louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05129150: Cognitive Disorders and Brain Pulse
Official title: Cognitive Disorders and Brain Pulse
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurocognitive Disorders
Keywords: Brain pulse
ultrasound
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions

Brief summary: Following an initial consultation with a memory, resources and research centre (MRRC) doctor, a day hospital may be prescribed to carry out an assessment of cognitive disorders. Patients are then usually followed up in consultation at least once a year, in the framework of a new day hospital and/or consultations with a MRRC doctor.

Detailed description: Patients will be included at the time of the day hospital assessment. All patients received in the day hospital of the MRRC of Tours will be offered the TPI examination. The patients included will be followed up for a period of 5 years and the TPI examination will be repeated according to the same modalities, as part of their follow-up at the MRRC and/or in the context of a new day hospital if necessary.

Eligibility criteria: Inclusion Criteria:

* Patient benefiting from a day hospital at the MRRC of the CHU of Tours for assessment of cognitive functions

Exclusion Criteria:

* Refusal of TPI ultrasound examination
* Patients who opposed to data processing
* Patients under judicial protection

Primary outcomes:
measure: maximum amplitude of brain movements
timeFrame: one a year from inclusion visit to 5 years
measure: mean of brain movements
timeFrame: one a year from inclusion visit to 5 years
measure: standard deviation of brain movements
timeFrame: one a year from inclusion visit to 5 years
measure: powers in frequency analysis
timeFrame: one a year from inclusion visit to 5 years
Secondary outcomes:
measure: Brain pulse
timeFrame: one a year from inclusion visit to 5 years
measure: Brain pulse
timeFrame: one a year from inclusion visit to 5 years
measure: Hippocampal volume
timeFrame: one a year from inclusion visit to 5 years
measure: leucoaraiosis load
timeFrame: one a year from inclusion visit to 5 years
measure: Carbohydrate metabolism
timeFrame: one a year from inclusion visit to 5 years
measure: Spinal fluid biomarkers
timeFrame: one a year from inclusion visit to 5 years
measure: cohort study on brain pulsatility with neuropsychological measures
timeFrame: one a year from inclusion visit to 5 years
Other outcomes:
Locations:
city: Tours
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Tours
name: Thomas DESMIDT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01628250: Laparoscopic Complete Mesocolic Excision on Colon Cancer
Official title: Clinical Research on the Efficacy and Feasibility of Laparoscopic Complete Mesocolic Excision on Colon Cancer: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Operation Finding
Complications
Pathology
Quality of Life
Neoplasms Recurrence
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery technique to perform a resection for colon cancer. Besides, the segment of the colon containing the tumor, the resection area should include an intact mesocolon as an envelope to encase the possible route for metastasis. The routes include blood vessels, lymphatic drain and etc. Such hypothesis predicts better histopathological and higher oncological results which turns into better survival rate and better quality of life.


Eligibility criteria: Inclusion Criteria:

* Patients with pathologically confirmed colon cancer
* Signed consent

Exclusion Criteria:

* History of malignancy
* Intestinal obstruction or perforation
* Evidence of metastasis by preoperative examinations
* Deformity of spine
* Emergency case
* BMI \> 29

Primary outcomes:
measure: Histopathological Outcomes Obtained Through the Surgeries
timeFrame: 14 days after the surgery
Secondary outcomes:
measure: Survival Rate
timeFrame: 3 years after the surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital affiliated to Shanghai Jiaotong University school of medicine
state: Shanghai
Study officials:
affiliation: Shanghai Minimally Invasive Surgery Center
name: Bo Feng, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06927050: Visual Communication: Digital Tool to Improve the Understanding of Treatment Options for Patients With Cancer and Increase Satisfaction of the Overall Experience for Patients, Caregivers, and Providers
Official title: Visual Communication: Can a Digital Tool Improve the Understanding of Treatment Options for Patients With Cancer and Increase Satisfaction of the Overall Experience for Patients, Caregivers, and Providers?
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a study in patients with newly diagnosed cancer to prospectively evaluate the feasibility of integration of a visual communication tool for patients/caregivers/providers by determining whether such a tool can increase overall satisfaction with the patient experience.


Eligibility criteria: Inclusion Criteria:

Patients:

* Patients seen in consultation from 12/1/2024-6/1/2025
* Patients aged 18 years to 100 years old
* Patients with a malignancy of breast or head and neck
* English speaking patients
* Patients being treated with definitive intent
* Patients treated at NYU Langone Health for their malignancy
* Willing and able to provide consent

Caregivers:

* Any adult caregiver(s) (aged 18 years to 100 years old) to a patient who fulfills the inclusion and exclusion criteria above.
* Willing and able to provide consent

Providers:

* Doctors and nurse practitioners in medical oncology and radiation oncology, and in the ear nose throat (ENT) department.
* Willing and able to provide consent
* aged 18 years to 100 years old

Exclusion Criteria:

Patients:

* Patients with any other site of disease other than listed above
* Non-English-speaking patients, as the tool is currently available in English only. Translation into additional languages such as Spanish and Russian is currently in process.
* Patient unable to complete the survey portion of the study independently

Caregivers:

• Unable to complete the survey portion of the study independently

Primary outcomes:
measure: Percentage of "Satisfied" Patients
timeFrame: Day 0
Secondary outcomes:
measure: Percentage of "Satisfied" Caregivers
timeFrame: Day 0
measure: Percentage of "Satisfied" Providers
timeFrame: Day 0
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jason Domogauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05541250: Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Official title: Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Peripheral Nerve Injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2022-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.


Eligibility criteria: Inclusion Criteria:

1. Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
2. Between the ages of 18 and 65 at last birthday

Exclusion Criteria:

1. Persons unable to safely undergo an MRI;
2. Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
3. Persons with severe peripheral nerve injury gap length \> 10 cm;
4. Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
5. Pregnant women or a positive pregnancy test in those women with reproductive potential prior to enrollment;
6. Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
7. History of active substance abuse;
8. Persons allergic to gentamicin;
9. Persons who test positive for HIV or Hepatitis B or C virus.
10. Persons unable to provide consent independently due to cognitive impairment

Primary outcomes:
measure: Incidence of Treatment-related Adverse Events (AEs)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Motor Recovery as assessed using the MRC Grading Scale
timeFrame: Up to 2 years
measure: Sensory recovery as assessed by Pin-Prick Evaluation
timeFrame: Up to 2 years
measure: Sensory recovery as assessed by the 2-Point Discrimination Evaluation
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: W. Dalton Dietrich, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05602350: Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys
Official title: Testing Response Bias on Sensitive Topics in Self- Versus Enumerator-administered Surveys
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bias, Implicit
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
First posted: 2022-11-02
Enrollment: 7500
Sex: MALE
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Within a survey of adolescent males in Medellin schools (mainly 13-year old boys) the researchers are randomizing whether survey respondents answer sensitive questions themselves or are asked the questions by an enumerator. Questions are of three main varieties: (1) antisocial behaviors, (2) symptoms of depression, and (3) symptoms of anxiety.


Eligibility criteria: Inclusion Criteria:

* All male students in seventh grade in a sample of public schools are eligible. The sample corresponds to a representative sample of public schools (we aim at 90 schools)

Exclusion Criteria:

* Female students or students not in seventh grade

Primary outcomes:
measure: The main outcome is the mean difference in survey responses for an average of the three indexes being measured
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Innovations for Poverty Action
state: Antioquia
Study officials:
References:
Clinical trial NCT03324750: Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients
Official title: Long-term Corticosteroid Use and Lifestyle Advices: A Qualitative Analysis of the Difficulties Encountered by Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Traited by Long Term Corticotherapy
Keywords: corticotherapy
qualitative study
therapeutic education
lifestyle change
diet
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by long-term corticotherapy

Brief summary: Introduction: Nearly 1% of the population is currently treated with long-term corticosteroid therapy. When corticosteroids are introduced, patient information concerning the adverse effects and the modalities of prevention by the lifestyle changes is usually proposed. However, studies have shown an imperfect acquisition of this information about treatment and prevention of adverse effects, as well as a difficult implementation on diet and physical activity advices. In this study, the investigators aimed to evaluate the difficulties encountered by patients with dietary advice in the context of long-term corticosteroids use in order to optimize care, drug adherence and the quality of life of patients.

Methods: the investigators will recruite adult patients from general medicine and rheumatology practice and treated by long-term corticosteroids (≥ 3 months, ≥ 5mg/day). the investigators will perform a qualitative analysis in a semi-directed interview.

Detailed description: Prospective Qualitative Study Carried out among patients followed in rheumatology and in general medical practice.

For each voluntary patient, a semi-directed interview was carried out in a consultation room after obtaining his agreement.

The same investigator used a single guide and conducted all the interviews based on open-ended questions.

At the end of the interviews, the entire recorded audio data was converted in written form before being analysed thematically.

Data were analysed using a Fisher's exact test for categorical variables (presented as frequencies and percentages), and using a non-parametric Mann-Whitney test for continuous variables (presented as the median and interquartile range, IQR).

Eligibility criteria: Inclusion Criteria:

* adult patients taking corticosteroids at an average dose ≥ 5 mg/day of equivalent prednisone over a period ≥ 3 months.

Exclusion Criteria:

* major memory impairment or language barrier.

Primary outcomes:
measure: the difficulties encountered by patient in relation to the health and dietary advice given by physicians in the context of long term corticodteroid use
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Lapeyronie
Study officials:
References:
Clinical trial NCT00584350: Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
Official title: Prevention of Contrast Nephropathy During Diagnostic Coronary Angiogram or PCI With Hydratation Based on LEVDP
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Radiographic Contrast Agent Nephropathy
Renal Failure
Coronary Heart Disease
Keywords: coronary angiogram
percutaneous coronary intervention
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2008-01-02
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.

Detailed description: The goal is to determine if prehydration based on LEVDP is superior to a standard hydratation, independant of volemic status, with NaCl 0.9% or NaHCO3 for the prevention of contrast nephropathy related to a diagnostic coronary angiogram or to PCI.

Eligibility criteria: Inclusion Criteria:

* minimum 18 years old
* chronic renal insufficiency with a calculated creatinine clearance below 60 cc /min. (estimated with the MDRD formula)
* hemodynamically stable

Exclusion Criteria:

* Acute renal failure or in recuperation of acute renal failure
* urgent coronary angiogram
* moderate to severe valvulopathy or presence of a valvular prosthesis
* diagnostic of multiple myeloma
* dialysis before test
* having had a test with contrast product in the 2 weeks preceding
* receiving a nephrotoxic in the last month.

Primary outcomes:
measure: Incidence of contrast nephropathy described as an increase of 44 micromol/L in plasma creatinine 48 hours after the injection of contrast product.
timeFrame: 48 hours
Secondary outcomes:
measure: changes in glomerular filtration in the 3 groups (measured with MDRD formula)
timeFrame: 48 hours
measure: clinical events during the procedure or after (ex. pulmonary edema)
timeFrame: during hospitalisation
measure: Incidence of contrast nephropathy defined as an increase of 25% of the creatinine value at 48 hours
timeFrame: 48 hours
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: CHUS, clinical research center
state: Quebec
Study officials:
affiliation: Sherbrooke University
name: Michel Nguyen, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04550650: Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
Official title: Follow-up Study of the Effectiveness of Virtual Reality Therapy in MS Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis, Primary Progressive
Keywords: multiple sclerosis
posture
neurorehabilitation
balance
Lead sponsor: Somogy Megyei Kaposi Mór Teaching Hospital
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 4
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different therapies can improve clinical and motor symptoms of multiple sclerosis (MS) similarly, but studies comparing the effects of different exercise therapies on clinical and motor outcomes are scant. We compared the effects of exergaming (EXE), balance (BAL), cycling (CYC), proprioceptive neuromuscular facilitation (PNF), and a standard care wait-listed control group (CON) on clinical and motor symptoms and quality of life (QoL) in people with MS (PwMS).

Methods: PwMS (n = 68, 90% female; age, 47.0 yr; Expanded Disability Status Scale score 5-6) were randomized into five groups. Before and after the interventions (five times a week for 5 wk), PwMS were tested for MS-related clinical and motor symptoms (Multiple Sclerosis Impact Scale-29 (MSIS-29), primary outcome), QoL (EuroQol Five Dimensions Questionnaire), symptoms of depression, gait and balance ability (Tinetti Assessment Tool), static and dynamic balance and fall risk (Berg Balance Scale), walking capacity (6-min walk test), and standing posturography on a force platform.

Patients were followed up for 2 years after 5 weeks of intensive care. Tests are performed every six months.


Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis
* instability problem

Exclusion Criteria:

• Severe heart problems, severe demeanor, alcoholism, drug problems

Primary outcomes:
measure: Postural instability
timeFrame: 2 years
measure: EQ-5D quality of life
timeFrame: 2 years
measure: balance test
timeFrame: 2 years
measure: mobility test
timeFrame: 2 years
measure: depression scale
timeFrame: 2 years
measure: MSIS-29
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
state: Somogy
Study officials:
References:
Clinical trial NCT00533650: Proof of Concept (Bone Resorption/Bone Mineral Density) Study (0429-005)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Post-Menopausal Osteoporosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 227
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to asses the safety and efficacy of MK0429 in postmenopausal women with osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Person is a women with osteoporosis who is unwilling or unable to take other treatments for osteoporosis

Exclusion Criteria:

* Person has had a previous fracture
* Person has rheumatoid arthritis. Person has has certain types of cancer
* Person has donated blood or has been in another investigational study within the last 4 weeks

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04957550: To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Psoriatic Arthritis Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-07-12
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: SHR0302 tablets compared with placebo
Primary purpose: TREATMENT

Brief summary: This study is a phase 3 study,to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active psoriatic arthritis.


Eligibility criteria: Inclusion Criteria:

1. Provide signed informed consent；
2. Diagnosis of PsA fulfillment of the Classification Criteria for PsA (CASPAR) criteria with symptom onset at least 6 months prior to the Screening Visit；
3. Active arthritis at screening/baseline as indicated by \>/= 3 tender/painful and 3 swollen joints；
4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.

Exclusion Criteria:

1. History of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases；
2. Non-plaque forms of psoriasis (with exception of nail psoriasis)；
3. Previous treatment with cytotoxic drugs; JAK inhibitor or bDMARDs within 6 months of randomization.

Primary outcomes:
measure: ACR20 response rate at week 24
timeFrame: Week 24
Secondary outcomes:
measure: ACR20 response rate at week 48
timeFrame: Week 48
measure: ACR50/70 response rate at week 24 and week 48
timeFrame: Week 24 and week48
measure: Change from baseline in DAS28-CRP week 24 and week 48
timeFrame: Week 24 and week 48
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Hospital
state: Beijing
Study officials:
References: