louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06408415: A Study of the Higher Cognitive Functions of the Human Brain With Single-neuron Activity Recording
Official title: A Study of the Higher Cognitive Functions of the Human Brain Based on the Use of Hyperflexible Neural Electrode-cortex for Single-neuron Activity Recording
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cognition
Keywords: Electrodes, Implanted
higher cognitive function
single neural activity
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Sciences
First posted: 2024-05-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients received treatments in Huashan hospital

Brief summary: This study aims to investigate that neural activity of higher cognitve function of human brain with hyperflexible neural electrode-cortex

Detailed description: In this study, patients who need intracerebral puncture and indwelling drainage tube, such as intracerebral hemorrhage and hydrocephalus, will be recruited. Before implanting electrodes, patients will be trained to do higher cognitive function tasks.During operation, electrode will be implanted accompanied by placing drainage tube. After operation, patients will perform tasks, while electrophysiological signals will be collected. At the end of study, electrode will be removed.

Eligibility criteria: Inclusion Criteria:

1. aged 18-70 years old.
2. have selective or confine operation indications:spontaneous basal ganglia hemorrhage or lobar hemorrhage that need catheter aspiration and drainage;hydrocephalus that need V-P shunt; need placing ommaya.
3. GCS score 12-15; must be able to communicate with investigators in Mandarin and comply with study requirements.
4. volunteered to participate in this study and sign informed consent.

Exclusion Criteria:

1. have severe cognitive dysfunction.
2. have psychiatric disorders, such as depression, anxiety disorders and schizophrenia.
3. long-term use of special medications, such as hormones, immunosuppressant, and anticoagulants.
4. be allergic to surgery instruments or medications.
5. have general anesthesia, surgery contraindications.
6. have acute cardiac infarction or heart arrest within 6 months.
7. have other neurosurgery contraindications assessed by investigators.
8. lactation or pregnancy.
9. have serious systemic disease or organ dysfunctions that affects study outcome or visits.
10. participate in other ongoing clinical trials.

Primary outcomes:
measure: recording local field potentiation
timeFrame: through study completion, an average of 2 year
measure: recording single neural spikes
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Neurosurgery, Huashan Hospital, Fudan University
name: Xuehai Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04761315: Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)
Official title: Detecting Atrial Fibrillation in Patients With an Embolic Stroke of Undetermined Source (From the DAF-ESUS Registry)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibrillation, Atrial
Keywords: cardiac implantable electronic devices
interatrial block
P-wave duration
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in sinus rhythm, with or without previous paroxysmal AF and with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT) capable of atrial activity monitoring were included in the study

Brief summary: The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

Detailed description: The presence of interatrial block (IAB) is associated with the development of atrial fibrillation (AF). The aim of this study was to determine whether P-wave duration and presence of IAB before the implantation of a cardiac implantable electronic device (CIED) are associated with the presence of atrial high rate episodes (AHRE), during long-term follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients in sinus rhythm
* with or without previous paroxysmal AF
* with dual-chamber pacemakers (PMs), implantable cardioverterdefibrillators (ICDs), and devices for cardiac resynchronization therapy (CRT)
* capable of atrial activity monitoring were included in the study

Exclusion Criteria:

-Previous documented atrial fibrillation

Primary outcomes:
measure: Atrial high rate new episodes
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00956215: Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
Official title: A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea
Vomiting
Keywords: post operative
obese
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of patients.

Detailed description: The purpose of this study is to evaluate the effectiveness of Aprepitant, also known as Emend, in reducing post-operative nausea and vomiting in morbidly obese patients. Post-operative nausea and vomiting that occurs in morbidly obese patients can greatly increase the chances of complications during the post-operative period. By treating morbidly obese patients with Aprepitant, the goal is to reduce the risk of such complications that may be induced by nausea and vomiting.

Eligibility criteria: Inclusion Criteria:

Subjects included in this study must be:

* Female
* At least 18 years of age
* Non-smoking
* At high risk for PONV
* Obese with a BMI of at least 45 kg/m2
* Undergoing upper gastrointestinal surgery requiring postoperative opioid analgesia

Exclusion Criteria:

Subjects will be excluded if:

* They have a known allergy to Aprepitant or Ondansetron
* They are currently taking Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole), or Propulsid (cisapride)
* They are pregnant
* They are breastfeeding
* They plan on getting pregnant in the 2 months following surgery
* They are not able to receive patient controlled analgesia (PCA) following surgery
* They have a known drug or alcohol abuse problem
* They have chronic nausea and vomiting

Primary outcomes:
measure: To assess the efficacy of 80mg Aprepitant in preventing post operative nausea or vomiting in morbidly obese patients (BMI of 45 kg/m2 or higher) undergoing upper gastrointestinal surgery.
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ashish Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03118115: Bioimpedance Variation of Free Flap for After Clamping
Official title: Bioimpedance Variation of Free Flap for After Clamping - MONITRANS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Keywords: bioimpedance
thrombosis
free flap
microsurgerie
breast reconstruction
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.
Primary purpose: BASIC_SCIENCE

Brief summary: MONITRANS project consist of developing a monitoring technology of post-operative breast reconstruction by detecting thrombosis. Its aim is to reducing time spent in hospital by monitoring patients at home.

Thrombosis following to abdominal free flap harvesting for breast reconstruction is a rare phenomenon (with a 2 until 15 % frequency). Moreover, it leads to ischemia by limiting water intake in the plasma compartments. The investigator would like to prove, by this research project, that they are able to detect ischemia via bioimpedance technology.

During abdominal free flap harvesting for breast reconstruction, there are few minutes where the flap is clamped because of anastomosis on the recipient vessels. The investigators would seize the opportunity of this step, which is similar to vascular thrombosis, to measure bioimpedance variations.

Therefore they would like to measure variations of the flap bioimpedance before and after vascular section. Another purpose consists of developing an algorithm which will detect postoperative thrombosis.


Eligibility criteria: Inclusion Criteria:

* patient suitable for a abdominal perforator based flap breast reconstruction
* age over 18 years old

Exclusion Criteria:

* pregnancy
* women with active pacemaker implant or artificial heart

Primary outcomes:
measure: Measurement of impedence
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Raphaël SINNA, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04458415: The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
Official title: The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Clinical Innovations
First posted: 2020-07-07
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.

Detailed description: The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.

Eligibility criteria: Inclusion Criteria:

* Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L\&D
* Requires panniculus retractor for cesarean delivery, as determined by the surgeon
* Non-emergent cesarean delivery
* Spinal or epidural anesthesia
* Low transverse skin incision
* Gestational age equal to or more than 32 weeks 0 days
* Singleton pregnancy
* Three or less previous cesarean deliveries.
* English speaking

Exclusion Criteria:

* Use of Alexis or any other retractor
* General anesthesia
* Fetal demise
* Placenta previa
* History of bariatric surgery
* Adhesive allergy

Primary outcomes:
measure: Time from when a subject lies on the OR table to fascial closure
timeFrame: During surgery-Time from when a subject lies on the OR table to fascial closure
Secondary outcomes:
measure: Time from skin incision to delivery
timeFrame: During surgery-skin incision to delivery
measure: Time from hysterotomy to delivery
timeFrame: During surgery-hysterotomy to delivery
measure: Time from skin incision to closure of fascia
timeFrame: During surgery-skin incision to closure of fascia
measure: Time from skin incision to skin closure
timeFrame: During surgery-skin incision to skin closure
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Michael J Paglia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04429815: Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19
Official title: Impact of Smoking and Nicotine on the Risk of Being Infected With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Behaviors
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 195
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: Subjects (smokers, smokers undergoing smoking cessation, non-smokers) who will require a serological test for COVID-19 as part of standard of care.

Brief summary: Several studies have shown that smokers have a higher risk of developing a severe form of COVID-19 once a person has been infected. This is explained by the damage caused by smoking at the bronchopulmonary level and an overexpression of some coronavirus receptors at the pulmonary level when exposed to tobacco. In contrast, recent data indicate that smokers are proportionally less infected with the COVID-19 virus since all available cohort data from around the world show a very low rate of smokers among COVID-19 infected subjects. The mechanisms at the origin of this protective effect are not known. All of these data lead us to question the real role of nicotine in the protective effect of tobacco observed in the general population against infection by the COVID-19 virus.

The objectives are :

* To show that subjects taking nicotine substitutes as part of a smoking cessation program are less infected with COVID-19 than non-smokers.
* To show that active smokers are less infected with COVID-19 than non-smokers.
* To compare the percentage of positive serological tests in subjects taking nicotine substitutes to the percentage of positive serological tests in active smokers.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* Subject who will require a serological test for COVID-19 virus as part of standard of care.
* Group 1: Active smoker since October 2019
* Group 2: Smoker undergoing smoking cessation and taking nicotine substitutes on a regular basis since October 2019
* Group 3: Non-smoker

Exclusion Criteria:

* Inpatient subject
* Subjects with a chronic serious pathology modifying the risk of exposure to COVID-19

Primary outcomes:
measure: Percentage of patients with a positive serological test for COVID-19.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Christian Rabaud
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00577915: Breast MRI Spectroscopy
Official title: Breast MRI Spectroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suspicion of, or Known Breast Cancer
Keywords: Breast cancer
MRI spectroscopy
Diagnostic radiology
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to provide physicians with additional information not available with standard imaging methods for breast disease.

As part of the MRI examination ordered by your physician, a new method of analyzing the images or pictures will be used. This new method is called spectroscopy and is used routinely on other parts of the body such as the prostate and brain. Pictures produced with this sequence may look slightly different than the regular MRI pictures. Using spectroscopy data, it may be possible to distinguish benign conditions of the breast from malignant tumors and provide more precise information than can be obtained with regular MRI.

Detailed description: Our aim is to perform MR Spectroscopy (MRS) on 150 evaluable patients at the end of their routine breast MRI examination using a software package from General Electric Medical Systems Milwaukee, WI). This will add time to the routine examination but will not involve additional injections of contrast. We will analyze the spectroscopic data to determine if benign lesions can be reliably differentiated from malignant ones.

Eligibility criteria: Inclusion Criteria:

* Scheduled for diagnostic breast MRI examination or interventional procedure for a known or suspected breast lesion

Exclusion Criteria:

* Patients who would be normally excluded from undergoing an MRI examination:

  * Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field

Primary outcomes:
measure: To determine if spectroscopy of the breast can be performed and can be functional in a clinical environment.
timeFrame: 12 months
Secondary outcomes:
measure: To determine if the data obtained can be reliably analyzed and useful to the final interpretation of the breast MRI examination.
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Sandra Brennan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03486015: Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination
Official title: Oral Sweet Solution to Prevent Pain During Neonatal Hip Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Region Örebro County
Sponsor class: OTHER
First posted: 2018-04-03
Enrollment: 100
Sex: ALL
Minimum age (years): 37
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the pain relieving effect of oral glucose during hip examinations on healthy, fullterm infants.

Detailed description: All healthy, fullterm infants undergoes a medical examination after birth where 21 different components are assessed. One of the components is the hip examination which appears to be painful. Since painful experiences early in life can cause longterm negative effects it is important to treat pain during painful procedures.

One hundred healthy, fullterm infants were randomized to either glucose or sterile water orally before the routine medical examination before discharge from the maternity ward.

Eligibility criteria: Inclusion Criteria:

* Healthy, fullterm infants that were undergoing a routine medical examination

Exclusion Criteria:

* Prematurity
* Parents inability to speak Swedish well enough to give consent
* Congenital malformations or other illnesses
* Any pain-relieving medicine administered in the previous 24 hours

Primary outcomes:
measure: Pain will be measured with ALPS-Neo (Astrid Lindgren and Lund children's hospitals pain and stress assessment scale for preterm and sick newborn infants, range 0-10 where higher number means a higher intensity of rated pain) by a nurse
timeFrame: The assessment is made by the nurse when the physician starts with the hip examination, approximately 60 seconds after the study solution has been given.
measure: Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by physician
timeFrame: The physician will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
measure: Pain will be measured by VAS (Visual analogue scale, range 0-10 where higher number means a higher intensity of rated pain) assessed by parent
timeFrame: The parents will make the VAS assessment directly after the physical examination is done, approximately 10 minutes after the study solution has been given.
measure: Total crying time will be measured
timeFrame: The total crying time is measured throughout the examination from zero minutes until approximately 10 minutes after the study solution has been given with the help of a stopwatch.
measure: Crying time during hip examination
timeFrame: The total crying time is measured from approximately 3 minutes from the study solution has been given until the hip examination has been completed (approx. during 30 sec up to 1 min) with the help of a stopwatch
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: