louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02127528: Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care
Official title: Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care: Pharmacodynamic Evaluation and Impact.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ventilator-associated Pneumonia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-04-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pneumonia acquired in mechanically ventilated patients (PAVM)

Brief summary: this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact of these pharmacodynamic parameters on the clinical and microbiological VAP will be evaluated.


Eligibility criteria: Inclusion Criteria:

1. Use of mechanical ventilation for more than 48 hours
2. Clinical suspicion of ventilation-acquired pneumonia (VAP) defined by new radiological persisting infiltrate (or ARDS) AND one of the following features:

   purulent tracheal aspirates OR temperature ≥ 38.3°C OR leukocytosis\> 10 giga/L
3. High risk of multidrug-resistant bacteria, defined as either at least 6 days of mechanical ventilation OR antibiotic treatment in the previous 15 days
4. Implementation of a prior distal respiratory sample for microbiological diagnosis by bronchoalveolar lavage (BAL) OR distal sampling by protected catheter (PDP)
5. Age ≥ 18 years
6. Implementing a medical examination
7. Obtain the written consent of the patient, one of its relatives or trusted person previously designated or emergency clause.

Exclusion Criteria:

1. Pregnant woman
2. Expected death within 72 hours of diagnosis of VAP patient
3. Dialysis
4. No affiliation to a social security scheme (beneficiary or legal)
5. Contraindication to one of classes of molecules used antibiotics (β-lactam / Fluoroquinolones / Aminoglycosides), contained in the Summary of Product Characteristics for authorization on the market.

Primary outcomes:
measure: adequate antibiotics
timeFrame: 28 days
Secondary outcomes:
measure: Bacterial species
timeFrame: 28 days
measure: Distribution of the main pharmacodynamic parameters
timeFrame: 28 days
measure: Eradication of gram negative bacilli responsible for VAP
timeFrame: 28 days
measure: Death
timeFrame: 28 days
measure: Number of days alive without mechanical ventilation
timeFrame: 28 days
measure: Clinical recovery
timeFrame: 28 days
measure: Score of organ failure (SOFA)
timeFrame: 8 days
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: CH Victor Dupouy
state: Val d'Oise
Study officials:
References:
Clinical trial NCT01339728: Far-infrared Ray Effect on CV12 Acupoint
Official title: Far-infrared Ray Illuminates Area of CV12 Acupoint to Investigate the Correlation of Skin Temperature and Skin Blood Flow Between CV12 Acupoint and Palm Central Part of Right Hand
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reaction of Far Infrared Ray
Reaction of Skin Temperature
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-04-21
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the present study was to investigate the effect of far-infrared ray at CV12 acupoints area on the skin temperature and skin blood flow of palm central area of right hand, and the correlation between them.

Detailed description: The purpose of the present study was to investigate the effect of far-infrared ray at CV12 acupoints area (the center is CV12 acupoints and the diameter is 10 cm) on the skin temperature and skin blood flow of palm central area of right hand, and the correlation between them.

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers, male or female, ages between 20 and 40 years
* Neurological and physical examination without abnormal functions
* Far-infrared ray illumination without allergic reaction and contra- indication
* The participants were explained the objective of the study, agreed to accept the test and signed a letter of consent

Exclusion Criteria:

* People less than 20 years of age or more than 40 years
* Women in pregnant or lactating
* People with mental or behavioral anomalies could not follow the researchers
* People suffered from serious diseases such as myocardial infarction , heart failure, serious arrhythmia, hypertension, diabetes, autoimmune disease, chronic obstructive pulmonary diseases, and kidney failure, liver cirrhosis and cancer
* People suffered from limb edema and serious skin diseases
* People did not sign a letter of consent

Primary outcomes:
measure: far-infrared ray on CV12 acupoint area may increase the skin temperature
timeFrame: Each period was 20 min in duration
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Ching-Liang Hsieh, professor
role: STUDY_CHAIR
References:
Clinical trial NCT02856828: Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
Official title: Novel Use of an Enhanced Fluoroscopic Imaging Device to Reduce Radiation Exposure and Operative Time During Intramedullary Nailing of Hip Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Radiation Exposure
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 5
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 study is to evaluate the effectiveness of a novel digital image enhancement (DIE) technology in reducing the radiation exposure to both the patient and surgical staff during standard intramedullary nail placement for treatment of hip fractures. Secondarily, to evaluate whether the image quality and reproducibility of desired images can be improved with use of the DIE technology. Finally, to evaluate whether DIE technology reduces total operative time.


Eligibility criteria: Inclusion Criteria:

* closed hip fracture requiring intramedullary nailing

Exclusion Criteria:

* age \<18 years

Primary outcomes:
measure: Radiation Exposure to Patient During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
timeFrame: intraoperatively
measure: Radiation Exposure to Surgeon During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
timeFrame: intraoperatively
measure: Radiation Exposure to Scrub Tech During Intramedullary Nail Placement for Treatment of Hip Fractures as Measured by Dosimeter Badge
timeFrame: intraoperatively
Secondary outcomes:
measure: Image Quality and Reproducibility of Desired Images
timeFrame: intraoperatively
measure: Operative Time
timeFrame: intraoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
References:
Clinical trial NCT01591928: Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study
Official title: Heterotaxy Syndrome and Intestinal Rotation Abnormalities - A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heterotaxy Syndrome
Keywords: Pediatrics
Congenital heart disease
Heterotaxy syndrome
Intestinal malrotation
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All infants with heteterotaxy syndrome whose families provide written informed consent.

Brief summary: Infants with heterotaxy syndrome (HS) are born with an abnormal arrangement of organs along the right-left body axis. Abnormalities of intestinal rotation and fixation are commonly associated with HS. Malrotation is the most worrisome intestinal rotation abnormality (IRA). Advances in cardiac surgery have improved HS mortality such that there is increasing attention to IRA and their management. The objective of this research project is to prospectively observe a cohort of infants with HS and IRA and evaluate their long term outcomes. Specifically, the investigators would like to determine what is the natural history of asymptomatic IRA in patients with HS and what is the morbidity and mortality secondary to an elective Ladd procedure for asymptomatic IRA in a population with HS? The investigators plan a prospective, multi-center, observational study to follow this complicated group of patients. This will be a web-based database collected from major cardiac tertiary care centers in both Canada and the United States. Patients with HS will be recruited by their primary site and clinical data will be collected by their primary site prospectively throughout childhood until they are at least five years of age. This patient population will be followed by their own clinical care givers; this is not an interventional study. No additional clinic visits will be required and the patients will not have to be contacted. Patient medical records will be accessed by a member of the study team at the primary site at least once per year or more frequently if interventions are required or complications develop.


Eligibility criteria: Inclusion Criteria:

* All infants less than or equal to six months of age with a new diagnosis of heterotaxy syndrome

Exclusion Criteria:

Primary outcomes:
measure: Midgut volvulus
timeFrame: First year of life
Secondary outcomes:
measure: Morbidity secondary to a prophylactic Ladd procedure
timeFrame: Post Ladd procedure
measure: Mortality secondary to a prophylactic Ladd procedure
timeFrame: Within one month of Ladd procedure
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Lindsay Ryerson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05010928: Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
Official title: Using Tea-based Mouthwash Relieve Stomatitis and Oral Ulcers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stomatitis
Keywords: Stomatitis; oral ulcers; oral mucosa; tea; mouthwash
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to use a tea-based mouthwash to relieve pain and discomfort in patients with stomatitis and ulcers.

Detailed description: The objective of this study is to use tea as a base, supplemented with licorice to reduce bitterness and astringency, to make mouthwash, and use tea's antioxidant and anti-inflammatory properties to relieve the pain and discomfort of stomatitis and ulcer patients. This study will observe the difference between saliva and oral mucosal cells before and after treatment, to find the mechanism of effective treatment of stomatitis.

Eligibility criteria: Inclusion Criteria:

age over 20 years old, male or female

Exclusion Criteria:

patients with oral cavity cancer, oropharyngeal cancer, and active bacterial infection.

Primary outcomes:
measure: Xerostomia questionnaire (XQ)
timeFrame: 4 weeks
measure: Xerostomia Inventory (XI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Rate of oral mucosa cells with angiotensin-converting enzyme 2 (ACE2) staining (+)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chiayi City
country: Taiwan
facility: Chiayi chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT04545528: The Impact of Nutritional Service in the Stone Clinic on the Patient Urine Collection Results
Official title: The Impact of Nutritional Service in the Stone Clinic on the Patient Urine
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Kidney Stone
Kidney Calculi
Keywords: kidney stone
kidney Caliculi
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2020-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients18 yo and older referred to out kidney stone clinic

Brief summary: Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. Life style and dietary changes have a cardinal part in kidney stone prevention. Therefore it was only natural to determine the impact of the addition of a nutritionist to a stone clinic run by a urologist and a nephrologist.

Detailed description: Kidney stone disease has become a common phenomenon in the US and Europe with a growing incidence of about 10%. A history of kidney stone disease has also been connected to cardiovascular and renal insufficiency events to a point that kidney stones is looked at today as a systemic predictor of hypertension, cardiovascular disease and more.

Seeing the importance of these risk factors we initiated a stone clinic for our kidney stone patients several years ago run jointly by a urologist and a nephrologist. Seeing that life style and dietary changes have a cardinal part in kidney stone prevention, it was only natural to determine the impact of the addition of a nutritionist to a stone clinic run by a urologist and a nephrologist on our patient parameters.

Eligibility criteria: Inclusion Criteria:

* 18 yo and older
* 2 kidneys
* Kidney or ureteric stone treated surgically or conservatively

Exclusion Criteria:

* Single kidney
* Aberrant kidney anatomy

Primary outcomes:
measure: 24h Urine collection results
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Weight
timeFrame: Through study completion, an average of 1 year
measure: Height
timeFrame: Through study completion, an average of 1 year
measure: BMI
timeFrame: Through study completion, an average of 1 year
measure: Creatinin in mg/dl
timeFrame: Through study completion, an average of 1 year
measure: Calcium in mg/dl
timeFrame: Through study completion, an average of 1 year
measure: sodium in mg/dl
timeFrame: Through study completion, an average of 1 year
measure: potassium in mg/dl
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Lady Davis Medical Center
Study officials:
References:
Clinical trial NCT04012528: ERAS and Pediatric Scoliosis Surgery
Official title: Assesment of Enhanced Recovery After Pediatric Idiopathic Scoliosis Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scoliosis
Keywords: Pediatric
Surgery
Rehabilitation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 150
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chidren and teenager admitted for scoliosis surgery

Brief summary: The aim of this study is to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

Detailed description: Enhanced recovery after surgery (ERAS) is a multimodal approach focused on reducing the stress response and associated physiologic changes related to surgery. Over the past 20 years, ERAS programs have been found to result in reduced lenght of stay and complications in adult patients. Data in pediatric population remains very scarce.Therefore this study was designed to compare the outcomes after scoliosis surgery before and after ERAS (enhanced recovery after surgery) program inplementation in children and teenager.

Eligibility criteria: Inclusion criteria:

* patient with age \< 18 years
* patient scheduled for scoliosis surgery

Exclusion criteria:

* patient with age \> 18years
* patient with medical follow up by pediatric chronic pain departement

Primary outcomes:
measure: Postoperative length of hospital stay
timeFrame: up to 4 weeks after surgery
Secondary outcomes:
measure: Number of Antalgics consumption
timeFrame: up to 15 days after surgery
measure: Time to oral diet tolerance
timeFrame: up to 15 days after surgery
measure: Time to first bowel motion
timeFrame: up to 15 days after surgery
measure: Time to first verticalization
timeFrame: up to 15 days after surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Chrystelle CS SOLA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05312528: Evaluation of New Biomarkers in Stage 3 and 4 Endometriosis
Official title: Diagnostic Value of Annexin V, sVCAM-1, sICAM-1, Vascular Endothelial Growth Factor, TNF Alpha and Interleukin-6 in Ovarian and Deep Infiltrating Endometriosis, the Changes of These Markers in the Postoperative Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometriosis
Lead sponsor: Bagcilar Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-04-05
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stage III and IV endometriosis patients aged 18-50 years requiring surgery for chronic pelvic pain or suspected malignancy

Brief summary: The diagnostic value of Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and Proinflammatory cytokines (TNF-a and interleukin-6) in ovarian endometriosis and deep infiltrating endometriosis, their levels in organ-specific involvement, their relationship with symptoms, and the changes of these markers in the postoperative period will be evaluated.

Detailed description: Serum Annexin V, sVCAM-1, sICAM-1, vascular endothelial growth factor and proinflammatory cytokines (TNF-a and interleukin-6) values were studied by taking blood samples from all patients before and three months after the operation.

Eligibility criteria: Inclusion Criteria:

1. Stage III and IV endometriosis patients requiring surgery due to chronic pelvic pain or suspected malignancy

Exclusion Criteria:

1. Malignant disease
2. Ovarian failure
3. Acute pelvic inflammatory disease
4. Smokers
5. Pregnancy
6. Chronic autoimmune disease

Primary outcomes:
measure: Diagnostic value of serum Annexin V in endometriosis
timeFrame: Up to 4 months
measure: Diagnostic value of serum sVCAM-1 in endometriosis
timeFrame: Up to 4 months
measure: Diagnostic value of serum sICAM-1 in endometriosis
timeFrame: Up to 4 months
measure: Diagnostic value of serum Vascular Endothelial Growth Factor in endometriosis
timeFrame: Up to 4 months
measure: Diagnostic value of serum TNF-alpha in endometriosis
timeFrame: Up to 4 months
measure: Diagnostic value of serum Interleukin-6 in endometriosis
timeFrame: Up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bagcilar Teaching and Research Hospital
state: Bagcilar
Study officials:
affiliation: Bagcilar Training and Research Hospital
name: Evrim Ebru Kovalak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vodolazkaia A, El-Aalamat Y, Popovic D, Mihalyi A, Bossuyt X, Kyama CM, Fassbender A, Bokor A, Schols D, Huskens D, Meuleman C, Peeraer K, Tomassetti C, Gevaert O, Waelkens E, Kasran A, De Moor B, D'Hooghe TM. Evaluation of a panel of 28 biomarkers for the non-invasive diagnosis of endometriosis. Hum Reprod. 2012 Sep;27(9):2698-711. doi: 10.1093/humrep/des234. Epub 2012 Jun 26.
Clinical trial NCT02024828: Testing Four Feeding Approaches to Oral Feeding in Preterm Infants
Official title: Feeding Readiness in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Keywords: Infant feeding
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Virginia Commonwealth University
First posted: 2013-12-31
Enrollment: 109
Sex: ALL
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to test the effect of four randomly assigned approaches to oral feeding transition on feeding outcomes in preterm infants.

Detailed description: The study is completed.

Eligibility criteria: Inclusion Criteria:

* 1) the infant's gestational age at birth was less than 32 weeks; 2) the infant was receiving enteral feedings every three hours; 3) the infant was able medically to feed orally by 32 weeks post-menstrual age (PMA); and 3) the parents gave consent for the infant's participation.

Exclusion Criteria:

* 1) they were unable to begin oral feeding at 32 weeks PMA due to gastrointestinal, craniofacial, cardiovascular, neuromuscular, and/or genetic defects; 2) had surgical necrotizing enterocolitis; or 3) needed ventilator support, including nasal continuous positive airway pressure (CPAP), beyond 32 weeks PMA. Infants receiving oxygen by cannula were included.

Primary outcomes:
measure: Feeding Performance
timeFrame: One oral feeding a day for 14 days
Secondary outcomes:
measure: Clinical outcomes
timeFrame: Participants will be followed for the duration of the hospital stay, an expected average from starting oral feedings of 3 weeks
measure: Post-discharge feeding
timeFrame: 2 weeks after discharge
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: CCHMC
state: Ohio
Study officials:
References:
citation: Alberts JR, Pickler RH. Evolution and development of dual ingestion systems in mammals: notes on a new thesis and its clinical implications. Int J Pediatr. 2012;2012:730673. doi: 10.1155/2012/730673. Epub 2012 Sep 18.
citation: Pickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.
citation: Pickler RH, Reyna BA, Griffin JB, Lewis M, Thompson AM. Changes in Oral Feeding in Preterm Infants Two Weeks After Hospital Discharge. Newborn Infant Nurs Rev. 2012 Dec 1;12(4):202-206. doi: 10.1053/j.nainr.2012.09.012. Epub 2012 Nov 15.
citation: Pickler RH, McGrath JM, Reyna BA, Tubbs-Cooley HL, Best AM, Lewis M, Cone S, Wetzel PA. Effects of the neonatal intensive care unit environment on preterm infant oral feeding. Res Rep Neonatol. 2013 Apr 3;2013(3):15-20. doi: 10.2147/RRN.S41280.