louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04025086: Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position
Official title: Perioperative Goal Directed Therapy (PGDT) in Spinal Surgery in the Prone Position: Optimization of Fluid Therapy, Haemodynamic Impact and on Post-operative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Hypotension
Pulmonary Complication
Cardiovascular Complication
Keywords: Spinal Surgery
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 44 Patients undergoing spinal surgery in prone position at "Gaspare Rodolico Presidium" of Policlinico-Vittorio Emanuele University Hospital of Catania, in which a specific protocol, that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke Volume Variation (SVV) by using a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) o a non-invasive monitoring system with Clearsight® sensor (Edwards), is used.

Brief summary: This study aims at evaluating if a specific protocol, that can be framed in the innovative concept of Perioperative Goal Directed Therapy (PGDT), based on the evaluation of the Stroke Volume Variation (SVV) - a parameter deriving from the adoption of a minimally invasive advanced hemodynamic monitoring technology with a special sensor called FloTrac® (Edwards) or of a non-invasive monitoring system with the Clearsight® sensor (Edwards) - is able to guarantee a greater precision in the intraoperative management of patients undergoing spinal surgery in prone position.


Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years
* American Society of Anesthesiologists(ASA) Classification I-II-III
* Minor and major spinal surgery
* Prone position
* Sinus rhythm
* Absence of atrial fibrillation. or severe arrhythmia
* Informed consent

Exclusion Criteria:

* Absence of informed consent
* Age less than 18 or older than 80 years
* Cardiac rhythm abnormalities: atrial fibrillation and / or severe arrhythmia

Primary outcomes:
measure: Frequency rate of early post-operative complications
timeFrame: 7 days
Secondary outcomes:
measure: Comparison between the two commonly adopted anesthetic techniques (totally intravenous anesthesia (TIVA / TCI) or balanced anesthesia) in terms of intraoperative management of the patient and post-operative complication
timeFrame: 7 days
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Gaspare Rodolico Presidium - University Hospital Policlinico-Vittorio Emanuele
state: Sicilia
Study officials:
References:
Clinical trial NCT06597786: A Study of Exercise Therapy in People With Solid Tumor Cancer
Official title: Neoadjuvant Exercise Therapy in Solid Tumors: A Phase 1b Dose Expansion Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Solid Tumor Cancer
Keywords: Exercise Therapy
24-232
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-center, open-label, phase 1b dose-expansion trial of neoadjuvant (preoperative) exercise therapy in patients with prespecified solid tumors.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out whether exercise therapy is an effective and safe treatment that causes few or mild side effects when done before standard surgery for solid tumor cancer. The researchers will also study whether the program is feasible (practical) by tracking how well participants follow the program.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed (on preoperative biopsy), resectable, treatment naïve cancer of one of the following types: head and neck, lung, renal, liver, colorectal, gastric, ovarian, melanoma, pancreas, or breast cancer.
* Age ≥18 years.
* An interval of ≥3 weeks until planned surgical resection; surgery will not be delayed to accommodate the minimum length of exercise therapy intervention in any circumstance.
* Measurable disease based on standard of care radiology scans or confirmation by the surgeon.
* Body weight ≤ 385 lbs (≤ 174 kg)
* Non-exercisers, defined as ≤60 minutes of moderate or vigorous exercise/week based on self-report using a validated survey.
* Cleared for moderate-intensity exercise therapy using the Physical Activity Readiness Questionnaire (PAR-Q)+ with screening clearance provided at the discretion of the PI/exercise physiologist.
* Willingness to comply with all study-related procedures

Exclusion Criteria:

* Distant metastases.
* Receiving any form of antitumor therapy.
* Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise on study outcomes.
* Any other diagnosis of invasive cancer currently requiring active treatment.
* Any other condition (e.g., pregnancy) or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.

Primary outcomes:
measure: change in Ki67 values
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Lee Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01154686: Working Memory Training in College Students With Attention-Deficit Hyperactivity Disorder/Learning Disabilities
Official title: Working Memory Training in College Students With ADHD/LD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Disorder
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of the current study is to determine whether computerized Working Memory (WM) training will enhance WM capacity in college students with Attention Deficit Hyperactivity Disorder (ADHD)/Learning Disabilities (LD). There are also three additional objectives. The first is to determine whether improvements in WM will generalize to secondary outcome tasks, such as inhibitory control and planning. The second objective is to examine whether WM training will also ameliorate ADHD symptoms of inattention and hyperactivity. The last objective is to investigate whether improvements will be maintained at a two month follow-up period.

It is expected that the computerized WM training program will enhance WM capacity in college students with ADHD. In addition, it is believed that these increases in WM capacity will also lead to improvements in other executive functions. It is also hypothesized that WM training will lead to a reduction in ADHD symptomology. Lastly, these improvements should be maintained at three month follow-up.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ADHD/Learning Disability
* registered as a university student (full or part time)
* registered at accessibilities services
* taking at least one course

Exclusion Criteria:

* On a leave

Primary outcomes:
measure: Paced Auditory Serial Addition Test (auditory verbal working memory measure)
timeFrame: within 120 days
Secondary outcomes:
measure: Cognitive Failures Questionnaire
timeFrame: within 120 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Rachel Gropper, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04525586: lncRNA-based Nomogram to Assist Childhood Asthma Diagnosis
Official title: LncRNA and Predictive Model to Improve the Early Diagnosis of Childhood Asthma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Childhood Asthma
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with recurrent wheezing who apply to Department of Respiratory Medicine, Children's Hospital of Fudan University.

Brief summary: Asthma is the most common chronic disease in children, however, underdiagnosis of childhood asthma is an important issue in asthma management. The lack of reliable and objective diagnostic indicators requires the development of rapid and accurate strategies for the early diagnosis of childhood asthma. Recent studies have found a correlation between long-chain non-coding RNA (lncRNA) expression and childhood asthma, suggesting that lncRNA may be a potential biomarker for asthma diagnosis.

Detailed description: The investigators envision exploring the early diagnosis of asthma by combining lncRNA with electronic medical records. In this project, the investigators will combine high-throughput sequencing, asthma case database, electronic medical record and informatics to investigate the feasibility of combining lncRNA with electronic medical record for asthma diagnostic model. The expected results will establish the foundation for the diagnosis and treatment of childhood asthma and open up new ideas.

Eligibility criteria: Inclusion Criteria:

children with recurrent wheezing

Exclusion Criteria:

1. diagnosis of other chronic respiratory disease (e.g. cystic fibrosis, bronchopulmonary dysplasia, etc)
2. immunodeficiency- acquired or congenital
3. neuromuscular disease
4. congenital heart disease

Primary outcomes:
measure: rate of early diagnosis of childhood asthma
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Fudan University
name: Liling Qian, PhD.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02890186: Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index
Official title: Dual-loop Target Controlled Infusion for Coadministration of Propofol and Remifentanil Guided by Narcotrend Index in Anterior Cervical Decompression and Fusion With Internal Fixation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Anesthesia
Keywords: narcotrend
propofol
remifentanil
closed-loop of target controlled infusion
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 60
Sex: ALL
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the application of closed target-controlled infusion(TCI) of propofol and remifentanil guided by Narcotrend index in the anterior cervical decompression and fusion with internal fixation surgery.

Detailed description: Sixty patients scheduled for anterior cervical decompression and fusion with internal fixation surgery under general anesthesia were randomly divided into two groups:closed-loop (group A,n=30) and open-loop group(group B,n=30).The procedure during induction of anesthesia was same in two groups.In group A,if Narcotrend index(NI) fall down to 46 and keep more than 30 seconds,propofol and remifentanil were intravenously infused as feedback automatically to achieve the target NI of 26-46.However,the NI in group B was controlled manually.

Eligibility criteria: Inclusion Criteria:

1. ASA Ⅰ \~ Ⅱ women undergoing Laparoscopic surgery.
2. Written informed consent from the patient or the relatives of the participating patient.
3. BMI:18.0～25 kg/m2

Exclusion Criteria:

1. Mental illness can not match
2. epidural anesthesia contraindicated
3. People who have Slow-type arrhythmias
4. Chronic renal failure
5. Alcohol or drug abuse
6. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Primary outcomes:
measure: the total dose of propofol and remifentanil
timeFrame: within three hours from the beginning to the end of the propofol and remifentanil
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
Clinical trial NCT05730686: FibroLamellar Carcinoma: an International Registry Study
Official title: FibroLamellar Carcinoma: an International Registry Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibrolamellar Cancer of the Liver
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective patients will be recruited from clinic

Brief summary: Fibrolamellar Hepatocellular Carcinoma (FLC) is a rare (0.05 per 100,000) subtype of primary liver cancer which predominantly affects younger patients, median age of diagnosis 22-23 years. In patients with advanced stage disease the prognosis is poor, and even with aggressive surgery the 5 year survival is less than 50%.

Due to the very low incidence of FLC clinical trials are limited, and as these patients are excluded from most clinical trials there is a lack of consensus on the optimal systemic therapy to employ in this population group.

There are a number of chemotherapy compounds that have been investigated although these are single-institutional case series and/or registry-based studies. The majority of published registry studies are based in the United States hence it is important to describe the patterns of treatment in Europe which has different regulatory approvals for access to therapeutics. Our aim is to run a European multisite registry study detailing the clinical course of \>100 patients with FLC that have received systemic therapy.


Eligibility criteria: Inclusion Criteria:

* Histologic confirmed diagnosis of FLC
* Written informed consent will be required for the prospective cohort
* Adults of \>18 years of age

Exclusion Criteria:

* Any non- histologic confirmed diagnosis of FLC
* Participants with insufficient clinical/ follow up data

Primary outcomes:
measure: To describe the natural history and clinical outcomes of patients with Fibrolamellar carcinoma of the liver
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06211686: The Effectiveness of a Health Promotion Program for Older People With Post-Covid-19 Sarcopenia
Official title: The Effectiveness of a Health Promotion Program for Older People With Post-Covid-19 Sarcopenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post COVID-19 Condition
Keywords: Sarcopenia
Older people
Health Promotion Program
Post COVID-19
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: National Health Security Office, Thailand
First posted: 2024-01-18
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Phase I: Descriptive survey research Phase II: Quasi-experimental research
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to investigate the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok and to test the effectiveness of health promotion program for older people with post-COVID-19 Sarcopenia. The main questions it aim to answer are: • How many is the prevalence of sarcopenia in older people with post-COVID-19 living in Ratchatewi district, Bangkok? • Can the health promotion program improve muscle mass and muscle strength in older people with post-COVID-19 Sarcopenia ? Participants will be asked eating protein supplement one scoop /day and exercising 2 times/week for 3 months.


Eligibility criteria: Inclusion Criteria:

* Older people with post-COVID-19 sarcopenia aged more than and equal 60 years
* No disabilities
* Able to read, write and communicate Thai langue
* Live in Bangkok
* Moderate post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale
* No soy protein allergy
* Sign inform consent

Exclusion Criteria:

* Severe post-covid-19 state defined by Thai version of the COVID-19 Yorkshire Rehabilitation Scale and complicated health problems
* Disabilities
* Unable to read, write and communicate Thai langue
* Soy protein allergy
* CKD 4 and CKD 5
* Deny or withdraw from project

Primary outcomes:
measure: Muscle mass
timeFrame: 3 months
measure: Muscle strength
timeFrame: 3 motnhs
measure: Physical fitness
timeFrame: 3 months
Secondary outcomes:
measure: Prevalence of sarcopenia
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05553886: S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction
Official title: A Randomized, Double-blind, Positive-drug Parallel Controlled, Multicenter Phase III Trial of the Efficacy and Safety of S086 Tablets in Patients With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Chronic Heart Failure With Reduced Ejection Fraction
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, positive drug parallel control, multicenter
Primary purpose: TREATMENT

Brief summary: A randomized, double-blind, positive-drug parallel controlled, multicenter phase III trial of the efficacy and safety of S086 tablets in patients with chronic heart failure with reduced ejection fraction (HFrEF)


Eligibility criteria: Inclusion Criteria:

1. Patients with chronic heart failure (NYHA grade ⅱ-ⅳ) with reduced ejection fraction (LVEF≤40%) and elevated BNP were diagnosed 1a.
2. Patients received a stable dose of the underlying treatment for heart failure, defined as no change in dose for at least 4 weeks before screening 1b.
3. Volunteer to participate in the trial and sign an informed consent form 1c.

Exclusion Criteria:

1. Previous continuous administration of sacubitril valsartan sodium 150mg bid or more for more than 3 months 1a.
2. Use of other study drugs or use of any study medical device within 1 day of the visit or within 30 days prior to the visit or within 5 half-lives of the drug, whichever is longer 1b.
3. Known or suspected allergy to S086, sacubitril valsartan sodium, ARB, ACEI, or enkephin inhibitor (NEPI), and known or suspected contraindications to sacubitril valsartan sodium 1c.
4. A previous history of intolerance to the recommended target dose of ACEI or ARB 1d.
5. He had a history of angioedema 1e.
6. Acute coronary syndrome occurred within 6 weeks before visit 1 1f.

Primary outcomes:
measure: Sacubitril valsartan sodium tablets (trade name: Nohintal) were used as a control to study the efficacy of S086 tablets in the treatment of Chronic heart failure with reduced ejection fraction（HFrEF）.
timeFrame: the end of 28th week
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People' S Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02730286: Activity Limitations in Rheumatoid Arthritis
Official title: Factors Associated With Activity Limitations in Individuals With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: human activity
International Classification of Functioning
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: For this cross-sectional study, 81 patients treated between June 2009 and August 2010 in Clinics Hospital, at the Universidade Federal de Minas Gerais (UFMG) in Brazil were recruited by convenience sampling

Brief summary: Objective: To evaluate what factors contribute to activity limitations in subjects with rheumatoid arthritis considering the International Classification of Functioning, Disability and Health model.

Methods: A cross-sectional study on 81 individuals with rheumatoid arthritis (RA) using instruments to measure five constructs of the component activities.

Detailed description: The investigators used the ICF model to analyze factors reported to be associated with functioning and disability in individuals with RA, including dexterity fatigue, stiffness , pinch, handgrip, strength, range of motion (ROM) deficit, deformities , mental health, vitality, and pain .

Eligibility criteria: Inclusion Criteria:

* Age over 18 years,
* Clinical diagnosis rheumatic arthritis
* Mental competence by the Mini-Mental State Examination

Exclusion Criteria:-

* Had undergone upper limb surgery,
* Had an uncorrected visual deficit that could compromise functionality

Primary outcomes:
measure: Model 1- Test d´Evaluation dês Membres Supérieurs de Personnes Agées, - TEMPA rheumatoid arthritis
timeFrame: up to thirty minutes
measure: Model 2- Sequential Occupational Dexterity Assessment (SODA)
timeFrame: up to thirty minutes
measure: Model 3 and 4- SF-36=Short form health survey-36
timeFrame: up to thirty minutes
measure: Model 5 - AIMS=Arthritis impact measurement scale
timeFrame: up to thirty minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Andrade JA, Brandao MB, Pinto MR, Lanna CC. Factors Associated With Activity Limitations in People With Rheumatoid Arthritis. Am J Occup Ther. 2016 Jul-Aug;70(4):7004290030p1-7. doi: 10.5014/ajot.2016.017467.