louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06746597: Evaluating Skin Changes Using Optical Coherence Tomography on Plantar Layers
Official title: Evaluating Mechanical Properties Change Using Optical Coherence Tomography on Plantar Skin Layers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Thickness
Skin Stiffness
Keywords: OCT
skin thickness
skin stiffness
walking intervention
Lead sponsor: Asia University
Sponsor class: OTHER
First posted: 2024-12-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if there are changes in plantar skin surface walking intervention in different air-insole pressures and durations. The main questions it aims to answer are:

How far does walking intervention affect the changes in epidermis layers? What conditions affect the most in the plantar surface, the different air-insole pressures or the different durations?

Researchers will compare the use of three different air-insole pressures (80 mmHg, 160 mmHg, and 240 mmHg) in two different durations (10 and 20 minutes) to see how far the plantar skin surface changes in thickness and stiffness.

Participants will:

Get their plantar region checked and measured by Optical coherence tomography in thickness and stiffness before the walking intervention.

Walk with a custom-made shoe using adjusted air-insole pressures (80 mmHg, 160 mmHg, and 240 mmHg) in two different durations (10 and 20 minutes) Get their plantar region checked and measured by Optical coherence tomography in thickness and stiffness after the walking intervention.


Eligibility criteria: Inclusion Criteria:

* Right leg dominant
* Can walk without help

Exclusion Criteria:

* Active ulcers

Primary outcomes:
measure: Measurements of the Stratum Corneum and Deeper Epidermis are recorded in micrometers (for thickness) by comparing baseline values before walking to those obtained after the intervention.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Measurements of the Stratum Corneum and Deeper Epidermis are recorded in megapascal (MPa) or kilopascal (kPa) units (for stiffness) by comparing baseline values before walking to those obtained after the intervention.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Asia University
state: Wufeng
Study officials:
References:
Clinical trial NCT02759497: Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis
Official title: Evaluation of Serum Amyloid A in Early Diagnosis of Spontaneous Bacterial Peritonitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spontaneous Bacterial Peritonitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Decompensated cirrhosis with SBP Decompensated cirrhosis without SBP

Brief summary: One of the most common and serious complications in decompensated cirrhotic patients (DCPs) is bacterial infection.The most common infections in DCPs are cases of spontaneous bacterial peritonitis (SBP), which account for 40% 70% of cases, followed by urinary tract infections, pneumonia and cellulitis.

Serum amyloid A (SAA) and C-reactive protein (CRP) are acute-phase proteins predominantly produced and secreted by hepatocytes. Other cells including lymphocytes, monocytes, and macrophages can also produce these proteins. The induction of SAA and CRP synthesis is triggered by a number of cytokines, chiefly IL-6, which is released from a variety of cell types, but mainly from macrophages and monocytes at inflammatory sites

Detailed description: Increased serum CRP and SAA levels have been found in a number of disorders, including bacterial infections, malignancies tissue injuries and tissue rejection. Therefore, new studies of early diagnosis, prevention and treatment are needed to improve clinical outcomes.

Eligibility criteria: Inclusion Criteria:

* • Decompansated cirrhosis with ascites, defined by a combination of any of the following:

  * Laboratory findings
  * Endoscopic results
  * Ultrasound
  * Histology

Exclusion Criteria:

* Creatinine\>1.5 mg/dl
* Other infection e.grespiratory,UTI ,gastrointestinal and skin infection.
* Hepatocellular carcinoma
* Other extrahepatic malignancy e.g ; chest
* Any significant psychiatric illness or other medical comorbidity.
* Any degenerative diseases.

Primary outcomes:
measure: Number of patients with elevated serum amyloid A
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sherief Abd-Elsalam
Study officials:
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Rehab Badawi, Consultant
role: PRINCIPAL_INVESTIGATOR
affiliation: Division of Gastroenterology and Hepatology- Tanta
name: Sherief Abd-Elsalam, Consultant
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Walaa Elkhalawany, Consultant
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Reham Elkhouly, Consultant
role: STUDY_CHAIR
affiliation: clinical pathology dept.-Tanta
name: Mona Watany, Consultant
role: STUDY_CHAIR
affiliation: Hepatology and gastroenterology dept.-Tanta
name: Samah Soliman, Consultant
role: STUDY_CHAIR
affiliation: hepatology dept.-Tanta
name: Mai Khalaf, resident
role: STUDY_CHAIR
References:
Clinical trial NCT01412697: An Intervention Targeting Fruit and Vegetable Intake Among Rural Youth
Official title: Fruit and Vegetable Intake Among Rural Youth Following a School-based Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Imbalance of Constituents of Food Intake
Keywords: Rural youth
Theory-based intervention
Randomized by schools
Fruit and vegetable intake
Health classes
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2011-08-09
Enrollment: 1119
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators implemented a theory-based randomized controlled trial in ten rural Virginia middle schools in 2008-2010 and assessed the impact on health behaviors including fruit/vegetable intake as a primary outcome. Schools were randomized to intervention or control groups. Goal setting, peer leaders, and in-class workshops were intervention features. Seventh graders filled out surveys on health behaviors, psycho-social variables, and demographic characteristics. The investigators expected schools receiving the intervention to report a higher fruit-vegetable intake compared to control schools where students received standard health information. Sample (n=1,119) was 48.5% female, 50% White, with a mean age of 12.6 years. Fruit/vegetable intake was significantly higher in intervention schools at immediate post and at 1-year follow-up compared to controls.


Eligibility criteria: Inclusion Criteria:

* 7 grade youth
* attending participating middle schools

Exclusion Criteria:

* In grades other than 7th grade

Primary outcomes:
measure: Fruit and vegetable intake
timeFrame: Up to one year
Secondary outcomes:
measure: Confidence to increase fruit and vegetable intake
timeFrame: Up to one year
Other outcomes:
Locations:
city: Crewe
country: United States
facility: Nottoway Middle School
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Steven Danish, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilson DB, Jones RM, McClish D, Westerberg AL, Danish S. Fruit and vegetable intake among rural youth following a school-based randomized controlled trial. Prev Med. 2012 Feb;54(2):150-6. doi: 10.1016/j.ypmed.2011.11.005. Epub 2011 Dec 3.
Clinical trial NCT01104597: Study to Evaluate Subclinical Atherosclerosis (an Early Sign of Heart Disease) in Healthy Adult Immigrant Asian Indians
Official title: Assessment of Subclinical Atherosclerosis in Healthy Adult Immigrant Asian Indians Using Flow Mediated Endothelial Dysfunction Method
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Healthy
Keywords: Healthy Asian Indians and Caucasians
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Previous research has shown that Asian Indians are at relatively high risk for developing diabetes, heart problems and high blood pressure.

The purpose of this study is to evaluate subclinical atherosclerosis (an early sign of heart disease) which may be associated with abnormalities like diabetes mellitus, hypertension (high blood pressure), high cholesterol and heart problems.

Endothelium is the inner lining of your blood vessels. Endothelial dysfunction is found more in people with diabetes. In addition, high body mass index (BMI) is a strong risk factor for developing metabolic abnormalities like diabetes mellitus. This research study may provide information as to how useful endothelial dysfunction will be to detect people at risk of metabolic abnormalities and heart disease at an early stage.

Two groups of subjects will be enrolled. Caucasians and Asian Indians There will be a total of 100 subjects participating in this study. Approximately 50 Caucasians and 50 Asian Indians will be enrolled. Caucasians will serve as the control group for this study.


Eligibility criteria: Inclusion Criteria:

* Asian Indians and Caucasians between the ages of 20 and 65 living in the boroughs of New York City and the Long Island area.

Subjects must provide a record of blood results completed within the past year to determine eligibility (hematology and chemistry results).

Exclusion Criteria:

* Subjects with major underlying medical problems, including diabetes, hypertension, coronary artery disease (CAD), hyperlipidemia, systolic blood pressure below 90 mm Hg and liver or kidney disease will be excluded.

Primary outcomes:
measure: Assessment of subclinical atherosclerosis in healthy adult immigrant Asian Indians using flow mediated endothelial dysfunction method
timeFrame: April 2010 to April 2012
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Northwell Health
name: Rajiv Jauhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00121797: Peripartum Bacteruria and Urinary Tract Infections (UTI)
Official title: Risk Factors for Postpartum Bacteruria, Does Labor Cause UTI?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urinary Tract Infection
Keywords: Postpartum Period
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2005-07-21
Enrollment: 1000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In the last years urinary tract infections (UTI) and pyelonephritis have been the most common reason for readmission to our hospital after birth. UTI is know to be one of the leading causes of postpartum fever affecting about 3%-8% of all postpartum women.

The investigators hypothesize that collecting urine cultures pre- and postnatally may help identify women at risk for developing UTI, while treating women with positive cultures could decrease the rehospitalization rate due to postpartum fever. Collecting data during delivery may help identify women at risk for this complication.

Detailed description: The study is planned as a randomized controlled study with 500 women in each arm. The study group will have pre and post labor urine cultures taken, and the risk factors during delivery will be documented, while the control group will have no cultures taken, as the common practice prior to the study.

Women with positive cultures will be contacted by telephone, and antibiotic treatment recommended according to bacteria sensitivity. All women will be contacted by telephone 1 month post partum and data regarding urinary tract symptoms and need for hospitalization, will be collected. The rehospitalization rate will be documented and compared between the two groups.

The assumption is that routine urine culture to women in the peripartum period may reduce the UTI rate and hospitalization after delivery.

Eligibility criteria: Inclusion Criteria:

* Parturients planned for vaginal delivery

Exclusion Criteria:

* Parturients receiving antibiotic treatment during delivery or in the week before

Primary outcomes:
measure: Rate of rehospitalization for postpartum fever
measure: Incidence of UTI in the early puerperium
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Clinical microbiology, Hadassah Ein-Kerem Medical centre
city: Jerusalem
country: Israel
facility: Obs&Gyn Hadassah Ein-Kerem Medical center
Study officials:
affiliation: Hadassah Medical Organization
name: Tamar Elram, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01420497: Systemic Effects of Epidural Methylprednisolone Injection on Glucose Tolerance in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Healthy
Keywords: methylprednisolone
intra articular infiltration
glycemia
epidural infiltration
diabetes
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2011-08-19
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Several studies have shown that in diabetic patients, the glycemic profile was disturbed after intra-articular injection of corticosteroids. Little is known about the impact of epidural injection in such patients. The goal of this study was double, at first comparing the glycaemic profile in diabetic patients after a unique injection of 80 mg of acetate methylprednisolone either intra-articular or epidural, secondly to compare the amount of systemic diffusion of the drug the after both procedures.


Eligibility criteria: Inclusion Criteria:

* diabetes stable for more than ten days
* no contraindication for steroids
* lumbar stenosis
* articular pain

Exclusion Criteria:

* unstable diabetes
* renal insufficiency

Primary outcomes:
measure: glycemic values,
timeFrame: day 0 to day 15
Secondary outcomes:
measure: urinary excretion rate
timeFrame: day 0 to day 15
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUV
state: VD
Study officials:
References:
citation: Zufferey P, Bulliard C, Gremion G, Saugy M, So A. Systemic effects of epidural methylprednisolone injection on glucose tolerance in diabetic patients. BMC Res Notes. 2011 Dec 21;4:552. doi: 10.1186/1756-0500-4-552.
Clinical trial NCT01731197: Satiating Effects of Isolated Soy Proteins
Official title: Comparison of the Satiating Effects of Differentially Processed Isolated Soy Proteins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Management
Keywords: obesity, isolated soy protein, satiety, food intake
Lead sponsor: DuPont Nutrition and Health
Sponsor class: INDUSTRY
First posted: 2012-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Proteins are known to be more satiating than the other macronutrients; however, the type and amount of protein needed to induce a significant effect on satiety (fullness between meals) is sometimes difficult to determine. In this study, 2 differentially processed isolated soy proteins will be tested for satiety using subjective visual analogue scales. The amount of food consumed following intake of the isolated soy proteins will be measured 3 hours after consuming the proteins. The hypothesis is that differentially processed isolated soy proteins will show unique satiety responses.


Eligibility criteria: Inclusion Criteria:

* BMI between 20 and 30 kg/m2
* Age between 18-65y
* Unrestrained eater (score\<12)
* Regularly consume 3 meals per day
* Moderate exercise (eg running, aerobics classes, other sports activities) of no more than 7 hours per week

Exclusion Criteria:

* use of drugs that influence carbohydrate or lipid metabolism (eg. hypoglycemic agents, antibiotics taken less than 6 weeks before study entry, glucocorticoids, anti-diarrheal medication, weight loss medication, and anti-diabetic medication)
* presence of any significant disease (eg gastrointestinal diseases, diabetes, a CVD event less than 12 weeks from study entry, current hepatic disease, etc)
* use of special dietary treatments within 4 weeks of study (eg weight loss diet, extremely high or low carbohydrate/protein/fat diet, use of meal replacements more than once a day)
* use of supplements within 1 week of study (does not include vitamin supplements or supplements which are routinely taken and were initiated 4 weeks before the study and which will be continued during the study period)
* restrained eater (score\>12)
* weight change (absolute body weight change of ≥ 10%) within the previous 6 weeks
* alcohol intake \>2 drinks/day
* food allergies of any kind
* swallowing difficulties
* exercising more than 7 hours per week

Primary outcomes:
measure: Subjective Satiety
timeFrame: 3 hours
Secondary outcomes:
measure: Ad Libitum Food Intake
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Glycemic Index Laboratories
state: Ontario
Study officials:
affiliation: Glycemic Index Laboratories, Inc
name: Thomas Wolever, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glycemic Index Laboratories, Inc
name: Alexandra Jenkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02401997: The Effect of the Sexual Abstinence Period on the Production of Reactive Oxygen Species in Patients Who Planned to Take Part in Intrauterine Insemination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxidative Stress
Keywords: sperm
oxidative stress
sexual abstinence
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 90
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To determine the ideal sexual abstinence time for producing high quality sperm


Eligibility criteria: Inclusion Criteria:

* Patients who had made an application to Gazi University Obstetrics and Gynecology clinic for infertility and planned to have IUI (intrauterine insemination)

Exclusion Criteria:

* Erectile dysfunction- improper semen collection

Primary outcomes:
measure: Effect of sexual abstinence period on oxidative stress status of seminal plasma collected for homologous artificial insemination
timeFrame: 0-2 days vs 2-4 days vs 4-6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Obstetrics and Gynecology Clinic
Study officials:
References:
Clinical trial NCT05163197: Transperineal Laser Ablation Treatment (TPLA) for Prostate Cancer (PCa) Registry
Official title: Transperineal Laser Ablation Treatment for Prostate Cancer Registry: a Retrospective and Multicenter Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Laser Ablation
Minimal invasive
Focal therapy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2021-12-20
Enrollment: 200
Sex: MALE
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: The registry population comprises those patients that have been treated with TPLA for PCa.

Brief summary: Rationale: Transperineal laser ablation (TPLA) treatment for prostate cancer (PCa) is a minimal invasive focal therapy technique studied worldwide to determine its efficacy. In pilot studies it has shown to be a safe and feasible technique and it has potential to preserve continence and potency over current standard radical therapies. However, (long-term) treatment outcomes of TPLA for PCa remain largely unknown. The aim of this international retrospective registry is to collect and combine data on patients treated TPLA for PCa in order to provide data on safety, feasibility, functional and oncological outcomes.

Objective: To assess safety and feasibility of TPLA for PCa, to assess functional and oncological outcomes of TPLA for PCa and to determine baseline patient characteristics in a multicentre cohort.

Study design: This is an international, retrospective observational registry in which data is recorded of patients who have been treated with TPLA for PCa.

Study population: Male patients treated with TPLA for PCa. Main study parameters/endpoints: The primary endpoint of this registry is oncological outcomes of TPLA for PCa. Secondary endpoints are safety, feasibility and functional outcomes of TPLA for PCa.


Eligibility criteria: Inclusion Criteria:

* Male, histological-confirmed disease of localized prostate cancer, TPLA treatment for PCa is performed

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Oncological control
timeFrame: 12 months
Secondary outcomes:
measure: Continence rate
timeFrame: 12 months
measure: Potency rate
timeFrame: 12 months
measure: Urinary flow
timeFrame: 12 months
measure: PROM regarding voiding
timeFrame: 12 months
measure: PROM regarding erectile function
timeFrame: 12 months
measure: Safety of TPLA for PCa
timeFrame: Up to 12 weeks
measure: Feasibility of TPLA for PCa
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
Study officials:
affiliation: Principal Investigator
name: J. R. Oddens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: