louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02377557: Observational Study to Assess Safety and Utility Pattern of Topical Steroids
Official title: Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Diseases
Keywords: Dermatologic Agent
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: Korean Ministry of Food and Drug Safety
name: College of Pharmacy, Seoul National University
First posted: 2015-03-03
Enrollment: 1175
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients or guardian of child purchased topical steroids in Korea

Brief summary: To assess incidence of adverse drug reactions and use pattern of topical steroids among patients who are prescribed or purchase over the counter (OTC) topical steroids for skin conditions in Korea

Detailed description: * Active collection of safety data, systemic and local adverse events.
* In addition to spontaneous adverse event reports, patients will be asked on occurrence of adverse events upon use of topical steroids at 1 month, 2 month, and 6 month after study enrollment by e-mail or phone call
* Causality of adverse events will be assessed by independent two professionals
* Document the utility pattern of topical steroid, misuse (inappropriate indication) or overuse (in terms of application frequency or treatment duration)
* Collection of information related with adverse event management

Eligibility criteria: Inclusion Criteria:

* All patients or guardian of child purchased topical steroids in Korea
* Informed consent to participate
* Willing to follow and abide by the protocol

Exclusion Criteria:

* None

Primary outcomes:
measure: Rate of adverse drug reaction upon use of topical steroid
timeFrame: 4 week after time of enrollment
Secondary outcomes:
measure: Rate of adverse drug reaction upon use of topical steroid
timeFrame: 2 month after time of enrollment
measure: Rate of adverse drug reaction upon use of topical steroid
timeFrame: 6 month after time of enrollment
measure: Rate of adverse drug reaction by potency, route of purchase (prescription/self diagnosed), drug classification (prescription only/over the counter)
timeFrame: 1 month after time of enrollment
measure: Rate of misuse and overuse of topical steroids
timeFrame: 6 month after time of enrollment
measure: Impact of covariates on incidence of adverse drug reaction
timeFrame: 6 month after time of enrollment
Other outcomes:
Locations:
city: Gyeonggi
country: Korea, Republic of
facility: College of Pharmacy, Hanyang University
Study officials:
affiliation: College of Pharmacy, Hanyang University
name: Ju-Yeun Lee, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00785057: Retrospective Treatment Pattern Survey for the Patient With and Without History of Stroke
Official title: A Retrospective, Multi Centre, Non-interventional, Observational Study to Compare Treatment Pattern and Factors That Affect BP Control in Patients With and Without Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Hypertension
Stroke
Neurology
JNC7
2007 ESH-ESC guidelines
survey
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-11-05
Enrollment: 1000
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: Hypertension outpatients coming to the Neurology Department

Brief summary: This study will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. It will evaluate target BP achievement rate in patients with stroke compared to patients without stroke and investigate factors affecting BP target goal efficacy in these patients.


Eligibility criteria: Inclusion Criteria:

* Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication

Exclusion Criteria:

* Secondary hypertension patients
* Patients not receiving hypertension medication

Primary outcomes:
measure: Blood pressure, History of stroke, Antihypertensive medication
timeFrame: After collecting all Patient Record Form.
Secondary outcomes:
measure: Blood pressure, History of stroke, antihypertensive medication, Classification of stroke, Risk factors, Concomitant medication, etc.
timeFrame: After collecting all Patient Record Form.
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Research Site
state: Gyeonggi
city: Sungnam
country: Korea, Republic of
facility: Research Site
state: Gyeonggi
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Kangwon
city: Busan
country: Korea, Republic of
facility: Research Site
city: Deagu
country: Korea, Republic of
facility: Research Site
city: Deajeon
country: Korea, Republic of
facility: Research Site
city: Kwangju
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Astrazenca Korea medical dept.
name: Joonwoo Bahn
role: STUDY_DIRECTOR
References:
Clinical trial NCT02848157: Effects of Dexmedetomidine as Adjunct to Pudendal Block for Pediatric Penile Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Elective Penile Surgeries
Hypospadias
Urethral Fistula or Stricture After Hypospadias Repair
Penile Curvature
Keywords: dexmedetomidine
pudendal block
hypospadias
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-07-28
Enrollment: 40
Sex: MALE
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Caudal block is often performed to relieve postoperative pain in pediatric urological surgery. Recently, pudendal block is also used in penile surgery and it has advantage because of less side effects such as transient weakness of low extremities, but limited to use in penile surgery. Local anesthesia is a single shot injection, so additional analgesic drugs is required when the effect of local anesthetics are disappeared. Dexmedetomidine, an alpha adrenergic agonist, is commonly used in pediatric sedation. It has analgesic effect and potentiates the effect of local anesthetics. There are many studies about the potentiation of the effect of local anesthetics when added to dexmedetomidine in adults, it has been limited in pediatrics. Recent study said that local anesthetics with dexmedetomidine had prolonged duration of analgesia in caudal block, also in ilioinguinal block. Thus it is expected to have a prolonged effect when investigators use dexmedetomidine in pediatrics as well as adults.


Eligibility criteria: Inclusion Criteria:

1. The patients aged between 6 months and 6 years in elective penile surgeries (hypospadias, urethral fistula or stricture after hypospadias repair, penile curvature)
2. American Society of Anesthesiologists (ASA) class I, II

Exclusion Criteria:

1. Coagulopathy
2. allergy to local anesthetics
3. meatal island onlay proximal transverse island flap (MIOPTI) (more than 4 h for the surgery)
4. illiteracy, foreigner

Primary outcomes:
measure: 1st analgesic request time
timeFrame: until 24 hours after surgery
Secondary outcomes:
measure: Postoperative pain evaluated by the FLACC scale
timeFrame: The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and 4, 8, 12, 24 h after the surgery.
measure: Emergence delirium evaluated by the pediatric anesthesia emergence delirium scale
timeFrame: The time of arrival in the recovery room, 10, 20, 30 min after arrival of the recovery room, and through the time of discharge from the PACU, an average of 30 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06974357: Evaluation of Genetic Abnormalities Amongst Calcium Phosphate Stone Formers
Official title: Evaluation of Genetic Abnormalities Amongst Calcium Phosphate Predominant Stone Formers With Alkaline Urine pH on 24 Hour Urine Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nephrolithiasis
Keywords: Urolithiasis
Calcium Phosphates
Genetics
Urine
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2025-05-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Kidney stones continue to affect more and more people in the United States with the most recent estimate being 1 in 9 people will develop a stone in their life. While family history is a known risk factor for stone disease, it remains unclear whether this is related to learned dietary habits or a truly inheritable genetic condition. Known inheritable genetic conditions linked to stone formation are uncommon, and thus, routine genetic testing is not currently recommended by any major urologic organizations. Patients who form calcium phosphate predominant stones, a less common type of stone composition, tend to have alkaline urine pH which suggests that the kidneys are unable to rid the body of acid. Management of such patients for stone prevention can be difficult. The Iowa Institute for Human Genomics is one of only a handful of commercial labs which offers genetic testing for stone disease. The aim of this study is to assess the rate of genetic abnormalities amongst calcium phosphate predominant stone formers with alkaline urine. To this end, the investigators plan to enroll calcium phosphate predominant stone forming patients with alkaline urine on 24 hour urine collection who obtain their health care at UIHC to undergo free genetic testing via blood draw to assess for genetic abnormalities. The investigators will also collect information already available in the subject's chart to assess for other patterns between blood and urine tests and any genetic variants.


Eligibility criteria: Inclusion Criteria:

* Any patient, aged 18-90 and not incarcerated, under the care of a urologist at UIHC with known kidney stone composition including \>=60% calcium phosphate and baseline 24 hour urine pH of \>=6.3

Exclusion Criteria:

- Any patient over the age of 90 years old, incarcerated or without any evidence of calcium phosphate stone composition

* No struvite component on prior stone analysis
* No bacteria with urease producing organism at time of stone removal
* No history or evidence of systemic acidosis
* No use of acetazolamide, topiramate, zonisamide, valproic acid
* Stage \>=3 CKD (GFR\<60)
* Hepatic disease
* Pregnancy
* History of osteoporosis

Primary outcomes:
measure: Rate of genetic variants
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References:
Clinical trial NCT02550457: Kinesio Taping on Chronic Nonspecific Low Back Pain
Official title: Effects of Kinesio Taping on Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study propose analyze the effects of Kinesio Taping® in chronic nonspecific low back pain. All the subjects will be submitted to an evaluation of the painful sensation, functional performance, trunk range of motion and neuromuscular performance at three different times.


Eligibility criteria: Inclusion Criteria:

* Female between 18 and 50 years of age with chronic nonspecific low back pain for more than three months.

Exclusion Criteria:

* Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
* Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
* Fibromyalgia
* Corticosteroid treatment in the previous two weeks;
* Antiinflammatory treatment in the previous 24 hours;
* Contraindications to the use of Kinesio Taping (allergy or intolerance);
* Score of two or less on Visual Analogue Scale of the first day;
* Pregnancy;
* Previous Kinesio Tape therapy on lumbar.

Primary outcomes:
measure: Painful sensation
timeFrame: Evaluation of pain sensation three days after the application of the tape.
Secondary outcomes:
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Universidade Federal do Rio Grande do Norte
state: Rio Grande Do Norte
Study officials:
References:
citation: Macedo LB, Richards J, Borges DT, Melo SA, Brasileiro JS. Kinesio Taping reduces pain and improves disability in low back pain patients: a randomised controlled trial. Physiotherapy. 2019 Mar;105(1):65-75. doi: 10.1016/j.physio.2018.07.005. Epub 2018 Jul 26.
Clinical trial NCT01390857: Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
Official title: Special Drug Use Investigation for VALTREX (Valaciclovir) (Pediatrics Chickenpox)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicella
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-07-11
Enrollment: 379
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Japanese pediatric patients with chickenpox (aged less than 15 years old)

Brief summary: The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of valaciclovir in pediatric patients with chickenpox


Eligibility criteria: Inclusion Criteria:

* Pediatric patients with chickenpox (aged less than 15 years old).

Exclusion Criteria:

* Patients with a history of hypersensitivity to the ingredients of valaciclovir or acyclovir.

Primary outcomes:
measure: Number of Participants With Any Serious Adverse Event
timeFrame: 1 month
Secondary outcomes:
measure: Number of Participants With the Indicated Adverse Drug Reactions
timeFrame: 1 month
measure: Number of Participants With Any Unexpected Adverse Drug Reactions
timeFrame: 1 month
measure: Number of Participants Classified as Effective and Not Effective
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02690857: Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)
Official title: Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 10
Sex: MALE
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status.

In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma and platelet lipid compositions will be determined.


Eligibility criteria: Inclusion Criteria:

* Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride \> 60 mmol/L and a pancreatic insufficiency.
* Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years
* Body weight \> 26 kg
* Stable CF disease as judged by the investigator.
* Subjects must have an Forced Expiratory Volume at one second \> 40 % of predicted normal for age, sex and height at the screening visit.
* Subjects should not have enteral or parenteral nutrition.
* No periodic IV lipidic emulsion administration. Subjects must not consume food supplements rich in OMEGA-3 on a regular basis.

Exclusion Criteria:

* Subjects with cirrhosis and portal hypertension.
* Subjects with Cystic fibrosis related diabetes.
* Concomitant participation in another clinical study.
* Known allergy or intolerance to the active principle.
* Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).
* Subjects on a transplant waiting list.

Primary outcomes:
measure: Change in 8-isoprostane level in urine.
timeFrame: Day 14
Secondary outcomes:
measure: Change in 11-dehydro-thromboxane B2 in urine.
timeFrame: Day 28
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Day 28
measure: Change in percent predicted forced expiratory volume in 1 second
timeFrame: from baseline through Day 28
measure: Evaluation of the effect of DHA on specific biomarkers.
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
References:
citation: Vericel E, Mazur S, Colas R, Delaup V, Calzada C, Reix P, Durieu I, Lagarde M, Bellon G. Moderate intake of docosahexaenoic acid raises plasma and platelet vitamin E levels in cystic fibrosis patients. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:41-47. doi: 10.1016/j.plefa.2016.10.008. Epub 2016 Oct 18.
Clinical trial NCT03444857: CPAP for OSA on Myocardial Salvage After pPCI for STEMI Patients
Official title: Effect of Continuous Positive Airway Pressure (CPAP) for Obstructive Sleep Apnea (OSA) on Myocardial Salvage After Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction: A Prospective, Multicenter, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
ST Elevation Myocardial Infarction
Keywords: Continuous Positive Airway Pressure
Myocardial Salvage
Obstructive Sleep Apnea
ST Elevation Myocardial Infarction
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized controlled trial to investigate the effects of CPAP treatment on myocardial salvage index and clinical outcomes at 3 months in patients with OSA and ST-Segment Elevation Myocardial Infarction (STEMI) after primary percutaneous coronary intervention (PPCI).


Eligibility criteria: Inclusion Criteria:

1. 18 to 80 years old
2. First-time STEMI
3. Successful PPCI (≥1 coronary artery) within 24h after symptom onset
4. Moderate to severe OSA (AHI≥15)
5. Written informed consent

Exclusion Criteria:

1. Prior myocardial infarction
2. Prior myocardial revascularization (PCI or CABG)
3. Cardiogenic shock (mean arterial pressure \<60mmHg), severe heart failure (Killip≥3)
4. LM or multivessel disease indicated for CABG
5. History of stroke
6. Severe insomnia, chronic sleep deprivation, abnormal circadian rhythm (sleep \<4h/night)
7. Severe COPD: FEV1/FVC \<70% or FEV1 \<50% predicted value (within 4 weeks)
8. Predominantly central sleep apnea (≥25% central events or central AHI ≥10/h)
9. Previous or current use of CPAP
10. Severe comorbidities: eg. malignancy (life expectancy \<2 years)
11. Known or planned pregnancy
12. Known contraindication to CMR
13. Patients with contraindication to CPAP or who cannot tolerate it
14. Participation in other clinical trial in recent 3 months
15. Any condition that in the opinion of investigator that may jeopardize patient compliance, eg. significant memory, perceptual, or behavioral disorder, depression, severe alcohol consumption, or a history of noncompliance

Primary outcomes:
measure: Myocardial salvage index
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
affiliation: Beijing Anzhen Hospital
name: Shao-Ping NIE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05830357: Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults
Official title: Prevalence and Risk Factors of Helicobacter Pylori Infection in Children and Young Adults in Sohag Governorate
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
dyspepsia
children
young adults
prevalence
peptic ulcer
risk factors
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-04-26
Enrollment: 667
Sex: ALL
Minimum age (years): 2
Maximum age (years): 25
Standard ages: CHILD
ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will be chosen by random sampling technique among children and young adults (between 2 to 25 years old) attending internal medicine and pediatric out- patient clinics at Sohag University hospital.

Brief summary: Helicobacter pylori is a gram-negative bacterium that resides in the stomach and can cause inflammation leading to long-term effects, such as gastric ulcers, cancer, and lymphoma of the stomach mucosal linings Previous research and analysis of H. pylori prevalence in populations have examined common risk factors that increase the likelihood of acquiring the bacteria. Some of the most commonly identified risk factors across various studies in different geographic populations are larger family size, less education, lower socioeconomic status, less frequent hygiene practices, and lower sanitation with specific emphasis on sources of water and defecation.

aim of the work: Studying prevalence of Helicobacter Pylori infection and its related risk factors in children and young adults in Sohag governorate.


Eligibility criteria: Inclusion Criteria:

* children and young adults (between 2 to 25 years old)

Exclusion Criteria:

* children below 2 years old
* adults more than 25 years old

Primary outcomes:
measure: Studying prevalence of Helicobacter Pylori infection in children and young adults in Sohag governorate
timeFrame: 12 weeks following the startpoint of the study.
Secondary outcomes:
measure: detecting risk factors related to Helicobacter Pylori infection in children and young adults in sohag governorate
timeFrame: 12 weeks following the startpoint of the study
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of medicine-Sohag university
Study officials:
References: