louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05223153: OCT-A and Amblyopia
Official title: Assessment of Macular Microvascular Changes Following Amblyopia Treatment in Children With Anisometropic Amblyopia Using Optical Coherence Tomography Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amblyopia
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-02-03
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with unilateral anisometropic amblyopia without previous treatment with glasses or patches

Brief summary: Detect changes in retinal vessel density in the superficial and deep capillary plexuses using OCTA in children with anisometropic amblyopia


Eligibility criteria: Inclusion Criteria:

1. Unilateral anisometropia.
2. Refractive error less than -6.00 D and +4.00 D.
3. Age less than 12 years.
4. No previous amblyopia treatments

Exclusion Criteria:

1. High refractive error. 2. Bilateral amblyopia. 3. Age more than 12 years.

-

Primary outcomes:
measure: Change in retinal vessel density
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine- Minia University
Study officials:
References:
Clinical trial NCT06039553: Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
Official title: A Comprehensive Research of Pediatric Heart Failure -- A Self-control Study of Pulmonary Artery Banding for the Improvement of Left Ventricular Function in Pediatric Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure Congenital
Keywords: congenital heart disease
pulmonary artery banding
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Peking University First Hospital
name: Beijing Children's Hospital
First posted: 2023-09-15
Enrollment: 25
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: paitent younger than 14 years of age with heart failure

Brief summary: The goal of this observational study is to learn about the safety and effectiveness of pulmonary artery banding(PAB) therapy in pediatric heart failure(PHF) patients.

The main questions it aims to answer are:

* Can PAB therapy improve left ventricular(LV) function in PHF patients especially refractory PHF.
* Can the complications caused by the PAB therapy be clinically acceptable? Participants underwent PAB therapy will be required to underwent echocardiography, electrocardiograms, complete blood counts, biochemical tests, and measurements of N-terminal pro-brain natriuretic peptide (NT-proBNP) follow-up before the initiation of PAB and at 1 month, 3 months, and 6 months after PAB surgery. Researchers will compare the LV function 6 months after PAB suergey and the preoperative ones to see if there is improvement.


Eligibility criteria: Inclusion Criteria:

* patients younger than 14 years of age
* congenital heart failure (LVEF\<55%, or LVFS\<25%)

Exclusion Criteria:

* single ventricle
* congenital heart disease without anatomical correction
* Patients with heart failure requiring ventricular assist or cardiac synchronization therapy
* Patients with severe pulmonary hypertension (pulmonary arterial pressure \>6 Wood·U)
* Patients with severe liver and kidney failure
* Patients who are allergic to related medications
* Patients with symptomatic hypotension who cannot tolerate related drugs
* Refuse to sign the informed consent or refuse to participate in this experiment

Primary outcomes:
measure: the recurrence rate of heart failure
timeFrame: after 6 months of PAB surgery
Secondary outcomes:
measure: NT-proBNP level
timeFrame: after 6 months of PAB surgery
measure: Incidence rate of drug adverse reactions
timeFrame: after 6 months of PAB surgery
measure: Readmission rate for heart failure
timeFrame: after 6 months of PAB surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shoujun Li, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05801653: Health Effects of Oat Bioactives (Betaglucan) in Human
Official title: Health Effects of Oat and Oat Bioactives in Human
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Lund University
Sponsor class: OTHER
Collaborators: name: Swedish Foundation for Strategic Research
First posted: 2023-04-06
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Aim of the study is to investigate health effects of oats and oat derived components, in human intervention studies, with the purpose to build new knowledge for development of cardiometabolic protective foods.

Detailed description: The overall goal is to increase the knowledge which can be used for the development of food products with anti-diabetic properties, with the purpose to facilitate healthier food choices for people. More specifically the primary purpose of this project is to evaluate effects in healthy humans on cardiometabolic test markers of oat and oat based product. The new knowledge will form a base for the development of oat based food products with added health values.

Eligibility criteria: Inclusion Criteria:

- Healthy adults BMI 18.5 - 28 Kg/m2 Non smokers Consuming a non-vegetarian diet that follows the Nordic diet recommendation.

Exclusion Criteria:

- Fasting blood glucose concentration \>6.1 mmol/l Known cardio-metabolic disease (e.g. diabetes, hypertension, metabolic syndrome).

Gastro-intestinal disorders such as IBS (irritable bowel syndrome) that can interfere with the study results, food allergies.

No antibiotics or probiotics should have been consumed within 4 weeks prior to and during the study.

Primary outcomes:
measure: Blood glucose regulation
timeFrame: Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Secondary outcomes:
measure: Serum insulin
timeFrame: Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Other outcomes:
measure: Subjective appetite sensations
timeFrame: Time Frame: 0 - 5.5 hours ( at fasting and then repeatedly after breakfast and Standardize lunch)
Locations:
city: Lund
country: Sweden
facility: Food Technology, engineering and Nutrition, LTH, Lund University
state: Skane
Study officials:
affiliation: Department of Food Technology, Engineering and Nutrition, Lund Univesity
name: Anne Nilsson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06397053: Comparison of Robotic Versus Laparoscopic Surgery for Visceral Obesity in Mid-Low Rectal Cancer: A Propensity-Matched Analysis
Official title: Comparison of Robotic Versus Laparoscopic Surgery for Visceral Obesity in Mid-Low
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visceral Obesity
Rectal Cancer
Robotic Surgery
Lead sponsor: Northern Jiangsu People's Hospital
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective investigation included participants who experienced anterior rectal resection using robotic or laparoscopic techniques at the General Surgery Department of Northern Jiangsu People's Hospital between December 2019 and October 2023.

Brief summary: Our team has previously published articles providing detailed descriptions of the steps involved in both RS and LS. All surgeries adhered to the total mesorectal excision (TME) principle. In RS, a surgeon employed the Da Vinci Xi surgical system featuring a five-port setup, while five physicians conducted LS with a similarly configured five-port approach. Both the RS and LS doctors are experienced. The surgeries were conducted according to standard procedures, and the RS group utilized totally robotic rectal resection.


Eligibility criteria: Inclusion Criteria:

(1) confirmed pathology of mid-to-low rectal cancer (within 10 centimeters from the anal margin); (2) availability of comprehensive pathological and computed tomography (CT) data; (3) presence of a diagnosis indicating visceral obesity.

Exclusion Criteria:

Multiple tumor

Primary outcomes:
measure: early postoperative problems
timeFrame: 2019-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT03607253: Muscle Fatigue and Foot Biomechanics
Official title: Investigating the Gender-related Response of Muscle Fatigue of the Medial Longitudinal Arch Height in Healthy Young
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot, Flat
Keywords: medial longitudinal arch
foot
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Medial longitudinal arch (MLA) is a curve of the foot located at the medial side of the body and protection of the height of the MLA is an important factor for limb health.

This study was planned with the aim of investigating the response of the MLA height to the repetitive muscle activity and determine the gender-related differences.


Eligibility criteria: Inclusion Criteria:

* healthy young females and males who want to participate to the study

Exclusion Criteria:

* have orthopedic, physiologic, psychiatric, neurologic or systemic disorders
* have present medication

Primary outcomes:
measure: Navicular Drop
timeFrame: at first minute, change from baseline arch height at 2nd minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Edirne
country: Turkey
facility: Trakya University
Study officials:
References:
Clinical trial NCT00216853: A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection
Official title: A Study of Vaginal MicroFlora and Immune Profiles of Patients With Recurrent Urinary Tract Infection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infections
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2005-09-22
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE

Brief summary: The purpose of this study is to determine the extent to which vaginal microflora and immune profiles of patients with urinary tract infection (UTI) differ from healthy controls.

Detailed description: Recurrent urinary tract infections, which occur mostly in the female population, can be potentially harmful if not treated and significantly reduce quality of life. By characterizing the vaginal microflora and immune profiles of women that suffer recurrent UTIs in contrast to a healthy age matched normal group of women (with no history of recurrent UTIs), we can better understand the differences. This in turn can lead to development of better quality probiotics that will be based on their scientific basis, clinical efficacy, and quality in terms of shelf life and delivery to target sites. The reduction in only one third of UTI cases seen each year would have a significant impact on reducing health care costs.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria for UTI Group:

1. At least 2 recurrent UTIs within the last year
2. Written informed consent

Inclusion Criteria for Normal Group:

1. No UTI within the past 5 years
2. Written informed consent

Exclusion Criteria:

Exclusion Criteria for Both Groups:

1. Active UTI
2. Urinary tract anomalies
3. Evidence of a neurogenic bladder
4. Known immunodeficiencies
5. Use of antibiotics, within the last month
6. Concomitant use of oral steroids
7. Known renal calculi
8. Previous or ongoing chemotherapy
9. Pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Stephen Pautler, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00522353: Prebiotic Fiber as a Modifier of Satiety Hormones and Body Weight in Overweight and Obese Adults
Official title: Effect of Oligofructose Versus Placebo on Body Weight and Satiety Hormone Secretion in Overweight and Obese Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
weight loss
satiety hormones
body composition
appetite ratings
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2007-08-29
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if oligofructose supplementation promotes weight loss in overweight and obese adults.

Detailed description: Obesity is a primary health concern for many western countries as it is linked to several chronic diseases as well as, large health care costs. Although obesity is a multifactorial disease, it is known that levels of satiety hormones including glucagon like peptide-1 (GLP-1) and peptide YY (PYY) are reduced in obesity. The ability of prebiotic fiber to promote weight loss through the production of satiety hormones has been tested previously using rodents. Here it was found that prebiotic supplementation resulted in a decreased energy intake, higher GLP-1 levels in the plasma and increased proglucagon mRNA levels in the gut. This study will address the important question of whether prebiotic fiber supplementation is effective in reducing body weight in overweight or obese human subjects.

Eligibility criteria: Inclusion Criteria:

* overweight or class I obese individuals with BMI between 25 kg/m2 and 34.9 kg/m2
* stable body weight in previous 3 months

Exclusion Criteria:

* Type 1 and Type 2 diabetes
* clinically significant cardiovascular abnormalities
* liver or pancreas disease
* major gastrointestinal surgeries
* are pregnant or lactating
* exhibit alcohol or drug dependence
* on drugs influencing appetite
* are following a diet or exercise regime designed for weight loss
* have a body mass greater than 350lb
* chronic use of antacids or bulk laxatives

Primary outcomes:
measure: Body weight
timeFrame: 3 months
Secondary outcomes:
measure: Plasma satiety hormones
timeFrame: 3 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Faculty of Kinesiology, Roger Jackson Centre for Health and Wellness Research
state: Alberta
Study officials:
affiliation: University of Calgary
name: Raylene A. Reimer, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Parnell JA, Klancic T, Reimer RA. Oligofructose decreases serum lipopolysaccharide and plasminogen activator inhibitor-1 in adults with overweight/obesity. Obesity (Silver Spring). 2017 Mar;25(3):510-513. doi: 10.1002/oby.21763.
citation: Parnell JA, Reimer RA. Weight loss during oligofructose supplementation is associated with decreased ghrelin and increased peptide YY in overweight and obese adults. Am J Clin Nutr. 2009 Jun;89(6):1751-9. doi: 10.3945/ajcn.2009.27465. Epub 2009 Apr 22.
Clinical trial NCT02461953: Combination of Hemodialysis With Hemoperfusion：A Clinical Study
Official title: HA130 Hemoperfusion Apparatus Combined Hemodialysis to Improve Quality of Life in Patients Undergoing Maintenance Hemodialysis：A Perspective, Randomized, Controlled Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Dialysis
Hemoperfusion
Quality of Life
Keywords: hemodialysis
hemoperfusion
quality of life
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 440
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study is a prospective, randomized, controlled multicenter clinical study. The aim of the study is to investigate whether the combination of maintenance hemodialysis (MHD) with hemoperfusion (HP) could improve the clearance rate of middle and large molecule uremic toxins so as to improve the quality of life of MHD patients and reduce their mortality rate.


Eligibility criteria: Inclusion Criteria:

1. Age≥18, male or female
2. Maintenance hemodialysis duration\>3 months
3. Regular hemodialysis,3 times a week,4 hours per session
4. Vascular access unlimited
5. iPTH≥300pg/ml
6. Sign the written informed consent

Exclusion Criteria:

1. Allergic to dialysis equipment
2. PLT\<60×10\^9/L
3. Blood flow\<200ml/min
4. Serum albumin\<30g/L
5. Kt/V\<1.2
6. iPTH\>800pg/ml
7. Hemodiafiltration
8. Coagulation disorder, severe bleeding tendency, with active bleeding
9. Severe hypotension, severe cardiopulmonary insufficiency
10. Under other drug trial
11. Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor

Primary outcomes:
measure: Clearance rate of uremic toxins
timeFrame: 0,3,6,12 months
Secondary outcomes:
measure: Evaluation of quality of life
timeFrame: 0,3,6,12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03755453: Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application - Sonova2018_34
Official title: Assessment of Novel Measurement and Fitting Methods to Determine Their Reliability, Validity and Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Sonova AG
Sponsor class: INDUSTRY
First posted: 2018-11-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive a hearing aid fitted with fitting method A and afterwards fitted with fitting method B.
Primary purpose: TREATMENT

Brief summary: A methodical evaluation of novel measurement and fitting methods for individualizing CE-labelled Sonova brand hearing instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired participants. The aim of the study is to investigate and asses strength and weaknesses of these novel measurement and fitting methods in terms of optimizing hearing performance and experience and/or usability of the hearing aids and accessories. Both laboratory measurements as well as evaluations in real life environments will be carried out. This will be a controlled and randomised active comparator clinical evaluation which will be conducted mono-centric at Sonova AG Headquarter based in Stäfa.


Eligibility criteria: Participants fulfilling all of the following inclusion criteria are eligible for the study:

* Adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids
* Healthy outer ear (without previous surgical procedures)
* Ability to fill in a questionnaire (p/eCRF) conscientiously
* Informed Consent as documented by signature

The presence of any one of the following exclusion criteria will lead to exclusion of the participant:

* Contraindications to the MD in this study, e.g. known hypersensitivity or allergy to the investigational product
* Limited mobility and not in the position to attend appointments
* Limited ability to describe listening impressions or to use hearing aids/ accessories
* Inability to produce a reliable hearing test result
* Massively limited dexterity
* Known psychological problems
* Known central hearing disorders

Primary outcomes:
measure: Comparison of fitting method A versus B in regard to sound quality
timeFrame: 2 months
Secondary outcomes:
measure: Comparison of fitting method A versus B in regard to speech intelligibility in noise
timeFrame: 2 months
Other outcomes:
Locations:
city: Stäfa
country: Switzerland
facility: Sonova AG
state: Zürich
Study officials:
References:
Clinical trial NCT00959153: Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney
Official title: Extracorporeal Shock Wave Lithotriptor Indicated for Fragmenting Urinary Stones in the Kidney (Renal Pelvis)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Kidney Stones
Keywords: Fragmenting of kidney stones
extracorporeal shockwave lithotripsy
Lead sponsor: Advance Shockwave Technology GmbH
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A total of 20 subjects presenting with urinary stone(s) in the kidney or ureter will be treated with an extracorporeal shockwave lithotripsy device to fragment the stones. Subjects will be followed for 14 days. If at the 14 day follow-up visit the subject continues to present with a stone size 4 mm or greater will have an option of retreatment or other intervention. If the subject consents to be retreated at this time, this subject will be followed up for another 14 days.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a solitary Urinary stones in the renal pelvis or renal calyces or ureter
* Presence of one stone greater than 4 mm and less than 12 mm

Exclusion Criteria:

* Urinary tract obstruction, acute or unresolved cholecystitis, cholangitis, pancreatitis or obstruction of the biliary duct system
* Impaction of stone to be treated
* Staghorn stones
* Failed or inadequate lithotripsy procedure within 3 months prior to study
* Coagulation abnormalities or anticoagulation therapy
* Pregnant or females of child-bearing potential General, spinal or epidural anesthesia is contraindicated
* Can not be positioned correctly for fluoroscopic imaging

Primary outcomes:
measure: stone fragmentation
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Garden City
country: United States
facility: Metropolitan Lithotriptor Associates
state: New York
city: New York
country: United States
facility: Allied Urological Services, LLC
state: New York
Study officials:
References: