louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02726321: Autonomic Testing in Subclinical Carotid Atherosclerosis
Official title: Early Detection of Subclinical Carotid Atherosclerosis Through Autonomic Testing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subclinical Carotid Atherosclerosis
Lead sponsor: Universidade Camilo Castelo Branco
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects referred to the Heart Institute of Santa Casa Charity (IACOR), Fernandopolis, Brazil for noninvasive carotid artery duplex ultrasonography. Carotid arteriosclerotic disease is evaluated through measuring the IMT and calculating the plaque score.

Brief summary: Background: Atherosclerotic carotid intima-media thickness (IMT) may be associated with alterations in the sensitivity of carotid and subclavian baroreceptors.

Aim: The aim of this study is to investigate if carotid IMT is associated with changes in the autonomic modulation of the heart rate variability (HRV).

Methods: This is a prospective cross-sectional study. The carotid IMT is determined by B-mode and duplex ultrasonography. The cardiovagal function was determined through linear and nonlinear measures of HRV. Linear regression models, adjusted for demographics, comorbidities, body mass index, waist-hip-ratio, and left ventricular ejection fraction will be used to evaluate the association between HRV parameters and carotid IMT.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic patients aged 18 years and older without a history of transient ischemic attack, stroke, or other neurologic signs or symptoms are selected to participate in the study.

Exclusion Criteria:

* Patients with symptomatic carotid artery stenosis were excluded if the patient had transient or permanent focal neurologic symptoms related to the ipsilateral retina or the cerebral hemisphere.
* Patients with heart rhythm disorders, pacemaker, heart failure, ejection fraction less than 0.45, chronic renal failure on hemodialysis, severe liver failure, myocardial infarction, endarterectomy, carotid angioplasty, carotid dissection and carotid occlusion were excluded.
* Patients receiving drugs known to interfere with autonomic function, such as beta-blockers, calcium channel blockers, angiotensin-converting enzyme inhibitors, vasodilators, statins, neuroleptics and nasal vasoconstrictors, were discontinued for 24 hours before the tests.

Primary outcomes:
measure: carotid intima-media thickness (IMT)
timeFrame: 1 day
measure: cardiovagal function
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Camilo Castelo Branco
name: Ovidiu C Baltatu, MD PhD
role: STUDY_CHAIR
affiliation: Heart Institute of Santa Casa Charity (IACOR) Fernandopolis
name: Valter L Pereira Jr., MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02553421: Optical Detection of Intravenous Infiltration:A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infiltration of Peripheral IV Therapy
Keywords: infiltration
extravasation
peripheral intravenous therapy
Lead sponsor: ivWatch, LLC
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 243
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.


Eligibility criteria: Inclusion Criteria:

* Signed consent and/or assent
* Newborn to 17 years of age
* Weight \> 2.5 kg

Exclusion Criteria:

* Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
* Severe scarring of tissue (excessive IV use)
* Tattoo in area of PIV site
* IV site located in antecubital fossa

Primary outcomes:
measure: Time Infiltration Detected by Nurse
timeFrame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
measure: Infiltration Sensitivity
timeFrame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
measure: Notification Rate of ivWatch Device
timeFrame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01822821: Pain Control After Cardiac Surgery Using Intravenous Acetaminophen
Official title: Intravenous Acetaminophen Analgesia After Cardiac Surgery: A Randomized, Blinded, Controlled Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Males or females
18 years of age or older.
Non-emergency
cardiac surgery
midline sternotomy.
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 150
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: OTHER

Brief summary: Evaluate the efficacy of IV acetaminophen; compared to a placebo, in reducing opioid consumption and/or pain intensity scores after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* - Males or females 18 years of age or older.
* Non-emergency cardiac surgery via a midline sternotomy at Cleveland Clinic Main Campus.

Exclusion Criteria:

1. Redo cardiac surgery.
2. Combined CABG (Coronary Artery Bypass Graft)\& valve replacement, multiple valve replacements, Ascending aortic or aortic arch surgery.
3. Weight \< 50 Kg or Body mass index \> 38 kg/m2.
4. Left ventricle EF ¡Ü 35% ,Right ventricular moderate or severe dysfunction.
5. Severe (3-4 +) Tricuspid Regurgitation.
6. Recent stroke (within 6 months).
7. Severe lung disease requiring home O2 therapy.
8. Preoperative renal insufficiency (Creatinine \> 2.0) or on dialysis.
9. History of liver cirrhosis or active liver disease.
10. Chronic pain conditions controlled by preoperative opioid administration.
11. Known allergy to acetaminophen or fentanyl.

Primary outcomes:
measure: Cumulative Opioid Consumption
timeFrame: End of surgery through 24 hours after surgery
measure: Pain Intensity
timeFrame: End of surgery through 24 hours after surgery
Secondary outcomes:
measure: Postoperative Nausea and Vomiting
timeFrame: End of surgery through 24 hours after surgery
measure: Postoperative Sedation
timeFrame: Measured at 8, 16, and 24 hours after surgery
measure: Duration of Mechanical Ventilation (Minutes)
timeFrame: End of surgery until the initial end of ventilation or date of death from any cause, whichever came first, assessed up to 1 week.
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: End of surgery through discharge from ICU
measure: Hospital Length of Stay
timeFrame: end of surgery through hospital discharge
measure: Alanine Aminotransferase (ALT); U/L
timeFrame: Two days after surgery or date of death from any cause, whichever came first
measure: Aspartate Aminotransferase (AST); U/L
timeFrame: Two days after surgery or date of death from any cause, whichever came first
measure: Total Bilirubin (mg/dL)
timeFrame: Measured at 1 day and 2 days after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Negmeldeen Mamoun, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01551121: Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes
Official title: Assessment of an Automated Telesurveillance System on the Incidence of Serious Falls in Nursing Homes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Elderly of 75 Years and Living in Nursing Homes
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2012-03-12
Enrollment: 216
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: old subject

Brief summary: 3 Nursing homes in the Limousin region will be equipped with the automated telesurveillance system. Patient will be selected by general practitioner and randomized into two groups after informed consent. One group will have cameras installed and the other will not and will act as a comparison group. Patient will be assessed three times during the study, at inclusion, 6 months and 12 months. Each assessment is composed of a standard geriatric assessment, a fall questionnaire, an autonomy scale (SMAF scale) and a quality of life questionnaire (EQ5D). Every falls will be considered as adverse events and will therefore be listed along the study and characterized in types and number.


Eligibility criteria: Inclusion Criteria:

* Patient aged more than 75 years old
* Patient living in Limoges or Gueret nursing home
* Patient informed consent and/or proxy consent
* Patient able to understand the study, respect its imperatives and able to do evaluations
* Patient able to stand up from the bed
* Patient covered by the French health insurance

Exclusion Criteria:

* Patient with a short term prognosis pathology
* In multiple bed rooms, if at least one patient does not agree with the trial

Primary outcomes:
measure: The impact of the automated telesurveillance system on the risk ratio of falls
timeFrame: one year
Secondary outcomes:
measure: The impact of the system on global risk of falling
timeFrame: 1 year
measure: The impact of the system on autonomy loss
timeFrame: 1 year
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University hospital
Study officials:
affiliation: University Hospital, Limoges
name: Thierry DANTOINE, MD
role: STUDY_DIRECTOR
affiliation: Gueret Hospital
name: Michel PAILLER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03229421: Dermatologic Manifestations of Zika Virus
Official title: Survey of Symptoms and Dermatologic Characterization Associated With Zika Virus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Zika Virus Symptoms and the Associated Exanthema
Keywords: Zika Virus
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Pontificia Universidad Catolica Madre y Maestra
First posted: 2017-07-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults 18 y/o with confirmed zika virus diagnosis

Brief summary: The purpose of this study is to determine whether any diagnostic patterns exist in the symptom presentation of Zika Virus.

Detailed description: The study has both retrospective and prospective components. The retrospective review includes medical records with laboratory confirmed Zika Virus diagnosis and the prospective component will enroll adults presenting with febrile illness and rash and ask them to complete a survey about their symptoms. Diagnostic testing will be completed to confirm infection source.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years and older presenting with febrile illness and rash

Exclusion Criteria:

* Patients aged 17 years or younger

Primary outcomes:
measure: Number of days with specific symptoms
timeFrame: 20 minutes
Secondary outcomes:
measure: Frequency measures of initial clinical presentations
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Santo Domingo
country: Dominican Republic
facility: Pontificia Universidad Catolica Madre y Maestra, Departamento de Medicina
state: Illinois
Study officials:
affiliation: Northwestern University
name: Roopal V. Kundu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05232721: Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
Official title: Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 275
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who use the new instrument for Fecal Immunochemical Test.

Brief summary: Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .

Detailed description: Colorectal cancer (CRC) is the third most common cancer worldwide and has become a progressively important public health problem that inevitably leads to an increase in morbidity and medical costs. Therefore, many countries have a screening program in place to lower the incidence of CRC. Subjects with a positive fecal immunochemical test (FIT) have a much higher likelihood of advanced neoplasms than the general population.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal immunochemical test (FIT).

Eligibility criteria: Inclusion Criteria:

* People who use the new instrument for fecal immunochemical test(FIT)
* People sign an "informed consent form"

Exclusion Criteria:

* People with history of surgery in any part of the large bowel;
* People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);

Primary outcomes:
measure: Diagnostic performance of advanced neoplasms
timeFrame: 4 months
Secondary outcomes:
measure: Diagnostic performance of Colorectal Cancer
timeFrame: 4 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Li yanqing, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06612021: Hema Free Versus Hema Containing Adhesives in Posterior Restorations
Official title: Clinical Performance of Posterior Restorations Using Hema Free Universal Adhesive Versus Hema Containing Universal Adhesive Over One Year Using USPHS Criteria: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Dental Caries
Keywords: HEMA free
HEMA containing adhesive
Giomers
Giomer
USPHS criteria
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-09-25
Enrollment: 64
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of study is to evaluate the clinical performance of posterior restorations using HEMA free universal adhesive versus HEMA containing universal adhesive over one year using USPHS criteria.

Detailed description: The study is intended to evaluate the HEMA free universal adhesive versus HEMA containing universal adhesive when both used in conjunction with giomer aesthetic restorations in occlusal cavities in posterior teeth ICDAS III and IV.

The restorations will be evaluated at baseline, 6 and 12 months according to modified USPHS criteria in terms of marginal staining, marginal adaptation and caries recurrence.

Patients will be recruited from outpatient clinic of conservative dentistry department, cairo university according to inclusion and exclusion criteria. patient will be randomly allocated to intervention or control group.

Eligibility criteria: Inclusion Criteria of participants:

* Patients with occlusal caries in molars classified as ICDAS III or IV.
* 19-35 years.
* Males or Females.
* Co-operative patients approving to participate in the trial.

Exclusion criteria of participants:

* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Allergic history concerning methacrylate.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or tempromandibular joint disorders.

Primary outcomes:
measure: marginal staining of restoration
timeFrame: baseline ,6 months &amp; 12 months
Secondary outcomes:
measure: caries recurrence
timeFrame: baseline ,6 months ,12 months
measure: marginal adaptation of restoration
timeFrame: baseline ,6 months and 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry Cairo university
state: Manyal
Study officials:
affiliation: lecturer of conservative dentistry, Cairo university
name: Alaa F Abdelsalam, phD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of conservative dentistry, Cairo university
name: Hadier M Gad, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of conservative dentistry, Cairo University
name: Manar A Elmokanen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00334321: Pelvic IMRT With Tomotherapy in Post-Hysterectomy Endometrial Cancer Patients
Official title: Pelvic IMRT With Tomotherapy: A Phase I Feasibility Study in Post-Hysterectomy Endometrial Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endometrial Cancer
Keywords: IMRT
Tomotherapy
Post-Hysterectomy
Endometrial Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2006-06-07
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is evaluating the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.


Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years of age
2. Karnofsky Performance Status of greater than or equal to 60
3. FIGO Surgical Stage I, II, and III
4. Pathologic confirmation of endometrial cancer
5. Patient status post hysterectomy
6. Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
7. Patients must have adequate:

   * Bone Marrow Function:

     * ANC ≥ 1,500/mcl (\< CTCAE v 3.0 Grade 1).
     * Platelets ≥ 100,000/mcl (\< CTCAE v3.0 Grade 1).
   * Renal Function:

     * Serum creatinine ≤ institutional upper limit normal (ULN) (CTCAE v 3.0 Grade 0). Note: if serum creatinine \> ULN, a 24-hour creatinine clearance must be collected and must be \> 50 mL/min.
   * Hepatic Function:

     * Bilirubin ≤ 1.5 x ULN (\< CTCAE v 3.0 Grade 1).
     * SGOT≤ 2.5 x ULN (\< CTCAE v 3.0 Grade 1).
     * Alkaline phosphatase ≤ 2.5 x ULN (\< CTCAE v 3.0 Grade 1).
   * Neurologic Function:

     * Neuropathy (sensory and motor) \< CTCAE v 3.0 Grade 1.

Exclusion Criteria:

1. Age less than 18 years of age
2. Karnofsky Performance Status less than 60
3. Radiographic or pathologic evidence of metastatic disease (other than pelvic or para-aortic lymph nodes)
4. Prior pelvic radiation therapy

Primary outcomes:
measure: The study will evaluate the feasibility of using helical tomotherapy to deliver IMRT in post-hysterectomy endometrial cancer patients receiving adjuvant radiotherapy.
timeFrame: 1 year from the start of radiation therapy.
Secondary outcomes:
measure: Evaluate incidence of early toxicities
timeFrame: 30 days after last day of radiation therapy
measure: Evaluate incidence of late toxicities
timeFrame: 1 year from the start of radiation therapy
measure: Evaluate local, regional, and distant recurrence rates
timeFrame: 5 years from start of radiation therapy
measure: Evaluate 5-year disease-free and 5-year overall survival rates
timeFrame: 5 years from start of radiation therapy
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Perry W Grigsby, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01218321: The Effect of Anti-epileptic Drugs on Mitochondrial Activity
Official title: Phase 1 Study for Measuring the Effect of Antiepileptic Drugs on Mitochondrial Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: antiepileptic drugs
mitochondria
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children, ages 3 to 18 years old who start new antiepileptic drug treatment for the first time for new onset epilepsy

Brief summary: This study is based on the hypothesis that antiepileptic drugs (other than Valproic acid) have an effect on the mitochondrial oxidative phosphorylation.

The objective of this study is to evaluate this effect in an accessible tissue-human peripheral white blood cells.

Detailed description: Antiepileptic drugs adverse reactions, including hepatotoxicity, are rare but potentially fatal, especially among children. Although the mechanism of the liver toxicity remains elusive, mitochondrial oxidative stress, has been hypothesized to play a role.

Most of the studies addressing antiepileptic drug effects on the mitochondria discuss the effect of valproic acid. The exact mechanisms involved in the drug-induced effects on oxidative phosphorylation are still far from being resolved. Most of the studies investigated the effect of valproic acid by using animal models or different in vitro methods.Mitochondrial diseases should be considered as a risk factor for valproic acid-induced hepatotoxicity, and there is a consensus for avoiding the administration of the drug for these patientsIs it possible that other antiepileptic drugs have similar effects? The knowledge regarding the effects of other antiepileptic drugs on the mitochondria is relatively scarce.

Eligibility criteria: Inclusion Criteria:

* Children between the ages of 3 and 18 years old, who suffer from new onset epilepsy as diagnosed by a certified pediatric neurologist, who do not suffer from a ''metabolic'' disorder, are treated by a single antiepileptic drug, and are not receiving any other type of medication on a chronic basis were included

Exclusion Criteria:

* Children younger than 3 years of age or older than 18 years of age, children who were suspected or known to suffer from a ''metabolic'' disorder or liver dysfunction, children who were under treatment, by any medication on a chronic basis, at the time of the study were excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
Study officials:
affiliation: Hadassah Medical Organization
name: Itai Berger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berger I, Segal I, Shmueli D, Saada A. The effect of antiepileptic drugs on mitochondrial activity: a pilot study. J Child Neurol. 2010 May;25(5):541-5. doi: 10.1177/0883073809352888.