louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00966121: Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol for the Prevention of Variceal Rebleeding
Official title: RCT Comparing the Efficacies of Endoscopic Variceal Ligation (EBL) and Combined Treatment of Beta-blocker and EBL for the Prevention of Esophageal Variceal Rebleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cirrhosis
Variceal Bleeding
Keywords: Cirrhosis
Esophagus Disorders
Varicose Veins
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2009-08-26
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Endoscopic Band Ligation (EBL) Versus Endoscopic Band Ligation and Propranolol
Primary purpose: PREVENTION

Brief summary: Both propranolol and endoscopic band ligation (EBL) are effective for prevention of variceal rebleeding. Recently several studies compared the efficacy of EBL alone and with a combination of propranolol and EBL. However, the results of recent studies showed discrepancy. This study is performed to compare the efficacy and safety of EBL alone and EBL combined with propranolol in patients without previous history of endoscopic variceal treatment.


Eligibility criteria: Inclusion Criteria:

* liver cirrhosis
* age between 18 and 70 years
* Successful control of esophageal variceal bleeding within 6 weeks before enrollment

Exclusion Criteria:

* Gastric variceal bleeding
* Patients with systolic blood pressure \<100 mmHg or basal heart rate \<60/min
* Portal vein thrombosis
* Prominent hepatic encephalopathy
* Coexisting untreated malignancy
* Severe cerebrovascular or cardiovascular disease, renal failure
* Previous history of endoscopic, radiologic, or surgical treatment for varices or ascites
* Contraindication to beta-blocker
* Pregnancy
* Refusal to give consent to participate in the trial

Primary outcomes:
measure: Rebleeding from esophageal varices
timeFrame: 2 years
Secondary outcomes:
measure: Upper gastrointestinal bleeding; significant esophageal variceal bleeding; mortality;adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References:
Clinical trial NCT00860821: A Methodology Study in Healthy Subjects to Evaluate the Effect of AZD8309 After Nasal Administration of Lipopolysaccharide (LPS)
Official title: A Randomised, Double-blind, Placebo-controlled, Two-way Crossover, Single-centre Methodologhy Study in Healthy Subjects to Evaluate the Effect of Oral Dosing With AZD8309 on Cells and Inflammatory Biomarkers in Nasal Lavage and Blood After Nasal Challenge With Lipopolysaccharide (LPS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy subjects
LPS
Effect
Intranasally
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this methodology study is to evaluate the effect of AZD8309 on cells and inflammatory biomarkers in nasal lavage and blood after nasal challenge with lipopolysaccharide (LPS)


Eligibility criteria: Inclusion Criteria:

* Healthy men or healthy, permanently sterilized, women aged 18 to 50 years inclusive, non-smokers or ex-smokers, Body Mass Index 18 to 30 kg/m2 and minimum body weight of 50 kg
* Blood neutrophil count above 2.2x10\^9/L

Exclusion Criteria:

* Clinical relevant disease and/or abnormality

Primary outcomes:
measure: Neutrophil numbers in nasal lavage
timeFrame: 3 times each in the end of two treatment periods
Secondary outcomes:
measure: Cells and inflammatory biomarkers in nasal lavage
timeFrame: 3 times in the end of the two treatment periods
measure: Cells and inflammatory biomarkers in blood
timeFrame: 2 times in the beginning and 5 times in the end of the two treatment periods
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Research Site
Study officials:
affiliation: Department of Otorhinolaryngology, Malmö University Hospital, Sweden
name: Lars Olaf Cardell
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca R&D Lund, Sweden
name: Leif Eriksson
role: STUDY_DIRECTOR
References:
citation: Leaker BR, Barnes PJ, O'Connor B. Inhibition of LPS-induced airway neutrophilic inflammation in healthy volunteers with an oral CXCR2 antagonist. Respir Res. 2013 Dec 16;14(1):137. doi: 10.1186/1465-9921-14-137.
Clinical trial NCT06632821: The Relationship Between Health Literacy, Physical Activity, Back Pain and Posture Habits in University Students
Official title: The Relationship Between Health Literacy, Physical Activity, Back Pain and Posture Habits in University Students
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: University Students
Keywords: university students
physical activity
back pain
posture habits
Lead sponsor: Muş Alparslan University
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 500
Sex: ALL
Minimum age (years): 17
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: university students

Brief summary: This study aims to investigate the relationship between health literacy, physical activity, back pain, and posture habits among university students. The Health Literacy Scale, the International Physical Activity Questionnaire, and the Posture Habits Questionnaire for Back Health in Daily Activities will be used to collect data from participants. Health literacy will be assessed in terms of individuals' ability to access, understand, and apply health-related information, while physical activity levels and posture habits will be examined for their influence on back pain. The findings are expected to shed light on the role of health literacy in promoting healthier physical activity and posture habits, providing insights for strategies to improve back health in this population.


Eligibility criteria: Inclusion Criteria:

* Being a university student

Exclusion Criteria:

* Having any diagnosed physical or psychological illness

Primary outcomes:
measure: Health Literacy Scale
timeFrame: one month
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: one month
measure: Posture Habits Questionnaire Related to Back Health in Daily Activities
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02114021: Effect of Betamethasone Gel and Lidocaine Jelly on Sore Throat, Cough and Hoarseness of
Official title: Effect of Betamethasone Gel and Lidocaine Jelly Applied Over Tracheal Tube Cuff on Post Operative Sore Throat, Cough and Hoarseness of Voice on the Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sore Throat
Cough
Keywords: Syndrome incidence after intubation
Betamethasone gel
lidocaine jelly
sore throat
cough
hoarseness of voice
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Islamic Azad University, Sanandaj
First posted: 2014-04-15
Enrollment: 99
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: ABSTRACT:

The aim of this study was to investigate the effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence. This study has not been carried out in Iran.

99 patients of either sex undergoing elective surgery were recruited in a single blind randomized study. The patients, using randomization table, were divided into three groups. Anesthetics and medications used during surgery were similar for all the patients.

For the all patients, the incidence of postoperative sore throat, cough and hoarseness of the voice in the different follow-up periods (1, 6 and 24 hours) based on the different types of medications were obtained.


Eligibility criteria: Inclusion Criteria:

1. 50 years\<age\>15 years
2. no acute upper respiratory infections and no sore throat
3. candidate for elective surgery unrelated to the throat
4. The lack of airways difficulties
5. candidate for general anesthesia with intubation
6. no contraindications for receiving steroid
7. surgery time \< 240 minutes
8. intubation up to 2 times
9. tracheal tube cuff pressure = 25-30 cm H2o
10. fasting for 8-6 hours prior to surgery
11. ASA I and ASAII and
12. Surgery under general anesthesia and endotracheal intubation

Exclusion Criteria:

1. use of nasogastric tube or throat packs
2. patients with upper respiratory tract infection
3. patients on steroid therapy were excluded from the study

Primary outcomes:
measure: sore throat
timeFrame: 24 hours after surgery
measure: cough
timeFrame: 1 hour after surgery
measure: hoarseness of voice
timeFrame: 1 hour after surgery
measure: sore throat
timeFrame: 1 hour after surgery
measure: sore throat
timeFrame: 6 hours after surgery
measure: cough
timeFrame: 6 hours after surgery
measure: cough
timeFrame: 24 hours after surgery
measure: hoarseness of voice
timeFrame: 6 hours after surgery
measure: hoarseness of voice
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Department of Anesthesiology, Booali Hospital, Islamic Azad University,
Study officials:
References:
Clinical trial NCT00567021: German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
Official title: German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Keywords: reflux
NSAR treatment
Patients with reflux symptoms or gastrointestinal symptoms after NSAR Treatment
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 67130
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Study population: PC and internist

Brief summary: This PMS study had the objective to evaluate under ordinary medical care conditions the efficacy and tolerability of esomeprazole in patients who where treated by general practitioners and internists.


Eligibility criteria: Inclusion Criteria:

* Patients with GERD, or NSAID related ulcers, who need treatment with esomeprazole.

Exclusion Criteria:

* Limitations; possible risks; warnings; contraindications mentioned in the SPC.

Primary outcomes:
measure: To gain further insight into the efficacy of esomeprazole under ordinary medical care conditions in consideration of diagnosis and type of NSAID therapy (if administered).
timeFrame: By estimating the proportion of treated subjects without any gastrointestinal symptoms at the end of the observational period 2. by assessing the change in intensity of gastrointestinal symptoms.
Secondary outcomes:
measure: To get further insight into the details of the use, dosage scheme and duration of treatment with esomeprazole in this population
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca Medical Department
name: Kai Richter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04387721: Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation
Official title: Influence of Residual Astigmatism on Visual Acuity in Patients Undergoing Cataract Surgery With Trifocal Intraocular Lens Implantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cataract After
Astigmatism
IOL
Visual Acuity
Keywords: CSF
Contrast Sensitivity
Trifocal IOL
Lead sponsor: Clinica Oftalmologica TACIR
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The field in which it will carry out the study is a private medical centre. TACIR Ophthalmology clinic is located in the TEKNON Medical Center in the city of Barcelona. The study population will be the patients of the TACIR ophthalmology clinic who will be operated on cataracts and agree to take part in the study.

Brief summary: MAIN OBJECTIVE: To assess the influence of residual astigmatism on visual acuity in the different lens foci in patients operated on for cataracts with a trifocal intraocular lens implant.

SECONDARY OBJECTIVE: To study the influence of residual astigmatism on the visual quality of the patient in the far focus and to determine if there are differences of affectation in the two study groups.

Detailed description: It will be studied how small residual astigmatisms after cataract surgery degrade the visual acuity of patients in the three focal planes of trifocal IOLs. Not only VA will be studied, but also visual quality through contrast sensitivity curves.

Eligibility criteria: Inclusion Criteria:

* Bilateral surgery performed by the same surgeon
* IOLs implanted IOLs FineVision (MicroF) and FineVision Toric (PodFT)
* Patients with pre-surgery corneal astigmatism less than 2.5 D
* Patients whose pupillary diameter in physiological position (conditions of lower photopic pupil) not over 4 mm.

Exclusion Criteria:

* Post-surgical refractive residual astigmatisms ≧ 1.55D
* Previous corneal or intraocular surgeries
* Active diseases
* Eye complications during the 3-month follow-up

Primary outcomes:
measure: Visual Acuity
timeFrame: 3 months following cataract surgery
measure: Contrast Sensitivity Function (CSF)
timeFrame: 3 months following cataract surgery
Secondary outcomes:
measure: Differences between groups
timeFrame: 3 months following cataract surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Clinica Oftalmológica TACIR
Study officials:
affiliation: Clinica Oftalmologica TACIR
name: Enrique Ordiñaga-Monreal, OD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01561521: An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Akorn, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-23
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion Criteria:

* known contraindications or sensitivities to the study medication or its components
* any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters
* use of disallowed medication during the period indicated prior to the enrollment or during the study

Primary outcomes:
measure: Ocular Itching at defined time points up to 2 weeks
timeFrame: Baseline to day 14
measure: Ocular Redness at defined time points up to 2 weeks
timeFrame: Baseline to day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT00316121: Safety and Efficacy Study of Healos as a Bone Replacement to Treat Degenerative Disc Disease
Official title: A Prospective, Multicenter, Randomized Study Comparing the Use of HEALOS® to Autograft in a Transforaminal Lumbar Interbody Fusion (TLIF) Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Degenerative Disc Disease
Keywords: One or Two Level Degenerative Disc Disease
Lead sponsor: Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Sponsor class: OTHER
Collaborators: name: DePuy Spine
First posted: 2006-04-20
Enrollment: 138
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: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of HEALOS compared with autograft using the transforaminal lumbar interbody fusion (TLIF) method.


Eligibility criteria: Inclusion Criteria:

* Persistent back and/or leg pain refractory to 6 months of non-surgical therapy
* Male or female 18 to 70 years of age (inclusive)
* Objective evidence of significant disc degeneration at one or two adjacent lumbar level(s) from L2/L3 to L5/S1

Exclusion Criteria:

* Significant disc degeneration at more than two adjacent levels
* Greater than Grade II spondylolisthesis
* Prior fusion surgery of the lumbar spine (prior discectomies and intradiscal electrothermal therapy \[IDET\] are allowed)
* Insulin-dependent diabetes mellitus
* Pregnant or lactating, or wishes to become pregnant within the 24 month duration of the study

Primary outcomes:
measure: Subject Success (Success is Defined Only if All of These Criteria Are Fulfilled)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Brandon
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Annapolis
country: United States
state: Maryland
city: Billings
country: United States
state: Montana
city: Williamsville
country: United States
state: New York
city: Norwood
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Temple
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Spokane
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
Study officials:
References:
Clinical trial NCT04534621: How Brazilian Chiropractors Are Facing the COVID-19 Pandemic
Official title: How Brazilian Chiropractors Are Being Affected and What Strategies They Have Developed for Facing the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: chiropractors
strategies
coronavirus
pandemic
Lead sponsor: Trate - Tratamentos Especializados
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 948
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All chiropractors from the Brazilian Chiropractic association database / thru social media / principal investigator database will be invited to participate.

Brief summary: Brazil has the Latin America's largest coronavirus outbreak, numbers second only to the United States in the western hemisphere. The first COVID-19 confirmed case in Brazil was on February of 2020. A 61yrs old man tested positive after returning from a trip to Italy. Few other very first cases were also imported from Europe by returning travelers. The first locally transmitted case was registered on March of 2020, when a total of 8 cases have already been confirmed. At the time the WHO declares the outbreak as a pandemic (March 11) Brazil had 52 confirmed cases being 6 of those locally transmitted.

Healthcare professionals are now more important than ever. Given the intrinsic nature of the hands-on treatment of the Chiropractic profession, it is extremely important to understand what strategies chiropractors have put in place to address patient care, safety, and self report COVID contamination of those professionals.


Eligibility criteria: Inclusion Criteria:

* Chiropractors graduated from national or international accredited colleges.

Exclusion Criteria:

* Chiropractors who did not treated patients in 2020.

Primary outcomes:
measure: What measures have been implemented to avoid SARS-COV2 transmission when taking care of patients, during the COVID-19 pandemic.
timeFrame: 2 weeks
Secondary outcomes:
measure: Professionals SARS-COV2 infection rates.
timeFrame: 2 weeks
measure: Professional financial impact.
timeFrame: 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Trate
name: MARCELO B BOTELHO, DC, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04594421: Change Trend of Effluent Eosinophil During Peritoneal Dialysis-Related Peritonitis
Official title: Study on the Increasing Proportion and Change Trend of Eosinophil in Peritoneal Fluid During Peritoneal Dialysis-Related Peritonitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peritonitis
Keywords: Peritonitis
eosinophil
peritoneal dialysis
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients on peritoneal dialysis

Brief summary: A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. This study will provide evidence for routine eosinophil testing

Detailed description: A multi-center prospective cohort study will be conducted to explore the change trend of eosinophil in peritoneal dialysis effluent during peritoneal dialysis-associated peritonitis, and to explore the relationship between eosinophil increase, peritonitis severity and antibiotic use. In this study, 100 patients with peritoneal dialysis-associated peritonitis who meet the inclusion criteria will be selected. Demographic data, laboratory variables, peritoneal fluid cytology and bacterial culture will be collected within 24 hours of peritonitis (day 1). Peritoneal fluid cytology includes leukocyte classification and eosinophilic leukocyte count will be examined at day 3, 5, 7, 10, 14, 21, 30, 60 and 90 after peritonitis. All patients will be followed up for 90 days, and their peritonitis outcome will be recorded. The primary endpoint is the prevalence of eosinophil increase in peritoneal effluent, which is defined as \>100 eosinophils/mm\^3, or \>10% eosinophils of the total non-erythrocyte count. Secondary end points are peritonitis outcome at month 1 and 3 including transfer to hemodialysis , death.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as peritoneal dialysis-related peritonitis;
* Age\> 14 years
* Maintenance peritoneal dialysis due to end-stage renal failure ≥3 months
* Use of lactate glucose dialysate

Exclusion Criteria:

* Those who cannot be followed up regularly
* Reluctant to join this researcher

Primary outcomes:
measure: Prevalence of elevated eosinophils in peritoneal dialysis effluent
timeFrame: Feb 18,2021 to December 31,2023
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renal Division and Institute of Nehprology,Peking University First Hospital
state: Beijing
Study officials:
References: