louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05940142: Prediction of Propofol Effect Compartment Concentrations
Official title: Prediction of Propofol Effect Compartment Concentrations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Analysis of Anaesthesia Depth
Lead sponsor: Karl Landsteiner University of Health Sciences
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients meeting the inclusion and exclusion criteria

Brief summary: The goal of this observational study is to learn about the prediction of the effect of Propofol by means of EEGs. The main questions it aims to answer are:

* Develop models that can reliably predict the effect of Propofol
* Select the most well suited model for clinical practice
* Compare this model to already existing models (e.g. Schnider-model)

Participants will asked to allow us to collect and use the EEG data recorded during the operations.


Eligibility criteria: Inclusion Criteria:

* Age of 18 or older at the time of the signature of the informed consent
* Signed informed consents
* Planned TIVA with Propofol

Exclusion Criteria:

* Use of extracorporal circulation (e.g., HLM, ECMO)
* Admission to an ICU/IMCU before the operation or planned admission to an ICU/IMCU after the operation
* Administration of Propofol seven days prior to the planned operation
* Missing informed consent
* All contraindications against TIVA (e.g., allergy against Propofol or soy)
* All operations where BIS monitoring cannot be used (e.g., skin lesions on the front)
* Patients for which the administration of Propofol could be potentially harmfull (e.g., severe heart failure with the risk of drop of blood pressure)
* Neurosurgical operations

Primary outcomes:
measure: Bilateral BIS values (derived from EEG)
timeFrame: During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).
measure: Propofol cumulative dose
timeFrame: During procedure (From the beginning of general anaesthesia (induction of anaesthesia) until the patient has woken up (end of anaesthesia)).
Secondary outcomes:
Other outcomes:
Locations:
city: Krems
country: Austria
facility: Klinische Abteilung für Anästhesie und Intensivmedizin
state: Niederösterreich
Study officials:
References:
Clinical trial NCT04209842: Effectiveness Gastric Balloon in Obese Adolescents
Official title: Utilization of Endoscopically Placed Intra-gastric Balloon in Obese and Morbid Obese Adolescents Combined With Behavioral Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Assess the effectiveness of utilization of endoscopically placed intra-gastric balloon in obese and morbid obese adolescents combined with behavioral support for weight loss and health optimization.


Eligibility criteria: Inclusion Criteria:

* Clinically obese or morbid obese males and females aged 14 - 19 years old (BMI \> 3.5 SD)
* Are able to attend biweekly to monthly sessions with our support team and are capable of adhering to the lifestyle changes advised

Exclusion Criteria

* Previous esophageal or gastric surgery or history of intestinal obstruction;
* History of moderate to severe inflammatory disease of the gastrointestinal tract such as esophagitis, gastric or duodenal ulcers or congenital anomalies such as atresias or stenosis; gastric or esophageal varices; congenital or acquired intestinal telangiectasis
* Hiatus hernia \>5 cm or \<5cm with associated severe or intractable gastro-esophageal reflux symptoms (assessed at balloon insertion);
* History of significant psychological disorder (permission sought from lead care giver).

Primary outcomes:
measure: change from baseline weight
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Lucille Packard Children's Hospital
state: California
Study officials:
affiliation: Stanford University
name: Roberto Gugig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Monique T Barakat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04204642: SEarchiNg BiomarkErs Cerebral Amyloid Angiopathy (SENECA)
Official title: SEarchiNg BiomarkErs Cerebral Amyloid Angiopathy (SENECA): Italian Network for the Study of CAA
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Amyloid Angiopathy
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 500
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sporadic and familial CAA patients

Brief summary: Cerebral amyloid angiopathy (CAA) is one of the major types of cerebral small vessel disease, and a leading cause of spontaneous intracerebral hemorrhage and cognitive decline in elderly patients. Although increasingly detected, a number of aspects including the pathophysiology, the clinical and neuroradiological phenotype and the disease course are still under investigation. The incomplete knowledge of the disease limits the implementation of evidence based guidelines on patient's clinical management and the development of treatments able to prevent or reduce disease progression.

The SENECA (SEarchiNg biomarkErs of Cerebral Angiopathy) project is the first Italian multicentre cohort study aimed at better defining the disease natural history and identifying clinical and neuroradiological markers of disease progression. By a multidisciplinary approach and the collection of a large and well phenotyped series and biorepository of CAA patients, the study is ultimately expected to improve the diagnosis and the knowledge of CAA pathophysiological mechanisms.

Detailed description: The SENECA is an Italian multicenter network integrating the experience of neurologists, neuroradiologists, neuro-ophthalmologists and biologists and allowing the standardized collection of a well-characterized wide series of sporadic and familial CAA patients.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients ≥55 years (with the exception of genetic cases), referred to the participating centres, with a diagnosis of possible probable and definite symptomatic or asymptomatic CAA, defined according to the modified Boston neuroradiological criteria, who had undergone at least one brain MRI (mandatory requirement for inclusion of the patient in the study) will be recruited.

Exclusion Criteria:

* evidence of other causes of cerebral hemorrhage (brain tumors, arteriovenous malformations, aneurysms, cavernous angiomas), contraindications to brain MRI, pregnancy and breastfeeding

Primary outcomes:
measure: Clinical and neuroradiological phenotype
timeFrame: 24 months
Secondary outcomes:
measure: severity of the neuroradiological picture
timeFrame: 24 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: UOC Neurologia 5
Study officials:
References:
Clinical trial NCT06063642: Neurofeedback for Internet Gaming Addiction
Official title: Real-time Functional Magnetic Resonance Imaging Neurofeedback Treatment for Young Adults With Internet Gaming Addiction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Internet Gaming Disorder
Keywords: neurofeedback
behavior addiction
Lead sponsor: University of Macau
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 28
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible candidates will be randomly assigned to either receive the experimental feedback intervention or sham feedback intervention.
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to evaluate the therapeutic potential of real-time functional magnetic resonance imaging (MRI) neurofeedback in alleviating internet gaming disorder (IGD) symptoms by training individuals with such symptoms to down-regulate the activity in their reward-processing-related midbrain regions.


Eligibility criteria: Inclusion Criteria:

* Meet at least five of the Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5) criteria for IGD and score 38 or above on the Internet Addiction Test (IAT)
* First language is Chinese (Mandarin)
* Right-handed
* Have played the mobile game "King of Glory" for more than 3 years
* Ability to give informed consent
* Normal or corrected-to-normal vision

Exclusion Criteria:

* Any primary diagnosis of a current psychological or neurological disorder
* Any history of psychological or neurological disorder
* Any MRI contraindication
* Currently on a psychotropic medication
* Any history of substance dependence
* Any history of brain injury or surgery

Primary outcomes:
measure: Change from Baseline in self-reported urge for internet gaming as assessed by Visual Analog Scales (1 to 100)
timeFrame: Up to 30 days after the intervention session
Secondary outcomes:
measure: Change in reward-related activity during exposure to internet gaming videos
timeFrame: Up to 3 days
measure: Change in inhibitory response in the affective Go/Nogo task
timeFrame: Up to 3 days
Other outcomes:
Locations:
city: Taipa
country: Macau
facility: Centre for Cognitive and Brain Sciences, University of Macau
Study officials:
affiliation: University of Macau
name: Zhen Yuan, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06120842: Evaluation of the Bimatoprost Implant System Used in Combination With the SpyGlass Intraocular Lens Compared to Timolol Ophthalmic Solution
Official title: A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety, Efficacy, and Dose-response of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Cataract
Glaucoma
Ocular Hypertension
Lead sponsor: SpyGlass Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 201
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is a randomized study to evaluate and compare two doses of the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension
* Planned removal of cataract
* Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception

Exclusion Criteria:

* Uncontrolled systemic disease
* History of incisional/refractive corneal surgery
* Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliation, or pigmentary glaucoma
* History of incisional glaucoma surgery or intraocular injections
* Other ocular diseases, pathology, or conditions

Primary outcomes:
measure: Mean IOP Reduction from Baseline (mmHg)
timeFrame: Weeks 2 and 6, and Month 3
Secondary outcomes:
measure: Mean IOP
timeFrame: Weeks 2 and 6 and Months 3, 6, 12, 18, 24, 27, 30, 33, and 36
measure: Mean IOP Change from Baseline
timeFrame: Months 6, 12, 18, 24, 27, 30, 33, and 36
measure: Time to postoperative introduction of IOP-lowering medications
timeFrame: Total Study Period of 36 Months
measure: Number of IOP-lowering medications introduced postoperatively
timeFrame: Total Study Period of 36 Months
measure: Proportion of eyes achieving BCDVA 20/40 or better
timeFrame: Months 3, 6, and 12
measure: Manifest refraction spherical equivalent
timeFrame: Month 3
Other outcomes:
measure: Number and Rates of Adverse Events
timeFrame: Total Study Period of 36 Months
Locations:
city: Glendale
country: United States
facility: Arizona Advanced Eye Research Institute
state: Arizona
Study officials:
affiliation: SpyGlass Pharma, Inc.
name: Chris Hafner
role: STUDY_CHAIR
References:
Clinical trial NCT01244542: Pain and Schizophrenia
Official title: Pain and Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Schizophrenia
Keywords: Schizophrenia
DSM IV criteria
Pain insensitivity
Painful perception
Opioid receptors
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of the investigators project is to explore the mechanisms of pain insensitivity in patients with schizophrenia, in order to prevent its invalidating consequences. The investigators will couple methods of experimental psychology with EEG and blood samplings, in order to distinguish the role of non-painful perception, attention, aversive effects, and pain expression, and the investigators will explore an original neurobiological hypothesis regarding the activation of opioid receptors.


Eligibility criteria: Inclusion Criteria:

* Patients with schizophrenia (criteria DSM IV) or healthy controls matched with patients on age, sex and education level
* 18-55 years old

Exclusion Criteria:

* Past history affecting CNS
* Intake of psychotropic drugs, except for patients
* Metabolic disorder affecting sensory processing (diabetes)
* Intake of benzodiazepines

Primary outcomes:
measure: Unpleasant stimuli
timeFrame: during experimental session
measure: Unpleasant stimuli
timeFrame: during experimental session
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon Cedex
country: France
facility: Service de Psychiatrie Adulte2, Place Saint-Jacques - ZA 481, Centre Hospitalier Saint-Jacques
city: Erstein Cedex
country: France
facility: Service de Psychiatrie Adulte, Secteur G11, Centre Hospitalier de Erstein, 13 route de Krafft
city: Strasbourg Cedex
country: France
facility: Centre d'évaluation et de traitement de la douleur, Hôpitaux Universitaires de Strasbourg
city: Strasbourg Cedex
country: France
facility: Centre d'Investigation Clinique - Hôpitaux Universitares de Strasbourg
city: Strasbourg cedex
country: France
facility: Service de Psychiatrie - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Anne Giersch, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00855842: Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
Official title: Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abortion, Induced
Keywords: second trimester abortion
labor induction abortion
second trimester medical abortion
pregnancy
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)

Detailed description: This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.

Eligibility criteria: Inclusion Criteria:

* Requesting abortion 19-23 weeks
* No contraindication to induction abortion

Exclusion Criteria:

* Fetal demise
* Ruptured membranes
* Evidence of pelvic infection
* Inability to give informed consent

Primary outcomes:
measure: Length of Medical Abortion
timeFrame: hours since the start of medical abortion
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Lynn Borgatta, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04567342: Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
Official title: Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventable Disease, Vaccine
Health Care Utilization
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 1312
Sex: ALL
Minimum age (years): 12
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our objective is to determine the effectiveness of varied outreach methods (e.g. automated reminder calls/text messages with or without personalized calls/texts) to children age 12-14 months or 4 years old who are due for a WCC visit and don't have one scheduled in the next 45 days on the outcomes of appointment scheduling, appointment completion, and receipt of the MMR vaccination.


Eligibility criteria: Inclusion Criteria:

* Age: 12-14 months old OR 4 years old
* Has not yet received first MMR (for 12-14 month olds) OR second MMR (for 4 year olds)
* Has not had a well child check in past 365 days (for 4 year olds)
* No appointment scheduled in the next 45 days
* Parent preferred language = English or Spanish

Exclusion Criteria:

* Phone number not available in electronic medical record

Primary outcomes:
measure: Receipt of MMR Vaccination
timeFrame: By 15 months of age (for children who are 12-14 months old), or within 3 months of receiving intervention (for children age 4 years old)
Secondary outcomes:
measure: Appointment Scheduled
timeFrame: Within 2 weeks of receiving intervention
measure: Appointment Completed
timeFrame: Within 8 weeks of receiving intervention
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Children's
name: William B Brinkman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06267742: Clinical Trial to Evaluate MDW for Early Detection of Sepsis
Official title: Clinical Trial to Evaluate Early Sepsis Indicator Monocyte Distribution Width (MDW) for Early Detection of Sepsis or Developing Sepsis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sepsis
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
name: West China Hospital
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2024-02-20
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of any race and ethnicity can be enrolled to this study. Patients with a prior chronic immunosuppressive disease and subjects with hematological malignancy can also be enrolled. This study requires at least 250 sepsis subjects and 1,100 non-sepsis subjects.

Brief summary: This study is intended to clinically verify Monocyte Distribution Width (MDW) parameter of DxH 900 Hematology Analyzer for use in early detection and risk assessment of sepsis, severe sepsis, and septic shock in critically ill patients in Emergency Department (ED). This study is also aimed to provide study supporting data for the product to be marketed in China.

Detailed description: To verify the clinical performance of MDW parameter in detection of sepsis through a multicenter, prospective study of adults undergoing complete blood count with differential ("CBC with differential") in the ED.

To clarify the cutoff 20.0 established in the pivotal trial. The cutoff was established for the objective of achieving the highest sensitivity at the optimal specificity level. Patients whose MDW value is higher than the cutoff will be identified as sepsis patients and those whose MDW value is equal to or lower than the cutoff are non-sepsis patients.

Eligibility criteria: Inclusion Criteria:

* Adult subjects (18-89 years) presenting to ED.
* CBC with Differential performed upon presentation as part of standard of care.
* Subject scheduled for at least 12 hours follow-up during ED (or inpatient, if admitted to the hospital) visit
* Signed the informed consent form

Exclusion Criteria:

* Subjects previously enrolled in this study (i.e., re-enrollment to this study is not allowed).
* The subject is discharged from the hospital within 12 hours after ED visit

Primary outcomes:
measure: sensitivity, specificity
timeFrame: 2022.3-2024.3
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine
Study officials:
affiliation: BECKMAN COULTER
name: DONG LI, MS
role: STUDY_DIRECTOR
References: