louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00389558: Antiseptic Use and Dressing Application
Official title: Comparison of Amukin Versus Biseptine Use for Dressing Application of Epicutaneocavous Catheters for Nosocomial Infection Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Colonization
Catheterization
Bacterial Infection
Keywords: Skin colonization
Antiseptic
Epicutaneocavous catheter dressing
Infant
Lead sponsor: Maternite Regionale Universitaire
Sponsor class: OTHER
First posted: 2006-10-19
Enrollment: 453
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of the study are:

1. To compare the local efficacy (skin colonization) of 2 commercialized antiseptics used for the disinfection of the dressing application for an epicutaneocavous catheter (EPI).
2. To evaluate whether the bacteria responsible for nosocomial infection is comparable to the flora diagnosed at the EPI site.

Detailed description: Epicutaneocavous catheter is a significant risk factor for nosocomial infection in newborn infants. These infections have been related to local bacterial colonisation. Therefore thorough disinfection should lower the risk of nosocomial infection. However, the local efficacy of antiseptic use has not yet been clearly evaluated in this situation.

Eligibility criteria: Inclusion Criteria:

* All infants admitted to the Neonatal Intensive Care Unit
* Epicutaneocavous catheter insertion indication

Exclusion Criteria:

* Epicutaneocavous catheter not inserted within the Unit

Primary outcomes:
measure: Efficacy on skin colonization of two commercially available antiseptics
timeFrame: 2 weeks
Secondary outcomes:
measure: In case of nosocomial infection, relationship with skin bacteria
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Nancy
country: France
facility: Maternite Regionale Universitaire
Study officials:
affiliation: University of NANCY, France
name: Jean-Michel HASCOET, MD
role: STUDY_DIRECTOR
affiliation: Maternite Regionale Universitaire
name: Monique LUX, Pharmacist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mahieu LM, De Dooy JJ, De Muynck AO, Van Melckebeke G, Ieven MM, Van Reempts PJ. Microbiology and risk factors for catheter exit-site and -hub colonization in neonatal intensive care unit patients. Infect Control Hosp Epidemiol. 2001 Jun;22(6):357-62. doi: 10.1086/501913.
Clinical trial NCT02326558: Comparison of Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
Official title: Comparison of Zero Ischemia Laparoscopic Microwave Ablation-Assisted Enucleation and Conventional Laparoscopic Partial Nephrectomy in the Treatment of T1a Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma
Keywords: zero ischemia
microwave
ablation
enucleation
renal cell carcinoma
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2014-12-29
Enrollment: 183
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the feasibility, safety and efficiency of zero ischemia laparoscopic microwave ablation-assisted enucleation in comparison with conventional laparoscopic partial nephrectomy in the treatment of T1a renal cell carcinoma.

Detailed description: Microwave ablation has been widely used in the minimally-invasive treatment of renal tumors. Recently, a technique of laparoscopic microwave ablation-assisted renal tumor enucleation was developed, but the experience was preliminary. This study aims to evaluate the feasibility, safety and efficiency of this technique, particularly its role in the preservation of renal function, in comparison with conventional laparoscopic partial nephrectomy.

Eligibility criteria: Inclusion Criteria:

* patients with sporadic, unilateral, newly diagnosed T1a presumed renal cell carcinoma
* exophytic cancer
* distance from the hilar renal vessels and urinary collecting system \>= 1cm
* patients with normal contralateral renal function (differential renal function of \>40% as determined by renal scintigraphy)
* patients giving consent to the participation in the current clinical trial

Exclusion Criteria:

* patients with a history of other renal diseases, such as urinary lithiasis
* patients with a history of renal surgery

Primary outcomes:
measure: absolute change in glomerular filtration rate (GFR) of the affected kidney
timeFrame: baseline, 3 months and 12 months
Secondary outcomes:
measure: absolute change in eGFR of the affected kidney
timeFrame: baseline, 3 months, 6 months and 12 months
measure: absolute change in total GFR
timeFrame: baseline and 6 months
measure: blood loss
timeFrame: during surgery
measure: operation time
timeFrame: during surgery
measure: surgical margin
timeFrame: 1 month
measure: postoperative complications
timeFrame: up to 6 months
measure: progression-free survival
timeFrame: 12 months
measure: local recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Yi-Ran Huang, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT02600663: Identification of Patients at Risk of Chronic Back Pain Using Questionnaires
Official title: Identification of Patients at Risk of Chronic Back Pain Using Questionnaires
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Back Pain
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2015-11-09
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with acute back pain presenting at the general pratcioner

Brief summary: Patients with acute back pain (\<6 weeks) presenting at their general practitioner will be enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening Tool. These two questionnaires categorize back pain patients into individuals at risk of chronic back pain and those not at risk. Furthermore, data concerning pain location, severity, duration and impairment will be collected. Study participants will receive standard care treatment prescribed by their general practitioner. Six months later, study participants will receive a questionnaire in order to collect data concerning their present pain situation. Patients with relevant impairment in their activities of daily living as a result of back pain will be categorized as individuals with chronic back pain. Categorization at six months will be compared with the categorization at presentation.


Eligibility criteria: Inclusion Criteria:

* acute (\<6 weeks) back pain
* \>20 und \<60 years of age
* good oral and written knowledge of German language

Exclusion Criteria:

* any treatment for back pain within the last 6 months
* Cauda equina
* tumor
* generalized pain
* severe systemic illness
* substance abuse
* pregnancy

Primary outcomes:
measure: risk of chronic back pain determined by Heidelberger short questionnaire score
timeFrame: at enrolment
measure: risk of chronic back pain determined by Keele questionnaire
timeFrame: at enrolment
Secondary outcomes:
measure: numeric rating scale average pain intensity
timeFrame: at enrolment, at 6 months
measure: numeric rating scale minimal pain intensity
timeFrame: at enrolment, at 6 months
measure: numeric rating scale pain related sleep-loss
timeFrame: at enrolment, at 6 months
measure: clothepin-algometry (numeric rating scale)
timeFrame: at enrolment
measure: working days missed
timeFrame: at enrolment, at 6 months
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References:
Clinical trial NCT05965063: The Role of Bifidobacterium Intervention in Food Allergic Infants
Official title: Evaluation of the Influence of Bifidobacterium on the Infants With Food Allergic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy in Infants
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 180
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infant food protein allergy is the most common allergic disease in children, which can lead to infantile-specific dermatitis, intestinal inflammation, and so on. Dietary avoidance is a common strategy for food protein allergy in infants and young children. However, the hidden etiology of food protein allergy or multiple food allergies often leads to poor efficacy. The aim of this study is to observe the clinical effectiveness of Bifidobacterium intervention on food allergy.


Eligibility criteria: Inclusion Criteria:

* 0 -12 months infant
* Infants that are allergic (confirmed by an allergist) to at least one of the main food allergens (cow's milk, egg, soy or wheat) and is following an elimination diet to at least one of these allergens.

Exclusion Criteria:

* Patients had used probiotics within 1 month prior to the study
* Allergy or intolerance to probiotics or their excipient
* Serious primary diseases of the cardiovascular, nervous, respiratory,hepatobiliary immunology，and endocrine systems;

Primary outcomes:
measure: The milk related symptom score at the 4th week
timeFrame: Treatment for 4-week
Secondary outcomes:
measure: The milk related symptom score at the 8th week
timeFrame: Treatment for 8-week
measure: The milk related symptom score at 12th week
timeFrame: Treatment for 12-week
Other outcomes:
measure: The percentile number of height at the 4th, 8th and12th week
timeFrame: Treatment for 4-week, 8-week and 12-week
measure: The percentile number of weight at the 4th, 8th and 12th week
timeFrame: Treatment for 4-week, 8-week and 12-week
measure: The percentile number of head circumference at the 4th, 8th and 12th week
timeFrame: Treatment for 4-week, 8-week and 12-week
measure: The composition of intestinal microbiome
timeFrame: Treatment for 4-week, 8-week and 12-week
measure: The composition of intestinal microbiome metabolites
timeFrame: Treatment for 4-week, 8-week and 12-week
measure: the messenger ribonucleic acid (mRNA) expression of blood
timeFrame: Treatment for 12-week
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: CHUNDI Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04603963: Inspiratory Muscle Training in Patients With COVID-19
Official title: Efects of Inspiratory Muscle Training in Patients With COVID-19 After Acute Phase. Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid19
Respiratory Disease
Keywords: physiotherapy
exercises
respiratory muscle training
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Only patients with respiratory muscle weakness that were considered as the maximum inspiratory pressure value (less than or equal to 60% of the predicted value) entered for randomization. Stratified randomization was performed in which the impaired chest tomography (absent, less than 50% or greater than 50%) was taken into account to be randomly allocated to the groups.
Primary purpose: TREATMENT

Brief summary: COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. Objective: Improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. Method: Prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. Results: The findings will be compared before and after the approach and will be presented in graphs and tables. Statistical tests will be used considering a significance level of 5%.

Detailed description: Prospective clinical study in patients with COVID-19 admitted to a non-critical unit of a tertiary hospital. They were randomized into a group that received motor and respiratory exercises and another group that received the same exercises associated with respiratory muscle training.

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with COVID-19 through PCR aged over 18 years admitted to non-critical units.

Exclusion Criteria:

* patients with changes in the level of consciousness and non-transient understanding, exclusive palliative care without prognosis.

Primary outcomes:
measure: impact on functionality
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Municipal Hospital Vila Santa Catarina
Study officials:
References:
Clinical trial NCT00869063: Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or Contusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Pain
Keywords: wrist
sprain
strain
contusion
diclofenac
patch
acute pain
acute pain due to mild to moderate wrist sprain, strain or contusion
Lead sponsor: Cerimon Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2009-03-25
Enrollment: 214
Sex: ALL
Minimum age (years): 17
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate wrist sprain, strain or contusion when applied to the painful area.

Detailed description: This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion.

Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will also be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.

Eligibility criteria: Inclusion Criteria:

* Male and female subjects 17 - 75 years of age
* Sustained recent, painful unilateral mild to moderate wrist sprain, strain or contusion
* Meet baseline pain criterion

Exclusion Criteria:

* Open wound or infection at the site of injury
* Severe wrist injury or wrist fracture
* Presence or history of hand, wrist or forearm nerve impingement or palsies
* Use of NSAIDs or opioids within 12 - 24 hours of wrist injury
* Presence or history of peptic ulcers or GI bleeding
* History of intolerance to NSAIDs, acetaminophen, adhesives
* Positive pregnancy test
* Positive drug screen

Primary outcomes:
measure: Change in average pain during daily activity
timeFrame: Day 3
Secondary outcomes:
measure: Change in average pain during daily activity
timeFrame: Day 7
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
References:
Clinical trial NCT03357263: A Study to Evaluate the Safety and Efficacy(Immunogenicity) of GC3114 in Healthy Adults
Official title: Randomized, Single-Blind, Active Comparator-controlled Study to Evaluate the Safety and Immunological Efficacy of GC3114 in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza, Human
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2017-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj..

Detailed description: Healthy adults will be once administered GC3114A(High-dose Quadrivalent influenza vaccine) or GCFLU Quadrivalent Pre-filled syringe inj.. Safety and immunological efficacy will be evaluated.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 19-64 years old
* Informed consent form has been signed and dated
* Able to comply with the requirements of the study

Exclusion Criteria:

* Known systemic hypersensitive to eggs, chicken proteins, or any of the vaccine components
* Personal history of Guillain-Barre syndrome(GBS)
* Subjects with severe chronic disease who are considered by investigator to be ineligible for the study
* Subjects who received a vaccination within 28 days before enrollment or who are scheduled for another vaccination during the study
* Immunocompromised subjects with immunodeficiency disease or subjects receiving immunosuppressive or immunomodulating therapy
* Pregnant or lactating women

Primary outcomes:
measure: Adverse Event
timeFrame: for 7 days from Day0/during study period
Secondary outcomes:
measure: Percentage of participants achieving pre-defined Seroconversion Before and following vaccination
timeFrame: Day 0 and Day 21
measure: Percentage of participants achieving pre-defined Seroprotection Before and following vaccination
timeFrame: Day 0 and Day 21
measure: Geometric Mean Titer and Geometric Mean Titer Ratios of Antibodies to the Investigational Product Before and Following vaccination
timeFrame: Day 0 and Day 21
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Woo Joo KIm, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noh JY, Jang YS, Lee SN, Choi MJ, Yoon JG, Yu DH, Song JY, Cheong HJ, Kim WJ. Randomized, single-blind, active-controlled phase I clinical trial to evaluate the immunogenicity and safety of GC3114 (high-dose, quadrivalent influenza vaccine) in healthy adults. Vaccine. 2019 Aug 23;37(36):5171-5176. doi: 10.1016/j.vaccine.2019.07.076. Epub 2019 Jul 31.
Clinical trial NCT01030263: A Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies
Official title: A Prospective Randomized Trial Comparing Yield of Confocal Endomicroscopy Guided Biopsies With Random Biopsies in the Detection of Specialized Columnar Epithelium in Barrett's Esophagus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Barrett's Esophagus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-12-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: We wish to determine whether biopsies obtained with the technique of fluorescence-aided confocal endomicroscopy will detect more patients with specialized columnar epithelium than random biopsies among patients with Barrett's esophagus who are being monitored with endoscopy.


Eligibility criteria: Inclusion Criteria:

* Age at least 18.
* Barrett's esophagus
* Acid suppressive therapy
* Endoscopic surveillance

Exclusion Criteria:

* Pregnancy or lactation
* Allergy to fluorescein
* Endoscopic esophagitis Los Angeles classification A to D
* Mucosal irregularity or nodules suspicious for dysplastic or cancerous lesion
* Obvious mass lesions or cancer

Primary outcomes:
measure: Whether specialized columnar epithelium was detected.
timeFrame: At biopsy on Day 0.
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Ananya Das, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852863: Identification of Changes in Gastric Volume and Content by Ultrasound Before and After Chewing Gum
Official title: Ultrasound Assessment of Changes in Gastric Volume and Content Before and After Chewing Gum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Volume
Lead sponsor: Fundación Santa Fe de Bogota
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To identify by ultrasound the possible changes in gastric volume and content after chewing gum for an hour in volunteers with complete fasting (more than 8 hours).


Eligibility criteria: Inclusion Criteria:

* adults older or equal than 18 years old
* Minimum of 8 hours of fasting
* must work/study at Fundacion Santa Fe

Exclusion Criteria:

* Comorbidities such as obesity, renal failure, diabetes
* Gastrointestinal Disease

Primary outcomes:
measure: Gastric volume change in mL
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Hospital Universitario Fundacion SantaFe de Bogota
Study officials:
References: