louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01111968: Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines
Official title: Evaluation of Safety, Tolerability and Immunogenicity of Adjuvanted Candidate Vaccines Against Pandemic Influenza A (H1N1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: vaccine
pandemic influenza A
adjuvant
safety
Lead sponsor: Butantan Institute
Sponsor class: OTHER_GOV
Collaborators: name: Hospital Universitario da USP
name: University of Sao Paulo
First posted: 2010-04-28
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.

Detailed description: The candidate vaccines are produced by Butantan institute - Sao Paulo, Brazil

Eligibility criteria: Inclusion Criteria:

* Health adults of both genders
* Age ≥ 18 ≤ 50 years
* Able to understand every required study procedure
* Female volunteers should agree to take an acceptable contraceptive method Menopause is characterized by absence of menstrual flux for two consective years
* Normal values for pre-stablished laboratory assays
* Accpetance to participate and sign the consent form

Exclusion Criteria:

* Any chronic condition
* Be on immunossupressive or stimulant therapy
* Have egg alergy
* Have past history of alergy to sazonal influenza vaccine
* Have received another inactivated vaccine within the prior 2 weeks or a live vaccine in the past four weeks to his/her participation in the study
* Acute infectious disease during seven days prior vaccination
* Female on breasthfeeding
* Confirmed prior infection by pandemic influenza A
* Participation in another clinical trial in the last 6 months
* Any other condition identified by the principal investigator which is considered not safe for enrollment of the volunteer

Primary outcomes:
measure: the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay
timeFrame: 21 days after each vaccination
Secondary outcomes:
measure: Safety and tolerability
timeFrame: 30 minutes and 72 hours after vaccination
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clinica do Instituto da Criança do hospital das Clinicas da Faculdade de Medicina da USP
city: Sao Paulo
country: Brazil
facility: Centro de Pesquisa Clínica do Hospital Universitário da USP
Study officials:
affiliation: Children´s Institute - School of Medicine of University of Sao Paulo
name: Lucia MA Campos, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky Mdo C, Cardoso MR, Luna E, Mondini G, Guedes Jda S, Raw I. A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems. Vaccine. 2011 Nov 8;29(48):8974-81. doi: 10.1016/j.vaccine.2011.09.040. Epub 2011 Sep 21.
Clinical trial NCT06789068: Lactose Intolerance in Infants With Gastrointestinal Disturbances
Official title: Lactose Intolerance in Infants With Gastrointestinal Disturbances
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactose Intolerance
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study enrolled thirty infants who presented by GIT symptoms and their CoMiSS was ≥ 12. The patients were assessed upon presentation, after 2 weeks of receiving lactose free diet regimen and 2 weeks after rechallenging them with lactose. Assessments of infants included anthropometric measurements, CoMiSS estimation, Neonatal/Infant Pain Scale (NIPS) and pediatric quality of life assessment (Peds QL). The study aims to detect the frequency of infants with LI with positive Cow's Milk-related Symptom Score (CoMiSS) (which could lead to misdiagnosis as CMPA) and validate of this score to be used as a screening tool for LI in infants.


Eligibility criteria: Inclusion Criteria:

* Artificially fed infants.
* Presented with GIT symptoms such as vomiting, diarrhea, abdominal pain, discomfort and distention.
* Cow's Milk-related Symptom Score (CoMiSS) of 12 or higher.

Exclusion Criteria:

* Infants with positive family history of Cow's milk protein allergy CMPA.
* Any allergic diseases.
* History of anaphylaxis.
* Atopic dermatitis, swelling of lips or eyelids, urticaria or wheezy chest.

Primary outcomes:
measure: Frequency of infants with LI and mis diagnosed as a cow milk protein allergy.
timeFrame: 4 weeks intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
Clinical trial NCT02840968: Adherence to Mediterranean Diet and Phase Angle
Official title: Influence of Mediterranean Diet on Phase Angle in a Sample of Adult Population: Results of a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mediterranean Diet
Phase Angle
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 1464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recruitment strategies included attendance at the outpatient obesity clinics at the investigators Department or the outdoor hospital of the Campus Salute. The study is part of a large database started in 2010 to investigate the health status of the general population of Campania Region as analysed by the free consultation, visit, and diagnostics for people coming to the outdoor hospital held in different public squares of the investigators Region.

Brief summary: In this cross-sectional observational study the investigators evaluated the association between the adherence to the MD and PhA in a sample of adult population, stratified according to categories of sex, age, and BMI.


Eligibility criteria: Inclusion Criteria:

* Caucasian Subjects
* Healthy Subjects (defined as absence of a clinical condition that potentially influences fluid balance, ie, renal, endocrine, or myocardial disease, ascertained by participant questionnaire)

Exclusion Criteria:

* Hypocaloric diet in the last three months or specific nutritional regimens, including vegan or vegetarian diets,
* Vitamin/mineral or antioxidant supplementation,
* Clinical conditions that could influence fluid balance, including liver or renal failure, cancer, and acute or chronic inflammatory diseases, based on a complete medical examination and laboratory investigations,
* Occasional or current of use of drugs that could influence fluid balance, including non-steroidal anti-inflammatory drugs, hormone replacement therapy, diuretics weight-loss medications, anticonvulsivants and psychotropic agents, laxative use,
* Altered thyroid hormone function tests or thyroid hormone treatment,
* Alcohol abuse according to the Diagnostic and Statistical Manual of Mental Disorders (DSM)-V diagnostic criteria,
* Patients with implanted pacemakers or defibrillators because of the theoretical possibility of interference with the device activity due to the field of current induced by the impedance measurements,
* Subjects underweight with BMI\<18.5,
* Subjects dropped out from the study since they refused to participate.

Primary outcomes:
measure: Adherence to Mediterranean Diet by Predimed Questionnaire
timeFrame: January 2010 - May 2016
measure: Phase Angle by Bioimpedance Analysis
timeFrame: January 2010 - May 2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02879968: Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer
Official title: Correlation Between Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: serum squamous cell carcinoma antigen
tumor volume
Head and Neck Cancer
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and Neck squamous cell carcinoma

Brief summary: Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.

Detailed description: The study is a cross-sectional study. A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients.

The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott).

The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.

Correlation between both parameters will be determined.

Eligibility criteria: Inclusion Criteria:

* Histologically proven squamous cell carcinoma in Head and Neck
* Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen

Exclusion Criteria:

* Metastatic disease
* Accompanied Non-Head and Neck squamous cell carcinoma
* Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma
* Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis
* Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst
* Renal failure
* Using antihistamine eye drops

Primary outcomes:
measure: Correlation between serum squamous cell carcinoma antigen and tumor volume
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hadyai
country: Thailand
facility: Faculty of Medicine, Prince of Songkla University
state: Songkhla
Study officials:
References:
Clinical trial NCT02881268: Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit
Official title: Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Hospitalized in Intensive Care Unit
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient hospitalized in intensive care unit with or without sepsis

Brief summary: Open-label, non-randomized, prospective, single center, observational, translational study

Detailed description: The aim of this trial is to study immunosuppression biomarkers in patients hospitalized in intensive care unit in comparison to non-septic patients.

Prevalence of immunosuppression acquired in intensive care unit will be studied and patients most likely to develop nosocomial infection will be early identified

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient hospitalized in intensive care unit for any reason
* Patient with infection started less than 5 days before admission
* Patient with mechanical ventilation or not
* Patient with arterial catheter for an invasive monitoring of blood pressure
* Patient informed about the study protocol and approved to participate.
* Patients hospitalized for a severe bacterial infection (severe sepsis or septic shock)
* Patient hospitalized for a non-infectious disease

Exclusion Criteria:

* Pregnancy
* Advanced immunosuppression defined by proved humoral or cellular impairment by continuous administration of steroids at any dose since more than one month before hospitalization, transplantation, radiotherapy or chemotherapy in the preceding year
* Initiation of an immunosuppressive therapy as chemotherapy, cyclophosphamide or high dose corticotherapy (\>0.5mg/kg/day)

Primary outcomes:
measure: Detection of immunosuppression biomarkers in septic and non-septic patients hospitalized in intensive care unit
timeFrame: Day 14
Secondary outcomes:
measure: Association of immunosuppression biomarkers with occurrence of events reflecting a clinical immunosuppression
timeFrame: Day 14
measure: Association of immunosuppression biomarkers with patients demographic data
timeFrame: Day 14
measure: Association of immunosuppression biomarkers with patients clinical data
timeFrame: Day 14
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT05708768: Digital, Innovative, Sustainable, and Knowledge-based Acute Municipal Healthcare Services Illness and Trauma
Official title: Developing and Implementing Digital, Innovative, Sustainable, and Knowledge-based Municipal Healthcare Services in Acute Illness and Trauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Chronic Conditions
Acute Disease
Lead sponsor: Ostfold University College
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Ostfold Hospital Trust
name: OsloMet
First posted: 2023-02-01
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients recieving services from the physician manned rapid response car will be included.

Brief summary: Through introducing physicians in front in the medical assessment and decision-making processes in acute and sub-acute illness in the municipalities, as well as including machine learning in analyzing prospective and retrospective data, the project will develop and implement innovative and knowledge-based digital diagnostic tools and decision-making support systems to be used in the municipalities. As such, the project will contribute to early identification of severe illness, prevent deterioration of disease, and facilitate early medical intervention.

Detailed description: The overall objective of the project is to determine if and how innovative digital decision-making tools based on artificial intelligence (AI) can help to develop more accessible, efficient, cost-effective, and sustainable municipal healthcare services. More specifically, the project aims are:

* to explore different outcomes of a municipal rapid response car manned with dedicated physicians
* to compare outcomes from Norwegian and Swedish out-of-hospital EMS in acute illness
* to explore how decision-making tools based on AI can be used to optimize dispatch
* to explore how decision-making tools based on AI can assist dispatched personnel and in prehospital care
* to determine the quality and efficacy of the different systems explored through cost-analyses and exploration of stakeholders' experiences with the decision-making tools

Eligibility criteria: Inclusion Criteria:all patients receiving services from the physician manned rapid response car -

Exclusion Criteria:none

-

Primary outcomes:
measure: At location
timeFrame: 2 hours
Secondary outcomes:
measure: Transported
timeFrame: 2 hours
Other outcomes:
measure: Institutionalized
timeFrame: 12 hours
Locations:
city: Fredrikstad
country: Norway
facility: Fredrikstad Casualty
state: Viken
Study officials:
affiliation: Østfold University College
name: Randi M Sommerfelt, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05018468: Quality of Ventilation With Facial Versus Nasal Mask vs Nasal Mask Anesthesia in Children 3 to 12 Years Old
Official title: Evaluation of the Quality of Ventilation With Facial Versus Nasal Mask After Induction of Anesthesia in Children 3 to 12 Years Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilation
Intubation Complication
Intubation; Difficult or Failed
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 70
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this single-blind clinical trial study, 70children who are candidates for lower abdominal elective surgery under general anesthesia presented at Imam Hossein Hospital in Isfahan will be included in the study and will be divided into 2 groups. In the first group, ventilation with facial mask and in the second group, ventilation with nasal mask will be done for three minutes. Then the reduction in SPO2 and the impossibility of ventilation of patients will be evaluated and compared between the two groups.


Eligibility criteria: Inclusion Criteria:

* Age category between 3 to 12 years
* Candidate for lower abdominal elective surgery under general anesthesia
* No obstruction in the nasal pathway
* No deformity and fractures in facial
* No acute or chronic lung disease

Exclusion Criteria:

* Impossibility of airway oropharyngeal ventilation
* Impossibility of ventilation of the anatomical facial mask with neck extension
* Dissatisfaction with participating in the study.

Primary outcomes:
measure: Average airway pressure
timeFrame: change from baseline at five minutes after incubation
measure: Average End-tidal CO2 (EtCO2)
timeFrame: change from baseline at five minutes after incubation
measure: Average Oxygen saturation (SpO2)
timeFrame: change from baseline at five minutes after incubation
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra Hospital
Study officials:
References:
Clinical trial NCT01204268: The Neuroprotection of Sevoflurane Preconditioning on Intracranial Aneurysm Surgery
Official title: The Neuroprotection of Sevoflurane Preconditioning on Perioperative Ischemia-reperfusion Injury During Intracranial Aneurysm Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Ischemia
Keywords: cerebral ischemia
sevoflurane preconditioning
intracranial aneurysm surgery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery.

Detailed description: The current study is designed to clarify the neuroprotective effect of sevoflurane preconditioning on the patients underwent intracranial aneurysm surgery. The patients with cerebral aneurysm will be recruited in current study. The sevoflurane preconditioning will be performed before the surgical procedure. The neurological injury biomarkers, such as S-100b and NSE will be detected. The neurological function and recovery will be assessed after the surgery.

Eligibility criteria: Inclusion Criteria:

* Patient under intracranial aneurysm surgery.

Exclusion Criteria:

* Patients who refused to participate or who had a history of chemotherapy/convulsions two weeks prior to admission, stroke/cardiopulmonary resuscitation/head trauma three months prior to admission, Alzheimer's disease, amyotrophic lateral sclerosis, and prior melanoma were excluded.

Primary outcomes:
measure: S-100B,NSE
timeFrame: 7 days
Secondary outcomes:
measure: Karnofsky Performance Scale,NIH stroke index, MMSE
timeFrame: 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Hailong Dong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03731468: Ultrasound Guided Intermediate Cervical Plexus Block in Thyroid Surgery
Official title: Effect of Dexmethasone Addition to Bupivacaine in Bilateral Intermediate Cervical Block in Thyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: studying the effect of dexmeditomidine addition to bupivacaine in bilateral intermediate cervical block for patients undergoing thyroidectomy under general anaesthesia

Detailed description: 80 patients who will be undergoing elective thyroidectomy will be randomly allocated into one of two groups ; group A will receive 20 mg isobaric bupivacaine + 8 mg dexamethasone(diluted in 5 ml) group B will receive 20 mg isobaric bupivacaine + 1 ml normal saline. block will be done under complete a septic condition after induction of general anaesthesia.

Eligibility criteria: Inclusion Criteria:

* Elective surgery
* ASA 1, II, AND III

Exclusion Criteria:

* Patient refusal
* Infection at the entry site
* BMI \> 3

Primary outcomes:
measure: postoperative analgesia duration
timeFrame: 24 hour postoperative
Secondary outcomes:
measure: postoperative complications related to the block
timeFrame: 8 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References:
Clinical trial NCT05447468: Influence of Proximal Motor Control in Treating Lateral Epicondylitis
Official title: Influence of Proximal Motor Control in Treating Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Epicondylitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of scapular muscles (lower trapezius, middle trapezius and serratus anterior) strengthening on pain, pain free hand grip strength and functional outcome added to conventional physical therapy in patients with chronic Lateral Epicondylitis.

Detailed description: This study will try to investigate if scapular muscles strengthening have an effective role on pain, pain free hand grip strength and function when added to conventional physical therapy in patients with LE.

Eligibility criteria: Inclusion Criteria:

1. Symptoms of lateral epicondylitis from at least the past 3 months.
2. Pain in at least two of the following four tests; Tomsen test, Maudsley test, Mill's test and handgrip dynamometer test.
3. Their ages range from 30-50 years old.

Exclusion Criteria:

Subjects will be excluded from the study if they have:

1. Peripheral neuropathy.
2. Lesions of upper limb nerves.
3. History of surgery in the affected elbow 6 months ago.
4. Cervical radiculopathy.

Primary outcomes:
measure: Assessment of change in pain intensity
timeFrame: at baseline and after 6 weeks of intervention
measure: Assessment of change in hand grip strength
timeFrame: at baseline and after 6 weeks of intervention
measure: Assessment of change in function
timeFrame: at baseline and after 6 weeks of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Outpatient clinic, Faculty of Physical Therapy, Cairo university
Study officials:
affiliation: shereenm34@gmail.com
name: Shereen Mohamed, physiotherapist
role: PRINCIPAL_INVESTIGATOR
References: