louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01950897: Muscle Tissue Bank for Muscular Dystrophy
Official title: Establishment of Phenotypic Profiles of Muscular Dystrophies for Understanding Disease Progression, Diagnosis and Development of New Therapies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscular Dystrophies
Muscular Dystrophy
Keywords: muscular dystrophies
muscular dystrophy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to the Carolinas Medical Center (CMC) Department of Neurology who meet study criteria.

Brief summary: This protocol proposes to establish gene expression profiles of muscular dystrophies for correct diagnosis and for development of experimental therapies for these diseases.

Detailed description: Muscular dystrophies are caused by mutations in more than 30 genes, some of them remaining to be identified. Phenotypically, it is known that one specific mutation can affect the expression of several other proteins causing difficulty in diagnosis. Correct genotyping is essential for diagnosis, prognosis and treatment, and relies on a complexed analysis of muscle tissues for phenotype profiles. Our research aims to understand how different gene mutations affect expression of other genes via muscle biopsy samples and establishment of phenotypic profiles for correct diagnosis of individual patients. Establishment of such information will be critical for understanding the progression of different muscular dystrophies and to devise new experimental therapies. This research will also provide vital clues for finding new genes involved in the disease process. Muscle samples may also be used to establish cell cultures for testing drugs and new therapies relevant to the treatment of the muscular dystrophies.

Eligibility criteria: Inclusion Criteria:

* subjects with or without muscular dystrophy who will be undergoing a diagnostic or therapeutic procedure that involves the removal of a sample of skeletal muscle tissue.
* subjects with or without muscular dystrophy who have had a previous skeletal muscle biopsy performed and where a portion of the muscle sample remains in medical storage are also eligible for this study.

Exclusion Criteria:

* Under age 6

Primary outcomes:
measure: Immunohistochemistry for protein expression profiling of skeletal muscle tissue; initial analysis will be qualitative (positive or negative) or semi-quantitative (strong, moderate, weak or negative)
timeFrame: Data will be analyzed at one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Carolinas Medical Center - Dept of Neurology
state: North Carolina
Study officials:
affiliation: Medical Director, Carolinas Neuromuscular/ALS-MDA Center, CMC
name: Benjamin R Brooks, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00059397: Hepatitis C: Grading and Staging by MR
Official title: Hepatitis C: Grading and Staging by MR
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis
Keywords: Hepatitis C
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2003-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: To compare MR imaging findings with biopsy for grading and staging early hepatitis C.


Eligibility criteria: Referral only

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06485297: Effect Tunnel in Oral Medicine
Official title: Evaluation of the Tunnel Effect Within a French Population of Dental Surgeons: a Pilot Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological
Keywords: tunnel effect
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6th year students and interns + CHU and liberal practitioners

Brief summary: Evaluate whether there are differences in knowledge between practitioners and students regarding the tunnel effect, to validate the benefit of teaching it in oral medicine. Main objective: to evaluate the state of knowledge relating to the tunnel effect concerning the performance of a surgical procedure, of a cohort of odontologists of different professional levels. Secondary objectives: evaluate the nature of the means they propose in order to counter the effects of this cognitive bias.


Eligibility criteria: Inclusion Criteria: - Externs in the 6th year, interns and teachers working within the Riquier Institute of Oral Medicine at Nice University Hospital, and private dental surgeons.

Exclusion Criteria: - dental student under 6th year

Primary outcomes:
measure: Evaluation of the state of knowledge relating to the tunnel effect concerning the performance of a surgical procedure, of a cohort of odontologists of different professional levels.
timeFrame: At the inclusion
Secondary outcomes:
measure: Evaluation of the nature of the means proposed to combat the tunnel effect
timeFrame: At the inclusion
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
References:
Clinical trial NCT05631197: Biomimetic Hydroxyapatite in Pediatric Patients With Asthma and/or Allergic Rhinitis
Official title: Biomimetic Hydroxyapatite vs Fluoride for the Domiciliary Oral Hygiene of Pediatric Patients With Asthma and/or Allergic Rhinitis: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Periodontal Diseases
Keywords: Dental hygiene
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the incidence of dental caries and the level of demineralization in pediatric patients with asthma and/or allergic rhinitis.

Patients will conduct professional oral hygiene at the baseline. The following clinical indexes will be assessed: BEWE Index, Plaque Index, Bleeding Score, Schiff Air Index. Then, patients will be randomly divided into two groups:

* Trial group: domiciliary use of Biorepair Total Protection Plus + desensitizing enamel-repair shock treatment twice a day
* Control group: domiciliary use of Elmex Caries Protection twice a day

The clinical indexes will be assessed again after 1 month (T1), after 3 (T2) and 6 months (T3).


Eligibility criteria: Inclusion Criteria:

* pediatric patients aged between 6-14 years
* diagnosis of allergic rhinitis and asthma
* therapy with salmeterol/fluticasone propionate
* diffused enamel demineralizations of deciduous and permanent teeth

Exclusion Criteria:

* low cooperation according to grades 3 and 4 of Frankl behavioral scale
* nonadherence to the study protocol checked by parents
* other systemic diseases.

Primary outcomes:
measure: Change of the BEWE Index - Basic Erosive Wear Examination (Barlet et al.2008)
timeFrame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
measure: Change in Shiff Air Index - Dental sensitivity test
timeFrame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
measure: Change in BoP - Bleeding on Probing
timeFrame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
measure: Change in PI - Plaque Index (Silness and Löe, 1964)
timeFrame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
measure: Change in salivary pH
timeFrame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
measure: Change in SI - Susceptibility Index
timeFrame: Baseline (T0), 1 month (T1), 3 months (T2), 6 months (T3)
Secondary outcomes:
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Unit of Dental Hygiene - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Paediatrics - University of Pavia
state: Lombardy
Study officials:
affiliation: University of Pavia
name: Andrea Scribante, DDS, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487097: The Effect of Antioxidants on the Immune Response and Wound Healing in Critically Ill Patients
Official title: Effect of EPA, GLA and Antioxidants on the Immune Response - Cellular and Molecular Mechanisms of Wound Healing in Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Sores
Intensive Care
Keywords: intensive care
critically ill
fish oil
pressure sores
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2007-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether the addition of omega-3 and antioxidants to nutritional support in critically ill patients in the intensive care unit influences the immune and anti-inflammatory systems and so improves wound healing.

Detailed description: A prospective randomized study to include 40 consecutive patients admitted to the general intensive care unit. The control group will receive nutritional support composed of a standard formula. The study group will receive nutritional support enriched with fish oil and anti-oxidants. The following variables will be assessed in all patients: demographics, severity of illness, assessment of bed sores. Blood tests will also be taken for the following: CD 8, CD 14, CD 18, CD 11a, CD49c, CD 49d. In addition, blood samples will be collected for TNF, IL-1b, IL-6, IL-8, and levels of C-reactive protein. Metabolic parameters such as resting energy expenditure, BMI, albumin, prealbumin, levels of zinc, relationship between omega 3 and omega 6. Theses test will be performed at time of ICU admission, days 7, 14 and 28 after admission.

The outcome: improved repair of pressure sores, together with improvement in objective parameters of immunity and inflammation.

Eligibility criteria: Inclusion Criteria:

* Critically ill patients in intensive care unit
* Grade 2 pressure sores

Exclusion Criteria:

* Immunosuppression with steroids or other agents
* Active bleeding
* Head trauma

Primary outcomes:
measure: Improvement of wound healing of pressure sores
timeFrame: within 28 days
Secondary outcomes:
measure: Improvement in parameters of immunity and inflammation
timeFrame: Within 28 days
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical center
Study officials:
affiliation: Rabin Medical Center, Beilison Hospital, Israel
name: Pierre Singer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Theilla M, Schwartz B, Cohen J, Shapiro H, Anbar R, Singer P. Impact of a nutritional formula enriched in fish oil and micronutrients on pressure ulcers in critical care patients. Am J Crit Care. 2012 Jul;21(4):e102-9. doi: 10.4037/ajcc2012187.
Clinical trial NCT00938197: A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
Official title: An Open-label, Multiple-dosing, and Crossover Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Essential Hypertension
Keywords: Fimasartan
Drug interaction
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 34
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER

Brief summary: To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers


Eligibility criteria: Inclusion Criteria:

* age: 20 - 40 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and amlodipine
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism
* history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study

Primary outcomes:
measure: AUCss, Cmax,ss, Tmax,ss, CLss/F
timeFrame: Part A: 0, 0.5, 1, 1.5, 2, 2.5 3, 4, 6, 8, 12, 24 hours at 7 day and 21 day Part B: 0, 1, 3, 4, 5, 6, 7, 8, 9, 11, 13, 15, 24 hours at 10 day and 34 day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Yi S, Kim TE, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Pharmacokinetic interaction of fimasartan, a new angiotensin II receptor antagonist, with amlodipine in healthy volunteers. J Cardiovasc Pharmacol. 2011 Jun;57(6):682-9. doi: 10.1097/FJC.0b013e31821795d0.
Clinical trial NCT04133597: The Relationship Among Electroencephalography,Skin Conductance Response,Heart Rate Variability and Mental Health Among Smartphone Users After Receiving Texting or Calling
Official title: The Relationship Among Electroencephalography,Skin Conductance Response,Heart Rate Variability and Mental Health Among Smartphone Users After Receiving Texting or Calling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smartphone Users, Smartphone Addiction, Anxiety, and Skin Conductance
Keywords: skin conductance
anxiety
smartphone users
smartphone addiction
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2019-10-21
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The number of smartphone users in Taiwan continues to increase exponentially. Smartphone addiction tends to not only disrupt the ability of social communication but cause physical and psychological problems as well. This study examined the relationship among skin conductance, electroencephalography, heart rate variability (HRV), social interaction anxiety and smartphone addiction among Line apps users, and we also tried to identify associated factors for further interventions.


Eligibility criteria: Inclusion Criteria:

(a) were older than 20 years of age and (b) used a smartphone with internet and Line app.

Exclusion Criteria:

the participants were those who (a) had alcoholism or drug dependence; (b) had any pre-existing major mental disorders; (c) had history of brain injury; and (d) had palmar hyperhidrosis.

Primary outcomes:
measure: skin conductance
timeFrame: 3 minutes
measure: Heart Rate Variability (HRV)
timeFrame: 3 minutes
measure: Electroencephalography (Hz)
timeFrame: 5 minutes
Secondary outcomes:
measure: The Zung Self-Rating Anxiety Scale
timeFrame: 10 minutes
measure: The Chinese version of Smartphone Addiction Inventory (SPAI)
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University
Study officials:
References:
Clinical trial NCT02687997: Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort
Official title: Prevalence of Sleep Apnea in a Lung Cancer Screening Cohort Meeting NLST Criteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Hypopnea Syndrome
COPD
Emphysema
Lung Cancer
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 282
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective study of sleep disordered breathing in a lung cancer screening cohort.

Detailed description: The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.

Eligibility criteria: Inclusion Criteria:

* Age 55-75.
* \> 30 pack years tobacco exposure.
* Enrolled in lung cancer screening program.

Exclusion Criteria:

* Inability or unwillingness to undergo a home sleep study.

Primary outcomes:
measure: Prevalence of sleep apnea
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
References:
Clinical trial NCT01857297: A Study to Assess the Immunogenicity and Safety of CSL's 2013/2014 Formulation of Enzira® Vaccine in Healthy Volunteers
Official title: A Phase IV, Single-Centre, Open-label Study to Evaluate the Immunogenicity and Safety of the 2013/2014 Formulation of the Enzira® Vaccine in Two Groups of Healthy Volunteers: 'Adults' (Aged 18 to 59 Years) and 'Older Adults' (Aged 60 Years or Older).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza, Human
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study to assess the immune (antibody) response and safety of the 2013/2014 formulation of Enzira® vaccine in healthy adult volunteers aged 18 years or older.


Eligibility criteria: Inclusion Criteria:

* Males or females aged 18 years or older at the time of vaccination.
* Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) must be abstinent or be willing to use a medically accepted contraceptive regimen for the duration of the study. Females of child-bearing potential must return a negative urine pregnancy test result prior to vaccination with the vaccine.

Exclusion Criteria:

* Known hypersensitivity to a previous vaccination with influenza vaccine or allergy to eggs, ovalbumin, chicken protein, neomycin, polymyxin, or any components of the vaccine.
* Clinical signs of an active infection.
* A clinically significant medical condition.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Females who are pregnant or lactating.

Primary outcomes:
measure: The Percentage of Evaluable Participants Achieving Seroconversion or Significant Increase in Antibody Titre.
timeFrame: Approximately 21 days after vaccination
measure: The Geometric Mean Fold Increase (GMFI) in Antibody Titre After Vaccination.
timeFrame: Approximately 21 days after vaccination
measure: The Percentage of Evaluable Participants Achieving a HI Titre ≥ 40 or Single Radial Haemolysis (SRH) Area ≥ 25 mm2.
timeFrame: Approximately 21 days after vaccination
Secondary outcomes:
measure: Frequency of Any Solicited Adverse Events (AEs)
timeFrame: During the 4 days after vaccination (Day 0 plus 3 days)
measure: Frequency of Any Unsolicited AEs
timeFrame: After vaccination until the end of the study; approximately 21 days.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Study Site
Study officials:
affiliation: Seqirus
name: Clinical Director Vaccines
role: STUDY_DIRECTOR
References:
Clinical trial NCT06023797: Neoadjuvant Immunochemotherapy for Lung Cancer
Official title: Retrospective Research on Lung Cancer Patients Receiving Neoadjuvant Immunochemotherapy From Zhongshan Hospital Fudan University.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: neoadjuvant therapy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-09-05
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who received NAICT and were operated at the Department of Thoracic Surgery, Zhongshan Hospital Fudan University between 2017 and 2022.

Brief summary: We retrospectively analyzed lung cancer patients who had NAICT and surgery in the Department of Thoracic Surgery, Zhongshan Hospital. NAICT was defined as chemotherapy that included at one application of PD-1 inhibitor.


Eligibility criteria: Inclusion Criteria:

1. Lung surgery was performed in the Department of Thoracic Surgery at Zhongshan Hospital;
2. At least one cycle of neoadjuvant treatment containing the immune drug PD-1 immunosuppressant was performed before surgery;
3. Malignancy was present and confirmed in the pathology before treatment and after surgery;
4. The lung lesion was the primary lesion.

Exclusion Criteria:

1. No lung surgery was performed until 2022.11;
2. No preoperative neoadjuvant therapy was performed or recorded;
3. Neoadjuvant therapy did not include immune drugs;
4. Previous history of malignancy (including surgery and adjuvant therapy);
5. Previous use of system-related immune medicines, such as immunosuppressants and monoclonal antibodies; and 6. Other conditions inappropriate for enrollment by the investigator.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 2017-2023
measure: Overall survival (OS)
timeFrame: 2017-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhencong Chen
state: Shanghai
Study officials:
References: