louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02561390: Comparison Between spIgE and Skin Prick Test of Local and Imported Aeroallergens
Official title: In-vivo Potency Evaluation of American Cockroach, Dog, Cat, Dust Mites and Mold Allergen Extracts Produced by Siriraj Hospital Comparing With Imported Extracts by Using Skin Prick Test.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immediate Hypersensitivity
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-09-28
Enrollment: 84
Sex: ALL
Minimum age (years): 10
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The prevalence of Allergic rhinitis(AR) and asthma was increased world wide. In 1998, ISAAC found that prevalence of AR and asthma inThailand was in moderately high group.

Tests for immediated reaction SPT and spIgE, were used for evaluated sensitization of allergen in patient. They guided the investigators for proper management as well as patient education. Clinician will use the result for choose allergen in case that might need immunotherapy.

SPT is safe and more economic for patient. Specific IgE has an advantage in patient who cannot withhold antihistamine prior SPT. In United state had a trial of result between SPT and spIgE for cockroach, cat, house dust mite and mold. It showed the correlation between two tests. In Thailand, the investigators haven't had data about it yet.

Detailed description: SPT and specific IgE for allergens is necessary for allergen avoidance and specific immunotherapy. To have local allergen extracts will help the patients to easier get the appropriate management

Eligibility criteria: Inclusion Criteria:

* Patient with controlled Asthma and/or AR (mild to moderate severity) who were diagnosed in Allergy clinic and ENT clinic, Siriraj hospital
* SPT positve one of American Cockroach, House dust mite, cat, dog and mold.
* Patient were consented to trial.

Exclusion Criteria:

* Chronic disease such as heart disease, liver, renal and severe sepsis
* History of anaphylaxis
* Skin rash
* Pregnancy

Primary outcomes:
measure: mean wheal diameter of SPT of local and imported allergen extracts and specific IgE levels
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Nualanong Visitsunthorn, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Worldwide variation in prevalence of symptoms of asthma, allergic rhinoconjunctivitis, and atopic eczema: ISAAC. The International Study of Asthma and Allergies in Childhood (ISAAC) Steering Committee. Lancet. 1998 Apr 25;351(9111):1225-32.
citation: Vichyanond P, Jirapongsananuruk O, Visitsuntorn N, Tuchinda M. Prevalence of asthma, rhinitis and eczema in children from the Bangkok area using the ISAAC (International Study for Asthma and Allergy in Children) questionnaires. J Med Assoc Thai. 1998 Mar;81(3):175-84.
Clinical trial NCT02696590: High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients
Official title: Isfahan University of Medical Sciences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapsing Remitting Multiple Sclerosis
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 200
Sex: ALL
Minimum age (years): 23
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level, the durability of the response, the practicality and the possible toxicity.

Detailed description: Ultraviolet sunlight is too low to produce adequate amounts of vitamin D3, and vitamin D insufficiency lasting 4 to 6 months of the year at latitudes of ≥42° is common in individuals with low vitamin D intake. Vitamin D has strong immunoregulatory effects, and vitamin D supplementation prevents experimental autoimmune encephalomyelitis (EAE), an autoimmune disease in animals that is used as a model of MS.

Recently, emerging data from epidemiologic studies suggest that vitamin D may play an important role in the progression of the development of MS. A longitudinal study in pediatric MS showed a 34% lower risk of relapse for every 10 ng/ml higher 25-hydroxyvitamin D level. A similar magnitude of reduced relapse risk was later reported in an adult MS cohort. Higher vitamin D levels have also been shown to be associated with less subsequent inflammatory MS activity on brain magnetic resonance imaging (MRI). Finally, studies have demonstrated that patients have lower vitamin D levels during MS relapses.

Eligibility criteria: Inclusion Criteria:

* with serum 25(OH)D3 concentration ≤ 20 ng/ml

Exclusion Criteria:

* hypercalcaemia, primary hyperparathyroidism, Paget disease, thyrotoxicosis, pregnancy, active malignancy, hypercalciuria, history of liver disease, renal insufficiency, clinically apparent malabsorption syndrome, using drugs containing vitamin D products, calcium, estrogen and drugs known to affect vitamin D metabolism (anticonvulsants, glucocorticoids) or receiving any form of supplements containing vitamin D during last 6 months.
* Participants with serum 25(OH)D concentration≥ 20 ng/ml

Primary outcomes:
measure: Serum concentration of 25(OH)D
timeFrame: Two Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Alzahra Hospital
Study officials:
affiliation: Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran
name: Masoud Etemadifar, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05853003: Neuromuscular Ultrasonography Assessment of Optic Nerve in Systemic Lupus Eryhematosus
Official title: Neuromuscular Ultrasonography Assessment of Optic Nerve in SLE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Optic Neuropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 140
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult SLE patients, who fulfilled Systemic Lupus International Collaborating Clinics classification criteria for SLE (SLICC) and another group of an apparently healthy subjects will be added to the study

Brief summary: assessing the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.

Detailed description: Evaluating the role of neuromuscular ultrasound in optic nerve involvement in systemic lupus patients.by measuring the diameter of optic nerve at certain site and comparing it to healthy subjects measurements and to asses NMUS ability to detect optic neuropathy in lupus patients in comparison to conventional techniques including opthalmologist evaluation and visual evoked potential

Eligibility criteria: Inclusion Criteria:

* Adult
* group of SLE patients, who fulfilled Systemic Lupus International Collaborating Clinics classification criteria for SLE (SLICC) with or without symptoms of optic neuropathy
* another group of apparently healthy subjects with no. history of chronic conditions

Exclusion Criteria:

* Any patient with optic neuritis due to causes other than lupus was excluded from the study: ex.

  * Post traumatic neuropathy
  * Purely degenerative neuropathy
  * Diabetic neuropathy
  * Toxic neuropathy
  * Neuropathies related to infections
  * Drug induced neuropathy e.g: quinine and some antibiotics, ethambutol
  * Infections e.g. measles, mumps, Lyme disease, etc.
  * Other Autoimmune diseases like sarcoidosis, B.D
  * Tumor causing Inc. intracranial tension.

Primary outcomes:
measure: comparing diameter (in mm2) of optic nerve in SLE patients and compare them to healthy subjects
timeFrame: over 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assuit university hospital
Study officials:
affiliation: Assiut University
name: Amira elsonbaty, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301703: Vaccination Against Pertussis, Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis
Official title: The Efficacy and Safety of Vaccination Against Pertussis. Tetanus and Diphtheria in Patients Suffering From Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid pertussis tetanus
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pertussis is an acute respiratory infection caused by Bordetella pertussis. Rates of recent B. pertussis infection between 8%--26% have been reported among adults with cough illness of at least 5 days duration who sought medical care. The CDC recommends vaccinating patients aged 15 to 64 years old, once in 10 years. Although acellular vaccines such as BOOSTRIX have been evaluated in healthy population, the safety and efficacy of this vaccine in patients suffering from rheumatic diseases have not been established.

Study population : 50 Rheumatoid Arthritis (RA) patients and 5 healthy controls

Evaluation : the evaluation will be performed on week 0 and 4-6 weeks later. In terms of safety, the patients will be evaluated according to the Disease Activity Index (DAS). Blood will be drawn at each visit at tested for humoral response to tetanus and pertussis.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from RA
* Aged 18 to 64 years old

Exclusion Criteria:

* Active disease requiring a change in drug regimen
* Known allergy to vaccine

Primary outcomes:
measure: Immunogenicity of Tdap in patients suffering from rheumatoid arthritis
timeFrame: 4-6 weeks after vaccination
Secondary outcomes:
measure: Safety of Tdap vaccine in RA patients
timeFrame: 4-6 weeks after vaccination
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Rheumatology, Tel Aviv Medical Center
Study officials:
References:
Clinical trial NCT00966303: Cardiac Rehabilitation in Cardiomyopathies
Official title: The Effectiveness of a Cardiac Rehabilitation in Patients With Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiomyopathies
Keywords: rehabilitation
dyspnea
strength
Lead sponsor: Fortaleza University
Sponsor class: OTHER
Collaborators: name: Edson Queiroz Foundation
First posted: 2009-08-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This quantitative study aimed to evaluate the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life in patients after cardiac rehabilitation associated with the diaphragmatic muscle training.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Cardiomyopathies in functional class III or IV (New York Heart Association)
* Aged over 18 years
* Body mass index below 30 kg/m2

Exclusion Criteria:

* Confused and depressed patients
* Cardiac instability and worsening dyspnea after initiation of treatment

Primary outcomes:
measure: The effectiveness of a cardiac rehabilitation in patients with cardiomyopathy, evaluating the respiratory muscle strength, pulmonary function, cardiovascular function, and impact on quality of life.
timeFrame: 8 weeks / Twice a week
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Fortaleza University - Nucleus of Integrated Medical Attention
state: Ceará
Study officials:
affiliation: Fortaleza University
name: Davi S Sales, Bachelor
role: PRINCIPAL_INVESTIGATOR
affiliation: Fortaleza University
name: Daniela GB Mont'Alverne, Doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00207103: MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Official title: Phase I Dose Escalation Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tumors
Neoplasm Metastasis
Keywords: Advanced metastatic or solid tumors
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of progressive advanced or metastatic (tumor that has spread) solid tumors
* No tumor spread to the brain
* Feeling well other than cancer diagnosis (i.e. lab work, no infection, etc.)
* Available tumor tissue sample from prior surgery
* 4-6 weeks since prior therapy and recovered from prior therapy
* Men and women, ages 18 and above
* Women must not be pregnant or breastfeeding
* Diagnosis of advanced or metastatic (tumor that has spread) colorectal, hepatocellular (liver) or renal (kidney) cancer
* Measurable disease on scans (at least one)

Primary outcomes:
measure: Safety assessment
timeFrame: throughout the study
measure: dose-limiting toxicity (DLT)
timeFrame: assessed for individual patients from C1D1 to C1D28 during the dose escalation portion of the protocol, until maximum tolerated dose is identified
measure: determination of maximum tolerated dose (MTD)
timeFrame: during dose escalation portion of the protocol. Three to six subjects are treated at a specified dose level. If deemed safe dose escalation continues until the maximum tolerated dose is identified
Secondary outcomes:
measure: Efficacy based on duration of response and time to progression based on assessment
timeFrame: measured every 8 weeks throughout the study
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
city: Indianapolis
country: United States
facility: Indiana University Med Center
state: Indiana
city: Madison
country: United States
facility: University Of Wisconsin Comprehensive Center
state: Wisconsin
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Milano
country: Italy
facility: Local Institution
city: Middlesex
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03171103: Systemic Lupus and Adverse Pregnancy Outcome
Official title: Systemic Lupus and Pregnancy Outcome in Benisuef Localities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Pregnancy Complications
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant ladies in Beni-suef localities diagnosed as systemic lupus

Brief summary: prospective analytical study of all pregnant ladies with systemic lupus in Beni-suef localities


Eligibility criteria: Inclusion Criteria:

* all pregnant ladies with settled diagnosis of systemic lupus

  * all pregnant ladies who first diagnosed as systemic lupus during current pregnancy

Exclusion Criteria:

-

Primary outcomes:
measure: maternal outcome
timeFrame: 3 years
Secondary outcomes:
measure: fetal outcome
timeFrame: 3 years
Other outcomes:
Locations:
city: Beni-suef
country: Egypt
facility: Faculty of Medicine
Study officials:
References:
Clinical trial NCT01236703: Hematological Infection Score Compared to the Hospital Standard for Diagnosis of SIRS or Sepsis on ICU
Official title: Hematological Infection Profile (ICIS/ICPS) Compared to Actual Best Hospital Practice for Differentiation of SIRS and Sepsis and Management of Antiinfective Therapy in ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SIRS
Sepsis
Keywords: SIRS
Sepsis
hematological infection score
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Sysmex Europe GmbH
First posted: 2010-11-09
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All IC department patients (WAN 8i, WAN 14i and WNC S1i Charite Berlin) will be enrolled in the study.

Brief summary: CRP and PCT are not valid parameters of early infection in particularly postoperative patients. (Sanders et al., A\&A, June 2006, Vol.102; Katja et al., Shock, February 2001, Vol 15.2) Better detection systems for SIRS and sepsis are urgently required.

ICIS® (Sysmex intensive care infection score) and ICPS® (Sysmex intensive care prognostic score) are two new score-systems depending on detectable cellular response of the innate immune system in human peripheral blood.

The purpose of this observational study is to determine if these scores are superior in early differentiation between non-infectious SIRS and infectious SIRS (sepsis) in postoperative patients. Furthermore, the applicability of the scores for triggering start and ending of anti-infective therapy will be examined.


Eligibility criteria: Inclusion Criteria:

* all ICU patients age \> 18 years
* more than 36h on ICU

Exclusion Criteria:

* ICU patients age \< 18 years
* less than 36h on ICU

Primary outcomes:
measure: The primary objective of this study performed according to an observational post-ad-hoc design is to show that the two Sysmex infection scores provide a better performance than CRP & PCT for infection processes thus providing an efficient alternative.
timeFrame: a period of 60 days
Secondary outcomes:
measure: The second objective is to investigate whether ICIS® and ICPS® could assist in faster antiinfective regim decisions than CRP & PCT.
timeFrame: a period of 60 day
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05286203: Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
Official title: Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uveitis
Infectious Disease
Keywords: Uveitis
Metagenomic deep sequencing
Intraocular infection
MDS
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: University of Nebraska
name: University of Utah
name: University of California, Davis
name: University of California, Los Angeles
First posted: 2022-03-18
Enrollment: 100
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: This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected.


Eligibility criteria: Inclusion Criteria:

* Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis
* Presumed post-operative endophthalmitis
* Unilateral or bilateral
* 18 years and older

Exclusion Criteria:

* Insufficient specimen for MDS
* Age \< 18 years of age
* Pregnancy
* Unable to consent

Primary outcomes:
measure: Clinical improvement
timeFrame: 4-week after randomization
measure: Appropriate therapy
timeFrame: 4-week after randomization
Secondary outcomes:
measure: Provider certainty of belief
timeFrame: 4-week after randomization
measure: Patient quality of life
timeFrame: 4-week after randomization
measure: Infection status
timeFrame: 4-week after randomization
measure: Provider quality of care
timeFrame: 4-week after randomization
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco (UCSF)
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thuy Doan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: