louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06459050: Effects of Isometric Conditioning Activity on Subsequent Jumping Performance in Volleyball Players
Official title: Effects of Overcoming Isometric Unilateral Conditioning Activity on Subsequent Single-Leg Drop Jump in Elite and Amateur Volleyball Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resistance Training
Keywords: resistance training
strength and conditioning
physical activity
athletic performance
Lead sponsor: The Jerzy Kukuczka Academy of Physical Education in Katowice
Sponsor class: OTHER
Collaborators: name: Charles University, Czech Republic
name: University School of Physical Education, Krakow, Poland
First posted: 2024-06-14
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study was performed following a randomized, double-blind crossover design, where each participant performed two experimental sessions.
Primary purpose: TREATMENT

Brief summary: The pairing of high-effort exercise, called conditioning activity, with a biomechanically similar high-velocity power movement is considered a valid method to effectively facilitate muscle power adaptations. Research has mainly focused on using this method in exercises performed by both limbs, even though sports tasks are often executed through motion sequences produced by a single limb alternately. However, available studies have focused solely on the dominant leg, leaving it unclear if the effectiveness is similar in both legs and how it transfers between them. Therefore, this study aims to evaluate the immediate effects of the isometric split squat exercise on single-leg drop jump performance in volleyball players, considering their training status.


Eligibility criteria: Inclusion Criteria:

* no lower-limb serious injury, including tendon or muscle tear,
* participation in regular resistance training and competition.
* for the elite group participants competed at the highest national volleyball league for at least two consecutive seasons.
* for the amateur group participants competed in junior groups outside the highest league level.

Exclusion Criteria:

-

Primary outcomes:
measure: Drop Jump Height
timeFrame: Immediately pre- and at 4th and 8th minute post-completion of conditioning activity.
measure: Drop Jump Contact Time
timeFrame: Immediately pre- and at 4th and 8th minute post-completion of conditioning activity.
measure: Drop Jump Reactive Strength Index
timeFrame: Immediately pre- and at 4th and 8th minute post-completion of conditioning activity.
Secondary outcomes:
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: The Jerzy Kukuczka Academy of Physcial Education in Katowice
state: Slask
Study officials:
References:
Clinical trial NCT03409523: An Observational Pilot Study to Develop a Behavioral Economics Electronic Health Record Module to Guide the Care of Older Adults With Diabetes
Official title: An Observational Pilot Study to Develop a Behavioral Economics Electronic Health Record Module to Guide the Care of Older Adults With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabete Mellitus
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Providers in NYU outpatient primary care, geriatrics, or endocrine clinics at NYU who care for older adults with diabetes

Brief summary: This study will develop a new electronic health record module to improve guideline-compliant care of older adults with diabetes. The module will incorporate effective behavioral economics (BE) principles to improve the degree to which care of older adults is compliant with Choosing Wisely guidelines; this generally involves less aggressive targets for HbA1c, and reductions of medications other than metformin.

The implementation of the module will ultimately be triggered by medication prescribing in EPIC. The BE principles include suggesting alternatives to medications, requiring justification, setting of appropriate default order sets, and incorporation of anchoring and checklists to guide behavior. The study will involve provider workflow analysis based on observation, module user testing, and live usability testing with direct observation and semi-structure interviews.

Detailed description: The primary objective of this study is to develop a scalable, EHR customization toolkit that applies BE insights to promote appropriate diabetes care in older adults based on the American Geriatric Society's Choosing Wisely Guideline, as to assess the acceptability of the resulting module.

Eligibility criteria: Inclusion Criteria:

* Providers in NYU outpatient primary care, geriatrics, or endocrine clinics at NYU who care for older adults with diabetes

Exclusion Criteria:

* None

Primary outcomes:
measure: Compliance with Choosing Wisely guidelines measured by number of reductions of medications
timeFrame: 60 Months
Secondary outcomes:
measure: Usability measured by module user testing with direct observation and semi structured interviews
timeFrame: 60 Months
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Andrea Troxel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Belli HM, Chokshi SK, Hegde R, Troxel AB, Blecker S, Testa PA, Anderman J, Wong C, Mann DM. Implementation of a Behavioral Economics Electronic Health Record (BE-EHR) Module to Reduce Overtreatment of Diabetes in Older Adults. J Gen Intern Med. 2020 Nov;35(11):3254-3261. doi: 10.1007/s11606-020-06119-z. Epub 2020 Sep 3.
Clinical trial NCT00198523: A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Official title: A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eye Infections
Postoperative Complications
Keywords: Cataract Extraction
Anti-Bacterial Agents
Steroids
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 132
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 this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.


Eligibility criteria: Inclusion Criteria:

* Bilateral cataract surgery
* Avoid disallowed medications throughout study

Exclusion Criteria:

* Contraindications to the use of the test agents
* Known allergy or sensitivity to the test agents or components
* History of steroid response following topical administration of corticosteroids in the eye
* Wore contact lenses 48 hours prior to Visit 1
* An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye
* Any significant illness that could be expected to interfere with study
* Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to surgery

Primary outcomes:
measure: Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Great Bend
country: United States
facility: Donald E. Beahm, MD
state: Kansas
city: Boston
country: United States
facility: Cornea Consultants/Laser Eye Consultants of Boston
state: Massachusetts
city: St. Joseph
country: United States
facility: Great Lakes Eye Care
state: Michigan
city: Portsmouth
country: United States
facility: Eyesight Ophthalmic Services, PA
state: New Hampshire
city: Austin
country: United States
facility: Texan Eye Care PA
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
Study officials:
affiliation: ISTA Pharmaceuticals, Inc.
name: Tim McNamara, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05154123: Drug-drug Interaction Study of Rosuvastatin and AT-527 (R07496998)
Official title: A Phase 1, Open-Label Study to Evaluate the Effect of AT-527 on the Pharmacokinetics of Rosuvastatin in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-12-10
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug-drug interaction study of rosuvastatin and AT-527 (R07496998)


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin
timeFrame: Day 1, Day 8
measure: To evaluate the effect of co-administration of AT-527 on the single-dose pharmacokinetics (PK) of rosuvastatin
timeFrame: Day 1, Day 8
measure: To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin
timeFrame: Day 1, Day 8
measure: To determine the effect of a staggered dose of AT-527 administered 2 hours before rosuvastatin on the PK of rosuvastatin
timeFrame: Day 1, Day 8
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Atea Study Site
state: Montreal, Quebec
Study officials:
References:
Clinical trial NCT05778123: Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury
Official title: Multiomic Analysis of Body Fluid in Acute Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Injuries, Traumatic
Keywords: Traumatic brain injury
Body fluid
Biomarker
Multiomic analysis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe traumatic brain injury or hydrocephalus.

Brief summary: The goal of this experimental observation study is to figure out differently expressed biomarkers in body fluid in traumatic brain injury patients. The main questions it aims to answer is:

* Which RNA, protein and metabolites are differently expressed in lesion tissues?
* What molecular mechanism is participated in TBI? Participants will be treated by emergency operation, and their body fluid samples will be collected in emergency room and during the operation.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 and \<65
2. Within 12 hours after brain injury
3. Control group is hydrocephalus
4. GCS ≥3 and ≤8
5. Closed brain injury with frontotemporal contusion
6. Need emergency intracranial hematoma evacuating or cerebrospinal fluid shunting operation
7. Patient's agents are informed and consent the research

Exclusion Criteria:

1. With TBI, stroke, ICH or intracranial tumor history
2. Death within 24 hours
3. Immunosuppression state
4. Severe organ dysfunction
5. Complicated infective disease
6. Pregnant

Primary outcomes:
measure: RNA biomarkers in patients' blood & cerebrospinal fluid assessed by transcriptome bioinformatic analysis
timeFrame: Immediately after collecting blood & cerebrospinal fluid
measure: Protein biomarkers in patients' blood & cerebrospinal fluid assessed by proteomic bioinformatic analysis
timeFrame: Immediately after collecting blood & cerebrospinal fluid
measure: Metabolite biomarkers in patients' blood & cerebrospinal fluid assessed by metabolomic bioinformatic analysis
timeFrame: Immediately after collecting blood & cerebrospinal fluid
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
References:
Clinical trial NCT04405323: Study That Evaluates the Effect of CYP3A4 Inhibition on Lu AG06466 in Healthy Men and Women
Official title: Interventional, Open-label, Randomized, Two-sequence Study Evaluating the Effect of CYP3A4 Inhibition on the Pharmacokinetics, Safety and Tolerability of Lu AG06466 in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2020-05-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A study to learn how a drug (itraconazole) that is known to inhibit a certain enzym in the liver, impacts the body's ability to breakdown Lu AG06466 into breakdown products in healthy men and women. The main breakdown product is Lu AG06988.

Detailed description: Two sequence study where Lu AG06466 will be dosed with and without food, Sequence 1 and Sequence 2. Each subject will receive single oral doses of Lu AG06466. Subject will be randomized to one of two sequences.

For inhibition of CYP3A4, each subject will receive a once daily dosage of itraconazole from Day 5 to Day 11.

Eligibility criteria: Inclusion Criteria:

* The subject has a BMI ≥18.5 and ≤30 kg/m2
* The subject is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, a neurological examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.
* The subject must not be of childbearing potential (if a woman) or should use contraception (both sexes). If women, the subject must not be pregnant or breastfeeding.

Exclusion Criteria:

* The subject is a poor metabolizer (PM) of CYP2C9 and/or CYP2C19.

Other in- and exclusion criteria may apply

Primary outcomes:
measure: AUC(0-inf) Lu AG06466
timeFrame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
measure: AUC(0-inf) Lu AG06988
timeFrame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
measure: Cmax Lu AG06466
timeFrame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
measure: Cmax Lu AG06988
timeFrame: From 0 to 48 hours post-dose on Day 1, 3, 8 and 10
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: US1517
state: Florida
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT02402023: Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery
Official title: Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-30
Enrollment: 40
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 this clinical trial is to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery.

Detailed description: The investigators are proposing a developmental interdisciplinary pilot study to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery. This study (a follow up to smaller pilot studies) will serve as a means to further develop a treatment protocol and to generate an accurate effect size for a full scale trial. The present study will constitute a development clinical trial with a primary aim of developing an effect size for smoking cessation at the time of surgery (7-day point prevalence abstinence), and a secondary aim of creating an effect size for long-term abstinence at 3 months post-surgery.

Eligibility criteria: Inclusion Criteria:

1. age 18 or older
2. smoking ≥ 1 cigarettes per day
3. CO \> 6 ppm
4. diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer
5. agreement on a 2-5-week pre-surgical tobacco intervention by both patient and surgeon, and 6) residence within reasonable driving distance to New Haven.

Exclusion Criteria:

1. unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
2. unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
3. pregnant or breastfeeding women
4. those with limited decision making capacity.

Primary outcomes:
measure: Pre Surgery Smoking Abstinence
timeFrame: Day of Surgery
Secondary outcomes:
measure: Post Surgery Smoking Abstinence
timeFrame: 3 months
Other outcomes:
measure: Continuous Smoking Abstinence
timeFrame: 3 months
measure: Perioperative Complications
timeFrame: 3 months
Locations:
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Yale University
name: Benjamin Toll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02866123: Verification of Correct Positioning of a Gastric Tube by Ultrasonography
Official title: Prospective Study to Evaluate Ultrasound Verification of the Correct Position of Gastric Tubes in Intensive Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insertion of a Nasogastric Tube
Intubated Patient
Patients Hospitalized in the Surgery Intensive Care Unit
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: There are several ways to verify the correct positioning of a gastric tube. Radiography is considered the reference method. The use of ultrasonography could diminish the number of radiographies necessary. The hypothesis of this research is that gastric ultrasonography performed during insertion of the tube is a reliable examination to check the correct positioning of gastric tubes in intensive care.


Eligibility criteria: Inclusion Criteria:

* Patients, or their persons of trust, in cases of coma or sedated patients) who have given informed oral consent
* All patients hospitalized in the surgery intensive care unit of Dijon CHU, who are intubated and require a gastric tube

Exclusion Criteria:

* Adults under guardianship, patients under 18 years of age
* Patients without national health insurance cover
* Pregnant women
* Wound or dressing preventing gastric ultrasonography (laparotomy is not an exclusion criterion if the dressing does not prevent ultrasonography being performed)
* result of the radiographic verification seen before the gastric ultrasonography is done

Primary outcomes:
measure: Number of ultrasonography examinations validating the correct insertion of a nasogastric tube (NGT)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT00173823: Malnutrition and Inflammation in Dialysis Patients in Taiwan
Official title: Malnutrition and Inflammation in Taiwan: Prospective Outcome Evaluation Method (MIT-POEM) in Dialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodialysis
Hypercholesterolemia
Malnutrition
Inflammation
Kidney Failure, Chronic
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: According to the reports of the United States Renal Data System (USRDS), there is a 25% annual mortality rate with nearly 50% of all reported maintenance hemodialysis (HD) patient deaths attributed to atherosclerosis-related complications. Although traditional risk factors of cardiovascular disease (CVD) are common in end-stage renal disease (ESRD) patients, they alone may be insufficient to account for their high prevalence of CVD. Recent evidence demonstrated high plasma homocysteine levels have been established as a risk factor of chronic inflammation and atherosclerosis in patients with ESRD.

Malnutrition and inflammation was associated with poor quality of life, morbidity and mortality. We, the researchers at National Taiwan University Hospital, hope to establish the best predictive profile of HD patient outcome. Thus, we establish several protocols to complete this work.


Eligibility criteria: Inclusion Criteria:

* On HD three times a week for more than 3 months (minimizing the confounding effects of residual renal function)

Exclusion Criteria:

* Malignancy;
* Obvious infections or inflammatory diseases;
* Preexisting haematological disorders; and,
* Clinically significant bleeding, transfusion, hospitalization, surgery, or renal transplantation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital and collegues
Study officials:
affiliation: National Taiwan University Hospital
name: Chih-Kang Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References: