louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02923596: Retrospective Study of Keloid Disorder
Official title: Retrospective Study of Keloid Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Keloid
Keywords: Keloid
Lead sponsor: Tirgan, Michael H., M.D.
Sponsor class: INDIV
First posted: 2016-10-04
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients with a diagnosis of keloid

Brief summary: Purpose of this retrospective study is to review and analyze the information and data that has been already been generated during the course of routine practice of medicine by the investigators from 2007 up until Sept 1, 2016 from keloid patients who have sought medical care or medical advice for their keloid disorder.

Detailed description: To retrospectively review and analyze clinical data that has already been collected from keloid patients including photographs taken of keloid lesions during routine practice of medicine by the investigators 1) To better understand natural history of keloid disorder (KD), 2)To determine the ethnic incidence and prevalence of keloid, 3) To determine the rate of familial keloids, 4) To determine response to different treatment modalities, 5) To determine risk factors for development and worsening of keloid lesions.

Eligibility criteria: Inclusion Criteria:

* All patients must have at least one keloid lesion.
* Availability of photographic documentation of keloid lesion(s).

Exclusion Criteria:

* Lack of photographic documentation of keloid lesion(s)
* Lack of demographic data

Primary outcomes:
measure: Rate of development of massive, semi-massive and large Keloids
timeFrame: 1-5 years after surgery
Secondary outcomes:
measure: Rate of poor aesthetic outcome after ear surgery
timeFrame: 1-5 years after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Michael H. Tirgan MD
state: New York
city: San Antonio
country: United States
facility: Texas Institute of Dermatology
state: Texas
Study officials:
affiliation: Keloid Research Foundation
name: Michael H Tirgan, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01823796: Risk of Falls in Patients With Fibromyalgia
Official title: Assessment of Balance and Risk of Falls in Women With Fibromyalgia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Fibromyalgia
balance
falls
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with fibromyalgia. Fibromyalgia is a chronic condition characterised by chronic pain, fatigue, sleep disorders and psychological disturbances.

Brief summary: Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms: fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. The prevalence has been reported to be between 2 and 5%.

The hypothesis of this study is that women with fibromyalgia present high risk of falls and balance disorders compared with healthy women. The objective of this study was to investigate wether gait pattern changes in single and dual task conditions were associated with the risk of falling in women with fibromyalgia.

Detailed description: Falls and fall-related injuries are a common health problem. A fall is often a result of intrinsic physiological ageing and underlying chronic disease interacting with the external and challenging environment. Disturbances in physical function, muscle strength, range of motion, poor balance, affectation in sensory system, a loss of proprioception, alteration concerning visual and vestibular aspects, dizziness, decreased endurance and cognitive and mobility impairment are the most common risk factors for falls. Postural control in a dual task setting is especially relevant to daily life situations. Attending to that, we propose an assessment based on these parameters in women with fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with fibromyalgia attending to the Fibromyalgia Association of Granada.
* Women who can complete the assessment battery of tests and tasks.

Exclusion Criteria:

* Auditive and visual disturbances.
* Cognitive problems.
* Psychiatric pathology.
* Gait serious disturbances.
* Concomitant neurological conditions

Primary outcomes:
measure: Timed up & Go (TUG)
timeFrame: baseline
Secondary outcomes:
measure: Functional reach test
timeFrame: baseline
measure: Single leg stance
timeFrame: baseline
measure: Tinetti Test
timeFrame: baseline
Other outcomes:
measure: Barthel Index
timeFrame: baseline
Locations:
city: Granada.
country: Spain
facility: Faculty of Health Sciences. University of Granada.
state: Granada
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04298996: Effect of Passive Smoking on Oxidative Stress and Dental Caries in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oxidative Stress
Dental Caries
Passive Smoking
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
Collaborators: name: Kırıkkale University
First posted: 2020-03-06
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, referring for dental examination to the Department of Pediatric Dentistry of Kirikkale University, were selected.

Brief summary: The purpose of the present study was to determine the effect of passive smoking on oxidative stress and dental caries in children.A total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). Dental examination of children were performed and caries prevalence of the patients were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine levels' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained data parameters of the two groups were evaluated and comparison was performed.


Eligibility criteria: Inclusion Criteria:

-Systemically healthy children

Exclusion Criteria:

* Uncooperative children
* The presence of orthodontic/intraoral appliance
* Any disease or condition known to affect oxidative stress

Primary outcomes:
measure: determining oxidative stress marker in saliva: TAS
timeFrame: 1 day (once after the dental examination)]
measure: determining oxidative stress marker in saliva: TOS
timeFrame: 1 day (once after the dental examination)
measure: determining caries prevalence
timeFrame: 1 day (once for dental examination)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02984696: Total Antioxidant Capacity Before and After HRT in Hypotalamic Amenorrhea
Official title: Effects of 6 Months of HRT on Total Antioxidant Capacity in Patients Affected by Hypotalamic Amenorrhea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypothalamic Amenorrhea
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2016-12-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the effects of 6 months oh HRT on total anti-oxidant capacity, clinical, endocrine and metabolic features in women affected by hypotalamic amenorrhea. The study group included 20 patients treated with 1 mg of transdermal estradiol daily and 10mg of oral Medroxyprogesterone acetate from 16th to 24th day of therapy for six months. Menstrual pattern, anthropometric parameters, hormonal assays, DXA and bone metabolism parameters are evaluated before and after therapy.


Eligibility criteria: Inclusion Criteria:

* Hypotalamic Amenorrhea

Exclusion Criteria:

* diabetes mellitus (or impaired glucose tolerance as determined by a standard 75 gr oral glucose tolerance test)
* hypertension
* significant liver or renal impairment
* other hormonal dysfunction (hypothalamic, pituitary, PCOS, thiroidal or adrenal)
* neoplasms

Primary outcomes:
measure: Total Anti-oxidant Capacity
timeFrame: 6 Month
Secondary outcomes:
measure: Bone Mineral Density
timeFrame: 6 Months
measure: Osteocalcin
timeFrame: 6 Months
measure: Estrogen levels
timeFrame: 6 Months
measure: number of Cycles in 6 months
timeFrame: 6 Months
measure: beta crosslaps
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic university of Sacred Heart
Study officials:
References:
Clinical trial NCT00652496: Safety and Efficacy Study of Different Formulations of Bimatoprost Once-Daily in Patients With Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 249
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and efficacy of different formulations of bimatoprost ophthalmic solution compared with Bimatoprost 0.03% once-daily in patients with glaucoma or ocular hypertension. One of the test formulations was given to one eye and bimatoprost 0.03% given to the fellow eye of each patient


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or glaucoma in both eyes
* Require IOP-lowering therapy in each eye

Exclusion Criteria:

* Uncontrolled systemic disease
* Known allergy or hypersensitivity to bimatoprost

Primary outcomes:
measure: Intraocular pressure (IOP)
timeFrame: Day 5
Secondary outcomes:
measure: Patient Comfort
timeFrame: Days 1-4
measure: Patient Satisfaction
timeFrame: Day 5
measure: Treatment Preference
timeFrame: Day 5
Other outcomes:
Locations:
city: Wenatchee
country: United States
state: Washington
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02810496: Mutations of Glucocorticoid Receptor in Bilateral Adrenal Hyperplasia
Official title: Prevalence of Mutations of Glucocorticoid Receptors in Bilateral Adrenal Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Glucocorticoid Resistance
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: As the investigators observed a case of glucocorticoid mutation revealed by incidentally discovered bilateral adrenal nodular hyperplasia, it was postulated that this molecular anormality could be more frequent than previously described. To validate this hypothesis, it was decided to study 150 multicenter consecutive patients, presenting with incidentally discovered bilateral adrenal masses without clinical signs of Cushing's disease. In all these patients GR gene will be studied, mutations will be detected and described, functional disturbance will be tested. Usual polymorphisms will be described. Correlation between clinical signs, hormonal and morphological abnormalities and presence or absence of GR mutations will be searched.


Eligibility criteria: Inclusion Criteria:

* patients more than 18 years of age
* patients with bilateral adrenal masses

Exclusion Criteria:

* Refusing to participate in the study
* Protected by law
* Have obvious signs of Cushing's syndrome
* No progressive neoplastic disease

Primary outcomes:
measure: frequency of mutations
timeFrame: DAY 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
citation: Vitellius G, Delemer B, Caron P, Chabre O, Bouligand J, Pussard E, Trabado S, Lombes M. Impaired 11beta-Hydroxysteroid Dehydrogenase Type 2 in Glucocorticoid-Resistant Patients. J Clin Endocrinol Metab. 2019 Nov 1;104(11):5205-5216. doi: 10.1210/jc.2019-00800.
Clinical trial NCT03203096: Magnesium Supplementation in Stress Conditions
Official title: Randomized, Double-blind, Placebo-controlled Intervention Study About the Effects of Magnesium Supplementation Using Nutritional Supplements on the Stress Parameters of Students Preparing for Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Physiology
Keywords: magnesium, stress, metabolomics, heart rate variability
Lead sponsor: Protina Pharmazeutische GmbH
Sponsor class: INDUSTRY
Collaborators: name: Comenius University
First posted: 2017-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to determine how a 6-week magnesium supplementation with 400 mg magnesium from magnesium citrate/magnesium oxide affects stress parameters in students in exam preparation.

Detailed description: The examinations are carried out in 70 students in exam preparation (6 weeks before exam). The target parameters are determined in blood and 24h-urine. Blood sampling takes place at confinement, after 3 weeks and at the end of the study (week 6). In addition, heart rate variability is determined.

Eligibility criteria: Inclusion Criteria:

* healthy students in exam preparation

Exclusion Criteria:

* pregnancy
* any chronic diseases

Primary outcomes:
measure: blood sampling
timeFrame: 6 weeks
measure: 24h-urine
timeFrame: 6 weeks
measure: heart rate variability
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Martin
country: Slovakia
facility: Biomed Martin
Study officials:
References:
Clinical trial NCT01693796: Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
Official title: Evaluation of Thyroid Exposure to Radiation Doses During Paediatric Cardiac Catheterisations Performed for Diagnosis or the Treatment of Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Catheterizations
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 52
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the average risk for thyroid irradiation for any type of paediatric cardiac catheterization, based on the cummulative at-risk dose of 100 mSv, adjusted to the measured thyroid volume and to the patient's age.


Eligibility criteria: Inclusion Criteria:

* Inclusion of any patient (\< 18 year-old) with congenital heart disease undergoing one or more cardiac catheterization

Exclusion Criteria:

* Exclusion of patients with any type of thyroid dissease

Primary outcomes:
measure: exposure to radiation measure
timeFrame: 2 YEARS
Secondary outcomes:
measure: exposure to radiation measure
timeFrame: 2 YEARS
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_CHAIR
References:
Clinical trial NCT02855996: Evaluation of AVANCE Fathers in Action/Padres Activos Fatherhood Program
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fathers
Keywords: fatherhood
father involvement
economic stability
co-parenting
healthy relationships
father-child engagement
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 94
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The Child and Family Research Partnership (CFRP) will be conducting the "local" evaluation of AVANCE's Fathers in Action/Padres Activos (FA/PA) fatherhood program. AVANCE is a non-profit organization that has served low-income families and children since its founding in 1973. AVANCE sites have been providing fatherhood services for some time, but the programming offered has varied across sites and no rigorous evaluation of the programs has been completed. Through a federally-funded Responsible Fatherhood grant, AVANCE aims to create one fatherhood curriculum to be used across their sites: Fathers in Action/Padres Activos (FA/PA).

The purpose of the study is to advance the field of knowledge in the area of fatherhood programing by providing rigorous evidence on the impact of a comprehensive fatherhood program on enhancing a father's ability to be involved with and parent his child, in addition to providing more information on the selective characteristics of fathers who choose to participate in fatherhood programs. The study will seek to answer the following research questions: (1) What are the demographic and relationship characteristics of fathers who choose to participate in the Fathers in Action/Padres Actívos (FA/PA) program, and how do these characteristics compare to the fathers associated with mothers and children in other AVANCE programs?; (2) Does the FA/PA program positively impact parenting and co-parenting, father engagement and involvement, and healthy relationship?; (3) Are the program impacts similar for low-income fathers across regions (Houston v. the Rio Grande Valley), race/ethnicity (African American v. Hispanic), and coresidential status (nonresident v. resident)?; and (4) What are the factors that enhance or impede the successful implementation of the FA/PA program?


Eligibility criteria: Inclusion Criteria:

* Fathers (biological, adoptive, or social) over 18 years of age
* Able to travel to program location to attend classes

Exclusion Criteria:

* Under 18 years of age
* Female

Primary outcomes:
measure: Number of fathers reporting healthy father-child involvement and bond
timeFrame: Six months
measure: Number of fathers reporting healthy co-parenting relationship
timeFrame: Six months
measure: Number of fathers reporting development of "self as father"
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas at Austin
name: Cynthia Osborne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02750696: Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess
Official title: Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Abscess
Keywords: Acetaminophen
Analgesia
Codeine
Drug Combinations
Endodontics
Periapical abscess
Randomized Controlled Trial
Tramadol
Visual analog scale
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2016-04-25
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: The aim of this study was to compare the analgesic efficacy of two combinations of opioid and non-opioid analgesics for acute periradicular abscesses.

Methodology: This study included 24 patients who sought emergency care in a Brazilian dental school. The patients were randomly divided into two groups: Codeine/Acetaminophen - oral prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or Tramadol/Acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus acetaminophen (500 mg) on the same schedule. Patients recorded pain scores in a pain diary 6, 12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Acute Periradicular Abscess
* Age greater than 18 years
* Spontaneous pain greater than 40 mm measured in Visual Analogue Scale (moderate to severe pain).

Exclusion Criteria:

* Intake of analgesics or antibiotics within 4 hours prior to emergency surgery
* Allergy to the drugs used in this study
* Gastric ulcer, liver or kidney disease
* Uncontrolled diabetes mellitus or epilepsy
* Pregnancy or lactation

Primary outcomes:
measure: Reduction of pain scores over time.
timeFrame: 0, 6, 12, 24, 48 and 72 h after first dose administration
Secondary outcomes:
measure: Frequency of additional medication
timeFrame: Up to 72 hours
measure: Adverse reactions reported by patients
timeFrame: Up to 72 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05767996: School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
Official title: School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Familial Hyperlipidemia
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 104
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elementary school children participating in baseline biometric screening, including cholesterol; with those with elevated cholesterol receiving genetic testing to identify presence/absence of FH variant

Brief summary: Determination of FH status by genetic testing in school age children who have demonstrated elevated cholesterol on baseline screening.


Eligibility criteria: Inclusion Criteria:

Elevated cholesterol on baseline screening to use as means of identifying those with an FH variant

Exclusion Criteria:

* normal cholesterol

Primary outcomes:
measure: School-based Education and Screening Program With Lipid Screening as a Means to Identify Familial Hyperlipidemia
timeFrame: Evaluation of family members over a defined 5 year period
Secondary outcomes:
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
References: