Cannot have taken medication or drugs or have been ill at the time of the study or for two weeks prior.

Primary outcomes:
measure: Baseline blood pressure
timeFrame: 15 minute
Secondary outcomes:
measure: Plasma proteins
timeFrame: 15 minute
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Dybedal Clinical Research Center, Kansas City University of Medicine and Biosciences
state: Missouri
Study officials:
affiliation: Kansas City University of Medicine and Biosciences
name: W. Evan Rivers, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Kansas City University of Medicine and Biosciences
name: Charlott L. Williiams, RN, CCRC
role: STUDY_DIRECTOR
affiliation: KCUMB
name: Alan G. Glaros, PhD
role: STUDY_DIRECTOR
affiliation: KCUMB
name: Kevin Treffer, DO
role: STUDY_CHAIR
References:
citation: Rivers WE, Treffer KD, Glaros AG, Williams CL. Short-term hematologic and hemodynamic effects of osteopathic lymphatic techniques: a pilot crossover trial. J Am Osteopath Assoc. 2008 Nov;108(11):646-51.
Clinical trial NCT00450489: Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients
Official title: Assessment of Quality of Life and Satisfaction With Medical Care of Pediatric Type 1 Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes Mellitus
Quality of Life
Satisfaction of medical care delivery
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2007-03-22
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children cared for Type 1 Diabetes Mellitus, in Children's Mercy Hospital and Clinics, Endocrine Clinic.

Brief summary: The purpose of this study is to evaluate the change score for the PedsQL short form Diabetes and Core Modules and the Patient Assessment of Chronic Illness Care measured at baseline (before changing care delivery models) and 12 months after transitioning to the team model of care delivery.

Detailed description: Pediatric Type 1 Diabetes Mellitus patients and their parents will complete the forms before and 12 months after the diabetes clinic at Children's Mercy Hospital in Kansas City, MO transitions to a team model of care delivery.

Eligibility criteria: Inclusion Criteria:

* Type 1 Diabetes Mellitus six years of age and older who are receiving care in the diabetic clinic at Children's Mercy Hospital

Exclusion Criteria:

* T1 Diabetes Mellitus patients not receiving care in the diabetes clinic at Children's Mercy Hospital or not meeting the age requirements

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
Study officials:
affiliation: Children's Mercy Hospital Kansas City
name: Kurt Midyett, MD
role: PRINCIPAL_INVESTIGATOR
References: