louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03932045: A Study to Evaluate the Safety and Efficacy of SYB Filler(SF-01) in the Correction of Nasolabial Folds
Official title: A Randomized, Subject & Evaluator-blind, Matched Pairs, Prospective Study to Compare the Safety and Efficacy Between SYB Filler (SF-01) and Ellansé M in the Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasolabial Folds
Lead sponsor: Samyang Biopharmaceuticals Corporation
Sponsor class: INDUSTRY
First posted: 2019-04-30
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized, Subject \& Evaluator-blind, Matched pairs, Prospective Study
Primary purpose: TREATMENT

Brief summary: The objective of this clinical trial is to verify the safety and efficacy of SYB Filler (SF-01) in the temporary improvement of Nasolabial Folds.


Eligibility criteria: Inclusion Criteria:

1. Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS)
2. Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this study.

Exclusion Criteria:

1. Administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening
2. Administered Vitamin E or non-steroidal anti-inflammatory drugs or Collagen within 1 week of the date of the screening, or who require these during the period of the study
3. History of bleeding disorder in past or present
4. Received deep-peeling, skin regeneration, plastic surgery (including botulinum toxin injection), wrinkle improvement or acne scar treatment in the facial area within 24 weeks of the date of the screening
5. Administered an hyaluronic acid filler within 24 weeks of the date of the screening

Primary outcomes:
measure: Change From Baseline to 12months in Wrinkle Severity Rating Scale (WSRS) Score by independent evaluator assessed
timeFrame: 12months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Beom Joon KIM, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01707745: Efficacy and Safety of Intravitreal Bevacizumab for Threshold ROP.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stage 2+ or Stage 3+ Retinopathy of Prematurity in Zone I or Zone II.
Lead sponsor: Dubai Health Authority
Sponsor class: OTHER_GOV
First posted: 2012-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 32
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective study to evaluate the efficacy and safety of intravitreal bevacizumab In retinopathy of prematurity (ROP).

Bevacizumab 0.75 mg in 0.03 ml was given to stage 2+ or stage 3+ ROP in Zone I or Zone II.


Eligibility criteria: Inclusion Criteria: stage 2+ or stage 3+ Retinopathy of prematurity in Zone I or Zone II.

Informed written consent by parents or guardian.

-

Exclusion Criteria:

Refusal to give consent Critically ill neonates.

-

Primary outcomes:
measure: Regression Of ROP
timeFrame: Minimum 6 months follow up after intravitreal Avastin
Secondary outcomes:
measure: Recurrence of ROP
timeFrame: minimum 6 months of follow up.
Other outcomes:
Locations:
city: Dubai
country: United Arab Emirates
facility: Dubai Hospital
state: UAE
Study officials:
References:
Clinical trial NCT03345745: Saliva Levels of S100A12, CRP, Fetuin-A in Periodontal Disease Patients
Official title: The Short-Term Effects of Non-Surgical Periodontal Therapy on The Saliva Levels of S100A12, High-Sensitivity C-Reactive Protein and Fetuin-A in Patients With Gingivitis and Chronic Periodontitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Inflammation
Keywords: Fetuin-A
S100A12
C-Reactive Protein
Chronic Periodontitis
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 54
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty-four patients (27 women) aged 25-45 years who had presented to our faculty for periodontal and other dental problems and consented to participate were enrolled in the study.

Group 1 - subjects with healthy periodontal status Group 2 - subjects with untreated gingivitis Group 3 - subjects with untreated chronic periodontitis (indicted by radiographic evidence of bone loss and clinical attachment loss \> 5 mm in more than six teeth)

Brief summary: Hs-CRP, Fetuin-A and S100A12 are acute phase proteins associated with many systemic diseases and conditions. The aim of this study was to determine the clinical parameters and salivary Hs-CRP, Fetuin-A and S100A12 levels before and after non-surgical periodontal treatments in the patients with periodontal diseases.

A total of 54 subjects were divided in to three groups; periodontally healthy (n: 18), gingivitis (n: 18), chronic periodontitis (n: 18). Clinical periodontal parameters, salivary Hs-CRP, Fetuin-A and S100A12 levels and salivary flow rates were evaluated at baseline and a month after the treatments. Salivary Hs-CRP, Fetuin-A and S100A12 levels were assayed by ELISA.


Eligibility criteria: Inclusion Criteria:

never-smokers no history of systemic disease no patients had been under periodontal therapy and medicine for at least 6 months before the study no pregnancy or lactation no alcohol or antioxidant vitamin consumption.

Exclusion Criteria:

-

Primary outcomes:
measure: Salivary acute phase proteins
timeFrame: Baseline - a month after the periodontal treatments
measure: Salivary acute phase proteins
timeFrame: Baseline - a month after the periodontal treatments
measure: Salivary acute phase proteins
timeFrame: Baseline
Secondary outcomes:
measure: Evaluating periodontal health
timeFrame: Baseline - a month after the periodontal treatments
measure: Evaluating periodontal health
timeFrame: Baseline - a month after the periodontal treatments
measure: Evaluating periodontal health
timeFrame: Baseline
measure: Evaluating periodontal health
timeFrame: Baseline - a month after the periodontal treatments
measure: Evaluating periodontal health
timeFrame: Baseline - a month after the periodontal treatments
Other outcomes:
Locations:
city: Ordu
country: Turkey
facility: Ordu University
Study officials:
References:
Clinical trial NCT06138145: Inclusion Appeal Videos and Intent to Register for Pediatric Clinical Trials
Official title: Testing the Impact of Appeals to Diversity and Inclusion in Pediatric Clinical Research Study Enrollment Videos: a Baseline Assessment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Participation
Pediatric ALL
Keywords: Inclusion Study
African American Study
African American Pediatrics
Appeal Videos
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2023-11-18
Enrollment: 125
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: An informational video about joining a Research Notification Registry is being compared with a version of the video tailored to African/ African American parents, reminding them about the importance of their being included in clinical trials. African/African American parents and caregivers of children under 13 years of age are targeted.

Detailed description: Improving diversity in research projects and national data repositories is critical to providing safe and effective care to marginalized groups. Unfortunately, certain groups such as African Americans are inadequately represented in much of the available data and in current clinical trials. Recently, investigators have begun employing new messaging approaches to increase diversity in clinical trial enrollment. These messages are typically designed to inform, with no appeal for specific groups to act, and no tailoring that takes into account specific groups. Very little is known about the potential impact of inclusion appeals--direct appeals to historically marginalized groups calling on their need to be included in research studies. Applying the science of appeals to recruitment messages may improve the effectiveness of educational videos and lead to greater participation in research. This pilot study proposes to empirically study whether an inclusion appeal increases decisions to enroll children in studies.

Eligibility criteria: Inclusion:

1. English speaking
2. Self-identified African or African American
3. Not already enrolled in any research participant registry, no history of clinical trial participation
4. At least one child in their care age newborn to 13

Exclusion:

1. Parents with children over the age of 13
2. Non-English speakers
3. Previously enrolled in Children's Hospital of Philadelphia registry, history of clinical trial participation

Primary outcomes:
measure: Participants' Decision to Enroll in the CHOP Pediatric Clinical Trials Registry
timeFrame: Up to 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: CHOP Primary Care, Cobbs Creek
state: Pennsylvania
Study officials:
References:
Clinical trial NCT01870245: A Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 in Healthy Volunteers
Official title: A Phase 1 Multiple Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ACHN-975 Administered Intravenously to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Achaogen, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 4
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: This is a randomized, double-blind, placebo-controlled, multiple-dose study, designed to assess the safety, tolerability, and pharmacokinetics (PK) of ACHN-975. This study will take place in the US at one clinical site.


Eligibility criteria: Key Inclusion Criteria:

* Body weight between 40 and 100 kilograms (between \~88 pounds and \~220 pounds)
* Use of contraception
* Stable health
* Negative tests for alcohol, tobacco, and drugs of abuse

Key Exclusion Criteria:

* History of clinically significant disease
* Pregnancy

Primary outcomes:
measure: Frequency of AEs
timeFrame: 28 days
measure: Severity of AEs
timeFrame: 28 days
Secondary outcomes:
measure: Plasma concentrations of ACHN-975
timeFrame: 16 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Investigational Site
state: Kansas
Study officials:
affiliation: Achaogen, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05766345: BCG-induced Epigenetic Modifications in the NEXT Generation
Official title: BCG-induced Epigenetic Modifications in the NEXT Generation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Trained Immunity
BCG Vaccine
Epigenetics
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2023-03-13
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Non-specific protective effects resulting from the BCG vaccine appear to be paternally inheritable. Since the BCG vaccine is known to induce trained immunity, epigenetics might explain the fathers' contribution to the immune profile of their offspring. Epigenetic inheritance in mice has recently been demonstrated, but is not established in humans yet. By studying the DNA methylation profile of sperm cells after BCG vaccination, we aim to gain insight into the possibility of epigenetic inheritance in human males.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Male
* Age 18-25 years (at the moment of trial start)

Exclusion Criteria:

* Any systemic disease or conditin, or the use of systemic medication (with the exception of non-threatening alelrgies, e.g. hay fever)
* Smoking or drug use
* Prior BCG vaccination
* Other vaccination four weeks prior to trial start or four weeks after the first study visit (no vaccine in the same arm as the BCG vaccine for three months)
* Acute illness two weeks prior to trial start
* Known allergy or history of anaphylaxis/other serious adverse reaction to any vaccine
* Participation in another drug trial
* Legally incapacitated or unwilling to provide informed consent

Primary outcomes:
measure: DNA methylation profile of sperm cells (first comparison; CHANGE)
timeFrame: Comparing T3 to baseline
measure: DNA methylation profile of sperm cells (second comparison; CHANGE)
timeFrame: Comparing T4 to baseline
Secondary outcomes:
measure: Immunological profile of PBMCs, before and after BCG vaccination (comparison; CHANGE)
timeFrame: Comparing T1-T4 to baseline
measure: CHANGE of the epigenetic profile of innate immune cells
timeFrame: Comparing T1-T4 to baseline
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
References:
Clinical trial NCT02511145: Comparison of Mechanical Penetration Enhancers on Metvixia Skin Penetration
Official title: Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: volunteers
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2015-07-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Exploratory, mono-center, randomized, intra-individual, controlled trial involving healthy volunteers to compare the effect on MAL penetration into the skin following various mechanical penetration enhancement techniques.

Detailed description: At baseline, each mini-zone was selected and randomly assigned to a pretreatment: 3 zones with microneedling Dermaroller®, 3 zones with ablative fractional CO2 Laser, and 3 zones with no pretreatment. After performing pretreatment, MAL cream was applied on the 6 assigned mini-zones for 3 hours incubation. Each condition was tested with and without occlusion. The three mini-zones with no product applied were used to perform biophysics measures.

Eligibility criteria: Inclusion Criteria:

* Male or female of non childbearing potential, who is at least 18 years of age or older at screening visit.
* The subject has a skin phototype of I to III on Fitzpatrick's scale (Fitzpatrick et al., 1993) at screening visit.
* Subject should have 9 mini zone areas on the back that will be able to receive pre-treatments according to protocol. (checked at Screening visit, and assigned at Baseline visit)
* Female of non childbearing potential (postmenopausal \[absence of menstrual bleeding for 1 year prior to screening visit, without any other medical reason\], hysterectomy or bilateral oophorectomy).

Exclusion Criteria:

* Subject with porphyria,
* Subject with past history of skin cancer, or current clinical diagnosis of other skin disease (including non-melanoma skin cancer), or tattoos, or cheloid and hypertrophic scars on the test zones, which, in the opinion of the investigator, might interfere with the interpretation of the clinical results,
* Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
* Known or suspected allergies or sensitivities to any components of any of the study drugs (see Product label).
* The subject has received, applied or taken some specific treatments within specified time frame prior to the baseline visit

Primary outcomes:
measure: fluorescence of protoporphyrin IX (PpIX)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01850745: Multidisciplinary Support Program in Chronic Hepatitis C
Official title: Evaluation of a multidìsciplinary Support Program in the Adherence and Efficacy of Peginterferon Alfa-2a and Ribavirin Therapy in Chronic Hepatitis C.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Keywords: Chronic hepatitis C virus infection (CHC)
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 447
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hepatitis C virus infection (CHC)

Brief summary: Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (recruited 2002-2004, n= 147), MSP-pilot group (recruited 2005-2006, n=131), and MSP-validation group (recruited 2007-2009, n=169).

Detailed description: Adherence to antiviral treatment in chronic hepatitis C (CHC) is an important factor to achieve sustained virological response (SVR). The aim of our study is to evaluate the efficacy of a multidisciplinary support program (MSP) in adherence to and efficacy of pegylated interferon alfa-2a and ribavirin compared to the conventional approach. We assessed 447 patients with CHC receiving antiviral treatment distributed into 3 groups: control group (follow-up 2002-2004, n= 147), MSP-pilot group (follow-up 2005-2006, n=131), and MSP-validation group (follow-up 2007-2009, n=169).A cost-effectiveness analysis was performed using a Markov model.

Eligibility criteria: Inclusion Criteria:

* Patients with chronic hepatitis C eligible to receive antiviral treatment.

Exclusion Criteria:

* Patients who had undergone previous antiviral treatment, those with human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection, and individuals included in other treatment protocols.

Primary outcomes:
measure: Adherence to Treatment
timeFrame: 48 months
Secondary outcomes:
measure: Efficacy of Treatment Measured by Sustained Virological Response
timeFrame: baseline and 72 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Hsopital del Mar, Parc de Salut MAR
name: Ricard Sola, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01943045: Phase 2 Study of NGM282 in Patients With Type 2 Diabetes
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multiple Center Study to Evaluate the Safety, Tolerability, and Activity of NGM282 Administered for 28 Days to Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus
Lead sponsor: NGM Biopharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: NGM Biopharmaceuticals Australia Pty Ltd
First posted: 2013-09-16
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Type 2 Diabetes.


Eligibility criteria: Inclusion Criteria:

* Males or females, between 18 and 70 years of age, inclusive
* BMI range of 24-40 kg/m2, inclusive
* No active coronary artery disease
* Resting heart rate in the range of 40-100 bpm

Exclusion Criteria:

* Diagnosis of Type 1 diabetes
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance

Primary outcomes:
measure: Fasting Plasma Glucose
timeFrame: 28 days
Secondary outcomes:
measure: HbA1c
timeFrame: 28 days
measure: Lipids
timeFrame: 28 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: NGM Clinical Study Site 6103
state: Victoria
city: Melbourne
country: Australia
facility: NGM Clinical Study Site 6104
state: Victoria
city: Perth
country: Australia
facility: NGM Clinical Study Site 6101
state: Western Australia
city: Auckland
country: New Zealand
facility: NGM Clinical Study Site 6403
city: Auckland
country: New Zealand
facility: NGM Clinical Study Site 6405
city: Christchurch
country: New Zealand
facility: NGM Clinical Study Site 6401
city: Dunedin
country: New Zealand
facility: NGM Clinical Study Site 6406
city: Tauranga
country: New Zealand
facility: NGM Clinical Study Site 6404
city: Wellington
country: New Zealand
facility: NGM Clinical Study Site 6402
Study officials:
affiliation: NGM Biopharmaceuticals, Inc
name: Alex M DePaoli, MD
role: STUDY_DIRECTOR
References:
citation: DePaoli AM, Zhou M, Kaplan DD, Hunt SC, Adams TD, Learned RM, Tian H, Ling L. FGF19 Analog as a Surgical Factor Mimetic That Contributes to Metabolic Effects Beyond Glucose Homeostasis. Diabetes. 2019 Jun;68(6):1315-1328. doi: 10.2337/db18-1305. Epub 2019 Mar 12.
Clinical trial NCT04575545: Prevalence of COVID-19 Infection in a Cohort of Patients Infected by the HIV and Patients Taking PrEP
Official title: Prevalence of COVID-19 Infection in a Cohort of Patient Infected by the HIV and Patients Taking PrEP Pre-exposure Prophylaxis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Virus-HIV
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients infected by the HIV on treatment and patients taking PreP

Brief summary: The purpose of the study is to assess seroprevalence of COVID-19 infection in a cohort of HIV + patients and in a cohort of patients taking PrEP by emtricitabine / tenofovir.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18 years
* patients infected by the HIV on treatment
* patients taking PreP (Pre-exposure prophylaxis (PrEP))
* Being affiliated with or benefiting from a social security scheme

Exclusion Criteria:

* Subject to a measure for the protection of justice

Primary outcomes:
measure: % of patients with positive serological tests for covid-19
timeFrame: 3 months
Secondary outcomes:
measure: Presence and quantification of CD4 / CD8 reactivity to COVID-19 epitopes in patient with positive and negative serological tests for covid-19
timeFrame: 3 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: BENNANI
Study officials:
affiliation: Hôpital Europeen Marseille
name: Patrick PHILIBERT
role: PRINCIPAL_INVESTIGATOR
References: