louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06646601: A Preventive, Multidisciplinary Primary Care Intervention Organized Around a Therapeutic Garden: Acceptability to Patients Suffering from Cardio-neurovascular Pathology and to Those Involved in the Action.
Official title: A Preventive, Multidisciplinary Primary Care Intervention Organized Around a Therapeutic Garden: Acceptability to Patients Suffering from Cardio-neurovascular Pathology and to Those Involved in the Action.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Vascular Disease
Cardiovascular
Atrial Fibrillation (AF)
Heart Failure NYHA Class II
Cardiomyopathies
Stroke, Ischemic
Hypertension Resistant to Conventional Therapy
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: A preventive, multidisciplinary primary care intervention organized around a therapeutic garden: Acceptability to patients suffering from cardio-neurovascular pathology and to those involved in the action.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years old;
* living in the vicinity (+-20 km) of Gap, Laragne-Montéglin, Veynes and Clermont-Ferrand;
* having been invited to take part in the intervention by the caregivers of the medical structures
* suffering from an ALD based on CNAM medical criteria (stroke, AOMI, rhythm disorders, valvular heart disease, congenital heart disease, stage I and II heart failure), severe hypertension, chronic coronary disease)

Exclusion Criteria:

* heart failure based on CNAM medical criteria (ALD n°5) stage III and IV according to NYHA classification ;
* with a contraindication to physical activity ;
* living in an institution;
* unable to walk more than 100 m independently;
* Alzheimer's disease or other dementias based on CNAM medical criteria ;
* with an unlabelled cognitive impairment limiting comprehension.

Primary outcomes:
measure: Acceptance rate of intervention
timeFrame: From enrollment to the end of treatment at 6 months
measure: Identification of the obstacles and facilitators for intervention
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Assessing the impact of the intervention
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Gap
country: France
facility: Gap +/- 20 km
Study officials:
References:
Clinical trial NCT01776801: Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human
Official title: Assessment of Autonomic Neuronal Changes During Moderate Rise of Intracranial Pressure in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Increased Intracranial Pressure Disorders
Keywords: intracranial baroreflex
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this project is to determine during moderate rise of intracranial pressure (ICP) in awake patient, the change in autonomic function and its influence on cerebral and systemic haemodynamics.

Detailed description: From preliminary data, we know that changes in ICP influences both systemic and cerebral haemodynamics, introducing the concept of intracranial baroreflex We have to i) confirm the presence of this intracranial baroreflex, ii) analyze the changes in autonomic function during moderate rise in intracranial pressure (ICP) in human, and iii) correlate the changes in cerebral and systemic haemodynamics with autonomic function.

Eligibility criteria: Inclusion Criteria:

* patient suspect of hydrocephalus with gait problems, urine incontinence and mild cognitive impairment.
* signed consent

Exclusion Criteria:

* psychiatric problems
* severe cognitive decline

Primary outcomes:
measure: change in sympathetic nerve activity after rise in ICP
timeFrame: within few minutes
Secondary outcomes:
measure: change in hemodynamics after rise in ICP
timeFrame: within few minutes
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
city: Toulouse
country: France
facility: University Hospital Toulouse
city: Toulouse
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Eric SCHMIDT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03604601: Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma
Official title: Analysis of the Curative Effect of Salvage Surgery on Recurrent Laryngeal Carcinoma: A Single-institutional Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Laryngeal Carcinoma
Keywords: salvage surgery
recurrent laryngeal carcinoma
experience
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with recurrent laryngeal squamous cell carcinoma

Brief summary: Early laryngeal cancer can be treatment by laser surgery or radiotherapy, intermediate and advanced laryngeal carcinoma mainly surgical treatment. Laryngeal cancer is at risk of recurrence after treatment, whether in surgery, laser or radiotherapy. The recurrence rate of laryngeal cancer is about 10% reported at home and abroad. Local pain, ulcers, breathing and eating difficulties caused by recurrent laryngeal cancer seriously reduce the quality of life of patients and seriously endanger their lives. Therefore, head and neck surgeons are required to make every effort to give them saving treatment in order to improve their quality of life. Prolong the patient's life.

Detailed description: medical records and extracted information including age, gender, initial treatment modality of glottis cancer, recurrence time, recurrence site, histopathology, tumor grade according to World Health Organization (WHO) grade and tumor stage. Stages were defined according to the American Joint Committee on Cancer (AJCC) staging system.

Eligibility criteria: Inclusion Criteria:

* more than 18 years,
* patients with recurrent glottic laryngeal squamous cell carcinoma undergoing salvage surgery

Exclusion Criteria:

* postoperative radiotherapy and chemotherapy
* loss to follow-up

Primary outcomes:
measure: overall survival (OS)
timeFrame: Follow up 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Genglong Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06776601: Digital Therapy in Self-management of COPD Patients
Official title: Digital Therapy in Self-management of Chronic Obstructive Pulmonary Disease Patients：A Prospective, Open-labled, Multicenter Randomized Controlled Clinical Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
adherence
inhaled medication
self management
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 600
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project adopts a whole-process digital therapy intervention package composed of an inhalation technique assessment device, an electronic inhalant medication monitoring device and digital software to guide patients use the inhaler correctly personalizedly, record and manage the behavior data of chronic obstructive pulmonary disease (COPD) patients during the use of inhalant medication, and provide personalized reminders and feedback to patients according to the data. The purpose is to analyze whether this digital intervention scheme can reduce the number of acute exacerbations of COPD, improve the management effect of COPD, and reduce the burden of disease by improving the medication compliance of COPD patients.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed with COPD
2. Aged 40 and above
3. Had one or more severe acute exacerbations in the past year, and be in stable condition for the last 4 weeks
4. Can operate a smartphone proficiently
5. Take inhalation medication suits for the inhalation monitoring device as treatment
6. Fully understand and be willing to sign the informed consent form

Exclusion Criteria:

1. Certain comorbidities (e.g. unstable coronary complications)
2. Undergone thoracic, abdominal or ophthalmic surgery in recent 3 months
3. Pregnant or lactating women
4. ABS allergy history

Primary outcomes:
measure: severe exacerbation
timeFrame: 12 month
Secondary outcomes:
measure: First Second Forced Expiratory Volume/ Forced Vital Capacity
timeFrame: 12 month
measure: First Second Forced Expiratory Volume percentage of estimated
timeFrame: 12 month
measure: peak expiratory flow
timeFrame: 12 month
measure: COPD Assessment Test score
timeFrame: 12 month
measure: modified Medical Research Council scale
timeFrame: 12 month
measure: St. George's Respiratory Questionnairefor chronic obstructive pulmonary disease (SGRQ) score
timeFrame: 12 month
measure: peak inspiratory flow rate
timeFrame: 12 month
measure: mild and moderate exacerbation
timeFrame: 12 month
Other outcomes:
Locations:
city: Beijing
country: China
facility: China Japan Friendship Hospital
state: Beijing
Study officials:
affiliation: China Japan Friendshi Hospital
name: Hongtao Niu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06744101: Comparative Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions
Official title: Comparative Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast LN
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Evaluation of Diffusion Weighted MRI And Ultrasonography In The Detection of Breast Lesions

Brief summary: This study aims to conduct a comparative evaluation of Diffusion Weighted MRI (DW-MRI) and Ultrasonography (US) in detecting breast lesions. Breast cancer remains a leading cause of cancer-related deaths among women worldwide, necessitating efficient and accurate diagnostic methods. Ultrasonography, a commonly used imaging modality, provides valuable insights into breast lesions but has limitations in sensitivity and specificity.

Detailed description: Diffusion Weighted MRI, on the other hand, shows potential for higher accuracy in identifying malignant versus benign lesions due to its ability to assess tissue cellularity and integrity non-invasively. This research will involve a specified number of female participants within a defined age range, focusing on the comparative effectiveness, sensitivity, and specificity of DW-MRI and US. The findings are expected to contribute valuable insights into optimizing breast cancer diagnostic protocols, ultimately aiding in earlier detection, better patient outcomes, and possibly reducing the need for invasive biopsy procedures.

Eligibility criteria: Inclusion Criteria:

* Women with suspected breast lesions
* Breast feeding woman
* Referred for MRI examination.
* Age 18 years or older
* Ability to provide informed consent.

Exclusion Criteria:

* Contraindications to MRI or contrast agent
* Previous breast Implant
* Early Pregnancy

Exclusion criteria

\*

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: 563-B peoples colony 1 main satiana road Faisalabad
state: Punjab
Study officials:
References:
Clinical trial NCT02174601: A Pre-endoscopic Prediction Model for Inadequate Bowel Preparation in Patients Receiving Split Dose Polyethylene Glycol Preparation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colonoscopy
Keywords: bowel preparation
coolprep
colonoscopy
prediction model
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-25
Enrollment: 500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy subjects, more than 20 years old, who admitted to the health promotion center for performing colonoscopy.

Brief summary: After written consent for participating in clinical research studies, all clinical studies conducted to in the one day. The investigators will ask and record about bowel cleansing state in all patients who performed colonoscopy. There is no additional cost and the expected complications.

Based on answer, the investigators will develop a prediction model for inadequate bowel preparation and prove validation. This model can take the additional measures to subjects predicting improper cleansing. It can contribute to improve the accuracy of the test and reduce the discomfort due to re-performing colonoscopy after re-preparation, as well as cost savings due to reduced frequency of re-colonoscopy Ultimately, it will be able to bring a improvement of the quality of management


Eligibility criteria: Inclusion Criteria:

* Adults over 20 years old

Exclusion Criteria:

* Less than 20 years old
* Cardiac, renal, and metabolic dysfunction in patients with serious adverse
* Mental or central nervous system disorders
* Individuals with bwel obstruction
* Individuals who can not read and understand the consent form (literacy, foreign, etc.) However, although individuals with vision / hearing disturbance and deterioration of cognitive abilities, they may participate in the research if can be able to complete the survey with one guardian or the help of researchers.

Primary outcomes:
measure: bowel cleansing state
timeFrame: average 24hours before colonoscopy after taking coolprep
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance hospital
Study officials:
References:
Clinical trial NCT05034601: ESPB vs TPVB for Postoperative Analgesia After the Nuss Procedure
Official title: Comparison of Erector Spinae Plane and Paravertebral Nerve Blocks for Postoperative Analgesia in Children After the Nuss Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Analgesia
Pectus Excavatum
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2021-09-05
Enrollment: 68
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a prospective randomized double-blind non-inferiority trial designed to test the hypothesis that erector spinae plane block (ESPB) is non-inferior to thoracic paravertebral block (TPVB) in postoperative pain control after pectus excavatum repair.


Eligibility criteria: Inclusion Criteria:

* Age between 4 to 18 years Scheduled for elective Nuss surgery Written informed consent is obtained from parents of each patient.

Exclusion Criteria:

* Coagulation dysfunction. American Society of Anesthesiologists Physical Status 4 or 5. Allergy to study medication. Local infection at the site of injection or systemic infection. Inability to understand Chinese.

Primary outcomes:
measure: Pain scores at rest at 24 hours postoperatively
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: The pain degree at rest and after movement or coughing(dynamic)
timeFrame: at 3, 6, 12, 24, and 48 hours after surgery
measure: total rescue morphine-equivalent consumption per weight
timeFrame: at 24 and 48 hours after surgery
measure: Emergence agitation at 5, 15, 30 min after extubation
timeFrame: at 5, 15, 30 min after extubation
measure: Total dosage of intraoperative sufentanil and remifentanil
timeFrame: during surgery
measure: The time to first analgesia request
timeFrame: within the 3 days after surgery
measure: The time to first mobilization
timeFrame: within the 3 days after surgery
measure: Side effects
timeFrame: within the 5 days after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Department of Anesthesiology, West China Hospital
state: Sichuan
Study officials:
affiliation: Department of Anesthesiology, West China Hospital, Sichuan University
name: Jin Liu
role: STUDY_CHAIR
References:
citation: Xu M, Zhang G, Gong J, Yang J. Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial. Trials. 2022 Feb 14;23(1):139. doi: 10.1186/s13063-022-06044-y.
Clinical trial NCT06966401: Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Official title: A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Depression
Major Depressive Disorder
NBI-1065845
TAK-653
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2025-05-11
Enrollment: 600
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 will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.


Eligibility criteria: Key Inclusion Criteria:

* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
* Participant must have been taking oral antidepressants for at least 8 weeks prior to screening.
* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Key Exclusion Criteria:

* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.

Other protocol defined inclusion and exclusion criteria apply.

Primary outcomes:
measure: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Baseline through Week 52
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT03527901: Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease
Official title: Evaluation of Active Matrix Metalloproteinase-8 (aMMP-8) Chair-side Test in Different Periodontal Disease and Healthy Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Keywords: aggressive periodontitis
healthy peri-implant
chairside test
chronic periodontitis
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 103
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants have minimum 20 teeth

Brief summary: The aim of this study to evaluate the diagnostic accuracy of a new qualitative aMMP-8 POC test in different periodontal health and disease and as compared to the established quantitative laboratory method (ELISA)

Detailed description: MMP-8 has been reported to reflect the inflammatory status in periodontal tissues and, therefore represent as potential biomarkers of periodontitis. A positive aMMP-8 test could be an early indicator of these excessive and undesired tissue reactions.

Eligibility criteria: Inclusion Criteria:

* Systemically healthy
* Nonsmokers

Exclusion Criteria:

* Participants were not included if they had systemic disease such as diabetes, cardiovascular.
* Participants who took regular medications that could affect of periodontal tissue
* Participants who received antibiotics less than 10 weeks before the study

Primary outcomes:
measure: aMMP-8 levels of GCF
timeFrame: 2 hours
Secondary outcomes:
measure: Salivary MMP-8 levels
timeFrame: 2 hours
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00982267: A Trial Of SU14813 In Patients With Advanced Solid Malignancies
Official title: A Phase I Dose Escalating Study Of SU014813 In Patients With Solid Tumors Not Amenable To Conventional Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Solid Tumors
Keywords: cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-23
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to define the Maximum tolerated dose of SU14813 when administered as single agent in patients with solid tumors.


Eligibility criteria: Inclusion Criteria:

* Patients with a histologically proven advanced solid malignancy for which no recognized therapy was available or for which standard therapy had failed
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Serum albumin ≥3.0 g/dL and adequate haemopoietic, renal and liver function

Exclusion Criteria:

* Chemotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) or radiotherapy or an investigational agent within 4 weeks before the start of study treatment
* Subjects had to have recovered from all prior treatment toxicities, except alopecia, and from any major surgery.

Primary outcomes:
measure: Maximum Tolerated Dose (MTD)
timeFrame: 18-Nov-2008
Secondary outcomes:
measure: Determine the recommended Phase 2 dose (RP2D)
timeFrame: 18-Nov-2008
measure: Preliminary information on SU014813 anti-tumor effect;
timeFrame: 18-Nov-2008
measure: Plasma pharmacokinetics
timeFrame: 18-Nov-2008
measure: Plasma targets such as vascular endothelial growth factor (VEGF), soluble VEGF-R2 and soluble KITa
timeFrame: 18-Nov-2008
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Fiedler W, Giaccone G, Lasch P, van der Horst I, Brega N, Courtney R, Abbattista A, Shalinsky DR, Bokemeyer C, Boven E. Phase I trial of SU14813 in patients with advanced solid malignancies. Ann Oncol. 2011 Jan;22(1):195-201. doi: 10.1093/annonc/mdq313. Epub 2010 Jul 6.