louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03266081: Bupivacaine Epiphora Trial
Official title: Improving Epiphora & Ptosis With Bupivacaine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Epiphora
Ptosis
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to investigate quantitative improvement in excessive tearing after administration of Bupivacaine, a local anesthetic, into the affected eyelids.


Eligibility criteria: Inclusion Criteria:

Patients age 18 and above, patients with unilateral or bilateral excessive tearing.

Exclusion Criteria:

Pregnant females, vulnerable populations, patients with severe hepatic disease, or patients using monoamine oxidase inhibitors or tricyclic antidepressants, which are contraindicated with bupivacaine and norepinephrine combinations.

Primary outcomes:
measure: Change from Baseline Lacrimal Tear Lake at 6 months
timeFrame: measurements at baseline and 6 months
Secondary outcomes:
measure: Change from baseline Lid distraction at 6 months
timeFrame: measurements at baseline and 6 months
measure: Change from baseline Lid snap back at 6 months
timeFrame: measurements at baseline and 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Albert Y Wu, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05472181: The Effects of Brain Stimulation on Speech Fluency in Adults Who Stutter
Official title: The Effects of Brain Stimulation on Enhancement of Speech Fluency in Adults Who Stutter
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stuttering, Adult
Keywords: TMS
Stuttering
Supplementary Motor Area (SMA)
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2022-07-25
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study uses a double-blinded between- and within-subjects crossover sham-controlled design across two different treatment phases to enhance the effects of behavioural training on stuttering.
Primary purpose: TREATMENT

Brief summary: The project is leading to investigate the effects of neuromodulation techniques on speech fluency among adults who stutter (AWS). While stuttering is responsive to a variety of treatments in childhood, this is not the case for AWS. Behavioural treatments to reduce stuttering for adults typically consist of speech restructuring methods, which involves the person using one of the altered speech patterns known to increase fluency, such as chorus reading, speaking in rhythm, and prolonging (smoothing/stretching out) speech sounds. Research has shown that behavioural interventions such as these change brain activation patterns in the regions associated with stuttering. Unfortunately, around 70% of AWS who receive these speech restructuring treatments do not maintain the benefits in the longer term and frequently re-present to speech clinics. The aim of this proposed research is to explore whether the brain stimulation using repetitive transcranial magnetic stimulation (rTMS) can consistently enhance effects of behavioural stuttering therapy by examining their responsiveness to the treatment across different outcome measures including a) immediate effect on different speaking contexts, and b) the maintenance of effects over one week after therapy.


Eligibility criteria: Inclusion Criteria:

- adults who stutter without any other speech, language or cognitive problems

Exclusion Criteria:

* have any history of neurological and other speech and language problems
* condition that are violating the safety criteria for TMS
* any history of epilepsy, and brain damage,
* having any metal plant or cardiac pace-maker in the body,
* current pregnancy

Primary outcomes:
measure: Stuttering severity
timeFrame: Immediately and one week after the treatment block
Secondary outcomes:
measure: Treatment satisfaction
timeFrame: one week after the treatment block
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: TMS Lab, Faculty of Education, The University of Hong Kong
Study officials:
References:
Clinical trial NCT00705081: Evaluation of the LDL-C Lowering Effects of Ezetimibe Achieved in Co-administration Therapy With Statins in an Indonesian Population (Study P04276)(COMPLETED)
Official title: Observational Study Evaluating the LDL-C Lowering Effects of Ezetimibe With a Statin as Prescribed in Daily Routine Practice in an Indonesian Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 453
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with hypercholesterolemia

Brief summary: The purpose of this study is to evaluate the safety and tolerability of the low-density lipoprotein-cholesterol (LDL-C) lowering in an Indonesian population treated with ezetimibe co-administered with a statin in routine daily practice. In addition, the study will investigate whether and to what extent the target levels set by the participating doctors are achieved by the co-administration therapy.

Detailed description: Sampling method: invitation to the physician's patients.

Eligibility criteria: Inclusion Criteria:

* All subjects that were to receive ezetimibe 10 mg as prescribed in daily practice

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Number of Participants Reporting Adverse Events
timeFrame: 4-6 weeks after the first visit
measure: Intensity of Adverse Events Reported
timeFrame: 4-6 weeks after the first visit
measure: Participants Achieving Low-density Lipoprotein-cholesterol (LDL-C) Target Levels With Co-administration Therapy
timeFrame: 4-6 weeks after the first visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01244581: Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
Official title: Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media, Suppurative
Keywords: middle ear effusion
amoxicillin-clavulanate
tympanometry
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-11-19
Enrollment: 84
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.


Eligibility criteria: Inclusion Criteria:

* Children with acute otitis media

Exclusion Criteria:

* Amoxicillin allergy
* Tympanic membrane perforation
* Tympanostomy tubes (current)
* Complication of acute otitis media such as mastoiditis

Primary outcomes:
measure: Time (days) to disappearance of middle ear effusion
timeFrame: Within 60 days
Secondary outcomes:
measure: Time (days) to disappearance of pain
timeFrame: Within 60 days
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Department of Pediatrics, Oulu University Hospital
city: Oulu
country: Finland
facility: Lääkärikeskus Mehiläinen
Study officials:
affiliation: University of Oulu
name: Matti Uhari, Professor
role: STUDY_DIRECTOR
affiliation: University of Oulu
name: Terhi Tapiainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, Pokka T, Alho OP, Uhari M. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr. 2014 Jul;168(7):635-41. doi: 10.1001/jamapediatrics.2013.5311.
Clinical trial NCT06103981: Acute Liver Injury in Patients With Pneumonia
Official title: Acute Liver Injury in Patients With Pneumonia and Its Impact on Hospital Stay and Outcome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Liver Injury
Pneumonia
Keywords: Acute Liver Injury
pneumonia
Covid19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-10-27
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with pneumonia in hospital ward or critical care

Brief summary: Acute liver injury (ALI) is defined as an acute derangement in liver function tests associated with liver-related coagulopathy, in the absence of underlying chronic liver disease.

A subset progress to acute liver failure ,Acute liver failure represent a more severe liver injury results in hepatic encephalopathy

Detailed description: Acute liver injury is associated with a spectrum of haemostatic changes, including thrombocytopenia and reduced platelet function, reduced plasma levels of many coagulation factors such as factor (F)VII and increased levels of FVIII .

Pneumonia is an acute inflammation of the lower respiratory tract. Lower respiratory tract infection is a major cause of mortality worldwide .Pneumonia is most common at the extremes of life.

In adults, pneumonia can be broadly classified, on the basis of chest radiographic appearance, into lobar pneumonia, bronchopneumonia and pneumonia producing an interstitial pattern.

There is lack of data regarding outcome and hospital stay in patients with pneumonia who develop acute liver injury.

Eligibility criteria: Inclusion Criteria:

1. Patients with pneumonia that developed Acute Liver Injury
2. Covid 19 pneumonia
3. Patients With acute liver injury only.

Exclusion Criteria:

1. Cancer
2. Immunocompromised patients i.e HIV patients and patients who take immunosuppressive medications.
3. Patients who younger than 18 yrs old
4. pregnancy

Primary outcomes:
measure: Impact of Acute liver injury due to Pneumonia
timeFrame: From Hospital admission date to Two Months
Secondary outcomes:
measure: Patients with Pneumonia only
timeFrame: From Hospital admission date to Two Months
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Faculty Of Medicine
Study officials:
affiliation: Assuit Faculty of Medicine
name: Zain Elabdeen Ahmed, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01006681: Vaccination Against Influenza H1N1 in Rheumatic Diseases
Official title: Efficacy and Safety of Vaccination Against Influenza H1N1 in Patients With Rheumatoid Arthritis, Systemic Lupus Erythematosus, Psoriatic Arthritis and Ankylosing Spondylitis Treated With Immunomodulatory Drugs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Influenza
Rheumatic Diseases
Keywords: rheumatoid
SLE
Psoriatic arthritis
Ankylosing
Influenza H1N1
Vaccine
Vaccination against H1N1 in rheumatic diseases
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-11-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The spread of Influenza H1N1 has prompted the development of vaccines against this virus. Immunocompromised patients are at increased risk of developing complications of Influenza H1N1. The efficacy and safety of H1N1 vaccination have not been evaluated in this population of patients.

Detailed description: 100 patients with Rheumatoid Arthritis (RA), 50 patients with Systemic Lupus Erythematosus (SLE), 50 patients with spondyloarthropathies (Psoriatic arthritis (PsA) and Ankylosing Spondylitis (AS) and 200 healthy subjects will participate in the study.

All the subjects will be vaccinated with Focetria (Novartis) and will be evaluated the day of vaccination and 4 weeks later.

The evaluation will include:

Efficacy of the vaccine: Blood will be drawn on day 0 and 4 weeks later and tested for the presence of antibodies against A/California17/2009/H1N1 by hemagglutination inhibition test.

Safety of the vaccine:

* Records of adverse event
* Assessment of disease activity : RA - Disease activity score (DAS 28), SLE - SLEDAI, PsA - DAS 28 and PASI, AS- BASDAI, ESR, CRP

Eligibility criteria: Inclusion Criteria:

* Patients suffering from: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Ankylosing Spondylitis, Psoriatic Arthritis
* Able to firm an informed consent
* Aged - 18-65
* Candidates to receive vaccination against H1N1, according to the recommendation of the Ministry of Health

Exclusion Criteria:

* Allergy to eggs
* Known allergy to seasonal influenza vaccine
* Pregnant women

Primary outcomes:
measure: Primary Endpoint : Proportion of patients who will achieve a titer of antibodies above 1/40 within the groups of patients in comparison with healthy subjects
timeFrame: 4 weeks
Secondary outcomes:
measure: Secondary Endpoint: Safety of the vaccine with regard to disease activity by changes in DAS, SLEDAI and BASDAI
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Elkayam O, Amir S, Mendelson E, Schwaber M, Grotto I, Wollman J, Arad U, Brill A, Paran D, Levartovsky D, Wigler I, Caspi D, Mandelboim M. Efficacy and safety of vaccination against pandemic 2009 influenza A (H1N1) virus among patients with rheumatic diseases. Arthritis Care Res (Hoboken). 2011 Jul;63(7):1062-7. doi: 10.1002/acr.20465.
Clinical trial NCT03537781: The Effect of Food Labelling and Satiety on Individuals Food Choice
Official title: Nutritional Knowledge and the Effects of Hunger & Satiety on Snack Choice: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Preferences
Hunger
Keywords: food choice, food labels
Lead sponsor: St Mary's University College
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to a food labelling or no food labelling condition. Participants in each condition will be tested when hungry and when satiated
Primary purpose: OTHER

Brief summary: Previous research has shown that nutritional knowledge is a key indicator in healthy eating choices, but real-life examinations of the associations between both nutritional knowledge and state of hunger and satiety on individuals' food choice of healthy vs unhealthy snacks is limited.

The present study aims to investigate whether the presence of nutritional information on food labels will affect participants' food choice when hungry and when satiated.

Detailed description: Previous research has shown that nutritional knowledge is a key indicator in healthy eating choices, but real-life examinations of the associations between both nutritional knowledge and state of hunger and satiety on individuals' food choice of healthy vs unhealthy snacks is limited.

As there is currently little research combining these facets, it would be interesting to investigate whether individuals who are provided with food labelling information would choose unhealthy snacks when hungry as than when satiated and whether this would differ for those who are not provided with food labelling information.

Based on this, the present study aims to investigate whether the presence of nutritional information in the form of food labels will affect participants' food choice when hungry and when satiated. The General Nutrition Knowledge Questionnaire will be used to assess participants baseline nutritional knowledge and will be used as a covariate in the research project.

Eligibility criteria: Inclusion Criteria: Male and females aged 18-65 years old; in general good health; not known allergies and any medical conditions (e.g. heart disease, asthma)

Exclusion Criteria: Those who are currently following a weight loss diet; have food allergies and any medical conditions which might restrict their food intake

Primary outcomes:
measure: food choice
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Marys University
Study officials:
affiliation: St. Mary's University, Twickenham
name: Conor Gissane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03588195: Educational Program for Knee Osteoarthritis
Official title: Evaluation of the Effectiveness of an Educational Program in Patients With Osteoarthritis of the Knee: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Education
Pain
Function
Quality of life
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Sixty patients with a diagnosis of knee osteoarthritis, aged between 40 and 80 years, of both genders were included. The patients were divided into: experimental group that carried out an educational program - 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes and the Transcutaneous Nerve Electro-Stimulation device - being performed twice weekly, for 5 weeks for 40 minutes each session; and control group who only underwent treatment with the Transcutaneous Nerve Electro-Stimulation in the same parameters as experimental group. The evaluations were performed at the beginning of the treatment, 4 and 12 weeks after the beginning of the treatment using a numerical pain scale; WOMAC; IDATE and SF-36 questionnaires; and 6-minute walk test.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of knee Osteoarthritis by American College of Rheumatology criteria;
* Age between 40 and 80 years;
* Both genders;
* Numerical Pain Scale in the knee between 3 and 8 centimeters on a scale of 0 to 10 centimeters.

Exclusion Criteria:

* Systemic inflammatory diseases or any condition that prevents the practice of physical activity;
* Regular physical activity started or changed in the last twelve weeks;
* No ambulation;
* Joint injection in the knee in the previous twelve weeks;
* Previous knee surgery or surgery planned for the next twenty-four weeks;
* Physiotherapy in the last twelve weeks;
* Other disease that affects the lower limbs;
* Open wounds at the electrode application site;
* Planned trip in the next twelve weeks.

Primary outcomes:
measure: Change in Pain
timeFrame: Baseline and after 4 and 12 weeks
Secondary outcomes:
measure: Change in function
timeFrame: Baseline and after 4 and 12 weeks
measure: Change in Anxiety
timeFrame: Baseline and after 4 and 12 weeks
measure: Change in Generic Quality of life
timeFrame: Baseline and after 4 and 12 weeks
measure: Change in Functional capacity
timeFrame: Baseline and after 4 and 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05002595: H. Pylori Treatment Between Modified Quadruple Regimen and Tailored Therapy
Official title: Comparison of Helicobacter Pylori Treatment Between Modified Quadruple Therapy and Tailored Eradication Based on the Presence of Clarithromycin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: H. Pylori Infection
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 270
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: H. pylori-infected patients

Brief summary: The rate of H. pylori resistance to antimicrobial agents including clarithromycin (CAM) has increased worldwide. Eradication failure using triple therapy is strongly associated with CAM-resistant H. pylori. The tailored therapy is defined as a targeted H. pylori eradication which emphasizes on predicting individual drug responses before treatment.

Dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) was developed to diagnose H. pylori infection and identify CAM resistance. The use of DPO-PCR has increased the tailored H. pylori eradication rate in Korea. If DPO-PCR testing is not available, a 14-day modified bismuth-containing quadruple regimen is recommended as a first-line H. pylori eradication. However, there is no comparison study between modified quadruple therapy and tailored eradication based on the presence of CAM resistance using DPO-PCR.

Detailed description: The investigators aim to evaluate the success rate, adverse drug events, and cost-effectiveness of modified quadruple therapy, compared with tailored eradication based on the presence of CAM resistance.

Eligibility criteria: Inclusion Criteria:

* Gastroscopy can be performed
* H. pylori test and pathological analysis can be performed

Exclusion Criteria:

* Age \< 20 or \> 80 years
* Anemia (serum hemoglobin level \< 10 g/dL)
* Severe systemic disease
* Advanced chronic liver disease
* Use of certain medications, including proton pump inhibitors, H2- receptor antagonists, or antibiotics
* History of H. pylori eradication
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding

Primary outcomes:
measure: H. pylori infection status
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Digestive Disease Center, Soonchunhyang University Hospital
Study officials:
affiliation: Soonchunhyang University Hospital
name: Jun-Hyung Cho, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho JH, Jin SY, Park S. Comparison of tailored Helicobacter pylori eradication versus modified bismuth quadruple therapy in Korea: a randomized controlled trial. Expert Rev Anti Infect Ther. 2022 Jun;20(6):923-929. doi: 10.1080/14787210.2022.2017280. Epub 2021 Dec 20.