louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03604588: Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
Official title: Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oropharyngeal Cancer
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV


Eligibility criteria: Inclusion Criteria:

1. Untreated oropharynx epidermoid carcinoma
2. Patient ≥ 18 years old
3. Patient affiliated to a social security scheme or beneficiary of such a scheme
4. Information to the patient or his legal representative and signature of informed consent

Exclusion Criteria:

1. Non-oropharyngeal epidermoid carcinoma
2. Oropharyngeal epidermoid carcinoma previously treated

Primary outcomes:
measure: Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced.
timeFrame: up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy
state: Val De Marne
Study officials:
References:
Clinical trial NCT05607888: Prospective Study of Sinonasal and Skull-base Tumours Management
Official title: Prospective Observational Study of Sinonasal and Skull-base Tumours Management in a Tertiary Referral Otorhinolaryngology Service
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasal Neoplasm
Nasal Neoplasm Benign
Skull Base Neoplasms
Skull Base Osteomyelitis
Sinonasal Disorder
Sinus Disease
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
First posted: 2022-11-07
Enrollment: 120
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: The study population will be recruited from patients referred to the tertiary otorhinolaryngology referral centre. The referral applies to the in-hospital or outpatient setting.

Brief summary: This observational prospective clinical study aims to describe the epidemiology, management and outcome of patients with sinonasal and skull-base pathology (tumours and diseases with malignant clinical characteristics) in a tertiary otorhinolaryngology referral centre. The main questions it aims to answer are:

* what is the caseload of patients with the included pathology in our centre
* what are the results of management of these cases
* what are the epidemiological characteristics of included patients
* what is the quality of life of included patients.

Detailed description: Sinonasal tumours and tumours that involve the adjacent skull base are rare entities. However, their management necessitates a special knowledge of ENT areas and specifics of sinonasal anatomy and skull base. Due to the heterogeneity of pathological diagnoses of sinonasal and skull-base tumours, one of the main aims of this study is to provide epidemiological characteristics in our geographical area. Furthermore, to compare with other tertiary referral centres, we will analyse management results, which could improve the management of these diseases. Since the sinonasal area and skull base house several important neuroanatomical structures and senses, we aim to provide an analysis of the patient-reported quality of life.

Eligibility criteria: Inclusion Criteria:

* sinonasal and/or skull-base cancer
* sinonasal disease expanding through the skull-base
* the patient's written informed consent

Exclusion Criteria:

* lateral skull-base disease primarily originating in the temporal bone and without central skull-base involvement

Primary outcomes:
measure: Absence of the disease
timeFrame: twelve months after the treatment completion
measure: Overall survival
timeFrame: twelve months after the treatment completion
Secondary outcomes:
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: University Medical Centre Ljubljana
name: Domen Vozel, MD, PhD
role: STUDY_DIRECTOR
affiliation: University Medical Centre Ljubljana
name: Jure Urbančič, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01819688: Surgical Stress After Laparoscopic Compared to Open Liver Resection
Official title: Surgical Stress Induced Insulin Resistance and Cytokine Response After Laparoscopic Compared to Open Liver Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: laparoscopic liver resection
cytokine release
Lead sponsor: Sir Run Run Shaw Hospital
Sponsor class: OTHER
First posted: 2013-03-27
Enrollment: 52
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: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine whether the postoperative insulin resistance and cytokine release would be attenuated in laparoscopic compared with open liver resection.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* left hemihepatectomy(liver resection)
* left lateral sectionectomy(liver resection)

Exclusion Criteria:

* Patients with diabetes mellitus
* drug abuse
* BMI \>24 or \<18

Primary outcomes:
measure: postoperative insulin resistance calculated by serum insulin and blood glucose
timeFrame: within the first 72hrs after operation
Secondary outcomes:
measure: cytokine changement including IL-1β, IFN-γ, IL-4 and IL-10 before and after operation
timeFrame: within 5 days after operation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT05912088: Elderly Falls Prevention With sLiFE Program in Primary Care
Official title: Effectiveness of the sLiFE Program to Reduce Falls and Frailty in Elderly People in Primary Care. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Accidental Falls
Frailty
Elderly
Activities, Motor
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 650
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to guide older people living in the community on appropriate strategies within a fall prevention program. This program is aimed at training in daily activities carried out through group workshops (guided by a physiotherapist) and at preventing risk situations at home.

Detailed description: Two-arm, non-blind, non-inferiority experimental design. Multicenter, randomized trial.

The study tries to assess whether a group intervention following the principles of the sLiFE program is more effective than an usual health advice reducing the incidence of falls.

Eligibility criteria: Inclusion Criteria:

* People older than 65 years of age
* Living at home
* Speak and read Spanish

Exclusion Criteria:

* Heart failure (NYHA class III and IV)
* Recent stroke (\<6 months)
* Parkinson's disease
* In active cancer treatment (last 6 months)
* GOLD class III and IV chronic obstructive pulmonary disease
* Unstable lower extremity fracture
* Amputated lower extremity
* Treatment less than 6 months of depression
* Uncontrolled resting blood pressure of a systolic \> 160 or diastolic \> 100 or more
* Unavailability for intervention, planned travel or relocation more than 2 months within the first 6 months of the study
* Moderate to severe cognitive impairment (Mini Mental cognitive assessment \<23)
* Current participation in another interventional clinical trial

Primary outcomes:
measure: Incidence of falls
timeFrame: 6 months
measure: Physical activity
timeFrame: 8 days
measure: Physical activity
timeFrame: 6 months
measure: Frailty
timeFrame: 6 months
measure: Health effects
timeFrame: 6 months
Secondary outcomes:
measure: Fear of falling
timeFrame: 6 months
measure: Cognitive assessment
timeFrame: 6 months
measure: Motor function
timeFrame: 6 months
measure: Adherence to exercise
timeFrame: 6 months
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Primary Care Research Unit of Salamanca (APISAL)
Study officials:
affiliation: Primary Health Care Research Unit
name: Luis García-Ortiz, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT06913088: Ultrasonication-mediated Microbubbles Dressing for Hand Arthritis
Official title: Ultrasonication-mediated Microbubbles Dressings Increase the Therapeutic Efficacy of Piroxicam Gel for Hand Arthritis: Assessments Using Conventional and Ultrafast Power Doppler Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hand Arthritis
Lead sponsor: National Taiwan University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to learn if ultrasonication-mediated microbubbles dressing works to treat hand arthritis in adults. It will also learn about the safety of ultrasonication-mediated microbubbles dressing. The main questions it aims to answer are:

Does ultrasonication-mediated microbubbles dressing increase the therapeutic efficacy of piroxicam gel for hand arthritis?

Researchers will compare "ultrasonication-mediated microbubbles dressing + piroxicam gel " to "ultrasonication + piroxicam gel" and "piroxicam gel alone" to see if ultrasonication-mediated microbubbles dressing works to treat hand arthritis.

Participants will:

Take "ultrasonication-mediated microbubbles dressing (day 1,3,5) + piroxicam gel (day 2,4,6,7) ", "ultrasonication (day 1,3,5) + piroxicam gel (day 2.4.6.7)", and "piroxicam gel alone (day 1-7)" for 1 week.

Visit the clinic on day 1 and day 8 for checkups and tests Keep a diary of their symptoms


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of hand arthritis
* Have at least three symptomatic joints over wrist, metacarpophalangeal joints, and interphalangeal joints

Exclusion Criteria:

* Infectious arthritis
* Acute gout

Primary outcomes:
measure: Clinical response
timeFrame: day 8
measure: B-mode response
timeFrame: day 8
measure: Conventional power Doppler (PD) response
timeFrame: day 8
Secondary outcomes:
measure: Ultrafast PD response
timeFrame: day 8
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
References:
Clinical trial NCT04188288: Neurofeedback in Individuals With Substance Use Disorders
Official title: Neurofeedback in Individuals With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to train individuals with opioid use disorder to control their brain activity in a way that has been associated with their symptoms. Participants in the experimental group will be given direct feedback regarding their brain activity while they are undergoing functional magnetic resonance imaging (fMRI) scanning, and will try to learn to control their brain activity during these feedback sessions. A separate group of participants will be given a control form of feedback that we do not believe can have clinical benefits. Our primary hypothesis is that the neurofeedback training will reduce opioid use and clinical features of opioid use disorder more than the control feedback.


Eligibility criteria: Inclusion Criteria:

1. non-methadone opioid positive urine screen (as assessed during standard treatment) or indicated via Utox or self-reported past-month opioid use at screening
2. Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for opioid use disorder, as assessed via structured clinical interview (SCID)
3. ≥3 months of methadone treatment

Exclusion Criteria:

1. Having any current neurologic or psychiatric disorders including current moderate to severe other DSM-5 substance use disorders with the exceptions of opioids, cocaine, tobacco and cannabis, as assessed using the SCID.
2. Failure to pass a magnetic resonance imaging (MRI) screening
3. Having significant underlying medical conditions requiring medications.
4. Women who are pregnant or nursing
5. Baseline scanning with excessive motion based on frame to frame displacement

Primary outcomes:
measure: Opioid Use: Urine Tests
timeFrame: Baseline (week 1) to one month post follow-up (week 9)
measure: Opioid Use: Timeline Followback Method (TLFB)
timeFrame: Baseline (week 1) to one month post follow-up (week 9)
Secondary outcomes:
measure: Mean Change in Functional Connectivity Patterns in the Brain
timeFrame: Baseline (week 1) through follow up (week 5)
measure: Mean Opioid Craving Score
timeFrame: Baseline (week 1) to one month post follow-up (*week 9*)
measure: Negative Affect Mean Score
timeFrame: Baseline (week 1) to one month post follow-up (week 9)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen Garrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04927988: Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion
Official title: Blood Components Changes by Using of Ringer's Lactated as Detergent In Autologous Blood Cell Transfusion: A Prospective, Single-center, Open, and Single-arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Placenta Accreta Spectrum
Keywords: Placenta Accreta Spectrum
Autologous Blood Cell Transfusion
Blood Components
Lead sponsor: Maternal and Child Health Hospital of Foshan
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Placenta accreta spectrum (PAS) disorders are associated with increased maternal morbidity and mortality related to life-threatening hemorrhage, and greater potential need for blood transfusion. Clinical evidences have confirmed that the use of autologous blood cell transfusion is safe and effective for patients with obstetric haemorrhage. Normal saline is the solution recommended for red cell washing, administration and salvage. However, there is growing concern that normal saline is more toxic than balanced, buffered crystalloids such as Lactated Ringer's and Plasma-Lyte. The purpose of this study is to evaluate the blood components using of Ringer's Lactated by a prospective, single-center, open, and single-arm clinical trial.


Eligibility criteria: Inclusion Criteria:

* Between 18 and 45 years old
* Without health problem nor disease requiring regular medical treatment

Exclusion Criteria:

* subject with contraindication for drawing blood
* Subject with physical or mental disability or restriction of liberty that would prevent autotransfusion

Primary outcomes:
measure: Change in hematological parameters
timeFrame: Baseline (Day 1), until 2 days after autotransfusion
measure: Change in hematological parameters
timeFrame: Baseline (Day 1), until 2 days after autotransfusion
measure: Change in hematological parameters
timeFrame: Baseline (Day 1), until 2 days after autotransfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Foshan
country: China
facility: Maternal and Child Health Hospital of Foshan
state: Guangdong
Study officials:
References:
Clinical trial NCT03382288: Clinical Trial ES 900 - 2016
Official title: Clinical Trial ES 900 - 2016
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Optical Biometry of the Human Eye
General Analysis of the Anterior Chamber of the Human Eye
Lead sponsor: Haag-Streit AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2017-12-22
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The primary objective of this clinical trial is to assess the clinical performance of the investigational device. To that end, for each measure and the in-vivo repeatability will be quantified, as well as the mean measurement deviation with respect to the current gold standard device. As a secondary objective of the study, raw measurement data will be collected, to allow for improvements of existing algorithms, development of additional measure and and for retrospective analysis.

Detailed description: EYESTAR 900 (the investigational device) is a new device by HAAG-STREIT AG, for measurement of optical biometry and advanced corneal topography by swept-source optical coherence tomography (OCT).

Eligibility criteria: Inclusion Criteria:

* 18 years or older;
* volunteers with phakic eyes, no cataract surgery indicated and with existing vitreous;
* patients seeking cataract surgery;
* patients with pseudophakic eye;
* patients with oil-filled eye;
* patients with aphakic eye.

Exclusion Criteria:

* underage patients (younger than 18 years);
* vulnerable patients;
* inability to give informed consent;
* inability to maintain stable fixation.

Primary outcomes:
measure: Keratometry-Measurands
timeFrame: Through study completion, approximately 9 months.
measure: Axial measurands
timeFrame: Through study completion, approximately 9 months
measure: Imaging
timeFrame: Through study completion, approximately 9 months
measure: Anterior corneal topography
timeFrame: Through study completion, approximately 9 months
measure: Posterior corneal topography
timeFrame: Through study completion, approximately 9 months
measure: Corneal pachymetry
timeFrame: Through study completion, approximately 9 months
measure: Posterior corneal keratometry
timeFrame: Through study completion, approximately 9 months
Secondary outcomes:
measure: Aquisition of volumetric OCT Data of the eye.
timeFrame: Through study completion, approximately 9 months
measure: Aquisition of photographic images of the eye.
timeFrame: Through study completion, approximately 9 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: David Goldblum, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394388: A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)
Official title: A Cultural Adaptation of the Caregiver TLC Psychoeducational Program to Support Latino Caregivers (CUIDANDO JUNTOS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers of People With Dementia
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Charlotte
name: National Institute on Aging (NIA)
First posted: 2024-05-01
Enrollment: 28
Sex: ALL
Minimum age (years): 39
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study will test the feasibility and influence of a behavioral intervention called "Cuidando Juntos" in Latino caregivers of people with dementia. The study will examine if the intervention is well received by Latino caregivers and if the caregivers' social connectedness and loneliness is associated with their levels of stress, burden, and depression.


Eligibility criteria: Inclusion Criteria:

* Spanish speaking
* Latino caregivers are those who identify as the primary caregivers of a person with dementia, with whom they co-reside or live close by.
* must have an email address and access to the internet
* Caregivers should report at least a moderate level of stress

Exclusion Criteria:

* None

Primary outcomes:
measure: Mean change in PHQ-9 to assess depressive symptoms
timeFrame: Baseline to six weeks
measure: Mean change in Perceived Stress Scale
timeFrame: Baseline to six weeks
measure: Mean change in Zarit Caregiver Burden 6-item version
timeFrame: Baseline to six weeks
measure: Mean change in Caregiver Self-Efficacy Scale (CSES-8)
timeFrame: Baseline to six weeks
measure: Mean change in UCLA Loneliness Scale
timeFrame: Baseline to six weeks
measure: Mean change in Social Network Scale
timeFrame: Baseline to six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: University of North Carolina, Charlotte
state: North Carolina
Study officials:
References:
Clinical trial NCT02734888: Arterial Inflammation and E-Cigarettes
Official title: Arterial Inflammation and E-Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Inflammation
Keywords: arterial inflammation
electronic cigarettes
PET scan
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-04-12
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2) Tobacco cigarette smokers, 3) Electronic cigarette users.

Detailed description: Qualified participants will undergo a singe PET/CT to detect arterial inflammation.

Eligibility criteria: Inclusion Criteria:

Healthy

* Nonsmokers OR
* Daily e-cigarette user OR
* Daily tobacco cigarette smoker

Exclusion Criteria:

* Cardiac disease
* Respiratory Disease
* Diabetes mellitus

Primary outcomes:
measure: target-to-background ratio (TBR)
timeFrame: intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCaliforniaLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Holly R Middlekauff, MD
role: PRINCIPAL_INVESTIGATOR
References: