louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04416295: Selfcare MAnagement InteRvenTion in COPD (SMART COPD)
Official title: Evaluation of a Digital Support and Communication Platform for COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Copd
Assessment, Self
Hospitalization
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate whether a digital support and communication platform for COPD patients after 6 months provides:

1. Decreased breathlessness on the basis of modified medical research council dyspnea scale \[mMRC\]
2. Improved health status and symptom relief based on COPD assessment scale \[CAT\]
3. Improved quality of life based on EQ-5D
4. Reduction in the number of incidents, hospital nights, the number of hospitalizations, outpatient contacts or the number of deaths related to COPD
5. A change in the classification of COPD severity based on GOLD A-D


Eligibility criteria: Inclusion Criteria:

The patient is included in the study in connection with visits to COPD.

* Diagnosed COPD J44 (newly discovered or existing)
* Have completed the consent form
* Is judged to be able to handle the intervention himself or with the help of staff or relatives

Exclusion Criteria:

Patient who declines to participate in the trial.

* Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
* Life expectancy \<8 months
* In other ways, treating physicians are deemed to be inappropriate to participate in the study, e.g. due to participation in another study.

Primary outcomes:
measure: Severity of dyspnea on the basis of modified medical research council dyspnea scale [mMRC]
timeFrame: 6 months
measure: Change in health status and symptom relief based on COPD assessment scale [CAT]
timeFrame: 6 months
measure: Change in quality of life
timeFrame: 6 months
measure: A change in the classification of COPD severity based on GOLD A-D
timeFrame: 6 months
measure: Change in patient reported symptoms
timeFrame: 6 months
measure: Number of participants with COPD related events and deaths during intervention and up to 12 months after inclusion
timeFrame: 12 months
measure: Number of participants with new hospitalization up 12 months after inclusion
timeFrame: 12 months
measure: Number of hospital days during intervention and up 12 months after inclusion
timeFrame: 12 months
measure: Number of health care visits during intervention and up to 12 months after inclusion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
state: Skåne
Study officials:
References:
citation: Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
Clinical trial NCT05071495: TeleDiet Study: The Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
Official title: TeleDiet Study: A Randomized Controlled Study Investigating the Impact of Dietary Education and Counseling With a Smartphone Application on Secondary Prevention of Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Secondary Prevention
Diet Therapy
Lead sponsor: Jessa Hospital
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 60
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: Digital cardiology is gaining power in the field of preventive cardiology recently, and several trials have already shown good results of dietary therapy with digital cardiology. However, there has been no reports that showed effect of dietary counseling through digital cardiology for secondary prevention of coronary artery disease.

TeleDiet study investigates the impact of dietary therapy with a smartphone application on the content of meals and metabolic parameters for patients with coronary artery disease.


Eligibility criteria: Inclusion Criteria:

1. Owning a smartphone and able to use it
2. Written informed consent obtained
3. Starting cardiac rehabilitation
4. Coronary artery disease

Exclusion Criteria:

1. Special diet due to other reasons (eg. renal diet, pancreatic insufficiency diet)
2. Age \<18 years old
3. Pregnancy

Primary outcomes:
measure: MedDiet score (the Mediterranean diet score)
timeFrame: Up to 3 months
Secondary outcomes:
measure: Blood lipid tests (LDL-cholesterol [LDL-C], HDL-cholesterol [HDL-C], and triglyceride [TG])
timeFrame: Up to 3 months
measure: Blood glycated hemoglobin (HbA1c) test
timeFrame: Up to 3 months
measure: Blood creatinine (Cr) test
timeFrame: Up to 3 months
measure: Parameters in the ergospirometer test (maximal oxygen consumption [VO2 max])
timeFrame: Up to 3 months
measure: Parameters in the ergospirometer test (anaerobic threshold [AT])
timeFrame: Up to 3 months
measure: Values of self-efficacy (questionnaire of General Self-Efficacy Scale [GSE])
timeFrame: Up to 3 months
measure: Values of medication adherence (questionnaire of Identification of Medication Adherence Barriers [IMAB])
timeFrame: Up to 3 months
measure: Values of quality of life (Health-related Quality of Life questionnaire [HeartQoL])
timeFrame: Up to 3 months
measure: Body weight (BW)
timeFrame: Up to 3 months
measure: Body mass index (BMI)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
affiliation: Jessa Ziekenhuis vzw
name: Paul Dendale
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06006195: Investigating the Correlations Between Dysphagia Symptoms and Swallowing Muscle Groups by HRPM-I
Official title: Investigating the Correlation Between Dysphagia Symptoms and Swallowing Muscle Groups by High-Resolution Pharyngeal Manometry With Impedance, Along With the Associated Nutritional Assessment
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Swallowing Contraction Strength
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients age from 20 to 80 years old without major organ dysfunction

Brief summary: Investigating the correlation between the dysphagia symptoms and swallowing muscle groups by high resolution pharyngeal manometry with impedance

Detailed description: Backgrounds: Some patients would experience dysphagia symptoms before the elective surgery. These patients usually do not have a history of head and neck surgery or cerebrovascular diseases. They are common causes of dysphagia. The anesthetics and airway manipulation can exacerbate dysphagia. However, research is limited on the specific weak muscle groups in patients with dysphagia symptoms, as well as on the existence of associated malnutrition.

Aims: The Eating Assessment Tool (EAT-10) questionnaire will be used to assess dysphagia symptoms. A score of ≥4 on the EAT-10 indicates the presence of dysphagia symptoms, while a score of \<4 indicates the absence. This study aims to (1) investigate which specific muscle groups are particularly weak in patients with dysphagia symptoms (EAT-10≥4); (2) to examine whether patients with dysphagia symptoms (EAT-10≥4) have poorer nutritional status than patients without dysphagia symptoms (EAT-10\<4).

Methods: This is a cross-sectional study. The investigators will recruit patients undergoing elective orthopedic surgery on the lower extremities, with the age range of 18 to 90 years. On the day of admission, patients will be examined by the EAT-10 questionnaire for dysphagia symptoms. High-resolution pharyngeal manometry with impedance will be conducted to measure the functional of swallowing muscles. Additionally, patients will be given the Mini Nutritional Assessment (MNA) questionnaire (a total score of 30 points). The higher scores indicate the better nutritional status. The albumin level will also be collected. The bioelectrical impedance analysis will be used to measure the patients' body composition, specifically skeletal muscle mass.

Eligibility criteria: Inclusion Criteria:

* age from 20 to 80 years

Exclusion Criteria:

* bleeding tendency
* pregnancy
* heart failure
* chronic kidney disease

Primary outcomes:
measure: UES peak pressure, mmHg
timeFrame: 10 to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05752695: Operation Korsband
Official title: Risk Factors for Cruciate Ligament Injuries
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: Kalmar County Hospital
First posted: 2023-03-03
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes with ACL defined ACL injury.

Brief summary: This study aims to investigate if a detailed and comprehensive survey can identify, explain and prevent the risk factors for ACL injury.

A a new questionnaire has been developed with questions to young athletes who have suffered an anterior cruciate ligament injury. The questionnaire is more detailed and provide more information about how the anterior cruciate ligament injury occurred compared with the questionnaires currently available in the literature. This careful documentation will provide new knowledge and might be used to identify, explain and prevent risk factors that cause young athletes to suffer an anterior cruciate ligament injury.

Detailed description: Participants will be prospectively recruited at their first physiotherapist clinical session. On this occasion, participants will be asked to fill in a questionnaire regarding injury situation, game or training, sex, age, sport affiliation, level of sport, other aspects of sport such as participation in several teams and junior versus senior games/training. In addition, questions regarding previous injury will also be documented.

Eligibility criteria: Inclusion Criteria:

* Athlete
* Defined ACL injury

Exclusion Criteria:

* Non athletes
* Younger than 12 years

Primary outcomes:
measure: Total work load
timeFrame: Day 1
Secondary outcomes:
measure: Number of teams
timeFrame: Day 1
measure: Injury situation 1
timeFrame: Day 1
measure: Injury situation 2
timeFrame: Day 1
measure: Injury situation 3
timeFrame: Day 1
measure: Physical well-being
timeFrame: Day 1
measure: Mental wellbeing
timeFrame: Day 1
measure: Previous injury
timeFrame: Day 1
Other outcomes:
Locations:
city: Kalmar
country: Sweden
facility: Sofia Ryman Augustsson
Study officials:
References:
Clinical trial NCT05699395: Quick Recognition of Aortic Dissection
Official title: Identification of Aortic Dissection Based on Pulse Oxygen and Ultrasound Doppler Waveforms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk chest pain patients

Brief summary: This is an observational study that establishes a cohort of patients with high risk chest pain who have been identified by CTA for aortic dissection. We then used this cohort to validate the accuracy of identifying aortic dissection based on extremity oximetry and Doppler waveforms.


Eligibility criteria: Inclusion Criteria:

* High risk chest pain with CTA

Exclusion Criteria:

* shock
* coma
* severe peripheral vascular diseases

Primary outcomes:
measure: Diagnosis of aortic dissection
timeFrame: First 24-hours during emergency dapartment stay
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
Study officials:
References:
Clinical trial NCT05417295: Bronchial Injury Caused by Bronchial Cuff
Official title: Position Related Bronchial Injury Caused by Bronchial Cuff of Double Lumen Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchial Hemorrhage
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Double lumen endotracheal tubes (DLT) are wildly used to maintain independent lung ventilation during thoracic surgery. Our aim is to assess whether the DLT bronchial cuff inflated or not is associated with tube displacement and bronchial mucosal injury while changing position.

Detailed description: Experiment group: Before changing from supine position to lateral position, inflate air into the bronchial cuff of double lumen endotracheal tube (DLT) and adjust cuff pressure to 25-30 mmHg.

Control group: Do not inflate air into the bronchial cuff before changing position.

Main result: Degree of left bronchial mucosal injury. Secondary result: Displacement of double lumen endotracheal tube after changing position.

All patients receive general anesthesia and are intubated with left DLT in the supine position. The fiberoptic bronchoscope is used to check the position via tracheal lumen of DLT. The bronchial lumen is placed at the left bronchus and the edge of bronchial cuff is visible by fiberscope.

Before changing position, the bronchial cuff of experiment group is inflated with air and adjusted cuff pressure to 25-30 mmHg. Both groups of patient's neck are fixed by neck collar in order to prevent displacement of DLT by neck rotation. After changing into lateral position, the assistant inflates 2 ml of into the bronchial cuff of control group and adjust cuff pressure to 25-30 mmHg. The investigator, blinded to the tube assignments, uses the fiberoptic bronchoscope to check position of the tube again via tracheal lumen of DLT and record the distance of displacement.

At the end of the surgery, both lumens of DLT are sucked and bronchial cuffs are deflated. After pulling out 3 cm of the DLT, the patient is changed into supine position and the fiberoptic bronchoscope is used to check the degree of bronchial injury.

Eligibility criteria: Inclusion Criteria:

* Patients receive elective thoracoscopic wedge resection in the lateral position and are intubated with left side double lumen endotracheal tube.

Exclusion Criteria:

* ASA status \> III, coagulopathy, known airway damage, difficult intubation, tracheostomy, double lumen endotracheal tube is displaced during operation which interferes one lung ventilation and needs to be adjusted.

Primary outcomes:
measure: Left bronchial mucosal injury
timeFrame: Before extubation
Secondary outcomes:
measure: Displacement of double lumen endotracheal tube
timeFrame: After changing into lateral position
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01021995: Echinacea Safety Study
Official title: Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections
Keywords: Safety of Echinacea in comparison to placebo
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 757
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during October and November 2009 and will be treated with either Echinacea or placebo over a period of 4 months.

Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at least a possible causal relation to the treatment) will be recorded.

Common cold related symptoms will be recorded in a daily diary.


Eligibility criteria: Inclusion Criteria:

* On average more than 2 cold episodes per year
* Age above 18 years
* Good physical condition
* Signed informed consent

Exclusion Criteria:

* Women without appropriate and effective contraception
* Participation in a clinical trial 30 days prior to this trial
* Pregnant or breast feeding women
* Subjects with pre-existing cold symptoms for more than 24h at inclusion
* Concurrent participation in another clinical trial
* Intake of antimicrobial and/or antiviral medications at inclusion
* Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 gr and / or 10 cigarettes per day)
* Psychiatric disorders which may influence the results of the trial,
* epilepsy, suicide attempts
* Planned surgical intervention during the trial.
* Serious chronic diseases which influence the absorption, metabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukaemia,
* collagen disorders and multiple sclerosis
* Known AIDS, HIV-infections and autoimmune diseases
* Known diabetes mellitus (type 1)
* Corticosteroid-treated asthma
* Atopic and allergic subjects (under medicinal treatment)
* Known allergy to plants of the composite family (Asteraceae)

Primary outcomes:
measure: Occurrence of Adverse Drug Reactions
timeFrame: 4 months
Secondary outcomes:
measure: efficacy
timeFrame: 4 months
Other outcomes:
Locations:
city: Cardiff
country: United Kingdom
facility: Cardiff School of Biosciences
state: Wales
Study officials:
References:
Clinical trial NCT00408395: Safety and Immunogenicity of 2 Commercially Available Influenza Vaccines in Children
Official title: A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a Commercially Available Influenza Vaccine Versus Two 0.25 mL Intramuscular Doses of a Commercially Available Influenza Vaccine in Healthy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: influenza
children
vaccine
influenza disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-06
Enrollment: 281
Sex: ALL
Minimum age (years): 6
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a study of the safety and immunogenicity of three commercially available influenza vaccines in children.

Detailed description: A Phase II, Observer-Blind, Randomized, Parallel Groups, Multicenter, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine versus Two 0.25 mL Intramuscular Doses of a commercially available influenza vaccine in Healthy Children

Eligibility criteria: Inclusion Criteria:

* 6 months to \< 36 months of age

Exclusion Criteria:

* Any severe acute respiratory disease and infections requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
* Other serious diseases such as: cancer, autoimmune disease (including rheumatoid arthritis), diabetes mellitus, chronic pulmonary disease, acute or progressive hepatic or renal disease, or surgery planned during the study period.
* Known or suspected impairment/alteration of immune function
* History of hypersensitivity to any component of the study vaccine, egg products or other vaccine component, or impairment/alteration of immune function

Primary outcomes:
measure: To evaluate the immunogenicity of the 2 vaccines in terms of post-immunization geometric mean titers (GMTs), as measured by the hemagglutination inhibition (HI) test
Secondary outcomes:
measure: To evaluate the immunogenicity of the 2 vaccines in terms of seroprotection, and seroconversion or significant increase, as measured by HI test
measure: To evaluate the safety and tolerability of the 2 vaccines administered 4 weeks apart
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: University of Tampere Medical School
Study officials:
affiliation: Novartis
name: Novartis Vaccines (formerly Chiron Vaccines)
role: STUDY_CHAIR
References:
citation: Vesikari T, Pellegrini M, Karvonen A, Groth N, Borkowski A, O'Hagan DT, Podda A. Enhanced immunogenicity of seasonal influenza vaccines in young children using MF59 adjuvant. Pediatr Infect Dis J. 2009 Jul;28(7):563-71. doi: 10.1097/INF.0b013e31819d6394.