louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04586569: PIRA vs Standard Preoperative Education
Official title: A Pilot Randomized Control Trial Testing the Acceptability and Feasibility of a Pediatric Interactive Relational Agent (PIRA) vs. Standard Preoperative Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Anesthesia Emergence Delirium
Procedural Anxiety
Keywords: education
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Northeastern University
First posted: 2020-10-14
Enrollment: 74
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the feasibility and acceptability of enhanced preoperative education using a Pediatric Interactive Relational Agent (PIRA), designed for children ages 4 through10 years and their families, compared to the standard preoperative education currently provided. The study will also look at any differences in anxiety between the two educational groups.


Eligibility criteria: Inclusion Criteria:

* Parents (age 18+) and their children, ages 4 through 10 years old, who are undergoing general anesthesia and elective, outpatient ORL surgery at BCH Waltham
* American Society of Anesthesiology (ASA) physical status I or II
* Both parents and their children must be fluent in English

Exclusion Criteria:

* Parents without reliable internet access through a tablet or computer
* Parents of children with diagnosed developmental delays
* Parents who have children who have had previous surgical history under general anesthesia
* Parents of children involved in other anesthesia-related studies at BCH

Primary outcomes:
measure: Parental Utilization
timeFrame: 2-10 days
measure: Parental Perceived Impact and Impressions assessed through the Parental PIRA Survey
timeFrame: preoperative period - 1 day
Secondary outcomes:
measure: Child Anxiety in Preoperative Waiting using the Modified Yale Preoperative Anxiety Scale (mYPAS) for Child Anxiety
timeFrame: preoperative period - 1 day
measure: Parental Anxiety in Preoperative Waiting using the Parental State-Trait Anxiety Inventory (STAI) for Parental Anxiety
timeFrame: preoperative period- 1 day
measure: Emergence from Anesthesia: Presence or absence of emergence agitation/delirium (ED) using the PACU Pediatric Anesthesia Emergence Delirium (PAED) for Anesthesia scale
timeFrame: immediately postop - 1 day
Other outcomes:
Locations:
city: Waltham
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Linda Bulich
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310969: Clinical Effect of MiboFlo in Dry Eye Patients
Official title: Clinical Effect of MiboFlo in Dry Eye Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndromes
Meibomian Gland Dysfunction
Keywords: dry eye
meibomian gland dysfunction
therapy
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 90
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 aim of this prospective study is to compare the changes between the patients receiving traditional treatment and the patients with MiBoFlo, evaluating the effectiveness of MiBoFlo.

Detailed description: The MiBoFlo Thermoflo uses a proprietary thermoelectric heat pump to help meibum maximize liquefaction, improving the preservation and function of the tear film's evaporative component. It supplies continuous controlled heat to the outer skin of the eyelids, absorbing deep into the tissue and breaks down the hardened oils in the meibomian glands. We are trying to find a effective, safe and economical therapy for dry eye patients.

Eligibility criteria: Inclusion Criteria:

* 18 years of age of older;
* Meet the diagnostic criteria for dry eye developed by DEWS II: OSDI score≥15 points, TBUT≤10 minutes;
* Meet the signs of meibomian gland dysfunction

Exclusion Criteria:

* Had skin allergies or inflammation;
* Had active ocular infection or inflammation;
* Had history of ocular surgery, eyelid surgery or neurological paralysis within 6 months;
* Had history of systemic disease affecting ocular surface function, such as Stevens-Johnson syndrome, Sjögren syndrome etc.

Primary outcomes:
measure: subjective symptom score
timeFrame: 2 weeks
measure: Meibomian Glands Yielding Liquid Secretion (MGYLS)
timeFrame: 2 weeks
measure: Meibomian Glands Secretion (MGS)
timeFrame: 2 weeks
Secondary outcomes:
measure: Corneal Fluorescein Staining(CFS)
timeFrame: 2 weeks
measure: Tear Meniscus Height(TMH)
timeFrame: 2 weeks
measure: Non-invasive Keratograph Break-up Time(NIKBUT)
timeFrame: 2 weeks
measure: Meibography
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Ying Jie, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT02059369: Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
Official title: Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Recurrence
Keywords: Atrial fibrillation
Recurrence
CFAE
linear ablation
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 90
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: While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic persistent AF
* After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia

Exclusion Criteria:

* Left atrial thrombus

Primary outcomes:
measure: Freedom from atrial arrhythmia
timeFrame: 12 months
Secondary outcomes:
measure: Procedural and safety data
timeFrame: 12 months
measure: Number and result of reablation procedure
timeFrame: 12 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
Study officials:
References:
Clinical trial NCT00453869: Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail
Official title: Screening of Fibrosing and/or Viral Chronic Hepatopathies in Jail
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Fibrosis
Keywords: Liver fibrosis
Hepatitis B virus and C virus
FibroMeter
FibroScan®
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2007-03-29
Enrollment: 240
Sex: MALE
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: All subjects in jail who have a medical evaluation.

Brief summary: The prevalence of chronic hepatopathies is high in jail. However, the medical care of these hepatopathies is few developed. This study is an observational, an epidemiologic (screening and prevalence of fibrosing hepatopathies) and an evaluating study for a better taking care of these hepatopathies in jail. The aims of the study will be to evaluate the diagnostic performance of the FibroMeter score in the screening of the hepatic fibrosis in persons with multiple risk factors for liver fibrosis (alcoholism, intravenous drug users, tattoo, and virological status) with FibroScan® as gold standard; to evaluate the feasibility of these different screening tools for chronic hepatopathies in jail and to evaluate the prevalence of the fibrosing hepatopathies with clinically significant fibrosis and theirs risk factors, alcohol and hepatitis B and hepatitis C viruses in population from Angers jail.

Detailed description: Primary outcome: Screening of clinically significant fibrosis with FibroMeter blood score. Screening for hepatitis B and hepatitis C viruses.

Secondary outcome: Clinically significant fibrosis confirmed with FibroScan®.

The means for this study are a clinical questionnaire, a virological screening, a blood score for liver fibrosis: FibroMeter according to cause of the fibrosis and FibroScan® is referent and independent examination.

The expected results from this study are the knowledge of the prevalence of hepatopathies with hepatic fibrosis will be able to justify, possibly, a screening politic of them. This study will permit to evaluate the feasibility of noninvasive screening of the liver fibrosis in the goal to suppress the liver biopsy in a population having numerous drawbacks.

Eligibility criteria: Inclusion Criteria:

* Person over 18,
* All new inmates, for less than one month, in Angers jail,
* To have a written informed consent.

Exclusion Criteria:

* No consent obtained from person,
* Detention inferior to one month,
* Person under 18.

Primary outcomes:
measure: Liver fibrosis evaluation
timeFrame: D0
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital Angers
Study officials:
affiliation: UH Angers
name: Paul CALES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05071469: Comparison of Two Different Treatment Methods
Official title: Comparison of Short-term Effects of Two Different Treatment Methods in Patients With Subacromial Impingement Syndrome: a Randomized Controlled Single-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subacromial Impingement Syndrome
Musculoskeletal Diseases
Musculoskeletal Injury
Musculoskeletal Pain
Weakness, Muscle
Keywords: Subacromial Impingement Syndrome
Mulligan Mobilization Technique
Kinesiotaping
Physiotherapy
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: Muğla Sıtkı Koçman University
First posted: 2021-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: A number of previous studies investigated the effects of kinesiotaping (KT) in subacromial impingement syndrome (SIS).

Detailed description: Subacromial impingement syndrome (SIS) is characterized by shoulder pain that is exacerbated with especially arm elevation or overhead physical activities.

Eligibility criteria: Inclusion Criteria:

* Impingement symptoms in clinical tests
* Pain \>1 month

Exclusion Criteria:

* Any shoulder pathology.
* Have chronic systemic diseases or infections.
* History of any surgery shoulder complex.
* steroid injections and therapeutic approaches

Primary outcomes:
measure: Change of pain severity
timeFrame: Baseline- after 2 weeks (after treatment)
measure: Change of Range of Motion
timeFrame: Baseline- after 2 weeks (after treatment)
measure: Change of Functionality
timeFrame: Baseline- after 2 weeks (after treatment)
Secondary outcomes:
measure: Change of Sleep Quality
timeFrame: Baseline- after 2 weeks (after treatment)
measure: Change of Satisfaction of Life
timeFrame: Baseline- after 2 weeks (after treatment)
measure: Change of Satisfaction of Treatment
timeFrame: Baseline- after 2 weeks (after treatment)
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Muğla Sıtkı Koçman University
Study officials:
References:
Clinical trial NCT01484769: Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
Official title: Method Development and Assessment of the Effects of Tobacco Products on Oral Cavity Cells
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Squamous Cell Carcinoma
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults and minors diagnosed with squamous cell carcinoma of the head and neck that will undergo elective neck dissection surgery at either Norton Hospital, Kosair Children's Hospital, or University of Louisville Hospital.

Brief summary: Collection of tissues for analysis from patients undergoing elective neck dissection.

The hypothesis of the study is that specific genetic alterations occur in head and neck cancers that have spread to regional and/or distant sites, and these alterations can be identified from biopsy specimens to allow more accurate staging of tumor and better treatment planning.

Detailed description: The standard of care for the treatment of most squamous cell carcinoma of the head and neck is surgical extirpation of the primary tumor and elective neck dissection to remove regional nodes at risk for spread. Via this treatment regimen, the investigators will be able to prospectively obtain tissues for analysis from patients undergoing elective neck dissection.

The specific aims of this study are to compare gene expression between head and neck tumors with and without regional lymph node metastases, and to compare gene expression between head and neck tumor with and without distant metastases.

Eligibility criteria: Inclusion Criteria:

* All patients with biochemical evidence of squamous cell carcinoma of the head and neck.

Exclusion Criteria:

* Patients without biomedical evidence of squamous cell carcinoma.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: Norton Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References:
Clinical trial NCT04544969: Detecting Chemosensitivity and Predicting Treatmemt Efficacy With CTCs in mNPC
Official title: Detecting Chemosensitivity and Predicting Treatmemt Efficacy With Circulating Tumour Cells From Peripheral Blood in Metastatic Nasopharyngeal Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Circulating Tumor Cell
Nasopharyngeal Carcinoma
Distant Metastases.Clinical
Effects of Chemotherapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NPC patients with distant metastasis after 3 months of primary radiotherapy

Brief summary: The prospective observational clinical study will recruit 50 metastatic nasopharyngeal carcinoma (mNPC) patients, detecting patient's chemosensitivity with the circulating tumor cells (CTCs) from peripheral blood and prdicting patient's treatment efficacy with CTCs dynamic change.


Eligibility criteria: Inclusion Criteria:

* NPC patients with distant metastasis after 3 months of primary radiotherapy, and not suitable for local treatment
* At least having one measurable metastatic lesion
* All genders，range from 18～70 years old
* ECOG score 0 \~ 1
* Expected survival time ≥ 3 months
* White blood cell(WBC) count ≥ 3×109/L, neutrophile granulocyte(NE) count ≥ 1.5×109/L, hemoglobin(HGB) ≥ 90g/L, platelet(PLT) count ≥ 100×109/L
* Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) \< 2.5×upper limit of normal(ULN), bilirubin(BUN) or creatinine(CRE) \< 1.5×ULN, alanine aminotransferase (CCR) ≥ 60ml/min
* Inform consent form

Exclusion Criteria:

* Have or are suffering from other malignant tumors;
* Participating in other clinical trials;
* Drug or alcohol addition;
* Do not have full capacity for civil acts;
* Mental disorder;
* Pregnancy or lactation;
* Severe complication, eg, uncontrolled hypertension.

Primary outcomes:
measure: The coincidence rate between drug sensitivity test in CTCs and objective response rate
timeFrame: 6 months
Secondary outcomes:
measure: The changes of CTCs countings
timeFrame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
measure: Objective response rate
timeFrame: study period of 19 Months
measure: Progression free survival
timeFrame: baseline
measure: Cutoff value of CTC counts
timeFrame: Objective response at 6 months
measure: Predictive value of the changes of CTCs countings
timeFrame: Change from pre-chemotherapy to 22-28(±7) days after last course of chemotherapy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Chong Zhao, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06314269: Incidence of Perioperative Cerebrovascular Stroke in Assuit University Hospitals , Hospital Based Study
Official title: Incidence of Perioperative Cerebrovascular Stroke in Assuit University Hospitals , Hospital Based Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Perioperative Complication
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all Patients admitted to General surgery, cardiothorasic surgery and vascular surgery Depatments in assuit university hospitals during one year that will going to operation

Brief summary: Stroke is the most common cause of disability in elderly people (over 65years of age) and the third most common cause of death in the world . The World Health Organization estimates that one in six people globally will suffer from stroke in their lifetime.

Perioperative stroke is the most unwanted complication for patients, as well as for surgeons and anesthesiologists . The reported risk of perioperative stroke varies with the type of surgery. Its incidence is generally not high (approximate 0.1-1.9%) in non-cardiac, non-neurologic, and non-major surgery However, it may occur in up to 10% of patients undergoing high-risk cardiac or brain surgery . Patients with perioperative stroke are less likely to have a good functional outcome and have an eight-fold higher mortality compared with those without perioperative stroke


Eligibility criteria: Inclusion Criteria:

1. all Patients admitted to General surgery, cardiothorasic surgery and vascular surgery Depatments in assuit university hospitals during one year that will going to operation
2. ALL age Groups .
3. Both Sex.

Exclusion Criteria:

* Other surgical departments
* Patients with Syptoms that related to delayed recovery from anaesthesia .

Primary outcomes:
measure: 1- To determine incidence and prevalence of perioperative cerebrvosacular stroke in General surgery, cardiothorasic surgery and vascular surgery departments , Assuit university hospitalis , Egypt.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00981669: Rotavirus Vaccine Produced by Butantan Institute
Official title: Evaluation of Rotavirus Vaccine Produced by Butantan Institute. Phase I - Safety, Tolerability and Immunogenicity Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rotavirus Infections
Keywords: brazilian pentavalent rotavirus vaccine
safety
tolerability
immunogenicity
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
First posted: 2009-09-22
Enrollment: 80
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to describe the safety, tolerability and immunogenicity of the pentavalent rotavirus vaccine produced by Butantan Institute.

Detailed description: The Brazilian National Immunization Program (PNI) has introduced a oral monovalent vaccine against rotavirus for infants in its immunization schedule since 2006. Its introduction increased the Brazilian Ministry of Health budget because the vaccination in Brazil is free of charge. An agreement between Path Foundation and Butantan Institute has made possible the transfer of technology to Butantan Institute to produce, at a reduced cost, a pentavalent rotavirus vaccine including the the rotavirus serotypes more frequent in Brazil.

Eligibility criteria: Inclusion Criteria:

* Male healthy
* Age ≥18-40 years
* Not taking immunosuppressive drugs
* No clinical history of gastrointestinal diseases or surgeries
* No history of cardiac, neurologic, immunologic or endocrine diseases
* Normal eligibility laboratory tests
* To be willing to participate and sign the informed consent form
* No participation in another clinical trial in the past 6 months

Exclusion Criteria:

* Had received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment in this study

Primary outcomes:
measure: Number of Participants With Adverse Events.
timeFrame: Within the first five days post-vaccination.
Secondary outcomes:
measure: Anti-rotavirus IgA Level.
timeFrame: before each dose (total of doses:3) and after 6 weeks of the third dose
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto da Criança do Hospital das Clinicas da Faculade de Medicina da USP
Study officials:
affiliation: Butantan Institute
name: Alexander R Precioso, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Higashi HG, Luna E, Precioso AR, Vilela M, Kubrusly FS, Dias WO, Raw I. Acellular and "low" pertussis vaccines: adverse events and the role of mutations. Rev Inst Med Trop Sao Paulo. 2009 May-Jun;51(3):131-4. doi: 10.1590/s0036-46652009000300002.