louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00158769: A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers
Official title: An Open-Label, Non-Randomised, Pharmacokinetic, Metabolic Disposition and Safety Study of a 3 Day Continuous Infusion of GR270773 in Healthy Subjects and Subjects With Hepatic Impairment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sepsis
Keywords: Hepatic Impairment
GR270773
Emulsion
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 16
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: This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids are broken down in the body by the liver. This study is designed to see whether the effect of the drug in people with poorly functioning livers is any different to the effect on healthy adults.


Eligibility criteria: Inclusion criteria:

* Patients with known history of liver disease (either with or without history of alcohol abuse).
* Previous confirmation of liver cirrhosis by liver biopsy or other medical imaging technique.
* Child-Pugh score of 7-9 (moderate impairment) BMI 19-29 Kg/m2.
* Healthy volunteers to match the hepatically impaired subjects in a 1:1 ratio by gender, age, BMI.

Exclusion criteria:

* Lactating or pregnant females.
* Subjects with BP \> 160/90.
* Subjects who, within the past six months, have had a history of significant drug or alcohol abuse, or any indication of regular use of more than 14 units of alcohol per week for women, or 21 units/week for men.

Primary outcomes:
measure: Compare drug concentrations in the blood between patients with impaired liver function and normal healthy adults, after 72 hours. Determine whether administration of study drug alters the lipid make-up of healthy adults in any way.
timeFrame: Up to Day 16
Secondary outcomes:
measure: Determine drug concentrations in blood after 2 hour run-in period and after 72 hour infusion period. Determine whether administration of study drug alters the lipid make-up of patients with impaired liver function in any way.
timeFrame: Up to Day 16
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01965769: Effects Of Not Measuring Gastric Residual Content On Feeding Tolerance In Premature Infants iNFANTS
Official title: Effects Of Not Measuring Gastric Residuals Prior To Enteral Bolus Feeding On Gastrointestinal Function And Feeding Tolerance In Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Keywords: Very low birth weight infants
premature
nutrition
gastric residual
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2013-10-18
Enrollment: 61
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Omitting evaluation of gastric residual contents prior to feeding very premature infants will increase the feeding intake at 2 weeks, and total caloric intake and growth by 3 weeks, as well as decrease the time required for parenteral nutrition.

Detailed description: Infants were randomized into 2 groups. Group 1 had no gastric residuals evaluated prior to feeding. Group 2 had gastric residuals evaluated prior to feeding. Nutritional outcomes were compared between groups.

Eligibility criteria: Inclusion Criteria:

* Gestational age less than 32 weeks,
* Birth weight less than or equal to 1250 grams,
* Initial feeding tolerated within 48 hours of life

Exclusion Criteria:

* Congenital or chromosomal disorders,
* Severe complications leading to death in the first week of life

Primary outcomes:
measure: Amount of feeding intake at 2 weeks
timeFrame: Baseline to 2 weeks
Secondary outcomes:
measure: Days to 120 mL/kg/d of enteral feedings
timeFrame: Baseline to approximately 21 days
measure: Days of parenteral nutrition
timeFrame: Baseline to approximately 21 days
measure: Incidence of late onset sepsis
timeFrame: Baseline to approximately 90 days
measure: Weekly or biweekly liver function tests
timeFrame: Baseline to 42 days
measure: Growth indices
timeFrame: Baseline to approximately 90 days
measure: Length of hospital stay
timeFrame: Baseline to approximately 90 days
measure: Incidence of necrotizing enterocolitis
timeFrame: Baseline to approximately 90 days
measure: Days requiring a central venous line
timeFrame: Baseline to approximately 21 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF & Shands Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Josef Neu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05250869: Comparative Quantification of MTX and Its Metabolites Post Glucarpidase
Official title: Comparative Quantification of MTX and Its Metabolites in Acidified vs. Non-acidified Blood Samples Post Glucarpidase Using HPLC/MS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma
Acute Lymphatic Leukemia
Keywords: Preanalytical Conditions
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-02-22
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with high-dose Methotrexate and Glucarpidase

Brief summary: Acidification (i.e., addition of hydrochloric acid) of plasma samples from patients who have received Glucarpidase post high-dose MTX treatment is regarded as a necessary preanalytic step to avoid further in vitro enzymatic cleavage of MTX. However, it is unclear whether this acidification step is essential. A comparative study, which evaluates concentrations of MTX and its metabolites in paired (acidified versus non-acidified) plasma samples, has not yet been performed. Processing plasma samples without acidification would facilitate quantification of MTX, including plasma samples from patients treated at centers without adequate laboratory facilities.

Detailed description: Stored plasma samples (paired - acidified and non-acidified) from the specimens collection ('Tumorbiobank') of the Charité Comprehensive Cancer Center will be analysed by HPLC/MS.

A total of 136 samples from patients post Voraxaze across 3 levels of MTX concentrations:

30 without additive, 10 with 0.9% NaCl, 30 with HCl (stored at -80C) 9 without additive, 9 with HCl (stored at +4C and analysed after 3-5 days) 9 without additive, 9 with HCl (stored at -20C and analysed after 3-5 days) 30 with HCl (stored at +4C versus ambient temperature)

Eligibility criteria: Inclusion Criteria:

* Treatment with Glucarpidase

Exclusion Criteria:

* Lacking patient consent

Primary outcomes:
measure: Consistency of MTX concentrations in paired acidified vs. non-acidified samples
timeFrame: within 3 days of Glucarpidase treatment
Secondary outcomes:
measure: Consistency of MTX concentrations in paired samples stored at -80C vs. +4C vs. ambient temperature
timeFrame: within 3 days of Glucarpidase treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
Study officials:
References:
citation: Knornschild FL, Liebig S, Kiessling P, Prpic M, Kim T, Keller U, Kappert K, Schwartz S, Jahic A. Simplified preanalytical laboratory procedures for therapeutic drug monitoring (TDM) in patients treated with high-dose methotrexate (HD-MTX) and glucarpidase. Clin Chem Lab Med. 2024 Jul 15;63(1):e11-e15. doi: 10.1515/cclm-2024-0523. Print 2025 Jan 29. No abstract available.
Clinical trial NCT01185769: Study of Tocotrienol Absorption and Distribution Under Different Fat Status
Official title: Mechanism of Absorption and Distribution of Tocotrienols Under Different Food Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Absorption
Keywords: Vitamin E
Absorption
Lead sponsor: Malaysia Palm Oil Board
Sponsor class: OTHER_GOV
Collaborators: name: University of Malaya
First posted: 2010-08-20
Enrollment: 10
Sex: MALE
Minimum age (years): 22
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Despite the emerging interest in tocotrienols, the absorption of tocotrienols in humans remains unclear especially with different fat diets.This study aimed at evaluating the absorption and distribution of tocotrienols in plasma and lipoproteins in associations with high and low fat diets. Different fat level will affect the absorption and distribution of tocotrienols

Detailed description: There is a possibility that the absorption and distribution of tocotrienols may occur differently compared with tocopherols, especially under different fat status

Eligibility criteria: Inclusion Criteria:

* male aged 22-25
* body mass index 18.5 \< X \< 30 kg/m2
* plasma cholesterol \< 5.2 mmol/L,
* TAG \< 1.7 mmol/L

Exclusion Criteria:

* history of cardiovascular disease
* diabetic
* body mass index \< 18.5 or \> 30 kg/m2
* plasma cholesterol \> 5.2 mmol/L,
* TAG \> 1.7 mmol/L
* hypertension
* currently taking Vitamin E supplement
* current use of medication
* smoking.

Primary outcomes:
measure: Difference in absorption and distribution of Tocoterienols during high fat and low fat meal by measuring the plasma, chylomicron, and HDL level of tocotrienol
timeFrame: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 24 hours after tocotrienol administration and in take of designated meal
Secondary outcomes:
Other outcomes:
Locations:
city: Bangi
country: Malaysia
facility: Malaysian Palm Oil Board
state: Selangor
Study officials:
affiliation: Malaysia Palm Oil Board
name: Weng-Yew Wong, Bsc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06478069: Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization
Official title: Postural Assessment of Stroke Patients by Pose Estimation and Effects of Dynamic Core Postural Chain Stabilization Techniques
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study focuses on a two-pronged strategy to enhance the rehabilitation of stroke patients. It first investigates the application of pose estimating technologies to objectively measure posture.

Detailed description: This can entail capturing a patient's body position with cameras or other sensors in order to detect any imbalances or variations from normal posture brought on by the stroke. The study also looks at how well dynamic core postural chain stabilization (DCS) methods work for stroke recovery. The goal of DCS exercises is to increase stability and strength in the core, which can help with general postural control. This research aims to optimize stroke patient rehabilitation by combining a precise evaluation approach with a focused intervention strategy, which may result in improved balance, movement, and functional abilities.

Eligibility criteria: Inclusion Criteria:

* Stroke, either ischemic or hemorrhagic
* Standing ability and ability to perform basic movements with assistance
* Willingness to take part in the intervention and evaluations

Exclusion Criteria:

* Severe cognitive impairment hindering participation
* Unstable medical conditions affecting rehabilitation
* History of other neurological disorders affecting posture

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 12 Months
measure: Trunk Impairment Scale (TIS) Score
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Sevices Hospital Shadman 1
state: Punjab
Study officials:
References:
Clinical trial NCT05432869: Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
Official title: Effects of External Electrical Stimulating Applied on the Thigh in Men With Urinary Incontinence After Prostatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 40
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the effects of external electrical stimulation applied on the thigh on urinary symptoms, quality of life, sexual function, perception of subjective improvement and satisfaction in men with urinary incontinence after prostatectomy

Detailed description: The most common complication after prostatectomy surgeries is urinary incontinence. There are conservative and surgical treatment options in post-prostatectomy urinary incontinence. One of the conservative treatment options is electrical stimulation application.

Electrical stimulation with the intraanal probe in men is painful and uncomfortable.

And also there are few studies, demonstrating the effects of electrical stimulation on urinary incontinence after prostatectomy in the literature.

Eligibility criteria: Inclusion Criteria:

* Being a male individual with stress or stress-dominant mixed urinary incontinence symptoms after undergoing prostatectomy surgery
* Being over 40 years old
* Not having residual cancerous tissue
* Volunteering to participate in the study

Exclusion Criteria:

* Having serious cardiovascular disease (unstable angina and arrhythmia patients, heart failure patients, etc.)
* Having sensory loss
* Having an ongoing urinary infection
* Having only urgency urinary incontinence
* Using a pacemaker
* Receiving active cancer treatment (radiotherapy, chemotherapy)
* Those who have a problem that interferes with cooperation and understanding

Primary outcomes:
measure: Urinary incontinence severity
timeFrame: change from baseline at 4 weeks
Secondary outcomes:
measure: Presence of urinary incontinence symptoms
timeFrame: change from baseline at 4 weeks
measure: Life quality
timeFrame: change from baseline at 4 weeks
measure: Sexual function
timeFrame: change from baseline at 4 weeks
measure: Perception of Subjective Improvement
timeFrame: after treatment (4th week)
measure: Patients Satisfaction
timeFrame: after treatment (4th week)
measure: Compliance with Lifestyle Advices
timeFrame: after treatment (4th week)
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05102669: Spike-specific Cellular Immune Response After COVID-19 Vaccination
Official title: Spike-specific Cellular Immune Response After COVID-19 Vaccination
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID19
Vaccination
Immune Response
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IRCCS San Raffaele Roma health care workers

Brief summary: Aim of this study is to evaluate whether COVID-19 vaccination induces a persistent cellular immune response.

To this aim, blood samples are taken from vaccinated individuals and not immunized subjects as a control group.

Cells isolated from blood samples are tested in vitro to assess the percentage of spike-specific T and B lymphocytes 1 and 7 months after a second dose of Comirnaty vaccine.

Detailed description: After providing written informed consent, 28 vaccinated and 25 non vaccinated subjects were included in the study. All subjects were enrolled among healthcare workers in the Research Centre of IRCCS San Raffaele Roma in Rome.

All the subjects declared that they never tested positive for COVID19. Blood and serum samples were drowned twice from vaccinated subjects: 1 and 7 months after a second dose of vaccine to evaluate T and B response to vaccine; blood was drowned once in not vaccinated subjects.

Cells were collected form peripheral blood samples, while anti-S1 IgG titre was assessed in serum.

Flow-cytometry was used to assess the percentage of circulating spike-specific T and B lymphocytes.

Eligibility criteria: Inclusion Criteria:

* vaccinated and non vaccinated subjects
* subjects that never tested positive for COVID19

Exclusion Criteria:

* subjects that tested positive for COVID-19

Primary outcomes:
measure: measurement of cellular response
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: IRCCS San Raffaele Roma
Study officials:
affiliation: IRCCS San Raffaele Roma
name: Laura Vitiello, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04425668: Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry
Official title: Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry: a Randomized Quality Improvement Effort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Prescribing
Pain Management
Keywords: Dentist
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
First posted: 2020-06-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this project is to improve quality of care for dental patients in the state of Michigan. This will be achieved through educating dentists about best practices for opioid prescribing and includes three continuing education (CE) credits and one (or two) academic detailing (AD) visits. The cohort of 90 dentists who are enrolled to the CE will be randomized into two groups upon enrollment. One of these groups, half of the cohort, will receive the academic detailing. A report will be written highlighting key findings from this project and best practices for treating patients after dental care.The quality of care for dental patients will be improved by sharing this information with both participating and non-participating dental providers statewide through reports, manuscripts, and presentations. These data will inform best practice with the potential for future academic detailing and educational interventions for dentists and oral surgeons.


Eligibility criteria: Inclusion Criteria:

* Dentists in the state of Michigan with an active drug enforcement agency (DEA) license.

Exclusion Criteria:

* All oral Surgeons in Michigan. Michigan dentists who have a significant (\>5%) population living outside of Michigan (self-reported), as the prescription drug monitoring program (PDMP) data we will obtain from Michigan Automated Prescription Service (MAPS) will only cover those prescriptions filled in the state of Michigan.

Primary outcomes:
measure: Change in the amount of opioid prescribed measured in the total oral morphine equivalents
timeFrame: baseline, up to 3 months
Secondary outcomes:
measure: Change in the number of opioid prescriptions
timeFrame: baseline, up to 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Chad Brummett
state: Michigan
Study officials:
affiliation: University of Michigan
name: Chad Brummett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06869668: The Relationship Between Disability, Fear Avoidance Beliefs, Physical Performance and Quality of Life in Chronic Low Back Pain
Official title: The Relationship Between Disability, Fear Avoidance Beliefs, Physical Performance and Quality of Life in Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Back Pain
Chronic Low-back Pain (cLBP)
Keywords: low back pain
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic low back pain

Brief summary: The aim of this study was to determine the multidimensional profile of individuals with chronic low back pain (CLBP) and to determine the relationship between disability and fear avoidance beliefs, physical performance and quality of life in this population. Individuals with chronic low back pain between the ages of 18-50 will be included in the study. Disability level of the participants will be assessed with Oswestry Disability Index (ODI), fear avoidance attitudes with Avoidance Beliefs Questionnaire-Physical Activity (FABQ-PA), and quality of life with Short Form-12 (SF-12). Trunk endurance, functional mobility and static-dynamic balance will be assessed for physical performance. Trunk endurance will be assessed with McGill endurance tests, functional mobility with Timed Up and Go Test (TUG), dynamic balance with Y-balance test, and static balance with single leg stance test.


Eligibility criteria: Inclusion Criteria:

* Back pain for at least 3 months
* Pain intensity ≥ 3 on the Visual Analog Scale

Exclusion Criteria:

* History of spinal surgery/trauma
* Other back pain (associated with rheumatic diseases, multiple sclerosis, malignancy, etc.) instability conditions such as spondylolysis and spondylolisthesis
* Pregnancy
* Obesity (BMI ≥ 30 kg/m²)
* Presence of orthopedic problems or chronic diseases that may interfere with testing

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Day 1
measure: Fear Avoidance Beliefs Questionnaire
timeFrame: Day 1
measure: Short Form-12/SF-12
timeFrame: Day 1
measure: McGill Trunk Muscle Endurance Tests
timeFrame: Day 1
measure: Timed Up and Go Test (TUG)
timeFrame: Day 1
measure: Y balance test
timeFrame: Day 1
measure: Single leg stance test
timeFrame: Day 1
measure: Visual Analog Scale
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Buyukcekmece
Study officials:
References: