louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00292513: Clinical Trial Comparing Tissue Adhesive Vs. Absorbable Suture Vs. Non-Absorbable Suture
Official title: A Randomized Clinical Trial Comparing Tissue Adhesive (2-Octylcyanoacrylate) Vs. Absorbable Suture Vs. Non-Absorbable Suture for the Closure of Low Tension Facial and Neck Wounds in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cyst of Face, Neck or Shoulder
Pilomatrixoma of Face, Neck or Shoulder
Lead sponsor: Rady Children's Hospital, San Diego
Sponsor class: OTHER
First posted: 2006-02-16
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Standard suture is superior to both tissue adhesive (2-octyl cyanoacrylate) and absorbable sutures with respect to cosmetic outcome of, complication rate of and parental satisfaction with the closure of low tension facial, neck and shoulder, wounds in children and adolescents


Eligibility criteria: Inclusion Criteria:

* Age less than or equal to 18
* Pre-operative diagnosis of cyst or pilomatrixoma of neck, face or shoulder
* outpatient scheduled for outpatient or day surgery at Children's Hospital San Diego

Exclusion Criteria:

* known hypersensitivity to cyanoacrylate or formaldehyde
* lesions with any evidence of active infection or gangrene
* lesions on or across mucocutaneous surfaces
* lesions in which skin may be regularly exposed to body fluids
* lesions located in areas of dense natural hair (ie scalp)
* patients with peripheral vascular disease, insulin dependent diabetes mellitis or blood clotting disorders
* patients with known immunodeficiencies
* inability to return for follow-up

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Children's Hospital San Diego
state: California
Study officials:
affiliation: Rady Children's Hospital, San Diego
name: Bari B Cunningham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06198413: LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Official title: A Dose-Escalation Study of LX102 Gene Therapy for Neovascular Age-Related Macular Degeneration (nAMD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Age-related macular degeneration
AMD
Neovascular AMD
Neovascular age-related macular degeneration
Lead sponsor: Innostellar Biotherapeutics Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-10
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.

Detailed description: This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.

Eligibility criteria: Inclusion Criteria:

1. Willing to sign the informed consent, and willing to attend follow-up visits.
2. Age ≥ 50
3. Diagnosis of active CNV secondary to neovascular AMD
4. BCVA ETDRS letters between 5 and 63
5. Subjects must have received a minimum of 2 injections within 6 months prior to screening
6. Demonstrated a meaningful response to anti-VEGF therapy

Exclusion Criteria:

1. CNV or macular edema in the study eye secondary to diseases other than nAMD
2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
5. Uncontrolled diabetes defined as HbA1c \>7.5%

Primary outcomes:
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: 4 weeks
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: 52 weeks
Secondary outcomes:
measure: Mean change in BCVA from Baseline
timeFrame: 12 weeks, 36 weeks 52 weeks
measure: Mean change in Central Subfield Thickness (CST) from Baseline
timeFrame: 12 weeks, 36 weeks 52 weeks
measure: Mean time from LX102 administration to anti-VEGF rescue injection for the first time
timeFrame: 52 weeks
measure: Percentage of participants requiring anti-VEGF rescue injection
timeFrame: 52 weeks
measure: Mean number of anti-VEGF rescue injections
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Hangzhou
country: China
facility: Zhejiang University Eye Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai General Hospital
Study officials:
References:
Clinical trial NCT02441413: Transplant Optimization Using Functional Imaging (TROFI)
Official title: Transplant Optimization Using Functional Imaging (TROFI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis Obliterans
Lung Transplant Rejection
Keywords: HRCT
High Resolution Computed Tomography scans
Functional Respiratory Imaging
FRI
Computed Tomography
CT
Bronchiolitis Obliterans Syndrome
BOS
Lung Transplant
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to detect Bronchiolitis Obliterans Syndrome (BOS) in an early stage using the outcome parameters generated by Functional Respiratory Imaging (FRI). Robust and automated segmentation algorithms will be developed for these parameters, focusing on quantitative computed tomography (CT) image analyses to provide the physician a more sensitive diagnostics tool. The evolution of BOS over time will be monitored using nmon-rigid image registration methods.


Eligibility criteria: Inclusion Criteria:

* Male or female patient ≥ 18 years old
* Written informed consent obtained
* Patient who had undergone a lung transplant a year ago or more
* Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before screening visit and will continue to use a contraception method during the study
* The patient must be able to perform the lung monitoring at home
* Patients diagnosed with BOS 0, BOS 0-p or BOS 1

Exclusion Criteria:

* Pregnant or lactating female
* Known history of or active airways or anastomotic complications requiring intervention such as stenting or dilation

Primary outcomes:
measure: Airway Volume (iVaw) using FRI
timeFrame: 12 months
measure: Airway Resistance (iRaw) using FRI
timeFrame: 12 months
measure: Specific Airway Volume (siVaw) using FRI
timeFrame: 12 months
measure: Specific Airway Resistance (siRaw) using FRI
timeFrame: 12 months
measure: Lobe Volumes (iVlobes) using FRI
timeFrame: 12 months
measure: Air Trapping using FRI
timeFrame: 12 months
measure: Internal Lobar Airflow Distribution using FRI
timeFrame: 12 months
measure: Low attenuation or Emphysema Score using FRI
timeFrame: 12 months
measure: Blood Vessel Density or Fibrosis Score using FRI
timeFrame: 12 months
measure: Airway Wall Thickness using FRI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital of Antwerp
name: Wilfried De Backer, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04789213: Mortality, Morbidity and Risk Factors of Liver Retransplantation
Official title: Comparison of Mortality, Morbidity and Risk Factors in Living- Donor and Deceased-Donor Liver Retransplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Liver Transplant Rejection
Liver Transplant Failure
Liver Diseases
Liver Cirrhosis
Liver Failure
Organ Transplant Failure or Rejection
Lead sponsor: Memorial Bahçelievler Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 32
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with liver failure who underwent a second liver transplantation (i.e. re-transplantation)

Brief summary: This study aims to compare the short and long term outcomes of living donor and deceased donor liver retransplantation. Bearing that in mind, the investigators will retrospectively analyze the files of patients whom underwent a liver retransplantation in Memorial Bahcelievler Hospital Organ Transplantation Center.


Eligibility criteria: Inclusion Criteria:

* Having a liver retransplantation

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Survival ratio
timeFrame: 1 minutes
Secondary outcomes:
measure: Morbidity
timeFrame: 10 minutes
measure: Peri-operative informations
timeFrame: 15 minutes
measure: Blood Test Results
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Memorial Bahçelievler Hospital
Study officials:
affiliation: Memorial Bahçelievler Hospital
name: Kamil Yalçın Polat, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156713: Constraint Induced Movement Therapy Summer Camp
Official title: Constraint Induced Movement Therapy Summer Camp for Children With Unilateral Cerebral Palsy Ages 3-7
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Cerebral Palsy, Diplegic, Infantile
Keywords: Hemiparesis
Occupational Therapy
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2014-06-05
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Constraint induced movement therapy (CIMT) is an intervention for unilateral cerebral palsy (CP). It is currently part of standard of care for children with unilateral CP, but is typically done one-on-one and with the child wearing a cast 24 hours a day during the duration of treatment. The purpose of this study is to assess the effects of an intensive group-based CIMT summer camp in which participants wear a removable cast on upper extremity function, occupational performance, and patient-specific goals. The investigators hypothesize that upper extremity skills and occupational performance will increase, and that patients will reach their individualized goals.


Eligibility criteria: Inclusion Criteria:

* Scores of level I, II or III on the Manual Ability Classification System
* Independent grasp
* Ability to ambulate independently or with an assistive device
* Sufficient cooperation and cognitive understanding to participate in a group.

Exclusion Criteria:

* Lack of hand function
* Fixed contractures
* Active seizures
* High tone
* Medical instability
* Non-English speaking parents.

Primary outcomes:
measure: Change in Canadian Occupational Performance Measure Score
timeFrame: Week 5
measure: Goal Attainment Scaling
timeFrame: Week 5
measure: Change in Manual Ability Classification System Level
timeFrame: Week 5
measure: Change in Pediatric Motor Activity Log Score
timeFrame: Week 5
measure: Change in Quality of Upper Extremity Skills Test Score
timeFrame: Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Kelly J Tanner, MOT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05842213: Comparative, Multicenter Study in Subjects with Rheumatoid Arthritis, ALVOFLEX
Official title: Randomized, Double-blind, 2-arm Multicenter Study to Investigate the Efficacy, Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Subjects with Moderate to Severe Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Alvotech Swiss AG
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA).

The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with active RA according to ACR/EULAR 2010 classification criteria
* Subjects diagnosed with moderately to severe active RA as defined by ≥ 6 swollen (out of 66) and ≥6 tender (out of 68) joint counts, CRP \>1mg/l and with at least one of positive rheumatoid factor, positive anti-citrullinated peptide antibodies and/or evidence of 1 joint erosion of hands, wrist of dominant hand or feet at screening
* Subjects must have taken methotrexate for ≥12 weeks

Exclusion Criteria:

* Prior treatment with biologics or Janus kinase inhibitors that may be used as disease-modifying anti-rheumatic drugs
* Any past or concurrent medical conditions that could potentially increase the subject's risks or that would interfere with the study evaluation, procedures or study completion
* Major chronic inflammatory disease or connective tissue disease other than RA or any active autoimmune disease
* Presence of chronic obstructive pulmonary disease
* Presence of chronic heart failure NYHA class III or IV

Primary outcomes:
measure: Demonstrate comparative efficacy of AVT05 with EU-approved Simponi as measured by DAS28-CRP at week 16.
timeFrame: Week 16
Secondary outcomes:
measure: Assess additional efficacy measures of AVT05 and EU-Simponi in terms of DAS28-CRP
timeFrame: Weeks 4, 8, 12, 24, 32, 40, 48 and 52
measure: Assess additional efficacy measures of AVT05 and EU-Simponi in terms of ACR20/50/70 and its individual components throughout the study
timeFrame: Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52
Other outcomes:
Locations:
city: Plovdiv
country: Bulgaria
facility: Rheumatology clinic, University Multiprofile Hospital for Active Treatment Kaspela
Study officials:
affiliation: Alvotech Swiss AG
name: Richard Bucknall
role: STUDY_DIRECTOR
References:
Clinical trial NCT06516913: A Study of Subcutaneous Injection in Healthy Participants
Official title: A Randomized, Participant-Blinded Study to Investigate the Effects of Subcutaneous Injection Volume, Injection Rate, and Needle Length on Pain in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-07-24
Enrollment: 32
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this exploratory study is to learn about the effects of subcutaneous injections on healthy participants.

The study aims to explore how different delivery methods containing a solution impacts injection pain, without an active drug to complicate the results.

Pain assessments will be performed visually and at the injection site to determine the level of pain experienced after each injection.

This study will last approximately 40 days, including screening, assessment, and follow-up.


Eligibility criteria: Inclusion Criteria:

* Are healthy as determined by medical evaluation including medical history and physical examination
* Have a waist circumference, measured around umbilicus, of at least 78 centimeters (cm) for participants assigned male at birth, and at least 71 cm for participants assigned female at birth
* Have a BMI within the range of 21.0 to 30.0 kilograms per square meter (kg/m²)
* Participants assigned female at birth must be of non-childbearing potential and must test negative for pregnancy prior to injection on Day 1

Exclusion Criteria:

* Have known allergies to hyaluronic acid, related compounds, or any components of the formulation, or history of significant atopy. Components of the formulation include, but are not limited to, sodium hyaluronate, sodium chloride, and sodium phosphate
* Have a history of severe injection-site reactions
* Have current or previous history of anaphylaxis
* Have tattoos or scars over the abdomen, or other factors, for example excessive folds of skin, that, in the investigator's opinion, would interfere with injection site assessments
* Have self-perceived dullness or loss of sensation on either side of the body and the abdomen
* Have a history or presence of a bleeding, wound healing (including diabetes), or fibrotic disorder
* Have known or ongoing psychiatric disorders

Primary outcomes:
measure: Visual analogue scale (VAS) Pain score at Injection Site
timeFrame: Needle insertion to 240 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Fortrea CRU, Inc.
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06812013: Impact of Idiopathic Scoliosis on Balance and Footprint Symmetry in Adolescents
Official title: Impact of Idiopathic Scoliosis on Balance and Footprint Symmetry in Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scoliosis Idiopathic
Keywords: foot print
scoliosis
balance
Lead sponsor: Al-Zaytoonah University of Jordan
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 150
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population \& Sample size: One hundred and fifty adolescents will be recruited to participate in the study, seventy-five of them will be healthy adolescents while the other Seventy-five adolescents will have idiopathic scoliosis with different degrees of scoliosis curves.

Brief summary: Adolescent idiopathic scoliosis (AIS) is the most prevalent form of scoliosis that affects children after the age of 10 years and is considered a critical developmental stage of the musculoskeletal system of the child. AIS causes deviations in the CNS, leading to asymmetry of motor activity and, consequently, an incorrect position of the spine. The progressive deformation of the spine leads to increased asymmetry in body functions. This elevated asymmetry is understood by the nervous system as a norm, which causes children to cease to sense the correct body position that may affect both static and dynamic balance and the foot pressure symmetry of the child, which was not investigated in such cases in any previous studies till now.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic children and adolescents ages 10 to 18 years
* confirmed through X-rays; we focused on patients in growing age.
* adolescent idiopathic scoliosis that has a Cobb angle of 10° to 50°

Exclusion Criteria:

* Neuromuscular etiology (e.g., cerebral palsy, myelomeningocele, muscular dystrophy, spinal muscular atrophy, spina bifida, spinal cord injuries)
* Early-onset idiopathic etiology (infantile \[ages 0 to 3 years\] or juvenile \[ages 4 to 9 years\])
* Congenital etiology (e.g., hemivertebrae, failure of segmentation) Mesenchymal/syndromic etiology (e.g., Marfan syndrome, mucopolysaccharidosis, osteogenesis imperfecta, inflammatory diseases, postoperative)

Primary outcomes:
measure: static and dynamic balance
timeFrame: 2 months
measure: foot print
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Modern University for Technology and Information
Study officials:
References:
Clinical trial NCT01082913: The Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology
Official title: Study of the Effect of Sacral Surface Electrical Stimulation for Assisted Reproductive Technology
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Infertility
Lead sponsor: Shiga University
Sponsor class: OTHER
First posted: 2010-03-09
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether sacral surface electrical stimulation is effective in the treatment of assisted reproductive technology.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of infertility

Primary outcomes:
measure: thickness of myometrium after embryo transfer
timeFrame: 3 years
Secondary outcomes:
measure: implantation rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Ohtsu
country: Japan
facility: Shiga University of Medical Science
state: Shiga
Study officials:
References:
Clinical trial NCT04759313: Image Narrative With College Students
Official title: Image Narrative With College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Keywords: depression
college students
posttraumatic growth
meaning making
quality of life
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The PI developed the Image Narrative Intervention (INI) based on the research using visual images in which visual images and narratives were found to support trauma survivors in narrating their experiences and in meaning making. The proposed study is the first study to test the therapeutic effect of the INI program. The investigators propose to assess, both qualitatively and quantitatively, the feasibility and preliminary effect of the INI through a pilot randomized control trial (RCT) design with a wait list control.

Detailed description: AIM 1. To understand the unique experiences of emerging adult college students during the Covid-19 pandemic (especially around the themes of the self, relationships with others, and the future).

AIM 2. To evaluate the feasibility of the INI for emerging adult college students during the Covid-19 pandemic, both quantitatively and qualitatively.

AIM 3. To evaluate the preliminary efficacy of the INI on distress, PTG, Quality of Life and Meaning-Making.

Eligibility criteria: Inclusion Criteria:

* 18-29 in age
* college students at the University of Utah
* reporting moderate or higher levels of distress in DASS21

Exclusion Criteria:

-

Primary outcomes:
measure: DASS (Depression, Anxiety and Stress Scale) 21
timeFrame: change through study completion, an average of 3 months
measure: PTGI (posttraumatic growth index)
timeFrame: change through study completion, an average of 3 months
measure: WHOQOL (WHO quality of life)-bref
timeFrame: change through study completion, an average of 3 months
measure: MLQ (meaning in life)
timeFrame: change through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jaehee Yi, PhD
role: PRINCIPAL_INVESTIGATOR
References: