louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04970433: The Effects of Acupuncture for Major Trauma
Official title: The Effects of Electroacupuncture and Laser Acupuncture Therapy for Patients With Major Trauma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Trauma
Keywords: major trauma
acupuncture
laser acupuncture
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Major trauma is a significant cause for morbidity and mortality in the world. After traumatic injury, the damage tissue could induce systemic inflammatory response (SIRS) and activate autonomic nervous system in response to stress, followed by compensatory anti-inflammatory response (CARS). Imbalance of SIRS and CARS may lead to organ failures, sepsis and death.

Detailed description: The investigators design a prospective clinical trial to investigate the efficacy of acupuncture for major trauma.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 20 years or older
* Confirmed diagnosis of major trauma with ISS ≥ 16

Exclusion Criteria:

* Pregnancy
* Malignancy
* Pacemaker
* Status epilepticus
* Severe medical disease
* Life threatening
* Prior history of drug or alcohol dependence
* Immunodeficiency
* Vagotomy

Primary outcomes:
measure: Length of hospital stay
timeFrame: up to 24 weeks
Secondary outcomes:
measure: CRP
timeFrame: measured at 48 hours, 7 days and 14 days
measure: IL-6
timeFrame: measured at 48 hours, 7 days and 14 days
measure: TNF-α
timeFrame: measured at 48 hours, 7 days and 14 days
measure: IL-1β
timeFrame: measured at 48 hours, 7 days and 14 days
measure: IL-10
timeFrame: measured at 48 hours, 7 days and 14 days
measure: Sequential organ failure assessment (SOFA) score
timeFrame: measured at 48 hours, 7 days and 14 days
measure: WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version
timeFrame: measured at 3 and 6 months
measure: Peripheral Blood Mononuclear Cell (PBMC) analysis
timeFrame: measured at 48 hours, 7 days and 14 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chun-Ting Liu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu CT, Hsieh TM, Shih FY, Lai WH, Hsieh CH, Wu BY, Chen YH. The effects of electroacupuncture and laser acupuncture therapy for patients with major trauma: A study protocol. Medicine (Baltimore). 2021 Dec 30;100(52):e28367. doi: 10.1097/MD.0000000000028367.
Clinical trial NCT01466933: Responsive Parenting Program for Infants in Rural Bangladesh
Official title: Design, Implementation and Evaluation of a Parent Support/Counselling Program With a Focus on Responsive Stimulation for Infants and Young Children in Rural Bangladesh
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: parenting intervention
child development
low and middle income countries
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Save the Children
First posted: 2011-11-08
Enrollment: 474
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Children of mothers in the intervention parenting program are expected to show benefits over the standard care control group in terms of better cognitive/language development, less recent illness, and better height for age. The mothers assigned to the intervention parenting program are expected to evidence higher levels of home stimulation, better health prevention, and better dietary diversity, along with more accurate knowledge of child development.

Detailed description: There are actually two intervention groups: in one the program is delivered by trained peer educators from the village, and in the other the program is delivered by trained government personnel.

Eligibility criteria: Inclusion Criteria:

* mother has a child 6 to 14 months of age
* mother willing to learn about child care

Exclusion Criteria:

* not severely disabled

Primary outcomes:
measure: Bayley scales of infant development
timeFrame: 12 months
Secondary outcomes:
measure: HOME Inventory
timeFrame: 12 months
measure: Mother-Child picture talk
timeFrame: 12 months
measure: Dietary diversity
timeFrame: 12 months
measure: Child development knowledge of mother
timeFrame: 12 months
measure: height for age
timeFrame: 12 months
Other outcomes:
Locations:
city: Kushtia
country: Bangladesh
facility: Save the Children district office
Study officials:
affiliation: McGill University
name: Frances Aboud, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00074633: Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model
Official title: Evaluating "Health at Every Size"(HAES) as an Alternative Obesity Treatment Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Hypertension
Depression
Diabetes Mellitus, Type 2
Keywords: Type 2 Diabetes
Self-Esteem
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
Collaborators: name: University of California, Davis
name: United States Department of Agriculture (USDA)
First posted: 2003-12-19
Enrollment: 79
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Increasingly more individuals are trying to lose weight. Indeed, many women, regardless of their size, experience a life-long battle and preoccupation with their weight. Despite the attention to weight and the increase in diet behavior, the incidence of obesity continues to rise. There is little data to show improved long term success for the majority of participants who engage in weight loss behaviors.

The specific aim is to improve the psychological and metabolic health of obese women with a history of chronic dieting through encouraging "Health at Every Size" (HAES). This treatment model emphasizes "intutitive eating," i.e., internal regulation of eating (responding to cues of hunger, appetite and satiety). The HAES model is being compared to the current standard of care in obesity treatment, energy restriction dieting, which encourages cognitive control of eating and weight reduction.


Eligibility criteria: * Caucasian;
* female;
* age 30-45 years;
* Body Mass Index (BMI)\>30 m/kg2;
* non-smoker;
* not pregnant or lactating;
* Restraint Scale (Herman and Polivy, 1988) score \>15, indicating a history of chronic dieting;
* no recent myocardial infarction;
* no active neoplasms, Type 1 diabetes or insulin-dependent Type 2 diabetes, nor history of cerebrovascular or renal disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Davis
country: United States
facility: Nutrition Department, University of California, Davis
state: California
city: Davis
country: United States
facility: Western Human Nutrition Research Center
state: California
Study officials:
References:
citation: Bacon L, Keim NL, Van Loan MD, Derricote M, Gale B, Kazaks A, Stern JS. Evaluating a 'non-diet' wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors. Int J Obes Relat Metab Disord. 2002 Jun;26(6):854-65. doi: 10.1038/sj.ijo.0802012.
Clinical trial NCT05768633: Counterfactual Thinking and Decision-making in OSA Syndrome
Official title: Counterfactual Thinking About Clinical Decision and Decision-making in the Context of Obstructive Sleep Apnea Syndrome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: counterfactual thinking
decision-making
neuropsychological assessment
clinical setting
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with obstructive sleep apnea syndrome consecutively recruited at the beginning of their rehabilitative treatment at the IRCCS Istituto Auxologico Italiano.

Brief summary: The aim of this research is to verify the ability of counterfactual thinking about medical decisions in individuals with obstructive sleep apnea syndrome when compared with healthy individuals


Eligibility criteria: Inclusion Criteria:

- Diagnosis of obstructive sleep apnea syndrome, according to the clinical assessment.

Exclusion Criteria:

- Concurrent neurological, neurodevelopmental (e.g., autism), motor, and/or psychiatric disorders

Primary outcomes:
measure: CIT score
timeFrame: Baseline
Secondary outcomes:
measure: Decision-making index
timeFrame: Baseline
Other outcomes:
Locations:
city: Piancavallo
country: Italy
facility: IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
state: VCO
Study officials:
affiliation: IRCCS Istituto Auxologico Italiano
name: Sofia Tagini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01616433: Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging--Prevention Research Center
Official title: Arthritis Foundation Exercise Program & "10 Keys" to Healthy Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arthritis
Diabetes
Hypertension
Preventive Behaviors
Keywords: Arthritis
Preventive Behaviors
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Arthritis Foundation
First posted: 2012-06-11
Enrollment: 462
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Older adults are at high risk for loss of independence because of age-related chronic health conditions. Of these chronic conditions, arthritis accounts for the largest proportion of the disability in the community. The investigators propose to target older adults who have self-reported arthritis or joint pain for dissemination of a disability prevention program. The program will be a collaborative effort of the Arthritis Foundation, the investigators Prevention Research Center staff and other key partners in the community. The project will develop information needed to provide guidance for implementation of the investigators intervention by other agencies and organizations. As a major thrust of the investigators CDC Prevention Research Center, the investigators have developed a comprehensive program focused on preventing disease and disability in older adults: the "10 Keys to Healthy Aging". Each of the 10 Keys disseminates proven approaches and current recommendations for prevention in older adults, focusing on age 65+ but also addressing age 50-65 years. The overall objective is to determine if an integrated evidence based exercise intervention (AFEP) combined with health education on preventive practices for older adults ("10 Keys") is more effective for improving mobility and risk factors for mobility disability and use of preventive services compared to exercise alone (AFEP). The investigators will also propose to evaluate the impact of geographic location on outcomes and overall sustainability of the program.


Eligibility criteria: Inclusion Criteria:

* 50+ years old
* Attends at last one exercise class in a 10 week program

Exclusion Criteria:

* On oxygen
* Hospitalized for cardiac event in past 6 months (at least 1 overnight)
* Had major surgery in past 6 months

Primary outcomes:
measure: Preventive Behaviors
timeFrame: 1 year
measure: Joint Pain & Stiffness
timeFrame: 1 year
measure: Cholesterol (LDL)
timeFrame: 1 year
measure: Glucose
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Allegheny County primarily
country: United States
facility: Community sites
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02037633: Analgesia for Positioning Hip Fracture Patients for Spinal Anesthesia
Official title: Fascia Iliaca Compartment Block Versus Fentanyl for Positioning Patients With Hip Fractures for Central Nervous Blockade: a Randomized Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
First posted: 2014-01-16
Enrollment: 41
Sex: ALL
Standard ages: CHILD
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 two analgesic methods performed preoperatively to assist positioning patients for performance of spinal anesthesia, namely fascia iliaca blockade and intravenous fentanyl.


Eligibility criteria: Inclusion Criteria:

* Hip fracture

Exclusion Criteria:

* contraindications for central nervous blockade
* impaired cognition or dementia
* multiple fractures
* any previous analgesic administration during the last 12 hours

Primary outcomes:
measure: Pain scores on the Numeric Rating Scale
timeFrame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Secondary outcomes:
measure: Duration of spinal anesthesia performance
timeFrame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
measure: Quality of patient's position
timeFrame: Group A: 5 minutes after intervention (fentanyl), Group B: 20 minutes after intervention (block)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
state: Attica
Study officials:
References:
citation: Yun MJ, Kim YH, Han MK, Kim JH, Hwang JW, Do SH. Analgesia before a spinal block for femoral neck fracture: fascia iliaca compartment block. Acta Anaesthesiol Scand. 2009 Nov;53(10):1282-7. doi: 10.1111/j.1399-6576.2009.02052.x. Epub 2009 Jul 22.
citation: Hogh A, Dremstrup L, Jensen SS, Lindholt J. Fascia iliaca compartment block performed by junior registrars as a supplement to pre-operative analgesia for patients with hip fracture. Strategies Trauma Limb Reconstr. 2008 Sep;3(2):65-70. doi: 10.1007/s11751-008-0037-9. Epub 2008 Sep 2.
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.
Clinical trial NCT05808933: Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer
Official title: Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of cervical cancer (FIGO IA-IIA) that will undergo to surgery at Fondazione Policlinico Universitario "A. Gemelli" IRCCS can be included in this study, according to inclusion and exclusion criteria

Brief summary: The aim of this observational prospective study is to investigate the role of Magnetic Resonance Fingerprinting in preoperative assessment of early cervical cancer


Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven cervical cancer FIGO stage IA-IIA undergoing surgery;
* Women aged \>18 years old;
* Signed Informed Consent.

Exclusion Criteria:

* Concurrent malignancies at other sites;
* Previous history of neoplasm;
* Refusal to sign written informed consent

Primary outcomes:
measure: Association between T1-, T2- and ADC-maps and LVSI status
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between T1-, T2- and ADC-maps and DFS and OS
timeFrame: 3 years
measure: Correlation between Radiomics-based analysis and LVSI status and DFS and OS
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitaro "A. Gemelli" IRCCS
Study officials:
References:
Clinical trial NCT06080633: Facial Prediction Technology for Edentulous Patients
Official title: Research on Facial Prediction Technology for Edentulous Implant-Supported Fixed Prostheses Based on Multimodal Data Fusion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Edentulous Jaw
Keywords: Edentulous Jaw
deep learning
oral implantology
facial prediction
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2023-10-12
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient with Edentulous Maxilla after Implant Prosthetic Restoration

Brief summary: According to data from the World Health Organization, approximately 160 million people worldwide are edentulous. The incidence increases with age, and the proportion of edentulous patients is higher in the population aged 60 and above. Loss of teeth or edentulism can affect facial appearance, causing people to feel self-conscious and loss confidence in social situations, and even lead to psychological illnesses. Therefore, edentulous patients not only pay close attention to the recovery of oral function but also attach great importance to facial contour improvement. For a long time, due to technological limitations, clinicians have been unable to depict the changes in facial contour after implant placement for patients before surgery. However, with the development of artificial intelligence technology, deep learning-based methods for predicting soft tissue facial deformation have made this mission a possibility. This study established a multi-modal dataset for edentulous patients before and after implant restoration to lay the foundation for predicting facial contour changes after implant treatment. A graph generative adversarial network based on multi-modal data was proposed to achieve fast and high-precision facial contour prediction. To address the common challenges of slow computation and excessive computational resource consumption in current triangular mesh deformation simulation methods, this project innovatively proposed a graph generative adversarial network that uses multi-modal data and incorporates self-attention mechanisms to achieve fast and high-precision facial contour prediction for edentulous patients after implant restoration.


Eligibility criteria: Inclusion Criteria:

* Patients with complete edentulism,
* aged 50 years or above,
* in good physical health,

Exclusion Criteria:

* patients who refuse to participate in the study，
* patients who cannot undergo facial scanning.

Primary outcomes:
measure: Changes in Soft Tissue Volume in the Lip Region after Implant Dentistry
timeFrame: Between pre-operation and after Implant-Supported Fixed Prostheses up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Hongyang Ma
state: Heverlee
Study officials:
References:
Clinical trial NCT05789433: Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Official title: Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colonic Neoplasms
Rectal Neoplasms
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Histologically confirmed stage I, II, or III colon or rectal cancer
* Completed surgical resection with curative intent
* Completed other cancer-directed treatments
* Engage in \<150 minutes per week of moderate- to vigorous-intensity structured endurance exercise
* No planned major surgery during the study period
* Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
* Ability to provide written informed consent
* Provide written approval by a qualified healthcare professional
* Willing to be randomized

Exclusion Criteria:

* Evidence of metastatic or recurrent colorectal cancer
* Concurrently actively treated other (non-colorectal) cancer
* Scheduled to receive other postoperative cancer-directed treatment(s)
* Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
* Currently participating in another study with competing outcomes
* Contraindications to magnetic resonance imaging
* Any dietary condition or restriction that would limit tolerance of a mixed meal challenge
* Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
* Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Primary outcomes:
measure: Whole-Body Intermuscular Adipose Tissue
timeFrame: up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Justin C. Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: