louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02858882: Vitamin D Status and Muscle Function
Official title: Vitamin D Status and Muscle Function Among Adolescent and Young Swimmers.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Status
Muscle Function
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Team Denmark
name: Hvidovre University Hospital
name: Danmarks Fødevareforskning
name: Bispebjerg Hospital
First posted: 2016-08-08
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE

Brief summary: People living at Northern latitudes are at risk of suffering from vitamin D insufficiency due to low sun exposure and the risk may be even more pronounced among elite swimmers since indoor training further reduces sun exposure. In light of this, the investigators want to examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength.

Detailed description: To examine vitamin D status in young elite swimmers and if there is an association between vitamin D status and muscle strength, twenty-nine swimmers, 12 female and 17 male (16-24 years) residing at latitude 55-56°N were included to the trial conducted in March-April. Blood samples were analysed for serum 25-hydroxyvitamin D (s-25(OH)D) and hand-grip strength was measured as marker of muscle strength. Subjects´ vitamin D and calcium intake were assessed by food frequency questionnaire and sun exposure and training status by questionnaires.

Eligibility criteria: Inclusion Criteria:

Age: 16-35 years

Top atlets, conducting:

* Hard physical activity
* Indoor elitesport min. 10 hours a week
* Healthy, without use of any medications
* Eat fish max 2 times per week

Exclusion Criteria:

* Use of corticosteroids
* Illness
* Use of supplements
* Use of solarium
* Donation of blood within the last 3 months
* Having spent time below the latitude of 42° north from September through April

Primary outcomes:
measure: Serum 25-hydroxyvitamin D (s-25(OH)D)
timeFrame: 2 months
Secondary outcomes:
measure: Food frequency questionnaire
timeFrame: One week
measure: Hand-grip strength
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01470482: Does Tourniquet Use in Total Knee Replacement Improve Fixation
Official title: Does Tourniquet Use in Total Knee Replacement Improve Fixation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Total knee
Tourniquet
Blood loss
pain
range of motion
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2011-11-11
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.

Detailed description: The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.

We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.

Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.

Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years

Eligibility criteria: Inclusion Criteria:

* primary or secondary osteoarthritis without other severe disease (ASA 1-2).

Exclusion Criteria:

* were inability to give informed consent,
* rheumatic arthritis,
* malignancy,
* coagulation disorder or medical treatment influencing the coagulation,
* liver disease,
* severe heart disease or bilateral operation.

Primary outcomes:
measure: View protocol record
timeFrame: 2 years
Secondary outcomes:
measure: View Protocol Record
timeFrame: 2 years
Other outcomes:
Locations:
city: Motala
country: Sweden
facility: Motala hospital
Study officials:
affiliation: Linkoeping University
name: Per Aspenberg, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03326882: Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children
Official title: Comparison of Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children Aged >1 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesiology
Pediatrics
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.

Detailed description: This was a prospective randomized clinical study to be performed in pediatric patients older than 1 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation was compared between patients intubated using a GlideScope® video laryngoscope, and those intubated by standard direct laryngoscopy. The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II patients,
* scheduled for elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* risk of pulmonary aspiration,
* presence of difficult intubation,
* emergency surgery,
* cardiovascular disease,
* respiratuar disease,
* hemodynamic instability.

Primary outcomes:
measure: Duration of Intubation
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sisli Hamidiye Etfal Training and Research Hospital
name: Canan Tulay Isil
role: STUDY_DIRECTOR
References:
citation: Holm-Knudsen RJ, Rasmussen LS. Paediatric airway management: basic aspects. Acta Anaesthesiol Scand. 2009 Jan;53(1):1-9. doi: 10.1111/j.1399-6576.2008.01794.x.
Clinical trial NCT06158282: Effects of Walking Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Official title: Effects of Walking Apnea at High Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Pain
Hypoxia
Hypercapnia
Apnea
Lead sponsor: Centro Universitario La Salle
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent walking apneas training session at high lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention.


Eligibility criteria: Inclusion Criteria:

- Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.

Primary outcomes:
measure: Pain pressure threshold (PPT) on thumb, anterior tibial and spinous process of C7
timeFrame: before and after intervention (up 30 minutes)
Secondary outcomes:
measure: Perceived Stress Scale (PSS)
timeFrame: before intervention (up 5 minutes)
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: before intervention (up 5 minutes)
measure: Global Physical Activity Questionnaire (GPAQ)
timeFrame: before intervention (up 5 minutes)
measure: Heart rate
timeFrame: during intervention (up 6 minutes)
measure: Oxygen saturation
timeFrame: during intervention (up 6 minutes)
measure: Blood pressure
timeFrame: before, during and after intervention (up 10 minutes)
measure: Rate of perceived exertion (RPE)
timeFrame: immediately after intervention (up 10 seconds)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: CSEU LaSalle
Study officials:
References:
Clinical trial NCT04392882: Effects of Legumes Consumption on Weight Reduction
Official title: Effects of Legumes Consumption on Weight Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obese
Keywords: legumes
obesity
body weight
adiponectin
8-epi-PGF2α
insulin resistance
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a 12-week, randomized nutritional intervention study to determine the effect of legumes consumption on body weight in obese subjects.


Eligibility criteria: Inclusion Criteria:

1. Male and female volunteers between the ages of 20 to 70 years
2. Body mass index (BMI) of 25 kg/m2 or higher (based on Asia-Pacific guideline)
3. Volunteers who have agreed to participate in the study and provided a written content by him/herself

Exclusion Criteria:

1. Those with type 2 diabetes, cardiovascular disease, psychiatric problems, thyroid disorders, liver or kidney disease
2. Those under the use of any medications (antihypertensive, lipid-lowering, antiplatelet, antidiabetic, etc.).

Primary outcomes:
measure: Changes of BMI
timeFrame: 12 weeks
measure: Changes of Insulin Resistance (IR)
timeFrame: 12 weeks
measure: Changes of lipid profiles
timeFrame: 12 weeks
measure: Changes of serum high C-reactive
timeFrame: 12 weeks
measure: Changes of urinary 8-epi-PGF2α
timeFrame: 12 weeks
measure: Changes of adiponectin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05763082: Bioequivalence Study of Two Treatments for the Treatment of Plaque Psoriasis
Official title: Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis' Roflumilast Cream 0.3% to Arcutis's Zoryve™ (Roflumilast Cream 0.3%) Cream and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plaque Psoriasis
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 414
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety and efficacy of Padagis' product to an FDA approved product for the treatment of plaque psoriasis


Eligibility criteria: Inclusion Criteria:

1. Signed IRB approved written informed consent/assent
2. 12 to 75 years of age, inclusive.
3. Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.
4. Baseline Investigator's Global Assessment Score of 3 (moderate).
5. Subjects must have a Body Surface Area (BSA) between 2% to 20%
6. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.

Exclusion Criteria:

1. Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
2. Current diagnosis of unstable forms of psoriasis in the treatment area.
3. History of unresponsiveness to topical treatment for psoriasis
4. Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations
5. Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
6. Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study
7. Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
8. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study

Primary outcomes:
measure: Investigator's Global Assessment (IGA)
timeFrame: Day 1 to Day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DS Research
state: Kentucky
Study officials:
References:
Clinical trial NCT01844882: The Effects of Dietary Fiber in CKD: A Systematic Review and Meta-analysis
Official title: The Effects of Dietary Fiber on Uremic Retention Solutes in CKD: A Systematic Review and Meta-analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Keywords: The effects
dietary
fiber
kidney function
CKD patients
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with Chronic Kidney Disease (CKD)

Brief summary: Chronic kidney disease (CKD) is a debilitating condition in which there is a gradual decline of renal function associated with increased overall mortality. Most dietary guidelines for CKD focus on limiting protein intake (nitrogen) and high phosphorus-containing foods. However, increasing dietary fiber has been proposed to increase fecal nitrogen excretion which may ameliorate the progress of CKD. We therefore plan to conduct a systematic review and meta-analysis on clinical trials to assess the effect of fiber on urea and creatinine as classical markers of a state of uremia in individuals with CKD. We hypothesize that increasing fiber intakes will improve urea and creatinine levels in individuals with CKD.


Eligibility criteria: Inclusion Criteria:

* Dietary trials in humans
* Randomized treatment allocation
* Suitable control (low fiber)
* viable endpoint data

Exclusion Criteria:

* Non-human studies
* Nonrandomized treatment allocation
* Lack of a suitable control (high protein)
* no viable endpoint data

Primary outcomes:
measure: Creatinine
timeFrame: 1.5 years
measure: urea
timeFrame: 1.5 years
Secondary outcomes:
measure: Phosphorus
timeFrame: 1.5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Chiavaroli L, Mirrahimi A, Sievenpiper JL, Jenkins DJ, Darling PB. Dietary fiber effects in chronic kidney disease: a systematic review and meta-analysis of controlled feeding trials. Eur J Clin Nutr. 2015 Jul;69(7):761-8. doi: 10.1038/ejcn.2014.237. Epub 2014 Nov 12.
Clinical trial NCT03330782: Remifentanil for Preventing Propofol Injection Pain in Elderly Patients
Official title: Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Drug Usage
Keywords: pain
propofol
remifentanil
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 52
Sex: MALE
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly patients by the Dixon's up-and-down method.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II undergoing general anesthesia

Exclusion Criteria:

* neurologic disorder
* psychologic disorder
* vascular disorder
* patients with chronic pain
* difficulty in vascular access

Primary outcomes:
measure: Severity of propofol injection pain-4 point scale
timeFrame: during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Jong Yeop Kim
state: Gyeonggi-do
Study officials:
affiliation: Ajou University Hospital, Suwon, Gyeongki-do, South Korea, 443-721
name: Jong Yeop Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02450682: Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study
Official title: Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2015-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.


Eligibility criteria: 1. Signed informed written consent
2. Patients are taking warfarin or apixaban chronically
3. Patients are at risk of stroke or systemic embolism
4. Patients have NVAF
5. Patients will undergo CIED generator change
6. Age 18-90
7. Either gender
8. All eligibility criteria must be met

Exclusion:

1. Patient is critically ill, or in unstable condition
2. Patient is at high risk for bleeding, HAS-BLED score ≥ 3
3. Patient is required to take dual antiplatelet agents in addition to anticoagulant drug. (e.g. recent cardiac stent placement)
4. Patients have mechanical cardiac valve or another condition other than NVAF that requires chronic anticoagulation
5. Women of childbearing potential with positive pregnant test
6. Bilirubin \>2x upper limit of normal, in association with AST/ALT/ALP \>3x upper limit normal
7. Allergy to apixaban and warfarin
8. Subjects requiring taking strong dual inhibitors of CYP3A4 and P-gp who already meet the criteria to take 2.5 mg apixaban
9. Subjects requiring taking strong dual inducers of CYP3A4 and P-gp (.e.g., rifampin, carbamazepine, phenytoin, St. John's wort)
10. Patients who take any investigational drugs within 30 days of enrolling in study.
11. Prisoners or subjects who are involuntarily incarcerated.
12. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Primary outcomes:
measure: decrease in the hemoglobin level of 2 g per deciliter or more
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yong-Mei Cha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Samuel Asirvatham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04212182: The Physiological Effect of High Flow Oxygen Therapy
Official title: The Physiological Effect of High Flow Oxygen Therapy on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High-flow Nasal Cannula
Non-invasive Positive Pressure Ventilation
Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Although non-invasive positive pressure ventilation (NPPV) shows the good curative effect of treating the patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD), some patients do not tolerate NPPV or do not benefit from it. High-flow nasal cannula (HFNC) is well tolerated and may be used to patients with AECOPD who are intolerant to NPPV treatment. This study is to evaluate the physiological effect of HFNC and compare it with NPPV.


Eligibility criteria: Inclusion Criteria:

* AECOPD patients with acute hypercapnic respiratory failure

Exclusion Criteria:

* other lung/pleural diseases or thoracic deformity
* severe heart failure (New York Heart Association class IV), severe dysrhythmia
* unstable angina, or malignant comorbidity
* obesity (BMI ≥ 35 kg/m²)
* severe obstructive sleep apnea syndrome

Primary outcomes:
measure: Neural respiratory drive
timeFrame: 30 minutes
Secondary outcomes:
measure: Work of breathing
timeFrame: 30 minutes
measure: Transcutaneous CO2
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University.
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Rongchang Chen, MD
role: STUDY_CHAIR
References: