louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05062590: Evolution and Adaptation to Caregiver of a Socio-geriatric Evaluation
Official title: Socio-geriatric Evaluation (ESOGER): A Clinical Tool in Telehealth to Fight Against Vulnerable Seniors's Health Alterations and Social Isolation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Isolation
Aging
Lead sponsor: Centre integre universitaire de sante et de services sociaux du Centre-Sud-de-l'Île-de-Montréal
Sponsor class: OTHER_GOV
First posted: 2021-09-30
Enrollment: 260
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: With the COVID-19 pandemic, elderly people (EP) living at home have seen their health deteriorated, thus increasing their needs in support and care. Indeed, while it was estimated that before the pandemic120 000 unattended living at home EP required care and services (taking bath, access to medication and food, etc.), the number doubled after COVID-19. Therefore, the waiting list for socio-medical services for unattended vulnerable clientele without a family doctor grew from 1300 à 1715 EP in a couple of months during the pandemic. With these numbers, it becomes clear that an intervention is needed. Truly, the Institut National d'Excellence en Santé et Services Sociaux (INESSS) conclude that it was pivotal to first identify the most vulnerable EP and second re-orient them according to their needs. Thus the investigator developed the Évaluation et orientation SOcio-GÉRiatrique (ESOGER) questionnaire available on a secure digital plateform enabling both a rapid evaluation and intervention to asses EP needs and provide the adequate ressources. Investigator's previous research has demonstrated that ESOGER is one of the rare clinical tools of first contact in telehealth while being global, multidimensional, and equitable. For this study, the investigator aims to evaluate the effect of ESOGER on EP physical and mental health, loss of autonomy, social isolation, quality of life and ressources consumption.


Eligibility criteria: Inclusion Criteria:

* Aged 65 and more
* Living at home on the territory CIUSSS-Centre-Sud de l'île-de-Montréal (CCSMTL) of Jeanne-Mance
* Brief Geriatric Assessment (BGA) score of 1/14 or more defining a severly to milidly frail health.

Exclusion Criteria:

* Principal address outside of the CCSMTL's Jeanne-Mance territory
* Participate at another clinical trial, to avoid interferences
* Not understand written or spoken French or English, questionnaires are only available in French and English.

Primary outcomes:
measure: COVID-19 symptoms
timeFrame: 3 months
measure: psychological fraility
timeFrame: 3 months
measure: Social health
timeFrame: 3 months
measure: Socio-economic characteristics
timeFrame: 3 months
measure: Participant's Quality of life
timeFrame: 3 months
measure: Autonomy
timeFrame: 3 months
Secondary outcomes:
measure: Caregiver burden
timeFrame: 3 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CRIUGM
state: Quebec
Study officials:
References:
Clinical trial NCT06648590: The Effect of Probiotics on the Improvement of Digestive Function and Well-being in the Elderly
Official title: Pediococcus Acidilactici on Digestive Function and Well-being in Older Adults: a Randomized, Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: People Aged 55-70 Years
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-18
Enrollment: 69
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of the use of probiotics as food supplements compared to placebo in improving digestive function and well-being in older adults.


Eligibility criteria: Inclusion Criteria:

* 1) Age is 55-70 years; 2) Willing to undergo 3 follow-up visits during the intervention period; 3) Willing to provide 2 blood, urine, and stool samples during the intervention period; 4) Willing to self-administer Pediococcus acidilactici PA53/placebo once daily during the intervention period; 5) Good eyesight, able to read and write, and can wear glasses; 6) Have good hearing and be able to hear and understand all instructions during the intervention.

Exclusion Criteria:

* 1) Suffering from digestive disorders, mainly gastrointestinal disorders (celiac disease, ulcerative colitis, Crohn's disease); 2) Has a severe neurological condition (epilepsy, stroke, severe head trauma, meningitis within the past 10 years, brain surgery, brain tumor, prolonged coma - excluding general anesthesia); 3) Has received/is receiving treatment for the following psychiatric disorders: alcohol/drug/substance abuse dependence, schizophrenia, psychosis, bipolar disorder; 4) Take medication for depression or low mood; 5) Suffering from internal organ failure (heart, liver, or kidney failure, etc.); 6) Radiotherapy or chemotherapy in the past; 7) Surgery/procedure under general anesthesia within the past three years, or planned to undergo a procedure/procedure under general anesthesia within the next 3 months during this trial; 8) Have had hepatitis (hepatitis B, hepatitis C), HIV or syphilis in the past; 9) Have taken Pediococcus acidilactici PA53 within the past 3 months.

Primary outcomes:
measure: Change in GSRS scale
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Xu fei
state: Henan
Study officials:
References:
Clinical trial NCT05617690: Cyclopol on Electrophysiological Monitoring During Spine Surgery: a Randomized Controlled, Noninferiority Study
Official title: Effect of Cyclopol on Intraoperative Electrophysiological Monitoring in Spine Surgery: A Randomized Controlled, Noninferiority Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Visual Evoked Potentials
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative visual function injury occurs after spinal cord, neurosurgery, ophthalmology and other operations, which directly affects the postoperative quality of life of patients. Flash visual evoked potential (FVEP) is important for evaluating visual function under general anesthesia during operation. The changes of visual function can be observed and recognized in time through the amplitude changes of FVEP, which can avoid or reduce the visual function damage during operation. Anesthesia method determines the success and variability of electrophysiological monitoring to a certain extent. The purpose of this study is to investigate the effect of total intravenous anesthesia based on cyclopol on FVEP compared with propofol.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing elective spinal surgery under general anesthesia;
2. Intraoperative electrophysiological monitoring is required;
3. 18-65 years old;
4. ASA I-III;
5. Sign the informed consent.

Exclusion Criteria:

1. Patients with visual impairment;
2. Patients with severe liver or kidney disease;
3. Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
4. Have mental illness or unable to communicate;
5. BMI≥30kg/㎡;
6. Abuse of analgesics and drug abuse history;
7. Muscle weakness, motor dysfunction or neuromuscular junction disease before operation;
8. Preoperative somatosensory dysfunction;
9. Retain trachea catheter after operation;
10. Narcotic drugs and silicone allergy;
11. Visual evoked potential monitoring was rejected.

Primary outcomes:
measure: N75-p100 amplitude of FVEP
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03640390: Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia
Official title: Dexmedetomidine Versus Magnesium Sulfate Infusion During Spinal Anesthesia for Lower Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this work is to compare the hemodynamic and analgesic properties of Dexmedetomidine and Magnesium sulphate infusion in lower abdominal surgery.

Detailed description: Dexmedetomidine is a relatively new alpha 2 adrenergic receptor agonist with a higher α2/α1 selectivity ratio of 1620:1 that provides analgesic and anesthetic effects . Dexmedetomidine has various clinical uses in anesthesia such as sedation, and prolongation of the duration of postoperative analgesia when used as an adjuvant through intrathecal, epidural, or intravenous routes.

Magnesium sulphate is another commonly used drug in anesthesia. Magnesium sulphate suppresses nociceptive impulses through inhibition of voltage-gated calcium channels and through antagonism of the N-methyl D-aspartate (NMDA) receptors.

Although both drugs were reported to prolong the duration of spinal anesthesia, no studies to the best of our knowledge had compared the analgesic and hemodynamic profile of both drugs when used as intravenously during spinal anesthesia.

Eligibility criteria: Inclusion Criteria:

* Adult patients aged between 18 and 65 years.
* Scheduled for lower abdominal surgery.

Exclusion Criteria:

* Systolic blood pressure less than 100 mmHg
* Coagulation disorders
* History of heart failure
* Mitral or Aortic stenosis

Primary outcomes:
measure: Duration of analgesia
timeFrame: 24 hours
Secondary outcomes:
measure: Systolic blood pressure
timeFrame: 6 hours
measure: Diastolic blood pressure
timeFrame: 6 hours
measure: Heart rate
timeFrame: 6 hours
measure: Onset of sensory block
timeFrame: 30 minutes after spinal anesthesia
measure: Onset of motor block
timeFrame: 30 minutes after spinal anesthesia
measure: Duration of motor block
timeFrame: 12 hours
measure: Ramsay Sedation Scale
timeFrame: 12 hours after spinal anesthesia
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Lecturer of anesthesia
name: Inas Farouk, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT00468390: Capsaicin-Evoked Pain in Patients With CRPS
Official title: Capsaicin-Evoked Pain in Patients With Complex Regional Pain Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CRPS (Complex Regional Pain Syndromes)
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
First posted: 2007-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: To evaluate the effect of capsaicin in patients with Complex Regional Pain Syndrome.

Detailed description: Primary outcome parameters: Capsaicin-induced pain and inflammation.

Secondary outcome parameters: Peripheral sensory and autonomic function.

Eligibility criteria: Inclusion Criteria:

* Age: 18 or older.
* Pain in arm or hand \> 3 months.
* Diagnosed with CRPS acc. to diagnostic research criteria (Harder et al., 2005)
* Inclusion of healthy subjects: age-, gender-, and BMI-matched.

Exclusion Criteria:

* Other significant disease affecting the parameters measured, including cardiovascular disease.
* Treatment with anticholinergics, sympathomimetics and parasympathomimetics, and alpha- and beta-adrenergics.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center, Aarhus University Hospital
name: Troels S Jensen, MD, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT06010290: The Novel 18F-labeled MAO-B PET Tracer Study in Parkinsonism Patients
Official title: The Novel 18F-labeled MAO-B PET/CT Imaging on Parkinsonism Patients of Chinese Population: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson Disease
Keywords: PET/CT
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-24
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population are recruited from the Department of Neurology of the First Affiliated Hospital of University of Science and Technology of China (USTC).

Brief summary: This study mainly aims to prospectively evaluate the changes of reactive astrogliosis in Parkinsonism patients of Chinese population by the novel 18F-labeled MAO-B PET tracer.

Detailed description: 18F-SMBT-1, the novel 18F-labeled MAO-B PET tracer, was evaluated reactive astrogliosis in Alzheimer's disease successfully. In this prospective study, we assess the changes of reactive astrocytes in cerebral gray matter and white matter on Parkinson's disease by 18F-SMBT-1 PET/CT imaging among Chinese population.

Eligibility criteria: Inclusion Criteria:

* Aged from 40 to 90 years old.
* Clinically diagnosed as Parkinsonism, including Parkinson's disease and atypical Parkinsonism syndromes.
* Can cooperate with 18F-FDG PET/CT, 18F-FP-CIT PET/CT and 3D T1-weighted structural MR scans.
* Complete clinical data, including modified Hoehn and Yahr staging scale and the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

Exclusion Criteria:

* Cannot cooperate with PET/CT or MR examination.
* Associated with brain diseases such as stroke, brain trauma, brain tumor, and cranial surgery.

Primary outcomes:
measure: Standard uptake value ratio (SUVR)
timeFrame: 60 days
measure: Clinical parameters
timeFrame: 60 days
Secondary outcomes:
measure: Correlation coefficient 1
timeFrame: 60 days
measure: Correlation coefficient 2
timeFrame: 60 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of China University of Science and Technology
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of China University of Science and Technology
name: Qiang Xie, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05059990: Low Intensity Aerobic Exercise and Active Exercises in Cancer Patients Receiving Palliative Care
Official title: Comparison of Low Intensity Aerobic Exercise and Active Exercises on Cancer Related Fatigue in Cancer Patients Receiving Palliative Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Low intensity Aerobic Exercise
ROM Exercise
Palliative Care
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To compare the effect of low intensity aerobic exercise and active ROM exercises on cancer related fatigue and its associated symptoms and quality of life in cancer patients receiving palliative care.


Eligibility criteria: Inclusion Criteria:

* ability to give written consent.
* Diagnosed advance cancer specifically gastrointestinal tract (GIT) cancer, Lung cancer and Breast cancer etc. (stage 2 and 3).
* Intensity of fatigue ≥4 out of 10 on fatigue Numerical Rating Scale in first visit observation
* Survival expectancy more than one month,
* Functional status allowing the participants to participate in the proposed therapy.

Exclusion Criteria:

* Anemia (Hb ≤ 8g/dl),
* Existence of other comorbidities causing fatigue (i.e. Parkinson's, Multiple sclerosis, Heart failure),
* Infection requiring antibodies
* bone metastases,
* thrombocytopenia (\<50×109/l),
* myocardial infarction within the past three months
* uncontrolled hypertension (diastolic pressure \>95 mm Hg).

Primary outcomes:
measure: Fatigue Numeric Rating Scale
timeFrame: 4th Week
measure: Karnofsky Performance Status
timeFrame: 4 Week
measure: Edmonton Symptom Assessment Scale (ESAS)
timeFrame: 4 week
measure: Brief Fatigue Inventory (BFI):
timeFrame: 4 week
Secondary outcomes:
measure: Quality of life questionnaire for cancer patients treated with anti-cancer drugs (QOL-ACD):
timeFrame: 4 week
Other outcomes:
Locations:
city: Sargodha
country: Pakistan
facility: Mubarak Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University
name: Abeer Fatima, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04854590: IMFINZI Study in Patients With Extensive Stage Small Cell Lung Cancer
Official title: IMFINZI® Injection 120 mg, 500 mg Specific-Clinical Experience Investigation in Patients With Extensive Stage Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Small Cell
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-04-22
Enrollment: 248
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with extensive stage small cell lung cancer

Brief summary: To capture safety(FN) when IMF is administered to patients with extensive stage small cell lung cancer in clinical practice after launch

Detailed description: To capture the onset (incidence, severity, intervention, outcome, and others) of febrile neutropenia in patients with extensive stage small cell lung cancer who receive durvalumab in combination with platinum agent and etoposide under the actual use.

Eligibility criteria: Inclusion Criteria:

-Patients with extensive stage small cell lung cancer who are receiving the product in combination with platinum agent and etoposide.

Exclusion Criteria:

-Patients who have no treatment history with the product (i.e.,durvalumab)

Primary outcomes:
measure: Incidence of febrile neutropenia (yes/no) and by severity (CTCAE grade)
timeFrame: 16weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tottori
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
Study officials:
affiliation: Astrazeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References:
Clinical trial NCT05689190: Non-invasive Flow Measurements in Patients with Lower Extremity Arterial Disease (LEAD)
Official title: Non-invasive Flow Measurements in Patients with Lower Extremity Arterial Disease (LEAD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lower Extremity Arterial Disease
Keywords: blood flow measurements
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
Collaborators: name: Leiden University Medical Center
First posted: 2023-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30 patients that are referred to the Vascular Surgery outpatient clinic (department of Vascular Surgery) with PAD and an indication for a percutaneous transluminal angioplasty.

Brief summary: This concerns a study with patients who will undergo endovascular treatment. Blood flow will be measured by 2D Duplex Ultrasound. Contrast data will be collected that will be processed offline.


Eligibility criteria: Inclusion Criteria:

* Patients referred to the vascular surgery outpatient clinic (LUMC) with PAD
* Age ≥18 years
* Superficial femoral artery (SFA) stenosis (\>70% occluded)
* Elective for a percutaneous transluminal angioplasty procedure
* Written informed consent

Exclusion Criteria:

* Contraindications to angiography, such as severe renal insufficiency (eGFR\< 20)
* Non-correctable bleeding disorder.

Primary outcomes:
measure: blood flow
timeFrame: performed during a regular PTA intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Carla SP van Rijswijk
role: PRINCIPAL_INVESTIGATOR
References: