louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04311801: Optical Coherence Tomography (OCT) in Elderly Patients After Elective Orthopaedic Surgery
Official title: Optical Coherence Tomography in Elderly Patients After Elective Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change; Retina
Lead sponsor: Masaryk Hospital Usti nad Labem
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: After obtaining informed consent each patient underwent OCT examination, usually one day before elective orthopaedic surgery (knee replacement). The OCT examination was repeated after the surgery. Both eyes were examined separately. After obtaining data the investigators compared the difference.

Detailed description: Inclusion and exclusion criteria evaluated during the pre-anesthesia visit. After obtaining informed consent, patients were referred to OCT examination in the Ophthalmology clinic. The examination was performed in the 48 hours before the surgery. Between the fourth and the seventh postoperative day, the patients underwent control OCT examination. The results of OCT examinations, baseline clinical data and the data on the course of surgery and postoperative care were recorded for further analysis.

Eligibility criteria: Inclusion Criteria:

* Age over 18
* Signed informed consent
* Elective operation

Exclusion Criteria:

* Age under 18
* Refusal to sign informed consent
* Non-elective operation
* Hospitalization on ICU more than 48 hours after surgery Inability to undergo OCT examination Protocol violation

Primary outcomes:
measure: Retinal changes
timeFrame: 4.-7. day post surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Roth S. Perioperative visual loss: what do we know, what can we do? Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i31-40. doi: 10.1093/bja/aep295.
citation: Gupta D, Asrani S. Macular thickness analysis for glaucoma diagnosis and management. Taiwan J Ophthalmol. 2016 Jan-Mar;6(1):3-7. doi: 10.1016/j.tjo.2016.01.003. Epub 2016 Feb 28.
citation: Parizek T, Skulec R, Liehneova I, Prasek P, Cerny V. No significant retinal damage induced by major orthopedic surgery - a pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May;166(2):217-221. doi: 10.5507/bp.2021.022. Epub 2021 Apr 19.
Clinical trial NCT03482401: Disposition of Dietary Polyphenols and Methylxanthines in Mammary Tissues From Breast Cancer Patients
Official title: Metabolic Profiling of Dietary Polyphenols and Methylxanthines in Normal and Malignant Mammary Tissues From Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Polyphenol
Methylxanthine
Metabolism
Breast tissue
Disposition
UPLC-QTOF
Lead sponsor: National Research Council, Spain
Sponsor class: OTHER_GOV
Collaborators: name: Hospital General Universitario Reina Sofía de Murcia
First posted: 2018-03-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, parallel-controlled dietary intervention
Primary purpose: SCREENING

Brief summary: The aim is to characterise the metabolic profiling of dietary polyphenols in normal and malignant breast tissues from breast cancer patients.

Detailed description: The objective of this exploratory trial is to determine the disposition and characterise the metabolic profiling of dietary polyphenols in normal and malignant glandular breast tissues from newly diagnosed breast cancer patients.

The patients consumed a polyphenol-rich dietary supplement containing 37 different phenolics and 2 methylxanthines (theobromine and caffeine) from the diagnosis to the surgery. The metabolic profiling was characterized in normal and malignant breast tissues as well as plasma and urine using UPLC-ESI-QTOF-MS/MS.

Eligibility criteria: Inclusion Criteria:

* Eligible patients are those over 18 years with a newly biopsy-confirmed breast cancer, programmed surgery at least 3 days after the recruitment and no neoadjuvant treatment.

Exclusion Criteria:

* Suspected intolerance to any component of fruits or vegetables.
* Neoadjuvant chemo- or radiotherapy.
* Urgent surgery (less than 3 days after the recruitment).
* Patient under 18 years.
* Patient with breast adenoma.

Primary outcomes:
measure: Quantification of dietary polyphenols and methylxanthines in breast tissues
timeFrame: 1-24 months
Secondary outcomes:
measure: Quantification of dietary polyphenols and methylxanthines in plasma and urine
timeFrame: 8-24 months
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía
Study officials:
affiliation: National Research Council, Spain
name: Juan C. Espín, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03491501: Wearable Robotic Upper Body Exoskeleton for Workers
Official title: Ergonomic Evaluation of Workspaces and Occupational Tasks Targeted for Exoskeleton Support and Definition of Case Studies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Work-Related Condition
Physical Stress
Mental Fatigue
Keywords: Industrial work
physical effort
mental effort
questionnaires
ergonomic evaluation
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Employees of different companies. Only companies involved in the project will be visited.

Brief summary: The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In a first stage of the project, an extensive study involving the end-user companies will be carried out to clearly identify the operator target tasks and typical target task loads for which the exoskeleton will be designed. Based on standard ergonomic evaluation scales (RULA and NIOSH, the Need for Recovery Scale and the Ovako Working Posture Analysing System), high risk tasks will be identified in the field, based on the evaluated information about the workspace configuration, the performed operations and their physical constraints. These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front, to the side, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. Important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.


Eligibility criteria: Inclusion Criteria: Industrial employees

-

Exclusion Criteria:

* non-able bodied individuals

Primary outcomes:
measure: Questionnaire
timeFrame: The time point of data collection: An average of 1yr
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Vrije Universiteit Brussel
state: Vlaams Brabant
Study officials:
References:
Clinical trial NCT01103401: Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
Official title: Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Veroia General Hospital
Sponsor class: OTHER
First posted: 2010-04-14
Enrollment: 145
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial compares two regimens of topical therapy:

* tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day
* combination of tobramycin 0.3% - dexamethasone 0.1% (TobraDex®, Alcon), one drop four times/day, plus Ketorolac tromethamine 0.5% (Acular®, Allergan), one drop three times/day.

Patients are independently assessed by two ophthalmologists. On days 7,14,21,28 patients are evaluated for

* corneal edema
* conjunctival hyperemia
* anterior chamber (Tyndall) reaction.

The investigators purpose was to evaluate the benefit of adding a non-steroid agent to an antibiotic/steroid combination after uneventful phacoemulsification. Adopting a weekly follow-up, to gain insight into the optimal duration of postoperative treatment and to examine whether risk factors for inflammation exist.

Detailed description: Patients were randomized to: i) tobramycin 0.3% - dexamethasone 0.1% one drop qid (TD group, n=72, 28 days) and ii) combination of tobramycin 0.3% - dexamethasone 0.1%, one drop qid, plus Ketorolac tromethamine 0.5%, one drop tid (TD-K group, n=73, 28 days). Patients undergoing vitrectomy due to posterior capsule rupture were excluded. On days 7, 14, 21, 28, the frequency of inflammation-related signs \[corneal edema, conjunctival hyperemia, anterior chamber (Tyndall) reaction\], as well as the best corrected visual acuity (BCVA) were measured. On day 21, logistic regression was performed to evaluate risk factors for inflammation.

Eligibility criteria: Inclusion Criteria:

* phacoemulsification (due to cataract)
* uneventful phacoemulsification surgery

Exclusion Criteria:

* history of intraocular surgery in the operated eye,
* any previous episode of uveitis in the operated eye,
* severe systemic disease (heart failure NYHA stage III of IV, end-stage renal failure, pulmonary failure, patients receiving chemotherapy),
* regular, systemic use of steroid or non-steroid anti-inflammatory drugs during the last three months
* disruption of the anterior lens capsule

Primary outcomes:
measure: Visual acuity, corneal edema, Tyndall reaction, redness
timeFrame: 1,7,14,28 post-operative day, Up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: leopapazisis@yahoo.gr
name: Leonidas E Papazisis, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06361901: Comparison of Therapeutic Effect Between Speech Rehabilitation Program and Speech Therapy in Stroke Patients With Aphasia
Official title: Comparison of Therapeutic Effect and Brain Activity According to Language Rehabilitation Program and Language Therapy in Patients With Speech Impairment After Stroke. Prospective, Randomized, Single-blind, Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Aphasia
Speech Therapy
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study will provide precise and intensive speech rehabilitation treatment program to patients with speech disorders after stroke, and compare clinical evaluations with the conventional speech therapy patient group.

Clinical evaluation tools will be performed before and after the treatment for all patients

* K-Western Aphasia Battery for aphasia assessment tools
* Cerebral blood flow changes with near-infrared spectroscopy

Detailed description: During the initial evaluation of this study, the patient's gender, age, and onset of stroke lesion occurrence are collected and a cognitive evaluation is performed. In addition, the K-Western Aphasia Battery for aphasia assessment tools(K-WAB) and Cerebral blood flow changes with near-infrared spectroscopy will be performed. All participants will be assigned to a test group or control group. In addition to the existing speech rehabilitation treatment, the test group will receive a speech rehabilitation program, and the control group will receive the same treatment as the existing speech rehabilitation treatment.

After treatment is completed, the K-WAB test and near-infrared spectroscopy will be performed again.

Eligibility criteria: Inclusion Criteria:

* Adults over 19 years old
* Those with speech disorders that occurred after a stroke was diagnosed
* Those who can follow the clinical study procedures
* Those who voluntarily signed the consent form

Exclusion Criteria:

* Patients who have difficulty to consent to research and participate in speech rehabilitation programs due to cognitive decline

Primary outcomes:
measure: Aphasic quatient
timeFrame: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
Secondary outcomes:
measure: Change of cerebral blood flow
timeFrame: Evaluate two times ; Before speech therapy treatment program (baseline) and within 7days after the treatment period.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Rehabilitation Medicine, Korea University Guro Hospital
Study officials:
References:
Clinical trial NCT04642001: Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions
Official title: Association of Two Desensitizing Protocols to Control Dentinal Hypersensitivity in Non-carious Lesions: A Randomized, Double-blind Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Hypersensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This randomized, double-blind clinical trial evaluated the effect of photobimodulation associated with 8% strontium acetate in the treatment of dentin hypersensitivity in non-carious lesions and analyzed the risk factors with the patient's quality of life.


Eligibility criteria: Inclusion Criteria:

* Age between 18 to 50 years
* Good general health
* Dental sensitivity with response ≥ 4 on the 10 cm long visual analog scale (EVA)
* Presence of at least two hypersensitive teeth with a depth of up to 1 mm (measured with a millimeter probe)
* Exposed root surface caused by abrasion, erosion or gum recession

Exclusion Criteria:

* Volunteers using analgesic medication
* Presence of teeth with evidence of carious lesions, pulpitis, defective restorations and moderate or severe periodontal disease
* Patients who had undergone any whitening therapy or professional or homemade desensitizer in the last six months
* Patient with fixed orthodontic appliances
* Drug users or pregnant women were also excluded.

Primary outcomes:
measure: dentin sensitivity
timeFrame: 30 days after the end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Universidade Federal do Pará
state: Pará
Study officials:
References:
Clinical trial NCT03300401: Contrast-Enhanced Ultrasound in Diagnosing Patients With Liver Cancer Undergoing Yttrium-90 Radioembolization
Official title: The Role of Quantitative Contrast-Enhanced Ultrasound in Yttrium-90 (90Y) Radioembolization of Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-10-03
Enrollment: 0
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: This pilot clinical trial studies how well contrast-enhanced ultrasound in diagnosing patients with liver cancer who are undergoing Yttrium-90 radioembolization. Contrast-enhanced ultrasound may provide detailed imaging of the tumor arteries after the injection of a contrast-agent consisting of microbubbles, and may predict how much Yttrium-90 will deposit in the tumor.

Detailed description: PRIMARY OBJECTIVES:

I. Investigate the relationship between hepatocellular carcinoma (HCC) tumor perfusion on pre-procedural contrast-enhanced ultrasound (CEUS) time intensity curve (TIC) and post-procedural Yttrium-90 (90Y) microsphere distribution after 90Y radioembolization (RE).

SECONDARY OBJECTIVES:

I. Study the potential of serial CEUS TIC examinations as a marker of tumor treatment response as assessed at 20 - 24 week computed tomography (CT) follow-up.

OUTLINE:

Patients receive perflutren or sulfur hexafluoride lipid microspheres and undergo CEUS at baseline, 2 and 4 weeks, and 3 and 6 months. Patients also undergo positron emission tomography/computed tomography (PET/CT) after standard of care 90Y radioembolization at baseline.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for 90Y radioembolization for HCC as part of their standard of care

Exclusion Criteria:

* Patients who have already received tumor treatment (either systemic or loco-regional such as previous Y90RE, microwave or radiofrequency \[RF\] ablation or transarterial chemoembolization \[TACE\])
* Pregnant or nursing
* Known cardiac shunt
* Known pulmonary hypertension
* History of hypersensitivity to Definity (perflutren lipid microsphere) or Lumason
* History of hypersensitivity to iodinated contrast agent
* Cannot consent for himself or herself

Primary outcomes:
measure: Local tumor response to therapy
timeFrame: Up to 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Harshawn Malhi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02040701: Sleep Disordered Breathing in Children: Inflammation and Oxidative Stress
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disordered Breathing (SDB)
Endothelial Dysfunction
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children ages 6 months-18 years who will undergo overnight sleep study at the Dana Children's hospital, Tel Aviv Medical Center because of snoring and suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy

Brief summary: The purpose of the study is to measure markers of inflammatory and oxidative stress known to be associated with cardiovascular morbidity in snoring children.

In addition, to measure markers of local inflammation and to evaluate the response to treatment.


Eligibility criteria: Inclusion Criteria:

* children ages 6 months-18 years
* suspected sleep-disordered breathing or will attend the pre-operative ENT clinic for adenoidectomy or adenotonsillectomy

Exclusion Criteria:

* craniofacial abnormalities
* neurological disorders
* genetic disorders
* infectious disease
* chronic inflammatory disease
* any underlying chronic medical condition

Primary outcomes:
measure: Plasma inflammatory-markers
timeFrame: After the blood analyzed
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Dana Children's hospital, Tel Aviv Medical Center
Study officials:
References:
Clinical trial NCT06415201: Interactive AI-based Mental Health Service for the Patients With Cancer
Official title: Scenario-based Clinical Interview Data Construction and User Experience Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: mental health
distress
interactive artificial intelligence
virtual human
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Dongguk University Medical Center
name: Eulji University Hospital
First posted: 2024-05-16
Enrollment: 360
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult cancer patients without severe cognitive decline

Brief summary: The aims of this study are developments of mental health care services for cancer patients based on interactive artificial intelligence. To do these things, survey of unmet medical needs and data collection of clinical interviews will be done, and newly developed assessment and intervention scenarios will be simulated to cancer patients group.

Detailed description: A total of 20 people will be recruited from 3 institutions to investigate unmet medical needs. Based on the needs, we will develop scenarios to assess, classify, explain and conduct supportive interviews. We plan to develop a stress self-management scenario that helps manage lifestyle habits and provides meditation-based cognitive therapy. For moderate to severe distress, we plan to develop scenarios to link medical care and manage suicide risk. We plan to conduct interviews with a total of 300 people to collect clinical interview data for scenario development.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with malignant tumor and undergoing treatment, or patients undergoing follow-up after completing curative treatment

Exclusion Criteria:

* Patients unable to consent to research or be interviewed due to cognitive decline

Primary outcomes:
measure: Distress
timeFrame: baseline
measure: Quality of life measurement
timeFrame: baseline
measure: Stress
timeFrame: baseline
measure: Self-esteem
timeFrame: baseline
measure: Acceptance of Disability
timeFrame: baseline
measure: Pain measurement
timeFrame: baseline
measure: Insomnia
timeFrame: baseline
measure: Quality of sleep
timeFrame: baseline
measure: Fatigue
timeFrame: baseline
measure: Anxiety & Depression
timeFrame: baseline
measure: Suicidality
timeFrame: baseline
measure: Fear of Disease Progression
timeFrame: baseline
measure: Social Support
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bong-jin Hahm, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: