louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03298347: Caffeine for Preterm Infants With Apnea of Prematurity(AOP)
Official title: Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caffeine
Apnea of Prematurity
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce the intubation rate effectively is a challenge for neonatologists.

Detailed description: Less evidences about more dose of caffein used in preterm infants.

Eligibility criteria: Inclusion Criteria:

* gestational age less than 32 weeks;
* appear AOP;
* parents'consents are obtained.

Exclusion Criteria:

* major congenital abnormalities;
* Parents' rejection

Primary outcomes:
measure: the rate of AOP
timeFrame: within 100 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, MD;PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05521347: Caffeine Supplementation Improves the Cognitive Abilities and Shooting Performance of Trained E-sports Players
Official title: Graduate Program in Department of Exercise Health Science, National Taiwan University of Sport
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Placebo
Keywords: caffeine
reaction time
Lead sponsor: National Taiwan Sport University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 9
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Purpose: investigators explored the effect of 3 mg/kg of caffeine supplementation on the cognitive ability and shooting performance of trained e-sports players. Methods: investigators recruited nine e-sports players who had received professional training in e-sports and had won at least eighth place in national-level e-sports shooting competitions. After performing three to five familiarization tests, investigators employed a randomized crossover design to divide participants into a caffeine trial (CAF) and a placebo trial (PL). The CAF group took capsules with 3 mg/kg of caffeine, whereas the PL group took a placebo capsule. After a 1-h rest, the Stroop task, visual search ability test, and the shooting ability test were conducted.


Eligibility criteria: Inclusion Criteria:

* had experience with national competitions and regularly underwent training in first-person shooters

Exclusion Criteria:

* no experience with national competitions and regularly underwent training in first-person shooters
* have any diseases affecting the heart, bones, and joints or diseases that preclude exercise

Primary outcomes:
measure: Stroop task
timeFrame: 1 hour after intervention
measure: visual search test
timeFrame: 1 hour after intervention
Secondary outcomes:
measure: aim trainer
timeFrame: 1 hour after intervention
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: National Taiwan University of Sport
Study officials:
References:
Clinical trial NCT05162547: Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay
Official title: Multi-Center Clinical Performance Evaluation of the NeuMoDx™ FluA/FluB/RSV/Severe Acute Respiratory Syndrome-CoV-2 Assay on the NeuMoDx™ Molecular Systems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Disease
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2021-12-17
Enrollment: 2383
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals presenting with influenza-like illness from all age groups

Brief summary: To demonstrate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the NeuMoDx Systems by determining clinical sensitivity and specificity of the Assay.

Detailed description: To evaluate the clinical performance of the NeuMoDx™ FluA/FluB/RSV/SARS-CoV-2 Assay on the on the NeuMoDx™ 288 and 96 Molecular Systems, collectively referred to as NeuMoDx Systems. The results of this study will be used to support regulatory registration and product release in the US, Europe and other markets.

Eligibility criteria: Inclusion Criteria:

* Fresh specimens shall be collected from all comers across the study duration
* Collected from individuals of any age presenting with influenza-like illness (ILI)
* Nasopharyngeal (NP) swab specimen obtained using a flexible mini-tip flocked swab and collected into 3 mL Copan® Universal Transport Media (UTM) \[Cat. No.305c\] or Beckton Dickinson (BD™) Universal Viral Transport (UVT) \[Cat. No. 220531\]
* Minimum volume for residual specimen approximately 2 mL
* Fresh specimens to be tested within 3 days of collection.
* Fresh specimens to be stored under the recommended stability conditions (2-8°C).

Exclusion Criteria:

* Required information unable to be obtained from associated medical chart.
* Specimens not fitting criteria outlined above.

Primary outcomes:
measure: Positive Percentage Agreement
timeFrame: 6 months
Secondary outcomes:
measure: Negative Percentage Agreement
timeFrame: 6 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN Gaithersburg, Inc
Study officials:
affiliation: QIAGEN Gaithersburg, Inc
name: Sarah Johnson
role: STUDY_DIRECTOR
References:
Clinical trial NCT05873647: Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by EIT in Patients With ARDS
Official title: Effect of Inhaled Nitric Oxide on Pulmonary Ventilation/Perfusion Ratio Assessed by Electrical Impedance Tomography in Patients With Acute Respiratory Distress Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 30
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: Patients with ARDS

Brief summary: Electrical impedance tomography was used to monitor changes in pulmonary perfusion distribution and V/Q ratio before and after iNO in patients with acute respiratory distress syndrome to investigate the factors predicting iNO reactivity and the physiological mechanism underlying changes in oxygenation.


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 18 years;
2. Patients are intubated and mechanically ventilated.

Exclusion Criteria:

1. EIT contraindications such as chest wound dressing, pacemaker installation, defibrillator, etc;
2. With a history of cerebral hemorrhage in the past half year, as well as bleeding in any site of the body;
3. Pneumothorax;
4. Medium or massive pleural effusion;
5. Refractory shock;
6. Pregnant
7. With chronic kidney disease
8. Atrial fibrillation or other malignant arrhythmia leads to a decrease in cardiac output;
9. Failure to sign informed consent

Primary outcomes:
measure: Lung ventilation/perfusion ration
timeFrame: 3 hours
Secondary outcomes:
measure: Lung perfusion distribution
timeFrame: 30minutes and 3 hours
measure: Shunting
timeFrame: 30minutes and 3 hours
measure: Dead space
timeFrame: 30minutes and 3 hours
measure: Oxygenation index
timeFrame: 30minutes and 3 hours
measure: Arterial partial pressure of carbon dioxide (PaCO2)
timeFrame: 30minutes and 3 hours
measure: Static respiratory compliance (Crs)
timeFrame: 30minutes and 3 hours
measure: Cardiac output
timeFrame: 30minutes and 3 hours
measure: Right ventricular function
timeFrame: 30minutes and 3 hours
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hongling Zhang
state: Hubei
Study officials:
References:
Clinical trial NCT06241547: PONV Prevention Via Percutaneous Nerve Electrical Stimulation on PC6
Official title: Perioperative Percutaneous Electrical Nerve Stimulation Via a Wearable Equipment on Postoperative Nausea and Vomiting（PONV） in Patients Undergoing Laparoscopy Abdominal Surgery: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.

Detailed description: Introduction: This study aims to certify the effectiveness of percutaneous electrical nerve stimulation at Pericardium 6 (PC6) via a wearable equipment during perioperative period on preventing postoperative nausea and vomiting.

Method and analysis: A total of approximately 302 patients undergoing elective laparoscopic surgery will be enrolled. Participants will be randomly assigned to either a electrical stimulation group or a placebo group, with computer-generated randomization and concealed allocation using sealed envelopes. The electrical stimulation group will receive PC point electrical stimulation 30 minutes before surgery until 24 hours postoperatively, while the placebo group will wear a wristband without stimulation. The primary outcome will be the incidence of postoperative nausea and vomiting, with secondary outcomes including the incidence of nausea and vomiting within 24 hours after surgery, gastrointestinal and hemodynamic indices, postoperative recovery, hospital stay and cost, and complications.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18-65 years;
2. Patients undergoing elective laparoscopic surgery;
3. American Society of Anaesthesiologists(ASA) Grade 1 to 3;
4. Anesthesia: General Anesthesia, Tracheal Intubation;
5. BMI: ≥18, \<28;
6. Gender: female
7. Patients or their family members are able to comprehend the study protocol and are willing to participate in this research by providing written informed consent.

Exclusion Criteria:

1. There are incisions or scars in the wearing position of the device;
2. There is a local infection in the wearing position of the device;
3. upper extremity nerve injury;
4. history of spinal cord surgery;
5. Participated in other clinical trials within 4 weeks;
6. suffering from severe central nervous system disease or mental disorder;
7. Patients need to return to the ICU after surgery.

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting(PONV)
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT05777447: International Multicenter Mycotic Aneurysm Aorto-iliac Study
Official title: Long Term Results of Aorto-iliac Mycotic Aneurysms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mycotic Aneurysm
Aortic Diseases
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 40
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: All patients undergoing surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction at the participating centers.

Brief summary: The term mycotic aneurysm (MA) is commonly used to describe all infected aneurysms. Although MAs are believed to occur uncommonly, the true incidence is difficult to determine and is probably underestimated since MAs can be asymptomatic and are diagnosed only at autopsy. In an autoptic study, mycotic aortic aneurysms (MAAs) were reported in 3.3% of all detected aneurysms. The incidence of infected aneurysms of the aorta and iliac arteries ranges from 0.6% to 1.3%.

A recent literature review of the management of MAAs showed that therapeutic strategies are multiple, including open surgical repair (OSR) in the majority of cases, endovascular aortic repair (EVAR), which increased over the last decade, and medical treatment alone for patients unfit for any aortic repair in a very limited part. Following the unfavorable prognosis towards rupture and since the medical treatment alone in mycotic aneurysms has shown mortality of almost 100%, surgical treatment is generally the preferred option.

Surgical treatment includes both open and endovascular surgery. The latter is less invasive than conventional surgery but does not involve resection of the infected tissue and is therefore associated with an increased risk of sepsis and prosthesis infection. The gold standard is still open surgery, including extra-anatomic reconstruction and in situ repair, with different type of vascular graft.

This is a multicenter retrospective observational study. It will examine all patients undergoing surgical treatment of mycotic aortic-iliac aneurysms and in situ reconstruction at the participating centers.


Eligibility criteria: Inclusion Criteria:

* primary mycotic aorto-iliac aneurysm who underwent in situ repair

Exclusion Criteria:

* patient with vascular graft infections;
* patient with secondary aorto-enteric fistula.

Primary outcomes:
measure: Early mortality
timeFrame: Mortality within 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT02335047: Investigation of the Putative Correlation Between Involuntary Psoas Activity During Passive Flexion of the Trunk at the Hips
Official title: The Putative Correlation Between Impaired Hip Flexor Passivity and Common Lower Back Pain: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Back Pain
Keywords: reliability
clinical test
physical therapy
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Passive flexion of the trunk (relative to the legs) may be accompanied by contraction of the psoas muscles, even when the subject has been told not to contract any muscles. The psoas contraction is involuntary and cannot be controlled by the subject. This lack of passivity might be concomitant with lower back pain: the impairment may be present when lower back pain is present and/or absent when lower back pain is absent.

The study's primary objective is thus to determine the sensitivity and/or specificity of a clinical test for impaired hip flexor passivity in cases of lower back pain during passive flexion of the trunk (from the supine position,).

The secondary objective is to show that a negative test (after administration of correcting measures) is correlated with a decrease in pain (i.e. pain intensity and the functional repercussions of pain).


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 30
* Social security coverage
* Ability to understand the study's objectives, procedures and risks and to provide informed, written consent
* Having been informed about the results of the prior clinical examination.

Exclusion Criteria:

* Past or concomitant infectious or cancerous diseases of the spine
* Vertebral osteosynthesis
* Acute neck or arm pain (recurrent dislocations of the glenohumeral joint, trauma in the previous 12 months, etc.)
* Lower back pain with irradiation of pain below the buttocks
* Known specific lower back pain or pain for which a differential diagnosis suggests an inflammatory, traumatic, cancerous or infectious cause
* Subjects under legal guardianship
* Known pregnancy
* Simultaneous participation in another biomedical research study of a drug or medical device.

Primary outcomes:
measure: Qualitative evaluation of impaired psoas muscle passivity during passive flexion of the trunk at the hips (while sitting).
timeFrame: Visit 1 (Day 0)
Secondary outcomes:
measure: - A visual analog scale for pain
timeFrame: - Visit 0 (Day 0: inclusion visit)
Other outcomes:
Locations:
Study officials:
affiliation: Les Hôpitaux universitaires de Strasbourg
name: Mutter Catherine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03788447: Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia
Official title: Effect of Pneumoperitoneum on Remifentanil Requirements in the Surgical Pleth Index-guided Analgesia for Laparoscopic Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2018-12-27
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to investigate the effect of pneumoperitoneum on remifentanil requirements in the surgical pleth index-guided analgesia for laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

* atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Primary outcomes:
measure: total dose of remifentanil
timeFrame: through study completion, an average of 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
state: Seoul
Study officials:
References:
Clinical trial NCT05916547: Safety and Efficacy of P-ESWL and ERCP
Official title: Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy and Endoscopic Retrograde Cholangiopancreatography for Pancreatic Stones
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Duct Stone
Keywords: Pancreatic Duct Stone
Pancreatic extracorporeal shock wave lithotripsy
Safety
Efficacy
endoscopic retrograde cholangiopancreatography
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 2071
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in Changhai Hospital from 2011.02.01 to 2018.06.30.

Brief summary: To determine the types, incidence and risk factors of adverse events after pancreatic extracorporeal shock wave lithotripsy (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP), define the grading criteria of adverse events after P-ESWL and ERCP, and analyze the efficacy of P-ESWL and ERCP, which will provide evidence-based medical evidence to guide physicians' clinical practice.

Detailed description: Currently, pancreatic extracorporeal shock wave lithotripsy (P-ESWL) and endoscopic retrograde cholangiopancreatography (ERCP) has become the preferred treatment for pancreatic duct stones. Although some studies had confirmed the safety and efficacy of P-ESWL and ERCP, the sample size were small and the follow-up period were short. Therefore, investigators designed this study with a large sample and a long follow-up period to clarify the efficacy and safety of P-ESWL and ERCP, so as to guide clinical work, standardize the diagnosis and treatment process of adverse events.

Eligibility criteria: Inclusion Criteria:

* Patients hospitalized in Changhai Hospital from 2011.03.01 to 2018.06.30.
* Painful patients with chronic pancreatitis.
* Patients who completed pancreatic extracorporeal shock wave lithotripsy.

Exclusion Criteria:

* Patients who diagnosed pancreatic cancer within 2 years after diagnosing chronic pancreatitis.
* Patients who refused to participate in the study.

Primary outcomes:
measure: the incidence of post-ESWL adverse events
timeFrame: 1 months
Secondary outcomes:
measure: the rate of pancreatic duct clearance
timeFrame: 1 week
measure: Pain relief of patients after P-ESWL and ERCP
timeFrame: more than 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Liang-hao Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li BR, Liao Z, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hao JF, Jiang YY, Hu LH, Li ZS. Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. Endoscopy. 2014 Dec;46(12):1092-100. doi: 10.1055/s-0034-1377753. Epub 2014 Sep 24.