louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01982279: Longitudinal Measurement of Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
Official title: One Year Change in Caloric Compensation and Eating in the Absence of Hunger in French Preschool Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Caloric compensation
Eating in the absence of hunger
Preschool children
Maternal feeding practices
Maternal eating behavior
one year
children
Lead sponsor: Centre des Sciences du Goût et de l'Alimentation
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2013-11-13
Enrollment: 236
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population was composed of 236 children at inclusion. Among them, 98 participated in the three time of measurements of caloric compensation or eating in the absence of hunger.

Brief summary: Objectives: The aims were to measure one year change in caloric compensation (CC) and eating in the absence of hunger (EAH) in 3 to 6 year-old French children in their regular eating context and to link these change with individual characteristics (adiposity, age, gender) and maternal feeding practices.

Three series of measurements of caloric compensation (CC) and eating in the absence of hunger (EAH) were conducted: at baseline, and 3 (FU3M) and 15 (FU15M) months later. Each serie of measurement was composed of three consecutive weeks an identical lunch was served in four preschool canteens reaching 236 children. The first lunch was a control session. For the CC situation (week 2), thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH situation (week 3), ten minutes after lunch children were exposed to palatable foods (430 kcal). Food intake was measured at the individual level. Maternal eating behaviour and feeding practices were measured by questionnaires. Child's height and weight were measured by a medical doctor.


Eligibility criteria: Inclusion Criteria:

* To be registered to the school canteen, to provide parental approval at inclusion and at the FU15M

Exclusion Criteria:

* Chronic disease or food allergies

Primary outcomes:
measure: Change in caloric compensation in 15 months
timeFrame: one week
measure: Control measurement of energy intake at baseline
timeFrame: One week
measure: Change in eating in the absence of hunger in 15 months
timeFrame: one week.
measure: Control measurement of energy intake three months after baseline
timeFrame: One week
measure: Control measurement of energy intake fifteen months after baseline
timeFrame: One week
Secondary outcomes:
measure: Maternal feeding practices and eating behavior
timeFrame: one month after inclusion
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre des Sciences du Goût et de l'Alimentation
Study officials:
affiliation: Centre des Sciences du Goût et de l'Alimentation
name: Nicklaus Sophie, phD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01385579: Effectiveness of Direct-to-Patient Outreach on Colorectal Cancer Screening Within a Low Income and Diverse Population
Official title: A Randomized Controlled Trial of a Direct-to-Patient Outreach Program to Improve Rates of Colorectal Cancer Screening in a Low Income and Racially Diverse Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm of Large Intestine
Keywords: colorectal cancer screening
fecal occult blood testing (FOBT)
vulnerable populations
community health center
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-06-30
Enrollment: 202
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if the direct mailing of fecal occult blood testing (FOBT) kits to patients who are due for colorectal cancer screening is an effective way to improve colorectal cancer screening rates within a low income and racially/ethnically diverse population.

Detailed description: Patients ages 50 to 80 who are identified through the electronic health record as not being up to date on colorectal cancer screening are eligible for the study and will be randomly assigned to the intervention or usual care group. Individuals in the intervention group will be mailed a letter informing them that they are due for colorectal cancer screening, educational material regarding colorectal cancer screening, a fecal occult blood testing (FOBT) kit, directions on how to use and return the FOBT kit. The proportion of patients assigned to the intervention versus usual care groups who complete a guideline recommended form of colorectal cancer screening within 4 months of the initiation of outreach will be compared.

Eligibility criteria: Inclusion Criteria:

Ages 50 to 80 as of 12/31/2009 At least 2 visits to the community health center between 7/1/2008 and 12/31/2009

Exclusion criteria:

Documented fecal occult blood testing (FOBT) within 1 year (between 1/1/2009 and 12/31/2009) Documented sigmoidoscopy within 5 years (between 1/1/2005 and 12/31/2009) Documented colonoscopy within 10 years (between 1/1/2000 and 12/31/2009)

Primary outcomes:
measure: Completion of a Colorectal Cancer Screening
timeFrame: within 4 months of the initiation of outreach (by June 30, 2010)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Heartland International Health Center
state: Illinois
Study officials:
affiliation: Northwestern University, Feinberg School of Medicine, Department of Family and Community Medicine
name: Bechara N Choucair, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jean-Jacques M, Kaleba EO, Gatta JL, Gracia G, Ryan ER, Choucair BN. Program to improve colorectal cancer screening in a low-income, racially diverse population: a randomized controlled trial. Ann Fam Med. 2012 Sep-Oct;10(5):412-7. doi: 10.1370/afm.1381.
Clinical trial NCT05765279: A Study to Assess the Efficacy of HH-120 Nasal Spray for Prevention of SARS-CoV-2 Infection in Adult Close Contacts of Individuals Infected With SARS-CoV-2
Official title: An Investigator Initiated Clinical Study To Evaluate the Efficacy and Safety of HH-120 Nasal Spray as Post Exposure Prophylaxis (PEP) Regimen in Adult Close Contacts of Individuals Infected With SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2 Infection
Lead sponsor: Beijing Ditan Hospital
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An Investigator-initiated, Randomized, Single-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of SARS-Cov-2 Post Exposure Prophylaxis and Safety of HH-120 nasal spray


Eligibility criteria: Inclusion Criteria:

* Participants aged 18 to 65 years.
* Participants who have close contact with a SARS-CoV-2 infected individual (index case) are required to be randomized within 72 hours upon close contact.
* Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.

Exclusion Criteria:

* Have a history of severe allergy or hyper-sensitivity to inhaled allergen.
* Pregnant or breastfeeding women.
* Have participated, within the last 180 days prior to the screening, in a clinical study involving an investigational intervention of SARS-CoV-2 neutralizing antibody.
* Have other conditions not suitable for the study per investigator's discretion.

Primary outcomes:
measure: Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection.
timeFrame: Day 1 to Day 10
Secondary outcomes:
measure: Proportion of subjects who have a symptomatic RT-qPCR confirmed SARS-CoV-2 infection.
timeFrame: Day 1 to Day 10
measure: Proportion of subjects who have an asymptomatic RT-qPCR confirmed SARS-CoV-2 infection.
timeFrame: Day 1 to Day 10
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital,Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT03746379: Investigation of the Relationship Between Sensory Processing and Kinesychophobia in Fibromyalgia Patients
Official title: Investigation of the Relationship Between Sensory Processing and Kinesychophobia in
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fybromyalgia
Keywords: kinezyhophobia
sensory processing
fybromyalgia
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with fibromyalgia

Brief summary: Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain. In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders. Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury. The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.

Detailed description: Fibromyalgia; is a chronic and rheumatic condition characterized by diffuse pain. In patients with fibromyalgia syndrome, there is an increase in psychiatric symptoms, especially depression, anxiety, and somatoform disorders. Kinesophobia is defined as anxiety against pain and pain caused by painful injury and re-injury. The aim of this study was to investigate the relationship between kinesophobia and sensory processing in patients with fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* Diagnosed by fibromyalgia
* No other known physical, neurological and psychological illness
* Literate
* Volunteers to participate in the study

Exclusion Criteria:

* Not compliant with inclusion criteria

Primary outcomes:
measure: Sensory processing assessed with the Sensory Adolescent / Adult Sensory Profile Questionnaire
timeFrame: at the end of the third month
measure: Knesychophobia assessed with the Tampa Kineshiophobia Scale
timeFrame: at the end of the third month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02931279: PASS OCT® Post-market Clinical Follow-up
Official title: Evaluation of the Efficacy and Safety of the Cervical Posterior Fixation System PASS OCT®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intervertebral Disc Disease
Spondylolisthesis
Spinal Stenosis
Spinal Neoplasms
Spinal Fractures
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2016-10-13
Enrollment: 40
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: Patient who need immobilization and stabilization of spinal segments as an adjunct to fusion of the occipital, cervical and/or upper thoracic spine (Occiput-T3).

Brief summary: Prospective, multicenter non comparative and observational study (post-market clinical follow-up).

Patients operated with PASS OCT® manufactured by MEDICREA® INTERNATIONAL between July 2016 and July 2017.

The inclusion period will be 12 months and the follow-up 24 months

Detailed description: The primary endpoint is to evaluate the safety of the PASS OCT® system.

The secondary endpoints are to analyze the efficacy of the system with several point of view:

* The quality of fusion and the time of fusion through X rays
* the pain with VAS
* the quality of life thanks to questionnaires: NDI (Neck Disability Index) and JOA for myelopathy
* the daily of the patient: return to work, sport
* the surgeon satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patient with

  * degenerative disc disease or,
  * spondylolisthesis, or
  * spinal stenosis, or
  * trauma, or
  * atlanto-axial fractures with instability or
  * cervical tumors.
* Patient operated with PASS OCT®
* Patient \> 18 years
* Patient affiliated to health care insurance (social security in France)
* Patient able to complete a self-administered questionnaire
* Patient able to understand the protocol and the planning visit
* Patient able to sign an informed consent form

Exclusion Criteria:

* Patient unable or unwilling to sign an informed consent form
* Patient unable to complete a self-administered questionnaire
* Pregnant patient or intending to get pregnant within the next 3 years
* Patient judged as non-compliant by the investigator or not able to come back for follow-up visits

Primary outcomes:
measure: Adverse events
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Fusion
timeFrame: 1-6 months, 12 months, 24 months postoperatively
measure: Disability
timeFrame: 1-6 months, 12 months, 24 months postoperatively
measure: Quality of life
timeFrame: 1-6 months, 12 months, 24 months postoperatively
measure: Pain
timeFrame: 1-6 months, 12 months, 24 months postoperatively
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital la Timone
Study officials:
affiliation: Hopital la Timone, Marseille
name: Stephane Fuentes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06581679: Adenomyosis and Pregnancy: Levonorgestrel vs. GnRH for Blastocyst Transfer
Official title: Treatment of Infertile Adenomyosis Patients Using Levonorgestrel-releasing Intrauterine System or Gonadotropin-releasing Hormone Agonist Before Frozen Blastocyst Transfer Improves Manifestations and Increases the Chances of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenomyosis
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2024-09-03
Enrollment: 184
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adenomyosis is a condition where endometrial tissue grows into the uterine muscle, causing symptoms like pelvic pain, heavy bleeding, and infertility. This abnormal growth can lead to a variety of reproductive issues, including a higher risk of miscarriage and early pregnancy loss.

While there are treatments available for adenomyosis, they are often limited due to the lack of precise diagnostic criteria. One common approach is the use of gonadotropin-releasing hormone agonist (GnRHa), which can improve pregnancy rates in infertile women with adenomyosis. However, it's important to note that GnRHa may not restore pregnancy rates to baseline levels.

Another potential treatment option is the levonorgestrel-releasing intrauterine system (LNG-IUS). This device releases a hormone called levonorgestrel into the uterus, which can help control the symptoms of endometriosis and adenomyosis. Studies have shown that the endometrial concentration of levonorgestrel from the LNG-IUS is significantly higher than in other tissues like the myometrium, fallopian tubes, and fat tissue.


Eligibility criteria: Inclusion Criteria:

* Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in good-quality FE.

Exclusion Criteria:

* Women Women who have adenomyosis diagnostic characteristics and underwent ICSI that resulted in Poor-quality FE.

Primary outcomes:
measure: Adenomyosis Treatment
timeFrame: 6 monthes
measure: Increase in Chemical and Clinical Pregnancy Rates
timeFrame: 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
state: Ash Sharqia Governorate
Study officials:
References:
Clinical trial NCT04922879: Early Lung Rehabilitation Care for Patients After Double Lung Transplantation
Official title: Early Lung Rehabilitation Care for Patients After Double Lung Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: experience summary
Primary purpose: SUPPORTIVE_CARE

Brief summary: Develop appropriate individual programs for patients to implement lung rehabilitation safely and effectively.

Detailed description: Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.

Eligibility criteria: Inclusion Criteria:

* Patients after double lung transplantation; informed consent

Exclusion Criteria:

* unstable condition

Primary outcomes:
measure: ICU hospital stay
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: SAHZhejiangU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Fei Zeng
role: STUDY_CHAIR
References:
Clinical trial NCT06499779: Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study
Official title: Prescription of Valproate and Derivatives in Women of Childbearing Age: Qualitative Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psychiatric Disorder
Keywords: Psychiatric disorder
Valproate
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subject female (≥16 years old) having prescription of Valproate and/or derivatives (Sodium Divalproate, Valpromide, Valproic Acid, Sodium Valproate) in an indication of psychiatric disorder for the period from January 1, 2021 to December 31, 2022,

Brief summary: The prescription of valproate in women of childbearing age has decreased by 82% in France, for mood disorders. Exposure to valproate during pregnancy 60%. However, the ANSM sent an alert document in August 2022 because there are still patients on valproate. In addition, there were 32 births taking valproate to mothers with bipolar disorder in 2018. The risks of exposure during pregnancy which occur in 10% of exposure cases are: congenital malformations; neurodevelopmental disorders including autism spectrum disorders, attention deficit disorders more or less hyperactivity, language disorders, motor disorders, mental delays; reduction in social, attentional, motor and language abilities; a lower level of education.


Eligibility criteria: Inclusion Criteria:

* Subject (≥16 years old)
* Female gender
* Prescription of Valproate and/or derivatives (Sodium Divalproate, Valpromide, Valproic Acid, Sodium Valproate) in an indication of psychiatric disorder for the period from January 1, 2021 to December 31, 2022,
* Subject not opposing, after information, the reuse of their data for the purposes of this research
* Holders of parental authority who do not object, after information, to the reuse of their child's data for the purposes of this research

Exclusion criteria:

* Subject and/or holder of parental authority having expressed opposition to participating in the study
* Impossibility of providing the subject with informed information (difficulties in understanding the subject, etc.)

Primary outcomes:
measure: Cause of valproate prescription in women of childbearing age
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Psychiatrie 2 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00690079: Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Caucasian Young and Elderly Subjects After Oral Multiple Doses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Pain
Keywords: MAD
Multiple ascending dose
Chronic pain
pain
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-04
Enrollment: 69
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.


Eligibility criteria: Inclusion Criteria:

* Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit.
* Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg
* Clinically normal physical findings including heart rate \> 45 bpm and laboratory values and normal resting ECG

Exclusion Criteria:

* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study.
* History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity.
* Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.

Primary outcomes:
measure: Safety AEs and vital signs
timeFrame: During the whole study
measure: ECG-recordings
timeFrame: ECGs (5 minutes) Days 1 and 12. 2 ECGs (5 minutes) Days 3, 6 and 10. 1 ECG (5 minutes) Days 2 and 13.
Secondary outcomes:
measure: PK
timeFrame: Days 1, 5 and 12, 12 times each day. Days 4, 6, 8, 10 and 14, once. Days 2, 3, 7, 9, 11 and 13 twice.
Other outcomes:
Locations:
city: Macclesfield
country: United Kingdom
facility: Research Site
state: Cheshire
Study officials:
affiliation: Emerging Analgesia TA AstraZeneca R&D Södertälje, Sweden
name: Rolf Karlsten
role: STUDY_DIRECTOR
affiliation: AstraZeneca Alderly Park1G61 Mereside, Alderly Park, Macclesfeld, Cheshire, England SK104TG
name: Ray Chetty
role: PRINCIPAL_INVESTIGATOR
References: