louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01897285: A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
Official title: A Single Centre, Randomised, Comparative, Blinded Wear Test of Two Adhesives on the AQUACEL® Foam Adhesive Dressing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety and Performance of Dressing Adhesive on Healthy Volunteers
Keywords: Performance and safety of the AQUACEL® foam adhesive dressing
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
First posted: 2013-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: AQUACEL® foam adhesive dressing is a sterile Hydrofiber® foam wound dressing consisting of a waterproof outer polyurethane film, and a multi-layered absorbent pad, having a silicone adhesive border. The multi-layered absorbent pad contains a layer of polyurethane foam and a non-woven wound contact layer of Hydrofiber® (NaCMC). This dressing product was launched in 2012. A new source of silicone adhesive is now under assessment for this product. This Healthy Volunteer Wear test will form part of the Design Validation for this change in supplier and is required to confirm that the new Silicone Adhesive trilaminate supplier can coat the silicone adhesive to provide comparable adhesive dressing performance in terms of wear time, ease of use and with a similar safety profile in relation to the skin.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent
* Be a healthy volunteer and be over 18 years of age
* Be willing to attend two scheduled visits for application and removal of the device and adverse event review
* Have healthy unbroken skin

Exclusion Criteria:

* Subjects with a history of sensitivity to any one of the components of the device being studied
* Female subjects who are currently pregnant or lactating
* Subjects who are not willing and able to attend the 'clinic' for the required assessments
* Subjects with excessive hair on their backs
* Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study

Primary outcomes:
measure: Product Performance (Adhesion, Conformability, Ease of Application/Removal, Adhesive Residue, Comfort During Removal, Condition of the Skin)
timeFrame: 7 days
Secondary outcomes:
measure: Safety - the Nature and Frequency of Adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
city: Deeside
country: United Kingdom
facility: Global Development Centre, Deeside Industrial Park
state: Flintshire
Study officials:
affiliation: Wirral University Teaching Hospital NHS Trust
name: Gwen Lawrence, RGN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00281385: Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity
Official title: Health and Psychological Outcomes of Lifestyle Versus Traditional Physical Activity- Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sedentary Behaviour
Adherence
Traditional Exercise
Lifestyle Exercise
Keywords: adherence
lifestyle
exercise
pedometer
training
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2006-01-24
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a comparison of the traditional prescription versus the lifestyle exercise prescription in sedentary adults over 6 months. Biological and psychological parameters will be assessed over the 6 month study. Biological indicators will be assessed pre and post including body composition, muscular strength, endurance, and flexibility, aerobic fitness, and blood tests. Psychological parameters will be assessed pre, mid, and post including self-efficacy, motivation, need satisfaction, physical self-description, leisure-time exercise, as well as all constructs from the thepry of planned behaviour.


Eligibility criteria: Inclusion Criteria:

* 25-65 years old
* exercise less than twice per month in the preceeding 6 months
* physician consent to participate

Exclusion Criteria:

* health problems
* exercise more than twice per month in the preceeding 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Wendy M Rodgers, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Gordon J Bell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Kerry Courneya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Vicki J Harber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00417937: A Multicenter Trial of a Topical Medication for Papulopustular Rosacea Applied Twice Daily Versus Once Daily
Official title: A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Papulopustular Rosacea
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
Collaborators: name: Bayer
First posted: 2007-01-04
Enrollment: 98
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 assess the efficacy and tolerability of azelaic acid 15% gel applied once daily versus twice daily in the treatment of patients with papulopustular rosacea.

Detailed description: To test the efficacy and safety of once vs twice daily application of azelaic acid 15% gel on papulopustular rosacea

Eligibility criteria: Inclusion Criteria:

- Papulopustular facial rosacea; minimum of 10, maximum of 50 inflamed papules and/or pustules

Exclusion Criteria:

* Mild or severe rosacea
* Rosacea with marked ocular manifestations
* Presence of dermatoses that could interfere with the rosacea diagnosis or evaluation of the study course
* Wash out period required for patients treated prior to study with topical retinoids, oral antibiotics, topical antibiotics, systemic and topical corticosteroids, topical imidazole, laser surgery for telangiectasia
* History of hypersensitivity to propylene glycol

Primary outcomes:
measure: Investigator's global assessment scored on a seven point scale
timeFrame: Measurements made during the course of treatment
Secondary outcomes:
measure: Inflammatory lesion count, erythema, telangiectasia, patient self assessment, patient opinion about therapy
timeFrame: Parameters measured during the course of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Intendis GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04681937: Comparison of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
Official title: Clinical and Radiological Comparison of the Efficacy of Hyaluronic Acid, PRP and Steroid Injections in Partial Rotator Cuff Tears: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Partial Tear of Rotator Cuff
Rotator Cuff Tears
Keywords: partial rotator cuff tear
subacromial injection
plateled-rich-plasma
physical therapy
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are many conservative treatment options available for partial rotator cuff tears. However, the superiority of a certain type of injection could not be demonstrated with the available data. Our aim is to compare the effectiveness of steroid, hyaluronic acid, prp and placebo (normal saline) injections in partial rotator cuff tears by applying the same physical therapy protocol after injection.


Eligibility criteria: Inclusion Criteria:

* persistent continous pain at least 3 months
* partial thickness rotator cuff tear on MRI

Exclusion Criteria:

* inflammatory disease
* pregnancy
* known malignancy
* bleeding disorder ( or \<10 g/dl Hb level, \<150.000 ul platelet)
* previous shoulder injection
* history of shoulder surgery
* full-thickness tear
* other shoulder problem (osteoarthritis, bony lesions, etc)

Primary outcomes:
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES)
timeFrame: 12 months after injection
Secondary outcomes:
measure: Constant-Murley Shoulder Outcome Score (CMS)
timeFrame: 12 months after injection
measure: Visual analogue scale (VAS)
timeFrame: 12 months after injection
measure: Subjective Shoulder Value (SSV)
timeFrame: 12 months after injection
measure: Range of Motion (ROM)
timeFrame: 12 months after injection
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
References:
Clinical trial NCT04311437: Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy
Official title: Effect of Self-acupressure on Middle Ear Barotrauma Associated With Hyperbaric Oxygen Therapy: a Nonrandomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperbaric Oxygen Therapy
Middle Ear Barotrauma
Keywords: Hyperbaric oxygen therapy
Middle ear barotrauma
Acupressure
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 152
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: Middle ear barotrauma (MEB) is the most common complication during hyperbaric oxygen therapy (HBOT). Though Valsalva and Toynbee maneuvers have been proposed to prevent MEB, still some patients discontinue HBOT due to severe otalgia, hemorrhage or perforation of tympanic membrane associated with HBOT. Currently, there is no optimal prophylactic management for MEB associated with HBOT. The aim of this protocol is to investigate the efficacy of self-acupressure therapy on MEB associated with HBOT.


Eligibility criteria: Inclusion Criteria:

* Aged 20 years or order receiving the first HBOT
* Alert consciousness

Exclusion Criteria:

* Pregnancy
* Having any acute disorder of the ears or upper respiratory tract
* Having evidence of neurologic dysfunction precluding them from making an informed decision
* Having a tracheostomy or endotracheal intubation
* Having received a myringotomy, tympanoplasty, mastoidectomy or tympanostomy tube placement.

Primary outcomes:
measure: Modified Teed Classification
timeFrame: 1 month
Secondary outcomes:
measure: Symptoms of MEB
timeFrame: 1 month
measure: Overall ear discomfort levels
timeFrame: 1 month
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Department of Chinese Medicine, Kaohsiung Chang Gung Memorial Hospital
name: Chun-Ting Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen JM, Lu ZN, Wu RW, Bi KW, Liu CT. Effect of self-acupressure on middle ear barotrauma associated with hyperbaric oxygen therapy: A nonrandomized clinical trial. Medicine (Baltimore). 2021 Apr 30;100(17):e25674. doi: 10.1097/MD.0000000000025674.
Clinical trial NCT03771937: The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model
Official title: The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model After Myocardial Infarction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
Keywords: lifestyle change
telephone follow-up
Roy Adaptation Model
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 66
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this parallel randomized controlled trial (n = 33/group), the control group received routine care, while the intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the Roy Adaptation Model.

Detailed description: Objective: To evaluate the effect of education and telephone follow-up intervention based on the Roy Adaptation Model (RAM) for improving MI patients' self-efficacy, quality of life and lifestyle adaptation.

Methods: In this parallel randomized controlled trial (n = 33/group), the control group received routine care, while the intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the RAM. Data were collected before discharge, and in the 12th week after discharge included quality of life, coping adaptation process, self-efficacy and lifestyle changes.

Eligibility criteria: Inclusion Criteria:

1. Participants were adults aged ≥30 years and had been admitted to the hospital with a diagnosis of MI (which must be supported by ECG and an increase in biomarkers).
2. were clinically stable
3. willing to participate
4. able to understand and write Turkish
5. able to receive telephone calls or fill in questionnaires.
6. able to come to the hospital for checkups. Exclusion Criteria:Patients were excluded from the study if according to medical file records they had chronic renal failure, cancer, heart failure, severe aortic stenosis, if they were planned for surgical treatment or had chronic cognitive and psychiatric disease, if they had problems with hearing and speaking on the phone, or if they had mobility restriction.

Primary outcomes:
measure: General Self-Efficacy Scale
timeFrame: 12 week
measure: Coping and Adaptation scale
timeFrame: 12 week
measure: Myocardial Infarction Dimensional Assessment Scale
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Akdeniz University Nursing Faculty
name: Selma Turan Kavradım, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Akdeniz University Nursing Faculty
name: Zeynep Canlı ÖZER, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01485237: Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization
Official title: Severe Pandemic H1N1 Infection in ICU: Comparative Resource Utilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Novel H1N1 Influenzal Acute Respiratory Infection
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2011-12-05
Enrollment: 400
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: Patients with severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Patients with other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS)that may require some of the same treatments.

Brief summary: The main purpose of this study is to review the resource utilization of severe adult H1N1 pneumonia undergoing antiviral and oxygen therapy, mechanical ventilation and support with pulmonary rescue therapies ( nitric oxide, ECMO, HFO) in critically ill patients in Winnipeg. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). The investigators will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. The investigators will determine the resources used by both groups and compare. Finally the investigators will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.


Eligibility criteria: Inclusion Criteria:

1. \> 18years,
2. Suspected or confirmed influenza (Appendix A)
3. Requirement for ICU admission due to respiratory distress or critical illness defined as one of:a) Inspired oxygen need of \>50% for at least 4 hours (For FiO2 for non-intubated patients see Appendix B) b) mechanical ventilation c) Patient is receiving inotrope or vasopressor

Exclusion Criteria:

1. Age less than 18 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Centre, Winnipeg
state: Manitoba
Study officials:
affiliation: Health Sciences Centre, Winnipeg
name: Anand Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01496937: First-in-Human Exploratory Single Ascending Dose of GLPG0974
Official title: Exploratory Double-blind Placebo-controlled Study for the Assessment of Pharmacokinetics (PK), Safety, Tolerability, and Pharmacodynamics (PD) of Single Ascending Oral Doses of GLPG0974 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2011-12-21
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this exploratory first-in-human study is to evaluate the amount of GLPG0974 present in the blood (pharmacokinetics) after single oral doses of GLPG0974 given to healthy subjects.

Furthermore, during the course of the study, safety and tolerability as well as the effects of GLPG0974 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized compared to placebo.


Eligibility criteria: Inclusion Criteria:

* Healthy male, age 18-50 years
* BMI between 18-30 kg/m2

Exclusion Criteria:

* Any condition that might interfere with the procedures or tests in this study
* Drug or alcohol abuse
* Smoking

Primary outcomes:
measure: The amount of GLPG0974 in plasma over time after a single oral dose
Secondary outcomes:
measure: Safety and tolerability
measure: Inhibition of CD11b on neutrophils in blood after a single oral dose of GLPG0974
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Frédéric Vanhoutte, MD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Wouter Haazen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03901937: The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease
Official title: Department of General Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310016, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Crohn Disease
Keywords: postoperative complications
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 158
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: PREVENTION

Brief summary: This study is intended to investigate the safety and efficacy of ω-3 polyunsaturated fatty acid-based parenteral nutrition (PN) for patients with Crohn's disease.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis as Crohn's disease according to definition;
2. Bowel resection;
3. With parenteral nutrition at least 5 days
4. 18 years old\<age\<75 years old;
5. Sign the informed consent.

Exclusion Criteria:

1. Emergency surgery;
2. With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction;
3. Incomplete laboratory data;
4. With parenteral nutrition before surgery;
5. Pregnant;
6. Allergy of ω-3 polyunsaturated fatty acid.

Primary outcomes:
measure: Rate of Postoperative complications
timeFrame: postoperative 1-30 days
Secondary outcomes:
measure: Length of postoperative hospital stay
timeFrame: from surgery to discharge
measure: Blood Concentration of IL-6
timeFrame: postoperative 1, 3, and 6 day
measure: Blood Concentration of TNF-α
timeFrame: postoperative 1, 3, and 6 day
measure: Blood Concentration of IL-1β
timeFrame: postoperative 1, 3, and 6 day
measure: Blood Concentration of albumin
timeFrame: postoperative 1, 3, and 6 day
measure: Blood Concentration of C-reactive protein
timeFrame: postoperative 1, 3, and 6 day
measure: Blood White blood cell level
timeFrame: postoperative 1, 3, and 6 day
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw hospital
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Xiujun Cai
role: STUDY_CHAIR
References: