louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04433689: Corneal Biomechanics During Pregnancy
Official title: Change in Corneal Biomechanics During Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Keywords: pregnancy
corneal biomechanical properties
intraocular pressure
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy pregnant women with uncomplicated singleton pregnancy

Brief summary: It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

Detailed description: It is known that intraocular pressure changes during pregnancy. Collagen structure changes during pregnancy to enable softening of the symphysis, whitening of the birth chanel, and, thus, ultimately to enable delivery of a child. The cornea consists of highly structured collagen fibers. Hence, it seams logically that corneal biomechanics also change during pregnancy.

Measurement of intraocular pressure is highly dependant on corneal properties. With the Corvis ST device by Ocular Inc. it is possible to measure intraocular pressure and investigated corneal biomechanics. The aim of this study is therefore to compare corneal biomechanical properties during the third trimester with corneal biomechanical properties at 3 months after delivery.

Eligibility criteria: Inclusion Criteria:

* females
* pregnant
* age 18 to 38 yo
* uncomplicated singleton pregnancy

Exclusion Criteria:

* any history of ocular disease or surgery other than conjunctivitis, especially no history of glaucoma or corneal disease
* systemic diseases, i.e. diabetes, hypertension, collagenase
* current contact lens wear
* before pregnancy taking any systemic or ocular medications

Primary outcomes:
measure: Change in Deformation Amplitude
timeFrame: at 3 month post delivery compared to during third trimester
measure: Change in Applanation Length
timeFrame: at 3 month post delivery compared to during third trimester of the pregnancy
measure: Change in Corneal Velocity
timeFrame: at 3 month post delivery compared to during third trimester of the pregnancy
measure: Change in corneal thickness
timeFrame: at 3 month post delivery compared to during third trimester of the pregnancy
measure: Change in Intraocular pressure
timeFrame: at 3 month post delivery compared to during third trimester of the pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Department of Ophthalmology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Dpt. of Ophthalmology
name: Marc Toeteberg-Harms, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06950489: Tegoprazan and Amoxicillin Dual Therapy
Official title: A Feasibility Study of Tegoprazan and Amoxicillin Dual Therapy for the Treatment of Helicobacter Pylori
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: H.Pylori Infection
Lead sponsor: Soonchunhyang University Hospital
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 50
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: Dual therapy for Helicobacter pylori refers to a treatment regimen that combines two agents: a potent acid suppressor (such as a proton pump inhibitor \[PPI\] or a potassium-competitive acid blocker \[PCAB\]) and the antibiotic amoxicillin. This approach is increasingly recognized as a viable alternative to traditional triple or quadruple therapies, particularly in the context of rising resistance to other antibiotics such as clarithromycin and metronidazole. Potent acid suppression increases the stability and activity of amoxicillin against H. pylori by maintaining a higher gastric pH, which is essential for optimal amoxicillin effect. High-dose dual therapy (e.g., amoxicillin 1,000 mg three times daily + standard dose of PPI three or four times daily for 14 days) has demonstrated eradication rates of 90%. In 2015, vonoprazan, a novel P-CAB, was launched in Japan and used as an alternative for PPIs for eradicating H. pylori. Dual therapy with vonoprazan and amoxicillin is particularly effective, with cure rates comparable to triple therapy and superior outcomes in clarithromycin-resistant infections. Dual therapy is generally well tolerated, with adverse event rates similar to or lower than those seen with triple or quadruple regimens. In 2018, a new P-CAB, tegoprazan, was developed in Korea and approved for H. pylori eradication. However, there was no study of tegoprazan and amoxicillin dual therapy for the treatment of H. pylori.

Detailed description: The investigators aim to evaluate the H. pylori eradication success rate and treatment compliance of tegoprazan and amoxicillin dual therapy.

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
* Drug allergy to antibiotics
* History of gastric surgery
* Recent history of upper gastrointestinal bleeding

Primary outcomes:
measure: H. pylori eradication rates
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Digestive Disease Center, Soonchunhyang University Hospital
Study officials:
References:
Clinical trial NCT05210829: The Association Between Parent Anxiety and Sedation Anesthesia Doses in Pediatric Endoscopy
Official title: The Association Between Parent Anxiety and Sedation Anesthesia Doses in Pediatric Endoscopy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anxiety
Anesthesia
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents.

Brief summary: Our study was planned as a prospective, single-center study between 20 January 2022 and 20 April 2022. All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study. All patients and parents whose family did not give consent to participate in the study will be excluded from the study. All patients will be seen by an anesthesiologist before the procedure and it will be stated that there is no harm in taking anesthesia. Anesthesia consent form will be given by the family. Study participation consent will be obtained from parents before starting the procedure. The patient's age, gender, height, weight, ASA score, the procedure to be performed, the parent's educational status, occupation and income level will be recorded. Children's anxiety will be evaluated with the "Modified Yale Preoperative Anxiety Scale (mYPAS)" in the presence of their parents 15-30 minutes before the procedure. The agitation that occurs when the patient leaves the families for processing, with the "Parental Separation Anxiety Scale"; Parental anxiety will be evaluated with the "Stationary and Trait Anxiety Scale" filled by families after the child is processed.


Eligibility criteria: Inclusion Criteria:

* All patients between the ages of 1-18 who will undergo upper or lower gastrointestinal endoscopy and their parents will be included in our study.

Exclusion Criteria:

* All patients and parents whose family did not give consent to participate in the study will be excluded from the study.

Primary outcomes:
measure: Anesthesia agent dose
timeFrame: end of the gastrointestinal endoscopy
Secondary outcomes:
measure: Children's anxiety
timeFrame: before gastrointestinal endoscopy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03633929: mHealth for Patient Self-Management of Opioid Use Disorder
Official title: mHealth for Patient Self-Management of Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Lead sponsor: Biomedical Development Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Twenty individuals diagnosed with opioid use disorder

Brief summary: Twenty individuals diagnosed with opioid use disorder (OUD) will be recruited to participate in a beta test to demonstrate feasibility of using an online tool to help them better self-manage their recovery.

Detailed description: Participants will be enrolled in a 4-week single group pre-post evaluation. All participants will attend a two hour orientation to complete baseline assessments, learn how to access and use the software, and participate in a training session. Study participants will be asked to complete assessments online at least three times per week, but no more than once daily. The software may still be accessed by participants as many times as desired to review advice and graphs. After the four week evaluation phase, participants will return for a two hour debriefing and completion of assessment surveys. This approach permits users to be adequately trained while also evaluating the software within their typical environment rather than in a lab setting.

Eligibility criteria: Inclusion Criteria:

1. male or female outpatients 18 years of age or older;
2. opioid use disorder as assessed by MINI 6.0;
3. currently stable in OUD outpatient treatment for 4 weeks or longer; and
4. ability to access KIOS-OUD via computer, smartphone, or tablet.

Exclusion Criteria:

1. are unwilling or unable to comply with study requirements;
2. have a major untreated psychiatric illness (e.g., schizophrenia, bipolar disorder) or suicidality.

Primary outcomes:
measure: Usability Score
timeFrame: Usability was assessed at end of the study, at 4 weeks
Secondary outcomes:
measure: Opioid Use
timeFrame: 4 weeks
measure: Mean Change in Depression Score From Baseline
timeFrame: This instrument was administered at baseline and at the end of the study (4 weeks)
measure: Change in World Health Organization Quality of Life Assessment From Baseline
timeFrame: This instrument was issued at baseline and at the end of study (4-weeks)
measure: Mean Change on Patient-entered Data From KIOS App
timeFrame: baseline 4-weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Biomedical Development Corporation
state: Texas
city: San Antonio
country: United States
facility: Community Medical Services
state: Texas
Study officials:
affiliation: Consultant
name: Karla Ramirez, LCSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00294229: Spinal Manipulative Therapy for Low Back Pain
Official title: Spinal Manipulative Therapy for Low Back Pain: Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Low back pain
Spinal manipulative therapy
Randomised controlled trial
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Swiss Society for Manual Therapy (SAMM)
name: Insel Gruppe AG, University Hospital Bern
name: Wissenschaftlicher Fonds WFR
First posted: 2006-02-20
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Context: Acute low back pain (LBP) is a common reason for consultations in primary care. Reducing the pain in the first hours and days and restoring the functional capacity of the lumbar spine may result in a decrease in medical costs and earlier return to work.

Objective: To determine the impact of spinal manipulation on pain and analgesic use in acute low back pain.

Detailed description: Design: Randomised controlled parallel-group trial comparing standard care plus spinal manipulative therapy with standard care alone. Intention-to-treat analysis.

Patients: Outpatients with acute low back pain. Setting: Emergency Department of Bern University Hospital and a primary care practice network.

Eligibility criteria: Inclusion criteria:

1. Age between 20 and 55 years
2. Duration of acute low back pain less than 4 weeks
3. Informed consent

Exclusion criteria:

1. Pregnancy
2. Radicular origin of back pain (with irradiation)
3. Cauda equine syndrome
4. Neurologic deficit
5. Epidural glucocorticoid injections in the preceding three months
6. Previous low back surgery
7. Severe osteoporosis
8. Blood-coagulation disorder
9. Allergy to planned rescue medications
10. Suspicion of a specific cause of low back pain (fracture, tumor, infection, inflammatory disease of the spine, HIV-infection) in the patient's history or by physical examination
11. History or signs of severe dysfunction of the liver or kidney

Primary outcomes:
measure: Back pain overall measured by a numeric rating scale(range 0 to 10)
measure: Analgesic use based on daily equivalence doses (paracetamol, diclofenac and codeine)
Secondary outcomes:
measure: Roland Morris Score
measure: Serious adverse events
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Social and Preventive Medicine (ISPM), University of Bern
Study officials:
affiliation: Dep. of Rheumatology & Clinical Immunology/Allergology, University Hospital of Berne
name: Peter M. Villiger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Social and Preventive Medicine (ISPM), University of Berne
name: Peter Juni, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02774629: Efficacy of Local Food Extracts at Different Storage Times
Official title: Efficacy of Local Lyophilized Food Extracts for Skin Prick Tests and Atopy Patch Test at Different Storage Times (0, 3 and 6 Months)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Food Allergy
Keywords: food allergy
skin prick test
atopy patch test
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Food allergy cases aged 3-18 years old.

Brief summary: Local lyophylized food extracts are available useful in skin prick test and atopy patch test to confirm food allergy. However, the investigators want to know the duration that the investigators can keep the extracts for the usage in this purpose.

Detailed description: Food allergy incidence increases world wide. The diagnosis mostly depends on history. Skin prick test and atopic patch test are useful in finding the causative foods in some cases. The local food extracts have been shown to be at least as effective as commercial ones. From previous study the investigators keep the extract at 2-8 degree Celsius for 1-3 months for the usage. The investigators want to evaluate the duration that the extracts are still useful in diagnosis food allergy

Eligibility criteria: Inclusion Criteria:

* Positive skin prick test to one of the food (milk, egg, soy, wheat, seafood)

Exclusion Criteria:

* Chronic diseases such as heart disease, liver, renal and severe sepsis
* Severe allergic symptoms such as anaphylaxis
* Extensive skin rashes
* Pregnancy

Primary outcomes:
measure: Mean wheal diameter of skin prick test
timeFrame: 2 years
Secondary outcomes:
measure: Result of atopy patch test
timeFrame: 2 years
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj hospital
Study officials:
affiliation: Mahidol University
name: Nualanong Visitsunthorn, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06172829: Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line
Official title: Clinical Validation of Suntech Advantage MX With Suntech Neonate and Children Cuff Line Against Invasive Intra-arterial Reference According to the ANSI/AAMI/ISO 810602-2019 Protocol for Neonates, Infants, Children
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Hypertension
Lead sponsor: SunTech Medical
Sponsor class: NETWORK
Collaborators: name: Children's Hospital Los Angeles
First posted: 2023-12-15
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study is only accepting neonate and pediatric patients who meet the inclusion criteria.

Brief summary: Patients will be selected according to specific criteria. Upon selection, patients with an existing intra-arterial line will have their blood pressure monitored with the SunTech Advantage MX module in addition to the reference data collected from intra-arterial line. Data collected from the Advantage MX module will be compared to the reference data from the intra-arterial line.


Eligibility criteria: Inclusion Criteria:

* At least 3 subjects shall be \< 1,000g in weight.
* At least 3 subjects shall be 1,000g to 2,000g in weight.
* At least 3 subjects shall be \>2,000g
* At least 3 subjects shall be ≥ 29 days and \< 1 year of age.
* At least 3 subjects shall be ≥ 1 year and \< 3 years of age.

Exclusion Criteria:

* Subjects who study personnel determine invasive blood pressure measurements will be unreliable
* Patients found to have a-fib, irregular heart rhythm, dysrhythmias, bigeminy, trigeminy, and isolated premature ventricular beats (VPBs) during the enrollment process are to be ineligibile to participate in the study
* Patients who are prescribed anti-coagulation medication during the enrollment process or begin anti-coagulation medication after enrollment are ineligible to participate in the study.
* Exclusions can also occur post-data review based on exclusion criteria according to ANSI/AAMI/ISO 81060-2:2019

Primary outcomes:
measure: The blood pressure measurement
timeFrame: approximately 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
Study officials:
References:
Clinical trial NCT03242629: Comparison Between Oral and Enema of Chloral Hydrate
Official title: Effects Comparison Between Oral and Enema of Chloral Hydrate in Pediatric Ophthalmic Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Cataract
Keywords: pediatric ophthalmic examination
chloral hydrate
Effects Comparison
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.The patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).

Detailed description: To compare the clinical sedative effect and safety using 10% chloral hydrate during ophthalmic examinations for oral vs enema group.The patients were randomly divided into two groups (oral group and enema group) using a computer random number generator with a 1:1 allocation (simple randomization, odd number for oral group and even number for enema group).One hundred and twenty children aged from 3 to 36 months (5-15 kg) scheduled to ophthalmic examinations were randomly sedated by oral chloral hydrate(80 mg×kg-1, n = 60) or enema chloral hydrate(80 mg×kg-1, n = 60). The primary endpoint was successful sedation to complete the examinations including slit-lamp photography, tonometry, anterior segment analysis, and refractive error inspection. The secondary endpoints included onset time, duration of examination, recovery time, discharge time, any side effects during examination, and within 48 h after discharge.

Eligibility criteria: Inclusion Criteria:

* diagnosed with congenital cataract aged from 3 to 36 months weight from 5 to 15 kg with American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion Criteria:

* with gastro-esophageal reflux, nausea and vomiting, apnea in the past 3 months recent pneumonia exacerbation of asthma, bronchitis and upper respiratory tract infection bradycardia, and facial abnormalities, allergy to chloral hydrate, weight \<2 or \>20 kg .

Primary outcomes:
measure: Demography (age, sex, weight， laterality and medical history)
timeFrame: baseline
Secondary outcomes:
measure: Side effect
timeFrame: the following 48 hour after using the drug
measure: the time of Sleepiness:Onset time (min）
timeFrame: baseline
measure: the time of Sleepiness:Duration of examination (min)
timeFrame: baseline
measure: the time of Sleepiness:Recovery time (min)
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Haotian Lin, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: