louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06460389: Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation with and Without Digital Assistance
Official title: Comparison of Visual Outcomes After Extended Depth of Focus Intraocular Lens Implantation with and Without Digital Assistance
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Presbyopia
Pseudophakia
Cataract
Refractive Errors
Keywords: pseudophakic presbyopic correction
extended depth of field intraocular lenses
visual curve
visual acuity
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants that underwent Extended Depth of Focus Intraocular Lens Implantation With and Without Digital Assistance.

Brief summary: The primary objective of this study is to compare the postoperative visual acuity curves of patients that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

Detailed description: This is a prospective, comparative study of 60 patients diagnosed with grade 2 cataracts (according to LOCS III) that underwent one of the following surgical procedures: Insertion of an extended depth of focus intraocular lens with digital assistance and insertion of an extended depth of focus intraocular lens without digital assistance.

In these patients, a comparison of postoperative visual acuity curves of both groups will be conducted. Visual acuity curves will be designed using the validated digital optotype Democritus Digital Acuity \& Reading Test (DDART). Assessment of visual acuity will be performed at 9 different distances (25, 28, 33, 40, 50, 60, 100, 200, 300 cm). Overall visual acuity curves and the area under the curve will be formed through the application as the primary means of evaluating visual capacity. Additionally, the degree of subjective satisfaction of the patient will be evaluated through an interview (NEI-VFQ 25). All examinations will be conducted according to standard clinical practice.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of grade 2 cataracts (according to LOCS III)
* age \>45 years.

Exclusion Criteria:

* Inability to understand the Greek language and respond to the interview
* conditions of the posterior or corneal segment
* glaucoma
* previous intraocular surgery

Primary outcomes:
measure: Visual acuity assessment
timeFrame: 4 months
measure: Area of the curve (AOC) assessment
timeFrame: 4 months
measure: the degree of subjective satisfaction of the patient
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
Study officials:
affiliation: Democritus University of Thrace
name: Georgios Labiris
role: STUDY_CHAIR
References:
Clinical trial NCT01103089: Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
Official title: Observations From Long Term Responders in the Gefitinib (Iressa) Expanded Access Program (EAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: NSCLC
EGFR
gefitinib
observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-04-14
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients from the gefitinib Expanded Access Programme in the Netherlands.

Brief summary: The purpose of the study is to determine patient characteristics from patients that have used Iressa for a period of minimal 3 years.


Eligibility criteria: Inclusion Criteria:

* Participation in the gefitinib Expanded Access Program
* Patient still uses gefitinib in September 2009

Primary outcomes:
measure: The following characteristics of the 'long-term responders' from the EAP; gender, ethnicity, smoking history (pack years), EGFR-TK mutation and histology of NSCLC.
timeFrame: Characteristics will be recorded once, retrospectively
Secondary outcomes:
measure: To assess the long-term safety in subjects treated with gefitinib by collecting information on: All adverse events that have lead to an interruption/reduction of gefitinib or another intervention
timeFrame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
measure: long-term safety in subjects; what real life data measures are being taken by lung physicians to counter side effects caused by long term gefitinib treatment; the number, reason, effect and description of interventions that have been taken
timeFrame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
measure: long-term safety: Number, reason and effect of interruptions during gefitinib use to determine side effects typical for the long-term treatment with gefitinib
timeFrame: Once, retrospectively for the period the patient has used gefitinib (minimal 3 years)
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research Site
city: Apeldoorn
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Groningen
country: Netherlands
facility: Research Site
city: Helmond
country: Netherlands
facility: Research Site
city: Hengelo
country: Netherlands
facility: Research Site
city: Hoofddorp
country: Netherlands
facility: Research Site
city: Leiden
country: Netherlands
facility: Research Site
city: Veldhoven
country: Netherlands
facility: Research Site
city: Venlo
country: Netherlands
facility: Research Site
city: Zutphen
country: Netherlands
facility: Research Site
Study officials:
References:
Clinical trial NCT06030089: Plasma Dosage of Venetoclax in the Fup of AML Patients Treated With Aza + Ven
Official title: Plasma Dosage of Venetoclax in the Follow-up of Acute Myeloid Leukemias Ineligible for Intensive Chemotherapy in the First Line of Treatment and Treated With Azacitidine + Venetoclax. Pilot Study VENETACIBLE
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
venetoclax
azacitidine
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study proposes to correlate the plasma dosage of VEN with the inhibition of its Bcl-2 target during the first treatment cycle. VEN will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of Bcl-2 serine 70. In parallel, BH3 profiling will be evaluated sequentially. All these analyses will be correlated with treatment toxicity, response rate and overall patient survival. This pilot study will highlight the inter-individual variability of this AZA + VEN combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.


Eligibility criteria: Inclusion criteria :

* Patient with acute myeloid leukemia (AML) not eligible for intensive chemotherapy
* Patients aged 18 or over
* Patient treated with the combination azacitidine (AZA) + venetoclax (VEN)
* Patient having signed the study informed consent form
* Patient with social security coverage

Exclusion criteria :

* Patients receiving treatment inhibiting or inducing Cytochrome CYP3A4
* Presence of an active, uncontrolled infection
* Patient participating or having participated in a clinical drug trial in the month prior to inclusion.
* Vulnerable persons

Primary outcomes:
measure: Plasmatic dosage
timeFrame: Before treatment
measure: Plasmatic dosage
timeFrame: At Day 5 of 1st round of chemotherapies
measure: Plasmatic dosage
timeFrame: At Day 9 of 1st round of chemotherapies
measure: Plasmatic dosage
timeFrame: At 12 months after start of treatment or at relapse whichever comes first
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital la Conception
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: CHU of Nice
name: Thomas Cluzeau
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03540589: Distraction and Vibration for Minimizing Pain During Childhood Vaccination
Official title: Distraction and Vibration for Minimizing Pain During Childhood Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Due to Childhood Vaccination
Lead sponsor: Hospital Nossa Senhora da Conceicao
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 204
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Vaccine pain control is one of the actions suggested to support the delivery of vaccines that are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main reasons why children and their parents fail to do them properly. Thus, it is very important to investigate which interventions can bring greater benefit in the control of pain.This is a randomized clinical trial aiming to assess the impact of video distraction and vibration device on pain during the vaccination of children between one and three years.


Eligibility criteria: Inclusion Criteria:

* Children between 1 year and 3 years, 11 months and 29 days of life.
* Be accompanied by legal guardian.
* Apply only one injectable vaccine at the time of the research.

Exclusion Criteria:

* Refuses to sign the consent form.
* Have already been included in the study previously.

Primary outcomes:
measure: Duration of crying in seconds
timeFrame: Through study completion, an average 6 months
Secondary outcomes:
measure: The satisfaction of parents
timeFrame: Through study completion, an average 6 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande Do Sul
Study officials:
References:
Clinical trial NCT02278289: Comparative Effectiveness of Ultrasound and Paraffin Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Trial
Official title: Comparative Effectiveness of Ultrasound and Paraffin Therapy in Patients With Carpal Tunnel Syndrome: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2014-10-29
Enrollment: 60
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: The purpose of this study is to compare the efficacy of combining a wrist orthosis with either ultrasound therapy or paraffin bath therapy in treating carpal tunnel syndrome patients.

Detailed description: The purpose of this exploratory study is to compare the combination of a wrist orthosis with either ultrasound therapy or paraffin bath therapy in the treatment of carpal tunnel syndrome patients. We hypothesized that ultrasound therapy might be more effective than paraffin therapy because it provides both thermal and nonthermal effects.

Eligibility criteria: Inclusion Criteria:

* patients to have subjective symptoms (such as pain and/or numbness in the median nerve distribution of the digits or nocturnal pain). Furthermore, patients were required to have either a positive Phalen's sign or a positive Tinel's sign along with electrophysiological evidence of carpal tunnel syndrome.

Exclusion Criteria:

* (1) age younger than 18 years old; (2) underlying medical disorders, such as diabetes mellitus, renal failure, autoimmune disease or hypothyroidism; and (3) pregnancy, previous wrist trauma or surgery.

Primary outcomes:
measure: Functional Status Scale of the Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 8 weeks
Secondary outcomes:
measure: Symptom Severity Scale of the Boston Carpal Tunnel Syndrome Questionnaire
timeFrame: 8 weeks
measure: Pain Scale
timeFrame: 8 weeks
measure: Difference of Monofilament Sensory Test (Before and After Treatment)
timeFrame: 8 weeks
measure: Difference in Palmar Pinch Power Test (Before and After Treatment)
timeFrame: 8 weeks
measure: Difference in the Distal Sensory Latencies of the Median Nerve (Before and After Treatment)
timeFrame: 8 weeks
measure: Difference in the Distal Motor Latencies of the Median Nerve (Before and After Treatment)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Taipei TzuChi hospital
name: Yi Shiung Horng
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang YW, Hsieh SF, Horng YS, Chen HL, Lee KC, Horng YS. Comparative effectiveness of ultrasound and paraffin therapy in patients with carpal tunnel syndrome: a randomized trial. BMC Musculoskelet Disord. 2014 Nov 26;15:399. doi: 10.1186/1471-2474-15-399.
Clinical trial NCT03196089: Effect of Short-term Oxygen During CPET in COPD
Official title: Effect of Short-term Oxygen Therapy on Cardiopulmonary Exercise (CPET) Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: In a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* diagnosis of chronic obstructive pulmonary disease
* on optimized medical therapy and in stable condition for at least 4 week
* desaturate in the 6 minute walking test by at least 4% to values \<92%

Exclusion Criteria:

* unstable conditions
* pregnant women
* patients with relevant concomitant lung disease and severe daytime hypoxemia

Primary outcomes:
measure: Watt
timeFrame: 1 day
measure: Exercise time
timeFrame: 1 day
Secondary outcomes:
measure: Peak Oxygen uptake
timeFrame: 1 day
measure: Respiratory Exchange ratio
timeFrame: 1 day
measure: Ventilatory equivalent of carbon dioxide (VE/VCO2) slope
timeFrame: 1 day
measure: End-tidal pressures of carbon dioxide (PET CO2)
timeFrame: 1 day
measure: Changes in arterial blood parameters
timeFrame: 1 day
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich, Division of Pneumology
Study officials:
affiliation: University Hospital Zurich, Division of Pneumology
name: Silvia Ulrich Somaini, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05779189: Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults
Official title: Effects of Game-based Virtual Reality Intervention on Senior Fitness, Fall Prevention and Balance Function Among Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to explore the effectiveness between game-based virtual reality intervention and conventional health education in improving older adults' balance knowledge, and let them know how to prevent falling. The intervention group will receive virtual reality games in person and read the health education flier, while the control group was assigned to read the health education flier and follow suit the video of balance exercise.

Detailed description: Falls can lead to disability, sickbed and even death of the elderly, and it ranks second among the top ten which causes death in Taiwan. In the past, when multifaceted exercise interventions were conducted for the elderly, most of them focused on group strength training and aerobic exercise, but lacked individualized balance training, resulting in a low degree of cooperation.

Eligibility criteria: Inclusion Criteria:

* Elderly people over the age of 65-99.

Exclusion Criteria:

* cognitive impairment
* neurological diseases
* severe osteoporosis
* lower limb joint surgery
* discomfort symptoms during exercise

Primary outcomes:
measure: Senior Fitness Test
timeFrame: Right after the intervention
measure: Falls Efficacy Scale International
timeFrame: Right after the intervention
measure: Balance or sensory-Integration test
timeFrame: Right after the intervention
measure: Balance of postural-stability test
timeFrame: Right after the intervention
measure: Modified Clinical Test for Sensory Integration of Balance (m-CTSIB)
timeFrame: Right after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei county
country: Taiwan
facility: Taipei Medical University
Study officials:
References:
Clinical trial NCT05112289: A Study to Evaluate White Matter Hyperintensities in Migraine
Official title: White Matter Hyperintensities in Migraine: A Multi-modal Imaging Project to Classify Disease Pathology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Migraine
Small Vessel Ischemic Disease
Multiple Sclerosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to better understand brain white matter hyperintensities (WMH) in women with migraines


Eligibility criteria: Inclusion Criteria - Migraine (N=20):

* Female only.
* Ages 20-45 years.
* Presence of WMH on MRI.

Exclusion Criteria:

* History of SVI and/or history of MS or other neurological disease other than migraine.
* History of cancer or organ transplantation.
* Contraindication to MRI.
* Pregnancy.
* History of abnormal brain MRI other than WMH.
* Subjects not willing to comply with the study procedures will be removed from the study.

Inclusion Criteria - SVI disease (n=10):

* Female only
* Ages \> 60 years.
* Presence of WMH on MRI.

Exclusion Criteria:

* History of migraine and/or history of MS or other neurological disease other than SVI.
* History of cancer or organ transplantation.
* History of abnormal brain MRI other than WMH.
* Pregnancy.
* History of abnormal brain MRI other than WMH.
* Subjects not willing to comply with the study procedures will be removed from the study.

Inclusion Criteria - MS (n=10):

* Female only.
* Ages 20-45.
* Presence of WMH on MRI.

Exclusion Criteria:

* History of migraine and/or history of SVI or other neurological disease other than MS.
* History of cancer or organ transplantation.
* History of abnormal brain MRI other than WMH.
* Pregnancy.
* History of abnormal brain MRI other than WMH.
* Subjects not willing to comply with the study procedures will be removed from the study.

Primary outcomes:
measure: WMH imaging disease parameters
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Catherine Chong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01537289: Pigtail Catheter Versus Chest Tube in the Management of Traumatic Pneumothorax
Official title: A Prospective Randomized Study of 14-French (14F) Pigtail Catheters Versus 28F Chest Tubes in Patients With Traumatic Pneumothorax: Impact on Tube-Site Pain and Failure Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Traumatic Pneumothorax
Keywords: Trauma
Pneumothorax
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A small 14-French(F) pigtail catheter (PC) has been shown to work equally well with traditional 32-40F chest tube (CT), especially in traumatic pneumothorax.

There are no clinical data on tube-site pain. The investigators hypothesize that PC tube site pain is less than CT.

Detailed description: Primary outcome: - Tube site pain

* Pain medication requirement

Secondary outcome: failure rate insertion-related complication

Eligibility criteria: Inclusion Criteria:

* 18 years old and above
* Suffer traumatic pneumothorax that requires chest tube insertion

Exclusion Criteria:

* Emergency chest tube insertion
* patient refuses
* patient is unable to provide or rate pain assessment
* prisoner
* pregnancy
* patient with GCS less than 13

Primary outcomes:
measure: Change in Tube-site pain, pain medication requirement
timeFrame: day 0, 1, 2
Secondary outcomes:
measure: failure rate
timeFrame: patients will be followed for the duration of hospital stay, an expected average of 2 weeks
measure: Insertion-related complication
timeFrame: day 0
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Ariznoa Medican Center, Main campus
state: Arizona
Study officials:
affiliation: University of Arizona
name: narong kulvatunyou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kulvatunyou N, Erickson L, Vijayasekaran A, Gries L, Joseph B, Friese RF, O'Keeffe T, Tang AL, Wynne JL, Rhee P. Randomized clinical trial of pigtail catheter versus chest tube in injured patients with uncomplicated traumatic pneumothorax. Br J Surg. 2014 Jan;101(2):17-22. doi: 10.1002/bjs.9377.