louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04540133: Dexamethasone Solution and Dexamethasone in Mucolox™
Official title: Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Lichen Planus
Mucous Membrane Pemphigoid
Pemphigus Vulgaris
Chronic Graft-versus-host-disease
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Topical steroid therapy is considered the first line of treatment for Oral Inflammatory Ulcerative Diseases with current treatment regimens requiring multiple application or rinses daily. Using Mucolox™ as a vehicle to deliver topical dexamethasone to the oral mucosa has the potential to effectively prolong contact time between the medication. The primary objective of this study is to determine the clinical efficacy and tolerability of compound dexamethasone at 0.5 mg/5 mL in Mucolox™ for the treatment of Oral Inflammatory Ulcerative Diseases as measured by a reduction in oral symptoms between patients treated with compounded dexamethasone 0.5mg/5ml solution in Mucolox™ (group A) and patients treated with topical commercial dexamethasone 0.5mg/5ml solution only (group B). and mucosa, leading to improved clinical outcomes due to the need for less frequent application.


Eligibility criteria: Inclusion Criteria:

* Age 18 years and older.
* Patients with symptomatic biopsy proven Oral Inflammatory Ulcerative Diseases (worst VAS sensitivity score ≥ 7 over the last week).
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients already on topical or systemic steroids.
* Inability to comply with study instructions.
* Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements.
* VAS sensitivity score \< 7.
* Pregnant women. A urine pregnancy test will be performed for women of child bearing potential.
* Allergy to fluconazole.

Primary outcomes:
measure: Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Sol Silverman Oral Medicine Clinic - UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Alessandro Villa, DDS, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02646033: Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
Official title: Quantitative Rise in Intraocular Pressure in Steep Trendelenburg Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraocular Pressure
Keywords: Intraocular Pressure, Trendelenburg position
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2016-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing robotic surgeries in steep trendelenburg position

Brief summary: This study analyse the rise in Intraocular Pressure while patient is in surgery in head low position.

Detailed description: Patient undergoing robotic surgeries requires steep trendelenburg position (upto 60 degrees) along with pneumoperitoneum. These both can cause a significant rise in intraocular pressure. Significant rise of pressure for prolonged period can cause post operative visual disturbances, which can be of medicolegal importance. Thus studying the quantitative rise and thus trend of intraocular pressure is first step in managing ophthalmic changes during robotic surgeries.

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists (ASA) status 1-3
* without any ophthalmic complains or interventions

Exclusion Criteria:

* lasix given during preoperative or intraoperative period
* cardiac patients who are on medications for stents or post Coronary Artery Bypass Graft (CABG)
* pre-existing glaucoma, eye surgeries, cataract or retinal vascular diseases, corneal diseases which may affect IOP measurement were excluded

Primary outcomes:
measure: Intraocular pressure
timeFrame: 7-8 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Rajiv Gandhi Cancer Institute & Research Centre
state: Delhi
Study officials:
affiliation: Rajiv Gandhi Cancer Institute & Research Centre
name: Nitesh Goel, MBBS,DA, DNB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346033: Evaluation of SCOUT DS in Subjects With Type 2 Diabetes
Official title: An Evaluation of a Non-invasive Diabetes Screening Device in Subjects With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes
Keywords: Type 2 Diabetes
Adults 18 years and older
Taking Control of Your Diabetes Health Fair
Lead sponsor: VeraLight, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Attendees of the Taking Control of Your Diabetes Health Fair, San Diego CA Convention Center

Brief summary: The primary objective of the trial is to collect SCOUT DS and Hemoglobin A1c measurements of subjects who have been diagnosed with Type 2 diabetes.

Detailed description: Previous studies have excluded subjects with Type 2 diabetes. The primary objective of this study is to correct an imbalance in the disease prevalence of the data set used to develop the SCOUT DS diabetes screening algorithm.

Eligibility criteria: Inclusion Criteria:

1. Age greater than or equal to 18 years
2. Self-reported diagnosis of type 2 diabetes

Exclusion Criteria:

* Not diagnosed with type 2 diabetes

  * Diagnosed with type 1 diabetes
  * Known to be pregnant (Self Reported)
  * Receiving dialysis or having known renal compromise
  * Scars, tattoos, rashes or other disruption/discoloration on the left volar forearm.
  * Known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity)

Primary outcomes:
measure: Validation of SCOUT DS algorithm for detecting known type 2 diabetes
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Convention Center
state: California
Study officials:
affiliation: Accelovance San Diego
name: Martin L Kabongo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00818233: Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
Official title: Intra-observer and Inter-observer Variability With Dynamic Contour Tonometry.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intraocular Pressure
Keywords: dynamic contour tonometry
variability
pulse amplitude
Ocular pulse amplitude
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-01-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy, competent adults with normal, healthy eyes.

Brief summary: The aim of the protocol is to document intra-observer and inter-observer variability with dynamic contour tonometry, and will also test the theory that pulse amplitude, as measured by dynamic contour tonometry, is correlated with the difference in systolic and diastolic blood pressures.


Eligibility criteria: Inclusion Criteria:

* Normal, healthy eyes
* Minimal to moderate refractive error
* Willingness to participate in the study

Exclusion Criteria:

* Diagnosis of any type of glaucoma
* Any prior ocular surgery
* Any prior ocular trauma
* Any known anterior segment pathology

Primary outcomes:
measure: The variability of intraocular pressure measurements using dynamic contour tonometry
timeFrame: Same day
Secondary outcomes:
measure: Observe how pulse amplitude, as measured by dynamic contour tonometry, correlates with the difference in systolic and diastolic blood pressures
timeFrame: Same day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Eye Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Hylton R Mayer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06800833: Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health
Official title: Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gut Microbiome
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.


Eligibility criteria: Inclusion Criteria:

* Generally healthy subjects
* BMI 20-40 kg/m2

Exclusion Criteria:

* Smoker
* Pregnant woman
* Required antibiotics use
* Required dietary supplement use
* Required medication of metabolic disorders, mental health and sexual health
* Allergy to mango or wheat

Primary outcomes:
measure: Change of sexual health questionnaire scores
timeFrame: Baseline and week 4
measure: Change of depression questionnaire scores
timeFrame: Baseline and week 4
measure: Change of skin hydration scores
timeFrame: Baseline, 1 min post application and week 4consumption
measure: Change of microbiome diversity
timeFrame: Baseline and week 4
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
References:
Clinical trial NCT03539133: Systemic Organ Communication in STEMI
Official title: Systemic Organ Communication in STEMI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: STEMI
infarction
coronary artery disease
comorbidities
diabetes
anemia
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 1000
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 suffering from STEMI

Brief summary: Despite progress in pre-hospital care, ambulance logistics, pharmacotherapy and PPCI techniques, ST-segment elevation myocardial infarction (STEMI) continues to confer a substantial burden of morbidity and mortality.

Within the STEMI population, there is a spectrum of higher and lower risk patients. The aim of this cohort study is to collect prospectively and systematically clinical research data from STEMI patients. This cohort study is an open-end observational study to identify master switches in myocardial ischemia.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from STEMI

Exclusion Criteria:

* \< 18 years

Primary outcomes:
measure: MACCE (cardiovascular death, non-fatal stroke or myocardial infarction)
timeFrame: 12 months
measure: Rehospitalization due to heart failure
timeFrame: 12 months
Secondary outcomes:
measure: Patency rate
timeFrame: 6 months
measure: left ventricular enddiastolic volume index (LVEDVi)
timeFrame: 6 months
measure: Ejection fraction (%)
timeFrame: 6 months
measure: stroke volume
timeFrame: 6 months
measure: Restenosis rate
timeFrame: 6 months
Other outcomes:
Locations:
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
Study officials:
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Christian Jung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Cardiology, Pulmonary Disease and Vascular Medicine
name: Malte Kelm, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03147833: Protein Before Night Sleep to Improve Recovery and Performance in Runners
Official title: Ingestion of Protein Before Each Night Sleep to Improve Recovery and Performance in Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-05-10
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 32 runners will be randomized into two groups. The duration of the intervention is one week including a strenuous endurance training program. Group 1 receive a protein beverage before each night sleep and Group 2 receive an isocaloric carbohydrate beverage. Performance test before and after the intervention and blood sampling before and during the intervention to check for markers for muscle damage.


Eligibility criteria: Inclusion Criteria: VO2max \>55 ml O2/kg/min -

Exclusion Criteria:women, smokers

-

Primary outcomes:
measure: Performance
timeFrame: 8 days
Secondary outcomes:
measure: Muscle damage
timeFrame: 8 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
affiliation: University of Aarhus
name: Mette Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00430833: CHANCE - Candesartan in Hypertrophic Cardiomyopathy
Official title: Candesartan Use in Hypertrophic and Non-Obstructive Cardiomyopathy Estate (The CHANCE): a Double-Blind, Placebo-Controlled, Randomized, Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-02-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary hypothesis of the study is that treatment with AT1-R antagonist in patients with nonobstructive form of HCM will be first save, second will cause regression of myocardial hypertrophy.

Detailed description: Patients will be randomly assigned in 1:1 ratio either to candesartan (target dose 32 mg once daily) or matching placebo. The initial dose of the study drug will be 8 mg once daily. Study drug dose will be then doubled as tolerated every 2 weeks while aiming for a target dose of 32 mg once daily. Monitoring of blood pressure, serum creatinine, serum potassium and pressure gradient in LV outflow tract will be performed during dose increase. Patients will be observed clinically at 3, 6, and 12 months after the maintenance dose was reached. Exercise tolerance will be assessed by bicycle ergometry, presence of malignant arrhythmias by Holter monitoring, extent of LV hypertrophy by 2-dimensional echocardiography, and LV outflow tract pressure gradient by Doppler echocardiography at baseline and 12-month follow-up.

Eligibility criteria: Inclusion Criteria:

* HCM defined on the basis of echocardiographic criteria showing a nondilated, hypertrophied left ventricle (any wall thickness \> 15 mm) in the absence of known causes of LV hypertrophy hypertension or valvular disease

Exclusion Criteria:

* Hypertrophic obstructive cardiomyopathy defined as presence of resting gradient in left ventricular outflow tract ³30 mmHg or in righ ventricular outflow tract ³15 mmHg at Doppler echocardiography;
* Atrial fibrillation;
* Treatment with ACE inhibitors or AT1-R antagonists any time in the past;
* Contraindications to AT1-R antagonists;
* Coronary artery disease, renal failure, hepatic disorders or serious intercurrent illness limiting survival; and
* Poor echocardiographic image quality.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Cardiocenter, Third Faculty of Medicine, Charles University
Study officials:
affiliation: Charles University, Prague, Czech Republic
name: Martin Penicka, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penicka M, Gregor P, Kerekes R, Marek D, Curila K, Krupicka J; Candesartan use in Hypertrophic And Non-obstructive Cardiomyopathy Estate (CHANCE) Study Investigators. The effects of candesartan on left ventricular hypertrophy and function in nonobstructive hypertrophic cardiomyopathy: a pilot, randomized study. J Mol Diagn. 2009 Jan;11(1):35-41. doi: 10.2353/jmoldx.2009.080082. Epub 2008 Dec 12.
Clinical trial NCT00195533: Study Comparing Piperacillin-tazobactam Versus Piperacillin-tazobactam Plus Glycopeptide in Neutropenic Patients
Official title: Monotherapy With Piperacillin-tazobactam Versus Combination Therapy With Piperacillin-tazobactam Plus Glycopeptide as an Initial Empiric Therapy for Fever in Neutropenic Patients. An Observational Prospective Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematological Malignancy
Leukemia
Myelodysplasia
Lymphoma
Myeloma
Stem Cell Transplantation
Keywords: Leukemia
Lymphoma
Myeloma
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
Collaborators: name: PETHEMA (Program for the Study and Treatment of Haematological Malignances)
First posted: 2005-09-19
Enrollment: 801
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: Hematology units

Brief summary: The aim of this study is to compare the efficacy and tolerance of piperacillin-tazobactam versus piperacillin-tazobactam plus glycopeptide as initial empiric antibiotic treatment for fever in neutropenic patients. Study of consecutive cohorts(2). First the patients will be included in the monotherapy branch until completing the predicted number of cases. When this happens, the Coordinating Center will communicate it to the participant centers and from then the patients will be included in the combined therapy.


Eligibility criteria: Inclusion Criteria:

* Patients with hematological malignancy or those who had undergone stem cell transplantation for neoplastic disease.
* Fever (\>38ºC)
* Neutropenia (absolute neutrophil count \< 500 or \< 1000 anticipated to fall below 500 cells within 24-48 hours).

Exclusion Criteria:

* Known allergy to any of the antibiotics used in this trial
* A high probability of death within 48 hours

Primary outcomes:
measure: - Clinical efficacy evaluation:72 and 96 hours after the initiation of empirical therapy (early evaluation) and at the completion of the therapeutic trial (overall valuation)
timeFrame: 3 months
measure: - Safety evaluation:during the empirical therapy
Secondary outcomes:
measure: Microbiological evaluation:at the completion of the therapeutic trial (overall evaluation)
timeFrame: 3 Months
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
city: Alcira
country: Spain
city: Barcelona
country: Spain
city: Castellon
country: Spain
city: Coruña
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Tarragona
country: Spain
city: Tenerife
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03485833: End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness
Official title: End-expiratory and End-inspiratory Occlusion Tests to Predict Fluid Responsiveness in Mechanically Ventilated Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Surgery
Keywords: end-expiratory occlusion test
end-inspiratory occlusion test
transesophageal echocardiography
passive legs raising
fluid challenge
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to verify the efficacy of using end-expiratory and end-inspiratory occlusion tests as an index of fluid responsiveness in mechanically ventilated patients with cardiac surgery.

Detailed description: Patients with hypotension after anesthetic induction for cardiac surgery, who requires fluid resuscitation based on clinical judgement by the anesthesiologists are enrolled in this study. Patients are monitored by transesophageal echocardiography and FloTrac/Vigileo. Hemodynamic variables (heart rate, systolic blood pressure, diastolic blood pressure, mean artery pressure, central venous pressure, stroke volume variation, cardiac index, velocity time integral of the aorta etc) are measured at baseline, after end-expiratory occlusion (EEO) test, after end-inspiratory occlusion (EIO) test, after passive legs raising test, and after fluid challenge respectively. Responders are defined by an increase in velocity time integral over 15% after infusion of 5ml/kg of crystalloid solution.

Eligibility criteria: Inclusion Criteria:

* cardiac surgical patients
* hypotension after induction of anesthesia
* required volume expansion by clinical judgement of the anesthesiologist

Exclusion Criteria:

* younger than 18 years
* severe valve regurgitation or systolic dysfunction of the right ventricle
* contraindication of the transesophageal echocardiography examination
* cardiac arrhythmia
* left ventricular ejection fraction less than 30% before surgery

Primary outcomes:
measure: responders
timeFrame: within 1 minute after volume expansion
Secondary outcomes:
measure: nonresponders
timeFrame: within 1 minute after volume expansion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan hospital, Fudan university
state: Shanghai
Study officials:
affiliation: Fudan University
name: Guo-wei Tu, PhD
role: PRINCIPAL_INVESTIGATOR
References: