louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01640886: Study of the Performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA
Official title: Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Bacteremia
Keywords: Staphylococcus aureus
methicillin resistant
MRSA
MSSA
Blood Culture
Diagnostic
Lead sponsor: MicroPhage, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-16
Enrollment: 764
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital patients with Gram positive blood cultures determined to be positive with the following bottle types:

1. bioMerieux BacT/Alert Standard Aerobic and Anaerobic
2. bioMerieux BacT/Alert FAN Aerobic and FAN Anaerobic

Brief summary: In vitro identification of S. aureus,methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)from positive blood culture using MicroPhage's bacteriophage-based diagnostic platform.

Detailed description: This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.

Eligibility criteria: Inclusion Criteria:

1. Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:

   * bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
   * bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic
2. Completion of the KeyPathTM BTA Test on the sample.
3. Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.

Exclusion Criteria:

1. Samples from blood culture positives over 24 hours from alarm
2. Samples deemed contaminated.
3. Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.

Primary outcomes:
measure: Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tuscon
country: United States
facility: University of Arizona, Infectious Disease Research
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Clinical Laboratory
state: California
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: MicroPhage, Inc.
name: Dipankar Manna, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04548986: Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)
Official title: Single-center Prospective Study to Validate the Performance of the Aktiia Optical Blood Pressure Monitoring (OBPM) Device at the Wrist Against Ambulatory Blood Pressure Monitoring (ABPM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Hypertension
Lead sponsor: Hopital Neuchatelois
Sponsor class: OTHER
Collaborators: name: Aktiia SA
First posted: 2020-09-16
Enrollment: 63
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study aims to assess the performances of optical blood pressure monitoring device, Aktiia.product in the context of cardiac rehabilitation program.


Eligibility criteria: Inclusion Criteria:

* Adult subjects (aged between 21 and 65)
* Subjects fluent in written and spoken French
* Subjects enrolled in a 12-weeks cardiac rehabilitation program
* Subjects agreeing to participate
* Subjects that have signed the informed consent form

Exclusion Criteria:

* Subjects with tachycardia (heart rate at rest \> 120bpm)
* Subjects with atrial fibrillation
* Subjects with severe heart failure (LVEF\<35%)
* Subjects with severe renal dysfunctions (eGFR \< 30mL/min/1.73 m2)
* Subjects with pheochromocytoma
* Subjects with Raynaud's disease
* Subjects with trembling and shivering
* Subjects with interarm systolic difference \> 15 mmHg
* Subjects with interarm diastolic difference \> 10 mmHg
* Subjects with arm paralysis
* Women in known pregnancy
* Subjects with an arteriovenous fistula
* Subjects with arm amputations
* Subjects with the upper arm circumference \> 64 cm
* Subjects with the wrist circumference \> 22 cm
* Subjects with the exfoliative skin diseases
* Subjects with lymphoedema

Primary outcomes:
measure: Mean absolute error for blood pressure
timeFrame: up to 24 hours
measure: Mean error for blood pressure
timeFrame: up to 24 hours
measure: Standard deviation of the error for blood pressure
timeFrame: up to 24 hours
measure: Mean absolute error for heart rate
timeFrame: up to 24 hours
measure: Mean error for heart rate
timeFrame: up to 24 hours
measure: Standard deviation of the error for heart rate
timeFrame: up to 24 hours
Secondary outcomes:
measure: Evaluation of the impact of ABPM induced stress on BP readings using inferential statistics.
timeFrame: 1 week
measure: Evaluation of patient's satisfaction for the two devices through a survey with multiple questions
timeFrame: up to 24 hours
measure: Assessment of the calibration stability of Aktiia OBPM algorithms
timeFrame: 12 weeks
measure: Assessment of systolic and diastolic blood pressure control during a 12 weeks cardiac rehabilitation program
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Neuchâtel
country: Switzerland
facility: Réseau Hospitalier Neuchâtelois
Study officials:
References:
Clinical trial NCT03784586: Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients
Official title: The Electrophysiological Study Guided ICD Strategy in Prevention of Arrhythmic Cardiac Death in Myotonic Dystrophy Type 1 Patients With Conduction System Disease (ACADEMY 1 Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myotonic Dystrophy 1
Sudden Cardiac Death
Keywords: Arrhythmias
electrophisiological study
primary prevention
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: MD1 patients with permanent pacing indication and needed of sudden cardiac death screening.

Brief summary: The aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy, including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in inducible patients, is able to improve survival in comparison with conventional therapy (CONV strategy) in Myotonic Dystrophy type 1 patients with conduction disorders.

Detailed description: Trial design:

This is a double-arm prospective observational study.

Patient population:

To be included in the study, DM1 patients had to have at least 18 years old, LVEF \>35% on two-dimensional echocardiography, permanent pacing indication after non-invasive electrocardiographic evaluation or invasive EPS evaluation, according to the current guidelines. The following exclusion criteria were applied: electrolyte imbalance, thyroid disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect cardiac conduction. All eligible DM1 patients underwent EPS for programmed ventricular stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent subsequently ICD implantation. Non-inducible DM1 patients did not receive an ICD and underwent pacemaker implantation.

Endpoints:

The primary endpoint was all-cause mortality. Secondary end-points were sudden death (SD), death due to cardiac arrhythmias, ICD interventions and arrhythmic events in implanted patients.

Eligibility criteria: Inclusion Criteria:

* MD1 diagnosis genetically confirmed
* LVEF \>35% on two-dimensional echocardiography
* Permanent pacing indication according to the current guidelines

Exclusion Criteria:

* Electrolyte imbalance
* Thyroid disorders
* Prior cardiac surgery
* Prior cardiac arrest
* Prior spontaneous sustained ventricular arrhythmias

Primary outcomes:
measure: Sudden Cardiac Death
timeFrame: 24 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 24 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Vincenzo Russo
Study officials:
References:
Clinical trial NCT00921063: A 5-Week Trial Of PD 0332334 And Alprazolam Extended Release Compared To Placebo In Patients With Generalized Anxiety Disorder
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, 5-Week Trial To Assess The Efficacy And Safety Of PD 0332334 Compared To Placebo And Alprazolam Extended-Release In Patients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-06-16
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 evaluate the safety and efficacy of PD 0332334 compared to placebo in the treatment of Generalized Anxiety Disorder in an adult population


Eligibility criteria: Inclusion Criteria:

* Healthy males or females with a diagnosis of Generalized Anxiety Disorder (GAD) (Diagnostic and Statistical Manual-IV \[DSM-IV\], 300.02).
* HAM-A Total Score ≥20 and item #1 on the HAM-D (depressed mood score) ≤2 at both Screening and Baseline/Randomization.

Exclusion Criteria:

* Current diagnoses (within the 6 months) of Major Depressive Disorder; Obsessive Compulsive Disorder; Panic Disorder; Posttraumatic Stress Disorder; Anorexia; Bulimia; Caffeine-induced anxiety disorder;
* Any of the following past or current diagnoses: Schizophrenia; Psychotic Disorder; Delirium, Dementia, Bipolar or Schizoaffective Disorder; Cyclothymic Disorder; Dissociative Disorders; Antisocial or borderline personality disorder
* Current use of psychotropic medications (i.e., drugs normally prescribed for depression, mania, anxiety, insomnia, or psychosis) that could not be discontinued 2 weeks prior to dosing.

Primary outcomes:
measure: HAM-A Total Score
timeFrame: 4 weeks
Secondary outcomes:
measure: HAM-A total score at week 1, 2 and 4
timeFrame: 1. 2. ands 4 weeks
measure: HAM-A somatic and psychic subscales
timeFrame: 1, 2, and 4 weeks
measure: HAM-A responders
timeFrame: 4 weeks
measure: HAM-A sustained responders
timeFrame: Week 1 through week 4
measure: DAS-A (daily assessment of symptoms of anxiety) and GA-VAS (VAS scale for global anxiety)
timeFrame: Day 2 through day 7
measure: CGI-I (Clinical Global Impression of Improvement) and PGI-I (Patient Global Impression of Change)
timeFrame: 1 and 4 weeks
measure: HAM-D total score
timeFrame: 1 and 4 weeks
measure: Sheehan Disability Score (SDS)
timeFrame: 4 weeks
measure: Treatment Satisfaction Questionaire for Medication
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01190163: Open Label Comparative Trial of Dinoprostone Plus or Minus Oxytocin Versus Oxytocin Alone in Cervical Ripening for Labor Induction
Official title: Phase IV, Multicenter, Open Label, Randomized Trial to Compare the Effectiveness and Safety of the Dinoprostone Vaginal Pessary vs. Oxytocin for Women Requiring Cervical Ripening Prior to Induction of Labor
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Vaginal Delivery
Cesarean Section
Keywords: Vaginal Birth delivery within 24 hours and C-section rate
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-08-27
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a comparative trial between oxytocin alone and dinoprostone for cervical ripening in unfavorable cervix pregnant women with 38 or more weeks of gestational age.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Gestational age ≥ 38 weeks
* Fetal cephalic presentation
* Bishop score \< 6

Exclusion Criteria:

* No uterine scar (no previous delivery by caesarean section)
* No more than 3 previous vaginal births
* No condition that disallows use of prostaglandins for induction of labor
* Premature rupture of the membranes
* Oligohydramnios

Primary outcomes:
measure: Vaginal birth delivery within 24 hours and C-section rate
timeFrame: 24 hours
Secondary outcomes:
measure: Treatment failure rate
timeFrame: 24 hours
measure: Uterine hyperstimulation and/or fetal distress
timeFrame: 24 hours
measure: Use of additional oxytocin
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
state: São Paulo
city: São Bernardo
country: Brazil
facility: Hospital Municipal Universitário - Faculdade de Medicina do ABC
state: São Paulo
city: São Paulo
country: Brazil
facility: Hospital M Boi Mirim
city: São Paulo
country: Brazil
facility: Hospital Maternidade Leonor Mendes de Barros
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT02670863: Safety and Efficacy Study
Official title: Safety and Efficacy of a New Term Infant Formula Supplemented With A Prebiotic: a Doubleblind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Term Birth
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-02-02
Enrollment: 239
Sex: ALL
Minimum age (years): 21
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

Detailed description: Randomized, double-blind, controlled interventional clinical trial design. The purpose of this study is to evaluate the safety and efficacy of a new term infant formula supplemented with a prebiotic vs a standard infant formula fed for 150 days to healthy, term infants.

Eligibility criteria: Inclusion Criteria:

* Written Informed Consent
* Infants whose parent(s)/LAR have reached the legal age of majority in the Philippines
* Infants whose parent(s)/LAR are willing and able to comply with study requirements
* Infants whose parent(s)/LAR are able to be contacted by telephone throughout the study
* Healthy term, singleton infant at birth
* Between 21 to 26 days post-natal age at enrollment visit
* Weight-for-length and head circumference-for-age z-scores \>/= - 3 and \</= +3 according to WHO Child Growth Standards
* Infants of parent(s)/LAR who have previously made the decision to formula feed their infant at the time of enrollment

Exclusion Criteria:

* Infants with conditions requiring infant feedings other than those specified in the protocol
* Infants receiving complementary foods or liquids
* Infants who have a medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results
* Infants who are presently receiving or have received medications that could interfere with the interpretation of study results
* Infants or infants whose parents/LAR cannot be expected to comply with the protocol or with study procedures

Primary outcomes:
measure: Growth
timeFrame: 150 days
measure: Stool Consistency Score
timeFrame: 150 days
Secondary outcomes:
measure: Weight
timeFrame: 150 days
measure: Average Daily Stool Frequency
timeFrame: 150 days
measure: Fecal Microbiota
timeFrame: 150 days
measure: Fecal Markers
timeFrame: 150 days
measure: Adverse Events
timeFrame: 150 days
Other outcomes:
Locations:
city: Muntinlupa
country: Philippines
facility: Asian Hospital and Medical Center
Study officials:
affiliation: Asian Hospital and Medical Center
name: Elvira M Estorninos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03660163: Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography.
Official title: Assessment of the Outcome of Endodontic Treatment Using Cone Beam Computed Tomography-A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Periapical Periodontitis
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2018-09-06
Enrollment: 65
Sex: ALL
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: Patients referred to the endodontic postgraduate unit at Guy's Hospital.

Brief summary: The aim of the study is to assess the correlation between pre-obturation bacterial detection using fluorescence amplification and outcome of endodontic treatments. Thus, enabling a suitable detection threshold to predict the likelihood of treatment failure. This has the potential to be used a bench side tool in general dental practice to act as a surrogate endpoint for clinicians performing root canal treatment.

Detailed description: Pre-obturation root canal samples were taken using paper points from patients undergoing primary root treatments. The samples were analyzed using a fluorescent spectrometer and a molecular fluorescent vital dye (Calcein AM).

Pre-operative and 1-year post-operative periapical radiographs and Cone Beam Computed Tomography (CBCT) scans were assessed by two calibrated expert examiners to evaluate the outcome of the root canal treatments.

The use of a chairside bacterial stain can allow the clinician to predict the outcome of treatment with confidence. Sampling the root canal space with endodontic paper points followed by ex-situ fluorescent staining and analysis provides a patient-friendly, simple to use and rapid way of predicting root canal treatment outcome.

Eligibility criteria: Inclusion Criteria:

* Patients with at least one tooth diagnosed with the endodontic disease.
* teeth that were tender to percussion and palpation.
* teeth that had a sinus tract and/ swelling.
* Both primary treatment teeth and teeth which had already been root treated were considered.

Exclusion Criteria:

* Patients were excluded if they were pregnant.
* Immunosuppressed patients.
* Non-restorable teeth.
* Teeth with a periodontal probing depth greater than 3mm.
* Teeth with apical radiolucencies with the longest dimension above 1.2cm.

Primary outcomes:
measure: Periapical periodontium health
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King's College London
name: Shanon Patel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Knight A, Blewitt I, Al-Nuaimi N, Watson T, Herzog D, Festy F, Patel S, Foschi F, Koller G, Mannocci F. Rapid Chairside Microbial Detection Predicts Endodontic Treatment Outcome. J Clin Med. 2020 Jul 3;9(7):2086. doi: 10.3390/jcm9072086.
Clinical trial NCT02447263: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Cancer
Official title: HepaSphere Interventional Therapy Using Digital Subtraction Angiography（DSA） for Liver Cancer: Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Liver Cancer
Keywords: Liver Cancer
HepaSphere
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-05-18
Enrollment: 87
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 evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for liver cancer.

Detailed description: By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） for liver cancer.

Eligibility criteria: Inclusion Criteria:

1. Age:18-80
2. Karnofsky performance status \>60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive interventional therapy
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except pancreatic cancer
2. History of coagulation disorders or anemia

Primary outcomes:
measure: Number of participants with Adverse events
timeFrame: 1 year
Secondary outcomes:
measure: Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
timeFrame: 1 year
measure: Progress free disease (PFS)
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 3 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Central laboratory in Fuda cancer hospital
state: Guangdong
Study officials:
affiliation: Fuda Cancer Hospital
name: Lizhi Liu, PhD
role: STUDY_CHAIR
References:
citation: Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24.