louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01477190: Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
Official title: Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program.

Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).

Detailed description: This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the ERAS program.

Eligibility criteria: Inclusion Criteria:

* patients scheduled to undergo laparoscopic colonic resection

Exclusion Criteria:

* patients who have trouble to understand, read or communicate either in French or in English
* dementia
* patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
* patients suffering from severe cardiac or respiratory disease (status ASA IV)
* patients suffering from metastatic carcinoma
* patients who have a history of chemoradiation within the six months preceding surgery
* morbid obesity
* contraindication to spinal analgesia

Primary outcomes:
measure: postoperative pain
timeFrame: daily during hospitalization up to 3 days after the operation
Secondary outcomes:
measure: opioid consumption
timeFrame: daily during hospitalization up to 3 days after the operation
measure: opioid side effects
timeFrame: daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Franco Carli, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05015790: Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety
Official title: Effect of VIrtual Reality Spectacles on the Management of Pain and Anxiety During the Insertion of the Implantable Catheter Chamber in the Operating Theatre in Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Keywords: Virtual reality, pain, cancer
Lead sponsor: Poissy-Saint Germain Hospital
Sponsor class: OTHER
First posted: 2021-08-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an ICP in the operating room under local anesthesia in the patient newly diagnosed with cancer

Detailed description: The insertion of an implantable catheter chamber (ICH) is indicated in the case of prolonged or repeated infusions, particularly when the products injected are toxic to the venous walls, as is the case with cancer chemotherapy.

The insertion of a ICH is carried out in the operating theatre, usually under local anaesthesia. Although this operation is potentially painful and stressful, the question of its perception by the patient has not yet been addressed, nor the relevance of using non-invasive devices to alleviate the pain felt by the patient.

Among the proposals, virtual reality glasses Bliss Solution would be likely to improve patient management when a ICH is performed under local anaesthesia in the operating theatre.

The evaluation will be made on the contribution of the use of the Bliss Solution virtual reality glasses in the management of pain during the installation of an ICH under local anesthesia in the operating room.

Eligibility criteria: Inclusion Criteria:

* Adult patient over 18 years of age
* Patient suffering from a cancerous pathology
* Patient taken care of for the installation of the ICH

Exclusion Criteria:

* Patient does not speak and understand French
* Patient who has had a previous ICH installation
* Patient with cognitive impairment
* Patient with pain perception disorder

Primary outcomes:
measure: The main assessment criterion is measured using the Visual Analogue Scale (VAS), which allows a self-assessment of the level of pain felt by the patient using a ruler rated from 1 to 10.
timeFrame: one year
Secondary outcomes:
measure: The evaluation criterion will be measured on the Hamilton scale measuring anxiety during an operation.
timeFrame: one year
Other outcomes:
Locations:
city: Poissy
country: France
facility: CH Poissy st Germain
Study officials:
affiliation: CHI Poissy
name: valerie M LOIZEAU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03007290: Clinical Usefulness of Therapeutic Drug Monitoring of Colistin in Patients Treated With Colistin.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multidrug-resistant Gram-negative Bacteria Infection
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old.
* Those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection.

Exclusion Criteria:

* Those who received colistin therapy less than 48 hours
* Those who received colistin therapy through the bronchus

Primary outcomes:
measure: AKI
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
measure: Death
timeFrame: Through study completion, an average of 1 month
measure: Negative conversion rate
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
Clinical trial NCT04123990: Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease
Official title: Study of the Prevalence of Iron Deficiency in Patients With Chronic Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intestinal Disease
Lead sponsor: VIFORFRANCE
Sponsor class: INDUSTRY
First posted: 2019-10-11
Enrollment: 1100
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: Despite its known prevalence in IBD, a recent study conducted with Prof. Cacoub (unpublished) on the national health insurance database showed that iron deficiency was an under-diagnosed and under-treated co-morbidity. In chronic diseases including IBD, Transferrin Saturation Factor is only performed in approximately 10% of cases, whereas it is recommended in inflammatory situations including IBD patients (HAS 2011).

The objective of this study is therefore to obtain updated French data on the prevalence of iron deficiency in patients with IBD by applying the recommendations of ECCO and French Health High Authority (determination of ferritinemia and Transferrin Saturation Factor)


Eligibility criteria: Inclusion Criteria:

* Patient, male or female, over 18 years old
* Patient present at the hospital on the day of the study
* Diagnosis of IBD on international criteria
* Patient giving written consent

Exclusion Criteria:

* Protected patient: major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision;
* pregnant, lactating or parturient woman;
* Patient hospitalized without consent

Primary outcomes:
measure: Ferritinemia according to inflammatory status
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01546090: Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
Official title: Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inferior Alveolar Nerve Block Failure
Keywords: Alprazolam
benzodiazepines
Inferior alveolar nerve block
irreversible pulpitis
local anesthesia
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: University of Isfahan
First posted: 2012-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this prospective, randomized, double-blind, placebo-controlled study is to evaluate the effect of preoperative administration of alprazolam on the success of the IAN block for teeth with irreversible pulpitis.

Detailed description: Sixty patients diagnosed with irreversible pulpitis of a mandibular molar randomly receive, in a double-blind manner, identical capsules of either 0.50 mg alprazolam or placebo 45 minutes before the administration of a conventional IAN block. Access is begun 15 minutes after completion of the IAN block, and all patients profound lip numbness. Success is defined as no or mild pain based on visual analog scale recordings during access preparation and initial instrumentation.

Eligibility criteria: Inclusion Criteria:

* patients with active pain in a mandibular molar
* prolonged response to cold testing with Endo-Frost cold spray
* Absence of any periapical radiolucency on radiographs
* a vital pulp while access cavity preparation
* ability to understand the use of pain scales.

Exclusion Criteria:

* patients were having allergy and sensitivity to benzodiazepines
* pregnant and breast feeding patients
* patients who had taken sedation within 24 hours before the treatment
* having pain in more than one mandibular tooth
* unable to give informed consent

Primary outcomes:
measure: the success rate of the IAN block
timeFrame: one hour after administration of alprazolam
Secondary outcomes:
measure: initial pain
timeFrame: one hour after administration of alprazolam
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: School of Dentistry, Isfahan University of Medical Sciences
city: Isfahan
country: Iran, Islamic Republic of
facility: School of Dentistry, Isfahan University of Medical Sciences
Study officials:
References:
citation: Lindemann M, Reader A, Nusstein J, Drum M, Beck M. Effect of sublingual triazolam on the success of inferior alveolar nerve block in patients with irreversible pulpitis. J Endod. 2008 Oct;34(10):1167-70. doi: 10.1016/j.joen.2008.07.013. Epub 2008 Aug 23.
Clinical trial NCT05145790: The Place of Consultations Specializing in the Diagnosis of Mood Disorders in Strasbourg University Hospital
Official title: State of Play in Strasbourg University Hospital of the Place of Consultations Specializing in the Diagnosis of Mood Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mood Disorders
Keywords: Mood Disorders
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Major subject with pecialized primary consultation highlighting symptoms of mood disorders

Brief summary: Mood disorders (depressive disorders and bipolar disorders) are among the ten most worrying diseases of the 21st century according to the WHO.

In order to support psychiatrists in their diagnostic reflection, structures have been created. Since 2009, the Psychiatry Service 2 within the Psychiatry, Mental Health and Addictology Pole of the University Hospitals of Strasbourg has offered specialized consultations in mood disorders.

More than 10 years after the creation of these consultations, it seems interesting to study the profile of the users and to describe the nature of the reports of these in-depth evaluation consultations (diagnosis, therapeutic advice)


Eligibility criteria: Inclusion criteria:

* Major subject
* Specialized primary consultation highlighting symptoms of mood disorders with Prof. Berstchy in the psychiatry department 2 in the University Hospital of Strasbourg (patients whose consultation request was linked to symptoms or a diagnosis of ADHD will not be included in the study population).
* Consultation that took place in 2018 and 2019.
* Patient who did not express his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

* Patient opposition to the use of their personal data for scientific research purposes.
* Prior existence of a previous specialist consultation in mood disorders with Prof. Berstchy (the information collected during the first consultation is not accessible)
* Patient under curatorship, guardianship or legal protection

Primary outcomes:
measure: Descriptive study of the clinical characteristics of patients coming to consultations specializing in mood disorders in Strasbourg University Hospitals
timeFrame: Files analysed retrospectively from January 01, 2018 to December 31, 2019 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de psychiatrie 2 - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service de psychiatrie 2 - Hôpitaux Universitaires de Strasbourg
name: Gilles BERTSCHY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340090: Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
Official title: Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CHD - Coronary Heart Disease
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2017-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two randomized groups of 100 patients will undergo standard CABG procedure in Cardio-Pulmonary Bypass (CPB). In first group (100 patients) two pieces of Hemopatch will be applied in one patient. Second group is the control group without above described intervention.
Primary purpose: TREATMENT

Brief summary: The study aim is to assess polyethylene glycol (PEG) coated collagen patch (Hemopatch) on the quality of drainage after surgery, the length of hospital stay, the number of reoperations due to haemorrhage and treatment cost. The study will be conducted in 200 patients undergoing Coronary Artery Bypass Grafting (CABG) with the use of extracorporeal circulation and Internal mammary Artery (IMA) harvesting. Traditional method of haemostasis will be applied in 100 patients and Hemopatch will be additionally used in 100 subjects to prevent haemorrhage after IMA harvesting and sternum closure.


Eligibility criteria: Inclusion Criteria:

* coronary heart disease CHD (mammary harvesting)
* age\>18
* informed consent

Exclusion Criteria:

* any condition that exclude patient from standard CABG procedure
* additional cardiac procedure to be conducted on subject in addition to CABG

Primary outcomes:
measure: Total postoperative drainage (ml)
timeFrame: measured 48 hours after surgery
measure: need for blood transfusion (number of blood units transfused)
timeFrame: measeured after surgery until hospital discharge (on avarage until 7th day after surgery)
measure: The number of reoperations
timeFrame: observed until 7 days after surgery
Secondary outcomes:
measure: level of hemoglobin (g/dl)
timeFrame: after surgery until hospital discharge (on avarage until 7th day after surgery)
measure: length of Intensive Care Unit stay (h)
timeFrame: on average 48 hours after surgery
measure: hospital stay (days)
timeFrame: after surgery until hospital discharge (on average until 7th day after surgery)
measure: treatment cost (USD)
timeFrame: from patient hospital admission to hospital discharge ( on average 8-10 days)
Other outcomes:
Locations:
city: Łódź
country: Poland
facility: Medical University of Lodz
state: Lodzkie
Study officials:
affiliation: Medical University of Lodz
name: Michal Krejca, PhD, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04315090: Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Official title: Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Degenerative Spinal Arthritis
Cervical Myelopathy
Spinal Stenosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults scheduled to undergo posterior cervical spinal fusion.

Brief summary: This research study is being conducted to help improve the pre-operative, intra-operative, and post-operative course for patients and enhance recovery.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 89
* Diagnosis of cervical myelopathy, cervical stenosis, cervical disc disorder, or cervical spondylolisthesis

Exclusion Criteria:

* Cervical injury as the indication for surgery
* Emergent surgery

Primary outcomes:
measure: Length of stay
timeFrame: Will record length of stay in days 3 months following admission date.
Secondary outcomes:
measure: Rate of readmission
timeFrame: Within 3 months of discharge
measure: Numerical rating scale (NRS)- pain
timeFrame: immediately before, immediately after, and 3 months after surgery
measure: SF-12 short form
timeFrame: immediately before, immediately after, and 3 months after surgery
measure: Oswestry Disability Index
timeFrame: immediately before, immediately after, and 3 months after surgery
measure: Number of sessions with physical therapy and occupational therapy
timeFrame: will record number of physical and occupational therapy sessions during surgical admission 3 months following admission date
measure: Disposition status
timeFrame: will record discharge disposition 3 months following surgical admission date
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Matthew Neal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06601790: Evaluation of the Effectiveness, Safety, and Cost of a Smart Home-based Hospital System for Patients With Interstitial Lung Disease: Prospective Multicenter Randomized Controlled Trial
Official title: Evaluation of the Effectiveness, Safety, and Cost of a Smart Home-based Hospital System for Patients With Interstitial Lung Disease: Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to analyze the effectiveness/safety/cost of the Smart Homespital system that provides a service that allows patients with interstitial lung disease to easily access and use biosignals generated using biosignal collection medical equipment at home.


Eligibility criteria: Inclusion Criteria:

Patients diagnosed with COPD who meet the following pulmonary function test results:

1. Pre FEV1 \< 80% \*\*or\*\*
2. Pre FVC \< 80% \*\*or\*\*
3. DLCO \< 60%

Exclusion Criteria:

1. Patients who do not agree to participate in the study.
2. Patients who fail to use the medical device equipment.
3. Patients where tracking during the study period is expected to be impossible.
4. Patients who have difficulty communicating verbally.
5. Patients who are bedridden or unable to exercise at all due to severe cardiorespiratory dysfunction.
6. Patients receiving hospital-centered rehabilitation treatment during the study period.

Primary outcomes:
measure: Respiratory symptom questionnaire
timeFrame: After applying the Smart Homespital system(12weaks)
Secondary outcomes:
measure: Depression Questionnaire
timeFrame: Survey every 2 weeks during the 12-week Homespital system application, then at 3, 6, and 9 months after the start of the study.
measure: Service satisfaction evaluation
timeFrame: After 12 weeks of applying the Smart Homespital system.
measure: safety
timeFrame: Measured after the study ends (9 months later).
measure: cost assessment
timeFrame: After study ends (9 months later)
measure: 6 minute walking test
timeFrame: At 3, 6, and 9 months.
measure: pulmonary function test
timeFrame: At 3, 6, and 9 months.
measure: system compliance
timeFrame: During the 12-week period of applying the Homespital system.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Pulmonary and Critical Care Medicine
Study officials:
References: