louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04357912: Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
Official title: Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: epilepsy
exercise
activity tracker
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Texas Neurological Society Research Grant-2020
First posted: 2020-04-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate standard of care exercise education alone or in combination with a wearable physical activity tracker in people with epilepsy (PWE) to determine the most effective way to increase physical activity and measure impact on depression, anxiety, quality of life, sleep, and seizure frequency.


Eligibility criteria: Inclusion Criteria:

* patient of the Texas Comprehensive Epilepsy Program at UTHealth-McGovern Medical School
* diagnosis of epilepsy
* be able to provide consent in English
* complete surveys independently
* be able to sync Fitbit data

Exclusion Criteria:

* currently using a wearable physical activity tracker prior to enrollment
* pregnant or planning to become pregnant during the study duration
* planning to undergo epilepsy surgery during the study duration

Primary outcomes:
measure: Number of steps taken by participant
timeFrame: 3 months after enrollment
measure: Total distance traveled by participant
timeFrame: 3 months after enrollment
measure: Total time participant is active
timeFrame: 3 months after enrollment
Secondary outcomes:
measure: Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
timeFrame: Baseline
measure: Depression as measured by the Patient Health Questionnaire depression scale (PHQ-9)
timeFrame: end of study (3 months after enrollment)
measure: Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Baseline
measure: Anxiety as measured by the General Anxiety Disorder 7-item scale (GAD-7)
timeFrame: end of study (3 months after enrollment)
measure: Sleep as measures by the Epworth Sleepiness Scale (ESS)
timeFrame: Baseline
measure: Sleep as measures by the Epworth Sleepiness Scale (ESS)
timeFrame: end of study (3 months after enrollment)
measure: Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey
timeFrame: Baseline
measure: Quality of life as assessed by the Quality of Life in Epilepsy (QOLIE-10-P) survey
timeFrame: end of study (3 months after enrollment)
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: Katherine Harris, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00769912: Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia
Official title: Evaluation of of a Prefixed 50% N2O- 50%O2 Mixture in Legal Abortion Under Local Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abortion
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2008-10-09
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate effectiveness of a prefixed 50% N2O- 50%O2 mixture in legal abortion under paracervical block.


Eligibility criteria: Inclusion Criteria:

* Major patient having signed an assent waits having chosen to make the intervention under local anesthetic

Exclusion Criteria:

* Minor
* contraindication in the use of the paracetamol, the lidocaine
* Porphyries

Primary outcomes:
measure: Pain during the intervention
timeFrame: 4 months
Secondary outcomes:
measure: Pain at the end of the intervention and 2 hours after. Unwanted events
timeFrame: 4 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service de Gynécologie Obstétrique, Hôpital La Conception
Study officials:
affiliation: Assistance Publique des Hopitaux de Marseille
name: Aubert AGOSTINI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02115412: Validation of Medication Non-adherence Model (UK)
Official title: Validation of Medication Non-adherence Model (UK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Chronic Obstructive Pulmonary Disease
Chronic Illness
Primary Care
Medication Management at Home
Lead sponsor: Philips Healthcare
Sponsor class: INDUSTRY
First posted: 2014-04-16
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with chronic illness taking more than 3 medications. These patients will be between the age of 18 - 89

Brief summary: Research has shown that nearly 50% of patients with chronic conditions around the globe do not adhere to their prescribed medicine, leading to enormous cost to the healthcare providers. Non-adherence can be due to various forms and have multiple causes.

To address this need, Philips Research has developed Medication Non-adherence model. This tool will help in developing a systemic way of assessing medication non-adherence and providing decision support for targeted intervention to healthcare professionals. The aim of this study is to validate this model with 750 chronically ill patients in UK.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic disease between 18 -89 years old.
* Chronic medication use (\> 3 medications; excluding analgesic, ointment and eye drop medication)
* Patients registered with a given Pharmacy at least 1 year before entering into the study.

Exclusion Criteria:

* Patients who are illiterate in English.
* Patients who are unable to give consent to the study.
* Enrolled in another clinical trial, which requires change in their routinely medication.
* Patients currently using automatic medication reminder services (excluding the pharmacy service).
* Patients with dementia or any other mental conditions, that might affects the accuracy of the answers provided.

Primary outcomes:
measure: Adherence determinants
timeFrame: 6 months
Secondary outcomes:
measure: Medication usage
timeFrame: 18 months
Other outcomes:
measure: Adverse Events
timeFrame: 18 months
Locations:
city: Bolton
country: United Kingdom
facility: Swan Lane Medical Centre
state: Greater Manchester
city: King's Lynn
country: United Kingdom
facility: Vida Health, 39 Gayton Road
state: Norfolk
city: Carlton Colville, Lowestoft
country: United Kingdom
facility: Rosedale Surgery
state: Suffolk
city: Norfolk
country: United Kingdom
facility: Wymondham Medical Practice
Study officials:
References:
Clinical trial NCT01851512: A Study to Evaluate the Tolerability, Safety and Pharmacokinetic Characteristics of DA-3803
Official title: Single-Blind, Randomized, Comparative, Phase I Study to Evaluate the Tolerability, Safety, and Pharmacokinetic Characteristics of Human Chorionic Gonadotropin Between Two Recombinant hCG Products, DA-3803 Injection and Ovidrel Liquid Injection, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infertility
Induction of Ovulation
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-05-10
Enrollment: 27
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-blind, randomized, comparative, phase I study to evaluate the tolerability, safety and pharmacokinetic characteristics of human chorionic gonadotropin between two recombinant hCG products named DA-3803 injection and ovidrel liquid injection, in healthy subjects. The subjects will injected with these two injections at the the 21day-interval of time and their conditions including vital signs, blood, clinical examination will be carefully observed.


Eligibility criteria: Inclusion Criteria:

* No medical history relating to the alimentary system, liver system, heart system, haematological disease
* Ideal body weight +/- 20%

Exclusion Criteria:

* acute disease within 28 days
* medical history that might affect the absorption, distribution, secretion, metabolism of drugs
* metrectomy surgery
* desexualization
* tubal ligation
* menopause
* pregnancy
* not able to use contraception
* drink alcohol more than 14 units/week
* smoker who smokes 10 or more cigarettes

Primary outcomes:
measure: Concentration in serum of hCG examined by non-compartmental analysis
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Anam Hospital
name: Ji-Young Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Kyoung-Ah Kim, Ph.D.
role: STUDY_DIRECTOR
affiliation: Korea University Anam Hospital
name: Un Jip Kim, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Korea University Anam Hospital
name: Soo Kyung Kim, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: Korea University Anam Hospital
name: Hyun Tae Park, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03485612: Analysis of Change of Optic Nerve Sheath Diameter in in Patients Operated for Urological Reasons
Official title: Analysis of Change of Optic Nerve Sheath Diameter in in Patients Operated for Urological Reasons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anaesthetic Complication Neurological
Central Nervous System Depression
Keywords: Optic Nerve Sheath Diameter
Urological Anaesthesia
point of care USG
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing urologic operation Adults 18 to 90 years of age American Society of Anesthesiologists Physical grade 1-3

Brief summary: The assessment of the diameter of the optic nerve sheath (ONSD) using ultrasound can be a very helpful tool in the assessment of increased intracranial pressure in patients operated for urological procedures.

Detailed description: Advantages of using ultrasound in the assessment of intracranial pressure:

simple, bedside examination, repetitive, generally available, cheap, no exposure to X-rays, no need to transport the patient to the CT laboratory

Differential diagnosis:

Widening of the size of the optic nerve sheath outside of increased intracranial pressure may occur in the following pathologies:

optic neuritis optic nerve injuries meningioma of the optic nerve arachnoid cyst around the optic nerve tumors of the cavernous sinus Blood edema may occur due to impaired blood flow. The research is to determine whether the patient's position for urological procedures is safe for the patients and whether as a result of staying in such a position there is no development of cerebral edema.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing urologic operation
* Adults 18 to 90 years of age
* American Society of Anesthesiologists Physical grade 1-3

Exclusion Criteria:

* Patients who did not agree to participate in the study
* Patients with ophthalmic diseases
* Patients with previous history of ophthalmic surgery
* Patients with neurological disorders
* Patients with history of head surgery due to neurological disorders
* Patients with history of disease with increased intracranial pressure
* Patients with history of disease with increased intraocular pressure

Primary outcomes:
measure: Optic Nerve Sheath Diameter
timeFrame: 10 hours
Secondary outcomes:
measure: neurological complications
timeFrame: 5 days
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: University Hospital in Cracow
Study officials:
References:
Clinical trial NCT05897112: Comparative Efficacy of 10% Potassium Hydroxide Solution Versus Cryotherapy in Molluscum Contagiosum
Official title: Comparison of 10% Potassium Hydroxide Solution Versus Cryotherapy in the Treatment of Molluscum Contagiosum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Molluscum Contagiosum
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A total of sixty patients presented to the outpatient dermatology department of Combined military hospital (CMH) Abbottabad with signs of molluscum contagiosum clinically diagnosed meeting inclusion criteria were enrolled. Sample size was calculated using WHO sample size calculator. They were divided into two groups i.e Group A and Group B using lottery method. Patients in Group A were subjected to cryotherapy (liquid nitrogen gas) whereas patients in Group B patients were subjected to 10% potassium hydroxide solution for 3 weeks and were followed up at 2nd, 4th, 8th and 12th week for observing the progress of therapy in both groups on each follow up visit and ascertaining the efficacy respectively.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of molluscum contagiosum having 3-20 lesion
* no history of treatment before
* willingness to participate (given by parents)

Exclusion Criteria:

* Patients with facial lesions
* known immunodeficiency
* tendency for hypertrophic scarring
* known hypersensitivity

Primary outcomes:
measure: Efficacy was assessed at 12th week by the clearance of lesion or not
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottābād
country: Pakistan
facility: CMH Abbottabad
state: Khyber Pakhtunkhwa
Study officials:
References:
Clinical trial NCT06487312: Clinical Trial to Evaluate the Effectiveness and Safety of a Remote Automated Ultrasound Diagnostic System for Automated Ultrasound Examinations: a Prospective, Multicenter Study
Official title: Clinical Application of Multi-organ Multi-task Autonomous Ultrasound Embodied Intelligent Robot
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Ultrasound
Thyroid
Carotid Artery
Liver
Gallbladder
Spleen
Pancreas
Kidney
Keywords: Ultrasound Intelligent Robot
Multitasking
Automated Ultrasound
Clinical application
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 1000
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: This study will recruit adults over 18 years old, especially those who need multi-organ ultrasound examinations. Participants need to be able to understand and sign the informed consent. We hope to include patients of different ages, genders, and health conditions to ensure the wide applicability of the study results. Your participation will help us test and improve the autonomous ultrasound robot so that it can work effectively in a variety of populations.

Brief summary: The purpose of this clinical trial is to verify the safety and effectiveness of the remote automatic ultrasound diagnosis system produced by Wuhan Cooper Technology Co., Ltd. for automatic ultrasound examination. It aims to answer the main questions:

Can the robot complete automatic ultrasound scanning of multiple systems and organs such as liver, gallbladder, spleen, pancreas, kidney, thyroid, carotid artery, etc.? Will there be medical safety issues during the robot\&#39;s scanning process?


Eligibility criteria: Inclusion Criteria:

* 1) Aged ≥ 18 years old, regardless of gender; 2) Those who need to undergo ultrasound examination; 3) Those who voluntarily participate in this trial and sign the informed consent form.

Exclusion Criteria:

* 1) Those who are allergic to ultrasound coupling agents; 2) Those who are unable to undergo long-term ultrasound examinations due to physical or mental reasons (such as intellectual disability, mental illness, etc.); 3) Those who have suffered severe trauma or burns within the past month; 4) Pregnant or breastfeeding women; 5) Those who have participated in other clinical trials within the past month; 6) Other subjects deemed by the researchers to be unsuitable for participating in the trial.

Primary outcomes:
measure: Image scanning pass rate
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Xin-Wu Cui
state: Hubei
Study officials:
References:
Clinical trial NCT01967212: Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
Official title: Swallowing Training Combined With Game-based Biofeedback in Post-stroke Dysphagia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Keywords: stroke
swallowing training
game-based
biofeedback
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.

Detailed description: Swallowing maneuvers are very effective if done correctly, but to evaluate the use of force and the extent of laryngeal elevation is very difficult.

The therapist often requests the patient to "swallow hard" or "maintain laryngeal elevation". However, it is difficult to provide appropriate feedback to the patient, because it's hard to see the throat muscle contraction and bone displacement,the real point of the force is not clear, only oral and tactile feedback is inadequate and when combined with sensory loss, fatigue or cognition impairment.

Biofeedback is defined as "the technique of using equipment (usually electronic) to reveal internal physiological events by visual and auditory signals, to teach patients to manipulate the intrinsic physiological activity (Basmajian, 1989).The rationale is thus that if a patient sees his muscle activity, rather than just feels his muscles contract, he will be able to contract his muscles more fiercely and therefore he will be able to train his muscles faster.

Past studies have shown that biofeedback can help nerve injury patients control their physiological activities such as swallowing training.

The purpose of this study is to determine whether swallowing training combined with game-based biofeedback is effective in the treatment of dysphagia due to stroke.

Eligibility criteria: Inclusion Criteria:

* stroke
* above 18 years-old
* pharyngeal stage dysphagia

Exclusion Criteria:

* on trachea
* cannot follow one command

Primary outcomes:
measure: Hyoid bone displacement on the ultrasound
timeFrame: 6-8 weeks
Secondary outcomes:
measure: Swallow functional ability on the Functional Oral Intake Scale
timeFrame: 6-8 weeks
Other outcomes:
measure: SWAL-QOL Questionnaire
timeFrame: 6-8 weeks
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation,National Taiwan University Hospital
name: Tyng Guey Wang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06577012: Potential Risk Factors and Predictive Model Construction of OBL During SMILE
Official title: Predicting an Opaque Bubble Layer During Small-Incision Lenticule Extraction Surgery Based on Deep Learning
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Small-incision Lenticule Extraction (SMILE) Surgery
Keywords: small-incision lenticule extraction (SMILE)
artificial intelligence
opaque bubble layer
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 4678
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University

Brief summary: To explore the prediction of OBL by deep learning model in SMILE surgery

Detailed description: The DL model was used to predict the OBL area during SMILE surgery by identifying the corneal full-view images before laser scanning. The DL model developed may assist surgeons to predict the possible OBL area of patients in advance, so as to adjust some surgical parameters and reduce the formation of OBL, which can avoid negative effects on surgeons' operation and patients' postoperative visual recovery, which has important practical significance.

Eligibility criteria: Inclusion Criteria:

* A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
* Age ≥18 years;
* Spherical equivalent (SE) ≥ -10.0D;
* Corrected distance visual acuity (CDVA) ≥ 16/20;
* Stable myopia for at least 2 years;
* No contact lenses wearing for at least 2 weeks

Exclusion Criteria:

* The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
* A history of eye surgery;
* The presence or history of systemic diseases.

Primary outcomes:
measure: The area of patients with opaque bubble layer in the SMILE surgeries
timeFrame: Day 0
Secondary outcomes:
measure: Deep learning model
timeFrame: Day 0
measure: ResNet model
timeFrame: Day 0
measure: Vgg19 model
timeFrame: Day 0
measure: U-net model
timeFrame: Day 0
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
References: