louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03980834: Teachers Thriving Together
Official title: Teachers Thriving Together
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Emotional Competence
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, controlled, hybrid implementation-effectiveness design.whose primary aim is to examine the impact of ParentCorps plus Thrive Professional Learning, relative to Thrive Professional Learning and Inspire Professional Learning alone, on teachers' classroom teaching (knowledge, beliefs, skills and practice related to family engagement and social emotional learning) and teachers' social emotional development. The study also aims to understand the impact of Thrive Professional Learning versus Inspire Professional Learning alone on teachers and classrooms.


Eligibility criteria: Inclusion Criteria:

* The participants are lead teachers, assistant teachers, teaching assistants, paraprofessionals and teacher aides in 238 sites with Pre-K in NYC (for the purposes of this study, the term "teachers" will be used to represent this group). The inclusion criteria include teachers who participate in Thrive or Inspire Professional Learning in 2018-2019. Additionally, 449 teachers from 81 district schools (that are part of the Thrive and Inspire Professional Learning) are were randomized into the study will participate.
* To be eligible for the study, sites met the following criteria: a) have 2 or more PKFA classrooms; b) serve a high-need population and c) leaders ranked Thrive or Inspire as a first or second preference for the school. "High need" was defined as follows: the site level percentage of students in poverty was above the median of the eligible pool; the site level percentage of students in poverty was in the second quartile of the eligible pool and two or more students were listed as living in temporary housing; and/or the site level percentage of students in poverty was in the first quartile of the eligible pool and 5 or more students were listed as living in temporary housing.

Exclusion Criteria:

* Sites that were currently implementing ParentCorps at the time of the randomization were not eligible for the study. Only teachers who were part of the Thrive or Inspire Professional Learning tracks in 2018-2019 will be eligible.

Primary outcomes:
measure: Emotion Regulation Questionnaire-Modified (ERQ)
timeFrame: 1 Year
measure: Panorama Teacher and Staff Survey
timeFrame: 1 Year
measure: Mindfulness in Teaching Scale-Modified
timeFrame: 1 Year
measure: Parental Engagement of Families from Latino Backgrounds Questionnaire-Modified [PEFL- English]
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Laurie Brotman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05960734: Artificial Intelligence in Healthcare: Advanced Evaluation of Medical Online Content. AI-driven Quality Assessment of YouTube Videos Providing Information on Incontinence After Cancer Surgery.
Official title: Artificial Intelligence in Healthcare: Advanced Evaluation of Medical Online Content. Assessment of Health Knowledge and Related Educational Intervention.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Incontinence
Patient Education
Social Networks
Surgery
Keywords: Cancer
Incontinence
Patient Education
Social Networks
Surgery
Youtube
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 160 samples providing information about incontinence after cancer surgery.

Brief summary: The aim of the study is to analyse the quality of information that patients and relatives of different types of cancer receive through social networks on the subject of incontinence after cancer surgery.

Detailed description: The primary goal of this study is to meticulously analyze and evaluate the overall quality of information that patients and their relatives obtain through social networks. The specific focus of the investigation lies in exploring the subject of incontinence after cancer surgery, encompassing a diverse range of cancer types. By closely examining the information disseminated across various social platforms, the researchers aim to shed light on the accuracy, reliability, and comprehensiveness of the information available. Ultimately, this study seeks to enhance our understanding of the information landscape surrounding post-cancer surgery incontinence, empowering patients and their relatives to make well-informed decisions regarding their healthcare.

Eligibility criteria: Inclusion Criteria:

* Anyone providing information about incontinence after cancer surgery.
* English language

Exclusion Criteria:

* Non-english language
* Duplicated
* Related with advertisements
* Nonrelated to incontinence

Primary outcomes:
measure: Analisys of the information in social networks about incontinence after cancer surgery
timeFrame: 2023-2024
Secondary outcomes:
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: University of Oviedo
state: Asturias
Study officials:
affiliation: University of Oviedo
name: Maria Blanco-Diaz, Prof. PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05994534: PK and PD Study of NPI-001 and Cysteamine Bitartrate
Official title: A Phase 1/2 Pharmacokinetic and Pharmacodynamic Study of NPI-001 Oral Solution Compared to Cysteamine Bitartrate in Cystinosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cystinosis
Lead sponsor: Nacuity Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-16
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients compared with cysteamine.

Detailed description: This study will examine the safety, pharmacokinetics, and pharmacodynamics of NPI-001 oral solution in cystinosis patients, aged ≥ 10 years. The ability of NPI-001 to reduce cystine will be assessed and compared with cysteamine.

Eligibility criteria: Inclusion Criteria:

1. Males or females, any race, ≥ 10 years of age.
2. Diagnosis of nephropathic cystinosis and able to cease cysteamine therapy for 2 days.
3. Females will be nonpregnant and nonlactating, and females of childbearing potential and males will agree to use contraception as detailed in the protocol.
4. Able to comprehend and willing to sign an informed consent /assent form and to abide by the study restrictions (travel as necessary, clinical phase 1 unit or similar for up to 3 days).

Exclusion Criteria:

1. Have undergone kidney transplantation.
2. Are receiving dialysis treatment.
3. History of significant hypersensitivity to NAC or any ingredient of NPI-001 oral solution.
4. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the 30 days prior to Day 1.
5. Inability to provide blood samples, including difficulty with venous access.
6. Subjects who, in the opinion of the Investigator and/or Sponsor (or designee), should not participate in this study.

Primary outcomes:
measure: Concentration of Cystine Levels Over Time
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Westmead
country: Australia
facility: Children's Hospital at Westmead
state: New South Wales
Study officials:
affiliation: Sydney Children's Health Network
name: Hugh McCarthy, PhD, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04454034: Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis
Official title: Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis of Ankle
Keywords: Rheumatoid Arthritis
Arthroscopic Synovectomy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who fullfill the Eligibility Criteria

Brief summary: Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is an important method to save the function of joint in the treatment of refractory RA. The clinical trial is to study the value of AS combine with DMARDs in the early stage of refractory RA.


Eligibility criteria: Inclusion Criteria:

* The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010 ACR/EULAR（European League Against Rheumatism） RA classification criteria.
* The age is more than 18 years old and less than 60 years old.
* They received stable traditional DMARDs (including Chrysopidae, leflunomide, sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal antibodies) for at least 6 months.
* The disease is still in the active stage, which means the disease activity score (DAS28) is more than 3.2, and the elbow joint function is obviously limited.
* The patient agreed to undergo arthroscopic synovectomy.
* No contraindications were found.

Exclusion Criteria:

* The disease is in remission.
* The patient has contraindications.
* Arthroscopic synovectomy was performed in different patients.

Primary outcomes:
measure: ACR70 remission
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)
timeFrame: 1,3,6 and 12 months after surgery
measure: tender joint count
timeFrame: 1,3,6 and 12 months after surgery
measure: swollen joint count
timeFrame: 1,3,6 and 12 months after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Univerisity Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03932734: Patient Satisfaction After Patient-specific Jawline Augmentation
Official title: Patient Satisfaction After Patient-specific Jawline Augmentation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Deformity of Face
Post-traumatic Deformity
Keywords: Satisfaction
Jawline augmentation
Transgender
Cosmetic jaw angle
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2019-05-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who had lower jaw augmentation implants since 2014 not gender based

Brief summary: The survey studies patient satisfaction after titanium patient specific jawline augmentation in congenital, post-trauma, deformity and transgender/cosmetic jaw angle/border deficiencies.

Detailed description: Additively manufactured titanium implants have been pre-designed in the hospital department, further designed and manufactured by 2 Belgian companies. The issue is if all patients have satisfactory perception of the improvement of their morphology and the actual outcome of the procedure, and how theur social ineractions are perceived today.

Eligibility criteria: Inclusion Criteria:

- All lower jaw augmentation implants

Exclusion Criteria:

- N/A

Primary outcomes:
measure: Satisfaction/Quality of Life
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Maurice Mommaerts, Prof Mult
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00268034: Left Ventricular Aneurysms in Children
Official title: Left Ventricular Aneurysms in Children
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Congenital Disorders
Keywords: pediatric
cardiac
aneurysms
left ventricular aneurysms
surgical repair for LV aneurysms
Lead sponsor: Children's Healthcare of Atlanta
Sponsor class: OTHER
First posted: 2005-12-22
Enrollment: 5
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Collect data to support "standard of care possibility" of extracardiac repair with closure of intracavitary communication and plication of the aneurysm as probably safest surgical repair for left ventricular aneurysms.

Detailed description: Ventricular aneurysms in the pediatric population are rare and no standardized method of treatment exists.

We plan on reviewing five patient charts between the dates of 6.30.02 and 6.30.04 as to causes of aneurysms. The patient charts selected will be in the following "aneurysm categories":

Mostly occur after:

Ross/Ross-Konno procedures modified Rastelli-type interventricular tunnels repeated resections of subaortic stenosis and possibly after: myocardial ischemia trauma drainage of abscess in infective endocarditis progressive herniation of endocardium mostly located: in LV outflow tract

We plan on collecting echocardiograms and / or cardiac catheterizations data in order to confirm the diagnosis of an aneurysm. We will also collect the following information:

* Procedures including the dates performed
* Medications
* Physical Exam Findings
* Weight
* Gestational Age
* Outcome

Eligibility criteria: Inclusion Criteria:

* aneurysms between 6.30.2002 and 6.30.2004

Exclusion Criteria:

* those children who do no meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
Study officials:
affiliation: Children's Healthcare of Atlanta
name: Kirk R Kanter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02999516: Complex Motor Learning With Motor Imaginary
Official title: Complex Motor Learning With Motor Imaginary
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Learning Disturbance
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects participate in a motor learning training with a special bicycle. The experimental group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest where they use motor imaginary. The control group proceed equal except for the motor imaginary intervention.

Detailed description: Subjects participate in a motor learning training with a special bicycle. The experimental group proceed with 15 minutes of physical training with the bicycle and 15 minutes of rest where they use motor imaginary. The control group proceed equal except for the motor imaginary intervention.

Participants will be controlled for vestibular system previous participation.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 29 years old
* Asymptomatic

Exclusion Criteria:

* Subjects with pain
* In medical treatment
* Diagnosed of any disease

Primary outcomes:
measure: Time
timeFrame: immediately during the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Centro Superior de Estudios Universitarios La Salle
Study officials:
References:
citation: Serrano JI, Munoz-Garcia D, Ferrer-Pena R, D'eudeville V, Brero M, Boisson M, Del Castillo MD. Prior cortical activity differences during an action observation plus motor imagery task related to motor adaptation performance of a coordinated multi-limb complex task. Cogn Neurodyn. 2020 Dec;14(6):769-779. doi: 10.1007/s11571-020-09633-2. Epub 2020 Sep 10.
Clinical trial NCT05321316: Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
Official title: Nectin-4 Specific LMW PET Probe Imaging in Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urothelial Carcinoma
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To evaluate the ability of \[68Ga\]N188 to detect nectin-4 overexpression in patients with urothelial carcinoma, especially in patients with recurrent or advanced bladder cancer.


Eligibility criteria: Inclusion Criteria:

1. 18-75 years old, male or female;
2. Heart function is normal;
3. Normal heart function;
4. Estimated survival ≥12 weeks;
5. Good follow-up compliance;
6. presence of at least one measurable target lesion according to RECIST1.1 criteria;
7. Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting the test; Fertile men and women must agree to use effective contraception to prevent pregnancy during the study period and for 3 months after the test;
8. Patients recommended by clinicians to undergo PET/CT examination for tumor diagnostic staging;
9. The subject patients could fully understand and voluntarily participate in the experiment, and signed the informed consent.

Exclusion Criteria:

1. Serious abnormality of liver, kidney and blood;
2. Pregnant patients;
3. Pregnant and lactation women;

3) unable to lie flat for half an hour; 4) Refuse to join the clinical investigator; 5) Suffering from claustrophobia or other mental diseases; 6) Other conditions that researchers deem unsuitable for participating in the experiment.

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02985216: Clinical Trial of YHD1119 in Patients With Peripheral Neuropathic Pain
Official title: A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy Between YHD1119 and Pregabalin in Patients With Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Neuropathic Pain
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2016-12-07
Enrollment: 371
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic Pain


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* HbA1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in Diabetic Peripheral Neuropathy or postherpetic Neuralgia patients at least 3 months pain after diagnosis of skin rash due to herpes zooster

Exclusion Criteria:

* Have Brittle diabetes mellitus

Primary outcomes:
measure: Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
timeFrame: Baseline, Day 85
Secondary outcomes:
measure: Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
timeFrame: Day 1, 8, 15, 22, 29, 57, 85
measure: Mean Pain Score on the Daily Pain Rating Scale at each visit
timeFrame: Day 1, 8, 15, 22, 29, 57, 85
measure: Patients proportion of reduction over 30% in Mean Pain Score from Baseline
timeFrame: Day 1, 8, 15, 22, 29, 57, 85
measure: Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)
timeFrame: Day 1, 8, 15, 22, 29, 57, 85
measure: Patient Global Impression of Change (PGIC)
timeFrame: Day 85
measure: Clinical Global Impression of Change (CGIC)
timeFrame: Day 85
measure: SF-12 (Short form-12)
timeFrame: Baseline, Day 85
measure: C-SSRS (Columbia Suicide Severity Rating Scale)
timeFrame: Baseline, Day 8, 29, 85
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yong Chul Kim
Study officials:
affiliation: Seoul National University
name: Yong Chul KIM, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02406716: Semaphorins 3A and 4D Levels in Heart Failure Patients
Official title: Semaphorins 3A and 4D Levels in Heart Failure Patients: Pathogenesis and Clinical Correlation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-04-02
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with new onset or previously diagnosed heart failure

Brief summary: This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with heart failure. Study protocol:

Hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. Control group will include healthy people with no medical records or chronic treatment at the same age range. After signing an informed constent form, full medical history and blood samples will be collected. A second blood sample will be collected 8 weeks later, assuming the patient was discharged and not hospitalized since than. The blood samples will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels in the heart failure group and control group. Statistical analysis will then commence for possible correlatoion with different clinical parameters.

Detailed description: In few previous published studies, Semaphorins 3A levels are overexpressed in patients with heart failure. The aim of our study is the compare semaphorin 3A and 4D in patients with acute decompansated heart failure with healthy donors. Second aim is to compare semaphorin level in the same patients in time of hospitalization and few weeks later when the heart failure presumingly controled. Statistical analysis will then commense for possible correlatoion with different clinical parameters like NYHA (new york heart association) status of the patient, lenghts of hospitalization and BNP (brain natriuretic peptide) levels at time of admition.

Eligibility criteria: Inclusion Criteria:

* Patients with new onset or previously diagnosed heart failure.
* Heart failure diagnosis can be based on clinical judgment, echocardiography or elevated BNP levels

Exclusion Criteria:

* Patients with acute myocardial infarction diagnosed clinicly and labratory

Primary outcomes:
measure: Semaphrone 3A and 4D levels
timeFrame: one year
Secondary outcomes:
measure: BNP level
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Bnai Zion Medical Center, Immunology devision
name: Zahava Vadas, MD. PHD.
role: PRINCIPAL_INVESTIGATOR
References: