louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03727607: TIVA Versus Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery
Official title: A Randomized Controlled Trial - Total Intravenous Anaesthesia Versus Inhaled Desfluran Anaesthesia in Patients Undergoing Bariatric Surgery. Postoperative Pain and Nausea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Total Intravenous Anesthesia
Desflurane
Obesity
Pain, Postoperative
Nausea, Postoperative
Lead sponsor: Ostfold Hospital Trust
Sponsor class: OTHER
First posted: 2018-11-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control trial.
Primary purpose: TREATMENT

Brief summary: Many factors during laparascopic surgery leads to PONV (postoperative nausea and vomiting), such as C02 insufflations causing peritoneal stretch and irritation and type of anaesthesia given during surgery.

The two anesthetic techniques used in bariatric surgery are gas anesthesia (Remifentanil TCI and Desfluran) and Total Intra Venous Anesthesia (TIVA) with propofol. There are studies which have shown a reduction in postoperative nausea and vomiting following TIVA, and there are publications showing no statistically significant difference.

The aim of this study was to investigate the best anaesthetic approach for obese subjects, evaluating awakening time, postoperative nausea and pain.

Our hypothesis was based on the fact that Propofol is a lipid-soluble anesthetic and therefore might have a prolonged effect in obese patients, leading to a longer awakening time along with postoperative nausea and vomiting. This hypothesis is also described earlier by obese patients have more depots (bulk fat) and also more fat surface making anaesthetics storage more easier, and also that the anesthetic will return into the circulation when the administration is stopped \[18\].


Eligibility criteria: Inclusion Criteria:

* BMI ≥35 kg/m2 with at least one comorbid condition or BMI ≥40 kg/m2.

Exclusion Criteria:

* drug abuse
* severe mental illness
* age\<18
* serious medical condition; cancer, end-stage lung disease (ASA\>3) or allergies to any drugs used in the study

Primary outcomes:
measure: Awakening time after surgery
timeFrame: 2 hours postdose
measure: Degree of nausea and vomiting after surgery
timeFrame: 48 hours postsurgery
measure: Degree of pain after surgery
timeFrame: 48 hours post surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02035007: Transpulmonary Thermodilution Measurements in Patients With Heart Diseases
Official title: Transpulmonary Thermodilution Measurements in Patients With Heart Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-01-14
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: 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 examine the validation of the PiCCO (Pulse Contour Cardiac Output)-derived transpulmonary thermodilution technology in patients with heart diseases.

Detailed description: * How do PiCCO and PAC (pulmonary artery catheter) derived hemodynamic variables change in different cardiac pathologies?
* How do PiCCO hemodynamic variables compare to transthoracic echocardiographic parameters in different cardiac pathologies?
* How does GEDV (global enddiastolic volume) correlate with left ventricles end-diastolic volume (LVEDV) assessed by LV (left ventricle) ventriculography and echocardiography?
* How do PiCCO cardiac function variables (GEF \[global ejection fraction\]; CFI \[cardiac function index\]) correlate with LV dP/dt max, LVEF (left ventricular ejection fraction) assessed by LV ventriculography and echocardiography, LVFAC (left ventricular fractional area of change), LV stroke work index (LVSWI) and cardiac power (CP)?
* How does GEDV compare to LVEDV and left ventricular end-diastolic pressure (LVEDP) as assessed by the pulmonary artery occlusion pressure (PAOP)?
* How does right ventricular function influence GEDV, GEF and CFI?

Eligibility criteria: Inclusion criteria:

* Coronary heart disease without impaired left ventricular function \[LV-EF \> 50%\] (n=10, control group)
* Coronary heart disease with impaired left ventricular function \[LV-EF \< 50%\] (n=10)
* Dilated cardiomyopathy (n=10),
* Aortic valve stenosis (n=10),
* Mitral valve regurgitation (n=10),
* Diastolic left ventricular dysfunction (n=10) and
* Right heart failure (n=10)

Exclusion criteria:

* Patients with catecholamine dependent cardiogenic shock, severe respiratory distress because of pulmonary oedema, intubated patients, patients with atrial fibrillation, atrioventricular conduction abnormalities, and slow ventricular tachycardia will not be included.
* Moreover patients not being able to give informed consent are excluded. Even more, pregnant women are excluded from the study due to the radiation exposure in line with heart catheterization. A pregnancy test will be performed prior to participating with this study.
* The age does not represent an exclusion criterion.

Primary outcomes:
measure: Cardiac Output, Preload values (GEDV)
timeFrame: Day 1 only
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Medical Intensive Care Unit, University Hospital of Zurich
Study officials:
affiliation: University Hospital Zurich, Medical Intensive Care Unit
name: Marco Maggiorini, Prof MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02318407: A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Subjects With Osteoarthritis Knee Pain
Official title: A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 403 in Younger and Older Subjects With Osteoarthritis Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoarthritis
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2014-12-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a sequential, randomized, double-blind, placebo controlled, multiple dose, dose escalation study in subjects with OA knee pain (n=32; 8/cohort). In each cohort, subjects will be randomized 3:1 to receive SC AMG 403 or placebo once every 4 weeks for a total of 4 doses (Q28D x 4).


Eligibility criteria: Inclusion Criteria:

* Diagnosed with knee OA as determined by ACR criteria: Knee pain and radiographic osteophytes and at least 1 of the following 2 items: Morning stiffness 30 minutes, Crepitus on motion, a VAS pain score of ≥ 30 mm for index knee at screening,

Exclusion Criteria:

* Weight of \> 125 kg, Inflammatory arthropathy including secondary OA (eg, degenerative arthritis in patients with rheumatoid arthritis) as confirmed by a rheumatologist or investigator, Diagnosis of a condition other than knee OA that, in the investigator's opinion, may cause or affect pain or pain assessment in the index knee; these conditions may include but are not limited to radiculopathy or neuropathy, vasculopathy, fibromyalgia or active depression, Subjects taking neuromodulatory agents (antiepileptics or antidepressants) used as analgesic therapy for neuropathic pain

Primary outcomes:
measure: Safety and tolerability as measured by subject incident of treatment-emergent adverse events, clinically significant changes in vital signs, physical examinations endpoints, clinical laboratory safety tests, and ECGs
timeFrame: from 197 days to 211 days
Secondary outcomes:
measure: Pharmacokinetics profile of AMG 403 including Tmax, AUClast and Cmax
timeFrame: from 197 days to 211 days
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Gow JM, Tsuji WH, Williams GJ, Mytych D, Sciberras D, Searle SL, Mant T, Gibbs JP. Safety, tolerability, pharmacokinetics, and efficacy of AMG 403, a human anti-nerve growth factor monoclonal antibody, in two phase I studies with healthy volunteers and knee osteoarthritis subjects. Arthritis Res Ther. 2015 Oct 8;17:282. doi: 10.1186/s13075-015-0797-9.
Clinical trial NCT02523807: Tremor Monitoring Device
Official title: Tremor Monitoring Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Essential Tremor
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
Collaborators: name: Technion, Israel Institute of Technology
First posted: 2015-08-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with tremor due to Parkinson's disease or Essential tremor will be included

Brief summary: Patients with tremor may have varying degrees of tremor at different times. The amplitude and frequency of tremor may change. The investigators observational study is intended to document this tremor.


Eligibility criteria: Inclusion Criteria:

* Patients with tremor due to Parkinson's disease or Essential tremor

Exclusion Criteria:

* Severe dementia

Primary outcomes:
measure: Maximum linear acceleration of the forearm.
timeFrame: Linear acceleration of the forearm will be measured for 15-60 minutes.
Secondary outcomes:
measure: Maximum angular velocity of the forearm.
timeFrame: Maximum angular velocity of the forearm will be measured for 15-60 minutes.
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Ilana Schlesinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00345007: Macular Function After Scleral Buckle
Official title: Assessment of Recovery of Macula Function After Successful Scleral Buckling Surgery for Rhegmatogenous Retinal Detachment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhegmatogenous Retinal Detachment
Keywords: Retinal detachment
Macular function
Multifocal electrophysiology
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2006-06-27
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Assess recovery of macula function after successful scleral buckling surgery for rhegmatogenous retinal detachment by using the multifocal ERG in the postoperative period i.e. recovery of functional integrity 2. Assess the relationship between the neurosensory retina and the retinal pigment epithelium/choriocapillaris after scleral buckling i.e. recovery of structural integrity 3. Assess if there is a difference between macula function postoperatively, in eyes with retinal detachments involving the macula and those that do not.

Detailed description: Patients with acute rhegmatogenous retinal detachments managed by scleral buckling surgery will be recruited into 3 groups. (Please see attached appendix A)

We define the area of the macula as the area within the temporal vascular arcades with the horizontal radius defined between the optic disc and the foveal centre.

Group A: Macula not detached Group B: Macula partially detached i.e. detachment stops within the macula Group C: Macula is totally detached

After scleral buckling surgery for the retinal detachment, the patients will be examined at Day 1, week 1, month1, 3 and 6. During these visits, they will be examined clinically, as well as undergo tests - refraction, colour vision (D-15) \& contrast sensitivity testing, OCT and multifocal ERG. (Please see attaced visit schedule).

Eligibility criteria: Inclusion Criteria:

* Acute rhegmatogenous retinal detachment undergoing scleral buckling surgery

Exclusion Criteria:

* Only eye patients
* Patients who undergo surgery which require use of intravitreal gases
* Patients who will not be able to cooperate for the mfERG and OCT testing
* Patients with macula hole detachments
* Fellow eye with poor vision resulting in inability to fixate for the mfERG

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Centre
name: Shu-Yen Lee, FRCSEd
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore National Eye Centre
name: Chong-Lye Ang, FRCOphth
role: STUDY_CHAIR
References:
Clinical trial NCT00627107: A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit
Official title: Study of the ReWalk Motorized Exoskeleton Suit That Enables Individuals With Lower Limbs Impairment to Walk and to Perform Other Basic Mobility Functions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paraplegia
SCI
Keywords: ReWalk, Paraplegia, SCI
Lead sponsor: ReWalk Robotics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The ReWalk enables people with lower limb disabilities to carry out routine ambulatory functions (stand, walk, climb stairs etc.). It can be used by people with disabilities such as spinal cord injury, brain injury, stroke, multiple sclerosis, cerebral palsy and other severe walking impairments. The device promises to restore the dignity of disabled persons, enabling them to work and improve their general health and quality of life, as well as significantly reduce medical and other related expenses.

Detailed description: The ReWalk comprises light wearable brace support suit, which integrates DC motors at the joints, rechargeable batteries, an array of sensors and a computer-based control system. It is snugly fitted on the body and worn underneath the clothing, if desired. ReWalk is a new realization of the Powered Exoskeleton concept, first tried about fifty years ago with no success. Employing an innovative, non-robotic design approach, it uniquely matches the user's capabilities with the control mechanisms. Upper-body movements of the user are detected and used to initiate and maintain walking processes. User stability and safety during ambulation is secured by concurrent use of safety aids such as crutches for walking and railing for stairs.

Eligibility criteria: Inclusion Criteria:

* Chronic (at least 6 months after injury) complete cervical(C7-8) or thoracic (T1-T12) spinal cord injury
* Age between 18-55
* Male and non-pregnant non-lactating female
* Regular use of RGO or bing able to stand up using a device (e.g. EasyStand)
* under 100 kg and between 155-200 cm of height

Exclusion Criteria:

* History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
* Severe concurrent medical diseases: infections, heart or lung, pressure sores
* Unstable spine or unhealed limbs or pelvic fractures
* Psychiatric or cognitive situations that may interfere with the study

Primary outcomes:
measure: Observation and subject feedback
timeFrame: 3 months
Secondary outcomes:
measure: subject tolerance
timeFrame: 3 months
Other outcomes:
Locations:
city: Tel-Hashomer
country: Israel
facility: Sheba Medical Center, Neurological Rehabilitation Department
Study officials:
affiliation: Sheba Medical Center
name: Gabi Zeilig, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01008007: Viusid in Adults With Acute Fever of Viral Etiology
Official title: Effect of VIUSID Administration on Adults With Acute Fever of Viral Etiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Fever of Viral Etiology
Keywords: Viusid
Dietary supplements
Acute fever
Viral etiology
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the safety and effect of Viusid (bags of 4 grams) administration in the treatment of acute fever of viral etiology as diagnosed by clinical, hematologic and serologic parameters. The duration of this open and randomized phase 2 clinical trial will be 6 days. The estimated number of persons with acute fever of viral etiology to be recruited and randomized for the study is 200. The primary outcome measure: platelet, leukocyte and granulocyte count will be assessed at the beginning and the end of the study.


Eligibility criteria: Inclusion Criteria:

* Acute fever of viral etiology with less than 72 hours of progression
* Signed informed consent.

Exclusion Criteria:

* Patients under treatment with other antioxidants.
* Inability to swallow the content of Viusid bags

Primary outcomes:
measure: The platelet count improvement at 6 days (end of the treatment)
timeFrame: 6 days
measure: The leukocyte count improvement at 6 days (end of the treatment)
timeFrame: 6 days
measure: The granulocyte count improvement at 6 days (end of the treatment)
timeFrame: 6 days
Secondary outcomes:
measure: Clinical symptoms disappear during the Viusid administration (6 days).
timeFrame: 6 days
measure: Adverse effects during treatment
timeFrame: 6 days
measure: Hemoglobin level improvement
timeFrame: 6 days
measure: Hematocrit level improvement at 6 days (end of the treatment)
timeFrame: 6 days
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Salvador Allende" Clinical-Surgical Hospital
state: Havana
Study officials:
affiliation: "Salvador Allende" Clinical-Surgical Hospital
name: Mayra R Carrasco García, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06315907: Development and Validation of a Brief Food Noise Questionnaire
Official title: Development and Validation of a Brief Food Noise Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eating Behavior
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: WW International Inc
First posted: 2024-03-18
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be adults (18 years of age or older) residing in the United States.

Brief summary: The purpose of the research is to develop and test the reliability and validity of a brief questionnaire to measure food noise.

Detailed description: Currently and to our knowledge, there are no validated questionnaires to assess food noise. The purpose of this study is to develop and validate a brief food noise questionnaire. A total of 400 participants will be asked to complete the new food noise questionnaire. A subsample will also be asked to complete the questionnaire a second time to evaluate test-retest reliability. A separate subsample will also complete additional questionnaires to test convergent and discriminant validity.

Eligibility criteria: Inclusion Criteria:

* This study is open to adults (aged 18 years and above) who reside in the United States.

Exclusion Criteria:

* Individuals who do not provide informed consent will not progress to the survey questions
* Individuals who are currently participating in a weight loss program
* Individuals who have a BMI lower than 18.5 kg/m2

Primary outcomes:
measure: Scores on the food noise questionnaire
timeFrame: 30-45 minutes to complete the questionnaires
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
References:
Clinical trial NCT03266107: Study of Basivertebral Nerve Ablation Treatment of Chronic Low Back Pain
Official title: A Prospective, Open-Label, Single-Arm Study of Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Vertebrogenic Low Back Pain
Lead sponsor: Relievant Medsystems, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-29
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, single arm, open label, multi-center study to evaluated the effectiveness of intraosseous basivertebral nerve radiofrequency ablation using the Intracept System.

Detailed description: This is a prospective, open-label, single-arm study of patients diagnosed with vertebrogenic low back pain for a minimum of 6 months with conservative care. Participants will receive the Intracept System procedure to ablate the basivertebral nerve within the vertebral body. Treatment is performed on all vertebral bodies with Modic type 1 or type 2 changes on MRI from L3-S1.

Eligibility criteria: Inclusion Criteria:

* Skeletally mature subjects at least 25 years of age
* Chronic low back pain for at least 6 months
* Failure to respond to at least 6 months of non-operative conservative management
* Oswestry Disability Index (ODI) at least 30 points
* Modic changes Type 1 or 2

Exclusion Criteria:

* Current or history of vertebral cancer or spinal metastasis
* History of a fragility fracture
* Any back pathology related to trauma, evidence of vertebral compression fracture or other spinal pathology that could affect assessment of response to back pain
* Disc extrusion or protrusion

Primary outcomes:
measure: Oswestry Disability Index (ODI) - 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Visual Analog Scale (VAS) - 3 Months
timeFrame: 3 Months
measure: ODI Responder Rate - 3-Month
timeFrame: 3 Months
measure: VAS Responder Rate - 3 Month
timeFrame: 3 Months
measure: ODI -12 Months
timeFrame: 12 Months
measure: VAS - 12 Month
timeFrame: 12 Months
measure: ODI Responder Rate - 12-Month
timeFrame: 12 Months
measure: VAS Responder Rate - 12 Months
timeFrame: 12 Months
measure: VAS Reduction 50% or More - 12 Month
timeFrame: 12 Months
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Austin
country: United States
facility: Seton Spine and Scoliosis Center
state: Texas
Study officials:
affiliation: Independent
name: Eeric Truumees, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Independent
name: Kevin Macadaeg, MD
role: PRINCIPAL_INVESTIGATOR
References: