louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05497271: Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions
Official title: Confirmation of Association Between Cystic Fluid Analysis With Pancreatic Cystic Lesions and Study of Its Application for Diagnosis, Treatment and Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatic Cyst
Molecular, Chemical Analysis of Cystic Fluid
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 500
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 who were diagnosed with pancreatic cystic lesions and managed in Seoul National University Hospital

Brief summary: Through a comprehensive analysis of the pancreatic cystic fluid analysis, the role of the cystic fluid analysis is confirmed in terms of accurate diagnosis of pancreatic cysts, appropriate prediction of treatment response, and to select proper treatment indication through analytic results.


Eligibility criteria: Inclusion Criteria:

1. patients who diagnosed with pancreatic cystic lesion
2. patients who are able to acquire cystic fluid through EUS-FNA or surgery
3. patients aged 18 years and older

Exclusion Criteria:

1. patients who did not want to participate in this study
2. patients aged under 18 years old
3. severely mentally ill patients
4. pregnant women

Primary outcomes:
measure: diagnostic accuracy by cystic fluid analysis
timeFrame: up to 5 years after cystic fluid analysis
Secondary outcomes:
measure: Overall survival
timeFrame: up to 5 years after cystic fluid analysis or surgical resection
measure: Disease free survival
timeFrame: up to 5 years after cystic fluid analysis or surgical resection
measure: Malignant transformation rate
timeFrame: up to 5 years after cystic fluid analysis
measure: Prediction for treatment response in case of surgical resected or EUS-guided ethanol ablated pancreatic cysts
timeFrame: up to 5 years after cystic fluid analysis or EUS guided ablative therapy
measure: Cytology of cystic fluid
timeFrame: within 2 months after study enrollment
measure: Chemical profile of CEA in cystic fluid
timeFrame: within 2 months after study enrollment
measure: Chemical profile of Amylase in cystic fluid
timeFrame: within 2 months after study enrollment
measure: Chemical profile of glucose in cystic fluid
timeFrame: within 2 months after study enrollment
measure: DNA mutation profile of cystic fluid
timeFrame: within 2 months after study enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01244971: Exercise and Acarbose in Type 2 Diabetes
Official title: Effect of Exercise Training - Alone or in Combination With Acarbose - on Clinical and Metabolic Factors, and Studies of Cellular and Moleculargenetic Factors, in Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
name: Bayer
First posted: 2010-11-22
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the impact of exercise training, Acarbose, and the combination of exercise and Acarbose on glycemic control, body composition, insulin sensitivity and other cardiovascular risk markers in type 2 diabetes. Further, muscle biopsies will be obtain to study gene expression. Our hypothesis is that the combination therapy will be superior to monotherapy with exercise or Acarbose.


Eligibility criteria: Inclusion Criteria: Men and women, diagnosis of type 2 diabetes established since at least three months, treatment with diet or maximum one oral anti-diabetic drug, GHb \< 8.5 %, age 45 - 60 years, BMI 25 - 30 kg/m2, no participation in any regular exercise program.

-

Exclusion Criteria: Unable to perform exercise, significant GI-disease, severe heart-disease, renal failure

-

Primary outcomes:
measure: Glycemic control
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Enheten för Metabol Kontroll, Endokrinkliniken, Karolinska University Hospital
Study officials:
affiliation: Dpt of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden
name: Suad Efendic, Professor
role: STUDY_CHAIR
References:
citation: Wagner H, Degerblad M, Thorell A, Nygren J, Stahle A, Kuhl J, Brismar TB, Ohrvik J, Efendic S, Bavenholm PN. Combined treatment with exercise training and acarbose improves metabolic control and cardiovascular risk factor profile in subjects with mild type 2 diabetes. Diabetes Care. 2006 Jul;29(7):1471-7. doi: 10.2337/dc05-2513.
Clinical trial NCT00784771: Hypnotherapeutic Olfactory Conditioning for Posttraumatic Stress Disorder (PTSD)
Official title: Hypnotherapeutic Olfactory Conditioning for Chronic Combat-Related Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Hypnotherapy
Hypnosis
PTSD
Lead sponsor: Herzog Hospital
Sponsor class: OTHER
First posted: 2008-11-04
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic combat-related posttraumatic stress disorder can be difficult to treat. The investigators believe that hypnosis, with a stress on the sensation of scent which often plays a role in the traumatic memories, can offer help for victims of this disorder who continue to suffer after receiving other treatments.

Detailed description: Our study examines the effect of hypnosis upon 36 individuals who suffer from posttraumatic stress disorder incurred in battles or training. The hypnotherapy stresses elements of odor, both in conditioning the subject to relate certain pleasant odors with security and calm, and in gradually reexposing the patient to the olfactory aspects of the traumatic memories. All subjects are taken form the Israel Defense Forces Mental Health Clinic, treated with 6 one-and-a-half-hour hypnotherapy sessions, and evaluated at baseline, end of treatment, after 6 months, and after 12 months, on a battery of clinical scales.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of chronic combat-related PTSD according to DSM-IV criteria (APA, 1994), as determined by semi-structured psychiatric interview conducted by a psychiatrist with over ten years of experience treating PTSD
2. Flashbacks and/or panic attacks with olfactory components
3. Prior attempt at treatment with unsatisfactory results
4. Competence and agreement to sign an informed consent.

Exclusion Criteria:

1. Evidence of psychosis
2. Severe traumatic brain injury
3. Post-concussion syndrome
4. Uncontrolled substance abuse.

Primary outcomes:
measure: Impact of Event Scale
timeFrame: Baseline, 6 weeks, 6 months, one year
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: Baseline, 6 weeks, 6 months, one year
measure: Dissociative Experience Scale
timeFrame: Baseline, 6 weeks, 6 months, one year
Other outcomes:
Locations:
city: Tel Hashomer
country: Israel
facility: Combat Stress Reaction Unit, Medical Corps, Mental Health Department, Israel Defense Forces
state: Ramat Gan
Study officials:
References:
Clinical trial NCT01788371: Nucleoside Analogue Prevent Vertical Transmission of Hepatitis B Virus
Official title: Nucleoside Analogue in Late Preganancy to Prevent Vertical Transmission of Hepatitis B Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B Infection
Chronic Infection
Viremia
Lead sponsor: Beijing YouAn Hospital
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
First posted: 2013-02-11
Enrollment: 700
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To explore the antiviral effect of nucleoside analogue in late pregnancy and the safety of the antiviral drug to fetus.To establish the best therapy strategy to pregnant women with high level of HBV DNA.

Detailed description: Telbivudine and Lamivudine,a preganancy category B medication,reduces HBV DNA and normalizes serum ALT in chronic hepatitis B patients with few adverse effects.Two aspects on the drug use in pregnancy will be evaluated prospectively in this study.

Eligibility criteria: Inclusion Criteria:

HBeAg+CHB pregnant woman gestational age 28 weeks HBV-DNA\>log10 copies/ml

Exclusion Criteria:

co-infection with hepatitis A,C,D,E or HIV evidence of hepatocellular carcinoma decompensated liver disease or significant co-morbidity concurrent treatment with immune-modulators,cytotoxic drugs,or steroids clinical signs of threatened miscarriage in early prenancy evidence of fetal deformity by ultrasound examination the biological father of the child had CHB

Primary outcomes:
measure: The data on its tolerability and safety in HBeAg+ pregnant woman with HBV DNA>6log10 copies/Ml during late pregnancy and infants
timeFrame: perinatal to 28 weeks after infant delivery
measure: Its efficacy in the reduction of HBV vertical transmission rate
timeFrame: perinatal to 28 weeks after infant delivery
Secondary outcomes:
measure: Maternal DNA reduction,ALT normalization, and loss/seroconversion of HBeAg or HBsAg
timeFrame: perinatal to 28 weeks of postpartum
Other outcomes:
Locations:
Study officials:
affiliation: Beijing YouAn Hospital
name: Hua Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03473171: Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting
Official title: Implementation of Nasal Non-Invasive Ventilation With a RAM Cannula in the Inpatient /Outpatient Setting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Respiratory Failure
Keywords: nasal non-invasive ventilation
RAM Cannula
Pediatric Complex Care
Tracheostomy Avoidance
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 5
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to implement a standardized protocol to initiate nasal non-invasive ventilation with RAM nasal cannula (NIV/RAM-NC) with Trilogy mechanical ventilator at Children Memorial Hospital inpatient and outpatient sites, as well as to explore the side effects and complications associated with the use of NIV/RAM-NC in children.


Eligibility criteria: Inclusion Criteria:

* Children admitted to the Children Memorial Hermann Hospital and consulted to Pediatric Pulmonary Service for initiation of NIV/RAM-NC both at the inpatient and outpatient sites.
* Children who fail to wean from chronic respiratory support (CPAP, BiPAP, HFNC) in whom long-term ventilation is considered between 10/2016 - 10/2017 will be included.

Exclusion Criteria:

* Children with minimal setting (CPAP \< 5cmH2O, HFNC \< 3LPM) able to be weaned to regular nasal cannula.
* Patients with upper airway obstruction that may be candidates for surgical procedure will be excluded.

Primary outcomes:
measure: Feasibility as Assessed by Number of Participants Who Had Complications
timeFrame: 7 days after starting the RAM cannula
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Wilfredo De Jesus Rojas, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01212471: A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndrome
Keywords: Sign and symptoms of dry eye disease
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-09-30
Enrollment: 840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A dose ranging study to evaluate safety and efficacy of bromfenac ophthalmic solution in dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Be of either gender and any race 18 years or older

Exclusion Criteria:

* Have a local or systemic disease that could interfere with the assessment of safety or efficacy or that is likely to result in early discontinuation from the study

Primary outcomes:
measure: Mean Ocular Surface Disease Index (OSDI) Total Score
timeFrame: 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: ISTA Pharmaceuticals, Inc.
state: California
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05736471: Cognitive and Affective Processes Online
Official title: Computational Dissociation of the Causes of Cognitive Rigidity in Depression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depression
Keywords: Cognitive rigidity
Foraging
Exploration-Exploitation
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prolific online

Brief summary: This study will provide data for evaluating the psychometric characteristics of the tests assessing cognitive flexibility, including their (1) internal consistency, (2) feasibility and tolerability, their (3) convergent and discriminant validity of cognitive and affective constructs such as those introduced to understand mental disorders, and (4) sensitivity (and correspondence) to individual differences. For these tests to be useful in studying clinical conditions, they must show adequate reliability, validity, and sensitivity in large samples of convenience.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years or older
* English-speaking
* Live in the U.S.
* Have access to an internet connected computer
* Users of the mTurk and Prolific survey website

Exclusion Criteria:

* NA

Primary outcomes:
measure: Relationship of cognitive rigidity to depressive symptoms
timeFrame: 1 hour
measure: Relationship between environmental volatility and cognitive rigidity
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Alexander Herman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03716271: The Light Sword Lens for Presbyopia Compensation
Official title: The Light Sword Lens - a Novel Method of Presbyopia Compensation: a Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Keywords: presbyopia compensation
EDF
Light Sword Lens
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
Collaborators: name: Warsaw University of Technology
First posted: 2018-10-23
Enrollment: 34
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clinical assessment of a new optical element for presbyopia compensation - the Light Sword Lens.

Detailed description: Healthy dominant eyes of presbyopes were examined for visual performance. The examination was performed in the ophthalmic trial frame, which included assessment of 3 trials: reference (with lens for distance correction); stenopeic (distance correction with a pinhole ϕ=1,25 mm) and Light Sword Lens (distance correction with a Light Sword Lens). In each trial, visual acuity was assessed in 7 tasks for defocus from 0.2D to 3.0D while contrast sensitivity in 2 tasks for defocus 0.3D and 2.5D.

Eligibility criteria: Inclusion Criteria:

* emmetropic or hyperopic eyes with a spherical error of maximum +1.75D and astigmatism of ≤ 0.5D.
* Corrected distance visual acuity (CDVA) had to be better than 0.1 logMAR (20/25) and at the same time contrast sensitivity (CS) could not be less than 1.9 logCS. -Uncorrected near visual acuity was required to be worse than 0.4 logMAR (20/50), as a proof of presbyopia.

Exclusion Criteria:

* any history of ophthalmic surgeries
* evidence of serious ocular or brain pathologies affecting visual acuity (VA)
* clinically active inflammation.

Primary outcomes:
measure: Visual Acuity based on The Early Treatment Diabetic Retinopathy Study protocol
timeFrame: day one
measure: Contrast sensitivity based on Pelli-Robson method
timeFrame: day one
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Warsaw University of Technology
name: Krzysztof Petelczyc, PhD
role: STUDY_DIRECTOR
References:
citation: Kakarenko K, Ducin I, Grabowiecki K, Jaroszewicz Z, Kolodziejczyk A, Mira-Agudelo A, Petelczyc K, Skladowska A, Sypek M. Assessment of imaging with extended depth-of-field by means of the light sword lens in terms of visual acuity scale. Biomed Opt Express. 2015 Apr 16;6(5):1738-48. doi: 10.1364/BOE.6.001738. eCollection 2015 May 1.
citation: Mira-Agudelo A, Torres-Sepulveda W, Barrera JF, Henao R, Blocki N, Petelczyc K, Kolodziejczyk A. Compensation of Presbyopia With the Light Sword Lens. Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6870-6877. doi: 10.1167/iovs.16-19409.
Clinical trial NCT02071771: Visual Assessment of DAILIES® AquaComfort Plus® for Astigmatism as Compared to 1-DAY ACUVUE® MOIST® for Astigmatism
Official title: DAILIES® AquaComfort Plus® Toric - Comparative Assessment of Visual and Mechanical Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: DACP Toric
DAILIES® AquaComfort Plus®
Astigmatism
Toric
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate functional vision associated with rotational stability at blink of DAILIES® AquaComfort Plus® Toric (DACP T) compared to 1-DAY ACUVUE® MOIST® for Astigmatism (1DAM A).


Eligibility criteria: Inclusion Criteria:

* Must sign an Informed Consent document;
* Wear toric soft contact lenses within the protocol-specified range;
* Cylinder equal or higher than -0.75 diopters (D) in both eyes;
* Have an acceptable fit with both study contact lenses;
* Willing to wear lenses for a minimum of 5 days per week, 6 hours per day, every day, if possible;
* Best corrected visual acuity (BCVA) of 20/30 Snellen;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any ocular infection, inflammation, abnormality, or disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Require presbyopic correction;
* Any ocular condition observed during examination at the enrollment visit;
* History of herpetic keratitis, ocular surgery or irregular cornea;
* Pregnant or lactating;
* Participation in any clinical trial within 30 days of the enrollment visit;
* Currently wearing Focus® DAILIES® Toric or 1-DAY ACUVUE® MOIST® for Astigmatism;
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: High Contrast Time Controlled Visual Acuity (TCVA) at Day 10
timeFrame: Day 10, each product
Secondary outcomes:
measure: Lens Oscillation at Blink at Day 10
timeFrame: Day 10, each product
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Clinical Manager, EMEA
role: STUDY_DIRECTOR
References:
Clinical trial NCT04783571: Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
Official title: Effects of Auditory Stimulation on Sleep and Memory in Schizophrenia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia
Keywords: sleep
memory
schizophrenia
auditory stimulation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The investigators will test the hypothesis that auditory stimulation (playing quiet sounds during sleep) can normalize brain activity during sleep and improve memory in patients with schizophrenia. The investigators will do this by measuring sleep and memory performance under two conditions separated by one week: receiving auditory stimulation during sleep and not receiving auditory stimulation during sleep. The investigators will study healthy subjects and outpatients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

For healthy controls:

* Male and female subjects
* 18-50 years of age
* Proficient in English

For schizophrenia patients:

* Male and female schizophrenia outpatients
* 18-50 years of age
* Proficient in English
* Able to give informed consent

Exclusion Criteria:

* Pregnant females
* Current use of psychotropic medications (healthy controls only)
* A history of head injury resulting in prolonged loss of consciousness or other neurological sequelae
* IQ \<85
* Neurological disorder (including seizure disorder)
* Significant hearing or vision loss
* Current substance abuse or dependence (nicotine abuse or dependence is not exclusionary)
* Any unstable chronic medical condition that affects sleep
* Diagnosed sleep disorder

Primary outcomes:
measure: Differences in slow-oscillation spindle coupling
timeFrame: Placebo and auditory stimulation naps will be approximately one week apart
Secondary outcomes:
measure: Differences in sleep-dependent consolidation of motor procedural memory
timeFrame: Placebo and auditory stimulation naps will be approximately one week apart
measure: Differences in slow oscillations
timeFrame: Placebo and auditory stimulation naps will be approximately one week apart
measure: Differences in sleep spindles
timeFrame: Placebo and auditory stimulation naps will be approximately one week apart
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Dara Manoach, PhD
role: PRINCIPAL_INVESTIGATOR
References: