louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06292819: Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices
Official title: Effects of Photobiomodulation on Insomnia in the Elderly: Clinical Trials of Phototherapy Devices
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Photobiomodulation
Keywords: rhythm; light therapy; insomnia; sleep; older
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will recruit 60 participants aged 60 and above, who suffered from insomnia for at least 3 months. Sleep parameters and chronotypes assessed with questionnaires and actigraphy, daytime sleepiness, and biological rhythm (dim light melatonin onset) will be measured. The intervention involves light exposure using a prototype device developed by GCSOL Tech Co., Ltd., a company with expertise in light therapy research and development. Three conditions will be tested (1) bright light; (2) near-infrared light; (3) bright light+ near-infrared light. Data analysis will employ paired t-tests to compare sleep parameters and dim light melatonin onset before and after treatment. Kruskal-Wallis tests and multivariate linear regression will be used to examine differences between intervention groups, controlling for gender and age. Safety analysis will include monitoring adverse events.


Eligibility criteria: Inclusion Criteria:

* Pittsburgh Sleep Quality Index score is 8 or above.
* Early wakening ( 30 minutes before expected), or interruptted sleep for more than 30 minutes, lasting for more than 3 months.

Exclusion Criteria:

* Movement disorder, inability to move independently.
* Skin diseases, skin cancer, photosensitive skin diseases, or taking drugs that may cause photosensitivity (lithium salts, melatonin, antibiotics, A acid).
* Eye diseases such as glaucoma, diabetic retinopathy, and cataracts.
* Bipolar disorder.
* Light-induced epilepsy.
* Sleep disorders such as sleep apnea and involuntary leg twitching.
* Currently taking sedative-hypnotic drugs or receiving other non-drug treatments.
* Beck depression inventory-II score is greater than 13 points.
* Those who use cardiac rhythm regulators or artificial cardiopulmonary pacemakers.
* Acute illness.
* Abnormal blood pressure or fever.
* Pregnancy and pregnant women.
* Special physical abnormalities and sensory nerve abnormalities.
* Infectious diseases.
* Coagulation disorder.

Primary outcomes:
measure: Actigraphy-derived sleep indicators
timeFrame: Baseline and the third week.
measure: Dim-light melatonin onset
timeFrame: Baseline and the third week.
measure: Sleep quality
timeFrame: Baseline and the third week.
measure: Emotional state
timeFrame: Baseline and the third week.
Secondary outcomes:
measure: Daytime sleepiness
timeFrame: Baseline and the third week.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References:
Clinical trial NCT05555719: Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study
Official title: Dentoskeletal Effects of Two Different Fixed Functional Appliances for Correction of Class II Malocclusion: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Class II Malocclusion
Keywords: PowerScope
Mandibular Protraction Appliance
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 16
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 treatment groups, both have class II malocclusion
Primary purpose: TREATMENT

Brief summary: Fixed Functional Appliances comparisons in treatment of orthodontic class II malocclusion cases

Detailed description: Comparison between two types of fixed functional appliances, the first one is the Mandibular Protraction Appliances, while the second one was the PowerScope Appliance.

the treatment duration was 6 months the patients age was considered according to Baccetti et al, CVMI 3,4

Eligibility criteria: Inclusion Criteria:

1. Skeletal and dental class II malocclusion with mandibular retrognathia, SNB\>= 4.
2. Patients in cervical vertebral maturation index 3 -5.
3. Age ranged from 13-16 years.
4. Overjet ≥ 5 mm.
5. Minimum crowding in dental arches requiring no extraction of any permanent teeth (excluding third molars).
6. Good oral hygiene and general health.
7. No previous orthodontic treatment or jaw's surgery.

Exclusion Criteria:

* Class I skeletal malocclusion
* periodontally compromised patient
* patients have systemic diseases interfering with orthodontic treatment

Primary outcomes:
measure: SNA angle (on Cephalometric radiograph)
timeFrame: 6 months
measure: SNB angle (on Cephalometric radiograph)
timeFrame: 6 months
measure: ANB angle (on Cephalometric radiograph)
timeFrame: 6 months
measure: Effective mandibular length (mm) (on Cephalometric radiograph)
timeFrame: 6 months
measure: Mandibular plane angle (on Cephalometric radiograph)
timeFrame: 6 months
measure: Maxillary incisors inclination (angle) (on Cephalometric radiograph)
timeFrame: 6 months
measure: Mandibular incisors inclination (angle) (on Cephalometric radiograph)
timeFrame: 6 months
Secondary outcomes:
measure: Upper lip retrusion (mm) (on Cephalometric radiograph)
timeFrame: 6 months
measure: Lower lip protrusion (on Cephalometric radiograph)
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abubakr Mohamed Fouad
Study officials:
affiliation: Al-azhar university, Cairo - Egypt
name: Abubakr M Fouad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217019: Guidewire-assisted Radial A-line in Neonate and Infant
Official title: Comparison of Radial Artery Cannulation Technique in Pediatric Patients: Direct Versus Guidewire-assisted
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Line
Keywords: Radial Artery
Vascular Catheters
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 90
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In neonate and infant, radial artery cannulation may be challenging and multiple attempts are required because of the small diameter.

The invastigators will compare the success rates of radial arterial cannulation with a guidewire-assisted technique and the direct technique in pediatric patient(\<1yr).


Eligibility criteria: Inclusion Criteria:

* Pediatric patients undergoing general anesthesia with arterial cannulation (for hemodynamic monitoring or blood sampling)

Exclusion Criteria:

* Skin lesion, infection, hematoma, recent cannulation at cannulation site
* Unstable radial pulse (d/t unstable vital sign, or arrhythmias)

Primary outcomes:
measure: success rate at 1st attempt (%)
timeFrame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
Secondary outcomes:
measure: total elapsed time (seconds)
timeFrame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
measure: number of total cannulation attempts (number)
timeFrame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
measure: number of total catheter used (number)
timeFrame: from arterial cannulation to successful invasive BP monitoring (up to 1 hour)
measure: malfunction of arterial line
timeFrame: from the start of invasive BP monitoring until the end of anesthesia (up to 1 day)
measure: complications
timeFrame: from the arterial cannulation until the end of anesthesia (up to 1 day)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
affiliation: Professor
name: Jin-Tae Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Jang YE, Kim EH, Lee JH, Kim HS, Kim JT. Guidewire-assisted vs. direct radial arterial cannulation in neonates and infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):738-744. doi: 10.1097/EJA.0000000000001064.
Clinical trial NCT06977919: NASM OPT for Pectoral Enhancement and Breast Firmness in Non-Athletic Women: An RCT
Official title: Efficacy of a 12-Week NASM Optimum Performance Training Program on Pectoral Muscle Strength, Breast Aesthetics, and Low Back Pain in Non-Athletic Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Low Back Pain
Muscle Weakness
Breast Sagging
Keywords: NASM OPT
Pectoral Muscles
Breast Firmness
Non-Athletic Women
Resistance Training
Lead sponsor: University of Sistan and Baluchestan
Sponsor class: OTHER
First posted: 2025-05-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This RCT investigates a 12-week NASM OPT program targeting pectoral muscle strength, breast aesthetics (firmness, lift, chest circumference), and low back pain in 120 non-athletic women. The intervention group performed structured resistance training, while the control group engaged in general exercise. Outcomes included pectoral strength (dynamometer), aesthetic satisfaction (Likert scale), and functional performance (push-up test).

Detailed description: Participants were randomized to NASM OPT (3 weekly sessions: stabilization, strength, and hypertrophy phases) or general exercise (brisk walking/aerobics). Measurements at baseline and 12 weeks included pectoral strength, chest circumference, low back pain (VAS), and perceived breast aesthetics.

Eligibility criteria: Inclusion Criteria:

* Non-athletic women (no exercise in prior 6 months).
* Interest in improving chest aesthetics.
* No musculoskeletal injuries.

Exclusion Criteria:

* Pregnancy
* Chronic illness
* Exercise contraindications

Primary outcomes:
measure: Pectoral Strength
timeFrame: Baseline, 12 weeks
measure: Perceived Breast Firmness/Lift
timeFrame: Baseline, 12 weeks
measure: Chest Circumference
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Aesthetic Satisfaction
timeFrame: Baseline, 12 weeks (post-intervention)
measure: Functional Performance
timeFrame: Baseline, 12 weeks (post-intervention)
measure: Low Back Pain
timeFrame: Baseline, 12 weeks (post-intervention)
Other outcomes:
Locations:
city: Zahedan
country: Iran, Islamic Republic of
facility: Sport Sciences Department
state: Sistan And Baluchestan
Study officials:
affiliation: Assoc.Prof.Dr.
name: Mohammadreza Rezaeipour, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03599219: Platelet Dysfunction in Blood Donors
Official title: Prevalence of Platelet Dysfunction Inblood With a Bleeding History
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Dysfunction in Blood Donors
Keywords: platelets
bleeding
Lead sponsor: Etablissement Français du Sang
Sponsor class: OTHER
Collaborators: name: University of Marseille
First posted: 2018-07-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective case control
Primary purpose: DIAGNOSTIC

Brief summary: Platelets are circulating blood cells. They bind to each other and to the damaged vessel wall to prevent excessive bllod loss. Unlike quantitative platelet defects, there is no automated, simple test to diagnose qualitative platelets defects. However, these defects expose to bleeding in a surgical situation and could explain the transfusion inefficiency of some platelet concentrates.

In recent decades, considerable progress has been made in understanding qualitative platelet disorders.

In this project, we propose to submit blood donors to a standardized hemorrhagic diathesis questionnaire and to compare the prevalence of platelet function abnormalities in blood donors with and without hemorrhagic diathesis.

Detailed description: Primary objective specify the prevalence of qualitative platelet disorders in blood donors with i) a clinical history of bleeding diathesis collected through a standardized and validated questionnaire ii) and / or a hematoma (more than 4 cm) that occurred during blood donation.

Secondary objectives to obtain the prevalence of other defects of hemostasis

Eligibility criteria: Inclusion Criteria:

- Any male or female volunteer eligible for the blood donation

Exclusion Criteria:

* Subject with contraindications to blood donation:
* weight \<50 kg;
* severe fatigue,
* anemia,
* insulin-dependent diabetes;
* subject treated for epileptic seizures or having followed a treatment whose arrest is less than 14 days old.
* active pregnancy or childbirth less than 6 months old.
* viral disease (eg influenza, gastroenteritis ...) active less than two weeks after the end of symptoms.
* waiting period not respected after certain acts of daily life according to the regulatory criteria set by the EFS
* HIV infection, hepatitis B, hepatitis C

Primary outcomes:
measure: Platelet functions
timeFrame: first visit 1 week
Secondary outcomes:
measure: Exploration of Coagulation
timeFrame: first visit 1 week
Other outcomes:
Locations:
city: Marseille
country: France
facility: Maison Du Don
Study officials:
affiliation: Etablissement francais du sang
name: Picard Christophe, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01029119: Clinical Test for Blood Pressure Meter of CH-101
Official title: Clinical Test of Blood Pressure Meter of CH-101
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Pressure
Keywords: blood pressure
Lead sponsor: Citizen Systems Japan Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 85
Sex: ALL
Minimum age (years): 22
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Blood pressure meter model CH-101 was to be assessed against the standard mercury sphygmomanometer according to the protocol of the ANSI/AAMI SP-10.


Eligibility criteria: Inclusion Criteria:

* 85 subjects with a wide range of blood pressure were selected.

Exclusion Criteria:

* Subjects could be taking antihypertension medication, but excluded in atrial fibrillation or with any sustained arrhythmia.

Primary outcomes:
measure: Measure the accuracy of blood pressure meter model CH-101 assessed against the standard mercury sphygmomanometer according to the protocol of ANSI/AAMi SP-10.
timeFrame: 30 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT02287519: Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention
Official title: Sexual Therapy and Rehabilitation After Treatment for Ovarian Cancer (START-OC): A Pilot Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Patty Brisben Foundation For Women's Sexual Health
First posted: 2014-11-10
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research study is evaluating an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer.

Detailed description: The purpose of this research is to study the effectiveness of an educational intervention for women who have experienced changes in sexual function after treatment for ovarian cancer. The aim is to develop an effective intervention to help women manage these changes and restore sexual health and functioning. This study consists of attending a group educational session followed by a one-on-one telephone counseling session.

Eligibility criteria: Inclusion Criteria:

* Women diagnosed with Stage1-IV ovarian cancer
* Prognosis of at least one year to live (as assessed by provider)
* Endorsement of at least one sexual symptom (see Appendix A for eligibility screening)
* English speaking
* Signed informed consent

Exclusion Criteria:

* History of pelvic radiation
* Cognitive impairment which would interfere with the ability to participate in the study (as assessed by provider)

Primary outcomes:
measure: Change in sexual dysfunction will be assessed by change on the Female Sexual Function Index (FSFI).
timeFrame: Baseline, 2 month Post Intervention, 6 Month Post Intervention
Secondary outcomes:
measure: Change in sexual self-efficacy will be assessed by change on the Sexual Self-Efficacy Scale
timeFrame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
measure: Improvement in sexual knowledge will be assessed by change on the Sexual Knowledge after Ovarian Cancer questionnaire
timeFrame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
measure: Change in psychological distress will be assessed by change on the BSI-18 (Brief Symptom Inventory)
timeFrame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
measure: Feasibility of conducting a group sexual health intervention via webinar format will be assessed with descriptive data and qualitative feedback from participants
timeFrame: Baseline, 2 Month Post Intervention, 6 Month Post Intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Sharon Bober, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02548819: University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
Official title: University Hospital Cardiac Device MR Registry: The Safety of MR Imaging in Patients With Implanted Cardiac Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: MRI
Pacemaker
Defibrillator
Lead sponsor: University Health Care System, Augusta, Georgia
Sponsor class: OTHER
First posted: 2015-09-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who require MR imaging in the presence of a pacemaker or ICD

Brief summary: A single-center registry to prospectively evaluate the safety of non-cardiac/non-thoracic magnetic resonance imaging (MRI) in patients with implanted cardiac devices (pacemakers and implantable cardioverter defibrillators).

Detailed description: Evaluation of safety of MR scanning of patients with implanted cardiac devices. Device parameters pre and post MR imaging will be assessed.

Eligibility criteria: Inclusion Criteria:

* Male or female 18 years or older
* Informed consent can be provided by patient or medical power of attorney
* Presence of implanted pacemaker or ICD
* MRI is the diagnostic modality of choice for a specific clinical scenario without acceptable alternative imaging technology as determined by ordering physician
* Non-cardiac/non-thoracic MRI ordered

Exclusion Criteria:

* Presence of metallic objects that represent a contraindication to MR imaging
* Morbid obesity which results in body contact with the magnet façade
* Pacemaker or ICD generator implanted prior to 2002
* ICD patients who are pacing dependent
* Pregnancy
* Device generator at ERI (elective replacement interval)
* Presence of other active implanted medical device
* Presence of abandoned leads (with the exception of post CABG temporary epicardial pacing wires)
* Presence of implanted cardiac device in the abdominal position
* Pacemaker or ICD that is labeled as MRI-Conditional by the FDA
* Pacemaker or ICD implanted less than 6 weeks prior to MRI scan

Primary outcomes:
measure: Battery voltage
timeFrame: Immediate
measure: Pacing lead impedance
timeFrame: Immediate
measure: Shock impedance
timeFrame: Immediate
measure: P wave amplitude
timeFrame: Immediate
measure: R wave amplitude
timeFrame: Immediate
measure: Pacing lead threshold
timeFrame: Immediate
measure: Adverse event
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Augusta
country: United States
facility: University Hospital
state: Georgia
Study officials:
affiliation: University Hospital
name: Patrick M Aquilina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175719: Post-marketing Surveillance of Administration of Botulinum Toxin Type B(NerBloc)-Investigation of the Clinical Condition in Patients With Change From Botulinum Toxin Type A
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Keywords: Torticollis
rimabotulinumtoxinB
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cervical dystonia who was treated by botulinum toxin type A in the past.

Brief summary: Investigation of the clinical condition in patients with cervical dystonia by Toronto Western Spasmodic Torticollis Scale (TWSTRS)


Eligibility criteria: Inclusion criteria:

Patients with cervical dystonia who was treated by botulinum toxin type A in the past.

Patients who was enrolled in NB01S and was evaluated by TWSTRS at the first injection of NerBloc.

Primary outcomes:
measure: Whole improvement level
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Akira Endo
role: STUDY_DIRECTOR
References: