louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04022044: Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery
Official title: Postoperative Changes in Head and Neck Cancer Patients Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with head and neck cancer planned for an elective major surgery

Brief summary: The aim of this study is to evaluate the postoperative changes after a major surgery in head and neck cancer patients. Each participant will be evaluated three times: (1) One day before surgery; (2) one month postoperative and (3) three months postoperative. Assessments included blood pressure, anthropometric measurements, physical measurements and questionnaires on quality of life, nutritional status and cancer symptoms.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of head and neck cancer patients planned for an elective major surgery
* More than 18 years of age
* Able to read, write and understand French

Exclusion Criteria:

- Neurological or orthopedic impairments not suitable for testing

Primary outcomes:
measure: Change in functional exercise capacity
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
Secondary outcomes:
measure: Change in muscle fatigability
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in flexibility
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in flexibility
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in upper body strength and endurance
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in hand grip strength
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in health-related quality of life
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in common symptom batteries in cancer patients
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in nutritional status
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in blood pressure
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in weight
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in fat body mass
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
measure: Change in waist circumference
timeFrame: Assessments one day before surgery, 1 and 3 months postoperative
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03925844: Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years
Official title: Cardiovascular Risk in People Older Than 55 Years and Cognitive Performance at 5 Years: an Estimation Model Based on Spanish Population. NEDICES-2-RISK Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Risk Factor, Cardiovascular
Cognitive Decline
Keywords: Cardiovascular risk prediction models
Framingham risk function
FRESCO risk function
risk function
cognitive aging
prevention
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
First posted: 2019-04-24
Enrollment: 965
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comes from the cohort NEDICES 2. NEDICES 2 population comes from primary care physician´s lists.

Brief summary: This study assesses whether people's cardiovascular risk influences cognitive performance in later years. To do this, the cardiovascular risk and cognitive performance of each patient will be evaluated at the beginning of the study and 5 years later.


Eligibility criteria: Inclusion Criteria:

* population aged 55 to 74 years from NEDICES 2 study
* to have signed informed consent
* to have done the neuropsicological assessment

Exclusion Criteria:

* to have a dementia diagnosis at baseline.

Primary outcomes:
measure: Change in the 37-item versión of the Mini-Mental State Examination score
timeFrame: Baseline and 5 years
measure: Change in the Clock-drawing test score
timeFrame: Baseline and 5 years
measure: Change in the Center for Epidemiologic Studies Depression Scale (CES-D) score
timeFrame: Baseline and 5 years
measure: Change in the Semantic verbal fluency test score
timeFrame: Baseline and 5 years
measure: Change in the Six-object memory recall test score
timeFrame: Baseline and 5 years
measure: Change in the Mental Function Index score
timeFrame: Baseline and 5 years
measure: Change in the Trail Making Test score
timeFrame: Baseline and 5 years
measure: Change in the Word accentuation test score
timeFrame: Baseline and 5 years
Secondary outcomes:
measure: New cases of cancer during the 5-years follow-up
timeFrame: 5 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Gerencia Atencion Primaria
Study officials:
affiliation: Gerencia de Atención Primaria, Madrid
name: Ester Tapias-Merino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hernandez-Gallego J, Llamas-Velasco S, Bermejo-Pareja F, Vega S, Tapias-Merino E, Rodriguez-Sanchez E, Boycheva E, Serrano JI, Gil-Garcia JF, Trincado R, Sanchez-Rodrigo JV, Cacho J, Contador I, Garcia-Ptacek S, Sierra-Hidalgo F, Cubo E, Carro E, Villarejo-Galende A, Garcia Garcia-Patino R, Benito-Leon J. Neurological Disorders in Central Spain, Second Survey: Feasibility Pilot Observational Study. JMIR Res Protoc. 2019 Jan 10;8(1):e10941. doi: 10.2196/10941.
Clinical trial NCT06577844: Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients
Official title: Evaluation of the Contribution of a DEMaterialized VIdeo-pedagogical SUpport in the Care Pathway of Lung Cancer Surgery Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: lung cancer
surgery
anxiety
video support
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Uni-centric, randomized, open-label, prospective interventional-comparative study, with a control arm (patients receiving standard preoperative information) and an experimental arm (patients receiving standard preoperative information and having access to a dematerialized educational video support).


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or over,
* Patients requiring surgical management:

for therapeutic purposes (in the case of proven tumor histology) or for diagnostic and therapeutic purposes (in the absence of proven histology, but strong suspicion, after validation by RCP),

- Patients who have given their consent.

Exclusion Criteria:

* Patients under guardianship
* Patients with a history of thoracic surgery
* Patients on long-term analgesic medication
* Patients who do not speak French
* Patients unable to read or write
* Patients with major visual impairment
* Patients with chronic anxiety or depression at the time of admission
* Patients under guardianship
* Pregnant or breast-feeding women

Primary outcomes:
measure: Immediate pre-operative anxiety
timeFrame: 10 days
Secondary outcomes:
measure: Perioperative anxiety (randomization (consultation), immediate postoperative and discharge)
timeFrame: 90 days
measure: Post-traumatic stress disorder
timeFrame: 90 days
measure: Quality of life evaluation
timeFrame: 90 days
measure: Cumulative postoperative morbidity
timeFrame: 90 days
measure: Intra-hospital consumption of analgesics
timeFrame: 90 days
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance publique Hopitaux de Marseille - Hopital Nord
Study officials:
References:
Clinical trial NCT05966844: Golden Age: Virtual Reality and Mindfulness
Official title: Golden Age: Virtual Reality and Mindfulness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Wellbeing
Healthy Lifestyle
Keywords: healthy lifestyle
psychological wellbeing
Lead sponsor: Idego srl
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 40
Sex: ALL
Minimum age (years): 64
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The project will investigate the effects of a Mindfulness pathway in RV on factors that hinder the adoption of healthy eating behaviour in the elderly population. Six meetings of about 5-10 minutes each, one per week, are planned. A randomised controlled trial (RCT) is proposed with two groups:

* An experimental group of 20 elderly people who will do the trial in the RV.
* Another control group, again of the same size, which will simply fill out simply twice the same battery of tests: one at the beginning of the project and the other at the end.
Primary purpose: PREVENTION

Brief summary: The aim of the research is to identify innovative methodologies to improve the psychological well-being of ageing people.

Detailed description: With regard to the objectives of the Golden Age project, a software of Immersive Virtual Reality (VR) for people over 65. The application aims to improve the psychological wellbeing of ageing people, facilitating the removal of barriers that may represent a risk factor with respect to the assumption of a healthy and correct nutrition.

In particular, the elderly will be exposed to naturalistic scenarios in Virtual Reality combined with Mindfulness audio tracks. The practice of Mindfulness in Virtual Reality will be used to prevent and intervene on depressive symptoms, stress and anxiety, which represent the main obstacles to the adoption of healthy behaviours in the elderly person.

Eligibility criteria: Inclusion Criteria:

* Average age over 64
* MMSE between 20 and 30
* Adequate vision and hearing to see scenarios and hear tracks
* sufficient ability to understand procedures and communicate with staff

Exclusion Criteria:

* High levels of depression combined with other psychological risk indices (such as suicidal thoughts)
* Current use of narcotics or substance abuse

Primary outcomes:
measure: Change in levels of GAD-7 test scores
timeFrame: Two months
measure: Change in levels of PHQ-9 test scores
timeFrame: Two months
measure: Change in Perceived Stress Scale test scores
timeFrame: Two months
measure: Change in Mindful Awareness Attention Scale scores
timeFrame: Two months
Secondary outcomes:
measure: Level of acceptance and usability of devices
timeFrame: Two months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Idego srl
Study officials:
affiliation: Idego srl
name: Lorenzo Di Natale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03412344: Factors Influencing Cancer Patients Participation in Clinical Trials in China.
Official title: Assessing Knowledge and Affecting Factors Associated With Cancer Patients Participation in Clinical Trials in China.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: clinical trial
patient
questionnaire
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2018-01-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese patients with a diagnosis of cancer who have joined cancer clinical trial.

Brief summary: This research studies factors affecting Chinese patient participation in cancer clinical trials and their knowledge regarding clinical trials. The investigators design this study to determining how patients makes decisions about participating in a clinical trial and know about patients' attitude toward clinical trials. The investigators aim to find ways to make cancer clinical trials in China more efficient and satisfied patients participating in clinical trials in China.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of malignancy
* Aged 18 years or older
* Ability to understand and complete the questionnaire independently or with the help of a relative or staff member of the oncology department
* Patients have been consented to join an oncology treatment clinical study and have begun active treatment of an oncology clinical trial

Exclusion Criteria:

• Not meeting all eligibility criteria

Primary outcomes:
measure: The patient related factors and the doctor related factors that influence patient decision regarding participation in a cancer clinical trial will be explored by questionnaire.
timeFrame: 1 year
Secondary outcomes:
measure: Oncology patients' understanding and attitude of clinical trials towards cancer clinical research will be evaluated by questionnaire.
timeFrame: 1 year
measure: The actual experience of participants in a cancer clinical trial will be investigated by questionnaire.
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Yuankai Shi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jiang S, Liu P, Yang S, Yang J, Wu D, Fang H, Qin Y, Zhou S, Xu J, Sun Y, Mo H, Gui L, Xing P, Lan B, Zhang B, Tang L, Sun Y, Shi Y. Evaluating stress, satisfaction and the associated influencing factors of participants in cancer clinical trials: a cross-sectional study in China. BMJ Open. 2019 Jun 1;9(5):e028589. doi: 10.1136/bmjopen-2018-028589.
Clinical trial NCT06172244: Acute Effect of Whole Body Vibration on Reaction Speed and Proprioception
Official title: Acute Effect of Whole Body Vibration on Reaction Speed and Proprioception in the Upper Extremity in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whole Body Vibration
Keywords: whole body vibration
healthy subject
reaction time
proprioception
Upper Extremity
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2023-12-15
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A total of 5 sets of vibration will be given at 30 Hz, 2 mm amplitude, 1 minute of application and 1 minute of rest.
Primary purpose: BASIC_SCIENCE

Brief summary: It will be determined whether the application of whole body vibration has an immediate effect on upper extremity reaction speed and proprioception.

Detailed description: Muscles and tendons are among the mechanisms affected by whole body vibration. In this way, it is thought that TVV indirectly affects the reaction speed of individuals. In the light of this information, this study was planned to investigate how whole body vibration application affects proprioception and reaction speed. The reaction rate and instantaneous effect of the virion given at 30 Hz and 2 mm amplitude in the push-up position on proprioception will be investigated. The aim of this study is to investigate the instantaneous effect of whole body vibration on reaction speed and proprioception in the upper extremity in healthy individuals.

Eligibility criteria: Inclusion Criteria:

* Healthy individuals between the ages of 18-25
* Those who do not have any orthopedic problems in the upper extremity
* Individuals without any neurological problems
* Those who volunteer to participate in the study

Exclusion Criteria:

* Those who have vertigo

Primary outcomes:
measure: Nelson Hand Reaction Test
timeFrame: All measurements take 30 minutes for each individual, before and immediately after the application on the same day.
measure: Reaction Rate Evaluation with Sway Medical Smartphone Application
timeFrame: All measurements take 30 minutes for each individual, before and immediately after the application on the same day.
measure: Upper extremity proprioception measurement
timeFrame: All measurements take 30 minutes for each individual, before and immediately after the application on the same day.
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep İslamic Science and Technology University
state: Şahinbey
Study officials:
affiliation: Gaziantep İslamic Science and Technology University
name: Çağtay MADEN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06900244: Metabolic Imaging of Neurological Disease
Official title: Probing Metabolic Dysregulation and Altered Substrate Metabolism in the Healthy and Disrupted Brain Using Hyperpolarised 13C Labelled Substrates.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Multiple Sclerosis
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 250
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers and people with MS / stroke

Brief summary: Multiple Sclerosis is a chronic condition that shows changes in the way that the brain consumes sugar. It is also known that there are a number of metabolic and inflammatory sequelae following a transient ischemic attack/stroke (hereby referred to collectively as 'stroke'). This study will use a powerful new technology ('hyperpolarised magnetic resonance imaging') to detect these changes in the brains of people with multiple sclerosis and Clinically Isolated Syndrome (CIS) or following a stroke when compared to a group of healthy volunteers. It will be undertaken at the University of Oxford, and each participant will undergo up to 4 scans over the course of three years.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MS or stroke

Exclusion Criteria:

-

Primary outcomes:
measure: To detect 13C metabolism in healthy participants and MS, CIS, and Stroke patients.
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
References:
Clinical trial NCT01731444: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury
Official title: Phenylephrine Tumescence for Hemostasis in Surgery for Burn Injury - A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Blood Loss, Surgical
Keywords: blood loss
burn
hemostasis
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-11-21
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The standard of care for treatment of burn injury is to inject a solution of epinephrine under the skin of the injured site in order to reduce blood loss during skin grafting. This solution of epinephrine has been shown to have effects on the body outside the donor site. Some people have increases in heart rate and blood pressure. We will study the effect of a phenylephrine solution in place of an epinephrine solution to control blood loss. We think that phenylephrine will help decrease blood loss and not change blood pressure or heart rate.

The injured area will be injected under the skin and a skin graft will be taken in the same way as we usually do. The only change will be the use of phenylephrine in the solution instead of epinephrine.

Our goal is to find whether or not phenylephrine or epinephrine solution results in a reduction of blood loss without affecting the rest of the body.


Eligibility criteria: Inclusion Criteria

a) Burn injury requiring debridement and grafting between 5-30% TBSA

Exclusion Criteria

1. Head and neck, hand, foot, or genital burns
2. On anticoagulants (except NSAIDs)
3. On monoamine oxidase inhibitor or tricyclic antidepressant
4. Coronary or peripheral vascular disease
5. History of arrhythmias
6. On a Beta-blocker
7. History of vascular abnormality
8. Hypertension

Primary outcomes:
measure: Mean arterial blood pressure (MAP)
timeFrame: during first 30 minutes
Secondary outcomes:
measure: Blood Pressure
timeFrame: q15 min
measure: Heart Rate
timeFrame: q15 min
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT01041144: Effects of Health Care Provider-mediated, Remote Coaching System Through the PDA-type Glucometer and the Internet on Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lifestyle Intervention
Glucose Control
Internet Communication
Keywords: Diabetes
PDA
Internet
HbA1c
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
Collaborators: name: Ministry for Health Welfare and Family Affairs
First posted: 2009-12-31
Enrollment: 115
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the effectiveness of the new diabetes care delivery system applied to preexisting public health care resources through advanced information technologies such as PDA-type glucometer and the Internet on the glycemic control of type 2 diabetes patients lived in isolated rural area.

The investigators conducted a prospective, randomized, controlled trial in patients with type 2 diabetes for 12 weeks. The intervention group was treated with the new health care delivery system, where diabetes center provided specialized management, mediated by nurse of primary health care posts using the Internet and the PDA-type glucometer, while the control group with conventional health care. HbA1c, fasting plasma glucose and lipids levels were measured at baseline and follow-up.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes patients
* Aged ≥ 40 years
* Baseline HbA1c of 7.0 to 11.0 % who had been already followed up for more than 6 months in the health care post

Exclusion Criteria:

* Participants with diagnosed or suspected disease of the liver, pancreas, endocrine organs, or kidney
* Ischemic heart disease or cerebrovascular disease or a history of such disease
* A creatinine level \> 0.133 mmol/L
* Treatment with an intensified insulin regimens and those unable .

Primary outcomes:
measure: HbA1c
Secondary outcomes:
measure: PP2hr Lipid profile
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Catholic Medical College
name: Kun-Ho Yoon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: