louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02124356: Functional Performance Following Emergency High-risk Abdominal Surgery
Official title: Functional Performance Following Emergency High-risk Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency High-risk Abdominal Surgery
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 50
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients (19 years and older) undergoing Emergency High-risk Abdominal Surgery at the Hvidovre University Hospital.

Brief summary: Emergency abdominal surgery is associated with high mortality rates, multiple postoperative complications and prolonged duration of hospital admission. The purpose of this study is to examine the postoperative functional performance in patients undergoing Emergency High-risk Abdominal Surgery. The hypothesis is that the study can describe the patient population in relation to postoperative functioning, degree of inactivity and the factors that limit mobility.


Eligibility criteria: Inclusion Criteria:

* Patients (19 years and older) undergoing emergency laparotomy or laparoscopy (inclusive reoperations after elective surgery).

Exclusion Criteria:

* Patients undergoing minor emergency operations (uncomplicated appendectomy, laparoscopic cholecystectomy, diagnostic laparoscopy or laparotomy without intervention)

Primary outcomes:
measure: Basic mobility evaluated by the Cumulated Ambulation Score (CAS)
timeFrame: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
Secondary outcomes:
measure: Physical activity assessment with accelerometer (ActivePAL)
timeFrame: Daily on postoperative day 1 to 7.
measure: Visual Analog Scale (VAS)
timeFrame: Daily on postoperative day 1 to 7 and at discharge from the hospital (average length of stay is: 14 days).
measure: Assessment of Motor and Process Skills (AMPS)
timeFrame: One time at postoperative day 4.
Other outcomes:
measure: New Mobility Score (NMS)
timeFrame: At inclusion/baseline
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
References:
Clinical trial NCT00620256: Adjunctive Study of AL-37807 Ophthalmic Suspension
Official title: Comparison of Safety and Efficacy of Al-37807 Ophthalmic Suspension vs. Timolol Gel Forming Solution and Vehicle, All Dosed Concomitantly With Xalatan in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the safety and intraocular pressure-lowering efficacy of AL-37807 ophthalmic suspension vs. Timolol gel forming solution vs. AL-37807 vehicle, all dosed concomitantly with Xalatan, in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Open-angle glaucoma
* Ocular hypertension
* Must have been on Xalatan for at least 3 months
* VA not worse than 0.60
* Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

* Age related
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Mean change from baseline in intraocular pressure
timeFrame: Baseline, up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center at 1-888-451-3937
state: Texas
Study officials:
References:
Clinical trial NCT05027256: Entia Liberty: Usability Validation
Official title: Entia Liberty: Usability Validation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Lead sponsor: Entia Ltd
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited from the outpatients clinic at the Christie

Brief summary: This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's validation of the device. Participants will be trained to take an Entia Liberty test in a simulated home environment and a trained healthcare professional will perform another test from the same participant (different finger) on a separate device. The results will be compared. Usability data will be observed and the participants will complete a questionnaire after the tests have been performed.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old at the time of study entry
* Can provide written informed consent
* Patients who are currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and have received at least one cycle
* Sufficient hearing to be able to participate in a video training session

Exclusion Criteria:

* Known inherited or acquired bleeding disorder
* History of haematological malignancy
* Known poorly controlled anti-coagulation
* Inadequate use and understanding of the English language, requiring a translator
* Participant unlikely to be able to perform fine manipulation required to use lancet or cartridge to obtain capillary blood sample and result
* Previously taken part in the 'PERTH-2' study involving a prototype device

Primary outcomes:
measure: Number of participants able to use the Entia Liberty device as specified in the validation procedure is 80%.
timeFrame: 3 months
measure: Number of participants with new severe usability problems identified.
timeFrame: 3 months
measure: Number of participants with study-related adverse events as assessed by the Residual Risk analysis of the usability data using predefined criteria for severity and occurrence in accordance with ISO 14971:2019(E)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aylesbury
country: United Kingdom
facility: Buckinghamshire Healthcare NHS Trust
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
References:
Clinical trial NCT06038409: Ketamine Treatment Plans for Chronic Conditions
Official title: Understanding the Safety of Home Ketamine Treatment Plans for Chronic Conditions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Pain
Depressive Disorder
Anxiety Disorders
Chronic Disease
Lead sponsor: RIVER Foundation
Sponsor class: OTHER
First posted: 2023-09-14
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with chronic conditions that need either their mental health or pain controlled.

Brief summary: A study aimed to assess the efficacy of the various approaches to prescribing Ketamine currently in use off-label. The focus will be to include ketamine within the study plan of those with chronic conditions who are receiving ketamine.

Detailed description: Ketamine can be administered in multiple ways (IV, IM, SubQ, and Sublingual, among others), and there have been few if any, studies that have compared the impact of Ketamine at home without any thearpy.

The study will identify other treatment modalities used in concurrence with Ketamine. Psychotherapy, music therapy, and acutherapy are some of the most popular. How do these adjunct therapies affect the outcomes of Ketamine treatments?

Secondarily, the study will focus on these significant issues to observe the impact of Ketamine treatments and suicidal ideation. Suicidal ideation is multifaceted and is one reason for prescribing off-label Ketamine. Chronic issues such as depression, pain, and anxiety have been identified as underlying causes and may be improvable with Ketamine.

Eligibility criteria: Inclusion Criteria:

Must have an identifiable chronic condition.

Exclusion Criteria:

Healthy population

Primary outcomes:
measure: Ketamine route of use acceptability.
timeFrame: through study completion, an average of 1 year
measure: Mental Health PHQ9
timeFrame: through study completion, an average of 1 year
measure: Mental Health GAD7
timeFrame: through study completion, an average of 1 year
measure: Mental Health PCL5
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Helena
country: United States
facility: RIVER Telehealth
state: Montana
Study officials:
affiliation: RIVER Foundation
name: Edward Lesofski, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06555185: Acute Responses to a Potentiation Warm-up Protocol in Female Football Players.
Official title: Acute Responses to a Potentiation Warm-up Protocol on Sprint and Change of Direction in Female Football Players: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Athletic Performance
Keywords: performance enhancement
warm-up
sprint
change of direction
women's football
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: Universidade do Porto
First posted: 2024-08-15
Enrollment: 17
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to determine if the performance of female football players is affected after exposure to a potentiation protocol. It is hypothesized that performance in the selected physical tests will improve significantly and meaningfully after performing the chosen potentiation protocol compared to the control group's warm-up.


Eligibility criteria: Inclusion Criteria:

* players from any playing position (except goalkeepers) able to train without limitations.

Exclusion Criteria:

* players with any existing medical conditions that could compromise participation.

Primary outcomes:
measure: Agility T-test
timeFrame: First moment: beginning of the first training session; Second moment: at the end of the third week, after the fourth protocol session had been completed.
measure: 40-m sprint test
timeFrame: First moment: beginning of the first training session; Second moment: at the end of the third week, after the fourth protocol session had been completed.
Secondary outcomes:
Other outcomes:
Locations:
city: Famalicao
country: Portugal
facility: Futebol Clube de Famalicão
Study officials:
affiliation: Faculty of Science and Technology, UiT The Arctic University of Norway
name: Ivan Baptista, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02427685: Dysfunctional Hemoglobin CO-ox
Official title: Dysfunctional Hemoglobin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elevated Levels of Carboxyhemoglobin
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2015-04-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers

Brief summary: The study verifies accuracy of a new pulse co-oximeter in the presence of elevated carboxyhemoglobin levels.


Eligibility criteria: Inclusion Criteria:

* The subject is male or female.
* The subject is of any racial or ethnic group.
* The subject is between 18 years and 45 years of age.
* The subject does not have significant medical problems.
* The subject is willing to provide written informed consent and is willing and able to comply with study procedures.

Exclusion Criteria:

* Has a BMI greater than 31
* Has had any relevant injury at the sensor location site
* Has deformities or abnormalities that may prevent proper application of the device under test.
* Has a known respiratory condition.
* Is currently a smoker.
* Has a known heart or cardiovascular condition.
* Is currently pregnant.
* Is female and actively trying to get pregnant.
* Has a clotting disorder.
* Has Raynaud's Disease.
* Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia).
* The subject has a COHb greater than 3% or MetHb greater than 2%.
* Has taken blood thinners or medication with aspirin within the last 24 hours.
* Has unacceptable collateral circulation from the ulnar artery.
* Has donated more than 300 mL of blood within one month prior to start of study.
* Is unwilling or unable to provide written informed consent to participate in the study.
* Is unwilling or unable to comply with the study procedures for the primary objectives.
* Has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Primary outcomes:
measure: Carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry.
timeFrame: 3 hours
Secondary outcomes:
measure: Oxygen saturation accuracy in conditions of elevated carboxyhemoglobin.
timeFrame: 3 hours
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Phillip E Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02881385: Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation
Official title: Effects on Respiratory Patterns and Patient-ventilator Synchrony in Different Ventilator Using Pressure Support Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Respiratory Distress Syndrome
COPD
Post Operative
Keywords: Synchrony
Pressure Support Ventilation
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2016-08-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: mechanical ventilation adult people using PSV mode in ICU

Brief summary: Pressure Support Ventilation use Expiratory triggering sensitivity(Esense) to transfer inspiration to expiration,the value of Esense is fixed.That may lead to asynchrony between humans and ventilators,making people uncomfortable and prolonging weaning time.Some ventilators have auto cycle function Based on curves of pressure on respiratory patterns,it will make the transforming more synchrony with humans.Our prospective observational study will prove the superiority of the auto cycle function.

Detailed description: From August 31st 2016 to August 31st 2017, all ARDS 、COPD and postoperative patients admitted to the ICUs will be enrolled. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, weaning outcome and 28 day mortality will be recorded

Eligibility criteria: Inclusion Criteria:

ARDS,COPD and Postoperative patient

Exclusion Criteria:

variety of reasons can not be placed next to the bed by the nasal EAdi catheter

Primary outcomes:
measure: patient-ventilator synchrony using PSV mode between different ventilator for 180mins
timeFrame: 180mins after the patients involved
Secondary outcomes:
measure: Patient Respiratory Patterns during Pressure Support Ventilation for 180mins
timeFrame: 180mins
measure: Patient gas exchange during Pressure Support Ventilation for 180mins
timeFrame: 180mins
measure: Effects on Respiratory Patterns in different Expiratory triggering sensitivity for 180mins
timeFrame: 180mins
measure: work of triggering and respiratory in different Expiratory triggering sensitivity for 180mins
timeFrame: 180mins
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06161285: Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
Official title: Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bronchiolitis
Keywords: Newborns
Dysbiosis
respiratory syncytial virus (RSV)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Infectious Diseases Models for Innovative Therapies center
First posted: 2023-12-07
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Bronchiolitis in patient under 12 months old

Brief summary: Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.


Eligibility criteria: Inclusion Criteria:

* Infants \<12 months
* With bronchiolitis during RSV epidemic season
* No chronic illness
* No bronchiolitis medical history
* Signed consent from parents or legal guardians

Exclusion Criteria:

* Chronic respiratory illness
* Medical history of bronchiolitis or newborn asthma
* Treatment with immunosuppressants
* Patient with no social security affiliation

Primary outcomes:
measure: Dysbiosis
timeFrame: Inclusion
Secondary outcomes:
measure: Measurement of innate and adaptive responses by quantification of cytokines and chemokines in plasma
timeFrame: inclusion
measure: Identifying the mRNA profile in blood samples and nasal swabs
timeFrame: inclusion
measure: Sequencing viral strains for mutation
timeFrame: Inclusion
measure: Comparison of respiratory syncytial virus (RSV) antibodies levels on newborn screening specimen and on capillary swab during infection
timeFrame: Birth, Inclusion
measure: Study the load of Streptococcus pneumoniae (Sp) in RSV infections.
timeFrame: Inclusion
Other outcomes:
Locations:
city: Clamart
country: France
facility: APHP, Antoine Béclère Hospital
city: Garches
country: France
facility: AP-HP,Raymond Poincaré Hospital
city: Paris
country: France
facility: Réanimation médico-chirurgicale Necker
Study officials:
affiliation: AP-HP Hôpital Antoine Beclere
name: Etienne BIZOT, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01637285: A Pharmacokinetic Study of CVX-096 (PF-04856883) in Healthy Volunteers
Official title: A Phase 1, Randomized, Open-label, Parallel-group Study To Evaluate The Pharmacokinetics Of Pf-04856883 (Cvx-096) Following Subcutaneous Administration In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-07-11
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to further evaluate the PK characteristics of PF-04856883.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: PF-04856883 Pharmacokinetics including Cmax, Tmax, AUCo-infinity, AUClast, Cl/F, Vz/F and t1/2
timeFrame: 4 weeks
Secondary outcomes:
measure: Number of subjects with AEs reported
timeFrame: 4 weeks
measure: Number of subjects with abnormal physical examination findings
timeFrame: 4 weeks
measure: Number of subjects with abnormal clinical laboratory results
timeFrame: 4 weeks
measure: Number of subjects with abnormal ECGs
timeFrame: 4 weeks
measure: Number of subjects with abnormal vital signs
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01348685: Comparing Liquid Versus Solid Forms of Sugars and Whey Protein
Official title: Effect of Drinking Liquid Compared to Eating Solid Treatment of Sugars or Whey Protein on Short-term Appetite and Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Obesity
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Mondelēz International, Inc.
name: Canadian Sugar Institute
First posted: 2011-05-05
Enrollment: 43
Sex: MALE
Minimum age (years): 19
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: To compare the effect of eating solid vs. drinking liquid forms of gelatin, sucrose and its component mixtures and whey protein on subjective appetite and food intake in young men.

Detailed description: Three randomized cross-over design experiments were used to compare the effect of solid and liquid forms of gelatin (6 g) in experiment 1, sucrose (75 g) and a mixture of 50% glucose/ 50% fructose (G50:F50) in experiment 2, and acid and sweet whey protein (50 g) in experiment 3 on healthy normal weight males . The controls were water (experiment 1 and 3) and calorie-free sweetened water with gelatin (sweet gelatin, experiment 1) or without gelatin (sweet control, experiment 2). Subjective average appetite was measured by visual analogue scales frequently over 1 h and ad libitum food intake was measured 1 h after the treatment consumptions.

Eligibility criteria: Inclusion Criteria:

* Healthy lean males with BMI between 18- 24.9 kg/m2 and an age range of 19 to 28 years were recruited for the three experiments.

Exclusion Criteria:

* Diabetics (fasting blood glucose ≥ 7.0 mmol/L), smokers, breakfast skippers or dieters were excluded from the experiments. Individuals under medications or with a history of liver or kidney disease and major medical or surgical event within the last six months were excluded.

Primary outcomes:
measure: subjective appetite and short term food intake
timeFrame: 60 min
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto, Department of Nutritional Sciences
state: Ontario
Study officials:
References: