louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06420193: Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit
Official title: Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Cancer
Adolescent
Young Adult
Adult
Lead sponsor: East Carolina University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-05-17
Enrollment: 16
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes daily mood tracking, a psychoeducational module about cancer and depression, four components that are based on evidence-based interventions for depression. The goal of this study is to evaluate the acceptability of procedures for a future trial in which the investigators will test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs. Additionally, the investigators will evaluate study feasibility as well as intervention acceptability, satisfaction, usability, and engagement.


Eligibility criteria: Inclusion Criteria:

* Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39)
* Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39)
* Time since completion of treatment: 1 month to 5 years
* Language: Fluent in English (spoken and written)
* Technology: Own smart phone with data plan

Exclusion Criteria:

* Mental Health: Current diagnosis of severe or persistent mental illness
* Suicidality: Severe suicidal ideation (including plan and intent)

Primary outcomes:
measure: Acceptability of Study Procedures - Quantitative
timeFrame: Week 6
measure: Acceptability of Study Procedures - Qualitative
timeFrame: Weeks 6-8
Secondary outcomes:
measure: Study Feasibility - Recruitment Rate
timeFrame: Upon enrollment of 16 participants
measure: Study Feasibility - Retention Rate
timeFrame: Week 6
measure: Intervention Acceptability - Quantitative
timeFrame: Week 6
measure: Intervention Satisfaction - Quantitative
timeFrame: Week 6
measure: Intervention Acceptability & Satisfaction - Qualitative
timeFrame: Weeks 6-8
measure: System Usability Scale
timeFrame: Week 6
measure: Intervention Adherence
timeFrame: Weeks 1-6
measure: eHealth Engagement Scale
timeFrame: Week 6
Other outcomes:
Locations:
city: Greenville
country: United States
facility: East Carolina University
state: North Carolina
Study officials:
affiliation: East Carolina University
name: Karly M Murphy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04403893: Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study
Official title: Feasibility and Safety of a Dedicated Biliary Stent for Transmural EUS-guided Hepatico-gastrostomy: the FIT Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Bilio-pancreatic Diseases
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 20
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: Subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary stent positioning for biliary drainage after ERCP failure.

Brief summary: One of the major roles of interventional EUS is biliary drainage (EUS-BD) as an alternative to ERCP-based biliary decompression.

In fact, even when performed by expert endoscopists, ERCP-based stenting fails in 5% of cases. In these cases, standard alternative approaches include surgical bypass and percutaneous transhepatic cholangiography and biliary drainage (PTBD). However, these procedures are associated with higher patient discomfort and prolonged hospital stay.

The most diffuse approach for EUS-BD are choledochoduodenostomy (CDS) or hepaticogastrostomy (HGS). As a matter of fact, since dedicate devices as lumen apposing metal stents (LAMS), have been adopted for CDS, we have been witnessing the escalation of such procedure.

On the other hand, the diffusion of EUS-HGS is still limited due to the complexity of the procedure and the lack of dedicated devices. However, recently a dedicated stent was conceived as asymmetrically covered and shaped in order to have its uncovered, tubular end into the intrahepatic ducts and the covered, flanged end into the gastric cavity, to reduce the risk of migration. The developement of such stent could further increase both the technical feasibility and the clinical outcomes of HGS in order to explore the whole potential of this procedure and to definitively find its role in biliary drainage algorithm.


Eligibility criteria: Inclusion Criteria:

• subjects with malignant bilio-pancreatic diseases with an indication to undergo biliary stent positioning for biliary drainage after ERCP failure.

Exclusion Criteria:

* Age \< 18 y
* Contra-indication for endoscopy or interventional radiology
* Unsigned informing consent form, ICF
* Pregnancy

Primary outcomes:
measure: AE and SAE events
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT05772793: Telerehabilitation for Visually Impaired
Official title: Usability and Adherence of Visually Impaired to Telerehabilitation: a Multicentre Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Impairment
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients were eligible if they were over 18 years old and had a best corrected visual acuity (BCVA) between 1.3 logMAR and 0.4 LogMAR and/or a visual field of less than 60%, according to the WHO classification.

Brief summary: the purpose of the study is to evaluate the software usability and patient's adherence from five vision rehabilitation centres. In addition, the effect and benefits of a customizable telerehabilitation program were tested.

Detailed description: The software is used in our practice for every day vision rehabilitation training.

So it is part of our routine medical care, and a we are going to study studies the effect of the intervention in several different centers.

Eligibility criteria: Inclusion Criteria:

* All patients were eligible if they were over 18 years old and had a best corrected visual acuity (BCVA) between 1.3 logMAR and 0.4 LogMAR and/or a visual field of less than 60%, according to the WHO classification.

Exclusion Criteria:

* Subjects were excluded if they had a cognitive/psychiatric impairment or a motor disability that prevents the use of a computer pointing device (mouse).

Primary outcomes:
measure: Utility of EyeFitness telerehabilitation
timeFrame: 6 months
Secondary outcomes:
measure: Effect of treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study officials:
References:
Clinical trial NCT05835193: Pre-symptomatic Screening of Visual Acuity in Pre-school Students
Official title: Visual Acuity Assessment in Pre-school Students.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Acuity
Refractive Errors
Low Vision
Vision Disorders
Keywords: kindergarten
distance visual acuity
pre-school students
reading capacity
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 1098
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-school students aged 5-7 years old

Brief summary: The present research process is a prospective, non-interventional clinical study that will be conducted -under the auspices of the Democritus University of Thrace (DUTH)- in the pre-school students of the city of Alexandroupolis, Greece.

* The study aims to assess the visual acuity of the kindergarten students.
* The measurement of monocular best-spectacle corrected visual acuity will be performed using a web-based visual acuity chart

Detailed description: Study protocol will adhere to the tenets of the Declaration of Helsinki and written informed consent will be obtained by the legal guardians of all participants.

The measurement of the visual acuity (monocular and binocular) will be performed using DDART, a digital visual acuity tool that has been developed and validated by the Democritus University of Thrace and is also an approved Category 1 Medical Device by the country's National Organization for Medicines, via a web-based digital chart in a high-resolution screen. The same environmental lighting conditions and the same screen brightness will be applied. The examination will be performed at the same predetermined viewing distance.

Finally, according to each participant's visual acuity, appropriate instructions will be given for further examinations directly to the legal guardians in order to comply with the GDPR.

Eligibility criteria: Inclusion Criteria:

* Pre-school students aged 5-7 years old.

Exclusion Criteria:

* Age \>7 years old
* Students with health conditions that do not allow the evaluation of the visual acuity .

Primary outcomes:
measure: Best spectacle-corrected distance visual acuity
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00939913: Effect of Intravenous Acetadote on Incidence of Contrast Induced Nephropathy
Official title: N-Acetylcysteine to Prevent Contrast-Induced Nephropathy in Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Nephropathy
Keywords: contrast nephropathy
intravenous n-acetlycysteine
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
Collaborators: name: Cumberland Pharmaceuticals
First posted: 2009-07-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In patients undergoing coronary angiography, the incidence of contrast induced nephropathy(CIN)varies widely and ranges from \< 5% in the lowest risk patients, to nearly 50% in the highest risk patients. Prior data has shown oral n-acetyl cysteine (NAC) to be effective in reducing the incidence of CIN.Due to extensive first pass metabolism, the bioavailability of oral NAC is poor and ranges from 4%-10%. We hypothesize that the incidence of CIN will be reduced in patients with ACS who undergo PCI by the prophylactic administration of intravenous NAC.

This is a prospective, randomized, double-blind, placebo-controlled single center clinical trial designed to evaluate the effects of intravenous NAC on patients with acute coronary syndromes (ACS)undergoing coronary angiography and/or percutaneous coronary intervention (PCI). The medication Acetadote is provided by Cumberland Pharmaceuticals Inc (www.cumberlandpharma.com).

Patients will be excluded if they have end-stage renal disease requiring dialysis,known hypersensitivity to NAC or a history of life-threatening contrast reaction. Primary end-point is incidence of CIN. Secondary end-points are in-hospital mortality,30-day mortality,duration of hospitalization and change in serum cystatin C level.


Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older.
2. Hospitalized with a primary diagnosis of acute coronary syndrome.
3. Scheduled for coronary angiography or intervention during the current hospitalization.

Exclusion Criteria:

1. Have end-stage renal disease (ESRD) requiring dialysis.
2. Have a known hypersensitivity to NAC.
3. Have a history of life-threatening contrast reaction. -

Primary outcomes:
measure: Incidence of CIN
timeFrame: 48-72 hours
Secondary outcomes:
measure: in-hospital mortality
timeFrame: 30 days
measure: 30 day mortality
timeFrame: 30 days
measure: duration of hospitalization
timeFrame: 30 days
measure: serum cystatin C
timeFrame: 48-72 hours
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
References:
citation: Jaffery Z, Verma A, White CJ, Grant AG, Collins TJ, Grise MA, Jenkins JS, McMullan PW, Patel RA, Reilly JP, Thornton SN, Ramee SR. A randomized trial of intravenous n-acetylcysteine to prevent contrast induced nephropathy in acute coronary syndromes. Catheter Cardiovasc Interv. 2012 May 1;79(6):921-6. doi: 10.1002/ccd.23157. Epub 2011 Nov 30.
Clinical trial NCT02966613: Fully Disposable Patient-Specific Instrumentation
Official title: Primary TKA Using a Fully Disposable Patient-Specific Instrumentation: A Multicenter Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis,Knee
Lead sponsor: Cochin Hospital, India
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the lower limb alignment following total knee arthroplasty (TKA) performed with fully disposable patient-specific instrumentation versus conventional, versus patient specific instrumentation.

Detailed description: The investigators performed a controlled multicenter trial comparing the clinical and radiologic results and resources consumption of primary TKA using patient-specific cutting guides (PSCG) versus conventional instrumentation (CI), and compared the results to those obtained with a fully disposable patient-specific instrumentation (PSCG-D).

Eligibility criteria: Inclusion Criteria:

* patients aged between 18 and 85 years
* able to understand information
* affiliated to social security

Exclusion Criteria:

* active or suspected sepsis
* tumor around the knee
* previous partial or total knee replacement
* extra-articular deformation requiring osteotomy around the knee in conjunction with TKA
* social situation that could impair follow-up

Primary outcomes:
measure: HKA angle
timeFrame: 3 months
Secondary outcomes:
measure: % outliers
timeFrame: 3 months
measure: Knee Society Score
timeFrame: 3 months
measure: Oxford Knee Score
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
citation: Abane L, Zaoui A, Anract P, Lefevre N, Herman S, Hamadouche M. Can a Single-Use and Patient-Specific Instrumentation Be Reliably Used in Primary Total Knee Arthroplasty? A Multicenter Controlled Study. J Arthroplasty. 2018 Jul;33(7):2111-2118. doi: 10.1016/j.arth.2018.02.038. Epub 2018 Feb 17.
Clinical trial NCT06710613: Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort Study
Official title: Efficacy of High-flow Nasal Oxygen in Preventing Hypoxia During Gastrointestinal Endoscopy: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypoxia
Keywords: High flow nasal cannula oxygen
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who underwent painless gastroscopy

Brief summary: During painless gastroscopy, the occurrence of hypoxia is a critical concern, especially under intravenous anesthesia using propofol. This study aimed to investigate the incidence of hypoxia during painless gastroscopy and evaluate preventive measures.

Detailed description: From June 15 th 2023 to August 15th 2023, 900 patients who underwent elective gastroscopy in the Renji Hospital, Shanghai Jiao Tong University School of Medicine were selected. They were divided into the high flow nasal cannula oxygen group and the conventional nasal cannula oxygen group by oxygen inhalation. Patient demographics, Mallampati class, and other relevant factors were compared between the two groups. Primary outcomes included the incidence hypoxia (SpO2 \< 90%), while secondary outcomes included subclinical respiratory depression, and adverse events related to nasal oxygen cannula.

Eligibility criteria: Inclusion Criteria：

* Patients aged 18 to 70
* Undergoing painless gastroscopy under intravenous anesthesia

Exclusion Criteria：

* Severe respiratory disease
* History of nasal bleeding or mucosal injury
* Emergency cases
* Pregnant or lactating female

Primary outcomes:
measure: incidence of hypoxia
timeFrame: 60 seconds
Secondary outcomes:
measure: the incidence of subclinical respiratory depression and adverse events
timeFrame: 30 minute
Other outcomes:
Locations:
city: Nanchang
country: China
facility: Nanchang University
state: Jiangxi
Study officials:
affiliation: Nanchang University
name: Fengli Liu, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03174613: A Study To Evaluate The Safety, Pharmacokinetics/Pharmacodynamics (PK/PD) and Food Effect Of LC51-0255
Official title: A Dose Blocked-randomized, Double-blind, Placebo Controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamics and Food Effect of LC51-0255
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: LG Chem
Sponsor class: INDUSTRY
First posted: 2017-06-02
Enrollment: 100
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 1. To evaluate the safety and tolerability of LC51-0255 in healthy male subjects
2. To evaluate the pharmacokinetic/pharmacodynamics characteristics (PK/PD) of LC51-0255 in healthy male subjects
3. To evaluate bioavailability of LC51-0255

Detailed description: For safety and tolerability assessement, subjects will be monitored by collection of adverse events, physical exams, vital sign, 12-Lead ECG, Continuous ECG monitoring, Holter monitoring, blood chemistry and hematology panels, pulmonary function tests, optical coherence tomography (OCT) during the study.

Eligibility criteria: Inclusion Criteria:

* Healthy male subjects aged 19\~45 years at screening.
* Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive)

Exclusion Criteria:

* History or Known presence of clinically relevant hepatic, gastrointestinal, pulmonary, psychiatric, endocrine, neurological, cancer, including solid tumors and hematological malignancies, cardiovascular, ophthalmological or other major systemic disease
* Exclusions Related to Laboratory Results: Platelet count \< 100,000/μL, Hgb \< 8.5 g/dL, Neutrophils \< 1.5 /μL, Absolute WBC count \< 3500/μL, Absolute lymphocyte count \< 800/μL

Primary outcomes:
measure: MTD determination
timeFrame: Dose limiting Toxicity will be evaluated at Day 19 in Single dosing study and at Day 39 in Multiple dosing study
Secondary outcomes:
measure: Pharmacokinetic: Peak Plasma Concentration (Cmax)
timeFrame: Cmax:168 hours post dose
measure: Pharmacokinetic: Area under the plasma concentration versus time curve (AUC)
timeFrame: AUCinf:168 hours post dose
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital, Clinical Trial Center
name: Kyung-Sang Yu, MD,M.B.A.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02072213: A PK Study GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
Official title: A Randomized, Open-label, Single-dose, Four-sequence, Four -Period Crossover Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Tamsulosin,controlled release formulation
Lead sponsor: GL Pharm Tech Corporation
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Study to Investigate The Pharmacokinetics of GL2702 GLARS-NF1 and Omix Ocas® in Healthy Male Volunteers

Detailed description: GL2702 GLARS-NF1 tablet is controlled released formulation which is invented by GL Pharm Tech Corp.

Eligibility criteria: Inclusion Criteria:

* 20\~45 years old, Healthy Adult Male Subject
* Body Weight ≥ 50kg and Ideal Body Weight ≤ ±20%

Exclusion Criteria:

* ALT or AST \> 1.25 times (Upper Normal Range)
* Total Bilirubin \> 1.5 times (Upper Normal Range)
* CPK \> 2 times (Upper Normal Range)
* BUN or Creatinine \> Normal Range
* Systolic BP \> 160mmHg or \< 80mmHg, Diastolic BP \> 100mmHg or \< 50mmHg

Primary outcomes:
measure: Cmax
timeFrame: 48 hours
measure: AUClast
timeFrame: 48 hours
Secondary outcomes:
measure: Tmax
timeFrame: 48 hours
measure: t1/2
timeFrame: 48 hours
measure: Vz/F
timeFrame: 48 hours
measure: CL/F
timeFrame: 48 hours
Other outcomes:
Locations:
city: Jeonju-si
country: Korea, Republic of
facility: Chonbuk National University Hospital
state: Jeollabukdo
Study officials:
affiliation: Chonbuk National University Hospital
name: Min-Gul Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: