louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05661838: Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications
Official title: Effect of Intraoperative Allogeneic Blood Transfusion on Postoperative Pulmonary Complications in Elective Spinal Surgery: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Fusion
Transfusion
Pulmonary Complication
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 272
Sex: ALL
Minimum age (years): 9
Maximum age (years): 82
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were included if they underwent post vertebral column resection (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020

Brief summary: Elective spine surgery is associated with a high incidence of perioperative complications, including peri- and postoperative pulmonary complications (PPCs), which occur in nearly 4% of patients. More than 40% of all deaths after elective spine surgery are attributed to PPCs. However, whether it influences risk of other PPCs is unclear.


Eligibility criteria: Inclusion Criteria:

* Patients were included if they underwent elective spine surgery (e.g. multi-segmental thoracic, lumbar, or thoracolumbar spine surgery) at the Second Hospital of Zhejiang University School of Medicine from August 1, 2013 to October 31, 2020

Exclusion Criteria:

* combined anterior-posterior surgery
* growth rod adjustment surgery
* spinal tumor.
* surgery took fewer than 3 hours.

Primary outcomes:
measure: Correlation between blood transfusion and postoperative pulmonary complications
timeFrame: 28 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University anesthesiology department
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital of Zhejiang University Medical College
name: Min Yan, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT06762938: The Effect of ShotBlocker on Pain and Satisfaction During Measles-Rubella-Mumps Vaccination
Official title: The Effect of ShotBlocker on Pain and Satisfaction During Measles-Rubella-Mumps Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective The aim of this study was to evaluate the effects of ShotBlocker administration during measles-mumps-rubella (MMR) vaccination on infants' pain level and mothers' satisfaction.

Method. The study was conducted in a Family Health Center affiliated to the Public Health Directorate of a province in eastern Turkey between August and October 2024 using a randomized controlled experimental design. The study sample consisted of 60 infants who received MMR vaccination (ShotBlocker group: n = 30, control group: n = 30). Infants in the ShotBlocker group received ShotBlocker before vaccine injection, while infants in the control group received only routine vaccine injection. Infant information form, FLACC pain scale and Newcastle Satisfaction with Nursing Care Scale were used for data collection. Ethical principles were followed throughout the study.


Eligibility criteria: Inclusion Criteria:

* He's 12 months old,
* MMR vaccine will be administered,
* growth-development is normal,
* no analgesic medication was given during the day,
* at least high school graduate
* mothers who volunteered to participate in the study

Exclusion Criteria:

* Neurological disease,
* a chronic disease,
* allergy (egg allergy)
* infants with symptoms of hyperthermia

Primary outcomes:
measure: Face, Legs, Activity, Crying, Consolability Pain Scala
timeFrame: pre-test post-test (approximately three months)
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yüzüncü Yıl University
state: Tuşba
Study officials:
References:
Clinical trial NCT05183438: Construction of a Prediction Model for Metachronous Colorectal Adenoma
Official title: Construction of a Prediction Model for Metachronous Colorectal Adenoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metachronous Colorectal Adenoma
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 30000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Confirmed eligible patients, 18 to 75 years of age, including cases with metachronous colorectal adenomas and controls without metachronous colorectal adenomas, are enrolled in this study.

Brief summary: The study aimed to explore the independent risk factors for the metachronous colorectal adenoma after endoscopic resection, and construct the prediction model of metachronous colorectal adenoma, in order to provide theoretical basis for postoperative follow-up time of patients, and allocate limited medical resources.

Detailed description: A large cohort of eligible patients were included in the analysis, and classified into derivation and validation cohorts at a ratio of 7:3. Demographic and clinicopathological characteristics of participants were utilized to develop a prediction model for metachronous colorectal adenoma. In the derivation cohort, the LASSO regression method was applied to filter variables and multivariate logistic regression analysis was used to identify important predictors.A prediction model was established based on the results of multivariate logistic regression analysis. The predictive performance of the model was evaluated with respect to its discrimination, calibration and clinical usefulness.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 and ≤75 years old. Patients with complete data on demography and clinicopathology.

Exclusion Criteria:

* Patients with a history of inflammatory bowel disease, enterophthisis, familial adenomatous polyposis, P-J syndrome and intestinal lymphoma.

Patients with a previous history of colorectal neoplasm. Patients with a history of severe systemic diseases. Lack of complete clinical data for analysis.

Primary outcomes:
measure: Demographic characteristics of patients with metachronous colorectal adenomas checklist
timeFrame: 3 year
Secondary outcomes:
measure: Cumulative recurrence rate of metachronous colorectal adenomas
timeFrame: 3 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References:
citation: Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2020 Mar;158(4):1131-1153.e5. doi: 10.1053/j.gastro.2019.10.026. Epub 2020 Feb 7. No abstract available.
Clinical trial NCT05980338: Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis
Official title: Comparative Study Between Knee Genicular Nerve Ablation by Thermal Radiofrequency vs Thermal Radiofrequency Plus Alcohol Neurolysis for Treatment of Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 52
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: the aim of our study is to compare effectiveness (satisfaction) and duration of pain relief between patients receiving the conventional thermal radiofrequency on the genicular nerves alone vs patients who will receive the conventional method plus alcohol neurolysis of the targeted nerves.


Eligibility criteria: Inclusion Criteria:

1. Both genders.
2. Age between 60-70 years.
3. ASA 1,2 \& 3 physical status.
4. x ray imaging confirming the osteoarthritis and unwell or not candidate for knee replacement surgery

Exclusion Criteria:

1. Neurological disorders.(previous cerebrovascular stroke , neuropathy , or weakness )
2. coagulopathy ( plt \< 50000, INR \> 1.7 )
3. Infection at or near the injection site.
4. presence of pacemaker or defibrillator 5 - Acute knee injury.

6- age \< 60 or \>70 years

Primary outcomes:
measure: pain relief after 1 month
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospital
Study officials:
References:
citation: Kidd VD, Strum SR, Strum DS, Shah J. Genicular Nerve Radiofrequency Ablation for Painful Knee Arthritis: The Why and the How. JBJS Essent Surg Tech. 2019 Mar 13;9(1):e10. doi: 10.2106/JBJS.ST.18.00016. eCollection 2019 Mar 26.
citation: Liu J, Wang T, Zhu ZH. Efficacy and safety of radiofrequency treatment for improving knee pain and function in knee osteoarthritis: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Jan 15;17(1):21. doi: 10.1186/s13018-021-02906-4.
citation: Dass RM, Kim E, Kim HK, Lee JY, Lee HJ, Rhee SJ. Alcohol neurolysis of genicular nerve for chronic knee pain. Korean J Pain. 2019 Jul 1;32(3):223-227. doi: 10.3344/kjp.2019.32.3.223.
Clinical trial NCT02874638: Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes
Official title: Effect of Non-essential Amino Acids on Protein Requirements for Endurance Athletes Using Indicator Amino Acid Oxidation Method.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Metabolic Requirement
Healthy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2016-08-22
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).

The biological value of protein depends on its amino acid composition. Essential amino acids are believed to have main role on whole body protein metabolism. However, it remains to be determined what role non-essential amino acids (NEAA) may have in regulating protein metabolism and contributing to the increased protein requirements after endurance exercise.

The indicator amino acid oxidation (IAAO) method has clarified the individual amino acid requirement in children, normal healthy adult and clinical populations. However, the IAAO method has never been utilized for assessing the effect of NEAA on protein requirements after endurance exercise.

The objective of the current study is to investigate the importance of NEAA for endurance-trained male subjects.


Eligibility criteria: Inclusion Criteria:

* endurance-trained participants who regularly run more than 40 km/week
* Participants who are categorized at least "very good" based on a study by Shvartz \& Reibold, in which VO2peak is used as an index. (i.e. the participants whose VO2peak is ≥57 ml/kg/min (18-24 y), ≥54 ml/kg/min (25-29 y), ≥52 ml/kg/min (30-34 y), ≥49 ml/kg/min (35-39 y)
* Ability to complete the 16-km familiarization run in session 2

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use

Primary outcomes:
measure: 13CO2 (carbon dioxide) excretion rate (μmol/kg/h)
timeFrame: at 8 hours after the end of exercise]
Secondary outcomes:
measure: [13C]phenylalanine oxidation rate (μmol/kg/h)
timeFrame: at 8 hours after the end of exercise
Other outcomes:
Locations:
Study officials:
affiliation: University of Toronto
name: Daniel Moore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05815238: Investigation of the Relationship Between Foot Posture Index Score and Foot Function and Balance Performance
Official title: Investigation of the Relationship Between Foot Posture Index Score and Foot Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Foot Posture Index Score
Keywords: balance
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who will participate in the study will be reached via social media, whatsapp and message.

Brief summary: The foot is a terminal joint that opposes external resistance in the lower kinetic chain. It plays a primary role in weight transfer and ground response between the body and the ground. It plays a role in maintaining an upright posture, lowering the gravitational line against a narrow support surface during walking, providing stability and absorbing the shocks that occur during daily life activities.

Foot problems are common worldwide. These problems affect people negatively by giving symptoms during activities of daily living.

Detailed description: There is not much data on whether these changes are related to age or not. Deformities, kinetic chain disorders, and other problems that affect balance are likely to increase with age. For this reason, in our study, the relationship between foot posture and functional-balance was examined on the basis of age groups.

Body balance may be impaired by deficiencies in the strength and mechanical stability of any joint or structure along the lower extremity kinetic chain, or by decreased afferent feedback. It is necessary to know the foot posture and biomechanics about the causes of injury and susceptibility to injury during activities of daily living and sports.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 20 - 65,
* Volunteer.

Exclusion Criteria:

* Having a musculoskeletal or neuromuscular disease that limits mobility,
* Presence of lower extremity sequelae,

Primary outcomes:
measure: Foot Function Index
timeFrame: 1 day
measure: Foot Posture Index
timeFrame: 1 day
measure: Single Leg Jump Test (TBS)
timeFrame: 1 day
measure: Y Balance Test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: HAZAL genç
Study officials:
References:
Clinical trial NCT02583438: Evaluate the Effect of Saxagliptin on Gut Microbiota in Patients With Newly Diagnosed Type 2 Diabetes
Official title: Beijing Chao-yang Hospital, Capital Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Type 2 Diabetes
Obesity
Keywords: Gut Microbiota
inflammatory marker
Glucose and lipid metabolism
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The intestinal microflora imbalance has been associated with obesity and type 2 diabetes. The researchers' study aimed to investigate the effect of saxagliptin on gut microbiota in patients with newly diagnosed type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Females or males, and aged 20 to 65 years.
* Newly diagnosed type 2 diabetes
* HbA1C ≥7% and HbA1C \<9%

Exclusion Criteria:

* Hepatic insufficiency (ALT or AST\> 1.5\*ULN)
* Renal insufficiency \[Creatinine clearance rate (Ccr)\]\<60ml/min estimated from MDRD equation)
* Coronary artery disease
* Thyroid disease
* Infectious disease
* Systemic inflammatory disease
* Cancer
* Subjects who were taking agents known to influence gut microbiota
* Pregnant or lactating woman
* Other conditions at investigator's discretion

Primary outcomes:
measure: gut microbiota
timeFrame: Change from Baseline Bacteroidetes abundances and composition of gut microbiota at 6 months
Secondary outcomes:
measure: The improvement of intestinal microflora imbalance
timeFrame: Bacteroidetes abundances and composition of gut microbiota (baseline, 4 weeks, 8 weeks and 12 weeks)
measure: The change of inflammatory markers
timeFrame: The change of inflammatory markers (baseline, 12 weeks)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01479738: Proximal Interphalangeal Joint Arthroplasty Using a Graft From the Capitate
Official title: The Second Hospital of Qinhuangdao, Qinhuangdao, Hebei, 066600, China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recurrent Dislocation of Hand
Keywords: arthroplasty
graft
capitate
artery
Lead sponsor: The Second Hospital of Qinhuangdao
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The capitate had a widened distal base. The distal articulation can be used for proximal interphalangeal (PIP) articula reconstruction.

Detailed description: Previous anatomical studies have shown that the capitate had a widened distal base. The distal articulation was mainly with the base of the third metacarpal and partially with the base of the second metacarpal. The articulation was slightly flattened with a convex and concave dorsal articular surface. The contour stimulates our imagination and creativity to use a portion of the articular surface for PIP arthroplasty.

Eligibility criteria: Inclusion Criteria:

1. an articular defect at the proximal aspect of the PIP joint;
2. the defect larger than 5 mm × 5 mm in size based on intraoperative findings.

Exclusion Criteria:

1. large defects involved double joint surfaces;
2. the size of the defect less than 5 mm × 5 mm;
3. mult-digital articular defects that all required osteoarticular grafting;
4. associate with infection or other diseases that restrict to use the technique.

Primary outcomes:
measure: range of motion
timeFrame: 37 to 46 months postoperatively
Secondary outcomes:
measure: grip strength
timeFrame: 37 to 46 months postoperatively
measure: pinch strength
timeFrame: 37 to 46 months postoperatively
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: The second hospital of Qinhuangdao
state: Hebei
Study officials:
affiliation: The Second Hospital of Qinhuangdao
name: Xu Zhang, M.D.
role: STUDY_CHAIR
References:
citation: Freiberg A. Management of proximal interphalangeal joint injuries. Can J Plast Surg. 2007 Winter;15(4):199-203. doi: 10.1177/229255030701500407.
Clinical trial NCT05745038: A Single Arm Pilot Trial of a Social Network Intervention
Official title: A Single Arm Pilot Trial of a Social Network Intervention (SONATA) for Older Patients With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: geriatric oncology
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 220
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.

Detailed description: The objective of this study is to conduct a single arm pilot study to assess the feasibility and acceptability of the SONATA intervention among older patients with advanced cancer. We hypothesize that the SONATA intervention will be feasible \[≥70% enrolled patient subjects (excluding those who die during the study) will complete at least 3 of the SONATA sessions\] and acceptable \[average patient subject general acceptability score ≥4 (range one to five) using the Theoretical Framework of Acceptability questionnaire.\]

Eligibility criteria: Patient

Inclusion Criteria:

1. Age ≥60 years
2. A diagnosis of advanced or likely incurable cancer, as determined by the primary oncologist
3. Able to speak English
4. Able to provide informed consent

Exclusion Criteria:

1) Any psychiatric or cognitive impairments interfering with participation as determined by the primary oncology team

Network Members:

Inclusion Criteria:

1. Age ≥18 years
2. Identified as a network member by patient subjects (up to 10 network members)
3. Able to speak English
4. Able to provide informed consent.

Exclusion Criteria:

None

Primary outcomes:
measure: Feasibility - SONATA Intervention
timeFrame: 20 Weeks
measure: Acceptability- SONATA Intervention
timeFrame: 20 Weeks
Secondary outcomes:
measure: Estimate - Social Support
timeFrame: 20 Weeks
measure: Estimate - Trust in Healthcare Professionals
timeFrame: 20 Weeks
measure: Estimate - Adherence to oral anticancer treatments
timeFrame: 20 Weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Kah Poh Loh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06487338: Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain
Official title: Effect of Low-level Laser Therapy Versus Shock Wave Therapy on Pain and Function in Patients With Chronic Non-specific Low Back Pain: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Keywords: Low-level laser therapy
Shock wave therapy
Pain
Function
Chronic Non-Specific Low Back Pain
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A significant global source of disability is low back pain. Maladaptive variations in the level of activity in the lumbar musculature are one thing that could possibly contribute to persistent pain.


Eligibility criteria: Inclusion Criteria:

1. All patients will suffer from mechanical low back pain
2. Age will range from 20 to 40 years
3. All patients will have BMI range from 20-24

Exclusion Criteria:

1. History of radicular pain
2. Lumbar disc prolapse.
3. Visual problems
4. History of previous lumbar surgery
5. BMI more than 24

Primary outcomes:
measure: Oswestry low back disability questionnaire
timeFrame: 30 minutes
measure: Back pain functional scale
timeFrame: 20 minutes
measure: Visual analogue scale
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References: