louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02070926: The CRONOS-ADM Registry
Official title: Coronary CT Angiography Evaluation for Clinical Outcomes in Asymptomatic Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asymptomatic Patients With Type 2 Diabetes Mellitus
Atherosclerosis
Coronary Artery Disease
Cardiovascular Disease
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2014-02-25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consist of patients with asymptomatic type 2 diabetes mellitus at two centers of catholic university of Korea

Brief summary: The CRONOS-ADM (Coronary CT angiography evaluation for clinical outcomes in asymptomatic patients with type 2 diabetes mellitus) registry is a large, prospective observational registry of demographic, clinical and laboratory data with long-term clinical outcome of asymptomatic diabetic patients without history of CAD or angina or angina-equivalent symptoms at two affiliated hospitals of The Catholic University of Korea.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. Asymptomatic type 2 diabetes mellitus
3. Prospective data collection for CAD risk factors

Primary outcomes:
measure: Time to major adverse events
timeFrame: up to median 3 years follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
References:
citation: Lee EY, Yang HK, Lee J, Kang B, Yang Y, Lee SH, Ko SH, Ahn YB, Cha BY, Yoon KH, Cho JH. Triglyceride glucose index, a marker of insulin resistance, is associated with coronary artery stenosis in asymptomatic subjects with type 2 diabetes. Lipids Health Dis. 2016 Sep 15;15(1):155. doi: 10.1186/s12944-016-0324-2.
Clinical trial NCT06392126: Personalized Antisense Oligonucleotide Therapy for A Single Participant With CHCHD10 ALS
Official title: An Open-label Study of an Experimental Antisense Oligonucleotide Treatment for a Single Participant With Amyotrophic Lateral Sclerosis (ALS) Due to a Pathogenic Variant in CHCHD10
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: n-Lorem Foundation
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2024-04-30
Enrollment: 1
Sex: MALE
Minimum age (years): 48
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in CHCHD10

Detailed description: This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single participant with amyotrophic lateral sclerosis (ALS) due to a pathogenic variant in CHCHD10

Eligibility criteria: Inclusion Criteria:

* Informed consent/assent provided by the participant (when appropriate), and/or participant's parent(s) or legally authorized representative(s).
* Ability to travel to the study site and adhere to study-related follow-up examinations and/or procedures and provide access to participant's medical records.
* Genetically confirmed neurological disorder.

Exclusion Criteria:

* Participant has any condition that in the opinion of the Site Investigator, would ultimately prevent the completion of study procedures.
* Use of an investigational medication within less than 5 half-lives of the drug at enrollment

Primary outcomes:
measure: Clinical Functioning
timeFrame: Baseline to 12 months
measure: Clinical Functioning
timeFrame: Baseline to 12 months
measure: Clinical Functioning
timeFrame: Baseline to 12 months
measure: Clinical Functioning
timeFrame: Baseline to 12 months
Secondary outcomes:
measure: Disease biomarkers
timeFrame: Baseline to 12 months
measure: Safety and tolerability
timeFrame: Baseline to 12 months
measure: Safety and tolerability
timeFrame: Baseline to 12 months
measure: Safety and tolerability
timeFrame: Baseline to 12 months
measure: Safety and tolerability
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Björn E. Oskarsson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03285126: Pompe Gene Therapy- Screening for Eligibility
Official title: Screening for Eligibility to Participate in a Clinical Trial of Gene Therapy for Late-onset Pompe Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pompe Disease (Late-onset)
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with late on-set Pompe Disease.

Brief summary: The purpose of this study is to determine eligibility for the future clinical trial of gene therapy in adults with late-onset Pompe disease.

This screening protocol will enroll up to 20 adults patients (\>=18 yo) with late-onset Pompe disease. Study assessments include review of medical history, vital signs, physical examination, muscle function testing, lung function testing, blood and urine collection, serum pregnancy test and ECG.

The study results will be collected to perform descriptive statistical analysis and used to determine eligibility for the proposed clinical trial of gene therapy in the future.


Eligibility criteria: Inclusion Criteria

* Diagnosis of Pompe disease by blood or skin fibroblast GAA assay and two pathogenic variants in the GAA gene.
* Age: at least 18 years at enrollment.
* Subjects are capable of giving written consent.
* Receiving ERT at a stable dose for at least 104 weeks.

Exclusion Criteria

* Any condition that would interfere with participation in the study as determined by the principal investigator.
* Pregnancy or nursing mothers.
* History of active hepatitis B, hepatitis C, or cirrhosis
* Receiving any investigational agent.

Primary outcomes:
measure: Eligibility for gene therapy.
timeFrame: Up to 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Dwight Koeberl
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00518726: Safety and Immunogenicity of a Commercially Available Influenza Vaccine (Formulation 2007/2008) When Administered to NON Elderly AND Elderly Subjects
Official title: A Phase II, Open Label, Uncontrolled, Multi Center Study to Evaluate Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Surface Antigen, Inactivated, Formulation 2007-2008, When Administered to Non-Elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Adjuvanted Influenza Vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-08-21
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged \> 18 years


Eligibility criteria: Inclusion Criteria:

* \> 18 years of age or older

Exclusion Criteria:

* any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days, any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days.No women in breast feeding.

Primary outcomes:
measure: Safety and immunogenicity of seasonal inactivated, influenza vaccine, formulation 2007-2008, when administered to non-elderly adult and elderly subjects
Secondary outcomes:
Other outcomes:
Locations:
city: Via dei Vestini
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G. D'Annunzio
state: Chieti
city: Via S. Spaventa, 37, Lanciano
country: Italy
facility: Ufficio Igiene e Sanità Pubblica di Lanciano, ASL Lanciano - Vasto sede legale
state: Chieti
city: Siena
country: Italy
facility: Presidio Distrettuale No. 8 Azienda Sanitaria USL 7 di Siena
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
Clinical trial NCT06281626: Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25
Official title: Use of the Free Male Condom Scheme in Young Adults Aged 18 to 25
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Comdom
Keywords: Young adults
condom
free condom
use of condom
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People aged 18 to 25 years.

Brief summary: For several years, the incidence of sexually transmitted infections (STIs) has been rising sharply, while that of HIV has stagnated. This is due to the decline in condom use since the late 1990s, despite the fact that condom are considered the only effective way to prevent STIs.

In France, 40% of STIs concern young people aged 15 to 25. The national public health strategy aims to stem the circulation of HIV and eliminate STIs as a major public health problem by 2030. To achieve this, several measures have been implemented: reimbursement of male condoms on prescription (2018), 100% free contraception and prevention in sexual health consultation (2021), and more recently, free, non-prescription access to male condoms in pharmacies (end 2022).

Detailed description: The main objective is to describe the use of free male condoms by young adults aged 18 to 25.

Eligibility criteria: Inclusion Criteria:

* Aged 18 to 25 years
* Male or female
* Regardless of their sexual orientation
* Agreeing to participate in the study

Exclusion Criteria:

* Minors
* Refusing to participate in the study.

Primary outcomes:
measure: use of free male condoms
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Ufr Medecine Urca
city: Reims
country: France
facility: Université de Reims Champagne Ardenne
Study officials:
References:
Clinical trial NCT06417957: Cultural Competence Education Given According to the Peer Education Model
Official title: The Effect of Cultural Competence Education Given According to the Peer Education Model on the Cultural Competence Levels of Student Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Culture Shock
Cultural Competence
Keywords: cultural knowledge, cultural practice, cultural sensitivity, cultural competence
Lead sponsor: Istanbul Aydın University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-05-16
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1: Experimental group (Education group) Goup 2: Control group
Primary purpose: OTHER

Brief summary: The aim of the study is to determine the effect of cultural competence education given according to the peer education model on the cultural competence levels of student nurses.

Detailed description: Nursing students will be given cultural competence training (with peer education model) and then the effectiveness of this training will be evaluated.

Eligibility criteria: Inclusion Criteria

* Not receiving training on cultural competence,
* Participated in Cultural Competence Peer Training for the experimental group,
* Filled out the survey 3 times on the specified dates for the experimental and control groups,
* Volunteer to participate in the research,
* 3rd and 4th year nursing students.

Exclusion criteria:

* Receiving training on cultural competence,
* Not participating in Cultural Competency Peer Training for the experimental group,
* Failure to fill out the survey 3 times on the specified dates for the experimental and control groups,
* Those who do not volunteer to participate in the research,
* 1st and 2nd year nursing students,
* Students who want to leave the study.

Primary outcomes:
measure: Cultural Competence Assessment Tool
timeFrame: Before training, immediately in the first and third months after training
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Aydın Üniversity
Study officials:
References:
Clinical trial NCT03192657: Basiliximab Treating Interstitial Pneumonia of CADM
Official title: Basiliximab as a Treatment of Interstitial Pneumonia in Clinical Amyopathic Dermatomyositis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung; Disease, Interstitial, With Fibrosis
Dermatomyositis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 52-week, randomized, open and routine treatment controlled study. This study will assess the safety and efficacy of basiliximab as an add-on treatment for interstitial pneumonia in clinical amyopathic dermatomyositis (CADM) patients. 100 CADM patients are planned to be enrolled in a single center.


Eligibility criteria: Inclusion Criteria:

* Fulfill Sontheimer-Bohan-Peter diagnosis criteria for dermatomyositis.
* Agreement of contraception.
* Serum creatine Kinase ≤ 1.5 fold of upper normal level.
* Interstitial pneumonia:

(meet at least two in four of following)

1. interstitial pneumonia images in high resolution CT;
2. DLCO (diffusing capacity)≤ 60% predict in lung function test;
3. elevated serum KL-6;
4. serum anti-MDA5 (+).

Exclusion Criteria:

* Previous application of immunosuppressives or any target treatment for dermatomyositis.
* Clinically significant active infection including ongoing and chronic infections History of human immunodeficiency virus (HIV).
* Confirmed Positive tests for hepatitis B or positive test for hepatitis C Active tuberculosis.
* Abnormal renal function at screening (serum creatine\>300μmol/L，or eGFR\<60mL/min/1.73m2, or end-stage renal disease).
* Abnormal liver function test at screening (ALT, AST or total bilirubin over 2 fold of upper normal level.
* History of any malignancy.

Primary outcomes:
measure: Survival
timeFrame: 52 week
Secondary outcomes:
measure: Forced vital capacity
timeFrame: 52 week
measure: Total lung capacity
timeFrame: 52 week
measure: Diffusing capacity
timeFrame: 52 week
measure: Lung CT change
timeFrame: 52 week
measure: Serum ferritin
timeFrame: 52 week
measure: Serum KL-6
timeFrame: 52 week
Other outcomes:
Locations:
city: Shanghai
country: China
facility: RenJi Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT05608057: Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation
Official title: Vitamin C Mesotherapy Versus Diode Laser for the Management of Physiologic Gingival Pigmentation (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingival Pigmentation
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physiologic pigmentation affects the gingival esthetics. Laser ablation has been recently used as the most effective and reliable technique for gingival depigmentation. However, the high cost of laser technology limits its use in dental practice. Vitamin C/Ascorbic acid mesotherapy has been proposed as a minimally invasive, safe, cost-effective new modality of treatment.


Eligibility criteria: Inclusion Criteria:

* Adults between 18 and 45 years old with physiologic melanin pigmentation in the anterior esthetic portion of the maxillary or mandibular gingiva.
* Systemically free

Exclusion Criteria:

* Smokers.
* Drugs intake, which associates with gingival melanin pigmentation.
* Pregnant and lactating women.
* Patients with known hypersensitivity to ascorbic acid.
* Patients with bad oral hygiene.
* Pigmentation of the gingiva due to heavy metal ingestion

Primary outcomes:
measure: Change in gingival pigmentation score
timeFrame: baseline, 1 month, 2 months
Secondary outcomes:
measure: Change in pain score
timeFrame: up to 1 week
measure: Patient satisfaction
timeFrame: after 2 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria Faculty of Dentistry
Study officials:
affiliation: Alexandria University, Faculty of Dentistry
name: Sara Esmat, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01579357: Pharmacokinetics and Metabolic Activation of Capecitabine
Official title: Pharmacokinetics and Metabolic Activation of Capecitabine When Given Concomitantly With Oxaliplatin and the Monoclonal Antibody Cetuximab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Keywords: colorectal carcinoma
K-ras wild type
Capecitabine
Cetuximab
Oxaliplatin
Pharmacokinetics
exclude a possible influence of CETUX
plasma disposition
metabolic activation
CCB
OxPt
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2012-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this pharmacokinetic study is to exclude a possible influence of CETUX on the plasma disposition and metabolic activation of Capecitabine (CCB) and when this regimen is given combined with Oxaliplatin (OxPt).


Eligibility criteria: Inclusion Criteria selected:

* signed written informed consent
* male or female \> 18 years
* K-ras wild type adenocarcinoma of the colon or rectum
* metastatic colorectal carcinoma
* ECOG \<= 2

Exclusion Criteria selected:

* brain metastasis
* previous chemotherapy
* stage 3 or 4 heart failure
* uncontrolled angina
* pregnancy or lactation

Primary outcomes:
measure: Influence of Cetuximab on metabolic activation of Capecitabine
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: PMU Salzburg
city: Vienna
country: Austria
facility: AKH Wien
city: Vienna
country: Austria
facility: Kaiser Franz Josef Spital
Study officials:
References:
Clinical trial NCT06109857: Bladder Bank (a Prospective Banking Study)
Official title: Bladder Bank (a Prospective Banking Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bladder Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient has undergone office-based evaluation for hematuria

Brief summary: This study collects blood and urine samples from patients with bladder cancer to support the development of tests for early detection of bladder cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To establish a biobank of samples (blood and urine) to support the development of non-invasive tests for early detection of bladder cancer.

OUTLINE: This is an observational study.

Patients undergo blood and urine sample collection and have their medical records reviewed while on study.

Eligibility criteria: Inclusion Criteria:

* Age \&amp;gt; 18 years
* Patient has undergone office-based evaluation for hematuria \[computed tomography (CT), ultrasound, cystoscopy\]

Exclusion Criteria:

* Patient has known cancer outside of the target cancer 5 years prior to current collection (not including basal cell or squamous cell skin cancers; if patient has not been seen or if information is not available, the patient is eligible)
* Patient has recurrent muscle invasive bladder cancer
* Patient has ever been previously diagnosed with UTUC (upper tract urothelial carcinoma) prior to bladder resection
* Patient has received chemotherapy class drugs for the treatment of non-target origin cancer in the 5 years prior to current collection
* Patient has had any prior radiation therapy to the target lesion prior to current collection
* Patient has had a biopsy to the target organ and/or lesion within 3 days before collection
* Patient has undergone cystectomy or cystoprostatectomy
* Patient has transurethral instrumentation (placement of urinary catheter) within 7 days prior to urine collection
* Patient has had a urinary tract infection within 14 days prior to urine collection
* Patient has chronic indwelling urinary catheter

Primary outcomes:
measure: Blood sample to support the development of non-invasive tests for early detection of bladder cancer
timeFrame: Baseline (at enrollment)
measure: Urine sample to support the development of non-invasive tests for early detection of bladder cancer
timeFrame: Baseline (at enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: John B. Kisiel, MD
role: PRINCIPAL_INVESTIGATOR
References: