louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02268981: Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
Official title: Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Oxymizer
Oxygen conserving device
Conventional nasal cannula (CNC)
Idiopathic pulmonary fibrosis
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
First posted: 2014-10-20
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.

Detailed description: Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program. They will perform the following three interventions on consecutive days and will repeat them after a week. During these days the time table for prescribed physical activities and therapies will be kept in a comparable fashion.

The following 3 interventions will be performed in randomized order:

Day A: The Patient wears a conventional nasal cannula for 12 h with oxygen flow rate as prescribed during ADL

Day B: The Patient wears the Oxymizer® with prescribed oxygen flow rate for 12 h during ADL

Day C: The patient wears the Oxymizer® with a flow rate reduced by 1l/min in comparison to the prescribed oxygen flow rate, for 12h

The following week the same measurements will be repeated. The mean of the corresponding two measures will be calculated for each approach.

Eligibility criteria: Inclusion Criteria:

* IPF patients with indication for long term oxygen therapy ≥ 2l/min
* VC \>30% and \< 70% pred.

Exclusion Criteria:

* failure to comply with study process
* acute infection

Primary outcomes:
measure: Difference in oxygen saturation between Oxymizer and conventional nasal cannula
timeFrame: day 1 to 13
Secondary outcomes:
Other outcomes:
Locations:
city: Schoenau am Koenigssee
country: Germany
facility: Klinikum Berchtesgadener Land der Schön-Kliniken
state: Bayern
Study officials:
affiliation: Schoen Klinik BGL
name: Klaus Kenn, Dr. med
role: STUDY_CHAIR
References:
Clinical trial NCT04722081: Virtual Reality for Tibial Eminence Fractures
Official title: Virtual Reality Training Combined With a Physical Therapy Program in the Rehabilitation of Patients After Tibial Eminence Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tibial Fractures
Keywords: Tibial eminence fracture
Virtual reality
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tibial eminence fracture, a bony avulsion of the anterior cruciate ligament (ACL) from its insertion on the intercondylar eminence,1 was first described by Poncet in 1875. 2 Also known as tibial spine fractures, these injuries occur most commonly in skeletally immature patients between the ages of 8 and 14 years


Eligibility criteria: Inclusion Criteria:

* age of children from five to nine
* children have fracture in tibial eminence

Exclusion Criteria:

* children have fracture in tibial eminence grade III

Primary outcomes:
measure: Visual analogue scale
timeFrame: pain assessment at day 0
measure: Visual analogue scale
timeFrame: pain assessment at day 180
Secondary outcomes:
measure: A universal goniometer
timeFrame: assessment te range of knee extension at date 0
measure: A universal goniometer
timeFrame: assessment te range of knee extension at date 180
Other outcomes:
measure: Pediatric Balance Scale
timeFrame: assessment of balance at date 0
measure: Pediatric Balance Scale
timeFrame: assessment of balance at date 180
Locations:
city: Qina,
country: Egypt
facility: South Valley University, Faculty of Physical Therapy
Study officials:
affiliation: South Valley University, Faculty of Physical Therapy
name: Nehad A Abo-zaid, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young W, Ferguson S, Brault S, Craig C. Assessing and training standing balance in older adults: a novel approach using the 'Nintendo Wii' Balance Board. Gait Posture. 2011 Feb;33(2):303-5. doi: 10.1016/j.gaitpost.2010.10.089. Epub 2010 Nov 18.
citation: Wilfinger C, Castellani C, Raith J, Pilhatsch A, Hollwarth ME, Weinberg AM. Nonoperative treatment of tibial spine fractures in children-38 patients with a minimum follow-up of 1 year. J Orthop Trauma. 2009 Aug;23(7):519-24. doi: 10.1097/BOT.0b013e3181a13fe4.
citation: Vander Have KL, Ganley TJ, Kocher MS, Price CT, Herrera-Soto JA. Arthrofibrosis after surgical fixation of tibial eminence fractures in children and adolescents. Am J Sports Med. 2010 Feb;38(2):298-301. doi: 10.1177/0363546509348001. Epub 2009 Dec 23.
Clinical trial NCT01339481: A Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
Official title: A Phase 0, Open-Label, Multi-Center, Observational Study to Assess the Receptor Occupancy of CD86 and CD80 in Subjects With Rheumatoid Arthritis Initiating Abatacept
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Orencia
Abatacept
Rheumatoid Arthritis
Infusion
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Perseid Therapeutics LLC
First posted: 2011-04-20
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects with Rheumatoid Arthritis

Brief summary: The purpose of this study is to characterize CD86 receptor occupancy in subjects with rheumatoid arthritis (RA) receiving abatacept.


Eligibility criteria: Inclusion Criteria:

* Subject has rheumatoid arthritis (RA), is both abatacept- and belatacept-naïve, and is an eligible candidate to start a course of treatment with abatacept in accordance with the product label
* Subject is willing and able to comply with study visits and procedures

Primary outcomes:
measure: CD86 Receptor Occupancy
timeFrame: Day 1, Weeks 2, 4, 8, and 12
Secondary outcomes:
measure: CD80 Receptor Occupancy
timeFrame: Day 1, Weeks 2, 4, 8, and 12
measure: Abatacept serum concentration
timeFrame: Day 1, Weeks 2, 4, 8 and 12
measure: Change from Day 1 to Week 12 in Subject's Global Assessment of Arthritis
timeFrame: Day 1 and Week 12
measure: Change from Day 1 to Week 12 in Physician's Global Assessment of Arthritis
timeFrame: Day 1 and Week 12
measure: Safety assessed by adverse event reporting including Physical Examination findings
timeFrame: Day 1 through Week 12 post-infusion
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Palm Harbor
country: United States
facility: Arthritis Research of Florida
state: Florida
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
city: Lake Success
country: United States
facility: North Shore - Long Island Jewish Health System
state: New York
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: North Charleston
country: United States
facility: Low County Rheumatology
state: South Carolina
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
affiliation: Metroplex Clinical Research Center
name: Principal Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02605681: Midkine and ACE-Ang II Induced Endothelial Injury in Sepsis
Official title: Plasma Midkine Associated Organ Dysfunction and Vascular Injury in Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: midkine
endothelial injury
sepsis
angiotensin-converting enzyme
angiotensin II
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2015-11-16
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who diagnosed for sepsis

Brief summary: Plasma midkine has reported to be elevated in infection and a regulator of angiotensin-converting enzyme (ACE). We aimed to investigate the plasma midkine in septic patients and its association with 28-day mortality and organ function, and also with plasma ACE and angiotensin II.

Detailed description: This study showed that Ang II induced endothelial injury in sepsis patients. Midkine has been shown to regulate the renin-angiotensin system and acts in the upstream signaling pathway of angiotensin (ANG) II. The investigators want to access the relationship between midkine level and ACE-Ang II induced endothelial injury in sepsis

Eligibility criteria: The inclusive criteria were adult patients (age \> 18 years-old and \< 80 years-old) diagnosed with sepsis, according the definition of the Surviving Sepsis Campaign (2016)

Exclusive criteria included: 1. age \< 18 years-old or \> 80 years-old; 2. pregnancy or breastfeeding; 3. malignancy; 4. patients with potentially elevated plasma midkine apart from sepsis including acute myocardial infarction, stroke, limb thrombosis, chronic renal dysfunction (baseline plasma creatine ≥2 mg/dL), autoimmune diseases and Alzheimer syndrome; 5. patients deceased or discharge from ICU within 24 hours; or, 6. written consents could not be obtained.

Primary outcomes:
measure: 28-day mortality
timeFrame: up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Department of Critical Care Medicine
state: Jiangsu
Study officials:
References:
citation: Xu JY, Chang W, Sun Q, Peng F, Yang Y. Pulmonary midkine inhibition ameliorates sepsis induced lung injury. J Transl Med. 2021 Feb 27;19(1):91. doi: 10.1186/s12967-021-02755-z.
Clinical trial NCT03566381: Sweat Sensors for Athletic Performance
Official title: Pilot Study of a Wearable Sweat Sensor for Hydration Monitoring of Athletes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Adults
Keywords: Wearable sensor, sweat sensor
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2018-06-25
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: Pilot study of a soft, flexible wearable sweat sensor

Detailed description: Assessment of safety, and preliminary accuracy of a sweat sensor capable of operating underwater.

Eligibility criteria: Inclusion Criteria:

* No history of medical or surgical problems
* Age \>18 years old
* Subjects willing and able to comply with requirements of the protocol

Exclusion Criteria:

* Age \<18 years old
* Subjects unwilling and able to comply with requirements of the protocol
* History of skin allergy to medical adhesive tape

Primary outcomes:
measure: Adhesion of device underwater
timeFrame: 2 hours
Secondary outcomes:
measure: Correlation between local and global sweat loss
timeFrame: 2 hours
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shuai Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190681: Motivation and Methylphenidate
Official title: Etude Comparative Monocentrique, Randomisée, En Cross-over, En Double Aveugle, Contre Placebo, De L'action Du Méthylphénidate Sur Les Paramètres Cognitifs De La Motivation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Motivation
Apathy
Impulsive Behavior
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2017-06-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the impact of methylphenidate, a mixed dopaminergic and noradrenergic agent, onto the different components of motivation: decision-making, effort allocation and instrumental learning.


Eligibility criteria: Inclusion Criteria:

* weight\>= 50kg and \<=90kg
* free and informed consent
* social security affiliation
* no chronic illness
* no previous participation to a protocol wth similar tasks
* no special legal status (guardianship,trusteeship)
* no personnal or familial neurologic or psychiatric background
* no contraceptive device for a reproductive woman

Exclusion Criteria:

* inability to squeeze a handgrip
* smoking
* psychoactive substance consumption less than 3 weeks ago
* pregnant or breastfeeding woman
* hypersensitivity to methylphenidate
* hyperthyroidism
* cardiovascular or cerebrovascular disease
* respiratory, hepatic or renal failure
* glaucoma
* pheochromocytoma
* gluten intolerance or hypersensitivity
* galactosemia, glucose malabsorption syndrome, lactase deficit
* countraindicated meds (IMAO, IMAO-A, orhtosympathomimetics, alcaloids, linezolin, enzymatic inducers, psycho-active drugs)

Primary outcomes:
measure: coefficient of sensitivity to reward
timeFrame: two hours after administration
Secondary outcomes:
measure: coefficient of sensitivity to effort
timeFrame: two hours after administration
measure: coefficient of sensitivity to punishment
timeFrame: two hours after administration
measure: coefficient of sensitivity to delay
timeFrame: two hours after administration
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'investigation clinique, Institut du Cerveau et de la Moelle
Study officials:
References:
Clinical trial NCT03328481: Quadratus Lumborum Block Using Loss-of-resistance Versus Ultrasound-guided Technique
Official title: Quadratus Lumborum Block Using Loss-of-resistance Versus Ultrasound-guided Technique
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Abdominal Surgery
Quadratus Lumborum Block
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-11-01
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to explore the feasibility of using loss-of-resistance technique for Quadratus Lumborum block (QLB). And to compare between the Ultrasound guided QLB type II and the loss-of-resistance technique for QLB as regards the degree and duration of analgesia and side effects.

Detailed description: Quadratus lumborum block (QLB) is an abdominal plane block with increasing popularity. QLB is achieved by local anesthetic infiltration at the anterolateral aspect of quadratus lumborum muscle (QLB-I), or at the posterior aspect of the muscle (QLB-II), or transmuscular (QL-TM block). Ultrasound-guided technique is the usual route used for QLB performance. QLB had been considered a modification of transversus abdominis plane (TAP) block\[4\]. A cadaveric study had showed similar local anesthetic spread in both QL and TAP blocks.

TAP block could be performed by using either the ultrasound or loss-of-resistance technique; whilst, QLB is only performed using the ultrasound and the feasibility of loss-of-resistance technique had not been investigated for this block.

This study aims to explore the feasibility of using loss-of-resistance technique for QLB. And to compare between the Ultrasound guided QLB type II and the loss-of-resistance technique for QLB as regards the degree and duration of analgesia and side effects.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for lower abdominal surgery under general anesthesia

Exclusion Criteria:

* Patient refusal to regional block,
* Pregnancy
* Coagulopathy
* Cognitive impairment
* Inflammation or infection at the puncture site
* History of allergic reaction to study medications

Primary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Postoperative morphine consumption
timeFrame: 24 hours
measure: Intraoperative extra-analgesia requirements
timeFrame: 3 hours
measure: visual analogue pain score at rest to assess the pain severity
timeFrame: 24 hours
measure: Visual analogue pain score at movement to assess the pain severity
timeFrame: 24 hours
measure: Systolic blood pressure
timeFrame: 24 hours
measure: Heart rate
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed M Mukhtar
role: STUDY_DIRECTOR
References:
Clinical trial NCT01795781: Assays for and Reversal of New Anticoagulants
Official title: Development of Anticoagulant Assays for New Anticoagulants and Their Reversibility in Vitro
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Osteoarthritis of the Knee
Osteoarthritis of the Hip
Keywords: Anticoagulant measurement
Anticoagulant reversal
Dabigatran
Rivaroxaban
Lead sponsor: Royal Perth Hospital
Sponsor class: OTHER
First posted: 2013-02-21
Enrollment: 30
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: Patients with atrial fibrillation receiving dabigatran for thrombosis prevention or patients with osteoarthritis of the hip or knee receiving rivaroxaban after total hip or knee replacement respectively for thrombosis prevention

Brief summary: New anticoagulants are being introduced to replace warfarin. These drugs do not require monitoring and are safer. There is currently no recommended way to reverse these drugs rapidly in the event of undue bleeding or need for emergency surgery. This is a lab study to look at ways to reverse the drugs rapidly

Detailed description: We are developing in vitro assays of measurement of the effect of these drugs on the relevant coagulation pathways in plasma; such assays are not widely established. This will then allow us to test potential reversing agents such as activated Factor VII (Novo-Seven®), or Factor VIII inhibitor bypassing agent (FEIBA) for their ability to reverse these anti-coagulants invitro. The aims of this reversal research strategy is to provide a means whereby patients who present with serious bleeding or who need rapid reversal for surgery, for example, can be offered such treatment to allow rapid normalisation of their coagulation system.

As part of this developmental programme, we wish to obtain samples from patients receiving Rivaroxaban or Dabigatran for therapeutic reasons, to test the effect of the respective drug on the relevant coagulation factors and to test in vitro reversibility.

The only requirement for the patient is to have an extra 20ml of blood taken at a time when the patient is having other blood tests. There are no risks or experimental procedures planned to be carried out on patients.

Eligibility criteria: Inclusion Criteria:

* Receiving dabigatran for atrial fibrillation
* Or,for osteoarthritis of the hip or knee receiving rivaroxaban to prevent thromboembolic disease after total hip or knee replacement respectively

Exclusion Criteria:

* Failure to sign informed consent

Primary outcomes:
measure: Ability to reverse anticoagulant effect in vitro of dabigatran or rivarovaban
timeFrame: Two hours after ingestion of anticoagulant dose
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: Royal Perth Hospital, Wellington St, Perth, Australia
name: Ross I Baker, MB, BS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06387381: 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
Official title: 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: PSMA
FAP
Positron-Emission Tomography
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: As a new dual receptor (PSMA and FAP) targeting PET radiotracer, 68Ga-PSFA is promising as an excellent imaging agent applicable to PSMA/FAP positive diseases. In this research, we investigate the safety, biodistribution and potential usefulness of 68Ga-PSFA positron emission tomography (PET) for the diagnosis of lesions in PSMA/FAP positive diseases.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously malignant disease, with either PSMA or FAP positive expression (supporting evidence may include MRI, CT, and pathology report, etc).

Exclusion Criteria:

1. Patients with non-malignant disease.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to 68Ga-PSFA or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT01105910: Efficacy of Systane Ultra in Post Menopausal Women With Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Menopausal Dry Eye Subjects
Keywords: Dry Eye, Post Menopausal dry eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 70
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: To evaluate the efficacy of Systane Ultra in post menopausal women with dry eye.


Eligibility criteria: Inclusion Criteria:

1. Post-menopausal (menses ceased more than 12 months prior to the start of the study).
2. Diagnosed for dry eye

Exclusion Criteria:

1. History of Sjögren's Syndrome or evidence of chronic dry eye syndrome. Confirmed autoimmune connective tissue diseases such as rheumatoid arthritis, fibromyalgia or scleroderma.
2. Active and severe blepharitis, rosacea and associated ocular sequelae.
3. Has any significant eyelid abnormality affecting lid function.

Primary outcomes:
measure: Reduction in corneal staining
timeFrame: 30 days
Secondary outcomes:
measure: Patient acceptability / comfort
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References:
citation: http://www.aaopt.org/efficacy-evaluation-systane-ultra-lubricant-eye-drops-postmenopausal-women-dry-eye