louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05948904: Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.
Official title: Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic and Treatment of Pulmonary Lesions: An Ex-Vivo Human Lung Model Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
Keywords: Lung
cryobiopsy
cryoablation
transbronchial intervention
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 200
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: Developing a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.

Detailed description: Surgical lung biopsy (SLB) and surgical resection are the current gold standard for both tissue sampling and ablation of pulmonary lesions. Albeit the use of minimally invasive surgical techniques (VATS), these interventions are frequently associated with complications which include: prolonged air leak, pneumonia, prolonged length of stay in the intensive care unit as well as an increased mortality rate which is influenced by the nature (elective vs non-elective) of the case. To reduce trauma to patients, transbronchial interventions are becoming increasingly popular. However, current techniques have only been demonstrated in humans for lung biopsy and often provide lesser quality specimens than SLB. Promising results have been achieved using cryotechnology but a standardized technique has yet to be established.

To demonstrate the potential for transbronchial interventions using cryo, we aim to develop a standardized technique for transbronchial cryobiopsy and cryoablation of pulmonary lesions using a human ex-vivo model.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lung transplant surgery

Exclusion Criteria:

* Organ donor ineligible to donate lungs
* Healthy individuals

Primary outcomes:
measure: Measure of Pleural breakage (Absent or Present)
timeFrame: 48 months
measure: Temperature of ice ball at center; Temperature of ice ball at periphery; Temperature of ice ball at varying distances from ice ball
timeFrame: 48 months
measure: Model of cryogen
timeFrame: 48 months
measure: Freezing Time
timeFrame: 48 months
measure: Size of resected specimen
timeFrame: 48 months
Secondary outcomes:
measure: Blood loss and complication
timeFrame: 48 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: CHUM
state: Quebec
Study officials:
References:
Clinical trial NCT00386204: Side Effects of Q-Switched Ruby Laser for the Treatment of Lentigines in Light and Dark Skin Types
Official title: Efficacy and Side Effects of Q-Switched Ruby Laser Treatment of Solar Lentigines in Two Different Fitzpatrick Skin Types II and IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solar Lentigines
Keywords: Q-switched Ruby laser
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-10-11
Enrollment: 90
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is a comparison of efficacy and side effects of Q-switched Ruby laser treatment for solar lentigines in two different skin types II and IV.

Detailed description: It has been widely accepted that dark colored individuals are prone to develop laser induced side effects especially post inflammatory hyperpigmentation(PIH) and it could be a limiting issue in selecting dark colored individuals.

We designed this study to evaluate the difference of efficacy and side effects in light and dark skinned individuals.

Eligibility criteria: Inclusion Criteria:

* Solar Lentigines
* Fitzpatrick skin type II and IV

Exclusion Criteria:

* Pregnancy
* Age above 80
* Photosensitivity
* Concern for malignancy
* Active Infection

Primary outcomes:
measure: Clinical Clearance
measure: Side Effects
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Skin Research Center, Shohada-e Tajrish Hospital, Shaheed Beheshti Medical University
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Parviz Toossi, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05659004: Referrals for CLTI: Qualitative Study
Official title: The Experiences of Patients With Chronic Limb-threatening Ischaemia From First Symptom to Vascular Surgery Assessment: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Limb Threatening Ischemia
Lead sponsor: University of Hull
Sponsor class: OTHER
Collaborators: name: The Royal College of Surgeons of England
First posted: 2022-12-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with chronic limb-threatening ischaemia in the last year

Brief summary: The goal of this qualitative study is to explore the experiences of patients who have been diagnosed with chronic limb-threatening ischaemia (CLTI). The main questions it aims to answer are:

* What are the perceptions and experiences of patients between first symptom of CLTI and vascular surgery assessment
* What is important to patients during this process.

Participants will be interviewed and their words analysed using reflexive thematic analysis.

Detailed description: There are delays at every stage of the patient journey from developing chronic limb-threatening ischaemia (CLTI) to treatment, associated with poorer outcomes for patients. There is currently limited national and international guidance on how and when to refer patients with suspected CLTI to specialist vascular surgery services. The use of qualitative interviews will allow us explore perceptions and experiences of patients with CLTI being referred to vascular surgery services, and identify possible ways to improve the process via interviews. This study will provide novel information on patient experience, and together with other work provide a framework for improvement of the referral process for CLTI.

Eligibility criteria: Inclusion Criteria:

- CLTI diagnosed in the last year

Exclusion Criteria:

* Lacking capacity to consent to interview
* Potential to be violent
* Cognitive impairment
* Non-English speaking

Primary outcomes:
measure: Experiences and perceptions of patients on their journey to diagnosis of CLTI
timeFrame: To be conducted in 2023
Secondary outcomes:
measure: Potential improvements the process from first symptom to diagnosis of CLTI
timeFrame: To be conducted in 2023
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust
state: Cambd
city: Wakefield
country: United Kingdom
facility: Mid Yorkshire Hospitals NHS Trust
state: Yorkshire
Study officials:
affiliation: University of Hull
name: Ian Chetter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04554004: A Non-invasive Index of Microciculatory Resistance
Official title: A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Microvascular Disease
Coronary Artery Disease
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 295
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: Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.


Eligibility criteria: Inclusion Criteria:

* Subject must be older than 18 years
* Written informed consent available
* Subject is indicated for invasive coronary angiography
* Subject need to be taken within 30 days after enrolment

Exclusion Criteria:

* Previous PCI or CABG
* Subject is not eligible for measuring IMR
* Complicated complex congenital heart disease
* Artificial pacemaker or internal defibrillator leads implanted
* Implanted artificial heart valve
* Severe arrhythmia including complete AV block, ventricular arrhythmia
* Impaired chronic renal function (serum creatinine\>1.5ULN)
* Allergic to iodine
* Pregnancy
* Body mass index \>35 kg/m2
* Left ventricle is markedly thickened
* Needs for emergency procedures
* Severe distortion of in the blood vessel
* Unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic \< 90mmHg), severe congestive heart failure or pulmonary edema
* Life-threatening diseases (life expectancy \< 2 months)
* Tako Tsubo syndrome (TTS)
* Others who are inappropriate subject judged by clinician

Primary outcomes:
measure: sensitivity and specificity
timeFrame: up to 12 months
Secondary outcomes:
measure: diagnostic
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: First People's Hospital of Hangzhou
state: Zhejiang
Study officials:
References:
Clinical trial NCT04420104: Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
Official title: Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Erector Spinae Plane Block
Cardiac Surgery
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.

Eligibility criteria: Inclusion Criteria:

* Must be ASA score I-III
* Must be 18-75 years old
* must undergo cardiac surgery

Exclusion Criteria:

* emergency surgery,
* bleeding diathesis,
* presence of contraindications to LA agents used in this study,
* use of chronic opioids,
* psychiatric disorders.
* prolonged extubation
* presence of infection at the injection site.
* cardiovascular conditions (EF\<40, LMCA obstruction)

Primary outcomes:
measure: change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.
timeFrame: baseline and hours 3-6-12-24-36-48
measure: time to mobilize the patient
timeFrame: Any time for 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Study officials:
affiliation: Adnan Menderes University Medical Faculty Hospital
name: Sinem Sari, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
citation: Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.
Clinical trial NCT01869504: A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
Official title: A Feasibility and Safety Study of the Use of a Dedicated Ballooned Intercostal Drain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pleural Effusion
Keywords: Ballooned intercostal drain
Pleural effusion
Lead sponsor: Sherwood Forest Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 19
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Drainage of air and fluid from the chest cavity using plastic tubes (chest drains) is an essential tool in Chest Medicine. A common complication of drain insertion is accidental removal of the drain, usually as a result of inadequate securing techniques, with rates of up to 1 in 5 reported. This often results in the need for further procedures (including drain re-siting), with associated additional risk to the patient and an increase in health care costs. One suggested method to reduce premature drain removal is to use chest drains with ballooned tips, much like a bladder catheter. These would provide a physical obstruction inside the chest cavity at the insertion site, whilst being easy to use as stitching or extensive taping may not be required.

The investigators propose a trial of a dedicated ballooned chest drain to investigate whether a reduction in drain re-siting rates can be achieved. Pain scores will also be assessed during this trial to ensure that irritation of the lining of the lung or chest wall by the balloon is not excessive.


Eligibility criteria: Inclusion Criteria:

* Age \>16 years
* Able to give written informed consent
* Requiring intercostal tube drainage of a pleural effusion for clinical reasons

Exclusion Criteria:

* Requiring intercostal tube drainage for chest trauma
* Requiring blunt dissection for drain insertion

Primary outcomes:
measure: The percentage of intercostal drains requiring re-siting
timeFrame: 7 days
Secondary outcomes:
measure: Patient reported pain scores, using a visual analogue scale
timeFrame: At 24 hours, 72 hours, and at drain removal, an expected average of 5 days
measure: The frequency of balloon rupture
timeFrame: 7 days
Other outcomes:
Locations:
city: Sutton-in-Ashfield
country: United Kingdom
facility: King's Mill Hospital
state: Nottinghamshire
Study officials:
affiliation: Sherwood Forest Hospitals NHS Foundation Trust
name: Samuel V Kemp, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06897904: Basic Hematological Parameters and Coagulation Profile in Type 1 Diabetic Children
Official title: Basic Hematological Parameters and Coagulation Profile in Type 1 Diabetic Children
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 110
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: type 1 diabetic children and matched healthy controls.

Brief summary: Diabetes mellitus is a group of chronic metabolic diseases characterized by hyperglycemia .Type 1 diabetes is a heterogeneous disease related to the destruction of pancreatic beta cells and is a result of absolute lack of insulin

* Diabetes mellitus has been traditionally looked upon as a disease of adults (except Type I diabetes), however it can affect individuals of any age. Given the peculiarities and problems that it carries, diabetes in children and adolescents poses special challenges to the entire society. Diabetes is the second commonest chronic disease occurring in 1 in every 1500 children by age 5 and in 1 in 350 children by age 8 . Microvascular (retinopathy, neuropathy, and nephropathy) Aim of the research to assess basic hematological parameters and coagulation profiles among type 1 diabetic children and compare them with healthy controls and macrovascular (coronary artery disease, peripheral vascular disease, and cerebrovascular disease) atherothrombotic complications may occur in children and adolescents, depending on the duration of diabetes, the degree of metabolic control, and other factorssuch as genetics . Diabetes mellitus can cause blood disorders such as deformity of red blood cells and increase their adhesion \[6\].It has an effect on the function of red blood cells through the interaction with the membrane and intracellular components . Red blood cell distribution width (RDW) is a measure of the difference in the size of red blood cells. An increase in RDW can be caused by anemia or nutritional deficiencies related to anemia
* Studies have shown that the average number of red blood cells, hemoglobin and hematocrit in diabetic patients is lower than the control group, which indicates the presence of anemia in diabetic patients .


Eligibility criteria: Inclusion Criteria:

* Age from one month to 18 year.
* Both sexes.
* Patients known to have type 1 diabetes.

Exclusion Criteria:

* Patients less than one month and more than 18years.
* history of bleeding disorders or anemia unrelated to diabetes.
* Otherc types of diabetes .

Primary outcomes:
measure: Prothrombin time
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02936804: Precision Diagnosis and Therapy for Early Stage Lung Cancer
Official title: Key Technology in Precision Diagnosis and Therapy for Early Stage Lung Cancer: a Single Arm Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: early stage lung cancer
LDCT screening
lung resection
electromagnetic navigation bronchoscopy
peripheral biomarker
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 60000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The present study is a single arm clinical trial aiming to improve the key technology in the diagnosis and treatment of early stage lung cancer. 60,000 high-risk subjects (age 45-70) are planned to recruit and assign to the Low Dose Computed Tomography (LDCT) screening arm (Baseline + 2 rounds of biennial repeated LDCT screening). Management of positive screening test will be carried out by a pre-specified protocol.


Eligibility criteria: Inclusion Criteria:

• Eligible participants were those aged 45-70 years, and with either of the following risk factors:

1. history of cigarette smoking ≥ 20 pack-years, and, if former smokers, had quit within the previous 15 years;
2. malignant tumors history in immediate family members;
3. personal cancer history;
4. professional exposure to carcinogens;
5. long term exposure to second-hand smoke;
6. long term exposure to cooking oil fumes.

Exclusion Criteria:

1. Had a CT scan of chest within last 12 months
2. History of any cancer within 5 years

Primary outcomes:
measure: Lung cancer incidence rate
timeFrame: 5 years
Secondary outcomes:
measure: Lung cancer disease free survival
timeFrame: 5 years
measure: Lung cancer mortality
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Chest hospital
state: Shanghai
Study officials:
affiliation: Shanghai Chest Hospital
name: Baohui Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00716404: Post-Market Observational Study of Intra-Renal Drug Delivery
Official title: Post-Market Observational Study of Intra-Renal Drug Delivery
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Targeted Renal Therapy
Keywords: FlowMedica
Benephit
TRT
Patients
Components
Benephit Infusion System
Planned
To be used
Lead sponsor: FlowMedica, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized patients in whom one or more components of the Benephit Infusion System are planned to be used.

Brief summary: This is a prospective, observational, multi-center study with consecutive enrollment. Up to 1,000 patients will be enrolled. The objective of this post-marketing surveillance study is to collect clinical usage patterns of the Benephit Infusion Systems. As a result, FlowMedica will be able to:

1. Better understand and quantify usage patterns including patient characteristics, adjunctive procedures, and infusion agents.
2. Collect user-interface information and overall customer satisfaction.
3. Monitor post-marketing device performance.


Eligibility criteria: Inclusion Criteria:

* Exposure to one or more components of the Benephit Infusion System
* Ability to give written informed consent

Exclusion Criteria:

* Inclusion in another clinical study that may affect usage of the Benephit system

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Owensboro
country: United States
facility: Owensboro Heart & Vascular
state: Kentucky
city: Lafayette
country: United States
facility: Cardiovascular Institute of the South
state: Louisiana
city: Portland
country: United States
facility: Providence Heart & Vascular
state: Oregon
Study officials:
affiliation: Southeast Renal Associates
name: James A Tumlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiovascular Institute of the South
name: David E Allie, MD
role: PRINCIPAL_INVESTIGATOR
References: