louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00556361: Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Official title: Use of Ketamine Prior to Cardiopulmonary Bypass in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ventricular Septal Defect
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2007-11-12
Enrollment: 24
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess whether the drug ketamine given prior to cardiopulmonary bypass can decrease injury to the cells in the brain.


Eligibility criteria: Inclusion Criteria:

* less than one year of age
* undergoing cardiac surgery for repair of ventricular septal defect
* requiring cardiopulmonary bypass
* not requiring retrogrades cerebral perfusion

Exclusion Criteria:

* Downs Syndrome

Primary outcomes:
measure: To compare expression of serum markers of CNS injury
timeFrame: within 48 hours
measure: to compare expression of multiple pro and anti-inflammatory cytokines between cases and controls.
timeFrame: within 48 hours
Secondary outcomes:
measure: to compare the clinical, radiological and neurodevelopmental outcomes of the cases and controls
timeFrame: one month
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Adnan T Bhutta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bhutta AT, Schmitz ML, Swearingen C, James LP, Wardbegnoche WL, Lindquist DM, Glasier CM, Tuzcu V, Prodhan P, Dyamenahalli U, Imamura M, Jaquiss RD, Anand KJ. Ketamine as a neuroprotective and anti-inflammatory agent in children undergoing surgery on cardiopulmonary bypass: a pilot randomized, double-blind, placebo-controlled trial. Pediatr Crit Care Med. 2012 May;13(3):328-37. doi: 10.1097/PCC.0b013e31822f18f9.
Clinical trial NCT01829061: Reproducibility and Method Comparison Studies of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver Study of the Quo-Test™ A1C System
Official title: Reproducibility and Method Comparison of the Quo-Test™ A1C System and the Quo-Lab A1C Test and CLIA Waiver of the Quo-Test™ A1C System
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Keywords: Type I Diabetes
Type II Diabetes
HbA1C
Lead sponsor: Quotient Diagnostics Limited
Sponsor class: INDUSTRY
First posted: 2013-04-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From site's patient database

Brief summary: The Quo-Test A1C Analyzer and Reagent Test System (Quo-Test A1C System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from fingerstick or venous samples for point-of-care testing. The Quo-Test A1C System is indicated in the management and treatment of diabetes and for monitoring long term glycemic control by diabetics. It is for multiple patient use. Only auto-disabling, single use lancing devices should be used with this system.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years or over
* Able to read English
* Read, understood and signed the Informed Consent Form
* Agrees to participate and does not withdraw\\
* Either healthy (without diabetes) or has Type 1 or Type 2 diabetes

Exlcusion Criteria:

• Declines participation or withdraws before study completion

Primary outcomes:
measure: The objective is to conduct reproducibility testing using duplicates of each of 3 levels of HbA1C
timeFrame: 10 Days
Secondary outcomes:
measure: Obtain CLIA Waiver Status for the Quo-Test
timeFrame: 10 Days
Other outcomes:
Locations:
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Chaska
country: United States
facility: Ridgeview Research
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: AMCR Institute
name: Tim Bailey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ridgeview Research
name: Stephanie Svoboda, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Missouri-Columbia
name: Michael Gardner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07001761: Ultrasonographic Evaluation of Osteoarthritis.
Official title: Ultrasonographic Evaluation of Osteoarthritis. A Comparative Study to Conventional Radiography in Patients With Painful Knee.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Assessment of the effectiveness of ultrasonography in correlation to conventional imaging for the detection of the definite grading of knee osteoarthritis.

Detailed description: Assessment the effectiveness of ultrasonography in correlation to conventional imaging for the detection of the definite grading and the complication of knee osteoarthritis for patient complaining from knee pain coming to our radiology department for imaging with a clinical signs of knee osteoarthritis.

Eligibility criteria: Inclusion Criteria:

Age: above 30 years. Unilateral or bilateral knee joint affection. Symptomatic patient.

Exclusion Criteria:

* Any female patient in the child bearing period presented with Chronic inflammatory joint disease as Rheumatoid arthritis, SLE. Systemic diseases: Renal failure. Significant joint trauma or surgery.

Primary outcomes:
measure: The outcome for the study is to test the MUS score's ability to discern various degrees of knee OA, in comparison with plain radiography and the 'Knee injury and Osteoarthritis Outcome Score' (KOOS).
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
Clinical trial NCT06169761: Tongue Protrusion Assessment in Healthy Adult (FLEPI)
Official title: Assessment of Tongue Protrusion Motor Skills in Healthy Adult
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy
Keywords: Tongue
Motor skills
Protrusion
Strength
Fatigability
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprised healthy adults from Belgium, including both men and women aged 18 years and older, who meet all eligibility criteria.

Brief summary: This study aims to evaluate tongue protrusion motor skills in healthy adults and to assess the reliability of these measurements as well as their validity in relation to other motor functions (handgrip and respiratory muscles).

Detailed description: The tongue is an organ involved in multiple essential daily functions (such as eating, speaking, and breathing). Normative values exist for the motor skills of tongue elevation in individuals. However, data regarding protrusion are lacking. Yet, the protrusive strength of the tongue is of particular interest. Indeed a weak protrusive tongue strength may contribute to sleep apnea and swallowing disorders. Therefore, this study aims to collect normative and clinimetric (validity and reliability) data of tongue protrusion strength and endurance among healthy adults.

Eligibility criteria: Inclusion Criteria:

* Being 18 years of age or older

Exclusion Criteria:

* Eating disorder
* Dysphagia
* Cardiorespiratory disorder
* Previous or ongoing obstructive sleep apnea-hypopnea syndrome
* Neurological conditions (including neuromuscular disorders)
* Previous or ongoing cancer of the head or neck
* Pregnancy
* Any physical or mental condition that may affect the ability to consent

Primary outcomes:
measure: Tongue protrusion peak pressure
timeFrame: Measured two times: at baseline and after 2 to 4 weeks
measure: Tongue protrusion endurance
timeFrame: Measured two times: at baseline and after 2 to 4 weeks
Secondary outcomes:
measure: Tongue elevation peak pressure
timeFrame: Measured two times: at baseline and after 2 to 4 weeks
measure: Tongue elevation endurance
timeFrame: Measured two times: at baseline and after 2 to 4 weeks
measure: Tongue mobility restriction
timeFrame: Measured once at baseline
measure: Maximum Inspiratory and Expiratory Pressure
timeFrame: Measured once at baseline
measure: Handgrip Strength
timeFrame: Measured once at baseline
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: UCLouvain
Study officials:
References:
Clinical trial NCT00516061: Relationship of Peritoneal Solute Transport Rate With VEGF in Children Undergoing Peritoneal Dialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritoneal Dialysis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2007-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Vascular endothelial growth factor(VEGF) appears to play a central role in the process leading to peritoneal angiogenesis and increased level of VEGF may contribute to high peritoneal small-solute transport rate (PSTR) in continuous ambulatory peritoneal dialysis (CAPD) patients in adult. In children, lymphatic absorption of solute is greater than adult. VEGF-C is related to lymphogenesis, but its role in peritoneal solute transport rate is not known. In this study, we evaluated possible relationship between dialysate VEGF and VEGF-C levels and PSTR in children.

Detailed description: There was significant correlation between dialysate VEGF165 and VEGF-C levels and significant correlation was noted between dialysate VEGF165 and PSTR. Interestingly, dialysate VEGF-C levels had significant correlation with PSTR. High PSTR seems to be related to elevated VEGF-C and VEGF.

Eligibility criteria: Inclusion Criteria:

* chronic renal failure
* children
* peritoneal dialysis

Exclusion Criteria:

* acute illness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center, Sungkyunkwan University School of Medicine
name: Kyung Hoon Paik, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02065661: Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)
Official title: Product Validation Study of 2 New Devices, EZ-NG (RightSpot pH Indicator) and EZ-pH (RightLevel pH Indicator)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Obstruction
Colectomy
Bowel Surgeries
Lead sponsor: Florida Hospital Tampa Bay Division
Sponsor class: OTHER
First posted: 2014-02-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consented elective surgical candidates

Brief summary: EZ Holdco Inc. has developed two devices for the measurement of gastric content pH. The devices, EZ-NG and EZ-pH, rapidly check gastric pH by aspirating gastric contents into the device through a nasogastric (NG) tube and causing a color change in the device. The color change is then compared to the reference indicator on the device to determine a pH value of the aspirate. Currently there is no bedside rapid way to check gastric pH that protects the clinician from being exposed to the aspirate.

1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.
2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.


Eligibility criteria: Inclusion Criteria:

* Consented elective surgical patient

Exclusion Criteria:

-

Primary outcomes:
measure: 1. Primary Objective To assess the accuracy of the pH measurement of gastric fluid on the devices by comparing the reading on the 2 devices to a standard clinically approved pH probe.
timeFrame: 60 min
Secondary outcomes:
measure: 2. Secondary Objective To determine what percentage of time the EZ-NG - RightSpot pH indicator could have been used to determine proper placement of the NG tube when initially placed.
timeFrame: 60 min
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03070561: Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects
Official title: Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Peanut Allergy
Immunotherapy
Pharmacokinetics
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2017-03-03
Enrollment: 9
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, crossover, local pharmacokinetics study
Primary purpose: OTHER

Brief summary: Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

Detailed description: In this study, 15 non-peanut allergic children and adults will be enrolled. At three visits, each at least a day apart, the study product (dissolving film) containing approximately 60 mcg of the major peanut allergen (Ara h 2), equivalent to approximately 1000 mcg of peanut protein, will be placed in one of three areas: the sublingual space, affixed to the buccal mucosa, and in the vestibular space. Concentrations of Ara h2 in saliva collected at several locations over several time points in the mouth will be analyzed by ELISA.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 3 years and \<30 years.
* Able to give informed consent.
* English speaking with no language impairment
* Regularly consume a meal sized portion (approximately 5 grams) of peanut at least twice per month during the preceding 6 months

Exclusion Criteria:

* History of reaction to peanuts
* Major active medical problems of the oral cavity or use of medications that might change rates of salivation

Primary outcomes:
measure: Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement
timeFrame: 3 days
measure: Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement
timeFrame: 3 days
measure: Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Corinne Keet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03249961: How Many Days Would You Want to Practice a Skill to Achieve it?
Official title: How Many Days Would You Want to Practice a Skill to Achieve it?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motor Learning
Keywords: motor
transcranial direct current stimulation
transcranial magnetic stimulation
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Practice is required to improve your shot in basketball or to play a musical instrument. The learning of these motor skills can be further enhanced by non-invasively stimulating regions of the brain that control movements with electrical currents. These electric currents can strengthen or weaken connections of the brain, which consequently affects a person's ability to improve their performance on a skill. Non-invasive brain stimulation (NIBS) is widely applied in many disciplines of neuroscience research, and has potential therapeutic application. There are two specific types of NIBS that will be used in this research study: 1) Transcranial Direct Current Stimulation (tDCS), which applies very weak electrical currents via two rubber electrodes on the scalp, and 2) Transcranial Magnetic Stimulation (TMS), which applies magnetic pulses via a coil against the head, to stimulate regions of the brain. Both types of non-invasive brain stimulation (i.e., tDCS, and TMS) are well-tolerated, painless, and safe. The application of tDCS to brain regions that control movements, concurrently with practice of a skill, results in better skill performance, than practice alone with no tDCS. Therefore, in this study, we will be testing different types of brain stimulation and different amounts of practice.


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* prior history of neurological or psychiatric disease
* prior experience with the motor task used
* contraindications to TMS and TDCS (e.g., metal implants, history of seizures and headaches)
* musculoskeletal injury to upper limb
* drugs that interact with NIBS (e.g., antidepressants, antipsychotics, anticonvulsants)

Primary outcomes:
measure: Accuracy
timeFrame: Up to 8 days
measure: Speed
timeFrame: Up to 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
Study officials:
affiliation: Sunnybrook Research Institute
name: Joyce Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01258361: Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting
Official title: Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypovolemia
Keywords: preoperative fasting
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recruited during anesthesia consultations carried out before programmed gynecological or visceral surgeries.

Brief summary: The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.


Eligibility criteria: Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is ASA (American Society of Anesthesiologists) class I, II or III
* The patient has not been fasting for more than 6 hours at the time of inclusion
* The patient is schelduled for a gynecological or visceral surgery

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant
* The patient is breastfeeding
* The patient is ASA class IV
* The patient has insulin dependent diabetes
* The patient has a cardiac or respiratory dysfunction
* The patient has a heart rhythm disorder
* The patient has renal insufficiency with dialysis
* The patient is being treated with diuretics
* The patient has had a bowel preparation
* Emergency surgery
* Outpatient surgery

Primary outcomes:
measure: The presence / absence of a hypovolemia following preoperative fasting
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Laurent Muller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller L, Briere M, Bastide S, Roger C, Zoric L, Seni G, de La Coussaye JE, Ripart J, Lefrant JY. Preoperative fasting does not affect haemodynamic status: a prospective, non-inferiority, echocardiography study. Br J Anaesth. 2014 May;112(5):835-41. doi: 10.1093/bja/aet478. Epub 2014 Feb 3.
Clinical trial NCT06102161: Wedge Resection for Ground-glass Opacity-featured Lung Cancer (ECTOP-1020)
Official title: Wedge Resection for Ground-glass Opacity-featured Lung Cancer With Size Less Than 2cm and Consolidation-to-tumor Ratio Between 0.25 to 0.5: a Single-arm, Multi-center, Prospective, Confirmatory Phase III Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Lung Cancer
Wedge Resection
Ground-glass Opacity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a clinical trial from the Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1020. The goal of this clinical trial is to confirm the therapeutic effect of Wedge resection for ground-glass opacity-featured lung cancer with a size less than 2cm and a consolidation-to-tumor ratio between 0.25 to 0.5.


Eligibility criteria: Inclusion Criteria:

1. Patients who sign the informed consent form and are willing to complete the study according to the plan;
2. Aged from 18 to 80 years old;
3. ECOG equals 0 or 1;
4. Not receiving lung cancer surgery before;
5. Intraoperative or postoperative pathologic diagnosis of lung adenocarcinoma;
6. Single lung nodules with ground-glass dominant or pure ground-glass on CT, or multiple lung nodules with the major lesion being the aforementioned nodules;
7. The nodule has a consolidation-to-tumor ratio (CTR) between 0.25 and 0.5 (including 0.25 and 0.5), and the nodule size is less than or equal to 2 cm;
8. peripheral type of nodes, namely, nodes in the outer 1/3 of the lung field.
9. cT1N0M0 tumors;
10. Complete tumor resection by wedge resection as assessed by the surgeon;
11. Not receiving chemotherapy or radiotherapy before.

Exclusion Criteria:

1. Postoperative pathologic diagnosis of adenocarcinoma in situ or minimally invasive adenocarcinoma.
2. CTR is not between 0.25-0.5 or nodule size greater than 2 cm;
3. Cannot be completely resected by wedge resection;
4. Invasive lung adenocarcinoma or lung malignancy other than lung adenocarcinoma diagnosed cytologically or pathologically;
5. Receiving lung cancer surgery before;
6. Receiving radiotherapy or chemotherapy.

Primary outcomes:
measure: 5-year overall survival
timeFrame: 5 years
Secondary outcomes:
measure: 5-year recurrence-free survival
timeFrame: 5 years
measure: Postoperative lung function (FEV1)
timeFrame: 5 years
measure: Postoperative lung function
timeFrame: 5 years
measure: Sites of tumor recurrence and metastasis
timeFrame: 5 years
measure: Radical wedge resection (R0 resection) completion rate
timeFrame: 5 years
measure: Surgery-related complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: