louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06338111: Can we Improve Mortality Prediction in Patients With Sepsis in the Emergency Department
Official title: Can we Improve Mortality Prediction in Patients With Sepsis in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis Syndrome
Emergency Department
Biomarker
Keywords: Procalcitonin
Azurocidin 1
High Sensitivity C reactive protein
Urokinase-type plasminogen activator system
Soluble triggering receptor expressed on myeloid cells - 1
Interleukin-6
Severity scores
Emergency Department
Sepsis
Septic shock
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sepsis or septic shock patients admitted to ED

Brief summary: This study aims to identify the prognostic role of procalcitonin (PCT), soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1), the soluble form of the urokinase plasminogen activator receptor (suPAR), highly sensitive C-reactive protein (hs-CRP), Interleukin-6 (IL-6), and azurocidin 1 (AZU1) in 28-day mortality for patients with sepsis in Emergency Department.

Detailed description: The levels of the specified biomarkers were measured upon patient arrival at the Emergency Department (ED) and analyzed their correlation with 28-day mortality. The values of these biomarkers were monitored over the initial three days following admission to the ED, aiming to explore their potential in guiding the de-escalation of antibiotic treatment. Considering their prognostic significance, the main goal is to develop a novel scoring system tailored for use in the emergency department setting.

Eligibility criteria: Inclusion Criteria:

* Sepsis 3 Criteria

Exclusion Criteria:

* individuals aged under 18 or above 90
* pregnant women
* individuals in custody or deprived of their liberty
* patients with associated pathologies such as severe trauma
* other types of shocks
* acute stroke
* burns
* pancreatitis myocardial infarction, pulmonary edema, status asthmatics, convulsions, drug overdose, those requiring emergency surgery
* terminal stage of neoplastic disease

Primary outcomes:
measure: Can we better predict mortality in septic patients from the Emergency Department?
timeFrame: 03.2024-05.2024
Secondary outcomes:
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Cluj County Hospital Emergency Department
state: Cluj
Study officials:
References:
Clinical trial NCT06759311: Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth
Official title: Clinical Assessment of Two Different Minimal Invasive Techniques in Caries Removal of Primary Teeth (Randomized Control Clinical Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries in Children
Keywords: Minimal Invasive Dentistry
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 88
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pain control during dental treatments is the most challenging situations that face the pediatric dentist especially in young and fearful or anxious child. Minimal invasive approach for caries removal includes many techniques to remove caries either by dental excavators, rotatory burs, atraumatic restorative treatment (ART), chemo-mechanical caries removal and smart bur.


Eligibility criteria: Inclusion Criteria:

* Each child has three teeth with carious cavity enough for insertion of hand instruments
* Positive or definitely positive child behaviour according to the Frankl Behaviour Scale (FBS)
* Caries lesion in dentin of primary teeth

Exclusion Criteria:

* Negative" or "definitely negative" child behaviour according to the FBS.
* Presence of sign and symptoms of pulp lesion

Primary outcomes:
measure: pain scores
timeFrame: Immediately after the intervention
measure: caries removal time
timeFrame: During procedure
measure: Caries removal efficacy
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Pediatric dentistry, Faculty of dentistry, pharos University, Egypt
Study officials:
References:
Clinical trial NCT04795011: Outcomes for Manual Lymphatic Drainage
Official title: Additional Manual Lymph Drainage to Standard Postoperative Rehabilitation Protocol in Primary Total Knee Arthroplasty Patients Improves Postoperative Kinesiophobia, Pain and Quality of Life: Preliminary Clinical Results
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Keywords: Total Knee Arthroplasty
Manual Lymph Drainage
Kinesiophobia
Pain
Quality of Life
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this context, the purpose of our study is to investigate the effect of MLD(manual lymphatic drainage) technique applied in addition to the standard postoperative rehabilitation protocol on pain, kinesophobia and quality of life in early periods in patients undergoing primary TKA(total knee arthroplasty) surgery. Our hypothesis is that the addition of the MLD technique to the standard postoperative rehabilitation protocol will improve the early clinical outcomes of patients undergoing primary TKA. In the future perspective, we anticipate that the data obtained as a result of our study will make a significant contribution to the relevant literature on the early and mid-term ameliorative effects of MLD on postoperative pain, kinesiophobia and quality of life, which will be possibly applied in addition to standard postoperative rehabilitation protocols in patients undergoing primary TKA.


Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 40-85
* were diagnosed with stage IV gonarthrosis
* planned primary total knee arthroplasty (TKA)
* were evaluated before the operation
* whose informed consents

Exclusion Criteria:

* Patients with postoperative pulmonary thromboembolism or treatment-related complications in the past,
* patients with osteoarthritis secondary bone or joint infections,
* patients with morbid obesity,
* patients with presence of hematological disease and malignancy,
* major cardiac pathology,
* venous insufficiency,
* patients taking high-dose anticoagulants
* patients with communication problems

Primary outcomes:
measure: Tampa Kinesiophobia Scale
timeFrame: 10 minute
measure: Visual Analog Scale (VAS)
timeFrame: 3 minute
measure: Nottingham Health Profile (NHP)
timeFrame: 10 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
References:
Clinical trial NCT01425411: Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Official title: Effect of Valsartan on Left Ventricular Myocardial Functions in Hypertensive Patients With Left Ventricular Hypertrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Left Ventricular Hypertrophy
Keywords: hypertension
left ventricular hypertrophy
angiotensin receptor blocker
midwall mechanics
tissue Doppler imaging
Hypertension with left ventricular hypertrophy
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2011-08-30
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study hypothesis: Valsartan as an angiotensin II receptor blocker treatment has beneficial effects on both midwall mechanics and myocardial functions in hypertensive patients with Left ventricular hypertrophy.


Eligibility criteria: Inclusion Criteria:

* hypertension with left ventricular hypertrophy

Exclusion Criteria:

* clinical or laboratory evidence of secondary hypertension
* heart failure
* ischemic heart disease
* valvular heart disease
* arrhythmias
* peripheral vascular disease
* chronic obstructive pulmonary disease
* neurologic disorders
* diabetes mellitus
* renal dysfunction
* notable systemic disease

Primary outcomes:
measure: change from baseline in midwall fractional shortening (mFS) and tissue Doppler systolic wave (Sm) measured by echocardiography at six months
timeFrame: six months
Secondary outcomes:
measure: change from baseline in systolic and diastolic blood pressure at six months
timeFrame: six months
measure: change from baseline in left ventricular mass index measured by echocardiography at six months
timeFrame: six months
Other outcomes:
Locations:
city: Antioch
country: Turkey
facility: Mustafa Kemal University School of Medicine, Department of Cardiology
Study officials:
affiliation: Mustafa Kemal University: Turkey
name: Fatih Yalcin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kucukler N, Kurt IH, Topaloglu C, Gurbuz S, Yalcin F. The effect of valsartan on left ventricular myocardial functions in hypertensive patients with left ventricular hypertrophy. J Cardiovasc Med (Hagerstown). 2012 Mar;13(3):181-6. doi: 10.2459/JCM.0b013e3283511f00.
Clinical trial NCT04147611: Remote Microphone (RM) - A Comparative Study
Official title: Remote Microphone (RM) Technology in Children Using Bone Conduction Devices: A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss, Conductive
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Cochlear
First posted: 2019-11-01
Enrollment: 22
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology. In this study, two remote microphone technologies will be evaluated to determine benefit in speech understanding in noise.


Eligibility criteria: Pediatric RM Technology Group:

Inclusion Criteria:

* English speaking pediatric conduction device users and their guardian/s will be included for study.
* We will include pediatric patients 5 years of age to 17 years of age who have a conductive or mixed unilateral or bilateral hearing loss with a minimum of a 30 decibels (dB) air-bone gap.

Exclusion Criteria:

- Participants who do not meet the described inclusion criteria.

Normal Hearing Controls:

Inclusion Criteria:

* Adults greater than18 years of age.
* Hearing thresholds \< 25 dB 500 - 4,000 Hz.

Exclusion Criteria:

- Non-English speakers.

Primary outcomes:
measure: Percentage of Correct Word Responses
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Kristine Harris
state: Florida
Study officials:
affiliation: University of Miami
name: Hillary Snapp, AuD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02223611: Clinical Observation of S1 Capsule for Stage Ⅱ-ⅢA Non-small Cell Lung Cancer After Complete Resection
Official title: Phase ⅡTrial of S1 Capsule Plus Cisplatin Versus Vinorelbine Plus Cisplatin as Adjuvant Treatment in Stage Ⅱ-ⅢA Non-small Cell Lung Cancer (NSCLC) After Complete Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Stage Ⅱ
Non-small Cell Lung Cancer Stage ⅢA
Keywords: Stage Ⅱ-ⅢA NSCLC S1 capsule Completely resection
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2014-08-22
Enrollment: 100
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: The purpose of this study is to evaluate S1 capsule plus Cisplatin as adjuvant treatment in stageⅡ and Ⅲa non-small cell lung cancer. It is the first study in the world to investigate the safety and efficacy of S1 capsule using in stageⅡ and Ⅲa non-small cell lung cancer patients after the complete resection.

Detailed description: Lung cancer is the leading cause of cancer death worldwide. Only about 15.6% of all lung cancer patients are alive 5years or more after diagnosis. Non-small Cell Lung Cancer (NSCLC) accounts for more than 85% of all lung cancer cases.

For individuals with stage Ⅱ-ⅢA NSCLC after complete resection, platinum-based chemotherapy is the mainstay of first line treatment. Various treatment regimens have been developed to improve survival.

S-1 capsule is an novel oral anticancer drug that combines tegafur, a prodrug of 5-fluorouracil, with gimeracil and oteracil potassium. S-1 capsule was considered to be an active single agent against NSCLC.

Eligibility criteria: Inclusion Criteria:

* Patient with completely resected stage ⅢA non-small cell lung cancer(NSCLC)
* Must be able to receive the therapy of the study within four weeks after the completely resection

Exclusion Criteria:

* Systemic anticancer treatment
* local radiotherapy

Primary outcomes:
measure: Disease free survival rate
timeFrame: 2 years
Secondary outcomes:
measure: Disease free survival
timeFrame: 4 years
measure: Overall survival
timeFrame: 4 years
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
measure: Quality of life (QOL)
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks.
Other outcomes:
measure: Molecular marker measurement for NSCLC
timeFrame: Some molecular markers in the serum will be tested at 6-month intervals after surgery until recurrence
Locations:
city: Shijiazhuang
country: China
facility: Jun Feng Liu
state: Hebei
Study officials:
affiliation: Department of Thoracic Surgery Fourth Hospital, Hebei Medical University, China
name: Jun-Feng Liu, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01608711: A Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
Official title: An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Cancer
Carcinoma, Pancreatic Ductal
Pancreatic Disease
Keywords: Gemcitabine
ASP6182
AGS-1C4D4
Pancreatic Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 2
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: The purpose of this study is to continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.

Detailed description: Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. If subjects have grade 4 adverse events considered to be related to AGS-1C4D4 at anytime during the study, AGS-1C4D4 treatment will be discontinued for that subject.

Subjects will continue to have their tumor status assessed by computerized tomography (CT) and magnetic resonance (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) guidelines every eight weeks (Q8W). Subjects without evidence of disease progression will continue to receive AGS-1C4D4 and gemcitabine until intolerability, disease progression or consent withdrawal.

Subjects who discontinue AGS-1C4D4 for any reason will undergo an end of study visit 4 weeks after their last AGS-1C4D4 infusion.

Eligibility criteria: Inclusion Criteria:

* Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002

Exclusion Criteria:

* More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002
* Use of the following prohibited medications / therapies:

  * Monoclonal antibody therapy, other than AGS-1C4D4
  * Chemotherapy, other than gemcitabine
  * Investigational therapy other than AGS-1C4D4
  * Erlotinib (Tarceva)
* Any clinical condition which would not allow safe conduct of this study

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 31 months
measure: Incidence of anti-AGS-1C4D4 antibody formation
timeFrame: Every 8 weeks (up to 31 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Site US116
state: Wisconsin
city: Toronto
country: Canada
facility: Site CA00203
Study officials:
affiliation: Agensys, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01153711: Relative Bioavailability of of Olodaterol and Ketoconazole
Official title: Relative Bioavailability of 10 mcg Olodaterol (Solution for Inhalation Administered With the Respimat) at Steady State Alone or in Combination With Multiple Doses of 400 mg q.d. Ketoconazole (Tablet) in Healthy Male and Female Volunteers (an Open Label, Fixed Sequence, Phase I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2010-06-30
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is intended to investigate a possible effect of the p-gp inhibitor ketoconazole on the bioavailability of olodaterol


Eligibility criteria: Inclusion criteria Healthy male and female volunteers

Exclusion criteria

Primary outcomes:
measure: Area Under Curve From 0 to 1 Hour at Steady State (AUC0-1,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Maximum Concentration at Steady State (Cmax,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
Secondary outcomes:
measure: Time From Dosing to the Maximum Concentration at Steady State (Tmax,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Fraction of Urine Excretion From 0 to 24 Hours at Steady State (fe0-24,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Amount of the Analyte Excreted in Urine From 0 to 24 Hours at Steady State (Ae0-24,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Area Under Curve From 0 to 8 Hours at Steady State (AUC0-8,ss)
timeFrame: Day 8 of period 1 and day 14 of period 2
measure: Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis and ECG
timeFrame: First administration of trial medication until 6 days after last administration of trial medication
measure: Assessment of Tolerability by the Investigator
timeFrame: End of period 1 and end of period 2
Other outcomes:
Locations:
city: Ingelheim
country: Germany
facility: 1222.47.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT02365311: Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function During One-lung Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-assisted Thoracic Surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-02-18
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The investigators used transesophageal echocardiography (TEE) to assess the change of pulmonary blood flow and bi-ventricular function during lung isolation. The investigators hypothesized that changes in pulmonary venous flow with lung isolation may be related the shunt fraction and oxygenation during one lung ventilation (OLV). The investigators also observed the cardiac function during two lung ventilation (TLV) and OLV in supine and lateral position by TEE.


Eligibility criteria: Inclusion Criteria:

* Above 20 years of age.
* American Society of Anesthesiologists (ASA) Physical Status I and II
* Thoracic surgical procedure (video-assisted)

Exclusion Criteria:

* severe functional liver or kidney disease
* cardiac disease
* arrhythmia
* exceed BMI \> 30 kg/ m2
* COPD
* pathologic esophageal lesion (esophageal stricture or varix )
* pregnancy

Primary outcomes:
measure: The change of pulmonary blood flow
timeFrame: two-lung ventilation in the supine (T1) and lateral position (T2) and 10 (T3), 20 (T4), and 30 min (T5) during OLV in the left lateral decubitus position.
Secondary outcomes:
measure: The changes of respiratory parameters
timeFrame: two-lung ventilation in the supine (T1) and lateral position (T2) and 10 (T3), 20 (T4), and 30 min (T5) during OLV in the left lateral decubitus position.
measure: The change of cardiac function
timeFrame: two-lung ventilation in the supine (T1) and lateral position (T2) and 10 (T3), 20 (T4), and 30 min (T5) during OLV in the left lateral decubitus position.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References: