louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02408614: Acute Effect of Exercise on Vascular Function
Official title: Acute Effect of Exercise on Vascular Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aging
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-04-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: General population including men and women 18 to 79 years of age

Brief summary: The study objectives are the following: 1) To examine the acute vascular responses to continuous low- and moderate-intensity exercise and interval training; and 2) To examine the influence of age and gender on these responses.

Detailed description: The type, intensity and duration of exercise, fitness state, and timing of measurements have been reported to influence the acute vascular responses to exercise. However, little is known regarding the influence of interval training, aging and gender on these responses. The objectives of this study are: 1) to examine the acute vascular responses to continuous low- and moderate-intensity exercise and interval training; and 2) to examine the influence of age and gender on these responses. Subjects will perform the following 3 types of treadmill exercise in a random order: 1) slow-pace walking; 2) moderate-pace walking; and 3) interval training. Flow mediated dilation using high resolution ultrasonography and arterial stiffness using applanation tonometry will be measured before, immediately after and 1-hour after each acute bout of exercise.

Eligibility criteria: Inclusion Criteria:

* Men and women 18 to 79 years of age
* Women will be premenopausal or postmenopausal (either natural or surgical) defined as a cessation of menses for at least 2 years.
* Premenopausal women will be eumenorrheic.
* Able to give consent.

Exclusion Criteria:

* History of hepatic disease or infection with hepatitis B, C or HIV
* History of other relevant on-going or recurrent illness
* Recent (within 3 months) or recurrent hospitalizations
* Current intake of medications that may affect study results
* Use of tobacco products
* Premenopausal women taking oral contraceptives and postmenopausal women taking hormone replacement therapy.
* Pregnancy (positive urine pregnancy test) or lactation
* Perimenopausal women

Primary outcomes:
measure: Change in vascular endothelial function
timeFrame: Baseline, 15 minutes after exercise and 1 hour after exercise
Secondary outcomes:
measure: Change in arterial stiffness
timeFrame: Baseline, 15 minutes after exercise and 1 hour after exercise
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Integrative Cardiovascular Physiology Laboratory
state: Florida
Study officials:
affiliation: University of Florida
name: Demetra Christou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04566055: Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance
Official title: Assessing AlloSure Dd-cfDNA Monitoring Insights of Renal Allografts With Longitudinal Surveillance
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplant Rejection
Lead sponsor: CareDx
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant patients

Brief summary: Prospective Observational Multicenter Cohort. External validation of donor derived cell free DNA in Renal Transplantation. Assessing performance of dd-cfDNA as a surveillance tool and its association with clinical outcomes. Outcomes include formation of de-novo DSA, eGFR decline, performance of AlloSure dd-cfDNA in Allograft rejection.


Eligibility criteria: Inclusion Criteria:

* Renal transplant patients

Primary outcomes:
measure: Validation of AlloSure in Allograft rejection
timeFrame: October 2020
Secondary outcomes:
measure: Performance of AS with De-Novo DSAs, Performance in subclinical and protocol biopsies vs clinically indicated for cause biopsies, Survival analysis considering AS surveillance
timeFrame: October 2020
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Tampa
country: United States
facility: Tampa General Hosptial
state: Florida
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Houston
country: United States
facility: Memorial Hermann Hosptial
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References:
Clinical trial NCT01889355: User Study for Enhanced Meter Feature
Official title: User Study for the Evaluation of an Enhanced Meter Feature Using an AgaMatrix BGMS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes
glucose
glucometer
Lead sponsor: AgaMatrix, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-28
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This enhanced meter feature raises awareness among patients by providing additional information regarding their glycemic control in between Healthcare Professional visits. This information may facilitate increased dialogue between patient and Healthcare Professional and can remind patients of the importance of glycemic control.

This study will evaluate a user's ability to use the enhanced meter feature.


Eligibility criteria: Inclusion criteria:

IC 1. Age of subject is 18 years or older

IC 2. Type I or type II diabetes inclusive of the following populations:

1. Mixed insulin therapies
2. Basal insulin therapies
3. Bolus insulin therapies
4. CSII therapies
5. MDI therapies
6. Non-insulin diabetic treatments (oral and injectable)
7. Life style (exercise and diet) diabetes management IC 3. Able to speak and read English proficiently

Exclusion criteria EC 1. Pregnant EC 2. Hct \<20 or \>60 EC 3. Work for BGM competitor company (including, but not limited to Lifescan, Roche, Abbott) EC 4. Homeless EC 5. Incarcerated EC 6. Institutionalized EC 7. Employees or students of the Research Site, including the Principal Investigator, directly involved in the conduct of the protocol.

EC 8. Has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.

EC 9. Previous experience using the MyStar Extra BGMS

Primary outcomes:
measure: Enhanced Meter Feature Usability
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
Study officials:
References:
Clinical trial NCT00641355: Acute Phase Proteins as Early Markers in Sepsis
Official title: Acute Phase Proteins as Early Markers in Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2008-03-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with severe trauma

Brief summary: Monitoring of different serumproteins after severe trauma and during trauma-induced sepsis.

* Trial with surgical intervention


Eligibility criteria: Inclusion criteria:

* Patients with severe trauma (ISS score \> 16), both genders, patients on ICU

Exclusion criteria:

* Moribund patients (pH \<7,1, lactate \>15mmol, Basedeficit \> 15mEq/L, severe heart or liver injuries, GCS never over 5 after trauma)
* Severe head injuries (AIS head \>4)
* Patient with severe infectious diseases, or diseases which severely affect the immune system (diabetes, Alkohol or nicotine abuse)
* Non-german speaking patients

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT02461355: Transcranial Direct Current Stimulation for Post-Stroke Aphasia
Official title: Enhancing Aphasia Therapy With Anodal Transcranial Direct Current Stimulation in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Pitkin Foundation
First posted: 2015-06-03
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, crossover design trial that will compare how anodal transcranial direct current stimulation (tDCS) versus sham tDCS administered during multiple sessions of scripting therapy affects the acquisition and retention of trained scripts.


Eligibility criteria: Inclusion Criteria:

1. Age over 21 years
2. Ischemic left hemispheric stroke verified by imaging (CT or MRI) greater than 6 months ago
3. Residual non-fluent or anomic aphasia, with Western Aphasia Battery-Revised Aphasia Quotient score \<60
4. Fluent English speaker prior to stroke
5. Right-handed prior to stroke
6. Ability to give informed consent and understand the tasks involved.

Exclusion Criteria:

1. History of recurrent stroke, either ischemic or hemorrhagic, in the left middle cerebral artery territory
2. Imaging unavailable
3. Large middle cerebral artery infarct involving entire inferior division (temporo-parietal) territory
4. History of dementia prior to the stroke
5. History of seizure, prior electroconvulsive therapy, deep brain stimulators, or brain surgery
6. Social and/or personal circumstances that interfere with ability to return for therapy and assessment sessions.

Primary outcomes:
measure: Change in Percent Correct of Trained Scripts
timeFrame: From Baseline to up to 2 days post-training
measure: Change in Words Per Minute of Trained Scripts
timeFrame: From Baseline to up to 2 days post-training
Secondary outcomes:
measure: Change in Percent Correct of Trained Scripts
timeFrame: Baseline to 2 weeks and 4 weeks post-training
measure: Change in Words Per Minute of Trained Scripts
timeFrame: Baseline to 2 weeks and 4 weeks post-training
Other outcomes:
measure: Change in Percent Script Words Omitted
timeFrame: Baseline to immediate, 2 weeks, and 4 weeks post-training
Locations:
city: Maywood
country: United States
facility: Adler Aphasia Center
state: New Jersey
Study officials:
affiliation: Columbia University
name: Tomoko Kitago, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00433355: Epstein-Barr Virus as a Possible Cause for Chronic Fatigue Syndrome
Official title: Studies on Epstein-Barr Virus as a Possible Etiological Agent for Chronic Fatigue Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Fatigue Syndrome
Keywords: Chronic Fatigue Syndrome
Epstein-Barr Virus
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2007-02-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 y/o and above with history of CFS matched those without as to age and gender.

Brief summary: The purpose of this study is to understand what causes a continuing fatigue for a long time with a number of symptoms occurring at the same time (Chronic Fatigue Syndrome-CFS). Epstein Barr Virus is among the group of viruses that have been associated with a continuing fatigue for a long time with a number of symptoms occurring at the same time, but the cause is still unknown.

Detailed description: Epstein-Barr virus (EBV) is the etiological agent for heterophile positive infectious mononucleosis (IM). It is also an oncogenic herpes virus associated with African Burkitt's lymphoma (BL),nasopharyngeal carcinoma (NPC) and AIDS-associated B-cell lymphomas. EBV is also among a group of viruses that have been associated with chronic fatigue syndrome (CFS), although the etiology of CFS still remains unknown.Findings may lead to hypothesize that EBV enzymes, such as the dUTPase, have the capacity to induce immune dysregulation of the T-cell and NK cell responses and that this immune dysregulation produces immunopathology that results in the symptoms that we call CFS.

Eligibility criteria: Inclusion Criteria:

* Healthy adults for controls.
* Adults with chronic fatigue syndrome.

Exclusion Criteria:

* Individuals with significant medical illness in reference to immunosuppressant drug.

Note: We recruit participants in the Mississippi area who could come in our site to provide blood draw.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Gailen D Marshall, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03058055: Brain Exercises for Synaptic Plasticity
Official title: Brain Exercises for Synaptic Plasticity: the BEST Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The BEST study will investigate the feasibility of cognitive interventions in a randomized, placebo-controlled, clinical trial. The investigators will recruit 45 cognitively normal subjects and engage them in one of three cohorts over an 8 week period, including active reading vs. origami study arms and a placebo group without structured cognitive intervention.

Detailed description: This is a randomized, placebo controlled study investigating the practical implementation and conduct of two cognitive interventions in non-demented subjects. Subjects will be randomized 1:1:1 into three groups including: 1) a Book club that includes weekly one hour meetings and daily reading assignments, 2) Origami lessons (one hour/week) with daily take home Origami activities to complete, and 3) a placebo group with unstructured lifestyle activities (normal lifestyle activities without restraint).

Eligibility criteria: Inclusion Criteria:

* Non demented community dwelling elders

Exclusion Criteria:

* Unable to perform the reading or origami tasks for any reason

Primary outcomes:
measure: MOCA
timeFrame: 8 weeks
measure: FCSRT
timeFrame: 8 weeks
Secondary outcomes:
measure: Adherence to protocol
timeFrame: 8 weeks
measure: Electroencephalogram
timeFrame: 8 weeks
measure: Evoked Related Potential
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Sander's Brown Center on Aging
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Gregory A Jicha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01977755: Phase 2 Clinical Proof-of-Concept Study of the Cardioprotective Properties of Danegaptide in ST Segment Elevation Myocardial Infarction
Official title: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess Clinical Efficacy and Safety of Danegaptide in Patients With ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Focus of Study is STEMI
Lead sponsor: Zealand Pharma
Sponsor class: INDUSTRY
First posted: 2013-11-07
Enrollment: 591
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 study explores the potential cardioprotective properties of danegaptide when administered to patients with ST-Segment elevation myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* ST-segment elevation myocardial infarction
* Acute onset of chest pain of \< 12 hours duration

Exclusion Criteria:

* Pregnancy
* Known prior Myocardial Infarction in same area as present STEMI, known hypertrophic or dilated cardiomyopathy, or prior hospital admission for heart failure
* Contraindication for cardiac MRI
* Inability to understand information or provide informed consent

Primary outcomes:
measure: Myocardial Salvage Index
timeFrame: 3 months
Secondary outcomes:
measure: Relative Infarct size, Absolute Infarct size, Left Ventricular Ejection Fraction (LVEF), microvascular obstruction and infarct haemorrhage as determined by MRI
timeFrame: 3 months
measure: Degree of ST-resolution and fraction of patients with 70 % ST-resolution measured by ECG 60 minutes post Percutaneous Coronary Intervention procedure
timeFrame: 60 minutes
measure: Major Clinical Adverse Events including cardiac death, new or worsening heart failure and re-admission for heart failure
timeFrame: 3 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Heart Center, Rigshospitalet, University of Copenhagen
Study officials:
affiliation: The Heart Center, Rigshopitalet University of Copenhagen
name: Thomas Engstrom, MD, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engstrom T, Nepper-Christensen L, Helqvist S, Klovgaard L, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Tilsted HH, Steensberg A, Fabricius S, Mouritzen U, Vejlstrup N, Ahtarovski KA, Goransson C, Bertelsen L, Kyhl K, Olivecrona G, Kelbaek H, Lassen JF, Kober L, Lonborg J. Danegaptide for primary percutaneous coronary intervention in acute myocardial infarction patients: a phase 2 randomised clinical trial. Heart. 2018 Oct;104(19):1593-1599. doi: 10.1136/heartjnl-2017-312774. Epub 2018 Mar 30.
Clinical trial NCT06890455: Fecal Calprotectin in Patients Infected with Intestinal Protozoan Infections
Official title: Fecal Calprotectin in Patients Infected with Intestinal Protozoan Infections
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Fecal Calprotectin in Intestinal Protozoa
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 120 fecal samples will be collected as the following:

* 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica.
* 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection.
* 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).

Brief summary: Calprotectin extracted from stool can be detected easily using ELISA. Numerous studies have shown that fecal calprotectin concentrations demonstrate a good correlation with intestinal inflammation This study aims to detect the relationship between fecal calprotectin and Blastocystis hominis and Entamoeba histolytica infections.


Eligibility criteria: Inclusion Criteria:

120 fecal samples will be collected as the following:

* 40 samples from patients complaining of gastrointestinal manifestations and only infected with B.hominis and E.histolytica.
* 40 samples from patients complaining of gastrointestinal manifestations without any protozoal infection.
* 40 healthy control cross-matched volunteers (without gastrointestinal manifestations, or intestinal parasites).

Exclusion Criteria:

* persons received antiparasitic drugs or antibiotic 2 weeks before sample collection Patients with mixed intestinal protozoa Patients with intestinal protozoa rather than Entamoeba histolytica and Blastocystis

Primary outcomes:
measure: Prevalence of Blastocystis and Entamoeba
timeFrame: 2 months
Secondary outcomes:
measure: Number of persons have high fecal calprotectin
timeFrame: 6 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT04001855: Evaluating the Effect of Bathing Additives in Atopic Dermatitis
Official title: Evaluating the Effect of Bathing Additives in Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Atopic Dermatitis
Eczema
Keywords: Atopic Dermatitis
Eczema
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 3
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control split body study
Primary purpose: TREATMENT

Brief summary: This proposed project will be an open-label, split-arm, randomized controlled pilot study. Up to 60 patients diagnosed with atopic dermatitis (eczema) will be enrolled in the study. The purpose of this study is to understand the change in skin barrier function and skin microbial composition in patients with atopic dermatitis following dilute bleach bath/soak and dilute vinegar bath/soak.

Detailed description: Atopic dermatitis (AD), also known as eczema, is an inflammatory skin condition that affects children and adults and causes skin redness, dryness and itching. Dilute bleach baths are standard of care for treatment of AD and work to decrease skin inflammation and modulate the skin microbiome. Dilute vinegar (acetic acid) has been reported to have similar effects on the skin. The purpose of this study is to evaluate the change in skin barrier function and skin microbial composition following baths or gauze soaks with dilute bleach and dilute vinegar.

Eligibility criteria: Inclusion Criteria:

* Males and females, at least 5 years of age
* Subjects, parents/legal guardians must be able to comprehend and read the English language
* Subjects must have a diagnosis of atopic dermatitis (AD) by a board-certified dermatologist

Exclusion Criteria:

* Subjects who do not fit the inclusion criteria
* Subjects unable or unwilling to comply with the study procedures
* Concurrently have other inflammatory skin conditions
* Prior known allergies to any components of the materials used
* A subject who in the opinion of the investigator will be uncooperative or unable to comply with study procedures
* Subject unable to speak or read the English language
* Those that are pregnant, prisoners or cognitively impaired

Primary outcomes:
measure: Skin barrier function - Transepidermal water loss (TEWL)
timeFrame: Up to 21 days
measure: Skin barrier function - Stratum corneum hydration
timeFrame: Up to 21 days
measure: Skin barrier function - pH
timeFrame: Up to 21 days
measure: Skin culture swab
timeFrame: Up to 21 days
measure: Change in Eczema Area and Severity Index (EASI)
timeFrame: Up to 21 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University Medicine Dermatology
state: Arizona
Study officials:
References: