louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02518100: Vital Signs Patch: Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
Official title: Vital Signs Patch: Early Feasibility and Usability Study - Feasibility Study for Automated Monitoring of Vital Signs Measurements in the In-Patient Hospital Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Automated Measurement of Vital Signs
Lead sponsor: LifeWatch Services, Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This feasibility study evaluates the use of the Vital Signs Patch (VSP) System to take and monitor specified vital signs. It will be used in parallel with the normal equipment the study site uses to take and monitor vital signs.

Detailed description: To assess the feasibility and usability of the total Vital Signs Patch (VSP) System in an actual hospital environment on in-patients by monitoring specified vital signs. The VSP System will be assessed for incorporation into the study site's Information Technology infrastructure. The VSP measurements will be compared with the predetermined expected results of the established vital signs equipment normally used by the facility based upon clinician protocols.

The VSP System can take and monitor patient vital signs in a more reliable and consistent manner by removing the human variability that occurs when clinicians manually take a patient's vital signs. The VSP has been designed to automatically take and monitor the following vital signs:

* Arterial blood oxygen Saturation (SpO2)
* ECG (up to 3 - Lead)
* Heart Rate (Part of ECG)
* Surface Temperature
* Respiration

Eligibility criteria: Inclusion Criteria:

* Adult male and female hospital in-patients
* Vital signs considered 'stable' by clinical caregivers

Exclusion Criteria:

* Pediatric patients
* Female patients who are pregnant
* Patients with internal or external defibrillators
* Patients who have undergone surgery and still have a fresh incision on the chest
* Patients with skin damage on the chest such as burns, irritation, infections, wounds, etc.
* Patients who are in the Critical Care Unit (CCU)
* Patients who otherwise satisfy any of the contraindications associated with the VSP system.

Primary outcomes:
measure: Composite Outcome Measure - Successful Vital Signs Acquisition
timeFrame: Up to Four Days
Secondary outcomes:
measure: Adhesion
timeFrame: Up to Four Days
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Daniel J Cantillon, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00783900: Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
Official title: Intravenous Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atrial Fibrillation
Biatrial Pacing
Metoprolol
Keywords: Prevention
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Oulu University Hospital
name: Hospital Cordia, Kuopio, Finland
First posted: 2008-11-02
Enrollment: 316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery


Eligibility criteria: Inclusion Criteria:

* elective CABG and aortic valve cardiac patients,
* previous use of beta blocker

Exclusion Criteria:

* Previous episodes of Atrial fibrillation or flutter,
* II or II degree atrioventricular block, uncontrolled heart failure
* Sick sinus syndrome

Primary outcomes:
measure: biatriac pacing
timeFrame: 48 hours
measure: Incidence of atrial fibrillation
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Halonen Jari
Study officials:
References:
Clinical trial NCT00761800: Dermacyd Teen Care Tangerina Mix - Compatibility
Official title: Study for Dermatological Evaluation of Topic Compatibility (Primary and Accumulated Dermal Irritability, Dermal Sensitivity) of Dermacyd Teen Care Tangerina Mix .
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hygiene
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to demonstrate the absence of irritation potential (primary dermal irritability and cumulated dermal irritability) and allergy (sensibilization) of the product Dermacyd Teen Care Tangerina Mix.


Eligibility criteria: Inclusion Criteria:

* Phototype Skin I,II, III e IV
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation
* Use of Anti-inflammatory and/or immuno-Supression drugs 1 month before the study
* Personal history of atopy
* History of sensitivity or irritation for topic products
* Active cutaneous disease
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: The absence of primary and accumulated dermal irritability will be evaluated using International Contact Dermatitis Research Group (ICDRG) scale.
timeFrame: Throughout the study
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Jaderson Lima
role: STUDY_DIRECTOR
References:
Clinical trial NCT05474300: Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.
Official title: Retrospective Evaluation of the Effect of Slope Time in PCV Mode on Mechanical Power Calculation and Oxygenation in Covid-19 ARDS Patients.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19 Pneumonia
COVID-19 Acute Respiratory Distress Syndrome
Keywords: Tslope
Pressure controlled ventilation
mechanical ventilation
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2022-07-26
Enrollment: 40
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: Adult patients with Covid-19 ARDS diagnosis which has been admitted to intensive care unit, intubated and are on PCV mode on mechanical ventilation support will be included in the study.

Brief summary: The investigators are planning to investigate the effect of each 5% slope time change on mechanical power and SPO2 of the patients with Covid 19 ARDS diagnosis which are on mechanical ventilation PCV mode support.

Detailed description: In this study, with inspiration/expiration 1:2 and 1:1 time ratios in pressure controlled ventilation mode with different slope times mechanical power will be calculated in covid ARDS patients. In this way, the effect of every 5% slope time change in PCV on mechanical power and SPO2 will be investigated.

Eligibility criteria: Inclusion Criteria:

* adult patients with Covid-19 Acute Respiratory Distress Syndrome (ARDS) diagnosis
* intubated Covid-19 ARDS patients
* Covid-19 ARDS patients on mechanical ventilator support

Exclusion Criteria:

* heart failure disease
* Chronic Obstructive Pulmonary Disease (COPD)
* hemodynamically unstable patients
* pregnancy

Primary outcomes:
measure: mechanical power
timeFrame: 100 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bakırköy Dr sadi konuk Education hospital
Study officials:
affiliation: intensive care supspecialist
name: sinan asar, M.D
role: STUDY_DIRECTOR
References:
citation: Becher T, van der Staay M. Calculation of mechanical power for pressure-controlled ventilation: author's reply. Intensive Care Med. 2019 Oct;45(10):1498-1499. doi: 10.1007/s00134-019-05742-7. Epub 2019 Aug 20. No abstract available.
citation: Trinkle CA, Broaddus RN, Sturgill JL, Waters CM, Morris PE. Simple, accurate calculation of mechanical power in pressure controlled ventilation (PCV). Intensive Care Med Exp. 2022 May 30;10(1):22. doi: 10.1186/s40635-022-00448-5.
Clinical trial NCT06913400: Progression of Stereopsis Recovery in Strabismic Patients: A One-Month and Three-Month Post-Surgery Evaluation
Official title: Progression of Stereopsis Recovery in Strabismic Patients: A One-Month and Three-Month Post-Surgery Evaluation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Strabismic Amblyopia, Bilateral
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 34
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes.

Brief summary: This prospective longitudinal observational study aims to assess stereopsis recovery in strabismic patients at one month and three months post-corrective surgery. The study will be conducted at Mayo Hospital, Lahore, and Sajjad Eye Center, Burewala, with a sample size of 34 using a purposive sampling technique. Eligible participants include patients aged ≥5 years undergoing strabismus surgery for esotropia, exotropia, or vertical deviations, with best-corrected visual acuity (BCVA) of 6/12 in both eyes. Patients with previous strabismus surgery, amblyopia, neurological conditions, or sensory strabismus will be excluded.

Detailed description: Baseline assessments include visual acuity (Snellen Chart), ocular alignment (cover-uncover and prism cover tests), and stereopsis (Titmus Fly Test). The same tests will be repeated one month and three months post-surgery to evaluate changes. The study aims to determine whether strabismus surgery enhances binocular function and stereopsis, helping guide future treatment strategies. Data will be analyzed using paired t-tests to assess differences over time.

Eligibility criteria: Inclusion Criteria:

* Patients (≥5 years and adults) undergoing strabismus surgery for: esotropia, exotropia, vertical deviations (hypertropia or hypotropia)
* Best corrected visual acuity (BCVA) of 6/12 in both eyes
* Willingness to attend follow-up visits at 1 month and 3 months post-surgery.8

Exclusion Criteria:

* History of previous strabismus surgery
* Amblyopia
* Neurological and systemic conditions affecting vision
* Uncontrolled nystagmus and sensory strabismus
* Patients unable to complete stereopsis testing due to cognitive or physical limit

Primary outcomes:
measure: Titmus fly test
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: CENUM Center Mayo Hospital Rd, Anarkali Bazaar
state: Punjab
Study officials:
References:
Clinical trial NCT02858700: Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
Official title: Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Bacterial Infection
Keywords: neonatal bacterial infection
procalcitonin
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 550
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP), the pediatrician must make a difficult decision quickly or not to prescribe additional examinations and / or hospitalize or not the newborn in order to administer parenteral antibiotics. This decision takes into account several contextual data, (clinical, biological and bacteriological clinical data) to be considered simultaneously. These information lack sensitivity and specificity.

Therefore, the common attitude among newborns in many countries remains the achievement of a significant number of additional tests and the establishment, without a prior evidence of infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization. However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:

1. one source to higher health care costs (hospitalization, additional examinations)
2. Selection of the bacterial ecology of the newborn and neonatal services and
3. stress for the newborn and parents


Eligibility criteria: Inclusion Criteria:

* Birth to motherhood.
* Term \> 34 weeks .
* Presence of at least one of the factors of major or minor infection risk

Exclusion Criteria:

* cord blood sample unavailable.
* Death in the delivery room
* Corticosteroids prenatally (modification of cytokine production ) .

Primary outcomes:
measure: value of the procalcitonin in the umbilical cord blood
timeFrame: up to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
References:
Clinical trial NCT06076200: Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations
Official title: Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations With High Risk for EOS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Early-Onset Neonatal Sepsis
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Shandong Provincial Hospital
First posted: 2023-10-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research population of this study is pregnant individuals whose baby at high risk of developing early-onset sepsis after birth.

Brief summary: The purpose of this study is to describe the population pharmacokinetic characteristics of piperacillin/tazobactam after intravenous administration in pregnant women during pregnancy and delivery, and to evaluate pharmacodynamic effectiveness and safety of piperacillin/tazobactam in pregnant women whose baby are at high risk of developing early-onset sepsis after birth.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old;
* Pregnant women whose baby are at high risk of developing early-onset sepsis after birth have indications to use preventive or therapeutic antibiotics, and the antibiotics used are PIP/TAZO；
* Patients and their families are fully aware of the research content and sign the informed consent form.

Exclusion Criteria:

* Intolerance or serious adverse reactions to antibiotic use;
* Patients who stopped using PIP/TAZO more than 24 hours before delivery;
* Receiving other systemic trial drugs;
* There are other factors that the researchers think are not suitable for inclusion

Primary outcomes:
measure: Clearance (L/h) of piperacillin/tazobactam
timeFrame: Through study completion, an average of 20 days.
measure: Volume of Distribution (L) of piperacillin/tazobactam
timeFrame: Through study completion, an average of 20 days.
Secondary outcomes:
measure: PD target attainment
timeFrame: Through study completion, an average of 20 days.
measure: Adverse events
timeFrame: Through study completion, an average of 20 days.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
Study officials:
affiliation: Shandong University
name: Wei Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05579600: Suicide Prevention for Justice Involved Managed Care Subscribers
Official title: Managed Care Updates of Subscriber Justice System Involvement for Suicide Prevention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide and Self-harm
Keywords: suicidal behavior
jail release
behavioral health providers
suicide training
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: Michigan State University
First posted: 2022-10-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to test the effects of two suicide prevention interventions for individuals released from jail. The main questions it aims to answer are: Does the use of Caring Contacts improve subscriber engagement with healthcare services while reducing suicide-related outcomes? and Will providing training and resources to behavioral health providers improve re-engagement with healthcare services for patients recently released from jail? Participants will include (1) subscribers of a managed care organization (MCO) and (2) behavioral health providers within the MCO system. Interventions include sending subscribers Caring Contacts letters for 6-months following jail release and providing resources and training to behavioral health providers to target healthcare re-engagement and suicide prevention.


Eligibility criteria: Inclusion Criteria:

* 18+ years old
* Behavioral health (BH) providers/staff employed at a CareSource BH agency

Exclusion Criteria:

* None

Primary outcomes:
measure: Suicide Attempt
timeFrame: 6-months
Secondary outcomes:
measure: All-cause injury and poisoning
timeFrame: 6-months
measure: Outpatient behavioral health service linkage
timeFrame: 18 months
measure: CareSource Member Services (CMS) line use
timeFrame: 6-months
measure: Inpatient and Emergency department mental health care visits
timeFrame: 6-months
Other outcomes:
measure: Number of arrests
timeFrame: 18 months
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Sarah Arias
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02060500: Cardiaplication: A Novel Antireflux Operation
Official title: Cardiaplication: A Prospective Observational Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Keywords: GERD
fundoplication
cardiaplication
reflux
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Children's Healthcare of Atlanta
First posted: 2014-02-12
Enrollment: 8
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Gastro-Esophageal Reflux is a commonly encountered problem in infants. After failure of medical therapy, many children are referred for surgical intervention. Techniques have evolved over the last 50 years; however, benefits in children remain the center of debate in many surgical forums. This is primarily owing to the high incidence of recurrence of reflux and need for revisions later in life. Some clinicians theorize that the pathophysiology of reflux in infants is different from that of the population at large, and that the traditional operation may not be the best suited for this patient population. We propose a study to test an alternative plication technique for modifying the gastro-esophageal junction at the Angle of Hiss. By plicating the cardia of the stomach, we hypothesize that we will create a valve which will limit reflux without disrupting the diaphragmatic crura, thus reducing the incidence of recurrent hiatal hernia and limiting the incidence of fundoplications which are too tight.


Eligibility criteria: Inclusion Criteria:

* Patients under 12 months old who are scheduled to undergo an operative intervention for medically refractory GERD.

Exclusion Criteria:

* Inability to obtain consent
* Surgeon preference

Primary outcomes:
measure: Determine pH impedance probe results of Cardiaplication
timeFrame: At 3 months post-operatively
Secondary outcomes:
measure: Validate elongation of the intra-abdominal esophagus as a mechanism for "outgrowing" GERD in infants
timeFrame: 1 year post-op
Other outcomes:
Locations:
Study officials:
References: