louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04245891: Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section
Official title: Neonatal Evaluation of Norepinephrine Infusion in Spinal Anesthesia for Cesarean Section
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Caesarean Section;Stillbirth
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 265
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women over 18 years of age who need a caesarean section

Brief summary: This retrospective study aims to evaluate the fate of children born by cesarean section under spinal anesthesia with or without norepinephrine as vasopressor support for anesthesia. The main objective is to compare the initial Apgar score. The records of patients who received norepinephrine are compared to those without norepinephrine. To limit the biases of this type of study, the investigators will apply a propensity score that will include as a variable: age, ASA score, comorbidity, urgency. The patients analysed correspond to the period 2016-2017.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* Spinal Anesthesia for Cesarean Section

Exclusion Criteria:

* sub epidural cesarean section
* contraindication to spinal anesthesia (allergy, severe heart disease, coagulopathy)

Primary outcomes:
measure: lactate level
timeFrame: Just after the birth of the newborn baby
Secondary outcomes:
measure: APGAR Score
timeFrame: 1, 5 and 10 minutes after birth
measure: Umbilical Cord arterial PH
timeFrame: Just after the birth
measure: Umbilical Cord venous PH
timeFrame: Just after the birth
measure: maternal arterial tension during cesarean section
timeFrame: 0, 5,10,15, 20 25, 30,35,40 minutes after spinal anesthesia
measure: incidences of mother nausea and vomiting
timeFrame: from beginning to cesarean section end
measure: use of vasopressors
timeFrame: from beginning to cesarean section end
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01722591: Safety and Efficacy Study of the Cardiapex Percutaneous Trans-apical Access and Closure System
Official title: A Prospective, Multicenter, Uncontrolled Study to Evaluate the Safety and Efficacy of the Cardiapex Percutaneous Trans-apical Access and Closure System
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Transapical Transcatheter Aortic Valve Implantation
Lead sponsor: Cardiapex Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-07
Enrollment: 38
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A prospective, multicenter, uncontrolled study to evaluate the safety and efficacy of the Cardiapex percutaneous trans-apical access and closure system. The Cardiapex device intended for percutaneous access and closure of the left ventricular apex in conjunction with transapical Transcatheter Aortic Valve Implantation (TAVI).


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for transapical TAVI
* Patient ≥ 70 years of age
* Patient able to give informed written consent
* Patient able to attend follow up examinations

Exclusion Criteria:

* Scheduled concomitant non-TAVI cardiac procedure
* Patient with Left Ventricular Ejection Fraction (LVEF) \< 30% at time of enrollment
* Patient with known apical infarcted area
* Patient with a distinct large vessel right at the anatomical apex9 (based on pre-operative coronary angiography
* Patients with known lung tissue surrounding the apex and possibly interfering with the in-out puncture (based on preoperative gated CT assessment
* Patient with contra-indications to transapical TAVI
* Patient's inability to tolerate or comply with normal post-surgical drug regimen
* Patient's inability to comply with required follow-ups, including echocardiography
* Patient participation in other clinical trials within previous month

Primary outcomes:
measure: Successful performance of percutaneous transapical TAVI defined as: "Successful percutaneous transapical access and deployment of a single prosthetic heart valve"
timeFrame: Outcome measure assessed during the TAVI surgical procedure - an average of 3 hours
Secondary outcomes:
measure: ≤30 day apical bleeding requiring surgical intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Clinic
city: Hamburg
country: Germany
facility: Hamburg University Heart Center
Study officials:
References:
Clinical trial NCT00863291: A Double-Blind Study of Buprenorphine Treatment of Acute Suicidality
Official title: Phase 3 Study of the Effects of Buprenophine as Add-on Treatment to Antidepressants in Treating Acutely Suicidal Depressed Inpatients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Depression
Suicidal Ideation
Suicidal Action
Keywords: Depression
suicidality
buprenorphine
Lead sponsor: Abarbanel Mental Health Center
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Israel
First posted: 2009-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The acutely suicidal patient presents a complex and dangerous clinical dilemma. Many suicidal patients receive antidepressant medications, but the onset of action of these medications is at least three weeks, and despite their established antidepressant effect, they have not shown a clear anti-suicidal benefit. Psychoanalysts hypothesized that depression (often leading to suicidality) shares important characteristics with the psychological sequellae of object loss and separation distress. Endogenous opioids (endorphines) have been implicated in mediating social bonding and separation distress in mammals. Anecdotal evidence and several clinical studies found the mixed opioid agonist-antagonist buprenorphine to be an effective antidepressant with a rapid onset of action. It is therefore hypothesized that buprenorphine may be a novel and quick-acting treatment for acute suicidality, especially in the context of depression. The proposed double-blind study will examine the effect of buprenorphine on acutely suicidal inpatients. Depression, suicidality, and overall functioning will be assessed before, during and after a two-week buprenorphine/placebo trial. A small subgroup of patients will also be treated with short-term psychoanalytic psychotherapy throughout the study period. It is hypothesized that subjects who receive the active drug will show rapid improvements in objective and subjective measures of suicidality and depression.


Eligibility criteria: Inclusion Criteria:

* depression

Exclusion Criteria:

* substance or alcohol abuse
* psychosis

Primary outcomes:
measure: Reduction in suicidality as expressed by the score on the Beck Suicidal Ideation Scale
timeFrame: 2 weeks
Secondary outcomes:
measure: Reduction in psychache as measured by the OMMP
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bat-Yam
country: Israel
facility: Abarbanel MHC
Study officials:
affiliation: Haifa University, Israel
name: Yoram Yovel, MD, PHD
role: STUDY_CHAIR
References:
citation: Panksepp J. Neuroscience. Feeling the pain of social loss. Science. 2003 Oct 10;302(5643):237-9. doi: 10.1126/science.1091062.
Clinical trial NCT03503591: Study of the Hummingbird TTS™ Tympanostomy Tube System
Official title: Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otitis Media
Keywords: tympanostomy
myringotomy
otitis media
ear tubes
ear infection
Lead sponsor: Preceptis Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 109
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Children 6 months through 5 years of age, who are candidates for placement of VT.

Brief summary: The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.

Detailed description: The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.

Eligibility criteria: Inclusion Criteria:

* Age 6 months through 5 years of age
* Candidates for ventilation tube placement
* H-TTS used under moderate sedation and local anesthetic

Primary outcomes:
measure: Percentage of Procedures Converted From Sedation to General Anesthesia
timeFrame: Intra-operative
measure: Rate of Intra-operative Adverse Events
timeFrame: Intra-operative
measure: Rate of Adverse Events Through Discharge
timeFrame: Through discharge, estimated to be approximately 90 minutes post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Cloud
country: United States
facility: St. Cloud Ear, Nose & Throat
state: Minnesota
Study officials:
References:
Clinical trial NCT05203991: Avascular Bone Necrosis in Sickle Cell Disease: a Pediatric Study.
Official title: Explorative Study on Occult Avascular Osteonecrosis in a Pediatric Patients Cohort With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Avascular necrosis
Lead sponsor: San Luigi Gonzaga Hospital
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 32
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sickle cell pediatric patients followed in consultation in Microcitemie Centre within the framework of their sickle cell disease at San Luigi Gonzaga Hospital, Orbassano (Turin), Italy

Brief summary: Avascular necrosis (AVN) is a serious complication of sickle cell disease, especially in pediatric patients where the prevalence is between 3% and 8% and are more frequent in patients with multiple vaso-occlusive crisis (VOC). The prevalence of AVN is usually made by a study of the hip through radiography, whereas other possible sites of ischemic infarcts are evaluated only in case of specific symptoms. In addition, bone infarcts may be the trigger for additional VOC.

In this study, we want to investigate the presence of possible bone lesions even in asymptomatic or paucisymptomatic children.

This is a prospective interventional and monocentric study whose objective is to describe the prevalence of osteonecrosis in children with sickle cell disease in Italy


Eligibility criteria: Inclusion Criteria:

* Female or male patients diagnosed with sickle cell anemia (HbSS, HbS/β0, HbS/β+, HbSC) with or without known avascular lesions
* Age ≥ 7 and \< 18 years at the moment of signed consent
* Written informed consent/assent, according to local guidelines, signed by patient and/or guidelines, signed by the patient and/or at least one parent or legal guardian

Exclusion Criteria:

* - Any contraindication to perform Nuclear Magnetic Resonance Magnetic Resonance Imaging (MRI)
* Inability to obtain informed consent/assent

Primary outcomes:
measure: Calculate the prevalence of unknown osteonecrosis
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Orbassano
country: Italy
facility: AOU San Luigi Gonzaga
state: Torino
Study officials:
References:
Clinical trial NCT06597591: Virtual Reality Training for Inhibitory Control in Neurocognitive Disorders
Official title: Acceptability of a VR-based Training for Inhibitory Control in Subjects With Neurocognitive Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Disorder
Keywords: inhibitory control
serious game
virtual reality
cognitive disorder
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 48
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pseudo-randomisation (controlling for demographic and clinical features, and previous VR experience)
Primary purpose: OTHER

Brief summary: Executive function disorders, such as inhibitory control (IC) difficulties, are very common in older adults with neurocognitive disorders (NCD). Management of these disorders is possible using traditional tools and tools based on new technologies, such as serious games and virtual reality (VR). However, today, few immersive tools exist that are specifically focused on IC training. The present study aims to evaluate the acceptability of an immersive application focused on IC in 48 patients with neurocognitive disorders. Participants that will test either an immersive (VR-headset) or a non-immersive (tablet) version of the application for 4 weeks, twice a week, and fill-in acceptability related questionnaires before, during and after the end of the intervention.


Eligibility criteria: Inclusion Criteria:

1. consulting the Nice hospital Memory Center
2. diagnosis of Mild Neurocognitve Disorder or slight major neurocognitive disorder (DSM V)
3. 60 years old or more
4. presence of deficits in inhibitory control as assessed by the Frontal Assessment Battery
5. fluent in French
6. able to understand the informed consent form and voluntarily consents to participate

Exclusion Criteria:

1. presence of significant vision or motor problems which would impact ability to perform the task
2. significant self-reported motion sickness
3. vulnerable persons as defined in articles L1121-5 to 8 of the French Public Health Code

Primary outcomes:
measure: Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) Questionnaire
timeFrame: at inclusion
measure: UTAUT 2 Questionnaire
timeFrame: at 4-week
measure: UTAUT 2 Questionnaire
timeFrame: at 8-week
measure: UTAUT 2 Questionnaire
timeFrame: at 16-week
measure: UTAUT 2 Questionnaire
timeFrame: at 20-week
measure: UTAUT 2 Questionnaire
timeFrame: at 24-week
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Guillaume SACCO, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04409691: SCMC Trial on KHE With KMP (V.2020)
Official title: A Clinical Study on the Treatment of Kaposiform Hemangioendothelioma (KHE) With Kasabach-Merritt Phenomenon (KMP) by Hormone Shock and Sirolimus Maintenance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Kaposiform Hemangioendothelioma (KHE) With Kasabach-Merritt Phenomenon (KMP)
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 20
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: a phase I trial focusing on safety and efficacy of prednison shock plus sirolimus maintenance in treating Kaposiform hemangioendothelioma (KHE) with Kasabach-Merritt phenomenon (KMP)


Eligibility criteria: Inclusion Criteria:

* Kaposiform Hemangioendotheliomas with Kasabach-Merritt Phenomenon
* 0 - 12 years of age at the time of study entry
* Male or female
* Consent of parents (or the person having parental authority in families)
* Signed and dated written informed consent

Exclusion Criteria:

* with hematological diseases
* with other solid tumors
* with hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney
* dysfunction, and cardiopulmonary insufficiency
* with tuberculosis,cytomegalovirus and Epstein-Barr virus infection before the treatment

Primary outcomes:
measure: response to treatment
timeFrame: 6 months after taking the drug
Secondary outcomes:
measure: side effect rate
timeFrame: 6 months after taking the drug
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References:
Clinical trial NCT04985591: The Effect of Liposuction on Menses: a Retrospective Study
Official title: The Effect of Liposuction on Menses: a Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Menstrual Irregularity
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-08-02
Enrollment: 516
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prevalence of obesity nearly tripled from 1975 to 2021, resulting in liposuction, as an effective shaping method, to be performed more frequently. Liposuction is a surgical procedure that uses a specialized instrument to suck fat fragments in the subcutaneous fat layer through a small incision. Analyzing a large sample sizes of patients who had liposuction, we found that some female patients underwent menstrual irregularity after liposuction. In 2004, Carolyn et al. reported several cases in which there was a connection between liposuction and an early onset of menses. Further studies showed that an early onset of menses may be related to the volume of adipose tissue extracted, the amount of anesthesia given, the area of liposuction, and body weight. However, the sample of that study was small, as there were only 17 cases included in the statistical model, and there are few articles in which the impact of liposuction on menses has been studied. To better understand whether menstrual irregularity will occur after liposuction, patients with postmenopausal or preoperative menstrual irregularity were excluded, leaving a sample of 518 female patients to be reviewed. A better understanding of the impact of liposuction on menses may help clinical doctors predict the underlying risk of menstrual irregularity after liposuction and identify individuals at higher risk. The findings may contribute to further understanding of menstrual irregularity.


Eligibility criteria: Inclusion Criteria:patients who were in 18-55 and have a regular menses -

Exclusion Criteria:Patients who were younger than 18 years old or older than 55 years old, who were in the perimenopausal or postmenopausal stage or who had menstrual irregularity before plastic surgery were excluded from both groups.

-

Primary outcomes:
measure: menstrual irregularity
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00907491: Accuracy of Cough Detection in Healthy Adults
Official title: Use of Objective Cough Counting Device to Assess the Accuracy of Cough Detection in Healthy Adults Simulating Cough in Different Postures, Mobility and Environmental Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough
Keywords: Cough
Wheeze Rate
Respiratory Function Tests
Lead sponsor: KarmelSonix Ltd.
Sponsor class: INDUSTRY
First posted: 2009-05-22
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults 21 years and above

Brief summary: Cough is part of the defense mechanism to protect the lung from foreign particles and remove secretions from the airways. However, at times it becomes a bothersome, annoying symptom that interferes with the quality of life, sleep pattern and exercise tolerance of the patient.

People with respiratory infection, asthmatic patients and CF patients suffer from a multitude of pathologies of airways and are often inflicted with chronic cough.

Treatment of cough in these patients consists of many types of expectorants, cough suppressors, secretion modifiers, inhaled bronchodilators etc. In addition, chest physical therapy (PT) is often prescribed as part of the treatment regime.

The primary objective of the study is to evaluate the efficacy and validity of novel cough counting device based on the WIM Technology.


Eligibility criteria: Inclusion Criteria:

* Patient signed informed consent
* Patients above 21 years old
* No medical history

Exclusion Criteria:

* Skin lesions precluding attachment of sensors
* Pregnancy

Primary outcomes:
measure: To evaluate cough detection and counting technology (ACCA) for adult people in different recording conditions
timeFrame: within 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa,
country: Israel
facility: RAMBAM Health Care Campus
Study officials:
References:
Clinical trial NCT04785391: A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test
Official title: A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Lead sponsor: Astute Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 500
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult ICU patients with KDIGO stage 2 or 3 AKI.

Brief summary: The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject.


Eligibility criteria: Inclusion Criteria:

1. Males and females 21 years of age or older;
2. Receiving care in an intensive care unit;
3. Expected to remain in the ICU for at least 48 hours after enrollment;
4. Use of indwelling urinary catheter as standard care at the time of enrollment;
5. Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection;
6. Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria;
7. Written informed consent provided by patient or legally authorized representative (LAR).

Exclusion Criteria:

1. Prior kidney transplantation;
2. Comfort-measures-only status;
3. Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment;
4. Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic);
5. Special populations, pregnant women, prisoners or institutionalized individuals.

Primary outcomes:
measure: Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication
timeFrame: Within 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Chicago
name: Jay L Koyner, MD
role: PRINCIPAL_INVESTIGATOR
References: