louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03235193: Predictive algoRithm for EValuation and Intervention in SEpsis
Official title: Prediction of Severe Sepsis Using a Machine Learning Algorithm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Septic Shock
Severe Sepsis
Lead sponsor: Dascena
Sponsor class: INDUSTRY
Collaborators: name: Cabell Huntington Hospital
First posted: 2017-08-01
Enrollment: 2296
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: In this prospective study, the ability of a machine learning algorithm to predict sepsis and influence clinical outcomes, will be investigated at Cabell Huntington Hospital (CHH).


Eligibility criteria: Inclusion Criteria:

* All adult patients visiting the emergency department, or admitted to the participating intensive care unit (ICU) wards of Cabell Huntington Hospital will be eligible.

Exclusion Criteria:

* All patients younger than 18 years of age will be excluded.

Primary outcomes:
measure: In-hospital mortality
timeFrame: Through study completion, an average of 30 days
Secondary outcomes:
measure: Hospital length of stay
timeFrame: Through study completion, an average of 30 days
Other outcomes:
measure: Hospital readmission
timeFrame: Through study completion, an average of 30 days
measure: ICU length of stay
timeFrame: Through study completion, an average of 30 days
Locations:
city: Huntington
country: United States
facility: Cabell Huntington Hospital
state: West Virginia
Study officials:
affiliation: Cabell Huntington Hospital
name: Hoyt Burdick
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calvert J, Desautels T, Chettipally U, Barton C, Hoffman J, Jay M, Mao Q, Mohamadlou H, Das R. High-performance detection and early prediction of septic shock for alcohol-use disorder patients. Ann Med Surg (Lond). 2016 May 10;8:50-5. doi: 10.1016/j.amsu.2016.04.023. eCollection 2016 Jun.
citation: Calvert JS, Price DA, Chettipally UK, Barton CW, Feldman MD, Hoffman JL, Jay M, Das R. A computational approach to early sepsis detection. Comput Biol Med. 2016 Jul 1;74:69-73. doi: 10.1016/j.compbiomed.2016.05.003. Epub 2016 May 12.
citation: Desautels T, Calvert J, Hoffman J, Jay M, Kerem Y, Shieh L, Shimabukuro D, Chettipally U, Feldman MD, Barton C, Wales DJ, Das R. Prediction of Sepsis in the Intensive Care Unit With Minimal Electronic Health Record Data: A Machine Learning Approach. JMIR Med Inform. 2016 Sep 30;4(3):e28. doi: 10.2196/medinform.5909.
Clinical trial NCT05577793: Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application
Official title: Effect of Therapeutic Touch and Mother's Voice on Pain and Comfort Level During Nasal CPAP Application in Turkey: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Nasal Continuous Positive Airway Pressure
Pain Management
Keywords: Nasal continuous positive airway pressure (NCPAP)
Therapeutic Touch
Mother's Voice
Pain
Comfort
Lead sponsor: Bozok University
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 124
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study used a randomized controlled trial. A parallel trial design was used describing three different experimental groups (Therapeutic Touch, Mother's Voice, and Therapeutic Touch+Mother's Voice) and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.

Detailed description: Aim: This study was conducted to evaluate the effects of Therapeutic Touch and Mother's Voice on pain and comfort levels of preterm infants during nasal CPAP application.

Design and Method: The study, which used a randomized controlled trial, included 124 preterm neonatal infants a gestational age of 28- 37 weeks and received nasal CPAP. The infants were treated with Mother's Voice, Therapeutic Touch, and Mother's Voice+ Therapeutic Touch. The Neonatal Infant Pain Scale (NIPS) and Premature Infant Comfort Scale (PICS) scores of the infants were measured before, during and after the nasal CPAP application.

Eligibility criteria: Inclusion Criteria:

* being checked in at Neonatal Intensive Care Unit
* being in the gestational ages of 28 to 37 weeks
* having nasal CPAP

Exclusion Criteria:

* having neurological disorders
* having comorbidity
* receiving sedation or analgesics
* having congenital anomaly
* receiving extra invasive procedures or surgical intervention
* being diagnosed with hearing loss

Primary outcomes:
measure: Neonatal Infant Pain Scale (NIPS)
timeFrame: 15 minutes
measure: Premature Infant Comfort Scale (PICS)
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Cengiz Gökçek Gynecology, Obstetrics and Pediatrics Hospital
Study officials:
affiliation: Bozok University
name: Ayşe Belpınar, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Inonu University
name: Emriye Hilal Yayan, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06824493: Orthodontic Treatment on Oral Microbiota and Salivary Proteins
Official title: Orthodontic Treatment on Oral Microbiota and Salivary Proteins
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orthodontics
White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Caries, Dental
Keywords: microbiota
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A description of the population from the population undergoing oral health examinations in primary schools

Brief summary: Study on the changes in oral microbiota during orthodontic treatment in patients aged 8-18 years. Orthodontic patients treated at Stomatology Hospital of Xi'an Jiaotong University from March 2025 to March 2027 will be recruited. Prior to orthodontic treatment, routine preoperative examinations will be conducted, informed consent forms will be signed, baseline oral conditions will be recorded, and oral and psychological-related questionnaires will be completed. Patients will be informed of the need for regular oral hygiene check-ups, caries risk assessments will be performed, and plaque, saliva, and intraoral photographs will be collected. During orthodontic treatment, plaque samples will be collected every 3 months, and saliva samples will be collected every 6 months until the treatment is completed to evaluate the changes in oral microbiota throughout the orthodontic process.


Eligibility criteria: Inclusion Criteria:

* No carries and White spot
* No missing teeth
* No history of oral treatment
* No malocclusion
* No systemic diseases

Exclusion Criteria:

* Antibiotic use in the past three months
* A history of long-term medication use
* A history of dental fillings
* Unable to attend regular follow-ups

Primary outcomes:
measure: Microbiota changes of plaque
timeFrame: baseline, collect plaque in the first month, then at Month 3, 6, 9, 12, 15, 18, 21, 24, 27,30 through study completion, an average of 30 months.
measure: Microbiota changes of saliva
timeFrame: Baseline, collect saliva at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.
measure: Monitoring dental lesion progression
timeFrame: Baseline, follow-up assessments are conducted at Months 6, 12, 18, 24, 30 through study completion, an average of 30 months.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03938493: Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia
Official title: Observation of the Pressure Changes of the Endotracheal Tube Cuff in the Head and Neck Surgery Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation, Intratracheal
Keywords: Adults who require endotracheal intubation for head and neck surgery under general anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who require endotracheal intubation for head and neck surgery under general anesthesia

Brief summary: Endotracheal tube is a commonly used for general anesthesia in head and neck surgery. It is necessary to place the endotracheal tube in the trachea of the patient and then inflate the cuff with air. This is because the air-inflated cuff contacts the inner wall of the patient's trachea to deliver oxygen through the tube. If the cuff does not inflate, oxygen will leak through the space between the cuff and the patient's trachea. In addition, the risk of pneumonia increases. Therefore, after placing the endotracheal tube in the patient's trachea, the cuff is immediately inflated with air. However, when the cuff is inflated using an excess of air, the cuff may pressurize the mucous membrane of the tracheal wall and cause ischemia. Pressure in the over-inflated cuff was also found to be associated with post-operative sore throat, vocal cord paralysis, and nerve damage. Therefore, appropriate amount of air should be used to inflate the cuff into the air and adjust the pressure within the cuff to be within the range of 20-30 cmH2O. The authors thought that the pressure in the cuff could be changed during the operation due to various factors and that the pressure in the cuff should be monitored continuously. In this study, the investigators will monitor the cuff pressure during anesthesia and analyze the factors affecting the cuff pressure.


Eligibility criteria: Inclusion Criteria:

* 1. Adults who require endotracheal intubation for head and neck surgery under general anesthesia

Exclusion Criteria:

* 1. Patients under 20 years old
* 2. Patients who should undergo tracheostomy
* 3. Patients who need to use an endotracheal tube without a cuff
* 4. Pregnant women
* 5. Patients who can not read the consent form or are not fluent in Korean
* 6. Patients who refused the clinical trial

Primary outcomes:
measure: Changes of cuff pressure during anesthesia
timeFrame: participants will followed until post-operative 1 day.
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 NCT02214693: PK//PD/Tolerability Study of DA-1229(Evogliptin) in Renal Impaired Patients
Official title: A Clinical Study to Investigate the Pharmacokinetics/Pharmacodynamics and Tolerability of DA-1229(Evogliptin) Tablet in Renal Impaired Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Keywords: patients
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This is a clinical study to investigate the pharmacokinetics/pharmacodynamics and tolerability of DA-1229(Evogliptin) tabletin renal impaired patients.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 70
* Weights between 50 and 90kg(Female : 40 and 90kg)
* Volunteer who totally understands the progress of this clinical trials, makes decision by his free will, and signed a consent form to follow the progress
* Stable results of estimated GFR in 4 months recently

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
* Volunteer who had drug(DPP-4 inhibitor) hypersensitivity reaction
* Volunteer who already participated in other trials in 2 months
* Volunteer who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion

Primary outcomes:
measure: Area Under Curve(AUC) last
timeFrame: Pre-dose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48, 60, 72, 96, 120h post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00289393: Response Shift in Patient Expectations and Functional Outcome
Official title: Response Shift in Patient Expectations and Functional Outcome Following Posterior Lumbar Spinal Surgery for Degenerative Spinal Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Injuries
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2006-02-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The purpose of this study is to evaluate the results of elective lumbar spinal surgery as it relates to shifting patient expectations for outcome. Patients undergoing elective posterior spinal surgery for degenerative conditions of the spine at SWCHSC will be evaluated.


Eligibility criteria: Inclusion Criteria:

* All patients with a diagnosis of a degenerative condition of the lumbar spine undergoing posterior lumbar spinal surgery at Sunnybrook and Women's College Health Sciences Centre
* Patients who have had previous lumbar surgery

Exclusion Criteria:

* Traumatic or neoplastic surgical conditions of the lumbar spine

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Dr. Joel Finkelstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03892993: Patient Decision Aid in Supporting Decision-Making About When to Start or Stop New Drugs, Join Clinical Trials, or Continue Active Surveillance in Patients With Medullary Thyroid Cancer and Their Caregivers
Official title: Designing a Decision Aid to Help People With Medullary Thyroid Cancer Make Decisions With Their Doctors About Whether to Start or Stop New Drugs, Enroll in Clinical Trials, or Continue With Active Surveillance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thyroid Gland Medullary Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This trial develops and studies how well a patient decision aid works in supporting decision-making about when to start or stop new drugs, join clinical trials, or continue active cancer monitoring for patients with medullary thyroid cancer and their caregivers. Developing a patient decision aid may help patients with medullary thyroid cancer make well-informed decisions about their cancer care and be able to discuss their preferences with their doctors.

Detailed description: PRIMARY OBJECTIVES:

I. To assess patient/survivor, caregiver/family member, and provider decision-making needs.

II. To design and develop an initial patient decision aid prototype. III. To pilot test its acceptability. IV. To evaluate the acceptability and usability of the decision aid prototype from patients/survivors, caregivers and providers in a real world environment.

OUTLINE:

Participants use decision aid and complete questionnaire.

Eligibility criteria: Inclusion Criteria:

* Aged 18 years old or older
* Have or will face(d) this decision, including: Patient/survivor - who has medullary thyroid carcinoma, as determined by a clinician or documented in the Genetics of Endocrine Neoplasia Registry or sporadic (medullary thyroid carcinoma) MTC database; Caregiver/family member - of patient/survivor who has medullary thyroid carcinoma, as nominated by the patient/survivor; and Provider - who treats patients/survivors who have medullary thyroid carcinoma, as described above
* Able to speak, read, and write English
* Pregnant patients are included

Exclusion Criteria:

--Individuals with cognitive or psychological impairment (e.g., depression, anxiety, severe mental illness; as documented in the registry)

Primary outcomes:
measure: Needs assessment
timeFrame: Up to 1 year
measure: Decision aid design refining (storyboarding)
timeFrame: Up to 1 year
measure: Decision aid acceptability
timeFrame: Up to 1 year post decision aid
measure: Real World Evaluation
timeFrame: Up to 1 year post
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Elizabeth G Grubbs, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219193: A Clinical Study to Evaluate the Safety and Efficacy of the Combination of Aliskiren and Valsartan in Hypertensive Non Responders Patients
Official title: An Eight Week, Multicenter Study to Evaluate Efficacy and Safety of the Triple Combo of Aliskiren /Valsartan/HCTZ (300/320/25 mg), Compared to the Double Combos of Aliskiren/HCTZ (300/25 mg) or Valsartan/HCTZ (320/25 mg) in Patients With Essential Hypertension Not Adequately Responsive to HCTZ 25 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, valsartan, HCTZ
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 641
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the blood pressure lowering effect and safety of the triple combination aliskiren / valsartan / HCTZ (300/320/25 mg) in patients with essential hypertension not adequately responsive to HCTZ 25 mg


Eligibility criteria: Inclusion Criteria

* Patients with essential hypertension
* Patients who are eligible and able to participate in the study

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Change from baseline in diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in systolic and diastolic blood pressure after 4 weeks and 8 weeks
measure: Change from baseline in standing blood pressure after 4 weeks and 8 weeks
measure: Achieve blood pressure control target of < 140/90 mmHg after 8 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Geiger H, Barranco E, Gorostidi M, Taylor A, Zhang X, Xiang Z, Zhang J. Combination therapy with various combinations of aliskiren, valsartan, and hydrochlorothiazide in hypertensive patients not adequately responsive to hydrochlorothiazide alone. J Clin Hypertens (Greenwich). 2009 Jun;11(6):324-32. doi: 10.1111/j.1751-7176.2009.00114.x.
Clinical trial NCT02083393: Changes of Dendritic Cells in Acute Lung Injury
Official title: Changes of Dendritic Cells in Acute Lung Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Keywords: dendritic cell
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sepsis induced-ALI patients with mechanical ventilation including invasive aspergillosis

Brief summary: To observe changes of circulating and tissue dendritic cells in acute lung injury,including invasive aspergillosis pneumonia

Detailed description: Change of circulating and tissular dendritic cells of patients with acute lung injury was still unclear, we used a flow cytometry-based assay to quantify circulating and tissular DCs and their HLA-DR surface expression at the time of diagnosis and during the first week of evolution in patients with acute lung injury, and healthy people as controls.

Eligibility criteria: Inclusion Criteria:

* Sepsis induced acute lung injury

Exclusion Criteria:

* Younger than 18-year-old
* Pregnancy
* Cancer or organ transplant
* Asthma
* COPD
* Heart Failure

Primary outcomes:
measure: 28-day mortality
timeFrame: 28day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Haibo Qiu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02911493: Reducing Sedentary Time in Patients With Heart Failure
Official title: Reducing Sedentary Time in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: sedentary time
number of steps/day
mobility
disability
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2016-09-22
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the change in sedentary time and number of steps/day for older patients with heart failure at risk for mobility disability who receive a program to decrease sedentary behavior versus a standard program to increase exercise.


Eligibility criteria: Inclusion Criteria:

* NYHA II-IV,
* Age ≥ 65,
* SPPB score of \> 4 and ≤ 10 of 12,

  * and deemed (by 1° cardiologist) to be at maximal tolerated dose of heart failure medication (ACE-inhibitor (ACE-I)/angiotensin receptor blocker and beta blocker (BB) for patients with HF with reduced ejection fraction (HFrEF), and
  * blood pressure controlled for HF with preserved ejection fraction (HFpEF) according to the American Heart Failure Association HF guidelines.

Exclusion Criteria:

* Patients requiring medication titration such as ACE-I or BB, (will return to their cardiologist and be eligible after 3 months of stable medication.)
* Oxygen dependent lung disease,
* Orthopedic or neurologic disease that severely limits mobility,
* Active cancer diagnosis except non-melanoma skin cancer,
* Geriatric Depression Scale (GDS) score of ≥ 9 ,
* Limited life-expectancy of \<6 months,
* Known dementia or disease that effects ability to learn/follow directions, or
* Failed MiniCog test.

Primary outcomes:
measure: Number of Subjects that are more active than Control.
timeFrame: Monthly for 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado University
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Rebecca Boxer, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: