louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06558461: Nebulised 3% Hypertonic Saline in Infants With Acute Bronchiolitis
Official title: Evaluating the Efficacy of Nebulised 3% Hypertonic Saline for Acute Bronchiolitis in Infants: A Study at Can Tho Children's Hospital, 2022-2024
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Bronchiolitis
Keywords: Bronchiolitis
3% hypertonic saline
Lead sponsor: Can Tho University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 140
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled open-label parallel-arm clinical trial, with allocation 1:1, was conducted to investigate whether nebulizing 3% hypertonic saline will improve clinical symptoms and reduce the length of hospital stay in bronchiolitis compared with the control group.
Primary purpose: TREATMENT

Brief summary: This study aims to determine the efficacy of nebulising 3% hypertonic saline in improving clinical symptoms and reducing the length of hospital stay in infants with acute bronchiolitis.

Detailed description: Bronchiolitis is the most prevalent disease in infants, especially children younger than two years old. Clinical manifestations vary from mild to severe, even life-threatening respiratory failure. Airway oedema and mucus plugging are the principal pathological features in infants with acute bronchiolitis. Nebulising 3% hypertonic saline solution may reduce these pathological changes, but the evidence remains equivocal.

Eligibility criteria: Inclusion Criteria:

* Pediatric patients diagnosed with acute bronchiolitis from 1 to 24 months old at Can Tho Children's Hospital.

Exclusion Criteria:

* Family members do not agree to let the child participate in the study.
* Severe respiratory failure required mechanical ventilation.
* The patient left on his own during treatment.

Primary outcomes:
measure: Improve clinical severity score after three days of treatment with nebulized 3% hypertonic saline.
timeFrame: three days
Secondary outcomes:
measure: Shorten the mean length of hospital stays in infants with bronchiolitis after treatment with nebulized 3% hypertonic saline.
timeFrame: From admission to discharge, up to 14 days
Other outcomes:
Locations:
city: Can Tho
country: Vietnam
facility: Can Tho Children's Hospital
Study officials:
affiliation: Can Tho University of Medicine and Pharmacy
name: Van VuTuong Le, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05258461: An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy
Official title: An Innovative Smartphone Application for Adverse Event Management During Breast Cancer Adjuvant Chemotherapy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Application
Adverse Event
Quality of Life
Chemotherapy
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate benefits of the app in breast cancer patients receiving the docetaxel, doxorubicin, and cyclophosphamide (TAC) chemotherapy. The investigators hypothesized that the addition of the app to conventional adverse event management would increase quality of life (QoL) scores and reduce adverse events.


Eligibility criteria: Inclusion Criteria:

1. pathological diagnosis of invasive breast cancer
2. breast surgery within the past 2-8 weeks
3. adult female
4. must be able to use mobile phones
5. speak and write Chinese fluently to sign the informed consent

Exclusion Criteria:

1. severe comorbidity that interferes with outcome evaluation
2. insufficient Chinese language skills
3. inability to use mobile phones
4. cognitive disability to give informed consent

Primary outcomes:
measure: Change from baseline quality of life scores at 4 months
timeFrame: 1 day before the first cycle, and 4 months after the first cycle (each cycle is 21 days)
Secondary outcomes:
measure: Incidence and severity of 12 common adverse events
timeFrame: 4 months after the first cycle (each cycle is 21 days)
Other outcomes:
measure: Login times
timeFrame: Documented automatically by the application every two weeks
measure: Average time spent on the application
timeFrame: Documented automatically by the application every two weeks
measure: Questions addressed on the Q&A platform
timeFrame: Documented automatically by the application every two weeks
Locations:
Study officials:
affiliation: Department of Breast Surgery, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences
name: Yan Li, Doctor
role: STUDY_DIRECTOR
References:
citation: Cheng JX, Liu BL, Zhang X, Zhang YQ, Lin W, Wang R, Zhang YQ, Zhang HY, Xie L, Huo JL. The validation of the standard Chinese version of the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC QLQ-C30) in pre-operative patients with brain tumor in China. BMC Med Res Methodol. 2011 Apr 22;11:56. doi: 10.1186/1471-2288-11-56.
citation: Wan C, Meng Q, Yang Z, Tu X, Feng C, Tang X, Zhang C. Validation of the simplified Chinese version of EORTC QLQ-C30 from the measurements of five types of inpatients with cancer. Ann Oncol. 2008 Dec;19(12):2053-60. doi: 10.1093/annonc/mdn417. Epub 2008 Jul 24.
Clinical trial NCT05965661: A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease
Official title: A New 3D Virtual Reality-based Upper Limb Training to Improve Dexterity in Parkinson's Disease: a Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
virtual reality training
dexterity
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized pilot study
Primary purpose: TREATMENT

Brief summary: We investigate the impact of a 4-week virtual reality-based upper limb training in Parkinson's disease. The benefits on dexterity of this training program will be evaluated.

For these purposes, a randomised, two arm, single assessor blind, parallel design with a monocentric, study setup will be performed.

Detailed description: Patients with Parkinson's disease (PD) suffer from significantly decreased coordination and have difficulties with precise hand/finger movements during the performance of both basic activities of daily living (ADL), such as dressing, grooming as well as higher ADL, such as cooking, shopping and regular medication intake. These difficulties further add to the burden of the disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing aspect of training in PD neurorehabilitation offers virtual reality (VR). We explore the effects of a VR-based upper limb hand training compared to a VR control training, which is less specific for dexterity. Moreover, we examine the effetcs of the trainings on upper limb related ADL, and therefore the impact on QoL in patients with PD.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed PD, according to UK Brain bank Criteria
* Hoehn \& Yahr Stadium I to IV
* Age 40 to 99 years
* written and signed informed consent
* self-reported dexterous difficulties

Exclusion Criteria:

* MoCA \<21/30
* psychiatric disease
* participation on other interventional trials
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
* severe visual impairment

Primary outcomes:
measure: fine finger movements
timeFrame: 4 weeks
Secondary outcomes:
measure: hand dexterity
timeFrame: 4 weeks
measure: grip strenght
timeFrame: 4 weeks
measure: motor function
timeFrame: 4 weeks
measure: self-reported dexterity related problems in daily living
timeFrame: 4 weeks
measure: self-reported problems in quality of life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lucerne
country: Switzerland
facility: Luzerner Kantonsspital
Study officials:
affiliation: Luzerner Kantonsspital
name: Tim Vanbellingen, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00843661: Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients
Official title: Coadministration of Ezetimibe With Fenofibrate Versus Pravastatin Monotherapy for the Treatment of Hyperlipidaemia in HIV-infected Patients Receiving Protease Inhibitors: a Randomized, Prospective, Controlled Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: HIV
Hyperlipidemia
HIV Infections
Keywords: Treatment Experienced
Lead sponsor: Ospedale di Circolo - Fondazione Macchi
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-02-13
Enrollment: 60
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: * The aim of the study is to compare the effects of coadministration of ezetimibe 10 mg/die + fenofibrate 200 mg/die versus pravastatin 40 mg/die monotherapy in HIV-infected patients treated with protease inhibitors.
* Single-centre, open, randomized, controlled, prospective pilot study.
* 60 patients will be enrolled in order to reach the target of 50 patients evaluable at the end of the study. The patients will be randomly assigned to a 6-month treatment with ezetimibe+fenofibrate or with pravastatin.The visit will be every month.


Eligibility criteria: Inclusion Criteria:

* patients older than 18 years
* documented positive HIV antibodies test
* on stable therapy with PIs for at least 12 months
* LDL-cholesterol \>130 mg/dl or triglycerides 200 - 500 mg/dl with non-HDL cholesterol \>160 mg/dl
* unresponsive to dietary measures and regular physical exercise of at

Exclusion Criteria:

* history of dyslipidemia before antiretroviral therapy
* cardiovascular and cerebrovascular diseases
* Cushing's syndrome
* concurrent therapy with lipid-lowering agents, oral anticoagulant, estrogens, thiazidic diuretics, beta-blockers
* hypothyroidism
* Type 1 diabetes mellitus
* renal failure

Primary outcomes:
measure: per cent changes of LDL cholesterol, comparison between the 2 treatment regimens
timeFrame: After 6 month treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Ospedale di Circolo and Fondazione Macchi
Study officials:
References:
Clinical trial NCT00705861: Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
Official title: A 12 Week, Multi-center, Randomized, Double Blinded, Placebo-controlled, Parallel Group, Fixed Dose Study to Assess the Efficacy and Safety of SK3530 on Erectile Dysfunction in Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction
Diabetes Mellitus
SK3530
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 112
Sex: MALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.

Detailed description: SK3530 is a potent and selective phosphdiesterase type 5(PDE 5) inhibitor developed for the treatment of erectile dysfunction(ED). Since ED is common in men with Diabetes Mellitus, it is important to determine the efficacy and safety of SK3530 on erectile dysfunction in Patients with Diabetes Mellitus.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of type 1 or type 2 diabetes.
* Score below 25 from IIEF EF domain during 4 weeks of treatment run-in period.
* Failure rate above 50% from sexual attempt above 4 during 4 weeks of treatment run-in period.

Exclusion Criteria:

* Lab abnormality.
* Uncontrolled diabetic mellitus(HbA1c \> 12%).
* High or low blood pressure, orthostatic hypotension.
* Hyper- or hypo-thyroidism.

Primary outcomes:
measure: Erectile Function domain score (sum of Question 1,2,3,4,5 and 15) of the International Index of Erectile Function (IIEF) Questionnaire
timeFrame: 0, 4, 8, 12week
Secondary outcomes:
measure: the score from : 1) IIEF Q3 & Q4, 2) other domains of IIEF, 3) Sexual Encounter Profile(SEP)Q2 and Q3, 4) Life Satisfaction Checklist, 5) Global Efficacy Assessment Question(GEAQ)
timeFrame: 0, 4, 8, 12 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SK Chemicals Co., Ltd
Study officials:
affiliation: BNUH
name: Nam-Chul Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06752161: Urinary Infection in Pregnant Women with Urinary Infection
Official title: Urinary Tract Infections in Patients with Threatened Preterm Labor
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Threatened Preterm Labour
Keywords: UTI
Preterm labour
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-12-30
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with threatened preterm labor

Brief summary: Urine analysis and culture in patients with threatened preterm labour

Detailed description: UTI is an infection of the kidneys, bladder, or urethra. Infectious cystitis is the most common type of UTI, which is caused by a bacterial infection of the bladder. Lifetime incidence of UTIs is 50% to 60% in adult women.UTIs are among the most common conditions encountered in primary care, hospitals, and extended care facilities . Total direct costs of UTI treatment (without cultures) have been estimated at US $25.5 billion annually.Despite an exceptionally high prevalence of bacteriuria in the population, these infections rarely cause significant renal damage.Sexual intercourse is the strongest risk factor. Any lifetime sexual activity and any sexual activity during the past year are strongly associated with recurrent UTI. Even the relatively small amounts of spermicide coating condoms increases the risk of UTI. Post-menopausal absence of oestrogen is a risk factor for UTIs. Topical oestrogen reduces UTIs in post-menopausal women; Oestrogenisation of the vaginal mucosa promotes lactobacilli colonisation, which reduces the presence of uropathogens and thus the risk of UTIs and is not recommended over the use of topical oestrogen therapy. Urinary incontinence and oestrogen supplementation have also been associated with UTI in older women, although the reasons for this are incompletely understood. positive family history of UTIs is associated with a two- to fourfold increase in risk of recurrent UTI . Bacteriuria occurs in the presence of indwelling or intermittent catheters, and asymptomatic bacteriuria does not require treatment. Gestational and pregestational diabetes are considered a more predominant risk factor in older women.

Eligibility criteria: Inclusion Criteria:

* pregnant women with preterm labor

Exclusion Criteria:

* renal disease Intrauterine fetal death

Primary outcomes:
measure: percent of urinary tract infections in threatened preterm labor
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Women's Health Hospital
Study officials:
affiliation: Women's Health Hospital Resident
name: Mohammed Seif al nasr, MBBCH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03064061: Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate
Official title: Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
in Vitro Fertilization
Virtual Reality
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-02-24
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.


Eligibility criteria: Inclusion Criteria:

* Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.
* Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)

Exclusion Criteria:

* Patients with long-term psychotherapeutic treatment
* Patients taking psychotropic drugs
* patient blind and deaf

Primary outcomes:
measure: impact of the virtual reality on the pregnancy rate (Ultrasound)
timeFrame: 12 weeks
Secondary outcomes:
measure: impact of the virtual reality on anxiety (numeric scale)
timeFrame: immediate
measure: impact of the virtual reality on satisfaction
timeFrame: immediate
measure: impact of the virtual reality on pregnancy test
timeFrame: 6 weeks
measure: state-trait Anxiety Inventory
timeFrame: immediate
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-luc
Study officials:
References:
Clinical trial NCT05197361: Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
Official title: Evolución de Las Resistencias Microvasculares y Del Flujo Coronario Absoluto en Pacientes Con intervención Coronaria percutánea de Una oclusión crónica
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Total Occlusion of Coronary Artery
Microvascular Coronary Artery Disease
Coronary; Ischemic
Coronary Microvascular Dysfunction
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ischemic heart disease and evidence of at least one chronic total occlusion, with data of inducible ischemia and/or viability and susceptible to percutaneous coronary intervention.

Brief summary: It is an observational study which objective is to analyze, through a series of invasive parameters, the state of the coronary microvasculature immediately after the successful percutaneous coronary intervention of a chronic total occlusion and at 6 months after the index procedure.

The aim of the study is to check the variation in the values of the index of microcirculatory resistance (IMR) and invasive absolute coronary flow (AF). The working hypothesis is that, in the follow-up of these patients, AF will increase significantly with respect to its baseline and, conversely, IMR will be reduced during the follow-up.


Eligibility criteria: Inclusion Criteria:

* Those patients with a clinical indication for percutaneous coronary intervention of a chronic total occlusion. As a routine clinical practice in our center, it is proposed to perform a angiographic follow-up 6 months after the index procedure.

Exclusion Criteria:

* No specific exclusion criteria.

Primary outcomes:
measure: Variation in the values of IMR between basal and 6-months follow-up
timeFrame: 6 months
measure: Variation in the values of absolute coronary flow between basal and 6-months follow-up
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
Study officials:
References:
Clinical trial NCT06808061: Effects of Lactobacillus Plantarum KABP-51 Probiotic on Body Composition, Microbiome and Mood in Healthy Overweight Adults
Official title: Effects of Kaneka KABP-51 Probiotic on Mood, Metabolism, Microbiome, and Body Composition in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Mood
Keywords: microbiome
probiotic
psychobiotic
weight loss
body composition
obesity
depression
dysbiosis
Lead sponsor: 3 Waves Wellness
Sponsor class: INDUSTRY
Collaborators: name: Kaneka Americas Holding Inc.
First posted: 2025-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to recruit 60 healthy moderately overweight subjects to participate in a research study investigating the effects of a specific probiotic strain (Lactobacillus plantarum KABP-51) on measures of psychological mood state, gut microbiome status, stress hormones, and body composition (body fat and muscle mass).

Our subjects will be measured 4 times over the course of a 12-week supplementation period - at Baseline, Week 4, Week 8, and Week 12.

We will have 2 groups (N=30 per group):

* Probiotic Lactobacillus plantarum KABP-51
* Placebo (maltodextrin/corn starch) Subjects will be recruited from local fitness/wellness centers and businesses (e.g. Plymouth Fitness; Planet Fitness; Marathon Sports, etc) using a simple flyer.

If volunteers meet the inclusion/exclusion criteria, they will review/sign the Informed Consent Form (ICF) before any Baseline measurements are collected.

Participants will meet weekly (via online webinar) for educational sessions on nutrition, exercise, sleep, stress, and related healthy lifestyle topics. This periodic contact is extremely effective for maintaining compliance with the supplementation regimen and reducing dropouts.

Our expectation is that this fairly simple 12-week design will show that the KABP-51 probiotic strain can support a variety of psychological benefits such as reduced stress and improved mood; as well as physical benefits such as improved stress hormone exposure and microbiome balance - all of which may lead to improved body composition (lower body fat and improved muscle mass).


Eligibility criteria: Inclusion Criteria:

* healthy moderately overweight

Exclusion Criteria:

* Pregnant women
* Inability to complete prescribed supplement regimen
* Current use of incompatible medications or supplements (weight loss, mood support, or blood sugar balance)

Primary outcomes:
measure: Body Weight
timeFrame: 12 weeks
Secondary outcomes:
measure: Microbiome Balance
timeFrame: 12 weeks
measure: Mood State
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Plymouth
country: United States
facility: 3Waves Wellness
state: Massachusetts
Study officials:
References: