louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02433314: An Open Label, Expanded Access Protocol With SAGE-547 for Super-Refractory Status Epilepticus
Official title: An Open Label, Expanded Access Protocol to Evaluate the Efficacy and Safety of SAGE-547 Injection in the Treatment of Subjects With Super-Refractory Status Epilepticus
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Super-Refractory Status Epilepticus
Lead sponsor: Sage Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-05-04
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: This is an open-label, expanded access protocol, designed to offer treatment with SAGE-547 to subjects in SRSE, and to evaluate the efficacy and safety of SAGE-547 administered as a continuous intravenous infusion to these subjects


Eligibility criteria: Inclusion Criteria:

* Subjects six (6) months of age and older
* Subjects who have:

  * Failed to respond to the administration of at least one first-line agent (e.g., benzodiazepine or other emergent initial AED treatment), according to the institution's standard of care, and;
  * Failed to respond to at least one second-line agent (e.g., phenytoin, fosphenytoin, valproate, phenobarbital, levetiracetam or other urgent control AEDs), according to the institution's standard of care, and;
  * Not previously been administered a third-line agent but have been admitted to an intensive care unit with the intent of administering at least one third-line agent for at least 24 hours; or who have previously failed zero, one or more wean attempts from third-line agents and are now on continuous intravenous infusions of one or more third-line agents and in an EEG burst or seizure suppression pattern; or who have previously failed one or more wean attempts from third-line agents and are now either not on at least one continuous infusion of a third-line agent or are on one or more continuous infusions of third-line agents but not in an EEG burst or seizure suppression pattern.

Exclusion Criteria:

* Subjects with SRSE due to anoxic/hypoxic encephalopathy with highly malignant/ malignant EEG features
* Children (subjects aged less than 18 years) with an encephalopathy due to an underlying progressive neurological disorder
* Subjects who have any of the following:

  1. a GFR low enough to warrant dialysis for whatever reason, but dialysis is not planned or non-continuous dialysis is planned;
  2. severe cardiogenic or vasodilatory shock requiring two or more pressors that is not related to third-line agent use;
  3. fulminant hepatic failure;
  4. no reasonable expectation of recovery or life-expectancy of less than 30 days.
* Subjects who are being administered more than three third-line agents concomitantly or in whom the qualifying wean cannot be completed per protocol

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Henrikas Vaitkevicius, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02584114: Brain Effects of Memory Training in Early Psychosis
Official title: Brain Effects of Memory Training in Early Psychosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Psychotic Disorders
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Brain & Behavior Research Foundation
First posted: 2015-10-22
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: People with psychosis show profound deficits in memory. A new cognitive remediation therapy using an app on a computer or mobile phone to improve memory has been effective in this population, but the neurobiological effects are unknown.

Objectives: 1) To use functional magnetic resonance imaging (fMRI) to examine brain changes during a working memory task before and after a 12 hour memory training intervention on a computer or mobile phone, 2) To use diffusion tensor imaging (DTI) to examine white matter connecting prefrontal and parietal lobe before and after training.

Methods: 46 people with psychosis will be randomized to a computerized training of either memory training or a control condition of non-memory games (language/card games) and will self-administer 4 hours of training over 4 days per week, for 3 weeks (12 hours total). Memory training will be done with the Peak app http://www.peak.net. Imaging data will be gathered with a 3 Tesla scanner pre and post training.


Eligibility criteria: Inclusion Criteria:

1. Male or female and between the ages of 18 and 40
2. Able to understand and sign an informed consent document in English.
3. Meet diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or psychosis not otherwise specified.

Exclusion Criteria:

1. Impaired intellectual functioning (full-scale IQ\<70).
2. Past or current history of a clinically significant central nervous system disorder that may contribute to psychotic symptoms or confound their assessment.
3. Current severe substance use disorder.

Primary outcomes:
measure: Change in functional Magnetic Resonance Imaging blood oxygen-dependent signal during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
timeFrame: 5 weeks
measure: Change in diffusion tensor imaging measured change in fractional anisotropy during working memory task performance before and after a 12 hour memory training intervention in people with early psychosis
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04651114: Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities
Official title: Pilot Testing a New Pregnancy Decision Making Tool for Women With Physical Disabilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disability Physical
Keywords: Medical decision making
Pregnancy, planned
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-12-03
Enrollment: 38
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A pre-post design was selected for feasibility and preliminary efficacy.
Primary purpose: OTHER

Brief summary: The purpose of this project is to develop, and pilot test a decision-making tool that is tailored for women with physical disabilities to support those women in making a decision about whether or not a pregnancy is right given the participant's situation.


Eligibility criteria: Inclusion Criteria:

* Physical disability, defined by loss or impairment of physical function limiting one or more important life activities
* Mild, moderate or severe disability severity; severity will be assessed based on the need for assistance with daily life activities and/or personal care
* Actively planning or in the process of making a decision about whether or not to get pregnant in the near future.

Primary outcomes:
measure: Final Decisional Conflict Scale Score - Values Clarity Sub-scale
timeFrame: 12 weeks
measure: Final Decisional Conflict Scale Score - Support Sub-scale
timeFrame: 12 weeks
measure: Final Decisional Conflict Scale Score - Uncertainty Sub-scale
timeFrame: 12 weeks
measure: Final Readiness to Make a Choice in Stage of Decision-Making Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Feasibility - Acceptability
timeFrame: 12 weeks
measure: Feasibility - Demand
timeFrame: 12 weeks
measure: Feasibility - Ease of Use
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Claire Kalpakjian, PhD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06976814: Facial Palsy Treatment
Official title: Facial Palsy Treatment: Investigating the Most Effective Modality of Therapy for Recovery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Palsy
Stroke Rehabilitation
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Primary objective of the study is to investigate the most effective treatment modalities available to speech language pathologist as well as movement difference by comparing them.


Eligibility criteria: Inclusion Criteria:

* Patients with 1st stroke
* Hemorrhagic stroke
* Ischemic stroke
* Right hemispheric stroke
* Left hemispheric stroke
* Normal cognitive skills (Based on Montreal cognitive assessment MOCA)
* Normal Language (Not Aphasic)
* Normal swallowing

Exclusion Criteria:

* Patients with Bell's palsy
* Facial trauma
* Post otitis media surgeries
* Neoplasm, malignant or tumor cell invasion of facial nerve
* Cognitive impairment
* Patients with aphasia
* Patients on defibrillator cardiac devices
* Patients with pacemakers or any other type of cardiac devices
* Multiple strokes

Primary outcomes:
measure: Sunnybrook Facial Grading System
timeFrame: Patients were enrolled for 30sessions as per the protocol. Participants were given 5 sessions in a week. Patients were assessed as baseline upon enrollment into the study and re-assessed beginning of each week.
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
References:
Clinical trial NCT06496555: Evaluation of U-AKIpredTM for Predicting AKI in Critically Ill Patients Within 12 Hours: a Multicenter Prospective Cohort Study
Official title: Evaluation of U-AKIpredTM for Predicting AKI in Critically Ill Patients Within 12 Hours: a Multicenter Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: External Effectiveness Validation of Model
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 2100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients

Brief summary: The goal of our study is to evaluate U-AKIpredTM for predicting AKI in critically ill patients within 12 h by the multicenter prospective cohorts. AKI was diagnosed by Kidney Disease Improving Global Outcomes (KDIGO) criteria. We designed five aspects including the overall fitting effecience evaluation, calibration curve, quantifying calibration performance, quantifying discrimination performance, quantifying clinical utility to evaluate the external validation model.


Eligibility criteria: Inclusion Criteria:

* critically ill patients who stayed in ICU for over 24 h;
* patients older than 18 years of age.

Exclusion Criteria:

* patients who admitted in ICU had been diagnosed acute kidney injury;
* patients who admitted in ICU had been diagnosed acute kidney disease;
* patients who admitted in ICU had been diagnosed chronic kidney disease;
* patients who admitted in ICU had performed kidney dialysis;
* patients who admitted in ICU had performed kidney transplantation;
* Pregnant women.

Primary outcomes:
measure: AKI occurrence
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05205655: Detection Dogs as a Help in the Detection of COVID-19
Official title: Canine Olfactory Detection and Its Relevance for the Medical Identification of Patients With COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Keywords: Biomedical detection dogs; Olfaction; Olfactory sense; Screening method; Sniffer dogs
Lead sponsor: Hôpital Universitaire Sahloul
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Canine olfactive detection has proven its efficacy in numerous situations (explosives, drugs, bank notes...) including for early diagnosis of human diseases: various cancers, alert of diabetic or epileptic people in immediate alarm of crisis.

Detailed description: Fighting such a viral outbreak requires a widespread testing, one of the key measures for tackling the pandemic. In June 2020, facing a decline of COVID-19, it is possible to say that countries that have mastered their outbreak, and were able to maintain the number of infected people low, need to perform fewer test to correctly monitor the outbreak, than those countries where the virus has spread more widely. And for the same reasons, the timing of testing is also crucial. A high rate of testing will be way more effective to slow an outbreak if conducted earlier on, at a time when there is fewer infectious

The aim of this study is to evaluate if the sweat produced by COVID-19 persons (SARS-CoV-2 PCR positive) has a different odour for trained detection dogs than the sweat produced by non COVID-19 persons. The study was conducted on 3 sites, following the same protocol procedures, and involved a total of 18 dogs. A total of 198 armpits sweat samples were obtained from different hospitals. For each involved dog, the acquisition of the specific odour of COVID-19 sweat samples required from one to four hours, with an amount of positive samples sniffing ranging from four to ten.

Eligibility criteria: Inclusion Criteria:

* Due to have a coronavirus swab test in the previous 24 hours
* Aged ≥ 18 years
* Suspected mild COVID-19 symptoms or have been exposed to COVID-19
* Written informed consent provided

Exclusion Criteria:

* Aged \< 18 years
* Written informed consent not provided
* Unable or unwilling to put a compresses for at least 4 h

Primary outcomes:
measure: Sensitivity and specificity precision of dogs to detect people with COVID-19 by their odour.
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sahloul
country: Tunisia
facility: Riadh Boukef
state: Sousse
Study officials:
affiliation: CHU Sahloul, Sousse, Tunisia
name: Riadh Boukef, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03308955: Analgesic Effect of Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery
Official title: Analgesic Effect of Ultrasound Guided Quadratus Lumborum Block Application After Laparoscopic Cholecystectomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy
Postoperative Pain
Nerve Block
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2017-10-13
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective,randomized,single blind
Primary purpose: TREATMENT

Brief summary: Laparoscopy is frequently used today for intraabdominal operations. Laparoscopic procedure has become the treatment of choice for many patients with symptomatic cholelithiasis. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain, despite a multimodal analgesic regime.

This is a randomised controlled trial efficay of the Quadratus Lumborum (QL) Block in terms of analgesic efficacy in patients who undergo laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

-Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent Laparoscopic Cholecystectomy

Exclusion Criteria:

* Previous history of opioid use preoperatively,
* Allergy to local anesthetics,
* The presence of any systemic infection,
* Uncontrolled arterial hypertension,
* Uncontrolled diabetes mellitus.

Primary outcomes:
measure: Visual Analog Pain Scale
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: tramadol consumption
timeFrame: Postoperative 24 hours
measure: side effect profile scores)
timeFrame: Postoperative 24 hour
measure: additional analgesic use
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Study officials:
affiliation: UNIVERSITY OF HEALTH SCIENCES BURSA YUKSEK IHTISAS TRAINING AND RESEARCH HOSPITAL
name: Korgün Ökmen, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03150355: Outcomes of Geriatric Hip Fractures in Assiut University Hospital
Official title: Outcomes of Geriatric Hip Fractures in Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2017-05-12
Enrollment: 301
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients aged 65 years old and older with fracture acetabulum , neck of femur , trochanteric , subtrochanteric and reverse trochanteric fractures admitted inside assuit university hospital

Brief summary: hip fractures are common problem specially in elderly population the incidence is increasing nowadays because of increased incidence of motor vehicle accidents

Detailed description: hip fractures are a common problem specially in elderly population the incidence is increasing nowadays because of increased incidence of motor vehicle accidents the incidence of morbidity and mortality is increasing today and the mortality rate is about 30% the aim of the study is follow up of the patients aged 65 years and older who experienced hip fractures for one year to evaluate the outcome of different ways of intervention in elderly population.

Eligibility criteria: Inclusion Criteria:

* patients aged 65 years and older
* with fractures acetabulum , neck of femur , trochanteric , subtrochanteric and reverse trochanteric fractures

Exclusion Criteria:

* no patient will be excluded

Primary outcomes:
measure: determine the outcome of geriatric hip fractures
timeFrame: one year
Secondary outcomes:
measure: determine magnitude of geriatric hip fractures
timeFrame: one year
Other outcomes:
measure: determine the readmission rate to the hospital and why they were readmitted
timeFrame: one year
measure: determine the risk factors for morbidity and mortality
timeFrame: one year
Locations:
Study officials:
References:
Clinical trial NCT00701155: Observational Study to Evaluate the Safety While Using Levemir®
Official title: Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 3593
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 or 2 diabetes patients

Brief summary: This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.


Eligibility criteria: Inclusion Criteria:

* After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria:

* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
* Subjects currently being treated with insulin detemir;
* Subjects who previously enrolled in this study
* Subjects with a hypersensitivity to insulin detemir or to any of the excipients
* Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

Primary outcomes:
measure: Incidence of serious ADRs incl. major hypoglycemias
timeFrame: after 24 weeks
Secondary outcomes:
measure: Number of serious adverse events
timeFrame: after 24 weeks
measure: Number of all adverse events
timeFrame: after 24 weeks
measure: Weight changes
timeFrame: after 24 weeks
measure: HbA1c
timeFrame: after 24 weeks
measure: Subgroup analysis of hypoglycemias
timeFrame: after 24 weeks
measure: Number of all hypoglycemic events
timeFrame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks.
measure: Variability in fasting Blood Sugar and average plasma glucose levels
timeFrame: after 24 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: