louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05598983: Non-contact Proactive Remote Monitoring of COPD Exacerbations
Official title: Non-contact Proactive Remote Monitoring to Facilitate Early Detection of Exacerbations in Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD Exacerbation
Lead sponsor: Life Detection Technologies
Sponsor class: INDUSTRY
Collaborators: name: Royal Free Hospital NHS Foundation Trust
First posted: 2022-10-31
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of death affecting an estimated 238 million worldwide. It is a heterogeneous disease which is characterized by air flow obstruction and decline in lung function with symptoms of shortness of breathing, sputum, and cough.

Brief summary: The goal of this observational study is to determine if a COPD exacerbation can be detected early in its onset. The main questions it aims to answer are:

* Can an exacerbation be detected before the person recognizes they are unwell?
* What are the biological signals which provide the best indication of decompensation?
* How does this indication of decompensation compare to a daily CAT?

Participants will be asked to place a device, DistaSense, on top of their mattress and then sleep as normal. In addition, they will be asked to complete a daily CAT.


Eligibility criteria: Inclusion Criteria:

1. Confirmed diagnosis of COPD
2. 1 or more exacerbation in the last year
3. Aged over 18 years
4. Willing to use monitoring devices and complete study questionnaires
5. Adequate English
6. Signed consent form

Exclusion Criteria:

1. Pregnancy
2. BMI greater than 45 kg/m2
3. Nil other, provided inclusion criteria are met.

Primary outcomes:
measure: Track the adherence of DistaSense
timeFrame: 12 months
measure: Understand the patient acceptance of DistaSense
timeFrame: 12 months
measure: Ability to detect COPD exacerbations
timeFrame: 3 - 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: University College, London
name: John Hurst
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03538483: Erector Spinae Plane Block Versus Serratus Plane Block for Breast Surgery
Official title: Erector Spinae Plane Block Versus Serratus Plane Block on Postoperative Opioid Consumption for Modified Radical Mastectomy and Axillary Lymph Node Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Breast Cancer
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Serratus plane block (SPB) was first described in 2013 by Blanco and designed to primarily block the thoracic intercostal nerves. And this block provides sufficient analgesia lateral anterior and posterior part of thoracic wall.Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery. It was first described by Forero et al. in 2016, effectiveness being reported in four cases. The aim of this study is to compare Serratus plane block and erector spinae plane block on postoperative pain in patients undergoing modified radical mastectomy and axillary lymph node dissection


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* undergoing breast cancer surgery
* 18-65 years

Exclusion Criteria:

* chronic pain
* bleeding disorders
* renal or hepatic insufficiency
* patients on chronic non-steroidal anti-inflammatory medications
* emergency cases
* coagulopathy

Primary outcomes:
measure: Opioid Consumption
timeFrame: First 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postoperative first24 hours
measure: Block Performing Time
timeFrame: First hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
Clinical trial NCT04220983: PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
Official title: PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Prostate Cancer
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.

Detailed description: The MRidian ViewRay offers delivery of prostate SBRT with real-time MR guidance, which provides superior soft-tissue differentiation with excellent visualization of the prostate. This ViewRay platform offers the ideal setting for this study, that aims at precisely delivering prostate SBRT with a simultaneous integrated boost (when indicated) to visible nodules.

In this study, we hope to demonstrate the safety and feasibility of using 36.25 Gy in 5 fractions, plus a simultaneous integrated boost (when indicated), in patients with metastatic prostate cancer.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proven diagnosis of prostate adenocarcinoma
* Age ≥ 18
* Must have biopsy-proven metastatic prostate cancer

Exclusion Criteria:

* History of prior pelvic radiation (external beam or brachytherapy)
* Inability to undergo MRI
* AUA score \>20
* For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.

Primary outcomes:
measure: Change in Number of Subjects With Adverse Events Will be Collected
timeFrame: baseline, 3-6months and at 9-12 months.
Secondary outcomes:
measure: Change in Quality of Life Questionnaires Will be Assessed.
timeFrame: baseline, 3-6months and at 9-12 months.
measure: Change in The International Prostate Symptom Score (I-PSS) Will be Assessed.
timeFrame: baseline, 3-6months and at 9-12 months.
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Silvia Formenti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01515683: Behavioral Support Before Anesthesia
Official title: Behavioral Support to Cancer Patients Before Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nervousness
Life Experiences
Keywords: Nervousness before anesthesia
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 350
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Studies shows that reduced nervousness before anaesthesia may improve a course past anaesthesia. Therefore it is interesting to investigate how we can best help patients shortly before anaesthesia. A RCT with three intervention arms (with different personal support) and a control arm (with usual personal support) is therefore performed.

Hypothesis: Nervousness is reduced by the new interventions compared to the usual help provided.

Detailed description: All patients receive behavioral support the last half hour before anaesthesia, but at different times and provided by persons with different connection to the patients.

The last two patients in all arms will be interviewed about their experiences with the help offered.

Statistic will provide results in the quantitative part of the study and analysis and interpretation following ideas of the French philosopher Poul Ricoeur will provide results in the qualitative part of the study.

Eligibility criteria: Inclusion Criteria:

* All Danish-speaking expected gynaecological cancer patients, who are offered open surgery at Odense University Hospital, who can speak for themselves and have the opportunity to have close relative to follow before anaesthesia and who accept participation.

Exclusion Criteria:

* Senility

Primary outcomes:
measure: Change from baseline in nervousness at the operating table
timeFrame: Baseline and when the patient is on the operating table, on average 1½ days
Secondary outcomes:
measure: Satisfaction with help from healthcare professionals
timeFrame: A questionnaire at discharge, an expected average of three days
measure: Healthcare professional time spent
timeFrame: The last half an hour before anaesthesia
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Gynækologisk obstetrisk afdeling D, Odense Universitetshospital
state: Fyn
Study officials:
affiliation: Southern University of Denmark
name: Ole Mogensen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01863147: Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Official title: Sitagliptin Reduces Left Ventricular Mass in Normotensive Type 2 Diabetic Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Newly Diagnosed Type 2 Diabetes
Coronary Artery Disease
Keywords: Type 2 diabetes
left ventricular mass
inhibitor of dipeptidyl peptidase-4
Lead sponsor: Wuhan General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 66
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiovascular complications account for the highest mortality in type 2 diabetic patients, mainly due to coronary artery disease (CAD).Left ventricular hypertrophy (LVH) is widespread in type 2 diabetic patients with CAD, even in the absence of hypertension .It is a strong predictor of cardiovascular events and all-cause mortality .

Sitagliptin, an inhibitor of dipeptidyl peptidase-4 (DPP-4), may regress left ventricular mass (LVM) in newly diagnosed type 2 diabetic patients with CAD .


Eligibility criteria: Inclusion Criteria:Patients had to have the levels of hemoglobin A1c (HbA1c) \> 7.0 %. They also had to have either angiographically documented coronary artery disease or a previous history of myocardial infarction. In addition, they were also required to have an office BP \< 135/85 mm Hg and the presence of LVH on echocardiography (American Society of Echocardiography criteria LVM index \[LVMI\] \> 115 g/m2 for men and \> 95 g/m2 for women) . -

Exclusion Criteria:Patients were excluded if they were currently prescribed glucagon-like peptide (GLP) -1 analogues or DPP-4 inhibitors or glucosidase inhibitor or anti-hypertensive drugs (including b-blockers), diabetes medications, estrogen supplements, thyroxine, diuretics, hypolipidemic drugs. They were also excluded if they had renal and liver dysfunction, heart failure, or malignancy, or were unable to give informed consent. Patients with contraindications to cardiac magnetic resonance (CMR) (pacemakers, claustrophobia) were also excluded, as were pregnant or lactating women. -

Primary outcomes:
measure: Left ventricular mass and left ventricular volume
timeFrame: 2013~2014(follow up 1 year)
Secondary outcomes:
measure: Endothelial function and augmentation index (AIx)
timeFrame: 2013~2014 (follow up 1 year)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Guangda Xiang
state: Hubei
city: Wuhan
country: China
facility: Wuhan General Hospital
state: Hubei
Study officials:
affiliation: Wuhan General Hospital of Guangzhou Command
name: Xiang Guangda, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06774677: Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management
Official title: Decoding the Extracellular Vesicles-driven Communication in the Microenvironment of Hairy Cell Leukemia to Improve Patient Care Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hairy Cell Leukemia (HCL)
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be composed by Hairy Cell Leukemia patients subdivided as newly diagnosed (n=10), relapsed meeting treatment indications (N=5) and in complete response \>2 years (N=10) and by Healthy Donors (n=25), enrolled among volunteers through the non-profit organization AIL Bologna ODV.

Brief summary: This is a national multi-centre, experimental, cross-sectional, non-profit study.

Detailed description: Extracellular vesicles are small particles circulating in plasma and documented as key players of intercellular crosstalk thanks to their cargo of proteins, lipids, and nucleic acids. The driving hypothesis of this study is that in Hairy Cell Leukemia-derived extracellular vesicles contribute to the maintenance of the tumor clone through regulation of selected key cells of the tumor microenvironment including immune cells and stromal cells, likely favoring immune evasion and marrow fibrosis. As a consequence, these circulating particles may be instrumental at identifying a biology-related, disease-specific and extracellular vesicle-based signature associated to outcomes.

Eligibility criteria: Inclusion criteria for patients:

* WHO2022-defined diagnosis of Hairy Cell Leukemia.
* Age ≥18 years.
* Signed informed consent.

Inclusion criteria for Healthy Donors:

* Age ≥18 years.
* Volunteers in general good health, free from any disease or serious illness.
* Signed informed consent.

Exclusion criteria

- None

Primary outcomes:
measure: Extracellular vesicle characterization
timeFrame: 1 years
Secondary outcomes:
measure: Functional effects of extracellular vesicles
timeFrame: 1 years
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
state: PA
city: Siena
country: Italy
facility: Policlinico Santa Maria alla Scotte
state: SI
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Lucia Catani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04597177: SW-IMRT Versus ST-IMRT in the Treatment of Head and Neck Cancer
Official title: Swallowing Sparing IMRT (SW-IMRT) Versus Standard Parotid Sparing IMRT (ST-IMRT) in the Treatment of Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Swallowing Dysfunction
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To clinically validate whether SW-IMRT actually reduce the occurrence of swallowing dysfunction as compared to ST-IMRT.

Detailed description: Patients are randomly assigned to either ST-IMRT or SW-IMRT.

Eligibility criteria: Inclusion Criteria:

* Patients with squamous cell carcinoma and requiring whole neck irradiation as a part of either definitive RT alone or in combination with chemotherapy or post-operative RT either alone or in combination with chemotherapy.

Exclusion Criteria:

* Previous radiotherapy to the head and neck region or prior malignancies, and/or distant metastases.

Primary outcomes:
measure: Subjective assessment of the swallowing function (dysphagia) at regular intervals
timeFrame: 6 months
measure: Objective assessment of the swallowing function (dysphagia) at regular intervals
timeFrame: 6 months
Secondary outcomes:
measure: local control
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: May Ashour
Study officials:
References:
Clinical trial NCT01409577: Outcome of FFR-guided Intervention Strategy
Official title: Clinical Outcome of Fractional Flow Reserve-guided Coronary Intervention Strategy in Koreans
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary stenosis
stent
fractional flow reserve
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ajou University
name: Keimyung University Dongsan Medical Center
name: Inje University
First posted: 2011-08-04
Enrollment: 1500
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 with intermediate coronary stenosis by visual estimation

Brief summary: The investigator will evaluate the clinical outcomes of the patients in whom the treatment strategy for their coronary stenosis were determined by fractional flow reserve measurement.

Detailed description: Inclusion criteria

* Coronary stenosis
* Successful measurement of fractional flow reserve

Clinical outcomes

* Death
* Cardiac death
* Target lesion revascularization
* Target vessel revascularization

Eligibility criteria: Inclusion Criteria:

* Coronary stenosis
* Successful fractional flow reserve measurement

Exclusion Criteria:

* Contraindication to adenosine
* Expected life expectance \< 1year

Primary outcomes:
measure: Long-term MACE
timeFrame: 5 years
Secondary outcomes:
measure: Short-term MACE
timeFrame: 9 months
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: Ilsan Paik hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06184477: The Relationship Between Prolonged Hospitalization and Surgical Experience in Pediatric Tonsillectomy Cases.
Official title: Pediatric Tonsillectomy: Surgical Experience And Prolonged Hospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea
Tonsillitis Recurrent
Keywords: Tonsillectomy
Prolonged hospitalization
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 350
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A retrospective analysis was conducted on tonsillectomy patients under the age of 18, who underwent surgery at our clinic between 2019 and 2023.

Brief summary: Guided by the expertise of a seasoned surgeon at the tertiary care hospital, the training program includes performing tonsillectomy starting from the 6th month. The clinical protocol at the hospital dictates a standard one-night hospital stay for all patients, but there is potential to extend the duration in specific cases. The study endeavors to explore the correlation between extended hospitalization, surgical proficiency, patient-specific factors, and postoperative complications in pediatric patients who underwent tonsillectomy and/or adenotonsillectomy at the clinic.


Eligibility criteria: Inclusion Criteria:

* Patients under 18 years of age having tonsillectomy surgery
* Patients whose records are available in the hospital archive

Exclusion Criteria:

* Inadequate information in files

Primary outcomes:
measure: Incidence of hospitalization lasting more than 24 hours
timeFrame: december'23- january'24
Secondary outcomes:
measure: Incidence of postoperative complications
timeFrame: december'23- january'24
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT06307977: Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
Official title: Couples Motivational Interviewing to Reduce Drug Use and HIV Risk in Vulnerable Male Couples
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
HIV Infections
Lead sponsor: Hunter College of City University of New York
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-03-13
Enrollment: 360
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study utilizes a randomized controlled trial design to evaluate the efficacy of couples motivational interviewing (MI) to reduce the frequency and severity of illicit drug use and frequency of HIV transmission risk behavior (TRB). Participants are randomized to one of two conditions: couples MI or standard couples HIV testing and counseling (CHTC).


Eligibility criteria: Inclusion Criteria:

* Have a main partner who is another cisgender male and have been in a relationship for 3 month or longer
* Index participant must be between 18 and 55; Main partner can be any age 18 and older
* One participant must be HIV negative (as confirmed by rapid test)
* One participant must have used at least 1 drug in the past 30 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB, amyl nitrite)
* Index participant must have engaged in TRB in the past 30 days- Defined as CAS with a casual partner, or a serodiscordant or non-monogamous main partner
* Live in the United States
* Speak and read English

Exclusion Criteria

* Any signs of serious mental illness or cognitive deficit
* Current suicidal/homicidal ideations
* History of IPV with their main partner and safety concerns in the current relationship.

Primary outcomes:
measure: Drug use Frequency
timeFrame: 9 Months
measure: Urine assay for drug use
timeFrame: 9 Months
measure: CAS with casual partners
timeFrame: 9 Months
Secondary outcomes:
measure: Bacterial sexually transmitted infections
timeFrame: 9 Months
measure: Binge Drinking
timeFrame: 9 Months
measure: PrEP Uptake
timeFrame: 9 months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: New York
country: United States
facility: Hunter College
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: