louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04055064: The Effects of Nutrition Supplementation and Education on the Healing of Diabetic Foot Ulcer (DFU)
Official title: Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: DFU, wound healing, nutrition education,supplementation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 29
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall aim of this study was to assess the effects of nutritional supplementation and education on the healing of foot ulcers in diabetic patients. The hypothesis was that improving dietary intake can promote wound healing by improving nutritional status, blood flow, and decreasing inflammatory biomarkers while increasing anti-inflammatory factors.


Eligibility criteria: Inclusion Criteria:

male or non-pregnant, non-lactating female ages 50 ± 20 years, diagnosis of diabetes mellitus, undergoing pharmacological treatment for glycemic control, with at least one foot with one ulcer of grade 1A based on University of Texas classification -

Exclusion Criteria:

Subjects were excluded from the study if they had HbA1c concentrations \> 12%, bioengineered tissue use within four weeks prior to initial screening, a history of radiation treatment to the ulcer site, known immunosuppression, active malignancy, chronic kidney disease, liver failure/cirrhosis, heart failure and/or myocardial infarction in the past three months, use of warfarin, alcohol abuse, or any mental or physiological condition that may interfere with nutrition education and nutritional supplement intake.-

Primary outcomes:
measure: Improvement in wound healing rate(mm^2/week)
timeFrame: 12 weeks
measure: Change in inflammatory biomarkers
timeFrame: 12 weeks
measure: Change in lean body mass and body fat
timeFrame: 12 weeks
measure: Change in dietary intake of nutrients
timeFrame: 12 weeks
Secondary outcomes:
measure: Length of time that a wound achieves complete wound closure
timeFrame: 12 weeks
measure: Change in basal metabolic rate
timeFrame: 12 weeks
measure: Change in Ankle Brachial Index(ABI)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
References:
Clinical trial NCT00248664: Events Preceding Interstitial Cystitis (EPIC)
Official title: A Case Control Study of Interstitial Cystitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystitis, Interstitial
Keywords: Cystitis, Interstitial
Case-Control Studies
Risk Factors
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2005-11-04
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: EPIC is a case/control study that seeks to identify the risk factors for interstitial cystitis by comparing the experiences and medical histories of 400 women who recently developed IC with 400 similar people who do not have the disease.

Detailed description: This project is a systematic, national study of incident IC cases and controls matched by age and gender. By telephone interview and medical record review, we compare exposures of cases and controls seeking significant differences which may be risk factors for IC. This cohort of incident IC cases will initiate a natural history study of the disease.

Specific Aim 1. To test the hypothesis that certain features that precede onset of IC symptoms, e.g., bacterial cystitis, distinguish IC cases from controls matched for age and gender, and may be risk factors for the disease.

Specific Aim 2. To test the hypotheses that patients with IC have higher prevalences of certain non bladder syndromes, e.g., irritable bowel syndrome, than do controls matched for age and gender.

Specific Aim 3. To test the hypothesis that urine APF, HB EGF, and/or EGF are sensitive and specific diagnostic markers for IC in patients with symptoms of ÿ12 months.

Specific Aim 4. To test the hypotheses that, in an incident cohort, patients with IC have remissions and that certain clinical features, e.g., bacterial cystitis at disease onset, are prognostic factors for remissions.

Eligibility criteria: Inclusion Criteria: Female Adults(18 and over) who have had symotoms of IC for 12 months or fewer

-

Exclusion Criteria: Males,children, those who do not have symptoms of IC or those who have had symtoms for greater than 12 months.

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: John W Warren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03843164: Lung Nodule Characterization by Artificial Intelligence Techniques
Official title: Lung Nodule Characterization by Artificial Intelligence Techniques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Incidental Lung Nodule
Keywords: Solitary Pulmonary Nodule
Multidetector Computed Tomography
Artificial Intelligence
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a chest CT acquired between Jan 1 2012 and Oct 1 2018 at the Strasbourg University Hospital;

Brief summary: Management of incidental lung nodule is difficult and mainly based on simple morphometric characteristics such as maximum size and shape. Radiomics could play a role in simplifying this management by orientating towards a benign or a malignant origin, by comparing advanced characteristics to a large database of lung nodules.

The primary purpose is to evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.

The secondary objectives are:

* to evaluate the variation in the performances of the software based on various technical aspects of the CT, such as radiation dose, reconstruction algorithm, type of scanner,...
* to compare the performances of this software to those of expert readers,
* to analyze the potential impact of this software on patient's management.


Eligibility criteria: Inclusion Criteria:

* Adult patient (at least 18 years old);
* With a chest CT acquired between Jan 1 2012 and Oct 1 2018 at the Strasbourg University Hospital;
* CT being available over the PACS and exhibiting at least one lung nodule;
* Patient having given its authorization for the exploitation of his medical data for this research.

Exclusion Criteria:

* Patient having expressed direct opposition to participation in this study;
* Patient under juridical protection;
* Patient under tutelage or guardianship.

Primary outcomes:
measure: Evaluate the performances of a novel tool based on radiomics to characterize incidental lung nodules, discovered on computed tomography.
timeFrame: he period from January 1st, 2012 to October 01, 2018 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Radiologie B - NHC
Study officials:
References:
Clinical trial NCT02587364: Pharmacokinetics and Pharmacodynamics Study of Gemcabene in Healthy Volunteers
Official title: An Oral, Rising, Multiple-Dose Tolerance, Pharmacokinetic and Pharmacodynamic Study of Gemcabene Capsules in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: Pharmacokinetics
Lipid Regulator
Lead sponsor: NeuroBo Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the multiple-dose pharmacokinetic characteristics and pharmacologic activity of gemcabene.


Eligibility criteria: Inclusion Criteria:

* Good health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and laboratory assessments
* Body weight: 60-100 kg (desirable)

Exclusion Criteria:

* Use of any medication not considered acceptable by the clinical investigators during the 14-day period before the start of the study (Day 1) ;
* Donation of a unit of blood or participation in a study of investigational or marketed drugs during the 30-day period before the start of the study (Day 1);
* If female, of childbearing potential or lactating;
* History of significant reaction to any fibrate lipid-lowering agent; and
* Significant urine collection of any drug which could interfere with the study

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 29 days
measure: Pharmacokinetcis
timeFrame: 29 days
Secondary outcomes:
measure: Plasma lipid levels - percent change from baseline at Day 29
timeFrame: 29 days
measure: Adverse Events
timeFrame: 29 days
measure: ECG
timeFrame: 29 days
measure: Clinical Laboratory - hematology, chemistry
timeFrame: 29 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03347864: 68Ga-NOTA-RM26 PET/CT in Breast Tumor Patients
Official title: Diagnostic Performance of 68Gallium-labeled NOTA-RM26 PET/CT in Breast Tumor Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Breast Tumor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is an open-label positron emission tomography/computed tomography(PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-RM26 in breast tumor patients. 1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26A will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed description: The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to assess its clinical diagnostic value in patients with breast tumor.

Eligibility criteria: Inclusion Criteria:

* patients in suspicion of breast cancer by mammography or ultrasonography,and being able to provide basic information and sign the written informed consent form

Exclusion Criteria:

* The exclusion criteria included claustrophobia, pregnancy, breastfeeding, kidney or liver failure, inability to fulfill the study, and undergoing any preceding local or systemic therapies that might interfere with GRPR binding

Primary outcomes:
measure: Standardized uptake value of 68Ga-NOTA-RM26 in breast tumor
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events collection
timeFrame: 1 week
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
name: Zhaohui Zhu, MD,PHD
role: STUDY_CHAIR
References:
Clinical trial NCT02916264: The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion
Official title: The Effect of Scalp Block on Surgical Pleth Index(SPI) During a Mayfield Head-holder Insertion in Neurosurgery : a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: scalp block, surgical peth index
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2016-09-27
Enrollment: 30
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: PREVENTION

Brief summary: It is a randomized control trial to compare the surgical plethysmographic index (SPI) response during a Mayfield head-holder insertion in neurosurgical patients who receive a scalp block versus those who do not receive the scalp block after induction of anesthesia with propofol with fentanyl and intubation with cis-atracurium.

Detailed description: Study design is a randomized controlled trial Participants include adult neurosurgical patients scheduled to have a Mayfield head-holder insertion for supratentorial craniotomy Intervention is a scalp block prior to a Mayfield head holder insertion. Comparison is 'no scalp block' Outcome is surgical plethysmographic index (SPI) responses during/after a Mayfield head holder insertion Sample size includes 30 cases (15 cases per arm)

The eligible neurosurgical patients will be randomly allocated, by a concealed randomization process, to receive or not to receive a scalp block after induction and intubation with propofol/fentanyl and cisatracurium. Surgical plethysmographic index, direct arterial blood pressure, heart rate (EEG), End tidal Carbondioxide, Bispectral/entropy (40-60) will be recorded every one minute before/after induction and intubation, before/after the scalp block, and before/after the Mayfield head-holder insertion. The Mayfield head-holder insertion will be performed by a neurosurgeon who will be blinded to the allocated groups.

Data analysis is performed to compare the change of SPI during and after the Mayfield head-holder insertion from the baseline in both groups by using repeated measure ANOVA at the significant level of 0.05.

Eligibility criteria: Inclusion Criteria:

* patients will receive a Mayfield head-holder insertion for supratentorial craniotomy

Exclusion Criteria:

* History of chronic hypertension, Diabetes mellitus (DM), coronary heart diseases
* Receiving beta blockers
* BMI \> 30
* Coagulopathy
* severe liver and renal diseases

Primary outcomes:
measure: the change of SPI from baseline
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Dpt Anesthesiology, Faculty of Medicine, Chiang Mai University
name: Sirivimol Punjasawadwong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06024564: Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion
Official title: Sonu Real-World Use Clinical Study to Treat Moderate to Severe Nasal Congestion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nasal Congestion
Lead sponsor: Third Wave Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-09-06
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Real world utilization of Acoustic Resonance Therapy for symptoms of Nasal Congestion

Detailed description: This is an interventional study designed to gather data on real world utilization of Acoustic Resonance Therapy for treating moderate to severe nasal congestion

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Present with symptoms of chronic nasal congestion
* Have a 24 hour reflective nasal congestion subscore of the TNSS of 2 or more on a 0 to 3 scale at the time of screening

Exclusion Criteria:

* Head, nasal or sinus surgery within 3 months
* Pregnancy

Primary outcomes:
measure: Weekly Utilization-Frequency
timeFrame: 90 days
measure: Weekly Utilization-Duration
timeFrame: 90 days
Secondary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: 90 days
measure: Asthma Control
timeFrame: 90 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Otolaryngology Medical Group
state: California
Study officials:
affiliation: San Francisco Otolaryngology Medical Group
name: Jacob Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01617564: Paracervical Block During II-trimester Abortion
Official title: Paracervical Block (PCB) During II-trimester Abortion- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Second Trimester Medical Abortion
Keywords: medical abortion
second trimester
para cervical blockage
pain management
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Paracervical blockage can reduce severe pain during second trimester induced medical abortion.


Eligibility criteria: Inclusion Criteria:

* Women who request second trimester medical abortion (13-22 weeks gestation according to ultrasound)
* 18 years of age or older
* able to understand and communicate in Swedish
* able to understand the study related information and willing to give her
* informed consent to participation in the study

Exclusion Criteria:

* Known allergy to bupivakain or related substances

Primary outcomes:
measure: Pain score
timeFrame: at 24 hours
Secondary outcomes:
measure: Efficacy
timeFrame: after 24h from induction
measure: Time to abortion
timeFrame: at 24hours
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: at 6 to 8 weeks
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Dept of Obstetrics and Gynecology, Karolinska University Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Kristina Gemzell Danielsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson IM, Benson L, Christensson K, Gemzell-Danielsson K. Paracervical block as pain treatment during second-trimester medical termination of pregnancy: an RCT with bupivacaine versus sodium chloride. Hum Reprod. 2016 Jan;31(1):67-74. doi: 10.1093/humrep/dev286. Epub 2015 Nov 15.
Clinical trial NCT04668664: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Official title: PORTAL: Endoscopic Ultrasound-Guided Portosystemic Pressure Gradient Measurements
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Liver Diseases
Hypertension, Portal
Keywords: Fatty Liver
portal pressure measurement
portal pressure gradient
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2020-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cirrhosis referred for an EGD/ EUS

Brief summary: The objective of the study is to collect and report technical success of direct endoscopic ultrasound guided hepatic and portal vein pressure measurement obtained with EchoTip® Insight™ in patients with cirrhosis who are referred for an EGD and/or EUS.


Eligibility criteria: Inclusion Criteria:

Patient who has been referred for an EGD and/or EUS procedure and direct pressure measurement.

General Exclusion Criteria:

* Patient is pregnant, breast-feeding, or planning to become pregnant during the course of the study.
* Patient is unwilling or unable to sign and date the informed consent.
* Patient is unwilling or unable to comply with the follow-up study schedule.
* Patient for whom endoscopic procedures are contraindicated

Primary outcomes:
measure: Portal Pressure Gradient Measurement
timeFrame: once the measurement is calculated (approximately 1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: Kansas City
country: United States
facility: The University of Kansas Health System
state: Kansas
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: New York-Presbyterian Hospital/Weill Cornell University Medical Center
state: New York
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Herston
country: Australia
facility: Royal Brisbane Women's Hospital
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital/Chinese University of Hong Kong
Study officials:
affiliation: University of California, Irvine
name: Kenneth Chang, MD, FACG, FASGE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04984564: Cardiovascular Fellow-in-training Feedback on Virtual and Simulator-based Learning Experience in A Low to Middle Income Country
Official title: Cardiovascular Fellow-in-training Feedback on Virtual and Simulator-based Learning Experience During Covid-19 Pandemic in A Low to Middle Income Country
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Educational Problems
Keywords: cardiovascular education, virtual education, simulator, LMIC
Lead sponsor: Aga Khan University Hospital, Pakistan
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 68
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All fellow in training who were enrolled in a cardiovascular post graduate training program were invited to fill in GoogleForm survey.

Brief summary: Virtual and simulatorbased learning is not widely available in LMIC. It is imperative to analyze feedback of CV fellow-in-training regarding this mode of learning before large scale implementation.

Detailed description: COVID-19 pandemic has introduced us to a greater need of virtual learning platforms and has resulted in less clinical exposure for fellows-in-training. Virtual and simulatorbased learning is not widely available in LMIC. It is imperative to analyze feedback of CV fellow-in-training regarding this mode of learning before large scale implementation.

This was an observational study conducted between July-August 2020. A multicentered survey was conducted. Survey questionnaire was disseminated to FIT via Google Forms. The questionnaire contained total of 24 questions about virtual and simulator-based learning during the pandemic.

Eligibility criteria: Inclusion Criteria:

* Cardiovascular fellow-in-training currently under training at the institute.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Feedback of individual fellow in training on virtual and simulator based learning.
timeFrame: Survey was conducted from august to july 2020. Subjects had two month period to respond.
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Pirbhat Shams
state: Outside US And Canada
Study officials:
affiliation: The Aga Khan University Hospital
name: Pirbhat Shams, MBBS
role: PRINCIPAL_INVESTIGATOR
References: