louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03968016: Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population
Official title: Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnoses Disease
Keywords: Acute Myocardial Infarction
Cardiac marker
Troponin
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators aimed to study the cut-off of high sensitivity troponin T using SYSMEX HLSCL Machine in Thai population at percentile 99.


Eligibility criteria: For healthy group

Inclusion Criteria:

* Group 1: Aged 18 - 40 years
* Group 2: Aged \> 40 - 70 years
* A presumably healthy population will define from a health questionnaire

Exclusion Criteria:

* Heart diseases
* Renal diseases (CKD or recent AKI)
* History of pulmonary embolism

For Patient group with stable heart diseases

Inclusion Criteria:

* Aged \> 40 - 70 years
* Stable heart disease individuals will be evaluated by cardiologist
* Non hospitalized (OPD settings)

Exclusion Criteria:

* Stable heart diseases with ACS
* Renal diseases (CKD or recent AKI)
* History of pulmonary embolism

Primary outcomes:
measure: Measurement of high sensitivity-troponin T level
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Chulalongkorn University
state: Bangkok
Study officials:
References:
Clinical trial NCT00538616: Precedex Versus Propofol-Awakening for Reducing Brain Injury Expansion
Official title: A Phase IV Single Center Cross Over Clinical Study Comparing Two Different Sedations Strategies for Mechanically Ventilated Patients With Neurological Critical Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Brain Injury
Intracranial Pressure
Keywords: Brain Injury
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Hospira, now a wholly owned subsidiary of Pfizer
First posted: 2007-10-02
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate brain injury when two different drugs (propofol and precedex) are used to sedate patients who need a neurologic exam.

Detailed description: The hypothesis is that a neurologic exam performed when the subject has continuous infusion of precedex will result in less brain injury (where the lactate/pyruvate ratio indicates injury) then when a neurologic exam is performed on subjects receiving propofol, because that exam requires that the propofol infusion be stopped.

Eligibility criteria: Inclusion Criteria:

* primary diagnosis of Traumatic Brain Injury (TBI), Subarachnoid Hemorrhage (SAH),Intracranial Hemorrhage (ICH), stroke
* Must require (be on) mechanical ventilation
* must require (have in place) intracranial pressure (ICP) monitoring
* must require (be receiving) continuous IV sedation

Exclusion Criteria:

* Bleeding diathesis
* Glasgow Coma Scale (GCS) \< 5 with fixed pupils
* Pregnant
* elevated ICP that requires deep sedation
* pulmonary instability
* Hx of Ethanol(ETOH) abuse that requires current benzodiazepine treatment for delirium - allergy to propofol or precedex
* status epilepticus
* current neuromuscular blockade

Primary outcomes:
measure: Lactate/Pyruvate (L/P)Ratio
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Carmelo Graffagnino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: DaiWai M Olson, PhD RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01316016: Antidiabetic Properties of Rose Hip
Official title: Effects of Rose Hip Intake on Risk Markers of Type 2 Diabetes and Cardiovascular Disease: a Randomized Double-blind Cross-over Investigation in Obese Persons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
glucose intolerance
cholesterol
blood pressure
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2011-03-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether daily intake of a drink containing rose hip powder reduces risk markers of type diabetes and cardiovascular disease.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30
* willingness to participate in the study
* willingness to comply with the daily intake of drinks and the recommended energy intake during the course of the study

Exclusion Criteria:

* diabetes
* previous or ongoing insulin treatment
* abnormal thyroid status
* abnormal liver status
* abnormal kidney status
* known gastrointestinal disorder
* pregnancy
* suspected allergy to ingredients of the drinks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Endocrinology Clinic, Lund University Hospital
Study officials:
affiliation: Lund University
name: Per Katzman, MD/PhD
role: STUDY_CHAIR
References:
citation: Andersson U, Henriksson E, Strom K, Alenfall J, Goransson O, Holm C. Rose hip exerts antidiabetic effects via a mechanism involving downregulation of the hepatic lipogenic program. Am J Physiol Endocrinol Metab. 2011 Jan;300(1):E111-21. doi: 10.1152/ajpendo.00268.2010. Epub 2010 Oct 19.
Clinical trial NCT02617316: The Different Running Speeds of Strike Patterns
Official title: Analysis of the Different Running Speeds of Strike Patterns: The Efficiency of Shoes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: running speeds, strike patterns
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 20
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this research is to investigate the differences of landing patterns while running in different speed with barefoot and wearing shoe.

Detailed description: Running speed will be adjusted with physical strength and circumstance. When speed changes, whether the landing patterns change or not may be one factor of sports injuries. Therefore, the purpose of this research is to investigate the differences of landing patterns while running in different speed with barefoot and wearing shoe.

Eligibility criteria: Inclusion Criteria:

* To jog at least three times a week, each time lasted for more than 20 minutes
* No smokers
* No musculoskeletal diseases within 6 months

Exclusion Criteria:

Primary outcomes:
measure: The percentage of three kinds of landing patterns.
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Sports Medicine, College of Medicine, Kaohsiung Medical University
name: Lan Y Guo, Ph.D
role: STUDY_CHAIR
References:
citation: Nigg BM, Biomechanics, Load Analysis and Sports Injuries in the Lower-Extremities. Sports Medicine 2(5): 367-379, 1985. Hasegawa H, Yamauchi T, Kraemer WJ. Foot strike patterns of runners at the 15-km point during an elite-level half marathon.Journal Strength Cond Research,21(3): 888-893, 2007. Cavanagh PR, Lafortune MA. Ground reaction forces in distance running. J Biomech 13(5): 397-406, 1980 Shih Y, L KL, TY Shiang. Is the foot striking pattern more important than barefoot or shod conditions in running? Gait Posture 38(3): 490-494, 2013.
Clinical trial NCT00616616: Single Incision Laparoscopy
Official title: Single Incision Laparoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appendicitis
Cholelithiasis
Malignant Hypertension
Keywords: appendectomy
cholecystectomy
gastric banding
adrenalectomy
Gastric lap-band placement
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2008-02-15
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Laparoscopic surgery being performed with only one small incision via the umbilicus (belly button).


Eligibility criteria: Inclusion Criteria:

1. Ages 18-75
2. Patient has consented for a laparoscopic operation (independent of study participation)
3. Attending surgeon decides operation can be completed via a single incision laparoscopic approach

Exclusion Criteria:

1. Patients with BMI greater than 40
2. Minors and cognitively impaired individuals
3. Patients who are ASA class IV - Illness that is a constant threat to life
4. Patients with ascites or Child's class C of liver failure
5. Patients with known common bile duct stones
6. Patients with coagulopathy, abnormal coagulation studies, or who take heparin, coumadin, Plavix (clopidogrel), aspirin, or other medication for the purpose of anti-coagulation and cannot be removed from the medication prior to the operation.
7. Patients who present with incarcerated (irreducible) or strangulated hernias
8. Patients with preoperative hematocrits less than 25.
9. Preoperative hematocrit less than 25.
10. Patients who have evidence of hemodynamic instability including systolic blood pressure greater than 200 or less than 80.
11. Heart rate greater than 130 or less than 50. Respiratory rate greater than 35 or less than 6. Patients who are on continuous pressor drip for blood pressure support.
12. Patients who present for emergency adrenalectomy.
13. Patients with CT scan evidence of an abdominal abscess.
14. Patients who present 48 hours after the onset of abdominal pain (appendectomy patients)

Primary outcomes:
measure: Evaluate the safety and efficacy of single incision laparoscopy
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Santiago Horgan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02587416: Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers
Official title: A Study of the Effect of Oral, Multiple-Dose 300 mg and 900 mg Gemcabene (CI-1027) Administration on the Steady-State Pharmacokinetics of Atorvastatin 80 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesteremia
Keywords: Pharmacokinetics
Lipid Regulator
Lead sponsor: NeuroBo Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg


Eligibility criteria: Inclusion Criteria:

* Males and Females
* 18-65 years of age
* Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements;
* Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight \[kg\]/height\[meters\]²)

Exclusion Criteria:

* If female, of childbearing potential or lactation
* History of significant adverse reaction to any lipid-lowering agent

Primary outcomes:
measure: Pharmacokinetics
timeFrame: Days 5, 16 and 27
measure: Pharmacokinetics
timeFrame: Days 5, 16, and 27
Secondary outcomes:
measure: Adverse Events
timeFrame: 27 days
measure: Clinical Laboratory - hematology, chemistry, urinalysis
timeFrame: 27 days
measure: ECG
timeFrame: 27 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00923416: Trans-Rectal Ultrasound-Guided (TRUS) Adverse Events
Official title: A Prospective Quantification of Patient-Reported Adverse Events Following Trans-Rectal Ultrasound-Guided Intra-Prostatic Marker Insertion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Intra-Prostate Markers
Transrectal Ultrasound
Prostate Cancer Patients
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2009-06-18
Enrollment: 240
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate Cancer Patients who has trans-rectal ultrasound-guided implantation of intra-prostatic markers for radiotherapy treatment

Brief summary: The goal of this study is to identify any side effects caused by the implanting of markers via the rectum. The investigators will also try to determine if any other factors (such as the position of the markers) influence the risk of side effects. The study procedures consist of two questionnaires:The first will be completed immediately after the marker implantation and the second questionnaire will be completed during your radiotherapy planning.

Detailed description: Precise localisation of target organs has become increasingly important with the routine use of steep dose gradients from conformal and intensity modulated radiotherapy. This is particularly challenging when soft tissue target organs, such as the prostate, displace relative to bony anatomy. Although novel imaging techniques are being developed for the direct visualisation of such soft tissue structures, contrast and image quality is currently limited. However, the use of radio-opaque intra-prostatic fiducial markers(IPM) during high dose radiotherapy has proven very effective in terms of improving accuracy, and decreasing toxicity.

Eligibility criteria: Inclusion Criteria:

* Have biopsy confirmed prostate cancer (any risk category)
* Have 3 intra-prostatic markers inserted at PMH prior to radiotherapy
* Be willing to provide written informed consent
* Be willing to complete the adverse event questionnaires

Primary outcomes:
measure: Quantify adverse events reported by prostate patients following trans-rectal ultrasound-guided implantation of intra-prostatic markers for RT
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: Tara Rosewall
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06540716: Inspire Singapore Study
Official title: Inspire Singapore Study: Confirmation of Therapy Performance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
OSA
Sleep Apnea
Lead sponsor: Inspire Medical Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-06
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, multicenter, open-label study designed to confirm device performance of Inspire system in Singapore.

Detailed description: Patients who meet study eligibility criteria will be implanted with an Inspire system and followed for 6 months post-therapy-activation. Study subjects will undergo in-lab sleep studies to confirm inspiratory overlap (1st PSG, after therapy activation), titrate the therapy (2nd PSG, at 3 months post-activation) and confirm therapy performance (3rd PSG, at 6 months post-activation). Symptoms and quality of life (assessed by ESS and FOSQ), therapy adherence, and adverse events will also be collected and reported.

Eligibility criteria: Main Inclusion Criteria:

* Diagnosis of moderate to severe OSA (AHI 15-65)
* Failure of, or intolerance to CPAP

Main Exclusion Criteria:

* Central + mixed apneas \> 25% of total AHI
* Presence of complete concentric collapse (CCC)
* Compromised neurological control of the upper airway.

Other eligibility criteria may apply.

Primary outcomes:
measure: Inspiratory Overlap
timeFrame: 0-3 months post-therapy activation
Secondary outcomes:
measure: Therapy Effectiveness
timeFrame: 6 months post-therapy activation
measure: Symptom Reduction
timeFrame: 6 months post-therapy activation
Other outcomes:
measure: Rate of Adverse Events
timeFrame: 6 months post-therapy activation
measure: Therapy Adherence
timeFrame: 6 months post-therapy activation
measure: Functional Outcomes of Sleep Questionnaire (FOSQ) Score
timeFrame: 6 months post-therapy activation
measure: Inspiratory Overlap
timeFrame: 6 months post-therapy activation
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Toh Song Tar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06848816: Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis (AGPN): Effect on the Risk of Recurrence
Official title: DUTRAPYL STUDY : Duration of Antibiotic Therapy in Acute Kidney Graft Pyelonephritis: Effect on the Risk of Recurrence
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pyelonephritis Acute
Kidney Transplantation Recipients
Keywords: Acute graft pyelonephritis
duration treatment
antibiotic
recurrence
relapse
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patient with AGPN during the study period

Brief summary: The aim of this study is to evaluate the impact of the duration of antibiotic therapy on the risk of recurrence in kidney graft pyelonephritis. The secondary objectives are to identify the factors associated with the duration of antibiotic therapy in acute kidney graft pyelonephritis, identify the factors associated with recurrence of acute kidney graft pyelonephritis within 3 months, evaluate the impact of the duration of antibiotic therapy on antibiotic-related complications and assess the impact of the duration of antibiotic therapy on the progression of renal function after acute kidney graft pyelonephritis.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Kidney transplant recipients with a functional graft.
* Hospitalization with acute pyelonephritis (APN) defined by fever OR chills (noted in the clinical records) AND bacteriuria AND exclusion of another obvious cause of fever. (For rehospitalizations, also include cases where antibiotic therapy was initiated based on suspicion, even in the absence of documented infection.)

Exclusion Criteria:

* Age \< 18 years.
* Vacationing patient or lost to follow-up with follow-up \< 3 months.

Primary outcomes:
measure: Relaspe AGPN
timeFrame: 3 month
Secondary outcomes:
measure: Early AGPN relapse
timeFrame: 1 month
measure: ITU relapse
timeFrame: 3 month
measure: Identical microorganism relapsing AGPN
timeFrame: 3 month
measure: Multidrug resistant emerging pathogens
timeFrame: 3 month
measure: Clostridioides difficile colitis
timeFrame: 3 month
measure: Early kidney function evolution
timeFrame: 1 month
measure: 3 month kidney function evolution
timeFrame: 3 month and 21 days
measure: Risk factors
timeFrame: 3 month
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHU de Nancy
Study officials:
References:
Clinical trial NCT03293316: Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study
Official title: Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inter-individual Variability
Keywords: Transcranial electrical stimulation; random noise;
cognitive interventions; electroencephalography;
inter-individual variability; stochastic resonance;
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Inter-individual variability in responsiveness to interventions poses great challenges for translational neuroscience, and health care in general. The investigations sought to examine the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate sustained attention in a manner that was informed by individual differences in EEG indices.

Detailed description: Inter-individual variability in responsiveness to interventions poses great challenges for translational neuroscience, and health care in general. Reliable and cost- effective screening procedures that can identify individuals who are more likely to benefit from an intervention could have substantial real-world benefits. Here, the investigators sought to examine the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate sustained attention in a manner that was informed by individual differences in a well-studied electrocortical marker, spontaneous theta/beta ratio. The investigators hypothesized that individuals with relatively high theta/beta ratios, putatively reflecting suboptimal cortical arousal, would be more likely to benefit from the gains in cortical excitability afforded by tRNS. Seventy-two young healthy adults were administered 1mA, 2mA and sham tRNS in a double-blind, randomised, cross-over manner, while they performed a continuous monitoring paradigm. Electroencephalography was acquired before and after each stimulation condition.

This approach may constitute a feasible means of using individual differences in neurophysiology to inform predictions about outcomes from targeted cognitive interventions.

Eligibility criteria: Inclusion criteria:

- Aged 18-35 years

Exclusion criteria:

* Left-handedness
* Visual impairment
* History of fainting,
* History of neurological or psychiatric illness,
* Neurological insult
* Drug or alcohol abuse
* Reporting current use of anti- psychotic or anti-depressant medications

Primary outcomes:
measure: Electroencephalography
timeFrame: 4 minutes
Secondary outcomes:
measure: Sustained Attention performance
timeFrame: 20 minutes
Other outcomes:
Locations:
Study officials:
References: