louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01512043: Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: Breathing Control in Patients With Chronic Obstructive Pulmonary Disease (COPD) Intervention With Device-guided Breathing Control in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Breathlessness
Symptoms
Quality of life
Lead sponsor: Lovisenberg Diakonale Hospital
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Norwegian Foundation for Health and Rehabilitation
name: University of Bergen
First posted: 2012-01-19
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: There is a demand for explorative and comparative studies on various non-pharmaceutical efforts in treating and helping chronic obstructive pulmonary disease patients. This study has been developed in light of this need. The main purpose of the project is to test whether a device guided breathing control system can decreasing the feeling of breathlessness in patients with moderate stage and severe stage of COPD. In addition the study could shed light on whether a reduced feeling of breathlessness can lead to improved physical function, and less experience of other symptoms (I.e., depression, anxiety, sleeping difficulties, fatigue, pain) and provide a better quality of life for patients with COPD.


Eligibility criteria: Inclusion Criteria:

* Dyspnoea symptoms in daily life
* Spirometry values showing a COPD moderate stage II (FEV1/FVC\<70%, FEV1\<80%) and severity grade at a severe stage III (FEV1/FVC\<70%, FEV1\<50% and FEV1 = 30% of a predicted)
* Be able to read, write and speak Norwegian
* Be at a stable phase of the disease

Exclusion Criteria:

* Changes in pulmonary medication during the last 4 weeks
* Diagnosis of cancer
* Presently attending a pulmonary rehabilitation course or other similar COPD education courses (due to the fact that these courses often have instructions on breathing control), or having attended similar courses during the last six months
* Ongoing exacerbation
* Attending other competitive studies
* Diagnosis of neuromuscular disease
* Diagnosis of dementia
* Attending help from a pulmonary physiotherapist

Primary outcomes:
measure: Breathlessness
timeFrame: 4 months
Secondary outcomes:
measure: Depression
timeFrame: 4 months
measure: Pulmonary functional tests
timeFrame: 4 months
measure: Anxiety
timeFrame: 4 months
measure: Fatigue
timeFrame: 4 months
measure: Sleeping difficulties
timeFrame: 4 months
measure: Pain
timeFrame: 4 months
measure: 6. Min walk test
timeFrame: 4 months
measure: Arterial blood gas measures
timeFrame: 4 months
measure: Quality of life
timeFrame: 4 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Hospital
Study officials:
affiliation: University of Oslo
name: Astrid K Wahl, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01908790: Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter and Central Venous Catheter
Official title: Correlation of Venous Oxygen Saturation Measurements by Non-invasive Mespere Venous Oximeter vs Venous Oxygen Saturation From Blood Samples From the Jugular Vein vs Central Venous Oxygen Saturation vs Mixed Venous Oxygen Saturation, Measured by a CO-Oximeter.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Validation of Oximeter System
Keywords: venous oximeter
non-invasive monitor
heart failure (HF)
Lead sponsor: Mespere Lifesciences Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2013-07-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute and chronic heart failure patients already receiving right heart catheterization (RHC) as part of their usual care

Brief summary: The purpose of this study is to establish the accuracy of the non-invasive Mespere Oximeter that estimates venous oxygen saturation.

Detailed description: The conventional pulse oximeter has been a standard in clinical care for non-invasive hemodynamic monitoring, which only measures arterial blood oxygenation. The clinical application of venous oximetry is numerous, including severe sepsis and septic shock, severe trauma and hemorrhagic shock, and heart failure and cardiac arrest.

The existing method for venous blood oxygenation monitored is either through an invasive fiber optic catheter, or intermittently by blood sampling and CO-Oximetry. However, catheterization can be costly and can include inherent risks. Therefore, due to the inherent risks of catheterization, venous oximetry is limited only to critically ill patients.

By non-invasively monitoring venous blood oxygenation, the Mespere Oximeter provides more complete information on patient hemodynamics.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Heart failure patients already receiving RHC as part of their usual care
* Signed written and informed consent

Exclusion Criteria:

* Lack of patient consent
* Subject is pregnant
* Evidence of abnormal neck anatomy
* Subject does not have visible left and right jugular veins
* Subject has occluded internal jugular veins under ultrasound imaging
* Allergic to adhesive tape
* Ongoing photodynamic therapy
* Presence of known anatomical shunt or AV dialysis fistula
* Known central vein stenosis

Primary outcomes:
measure: Mespere Oximeter venous oxygen saturation accuracy compared to CO-Oximeter
timeFrame: 0-10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Cardiovascular Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Todd M Koelling, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162290: Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program
Official title: Comparison Between Moderate-high Interval Exercise and Moderate Continuous Exercise in an Advanced Cardiac Rehabilitation Program - Nine Months Follow up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Myocardial Infarction
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-06-12
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The research will study the differences between interval training and continuous training among cardiac patients in a cardiac rehabilitation facility.

The main objectives are:

1. Functional capacity measures (VO2 max).
2. Cardiac risk factors
3. Quality of life assessments.

Study hypothesis:

Interval training will be more effective in improving functional capacity, cardiac risk factors and quality of life, compared to continuous training.


Eligibility criteria: Inclusion Criteria:

* Patients undergone:

  * Myocardial infarction
  * Percutaneous transluminal coronary angioplasty
  * Coronary artery bypass graft

Exclusion Criteria:

* Patients with:

  * Severe ischemia or angina
  * Implantable cardioverter-defibrillator
  * Pacemakers transplants
  * Severe left ventricular dysfunctions
  * Uncontrolled arrhythmias

Primary outcomes:
measure: Maximal functional capacity
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beer Yaacov
country: Israel
facility: Asaf Harofe Medical Center
Study officials:
affiliation: Asaf Harofe Medical Center
name: Yael Pernick
role: PRINCIPAL_INVESTIGATOR
affiliation: Asaf Harofe Medical Center
name: Zyssman, MD
role: STUDY_DIRECTOR
affiliation: Bangor University
name: Jonathan Moore, PhD
role: STUDY_DIRECTOR
affiliation: Asaf Harofe Medical Center
name: Zvi Vered, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06314490: Personalized Antisense Oligonucleotide Therapy for Rare Pediatric Genetic Disease: SCN2A
Official title: Personalized Antisense Oligonucleotide Therapy for Rare Pediatric Genetic Disease: SCN2A
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Genetic Disease
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: California Institute for Regenerative Medicine (CIRM)
name: n-Lorem Foundation
First posted: 2024-03-18
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research project entails delivery of a personalized antisense oligonucleotide (ASO) drug designed for a single pediatric participant with SCN2A associated developmental epileptic encephalopathy

Detailed description: This is an interventional study to evaluate the safety and efficacy of treatment with an individualized antisense oligonucleotide (ASO) treatment in a single pediatric participant with a de novo pathogenic gain of function SCN2A mutation associated with severe developmental epileptic encephalopathy.

Eligibility criteria: Inclusion Criteria:

* Informed consent provided by the participant's parent(s)/guardian(s)
* Ability to travel to the study site, adhere to study-related follow-up examinations and/or procedures, and provide access to participant's medical records.
* Genetically confirmed mutation

Exclusion Criteria:

• Use of an investigational medication within less than 5 half-lives of the drug at enrollment

Primary outcomes:
measure: Seizure frequency
timeFrame: Baseline to 24 months
measure: Motor function as measured by Dyskinetic Cerebral Palsy Functional Impact Scale
timeFrame: Baseline to 24 months
measure: Motor function as measured by the motor skills domain of Vineland Adaptive Behavior Scales
timeFrame: Baseline to 24 months
measure: Motor function as measured by the motor skills domain of Bayley Scales of Infant and Toddler Development
timeFrame: Baseline to 24 months
measure: Gastrointestinal assessment as measured by the Bristol Stool Chart
timeFrame: Baseline to 24 months
Secondary outcomes:
measure: Neurodevelopmental Function as measured by Aberrant Behavior Checklist
timeFrame: Baseline to 24 months
measure: Neurodevelopmental Function as measured by Observer-Reported Communication Ability Measure
timeFrame: Baseline to 24 months
measure: Neurodevelopmental Function as measured by the Vineland Adaptive Behavior Scales
timeFrame: Baseline to 24 months
measure: Neurodevelopmental Function as measured by the Bayley Scales of Infant and Toddler Development
timeFrame: Baseline to 24 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital
state: California
Study officials:
affiliation: UCSD Rady Children's Hospital
name: Olivia Kim-McManus, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05028790: Evaluating Contact Lens Optics
Official title: Evaluating Contact Lens Optics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens


Eligibility criteria: Inclusion Criteria:

* Able to read and understand the informed consent document
* 18 to 39 years of age (inclusive)
* Best corrected visual acuity of 20/25 or better in the right eye
* Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)

Exclusion Criteria:

* Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
* History of ocular trauma or surgery causing abnormal or distorted vision
* Current Rigid Gas Permeable (RGP) contact lens wearers
* Unwilling to have contact lens fit photographed
* Pregnant and/or lactating females, by self-report

Primary outcomes:
measure: Visual Performance
timeFrame: Through completion of study visit, an average of 2.5 hours
Secondary outcomes:
measure: Spherical Equivalent Refractive Error On-axis
timeFrame: Through completion of study visit, an average of 2.5 hours
measure: Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina
timeFrame: Through completion of study visit, an average of 2.5 hours
measure: Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina
timeFrame: Through completion of study visit, an average of 2.5 hours
measure: Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina
timeFrame: Through completion of study visit, an average of 2.5 hours
measure: Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina
timeFrame: Through completion of study visit, an average of 2.5 hours
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Houston
state: Texas
Study officials:
affiliation: University of Houston College of Optometry
name: David A Berntsen, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580190: Evaluation Of PF-00572778 And Alprazolam On Naloxone Challenge In Healthy Subjects
Official title: A Phase I, Randomized, Placebo Controlled, Parallel Group, Single Dose Study To Evaluate The Effects Of PF-00572778 And Alprazolam On A Naloxone Challenge In Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-24
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PF-00572778, a CRH antagonist, is expected to attenuate adrenocorticotropin (ACTH) and cortisol responses to naloxone by blocking the effect of the CRH increases induced by naloxone at the postsynaptic receptors. Demonstration of a statistically significant attenuation of naloxone induced increases in cortisol and/or ACTH concentrations by PF-00572778 compared to placebo would thus constitute proof of mechanism for the compound. Therefore, this study is to evaluate pharmacodynamic effects of PF-00572778 following naloxone challenge in healthy subjects.


Eligibility criteria: Inclusion Criteria:

Healthy male and/or female subjects between the ages of 18 and 45 years; Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease; Family (1st degree relatives) and personal history of meeting Diagnostic and Statistical Manual -IV (DSM-IV) criteria for alcohol abuse or dependence.

Primary outcomes:
measure: Area under the cortisol concentration time curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
timeFrame: 1st day on treatment
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: 1st day on treatment
measure: Time to reach the maximum observed serum concentration (Tmax)
timeFrame: 1st day on treatment
measure: Safety laboratory tests, vital signs, ECGs, adverse events monitoring, and physical<br>examinations
timeFrame: 34 days (weekly)
measure: Peak concentrations for plasma cortisol and ACTH
timeFrame: 1st day on treatment
measure: Area under the concentration-time curve from time = 0 to time of the last quantifiable serum PF-00572778 concentration (AUClast)
timeFrame: 2nd day on treatment (Days 6-7)
measure: Area under the ACTH concentration curve from 0 to 3 hours ( AUC(0-3) ) following naloxone challenge
timeFrame: 1st day on treatment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05005390: Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway
Official title: Comparison of Effectiveness of Mask Ventilation and Endotracheal Tube in Pharynx (TTIP) in Patients With Potential Difficult Airway:A Prospective Randomized and Blinded Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation Therapy; Complications
Keywords: Bag Mask Ventilation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy of TTIP-first ventilation and to compare the efficacy of TTIP first ventilation with the current practice of mask-first ventilation


Eligibility criteria: Inclusion Criteria:

* BMI \>30 kg/m2
* Mallampati class III or IV
* Requiring general anesthesia

Exclusion Criteria:

* Acute and chronic respiratory disorders, including Chronic obstructive pulmonary disease(COPD)and asthma
* American Society of Anesthesiologists (ASA)physical status classification ≥IV
* Emergency surgery
* Induction requiring rapid sequence for intubation
* Patients requiring awake intubation
* Pregnant women
* Untreated ischemic heart disease
* Contraindication for mask ventilation

Primary outcomes:
measure: Number of Patients With Successful Ventilation
timeFrame: from start of ventilation to end of ventilation (about 1 minute)
Secondary outcomes:
measure: Expired Tidal Volume of Ventilation
timeFrame: from start of ventilation to end of ventilation (about 1 minute)
measure: Peak Inspiratory Airway Pressure Achieved
timeFrame: from start of ventilation to end of ventilation (about 1 minute)
measure: Dynamic Airway Resistance
timeFrame: from start of ventilation to end of ventilation (about 1 minute)
measure: Satisfaction of the Providers Obtained With Post Ventilation Survey
timeFrame: Baseline before start of surgery
measure: Satisfaction of the Providers Obtained With Post Ventilation Survey
timeFrame: end of surgery (about 1 hour after start)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Travis Markham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02970890: Effects of Photobiomodulation Therapy (PBMT) in Total Hip Arthroplasty
Official title: Effects of Photobiomodulation Therapy (PBMT) on Acute Pain and Inflammation in Patients Who Underwent Total Hip Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Hip
Keywords: Total Hip Arthroplasty (THA)
Phototherapy
Low-level laser therapy
Light-emitting diodes
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 18
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA), a chronic degenerative muscle disease characterized by cartilage wear, causes progressive joint deformity and loss of function leading to the indication of total hip arthroplasty (THA), when conservative treatments fail. Surgical trauma leads to pain and induces an immune response. Photobiomodulation therapy (PBMT) has proven effective in tissue repair by modulating the inflammatory process and promoting pain relief. It can therefore be part of the treatment. This study aims to analyze the effect of PMBT on inflammation and pain of patients who underwent total hip arthroplasty. The study consisted of eighteen patients who underwent hip arthroplasty and they received phototherapy in a period from 8 to 12 hours after surgery. We divided the patients into two groups (n=9 each) placebo and effective phototherapy. The patients were evaluated before and after phototherapy with 9 diodes, applied to 5 points along the scar (1 laser 905nm, 4 LEDs 875nm and 4 LEDs 640nm, 40.3J total), by visual analogue scale (VAS) and blood collection for analysis of the levels of the cytokines TNF-α, IL-6 and IL-8.


Eligibility criteria: Inclusion Criteria:

- Men and women with clinical diagnosis of OA based on radiological images in the anteroposterior and profile according to Demur classification.

Exclusion Criteria:

- Men and women with other clinical diagnosis

Primary outcomes:
measure: Evaluation of Pain (VAS)
timeFrame: Change from baseline in VAS to immediately after phototherapy
measure: Evaluation of Cytokines levels (ELISA immunoenzymatic assay)
timeFrame: Change from baseline in Cytokines levels to immediately after phototherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Beneficência Nossa Senhora do Pari
state: SP
Study officials:
References:
Clinical trial NCT02635490: Is Prophylactic Antibiotics Necessary In Otherwise Healthy Adult Patients Undergoing Ureteroscopic Procedures for Ureteral Stones?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureteral Stones
Keywords: prophylactic antibiotics, urinary tract infection.
Lead sponsor: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort study

Brief summary: The present study aims to investigate the relative efficacy, safety and risk of a single-dose prophylaxis in otherwise healthy adult patients undergoing ureteroscopic procedures for ureteral stones.


Eligibility criteria: Inclusion Criteria:

* 100 otherwise healthy adult patients.
* Aged from 20 to 65 years.
* Undergoing ureteroscopic procedures for ureteral stones.

Exclusion Criteria:

* Have the urine road the infection before the surgical operation, the surgical operation once took antibiotics the first 2 week.
* Pregnant or the women been breast feeding.

Primary outcomes:
measure: Evidence of clinically definite urinary tract infection confirmed by urinary analysis or urinary culture.
timeFrame: within the first 10 days (plus or minus 5 days) after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng-Hsing Hsieh
state: Xindian
Study officials:
References: