louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06517927: Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10
Official title: Prevalence of Long-term Dental Effects of Chemotherapy in Childhood Cancer Survivors Diagnosed With Cancer Before the Age of 10
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy Effect
Dental Caries
Malocclusion
Childhood Cancer
Tooth Defect
Keywords: Childhood cancer survivors
Dental defect
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 142
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventionnal study, cohort study
Primary purpose: DIAGNOSTIC

Brief summary: To date, there are no methods for assessing the risk of oral developmental defects that could predict long-term adverse effects in childhood cancer survivors. Having such a method at our disposal would enable us to better assess the risk to develop those defects and will help us provide new prevention and treatment strategies to ensure a healthy oral development.

The aims of this study are :

* Assess the caries risk in childhood cancer survivors compared with a control group.
* Assess the dental development defects risk in childhood cancer survivors compared with a control group.

Detailed description: This will be an international study comparing the Childhood Cancer Survivors (CCS) and a control group.

A questionnaire will be provided to the patients to gather information. A standard of care dental examination will then take place in a dental office in the Cliniques Universitaires Saint-Luc. We also collect medical data to complete the files.

Eligibility criteria: Inclusion Criteria:

* age below 10 at cancer diagnosis (for the CCS group).
* Chemotherapy must have been used to treat the patient (For the CCS group).
* The patient is 12 years old or older at the time of the follow-up appointment of the present study

Exclusion Criteria:

* A patient who was diagnosed and treated after 10 years old.
* Patient below 12 years old at time of study recruitment
* Patients with syndrome or diseases that involve teeth impairment\*
* Pregnant patient
* Refusal or inaptitude to undergo dental and radiographic examination

Primary outcomes:
measure: Assessment of the caries experience by using the Decay Missing Filled Teeth score (DMFT)
timeFrame: Thoughout the entire study, approximately during 2 years
Secondary outcomes:
measure: Assessment of the prevalence of dental development defects (DDD)
timeFrame: Thoughout the entire study, approximately during 2 years
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Maëlle De Ville de Goyet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00764127: The Development of an Eating Laboratory for Overweight Adolescents
Official title: The Development of an Eating Laboratory for Overweight Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Obesity
Keywords: adolescent
obesity
bariatric surgery
eating
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2008-10-01
Enrollment: 36
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: The purpose of the study is to develop methods to evaluate the eating behavior of adolescents, including overweight, normal weight, and candidates for adolescent bariatric surgery.

Detailed description: The purpose of this study is to examine the eating behavior, meal-related perceptions and meal-related hormones in overweight adolescents, normal weight adolescents and overweight adolescents who are undergoing bariatric surgery. Subjects will be asked to consume a single-item breakfast meal of a fixed amount (Ensure) and a multiple-item meal from a luncheon buffet. During the single-item meal, subjects will fill out questionnaires assessing subjective responses to the meal (e.g. hunger, fullness, pleasantness) and blood samples will be taken before, during, and after the meal to assess hormonal responses to the meal. The multiple-item meal will permit an assessment of total caloric consumption, food and macronutrient choice and rate of eating. Overweight adolescents undergoing bariatric surgery will be asked to do the meal studies 1 to 3 months before and 3 to 6 months after their surgery. Some bariatric surgery patients will only be studied after their after their surgery.

The data gathered from these pilot subjects will be used to further develop and refine our future studies on assessing eating behavior in overweight adolescents.

Eligibility criteria: Inclusion Criteria:

* BMI Index Enrollment in bariatric surgery program Ages 12-18

Exclusion Criteria:

* Pervasive developmental or psychological disorder Current use of weight loss medication Clinically significant medical condition Pregnancy Food allergy to single-item meal

Primary outcomes:
measure: Caloric intake
timeFrame: post-meal
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Michael Devlin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sysko R, Devlin MJ, Schebendach J, Tanofsky-Kraff M, Zimmerli E, Korner J, Yanovski JA, Zitsman JL, Walsh BT. Hormonal responses and test meal intake among obese teenagers before and after laparoscopic adjustable gastric banding. Am J Clin Nutr. 2013 Nov;98(5):1151-61. doi: 10.3945/ajcn.113.061762. Epub 2013 Aug 28.
Clinical trial NCT03121573: Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
Official title: Efficacy and Safety of Duloxetine Among Individuals With Depressive Disorder in a 12 Weeks Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: near infrared spectroscopy, NIRS, duloxetine
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2017-04-20
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study was to investigate the effects of duloxetine on improvement of brain cortical activity in patients suffering from major depressive disorder using near infrared spectroscopy.


Eligibility criteria: Inclusion Criteria:

* HAMD-17 more than 12 points
* Participants could understand this study and sign permit
* Participants could receive NIRS measurements
* Participants could comply with the protocol of the study

Exclusion Criteria:

* alcohol or substance abuse within 3 months of the study
* ever participate other clinical study related to duloxetine
* previous poor treatment effects of duloxetine
* concomitant use of MAOi within 14 days
* concomitant use of Linezolid
* with uncontrolled glaucoma

Primary outcomes:
measure: Change in Depression severity
timeFrame: 0-2-4-8-12 weeks
Secondary outcomes:
measure: Change in Brain cortical activity
timeFrame: 0-2-4-8-12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01891773: Improving Pediatric Asthma Care Through Inhaled Steroids in Schools
Official title: Improving Pediatric Asthma Care Through Inhaled Steroids in Schools (ISIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Inhaled Corticosteroids
School Nurses
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 48
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Asthma is the most common chronic pediatric disease in the United States, and is the most common cause of school absenteeism due to a chronic disease. Socioeconomically disadvantaged minority children receive disproportionately poor asthma care and incur a disproportionate share of asthma-related morbidity. The District of Columbia is particularly severely affected, with a lifetime asthma prevalence rate among children 0-17 years of age in 2010 of 22%, more than double the national average.

One of the major challenges in treating asthma is poor adherence to daily controller medications, particularly inhaled corticosteroids (ICS) which are the cornerstone of the NIH guidelines for asthma management. In an attempt to overcome poor compliance, investigators in Rochester, New York have partnered with primary care providers in their community to arrange for ICS administration at school by school nurses, and this approach yielded significant improvements in several asthma outcomes.

The investigators propose to collaborate in a pilot research project with the overall goal of improving asthma outcomes through reducing barriers to medication adherence. Specifically, the investigators aim to improve adherence to controller medications (inhaled corticosteroids - ICS) among DC children with asthma through the following activities:

1. A pilot prospective randomized clinical trial of home vs. school administration of ICS among DC children in grades kindergarten-8 with persistent asthma.
2. Qualitative interviews with nurses from DC public and public charter school to identify key barriers to administration of daily controller medications in the school setting


Eligibility criteria: Inclusion Criteria:

* Current enrollment in one of the grades K-8 at a DC public school (DCPS) or DC public charter school (DCPCS)
* Active public insurance
* Persistent asthma
* An Asthma Action Plan including daily ICS
* Child's primary asthma caregiver present, meaning the person who usually takes care of his/her asthma at home and can answer questions about his/her medical history.

Exclusion Criteria:

* Chronic disease of the cardio-pulmonary system other than asthma
* Non-English speaking parent/guardian
* Currently enrolled in in another asthma study

Primary outcomes:
measure: Proportion of doses received
timeFrame: 60 day treatment period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's National Research Institute
name: Stephen Teach, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00581373: Water and the Gastropressor Response - Diurnal Variability
Official title: Water and the Gastropressor Response - Diurnal Variability (Specific Aim 1.3)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Orthostatic Hypotension
Keywords: water
orthostatic hypotension
blood pressure
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2007-12-27
Enrollment: 20
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: TREATMENT

Brief summary: We will test the null hypothesis that there is no diurnal (morning to afternoon)variability in the blood pressure response to the ingestion of water 16 oz.


Eligibility criteria: Inclusion Criteria:

* orthostatic intolerance

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: blood pressure
timeFrame: 1 day
Secondary outcomes:
measure: heart rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01612273: The Effect of Triflusal on Peripheral Microcirculation Dysfunction
Official title: The Effect of Triflusal on Peripheral Microcirculation Dysfunction: A Double-Blind, Randomized, Controlled, Crossover Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vasospastic Syndrome
Keywords: Vasospastic syndrome
Vascular dysregulation
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 92
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To explore the efficacy of triflusal in patients with symptomatic peripheral microcirculation dysfunction. Triflusal is a salicylate compound approved in several countries as antithrombotic agent and it additionally has vasodilatory effect. The hypothesis is to explore if there is a improvement of peripheral microcirculation by triflusal.


Eligibility criteria: Inclusion Criteria:

* Between 40 and 70 years of age
* Diagnosed vasospastic syndrome with nailfold capillaroscopy (Fingertip is subjected to carbon dioxide at -15°C for 60 seconds. People found to have a blood-flow standstill of at least 12s in one or more capillaries were defined as having vasospasticity)
* More than seven points in 10-question interview provided by Nagashima et al.
* Written informed consent

Exclusion Criteria:

* Prior documented diabetes
* Overt peripheral artery disease
* Pregnant or nursing
* bleeding tendency
* Any contraindication of antiplatelet agent
* Thrombocytopenia (platelet \< 100,000mm3)
* Chronic liver disease (ALT \> 100 IU/L or AST \> 100 IU/L) or renal dysfunction (creatinine \> 4.0 mg/dl)
* Patients who can not stop to take aspirin

Primary outcomes:
measure: Primary Outcome - The amount of blood flow measured by finger doppler ultrasonography. The improvement of subjective symptom measured by questionaire.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, severance hospital
Study officials:
References:
Clinical trial NCT03611673: At-Home Olfactory Training
Official title: At-Home Olfactory Training With Essential-Oil Based Scents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Olfactory Disorder
Keywords: sense of smell
smell test
at-home smell test
essential oil
olfactory loss
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the impact of a twice daily at-home olfactory training program with a twenty scent, essential oil-based smell test in patients with olfactory dysfunction.

Detailed description: This study randomizes participants to receive either a four scent or fourteen scent olfactory retraining protocol. Baseline olfaction will be tested with a currently commercially available smell test as well as an essential oil based smell test. The protocol involves twice daily retraining where the participant inhales the scent and makes a mental note of what they should be smelling. The training period is six months total with a visit at 3 months to re-assess smell function as well as at six months.

Eligibility criteria: Inclusion Criteria:

* Have clinical olfactory dysfunction

Exclusion Criteria:

* Pregnant women
* Unable to perform routine follow-up
* Current participation in another clinical trial during this trial
* Patients with dementia, Alzheimer's disease, Parkinson's disease, or other neurocognitive disorders
* Diagnosis of other systemic conditions known to impact the sinonasal cavity such as Wegener's granulomatosis, Churg Strauss, and immunodeficiency
* Patients who are allergic to any of the smells or components of our olfactory testing
* Chronic rhinosinusitis, malignant tumors and/or oncologic therapies (radiation/chemotherapy)
* History of surgery on the nose or paranasal sinuses
* Patients using medications that may impact olfactory function (i.e. corticosteroids)

Primary outcomes:
measure: Change in ability to detect odorants - Sniffin' Sticks
timeFrame: Change from Baseline to Month 6
measure: Change in ability to detect odorants - AROMA
timeFrame: Change from Baseline to Month 6
Secondary outcomes:
measure: Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS)
timeFrame: Change from Baseline to Month 6
measure: SF-12 (Short Form Health Survey)
timeFrame: Change from Baseline to Month 6
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Jennifer Villwock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175173: Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lennox-Gastaut Syndrome
Keywords: Epileptic encephalopathy, Lennox-Gastaut type
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 707
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Lennox-Gastaut Syndrome

Brief summary: This surveillance's objectives are

1. Unknown adverse reactions
2. Incidences of adverse drug reaction
3. Efficacy during long-term administration
4. Factors considered to have effect to safety and effectiveness
5. Incidences of status epileptics, skin disorders and hyper sensitivity reaction, and central nervous system-related adverse events(ataxia , somnolence and/or dizzy, etc.)


Eligibility criteria: All patients with Lennox-Gastaut syndrome and administrated Inovelon

Primary outcomes:
measure: Investigations on adverse events and adverse drug reactions
timeFrame: Up to 2 years
Secondary outcomes:
measure: Frequency of attacks
timeFrame: 12 weeks and every 6 months up to 2years
measure: Overall assessments of the improvement in the seriousness of seizures
timeFrame: 12 weeks and every 6 months up to 2years
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
References:
Clinical trial NCT03953573: Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
Official title: Management of Post-delivery Pain and Its Impact on Resumption of Sexuality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sexuality
Delivery
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primiparous women, delivery at hospital.

Brief summary: Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality.

Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.


Eligibility criteria: Inclusion Criteria:

* Primiparous woman
* Age between 18 and 45 years old
* Delivery after 37 weeks of amenorrhea
* Speaking French
* Pregnancy, delivery and new-born examination without morphologic or biometric abnormalities, respiratory distress and no pathology discovered at neonatal screening on day 3
* Heterosexual woman with partner
* Signed consent
* Affiliate of national health insurance scheme

Exclusion Criteria:

* Multiple pregnancy,
* BMI \> 30
* Conjugopathie
* Known psychiatric history
* Medical history with gynecologic impact
* Surgery history with gynecologic impacts
* Hysterectomy post-delivery
* Protected by French law

Primary outcomes:
measure: Post-delivery sexuality resumption
timeFrame: 3 months
Secondary outcomes:
measure: Discussion with healthcare professional on post-delivery sexuality
timeFrame: 1 month
measure: Pain post-delivery
timeFrame: 3 months
measure: Sexual health
timeFrame: 3 months
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
Study officials:
References:
Clinical trial NCT00187473: Natural History of Hepatitis C in Patients With Normal Liver Tests
Official title: Determinants of Disease Severity in Patients With Chronic Hepatitis C and Normal Serum Aminotransferases (Normal Liver Tests)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis C
Keywords: hepatitis C
HCV
natural history
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCV patients with normal ALT

Brief summary: The Major goals of this project was to assess the natural history of disease in chronic hepatitis C patients with normal ALT and to determine the virologic and host factors associated with disease severity.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis C and persistently normal liver enzymes
* able to give consent

Exclusion Criteria:

* decompensated liver disease
* any prior antiviral or immunosuppressive therapy
* other liver disease besides hepatitis C

Primary outcomes:
measure: ALT
timeFrame: March 2015
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Mandana Khalili, MD
role: PRINCIPAL_INVESTIGATOR
References: