louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06489067: Study of the Thyroid Function and Echostructural Morphology in Patients Affected With Rasopathies (ECORAS2023)
Official title: Study of the Thyroid Function and Echostructural Morphology in Patients Affected With Rasopathies. An Italian Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: RASopathy
Lead sponsor: University of Bari Aldo Moro
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 115
Sex: ALL
Minimum age (years): 3
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients with genetically confirmed RASopathy

Brief summary: The study aims to evaluate the prevalence of thyroid disease, particularly with autoimmune pathogenesis (isolated hyperthyrotropinemia, hyperthyroidism, hypothyroidism, thyroid nodules) and/or morphostructural abnormalities of the thyroid gland in patients with RASopathy genetically confirmed by NGS technique (analysis of the genes: BRAF, CBL, HRAS, KRAS, LZTR1, MAP2K1, MAP2K2, MRAS, NRAS, PPP1CB, PTPN11, RAF1, RIT1, RRAS2, SHOC2, SOS1, SOS2) and to compare the data obtained in our sample with those of the general population.

The secondary aim of the study is to evaluate the association between vitamin D deficiency and/or other abnormalities of bone metabolism and thyroid disease and/or morphostructural anomalies of the thyroid gland in patients with RASopathy.

Detailed description: All patients will undergo blood sampling aimed at studying thyroid function and autoimmunity (TSH, fT3, fT4, anti-TPO, anti-TG, anti-TSH receptor antibodies) and biomarkers of bone metabolism (calcium, phosphorus, ALP isoenzyme bone, PTH, osteocalcin, vitamin D) and a systematic color Doppler ultrasound examination of the thyroid gland in order to evaluate dimensions, echostructure and echogenicity of the thyroid parenchyma, presence of nodular lesions, vascularization and laterocervical lymphadenopathy.

Eligibility criteria: Inclusion Criteria:

* Genetically confirmed RASopathy
* Age 3-25 years

Exclusion Criteria:

* Previous radiotherapy treatments, known exposure to ionizing radiation
* Iodine deficiency
* Use of iodine-based compounds or drugs that interfere with thyroid function
* Congenital hypothyroidism/hyperthyroidism
* Severe obesity with metabolic complications

Primary outcomes:
measure: Number of patients with RASopathies presenting with thyroid function and ultrasound abnormalities compared to the general population (observational study)
timeFrame: 6 months
Secondary outcomes:
measure: Number of patients with RASopathies presenting with bone disease
timeFrame: 6 months
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University of Bari
Study officials:
affiliation: University of Bari
name: MARIA FELICIA FAIENZA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00750867: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Official title: Treatment of Multiple System Atrophy Using Intravenous Immunoglobulins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple System Atrophy
Keywords: multiple system atrophy, MSA,
intravenous immunoglobulin, IVIg
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2008-09-11
Enrollment: 9
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: Multiple System Atrophy (MSA) is a progressive sporadic neurodegenerative disorder leading to widespread loss of brain cells that results in parkinsonian, cerebellar and autonomic dysfunction. The cause of the MSA remains unclear. Available treatment is symptomatic only and does not alter the course of disease.

Although the cause of MSA remains unclear, there is evidence of presence of common neuroinflammatory mechanisms in the MSA brains including activation of microglia and production of toxic cytokines. This research protocol is based on hypothesis that the MSA progression can be altered by blocking the neuroinflammatory activity.

This protocol includes administration of intravenous immunoglobulin (IVIg). IVIg contains antibodies derived from human plasma which can block the inflammatory responses in the brain that can lead to loss of brain cells.


Eligibility criteria: Inclusion Criteria:

1. Male or female older than 17 years.
2. Clinical diagnosis of probable multiple system atrophy
3. Provide written informed consent to participate in the study
4. Understand that they may withdraw their consent at any time

Exclusion Criteria:

1. Women who are pregnant or lactating
2. In the investigator's opinion, have any other significant systemic, hepatic, cardiac or renal illness.
3. In the investigator's opinion, the subjects are significantly dehydrated, as determined by clinical evaluation including measurement of skin turgor, blood urea nitrogen and creatinine values.

Primary outcomes:
measure: Number of Adverse Events up to Six Months Post-treatment
timeFrame: Monthly, up to 8 months (including the screening visit and the final visit)
Secondary outcomes:
measure: Preliminary Efficacy of IVIg for Treatment of MSA.
timeFrame: Monthly, up to 8 months (including the screening visit and the final visit)
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Peter Novak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Novak P, Williams A, Ravin P, Zurkiya O, Abduljalil A, Novak V. Treatment of multiple system atrophy using intravenous immunoglobulin. BMC Neurol. 2012 Nov 1;12:131. doi: 10.1186/1471-2377-12-131.
Clinical trial NCT02695667: Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS)
Official title: Quantitative Genioglossal Muscle Strength in Obstructive Sleep Apnea (OSAS) Defined in the Clinical Spectrum of Subjects With Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Sleep Apnea
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2016-03-01
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This initial pilot investigation will screen up to 70 individuals to obtain the necessary enrollment of 22 subjects per group from Stage Three: CPAP Referral OSAS; and paired normal control subjects

Brief summary: Quantitative Genioglossal muscle strength in Obstructive Sleep Apnea (OSAS) defined in the clinical spectrum of subjects with Snoring Disturbance, Oral Appliance Therapy Responsive, and CPAP Responsive

Detailed description: To describe by statistical analysis the normal distribution domain of genioglossus muscle strength in each of the four clinical stages of Sleep Apnea; and, by regression analysis, to explore the possibility of an inverse relationship between decreasing genioglossus strength and progression of the clinical stages of OSAS.

1.3. To test the hypothesis that a "subpopulation of subject" exists within the clinical spectrum of OSAS, in whom decreasing strength of the genioglossus muscle may represent a common element in spite of differing possible pathophysiologic pathways leading to Obstructive Sleep Apnea in man. 1.4. The major hypothesis of this proposal is thus that "Genioglossal Strength is inversely correlated with Obstructive Sleep Apnea Pathology."

Eligibility criteria: Inclusion Criteria:

* Age 20-40 years inclusive BMI 18-25 Non-smoking history and no current use for a minimum of 6 months No smokeless tobacco products (including e-cigarettes) for a minimum of 6 months No sleep snoring reported by subject and by bedroom "companion" Self-described as active/athletic (i.e. regular hikes, walks, jogging, running, active Sports, such as volleyball, soccer, etc.) Self-described as healthy, with no known disease or recent illness Self-completed Epworth Sleepiness Scale of \<6 (Johns, MW, A new method for Measuring daytime sleepiness: the Epworth Sleepiness Scale; SLEEP 14:450-5, 1991). Physical Examination Mallampati Score of Class 1 (Nuckton, TJ, et al: Physical

Examination: Mallampati Score as an Independent Predictor of OSAS; SLEEP 29:

903-908, 2006).

Exclusion Criteria:

-

Primary outcomes:
measure: Genioglossal Strength
timeFrame: single clinic visit
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Clinical Translational Science Center
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Philip Eaton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06711367: Evaluation of Custom-designed Dental Storybook on the Dental Anxiety and Behavior of Children
Official title: Comparative Evaluation of the Effectiveness of Custom-designed Dental Storybook Vs Tell Show Do on the Dental Anxiety and Behavior of Children: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Child Behavior
Dental Anxiety
Keywords: dental storybook
tell show do
dental anxiety
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 48
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Conventional behavior management techniques, namely: verbal communication and tell-show-do were used in the operatory for the participating children (Group A). The children allocated in intervention group (Group B) received a costume-designed storybook explaining the diagnosis and procedures of occlusal composite restoration


Eligibility criteria: Inclusion Criteria:

* • Healthy children and children/parents can read and understand Arabic.

  * The child needs an occlusal composite restoration.

Exclusion Criteria:

* Children with special needs; children with a complete audiovisual impairment; children with
* Learning difficulties or mental retardation.
* Children who are not Arabic speakers.

Primary outcomes:
measure: Child anxiety
timeFrame: through study completion, an average of four months
Secondary outcomes:
measure: Pulse rate
timeFrame: through study completion, an average of four months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October University of Modern Sciences and Arts
Study officials:
References:
Clinical trial NCT03630367: Effects of L-Carnitine Supplementation on Respiratory Distress Syndrome
Official title: Effects of Adding L-Carnitine With Dexamethasone on Respiratory Distress Syndrome Development in Preterm Infants
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Premature Birth
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study was to investigate the efficacy of L-carnitine therapy on the occurrence and prognosis of respiratory distress syndrome


Eligibility criteria: Inclusion Criteria:

* Pregnant women between 30-37 weeks
* singleton pregnancy

Exclusion Criteria:

* congenital malformed fetus
* Extreme premature

Primary outcomes:
measure: the mean difference in the Apgar score after birth
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT01030367: Pilot Study of Organic Nitrates on Endothelial Function in CAD Patients
Official title: Pilot Study of Organic Nitrates on Endothelial Progenitor Cells and Endothelial Function in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Lead sponsor: Julius-Maximilians University
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Organic nitrates increase levels of circulating endothelial progenitor cells (Thum et al., Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54). Here, we want to test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function.

Detailed description: In this pilot study we test the effects of two different organic nitrates (PETN, ISDN) on number and function of endothelial progenitor cells and endothelial function. These parameters will be measured before and after 14d of treatment.

Eligibility criteria: Inclusion Criteria:

* Coronary artery disease, 2- or 3-vessel disease

Exclusion Criteria:

* Acute myocardial infarction, acute heart failure, cancer, acute infections

Primary outcomes:
measure: Endothelial function Number of endothelial progenitor cells Function of endothelial progenitor cells
timeFrame: Baseline and after 14d
Secondary outcomes:
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: Julius-Maximilians University
state: Bavaria
Study officials:
affiliation: University of Würzburg
name: Thomas Thum, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thum T, Fraccarollo D, Thum S, Schultheiss M, Daiber A, Wenzel P, Munzel T, Ertl G, Bauersachs J. Differential effects of organic nitrates on endothelial progenitor cells are determined by oxidative stress. Arterioscler Thromb Vasc Biol. 2007 Apr;27(4):748-54. doi: 10.1161/01.ATV.0000258787.18982.73. Epub 2007 Jan 25.
Clinical trial NCT00226967: Stress, Diurnal Cortisol, and Breast Cancer Survival
Official title: Stress, Diurnal Cortisol, and Breast Cancer Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2005-09-27
Enrollment: 115
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with recurrent or metastatic breast cancer

Brief summary: The purpose of this study is to learn about the effects of stress on hormones, the relationship between these hormones and cancer progression.

Detailed description: The purpose of this study is to investigate stress and tonic activation of diurnal cortisol in aging metastatic breast cancer patients; feedback inhibition \& activation of cortisol; and stress-induced phasic activation of cortisol.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of recurrent or metastatic breast cancer.
2. Karnofsky of 70% or greater.
3. Proficient enough in English to be able to take questionnaires and participate in the required tasks.
4. Living within the Greater Bay Area.
5. Age 35 or older .

Exclusion Criteria:

1. Positive supraclavicular lymph nodes as the only metastatic lesion at the time of initial diagnosis.
2. Active cancers within the past 10 years other than breast cancer, basal cell or squamous cell carcinomas of the skin, or in situ cancer of the cervix.
3. Any other serious medical condition that will effect short term survival
4. History of major psychiatric illness for which patient was hospitalized or medicated, with the exception of depression or anxiety
5. A diagnosis of diabetes.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: David Spiegel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02466867: An Open Label Pharmacokinetic Study of Naftin for Tinea Corporis
Official title: An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftin® (Naftifine Hydrochloride) Cream, 2% in Pediatric Subjects With Tinea Corporis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinea Corporis
Keywords: Ringworm
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 27
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an open label, multi-center, multi-application pharmacokinetic study in pediatric subjects with tinea corporis.


Eligibility criteria: Inclusion Criteria:

* Male or females 2 to 11 years, 11 months of any race. Females of child producing age (started menarche) must have a negative urine pregnancy test.
* Presence of tinea corporis characterized by clinical evidence of a tinea infection at multiple sites covering a total of at least 1% body surface area.
* KOH positive and culture positive baseline skin scrapings obtained from the site most severely affected of the overall severity.
* Subjects must be in good health and free from clinically significant disease that might interfere with the study evaluations.

Exclusion Criteria:

* Tinea infection of the scalp, face, groin, and/or feet.
* A life-threatening condition (ex. autoimmune deficiency syndrome, cancer) within the last 6 months
* Subject with abnormal findings-physically or laboratory- that considered by the investigator to be clinically important and indicative of conditions that might complicate interpretation of study results.
* Subjects with a known hypersensitivity or other contradictions to study medications or their components.

Primary outcomes:
measure: To quantify the plasma concentration of single and multiple dose of naftifine hydrochloride cream, 2% in pediatric subjects with tinea corporis
timeFrame: 2 weeks
Secondary outcomes:
measure: Evaluate plasma PK single and multiple dose PK variables
timeFrame: 2 weeks
measure: Evaluate trough plasma PK concentration
timeFrame: 2 weeks
measure: Evaluate urine PK single and multiple dose variables
timeFrame: 2 weeks
Other outcomes:
Locations:
city: College Station
country: United States
facility: Merz Investigative Site#001261
state: Texas
city: Santo Domingo
country: Dominican Republic
facility: Merz Investigative Site#180001
city: San Pedro Sula
country: Honduras
facility: Merz Investigative Site #504001
Study officials:
affiliation: Merz North America, Inc.
name: Alan B. Fleischer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01043367: Deprexil in Subjects With Signs and Symptoms of Depression
Official title: Efficacy of Deprexil Administration in Subjects With Signs and Symptoms of Depression.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depression
Keywords: Depression
Dietary supplement
Deprexil
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2010-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of DEPREXIL administration in combination with relaxation psychotherapy in the treatment of patients with signs and symptoms of depression. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of persons to be recruited and randomized for the study is 200.


Eligibility criteria: Inclusion Criteria:

* Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration.
* Signed informed consent

Exclusion Criteria:

* Severe symptoms and signs of depression or Suicide proneness.
* Pregnancy or breastfeeding
* Receiving other experimental drug
* Use of anti-depressive medication within 15 days

Primary outcomes:
measure: Functional capabilities at week 24 (end of the treatment)
timeFrame: 24 weeks
measure: Social capabilities at week 24 (end of the treatment)
timeFrame: 24 weeks
measure: Psycho-affective capabilities at week 24 (end of the treatment)
timeFrame: 24 weeks
measure: Behavioral capabilities at week 24 (end of the treatment)
timeFrame: 24 weeks
Secondary outcomes:
measure: Tolerability to Deprexil at week 24 (end of the treatment)
timeFrame: 24 weeks
measure: Symptoms of depression at week 24 (end of the treatment)
timeFrame: 24 weeks
measure: Signs of depression at week 24 (end of the treatment)
timeFrame: 24 weeks
measure: Clinical symptoms of baseline disease at 24 weeks (end of the treatment)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Heroes del Moncada" Polyclinic
state: Havana
Study officials:
affiliation: "Heroes del Moncada" Polyclinic
name: Maria de la Concepción Valdivia Alarcón, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06641167: Interest of Soft Point Anesthesia in Association With Locoregional Anesthesia in Arthroscopic Shoulder Surgery
Official title: Interest of Soft Point Anesthesia in Association With Locoregional Anesthesia in Arthroscopic Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anesthesia, Local
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population of patients undergoing shoulder surgery by arthroscopic approach under locoregional anesthesia combining an interscalene block and a superficial cervical plexus block (supraclavicular nerve)

Brief summary: This is a prospective, single-center, observational study. The inclusion period is set at 12 months.


Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years or older
* Patient informed about the study and who has not opposed the use of their personal medical data
* Patient scheduled for arthroscopic shoulder surgery

Exclusion Criteria:

* Allergy to local anesthetics or epinephrine
* Contraindications to Interscalene Block (e.g., respiratory disease, pneumothorax, pneumonectomy, phrenic or recurrent laryngeal nerve paralysis)
* Coagulation disorder
* Patients unable to understand the study information and objectives: dementia, psychosis, consciousness disorders, non-French-speaking patients
* Patients under legal protection measures (guardianship, curatorship) or deprived of liberty by judicial or administrative decision

Primary outcomes:
measure: Soft point position
timeFrame: Hour 24
Secondary outcomes:
measure: Incision pain
timeFrame: Hour 24
measure: Postoperative pain
timeFrame: Hour 2
measure: Postoperative pain
timeFrame: Hour 6
measure: Postoperative pain
timeFrame: Hour 24
measure: Sedative medication
timeFrame: Hour 24
measure: Analgesic consumption
timeFrame: Hour 24
measure: Intervention duration
timeFrame: Hour 24
measure: Stay in the PACU duration
timeFrame: Hour 24
measure: Adverse events
timeFrame: Hour 24
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital privé Claude Galien
Study officials:
References: