louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06309511: Subendocardial Viability Ratio in Hypertension
Official title: Subendocardial Viability Ratio in Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Keywords: Myocardial ischemia
Buckberg index
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2024-03-13
Enrollment: 3000
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: Hypertensive patients

Brief summary: The aim of the research is to evaluate the Subendocardial Viability Ratio (SEVR) in hypertensive patients, using non-invasive arterial tonometry, and to establish the influencing factors and the possibility of predicting cardiovascular morbidity and mortality in arterial hypertension.

The SEVR will be evaluated on all patients belonging to the Arterial Hypertension Centers undergoing non-invasive arterial tonometry.

The SEVR is calculated on the morphology of the central pressure wave as the ratio between the DPTI (diastolic pressure-time index), i.e. the area between the carotid pressure curve and the ventricular pressure curve during the diastolic phase, and the SPTI ( systolic pressure-time index), i.e. the area under the carotid pressure curve during the systolic phase.

The SEVR will be correlated with the anthropometric and pathology variables which will be collected in an appropriate database.


Eligibility criteria: Inclusion Criteria:

* Hypertension

Exclusion Criteria:

* Atrial fibrillation

Primary outcomes:
measure: Buckberg index
timeFrame: At recruitment, at 1 year, 2 years, 3 years and 4 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Mascalucia
country: Italy
facility: Centro di Prevenzione e Cura dell'Ipertensione Arteriosa "Alessandro Filippi"
state: Catania
city: Bari
country: Italy
facility: Unità Operativa Semplice Dipartimentale Ipertensione Arteriosa "Anna Maria Pirrelli", Università degli Studi di Bari "Aldo Moro". Policlinico Consorziale di Bari
city: Milano
country: Italy
facility: Istituto Auxologico Italiano IRCCS
city: Reggio Emilia
country: Italy
facility: Medicina II Cardiovascolare, AUSL-IRCCS di Reggio Emilia
city: Trieste
country: Italy
facility: Dipartimento di Scienze Mediche, Chirurgiche e della Salute, Università degli studi di Trieste
Study officials:
References:
Clinical trial NCT04606511: Lymphedema Screening
Official title: Screening for Lymphedema
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphedema
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, there is no established screening program for lymphedema. This cross-sectional study will investigate diagnostic modalities in screening for lymphedema in patients with and without known lymphedema after breast cancer.


Eligibility criteria: Inclusion Criteria:

* Previous breast cancer treated with axillary lymph node dissection
* No recurrence
* Understand the study
* Can talk, read and understand Danish

Exclusion Criteria:

* Pregnant or breast feeding
* Lymph node dissection from other basins
* Psychiatric disorder
* Not possible to perform indocyanine green lymphangiography

Primary outcomes:
measure: sensitivity, specificy, NPV and PPV
timeFrame: through study completion, approximately 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of Plastic and Reconstructive Surgery
Study officials:
References:
Clinical trial NCT02401711: How Should Surgical Residents Be Educated About Patient Safety
Official title: How Should Surgical Residents Be Educated About Patient Safety in the Operating Room: a Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Education
Patient Safety
Educational Safety Curriculum
Surgical Resident
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the effectiveness of two methods, safety curriculum in addition to online training alone, for teaching patient safety to surgery residents. Despite multiple studies evaluating educational safety curricula, the best methods for teaching residents about patient safety is unknown. It is hypothesized that empowering surgery residents to actively engage in behaviors to increase patient safety may lead to a higher quality perioperative care and communication.


Eligibility criteria: Inclusion Criteria:

* All surgery residents at the University of Texas Health Science Center at Houston, from post-graduate year (PGY)-1 to PGY-5.

Exclusion Criteria:

* Non-surgery residents at the University of Texas Health Science Center at Houston.

Primary outcomes:
measure: Changes in safety culture as measured by the Safety Attitudes Questionnaire (SAQ)
timeFrame: Baseline, One year
Secondary outcomes:
measure: Learner satisfaction, knowledge, and behaviors as measured by the Oxford Non-Technical Skills (NOTECHS) system
timeFrame: One year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00263211: A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
Official title: The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Breast Cancer
Metastatic
Platelet
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Barnes-Jewish Hospital
First posted: 2005-12-07
Enrollment: 48
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: The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Women with metastatic breast cancer who are completing planned course of chemotherapy with planned treatment break
* On stable hormone therapy for at least 2 months are also eligible for the study
* Estimated survival of at least 3 months
* No platelet inhibitor therapy within 1 month of study entry
* Platelets ≥ 100,000
* Coagulation screening tests within normal range (INR between 0.81 and 1.20)
* Normal kidney and liver function as defined by:

  * Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase(ALT) ≤ 2 x Institutional Normal
  * Creatinine ≤ 2 x Institutional Normal
* Able to provide signed, informed consent.

Exclusion Criteria:

* Patients going on to surgery
* Patients with a serious bleeding disorder that make them inappropriate candidates for NSAID therapy
* Patients with history of significant bleeding related to peptic ulcer disease
* Patients on standing doses of NSAIDS or platelet function inhibitors
* Patients on standing doses of anti-coagulants

Primary outcomes:
measure: Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
timeFrame: Week 4
measure: Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug
timeFrame: Maximum of 6 months
Secondary outcomes:
measure: Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
timeFrame: Baseline, 2 weeks and 1 month
measure: Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
timeFrame: Baseline, 2 weeks and 1 month
measure: Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
timeFrame: Baseline, 2 weeks and 1 month
measure: Progression Free Survival
timeFrame: Maximum of 6 months
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: Katherine N Weilbaecher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02218411: Video-supported Group-based Otago Exercise Programme on Physical Performance in Older Adults.
Official title: Effectiveness of a Video-supported Group-based Otago Exercise Programme on Physical Performance in Community-dwelling Older Adults: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Aging
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2014-08-18
Enrollment: 55
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effects of a video-supported group-based Otago exercise programme intervention on balance, mobility, physical performance and aerobic endurance in community-dwelling older adults 65+ years old.


Eligibility criteria: Inclusion Criteria:

* Aged 65 years and older.
* Living in the community (Valencia, Spain).
* Able to ambulate independently without a walking aid.
* Have no severe medical contraindication for physical activity.
* Able to communicate.
* Have self-reported visual and auditory capacities to follow commands.
* Provide signed informed consent.

Exclusion Criteria:

* Unable to ambulate independently.
* Mini-mental state examination score of \<24.
* Barthel Index score of \<80.
* Severe visual and auditory disabilities.
* Unstable cardiovascular disease.
* Neurological disorder that could compromise them from exercising.
* Upper or lower extremity fracture in the past year.

Primary outcomes:
measure: Change in the Timed Up and Go test
timeFrame: Pre intervention and after 4-month intervention
Secondary outcomes:
measure: Change in the Berg Balance Scale
timeFrame: Pre intervention and after 4-month intervention
measure: Change in the 6.min Walk Test
timeFrame: Pre intervention and after 4-month intervention
measure: Change in the One-Leg Stand
timeFrame: Pre intervention and after 4-month intervention
measure: Change in the Short Physical Performance Battery
timeFrame: Pre intervention and after 4-month intervention
Other outcomes:
Locations:
Study officials:
affiliation: CEU UCH
name: Vicent Benavent-Caballer, PT, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benavent-Caballer V, Rosado-Calatayud P, Segura-Orti E, Amer-Cuenca JJ, Lison JF. The effectiveness of a video-supported group-based Otago exercise programme on physical performance in community-dwelling older adults: a preliminary study. Physiotherapy. 2016 Sep;102(3):280-6. doi: 10.1016/j.physio.2015.08.002. Epub 2015 Sep 1.
Clinical trial NCT06851611: The Safety and Antibody Response of the Nasal COV2 Vaccine Against the SARS-CoV-2 Virus
Official title: An Open Short-term Clinical Pilot Trial on Safety and Immunogenicity of Nasal COVID-19 Vaccine at Different Dose Levels and Administration Methods
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: COVID19, Sars-Cov-2
Keywords: nasal vaccine
adeno-vectored vaccine
mucosal vaccine
Sars-CoV-2
COVID19
Lead sponsor: Rokote Laboratories Finland Oy
Sponsor class: INDUSTRY
First posted: 2025-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: COV2 is a nasal, investigational vaccine against COVID-19, based on a serotype 5 adenoviral vector producing the SARS-CoV-2 spike protein. In this trial, the primary comparison in terms of safety and immunogenicity will be between two different dose levels of COV2 booster vaccine (low, high), and two different administration methods (nasal drops, nasal spray). In addition, COV2 vaccine will also be evaluated in vaccine naive subjects.


Eligibility criteria: Inclusion Criteria

1. Has voluntarily signed the written informed consent
2. 18-75 years old
3. Good general health
4. a) Prior vaccination with at least two doses of any COVID-19 vaccine, OR b) No prior COVID-19 vaccination

Exclusion Criteria

1. Pregnant, planning to become pregnant or breastfeeding women
2. COVID-19 infection within the last nine (9) months
3. Any other vaccination within the last two (2) months

Primary outcomes:
measure: Primary Immunogenicity
timeFrame: 28 days from baseline
measure: Primary Safety
timeFrame: 28 days from baseline
Secondary outcomes:
measure: Secondary Immunogenicity
timeFrame: 28 days from baseline
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
state: Northern Savonia
Study officials:
affiliation: Rokote Laboratories Finland Oy
name: Seppo Ylä-Herttuala, MD, PhD
role: STUDY_DIRECTOR
affiliation: Rokote Laboratories Finland Oy
name: Erkko Ylösmäki, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03590028: An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury
Official title: An Early Real-Time Electronic Health Record Risk Algorithm for the Prevention and Treatment of Acute Kidney Injury: A Randomized Trial of an Early Standardized, Personalized Nephrology Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Kidney Injury
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2018-07-18
Enrollment: 180
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: This is a single center randomized trial that seeks to determine if the use of an automated real-time electronic medical record Acute Kidney Injury (AKI) risk score can improve patient outcomes through the use of an early standardized nephrology focused intervention.


Eligibility criteria: Inclusion Criteria:

1. Age \>18 years old
2. Initial ESTOP AKI score ≥0.01 within the last 8 hours.

Exclusion Criteria:

1. Voluntary refusal or missing written consent of the patient / legal representative.
2. Patients with a known history of end-stage renal disease on dialysis (including renal transplantation).
3. Patients without a measured serum creatinine value during their inpatient stay.
4. Patients with a creatinine \>4.0 mg/dl at the time of admission or available in the electronic health record (EHR) from the last 6 months.
5. Patients with prior episode of Kidney Disease Improving Global Outcomes (KDIGO) defined AKI during this same hospitalization- regardless of ESTOP AKI score.
6. Patients with prior renal consultation during their admission.

Primary outcomes:
measure: Peak change in milligrams per deciliter (mg/dL) in serum creatinine (SCr) level over a 7-day interval
timeFrame: 7-day interval
Secondary outcomes:
Other outcomes:
measure: Differences by treatment group in the proportion by percent and time in days to specified medical events.
timeFrame: 3 months
measure: Comparison of treatment groups in the proportion by percent and time in days of length of stay (LOS) in the hospital.
timeFrame: 3 months
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago Medicine
name: Jay Koyner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01361828: Optic Nerve and Retinal Functions With Bevacizumab
Official title: Electrophysiological Assessment of Optic Nerve and Retinal Functions Following Intravitreal Injection of Bevacizumab (Avastin).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroidal Neovascular Membrane
Keywords: Bevacizumab
VEP
ERG
Optic nerve and retinal functions following intravitreal bevacizumab
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2011-05-27
Enrollment: 45
Sex: ALL
Minimum age (years): 24
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.Mean age was 50 years ranging from 24-62 years with 25 females, with 28 AMD and 17 myopic patients.

Brief summary: The purpose of this study is to investigate the possible affection of optic nerve and retinal functions following intravitreal bevacizumab injection in human eyes.

Detailed description: To evaluate the retinal and optic nerve functions of bevacizumab when injected intravitreal in human eyes using electrophysiological tests; Electroretinogram (ERG) and Visual Evoked Potentials (VEP). Forty five eyes of 45 patients with choroidal neovascular membrane (CNV) who were prepared for intravitreal injections of 1.25mg bevacizumab underwent baseline ERG and VEP in both eyes before, and at 1 and 4 weeks after the intravitreal injections.

Eligibility criteria: Inclusion Criteria:

* CNV

Exclusion Criteria:

* Previous Intravitreal Injections

Primary outcomes:
measure: Visual Evoked Potential and Electroretinogram
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
state: --- Select One ---
Study officials:
affiliation: Cairo University
name: Tamer A macky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00481728: Evaluation of the Link Between Bladder Sensation and Changes in Skin Electrical Conductance and Heart Rate.
Official title: Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive Bladder and Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Measuring sympathetic skin response or heart rate variability can provide an objective biomarker of bladder sensation and its modulation by drug with potential to treat overactive bladder.

Detailed description: Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.

Eligibility criteria: Inclusion Criteria:

* Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating

Exclusion Criteria:

* History of lower urinary tract pathology
* Excessive alcohol and tobacco consumption
* Treatment with investigational drug in the last 30 days
* Abnormal ECG trace
* Conditions that would contraindicate the use of tolterodine or any other anti muscarinic agent

Primary outcomes:
measure: Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients
Secondary outcomes:
measure: To investigate the correlation between the changes in heart rate variability and sympathetic skin response evoked by filling cystometry and intravesical neurostimulation in OAB patients.
timeFrame: duration of study
measure: To determine whether there is a difference in the stimulus response relationship for the evoked changes in HRV and SSR between healthy volunteers and OAB patients.
timeFrame: duration of study
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00004428: Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Keywords: cardiovascular and respiratory diseases
cystic fibrosis
genetic diseases and dysmorphic syndromes
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
Collaborators: name: SciClone Pharmaceuticals
First posted: 1999-10-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the safety of ascending doses of CPX administered to adult patients with mild cystic fibrosis.

II. Evaluate the pharmacokinetics of ascending doses of CPX in this patient population.

Detailed description: PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, dose escalation study.

There are 7 experimental cohorts, each treated with a different oral dose of CPX or placebo. Within each cohort, 4 patients receive a single dose of CPX and 1 patient receives placebo. Each patient is monitored 24 hours postdose. Escalation to the next dose level for each subsequent cohort begins only after the safety data obtained from the previous cohort is reviewed and found not to limit dose escalation.

All patients return for a follow up evaluation 1 week after dosing.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

* Mild cystic fibrosis
* Not pregnant or nursing Negative pregnancy test

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SciClone Pharmaceuticals
name: Eduardo Martins
role: STUDY_CHAIR
References:
citation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.