louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01252147: Inter-rater and Intra-rater Reliability Study of the Global Eyelash Assessment Scale for Assessment of Overall Eyelash Prominence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 68
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Japanese adults

Brief summary: This study will evaluate the inter-rater and intra-rater reliability of the Global Eyelash Assessment (GEA) scale with photonumeric guide in Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Able and willing to remove all eye makeup and facial jewelry during study

Exclusion Criteria:

* Permanent eyelid makeup or eyelash implants of any kind
* Eyelash tint or dye application within 2 months
* Eyelash extensions within 3 months

Primary outcomes:
measure: Overall Inter-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1
timeFrame: Day 1
measure: Overall Intra-Rater Reliability of Assessing Overall Eyelash Prominence Using the Japanese Global Eyelash Assessment Scale (GEA-J) at Day 1
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Ueno
country: Japan
state: Tokyo
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02392247: Hemosonics- VCU Cardiac Surgery Clinical Study
Official title: Hemosonics- VCU Cardiac Surgery Clinical Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiopulmonary Bypass
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: HemoSonics LLC
First posted: 2015-03-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants for this study will be recruited at the Virginia Commonwealth University Medical Center. The subject population will be representative of the local racial and ethnic population.

Brief summary: This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

Detailed description: HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the Virginia Commonwealth University Medical Center and will involve patients undergoing cardiac surgery requiring bypass.

Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for cardiac surgery involving bypass circuit
* Subject is older than 18 years
* Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
* Patients on emergency cases

Primary outcomes:
measure: Clot Time
timeFrame: 1 day
measure: Clot Stiffness
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Bruce Speiss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04318847: Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial
Official title: Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vomiting in Infants and/or Children
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2020-03-24
Enrollment: 220
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial is intended to evaluate the efficacy and safety of the administration of ondansetron in children with mild-moderate dehydration.

The target population will be children between 4 and 13 years old who present vomiting.


Eligibility criteria: Inclusion Criteria:

* Presence of at least 2 vomits in the last 4 hours.
* Negative tolerance test.
* Signature of the informed consent by the parents or legal guardians.
* Diagnosis of vomiting or diagnosis of acute gastroenteritis with vomiting.
* Patients weighing 15 kg or more.

Exclusion Criteria:

* Altered conciousness.
* Sospected acute abdomen (appendicitis, invaginations...).
* Suspicion or presence of obstructive disease.
* Known severe digestive disease (Chron´s disease, ulcerative colitis...).
* Suspected food poisoning.
* Allergy to any of the drugs used in the study.
* Severe dehydration.
* Bilious vomiting.
* Previous abdominal surgery.
* Pathology that may affective degree of hydration of the patient (kidney failure, hypoalbuminemia..).
* Admission requirement or intravenous rehydration for any reason.
* Concomitant use of apomorphine.
* In relation to the possible lengthening of the QT, patients with problems of previous arrhythmia should be excluded or that they are receiving concomitant medication that can lengthen the QT, that have electrolyte disturbances.
* Patients receiving other serotonergic drugs.
* Patients who have undergone a previous adenotonsillectomy.
* Patients with hypocalcemia and/or hypomagnesemia.
* Patients with hereditary fructose intolerance.
* Diabetes patients.
* Lactose intolerant patients.
* Patients with indication of the low sodium diets.
* Hypersensitivity to ondansetron or other antagonists of the 5-HT3.

Primary outcomes:
measure: Percentage of children who return to medical/pediatric consultation for de same episode
timeFrame: An average of 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01072747: Efficacy And Safety Of Unfractionated Heparin In Patients With Cardiovascular Surgery Using Cardiopulmonary Bypass
Official title: Randomized, Blind and Comparative Clinical Trial of Efficacy and Security of Unfractioned Heparin Sodium of Bovine Origin in Patients Submitted to Cardiovascular Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prevention of Venous Thromboembolism
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2010-02-22
Enrollment: 104
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: The primary objective of this study is to verify, through a randomized, blinded, parallel clinical trial, the efficacy of bovine heparin from Bergamo Laboratory ACTIPARIN ® product when compared to porcine heparin APP Pharmaceutical in patients undergoing surgery cardiovascular disease and who require cardiopulmonary bypass, through the control of hemostasis during and after surgery, based on measurements of markers of coagulation ACT, aPTT, anti-Xa heparin levels and the excessive blood loss (hemorrhage) after the end of surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who agree with all aspects of the study and sign the FICT;
* Patients of both sexes;
* Patients over the age of 18 years;
* Patients with indication for cardiac surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

* Patients with hematological disorders that compromise the surgical outcome (eg, myeloproliferative disorders, anemia, Hb \<11.0 g / dL, platelets \<100,000 mm3);
* Patients with disorders of hemostasis (INR\> 1.40) (APTTr\> 1.40);
* Patients with renal impairment (creatinine\> 1.50);
* Patients with deep hyperthermia;
* Liver disease (AST and ALT\> 2 times that of the reference value);
* Patients with a history of allergy to heparin or protamine;
* Patients with a history of heparin-induced thrombocytopenia;
* infection (eg endocarditis, septicemia and pneumonia);
* Reoperations;
* Use of antiplatelet agents (clopidogrel and ticlopidine) for less than 7 days;
* Use of aspirin for less than 5 days;
* Use of heparin, low molecular weight less than 24 hours;
* Use of unfractionated heparin for less than 12 hours.

Primary outcomes:
measure: Coagulometric parameters markers heparin activity: ACT, APTT and Anti - Xa
timeFrame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
Secondary outcomes:
measure: Value of the total dose of heparin used, the activity and adequate reversal with the use of protamine.
timeFrame: (T0) Pre heparintion; (T1) Top of extracorporeal; (T2) Intraoperative period; (T3) End bypass; (T4) Postoperative
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica Pesquisa e Desenvolvimento Ltda
state: SP
Study officials:
References:
Clinical trial NCT02088047: The Effects of ProFoveate on Reducing Self-Stimulating Behaviors
Official title: The Effects of ProFoveate on Reducing Self-Stimulating Behaviors in Children Diagnosed With Autism Spectrum Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorders
Normal Hearing
Normal Intelligence
Exhibit Self- Stimulating or Ritualistic Behaviors
Keywords: Autism
Self-Stimulating behaviors
Autism Spectrum Disorders
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2014-03-14
Enrollment: 4
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is designed to pilot an intervention technique to reduce the self-stimulating behaviors seen in individuals with autism spectrum disorders using intervention with ProFoveate pellets. Self-stimulating behaviors like hand flapping, eye blinking, and rocking, can interfere with the individual's ability to interact with their peers. Participants will wear the pellets for four week and measures with taken again. Another group of participants will not get the pellets. Both groups will be tested at the beginning and end of the study. Any variations in self-stimulating behaviors will be documented through parent report, Observational data. The investigators hypothesize that they will see changes in self- stimulating behaviors as a result of the strategic placement of the ProFoveate™ pellets on the ears of one group of the participants.


Eligibility criteria: Inclusion Criteria:

* Have a documented diagnosis of high functioning autism spectrum disorders (autism, Asperger's syndrome, or Pervasive Development Disorder (PDD) as reported by specialists who use the established criteria (American Psychiatric Association,2000)
* Pass a hearing screening at 25 decibels for the frequencies 1000, 2000 and 4000 hertz
* Score 85 or above on the Test of Nonverbal Intelligence- 4 (TONI-4; Brown, Sherbenou \& Johnsen, 2009)
* Exhibit noticeable self- stimulating or ritualistic behaviors (i.e., scratching, hand flapping, eye blinks, etc.) and/or visual characteristics of Autism Spectrum Disorder (ASD) (sensitivity to light, visual fixations, poor eye contact, etc.) as reported by parents and/or observed on videos taken during assessment.

Exclusion Criteria:

* Known history of latex allergy
* Intelligence Score below 85
* Fail the hearing screening

Primary outcomes:
measure: Numbers of Self-stimulating Behaviors
timeFrame: Baseline to 4 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas at Little Rock Speech and Hearing Clinic
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Samuel Atcherson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01413347: The Method to Reduce Displacement of Double-lumen Tube
Official title: The Method to Reduce Displacement of Double-lumen Tube During Patient Positioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Double-lumen Tube Displacement
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 devise the method to reduce displacement of a left-sided double-lumen tube during patient positioning.


Eligibility criteria: Inclusion Criteria:

* patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes

Exclusion Criteria:

* intraluminal lesion of left bronchus
* very distorted anatomy of tracheobronchial tree

Primary outcomes:
measure: tracheal displacement
timeFrame: up to 5 minutes
Secondary outcomes:
measure: bronchial displacement
timeFrame: up to 5 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Seo JH, Hong DM, Lee JM, Chung EJ, Bahk JH. Double-lumen tube placement with the patient in the supine position without a headrest minimizes displacement during lateral positioning. Can J Anaesth. 2012 May;59(5):437-41. doi: 10.1007/s12630-012-9679-7. Epub 2012 Feb 25.
Clinical trial NCT05009147: Home-based Massage by Caregivers for Dementia
Official title: Effects of Manual Massage on Improving Behavioral and Psychological Symptoms of Dementia and Sense of Burden Among Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Massage
Burden
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to investigate the effects of manual massage on improving behavioral and psychological symptoms of dementia and sense of burden among caregivers.

Detailed description: A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.

Eligibility criteria: Inclusion Criteria:

* Over 65 years old, diagnosed with dementia, agitation or depression, irregular massage and exercise habits.

Exclusion Criteria:

* Those who have open wounds, inflammation, infection, burns and scalds, artificial blood vessels in the hands, or diagnosed as inappropriate for massage in the near future, the severity of symptoms affects the study participants.

Primary outcomes:
measure: change agitation
timeFrame: before , during and after 8-weeks massage training interventions
measure: change depression
timeFrame: before , during and after 8-weeks massage training interventions
measure: change stress
timeFrame: before , during and after 8-weeks massage training interventions
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taipei University of Nursing and Health Sciences
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Chen-Yi Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02760147: BEACON Care ® System Assisting Ventilation in Pressure Support Ventilation (PSV) Patient
Official title: Evaluation of Beacon Care System Advice in Pressure Support: Does the System Maintain Patients Within Appropriate Levels of Support?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Artificial Respiration
Keywords: Pressure Support Ventilation
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2016-05-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the ventilator settings advice given by the BEACON care system in fitting with best level of support in patient under mechanical ventilation in Pressure Support mode.

Detailed description: The purpose of this study is to evaluate whether pressure support settings suggested by the B3 system and pressure support as well as Positive End Expiratory Pressure (PEEP) settings suggested by the B5 system, i.e. balancing under and over support based upon physiological models and simple clinical measures, are consistent with keeping patients within appropriate levels of support as assessed by the ratio between airwaiy pressure generated by the respiratory muscles (Pmus) and the maximum inspiratory pressure (MIP) (Pmus/MIP), the ratio between the inspiratory time (TI) and total respiratory time (TTOT) (TI/TTOT) and the Tension-Time index (TTi), these being obtained using less frequently used esophageal catheter measurements.

Eligibility criteria: Inclusion Criteria:

* Under mechanical ventilation in Pressure Support mode

Exclusion Criteria:

* Neuromuscular impairment

Primary outcomes:
measure: Reduction of respiratory fatigue of patient under mechanical ventilation
timeFrame: Average of 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Azienda Ospedaliero Universitaria Sant'Anna
Study officials:
affiliation: Aalborg University
name: Stephen Rees, Medical
role: STUDY_DIRECTOR
affiliation: Aalborg University
name: Dan Stieper Karbing, Engenieer
role: PRINCIPAL_INVESTIGATOR
affiliation: Ferrara University
name: Savino Spadaro, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Ferrara University
name: Carlo Alberto Volta, Medicine
role: STUDY_DIRECTOR
References:
Clinical trial NCT06755047: 3D Placental Volume in Placenta Accreta
Official title: 3D Ultrasound Placental Volume and Vascular Indices Versus 2D Parameters for Diagnosis of Placenta Accreta Spectrum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Placenta Accreta
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 38
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with placenta previa from 24 -39 weeks will be counselled to participate in the study. Patients will be enrolled in one of the 2 groups. Group 1, 3D Ultrasound with placental volume and vascular indices will be calculated. Group 2 , 2D ultrasound parameters and color Doppler study will be performed.

Brief summary: Placenta Accreta spectrum is a major obstetric disease nowadays. Different methods are used for antenatal diagnosis. In our study, investigators are aiming to compare 2 common ways for diagnosis, i.e; 3D Ultrasound and 2D with color Doppler.

Detailed description: The word placenta accreta spectrum disorders (PASD) implies an atypical implantation of the placenta into the uterine wall and has been used to express placenta accreta, increta and percreta. Placenta accreta is a placenta where the placental villi sick on directly to the myometrium. Placenta increta is a placenta where the placental villi attack into the myometrium and placenta percreta is a placenta where the villi invade through the myometrium and into serosa. No antenatal diagnostic method gives the clinician 100% assurance of either ruling in or ruling out the existence of placenta accreta. The definitive diagnosis of placental accreta spectrum is frequently ended postpartum on hysterectomy specimens when an area of accretion shows chorionic villi which make direct contact with the myometrium and absence of deciduae. Antenatal ultrasound is the method of choice used to establish the diagnosis and direct clinical management.The combined use of power Doppler with three dimensional (3D) ultrasound provides the possibility of quantifying moving blood within a volume of interest. Three indices are calculated, namely vascularization index (VI), flow index and vascularization flow index

Eligibility criteria: Inclusion Criteria:

* pregnant women with placenta previa

Exclusion Criteria:

* congenital anomalies of placenta Placental separation Uterine anomalies

Primary outcomes:
measure: Vascular index
timeFrame: 1 months
Secondary outcomes:
measure: 2D ultrasound
timeFrame: 1 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
References: