louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02490644: Role of High Mobility Group Box 1 as a Prognostic Biomarker in Patients Undergoing Valvular Heart Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Valvular Heart Disease
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-07-07
Enrollment: 250
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: people who undergo valvular heart surgery

Brief summary: One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

Detailed description: One of the most important factor that affects the post op complication of the cardiac surgery is systemic inflammation. Valvular heart surgery requires cardiopulmonary bypass and cardioplegic arrest, which can arouse the ischemic/reperfusion injury causing myocardial damage and inflammatory response. These myocardial damage and inflammatory response can cause multi-organ failure or even death.

High-mobility group protein B1 (HMGB1) is a protein which is encoded by the HMGB1 gene in human. HMGB1 is secreted by immune cells (like macrophages, monocytes and dendritic cells). Activated macrophages and monocytes secrete HMGB1 as a cytokine mediator of Inflammation. There are many studies suggesting the relationship between HMGB1 and acute coronary syndrome, myocardial ischemic/reperfusion injury, atherosclerosis, heart failure and other cardiac disease as a marker for inflammatory response. However, there are no other study evaluating HMGB1 as a prognostic factor after valvular surgery, so far.

Eligibility criteria: Inclusion Criteria:

* age ≥ 20
* patients undergoing aortic valve surgery or more than single valve surgery

Exclusion Criteria:

* age \< 20
* patients undergoing single mitral valve surgery
* history of open heart surgery
* emergency surgery
* history of steroid medication
* infective disease and/or malignant tumor
* coronary artery bypass surgery or aortic replacement surgery

Primary outcomes:
measure: concentration of HMGB1
timeFrame: collect blood sample right before the surgery after induction of anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03149744: Mixed Methods Evaluation of a Novel Apnoea Event Detection Monitor
Official title: A Mixed-methods Evaluation of a Novel Apnoea Event Detection Monitor in Comparison to Standard of Care Limited Overnight Polysomnography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Rate
Lead sponsor: PMD Solutions
Sponsor class: INDUSTRY
Collaborators: name: Portsmouth Hospitals NHS Trust
First posted: 2017-05-11
Enrollment: 127
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 due to undergo standard of care home sleep testing

Brief summary: This investigation is looking at a currently available technology to see if it could have another use i.e. in helping to diagnose patients with sleep apnoea.

With 2-4% of the population suffering from this disease, and the current wait time for a test at approximately 20 weeks, it is hoped that a simple screening method could help speed up the process of finding these patients and getting them on treatment faster.

The current standard of care test involves a sleep study in the patients own home with a device with multiple parts and wires. The RespiraSense Sleep Screener is completely cableless and consists of one small, discrete unit attached to the patients side and a mobile device plugged in by the bed.

Patients at Queen Alexandra Hospital who are prescribed sleep studies will be invited to participate. The RespiraSense Sleep Screener data is only for comparison purposes and will have no effect on their clinical care.

If patients agree to participate they will undergo the sleep study with both devices in the same night and may be followed up with over the phone on their experiences with the test.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 Years
* Patients due to undergo home monitoring to investigate presence of sleep apnoeic events
* Patients able to provide informed consent to participate in this investigation

Exclusion Criteria:

* Patients with known respiratory disorders that are uncontrolled at the time of the sleep study
* Patients allergic to medical grade skin adhesive
* Patients on long term, oral steroid use
* Pregnant women during second and third trimester
* Patients presently on any sleep disorder therapy
* Patients with any history of substance abuse (drug or alcohol) that may interfere with their ability to cooperate and comply with the investigation procedures
* Patients with any disorder, including cognitive dysfunction, which would affect the ability to accurately complete questionnaires and freely give full informed consent

Primary outcomes:
measure: Similarity to standard of care
timeFrame: One night
Secondary outcomes:
measure: Qualitative evaluation of RespiraSense
timeFrame: One night
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
Study officials:
affiliation: Portsmouth Hospitals NHS Trust
name: Anoop Chauhan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00580944: Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Official title: Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Port Wine Stain
Keywords: Port wine stain
progressive malformation of human skin
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2007-12-27
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Port wine stain is a congenital, progressive vascular malformation of skin involving post-capillary venules that occurs in an estimated 4 children per 1,000 live births. Approximately 1,200,000 individuals in the United States and twenty-six million people worldwide have Port wine stain birthmarks.

Since most of the malformations occur on the face, Port wine stain is a clinically significant problem in the majority of patients. Port wine stain should not be considered a cosmetic problem but a disease with potentially devastating psychological and physical complications. Personality development is adversely influenced in virtually all patients by the negative reaction of others to a "marked" person. Port wine stain are initially flat red macules, but lesions tend to darken progressively to purple, and by middle age, often become raised as a result of the development of vascular nodules. Hypertrophy of underlying soft tissue further disfigures the facial features of many patients.

Detailed description: The researcher can use alexandrite and pulsed dye lasers pulses combined delivery to improve port wine stain blanching. The alexandrite and pulsed dye lasers are both approved by the Food and Drug Administration for the treatment of Port wine stain. However, the degree of port wine stain blanching seen following either alexandrite or pulsed dye lasers treatment remains variable and unpredictable. Treatment of port wine stains can use either alexandrite or pulsed dye alone and with the combined delivery of alexandrite and pulsed dye lasers pulses.

Eligibility criteria: Inclusion Criteria:

* Port Wine Stain suitable for comparison testing
* Age \> 12 years and older
* minor will be accompanied by parents or guardians during laser treatment
* Apparent good health as documented by medical history

Exclusion Criteria:

* History of photodermatoses or skin cancer
* Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
* Current participation in any other investigational drug or device evaluation
* Concurrent use of known photosensitizing drugs

Primary outcomes:
measure: Port Wine Stain Birthmarks blanching
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Beckman Laser Institute
name: JOHN S NELSON, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03234244: HDDO-1614 Intervention Trial
Official title: A Randomized, Open-label, Single-dose Study to Evaluate the Safety and the Pharmacokinetics After Oral Concurrent Administration of HDDO-16141 and HDDO-16142 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Osteoporosis
Lead sponsor: Hyundai Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2017-07-31
Enrollment: 37
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study


Eligibility criteria: Inclusion Criteria:

* Body weight 50kg ≤ / BMI=18\~29kg/㎡
* A person who is determined to be eligible for the test through a physical examination or an interview
* Those who have been judged to be eligible for the clinical laboratory tests such as hematology test, blood chemistry test, urine test, urine test, serology test

Exclusion Criteria:

* Patients with clinically significant liver, pancreas, kidney, nervous system, respiratory, endocrine, hematologic, mental, cardiovascular
* Patients with a history of gastrointestinal disorders or history of gastrointestinal surgery that may affect the absorption of pharmaceuticals for clinical trials
* Any person who shows any of the following results in the screening test

  1. AST or ALT \> 2 times upper limit of normal range
  2. Total Bilirubin \> 2.0mg/dL
  3. Glomerular filtration rate (eGFR) \< 60mL / min/ 1.7㎡
* Those who show signs of hypotension (systolic blood pressure ≤ 100mmHg or diastolic blood pressure ≤ 55mmHg) or Hypertension (systolic blood pressure ≥ 150mmHg or diastolic blood pressure ≥ 95mmHg)
* Those who have a history of drug abuse or who have a positive urine drug test

Primary outcomes:
measure: Drug-Drug Interaction
timeFrame: Day 1~Day 56
Secondary outcomes:
measure: Pharmacokinetic Assessment
timeFrame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
measure: Pharmacokinetic Assessment
timeFrame: 0, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, 12, 24, 48, 72, 96 and 120 hours
measure: Pharmacokinetic Assessment
timeFrame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
measure: Pharmacokinetic Assessment
timeFrame: Pre-dose: -24, -18, -12, 0 hour, Post-dose: 2, 4, 6, 8, 10, 12, 14, 16, 24, 36, 48, 72, 96 hour
Other outcomes:
Locations:
city: Junggu
country: Korea, Republic of
facility: Inha University Hospital
state: Incheon
Study officials:
affiliation: Inha University Hospital
name: Sang-Heon Cho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04941144: Long-Term Follow-up Survey of COVID-19 Vaccine After Vaccination
Official title: General Use Results Survey: Spikevax Intramuscular Injection (Previously COVID-19 Vaccine Moderna Intramuscular Injection) During the Early Phase of Treatment With Novel Corona Vaccine, Follow-up of Key Survey Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease (COVID-19)
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2021-06-28
Enrollment: 8538
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are vaccinated participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a long-term follow-up survey of Japanese people after their second vaccination with the Moderna COVID-19 vaccine.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for long-term side effects of the COVID-19 vaccine. This will be from 28 days to 12 months after the second vaccination of the COVID-19 vaccine.

The number of visits to the clinic will depend on the clinic's standard practice.


Eligibility criteria: Inclusion Criteria:

Participants who have participated in the preceding cohort study and has subsequently provided written consent to participate in this study.

Exclusion Criteria:

None

Primary outcomes:
measure: Percentage of Participants with Serious Adverse Events (SAE)
timeFrame: 11 months (From 28 days to 12 months after the second vaccination)
Secondary outcomes:
measure: Number of Participants who Take COVID-19 Pathogen (Severe Acute Respiratory Syndrome coronavirus [SARS-CoV-2]) Test during the Study
timeFrame: 11 months (From 28 days to 12 months after the second vaccination)
measure: Number of Participants who Developed COVID-19 during the Study
timeFrame: 11 months (From 28 days to 12 months after the second vaccination)
measure: Number of Participants Who Have Severe COVID-19 Infection during the Study Evaluated by Investigator
timeFrame: 11 months (From 28 days to 12 months after the second vaccination)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Moderna selected site
Study officials:
References:
Clinical trial NCT04335344: Role of suPAR in Periodontitis and CVD
Official title: Evaluation of Plasma and Salivary suPAR in Periodontitis and CVD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Disturbance
Periodontal Diseases
Lead sponsor: University of Messina
Sponsor class: OTHER
Collaborators: name: University of Catania
First posted: 2020-04-06
Enrollment: 326
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects (n=33) and patients with periodontitis (n=35), CVD (n=34), and a combination of periodontitis + CVD (n=34) were enrolled in the present study.

Brief summary: soluble urokinase-type plasminogen activator receptor (suPAR) plays a key role in endothelial function and may be a link for the known interaction of periodontitis and cardiovascular disease (CVD). The investigators compared the impact of gingival health, periodontitis (CP), CHD or of both diseases (CP+CHD) on saliva and serum suPAR levels.

Detailed description: The aim of this study was to evaluate a possible association between both saliva and serum suPAR levels in patients with CP and with CVD and if the serum suPAR levels are mediated by serum CRP.

Eligibility criteria: Inclusion Criteria:

* Presence of at least 15 teeth
* CP with a minimum of 40% of sites with a clinical attachment level (CAL) ≥2mm and probing depth (PD) ≥4mm;
* Presence of at least ≥2 mm of crestal alveolar bone loss verified on digital periapical radiographs
* Presence of ≥40% sites with bleeding on probing (BOP)

Exclusion Criteria:

* Intake of contraceptives
* Intake of immunosuppressive or anti-inflammatory drugs throughout the last three months prior to the study
* Status of pregnancy or lactation
* Previous history of excessive drinking
* Allergy to local anaesthetic
* Intake of drugs that may potentially determine gingival hyperplasia such as Hydantoin, Nifedipine, Cyclosporin A or similar drugs.

Primary outcomes:
measure: Clinical attachment level
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University of Messina
Study officials:
affiliation: University of Messina
name: Giovanni Matarese
role: STUDY_CHAIR
References:
Clinical trial NCT03028844: The Effect of a Musical Intervention on Stress Response to Venepuncture
Official title: The Effect of a Musical Intervention on Stress Response to Venepuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Stress, Physiological
Keywords: Neonate
preterm
pain
music
EEG
venepuncture
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 23
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and sucrose versus sucrose on stress

Detailed description: The purpose of this study is to assess whether the use of music therapy as a non-pharmacological intervention around the time of venepuncture significantly decreases the stress response of a stable preterm neonate, as measured by salivary cortisol levels .

The secondary aim of this study is to analyse the effect of music therapy on the EEG, and vital signs of the stable preterm neonate.

Eligibility criteria: Inclusion Criteria:

* Infants born at less than 32 weeks gestational age (from 23+0 weeks' up to and including 31+6 weeks' gestational age)
* Infants must now be \>32 weeks corrected gestational age
* Infants who are medically stable and due to have routine venepuncture as part of their management plan

Exclusion Criteria:

* Inability to obtain informed consent from parent
* Infants with known hearing impairment
* Infants receiving sedative medications
* Any evidence of dysfunction of the hypothalamic-pituitary-adrenal axis
* Infants with congenital abnormalities
* Infants with known EEG abnormalities

Primary outcomes:
measure: Salivary cortisol levels
timeFrame: BASELINE, 20 mins and 4 hours
Secondary outcomes:
measure: Premature Infant Pain Profile (PIPP) score
timeFrame: immediate
measure: Changes in physiological parameters - Heart rate
timeFrame: 10 mins before venepuncture and 10 mins after
measure: Changes in physiological parameters - respiration rate
timeFrame: 10 mins before venepuncture and 10 mins after
measure: Changes in physiological parameters - oxygen saturation
timeFrame: 10 mins before venepuncture and 10 mins after
measure: Changes in physiological parameters - EEG
timeFrame: 10 mins before venepuncture and 10 mins after
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Cork University Maternity Hospital
Study officials:
References:
Clinical trial NCT04003792: Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
Official title: Treatment With Hepatic Arterial Infusion of Oxaliplatin in Combination With Systemic FOLFIRI Chemotherapy and Bevacuzimab in Patients With Liver-only Colorectal Liver Metastases (CRLM): Conversion to Complete Resection in Patients With Initially Inoperable Liver-only CRLM.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Metastasis Colon Cancer
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2019-07-01
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A few studies have documented that some patients can be down-staged from an initially inoperable state to a potentially resectable state. Five-year survival in initially inoperable patients that ultimately come to a complete resection appears to be similar to patients who are resected at first presentation. The investigators goal is to assess the rate of conversion to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.


Eligibility criteria: Subject Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma metastatic to the liver.
* The patient must have inoperable liver metastases as agreed upon by any two hepatobiliary surgeons and the assigned radiologist.
* A patient may have had prior chemotherapy or be previously untreated.
* ECOG PS \<2

Subject Exclusion Criteria:

* Prior radiation, hepatic thermo ablation or resection (other than biopsy) to the liver.
* Patient may not have received prior treatment with hepatic artery infusion (HAI).
* Extrahepatic metastases
* Female patients who are pregnant or lactating

Primary outcomes:
measure: conversion rate to complete resection in patients with initially inoperable liver-only metastases due to colorectal cancer after treatment with HAI of oxaliplatin with FOLFIRI and bevacuzimab systemic treatment.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References: