louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03521414: Glasgow Coma Scales and General Anesthesia
Official title: The Effect of Glasgow Coma Scales on General Anesthesia in Neurosurgery Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Awareness
Keywords: Bispectral index
Glasgow Coma Scale
intracranial pathology
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The study evaluates the general anesthesia management with BIS monitorization in terms of hemodynamic stability, drug concentrations and drug consumption in patients who underwent surgery due to intracranial pathology and who were divided in three different GCS groups.

Detailed description: BIS monitoring is mostly used for anesthesia depth and sedation level follow-up, however it can also be used for monitoring consciousness after resuscitation of cases with acute brain injury and cardiac arrest. It is not always possible to monitor and objectively measure the changes in the level of consciousness in clinical practice. Therefore, device-based methods have been introduced in monitoring the state of consciousness. Bispectral index (BIS) monitoring may be preferred in follow up of the state of consciousness in critical patients such as those with acute brain injury, in terms of ease of use, ability to obtain numerical results and continuous monitoring. BIS monitoring is mostly used for follow up of anesthesia depth and sedation level, while it can also be applied for monitoring state of consciousness following resuscitation in cases with acute brain injury and cardiac arrest.In this study, we aimed to investigate general anesthesia management performed by bispectral index monitoring in patients who underwent surgery due to intracranial pathology and with different Glasgow Coma Scales.

Eligibility criteria: Inclusion Criteria:

* 18 and 65 years
* ASA II-III
* intracranial surgery

Exclusion Criteria:

* Patients with additional disease (electrolyte impairment, uremia, etc.),
* liver and renal failure affecting consciousness level other than intracranial pathology

Primary outcomes:
measure: BIS, Consumption of the inhalation agents
timeFrame: 200 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05041114: SWITCH II Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Official title: Stentrode With Thought-controlled Digital Switch: An Early Feasibility Study of the Safety of an Endovascular Motor Neuroprosthesis in Participants With Severe Upper Limb Impairment.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neurologic Disorder
Paralysis
Paralysis; Stroke
Amyotrophic Lateral Sclerosis
Muscular Dystrophies
Spinal Cord Injury
Stroke, Lacunar
Stroke, Brainstem
Upper Limb Injury
Spinal Muscular Atrophy
Lead sponsor: Synchron, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Synchron Motor Neuroprosthesis (MNP) is intended to be used in subjects with severe motor impairment, unresponsive to medical or rehabilitative therapy and a persistent functioning motor cortex. The purpose of this research is to evaluate safety and feasibility.

The MNP is a type of implantable brain computer interface which bypasses dysfunctional motor neurons. The device is designed to restore the transmission of neural signal from the cerebral cortex utilized for neuromuscular control of digital devices, resulting in a successful execution of non-mechanical digital commands.


Eligibility criteria: Inclusion Criteria:

1. Severe motor impairment
2. Able to give consent
3. Appropriate candidate for neurointerventional procedure
4. Able and willing to access all clinical testing and not impeded by geographical location
5. Proficient in English
6. Have a study partner

Exclusion Criteria:

1. Active condition resulting in immunosuppression
2. Unsuitable for general anaesthetic
3. Anaphylactic allergy to contrast media
4. Allergy to nickel
5. History of pulmonary embolism
6. History of recent deep vein thrombosis
7. Psychiatric or psychological disorder
8. No study partner or caregiver
9. Unable to provide evidence of COVID vaccination

Primary outcomes:
measure: Treatment related adverse events
timeFrame: 12 months post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Sydney Local Health District
state: New South Wales
city: Brisbane
country: Australia
facility: Metro North Health
state: Queensland
city: Melbourne
country: Australia
facility: Melbourne Health
state: Victoria
Study officials:
References:
Clinical trial NCT01174914: Effectiveness Study Low-Dose Naltrexone Versus ARV's for HIV+
Official title: Phase 2 Comparison of Low-Dose Naltrexone vs ARV Effectiveness in HIV+ Progression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Seropositivity
Lead sponsor: The Ojai Foundation
Sponsor class: OTHER
First posted: 2010-08-04
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the vast majority of those infected with HIV virus who are untreated, there is deterioration in immune health over a period of months or years inevitably leading to full-blown AIDS and demise. Treatment with ARV's stop or slow down this deterioration if started before a certain degree of progression occurs and has saved millions of lives. The investigators' study hypothesis is that effectiveness of a very low dose of an FDA-approved medication, naltrexone hydrochloride, (Low-Dose Naltrexone, or LDN) will compare favorably to ARV's to prevent progression of HIV+ toward immune deterioration and full-blown AIDS.

Detailed description: The LDN (low-dose naltrexone) vs ARV (anti-retroviral drugs) Effectiveness Study in Mali sponsored by The Ojai Foundation in California-USA is a clinical research study endorsed and approved by the Malian Government. Naltrexone hydrochloride is a generic, FDA-approved since 1998 drug, an opioid antagonist that has clinically shown immune enhancing/modulating qualities in very low dosage and may offer an alternative to ARV drugs that is effective, non-toxic, easily available, inexpensive, with simple once-daily at bedtime administration. LDN capsules must be created by compounding pharmacists to get these ultra-small doses. Due to toxicity of current ARV drugs and need for special medical management young HIV infected children are largely neglected particularly in developing countries; LDN can also be made available in a transdermal cream for infants and children who are HIV infected.

Eligibility criteria: Inclusion Criteria:

* HIV-1 infected
* CD4 count over 350 (arm 1/group 1)
* CD4 count over 200 and on ARV's (arms 2,3/groups 2,3)
* Age between 18 \& 60
* Males or females

Exclusion criteria:

* HIV-1 seronegative
* HIV-2 infected
* CD4 count lower than 200
* patients under age 18
* Those refusing to be in study
* Pregnant or breast-feeding women
* Patients under immuno-suppressor therapy
* Those with renal or hepatic dysfunction
* Malaria or tuberculosis

Primary outcomes:
measure: CD4+ percentage (change in HIV-1 seropositive patients)
timeFrame: 9 MONTHS
Secondary outcomes:
measure: Clinical assessment of evidence of AIDS or other serious illness
timeFrame: 9 MONTHS
Other outcomes:
Locations:
city: Bamako
country: Mali
facility: University Hospital of Point G
Study officials:
affiliation: Professor, Bamako University School of Medicine
name: Abdel K Traore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03401814: Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases
Official title: Imaging Response to Immunotherapy and Radiation Therapy in Patients With Liver Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Metastases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Radiation patients with liver metastases

Brief summary: Patients will be imaged with MRE at the time of the RT planning MRI, prior to the induction of RT and immunotherapy. Research imaging will be in addition to standard imaging studies performed at time points consistent with the standard of care (at the time of the RT planning MRI and the first clinical follow-up). An additional MRE exam will be performed at the end of treatment outside the standard of care imaging.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of solid cancers with the presence of one or more liver metastases
* Minimum metastasis diameter ≥ 2 cm
* Planning to receive radiation therapy with immunotherapy
* Willingness to participate in mandatory imaging studies at Mayo Clinic Rochester

Exclusion Criteria:

* Contraindications for MRI including claustrophobia, pace maker, metal implants, aneurism clips
* Patients who are not able to consent

Primary outcomes:
measure: Quantify tissue mechanical properties of the liver and liver tumor using MRE in patients receiving radiation therapy + immunotherapy at baseline, mid-treatment and time of followup imaging determined by standard of care to assess response to therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sean Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445014: Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule
Official title: Pilot Study for Imaging of Barrett's Esophagus Using an Spectrally Encoded Confocal Microscopy Tethered Endoscopic Capsule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Barrett's Esophagus
Gastric Acid Reflux
Keywords: Barrett's
GERD
Capsule
SECM
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2015-05-15
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).

Detailed description: 36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.

The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Eligibility criteria: Inclusion Criteria:

* Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
* AND Subject must be able to give informed consent.
* AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.

Exclusion Criteria:

* Subjects with any history of or known upper gastrointestinal strictures
* OR Subjects with a history of Crohn's disease,
* OR Subjects with difficulty swallow

Primary outcomes:
measure: Feasibility for Imaging of Esophagus Using an SECM Tethered Endoscopic Capsule.
timeFrame: 20 minute visit (5-7 minute imaging)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Guillermo Tearney, MD., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02701114: Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty
Official title: A Comparison of Proximal Versus Distal Continuous Adductor Canal Blocks After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Operative Pain
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate pain control of continuous adductor canal blocks placed proximally versus distally within the canal. The investigators hypothesize that there will be similar pain control between both groups.

Detailed description: This study is a non-inferiority trial designed to determine whether placement of a continuous block within the adductor canal has a substantial impact on pain following total knee arthroplasty. Our primary outcome to determine this difference will be opioid consumption within the first day following surgery. Secondary outcomes will include: pain scores, quadriceps strength, and distance ambulated during physical therapy.

Eligibility criteria: Inclusion Criteria:

* Unilateral Total Knee Arthroplasty
* ASA physical status I-III
* \>18 years old
* Non-pregnant
* Consent to participate in the study

Exclusion Criteria:

* Refusal to participate
* \<18 years old
* Chronic opioid use
* Localized infection Pregnancy Pre-existing coagulopathy Allergy to ultrasound gel or local anesthetics Contraindication to or refusal of spinal anesthetic

Primary outcomes:
measure: Opioid Consumption (IV Morphine Equivalents)
timeFrame: 24 Hours
Secondary outcomes:
measure: Opioid Consumption (IV Morphine Equivalents)
timeFrame: 48 Hours
measure: Pain (Numeric Rating)
timeFrame: 48 Hours
measure: Quadriceps Strength (% of Baseline)
timeFrame: 48 Hours
measure: Distance Ambulated (Feet)
timeFrame: 48 Hours
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
affiliation: Virginia Mason Medical Center
name: Neil A Hanson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meier AW, Auyong DB, Yuan SC, Lin SE, Flaherty JM, Hanson NA. Comparison of Continuous Proximal Versus Distal Adductor Canal Blocks for Total Knee Arthroplasty: A Randomized, Double-Blind, Noninferiority Trial. Reg Anesth Pain Med. 2018 Jan;43(1):36-42. doi: 10.1097/AAP.0000000000000692.
Clinical trial NCT00154414: Effect of Liraglutide on Blood Glucose Control in Japanese Subjects With Type 2 Diabetes
Official title: Effect of Liraglutide on Glycaemic Control in Japanese Subjects With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 226
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Japan. The aim of this research trial is to evaluate the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in Japanese subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with type 2 diabetes and treated with diet therapy with or without single oral drug therapy
* 7.0 % =\< HbA1c \< 10.0 %
* Body Mass Index (BMI) \< 30.0 kg/m\^2

Exclusion Criteria:

* Subjects treated with thiazolidinediones or insulin
* Subjects with any serious medical conditions

Primary outcomes:
measure: HbA1c
timeFrame: after 14 weeks treatment
Secondary outcomes:
measure: Glycaemic control parameters (fasting plasma glucose, post prandial plasma glucose) after 14-week treatment
measure: Body weight after 14 weeks.
measure: Safety and tolerability
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Seino Y, Rasmussen MF, Zdravkovic M, Kaku K. Dose-dependent improvement in glycemia with once-daily liraglutide without hypoglycemia or weight gain: A double-blind, randomized, controlled trial in Japanese patients with type 2 diabetes. Diabetes Res Clin Pract. 2008 Aug;81(2):161-8. doi: 10.1016/j.diabres.2008.03.018. Epub 2008 May 20.
citation: Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
Clinical trial NCT01835314: Compassionate Use of Stiripentol in Dravet Syndrome
Official title: Compassionate Use of Stiripentol in Dravet Syndrome
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Dravet Syndrome
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2013-04-18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT

Brief summary: Compassionate use of Stiripentol in Dravet Syndrome. This is a treatment protocol, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

Detailed description: This is a treatment protocol for compassionate use, not a research study, therefore children will only be monitored on a clinical basis for seizure improvement predominantly by parent and caregiver report.

Eligibility criteria: Children with genetic confirmation of Dravet syndrome (a documented sodium channel, voltage-gated, type I, alpha subunit (SCN1A) mutation) or clinical confirmation of Dravet syndrome by two pediatric neurologist will be considered to have Dravet syndrome. In order to enter the treatment protocol there will be documented treatment failure of at least two therapeutic anticonvulsants excluding Na channel blockers. Anticonvulsants that are Na channel blockers such as carbamazepine and lamotrigine as known to provoke seizures in this patient population.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado/Children's Hospital Colorado
name: Kelly Knupp, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00636714: Comparison of 2 Methods to Achieve Tight Glucose Control in Cardiovascular ICU Patients
Official title: Randomized Controlled Trial of Nurse-directed vs Nomogram-directed Intensive Glucose Control in the CVICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperglycemia in Critically Ill Patients
Keywords: intensive insulin therapy
glucose control
nurse directed
nomogram directed
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: There is current evidence that maintaining ICU patient's blood sugar between 4.4-6.1 saves lives. However, this is difficult to do in the ICU and carries risks of lowering the blood sugar too much. In addition, the best way to achieve this control is not known. Many strict nomograms that provide a standardized approach for nurses have been developed and validated, including one here at SMH. However, these nomograms cannot apply to all patients at all times, especially ICU patients whose needs are rapidly changing. ICU nurses are at the bedside constantly, are very familiar with their patient's needs, and have decades of experience in titrating medication doses without a nomogram to achieve a pre-determined response (i.e. medications to achieve pre-selected blood pressure). Indeed, once the bedside nurse has bought into the importance of the concept of tight glucose control and have been introduced to the nomogram here at SMH, their experience and intuition may be more adaptable to the changing needs of the patient than an inflexible paper nomogram. This study will compare glucose control using our current standard nomogram versus no nomogram (i.e. nurse directed) in order to determine whether the nomogram should continue to be used.


Eligibility criteria: Inclusion Criteria:

Patients:

* adult CVICU pts
* requires insulin therapy for glucose greater than 8 mmol/L
* anticipated ICU stay \> 24 hrs
* not in DKA/HHNK
* mechanically ventilated

Exclusion Criteria:

* MD refusal
* no IV access for insulin
* allergy to insulin
* DNR or moribund as determined by the clinical team

Primary outcomes:
measure: Mean area-under-the curve for blood glucose within target per shift
timeFrame: over 12 hours
Secondary outcomes:
measure: Hypoglycemia frequency
timeFrame: per shift
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Clarence Chant, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chant C, Mustard M, Thorpe KE, Friedrich JO. Nurse- vs nomogram-directed glucose control in a cardiovascular intensive care unit. Am J Crit Care. 2012 Jul;21(4):270-8. doi: 10.4037/ajcc2012713.