louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05602636: Analgesic Effect of Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA in Forearm Surgery
Official title: Efficacy of Combined US-Guided Supraclavicular Block and Interscalene Analgesia Versus an Intercostobrachial Nerve Block Versus PCA With Fentanyl on Preventing Tourniquet Pain in Forearm Surgery: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Forearm Surgery
US-Guided Supraclavicular Block
Interscalene Analgesia
Tourniquet Pain
Keywords: Intercostobrachial Nerve Block
PCA with Fentanyl
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The etiology of tourniquet pain is complex, and the study team hypothesizes that blocking with Interscalene brachial plexus block (ISBPB) is more efficient in decreasing the incidence of tourniquet pain in comparison with other techniques.

As there is a paucity of studies that evaluate the effect of intercostobrachial nerve (ICBN) block and ISBPB and Patient-Controlled Analgesia (PCA) with a supraclavicular brachial plexus block (SCBPB) on tourniquet pain in forearm surgery, Therefore, we established this randomized study to compare ISBPB and ICBN and PCA with fentanyl with SCBPB in terms of the incidence and severity of tourniquet pain in patients undergoing forearm surgery.


Eligibility criteria: Inclusion Criteria:

* aged more than 18 years,
* ASAI-III patients
* scheduled to undergo orthopedic or plastic surgery distal to the elbow with an anticipated tourniquet duration greater than 45 min.
* desiring regional anesthesia as the primary anesthetic.

Exclusion Criteria:

* Contraindication to regional anesthesia.
* Allergy to local anesthetics.
* Primary block failure.
* If patients desired deep intraoperative sedation.
* Clinically significant cognitive impairment.

Primary outcomes:
measure: The incidence of tourniquet pain
timeFrame: 2 hours
Secondary outcomes:
measure: Hemodynamics
timeFrame: 2 hours
measure: The incidence of adverse reactions
timeFrame: 2 hours
measure: Patients' satisfaction
timeFrame: 24 hours
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Facualty of Medicine(Damietta), Al Azhar University
Study officials:
References:
Clinical trial NCT04688736: Efficacy of Placebo Versus Chlorpheniramine for the Prevention of Allergic Transfusion Reactions.
Official title: A Prospective, Randomized, Double-blind Controlled Trial of Chlorpheniramine Pretransfusion Medication for Allergic Transfusion Reactions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Allergic Transfusion Reaction
Keywords: pretransfusion medication
Chlorpheniramine
blood transfusion
allergic transfusion reaction
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 6642
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective, randomized, double-blind controlled trial to evaluate the efficacy of placebo versus chlorpheniramine for the prevention of allergic transfusion reactions.


Eligibility criteria: Inclusion Criteria:

* 18\~65 years old.
* Subject is diagnosed with hematological disorder and requires blood product (i.e. suspended red blood cells, apheresis platelets, fresh frozen plasma) transfusions.
* Subject can fully understand and voluntarily sign informed consent forms.

Exclusion Criteria:

* Subject with a history of allergic diseases.
* Subject experienced at least 1 moderate/severe or 2 mild allergic reactions in the past.
* Subject received glucocorticoid or allergy drugs within 24 hours before blood transfusion.
* Subject transfused with washed RBC.
* Received allo-HSCT transplantation before.
* Subject with heart failure.
* Subject suffered from sequelae of cardiovascular or cerebrovascular diseases.
* Pregnant or nursing women.
* Inability to understand or to follow study procedures.

Primary outcomes:
measure: The rate of allergic-transfusion reactions
timeFrame: within 4 hours from the start of the transfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Zhoukou
country: China
facility: Zhoukou Central Hospital
state: Henan
city: Tai'an
country: China
facility: The Second Affilated Hospital of Shandong First Medical University
state: Shandong
city: Tianjin
country: China
facility: Regenerative Medicine Center
state: Tianjin
Study officials:
References:
Clinical trial NCT05410236: 3D Printing in Airway Anatomy and Bronchoscopy Education
Official title: The Application of Three-dimensional Printing in Airway Anatomy and Bronchoscopy Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satisfaction, Personal
Lead sponsor: Fu Jen Catholic University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The main purpose of this study is to use 3D printing technology to make a human anatomical bronchial tree model, which is applied in medical education for medical students and students of the department of respiratory therapy. Most of the clinical teaching material is expansive and inaccessible. To promote accessibility of anatomy models and student learning effects in our school and hospital, we use the 3D printing technology to print bronchial tree model and apply it to anatomy and bronchoscopy education.

The present study expects some benefits that the use of printed bronchial trees for anatomy and bronchoscopy education. For example, it can reduce the cost of anatomy instruction, let students have their own anatomical model, and make the learning no longer limited to the anatomical classroom.

Detailed description: Three-dimensional (3D) printing is a technology used for the rapid production of customized physical objects. Bronchoscopy is a well-established, relatively safe procedure for both diagnostic and therapeutic interventions for a variety of pulmonary diseases. In this study, to enhance the quality of airway anatomy education and bronchoscopy training, we used 3D printing to develop a 3D bronchial tree model as a high-fidelity simulator for bronchoscopy and demonstrated its validity. We designed a 3D bronchial tree model containing 12 detachable parts and 11 adapter rings.

Eligibility criteria: Inclusion Criteria:

* Student of Fu Jen Catholic University.

Exclusion Criteria:

* Refused to participate in the study.

Primary outcomes:
measure: Examination score of pre-intervention
timeFrame: pre-intervention
measure: Examination score of post-intervention
timeFrame: immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Fu Jen Catholic University Hospital, Fu Jen Catholic University
Study officials:
affiliation: Fu Jen Catholic University Hospital
name: Ke-Yun Chao, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01040936: Intensive Lipid Lowering Treatment in Non-ST-elevation Acute Coronary Syndrome (NSTE-ACS) Patients
Official title: Intensive Lipid Lowering Treatment in Patients With Non-ST-elevation ACS Undergoing Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: acute coronary syndrome
intervention
outcome
patients diagnosed ad Non-ST elevation ACS
patients received PCI therapy
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2009-12-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.


Eligibility criteria: Inclusion Criteria:

* finish informed consent
* age≥18y and under 75y
* diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
* willing to receive the coronary angiography and potential PCI therapy

Exclusion Criteria:

* patient was treated by statins before randomization
* stable angina or ST elevation myocardial infarction
* without informed consent
* abnormal liver function before randomization, (AST，ALT≥3ULN)
* active hepatitis or muscular disease
* impaired renal function with serum creatinine level \> 3mg/dl
* impaired left ventricular systolic function with LVEF\< 30%
* participating in other studies
* non-PCI treated patients after coronary angiography will be washed out

Primary outcomes:
measure: The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization.
timeFrame: one year
Secondary outcomes:
measure: rate of peri-procedural myocardial infarction
timeFrame: 30days
measure: MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization
timeFrame: 30 days
measure: changes of left ventricular function at 30d after randomization
timeFrame: 30 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Dept. of Cardiology
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Wei Feng Shen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05289336: DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
Official title: DAHANCA 27 Transoral Laser Microsurgery for T1a Glottic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Glottic T1
Keywords: Transoral laser microsurgery
Accelerated radiotherapy
Lead sponsor: Danish Head and Neck Cancer Group
Sponsor class: NETWORK
First posted: 2022-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Phase 2 prospective non-inferiority trial comparing with previous prospective collected national cohort
Primary purpose: TREATMENT

Brief summary: To evaluate whether Transoral Laser Microsurgery (TLM) is non-inferior compared to Accelerated Radiotherapy (accRT) in the treatment of T1aN0M0 glottic SCC

Detailed description: Since 2003 the Danish national standard treatment for T1aN0M0 glottic SCC has been accelerated RT (66Gy. 2 GY/fraction, 6 fractions/week). In 2012 cordectomy type I-III using TLM was introduced as an experimental treatment.

The DAHANCA 27 trial is a comparative non-inferiority phase II study comparing two timely separated national patient cohorts. Patients treated with radical TLM from September 2012 to April 2016 were included in the TLM cohort, and patients treated with accelerated RT from January 2003 to august 2012 were included in the RT cohort

Eligibility criteria: Inclusion Criteria:

* Danish patients aged ≥18 years diagnosed with a T1aN0M0 glottic squamous cell carcinoma (SCC)

Exclusion Criteria:

* Unable to complete curative intended protocol treatment and/or planned follow up
* informed concent

Primary outcomes:
measure: laryncegtomy free survival
timeFrame: 5 years
Secondary outcomes:
measure: Local control
timeFrame: 5 years
measure: Ultimate tumor control
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Voice quality
timeFrame: 3 years
measure: Radiation free survival
timeFrame: 5 years
measure: any other treatment related morbidity
timeFrame: 5 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Experimental Clinical Oncology, Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aalborg University Hospital, Denmark
name: Nina M Lyhne, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06698536: OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff
Official title: OBPM_COYOTE2024 Physiological Data Recording With the Calibration-free Optical Aktiia G2C Device at Fingertip and Wrist, Alongside the Aktiia Oscillometric Cuff: a Single-center, Prospective Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: hypertension
blood pressure
Lead sponsor: Aktiia SA
Sponsor class: INDUSTRY
First posted: 2024-11-21
Enrollment: 255
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study subjects are asked to stay seated while 3 successive measurements are taken with the device under investigation (BP and PR) and two references (Aktiia Bracelet G2 and Aktiia Init I1 oscillometric cuff).
Primary purpose: OTHER

Brief summary: The present study, OBPM_COYOTE2024, with N = 255 participants minimum over 1 visit (lasting \~15min), has been designed to collect raw optical data with Aktiia.product-G2C Clinical investigational device together with Aktiia G2 Bracelet and Aktiia Init I1 oscillometric cuff within a cohort of subjects characterized by a wide variety of phenotypes. The resulting dataset will support research and development activities conducted by AKTIIA SA out of the study context.


Eligibility criteria: Inclusion Criteria:

* Subjects aged 21 to 85yo
* Subjects or witnesses fluent in written and spoken French
* Subjects agreeing to attend the study visit and follow study procedures
* Subjects that have signed the informed consent form.

Exclusion Criteria:

* Amputated index fingers
* Damaged/injured skin at index fingers
* Damaged/injured skin at wrists
* Subjects with tachycardia (heart rate at rest \> 120bpm)
* Subjects with atrial fibrillation
* Subjects with diabetes
* Subjects with marked renal dysfunctions (eGFR \< 30mL/min/1.73 m2)
* Subjects with untreated hyper-/hypothyroidism
* Subjects with pheochromocytoma
* Subjects with Raynaud's disease
* Subjects with an arteriovenous fistula
* Women in known pregnancy
* History of polyneuropathy

Primary outcomes:
measure: Data set build
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV Service de Néphrologie et d'Hypertension
Study officials:
References:
Clinical trial NCT02279836: Single Arm Post-marketing Study of SC20 Colonoscope
Official title: Open Label, Multi-center, Single Arm Post-marketing Study of SC20 Colonoscope and Colonoscopy System for Colonoscopy in Male and Female Patients >18 Years Old
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gentle Colonoscopy
Keywords: Patients with any indication for colonoscopy in the U.S.A.
Lead sponsor: Invendo Medical GmbH
Sponsor class: INDUSTRY
First posted: 2014-10-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The objective of the study is to gather post-market data regarding the performance of the invendo SC20 colonoscope in a real-world US population.

Detailed description: The objective of the study is to expand data collection and product exposure in a controlled clinical setting and gather data regarding the performance of the Invendo SC20 colonoscope in a real-world US population. The objective of the study is to specifically monitor three points:

1. The diagnostic performance of the device including polyp and adenoma detection rates;
2. The therapeutic performance of the device (the ability of the physician to remove/biopsy identified lesions);
3. Performance of the device in a typical colonoscopy population, including patients with underlying inflammatory bowel disease (IBD), previous pelvic surgery or irradiation, obesity, diverticular disease, and previous colorectal surgery, as they present in the study population (see below C.).

Eligibility criteria: Inclusion Criteria:

* Any indication for colonoscopy
* Willing to give informed consent
* Willing to consume 2-4 liters of bowel prep

Exclusion Criteria:

* An age younger than 18 years
* Congestive heart failure
* Renal insufficiency
* Intestinal obstruction
* Any acute life-threatening condition (in the opinion of the investigator)
* Current pregnancy
* Abdominal surgery in the past 6 months
* Bleeding disorders
* Inability to provide informed consent
* Any other contraindication to colonoscopy (e.g. fulminant colitis or acute diverticulitis)

Primary outcomes:
measure: 1. Cecal intubation rates (visualization of the cecum by notation of landmarks and photo documentation of landmarks in every procedure)
timeFrame: average 6 to 12 months
Secondary outcomes:
measure: 2. Detection of polyps, adenomas and other lesions in all individuals
timeFrame: average 6 to 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center Ambulatory care
state: New York
city: New York
country: United States
facility: New York Presbyterian Columbia University Medical Center
state: New York
Study officials:
affiliation: NYU Langone Medical Center
name: Adam Goodman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02234336: Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
Official title: Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Keywords: Echocardiography
hypertrophic cardiomyopathy
cardiomyopathy
magnetic resonance imaging
contrast
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: GE Healthcare
First posted: 2014-09-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with hypertrophic cardiomyopathy (HCM)

Brief summary: Assessment of wall thickness in hypertrophic cardiomyopathy (HCM) is of diagnostic and prognostic importance given its known association with sudden cardiac death. However, data regarding comparison of imaging modalities for this key measurement is lacking. This study seeks to compare assessment of maximum wall thickness between clinically indicated echocardiography (with and without contrast) and clinically indicated cardiac magnetic resonance imaging.

Detailed description: Patients receiving clinically indicated echocardiograms and cardiac magnetic resonance imaging at Mayo Clinic will be eligible.

Eligibility criteria: Inclusion Criteria:

1. Clinically and echocardiographically defined hypertrophic cardiomyopathy.
2. Clinically indicated transthoracic echocardiography as part of the medical evaluation.
3. No contradiction to administration of ultrasonic echocardiography contrast.
4. Planned clinically indicated cardiac magnetic resonance imaging as part of medical evaluation.
5. No contraindication to cardiac magnetic resonance imaging (such as cochlear implants, central nervous system aneurysm clips and other implanted medical devices).
6. Age 18 years and older

Exclusion Criteria:

1) Insufficient image quality for determination of maximal wall thickness.

Primary outcomes:
measure: Left Ventricular Wall Thickness
timeFrame: approximately 1 week after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Patricia Pellikka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03068936: IMRT Plus Cisplatin Versus IMRT in Patients With Stage 2 Nasopharyngeal Carcinoma
Official title: Intensity Modulated Radiotherapy Plus Cisplatin Versus Intensity Modulated Radiotherapy in Patients With Stage 2 Nasopharyngeal Carcinoma: A Phase 3 Multicenter, Open-label, Randomized, Non-inferior Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Intensity modulated radiotherapy
Cisplatin
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 716
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Nasopharyngeal carcinoma has high incidence in the southern China, especially in Guangdong Province. In the world, the standardized morbidity has reached 30/10 million in men while in women, about 13/10 million. At present, the incidence of nasopharyngeal carcinoma in China accounted for more than 80% of the world. The cancer-related deaths is in the eighth, which is a serious threat to our people's health and life. A recent multi-center phase II study of stage II nasopharyngeal carcinoma showed that: compared with Intensity Modulation Radiotherapy (IMRT) plus cisplatin, the 3 year local control rate, regional control rate, distant metastasis-free survival rate and disease-specific survival rate of IMRT were similar, but the side effects of radiotherapy alone group were lower.

Based on the results of the phase II clinical study, the investigators designed this phase III clinical study, with the aim to compared the efficacy and toxicity of these two treatment programs. And finally to provide sufficient evidence for the treatment of stage II nasopharyngeal carcinoma.


Eligibility criteria: Inclusion Criteria:

* The sex of the subject is not limited, the age is from 18 to 70 years old;
* Histologically proven nasopharyngeal squamous cell carcinoma, World Health Organization (WHO) II-III type;
* Union Internationale Contre le Cancer(UICC) stage 9 clinical stage II patients；
* Karnofsky score ≥ 80 points;
* No evidence of distant metastasis;
* Having an nasopharyngeal MRI before treatment ,which can measure the size of the tumor in order to analyze the effect.

Exclusion Criteria:

* The subject had previously suffered from other malignancies (except non-melanotic skin cancer or cervical carcinoma in situ);
* Previously received immunotherapy;
* Previously received chemotherapy;
* Previously received radiation therapy;
* Patients who had previously undergone surgical treatment for head and neck tumors (excluding cervical lymphadenectomy);
* Evidence of distant metastases or other malignancies at the same time.

Primary outcomes:
measure: Overall survival rate
timeFrame: up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: