louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01963923: Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection
Official title: Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Exercise Tolerance and Quality of Life in Patients Awaiting Lung Resection by Video-assisted Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: Pulmonary Rehabilitation
Lung Cancer Resection
Video-assisted thoracic surgery
Exercise tolerance
Quality of life
Lead sponsor: Universidade da Coruña
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
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 establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.


Eligibility criteria: Inclusion Criteria:

* Diagnosis confirmed or suspected of lung cancer (either primary or metastatic)
* Be on the waiting list for lung resection by Video-assisted thoracic surgery
* Present at least one of the next conditions: Forced Expiratory Volume in 1 second (FEV1)\<80% of predicted and/or Body Mass Index \> 30 or/and \>80 years old and/or two or more comorbidities (Arterial Hypertension, Chronic Obstructive Pulmonary Disease, Coronary Disease, Diabetes, Renal Failure and/or cancer.
* No smoking at the time of recruitment
* Signed Informed Consent

Exclusion Criteria:

* Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
* Thoracotomies or pneumonectomies.

Primary outcomes:
measure: Exercise Tolerance
timeFrame: Exercise tolerance 3 weeks after hospital discharge
measure: Exercise Tolerance
timeFrame: Exercise tolerance 3 months after surgery
Secondary outcomes:
measure: Health-Related Quality of Life
timeFrame: Quality of life 3 weeks after surgery
measure: Health-Related Quality of Life
timeFrame: Quality of life post-surgery
measure: Upper Body Strength
timeFrame: 3 weeks post-surgery
measure: Upper Body Strength
timeFrame: 3 months post-surgery
measure: Lower Body Strength
timeFrame: 3 weeks post-surgery
measure: Lower Body Strength
timeFrame: 3 months post-surgery
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
Study officials:
References:
citation: Sebio Garcia R, Yanez-Brage MI, Gimenez Moolhuyzen E, Salorio Riobo M, Lista Paz A, Borro Mate JM. Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial. Clin Rehabil. 2017 Aug;31(8):1057-1067. doi: 10.1177/0269215516684179. Epub 2016 Dec 20.
Clinical trial NCT00314223: Identification of Gene Polymorphism in Patients With Sick Sinus Syndrome in Chinese Population in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sinus Arrhythmia
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2006-04-13
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: Background: Sinus node dysfunction is a major cause of bradycardia necessitating pacemaker implantation. Evidences of genetic study supported that some genes involved in the pacemaker current or renin-angiotensin system were related to sinus node dysfunction. However, the influence of gene polymorphisms on sinus node dysfunction was not well studied.

Methods: A group of 100 patients with documented sinus node dysfunction and 100 age- and sex- matched healthy control patients will be enrolled into this study. Gene polymorphism study includes the angiotensin-I converting enzyme gene, angiotensin II type 1 receptor gene, HCN1-4, SCN5A, KCNE and other possible gene polymorphisms which are related to sinus node function based on previous reports. Genetic polymorphisms are identified with polymerase chain reaction-based restriction analysis. Comparison of multiple haplotype analysis and single-locus analysis will be analyzed between the cases and controls.

Estimated Results: Some genetic polymorphisms of these genes which are related to sinus node function or rennin-angiotensin system will show association with sinus node dysfunction. In multilocus haplotype analysis, some genetic haplotype profiles may demonstrate significant difference between cases and controls. In single locus analysis, some genetic polymorphisms may be associated with sinus node dysfunction.

Estimated Conclusion and Clinical Implication: This study will demonstrate the genetic polymorphisms in RAS genes or some other genes associated with sinus node dysfunction. These results will support the roles of these genetic polymorphisms in determining the risk of sinus node dysfunction among the Chinese population in Taiwan.


Eligibility criteria: Inclusion Criteria:

1. Heart rate was less than 40/min or long pause more than 3 seconds in series EKG or 24-hour EKG.
2. Sinus nodal recovery time exceeds 1600 ms in cardiac electrophysiology study.

Exclusion Criteria:

1. Severe systemic disease.
2. Acute coronary syndrome.
3. Bradycardia with reversible cause.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Jan-Yow Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02425423: Study on the Tolerance and Efficacy of a New Anti Regurgitation Formula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux
Lead sponsor: United Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-04-24
Enrollment: 100
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the efficacy of a new thickened formula on regurgitation.


Eligibility criteria: Inclusion Criteria:

Infants :

* Aged ≤ 5 months old
* fully formula fed
* with at least 5 episodes of regurgitation per day

Exclusion Criteria:

* Breast fed infants
* Infants presenting symptoms of a complicated gastroesophageal reflux
* Infants presenting intestinal disorders

Primary outcomes:
measure: Number of episodes of regurgitation per day
timeFrame: 14 days
Secondary outcomes:
measure: Regurgitation score
timeFrame: 14 days
measure: Regurgitation score
timeFrame: 3 months
measure: Digestive tolerance (stools' number and consistency)
timeFrame: 14 days
measure: Digestive tolerance (stools' number and consistency)
timeFrame: 3 months
measure: Growth parameters (Weight, height and head circumference)
timeFrame: 3 months
Other outcomes:
Locations:
city: Belgium
country: Belgium
facility: Pediatricians
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis
city: France
country: France
facility: Pediatricians
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Yvan Vandenplas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00550823: Cardiac Computarized Tomography in Infective Endocarditis
Official title: The Use of Cardiac Computarized Tomography in Infective Endocarditis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infective Endocarditis
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The diagnosis of infective endocarditis is based on the results of blood culture and findings on transeosophageal echocardiography. Cardiac computarized tomography is a new modality, mainly used for the imaging of coronary arteries. Its use in the diagnosis of infective endocarditis is not well known.The purpose of this study is to establish the use of cardiac CT in infective endocarditis.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with infective endocarditis

Exclusion Criteria:

* Allergy to contrast agent

Primary outcomes:
measure: The diagnostic capacity of cardiac CT in comparison with TEE in the diagnosis of infective endocarditis
timeFrame: 1 year
Secondary outcomes:
measure: Assessment of cardiac function in patients with infective endocarditis
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Ori Elkayam, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03094923: Effects of Respiratory Muscle Training on Postoperative Pulmonary Complications of Cardiac Surgery
Official title: Effects of Preoperative Inspiratory Muscle Training on Functional Capacity and Pulmonary Complications in Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Coronary Disease
Cardiovascular Diseases
Coronary Artery Occlusion
Lead sponsor: University of the State of Santa Catarina
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the profilatic effects of inspiratory muscle training (IMT) on functional capacity, respiratory muscle strength, postoperative pulmonary complications and days of hospitalization (PPC) in patients submitted to coronary artery bypass graft surgery (CABG).

Detailed description: Patients undergoing coronary artery bypass graft surgery are at risk of postoperative pulmonary complications, which lead to increased postoperative morbidity and mortality.

A few studies have demonstrated that preoperative physical therapy has advantages over postoperative care in patients undergoing cardiac . In this way, this study aim to investigate the effects of preoperativeinspiratory muscle training in patients at high risk of postoperative pulmonary complications who were scheduled for coronary artery bypass graft surgery.

Eligibility criteria: Inclusion Criteria:

* High-risk patients underwent primary elective CABG (Coronary artery bypass graft), High-risk will be defined as 2 or more the following: age\>70 years; cough and expectoration; diabetes; smoker; COPD (Chronic Obstructive Pulmonary Disease)

Exclusion Criteria:

* Uncontrolled arrhythmia,
* Decompensated heart failure,
* Unstable angina upon selection or during the inspiratory muscle training (IMT),
* Need for reoperation and association of another procedure during surgery (e.g. valve correction associated with CABG)
* Severe orthopedic or neurological conditions.

Primary outcomes:
measure: Postoperative Pulmonary Complications
timeFrame: 1 month
Secondary outcomes:
measure: Respiratory Muscle Strenght
timeFrame: 1 month
measure: Functional Capacity
timeFrame: 1 month
measure: Lenght of hospital stay hospitalization
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03514823: Respiratory Muscle Contribution to Blood Pressure During Exercise
Official title: Respiratory Muscle Contribution to Blood Pressure During Exercise in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Muscle
Blood Pressure
Exercise Capacity
Sympathetic Nerve Activity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-02
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The investigators seek to understand how reflexes from the breathing muscles influence blood pressure during exercise. Furthermore, the investigators are determining if increasing breathing muscle strength (via inspiratory muscle training) influences the respiratory muscle contribution to blood pressure during exercise.


Eligibility criteria: Healthy participants with no history of cardiovascular, pulmonary, neurologic, orthopedic or other neuromuscular diseases.

Primary outcomes:
measure: VO2 max test
timeFrame: Through study completion, an average of one year.
measure: Blood Pressure
timeFrame: Through study completion, an average of one year.
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Thomas P Olson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02872623: EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study
Official title: EnteroCT With Enteroclysis Versus Enterography-MRI for the Diagnosis of Tumors of the Small Intestine: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suspicion of Tumor of the Small Intestine
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Early diagnosis of tumors of the small intestine is a challenge for clinicians and for radiologists. The detection of tumors of the small intestine is a field in which the video capsule endoscopy has the lowest performance.

The entero-CT with enteroclysis is the imaging technique used primarily to explore patients with a strong suspicion of small intestine tumors. However the entero-CT with enteroclysis has disadvantages : it is irradiating, the nasojejunal tube implies a discomfort to the patient and it is a complicated examination in terms of logistics with necessity of specific equipment to insert the nasojejunal tube.

MRI has been proposed as an alternative imaging technique and satisfactory results have been reported with the MRI enteroclysis. However, this technique has several disadvantages related to nasojejunal tube insertion and the necessity of equipment compatible with the high magnetic fields. The enterography-MRI without enteroclysis, whose principle is to distend the small intestine by ingestion of large quantities of a liquid, has a major and undisputed role in the exploration of Crohn's disease of the small bowel. However, its capacity for distension of the small intestine for optimal tumor detection is questioned and its role in tumor detection is largely unknown.

Detailed description: Evaluate the diagnostic performances of enteroCT with enteroclysis and enterography-MRI without enteroclysis, for the diagnosis of tumor of the small intestine, among patients with suspicion of small intestine tumors.

Eligibility criteria: Inclusion Criteria:

* patient clinically suspected of having a tumor of the small intestine
* patient consenting to participate to the study
* patient enrolled in the national healthcare insurance program
* patient older than 18 years

Exclusion Criteria:

* patient with inflammatory bowel disease
* patient with contraindication for MRI

Primary outcomes:
measure: Presence of a tumor of the small intestine
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu de Reims
Study officials:
References:
Clinical trial NCT00266123: Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients
Official title: A Randomized Open-Label Study to Compare the Safety and Efficacy of Two Different Sirolimus Regimens With a Tacrolimus + Mycophenolate Mofetil Regimen in De Novo Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Graft Rejection
Kidney Failure
Kidney Transplant
Keywords: Kidney Failure
Kidney Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-12-15
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years.
* End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match.
* Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusions apply.

Exclusion Criteria:

* Evidence of active systemic or localized major infection.
* Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF.
* Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).

Other exclusions apply.

Primary outcomes:
measure: Kidney function at 52 weeks after transplantation.
Secondary outcomes:
measure: Kidney function at 26, 78 and 104 weeks after transplantation
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth Reseach
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Belgium, trials-BEL@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, MedinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Poland, WPWZMED@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Switzerland, med@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For United Kingdom, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01233323: Detection of Phrenic Nerve Stimulation Using Sensors' Signals
Official title: Detection of Phrenic Nerve Stimulation Using Accelerometer and Electrogram Signals Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Phrenic nerve stimulation
Cardiac Resynchronization Therapy
Heart Failure
Heart Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients implanted with a COGNIS™ CRT-D device

Brief summary: The purpose of this study is to collect sensor data from patients with implanted cardiac resynchronization devices who exhibit phrenic nerve stimulation.


Eligibility criteria: Inclusion Criteria:

* Willing and capable of providing informed consent and of participating in all testing
* Age 18 or above or of legal age to give informed consent specific to national law
* Implanted with a Boston Scientific COGNIS™ family device
* Geographically stable and is available for follow-up procedures at a study centre

Exclusion Criteria:

* Patients that are pacemaker-dependent
* Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion)
* Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry
* Patients who are not expected to support approximately 30 minutes of study testing procedures
* Patients who are not mentally competent enough to provide feedback on PS during study procedures

Primary outcomes:
measure: Data collection
timeFrame: 3 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
Study officials:
affiliation: Heart Institute, Sheba Medical Center, Tel Hashomer, Israël
name: Michael Glikson, MD
role: PRINCIPAL_INVESTIGATOR
References: