louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02690532: Gut Permeability Assessment in Celiac and Gluten Sensitive Children
Official title: The Role of Gut Permeability in Developing Celiac Disease and Non-Celiac Gluten Sensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: Celiac
Gluten
Sensitivity
Permeability
Non-celiac gluten intolerance
Gastrointestinal Diseases
Digestive System Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of three groups of children, aged 2-17 years. The first group will be children with siblings that have celiac disease, the second group will be children with non-celiac gluten sensitivity and the third group will be healthy children.

Brief summary: This study will assess the effect of gluten on gut barrier function. Investigators at the Mayo Clinic have developed a new gut permeability test using rhamnose (sugar \& water solution), and are hoping to prove its effectiveness in a clinical setting.

Detailed description: The aim of this study is to assess effect of gluten on the gut barrier function in patients at high risk for celiac disease and non-celiac gluten sensitivity (NCGS) patients. This study will assess the gut permeability in three groups of patients 1) children who are at high risk for developing celiac disease (CD) (siblings of patients with celiac disease), 2) Children who are self-diagnosed with NCGS and 3) control group of patients matched for age and gender. Patients will undergo celiac serologic and genetic testing, after which the rhamnose test will be performed to assess the presence of increased gut permeability.

Eligibility criteria: High Risk group:

* Sibling with a confirmed diagnosis of celiac disease
* No history Celiac disease or any other bowel disease

Non-Celiac Gluten Sensitivity group:

* Self-diagnosis of gluten sensitivity
* No history of celiac disease or other bowel disease

Healthy group:

* Absence of celiac disease or any other bowel disease
* No sensitivity to gluten

Primary outcomes:
measure: Gut Permeability
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Imad Absah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03462732: Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery
Official title: Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery , Prospective Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complication
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: assignment
Primary purpose: PREVENTION

Brief summary: The value of this study is to compare between stented endotracheal tube with nelaton catheter and non stented tube as regard nasotracheal related complications as epistaxis and nasal cavity injury.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients scheduled for dental surgery under general anesthesia age 3-9 years
* physical status American society of Anesthesiologist(ASA) I orII

Exclusion Criteria:

* History of recurrent epistaxis
* Coagulopathy
* Previous nasal surgery
* History of nasal trauma
* Severe renal , hepatic or cardiovascular disease
* History of drug allergy to the drugs used in the study

Primary outcomes:
measure: incidence and severity of Epistaxis
timeFrame: immediately after nasotracheal intubation
Secondary outcomes:
measure: Histopathology of the endotracheal tube contents after extubation
timeFrame: immediately after extubation
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University hospitals
Study officials:
References:
Clinical trial NCT01212432: Daptomycin Pharmacokinetics in Critically Ill Patients Undergoing Continuous Veno-venous Hemodiafiltration, a Dose Finding Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gram-Positive Bacterial Infections
Keywords: Gram positive infection and CRRT
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Daptomycin kinetics in CRRT

* Trial with medicinal product


Eligibility criteria: Inclusion criteria:

* male or female of 18 years or older
* females: negative pregnancy test
* Hospitalisation in the medical ICU
* High suspicion or evidence of Gram-positive infections requiring antibiotic therapy
* Subjects receiving standard antibiotic treatment for Gram-positive infection
* Evidence of renal failure
* Clinical necessity for continuous renal replacement therapy
* Written informed consent signed by the patient or a next of kin and an independent physician in case the patient is not able to sign.

Exclusion criteria:

* Skeletal muscle disorders or CPK levels of \> 2 x ULN
* History of hypersensitivity to the drug
* Participation in another study
* Subjects with a history of muscle disease
* Patients with severe liver function impairment (Child
* Life expectancy of less than 5 days

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT03256032: Prevalence and Factors Associated With Postoperative Hypothermia in Mulago Hospital
Official title: Prevalence and Factors Associated With Postoperative Hypothermia Among Patients Undergoing Anaesthesia and Surgery in Mulago National Referral Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Operative Hypothermia
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2017-08-21
Enrollment: 770
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing surgery and anaesthesia at Mulago National Referral Hospital who meet the eligibility criteria.

Brief summary: Patient's sublingual temperature was measured postoperatively on entry to the recovery room.

Detailed description: Adult patients who underwent non-neurological and non-cardiac surgery had their sublingual temperature measured postoperatively on entry to the recovery room.

Eligibility criteria: Inclusion Criteria:

* All patients of 18 years and above, undergoing surgery and anaesthesia lasting longer than 30minutes.
* All patients of 18 years and above, undergoing elective and emergency non cardiac and non-neurological operations in Mulago National Referral Hospital.

Exclusion Criteria:

* Patients with contraindications to measurement of sublingual temperature

Primary outcomes:
measure: Postoperative hypothermia
timeFrame: July 2016 to February 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MakCHS
name: Arthur Emoru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01216332: Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Official title: Randomized, Double Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High Dose Trivalent Inactivated Influenza Vaccine in Pediatric Patients With Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediatric Patients With Acute Lymphoblastic Leukemia
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with Acute Lymphoblastic Leukemia.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients with standard or high risk Acute Lymphoblastic Leukemia.
* Must be in 1st complete remission.
* Must be 4 weeks into maintenance therapy.
* 17 years of age, inclusive.
* Available for duration of study.

Exclusion Criteria:

* History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein.
* History of Guillain-Barre syndrome.
* Evidence of relapsed disease.
* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol.
* Have any condition that the investigator believes may interfere with successful completion of the study.
* History of receiving 2010 - 2011 influenza vaccine.
* Pregnant female.
* History of proven influenza disease after September 1, 2010.

Primary outcomes:
measure: Local Reactions After Each Vaccination
timeFrame: From baseline to 7 days after each vaccination
measure: Systemic Reaction
timeFrame: From baseline to 7 days after each vaccination
Secondary outcomes:
measure: Immunogenicity: Number of Participants With a Post-titer Greater Than or Equal to a Fourfold Titer Rise
timeFrame: About 6 months after last dose of vaccine.
measure: Immunogenicity:Number of Participants With a Pre-titer ≥1:40
timeFrame: About 6 months after last dose of vaccine.
measure: Immunogenicity: Number of Participants With a Post-titer ≥1:40
timeFrame: About 6 months after last dose of vaccine.
measure: Immunogenicity: The Geometric Mean Titers Pre-vaccine in Study Participants
timeFrame: baseline
measure: Immunogenicity: Geometric Mean Titers Post-vaccine in Study Participants
timeFrame: About 6 months after last dose of vaccine.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
Study officials:
affiliation: Vanderbilt Universtiy Medical Center
name: Natasha Halasa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04267432: The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
Official title: The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-02-12
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis

Detailed description: This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.

Eligibility criteria: Inclusion criteria

1. Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)
2. Without heart, liver, kidney, endocrine and other major organic diseases (patient return)

Exclusion criteria

1. With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return)
2. People with mental illness

Primary outcomes:
measure: KL Grade (evaluated by doctor)
timeFrame: Change from baseline at 6 months
measure: WOMAC™ Osteoarthritis Index
timeFrame: Change from baseline at 6 months
Secondary outcomes:
measure: Blood C-terminal telopeptide of collagen type II (CTX-II) level
timeFrame: Change from baseline at 6 months
measure: Blood C-reactive protein (CRP) level
timeFrame: Change from baseline at 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ting-Ming Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01374932: CPASMA: Is There an Improvement in Asthma in Patients With Both Asthma and OSAS Treated With CPAP?
Official title: The CPASMA Trial: Is There an Improvement in Asthma in Patients With Both Asthma and Obstructive Sleep Apnoea Syndrome (OSAS) Treated With Continuous Positive Airway Pressure (CPAP) After Six Months?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma
Obstructive Sleep Apnea Syndrome
Keywords: Asthma
Obstructive Sleep Apnea Syndrome
Lead sponsor: Cimera
Sponsor class: NETWORK
First posted: 2011-06-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The CPASMA trial is a descriptive, prospective, multicentre clinical trial, with a before/after Continuous Positive Airway Pressure (CPAP) assessment in participating patients. It aims to answer the following question: Is there an improvement in asthma in those patients with both asthma and obstructive sleep apnoea syndrome (OSAS) treated with CPAP after six months?. It is hypothesized that treatment of OSAS with CPAP in patients with both OSAS and asthma concommitantly, may have a beneficial effect also on asthma outcomes. This clinical effect in asthma could be assessed objectively by applying validated questionnaires for quality of life and asthma control.

Detailed description: Full protocol in Spanish, available upon request

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 to 70 yrs.) with asthma who require treatment with CPAP because of OSAS (RDI\> = 20 events per hour)

Exclusion Criteria:

* unstable or severe comorbidity,
* patients in treatment with drugs that interfere with the clinical course of asthma and/or OSAS,
* cognitive/psychiatric disorders that preclude patient participation/cooperation,
* COPD or other lung disease accompanied by chronic airflow limitation, and
* any clinical condition considered severe enough by the investigators to preclude all the diagnostic and therapeutic procedures outlined in this protocol.

Primary outcomes:
measure: Asthma control questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Inca
country: Spain
facility: Hospital comarcal de Inca
state: Balearic Islands
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Príncipe de Asturias
state: Madrid
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i de Sant Pau
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cantabria.
country: Spain
facility: Hospital de Laredo
city: Cádiz.
country: Spain
facility: Hospital de Jerez
city: Las Palmas
country: Spain
facility: Hospital Universitario Dr. Negrín
city: Madrid
country: Spain
facility: Hospital Moncloa
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Sabadell.
country: Spain
facility: Corporació Sanitària Parc Taulí
Study officials:
affiliation: Hospital de Inca
name: Jose Serrano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567632: Generation of Standard Laboratory Values for Pneumococci Antibodies
Official title: Generation of Standard Laboratory Values for Pneumococci Antibodies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Reference Values
Keywords: Pneumococci
Antibody
Standard laboratory values
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2007-12-05
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any clinically and immunologically healthy subject of any age undergoing selective surgery

Brief summary: The determination of reference values is a necessary basis for research and clinical routine testing for pneumococci antibodies

Detailed description: This study is meant to determine specific pneumococcal antibodies stratified for age. The investigators also correlate our assay with the results from a commercially available pneumococcal screening ELISA (iGG1 and IgG2) in order to facilitate a screening for immunodeficiency, and to monitor the success of a performed immunization

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing elective surgery

Exclusion Criteria:

* Chronic illness condition,
* Immunodeficiency

Primary outcomes:
measure: sufficient samples to calculate reference values
timeFrame: 10(2006-10/2007)
Secondary outcomes:
measure: sufficient samples to correlate with screening assay
timeFrame: 10/2006-10/2007
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University, Department of Pulmonology
state: Hessen
Study officials:
affiliation: Goethe University, childrens Hospital
name: Markus A Rose, M.D., Ph.D., M.P.H
role: STUDY_CHAIR
References:
Clinical trial NCT01943032: Discordant Hormonal Status of Breast Cancer.
Official title: Discordant Hormonal Status Between Primary Tumor and Axillary Lymph Node in Breast Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Neoplasm of Breast.
Lead sponsor: National Cancer Institute, Thailand
Sponsor class: OTHER_GOV
First posted: 2013-09-16
Enrollment: 105
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer Patients Stage I,II and III.

Brief summary: The purpose of this study is to determine discordant hormonal status of primary breast tumor and metastatic breast cancer cells at regional lymph nodes in node positive breast cancer patients.

Detailed description: Hormonal status between primary breast tumor and axillary lymph node were analyzed.

Eligibility criteria: Inclusion Criteria:

* Breast cancer patients stage I,II and III with axillary lymph nodes metastasis.

Exclusion Criteria:

* Breast cancer patients stage I,II and III without axillary lymph nodes metastasis.

Primary outcomes:
measure: Association of hormonal status between primary breast tumor and axillary lymph nodes
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: National Cancer Institute, Thailand.
state: Bangkok
Study officials:
affiliation: National Cancer Institute, Thailand
name: AKANIST PIYAPANT, MD.,FRCST.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cristofanilli M, Budd GT, Ellis MJ, Stopeck A, Matera J, Miller MC, Reuben JM, Doyle GV, Allard WJ, Terstappen LW, Hayes DF. Circulating tumor cells, disease progression, and survival in metastatic breast cancer. N Engl J Med. 2004 Aug 19;351(8):781-91. doi: 10.1056/NEJMoa040766.
citation: Cristofanilli M. The biological information obtainable from circulating tumor cells. Breast. 2009 Oct;18 Suppl 3:S38-40. doi: 10.1016/S0960-9776(09)70270-X.
Clinical trial NCT01023932: Auditory Neuropathy and Cochlear Implants
Official title: Cochlear Implants in Children With Auditory Neuropathy/ Auditory Dys-Synchrony
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cochlear Implants
Auditory Neuropathy
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2009-12-02
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with auditory neuropathy who had received a cochlear implant

Brief summary: The electrical stimulation generated by the Cochlear Implant (CI) may improve the neural synchrony and hence contribute to the development of auditory skills in patients with Auditory Neuropathy / Auditory Dys-synchrony (AN/AD). Goal: The goal of the research was to evaluate the auditory performance and the characteristics of the electrically evoked compound action potential (ECAP) in a group of 18 cochlear implants recipients with AN/AD.The auditory perception was evaluated by sound field thresholds and speech perception tests. To evaluate ECAP's characteristics, the threshold and amplitude of neural response together with the amplitude growth and recovery functions were evaluated at 80Hz stimulation rate.The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research. The auditory perception benefits as well as the possibility to measure the ECAP showed that the electrical stimulation could compensate the neural dys-synchrony caused by the AN/AD. However, a unique clinical procedure cannot be proposed at this point. Therefore, a careful and complete evaluation of each AN/AD patient before recommending the Cochlear Implant is advised


Eligibility criteria: Inclusion Criteria:

* All children with AN/AD who had received the cochlear implant during the research´s period.

Primary outcomes:
measure: The CI was seen as an efficient resource to develop auditory skills in 94% of the AN/AD patients considered by the research.
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Bionic Ear Center
state: SP
Study officials:
References:
citation: de Carvalho ACM, Bevilacqua MC, Sameshima K, Filho OAC. Auditory neuropathy/Auditory dyssynchrony in children with Cochlear Implants. Braz J Otorhinolaryngol. 2011 Jul-Aug;77(4):481-487. doi: 10.1590/S1808-86942011000400012.