louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02516319: Liver Function Assessment - Feasibility and Dosing Study
Official title: A Feasibility Study to Determine an Adequate Dose of ICG for the Liver Function Assessment System in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hepatic Failure
Lead sponsor: Cardiox Corporation
Sponsor class: INDUSTRY
First posted: 2015-08-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to 1) determine the feasibility of using Cardiox Liver Function Assessment System (LFA) to measure indocyanine green (ICG) clearance; 2) determine an adequate dose based on LFA technology and 3) determine an adequate time period for LFA determination.

Detailed description: Four cohorts of subjects will be enrolled. The fist two cohorts will receive fixed doses of ICG dye (2.5 mg, 5.0 mg, 7.5 mg, 10.0 mg) followed by 20 minutes of LFT monitoring. The final two cohorts will receive weight based doses of ICG dye (0.1 mg/kg, 0.5 mg/kg) followed by 20 minutes of LFT monitoring. Additionally the final two cohorts will have serial blood draws before the ICG dose and at 5, 10, 15 and 20 minutes post ICG dose.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects, aged 18 to 75 years, inclusive
* Informed consent documentation understood and signed.

Exclusion Criteria:

* Known allergy or sensitivity to the ICG or to iodide contrast dye
* Pregnant women or those nursing babies

Primary outcomes:
measure: ICG dye detection using the LFT system compared to serial blood sampling ethods.
timeFrame: 20 minutes post ICG dose
Secondary outcomes:
measure: ICG fluorescence detection at the scaphoid fossa of the ears
timeFrame: 20 minutes post ICG dose
measure: Repeatability of the Cardiox LFA system to detect the ICG fluorescence in the same subjects over time.
timeFrame: 20 minutes post ICG dose
Other outcomes:
measure: Adverse-event recording
timeFrame: Two hours post ICG dose
measure: Physical Examination
timeFrame: Up to one hour post ICG dose
measure: Blood pressure
timeFrame: Up to one hour post ICG dose
measure: Heart rate
timeFrame: Up to one hour post ICG dose
measure: Respiration
timeFrame: Up to one hour post ICG dose
Locations:
Study officials:
affiliation: Cardiox Corporation
name: Michael W Jopling, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00827619: Zilver® Flex™ Vascular Stent Study
Official title: Evaluation of the Zilver® Flex™ Vascular Stent in the Above-the-Knee Femoropopliteal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease (PAD)
Keywords: Peripheral Arterial Disease
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2009-01-23
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to evaluate the long-term effectiveness of treatment of de novo or restenotic lesions of the above-the-knee femoropopliteal artery using the Zilver® Flex™ Vascular Stent which has received the CE mark for commercial use. The study is designed as a single arm non-randomized post-approval study.


Eligibility criteria: Inclusion Criteria:

* Patients who are at least 18 years old and have at least 1 stenotic atherosclerotic lesion of the above-the-knee femoropopliteal artery may be considered for enrollment.
* To be enrolled in the study, the lesion must be the appropriate size and and no prior stent in the target vessel may be present.

Exclusion Criteria:

* Patient is \< 18 years of age.
* Patient is pregnant or breast-feeding.
* Patient is simultaneously participating in an investigational drug or device study. The patient must have completed the follow-up phase for the primary endpoint of any previous study at least 30 days prior to enrollment in this study.
* Patient has had previous stenting of the target vessel.
* Patient has a medical condition or disorder that would limit life expectancy to less than 1 year or that may cause noncompliance with the protocol or confound the data analysis.
* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.
* Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.

Primary outcomes:
measure: Primary patency of the treated lesion within the superficial femoral artery
timeFrame: 1 year after patient enrollment
Secondary outcomes:
measure: Procedural success and primary-assisted and secondary patency, thrombosis/total occlusion rate, clinical improvement, and functional status improvement
timeFrame: 1 year after patient enrollment
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg
Study officials:
affiliation: Universitatsklinikum Magdeburg
name: Jens Ricke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05954819: Effect of Patient Education on Healthy Lifestyle Behaviors and Diabetes Self-management in Diabetics
Official title: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Myocardial Infarction
Keywords: Diabetes
Patient education
Diabetes self-management
Myocardial infarction
Healthy lifestyle behaviors
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effect of planned education given to individuals with diabetes mellitus who had myocardial infarction on healthy lifestyle behaviors and diabetes self-management.

Detailed description: Many coronary heart patients have diabetes. For this reason, it is thought that patients need education in order to gain healthy lifestyle behaviors and to provide self-management of diabetes, which is a major risk factor for coronary artery disease. When the literature was examined, no study could be found that focused on diabetes patients with myocardial infarction and emphasized the importance of patient education. It is thought that this study will make an important contribution in terms of patient education to be given to individuals with diabetes mellitus who have had myocardial infarction.

Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* No advanced hearing and vision problems,
* Able to speak and understand Turkish,
* Easy to communicate,
* Literate,
* Agreeing to participate in the research voluntarily,
* Hospitalized due to myocardial infarction in the last month,
* Have stayed in the intensive care unit for at least 24 hours,
* No chest pain
* Patients who have been diagnosed with Type 2 Diabetes Mellitus for at least one year

Exclusion Criteria:

* Sedative or narcotic analgesic drug treatment,
* Use of antipsychotic medication
* Patients receiving Continous Positive Airway Pressure treatment,
* Patients with cognitive dysfunction

Primary outcomes:
measure: Change of Healthy Lifestyle Behaviors
timeFrame: Change from Baseline Healthy Lifestyle Behaviors at 4 Weeks
measure: Change of Diabetes Self-Management
timeFrame: Change from Baseline Diabetes Self-Management at 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
Study officials:
affiliation: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
name: Arzu Erkoc
role: STUDY_DIRECTOR
References:
Clinical trial NCT05761119: Feasibility of an Early Initiated Physiotherapy Intervention Among Patients With Deep Vein Thrombosis.
Official title: Feasibility of an Early Initiated Physiotherapy Intervention Among Patients With Deep Vein Thrombosis.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deep Vein Thrombosis
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2023-03-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The project will investigate the feasibility of a physiotherapy intervention for patients diagnosed with deep vein thrombosis for whom a physiotherapy intervention is not currently part of clinical practice in Denmark. Specifically, the project will investigate if an early-initiated physiotherapy intervention for patients who are admitted acutely with first-time deep vein thrombosis (DVT), can be carried out and is experienced as valuable for the patients.

Detailed description: This study aims to investigate whether it is possible for patients diagnosed with DVT to complete early mobilization combined with progressive walking during their hospitalization and the first month after discharge.

This study is twofold. Part one is a clinical cohort study and will investigate the feasibility using quantitative outcomes. Part two is a qualitative study using interviews to investigate the patients' experiences with and attititudes towards a physiotherapy guided intervention of early mobilization combined with progressive walking during their hospitalization and one month after discharge to their own home.

If the physiotherapy intervention is deemed feasible and acceptable, a future randomized controlled trial will investigate the effect of the intervention on quality of life.

Eligibility criteria: Inclusion Criteria:

1. 18 years or above
2. First time lower extremity DVT
3. Hospitalized at the Emergency Department

Exclusion Criteria:

1. Patients without a Danish social security number
2. Terminal patients
3. Patients who do not understand or speak Danish

Primary outcomes:
measure: Participation
timeFrame: Baseline to one month
measure: Dropout
timeFrame: Baseline to one month
measure: Respond rate regarding questionnaire on quality of life
timeFrame: Baseline to one month
measure: Adverse events
timeFrame: Baseline to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre Hospital
state: Region Hovedstaden
city: Slagelse
country: Denmark
facility: Department of Physiotherapy, Næstved-Slagelse-Ringsted Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Helle Juul-Larsen, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre University Hospital
name: Mette Merete Pedersen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05991219: Screening and Secondary Prevention Rheumatic Heart Disease Study
Official title: Screening and Secondary Prevention Rheumatic Heart Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatic Heart Disease
Lead sponsor: National Institute of Cardiovascular Diseases, Pakistan
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 5000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Age group 10-30 years. Screening in rural communities in Sindh including very low income areas outside Karachi. Schools (free government schools in low income areas) and patient point of contact locations such as National Institute of Cardiovascular Diseases Pakistan Satellite centers (10) and chest pain units (24) will also be utilized. Family members of patients with known rheumatic heart disease will also be screened.

Brief summary: After basic clinical screening including history and physical, Point of care ultrasound will be performed to look at Mitral, Aortic and Tricuspid Valves for regurgitation or stenosis. For patients with confirmed Rheumatic heart disease (RHD), treatment and referral depending on stage of disease. Antibiotic prescription could be shifted to community health workers delivering preventive medications via practical clinical algorithms, diagnostic tools, availability of appropriate antibiotics, and supportive supervision. Patients will have repeat imaging at 2 years and 5 years to look at the outcome of delayed progression of valve disease.

Detailed description: Screening for RHD should be carried out since it is a major health concern that has been shown to have a treatable and detectable latent stage that can be diagnosed using a simple sensitive test (point of care ultrasound) and early treatment (secondary prevention using antibiotic prophylaxis) can provide a better outcome (slow progression of disease) in a cost effective way. The investigators aim to study the Incidence and Prevalence of RHD in community and school settings and aim to intervene depending on the stage the disease is picked up in.

Eligibility criteria: Inclusion Criteria:

* Rural communities in Sindh

Exclusion Criteria:

* Refused to participate in the study

Primary outcomes:
measure: Rheumatic heart disease
timeFrame: At the time of screening echocardiogram
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Cardiovascular Diseases (NICVD)
state: Sindh
Study officials:
affiliation: National Institute of Cardiovascular Diseases
name: Sabha Bhatti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02668419: Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use
Official title: Neuromuscular Electrical Stimulation Improves Exercise Tolerance in Patients With Advanced Heart Failure on Continuous Dobutamine Use - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Ventricular Dysfunction, Left
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2016-01-29
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether neuromuscular electrical stimulation can improve exercise tolerance for patients with heart failure and continuous dobutamine use in a hospital.


Eligibility criteria: Inclusion Criteria:

* Advanced heart failure (Stage D - Left ventricle ejection fraction \<30%)
* New York Heart Association class III-IV
* Standard medical therapy for heart failure management
* Continuous inotropic infusion

Exclusion Criteria:

* Unstable angina pectoris
* Recent (6 months) acute coronary syndrome
* Arrythmias
* Chronic renal failure
* Diabetes Mellitus
* Peripheral vascular diseases
* Inability to walk

Primary outcomes:
measure: Functional capacity evaluated using the 6-minute walk test (6MWT)
timeFrame: Change from assessment at admission and at patient discharge
Secondary outcomes:
measure: Change in the intravenous inotropic support dosage
timeFrame: Change from the first day of the protocol and patient discharge
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Federal University of Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Patricia Forestieri, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06086119: Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers
Official title: Quality of Life and Voice Perception in Patients Laryngoctomized Phonatory Wearers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Larynx Cancer
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: San Giovanni Addolorata Hospital
name: Azienda Policlinico Umberto I
First posted: 2023-10-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.

Brief summary: Prospective, multicenter observational study involving patients who will undergo total laryngectomy surgery and placement of phonatory prosthesis.


Eligibility criteria: Inclusion Criteria:

* Patients who will undergo laryngeal demolition surgery, total laryngectomy, who agree to phonatory prosthesis placement
* Patients who have undergone previous total laryngectomy surgery and intend to undergo placement of phonatory prosthesis.
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* Patients who have not undergone demolitive surgical treatment by total laryngectomy or who do not accept the placement of phonatory prosthesis.
* Patients who are unable to complete questionnaires/follow the rehabilitation pathway

Primary outcomes:
measure: evaluate the patient's quality of life and voice perception underwent surgery for the placement of a voice prosthesis
timeFrame: Enlistment period: 2 years Total duration of the study: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT02711319: Non-invasive Brain Stimulation for Gait Improvement in Patients With Spinal Cord Injury
Official title: Non-invasive Brain Stimulation in SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Functional Improvement
Lead sponsor: Institut Guttmann
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2016-03-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to optimize the functional outcome in early phase of gait rehabilitation in subacute incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger improvement of gait function than with physical therapy alone.

Detailed description: Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive and painless procedure to modulate cortical excitability of motor areas and induce changes over the descending corticospinal output. This modulation may be useful to promote active recovery of motor function and to obtain functional benefit from gait rehabilitation. Through the use of repetitive high-frequency rTMS, improvement has been reported in motor and sensory functions measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS), and time to complete a peg-board task in four chronic incomplete cervical SCI patients.

Physical therapy aims to improve function of both undamaged and also, as far as possible, damaged neuronal structures. However, 'reorganization' of neuronal circuits is the target of specific training approaches. Therefore, the challenge is to guide CNS plasticity in order to optimize the functional outcome for a given individual. Hypothesized was that high-frequency rTMS coupled with gait training can improve motor recovery in the lower extremities and locomotion in incomplete SCI patients to a greater degree than sham stimulation.

Eligibility criteria: inclusion criteria:

1. had subacute motor incomplete SCI (AIS-C or D),
2. candidate for gait rehabilitation with Lokomat® after cervical or thoracic SCI;
3. stable medical treatment at least one week before and during the study;
4. without limitation of passive range of movement in joints
5. agreed to participate after signing a written informed consent form.

exclusion criteria:

1. unstable clinical state
2. severe spasticity (MAS\>=3)
3. disagreed to sign consent form

Primary outcomes:
measure: ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)
timeFrame: Change from Baseline 10MWT at 4 and 8 weeks
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Change from Baseline MAS at 4 weeks
measure: --Total motor score from upper (UEMS) and lower extremities (LEMS)
timeFrame: Change from Baseline 1UEMS and LEMS at 4 and 8 weeks
measure: Walking Index for SCI (WISCI) II
timeFrame: Change from Baseline WISCI-II at 4 and 8 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00869219: Comparison of Pain Sensation During Single Use of Two Topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Official title: Phase 4 Study of Topical NSAID for Ophthalmologic Use: Pain Measurement After First Drop.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: Pain
Pain after eyedrops
Lead sponsor: Santa Casa de Misericordia de Santos
Sponsor class: OTHER
First posted: 2009-03-25
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different case reports are showing that depending on the drug used for eye drops, it might provoke a painful sensation. Actually two leading NSAIDs are used in ophthalmology. This study is intended to provide information about this parameter concerning these two drugs.


Eligibility criteria: Inclusion Criteria:

* Patient over 21 years old
* No ocular surface pathology
* Eligible for cataract surgery

Exclusion Criteria:

* Any other eye pathology other than cataract

Primary outcomes:
measure: Pain after instilation
timeFrame: 5 min
Secondary outcomes:
Other outcomes:
Locations:
city: Santos
country: Brazil
facility: Santa Casa de Misericordia de Santos
state: Sao Paulo
Study officials:
affiliation: SCMS
name: Gustavo T Grottone, MD, MBA,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: SCMS
name: João C Grottone, MD, MBA
role: STUDY_CHAIR
References: