louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01818076: Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Skin Aging
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-26
Enrollment: 311
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe crow's feet lines
* Female or male, 18 years of age and above and in good general health
* Women of childbearing potential must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active skin disease or irritation at the treatment area
* Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
* Treatment with botulinum toxin type A for crow's feet lines in the last 3 months
* Chemical peel during the 9 months prior to treatment
* Use of prescription retinoid products during the 3 months prior to treatment

Primary outcomes:
measure: Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments
timeFrame: Up to 24 months
measure: Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Nashville Centre for Laser and Facial Surgery
state: Tennessee
Study officials:
References:
Clinical trial NCT01277276: Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
Official title: Study of Chemotherapy Side Effects in Cancer Patients: Non-invasive Optical Measurements of the Brain
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Signs and Symptoms
Keywords: Medical tool
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2011-01-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic, community sample

Brief summary: Currently there is no methodology that can assign a risk of development of chemo brain and thus, studies to understand how and why only some patients develop chemo brain along with studies of potential treatments face major hurdles. This study will define hemodynamic/optical parameters in normal individuals and cancer patients undergoing chemotherapy potentially identifying optical parameters that are associated with the development of chemo brain, leading to new insights into the origin of the chemo brain condition, and importantly potentially identifying parameters that may predict who will develop "chemo brain" in order to directing investigations of therapies.

Detailed description: The researcher can use Non-invasive optical imaging, diffuse optical spectroscopic imaging, measure various tissues and can determine chemo brain symptoms. Near infrared diffuse optical imaging is a real-time, non-invasive technique that measures hemodynamic variations based on changes in hemoglobin oxygenation. Tissue in general and the cerebral cortex surface in particular, are transparent to near infrared light.

Direct optical measurement of cerebral hemodynamic parameters is superior to systemic approaches that infer brain levels of hemoglobin. Optical imaging in conjunction with physiologic maneuvers measures vascular tone and reactivity and may permit early detection of changes in physiology that precede the onset of chemo brain symptoms. Since chemo brain specifically impacts working memory and executive function the optical imaging can measure the frontal cortical areas behind the forehead.

Eligibility criteria: Inclusion Criteria:

* have a histologically proven cancer.
* Planned initiation of chemotherapy
* age range between 18-70 years

Exclusion Criteria:

* have NO a histologically proven cancer.
* NO planned chemotherapy
* age less than 18 years

Primary outcomes:
measure: Measurement of brain tissues blood flow
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: Edward Nelson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beckman Laser Institute University of California Irvine
name: Bruce Tromberg, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04936776: Pediatric Vaccinations
Official title: Pediatric Vaccinations
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pediatric ALL
Vaccination
Immunization
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-06-23
Enrollment: 1203
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.

Brief summary: As the Covid-19 pandemic hit New York City in the spring of 2020, many families were home-bound due to the city-wide lockdown. As a result, families in New York City were unable to attend their child's healthcare appointments and many young children did not receive their regularly-scheduled vaccinations. Parts of the city-wide lockdown did eventually lift in the summer of 2020 as positive Covid-19 virus rates declined in NYC. However, regularly scheduled vaccination rates (non-Covid-related) remain low. Yet, it is critical that young children receive their mandatory vaccines in a timely manner to decrease the chance of contracting preventable illnesses. Thus, the investigators seek to increase vaccination rates among children ages 0-2 years in Sunset Park Brooklyn.


Eligibility criteria: Inclusion Criteria:

* Children ages 0-2 years with delayed vaccinations (due for vaccine and due soon) in NYU Brooklyn Family Health Centers network.

Exclusion Criteria:

* Children above the age of 2 who do not attend NYU Brooklyn Family Health Centers network

Primary outcomes:
measure: Change in pediatric vaccination rate among children ages 0-2 years (proportion of vaccines due per person)
timeFrame: Baseline - 1 year
Secondary outcomes:
measure: Number of scheduled appointments
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Holly Krelle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05677776: The Relationship Between Covid-19 and Pneumothorax in Patients Hospitalized With Covid-19 During the Pandemic
Official title: The Relationship Between Covid-19 and Pneumothorax in Patients Hospitalized With Covid-19 During the Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Pneumothorax
Keywords: COVID-19
pneumothorax
Lead sponsor: Erol Olcok Corum Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: over 18 years , PCR testin positive COVID-19 patients

Brief summary: It is aimed to examine the retrospective features of covid-19 patients followed in our hospital with pneumothorax.

Detailed description: It is aimed to examine the retrospective features of covid-19 patients followed in our hospital with pneumothorax. The files of covid-19 patients with pneumothorax were reviewed retrospectively. The radiological records and treatment protocols of the patients were reviewed. The results were evaluated in terms of its relationship with pneumothorax.

Eligibility criteria: Inclusion Criteria:

* over 18 years
* covid-19 patient
* having a diagnosis of pneumothorax
* PCR test positive and lung tomography pneumonic involvement

Exclusion Criteria:

* PCR test negative

Primary outcomes:
measure: relationship between covid-19 and pneumothorax
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Çorum
country: Turkey
facility: Hulya TOPCU
Study officials:
affiliation: ÇorumTRH
name: Hilal BOYACI
role: STUDY_CHAIR
References:
Clinical trial NCT00554476: Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis
Official title: Comparison of Two Combined Therapeutic Methods for Treatment of Lateral Epicondylitis: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Lateral Epicondylitis
Keywords: Lateral Epicondylitis
Treatment
Corticosteroid
Elbow Cast
Icing
NSAIDs
Lead sponsor: Azad University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness of two combined therapeutic methods including corticosteroid injections with elbow cast versus ice massage and non-steroidal anti inflammatory drugs (NSAIDs).

Detailed description: Design: Randomized clinical trial. Setting: Boo-Ali and Baqyiatallah Hospital in Tehran. Patients: 50 randomly selected patients, in two groups of 25 subjects. Interventions: Corticosteroid injections with elbow cast versus icing and NSAIDs.

Outcome measures: Patients were evaluated for outcomes, complications and patients' satisfaction at 2nd, 4th, and 12th week after beginning of treatment. We measured the pain severity by Visual Analogue Scale (VAS).

Eligibility criteria: Inclusion Criteria:

* pain at the lateral side of the elbow
* pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension, or resisted extension of middle finger at the metacarpophalangeal joint
* pain to be continued for longer than 6 weeks or even with recurrent pain during similar period

Exclusion Criteria:

* previous history of receiving any treatment for lateral epicondylitis within 6 months prior to intervention
* patients who were unable to return for follow up
* patients with nerve entrapment
* pregnancy
* breast-feeding
* presence of systemic neuromuscular disorders such as myasthenia gravis
* upper limb fractures
* other arm/forearm pathology such as radial nerve compression
* known thrombocytopenia
* coagulopathy or bleeding diathesis
* history of diffuse pain syndrome
* history of inflammatory arthropathy
* intolerance/allergy to corticosteroids or NSAIDs or any contraindication for these
* untreated depression
* history of narcotic use for pain management greater than 1 month or history of narcotic abuse problem

Primary outcomes:
measure: visual analogue scale (VAS)
Secondary outcomes:
measure: Patient's satisfaction
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Azad University of Medical Sciences, Boo-Ali Hospital
Study officials:
affiliation: Department of Orthopedics, Boo-Ali Hospital
name: Jaleh Hassanloo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01235676: Tissue Composition of Newborn Infants of Obese and Lean Mothers
Official title: Is it Possible to Reduce the Number of Macrosomic Infants With Abundant Fat Tissue by Lifestyle Intervention During Pregnancy ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
lifestyle
pregnancy
newborn infant
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 270
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 0-hypothesis: the tissue composition of newborn infants is not modified by lifestyle intervention during pregnancy

Detailed description: Obese pregnant women (BMI \> 30) are randomized to exercise, diet or control (1:1:1) in order to reduce weight gain during pregnancy. Shortly after birth, tissue composition will be measured (DEXA)in 200 infants (65 from each group). The amount of fat tissue is subsequently analyzed between the groups and compared to results from another 65 infants of lean mothers

Eligibility criteria: Inclusion Criteria:

Healthy term neonates Informed and written consent from both parents -

Exclusion Criteria:

Sick or preterm infants No consent

-

Primary outcomes:
measure: amount of fat tissue
timeFrame: at birth
Secondary outcomes:
measure: birth weight
timeFrame: at birth
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
Clinical trial NCT04657276: Turkish Adaptation of Segmental Assessment of Trunk Control Scale
Official title: Turkish Adaptation, Validity and Reliability of Segmental Assessment of Trunk Control (SATCo) Into in Infants With Down Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Down Syndrome
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Down Syndrome

Brief summary: In infants with Down syndrome at risk in terms of neurosensory motor development retardation, the level of trunk control can determine the level of trunk control towards motor development in infants with down syndrome.

For this reason, the purpose of this study is to adapt the segmental assessment of trunk control scale to Turkish by evaluating the motor development in children with Down syndrome. It is the investigation of validity and reliability.

Detailed description: Independent sitting of babies with Down syndrome is very important because sitting is the primary position on improving play activities. It is a known fact that late acquisition of sitting posture has negative effects on gross motor skills such as crawling and walking as well as fine motor skills. The extent to which trunk development affects the developmental stages of the child and his performance in motor behaviors and skills should be evaluated. At the same time, trunk control should be evaluated at various periods in order to determine early intervention and treatment strategies in babies with Down syndrome who are at risk for motor development.

Eligibility criteria: Inclusion Criteria:

* Volunteer parents who have;
* Infant with down syndrome

Exclusion Criteria:

* Have a serious medical history (serious cardiac problems, infantile spasm, leukemia)
* Presence of MSS and PSS-related problems
* Those with visual and auditory problems
* Having epileptic seizures
* Presence of musculoskeletal problems

Primary outcomes:
measure: Segmental Assesment of Trunk Control
timeFrame: 20 minutes
measure: Gross Motor Function Measure (GMFM-88)
timeFrame: 30 minutes
Secondary outcomes:
measure: Pediatric Quality of Life Inventory-PedsQL
timeFrame: 15 minutes
measure: Alberta Infant Motor Scale
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Esra Kınacı Biber
Study officials:
References:
Clinical trial NCT03080376: Home Exercise Intervention in Childhood Obesity
Official title: Home Exercise Intervention in Childhood Obesity: Randomized Clinical Trial Comparing Print-based Versus Web-based Platform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Obesity
Keywords: Exercise
Web-based intervention
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 51
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: To evaluate the impact of a physical exercise Web-based program with or without support on body composition, physical fitness and blood pressure values.

Design: Randomized Controlled Trial. Population: Obese children and adolescents.

Detailed description: In recent years there has been a decline in levels of physical activity (PA) in both children and adults. The promotion of PA is also a key element in the treatment of obesity, along with changing eating habits, but usually has very low levels of adherence. Active video games may be an alternative for the promotion of PA in the treatment of obesity.

The objective of this project is to evaluate the impact of a physical exercise Web-based program with or without support on Body Composition, Physical Fitness and Blood Pressure values.

Eligibility criteria: Inclusion Criteria:

* Overweight or obese children and adolescents

Exclusion Criteria:

* Secondary obesity syndromes
* Severe obesity (z score \> 2.5)

Primary outcomes:
measure: Percentage of body fat
timeFrame: Change from Baseline Percentage of body fat at 3 months
Secondary outcomes:
measure: Hand strength
timeFrame: Change from Baseline Hand strength at 3 months
measure: Oxygen consumption peak
timeFrame: Change from Baseline Oxygen consumption peak at 3 months
measure: Blood pressure
timeFrame: Change from Baseline Blood Pressure at 3 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Moncada
Study officials:
affiliation: University CEU Cardenal Herrera
name: JF Lisón, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT02820376: Assessment of Differential Renal Function by CT in Living Donors
Official title: Assessment of Differential Renal Function by CT in Living Donors - The DOVISCAN Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Living Donor of Kidney
Keywords: 4D computed tomography
Kidney function tests
Living Donors
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: University of Lorraine
First posted: 2016-07-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess the degree of agreement of the measurement of differential renal function in living donors by CT (computed tomography) and SPECT (single photon emission computed tomography).


Eligibility criteria: Inclusion Criteria:

* Kidney living donor candidate (approval given) undergoing a morphological and functional renal assessment
* Mandatory enrollment in a health security plan (French Social Security)
* Subject having signed an informed consent

Exclusion Criteria:

* Contra-indications to computed tomography with iodinated contrast medium injection, or to scintigraphy
* Subjects with an abnormal urinary tract (unique kidney, ectopic kidney, horseshoe kidney)
* Subjets under a legal protection measure

Primary outcomes:
measure: degree of agreement
timeFrame: through study completion (2 years)
Secondary outcomes:
measure: Intra- and inter-observer reproducibility of CT DRF measurement
timeFrame: through study completion (2 years)
measure: Radiation dose exposure for each technique
timeFrame: 1 day
measure: Agreement between post-processing methods for CT
timeFrame: through study completion (2 years)
measure: Automatic post-processing for Patlak-Ruthland method
timeFrame: through study completion (2 years)
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Damien Mandry, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233076: Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.


Eligibility criteria: Inclusion Criteria:

* Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.
* Able to wear study lenses in the available powers from -1.00D to -6.00D.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury within twelve weeks of enrollment.
* History of corneal or refractive surgery.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Currently enrolled in any clinical trial.
* Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.
* Monovision correction during the study.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Vision Quality
timeFrame: 1 week of wear
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: