louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05946499: Evaluation of Vitamin A and E Deficiency With Severity of SARS-COV-2 Disease: A Case-Control Study
Official title: Correlation Between Vitamin A and E Deficiency With Severity of SARS-COV2 Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COVID=19 patients recruited from ICU (intensive care Unit) and chest ward

Brief summary: Coronavirus disease 2019 (COVID-19) is a novel infectious disease that has been spreading worldwide Coronaviridae study group of the International Committee on taxonomy of viruses (2020). The clinical manifestation of COVID-19 can range from asymptomatic infection to critical illness with severe pneumonia, respiratory failure, and death.

Vitamin A is of special interest in the field of infectious diseases, especially for pulmonary infections. It is crucial for the development of normal lung tissue and tissue repair after injury due to infection. Therefore, it may play a role in recovery after severe COVID-19 pneumonia. Vitamin A has immune regulatory functions and positively affects both the innate and adaptive immune cell response.

The anti-oxidant Vitamin E, and trace element selenium, are major components of anti-oxidant defense. Epidemiological studies demonstrate that deficiencies in, either of these nutrients, alters immune responses and viral pathogenicity.

Data concerning vitamin A and E plasma levels in COVID-19 patients are lacking. Therefore, this study aims at characterizing vitamin A and E plasma levels in COVID-19 and analyzing the association of plasma levels with disease severity and outcome.

Detailed description: The aim of the current study is to evaluate the relation of plasma level of Vitamin A and E and their correlation with severity of SARS-COV2 disease.

Eligibility criteria: Inclusion Criteria:

* COVID-19 positive patients by PCR (polymerase chain reaction) test
* Patients aging 18 to 75 years

Exclusion Criteria:

* Patients with known immunodeficiency - Patients with known lung diseases

Primary outcomes:
measure: Correlating between vitamin A and E deficiency and severity of SARS-COV2
timeFrame: From September 2021 to November 2022
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: balsam Sherif Fahmy
state: None Selected
Study officials:
References:
Clinical trial NCT01816399: New Vectorcardiogram Analysis a Good Predictor of Coronary Disease in Patients With Normal Rest 12-leads ECG
Official title: Spacial Relation of QRS-T Vectocardiogram is a Good Predictor of Coronary Disease in Patients With Normal Rest 12-leads ECG
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing routine coronary angiography

Brief summary: The aim of this study is to determine whether a new vectorcardiogram (VCG) analysis will facilitate the detection of significant coronary disease (CAD) in patients with normal rest 12-leads ECG (NE).

Detailed description: Patients with NE will undergo coronary angiography for routine indications. Prior to the angiography a computerized simultaneous multi-leads ECG will be recorded and, using a new dedicated algorithm for 3D electrical activity reconstruction, the investigators will plot the horizontal VCG of the whole ECG cycle. Using this new VCG analysis we will determine whether the patients have normal coronary arteries or coronary disease.

Eligibility criteria: Inclusion Criteria:

* Patients with normal rest 12-leads ECG

Exclusion Criteria:

* Patients with significant irregular heart beat
* Patients with heart failure

Primary outcomes:
measure: Detection of CAD in patients undergoing routine coronary angiography
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT01930799: Bladder Management in Patients With Multiple Sclerosis: Optimizing Practice Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Multiple Sclerosis
Urinary Bladder Diseases
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will assess the impact of a systematic bladder health screening and disease education regimen as well as the implementation of a referral process on the quality of life of multiple sclerosis patients with bladder dysfunction.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of relapsing-remitting multiple sclerosis and currently being treated by study doctor

Exclusion Criteria:

* Diagnosis of primary-progressive, secondary-progressive, or progressive-relapsing multiple sclerosis

Primary outcomes:
measure: Change From Baseline in the King's Health Questionnaire (KHQ) Domain Scores
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Percentage of Patients Who Agree/Completely Agree With Each Question on the Patient Post-Video Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Fresno
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01964599: Potato Fiber and Gastrointestinal Function: Phase 3
Official title: Potato Fiber and Gastrointestinal Function: Phase 3 (Grant #94521)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Symptoms
Gastrointestinal Transit Time
Stool Frequency
Keywords: Fiber
Gastrointestinal
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The primary physiological impacts of fiber intake include the gastrointestinal effects of stool bulking, increased stool frequency and decreased gastrointestinal transit time (GTT). Fermentation of resistant starches by microbiota increases bacterial numbers, which increases fecal bulk and may impact frequency and transit time. The purpose of this study is to determine the effects of resistant potato starches (potato fiber) on stool frequency, transit time and microbiota in healthy individuals.

Detailed description: Potato fiber (PF-RS, PF-RO1 and PF-RO2), supplemented in the diet of healthy individuals (n=60; 20 per group) and providing 30 g per day of fiber, will result in a significant changes in gastrointestinal function and microbiota profile.

Objectives:

1. To determine the effect of potato fibers on stool frequency, gastrointestinal transit time and gastrointestinal symptoms.
2. To determine the effect of potato fibers on microbial diversity in healthy individuals.

Eligibility criteria: Inclusion Criteria:

* must be between the ages of 18 and 65.
* must be willing to complete daily questionnaires.
* must be willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide SS#, but no financial reimbursement can be provided.
* must have internet access for the duration of the study
* must have usual fiber intake of \<20 g/d based on Food Frequency Questionnaire such as the Block Fruit/Vegetable/Fiber Screener
* must be willing to consume kool-aid everyday for 2 periods of 14 days
* must be willing to provide stool samples

Exclusion Criteria:

* must not have a physician-diagnosed gastrointestinal disease or condition (such as ulcerative colitis, Crohn's disease, gastroparesis, cancer, peptic ulcer disease, Celiac disease, short bowel disease, ileostomy, colostomy other than GERD, constipation, diverticular disease)
* must not have a food allergy
* must not take dietary supplements (prebiotic and fiber supplements)

Primary outcomes:
measure: Stool Frequency
timeFrame: 6 weeks
Secondary outcomes:
measure: Gastrointestinal transit time
timeFrame: 6 weeks
measure: Gastrointestinal symptoms
timeFrame: 6 weeks
measure: Microbial diversity
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Food Science & Human Nutrition Dept
state: Florida
Study officials:
affiliation: University of Florida
name: Wendy J Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04886570: Clinical Follow-up of Hip Arthroplasty: A Cross-section and Longitudinal Study
Official title: Clinical Follow-up of Hip Arthroplasty: A Cross-section and Longitudinal Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Arthropathy
Hip Replacement
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-05-14
Enrollment: 260
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects receiving hip arthroplasty in Taipei Veterans General Hospital meet the inclusion criteria can be considered to recruit

Brief summary: This longitudinal follow-up study aims to analyze how surgical and patient characteristics affect clinical outcomes in the subjects received total hip arthroplasty (THA) or hemiarthroplasty (HA).

Detailed description: Clinical assessments in this research include visual analogue scale (VAS), Harris Hip Score (HHS), Oxford Hip Score (OHS), forgotten joint score (FJS-12) and X-ray imaging applied to examine the stability of implants. Through analyzing surgical information, functional measures and self-reported questionnaires, this study intends to gain insights into the correlations between various clinical aspects.

Eligibility criteria: Inclusion Criteria:

1. 20 years old at least.
2. Osteoarthritis (OA)
3. Avascular necrosis
4. Rheumatoid arthritis (RA)
5. Previous failure of hemiarthroplasty
6. Femoral head or neck or trochanteric fractures
7. Developmental dysplasia of the hip

Exclusion Criteria:

1. Being unable or unwilling to participate in
2. Subjects having cognitive impairment cannot fill out survey
3. Other complication causing severe deficiency in function and motion

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
measure: Harris Hip Score
timeFrame: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
measure: Oxford Hip Score
timeFrame: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
measure: Forgotten Joint Score (FJS-12)
timeFrame: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
measure: Radiographic analysis
timeFrame: Pre-operation, 6 weeks, 12 weeks and 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of orthopedics, Taipei Veterans General Hospital, Taipei, Taiwan
name: Chieh-Szu Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00172770: The Establishment of the Early Intervention Program for Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Department of Health, Executive Yuan, R.O.C. (Taiwan)
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Schizophrenia is a severe mental illness, which has a prodromal phase of 1-2 years prior to the onset of the illness. During the prodromal phase, patients might show maladaptation and/or poor social functioning. However, these early symptom of schizophrenia might be overlooked by patients and their families. At that period, patients might strive to improve their social interactions and social functioning. However, the efforts might further create their stress level on everyday life, which can actually accelerate the illness onset of schizophrenia. In other words, the efforts would worsen the pathophysiologic changes in the brain, which can result in the positive symptoms of schizophrenia.

Previous researches found that the critical period for treatment of schizophrenia is the early phase of illness onset, especially the first two or three years. Delay treatment would worsen the illness. To this extent, early treatment would bring to a better prognosis as well as minimize the costs of individuals, families and society. In other words, early interventions not only can prevent relapse, it also can benefit patients' psychosocial adjustments. However, researches found that the average duration of untreated psychosis is 25.2 months in Taiwan, which indicates the phenomena of delay treatment and this trend might result in missing the critical treatment period.

This is a two years study aiming to establish an early intervention program for patients with schizophrenia. In the first year, it aims to understand the phenomena of psychiatric care services utilization for patients with schizophrenia, special emphasis will be on the delay treatment and pluralistic health seeking process. In the second year, it aims to establish an early intervention program. The results of this research would contribute to in-service trainings, service providing, and policy making of psychiatric services.


Eligibility criteria: Inclusion Criteria:

* patients with schizophrenia
* capable to express in Chinese
* willing to cooperate with

Exclusion Criteria:

* patients with schizophrenia but not willing to cooperate with

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ping-Chuan,Hsiung
Study officials:
affiliation: Department of Nursing, National Taiwan University
name: Ping-Chuan Hsiung, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01121770: "Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction"
Official title: Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-05-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine a preventative dose of study drug, Arixtra® for patients with kidney disease. We will measure the blood levels of Arixtra® in patients with kidney disease and develop guidelines for dosing.


Eligibility criteria: Inclusion Criteria:

* Inpatients who are 18 years or older
* estimated creatinine clearances between 20-50 ml/min
* current hospitalization for a cancer-related abdominal, breast surgery or elective orthopedic surgery
* able to give informed consent
* need for prophylactic anticoagulant therapy for increased risk of a thrombotic episode

Exclusion Criteria: Use of the following

* clopidogrel, aspirin, or NSAID usage,(usage is prohibited while patients are participating in the study)
* body weight \< 50 kg
* anticoagulation therapy for thrombosis or other indication
* pregnant or breast-feeding
* hypersensitivity to Arixtra®
* thrombocytopenia associated with a positive in vitro test for anti-platelet antibody in the presence of Arixtra®
* bacterial endocarditis
* brain malignancy
* increased risk of bleeding.

Primary outcomes:
measure: Blood samples to measure specific Arixtra® concentration
timeFrame: • Three blood samples for PK analyses will be obtained within the 24 hour period immediately following either the third or fourth consecutive dose of Arixtra
Secondary outcomes:
measure: Frequency of bleeding events and new thrombotic events
timeFrame: Daily assessments will be made for bleeding and thrombosis
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Thomas L Ortel, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03244670: The Incidence and Progression of Myopia: Cohort Study
Official title: A Cohort Study on Incidence and Progression of Myopia in a Group of Medical Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myopia
Keywords: Myopia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Essilor International
First posted: 2017-08-09
Enrollment: 350
Sex: ALL
Minimum age (years): 17
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First-year medical college student from Zhongshan University

Brief summary: A cohort study on incidence and progression of myopia in a group of medical students

Detailed description: A prospective cohort study to investigate the refractive error development, progression and their risk factors in young adult population comprises a group of medical students in China for two years

Eligibility criteria: Inclusion Criteria:

* Volunteer subject, , willing to follow the protocol and able to read, comprehend and sign the informed consent form,
* Age between 17 and 23 years

Exclusion Criteria:

* Vulnerability of the subject,
* Participation in another study which might have an influence on vision or interfere with study assessments,
* Aphakic or pseudophakic (intraocular lens)
* Participants who are wearing ortho-K lenses, or undergone any kind of myopia control treatments or undergone refractive surgery.
* Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with study assessments (e.g. AMD, glaucoma...),
* Any previous ocular surgery which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery...),
* Any untreated and/or uncontrolled systemic condition which might have an influence on vision, or interfere with study assessments (e.g. uncontrolled diabetes, uncontrolled high blood pressure...),
* Any medical treatment or medication which might have an influence on vision or interfere with study assessments (e.g. antidepressants, drugs with atropinic effects...),

Primary outcomes:
measure: refraction
timeFrame: Change from baseline for two years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Associate Professor
name: Chen xiang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00969670: Correlation of Particulate Matter and Heme Oxygenase-1 Protein Activity in Asthmatic Children by Induced Sputum Analysis.
Official title: Correlation of Particulate Matter and Heme Oxygenase-1 Protein Activity in Asthmatic Children by Induced Sputum Analysis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center

Brief summary: Samples of sputum from asthmatic children, between 5-17 years, will be collected during two years of the study period to perform tests Particle Size Distribution (PSD) and Shape Analysis (SA) of the particulate matter in the sputum and a biochemical reaction to evaluate the activity of Heme Oxygenase-1 protein in sputum cell supernatants.

Each child will perform Pulmonary Function Testing (PFT) and Induced Sputum (IS) as a routine part of diagnosis of asthma.

Parents will be asked to complete a questionnaire including questions on their child's respiratory symptoms in the last 12 months as well as socioeconomic factors. Parents will be asked to give informed written consent for their child's participation in the study.


Eligibility criteria: Inclusion Criteria:

* •All children, between 5-17 years, performing a routine diagnosis of asthma in Tel Aviv Sourasky Medical Center that there parents gave informed written consent for their child's participation in the study.

Exclusion Criteria:

* None.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Pulmonary Laboratory of Tel Aviv Sourasky Medical Center
Study officials:
References:
Clinical trial NCT01203670: Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
Official title: Renal and Digestive Tolerance of a Food Supplement, Phytalgic, in Elderly Volunteers - A Multicentric Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Tolerance
Digestive Tolerance
Keywords: Glomerular filtration rate (GFR)
Aspartate Amino Transferase (ASAT)
Alanine Amino transferase (ALAT)
gamma Glutamyl transpeptidase (gamma GT)
Lipase
Amylase
Lead sponsor: Phythea
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 70
Maximum age (years): 87
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the study is to evaluate renal and digestive tolerance of a food supplement, phytalgic, on elderly volunteers.


Eligibility criteria: Inclusion Criteria:

* 70 years old minimum
* Satisfying general health judged by principal investigator
* Pain and /or stifness associated with arthritis
* Regular used of analgesics and/or non-steroidal anti-inflammatory drugs (NSAIDs)
* Digestive tolerance biomarkers

  1. ASAT : Men \< 150 UI/L - Women \< 100 UI/L
  2. ALAT : Men \< 180 UI/l - Women \< 130 UI:l
  3. Gamma GT Men \< 180 UI/l - Gamma GT Women \< 100 UI/l
  4. Amylase \< 250 UI/l
  5. Lipase \< 750 UI/l
* Renal tolerance biomarker: Glomerular filtration rate (GFR)superior or equal to 60 mL /min / 1.73m3 - calculated with the "Modification of the Diet in Renal Diseases" formula

Exclusion Criteria:

* Inflammatory arthritis
* Allergy to any constituents of the study drug
* Types 2 diabetes
* Not legally fit to participate
* Any treatment able to modify determined biological parameters

Primary outcomes:
measure: Renal tolerance by Glomerular filtration rate (GFR) determination; Digestive tolerance by Aspartate Amino transferase (ASAT), Alanine Amino Transferase (ALAT), gamma Glutamyl Transpeptidase (gamma GT), lipase and amylase determination
timeFrame: 168 days
Secondary outcomes:
measure: Quality of life determined by Western Ontario and McMaster universities (WOMAC)Visual Analogue Scale(VAS)
timeFrame: 168 days
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Département de Pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - CHU de Bordeaux
Study officials:
affiliation: Département de pharmacologie Clinique - Université Victor Segalen Bordeaux 2 - Centre Hospitalo-Universitaire de Bordeaux
name: Alain JACQUET, MD
role: PRINCIPAL_INVESTIGATOR
References: