louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01311986: Chemokine Expression in Nummular Dermatitis and Atopic Dermatitis
Official title: Chemokine Expression in Nummular Dermatitis and Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atopic Dermatitis
Nummular Eczema
Keywords: atopic dermatitis
nummular eczema
chemokines
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with atopic dermatitis

patients with nummular eczema without atopy

Brief summary: The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and their expression levels in epidermis in AD and ND patients.

Detailed description: Atopic dermatitis(AD) is a common cutaneous inflammatory disease. The pathogenesis of atopic dermatitis involves a complex interaction between atopy and environmental protein allergens which produces Th2 immune responses with IgE formation, Th2 cells dominate in lesions of atopic dermatitis, whereas Th1 and Th2 cells co-dominate in late eczematus lesions.

Nummular dermatitis(ND) is another common cutaneous inflammatory disease. The nummular patches and papules disseminated over four extremities and less over trunk . The serum levels of Th2 chemokines(CCL17, CCL22, CCL27) are elevated in AD patients. The expression levels of these chemokines in lesional epidermis are also increased. CCL18 which is derived from APC is also increased in the serum as well as lesional skin of AD patients. In contrast, there are very few reports regarding the chemokine expression profiles in ND patients. Because erosis is a remarkable exacerbating factor for ND. The investigators hypothesize that ND is a specialized contact dermatitis induced by environmental substances. It has been known, CCL17 and CXCL10 were highly expressed in lesion of allergic contant dermatitis, whereas almost no expression of these chemokines could be detected in lesions of irritant contact dermatitis.

The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and their expression levels in epidermis in AD and ND patients. The investigators hope that the results of this study will provide useful information for clinical differential diagnosis for AD and ND as well as understanding the pathogenesis of ND.

Eligibility criteria: Inclusion Criteria:

* age:20\~40, atopic dermatitis, BSA\>10%, no asthma
* age:20\~40, nummular patches\>10, no atopy

Exclusion Criteria:

* systemic immunosuppresive agents within 4 weeks
* high dose topical immunosuppresive agents within 4 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Dermatology, National Taiwan University Hospital
name: Hsien-Ching Chiu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06777186: Evaluation of Motor Skills, Balance, Dual Task, and Social Adaptation in Individuals with Autism
Official title: Evaluation of Motor Skills, Balance, Dual Task, and Social Adaptation in Individuals with Autism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism Spectrum Disorder
Motor Disorders
Social Skills
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 55
Sex: ALL
Minimum age (years): 4
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: G\*Power (version 3.1.9.4) package program was used for power analysis. Assuming that the effect size that could be obtained between the two groups would be large (f = 0.543 (EFFECT SIZE)), as a result of the power analysis, it was calculated that 80% power could be obtained at 90% confidence level (with a margin of error of 0.05) when at least 110 people were included in the study

Brief summary: The aim of our study is to evaluate motor skills balance, dual task and social adaptation skills in individuals with autism. Our study will be conducted in Bartın Lider Special Education and Rehabilitation Center after ethics committee approval. The sample number determined by power analysis will be included in the study. Socio-demographic characteristics (age, height, body weight, body mass index, education level, exercise and smoking habits, etc.) of the individuals who voluntarily participated in the study will be obtained. The individuals participating in the study will be divided into two groups as individuals with normal motor development and individuals with autism spectrum disorder and the same assessment scales will be used. These assessment scales are TUG, 10 meter walking test, Vineland Adaptive Adaptation Scale, Bruininks-Oseretsky Motor Competence Test. According to the evaluation results, motor skills, functional balance, dual task and social adaptation skills of individuals with autism will be compared with individuals with normal motor development.


Eligibility criteria: Inclusion Criteria:

* Being diagnosed with ASD by a physician
* Children are receiving education in a special education and rehabilitation center
* No vision problems
* Ability to receive and execute commands
* No cognitive problems
* No walking problems

Exclusion Criteria:

* Individuals with concomitant secondary diseases
* Individuals who have undergone surgery in the last six months

Primary outcomes:
measure: 10 meter walk test
timeFrame: At enrollment
Secondary outcomes:
measure: Functional Balance
timeFrame: At enrollment
measure: Social Adaptation Assessment
timeFrame: At enrollment
measure: Motor skills and proficiency
timeFrame: At enrollment
Other outcomes:
Locations:
city: Kirikkale
country: Turkey
facility: Kırıkkale University
Study officials:
References:
Clinical trial NCT01395186: Varicocelectomy To Treat Pain, Predictors Of Success
Official title: Varicocelectomy To Treat Pain, Predictors Of Success : A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: varicocele
pain
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 145
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: there are many studies studying the effectiveness of surgical treatment in patients treated for infertility, but only a few reporting the results of varicocelectomy done for pain. This study attempted to examine the success rate of varicocele ligation when performed for the treatment of pain and to evaluate all the predictor factors that may affect the pain resolve

Detailed description: varicocelectomy for patients complaining of pain and studying the effectiveness and all predictors that can affect the degree of response

Eligibility criteria: Inclusion Criteria:

* painful varicocele after failure of medical therapy

Exclusion Criteria:

* responders to medical therapy

Primary outcomes:
measure: pain resolve after varicocelectomy
timeFrame: 3 months foloow up
Secondary outcomes:
measure: semen parameters
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: ramadan ellithy, md
role: STUDY_CHAIR
References:
Clinical trial NCT05844163: Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)
Official title: Treatment Strategies for Unruptured Intracranial Aneurysms in the Chinese Population China Treatment Trial for Unruptured Intracranial Aneurysm (ChTUIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unruptured Intracranial Aneurysm
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: First Affiliated Hospital of Fujian Medical University
name: Shanxi Provincial People's Hospital
First posted: 2023-05-06
Enrollment: 31595
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with unruptured intracranial aneurysm

Brief summary: The goal of this prospective observational cohort study is to learn about treatment strategies for unruptured intracranial aneurysms in the Chinese population. The main questions it aims to answer are:

* To establish a cohort of patients with intracranial unruptured aneurysm and explore the optimal clinical treatment strategy.
* To establish clinical management path for patients with unruptured intracranial aneurysm.

According to the treatment of all patients with unruptured intracranial aneurysm, they were divided into the following groups: 1. Conservative treatment group; 2. Intracranial aneurysm clipping group; 3. Coil embolization or stent-assisted coil embolization group; 4. Flow diversion group.


Eligibility criteria: Inclusion Criteria:

A. age \> 18 years. B. at least one intracranial aneurysm needs to be treated by craniotomy, endovascular treatment or combined surgery.

C. patients' consent were obtained.

Exclusion Criteria:

1. Ruptured intracranial aneurysms, accompanied by subarachnoid hemorrhage or cerebral hemorrhage ;
2. Traumatic, infectious and atrial myxoma-associated intracranial aneurysms ;
3. Combined with cerebrovascular malformations;
4. Combined with brain tumors or malignant tumors in other parts ;
5. Combined with systemic connective tissue disease and systemic rheumatic disease ;
6. Due to other diseases, or poor general condition, the expected survival time is not more than 12 months ;
7. During pregnancy and perinatal period.

Primary outcomes:
measure: Primary Outcome
timeFrame: 2 years
Secondary outcomes:
measure: MACCE events
timeFrame: 1 years
measure: cardiovascular/cerebrovascular events
timeFrame: 2 years
measure: Cost
timeFrame: 2 years
measure: Aneurysm-related bleeding events
timeFrame: 2 years
measure: Mortality associated with intracranial aneurysms
timeFrame: 2 years
measure: All-cause mortality
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Capital Medical University Affiliated Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Wang shuo, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05568563: Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey
Official title: Comparison of Effectiveness of Pre-cooling With Ethyl Chloride Versus Honey in Alleviating Intra-oral Injection Pain in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irreversible Pulpitis
Lead sponsor: Altamash Institute of Dental Medicine
Sponsor class: OTHER
First posted: 2022-10-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing Pre-cooling with Ethyl Chloride versus Honey in Alleviating Intra-oral injection pain in Adult patients


Eligibility criteria: Inclusion Criteria:

* No medical history
* Patients suffering from Symptomatic Irreversible Pulpitis requiring buccal infiltration

Exclusion Criteria:

* Patients having any medical conditions considered to affect patient safety or the quality of the study
* if they had any known hypersensitivity to local anaesthetics of amide type or any of the other contents in the substance used

Primary outcomes:
measure: To alleviate dental injection pain
timeFrame: immediately after completion of administration of oral local anesthetic infiltration within 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Hira Danish
state: Sindh
Study officials:
References:
Clinical trial NCT01489163: Lifestyle Intervention Program for Women With Gestational Diabetes or Gestational Impaired Glucose Tolerance
Official title: Translational Diabetes Prevention in GDM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Gestational Diabetes
Weight Loss
Physical Activity
Pregnancy
Postpartum
Intervention
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2011-12-09
Enrollment: 352
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to implement and evaluate a lifestyle program designed to help women who have high glucose levels during pregnancy make healthful diet and physical activity changes to lose weight. Eligible women will be randomly assigned to life-style intervention or usual medical care.


Eligibility criteria: Inclusion Criteria:

* Women receiving prenatal care at Kaiser Permanente Santa Clara, Santa Teresa, Hayward, and Oakland
* Pregnancy complicated by high glucose levels starting November 2011

Exclusion Criteria:

* Recognized DM prior to pregnancy
* Uncontrolled hypertension during pregnancy
* Severe active thyroid disease during pregnancy
* Severe diseases of the cardio-pulmonary system
* Diagnosis of a severe psychiatric disorder
* Diagnosis of cancer
* Conditions that lead to diet changes
* Addiction to alcohol or illegal drugs
* Current corticosteroid medicine use

Primary outcomes:
measure: postpartum body weight
timeFrame: through 24 months postpartum
Secondary outcomes:
measure: the proportion of women who reach body weight goals
timeFrame: through 24 months postpartum
measure: percent of calories from fat
timeFrame: through 24 months postpartum
measure: time spent in physical activity (PA) by intensity
timeFrame: through 24 months postpartum
measure: postpartum glycemia
timeFrame: through 24 months postpartum
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Division of Research Northern California
state: California
Study officials:
affiliation: Kaiser Permanente Division of Research
name: Assiamira Ferrara, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03466463: Gene Therapy for Severe Crigler Najjar Syndrome
Official title: A Phase I/II, Open Label, Study to Evaluate Safety and Efficacy of an Intravenous Injection of GNT0003 (AAV Vector Expressing the UGT1A1 Transgene) in Patients With Severe Crigler-Najjar Syndrome Requiring Phototherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crigler-Najjar Syndrome
Keywords: Crigler-Najjar
Adeno Associated Virus
Lead sponsor: Genethon
Sponsor class: OTHER
First posted: 2018-03-15
Enrollment: 17
Sex: ALL
Minimum age (years): 9
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: This is a Phase 1/2, multinational, open-label, study to evaluate the safety and efficacy of an intravenous infusion of GNT0003 in patients with Crigler-Najjar aged ≥10 years and requiring phototherapy. Patients will received a single administration of GNT0003 and will be followed for safety and efficacy of approximately 60 months (5 years):

* a follow-up of approximately 12 months (48 weeks)
* a long term follow-up of approximately 48 months (4 years), in order to be in line with the latest EMEA Guideline on follow-up of patients administered with gene therapy medicinal products, released on 22 Oct.2009 by the Committee for medicinal products for human use.


Eligibility criteria: Inclusion Criteria:

* Patients with severe Crigler-Najjar syndrome resulting from a molecular confirmation of mutations in the UGT1A1 gene and requiring phototherapy
* Male or female at least 9 years at the date of signature of informed consent
* Patient able to give informed assent and/or consent in writing

Exclusion Criteria:

* Patients who underwent liver transplantation
* Patients with chronic hepatitis B or C
* Patients infected with Human immunodeficiency virus (HIV)
* Patients with significant underlying liver disease
* Patients with significant encephalopathy
* Participation in any other investigational trial during this trial
* Patients unable or unwilling to comply with the protocol requirements

Primary outcomes:
measure: Proportion of patients having received the selected dose of GNT0003 with serum bilirubin ≤ 300µmol/L within 48 meeks after GNT0003 administration and without phototherapy from week 16
timeFrame: 48 weeks
measure: Incidence of Treatment Emergent Adverse Events or Treatement Serious Adverse Events
timeFrame: 48 weeks
Secondary outcomes:
measure: Change in Health-related quality of Life for Adults from Baseline to Week 48 after GNT0003 administration
timeFrame: 48 weeks
measure: Change in Health-related quality of Life for Children from Baseline to Week 48 after GNT0003 administration
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hopital Antoine BECLERE
city: Bergame
country: Italy
facility: ASST Papa Giovanni XXIII
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II
city: Amsterdam
country: Netherlands
facility: AMC
Study officials:
affiliation: Hopital Antoine Beclere
name: LABRUNE Philippe, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04949763: Reliability and Validity of the ISNCSCI in Patients With Non-traumatic Spinal Cord Lesions
Official title: Reliability and Validity of the International Standards for Neurological Classification of Spinal Cord Injury in Patients With Non-traumatic Spinal Cord Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Keywords: non traumatic spinal cord injury
ISNCSCI
inter-rater reliability
rehabilitation
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with non traumatic spinal cord lesions

Brief summary: Aim of the study is to assess the psychometric properties of the International Standards for Neurological Classification of Spinal Cord Injury in subjects with non traumatic lesions.

Detailed description: All patients with non-traumatic SCI consecutively admitted to three Italian SCI centers (IRCCS Fondazione Santa Lucia, Montecatone Rehabilitation Hospital and Istituti Clinici Scientifici Maugeri IRCCS of Pavia) between January 1st 2017 and June 30th 2020 have been prospectively enrolled in the study.

Eligibility criteria: Inclusion Criteria:

* having a non-traumatic SCI
* acute / subacute phase
* any level and severity (ASIA Impairment Scale) of injury
* having a cognitive status that allows collaboration in the exam.

Exclusion Criteria:

* presence of dementia or cognitive decline;
* having a pathology of the peripheral nervous system that may affect the evaluation of ISNCSCI;
* having a multiple sclerosis

Primary outcomes:
measure: Interanational Standards for Neurological Classification of Spinal Cord Injury
timeFrame: 1 year
Secondary outcomes:
measure: Spinal Cord Independence Maesure
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: Rupp R, Biering-Sorensen F, Burns SP, Graves DE, Guest J, Jones L, Read MS, Rodriguez GM, Schuld C, Tansey-Md KE, Walden K, Kirshblum S. International Standards for Neurological Classification of Spinal Cord Injury: Revised 2019. Top Spinal Cord Inj Rehabil. 2021 Spring;27(2):1-22. doi: 10.46292/sci2702-1. No abstract available.
Clinical trial NCT03833063: Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
Official title: Glabellar Botulinum Toxin Injections for the Treatment of Geriatric Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Major Depressive Disorder
Major Depressive Episode
Treatment Resistant Depression
Keywords: botulinumtoxin
botox
depression
geriatric depression
depression in older adults
depression in the elderly
old age depression
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2019-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: placebo controlled, randomized, cross-over
Primary purpose: TREATMENT

Brief summary: The effectiveness of glabellar injection of botulinum toxin type A (BTA) in treating depression has not yet been investigated in elderly patients. The study aims in addressing the question if glabellar injection of BTA is effective in treating geriatric depression.

Detailed description: Feedback from facial expressions is known to influence emotional experience. Treatment of muscles involved in facial expression of sadness, anger or anxiety with botulinumtoxin showed a quick, strong and sustained improvement in the symptoms of depression. As considerable proportion of patients do not sufficiently respond to existing treatment options. Especially in the elderly current treatments show limited response or are associated with side effects. Injections with BTA are considered as a very safe treatment without lasting side effects. The aim of the study is to investigate effectiveness of BTA in treating major depression in the elderly in a cross-over designed, placebo-controlled manner.

Eligibility criteria: Inclusion criteria: Clinically relevant depressive symptoms ( defined as MADRS \> 12)

Exclusion criteria: cognitive deficits that impair the participant´s ability to provide written informed consent severe depression MADRS \>34 suicidality treatment with more than 3 psychotropic medications recent changes (4 weeks) in current psychotropic medication previous treatment with study drug active substance abuse bipolar disorder schizophrenia unstable medical condition usage of warfarin or NOAC bleeding disorder known hypersensitivity to study drog or any of the excipients of the formulation myasthenia gravis or Eaton Lambert syndrome presence of infection at the proposed injection sites

Primary outcomes:
measure: Severity og depressive symptoms, response to treatment
timeFrame: 16 weeks
Secondary outcomes:
measure: remission
timeFrame: 16 weeks
measure: severity of depressive symptoms, self-rated Geriatric Depression Scale (GDS)
timeFrame: 16 weeks
measure: quality of life, as assessed with QOL-AD
timeFrame: 16 weeks
measure: safety/tolerability
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
References: