louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02884973: Prospective Evaluation of Changes in Tissue Oxygen Saturation in Brain and Kidney in Children Admitted to Intensive Care in the Postoperative Period of Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Heart Defect
Keywords: congenital heart
NIRS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 30
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged under 5 years who underwent cardiac surgery (palliative or curative) and postoperative hospital period in pediatric resuscitation

Brief summary: It is estimated that the incidence of congenital heart disease varies between 0.5 and 1% of live births, 5,000 new cases per year currently in France These are serious diseases that can be life-threatening to more or less short term.

The advances in surgical techniques in recent years has improved the prognosis of these patients in the first months of life.

The success of surgery is, among other things, conditioned by a support per complex operation, involving a multimodal intensive monitoring, and respiratory and hemodynamic support techniques.

These elements of surveillance, NIRS (Near-infrared spectroscopy) allows measurement of non-invasive tissue saturation (rSO2) in cerebral and renal oxygen.

The fundamental principle of NIRS based on an estimate of the percentage proportion of cerebral oxy-hemoglobin.

A light source is emitted by NIRS and through body tissues to the brain where the light will be absorbed and refracted depending on the tissue composition in oxy-hemoglobin.

Refracted light will be analyzed by NIRS which in turn using software will help to determine a percentage of oxyhemoglobin.

Normal values of cerebral NIRS are between 50 and 80%.NIRS can be used according to this principle to estimate cerebral tissue oxygenation but also for other tissues such as the kidney.

More than the figure, those are changes NIRS compared to a baseline that will alert us to the conditions of tissue oxygenation and allow us to identify hypoxia times.

Changes in the value of the NIRS depends on 3 criteria: the tissue blood flow, the percentage of oxyhemoglobin and deoxyhemoglobin percentage.


Eligibility criteria: Inclusion criteria

* Children under 5 years
* Allowed in pediatric intensive care unit
* Having received heart surgery for management of congenital heart disease

Exclusion criteria

* Patients aged over 5 years
* Violations preexisting brain to the intervention (brain malformation)
* Patients with congenital heart disease and admitted to intensive care for reasons other than the surgical treatment of heart disease

Primary outcomes:
measure: oxygen saturation in brain and kidney tissue
timeFrame: 1 hour after cardiac surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00678873: Single Incision Laparoscopic Cholecystectomy
Official title: Single Incision Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cholelithiasis
Keywords: Single Incision
Single Access
Surgery
Cholecystectomy
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2008-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.

The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.

Detailed description: Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction.

In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).

Eligibility criteria: Inclusion Criteria:

* Adults male and female(\>18 years old)
* Capable of giving informed consent
* Ultrasound proven cholelithiasis
* Symptomatic cholelithiasis
* Elective cholecystectomy

Exclusion Criteria:

* Pregnancy
* Contraindications for general anesthesia
* Morbid obesity
* Multiple previous abdominal surgeries
* Uncontrolled medical conditions
* Acute cholecystitis

Primary outcomes:
measure: Safety and feasibility
timeFrame: 12 months
Secondary outcomes:
measure: Short-term clinical outcomes
timeFrame: 12 months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
Study officials:
affiliation: UTSouthwestern
name: Homero Rivas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01266473: Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.
Official title: Efficacy Study of Physiotherapy for Airway Clearance in Cystic Fibrosis. Randomized Controlled Trials in Single Subjects (N of 1 RCT's).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Adults
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2010-12-24
Enrollment: 6
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 investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.


Eligibility criteria: Inclusion Criteria:

* Diagnosis: CF
* Age \>18 years
* Amount of sputum \>5 ml/60 min
* Wet inhalation of saline/DNase/both
* Informed consent

Exclusion Criteria:

* Respiratory failure
* Hemoptysis
* Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
* Ongoing intravenous medication
* Pregnancy

Primary outcomes:
measure: Expectorated sputum (gram)
timeFrame: 8 weeks
Secondary outcomes:
measure: Patient's experience, i.e. perceived utility value and preference of technique.
timeFrame: 8 weeks
Other outcomes:
measure: Physiological measurements
timeFrame: 8 weeks
measure: Health related quality of life (HRQOL)
timeFrame: 8 weeks
Locations:
Study officials:
affiliation: Oslo University Hospital, National Centre for cystic fibrosis
name: Sandra Gursli, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gursli S, Quittner A, Jahnsen RB, Skrede B, Stuge B, Bakkeheim E. Airway clearance physiotherapy and health-related quality of life in cystic fibrosis. PLoS One. 2022 Oct 18;17(10):e0276310. doi: 10.1371/journal.pone.0276310. eCollection 2022.
Clinical trial NCT05061173: Comparison of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
Official title: Compare the Effects of Aerobic, Resistance, and Combined Training in Overweight/Obese Hypertensive Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Hypertension
Keywords: Aerobic Exercise
Resistive exercise
Combined Aerobic and Resistive Exercise
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 63
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the effects of aerobic, resistance and combined training in hypertensive obese patients


Eligibility criteria: Inclusion Criteria:

* Hypertensive with BP greater than 140/90 mmHg
* Overweight and obese adults with BMI (25-40)
* Physically inactive from past 6 months assessed with pedometer. Those with step count of less than 7000 will be included
* To be able to exercise (6MWT),t hose who completed the test without any symptom

Exclusion Criteria:

* Any active systemic illness that restricts exercise
* People doing exercise on regular basis
* Any cardiopulmonary , metabolic and neurological illness

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 6 weeks
measure: Body Mass Index (BMI)
timeFrame: 6 Week
measure: Change in blood lipid profile
timeFrame: 6 Week
measure: Step Count
timeFrame: 6 week
measure: Waist circumference
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Kotli
country: Pakistan
facility: District Headquarter Hospital - kotli
state: Azad Jamu Kashmir
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01545973: Understanding the Physiological Implications of Scanning Kelvin Probe Measurements
Official title: Measuring Skin Electrical Potential With the Kelvin Probe: Underlying Physiology
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Healthy Individuals
Skin Electrical Potential
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy Volunteers

Brief summary: The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.

Detailed description: The Scanning Kelvin Probe measures the electrical potential of material surfaces without actually touching it. Although this technology has been applied to non-living materials (e.g. metal and semiconductors) before, it has not been effectively applied to biological materials, much less to live human skin . This project aims to evaluate the use of Scanning Kelvin Probe to live human skin by investigating the effects of skin thickness, skin moisture, and sweat glands on Kelvin Probe measurements of electrical potential. Testing will be performed on the arms and hands of twenty four healthy individuals under different study conditions.

Eligibility criteria: Inclusion Criteria:

* "Healthy" is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)

Exclusion Criteria:

* autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker

Primary outcomes:
measure: Surface Electrical Potential
timeFrame: 1 day
Secondary outcomes:
measure: Electrical Impedance
timeFrame: One day
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital - Martinos Center for Biomedical Imaging
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew C. Ahn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257073: Cognitive-behavioral Treatment for Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Chengdu PLA General Hospital
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness of Cognitive-behavioral treatment for people with rheumatoid arthritis


Eligibility criteria: Inclusion Criteria:

* diagnosed by rheumatology consultants with RA

Exclusion Criteria:

* severe psychological difficulties
* currently receiving mental health care
* any medical condition that might prevent them from safely exercising (e.g. history of more severe heart, lung or cerebrovascular disease)
* previously attended an education programme
* had a Modified Health Assessment Questionnaire score \>2 (score range 0-3), that is severe functional problems
* history of organic brain syndrome
* presence of a psychotic disorder
* presence of other uncontrolled medical disorders
* presence of a major communication disorder, illiteracy
* presence of less than an 8th grade education (due to inability to complete questionnaires)
* presence of a therapeutic dosage of an antidepressant medication, or presence of another autoimmune disease/disabling condition

Primary outcomes:
measure: Changes from baseline in disease activity score in 28 joints(DAS28) at 48 weeks
timeFrame: at 0 week, 12 weeks, 24 weeks, 48 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: General Hospital of Chengdu Military Area Command PLA
state: Sichuan
Study officials:
References:
Clinical trial NCT03654573: The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment
Official title: The MOCA I Study - Microvascular Obstruction with CoFI™ System Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: STEMI - ST Elevation Myocardial Infarction
Microvascular Obstruction
Lead sponsor: CorFlow Therapeutics AG
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: N= 50 Diagnostic and N= 20 Therapeutic
Primary purpose: OTHER

Brief summary: First-in-Human study to assess the CoFI™ device related safety and the feasibility of the diagnostic and the therapeutic sequence as well as the correlation between the dynamic microvascular resistance (dMVR) and microvascular obstruction (MVO) as measured by MRI in patients presenting with acute ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).


Eligibility criteria: Major Inclusion Criteria:

* Patients 18 years of age or older presenting with ST-elevation myocardial infarction in the left anterior descending artery (LAD) undergoing primary percutaneous coronary intervention.
* Competent mental condition to provide signed and dated ethics committee approved study consent prior to study related procedures
* Eligible for prasugrel, ticagrelor, cangrelor, tirofiban, UFH and GP IIb/IIIa inhibitors
* Referred for primary PCI within 5 hours of symptom onset with evidence of continuing ischemia and symptom to balloon time not exceeding 6 hours

Major Exclusion Criteria:

* Unconsciousness
* Previous bypass graft surgery
* Contraindication to CMRI
* Recent or current major bleeding within 30 days prior to intervention
* Recent major surgery within 30 days prior to intervention
* End-stage heart failure with inotrope support and/or consideration for LVAD or heart transplant
* Transient ischemic attack or stroke within 30 days prior to intervention
* Pregnant or females of childbearing potential

Primary outcomes:
measure: The incidence of study device or study procedure adverse effect or event
timeFrame: up to 30 days
Secondary outcomes:
measure: Diagnostic Success
timeFrame: 0 days
measure: Therapeutic Success
timeFrame: 0 days
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: The Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
state: TI
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneva
country: Switzerland
facility: HUG Geneva
city: Lausanne
country: Switzerland
facility: CHUV Lausanne
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Lukas Hunziker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01475773: Psychological Assessment of Adults Seeking Orthodontic Treatment
Official title: Impact of Personality Characteristics and Self-esteem on the Relationship Between Orthodontic Treatment Need and Oral-health Related Quality of Life in Adults.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Self-esteem
Personality
Quality of Life
Malocclusion
Orthodontics
Keywords: self-esteem
personality
quality of life
malocclusion
orthodontics
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-11-21
Enrollment: 100
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults (starting from age 17) seeking orthodontic treatment on the first consultation of our clinic (university hospital Leuven)

Brief summary: Is their a association between the objective and subjective severity of a malocclusion, quality of life and self-esteem/personality (as modifier between objective/subjective severity and quality of life (cfr study Agou et al., 2008) ? A second goal is to compare motivation and expectations and the objective and subjective severity of the malocclusion on the other hand.


Eligibility criteria: Inclusion Criteria:

* good health,
* thorough knowledge of the Dutch language

Exclusion Criteria:

* language

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital of Leuven
Study officials:
References:
citation: Agou S, Locker D, Streiner DL, Tompson B. Impact of self-esteem on the oral-health-related quality of life of children with malocclusion. Am J Orthod Dentofacial Orthop. 2008 Oct;134(4):484-9. doi: 10.1016/j.ajodo.2006.11.021.
Clinical trial NCT05308173: Aortic Valve replAcement in eLective Patients From aOrtic Valve multiceNter Registry
Official title: Surgical and Transcatheter Aortic Valve Replacement for Aortic Stenosis in Low-risk Elective Patients. Data From Multicenter Registry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: Nicolaus Copernicus University
Sponsor class: OTHER
First posted: 2022-04-01
Enrollment: 2393
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective aortic valve replacement (AVR) for severe AS, regardless of the aortic regurgitation (AR) severity.

Brief summary: Multicenter registry data analysis of aortic valve stenosis patients that underwent elective, isolated transcutaneous aortic valve implantation (TAVI) or surgical aortic valve replacement between 2015 and 2019. In TAVI group only transfemoral access was considered.

Detailed description: A retrospective analysis of the Multicenter Aortic Valve Registry patients operated between 2015 and 2019 in the three departments of cardiac surgery in Poland: the Medical University of Silesia in Katowice, Medical University in Gdańsk, and Poznań, University of Medical Science. Baseline clinical, procedural, and outcome data at follow-up were entered into prespecified electronic case report forms. Follow-up status was validated by personal contact or access to Polish National Health Fund. Patients with planned concomitant intervention on coronary arteries (by bypass grafting or percutaneous intervention), other valvular interventions, arrhythmia ablation, or left atrial appendage occlusion were excluded too. In TAVI group only femoral access was considered. For SAVR any tissue or mechanical valve implantation in an aortic position with sternotomy or minimal access was included.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Elective procedure
* Aortic valve replacement with means of TAVI or SAVR

Exclusion Criteria:

* Concomitant procedures

Primary outcomes:
measure: all-cause death
timeFrame: up to 6 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01230073: Treatment Satisfaction in Implantable Cardioverter Defibrillator Recipients
Official title: Treatment Satisfaction With Remote Monitoring in Implantable Cardioverter Defibrillator Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Improvement of Treatment Satisfaction
Keywords: ICD
Home-Monitoring
Quality of life
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2010-10-28
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Remote monitoring of implantable cardioverter defibrillators (ICD) is a promising new development in ICD therapy and has been shown to be technically feasible and safe.While data on safety and feasibility of remote monitoring are in favour of this technology, patients´ treatment satisfaction has not been sufficiently investigated. To date, there is only one small, non-randomised study investigating patients´ treatment satisfaction in highly selected and highly motivated patients at the time of implantation and 12 months thereafter7. Therefore, the aim of the San Remo Trial is to investigate factors that are associated with patients´ willingness to accept the new method of follow-up on a broad basis of ICD recipients and to determine their treatment satisfaction with ICD therapy in a randomised, prospective trial.


Eligibility criteria: Inclusion Criteria:

* ICD indication according to current national or international guidelines
* Patient available for follow-up during study period

Exclusion Criteria:

* Clinically unstable medical conditions that require regular outpatient clinic follow-up

Primary outcomes:
measure: Treatment satisfaction with ICD therapy and follow-up
timeFrame: 12 months
Secondary outcomes:
measure: Number of healthcare consultations
timeFrame: 12 months
Other outcomes:
Locations:
city: München
country: Germany
facility: Deutsches Hezzentrum
state: Bavaria
Study officials:
affiliation: Deutsches Herzzentrum
name: Kolb Christof
role: PRINCIPAL_INVESTIGATOR
References: