louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01384175: Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl
Official title: Epidural Anesthesia and Postoperative Analgesia With Ropivacaine and Fentanyl in Off-pump Coronary Artery Bypass Grafting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Epidural Analgesia
OPCAB
PCEA
Lead sponsor: Northern State Medical University
Sponsor class: OTHER
Collaborators: name: University of Tromso
First posted: 2011-06-28
Enrollment: 93
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: The aim of the present study was to assess the efficacy of thoracic epidural anesthesia followed by postoperative epidural infusion and patient-controlled epidural analgesia with ropivacaine/fentanyl in off-pump coronary artery bypass grafting

Detailed description: Ninety-three patients were scheduled for off-pump coronary artery bypass (OPCAB) under propofol/fentanyl anesthesia. Day before surgery patients were asked for informed consent and randomized into three postoperative analgesia regimens aiming at a visual analog scale (VAS) score \<30 mm at rest. The control group (n=31) received intravenous fentanyl 10 µg/ml postoperatively 3-8 mL/h. After placement of an epidural catheter at the level of Th2-Th4 before OPCAB, a thoracic epidural infusion (EI) group (n=31) received epidural anesthesia (EA) intraoperatively with ropivacaine 0.75% 1 mg/kg and fentanyl 1 µg/kg followed by continuous EI of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL postoperatively. The patient-controlled epidural analgesia (PCEA) group (n=31), in addition to EA and EI, received PCEA (ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min) postoperatively. Hemodynamics and blood gases were measured throughout 24 h after OPCAB.

Eligibility criteria: Inclusion Criteria:

* presence of coronary artery disease
* ASA II-III
* elective off-pump coronary artery bypass

Exclusion Criteria:

* age \< 18 years
* severe valve dysfunction or peripheral vascular disease
* simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)
* transfer to CPB during surgery

Primary outcomes:
measure: Duration of postoperative mechanical ventilation
timeFrame: Participants will be followed for the duration of mechanical ventilation, an expected average of 6 hours
Secondary outcomes:
measure: Hemodynamic stability
timeFrame: All period of operation and during 24 hours postoperatively
Other outcomes:
Locations:
city: Arkhangelsk
country: Russian Federation
facility: Dep. of Anesthesiology, Northern SMU
Study officials:
affiliation: Northern State Medical University
name: Mikhail Y Kirov
role: STUDY_DIRECTOR
References:
citation: Kirov MY, Eremeev AV, Smetkin AA, Bjertnaes LJ. Epidural anesthesia and postoperative analgesia with ropivacaine and fentanyl in off-pump coronary artery bypass grafting: a randomized, controlled study. BMC Anesthesiol. 2011 Sep 18;11:17. doi: 10.1186/1471-2253-11-17.
Clinical trial NCT03958175: The Alouette Test in Parkinson Disease
Official title: Screening for Reading Difficulties in Parkinson's Disease: An Evaluation of the Alouette Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had Parkinson's Disease

Brief summary: Reading disorders in Parkinson's Disease (PD) are poorly evaluated due to the lack of validated tests to screen for them. They are often attributed to hand tremors associated with the disease. In this study, the investigating team evaluated the "alouette test" validated for dyslexia screening, in PD by comparing the results to healthy patients.


Eligibility criteria: Inclusion Criteria:

* Patients with Parkinson's Disease
* Montreal Cognitive Assessment (MoCA) test \> 20

Exclusion Criteria:

* Patient's with supranuclear Palsy
* Other neurologic disease
* Any ophthalmologic disease
* Presence of a nystagmus
* Visual acuity \< 0.6

Primary outcomes:
measure: Score on the Alouette test
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: Thibaud Mathis, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06162975: The Surveillance Clinical Study of Rickettsiosis
Official title: The Surveillance (Non-interventional, Observational) Clinical Study of Rickettsiosis Caused by a New Genotype of Rickettsia in the Altai Republic, Russian Federation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rickettsiosis
Lead sponsor: Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.

Brief summary: The purpose of this surveillance (non-interventional) clinical study is to genotype the causative agents of rickettsiosis in biological samples of patients from the Altai Republic, Russian Federation. This is a solely observational study in the patients with diagnosed or suspected tick-borne rickettsioses, with no intervention to the routine treatment and diagnostic process. During the study the medical history, diseases progress and symptoms, as well as treatments are being registered in individual case report forms. The rests of the samples used for standard diagnostics (plasma, or serum, and/or swabs of the tick bite site) are being collected and afterwards will be analyzed for a new rickettsia type. These data will be compared to the medical history and symptoms of the patients in order to identify clinical pattern specific for the new rickettsia type. Informed consents from all patients or their legal representatives are being collecting. The study was approved by the local ethical committee.


Eligibility criteria: Inclusion Criteria:

* Written patient's informed concent for study participation;
* Male and female patients of any age with diagnosed or suspected tick-born rickettsioses.

Exclusion Criteria:

- Unwillingness to participate in the study by any reason.

Primary outcomes:
measure: Genotype the causative agents of rickettsiosis
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gorno-Altaïsk
country: Russian Federation
facility: Altai Republic Center for HIV prophylaxis and treatment
state: Altai Republic
Study officials:
References:
Clinical trial NCT03236675: Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
Official title: Detection of Either the EML4-ALK Gene Rearrangements or the T790M EGFR Mutation in the Plasma of Advanced NSCLC Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Exosome Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Demonstrate feasibility of detection of EML4-ALK fusion transcripts and T790M EGFR mutation from exosomes in the circulation of Non-Small Cell Lung Cancer (NSCLS) patients.

Detailed description: The goal of this study is two-fold: 1) Demonstrate feasibility of detection of EML4-ALK fusion transcripts in the circulation of NSCLC patients positive for ALK on tissue analysis, using an institutionally accepted assay; 2) Demonstrate feasibility of detection of T790M EGFR mutation in the circulation of NSCLC patients positive for T790M on tissue analysis, using an institutionally accepted assay.

Eligibility criteria: Inclusion Criteria:

1. Participants must have histologically confirmed NSCLC, stage IIIB- IV, and have tested positive for the presence of EML4-ALK on tissue specimen, fresh or archived, using an institutionally accepted assay.
2. Age of 18 years or older.
3. Participants are being considered for ALK-directed therapy or have progressed on EGFR TKI treatment.
4. Participants must have hemoglobin \> 10 mg/dL.
5. Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

1. Hepatitis (all types) in patient's medical record
2. HIV documented in patient's medical record
3. Hemoglobin \< 10 mg/dL
4. Less than 18 years of age
5. Histologically confirmed NSCLC Stage I-IIIA
6. Tested negative for the presence of EML4-ALK and T790M EGFR on tissue

Primary outcomes:
measure: ALK mutation by tissue assay.
timeFrame: Two years
measure: T790M EGFR mutation by tissue assay
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
affiliation: Exosome Diagnostics, Inc.
name: Roger Tun
role: STUDY_DIRECTOR
References:
Clinical trial NCT03292575: Study of the Follow-up of Stroke Treated With Anticoagulants
Official title: Prevention of Cardio-embolic Stroke Using Anti-vitamin K and Direct Oral Anticoagulants. A Model of Action in Burgundy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 441
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with stroke resulting from occlusion of a cerebral artery (cerebral infarction) with a clot detached from the heart that exhibits an arrhythmia by Auricular Fibrillation or the occurrence of intracerebral hemorrhage

Brief summary: Stroke is a major public health problem as it is very frequent (140,000 cases/year in France), and very serious (leading cause of death, 2nd leading cause of dementia, 3rd leading cause of handicap). Ischemic cardio-embolic stroke accounts for around 25% of ischemic strokes, and ischemic cardio-embolic stroke in a context of cardiac arrhythmia due to atrial fibrillation (CAAF) is the leading non-atheromatous cause. The aim of this study is to optimise the secondary prevention of CAAF-related stroke identified at the University Hospital of Dijon Burgundy in the framework of the recommendations of the '2010-2014 stroke plan' and the Compulsory Consultation at the 6th month (Directive DGOS//2015/262 of the 3rd August 2015)


Eligibility criteria: Inclusion Criteria:

* patients managed for stroke at the stroke unit of Dijon University Hospital for CAAF-related cardio-embolic stroke

Exclusion Criteria:

* NA

Primary outcomes:
measure: rate of stroke recurrences
timeFrame: 12 months after inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01337375: A Study of the Pharmacokinetics And Pharmacodynamics of Intravenously Administered Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C And Previous Non-Response to Pegylated Interferon And Ribavirin Combination Therapy
Official title: Pharmacokinetics and Pharmacodynamics of Intravenous Administration of Pegylated Interferon-2a in Patients With Chronic Hepatitis C and Previous Non-response to Standard Combination Therapy With Pegylated Interferon and Ribavirin (Intervention Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-18
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: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this randomized, cross-over, open label study the correlation of Pegasys (peginterferon alfa-2a) pharmacokinetics after intravenous (iv) and subcutaneous (sc) administration with viral load and viral kinetics will be investigated in patients with chronic hepatitis C genotype 1 who were non-responders to previous standard combination therapy with pegylated interferon and ribavirin. Patients will be randomized to receive either weekly or twice weekly Pegasys iv or sc for 2 weeks, crossing over to the other mode of administration after a washout period of 6 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult caucasian patients, 18 - 70 years of age
* Hepatitis C, genotype 1
* Non-responder to previous anti-HCV therapy with peginterferon alfa and ribavirin
* Compensated liver disease (Child-Pugh class A) for \>/= 24 months before baseline
* Positive for anti-HCV for \> 6 months, with detectable serum HCV-RNA

Exclusion Criteria:

* Treatment-naïve or responder to previous therapy
* HCV infection other than genotype 1
* Positive for Hepatitis A, Hepatitis B or HIV infection at screening
* Chronic Hepatitis of other than HCV origin
* Decompensated liver disease (Child-Pugh class B or C)
* Therapy with systemic antiviral, antineoplastic or immunomodulatory agents in the 6 months prior to study
* Clinically relevant retina disorder
* Pregnant or lactating women and male partners of pregnant women

Primary outcomes:
measure: HCV RNA levels (IU/ml, COBAS TaqMan HCV Test) in correlation with area under the plasma concentration-time curve (AUC) after sc and iv administration
timeFrame: 11 months
Secondary outcomes:
measure: Evaluation of predictors of response to i.v. treatment
timeFrame: 11 months
measure: Effect of waist to hip ratio on pharmacokinetics
timeFrame: 11 months
measure: Effect of waist to hip ratio on viral response
timeFrame: 11 months
measure: Incidence of adverse events
timeFrame: 11 months
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Frankfurt Am Main
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Leipzig
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00166959: Reliability and Validity of Modified Postural Assessment Scale for Stroke Patients and the Application of This Scale on Early Detection of Patients With Stroke at High Risk of Falls
Official title: Reliability and Validity of Modified Postural Assessment Scale for Stroke Patients and the Application of This Scale on Early Detection of Patients With Stroke at High Risk of Falls
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Stroke patients
Falls
Reliability
Validity
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: The purposes of this study are to investigate the reliability and validity of the modified Postural Assessment Scale for Stroke Patients (mPASS) and its applications in early detection of fall-prone patients.

The intraclass correlation coefficient will be used to examine the intra-rater reliability, inter-rater reliability, and the Cronbach's alpha will be used to examine the internal consistency of the 16 items of mPASS.

Detailed description: Due to the impaired balance function, patients with stroke show high incidence of falls. Impaired postural stability has been shown as one of the primary risk factors of falls in these patients. Research has shown that patients who have moderate level of mobility and stability are more likely to fall than those who have very good or very poor mobility and stability. Therefore, there is an urgent need for physical therapists, who are used to play an important role in improving balance function of patients with stroke, to be able to early detect stroke patients who are at high risk of falls, and to implement fall prevention training and education on these patients. However, to date, there is not any clinical assessment scale that can be used for early detection of fall-prone stroke patients.

Eligibility criteria: Inclusion Criteria:

* between 30 and 80 years old
* first onset or recurrent stroke as a result of a single cerebral vascular accident (ischemic or hemorrhage stroke)
* ever received medical or rehabilitation therapies at National Taiwan University Hospital
* being willing to take the clinical assessments and accept the vedio record

Exclusion Criteria:

* having unstable vital sign, unconsciousness, or having serious cognitive, perception, and language impairment, and being unable to follow the order of the experimenter
* having other neurological diseases(ex. Parkinson's disease or cerebellar disease etc.), or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases those will influence the balance performance other than stroke

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Chein-Wei Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02361359: Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty
Official title: Preoperative Catastrophizing Predicts Pain Outcome After Shoulder, Knee and Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Chronic Pain
Catastrophization
Keywords: Arthroplasty
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who undergo joint arthroplasty (shoulder, hip ou knee) for osteoarthritis

Brief summary: Psychologic status is associated with poor outcome after joint arthroplasty and perhaps chronic pain. To enhance the therapeutic effect of a psychologic intervention, the specific disorders or pain-related beliefs that contributed to chronic pain should be identified. We therefore determined whether specific psychologic disorders (depression, anxiety disorder) or health-related beliefs (self-efficacy, pain catastrophizing) are associated with chronic pain after joint arthroplasty for osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* joint arthgroplasty (shoulder, hip ou knee)
* osteoarthritis

Exclusion Criteria:

* previous surgery in the same joint

Primary outcomes:
measure: Pain score
timeFrame: 1 year postoperatively
Secondary outcomes:
measure: Functional score
timeFrame: 1 year postoperatively
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hospital Ambroise Paré Paris
Study officials:
References:
citation: Hardy A, Sandiford MH, Menigaux C, Bauer T, Klouche S, Hardy P. Pain catastrophizing and pre-operative psychological state are predictive of chronic pain after joint arthroplasty of the hip, knee or shoulder: results of a prospective, comparative study at one year follow-up. Int Orthop. 2022 Nov;46(11):2461-2469. doi: 10.1007/s00264-022-05542-7. Epub 2022 Aug 23.
Clinical trial NCT00151359: Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
Official title: Clinical Trials Stage of 'SoleSensor': A Balance-Enhancing Shoe Insert.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensation Disorder
Lead sponsor: Wilfrid Laurier University
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2005-09-08
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Our research has shown that pressure sensation from the soles of the feet (plantar mechanoreceptors) plays an important role in controlling several key aspects of balancing reactions, particularly during compensatory stepping . As a result, age-related loss of plantar pressure sensation, which is very common, can lead to impaired control of these reactions. However, we have shown that it is possible to compensate for balance impairments resulting from this loss of sensation by using special footwear insoles to facilitate sensation from the perimeter of the sole. To date, we have demonstrated the feasibility of this approach in laboratory studies, and we have obtained a U.S. patent for the design concept. However, it remains to be determined whether the benefits of the footwear persist over the long term, or whether there is a habituation of the effect. Also, we need to determine whether there are any practical problems associated with wearing such footwear, e.g. due to discomfort or irritation of the skin.


Eligibility criteria: Inclusion Criteria:

* Aged 65 to 75 years

Exclusion Criteria:

* Any neurological or musculoskeletal ailments that affect their balance
* Any drugs that affect balance

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: WLU Biomechanics Laboratory
state: Ontario
Study officials:
affiliation: Wilfrid Laurier University
name: Stephen D Perry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Studies In Aging, Sunnybrook & Women's
name: Brian E Maki, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Studies In Aging, Sunnybrook & Women's
name: Geoff R Fernie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perry SD, Santos LC, Patla AE. Contribution of vision and cutaneous sensation to the control of centre of mass (COM) during gait termination. Brain Res. 2001 Sep 14;913(1):27-34. doi: 10.1016/s0006-8993(01)02748-2.