louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05524207: Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque
Official title: A Controlled Clinical Study of Carotid Artery Stent Implantation in the Treatment of Vulnerable Plaque
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Artery Plaque
Carotid Stenosis
Stent Embolisation
Keywords: carotid artery stenosis
vulnerable plague
carotid stenting
Lead sponsor: Beijing Tsinghua Chang Gung Hospital
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients suffering from carotid artery stenosis

Brief summary: To investigate the efficacy and safety of carotid stenting for vulnerable carotid plaques. All patients with carotid artery stenosis underwent carotid arterial contrast-enhanced ultrasonography before operation. According to the examination results, they were divided into two groups: vulnerable plaque group and stable plaque group. The incidence of perioperative stroke events in the two groups was compared. The incidence of stroke events in the two groups within 1 year was compared.

Detailed description: 1. To enroll 100 cases of patients suffering from carotid artery stenosis。the investigators perform contrast enhanced ultrasound on patients for identifying the vulnerable plagues
2. The investigators divide patients into the stable group and the vulnerable group based on the results of CEUS inspection.
3. All patients undergo carotid stent. To analysis the incidence of postoperative complications such as stroke and mortality within 30 days and to compare the differences between the two groups.

Eligibility criteria: Inclusion Criteria:

* The patients with ischemic symptom whose carotid stenosis were more than 50%
* The patients without ischemic symptom whose carotid stenosis were more than 70%

Exclusion Criteria:

* • Confirmed with severe intracranial vascular lesions

  * Suffering from the large area cerebral infarction or critical stroke sequela
  * Restenosis after CEA or CAS
  * Suffering from severe coronary heart disease, respiratory failure,the hypertension difficult to controled
  * Patients with malignant tumor or expected life \< 2 years

Primary outcomes:
measure: Perioperative 30-day stroke rate
timeFrame: 30 days
Secondary outcomes:
measure: 1-year stroke rate after surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Chang Gung Hospital
Study officials:
affiliation: Beijing Tsinghua Chang Gung Hospital
name: sifan yang
role: STUDY_DIRECTOR
References:
Clinical trial NCT03678207: The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients
Official title: The Effectiveness of a Preoperative Blood Pressure Screening Program to Identify Undiagnosed Hypertension in Ambulatory Surgery Patients
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Perioperative Hypertension
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving elective ambulatory surgery with a preoperative blood pressure measurement greater than 160 (systolic) and/or 90 (diastolic)

Brief summary: Elevated blood pressure is the largest contributing risk factor to all-cause and cardiovascular mortality. According to the U.S. Preventive Services Task Force, hypertension affects nearly 30% of the adult population. Many patients remain undiagnosed, despite the consensus that screening and timely diagnosis is paramount. In this study, 108 ambulatory surgery patients with elevated blood pressure (160/90) that are not yet formally diagnosed with hypertension will be enrolled and alerted of their high blood pressure by a co-investigator MD. They will request permission to follow-up with the patient and the patient's primary care provider 6 months after the initial phone call to check in on the status of their diagnosis and any action taken (lifestyle changes, medication) to alleviate their high blood pressure. Patients will receive a follow-up letter/email at 6 and 3 months to remind them of their potential diagnosis.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective ambulatory surgery
* Patients with a pre-operative elevated BP defined as greater than 160/90
* Patients above the age of 18
* English speaking

Exclusion Criteria:

* Patients with a pre-existing diagnosis of HTN
* Patients who are taking a hypertensive medication
* Patients who had a pre-operative surgical screening assessment

Primary outcomes:
measure: Diagnosis of hypertension 6 months after surgery
timeFrame: 6 months postoperative
Secondary outcomes:
measure: PCP follow up 6 months after surgery
timeFrame: 6 months postoperative
measure: Hypertension treatment 6 months after surgery
timeFrame: 6 months postoperative
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
References:
Clinical trial NCT01366807: Screening of Nutritional Status in Cardiac Surgery
Official title: Screening of Nutritional Status and Predictors of Adverse Outcome in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2011-06-06
Enrollment: 1210
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: Patients, who live in Russia, mostly in Siberia whom scheduled to cardiac surgery in one institution.

Brief summary: Screening of nutritional status is unsolved problem in cardiac surgery. Applicability of such criteria as body mass index and albumin and screening scales (MNA, NRS-2002, SGA, SNAQ) in cardiac surgery is controversial and insufficiently studied. Furthermore, there is some known predictors of poor outcome, which closely related to nutritional status (C-reactive protein, total lymphocyte count). The aim of this study is assessment of several nutritional screening scales, objective nutritional criteria and predictors for the purpose of detection of most informative one or its combination.


Eligibility criteria: Inclusion Criteria:

* Adult patients with cardiovascular disease operated on under cardiopulmonary bypass

Exclusion Criteria:

* Age under 18 years
* Emergency
* Participation in other trial.

Primary outcomes:
measure: Mortality
timeFrame: Participants will be followed for the duration of hospital stay, an average of 4 weeks.
Secondary outcomes:
measure: Complications
timeFrame: Participants will be followed for the duration of hospital stay, an average of 4 weeks.
measure: Intensive care unit stay
timeFrame: Participants will be followed for the duration of hospital stay, an average of 4 weeks.
measure: Hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an average of 4 weeks.
measure: Ventilation time
timeFrame: Participants will be followed for the duration of hospital stay, an average of 4 weeks.
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk Research Institute of Patholgy of Circulation
Study officials:
affiliation: Novosibirsk Research Institute of Pathology of Circulation
name: Vladimir V Lomivorotov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lomivorotov VV, Efremov SM, Boboshko VA, Leyderman IN, Lomivorotov VN, Cheung AT, Karaskov AM. Preoperative total lymphocyte count in peripheral blood as a predictor of poor outcome in adult cardiac surgery. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):975-80. doi: 10.1053/j.jvca.2010.12.006. Epub 2011 Feb 26.
citation: Lomivorotov VV, Efremov SM, Boboshko VA, Nikolaev DA, Vedernikov PE, Lomivorotov VN, Karaskov AM. Evaluation of nutritional screening tools for patients scheduled for cardiac surgery. Nutrition. 2013 Feb;29(2):436-42. doi: 10.1016/j.nut.2012.08.006. Epub 2012 Nov 27.
Clinical trial NCT03714607: Laser Therapy in Managing Vaginal Prolapse
Official title: Management of Vaginal Prolapse Using Laser Therapy: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystocele
Vaginal Vault Prolapse
Rectocele
Enterocele
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy of laser therapy in postmenopausal women with symptomatic prolapse stage \>1. Assessment tools will include prolapse stage quantification system (POP-Q) and validated condition related questionnaires.

Detailed description: Postmenopausal women with symptomatic cystocele and/or rectocele stage 2 or 3 will be 1:1 randomly allocated to Er:YAG laser or watchful waiting group. Participants in the Er:YAG laser group will receive laser therapies at monthly intervals, while participants in the watchful waiting group will receive no treatment. All outcomes in both groups will be evaluated at baseline, 4-months and 6-months from baseline.

Eligibility criteria: Inclusion Criteria:

* Symptomatic prolapse stage \>1 (cystocele, vaginal vault prolapse, enterocele, rectocele) according to POP-Q System
* Negative Pap-smear

Exclusion Criteria:

* Asymptomatic prolapse
* prolapse stage \<=1
* prolapse of uterus
* presence of any type of genital infections (i.e herpes, vaginitis etc)
* vaginal bleeding
* underlying pathologies that could interfere in patients compliance (i.e psychiatric)

Primary outcomes:
measure: Pelvic Organ Prolapse Quantification System (POP-Q)
timeFrame: Change from baseline to 4-6 months
Secondary outcomes:
measure: Pelvic Floor Distress Inventory Short Form (PFDI)
timeFrame: Change from baseline το 4-6 months
measure: International Consultation on Incontinence Modular Questionnaire-Female Lower Urinary Tract Symptoms (ICIQ-FLUTS)
timeFrame: Change from baseline to 4-6 months
measure: Pelvic Floor Impact Questionnaire short Form
timeFrame: Change from baseline to 4-6 months
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire Short form
timeFrame: Change from baseline to 4-6 months
measure: Patients Global Impression of Improvement
timeFrame: 4-6 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Up to 3 months post-treatment
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Urogynecological Unit of Alexandra Hospital
Study officials:
affiliation: National and Kapodistrian University of Athens, Greece
name: Stavros Athanasiou, Associate Proffesor
role: STUDY_DIRECTOR
References:
citation: Athanasiou S, Pitsouni E, Cardozo L, Zacharakis D, Petrakis E, Loutradis D, Grigoriadis T. Can pelvic organ prolapse in postmenopausal women be treated with laser therapy? Climacteric. 2021 Feb;24(1):101-106. doi: 10.1080/13697137.2020.1789092. Epub 2020 Jul 28.
Clinical trial NCT03411707: Multiple Screening Methods for the Detection of Chinese Colorectal Advanced Adenomatous Polyps and Cancer
Official title: A Multicenter Clinical Trial for the Comparison Among Fecal Immunochemical Test, Stool DNA Test and Blood mRNA Test in Chinese Colorectal Cancer Screening
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Colorectal Adenomatous Polyp
Keywords: Colorectal cancer screening
Stool DNA test
Blood mRNA test
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Changhai Hospital
name: Tianjin Nankai Hospital
First posted: 2018-01-26
Enrollment: 1200
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants at high risk of developing colorectal cancer.

Brief summary: The primary objective is to determine the sensitivity and specificity of two Colorectal Cancer (CRC) screening methods, including stool DNA test and blood mRNA test, for colorectal cancer in Chinese population, with colonoscopy as reference method. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

The secondary objective is to compare the performance of these two CRC screening methods to a commercially available FIT assay, both with respect to cancer and advanced adenoma. Lesions will be confirmed as malignant or precancerous by colonoscopy and histopathologic examination.

Detailed description: Participants who are at high risk of developing colorectal cancer will be asked to collect two stool samples one for the stool DNA test and the other for the commercially available FIT assay, and a single blood sample for the blood mRNA test. Subjects will undergo colonoscopy within 6 months of enrollment. Representative histopathology slides from tissue biopsied or excised during colonoscopy and those from subsequent definitive surgery may be retrieved in order to be evaluated by pathologists to confirm the diagnosis and staging.

Eligibility criteria: Inclusion Criteria:

1. Subjects received screening questionnaire and had been defined as high risk.
2. Subjects haven't received any treatment under colonoscopy within 10 years.

Exclusion Criteria:

1. Subjects are under the usage of specific drugs which might affect the screening test.
2. Subjects had the contraindication for colonoscopy.

Primary outcomes:
measure: Sensitivity and Specificity of Multiple Screening Methods With Comparison to Colonoscopy, Both With Respect to Cancer.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital, Sun Yet-sen University
city: Shanghai
country: China
facility: Changhai Hospital
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yet-sen University
name: Hongzhi Zou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03263507: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers
Official title: A Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 721744, an Antisense Oligonucleotide Inhibitor of PKK, Administered Subcutaneously to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: IONIS PKK-LRx
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to Healthy Volunteers


Eligibility criteria: Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements
* Healthy males or females aged 18-65 inclusive at the time of Informed Consent
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method
* BMI \<35 kg/m2

Exclusion Criteria:

* Clinically-significant abnormalities in medical history including acute coronary syndrome, major surgery within 3 months of Screening, planned surgery that would occur during the study or physical examination or other screening results such as ECGs at Screening
* Clinically significant hematologic, chemistry, and urine abnormalities
* Treatment with another Study Drug, biological agent, or device within 4 weeks of Screening
* History of bleeding diathesis or coagulopathy
* Smoking \>10 cigarettes per day
* Considered unsuitable for inclusion by the Principal Investigator
* Current use of concomitant medications (including herbal or OTC medications) unless approved by Sponsor Medical Monitor
* Known history or positive test for HIV, hepatitis C or chronic hepatitis B
* Blood donation within 30 days of screening

Primary outcomes:
measure: Incidence and severity of adverse events that are related to treatment with Donidalorsen
timeFrame: Up to 176 days
measure: Peak plasma Concentration (Cmax) of Donidalorsen
timeFrame: Up to 176 days
measure: Time to peak plasma Concentration (Tmax) of Donidalorsen
timeFrame: Up to 176 days
measure: Effects of Donidalorsen on plasma PKK concentration
timeFrame: Up to 176 days
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Ionis Investigative Site
state: Ontario
Study officials:
References:
Clinical trial NCT06846307: The Effect of Mannitol Volume with Changes in Osmolarity in Traumatic Brain Injury
Official title: The Effect of Mannitol Volume Administration with Changes in Osmolarity in Traumatic Brain Injury: an Observational Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia
Traumatic Brain Injury
Keywords: brain injury
intracranial pressure
mannitol
neurocritical care
osmolarity
trauma
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This observational study is designed to research the effect of mannitol volume administration with changes in osmolarity in patients with traumatic brain injury to guide the safe use of mannitol in these patients.

Detailed description: This study used an analytic observational design with a prospective cohort approach to evaluate the relationship between mannitol administration volume and changes in osmolarity in TBI patients at Dr. Kariadi Central General Hospital, Semarang, Indonesia. The study included 32 non-operative TBI patients admitted to the Emergency Department (ED) and inpatient wards from November 2023 to January 2024. Samples were selected using a consecutive sampling method based on the inclusion criteria. The independent variable in this study was the volume of mannitol administered (3x125 cc, 2x250 cc, 3x250 cc; each 250 cc contains 50g mannitol) given as an IV drip for 15-20 minutes, while the dependent variable was blood osmolarity (mOsm/L).

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-40 years
* Glasgow Coma Scale (GCS) score indicating mild (14-13) or moderate (12-10)

Exclusion Criteria:

* Renal impairment
* Multiple trauma with bleeding shock
* Diabetes mellitus

Primary outcomes:
measure: Osmolarity
timeFrame: At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration
Secondary outcomes:
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Dr. Kariadi Central General Hospital
state: Central Java
Study officials:
affiliation: Universitas Diponegoro
name: Aria P Hayanto, Sp.An-TI
role: STUDY_DIRECTOR
References:
Clinical trial NCT05476107: SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects
Official title: A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Applied Molecular Transport
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Study participants will be randomized to either receive AMT-126 or placebo (Part 1), Radiolabeled tablet (Part 2)
Primary purpose: TREATMENT

Brief summary: Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

Detailed description: A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Eligibility criteria: PART 1 \& 2 (Healthy Volunteers)

Inclusion Criteria:

* Healthy male subjects and female subjects of NOCBP.
* Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
* A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
* Contraception requirements for male \& female subjects.

Exclusion Criteria:

* Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
* Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
* Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
* Evidence of current SARS-CoV-2 or COVID infection.
* Women of child-bearing potential.

Primary outcomes:
measure: Incidence of Treatment-emergent adverse events (safety and tolerability)
timeFrame: 5 days
measure: To assess the in vivo performance of an AMT-126 tablet formulation (Optional, Part 2 only)
timeFrame: 5 days
Secondary outcomes:
measure: To assess pharmacokinetics of AMT-126 in healthy volunteers
timeFrame: 5 days
Other outcomes:
Locations:
city: Ruddington
country: United Kingdom
facility: Quotient Sciences
state: Nottingham
Study officials:
References: