louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06899516: Project MILANO: Connections Between Patients With Brain Tumors and Their Pets: an Analysis of Concerns and Needs
Official title: Project MILANO: Connections Between Patients With Brain Tumors and Their Pets: an Analysis of Concerns and Needs
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain (Nervous System) Cancers
Keywords: Brain tumors
Glioma patients
Pet care
Emotional burden
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with a brain tumor who have one or more pets will be included.

Brief summary: Context and problem

In France, 61% of households own a pet, highlighting the significant role pets play in the daily lives. Patients diagnosed with brain tumors face specific challenges that may affect their ability to care their pets, including:

* Progressive neurological deficits (cognitive and/or motor), limiting their autonomy,
* A life-threatening prognosis.

In this context, the well-being of pets when their owner's health deteriorates becomes a critical concern. Indeed:

* Social isolation and the progressive loss of physical and cognitive abilities complicate pet care, particularly during prolonged hospitalizations or in the event of death,
* The lack of appropriate facilities and care solutions causes stress for pets, who are often unprepared for such transitions, and adds to the emotional burden on patients.

Why focus on patients with brain tumors?

* These patients have specific needs due to the rapid progression of their condition,
* A local study showed that 12% of patients with gliomas live alone, a significantly higher rate than in other cancer types. Patients who live alone are particularly exposed to issues related to their pet's future,
* Given the high morbidity and mortality associated with brain tumors, proactive planning for pet care is particularly urgent.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with a brain tumor.
* Patients who own at least one pet.

Exclusion Criteria:

* Patients who decline to participate in the study.
* Patients unable to complete the questionnaire.

Primary outcomes:
measure: LAPS scale
timeFrame: Day 1
Secondary outcomes:
measure: Questionnaire
timeFrame: Day 1
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint Etienne
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Carole Ramirez, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04380116: Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Official title: Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 96
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD).

The specific AIMS will be:

1. To determine the effectiveness of Soberlink's ability to increase abstinence
2. To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety.
3. To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for individuals who have had access to the Soberlink device.


Eligibility criteria: Inclusion Criteria:

* are at least 21 years old,
* currently enrolled at Aware In home treatment,
* Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD).

Exclusion Criteria:

* Current suicide or homicide risk,
* meet criteria for DSM-IV current psychotic disorder, or bipolar disorder,
* does not have phone access with text message capabilities
* Unable to read or understand English,
* Unable to complete the study because of anticipated incarceration or move,
* Life-threatening or unstable medical problems,
* No course of current or pending legal action,
* Soberlink results being used for child custody or legal circumstance.

Primary outcomes:
measure: Alcohol Time Line Follow Back (TLFB)
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Quality of Life Survey
timeFrame: up to 24 weeks
measure: Mean Positive BAC Response With Soberlink
timeFrame: up to 24 weeks
measure: Alcohol Abstinence Self-efficacy Scale for Temptation.
timeFrame: up to 24 weeks
measure: Alcohol Abstinence Self-efficacy Scale for Confidence
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: North Haven
country: United States
facility: Aware Recovery Care
state: Connecticut
Study officials:
References:
citation: Buono FD, Gleed C, Boldin M, Aviles A, Wheeler N. Preliminary Effectiveness of a Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e30186. doi: 10.2196/30186.
Clinical trial NCT05105516: Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs
Official title: Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and Effect Effect of Ablation and Comparison Between Different Sites of Ablation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiomyopathies
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diagnosis Of Early Cardiac Dysfunction in Patients With Idiopathic Frequent Monomorphic PVCs and effect of ablation and comparison between different sites of ablation

Detailed description: * Apply the speckle myocardial tracking technology to early diagnose dysfunction in patients with idiopathic frequent monomorphic PVCs
* Assessment of cardiac function before and after ablation and comparison before and after ablation and between sites of origin of the PVCs as diagnosed by the electrophysiologic and 3d mapping techniques that may be more confirmed by successful ablation whenever achieved

Eligibility criteria: Inclusion Criteria:

* All patients of sample size admitted to the cardiology department of Assiut university hospital for ablation of idiopathic frequent monomorphic PVCs

Exclusion Criteria:

* Patients with well-known factors of cardiac dysfunctions, including high blood pressure (over 140/90 mmHg), hypertrophic cardiomyopathy, left ventricular hypertrophy, bundle branch block, severe valvular disease, complete heart block, and previous CABG.

Primary outcomes:
measure: • Detection of early cardiac dysfunction in patients with idiopathic frequent monomorphic PVCs .
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Latchamsetty R, Bogun F. Premature Ventricular Complex-Induced Cardiomyopathy. JACC Clin Electrophysiol. 2019 May;5(5):537-550. doi: 10.1016/j.jacep.2019.03.013.
citation: Sharma E, Arunachalam K, Di M, Chu A, Maan A. PVCs, PVC-Induced Cardiomyopathy, and the Role of Catheter Ablation. Crit Pathw Cardiol. 2017 Jun;16(2):76-80. doi: 10.1097/HPC.0000000000000106.
Clinical trial NCT05390216: Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement
Official title: Impact of Partial Capsule Decortication on Device-related Infection in Patients Receiving Cardiac Implantable Electronic Device Replacement: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pacemaker Complication
Infections
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 1016
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: Increasing number of cardiac implantable electronic devices (CIEDs) have been implanted in the worldwide every year, which is accompanied by the growing number of CIED-related infection, especially in patients with CIED replacement. This multicenter, prospective, single-blinded, randomized controlled trial is to confirm the impact of partial capsule decortication on device-related infection in patients receiving CIED replacement.


Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is planned to undergo at least one of the following procedures:

  a) Patient has existing CIED (pacemaker, or CRT-P, or ICD, or CRT-D) and is undergoing pulse generator replacement or upgrade with a new generator. b) Patients planned to have leads added, or extracted and added for upgrades.
* Patient is willing to sign and date informed consent

Exclusion Criteria:

* History of CIED-related infection
* Open the pocket for any reason within the last one year
* Any evidence indicating active infection
* Requirement of long term vascular access for any reason
* Expected survival time is less than one year
* Patients who were pregnant or breastfeeding
* Participation in another study that may confound the results of this study
* Patient is unable to comply with scheduled follow up

Primary outcomes:
measure: Rate of major CIED-related infection
timeFrame: Within the first year after the operation
Secondary outcomes:
measure: Rate of minor CIED-related infection
timeFrame: Within the first year after the operation
measure: Rate of all CIED-related infection
timeFrame: Within the first year after the operation
measure: Rate of pocket hematoma
timeFrame: Within the first year after the operation
measure: Rate of device dysfunction
timeFrame: Within the first year after the operation
measure: All-cause mortality
timeFrame: Within the first year after the operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
state: Shanghai
Study officials:
References:
Clinical trial NCT05508334: A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours
Official title: An Open-label, Non-randomised, Multicentre Study to Allow Continued Access to and Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumours
Lead sponsor: RemeGen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to allow RC88 treatment of patients with advanced solid tumours to assess the safety and tolerability of clinical pharmacology studies

Detailed description: The main purpose of this Phase I study is to test RC88 at different dose levels to see if it is safe and well tolerated when given once every 2 weeks.

Eligibility criteria: Inclusion Criteria:

1. All subjects must be ≥ 18 years at the first screening examination / visit.
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
3. Life expectancy of at least 12 weeks
4. Phase I must be histologically or cytologically confirmed and have failed standard therapy (disease progression after treatment) or are intolerant,unable to receive, or nonexistent to standard care,Patients with partial,advanced or metastatic malignant solid tumors;
5. Phase II-Advanced malignant solid tumor with MSLN expression
6. Patients with malignant pleural mesothelioma were assessed using mRECIST criteria, and those with other cancers were assessed using RECIST V1.1 criteria
7. Phase II-Mesothelin (MSLN) positive as confirmed by the central laboratory.
8. Adequate organ function
9. Voluntarily sign an informed consent form

Exclusion Criteria:

1. Cancer metastases in the brain
2. Active infection or past hepatitis B or C infection
3. Major surgery less than 1 month before the start of the study
4. Uncontrolled heart disease
5. History of allergy to mesothelin-directed antibodies, tubulysin, monoclonal antibodies related compounds

Primary outcomes:
measure: RP2D
timeFrame: 28 days after first treatment
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 24 months
measure: Maximum Concentration (Cmax) of RC88
timeFrame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours
measure: Terminal Half Life (t1/2) of RC88
timeFrame: pre-dose, 0.5, 1, 1.5, 2, 3, 5, 8, 24, 48, 96, 168 hours
measure: Progression Free Survival (PFS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Remegen
state: Beijing
city: Beijing
country: China
facility: Remgenen
state: Beijing
Study officials:
References:
Clinical trial NCT02245334: A Prospective Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Official title: A Prospective Randomized Trial of Povidone-iodine Suppository Before Transrectal Ultrasound Guided Prostate Biopsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infection
Prostatic Diseases
Misadventure During Aspirating Needle Biopsy
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 1578
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

Detailed description: the effect of povidone-iodine on infectious complication rate caused by transrectal prostate biopsy

Eligibility criteria: Inclusion Criteria:

* who undergo transrectal prostate biopsy

Exclusion Criteria:

* patients who refuse to be included, patients who have hypersensitivity to iodine, patients who have abnormal thyroid function, patients who do not visit follow-up, patients who have received prior radioactive-iodine therapy

Primary outcomes:
measure: Number of participants with febrile infection
timeFrame: 1 week
Secondary outcomes:
measure: voiding questionnaire
timeFrame: 1-2 week
measure: sexual function questionnaire
timeFrame: 1-2 week
measure: quality of life questionnaire
timeFrame: 1-2 week
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Department of Urology, Seoul National University Bundang Hospital
state: Gyunggi-do
Study officials:
affiliation: Prof
name: Sangchul Lee, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02830217: Evaluation of Soluble ST2 in Patients Receiving Primary PCI With ST-elevation Myocardial Infarction
Official title: Using Soluble ST2 to Predict Clinical Outcomes in Patients Receiving Primary Percutaneous Coronary Intervention With ST-elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Shock
Keywords: STEMI
primary PCI
sST2
prognosis
Lead sponsor: Wuhan Asia Heart Hospital
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese han population in middle China

Brief summary: ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients are readmitted shortly after the primary PCI for several unfavorable clinical outcomes including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart failure. This study is intended to test the predictive ability of a new biomarker soluble ST2 (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly associated with unfavorable clinical outcomes of patients with ischemia heart diseases and heart failure. This study will further investigate the ability of sST2 to predict unfavorable outcomes for STEMI patients after primary PCI.


Eligibility criteria: Inclusion Criteria:

* Patients with first onset STEMI receive primary PCI according to 2013 ACCF/AHA guideline for management of STEMI

Exclusion Criteria:

* Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases or severe infection are excluded from this study.

Primary outcomes:
measure: stent restenosis
timeFrame: one year after primary PCI
measure: recurrence of myocardial infarction
timeFrame: one year after primary PCI
measure: heart failure
timeFrame: one year after primary PCI
measure: cardiac death
timeFrame: one year after primary PCI
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
Study officials:
affiliation: Wuhan Asia Heart Hospital
name: Xuan Zheng, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06437717: Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery
Official title: Role of Nanoemulsified Sesame Oil in Post-operative Care After Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of our thesis is to design, develop and characterize a novel thermodynamically stable NE by spontaneous method intended for topical use. Subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in CRS patients who have undergone ESS (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.


Eligibility criteria: Inclusion Criteria:

1. Patient age between 18 and 60 years old.
2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery.

Exclusion Criteria:

1. Patients with history of allergy for sesame seed derivatives.
2. Patients with chronic diseases which affecting the process of healing (uncontrolled DM, renal failure and hepatic failure).
3. Patients with nasal granulomas.
4. Patients with invasive fungal rhinosinusitis.
5. Smokers.
6. Patients with history of radio and/or chemotherapy exposure.
7. Patients with systemic diseases affecting integrity of nasal mucosa (e.g. CF, scleroderma, Sjogren syndrome ...).

Primary outcomes:
measure: Sinonasal Outcome Test 22 (SNOT-22)
timeFrame: weekly for three months
measure: Lund-Kennedy endoscopic grading system
timeFrame: once monthly for three months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahliya
Study officials:
References:
Clinical trial NCT02982317: Automated UltraSound Software for Identification of Lumbar Vertebral Levels
Official title: Automated UltraSound Software for Identification of Lumbar Vertebral Levels in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: Neuraxial anesthesia
Obstetrics
Ultrasound
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-12-05
Enrollment: 77
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients scheduled for an elective Cesarean section at BC Women's Hospital

Brief summary: A novel automated ultrasound software system has been developed which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aims to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

Detailed description: The use of ultrasound is one of the most accurate ways to identify the correct vertebral level for needle insertion in spinal/epidural anesthetics, however this is not commonly used. A novel automated ultrasound software system has been developed by the UBC Department of Engineering which identifies for the practitioner the intervertebral spaces in the lumbar area. This study aim to investigate whether this new technology has a greater accuracy of identifying intervertebral spaces that manual palpation.

Eligibility criteria: Inclusion Criteria:

* ASA I or II
* ≥ 19 years old
* Term pregnancy (≥ 37 weeks gestation age)
* Scheduled for elective Cesarean section
* Ability to read English in order to understand the consent form

Exclusion Criteria:

* Patient refusal to participate
* BMI ≥ 40
* Scoliosis
* Previous lower back surgery or known spinal abnormalities
* Inability to palpate bony landmarks in lumbar region
* Active labour (cervical dilatation \>5cm)
* Allergy to epidural tape, surgical paper tape, or felt pen

Primary outcomes:
measure: Accuracy of identifying L3/L4 of agreement between the two techniques against the freehand US (control)
timeFrame: Within 1 hour of recuitment
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: Univeristy of British Columbia
name: Anton Chau, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hetherington J, Brohan J, Rohling R, Gunka V, Abolmaesumi P, Albert A, Chau A. A novel ultrasound software system for lumbar level identification in obstetric patients. Can J Anaesth. 2022 Oct;69(10):1211-1219. doi: 10.1007/s12630-022-02300-6. Epub 2022 Aug 9.