louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02774161: B-mode Ultrasound Imaging in Detecting Early Liver Cancer
Official title: Quantitative Ultrasound Spectroscopy to Early HCC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis
Early Hepatocellular Carcinoma
Fibrosis
Stage I Hepatocellular Carcinoma
Stage II Hepatocellular Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 45
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: This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.

Detailed description: PRIMARY OBJECTIVES:

I. To investigate the use of quantitative ultrasound spectroscopy to detect early hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e. robust) method to confirm disease in developing countries.

OUTLINE:

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

Eligibility criteria: Inclusion Criteria:

For Healthy Volunteers

1. Patients over 18 years of age.
2. Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the ultrasound physicians will conduct the medical exam prior to any study procedures.

For HCC patients

1. Patients over 18 years of age.
2. Patient with confirmed diagnosis of HCC, and untreated or Patients with Suspected HCC (Suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6 cm in depth of the transducer head to minimize attenuation) and untreated or Patients at a higher risk of HCC undergoing a screening program by Ultrasound.

Exclusion Criteria:

For Healthy volunteers

1. Patients who are not likely to comply with the protocol requirements.

For HCC patients

1. Patients should not be taking other Investigational Agents.
2. Concomitant medications for treatment of the target lesion.

Primary outcomes:
measure: Mid-band fit
timeFrame: Up to 16 months
measure: Spectral intercept
timeFrame: Up to 16 months
measure: Spectral slope
timeFrame: Up to 16 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Aya Kamaya
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812561: Effects of Bronch™ on Respiratory Health
Official title: A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Bronch™ on Respiratory Health
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Health
Keywords: Respiratory Health
Korean mint
licorice
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of Bronch™(mixture of extraction of Korean mint and licorice) on respiratory health.

Detailed description: This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 60 subjects were randomly divided into Bronch™ group and a placebo group. It is to evaluate the changes in the displayed evaluation items when taking one pill twice a day, in comparison with taking a placebo.

Eligibility criteria: Inclusion Criteria:

* Age 19-80 years at screening
* nonsmoker
* After fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice

Exclusion Criteria:

* Participants with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders
* Participants who have Body Mass Index(BMI) less than 18.5 kg/m\^2 or more than 35 kg/m\^2
* Participants who have taken medication or dietary supplements related to the respiratory disease within 1 months prior to screening
* Participants with a history of antipsychotic medication use within 3 months prior to the screening examination
* Participants who alcoholic or drug abuse suspected
* Participants who have participated in the other human trials within 3 months before the screening test
* Laboratory test by show the following results

  * AST, ALT \> Reference range 3 times upper limit
  * Serum Creatinine \> 2.0 mg/dL
* Pregnancy or breast feeding
* Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Primary outcomes:
measure: Changes of CAT{Chronic obstructive pulmonary disease(COPD) Assessment Test} scores
timeFrame: screening, 6, 12 week
measure: Changes of BCSS(Breathlessness, Cough, and Sputum Scale) scores
timeFrame: 0, 6, 12 week
Secondary outcomes:
measure: FVC(Forced vital capacity)
timeFrame: screening, 12 week
measure: FEV1(Forced expiratory volume in 1 second)
timeFrame: screening, 12 week
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT03269461: Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Official title: Serial OCT Evaluation of Tissue Coverage in Patients Submitted to Inspiron Drug Eluting Stent Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: stent, DES, INSPIRON, OCT, tissue repair
Lead sponsor: Scitech Produtos Medicos Ltda
Sponsor class: INDUSTRY
First posted: 2017-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Prospective, multicentric, single-arm study to evaluate fast and effective tissue repair in patients undergone percutaneous coronary intervention with drug eluting stent Inspiron.

Detailed description: The first 20 patients enrolled will be evaluated by angiography and Optical Coherence Tomography 3 months after stent implantation. The following 20 patients will be evaluated by the same methods 2 months after the implantation and the last 20 patients after 30 days.

All patients will be clinically followed at 30 days, 6 months, 1 and 2 years after index procedure.

Eligibility criteria: Inclusion Criteria:

* Age ≥18 and ≤ 80years;
* Symptomatic CAD or documented myocardial ischemic disease;
* Up to 2 de novo lesions on native coronary arteries;
* Lesion length ≤ 29mm;
* Reference vessel diameter between ≥2.5 and ≤ 3.5 mm;
* Stenose at target lesion ≥ 70% and ≤ 99%.

Exclusion Criteria:

* STEMI within the last 72 hours pre-procedure;
* renal insufficiency;
* Left Main stenosis \> 50%;
* Ostial lesions;
* Bifurcation lesions with side branch ≥2mm;
* More than one lesion \> 50% at the target vessel;
* Left Ejection Fraction less than 30%;
* Previous (less than 6 months) PCI at the target vessel.

Primary outcomes:
measure: Tissue Coverage
timeFrame: 3 months
Secondary outcomes:
measure: in-stent late lumen loss
timeFrame: 3 months
measure: Stent Thrombosis
timeFrame: 2 years
measure: Target Vessel Failure
timeFrame: 2 years
Other outcomes:
Locations:
city: Vila Velha
country: Brazil
facility: Hospital Evangélico do Espírito Santo
state: Espírito Santo
city: Goiânia
country: Brazil
facility: Hospital do Coração Anis Rassi
state: Goiás
city: Maringá
country: Brazil
facility: Paraná Medical Research Center
state: Paraná
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
state: SP
Study officials:
References:
Clinical trial NCT03845361: Radial Artery Cannulation and Perfusion Index
Official title: Does Radial Artery Cannulation Affect the Perfusion of the Dominant Hand in Patients Undergoing Open Cardiac Surgery? Data Derived From the Peripheral Perfusion Index.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Perfusion
Keywords: Perfusion index
Cardiac Surgery
Radial artery cannulation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to investigate if radial artery cannulation of the dominant hand affects its peripheral perfusion during cardiac surgery using cardiopulmonary bypass.

Detailed description: Invasive blood pressure monitoring is mandatory in cardiac surgeries. Radial artery cannulation is the most common technique used for monitoring of invasive blood pressure and for arterial blood gas analysis.

Perfusion index derived from pulse oximetry is a new method for monitoring of peripheral perfusion.

this study aims to investigate if radial artery cannulation affects the intra-operative peripheral perfusion in the dominant cannulated hand

Eligibility criteria: Inclusion Criteria:

* Elective cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

* Peripheral vascular diseases
* previous upper limb surgeries
* planned radial artery harvesting

Primary outcomes:
measure: The perfusion index
timeFrame: Intraoperative
measure: The peripheral temperature
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
Clinical trial NCT05879861: Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer
Official title: Development and Validation of a Risk Prediction Model for Preoperative Frailty in Elderly Patients With Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 364
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the diagnostic criteria of colorectal cancer in Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer 2020 Edition and underwent surgery.

Brief summary: Fried Scale and its related scales were used to analyze the status and risk factors of preoperative frailty in elderly patients with colorectal cancer. R software was used to construct a risk prediction model for preoperative frailty in elderly patients with colorectal cancer, and its validity and stability were verified in clinical practice.


Eligibility criteria: Inclusion Criteria:

1. patients who met the diagnostic criteria of colorectal cancer in Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer 2020 Edition and underwent surgery;
2. patients aged ≥60 years old ;
3. patients who are clearly conscious, able to understand instructions, communicate normally, and complete the physical activity ability test without the assistance of others;
4. patients who gave informed consent and volunteered to participate in the study.

Exclusion Criteria:

1. patients with limb joint disease and lower limb pain;
2. patients with serious heart, liver, kidney diseases could not complete the test;
3. patients with visual impairment and hearing impairment;
4. patients with a history of mental illness or drug dependence;
5. taking antidepressants, levodopa/carbidopa, donepezil hydrochloride and other drugs ;
6. patients who received preoperative radiotherapy and chemotherapy;
7. Patients with hypothyroidism, Parkinson's disease, stroke and other diseases.

Primary outcomes:
measure: Status of frailty
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Yongmei Zhang
state: Guizhou
Study officials:
affiliation: Zunyi Medical College
name: Yongmei Zhang
role: STUDY_DIRECTOR
References:
Clinical trial NCT05107661: Colorectal Screening Strategies in Underserved Populations
Official title: Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Colorectal Cancer
Lead sponsor: Virtua Health, Inc.
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2021-11-04
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population is economically disadvantaged minority, medically underserved individuals that meet eligibility requirements for participation in the New Jersey Cancer Education Early Detection Program.

Brief summary: Research efforts are necessary to identify strategies to increase colorectal screening in underserved patient populations. Racial, ethnic minorities and medically underserved individuals continue to experience disparities in colorectal cancer mortality despite the availability of screening tests that can detect tumors early when treatments are most effective.

Detailed description: To determine the effectiveness of completion of colorectal cancer screening through fecal testing for blood and/or colonoscopies as a screening intervention utilizing digital reminders versus telephone prompts and reminders in economically disadvantaged minority communities as part of a colorectal screening outreach program.

Eligibility criteria: Inclusion Criteria:

* Any Gender
* 45-64 years of age
* Able to sign the informed consent form
* Meets eligibility criteria to participate in New Jersey Cancer Education Early Detection Community Outreach Program

  * Uninsured/underinsured
  * Household income \<250% Federal Poverty Level
  * Must be New Jersy resident
* Must have Smart phone
* Must speak English or Spanish

Exclusion Criteria:

* History of colon cancer, colon/rectal polyps and rectal bleeding
* Individuals with Dementia
* ECOG Performance Status 3-4
* Prior Colonoscopy within past 10 years

Primary outcomes:
measure: : Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
timeFrame: 3 month intervals
Secondary outcomes:
measure: Colorectal Screening Strategies in the High Risk Medically Underserved Population in a Hospital-based Community Outreach Program
timeFrame: 3 month intervals
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: Virtua Health
state: New Jersey
Study officials:
References:
Clinical trial NCT02901561: Comparison Between 2 Doses of Misoprostol Before Intrauterine Device
Official title: Comparison Between 2 Different Doses of Vaginal Misoprostol Before Intrauterine Device Insertion in Parous Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain Relief
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 212
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the investigators' study was to evaluate whether misoprostol will improve pain scores .

Detailed description: an intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the intrauterine device insertion tube, and removing the tube; and placement of the device in the uterus.

Eligibility criteria: Inclusion Criteria:

* • Women not taken analgesics or anxiolytics in the 24 hours prior insertion

  * Women who will accept to participate in the study

Exclusion Criteria:

* Any contraindication to IUD placement

Primary outcomes:
measure: Mean pain score during intrauterine device insertion
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT06485661: Effect of Captopril on GLS in Duchenne Myodystrophy
Official title: Intermediate Term Effect of Captopril on Left Ventricle Global Longitudinal Strain in Patients With Duchenne Myodystrophy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Effect of Drug
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD)

Detailed description: ACEI slowing down the onset and the progression of dystrophinopathic cardiomyopathy.

To outline the intermediate term effect of prescribing Captopril as an add on therapy on Left ventricular functions as measured by Global longitudinal strain in patients with Duchenne myodystrophy (DMD

Eligibility criteria: Inclusion Criteria:

* Genetically confirmed Duchenne myodystrophy (DMD) patients with abnormal GLS \< -18% with minimum age of 6 years old.

Exclusion Criteria:

* Any patient who refuses to sign an informed consent.
* Contraindication to ACEI: hypersensitivity - renal impairment - bilateral renal artery stenosis - aortic valve stenosis - hyperkalemia - hypotension.
* Reduced ejection fraction below 50%.

Primary outcomes:
measure: The impaired global longitudinal strain will change in echo in the number of participants with duchenne myodystrophy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
affiliation: Professor of cardiology -Ain Shams university
name: Mona Mostafa Rayan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02213783: Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia
Official title: Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia Following Administration by 4-hour Infusion and Bolus Injection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients With Febrile Neutropenia
Keywords: Imipenem
Febrile neutropenia
Gram-negative infection
Pharmacodynamic
Monte Carlo Simulation
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-08-11
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is prospective and randomized study to compare the pharmacodynamics (t\>MIC) of 0.5 g every 6 h of imipenem in twelve patients with febrile neutropenia following administration by a 4 h infusion or bolus injection.

Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte Carlo technique (Computer model) to get PK/PD index (40%T\>MIC) and reported to %PTA (Probability Target Attainment) and %CFR (Cumulative Faction Response.


Eligibility criteria: Inclusion Criteria:

* Patients aged \> or = 20 years
* Patients who have febrile neutropenia with Gram negative bacilli infections which are sensitive to imipenem by the disk diffusion
* Patients who are likely to survive 3 days

Exclusion Criteria:

* Patients who have documented hypersensitivity to imipenem or other carbapenems
* Patients who have an estimated creatinine clearance of \< 50 ml/min
* Patients who are in circulatory shock or hypotension (systolic \< 90 mmHg)
* Patients who are pregnant

Primary outcomes:
measure: Concentration of imipenem in plasma
timeFrame: 6 hours profile after 8th dose of imipenem
Secondary outcomes:
Other outcomes:
Locations:
city: Hat Yai
country: Thailand
facility: Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University
state: Songkla
Study officials:
affiliation: Prince of Songkla University
name: Sutep Jaruratanasirikul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01432483: Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)
Official title: Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Cancer
Keywords: Cancer
ONTAK
Denileukin diftitox
persistent or recurrent disease
requiring continued delivery of essential cancer therapy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to patients who are currently on therapy and who have no other suitable treatment options, where therapy is requested by their physician.

Detailed description: The Access Program will be provided as long as appropriate according to the judgment of the provider. If Denileukin diftitox (ONTAK) becomes commercially available without restriction, then the access program will be discontinued.

Eligibility criteria: Inclusion Criteria:

To receive denileukin diftitox (ONTAK) under this protocol, the patient's physician must request this therapy for the specific patient. Patients may continue treatment with denileukin diftitox if they:

* Are currently on therapy with denileukin diftitox and require ongoing therapy to maintain control of their disease.
* Are willing and able to comply with all aspects of the Access Protocol
* Provide written informed consent to participate

Exclusion Criteria:

Patients are not eligible for the Access Program with denileukin diftitox if they:

• Are not currently on denileukin diftitox therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Eisai Inc.
name: Gary Palmer, MD
role: STUDY_DIRECTOR
References: