louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03034980: Influence of Training Intensity in Coronary Artery Disease
Official title: Influence of Training Intensity on Exercise Capacity and Risk Profile in Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2017-01-27
Enrollment: 343
Sex: ALL
Minimum age (years): 25
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with proven coronary artery disease, who underwent the full cardiac revalidation program at Jessa Hospital from 10-1-2013 till 12-9-2016.

Brief summary: Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Following hospitalisation, the patients are offered to attend a classical rehabilitation program with moderate exercise intensity. Current exercise program for cardiac rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve the exercise capacity and risk profile even more if the exercise program includes more vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG) and takes 12 weeks to complete. Patients with heart failure and valvular disease are excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training load during rehabilitation.

The research goal is to investigate the influence of training intensity on the exercise capacity and risk profile of CAD patients.


Eligibility criteria: Inclusion Criteria:

* Patients with acute myocardial infarction (AMI), who underwent a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The 12-week program must be completed.

Exclusion Criteria:

* Patients with heart failure (HFpEF and HFrEF with ejection fraction ≤40%) and valvular heart disease.

Primary outcomes:
measure: exercise capacity
timeFrame: up to week 12
Secondary outcomes:
measure: cardiovascular risk profile
timeFrame: up to week 12
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
Study officials:
affiliation: Catholic University Leuven, Belgium
name: Kaatje Goetschalckx, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05265780: Effect of Kinesiotaping on Elbow Joint Proprioception
Official title: Effect of Kinesiotaping on Elbow Joint Proprioception
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: assessing the effects of kinesiotape application on elbow joint proprioception

Detailed description: assessing the effects of kinesiotape application on elbow joint proprioception by evaluating joint position sense

Eligibility criteria: Inclusion Criteria:

* 18-85 years

Exclusion Criteria:

* any elbow disorders
* any neurological disorders

Primary outcomes:
measure: proprioception by evaluating the joint position sense
timeFrame: 35 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Balçova
country: Turkey
facility: School of Physical Therapy and Rehabilitation
state: İzmir
Study officials:
affiliation: Dokuz Eylul University
name: kevser sevik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02491580: Post-transplant Cancer Incidence and Survival in Patients With or Without Pre-transplant Cancer
Official title: Post-transplant Cancer Incidence and Survival in Patients With or Without Pre-transplant Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neoplasms
Kidney Failure
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 2370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplanted patients in Uppsala or Europe with or without a pre-transplant cancer.

Brief summary: Patients with previous malignancies have increasingly been accepted for renal transplantation. However, post-transplant malignancy risk and survival rates of these patients are unknown. Our aim was to assess if previous malignancies pose an unnecessarily high risk of post-transplant malignant tumours and if the organs as a resource are too limited for investment in this patient group.


Eligibility criteria: Inclusion Criteria:

* Kidney transplanted patients from January 1982 through December 2013 with or without a pre transplant cancer.

Exclusion Criteria:

* Simultaneous kidney+pancreas transplantation.
* Islet cell transplanted patients
* Undiagnosed malignancies at the time of transplantation
* Death within a week after transplantation
* First transplantation at another hospital

Primary outcomes:
measure: Incidence of post-transplant cancer
timeFrame: Up to 33 years starting in January 1982.
Secondary outcomes:
measure: Patient survival
timeFrame: Up to 33 years starting in January 1982.
measure: Cancer-induced mortality
timeFrame: Up to 33 years starting in January 1982.
Other outcomes:
measure: Graft survival
timeFrame: Up to 33 years starting in January 1982.
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University, Department of Surgical Sciences, Section of Transplantation Surgery
Study officials:
affiliation: Uppsala University
name: Vivan Hellström, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hellstrom V, Lorant T, Dohler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225.
Clinical trial NCT02459080: Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase 3, 12-week, Randomized, Double-blind Placebo-controlled Parallel Group Study of Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease, COPD
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2015-06-01
Enrollment: 619
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the effectiveness and safety of TD 4208, an investigational drug being developed to treat people with moderate to very severe COPD, compared to placebo, a treatment without activity.


Eligibility criteria: Inclusion Criteria:

* Subject is a male or female subject 40 years of age or older

Exclusion Criteria:

* Females who are pregnant, lactating, breast-feeding or planning to become pregnant during the study

Primary outcomes:
measure: Change From Baseline in Trough FEV1 on Day 85
timeFrame: Day 85
Secondary outcomes:
measure: Summary of Trough FEV1 Overall Treatment Effect From Day 15 to Day 85
timeFrame: Days 15 to 85
measure: Summary of Change From Baseline to Peak FEV1 After First Dose
timeFrame: 0-2 hours after First Dose Day 1
measure: Summary of Rescue Medication Use: Puffs Per Day
timeFrame: 1-3 Months
measure: Percentage of Albuterol Rescue-free 24-hour Periods
timeFrame: 1-3 Months
measure: St. George's Respiratory Questionnaire (SGRQ) Proportion of Responders on Day 85
timeFrame: Baseline to Day 85
Other outcomes:
Locations:
city: Portland
country: United States
facility: Allergy Associates Research Center (AARC)
state: Oregon
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.
citation: Donohue JF, Kerwin E, Barnes CN, Moran EJ, Haumann B, Crater GD. Efficacy of revefenacin, a long-acting muscarinic antagonist for nebulized therapy, in patients with markers of more severe COPD: a post hoc subgroup analysis. BMC Pulm Med. 2020 May 11;20(1):134. doi: 10.1186/s12890-020-1156-4.
Clinical trial NCT05079880: Effect of Caffeine on Time to Anesthetic Emergence After Laparoscopic Cholecystectomy : Randomized-controlled Trial
Official title: Effect of Caffeine on Time to Anesthetic Emergence After Laparoscopic Cholecystectomy : Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Laparoscopic Cholecystectomy
Keywords: Caffeine
Anesthesia emergence
Cholecystectomy
Sevoflurane
Lead sponsor: Tunis University
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A faster emergence from general anesthesia has a double medico-economic impact by reducing the risks of complications and optimizing the performance of surgical units. No drug has been retained for its ability to actively accelerate anesthetic emergence by antagonizing hypnotics. Thus, the aim of this study was to examine the effect of caffeine on the time to emerge from sevoflurane anesthesia for laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* American society of Anesthesiologists (ASA) I and II patients, aged older than 18 years old and scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* Patient with an allergy to caffeine citrate and analgesics used during postoperative period, those with severe renal or hepatic failure, those who refused to participate in addition to patient with heart rhythm disorder, seizure disorder, hypertension, alcoholic or psychiatric illness

Primary outcomes:
measure: anesthetic recovery time
timeFrame: Postoperative
Secondary outcomes:
measure: plasma caffeine levels at H1 and H24
timeFrame: Hour 1 and Hour 24
measure: postoperative rehabilitation
timeFrame: 24 hours postoperatively
measure: postoperative pain (Visual Analog Scale score 0 "no pain" to 10 "severe pain") and consumption of morphine
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Habib Thameur Hospital
Study officials:
References:
Clinical trial NCT03358680: Temperature and Analgesia Monitoring During Cardial Parmonary Bypass
Official title: Temperature and Analgesia Monitoring During Cardial Parmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: China International Neuroscience Institution
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 39
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: the patients schedule undergoing coronary artery bypass surgery

Brief summary: 1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
2. effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
5. Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

Detailed description: In this study,

1. Investigator will apply IOC2 to reflect the depth of analgesic during hypothermia in CPB period.
2. Furthermore, investigator evaluated the effectiveness of IOC2 monitoring for anesthetic depth versus commonly used vital sign monitoring based on factors such as blood pressure and heart rate.
3. Evaluate the other sedation co-relation measurement, include BIS , IOC2 to reflected the consciousness during the operation.
4. Evaluate the other hemodynamic index, include CO, SVV, CVP, PPV to reflect the circulation function , and the effect to the IOC2 and IOC1.
5. Describe the trend of all the measurement. detect the variation of the index during the temperature change during the CPB.

Eligibility criteria: Inclusion Criteria:

* undergoing coronary artery bypass surgery

Exclusion Criteria:

* change the surgery planning during the operation

Primary outcomes:
measure: IOC2
timeFrame: 1 DAY
Secondary outcomes:
measure: BIS
timeFrame: 1 DAY
measure: IOC1
timeFrame: 1 DAY
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Zhaolong Tian, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02439580: Effect of Annona Muricata Leaves on Colorectal Cancer Patients and Colorectal Cancer Cells
Official title: Effect of Annona Muricata Leaves on Nutritional Status, Quality of Life, Fecal Butyrate, Inflammation, and Colorectal Cancer Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Keywords: Patients
After Surgery
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 30
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: Annona muricata L., include the leaves, is found to contain biologically active Annonaceous acetogenins and plant polyphenols that are important components of human diet and a number of them are considered to have chemopreventive and therapeutic properties against cancer.

To confirm previous findings in in vitro, animal study and traditionally use, a human, ex vivo and in vitro studies were conducted to evaluate the effects of consecutive ingestion of A. muricata leaves extract for eight weeks.

Detailed description: Colorectal cancer patients were randomly assigned to receive either A. muricata leaves extract or placebo. Dietary intakes and anthropometry were assessed with food record every two weeks. Blood parameters, nutritional status, quality of life, fecal butyrate level, and systemic inflammation of patient were assessed at the beginning and the end of study.

Eligibility criteria: Inclusion Criteria:

* Patients with Colorectal Carcinoma
* Have undergone standard therapy
* Satisfactory haematological or biochemical functions
* Karnofsky performance status of ≥ 60%
* Willing not to take probiotic supplement during study period

Exclusion Criteria:

* Uncontrolled hypertension
* Serious heart, kidney, liver endocrine or neurologic/psychiatric diseases
* Physical and mental disability that renders them unable to verbally communicate
* History of recent cancers
* Pregnant, lactating, or not using adequate contraception
* Patient on other investigational drug

Primary outcomes:
measure: Nutritional Status
timeFrame: eight weeks
Secondary outcomes:
measure: Cytotoxicity
timeFrame: two days
Other outcomes:
Locations:
Study officials:
affiliation: Indonesia University
name: Lili Indrawati, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02984280: Specific Respiratory Infections as Triggers of Acute Medical Events
Official title: Specific Respiratory Infections as Triggers of Acute Medical Events: Time Series Analysis Using LabBase and Hospital Episode Statistics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Respiratory Syncytial Virus Infections
Parainfluenza
Rhinovirus
Adenovirus
Human Metapneumovirus Pneumonia
Cardiovascular Diseases
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Public Health England
First posted: 2016-12-06
Enrollment: 787000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult population of England who have received NHS care during the study period.

Brief summary: This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics.

Detailed description: We will conduct a time series study correlating anonymised population level data on all samples from NHS laboratories testing positive for six common respiratory viruses with admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models controlling for factors such as seasonal and long-term trends, environmental temperature and humidity.

This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.

Eligibility criteria: Inclusion Criteria:

* Any individual with a record of an eligible outcome (ICD-10 coded hospitalisation for myocardial infarction or stroke) within the study period aged 45+ years
* Any individual with a record of an eligible exposure (laboratory-confirmed respiratory virus) within the study period at any age

Exclusion Criteria:

* Outcome events occurring in people aged \<45 years

Primary outcomes:
measure: Acute myocardial infarction
timeFrame: 01/01/2004 to 31/12/2014
measure: Stroke
timeFrame: 01/01/2004 to 31/12/2014
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London (UCL)
Study officials:
affiliation: UCL
name: Charlotte MJ Warren-Gash, MRCP PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blackburn R, Zhao H, Pebody R, Hayward A, Warren-Gash C. Laboratory-Confirmed Respiratory Infections as Predictors of Hospital Admission for Myocardial Infarction and Stroke: Time-Series Analysis of English Data for 2004-2015. Clin Infect Dis. 2018 Jun 18;67(1):8-17. doi: 10.1093/cid/cix1144.
Clinical trial NCT04065880: Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
Official title: Neoveil® Versus TachoSil® for the Treatment of Pulmonary Air Leaks Following Lung Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prolonged Air Leak
Postoperative Air Leak
Keywords: lung resection
TachoSil®
Neoveil®
air leak closure
drainage time
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Postoperative prolonged air leak (PAL), referring to the passage of air from the lung parenchyma into the pleural space, is one of the most frequent postoperative complications after lung resection. To control air leak, there are two different products certified since years: TachoSil® and Neoveil®. This study is to investigate the difference of TachoSil® and Neoveil® in patients with PAL.


Eligibility criteria: Inclusion Criteria:

* Patients with a pulmonary air leak following open lung surgery, regardless of whether an anatomical or atypical resection was performed
* Patients who are able to decide for themselves whether to participate in the study or not ( for example due to language problems, mental disorders, dementia of the participant)
* Patients who are not family member or employee of the investigator

Exclusion Criteria:

* Inability to follow the procedures of the study, for example, due to language problems, mental disorders, dementia of the participant
* Enrolment of the investigator, his/her family members, employees and other dependent persons

Primary outcomes:
measure: time required till air leak closure has occurred (hours)
timeFrame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
Secondary outcomes:
measure: Incidence of air leak (binary outcome 0/1), i.e. air loss > 30ml
timeFrame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
measure: Intensity of air leak (continuous outcome, ml)
timeFrame: end of the operation (0 hours) until removal of the chest tubes or re-operation in case of prolonged air leak (first postoperative day)
measure: Incidence of prolonged air leak (>10 days) (binary outcome 0/1)
timeFrame: assessed at 10th postoperative day
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Thoracic Surgery, University Hospital Basel
Study officials:
affiliation: Department of Thoracic Surgery, University Hospital Basel
name: Didier Lardinois, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bachmann H, Dackam SVC, Hojski A, Jankovic J, Vogt DR, Wiese MN, Lardinois D. Neoveil versus TachoSil in the treatment of pulmonary air leak following open lung surgery: a prospective randomized trial. Eur J Cardiothorac Surg. 2022 Dec 2;63(1):ezad003. doi: 10.1093/ejcts/ezad003.